Eight-year outcomes for patients with aortic valve stenosis at low surgical risk randomized to transcatheter vs. surgical aortic valve replacement.

Jørgensen TH, Thyregod HGH, Ihlemann N, Nissen H, ... Olsen PS, Søndergaard L
Aims
The aims of the study were to compare clinical outcomes and valve durability after 8 years of follow-up in patients with symptomatic severe aortic valve stenosis at low surgical risk treated with either transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR).
Methods and results
In the NOTION trial, patients with symptomatic severe aortic valve stenosis were randomized to TAVI or SAVR. Clinical status, echocardiography, structural valve deterioration, and failure were assessed using standardized definitions. In total, 280 patients were randomized to TAVI (n = 145) or SAVR (n = 135). Baseline characteristics were similar, including mean age of 79.1 ± 4.8 years and a mean STS score of 3.0 ± 1.7%. At 8-year follow-up, the estimated risk of the composite outcome of all-cause mortality, stroke, or myocardial infarction was 54.5% after TAVI and 54.8% after SAVR (P = 0.94). The estimated risks for all-cause mortality (51.8% vs. 52.6%; P = 0.90), stroke (8.3% vs. 9.1%; P = 0.90), or myocardial infarction (6.2% vs. 3.8%; P = 0.33) were similar after TAVI and SAVR. The risk of structural valve deterioration was lower after TAVI than after SAVR (13.9% vs. 28.3%; P = 0.0017), whereas the risk of bioprosthetic valve failure was similar (8.7% vs. 10.5%; P = 0.61).
Conclusions
In patients with severe aortic valve stenosis at low surgical risk randomized to TAVI or SAVR, there were no significant differences in the risk for all-cause mortality, stroke, or myocardial infarction, as well as the risk of bioprosthetic valve failure after 8 years of follow-up.
Clinical trial registration
URL: http://www.ClinicalTrials.gov. Unique identifier: NCT01057173.

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

Eur Heart J: 27 Jun 2021; epub ahead of print

HIV infection is associated with thoracic and abdominal aortic aneurysms: a prospective matched cohort study.

Høgh J, Pham MHC, Knudsen AD, Thudium RF, ... Kofoed KF, Nielsen SD
Aims
Little is known about the prevalence of aortic aneurysms among people living with HIV (PLWH). We investigated whether HIV status is independently associated with having aortic aneurysms. Furthermore, we determined risk factors associated with aortic aneurysms in PLWH.
Methods and results
PLWH aged ≥40 years (n = 594) were recruited from the Copenhagen Comorbidity in HIV Infection study and matched for age and sex with uninfected controls (n = 1188) from the Copenhagen General Population Study. Aortic dimensions were assessed using contrast enhanced computed tomography. Aortic aneurysms were defined according to the European Society of Cardiology guidelines, i.e. an aortic dilation of ≥50% or an infrarenal aortic diameter of ≥30 mm. Among PLWH and uninfected controls, the median (interquartile range) age was 52 (47-60) and 52 (48-61) and 88% and 90% were male, respectively. We found 46 aneurysms in 42 (7.1%) PLWH and 31 aneurysms in 29 (2.4%) uninfected controls (P < 0.001). PLWH had a significantly higher prevalence of ascending aortic aneurysms and infrarenal aortic aneurysms. In an adjusted model, HIV was independently associated with aortic aneurysms (adjusted odds ratio; 4.51 [95% confidence interval 2.56-8.08], P < 0.001). Within PLWH, obesity and hepatitis B co-infection were associated with aortic aneurysms.
Conclusion
PLWH had four-fold higher odds of aortic aneurysms compared to uninfected controls, and HIV status was independently associated with aortic aneurysms. Among PLWH, age, obesity and hepatitis B co-infection were associated with higher odds of aortic aneurysms. Our findings suggest that increased attention to aortic aneurysms in PLWH may be beneficial.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: [email protected]

Eur Heart J: 07 Jul 2021; epub ahead of print

Impact of Optimal Medical Therapy on 10-Year Mortality After Coronary Revascularization.

Kawashima H, Serruys PW, Ono M, Hara H, ... Onuma Y, SYNTAX Extended Survival Investigators
Background
The benefit of optimal medical therapy (OMT) on 5-year outcomes in patients with 3-vessel disease and/or left main disease after percutaneous coronary intervention or coronary artery bypass grafting (CABG) was demonstrated in the randomized SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) trial.
Objectives
The objective of this analysis is to assess the impact of the status of OMT at 5 years on 10-year mortality after percutaneous coronary intervention or CABG.
Methods
This is a subanalysis of the SYNTAXES (Synergy Between PCI With Taxus and Cardiac Surgery Extended Survival) study, which evaluated for up to 10 years the vital status of patients who were originally enrolled in the SYNTAX trial. OMT was defined as the combination of 4 types of medications: at least 1 antiplatelet drug, statin, angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, and beta-blocker. After stratifying participants by the number of individual OMT agents at 5 years and randomized treatment, a landmark analysis was conducted to assess the association between treatment response and 10-year mortality.
Results
In 1,472 patients, patients on OMT at 5 years had a significantly lower mortality at 10 years compared with those on ≤2 types of medications (13.1% vs 19.9%; adjusted HR: 0.470; 95% CI: 0.292-0.757; P = 0.002) but had a mortality similar to those on 3 types of medications. Furthermore, patients undergoing CABG with the individual OMT agents, antiplatelet drug and statin, at 5 years had lower 10-year mortality than those without.
Conclusions
In patients with 3-vessel and/or left main disease undergoing percutaneous coronary intervention or CABG, medication status at 5 years had a significant impact on 10-year mortality. Patients on OMT with guideline-recommended pharmacologic therapy at 5 years had a survival benefit. (Synergy Between PCI With Taxus and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES]; NCT03417050; Taxus Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX]; NCT00114972).

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

J Am Coll Cardiol: 05 Jul 2021; 78:27-38

Immediate post-procedural functional assessment of percutaneous coronary intervention: current evidence and future directions.

Ding D, Huang J, Westra J, Cohen DJ, ... Tu S, Wijns W
Percutaneous coronary intervention (PCI) guided by coronary physiology provides symptomatic benefit and improves patient outcomes. Nevertheless, over one-fourth of patients still experience recurrent angina or major adverse cardiac events following the index procedure. Coronary angiography, the current workhorse for evaluating PCI efficacy, has limited ability to identify suboptimal PCI results. Accumulating evidence supports the usefulness of immediate post-procedural functional assessment. This review discusses the incidence and possible mechanisms behind a suboptimal physiology immediately after PCI. Furthermore, we summarize the current evidence base supporting the usefulness of immediate post-PCI functional assessment for evaluating PCI effectiveness, guiding PCI optimization, and predicting clinical outcomes. Multiple observational studies and post hoc analyses of datasets from randomized trials demonstrated that higher post-PCI functional results are associated with better clinical outcomes as well as a reduced rate of residual angina and repeat revascularization. As such, post-PCI functional assessment is anticipated to impact patient management, secondary prevention, and resource utilization. Pre-PCI physiological guidance has been shown to improve clinical outcomes and reduce health care costs. Whether similar benefits can be achieved using post-PCI physiological assessment requires evaluation in randomized clinical outcome trials.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: [email protected]

Eur Heart J: 14 Jul 2021; 42:2695-2707

The Coronary Artery Risk Development In Young Adults (CARDIA) Study: JACC Focus Seminar 8/8.

Lloyd-Jones DM, Lewis CE, Schreiner PJ, Shikany JM, Sidney S, Reis JP
The CARDIA (Coronary Artery Risk Development in Young Adults) study began in 1985 to 1986 with enrollment of 5,115 Black or White men and women ages 18 to 30 years from 4 US communities. Over 35 years, CARDIA has contributed fundamentally to our understanding of the contemporary epidemiology and life course of cardiovascular health and disease, as well as pulmonary, renal, neurological, and other manifestations of aging. CARDIA has established associations between the neighborhood environment and the evolution of lifestyle behaviors with biological risk factors, subclinical disease, and early clinical events. CARDIA has also identified the nature and major determinants of Black-White differences in the development of cardiovascular risk. CARDIA will continue to be a unique resource for understanding determinants, mechanisms, and outcomes of cardiovascular health and disease across the life course, leveraging ongoing pan-omics work from genomics to metabolomics that will define mechanistic pathways involved in cardiometabolic aging.

Copyright © 2021 American College of Cardiology Foundation. All rights reserved.

J Am Coll Cardiol: 19 Jul 2021; 78:260-277

Fractional flow reserve derived from computed tomography coronary angiography in the assessment and management of stable chest pain: the FORECAST randomized trial.

Curzen N, Nicholas Z, Stuart B, Wilding S, ... Hlatky MA, FORECAST Investigators
Aims 
Fractional flow reserve (FFRCT) using computed tomography coronary angiography (CTCA) determines both the presence of coronary artery disease and vessel-specific ischaemia. We tested whether an evaluation strategy based on FFRCT would improve economic and clinical outcomes compared with standard care.
Methods and results 
Overall, 1400 patients with stable chest pain in 11 centres were randomized to initial testing with CTCA with selective FFRCT (experimental group) or standard clinical care pathways (standard group). The primary endpoint was total cardiac costs at 9 months; secondary endpoints were angina status, quality of life, major adverse cardiac and cerebrovascular events, and use of invasive coronary angiography. Randomized patients were similar at baseline. Most patients had an initial CTCA: 439 (63%) in the standard group vs. 674 (96%) in the experimental group, 254 of whom (38%) underwent FFRCT. Mean total cardiac costs were higher by £114 (+8%) in the experimental group, with a 95% confidence interval from -£112 (-8%) to +£337 (+23%), though the difference was not significant (P = 0.10). Major adverse cardiac and cerebrovascular events did not differ significantly (10.2% in the experimental group vs. 10.6% in the standard group) and angina and quality of life improved to a similar degree over follow-up in both randomized groups. Invasive angiography was reduced significantly in the experimental group (19% vs. 25%, P = 0.01).
Conclusion 
A strategy of CTCA with selective FFRCT in patients with stable angina did not differ significantly from standard clinical care pathways in cost or clinical outcomes, but did reduce the use of invasive coronary angiography.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: [email protected]

Eur Heart J: 15 Jul 2021; epub ahead of print

Long-term mortality in patients with ischaemic heart failure revascularized with coronary artery bypass grafting or percutaneous coronary intervention: insights from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR).

Völz S, Redfors B, Angerås O, Ioanes D, ... Jeppsson A, Omerovic E
Aims 
To compare coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) for treatment of patients with heart failure due to ischaemic heart disease.
Methods and results 
We analysed all-cause mortality following CABG or PCI in patients with heart failure with reduced ejection fraction and multivessel disease (coronary artery stenosis >50% in ≥2 vessels or left main) who underwent coronary angiography between 2000 and 2018 in Sweden. We used a propensity score-adjusted logistic and Cox proportional-hazards regressions and instrumental variable model to adjust for known and unknown confounders. Multilevel modelling was used to adjust for the clustering of observations in a hierarchical database. In total, 2509 patients (82.9% men) were included; 35.8% had diabetes and 34.7% had a previous myocardial infarction. The mean age was 68.1 ± 9.4 years (47.8% were >70 years old), and 64.9% had three-vessel or left main disease. Primary designated therapy was PCI in 56.2% and CABG in 43.8%. Median follow-up time was 3.9 years (range 1 day to 10 years). There were 1010 deaths. Risk of death was lower after CABG than after PCI [odds ratio (OR) 0.62; 95% confidence interval (CI) 0.41-0.96; P = 0.031]. The risk of death increased linearly with quintiles of hospitals in which PCI was the preferred method for revascularization (OR 1.27, 95% CI 1.17-1.38, Ptrend < 0.001).
Conclusion 
In patients with ischaemic heart failure, long-term survival was greater after CABG than after PCI.

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

Eur Heart J: 14 Jul 2021; 42:2657-2664

De-Escalation of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndromes.

Shoji S, Kuno T, Fujisaki T, Takagi H, ... Latib A, Kohsaka S
Background
Balancing the effects of dual antiplatelet therapy (DAPT) in the era of potent P2Y₁₂ inhibitors has become a cornerstone of acute coronary syndrome (ACS) management. Recent randomized controlled trials (RCTs) have investigated DAPT de-escalation to decrease the risk of bleeding outcomes.
Objectives
The aim of this study was to compare the efficacy and safety outcomes of various DAPT strategies in patients with ACS, including de-escalation from a potent P2Y₁₂ inhibitor to clopidogrel or low-dose prasugrel.
Methods
MEDLINE and EMBASE were searched through January 2021 for RCTs investigating the efficacy and safety of DAPT in patients with ACS, and a network meta-analysis was conducted. The primary efficacy outcome was a composite of cardiovascular death, myocardial infarction, and stroke. The primary bleeding outcome was trial-defined major or minor bleeding.
Results
Our search identified 15 eligible RCTs, including 55,798 patients with ACS. De-escalation therapy was associated with reduced risk of primary bleeding outcomes (HR: 0.48 [95% CI: 0.30-0.77] vs clopidogrel; HR: 0.32 [95% CI: 0.20-0.52] vs ticagrelor; HR: 0.36 [95% CI: 0.24-0.55] vs standard-dose prasugrel; and HR: 0.40 [95% CI: 0.22-0.75] vs low-dose prasugrel) without negatively affecting primary efficacy outcomes. There were no significant differences in ischemic or bleeding outcomes between de-escalation to clopidogrel or low-dose prasugrel.
Conclusions
Compared with other established uses of DAPT, de-escalation was the most effective strategy for ACS treatment, resulting in fewer bleeding events without increasing ischemic events.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

J Am Coll Cardiol: 08 Jul 2021; epub ahead of print

Transesophageal Echocardiography in Patients Undergoing Coronary Artery Bypass Graft Surgery.

Metkus TS, Thibault D, Grant MC, Badhwar V, ... Zwischenberger B, Higgins R
Background
The impact of utilization of intraoperative transesophageal echocardiography (TEE) at the time of isolated coronary artery bypass grafting (CABG) on clinical decision making and associated outcomes is not well understood.
Objectives
The purpose of this study was to determine the association of TEE with post-CABG mortality and changes to the operative plan.
Methods
A retrospective cohort study of planned isolated CABG patients from the Society of Thoracic Surgeons Adult Cardiac Surgery Database between January 1, 2011, and June 30, 2019, was performed. The exposure variable of interest was use of intraoperative TEE during CABG compared with no TEE. The primary outcome was operative mortality. The association of TEE with unplanned valve surgery was also assessed.
Results
Of 1,255,860 planned isolated CABG procedures across 1218 centers, 676,803 (53.9%) had intraoperative TEE. The percentage of patients receiving intraoperative TEE increased over time from 39.9% in 2011 to 62.1% in 2019 (p trend <0.0001). CABG patients undergoing intraoperative TEE had lower odds of mortality (adjusted odds ratio: 0.95; 95% confidence interval: 0.91 to 0.99; p = 0.025), with heterogeneity across STS risk groups (p interaction = 0.015). TEE was associated with increased odds of unplanned valve procedure in lieu of planned isolated CABG (adjusted odds ratio: 4.98; 95% confidence interval: 3.98 to 6.22; p < 0.0001).
Conclusions
Intraoperative TEE usage during planned isolated CABG is associated with lower operative mortality, particularly in higher-risk patients, as well as greater odds of unplanned valve procedure. These findings support usage of TEE to improve outcomes for isolated CABG for high-risk patients.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

J Am Coll Cardiol: 12 Jul 2021; 78:112-122

Improving Terminology to Describe Coronary Artery Procedures: JACC Review Topic of the Week.

Doenst T, Bonow RO, Bhatt DL, Falk V, Gaudino M
Coronary artery disease (CAD) is treated with medical therapy with or without percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). The latter 2 options are commonly referred to as \"myocardial revascularization\" procedures. We reason that this term is inappropriate because it is suggestive of a single treatment effect of PCI and CABG (ie, the reestablishment of blood flow to ischemic myocardium) and obscures key mechanisms, such as the improvement in coronary flow capability in the absence of ongoing ischemia, the reperfusion in the presence of ischemia, and the prevention of myocardial infarction from CAD progression. We review the current evidence on the topic and suggest the use of a purely descriptive terminology (\"invasive treatment by PCI or CABG\") which has the potential to improve clinical decision making and guide future trial design.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

J Am Coll Cardiol: 12 Jul 2021; 78:180-188

Efficacy and safety of low-dose colchicine in patients with coronary disease: a systematic review and meta-analysis of randomized trials.

Fiolet ATL, Opstal TSJ, Mosterd A, Eikelboom JW, ... Tijssen JGP, Cornel JH
Aims
Recent randomized trials demonstrated a benefit of low-dose colchicine added to guideline-based treatment in patients with recent myocardial infarction or chronic coronary disease. We performed a systematic review and meta-analysis to obtain best estimates of the effects of colchicine on major adverse cardiovascular events (MACE).
Methods and results
We searched the literature for randomized clinical trials of long-term colchicine in patients with atherosclerosis published up to 1 September 2020. The primary efficacy endpoint was MACE, the composite of myocardial infarction, stroke, or cardiovascular death. We combined the results of five trials that included 11 816 patients. The primary endpoint occurred in 578 patients. Colchicine reduced the risk for the primary endpoint by 25% [relative risk (RR) 0.75, 95% confidence interval (CI) 0.61-0.92; P = 0.005], myocardial infarction by 22% (RR 0.78, 95% CI 0.64-0.94; P = 0.010), stroke by 46% (RR 0.54, 95% CI 0.34-0.86; P = 0.009), and coronary revascularization by 23% (RR 0.77, 95% CI 0.66-0.90; P < 0.001). We observed no difference in all-cause death (RR 1.08, 95% CI 0.71-1.62; P = 0.73), with a lower incidence of cardiovascular death (RR 0.82, 95% CI 0.55-1.23; P = 0.34) counterbalanced by a higher incidence of non-cardiovascular death (RR 1.38, 95% CI 0.99-1.92; P = 0.060).
Conclusion
Our meta-analysis indicates that low-dose colchicine reduced the risk of MACE as well as that of myocardial infarction, stroke, and the need for coronary revascularization in a broad spectrum of patients with coronary disease. There was no difference in all-cause mortality and fewer cardiovascular deaths were counterbalanced by more non-cardiovascular deaths.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: [email protected]

Eur Heart J: 20 Jul 2021; 42:2765-2775

Post-stenting fractional flow reserve vs coronary angiography for optimisation of percutaneous coronary intervention: TARGET-FFR trial.

Collison D, Didagelos M, Aetesam-Ur-Rahman M, Copt S, ... Berry C, Oldroyd KG
Aims 
A fractional flow reserve (FFR) value ≥0.90 after percutaneous coronary intervention (PCI) is associated with a reduced risk of adverse cardiovascular events. TARGET-FFR is an investigator-initiated, single-centre, randomized controlled trial to determine the feasibility and efficacy of a post-PCI FFR-guided optimization strategy vs. standard coronary angiography in achieving final post-PCI FFR values ≥0.90.
Methods and results 
After angiographically guided PCI, patients were randomized 1:1 to receive a physiology-guided incremental optimization strategy (PIOS) or a blinded coronary physiology assessment (control group). The primary outcome was the proportion of patients with a final post-PCI FFR ≥0.90. Final FFR ≤0.80 was a prioritized secondary outcome. A total of 260 patients were randomized (131 to PIOS, 129 to control) and 68.1% of patients had an initial post-PCI FFR <0.90. In the PIOS group, 30.5% underwent further intervention (stent post-dilation and/or additional stenting). There was no significant difference in the primary endpoint of the proportion of patients with final post-PCI FFR ≥0.90 between groups (PIOS minus control 10%, 95% confidence interval -1.84 to 21.91, P = 0.099). The proportion of patients with a final FFR ≤0.80 was significantly reduced when compared with the angiography-guided control group (-11.2%, 95% confidence interval -21.87 to -0.35], P = 0.045).
Conclusion 
Over two-thirds of patients had a physiologically suboptimal result after angiography-guided PCI. An FFR-guided optimization strategy did not significantly increase the proportion of patients with a final FFR ≥0.90, but did reduce the proportion of patients with a final FFR ≤0.80.

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

Eur Heart J: 18 Jul 2021; epub ahead of print

Predicting In-Hospital Mortality in Patients Undergoing Percutaneous Coronary Intervention.

Castro-Dominguez YS, Wang Y, Minges KE, McNamara RL, ... Curtis JP, Cavender MA
Background
Standardization of risk is critical in benchmarking and quality improvement efforts for percutaneous coronary interventions (PCIs). In 2018, the CathPCI Registry was updated to include additional variables to better classify higher-risk patients.
Objectives
This study sought to develop a model for predicting in-hospital mortality risk following PCI incorporating these additional variables.
Methods
Data from 706,263 PCIs performed between July 2018 and June 2019 at 1,608 sites were used to develop and validate a new full and pre-catheterization model to predict in-hospital mortality, and a simplified bedside risk score. The sample was randomly split into a development cohort (70%, n = 495,005) and a validation cohort (30%, n = 211,258). The authors created 1,000 bootstrapped samples of the development cohort and used stepwise selection logistic regression on each sample. The final model included variables that were selected in at least 70% of the bootstrapped samples and those identified a priori due to clinical relevance.
Results
In-hospital mortality following PCI varied based on clinical presentation. Procedural urgency, cardiovascular instability, and level of consciousness after cardiac arrest were most predictive of in-hospital mortality. The full model performed well, with excellent discrimination (C-index: 0.943) in the validation cohort and good calibration across different clinical and procedural risk cohorts. The median hospital risk-standardized mortality rate was 1.9% and ranged from 1.1% to 3.3% (interquartile range: 1.7% to 2.1%).
Conclusions
The risk of mortality following PCI can be predicted in contemporary practice by incorporating variables that reflect clinical acuity. This model, which includes data previously not captured, is a valid instrument for risk stratification and for quality improvement efforts.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

J Am Coll Cardiol: 19 Jul 2021; 78:216-229

High spatial endothelial shear stress gradient independently predicts site of acute coronary plaque rupture and erosion.

Thondapu V, Mamon C, Poon EKW, Kurihara O, ... Barlis P, Jang IK
Aims
To investigate local haemodynamics in the setting of acute coronary plaque rupture and erosion.
Methods and results
Intracoronary optical coherence tomography performed in 37 patients with acute coronary syndromes caused by plaque rupture (n = 19) or plaque erosion (n = 18) was used for three-dimensional reconstruction and computational fluid dynamics simulation. Endothelial shear stress (ESS), spatial ESS gradient (ESSG), and oscillatory shear index (OSI) were compared between plaque rupture and erosion through mixed-effects logistic regression. Lipid, calcium, macrophages, layered plaque, and cholesterol crystals were also analysed. By multivariable analysis, only high ESSG [odds ratio (OR) 5.29, 95% confidence interval (CI) 2.57-10.89, P < 0.001], lipid (OR 12.98, 95% CI 6.57-25.67, P < 0.001), and layered plaque (OR 3.17, 95% CI 1.82-5.50, P < 0.001) were independently associated with plaque rupture. High ESSG (OR 13.28, 95% CI 6.88-25.64, P < 0.001), ESS (OR 2.70, 95% CI 1.34-5.42, P = 0.005), and OSI (OR 2.18, 95% CI 1.33-3.54, P = 0.002) independently associated with plaque erosion. ESSG was higher at rupture sites than erosion sites [median (interquartile range): 5.78 (2.47-21.15) vs. 2.62 (1.44-6.18) Pa/mm, P = 0.009], OSI was higher at erosion sites than rupture sites [1.04 × 10-2 (2.3 × 10-3-4.74 × 10-2) vs. 1.29 × 10-3 (9.39 × 10-5-3.0 × 10-2), P < 0.001], but ESS was similar (P = 0.29).
Conclusions
High ESSG is independently associated with plaque rupture while high ESSG, ESS, and OSI associate with plaque erosion. While ESSG is higher at rupture sites than erosion sites, OSI is higher at erosion sites and ESS was similar. These results suggest that ESSG and OSI may play critical roles in acute plaque rupture and erosion, respectively.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: [email protected]

Cardiovasc Res: 06 Jul 2021; 117:1974-1985

Prasugrel versus ticagrelor in patients with myocardial infarction undergoing percutaneous coronary intervention.

Venetsanos D, Träff E, Erlinge D, Hagström E, ... Jernberg T, Alfredsson J
Objective
The comparative efficacy and safety of prasugrel and ticagrelor in patients with myocardial infarction (MI) treated with percutaneous coronary intervention (PCI) remain unclear. We aimed to investigate the association of treatment with clinical outcomes.
Methods
In the SWEDEHEART (Swedish Web-system for enhancement and development of evidence-based care in heart disease evaluated according to recommended therapies) registry, all patients with MI treated with PCI and discharged on prasugrel or ticagrelor from 2010 to 2016 were included. Outcomes were 1-year major adverse cardiac and cerebrovascular events (MACCE, death, MI or stroke), individual components and bleeding. Multivariable adjustment, inverse probability of treatment weighting (IPTW) and propensity score matching (PSM) were used to adjust for confounders.
Results
We included 37 990 patients, 2073 in the prasugrel group and 35 917 in the ticagrelor group. Patients in the prasugrel group were younger, more often admitted with ST elevation MI and more likely to have diabetes. Six to twelve months after discharge, 20% of patients in each group discontinued the P2Y12 receptor inhibitor they received at discharge. The risk for MACCE did not significantly differ between prasugrel-treated and ticagrelor-treated patients (adjusted HR 1.03, 95% CI 0.86 to 1.24). We found no significant difference in the adjusted risk for death, recurrent MI or stroke alone between the two treatments. There was no significant difference in the risk for bleeding with prasugrel versus ticagrelor (2.5% vs 3.2%, adjusted HR 0.92, 95% CI 0.69 to 1.22). IPTW and PSM analyses confirmed the results.
Conclusion
In patients with MI treated with PCI, prasugrel and ticagrelor were associated with similar efficacy and safety during 1-year follow-up.

© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.

Heart: 29 Jun 2021; 107:1145-1151

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)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.

Heart: 06 Jul 2021; epub ahead of print

Effect of a smartphone-based intervention on secondary prevention medication prescriptions after coronary artery bypass graft surgery: The MISSION-1 randomized controlled trial.

Qu J, Du J, Rao C, Chen S, ... Zheng Z, MISSION-1 Collaborative Group
Background
Studies found that patients who underwent coronary artery bypass grafting (CABG) often fail to receive optimal evidence-based secondary prevention medications. We evaluated the effectiveness of a smartphone-based quality improvement effort on improving the prescription of medical therapies.
Methods
In this cluster-randomized controlled trial, 60 hospitals were randomized to a control arm (n = 30) or to an intervention arm using smartphone-based multifaceted quality improvement interventions (n = 30). The primary outcome was the prescription of statin. The secondary outcomes were prescription of beta-blocker, angiotensin-converting enzyme inhibitor, or angiotensin receptor blocker (ACE inhibitor or ARB), and optimal medical therapy for eligible patients.
Results
Between June 1, 2015 and September 15, 2016, a total of 10,006 CABG patients were enrolled (5,653 in 26 intervention and 4,353 in 29 control hospitals, 5 hospitals withdrew). Statin prescribing rate was 87.8% in the intervention arm and 84.4% in the control arm. We saw no evidence of an effect of intervention on statin prescribing in the intention-to-treat analysis (odds ratio [OR], 1.31; 95% confidence interval (CI), 0.68-2.54; P = .43) or in key patient subsets. The prescription rates of ACE inhibitor or ARB and optimal medical therapy were comparable between study groups, while beta-blocker was more often prescribed in the intervention arm. Post hoc analysis demonstrated a greater increase in statin prescribing rate over time in the intervention arm.
Conclusions
A smartphone-based quality improvement intervention compared with usual care did not increase statin prescribing for patients who received CABG. New studies focusing on the best practice of this technique may be warranted.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am Heart J: 29 Jun 2021; 237:79-89

Potent P2Y12 inhibitors versus Clopidogrel in elderly patients with acute coronary syndrome: Systematic review and meta-analysis.

Fujisaki T, Kuno T, Ando T, Briasoulis A, Takagi H, Bangalore S
Background
Potent P2Y12 inhibitors reduce cardiovascular events but increase bleeding in patients presenting with acute coronary syndrome (ACS). Elderly patients are at increased risk of bleeding and whether the benefit-risk ratio of potent P2Y12 inhibitors remains favorable is not known.
Objectives
To investigate the efficacy and safety of potent P2Y12 inhibitors versus clopidogrel in elderly patients with ACS.
Methods
PUBMED and EMBASE were searched through July 2020 for randomized control trials (RCTs) or subgroup analyses of RCTs investigating potent P2Y12 inhibitors (prasugrel or ticagrelor) or clopidogrel in elderly (age ≥ 65 years) patients with ACS. The primary outcome was major adverse cardiovascular events (MACE).
Results
Our search identified 9 RCTs with a total of 10,792 elderly patients. When compared with clopidogrel, potent P2Y12 inhibitors had similar risk of MACE (hazard ratio (HR): 0.94; 95%; confidence interval (CI) [0.85-1.06], P = .31, I² = 9%), all-cause mortality (HR: 0.89; 95% CI [0.74-1.07], P = .22, I² = 29%), reduced the risk of cardiovascular death (HR: 0.82; 95% CI [0.68-0.98], P = .03, I² = 16%) but increased the risk of major bleeding (HR: 1.27; 95% CI [1.04-1.56], P = .02, I² = 0%). In a subgroup analysis, ticagrelor reduced all-cause mortality (HR: 0.73; 95% CI [0.55-0.98]) and cardiovascular death (HR: 0.70; 95% CI [0.54-0.90]) compared with clopidogrel.
Conclusions
Among elderly patients with ACS, potent P2Y12 inhibitors reduce cardiovascular death but increase bleeding with no difference in MACE or all-cause death when compared with clopidogrel. Further RCTs are needed to refine P2Y12 inhibitor selection for elderly patients with ACS.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am Heart J: 29 Jun 2021; 237:34-44

Clinical features and outcomes in patients with cardiogenic shock complicating acute myocardial infarction: early vs recent experience with impella.

Singh H, Mehta RH, O\'Neill W, Kapur NK, ... Rosman H, Kaki A
Objectives
To compare clinical features and outcomes in patients with acute myocardial infarction complicated by cardiogenic shock (AMICS) treated in the early experience with Impella percutaneous ventricular assist device and patients treated recently.
Background
Since pre-market approval (PMA) of Impella device as treatment for AMICS, use of the device has grown considerably.
Methods
We retrospectively analyzed 649 AMICS patients treated with perioperative Impella, with 291 patients treated from 2008 to 2014 comprising the early experience cohort and 358 patients treated from 2017 to 2019 comprising the recent experience cohort. The primary end point was risk adjusted in-hospital mortality.
Results
Mean age and gender distribution of patients was similar in the two cohorts. The recent cohort had more invasive hemodynamic monitoring (64% vs 46%; P < .001) and less use of an intra-aortic balloon pump prior to Impella (15% vs 41%; P < .001). Recently treated patients were significantly more likely to receive Impella support prior to PCI (58% vs 44%; P = .005). In-hospital mortality was lower in the recent cohort (48% vs 56%; P = .043). This difference was however no longer significant after risk adjustment (adjusted OR 0.89, 95% CI 0.59-1.34, P = .59). Rates of acute kidney injury, major bleeding, and vascular complications requiring surgery were also significantly lower in the recent cohort.
Conclusions
Use of Impella for AMICS during recent years is associated with lower unadjusted in-hospital mortality, which may reflect better patient selection, earlier device implantation, and improved management algorithms. In-depth understanding of these factors may inform the development of future treatment protocols.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am Heart J: 30 Jul 2021; 238:66-74

Severe Mitral Paravalvular Leak Treated with Percutaneous Paravalvular Leak Closure with Underlying Severe Mitral Annular Calcium.

Sudhakaran S, Tandon A, Rafael AE, Choi JW
Standard operative mitral valve replacement for mitral stenosis in the setting of severe mitral annular calcium has been associated with increased morbidity and mortality. Inability to ensure a well seated prosthesis may lead to periprosthetic leak. We present a case of severe paravalvular leak, causing significant hemolysis, after mitral valve replacement with underling severe mitral annular calcium. The leak was successfully repaired using a transseptal percutaneous approach, with subsequent resolution of hemolysis.

Published by Elsevier Inc.

Am J Cardiol: 31 Jul 2021; 152:165-167

Comparison of Outcomes of Coronary Artery Disease Treated by Percutaneous Coronary Intervention in 3 Different Age Groups (<45, 46-65, and >65 Years).

Noaman S, Dinh D, Reid CM, Brennan AL, ... Duffy SJ, Chan W
There is paucity of data examining long-term outcomes of premature coronary artery disease (CAD). We aimed to investigate the short- and long-term clinical outcomes of patients with premature CAD treated by percutaneous coronary intervention (PCI) compared to older cohorts. We analyzed data from 27,869 patients who underwent PCI from 2005-2017 enrolled in a multicenter PCI registry. Patients were divided into three age groups: young group (≤ 45 years), middle-age group (46-65 years) and older group (>65 years). There were higher rates of current smokers in the young (n = 1,711) compared to the middle-age (n = 12,830) and older groups (n = 13,328) (54.2% vs 34.6% vs 11%) and the young presented more frequently with acute coronary syndrome (ACS) (78% vs 66% vs 62%), all p <0.05. There were also greater rates of cardiogenic shock (CS), out-of-hospital cardiac arrest (OHCA) and ST-elevation myocardial infarction (STEMI) in the young, all p <0.05. The young cohort with STEMI had higher rates of in-hospital, 30-day death, and long-term mortality (3.8% vs 0.2%, 4.3% vs 0.2% and 8.6% vs 3.1%, all p <0.05, respectively) compared to the non-STEMI subgroup. There was a stepwise increase in long-term mortality from the young, to middle-age, to the older group (6.1% vs 9.9% vs 26.8%, p <0.001). Younger age was an independent predictor of lower long-term mortality (HR 0.66, 95% CI 0.52-0.84, p = 0.001). In conclusion, younger patients presenting with STEMI had worse prognosis compared to those presenting with non-STEMI. Despite higher risk presentations among young patients, their overall prognosis was favorable compared to older age groups.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am J Cardiol: 31 Jul 2021; 152:19-26

Trends in Cerebral Embolic Protection Device Use and Association With Stroke Following Transcatheter Aortic Valve Implantation.

Kolte D, Khera S, Nazir S, Butala NM, Bhatt DL, Elmariah S
Stroke remains a serious complication of transcatheter aortic valve implantation (TAVI). Prior studies examining the association between cerebral embolic protection device (CEPD) use and stroke following TAVI have produced conflicting results. We used the Nationwide Readmissions Databases to identify all percutaneous (non-transapical) TAVIs performed in the US from July, 2017 to December, 2018. Overlap propensity score weighted logistic regression models were used to determine the association between CEPD use and outcomes. The primary outcome was in-hospital stroke or transient ischemic attack (TIA). Among 50,000 percutaneous TAVIs (weighted national estimate: 88,886 [SE: 2,819]), CEPD was used in 2,433 (weighted national estimate: 3,497 [SE: 857]). Nationally, the utilization rate of CEPD was 3.9% (SE: 0.9%) of all TAVIs during the overall study period, which increased from 0.8% (SE: 0.4%) in 2017Q3 to 7.6% (SE: 1.6%) in 2018Q4 (p<0.001). The proportion of hospitals using CEPD increased from 2.3% in 2017Q3 to 14.7% in 2018Q4 (p<0.001). There were no significant differences in rates of in-hospital stroke/TIA in TAVIs with versus without CEPD (2.6% vs 2.2%; unadjusted OR [95% CI] 1.18 [0.98-1.52]; overlap propensity score weighted OR [95% CI] 1.19 [0.81-1.75]). CEPD use was not associated with statistically significant lower rates of in-hospital stroke, ischemic stroke, hemorrhagic stroke, TIA, all-cause mortality, or discharge to skilled nursing facility. In conclusion, the rates of CEPD utilization and proportion of TAVI hospitals using CEPD increased during the study period. The use of CEPD during TAVI was not associated with statistically significant lower rates of in-hospital stroke, TIA, or mortality.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am J Cardiol: 31 Jul 2021; 152:106-112

Effect of once-weekly exenatide on hospitalization for acute coronary syndrome or coronary revascularization in patients with type 2 diabetes mellitus.

Barbery CE, Giczewska A, White J, Lokhnygina Y, ... Hernandez AF, Jones WS
Cardiovascular (CV) outcome studies of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have shifted the paradigm of type 2 diabetes management given their benefits regarding a reduction in major adverse CV events. However, the relationship between GLP-1 RAs and coronary revascularization remains poorly understood. In this EXSCEL post-hoc analysis, we used univariate Cox proportional models and Kaplan Meier survival analysis to evaluate the effect of once-weekly exenatide (EQW) on a composite outcome of hospitalization for acute coronary syndrome (ACS) or coronary revascularization. Similar models were utilized to evaluate the relationship between significant participant characteristics within the entire study population and the composite outcome. Of the 14,736 participants in EXSCEL with complete follow-up data, 1642 (11.1%) experienced an ACS or coronary revascularization event during a median follow-up of 3.3 years (interquartile range, 2.3-4.4). EQW had no effect on hospitalization for ACS or coronary revascularization (HR 1.00, 95% CI 0.91-1.10). Among EXSCEL participants, enrollment in Latin America (HR 0.51, 95% CI 0.43-0.60) and a history of peripheral artery disease (HR 0.79, 95% CI 0.70-0.90) were associated with a reduced risk for coronary revascularization, whereas enrollment in North America (HR 1.92, 95% CI 1.74-2.12), a history of CV disease (HR 3.24, 95% CI 2.78-3.78), and a previous myocardial infarction (HR 1.54, 95% CI 1.39-1.71) were associated with increased risk for study end points. EQW had no association with hospitalization for ACS or coronary revascularization. Participant enrollment location and CV disease burden may play a role in the variable CV efficacy of GLP-1 RAs that has been observed in trials thus far.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am Heart J: 30 Aug 2021; 239:59-63

Drug Adherence and Long-Term Outcomes in Non-Revascularized Patients Following Acute Myocardial Infarction.

Khan R, Kaul P, Islam S, Savu A, ... Welsh RC, Goodman SG
This study examined long-term outcomes and adherence to guideline-based medications in non-revascularized acute myocardial infarction (MI) patients undergoing and not undergoing angiography. We analyzed non-revascularized MI patients hospitalized in Alberta, Canada between 2010-2016 and categorized them according to whether they had undergone coronary angiography. Adherence to guideline-based medications was determined by the proportion of days covered (PDC) and subdivided into categories based on PDC: 0% (none), 1-40% (low), 40-79% (intermediate) and ≥ 80% (high). Patients not undergoing angiography were older, less frequently male, and had more comorbidities. Those not receiving angiography had higher rates of 2-year myocardial infarction (9.9% vs 6.1%, p <0.001), heart failure (14.9% vs 6.1%, p <0.001), and mortality (29.4% vs 7.4%, p <0.001). Optimal medial therapy (OMT), defined by high PDC for the combination of lipid-modifying agents, β-blockers and angiotensin converting enzyme-inhibitors/receptor blockers (ACE-I/ARBs), was achieved in 32.9%. Patients not undergoing angiography had lower rates of OMT adherence (p <0.001). In patients not undergoing angiography, high-adherence to lipid-modifying agents (HR 0.70 [95% CI 0.57-0.87]), β-blockers (HR 0.78 [0.62-0.97]), ACE-I/ARBs (HR 0.64 [0.52-0.79]) and OMT (HR 0.56 [0.40-0.77]) was independently associated with lower 2-year mortality. In conclusion, MI patients not receiving angiography had low adherence rates to guideline-based pharmacotherapies and high rates of long-term outcomes, suggesting potential treatment targets to improve prognosis in non-invasively managed MI patients.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am J Cardiol: 31 Jul 2021; 152:49-56

Prognostic Impact of Branch Vessel Involvement on Computed Tomography versus Clinical Presentation of Malperfusion in Patients With Type a Acute Aortic Dissection.

Hashimoto O, Saito Y, Nakayama T, Okino S, ... Ishibashi I, Kobayashi Y
Type A acute aortic dissection (AAD) is a life-threatening disease. The use of contrast-enhanced computed tomography (CT) for diagnosing AAD has increased, and CT can provide pathophysiologic information on dissection such as intramural hematoma (IMH), longitudinal extent of dissection, and branch vessel involvement. However, the prognostic impact of these CT findings is poorly investigated. This multicenter registry included 703 patients with type A AAD. The longitudinal extent of dissection and IMH was determined on CT. Branch vessel involvement was defined as dissection extended into coronary, cerebral, and visceral arteries on CT. The evidence of malperfusion was defined based on clinical presentations. The primary endpoint was in-hospital death. Of 703 patients, 126 (18%) died during hospitalization. Based on contrast-enhanced CT findings, longitudinal extent of dissection was not associated with in-hospital death, while patients with IMH had lower in-hospital mortality than those without (13% vs 22%, p = 0.004). Coronary, cerebral, and visceral artery involvement on CT was found in 6%, 55%, and 32%. In patients with coronary artery involvement, 90% had clinical coronary malperfusion, while only 25% and 21% of patients with cerebral and visceral artery involvement had clinical evidence of corresponding organ malperfusion. Multivariable analysis showed evidence of malperfusion as a significant factor associated with in-hospital mortality. In conclusions, branch vessel involvement on CT was not always associated with end-organ malperfusion in patients with type A AAD, especially in cerebral and visceral arteries. Clinical evidence of malperfusion was significantly associated with in-hospital mortality beyond branch vessel involvement on CT.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am J Cardiol: 31 Jul 2021; 152:158-163

Incidence, Predictors, and Prognostic Impact of Immediate Improvement in Left Ventricular Systolic Function After Transcatheter Aortic Valve Implantation.

Jeong YJ, Ahn JM, Kang DY, Park H, ... Kim DH, Park DW
Immediate improvement in left ventricular ejection fraction (LVEF) following transcatheter aortic valve implantation (TAVI) is common; however, data on the pattern and prognostic value of this improvement are limited. To evaluate the incidence, predictors, and clinical impact of immediate improvement in LVEF, we studied 694 consecutive patient who had underwent successful TAVI for severe aortic stenosis (AS) between March 2010 and December 2019. We defined immediate improvement of LVEF as an absolute increase of ≥5% in LVEF at post-procedure echocardiogram. The primary outcome was major adverse cardiac or cerebrovascular event (MACCE), defined as a composite of death from cardiovascular cause, myocardial infarction, stroke, or rehospitalization from cardiovascular cause. Among them, 160 patients showed immediate improvement in LVEF. The independent predictors of immediate LVEF improvement were absence of hypertension and baseline significant aortic regurgitation, and greater baseline LV mass index. Immediate improvement in LVEF was significantly associated with a lower risk of MACCE (adjusted hazard ratio, 0.48; 95% confidence interval, 0.28-0.81; p = 0.01). In conclusion, approximately one-fourth of patients with severe AS who underwent TAVI showed immediate improvement in LVEF during index hospitalization. Immediate LVEF recovery was associated with a lower risk of MACCE during follow-up.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am J Cardiol: 31 Jul 2021; 152:99-105

Effect of Location on Treatment and Outcomes of Cardiac Arrest Complicating Acute Myocardial Infarction in England & Wales.

Dafaalla M, Rashid M, Weston C, Kinnaird T, ... Curzen N, Mamas MA
We investigated the incidence, management, and outcomes of acute myocardial infarction (AMI) patients according to cardiac arrest location. Patients admitted with a diagnosis of AMI between January 1, 2010 to March 31, 2017 from the Myocardial Ischaemia National Audit Project (MINAP) were studied. We used logistic regression models to evaluate predictors of the clinical outcomes and treatment strategy. The study population consisted of 580,796 patients admitted with AMI stratified into three groups: out of hospital cardiac arrest (OOHCA) (16,278[2.8%]), in-hospital cardiac arrest (IHCA) (21,073[3.7%]), plus a reference group consisting of those without cardiac arrest (non-cardiac arrest (543,418[93.5%]). IHCA declined steadily (from 666 per 1000 in 2010 to 477 per 1000 AMI with cardiac arrest admissions in 2017) with a commensurate rise in OOHCA (from 344 per 1000 to 533 per 1000 AMI with cardiac arrest admissions). Coronary angiography utilization (OOHCA 81.1% vs IHCA 60.3% vs non-cardiac arrest 70.4%, p < 0.001) and PCI (OOHCA 40% vs IHCA 32.8% vs non-cardiac arrest 45.2%, p < 0.001) were higher in OOHCA. In-hospital mortality odds were greatest for IHCA (OR 35.3, 95% CI 33.4-37.2) compared to OOHCA (OR 12.7, 95% CI 11.9-13.6), with the worse outcomes seen in patients on medical wards (OR 97.37, 95% CI 87.02-108.95) and the best outcomes seen in the emergency department (OR 8.35, 95% CI 7.32-9.53). In conclusion, outcomes of AMI complicated by cardiac arrest depended on cardiac arrest location, especially the outcomes of the IHCA.

Copyright © 2021. Published by Elsevier Inc.

Am J Cardiol: 31 Jul 2021; 152:1-10

Automated classification of coronary atherosclerotic plaque in optical frequency domain imaging based on deep learning.

Shibutani H, Fujii K, Ueda D, Kawakami R, ... Miki Y, Shiojima I
Background:
and aims
We developed a deep learning (DL) model for automated atherosclerotic plaque categorization using optical frequency domain imaging (OFDI) and performed quantitative and visual evaluations.
Methods
A total of 1103 histological cross-sections from 45 autopsy hearts were examined to compare the ex vivo OFDI scans. The images were segmented and annotated considering four histological categories: pathological intimal thickening (PIT), fibrous cap atheroma (FA), fibrocalcific plaque (FC), and healed erosion/rupture (HER). The DL model was developed based on pyramid scene parsing network (PSPNet). Given an input image, a convolutional neural network (ResNet50) was used as an encoder to generate feature maps of the last convolutional layer.
Results
For the quantitative evaluation, the mean F-score and IoU values, which are used to evaluate how close the predicted results are to the ground truth, were used. The validation and test dataset had F-score and IoU values of 0.63, 0.49, and 0.66, 0.52, respectively. For the section-level diagnostic accuracy, the areas under the receiver-operating characteristic curve produced by the DL model for FC, PIT, FA, and HER were 0.91, 0.85, 0.86, and 0.86, respectively, and were comparable to those of an expert observer.
Conclusions
DL semantic segmentation of coronary plaques in OFDI images was used as a tool to automatically categorize atherosclerotic plaques using histological findings as the gold standard. The proposed method can support interventional cardiologists in understanding histological properties of plaques.

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

Atherosclerosis: 29 Jun 2021; 328:100-105

MAUDE Database Analysis of Post-Approval Outcomes following Left Atrial Appendage Closure with the Watchman Device.

Ledesma PA, Uzomah UA, Yu X, Shaqdan A, ... Ptaszek LM, Ruskin JN
Left atrial appendage closure (LAAC) is an important strategy to reduce stroke risk in patients with non-valvular atrial fibrillation (AF) who are at high risk of bleeding on long-term anticoagulation. Real-world assessments of the safety of the Watchman LAAC device remain limited. The objective of this study was to determine the frequency and timing of adverse events associated with Watchman LAAC device implants performed after FDA approval. Adverse events associated with Watchman LAAC implants performed between March 2015 and March 2019 were identified through a search of the FDA Manufacturer and User Facility Device Experience (MAUDE) database. During the study period, 3,652 unique adverse events were identified. An estimated 43,802 Watchman implants were performed in the United States during the study period. The overall adverse event rate was 7.3% and the mortality rate was 0.4%. Of the 159 unique types of adverse events identified, pericardial effusion was most common (1.4%). Most adverse events (73%) occurred intraoperatively (59%) or within 1 day of the procedure (15%). However, 19% of deaths, 24% of strokes and 27% of device embolizations occurred >1 month after implantation. The rates of most Watchman-related adverse events reported in the MAUDE database were comparable to those observed in clinical trials. A majority of adverse events occurred within 1 day of implant. In conclusion, while the absolute event rates were low, a significant proportion of device embolizations, strokes, and deaths occurred >1 month after Watchman implant.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am J Cardiol: 31 Jul 2021; 152:78-87

Unprotected Left Main Percutaneous Coronary Intervention With or Without Hemodynamic Support.

Khalid N, Zhang C, Shea C, Ahmad SA, ... Satler LF, Waksman R
Hemodynamic support is widely utilized for unprotected left main (ULM) percutaneous coronary interventions (PCI) despite lack of evidence from randomized studies and the risk of device-related complications. We aimed to compare ULMPCI with and without intra-aortic balloon pump (IABP) support. A single-center, retrospective analysis was performed for patients undergoing ULMPCI with and without IABP support. Clinical, procedural, in-hospital, and 30-day cardiovascular outcomes were compared. From 2003 through 2018, 217 patients underwent non-emergent ULMPCI, 55 with elective IABP support (IABP group), and 162 without support (No-IABP group). The study population comprised 56.4% men and 74.5% Caucasians in the IABP group and 53.7% men and 62.3% Caucasians in the No-IABP group. The mean age for IABP and No-IABP group patients was 75.75 ± 12.34 years and 73.47 ± 15.19 years, respectively (p = 0.315). Procedural success was achieved in 99% of IABP and 95.3% of No-IABP patients (p = 0.089). In-hospital and 30-day mortality was 5.5% for the IABP group and 5.6% for the No-IABP group (p = 0.977). Rates of major complications were statistically similar between the groups. Bailout IABP was required in 10% of No-IABP patients. Hospital and intensive care unit length of stay was statistically longer in the IABP group. In conclusion, ULMPCI without IABP support was not associated with increased mortality and major cardiovascular outcomes compared with supported patients and was associated with shorter hospital and intensive care unit stay. A randomized trial comparing unsupported versus supported ULMPCI is warranted to identify patients who would benefit from hemodynamic support.

Copyright © 2021. Published by Elsevier Inc.

Am J Cardiol: 12 Jul 2021; epub ahead of print

Outcomes Following Aortic Stenosis Treatment (Transcatheter vs Surgical Replacement) in Women vs Men (From a Nationwide Analysis).

Deharo P, Cuisset T, Bisson A, Herbert J, ... Bourguignon T, Fauchier L
Gender-differences in survival following transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) have been suggested. The objective of this study was to analyze outcomes following TAVR according to gender and to compare outcomes between TAVR and SAVR in women, at a nationwide level. Based on the French administrative hospital-discharge database, the study collected information for all consecutive patients treated with TAVR and SAVR between 2010 and 2019. Outcomes were analyzed according to gender and propensity score matching was used for the analysis of outcomes. In total 71,794 patients were identified in the database. After matching on baseline characteristics, we analyzed 12,336 women and 12,336 men treated with TAVR. In a second matched analysis, we compared 9,297 women treated with TAVR and 9,297 women treated with SAVR. Long term follow-up showed lower risk of all-cause death (12.7% vs 14.8%, hazard ratio (HR) 0.85, 95% CI 0.81 to 0.90) in women than men. Although the difference in cardiovascular death remained non-significant (5.8% vs 6.0%, HR 0.96, 95% CI 0.88 to 1.05), non-cardiovascular death was less frequent in women than in men following TAVR (6.9% vs 8.8% HR 0.78, 95%CI 0.72 to 0.84).When TAVR was compared with SAVR in women, long-term follow-up with TAVR showed higher rates of all-cause death (11.2% vs 6.5%, HR 1.91, 95%CI 1.78 to 2.05), cardiovascular death (5.0% vs 3.2%, HR 1.44, 95%CI 1.30 to 1.59), and non-cardiovascular death (6.2% vs 3.3%, HR 2.48, 95% CI 2.25 to 2.72). In conclusion, we observed that women undergoing TAVR have lower long-term all-cause mortality as compared with TAVR in men, driven by non-cardiovascular mortality. SAVR was associated with lower rates of long-term cardiovascular adverse events in women as compared with TAVR.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am J Cardiol: 09 Jul 2021; epub ahead of print

Malignancy-Associated Non-Bacterial Thrombotic Endocarditis Causing Aortic Regurgitation and Leading to Aortic Valve Replacement.

Makhdumi M, Meyer DM, Roberts WC
Described herein is a 48-year-old woman with metastatic ovarian cancer who developed aortic regurgitation considered clinically to be the result of infective endocarditis but operative resection of the three aortic valve cusps disclosed the valve lesions to be typical of non-bacterial thrombotic endocarditis (NBTE). Aortic regurgitation as a consequence of NBTE is rare but at least 9 cases have been reported previously.

Copyright © 2021. Published by Elsevier Inc.

Am J Cardiol: 10 Jul 2021; epub ahead of print

Ticagrelor and the risk of infections during hospitalization in patients with ST-elevation myocardial infarction undergoing percutaneous coronary intervention.

Lian XJ, Dai YN, Xue JH, Zeng LH, ... Liu YH, Duan CY
Background:
and aims
Although ticagrelor exerts an antibacterial activity, its effect on infections in patients with ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI) is unclear. We aimed to assess whether ticagrelor and clopidogrel affect infections in these patients during hospitalization.
Methods
A total of 2116 consecutive patients with STEMI undergoing PCI were divided into the ticagrelor (n = 388) and clopidogrel (n = 1728) groups. The primary outcome was infection onset. Secondary outcomes were in-hospital all-cause death and major adverse cardiovascular and cerebrovascular events (MACCE). Propensity score analyses were conducted to test the robustness of the results.
Results
Infections developed in 327 (15.4%) patients. There was no significant difference in infection between both groups (ticagrelor vs. clopidogrel: 13.1% vs. 16.0%, p = 0.164). Patients in the ticagrelor group had lower rates of in-hospital all-cause death and MACCE than patients in the clopidogrel group. Multivariate logistic regression analysis determined that ticagrelor and clopidogrel had a similar preventive effect on infections during hospitalization (adjusted odds ratio [OR] = 1.20; 95% confidence interval [CI] = 0.80-1.78, p = 0.380). Compared to the patients treated with clopidogrel, patients treated with ticagrelor had a slightly lower risk of other outcomes, but no statistical difference. Propensity score analyses demonstrated similar results for infections and other outcomes.
Conclusions
Compared with clopidogrel treatment, ticagrelor treatment did not significantly alter the risk of infections during hospitalization among STEMI patients undergoing PCI, but was associated with a slightly lower risk of in-hospital all-cause death and MACCE.

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

Atherosclerosis: 03 Jul 2021; 331:6-11

Comparison of Outcomes of Patients with vs without Previous Coronary Artery Bypass Graft Surgery Presenting with ST-Segment Elevation Acute Myocardial Infarction.

Karacsonyi J, Schmidt CW, Okeson BK, Garcia S, ... Wang YL, Brilakis ES
The outcomes of patients with previous coronary bypass graft surgery (CABG) presenting with ST-segment elevation acute myocardial infarction (STEMI) have received limited study. We compared the clinical and procedural characteristics and outcomes of STEMI patients with and without previous CABG in a contemporary multicenter STEMI registry between 2003 and 2020. The primary outcomes of the study were mortality and major cardiac adverse events (MACE: death, MI or stroke). Survival curves were derived using the Kaplan-Meier method and compared with the log-rank test. Of the 13,893 patients included in the analyses, 7.2% had previous CABG. Mean age was 62.4 ± 13.6 years, most patients (71%) were men and 22% had diabetes. Previous CABG patients were older (69.0 ± 11.7 vs 61.9 ± 13.6 years, p <0.001) and more likely to have diabetes (40% vs 21%, p <0.001) compared with patients without previous CABG. Previous CABG patients had higher mortality and MACE at 5 years (p <0.001). Outcomes were similar with saphenous vein graft vs native coronary culprits. Previous CABG remained associated with mortality from discharge to 18 months (p = 0.044) and from 18 months to 5 years (p <0.001) after adjusting for baseline characteristics. Long term outcomes after STEMI were worse among patients with previous CABG compared with patients without previous CABG, even after adjustment for baseline characteristics.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am J Cardiol: 05 Jul 2021; epub ahead of print

Comparison of Ticagrelor Versus Clopidogrel on Cerebrovascular Microembolic Events and Platelet Inhibition during Transcatheter Aortic Valve Implantation.

Vavuranakis MA, Kalantzis C, Voudris V, Kosmas E, ... Leucker TM, Vavuranakis M
The impact of the antiplatelet regimen and the extent of associated platelet inhibition on cerebrovascular microembolic events during transcatheter aortic valve implantation (TAVI) are unknown. Our aim was to evaluate the effects of ticagrelor versus clopidogrel and of platelet inhibition on the number of cerebrovascular microembolic events in patients undergoing TAVI. Patients scheduled for TAVI were randomized previous to the procedure to either aspirin and ticagrelor or to aspirin and clopidogrel. Platelet inhibition was expressed in P2Y12 reaction units (PRU) and percentage of inhibition. High intensity transient signals (HITS) were assessed with transcranial Doppler (TCD). Safety outcomes were recorded according to the VARC-2 definitions. Among 90 patients randomized, 6 had an inadequate TCD signal. The total number of procedural HITS was lower in the ticagrelor group (416.5 [324.8, 484.2]) (42 patients) than in the clopidogrel group (723.5 [471.5, 875.0]) (42 patients), p <0.001. After adjusting for the duration of the procedure, diabetes, extra-cardiac arteriopathy, BMI, hypertension, aortic valve calcium content, procedural ACT, and pre-implantation balloon valvuloplasty, patients on ticagrelor had on average 256.8 (95% CI: [-335.7, -176.5]) fewer total procedural HITS than patients on clopidogrel. Platelet inhibition was greater with ticagrelor 26 [10, 74.5] PRU than with clopidogrel 207.5 (120 to 236.2) PRU, p <0.001, and correlated significantly with procedural HITS (r = 0.5, p <0.05). In conclusion, ticagrelor resulted in fewer procedural HITS, compared with clopidogrel, in patients undergoing TAVI, while achieving greater platelet inhibition.

Copyright © 2021. Published by Elsevier Inc.

Am J Cardiol: 05 Jul 2021; epub ahead of print

Coronary Revascularization in the Past Two Decades in Japan (From the CREDO-Kyoto PCI/CABG Registries Cohort-1, -2, and -3).

Shiomi H, Morimoto T, Furukawa Y, Nakagawa Y, ... Minatoya K, Kimura T
The treatment of coronary artery disease has substantially changed over the past two decades. However, it is unknown whether and how much these changes have contributed to the improvement of long-term outcomes after coronary revascularization. We assessed trends in the demographics, practice patterns and long-term outcomes in 24,951 patients who underwent their first percutaneous coronary intervention (PCI) (n = 20,106), or isolated coronary artery bypass grafting (CABG) (n = 4,845) using the data in a series of the CREDO-Kyoto PCI/CABG Registries (Cohort-1 [2000 to 2002]: n = 7,435, Cohort-2 [2005 to 2007]: n = 8,435, and Cohort-3 [2011 to 2013]: n = 9,081). From Cohort-1 to Cohort-3, the patients got progressively older across subsequent cohorts (67.0 ± 10.0, 68.4 ± 9.9, and 69.8 ± 10.2 years, p_trend < 0.001). There was increased use of PCI over CABG (73.5%, 81.9%, and 85.2%, p_trend < 0.001) and increased prevalence of evidence-based medications use over time. The cumulative 3-year incidence of all-cause death was similar across the 3 cohorts (9.0%, 9.0%, and 9.3%, p = 0.74), while cardiovascular death decreased over time (5.7%, 5.1%, and 4.8%, p = 0.03). The adjusted risk for all-cause death and for cardiovascular death progressively decreased from Cohort-1 to Cohort-2 (HR:0.89, 95%CI:0.80 to 0.99, p = 0.03, and HR:0.80, 95%CI:0.70 to 0.92, p = 0.002, respectively), and from Cohort-2 to Cohort-3 (HR:0.86, 95%CI:0.78 to 0.95, p = 0.004, and HR:0.77, 95%CI:0.67-0.89, p < 0.001, respectively). The risks for stroke and repeated coronary revascularization also improved over time. In conclusions, we found a progressive and substantial reduction of adjusted risk for all-cause death, cardiovascular death, stroke, and repeated coronary revascularization over the past two decades in Japan.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am J Cardiol: 05 Jul 2021; epub ahead of print

Effect of Atorvastatin (10 mg) and Ezetimibe (10 mg) Combination Compared to Atorvastatin (40 mg) Alone on Coronary Atherosclerosis.

Oh PC, Jang AY, Ha K, Kim M, ... Han SH, Kang WC
It remains inconclusive whether the additional low-density lipoprotein cholesterol (LDL-C) lowering effects of ezetimibe added to statin on coronary atherosclerosis and clinical outcomes are similar to those of statin monotherapy in the setting of comparable LDL-C reduction. We aimed to determine whether there were distinguishable differences in their effects on coronary atherosclerosis with intermediate stenosis between the combination of moderate-intensity statin plus ezetimibe and high-intensity statin monotherapy. Forty-one patients with stable angina undergoing percutaneous coronary intervention were randomized to receive either atorvastatin 10 mg plus ezetimibe 10 mg (ATO10/EZE10) or atorvastatin 40 mg alone (ATO40). The intermediate lesions were evaluated using a near-infrared spectroscopy-intravascular ultrasonography at baseline and after 12 months in 37 patients. The primary endpoint was percent atheroma volume (PAV). Mean LDL-C levels were significantly reduced by 40% and 38% from baseline in the ATO10/EZE10 group (n = 18, from 107 mg/dL to 61 mg/dL) and ATO40 group (n = 19, from 101 mg/dL to 58 mg/dL), respectively, without between-group difference. The absolute change of PAV was -2.9% in the ATO10/EZE10 group and -3.2% in the ATO40 group. The mean difference (95% confidence interval) for the absolute change in PAV between the 2 groups was 0.5% (-2.4% to 2.8%), which did not exceed the pre-defined non-inferiority margin of 5%. There was no significant reduction in lipid core burden index in both groups. In conclusion, the combination of atorvastatin 10 mg and ezetimibe 10 mg showed comparable LDL-C lowering and regression of coronary atherosclerosis in the intermediate lesions, compared with atorvastatin 40 mg alone.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am J Cardiol: 04 Jul 2021; epub ahead of print

Long-Term Effects of an Intensive Prevention Program After Acute Myocardial Infarction.

Osteresch R, Fach A, Frielitz FS, Meyer S, ... Hambrecht R, Wienbergen H
Effective long-term prevention after myocardial infarction (MI) is crucial to reduce recurrent events. In this study the effects of a 12-months intensive prevention program (IPP), based on repetitive contacts between non-physician \"prevention assistants\" and patients, were evaluated. Patients after MI were randomly assigned to the IPP versus usual care (UC). Effects of IPP on risk factor control, clinical events and costs were investigated after 24 months. In a substudy efficacy of short reinterventions after more than 24 months (\"Prevention Boosts\") was analyzed. IPP was associated with a significantly better risk factor control compared to UC after 24 months and a trend towards less serious clinical events (12.5% vs 20.9%, log-rank p = 0.06). Economic analyses revealed that already after 24 months cost savings due to event reduction outweighted the costs of the prevention program (costs per patient 1,070 € in IPP vs 1,170 € in UC). Short reinterventions (\"Prevention Boosts\") more than 24 months after MI further improved risk factor control, such as LDL cholesterol and blood pressure lowering. In conclusion, IPP was associated with numerous beneficial effects on risk factor control, clinical events and costs. The study thereby demonstrates the efficacy of preventive long-term concepts after MI, based on repetitive contacts between non-physician coworkers and patients.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am J Cardiol: 04 Jul 2021; epub ahead of print

Comparison of Long-Term Outcomes in Men versus Women Undergoing Percutaneous Coronary Intervention.

Murphy AC, Dinh D, Koshy AN, Lefkovits J, ... Yudi MB, Victorian Cardiac Outcomes Registry
There has been a significant decrease in mortality associated with coronary artery disease (CAD) in recent decades, although at discordant rates between men and women. Using a well-established multicenter registry, we sought to examine the impact of gender on long-term mortality stratified by indication for percutaneous coronary intervention (PCI). Data from 54,440 consecutive patients (12,805, 23.5% women) undergoing PCI from the Victorian Cardiac Outcomes Registry (2013 to 2018) were analyzed. We aimed to compare gender-related differences of patients undergoing PCI for stable angina pectoris (SAP), non-ST-elevation acute coronary syndrome (NSTEACS) and ST-elevation myocardial infarction (STEMI). The primary outcome was long-term all-cause mortality. Female patients were older across all indications (SAP: 67 vs 71 years, NSTEACS: 64 vs 69 years, STEMI 61 vs 67 years; p value for all <0.001), with age-adjusted higher rates of diabetes mellitus (p value for all <0.02) and renal impairment (p value for all <0.001), and were more likely to have femoral artery access for intervention (p value for all <0.001). Unadjusted in-hospital and 30-day mortality rates were comparable between men and women across all indications. Compared to men, women had a higher rate of unadjusted long-term mortality (9.0% vs 7.37%; p <0.001). However, after adjusting for variables significant on univariate analysis, female gender was independently associated with improved long-term survival (HR 0.76, 95% CI 0.66 to 0.87; p <0.001). In conclusion, contrary to previous studies, despite being older with a differing clinical profile and interventional approach, women undergoing PCI have a long-term survival advantage.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am J Cardiol: 04 Jul 2021; epub ahead of print

Comparison of Long-Term Outcomes Following Coronary Revascularization in Men-vs-Women with Unprotected Left Main Disease.

Park S, Ahn JM, Park H, Kang DY, ... Park SJ, IRIS-MAIN Registry Investigators
Gender differences have been recognized in several aspects of coronary artery disease (CAD). However, evidence for gender differences in long-term outcomes after left main coronary artery (LMCA) revascularization is limited. We sought to evaluate the impact of gender on outcomes after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for unprotected LMCA disease. We evaluated 4,320 patients with LMCA disease who underwent CABG (n = 1,456) or PCI (n = 2,864) from the Interventional Research Incorporation Society-Left MAIN Revascularization registry. The primary outcome was a composite of death, myocardial infarction (MI), or stroke. Among 4,320 patients, 968 (22.4%) were females and 3,352 (77.6%) were males. Compared to males, females were older, had a higher prevalence of hypertension and insulin-requiring diabetes, more frequently presented with acute coronary syndrome, but had less extensive CAD and less frequent left main bifurcation involvement. The adjusted risk for the primary outcome was not different after PCI or CABG in females and males (hazard ratio [HR] 1.09; 95% confidence interval [CI]: 0.73-1.63 and HR 0.97; 95% CI: 0.80-1.19, respectively); there was no significant interaction between gender and the revascularization strategy (P for interaction = 0.775). In multivariable analysis, gender did not appear to be an independent predictor for the primary outcome. In revascularization for LMCA disease, females and males had a comparable primary composite outcome of death, MI, or stroke with either CABG or PCI without a significant interaction of gender with the revascularization strategy.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am J Cardiol: 03 Jul 2021; epub ahead of print

Relation between Modified Body Mass Index and Adverse Outcomes after Aortic Valve Implantation.

Driggin E, Gupta A, Madhavan MV, Alu M, ... Leon MB, Green P
We aimed to investigate the relationship of modified body mass index (mBMI), the product of BMI and serum albumin, with survival after transcatheter (TAVI) and surgical aortic valve implantation (SAVI). Frailty is associated with poor outcomes after TAVI and SAVI for severe aortic stenosis (AS). However, clinical frailty is not routinely measured in clinical practice due to the cumbersome nature of its assessment. Modified BMI is an easily measurable surrogate for clinical frailty that is associated with survival in elderly cohorts with non-valvular heart disease. We utilized individual patient-level data from a pooled database of the Placement of Aortic Transcatheter Valves (PARTNER) trials from the PARNTER1, PARTNER2 and S3 cohorts. We estimated cumulative mortality at 1 year for quartiles of mBMI with the Kaplan-Meier method and compared them with the log-rank test. We performed Cox proportional hazards modeling to assess the association of mBMI strata with 1-year mortality adjusting for baseline clinical characteristics. A total of 6593 patients who underwent TAVI or SAVI (mean age 83±7.3 years, 57% male) were included. mBMI was independently associated with all-cause one-year mortality with the lowest mBMI quartile as most predictive (HR 2.33, 95% CI 1.80-3.02, p < 0.0001). Notably, mBMI performed as well as clinical frailty index to predict 1-year mortality in this cohort. In conclusion, modified BMI predicts 1-year survival after both TAVI and SAVI. Given that it performed similar to the clinical frailty index, it may be used as a clinical tool for assessment of frailty prior to valve implantation.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am J Cardiol: 29 Jun 2021; epub ahead of print

Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (The EXACT Trial): Rationale, Design, and Clinical Considerations.

Povsic TJ, Henry TD, Ohman EM, Pepine CJ, ... Answini GA, Mokadam NA
Background
Patients with refractory angina (RA) have poor quality of life and new therapies are needed. XC001 is a novel adenoviral vector expressing multiple isoforms of vascular endothelial growth factor (VEGF) promoting an enhanced local angiogenic effect.
Methods
The Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (EXACT) trial is a 6-month (with 6-month extension) phase 1/2, first-in-human, multicenter, open-label, single-arm, dose-escalation study to evaluate the safety, tolerability, and preliminary efficacy of XC001 in patients with RA. The trial will enroll 33 patients in an initial (n=12) ascending dose-escalation phase (1 × 10⁹, 1 × 10¹⁰, 4 × 10¹⁰, and 1 × 10¹¹ viral particles), followed by phase 2 (n=21) assessing the highest tolerated dose. Patients must have stable Canadian Cardiovascular Society (CCS) class II-IV angina on maximally tolerated medical therapy without options for conventional revascularization, demonstrable ischemia on stress testing, and angina limiting exercise tolerance. XC001 will be delivered directly to ischemic myocardium via surgical transthoracic epicardial access. The primary outcome is safety via adverse event monitoring through 6 months. Efficacy assessments include difference from baseline to month 6 in time to 1 mm of ST segment depression, time to angina, and total exercise duration; myocardial blood flow at rest, and stress and coronary flow reserve by positron emission tomography; quality of life; CCS functional class; and angina frequency.
Conclusions
The EXACT trial will determine whether direct intramyocardial administration of XC001 in patients with RA is safe and evaluate its effect on exercise tolerance, myocardial perfusion, angina and physical activity, informing future clinical investigation.
Clinical trial registration
NCT04125732.

Copyright © 2021. Published by Elsevier Inc.

Am Heart J: 01 Jul 2021; epub ahead of print

Effect of Lipoprotein (a) Levels on Long-term Cardiovascular Outcomes in Patients with Myocardial Infarction with Nonobstructive Coronary Arteries.

Gao S, Ma W, Huang S, Lin X, Yu M
The association between elevated lipoprotein(a) [Lp(a)] and poor outcomes in coronary artery disease (CAD) has been addressed for decades. However, little is known about the prognostic value of Lp(a) in patients with myocardial infarction with nonobstructive coronary arteries (MINOCA). A total of 1179 patients with MINOCA were enrolled and divided into low, medium, and high Lp(a) groups based on the cut-off value of 10 and 30mg/dL. The primary endpoint was major adverse cardiovascular events (MACE), a composite of all-cause death, nonfatal MI, nonfatal stroke, revascularization, and hospitalization for unstable angina or heart failure. Kaplan-Meier and Cox regression analyses were performed. Accuracy was defined as area under the curve (AUC) using a receiver-operating characteristic analysis. Patients with higher Lp(a) levels had a significantly higher incidence of MACE (9.5%, 14.6%, 18.5%; p = 0.002) during the median follow-up of 41.7 months. The risk of MACE also increased with the rising Lp(a) levels even after multivariate adjustment [low Lp(a) group as reference, medium group: hazard ratio (HR) 1.55, 95% confidence interval (CI): 1.02-2.40, p = 0.047; high group: HR 2.07, 95% CI: 1.32-3.25, p = 0.001]. Further, clinically elevated Lp(a) defined as Lp(a) ≥30 mg/dL was closely associated with an increased risk of MACE in overall and in subgroups (all p <0.05). When adding Lp(a) (AUC 0.61) into the Thrombolysis in Myocardial Infarction (TIMI) score (AUC 0.68), the combined model (AUC 0.73) yielded a significant improvement in discrimination for MACE (ΔAUC 0.05, p = 0.032). In conclusion, elevated Lp(a) was strongly associated with a poor prognosis in patients with MINOCA. Adding Lp(a) to traditional risk score further improved risk prediction. Our data, for the first time, confirmed the Lp(a) as a residual risk factor for MINOCA.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am J Cardiol: 31 Jul 2021; 152:34-42

Seattle Angina Pectoris Questionnaire and Canadian Cardiovascular Society Angina Categories in the Assessment of Total Coronary Atherosclerotic Burden.

Guimarães WVN, Nicz PFG, Garcia-Garcia HM, Abizaid A, ... Filho RK, Campos CM
The patient reported angina measurement with the Seattle Angina Questionnaire (SAQ) has shown to have prognostic implications and became an endpoint in clinical trials. Our objective was to study physician-reported and SAQ severity with the total coronary atherosclerotic burden as assessed by 4 angiographic scores. We prospectively analyzed data of consecutive patients scheduled for coronary angiography or percutaneous coronary intervention. The Canadian Cardiovascular Society (CCS) angina categories was used as physician-reported angina. SAQ domains were categorized as severe (0 to 24), moderate 25 to 75 and mild angina (>75). All angina assessments were done before coronary angiography. Gensini, Syntax, Friesinger, and Sullivan angiographic scores were used for total atherosclerotic burden quantification: 261 patients were included in the present analysis. The median age was 66.0 (59.0 to 71.8) years, 53.6% were male and 43.7% had diabetes. The median SYNTAX score was 6.0 (0 to 18.0). The worse the symptoms of CCS categories, the more severe was the atherosclerotic burden in all angiographic scores: SYNTAX (p = 0.01); Gensini (p <0.01); Friesinger (p = 0.02) and Sullivan (p = 0.03). Conversely, SAQ domains were not able to discriminate the severity of CAD in any of the scores. The only exception was the severe SAQ quality of life that had worse Gensini score than the mild SAQ quality of life (p = 0.04). In conclusion, CCS angina categories are related to the total atherosclerotic burden in coronary angiography, by all angiographic scores. SAQ domains should be used as a measure of patient functionality and quality of life but not as a measure of CAD severity.

Copyright © 2021. Published by Elsevier Inc.

Am J Cardiol: 31 Jul 2021; 152:43-48

Effects of the PCSK9 antibody alirocumab on coronary atherosclerosis in patients with acute myocardial infarction: a serial, multivessel, intravascular ultrasound, near-infrared spectroscopy and optical coherence tomography imaging study-Rationale and design of the PACMAN-AMI trial.

Zanchin C, Koskinas KC, Ueki Y, Losdat S, ... Windecker S, Räber L
Background
The risk for cardiovascular adverse events after acute myocardial infarction (AMI) remains high despite potent medical treatment including low-density lipoprotein cholesterol (LDL-C) lowering with statins. Proprotein convertase subtilisin/kexin type 9 (PCSK9) antibodies substantially reduce LDL-C when added to statin. Alirocumab, a monoclonal antibody to PCSK9, reduces major adverse cardiovascular events after AMI. The effects of alirocumab on coronary atherosclerosis including plaque burden, plaque composition and fibrous cap thickness in patients presenting with AMI remains unknown.
Aims
To determine the effect of LDL-C lowering with alirocumab on top of high-intensity statin therapy on intravascular ultrasound (IVUS)-derived percent atheroma volume (PAV), near-infrared spectroscopy (NIRS)-derived maximum lipid core burden index within 4 mm (maxLCBI_{4 mm}) and optical coherence tomography (OCT)-derived fibrous cap thickness (FCT) in patients with AMI.
Methods
In this multicenter, double-blind, placebo-controlled trial, 300 patients with AMI (ST-elevation or non-ST-elevation myocardial infarction) were randomly assigned to receive either biweekly subcutaneous alirocumab (150 mg) or placebo beginning <24 hours after the acute event as add-on therapy to rosuvastatin 20 mg. Patients undergo serial IVUS, NIRS and OCT in the two non-infarct related arteries at baseline (at the time of treatment of the culprit lesion) and at 52 weeks. The primary endpoint, change in IVUS-derived PAV, and the powered secondary endpoints, change in NIRS-derived maxLCBI_{4 mm}, and OCT-derived minimal FCT, will be assessed 52 weeks post randomization.
Summary
The PACMAN-AMI trial will determine the effect of alirocumab on top of high-intensity statin therapy on high-risk coronary plaque characteristics as assessed by serial, multimodality intracoronary imaging in patients presenting with AMI.
Clinical trial registration
NCT03067844.

Copyright © 2021. Published by Elsevier Inc.

Am Heart J: 30 Jul 2021; 238:33-44

Cangrelor vs. glycoprotein IIb/IIIa inhibitors during percutaneous coronary intervention.

Yerasi C, Case BC, Chezar-Azerrad C, Forrestal BJ, ... Garcia-Garcia HM, Waksman R
Background
To date, there are no real-world studies comparing cangrelor to glycoprotein IIb/IIIa inhibitors (GPI) during percutaneous coronary intervention (PCI). Thus, we performed this study to evaluate the safety and effectiveness of cangrelor compared to GPI during PCI.
Methods
We identified patients who underwent PCI at our institution who received either cangrelor or GPI during PCI. Patients already on GPI or cangrelor prior to PCI or who received both cangrelor and GPI were excluded. Baseline demographics and clinical outcomes were extracted. Major bleeding is defined as a composite of major hematoma >4 cm, hematocrit drop >15, and gastrointestinal bleeding.
Results
A total of 2072 patients received adjunctive antiplatelet therapy during PCI (cangrelor [n=478]; GPI [n=1594]). Patients\' mean age was 61±12 years. Most (66%) presented with acute coronary syndrome. Patients who received cangrelor were older and had a higher percentage of acute coronary syndrome and lower baseline hematocrit in comparison with patients who received GPI. Procedural success was achieved in 94% of patients, with no difference between groups. Major bleeding events (1.7% vs. 5.1%, P=.001), any vascular complication rates, and hospital length of stay were significantly lower in the cangrelor group. In-hospital ischemic events did not differ between groups. On regression analysis, patients on cangrelor were noted to have significantly lower major bleeding events (OR 0.23; 95% CI, 0.09-0.59).
Conclusions
Balancing ischemic and bleeding risks with adjunctive antiplatelet drugs is of prime importance during PCI. Our real-world analysis shows that cangrelor is safe and effective when compared to GPI during PCI.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am Heart J: 30 Jul 2021; 238:59-65

Hospital Readmission in Patients With Spontaneous Coronary Artery Dissection.

Krittanawong C, Yue B, Mahtta D, Kumar A, ... Jneid H, Bhatt DL
Spontaneous coronary artery dissection (SCAD) can present with various clinical symptoms, including chest pain, syncope, and sudden cardiac death, particularly in those without atherosclerotic risk factors. In this contemporary analysis, we aimed to identify the causes and predictors of 30-day hospital readmission in SCAD patients. We utilized the latest Nationwide Readmissions Database from 2016 - 2017 to identify patients with a primary discharge diagnosis of SCAD. The primary outcome was 30-day readmission. Among 795 patients admitted with a principal discharge diagnosis of SCAD, 85 (11.3%) were readmitted within 30 days of discharge from index admission (69.8% women, mean age of 54.3 ± 0.8). More than half of the readmissions (57%) were cardiac-related readmissions. Common cardiac causes for 30-day hospital readmission were acute coronary syndrome (27.3%), chest pain/unspecified angina (24.6%), heart failure (17.5%), and recurrent SCAD (8.3%). In conclusion, we found that following hospitalization for SCAD, almost one-tenth of patients were readmitted within 30 days, largely due to cardiac cause . Risk stratifying patients with SCAD, identifying high-risk features or atypical phenotypes of SCAD, and using appropriate management strategies may prevent hospital readmissions and reduce healthcare-related costs. Further studies are warranted to confirm these causes of readmission in SCAD patients.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am J Cardiol: 14 Jul 2021; 151:39-44

One-Year Outcomes After Treatment of Ostial In-Stent Restenosis in Left Circumflex Versus Left Anterior Descending or Right Coronary Artery.

Chezar-Azerrad C, Musallam A, Shea C, Zhang C, ... Mintz GS, Waksman R
The prognosis of left circumflex (LC) versus non-LC in-stent restenosis (ISR) ostial lesions following treatment has not been assessed. We aimed to assess this prognosis. Anecdotally, treatment of ostial LC ISR has been associated with high recurrence rates. We performed a retrospective analysis of patients from our institution who underwent coronary intervention of an ostial ISR lesion between 2003 and 2018. The primary endpoint was target lesion revascularization (TLR) and major adverse cardiovascular events (MACE). Overall, 563 patients underwent ostial ISR lesion intervention, 144 for an ostial LC ISR lesion. Compared to patients with ostial ISR in non-LC lesions, patients with ostial LC ISR were older, had higher rates of diabetes mellitus and previous coronary bypass surgery. At 1-year follow-up, TLR-MACE rates were 26.6% in the LC group versus 18.4% in the non-LC group (p = 0.036). The TLR rate was also higher in the LC group compared to the non-LC group (p = 0.0498). Univariate and multivariate analyses demonstrated a higher TLR-MACE rate for LC versus non-LC ostial ISR lesions. In conclusion, our study shows increased event rates after treatment of LC versus non-LC ISR lesions. Further studies should be done to assess the optimal treatment approach for ostial LC ISR.

Copyright © 2021. Published by Elsevier Inc.

Am J Cardiol: 14 Jul 2021; 151:45-50

Simplifying the ISCHEMIA trial algorithm for clinical practice: Identifying left main coronary artery disease using coronary artery calcium scans.

Money JE, Muhlestein JB, Mason S, Bair TL, ... Horne BD, Anderson JL
Background
Several recent trials have evaluated invasive versus medical therapy for stable ischemic heart disease. Importantly, patients with significant left main coronary stenosis (LMCS) were excluded from these trials. In the ISCHEMIA trial, these patients were identified by a coronary CT angiogram (CCTA), which adds time, expense, and contrast exposure. We tested whether a coronary artery calcium scan (CACS), a simpler, less expensive test, could replace CCTA to exclude significant LMCS.
Methods
We hypothesized that patients with ≥50% LMCS would have a LM CACS score > 0. As a corollary, we postulated that a LM CACS = 0 would exclude patients with LMCS. To test this, we searched Intermountain Healthcare\'s electronic medical records database for all adult patients who had undergone non-contrast cardiac CT for quantitative CACS scoring prior to invasive coronary angiography (ICA). Patients aged <50 and those with a heart transplant were excluded. Cases with incomplete (qualitative) angiographic reports for LMCS and those with incomplete or discrepant LM CACS results were reviewed and reassessed blinded to CACS or ICA findings, respectively.
Results
Among 669 candidate patients with CACS followed by ICA, 36 qualifying patients were identified who had a quantitative CACS score and LMCS ≥ 50%. Their age averaged 71.8 years, and 81% were men. Angiographic LMCS averaged 72% (range 50%-99%). Median time between CACS and ICA was 6 days. Total CACS score averaged 2,383 Agatston Units (AU), range 571-6,636. LM CACS score averaged 197 AU, range 31-610. Importantly, no LMCS patient had a LM CACS score of 0 vs 57% (362/633) of non-LMCS controls (P < .00001).
Conclusions
Our results support the hypothesis that an easily administered, inexpensive, low radiation CACS can identify a large subset of patients with a very low risk of LMCS who would not have the need for routine CCTA. Using CACS to exclude LMCS may efficiently allow for safe implementation of an initial medical therapy strategy of patients with stable ischemic heart disease in clinical practice. These promising results deserve validation in larger data sets.

Copyright © 2021. Published by Elsevier Inc.

Am Heart J: 30 Aug 2021; 239:129-134

Impact of Body Composition Indices on Ten-year Mortality After Revascularization of Complex Coronary Artery Disease (From the Syntax Extended Survival Trial).

Ono M, Kawashima H, Hara H, O\'Leary N, ... Onuma Y, Serruys PW
Numerous studies have demonstrated a paradoxical association between higher baseline body mass index (BMI) and lower long-term mortality risk after coronary revascularization, known as the \"obesity paradox\", possibly relying on the single use of BMI. The current study is a post-hoc analysis of the SYNTAX Extended Survival (SYNTAXES) trial, which is the extended follow-up of the SYNTAX trial comparing percutaneous coronary intervention (PCI) versus coronary artery bypass graft (CABG) in patients with left-main coronary artery disease (LMCAD) or three-vessel disease (3VD). Patients were stratified according to baseline BMI and/or waist circumference (WC). Out of 1,800 patients, 1,799 (99.9%) and 1,587 (88.2%) had available baseline BMI and WC data, respectively. Of those, 1,327 (73.8%) patients had High BMI (≥25 kg/m²), whereas 705 (44.4%) patients had High WC (>102 cm for men or >88 cm for women). When stratified by both BMI and WC, 10-year mortality risk was significantly higher in patients with Low BMI/Low WC (adjusted hazard ratio [HR]: 1.65; 95% confidence interval [CI]: 1.09 to 2.51), Low BMI/ High WC (adjusted HR: 2.74; 95% CI: 1.12 to 6.69), or High BMI/High WC (adjusted HR: 1.59; 95% CI: 1.11 to 2.27) compared to those with High BMI/Low WC. In conclusion, the \"obesity paradox\" following coronary revascularization would be driven by low long-term mortality risk of the High BMI/Low WC group. Body composition should be assessed by the combination of BMI and WC in the appropriate evaluation of the long-term risk of obesity in patients with LMCAD or 3VD.

Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.

Am J Cardiol: 14 Jul 2021; 151:30-38

Meta-Analysis Comparing the Effect of Combined Omega-3 + Statin Therapy Versus Statin Therapy Alone on Coronary Artery Plaques.

Fan H, Zhou J, Yuan Z
Statin therapy plays an important role in stabilizing and regressing coronary artery plaques. Omega-3 supplements also have anti-inflammatory and antioxidant effects on coronary plaques. However, the effect of omega-3 supplementation on the basis of statin therapy on the stability and composition of plaques, is still unclear. We searched for randomized controlled trials published prior to November 2020 in the PubMed, Embase and Cochrane databases. Finally, eight studies using different imaging techniques to evaluate coronary atherosclerotic plaque, including optical coherence tomography (OCT), coronary CT angiography (cCTA) and intravascular ultrasound (IB-IVUS), met our inclusion criteria. We pooled data extracted from the included studies using the standardized mean difference (SMD) or mean difference (MD) of the random effects model. Compared with statin treatment alone, the combined treatment further delayed the progression of total plaque volume [SMD -0.36, 95% confidence interval (CI) -0.64 to -0.08, p = 0.01] and fiber content (SMD -0.40, 95% CI -0.68 to -0.13, p = 0.004). The plasma high-sensitivity C-reactive protein (hs-CRP) level of patients in the combination treatment group was significantly lower than that of the patients in the statin treatment group alone (SMD -0.30, 95% CI -0.59 to -0.01, p = 0.04). In addition, the combined use of omega-3 further increases the fibrous cap thickness (FCT) of the plaque with an MD of 29.45 μm. There were no significant differences in plasma high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), or lipid content in plaques between the two groups. Omega-3 combined with statins is superior to the statin treatment group in stabilizing and promoting coronary plaque regression and may help to further reduce the occurrence of cardiovascular events.

Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.

Am J Cardiol: 14 Jul 2021; 151:15-24

Meta-Analysis of Duration of Dual Antiplatelet Therapy in Acute Coronary Syndrome Treated With Coronary Stenting.

Knijnik L, Fernandes M, Rivera M, Cardoso R, ... Sperling LS, McDaniel MC
We aimed to evaluate if a shorter course of DAPT followed by P2Y12 inhibitor monotherapy is as effective as a 12-month course with fewer bleeding events. PubMed, Scopus, and Cochrane Central were searched for randomized controlled trials of ACS patients comparing dual antiplatelet therapy (DAPT) for 1 to 3 months followed by a P2Y12 inhibitor to 12-month DAPT. Quality assessment was performed with the Cochrane Collaboration risk of bias assessment tool. Five randomized clinical trials were included, with a total of 18,046 participants. Antiplatelet strategies were aspirin and P2Y12 inhibitor for 12 months compared with aspirin and P2Y12 inhibitor for 1 to 3 months followed by P212 inhibitor alone. Patients randomized to 1 to 3 months of DAPT followed by P2Y12 inhibitor monotherapy had lower rates of major bleeding (1.42% vs 2.53%; OR 0.53; 95% CI 0.42-0.67; p < 0.001; I² = 0%) and all-cause mortality (1.00% vs 1.42%; OR 0.71; 95% CI 0.53-0.95; p = 0.02; I²=0%) with similar major adverse cardiac events (MACE) (2.66% vs 3.11%; OR 0.86; 95% CI 0.71 - 1.03; p = 0.10; I² = 0 %) compared to 12 months of DAPT. In conclusion, shorter course of DAPT for 1 to 3 months followed by P2Y12 inhibitor monotherapy reduces major bleeding and all course mortality without increasing major adverse cardiac events compared with traditional DAPT for 12 months.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am J Cardiol: 14 Jul 2021; 151:25-29

Usefulness of Adding Pre-procedural Glycemia to the Mehran Score to Enhance Its Ability to Predict Contrast-induced Kidney Injury in Patients Undergoing Percutaneous Coronary Intervention Development and Validation of a Predictive Model.

Nusca A, Mangiacapra F, Sticchi A, Polizzi G, ... Ussia GP, Grigioni F
The Mehran score is the most widely accepted tool for predicting contrast-induced acute kidney injury (CI-AKI), a major complication of percutaneous coronary intervention (PCI). Similarly, abnormal fasting pre-procedural glycemia (FPG) represents a modifiable risk factor for CI-AKI, but it is not included in current risk models for CI-AKI prediction. We sought to analyze whether adding FPG to the Mehran score improves its ability to predict CI-AKI following PCI. We analyzed 671 consecutive patients undergoing PCI (age 69 [63,75] years, 23% females), regardless of their diabetic status, to derive a revised Mehran score obtained by including FPG in the original Mehran score (Derivation Cohort). The new risk model (GlyMehr) was externally validated in 673 consecutive patients (Validation Cohort) (age 69 [62,76] years, 21% females). In the Derivation Cohort, both FPG and the original Mehran score predicted CI-AKI (AUC 0.703 and 0.673, respectively). The GlyMehr score showed a better predictive ability when compared with the Mehran score both in the Derivation Cohort (AUC 0.749, 95%CI 0.662 to 0.836; p = 0.0016) and the Validation Cohort (AUC 0.848, 95%CI, 0.792 to 0.903; p = 0.0008). In the overall population (n = 1344), the GlyMehr score confirmed its independent and incremental predictive ability regardless of diabetic status (p ≤0.0034) or unstable/stable coronary syndromes (p ≤0.0272). In conclusion, adding FPG to the Mehran score significantly enhances our ability to predict CI-AKI. The GlyMehr score may contribute to improve the clinical management of patients undergoing PCI by identifying those at high risk of CI-AKI and potentially detecting modifiable risk factors.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am J Cardiol: 16 Jul 2021; epub ahead of print

Impact of High Body Mass Index on Vascular and Bleeding Complications After Transcatheter Aortic Valve Implantation.

Berti S, Bartorelli AL, Koni E, Giordano A, ... Navarese EP, From the RISPEVA registry
Increased body mass index (BMI) is an established cardiovascular risk factor. The impact of high BMI on vascular and bleeding complications in patients undergoing transcatheter aortic valve implantation (TAVI) is not clarified. RISPEVA, a multicenter prospective database of patients undergoing TAVI stratified by BMI was used for this analysis. Patients were classified as normal or high BMI (obese and overweight) according to the World Health Organization criteria. A comparison of 30-day vascular and bleeding outcomes between groups was performed using propensity scores methods. A total of 3776 matched subjects for their baseline characteristics were included. Compared with normal BMI, high BMI patients had significantly 30-day greater risk of the composite of vascular or bleeding complications (11.1% vs 8.8%, OR: 1.28, 95% CI [1.02 to 1.61]; p = 0.03). Complications rates were higher in both obese (11.3%) and overweight (10.5%), as compared with normal weight patients (8.8%). By a landmark event analysis, the effect of high versus normal BMI on these complications appeared more pronounced within 7 days after the TAVI procedure. A significant linear association between increased BMI and vascular complications was observed at this time frame (p = 0.03). In conclusion, compared with normal BMI, both obese and overweight patients undergoing TAVI, experience increased rates of 30-day vascular and bleeding complications. These findings indicate that high BMI is an independent risk predictor of vascular and bleeding complications after TAVI.

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

Am J Cardiol: 16 Jul 2021; epub ahead of print

Impact of Mitral Annular Calcium and Mitral Stenosis on Outcomes After Transcatheter Aortic Valve Implantation.

Mesnier J, Urena M, Chong-Nguyen C, Fischer Q, ... Iung B, Himbert D
Mitral annular calcium (MAC) is a common finding in patients undergoing transcatheter aortic valve implantation (TAVI) and may be associated with mitral stenosis (MAC-MS). Their impact on post-TAVI outcomes remains controversial. We sought to assess the impact of MAC and MAC-MS on clinical outcomes following TAVI. We included 1,177 patients who consecutively underwent TAVI in our institution between January 2008 and May 2018. MAC diagnosis reposed on echocardiogram and computed tomography. The combination of MAC and a mean transmitral gradient ≥ 5 mmHg defined MAC-MS. The study included 1,177 patients, of whom 504 (42.8%) had MAC and 85 (7.2%) had MAC-MS. Patients with and without MAC had similar outcomes except for a higher rate of pacemaker implantation in MAC patients (adjusted HR: 1.32, 95% CI: 1.03-1.69, p = 0.03). The subgroup of patients with severe MAC had similar outcomes. However, MAC-MS was an independent predictor of all-cause mortality at 30 days (adjusted HR: 2.30, 95% CI: 1.08-4.86, p = 0.03) and 1 year (adjusted HR: 1.73, 95% CI: 1.04-2.89, p = 0.04). In conclusion, MAC is present in nearly half of the patients treated with TAVI but MAC-MS is far less frequent. In itself, even severe, MAC does not influence outcomes while MAC-MS is an independent predictor of all-cause 1-year mortality. Measurement of mean transmitral gradient identifies patients with MAC at high risk after TAVI.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am J Cardiol: 16 Jul 2021; epub ahead of print

Relation of the Number of Cardiovascular Conditions and Short-term Symptom Improvement After Percutaneous Coronary Intervention for Stable Angina Pectoris.

Flynn CR, Orkaby AR, Valsdottir LR, Kramer DB, ... Yeh RW, Strom JB
With aging of the population, cardiovascular conditions (CC) are increasingly common in individuals undergoing PCI for stable angina pectoris (AP). It is unknown if the overall burden of CCs associates with diminished symptom improvement after PCI for stable AP. We prospectively administered validated surveys assessing AP, dyspnea, and depression to patients undergoing PCI for stable AP at our institution, 2016-2018. The association of CC burden and symptoms at 30-days post-PCI was assessed via linear mixed effects models. Included individuals (N = 121; mean age 68 ± 10 years; response rate = 42%) were similar to non-included individuals. At baseline, greater CC burden was associated with worse dyspnea, depression, and physical limitations due to AP, but not AP frequency or quality of life. PCI was associated with small improvements in AP and dyspnea (p ≤ 0.001 for both), but not depression (p = 0.15). After multivariable adjustment, including for baseline symptoms, CC burden was associated with a greater improvement in AP physical limitations (p = 0.01) and depression (p = 0.002), albeit small, but not other symptom domains (all p ≥ 0.05). In patients undergoing PCI for stable AP, increasing CC burden was associated with worse dyspnea, depression, and AP physical limitations at baseline. An increasing number of CCs was associated with greater improvements, though small, in AP physical limitations and depression. In conclusion, the overall number of cardiovascular conditions should not be used to exclude patients from PCI for stable AP on the basis of an expectation of less symptom improvement.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am J Cardiol: 16 Jul 2021; epub ahead of print

Fractional flow reserve guided versus angiographic guided surgical revascularization: A meta-analysis.

Bruno F, D\'Ascenzo F, Marengo G, Manfredi R, ... Rinaldi M, De Ferrari GM
Background
Clinical benefits of FFR (Fraction Flow Reserve) driven CABG (Coronary Artery Bypass Graft) remain to be established.
Methods
All randomized controlled trials (RCTs) and observational studies with multivariable adjustement were included. MACE (Major Adverse Cardiac Events) was the primary end point, while its single components (death, myocardial infarction, and total vessel revascularization [TVR]) along with number of anastomoses, on pump procedures and graft occlusion at angiographic follow-up were the secondary ones. Each analysis was stratified for RCTs versus observational studies.
Results
Four studies (two RCTs and two observational) were included, enrolling 983 patients, 542 angio-guided and 441 FFR-guided. Mean age was 68.45 years, 79% male, with a mean EuroSCORE I of 2.7. Coronary lesions were located in 37% of patients in the left anterior descending artery, 32% in the circumflex artery, and 26% in the right coronary artery. After a mean follow-up of 40 months, risk of MACE did not differ (OR 0.86 [0.63-1.18]) as that of all cause death (OR 0.86 [0.59-1.25]), MI (OR 0.57 [0.30-1.11]) and TVR (OR 1.10 [0.65-1.85]). FFR-driven CABG reduced on-pump procedures (OR 0.58 [0.35-0.93]) and number of anastomoses (-0.40 [-0.80: -0.01]) while incidence of graft occlusion at follow-up did not differ (OR 0.59 [0.30-1.15], all CI 95%).
Conclusion
Fraction flow reserve driven CABG reduced the number of anastomoses and of on-pump procedures without increasing risk of MACE and without reducing graft occlusion at angiographic follow-up. ID CRD42020211945.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:E18-E23

Association between mid-term worsening renal function and mortality after transcatheter aortic valve replacement in patients with chronic kidney disease.

Phan DQ, Lee MS, Aharonian V, Mansukhani P, ... Brar SS, Zadegan R
Introduction
Chronic kidney disease (CKD), acute kidney injury (AKI) and worsening renal function at 30 days after transcatheter aortic valve replacement (TAVR) portend poor outcomes. We sought to evaluate the association between worsening renal function at 3-6 months and mortality among patients with baseline renal dysfunction undergoing TAVR.
Methods
This is a retrospective study of patients with glomerular filtration rate (GFR) < 60 ml/min undergoing TAVR between June 2011 and March 2019 at the Regional Cardiac Catheterization Lab at Kaiser Permanente Los Angeles. Worsening renal function at 3-6 months post-TAVR was defined as: increase in serum creatinine >1.5 times compared to baseline, absolute increase of ≥0.3 mg/dl, or initiation of dialysis.
Results
Of 683 patients reviewed, 176 were included in the analysis (median age 84 [IQR 79-88] years, 56% female). Of these, 27 (15.3%) had worsening renal function. AKI post-TAVR (OR 2.9, 95% CI 1.1-7.4, p = .03) and transfusion of ≥4 units red blood cells (OR 8.4, 95% CI 1.2-59, p = .03) were independent predictors of worsening renal function. Worsening renal function increased risk for mortality (HR 2.2, 95% CI 1.17-4.27, p = .015) at a median follow-up of 691 days. Those with improved/stable function with baseline GFR < 60 ml/min had comparable mortality risk to those with baseline GFR ≥ 60 ml/min (18% vs. 16.5%; HR 1.1, 95% CI 0.72-1.75, p = .62).
Conclusion
Among patients with baseline renal dysfunction, only 15% developed worsening renal function at 3-6 months after TAVR, which was associated with increased mortality. Predictors for worsening renal function include AKI and blood transfusions. Preventative measures peri-procedurally and continued monitoring post-discharge are warranted to improve outcomes.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:185-194

Optical coherence tomography analysis of late lumen enlargement after paclitaxel-coated balloon angioplasty for de-novo coronary artery disease.

Sogabe K, Koide M, Fukui K, Kato Y, ... Nakamura T, Matoba S
Background
Paclitaxel-coated balloon angioplasty for de-novo coronary artery lesions causes late lumen enlargement (LLE), however, the mechanisms and predictors of LLE have not been elucidated.
Methods and results
We retrospectively analyzed 91 consecutive patients with 95 de-novo coronary lesions, who underwent paclitaxel-coated balloon angioplasty without stenting from August 2018 to July 2019 as well as follow-up coronary angiography and optical coherence tomography (OCT). The mean follow-up duration was 8.2 ± 2.9 months. The target lesion revascularization rate was 7.3%. OCT demonstrated LLE in 50.5% of lesions. The lesions with LLE had a higher incidence of vessel enlargement (76.6 vs. 29.2%, p < .01), regression of plaque or dissection flap (55.3 vs. 10.4%, p < 0.01; 40.4 vs. 14.6%, p < .01, respectively), and reattachment and healing of dissection flaps (74.5 vs. 27.1%, p < .01) compared with those without LLE. Preprocedure thick-cap fibroatheroma plaques and postprocedure deep dissection reaching the tunica media were positive predictors of LLE (hazard ratio, HR 3.74 [1.93-7.25], p < .001; HR 2.04 [1.02-4.05], p < .05, respectively).
Conclusions
OCT analysis after paclitaxel-coated balloon treatment of de-novo coronary artery lesions revealed that the mechanism of LLE was associated with vessel enlargement, healing of dissection flaps, and regression of plaque or dissection flap. Preprocedure thick-cap fibroatheroma plaques and postprocedure deep dissection reaching the tunica media on OCT were predictors of LLE.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:E35-E42

Clinical impact of bifurcation angle change between diastole and systole in complex stenting for left main distal bifurcation: The Milan and New-Tokyo (MITO) Registry.

Watanabe Y, Mitomo S, Naganuma T, Takagi K, ... Nakamura S, Colombo A
Objectives
We assessed the impact of pre-percutaneous coronary intervention (PCI) bifurcation angle change (BAC) on clinical outcomes.
Background
There are little available data about the impact of BAC in unprotected left main distal bifurcation lesions (ULMD) PCI.
Methods
We identified consecutive 300 patients with ULMD underwent complex stenting using drug-eluting stent in three high-volume centers (Tokyo and Milan). We measured the widest BA of ULMD at both end-diastole and end-systole before stenting with two-dimensional quantitative coronary angiographic assessment and calculated the BAC value as a difference of two BA value in each lesion. We divided them into small and large BAC group according to the median BAC value (7.2°). The primary endpoint was target lesion failure (TLF), which was defined as a composite of cardiac death, target lesion revascularization (TLR) and myocardial infarction.
Results
TLF rate at 3-year was significantly higher in the large BAC group than in the small BAC group (adjusted hazard ratio [HR] 5.85; 95% confidence interval [CI], 3.40-10.1; p < .001). TLR rate for left main (LM) to left anterior descending artery (LAD) and ostial left circumflex artery (LCXos) at 3-year were significantly higher in large BAC group than in small BAC group (adjusted HR 5.91; 95% CI, 2.03-17.2; p = .001 and adjusted HR 10.6; 95% CI, 5.20-21.6; p < .001, respectively).
Conclusions
A large BAC before stenting is strongly associated with adverse events after complex stenting for ULMD, mainly driven by repeat PCI for restenosis of the LCXos and of the LM-LAD.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:E24-E34

Ability of a novel shock index that incorporates invasive hemodynamics to predict mortality in patients with ST-elevation myocardial infarction.

McKenzie A, Zhou C, Svendsen C, Anketell R, ... Yeung M, Stouffer GA
Objective
To determine whether the use of invasively measured hemodynamics improves the prognostic ability of a shock index (SI).
Background
SI such as Admission-SI, Age-SI, Modified SI (MSI), and Age-MSI predict short-term mortality in ST-elevation myocardial infarction (STEMI).
Methods
Single-center study of 510 patients who underwent primary percutaneous coronary intervention. STEMI SI was defined as age × heart rate (HR) divided by coronary perfusion pressure (CPP).
Results
The mean age was 62 ± 14 years, 66% were males with hypertension (69%), tobacco use (38%), diabetes (28%) and chronic kidney disease (6%). The mean HR, systolic blood pressure (SBP), and CPP were 81 ± 18 bpm, 124 ± 28 mmHg, and 52.8 ± 16.3 mmHg, respectively. Patients with STEMI SI ≥182 (n = 51) were more likely to experience a cardiac arrest in the catheterization laboratory (9.8% vs. 2.0%; p = .001), require mechanical circulatory support (47.1% vs. 8.5%; p < .0001) and be treated with vasopressors (56.9% vs. 10.7%; p < .0001) compared to STEMI SI < 182 (n = 459). After multivariate adjustment, patients with STEMI SI ≥182 were 10, 10.1 and 4.8 times more likely to die during hospitalization, at 30 days and at 5 years, respectively. The C statistic of STEMI SI was 0.870, similar to GRACE score (AUC = 0.902; p = .29) and TIMI STEMI score (AUC = 0.895; p = .36).
Conclusion
STEMI SI is an easy to calculate risk score that identifies STEMI patients at high risk of in-hospital death.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:87-94

Procedural optimization of drug-coated balloons in the treatment of coronary artery disease.

Lee HS, Kang J, Park KW, Ki YJ, ... Koo BK, Kim HS
Objectives
This study aimed to investigate the effects of procedural optimization on the clinical outcomes of using the drug-coated balloon (DCB) in the treatment of coronary artery disease.
Backgrounds
Procedural optimization is considered an essential step in DCB treatment.
Methods
Data of consecutive patients who underwent DCB treatment at the Seoul National University Hospital were collected. The primary outcome was target lesion failure (TLF) at 2 years.
Results
Among 259 patients (309 lesions), TLF was observed in 31 (12.0%) patients. The following were modifiable procedural factors: residual percent diameter stenosis (%DS) after lesion preparation; DCB-to-vessel/stent ratio; time-delay to inflation; and total DCB inflation time. The best cutoff values for these parameters were 20%, 0.95, 25, and 60 s, respectively. The patients were classified based on the number of procedural factors that satisfied adequate criteria. TLF was observed in 7.3% in the fully optimized group, 9.1% in the partially optimized group, and 34.1% in the nonoptimized group over 2 years (p < .001). The adequacy of the four factors for DCB optimization was an independent predictor of TLF (adjusted hazards ratio for each unmet criteria for optimization, 2.05, 95% confidence interval 1.74-2.36, p < .001).
Conclusion
The optimization of the four procedural factors could reduce TLF following DCB treatment.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:E43-E52

Sex-specific in-hospital outcomes of transcatheter aortic valve replacement with third generation transcatheter heart valves.

Simard T, Alqahtani F, Hibbert B, Mamas MA, ... Hohmann SF, Alkhouli M
Background
Sex-based differences in transcatheter aortic valve replacement (TAVR) outcomes have been previously documented. However, whether these differences persist with contemporary third generation transcatheter heart valves (THVs) is unknown.
Methods
We utilized Vizient\'s clinical database/resource manager (CDB/RM™) to identify patients who underwent TAVR between January 1, 2018 and March 31, 2020 to compare in-hospital outcomes between males and females. The primary endpoint was in-hospital mortality. Secondary endpoints included key in-hospital complications, length of stay, discharge disposition, and cost. Unadjusted, propensity-score matched and risk-adjusted analyses of outcomes were performed.
Results
During the study period, 44,280 patients (24,842 males, 19,438 females) underwent TAVR. The primary endpoint of in-hospital mortality was higher in females than in males (1.6 vs. 1.1% p < .001) in unadjusted analysis and persisted following propensity matching (1.6 vs. 0.9%, p < .001) and multivariable logistic regression with various risk-adjustment models. In the most comprehensive model adjusting for age, race, and clinical comorbidities, female sex was associated with 34% greater odds of in-hospital death (95% CI 20-50%, p < .001). Unadjusted and risk-adjusted rates of post-TAVR stroke, vascular complication, and blood transfusion were higher in females. Moreover, females demonstrated longer hospitalizations, higher costs and reduced rates of independent discharge home.
Conclusion
Sex-based differences in TAVR in-hospital outcomes persist in contemporary practice with third generation transcatheter heart valves. Further research is needed to assess the reasons for these observed disparities and to identify effective mitigation strategies.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:176-183

Racial disparities in the treatment of aortic stenosis: Has transcatheter aortic valve replacement bridged the gap?

Erinne I, Sethi A, Johannesen J, Kassotis J
Background
Racial disparities in outcomes and utilization of surgical aortic valve replacement (SAVR) for the treatment of severe aortic stenosis (AS) is well known. While transcatheter aortic valve replacement (TAVR) has become more widespread, its impact on racial disparities remains unclear.
Objectives
Our goal was to assess the utilization of SAVR and TAVR and their clinical outcomes among various racial groups.
Methods
The National Inpatient database (2009-2015) was used to study the racial distribution of admissions for SAVR and TAVR, and their impact on inpatient outcomes. Survey estimation commands were used to determine weighted national estimates.
Results
There were 3,445,267; 294,108; and 52,913 inpatient visits for AS, SAVR, and TAVR, respectively. SAVR visits were 86% White, 3.8% Black, 5.5% Hispanic, 1.2% Asian/Pacific Islander (A/PI), 0.4% Native American (NA), and 2.9%; TAVR were 87.7% White, 3.7% Black, 3.8% Hispanic, 1.0% A/PI, 0.2% NA, and 3.5% Other while AS visits were 83.7% White, 6.7% Black, 5.3% Hispanic, 1.7% A/PI, 0.4% NA, and 2.2% Other. Racial minorities generally had more co-morbidities compared with Whites. After SAVR, Black patients had a higher unadjusted inpatient mortality than Whites, however, there was no difference after adjustment for other variables. A/PI were more likely to require a permanent pacemaker after SAVR. Need for blood transfusion was significantly higher among the minorities compared with Whites, except for NA, but there were no racial differences in stroke rates. There was no difference in inpatient mortality, pacemaker implantation, stroke, and bleeding after TAVR, but acute kidney injury occurred more often in Hispanics, A/PI, and \"others\" compared with Whites.
Conclusions
Racial disparities in the treatment of AS continues in the contemporary era; however it was found that TAVR resulted in comparable inpatient outcomes, despite higher comorbidities, and adverse socioeconomic factors in minorities.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:148-156

Optimizing mechanical circulatory support hemodynamics using coronary sinus pacing.

Tahir H, Tonks R, Cox J, Baljepally R
The role of atrioventricular (AV) dyssynchrony as a cause of low Impella device output in cardiogenic shock from acute anterior myocardial infarction (MI) responding to reestablishing AV synchrony has not been previously reported. We present, for the first time, a unique case of AV dyssynchrony causing recurrent hypotension and ventricular fibrillation in such a patient, followed by immediate return to hemodynamic stability after restoring AV synchrony. Our case also highlights the novel use of a Damato multi-polar catheter for coronary sinus pacing to achieve AV synchrony.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:E78-E84

A new combined antegrade and retrograde approach for chronic total occlusion recanalization: Facilitated antegrade fenestration and re-entry.

Azzalini L, Carlino M
While antegrade techniques remain the cornerstone of chronic total occlusion (CTO) percutaneous coronary intervention (PCI), operators have often to resort to the retrograde approach in complex occlusions. In particular, lesions with proximal cap ambiguity, unclear vessel course and/or poor distal landing zone are difficult to tackle with either antegrade wiring or antegrade dissection and re-entry (ADR), and often require the retrograde approach. After collateral channel crossing, the retrograde approach usually culminates with either reverse controlled antegrade and retrograde subintimal tracking (CART) or retrograde true lumen crossing. Both techniques usually involve the use of an externalization wire, which requires keeping a higher activate clotting time to prevent thrombosis of the retrograde channel and is potentially associated with risk for donor vessel injury. In 2018, we described antegrade fenestration and re-entry (AFR), a targeted ADR technique in which fenestrations between the false and true lumen are created by antegrade balloon dilatation in the extraplaque space at the level of the distal cap, which are subsequently engaged by a polymer-jacketed wire to achieve re-entry. We hypothesized that AFR can also expedite antegrade crossing of the CTO after a wire has reached the distal vessel in a retrograde fashion. In this report, we present two cases in which we successfully achieved antegrade CTO crossing with AFR following retrograde advancement of a guidewire to the distal cap, in new variant of the technique, which we called \"facilitated AFR\".

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:E85-E90

Vascular complications associated with intraaortic balloon pump supported percutaneous coronary intervention (PCI) and clinical outcomes from the British Cardiovascular Intervention Society National PCI Database.

Kinnaird T, Anderson R, Gallagher S, Sharp ASP, ... Nolan J, Mamas M
Introduction
The impact of a vascular complication (VC) in the setting of intraaortic balloon pump (IABP) supported PCI on clinical outcomes is unclear.
Methods
Using data from the BCIS National PCI Database, multivariate logistic regression was used to identify independent predictors of a VC. Propensity scoring was used to quantify the association between a VC and outcomes.
Results
Between 2007 and 2014, 9,970 PCIs in England and Wales were supported by IABP (1.6% of total PCI), with 224 femoral VCs (2.3%). Annualized rates of a VC reduced as the use of radial access for PCI increased. The independent predictors of a VC included a procedural complication (odds ratio [OR] 2.9, p < .001), female sex (OR 2.3, p < .001), PCI for stable angina (OR 3.47, p = .028), and use of a glycoprotein inhibitor (OR 1.46 [1.1:2.5], p = .04), with a lower likelihood of a VC when radial access was used for PCI (OR 0.48, p = .008). A VC was associated with a higher likelihood of transfusion (OR 5.7 [3.5:9.2], p < .0001), acute kidney injury (OR 2.6 [1.2:6.1], p = .027), and periprocedural MI (OR 3.2 [1.5:6.7], p = .002) but not with adjusted mortality at discharge (OR 1.2 [0.8:1.7], p = .394) or 12-months (OR 1.1 [0.76:1.56], p = .639). In sensitivity analyses, there was a trend towards higher mortality in patients experiencing a VC who underwent PCI for stable angina (OR 4.1 [1.0:16.4], p value for interaction .069). Discussion and
Conclusions:
Although in-hospital morbidity was observed to be adversely affected by occurrence of a VC during IABP-supported PCI, in-hospital and 1-year survival were similar between groups.

© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:E53-E61

National trends of utilization and readmission rates with intravascular ultrasound use for ST-elevation myocardial infarction.

Ya\'qoub L, Gad M, Saad AM, Elgendy IY, Mahmoud AN
Background
Randomized trials have confirmed that intravascular ultrasound (IVUS) guidance for percutaneous coronary interventions (PCI) improves long-term clinical outcomes. However, data on real-world utilization of IVUS in ST-elevation myocardial infarction (STEMI) and the impact on short to mid-term outcomes are scarce. We sought to evaluate the utilization and the readmission rates for IVUS-guided PCI in the setting of STEMI.
Methods
Hospitalizations with a primary diagnosis of STEMI undergoing PCI were included from the Nationwide Readmissions Database (NRD) during 2012-2017.
Results
Among 809,601 hospitalizations with STEMI undergoing PCI, 33,644 (4.2%) underwent IVUS-guided PCI. IVUS use increased from 4.2% in 2012 to 5.6% in 2017 (p < .0001). After matching, in-hospital mortality was significantly lower with IVUS use (3.9% vs. 4.6%, p < .0001). The overall readmission rates were similar in both groups. We found that readmission rates due to acute MI at 6 months (5.7% vs. 6%, p = .045) and 11 months (5.1% vs. 6.5%, p = .005) as well as the PCI and mortality rates during readmission at 11 months (2.1% vs. 3%, p = .008, and 0.7% vs. 1.4%, p = .002, respectively) were significantly lower in the IVUS group.
Conclusions
The utilization of IVUS in STEMI appears to be slowly increasing. Although overall readmission rates were similar, IVUS was associated with lower in-hospital mortality, lower rates of readmission due to acute MI at 6 and 11 months, as well as lower PCI and mortality at 11 months. Randomized trials evaluating long-term benefits of IVUS in STEMI are needed.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:1-9

The incidence, natural history, and predictive factors for tissue protrusion after drug-eluting stent implantation.

Otagaki M, Fujii K, Matsumura K, Noda T, ... Yoshioka K, Shiojima I
Objectives and background
Although tissue protrusion (TP) between the stent struts after stent implantation has been implicate as a potential factor of stent failure, the incidence, natural history, and predictive factor of TP after stent implantation remains unclear. This prospective study evaluated the fate of TP after drug-eluting stent (DES) deployment using optical coherence tomography (OCT).
Method and result
This study analyzed TP for 42 lesions after DES in which three serial OCTs, including preprocedure, postprocedure, and 1-month after the procedure were performed. TP was classified into the five groups: (a) persistent, (b) progressive, (c) healed, (d) regressive, and (e) late-acquired. Immediately after the procedure, 100 TPs in 37 lesions (88%) were identified. Of those, 53 (53%) were persistent, 3 (3%) were progressive, 20 (20%) were healed, and 24 (24%) were regressed at 1-month follow-up. Seven TPs in five patients (13%) were observed only at 1-month follow-up (late-acquired).
Conclusion
In lesions with late-acquired TP, calcified nodule was identified as an underlying plaque morphology on preprocedural OCT. A serial OCT analysis found TP occurred not only immediately after DES implantation, but also 1-month after DES implantation.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:E62-E68

Outcomes of transcatheter aortic valve replacement in end stage liver and renal disease.

Caughron H, Parikh D, Allison Z, Deuse T, Mahadevan VS
Objectives
This study evaluates in-hospital, 30-day, and 1-year outcomes post-transcatheter aortic valve replacement (TAVR) in end stage liver disease (ESLD) and/or end stage renal disease (ESRD) compared with patients without these comorbidities.
Background
TAVR is an alternative to surgical aortic valve replacement in patients with ESLD and ESRD, though current outcomes data are limited.
Methods
We compared 309 patients (N = 29 ESLD and/or ESRD, N = 280 control) age > 18 who underwent transfemoral TAVR from 2014 to 2020 have been compared.
Results
Patients with ESLD and ESRD were younger (69.9 ± 11.7 vs. 79.1 ± 9.8, p < .01) with higher STS-PROM scores (8.1 ± 6.7 vs. 4.6 ± 3.9, p < .01). ESRD and ESLD patients had similar rates of in-hospital major vascular complications (3.4% vs. 3.2%, p = .96), major bleeding events (3.4% vs. 3.2%, p = .95), and mortality (0.0% vs. 1.8%, p = .47). Mortality rates were similar at 30-days (3.4% vs. 2.1%, p = .65) with trend to higher mortality at 6-months (6.9% vs. 3.2%, p = .31) and 1-year (15.4% vs. 7.0%, p = .13). Readmission rates were higher in the ESLD and ESRD cohort at 6-months (53.2% vs. 28.6%, p < .01) and 1-year (65.4% vs. 41.0%, p = .02). One patient received dual kidney-liver transplant, 1 patient received a liver transplant, and 7 additional patients were listed for transplant.
Conclusion
Patients with ESLD and/or ESRD who underwent TAVR had similar mortality at discharge and 30-days compared with patients without these comorbidities with a trend toward increased mortality at 1-year. This study suggests that TAVR is an option for aortic valve disease patients with ESRD and/or ESLD in order to remove cardiac barriers to liver or kidney transplant.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:159-167

Long-term clinical, angiographic, and optical coherence tomography findings of Mg-based bioresorbable scaffold in patients with acute coronary syndrome.

Gutiérrez-Barrios A, Gheorghe LL, Camacho Freire S, Silva E, ... Bretones Del Pino T, Calle Perez G
Background
This study sought to evaluate the clinical outcomes of patients treated with magnesium-based bioresorbable scaffolds (MgBRS) in the context of acute coronary syndromes (ACS) at long-term follow-up (24 months). The study also aims to investigate the MgBRS performance by angiography and the healing and bioresorption pattern by optical coherence tomography (OCT) at 18 months.
Methods
Between December 2016 and December 2018, a total of 90 patients admitted for ACS and treated with MgBRS (Magmaris, Biotronik AG, Bülach, Switzerland) were enrolled in a multicenter prospective study. Clinical follow-up was performed in all patients at 24 months and angiographic and OCT follow-up in 51.5% of patients at 18 months. Serial OCT was available in 33 patients (36.7%).
Results
At a 2-year follow-up, 88.8% were free of symptoms, no cardiac death was reported, and the device-oriented composite event (DOCE): consisting of cardiac death, target vessel myocardial infarction, and target lesion revascularization (TLR) was 13.3%. Stent thrombosis and TLR were observed in 2.2 and 11.1%, respectively. Binary restenosis was observed in 21.7% of cases and in-stent late lumen loss was 0.61 ± 0.75 mm. By serial OCT imaging, the minimal lumen area was significantly reduced greater than 40% (from 6.12 ± 1.59 to 3.5 ± 1.55 mm2, p < .001). At follow-up, area stenosis was 44.33 ± 23.07% and half of the patients presented indiscernible struts. The principal observed mechanism of restenosis was scaffold collapse.
Conclusions
At long-term follow-up, MgBRS implantation in ACS patients showed a high rate of DOCE, mainly caused by clinically driven TLR. MgBRS restenosis was caused by scaffold collapse in most of the cases.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:E69-E77

Elective versus urgent in-hospital transcatheter aortic valve implantation.

Kabahizi A, Sheikh AS, Williams T, Tanseco K, ... Cockburn J, Hildick-Smith D
Background
Transcatheter aortic valve implantation (TAVI) is maturing as a treatment option and is now often undertaken during an unscheduled index hospital admission. The aim of this study was to look at procedural and mid-term outcomes of patients undergoing elective versus urgent in-hospital transcatheter aortic valve implantation.
Methods
We identified a total of 1,157 patients who underwent TAVI between November 2007 and November 2019 at the Sussex Cardiac Centre in the UK. We compared the demographics, procedural outcomes, 30-day and 1-year mortality between elective and urgent patients. Emergency and salvage TAVI cases were excluded.
Results
Of the 1,157 patients who underwent the procedure, 975 (84.3%) had elective while 182 (15.7%) had urgent TAVI. Predominant aortic stenosis was more frequent in elective patients (91.7% vs. 77.4%); p < .01), while predominant aortic regurgitation was seen more commonly in the urgent group (11.5% vs. 4.2%; p < .01). Implantation success was similar between the elective (99.1%) and urgent group (99.4%). In-hospital (1.65% vs. 1.3%: p .11), 30 day (3.5% vs. 3.3%: p .81) and 1 year (10.9% vs. 11%; p .81) mortality rates were similar in the elective and urgent groups, respectively.
Conclusions
In contemporary practice, urgent TAVI undertaken on the index admission can be performed at similar risk to elective outpatient TAVI.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:170-175

Edge to edge repair using a MitraClip for severe tricuspid valve regurgitation after a Mustard operation.

Iriart X, Guérin P, Jalal Z, Thambo JB
A 48-year-old who underwent a Mustard operation in 1972 followed by a second cardiac intervention in 1996 for pulmonary venous baffle enlargement and residual baffle leak closure, complicated by recurrent atrial flutter, was admitted to our institution for severe systemic atrio-ventricular valve regurgitation (SAVVR) associated with severely impaired systemic right ventricular (RV) function. After careful preoperative anatomic assessment including three-dimensional transesophageal echocardiography (3DTEE) to define the clipping strategy and computed tomography to optimize the transvenous baffle puncture site, the intervention was performed under general anesthesia, fluoroscopic, and 3DTEE guidance. One XTR MitraClip was successfully implanted, achieving a significant reduction in regurgitation and immediate clinical improvement. The transbaffle puncture was closed using an 8 mm atrial septal defect (ASD) device without residual shunt or obstruction of the venous baffle. Post-operative clinical evaluation showed immediate improvement in the NYHA functional class (from III to II), but the patient presented with recurrent flutter at 1 week after the procedure, which was successfully treated by catheter ablation with another transbaffle approach next to the ASD device. Clinical improvement was maintained at 1- and 6-month follow-up with significant reduction in SAVVR, reduced systemic RV volumes and improved RV ejection fraction. This case demonstrates the feasibility of percutaneous treatment of systemic SAVV in patients with systemic RV after atrial redirection.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:E108-E114

Use of edge-to-edge percutaneous mitral valve repair for severe mitral regurgitation in cardiogenic shock: A multicenter observational experience (MITRA-SHOCK study).

Falasconi G, Melillo F, Pannone L, Adamo M, ... Montorfano M, Agricola E
Objectives
The aim of this study was to evaluate the impact of edge-to-edge PMVR on short and mid-term clinical outcomes in patients with CS and severe MR.
Background
Severe mitral regurgitation (MR) in the setting of cardiogenic shock (CS) is associated with three times higher risk of 1-year mortality. In refractory CS, edge-to-edge percutaneous mitral valve repair (PMVR) can be a potential therapeutic option.
Methods
We retrospectively included consecutive patients with refractory CS and concomitant severe MR treated with MitraClip® system. CS was defined according to the criteria used in the SHOCK trial and procedural success according to Mitral Valve Academic Research Consortium (MVARC) criteria. The 30-day and 6-month mortality were the primary and secondary endpoints respectively.
Results
Thirty-one patients (median age 73 years [interquartile range, IQR 66-78], 25.8% female), STS mortality score 37.9 [IQR 30.4-42.4]), with CS and concomitant severe MR treated with edge-to-edge PMVR were retrospectively enrolled. Procedural success was 87.1%. Thirty-day and 6-month survival rates were 78.4 and 45.2% respectively. Univariate Cox Regression Model analysis showed that procedural success was a predictor of both 30-day (HR = 0.12, 95% CI 0.03-0.55, p < .01) and 6-month survival (HR = 0.22, 95% CI 0.06-0.84, p = .027).
Conclusions
Edge-to-edge PMVR in patients with CS and concomitant severe MR was associated with good procedural safety and success with acceptable short and mid-term survival rates. It could be considered a bailout option in this setting of patients.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:E163-E170

Percutaneous deep venous arterialization at femoropopliteal segment for unhealed amputated stump ulcer after below the knee amputation.

Ichihashi S, Tamura Y, Maeda S, Kichikawa K
Efficacy of percutaneous deep venous arterialization (pDVA) has been reported for patients with no-option chronic limb threatening ischemia. To date, the procedure has been limited for below the knee/below the ankle occlusive disease. The present report describes the pDVA performed at a femoropopliteal segment for a patient with a stump complication after below the knee amputation. The patient was a 70-year-old male who had a history of endovascular treatment in the right superficial femoral artery (SFA) and below knee amputation 6 years before. He had an unhealed ulcer at the amputated stump for 3 years. Computed tomography angiography demonstrated occluded right SFA, with a stenotic popliteal artery. Revascularization was considered unfeasible due to the absence of run off vessels. In order to improve the perfusion at the ulcer, pDVA was performed at the distal SFA level, bridging SFA and femoral vein using stent grafts. The final angiogram demonstrated the revascularized SFA connecting to popliteal vein with a brisk flow. After pDVA, the stump ulcer improved and the stent grafts were kept patent after 6 months of the procedure. pDVA at the SFA level was technically feasible and could be a useful approach for stump complication after below knee amputation.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:E124-E126

Can a self-expanding pediatric stent expand with an artery? Relationship of stent design to vascular biology.

Nia NV, Fishbein GA, Levi DS
Objectives
A large-diameter, intravascular, self-expanding stent system capable of continued expansion during somatic and vascular growth was modeled with finite element analysis (FEA), manufactured and tested in an animal model.
Background
Children can quickly outgrow intravascular stents. If a stent could expand after implantation in arteries this would be ideal for use in pediatric patients.
Methods
Computer-aided design and FEA were used to design and manufacture large-diameter, self-expanding nitinol stents with both high and low chronic outward force (COF). Four distinct stents with similar designs but with variable lengths and strut thicknesses were manufactured. Fourteen of these stents were implanted in the abdominal aortas or iliac arteries of four juvenile swine.
Results
All animals survived without complication to their designated time points of harvest (90 or 180-days), and all stents expanded to greater diameters than the adjacent non-stented artery. Luminal diameter growth was 34-49% and 20-23% for stented and non-stented segments, respectively. Histologic examination revealed variable degrees of the internal elastic lamina and/or medial disruption with a mean injury score ranging from 0.70 ± 0.56 to 1.23 ± 0.21 and low COF stents implanted in smaller arteries having a larger injury score. Inflammatory responses and stenosis formation were minimal and ranged from 0.50 ± 0.71 to 3.00 ± 0.00 and 5.52 ± 1.05% to 14.68 ± 9.12%, respectively. The stent\'s COF did not correlate with vessel expansion or vascular injury.
Conclusions
Self-expanding stents can mirror and even exceed somatic growth. Although longer-term testing is needed, it may be possible to custom tailor self-expanding stents to expand after arterial implantation in pediatric patients.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:139-147

Management of dead space thrombosis during decannulation of peripherally inserted venoarterial extracorporeal membrane oxygenation.

Sulimov DS, Markuske M, Desch S, Thiele H
Ischemic complications after percutaneous decannulation of veno-arterial extracorporeal membrane oxygenation (va-ECMO) are not rare and can lead to significant morbidity or even mortality in case of delayed diagnosis or treatment. A possible cause of thromboembolic complications is the formation of thrombus between in the short segment between the large bore retrograde arterial cannula of va-ECMO and the antegrade limb perfusion sheath due to absence of blood flow (dead space). In this case report, we demonstrate a new technique of flushing the dead space to prevent embolic complications during va-ECMO decannulation.

© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:E122-E123

CARotid plaqUe StabilizatiOn and regression with evolocumab: Rationale and design of the CARUSO study.

Aranzulla TC, Piazza S, Ricotti A, Musumeci G, Gaggiano A
Background
While the experience with PCSK9i in patients with coronary artery disease has been wide, and coronary plaque regression has been documented, little is known regarding the role of these drugs on carotid plaque regression. The CARotid plaqUe StabilizatiOn and regression with evolocumab (CARUSO) study is a randomized, single-center, investigator-initiated trial aiming at evaluating carotid plaque morphological stabilization and regression following, respectively, 6 and 12 months of therapy with evolocumab.
Methods
Asymptomatic patients with uni- or bilateral de novo carotid artery stenosis ≥50% and LDL-C values ≥100 mg/dl despite maximum tolerated lipid lowering therapy (LLT) will be randomized to evolocumab 140 mg s.c. every 2 weeks on top of ongoing LLT, or no additional treatment. 100 patients (50 in each arm) will be enrolled. Serial carotid duplex ultra-sonography will be performed to monitor the carotid plaque morphology and stenosis over time.
Results
The primary end point of the study is, (a) carotid plaque morphological stabilization at 6 months, defined as defined as the disappearance of ulcerations and fluffy components and the achievement of a regular plaque morphology with prevalence of fibrous atheroma and/or (b) carotid plaque regression at 12 months, defined as reduction of the entity of the stenosis and/or peak systolic velocity by at least 5%, as compared with baseline.
Conclusion
The CARUSO trial will test the superiority of evolocumab on top of ongoing LLT versus ongoing LLT alone regarding carotid plaque morphological stabilization and regression. The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:E115-E121

Correction of sinus venosus atrial septal defects with the 10 zig covered Cheatham-platinum stent - An international registry.

Rosenthal E, Qureshi SA, Jones M, Butera G, ... Vettukattil JJ, Zahn EM
Background
Covered stent correction of sinus venosus ASDs (SVASD) is a relatively new technique. Challenges include anchoring a sufficiently long stent in a nonstenotic superior vena cava (SVC) and expanding the stent at the wider SVC-RA junction without obstructing the anomalous right upper pulmonary vein (RUPV). The 10-zig covered Cheatham-platinum (CCP) stent has the advantage of being available in lengths of 5-11 cm and dilatable to 34 mm in diameter.
Methods
An international registry reviewed the outcomes of 10-zig CCP stents in 75 patients aged 11.4-75.9 years (median 45.4) from March 2016. Additional stents were used to anchor the stent in the SVC or close residual shunts in 33/75. An additional stent was placed in 4/5 (80%) with 5/5.5 cm CCPs, 18/29 (62%) with 6 cm CCPs, 5/18 (28%) with 7 cm CCPs, 5/22 (23%) with 7.5/8 cm CCPs and 0/1 with an 11 cm CCP. A \"protective\" balloon catheter was inflated in the RUPV in 17.
Results
Early stent embolization in two patients required surgical removal and defect repair and tamponade was drained in one patient. The CT at 3 months showed occlusion of the RUPV in one patient. Follow up is from 2 months to 5.1 years (median 1.8 years). QP:QS has reduced from 2.5 ± 0.5 to 1.2 ± 0.36 (p < .001) and RVEDVi from 149.1 ± 35.4 to 95.6 ± 21.43 ml/m2 (p < .001).
Conclusions
Ten-zig CCPs of 7-8 cm appear to provide reliable SVASD closure with a low requirement for additional stents. Careful selection of patients and meticulous attention to detail is required to avoid complications.

© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Jun 2021; 98:128-136

Bilateral branch pulmonary artery Pulsta valve implantation for treatment of large right ventricular outflow tract in a high-risk patient.

Kim JY, Kim SH, Jang SI
Percutaneous pulmonary valve implantation (PPVI) has been implemented as a novel alternative strategy to surgical pulmonary valve replacement. However, PPVI has an inevitable limitation: the large right ventricular outflow tract (RVOT) lesions exhibit variable geometry and significant pulmonary regurgitation (PR). To overcome this limitation, bilateral branch pulmonary artery (PA) valve implantations using Melody or Sapien valves have been attempted and have shown a reduction in right ventricular volume with clinical benefits in the intermediate term. Nevertheless, these trials also have constraints of large branch PA size. Recently, a feasibility study using the Pulsta valve (Tae Woong Medical Co, Gyeonggi-do, South Korea) for native RVOTs was reported; the diameter of the Pulsta valve ranges from 18 to 32 mm. Herein, we present a successful percutaneous bilateral branch PA valve implantation using two 32 mm Pulsta valves in a 59-year-old man who showed right heart failure with severe pulmonary regurgitation despite several open heart surgeries for tetralogy of Fallot. The main PA was measured to be 49 mm, and both the right and left PAs were measured to be 30 mm.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 06 Jul 2021; epub ahead of print

Clinical predictors and impact of postoperative mean gradient on outcome after transcatheter edge-to-edge mitral valve repair.

Oguz D, Padang R, Pislaru SV, Nkomo VT, ... Rihal CS, Thaden JJ
Background
The predictors and clinical significance of increased Doppler-derived mean diastolic gradient (MG) following transcatheter edge-to-edge mitral valve repair (MVTEER) remain controversial.
Objective
We sought to examine baseline correlates of Doppler-derived increased MG post-MVTEER and its impact on intermediate-term outcomes.
Methods
Patients undergoing MVTEER were analyzed retrospectively. Post-MVTEER increased MG was defined as >5 mmHg or aborted clip implantation due to increased MG intraprocedurally. Baseline MG and 3D-guided mitral valve area (MVA) by planimetry were retrospectively available in 233 and 109 patients.
Results
243 patients were included; 62 (26%) had MG > 5 mmHg post-MVTEER or aborted clip insertion, including 7 (11%) that had aborted clip implantation. Mortality occurred in 63 (26%) during a median follow up of 516 days (IQR 211, 1021). Increased post-MVTEER MG occurred more frequently in females (44% vs. 16%, p <  0.001), those with baseline MVA <4.0 cm² (71% vs. 16%), baseline MG ≥4 mmHg (61% vs. 20%), or multiple clips implanted (33% vs. 21%, p = 0.04). Increased post-MVTEER MG was associated with increased subsequent mortality compared to those with normal gradient (HR 1.91 95% CI 1.15-3.18 p = 0.016) as was aborted clip insertion compared to all others (HR 5.23 95% CI 2.06-13.28 p <  0.001).
Conclusions
Smaller baseline MVA and increased baseline MG are associated with increased MG post-MVTEER and patients with a Doppler-derived post-MVTEER MG >5 mmHg suffered excess subsequent mortality. In high risk patients considered for MVTEER, identification of those at risk of iatrogenic mitral stenosis with MVTEER is important as they may be optimally treated with alternate surgical or transcatheter therapies.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 09 Jul 2021; epub ahead of print

Polymer-free Biolimus-A9 coated thin strut stents for patients at high bleeding risk 1-year results from the LEADERS FREE III study.

Eberli FR, Stoll HP, Urban P, Morice MC, ... Slama SS, Garot P
Background
In patients at high bleeding risk (HBR), the LEADERS FREE (LF) trial established the safety and efficacy of a polymer-free drug coated (Biolimus-A9) stainless steel stent (SS-DCS) with 30 days of dual antiplatelet treatment (DAPT). In LEADERS FREE III, we studied a new cobalt-chromium thin-strut stent (CoCr-DCS) in HBR patients.
Methods
The CoCr-DCS shares all of the design features of the SS-DCS but has a CoCr stent platform with strut thickness of 84-88 μm. The primary safety endpoint was a composite of cardiac death, myocardial infarction (MI), and definite/probable stent thrombosis. The primary efficacy endpoint was clinically indicated target lesion revascularization. Outcomes were compared to those of LF (non-inferiority to SS-DCS for safety and superiority to SS-BMS for efficacy). Additional propensity-matched comparisons were performed to account for baseline differences.
Results
We recruited 401 HBR patients using identical criteria to the LF trial. At 1 year, the primary safety endpoint was reached by 31/401 (8.0%) of patients treated with the CoCr-DCS versus 35/401 (8.9%) for the propensity-matched cohort (HR: 0.89, [0.55-1.44], p < 0.001 for non-inferiority, 0.62 for superiority). The efficacy endpoint was reached by 16/401 (4.2%) of CoCr-DCS patients versus 41/401 (10.6%) in the propensity-matched cohort (HR: 0.4 [0.2:0.7]) (p = 0.007 for superiority). There was no statistical difference between CoCr-DCS and SS-DCS in terms of efficacy (HR: 1.46 [0.68-3.15], p = 0.33).
Conclusions
The new thin-strut CoCr-DCS proved non-inferior to the SS-DCS for safety, and superior to the BMS for efficacy in HBR patients treated with 30 days of DAPT.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 08 Jul 2021; epub ahead of print

Coronary microcirculation assessment using functional angiography: Development of a wire-free method applicable to conventional coronary angiograms.

Mejia-Renteria H, Lee JM, Choi KH, Lee SH, ... Koo BK, Escaned J
Objectives
We aimed to develop a novel wire- and adenosine-free microcirculatory resistive index from functional angiography (angio-IMR) to estimate coronary microcirculatory resistance, and to investigate how this method can improve clinical interpretation of physiological stenosis assessment with quantitative flow ratio (QFR).
Background
Hyperemic index of coronary microcirculatory resistance (IMR) is a widely used tool to assess microcirculatory dysfunction. However, the need of dedicated intracoronary wire and hyperemia limits its adoption in clinical practice.
Methods
We performed our study in two separate stages: (1) development of a formula (angio-IMR) to estimate IMR from resting angiograms and aortic pressure (Pa), and (2) validation of the method in a clinical population using invasively measured IMR as reference. Additionally, QFR diagnostic performance was assessed considering angio-IMR values.
Results
We developed the formula: angio-IMR = (Pa-[0.1*Pa])*QFR*e-Tmn (where e-Tmn is an estimation of hyperaemic mean transit time) and validated it in 115 vessels (104 patients). Angio-IMR correlated well with IMR (Spearman\'s rho = 0.70, p < 0.001). Sensitivity, specificity, positive and negative predictive value, accuracy and area under the curve of angio-IMR to predict IMR were 87.5% (73.2-95.8), 85.3% (75.3-92.4), 76.1% (64.5-84.8), 92.8% (84.9-96.7), 85% and 0.90 (0.83-0.95), respectively. False positive QFR measurements decreased from 19.5% to 8.5% when angio-IMR was incorporated into the QFR interpretation workflow.
Conclusions
Estimation of IMR without physiology wire and adenosine is feasible. Coronary microcirculatory dysfunction causing high IMR can be ruled-out with high confidence in vessels with low angio-IMR. Awareness of angio-IMR contributes to a better clinical interpretation of functional stenosis assessment with QFR.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 08 Jul 2021; epub ahead of print

Long term outcomes of ultrathin versus standard thickness second-generation drug eluting stents: Meta-analysis of randomized trials.

Hussain Y, Gaston S, Kluger J, Shah T, ... Tirziu D, Lansky A
Objective
Identify the effect of ultrathin drug eluting stents on long term outcomes in coronary artery disease.
Background
Although second-generation drug eluting stents (DES) are superior to first-generation DES, persistence of adverse outcomes has led to continued refinement in design. Ultrathin second-generation DES have been shown to improve outcomes at 1-year follow-up. Beyond 1-year their effect remains unknown.
Methods
PubMed, Embase and Cochrane Database were searched for randomized controlled trials that compared ultrathin (defined as <70 um) to standard thickness second-generation DES. Studies were chosen according to the PROSPERO protocol (CRD42020185374). Data from randomized controlled trials were pooled using random-effects model (Mantel-Haenszel). The primary outcome was target lesion failure (TLF) at 2 years, a composite of cardiac death, target vessel myocardial infarction, and ischemia-driven target vessel revascularization. Secondary outcomes included TLF at 3 and 5 years, the components of TLF and definite or probable stent thrombosis. Differences in outcomes between groups were presented in Forest plots as risk ratios (RR) with corresponding 95% confidence intervals (CIs) for each trial.
Results
We identified 18 publications from 10 trials with14,649 patients. At 2-years there was a significant 12% reduction in TLF (RR, 0.88; 95% CI 0.78-0.99; p < 0.05) associated with the use of ultrathin DES. At 3-years, there was a significant 19% reduction in TLF with ultrathin DES (RR, 0.79; 95% CI 0.64-0.98; p < 0.05).
Conclusion
In patients undergoing percutaneous coronary intervention, ultrathin DES improve long term clinical outcomes.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 07 Jul 2021; epub ahead of print

Coronary artery disease burden relation with the presentation of acute cardiac events and ventricular fibrillation.

Kosmopoulos M, Bartos JA, Raveendran G, Goslar T, ... Walser E, Yannopoulos D
Objectives
Evaluate the differences in coronary artery disease (CAD) burden between patients with ischemic resuscitated, ischemic refractory VT/VF OHCA events and N/STEMI.
Background
Refractory out-of-hospital cardiac arrest patients presenting with initial shockable rhythms (VT/VF OHCA) have the highest mortality among patients with acute cardiac events. No predictors of VT/VF OHCA refractoriness have been identified.
Methods
A retrospective cohort design was used to assess baseline characteristics, clinical outcomes, and the angiographic severity of disease among patients with VT/VF OHCA undergoing emergent coronary angiography at the University of Minnesota Medical Center. The Gensini score was calculated for all patients to assess the angiographic burden of CAD. For patients with ischemia-related cardiac arrest, outcomes were further compared to an independent non-OHCA population presenting with N/STEMI.
Results
During the study period, 538 patients were admitted after VT/VF OHCA. Among them, 305 presented with resuscitated, and 233 with refractory VT/VF. 66% of resuscitated and 70% of refractory VT/VF had an underlying, angiographically documented, ischemic etiology. Ischemic resuscitated and refractory VT/VF had significant differences in Gensini score, (80.7 ± 3.6 and 127.6 ± 7.1, respectively, p < 0.001) and survival (77.3% and 30.0%, respectively, p < 0.001). Both groups had a higher CAD burden and worse survival than the non-OHCA N/STEMI population (360 patients). Ischemic refractory VT/VF was significantly more likely to present with chronic total occlusion in comparison to both N/STEMI and ischemic resuscitated VT/VF.
Conclusion
Ischemia-related, refractory VT/VF OHCA has a higher burden of CAD and the presence of CTOs compared to resuscitated VT/VF OHCA and N/STEMI.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 07 Jul 2021; epub ahead of print

Incidence, treatment, and outcomes of acute myocardial infarction following transcatheter or surgical aortic valve replacement.

Isogai T, Saad AM, Ahuja KR, Shekhar S, ... Ellis SG, Kapadia SR
Objectives
This study aimed to evaluate the incidence, treatment, and outcomes of acute myocardial infarction (AMI) following transcatheter or surgical aortic valve replacement (TAVR or SAVR).
Background
Coronary artery disease is common in patients who undergo aortic valve replacement. However, little is known about differences in clinical features of post-TAVR or post-SAVR AMI.
Methods
We retrospectively identified post-TAVR or post-SAVR (including isolated and complex SAVR) patients admitted with AMI using the Nationwide Readmissions Database 2012-2017. Incidence, invasive strategy (coronary angiography or revascularization), and in-hospital outcomes were compared between post-TAVR and post-SAVR AMIs.
Results
The incidence of 180-day AMI was higher post-TAVR than post-SAVR (1.59% vs. 0.72%; p < 0.001). Post-TAVR AMI patients (n = 1315), compared with post-SAVR AMI patients (n = 1344), were older, had more comorbidities and more frequent non-ST-elevation AMI (NSTEMI: 86.6% vs. 78.0%; p < 0.001). After propensity-score matching, there was no significant difference in in-hospital mortality between post-TAVR and post-SAVR AMIs (14.7% vs. 16.1%; p = 0.531), but the mortality was high in both groups, particularly in ST-elevation AMI (STEMI: 38.8% vs. 29.2%; p = 0.153). Invasive strategy was used less frequently for post-TAVR AMI than post-SAVR AMI (25.6% vs. 38.3%; p < 0.001). Invasive strategy was associated with lower mortality in both post-TAVR (adjusted odds ratio = 0.40; 95% confidence interval = [0.24-0.66]) and post-SAVR groups (0.60 [0.41-0.88]).
Conclusions
AMI, albeit uncommon, was more frequent post-TAVR than post-SAVR. Patients commonly presented with NSTEMI, but the mortality of STEMI was markedly high. Further studies are needed to understand why a substantial percentage of patients do not receive invasive coronary treatment, particularly after TAVR, despite seemingly better outcomes with invasive strategy.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 07 Jul 2021; epub ahead of print

Efficacy and safety of glycoprotein IIb/IIIa inhibitors in addition to P2Y inhibitors in ST-segment elevation myocardial infarction: A subanalysis of the POPular Genetics trial.

Tavenier AH, Claassens DMF, Hermanides RS, Vos GJA, ... van \'t Hof AWJ, Ten Berg JM
Background
Glycoprotein IIb/IIIa inhibitors (GPI) are still used in patients with ST-segment elevation myocardial infarction (STEMI) who undergo primary percutaneous coronary intervention (PCI), although discussion about its clinical benefit is ongoing.
Methods
GPI use was analyzed in this subanalysis of the POPular Genetics trial, which randomized STEMI patients to CYP2C19 genotype-guided treatment (clopidogrel or ticagrelor) or standard treatment with ticagrelor/prasugrel. The composite thrombotic endpoint consisted of cardiovascular death, myocardial infarction (MI), definite stent thrombosis, and stroke at 30 days. The combined bleeding endpoint consisted of Platelet Inhibition and Patient Outcomes (PLATO) major and minor bleeding at 30 days. Univariable and multivariable analyses in addition to a propensity score-matched (PSM) analysis were conducted.
Results
In total, 2378 patients, of whom 1033 received GPI and 1345 did not, were included. In multivariable analysis, GPI administration was associated with fewer thrombotic events (hazard ratio [HR] 0.22, 95% confidence interval [CI] 0.09-0.55) and MIs (HR 0.24, 95% CI 0.08-0.73). Furthermore, GPI administration was associated with an increase in bleedings (HR 2.02, 95% CI 1.27-3.19), driven by minor bleedings (HR 2.32, 95% CI 1.43-3.76), without a significant difference in major bleedings (HR 0.69, 95% CI 0.19-2.57). In the PSM analysis, no significant association was found.
Conclusion
In STEMI patients undergoing primary PCI, GPI administration was associated with a reduction in thrombotic events at a cost of an increase in (mostly minor) bleedings in multivariable analysis, while propensity score analysis did not show significant associations.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 06 Jul 2021; epub ahead of print

Influence of fractional flow reserve on grafts patency: Systematic review and patient-level meta-analysis.

G Toth G, Collet C, Langhoff Thuesen A, Mizukami T, ... Okkels Jensen L, Barbato E
Objective
To investigate the impact of invasive functional guidance for coronary artery bypass graft surgery (CABG) on graft failure.
Background
Data on the impact of fractional flow reserve (FFR) in guiding CABG are still limited.
Methods
Systematic review and individual patient data meta-analysis were performed. Primary objective was the risk of graft failure, stratified by FFR. Risk estimates are reported as odds ratios (ORs) derived from the aggregated data using random-effects models. Individual patient data were analyzed using mixed effect model to assess relationship between FFR and graft failure. This meta-analysis is registered in PROSPERO (CRD42020180444).
Results
Four prospective studies comprising 503 patients referred for CABG, with 1471 coronaries, assessed by FFR were included. Graft status was available for 1039 conduits at median of 12.0 [IQR 6.6; 12.0] months. Risk of graft failure was higher in vessels with preserved FFR (OR 5.74, 95% CI 1.71-19.29). Every 0.10 FFR units decrease in the coronaries was associated with 56% risk reduction of graft failure (OR 0.44, 95% CI 0.34 to 0.59). FFR cut-off to predict graft failure was 0.79.
Conclusion
Surgical grafting of coronaries with functionally nonsignificant stenoses was associated with higher risk of graft failure.

© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 06 Jul 2021; epub ahead of print

Mid-term outcomes of the Pulsta transcatheter pulmonary valve for the native right ventricular outflow tract.

Lee SY, Kim GB, Kim SH, Jang SI, ... Kang IS, Kim YH
Objectives
The aim of this study is to present the mid-term outcomes of Pulsta valve.
Background
The Pulsta valve is a Self-expandable knitted nitinol-wire stent mounted with a treated tri-leaflet α-Gal-free porcine pericardial valve for percutaneous pulmonary valve implantation (PPVI) in patients with native right ventricular outflow tract (RVOT) lesions.
Methods
A multi-center clinical trial using Pulsta valve® was designed for patients with severe pulmonary regurgitation (PR) in the native RVOT in multiple centers in South Korea and 25 patients were enrolled. Before PPVI, severe PR (mean PR fraction: 45.5 ± 6.9%) and enlarged RV volume (mean indexed RV end-diastolic volume; 169.7 ± 13.0 ml/m² ) was present. The mean age was 21.6 ± 6.6 years old.
Results
All patients were successfully implanted with 26, 28, or 32 mm diameter of Pulsta valve loaded on the 18 or 20 French delivery catheters. At 6 months follow up, indexed RV end-diastolic volume was decreased to 126.9 ± 16.9 ml/m² . At mean 33.1 ± 14.3 months follow-up, the mean value of mean pressure gradient in Pulsta valve was 6.5 ± 3.0 mmhg without significant PR. There was no serious device-related adverse event.
Conclusions
A multi-center clinical trial was completed successfully with planned Pulsta valve implantation and demonstrated good mid-term effectiveness without device-related serious adverse events.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 05 Jul 2021; epub ahead of print

Causes and predictors of mortality after transcatheter mitral valve implantation in patients with severe mitral annulus calcification.

Urena M, Lemann T, Chong-Nguyen C, Brochet E, ... Vahanian A, Himbert D
Objectives
To evaluate the causes and predictors of mortality after valve-in-mitral annulus calcification (MAC) transcatheter mitral valve implantation (TMVI).
Background
Conventional surgical mitral valve replacement is associated with a high risk in patients with mitral valve disease associated with severe MAC. In this population, TMVI may be an attractive alternative option. However, its prognostic factors are poorly understood.
Methods
All patients undergoing valve-in-MAC TMVI from 2013 to 2018 in our center were included. Indication for TMVI relied on the judgment of the local heart team. Patients were followed at 30 days and 1 year.
Results
A total of 34 patients underwent valve-in-MAC TMVI. The mean age was 79 ± 11 years and 73% of patients were women. Their mean EuroSCORE 2 was 8 ± 7%. The transseptal approach was used in 79% of patients and a hybrid transatrial in 29%. Balloon expandable transcatheter heart valves were used in all the patients. Technical success was achieved in 76% of the patients. Thirty-day and 1-year all-cause mortality rates were 14.7% and 32.4%, respectively. The main two causes of 1-year mortality were congestive heart failure (8.8%) and infective endocarditis (5.9%). In multivariate analysis, the only predictor of 1-year mortality was the presence of periprothetic mitral regurgitation grade 2 (HR, 5.69; 95%CI, 1.59-27.88, p = 0.032).
Conclusion
Early and mid-term mortality remains high after valve-in-MAC TMVI and seems to be associated with the presence of paravalvular mitral regurgitation. However, whether the latter is a prognostic factor or marker remains to be determined to improve clinical outcomes in this high-risk population.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Jul 2021; epub ahead of print