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Background: Mortality after ST-segment elevation myocardial infarction (STEMI) is increased in patients with hypertension. The mechanisms underlying this association are uncertain. We sought to investigate whether patients with STEMI and prior hypertension have greater microvascular obstruction (MVO) and infarct size (IS) compared with those without hypertension., Methods: We pooled individual patient data from 7 randomized trials of patients with STEMI undergoing primary percutaneous coronary intervention (PCI) in whom cardiac magnetic resonance imaging was performed within 1 month after reperfusion. The associations between hypertension and MVO, IS, and mortality were assessed in multivariable adjusted models., Results: Among 2174 patients (61.3 ± 12.6 years, 76% male), 1196 (55.0%) had hypertension. Patients with hypertension were older, more frequently diabetic and had more extensive coronary artery disease than those without hypertension. MVO and IS measured as percent LV mass were not significantly different in patients with and without hypertension (adjusted differences 0.1, 95% CI -0.3 to 0.6, P = .61 and -0.2, 95% CI -1.5 to 1.2, P = .80, respectively). Hypertension was associated with a higher unadjusted risk of 1-year death (hazard ratio [HR] 2.28, 95% CI 1.44-3.60, P < .001), but was not independently associated with higher mortality after multivariable adjustment (adjusted HR 1.04, 95% CI 0.60-1.79, P = .90)., Conclusion: In this large-scale individual patient data pooled analysis, hypertension was not associated with larger IS or MVO after primary PCI for STEMI., Competing Interests: Disclosures Manesh R. Patel: Research grants—Bayer, Janssen, HeartFlow, NHLBI; advisory board/consulting: AstraZeneca, Bayer, Janssen, HeartFlow. Christopher B. Granger: Research Grants: AstraZeneca, FDA, NIH, GSK, Metronic, Novartis, Apple, Boehringer Ingelheim, BMS/ Pfizer, Janssen. Consulting: AstraZeneca, Espero, GSK, Medtronic, Novartis, Boehringer Ingelheim, Boston Scientific, BMS/ Pfizer, Daiichi Sankyo, Merck, Roche, Eli Lilly, The Medicine's Company, Janssen. E. Magnus Ohman: Research grants—Abiomed, Chiesi, Portola; consultant - Abiomed, Cara Therapeutics, Genentech, Imbria Pharmaceuticals, Impulse Dynamics, Janssen Pharmaceuticals, Medtronic, Medscape, Milestone Pharmaceuticals, XyloCor Therapeutics. Akiko Maehara: Grant support from Abbott Vascular and Boston Scientific, consultant for Conavi Medical Inc. Gregg W. Stone: Speaker honoraria from Cook, Infraredx; consultant to Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Abiomed, Ancora, Elucid Bio, Occlutech, CorFlow, Apollo Therapeutics, Impulse Dynamics, Reva, Vascular Dynamics, Shockwave, V-Wave, Cardiomech, Gore; equity/options from Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, MedFocus family of funds. The rest of the authors have no relevant conflicts of interest to disclose., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Left ventricular (LV) systolic dysfunction worsens outcomes in patients undergoing percutaneous coronary intervention (PCI). The objective of this study, therefore, was to evaluate outcomes of pLVAD-supported high-risk PCI (HRPCI) patients according to LV ejection fraction (LVEF)., Methods: Patients from the PROTECT III study undergoing pLVAD-supported HRPCI were stratified according to baseline LVEF: severe LV dysfunction (LVEF <30%), mild and moderate LV dysfunction (LVEF ≥30% to <50%), or preserved LV function (LVEF ≥50%). Major adverse cardiovascular and cerebrovascular events (MACCE: composite of all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization), and PCI-related complications were assessed at 90 days and mortality was assessed at 1-year., Results: From March 2017 to March 2020, 940 patients had evaluable baseline LVEF recorded in the study database. Patients with preserved LV function were older, more frequently presented with myocardial infarction, and underwent more left main PCI and atherectomy. Immediate PCI-related coronary complications were infrequent (2.7%, overall), similar between groups (P = 0.98), and not associated with LVEF. Unadjusted 90-day MACCE rates were similar among LVEF groups; however, as a continuous variable, LVEF was associated with both 90-day MACCE (adj.HR per 5% 0.89, 95% CI [0.80, 0.98], P = 0.018) and 1-year mortality (adj.HR per 5% 0.84 [0.78, 0.90], P <0.0001)., Conclusions: Patients who underwent pLVAD-supported HRPCI exhibited low incidence of PCI-related complications, regardless of baseline LVEF. However, LVEF was associated with 90-day MACCE and 1-year mortality., Competing Interests: Disclosures C.L. Grines reports participation on the advisory boards for Philips and Abiomed. W.B. Batchelor reports consulting for Abbott, Medtronic, Abiomed, and Boston Scientific. A.S. Bharadwaj has received consultant and speaker fees from Abiomed Inc, Cardiovascular Systems Inc and Shockwave Medical. J.W. Moses reports holding equity in Orchestra Biomed. A.G. Truesdell has received consultant and speaker fees from Abiomed, Inc. and Shockwave Medical Inc. S.J. Baron reports receiving consulting fees from Abbott, Abiomed, Edwards LifeSciences, and MitraLabs outside the submitted work as well as speaker fees from and advisory board membership with Boston Scientific. A.J. Lansky received speaker fees from Keystone Heart. M.B. Basir reports consultant fees from Abbott Vascular, Abiomed, Cardiovascular Systems, Chiesi, and Zoll. D.J. Cohen reports grant funding and consulting income from Edwards LifeSciences, Medtronic, Abbott, Boston Scientific, Philips, and CathWorks. W.W. O'Neill reports grant/research support from St. Jude Medical, Edwards Life Sciences, and Biomed; consulting fees/honoraria from Medtronic and Abiomed; and major stock shareholder/equity in Synecor, Accumed, Neovasc, Tendyne, and Mitral Align. The remaining authors report no relevant conflicts of interest., (Copyright © 2023. Published by Elsevier Inc.)

Objectives: It is unclear whether coronary artery bypass grafting (CABG) improves survival compared with medical therapy (MT) in patients with stable coronary artery disease (CAD). The aim of this analysis was to perform an individual-patient data-pooled meta-analysis of contemporary randomized controlled trials that compared CABG and MT in patients with stable CAD., Methods: A systematic search was performed in January 2021 to identify randomized controlled trials enrolling adult patients with stable CAD, randomized to CABG or MT. Only trials using at least aspirin, beta-blockers, and statins in the MT arm were included. Individual patient data were obtained from all eligible studies and pooled. The primary outcome was all-cause mortality., Results: Four trials involving 2523 patients (1261 CABG; 1262 MT) were included with a median follow-up of 5.6 (4.0-9.2) years. CABG was associated with increased risk of all-cause mortality within 30 days (hazard ratio [HR], 4.81; 95% confidence interval [CI], 1.95-11.83) but subsequent reduction in the long-term risk of death (HR, 0.79; 95% CI, 0.69-0.89). As such, the cumulative 10-year mortality rate was lower in patients treated with CABG compared with MT (45.1% vs 51.7%, respectively; odds ratio, 0.70; 95% CI, 0.58-0.85). Age and race were significant treatment effect modifier (interaction P = .003 for both)., Conclusions: In patients with stable CAD, initial allocation to CABG was associated with greater periprocedural risk of death but improved long-term survival compared with MT. The survival advantage for CABG became significant after the fourth postoperative year and was particularly pronounced in younger and non-White patients., (Copyright © 2022 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: For patients with asymptomatic, severe aortic stenosis (AS) and preserved left ventricular ejection fraction, current guidelines recommend clinical surveillance every 6 to 12 months. To date, no randomized trials have examined whether an early intervention with transcatheter aortic valve replacement (TAVR) will improve outcomes among these patients., Study Design and Objectives: EARLY TAVR is a prospective, randomized, controlled, and multicenter trial, with an event-based design. Asymptomatic severe AS patients (n = 900) are randomized 1:1 to either clinical surveillance or TAVR with the Edwards SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve. Patients are stratified by whether they are able to perform a treadmill stress test. The primary end point is death, stroke, or unplanned cardiovascular hospitalization. Patients who are asymptomatic but have a positive stress test will be followed in a registry and undergo aortic valve replacement as per current guidelines., Conclusions: EARLY TAVR is the largest randomized trial to date assessing the role of early intervention among patients with asymptomatic severe AS compared to clinical surveillance and the first to study the role of TAVR., Trial Registration Number: NCT03042104., Competing Interests: Disclosure Philippe Généreux: Abbott Vascular: Consultant, advisor, speaker fees; Abiomed: Consultant, advisor, speaker fees; Boston Scientific: Consultant; CARANX Medical: Consultant; Cardiovascular System Inc: Consultant, PI eclipse trial; Edwards LifeSciences: Consultant, advisor, speaker fees, proctor, institutional research grant, PI EARLY-TAVR trial, PI PROGRESS trial; GE Healthcare: Consultant; iRhythm technologies: Consultant; Medtronic: Consultant, advisor, speaker fees; Opsens: Consultant; Pi-Cardia: Equity, consultant; puzzle medical: equity, consultant; Saranas: Equity, consultant; Shockwave: Consultant, speaker fees; Siemens: Consultant; Soundbite Medical Inc: Equity, consultant; Teleflex: Consultant; 4C medical: Consultant, PI feasibility study. Heather Prince and Yanglu Zhao are employees of Edwards Lifesciences. David J. Cohen: Research grant support from Edwards Lifesciences, Abbott, Boston Scientific. Consulting income from Edwards Lifesciences, Abbott, Boston Scientific, Medtronic. Brian Lindman: consulting payments and investigator-initiated research grants from Edwards Lifesciences. Philippe Pibarot: Institutional funding from Edwards Lifesciences, Medtronic, Pi-Cardia, Cardiac Success, Roche Diagnostics for echocardiography core laboratory analyses, blood biomarker analyses, and research studies in the field of interventional and pharmacologic treatment of valvular heart diseases, for which he received no personal compensation. Martin B. Leon: Institutional clinical research grants from Abbott, Boston Scientific, Edwards, and Medtronic. All other authors have no disclosures., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Takotsubo syndrome (TS) is a life-threatening acute heart failure syndrome without any evidence-based treatment options. No treatment for TS has been examined in a randomized trial., Study Design and Objectives: BROKEN-SWEDEHEART is a multicenter, randomized, open-label, registry-based 2 × 2 factorial clinical trial in patients with TS designed to test whether treatment with adenosine and dipyridamole accelerates cardiac recovery and improves clinical outcomes compared to standard care (study 1); and apixaban reduces the risk of thromboembolic events compared to no treatment with antithrombotic drugs (study 2). The trial will enroll 1,000 patients. Study 1 (adenosine hypothesis) will evaluate 2 coprimary end points: (1) wall motion score index at 48 to 96 hours (evaluated in the first 200 patients); and (2) the composite of death, cardiac arrest, need for mechanical assist device or heart failure hospitalization within 30 days or left ventricular ejection fraction <50% at 48 to 96 hours (evaluated in 1,000 patients). The primary end point in study 2 (apixaban hypothesis) is the composite of death or thromboembolic events within 30 days or the presence of intraventricular thrombus on echocardiography at 48 to 96 hours., Conclusions: BROKEN-SWEDEHEART will be the first prospective randomized multicenter trial in patients with TS. It is designed as 2 parallel studies to evaluate whether adenosine accelerates cardiac recovery and improves cardiac function in the acute phase and the efficacy of anticoagulation therapy for preventing thromboembolic complications in TS. If either of its component studies is successful, the trial will provide the first evidence-based treatment recommendation in TS., Clinical Trials Identifier: The trial has been approved by the Swedish Medicinal Product Agency and the Swedish Ethical Board and is registered at ClinicalTrials.gov (NCT04666454)., (Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: Despite successful primary percutaneous coronary intervention (PCI) in ST-elevation myocardial infarction (STEMI), myocardial salvage is often suboptimal, resulting in large infarct size and increased rates of heart failure and mortality. Unloading of the left ventricle (LV) before primary PCI may reduce infarct size and improve prognosis., Study Design and Objectives: STEMI-DTU (NCT03947619) is a prospective, randomized, multicenter trial designed to compare mechanical LV unloading with the Impella CP device for 30 minutes prior to primary PCI to primary PCI alone without LV unloading. The trial aims to enroll approximately 668 subjects, with a potential sample size adaptation, with anterior STEMI with a primary end point of infarct size as a percent of LV mass evaluated by cardiac magnetic resonance at 3-5 days after PCI. The key secondary efficacy end point is a hierarchical composite of the 1-year rates of cardiovascular mortality, cardiogenic shock ≥24 hours after PCI, use of a surgical left ventricular assist device or heart transplant, heart failure, intra-cardiac defibrillator or chronic resynchronization therapy placement, and infarct size at 3 to 5 days post-PCI. The key secondary safety end point is Impella CP-related major bleeding or major vascular complications within 30 days. Clinical follow-up is planned for 5 years., Conclusions: STEMI-DTU is a large-scale, prospective, randomized trial evaluating whether mechanical unloading of the LV by the Impella CP prior to primary PCI reduces infarct size and improves prognosis in patients with STEMI compared to primary PCI alone without LV unloading., Competing Interests: Conflict of interest Dr Kapur has received research support from Abiomed, Cardiac Assist, and Maquet. and consulting fees/speaker honoraria from Abiomed, Cardiac Assist, Heartware, Maquet, and Thoratec. Dr Kim is a consultant for Abiomed. Dr Stone reports institutional research grants or contracts from Abbott, Bioventrix, Cardiovascular Systems Inc, Phillips, Biosense-Webster, Shockwave, Vascular Dynamics and V-wave; consulting fees from Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Abiomed, Ancora, Elucid Bio, Occlutech, CorFlow, Apollo Therapeutics, Impulse Dynamics, Reva, Shockwave, V-Wave, Cardiomech, Gore, and Vascular Dynamics; honoraria from Cook and Infraredx; and Stock (Equity) in Ancora, Cagent, Applied Therapeutics, Biostar Family of Funds, Spectra Wave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and MedFocus Family of Funds. Drs Ben-Yehuda and Redfors and Ms. Issever report institutional research contracts with Abiomed (no direct compensation). Dr Josephy and Dr Polak are employees of Abiomed. Dr O'Neill is a consultant to Abiomed, Boston Scientific, and Medtronic., (Copyright © 2022. Published by Elsevier Inc.)

Background: European treatment guidelines recommend prasugrel over ticagrelor for treating patients with non-ST-elevation acute coronary syndrome (ACS), prompting several Swedish administrative regions to transition from ticagrelor to prasugrel as the preferred treatment for patients with ACS. We aim to systematically evaluate this transition to determine the relative efficacy of prasugrel versus ticagrelor in a real-world cohort of patients with ACS., Study Design and Objectives: The SWITCH SWEDEHEART trial is a prospective, multicenter, open-label, cross-sectional, stepped-wedge cluster-randomized clinical trial, in which administrative regions in Sweden will constitute the clusters. At the start of the study, all clusters will use ticagrelor as the P2Y12 inhibitor drug of choice for ACS. The order in which the clusters will implement the transition from ticagrelor to prasugrel will be randomly assigned. Every 9 months, 1 cluster will switch from ticagrelor to prasugrel as the P2Y12 inhibitor of choice for patients with ACS. The primary endpoint is the composite 1-year rate of the death, stroke, or myocardial infarction., Conclusions: The SWITCH SWEDEHEART study will provide an extensive randomized comparison between ticagrelor and prasugrel. Novel therapies are frequently costly and supported by evidence from few or small studies, and systematic evaluation after the introduction is rare. This study will establish an important standard for introducing and evaluating the effects of health care changes within our societies., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Severe coronary artery calcification has been associated with stent underexpansion, procedural complications, and increased rates of early and late adverse clinical events in patients undergoing percutaneous coronary intervention. To date, no lesion preparation strategy has been shown to definitively improve outcomes of percutaneous coronary intervention for calcified coronary artery lesions., Study Design and Objectives: ECLIPSE (NCT03108456) is a prospective, randomized, multicenter trial designed to evaluate two different vessel preparation strategies in severely calcified coronary artery lesions. The routine use of the Diamondback 360 Coronary Orbital Atherectomy System is compared with conventional balloon angioplasty prior to drug-eluting stent implantation. The trial aims to enroll approximately 2000 subjects with a primary clinical endpoint of target vessel failure, defined as the composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target vessel revascularization assessed at 1 year. The co-primary endpoint is the acute post-procedural in-stent minimal cross-sectional area as assessed by optical coherence tomography in a 500-subject cohort. Enrollment is anticipated to complete in 2022 with total clinical follow-up planned for 2 years., Conclusions: ECLIPSE is a large-scale, prospective randomized trial powered to demonstrate whether a vessel preparation strategy of routine orbital atherectomy system is superior to conventional balloon angioplasty prior to implantation of drug-eluting stents in severely calcified coronary artery lesions., Competing Interests: Conflict of interest Dr Généreux: Speaker fee – Abiomed, Edwards Lifesciences, Medtronic; Shockwave, Teleflex, consultant – Abbott Vascular, Abiomed, Boston Scientific, Cardiovascular System Inc, Cordis, Edwards Lifesciences, iRythm, Medtronic, Opsens, Pi-Cardia, Saranas, Siemens Healthcare, SIG.NUM, Soundbite Medical Solutions Inc. Teleflex; 4C Medical, Equity/options – Pi-Cardia, Puzzle Medical, Saranas, SIG.NUM, Soundbite Medical. Dr Kirtane: Institutional funding to Columbia University and/or Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, ReCor Medical. In addition to research grants, institutional funding includes fees paid to Columbia University and/or Cardiovascular Research Foundation for speaking engagements and/or consulting. Personal: Consulting – Neurotronic; travel expenses/meals from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron. Dr Kandzari: Institutional research/grant support – Abbott Vascular, Biotronik, Boston Scientific, Cardiovascular Systems, Medtronic, Teleflex; personal consulting honoraria – Cardiovascular Systems, Medtronic. Dr Armstrong: Consultant for Abbott Vascular, Boston Scientific, Cardiovascular Systems Inc, Intact Vascular, Gore, Medtronic, Philips, and Shockwave. Dr Krucoff: Consulting/speaker fee: Abbott Vascular, Biosensors, Boston Scientific, Cardiovascular System Inc, Medtronic, OrbusNeich, SMT, Terumo; Research grants: Abbott Vascular, Biosensors, Boston Scientific, Cardiovascular System Inc, Medtronic, OrbusNeich, SMT, Terumo, Cook, Gore. Dr Lerew: Employee – Cardiovascular Systems, Inc. Dr Ali: Institutional research grants to Columbia University – Abbott, Cardiovascular Systems Inc; consultant – Amgen, AstraZeneca, Boston Scientific.; equity – Shockwave. Dr Maehara: Grant support and consultant - Abbott Vascular and Boston Scientific. Dr O'Neill: Consultant - Edwards Lifesciences, Abbott, and Boston Scientific. Dr Stone: Speaker or other honoraria from Cook and Terumo; Consultant to Valfix, TherOx, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions, Miracor, Neovasc, V-Wave, Abiomed, Ancora, MAIA Pharmaceuticals, Vectorious, Reva, Matrizyme, Cardiomech, Elucid Bio, Occlutech; Equity/options from Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, MedFocus family of funds, Valfix. Other authors: None., (Copyright © 2022. Published by Elsevier Inc.)

Background: The purpose of this study is to investigate the impact of oxygen therapy on cardiovascular outcomes in relation to sex in patients with confirmed myocardial infarction (MI)., Methods: The DETermination of the role of Oxygen in suspected Acute Myocardial Infarction trial randomized 6,629 patients to oxygen at 6 L/min for 6-12 hours or ambient air. In the present subgroup analysis including 5,010 patients (1,388 women and 3,622 men) with confirmed MI, we report the effect of supplemental oxygen on the composite of all-cause death, rehospitalization with MI, or heart failure at long-term follow-up, stratified according to sex., Results: Event rate for the composite endpoint was 18.1% in women allocated to oxygen, compared to 21.4% in women allocated to ambient air (hazard ratio [HR] 0.83, 95% confidence interval [CI] 0.65-1.05). In men, the incidence was 13.6% in patients allocated to oxygen compared to 13.3% in patients allocated to ambient air (HR 1.03, 95% CI 0.86-1.23). No significant interaction in relation to sex was found (P= .16). Irrespective of allocated treatment, the composite endpoint occurred more often in women compared to men (19.7 vs 13.4%, HR 1.51; 95% CI, 1.30-1.75). After adjustment for age alone, there was no difference between the sexes (HR 1.06, 95% CI 0.91-1.24), which remained consistent after multivariate adjustment., Conclusion: Oxygen therapy in normoxemic MI patients did not significantly affect all-cause mortality or rehospitalization for MI or heart failure in women or men. The observed worse outcome in women was explained by differences in baseline characteristics, especially age., (Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.)

Objectives: Not all patients in need of durable mechanical circulatory support are suitable for a continuous-flow left ventricular assist device. We describe patient populations who were treated with the paracorporeal EXCOR, including children with small body sizes, adolescents with complex congenital heart diseases, and adults with biventricular failure., Methods: Information on clinical data, echocardiography, invasive hemodynamic measurements, and surgical procedures were collected retrospectively. Differences between various groups were compared., Results: Between 2008 and 2018, a total of 50 patients (21 children and 29 adults) received an EXCOR as bridge to heart transplantation or myocardial recovery. The majority of patients had heart failure compatible with Interagency Registry for Mechanically Assisted Circulatory Support profile 1. At year 5, the overall survival probability for children was 90%, and for adults 75% (P = .3). After we pooled data from children and adults, the survival probability between patients supported by a biventricular assist device was similar to those treated with a left ventricular assist device/ right ventricular assist device (94% vs 75%, respectively, P = .2). Patients with dilated cardiomyopathy had a trend toward better survival than those with other heart failure etiologies (92% vs 70%, P = .05) and a greater survival free from stroke (92% vs 64%, P = .01). Pump house exchange was performed in nine patients due to chamber thrombosis (n = 7) and partial membrane rupture (n = 2). There were 14 cases of stroke in eleven patients., Conclusions: Despite severe illness, patient survival on EXCOR was high, and the long-term overall survival probability following heart transplantation and recovery was advantageous. Treatment safety was satisfactory, although still hampered by thromboembolism, mechanical problems, and infections., (Copyright © 2020 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: New onset of left ventricular (LV) dysfunction in organ donors is frequent and considered as a contraindication for utilization of the heart. However, such dysfunction might be caused by sympathetic stress and could be transient (Takotsubo syndrome). In this study, we assessed the incidence, pattern, and predictors of LV dysfunction in potential heart donors and evaluated its influence on recipient outcomes., Methods: Donor records of consecutive organ donors in western Sweden between 2006 and 2016 were reviewed. Recipients of transplanted donor hearts were identified in the Scandiatransplant database., Results: Of 641 potential heart donors who underwent echocardiographic assessment, LV dysfunction (ejection fraction <50% and/or regional hypokinesia) was found in 155 donors (24%). Regional hypokinesia was seen in 113 donors of whom 46 had a Takotsubo-like circumferential hypokinetic pattern. Independent donor variables associated with LV dysfunction were a younger age, cardiac arrest as a contributing factor to death, need for inotropic support, and a shorter time from admission to declaration of brain death. A total of 338 (54%) donor hearts were transplanted, of which 45 (14%) had LV dysfunction. LV dysfunction was a major determinant of not transplanting the heart (P < .001). After transplantation, LV function normalized in the recipients. Neither short-term outcomes nor the composite end point of death or retransplantation over time differed between recipients of donor hearts with versus without LV dysfunction (P = .587)., Conclusions: LV dysfunction is common among potential heart donors. These hearts were safely transplanted in this study. The use of these hearts might significantly increase transplantation rates., (Copyright © 2019 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Drug-eluting stents (DESs) have improved clinical outcomes of patients undergoing percutaneous coronary intervention (PCI). Nevertheless, adverse events related to previously treated lesion still occur. We sought to evaluate the incidence and predictors of target lesion failure (TLF) in patients undergoing contemporary DES implantation., Methods: Patient-level data from 6 prospective, randomized trials were pooled, and DES treatment outcomes were analyzed at up to 5 years. Primary outcome was TLF (cardiac death, target lesion revascularization, or target vessel myocardial infarction). Cox proportional-hazards model was used to identify predictors of TLF., Results: Overall, 10,072 patients were included in the analysis. TLF rate was 1.7%, 4.3%, and 11.9% at 30 days, 1 year, and 5 years, respectively. The only independent predictor of TLF at 30 days was stent length (hazard ratio [HR] 1.017, 95% CI 1.011-1.024, P < .0001). Moderate/severe calcification, stent length and post procedural diameter sthenosis were predictors between 30 days to 1 year but not at 1 to 5 years. Reference vessel diameter was the only lesion-related predictor at 5 years (P = .003). Clinical predictors of TLF between 30 days and 1 year were diabetes and hypertension (P < .01 for both), and between 1 and 5 years, diabetes (HR 1.40, 95% CI 1.13-1.73, P = .002), prior coronary artery bypass grafting (HR 2.52, 95% CI 1.92-3.30, P < .0001), and prior PCI (HR 1.29, 95% CI 1.02-1.64, P = .04) predicted TLF., Conclusions: Predictors of TLF vary in the early, late, and very late postprocedural periods. Reference vessel diameter was the only lesion-related predictor of long-term TLF; clinical predictors were diabetes, prior coronary artery bypass grafting, and prior PCI., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) typically requires a greater number of stents and longer stent length than non-CTO PCI, placing these patients at greater risk for adverse ischemic events. We sought to determine whether the association between high platelet reactivity (HPR) and the risk of ischemic events is stronger after CTO than non-CTO PCI., Methods: Patients undergoing successful PCI in the multicenter ADAPT-DES study were stratified according to whether they underwent PCI of a CTO. HPR was defined as VerifyNow platelet reaction units >208. The study primary endpoint was the 2-year risk target vessel failure ([TVF] defined as cardiac death, myocardial infarction, or target lesion revascularization)., Results: CTO PCI was performed in 400 of 8448 patients. HPR was present in 34.5% of CTO PCI patients and 43.1% of non-CTO PCI patients (P = .0007). Patients undergoing CTO PCI with versus without HPR had significantly higher 2-year rates of TVF (15.0% versus 8.3%, P = .04) without significant differences in bleeding. HPR was an independent predictor of 2-year TVF (adjusted HR 1.16, 95% CI 1.02-1.34, P = .03) whereas CTO PCI was not (adjusted HR 0.89, 95% CI 0.65-1.22, P = .48). There was a significant interaction between CTO versus non-CTO PCI and PRU as a continuous variable for 2-year TVF (P interaction = 0.02)., Conclusions: In ADAPT-DES, HPR was associated with an increased 2-year risk of TVF after PCI, an association that was at least as strong after CTO PCI compared with non-CTO PCI., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: The prognostic impact of high-sensitivity C-reactive protein (CRP) levels in patients with left main coronary artery disease (LMCAD) treated with percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) is unknown. We sought to determine the effect of elevated baseline CRP levels on the 3-year outcomes after LMCAD revascularization and to examine whether CRP influenced the relative outcomes of PCI versus CABG., Methods: In the EXCEL trial, patients with LMCAD and Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) scores ≤32 were randomized to PCI versus CABG. The primary composite outcome of death, myocardial infarction (MI), or stroke was analyzed according to baseline CRP levels., Results: Among 999 patients with available CRP levels, median CRP was 3.10 mg/L (interquartile range 1.12-6.40 mg/L). The rate of the primary composite end point of death, MI, or stroke at 3 years steadily increased with greater baseline CRP levels. The adjusted relationship between the 3-year composite rate of death, MI, or stroke and baseline CRP modeled as a continuous log-transformed variable demonstrated steadily increasing event rates with greater CRP levels (adjusted hazard ratio, 1.26, 95% CI 1.10-1.44, P = .0008). Similarly, patients with CRP ≥10 mg/L had a 3-fold higher risk of the 3-year primary end point compared to patients with lower CRP levels (adjusted hazard ratio 2.92, 95% CI 1.88-4.54, P < .0001). The association between an elevated CRP level and the adjusted 3-year risk of the primary composite end point did not differ according to revascularization strategy (P interaction = .75)., Conclusions: In patients with LMCAD undergoing revascularization, elevated baseline CRP levels were strongly associated with subsequent death, MI, and stroke at 3 years, irrespective of the mode of revascularization. Further studies are warranted to determine whether anti-inflammatory therapies may improve the prognosis of high-risk patients with LMCAD following revascularization., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: There is a paucity of data from large contemporary cohorts of patients with in-stent restenosis (ISR) treated with drug-eluting stents (DESs), and no studies have examined the impact of high platelet reactivity (HPR) on the occurrence of ischemic events after ISR percutaneous coronary intervention (PCI) with DESs. We sought to report outcomes after PCI of ISR lesions and its association with HPR., Methods: Patients in the prospective, multicenter ADAPT-DES study were stratified according to whether they had ISR versus non-ISR PCI. Two-year outcomes were compared between the groups using Cox proportional hazards models. HPR was defined as on-clopidogrel P2Y12 platelet reaction units >208 as measured by the VerifyNow assay; target vessel failure (TVF) was defined as the composite of all-cause death, myocardial infarction, or ischemia-driven target vessel revascularization., Results: Among the 8,582 patients included in the ADAPT-DES study, 840 (9.8%) patients underwent successful ISR PCI. ISR PCI was independently associated with a higher 2-year risk of TVF (adjusted hazard ratio [HR] 1.95; 95% CI 1.68-2.27; P<.001) and stent thrombosis (adjusted HR 1.95; 95% CI 1.08-3.51; P=.027) but not bleeding (adjusted HR 0.94; 95% CI 0.73-1.21; P=.64). There was no statistical interaction between HPR and ISR versus non-ISR PCI in regard to TVF (adjusted P interaction =.81)., Conclusions: ISR PCI is associated with a considerably higher risk of 2-year adverse ischemic events, with HPR conferring similar risk in ISR and non-ISR PCI. More effective therapeutic strategies for managing ISR lesions are necessary., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Objective: Right ventricular failure in patients treated using left ventricular assist devices is associated with poor outcomes. We assessed the strategy of preplanned biventricular assist device implantation in patients with a high risk for right ventricular failure., Methods: Between 2010 and 2014, we assigned 20 patients to preplanned biventricular assist device and 21 patients to left ventricular assist device as a bridge to heart transplantation on the basis of the estimated risk of postimplant right ventricular failure. Preimplant characteristics and postimplant outcomes were compared between the 2 groups., Results: Patients with a biventricular assist device were younger, more often female, and more frequently had nonischemic heart disease than left ventricular assist device recipients. At preoperative assessment, biventricular assist device recipients had poorer Interagency Registry for Mechanically Assisted Circulatory Support profiles, a lower cardiac index, and more compromised right ventricular function. Survival on device to heart transplantation/weaning/destination for biventricular assist device and left ventricular assist device recipients was 90% versus 86% (not significant), with shorter heart transplantation waiting times for biventricular assist device recipients (median days, 154 vs 302, P < .001). Overall survival at 1 year was 85% (95% confidence interval, 62-95) versus 86% (95% confidence interval, 64-95) (not significant). The majority of both biventricular assist device and left ventricular assist device recipients could be discharged to home during the heart transplantation waiting time (55% vs 71%, not significant), and complication rates on device were comparable between groups (major stroke 10% vs 10%, not significant)., Conclusions: Planned in advance, the biventricular assist device seems to be a feasible option as bridge to heart transplantation for patients with a high risk of postimplant right ventricular failure. The outcomes for these patients were similar to those observed for contemporary left ventricular assist device recipients, despite those receiving biventricular assist devices being more severely ill., (Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)