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BACKGROUND: This is the first study to examine the effect of acute (24-hour) beta-blocker withholding on ventilatory efficiency in patients with advanced chronic heart failure (CHF) during maximal incremental treadmill cardiopulmonary exercise test. METHODS AND RESULTS: Seventeen CHF patients were studied either 3 hours after administration of beta-blocker (BB(ON)) or 27 hours after the last beta-blocker ingestion (BB(OFF)). The ventilatory efficiency was measured via the slope of the linear relationship between ventilation (V'(E)) and carbon dioxide production (V'CO2) (ie, V'(E)/V'CO2 slope). Measurements were also made at rest, anaerobic threshold (AT), maximal end-tidal pressure for carbon dioxide (P(ET)CO2max), respiratory compensation point (RC), and peak exercise. Compared with BB(ON), the V'(E)/V'CO2 slope was significantly increased during BB(OFF) (30.8 +/- 7.4 vs. 29.1 +/- 5.4, P = .04). At peak exercise, oxygen uptake (V'O2, 16.0 +/- 2.7 vs. 15.6 +/- 2.8 mL x kg x min) and V'CO2 (1458 +/- 459 vs. 1414 +/- 429 mL/min) were not different between the 2 conditions, whereas V'(E) was higher during BB(OFF) (49.5 +/- 10.7 vs. 46.1 +/- 9.6 L/min, P = .04). No differences were noted at AT and RC in V'O2, V'CO2, V'(E), V'(E)/V'O2, and V'(E)/V'CO2 ratios during the 2 conditions. At P(ET)CO2max, used to noninvasively estimate the CO2 set point, V'(E) was higher (33.9 +/- 7.6 vs. 31.7 +/- 7.3 L/min, P = .002) and P(ET)CO2 was lower (37.4 +/- 4.8 vs. 38.5 +/- 4.0 mm Hg, P = .03), whereas V'CO2 was unchanged (1079 +/- 340 vs. 1050 +/- 322 mL/min) during BB(OFF). CONCLUSION: Acute beta-blocker withholding resulted in decreased ventilatory efficiency mostly from an increase of V'CO2-independent regulation of V'(E) and less likely from a change in ventilation/perfusion mismatching. [ABSTRACT FROM AUTHOR]

Background: Percutaneous microaxial ventricular assist devices (pVAD) have the potential to reduce mortality of patients with cardiogenic shock (CS). However, the association between the distribution of pVAD-performing centers and outcomes of CS has not been explored. Methods: This observational study included Medicare fee-for-service beneficiaries aged 65-99 years treated with pVAD for CS from 2016 to 2020 and examined the associations between patient outcomes and two exposure variables: hospitals' procedure volumes of pVAD and patient-hospital distances (in quintiles [Qn]). We developed Cox proportional hazard regression for 180-day mortality and heart failure (HF) readmission rates and multivariable logistic regression for in-hospital outcomes, adjusting for patient demographics, comorbidities, concomitant treatments, and hospital characteristics, including CS volume, teaching status, and the ability to perform extracorporeal membrane oxygenation. Results: A total of 6,637 patients with CS underwent pVAD at 1,041 hospitals, with the annualized hospital volume ranging widely from 0.3 to 55.6 cases/year. Patients treated at higher-volume centers experienced lower 180-day mortality compared with patients treated at lower-volume centers (Qn1=reference; Qn2: adjusted hazard ratio [aHR], 0.88; 95% confidence interval [CI], 0.79-0.97; Qn3: aHR, 0.88; 95% CI, 0.79-0.98; Qn4: aHR, 0.88; 95% CI, 0.78-0.99; Qn5: aHR, 0.84; 95% CI, 0.74-0.95; p-for-trend, 0.026), while we found no evidence that patient-hospital distances were associated with mortality (Qn1=reference; Qn2: adjusted hazard ratio [aHR], 0.99; 95% confidence interval [CI], 0.89-1.09; Qn3: aHR, 0.94; 95% CI, 0.85-1.04; Qn4: aHR, 1.01; 95% CI, 0.92-1.11; Qn5: aHR, 0.91; 95% CI, 0.82-1.01; p-for-trend, 0.160). We found no evidence that the hospital volume and patient-hospital distances were associated with in-hospital bleeding, intracranial hemorrhage, or renal replacement therapy initiation. Conclusions: Hospital volume was more strongly associated with mortality than patient-hospital distances, suggesting that rational distribution of pVAD-performing centers while ensuring adequate procedure volumes may optimize patient mortality.

Background: Tricuspid regurgitation (TR) is a right-sided valvular disease independently associated with morbidity and mortality. The TRILUMINATE Pivotal trial is the first randomized, controlled trial assessing the impact of TR reduction with tricuspid transcatheter edge-to-edge repair (T-TEER)., Objective: Outcomes from the full randomized cohort of the TRILUMINATE Pivotal trial have not been previously reported, and the additional enrollment may further support the safety and effectiveness of T-TEER through 1 year., Methods: The TRILUMINATE Pivotal trial is an international RCT of T-TEER with the TriClip device in patients with symptomatic, severe TR. Adaptive trial design allowed enrollment past the primary analysis population. The primary outcome was a hierarchical composite of all-cause mortality or tricuspid valve surgery, heart failure hospitalizations (HFH), and quality-of-life improvement measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 1 year., Results: Between August 21, 2019 and June 29, 2022, 572 subjects were randomized, including the primary cohort (n=350) and subsequent enrollment (n=222). Subjects were elderly (78.1±7.8 years) and predominantly female (58.9%), with atrial fibrillation (87.8%) and prior HFH (23.8%). The primary endpoint was met for the full cohort (win ratio=1.84, p<0.0001). Freedom from all-cause mortality and tricuspid valve surgery through 12 months was 90.6% and 89.9% for the device and control groups, respectively (p=0.82). Annualized HFH rate was comparable between device and control subjects (0.17 vs 0.20 events/patient-year, p=0.40). A significant treatment effect was observed for change in quality of life with 49.5% of device subjects achieving a ≥15-point KCCQ score improvement (compared to 25.6% of control subjects, p<0.0001). All secondary endpoints favored T-TEER: moderate or less TR at 30 days (88.9% vs 5.3%, p<0.0001), KCCQ change at 1 year (13.0±1.4 vs -0.5±1.4 points, p<0.0001), and six-minute walk distance change at 1 year (1.7±7.5 vs -27.4±7.4 meters, p<0.0001). Freedom from major adverse events was 98.9% for T-TEER (vs. performance goal: 90%, p<0.0001)., Conclusions: TriClip was safe and effective in the full randomized cohort of TRILUMINATE Pivotal with significant TR reduction and improvements in six-minute walk distance and health status. Rates of all-cause mortality or TV surgery and HFH through 1 year were not reduced by T-TEER., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Peak oxygen uptake (pVO 2 ) predicts mortality in patients with heart failure on left ventricular assist device (LVAD) support. This follow-up of the PRO-VAD study examines the prognostic value of repeated pVO 2 measurements during long-term follow-up., Methods: This multicenter follow-up study included patients from the original PRO-VAD cohort who performed a cardiopulmonary exercise test (CPET) twice. Patients were categorized into 4 groups based on pVO 2 levels at the 2 CPETs: low at both tests, low at the first and high at the second test, high at the first and low at the second test, and high at both tests. Low pVO 2 was defined as ≤14 ml/kg/min (or ≤12 ml/kg/min if beta-blocker tolerant), while values above these thresholds were considered high. Survival outcomes were analyzed using the Kaplan-Meier method and cause-specific Cox analysis., Results: The study included 152 patients with repeated CPETs at approximately 6 and 12 months following LVAD implantation. The cohort showed slight but significant pVO 2 improvement (median change: 0.4 ml/kg/min, p = 0.04). Persistently high pVO 2 (76 patients) was associated with a 5-fold reduction in mortality hazard (hazard ratio [HR] 0.20, p = 0.002), compared with persistently low pVO 2 (46 patients). Improvement from low to high pVO 2 (21 patients) displayed similar benefits (HR 0.21, p = 0.02)., Conclusions: pVO 2 measurements remain predictive of mortality upon reiteration in patients with LVAD, with changes in pVO 2 providing additional prognostic value in identifying patients with an excellent outcome on ongoing LVAD support and in identifying patients requiring further interventions., (Copyright © 2024 International Society for the Heart and Lung Transplantation. All rights reserved.)

Unilateral pulmonary edema (UPE) is a rare manifestation of cardiogenic pulmonary edema that is often confused with other causes of unilateral pulmonary infiltrates. A 47-year-old female with a HeartWare left ventricular assist device (LVAD) presented with dyspnea and UPE. Right heart catheterization revealed inadequate left ventricular unloading in the setting of aortic insufficiency and facilitated LVAD speed adjustment leading to resolution of symptoms. Timely diagnosis of UPE is critical because it is related to an independent increased risk of mortality, likely due to initial misdiagnosis and delayed proper treatment. The increasing use of LVADs in patients with advanced heart failure necessitates a thorough understanding of potential device complications and their management., Competing Interests: The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2024 The Authors.)

Microvascular dysfunction (MVD) is considered a form of cardiac allograft vasculopathy (CAV), independently associated with poor prognosis after heart transplantation (HTX). It is unknown whether traditional risk factors for CAV are also applicable to MVD. We retrospectively analyzed factors associated with MVD in 94 HTX recipients who completed a PET scan after a normal baseline left heart catheterization excluding epicardial CAV. MVD was defined by abnormal PET blood flow. The mean age was 52 ± 14 and MVD was found in 49 patients (53%). No donor risk factors were significantly associated with recipient MVD. Recipients risk factors for MVD included-diabetes mellitus (51% vs. 27%, p = 0.016) and hypertension (78% vs. 49%, p = 0.004) in patients with and without MVD, respectively. In a multivariate model, recipient hypertension and diabetes were the only significant determinants of MVD development (OR = 2.63, 95% CI [1.69-36.98], p = 0.009 and OR 2.1, 95% CI [1.10-15.38], p = 0.035, respectively). In conclusion, MVD was more associated with metabolic risk determinants rather than traditional CAV risk factors., (© 2024 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Despite a record setting number of heart transplants performed annually, the national donor shortage continues to plague transplant teams across the United States. Here we describe the barriers to adaptation of numerous "non-traditional" orthotopic heart transplant donor characteristics including donors with hepatitis C virus, those meeting criteria for donation after cardiac death, donors with coronavirus disease 19 infection, donors with the human immunodeficiency virus, and grafts with left ventricular systolic dysfunction. Our center's objective was to increase our transplant volume by expanding our donor pool from "traditional" donors to these "non-traditional" donors. We detail how medical advances such as certain laboratory studies, pharmacologic interventions, and organ care systems have allowed our center to expand the donor pool thereby increasing transplantation volume without adverse effects on outcomes., Competing Interests: Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article., (©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.)

Background: The TRILUMINATE Pivotal trial is a prospective, randomized, controlled study of patients with severe tricuspid regurgitation (TR). Venous congestion due to TR may lead to end-organ dysfunction and failure. The potential to reverse or stop further deterioration in end-organ function is an important goal of treatment., Objectives: This study sought to examine changes in end-organ function after tricuspid transcatheter edge-to-edge repair (TEER) and assess the association of baseline end-organ function with heart failure (HF) hospitalizations and mortality., Methods: Subjects were randomized 1:1 to either the TEER group (TriClip System + medical therapy) or control group (medical therapy alone). Laboratory assessments and TR grading were performed at baseline and at all follow-up visits (discharge, 30 days, 6 months, and 12 months). An independent echocardiography core laboratory assessed TR severity and an independent clinical events committee adjudicated adverse events., Results: A total of 572 subjects were enrolled and randomized (285 TEER, 287 control patients). Patients with moderate-to-severe end-organ impairment (estimated glomerular ejection fraction [eGFR] <45 mL/min/1.73 m 2 or Model for End-Stage Liver Disease excluding INR [MELD-XI] >15) at baseline had increased incidence of HF hospitalization and death through 12 months, regardless of treatment. There were no statistically significant differences between TEER and control patients in eGFR or MELD-XI at 12 months. In subgroup analyses examining only successful TEER patients (moderate or less TR at discharge) compared with control patients, as well as when censoring patients with normal baseline values, both eGFR (+3.55 ± 1.04 mL/min/1.73 m 2 vs 0.07 ± 1.10 mL/min/1.73 m 2 ; P = 0.022) and MELD-XI (-0.52 ± 0.18 vs 0.34 ± 0.18; P = 0.0007) improved., Conclusions: Baseline end-organ function was associated with HF hospitalization and death in patients with severe TR. At 12 months, eGFR and MELD-XI scores were not statistically significantly different between the overall TEER and control groups. In patients who had successful TEER, statistically significant, yet small, favorable changes occurred for both eGFR and MELD-XI. Further investigation is needed to assess whether these changes in end-organ function after successful TEER are clinically meaningful and reduce HF hospitalization or death. (Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System Pivotal [TRILUMINATE Pivotal]; NCT03904147)., Competing Interests: Funding Support and Author Disclosures The TRILUMINATE Pivotal trial was funded and sponsored by Abbott. Dr Jorde has received consulting fees from Abbott and Edwards Lifesciences. Dr Benza has received consulting fees from Abbott and Bayer HealthCare Pharmaceuticals Inc; and has been an endpoint review committee member for United Therapeutics. Dr McCarthy has been a coprincipal investigator of REPAIR-MR (unpaid) for Abbott; has served on advisory boards for Abbott and egnite; has received royalties from Edwards Lifesciences; and has received speaker fees from Medtronic, Edwards Lifesciences, and Atricure. Dr Ailawadi has received consulting fees from Abbott, Edwards Lifesciences, and Medtronic. Dr Whisenant has received consulting fees from Abbott and Edwards Lifesciences. Dr Makkar has received grants and institutional research support from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; has received consulting fees from Cordis Corporation and Medtronic; and has performed unpaid trial activities for Abbott, Boston Scientific, and Edwards Lifesciences. Dr Tadros has received consulting fees from Abbott and Edwards Lifesciences. Dr Naik has received consulting fees from Abbott, Boston Scientific, and Edwards Lifesciences. Dr Fam has received consulting fees from Abbott. Dr Sauer has received grants and institutional research support from Saint Luke’s Mid America Heart Institute, Bayer, CSL Vifor, Pfizer, Rivus, AstraZeneca, Novo Nordisk, Impulse Dynamics, 35Pharma, Abbott, Boston Scientific, General Prognostics, Acorai, Story Health, and Amgen; and has received honoraria for speaking or advising from Bayer, CSL Vifor, Abbott, Impulse Dynamics, Boston Scientific, Edwards Lifesciences, Acorai, Story Health, and General Prognostics. Dr Kar has received consulting fees from Abbott, Boston Scientific, InterShunt, Medtronic, Peija, V-Wave, W.L. Gore, and Medtronic; and has served as co-principal investigator of the EXPAND and REPAIR MR trials for Abbott. Dr von Bardeleben has performed unpaid trial activities for Abbott, Edwards Lifesciences, and University of Göttingen (IIT); and has served on advisory boards or speakers bureaus for Abbott, Bioventrix, Boston Scientific, Cardiac Dimensions, Edwards Lifesciences, and NeoChord. Dr Hahn has received speaker fees from Abbott, Baylis Medical Company Inc, Edwards Lifesciences, Medtronic, and Philips. Dr Hamid has received consulting fees from 4C Medical Technologies, Inc, Alleviant Medical, Inc, AMX, Anteris Technologies Corporation, Edwards Lifesciences, Philips, Valcare Med Ltd, VDyne, and W.L. Gore & Associates, Inc. Dr Zbinden has been a senior clinical scientist for Abbott. Dr Sorajja is co-principal investigator for the TRILUMINATE Pivotal trial; has served on advisory boards for Anteris Technologies and VDyne; and has received consulting fees from Boston Scientific, Edwards Lifesciences, Evolution Medical, Medtronic, Shifamed, TriFlo, and W.L. Gore & Associates, Inc. Dr Adams is co-principal investigator for the TRILUMINATE Pivotal trial; and receives royalties from Edward Lifesciences and Medtronic. Dr Murthy has reported that she has no relationships relevant to the contents of this paper to disclose., (Copyright © 2024. Published by Elsevier Inc.)

Introduction: Donation after circulatory death (DCD) donors are becoming an important source of organs for heart-transplantation (HT), but there are limited data regarding their use in multiorgan-HT., Methods: Between January 2020 and June 2023, we identified 87 adult multiorgan-HTs performed using DCD-donors [77 heart-kidney, 6 heart-lung, 4 heart-liver] and 1494 multiorgan-HTs using donation after brain death (DBD) donors (1141 heart-kidney, 165 heart-lung, 188 heart-liver) in UNOS. For heart-kidney transplantations (the most common multiorgan-HT combination from DCD-donors), we also compared donor/recipient characteristics, and early outcomes, including 6-month mortality using Kaplan-Meier (KM) and Cox hazards-ratio (Cox-HR)., Results: Use of DCD-donors for multiorgan-HTs in the United States increased from 1% in January to June 2020 to 12% in January-June 2023 (p < 0.001); but there was a wide variation across UNOS regions and center volumes. Compared to recipients of DBD heart-kidney transplantations, recipients of DCD heart-kidney transplantations were less likely to be of UNOS Status 1/2 at transplant (35.06% vs. 69.59%) and had lower inotrope use (22.08% vs. 43.30%), lower IABP use (2.60% vs. 26.29%), but higher durable CF-LVAD use (19.48% vs. 12.97%), all p < 0.01. Compared to DBD-donors, DCD-donors used for heart-kidney transplantations were younger [28(22-34) vs. 32(25-39) years, p = 0.004]. Recipients of heart-kidney transplantations from DCD-donors and DBD-donors had similar 6-month survival using both KM analysis, and unadjusted and adjusted Cox-HR models, including in propensity matched cohorts. Rates of PGF and in-hospital outcomes were also similar., Conclusions: Use of DCD-donors for multiorgan-HTs has increased rapidly in the United States and early outcomes of DCD heart-kidney transplantations are promising., (© 2024 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Objectives: The Durable Mechanical Circulatory Support System After Extracorporeal Life Support registry is a multicenter registry of patients who were bridged from extracorporeal life support to a durable mechanical circulatory support system. Although numerous studies have highlighted the favorable outcomes after implantation of the HeartMate 3 (Abbott), the objective of our study is to examine the outcomes of patients who received HeartMate 3 support after extracorporeal life support., Methods: Data of patients undergoing HeartMate 3 implantation from January 2016 to April 2022 at 14 centers were collected and evaluated. Inclusion criteria were patients with extracorporeal life support before HeartMate 3 implantation. The outcome was reported and compared with patients receiving other types of pumps., Results: A total of 337 patients were bridged to durable mechanical circulatory support system after extracorporeal life support in the study period. Of those patients, 140 were supported with the HeartMate 3. The other types of pumps included 170 HeartWare HVADs (Medtronic) (86%), 14 HeartMate II devices (7%), and 13 (7%) other pumps (7%). Major postoperative complications included right heart failure requiring temporary right ventricular assist device in 60 patients (47%). Significantly lower postoperative stroke (16% vs 28%, P = .01) and pump thrombosis (3% vs 8%, P = .02) rates were observed in the patients receiving the HeartMate 3. The 30-day, 1-year, and 3-year survivals in patients receiving the HeartMate 3 were 87%, 73%, and 65%, respectively., Conclusions: In this critically ill patient population, the survivals of patients who were transitioned to the HeartMate 3 are deemed acceptable and superior to those observed when extracorporeal life support was bridged to other types of durable mechanical circulatory support systems., Competing Interests: Conflict of Interest Statement The authors reported no conflicts of interest. The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling or reviewing manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest., (Copyright © 2023 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Orthotopic heart transplant is the gold standard therapeutic intervention for patients with end-stage heart failure. Conventionally, heart transplant has relied on donation after brain death for organ recovery. Donation after circulatory death (DCD) is the donation of the heart after confirming that circulatory function has irreversibly ceased. DCD-orthotopic heart transplant differs from donation after brain death-orthotopic heart transplant in ways that carry implications for widespread adoption, including differences in organ recovery, storage and ethical considerations surrounding normothermic regional perfusion with DCD. Despite these differences, DCD has shown promising early outcomes, augmenting the donor pool and allowing more individuals to benefit from orthotopic heart transplant. This review aims to present the current state and future trajectory of DCD-heart transplant, examine key differences between DCD and donation after brain death, including clinical experiences and innovations in methodologies, and address the ongoing ethical challenges surrounding the new frontier in heart transplant with DCD donors., Competing Interests: Dr Jorde is a consultant for Abbott. Dr Goldstein is a consultant for Abbott Inc and a consultant and speaker for Abiomed Inc.

We introduce the innovative use of technetium-99m-labeled macroaggregated albumin to diagnose high-output heart failure in a patient with multiple myeloma with persistent congestion symptoms. Symptom resolution occurred with lenalidomide and steroids. This marks the first clinical use of technetium-99m-labeled macroaggregated albumin for clarifying high-output heart failure etiology., Competing Interests: The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2024 The Authors.)

Background: The HeartMate 3 (HM 3; Abbott) left ventricular assist device (LVAD) has improved hemocompatibility-related adverse outcomes. In sporadic cases, external compression of the outflow graft causing obstruction (eOGO) can result from substance accumulation between the outflow graft and its bend relief. We sought to evaluate the prevalence, course, and clinical implications of eOGO in an international study., Methods: A multicenter retrospective analysis of HM 3 LVADs implanted between November 2014 and April 2021 (n = 2108) was conducted across 17 cardiac centers in 8 countries. We defined eOGO as obstruction >25% in the cross-sectional area in imaging (percutaneous angiography, computed tomography, or intravascular ultrasound). The prevalence and annual incidence were calculated. Serious adverse events and outcomes (death, transplantation, or device exchange) were analyzed for eOGO cases., Results: Of 2108 patients, 62 were diagnosed with eOGO at a median LVAD support duration of 953 (interquartile range, 600-1267) days. The prevalence of eOGO was 3.0% and the incidence at 1, 2, 3, 4, and 5 years of support was 0.6%, 2.8%, 4.0%, 5.2%, and 9.1%, respectively. Of 62 patients, 9 were observed, 27 underwent surgical revision, 15 underwent percutaneous stent implantation, 8 received a heart transplant, and 2 died before intervention. One patient underwent surgical revision and later stent implantation. The mortality with therapeutic intervention was 9/53 (17.0%)., Conclusions: Although uncommon, HM 3 LVAD-supported patients might develop eOGO with an increasing incidence after 1 year of support. Although engineering efforts to reduce this complication are under way, clinicians must maintain a focus on early detection and remain vigilant., (Copyright © 2022 The American Association for Thoracic Surgery. All rights reserved.)

Primary graft dysfunction (PGD) after cardiac transplantation is a devastating complication with increasing frequency lately in the setting of donation after circulatory death (DCD). Severe PGD is commonly treated with extracorporeal membrane oxygenation (ECMO) using central or peripheral cannulation. We retrospectively reviewed the outcomes of PGD after cardiac transplantation requiring ECMO support at our center from 2015 to 2020, focused on our now preferential approach using peripheral cannulation without a priori venting. During the study period, 255 patients underwent heart transplantation at our center and 26 (10.2%) of them required ECMO for PGD. Of 24 patients cannulated peripherally 19 (79%) were alive at 30 days and 17 (71%) 1 year after transplant; two additional patients underwent central ECMO cannulation due to unfavorable size of femoral vessels and concern for limb ischemia. Successful decannulation with full graft function recovery occurred in 22 of 24 (92%) patients cannulated peripherally. Six of them had an indwelling intra-aortic balloon pump placed before the transplantation. None of the other 18 patients received a ventricular vent. In conclusion, the use of an a priori peripheral and ventless ECMO approach in patients with PGD after heart transplant is an effective strategy associated with high rates of graft recovery and survival., Competing Interests: Disclosure: The authors have no conflicts of interest to report., (Copyright © ASAIO 2023.)

Tricuspid regurgitation (TR) is a progressive disease that can be addressed only partially by medical therapy. Progression of TR is associated with worsening end-organ function and worse survival, yet tricuspid valve interventions are usually only performed in advanced stages. Recent evidence suggests a pivotal role for TR and pulsatile venous congestion in the pathophysiology of renal and hepatic dysfunction. This critical knowledge has provided the opportunity to optimally define the appropriate timing of transcatheter tricuspid valve interventions, integrating concurrent or impending functional consequences with severity of TR., Competing Interests: Disclosure: The authors have no conflicts of interest to report., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

The 14th Annual Report from The Society of Thoracic Surgeons (STS) Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) describes outcomes of 27,493 patients with a continuous-flow left ventricular assist device (LVAD) from the past decade (2013-2022). In 2022, 2517 primary LVADs were implanted, of which 2512 (99.8%) were fully magnetically levitated (Mag-Lev) devices. This shift to nearly exclusive use of a Mag-Lev device led us to examine its outcomes compared with contemporary (2018-2022) and historical (2013-2017) non-Mag-Lev cohorts. Patients supported by a Mag-Lev device (n = 10,920) had a higher 1- and 5-year survival of 86% (vs 79% and 81%, P < .0001) and 64% (vs 44% and 44%, P < .0001), respectively, than those receiving non-Mag-Lev devices during the contemporary and historical eras. Over 5 years, freedom from gastrointestinal bleeding (72% vs 60%, P < .0001), stroke (87% vs 67%, P < .0001), and device malfunction/pump thrombus (83% vs 54%, P < .0001), but not device-related infection (61% vs 64%, P = .93), was higher with Mag-Lev devices compared with non-Mag-Lev support during the contemporary era. In this large primacy cohort of real-world patients with advanced heart failure, this report underscores marked improvements in short- and intermediate-term survival and reduction of adverse events with a contemporary Mag-Lev LVAD., (Copyright © 2024 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Importance: Left ventricular assist devices (LVADs) enhance quality and duration of life in advanced heart failure. The burden of nonsurgical bleeding events is a leading morbidity. Aspirin as an antiplatelet agent is mandated along with vitamin K antagonists (VKAs) with continuous-flow LVADs without conclusive evidence of efficacy and safety., Objective: To determine whether excluding aspirin as part of the antithrombotic regimen with a fully magnetically levitated LVAD is safe and decreases bleeding., Design, Setting, and Participants: This international, randomized, double-blind, placebo-controlled study of aspirin (100 mg/d) vs placebo with VKA therapy in patients with advanced heart failure with an LVAD was conducted across 51 centers with expertise in treating patients with advanced heart failure across 9 countries. The randomized population included 628 patients with advanced heart failure implanted with a fully magnetically levitated LVAD (314 in the placebo group and 314 in the aspirin group), of whom 296 patients in the placebo group and 293 in the aspirin group were in the primary analysis population, which informed the primary end point analysis. The study enrolled patients from July 2020 to September 2022; median follow-up was 14 months., Intervention: Patients were randomized in a 1:1 ratio to receive aspirin (100 mg/d) or placebo in addition to an antithrombotic regimen., Main Outcomes and Measures: The composite primary end point, assessed for noninferiority (-10% margin) of placebo, was survival free of a major nonsurgical (>14 days after implant) hemocompatibility-related adverse events (including stroke, pump thrombosis, major bleeding, or arterial peripheral thromboembolism) at 12 months. The principal secondary end point was nonsurgical bleeding events., Results: Of the 589 analyzed patients, 77% were men; one-third were Black and 61% were White. More patients were alive and free of hemocompatibility events at 12 months in the placebo group (74%) vs those taking aspirin (68%). Noninferiority of placebo was demonstrated (absolute between-group difference, 6.0% improvement in event-free survival with placebo [lower 1-sided 97.5% CI, -1.6%]; P < .001). Aspirin avoidance was associated with reduced nonsurgical bleeding events (relative risk, 0.66 [95% confidence limit, 0.51-0.85]; P = .002) with no increase in stroke or other thromboembolic events, a finding consistent among diverse subgroups of patient characteristics., Conclusions and Relevance: In patients with advanced heart failure treated with a fully magnetically levitated LVAD, avoidance of aspirin as part of an antithrombotic regimen, which includes VKA, is not inferior to a regimen containing aspirin, does not increase thromboembolism risk, and is associated with a reduction in bleeding events., Trial Registration: ClinicalTrials.gov Identifier: NCT04069156.

Background: The impact of donor transmitted atherosclerosis as assessed by intravascular ultrasound on development and progression of cardiac allograft vasculopathy (CAV) after heart transplantation (HT) remains poorly defined in contemporary practice. In this exploratory analysis, we sought to assess the prognostic role of early qualitative assessment of donor artery morphology using optical coherence tomography (OCT) as a more sensitive imaging modality., Methods: HT recipients were prospectively enrolled for baseline OCT imaging of the left anterior descending coronary artery. OCT findings were classified as normal, homogeneous intimal thickening, and advanced plaque characteristics. The endpoint was a composite of cardiac death, myocardial infarction, or new angiographically detectable CAV stratified by the International Society of Heart and Lung Transplantation criteria up to 4 years of follow-up., Results: A total of 35 patients underwent baseline OCT of whom 51.4% had normal OCT, 14.3% had homogenous plaque, and 34.3% had advanced characteristics. There were no significant differences in baseline demographics between patients with and without normal morphology. During a mean follow-up of 3.3 ± 0.4 years, the endpoint occurred in 11 patients including 1 death, 7 CAV 1 , 3 CAV 2 , and 1 CAV 3 . Kaplan-Meier analysis revealed a significantly higher event rate in patients with advanced characteristics (log-rank p = 0.010). In multivariate analysis, OCT-based plaque morphology was an independent predictor of clinical events (adjusted hazard ratio 4.57, 95% confidence interval 1.50-13.92, p = 0.008) while maximal intimal thickness ≥0.5 mm was not., Conclusions: Early qualitative OCT assessment of donor coronary artery morphology appears to be a reliable marker for predicting future cardiovascular events in HT recipients. Our findings warrant more careful study in a larger cohort., Competing Interests: Disclosure statement Y.K. and U.P.J. have served as a consultant to Abbott Vascular Inc. No other authors have a financial conflict of interest related to this research., (Copyright © 2023 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

The use of intra-aortic balloon pump (IABP) has decreased in recent years due to negative outcome studies in cardiogenic shock complicating acute myocardial infarction, despite its favorable adverse-event profile. Acute hemodynamic response studies have identified potential super-responders with immediate improvements in cardiac index (CI) in heart failure patients. This single-center retrospective study aimed to predict CI and mean arterial pressure (MAP) changes throughout the entire duration of IABP support. The study analyzed 336 patients who received IABP between 2016 and 2022. Linear mixed-effect regression models were used to predict CI and MAP improvement during IABP support. The results showed that CI and MAP increases during the first days of support, and changes during IABP support varied with time and were associated with baseline parameters. Longitudinal CI change was associated with body surface area, baseline CI, baseline pulmonary artery pulsatility index, baseline need for pressors, and diabetes. Longitudinal MAP change was associated with baseline MAP, baseline heart rate, need for pressors, or inotropes. The study recommends considering these parameters when deciding if IABP is the most appropriate form of support for a specific patient. Further prospective studies are needed to validate the findings., Competing Interests: Disclosure: F.C. is supported by a grant from the National Institute for Health (T32HL144456) and by the National Center for Advancing Translational Science (NCATS) Clinical and Translational Science Award at Einstein-Montefiore (UL1TR001073). U.P.J. is supported by the McAdam Family Foundation. The other authors have no conflicts of interest to report., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the ASAIO.)

Growing insights into the pathophysiology of acute cardiorenal syndrome (CRS) in acute decompensated heart failure have indicated that not every rise in creatinine is associated with adverse outcomes. Detection of persistent volume overload and diuretic resistance associated with creatinine rise may identify patients with true acute CRS. More in-depth phenotyping is needed to identify pathologic processes in renal arterial perfusion, venous outflow, and microcirculatory-interstitial-lymphatic axis alterations that can contribute to acute CRS. Recently, various novel device-based interventions designed to target different pathophysiologic components of acute CRS are in early feasibility and proof-of-concept studies. However, appropriate trial endpoints that reflect improvement in cardiorenal trajectories remain elusive and highly debated. In this review the authors describe the variety of physiological derangements leading to acute CRS and the opportunity to individualize the management of acute CRS with novel renal assist devices that can target specific components of these alterations., Competing Interests: Funding Support and Author Disclosures Dr Martens is supported by a grant from the Belgian American Educational Foundation and the Frans Van de Werf Fund. Dr Burkhoff has served as a consultant to AquaPass. Dr Cowger has served as a consultant for Procyrion, Nuwellis (unpaid), and Abbott; and has received stock options from Procyrion. Dr Jorde has served as a consultant for Abbott and Edwards Lifesciences; and holds equity interest in Revamp. Dr Kapur has served as a consultant and speaker for and has institutional research agreements with Abbott, Abiomed, Boston Scientific, Getinge, LivaNova, Edwards Lifesciences, Telelfex, and Zoll. Dr Tang has served as a consultant for Sequana Medical, Cardiol Therapeutics, Genomics, Zehna Therapeutics, Renovacor, Boston Scientific, WhiteSwell, Kiniksa Pharmaceuticals, and CardiaTec Biosciences; and has received honoraria from Springer Nature and the American Board of Internal Medicine., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Non-ST-segment myocardial infarction (NSTEMI) occurs frequently in a growing population of patients with chronic heart failure (HF) and end-stage renal disease (ESRD) but outcomes with invasive management approaches are unknown. We sought to determine in-hospital outcomes with percutaneous coronary intervention (PCI) in comparison with medical management only. The National Inpatient Sample was used to capture hospitalizations in the United States from 2006 to 2019. Admissions for NSTEMI in patients with chronic HF and ESRD were identified by International Classification of Diseases codes. The cohort was divided into those that received PCI or medical management only. In-hospital outcomes were compared by multivariable logistic regression and propensity matching. In 27,433 hospitalizations, 8,004 patients (29%) underwent PCI, and 19,429 (71%) were managed with medications only. PCI was associated with lower adjusted odds of death during hospitalization (adjusted odds ratio 0.59, 95% confidence interval 0.52 to 0.66, p <0.01). This association remained consistent after propensity matching (adjusted odds ratio 0.56, 95% confidence interval 0.49 to 0.64, p <0.01) and was apparent across all subtypes of HF. Patients with PCI had greater duration (5, 3, to 9 vs, 5, 3 to 8 days, p <0.01) and cost of hospitalization ($107,942, 70,230 to $173,182 vs, $44,156, 24,409 to $80,810, p <0.01). In conclusion, patients with HF and ESRD admitted for NSTEMI experienced lower in-hospital mortality with PCI in comparison with medical therapy only. Invasive percutaneous revascularization may be reasonable for appropriately selected patients with HF and ESRD but randomized controlled trials are needed to determine its safety and efficacy in this high-risk population., Competing Interests: Declaration of Competing Interest The authors have no conflicts of interest to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Left ventricular (LV) volume reshaping reduces myocardial wall stress and may induce reverse remodeling in patients with heart failure with reduced ejection fraction. The AccuCinch Transcatheter Left Ventricular Restoration system consists of a series of anchors connected by a cable implanted along the LV base that is cinched to the basal free wall radius. We evaluated the echocardiographic and clinical outcomes following transcatheter left ventricular restoration., Methods and Results: We analyzed 51 heart failure patients with a left ventricular ejection fraction between 20% and 40%, with no more than 2+ mitral regurgitation treated with optimal medical therapy, who subsequently underwent transcatheter left ventricular restoration. Serial echocardiograms, Kansas City Cardiomyopathy Questionnaire scores, and 6-minute walk test distances were measured at baseline through 12 months. Primary analysis end point was change in end-diastolic volume at 12 months compared with baseline. Patients (n = 51) were predominantly male (86%) with a mean age of 56.3 ± 13.1 years. Fluoroscopy showed LV free wall radius decreased by a median of 9.2 mm amounting to a 29.6% decrease in the free wall arc length. At 12 months, the LV end-diastolic volume decreased by 33.6 ± 34.8 mL (P < .01), with comparable decreases in the LV end-systolic volume. These decreases were associated with significant improvements in the overall Kansas City Cardiomyopathy Questionnaire score (16.4 ± 18.7 points; P < .01) and 6-minute hall walk test distance (45.9 ± 83.9 m; P < .01). There were no periprocedural deaths; through the 1-year follow-up, 1 patient died (day 280) and 1 patient received a left ventricular assist device (day 13)., Conclusions: In patients with heart failure with reduced ejection fraction without significant mitral regurgitation receiving optimal medical therapy, the AccuCinch System resulted in decreases of LV volume, as well as improved quality of life and exercise endurance. A randomized trial is ongoing (NCT04331769)., Competing Interests: Conflicts of Interest Nadira Hamid reports Institutional grant support. Ulrich Jorde reports travel support from Ancora Heart. Mark Reisman reports travel support from Ancora Heart. Azeem Latib has nothing to declare. D. Scott Lim has nothing to declare. Susan Joseph has nothing to declare. Alena Kurlianskaya has nothing to declare. Oleg Polonetsky, MD, reports consultancy fees from Ancora Heart, and consultancy or proctoring fees from Edwards Lifesciences and Medtronic. Petr Neuzil has nothing to declare. Vivek Reddy has nothing to declare. Jason Foerst has nothing to declare. Hemal Gada has nothing to declare. Kendra J. Grubb reports advisory board and consulting fees for Medtronic, Boston Scientific, Abbott, Ancora, 4C Medical, and honorarium for Edwards Lifesciences. Guilherme Silva has nothing to declare. Dean Kereiakes has nothing to declare. Satya Shreenivas has nothing to declare. Sean Pinney reports consulting fees from Abbott, CareDx, Medtronic, Procyrion, and Transmedics. Giedrius Davidavicius is a consultant to Ancora Heart. Paul Sorajja has nothing to declare. John Boehmer has nothing to declare. Franz X. Kleber is a consultant to Ancora Heart. Patrick Perier has nothing to declare. Nicolas M. Van Mieghem reports research grant support from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, PulseCath BV, Abiomed, Siemens, and Daiichi Sankyo. Nicolas Dumonteil reports consultancy fees from Ancora Heart, is the co-PI of the CorCinch European study; and reports consultancy and proctoring fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic. Martin B. Leon reports institutional clinical research grants from Abbott, Abiomed, Ancora, Boston Scientific, Edwards, and Medtronic. Daniel Burkhoff reports institutional grant support from Ancora Heart to the Cardiovascular Research Foundation., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: There is a paucity of data on heart transplantation (HT) using COVID-19 donors., Objectives: This study investigated COVID-19 donor use, donor and recipient characteristics, and early post-HT outcomes., Methods: Between May 2020 and June 2022, study investigators identified 27,862 donors in the United Network for Organ Sharing, with 60,699 COVID-19 nucleic acid amplification testing (NAT) performed before procurement and with available organ disposition. Donors were considered "COVID-19 donors" if they were NAT positive at any time during terminal hospitalization. These donors were subclassified as "active COVID-19" (aCOV) donors if they were NAT positive within 2 days of organ procurement, or "recently resolved COVID-19" (rrCOV) donors if they were NAT positive initially but became NAT negative before procurement. Donors with NAT-positive status >2 days before procurement were considered aCOV unless there was evidence of a subsequent NAT-negative result ≥48 hours after the last NAT-positive result. HT outcomes were compared., Results: During the study period, 1,445 "COVID-19 donors" (COVID-19 NAT positive) were identified; 1,017 of these were aCOV, and 428 were rrCOV. Overall, 309 HTs used COVID-19 donors, and 239 adult HTs from COVID-19 donors (150 aCOV, 89 rrCOV) met study criteria. Compared with non-COV, COVID-19 donors used for adult HT were younger and mostly male (∼80%). Compared with HTs from non-COV donors, recipients of HTs from aCOV donors had increased mortality at 6 months (Cox HR: 1.74; 95% CI: 1.02-2.96; P = 0.043) and 1 year (Cox HR: 1.98; 95% CI: 1.22-3.22; P = 0.006). Recipients of HTs from rrCOV and non-COV donors had similar 6-month and 1-year mortality. Results were similar in propensity-matched cohorts., Conclusions: In this early analysis, although HTs from aCOV donors had increased mortality at 6 months and 1 year, HTs from rrCOV donors had survival similar to that seen in recipients of HTs from non-COV donors. Continued evaluation and a more nuanced approach to this donor pool are needed., Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Resting myocardial blood flow (MBF) and myocardial flow reserve (MFR) are reduced in heart failure (HF) patients supported by pulsatile left ventricular assist devices (LVADs). The effect of continuous-flow (CF) physiology on these parameters is underexplored in CF-LVAD patients. We investigated the impact of CF-LVADs on resting MBF and MFR under two left ventricular (LV) loading conditions. Nine HeartMate II patients (42 ± 12 years, 100% male) on support for 370 ± 281 days were enrolled. Results were compared with 9 HF patients (58 ± 13 years, 67% male, LV ejection fraction 27 ± 9%) and 10 healthy volunteers (56 ± 10 years, 20% male). CF-LVAD patients underwent transthoracic echocardiography with ramp study. MBF and MFR were measured utilizing positron emission/computed tomography imaging under two LV loading conditions: "high-speed" (HS), promoting aortic valve (AV) closure and LV unloading; "low-speed" (LS), promoting AV opening and LV loading. Global resting MBF was similar in HS, LS, HF, and healthy: 0.8 ± 0.3, 0.7 ± 0.3, 0.7 ± 0.1, 0.9 ± 0.2 ml/min/g, respectively; p = NS. HS global MFR was reduced compared with LS and HF: 1.6 ± 0.6 versus 1.9 ± 0.5, p = 0.004; 1.6 ± 0.6 versus 2.4 ± 0.5, p = 0.01, respectively. HS regional MFR was reduced compared with LS in the left anterior descending (1.7 ± 0.7 vs. 2.0 ± 0.6, p = 0.027) and left circumflex (1.8 ± 0.7 vs. 2.2 ± 0.9, p = 0.008), but not in right coronary artery (1.7 ± 0.7 vs. 1.7 ± 0.6, p = 0.76). Resting MBF is preserved among CF-LVAD patients and is similar to HF and healthy. Promoting LV ventricular unloading with higher speed was associated with lower global and regional left coronary MFR, while right coronary MFR did not change., Competing Interests: P.C.C. is consultant for Abbott; Ulrich P. Jorde is consultant for Abbott. The remaining authors have no conflicts of interest to report., (Copyright © ASAIO 2022.)

The use of venoarterial extracorporeal membrane oxygenation (VA-ECMO) in adults for refractory cardiogenic shock has risen exponentially during the prior decade. Although VA-ECMO provides cardiopulmonary support, it can alter left ventricular (LV) loading conditions leading to LV distension, which makes the lungs susceptible to congestion and promotes intracardiac thrombosis. These conditions can be alleviated by pharmacologic and mechanical unloading, but gaps in knowledge remain on optimal timing and methods of this approach. This review provides an overview of the epidemiology of VA-ECMO, describes pathophysiology and methods for monitoring and reducing LV loading and summarizes contemporary studies examining the association between LV unloading and adverse events. We offer a simple protocol for implementing LV unloading during VA-ECMO to provide pulmonary protection and improve outcomes., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Recent clinical trials have highlighted the profound benefits of sodium-glucose linked transporter 2 inhibitors (SGLT2i) on cardiovascular mortality and hospitalization for heart failure patients. Modest improvements in glycemic, lipid, or blood pressure control are unlikely to contribute to these significant beneficial outcomes, generating much interest in the relevant mechanisms leading to outcome improvements. In this review, we discuss the current evidence supporting a shift in myocardial substrate utilization from carbohydrates and fat oxidation toward energy efficient ketone bodies in the failing heart and the role of SGLT2i in this key metabolic adaptation to optimize myocardial fuel energetics. Further insights into the effect of SGLT2i on the indices of cardiorespiratory fitness are outlined and provide important clues into their mechanism of benefit. This mechanistic discussion in the context of recent trials of SGLT2i denotes a promising treatment paradigm of heart failure in individuals with and without diabetes., Competing Interests: Disclosure: The authors declare no funding and conflict of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Despite significant advances in the medical management of patients living with heart failure, there continues to be significant morbidity and mortality associated with the condition. There is a growing need for research and development of additional modalities to fill the management and treatment gaps, reduce hospitalisations and improve the quality of life for patients living with heart failure. In the last decade, there has been a rapid rise in the use of non-valvular catheter-based therapies for the management of chronic heart failure to complement existing guideline-directed management. They target well-defined mechanistic and pathophysiological processes critical to the progression of heart failure including left ventricular remodelling, neurohumoral activation, and congestion. In this review, we will explore the physiology, rationale, and current stages of the clinical development of the existing procedures.

The Jarvik 2000 bridge to transplant investigational device exemption study was a multicentered, prospective study of 150 UNOS status I patients implanted with the Jarvik 2000 between 2005 and 2012. During the study period, there were numerous modifications of the system that included converting from pin to cone bearings. Results were analyzed for three cohorts: total (n = 150), pin (n = 128), and cone (n = 22). Baseline demographics included age (52 ± 13), gender (79% male), size (BSA 1.98), and etiology (37% idiopathic dilated cardiomyopathy; 43% Ischemic). Seventy percent of patients were either INTERMACS 1 or 2. The primary endpoint-defined as successful transplantation or listing at 180 days (prespecified at 65%; 95% lower CI: 57%)-was successfully achieved for the total cohort (67.3%; 95% CI: 59.5%-74.3%; p = 0.006). In subgroup analysis of the more contemporary, cone-bearing group, the primary endpoint was met in 91% (95% CI: 72%-97.5%; p = 0.001). Compared with pin patients, cone-bearing patients had less hemolysis as well as decreased end-organ dysfunction. Functional and quality of life scores improved after implantation independent type of bearing. In conclusion, despite a particularly sick patient population, the Jarvik 2000 was shown to be effective in supporting the advanced HF patient., (Copyright © ASAIO 2022.)

The 13th annual report from The Society of Thoracic Surgeons (STS) Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) highlights outcomes for 27,314 patients receiving continuous-flow durable left ventricular assist devices (LVAD) during the last decade (2012-2021). In 2021, 2464 primary LVADs were implanted, representing a 23.5% reduction in the annual volume compared with peak implantation in 2019 and an ongoing trend from the prior year. This decline is likely a reflection of the untoward effects of the coronavirus disease 2019 pandemic and the change in the United States heart transplant allocation system in 2018. The last several years have been characterized by a shift in device indication and type, with 81.1% of patients now implanted as destination therapy and 92.7% receiving an LVAD with full magnetic levitation in 2021. However, despite an older, more ill population being increasingly supported preimplant with temporary circulatory devices in the recent (2017-2021) vs prior (2012-2016) eras, the 1- and 5-year survival continues to improve, at 83.0% and 51.9%, respectively. The adverse events profile has also improved, with a significant reduction in stroke, gastrointestinal bleeding, and hospital readmissions. Finally, we examined the impact of the change in the heart transplant allocation system in 2018 on LVAD candidacy, implant strategy, and outcomes. In the competing-outcomes analysis, the proportion of transplant-eligible patients receiving a transplant has declined from 56.5% to 46.0% at 3 years, whereas the proportion remaining alive with ongoing support has improved from 24.1% to 38.1% at 3 years, underscoring the durability of the currently available technology., (Copyright © 2023 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Stroke is one of the leading complications following durable mechanical circulatory support (MCS) implantation. The aim of this multicenter study was to investigate stroke complications in patients requiring durable MCS following extracorporeal life support (ECLS). Data of 11 high volume MCS centers were collected and evaluated to identify patients who underwent durable MCS implantation after ECLS support between January 2010 and August 2018. The primary outcome was stroke following durable MCS implantation. Univariate and multivariate logistic regression analyses were performed to determine predictors of stroke. Overall, 531 patients met the inclusion criteria. Only patients who were supported with continuous flow pumps were included in this study accounting for 495 patients (median age 54 years old [interquartile range 47-60]). A total of 136 patients (27%) developed postoperative stroke on device during the follow-up (48% ischemic and 52% hemorrhagic) after a median durable MCS support of 320 [32-1,000] days, accounting for 0.17 events per patient-year. Of 133 patients with known date of stroke, a total of 47 (10%) developed stroke during the first 30 days (64% ischemic and 36% hemorrhagic), and 86 patients developed stroke after 30 days (38% ischemic and 62% hemorrhagic) of durable MCS support (late stroke). Survival rate was significantly lower in patients with hemorrhagic stroke ( p = 0.00091). Stroke appears to be a common complication in patients transitioned to durable MCS support after ECLS. Hemorrhagic stroke is a more common type of late stroke and is associated with inferior outcomes., Competing Interests: Disclosure: The authors declare no funding and conflicts of interest to report., (Copyright © ASAIO 2022.)

In heart failure (HF) patients, the pathophysiological mechanisms of severe exercise intolerance and impaired exercise capacity are related to both central and peripheral abnormalities. The central abnormalities in HF patients include impaired cardiac function and chronotropic incompetence (CI). Indeed, CI, the inability to adequately increase heart rate (HR) from rest to exercise often exhibited by HF patients, is related to activation of the sympathetic nervous system (SNS) yielding a rise in circulating norepinephrine (NE). CI may result from downregulation of β-adrenergic receptors, β-blocker usage, high baseline HR, or due to a combination of factors. This paper discusses the role of elevated NE in altering chronotropic responses in HF patients and consequently resulting in impaired exercise capacity. We suggest that future research should focus on the potential treatment of CI with rate-adaptive pacing, using a sensor to measure physical activity, without inducing deleterious hormonal activation of the sympathetic system., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Anticoagulation during extracorporeal membrane oxygenation (ECMO) for Coronovirus Disease 2019 (COVID-19) can be performed by direct or indirect thrombin inhibitors but differences in outcomes with these agents are uncertain. A retrospective, multicenter study was conducted. All consecutive adult patients with COVID-19 placed on ECMO between March 1, 2020 and April 30, 2021 in participating centers, were included. Patients were divided in groups receiving either a direct thrombin inhibitor (DTI) or an indirect thrombin inhibitor such as unfractionated heparin (UFH). Overall, 455 patients with COVID-19 from 17 centers were placed on ECMO during the study period. Forty-four patients did not receive anticoagulation. Of the remaining 411 patients, DTI was used in 160 (39%) whereas 251 (61%) received UFH. At 90-days, in-hospital mortality was 50% (DTI) and 61% (UFH), adjusted hazard ratio: 0.81, 95% confidence interval (CI): 0.49-1.32. Deep vein thrombosis [adjusted odds ratio (aOR): 2.60, 95% CI: 0.90-6.65], ischemic (aOR: 1.58, 95% CI: 0.18-14.0), and hemorrhagic (aOR:1.22, 95% CI: 0.39-3.87) stroke were similar with DTI in comparison to UFH. Bleeding requiring transfusion was lower in patients receiving DTI (aOR: 0.40, 95% CI: 0.18-0.87). Anticoagulants that directly inhibit thrombin are associated with similar in-hospital mortality, stroke, and venous thrombosis and do not confer a higher risk of clinical bleeding in comparison to conventional heparin during ECMO for COVID-19., Competing Interests: Disclosure: The authors have no conflicts of interest to report., (Copyright © ASAIO 2022.)

Background: Transcatheter tricuspid valve replacement (TTVR) is rapidly emerging as a therapeutic option amongst patients with secondary tricuspid regurgitation. Historical data from surgical tricuspid valve replacement (TVR) studies may serve as a benchmark for the development of TTVR trials., Aims: The aim of the study was to investigate the early and late outcomes following isolated surgical TVR., Methods: Multiple electronic databases were searched to identify studies on isolated surgical TVR. The prespecified primary endpoint was operative mortality; secondary endpoints were early and late outcomes. Overall estimates of proportions and incidence rates with 95% confidence intervals (CI) were calculated using random-effects models. Multiple sensitivity analyses accounting for baseline characteristics, country and the operative period were applied.  Results: A total of 35 studies (5,316 patients) were included in this meta-analysis. The operative period ranged from 1974 to 2019. The overall rate of operative mortality was 12% (95% CI: 9-15), with higher mortality for patients who were operated on before 1995, who had prior cardiac surgeries, or who had liver disease. The most frequent clinical events were pacemaker implantation (10% [95% CI: 6-16]), bleeding (12% [95% CI: 8-17]), acute kidney injury (15% [95% CI: 9-24]) and respiratory complications (15% [95% CI: 12-20]). At follow-up analysis of the bioprosthetic TVR, there was an incidence rate per 100 person-years of 6 (95% CI: 2-13) for death and 8 (95% CI: 5-13) for recurrence of significant tricuspid regurgitation., Conclusions: This meta-analysis provides an overview of the historical clinical outcomes following isolated surgical TVR. These findings can support the development of future clinical trials in the tricuspid space by providing thresholds for clinical outcomes.