Impact of Peri-Procedural Myocardial Infarction on Outcomes After Revascularization.

Hara H, Serruys PW, Takahashi K, Kawashima H, ... Mack MJ,
Background
Numerous definitions for peri-procedural myocardial infarction (PMI) following percutaneous coronary intervention (PCI) and coronary bypass grafting (CABG) surgery exist.
Objectives
The purpose of this study was to investigate the PMI rates according to various definitions, their clinically relevant association with all-cause mortality at 10 years, and their impact on composite endpoints at 5 years in the SYNTAXES (Synergy between PCI with Taxus and Cardiac Surgery Extended Survival) trial.
Methods
PMI was classified as a myocardial infarction occurring within 48 h of the procedure according to definitions of the SYNTAX (TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries), ISCHEMIA (International Study Of Comparative Health Effectiveness With Medical And Invasive Approaches), and EXCEL (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trials; the Fourth Universal Definition of MI; and the Society for Cardiovascular Angiography and Interventions (SCAI). Of the 1,800 patients enrolled, 1,652 with creatine kinase and/or creatine kinase-myocardial band (CK-MB) post-procedure were included. The association between PMI and mortality was analyzed by Cox regression.
Results
PMI rates according to the SYNTAX and Fourth Universal Definition of MI, both of which required CK-MB elevation and electrocardiographic evidence of permanent myocardial damage, were 2.7% and 3.0%, respectively, in the PCI arm versus 2.4% and 2.1%, respectively, in the CABG arm. PMI rates according to the SCAI or EXCEL definition were higher in the PCI (5.7%) and CABG (16.5%) arms. PMIs according to the SYNTAX and Fourth Universal Definition of MI were more strongly associated with mortality than EXCEL and SCAI PMIs defined by isolated enzyme elevation when CK-MB was more than 10 times ULN. The impact of these \"enzyme-driven events\" on time-to-event curves and the composite endpoints was greater in the surgical cohort. PMIs after PCI were associated with 10-year mortality regardless of definition, whereas their impact on mortality after CABG was limited to 1 year.
Conclusions
The rates of PMI are highly dependent on their definition, which affects time-to-event curves, composite endpoints, and their lethal prognostic relevance. (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES]; NCT03417050; SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX]; NCT00114972).

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

J Am Coll Cardiol: 05 Oct 2020; 76:1622-1639

Ross Procedures in Children With Previous Aortic Valve Surgery.

Buratto E, Wallace FRO, Fricke TA, Brink J, ... Brizard CP, Konstantinov IE
Background
The Ross procedure in children is performed either as a primary operation, or a secondary operation after initial aortic valve surgery.
Objectives
The study aimed to determine whether the outcomes of primary and secondary Ross procedure are similar.
Methods
All patients who underwent Ross procedure between 1995 and 2018 were included in the study. Outcomes were compared between those who had primary Ross procedure and those who had secondary Ross procedure, after aortic valve surgery. Propensity score matching for baseline characteristics and risk factors for death and reoperation was performed.
Results
Of 140 Ross procedures, 51.4% (n = 72 of 140) were primary operations, while 48.6% (n = 68 of 140) were secondary operations. Patients undergoing primary Ross procedure tended to be older (median age 8.6 years vs. 7.0 years; p = 0.10) and have a higher weight (28.9 kg vs. 19.4 kg; p = 0.07). There were no significant differences in survival or freedom from reoperation in the unmatched cohort. Propensity score matching resulted in 50 well-matched pairs. In the matched cohort, survival at 10 years was 90.0% (95% confidence interval [CI]: 77.5% to 95.7%) in the primary Ross group, compared with 96.8% (95% CI: 79.2% to 99.5%) in the secondary Ross group (p = 0.04). Freedom from autograft reoperation at 10 years was 82% (95% CI: 64.1% to 91.5%) in the primary Ross group, compared with 97.0% (95% CI: 80.4% to 99.6%) in the secondary Ross group (p = 0.03).
Conclusions
Secondary Ross procedure performed after initial aortic valve surgery achieves superior long-term survival and freedom from autograft reoperation compared with primary Ross procedure. A strategy of initial aortic valve repair followed by delayed Ross procedure may provide better long-term survival and freedom from autograft reoperation.

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

J Am Coll Cardiol: 28 Sep 2020; 76:1564-1573

Trends and Outcomes of Restenosis After Coronary Stent Implantation in the United States.

Moussa ID, Mohananey D, Saucedo J, Stone GW, ... Moses JW, Simonton C
Background
There is a paucity of data on the burden of in-stent restenosis (ISR) in the United States as well as on its presentation and appropriate treatment strategies.
Objectives
This study aims to provide an analysis of the temporal trends, clinical presentation, treatment strategies, and in-hospital outcomes of patients undergoing percutaneous coronary intervention (PCI) for ISR in the United States.
Methods
This study is a retrospective analysis of data collected in the Diagnostic Catheterization and Percutaneous Coronary Intervention (CathPCI) registry of the National Cardiovascular Data Registry (NCDR) between 2009 and 2017. Of the total patients undergoing PCI, we identified those undergoing PCI for ISR lesions. For comparison of in-hospital outcomes, propensity-score matching was employed.
Results
Among the 5,100,394 patients undergoing PCI, 10.6% of patients underwent PCI for ISR lesions. Patients with bare-metal stent ISR declined from 2.6% in 2009 Q3 to 0.9% in 2017 Q2 (p < 0.001), and drug-eluting stent ISR rose from 5.4% in 2009 Q3 to 6.3% in 2017 Q2 (p < 0.001). Patients with ISR PCI were less likely to present with non-ST-segment elevation myocardial infarction (MI) (18.7% vs. 22.5%; p < 0.001) or ST-segment elevation MI (8.5% vs. 15.7%; p < 0.001). In the propensity-matched population of patients, there were no significant differences between patients with ISR and non-ISR PCI for in-hospital complications and hospital length of stay.
Conclusions
ISR represents approximately 10% of all PCI and is treated most commonly with another stent. Approximately 25% of patients present with acute MI. In-hospital outcomes of patients with ISR PCI are comparable with those undergoing non-ISR PCI.

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

J Am Coll Cardiol: 28 Sep 2020; 76:1521-1531

Association of Bioprosthetic Aortic Valve Leaflet Calcification on Hemodynamic and Clinical Outcomes.

Zhang B, Salaun E, Côté N, Wu Y, ... Pibarot P, Clavel MA
Background
The prognostic value of aortic valve calcification (AVC) measured by using multidetector computed tomography imaging has been well validated in native aortic stenosis, and sex-specific thresholds have been proposed. However, few data are available regarding the impact of leaflet calcification on outcomes after biological aortic valve replacement (AVR).
Objectives
The goal of this study was to analyze the association of quantitative bioprosthetic leaflet AVC with hemodynamic and clinical outcomes, as well as its possible interaction with sex.
Methods
From 2008 to 2010, a total of 204 patients were prospectively enrolled with a median of 7.0 years (interquartile range: 5.1 to 9.2 years) after biological surgical AVR. AVC measured by using the Agatston method was indexed to the cross-sectional area of aortic annulus measured by echocardiography to calculate the AVC density (AVCd). Presence of hemodynamic valve deterioration (HVD; increase in mean gradient [MG] ≥10 mm Hg and/or increase in transprosthetic regurgitation ≥1) was assessed by echocardiography in 137 patients at the 3-year follow-up. The primary clinical endpoint was mortality or aortic valve re-intervention.
Results
There was no significant sex-related difference in the relationship between bioprosthetic AVCd and the progression of MG. Baseline AVCd showed an independent association with HVD at 3 years. During follow-up, there were 134 (65.7%) deaths (n = 100) or valve re-interventions (n = 47). AVCd ≥58 AU/cm was independently associated with an increased risk of mortality or aortic valve re-intervention (adjusted hazard ratio: 2.23; 95% confidence interval: 1.44 to 3.35; p < 0.001). The AVCd threshold combined with an MG progression threshold of 10 mm Hg amplified the stratification of patients at risk (log-rank, p < 0.001). The addition of AVCd threshold into the prediction model including traditional risk factors improved outcome prediction (net classification improvement: 0.25, p = 0.04; likelihood ratio test, p < 0.001).
Conclusions
Aortic bioprosthetic leaflet calcification is strongly and independently associated with HVD and the risk of death or aortic valve re-intervention. As opposed to native aortic stenosis, there is no sex-related differences in the relationship between AVCd and hemodynamic or clinical outcomes.

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

J Am Coll Cardiol: 12 Oct 2020; 76:1737-1748

Type A Aortic Dissection-Experience Over 5 Decades: JACC Historical Breakthroughs in Perspective.

Zhu Y, Lingala B, Baiocchi M, Tao JJ, ... Fischbein MP, Woo YJ

The Stanford classification of aortic dissection was described in 1970. The classification proposed that type A aortic dissection should be surgically repaired immediately, whereas type B aortic dissection can be treated medically. Since then, diagnostic tools and management of acute type A aortic dissection (ATAAD) have undergone substantial evolution. This paper evaluated historical changes of ATAAD repair at Stanford University since the establishment of the aortic dissection classification 50 years ago. The surgical approaches to the proximal and distal extent of the aorta, cerebral perfusion methods, and cannulation strategies were reviewed. Additional analyses using patients who underwent ATAAD repair at Stanford University from 1967 through December 2019 were performed to further illustrate the Stanford experience in the management of ATAAD. While technical complexity increased over time, post-operative survival continued to improve. Further investigation is warranted to delineate factors associated with the improved outcomes observed in this study.

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

J Am Coll Cardiol: 05 Oct 2020; 76:1703-1713

Implications of Alternative Definitions of Peri-Procedural Myocardial Infarction After Coronary Revascularization.

Gregson J, Stone GW, Ben-Yehuda O, Redfors B, ... Serruys PW, Pocock SJ
Background
Varying definitions of procedural myocardial infarction (PMI) are in widespread use.
Objectives
This study sought to determine the rates and clinical relevance of PMI using different definitions in patients with left main coronary artery disease randomized to percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) surgery in the EXCEL (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial.
Methods
The pre-specified protocol definition of PMI (PMI) required a large elevation of creatine kinase-MB (CK-MB), with identical threshold for both procedures. The Third Universal Definition of MI (types 4a and 5) (PMI) required lesser biomarker elevations but with supporting evidence of myocardial ischemia, different after PCI and CABG. For the PMI, troponins were used preferentially (available in 49.5% of patients), CK-MB otherwise. The multivariable relationship between each PMI type and 5-year mortality was determined.
Results
PMI occurred in 34 of 935 (3.6%) patients after PCI and 56 of 923 (6.1%) patients after CABG (difference -2.4%; 95% confidence interval [CI]: -4.4% to -0.5%; p = 0.015). The corresponding rates of PMI were 37 (4.0%) and 20 (2.2%), respectively (difference 1.8%; 95% CI: 0.2% to 3.4%; p = 0.025). Both PMI and PMI were associated with 5-year cardiovascular mortality (adjusted hazard ratio [HR]: 2.18 [95% CI: 1.13 to 4.23] and 2.87 [95% CI: 1.44 to 5.73], respectively). PMI was associated with a consistent hazard of cardiovascular mortality after both PCI and CABG (p = 0.86). Conversely, PMI was strongly associated with cardiovascular mortality after CABG (adjusted HR: 11.94; 95% CI: 4.84 to 29.47) but not after PCI (adjusted HR: 1.14; 95% CI: 0.35 to 3.67) (p = 0.004). Results were similar for all-cause mortality and with varying PMI biomarker definitions. Only large biomarker elevations (CK-MB ≥10× upper reference limit and troponin ≥70× upper reference limit) were associated with mortality.
Conclusions
The rates of PMI after PCI and CABG vary greatly with different definitions. In the EXCEL trial, the pre-specified PMI was associated with similar hazard after PCI and CABG, whereas PMI was strongly associated with mortality after CABG but not after PCI. (EXCEL Clinical Trial [EXCEL]; NCT01205776).

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

J Am Coll Cardiol: 05 Oct 2020; 76:1609-1621

Sex Differences in Incident and Recurrent Coronary Events and All-Cause Mortality.

Peters SAE, Colantonio LD, Chen L, Bittner V, ... Muntner P, Woodward M
Background
Women have lower age-specific rates of incident coronary heart disease (CHD) than men. It is unclear whether women remain at lower risk for CHD events versus men following a myocardial infarction (MI).
Objectives
This study assessed sex differences in recurrent MI, recurrent CHD events, and mortality among patients with MI and compared these associations with sex differences in a control group without a history of CHD.
Methods
This study analyzed data for 171,897 women and 167,993 men age 21 years or older with health insurance in the United States who had a MI hospitalization in 2015 or 2016. Patients with a MI were frequency matched by age and calendar year to 687,588 women and 671,972 men without CHD. Beneficiaries were followed until December 2017 for MI, CHD (i.e., MI or coronary revascularization), and in Medicare for all-cause mortality.
Results
Age-standardized rates of MI per 1,000 person-years were 4.5 in women and 5.7 in men without CHD (hazard ratio [HR]: 0.64; 95% confidence interval [CI]: 0.62 to 0.67) and 60.2 in women and 59.8 in men with MI (HR: 0.94; 95% CI: 0.92 to 0.96). CHD rates in women versus men were 6.3 versus 10.7 among those without CHD (HR: 0.53; 95% CI: 0.51 to 0.54) and 84.5 versus 99.3 among those with MI (HR: 0.87; 95% CI: 0.85 to 0.89). All-cause mortality rates in women versus men were 63.7 versus 59.0 among those without CHD (HR: 0.72; 95% CI: 0.71 to 0.73) and 311.6 versus 284.5 among those with MI (HR: 0.90; 95% CI: 0.89 to 0.92).
Conclusions
The lower risk for MI, CHD, and all-cause mortality in women versus men is considerably attenuated following a MI.

Copyright © 2020. Published by Elsevier Inc.

J Am Coll Cardiol: 12 Oct 2020; 76:1751-1760

Incidence, Characteristics, Predictors, and Outcomes of Surgical Explantation After Transcatheter Aortic Valve Replacement.

Hirji SA, Percy ED, McGurk S, Malarczyk A, ... Shah PB, Kaneko T
Background
Currently, there is a paucity of information on surgical explantation after transcatheter aortic valve replacement (TAVR).
Objectives
The purpose of this study was to examine the incidence, patient characteristics, predictors, and outcomes of surgical explantation after TAVR using a population-based, nationally representative database.
Methods
We analyzed the Medicare Provider profile to include all U.S. patients undergoing TAVR from 2012 to 2017. Time to surgical explant was calculated from the index TAVR discharge to surgical explantation. Post-operative survival was assessed using time-dependent Cox proportional hazard regression analysis and landmark analysis.
Results
The incidence of surgical explantation was 0.2% (227 of 132,633 patients), and was 0.28% and 0.14% in the early and newer TAVR era, respectively. The median time to surgical explant was 212 days, whereas 8.8% and 70.9% underwent surgical explantation within 30 days and 1 year, respectively. The primary indication for reintervention was bioprosthetic failure (79.3%). Compared with the no-explant cohort, the explant cohort was significantly younger (mean age 73.7 years vs. 81.7 years), with a lower prevalence of heart failure (55.9% vs. 65.8%) but more likely a lower-risk profile cohort (15% vs. 2.4%; all p < 0.05). The 30-day and 1-year mortality rates were 13.2% and 22.9%, respectively, and did not vary by either time to surgical explant or TAVR era, or between patients with versus without endocarditis (all p > 0.05). The time-dependent Cox regression analysis demonstrated a higher mortality in those with surgical explantation (hazard ratio: 4.03 vs. no-explant group; 95% confidence interval: 1.81 to 8.98). Indication, time-to-surgical-explant, and year of surgical explantation were not associated with worse post-explantation survival (all p > 0.05).
Conclusions
The present study provides updated evidence on the incidence, timing, and outcomes of surgical explantation of a TAVR prosthesis. Although the overall incidence was low, short-term mortality was high. These findings stress the importance of future mechanistic studies on TAVR explantation and may have implications on lifetime management of aortic stenosis, particularly in younger patients.

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

J Am Coll Cardiol: 19 Oct 2020; 76:1848-1859

Structural Deterioration of Transcatheter Versus Surgical Aortic Valve Bioprostheses in the PARTNER-2 Trial.

Pibarot P, Ternacle J, Jaber WA, Salaun E, ... Hahn RT,
Background
It is unknown whether transcatheter valves will have similar durability as surgical bioprosthetic valves. Definitions of structural valve deterioration (SVD), based on valve related reintervention or death, underestimate the incidence of SVD.
Objectives
This study sought to determine and compare the 5-year incidence of SVD, using new standardized definitions based on echocardiographic follow-up of valve function, in intermediate-risk patients with severe aortic stenosis given transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) in the PARTNER (Placement of Aortic Transcatheter Valves) 2A trial and registry.
Methods
In the PARTNER 2A trial, patients were randomly assigned to receive either TAVR with the SAPIEN XT or SAVR, whereas in the SAPIEN 3 registry, patients were assigned to TAVR with the SAPIEN 3. The primary endpoint was the incidence of SVD, that is, the composite of SVD-related hemodynamic valve deterioration during echocardiographic follow-up and/or SVD-related bioprosthetic valve failure (BVF) at 5 years.
Results
Compared with SAVR, the SAPIEN-XT TAVR cohort had a significantly higher 5-year exposure adjusted incidence rates (per 100 patient-years) of SVD (1.61 ± 0.24% vs. 0.63 ± 0.16%), SVD-related BVF (0.58 ± 0.14% vs. 0.12 ± 0.07%), and all-cause (structural or nonstructural) BVF (0.81 ± 0.16% vs. 0.27 ± 0.10%) (p ≤ 0.01 for all). The 5-year rates of SVD (0.68 ± 0.18% vs. 0.60 ± 0.17%; p = 0.71), SVD-related BVF (0.29 ± 0.12% vs. 0.14 ± 0.08%; p = 0.25), and all-cause BVF (0.60 ± 0.15% vs. 0.32 ± 0.11%; p = 0.32) in SAPIEN 3 TAVR were not significantly different to a propensity score matched SAVR cohort. The 5-year rates of SVD and SVD-related BVF were significantly lower in SAPIEN 3 versus SAPIEN XT TAVR matched cohorts.
Conclusions
Compared with SAVR, the second-generation SAPIEN XT balloon-expandable valve has a higher 5-year rate of SVD, whereas the third-generation SAPIEN 3 has a rate of SVD that was not different from SAVR. (The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII A [PARTNERII A]; NCT01314313; The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - PARTNER II - PARTNERII - S3 Intermediate [PARTNERII S3i]; NCT03222128).

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

J Am Coll Cardiol: 19 Oct 2020; 76:1830-1843

Differential immunological signature at the culprit site distinguishes acute coronary syndrome with intact from acute coronary syndrome with ruptured fibrous cap: results from the prospective translational OPTICO-ACS study.

Leistner DM, Kränkel N, Meteva D, Abdelwahed YS, ... Libby P, Landmesser U
Aims 
Acute coronary syndromes with intact fibrous cap (IFC-ACS), i.e. caused by coronary plaque erosion, account for approximately one-third of ACS. However, the underlying pathophysiological mechanisms as compared with ACS caused by plaque rupture (RFC-ACS) remain largely undefined. The prospective translational OPTICO-ACS study programme investigates for the first time the microenvironment of ACS-causing culprit lesions (CL) with intact fibrous cap by molecular high-resolution intracoronary imaging and simultaneous local immunological phenotyping.
Methods and results 
The CL of 170 consecutive ACS patients were investigated by optical coherence tomography (OCT) and simultaneous immunophenotyping by flow cytometric analysis as well as by effector molecule concentration measurements across the culprit lesion gradient (ratio local/systemic levels). Within the study cohort, IFC caused 24.6% of ACS while RFC-ACS caused 75.4% as determined and validated by two independent OCT core laboratories. The IFC-CL were characterized by lower lipid content, less calcification, a thicker overlying fibrous cap, and largely localized near a coronary bifurcation as compared with RFC-CL. The microenvironment of IFC-ACS lesions demonstrated selective enrichment in both CD4+ and CD8+ T-lymphocytes (+8.1% and +11.2%, respectively, both P < 0.05) as compared with RFC-ACS lesions. T-cell-associated extracellular circulating microvesicles (MV) were more pronounced in IFC-ACS lesions and a significantly higher amount of CD8+ T-lymphocytes was detectable in thrombi aspirated from IFC-culprit sites. Furthermore, IFC-ACS lesions showed increased levels of the T-cell effector molecules granzyme A (+22.4%), perforin (+58.8%), and granulysin (+75.4%) as compared with RFC plaques (P < 0.005). Endothelial cells subjected to culture in disturbed laminar flow conditions, i.e. to simulate coronary flow near a bifurcation, demonstrated an enhanced adhesion of CD8+T cells. Finally, both CD8+T cells and their cytotoxic effector molecules caused endothelial cell death, a key potential pathophysiological mechanism in IFC-ACS.
Conclusions 
The OPTICO-ACS study emphasizes a novel mechanism in the pathogenesis of IFC-ACS, favouring participation of the adaptive immune system, particularly CD4+ and CD8+ T-cells and their effector molecules. The different immune signatures identified in this study advance the understanding of coronary plaque progression and may provide a basis for future development of personalized therapeutic approaches to ACS with IFC.
Trial registration
The study was registered at clinicalTrials.gov (NCT03129503).

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: 19 Oct 2020; epub ahead of print

Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Artery Disease: The Disrupt CAD III Study.

Hill JM, Kereiakes DJ, Shlofmitz RA, Klein AJ, ... Waksman R, Stone GW
Background
Coronary calcification hinders stent delivery and expansion and is associated with adverse outcomes. Intravascular lithotripsy (IVL) delivers acoustic pressure waves to modify calcium, enhancing vessel compliance and optimizing stent deployment.
Objective
To assess the safety and effectiveness of IVL in severely calcified de novo coronary lesions.
Methods
Disrupt CAD III (NCT03595176) was a prospective, single-arm multicenter study designed for regulatory approval of coronary IVL. The primary safety endpoint was freedom from major adverse cardiovascular events (MACE: cardiac death, myocardial infarction or target vessel revascularization) at 30 days. The primary effectiveness endpoint was procedural success. Both endpoints were compared to a pre-specified performance goal (PG). The mechanism of calcium modification was assessed in an optical coherence tomography (OCT) sub-study.
Results
Patients (n=431) were enrolled at 47 sites in four countries. The primary safety endpoint of the 30-day freedom from MACE was 92.2%; the lower bound of the 95% confidence interval (CI) was 89.5% which exceeded the PG of 84.4% (P<0.0001). The primary effectiveness endpoint of procedural success was 92.4%; the lower bound of the 95% CI was 90.2% which exceeded the PG of 83.4% (P<0.0001). Mean calcified segment length was 47.9±18.8 mm, calcium angle was 292.5±76.5° and calcium thickness was 0.96±0.25 mm at the site of maximum calcification. OCT demonstrated multi-plane and longitudinal calcium fractures after IVL in 67.4% of lesions. Minimum stent area was 6.5 ± 2.1mm and was similar regardless of demonstrable fractures on OCT.
Conclusions
Coronary IVL safely and effectively facilitated stent implantation in severely calcified lesions.

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

J Am Coll Cardiol: 09 Oct 2020; epub ahead of print

Ticagrelor alone vs. ticagrelor plus aspirin following percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndromes: TWILIGHT-ACS.

Baber U, Dangas G, Angiolillo DJ, Cohen DJ, ... Gibson CM, Mehran R
Aims 
The aim of this study was to determine the effect of ticagrelor monotherapy on clinically relevant bleeding and major ischaemic events in relation to clinical presentation with and without non-ST elevation acute coronary syndromes (NSTE-ACS) among patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES).
Methods and results 
We conducted a pre-specified subgroup analysis of The Ticagrelor With Aspirin or Alone in High Risk Patients After Coronary Intervention (TWILIGHT) trial, which enrolled 9006 patients with high-risk features undergoing PCI with DES. After 3 months of dual antiplatelet therapy (DAPT) with ticagrelor plus aspirin, 7119 adherent and event-free patients were randomized in a double-blind manner to ticagrelor plus placebo versus ticagrelor plus aspirin for 12 months. The primary outcome was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding while the composite of all-cause death, myocardial infarction (MI), or stroke was the key secondary outcome. Among patients with NSTE-ACS (n = 4614), ticagrelor monotherapy reduced BARC 2, 3, or 5 bleeding by 53% [3.6% vs. 7.6%; hazard ratio (HR) 0.47; 95% confidence interval (CI) 0.36-0.61; P < 0.001) and in stable patients (n = 2503) by 24% (4.8% vs. 6.2%; HR 0.76; 95% CI 0.54-1.06; P = 0.11; nominal Pint = 0.03). Rates of all-cause death, MI, or stroke among those with (4.3% vs. 4.4%; HR 0.97; 95% CI 0.74-1.28; P = 0.84) and without (3.1% vs. 3.2%; HR 0.96; 95% CI 0.61-1.49; P = 0.85) NSTE-ACS were similar between treatment arms irrespective of clinical presentation (Pint = 0.96).
Conclusion 
Among patients with or without NSTE-ACS who have completed an initial 3-month course of DAPT following PCI with DES, ticagrelor monotherapy reduced clinically meaningful bleeding events without increasing ischaemic risk as compared with ticagrelor plus aspirin. The benefits of ticagrelor monotherapy with respect to bleeding events were more pronounced in patients with NSTE-ACS.
Trial registration
Clinicaltrials.gov identifier: NCT02270242.

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: 30 Sep 2020; 41:3533-3545

A Randomized Pilot Clinical Trial of Early Coronary Angiography Versus No Early Coronary Angiography for Post-Cardiac Arrest Patients Without ST-Segment Elevation: The PEARL Study.

Kern KB, Radsel P, Jentzer JC, Seder DB, ... Hsu CH, Noc M

The benefit of emergent coronary angiography after resuscitation from out-of-hospital cardiac arrest (OHCA) is uncertain for patients without ST-segment elevation (STE). The aim of this randomized trial was to evaluate the efficacy and safety of early coronary angiography and to determine the prevalence of acute coronary occlusion in resuscitated OHCA patients without STE.Adult (>18 years) comatose survivors without STE after resuscitation from OHCA were prospectively randomized in a 1:1 fashion under exception to informed consent regulations to early coronary angiography versus no early coronary angiography in this multi-center study. Early angiography was defined as ≤ 120 minutes from arrival at the percutaneous coronary intervention capable facility. The primary endpoint was a composite of efficacy and safety measures, including efficacy parameters of survival to discharge, favorable neurological status at discharge (Cerebral Performance Category ≤ 2), echocardiographic measures of left ventricular ejection fraction >50% and a normal regional wall motion score of 16 within 24 hours of admission. Adverse events included re-arrest, pulmonary edema on chest x-ray, acute renal dysfunction, bleeding requiring transfusion or intervention, hypotension (systolic arterial pressure ≤90 mmHg), and pneumonia. Secondary endpoints included the incidence of culprit vessels with acute occlusion.The study was prematurely terminated before enrolling the target number of patients. A total of 99 patients were enrolled from 2015-2018, including 75 with initially shockable rhythms. Forty-nine patients were randomized to early coronary angiography. The primary endpoint of efficacy and safety was not different between the two groups (55.1% vs 46.0%; p=0.64). Early coronary angiography was not associated with any significant increase in survival (55.1% vs 48.0%; p=0.55 or adverse events (26.5% vs 26.0%; p=1.00). Early coronary angiography revealed a culprit vessel in 47%, with a total of 14% of patients undergoing early coronary angiography having an acutely occluded culprit coronary artery.This underpowered study, when considered together with previous clinical trials, does not support early coronary angiography for comatose survivors of cardiac arrest without ST elevation. Whether early detection of occluded potential culprit arteries leads to interventions that improve outcomes requires additional study.URL: https://www.clinicaltrials.gov. Unique identifier: NCT02387398.



Circulation: 27 Sep 2020; epub ahead of print

Postoperative Atrial Fibrillation and Long-Term Risk of Stroke After Isolated Coronary Artery Bypass Graft Surgery.

Benedetto U, Gaudino MF, Dimagli A, Gerry S, ... Taggart DP,
Background
Postoperative atrial fibrillation (pAF) after coronary artery bypass grafting is a common complication. Whether pAF is associated with an increased risk of cerebrovascular accident (CVA) remains uncertain. We investigated the association between pAF and long-term risk of CVA by performing a post hoc analysis of 10-year outcomes of the ART (Arterial Revascularization Trial).
Methods
For the present analysis, among patients enrolled in the ART (n=3102), we excluded those who did not undergo surgery (n=25), had a history of atrial fibrillation (n=45), or had no information on the incidence of pAF (n=9). The final population consisted of 3023 patients, of whom 734 (24.3%) developed pAF with the remaining 2289 maintaining sinus rhythm. Competing risk and Cox regression analyses were used to investigate the association between pAF and the risk of CVA.
Results
At 10 years, the cumulative incidence of CVA was 6.3% (4.6%-8.1%) versus 3.7% (2.9%-4.5%) in patients with pAF and sinus rhythm, respectively. pAF was an independent predictor of CVA at 10 years (hazard ratio, 1.53 [95% CI, 1.06-2.23]; =0.025) even when CVAs that occurred during the index admission were excluded from the analysis (hazard ratio, 1.47 [95% 1.02-2.11]; =0.04).
Conclusions
Patients with pAF after coronary artery bypass grafting are at higher risk of CVA. These findings challenge the notion that pAF is a benign complication.



Circulation: 05 Oct 2020; 142:1320-1329

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

Tamburino C, Bleiziffer S, Thiele H, Scholtz S, ... Hengstenberg C, Capodanno D

There are few randomized trials comparing bioprostheses for transcatheter aortic valve replacement (TAVR), and no trials compared TAVR bioprostheses with supra-annular design. The SCOPE 2 trial was designed to compare the clinical outcomes of the ACURATE neo and CoreValve Evolut valves.SCOPE 2 was a randomized trial performed at 23 centers in 6 countries between April 2017 and April 2019. Patients ≥75 years with an indication for transfemoral TAVR 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 endpoint, powered for non-inferiority of the ACURATE neo valve, was all-cause death or stroke at 1 year. The key secondary endpoint, powered for superiority of the ACURATE neo valve, was new permanent pacemaker implantation at 30 days.Among 796 randomized patients (mean age 83.2±4.3 years; mean STS-PROM score 4.6± 2.9%), clinical follow-up information was available for 778 (98%) patients. Within 1 year, the primary endpoint 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 one-sided 95% confidence limit 6.1%, p=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% confidence interval -12.4 to -2.60, p=0.0027). No significant differences were observed in the components of the primary endpoint. Cardiac death at 30 days (2.8% vs. 0.8%, p=0.03) and 1 year (8.4% vs. 3.9%, p=0.01), and moderate or severe aortic regurgitation at 30 days (10% vs. 3%, p=0.002) were significantly increased in the ACURATE neo group.Transfemoral TAVR with the self-expanding ACURATE neo did not meet non-inferiority compared to the self-expanding CoreValve Evolut in terms of all-cause death or stroke at 1 year, and 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.URL: https://clinicaltrials.gov/ Unique Identifier: NCT03192813.



Circulation: 14 Oct 2020; epub ahead of print

PAR1 (Protease-Activated Receptor 1) Pepducin Therapy Targeting Myocardial Necrosis in Coronary Artery Disease and Acute Coronary Syndrome Patients Undergoing Cardiac Catheterization: A Randomized, Placebo-Controlled, Phase 2 Study.

Kuliopulos A, Gurbel PA, Rade JJ, Kimmelstiel CD, ... Covic L,
Objective
Arterial thrombosis leading to ischemic injury worsens the prognosis of many patients with cardiovascular disease. PZ-128 is a first-in-class pepducin that reversibly inhibits PAR1 (protease-activated receptor 1) on platelets and other vascular cells by targeting the intracellular surface of the receptor. The TRIP-PCI (Thrombin Receptor Inhibitory Pepducin in Percutaneous Coronary Intervention) trial was conducted to assess the safety and efficacy of PZ-128 in patients undergoing cardiac catheterization with intent to perform percutaneous coronary intervention. Approach and Results: In this randomized, double-blind, placebo-controlled, phase 2 trial, 100 patients were randomly assigned (2:1) to receive PZ-128 (0.3 or 0.5 mg/kg), or placebo in a 2-hour infusion initiated just before the start of cardiac catheterization, on top of standard oral antiplatelet therapy. Rates of the primary end point of bleeding were not different between the combined PZ-128 doses (1.6%, 1/62) and placebo group (0%, 0/35). The secondary end points of major adverse coronary events at 30 and 90 days did not significantly differ but were numerically lower in the PZ-128 groups (0% and 2% in the PZ-128 groups, 6% and 6% with placebo, p=0.13, p=0.29, respectively). In the subgroup of patients with elevated baseline cardiac troponin I, the exploratory end point of 30-day major adverse coronary events + myocardial injury showed 83% events in the placebo group versus 31% events in the combined PZ-128 drug groups, an adjusted relative risk of 0.14 (95% CI, 0.02-0.75); =0.02.
Conclusions
In this first-in-patient experience, PZ-128 added to standard antiplatelet therapy appeared to be safe, well tolerated, and potentially reduced periprocedural myonecrosis, thus providing the basis for further clinical trials.
Registration
URL: https://www.clinicaltrials.gov. Unique identifier: NCT02561000.



Arterioscler Thromb Vasc Biol: 07 Oct 2020:ATVBAHA120315168; epub ahead of print

Coronary Vascular Function and Cardiomyocyte Injury: A Report WISE-CVD.

AlBadri A, Wei J, Quesada O, Mehta PK, ... Pepine CJ, Bairey Merz CN
Objective
Women with symptoms or signs of myocardial ischemia but no obstructive coronary artery disease (INOCA) often have coronary vascular dysfunction and elevated risk for adverse cardiovascular events. We hypothesized that u-hscTnI (ultra-high-sensitivity cardiac troponin I), a sensitive indicator of ischemic cardiomyocyte injury, is associated with coronary vascular dysfunction in women with INOCA. Approach and Results: Women (N=263) with INOCA enrolled in the WISE-CVD study (Women\'s Ischemic Syndrome Evaluation-Coronary Vascular Dysfunction) underwent invasive coronary vascular function testing and u-hscTnI measurements (Simoa HD-1 Analyzer; Quanterix Corporation, Lexington, MA). Logistic regression models, adjusted for traditional cardiovascular risk factors were used to evaluate associations between u-hscTnI and coronary vascular function. Women with coronary vascular dysfunction (microvascular constriction and limited coronary epicardial dilation) had higher plasma u-hscTnI levels (both =0.001). u-hscTnI levels were associated with microvascular constriction (odds ratio, 1.38 per doubling of u-hscTnI [95% CI, 1.03-1.84]; =0.033) and limited coronary epicardial dilation (odds ratio, 1.37 per doubling of u-hscTnI [95% CI, 1.04-1.81]; =0.026). u-hscTnI levels were not associated with microvascular dilation or coronary epicardial constriction.
Conclusions
Our findings indicate that higher u-hscTnI is associated with coronary vascular dysfunction in women with INOCA. This suggests that ischemic cardiomyocyte injury in the setting of coronary vascular dysfunction has the potential to contribute to adverse cardiovascular outcomes observed in these women. Additional studies are needed to confirm and investigate mechanisms underlying these findings in INOCA.
Registration
URL: https://www.clinicaltrials.gov; Unique identifier: NCT00832702.



Arterioscler Thromb Vasc Biol: 07 Oct 2020:ATVBAHA120314260; epub ahead of print

Sleep apnoea and cardiovascular outcomes after coronary artery bypass grafting.

Koo CY, Aung AT, Chen Z, Kristanto W, ... Kofidis T, Lee CH
Objective
Patients with advanced coronary artery disease are referred for coronary artery bypass grafting (CABG) and it remains unknown if sleep apnoea is a risk marker. We evaluated the association between sleep apnoea and major adverse cardiac and cerebrovascular events (MACCE) in patients undergoing non-emergent CABG.
Methods
This was a prospective cohort study conducted between November 2013 and December 2018. Patients from four public hospitals referred to a tertiary cardiac centre for non-emergent CABG were recruited for an overnight sleep study using a wrist-worn Watch-PAT 200 device prior to CABG.
Results
Among the 1007 patients who completed the study, sleep apnoea (defined as apnoea-hypopnoea index ≥15 events per hour) was diagnosed in 513 patients (50.9%). Over a mean follow-up period of 2.1 years, 124 patients experienced the four-component MACCE (2-year cumulative incidence estimate, 11.3%). There was a total of 33 cardiac deaths (2.5%), 42 non-fatal myocardial infarctions (3.7%), 50 non-fatal strokes (4.9%) and 36 unplanned revascularisations (3.2%). The crude incidence of MACCE was higher in the sleep apnoea group than the non-sleep apnoea group (2-year estimate, 14.7% vs 7.8%; p=0.002). Sleep apnoea predicted the incidence of MACCE in unadjusted Cox regression analysis (HR 1.69; 95% CI 1.18 to 2.43), and remained statistically significant (adjusted HR 1.57; 95% CI 1.09 to 2.25), after adjustment for age, sex, body mass index, left ventricular ejection fraction, diabetes mellitus, hypertension, chronic kidney disease and excessive daytime sleepiness.
Conclusion
Sleep apnoea is independently associated with increased MACCE in patients undergoing CABG.
Trial registration number
NCT02701504.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Heart: 29 Sep 2020; 106:1495-1502

Association between age and readmission after percutaneous coronary intervention for acute myocardial infarction.

Qin Y, Wei X, Han H, Wen Y, ... Tomey MI, He J
Objective
This study aimed to investigate the association between age and the risk of 30-day unplanned readmission among adult patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI).
Methods
This retrospective analysis included patients from the Nationwide Readmissions Database with AMI who underwent PCI during 2013-2014. We used multivariable logistic regression model to calculate adjusted odds ratios (AORs) for risk of readmission. To examine potential non-linear association, we performed logistic regression with restricted cubic splines (RCS).
Results
Of the 492 550 patients with AMI aged above 18 years undergoing PCI during the index hospitalisation, 48 630 (9.87%) were readmitted within 30 days. Although the crude readmission rate of younger patients (aged 18-54 years) was the lowest (7.27%), younger patients had higher risk of readmission compared with patients aged 55-64 years for all-causes (AOR 1.06 (1.01 to 1.11), p=0.0129) and specific causes, such as AMI and chest pain (both cardiac and non-specific) after adjusted for covariates. Patients aged 65-74 years were at lower risk of all-cause readmission. Older patients (age ≥75 years) had higher risk of readmission for heart failure (AOR 1.50 (1.29 to 1.74)) and infection (AOR 1.44 (1.16 to 1.79)), but lower risk for chest pain. RCS analyses showed a U-shaped relationship between age and readmission risk.
Conclusions
Our results suggest higher risk of readmission in younger patients for all-cause unplanned readmission after adjusted for covariates. The trends of readmission risk along with age were different for specific causes. Age-targeted initiatives are warranted to reduce preventable readmissions in patients with AMI undergoing PCI.

© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.

Heart: 29 Sep 2020; 106:1595-1603

Colchicine for acute and chronic coronary syndromes.

Imazio M, Andreis A, Brucato A, Adler Y, De Ferrari GM

Colchicine is an ancient drug, traditionally used for the treatment and prevention of gouty attacks; it has become standard of treatment for pericarditis with a potential role in the treatment of coronary artery disease. Atherosclerotic plaque formation, progression, destabilisation and rupture are influenced by active proinflammatory cytokines interleukin (IL)-1β and IL-18 that are generated in the active forms by inflammasomes, which are cytosolic multiprotein oligomers of the innate immune system responsible for the activation of inflammatory responses. Colchicine has a unique anti-inflammatory mechanism: it is not only able to concentrate in leucocytes, especially neutrophils, and block tubulin polymerisation, affecting the microtubules assembly, but also inhibits (NOD)-like receptor protein 3 (NLRP3) inflammasome. On this basis, colchicine interferes with several functions of leucocytes and the assembly and activation of the inflammasome as well, reducing the production of interleukin 1β and interleukin 18. Long-term use of colchicine has been associated with a reduced rate of cardiovascular events both in chronic and acute coronary syndromes, with an overall good safety profile. This review will focus on the influence of colchicine on the pathophysiology of coronary artery disease, reviewing essential pharmacology and discussing the most important and recent clinical studies. On the basis of current literature, colchicine is emerging as a possible new valuable, safe and cheap agent for the treatment of acute and chronic coronary syndromes.

© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.

Heart: 29 Sep 2020; 106:1555-1560

Incidence and outcome of myocardial infarction treated with percutaneous coronary intervention during COVID-19 pandemic.

Mohammad MA, Koul S, Olivecrona GK, Gӧtberg M, ... James SK, Erlinge D
Objective
Most reports on the declining incidence of myocardial infarction (MI) during the COVID-19 have either been anecdotal, survey results or geographically limited to areas with lockdowns. We examined the incidence of MI during the COVID-19 pandemic in Sweden, which has remained an open society with a different public health approach fighting COVID-19.
Methods
We assessed the incidence rate (IR) as well as the incidence rate ratios (IRRs) of all MI referred for coronary angiography in Sweden using the nationwide Swedish Coronary Angiography and Angioplasty Registry (SCAAR), during the COVID-19 pandemic in Sweden (1 March 2020-7 May 2020) in relation to the same days 2015-2019.
Results
A total of 2443 MIs were referred for coronary angiography during the COVID-19 pandemic resulting in an IR 36 MIs/day (204 MIs/100 000 per year) compared with 15 213 MIs during the reference period with an IR of 45 MIs/day (254 MIs/100 000 per year) resulting in IRR of 0.80, 95% CI (0.74 to 0.86), p<0.001. Results were consistent in all investigated patient subgroups, indicating no change in patient category seeking cardiac care. Kaplan-Meier event rates for 7-day case fatality were 439 (2.3%) compared with 37 (2.9%) (HR: 0.81, 95% CI (0.58 to 1.13), p=0.21). Time to percutaneous coronary intervention (PCI) was shorter during the pandemic and PCI was equally performed, indicating no change in quality of care during the pandemic.
Conclusion
The COVID-19 pandemic has significantly reduced the incidence of MI referred for invasive treatment strategy. No differences in overall short-term case fatality or quality of care indicators were observed.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.

Heart: 05 Oct 2020; epub ahead of print

Angiogenesis After Acute Myocardial Infarction.

Wu X, Reboll MR, Korf-Klingebiel M, Wollert KC

Acute myocardial infarction (MI) inflicts massive injury to the coronary microcirculation leading to vascular disintegration and capillary rarefication in the infarct region. Tissue repair after MI involves a robust angiogenic response that commences in the infarct border zone and extends into the necrotic infarct core. Technological advances in several areas have provided novel mechanistic understanding of postinfarction angiogenesis and how it may be targeted to improve heart function after MI. Cell lineage tracing studies indicate that new capillary structures arise by sprouting angiogenesis from preexisting endothelial cells (ECs) in the infarct border zone with no meaningful contribution from non-endothelial cell sources. Single cell RNA sequencing (scRNAseq) shows that ECs in infarcted hearts may be grouped into clusters with distinct gene expression signatures, likely reflecting functionally distinct cell populations. EC-specific multicolor lineage tracing reveals that EC subsets clonally expand after MI. Expanding EC clones may arise from tissue-resident ECs with stem cell characteristics that have been identified in multiple organs including the heart. Tissue repair after MI involves interactions among multiple cell types which occur, to a large extent, through secreted proteins and their cognate receptors. While we are only beginning to understand the full complexity of this intercellular communication, macrophage and fibroblast populations have emerged as major drivers of the angiogenic response after MI. Animal data support the view that the endogenous angiogenic response after MI can be boosted to reduce scarring and adverse left ventricular remodeling. The improved mechanistic understanding of infarct angiogenesis therefore creates multiple therapeutic opportunities. During preclinical development, all proangiogenic strategies should be tested in animal models that replicate both cardiovascular risk factor(s) and the pharmacotherapy typically prescribed to patients with acute MI. Considering that the majority of patients nowadays do well after MI, clinical translation will require careful selection of patients in need of proangiogenic therapies.

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

Cardiovasc Res: 15 Oct 2020; epub ahead of print

Multiple arterial coronary bypass grafting is associated with greater survival in women.

Tam DY, Rocha RV, Fang J, Ouzounian M, ... Gaudino M, Fremes SE
Objective
Multiple arterial grafting (MAG) in coronary artery bypass grafting (CABG) is associated with higher survival and freedom from major adverse cardiac and cerebrovascular events (MACCEs) in observational studies of mostly men. It is not known whether MAG is beneficial in women. Our objectives were to compare the long-term clinical outcomes of MAG versus single arterial grafting (SAG) in women undergoing CABG for multivessel disease.
Methods
Clinical and administrative databases for Ontario, Canada, were linked to obtain all women with angiographic evidence of left main, triple or double vessel disease undergoing isolated non-emergent primary CABG from 2008 to 2019. 1:1 propensity score matching was performed. Late mortality and MACCE (composite of stroke, myocardial infarction, repeat revascularisation and death) were compared between the matched groups with a stratified log-rank test and Cox proportional-hazards model.
Results
2961 and 7954 women underwent CABG with MAG and SAG, respectively, for multivessel disease. Prior to propensity-score matching, compared with SAG, those who underwent MAG were younger (66.0 vs 68.9 years) and had less comorbidities. After propensity-score matching, in 2446 well-matched pairs, there was no significant difference in 30-day mortality (1.6% vs 1.8%, p=0.43) between MAG and SAG. Over a median and maximum follow-up of 5.0 and 11.0 years, respectively, MAG was associated with greater survival (HR 0.85, 95% CI 0.75 to 0.98) and freedom from MACCE (HR 0.85, 95% CI 0.76 to 0.95).
Conclusions
MAG was associated with greater survival and freedom from MACCE and should be considered for women with good life expectancy requiring CABG.

© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.

Heart: 19 Oct 2020; epub ahead of print

Outcomes of Transcatheter Aortic Valve Replacement with Percutaneous Coronary Intervention versus Surgical Aortic Valve Replacement with Coronary Artery Bypass Grafting.

Abugroun A, Osman M, Awadalla S, Klein L

We aimed to compare the outcomes of combined surgical aortic valve replacement (SAVR) with coronary artery bypass grafting (CABG) to concurrent transcatheter aortic valve replacement (TAVR) with percutaneous coronary intervention (PCI) in a large U.S. population sample. The National Inpatient Sample (NIS) was queried for all patients diagnosed with aortic valve stenosis who underwent SAVR with CABG or TAVR with PCI during the years 2016-2017. Study outcomes included all-cause in-hospital mortality, acute stroke, pacemaker insertion, vascular complications, major bleeding, acute kidney injury, sepsis, non-home discharge, length of stay and cost. Outcomes of hospitalization were modeled using logistic regression for binary outcomes and generalized linear models for continuous outcomes. Overall, 31,205 patients were included (TAVR + PCI=2,185, SAVR + CABG=29,020). In reference to SAVR + CABG, recipients of TAVR + PCI were older with mean age 82 vs 73 years, effect size (d) =0.9, had higher proportions of females 47.6% vs 26.6%, d= 0.4 and higher prevalence of congestive heart failure and chronic renal failure. On multivariable analysis, TAVR + PCI was associated with lowers odds for mortality adjusted OR: 0.32 [95%CI: 0.17 - 0.62] p=0.001, lower odds for acute kidney injury, sepsis, non-home discharge, shorter length of stay and higher odds for vascular complications, need for pacemaker insertion and higher cost. The occurrence of stroke was similar between both groups. In conclusion, results from real-world observational data shows less rates of mortality and periprocedural complications in TAVR + PCI compared to SAVR + CABG.

Copyright © 2020. Published by Elsevier Inc.

Am J Cardiol: 25 Sep 2020; epub ahead of print

Trends in Costs and Risk Factors of 30-Day Readmissions for Transcatheter Aortic Valve Implantation.

Arora S, Hendrickson MJ, Strassle PD, Qamar A, ... Bhatt DL, Vavalle JP

As transcatheter aortic valve implantation (TAVI) continues its rapid growth as a treatment approach for aortic stenosis, costs associated with TAVI and its burden to healthcare systems will assume greater importance. Patients undergoing TAVI between January 2012 and November 2017 in the Nationwide Readmission Database were identified. Trends in cause-specific readmissions were assessed using Poisson regression. Thirty-day TAVI cost burden (cost of index TAVI hospitalization plus total 30-day readmissions cost) was adjusted to 2017 U.S. dollars and trended over year from 2012 to 2017. Overall, 47,255 TAVI were included and 30-day readmissions declined from 20% to 12% (p<0.0001). Most common causes of readmission (heart failure, infection/sepsis, gastrointestinal causes, and respiratory) declined as well, except arrhythmia/heart block which increased (1.0% to 1.4%, p<0.0001). Cost of TAVI hospitalization ($52,024 to $44,110, p<0.0001) and 30-day cost burden ($54,122 to $45,252, p<0.0001) declined. While costs of an average readmission did not change ($9,734 to $10,068, p=0.06), cost burden of readmissions (per every TAVI performed) declined ($4,061 to $1,883, p<0.0001), including reductions in each of the top 5 causes except arrhythmia/heart block ($171 to $263, p=0.04). Index TAVI hospitalizations complicated by acute kidney injury, length of stay ≥5 days, low hospital procedural volume, and skilled nursing facility discharge were associated with increased odds of 30-day readmissions. In conclusion, the costs of index hospitalizations and 30-day cost burden for TAVI in the U.S. significantly declined from 2012-2017. However, readmissions due to arrhythmia/heart block and their associated costs increased. Continued strategies to prevent readmissions, especially those for conduction disturbances, are crucial in the efforts to optimize outcomes and costs with the ongoing expansion of TAVI.

Copyright © 2020. Published by Elsevier Inc.

Am J Cardiol: 25 Sep 2020; epub ahead of print

Outcomes of Patients with Severe Aortic Stenosis and Left Ventricular Obstruction Undergoing Transcatheter Aortic Valve Implantation.

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

Scarce data exist on clinical features and prognosis of patients with severe aortic stenosis (AS), concomitant with left ventricular obstruction (LVO). We aimed to evaluate the prevalence, characteristics, and outcomes in patients with severe AS and LVO undergoing transcatheter aortic valve implantation (TAVI). Consecutive patients with severe AS undergoing TAVI between January 2013 to December 2017 at our institution were included. Significant LVO was defined as resting peak left ventricular (LV) systolic gradient ≥30 mm Hg on pre-TAVI echocardiography. We analyzed the primary composite outcome of all-cause mortality and rehospitalization for heart failure (HHF) at 1-year in patients with LVO and those without LVO in the overall and propensity-matched populations. Among 1,729 patients who underwent TAVI, significant LVO was observed in 31 (1.8%) patients. This group was more likely to be female, had smaller aortic annulus and LV cavity, and received a smaller size of the transcatheter heart valve. The most common phenotype of LV hypertrophy causing LVO was concentric LV hypertrophy (58%), and mid-LV obstruction was more common than LV outflow tract obstruction (77% vs 23%, respectively). After adjustment for baseline differences, the primary outcome was not significantly different between patients with LVO and those without LVO (15% vs 16%, respectively; hazard ratio: 0.83; 95% confidence interval: 0.19 to 3.72; p = 0.809). In conclusion, in patients undergoing TAVI, concomitant LVO was relatively uncommon and occurred more often at mid-LV. The presence of pre-TAVI LVO was not associated with worse outcomes defined as increase all-cause mortality or HHF at 1-year.

Copyright © 2020 Elsevier Inc. All rights reserved.

Am J Cardiol: 14 Oct 2020; 133:105-115

Long-Term Outcomes of Acute Myocardial Infarction With Concomitant Cardiogenic Shock and Cardiac Arrest.

Vallabhajosyula S, Payne SR, Jentzer JC, Sangaralingham LR, ... Prasad A, Dunlay SM

This study sought to evaluate long-term mortality and major adverse cardiac and cerebrovascular events (MACCE) in patients with cardiac arrest (CA) and cardiogenic shock (CS) complicating acute myocardial infarction (AMI). This was a retrospective cohort study using an administrative claims database. AMI patients from January 1, 2010 to May 31, 2018 were stratified into CA + CS, CA only, CS only, and AMI alone cohorts. Outcomes of interest were long-term mortality and MACCE (death, AMI, cerebrovascular accident, unplanned revascularization) in AMI survivors. A total 163,071 AMI patients were included with CA + CS, CA only, and CS only in 2.4%, 5.0%, and 4.0%, respectively. The CA + CS cohort had higher rates of multiorgan failure, mechanical circulatory support use and less frequent coronary angiography use. In-hospital mortality was noted in 10,686 (6.6%) patients - CA + CS (48.8%), CA only (35.9%), CS only (24.1%), and AMI alone (2.9%; p < 0.001). Over 23.5 ± 21.7 months follow-up after hospital discharge, patients with CA + CS (hazard ratio [HR] 1.36 [95% confidence interval {CI} 1.19 to 1.55]), CA only (HR 1.16 [95% CI 1.08 to 1.25]), CS only (HR 1.39 [95% CI 1.29 to 1.50]) had higher all-cause mortality compared with AMI alone (all p < 0.001). Presence of CS, either alone (HR 1.22 [95% CI 1.16 to 1.29]; p < 0.001) or with CA (HR 1.18 [95% CI 1.07 to 1.29]; p < 0.001), was associated with higher MACCE compared with AMI alone. In conclusion, CA + CS, CA, and CS were associated with worse long-term survival. CA and CS continue to influence outcomes beyond the index hospitalization in AMI survivors.

Copyright © 2020 Elsevier Inc. All rights reserved.

Am J Cardiol: 14 Oct 2020; 133:15-22

Prediction of 1-Year Mortality from Acute Myocardial Infarction Using Machine Learning.

Lee HC, Park JS, Choe JC, Ahn JH, ... Jeong MH,

Risk stratification at hospital discharge could be instrumental in guiding postdischarge care. In this study, the risk models for 1-year mortality using machine learning (ML) were evaluated for guiding management of acute myocardial infarction (AMI) patients. From the Korea Acute Myocardial Infarction Registry (KAMIR) dataset, 22,182 AMI patients were selected. The 1-year all-cause mortality was recorded at 12-month follow-up periods. Anomaly detection was conducted for removing outliers; principal component analysis for dimensionality reduction, recursive feature elimination algorithm for feature selection. Model selection and training were conducted with 70% of the dataset after the creation and cross-validation of hundreds of models with decision trees, ensembles, logistic regressions, and deepnets algorithms. The rest of the dataset (30%) was used for comparison between the ML and KAMIR score-based models. The mean age of the AMI patients was 64 years, 71.8% were male, and 56.7% were eventually diagnosed with ST-elevation myocardial infarction. There were 1,332 patients suffering from all-cause mortality (6%) during a median 338 days of follow-up. The ML models for 1-year mortality were well-calibrated (Hosmer-Lemeshow p >0.05) and showed good discrimination (area under the curve for test cohort: 0.918). Compared with the performance of the KAMIR score model, the ML model had a higher area under the curve, net reclassification improvement, and integrated discrimination improvement. The ML model for 1-year mortality was well-calibrated and had excellent discriminatory ability and higher performance. In a comprehensive clinical evaluation process, this model could support risk stratification and management in postdischarge AMI patients.

Copyright © 2020 Elsevier Inc. All rights reserved.

Am J Cardiol: 14 Oct 2020; 133:23-31

Temporal Trends and Outcomes of Left Ventricular Aneurysm After Acute Myocardial Infarction.

Vallabhajosyula S, Kanwar S, Aung H, Cheungpasitporn W, ... Gulati R, Singh M

There are limited data on the prevalence and an outcome of left ventricular (LV) aneurysms following acute myocardial infarction (AMI). Using the National Inpatient Sample during 2000 to 2017, a retrospective cohort of AMI admissions was evaluated for LV aneurysms. Complications included ventricular arrhythmias, mechanical, cardiac arrest, pump failure, LV thrombus, and stroke. Outcomes of interest included in-hospital mortality, temporal trends, complications, hospitalization costs, and length of stay. A total 11,622,528 AMI admissions, with 17,626 (0.2%) having LV aneurysms were included. The LV aneurysm cohort was more often female, with higher comorbidity, and admitted to large urban hospitals (all p < 0.001). In 2017, compared with 2000, there was a slight increase in LV aneurysms prevalence in those with (adjusted odds ratio [aOR] 1.57 [95% confidence interval {CI} 1.41 to 1.76]) and without (aOR 1.13 [95% CI 1.00 to .127]) ST-segment-elevation AMI (p < 0.001 for trend). LV aneurysms were more commonly noted with anterior ST-segment-elevation AMI (31%) compared with inferior (12.3%) and other (7.9%). Ventricular arrhythmias (17.6% vs 8.0%), mechanical complications (2.6% vs 0.2%), cardiac arrest (7.1% vs 5.0%), pump failure (26.3% vs 16.1%), cardiogenic shock (10.0% vs 4.8%) were more common in the LV aneurysm cohort (all p < 0.001). Those with LV aneurysms had comparable in-hospital mortality compared with those without (7.4% vs 6.2%; aOR 1.02 [95% CI 0.90 to 1.14]; p = 0.43). The LV aneurysm cohort had longer length of hospital stay, higher hospitalization costs, and fewer discharges to home. In conclusion, LV aneurysms were associated with higher morbidity, more frequent complications, and greater in-hospital resource utilization, without any differences in in-hospital mortality in AMI.

Copyright © 2020 Elsevier Inc. All rights reserved.

Am J Cardiol: 14 Oct 2020; 133:32-38

Late Adverse Cardiorenal Events of Catheter Procedure-Related Acute Kidney Injury After Transcatheter Aortic Valve Implantation.

Adachi Y, Yamamoto M, Shimura T, Yamaguchi R, ... Hayashida K,

Data regarding the longitudinal effect of catheter procedure-related acute kidney injury (AKI) on clinical outcomes are limited. This study aimed to assess the late adverse cardiorenal events of AKI following transcatheter aortic valve implantation (TAVI). A total of 2,518 patients who underwent TAVI, excluding in-hospital deaths, were enrolled from the Japanese multicenter registry. The definition of AKI was determined using the Valve Academic Research Consortium-2 criteria. The incidence, predictors, major adverse renal and cardiac events (MARCE), and all-cause mortality of AKI were evaluated. MARCE included readmission for renal and heart failure (HF), hemodialysis requirement, and cardiovascular-renal death during the follow-up period. The incidence of AKI was 9.7% in the entire cohort. The significant predictive factors of AKI were men, diabetes mellitus, hypertension, chronic kidney disease, low albumin, overdose of contrast media, nontransfemoral approach, transfusion, vascular complications, and new pacemaker implantation. The rates of HF readmission and future hemodialysis were significantly higher in patients with AKI than in those without AKI (19.7% vs 9.0%, p <0.001, 3.3% vs 0.4%, p <0.001, respectively). Cox regression multivariate analysis showed that AKI occurrence was an independent predictive factor for the incremental risk of both MARCE and late mortality up to 4 years (hazard ratio [HR] 1.59, 95% confidence interval [CI] 0.75 to 1.20, p <0.001, HR 2.18, 95% CI 1.70 to 2.79; p <0.001, respectively). In conclusion, AKI occurrence was significantly associated with late adverse cardiorenal events after TAVI. Adequate clinical management can be expected to reduce AKI-related late phase cardiorenal damage even after successful TAVI.

Copyright © 2020 Elsevier Inc. All rights reserved.

Am J Cardiol: 14 Oct 2020; 133:89-97

Relation of Proprotein Convertase Subtilisin/Kexin Type 9 to Cardiovascular Outcomes in Patients Undergoing Percutaneous Coronary Intervention.

Choi IJ, Lim S, Lee D, Lee WJ, ... Kim MJ, Jeon DS

The pharmacological inhibition of proprotein convertase subtilisin/kexin type 9 (PCSK9) has been shown to drastically affect low-density lipoprotein cholesterol levels and associated cardiovascular diseases. However, the potential effectiveness of PCSK9 serum levels as a biomarker for cardiovascular risk remains unclear. Serum PCSK9 levels in patients who underwent percutaneous coronary intervention (PCI) may predict long-term outcomes. PCSK9 levels were measured in 749 consecutive patients with coronary artery disease undergoing PCI. These patients were classified into 2 groups according to their serum levels of PCSK9. The primary end point was a composite of the major adverse cardiac events (MACE), including cardiac death, myocardial infarction, stroke, and any revascularization. The median PCSK9 level was 302.82 ng/ml. During a median follow-up of 28.4 months, a total of 38 (5.1%) MACE was recorded, and 50 (6.7%) patients died from any cause. Multivariate Cox regression analysis showed that compared with a lower serum PCSK9 level, a higher serum PCSK9 level was independently associated with a higher rate of MACE (adjusted hazard ratio 2.290, 95% confidence interval 1.040 to 5.045, p = 0.040) and all-cause death (adjusted hazard ratio 2.511, 95% confidence interval 1.220 to 5.167, p = 0.026). Results were consistent after propensity-score matching (MACE, adjusted HR 2.236, 95% CI 1.011-5.350, p = 0.047; all-cause death, adjusted HR 2.826, 95% CI 1.258-6.349, p = 0.012). Baseline serum PCSK9 levels were associated with long-term cardiovascular clinical outcomes and mortality during the long-term follow-up after PCI in patients with coronary artery disease.

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Am J Cardiol: 14 Oct 2020; 133:54-60

Cardiac Injury Patterns and Inpatient Outcomes Among Patients Admitted With COVID-19.

Raad M, Dabbagh M, Gorgis S, Yan J, ... McCord J, Parikh S

Although certain risk factors have been associated with increased morbidity and mortality in patients admitted with Coronavirus Disease 2019 (COVID-19), the impact of cardiac injury and high-sensitivity troponin-I (hs-cTnI) concentrations are not well described. In this large retrospective longitudinal cohort study, we analyzed the cases of 1,044 consecutively admitted patients with COVID-19 from March 9 until April 15. Cardiac injury was defined by hs-cTnI concentration >99th percentile. Patient characteristics, laboratory data, and outcomes were described in patients with cardiac injury and different hs-cTnI cut-offs. The primary outcome was mortality, and the secondary outcomes were length of stay, need for intensive care unit care or mechanical ventilation, and their different composites. The final analyzed cohort included 1,020 patients. The median age was 63 years, 511 (50% patients were female, and 403 (40% were white. 390 (38%) patients had cardiac injury on presentation. These patients were older (median age 70 years), had a higher cardiovascular disease burden, in addition to higher serum concentrations of inflammatory markers. They also exhibited an increased risk for our primary and secondary outcomes, with the risk increasing with higher hs-cTnI concentrations. Peak hs-cTnI concentrations continued to be significantly associated with mortality after a multivariate regression controlling for comorbid conditions, inflammatory markers, acute kidney injury, and acute respiratory distress syndrome. Within the same multivariate regression model, presenting hs-cTnI concentrations were not significantly associated with outcomes, and undetectable hs-cTnI concentrations on presentation did not completely rule out the risk for mechanical ventilation or death. In conclusion, cardiac injury was common in patients admitted with COVID-19. The extent of cardiac injury and peak hs-cTnI concentrations were associated with worse outcomes.

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Am J Cardiol: 14 Oct 2020; 133:154-161

Risk for Recurrent Cardiovascular Events and Expected Risk Reduction With Optimal Treatment 1 Year After an Acute Coronary Syndrome.

Zafeiropoulos S, Farmakis I, Kartas A, Arvanitaki A, ... Karvounis H, Giannakoulas G

According to the latest European Society of Cardiology Guidelines for the diagnosis and management of chronic coronary syndromes, patients who suffered an acute coronary syndrome fall into a chronic stable phase after 1 year. In these patients, the estimated 10-year risk for recurrent cardiovascular events varies considerably. We applied the SMART (Second Manifestations of Arterial Disease) risk score in 281 patients 1 year after an acute coronary syndrome to estimate the 10-year risk for recurrent cardiovascular events (subsequent nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death). We assessed the distribution of the estimated risk and the potential risk reduction that might be achieved with optimal guideline-directed management of modifiable risk factors (systolic blood pressure, low-density lipoprotein cholesterol, smoking, and body mass index). In our cohort, the median SMART score was 16.1% (interquartile range [IQR] 9.7 to 27.3), particularly increased in patients with older age, diabetes, polyvascular disease or chronic kidney disease (median 28.6%, IQR 20.8 to 52.9; 23.8%, 4.8 to 41.6; 29.4%, 18.8 to 49.7; 53.8%, 26.5 to 71.6, respectively). If all modifiable risk factors met guideline-recommended targets, the median SMART risk score would be 9.6% (IQR 6.3 to 20.9), with 51% of the patients at a 10-year risk <10%, while 11% and 15% at 20% to 30% and >30% risk, respectively. In conclusion, the SMART score had a wide distribution in patients with chronic coronary syndromes. A quarter of patients remained at a >20% 10-year risk, even with optimal risk factor management, clearly underlining that residual risk is an unmet clinical challenge.

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Am J Cardiol: 14 Oct 2020; 133:7-14

Risk/Benefit Tradeoff of Prolonging Dual Antiplatelet Therapy More Than 12 Months in TWILIGHT-Like High-Risk Patients After Complex Percutaneous Coronary Intervention.

Wang HY, Dou KF, Yin D, Xu B, Zhang D, Gao RL

Patients who underwent complex percutaneous coronary intervention (PCI) are known to be at high risk for both ischemic and bleeding complications. The risk/benefit tradeoff of extending dual antiplatelet therapy (DAPT) >12 months with clopidogrel and aspirin for TWILIGHT-like patients who are at high risk of bleeding or ischemic events and undergo complex PCI is unclear. Eight thousand three hundred and fifty-eight consecutive patients fulfilling the \"TWILIGHT-like\" criteria who underwent PCI from January 2013 to December 2013 were prospectively enrolled in Fuwai PCI Registry. We identified 2,677 of \"TWILIGHT-like\" complex PCI patients who were events free at 1 year after the index procedure. \"TWILIGHT-like\" patients were identified based on at least 1 clinical and 1 angiographic feature. Median follow-up was 29 months. Risk of primary efficacy outcome, major adverse cardiac and cerebrovascular events (composite of all-cause death, myocardial infarction, or stroke), was reduced with DAPT >12 months versus DAPT≤ 12 months (hazard ratio [HR] 0.374, 95% confidence interval [CI] 0.235 to 0.595; HR 0.292 [0.151 to 0.561]; HR 0.356 [0.225 to 0.562]), with directional consistency for cardiovascular death and definite/probable stent thrombosis. In contrast, >12-month DAPT was comparable to ≤12-month DAPT for the risk of clinically relevant bleeding ([HR] 1.189, 95% CI 0.474 to 2.984; HR 1.577 [0.577 to 4.312]; HR 1.239 [0.502 to 3.059]). Importantly, there was also a significant net benefit in favor of prolonged DAPT treatment. In conclusion, among \"TWILIGHT-like\" patients after complex PCI, continuing duration of DAPT> 12 months was associated with a net clinical benefit and lower rates of ischemic events without increasing the risk of clinically relevant bleeding than DAPT≤ 12 months, suggesting that long-term DAPT may have a favorable risk-benefit ratio in this high-risk population.

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Am J Cardiol: 14 Oct 2020; 133:61-70

Meta-Analysis Comparing the Safety and Efficacy of Prasugrel and Ticagrelor in Acute Coronary Syndrome.

Ullah W, Ali Z, Sadiq U, Rafiq A, ... Sabouret P, Fischman DL

Prasugrel and ticagrelor are preferred over clopidogrel for patients with acute coronary syndrome who underwent percutaneous coronary intervention. We sought to determine the relative merits of 1 agent over the other. Multiple databases were queried to identify relevant randomized control trials (RCTs) and observational cohort studies. Random-effects model was used to calculate an unadjusted odds ratio (OR) for major adverse cardiovascular and cerbrovascular events (MACCE) and its components. A total of 27 (7 RCTs, 20 observational cohort studies) studies comprising 118,266 (prasugrel 62,716, ticagrelor 51,196) patients were included. At 30 days, prasugrel was associated with a significantly lower odds of MACCE (OR 0.75, 95% confidence interval [CI] 0.67 to 0.85, p ≤0.0001) and mortality (OR 0.65, 95% CI 0.59 to 0.71, p ≤0.0001). At 1 year, the overall odds of mortality favored prasugrel (OR 0.79, 95% CI 0.68 to 0.92, p = 0.002), but no significant interdrug difference was seen in terms of MACCE (OR 0.89, 95% CI 0.76 to 1.05, p = 0.16). There was no significant difference in the odds of overall myocardial infarction, revascularization, stent thrombosis, stroke, and major bleeding events between the 2 groups on both 30-day and 1-year follow-up. A subgroup analysis of RCTs data showed no significant difference between prasugrel and ticagrelor in terms of any end point at all time points. In conclusion, prasugrel might have lower odds of MACCE and mortality at 30 days. However, there was no difference in the safety and efficacy end points of 2 drugs at 1 year. The observed transient prasugrel-related mortality benefits were subject to the bias of nonrandomized assignment.

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Am J Cardiol: 30 Sep 2020; 132:22-28

Meta-analysis of Incidence, Predictors and Consequences of Clinical and Subclinical Bioprosthetic Leaflet Thrombosis After Transcatheter Aortic Valve Implantation.

Sannino A, Hahn RT, Leipsic J, Mack MJ, Grayburn PA

Leaflet thrombosis (LT) has been claimed as a potential cause of hemodynamic dysfunction or bioprosthetic valve degeneration of transcatheter heart valves. Sparse and contrasting evidence exists, however, regarding LT occurrence, prevention and treatment. MEDLINE, ISI Web of Science and SCOPUS databases were searched for studies published up to January 2020. Only studies reporting data on incidence and outcomes associated to the presence/absence of clinical or subclinical LT, detected or confirmed with a multidetector computed tomography exam were included. The study was designed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) requirements. Two reviewers independently screened articles for fulfillment of inclusion criteria. Data were pooled using a random-effect model. The primary end point was the incidence of LT. Secondary outcomes included: stroke and transient ischemic attacks and mean transvalvular gradients at different time-points in patients with and without LT. Of the initial 200 studies, 22 were finally included with a total of 11,567 patients. LT overall incidence was 8% (95% Confidence Interval [CI]: 5% to 13%, I = 96.4%). LT incidence in patients receiving only antiplatelets was 13% (95% CI: 7% to 23%, p <0.0001); patients discharged on oral anticoagulants had a reported incidence of 4% (95% CI: 2% to 8%, p <0.0001). Patients with LT, either clinical or subclinical, were not at increased risk of stroke (OR 1.06, 95% CI: 0.75 to 1.50, p = 0.730, I = 0.0%) or transient ischemic attacks (Odds Ratio 1.01, 95% CI: 0.40 to 2.57, p = 0.989, I = 0.0%). LT was associated with higher mean transvalvular gradients compared with patients without LT at 30 days post-transcatheter implantation, but not at discharge or at 1 year. LT is a relatively common event that, even when clinically manifest, is not associated with an increased risk of cerebrovascular events. Although patients on anticoagulants appear to be at lower risk of LT, the available evidence does not allow formulation of recommendations for prophylactical anticoagulation nor routine computed tomography after transcatheter aortic valve replacement.

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Am J Cardiol: 30 Sep 2020; 132:106-113

Comparison of Outcomes of Coronary Revascularization for Acute Myocardial Infarction in Men Versus Women.

Mahowald MK, Alqahtani F, Alkhouli M

This study sought to examine the differences in the characteristics and outcomes between men and women who underwent percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for acute myocardial infarction (AMI) in contemporary US practice. The Nationwide Inpatient Sample was used to identify patients who underwent revascularization for AMI between January 1, 2003 and December 31, 2016. The primary outcome was in-hospital mortality. Propensity score matching was utilized to account for differences in baseline characteristics. In total, 3,603,142 patients were included, of whom only 1,180,436 (33%) were women. Compared with men, women were older and had higher prevalence of key co-morbidities including diabetes, hypertension, congestive heart failure, and chronic kidney and lung disease (p <0.001). In the PCI cohort, women were significantly less likely to undergo multivessel PCI, to receive mechanical circulatory support, or to undergo atherectomy. In the CABG group, women were more likely to have concomitant valve surgery. In the propensity-matched cohorts, in-hospital mortality was higher for women than men regardless of revascularization strategy: 7.6% versus 6.6% for PCI in ST-elevation myocardial infarction, 2.0% versus 1.9% for PCI in non-ST-elevation myocardial infarction, and 5.7% versus 4.3% for CABG in any AMI (p <0.001). Women also had higher rates of major complications, longer hospitalizations, higher costs, and were less likely to be discharged home (vs nursing facility). These sex-based differences persisted over the study 14-year period. In conclusion, in a contemporary nationwide analysis of propensity score-matched patients, women who undergo revascularization for AMI have worse in-hospital outcomes than men regardless of revascularization mode.

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Am J Cardiol: 30 Sep 2020; 132:1-7

Five-Meter Walk Test as a Predictor of Prolonged Index Hospitalization After Transcatheter Aortic Valve Implantation.

Koh JQS, Mohamed Rahim NB, Sng EL, Yap J, ... Chao V, Ho KW

There are no studies evaluating comprehensive predictors of transcatheter aortic valve implantation (TAVI) outcomes encompassing frailty assessments in a South-East Asian cohort. In this longitudinal single-center cohort, all patients who underwent TAVI in a tertiary cardiac center and comprehensively assessed for frailty at baseline were included in a registry. The primary outcome was to investigate frailty indices predictive of prolonged index hospitalization after TAVI. Seventy-six patients with a mean age of 77.6 ± 8.5 years were included. Mean Society of Thoracic Society Predicted Risk of Mortality score was 5.2 ± 3.0, with 11 (14.5%) patients classified as high-risk (Society of Thoracic Society Predicted Risk of Mortality >8). Mean and median index hospitalization duration were 9.2 ± 5.6 and 7 [4.5 to 9.5] days, respectively. Univariate analysis demonstrated that lower hemoglobin (Hb) (p <0.01), longer 5-meter walk test (5MWT) (p <0.01), lower dominant hand grip strength (p <0.01), the use of transaortic access (p = 0.01), new atrial fibrillation post-TAVI (p <0.01), and lower postprocedural Hb (p <0.01) were associated with longer index hospitalization duration. Multivariate linear regression demonstrated preoperative Hb, preoperative atrial fibrillation and 5MWT were independent baseline predictors of index hospitalization duration (p <0.05). Additionally, a 5MWT cutoff of 11 seconds (0.45 m/s) had a high specificity (88.6%) in predicting prolonged index hospitalization duration. In conclusion, this is the first comprehensive frailty assessment in a South-East Asian cohort demonstrating 5MWT to be a significant predictor of prolonged index hospitalization. This simple and effective frailty assessment index may be considered to optimize patient selection for TAVI.

Copyright © 2020 Elsevier Inc. All rights reserved.

Am J Cardiol: 30 Sep 2020; 132:100-105

Duration of Dual Antiplatelet Therapy After Percutaneous Coronary Intervention for Chronic Total Occlusion.

Sachdeva A, Hung YY, Solomon MD, McNulty EJ

The optimal duration of dual antiplatelet therapy (DAPT) after treatment of chronic total occlusions (CTO) with percutaneous coronary intervention (PCI) is unknown. We aimed to determine if extended (> 12 months) DAPT was associated with a net clinical benefit. The study population included patients who underwent successful CTO PCI within Kaiser Permanente Northern California between 2009 and 2016. Baseline demographic, clinical, and procedural characteristics were compared for patients on DAPT ≤ versus > 12 months. Clinical outcomes (death, myocardial infarction (MI), and ≥ Academic Research Consortium type 3a bleeding) were compared beginning 12 months after PCI using Cox proportional hazards models. We also adjudicated individual causes of death. 1,069 patients were followed for a median of 3.6 years (Interquartile Range = 2.2 to 5.5) following CTO PCI. Patients on DAPT ≤ 12 months (n = 597, 56%) were more likely to have anemia, end stage renal disease, and previous MI. After adjustment for between group differences, > 12 months of DAPT was associated with lower death or MI (hazard ratio [HR]: 0.66; 95% confidence interval [CI]: 0.47 to 0.93) and lower death (HR: 0.54; 95% CI: 0.36 to 0.82). There were no associations with MI (HR: 0.91; 95% CI: 0.55 to 1.5) or bleeding (HR 1.1; 95% CI: 0.50 to 2.4), but a numerically higher proportion of patients on shorter v. longer DAPT died of a cardiovascular cause (37% vs 20%, p = 0.10). In conclusion, > 12 months of DAPT was associated with lower death or MI, without an increase in bleeding. Prospective studies are needed to evaluate the optimal duration of DAPT in this unique subgroup.

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Am J Cardiol: 30 Sep 2020; 132:44-51

Outcomes of Patients Undergoing Transcatheter Aortic Valve Implantation With Incidentally Discovered Masses on Computed Tomography.

Ghotra AS, Monlezun DJ, Boone D, Jacob R, ... Smalling RW, Dhoble A

Routine preprocedural chest and abdomen computed tomography is done prior to transcatheter aortic valve implantation (TAVI), which, in turn, have led to the discovery of radiographic potentially malignant incidental masses (pMIM). It is largely unknown whether pMIM impact the outcomes of patients undergoing TAVI. In this retrospective cohort study from a single center, 1,081 patients underwent TAVI from 2012 to 2016, who had available computed tomographies, survived the index hospitalization, and also had 1 year follow-up data for review. Machine learning (backward propagation neural network)-augmented multivariable regression for mortality by pMIM was conducted. In this cohort of 1,081 patients, the mean age was 79.1 (± 9.0), 48.8% were females, 16.8% had a history of prior malignancy, and 21.1% had pMIM. One-year mortality for the entire cohort was 12.6%. The most common prior malignancies were prostate, breast, and lymphoma and the most common pMIM were present in the lung, kidneys, and thyroid. In a fully adjusted regression analysis, neither prior malignancy nor pMIM increased mortality odds. However, having both was associated with a higher 1-year mortality (odds ratio 4.02, 95% confidence interval 1.50 to 10.73, p = 0.006). In conclusion, presence of pMIM alone was not associated with an increased 1-year mortality among patients undergoing TAVI. However, the presence of pMIM and a history of prior malignancy was associated with a significant increase in 1-year mortality.

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Am J Cardiol: 30 Sep 2020; 132:114-118

Comparison of Frequency of Vascular Complications With Ultrasound-Guided Versus Fluroscopic Roadmap-Guided Femoral Arterial Access in Patients Who Underwent Transcatheter Aortic Valve Implantation.

Potluri SP, Hamandi M, Basra SS, Shinn KV, ... Holper E, Mack MJ

To compare outcomes of ultrasound guidance (USG) versus fluoroscopy roadmap guidance (FG) angiography for femoral artery access in patients who underwent transfemoral (TF) transcatheter aortic valve implantation (TAVI) to determine whether routine USG use was associated with fewer vascular complications. Vascular complications are the most frequent procedural adverse events associated with TAVI. USG may provide a decreased rate of access site complications during vascular access compared with FG. Patients who underwent TF TAVI between July 2012 and July 2017 were reviewed and outcomes were compared. Vascular complications were categorized by Valve Academic Research Consortium-2 criteria and analyzed by a multivariable logistic regression adjusting for potential confounding risk factors including age, gender, body mass index, peripheral vascular disease, Society of Thoracic Surgeons score and sheath to femoral artery ratio. Of the 612 TAVI patients treated, 380 (63.1%) were performed using USG for access. Routine use of USG began in March 2015 and increased over time. Vascular complications occurred in 63 (10.3%) patients and decreased from 20% to 3.9% during the study period. There were fewer vascular complications with USG versus FG (7.9% vs 14.2%, p = 0.014). After adjusting for potential confounding risk factors that included newer valve systems, smaller sheath sizes and lower risk patients, there was still a 49% reduction in vascular complications with USG (odds ratio 0.51, 95% confidence interval 0.29 to 0.88, p = 0.02). In conclusion, USG for TF TAVI was associated with reduced vascular access site complications compared with FG access even after accounting for potential confounding risk factors and should be considered for routine use for TF TAVI.

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Am J Cardiol: 30 Sep 2020; 132:93-99

Outcomes After First- Versus Second-Generation Drug-Eluting Stent Thrombosis (from the REAL-ST Registry).

Horie K, Kuramitsu S, Shinozaki T, Ohya M, ... Kimura T,

Limited data exist on the comparison of clinical outcomes after first- and second-generation drug-eluting stent (DES) thrombosis. From the Retrospective Multicenter Registry of Stent Thrombosis (ST) After First- and Second-Generation DES Implantation registry, this study evaluated 655 ST patients (first-generation DES thrombosis [G1-ST], n = 342; second-generation DES thrombosis [G2-ST], n = 313). After propensity score matching, the final study population consisted of 159 matched patients. The primary end point was the cumulative 1-year incidence of mortality. The mortality after G2-ST at 1 year was similar to that after G1-ST (23.0% vs 22.9%, p = 0.76). Also, the G2-ST group showed a significantly lower rate of target lesion revascularization than the G1-ST group (9.7% vs 17.1%, p = 0.01). Risk factors of 1-year mortality included cardiogenic shock or arrest at the time of ST, multivessel ST, left ventricular ejection fraction ≤40%, advanced age, and final thrombolysis in myocardial infarction flow grade ≤2. In conclusion, patients with G2-ST showed a similar 1-year mortality to those with G1-ST, highlighting that ST remains a life-threatening complication in the second-generation DES era.

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Am J Cardiol: 30 Sep 2020; 132:52-58

Comparison of Complications and In-Hospital Mortality in Takotsubo (Apical Ballooning/Stress) Cardiomyopathy Versus Acute Myocardial Infarction.

Vallabhajosyula S, Barsness GW, Herrmann J, Anavekar NS, Gulati R, Prasad A

There are limited data on the incidence of complications and in-hospital outcomes, in patients with Takotsubo cardiomyopathy (TC), as compared with acute myocardial infarction (AMI). From 2007 to 2014, a retrospective cohort of TC was compared with AMI using the National Inpatient Sample database. Complications were classified as acute heart failure, ventricular arrhythmic, cardiac arrest, high-grade atrioventricular block, mechanical, vascular/access, pericardial, stroke, and acute kidney injury. Temporal trends, clinical characteristics, and in-hospital outcomes were compared. During the 8-year period, 3,329,876 admissions for AMI or TC were identified. TC diagnosis was present in 88,849 (2.7%). Compared with AMI admissions, those with TC were older, female, and of white race. Use of pulmonary artery catheter and mechanical ventilation was higher, but hemodialysis lower in TC. The overall frequency of complications was higher in TC (38.2% vs 32.6%). Complication rates increased in both groups over time, but the delta was greater for TC (23% [2007] vs 43% [2014]) compared with AMI (27% vs 36%). The TC cohort had a higher rate of heart failure (29% vs 16.6%) and strokes (0.5% vs 0.2%), but lower rates of other complications (all p <0.001). In-hospital mortality was lower for TC (2.6% vs 3.1%; p <0.001). TC was an independent predictor of lower in-hospital mortality in admissions with complications. In conclusion, compared with AMI, TC is associated with greater likelihood of heart failure, but lower rates of other complications and mortality. There has been a temporal increase in the rates of in-hospital complications and mortality due to TC.

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Am J Cardiol: 30 Sep 2020; 132:29-35

In-Hospital Outcomes of Left Ventricular Assist Device Implantation and Concomitant Valvular Surgery.

Briasoulis A, Yokoyama Y, Kuno T, Ueyama H, ... Alvarez P, Malik AΗ

Valvular heart disease is common among left ventricular assist device (LVAD) recipients. However, its management at the time of LVAD implantation remains controversial. Patients who underwent LVAD implantation and concomitant aortic (AVR), mitral (MVR), or tricuspid valve (TVR) repair or replacement from 2010 to 2017 were identified using the national inpatient sample. End points were in-hospital outcomes, length of stay, and cost. Procedure-related complications were identified via ICD-9 and ICD-10 coding and analysis was performed via mixed effect models. A total of 25,171 weighted adults underwent LVAD implantation without valvular surgery, 1,329 had isolated TVR, 1,021 AVR, 377 MVR, and 615 had combined valvular surgery (411 had TVR + AVR, 115 TVR + MVR, 62 AVR + MVR, 25 AVR + MVR + TVR). During the study period, rates of AVR decreased and combined valvular surgeries increased. Patients who underwent TVR or combined valvular surgery had overall higher burden of co-morbidities than LVAD recipients with or without other valvular procedures. Postoperative bleeding was higher with AVR whereas acute kidney injury requiring dialysis was higher with TVR or combined valvular surgery. In-hospital mortality was higher with AVR, MVR, or combined surgery without differences in the rates of stroke. Length of stay did not differ significantly among groups but cost of hospitalization and nonroutine discharge rates were higher for cases of TVR and combined surgery. Approximately 1 in 9 LVAD recipients underwent concomitant valvular surgery and TVR was the most frequently performed procedure. In-hospital mortality and cost were lower among those who did not undergo valvular surgery.

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Am J Cardiol: 30 Sep 2020; 132:87-92

Impact of Gender on Transcatheter Aortic Valve Implantation Outcomes.

Stehli J, Dagan M, Zaman S, Koh JQS, ... Walton A, Duffy SJ

Previous studies indicate that women who underwentwho underwent transcatheter aortic valve implantation (TAVI) have poorer 30-day outcomes compared with men. However, the effect of gender as a prognostic factor for long-term outcomes following TAVI remains unclear. Between 2008 and 2018, all patients (n = 683) who underwent TAVI in 2 centres in Melbourne, Australia were prospectively included in a registry. The primary end-point was long-term mortality. The secondary end points were Valve Academic Research Consortium-2 (VARC-2) in-hospital complications and mortality at 30-days and 1-year. Of 683 patients, 328 (48%) were women. Women had a higher mean STS-PROM score (5.2 ± 3.1 vs 4.6 ± 3.5, p < 0.001) but less co-morbidities than men. Women had a significantly higher in-hospital bleeding rates (3.3% vs 1.0%, Odds Ratio 4.21, 95% confidence interval [CI] 1.16 to15.25, p = 0.027) and higher 30-day mortality (2.4% vs 0.3%, hazard ratio [HR] 8.75, 95% CI 1.09 to 69.6, p = 0.040) than men. Other VARC-2 outcomes were similar between genders. Overall mortality rate was 36% (246) over a median follow up of 2.7 (interquartile rang [IQR] 1.7 to 4.2) years. Median time to death was 5.3 (95% CI 4.7 to 5.7) years. One-year mortality was similar between genders (8.3% vs 7.8%), as was long-term mortality (HR = 0.91, 95% CI 0.71 to 1.17, p = 0.38). On multivariable analysis, female gender was an independent predictor for 1-year mortality (HR = 2.33, 95% CI 1.11 to 4.92, p = 0.026), but not long-term mortality (HR = 0.78, 95% CI 0.54 to 1.14, p = 0.20). In the women only cohort, STS-PROM was the only independent predictor of long-term mortality (HR 1.88, 95% CI 1.42 to 2.48, p < 0.001). In conclusion, women had higher rates of peri-procedural major bleeding and 30-day mortality following TAVI. However, long-term outcomes were similar between genders.

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Am J Cardiol: 14 Oct 2020; 133:98-104

Meta-Analysis of the Effect of Percutaneous Coronary Intervention on Death and Myocardial Infarction in Patients With Stable Coronary Artery Disease and Inducible Myocardial Ischemia.

Radaideh Q, Osman M, Kheiri B, Al-Abdouh A, ... Shammas NW, Boden WE
Background
There has been a continuous debate about the survival benefit of percutaneous coronary intervention (PCI) for the management of patients with stable ischemic heart disease (SIHD) and moderate to severe ischemia. In this study we aimed to summarize the currently available evidence from randomized controlled trials (RCTs) on PCI versus medical therapy (MT) for patients with SIHD.
Methods
An electronic database search was conducted for RCTs that compared PCI on top of MT versus MT alone. A random effects model was used to calculate relative risk (RR) and 95% confidence intervals (CIs).
Results
A total of 7 RCTs with 10,043 patients with a mean age of 62.54 ± 1.56 years and a median follow up of 3.9 years were identified. Among patients with SIHD and moderate to severe ischemia by stress testing, PCI didn\'t show any benefit for the primary outcome of all-cause mortality compared to MT(RR = 0.85; 95% CI 0.646-1.12; p = 0.639). There was also no benefit in cardiovascular (CV) death (RR = 0.88 ; 95% CI 0.71-1.09; p = 0.18) or myocardial infarction (MI) (RR = 0.271; 95% CI 0.782-1.087; P = 0.327) in the PCI group as compared to MT.
Conclusion
Among patients with SIHD and evidence of moderate to severe ischemia by stress testing, PCI on top of MT appears to add no mortality benefit as compared to with MT alone.

Copyright © 2020 Elsevier Inc. All rights reserved.

Am J Cardiol: 14 Oct 2020; 133:171-174

Five-Year Outcomes and Prognostic Value of Feature-Tracking Cardiovascular Magnetic Resonance in Patients Receiving Early Prereperfusion Metoprolol in Acute Myocardial Infarction.

Podlesnikar T, Pizarro G, Fernández-Jiménez R, Montero-Cabezas JM, ... Ibáñez B, Delgado V

The aim of the present study was to investigate the long-term impact of early intravenous metoprolol in ST-segment elevation myocardial infarction (STEMI) patients in terms of left ventricular (LV) strain with feature-tracking cardiovascular magnetic resonance (CMR) and its association with prognosis. A total of 270 patients with first anterior STEMI enrolled in the randomized METOCARD-CNIC clinical trial, assigned to receive up to 15 mg intravenous metoprolol before primary percutaneous coronary intervention versus conventional STEMI therapy, were included. LV global circumferential (GCS) and longitudinal (GLS) strain were assessed with feature-tracking CMR at 1 week after STEMI in 215 patients. The occurrence of major adverse cardiac events (MACE) at 5-year follow-up was the primary end point. Among 270 patients enrolled, 17 of 139 patients assigned to metoprolol arm and 31 of 131 patients assigned to control arm experienced MACE (hazard ratio [HR] 0.500, 95% confidence interval [CI] 0.277 to 0.903; p = 0.022). Impaired LV GCS and GLS strain were significantly associated with increased occurrence of MACE (GCS: HR 1.208, 95% CI 1.076 to 1.356, p =0.001; GLS: HR 1.362, 95% CI 1.180 to 1.573, p < 0.001). On multivariable analysis, LV GLS provided incremental prognostic value over late gadolinium enhancement (LGE) and LV ejection fraction (LVEF) (LGE + LVEF chi-square = 12.865, LGE + LVEF + GLS chi-square = 18.459; p =0.012). Patients with GLS ≥-11.5% (above median value) who received early intravenous metoprolol were 64% less likely to experience MACE than their counterparts with same degree of GLS impairment (HR 0.356, 95% CI 0.129 to 0.979; p = 0.045). In conclusion, early intravenous metoprolol has a long-term beneficial prognostic effect, particularly in patients with severely impaired LV systolic function. LV GLS with feature-tracking CMR early after percutaneous coronary intervention offers incremental prognostic value over conventional CMR parameters in risk stratification of STEMI patients.

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

Am J Cardiol: 14 Oct 2020; 133:39-47

Risk Differences in Secondary Prevention Patients Who Present With Acute Coronary Syndrome and Implications of Guideline-Directed Cholesterol Management.

Kong NW, Bavishi A, Amaral AP, Tibrewala A, ... Silberman P, Stone NJ

The 2018 American College of Cardiology/American Heart Association cholesterol guidelines for secondary prevention identified a group of \"very high risk\" (VHR) patients, those with multiple major atherosclerotic cardiovascular disease (ASCVD) events or 1 major ASCVD event with multiple high-risk features. A second group, \"high risk\" (HR), was defined as patients without any of the risk features in the VHR group. The incidence and relative risk differences of these 2 groups in a nontrial population has not been well characterized. Using the Northwestern Medicine Enterprise Data Warehouse, we compared the incidence of VHR and HR patients as well as their relative risk for cardiovascular morbidity and mortality in a single-center, large, academic, retrospective cohort study. Total 1,483 patients with acute coronary events from January 2014 to December 2016 were risk stratified into VHR and HR groups. International Classification of Diseases versions 9 and 10 were used to assess for composite events of unstable angina pectoris, non-ST elevation myocardial infarction, or ST-elevation myocardial infarction, ischemic stroke, or all-cause death with a median follow-up of 3.3 years. VHR patients were found to have 87 ± 5.4 composite events per 1,000 patient-years compared with HR patients who had 33 ± 5.1 events per 1,000 patient-years (p <0.001). VHR group had increased risk of future events as compared to the HR group (multivariable adjusted hazard ratio 1.66 [1.01 to 2.74], p = 0.047). In conclusion, these results support the stratification of patients into the VHR and HR risk groups for secondary prevention.

Copyright © 2020 Elsevier Inc. All rights reserved.

Am J Cardiol: 14 Oct 2020; 133:1-6

Association between coronary atherosclerotic burden and all-cause mortality among patients undergoing exercise versus pharmacologic stress-rest SPECT myocardial perfusion imaging.

Rozanski A, Gransar H, Miller RJH, Hayes SW, ... Thomson LEJ, Berman DS
Background and aims
Patients with suspected coronary artery disease who undergo stress SPECT myocardial perfusion imaging (MPI) and require pharmacologic stress are at substantially increased mortality risk compared to those who can exercise. However, the mechanisms underlying this increased risk are not well delineated. To test whether increased atherosclerotic burden accounts for this increased risk, we assessed the association between coronary artery calcium (CAC) scores and mortality risk among patients undergoing exercise versus pharmacologic SPECT MPI.
Methods
We assessed all-cause mortality in 2,151 patients, followed for 12.2 ± 3.4 years, after undergoing stress-rest SPECT-MPI and CAC scanning within 3 months of each other. Patients were divided according to their mode of stress testing (exercise or pharmacologic). We further employed propensity analysis to create a subgroup of exercise and pharmacologic subgroups with comparable age, symptoms, and coronary risk factors.
Results
Despite greater age and worse clinical profiles, pharmacologic and exercise patients had similar CAC scores. However, the hazard ratio (95% CI) for mortality was substantially greater among pharmacologic patients: 2.39 (1.83-3.10). For each level of CAC abnormality, pharmacologic patients had >2-fold increased risk adjusted hazard ratio for all-mortality risk (p < 0.05 for each CAC level). Among propensity-matched exercise versus pharmacologic patients, the same findings were observed.
Conclusions
Among patients referred for stress-rest SPECT-MPI and CAC scoring, pharmacologic patients have substantially increased mortality risk compared to exercise patients, despite having comparable levels of coronary atherosclerosis.

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

Atherosclerosis: 29 Sep 2020; 310:45-53

Optimal Dose and Type of β-blockers in Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention.

Park J, Han JK, Kang J, Chae IH, ... Koo BK, Kim HS

The clinical benefit of β-blockers in modern reperfusion era is not well determined. We investigated the impact of β-blockers in acute coronary syndrome (ACS) after percutaneous coronary intervention. From the Grand-DES registry, a patient-level pooled registry consisting of 5 Korean multicenter prospective drug-eluting stent registries, a total of 6,690 ACS patients were included. Prescription records of dose and type of β-blockers were investigated trimonthly from discharge. Patients were categorized by the mean value of doses during the follow-up (≥50% [high-dose], ≥25% to <50% [medium-dose)], and <25% [low-dose] of the full dose that was used in each randomized clinical trial) and vasodilating property of β-blockers. Three-year cumulative risk of all-cause death, cardiac death, and myocardial infarction were assessed. Patients receiving β-blockers were associated with a lower risk of all-cause and cardiac death compared with those not receiving β-blockers (adjusted hazard ratio [aHR] 0.29, 95% confidence interval [CI] 0.24-0.35 for all-cause death; aHR 0.27, 95% CI 0.21-0.34 for cardiac death). Medium-dose β-blocker group was associated with a lower risk of cardiac death compared with high- and low-dose β-blocker groups (aHR 0.49, 95% CI 0.25-0.96, for high-dose; aHR 0.46, 95% CI 0.29-0.74, for low-dose). Patients receiving vasodilating β-blockers were associated with a lower risk of cardiac death compared with those receiving conventional β-blockers (aHR 0.58, 95% CI 0.40-0.84). In conclusion, β-blocker therapy was associated with better clinical outcomes in patients with ACS, especially with medium-dose and vasodilating β-blockers.

Copyright © 2020. Published by Elsevier Inc.

Am J Cardiol: 26 Sep 2020; epub ahead of print

Incidence, Characteristics, and Outcomes of Emergent Isolated Coronary Artery Bypass Grafting.

Elsisy MF, Stulak JM, Alkhouli M

Data on emergency coronary artery bypass surgery (CABG) are limited. We studied patients undergoing isolated CABG at Mayo Clinic between 1993 and 2019. Baseline characteristics and in-hospital outcomes of emergent CABG were described in consecutive eras (1993-2000, 2001-2010, 2011-2019). Cumulative survival was estimated by the Kaplan Meier method for the overall group, and stratified by the indication of surgery. Among the 14,455 isolated CABG included, 427 (2.95%) were emergent. The number of emergent CABG decreased from 222, to 150, and 55 in the consecutive study eras. There was a temporal increase in the prevalence of heart failure, but no change in mean age, and prevalence of hypertension, diabetes, renal failure, or atrial fibrillation. The proportion of patients with failed/complicated percutaneous coronary intervention decreased from 38.2% in 1993-2000 to 22.7% in 2001-2010 and 25.5% in 2011-2019 (p=0.003). In 2011-2019, 100% of patient received an internal mammary graft compared with 75.6% in 1993-2000 (P<0.001). Operative mortality was 8.7% overall (8.6% in 1993-2000, 10.0% in 2001-2010, and 5.5% in 2011-2019, p=0.56). There were no differences in post-operative complications except for the incidence of renal failure and new dialysis which increased over time. Predicted 10-year survival was 57.0% and was not different according to CABG indication (p=0.12). In conclusion, we documented a temporal decrease in the incidence of emergent CABG between 1993 and 2019, especially those performed due to complications of coronary interventions. Despite the higher prevalence of left ventricular dysfunction and the more complete revascularization in more recent years, in-hospital mortality did not increase.

Copyright © 2020. Published by Elsevier Inc.

Am J Cardiol: 26 Sep 2020; epub ahead of print

Impact of High-Density Lipoprotein Levels on Cardiovascular Outcomes of Patients Undergoing Percutaneous Coronary Intervention with Drug Eluting Stents.

Roumeliotis A, Claessen B, Dangas G, Torguson R, ... Kini A, Mehran R

Low levels of high-density lipoprotein (HDL) have been associated with adverse cardiovascular events in epidemiologic studies. Evidence regarding its role in patients undergoing percutaneous coronary intervention (PCI) is scarce. We evaluated consecutive patients undergoing PCI with drug eluting stents from 2012 to 2017, excluding those with unavailable baseline HDL, age < 18 years, presentation with ST-segment elevation myocardial infarction (MI) or shock, and coexisting neoplastic disease. The final population was stratified according to baseline HDL levels into reduced and non-reduced HDL cohorts, with cut-off value 40mg/dL in males and 50mg/dL in females. The primary endpoint was 1-year major adverse cardiovascular events (MACE), defined as the composite of death, MI or target vessel revascularization (TVR). Among 10,843 patients included, 6,511 (60%) had reduced HDL, and 4,332 (40%) non-reduced HDL. The rate of 1-year MACE was similar between the two groups (7.5% vs. 6.6%; p=0.14). Although mortality and MI rates were comparable, reduced HDL was associated with significantly higher TVR 5.2% vs. 4.0%; p=0.02, a finding that attenuated after multivariable adjustment (adjusted hazard ratio 1.18, p=0.14). Sex subgroup analysis included 7,718 (71.2%) males and 3,125 (28.8%) females. Among men, there was a trend towards higher MACE in those with reduced HDL (7.4% vs. 6.0%; p=0.08) mostly driven by TVR (5.4% vs. 3.7%; p=0.005). No association between HDL and 1-year outcomes was evident in females. Assessment for interaction between sex and reduced HDL did not reach statistical significance. In conclusion, reduced baseline HDL was not associated with increased risk of MACE in a contemporary PCI population.

Copyright © 2020. Published by Elsevier Inc.

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

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, 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. Published by Elsevier Inc.

Am J Cardiol: 26 Sep 2020; epub ahead of print

Association of coronary calcium score with endothelial dysfunction and arterial stiffness.

Torngren K, Rylance R, Björk J, Engström G, ... Malmqvist U, Erlinge D
Background and aims
The aim of the study was to determine potential associations between endothelial dysfunction and arterial stiffness, measured by peripheral arterial tonometry, and coronary artery calcium score (CACS) assessed by computed tomography (CT).
Methods and results
The BIG3 study is a prospective longitudinal, non-interventional, pulmonary-cardiovascular cohort study exploring the three major smoking-induced diseases: cardiovascular disease, chronic obstructive pulmonary disease, and lung cancer, in a 45-75 aged cohort (mean 62 years), enriched in smokers. Computed tomography of the chest with assessment of CACS was performed in a selected subset of the participants (n = 2080). Peripheral arterial tonometry (EndoPAT) was used to assess endothelial function and arterial stiffness measured as reactive hyperaemia index (RHI) and augmentation index (AI), respectively. We observed significant associations of CACS, endothelial dysfunction, and arterial stiffness with several risk factors for coronary heart disease including age, sex, BMI, diabetes mellitus, and blood pressure. There was significant association of CACS, classified into three levels of severity, with RHI and AI (p = 0.0005 and p = 0.0009, respectively). For groups of increasing CACS (0, 1-400 and > 400 Agatston score), RHI decreased from median 1.89 (1.58-2.39), and 1.93 (1.62-2.41) to 1.77 (1.51-2.10). AI increased from median 14.3 (5.7-25.2), and 16.4 (8.1-27.6) to 18.0 (9.1-29.2). RHI, but not AI, remained significantly associated with CACS after risk factors adjustment.
Conclusions
In this large study of coronary artery calcium and vascular function, we found an association between CACS and both endothelial dysfunction and arterial stiffness, indicating that they may reflect similar mechanisms for development of cardiovascular disease.

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

Atherosclerosis: 25 Sep 2020; 313:70-75

Predictors and In-Hospital Outcomes Among Patients Using a Single Versus Bilateral Mammary Arteries in Coronary Artery Bypass Grafting.

Sareh S, Hadaya J, Sanaiha Y, Aguayo E, ... Omari B, Benharash P

The benefit of bilateral mammary artery (BIMA) use during coronary artery bypass grafting (CABG) continues to be debated. This study examined nationwide trends in BIMA use and factors influencing its utilization. Using the National Inpatient Sample, adults undergoing isolated multivessel CABG between 2005 and 2015 were identified and stratified based on the use of a single mammary artery or BIMA. Regression models were fit to identify patient and hospital level predictors of BIMA use and characterize the association of BIMA on outcomes including sternal infection, mortality, and resource utilization. An estimated 4.5% (n = 60,698) of patients underwent CABG with BIMA, with a steady increase from 3.8% to 5.0% over time (p<0.001). Younger age, male gender, and elective admission, were significant predictors of BIMA use. Moreover, private insurance was associated with higher odds of BIMA use (adjusted odds ratio 1.24) compared with Medicare. BIMA use was not a predictor of postoperative sternal infection, in-hospital mortality, or hospitalization costs. Overall, BIMA use remains uncommon in the United States despite no significant differences in acute postoperative outcomes. Several patient, hospital, and socioeconomic factors appear to be associated with BIMA utilization.

Copyright © 2020 Elsevier Inc. All rights reserved.

Am J Cardiol: 31 Oct 2020; 134:41-47

Trends in Utilization and Safety of In-Hospital Coronary Artery Bypass Grafting During a Non-ST-Segment Elevation Myocardial Infarction.

Elbaz-Greener G, Rozen G, Kusniec F, Marai I, ... Planer D, Amir O

Up to 10% of non-ST-segment elevation myocardial infarction (NSTEMI) patients require coronary artery bypass graft (CABG) surgery during their hospitalization. Contemporary, real-world, data regarding CABG utilization and safety in NSTEMI patients are lacking. Our objectives were to investigate the contemporary trends in utilization and outcomes of CABG in patients admitted for NSTEMI. Using the 2003 to 2015 National Inpatient Sample data, we identified hospitalizations for NSTEMI, during which a CABG was performed. Patients\' sociodemographic and clinical characteristics, incidence of surgical complications, length of stay, and mortality were analyzed. Multivariate analyses were performed to identify predictors of in-hospital complications and mortality. An estimated total of 440,371 CABG surgeries, during a hospitalization for NSTEMI, were analyzed. The utilization of CABG was steady over the years. The data show increasing prevalence of individual co-morbidities as well as cases with Deyo Co-morbidity Index ≥2 (p <0.001). High, 26.4%, complication rate was driven mainly by cardiac and pulmonary complications. The mortality rate declined from 3.6% in 2003 to an average of 2.4% during 2010 to 2015. Older age, female gender, heart failure, and delayed CABG timing were independent predictors of adverse outcomes. In conclusion, utilization of in-hospital CABG as the primary revascularization strategy in patients with NSTEMI remained steady over the years. These data reveal the raising prevalence of co-morbidities during the study. High complication rate was recorded; however, the mortality declined over the years to about 2.4%. Delaying CABG was associated with small but statistically significant worsening in outcomes.

Copyright © 2020 Elsevier Inc. All rights reserved.

Am J Cardiol: 31 Oct 2020; 134:32-40

Incidence and Impact of Thrombocytopenia in Patients Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents.

Park S, Ahn JM, Kim TO, Park H, ... Park SJ,

Platelets are crucial in the pathophysiology of coronary artery disease and are a major target of antithrombotic agents in patients receiving percutaneous coronary intervention (PCI). We sought to evaluate the incidence and prognostic impact of thrombocytopenia on clinical outcomes in patients undergoing PCI with drug-eluting stents (DES). We evaluated consecutive patients who received PCI with DES in the IRIS-DES registry between April 2008 and December 2017. Patients were divided into 2 groups based on the presence of thrombocytopenia (platelet count <150 × 10/L) at baseline. The primary outcome was all-cause mortality, and secondary outcomes included the composite outcome of death, myocardial infarction (MI), and stroke, and major bleeding. Complete follow-up data were available for 1 to 5 years (median, 3.1). Among 26,553 eligible patients, 1,823 (6.9%) had thrombocytopenia at baseline. At 5 years, the incidences of all-cause mortality (15.6% vs 8.1%, p <0.001), composite outcome (23.2% vs 15.6%, p <0.001), and major bleeding (3.7% vs 2.2%, p <0.001) were significantly higher in patients with thrombocytopenia than in those without thrombocytopenia. In multivariable Cox proportional-hazards models, thrombocytopenia was significantly associated with increased risks of all-cause mortality (hazard ratio 1.26, 95% confidence interval 1.07 to 1.48, p = 0.01) and major bleeding (hazard ratio 1.41, 95% confidence interval 1.04 to 1.91, P=0.03). In conclusion, among who patients underwent PCI with DES, the incidence of thrombocytopenia was 6.9%. Baseline thrombocytopenia was significantly associated with increased risks of mortality and major bleeding.

Copyright © 2020 Elsevier Inc. All rights reserved.

Am J Cardiol: 31 Oct 2020; 134:55-61

Safety and Efficacy of Single Versus Dual Antiplatelet Therapy After Left Atrial Appendage Occlusion.

Patti G, Sticchi A, Verolino G, Pasceri V, ... Colombo A,

The optimal antiplatelet strategy after left atrial appendage (LAA) occlusion able to protect from device-related thrombosis, paying the lowest price in terms of bleeding increase, is unclear. In a real-world, observational study we performed a head-to-head comparison of single versus dual antiplatelet therapy (SAPT vs DAPT) in patients who underwent LAA occlusion. We included 610 consecutive patients, stratified according to the type of post-procedural antiplatelet therapy (280 on SAPT and 330 on DAPT). Primary outcome measure was the incidence of the net composite end point including Bleeding Academic Research Consortium classification 3-5 bleeding, major adverse cardiovascular events or device-related thrombosis at 1-year follow-up. The use of SAPT compared with DAPT was associated with similar incidence of the primary net composite end point (9.3% vs 12.7% p = 0.22), with an adjusted hazard ratio (HR) of 0.69, 95% confidence interval 0.41 to 1.15; p = 0.15) at multivariate analysis. However, SAPT significantly reduced Bleeding Academic Research Consortium classification 3-5 bleeding (2.9% vs 6.7%, p = 0.038; adjusted HR 0.37, 0.16 to 0.88; p = 0.024). The occurrence of ischemic events (major adverse cardiovascular events or device-related thrombosis) was not significantly different between the 2treatment strategies (7.8% vs 7.4%; adjusted HR 1.34, 0.70 to 2.55; p = 0.38). In patients who underwent LAA occlusion, post-procedural use of SAPT instead of DAPT was associated with reduction of bleeding complications, with no significant increase in the risk of thrombotic events. These hypothesis-generating findings should be confirmed in a specific, randomized study.

Copyright © 2020 Elsevier Inc. All rights reserved.

Am J Cardiol: 31 Oct 2020; 134:83-90

Blood acetylcholinesterase activity is associated with increased 10 year all-cause mortality following coronary angiography.

Shenhar-Tsarfaty S, Brzezinski RY, Waiskopf N, Finkelstein A, ... Soreq H, Arbel Y
Background and aims
Parasympathetic dysfunction is associated with increased risk for major adverse cardiovascular events (MACE). However, clinically validated biomarkers that reflect parasympathetic activity are not yet available. We sought to assess the ability of serum cholinesterase activity to predict long term survival in patients undergoing coronary angiography.
Methods
We prospectively followed 1002 consecutive patients undergoing clinically indicated coronary angiography (acute coronary syndrome or stable angina). We measured blood acetylcholinesterase (AChE) activity using the acetylcholine analog acetylthiocholine. Mortality rates were determined up to 10 years of follow-up. We divided our cohort into 3 groups with low, intermediate and high AChE activity by a Chi-square automatic interaction detection method (CHAID).
Results
Patients with lower than cutoff levels of AChE (<300 nmol/min/ml) had higher mortality rates over 10 years of follow-up, after adjusting for conventional risk factors, biomarkers, clinical indication, and use of medications (HR = 1.6, 95% CI 1.1-2.5, p = 0.02). Patients with intermediate levels of AChE (300-582 nmol/min/ml) were also at increased risk for death (HR = 1.4, 95% CI 1.1-1.9, p = 0.02). AChE was inversely correlated with C-reactive protein, troponin I, fibrinogen and neutrophil/lymphocyte ratio levels.
Conclusions
Patients presenting for coronary angiography with low levels of serum AChE activity are at increased risk for death during long term follow-up.

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

Atherosclerosis: 08 Oct 2020; 313:144-149

Long-Term Outcomes Stratified by Body Mass Index in Patients Undergoing Transcatheter Aortic Valve Implantation.

Quine EJ, Dagan M, William J, Nanayakkara S, ... Stub D, Walton AS

Transcatheter aortic valve implantation (TAVI) is emerging as the default strategy for older patients with severe, symptomatic, trileaflet aortic stenosis. Increased body-mass index (BMI) is associated with a protective effect in patients undergoing percutaneous coronary intervention. We assessed whether elevated BMI was associated with a similar association in TAVI. We evaluated prospectively collected data from 634 patients who underwent TAVI at 2 centres from August 2008 to April 2019. Patients were stratified as normal weight (BMI 18.5-24.9kg/m, n=214), overweight (25-29.9kg/m, n=234) and obese (>30kg/m, n=185). Outcomes were reported according to VARC-2 criteria. Mortality was assessed using Cox proportional hazards regression analysis (median follow-up 2 years). Kaplan-Meier analysis was used to estimate cumulative mortality. Baseline differences were seen in age (85 vs. 84 vs. 82, p<0.001), STS-PROM score (4.3 vs. 3.4 vs. 3.6, p<0.001), sex (50% vs. 36% vs. 55% female, p<0.001), clinical frailty score (p=0.02), diabetes (21% vs. 29% vs. 40%, p<0.001), and presence of COPD (13% vs. 13% vs. 23%, p=0.009). On multivariable analysis there was no mortality difference between normal and obese patients (HR 0.70, CI 0.46-1.1 p=0.11), however overweight patients had significantly lower mortality (HR 0.56 CI 0.38-0.85, p=0.006). Variables independently associated with increased mortality were increasing age, male sex, COPD, prior balloon valvuloplasty and higher STS-PROM. In conclusion, overweight patients have lower long-term mortality when compared to normal weight and obese patients undergoing TAVI.

Copyright © 2020 Elsevier Ltd. All rights reserved.

Am J Cardiol: 01 Oct 2020; epub ahead of print

Admissions Rate and Timing of Revascularization in the United States in Patients With Non-ST-Elevation Myocardial Infarction.

Case BC, Yerasi C, Wang Y, Forrestal BJ, ... Weintraub WS, Waksman R

Clinical trials have shown improved outcomes with an early invasive approach for non-ST-elevation myocardial infarction (NSTEMI). However, real-world data on clinical characteristics and outcomes based on time to revascularization are lacking. We aimed to analyze NSTEMI rates, revascularization timing, and mortality using the 2016 Nationwide Readmissions Database. We identify patients who underwent diagnostic angiography and subsequently received either percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). Finally, revascularization timing and mortality rates (in-hospital and 30-day) were extracted. Our analysis included 748,463 weighted NSTEMI hospitalizations in 2016. Of these hospitalizations, 50.3% (376,695) involved diagnostic angiography, with 34.1% (255,199) revascularized. Of revascularized patients, 77.6% (197,945) underwent PCI and 22.4% (57,254) underwent CABG. Patients with more comorbidities tended to have more delayed revascularization. PCI was most commonly performed on the day of admission (32.9%; 65,155). This differs from CABG, which was most commonly performed on day 3 after admission (13.7%; 7,823). The in-hospital mortality rate increased after day 1 for PCI patients and after day 4 for CABG patients, whereas 30-day in-hospital mortality for both populations increased as revascularization was delayed. Our study shows that patients undergoing early revascularization differ from those undergoing later revascularization. Mortality is generally high with delayed revascularization, as these are sicker patients. Randomized clinical trials are needed to evaluate whether very early revascularization (<90 minutes) is associated with improved long-term outcomes in high-risk patients.

Copyright © 2020 Elsevier Inc. All rights reserved.

Am J Cardiol: 31 Oct 2020; 134:24-31

Balloon Filling Algorithm for Optimal Size of Balloon Expandable Prosthesis During Transcatheter Aortic Valve Replacement.

Schymik G, Radakovic M, Bramlage P, Schmitt C, Tzamalis P

Aim is to report on the results of an optimized balloon filling algorithm and suggest a refinement of the implantation approach to maximize safety. Appropriate sizing of balloon expandable valves during transcatheter aortic valve implantation is crucial. Study comprised 370 consecutive patients receiving SAPIEN 3 valve between 2015 and 2018. Valve expansion/recoil measurement in the inflow area, annular area, and outflow area was performed previously and postimplantation. Nominal balloon filling resulted in underexpansion-23 mm (20.96 mm), 26 mm (23.88 mm), and 29 mm (27.56 mm) SAPIEN 3 valves at the annular level. Increased balloon filling by 2 cc resulted in a gradual increase in valve diameter reaching 97.35% (23 mm), 96.50% (26 mm), and 96.11% (29 mm) of the nominal valve diameter. Final diameters were usually higher in the valvular inflow and outflow tracts. The 29 mm valve did not reach its nominal diameter with 2 cc overfilling and in none of inflow area (95.48%), annular area (96.11%), or outflow area (96.86%). Device success (by VARC II) was 96.2%. No root or septal rupture, device migration, mitral valve injury, coronary obstruction, or dissection occurred. Rate of new permanent pacemaker implantation was 8.3%. Paravalvular leakage was none or trace in most patients. Mean valve gradient was 10.77 mm Hg postprocedure. 1.9% of the patients had a maximum gradient of >40 mm Hg, 2.2% >20 mm Hg. In conclusion, an optimized balloon filling algorithm resulted in appropriate valve gradients, low levels of paravalvular leakage, low rates of permanent pacemaker implantation and no annular rupture.

Copyright © 2020. Published by Elsevier Inc.

Am J Cardiol: 31 Oct 2020; 134:108-115

Implementation of a Comprehensive ST-Elevation Myocardial Infarction Protocol Improves Mortality Among Patients With ST-Elevation Myocardial Infarction and Cardiogenic Shock.

Kumar A, Huded CP, Zhou L, Krittanawong C, ... Kapadia SR, Khot UN

Mortality in patients with STEMI-associated cardiogenic shock (CS) is increasing. Whether a comprehensive ST-elevation myocardial infarction (STEMI) protocol (CSP) can improve their care delivery and mortality is unknown. We evaluated the impact of a CSP on incidence and outcomes in patients with STEMI-associated CS. We implemented a 4-step CSP including: (1) Emergency Department catheterization lab activation; (2) STEMI Safe Handoff Checklist; (3) immediate catheterization lab transfer; (4) and radial-first percutaneous coronary intervention (PCI). We studied 1,272 consecutive STEMI patients who underwent PCI and assessed for CS incidence per National Cardiovascular Data Registry definitions within 24-hours of PCI, care delivery, and mortality before (January 1, 2011, to July 14, 2014; n = 723) and after (July 15, 2014, to December 31, 2016; n = 549) CSP implementation. Following CSP implementation, CS incidence was reduced (13.0% vs 7.8%, p = 0.003). Of 137 CS patients, 43 (31.4%) were in the CSP group. CSP patients had greater IABP-Shock II risk scores (1.9 ± 1.8 vs 2.8 ± 2.2, p = 0.014) with otherwise similar hemodynamic and baseline characteristics, cardiac arrest incidence, and mechanical circulatory support use. Administration of guideline-directed medical therapy was similar (89.4% vs 97.7%, p = 0.172) with significant improvements in trans-radial PCI (9.6% vs 44.2%, p < 0.001) and door-to-balloon time (129.0 [89:160] vs 95.0 [81:116] minutes, p = 0.001) in the CSP group, translating to improvements in infarct size (CK-MB 220.9 ± 156.0 vs 151.5 ± 98.5 ng/ml, p = 0.005), ejection fraction (40.8 ± 14.5% vs 46.7 ± 14.6%, p = 0.037), and in-hospital mortality (30.9% vs 14.0%, p = 0.037). In conclusion, CSP implementation was associated with improvements in CS incidence, infarct size, ejection fraction, and in-hospital mortality in patients with STEMI-associated CS. This strategy offers a potential solution to bridging the historically elusive gap in their care.

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

Am J Cardiol: 31 Oct 2020; 134:1-7

Implantable Cardioverter Defibrillator Utilization and Mortality Among Patients ≥ 65 Years of Age with a Low Ejection Fraction Following 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 following coronary revascularization. Patients in the NCDR Chest Pain-Myocardial Infarction (MI) Registry who presented with MI between 1/2/09-12/31/16, had a left ventricular (LV) ejection fraction (EF) ≤ 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 (1063 (10.6%) PCI and 171 (10.4%) CABG). Among PCI-treated patients, in-hospital ventricular arrhythmia (aHR 1.60, 95% CI 1.34-1.92), 2-week cardiology follow-up (aHR 1.48, 95% CI 1.29-1.70), readmission for heart failure (HF) (aHR 3.21, 95% CI 2.73-3.79), and readmission for MI (aHR 2.18, 95% CI 1.66-2.85) were positively associated with ICD implantation. Among CABG-treated patients, in-hospital ventricular arrhythmia (aHR 2.33, 95% CI 1.39-3.91) and HF readmission (aHR 3.14, 95% CI 1.96-5.04) 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 mortality (aHR 0.74, 95% CI 0.63-0.86). In conclusion, only 1 in 10 Medicare patients with low EF received an ICD within 1 year following revascularization. Contact with the healthcare system following discharge was associated with higher likelihood of ICD implantation. ICD implantation was associated with lower mortality following revascularization for MI.

Copyright © 2020 Elsevier Ltd. All rights reserved.

Am J Cardiol: 13 Oct 2020; epub ahead of print

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 (AS) 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 (PI). 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 nine studies were included in the final analysis, consisting of 1775 patients with early intervention and 3040 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: 0.24-0.53), cardiac mortality (RR: 0.36, 95% CI: 0.27-0.48) and non-cardiac mortality (RR: 0.40, 95% CI: 0.28-0.56). There was no difference in the risk of sudden cardiac death (RR: 0.46, 95% CI: 0.15-1.40), stroke (RR: 0.79, 95% CI: 0.17-3.64), myocardial infarction (RR: 0.44, 95% CI: 0.01-16.82) or heart failure hospitalization (RR: 0.18, 95% CI: 0.01-5.29) with early intervention compared with conservative management. In conclusion, early intervention is associated with reduced all-cause, cardiovascular, and non-cardiovascular 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. Published by Elsevier Inc.

Am J Cardiol: 12 Oct 2020; epub ahead of print

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 (RR 0.77; p= 0.22) and CVT (RR 1.29; p= 0.68) compared to patients without. The risk of stroke was higher in patients with CVT (RR 7.51; p< 0.001) as compared to 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 Ltd. All rights reserved.

Am J Cardiol: 12 Oct 2020; epub ahead of print

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 (CK-MB), creatine kinase (CK), and CK area under the curve (CK-AUC) values, with a pre-specified non-inferiority margin of 20%. Major bleeding was defined as type 2, 3 or 5 on the Bleeding Academic Research Consortium (BARC) classification. Eptifibatide bolus only was administered to 147 patients (20%), which were matched 1:1 to patients receiving conventional treatment. Based on peak CK-MB, CK and CK-AUC 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 pre-specified non-inferiority compared to 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 undergoing primary PCI was non-inferior regarding infarct size and resulted in less bleeding complications compared to conventional bolus and infusion treatment.

Copyright © 2020. Published by Elsevier Inc.

Am J Cardiol: 12 Oct 2020; epub ahead of print

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 sub-study 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 0.179-0.836; 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 0.116-0.891; 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. Published by Elsevier Inc.

Am J Cardiol: 12 Oct 2020; epub ahead of print

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 (PCI) for unprotected left main distal bifurcation lesions (ULMD) in patients with diabetes mellitus (DM) is not fully understood in drug eluting stent (DES) era. We identified 512 consecutive DM patients who underwent PCI for ULMD 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 endpoint was target lesion failure (TLF) at 3 years. TLF was defined as a composite of cardiac death, target lesion revascularization (TLR) and myocardial infarction (MI). 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, (1.86-7.11), 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, (2.19-18.9), p = 0.001]. TLR rate was comparable among 4 groups [Adjusted HR of severe CKD relative to the others 1.71, (0.60-4.82), p = 0.31]. In conclusions, among DM patients, those with severe CKD was extremely associated with worse clinical outcomes.

Copyright © 2020. Published by Elsevier Inc.

Am J Cardiol: 12 Oct 2020; 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 (CAD) is associated with poor prognosis. We sought to determine the merits of percutaneous coronary intervention (PCI) 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 (RR). 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 two 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% CI 1.10-1.70, p=0.005), angina (OR 2.28, 95% CI 1.83-2.85, p=<0.00001) and revascularization (OR 1.76, 95% CI 1.22- 2.54, p=0.002) compared to patients undergoing MVR for STEMI. The all-cause mortality (OR 1.18, 95% CI 0.91-1.53, p=0.22), cardiovascular mortality (OR 1.30, 95% CI 0.98-1.72, p=0.07), rate of heart failure (HF) (OR 1.17, 95% CI 0.86-1.59, p=0.31), need for coronary artery bypass graft (CABG) (OR 1.47, 95% CI 0.82-2.64, p=0.19), repeat myocardial infarction (MI) events (OR 1.23, 95% CI 0.93-1.64, p=0.15) and risk of stroke (OR 1.27 95% CI 0.68-2.34, 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 1.10-1.94, p=0.009). In contrast to the culprit-only approach, multivessel revascularization in patients with STEMI is associated with a significant reduction in MACE, angina and need for revascularization.

Copyright © 2020. Published by Elsevier Inc.

Am J Cardiol: 11 Oct 2020; epub ahead of print

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

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

While 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 undergoing 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 four 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, LDL 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% CI 1.04-1.44). The hazard ratio was no longer significant following 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. Published by Elsevier Inc.

Am J Cardiol: 11 Oct 2020; epub ahead of print

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 (ACS) cohort. Patients from the Australian Cooperative National Registry of Acute Coronary Care, Guideline Adherence and Clinical Events (CONCORDANCE) and Global Registry of Acute Coronary Events (GRACE Australia) between 2009-2019, were divided into BMI sub-groups (underweight: <18.5, healthy: 18.5-24.9, overweight: 25-29.9, obese: 30-39.9, 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 6months. 8503 patients were identified, mean age 64±13, 72% male. The BMI breakdown was: underweight- 95, healthy- 2140, overweight- 3258, obese- 2653, 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% vs 4%, aOR(95% CI): 0.49(0.27, 0.87); CV: 1% vs 3%, 0.51(0.27, 0.96). At 6-months underweight had higher mortality than healthy: all-cause: 11% vs 4%, 2.69(1.26, 5.76); CV: 7% vs 1%, 3.54(1.19, 10.54); while obese had lower mortality: all-cause: 1% vs 4%, 0.48(0.29, 0.77); CV: 0.4% vs 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 ACS. Obese patients had the best outcomes, suggesting persistence of the obesity paradox. However, there was a threshold effect, and favourable outcomes did not extend to the most obese.

Copyright © 2020. Published by Elsevier Inc.

Am J Cardiol: 11 Oct 2020; epub ahead of print

Association of plaque calcification pattern and attenuation with instability features and coronary stenosis and calcification grade.

Pugliese L, Spiritigliozzi L, Di Tosto F, Ricci F, ... Floris R, Chiocchi M
Background and aims
Coronary computed tomography (CT) allows calculating coronary artery calcium score (CACS). However, other CT features might be more strongly related to plaque vulnerability and risk of future coronary events. This study investigated the association of plaque calcification pattern and attenuation with plaque instability features, coronary artery disease (CAD) grade and CACS.
Methods
One-hundred patients with coronary stenosis associated with calcified plaques were considered for this analysis. CACS, CAD grade, calcification pattern and attenuation, features of plaque instability, and epicardial adipose tissue (EAT) thickness and attenuation were assessed with non-contrast and contrast-enhanced CT angiography.
Results
Of 373 calcified plaques, 131 were responsible for the highest degree of coronary stenosis (1.31 ± 0.53 per patient). Participants were stratified according to the features of the highest-grade lesion(s) into patients with large (35%), spotty (52%) or mixed (13%) calcification pattern and tertiles of plaque calcification attenuation (using the mean value for multiple lesions). Patients with large calcification pattern or higher plaque calcification attenuation had higher stenosis and CACS grade (and EAT attenuation), but lower plaque instability score, whereas those with spotty calcification pattern or lower plaque calcification attenuation had lower stenosis and CACS grade (and EAT attenuation), but higher plaque instability score. Among the instability features, low attenuation and napkin-ring sign, but not positive remodeling, were associated with a spotty pattern and a lower calcification attenuation.
Conclusions
Both the pattern and attenuation of calcification should be considered, in addition to CACS, for risk stratification of heavily calcified high-risk patients with non-critical coronary stenosis.

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

Atherosclerosis: 29 Sep 2020; 311:150-157

Supraventricular Tachycardia in Patients with Coronary Sinus Stenosis/Atresia: Prevalence, Anatomical Features, and Ablation Outcomes.

Weng S, Tang M, Zhou B, Yu F, ... Fang P, Zhang S
Background
Supraventricular tachycardia (SVT) with coronary sinus (CS) ostial atresia (CSA) or CS stenosis (CSS) causes difficulty in electrophysiological procedures, but its characteristics are poorly understood.
Objective
Study the anatomical and clinical features of SVT patients with CSA/CSS.
Methods
Of 6,128 SVT patients undergoing electrophysiological procedures, consecutive patients with CSA/CSS were enrolled, and the baseline characteristics, imaging materials, intraoperative data, and follow-up outcomes were analyzed.
Results
Thirteen patients, 7 with CSA and 6 with CSS, underwent the electrophysiological procedure. Decapolar catheters were placed into the proximal CS in 3 cases, while the rest were placed at the free-wall of the right atrium. Fourteen arrhythmias were confirmed: 4 atrioventricular nodal reentrant tachycardias, 5 left-sided accessory pathways, 3 paroxysmal atrial fibrillations, and 2 atrial flutters. In addition to 3 patients who underwent only an electrophysiological study, the acute ablation success rate was 100% in 10 cases, with no procedure-related complications. After a median follow-up period of 59.6 months, only 1 case of atypical atrial flutter recurred. For those cases (7 CSA and 2 CSS) with a total of 10 anomalous types of CS drainage, three types were classified: from the CS to the persistent left superior vena cava (n=3), from an unroofed CS (n=3), and from the CS to the small cardiac vein (n=3) or Thebesian vein (n=1).
Conclusion
Patients with CSA/CSS may develop different kinds of SVT. Electrophysiological procedures for such patients are feasible and effective. An individualized mapping strategy based on the three types of CS drainage will be helpful. This article is protected by copyright. All rights reserved.

This article is protected by copyright. All rights reserved.

J Cardiovasc Electrophysiol: 05 Oct 2020; epub ahead of print

State-of-the-art preclinical testing of the OMEGA left atrial appendage occluder.

De Backer O, Hafiz H, Fabre A, Lertsapcharoen P, ... Foley D, Sondergaard L
Objectives
This study aimed to present a new approach of thorough preclinical testing of a novel left atrial appendage (LAA) occluder device.
Background
The development of a safe and effective LAA occluder has been shown to be challenging.
Methods
The novel OMEGATM LAA occluder (Eclipse Medical, Ireland) was tested in a porcine model and three-dimensional (3D) human LAA models - this as a prelude to its first-in-human use.
Results
In a first series of in-vivo experiments, the OMEGATM LAA occluder was shown to have a satisfactory device biocompatibility in a porcine model. The design of the OMEGATM device was further refined and optimized following three more series of in-vivo experiments. The second generation OMEGATM device was designed with thinner wires, leading to a profile reduction. Based on in-vitro testing of different OMEGATM device sizes implanted at different depths in human three-dimensional (3D) LAA models, it could be determined that (1) the landing zone should be measured at a median depth of 12 mm from the LAA ostium; (2) the distal self-retaining inverted cup should have 10%-25% compression to minimize device embolization risk; and (3) the disc should be slightly inverted, i.e. pulled into the LAA, to promote complete LAA occlusion. The combined in-vivo and in-vitro testing resulted in an optimized pre-procedural planning of the first-in-human case treated with the OMEGATM device.
Conclusions
This series of carefully planned in-vivo and in-vitro experiments allowed demonstration of the safety and efficacy of the OMEGATM LAA occluder. This approach of thorough preclinical testing of medical devices may reduce the risk of complications in first-in-human cases and may become the standard approach for device development and preclinical testing in the future.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 08 Oct 2020; epub ahead of print

The Prognostic Value of Exercise Echocardiography after Percutaneous Coronary Intervention.

Marques A, Cruz I, João I, Almeida AR, ... Lopes LR, Pereira H
Background
Exercise echocardiography (EE) is a valuable noninvasive method for diagnostic and prognostic assessment of ischemic cardiac disease. The prognostic value of normal findings on EE is well known overall, but its role in patients who undergo percutaneous coronary intervention remains poorly validated. The aim of this study was to ascertain the prognostic value of treadmill EE and to determine predictors of cardiac events in this population, with an emphasis on nonpositive (negative or inconclusive) findings.
Methods
A retrospective single-center study was performed. It included 516 patients (83% man; mean age, 62 ± 9 years) previously subjected to percutaneous coronary intervention who underwent treadmill EE between 2008 and 2017. Demographic, clinical, echocardiographic, and angiographic data were collected. The occurrence of cardiac events (cardiac death, acute coronary syndrome, or coronary revascularization) during follow-up was investigated. A multivariate Cox regression analysis was used to evaluate predictors of cardiac events. The Kaplan-Meier method was used to evaluate event-free survival rates.
Results
The results of EE were negative for myocardial ischemia in 245 patients (47.5%), inconclusive in 144 (27.9%), and positive in 127 (24.6%). During a mean follow-up period of 40 ± 34 months, cardiac events occurred in 152 patients (29.5%). The positive and negative predictive values of EE were 81.6% and 85.3%, respectively. The sensitivity of the exercise test was 73.9%, with specificity of 90.1%. Predictors of cardiac events were typical angina (hazard ratio [HR], 1.95; 95% CI, 1.16-3.27; P = .011), a positive ischemic response detected by electrocardiographic monitoring during EE (HR, 2.01; 95% CI, 1.21-3.34; P = .007), and the test result (inconclusive result: HR, 1.06; 95% CI, 0.51-2.19; P = .878; positive result: HR, 4.35; 95% CI, 2.42-7.80; P < .001). Patients with inconclusive (log-rank P = .038) and positive (log-rank P < .001) results had significantly more cardiac events during follow-up than those with negative findings on EE. Focusing on those patients with nonpositive results, cardiac event-free survival rates at 1, 3, and 5 years were 96.6 ± 0.9%, 88.3 ± 1.9%, and 79.5 ± 2.6%, respectively. In this subpopulation, an inconclusive test result (HR, 1.67; 95% CI, 1.03-2.70; P = .039), more extensive coronary artery disease (two vessels: HR, 1.37; 95% CI, 0.75-2.30; P = .304; three vessels: HR, 2.59; 95% CI, 1.38-4.87; P = .003), and arterial hypertension (HR, 2.07; 95% CI, 1.10-3.91; P = .025) were significantly associated with the occurrence of cardiac events.
Conclusion
Patients with known coronary disease with negative results on EE are at low risk for hard events. Patients with inconclusive results are at higher risk for cardiac events than those with negative results. The detection of patients with low-risk results on EE should decrease the number of unnecessary repeat invasive coronary angiographic examinations.

Copyright © 2020. Published by Elsevier Inc.

J Am Soc Echocardiogr: 05 Oct 2020; epub ahead of print

Impact of atrial fibrillation on outcomes following MitraClip: A contemporary population-based analysis.

Saad AM, Kassis N, Gad MM, Abdelfattah O, ... Shekhar S, Kapadia SR
Objectives
Despite the rising use of MC, the impact of preexisting AF, a common comorbidity, on short-term postprocedural outcomes is poorly defined. We sought to assess outcomes between patients with and without atrial fibrillation (AF) who underwent percutaneous mitral valve repair with MitraClip (MC).
Methods
In this retrospective cohort study, the Nationwide Readmissions Database was queried for patients who underwent MC between 2014-2017. Groups were stratified based on the presence of AF. Multivariable logistic regression analyses were performed to identify the association between AF and in-hospital stroke and mortality.
Results
Of the 15,570 patients who underwent MC, 7,740 (49.7%) had AF. AF patients were older (82 vs. 79 years, p < .001) and more comorbid. Patients with AF relative to without AF demonstrated increased rates of in-hospital ischemic (1.3% vs .0.7%, p < .001) and hemorrhagic stroke (0.3% vs. 0.1%, p = .007), longer duration of hospitalization (median 3 vs. 2 days, p < .001), and similar in-hospital mortality (2.8% vs. 2.6%, p = .52). After adjusting for comorbidities, age, sex, hospital procedural volume, and CHA2DS2-VASc, the presence of AF was associated with higher in-hospital stroke (OR = 2.096, 95%CI[1.503-2.921], p < .001) but not in-hospital mortality (OR = 1.012, 95%CI[0.828-1.238], p = .904). AF patients were more likely to be readmitted (16.8% vs.14.1%, p < .001) and die (1.5% vs. 0.9%, p = .005) within 30 days of discharge despite similar incidences of stroke (0.7% vs. 0.6%, p = .53).
Conclusions
The increased risk of in-hospital stroke, 30-day mortality, and longer hospitalization suggest the need for increased preprocedural optimization by means of stroke prevention strategies in those with AF undergoing MC.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 04 Oct 2020; epub ahead of print

Impact of individual stroke risk on outcome after Amplatzer left atrial appendage closure in patients with atrial fibrillation.

Häner JD, Fürholz M, Kleinecke C, Galea R, ... Meier B, Gloekler S
Objectives
To investigate periprocedural and long-term outcome of left atrial appendage closure (LAAC) using Amplatzer occluders with respect to individual pre-procedural stroke risk.
Background
LAAC is a proven strategy for prevention from stroke and bleeding in patients with nonvalvular atrial fibrillation not amenable to oral anticoagulation. Whether individual pre-procedural stroke risk may affect procedural and long-term clinical outcome after LAAC is unclear.
Methods
Multicenter study of consecutive patients who underwent Amplatzer-LAAC. Using pre-procedural CHADS score, outcomes were compared between a low (0-2 points) and a high stroke risk group (3-6 points).
Results
Five hundred consecutive patients (73.9 ± 10.1 years) who underwent Amplatzer-LAAC. Two hundred and forty eight had preprocedural CHADS score ≤ 2 points (low-risk group) and the remaining 252 patients had 3-6 points (high-risk group). Periprocedural complication rates (6.0% vs. 5.6%, p = .85), procedural success (LAAC without major periprocedural or device-related complications or major para-device leaks: 89.4% vs. 87.9%, p = .74), and 30-day-mortality (2.4% vs. 2.6%, p = .77) were comparable. After 1,346 patient-years (PY), the long-term composite efficacy endpoint (stroke, systemic embolism, cardiovascular, and unexplained death) was reached in 23/653 (3.5/100 PY) versus 52/693 (7.5/100 PY); HR = 2.13; 95%-CI, 1.28-3.65, p = .002) with stroke rates 67% and 68% lower than anticipated by preprocedural CHADS score. Combined safety endpoint (major periprocedural complications and major, life-threatening or fatal bleedings) occurred in 22/653 (3.4/100 PY) versus 28/693 (4.0/100 PY); HR = 1.20; 95%-CI, 0.66-2.20, p = .52).
Conclusions
Compared with patients at low risk of stroke, LAAC with Amplatzer devices is associated with similar safety and efficacy in high-risk patients in our study.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 05 Oct 2020; epub ahead of print

Commentary: Temporarily omitting oral anticoagulants early after stenting for acute coronary syndromes patients with atrial fibrillation.

Limbruno U, Goette A, De Caterina R

The joint occurrence of atrial fibrillation (AF) and an acute coronary syndrome (ACS) entails a three-dimensional - cardioembolic, coronary and hemorrhagic - risk. Triple antithrombotic therapy (TAT), i.e., oral anticoagulation (OAC) on top of dual antiplatelet therapy (DAPT), has been the default strategy for such patients until recently. Due to the high hemorrhagic burden of TAT, several dual antithrombotic therapy (DAT) regimens, i.e., OAC plus a single antiplatelet agent, have been proposed in randomized trials with the aim of improving safety without hampering efficacy. Current guidelines and consensus documents still leave here, however, OAC as an undisputed cornerstone. Such documents do not sufficiently distinguish between the ischemic risk due to ACS treated with stenting and the one due to AF, which may dissociate in some patients and definitely have a different time course. The possibility of postponing the introduction of OAC in such conditions, rather taking advantage of the use of newer P2Y inhibitors prasugrel and ticagrelor, is not currently sufficiently contemplated in contemporary documents. We here question the claimed lack of alternatives to the \"anticoagulant always and immediately\" approach in most such patients, propose some risk simulations, claim that skipping anticoagulation in the presence of modern DAPT for one month after an ACS in the context of a high bleeding risk and a high coronary risk is a valuable, currently unlisted option, and raise the need of a proper trial on this controversial issue.

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

Int J Cardiol: 31 Oct 2020; 318:82-85

Long-term outcome of prosthesis-patient mismatch after transcatheter aortic valve replacement.

Compagnone M, Marchetti G, Taglieri N, Ghetti G, ... Galiè N, Saia F
Background
Incidence and long-term clinical consequences of prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR) are still unclear.
Methods
We enrolled 710 consecutive patients who underwent TAVR. PPM was defined as absent if the index orifice area (iEOA) was >0.85 cm2/m2, moderate if the iEOA was between 0.65 and 0.85 cm2/m2 or severe if the iEOA was <0.65 cm2/m2.
Results
Among the 566 patients fulfilling the study criteria, the distribution of PPM was as follows: 50.5% none (n = 286), 43% moderate PPM (n = 243) and 6.5% severe PPM (n = 37). At 5-year follow-up, patients with severe PPM had a significantly higher incidence of the combined endpoint of cardiovascular death, acute myocardial infarction and stroke (p = .025) compared with the other patients. After adjusting the results for possible confounders, severe PPM remained an independent predictor of long-term adverse outcome (HR: 2.46; 95% Confidence Interval: 1.10-5.53). The independent predictors of severe PPM were valve-in-valve procedure and body mass index. Balloon-expandable valves were not associated with higher rates of severe PPM in comparison with self-expandable valves (8% vs. 5%, respectively, p = .245).
Conclusions
In our study severe PPM emerged as a risk factor for long-term major adverse cardiac and cerebrovascular events.

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

Int J Cardiol: 31 Oct 2020; 318:27-31

Comparison of two biomarker only algorithms for early risk stratification in patients with suspected acute coronary syndrome.

Kavsak PA, Mondoux SE, Ma J, Sherbino J, ... Devereaux PJ, Worster A
Background
We developed a biomarker algorithm encompassing the clinical chemistry score (CCS; which includes the combination of a random glucose concentration, an estimated glomerular filtration rate and high-sensitivity cardiac troponin; hs-cTn) with the Ortho Clinical Diagnostics hs-cTnI assay (CCS-serial) and compared it to the cutoffs derived from Ortho Clinical Diagnostics 0/1 h (h) algorithm for 7-day myocardial infarction (MI) or cardiovascular (CV)-death.
Methods
The study cohort was an emergency department (ED) population (n = 906) with symptoms suggestive of acute coronary syndrome (ACS) who had two Ortho hs-cTnI results approximately 3 h apart. Diagnostic parameters (sensitivity/specificity/negative predictive value; NPV/positive predictive value; PPV) were derived for the CCS-serial and the 0/1 h algorithm for 7-day MI/CV-death. A safety analysis was performed for patients in the rule-out arms of the algorithms for 30-day MI/death.
Results
The CCS-serial algorithm yielded 100% sensitivity/NPV (32% low-risk) and 95.7% specificity/65% PPV (11% high-risk). The 0/1 h algorithm-cutoffs yielded sensitivity/NPV/specificity/PPV of 97.8%/99.4%/91.3%/50%, which classified 38% of patients as low-risk and 16% of patients as high-risk. Four patients (1.2%) in the 0/1 h algorithm-cutoff rule-out arm had a 30-day MI/death outcome as compared to zero patients in the CCS-serial rule-out arm (p = 0.06).
Conclusion
Both the CCS-serial and 0/1 h algorithm cutoffs yield high NPVs with a similar proportion of patients identified as low-risk. These data may be useful for sites who are unable to collect samples at 0/1 h in the emergency department.

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

Int J Cardiol: 14 Nov 2020; 319:140-143

Early experience with the Micro Plug Set for preterm patent ductus arteriosus closure.

Heyden CM, El-Said HG, Moore JW, Guyon PW, Katheria AC, Ratnayaka K
Objectives
We intend to describe early experience using a new, commercially available Micro Plug Set for preterm neonate and infant transcatheter patent ductus arteriosus (PDA) occlusion.
Background
Transcatheter PDA occlusion in premature neonates and small infants is safe and effective. The procedure is early in its evolution.
Methods
Procedural and short-term outcomes of preterm neonates and infants undergoing transcatheter PDA occlusion with a new, commercially available device were reviewed.
Results
Eight preterm neonates and infants born at median 27 weeks gestation (23-36 weeks) underwent transcatheter PDA device closure with the Micro Plug Set. The device is short (2.5 mm) with a range of diameters (3, 4, 5, 6 mm) and delivered through a microcatheter. Procedures were performed at median 41 days of age (12-88 days) and at 1690 g (760-3,310 g). Transvenous PDA device occlusion was performed with fluoroscopic and echocardiography guidance. All procedures were successful with complete PDA occlusion. There were no procedural or short-term adverse events.
Conclusions
Preterm neonate and infant transcatheter PDA device closure with a new, commercially available short and microcatheter delivered device (Micro Plug Set) was safe and effective in a small, early series of patients.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 25 Sep 2020; epub ahead of print

Hybrid treatment of aortic aneurism, type-A dissection, and aortic valve stenosis.

Lunardi M, Franzese I, Faggian G, Ribichini FL

Hybrid multidisciplinary interventions are attractive care options for heart valve and vascular diseases in high-risk patients. We describe the feasibility of staged hybrid aortic arch repair to treat a type Ia endoleak and transcatheter aortic valve replacement to treat an aortic valve stenosis, achieving an escape strategy to treat an unexpected type-A aortic dissection.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 25 Sep 2020; epub ahead of print

A safe and simple method for axIABP placement using a left axillary-radial technique.

Maatman B, Rios-Meza H, Guglin M, Revtyak G

In patients with severe heart failure, a percutaneous axillary intraaortic balloon pump (axIABP) may permit ambulation while awaiting destination therapy. Traditionally, an \"axillary-femoral\" approach has been used with femoral access for axillary angiography during insertion. We describe an \"axillary-radial\" technique for axIABP insertion and removal using the left radial artery.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 25 Sep 2020; epub ahead of print

Common carotid artery endovascular clamping for neuroprotection during carotid stenting: Flow-gate system as an innovative treatment approach.

Gabrielli R, Castrucci T, Siani A, Accrocca F, ... Cancellieri R, Bartoli S
Objectives
We here report our clinical experience in CAS management through common carotid artery endovascular clamping with FlowGate2 system.
Methods
Forty-five patients were enrolled with de novo asymptomatic internal carotid artery stenosis ≥70%. Cerebral protection during the stenting procedure was achieved using a unique endovascular clamping technique developed in our Institution which includes: (a) the occlusion of the common carotid artery only, through inflatable balloons integrated in the FlowGate2 Balloon Guide Catheter system; (b) flow inversion connecting catheter to 16 G blood cannula previously placed in arm vein; (c) after the placement of the stent, the flow inversion is maintained for 30 s to allow debris washout. The related primary end-point was the rate of Diffusion-weighted imaging magnetic resonance (DWI) micro-embolic scattering of infarction. The patient\'s clinical and the neurological status were assessed prior, during and after intervention, at discharge.
Results
Transient clamping intolerance was observed in two patients (2/45; 4%). One minor stroke (1/45; 2%) occurred 8 hr the procedure with DWI ipsilateral micro-embolic lesions. No major strokes or deaths were observed at 3 months follow-up. DWI demonstrated ipsilateral micro-embolic scattering of infarction, in one asymptomatic patient. In all patients, no worst changes in NIHSS scale assessment were recorded at 1, 3, and 6 months.
Conclusions
Our data confirmed the efficacy of FlowGate2 in terms of neuroprotection during CAS. To our knowledge, these are the first published data on this innovative approach developed in our institution. A large controlled trial is ongoing to confirm preliminary evidences.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 27 Sep 2020; epub ahead of print

Mon2-monocytes and increased CD-11b expression before transcatheter aortic valve implantation are associated with earlier death.

Pfluecke C, Wydra S, Berndt K, Tarnowski D, ... Linke A, Ibrahim K
Background
In the first three months after Transcatheter aortic valve implantation (TAVI), a remarkable number of patients have an unfavorable outcome. An inflammatory response after TAVI is suspected to have negative effects. The exact mechanisms remain unclear. We examined the influence of monocyte subpopulations on the clinical outcome, along with the degree of monocyte activation and further parameters of inflammation and platelet activation.
Methods
Flow-cytometric quantification analyses of peripheral blood were done in 120 consecutive patients who underwent TAVI (one day before TAVI and on day 1 and 7 after TAVI). Monocyte-subsets were defined by their CD14 and CD16 expression, monocyte-platelet-aggregates (MPA) by CD14/CD41 co-expression. The extent of monocyte activation was determined by quantification of CD11b-expression (activation epitope). Additionally, pro-inflammatory cytokines such as interleukin (IL)-6, IL-8, C-reactive protein were measured with the cytometric bead array method or standard laboratory tests.
Results
Elevated Mon2 (CD14CD16) - monocytes (38 vs. 62 cells/μl, p < 0.001) and a high expression of CD11b prior to TAVI (MFI 50.1 vs. 84.6, p < 0.05) were independently associated with death 3 months after TAVI. Mon2 showed the highest CD11b-expression and CD11b correlated with platelet activation and markers of systemic inflammation. Even CRP and IL-8 before TAVI were associated with death after TAVI. In contrast, a systemic inflammation response shortly after TAVI was not associated with early death.
Conclusions
Elevated Mon2-monocytes and a high level of monocyte activation before TAVI are associated with early mortality after TAVI. Chronic inflammation in aging patients seems to be an important risk factor after TAVI.

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

Int J Cardiol: 31 Oct 2020; 318:115-120

Predictors of reduced cardiac index in patients with acute submassive pulmonary embolism.

Ammari Z, Al-Sarie M, Ea A, Sangera R, ... Sun Z, Gupta R
Objectives
Determine the baseline clinical, laboratory, and echocardiographic values that predict reduced cardiac index (CI) among subjects with acute submassive pulmonary embolism (PE).
Background
Submassive PE represents a large portion of acute PE population and there is controversy regarding optimal treatment strategies for these patients. There is significant heterogeneity within the submassive PE population and further refinement of risk stratification may aid clinical decision-making.
Methods
We identified subjects with normotensive acute PE who underwent echocardiogram and right heart catheterization (RHC) prior to catheter-directed thrombolysis (CDT). We sought to determine the predictors of reduced CI, defined as CI < 2.2 L min m .
Results
Thirty-two subjects met the inclusion criteria and 41% had reduced CI. Baseline variables did not distinguish subjects with reduced versus normal CI. Brain natriuretic peptide (BNP) was significantly different between the reduced versus normal CI groups (BNP 440 vs. 160 pg/ml, p = .004, respectively). Univariate logistic regression identified BNP, right ventricular (RV):left ventricular (LV) diameter ratio, tricuspid annular plane systolic excursion (TAPSE), and right ventricular systolic pressure as predictors of reduced CI. In a multivariate logistic regression model, only TAPSE was an independent predictor of reduced CI. ROC curve analysis identified the following optimal cut points for prediction of reduced CI: BNP > 216 pg/ml, RV:LV ratio > 1.41, or TAPSE <1.6 cm.
Conclusions
Almost half of subjects with acute submassive PE have reduced CI, despite normal systemic blood pressure. Optimal cut points for BNP, RV:LV ratio, and TAPSE were identified to predict reduced CI among patients with acute PE. These findings may aid in clinical decision-making and risk stratification of patients with acute submassive PE.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 24 Sep 2020; epub ahead of print

Potential risk of perioperative thromboembolism in patients with antiphospholipid syndrome who undergo transcatheter aortic valve implantation: A case series.

Hoshi T, Hiraya D, Sato A, Ieda M

Antiphospholipid syndrome (APS) is an autoimmune disease characterized by a positive serum antiphospholipid antibody status. Patients with APS usually have an underlying hypercoagulable state, which can increase the risk of perioperative thromboembolism. We describe three patients with APS who underwent transcatheter aortic valve implantation for symptomatic severe aortic stenosis. Of them, two had complicated cerebrovascular events, and the other had no complications. Careful antithrombotic management is essential to minimize the risk of thromboembolism and bleeding in patients with APS.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 24 Sep 2020; epub ahead of print

Direct EBUS-guided transtracheal lymphosclerosis for plastic bronchitis after Fontan.

Hubrechts J, Dooms C, Maleux G, Gewillig M

We report on a new puncture technique with direct transtracheal mediastinal lymphatic access to treat plastic bronchitis after Fontan repair. High resolution contrast-enhanced spiral CT identified enlarged lymph nodes in the paratracheal region. Inguinal intranodal Gadolinium Dynamic Contrast-enhanced Magnetic Resonance lymphangiography (DCMRL) confirmed the pathologic centrifugal lymph flow passing through these lymph nodes before leaking into the bronchial tree. The abnormal hypertrophic paratracheal, subcarinal, and hilar lymph nodes were punctured with a 22G needle through an endobronchial ultrasound bronchoscope. Occlusion of the lymph vessels was obtained by injecting a mixture of lipiodol/NBCA N-butyl cyanoacrylate (Histoacryl) 5/1 under fluoroscopic control. There was a total remission of PB with now 10 months of follow-up.

© 2020 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 28 Sep 2020; epub ahead of print

Neighborhood socioeconomic status and aortic stenosis: A Swedish study based on nationwide registries and an echocardiographic screening cohort.

Andell P, Li X, Martinsson A, Nilsson PM, ... Smith JG, Sundquist K
Background
Aortic stenosis (AS) is the most common valvular heart disease in developed countries, confers high mortality in advanced cases, but can effectively be reversed using endovascular or open-heart surgery. We evaluated the association between AS and neighborhood socioeconomic status (NSES).
Methods
We used Swedish population-based nationwide registers and an echocardiography screening cohort during the study period 1997-2014. NSES was determined by an established neighborhood deprivation index composed of education, income, unemployment, and receipt of social welfare. Multilevel adjusted logistic regression models determined the association between NSES and incident AS (according to ICD-10 diagnostic codes).
Results
The study population of men and women (n=6,641,905) was divided into individuals living in high (n = 1,608,815 [24%]), moderate (n = 3,857,367 [58%]) and low (n = 1,175,723 [18%]) SES neighborhoods. There were 63,227 AS cases in total. Low NSES (versus high) was associated with a slightly increased risk of AS (OR 1.06 [95% CI 1.03-1.08]) in the nationwide study population. In the echocardiography screening cohort (n = 1586), the association between low NSES and AS was markedly stronger (OR: 2.73 [1.05-7.12]). There were more previously undiagnosed AS cases in low compared to high SES neighborhoods (3.1% versus 1.0%).
Conclusions
In this nationwide Swedish register study, low NSES was associated with a slightly increased risk of incident AS. However, the association was markedly stronger in the echocardiography screening cohort, which revealed an almost three-fold increase of AS among individuals living in low SES neighborhoods, possibly indicating an underdiagnosis of AS among these individuals.

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

Int J Cardiol: 31 Oct 2020; 318:153-159