Topic: Intervention

Abstract

Clinical outcomes of drug-coated balloon in coronary lesions: a real-world, all-comers study.

Pan L, Lu W, Han Z, Pan S, ... Huang Z, Qiu C
Backgrounds
Although drug-eluting stents are the most common interventional devices for patients with coronary disease, drug-coated balloons (DCBs) represent a novel therapeutic alternative in certain scenarios. This prospective, observational all-comers study explored the clinical outcomes of DCB use in patients with coronary lesions.
Methods and results
All patients treated with DCBs were enrolled in this study, including patients with in-stent restenosis (ISR) or de novo lesions. The primary outcome was the target lesion revascularization (TLR) rate at one year. We enrolled 2306 patients with 2660 lesions and performed DCB angioplasty in 399 patients (17.3%) with ISR and 1907 patients (82.7%) with de novo lesions. During follow-up (366 ± 46 days), the TLR rate was lower in the de novo lesion group (1.31%) compared to the ISR group (7.02%) [odds ratio (OR) 0.176, 95% confidence interval (CI) 0.101-0.305, p < 0.001]. Patients with de novo lesions had a lower yearly incidence of MACE compared to ISR patients (2.73 vs. 9.27%, respectively, OR 0.274, 95% CI 0.177-0.424, p < 0.001) and a lower incidence of any revascularization (5.09 vs. 13.03%, OR 0.358, 95% CI 0.251-0.510, p < 0.001). No significant differences between groups were observed in the rates of cardiac death (OR 0.783, 95% CI 0.258-2.371, p = 0.655) or MI (OR 0.696, 95% CI 0.191-2.540, p = 0.573).
Conclusions
DCB angioplasty in this all-comers, real-world, prospective study was safe and efficient with low TLR and MACE rates. Thus, DCB appears to be an attractive alternative for the stent-less treatment of de novo coronary lesions. ISR in-stent restenosis; OR odds ratio; CI confidence interval; TLR target lesion revascularization; MACE major adverse cardiovascular events; MI myocardial infraction. MACE defined as the composite outcome of cardiac death, myocardial infarction, and target vessel revascularization. Any revascularization includes any percutaneous coronary intervention, and coronary artery bypass grafting.

© 2021. Springer-Verlag GmbH Germany, part of Springer Nature.

Clin Res Cardiol: 01 Jul 2022; 111:732-741
Pan L, Lu W, Han Z, Pan S, ... Huang Z, Qiu C
Clin Res Cardiol: 01 Jul 2022; 111:732-741 | PMID: 34313800
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Abstract

Human coronary microvascular contractile dysfunction associates with viable synthetic smooth muscle cells.

Dora KA, Borysova L, Ye X, Powell C, ... Smart N, Ascione R
Aims
Coronary microvascular smooth muscle cells (SMCs) respond to luminal pressure by developing myogenic tone (MT), a process integral to the regulation of microvascular perfusion. The cellular mechanisms underlying poor myogenic reactivity in patients with heart valve disease are unknown and form the focus of this study.
Methods and results
Intramyocardial coronary micro-arteries (IMCAs) isolated from human and pig right atrial (RA) appendage and left ventricular (LV) biopsies were studied using pressure myography combined with confocal microscopy. All RA- and LV-IMCAs from organ donors and pigs developed circa 25% MT. In contrast, 44% of human RA-IMCAs from 88 patients with heart valve disease had poor (<10%) MT yet retained cell viability and an ability to raise cytoplasmic Ca2+ in response to vasoconstrictor agents. Comparing across human heart chambers and species, we found that based on patient medical history and six tests, the strongest predictor of poor MT in IMCAs was increased expression of the synthetic marker caldesmon relative to the contractile marker SM-myosin heavy chain. In addition, high resolution imaging revealed a distinct layer of longitudinally aligned SMCs between ECs and radial SMCs, and we show poor MT was associated with disruptions in these cellular alignments.
Conclusion
These data demonstrate the first use of atrial and ventricular biopsies from patients and pigs to reveal that impaired coronary MT reflects a switch of viable SMCs towards a synthetic phenotype, rather than a loss of SMC viability. These arteries represent a model for further studies of coronary microvascular contractile dysfunction.

© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.

Cardiovasc Res: 29 Jun 2022; 118:1978-1992
Dora KA, Borysova L, Ye X, Powell C, ... Smart N, Ascione R
Cardiovasc Res: 29 Jun 2022; 118:1978-1992 | PMID: 34173824
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Abstract

Vascular histopathology and connective tissue ultrastructure in spontaneous coronary artery dissection: pathophysiological and clinical implications.

Margaritis M, Saini F, Baranowska-Clarke AA, Parsons S, ... Sheppard MN, Adlam D
Aims 
Spontaneous coronary artery dissection (SCAD) is a cause of acute coronary syndromes and in rare cases sudden cardiac death (SCD). Connective tissue abnormalities, coronary inflammation, increased coronary vasa vasorum (VV) density, and coronary fibromuscular dysplasia have all been implicated in the pathophysiology of SCAD but have not previously been systematically assessed. We designed a study to investigate the coronary histological and dermal collagen ultrastructural findings in SCAD.
Methods and results
Thirty-six autopsy SCAD cases were compared with 359 SCAD survivors. Coronary and myocardial histology and immunohistochemistry were undertaken. Transmission electron microscopy (TEM) of dermal extracellular matrix (ECM) components of n = 31 SCAD survivors and n = 16 healthy volunteers were compared. Autopsy cases were more likely male (19% vs. 5%; P = 0.0004) with greater proximal left coronary involvement (56% vs. 18%; P < 0.0001) compared to SCAD survivors. N = 24 (66%) of cases showed no myocardial infarction on macro- or microscopic examination consistent with arrhythmogenic death. There was significantly (P < 0.001) higher inflammation in cases with delayed-onset death vs. sudden death and significantly more inflammation surrounding the dissected vs. non-dissected vessel segments. N = 17 (47%) cases showed limited intimal fibro-elastic thickening but no features of fibromuscular dysplasia and no endothelial or internal elastic lamina abnormalities. There were no differences in VV density between SCAD and control cases. TEM revealed no general ultrastructural differences in ECM components or markers of fibroblast metabolic activity.
Conclusions 
Assessment of SCD requires careful exclusion of SCAD, particularly in cases without myocardial necrosis. Peri-coronary inflammation in SCAD is distinct from vasculitides and likely a reaction to, rather than a cause for SCAD. Coronary fibromuscular dysplasia or increased VV density does not appear pathophysiologically important. Dermal connective tissue changes are not common in SCAD survivors.

© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.

Cardiovasc Res: 22 Jun 2022; 118:1835-1848
Margaritis M, Saini F, Baranowska-Clarke AA, Parsons S, ... Sheppard MN, Adlam D
Cardiovasc Res: 22 Jun 2022; 118:1835-1848 | PMID: 34048532
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Abstract

Risk predicting for acute coronary syndrome based on machine learning model with kinetic plaque features from serial coronary computed tomography angiography.

Wang Y, Chen H, Sun T, Li A, ... Wang X, Cao F
Aims
More patients with suspected coronary artery disease underwent coronary computed tomography angiography (CCTA) as gatekeeper. However, the prospective relation of plaque features to acute coronary syndrome (ACS) events has not been previously explored.
Methods and results
One hundred and one out of 452 patients with documented ACS event and received more than once CCTA during the past 12 years were recruited. Other 101 patients without ACS event were matched as case control. Baseline, follow-up, and changes of anatomical, compositional, and haemodynamic parameters [e.g. luminal stenosis, plaque volume, necrotic core, calcification, and CCTA-derived fractional flow reserve (CT-FFR)] were analysed by independent CCTA measurement core laboratories. Baseline anatomical, compositional, and haemodynamic parameters of lesions showed no significant difference between the two cohorts (P > 0.05). While the culprit lesions exhibited significant increase of luminal stenosis (10.18 ± 2.26% vs. 3.62 ± 1.41%, P = 0.018), remodelling index (0.15 ± 0.14 vs. 0.09 ± 0.01, P < 0.01), and necrotic core (4.79 ± 1.84% vs. 0.43 ± 1.09%, P = 0.019) while decrease of CT-FFR (-0.05 ± 0.005 vs. -0.01 ± 0.003, P < 0.01) and calcium ratio (-4.28 ± 2.48% vs. 4.48 ± 1.46%, P = 0.004) between follow-up CCTA and baseline scans in comparison to that of non-culprit lesion. The XGBoost model comprising the top five important plaque features revealed higher predictive ability (area under the curve 0.918, 95% confidence interval 0.861-0.968).
Conclusions
Dynamic changes of plaque features are highly relative with subsequent ACS events. The machine learning model of integrating these lesion characteristics (e.g. CT-FFR, necrotic core, remodelling index, plaque volume, and calcium) can improve the ability for predicting risks of ACS events.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.

Eur Heart J Cardiovasc Imaging: 01 Jun 2022; 23:800-810
Wang Y, Chen H, Sun T, Li A, ... Wang X, Cao F
Eur Heart J Cardiovasc Imaging: 01 Jun 2022; 23:800-810 | PMID: 34151931
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Abstract

Aortic enlargement and coronary artery calcification in a general population cohort.

Ballegaard CR, Pham MHC, Sigvardsen PE, Kühl JT, ... Køber LV, Kofoed KF
Aims
The role of atherosclerosis in the pathogenesis of aortic enlargement is uncertain. We aimed to evaluate the relationship between the diameters of the ascending, descending and abdominal aorta, and coronary artery calcification.
Methods and results
Individuals in the Copenhagen General Population Study underwent thoracic and abdominal computed tomography. Maximal aortic diameters were measured in each aortic segment and coronary artery calcium scores (CACS) were calculated. Participants were stratified into five predefined groups according to CACSs and compared to aortic dimensions. The relation between aortic diameter and CACS was adjusted for risk factors for aortic dilatation in a multivariable model. A total of 2678 eligible individuals were included. In all segments of the aorta, aortic diameter was associated to CACSs, with mean increases in aortic diameters ranging from 0.7 to 3.5 mm in individuals with calcified coronary arteries compared to non-calcified subjects (P-value < 0.001). After correction for risk factors, individuals with CACS above 400 had larger ascending, descending and abdominal aortic diameter than the non-calcified reference group (P-value < 0.01).
Conclusion
Enlarged thoracic and abdominal aortic vascular segments are associated with co-existing coronary artery calcification in the general population.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.

Eur Heart J Cardiovasc Imaging: 01 Jun 2022; 23:855-862
Ballegaard CR, Pham MHC, Sigvardsen PE, Kühl JT, ... Køber LV, Kofoed KF
Eur Heart J Cardiovasc Imaging: 01 Jun 2022; 23:855-862 | PMID: 34166489
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Impact:
Abstract

Anxa1 in smooth muscle cells protects against acute aortic dissection.

Zhou C, Lin Z, Cao H, Chen Y, ... Pan B, Zheng L
Aims
Acute aortic dissection (AAD) is a life-threatening disease with high morbidity and mortality. Previous studies have showed that vascular smooth muscle cell (VSMC) phenotype switching modulates vascular function and AAD progression. However, whether an endogenous signalling system that protects AAD progression exists remains unknown. Our aim is to investigate the role of Anxa1 in VSMC phenotype switching and the pathogenesis of AAD.
Methods and results
We first assessed Anxa1 expression levels by immunohistochemical staining in control aorta and AAD tissue from mice. A strong increase of Anxa1 expression was seen in the mouse AAD tissues. In line with these findings, micro-CT scan results indicated that Anxa1 plays a role in the development of AAD in our murine model, with systemic deficiency of Anxa1 markedly progressing AAD. Conversely, administration of Anxa1 mimetic peptide, Ac2-26, rescued the AAD phenotype in Anxa1-/- mice. Transcriptomic studies revealed a novel role for Anxa1 in VSMC phenotype switching, with Anxa1 deficiency triggering the synthetic phenotype of VSMCs via down-regulation of the JunB/MYL9 pathway. The resultant VSMC synthetic phenotype rendered elevated inflammation and enhanced matrix metalloproteinases (MMPs) production, leading to augmented elastin degradation. VSMC-restricted deficiency of Anxa1 in mice phenocopied VSMC phenotype switching and the consequent exacerbation of AAD. Finally, our studies in human AAD aortic specimens recapitulated key findings in murine AAD, specifically that the decrease of Anxa1 is associated with VSMC phenotype switch, heightened inflammation, and enhanced MMP production in human aortas.
Conclusions
Our findings demonstrated that Anxa1 is a novel endogenous defender that prevents AAD by inhibiting VSMC phenotype switching, suggesting that Anxa1 signalling may be a potential target for AAD pharmacological therapy.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.

Cardiovasc Res: 06 May 2022; 118:1564-1582
Zhou C, Lin Z, Cao H, Chen Y, ... Pan B, Zheng L
Cardiovasc Res: 06 May 2022; 118:1564-1582 | PMID: 33757117
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Abstract

Rationale and design of the pragmatic clinical trial tREatment with Beta-blockers after myOcardial infarction withOut reduced ejection fracTion (REBOOT).

Rossello X, Raposeiras-Roubin S, Latini R, Dominguez-Rodriguez A, ... Ibáñez B, REBOOT-CNIC investigators
Aims
There is a lack of evidence regarding the benefits of β-blocker treatment after invasively managed acute myocardial infarction (MI) without reduced left ventricular ejection fraction (LVEF).
Methods and results
The tREatment with Beta-blockers after myOcardial infarction withOut reduced ejection fracTion (REBOOT) trial is a pragmatic, controlled, prospective, randomized, open-label blinded endpoint (PROBE design) clinical trial testing the benefits of β-blocker maintenance therapy in patients discharged after MI with or without ST-segment elevation. Patients eligible for participation are those managed invasively during index hospitalization (coronary angiography), with LVEF >40%, and no history of heart failure (HF). At discharge, patients will be randomized 1:1 to β-blocker therapy (agent and dose according to treating physician) or no β-blocker therapy. The primary endpoint is a composite of all-cause death, non-fatal reinfarction, or HF hospitalization over a median follow-up period of 2.75 years (minimum 2 years, maximum 3 years). Key secondary endpoints include the incidence of the individual components of the primary composite endpoint, the incidence of cardiac death, and incidence of malignant ventricular arrhythmias or resuscitated cardiac arrest. The primary endpoint will be analysed according to the intention-to-treat principle.
Conclusion
The REBOOT trial will provide robust evidence to guide the prescription of β-blockers to patients discharged after MI without reduced LVEF.

© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.

Eur Heart J Cardiovasc Pharmacother: 05 May 2022; 8:291-301
Rossello X, Raposeiras-Roubin S, Latini R, Dominguez-Rodriguez A, ... Ibáñez B, REBOOT-CNIC investigators
Eur Heart J Cardiovasc Pharmacother: 05 May 2022; 8:291-301 | PMID: 34351426
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Abstract

Safety and feasibility of intravascular ultrasound guided zero-contrast percutaneous coronary intervention-A prospective study.

Nandhakumar V, Pakshirajan B, Chopra A, Anandan H, ... Victor SM, Ajit MS
Background
There are published reports of safety and feasibility of percutaneous coronary intervention (PCI) without contrast, using intravascular ultrasound (IVUS) and coronary physiology guidance in chronic kidney disease population. We prospectively evaluated the safety and feasibility of zero-contrast PCI technique.
Methods
In this prospective study, we hypothesized that PCI is feasible without contrast, using IVUS guidance alone without mandatory coronary physiology to rule out slow-flow or no-flow at the end of PCI in a population at risk of contrast-induced acute kidney injury (CI-AKI). In this study, we included 31 vessels in 27 patients at risk of CI-AKI and assessed the primary outcome of technical success at the end of PCI. Major adverse cardio-cerebro vascular events (MACCE) and percent change in estimated glomerular filtration rate(eGFR) one month after PCI were the secondary outcomes of the study.
Results
The primary outcome was met in 87.1%(n = 27) of the procedures. Technical failure was seen in 12.9%(n = 4) of the procedures. None of the patients developed MACCE at one-month follow-up. The median percent change in eGFR at one-month follow-up was -8.19%(-24.40%, +0.92%). There was no newer initiation of renal replacement therapy at one-month follow-up.
Conclusions
Zero-contrast PCI is safe and feasible in selective coronary anatomies with IVUS guidance. Coronary physiology is not mandatory to rule out slow-flow or no-flow at the end of procedure. Contrast may be needed to tide over the crisis during the possible complications, namely slow-flow, geographical miss and intraprocedural thrombus.

Copyright © 2022 Elsevier B.V. All rights reserved.

Int J Cardiol: 15 Apr 2022; 353:22-28
Nandhakumar V, Pakshirajan B, Chopra A, Anandan H, ... Victor SM, Ajit MS
Int J Cardiol: 15 Apr 2022; 353:22-28 | PMID: 35065155
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Abstract

Remote ischemic preconditioning can extend the tolerance to extended drug-coated balloon inflation time by reducing myocardial damage during percutaneous coronary intervention.

Zhao Z, Shi Q, Guo Q, Peng L, ... Rao L, Li M
Background
Remote ischemic preconditioning (RIPC) alleviates myocardial ischemia-reperfusion injury (IRI) that occurs during percutaneous coronary intervention (PCI) and increases the myocardial tolerance to ischemia and hypoxia. Prolonged inflation time of drug-coated balloons (DCBs) can improve the treatment effects of PCI and the long-term prognosis of patients. This study investigated whether preoperative RIPC improves the tolerance to extended DCB inflation time.
Methods and results
Overall, 345 patients with coronary artery disease (CAD) were enrolled; 90, 96, 83, and 76 of these were randomized into the upper limb RIPC, lower limb RIPC, upper limb control, and lower limb control groups, respectively. Their baseline data were collected. Data on cardiac markers were analyzed. The DCB inflation time was recorded. The baseline data and cardiac marker levels before operation did not differ between RIPC and control groups. The post-PCI high-sensitivity troponin-T levels were lower in the RIPC groups (35.81 ± 14.02 and 34.65 ± 14.86 pg/mL) than in the control groups (41.63 ± 18.31 and 42.24 ± 14.38 pg/mL) (P = 0.001). The DCB inflation tolerance time was higher in the lower limb RIPC group (120 s [120,120]) than in the upper limb RIPC group (120 s [110,120]), and was the lowest in the upper limb control (100 s [90, 120]) and the lower limb control (100 s [90, 115]) groups (P < 0.001).
Conclusions
RIPC reduces the level of myocardial damage that occurs during PCI and prolongs tolerance to increased DCB inflation time. The larger the ischemic area in RIPC, the better the improvement in the tolerance to extended DCB inflation time.

Copyright © 2022. Published by Elsevier B.V.

Int J Cardiol: 15 Apr 2022; 353:3-8
Zhao Z, Shi Q, Guo Q, Peng L, ... Rao L, Li M
Int J Cardiol: 15 Apr 2022; 353:3-8 | PMID: 35092760
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Abstract

Unraveling the Multitude of Etiologies in Myocardial Infarction With Nonobstructive Coronary Arteries.

Pustjens TFS, Vranken NPA, Hermanides RS, Rasoul S, Ottervanger JP, Van\'t Hof AWJ
Although recent studies revealed suboptimal outcomes in patients with myocardial infarction with nonobstructive coronary arteries (MINOCAs), the underlying etiology remains unknown in most patients. Therefore, adequate treatment modalities have not yet been established. We aimed to assess demographics, treatment strategies, and long-term clinical outcome in MINOCA subgroups. We retrospectively analyzed data from a large, prospective observational study of patients with acute coronary syndrome admitted to the Isala hospital in Zwolle, The Netherlands between 2006 and 2014. Patients with MINOCA were divided into subgroups based on the underlying cause of the event. From 7,693 patients, 402 patients (5%) concerned MINOCA. After the exclusion of missing cases (n = 47), 5 subgroups were distinguished: \"true\" acute myocardial infarction (10%), perimyocarditis (13%), cardiomyopathy (including Takotsubo cardiomyopathy) (19%), miscellaneous causes (21%), and an indeterminate group (38%). Patients with cardiomyopathy were predominantly women (78%) and showed the highest incidence of major adverse cardiovascular events at 30 days follow-up (7%; p = 0.012), 1 year (19%; p = 0.004), and mortality at long-term follow-up (27%; p = 0.010) compared with any other MINOCA subgroup. The cardiomyopathy group was followed by the indeterminate group, with major adverse cardiovascular events rates of 1% and 5%, respectively, and 17% long-term all-cause mortality. In conclusion, long-term prognosis in MINOCA depends on the underlying etiology. Prognosis is worst in the cardiomyopathy group followed by the indeterminate group. This underlines the importance of revealing the diagnosis to ultimately optimize treatment.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am J Cardiol: 01 Apr 2022; 168:17-21
Pustjens TFS, Vranken NPA, Hermanides RS, Rasoul S, Ottervanger JP, Van't Hof AWJ
Am J Cardiol: 01 Apr 2022; 168:17-21 | PMID: 35031111
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Abstract

Relation of Iron Status to Prognosis After Acute Coronary Syndrome.

Gürgöze MT, Kardys I, Akkerhuis KM, Oemrawsingh RM, ... Manintveld OC, Boersma E
Iron deficiency has been extensively researched and is associated with adverse outcomes in heart failure. However, to our knowledge, the temporal evolution of iron status has not been previously investigated in patients with acute coronary syndrome (ACS). Therefore, we aimed to explore the temporal pattern of repeatedly measured iron, ferritin, transferrin, and transferrin saturation (TSAT) in relation to prognosis post-ACS. BIOMArCS (BIOMarker study to identify the Acute risk of a Coronary Syndrome) is a prospective, multicenter, observational cohort study conducted in The Netherlands between 2008 and 2015. A total of 844 patients with post-ACS were enrolled and underwent high-frequency (median 17) blood sampling during 1 year follow-up. Biomarkers of iron status were measured batchwise in a central laboratory. We analyzed 3 patient subsets, including the case-cohort (n = 187). The primary endpoint (PE) was a composite of cardiovascular mortality and repeat nonfatal ACS, including unstable angina pectoris requiring revascularization. The association between iron status and the PE was analyzed using multivariable joint models. Mean age was 63 years; 78% were men, and >50% had iron deficiency at first sample in the case-cohort. After adjustment for a broad range of clinical variables, 1 SD decrease in log-iron was associated with a 2.2-fold greater risk of the PE (hazard ratio 2.19, 95% confidence interval 1.34 to 3.54, p = 0.002). Similarly, 1 SD decrease in log-TSAT was associated with a 78% increased risk of the PE (hazard ratio 1.78, 95% confidence interval 1.17 to 2.65, p = 0.006). Ferritin and transferrin were not associated with the PE. Repeated measurements of iron and TSAT predict risk of adverse outcomes in patients with post-ACS during 1 year follow-up. Trial Registration: The Netherlands Trial Register. Unique identifiers: NTR1698 and NTR1106. Registered at https://www.trialregister.nl/trial/1614 and https://www.trialregister.nl/trial/1073.

Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.

Am J Cardiol: 01 Apr 2022; 168:22-30
Gürgöze MT, Kardys I, Akkerhuis KM, Oemrawsingh RM, ... Manintveld OC, Boersma E
Am J Cardiol: 01 Apr 2022; 168:22-30 | PMID: 35045937
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Abstract

Early Resolution of New-Onset Left Bundle Branch Block After Transcatheter Aortic Valve Implantation With the SAPIEN 3 Valve.

Isogai T, Dykun I, Agrawal A, Shekhar S, ... Kapadia SR, Puri R
New-onset left bundle branch block (LBBB) is common after transcatheter aortic valve implantation (TAVI) but can resolve in the post-TAVI period. We sought to examine the incidence, predictors, and outcomes of early resolution of new-onset LBBB among TAVI recipients with a SAPIEN 3 (S3) valve. Among 1,203 S3-TAVI recipients without a pre-existing pacemaker or wide QRS complex at our institution between 2016 and 2019, we identified 143 patients who developed new-onset LBBB during TAVI and divided them according to the resolution or persistence of LBBB by the next day post-TAVI to compare high-degree atrioventricular block (HAVB) and permanent pacemaker (PPM) rates. Patients with resolved LBBB (n = 74, 52%), compared with those with persistent LBBB, were more often women and had a shorter QRS duration at baseline and post-TAVI, with a smaller S3 size and a shallower implantation depth. A multivariable logistic regression model demonstrated significant associations of post-TAVI QRS duration (per 10 ms increase, odds ratio = 0.60 [95% confidence interval = 0.44 to 0.82]) and implantation depth (per 1-mm-depth-increase, 0.77 [0.61 to 0.97]) with a lower likelihood of LBBB resolution. No patient with resolved LBBB developed HAVB within 30 days post-TAVI. Meanwhile, 8 patients (11.6%) with persistent LBBB developed HAVB. The 2-year PPM rate was significantly higher after persistent LBBB than after resolved LBBB (30.3% vs 4.5%, log-rank p <0.001), mainly driven by higher 30-day PPM rate (18.8% vs 0.0%). In conclusion, about half of new-onset LBBBs that occurred during S3-TAVI resolved by the next day post-TAVI without HAVB. In contrast, new-onset persistent LBBB may need follow-up with ambulatory monitoring within 30 days because of the HAVB risk.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am J Cardiol: 01 Apr 2022; 168:117-127
Isogai T, Dykun I, Agrawal A, Shekhar S, ... Kapadia SR, Puri R
Am J Cardiol: 01 Apr 2022; 168:117-127 | PMID: 35045936
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Abstract

Effect of Elevated C-Reactive Protein on Outcomes After Complex Percutaneous Coronary Intervention for Angina Pectoris.

Camaj A, Giustino G, Kocovic N, Cao D, ... Sharma SK, Mehran R
Inflammation and procedural complexity are individually associated with adverse outcomes after percutaneous coronary intervention (PCI). We aimed to evaluate the association of high sensitivity C-reactive protein (hsCRP) with adverse events according to PCI complexity. We included patients with available hsCRP levels who underwent PCI at our center from 2012 to 2017. We compared patients with hsCRP ≥3 versus <3 mg/L. Complex PCI was defined as having ≥1 of the following: ≥3 different target vessels, ≥3 lesions treated, ≥3 stents implanted, bifurcation lesion treated with 2 stents, chronic total occlusion as target lesion, or total stent length >60 mm. The primary end point was major adverse cardiac events (MACEs) (composite of all-cause death, myocardial infarction, or target vessel revascularization) at 1 year. A total of 11,979 patients were included, of which 2,840 (24%) underwent complex PCI. In those, 767 (27%) had hsCRP ≥3 mg/L. The 1-year incidence of MACE was 6% (noncomplex PCI, low hsCRP), 10% (noncomplex PCI, high hsCRP), 10% (complex PCI, low hsCRP), and 15% (complex PCI, high hsCRP). Overall, hsCRP ≥3 mg/L was associated with an increased risk of MACE compared with hsCRP <3 mg/L; this was independent of the number of complex PCI features: 0 (adjusted hazard ratio [HR] 1.53; 95% confidence interval [CI] 1.27 to 1.86), 1 (adjusted HR 1.77; 95% CI 1.21 to 2.60), or ≥2 (adjusted HR 1.21; 95% CI 0.80 to 1.83) (pinteraction = 0.42). In conclusion, in patients who underwent PCI, elevated hsCRP is associated with an increased risk of ischemic events. The effect of elevated hsCRP on cardiovascular risk is consistent regardless of PCI complexity.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am J Cardiol: 01 Apr 2022; 168:47-54
Camaj A, Giustino G, Kocovic N, Cao D, ... Sharma SK, Mehran R
Am J Cardiol: 01 Apr 2022; 168:47-54 | PMID: 35058052
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Abstract

Association between DBP and major adverse cardiovascular events in patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention.

Liu YH, Dai YN, Wang LT, Chen PY, ... Tan N, He PC
Background
In patients with stable coronary artery disease, low DBP is associated with an increased risk of myocardial infarction and cardiovascular death, but its association with clinical outcomes in patients with acute myocardial infarction undergoing percutaneous coronary intervention (PCI) is unknown.
Methods
Consecutive patients with ST-segment elevation myocardial infarction (STEMI) undergoing PCI from January 2010 to June 2016 were enrolled. The patients were divided into five groups according to the quintiles of DBP at admission. The primary outcome was in-hospital major adverse cardiovascular events (MACE) including all-cause death, stroke, target vessel revascularization, and recurrent myocardial infarction.
Results
A total of 2198 patients were enrolled, of whom 157 (7.1%) developed in-hospital MACE. Patients with DBP lower than 60 mmHg was associated with a higher rate of in-hospital MACE (14.8, 7.8, 5.6, 6.1, and 3.8%, P < 0.001) and all-cause death (12.5, 6.4, 4.3, 3.9, and 1.9%, P < 0.001) compared with those with DBP 60-69, 70-79, 80-89, and at least 90 mmHg. Multivariate logistic regression analysis demonstrated that DBP higher than 90 mmHg was a significant predictor of lower risk of in-hospital MACE (OR = 0.16, 95% CI = 0.04-0.61, P = 0.007). Cubic spline models for the association between DBP and MACE did not demonstrate a U-type relationship after adjusting for potential risk factors. During the follow-up, lower DBP was associated with a higher risk of all-cause death (P < 0.0001).
Conclusion
Lower DBP is independently associated with an elevated risk of in-hospital MACE and follow-up all-cause death.

Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.

J Hypertens: 31 Mar 2022; 40:692-698
Liu YH, Dai YN, Wang LT, Chen PY, ... Tan N, He PC
J Hypertens: 31 Mar 2022; 40:692-698 | PMID: 34889864
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Abstract

Single center experience in the treatment of hemodynamically significant diffuse coronary artery disease of the left anterior descending.

van Beek KAJ, van Steenbergen GJ, Vervaat FE, Mulders BCJH, ... van Nunen LX, Wijnbergen IF
Introduction
To date there are no recommendations on how to treat patients with an FFR positive but diffusely diseased left anterior descending coronary artery (LAD). Benefit of coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) is not so evident due to doubts regarding longevity and patency.
Methods
This retrospective single-center study assessed clinical outcomes in patients presenting with symptomatic single vessel coronary artery disease of a diffusely diseased, hemodynamically significant LAD treated by coronary artery bypass grafting (CABG) or optimal medical therapy (OMT) between 2015 and 2020. Primary outcome of this study was the composite endpoint of all-cause mortality, myocardial infarction and repeat revascularization during 2-year follow-up. Secondary endpoints consisted of the individual components of the primary endpoint. Change in angina severity grade based on the Canadian Cardiovascular Society (CCS) class between baseline and 2-year follow-up was assessed.
Results
Fifty-nine patients were included of which 25 patients underwent CABG and 34 patients were treated by OMT. There was a statistically significant difference in FFR value at baseline between the treatment groups (CABG 0.70 ± 0.04; OMT 0.75 ± 0.04; p < 0.001). After 2-year follow-up, there were no statistically significant differences with regard to the primary endpoint (CABG 16% (n = 4); OMT 17.6% (n = 6); p = 1.00) and secondary endpoints between the groups over 2-year follow-up.
Conclusion
In patients with hemodynamically significant diffuse single vessel coronary artery disease of the left anterior descending, there was no difference between OMT and CABG in terms of mortality, myocardial infarction, revascularization and symptom reduction after two years of follow-up.

Copyright © 2022 Elsevier B.V. All rights reserved.

Int J Cardiol: 31 Mar 2022; 352:40-44
van Beek KAJ, van Steenbergen GJ, Vervaat FE, Mulders BCJH, ... van Nunen LX, Wijnbergen IF
Int J Cardiol: 31 Mar 2022; 352:40-44 | PMID: 35090982
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Impact:
Abstract

Physiological and angiographic outcomes of PCI in calcified lesions after rotational atherectomy or intravascular lithotripsy.

Gallinoro E, Monizzi G, Sonck J, Candreva A, ... De Bruyne B, Collet C
Background
Percutaneous coronary interventions (PCI) in calcified coronary artery lesions are associated with impaired stent expansion, higher rate of periprocedural complications and cardiac mortality. Lesion preparation using calcium modifying techniques such as Rotational Atherectomy (RA) or Intravascular Lithotripsy (IVL) has been advocated. Studies comparing these technologies are lacking. We aimed to compare in-stent pressure gradients, evaluated by vessel fractional flow reserve (vFFR), in calcific lesions treated using either RA or IVL.
Methods
Patients undergoing either RA- or IVL-assisted PCI from two European centers were included. Propensity score matching (1:2) was performed to control for potential bias. Primary outcome was post-PCI in-stent pressure gradients calculated by vFFR (vFFRgrad). Secondary outcomes included the proportion of patients with complete functional revascularization defined as distal vFFR post-PCI (vFFRpost) ≥ 0.90.
Results
From a cohort of 210 patients, 105 matched patients (70 RA and 35 IVL) were included. Pre-PCI vFFR did not differ between groups (0.65 ± 0.13 RA and 0.67 ± 0.11 IVL). After PCI, in-stent pressure gradients were significantly lower in the IVL group (0.032 ± 0.026 vs 0.043 ± 0.026 in the RA group, p = 0.024). The proportions of vessels with functional complete revascularization was similar between the two groups (32.9% vs. 37.1% in the RA and IVL group, respectively; p = 0.669).
Conclusions
Calcific lesions preparation with IVL is effective and resulted in lower in-stent pressure gradients compared to RA. Approximately one third of the patients undergoing PCI for a severely calcified lesion achieved functional revascularization with no difference between rotational RA and IVL.

Copyright © 2022. Published by Elsevier B.V.

Int J Cardiol: 31 Mar 2022; 352:27-32
Gallinoro E, Monizzi G, Sonck J, Candreva A, ... De Bruyne B, Collet C
Int J Cardiol: 31 Mar 2022; 352:27-32 | PMID: 35120947
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Impact:
Abstract

Incidence, clinical impact and predictors of thrombocytopenia after transcatheter aortic valve replacement.

Tirado-Conte G, Salazar CH, McInerney A, Cruz-Utrilla A, ... Macaya C, Nombela-Franco L
Background
Thrombocytopenia is a common, yet poorly understood, complication after transcatheter aortic valve replacement (TAVR). Balloon-expandable transcatheter heart valve has been associated with higher incidence of thrombocytopenia, compared with self-expandable valves. The aim of this study was to analyze the incidence, clinical impact and predictors of acquired thrombocytopenia in patients undergoing TAVR.
Methods
We performed an observational study from consecutive patients with severe aortic stenosis undergoing TAVR (n = 679) in a single center. Association and best cut-off point of platelet decrease with early mortality was analyzed. Patients were classified according to postprocedural percentage decrease in platelet count (PDPC), comparing clinical outcomes and analyzing predictors of platelet decrease.
Results
The median PDPC was 37.1 [IQR: 27.4-46.9]. PDPC was associated with early mortality (OR: 2.1, 95%IC: 1.7-2.5 for each 10% decrease, AUC:0.81, 95%CI:0.72-0.89) with an optimal cut-off point of 46%. PDPC≥46% and late nadir (≥4 days) were both independent predictors of early mortality (OR: 6.0 [IQR: 2.4-14.9] and OR: 5.1 [IQR: 2.2-11.6], respectively). The combination of both factors (PDPC≥46% and nadir ≥4 day) was associated with higher 2-year mortality (55.7%) compared to an early significant nadir (PDPC≥46% and nadir <4 day, 28.9%) and non-significant nadir (PDPC<46%, 21.0%), p < 0.001. Independent predictors of PDPC≥46% were baseline platelet count, Portico™, Abbott valve, intraprocedural major vascular complication and residual aortic regurgitation ≥grade 2.
Conclusion
The platelet count decreased almost 40% after TAVR. Late nadir and PDPC≥46% predicted short-term clinical outcomes. Concomitant late and significant platelet decrease was associated with mid-term mortality.

Copyright © 2022 Elsevier B.V. All rights reserved.

Int J Cardiol: 31 Mar 2022; 352:21-26
Tirado-Conte G, Salazar CH, McInerney A, Cruz-Utrilla A, ... Macaya C, Nombela-Franco L
Int J Cardiol: 31 Mar 2022; 352:21-26 | PMID: 35124106
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Impact:
Abstract

Image-based biomechanical modeling for coronary atherosclerotic plaque progression and vulnerability prediction.

Lv R, Wang L, Maehara A, Guo X, ... Stone GW, Tang D
Atherosclerotic plaque progression and rupture play an important role in cardiovascular disease development and the final drastic events such as heart attack and stroke. Medical imaging and image-based computational modeling methods advanced considerably in recent years to quantify plaque morphology and biomechanical conditions and gain a better understanding of plaque evolution and rupture process. This article first briefly reviewed clinical imaging techniques for coronary thin-cap fibroatheroma (TCFA) plaques used in image-based computational modeling. This was followed by a summary of different types of biomechanical models for coronary plaques. Plaque progression and vulnerability prediction studies based on image-based computational modeling were reviewed and compared. Much progress has been made and a reasonable high prediction accuracy has been achieved. However, there are still some inconsistencies in existing literature on the impact of biomechanical and morphological factors on future plaque behavior, and it is very difficult to perform direct comparison analysis as differences like image modality, biomechanical factors selection, predictive models, and progression/vulnerability measures exist among these studies. Encouraging data and model sharing across the research community would partially resolve these differences, and possibly lead to clearer assertive conclusions. In vivo image-based computational modeling could be used as a powerful tool for quantitative assessment of coronary plaque vulnerability for potential clinical applications.

Copyright © 2022 The Author(s). Published by Elsevier B.V. All rights reserved.

Int J Cardiol: 31 Mar 2022; 352:1-8
Lv R, Wang L, Maehara A, Guo X, ... Stone GW, Tang D
Int J Cardiol: 31 Mar 2022; 352:1-8 | PMID: 35149139
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Impact:
Abstract

Early invasive versus non-invasive assessment in patients with suspected non-ST-elevation acute coronary syndrome.

Kite TA, Ladwiniec A, Arnold JR, McCann GP, Moss AJ
Non-ST-elevation acute coronary syndrome (NSTE-ACS) comprises a broad spectrum of disease ranging from unstable angina to myocardial infarction. International guidelines recommend a routine invasive strategy for managing patients with NSTE-ACS at high to very high-risk, supported by evidence of improved composite ischaemic outcomes as compared with a selective invasive strategy. However, accurate diagnosis of NSTE-ACS in the acute setting is challenging due to the spectrum of non-coronary disease that can manifest with similar symptoms. Heterogeneous clinical presentations and limited uptake of risk prediction tools can confound physician decision-making regarding the use and timing of invasive coronary angiography (ICA). Large proportions of patients with suspected NSTE-ACS do not require revascularisation but may unnecessarily undergo ICA with its attendant risks and associated costs. Advances in coronary CT angiography and cardiac MRI have prompted evaluation of whether non-invasive strategies may improve patient selection, or whether tailored approaches are better suited to specific subgroups. Future directions include (1) better understanding of risk stratification as a guide to investigation and therapy in suspected NSTE-ACS, (2) randomised clinical trials of non-invasive imaging versus standard of care approaches prior to ICA and (3) defining the optimal timing of very early ICA in high-risk NSTE-ACS.

© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.

Heart: 30 Mar 2022; 108:500-506
Kite TA, Ladwiniec A, Arnold JR, McCann GP, Moss AJ
Heart: 30 Mar 2022; 108:500-506 | PMID: 34234006
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Impact:
Abstract

Coronary revascularisation outcomes in patients with cancer.

Leedy D, Tiwana JK, Mamas M, Hira R, Cheng R
Cancer and coronary artery disease (CAD) overlap in traditional risk factors as well as molecular mechanisms underpinning the development of these two disease states. Patients with cancer are at increased risk of developing CAD, representing a high-risk population that are increasingly undergoing coronary revascularisation. Over 1 in 10 patients with CAD that require revascularisation with either percutaneous coronary intervention or coronary artery bypass grafting have either a history of cancer or active cancer. These patients are typically older, have more comorbidities and have more extensive CAD compared with patients without cancer. Haematological abnormalities with competing risks of thrombosis and bleeding pose further unique challenges during and after revascularisation. Management of patients with concurrent cancer and CAD requiring revascularisation is challenging as these patients carry a higher risk of morbidity and mortality compared with those without cancer, often driven by the underlying cancer and associated comorbidities. However, due to variability by different types and stages of cancer, revascularisation outcomes are specific to cancer characteristics such as the timing of onset, cancer subtype and site, stage, presence of metastases, and cancer-related therapies received. Recent studies have provided insights into defining revascularisation outcomes, procedural considerations and best practices in managing patients with cancer. Nevertheless, many gaps remain that require further studies to inform clinical best practices in this population.

© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.

Heart: 30 Mar 2022; 108:507-516
Leedy D, Tiwana JK, Mamas M, Hira R, Cheng R
Heart: 30 Mar 2022; 108:507-516 | PMID: 34415850
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Impact:
Abstract

Challenges of long-term dual antiplatelet therapy use following acute coronary syndromes.

Sidhu MS, Lyubarova R, Bangalore S, Bonaca MP
An acute coronary syndrome (ACS) event is associated with a high risk of recurrent ACS, stroke, and death. To ameliorate the risk of subsequent events, current guidelines for ST-segment elevation myocardial infarction and non-ST-segment elevation ACS recommend long-term management strategies for secondary prevention including risk factor modification and anti-ischemic and antiplatelet therapies. Dual antiplatelet therapy (DAPT), comprising aspirin plus a P2Y12 inhibitor, is a critical component of secondary prevention therapy following ACS. However, despite the importance of DAPT for secondary prevention after ACS, questions remain over the optimal duration of therapy. Clinical evidence is emerging that maintenance DAPT >12 months lowers the risk of recurrent ACS events; however, this benefit must be considered against any potential risks of prolonged DAPT such as bleeding. Several tools for bleeding risk assessment have shown promise; however, their limited accuracy and discriminative power necessitates further development. Assessment of patient ischemic risk should consider the complexity of the percutaneous coronary intervention (PCI) procedure, anatomic burden of coronary artery disease, and additional underlying risk factors. Consequently, identifying patients in whom the risk:benefit ratio favors prolonged DAPT may prove invaluable for clinicians in deciding which patients should continue or stop taking DAPT at 12 months after PCI, or consider P2Y12 inhibitor monotherapy as an option. This article reviews the most recent information about the risks and benefits of DAPT continued for >12 months after ACS and provides critical guidance to assist physicians in identifying patients most likely to benefit from a secondary prevention strategy with DAPT.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am Heart J: 30 Mar 2022; 246:44-64
Sidhu MS, Lyubarova R, Bangalore S, Bonaca MP
Am Heart J: 30 Mar 2022; 246:44-64 | PMID: 34933000
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Impact:
Abstract

Rationale and design of a randomized trial evaluating an external support device for saphenous vein coronary grafts.

Bagiella E, Puskas JD, Moskowitz AJ, Gelijns AC, ... Mack MJ, Goldstein DJ
Background
Coronary artery bypass grafting (CABG) is the most common revascularization approach for the treatment of multi-vessel coronary artery disease. While the internal mammary artery is nearly universally used to bypass the left anterior descending coronary artery, autologous saphenous vein grafts (SVGs) are still the most frequently used conduits to grafts the remaining coronary artery targets. Long-term failure of these grafts, however, continues to limit the benefits of surgery.
Methods
The Cardiothoracic Surgical Trials Network trial of the safety and effectiveness of a Venous External Support (VEST) device is a randomized, multicenter, within-patient trial comparing VEST-supported versus unsupported saphenous vein grafts in patients undergoing CABG. Key inclusion criteria are the need for CABG with a planned internal mammary artery to the left anterior descending and two or more saphenous vein grafts to other coronary arteries. The primary efficacy endpoint of the trial is SVG intimal hyperplasia (plaque + media) area assessed by intravascular ultrasound at 12 months post randomization. Occluded grafts are accounted for in the analysis of the primary endpoint. Secondary confirmatory endpoints are lumen diameter uniformity and graft failure (>50% stenosis) assessed by coronary angiography at 12 months. The safety endpoints are the occurrence of major adverse cardiac and cerebrovascular events and hospitalization within 5 years from randomization.
Conclusions
The results of the VEST trial will determine whether the VEST device can safely limit SVG intimal hyperplasia in patients undergoing CABG as treatment for coronary atherosclerotic disease.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am Heart J: 30 Mar 2022; 246:12-20
Bagiella E, Puskas JD, Moskowitz AJ, Gelijns AC, ... Mack MJ, Goldstein DJ
Am Heart J: 30 Mar 2022; 246:12-20 | PMID: 34936861
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Impact:
Abstract

Association between race/ethnicity and income on the likelihood of coronary revascularization among postmenopausal women with acute myocardial infarction: Women\'s health initiative study.

Tertulien T, Roberts MB, Eaton CB, Cene CW, ... Nassir R, Breathett K
Background
Historically, race, income, and gender were associated with likelihood of receipt of coronary revascularization for acute myocardial infarction (AMI). Given public health initiatives such as Healthy People 2010, it is unclear whether race and income remain associated with the likelihood of coronary revascularization among women with AMI.
Methods
Using the Women\'s Health Initiative Study, hazards ratio (HR) of revascularization for AMI was compared for Black and Hispanic women vs White women and among women with annual income <$20,000/year vs ≥$20,000/year over median 9.5 years follow-up(1993-2019). Proportional hazards models were adjusted for demographics, comorbidities, and AMI type. Results were stratified by revascularization type: percutaneous coronary intervention and coronary artery bypass grafting(CABG). Trends by race and income were compared pre- and post-2010 using time-varying analysis.
Results
Among 5,284 individuals with AMI (9.5% Black, 2.8% Hispanic, and 87.7% White; 23.2% <$20,000/year), Black race was associated with lower likelihood of receiving revascularization for AMI compared to White race in fully adjusted analyses [HR:0.79(95% Confidence Interval:[CI]0.66,0.95)]. When further stratified by type of revascularization, Black race was associated with lower likelihood of percutaneous coronary intervention for AMI compared to White race [HR:0.72(95% CI:0.59,0.90)] but not for CABG [HR:0.97(95%CI:0.72,1.32)]. Income was associated with lower likelihood of revascularization [HR:0.90(95%CI:0.82,0.99)] for AMI. No differences were observed for other racial/ethnic groups. Time periods (pre/post-2010) were not associated with change in revascularization rates.
Conclusion
Black race and income remain associated with lower likelihood of revascularization among patients presenting with AMI. There is a substantial need to disrupt the mechanisms contributing to race, sex, and income disparities in AMI management.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am Heart J: 30 Mar 2022; 246:82-92
Tertulien T, Roberts MB, Eaton CB, Cene CW, ... Nassir R, Breathett K
Am Heart J: 30 Mar 2022; 246:82-92 | PMID: 34998968
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Impact:
Abstract

Same day discharge following non-elective PCI for non-ST elevation acute coronary syndromes.

Hariri E, Kassas I, Hammoud MA, Hansra B, ... Smith CS, Barringhaus KG
Background:
and aim
Timing of discharge after percutaneous coronary intervention (PCI) is a crucial aspect of procedural safety and patient turnover. We examined predictors and outcomes of same-day discharge (SDD) after non-elective PCI for non-ST elevation acute coronary syndromes (NSTE-ACS) in comparison with next-day discharge (NDD).
Methods
Baseline demographic, clinical, and procedural data were collected as were in-hospital outcomes and post-PCI length of stay (LOS) for all patients undergoing non-elective PCI for NSTE-ACS between 2011 and 2014 at a central tertiary care center. Thirty day and 1-year mortality and bleeding as well as 30-day readmission rates were determined from social security record and medical chart review. Logistic regression was performed to identify predictors of SDD, and propensity-matched analysis was done to examine the differences in outcomes between NDD and SDD.
Results
Out of 2,529 patients who underwent non-elective PCI for NSTE-ACS from 2011 to 2014, 1,385 met the inclusion criteria (mean age = 63 years; 26% women) and were discharged either the same day of (N = 300) or the day after (N = 1,085) PCI. Thirty-day and one-year mortality and major bleeding rates were similar between the 2 groups. Logistic regression identified male sex, radial access, negative troponin biomarker status, and procedure start time as predictors of SDD. In propensity-matched analyses, there was no difference in 30-day mortality and readmission between SDD and NDD groups.
Conclusions
SDD after non-elective PCI for NSTE-ACS may be a reasonable alternative to NDD for selected low-risk patients with comparable mortality, bleeding, and readmission rates.

Copyright © 2022 Elsevier Inc. All rights reserved.

Am Heart J: 30 Mar 2022; 246:125-135
Hariri E, Kassas I, Hammoud MA, Hansra B, ... Smith CS, Barringhaus KG
Am Heart J: 30 Mar 2022; 246:125-135 | PMID: 34998967
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Impact:
Abstract

One-year outcome after percutaneous coronary intervention in nonagenarians: Insights from the J-PCI OUTCOME registry.

Otowa K, Kohsaka S, Sawano M, Matsuura S, ... Nakamura M, Ikari Y
Background
Nonagenarian patients who undergo percutaneous coronary intervention (PCI) are increasing, and a few previous studies have reported their long-term outcomes. However, differences in their long-term outcomes between generations remain unclear. This study aimed to investigate 1-year all-cause and cardiovascular (CV) mortality, and major adverse cardiovascular events (MACE; cardiovascular death, myocardial infarction, and stroke) of nonagenarian patients who underwent PCI compared with the other elder patients, using a nationwide registration system.
Methods
The patient-level data registered between January 2017 and December 2017 was extracted from the J-PCI OUTCOME Registry endorsed by the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT). The one-year all-cause and cardiovascular (CV) mortality, MACE, and major bleeding events were identified.
Results
Out of 40,722 patients over 60 years of age, 880 (2.1%) were nonagenarians. For nonagenarians, the 1-year mortality rate was substantial (13.5%). The MACE and CV death rates were also high (8.1%, and 6.8%, respectively) for nonagenarians, and these event rates were approximately 1.5 times higher in nonagenarians than octogenarians. Multivariate regression analysis showed that presentation with cardiogenic shock [hazard ratio (HR) 2.32; 95 confidence intervals (CI): 1.22-4.41], or cardiac arrest (HR 2.91; 90% CI: 1.28-6.62), and use of oral anticoagulants (HR 2.10; 90% CI: 1.07-4.12) were the predictors of 1-year MACE.
Conclusions
Even in the contemporary era, nonagenarians who have undergone PCI still face a considerably increased risk for adverse cardiovascular events that reduces long-term survival. In addition to having poorer lesion characteristics, adverse events, including death, MACEs, and major bleeding, occurred 1.5 times more frequently in nonagenarians than in octogenarians.

Copyright © 2022 Elsevier Inc. All rights reserved.

Am Heart J: 30 Mar 2022; 246:105-116
Otowa K, Kohsaka S, Sawano M, Matsuura S, ... Nakamura M, Ikari Y
Am Heart J: 30 Mar 2022; 246:105-116 | PMID: 35016854
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Impact:
Abstract

How to set up regional STEMI networks: a \"Stent - Save a life!\" initiative.

Candiello A, Alexander T, Delport R, Toth GG, ... Baumbach A, Naber C
Clinical guidelines recommend the development of ST-elevation myocardial infarction (STEMI) networks at community, regional and/or national level to ideally offer primary coronary angioplasty, or at least the best available STEMI care to all patients. However, there is a discrepancy between this clinical recommendation and daily practice, with no coordinated care for STEMI patients in many regions of the world. While this can be a consequence of lack of resources, in reality it is more frequently a lack of organisational power. In this paper, the Stent - Save a Life! Initiative (www.stentsavealife.com) proposes a practical methodology to set up a STEMI network effectively in any region of the world with existing resources, and to develop the STEMI network continuously once it has been established.



EuroIntervention: 18 Mar 2022; 17:1313-1317
Candiello A, Alexander T, Delport R, Toth GG, ... Baumbach A, Naber C
EuroIntervention: 18 Mar 2022; 17:1313-1317 | PMID: 34387547
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Impact:
Abstract

Long-term clinical outcomes of everolimus-eluting bioresorbable scaffolds versus everolimus-eluting stents: final five-year results of the AIDA randomised clinical trial.

Kerkmeijer LSM, Renkens MPL, Tijssen RYG, Hofma SH, ... de Winter RJ, Wykrzykowska JJ
Background
Absorb bioresorbable vascular scaffold (BVS)-related events have been reported between 1 and 3 years - the period of active scaffold bioresorption. Data on the performance of the Absorb BVS in daily clinical practice beyond this time point are scarce.
Aims
This report aimed to provide the final five-year clinical follow-up of the Absorb BVS in comparison with the XIENCE everolimus-eluting stent (EES). In addition, we evaluated the effect of prolonged dual antiplatelet therapy (DAPT) administration on events in the scaffold group.
Methods
AIDA was a multicentre, investigator-initiated, non-inferiority trial, in which 1,845 unselected patients with coronary artery disease were randomly assigned to either the Absorb BVS (n=924) or the XIENCE EES (n=921). Target vessel failure (TVF), a composite of cardiac death, target vessel myocardial infarction or target vessel revascularisation, was the primary endpoint. Scaffold thrombosis cases were matched with controls and tested for the effect of prolonged DAPT.
Results
Up to five-year follow-up, there was no difference in TVF between the Absorb BVS (17.7%) and the XIENCE EES (16.1%) (hazard ratio [HR] 1.31, 95% confidence interval [CI]: 0.90-1.41; p=0.302). Definite or probable device thrombosis (DT) occurred in 43 patients (4.8%) in the scaffold group compared to 13 patients (1.5%) in the stent group (HR 3.32, 95% CI: 1.78-6.17; p<0.001). DT between 3 and 4 years occurred six times in the Absorb arm versus three times in the XIENCE arm. Between 4 and 5 years, the incidence was three versus two, respectively. Of those three DT in the scaffold group, two occurred in XIENCE EES-treated lesions. The odds ratio of scaffold thrombosis in patients on DAPT compared to off DAPT throughout five-year follow-up was 0.36 (95% CI: 0.15-0.86).
Conclusions
The excess risk of the Absorb BVS on late adverse events, in particular device thrombosis, in routine PCI continues up to 4 years and seems to plateau afterwards. Clinical
Trial registration:
ClinicalTrials.gov: NCT01858077.



EuroIntervention: 18 Mar 2022; 17:1340-1347
Kerkmeijer LSM, Renkens MPL, Tijssen RYG, Hofma SH, ... de Winter RJ, Wykrzykowska JJ
EuroIntervention: 18 Mar 2022; 17:1340-1347 | PMID: 34483094
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Impact:
Abstract

Transcatheter edge-to-edge mitral valve repair in patients with mitral annulus calcification.

Fernández-Peregrina E, Pascual I, Freixa X, Tirado-Conte G, ... Nombela-Franco L, Arzamendi D
Background
MAC is commonly found in patients affected with MR, and it is associated with high morbidity, mortality and worse cardiac surgical outcomes. Transcatheter edge-to-edge repair could be an alternative treatment, although there is little evidence in this population.
Aims
The aim of this study was to analyse the safety, efficacy and durability of MitraClip implantation in patients affected with mitral regurgitation (MR) and mitral annulus calcification (MAC).
Methods
We analysed the outcomes of 61 suitable patients affected with severe MR and moderate or severe MAC (the \"MAC\" group) and 791 patients with no or mild MAC (the \"NoMAC\" group) treated with the MitraClip device.
Results
Procedural success was similar (91.8% vs 95.1%, p=0.268, in MAC and NoMAC, respectively), with a very low rate of complications. At one-year follow-up, 90.6% of MAC and 79.5% of NoMAC patients had MR grade ≤2 (p=0.129), 80% in both groups remained in NYHA Functional Class ≤II, and a significant reduction in cardiac readmissions was observed (65% vs 78% in MAC vs NoMAC, p=0.145). One-year mortality tended to be higher in MAC patients (19.7% vs 11.3%, p=0.050), with no difference in cardiovascular mortality (15.3% vs 9.2%, p=0.129).
Conclusions
MitraClip use in selected patients with moderate or severe MAC is safe, feasible and achieves good clinical and echocardiographic results at one-year follow-up.



EuroIntervention: 18 Mar 2022; 17:1300-1309
Fernández-Peregrina E, Pascual I, Freixa X, Tirado-Conte G, ... Nombela-Franco L, Arzamendi D
EuroIntervention: 18 Mar 2022; 17:1300-1309 | PMID: 34483091
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Impact:
Abstract

Prevalence, predictors, and outcomes of in-stent restenosis with calcified nodules.

Tada T, Miura K, Ikuta A, Ohya M, ... Fuku Y, Kadota K
Background
Calcified nodules (CN) have been reported as being associated with stent failure including in-stent restenosis (ISR). However, there is no systematic study of this condition.
Aims
We aimed to clarify the prevalence, predictors, and midterm results of ISR lesions with CN.
Methods
We examined the clinical characteristics of 651 ISR lesions in patients who underwent percutaneous coronary intervention (PCI) with optical coherence tomography (OCT) between October 2008 and July 2016, and their 6- to 8-month follow-up angiography results. CN was defined as a high backscattering mass with small nodular calcium depositions which protruded into the vessel lumen.
Results
Thirty-two ISR lesions (4.9%) had CN. Multivariable analysis showed that calcified lesion (odds ratio [OR] 12.441, p<0.001), incomplete stent apposition (OR 3.228, p=0.005), haemodialysis (OR 3.633, p=0.024), and female gender (OR 3.212, p=0.036) were independently associated with ISR lesions with CN. Midterm follow-up was performed on 612 ISR lesions. Both ISR and target lesion revascularisation (TLR) rates were significantly higher in lesions with CN compared with those without CN (43.8% vs 25.0%, p=0.023; 37.5% vs 18.8%, p=0.020, respectively). However, multivariate analysis did not show the presence of CN as an independent predictor of re-TLR (OR 1.690, p=0.286).
Conclusions
The prevalence of ISR lesions with CN was 4.9%. Calcified lesions, incomplete stent apposition, haemodialysis, and female gender are probably associated with CN formation. ISR lesions with CN may have poor midterm outcomes compared with ISR lesions without CN.



EuroIntervention: 18 Mar 2022; 17:1352-1361
Tada T, Miura K, Ikuta A, Ohya M, ... Fuku Y, Kadota K
EuroIntervention: 18 Mar 2022; 17:1352-1361 | PMID: 34483090
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Impact:
Abstract

Temporal trends in clinical outcomes after percutaneous coronary intervention: a systematic review of 66,327 patients from 25 all-comers trials.

Asano T, Ono M, Dai Z, Saito A, ... Yoneoka D, Komiyama N
Background
With the improvements of percutaneous coronary intervention (PCI) technology and post-PCI patient management, several registry studies reported temporal trends in post-PCI clinical outcomes. However, their results are inconclusive, potentially reflecting region-specific trends, based on site-reported events without external validity.
Aims
This study aimed to investigate temporal trends in post-PCI clinical outcomes in all-comers randomised controlled trials (RCTs) involving coronary stents.
Methods
We performed a systematic review identifying RCTs comparing a clinical outcome as a primary endpoint among different coronary stents with an all-comers design and independent clinical event adjudication, extracting the study start year, patient baseline characteristics, and one- and five-year clinical outcomes. Temporal trends in clinical outcomes (cardiac death, myocardial infarction [MI], target lesion revascularisation [TLR], stent thrombosis [ST]) were assessed using random-effects meta-regression analyses, estimating the relationship between clinical outcomes and study start year.
Results
Overall, 25 all-comers trials (51 device arms, 66,327 patients) conducted between 2003 and 2018 fulfilled the eligibility criteria. Random-effects meta-regression analysis revealed significant decreasing trends in one- and five-year cardiac death, one-year TLR, and five-year ST incidences (relative risk per 10-year increase: 0.69 [0.51-0.92], 0.66 [0.44-0.98], 0.60 [0.41-0.88], and 0.18 [0.07-0.44], respectively). There was no significant trend in myocardial infarction incidences.
Conclusions
This is the first attempt to clarify and quantify the temporal trends of post-PCI outcome incidence. The 15-year improvements in PCI therapy and post-therapeutic patient management are associated with reduced incidences of cardiac death and PCI-related adverse events.



EuroIntervention: 18 Mar 2022; 17:1318-1329
Asano T, Ono M, Dai Z, Saito A, ... Yoneoka D, Komiyama N
EuroIntervention: 18 Mar 2022; 17:1318-1329 | PMID: 34602385
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Abstract

Clinical outcomes of transcatheter aortic valve implantation in patients younger than 70 years rejected for surgery: the AMTRAC registry.

Witberg G, Landes U, Codner P, Barbanti M, ... Finkelstein A, Kornowski R
Background
The mean age of transcatheter aortic valve implantation (TAVI) patients is steadily decreasing.
Aims
The aim of the study was to describe the characteristics, the indications for and the outcomes of TAVI in patients <70 years old.
Methods
All patients undergoing TAVI (n=8,626) from the 18 participating centres between January 2007 and June 2020 were stratified by age (</>70). For patients <70, the indications for TAVI were extracted from Heart Team discussions and the baseline characteristics and mortality were compared between the two groups.
Results
Overall, 640 (7.4%) patients were <70 (9.1% during 2018-2020, p<0.001); the mean age was 65.0±2.3 years. The younger patients were more often male, with bicuspid valves or needing valve-in-valve procedures. They had a higher prevalence of lung disease and diabetes. In 80.7% of cases, the Heart Team estimated an increased surgical risk and TAVI was selected, reflected by an STS score >4% in 20.4%. Five-year mortality was similar (29.4 vs 29.8%, HR 0.95, p=0.432) in the <70 and >70 groups. In the <70 group, mortality was higher for those referred for TAVI due to an increased surgical risk compared to those referred for other reasons (31.6 vs 24.5%, HR 1.23, p=0.021). Mortality was similar regardless of the STS stratum in patients judged by the Heart Team to be at increased surgical risk (32.6 vs 30.4%, HR 0.98, p=0.715).
Conclusions
Use of TAVI in patients <70 is becoming more frequent. The main reason for choosing TAVI is due to an increased surgical risk not adequately represented by the STS score. The outcomes for these patients are similar to those for older TAVI patients. Dedicated trials of TAVI/SAVR in younger patients are needed to guide decisions concerning expansion of TAVI indications. ((ClinicalTrials.gov: NCT04031274).



EuroIntervention: 18 Mar 2022; 17:1289-1297
Witberg G, Landes U, Codner P, Barbanti M, ... Finkelstein A, Kornowski R
EuroIntervention: 18 Mar 2022; 17:1289-1297 | PMID: 34673502
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Abstract

Safety and efficacy of ticagrelor monotherapy according to drug-eluting stent type: the TWILIGHT-STENT study.

Dangas G, Baber U, Sharma S, Giustino G, ... Gibson CM, Mehran R
Background
In the TWILIGHT trial, ticagrelor monotherapy after a short course of dual antiplatelet therapy (DAPT) was shown to be a safe bleeding avoidance strategy in high-risk patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES).
Aims
The aim of this study was to evaluate the effects of ticagrelor monotherapy after three-month DAPT in patients undergoing PCI, according to DES type.
Methods
In the current sub-analysis from TWILIGHT, patients were stratified into three groups based on DES type: durable polymer everolimus-eluting stents (DP-EES), durable polymer zotarolimus-eluting stents (DP-ZES), and biodegradable polymer DES (BP-DES). Bleeding and ischaemic outcomes were assessed at one year after randomisation.
Results
Out of 5,769 patients, 3,014 (52.2%) had DP-EES, 1,350 (23.4%) had DP-ZES and 1,405 (24.4%) had BP-DES. Compared with ticagrelor plus aspirin, ticagrelor monotherapy had significantly lower BARC type 2, 3 or 5 bleeding compared with DAPT; DP-EES (3.8% vs 6.7%; HR 0.56, 95% CI: 0.41-0.78), DP-ZES (4.6% vs 6.9%; HR 0.66, 95% CI: 0.42-1.04) and BP-DES (4.2% vs 7.9%; HR 0.52, 95% CI: 0.33-0.81; pinteraction=0.76). Ticagrelor monotherapy resulted in similar rates of death, MI, or stroke: DP-EES (4.2% vs 4.3%; HR 0.97; 95% CI: 0.68-1.37); DP-ZES (4.1% vs 3.1%; HR 1.32; 95% CI: 0.75-2.33); BP-DES (3.9% vs 4.2%; HR 0.92; 95% CI: 0.54-1.55; pinteraction=0.60). In both unadjusted and covariate-adjusted analyses, DES type was not associated with any differences in ischaemic or bleeding complications.
Conclusions
As compared with ticagrelor plus aspirin, ticagrelor monotherapy after a short DAPT duration lowered bleeding complications without increasing the ischaemic risk, irrespective of DES type. We observed no significant differences among DES types.



EuroIntervention: 18 Mar 2022; 17:1330-1339
Dangas G, Baber U, Sharma S, Giustino G, ... Gibson CM, Mehran R
EuroIntervention: 18 Mar 2022; 17:1330-1339 | PMID: 34881696
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Abstract

A new fastening system for temporary pacing with active-fixation leads: effectiveness and safety.

Vicente-Miralles R, Martín-Langerwerf DA, Núñez-Martínez JM, Marco-Juan A, ... Gil-Guillén VF, Bertomeu-Gonzalez V
Aims
Temporary cardiac pacing with active-fixation leads (TPAFL) using a reusable permanent pacemaker generator has been shown to be safer than lead systems without fixation. However, TPAFL requires the off-label use of pacemaker leads and generators. We designed a fastening system to ensure the safety and efficacy of the procedure: the KronoSafe System®. To demonstrate the safety and effectiveness of the KronoSafe System® for temporary pacing in a series of patients receiving TPAFL.
Methods and results
A prospective cohort of 20 patients undergoing TPAFL between August 2019 and June 2020 was recruited in a Spanish region. The temporary pacemaker was implanted through jugular access and secured with the KronoSafe System®. R-wave detection, lead impedance, and capture threshold were assessed every 48 h. Complications associated with the procedure or occurring during TPAFL were recorded. There were no complications associated with temporary pacing, and the therapy was effective in all cases. TPAFL was used for a mean of 7.6 days (maximum 25 days), and 84.56% of the time in a cardiology ward.
Conclusion
TPAFL secured using the KronoSafe system® provides safe and stable cardiac stimulation for patients requiring temporary cardiac pacing.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.

Eur Heart J Acute Cardiovasc Care: 16 Mar 2022; 11:224-229
Vicente-Miralles R, Martín-Langerwerf DA, Núñez-Martínez JM, Marco-Juan A, ... Gil-Guillén VF, Bertomeu-Gonzalez V
Eur Heart J Acute Cardiovasc Care: 16 Mar 2022; 11:224-229 | PMID: 34918044
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Abstract

Clinical outcomes of no stenting in patients with ST-segment elevation myocardial infarction undergoing deferred primary percutaneous coronary intervention.

Madsen JM, Kelbæk H, Nepper-Christensen L, Jacobsen MR, ... Engstrøm T, Lønborg JT
Background
ST-segment elevation myocardial infarction (STEMI) is treated with stenting, but the underlying stenosis is often not severe, and stenting may potentially be omitted.
Aims
The aim of the study was to investigate outcomes of patients with STEMI treated with percutaneous coronary intervention (PCI) without stenting.
Methods
Patients were identified through the DANAMI-3-DEFER study. Stenting was omitted in the patients with stable flow after initial PCI and no significant residual stenosis on the deferral procedure, who were randomised to deferred stenting. These patients were compared to patients randomised to conventional PCI treated with immediate stenting. The primary endpoint was a composite of all-cause mortality, recurrent myocardial infarction (MI), and target vessel revascularisation (TVR).
Results
Of 603 patients randomised to deferred stenting, 84 were treated without stenting, and in patients randomised to conventional PCI (n=612), 590 were treated with immediate stenting. Patients treated with no stenting had a median stenosis of 40%, median vessel diameter of 2.9 mm, and median lesion length of 11.4 mm. During a median follow-up of 3.4 years, the composite endpoint occurred in 14% and 16% in the no and immediate stenting group, respectively (unadjusted hazard ratio [HR] 0.87, 95% confidence interval [CI]: 0.48-1.60; p=0.66). The association remained non-significant after adjusting for confounders (adjusted HR 0.53, 95% CI: 0.22-1.24; p=0.14). The rate of TVR and recurrent MI were 2% vs 4% (p=0.70) and 4% vs 6% (p=0.43), respectively.
Conclusions
Patients with STEMI, with no significant residual stenosis and stable flow after initial PCI, treated without stenting, had comparable event rates to patients treated with immediate stenting.



EuroIntervention: 15 Mar 2022; epub ahead of print
Madsen JM, Kelbæk H, Nepper-Christensen L, Jacobsen MR, ... Engstrøm T, Lønborg JT
EuroIntervention: 15 Mar 2022; epub ahead of print | PMID: 35289303
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Abstract

Association between obesity grade and the age of the first acute coronary syndrome: Prospective observational study.

Demirci D, Demirci DE, Chi G
Background
The study evaluates how obesity grade is associated with age during the first acute coronary syndrome (ACS) and examines the effect of cardiovascular (CV) risk factors and the age of first ACS in patients with severe obesity.
Methods
We enrolled consecutive patients diagnosed with first episode of ACS between 2014 and 2019, and categorized them by body mass indices (BMI). Severe obesity was defined as BMI ≥35 kg/m2. Independent variables affecting the age of first ACS were examined by linear regression analysis.
Results
A total of 1005 patients (mean age, 57.5 ± 12.3 years; 19.3% female) were included. Approximately 6% and 12% of obese patients and normal weight patients had no other risk factors. Patients with ACS with severe obesity were younger than those with ACS in the grade-I obesity, overweight, and normal-weight groups (52.8 ± 9.9 vs. 55.3 ± 10.9, 56.8 ± 11.4, and 61.4 ± 14.2, respectively, p < 0.001). BMI had a strong, inverse linear relationship with earlier age of first ACS. The number of patients with no risk factors was significantly high in normal-weight individuals compared with patients with severe obesity (11.6% vs 5.6%, p = 0.037). After adjusting for CV risk factors, patients with overweight, grade-I obesity, and severe obesity may experience first ACS sooner than those with normal-weight by 3.9, 6.1, and 7.7 years, respectively (p < 0.001). However, males and females with severe obesity without CV risk factors experienced the first ACS episode 16 and 22 years later than those with the highest number of risk factors, respectively.
Conclusion
Patients with severe obesity experience first ACS episode 7.7 years earlier than those with normal-weight. Absence of CV risk factors in people with obesity can improve the potential negative effect of obesity on the ACS age.
Trial registration
NCT04578964, 08 October 2020.

Copyright © 2021. Published by Elsevier B.V.

Int J Cardiol: 14 Mar 2022; 351:93-99
Demirci D, Demirci DE, Chi G
Int J Cardiol: 14 Mar 2022; 351:93-99 | PMID: 34864079
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Abstract

Optimal low-density lipoprotein cholesterol target level in Korean acute myocardial infarction patients (<70 mg/dL vs. <55 mg/dL): Based on Korea acute myocardial infarction registry-National Institute of Health.

Ahn JH, Ahn Y, Jeong MH, Kim JH, ... Hur SH, Oh SK
Background
Current treatment guidelines for acute myocardial infarction (AMI) recommend lowering low density lipoprotein cholesterol (LDL-C). However, previous clinical studies among East Asian AMI patients failed to prove its clinical efficacy of lipid lowering therapy based on Western target LDL-C level. Thus, the purpose of this study is directly to compare the clinical outcomes of target LDL-C < 70 mg/dL and < 55 mg/dL and identify optimal target LDL-C level and in Korean AMI patients.
Methods and results
A total of 2198 AMI patients in Korea AMI Registry - National Institute of Health were enrolled. Patients were initially divided into LDL-C non-target group (n = 1115) and target group (n = 1083). Successful achievement of follow up target LDL-C was defined as <70 mg/dL and ≥ 50% reduction from baseline. Target group patients were additionally divided to <70 mg/dL group (n = 698) and <55 mg/dL group (n = 385). Propensity score matching analysis was done in non-target vs. target group and <70 mg/dL vs. <55 mg/dL group. In the matched population, the risk of 3 years major adverse cardiac event (MACE) (13.0% vs 9.8%, HR: 0.73; 95% CI: 0.56-0.96; p = 0.025) was higher in non-target group patients. However, the risk of MACE was similar in <70 mg/dL and < 55 mg/dL group patients (10.0% vs 8.1%, HR: 0.75, 95% CI: 0.46-1.22; p = 0.247).
Conclusion
In the present study, target LDL-C level of <70 mg/dL and ≥ 50% reduction from baseline level was associated with better clinical outcomes in Korean AMI patients. However, further lowering target LDL-C level of <55 mg/dL showed no additional benefits.

Copyright © 2021 Elsevier B.V. All rights reserved.

Int J Cardiol: 14 Mar 2022; 351:15-22
Ahn JH, Ahn Y, Jeong MH, Kim JH, ... Hur SH, Oh SK
Int J Cardiol: 14 Mar 2022; 351:15-22 | PMID: 34921900
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Impact:
Abstract

Early angiography in elderly patients with non-ST-segment elevation acute coronary syndrome: The cardio CHUS-HUSJ registry.

González Ferrero T, Álvarez Álvarez B, Cordero A, Martinón Martínez J, ... Gude Sampedro F, González Juanatey JR
Background
In elderly patients with non-ST elevation acute coronary syndrome (NSTEACS), while routine invasive management is established in high-risk NSTEACS patients, there is still uncertainty regarding the optimal timing of the procedure.
Methods
This study analyzes the association of early coronary angiography with all-cause mortality, cardiovascular mortality, heart failure (HF) hospitalization, and major adverse cardiovascular events (MACE) in patients older than 75 years old with NSTEACS. This retrospective observational study included 7811 consecutive NSTEACS patients who were examined between the years 2003 and 2017 at two Spanish university hospitals. There were 2290 patients older than 75 years old. We compared their baseline characteristics according to the early invasive strategy used (coronarography ≤24 h vs. coronarography >24 h) after the diagnosis of NSTEACS.
Results
Among the study participants, 1566 patients (68.38%) underwent early invasive coronary intervention. The mean follow-up period was 46 months (interquartile range 18-71 months). This association was also maintained after propensity score matching: early invasive strategy was significantly related to lower all-cause mortality [HR 0.61 (95% CI 0.51-0.71)], cardiovascular mortality [HR 0.52 (95% CI 0.43-0.63)], and MACE [HR 0.62 (CI 95% 0.54-0.71)].
Concusions
In a contemporary real-world registry of elderly NSTEACS patients, early invasive management significantly reduced all-cause mortality, cardiovascular mortality, and MACE during long-term follow-up.
Brief summary
In this real-world retrospective observational study that included 2451 patients older than 75 years old, 1566 patients (68.38%) underwent early invasive coronary intervention. After performing a propensity score matching, the early invasive strategy was still associated with lower all-cause mortality [HR (hazard ratio) 0.61, 95% CI (95% confidence interval) (0.51-0.71)], cardiovascular mortality [HR 0.52 (95%CI 0.43-0.63)], and MACE [HR 0.62 (95%CI 0.54-0.71)] during long-term follow-up.

Copyright © 2021 Elsevier B.V. All rights reserved.

Int J Cardiol: 14 Mar 2022; 351:8-14
González Ferrero T, Álvarez Álvarez B, Cordero A, Martinón Martínez J, ... Gude Sampedro F, González Juanatey JR
Int J Cardiol: 14 Mar 2022; 351:8-14 | PMID: 34942303
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Abstract

Acute myocarditis revealing autoimmune and inflammatory disorders: Clinical presentation and outcome.

Chaligne C, Mageau A, Ducrocq G, Ou P, ... Papo T, Sacre K
Background
Acute myocarditis (AM) may be the heralding manifestation of autoimmune and inflammatory disorders (AIID). We aimed to describe the clinical presentation and outcome of patients with AM revealing AIID.
Methods
All consecutive adult patients with AM admitted in a department of Cardiology (Bichat Hospital, Paris, France) from January 2011 to January 2019 were included. Diagnosis of AM was based on clinical manifestations, elevated Troponin, myocardial inflammation on CMR and no evidence for coronary artery disease. AIID were classified using international criteria.
Results
Two-hundred and eighteen (35.3 [26.4-47.1] years, 75.2% males) patients with AM were included. Overall, AM revealed AIID in 15 (6.9%), including systemic lupus erythematosus (n = 3), adult onset Still\'s disease (n = 3), sarcoidosis (n = 2), mixed connective tissue disease (n = 1), anti-Jo1 syndrome (n = 1), eosinophilic granulomatosis with polyangiitis (n = 1), antiphospholipid syndrome (n = 1), reactive arthritis (n = 1), Graves\' disease (n = 1) and Crohn\'s colitis (n = 1). Left ventricular ejection fraction (LVEF) at onset was <30% in 5 (33.3%) patients with AIID. All but 2 patients with AIID were treated with steroids, immunosuppressive and/or immunomodulatory drugs and LVEF normalized in all by the end of follow-up. By comparing patients with AIID to patients with idiopathic AM (n = 203), multivariable analysis showed that pericardial effusion, lack of chest pain and high CRP level at onset were independently associated with AIID.
Conclusion
Acute myocarditis revealing AIID may be life-threatening at the acute phase but has an overall good prognosis under specific treatment. Pericardial effusion and CRP level at admission suggest an AIID as the cause for AM.

Copyright © 2021 Elsevier B.V. All rights reserved.

Int J Cardiol: 14 Mar 2022; 351:84-88
Chaligne C, Mageau A, Ducrocq G, Ou P, ... Papo T, Sacre K
Int J Cardiol: 14 Mar 2022; 351:84-88 | PMID: 34979146
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Impact:
Abstract

Incidence, Risk Factors, and Prognosis of Cholesterol Crystal Embolism Because of Percutaneous Coronary Intervention.

Takahashi K, Omuro A, Ohya M, Kubo S, ... Fuku Y, Kadota K
Cholesterol crystal embolism (CCE) is a rare but serious complication of percutaneous coronary intervention (PCI). However, its incidence, risk factors, and prognosis in the contemporary era are not well known. We included 23,184 patients who underwent PCI in our institution between January 2000 and December 2019 in this study. The diagnosis of CCE was made histologically or by the combination of cutaneous signs and specific blood test results. In patients with CCE, we evaluated the incidence, risk factors, and prognosis. A total of 88 patients (0.38%) were diagnosed with CCE. The incidence of CCE seemed to decline through the investigated 20 years. Positive predictors of CCE were age ≥70 years (68% vs 59%, p = 0.012), aortic aneurysm (23% vs 7.2% p <0.001), and a femoral approach (71% vs 45%, p <0.001), whereas a negative predictor of CCE was the use of an inner sheath (63% vs 77%, p <0.001). The rate of 1-year mortality and the requirement for chronic hemodialysis within 1 year after PCI in patients with CCE were 10% and 11%, respectively. The use of an inner sheath and a nonfemoral approach was associated with a lower incidence of CCE. In conclusion, because the prognosis of patients with CCE is still poor, preprocedural identification of high-risk patients and selection of low-risk procedures could be important for preventing CCE.

Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.

Am J Cardiol: 14 Mar 2022; 167:15-19
Takahashi K, Omuro A, Ohya M, Kubo S, ... Fuku Y, Kadota K
Am J Cardiol: 14 Mar 2022; 167:15-19 | PMID: 34986990
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Impact:
Abstract

Incidence, Clinical Characteristics and Short-Term Prognosis in Patients With Cardiogenic Shock and Various Left Ventricular Ejection Fractions After Acute Myocardial Infarction.

Jiang Y, Boris AF, Zhu Y, Gan H, ... Luo S, Huang B
The 2016 European Society of Cardiology Guidelines introduced a new term, mid-range left ventricular ejection fraction (mrEF) heart failure, however, the clinical characteristics and short-term outcomes in cardiogenic shock patients with mrEF after acute myocardial infarction remain unclear. This retrospective study analyzed the baseline characteristics, management, and outcomes according to the left ventricular ejection fraction (LVEF), reduced LVEF (rEF) ≤40%, mrEF 41% to 49%, and preserved LVEF (pEF) ≥50% in patients with acute myocardial infarction complicated by cardiogenic shock. The primary end point was 30-day all-cause mortality and the secondary end point was the composite events of major adverse cardiovascular events (MACEs). In 218 patients, 71 (32.6%) were patients with mrEF. Compared with those with pEF, patients with mrEF had some similar clinical characteristics to that of rEF. The 30-day all-cause mortality in patients with rEF, mrEF, and pEF were 72.7%, 56.3%, and 32.0%, respectively (p = 0.001). The 30-day MACE were 90.9%, 69.0%, and 60.2%, respectively (p = 0.001). After multivariable adjustment, patients with mrEF and rEF had comparable 30-day all-cause mortality (hazard ratio [HR] = 0.81, 95% confidence interval [CI] 0.50 to 1.33, p = 0.404), and pEF was associated with decreased risk of 30-day all-cause mortality compared with rEF (HR = 0.41, 95% CI 0.24 to 0.71, p = 0.001). In contrast, the risk of 30-day MACE in mrEF and pEF were lower than that of rEF (HR = 0.62, 95% CI 0.40 to 0.96, p = 0.031 and HR = 0.53, 95% CI 0.34 to 0.80, p = 0.003, respectively). In conclusion, 1/3 of patients with acute myocardial infarction complicated by cardiogenic shock were mrEF. The clinical characteristics and short-term mortality in patients with mrEF were inclined to that of rEF and the occurrence of early left ventricular systolic dysfunction is of prognostic significance.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am J Cardiol: 14 Mar 2022; 167:20-26
Jiang Y, Boris AF, Zhu Y, Gan H, ... Luo S, Huang B
Am J Cardiol: 14 Mar 2022; 167:20-26 | PMID: 34986988
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Impact:
Abstract

Gender Differences in Age-Stratified Inhospital Outcomes After Transcatheter Aortic Valve Implantation (from the National Inpatient Sample 2012 to 2018).

Zahid S, Khan MZ, Ullah W, Rai D, ... Depta JP, Michos ED
Contemporary data on gender differences in outcomes after transcatheter aortic valve implantation (TAVI), after stratification by age, remain limited. We studied age-stratified (60 to 70, 71 to 80, and 81 to 90 years) inhospital outcomes by gender after TAVI from the National Inpatient Sample database between 2012 and 2018. We analyzed National Inpatient Sample data using the International Classification of Diseases, Clinical Modification, Ninth Revision, and Tenth Revision claims codes. Between the years 2012 and 2018, a total of 188,325 weighted hospitalizations for TAVI were included in the analysis. A total of 21,957 patients were included in the 60 to 70 age group (44% females), 60,770 (45% females) in the 71 to 80 age group, and 105,580 (50% females) in the 81 to 90 age groups, respectively. Propensity-matched inhospital mortality rates were significantly higher for females than males for the age group of 81 to 90 years (3.0% vs 2.1%, p <0.01). Vascular complications and a need for blood transfusions remained significantly higher for females on propensity-matched analysis across all categories of ages. Conversely, acute kidney injury and the need for pacemaker implantation remained significantly higher for males across all age groups. In conclusion, we report that mortality is higher in female patients who underwent TAVI between the ages of 81 to 90. Moreover, the female gender was associated with higher vascular complications and bleeding requiring transfusions. Conversely, the male gender was associated with higher rates of pacemaker implantation and acute kidney injury.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am J Cardiol: 14 Mar 2022; 167:83-92
Zahid S, Khan MZ, Ullah W, Rai D, ... Depta JP, Michos ED
Am J Cardiol: 14 Mar 2022; 167:83-92 | PMID: 34991843
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Impact:
Abstract

Optical Coherence Tomographic Features of Pancoronary Plaques in Patients With Acute Myocardial Infarction Caused by Layered Plaque Rupture Versus Layered Plaque Erosion.

Yin Y, Fang C, Jiang S, Wang J, ... Dai J, Yu B
Atherosclerotic plaque instability could occur on the basis of healed plaque which has a layered appearance on optical coherence tomography. This study aimed to investigate pancoronary plaque features of layered plaque rupture (LPR) and layered plaque erosion (LPE) in patients with acute myocardial infarction. Among 388 patients with acute myocardial infarction who underwent preintervention optical coherence tomography imaging of three coronary arteries, 190 patients with layered culprit plaque (49.0%) were identified and further divided into 2 groups: LPR group and LPE group. Clinical characteristics, pancoronary plaque features and clinical outcomes were compared between the 2 groups. Patients with LPR were older, less often male and current smoker, and had a lower coronary flow grade than those with LPE. At the culprit lesion, LPR group had a higher prevalence of lipid plaque, thin-cap fibroatheroma (TCFA), macrophage, and microchannel, and presented with more severe lumen area stenosis than LPE group. At nonculprit lesions, LPR group had a higher prevalence of TCFA and had greater layered tissue thickness and area than LPE group. The ischemia-driven revascularization rate was higher in LPR group. Moreover, we found that TCFA, diameter stenosis >56.5%, and mean lipid arc >179.1° were predictors for layered culprit plaque. In conclusion, patients with LPR had more vulnerable plaque features at culprit and nonculprit lesions and had higher incidence of ischemia-driven revascularization than those with LPE. TCFA, diameter stenosis >56.5%, and mean lipid arc >179.1° were predictors of layered culprit plaque.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am J Cardiol: 14 Mar 2022; 167:35-42
Yin Y, Fang C, Jiang S, Wang J, ... Dai J, Yu B
Am J Cardiol: 14 Mar 2022; 167:35-42 | PMID: 34991841
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Impact:
Abstract

Polygenic Risk Scores for Predicting Adverse Outcomes After Coronary Revascularization.

Aittokallio J, Kauko A, Vaura F, Salomaa V, ... Schnabel RB, Niiranen T
Coronary procedures predispose patients to adverse events. To improve our understanding of the genetic factors underlying postoperative prognosis, we studied the association of polygenic risk scores (PRSs) with postprocedural complications in coronary patients who underwent revascularization. The study sample comprised 8,296, 6,132, and 13,082 patients who underwent percutaneous coronary intervention, coronary artery bypass grafting, or any revascularization, respectively. We genotyped all subjects and identified adverse events during follow-up of up to 30 years by record linkage with nationwide healthcare registers. We computed PRSs for each postoperative adverse outcome (atrial fibrillation [AF], myocardial infarction, stroke, and bleeding complications) for all participants. Cox proportional hazards models were used to examine the association between PRSs and outcomes. A 1-SD increase in AF-PRS was associated with greater risk of postoperative AF with hazard ratios of 1.22 (95% confidence interval [CI] 1.16 to 1.28), 1.15 (95% CI 1.10 to 1.20) and 1.18 (95% CI 1.14 to 1.22) after percutaneous coronary intervention, coronary artery bypass grafting, and any revascularization, respectively. In contrast, the association of each PRSs with other postoperative complications was nonexistent to marginal. Inclusion of the AF-PRS in a model with a clinical risk score resulted in significant model improvement (increase in model c-statistic 0.0059 to 0.0098 depending on procedure; p <0.0002 for all). In conclusion, our results demonstrate that PRS can be used for AF risk-prediction in patients who underwent revascularization. The AF-PRS could potentially be used to improve AF prevention and outcomes in patients who underwent revascularization.

Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.

Am J Cardiol: 14 Mar 2022; 167:9-14
Aittokallio J, Kauko A, Vaura F, Salomaa V, ... Schnabel RB, Niiranen T
Am J Cardiol: 14 Mar 2022; 167:9-14 | PMID: 34998506
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Impact:
Abstract

Long-term outcomes in inferior ST-segment elevation myocardial infarction patients with right ventricular myocardial infarction.

Hu M, Lu Y, Wan S, Li B, ... Yang Y, China Acute Myocardial Infarction Registry Investigators
Objective
To evaluate the prognostic influence of the presence of right ventricular myocardial infarction (RVMI) on patients with inferior ST-segment elevation myocardial infarction (STEMI) in the contemporary reperfusion era.
Methods
9308 patients with inferior STEMI were included from the prospective, nationwide, multicenter China Acute Myocardial Infarction Registry, including 1745 (18.75%) patients with RVMI and 7563 (81.25%) patients without RVMI. The primary outcome was two-year all-cause mortality. The secondary outcome was major adverse cardiac and cerebrovascular event (MACCE) defined as a composite of all-cause mortality, recurrent MI, revascularization, stroke, and major bleeding.
Results
After two-year follow up, there were no significant differences between inferior STEMI patients with or without RVMI in all-cause mortality (12.0% vs 11.3%; adjusted HR: 1.05; 95% CI: 0.90 to 1.24; P = 0.5103). Inferior STEMI with RVMI was associated with higher risk of MACCE (25.6% vs 22.0%; adjusted HR: 1.17; 95% CI: 1.05 to 1.31; P = 0.0038), revascularization (10.3% vs 8.1%; adjusted HR: 1.23; 95% CI: 1.03 to 1.48; P = 0.0218), and major bleeding (4.6% vs 2.7%; adjusted HR: 1.56; 95% CI: 1.18 to 2.07; P = 0.0019). Primary percutaneous coronary intervention (PCI) and thrombolysis were independent predictors to decrease all-cause mortality. For patients who received timely reperfusion, RVMI involvement did not increase all-cause mortality, whereas for those who did not undergo reperfusion, RVMI increased all-cause mortality (20.3% vs 15.7%; HR: 1.34; 95% CI: 1.10 to 1.63).
Conclusion
RVMI did not increase all-cause mortality for inferior STEMI patients in contemporary reperfusion era, whereas the risk was increased for patients with no reperfusion treatment.

Copyright © 2022 Elsevier B.V. All rights reserved.

Int J Cardiol: 14 Mar 2022; 351:1-7
Hu M, Lu Y, Wan S, Li B, ... Yang Y, China Acute Myocardial Infarction Registry Investigators
Int J Cardiol: 14 Mar 2022; 351:1-7 | PMID: 34998947
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Impact:
Abstract

Long-Term Outcomes for Patients With Acute Coronary Syndrome and Nonvalvular Atrial Fibrillation.

Gouda P, Dover DC, Savu A, Bainey K, ... Kaul P, Sandhu RK
Short-term outcomes are worse for patients with acute coronary syndrome (ACS) with a history of nonvalvular atrial fibrillation (NVAF). However, long-term prognosis remains unclear. We linked administrative health databases to identify patients hospitalized with ACS (ST-elevation myocardial infarction [STEMI], non-STEMI [NSTEMI], and unstable angina) between 2008 and 2019 in Alberta, Canada. Patients were stratified according to history of NVAF before hospitalization. The primary outcome was a composite of all-cause mortality, hospitalization for myocardial infarction, or stroke at 3 years. Cox models were constructed to estimate the association between ACS, NVAF, and outcomes. Of 54,309 ACS hospitalizations, 6,351 patients (11.7%) had a history of NVAF. Compared with patients without NVAF, patients with previous NVAF were older (75.6 ± 11.6 vs 64.9 ± 13.4 years), women (35.1% vs 30.0%), had higher comorbid burden (Charlson co-morbidity index 3.0 vs 1.0), and more often presented with NSTEMI (57.5% vs 49.0%). The primary outcome occurred in 37.0% of patients with previous NVAF and 17.4% without (p <0.001). In the multivariable analysis, there was a 1.14-fold (95% confidence interval [CI] 1.09 to 1.20) higher risk of the primary outcome in patients with previous NVAF. There was a significant association with STEMI (adjusted harazard ratio [aHR] 1.24, 95% CI 1.12 to 1.36) and NSTEMI (aHR 1.12, 95% CI 1.06 to 1.19) but not with unstable angina (aHR 1.04, 95% CI 0.90 to 1.22). In conclusion, in this population-based study, we identified that a history of NVAF at ACS presentation is associated with worse long-term prognosis, particularly for STEMI and NSTEMI.

Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.

Am J Cardiol: 14 Mar 2022; 167:54-61
Gouda P, Dover DC, Savu A, Bainey K, ... Kaul P, Sandhu RK
Am J Cardiol: 14 Mar 2022; 167:54-61 | PMID: 35012753
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Impact:
Abstract

Impact of Race/Ethnicity on Long Term Outcomes After Percutaneous Coronary Intervention with Drug-Eluting Stents.

Roumeliotis A, Claessen B, Sartori S, Cao D, ... Dangas G, Mehran R
Cardiovascular disease constitutes the leading cause of mortality worldwide, irrespective of race/ethnicity. Previous studies have shown that minority patients with acute coronary syndrome have distinct clinical, anatomic, and socioeconomic characteristics which may affect clinical outcomes. We included patients who underwent percutaneous coronary intervention with drug-eluting stents for ST-segment elevation myocardial infarction (STEMI), non-STEMI, or unstable angina in a single center. Patients were stratified into Caucasian, African-American, Hispanic, and Asian. Caucasians were the reference group. The primary end point was major adverse cardiac and cerebrovascular events, composite of death, spontaneous myocardial infarction, or stroke at 1 year. Of 6,800 patients included, 49.7% were Caucasian, 20.7% Hispanic, 17.0% Asian and 12.6% African-American. Caucasians were the oldest, Hispanics and Asians had the highest prevalence of diabetes mellitus whereas African-Americans had more chronic kidney disease. Hispanics and African-Americans had the highest STEMI rates, whereas Asians were more likely to present with unstable angina. Compared with Caucasians, Asians had a lower rate of major adverse cardiac and cerebrovascular events at 1 year (3.9% vs 7.1%; p <0.01) whereas Hispanics (6.2% vs 7.1%; p = 0.17) and African-Americans (8.0% vs 7.1%; p = 0.38) had comparable outcomes. Differences were driven by mortality. Findings remained unchanged after adjustment. In conclusion, in acute coronary syndrome patients who underwent percutaneous coronary intervention, Asian race/ethnicity was associated with favorable cardiovascular outcomes compared with Caucasians. No significant differences were observed for Hispanics and African-Americans.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am J Cardiol: 14 Mar 2022; 167:1-8
Roumeliotis A, Claessen B, Sartori S, Cao D, ... Dangas G, Mehran R
Am J Cardiol: 14 Mar 2022; 167:1-8 | PMID: 35031109
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Impact:
Abstract

Improved Outcomes Following the Ross Procedure Compared With Bioprosthetic Aortic Valve Replacement.

Mazine A, David TE, Stoklosa K, Chung J, Lafreniere-Roula M, Ouzounian M
Background
The ideal aortic valve substitute for young and middle-aged adults remains elusive.
Objectives
This study sought to compare the long-term outcomes of patients undergoing the Ross procedure and those receiving bioprosthetic aortic valve replacements (AVRs).
Methods
Consecutive patients aged 16-60 years who underwent a Ross procedure or surgical bioprosthetic AVR at the Toronto General Hospital between 1990 and 2014 were identified. Propensity score matching was used to account for differences in baseline characteristics. The primary outcome was all-cause mortality. Secondary outcomes included valve reintervention, valve deterioration, endocarditis, thromboembolic events, and permanent pacemaker implantation.
Results
Propensity score matching yielded 108 pairs of patients. The median age was 41 years (IQR: 34-47 years). Baseline characteristics were similar between the matched groups. There was no operative mortality in either group. Mean follow-up was 14.5 ± 7.2 years. All-cause mortality was lower following the Ross procedure (HR: 0.35; 95% CI: 0.14-0.90; P = 0.028). Using death as a competing risk, the Ross procedure was associated with lower rates of reintervention (HR: 0.21; 95% CI: 0.10-0.41; P < 0.001), valve deterioration (HR: 0.25; 95% CI: 0.14-0.45; P < 0.001), thromboembolic events (HR: 0.15; 95% CI: 0.05-0.50; P = 0.002), and permanent pacemaker implantation (HR: 0.22; 95% CI: 0.07-0.64; P = 0.006).
Conclusions
In this propensity-matched study, the Ross procedure was associated with better long-term survival and freedom from adverse valve-related events compared with bioprosthetic AVR. In specialized centers with sufficient expertise, the Ross procedure should be considered the primary option for young and middle-aged adults undergoing AVR.

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

J Am Coll Cardiol: 14 Mar 2022; 79:993-1005
Mazine A, David TE, Stoklosa K, Chung J, Lafreniere-Roula M, Ouzounian M
J Am Coll Cardiol: 14 Mar 2022; 79:993-1005 | PMID: 35272805
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Impact:
Abstract

Sirolimus-eluting stents with ultrathin struts versus everolimus-eluting stents for patients undergoing percutaneous coronary intervention: final three-year results of the TALENT trial.

de Winter RJ, Zaman A, Hara H, Gao C, ... Onuma Y, Serruys PW
Background
In the TALENT study, the sirolimus-eluting ultrathin strut Supraflex stent was non-inferior to the XIENCE stent for a device-oriented composite endpoint (DoCE: defined as cardiac death, target-vessel myocardial infarction [TV-MI], or clinically indicated target lesion revascularisation [CI-TLR]) at 12 months.
Aims
This study investigated the 3-year outcomes of the TALENT trial and long-term impact of ultrathin drug-eluting stents (DES), compared to the XIENCE everolimus-eluting thin stent.
Methods
The TALENT trial is a prospective, multicentre, randomised all-comers trial comparing the Supraflex sirolimus-eluting stent with the XIENCE everolimus-eluting stent, with planned follow-up for 3 years.
Results
The TALENT trial enrolled 1,435 patients (Supraflex n=720, XIENCE n=715) with 3-year follow-up data available in 97.8% in the Supraflex group, and in 98.9% in the XIENCE group. At 3 years, DoCE occurred in 57 patients (8.1%) in the Supraflex group, and in 66 patients (9.4%) in the XIENCE group (p=0.406). There were no significant between-group differences in rates of cardiac death, TV-MI or CI-TLR. The rates of definite or probable stent thrombosis were low and similar between groups (1.1% vs 1.4%; p=0.640). In a meta-analysis of long-term follow-up (3-5 years), ultrathin strut DES tended to reduce DoCE (relative risk 0.89 [0.79-1.01]; p=0.068), compared to thicker strut DES. The risks for cardiac death and definite or probable stent thrombosis were similar between ultrathin strut DES and thicker strut DES.
Conclusions
At 3-year follow-up, the use of the Supraflex stent was at least as safe and efficacious as the XIENCE stent in an all-comers population.
Clinicaltrials
gov: NCT02870140.



EuroIntervention: 14 Mar 2022; epub ahead of print
de Winter RJ, Zaman A, Hara H, Gao C, ... Onuma Y, Serruys PW
EuroIntervention: 14 Mar 2022; epub ahead of print | PMID: 35285804
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Impact:
Abstract

Characteristics and clinical outcomes in patients with prior chest radiation undergoing TAVR: Observations from PARTNER-2.

Mohanty BD, Coylewright M, Sequeira AR, Shin D, ... Leon MB, Malenka D
Objectives
The purpose of this study is to investigate the viability of transcatheter aortic valve replacement (TAVR) for severe symptomatic aortic stenosis (AS) in patients with prior chest radiation therapy (cXRT).
Background
Since patients with prior cXRT perform poorly with surgical aortic valve replacement, TAVR can be a viable alternative. However, clinical outcomes after TAVR in this patient population have not been well studied.
Methods
From the pooled registry of the placement of aortic transcatheter valves II trial, we identified patients with and without prior cXRT who underwent TAVR (n = 64 and 3923, respectively). The primary outcome was a composite of all-cause death and any stroke at 2 years. Time to event analyses were shown as Kaplan-Meier event rates and compared by log-rank testing. Hazard ratios (HRs) were estimated and compared by Cox proportional hazards regression model.
Results
There was no significant difference in the primary outcome between the patients with and without prior cXRT (30.7% vs. 27.0%; p = 0.75; HR, 1.08; 95% confidence interval, 0.66-1.77). Rates of myocardial infarction, vascular complications, acute kidney injury, or new pacemaker implant after TAVR were not statistically different between the two groups. The rate of immediate reintervention with a second valve for aortic regurgitation after TAVR was higher among the patients with prior cXRT. However, no further difference was observed during 2 years follow-up after discharge from the index-procedure hospitalization.
Conclusions
TAVR is a viable alternative for severe symptomatic AS in patients who had cXRT in the past.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Mar 2022; epub ahead of print
Mohanty BD, Coylewright M, Sequeira AR, Shin D, ... Leon MB, Malenka D
Catheter Cardiovasc Interv: 14 Mar 2022; epub ahead of print | PMID: 35289473
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Impact:
Abstract

Effect of prehospital treatment in STEMI patients undergoing primary PCI.

Fabris E, Menzio S, Gregorio C, Pezzato A, ... Van\'t Hof AW, Sinagra G
Background
The appropriate timing to administer antithrombotic therapies in ST-elevation myocardial infarction (STEMI) remains uncertain. This study aims to evaluate the role of antithrombotic therapy administration at first medical contact (FMC) compared with the administration in the Cathlab.
Methods
We conducted a \"before-after\" observational study enrolling STEMI undergoing primary percutaneous coronary intervention (PCI). Outcomes were evaluated during two successive periods, before (control group: aspirin only at FMC) and after (pretreated intervention group: heparin, aspirin plus ticagrelor at FMC) the introduction of a new regional pretreatment protocol.
Results
A total of 537 consecutive patients (300 in control vs. 237 in intervention group) were enrolled. The pretreated compared with no pretreated population showed better basal reperfusion, expressed as basal Thrombolysis in Myocardial Infarction (TIMI)-flow (p for trend p < 0.001). Pretreated population showed lower frequency of TIMI 0 (56.5% vs. 73.7%, odds ratio [OR]: 0.46, 95% confidence interval [CI]: 0.32-0.67, p < 0.001) and higher frequency of TIMI 2-3 (33.3% vs. 19.3% OR: 2.0, 95% CI: 1.38-2.00, p < 0.001) and TIMI 3 (14.3% vs. 9.7%, OR: 1.56, 95% CI: (0.92-2.65), p = 0.094). Pretreated compared with no pretreated population showed reduced infarct size expressed as Troponin Peak (20,286 (8726-75,027) versus 48,676 (17,229-113,900), p = 0.001), and higher left ventricular ejection fraction at discharge (53% (44-59) vs. 50% (44-56), p = 0.027). In-hospital BARC ≥ 2 bleeding were similar (2.1% vs. 2.0%, p = 0.929, in pretreated versus no pretreated population, respectively).
Conclusion
This study provides support for an early pretreatment strategy in STEMI patients and confirmed the importance of an efficient organization of STEMI networks which allow initiation of antithrombotic treatment at FMC.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Mar 2022; epub ahead of print
Fabris E, Menzio S, Gregorio C, Pezzato A, ... Van't Hof AW, Sinagra G
Catheter Cardiovasc Interv: 14 Mar 2022; epub ahead of print | PMID: 35289471
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Impact:
Abstract

Temporal Changes in Pollen Concentration Predict Short-Term Clinical Outcomes in Acute Coronary Syndromes.

Al-Mukhtar O, Vogrin S, Lampugnani ER, Noaman S, ... Stub D, Chan W

Background:
Atmospheric changes in pollen concentration may affect human health by triggering various allergic processes. We sought to assess if changes in pollen concentrations were associated with different acute coronary syndrome (ACS) subtype presentations and short-term clinical outcomes. Methods and Results We analyzed data in consecutive patients presenting with ACS (unstable angina, non-ST-segment-elevation myocardial infarction, and ST-segment-elevation myocardial infarction) treated with percutaneous coronary intervention between January 2014 and December 2017 and enrolled in the VCOR (Victorian Cardiac Outcomes Registry). Baseline characteristics were compared among patients exposed to different grass and total pollen concentrations. The primary outcome was occurrence of ACS subtypes and 30-day major adverse cardiac and cerebrovascular events (composite of mortality, myocardial infarction, stent thrombosis, target vessel revascularization, or stroke). Of 15 379 patients, 7122 (46.3%) presented with ST-segment-elevation myocardial infarction, 6781 (44.1%) with non-ST-segment-elevation myocardial infarction, and 1476 (9.6%) with unstable angina. The mean age was 62.5 years, with men comprising 76% of patients. No association was observed between daily or seasonal grass and total pollen concentrations with the frequency of ACS subtype presentation. However, grass and total pollen concentrations in the preceding days (2-day average for grass pollen and 7-day average for total pollen) correlated with in-hospital mortality (odds ratio [OR], 2.17 [95% CI, 1.12-4.21]; P=0.021 and OR, 2.78 [95% CI, 1.00-7.74]; P=0.05), respectively, with a trend of 2-day grass pollen for 30-day major adverse cardiac and cerebrovascular events (OR, 1.50 [95% CI, 0.97-2.32]; P=0.066).
Conclusions:
Increased pollen concentrations were not associated with differential ACS subtype presentation but were significantly related to in-hospital mortality following percutaneous coronary intervention, underscoring a potential biologic link between pollen exposure and clinical outcomes.




J Am Heart Assoc: 14 Mar 2022:e023036; epub ahead of print
Al-Mukhtar O, Vogrin S, Lampugnani ER, Noaman S, ... Stub D, Chan W
J Am Heart Assoc: 14 Mar 2022:e023036; epub ahead of print | PMID: 35289185
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Impact:
Abstract

Left main coronary artery compression by dilated pulmonary artery in pulmonary arterial hypertension: a systematic review and meta-analysis.

Badea R, Dorobantu DM, Sharabiani MTA, Predescu LM, Coman IM, Ginghina C
Objective
Pulmonary arterial hypertension (PAH) can lead to left main coronary artery compression (LMCo), but data on the impact, screening and treatment are limited. A meta-analysis of LMCo cases could fill the knowledge gaps in this topic.
Methods
Electronic databases were searched for all LMCo/PAH studies, abstracts and case reports including pulmonary artery (PA) size. Restricted maximum likelihood meta-analysis was used to evaluate LMCo-associated factors. Specificity, sensitivity and accuracy of PA size thresholds for diagnosis of LMCo were calculated. Treatment options and outcomes were summarized.
Results
A total of five case-control cohorts and 64 case reports/series (196 LMCo and 438 controls) were included. LMCo cases had higher PA diameter (Hedge\'s g 1.46 [1.09; 1.82]), PA/aorta ratio (Hedge\'s g 1.1 [0.64; 1.55]) and probability of CHD (log odds-ratio 1.22 [0.54; 1.9]) compared to non-LMCo, but not PA pressure or vascular resistance. A 40 mm cut-off for the PA diameter had balanced sensitivity (80.5%), specificity (79%) and accuracy (79.7%) for LMCo diagnosis, while a value of 44 mm had higher accuracy (81.7%), higher specificity (91.5%) but lower sensitivity (71.9%). Pooled mortality after non-conservative treatment (n = 150, predominantly stenting) was 2.7% at up to 22 months of mean follow-up, with 83% survivors having no angina at follow-up.
Conclusion
PA diameter, PA/aorta ratio and CHD are associated with LMCo, while hemodynamic parameters are not. Data from this study support that a PA diameter cut-off between 40 and 44 mm can offer optimal accuracy for LMCo screening. Preferred treatment was coronary stenting, associated with low mid-term mortality and symptom relief. Diagnosis and management of left main coronary artery compression (LMCo) in patients with pulmonary arterial hypertension (PAH).

© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.

Clin Res Cardiol: 14 Mar 2022; epub ahead of print
Badea R, Dorobantu DM, Sharabiani MTA, Predescu LM, Coman IM, Ginghina C
Clin Res Cardiol: 14 Mar 2022; epub ahead of print | PMID: 35290496
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Impact:
Abstract

The Impact of Intravascular Ultrasound on Femoropopliteal Artery Endovascular Interventions: A Randomized Controlled Trial.

Allan RB, Puckridge PJ, Spark JI, Delaney CL
Objectives
The aim of this study was to investigate whether the addition of intravascular ultrasound (IVUS) guidance during femoropopliteal artery interventions reduced the rate of binary restenosis within 12 months compared with angiographic guidance alone.
Background
IVUS is more accurate than angiography for assessment of vessel size and disease severity. Low-level studies suggest that the use of IVUS in femoropopliteal endovascular interventions improves outcomes, but currently, no level 1 evidence exists.
Methods
This was a prospective single-center trial of 150 patients undergoing femoropopliteal endovascular intervention, randomized (1:1) to guidance by angiography or angiography and IVUS. The primary outcome measure was freedom from binary restenosis, on duplex ultrasound, within 12 months. Secondary outcomes included clinically driven target lesion revascularization, disagreements in imaging findings between modalities, and changes in treatment caused by IVUS.
Results
Freedom from binary restenosis at 12 months was significantly higher in the IVUS group (72.4% vs 55.4%; P = 0.008). There was no significant difference between groups for clinically directed target lesion revascularization (84.2% and 82.4%; P = 0.776). Mean vessel diameter was significantly larger with IVUS (5.60 mm vs 5.10 mm; P < 0.001). A change in treatment occurred caused by IVUS in 79% of cases. Binary restenosis was lower in the IVUS group for cases treated with drug-coated balloons (9.1% vs 37.5%; P = 0.001).
Conclusions
The use of IVUS resulted in a significant reduction in the rate of restenosis after endovascular intervention. This is the first randomized controlled trial to demonstrate that IVUS improves outcomes in femoropopliteal interventions. This benefit may primarily relate to cases treated with drug-coated balloons. (Does the use of intravascular ultrasound improve outcomes of endovascular interventional procedures for peripheral vascular disease of the superficial femoral artery or popliteal artery?; ACTRN12614000006640).

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 13 Mar 2022; 15:536-546
Allan RB, Puckridge PJ, Spark JI, Delaney CL
JACC Cardiovasc Interv: 13 Mar 2022; 15:536-546 | PMID: 35272779
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Impact:
Abstract

The PARTNER 3 Bicuspid Registry for Transcatheter Aortic Valve Replacement in Low-Surgical-Risk Patients.

Williams MR, Jilaihawi H, Makkar R, O\'Neill WW, ... Lu M, Webb JG
Objectives
The study compared 1-year outcomes between transcatheter aortic valve replacement (TAVR) patients with bicuspid aortic valve (BAV) morphology and clinically similar patients having tricuspid aortic valve (TAV) morphology.
Background
There are limited prospective data on TAVR using the SAPIEN 3 device in low-surgical-risk patients with severe, symptomatic aortic stenosis and bicuspid anatomy.
Methods
Low-risk, severe aortic stenosis patients with BAV were candidates for the PARTNER 3 (Placement of Aortic Transcatheter Valves 3) (P3) bicuspid registry or the P3 bicuspid continued access protocol. Patients treated in these registries were pooled and propensity score matched to TAV patients from the P3 randomized TAVR trial. Outcomes were compared between groups. The primary endpoint was the 1-year composite rate of death, stroke, and cardiovascular rehospitalization.
Results
Of 320 total submitted BAV patients, 169 (53%) were treated, and most were Sievers type 1. The remaining 151 patients were excluded caused by anatomic or clinical criteria. Propensity score matching with the P3 TAVR cohort (496 patients) yielded 148 pairs. There were no differences in baseline clinical characteristics; however, BAV patients had larger annuli and they experienced longer procedure duration. There was no difference in the primary endpoint between BAV and TAV (10.9% vs 10.2%; P = 0.80) or in the rates of the individual components (death: 0.7% vs 1.4%; P = 0.58; stroke: 2.1% vs 2.0%; P = 0.99; cardiovascular rehospitalization: 9.6% vs 9.5%; P = 0.96).
Conclusions
Among highly select bicuspid aortic stenosis low-surgical-risk patients without extensive raphe or subannular calcification, TAVR with the SAPIEN 3 valve demonstrated similar outcomes to a matched cohort of patients with tricuspid aortic stenosis.

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 13 Mar 2022; 15:523-532
Williams MR, Jilaihawi H, Makkar R, O'Neill WW, ... Lu M, Webb JG
JACC Cardiovasc Interv: 13 Mar 2022; 15:523-532 | PMID: 35272777
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Impact:
Abstract

Propensity-Matched 1-Year Outcomes Following Transcatheter Aortic Valve Replacement in Low-Risk Bicuspid and Tricuspid Patients.

Deeb GM, Reardon MJ, Ramlawi B, Yakubov SJ, ... Huang J, Forrest JK
Objectives
The aim of this study was to compare 1-year outcomes after transcatheter aortic valve replacement (TAVR) in low surgical risk patients with bicuspid aortic stenosis to patients with tricuspid aortic stenosis.
Background
The pivotal TAVR trials excluded patients with bicuspid aortic valves. The Low Risk Bicuspid Study 30-day primary endpoint of death or disabling stroke was 1.3%.
Methods
The Low Risk Bicuspid Study is a prospective, single-arm, TAVR trial that enrolled patients from 25 U.S. sites. A screening committee confirmed bicuspid anatomy and valve classification on computed tomography using the Sievers classification. Valve sizing was by annular measurements. An independent clinical events committee adjudicated all serious adverse events, and an independent core laboratory assessed all echocardiograms. The 150 patients from the Low Risk Bicuspid Study were propensity matched to the TAVR patients in the randomized Evolut Low Risk Trial using the 1:1 5- to-1-digit greedy method, resulting in 145 pairs.
Results
All-cause mortality or disabling stroke at 1 year was 1.4% in the bicuspid and 2.8% in the tricuspid group (P = 0.413). A pacemaker was implanted in 16.6% of bicuspid and 17.9% of tricuspid patients (P = 0.741). The effective orifice area was similar between groups at 1 year (2.2 ± 0.7 cm2 vs 2.3 ± 0.6 cm2, P = 0.677) as was the mean gradient (8.7 ± 3.9 mm Hg vs 8.5 ± 3.1 mm Hg, P = 0.754). Fewer patients in the bicuspid group had mild or worse paravalvular leak (21.3% vs 42.6%, P < 0.001).
Conclusions
There were no significant differences in clinical or forward flow hemodynamic outcomes between the propensity-matched groups at 1 year.

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 13 Mar 2022; 15:511-522
Deeb GM, Reardon MJ, Ramlawi B, Yakubov SJ, ... Huang J, Forrest JK
JACC Cardiovasc Interv: 13 Mar 2022; 15:511-522 | PMID: 35272776
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Impact:
Abstract

Risk Assessment of Coronary Obstruction During Transcatheter Aortic Valve Replacement: Insights From Post-BASILICA Computed Tomography.

Kitamura M, Wilde J, Dumpies O, Richter I, ... Holzhey D, Abdel-Wahab M
Objectives
The aim of this study was to examine the predictive value of preprocedural computed tomography (CT)-based risk stratification of coronary obstruction during transcatheter aortic valve replacement (TAVR) on the basis of geometric measurements on postprocedural CT.
Background
Proper patient selection for additional procedures to prevent coronary obstruction during TAVR has not been adequately evaluated.
Methods
Pre- and postprocedural computed tomographic scans of 28 patients treated using bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA) and TAVR were analyzed. Using the postprocedural computed tomographic images, threatened coronary obstruction (TCO) was defined as: 1) ostial obstruction (adherence of the transcatheter heart valve [THV] to the coronary ostium with leaflet extension above the ostium); and/or 2) sinus sequestration (THV adherence to the sinotubular junction [STJ] with leaflet extension above the STJ) and was substratified into complete and incomplete types.
Results
A total of 51 leaflets were evaluated (88% surgical tissue valves) after excluding leaflets not visible on CT (n = 5). On postprocedural CT, complete TCO was observed in 25.4% (13 of 51 leaflets). On preprocedural CT, leaflets were at high risk for complete TCO (incidence 53%) if the virtual THV-to-coronary distance (VTC) was <3.0 mm, or if the virtual THV-to-STJ distance (VTSTJ) was <1.0 mm with STJ height - leaflet length <0 mm (leaflet-STJ mismatch). Leaflets were at low risk (incidence 0%) if the VTC was ≥3 mm and VTSTJ was ≥3.0 mm or STJ height - leaflet length was ≥+2.0 mm. Of 28 leaflets treated using BASILICA, complete TCO was seen in 35.7% (n = 10), due to sinus sequestration (100%) with coexisting ostial obstruction (30%). Actual coronary events occurred in 7.1% (n = 2) because of leaflet prolapse, corresponding to an absolute risk reduction by BASILICA of 29% (P = 0.021).
Conclusions
Risk assessment of coronary obstruction after TAVR may improve with a multiparametric approach incorporating VTC, VTSTJ, and leaflet-STJ mismatch. BASILICA appeared to reduce actual coronary events even in leaflets with anticipated coronary obstruction.

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 13 Mar 2022; 15:496-507
Kitamura M, Wilde J, Dumpies O, Richter I, ... Holzhey D, Abdel-Wahab M
JACC Cardiovasc Interv: 13 Mar 2022; 15:496-507 | PMID: 35272774
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Impact:
Abstract

Transcatheter Tricuspid Valve Replacement With the EVOQUE System: 1-Year Outcomes of a Multicenter, First-in-Human Experience.

Webb JG, Chuang AM, Meier D, von Bardeleben RS, ... Hahn RT, Fam NP
Objectives
The aim of this study was to report the midterm outcomes at 1 year in the expanded first-in-human experience with the transfemoral EVOQUE system (Edwards Lifesciences) for tricuspid regurgitation (TR).
Background
Untreated TR is associated with excess mortality and morbidity. The first-in-human experience with the EVOQUE tricuspid valve replacement system reported favorable 30-day outcomes with no mortality in a compassionate use population.
Methods
Twenty-seven patients with severe TR were treated with the EVOQUE system in a compassionate use experience at 7 centers between May 2019 and July 2020. All patients had clinical right-sided heart failure (HF) and were deemed inoperable and unsuitable for transcatheter edge-to-edge repair by the institutional heart teams. The clinical outcomes collected included all-cause mortality, symptom status, TR severity, HF hospitalization, and major adverse cardiovascular events.
Results
At baseline, all patients (age: 77 ± 8 years, 89% female) were at high surgical risk (mean Society of Thoracic Surgeons score: 8.6% ± 5.5%), with 89% New York Heart Association functional class III/IV. TR was predominantly functional in etiology (19/27, 70%). At 1 year, mortality was 7% (2/27), 70% of patients were New York Heart Association functional class I/II, and 96% and 87% of patients had a TR grade ≤2+ and ≤1+, respectively. Between 30 days and 1 year, 2 patients experienced HF hospitalizations, and 1 patient required a new pacemaker implantation.
Conclusions
In this early, compassionate use experience, the transfemoral transcatheter EVOQUE tricuspid valve replacement system demonstrated durable efficacy, persistent improvement in symptom status, and low rates of mortality and HF hospitalizations at a 1-year follow-up. Further studies are underway to validate its efficacy.

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

JACC Cardiovasc Interv: 13 Mar 2022; 15:481-491
Webb JG, Chuang AM, Meier D, von Bardeleben RS, ... Hahn RT, Fam NP
JACC Cardiovasc Interv: 13 Mar 2022; 15:481-491 | PMID: 35272772
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Impact:
Abstract

Transfemoral Tricuspid Valve Replacement in Patients With Tricuspid Regurgitation: TRISCEND Study 30-Day Results.

Kodali S, Hahn RT, George I, Davidson CJ, ... Makkar R, TRISCEND Investigators
Objectives
The TRISCEND study (Edwards EVOQUE Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy after Replacement of Tricuspid Valve with Transcatheter Device) is evaluating the safety and performance of transfemoral transcatheter tricuspid valve replacement in patients with clinically significant tricuspid regurgitation (TR) and elevated surgical risk.
Background
Transcatheter valve replacement could lead to a paradigm shift in treating TR and improving patient quality of life.
Methods
In the prospective, single-arm, multicenter TRISCEND study, patients with symptomatic moderate or greater TR, despite medical therapy, underwent percutaneous transcatheter tricuspid valve replacement with the EVOQUE system. A composite rate of major adverse events, echocardiographic parameters, and clinical, functional, and quality-of-life measures were assessed at 30 days.
Results
Fifty-six patients (mean age of 79.3 years, 76.8% female, 91.1% TR severe or greater, 91.1% atrial fibrillation, and 87.5% New York Heart Association functional class III or IV) were treated. At 30 days, TR was reduced to mild or less in 98%. The composite major adverse events rate was 26.8% at 30 days caused by 1 cardiovascular death in a patient with a failed procedure, 2 reinterventions after device embolization, 1 major access site or vascular complication, and 15 severe bleeds, of which none were life-threatening or fatal. No myocardial infarction, stroke, renal failure, major cardiac structural complications, or device-related pulmonary embolism were observed. New York Heart Association significantly improved to functional class I or II (78.8%; P < 0.001), 6-minute walk distance improved 49.8 m (P < 0.001), and Kansas City Cardiomyopathy Questionnaire score improved 19 points (P < 0.001).
Conclusions
Early experience with the transfemoral EVOQUE system in patients with clinically significant TR demonstrated technical feasibility, acceptable safety, TR reduction, and symptomatic improvement at 30 days. The TRISCEND II randomized trial (NCT04482062) is underway.

Copyright © 2022. Published by Elsevier Inc.

JACC Cardiovasc Interv: 13 Mar 2022; 15:471-480
Kodali S, Hahn RT, George I, Davidson CJ, ... Makkar R, TRISCEND Investigators
JACC Cardiovasc Interv: 13 Mar 2022; 15:471-480 | PMID: 35272771
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Impact:
Abstract

Bioabsorbable polymer drug-eluting stents with 4-month dual antiplatelet therapy versus durable polymer drug-eluting stents with 12-month dual antiplatelet therapy in patients with left main coronary artery disease: the IDEAL-LM randomised trial.

van Geuns RJ, Chun-Chin C, McEntegart MB, Merkulov E, ... Onuma Y, Oldroyd KG
Background
Improvements in drug-eluting stent design have led to a reduced frequency of repeat revascularisation and new biodegradable polymer coatings may allow a shorter duration of dual-antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI).
Aims
The Improved Drug-Eluting stent for All-comers Left Main (IDEAL-LM) study aims to investigate long-term clinical outcomes after implantation of a biodegradable polymer platinum-chromium everolimus-eluting stent (BP-PtCr-EES) followed by 4 months DAPT compared to a durable polymer cobalt-chromium everolimus-eluting stent (DP-CoCr-EES) followed by 12 months DAPT in patients undergoing PCI of unprotected left main coronary artery (LMCA) disease.
Methods
This is a multicentre randomised clinical trial study in patients with an indication for coronary artery revascularisation who have been accepted for PCI of LMCA disease after Heart Team consultation. Patients were randomly assigned in a 1:1 ratio to receive either the BP-PtCr-EES or the DP-CoCr-EES. The primary endpoint was a non-inferiority comparison of the rate of major adverse cardiovascular events (MACE), defined as all-cause death, myocardial infarction, or ischaemia-driven target vessel revascularisation at 2 years.
Results
Between December 2014 and October 2016, 818 patients (410 BP-PtCr-EES and 408 DP-CoCr-EES) were enrolled at 29 centres in Europe. At 2 years, the primary endpoint of MACE occurred in 59 patients (14.6%) in the BP-PtCr-EES group and 45 patients (11.4%) in the DP-CoCr-EES group; 1-sided upper 95% confidence interval (CI) 7.18%; p=0.04 for non-inferiority; p=0.17 for superiority. The secondary endpoint event of BARC 3 or 5 bleeding occurred in 11 patients (2.7%) in the BP-PtCr-EES group and 2 patients (0.5%) in the DP-CoCr-EES group (p=0.02).
Conclusions
In patients undergoing PCI of LMCA disease, after two years of follow-up, the use of a BP-PtCr-EES with 4 months of DAPT was non-inferior to a DP-CoCr-EES with 12 months of DAPT with respect to the composite endpoint of all-cause death, myocardial infarction or ischaemia-driven target vessel revascularisation.



EuroIntervention: 13 Mar 2022; epub ahead of print
van Geuns RJ, Chun-Chin C, McEntegart MB, Merkulov E, ... Onuma Y, Oldroyd KG
EuroIntervention: 13 Mar 2022; epub ahead of print | PMID: 35285803
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Impact:
Abstract

Spontaneous Coronary Artery Dissection and Evidence-Based Medicine.

Baechler CJ, Witt DR, Lohese O, Benson G
Spontaneous coronary artery dissection (SCAD) is a relatively newly diagnosed area, and evidence-based medicine (EBM) standards are emerging and currently include an aspirin, β blocker, clopidogrel, angiotensin-converting enzyme inhibitor/angiotensin-receptor blocker for patients with hypertension, vascular abnormality imaging, and cardiac rehabilitation. Because SCAD is an uncommon condition, many providers are unfamiliar with EBM treatment standards which could affect the implementation of recommended treatment. This study documented the frequency of failure to meet EBM SCAD treatment standards and factors contributing to conformance failure. Patients who presented to a tertiary referral hospital from January 1, 2005, to July 6, 2020, were included. The electronic medical record was reviewed for EBM treatment. Patients who did not meet the criteria of EBM were contacted by phone for a phone interview. The study period included 118 patients with SCAD, 3 of whom (2.5%) died and were not eligible for this study. In the final cohort of 115 patients, the average age was 55 years, female gender (97%) and EBM standards were met in 30%. Of patients who participated in the phone interview, 38 (33%) reported frustration with SCAD misdiagnosis (39%), inadequate mental health resources (37%), and communication failure regarding the need for cardiologist follow-up (26%). Cardiac rehabilitation use was impacted by location, time of day, availability, and cost. The most common medication-limiting factor for β-blocker usage was fatigue (15%). Most (59%) patients did not undergo fibromuscular dysplasia imaging. In conclusion, in this 15-year SCAD study from a single tertiary care hospital SCAD registry, only 30% met the current EBM for SCAD. Unique solutions that are both patient-informed and evidence-driven are needed to achieve the best clinical outcomes.

Copyright © 2022 Elsevier Inc. All rights reserved.

Am J Cardiol: 11 Mar 2022; epub ahead of print
Baechler CJ, Witt DR, Lohese O, Benson G
Am J Cardiol: 11 Mar 2022; epub ahead of print | PMID: 35292147
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Impact:
Abstract

An automated software for real-time quantification of wall shear stress distribution in quantitative coronary angiography data.

Tufaro V, Torii R, Erdogan E, Kitslaar P, ... Aben JP, Bourantas CV
Background
Wall shear stress (WSS) estimated in 3D-quantitative coronary angiography (QCA) models appears to provide useful prognostic information and identifies high-risk patients and lesions. However, conventional computational fluid dynamics (CFD) analysis is cumbersome limiting its application in the clinical arena. This report introduces a user-friendly software that allows real-time WSS computation and examines its reproducibility and accuracy in assessing WSS distribution against conventional CFD analysis.
Methods
From a registry of 414 patients with borderline negative fractional flow reserve (0.81-0.85), 100 lesions were randomly selected; 3D-QCA and CFD analysis were performed using the conventional approach and the novel (CAAS Workstation WSS) software, and the QCA and WSS estimations of the two approaches were compared. The reproducibility of the two methodologies was evaluated in a subgroup of 50 lesions.
Results
A good agreement was noted between the conventional approach and the novel software for the 3D-QCA metrics (ICC range: 0.73-0-93) and the maximum WSS at the lesion site (ICC: 0.88). Both methodologies had a high reproducibility in assessing lesion severity (ICC range: 0.83-0.97 for the conventional approach; 0.84-0.96 for the CAAS Workstation WSS software) and WSS distribution (ICC: 0.85-0.89 and 0.83-0.87, respectively). Simulation time was significantly shorter using the CAAS Workstation WSS software compared to the conventional approach (4.13 ± 0.59 min vs 23.14 ± 2.56 min, p < 0.001).
Conclusion
CAAS Workstation WSS software is fast, reproducible, and accurate in assessing WSS distribution. Therefore, this software is expected to enable the broad use of WSS metrics in the clinical arena to identify high-risk lesions and vulnerable patients.

Copyright © 2022. Published by Elsevier B.V.

Int J Cardiol: 11 Mar 2022; epub ahead of print
Tufaro V, Torii R, Erdogan E, Kitslaar P, ... Aben JP, Bourantas CV
Int J Cardiol: 11 Mar 2022; epub ahead of print | PMID: 35292271
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Impact:
Abstract

Trends in Arterial Access Site Selection and Bleeding Outcomes Following Coronary Procedures, 2011-2018.

Doll JA, Beaver K, Naranjo D, Waldo SW, ... Helfrich CD, Rao SV
Background
Prior studies of radial access for cardiac catheterization have focused on early adopters of the technique, and some have described a risk/treatment paradox of low radial access use among high bleeding risk patients. This study aimed to determine (1) trends in radial access use over time, (2) if increasing use of radial access is driven by new invasive and interventional cardiologists (operators) or existing operators changing their practice, and (3) if increasing radial rates are associated with lower bleeding rates and elimination of the risk/treatment paradox.
Methods
In this cross-sectional study using data from the Clinical Assessment, Reporting, and Tracking Program, we calculated radial access rates and risk-adjusted postprocedural bleeding rates of patients undergoing diagnostic angiography or percutaneous coronary intervention (PCI) between 2011 and 2018 in Veterans Affairs hospitals. We used separate bleeding risk models for diagnostic angiography and PCI and assessed temporal trends with the Kendall Tau-b test.
Results
Among 253 179 diagnostic angiograms and 93 614 PCIs, radial access rates increased over time for both diagnostic (17.5%-60.4%; P<0.01)) and PCI procedures (14.0%-51.8%; P<0.01). Existing operators and new operators increased their use at similar rates, but new operators entered practice with higher baseline rates. Nearly all operators used radial access at least once in 2018. Overall adjusted rates of bleeding declined, a trend that was significant for diagnostic angiography (2.4%-1.4%, P=0.02) but not PCI (3.4%-2.5%, P=0.20). Femoral access patients had a higher predicted risk for bleeding.
Conclusions
A steady rise in radial access for diagnostic angiography and PCI was driven by increasing use among existing operators and high use by new operators. While this was associated with decreasing bleeding rates, a risk/treatment paradox for access site selection persists; patients at higher bleeding risk were still more likely to receive femoral access.



Circ Cardiovasc Qual Outcomes: 10 Mar 2022:CIRCOUTCOMES121008359; epub ahead of print
Doll JA, Beaver K, Naranjo D, Waldo SW, ... Helfrich CD, Rao SV
Circ Cardiovasc Qual Outcomes: 10 Mar 2022:CIRCOUTCOMES121008359; epub ahead of print | PMID: 35272504
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Impact:
Abstract

Randomized Evaluation of Vessel Preparation With Orbital Atherectomy Prior to Drug-Eluting Stent Implantation in Severely Calcified Coronary Artery Lesions: Design and Rationale of the ECLIPSE Trial.

Généreux P, Kirtane AJ, Kandzari DE, Armstrong EJ, ... O\'Neill WW, Stone GW
Background
Severe coronary artery calcification has been associated with stent underexpansion, procedural complications, and increased rates of early and late adverse clinical events in patients undergoing percutaneous coronary intervention (PCI). To date, no lesion preparation strategy has been shown to definitively improve outcomes of PCI for calcified coronary artery lesions.
Study design and objectives
ECLIPSE (NCT03108456) is a prospective, randomized, multicenter trial designed to evaluate two different vessel preparation strategies in severely calcified coronary artery lesions. The routine use of the Diamondback 360® Coronary Orbital Atherectomy System (OAS) is compared with conventional balloon angioplasty prior to drug-eluting stent implantation. The trial aims to enroll approximately 2000 subjects with a primary clinical endpoint of target vessel failure, defined as the composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target vessel revascularization assessed at 1 year. The co-primary endpoint is the acute post-procedural in-stent minimal cross-sectional area as assessed by optical coherence tomography in a 500-subject cohort. Enrollment is anticipated to complete in 2022 with total clinical follow-up planned for 2 years.
Conclusions
ECLIPSE is a large-scale, prospective randomized trial powered to demonstrate whether a vessel preparation strategy of routine OAS is superior to conventional balloon angioplasty prior to implantation of drug-eluting stents in severely calcified coronary artery lesions.

Copyright © 2022. Published by Elsevier Inc.

Am Heart J: 10 Mar 2022; epub ahead of print
Généreux P, Kirtane AJ, Kandzari DE, Armstrong EJ, ... O'Neill WW, Stone GW
Am Heart J: 10 Mar 2022; epub ahead of print | PMID: 35288105
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Impact:
Abstract

Coronary Artery Ectasia in the Pathophysiology of Myocardial Infarction With Nonobstructive Coronary Arteries.

Eyuboglu M, Eyuboglu C
Coronary artery ectasia (CAE) is associated with an increased risk for acute myocardial infarction (AMI). A significant proportion of patients with AMI have no obstructive coronary artery disease (CAD), however, the underlying mechanism of myocardial infarction with nonobstructive coronary arteries (MINOCA) is poorly understood. Therefore, the present study aimed to investigate whether CAE has a role in the pathogenesis of MINOCA. A total of 1,284 patients who were admitted with a diagnosis of non-ST-segment elevation myocardial infarction were included in the study. Patients were divided into 2 groups according to the presence or absence of obstructive CAD (≥50% stenosis). Patients without obstructive CAD (MINOCA group) and patients with obstructive CAD (no-MINOCA group) were compared regarding the frequency of CAE. Additionally, the association between CAE and MINOCA was investigated. In the study participants, 101 patients (7.9%) were diagnosed with MINOCA, whereas 1,183 (92.1%) had AMI with obstructive CAD. Importantly, the frequency of patients with CAE was significantly higher in patients with MINOCA compared with those with obstructive CAD (22.8% vs 3.5%, p <0.001). Moreover, CAE was observed in 64 patients (4.9%). The frequency of MINOCA was found to be significantly higher in patients with CAE compared with patients without CAE (35.9% vs 6.4%, p <0.001). Furthermore, multivariate analysis demonstrated that the presence of CAE was an independent predictor of MINOCA in patients presented with a diagnosis of non-ST-segment elevation myocardial infarction (odds ratio 1.812, 95% confidence interval 1.376 to 2.581, p <0.001). In conclusion, CAE may be considered as a risk factor for MINOCA and may have a role in the pathophysiology of MINOCA.

Copyright © 2022 Elsevier Inc. All rights reserved.

Am J Cardiol: 10 Mar 2022; epub ahead of print
Eyuboglu M, Eyuboglu C
Am J Cardiol: 10 Mar 2022; epub ahead of print | PMID: 35287947
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Impact:
Abstract

Pacemaker risk following transcatheter aortic valve replacement - A Bayesian reanalysis.

Albuquerque AM, Brophy JM
Objectives
To estimate the probability of increased total mortality risk in patients receiving a cardiac pacemaker following transcatheter aortic valve replacement (TAVR).
Background
A recent publication of a nationwide Swedish, population-based cohort study found no statistically significant difference for all-cause mortality. It is unknown if a Bayesian reanalysis would provide additional insights and lead to the same conclusion.
Methods
A digitalized approach to the published Kaplan - Meier curves was used to reconstruct the individual patient dataset. Bayesian survival analyses of this data using both vague, thereby allowing the posterior probability to be completely dominated by the observed data, as well as skeptical and informative priors, based on the mortality risk of pacemaker implantation following surgical aortic valve replacement, were performed.
Results
The individual patient data set was reliably reconstructed and showed a 4 year follow-up hazard ratio (HR) = 1.08, 95% credible interval (CrI) 0.85-1.36. The Bayesian analysis using a vague prior revealed a 74.9% probability of increased mortality in the pacemaker group. Using a skeptical, semi-informative, and fully informative priors, the posterior probabilities of increased mortality following pacemaker insertion was increased to 68.9%, 93.9% and 98.4%, respectively.
Conclusions
This Bayesian reanalysis suggests a moderate to high probability of an increased total mortality in TAVR patients requiring post procedural pacemaker implantation.

Copyright © 2021. Published by Elsevier B.V.

Int J Cardiol: 09 Mar 2022; epub ahead of print
Albuquerque AM, Brophy JM
Int J Cardiol: 09 Mar 2022; epub ahead of print | PMID: 35283249
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Impact:
Abstract

Rates and impact of vascular complications in mechanical circulatory support.

Lemor A, Dabbagh MF, Cohen D, Villablanca P, ... O\'Neill W, Basir MB
Background
Mechanical circulatory support (MCS) devices are increasingly used for hemodynamic support in cardiogenic shock or high-risk percutaneous coronary interventions. Vascular complications remain a major source of morbidity and mortality despite technological advances with percutaneous techniques. Little is known about the rates and predictors of vascular complications with large-bore access MCS in the contemporary era.
Methods
The study cohort was derived from National Inpatient Sample using data from 2015 to 2019 for cardiac hospitalizations with the use of: intra-aortic balloon pump (IABP) Impella, and/or extracorporeal membrane oxygenation (ECMO). The rates of vascular complications and in-hospital outcomes were analyzed using multivariable logistic regression.
Results
Of 221,700 hospitalizations with MCS use, the majority had only IABP (68%). The rates of vascular complications were greatest with ECMO (15.8%) when compared with IABP (3.0%) and Impella (5.6%). Among patients with vascular complications, in-hospital mortality was higher with ECMO (56.3%) when compared with IABP (26.2%) and Impella (33.8%). Peripheral arterial disease (PAD) was the strongest predictor of vascular complications, with 10 times higher odds when present (adjusted odds ratio [aOR] 10.96, p < 0.001). In risk-adjusted models, when compared with IABP, the use of Impella (aOR: 1.73, p < 0.001), ECMO (aOR: 5.35, p < 0.001), or a combination of MCS devices (aOR: 3.47, p < 0.001) was associated with higher odds of vascular complications.
Conclusions
In contemporary practice, the use of MCS is associated with significant vascular complications and in-hospital mortality. Predictors of vascular complications include larger arteriotomy size, female gender, and peripheral arterial disease. Vascular access management remains essential to prevent major complications.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 08 Mar 2022; epub ahead of print
Lemor A, Dabbagh MF, Cohen D, Villablanca P, ... O'Neill W, Basir MB
Catheter Cardiovasc Interv: 08 Mar 2022; epub ahead of print | PMID: 35266287
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Impact:
Abstract

Supravalvular pulmonary stenosis: A risk factor for reintervention in Noonan syndrome with pulmonary valve stenosis.

Abumehdi M, Mehta C, Afifi ARSA, Yong SF, ... Dhillon R, Stumper O
To assess the short- and long-term outcomes of balloon pulmonary valvuloplasty (BPV) in children with Noonan syndrome (NS). Pulmonary stenosis (PS) is the most common congenital heart lesion in NS. BPV is the accepted first line treatment in PS. However, BPV in NS patients has been reported to be less effective, without specific factors for the need for reintervention being identified. Retrospective case-note review of all patients with NS who underwent BPV between 1985 and 2020. Patients were divided into 2 groups: those with supravalvular pulmonary stenosis (SPS) in addition to valvar PS, and those with isolated valvar PS. A cohort of 54 patients with NS underwent BPV at a median of 275 (interquartile range [IQR]: 108-575) days of age. SPS was present in 32 (59%) patients whereas 22 had (41) isolated PS. The preprocedural invasive gradient was 47 (IQR: 35-69) mmHg, and 44 (IQR: 35-48) mmHg in those with SPS and those without respectively (p = 0.88). Reintervention was required in 22 patients (41%): 17 (77%) -with SPS and 5 (23%) without (p = 0.017). Fourteen patients (11 with SPS) required surgical reintervention and 8 (6 with SPS) required further BPV. There was no significant difference in the age at initial BPV, pre- and postprocedural gradients and interval until reintervention between groups. This is the largest reported cohort of patients with NS undergoing BPV. Although BPV is often successful, the reintervention rates are high. SPS was a risk factor for reintervention.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 08 Mar 2022; epub ahead of print
Abumehdi M, Mehta C, Afifi ARSA, Yong SF, ... Dhillon R, Stumper O
Catheter Cardiovasc Interv: 08 Mar 2022; epub ahead of print | PMID: 35266270
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Impact:
Abstract

Ticagrelor monotherapy versus aspirin monotherapy at 12 months after percutaneous coronary intervention: a landmark analysis of the GLOBAL LEADERS trial.

Ono M, Hara H, Kawashima H, Gao C, ... Onuma Y, Serruys PW
Background
The optimal antiplatelet strategy in the second year after percutaneous coronary intervention (PCI) remains unclear.
Aims
We aimed to compare ticagrelor monotherapy with aspirin monotherapy on clinical outcomes beyond 1 year post-PCI.
Methods
This post hoc subanalysis of the open-label, all-comers, randomised GLOBAL LEADERS trial, which compared 23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT), with 12-month aspirin monotherapy following 12-month DAPT, only included patients who, at 12 months, were free from ischaemic and bleeding events, and adherent to their assigned antiplatelet therapy. The incidences of ischaemic events (all-cause death, any myocardial infarction, or any stroke) and bleeding events (Bleeding Academic Research Consortium [BARC] type 3 or 5 bleeding) during the second year (12-24 months) were compared between patients receiving either ticagrelor or aspirin monotherapy.
Results
The present analysis included 11,121 (ticagrelor monotherapy n=5,308, and aspirin monotherapy n=5,813) of the 15,991 patients enrolled in GLOBAL LEADERS. During the second year, the ischaemic composite endpoint was lower with ticagrelor monotherapy compared to aspirin monotherapy (1.9% vs 2.6%: log-rank p=0.014, adjusted hazard ratio [HR] 0.74, 95% confidence interval [CI]: 0.58-0.96; p=0.022), which was primarily driven by a reduced risk of myocardial infarction. In contrast, BARC type 3 or 5 bleeding was numerically higher with ticagrelor monotherapy (0.5% vs 0.3%: log-rank p=0.051, adjusted HR 1.89, 95% CI: 1.03-3.45; p=0.005).
Conclusions
Patients free from events at the end of the first year post-PCI and who adhered to their prescribed regimen had a reduced risk of ischaemic events compared to aspirin monotherapy in the second year post-PCI.
Clinicaltrials
gov: NCT01813435.



EuroIntervention: 08 Mar 2022; epub ahead of print
Ono M, Hara H, Kawashima H, Gao C, ... Onuma Y, Serruys PW
EuroIntervention: 08 Mar 2022; epub ahead of print | PMID: 35260381
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Impact:
Abstract

Volume-Outcome Relationships for Percutaneous Coronary Intervention in Acute Myocardial Infarction.

Saito Y, Tateishi K, Kanda M, Shiko Y, ... Kobayashi Y, Inoue T

Background:
Lower primary percutaneous coronary intervention (PCI) volume is known to be associated with worse outcomes in patients with acute myocardial infarction (MI) at hospital level. The present study aimed to evaluate the relations of primary, elective, and total PCI volume and primary/total PCI volume ratio per hospital to in-hospital mortality in patients with acute MI undergoing primary PCI. Methods and Results Using a large nationwide administrative database, we included a total of 83 076 patients from 154 hospitals in Japan undergoing PCI for either acute MI or elective cases. Relations of annual procedural volumes for primary, elective, and total PCI to in-hospital mortality after acute MI at hospital level were evaluated. The ratio of primary to total PCI volume per hospital was also assessed. The primary end point was the ratio of observed to predicted mortality. Of 83 076 patients, 26 913 (32.4%) underwent primary PCI for acute MI, among whom 1561 (5.8%) died during hospitalization. Overall, observed in-hospital mortality after acute MI and observed/predicted mortality ratio were higher in hospitals with lower primary, elective, and total PCI volumes. Observed/predicted in-hospital mortality ratio was higher in hospitals with low primary/total PCI volume ratio, even in those with high total PCI volume.
Conclusions:
Primary, elective, and total PCI volume at hospitals were inversely associated with in-hospital mortality in patients with acute MI undergoing primary PCI. Lower ratio of primary to total PCI volume were related to higher in-hospital mortality, suggesting primary/total PCI volume ratio as an institutional indicator of quality of care for acute MI.




J Am Heart Assoc: 08 Mar 2022:e023805; epub ahead of print
Saito Y, Tateishi K, Kanda M, Shiko Y, ... Kobayashi Y, Inoue T
J Am Heart Assoc: 08 Mar 2022:e023805; epub ahead of print | PMID: 35261284
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Impact:
Abstract

Treatment With Icosapent Ethyl to Reduce Ischemic Events in Patients With Prior Percutaneous Coronary Intervention: Insights From REDUCE-IT PCI.

Peterson BE, Bhatt DL, Steg PG, Miller M, ... Ballantyne CM, REDUCE‐IT Investigators

Background:
Patients who undergo percutaneous coronary intervention (PCI) are at increased risk for recurrent cardiovascular events despite aggressive medical therapy. Methods and Results This post hoc analysis focused on the subset of patients with prior PCI enrolled in REDUCE-IT (Reduction of Cardiovascular Events With Icosapent Ethyl-Intervention Trial), a multicenter, randomized, double-blind, placebo-controlled trial of icosapent ethyl versus placebo. Icosapent ethyl was added to statins in patients with low-density lipoprotein cholesterol <100 mg/dL and fasting triglycerides 135-499 mg/dL. The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization. There were 8179 patients randomized in REDUCE-IT followed for a median of 4.9 years, and 3408 (41.7%) of them had a prior PCI with a median follow-up of 4.8 years. These patients were randomized a median of 2.9 years (11 days to 30.7 years) after PCI. Among patients treated with icosapent ethyl versus placebo, there was a 34% reduction in the primary composite end point (hazard ratio [HR], 0.66; 95% CI, 0.58-0.76; P<0.001; number needed to treat4.8 years=12) and a 34% reduction in the key secondary composite end point of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke (HR, 0.66; 95% CI, 0.56-0.79; P<0.001; NNT4.8 years=19) versus placebo. Similarly, large reductions occurred in total coronary revascularizations and revascularization subtypes. There was also a 39% reduction in total events (rate ratio, 0.61; 95% CI, 0.52-0.72; P<0.001).
Conclusions:
Among patients treated with statins with elevated triglycerides and a history of prior PCI, icosapent ethyl substantially reduced the risk of recurrent events during an average of ~5 years of follow-up with a number needed to treat of only 12. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01492361.




J Am Heart Assoc: 08 Mar 2022:e022937; epub ahead of print
Peterson BE, Bhatt DL, Steg PG, Miller M, ... Ballantyne CM, REDUCE‐IT Investigators
J Am Heart Assoc: 08 Mar 2022:e022937; epub ahead of print | PMID: 35261279
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Impact:
Abstract

Very early infective endocarditis after transcatheter aortic valve replacement.

Panagides V, Abdel-Wahab M, Mangner N, Durand E, ... Holzhey D, Rodés-Cabau J
Background
Scarce data exist about early infective endocarditis (IE) after trans-catheter aortic valve replacement (TAVR).
Objective
The objective was to evaluate the characteristics, management, and outcomes of very early (VE) IE (≤ 30 days) after TAVR.
Methods
This multicenter study included a total of 579 patients from the Infectious Endocarditis after TAVR International Registry who had the diagnosis of definite IE following TAVR.
Results
Ninety-one patients (15.7%) had VE-IE. Factors associated with VE-IE (vs. delayed IE (D-IE)) were female gender (p = 0.047), the use of self-expanding valves (p < 0.001), stroke (p = 0.019), and sepsis (p < 0.001) after TAVR. Staphylococcus aureus was the main pathogen among VE-IE patients (35.2% vs. 22.7% in the D-IE group, p = 0.012), and 31.2% of Staphylococcus aureus infections in the VE-IE group were methicillin-resistant (vs. 14.3% in the D-IE group, p = 0.001). The second-most common germ was enterococci (34.1% vs. 24.4% in D-IE cases, p = 0.05). VE-IE was associated with very high in-hospital (44%) and 1-year (54%) mortality rates. Acute renal failure following TAVR (p = 0.001) and the presence of a non-enterococci pathogen (p < 0.001) were associated with an increased risk of death.
Conclusion
A significant proportion of IE episodes following TAVR occurs within a few weeks following the procedure and are associated with dismal outcomes. Some baseline and TAVR procedural factors were associated with VE-IE, and Staphylococcus aureus and enterococci were the main causative pathogens. These results may help to select the more appropriate antibiotic prophylaxis in TAVR procedures and guide the initial antibiotic therapy in those cases with a clinical suspicion of IE. Very early infective endocarditis after trans-catheter aortic valve replacement. VE-IE indicates very early infective endocarditis (≤30 days post TAVR). D-IE indicates delayed infective endocarditis.

© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.

Clin Res Cardiol: 08 Mar 2022; epub ahead of print
Panagides V, Abdel-Wahab M, Mangner N, Durand E, ... Holzhey D, Rodés-Cabau J
Clin Res Cardiol: 08 Mar 2022; epub ahead of print | PMID: 35262756
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Impact:
Abstract

Prasugrel Dose De-escalation Therapy After Complex Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome: A Post Hoc Analysis From the HOST-REDUCE-POLYTECH-ACS Trial.

Hwang D, Lim YH, Park KW, Chun KJ, ... Kim HS, HOST-RP-ACS investigators
Importance
De-escalation of dual-antiplatelet therapy through dose reduction of prasugrel improved net adverse clinical events after acute coronary syndrome (ACS), mainly through the reduction of bleeding without an increase in ischemic outcomes. However, whether such benefits are similarly observed in those receiving complex procedures is unknown.
Objective
To investigate whether the benefits of prasugrel dose de-escalation therapy are maintained in the complex percutaneous coronary intervention (PCI) subgroup.
Design, setting, and participants
This was a post hoc analysis of the HOST-REDUCE-POLYTECH-ACS trial, a randomized, open-label, adjudicator-blinded, multicenter trial performed at 35 hospitals in South Korea. Study participants included patients with ACS who were receiving PCI. Data were collected from September 30, 2014, to December 18, 2015, and analyzed from September 17, 2020, to June 15, 2021.
Interventions and exposures
Patients were randomized to a prasugrel dose de-escalation (5 mg daily) at 1 month post-PCI group or a conventional (10 mg daily) group. Complex PCI was defined as having at least 1 of the following features: 3 or more stents implanted, 3 or more lesions treated, bifurcation PCI, total stent length 60 mm or larger, left main PCI, or heavy calcification.
Main outcomes and measures
The main analysis end points were MACE (major adverse cardiac event, a composite of cardiovascular death, nonfatal myocardial infarction, stent thrombosis, and repeat revascularization) at 1 year for ischemic outcomes, and BARC (Bleeding Academic Research Consortium) class 2 or higher bleeding events at 1 year for bleeding outcomes.
Results
Of 2271 patients (mean [SD] age, 58.9 [9.0] years; 2024 [89%] male patients) for whom full procedural data were available, 705 patients received complex PCI, and 1566 patients received noncomplex PCI. Complex PCI was associated with higher rates of ischemic outcomes but not with bleeding outcomes. Prasugrel dose de-escalation did not increase the risk of MACE (hazard ratio [HR], 0.88; 95% CI, 0.47-1.66; P = .70 in complex PCI; HR, 0.81; 95% CI, 0.45-1.46; P = .48 in noncomplex PCI; P for interaction = .84) but decreased BARC class 2 or higher bleeding events (HR, 0.25; 95% CI, 0.10-0.61; P = .002 in complex PCI; HR, 0.62; 95% CI, 0.38-1.00; P = .05 in noncomplex PCI; P for interaction = .08), albeit with wide 95% CIs.

Conclusions:
and relevance
In this post hoc analysis of patients with ACS, prasugrel dose de-escalation compared with conventional therapy was not associated with an increased risk of ischemic outcomes but may reduce the risk of minor bleeding events at 1 year, irrespective of PCI complexity.
Trial registration
ClinicalTrials.gov Identifier: NCT02193971.



JAMA Cardiol: 08 Mar 2022; epub ahead of print
Hwang D, Lim YH, Park KW, Chun KJ, ... Kim HS, HOST-RP-ACS investigators
JAMA Cardiol: 08 Mar 2022; epub ahead of print | PMID: 35262625
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Impact:
Abstract

Amulet or Watchman Device for Percutaneous Left Atrial Appendage Closure: Primary Results of the SWISS-APERO Randomized Clinical Trial.

Galea R, De Marco F, Meneveau N, Aminian A, ... Räber L, Valgimigli M
Background
No study has so far compared Amulet with the new Watchman FLX in terms of residual left atrial appendage (LAA) patency or clinical outcomes in patients undergoing percutaneous LAA closure.
Methods
In the investigator-initiated SWISS APERO trial (Comparison of Amulet Versus Watchman/FLX Device in Patients Undergoing Left Atrial Appendage Closure), patients undergoing LAA closure were randomly assigned (1:1) open label to receive Amulet or Watchman 2.5 or FLX (Watchman) across 8 European centers. The primary end point was the composite of justified crossover to a nonrandomized device during LAA closure procedure or residual LAA patency detected by cardiac computed tomography angiography (CCTA) at 45 days. The secondary end points included procedural complications, device-related thrombus, peridevice leak at transesophageal echocardiography, and clinical outcomes at 45 days.
Results
Between June 2018 and May 2021, 221 patients were randomly assigned to Amulet (111 [50.2%]) or Watchman (110 [49.8%]), of whom 25 (22.7%) patients included before October 2019 received Watchman 2.5, and 85 (77.3%) patients received Watchman FLX. The primary end point was assessable in 205 (92.8%) patients and occurred in 71 (67.6%) patients receiving Amulet and 70 (70.0%) patients receiving Watchman, respectively (risk ratio, 0.97 [95% CI, 0.80-1.16]; P=0.713). A single justified crossover occurred in a patient with Amulet who fulfilled LAA patency criteria at 45-day CCTA. Major procedure-related complications occurred more frequently in the Amulet group (9.0% versus 2.7%; P=0.047) because of more frequent bleeding (7.2% versus 1.8%). At 45 days, the peridevice leak rate at transesophageal echocardiography was higher with Watchman than with Amulet (27.5% versus 13.7%, P=0.020), albeit none was major (ie, >5 mm), whereas device-related thrombus was detected in 1 (0.9%) patient with Amulet and 3 (3.0%) patients with Watchman at CCTA and in 2 (2.1%) and 5 (5.5%) patients at transesophageal echocardiography, respectively. Clinical outcomes at 45 days did not differ between the groups.
Conclusions
Amulet was not associated with a lower rate of the composite of crossover or residual LAA patency compared with Watchman at 45-day CCTA. Amulet, however, was associated with lower peridevice leak rates at transesophageal echocardiography, higher procedural complications, and similar clinical outcomes at 45 days compared with Watchman. The clinical relevance of CCTA-detected LAA patency requires further investigation.
Registration
URL: https://www.
Clinicaltrials
gov; Unique identifier: NCT03399851.



Circulation: 07 Mar 2022; 145:724-738
Galea R, De Marco F, Meneveau N, Aminian A, ... Räber L, Valgimigli M
Circulation: 07 Mar 2022; 145:724-738 | PMID: 34747186
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Impact:
Abstract

2-Year Outcomes After Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients.

Forrest JK, Deeb GM, Yakubov SJ, Rovin JD, ... Huang J, Reardon MJ
Background
The Evolut Low Risk Trial (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients) showed that transcatheter aortic valve replacement (TAVR) with a supra-annular, self-expanding valve was noninferior to surgery for the primary endpoint of all-cause mortality or disabling stroke at 2 years. This finding was based on a Bayesian analysis performed after 850 patients had reached 1 year of follow-up.
Objectives
The goal of this study was to report the full 2-year clinical and echocardiographic outcomes for patients enrolled in the Evolut Low Risk Trial.
Methods
A total of 1,414 low-surgical risk patients with severe aortic stenosis were randomized to receive TAVR or surgical AVR. An independent clinical events committee adjudicated adverse events, and a central echocardiographic core laboratory assessed hemodynamic endpoints.
Results
An attempted implant was performed in 730 TAVR and 684 surgical patients from March 2016 to May 2019. The Kaplan-Meier rates for the complete 2-year primary endpoint of death or disabling stroke were 4.3% in the TAVR group and 6.3% in the surgery group (P = 0.084). These rates were comparable to the interim Bayesian rates of 5.3% with TAVR and 6.7% with surgery (difference: -1.4%; 95% Bayesian credible interval: -4.9% to 2.1%). All-cause mortality rates were 3.5% vs 4.4% (P = 0.366), and disabling stroke rates were 1.5% vs 2.7% (P = 0.119), respectively. Between years 1 and 2, there was no convergence of the primary outcome curves.
Conclusions
The complete 2-year follow-up from the Evolut Low Risk Trial found that TAVR is noninferior to surgery for the primary endpoint of all-cause mortality or disabling stroke, with event rates that were slightly better than those predicted by using the Bayesian analysis. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients [Evolut Low Risk Trial]; NCT02701283).

Copyright © 2022. Published by Elsevier Inc.

J Am Coll Cardiol: 07 Mar 2022; 79:882-896
Forrest JK, Deeb GM, Yakubov SJ, Rovin JD, ... Huang J, Reardon MJ
J Am Coll Cardiol: 07 Mar 2022; 79:882-896 | PMID: 35241222
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Impact:
Abstract

Trends in Utilization of Aortic Valve Replacement for Severe Aortic Stenosis.

Li SX, Patel NK, Flannery LD, Selberg A, ... Turchin A, Elmariah S
Background
Despite the rapid growth of aortic valve replacement (AVR) for aortic stenosis (AS), limited data suggest symptomatic severe AS remains undertreated.
Objectives
This study sought to investigate temporal trends in AVR utilization among patients with a clinical indication for AVR.
Methods
Patients with severe AS (aortic valve area <1 cm2) on transthoracic echocardiograms from 2000 to 2017 at 2 large academic medical centers were classified based on clinical guideline indications for AVR and divided into 4 AS subgroups: high gradient with normal left ventricular ejection fraction (LVEF) (HG-NEF), high gradient with low LVEF (HG-LEF), low gradient with normal LVEF (LG-NEF), and low gradient with low LVEF (LG-LEF). Utilization of AVR was examined and predictors identified.
Results
Of 10,795 patients, 6,150 (57%) had an indication or potential indication for AVR, of whom 2,977 (48%) received AVR. The frequency of AVR varied by AS subtype with LG groups less likely to receive an AVR (HG-NEF: 70%, HG-LEF: 53%, LG-NEF: 32%, LG-LEF: 38%, P < 0.001). AVR volumes grew over the 18-year study period but were paralleled by comparable growth in the number of patients with an indication for AVR. In patients with a Class I indication, younger age, coronary artery disease, smoking history, higher hematocrit, outpatient index transthoracic echocardiogram, and LVEF ≥0.5 were independently associated with an increased likelihood of receiving an AVR. AVR was associated with improved survival in each AS-subgroup.
Conclusions
Over an 18-year period, the proportion of patients with an indication for AVR who did not receive AVR has remained substantial despite the rapid growth of AVR volumes.

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

J Am Coll Cardiol: 07 Mar 2022; 79:864-877
Li SX, Patel NK, Flannery LD, Selberg A, ... Turchin A, Elmariah S
J Am Coll Cardiol: 07 Mar 2022; 79:864-877 | PMID: 35241220
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Impact:
Abstract

Prognostic Significance of Ventricular Arrhythmias in 13 444 Patients With Acute Coronary Syndrome: A Retrospective Cohort Study Based on Routine Clinical Data (NIHR Health Informatics Collaborative VA-ACS Study).

Sau A, Kaura A, Ahmed A, Patel KHK, ... Mayet J, Ng FS

Background:
A minority of acute coronary syndrome (ACS) cases are associated with ventricular arrhythmias (VA) and/or cardiac arrest (CA). We investigated the effect of VA/CA at the time of ACS on long-term outcomes. Methods and Results We analyzed routine clinical data from 5 National Health Service trusts in the United Kingdom, collected between 2010 and 2017 by the National Institute for Health Research Health Informatics Collaborative. A total of 13 444 patients with ACS, 376 (2.8%) of whom had concurrent VA, survived to hospital discharge and were followed up for a median of 3.42 years. Patients with VA or CA at index presentation had significantly increased risks of subsequent VA during follow-up (VA group: adjusted hazard ratio [HR], 4.15 [95% CI, 2.42-7.09]; CA group: adjusted HR, 2.60 [95% CI, 1.23-5.48]). Patients who suffered a CA in the context of ACS and survived to discharge also had a 36% increase in long-term mortality (adjusted HR, 1.36 [95% CI, 1.04-1.78]), although the concurrent diagnosis of VA alone during ACS did not affect all-cause mortality (adjusted HR, 1.03 [95% CI, 0.80-1.33]).
Conclusions:
Patients who develop VA or CA during ACS who survive to discharge have increased risks of subsequent VA, whereas those who have CA during ACS also have an increase in long-term mortality. These individuals may represent a subgroup at greater risk of subsequent arrhythmic events as a result of intrinsically lower thresholds for developing VA.




J Am Heart Assoc: 07 Mar 2022:e024260; epub ahead of print
Sau A, Kaura A, Ahmed A, Patel KHK, ... Mayet J, Ng FS
J Am Heart Assoc: 07 Mar 2022:e024260; epub ahead of print | PMID: 35258317
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Impact:
Abstract

Association Between Platelet Reactivity and Long-Term Bleeding Complications After Percutaneous Coronary Intervention According to Diabetes Status.

Cavallari I, Patti G, Maddaloni E, Veneziano F, ... Ussia GP, Grigioni F
The relation between diabetes mellitus (DM) and bleeding complications after percutaneous coronary intervention (PCI) is controversial. This study investigates the role of low platelet reactivity (LPR) in the bleeding risk stratification of patients who underwent PCI according to DM status. A total of 472 patients who underwent PCI on aspirin and clopidogrel were included retrospectively. Platelet reactivity was assessed using the VerifyNow P2Y(12) assay. LPR was defined as platelet reactivity unit ≤178. The primary end point was the occurrence of any bleeding at 5 years stratified by DM status and LPR. DM was present in 30.5% of patients. LPR was less frequent in patients with DM (p = 0.077). Overall, 11.9% of patients experienced a bleeding complication at 5 years. The incidence of bleeding did not differ in subjects with and without DM (p = 0.24). LPR had a similar value for stratifying the increased bleeding risk in patients with and without DM (interaction p between DM and LPR 0.69). A stepwise increase in the crude rates of bleeding complications was observed across patients with and without LPR and DM (log-rank p = 0.004), with those affected by both conditions having the highest crude incidence rate. In conclusion, on top of aspirin, approximately 1/3 of patients who underwent PCI on clopidogrel have LPR. Assessment of LPR provides a significant incremental value for predicting bleeding irrespective of DM status. Although the presence of DM per se does not increase the incidence of hemorrhagic complications, the coexistence of DM and LPR identifies the subgroup with the highest bleeding risk.

Copyright © 2022 Elsevier Inc. All rights reserved.

Am J Cardiol: 07 Mar 2022; epub ahead of print
Cavallari I, Patti G, Maddaloni E, Veneziano F, ... Ussia GP, Grigioni F
Am J Cardiol: 07 Mar 2022; epub ahead of print | PMID: 35277255
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Impact:
Abstract

Gender Differences in Patients With Stable Chest Pain.

Sharma SP, Manintveld OC, Budde RPJ, Hirsch A, Lenzen MJ, Galema TW
This study sought to investigate gender differences in clinical presentation, presence, and extent of coronary artery disease (CAD), and all-cause mortality in patients with stable chest pain who underwent coronary computed tomography angiography (CCTA). Patients who visited the fast-track outpatient clinic of the Erasmus Medical Center and underwent CCTA were analyzed. Clinical characteristics of chest pain, CAD on CCTA, coronary artery calcium scores, and survival were collected retrospectively and compared between men and women. Logistic regression was used to identify independent risk factors for the presence of CAD and Cox regression for all-cause mortality. In 1,835 included patients, 966 (52.6%) were female. Men and women were similar in age (55 vs 56 years). Compared with men, women had a lower frequency of typical pain (22.8% vs 31.1%, p <0.001), lower prevalence of significant CAD (22.2% vs 38.1%, p <0.001), and lower coronary artery calcium scores (p <0.001). CAD was more prevalent in men than in women with typical pain (67.4% vs 35.9%, p <0.001) and also with nontypical pain (24.9% vs 18.1%, p = 0.002). After adjustment for baseline characteristic, male sex was associated with all-cause mortality (adjusted hazard ratio 1.87, 95% confidence interval 1.25 to 2.80, p = 0.002). The additional risk of mortality because of CAD was similar between men and women. Stratifying by typical and nontypical pain, women again had a better prognosis. Our study identifies gender-related differences in characteristics, CCTA-findings, and outcomes for women compared with men presenting for CCTA with chest pain. Women have less CAD and a better prognosis than men, the clinical implications of which require further study.

Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.

Am J Cardiol: 07 Mar 2022; epub ahead of print
Sharma SP, Manintveld OC, Budde RPJ, Hirsch A, Lenzen MJ, Galema TW
Am J Cardiol: 07 Mar 2022; epub ahead of print | PMID: 35277254
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Impact:
Abstract

Prevalence of Acute Pulmonary Embolism at Autopsy in Patients With COVID-19.

Zuin M, Engelen MM, Bilato C, Vanassche T, ... Zuliani G, Roncon L
To date, the actual prevalence of acute pulmonary embolism (PE) in patients with SARS-CoV-2 infection remains unknown, as systematic screening for PE is cumbersome. We performed a systematic review and meta-analysis on autoptic data to estimate the prevalence of histopathologic findings of acute PE and its relevance as a cause of death on patients with COVID-19. We searched MEDLINE-PubMed and Scopus to locate all articles published in the English language, up to August 10, 2021, reporting the autoptic prevalence of acute PE and evaluating PE as the underlying cause of death in patients with COVID-19. The pooled prevalence for both outcomes was calculated using a random-effects model and presenting the related 95% confidence interval (CI). Statistical heterogeneity was measured using the Higgins I2 statistic. We analyzed autoptic data of 749 patients with COVID-19 (mean age 63.4 years) included in 14 studies. In 10 studies, based on 526 subjects (mean age 63.8 years), a random-effect model revealed that autoptic acute PE findings were present in 27.5% of cases (95% CI 15.0 to 45.0%, I2 89.9%). Conversely, in 429 COVID-19 subjects (mean age 64.0 years) enrolled in 9 studies, acute PE was the underlying cause of death in 19.9% of cases (95% CI 11.0 to 33.3%, I2 83.3%). Autoptic findings of acute PE in patients with COVID-19 are present in about 30% of subjects, whereas a venous thromboembolic event represents the underlying cause of death in about 1 of 4 patients.

Copyright © 2022 Elsevier Inc. All rights reserved.

Am J Cardiol: 07 Mar 2022; epub ahead of print
Zuin M, Engelen MM, Bilato C, Vanassche T, ... Zuliani G, Roncon L
Am J Cardiol: 07 Mar 2022; epub ahead of print | PMID: 35277253
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Impact:
Abstract

The Gore Cardioform Atrial Septal Defect Occluder: A novel solution to the management of severe hemolysis following transcatheter septal defect closure.

Naimi I, Jones TK, Steinberg Z
Significant hemolysis is a recognized complication of transcatheter high-velocity shunt occlusion using some Amplatzer devices. We describe a case of severe hemolysis following occlusion of an iatrogenic Gerbode defect with an Amplatzer muscular ventricular septal defect occluder successfully managed by transcatheter device removal and reocclusion with a Gore Cardioform Atrial Septal Defect Occluder.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 07 Mar 2022; epub ahead of print
Naimi I, Jones TK, Steinberg Z
Catheter Cardiovasc Interv: 07 Mar 2022; epub ahead of print | PMID: 35253339
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Impact:
Abstract

Dual antithrombotic treatment in chronic coronary syndrome: European Society of Cardiology criteria vs. CHADS-P2A2RC score.

Würtz M, Olesen KKW, Mortensen MB, Eikelboom JW, ... Kristensen SD, Maeng M
Aims
According to the 2019 European Society of Cardiology (ESC) guidelines on chronic coronary syndromes (CCS), adding a P2Y12 inhibitor or rivaroxaban to aspirin should be considered in high-risk patients. We estimated the proportion of patients eligible for treatment with the ESC criteria and examined if a recently validated risk score (CHADS-P2A2RC) could improve risk prediction.
Methods and results
We included 61 338 CCS patients undergoing first-time coronary angiography in Western Denmark (2003-16) and classified them according to the ESC criteria and the CHADS-P2A2RC score. The ESC criteria identified 33.9% as high risk, 53.3% as moderate risk, and 12.8% as low risk. The CHADS-P2A2RC score identified 24.9% as high risk (≥4 points), 48.1% as moderate risk (2-3 points), and 27.0% as low risk (≤1 points). Major adverse cardiovascular events per 100 person-years were 4.8 [95% confidence interval (CI) 4.6-5.0] in patients considered high risk with both schemes, 2.1 (95% CI 2.0-2.2) in patients considered high risk with the ESC but low-to-moderate risk with the CHADS-P2A2RC criteria, 3.8 (95% CI 3.6-4.1) in patients considered low-to-moderate risk with the ESC but high risk with the CHADS-P2A2RC criteria, and 1.5 (95% CI 1.5-1.6) in patients considered low-to-moderate risk with both schemes. The CHADS-P2A2RC score enabled correct downward risk reclassification of 5161 patients (8%) without events, yielding an improved specificity of 9.7%, a loss of sensitivity of 4.4%, and an overall net reclassification index of 0.053.
Conclusion
Based on the 2019 ESC guidelines, dual antithrombotic treatment should be considered in one-third of CCS patients. The CHADS-P2A2RC score improved risk classification and may particularly identify low-risk patients with limited benefit from treatment.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.

Eur Heart J: 06 Mar 2022; 43:996-1004
Würtz M, Olesen KKW, Mortensen MB, Eikelboom JW, ... Kristensen SD, Maeng M
Eur Heart J: 06 Mar 2022; 43:996-1004 | PMID: 34871376
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Impact:
Abstract

Comparative effects of guided vs. potent P2Y12 inhibitor therapy in acute coronary syndrome: a network meta-analysis of 61 898 patients from 15 randomized trials.

Galli M, Benenati S, Franchi F, Rollini F, ... Sibbing D, Angiolillo DJ
Aims
Guidelines recommend the use of potent P2Y12 inhibitors over clopidogrel for the reduction of ischaemic events in patients with acute coronary syndrome (ACS). However, this comes at the expense of increased bleeding. A guided selection of P2Y12 inhibiting therapy has the potential to overcome this limitation. We aimed at evaluating the comparative safety and efficacy of guided vs. routine selection of potent P2Y12 inhibiting therapy in patients with ACS.
Methods and results
We performed a network meta-analysis of randomized controlled trials (RCTs) comparing different oral P2Y12 inhibitors currently recommended for the treatment of patients with ACS (clopidogrel, prasugrel, and ticagrelor). RCTs including a guided approach (i.e. platelet function or genetic testing) vs. standard selection of P2Y12 inhibitors among patients with ACS were also included. Incidence rate ratios (IRR) and associated 95% confidence intervals (CIs) were estimated. P-scores were used to estimate hierarchies of efficacy and safety. The primary efficacy endpoint was major adverse cardiovascular events (MACE) and the primary safety endpoint was all bleeding. A total of 61 898 patients from 15 RCTs were included. Clopidogrel was used as reference treatment. A guided approach was the only strategy associated with reduced MACE (IRR: 0.80, 95% CI: 0.65-0.98) without any significant trade-off in all bleeding (IRR: 1.22, 95% CI: 0.96-1.55). A guided approach and prasugrel were associated with reduced myocardial infarction. A guided approach, prasugrel, and ticagrelor were associated with reduced stent thrombosis. Ticagrelor was also associated with reduced total and cardiovascular mortality. Prasugrel was associated with increased major bleeding. Prasugrel and ticagrelor were associated with increased minor bleeding. The incidence of stroke did not differ between treatments.
Conclusion
In patients with an ACS, compared with routine selection of potent P2Y12 inhibiting therapy (prasugrel or ticagrelor), a guided selection of P2Y12 inhibiting therapy is associated with the most favourable balance between safety and efficacy. These findings support a broader adoption of guided approach for the selection of P2Y12 inhibiting therapy in patients with ACS.
Study registration number
This study is registered in PROSPERO (CRD42021258603).
Key question
A guided selection of P2Y12 inhibiting therapy using platelet function or genetic testing improves outcomes among patients undergoing percutaneous coronary intervention. Nevertheless, the comparative safety and efficacy of a guided versus routine selection of potent P2Y12-inhibiting therapy in acute coronary syndrome has not been explored.
Key finding
In a comprehensive network meta-analysis including the totality of available evidence and using clopidogrel as treatment reference, a guided approach was the only strategy associated with reduced major adverse cardiovascular events without any significant trade-off in bleeding. Prasugrel and ticagrelor increased bleeding and only ticagrelor reduced mortality.
Take home message
A guided selection of P2Y12-inhibiting therapy represents the strategy associated with the most favourable balance between safety and efficacy. These findings support a broader adoption of guided P2Y12 inhibiting therapy in patients with acute coronary syndrome.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.

Eur Heart J: 06 Mar 2022; 43:959-967
Galli M, Benenati S, Franchi F, Rollini F, ... Sibbing D, Angiolillo DJ
Eur Heart J: 06 Mar 2022; 43:959-967 | PMID: 34918066
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Impact:
Abstract

Assessment of arterial stiffness to predict blood pressure response to renal sympathetic denervation.

Fengler K, Rommel KP, Kriese W, Kresoja KP, ... Thiele H, Lurz P
Background
Recent trials support the efficacy of renal sympathetic denervation (RDN) to reduce blood pressure (BP). Nevertheless, about one third of patients are considered non-responders to RDN. Previous retrospective analyses suggest arterial stiffness could predict BP response to RDN.
Aims
We prospectively assessed the potential of invasive pulse wave velocity (iPWV) to predict BP response to RDN. Additionally, we aimed to establish non-invasive models based on arterial stiffness to predict BP response to RDN.
Methods
IPWV, magnetic resonance imaging-based markers of arterial stiffness and the carotid-femoral pulse wave velocity were recorded prior to RDN in patients with treatment resistant hypertension. Changes in daytime BP after 3 months were analysed according to the prespecified iPWV cut-off (14.4 m/s). Regression analyses were used to establish models for non-invasive prediction of BP response. Results were compared to iPWV as reference and were then validated in an external patient cohort.
Results
Eighty patients underwent stiffness assessment before RDN. After 3 months, systolic 24h and daytime BP were reduced by 13.6±9.8 mmHg and 14.7±10.6 mmHg in patients with low iPWV, versus 6.2±13.3 mmHg and 6.3±12.8 mmHg in those with high iPWV (p<0.001 for both). Upon regression analysis, logarithmic ascending aortic distensibility and systolic baseline BP independently predicted BP change at follow-up. Both were confirmed in the validation cohort.
Conclusions
IPWV is an independent predictor for BP response after RDN. In addition, BP change prediction following RDN using non-invasive measures is feasible. This could facilitate patient selection for RDN treatment.



EuroIntervention: 06 Mar 2022; epub ahead of print
Fengler K, Rommel KP, Kriese W, Kresoja KP, ... Thiele H, Lurz P
EuroIntervention: 06 Mar 2022; epub ahead of print | PMID: 35244604
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Impact:
Abstract

Laser vaporization of atherothrombotic burden before drug-coated balloon application in ST-segment elevation myocardial infarction: Two-year outcomes of the laser-DCB trial.

Tonomura D, Shimada Y, Yamanaka Y, Terashita K, ... Tsuchida T, Fukumoto H
Objectives
This study aimed to examine whether the combination of excimer laser coronary atherectomy (ELCA) and drug-coated balloon (DCB) angioplasty can provide feasible clinical outcome in patients with ST-segment elevation myocardial infarction (STEMI) with 8-month and 2-year scheduled follow-up angiography.
Background
Intracoronary thrombus elevates the risk of interventional treatment in patients with STEMI and hampers drug absorption into the vasculature released from DCB.
Methods
Sixty-two patients with STEMI within 24 h after the onset of symptoms were enrolled in this prospective, single-center, single-arm study.
Results
The laser catheter was successfully crossed distal to the culprit lesion in all cases. No ELCA-related adverse events occurred. Bail-out stenting was required in two patients (3.2%) after adjunctive ballooning; thus, the remaining 60 patients were completed with DCB angioplasty without stenting. Scheduled angiography at 8 months and 2 years was completed in 100% and 85.2%, respectively, and minimal lumen diameters were 3.4 ± 0.5, 3.4 ± 0.6, and 3.4 ± 0.5 mm after the procedure, at 8 months and at 2 years, respectively. Binary restenosis was observed in five patients (8.1%) in whom target lesion revascularization was performed. The duration of dual antiplatelet therapy was 2.3 ± 2.2 months, and neither abrupt vessel closure, reinfarction, cardiac death nor major bleeding was observed.
Conclusion
A combination of DCB angioplasty with ELCA is a feasible therapeutic option for STEMI.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 06 Mar 2022; epub ahead of print
Tonomura D, Shimada Y, Yamanaka Y, Terashita K, ... Tsuchida T, Fukumoto H
Catheter Cardiovasc Interv: 06 Mar 2022; epub ahead of print | PMID: 35253349
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Abstract

Individual patient data meta-analysis of patients treated with a heparin-bonded Viabahn in the femoropopliteal artery for chronic limb-threatening ischemia.

Groot Jebbink E, van Wijck I, Holewijn S, Iida O, ... Bosiers M, Reijnen MMPJ
Objectives
The aim of the study was to analyze available data on patients treated for chronic limb-threatening ischemia (CLTI) with the heparin-bonded Viabahn endoprosthesis.
Background
The patency of self-expanding covered stents in patients with complex femoropopliteal lesions is encouraging. However, data were mostly derived in patients with intermittent claudication. Patients with CLTI often have more advanced disease and worse outcome.
Methods
After the abstract screening, full-text papers were checked. Authors were approached to consider joining the consortium. Data were sent anonymously, databases were merged and an individual patient data meta-analysis was performed. Kaplan-Meier curves were used to calculate the freedom from amputations, the amputation-free survival, and patency rates.
Results
Seven studies were enrolled, representing 161 limbs that were treated for CLTI. Median lesion length was 28.0 cm (interquartile range 25.0-33.0 cm) and 82.7% were chronic total occlusions. The technical success rate was 98.1% and the 30-day mortality 1.9%. Through 2-year follow-up, the freedom-from-major-amputations was 99.3%, with an amputation-free survival of 78.8%. The freedom-from-loss-of primary, primary-assisted, and secondary patency was 70.4%, 71.8%, and 88.2%, respectively, at 1-year and 59.5%, 62.7%, and 86.1% at 2-year follow-up, respectively. The reintervention-free survival was 62.2% at a 2-year follow-up.
Conclusions
Treatment of femoropopliteal disease in CLTI patients with the use of the heparin-bonded Viabahn is safe and effective with favorable clinical outcomes and low amputation rates. Reinterventions are needed in a subset of the population to maintain endoprosthesis patency. Close follow-up using duplex is recommended to detect potential edge stenosis, allowing treatment before device occlusion.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 06 Mar 2022; epub ahead of print
Groot Jebbink E, van Wijck I, Holewijn S, Iida O, ... Bosiers M, Reijnen MMPJ
Catheter Cardiovasc Interv: 06 Mar 2022; epub ahead of print | PMID: 35253348
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Abstract

Impact of severity of baseline thrombocytopenia on outcomes after percutaneous coronary interventions: Analysis from the Veterans Affairs Clinical Assessment, Reporting, and Tracking (VA CART) Program.

Vallurupalli S, Hess E, Plomondon ME, Park K, ... Agarwal S, Uretsky BF
Objectives
The aim of this study was to evaluate the effect of the degree of severity of baseline thrombocytopenia (TCP) on outcomes after percutaneous coronary intervention (PCI) BACKGROUND: The association of TCP with clinical outcomes among patients undergoing coronary intervention has not been previously evaluated.
Methods
Using data from the US Veterans Affairs Clinical Assessment, Reporting, and Tracking (CART) Program, we identified patients undergoing PCI between October 1, 2007, to September 30, 2017. The cohort was then stratified by platelet count, as no TCP (platelet count >150,000/mcl), mild TCP (100-150,000/mcl), or moderate-severe TCP (<100,000/mcl) and this was associated with clinical outcomes.
Results
The cohort included 80,427 patients (98% male), of which 14.9% (13.2% mild, 1.7% moderate-severe) suffered from TCP at the time of PCI. Compared with mild or no TCP, moderate-severe TCP was associated with increased risk of post-PCI pericardiocentesis (0.6% vs. 0.2% vs. 0.2%, p = 0.018) and in-hospital mortality (1.5% vs. 0.7% vs. 0.7%) without a difference in postprocedure stroke (0.5% vs. 0.3% vs. 0.3%, p = 0.6). Over a median follow-up of 1729 days, time-to-repeat revascularization was significantly shorter in moderate-severe TCP (1080 vs. 1347 vs. 1467 days, p < 0.001) despite lower risk of revascularization. Both mild (adjusted HR: 1.11, 95% CI: 1.07-1.15, p < 0.001) and moderate-severe TCP (HR: 1.55, 95% CI: 1.43-1.69, p < 0.001) were associated with increased all-cause mortality compared with those without TCP.
Conclusions
Thrombocytopenia was associated with increased short- and long-term adverse events among patients undergoing PCI. Any degree of TCP was associated with increased long-term all-cause mortality while moderate-severe TCP was also associated with increased risk of periprocedural adverse events.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 06 Mar 2022; epub ahead of print
Vallurupalli S, Hess E, Plomondon ME, Park K, ... Agarwal S, Uretsky BF
Catheter Cardiovasc Interv: 06 Mar 2022; epub ahead of print | PMID: 35253342
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Abstract

Relation of Community-Level Socioeconomic Status to Delayed Diagnosis of Acute Type A Aortic Dissection.

Lim B, Chauhan D, Schultz ML, Levine D, ... Forest SJ, DeRose JJ
Acute type A aortic dissection requires timely diagnosis and intervention. Previous studies have examined risk factors associated with delayed diagnosis; however, the effect of socioeconomic status (SES) has not been previously studied. Our study examined the impact of various SES measures on time to diagnosis. We examined time to diagnosis in consecutive cases of acute type A aortic dissection at a single institution. SES variables included race/ethnicity, Medicaid eligibility, and residence in a zip code with an increased Distressed Communities Index-an aggregate measure of community SES. Delayed diagnosis was defined as time to diagnosis in the upper quartile of the study population (>6.6 hours). A model predicting risk factors for delayed diagnosis was created using multivariable logistic regression. Our study included 124 patients with a median time to diagnosis of 3.36 hours (interquartile range [IQR] 1.83 to 6.63). A total of 92 patients were in the nondelayed cohort (median diagnosis time of 2.59 hours, IQR 1.49 to 4.18) and 32 patients were in the delayed cohort (median diagnosis time of 15.57 hours, IQR 9.34 to 28.75). In multivariable logistic regression, residence in a high-Distressed Communities Index zip code was associated with diagnostic delay (adjusted odds ratio [aOR] 5.108, p = 0.008). Patient age (aOR 0.944, p = 0.011), chest pain at presentation (aOR 0.099, p = 0.004), back pain at presentation (aOR 0.247, p = 0.012), evidence of malperfusion syndrome (aOR 0.040, p <0.001), history of hyperlipidemia (aOR 3.507, p = 0.026), and history of congestive heart failure (aOR 0.061, p = 0.036) were also significantly associated. In conclusion, our findings suggest community-level SES affects time to diagnosis in acute type A aortic dissection.

Copyright © 2022 Elsevier Inc. All rights reserved.

Am J Cardiol: 04 Mar 2022; epub ahead of print
Lim B, Chauhan D, Schultz ML, Levine D, ... Forest SJ, DeRose JJ
Am J Cardiol: 04 Mar 2022; epub ahead of print | PMID: 35260240
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Abstract

CT or Invasive Coronary Angiography in Stable Chest Pain.

Maurovich-Horvat P, Bosserdt M, Kofoed KF, Rieckmann N, ... Martus P, Dewey M
Background
In the diagnosis of obstructive coronary artery disease (CAD), computed tomography (CT) is an accurate, noninvasive alternative to invasive coronary angiography (ICA). However, the comparative effectiveness of CT and ICA in the management of CAD to reduce the frequency of major adverse cardiovascular events is uncertain.
Methods
We conducted a pragmatic, randomized trial comparing CT with ICA as initial diagnostic imaging strategies for guiding the treatment of patients with stable chest pain who had an intermediate pretest probability of obstructive CAD and were referred for ICA at one of 26 European centers. The primary outcome was major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) over 3.5 years. Key secondary outcomes were procedure-related complications and angina pectoris.
Results
Among 3561 patients (56.2% of whom were women), follow-up was complete for 3523 (98.9%). Major adverse cardiovascular events occurred in 38 of 1808 patients (2.1%) in the CT group and in 52 of 1753 (3.0%) in the ICA group (hazard ratio, 0.70; 95% confidence interval [CI], 0.46 to 1.07; P = 0.10). Major procedure-related complications occurred in 9 patients (0.5%) in the CT group and in 33 (1.9%) in the ICA group (hazard ratio, 0.26; 95% CI, 0.13 to 0.55). Angina during the final 4 weeks of follow-up was reported in 8.8% of the patients in the CT group and in 7.5% of those in the ICA group (odds ratio, 1.17; 95% CI, 0.92 to 1.48).
Conclusions
Among patients referred for ICA because of stable chest pain and intermediate pretest probability of CAD, the risk of major adverse cardiovascular events was similar in the CT group and the ICA group. The frequency of major procedure-related complications was lower with an initial CT strategy. (Funded by the European Union Seventh Framework Program and others; DISCHARGE ClinicalTrials.gov number, NCT02400229.).

Copyright © 2022 Massachusetts Medical Society.

N Engl J Med: 03 Mar 2022; epub ahead of print
Maurovich-Horvat P, Bosserdt M, Kofoed KF, Rieckmann N, ... Martus P, Dewey M
N Engl J Med: 03 Mar 2022; epub ahead of print | PMID: 35240010
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Abstract

Delayed administration of epinephrine is associated with worse neurological outcomes in patients with out-of-hospital cardiac arrest and initial pulseless electrical activity: insight from the nationwide multicentre observational JAAM-OHCA (Japan Association for Acute Medicine) registry.

Enzan N, Hiasa KI, Ichimura K, Nishihara M, ... Kitazono T, Tsutsui H
Aims
The delayed administration of epinephrine has been proven to worsen the neurological outcomes of patients with out-of-hospital cardiac arrest (OHCA) and shockable rhythm or asystole. We aimed to investigate whether the delayed administration of epinephrine might also worsen the neurological outcomes of patients with witnessed OHCA and initial pulseless electrical activity (PEA).
Methods and results
The JAAM-OHCA Registry is a multicentre registry including OHCA patients between 2014 and 2017. Patients with emergency medical services (EMS)-treated OHCA and initial PEA rhythm were included. The primary exposure was the time from the EMS call to the administration of epinephrine. The secondary exposure was the time to epinephrine dichotomized as early (≤15 min) or delayed (>15 min). The primary outcome was the achievement of a favourable neurological outcome, defined as Cerebral Performance Categories Scale 1-2 at 30 days after OHCA. Out of 34 754 patients with OHCA, 3050 patients were included in the present study. After adjusting for potential confounders, the delayed administration of the epinephrine was associated with a lower likelihood of achieving a favourable neurological outcome [adjusted odds ratio (OR) 0.96; 95% confidence interval (CI) 0.93-0.99; P = 0.016]. The percentage of patients who achieved a favourable neurological outcome in the delayed epinephrine group was lower than that in the early epinephrine group (1.3% vs. 4.7%; adjusted OR 0.33; 95% CI 0.15-0.72; P = 0.005). A restricted cubic spline analysis demonstrated that delayed epinephrine administration could decrease the likelihood of achieving a favourable neurological outcome; this was significant within the first 10 min.
Conclusions
The delayed administration of epinephrine was associated with worse neurological outcomes in patients with witnessed OHCA patients with initial PEA.

© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.

Eur Heart J Acute Cardiovasc Care: 02 Mar 2022; epub ahead of print
Enzan N, Hiasa KI, Ichimura K, Nishihara M, ... Kitazono T, Tsutsui H
Eur Heart J Acute Cardiovasc Care: 02 Mar 2022; epub ahead of print | PMID: 35238895
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Abstract

Not all pseudoaneurysms are femoral-A transcaval transcatheter aortic valve replacement rare complication.

Mano TB, Ramos R, Cacela D, Patrício L
We report a case of a 73-year-old male with multiple comorbidities, including postpoliomyelitis severe scoliosis, referred to our tertiary center due to a severe symptomatic aortic stenosis, considered high risk for surgical aortic valve replacement (AVR). Due to unsuitable femoral and subclavian accesses, the patient underwent a transcaval transcatheter AVR (TAVR) procedure, complicated by the development of an iatrogenic infrarenal aortic pseudoaneurysm with aortocaval fistula. Scoliosis can cause varying anatomic relationships between retroperitoneal vessels and intervertebral disk spaces, which increase the difficulty of the procedure and consequently lead to this vascular complication. Although most aortocaval fistulas close spontaneously after 1 year, the risk of pseudoaneurysm rupture in this critical area was crucial in the decision of a new successful percutaneous aortic stent intervention.

© 2022 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 02 Mar 2022; epub ahead of print
Mano TB, Ramos R, Cacela D, Patrício L
Catheter Cardiovasc Interv: 02 Mar 2022; epub ahead of print | PMID: 35238470
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