Diastolic Function and Clinical Outcomes After Transcatheter Aortic Valve Replacement: PARTNER 2 SAPIEN 3 Registry.

Ong G, Pibarot P, Redfors B, Weissman NJ, ... Douglas PS, Hahn RT
Background
Few studies have evaluated if diastolic function could predict outcomes in patients with aortic stenosis.
Objectives
The authors aimed to assess the association between diastolic dysfunction (DD) and outcomes in patients with aortic stenosis undergoing transcatheter aortic valve replacement (TAVR).
Methods
Baseline, 30-day, and 1- and 2-year transthoracic echocardiograms from the PARTNER (Placement of Aortic Transcatheter Valves) 2 SAPIEN 3 registry were analyzed by a consortium of core laboratories and divided into the American Society of Echocardiography DD groups.
Results
Among the 1,750 included, 682 (54.4%) had grade 1 DD, 352 (28.1%) had grade 2 DD, 168 (13.4%) had grade 3 DD, and 51 (4.1%) had indeterminate DD grade. Incremental baseline grades of DD were associated with an increase in combined 1- and 2-year cardiovascular (CV) death/rehospitalization (all p < 0.002) and all-cause death at 2 years (p = 0.01) but not at 1 year. Improvement in DD grade/grade 1 DD at 30 days post-TAVR was seen in 70.8% patients. Patients with improvement in ≥1 grade of DD/grade 1 DD had reduced 1-year CV death/rehospitalization (p < 0.001) and increased 2-year survival (p = 0.01). Baseline grade 3 DD was a predictor of 1-year CV death/rehospitalization (hazard ratio: 2.73; 95% confidence interval: 1.07 to 6.98; p = 0.04). Improvement in DD grade/grade 1 DD at 30 days was protective for 1-year CV death/rehospitalizations (hazard ratio: 0.39; 95% confidence interval: 0.19 to 0.83; p = 0.01).
Conclusions
In the PARTNER 2 SAPIEN 3 registry, baseline DD was a predictor of up to 2 years clinical outcomes in patients who underwent TAVR. Improvement in DD grade at 30 days was associated with improvement in short-term clinical outcomes. (The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - PARTNER II - PARTNERII - S3 Intermediate [PARTNERII S3i]; NCT03222128; PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - High Risk and Nested Registry 7 [PII S3HR/NR7]; NCT03222141).

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

J Am Coll Cardiol: 21 Dec 2020; 76:2940-2951

Evolution of antithrombotic therapy in patients undergoing percutaneous coronary intervention: a 40-year journey.

Cao D, Chandiramani R, Chiarito M, Claessen BE, Mehran R

Since its introduction in 1977, percutaneous coronary intervention has become one of the most commonly performed therapeutic procedures worldwide. Such widespread diffusion, however, would have not been possible without a concomitant evolution of the pharmacotherapies associated with this intervention. Antithrombotic agents are fundamental throughout the management of patients undergoing coronary stent implantation, starting from the procedure itself to the long-term prevention of cardiovascular events. The last 40 years of interventional cardiology have seen remarkable improvements in both drug therapies and device technologies, which largely reflected a progressive understanding of the pathophysiological mechanisms of coronary artery disease, as well as procedure- and device-related adverse events. The purpose of this article is to provide an overview of the important milestones in antithrombotic pharmacology that have shaped clinical practice of today while also providing insights into knowledge gaps and future directions.

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

Eur Heart J: 25 Dec 2020; epub ahead of print

Myocarditis-associated necrotizing coronary vasculitis: incidence, cause, and outcome.

Frustaci A, Alfarano M, Verardo R, Agrati C, ... Letizia C, Chimenti C
Aims 
Necrotizing coronary vasculitis (NCV) is a rare entity usually associated to myocarditis which incidence, cause, and response to therapy is unreported.
Methods and results 
Among 1916 patients with biopsy-proven myocarditis, 30 had NCV. Endomyocardial samples were retrospectively investigated with immunohistochemistry for toll-like receptor 4 (TLR4) and real-time polymerase chain reaction (PCR) for viral genomes. Serum samples were processed for anti-heart autoantibodies (Abs), IL-1β, IL-6, IL-8, tumour necrosis factor (TNF)-α. Identification of an immunologic pathway (including virus-negativity, TLR4-, and Ab-positivity) was followed by immunosuppression. Myocarditis-NCV cohort was followed for 6 months with 2D-echo and/or cardiac magnetic resonance and compared with 60 Myocarditis patients and 30 controls. Increase in left ventricular ejection fraction ≥10% was classified as response to therapy. Control endomyocardial biopsy followed the end of treatment. Twenty-six Myocarditis-NCV patients presented with heart failure; four with electrical instability. Cause of Myocarditis-NCV included infectious agents (10%) and immune-mediated causes (chest trauma 3%; drug hypersensitivity 7%; hypereosinophilic syndrome 3%; primary autoimmune diseases 33%, idiopathic 44%). Abs were positive in immune-mediated Myocarditis-NCV and virus-negative Myocarditis; Myocarditis-NCV patients with Ab+ presented autoreactivity in vessel walls. Toll-like receptor 4 was overexpressed in immune-mediated forms and poorly detectable in viral. Interleukin-1β was significantly higher in Myocarditis-NCV than Myocarditis, the former presenting 24% in-hospital mortality compared with 1.5% of Myocarditis cohort. Immunosuppression induced improvement of cardiac function in 88% of Myocarditis-NCV and 86% of virus-negative Myocarditis patients.
Conclusion 
Necrotizing coronary vasculitis is histologically detectable in 1.5% of Myocarditis. Necrotizing coronary vasculitis includes viral and immune-mediated causes. Intra-hospital mortality is 24%. The immunologic pathway is associated with beneficial response to immunosuppression.

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

Eur Heart J: 22 Dec 2020; epub ahead of print

Association of Age With 10-Year Outcomes After Coronary Surgery in the Arterial Revascularization Trial.

Gaudino M, Di Franco A, Flather M, Gerry S, ... Fremes SE, Taggart DP
Background
The association of age with the outcomes of bilateral internal thoracic arteries (BITAs) versus single internal thoracic arteries (SITAs) for coronary bypass grafting (CABG) remains to be determined.
Objectives
The purpose of this study was to evaluate the association between age and BITA versus SITA outcomes in the Arterial Revascularization Trial.
Methods
The primary endpoints were all-cause mortality and a composite of major adverse events, including all-cause mortality, myocardial infarction, or stroke. Secondary endpoints were bleeding complications and sternal wound complications up to 6 months after surgery. Multivariable fractional polynomials analysis and log-rank tests were used.
Results
Age did not affect any of the explored outcomes in the overall BITA versus SITA comparison in the intention-to-treat analysis and in the analysis based on the number of arterial grafts received. However, when the intention-to-treat analysis was restricted to the populations of patients between age 50 and 70 years, younger patients in the BITA arm had a significantly lower incidence of major adverse events (p = 0.03).
Conclusions
Our results suggest that BITA may improve long-term outcome in younger patients, although more randomized data are needed to confirm this hypothesis.

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

J Am Coll Cardiol: 04 Jan 2021; 77:18-26

Transcatheter Replacement of Transcatheter Versus Surgically Implanted Aortic Valve Bioprostheses.

Landes U, Sathananthan J, Witberg G, De Backer O, ... Leon MB, Webb JG
Background
Surgical aortic valve replacement and transcatheter aortic valve replacement (TAVR) are now both used to treat aortic stenosis in patients in whom life expectancy may exceed valve durability. The choice of initial bioprosthesis should therefore consider the relative safety and efficacy of potential subsequent interventions.
Objectives
The aim of this study was to compare TAVR in failed transcatheter aortic valves (TAVs) versus surgical aortic valves (SAVs).
Methods
Data were collected on 434 TAV-in-TAV and 624 TAV-in-SAV consecutive procedures performed at centers participating in the Redo-TAVR international registry. Propensity score matching was applied, and 330 matched (165:165) patients were analyzed. Principal endpoints were procedural success, procedural safety, and mortality at 30 days and 1 year.
Results
For TAV-in-TAV versus TAV-in-SAV, procedural success was observed in 120 (72.7%) versus 103 (62.4%) patients (p = 0.045), driven by a numerically lower frequency of residual high valve gradient (p = 0.095), ectopic valve deployment (p = 0.081), coronary obstruction (p = 0.091), and conversion to open heart surgery (p = 0.082). Procedural safety was achieved in 116 (70.3%) versus 119 (72.1%) patients (p = 0.715). Mortality at 30 days was 5 (3%) after TAV-in-TAV and 7 (4.4%) after TAV-in-SAV (p = 0.570). At 1 year, mortality was 12 (11.9%) and 10 (10.2%), respectively (p = 0.633). Aortic valve area was larger (1.55 ± 0.5 cm vs. 1.37 ± 0.5 cm; p = 0.040), and the mean residual gradient was lower (12.6 ± 5.2 mm Hg vs. 14.9 ± 5.2 mm Hg; p = 0.011) after TAV-in-TAV. The rate of moderate or greater residual aortic regurgitation was similar, but mild aortic regurgitation was more frequent after TAV-in-TAV (p = 0.003).
Conclusions
In propensity score-matched cohorts of TAV-in-TAV versus TAV-in-SAV patients, TAV-in-TAV was associated with higher procedural success and similar procedural safety or mortality.

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

J Am Coll Cardiol: 04 Jan 2021; 77:1-14

Aortic Valve Replacement in Low-Risk Patients With Severe Aortic Stenosis Outside Randomized Trials.

Alperi A, Voisine P, Kalavrouziotis D, Dumont E, ... Mohammadi S, Rodés-Cabau J
Background
Recent randomized trials including low-risk patients showed positive results for transcatheter aortic valve replacement (TAVR) compared to surgical aortic valve replacement (SAVR), but patients with non-tricuspid aortic valve (NTAV), severe coronary artery disease (SevCAD), and those requiring concomitant mitral/tricuspid valve (CMTV) or concomitant ascending aorta replacement (CAAR) interventions were excluded.
Objectives
This study sought to evaluate the presence and impact of the main clinical variables not evaluated in TAVR versus SAVR trials (NTAV, SevCAD, and CMTV or CAAR intervention) in a large series of consecutive low-risk patients with severe aortic stenosis (SAS) undergoing SAVR.
Methods
Single-center study including consecutive patients with SAS and low surgical risk (Society of Thoracic Surgeons score of <4%) undergoing SAVR. Baseline, procedural characteristics, and 30-day outcomes were prospectively collected.
Results
Of 6,772 patients with SAS who underwent SAVR between 2000 and 2019, 5,310 (78.4%) exhibited a low surgical risk (mean Society of Thoracic Surgeons score: 1.94 ± 0.87%). Of these, 2,165 patients (40.8%) had at least 1 of the following: NTAV (n = 1,468, 27.6%), SevCAD (n = 307, 5.8%), CMTV (n = 306, 5.8%), and CAAR (n = 560, 10.5%). The 30-day mortality and stroke rates for the overall low-risk SAS cohort were 1.9% and 2.4%, respectively. The mortality rate was similar in the SevCAD (2.6%) and CAAR (2.1%) groups versus the rest of the cohort (odds ratio [OR]: 1.79; 95% confidence interval [CI]: 0.85 to 3.75, and OR: 1.64; 95% CI: 0.88 to 3.05, respectively), lower in the NTAV group (0.9%; OR: 0.42; 95% CI: 0.22 to 0.81), and higher in the CMTV group (5.9%; OR: 2.61; 95% CI: 1.51 to 4.5).
Conclusions
In a real-world setting, close to one-half of the low-risk patients with SAS undergoing SAVR exhibited at least 1 major criterion not evaluated in TAVR versus SAVR randomized trials. Clinical outcomes were better than or similar to those predicted by surgical scores in all groups but those patients requiring CMTV intervention. These results may help determine the impact of implementing the results of TAVR-SAVR trials in real practice and may inform future trials in specific groups.

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

J Am Coll Cardiol: 18 Jan 2021; 77:111-123

Predictive Value of the Residual SYNTAX Score in Patients With Cardiogenic Shock.

Barthélémy O, Rouanet S, Brugier D, Vignolles N, ... Thiele H, Montalescot G
Background
In hemodynamically stable patients, complete revascularization (CR) following percutaneous coronary intervention (PCI) is associated with a better prognosis in chronic and acute coronary syndromes.
Objectives
This study sought to assess the extent, severity, and prognostic value of remaining coronary stenoses following PCI, by using the residual SYNTAX score (rSS), in patients with cardiogenic shock (CS) related to myocardial infarction (MI).
Methods
The CULPRIT-SHOCK (Culprit Lesion Only Percutaneous Coronary Intervention [PCI] Versus Multivessel PCI in Cardiogenic Shock) trial compared a multivessel PCI (MV-PCI) strategy with a culprit lesion-only PCI (CLO-PCI) strategy in patients with multivessel coronary artery disease who presented with MI-related CS. The rSS was assessed by a central core laboratory. The study group was divided in 4 subgroups according to tertiles of rSS of the participants, thereby isolating patients with an rSS of 0 (CR). The predictive value of rSS for the 30-day primary endpoint (mortality or severe renal failure) and for 30-day and 1-year mortality was assessed using multivariate logistic regression.
Results
Among the 587 patients with an rSS available, the median rSS was 9.0 (interquartile range: 3.0 to 17.0); 102 (17.4%), 100 (17.0%), 196 (33.4%), and 189 (32.2%) patients had rSS = 0, 0 < rSS ≤5, 5 < rSS ≤14, and rSS >14, respectively. CR was achieved in 75 (25.2%; 95% confidence interval [CI]: 20.3% to 30.5%) and 27 (9.3%; 95% CI: 6.2% to 13.3%) of patients treated using the MV-PCI and CLO-PCI strategies, respectively. After multiple adjustments, rSS was independently associated with 30-day mortality (adjusted odds ratio per 10 units: 1.49; 95% CI: 1.11 to 2.01) and 1-year mortality (adjusted odds ratio per 10 units: 1.52; 95% CI: 1.11 to 2.07).
Conclusions
Among patients with multivessel disease and MI-related CS, CR is achieved only in one-fourth of the patients treated using an MV-PCI strategy. and the residual SYNTAX score is independently associated with early and late mortality.

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

J Am Coll Cardiol: 18 Jan 2021; 77:144-155

VEGF-B Promotes Endocardium-Derived Coronary Vessel Development and Cardiac Regeneration.

Räsänen M, Sultan I, Paech J, Hemanthakumar KA, ... Kivelä R, Alitalo K
Background
Recent discoveries have indicated that, in the developing heart, sinus venosus and endocardium provide major sources of endothelium for coronary vessel growth that supports the expanding myocardium. Here we set out to study the origin of the coronary vessels that develop in response to vascular endothelial growth factor B (VEGF-B) in the heart and the effect of VEGF-B on recovery from myocardial infarction.
Methods
We used mice and rats expressing a VEGF-B transgene, VEGF-B-gene-deleted mice and rats, apelin-CreERT, and natriuretic peptide receptor 3-CreERT recombinase-mediated genetic cell lineage tracing and viral vector-mediated VEGF-B gene transfer in adult mice. Left anterior descending coronary vessel ligation was performed, and 5-ethynyl-2\'-deoxyuridine-mediated proliferating cell cycle labeling; flow cytometry; histological, immunohistochemical, and biochemical methods; single-cell RNA sequencing and subsequent bioinformatic analysis; microcomputed tomography; and fluorescent- and tracer-mediated vascular perfusion imaging analyses were used to study the development and function of the VEGF-B-induced vessels in the heart.
Results
We show that cardiomyocyte overexpression of VEGF-B in mice and rats during development promotes the growth of novel vessels that originate directly from the cardiac ventricles and maintain connection with the coronary vessels in subendocardial myocardium. In adult mice, endothelial proliferation induced by VEGF-B gene transfer was located predominantly in the subendocardial coronary vessels. Furthermore, VEGF-B gene transduction before or concomitantly with ligation of the left anterior descending coronary artery promoted endocardium-derived vessel development into the myocardium and improved cardiac tissue remodeling and cardiac function.
Conclusions
The myocardial VEGF-B transgene promotes the formation of endocardium-derived coronary vessels during development, endothelial proliferation in subendocardial myocardium in adult mice, and structural and functional rescue of cardiac tissue after myocardial infarction. VEGF-B could provide a new therapeutic strategy for cardiac neovascularization after coronary occlusion to rescue the most vulnerable myocardial tissue.



Circulation: 04 Jan 2021; 143:65-77

Comparison of Self-Expanding Bioprostheses for Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis: SCOPE 2 Randomized Clinical Trial.

Tamburino C, Bleiziffer S, Thiele H, Scholtz S, ... Hengstenberg C, Capodanno D
Background
Few randomized trials have compared bioprostheses for transcatheter aortic valve replacement, and no trials have compared bioprostheses with supra-annular design. The SCOPE 2 trial (Safety and Efficacy Comparison of Two TAVI Systems in a Prospective Randomized Evaluation 2) was designed to compare the clinical outcomes of the ACURATE neo and CoreValve Evolut bioprostheses for transcatheter aortic valve replacement.
Methods
SCOPE 2 was a randomized trial performed at 23 centers in 6 countries between April 2017 and April 2019. Patients ≥75 years old with an indication for transfemoral transcatheter aortic valve replacement as agreed by the heart team were randomly assigned to receive treatment with either the ACURATE neo (n=398) or the CoreValve Evolut bioprostheses (n=398). The primary end point, powered for noninferiority of the ACURATE neo bioprosthesis, was all-cause death or stroke at 1 year. The key secondary end point, powered for superiority of the ACURATE neo bioprosthesis, was new permanent pacemaker implantation at 30 days.
Results
Among 796 randomized patients (mean age, 83.2±4.3 years; mean Society of Thoracic Surgeons Predicted Risk of Mortality score, 4.6±2.9%), clinical follow-up information was available for 778 (98%) patients. Within 1 year, the primary end point occurred in 15.8% of patients in the ACURATE neo group and in 13.9% of patients in the CoreValve Evolut group (absolute risk difference, 1.8%, upper 1-sided 95% confidence limit, 6.1%; =0.0549 for noninferiority). The 30-day rates of new permanent pacemaker implantation were 10.5% in the ACURATE neo group and 18.0% in the CoreValve Evolut group (absolute risk difference, -7.5% [95% CI, -12.4 to -2.60]; =0.0027). No significant differences were observed in the components of the primary end point. Cardiac death at 30 days (2.8% versus 0.8%; =0.03) and 1 year (8.4% versus 3.9%; =0.01), and moderate or severe aortic regurgitation at 30 days (10% versus 3%; =0.002) were significantly increased in the ACURATE neo group.
Conclusions
Transfemoral transcatheter aortic valve replacement with the self-expanding ACURATE neo did not meet noninferiority compared with the self-expanding CoreValve Evolut in terms of all-cause death or stroke at 1 year, and it was associated with a lower incidence of new permanent pacemaker implantation. In secondary analyses, the ACURATE neo was associated with more moderate or severe aortic regurgitation at 30 days and cardiac death at 30 days and 1 year. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03192813.



Circulation: 21 Dec 2020; 142:2431-2442

Clinical Efficacy and Safety of Alirocumab after Acute Coronary Syndrome According to Achieved Level of Low-Density Lipoprotein Cholesterol: A Propensity Score-Matched Analysis of the ODYSSEY OUTCOMES Trial.

Schwartz GG, Steg PG, Bhatt DL, Bittner VA, ... Szarek M, ODYSSEY OUTCOMES Committees and Investigators

Recent international guidelines have lowered recommended target levels of low-density lipoprotein-cholesterol (LDL-C) for patients at very high risk for major adverse cardiovascular events (MACE). However, uncertainty persists whether additional benefit results from achieved LDL-C levels below conventional targets. Inferences from prior analyses are limited because patients who achieve lower versus higher LDL-C on lipid-lowering therapy differ in other characteristics prognostic for MACE and because few achieved very low LDL-C levels. To overcome these limitations, we performed a propensity score matching (PSM) analysis of the ODYSSEY OUTCOMES trial which compared alirocumab with placebo in 18,924 patients with recent acute coronary syndrome (ACS) receiving intensive or maximum-tolerated statin treatment.Patients on alirocumab were classified in prespecified strata of LDL-C achieved at 4 months of treatment: <25 (n=3357), 25-50 (n=3692) or >50 mg/dL (n=2197). For each stratum, MACE (coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, or hospitalization for unstable angina) after month 4 was compared in patients receiving placebo with similar baseline characteristics and adherence, using 1:1 PSM.Across achieved LDL-C strata of the alirocumab group patients differed by baseline LDL-C, lipoprotein(a), use of intensive statin therapy, study medication adherence, and other demographic, medical history, biometric, and laboratory criteria. After PSM, characteristics were similar in corresponding patients of the alirocumab and placebo groups. Treatment hazard ratio (HR), 95% confidence interval (CI), and absolute risk reduction (ARR, number per 100 patient-years) for MACE were similar in those with achieved LDL-C <25 mg/dL (HR, 0.74; 95% CI, 0.62 to 0.89; ARR, 0.92) or 25-50 mg/dL (HR, 0.74; 95% CI, 0.64 to 0.87; ARR, 1.05). Patients with achieved LDL-C >50 mg/dL had poorer adherence and derived less benefit (HR, 0.87; 95% CI, 0.73 to 1.04; ARR, 0.62). No safety concerns were associated with a limited period of LDL-C levels <15 mg/dL.After accounting for differences in baseline characteristics and adherence, patients treated with alirocumab who achieved LDL-C levels <25 mg/dL did not appear to derive further reduction in the risk of MACE compared to those who achieved LDL-C levels of 25-50 mg/dL.URL: https://www.clinicaltrials.gov Unique identifier: NCT01663402.



Circulation: 12 Jan 2021; epub ahead of print

Aortic Pulse Wave Velocity Predicts Cardiovascular Events and Mortality in Patients Undergoing Coronary Angiography: A Comparison of Invasive Measurements and Noninvasive Estimates.

Hametner B, Wassertheurer S, Mayer CC, Danninger K, Binder RK, Weber T

Aortic pulse wave velocity (PWV) is directly related to arterial stiffness. Different methods for the determination of PWV coexist. The aim of this prospective study was to evaluate the prognostic value of PWV in high-risk patients with suspected coronary artery disease undergoing invasive angiography and to compare 3 different methods for assessing PWV. In 1040 patients, invasive PWV (iPWV) was measured during catheter pullback. Additionally, PWV was estimated with a model incorporating age, central systolic blood pressure, and pulse waveform characteristics obtained from noninvasive measurements (estimated PWV). As a third method, PWV was calculated with a formula solely based on age and blood pressure (formula-based PWV). Survival analysis was based on continuous PWV as well as using cutoff values. After a median follow-up duration of 1565 days, 24% of the patients reached the combined end point (cardiovascular events or mortality). Cox proportional hazard ratios per 1 SD were 1.35 for iPWV, 1.37 for estimated PWV, and 1.28 for formula-based PWV (<0.0001 for all 3 methods) in univariate analysis, remaining statistically significant after comprehensive multivariable adjustments. In a model including a modified risk score for coronary artery disease, iPWV and estimated PWV remained borderline significant. The net reclassification improvement was significant for iPWV (0.173), formula-based PWV (0.181), and estimated PWV (0.230). All 3 methods for the determination of PWV predicted cardiovascular events and mortality in patients with suspected coronary artery disease. This indicates that iPWV as well as both noninvasive estimation methods are suitable for the assessment of arterial stiffness, bearing in mind their individual characteristics.



Hypertension: 03 Jan 2021:HYPERTENSIONAHA12015336; epub ahead of print

Association Between Muscle Quality Measured by Abdominal Computed Tomography and Subclinical Coronary Atherosclerosis.

Jung Lee M, Kim HK, Hee Kim E, Jin Bae S, ... Kim MJ, Choe J
Objective
Low muscle mass was known to be associated with cardiovascular diseases. However, only few studies investigated the association between muscle quality and subclinical coronary atherosclerosis. Thus, we evaluated whether muscle quality measured by abdominal computed tomography is associated with the risk of coronary artery calcification. Approach and
Results:
We conducted a cross-sectional study on 4068 subjects without cardiovascular disease who underwent abdominal and coronary computed tomography between 2012 and 2013 during health examinations. The cross-sectional area of the skeletal muscle was measured at the L3 level (total abdominal muscle area, total abdominal muscle area) and segmented into normal attenuation muscle area, low attenuation muscle area, and intramuscular adipose tissue. We calculated the normal attenuation muscle area/total abdominal muscle area index, of which a higher value reflected a higher proportion of good quality muscle (normal attenuation muscle area) and a lower proportion of myosteatosis (low attenuation muscle area and intramuscular adipose tissue). In women, as the normal attenuation muscle area/total abdominal muscle area quartiles increased, the odds ratios (95% CIs) for significant coronary artery calcification (>100) consistently decreased (0.44 [0.24-0.80], 0.39 [0.19-0.81], 0.34 [0.12-0.98]; =0.003) after adjusting for cardiovascular risk factors including visceral fat area and insulin resistance. In men, the odds ratios in the Q2 group were significantly lower than those in the Q1, but the association was attenuated in Q3-4 after adjustment.
Conclusions
A higher proportion of good quality muscle was strongly associated with a lower prevalence of significant coronary artery calcification after adjustment, especially in women. Poor skeletal muscle quality may be an important risk factor for subclinical coronary atherosclerosis.



Arterioscler Thromb Vasc Biol: 23 Dec 2020:ATVBAHA120315054; epub ahead of print

F-Sodium Fluoride Positron Emission Tomography Activity Predicts the Development of New Coronary Artery Calcifications.

Bellinge JW, Francis RJ, Lee SC, Phillips M, ... Watts GF, Schultz CJ
Objective
The coronary calcium score (CCS) predicts cardiovascular disease risk in individuals with diabetes, and rate of progression of CCS is an additional and incremental marker of risk. F-sodium fluoride positron emission tomography (F-NaF PET) detects early and active calcifications within the vasculature. We aimed to ascertain the relationship between F-NaF PET activity and CCS progression in patients with diabetes. Approach and
Results:
We identified individuals between 50 and 80 years with diabetes and no history of clinical coronary artery disease. Those with a CCS ≥10 were invited to undergo F-NaF PET scanning and then repeat CCS >2 years later. F-NaF PET and CCS analysis were performed on a per-coronary and a per-patient level. We compared the proportion of CCS progressors in F-NaF PET-positive versus F-NaF PET-negative coronary arteries. Forty-one participants with 163 coronary arteries underwent follow-up CCS 2.8±0.5 years later. F-NaF PET-positive coronary arteries (n=52) were more likely to be CCS progressors, compared with negative coronary arteries (n=111; 86.5% versus 52.3%, <0.001). Adjusting for baseline CCS, F-NaF PET-positive disease was an independent predictor of subsequent CCS progression (odds ratio, 2.92 [95% CI, 1.32-6.45], =0.008). All subjects (100%, 15/15) with ≥2 F-NaF-positive coronary arteries progressed in CCS.
Conclusions
In subjects with diabetes, F-NaF PET positivity at baseline, independently predicted the progression of calcifications within the coronary arteries 2.8 years later. These findings suggest F-NaF PET may be a promising technique for earlier identification of patients at higher risk of cardiovascular events.



Arterioscler Thromb Vasc Biol: 30 Dec 2020; 41:534-541

Effect of coronary flow on intracoronary alteplase: a prespecified analysis from a randomised trial.

Maznyczka AM, McCartney P, Duklas P, McEntegart M, ... Berry C, T-TIME (Trial of low-dose adjunctive alTeplase during primary PCI) investigators
Objectives
Persistently impaired culprit artery flow (Methods
In T-TIME (trial of low-dose adjunctive alTeplase during primary PCI), patients ≤6 hours from onset of ST-elevation myocardial infarction (STEMI) were randomised to placebo, alteplase 10 mg or alteplase 20 mg, administered by infusion into the culprit artery, pre-stenting. In this prespecified, secondary analysis, coronary flow was assessed angiographically at the point immediately before drug administration. Microvascular obstruction, myocardial haemorrhage and infarct size were assessed by cardiovascular magnetic resonance (CMR) at 2-7 days and 3 months.
Results
TIMI flow was assessed after first treatment (balloon angioplasty/aspiration thrombectomy), immediately pre-drug administration, in 421 participants (mean age 61±10 years, 85% male) and was 3, 2 or 1 in 267, 134 and 19 participants respectively. In patients with TIMI flow ≤2 pre-drug, there was higher incidence of microvascular obstruction with alteplase (alteplase 20 mg (53.1%) and 10 mg (59.5%) combined versus placebo (34.1%); OR=2.47 (95% CI 1.16 to 5.22, p=0.018) interaction p=0.005) and higher incidence of myocardial haemorrhage (alteplase 20 mg (53.1%) and 10 mg (57.9%) combined vs placebo (27.5%); OR=3.26 (95% CI 1.44 to 7.36, p=0.004) interaction p=0.001). These effects were not observed in participants with TIMI 3 flow pre-drug. There were no interactions between TIMI flow pre-drug, alteplase and 3-month CMR findings.
Conclusion
In patients with impaired culprit artery flow (Trial registration number
NCT02257294.

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

Heart: 11 Jan 2021; epub ahead of print

Single high-sensitivity troponin levels to assess patients with potential acute coronary syndromes.

Barnes C, Fatovich DM, Macdonald SPJ, Alcock RF, ... Schultz CJ, Hillis GS
Objective
We tested the hypothesis that patients with a potential acute coronary syndrome (ACS) and very low levels of high-sensitivity cardiac troponin I can be efficiently and safely discharged from the emergency department after a single troponin measurement.
Methods
This prospective cohort study recruited 2255 consecutive patients aged ≥18 years presenting to the Emergency Department, Royal Perth Hospital, Western Australia, with chest pain without high-risk features but requiring the exclusion of ACS. Patients were managed using a guideline-recommended pathway or our novel Single Troponin Accelerated Triage (STAT) pathway. The primary outcome was the percentage of patients discharged in <3 hours. Secondary outcomes included the duration of observation and death or acute myocardial infarction in the next 30 days.
Results
The study enrolled 1131 patients to the standard cohort and 1124 to the STAT cohort. Thirty-eight per cent of the standard cohort were discharged directly from emergency department compared with 63% of the STAT cohort (p<0.001). The median duration of observation was 4.3 (IQR 3.3-7.1) hours in the standard cohort and 3.6 (2.6-5.4) hours in the STAT cohort (p<0.001), with 21% and 38% discharged in <3 hours, respectively (p<0.001). No patients discharged directly from the emergency department died or suffered an acute myocardial infarction within 30 days in either cohort.
Conclusions
Among low-risk patients with a potential ACS, a pathway which incorporates early discharge based on a single very low level of high-sensitivity cardiac troponin increases the proportion of patients discharged directly from the emergency department, reduces length of stay and is safe.
Trial registration number
ACTRN12618000797279.

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

Heart: 11 Jan 2021; epub ahead of print

The new role of diagnostic angiography in coronary physiological assessment.

Ghobrial M, Haley HA, Gosling R, Rammohan V, ... Gunn JP, Morris PD

The role of \'stand-alone\' coronary angiography (CAG) in the management of patients with chronic coronary syndromes is the subject of debate, with arguments for its replacement with CT angiography on the one hand and its confinement to the interventional cardiac catheter laboratory on the other. Nevertheless, it remains the standard of care in most centres. Recently, computational methods have been developed in which the laws of fluid dynamics can be applied to angiographic images to yield \'virtual\' (computed) measures of blood flow, such as fractional flow reserve. Together with the CAG itself, this technology can provide an \'all-in-one\' anatomical and functional investigation, which is particularly useful in the case of borderline lesions. It can add to the diagnostic value of CAG by providing increased precision and reduce the need for further non-invasive and functional tests of ischaemia, at minimal cost. In this paper, we place this technology in context, with emphasis on its potential to become established in the diagnostic workup of patients with suspected coronary artery disease, particularly in the non-interventional setting. We discuss the derivation and reliability of angiographically derived fractional flow reserve (CAG-FFR) as well as its limitations and how CAG-FFR could be integrated within existing national guidance. The assessment of coronary physiology may no longer be the preserve of the interventional cardiologist.

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

Heart: 07 Jan 2021; epub ahead of print

Coronary revascularisation in patients with ischaemic cardiomyopathy.

Ryan M, Morgan H, Petrie MC, Perera D

Heart failure resulting from ischaemic heart disease is associated with a poor prognosis despite optimal medical treatment. Despite this, patients with ischaemic cardiomyopathy have been largely excluded from randomised trials of revascularisation in stable coronary artery disease. Revascularisation has multiple potential mechanisms of benefit, including the reversal of myocardial hibernation, suppression of ventricular arrhythmias and prevention of spontaneous myocardial infarction. Coronary artery bypass grafting is considered the first-line mode of revascularisation in these patients; however, evidence from the Surgical Treatment of Ischaemic Heart Failure (STICH) trial showed a reduction in mortality, though this only became apparent with extended follow-up due to an excess of early adverse events in the surgical arm. There is currently no randomised controlled trial evidence for percutaneous coronary intervention in patients with ischaemic cardiomyopathy; however, the REVIVED-BCIS2 trial has recently completed recruitment and will address this gap in the evidence. Future directions include (1) clinical trials of revascularisation in patients hospitalised with heart failure, (2) defining the role of viability and ischaemia testing in heart failure, (3) studies to enhance the understanding of the mechanistic effects of revascularisation and (4) generating models to refine pre- and post-revascularisation risk prediction.

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

Heart: 11 Jan 2021; epub ahead of print

Meta-Analysis Comparing Culprit-Only Versus Complete Multivessel Percutaneous Coronary Intervention in Patients With ST-Elevation Myocardial Infarction.

Ullah W, Zahid S, Nadeem N, Gowda S, ... Alam M, Fischman DL

ST-segment elevation myocardial infarction (STEMI) in patients with concomitant multivessel coronary artery disease is associated with poor prognosis. We sought to determine the merits of percutaneous coronary intervention of the culprit-only revascularization (COR) compared with multivessel revascularization (MVR) approach. Multiple databases were queried to identify relevant articles. Data were analyzed using a random-effect model to calculate unadjusted odds ratio (OR) and relative risk. A total of 28 studies comprising 26,892 patients, 18,377 in the COR and 8,515 in the MVR group were included. The mean age of patients was 63 years, comprising 72% of male patients. The baseline characteristics of the 2 treatment groups were comparable. On a median follow-up of 1-year, COR was associated with a significantly higher odds of major adverse cardiovascular events (MACE; OR 1.36, 95% confidence interval [CI] 1.10 to 1.70, p = 0.005), angina (OR 2.28, 95% CI 1.83 to 2.85, p ≤ 0.00001) and revascularization (OR 1.76, 95% CI 1.22 to 2.54, p = 0.002) compared with patients undergoing MVR for STEMI. The all-cause mortality (OR 1.18, 95% CI 0.91 to 1.53, p = 0.22), cardiovascular mortality (OR 1.30, 95% CI 0.98 to 1.72, p = 0.07), rate of heart failure (OR 1.17, 95% CI 0.86 to 1.59, p = 0.31), need for coronary artery bypass graft (CABG) (OR 1.47, 95% CI 0.82 to 2.64, p = 0.19), repeat myocardial infarction (MI) events (OR 1.23, 95% CI 0.93 to 1.64, p = 0.15) and risk of stroke (OR 1.27 95% CI 0.68 to 2.34, p = 0.45%) were similar between the two groups. A subgroup analysis based on follow-up duration and study design mostly followed the results of the pooled analysis except that the risk of repeat MI events were significantly lower in the MVR group across RCTs (OR 1.46, 95% CI 1.10 to 1.94, p = 0.009). In contrast to the culprit-only approach, MVR in patients with STEMI is associated with a significant reduction in MACE, angina and need for revascularization.

Copyright © 2020 Elsevier Inc. All rights reserved.

Am J Cardiol: 14 Jan 2021; 139:34-39

Prognostic Value of Baseline Sarcopenia on 1-year Mortality in Patients Undergoing Transcatheter Aortic Valve Implantation.

Yoon YH, Ko Y, Kim KW, Kang DY, ... Park DW, Park SJ

There is limited data regarding the association between sarcopenia and clinical outcomes in patients who underwent transcatheter aortic valve implantation (TAVI). From the prospective ASAN-TAVI registry, we evaluated a total of 522 patients with severe aortic stenosis who underwent TAVI between March 2010 and November 2018. Routine pre-TAVI computed tomography scan was used to calculate the skeletal muscle index (SMI), which was defined as skeletal muscle area at the L3 level divided by height squared; subject patients were classified into the gender-specific tertile groups of SMI. The patients\' mean age was 79 years and 49% were men. Mean SMI values were 41.3 ± 6.7 cm/m in men and 34.1 ± 6.5 cm/m in women. The Kaplan-Meier estimates of all-cause mortality at 12 months were higher in the low-tertile group than in the mid- and high-tertile groups (15.5%, 7.1%, and 6.2%, respectively; p = 0.036). In multivariate analysis, low-tertile of SMI was an independent predictor of mortality (vs high-tertile of SMI, hazard ratio 2.69; 95% confidence interval, 1.18 to 6.12; p = 0.019). The all-cause mortality was substantially higher in the groups with high-surgical risk plus low SMI tertile. The risk assessment with addition of SMI on conventional STS-PROM score was significantly improved by statistical measures of model reclassification and discrimination. In patients who underwent TAVI, sarcopenia measured by SMI was significantly associated with an increased risk of 1-year mortality. The prognostic impact of SMI-measured sarcopenia was more prominent in patients with high surgical risks.

Copyright © 2020 Elsevier Inc. All rights reserved.

Am J Cardiol: 14 Jan 2021; 139:79-86

Evaluation of a Low-Dose Radiation Protocol During Transcatheter Aortic Valve Implantation.

Michel JM, Hashorva D, Kretschmer A, Alvarez-Covarrubias HA, ... Joner M, Kasel AM

We aimed to evaluate the efficacy and safety of a low-dose imaging protocol to reduce intraprocedural radiation during transcatheter aortic valve implantation (TAVI). Observational analysis: 802 transfemoral TAVI patients receiving balloon-expandable devices ≥23 mm at a high-volume centre. After propensity score matching, a standard-dose group (SD, n = 333) treated between January 2014 and February 2016 was compared with a low-dose group (LD, n = 333) treated between August 2017 and March 2019 after departmental uptake of a low-dose imaging protocol (reduced field size, high table height, use of \"fluoro save,\" 3.75 frames/second acquisition, increased filtering). Primary end point was dose-area product (DAP). Secondary safety end points were VARC-2 device success and a composite of in-hospital complications. The LD protocol was associated with lower DAP (4.64 [2.93, 8.42] vs 22.73 [12.31, 34.58] Gy⋅cm, p <0.001) and fluoroscopy time (10.4 [8.1, 13.9] vs 11.5 [9.1, 15.3] minutes, p = 0.001). Contrast use was higher in the LD group (LD 110 [94, 130] vs SD 100 [80, 135] milliliters, p = 0.042). Device success (LD 88.3% vs SD 91.3%, p = 0.25), and the composite end point (LD 8.1% vs SD 11.4%, p = 0.19) were similar. In multivariate analysis, the low-dose protocol was associated with a 19.8 Gy⋅cm reduction in procedural DAP (p <0.001). In conclusion, compared with standard imaging, a low-dose protocol for TAVI significantly reduced radiation dose without compromising outcomes.

Copyright © 2020 Elsevier Inc. All rights reserved.

Am J Cardiol: 14 Jan 2021; 139:71-78

Meta-analysis Comparing Early Outcomes Following Transcatheter Aortic Valve Implantation With the Evolut Versus Sapien 3 Valves.

Alperi A, Faroux L, Muntané-Carol G, Rodés-Cabau J

We aimed to compare the early (in-hospital/30-day) outcomes (major periprocedural complications, device success/valve performance, and mortality) following transcatheter aortic valve implantation with the Sapien 3 versus Evolut transcatheter valve systems. This was a systematic review from PubMed and EMBASE databases for studies reporting raw data or estimates. The outcomes analyzed were (1) in-hospital/30-day major periprocedural complications, (2) device success and valve performance, and (3) mortality. The outcomes were defined according to VARC-2 criteria. A total of 24,628 transcatheter aortic valve implantation patients from 9 studies (1 randomized, 8 observational [5 case- or propensity-matched analyses]) were included: 12,411 and 12,217 patients had Sapien 3 and Evolut valve implantation, respectively. There were no differences between devices regarding in-hospital/30-day stroke (risk ratio [RR] 0.95, 95% confidence interval [CI] 0.34 to 2.66), major vascular complications (RR 1.03, 95% CI 0.63 to 1.68), acute kidney injury (RR 1.17, 95% CI 0.78 to 1.77), device success (RR 1.00, 95% CI 0.97 to 1.04) and moderate-severe residual aortic regurgitation (RR 0.49, 95% CI 0.20 to 1.17). Sapien 3 recipients exhibited lower risk of permanent pacemaker implantation (RR 0.66, 95% CI 0.55 to 0.80), a higher risk of life-threatening bleeding (RR 1.82, 95% CI 1.18 to 2.80), and higher residual transvalvular gradients (mean difference 3.95 mmHg, 95% CI 3.37 to 4.56). A lower risk of in-hospital/30-day mortality was observed for Sapien 3 (RR 0.79, 95% CI 0.69 to 0.90). In conclusion, the similarities in device success rate and major periprocedural complications (except for a higher and lower risk of permanent pacemaker implantation and life-threatening bleeding, respectively, with the Evolut system) support the lack of a valve type effect accounting for the increased mortality risk observed with the Evolut valve.

Copyright © 2020 Elsevier Inc. All rights reserved.

Am J Cardiol: 14 Jan 2021; 139:87-96

Meta-Analysis of Early Intervention Versus Conservative Management for Asymptomatic Severe Aortic Stenosis.

Kumar A, Majmundar M, Doshi R, Kansara T, ... Panaich SS, Thourani VH

The main objective was to determine the optimal strategy for managing asymptomatic severe aortic stenosis between early intervention versus conservative management. We performed a systematic electronic search of the PubMed and Cochrane databases from the inception of the database to May 31, 2020. The Mantel Haenszel method with the Paule-Mandel estimator of Tau and Hartung-Knapp adjustment were used to calculate relative risk (RR) with a 95% confidence interval (CI) and 95% prediction interval. P curve analysis was used to assess publication bias and estimate the true effect of an intervention. All analysis was carried out using R version 3.6.2. A total of 9 studies were included in the final analysis, consisting of 1,775 patients with early intervention and 3,040 patients with conservative management. Early intervention as compared with conservative management was associated with reduced risk of all-cause mortality (RR 0.36, 95% CI 0.24 to 0.53), cardiac mortality (RR 0.36, 95% CI 0.27 to 0.48) and noncardiac mortality (RR 0.40, 95% CI 0.28 to 0.56). There was no difference in the risk of sudden cardiac death (RR 0.46, 95% CI 0.15 to 1.40), stroke (RR 0.79, 95% CI 0.17 to 3.64), myocardial infarction (RR 0.44, 95% CI 0.01 to 16.82) or heart failure hospitalization (RR 0.18, 95% CI 0.01 to 5.29) with early intervention compared with conservative management. In conclusion, early intervention is associated with reduced all-cause, cardiovascular, and noncardiovascular mortality without increasing any procedure-related clinical outcomes among asymptomatic severe AS patients. Hence, this meta-analysis supports early intervention instead of watchful waiting for the management of asymptomatic severe AS. This systematic review and meta-analysis was registered with PROSPERO- CRD42020188439.

Copyright © 2020 Elsevier Inc. All rights reserved.

Am J Cardiol: 31 Dec 2020; 138:85-91

Meta-Analysis of Bioprosthetic Valve Thrombosis After Transcatheter Aortic Valve Implantation.

Rheude T, Pellegrini C, Stortecky S, Marwan M, ... Cassese S, Joner M

Bioprosthetic valve thrombosis may complicate transcatheter aortic valve implantation (TAVI). This meta-analysis sought to evaluate the prevalence and clinical impact of subclinical leaflet thrombosis (SLT) and clinical valve thrombosis (CVT) after TAVI. We summarized diagnostic strategies, prevalence of SLT and/or CVT and estimated their impact on the risk of all-cause death and stroke. Twenty studies with 12,128 patients were included. The prevalence of SLT and CVT was 15.1% and 1.2%, respectively. The risk of all-cause death was not significantly different between patients with SLT (relative risk [RR] 0.77; p = 0.22) and CVT (RR 1.29; p = 0.68) compared with patients without. The risk of stroke was higher in patients with CVT (RR 7.51; p <0.001) as compared with patients without, while patients with SLT showed no significant increase in the risk of stroke (RR 1.81; p = 0.17). Reduced left ventricular function was associated with increased prevalence, while oral anticoagulation was associated with reduced prevalence of bioprosthetic valve thrombosis. Bioprosthetic valve thrombosis is frequent after TAVI, but does not increase the risk of death. Clinical valve thrombosis is associated with a significantly increased risk of stroke. Future studies should focus on prevention and treatment of bioprosthetic valve thrombosis.

Copyright © 2020 Elsevier Inc. All rights reserved.

Am J Cardiol: 31 Dec 2020; 138:92-99

Safety and Efficacy of 1-Month Dual Antiplatelet Therapy (Ticagrelor + Aspirin) Followed by 23-Month Ticagrelor Monotherapy in Patients Undergoing Staged Percutaneous Coronary Intervention (A Sub-Study from GLOBAL LEADERS).

Kawashima H, Tomaniak M, Ono M, Wang R, ... Onuma Y, Serruys PW

Patients undergoing staged percutaneous coronary intervention (SPCI) are exposed to extended duration of antiplatelet therapy, and a novel aspirin-free antiplatelet regimen after SPCI should be specifically evaluated among these patients. This is a prespecified substudy of the GLOBAL LEADERS which is a randomized, open-label trial, comparing an experimental regimen of 1-month dual antiplatelet therapy (DAPT; ticagrelor and aspirin) followed by 23-month ticagrelor monotherapy to a reference regimen of 12-month DAPT followed by 12-month aspirin monotherapy. Patients were stratified according to whether or not SPCI was performed. The impact of the timing of SPCI on clinical outcomes was also investigated. Of 15,968 randomized patients, 1,651 patients underwent SPCI within 3 months. These patients with SPCI had a significantly higher risk of bleeding and ischemic endpoints than those without SPCI. In patients undergoing SPCI, the primary endpoint (composite of all-cause death or new Q-wave myocardial infarction at 2 years) and secondary safety endpoint (Bleeding Academic Research Consortium [BARC]-defined bleeding 3 or 5) were similar in the 2 regimens. However, in patients presenting with acute coronary syndrome (ACS), the experimental regimen reduced a risk of BARC 3 or 5 bleeding (1.8% vs 4.5%; HR 0.387; 95% CI 0.179 to 0.836; p = 0.016). In patients undergoing SPCI later than 10 days after index procedure, this risk reduction was still prominent (0.8% vs 2.3%; HR 0.321; 95% CI 0.116 to 0.891; p = 0.029). In conclusion, patients undergoing SPCI are at high risk and may need special attention from clinicians. In ACS patients undergoing SPCI, a novel aspirin-free antiplatelet regimen appears to be associated with a lower bleeding risk than with standard DAPT.

Copyright © 2020 Elsevier Inc. All rights reserved.

Am J Cardiol: 31 Dec 2020; 138:1-10

Relation of Intake of Saturated Fat to Atherosclerotic Risk Factors, Health Behaviors, Coronary Atherosclerosis, and All-Cause Mortality Among Patients Who Underwent Coronary Artery Calcium Scanning.

Rozanski A, Arnson Y, Gransar H, Hayes SW, ... Thomson LEJ, Berman DS

Although very brief questionnaires are commonly used to assess physical activity, an analogous approach for assessing diet quality within clinical practice has not been developed. Thus, we undertook an exploratory study to evaluate the association between a single-item questionnaire regarding dietary quality and patient risk profiles, lifestyle habits, lipid values, coronary artery calcium (CAC) scores and mortality. We assessed 15,368 patients who underwent CAC scanning, followed for a median of 12.1 years for all-cause mortality. Diet quality was assessed according to a single-item question regarding self-reported adherence to a low saturated fat diet (0 = never, 10 = always), with patients categorized into 4 dietary groups based on their response, ranging from low to very high saturated fat intake. We observed a significant stepwise association between reported saturated fat intake and smoking, exercise activity, obesity, and serum cholesterol, low density lipoprotein, and triglyceride values. Following adjustment for age and risk factors, patients reporting very high saturated fat intake had an elevated hazard ratio for mortality versus low saturated fat intake: 1.22 (95% confidence interval 1.04 to 1.44). The hazard ratio was no longer significant after further adjustment for exercise activity. Upon division of patients according to baseline CAC, a stepwise relationship was noted between increasing saturated fat intake and mortality among patients with CAC scores ≥400 (p = 0.002). Thus, within our cohort, just a single-item exploratory questionnaire regarding very high saturated fat intake revealed stepwise associations with health behaviors and cardiac risk factors, suggesting the basis for further development of a practical dietary questionnaire for clinical purposes.

Copyright © 2020 Elsevier Inc. All rights reserved.

Am J Cardiol: 31 Dec 2020; 138:40-45

Relation of Body Mass Index to Outcomes in Acute Coronary Syndrome.

Ratwatte S, Hyun K, D\'Souza M, Barraclough J, ... Brieger D,

We assessed the association of BMI with all-cause and cardiovascular (CV) mortality in a contemporary acute coronary syndrome cohort. Patients from the Australian Cooperative National Registry of Acute Coronary Care, Guideline Adherence and Clinical Events and Global Registry of Acute Coronary Events between 2009 and 2019, were divided into BMI subgroups (underweight: <18.5, healthy: 18.5 to 24.9, overweight: 25 to 29.9, obese: 30 to 39.9, extremely obese: >40). Logistic regression was used to determine the association between BMI group and outcomes of all cause and CV death in hospital, and at 6 months. 8,503 patients were identified, mean age 64 ± 13, 72% male. The BMI breakdown was: underweight- 95, healthy- 2,140, overweight- 3,258, obese- 2,653, extremely obese- 357. Obese patients were younger (66 ± 12 vs 67 ± 13), with more hypertension, diabetes, and dyslipidemia vs healthy (all p < 0.05). Obese had lower hospital mortality than healthy: all-cause: 1% versus 4%, aOR (95% CI): 0.49(0.27, 0.87); CV: 1% versus 3%, 0.51(0.27, 0.96). At 6-month underweight had higher mortality than healthy: all-cause: 11% versus 4%, 2.69(1.26, 5.76); CV: 7% versus 1%, 3.54(1.19, 10.54); whereas obese had lower mortality: all-cause: 1% versus 4%, 0.48(0.29, 0.77); CV: 0.4% versus 1%, 0.42(0.19, 0.93). When BMI was plotted as a continuous variable against outcome a U-shaped relationship was demonstrated, with highest event rates in the most obese (>60). In conclusion, BMI is associated with mortality following an acute coronary syndrome. Obese patients had the best outcomes, suggesting persistence of the obesity paradox. However, there was a threshold effect, and favorable outcomes did not extend to the most obese.

Crown Copyright © 2020. Published by Elsevier Inc. All rights reserved.

Am J Cardiol: 31 Dec 2020; 138:11-19

Usefulness of Coronary Sinus Reducer Implantation for the Treatment of Chronic Refractory Angina Pectoris.

D\'Amico G, Giannini F, Massussi M, Tebaldi M, ... Gaspardone A, Tarantini G

The coronary sinus (CS) Reducer is a novel device designed for the management of patients with severe angina symptoms refractory to optimal medical therapy and not amenable to further revascularization. Aim of this study was to investigate the efficacy and the safety of the CS Reducer device in a real-world, multicenter, and country-level cohort of patients presenting with refractory angina pectoris. The study included patients affected by refractory angina pectoris who underwent CS Reducer implantation in 16 centers. Clinical follow-up was carried as per each center\'s protocol. One hundred eighty-seven patients were included. Technical and procedural success were achieved in 98% and 95%, respectively. Minor peri-procedural complications were recorded in 8 patients. During a median follow-up of 18.4 months, 135 (82.8%) patients demonstrated at least 1 CCS class reduction after Reducer implantation, and 80 (49%) patients at least 2 CCS class reduction. Mean CCS class improved from 3.05 ± 0.53 at baseline to 1.63 ± 0.98 at follow-up (p < 0.001). Treatment benefit was also reflected in a significant improvement in quality of life scores and in a reduction of the mean number of anti-ischemic drugs prescribed for patient. In conclusion, in this multicenter, country-level study, the implantation of CS Reducer in patients with refractory angina pectoris resulted to be safe and effective in reducing of angina pectoris and improving quality of life.

Copyright © 2020 Elsevier Inc. All rights reserved.

Am J Cardiol: 14 Jan 2021; 139:22-27

Efficacy and Safety of Abbreviated Eptifibatide Treatment in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention.

Fischer F, Buxy S, Kurz DJ, Eberli FR, ... Held U, Meyer MR

The glycoprotein IIb/IIIa inhibitor eptifibatide, administered as bolus followed by infusion, is an adjunctive antithrombotic treatment during primary percutaneous coronary intervention (PCI) in selected patients with ST-segment elevation myocardial infarction (STEMI). Whether both bolus and infusion are necessary to improve outcomes is unknown. We hypothesized that primary PCI with eptifibatide bolus only is non-inferior to the conventional treatment (bolus and infusion) with regard to infarct size, while reducing bleeding complications. We analyzed 720 consecutive STEMI patients receiving eptifibatide bolus only or conventional treatment in an observational case-control study utilizing propensity score matching of clinical and intervention-specific confounders. Infarct size was estimated based on myocardial bound creatine kinase, creatine kinase (CK), and CK area under the curve values, with a prespecified non-inferiority margin of 20%. Major bleeding was defined as type 2, 3, or 5 on the Bleeding Academic Research Consortium classification. Eptifibatide bolus only was administered to 147 patients (20%), which were matched 1:1 to patients receiving conventional treatment. Based on peak myocardial bound creatine kinase, CK and CK area under the curve values, infarct size was -8.4% (95% CI [-31.2%, 14.4%]), -11.6% (95% CI [-33.5%, 10.3%]), and -13.9% (95% CI [-34.1%, 6.2%]) after eptifibatide bolus, respectively, reaching prespecified noninferiority compared with conventional treatment. Bolus treatment significantly reduced major bleeding complications (OR 0.48, 95% CI [0.30, 0.79]). In conclusion, eptifibatide given as abbreviated bolus only to selected STEMI patients who underwent primary PCI was noninferior regarding infarct size and resulted in less bleeding complications compared with conventional bolus and infusion treatment.

Copyright © 2020 Elsevier Inc. All rights reserved.

Am J Cardiol: 14 Jan 2021; 139:15-21

Implantable Cardioverter Defibrillator Utilization and Mortality Among Patients ≥65 Years of Age With a Low Ejection Fraction After Coronary Revascularization.

Goldstein SA, Li S, Lu D, Matsouaka RA, ... Wang T, Al-Khatib SM

The purpose of this analysis was to assess implantable cardioverter-defibrillator (ICD) utilization and its association with mortality among patients ≥65 years of age after coronary revascularization. Patients in the National Cardiovascular Database Registry Chest Pain-Myocardial Infarction (MI) Registry who presented with MI from January 2, 2009 to December 31, 2016, had a left ventricular ejection fraction ≤35% and underwent in-hospital revascularization (10,014 percutaneous coronary intervention (PCI) and 1,647 coronary artery bypass grafting (CABG)) were linked with Medicare claims to determine rates of 1-year ICD implantation. The association between ICD implantation and 2-year mortality was assessed. Of 11,661 included patients, an ICD was implanted in 1,234 (10.6%) within 1 year of revascularization (1,063 (10.6%) PCI and 171 (10.4%) CABG). Among PCI-treated patients, in-hospital ventricular arrhythmia (adjusted hazard ratio [aHR] 1.60, 95% confidence interval [CI] 1.34 to 1.92), 2-week cardiology follow-up (aHR 1.48, 95% CI 1.29 to 1.70), readmission for heart failure (aHR 3.21, 95% CI 2.73 to 3.79), and readmission for MI (aHR 2.18, 95% CI 1.66 to 2.85) were positively associated with ICD implantation. Among CABG-treated patients, in-hospital ventricular arrhythmia (aHR 2.33, 95% CI 1.39 to 3.91), and heart failure readmission (aHR 3.14, 95% CI 1.96 to 5.04) were positively associated with ICD implantation. Women were less likely to receive an ICD, regardless of the revascularization strategy. ICD implantation was associated with lower 2-year all-cause mortality (aHR 0.74, 95% CI 0.63 to 0.86). In conclusion, only 1 in 10 Medicare patients with low ejection fraction received an ICD within 1 year after revascularization. Contact with the healthcare system after discharge was associated with higher likelihood of ICD implantation. ICD implantation was associated with lower mortality following revascularization for MI.

Copyright © 2020 Elsevier Inc. All rights reserved.

Am J Cardiol: 31 Dec 2020; 138:26-32

Impact of Chronic Kidney Disease in Patients With Diabetes Mellitus after Percutaneous Coronary Intervention for Left Main Distal Bifurcation (From the Milan and New-Tokyo (MITO) Registry).

Watanabe Y, Mitomo S, Naganuma T, Chieffo A, ... Nakamura S, Colombo A

The impact of chronic kidney disease (CKD) on clinical outcomes after percutaneous coronary intervention for unprotected left main distal bifurcation lesions in patients with diabetes mellitus (DM) is not fully understood in drug eluting stent era. We identified 512 consecutive DM patients who underwent percutaneous coronary intervention for unprotected left main distal bifurcation lesions at New Tokyo Hospital, San Raffaele Scientific Institute and EMO-GVM Centro Cuore Columbus between January 2005 and December 2015. We analyzed according to estimated glomerular filtration rate (eGFR). Each group was defined as follows; no CKD (60 ≤ eGFR), mild CKD (45 ≤ eGFR < 60), moderate CKD (30 ≤ eGFR < 45), and severe CKD (15 ≤ eGFR < 30). The primary end point was target lesion failure (TLF) at 3 years. TLF was defined as a composite of cardiac death, target lesion revascularization, and myocardial infarction. The rate of TLF was significantly higher in the severe CKD group than that in the other groups (Adjusted HR of severe CKD relative to the others 3.64, [1.86 to 7.11], p < 0.001). Cardiac mortality was significantly higher in the severe CKD group than that in the other groups (Adjusted HR of severe CKD relative to the others 6.43, [2.19 to 18.9], p = 0.001). Target lesion revascularization rate was comparable in 4 groups (Adjusted HR of severe CKD relative to the others 1.71, [0.60 to 4.82], p = 0.31). In conclusions, in DM patients, those with severe CKD was extremely associated with worse clinical outcomes.

Copyright © 2020 Elsevier Inc. All rights reserved.

Am J Cardiol: 31 Dec 2020; 138:33-39

Effect of Sex on Outcomes of Coronary Rotational Atherectomy Percutaneous Coronary Intervention (From the European Multicenter Euro4C Registry).

Bouisset F, Ribichini F, Bataille V, Reczuch K, ... Carrié D,

Data regarding the potential influence of sex on outcomes of rotational atherectomy (RA) percutaneous coronary intervention (PCI) are scarce and conflicting. Using the Euro4C registry, an international prospective multicentric registry of RA PCI, we evaluated the influence of sex on clinical outcomes of RA PCI. Between October 2016 and July 2018, 966 patients were included. Among them, 267 (27.6%) were females. Female patients were older than males (77.7 yo +/- 9.8 vs 73.3 +/- 9.5 yo respectively, p<0.001) had a poorer renal function (43,1% of females had a GFR < 60 ml/min:1.73m² vs 30.4% of males, p<0.001) and were more frequently admitted for an acute coronary syndrome (32.2% vs 22.3% p=0.002). During RA procedure, women were less likely to be treated by radial approach (65.0% vs 74.4%, p=0.004). In-hospital major adverse cardiac event (MACE) rate - defined as cardiovascular death, myocardial infarction, stroke/transient ischemic attack, target lesion revascularization and coronary artery bypass grafting surgery - was higher in the female group (7.1% vs 3.7%, p=0.043). However, coronary perforation, dissection, slow/low flow and tamponade did not significantly differ among sex, neither did cardiovascular medications at discharge. At one year follow-up, rate of MACE was 18.4% in the female group vs 11.2% in the male group (adjusted HR 1.82 [1.24 -2.67], p=0.002). No significant bleeding differences were observed among sex, neither in hospital, nor during follow-up. In conclusion women had worse clinical outcomes following RA PCI during hospitalization and at one year follow-up than did men.

Copyright © 2020. Published by Elsevier Inc.

Am J Cardiol: 21 Dec 2020; epub ahead of print

Patient-centered contrast thresholds to reduce acute kidney injury in high-risk patients undergoing percutaneous coronary intervention.

Malik AO, Amin A, Kennedy K, Qintar M, ... Mehran R, Spertus JA
Background
Contrast volume used during percutaneous coronary intervention has a direct relationship with contrast-associated acute kidney injury. While several models estimate the risk of contrast-associated acute kidney injury, only the strategy of limiting contrast volume to 3 × estimated glomerular filtration rate (eGFR) gives actionable estimates of safe contrast volume doses. However, this method does not consider other patient characteristics associated with risk, such as age, diabetes or heart failure.
Methods
Using the National Cardiovascular Data Registry acute kidney injury risk model, we developed a novel strategy to define safe contrast limits by entering a contrast term into the model and using it to meet specific (e.g. 10%) relative risk reductions. We then estimated acute kidney injury rates when our patient-centered model-derived thresholds were and were not exceeded using data from CathPCI version 5 between April 2018 and June 2019. We repeated the same analysis in a sub-set of patients who received ≤ 3 × eGFR contrast.
Results
After excluding patients on hemodialysis, below average risk (<7%), missing data and multiple percutaneous coronary interventions, our final analytical cohort included 141,133 patients at high risk for acute kidney injury. The rate of acute kidney injury was 10.0% when the contrast thresholds derived from our patient-centered model were met and 18.2% when they were exceeded (p<0.001). In patients who received contrast ≤ 3 × eGFR (n=82,318), contrast associated acute kidney injury rate was 9.8% when the contrast thresholds derived from our patient centered model were met and 14.5% when they were exceeded (p <0.001).
Conclusion
A novel strategy for developing personalized contrast volume thresholds, provides actionable information for providers that could decrease rates of contrast associated acute kidney injury. This strategy needs further prospective testing to assess efficacy in improving patient outcomes.

Copyright © 2020 Elsevier Ltd. All rights reserved.

Am Heart J: 22 Dec 2020; epub ahead of print

Usefulness of Coronary Computed Tomographic Angiography to Evaluate Coronary Artery Disease in Radiotherapy-Treated Breast Cancer Survivors.

Tagami T, Almahariq MF, Balanescu DV, Quinn TJ, ... Franklin BA, Bilolikar A

Breast cancer is the most commonly diagnosed cancer in women and radiotherapy is a widely used treatment approach. However, there is an increased risk of coronary artery disease and cardiac death in women treated with radiotherapy. The present study was undertaken to clarify the relationship between radiotherapy and coronary disease in women with previous breast irradiation using coronary computed tomographic angiography (CCTA). We conducted a retrospective analysis of women with a history of right or left-sided breast cancer (RBC; LBC) treated with radiotherapy who subsequently underwent CCTA. RBC patients who had reduced radiation doses to the myocardium served as controls. Patients (n = 6,593) with a history of non-metastatic breast cancer treated with radiotherapy were screened for completion of CCTA; 49 LBC and 45 RBC women were identified. Age and risk factor matched patients with LBC had higher rates of coronary disease compared with RBC patients; left anterior descending (LAD) coronary artery (76% vs 31% [p <0.001]), left circumflex (33% vs. 6.7% [p = 0.004]), and right coronary artery (37% vs 13% [p = 0.018]). Mean LAD radiation dose and mean heart dose strongly correlated with coronary disease, with a 21% higher incidence of disease in the LAD per Gy for mean LAD dose and a 95% higher incidence of disease in the LAD per Gy for mean heart dose. In conclusion, LBC patients treated with radiotherapy have a significantly higher incidence of coronary disease when compared to a matched group of patients treated for RBC. Radiation doses correlated with the incidence of coronary disease.

Copyright © 2020. Published by Elsevier Inc.

Am J Cardiol: 21 Dec 2020; epub ahead of print

Long-Term Durability of Transcatheter Aortic Valve Implantation With Self-Expandable Valve System (From a Real-World Registry).

Carrabba N, Migliorini A, Fumagalli C, Taborchi G, ... Marchionni N, Valenti R

As transcatheter aortic valve Implantation (TAVI) moves to younger and lower risk patients with longer life expectancy, the long-term durability of TAVI is becoming an increasingly relevant issue. We sought to evaluate the long-term clinical outcome and prosthesis performance of the CoreValve self-expandable valve. Clinical registry of 182 patients consecutively treated with TAVI in a tertiary center from January 2009 to July 2017. Of these, 111 died during an average follow-up (FU) of 1,026±812 days (median IQR: 745, 477-1,400 days; longest survival 11 years; 61% mortality at Kaplan-Meier analysis). At 1 month, functional profile improved in all survivors, with 93.9% of them achieving NYHA class I or II. At Cox analysis, the Society of Thoracic Surgeons score (HR: 1.55; p=0.001), left ventricular ejection fraction <40% (HR: 1.65; p=0.017) and incident acute kidney injury (HR: 1.96; p=0.001) were independently associated with all-cause mortality. During FU, echocardiographically assessed mean transprosthetic aortic gradient remained substantially unchanged (from 9.0±2.7 post TAVI to 9.0±5.0 mmHg at FU; p>0.05). Most patients had none/trivial (34%) or mild (58%), fewer had moderate (8%) and none had severe perivalvular leak, without significant change during FU. At 11 years, cumulative incidence of bioprosthetic valve failure (BVF) and moderate structural valve deterioration (SVD) were 2.9% (95% CI 0.8-10%) and 9.3% (95% CI 3.3-26.7%), respectively. In conclusion, our registry confirmed that TAVI with the self-expandable CoreValve system was associated with favorable long-term clinical outcomes, with a reassuring low rate of significant BVF and moderate SVD.

Copyright © 2020. Published by Elsevier Inc.

Am J Cardiol: 21 Dec 2020; epub ahead of print

Outpatient Versus Inpatient Percutaneous Coronary Intervention in Patients with Left Main Disease (From the EXCEL Trial).

Gaba P, Serruys PW, Karmpaliotis D, Lembo NJ, ... Kappetein AP, Stone GW

Prior studies in patients with non-complex coronary artery disease (CAD) have demonstrated the safety of percutaneous coronary intervention (PCI) in the outpatient setting. We sought to examine the outcomes of outpatient PCI in patients with unprotected left main CAD (LMCAD). In the EXCEL trial, 1905 patients with LMCAD and site-assessed low or intermediate SYNTAX scores were randomized to PCI with everolimus-eluting stents versus coronary artery bypass grafting. The primary endpoint was major adverse cardiovascular events (MACE; the composite of death, stroke, or MI). In this sub-analysis, outcomes at 30 days and 5 years were analyzed according to whether PCI was performed in the outpatient versus inpatient setting. Among 948 patients with LMCAD assigned to PCI, 935 patients underwent PCI as their first procedure, including 100 (10.7%) performed in the outpatient setting. Patients who underwent outpatient compared with inpatient PCI were less likely to have experienced recent MI. Distal LM bifurcation disease involvement and SYNTAX scores were similar between the groups. Comparing outpatient to inpatient PCI, there were no significant differences in MACE at 30 days (4.0% versus 5.0% respectively, adjusted OR 0.52 95% CI 0.12-2.22; p=0.38) or 5 years (20.6% versus 22.1% respectively, adjusted OR 0.72, 95% CI 0.40-1.29; p=0.27). Similar results were observed in patients with distal LM bifurcation lesions. In conclusion, in the EXCEL trial, outpatient PCI of patients with LMCAD was not associated with an excess early or late hazard of MACE. These data suggest that outpatient PCI may be safely performed in select patients with LMCAD.

Copyright © 2020. Published by Elsevier Inc.

Am J Cardiol: 21 Dec 2020; epub ahead of print

Outcome of Patients with Severe Aortic Stenosis and Normal Coronary Arteries Undergoing Transcatheter Aortic Valve Implantation.

Kuzo N, Stähli BE, Erhart L, Anwer S, ... Ruschitzka F, Tanner FC

Coronary artery disease and severe aortic stenosis (AS) often coexist. This study sought to investigate the impact of normal coronary arteries as negative risk marker in patients undergoing transcatheter aortic valve implantation (TAVI). Consecutive patients with severe AS undergoing TAVI were dichotomized according to the presence or absence of normal coronary arteries, defined as absence of coronary lesions with diameter stenosis ≥30% in vessels ≥1.5 mm in diameter on coronary angiogram in patients without prior coronary revascularization. The primary endpoint was 1-year mortality. Out of 987 patients with severe AS undergoing TAVI, 258 (26%) patients had normal coronary arteries. These patients were younger, more likely women, and had lower EuroSCORE II and STS risk scores. While mortality at 30 days was similar in the normal coronary artery and the coronary atherosclerosis groups (3.1% versus 5.6%, p=0.11), it was lower in those with normal coronary arteries at 1 year (8.9% versus 17%, p=0.003). In multivariable analysis, the presence of normal coronary arteries on coronary angiogram independently predicted 1-year mortality (adjusted HR 0.57, 95% CI 0.37-0.90, p=0.02). In conclusion, this study defined normal coronary arteries as negative risk marker in patients with severe AS undergoing TAVI.

Copyright © 2020. Published by Elsevier Inc.

Am J Cardiol: 20 Dec 2020; epub ahead of print

Trends and Predictors of Transcatheter Aortic Valve Implantation Related In-Hospital Mortality (From a National Inpatient Sample Database).

Ullah W, Zahid S, Hamzeh I, Birnbaum Y, Virani SS, Alam M

Existing surgical aortic valve replacement (SAVR) risk models accurately predict the post-SAVR morbidity and mortality, but factors associated with post transcatheter aortic valve Implantation (TAVI) mortality are not well known. The National Inpatient Sample (NIS) was queried to identify all cases of TAVI. The association of baseline comorbidities with in-hospital mortality was determined using a binary logistic regression model to obtain adjusted odds ratios (aOR). A total of 161,049 patients underwent TAVI between 2010 and 2017. Of these, 157,151 (97.6%) survived while 3,898 (2.4%) died during hospitalization. The baseline characteristics of TAVI-survivors and non-survivors showed a significant amount of variation, including age (80 vs. 82 years, p=<0.0001) and female sex (46% vs. 52%, p=<0.0001), respectively. The non-survivors had significantly higher adjusted odds of renal failure requiring hemodialysis (aOR 2.59, 95% CI 2.24-2.99, p=<0.0001), history of mediastinal radiation (aOR 2.71, 95% CI 1.02-7.20, p=0.05), liver disease (aOR 3.04, 95% CI 2.63-3.51, p=<0.0001), pneumonia (aOR 2.47, 95% CI 2.15-2.83, p=<0.0001), cardiogenic shock (aOR 9.83, 95% CI 8.93-10.82, p=<0.0001), ventricular tachycardia (aOR 2.12, 95% CI 1.88-2.40, p=<0.0001), acute ST-elevation myocardial infarction (STEMI) (aOR 7.38, 95% CI 5.53-9.84, p=<0.0001), stroke (aOR 2.25, 95% CI 1.99-2.54, p=<0.0001), and acute infective endocarditis (aOR 5.74, 95% CI 3.65-9.02, p=<0.0001) compared to TAVI-survivors. The yearly trend of mortality showed an increase in the absolute number of TAVI procedures and mortality but the yearly rate showed a decline in mortality after an initial peak during 2012.Patients with renal failure on dialysis, STEMI, cardiogenic shock, infective endocarditis, liver disease and pneumonia have a higher rate of in-hospital mortality post TAVI.

Copyright © 2020. Published by Elsevier Inc.

Am J Cardiol: 20 Dec 2020; epub ahead of print

Comparison of Outcomes of Beta-Blocker Therapy after Acute Myocardial Infarction in Patients without Heart Failure or Left Ventricular Systolic Dysfunction (From the Acute Coronary Syndromes Israeli Survey [ACSIS]).

El Nasasra A, Beigel R, Klempfner R, Alnsasra H, ... Blatt A, Zahger D

The contemporary benefit of routine beta-blocker therapy following myocardial infraction in the absence of heart failure or left ventricular systolic dysfunction (LVSD) is unclear. We investigated the impact of beta-blockers on post myocardial infarction outcome in patients without heart failure or LVSD among patients enrolled in the biennial Acute Coronary Syndrome Israeli Surveys (ACSIS). MACE rates at 30 days and overall mortality at one year were compared among patients discharged on beta-blockers vs. not, after multivariate analysis to adjust for baseline differences. Between the years 2000-2016, data from 15.211consecutive ACS patients were collected. Of 7392 patients who met the inclusion criteria, 6007 (79.9%) were discharged on beta-blocker therapy. Prescription of beta-blockers at discharge increased modestly from 32% to 38% over the 16-year period. The 30-day MACE rates were similar in patients on vs. not on beta-blockers at discharge (9.0% and 9.5%, respectively). One year survival did not differ significantly between those on vs. not on beta-blockers (HR 0.8, 95% CI 0.58-1.11, P= 0.18).In conclusion, beta-blocker therapy did not affect 30 days MACE or one-year survival after myocardial infarction in patients without heart failure or reduced ejection fraction.

Copyright © 2020. Published by Elsevier Inc.

Am J Cardiol: 20 Dec 2020; epub ahead of print

Randomized evaluation of beta blocker and ACE-inhibitor/angiotensin receptor blocker treatment in patients with myocardial infarction with non-obstructive coronary arteries (MINOCA-BAT): Rationale and design.

Nordenskjöld AM, Agewall S, Atar D, Baron T, ... Tornvall P, Lindahl B

Myocardial infarction with non-obstructive coronary arteries (MINOCA) is common and occurs in 6-8% of all patients fulfilling the diagnostic criteria for acute myocardial infarction (AMI). This paper describes the rationale behind the trial \'Randomized Evaluation of Beta Blocker and ACE-Inhibitor/Angiotensin Receptor Blocker Treatment (ACEI/ARB) of MINOCA patients\' (MINOCA-BAT) and the need to improve the secondary preventive treatment of MINOCA patients.
Methods:
MINOCA-BAT is a registry-based, randomized, parallel, open-label, multicenter trial with 2:2 factorial design. The primary aim is to determine whether oral beta blockade compared with no oral beta blockade, and ACEI/ARB compared with no ACEI/ARB, reduce the composite endpoint of death of any cause, readmission because of AMI, ischemic stroke or heart failure in patients discharged after MINOCA without clinical signs of heart failure and with left ventricular ejection fraction ≥40%. A total of 3500 patients will be randomized into four groups; e.g. ACEI/ARB and beta blocker, beta blocker only, ACEI/ARB only and neither ACEI/ARB nor beta blocker, and followed for a mean of 4 years. SUMMARY: While patients with MINOCA have an increased risk of serious cardiovascular events and death, whether conventional secondary preventive therapies are beneficial has not been assessed in randomized trials. There is a limited basis for guideline recommendations in MINOCA. Furthermore, studies of routine clinical practice suggest that use of secondary prevention therapies in MINOCA varies considerably. Thus results from this trial may influence future treatment strategies and guidelines specific to MINOCA patients.

Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.

Am Heart J: 30 Dec 2020; 231:96-104

High levels of eicosapentaenoic acid are associated with lower pericoronary adipose tissue attenuation as measured by coronary CTA.

Bittner DO, Goeller M, Dey D, Zopf Y, Achenbach S, Marwan M
Background:
and aims
Higher pericoronary adipose tissue (PCAT) attenuation, a novel marker of inflammation in coronary CT angiography (CTA), has been shown to indicate increased cardiac mortality. Supplementation of eicosapentaenoic acid (EPA) has been shown to decrease cardiovascular death. Whether blood levels of n-3 fatty acids are associated with differences in PCAT attenuation is unknown.
Methods
This is a cross-sectional analysis including 64 symptomatic patients who underwent coronary CTA. PCAT attenuation was measured in Hounsfield Units (HU) around the proximal 40 mm of the right coronary artery using semi-automated software. Erythrocyte membrane fatty acid composition was analyzed using gas chromatography. Individual fatty acids were expressed as a percentage of total identified fatty acids.
Results
The patient cohort was divided into two groups using the median PCAT attenuation of -78.1 HU (each n = 32). No differences were seen in age, sex, BMI or traditional cardiovascular risk factors (CVRF) between groups (all p > 0.05). In univariable analysis, significantly higher values of EPA (1.00% [0.78; 1.26] vs. 0.78% [0.63; 0.99]; p = 0.02) were seen in patients with lower PCAT attenuation. All other fatty acids showed no differences (all p > 0.05). Moreover, a significant negative correlation was seen between PCAT attenuation and EPA (CC: 0.38; p = 0.002). In multivariable analysis, an inverse association of EPA with PCAT attenuation existed (ß = -0.31, p = 0.017), independent of age, gender, BMI and number of CVRF (all p > 0.1).
Conclusions
High levels of EPA are associated with lower PCAT attenuation on coronary CTA. This may indicate a different composition of pericoronary adipose tissue, potentially caused by a lower degree of coronary inflammation.

Copyright © 2020 Elsevier B.V. All rights reserved.

Atherosclerosis: 30 Dec 2020; 316:73-78

Comparison of Characteristics and Outcomes of Patients with Acute Myocardial Infarction with versus without Coronarvirus-19.

Case BC, Yerasi C, Forrestal BJ, Shea C, ... Rogers T, Waksman R

The coronavirus disease 2019 (COVID-19) pandemic has greatly impacted the US healthcare system. Cardiac involvement in COVID-19 is common and manifested by troponin and natriuretic peptide elevation and tends to have a worse prognosis. We analyzed patients who presented to the MedStar Health system (11 hospitals in Washington, DC, and Maryland) with either an ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI) early in the pandemic (March 1, 2020 - June 30, 2020) using the International Classification of Diseases, Tenth Revision. Patients\' clinical course and outcomes, including in-hospital mortality, were compared on the basis of the results of COVID-19 status (positive or negative). The cohort included 1533 patients admitted with an acute myocardial infarction (AMI), of whom 86 had confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, during the study period. COVID-19-positive patients were older and non-White and had more co-morbidities. Furthermore, inflammatory markers and N-terminal-proB-type-natriuretic peptide were higher in COVID-19-positive AMI patients. Only 20.0% (17) of COVID-19-positive patients underwent coronary angiography. In-hospital mortality was significantly higher in AMI patients with concomitant COVID-19-positive status (27.9%) than in patients without COVID-19 during the same period (3.7%; p<0.001). Patients with AMI and COVID-19 tended to be older, with more co-morbidities, when compared to those with an AMI and without COVID-19. In conclusion, myocardial infarction with concomitant COVID-19 was associated with increased in-hospital mortality. Efforts should be focused on the early recognition, evaluation, and treatment of these patients.

Copyright © 2020. Published by Elsevier Inc.

Am J Cardiol: 28 Dec 2020; epub ahead of print

Prevalence and Determinants of Atrial Fibrillation-associated In-hospital Ischemic Stroke in patients with Acute Myocardial Infarction undergoing Percutaneous Coronary Intervention.

Patil S, Gonuguntla K, Rojulpote C, Kumar M, ... Nardino RJ, Pickett C

Atrial Fibrillation (AF) is an established risk factor ischemic stroke (IS) and is commonly encountered in patient hospitalized with acute myocardial infarction (AMI). Uncommonly, IS can occur as a complication resulting from percutaneous coronary intervention (PCI). There is limited real world data regarding AF-associated in-hospital IS (IH-IS) in patients admitted with AMI undergoing PCI. We queried the National Inpatient Sample database from January 2010 to December 2014 to identify patients admitted with AMI who underwent PCI. In this cohort, we determined the prevalence of AF associated IH- IS and compared risk factors for IH-IS between patients with AF and without AF using multivariable logistic regression models. IH-IS was present in 0.46% (n= 5,938) of the patients with AMI undergoing PCI (n= 1,282,829). Prevalence of IH-IS in patients with AF was higher compared to patients without AF (1.05% vs.0.4%; aOR: 1.634, 95% CI: 1.527 -1.748, p< 0.001). Regardless of AF status, prevalence and risk of IH-IS was higher in females and increased with advancing age. There was significant overlap among risk-factors associated with increased risk of IH-IS in AF and non-AF cohorts, except for obesity in AF patients (aOR: 1.268, 95% CI: 1.023- 1.572, p=0.03) in contrast to renal disease, malignancy and peripheral vascular disease in non-AF patients. In conclusion, IH-IS is a rare complication affecting patients undergoing PCI for AMI and is more likely to occur in AF patients, females, and older adults, with heterogeneity among risk factors in patients with and without AF.

Copyright © 2020. Published by Elsevier Inc.

Am J Cardiol: 28 Dec 2020; epub ahead of print

Trends, Outcomes and Predictive Score For Emergency Coronary Artery Bypass Graft Surgery After Elective Percutaneous Coronary Intervention (From a Nationwide Dataset).

Pancholy SB, Patel GA, Patel NR, Patel DD, ... Mamas MA, Patel TM

The temporal trends and preprocedural predictors of emergency coronary artery bypass graft surgery (ECABG) after elective percutaneous coronary intervention (PCI) in the contemporary era are largely unknown. From January 2003 to December 2014 elective hospitalizations with PCI as the primary procedure were extracted from the Nationwide Inpatient Sample. ECABG was identified as CABG within 24 hours of elective PCI. Temporal trends of elective PCI, ECABG, comorbidities, and in-hospital mortality were analyzed. Logistic regression model was used to identify preprocedural independent predictors of ECABG and post-PCI ECABG risk score was developed using the regression coefficients from the logistic regression model in the development cohort. The score was then validated in the validation cohort. Of 1,605,641 elective PCI procedures included in the final analysis, 5,561 (0.3%) patients underwent ECABG. The incidence of ECABG, comorbidities and overall in-hospital mortality increased over the study period, whereas the in-hospital mortality after ECABG remained unchanged. An increasing trend of elective PCI performed at facilities without on-site CABG was noted, with a higher unadjusted in-hospital mortality in this cohort. ECABG risk score, performed well with a significantly higher risk of ECABG in those patients with a score in the highest tertile compared to those with lower ECABG score (0.6% vs 0.3%, P = 0.0005). In conclusion, an increasing trend of adverse outcomes after elective PCI is observed. We describe an easy-to-use predictive score using pre-procedural variables that may allow the operator to triage the patient to an appropriate setting in an effort to improve outcomes.

Copyright © 2020. Published by Elsevier Inc.

Am J Cardiol: 28 Dec 2020; epub ahead of print

Incidence, Management, Immediate and Long-Term Outcome of Guidewire and Device Related Grade III Coronary Perforations (From G3CAP - Cardiogroup VI registry).

Cerrato E, Pavani M, Barbero U, Colombo F, ... Varbella F,

Ellis grade III coronary artery perforations (G3-CAP) remain a life-threatening complication of PCI, with high morbidity and mortality and lack of consensus regarding optimal treatment strategies. We reviewed all PCIs performed in 10 European centers from 1993 to 2019 recording all G3CAP along with management strategies, in-hospital and long-term outcome according to Device-related (DP) and Guidewire-related (WP) perforations. Among 106,592 PCI (including 7,773 chronic total occlusions (CTO)), G3-CAP occurred in 311 patients (0.29%). DP occurred in 194 cases (62.4%), more commonly in proximal segments (73.2%) and frequently secondary to balloon dilatation (66.0%). WP arose in 117 patients (37.6%) with CTO guidewires involved in 61.3% of cases. Overall sealing success rate was 90.7% and usually required multiple maneuvers (80.4%). The most commonly adopted strategies to obtain haemostasis were prolonged balloon inflation (73.2%) with covered stent implantation (64.4%) in the DP group, and prolonged balloon inflation (53.8%) with coil embolization (41%) in the WP group.  Procedural or in-hospital events arose in 38.2% of cases: mortality was higher after DP (7.2% vs 2.6%, p=0.05) and acute stent thrombosis 3-fold higher (3.1% vs 0.9%, p=0.19). At clinical follow-up, median two years, a major cardiovascular event occurred in one-third of cases (all-cause mortality 8.2% and 7.1% respectively, without differences between groups). In conclusion, although rare and despite improved rates of adequate perforation sealing G3-CAP cause significant adverse events. DP and WP result in different patterns of G3-CAP and management strategies should be based on this classification.

Copyright © 2020. Published by Elsevier Inc.

Am J Cardiol: 29 Dec 2020; epub ahead of print

Short-Term Outcomes of Transcatheter Aortic Valve Implantation versus Surgical Aortic Valve Replacement in Kidney Transplant Recipients (From the US Nationwide Representative Study).

Abdelfattah OM, Saad AM, Aboshouk A, Hassanein M, ... Krishnaswamy A, Kapadia S

Kidney transplant recipients (KTRs) are considered high-risk patients for surgical interventions. Transcatheter aortic valve implantation (TAVI) has been introduced as an alternative to surgical aortic valve replacement (SAVR) in patients with aortic stenosis (AS) at high operative risk. However, the outcomes of TAVI compared to SAVR KTRs have not been well-studied in nationally representative data. Patients with prior history of functioning kidney transplant who were hospitalized for TAVI and SAVR between January 2012 and December 2017 were identified retrospectively in the Nationwide Readmissions Database. Our study included 762 TAVI and 1,278 SAVR KTRs. Compared to SAVR, TAVI patients generally had higher rates of comorbidities with lower risk of in-hospital mortality (3.1% vs. 6.3, P=0.002), blood transfusion (11.5% vs. 38.6%, P<0.001), acute myocardial infarction (3.9% vs. 6.5%, P=0.16), acute kidney injury (24.5% vs. 42.1%, P<0.001), sepsis (3.9% vs. 9.5%, P<0.001) and discharge with disability (42.6% vs. 68.4%, P<0.001). However, the rate of permanent pacemaker implantation was significantly higher in TAVI group (11.4% vs. 3.9%, P<0.001). Of note, in-hospital stroke and 30-day readmission were comparable between both groups. These findings were confirmed after adjusting for other comorbidities. TAVI is growing as a valid and safe alternative for KTRs with severe AS.

Copyright © 2020. Published by Elsevier Inc.

Am J Cardiol: 27 Dec 2020; epub ahead of print

Effect of Losartan or Atenolol on Children and Young Adults with Bicuspid Aortic Valve and Dilated Aorta.

Flyer APOPJN, Sleeper APOPLA, Colan POPSD, Singh APOPMN, Lacro APOPRV

Bicuspid aortic valve (BAV) aortopathy is defined by dilation of the aortic root (AoRt) and/or ascending aorta (AsAo), and increases risk for aortic aneurysm and dissection. The effects of medical prophylaxis on aortic growth rates in moderate to severe bicuspid aortopathy have not yet been evaluated. This was a single-center retrospective study of young patients (1 day - 29 years) with bicuspid aortopathy (AoRt or AsAo z-score ≥ 4 SD, or absolute dimension ≥ 4 cm), treated with either losartan or atenolol. Maximal diameters and BSA-adjusted z-scores obtained from serial echocardiograms were utilized in a mixed linear effects regression model. The primary outcome was the annual rate of change in AoRt and AsAo z-scores during treatment, compared with before treatment. The mean ages (years) at treatment initiation were 14.2±5.1 (losartan; n = 27) and 15.2±4.9 (atenolol; n = 18). Median treatment duration (years) was 3.1 (IQR 2.4, 6.0) for losartan, and 3.7 (IQR 1.4, 6.6) for atenolol. Treatment was associated with decreases in AoRt and AsAo z-scores (SD/year), for both losartan and atenolol (pre- vs. post-treatment): losartan/AoRt: +0.06±0.02 vs. -0.14±0.03, p < 0.001; losartan/AsAo: +0.20±0.03 vs. -0.09±0.05, p < 0.001; atenolol/AoRt: +0.07±0.03 vs. -0.02±0.04, p = 0.04; atenolol/AsAo: +0.21±0.04 vs. -0.06±0.06, p < 0.001. Treatment was also associated with decreases in absolute growth rates (cm/year) for all comparisons (p ≤ 0.02). Medical prophylaxis reduced proximal aortic growth rates in young patients with at least moderate and progressive bicuspid aortopathy.

Copyright © 2020. Published by Elsevier Inc.

Am J Cardiol: 27 Dec 2020; epub ahead of print

Assessing the Best Prognostic Score for Transcatheter Aortic Valve Implantation (From the RISPEVA Registry).

Pepe M, Corcione N, Petronio AS, Berti S, ... Biondi-Zoccai G, Giordano A

The ACC/TVT score is a specific predictive model of in-hospital mortality for patients undergoing transcatheter aortic valve implantation (TAVI). The aim of this study was to test its predictive accuracy in comparison with standard surgical risk models (Logistic Euroscore, Euroscore II, and STS-PROM) in the population of TAVI patients included in the multicenter RISPEVA (Registro Italiano GISE sull\'impianto di Valvola Aortica Percutanea) registry. The study cohort included 3293 patients who underwent TAVI between 2008 and 2019. The four risk scores were calculated for all patients. For all scores, the capability to predict 30-day mortality was assessed by means of several analyses testing calibration and discrimination. The ACC/TVT score showed moderate discrimination, with a C-statistics for 30-day mortality of 0.63, not significantly different from the standard surgical risk models. The ACC/TVT score demonstrated, on the other hand, better calibration compared to the other scores, as proved by a greater correspondence between estimated probabilities and the actual observations. However, when the ACC/TVT score was tested in the subgroup of patients treated in a more contemporary period (from 2016 on), it revealed a slight tendency to lose discrimination and to overestimate mortality risk. In conclusion, in comparison with the standard surgical risk models, the ACC/TVT score demonstrated a better prediction accuracy for estimation of 30-day mortality in terms of calibration. Nevertheless, its predictive reliability remained suboptimal and tended to worsen in patients treated more recently.

Copyright © 2020. Published by Elsevier Inc.

Am J Cardiol: 27 Dec 2020; epub ahead of print

Transcatheter Aortic Valve Implantation for Failed Surgical Aortic Bioprostheses using a Self-Expanding Device (From the Prospective VIVA Post Market Study).

Kornowski R, Chevalier B, Verhoye JP, Holzhey D, ... Tchétché D,

Patients with symptomatic aortic stenosis are often treated with a surgical valve replacement. Surgical bioprosthetic valves degenerate overtime and therefore may require a redo surgery. This analysis reports the 2-year clinical outcomes of the Valve-in-Valve (VIVA) study which evaluated transcatheter aortic valve implantation (TAVI) using the CoreValve and Evolut R devices in patients with degenerated surgical aortic bioprostheses at high risk for surgery. The prospective VIVA study enrolled 202 eligible patients with failing surgical aortic bioprostheses due to stenosis, regurgitation or a combination of both. The Evolut R bioprosthesis was used in 90.5% of valve-in-valve (ViV) TAVI cases. 2-year all-cause and cardiovascular mortality rates were 16.5% and 11.1%, respectively. Other clinical events included stroke (7.9%), disabling stroke (1.7%), and new pacemaker implantation (10.1%). The 2-year all-cause mortality was significantly higher in patients with discharge mean gradients ≥20 mmHg vs. those with lower mean gradients (21.0% vs. 7.6%, p = 0.025). Discharge mean gradients ≥20 mmHg were associated with smaller surgical bioprostheses (OR, 7.2 [95% CI 2.3-22.1]. In patients with failing surgical aortic bioprostheses, ViV treatment using a supra-annular self-expanding bioprosthesis provides significant functional improvements with acceptable rates of complications, especially if a postprocedural mean gradient of <20 mmHg can be achieved.

Copyright © 2020. Published by Elsevier Inc.

Am J Cardiol: 27 Dec 2020; epub ahead of print

Transcatheter Aortic Valve Implantation in Patients with Severe Aortic Stenosis Hospitalized with Acute Heart Failure.

Kaewkes D, Ochiai T, Flint N, Patel V, ... Cheng W, Makkar R

Optimal timing and outcomes of transcatheter aortic valve implantation (TAVI) in patients presenting with acute heart failure (AHF) remain unclear. In this consecutive cohort of 1547 patients with severe aortic stenosis undergoing TAVI, the AHF status at admission was collected, and patients were classified into AHF and elective TAVI groups. In the AHF group, early TAVI was defined as TAVI performed ≤60 hours after emergency room arrival. The primary outcome was all-cause mortality at 30-day and 2-year after TAVI. There were 139 (9%) patients who underwent TAVI while hospitalized with AHF. At baseline, this group had higher rates of chronic kidney disease, higher Society of Thoracic Surgeons score, and lower left ventricular ejection fraction. After adjusting for baseline differences, the AHF group had significantly higher all-cause mortality at 30-day and 2-year than the elective TAVI group (8% vs. 2%; p=0.002, and 33% vs. 18%; p=0.002, respectively). In the AHF group, 43 (31%) patients underwent early treatment with TAVI. No significant difference in all-cause mortality at 30-day was observed between early and non-early TAVI groups (5% vs. 10%; p=0.617). All-cause mortality at 2-year was lower in the early TAVI groups (16% vs. 40%, log-rank p=0.022); however, after multivariable adjustment, the difference was barely statistically significant (p=0.053). In conclusion, TAVI in patients with AHF was associated with worse short and long-term outcomes. In AHF setting, early TAVI did not significantly reduce all-cause mortality at 30-day; however, it showed a strong trend for lower all-cause mortality at 2-year.

Copyright © 2020. Published by Elsevier Inc.

Am J Cardiol: 27 Dec 2020; epub ahead of print

Incidence, Predictors and Outcome of In-Hospital Bleeding in Patients With Cardiogenic Shock Complicating Acute Myocardial Infarction.

Ratcovich H, Josiassen J, Helgestad OKL, Linde L, ... Møller JE, Holmvang L

Bleeding after acute myocardial infarction (AMI) is associated with an increased morbidity and mortality. The frequency and consequences of bleeding events in patients with AMICS are not well described. The objective was to investigate incidence and outcome of bleeding complications among unselected patients with AMI complicated by cardiogenic shock (AMICS) and referred for immediate revascularization. Bleeding events were assessed by review of medical records in consecutive AMICS patients admitted between 2010 and 2017. Bleedings during admission were classified according to Bleeding Academic Research Consortium (BARC) classification. Patients who did not survive to admission in the intensive care unit (ICU) were excluded. Of the 1716 patients admitted with AMICS, 1532 patients (89%) survived to ICU admission. At 30 days, mortality was 48%. Severe bleedings classified as BARC 3/5 were seen in 87 non-CABG patients (6.1%). Comorbidity did not differ among patients, however patients who had a BARC 3/5 bleeding had significantly higher lactate and lower systolic blood pressure at admission, indicating a more severe state of shock. The use of mechanical assist devices was significantly associated with severe bleeding events. Univariable analysis showed that patients with a BARC 3/5 bleeding had a significantly higher 30-day mortality hazard compared to patients without severe bleedings. The association did not sustain after multivariable adjustment (HR 0.90, 95% CI 0.64;1.26, p=0.52). In conclusion, severe bleeding events according to BARC classification in an all-comer population of patients with AMICS, were not associated with higher mortality when adjusting for immediate management, hemodynamic and metabolic state. This indicates that mortality in these patients is primarily related to other factors.

Copyright © 2020. Published by Elsevier Inc.

Am J Cardiol: 27 Dec 2020; epub ahead of print

Rate of Incomplete Revascularization Following Coronary Artery Bypass Grafting at a Single Institution Between 2007 and 2017.

Soukup CR, Schmidt CW, Chan-Tram C, Garberich RF, Sun BC, Traverse JH

Incomplete revascularization following coronary artery bypass grafting (CABG) is associated with increased repeat revascularization, myocardial infarction and death. Whether the rate of incomplete revascularization is increasing over time has not been previously described. All patients with multivessel coronary artery disease who underwent isolated and elective CABG at our Institution in 2007 (n=291) were compared to patients who underwent CABG in 2017 (n=290). A Revascularization Index Score was created to compare rates of incomplete revascularization between the 2 years based on the coronary anatomy and degree of stenosis. Comparison of the 2 years disclose that the rate of incomplete revascularization increased from 17.9% in 2007 to 28.3% in 2017 (p = 0.003) and was accompanied by a decline in the Revascularization Index Score from 0.73 to 0.67 (p= 0.005). Left ventricular function improved in both groups following CABG. Two-year cardiovascular mortality was significantly higher in the 2017 cohort compared to the 2007 cohort. These differences may be attributable to patient factors including more severe coronary artery disease associated with older age, greater incidence of smoking and previous percutaneous coronary intervention. In conclusion, the rate of incomplete revascularization following CABG significantly increased in 2017 compared to 2007 and was associated with higher cardiovascular mortality.

Copyright © 2020. Published by Elsevier Inc.

Am J Cardiol: 27 Dec 2020; epub ahead of print

nPrognostic Value and Interplay between Myocardial Tissue Velocities in Patients Undergoing Coronary Artery Bypass Grafting.

Olsen FJ, Lindberg S, Fritz-Hansen T, Modin D, ... Møgelvang R, Biering-Sørensen T

Early diastolic tissue velocity (e\') by tissue Doppler imaging (TDI) represents an early marker of left ventricular (LV) dysfunction in ischemic heart disease. We assessed the value of e\' for predicting mortality in patients undergoing coronary artery bypass grafting (CABG). We retrospectively investigated patients treated with CABG between 2006-2011. Before surgery, all patients underwent an echocardiogram with TDI to measure tissue velocities: systolic (s\'), e\', and late diastolic (a\'). The primary outcome was all-cause mortality. Survival analysis was applied. Improvement of EuroSCORE-II was assessed by net reclassification index. Of 660 patients, 72 (11%) died during a median follow-up time of 3.8 years. Mean age was 68 years, LVEF 50%, and 84% were men. All tissue velocities showed a significant negative association with outcome and e\' provided highest Harrell\'s C-statistics (c-stat=0.68). After multivariable adjustment for EuroSCORE-II, LV hypertrophy, LV internal diameter, and global longitudinal strain, declining e\' was associated with a higher risk of mortality (HR=1.35 (1.12-1.61), p=0.001, per 1cm/s absolute decrease). LVEF≤40% modified the relationship between both s\' and e\' and outcome (p for interaction=0.021 and 0.024, respectively), such that neither predicted mortality when LVEF was ≤40%. In patients with LVEF>40%, only e\' remained a predictor after multivariable adjustments (HR=1.36 (1.10-1.69), p=0.005, per 1cm/s absolute decrease). A net reclassification index improvement of 14% was observed when adding global e\' to the EuroSCORE-II. In conclusion, e\' is an independent predictor of all-cause mortality in patients undergoing CABG, especially in patients with LVEF>40%, and improves the predictive value of EuroSCORE-II.

Copyright © 2020. Published by Elsevier Inc.

Am J Cardiol: 27 Dec 2020; epub ahead of print

Coronary plaque burden, plaque characterization and their prognostic implications in familial hypercholesterolemia: A computed tomographic angiography study.

Pérez de Isla L, Alonso R, Gómez de Diego JJ, Muñiz-Grijalvo O, ... Mata P,
Background:
and aims
Heterozygous familial hypercholesterolemia (FH) is associated with premature atherosclerotic cardiovascular disease. Semi-automated plaque characterization (SAPC) by coronary computed tomographic angiography (CTA) provides information regarding coronary plaque burden and plaque characterization. Our aim was to quantify and characterize the coronary plaque burden of patients with FH using SAPC analysis and to identify which factors are related to plaque burden and plaque characteristics. A second aim was to analyse the prognostic implications of these parameters.
Methods
Two hundred and fifty-nine asymptomatic individuals with molecularly determined FH were enrolled in this follow-up cohort study and underwent a coronary CTA analysed with SAPC.
Results
Mean follow-up time after coronary CTA was 3.9 ± 2 years. Mean age was 46.9 (10.7) years (130 women, 50.2%). Median plaque burden was 25.0% (19.0-29.0), non-calcified plaque burden 22.83% (17.94-26.88), calcified plaque-burden 1.12% (0.31-2.86) and CCS 8.9 (0-93). Five-year risk was independently related to plaque burden, non-calcified plaque burden, calcified plaque burden and coronary calcium score (B:3.75, 95%CI:2.92-4.58; p < 0.001, B:2.9, 95%CI:2.15-3.66; p < 0.001, B:0.75, 95%CI 0.4-1.1; p < 0.001 and B:82.2, 95%CI:49.28-115.16; p < 0.001 respectively). During follow-up, there were 15 (5.81%) nonfatal events and 1 (0.4%) fatal event. Plaque burden was significantly related to event-free survival during follow-up (HR:1.11; 95%CI:1.05-1.18; p < 0.001).
Conclusions
Coronary atherosclerosis and its qualitative components may be quantified by means of SAPC in patients with FH. Plaque burden, calcified plaque burden and non-calcified plaque burden were independently related to the estimated cardiovascular risk. Plaque burden was also related to prognosis.

Copyright © 2020 Elsevier B.V. All rights reserved.

Atherosclerosis: 30 Dec 2020; 317:52-58

Outcomes of Percutaneous Coronary Intervention in Patients With Rheumatoid Arthritis.

Dawson LP, Dinh D, O\'Brien J, Duffy SJ, ... Ajani AE,

Rheumatoid arthritis (RA) is the most common inflammatory arthritis and is associated with increased risk of cardiovascular events and mortality. Evidence regarding outcomes following PCI is limited. This study aimed to assess differences in outcomes following percutaneous coronary intervention (PCI) between patients with and without RA. The Melbourne Interventional Group PCI registry (2005 to 2018) was used to identify 756 patients with RA. Outcomes were compared with the remaining cohort (n = 38,579). Patients with RA were older, more often female, with higher rates of hypertension, previous stroke, peripheral vascular disease, obstructive sleep apnea, chronic lung disease, myocardial infarction, and renal impairment, whereas rates of dyslipidemia and current smoking were lower, all p <0.05. Lesions in patients with RA were more frequently complex (ACC/AHA type B2/C), requiring longer stents, with higher rates of no reflow, all p <0.05. Risk of long-term mortality, adjusted for potential confounders, was higher for patients with RA (hazard ratio 1.53, 95% confidence interval 1.30 to 1.80; median follow-up 5.0 years), whereas 30-day outcomes including mortality, major adverse cardiovascular events, bleeding, stroke, myocardial infarction, coronary artery bypass surgery, and target vessel revascularization were similar. In subgroup analysis, patients with RA and lower BMI (P < 0.001) and/or acute coronary syndromes (P = 0.05) had disproportionately higher risk of long-term mortality compared with patients without RA. In conclusion, patients with RA who underwent PCI had more co-morbidities and longer, complex coronary lesions. Risk of short-term adverse outcomes was similar, whereas risk of long-term mortality was higher, especially among patients with acute coronary syndromes and lower body mass index.

Copyright © 2020. Published by Elsevier Inc.

Am J Cardiol: 31 Jan 2021; 140:39-46

Relation of Adiponectin to Cardiovascular Events and Mortality in Patients With Acute Coronary Syndrome.

Nomura H, Arashi H, Yamaguchi J, Ogawa H, Hagiwara N

The association between serum adiponectin levels and cardiovascular events, particularly how adiponectin predicts the development of cardiovascular events and mortality in acute coronary syndrome (ACS) patients remains unresolved. Hence, we aimed to determine whether higher adiponectin levels predict cardiovascular events and mortality in these patients. Regression analyses were performed to clarify adiponectin\'s ability to predict cardiovascular events and mortality among 1,641 ACS patients. Subgroup analyses were performed according to gender, age, and body mass index (BMI). The primary end point was a composite of the first all-cause death, nonfatal myocardial infarction, or nonfatal stroke event. The secondary end point was all-cause death. Hazard ratios for the primary and secondary end points per 5-µg/ml increase in adiponectin levels were 1.31 (95% confidence interval [CI], 1.13 to 1.47; p = 0.0007) and 1.32 (95% CI, 1.13 to 1.51; p = 0.001), respectively. Higher adiponectin levels were associated with increased cardiovascular events in men, patients aged ≥65 years, and those with BMI <25 kg/m. In conclusion, higher adiponectin levels were associated with increased cardiovascular events and all-cause mortality in ACS patients. Its predictive ability might be limited in women, patients aged <65 years, and patients with BMI ≥25 kg/m.

Copyright © 2020 Elsevier Inc. All rights reserved.

Am J Cardiol: 31 Jan 2021; 140:7-12

Usefulness of Thoracic Aortic Calcium to Predict 1-Year Mortality After Transcatheter Aortic Valve Implantation.

Hamandi M, Amiens P, Grayburn PA, Al-Azizi K, ... Harbaoui B, Lantelme P

In patients who underwent transcatheter aortic valve implantation (TAVI), vascular disease is associated with increased risk of mortality. Thoracic aortic calcification (TAC), an objective surrogate of vascular disease, could be a predictor of mortality after TAVI. We aimed to analyze the association between TAC burden and 1-year all-cause mortality in patients who underwent TAVI in a US population. From July 2015 through July 2017, a retrospective review of TAVI procedures was performed at Baylor Scott & White-The Heart Hospital, Plano, Texas. Patients were analyzed for comorbidities, cardiac risk factors, and 30-day and 1-year all-cause mortality. Restricted cubic splines analysis was used to define low, moderate, and high TAC categories. The association between TAC and survival was evaluated using unadjusted and adjusted Cox models. A total of 431 TAVI procedures were performed, of which TAC was measured in 374 (81%) patients. Median (interquartile range) age was 82 (77, 87) years, and 51% were male. Median (interquartile range) STS PROM was 5.6 (4.1, 8.2) %. Overall 30-day and 1-year all-cause mortality was 1% and 10%, respectively. TAC was categorized as low (<1.6 cm), moderate (1.6 to 2.9 cm), and high (>2.9 cm). At 1 year, all-cause mortality was 16% in patients with high TAC compared with 6% in the low and moderate TAC categories (p = 0.008). Unadjusted and adjusted Cox regression analysis showed a significant increase in mortality for patients with high TAC compared with low TAC (hazard ratio 2.98, 95% confidence interval [1.34-6.63]), but not significant compared with moderate TAC group. TAC is a predictor of late mortality after TAVI. In conclusion, adding TAC to preoperative evaluation may provide an objective, reproducible, and potentially widely available tool that can help in shared decision-making.

Copyright © 2020 Elsevier Inc. All rights reserved.

Am J Cardiol: 31 Jan 2021; 140:103-109

Comparison of Prevalence, Presentation, and Prognosis of Acute Coronary Syndromes in ≤35 years, 36 - 54 years, and ≥ 55 years Patients.

Qureshi WT, Kakouros N, Fahed J, Rade JJ

Whether very young patients (≤35-year-old) differ in the prevalence, presentation and prognosis of ACS is not well known. Of 43,446 patients who were referred to a tertiary care cardiac catheterization laboratory between January 1, 2006 and June 30, 2017, 26,545 patients were ACS (defined as ST Elevation MI, Non-ST Elevation MI or unstable angina pectoris). Detailed chart review was performed and characteristics at baseline were compared for ages ≤35 years, ages 36 to 54 years and ages ≥55 years. A total of 291 (1.1%) were ≤35-year-old, 7,649 (28.8) were 36 to 54-year-old and 18,605 (70.1%) were ≥55-year-old. ACS patients aged ≤35-year-old, were more likely to be men, Caucasian white, smoker, obese, and have family history of coronary artery disease and less likely to have comorbidities such as hypertension, diabetes mellitus, and hyperlipidemia compared with older patients. They were also more likely to present with elevated troponin levels than other groups. They also tended to present with late ST elevation myocardial infarction and were more likely to receive bare metal stents than older patients. The prevalence of 2- and 3-vessel disease was lower compared with older patients. They also had higher prevalence of cardiogenic shock. Compared with 36 to 54-year-old patients, ≤35-year-old were at significant higher risk of 30-day mortality in a multivariable adjusted regression model (Odds ratio 5.65, 95% confidence interval 2.49 to 12.82, p <0.001). Very young patients comprised ∼1% of all ACS cases but had much more prevalence of modifiable risk factors and significantly worse mortality. Modifying these risk factors may mitigate the risk in these patients and should be studied in the future.

Copyright © 2020 Elsevier Inc. All rights reserved.

Am J Cardiol: 31 Jan 2021; 140:1-6

Comparison of Outcomes Among Patients with Cardiogenic Shock Admitted on Weekends versus Weekdays.

Harhash AA, Kennedy KF, Fendler TJ, Khumri TM, ... Magalski A, Sperry BW

Cardiogenic shock (CS) is associated with high mortality and often requires involvement of a multidisciplinary provider team to deliver timely care. Care coordination is more difficult on weekends, which may lead to a delay in care. We sought to assess the effect of weekend admissions on outcomes in patients admitted with CS. Patients admitted with CS were identified from 2005-2014 in the National Inpatient Sample using ICD9 code 785.51. Baseline demographics, in-hospital procedures, and outcomes were obtained and compared by day of admission. A multivariable model was used to assess the impact of weekend admission on in-hospital mortality. A total of 875,054 CS admissions were identified (age 67.4 ± 15.1 years, 40.2% female, 72.1% Caucasian), with 23% of patients being admitted on weekends. Baseline comorbidities were similar between groups. Weekend admissions were associated with higher in-hospital mortality (40.6% vs. 37.5%) and cardiac arrest (20.3% vs. 18.1%, p<0.001 for both) consistently over the study period. Use of temporary and permanent mechanical support devices and heart transplantation were slightly less common for weekend admissions. In a multivariable model adjusting for relevant confounders, weekend admission was associated with a 10% increased mortality in patients with CS. In conclusion, patients with CS admitted on weekends had higher in-hospital mortality and were slightly less likely to receive mechanical support and advanced therapies compared to those admitted on weekdays. Future studies and health system initiatives should focus on rectifying these disparities with around-the-clock multidisciplinary coordinated care for cardiogenic shock.

Copyright © 2021 Elsevier Ltd. All rights reserved.

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

An immediate or early invasive strategy in non-ST-elevation acute coronary syndrome: the OPTIMA-2 randomized controlled trial.

Fagel ND, Amoroso G, Vink MA, Slagboom T, ... de Winter RJ, Riezebos RK
Background
In intermediate- and high-risk non-ST elevated acute coronary syndrome (NSTE-ACS) patients, a routine invasive approach is recommended. The timing of coronary angiography remains controversial. To assess whether an immediate (<3 hours) invasive treatment strategy would reduce infarct size and is safe, compared with an early strategy (12-24 hours), for patients admitted with NSTE-ACS while preferably treated with ticagrelor.
Methods
In this single-center, prospective, randomized trial an immediate or early invasive strategy was randomly assigned to patients with NSTE-ACS. At admission, the patients were preferably treated with a combination of aspirin, ticagrelor and fondaparinux. The primary endpoint was the infarct size as measured by area under the curve (AUC) of CK-MB in 48 hours. Secondary endpoints were bleeding outcomes and major adverse cardiac events (MACE): composite of all-cause death, MI and unplanned revascularization. Interim analysis showed futility regarding the primary endpoint and trial inclusion was terminated.
Results
In total 249 patients (71% of planned) were included. The primary endpoint of in-hospital infarct size was a median AUC of CK-MB 186.2 ng/mL in the immediate group [IQR 112-618] and 201.3 ng/mL in the early group [IQR 119-479]. Clinical follow-up was 1-year. The MACE-rate was 10% in the immediate and 10% in the early group (hazard ratio [HR] 1.13, 95% CI: 0.52-2.49).
Conclusions
In NSTE-ACS patients randomized to either an immediate or an early-invasive strategy the observed median difference in the primary endpoint was about half the magnitude of the expected difference. The trial was terminated early for futility after 71% of the projected enrollment had been randomized into the trial.

Copyright © 2021. Published by Elsevier Inc.

Am Heart J: 06 Jan 2021; epub ahead of print

Meta-analysis Evaluating the Utility of Colchicine in Secondary Prevention of Coronary Artery Disease.

Xia M, Yang X, Qian C

Colchicine has shown potential therapeutic benefits in cardiovascular conditions owing to its broad anti-inflammatory properties. Here, we performed a meta-analysis to determine the efficacy and safety of colchicine in patients with coronary artery disease (CAD). A systematical search in electronic databases of PubMed, The Cochrane Library, and Scopus were carried out to identify eligible studies. Only randomized controlled trials evaluating the cardiovascular effects of colchicine in CAD patients were included. Study-level data of cardiovascular outcomes or adverse events were pooled using random-effect models. We finally included 5 randomized controlled trials with follow-up duration ≥6 months, comprising a total of 11,790 patients with CAD. Compared with placebo or no treatment, colchicine administration was associated with a significantly lower incidence of major adverse cardiovascular events (relative risk [RR] 0.65, 95% confidence interval [CI] 0.52 to 0.82). Such a benefit was not modified by the clinical phenotype of CAD (p for interaction = 0.34). Colchicine treatment also decreased the risk of myocardial infarction (RR 0.73, 95% CI 0.55 to 0.98), coronary revascularization (RR 0.61, 95% CI 0.42 to 0.89) and stroke (RR 0.47, 95% CI 0.28 to 0.81) in CAD patients, but with no impact on cardiovascular mortality. In addition, the rates of common adverse events were generally similar between colchicine and control groups, including noncardiovascular deaths (RR 1.50, 95% CI 0.93 to 2.40) and gastrointestinal symptoms (RR 1.05, 95% CI 0.91 to 1.22). In conclusion, the results of our meta-analysis demonstrated that colchicine treatment may reduce the risk of future cardiovascular events in CAD patients.

Copyright © 2020 Elsevier Inc. All rights reserved.

Am J Cardiol: 31 Jan 2021; 140:33-38

Meta-analysis Comparing Outcomes of Percutaneous Coronary Intervention of Native Artery Versus Bypass Graft in Patients With Prior Coronary Artery Bypass Grafting.

Farag M, Gue YX, Brilakis ES, Egred M

Percutaneous coronary intervention (PCI) is common in patients with prior coronary artery bypass graft surgery (CABG), however the data on the association between the PCI target-vessel and clinical outcomes are not clear. We aimed to investigate long-term clinical outcomes of patients with prior CABG who underwent PCI of either bypass graft or native artery. We performed a systematic review and meta-analysis of observational studies comparing PCI of either bypass graft or native artery in patients with prior CABG. Twenty-two studies comprising 40,984 patients were included. The median follow-up duration was 2 (1 to 3) years. Compared with bypass graft PCI, native artery PCI was frequent (61% vs 39%) and was associated with lower major adverse cardiac events (MACE) (odds ratio [OR] 0.51, 95% confidence interval [CI] 0.45 to 0.57, p <0.001), lower all-cause death (OR 0.65, 95% CI 0.49 to 0.87, p = 0.004), lower myocardial infarction (OR 0.56, 95% CI 0.45 to 0.69, p <0.001), and lower target vessel revascularization (TVR) (OR 0.62, 95% CI 0.51to 0.76, p <0.001). There was no significant difference in the early incidence of major bleeding or stroke between the 2 cohorts. In 6 studies involving 2,919 patients with ST-elevation myocardial infarction, there was no significant differences between the 2 cohorts. The increase in TVR risk with bypass graft PCI was associated with MACE. In conclusion, in observational studies involving patients with prior CABG, native artery PCI was associated with lower MACE, all-cause death, myocardial infarction, and TVR compared with bypass graft PCI at a median follow-up of 2 years. Native artery PCI might be considered the preferred treatment for bypass graft failure.

Copyright © 2020 Elsevier Inc. All rights reserved.

Am J Cardiol: 31 Jan 2021; 140:47-54

Discharge Location and Outcomes After Transcatheter Aortic Valve Implantation.

Sweda R, Dobner S, Heg D, Lanz J, ... Windecker S, Stortecky S

The relation between discharge location and outcomes after transcatheter aortic valve implantation (TAVI) is largely unknown. Thus, the objective of this study was to investigate the impact of discharge location on clinical outcomes after TAVI. Between August 2007 and December 2018, consecutive patients who underwent transfemoral TAVI at Bern University Hospital were grouped according to discharge location. Clinical adverse events were adjudicated according to VARC-2 end point definitions. Of 1,902 eligible patients, 520 (27.3%) were discharged home, 945 (49.7%) were discharged to a rehabilitation clinic and 437 (23.0%) were transferred to another institution. Compared with patients discharged to a rehabilitation facility or another institution, patients discharged home were younger (80.8 ± 6.5 vs 82.9 ± 5.4 and 82.8 ± 6.4 years), less likely female (37.3% vs 59.7% and 54.2%), and at lower risk according to STS-PROM (4.5 ± 3.0% vs 5.5 ± 3.8% and 6.6 ± 4.4%). At 1 year follow-up, patients discharged home had similar rates of all-cause mortality (HR 0.82; 95% CI 0.54 to 1.24), cerebrovascular events (HR 1.04; 95% CI 0.52 to 2.08) and bleeding complications (HR 0.93; 95% CI 0.61 to 1.41) compared with patients discharged to a rehabilitation facility. Patients discharged home or to rehabilitation were at lower risk for death (HR 0.37; 95% CI 0.24 to 0.56 and HR 0.44; 95% CI 0.32 to 0.60) and bleeding (HR 0.48; 95% CI 0.30 to 0.76 and HR 0.66; 95% CI 0.45 to 0.96) during the first year after hospital discharge compared with patients transferred to another institution. In conclusion, discharge location is associated with outcomes after TAVI with patients discharged home or to a rehabilitation facility having better clinical outcomes than patients transferred to another institution. Clinical Trial Registration: https://www.clinicaltrials.gov. NCT01368250.

Copyright © 2020 Elsevier Inc. All rights reserved.

Am J Cardiol: 31 Jan 2021; 140:95-102

Systematic review and meta-analysis of the clinical characteristics and outcomes of spontanous coronary artery dissection.

Franke KB, Nerlekar N, Marshall H, Psaltis PJ
Background
Spontaneous coronary artery dissection (SCAD) is an uncommon, non-iatrogenic, non-atherosclerotic cause of acute coronary syndrome. A lack of large prospective cohort studies and randomised controlled trials means that important questions about clinical characteristics and outcomes of patients with SCAD are yet to be fully answered.
Method
A literature search of PUBMED, EMBASE and SCOPUS was undertaken up to and including the 23 January 2020. Studies reporting any cohort of 10 or more SCAD patients presenting with acute coronary syndrome, with appropriate clinical follow-up data were included in the analysis. Incidences of major adverse cardiovascular events (MACE), myocardial infarction and SCAD recurrence were meta-analysed using Poisson regression.
Results
19 studies, totalling p=2,172 patients, were included in the analysis. There was significant heterogeneity across the studies in all baseline characteristics and clinical outcomes. Prevalence of traditional cardiovascular risk factors was low; however, hypertension had a prevalence of 45% (95% CI; [35-54]) and fibromuscular dysplasia (FMD) was present in 68% (95% CI; [61-74]). Across all cohorts, the incidence of MACE in patients with SCAD was 7.80 per 100 person years (n=19, p=2172, 95% CI; [4.50-13.54]) and SCAD recurrence was 5.49 per 100 person years (n=13, p=1408, 95% CI; [3.75-8.02]).
Conclusions
This meta-analysis confirms that SCAD is not an inconsequential cause of acute coronary syndrome and heralds the need for further prospective research to identify predictors of recurrent events and therapies to prevent them.

Crown Copyright © 2020. Published by Elsevier B.V. All rights reserved.

Int J Cardiol: 31 Dec 2020; 322:34-39

Patients with Fontan circulation have abnormal aortic wave propagation patterns: A wave intensity analysis study.

Schäfer M, Frank BS, Jacobsen R, Rausch CM, ... Younoszai A, Di Maria MV
Background
Elevated systemic afterload in patients with Fontan circulation may lead to impaired single ventricular function. Wave intensity analysis (WIA) enables evaluation of compression and expansion waves traveling through vasculature. We aimed to investigate the unfavorable wave propagation causing excessive afterload may be an important contributor to the overall single ventricle function and to the limited functional capacity in this patient population.
Methods
Patients with hypoplastic left heart syndrome (HLHS) (n = 25), single left ventricle (SLV) (n = 24), and normal controls (n = 10) underwent phase-contrast MRI based WIA analysis evaluated in the ascending aorta. Forward compression wave (FCW) representing dP/dt, backward compression wave (BCW) reflecting vascular stiffness, and forward decompression wave (FDW) representing LV relaxation were recorded and indexed to each other.
Results
FCW was lowest in HLHS patients (1098 mm/s), and higher in the SLV group (1457 mm5/s), and controls (6457 mm5/s) (P < 0.001). BCW/FCW was increased in HLHS (0.22) and SLV (0.14) groups compared to controls (0.08) (P = 0.003). Peak VO2 correlated with FCW (R = 0.50, P = 0.015), stroke volume (R = 0.72, P < 0.001), and cardiac output (R = 0.44, P = 0.034).
Conclusions
Patients with HLHS and SLV have unfavorable aortic WIA patterns with increased BCW/FCW ratio indicating increased systemic afterload due to retrograde compression waves. Reduced FCW and systolic MRI indices correlated with peak VO2 suggesting that abnormal systolic wave propagation may play a role in exercise intolerance for Fontan patients.

Copyright © 2020 Elsevier B.V. All rights reserved.

Int J Cardiol: 31 Dec 2020; 322:158-167

Impact of diabetes mellitus on female subjects undergoing transcatheter aortic valve implantation: Insights from the WIN-TAVI international registry.

Goel R, Sartori S, Cao D, Claessen BE, ... Chieffo A, Mehran R
Background
Female subjects constitute half of all transcatheter aortic valve implantation (TAVI) candidates, but the association between important comorbidities such as diabetes mellitus (DM) and clinical outcomes after TAVI remains unclear in this group.
Method
WIN-TAVI is a real-world international registry of exclusively female subjects undergoing TAVI. The study population was stratified into those with (DM) and those without DM (NDM). Valve Academic Research Consortium (VARC)-2 efficacy (composite of all-cause death, stroke, myocardial infarction, hospitalization for valve-related symptoms or worsening congestive heart failure, or valve-related dysfunction) was the primary endpoint for this analysis.
Results
Of the 1012 subjects included in this study, 264 (26.1%) had DM at baseline. DM patients were younger but had a higher burden of comorbidities. There were no differences in VARC-2 efficacy events between DM and NDM patients at 30 days or 1 year. Conversely, patients with DM had a lower risk of VARC-2 life threatening bleeding at 30 days and 1 year after TAVI compared to NDM patients, which remained significant even after multivariable adjustment (HR, 0.34, 95% CI, 0.12-0.99; p = .047). In the subgroup analysis, insulin-dependent DM was not associated with an increased risk of adverse outcomes.
Conclusions
Among female patients undergoing TAVI, more than one-fourth of the subjects presented with DM. At 1-year follow-up, DM was associated with lower bleeding complications and no increase in the risk of other adverse events, including mortality, after TAVI.

Copyright © 2020 Elsevier B.V. All rights reserved.

Int J Cardiol: 31 Dec 2020; 322:65-69

Coronary and aortic calcification are associated with cardiovascular events on immune checkpoint inhibitor therapy.

Schiffer WB, Deych E, Lenihan DJ, Zhang KW
Background
Although the incidence of immune checkpoint inhibitor (ICI)-related cardiovascular (CV) toxicity is low, the overall burden of CV events after ICI is unknown. Risk factors for CV events after ICI have yet to be identified.
Objectives
We sought to evaluate the association between vascular calcification on routine baseline computed tomography (CT) imaging and CV events following ICI.
Method
This was a single-center, retrospective cohort study of 76 patients referred to Cardio-Oncology with prior ICI treatment. Coronary and aortic calcification on non-gated chest and abdominal CT imaging were qualitatively assessed. The association of baseline clinical parameters and vascular calcification with symptomatic heart failure (HF), acute coronary syndrome, myocarditis, symptomatic arrhythmia, or pericardial effusion after ICI was evaluated.
Results
Over 11 months of follow-up, there were 80 CV events that occurred in 49 patients. Worse coronary and aortic calcification on pre-treatment CT imaging was seen in patients with a CV event (p = .018 and p = .014, respectively). There were no differences in traditional CV risk factors between those with and without a CV event. Eighteen patients (37%) were restarted on ICI therapy after a non- myocarditis or symptomatic systolic HF CV event without recurrent events or mortality over 13 months of follow-up.
Conclusions
Symptomatic HF was the most common CV event seen after ICI therapy. Worse coronary and aortic calcification on baseline CT imaging was associated with CV events following ICI. With careful clinical evaluation, selected patients may be re-treated with ICI following a non- myocarditis or symptomatic systolic HF CV event.

Copyright © 2020 Elsevier B.V. All rights reserved.

Int J Cardiol: 31 Dec 2020; 322:177-182

A pairwise meta-analytic comparison of aortic valve area determined by planimetric versus hemodynamic methods in aortic stenosis.

Rong LQ, Hameed I, Di Franco A, Rahouma MM, ... Devereux RB, Gaudino M
Background
Aortic valve area (AVA) is commonly determined from 2-dimensional transthoracic echocardiography (2D TTE) by the continuity equation; however, this method relies on geometric assumptions of the left ventricular outflow tract which may not hold true. This study compared mean differences and correlations for AVA by planimetric (2-dimensional transesophageal echocardiography [2D TEE], 3-dimensional transesophageal echocardiography [3D TEE], 3-dimensional transthoracic echocardiography [3D TTE], multi-detector computed tomography [MDCT], and magnetic resonance imaging [MRI]) with hemodynamic methods (2D TTE and catheterization) using pairwise meta-analysis.
Method
Ovid MEDLINE®, Ovid EMBASE, and The Cochrane Library (Wiley) were queried for studies comparing AVA measurements assessed by planimetric and hemodynamic techniques. Pairwise meta-analysis for mean differences (using random effect model) and for correlation coefficients (r) were performed.
Results
Forty-five studies (3014 patients) were included. Mean differences between planimetric and hemodynamic techniques were 0.12 cm (95%CI 0.10-0.15) for AVA (pooled r = 0.84; 95%CI 0.76-0.90); 1.36cm (95%CI 1.03-1.69) for left ventricular outflow tract area; and 0.13 cm (95%CI 0.07-0.20) for annular diameter (pooled r = 0.76; 95% CI 0.64-0.94); 0.67 cm (95%CI 0.59-0.76) for annular area (pooled r = 0.74; 95%CI 0.55-0.86).
Conclusions
Planimetric techniques slightly, but significantly, overestimate AVA when compared to hemodynamic techniques.

Copyright © 2020 Elsevier B.V. All rights reserved.

Int J Cardiol: 31 Dec 2020; 322:77-85

Circulating CD34+VEGFR-2+ endothelial progenitor cells correlate with revascularization-mediated long-term improvement of cardiac function in patients with coronary chronic total occlusions.

Dai Y, Huang J, Chen Y, Chang S, ... Ge L, Ge J
Background
Endothelial progenitor cells (EPCs) participate in angiogenesis and neocollateralization. This study assessed if circulating EPCs can predict long-term improvement of global left ventricular systolic function in patients with coronary chronic total occlusions (CTOs) underwent successful percutaneous coronary intervention (PCI).
Methods
In this single-center, prospective, observational study, 115 consecutive patients with CTOs were evaluated by standard transthoracic echocardiography (ECHO) before and 9-12 months after PCI. Numbers of circulating putative EPCs were determined by flow cytometry analysis of mononuclear cells isolated from peripheral blood samples drawn before and 72 h after PCI.
Results
At mean 11.3 ± 2.5 months post vs. before PCI (all P < .05): by SAQ-7 summary scores, angina frequency, physical limitation and quality of life scores were greater; by ECHO, LVEDd decreased and LVEF increased, which were more significant in patients with Rentrop grades 2/3 vs. 0/1. At 72 h post vs. before PCI, CD34VEGFR-2CD133 (0.82 ± 0.32 × 10/L vs. 1.00 ± 0.39 × 10/L, P = .003), CD34VEGFR-2CD133 (0.24 ± 0.12 × 10/L vs. 0.27 ± 0.14 × 10/L, P = .028), and CD14Tie2VEGFR-2 (6.60 ± 3.32 × 10/L vs. 7.82 ± 3.91 × 10/L, P = .006) cell numbers were lower. The baseline levels of CD34VEGFR-2cells (P = .001) and CD14Tie2VEGFR-2cells (P < .001) were association with the grade of collateralization. In addition, the baseline and peri-procedural decrease of circulating CD34VEGFR-2 cells correlated with the increase of LVEF (P < .001, P < .001, respectively) and the decrease of LVEDd (P = .022, P = .029, respectively) at follow-up.
Conclusions
In this small study, the baseline levels of circulating CD34VEGFR-2+ EPCs and its reduction after successful revascularization of CTOs correlated with long-term improvement in global LV systolic function.

Copyright © 2020 Elsevier B.V. All rights reserved.

Int J Cardiol: 31 Dec 2020; 322:1-8

Potassium levels as a marker of imminent acute kidney injury among patients admitted with acute myocardial infarction. Soroka Acute Myocardial Infarction II (SAMI-II) Project.

Plakht Y, Gad Saad SN, Gilutz H, Shiyovich A
Background
Acute kidney injury (AKI) is a common complication following acute myocardial infarction (AMI) and associated with worse outcomes. Serum Potassium levels (K, mEq/L), which are regulated by the kidneys, are related with poor prognosis in patients with AMI.
Objectiv
To evaluate whether K levels predict imminent AKI in patients with AMI.
Methods
This retrospective nested case-control study was based on medical records of hospitalized AMI patients, 2002-2012. The cases (AKI group) were defined as an increase of ≥1.5-fold in serum creatinine level or a decrease of ≥25% in the estimated glomerular filtration rate (eGFR) during the hospitalization. The control group comprised of matched randomly selected patients that did not develop AKI. For both groups, all creatinine and K levels were obtained for up-to 72 h prior to the AKI diagnosis (index time).
Results
A total of 12,498/17,678 admissions met the inclusion criteria. The AKI and the control groups consisted of 430 and 1345 matched admission respectively. K levels, prior AKI diagnosis seemed to be higher in the AKI group. Multivariate analysis showed that K ≥ 4.5 within 36-56 h prior to the index time was an independent predictor of the subsequent AKI, OR = 2.3, p < .001. The c-statistic of the model was 0.859, p < .001. Predictivity of K for AKI was stronger among ST-elevation (STEMI) vs. Non-ST-elevation AMI (NSTEMI) patients (OR = 4, p < .001 vs. 1.7, p = .025 respectively; p-for-interaction = 0.038).
Conclusions
K ≥ 4.5 is an independent and incremental marker of imminent AKI in patients with AMI, predictivity is stronger in patients with STEMI than NSTEMI.

Copyright © 2020 Elsevier B.V. All rights reserved.

Int J Cardiol: 31 Dec 2020; 322:214-219

Association of myocardial and serum miRNA expression patterns with the presence and extent of coronary artery disease: A cross-sectional study.

Polyakova EA, Zaraiskii MI, Mikhaylov EN, Baranova EI, Galagudza MM, Shlyakhto EV
Background
MicroRNA (miRNAs) participate in the pathogenesis of coronary artery disease (CAD).
Objective
To evaluate the expressions of myocardial and serum miRNA-27а, miRNA-133а, and miRNA-203 in CAD patients.
Method
This cross-sectional observational study comprised 100 subjects (60.9 ± 1.0 years; 67% men). The right atrial and serum expressions of miRNA-27a, miRNA -133a, and miRNA-203 in 80 patients referred for elective coronary artery bypass graft surgery (CABG) and 20 control patients scheduled for heart valve surgery were analyzed using real-time polymerase chain reaction.
Results
There was a positive correlation between the SYNTAX score I index and serum miRNA-203 expression level (r = 0.693; p < .001). Patients with ≥3 coronary artery lesions had significantly higher myocardial expressions of miRNA-27a, miRNA-133а, and miRNA-203 than patients with 1-2 vessel disease in the atrial myocardium (miRNA-27a: 234.62 ± 29.51 vs. 182.39 ± 19.62 relative expression unit (REU); miRNA-133а: 127.53 ± 13.41 vs. 111.35 ± 12.31 REU; and miRNA-203: 5.25 ± 0.96 vs. 4.71 ± 0.67 REU; р < 0.05); the same association was found for serum miRNA expressions (miRNA-27a: 11.41 ± 3.85 vs. 4.82 ± 1.82 REU; miRNA-133а: 8.42 ± 2.43 vs. 4.35 ± 1.23 REU; and miRNA-203: 145.71 ± 15.73 vs. 43.70 ± 9.67 REU; р < 0.05). The decision tree method established that the risk of multivessel lesions was increased five-fold if the miRNA-203 serum expression was >101.00 REU (OR, 5.90; 95% CI, 2.34-9.46; p < .001).
Conclusions
Both myocardial and serum miRNA-27а, miRNA-133а, and miRNA-203 expressions are higher in CABG patients than in non-CAD subjects. The serum miRNA-203 expression level corresponds to myocardial expression and is strongly correlated with the extent of coronary atherosclerosis.

Copyright © 2020. Published by Elsevier B.V.

Int J Cardiol: 31 Dec 2020; 322:9-15

Relationship between sclerostin and coronary tortuosity in postmenopausal females with non-obstructive coronary artery disease.

Ibrahim IM, Farag EM, Tabl MAE, Abdelaziz M
Background
Coronary tortuosity (CT) is commonly encountered in postmenopausal females and is usually present without obstructive lesions. Circulating sclerostin levels are elevated in postmenopausal females. In view of sclerostin\'s vasculoprotective effect, we aimed to find possible association between circulating sclerostin and CT.
Method
We prospectively enrolled 273 consecutive postmenopausal females with non-obstructive coronary artery disease diagnosed by coronary angiography. Presence and severity (by tortuosity score) of CT as well as serum sclerostin levels were assessed for each patient.
Results
Patients with CT (128, 47% of study group) were significantly older (P < 0.001), with higher prevalence of hypertension (P = 0.001) and had significantly higher levels of both sclerostin (P < 0.001) and hs-CRP (P = 0.001). Multivariate binary logistic regression revealed that the presence of CT (dependent variable) was associated with high sclerostin level (OR 8.9, 95% CI: 4.9-16.2, P < 0.001). Using ROC curve analysis, Sclerostin at a cut-off value of >650 pg/ml was found to be associated with presence of CT (AUC 0.69, 95% CI: 0.61-0.75, P < 0.001) with sensitivity and specificity of 75% and 72.4%, respectively. Using Pearson\'s correlation analysis, significant positive correlation between sclerostin and severity of CT was found (r = 0.29, P = 0.001).
Conclusion
High circulating sclerostin is associated with the presence and severity of CT in postmenopausal females. This may add to the literature on the incompletely understood pathogenesis of CT.

Copyright © 2020 Elsevier B.V. All rights reserved.

Int J Cardiol: 31 Dec 2020; 322:29-33

Association of renal insufficiency with treatments and outcomes in patients with acute coronary syndrome in China.

Peng Y, Du X, Li X, Ji J, ... Patel A,
Background
We aimed to analyze the association of estimated glomerular filtration rate (eGFR) levels of hospitalized patients with treatment decisions and clinical outcomes in Chinese patients with acute coronary syndrome (ACS).
Methods
This was a secondary analysis study from CPACS-2 Program which was a trial of a quality improvement intervention in China and recruited 15,141 patients from 75 hospitals between October 2007 and August 2010. All patients were divided into three groups by the eGFR level on admission. The primary outcomes were several key performance indicators (KPIs) reflecting the management of ACS and the secondary outcomes were clinical outcomes.
Results
A total of 14,437 ACS patients were enrolled in this analysis. Among patients with reduced eGFR levels, fewer patients received appropriate medical therapy (p for trend <0.001) and fewer high-risk patients received coronary angiography (p for trend <0.001) compared to patients with a normal eGFR. Furthermore, 436 cases of death, 357 cases of cardiac death, 686 cases of major adverse cardiovascular events, and 198 cases of major bleeding episodes were reported. Patients with a worse eGFR level had significantly higher rates of death (p for trend <0.001), cardiac death (p for trend <0.001), major adverse cardiovascular events (p for trend <0.001) and major bleeding episodes (p for trend <0.001).
Conclusion
Among Chinese ACS patients, those with renal insufficiency have a lower percentage of adherence to guideline-recommended treatments and worse clinical prognosis. Renal insufficiency is an important factor affecting guideline implementation in Chinese ACS patients.
Clinical trial registration
http://www.anzctr.org.au/default.aspx. Unique identifier: ACTRN12609000491268.

Copyright © 2020 Elsevier B.V. All rights reserved.

Int J Cardiol: 14 Jan 2021; 323:7-12

Psychological and clinical characteristics of patients with spontaneous coronary artery dissection: A case-control study.

Smaardijk VR, Mommersteeg PMC, Kop WJ, Pellegrini D, van Geuns RJ, Maas AHEM
Background
The relative frequency of psychological factors in patients with spontaneous coronary artery dissection (SCAD) compared to patients with traditional atherosclerosis-related type 1 acute coronary syndrome (ACS) is unknown. This study examines whether psychological factors and emotional or physical precipitants are more common in SCAD patients versus atherosclerosis-related ACS patients.
Methods
Participants with SCAD were recruited from a Dutch SCAD database. Given the predominance of SCAD in women (>90%), only female patients were included. The age- and sex-matched atherosclerosis-related ACS group was identified from a registry database. Online questionnaires and medical records were used to investigate psychological factors and clinical information. Univariate and multivariate logistic regression models were used to examine differences between 172 SCAD patients and 76 ACS patients on emotional and physical precipitants prior to the event and psychological factors after the event.
Results
Patients with SCAD were more likely to experience an emotional precipitant in the 24 h prior to the event (56%), compared with the ACS group (39%) (OR = 1.98, 95%CI 1.14-3.44). Multivariate analyses showed that this association remained significant after adjustment for covariates (OR = 2.17, 95%CI 1.08-4.36). At an average of 3.2 years post-hospitalization for the SCAD or atherosclerosis-related ACS event, both patient groups had similar high levels of perceived stress (50% vs. 45%, p = .471) and fatigue (56% vs. 53%, p = .643).
Conclusions
This study shows that risk profiles for SCAD differ from traditional atherosclerosis-related ACS. Our findings may help health professionals to recognize SCAD and offer tailored rehabilitation and prevention programs.

Copyright © 2020 The Author(s). Published by Elsevier B.V. All rights reserved.

Int J Cardiol: 14 Jan 2021; 323:1-6

The impact of transcatheter aortic valve implantation on arterial stiffness and wave reflections.

Terentes-Printzios D, Gardikioti V, Aznaouridis K, Latsios G, ... Tousoulis D, Vlachopoulos C
Background
The study of arterial properties in patients with aortic valve stenosis who undergo transcatheter aortic valve implantation (TAVI) remains challenging and results so far seem equivocal. We sought to investigate the acute and long-term effect of TAVI on arterial stiffness and wave reflections.
Methods
We enrolled 90 patients (mean age 80.2 ± 8.1 years, 50% males) with severe symptomatic aortic stenosis undergoing TAVI. Arterial stiffness was assessed by carotid-femoral and brachial-ankle pulse wave velocity (cfPWV and baPWV). Augmentation index corrected for heart rate ([email protected]), central pressures and subendocardial viability ratio (SEVR) were assessed with arterial tonometry. Measurements were conducted at baseline, after TAVI and at 1 year.
Results
Immediately after TAVI there was an increase in arterial stiffness (7.5 ± 1.5 m/s vs 8.4 ± 1.7 m/s, p = .001 for cfPWV and 1773 ± 459 vs 2383 ± 645 cm/s, p < .001 for baPWV) that was retained at 1 year (7.5 ± 1.5 m/s vs 8.7 ± 1.7 m/s, p < .001 and 1773 ± 459 cm/s vs 2286 ± 575, p < .001). Post-TAVI we also observed a decrease in [email protected] (32.2 ± 12.9% vs 27.9 ± 8.4%, p = .016) that was attenuated 1 year later (32.2 ± 12.9% vs 29.8 ± 9.1%, p = .38), and an increase in SEVR (131.2 ± 30.0% vs 148.4 ± 36.1%, p = .002), which remained improved at 1 year (131.2 ± 30.0% vs 146.0 ± 32.2%, p = .01).
Conclusions
After TAVI the arterial system exhibits an increase of stiffness in response to the acute relief of the obstruction, which is retained in the long term.

Copyright © 2020. Published by Elsevier B.V.

Int J Cardiol: 14 Jan 2021; 323:213-219

The prognostic value of automated coronary calcium derived by a deep learning approach on non-ECG gated CT images from Rb-PET/CT myocardial perfusion imaging.

Dekker M, Waissi F, Bank IEM, Isgum I, ... Timmers L, de Kleijn DPV
Background
Assessment of both coronary artery calcium(CAC) scores and myocardial perfusion imaging(MPI) in patients suspected of coronary artery disease(CAD) provides incremental prognostic information. We used an automated method to determine CAC scores on low-dose attenuation correction CT(LDACT) images gathered during MPI in one single assessment. The prognostic value of this automated CAC score is unknown, we therefore investigated the association of this automated CAC scores and major adverse cardiovascular event(MACE) in a large chest-pain cohort.
Method
We analyzed 747 symptomatic patients referred for RubidiumPET/CT, without a history of coronary revascularization. Ischemia was defined as summed difference score≥2. We used a validated deep learning (DL) method to determine CAC scores. For survival analysis CAC scores were dichotomized as low(<400) and high(≥400). MACE was defined as all cause death, late revascularization (>90 days after scanning) or nonfatal myocardial infarction. Cox proportional hazard analysis were performed to identify predictors of MACE.
Results
During 4 years follow-up, 115 MACEs were observed. High CAC scores showed higher cumulative event rates, irrespective of ischemia (nonischemic: 25.8% vs 11.9% and ischemic: 57.6% vs 23.4%, P-values <0.001). Multivariable cox regression revealed both high CAC scores (HR 2.19 95%CI 1.43-3.35) and ischemia (HR 2.56 95%CI 1.71-3.35) as independent predictors of MACE. Addition of automated CAC scores showed a net reclassification improvement of 0.13(0.022-0.245).
Conclusion
Automatically derived CAC scores determined during a single imaging session are independently associated with MACE. This validated DL method could improve risk stratification and subsequently lead to more personalized treatment in patients suspected of CAD.

Copyright © 2021. Published by Elsevier B.V.

Int J Cardiol: 03 Jan 2021; epub ahead of print

Impact of COVID-19 lockdown on lifestyle adherence in stay-at-home patients with chronic coronary syndromes: Towards a time bomb.

Cransac-Miet A, Zeller M, Chagué F, Faure AS, ... Boulin M, Cottin Y
Background
We aimed to evaluate the impact of coronavirus disease 2019 (COVID-19)-related lockdown on adherence to lifestyle and drug regimens in stay-at-home chronic coronary syndromes patients living in urban and rural areas.
Methods
A cross-sectional population-based study was perfomed in patients with chronic coronary syndromes. A sample of 205 patients was randomly drawn from the RICO (Observatoire des infarctus de Côte d\'Or) cohort. Eight trained interviewers collected data by phone interview during week 16 (April 13 to April 19), i.e. 4 weeks after implementation of the French lockdown (start March 17, 2020).
Results
Among the 195 patients interviewed (of the 205, 3 had died, 1 declined, 6 lost), mean age was 65.5 ± 11.1 years. Only six patients (3%) reported drug discontinuation, mainly driven by media influence or family members. All 166 (85%) patients taking aspirin continued their prescribed daily intake. Lifestyle rules were less respected since almost half (45%) declared >25% reduction in physical activity, 26% of smokers increased their tobacco consumption by >25%, and 24% of patients increased their body weight > 2 kg. The decrease in physical activity and the increase in smoking were significantly greater in urban patients (P < .05).
Conclusions
The COVID-19-related lockdown had a negative impact on lifestyle in a representative sample of stay-at-home CCS patients.

Copyright © 2020. Published by Elsevier B.V.

Int J Cardiol: 14 Jan 2021; 323:285-287

Clinical and Anatomic Complexity of Patients Undergoing Coronary Intervention With and Without On-Site Surgical Capabilities: Insights From the Veterans Affairs Clinical Assessment, Reporting and Tracking (CART) Program.

Waldo SW, Hebbe A, Grunwald GK, Doll JA, Schofield R
Background
Professional society consensus statements articulate the clinical and anatomic complexity of patients that may undergo percutaneous coronary intervention (PCI) without on-site cardiothoracic surgery, although compliance with these recommendations has not been assessed. We sought to evaluate the clinical and anatomic complexity of patients undergoing PCI with and without cardiothoracic surgery on-site.
Methods
We identified all patients undergoing PCI in the Veterans Affairs health care system between October 2009 and September 2017. The clinical and anatomic complexity of patients treated at sites with or without cardiothoracic surgery was evaluated with a comparative interrupted time series, and mortality was ascertained in a propensity-matched cohort.
Results
We identified 75 564 patients who underwent PCI, with the majority (53 708, 71%) treated at sites with cardiothoracic surgery. The overall clinical complexity was statistically greater for those treated at sites with cardiothoracic surgery (National Cardiovascular Data Registries CathPCI: 18.4) compared with those at sites without (17.8, <0.001) throughout the study, with similar annual increases in complexity before (2% versus 3%; =0.107) and after (3% versus 3%; =0.704) January 2014. The anatomic complexity of patients treated was also statistically greater (Veterans Affairs SYNTAX: 11.0 versus 10.2; <0.001) and increased at comparable rates (2% versus 1%, =0.731) before 2014. After publication of the consensus statement, anatomic complexity declined at sites with cardiothoracic surgery (-2%) but increased at sites without on-site surgery (5%, =0.025) such that it was similar at the end of the study (=0.622). Referrals for emergent cardiothoracic surgery were rare regardless of treatment venue (61, 0.08%) and the hazard for mortality was similar (hazard ratio, 0.883 [95% CI, 0.662-1.176]) after propensity matching.
Conclusions
There are minor differences in complexity of patients undergoing coronary intervention at sites with and without cardiothoracic surgery. Clinical outcomes are similar regardless of treatment venue, suggesting an opportunity to improve access to complex interventional care without sacrificing quality.



Circ Cardiovasc Interv: 22 Dec 2020:CIRCINTERVENTIONS120009697; epub ahead of print

Impact of contrast medium osmolality on the risk of acute kidney injury after transcatheter aortic valve implantation: Insights from the magna Graecia TAVI registry.

Iacovelli F, Pignatelli A, Cafaro A, Stabile E, ... Tesorio T, Contegiacomo G
Background
Acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) is frequent and associated with adverse outcomes and mortality; to date, in such setting of patients there is no consistent evidence that either low-osmolar contrast media (LOCM) or isoosmolar contrast medium (IOCM) are superior to the other in terms of renal safety.
Methods
697 consecutive patients not in hemodialysis treatment who underwent TAVI (327 males, mean age 81.01 ± 5.75 years, mean european system for cardiac operative risk evaluation II 6.17 ± 0.23%) were enrolled. According to osmolality of the different iodinated CM, the population was divided in 2 groups: IOCM (n = 370) and LOCM group (n = 327). Preoperatively, 40.54% of patients in IOCM vs 39.14% in LOCM group (p = 0.765) suffered from chronic kidney disease (CKD).
Results
The incidence of AKI was significantly lower with IOCM (9.73%) than with LOCM (15.90%; p = 0.02), and such significant difference (p < 0.001) in postprocedural change of renal function parameters persisted at discharge too. The incidence of AKI was also significantly lower with IOCM in younger patients, without diabetes, anemia, coronary artery disease history, CKD, chronic or persistent atrial fibrillation, left ventricular ejection fraction ≤35%, and in patients with low operative mortality risk scores, receiving lower amounts of dye (p < 0.05 for all). Importantly, multivariate analysis identified LOCM administration as an independent risk factor for both AKI (p = 0.006) and 1-year mortality (p = 0.001).
Conclusions
The use of IOCM have a favorable impact on renal function with respect to LOCM, but it should be considered especially for TAVI patients at lower AKI risk.

Copyright © 2020. Published by Elsevier B.V.

Int J Cardiol: 22 Dec 2020; epub ahead of print

Transcatheter aortic valve replacement after chest radiation: A propensity-matched analysis.

Kherallah RY, Harrison D, Preventza O, Silva GV, ... Coselli JS, Koneru S
Background
Chest radiation therapy (CRT) for malignant thoracic neoplasms is associated with development of valvular heart disease years later. As previous radiation exposure can complicate surgical treatment, transcatheter aortic valve replacement (TAVR) has emerged as an alternative. However, outcomes data are lacking for TAVR patients with a history of CRT.
Methods
We conducted a retrospective study of all patients who underwent a TAVR procedure at a single institution between September 2012 and November 2018. Among 1341 total patients, 50 had previous CRT. These were propensity-matched in a 1:2 ratio to 100 patients without history of CRT. Thirty-day adverse events were analyzed with generalized estimating equation models. Overall mortality was analyzed with stratified Cox regression modelling.
Results
Median clinical follow-up was 24 months (interquartile range [IQR], 12-44 months). There was no difference between CRT and non-CRT patients in overall mortality (hazard ratio [HR] 0.84 [0.37-1.90], P = 0.67), 30-day mortality (HR 3.1 [0.49-20.03], P = 0.23), or 30-day readmission rate (HR 1.0 [0.43-2.31], P = 1). There were no differences in the rates of most adverse events, but patients with CRT history had higher rates of postprocedural respiratory failure (HR 3.63 [1.32-10.02], P = 0.01) and permanent pacemaker implantation (HR 2.84 [1.15-7.01], P = 0.02).
Conclusions
For patients with aortic valve stenosis and previous CRT, TAVR is safe and effective, with outcomes similar to those in the general aortic stenosis population. Patients with history of CRT are more likely to have postprocedural respiratory failure and to require permanent pacemaker implantation.

Copyright © 2020. Published by Elsevier B.V.

Int J Cardiol: 21 Dec 2020; epub ahead of print

Outcomes of transcatheter versus surgical aortic valve replacement among solid organ transplant recipients.

Elbadawi A, Ugwu J, Elgendy IY, Megaly M, ... Goel SS, Gafoor S
Background
There is a paucity of data regarding the outcomes of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) among solid-organ transplant recipients.
Methods
Temporal trends in hospitalizations for aortic valve replacement among solid-organ transplant recipients were determined using the National Inpatient Sample database years 2012-2017. Propensity matching was conducted to compare admissions who underwent TAVR versus SAVR. The primary outcome was in-hospital mortality.
Results
The analysis included 1,730 hospitalizations for isolated AVR; 920 (53.2%) underwent TAVR and 810 (46.7%) underwent SAVR. TAVR was increasingly utilized for solid-organ transplant recipients (P = 0.01), while there was no change in the number of SAVR procedures (P = 0.20). The predictors of undergoing TAVR for solid-organ transplant recipients included older age, diabetes, and prior coronary artery bypass surgery, while TAVR was less likely utilized in small-sized hospitals. TAVR was associated with lower in-hospital mortality after matching (0.9 vs. 4.7%, odds ratio [OR] 0.19; 95% confidence interval [CI] 0.11-0.35, p < .001) and after multivariable adjustment (OR 0.07; 95% CI 0.03-0.21, p < .001). TAVR was associated with lower rate of acute kidney injury, acute stroke, postoperative bleeding, blood transfusion, vascular complications, discharge to nursing facilities, and shorter median length of hospital stay. There was no difference between both groups in the use of mechanical circulatory support, hemodialysis, arrhythmias, or pacemaker insertion.
Conclusion
This contemporary observational nationwide analysis showed that TAVR is increasingly performed among solid-organ transplant recipients. Compared with SAVR, TAVR was associated with lower in-hospital mortality, complications, and shorter length of stay.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 04 Jan 2021; epub ahead of print

Incidence, predictors and outcomes of device-related thrombus after left atrial appendage closure with the WATCHMAN device-Insights from the EWOLUTION real world registry.

Sedaghat A, Nickenig G, Schrickel JW, Ince H, ... Boersma LVA,
Background
In this analysis of the EWOLUTION registry, we evaluated the incidence, relevance and predictors of device-related thrombus in a large multi-center real-world cohort undergoing LAAc with the WATCHMAN device.
Methods and results
We analyzed the 835 patients who underwent percutaneous LAA closure with the WATCHMAN device in the EWOLUTION registry in whom at least one TEE follow up was performed. Patients were 74 ± 9 y/o and were at high risk for stroke and bleeding (CHA2DS2-VASC-Score 4.3 ± 1.7; HAS-BLED-Score 2.3 ± 1.2). Device-related thrombus was detected in 4.1% (34/835) after a median of 54 days (IQR 42-111 days) with 91.2% (31/34) being detected within 3 months after the procedure or at the time of first TEE. Hereby DRT occurred irrespective of postprocedural anticoagulation. Patients with DRT more frequently had long-standing, non-paroxysmal atrial fibrillation (82.4 vs. 64.9%, p < .01), evidence of dense spontaneous echo contrast (26.5 vs. 11.9%, p = .03) and larger LAA diameters at the ostium (22.8 ± 3.5 vs. 21.1 ± 3.5 mm, p < .01) compared to patients without DRT. Left ventricular ejection fraction, device compression ratio and the incidence of renal dysfunction did not differ between the two groups. In a multivariate analysis, only non-paroxysmal atrial fibrillation identified as an independent predictor of developing DRT. Specific treatment of DRT was initiated in 62% (21/34) of patients whereas resolution was confirmed in 86% (18/21) of cases. Overall, no significant differences in annual rates of stroke/TIA or systemic embolism were observed in patients with or without DRT (DRT 1.7 vs. No-DRT 2.2%/year, p = .8).
Conclusions
In real-world patients undergoing LAAc with the WATCHMAN device, DRT is rare. DRT was most frequently detected within the first 3 months after LAAc regardless of post-procedural regimen and was not associated with an increased risk of stroke or SE. While long-standing atrial fibrillation was the only independent factor associated with DRT, medical treatment of DRT resulted in a resolution of thrombi in most cases.

© 2021 Wiley Periodicals LLC.

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

Atrioventricular block with coronary sinus potential dissociation after lateral mitral isthmus block: What is the mechanism?

Nakatani Y, Krisai P, Nakashima T, Tixier R, ... Duchateau J, Pambrun T

A 61-year-old man was referred to our institution for ablation of an atrial tachycardia (AT) occurring after previous ablation of atrial fibrillation (AF). This article is protected by copyright. All rights reserved.

This article is protected by copyright. All rights reserved.

J Cardiovasc Electrophysiol: 10 Jan 2021; epub ahead of print

Endovascular snare technique to facilitate delivery of self-expanding valve during transcatheter aortic valve-in-valve replacement in angulated aortas: A case series.

Rohm CL, Farhat S, Al-Hijji M, Goel K, ... Gulati R, El Sabbagh A
Background
Transcatheter aortic valve-in-valve replacement (ViV) has been widely accepted as a less invasive alternative to treat failed aortic surgical or transcatheter bioprosthetic valves. Angulated aortas present an additional challenge, particularly when using self-expanding transcatheter heart valves (SE-THV).
Methods
Two patients with failed surgical bioprosthetic aortic valves and one patient with a failed transcatheter bioprosthetic aortic valve underwent transcatheter aortic ViV using SE-THV. All were deemed high-risk for surgical aortic valve replacement by a heart team. All three patients had initial failed SE-THV delivery using a conventional approach with subsequent successful delivery using the endovascular snare technique.
Results
In Cases 1 and 2, the SE-THV was biased towards the greater curve of the angulated aorta and behind the outer frame of the bioprosthetic valve frame. An endovascular snare was deployed through a secondary left femoral artery access, and the valve delivery system was advanced through the snare in the ascending aorta. The snare was tightened around the SE-THV capsule proximal to the hat-marker, allowing deflection of the SE-THV and successful delivery. In Case 3, the SE-THV interacted with the tall frame of a failed SE-THV. A snare via the left femoral artery was deployed in the descending artery. The SE-THV was advanced through the snare, and both the snare and SE-THV were advanced together to the ascending aorta where the SE-THV was deflected and successfully delivered.
Conclusions
The endovascular snare technique is a feasible option for successful delivery of SE-THV during transcatheter aortic ViV in failed transcatheter or surgical bioprosthetic valves in angulated aortas.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 10 Jan 2021; epub ahead of print

Amplatzer device closure of femoral pseudoaneurysm after transcatheter aortic valve implantation: An alternative to surgical repair.

Tanseco KV, Alsanjari O, Cockburn J, Hildick-Smith D

Iatrogenic femoral artery pseudoaneurysm is an infrequent but troublesome complication of vascular access during transcatheter aortic valve implantation. There are non-invasive, percutaneous and surgical treatment options for management of this complication. This case series report demonstrates a novel technique using an Amplatzer Duct Occluder II closure device to successfully treat iatrogenic common femoral pseudoaneurysm following transcatheter aortic valve implantation.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 21 Dec 2020; epub ahead of print

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: 27 Dec 2020; epub ahead of print

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: 28 Dec 2020; epub ahead of print

Safety of same-day discharge after uncomplicated, minimalist transcatheter aortic valve replacement in the COVID-19 era.

Perdoncin E, Greenbaum AB, Grubb KJ, Babaliaros VC, ... Mitchell R, Devireddy CM
Objectives
We sought to evaluate the safety, efficacy and feasibility of same-day discharge after uncomplicated, minimalist TAVR.
Background
At the start of the COVID-19 pandemic, we created a same-day discharge (SDD) pathway after conscious sedation, transfemoral (minimalist) TAVR to help minimize risk of viral transmission and conserve hospital resources. Studies support that next-day discharge (NDD) for carefully selected patients following minimalist TAVR is safe and feasible. There is a paucity of data regarding the safety of SDD after TAVR.
Methods
In-hospital and 30 day outcomes of consecutive patients meeting pre-specified criteria for SDD after minimalist TAVR at our institution between March and July of 2020 were reviewed. Outcomes were compared to a NDD cohort from July 2018 through July 2020 that would have met SDD criteria. Primary endpoints were mortality, delayed pacemaker placement, stroke and cardiovascular readmission at 30 days.
Results
Twenty nine patients were discharged via the SDD pathway after TAVR. 128 prior NDD patients were identified who met all criteria for SDD. The STS scores were similar between the two groups (SDD 2.6% ±1.5 vs. NDD 2.3% ± 1.2). There were no deaths at 30 days in either group. There was no significant difference in delayed pacemaker placement (SDD 0% vs. NDD 0.8%, p > .99) or cardiovascular readmission (SDD 0% vs. NDD 5.5%, p = .35) at 30 days.
Conclusions
Same day discharge following uncomplicated, minimalist TAVR in selected patients appears to be safe, achieving similar 30 day outcomes as a cohort of next day discharge patients.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Dec 2020; epub ahead of print

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: 08 Jan 2021; epub ahead of print

Development and validation of a prediction model for angiographic perforation during chronic total occlusion percutaneous coronary intervention: OPEN-CLEAN perforation score.

Hirai T, Grantham JA, Sapontis J, Nicholson WJ, ... Salisbury AC, OPEN CTO Study Group
Background
Perforation is the most frequent complication of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) and is associated with adverse events including mortality.
Methods
Among 1,000 consecutive patients enrolled in 12 center prospective CTO PCI study (OPEN CTO), all perforations were reviewed by the angiographic core-lab. Eighty-nine patients (8.9%) with angiographic perforation were compared to 911 patients without perforation. We sought to describe the clinical and angiographic predictors of angiographic perforation during CTO PCI and develop a risk prediction model.
Results
Among eight clinically important candidate variables, independent risk factors for perforation included prior CABG (OR 2.0 [95% CI, 1.2-3.3], p < .01), occlusion length (OR 1.2 per 10 mm increase [95% CI, 1.1-1.3], p < .01), ejection fraction (OR 1.2 per 10% decrease [95% CI, 1.1-1.5], p < .01), age (OR 1.3 per 5 year increase [95%CI, 1.1-1.5], p < .01), and heavy calcification (OR 1.7 [95% CI, 1.0-2.7], p = .04). Three other potential candidate variables, glomerular filtration rate, proximal cap ambiguity, and target vessel, were not independently associated with perforation. The model was internally validated using bootstrapping methods. From the full model, a simplified perforation prediction score (OPEN-CLEAN score: CABG, Length [occlusion], EF < 50%, Age, CalcificatioN) was developed, which discriminated the risk of angiographic perforation well (c-statistics = 0.75) and demonstrated good calibration.
Conclusion
This simple 5-variable prediction score may help CTO operators to risk-stratify patients for angiographic perforation using variables available prior to CTO PCI procedures.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 12 Jan 2021; epub ahead of print

Dedicated plug based closure for large bore access -The MARVEL prospective registry.

Kroon HG, Tonino PAL, Savontaus M, Amoroso G, ... Wood D, Van Mieghem NM
Objectives
To study safety and performance of the MANTA Vascular closure device (VCD) under real world conditions in 10 centers.
Background
The MANTA is a novel plug-based device for large bore arteriotomy closure.
Methods
We included all eligible patients who underwent transfemoral large bore percutaneous procedures. Exclusion criteria were per operator\'s discretion and included severe calcification or marked tortuosity of the access vessel, presence of marked obesity/cachexia or a systolic blood pressure above 180 mmHg. The primary performance endpoint was time to hemostasis. Primary and secondary safety endpoints were major and minor access site related vascular complications up to 30 days, respectively. Vascular complications were adjudicated by an independent clinical event committee according to VARC-2 criteria. We performed multivariable logistic regression to estimate the effect of baseline and procedural characteristics on any and major vascular complications.
Results
Between February 2018 and July 2019 500 patients were enrolled undergoing Transcatheter aortic valve replacement (TAVR, N = 496), Balloon aortic valvuloplasty (BAV, N = 2), Mechanical circulatory support (MCS, N = 1) or Endovascular aneurysm repair (EVAR, N = 1). Mean age was 80.8 ± 6.6 years with a median STS-score of 2.7 [IQR 2.0-4.3] %. MANTA access site complications were major in 20 (4%) and minor in 28 patients (5.6%). Median time to hemostasis was 50 [IQR 20-120] sec. Severe femoral artery calcification, scar presence in groin, longer procedure duration, female gender and history of hypertension were independent predictors for vascular complications.
Conclusion
In this study, MANTA appeared to be a safe and effective device for large bore access closure under real-world conditions.

© 2020 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 20 Dec 2020; epub ahead of print