Search

Background: An interatrial shunt may provide an autoregulatory mechanism to decrease left atrial pressure and improve heart failure (HF) symptoms and prognosis., Methods: Patients with symptomatic HF with any left ventricular ejection fraction (LVEF) were randomized 1:1 to transcatheter shunt implantation versus a placebo procedure, stratified by reduced (≤40%) versus preserved (>40%) LVEF. The primary safety outcome was a composite of device-related or procedure-related major adverse cardiovascular or neurological events at 30 days compared with a prespecified performance goal of 11%. The primary effectiveness outcome was the hierarchical composite ranking of all-cause death, cardiac transplantation or left ventricular assist device implantation, HF hospitalization, outpatient worsening HF events, and change in quality of life from baseline measured by the Kansas City Cardiomyopathy Questionnaire overall summary score through maximum 2-year follow-up, assessed when the last enrolled patient reached 1-year follow-up, expressed as the win ratio. Prespecified hypothesis-generating analyses were performed in patients with reduced and preserved LVEF., Results: Between October 24, 2018, and October 19, 2022, 508 patients were randomized at 94 sites in 11 countries to interatrial shunt treatment (n=250) or a placebo procedure (n=258). Median (25th and 75th percentiles) age was 73.0 years (66.0, 79.0), and 189 patients (37.2%) were women. Median LVEF was reduced (≤40%) in 206 patients (40.6%) and preserved (>40%) in 302 patients (59.4%). No primary safety events occurred after shunt implantation (upper 97.5% confidence limit, 1.5%; P <0.0001). There was no difference in the 2-year primary effectiveness outcome between the shunt and placebo procedure groups (win ratio, 0.86 [95% CI, 0.61-1.22]; P =0.20). However, patients with reduced LVEF had fewer adverse cardiovascular events with shunt treatment versus placebo (annualized rate 49.0% versus 88.6%; relative risk, 0.55 [95% CI, 0.42-0.73]; P <0.0001), whereas patients with preserved LVEF had more cardiovascular events with shunt treatment (annualized rate 60.2% versus 35.9%; relative risk, 1.68 [95% CI, 1.29-2.19]; P =0.0001; P interaction <0.0001). There were no between-group differences in change in Kansas City Cardiomyopathy Questionnaire overall summary score during follow-up in all patients or in those with reduced or preserved LVEF., Conclusions: Transcatheter interatrial shunt implantation was safe but did not improve outcomes in patients with HF. However, the results from a prespecified exploratory analysis in stratified randomized groups suggest that shunt implantation is beneficial in patients with reduced LVEF and harmful in patients with preserved LVEF., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03499236., Competing Interests: Dr Stone has received speaker honoraria from Medtronic, Pulnovo, Abiomed, Amgen, and Boehringer Ingelheim; has served as a consultant to Abbott, Daiichi Sankyo, Ablative Solutions, CorFlow, CardioMech, Robocath, Miracor, Vectorious, Apollo Therapeutics, Elucid Bio, Cardiac Success, Valfix, TherOx, HeartFlow, Neovasc, Ancora, Occlutech, Impulse Dynamics, Adona Medical, Millennia Biopharma, Oxitope, HighLife, Elixir, Remote Cardiac Enablement, and Aria; and has equity or options from Cardiac Success, Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Valfix, and Xenter. Dr Stone’s employer, Mount Sinai Hospital, receives research grants from Shockwave, Abbott, Abiomed, BioVentrix, Cardiovascular Systems Inc, Phillips, Biosense-Webster, Vascular Dynamics, Pulnovo, V-wave, and PCORI (via Weill Cornell Medical Center). Dr Lindenfeld has received consulting fees from Abbott, Alleviant, Axon, AstraZeneca, Boston Scientific, CVRx, Merck, Medtronic, Edwards Lifesciences, V-Wave Medical, WhiteSwell, Vascular Dynamics, and Bayer. Dr Rodés-Cabau has received grants from V-Wave, Edwards Lifesciences, Medtronic, and Boston Scientific; received consulting fees from V-Wave Medical, Edwards Lifesciences, and Medtronic; and has received payment for presentations from Edwards Lifesciences and Medtronic. Dr Rodés-Cabau’s employer receives funding for enrollment in clinical trials for V-Wave Medical. Dr Anker serves as a consultant to Abbott Vascular, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Brahms GmbH, Cardiac Dimensions, Cardior, Cordia, CVRx, Inc, Cytokinetics, Edwards Lifesciences, Faraday Pharmaceuticals, GlaxoSmithKline, HeartKinetics, Impulse Dynamics (USA) Inc, Novartis, Occlutech, Pfizer, Regeneron, Repairon, Sensible Medical Innovations Ltd, Servier, V-Wave Medical, Vectorius, and Vifor; and has 2 patent applications regarding MR-proANP (midregional pro-atrial natriuretic peptide) through Brahms GmbH. Dr Anker’s employer Charité University Medicine Berlin has received grants from Vifor (International) Ltd. Dr Zile has consulting contracts for advisory committees with Abbott, Adona Medical, Aria CV, Avery Therapeutics, Inc, Boehringer-Ingelheim, Boston Scientific, Cardiovascular Research Foundation (CRF) Clinical Trials Center, CVRx, Diasol Therapeutics, LLC, EBR, Edwards, Eli Lilly, Endotronix, Medtronic, Merck, Morphic Therapeutics, Novartis, Salubris Biotherapeutics, Sonata, Srnalytics, Inc, V-Wave Medical, and Vectorious. Dr Kar has received grants and contracts from Abbott, Boston Scientific, Medtronic, Edwards Lifesciences, Laminar, and Picardia; has received consulting fees from Abbott, Medtronic, Boston Scientific, and V-Wave Medical; is a member of the executive committee for V-Wave Medical and advisory boards for Abbott, Boston Scientific, Medtronic, and InterShunt; has stock or stock options in PiCardia and Laminar; serves as the co–principal investigator for REAPIR-MR, CHAMPION, and Laminar Pivotal Trial. Dr Holcomb has received support for preparation of this article and has received consulting fees from V-Wave Medical and has received support for meeting attendance. Dr Pfeiffer has received honoraria from Abbott Cardiovascular and AncoraHeart. Dr Pfeiffer’s employer, The Penn State University and The Milton S. Hershey Medical Center, receives funding from V-Wave Medical for serving as the echo core laboratory. Dr Bayes-Genis has received honoraria for presentations from Abbott, AstraZeneca, Bayer, Boehringer Ingelheim, Medtronic, Novartis, Novo Nordisk, Roche Diagnostics, and Vifor. Dr Bax has served on the advisory board for V-Wave and receives reimbursement for serving on the eligibility committee for V-Wave and receives speaker fees from Abbott Vascular and Edwards Lifesciences. Dr Bax’s employer, Leiden University Medical Center, receives research grants from Abbot Vascular, Alnylam, Bayer, Bioventrix, Biotronik, Boston Scientific, Edwards Lifesciences, GE Healthcare, Medtronic, Medis, Novartis, Pfizer, and Pie Medical. Dr Bank has received consulting fees for serving on the advisory board and eligibility committee for V-Wave. Dr Costanzo has received grants or contracts from V-Wave, Bayer, and Alleviant as a site PI; has received consulting fees from Boehringer-Ingelheim, Nuwellis, V-Wave, and Alleviant; participated on DSMB/advisory boards for Merck and Boehringer-Ingelheim; and serves on the board of directors of Nuwellis. Dr Verheye has received consulting fees from Shockwave and Elixir Medical and stock or options for V-Wave and serves on the advisory board and eligibility committee for V-Wave. Dr Roguin serves on the advisory board for V-Wave and receives money for serving on the eligibility committee for V-Wave. Dr Filippatos has received grants from the European Commission; has received honoraria from Bayer, Boehringer Ingelheim, Servier, and Novartis; serves in a fiduciary role for the Heart Failure Association and JACC Heart Failure; serves on trial committees for Medtronic, Bayer, Boehringer Ingelheim, Vifor, Amgen, Servier, Impulse Dynamics, Cardior, and Novo Nordisk; and has received consulting fees from Cardio and Novo Nordisk. Dr Núñez has received consulting fees from Novartis, Boehringer Ingelheim, Bayer, and Novo Nordisk; and receives fees for lecture presentations from Alleviant, AstraZeneca, Boehringer Ingelheim, Bayer, Novartis, Novo Nordisk, Pfizer, Rovi, and Vifor Pharma. Dr Laufer-Perl has received consulting fees from Alleviant Medical and Unipharm; receives payment or honoraria from AbbVie Biopharmaceuticals, Alleviant Medical, AstraZeneca, Boehringer Ingelheim, Novartis, Medison, Novo Nordisk, Bayer, Unipharm, and CTS; received support for attending meetings from Alleviant Medical; is a participant on DSMB or advisory boards for Boehringer Ingelheim, AstraZeneca, and Bayer; and has received institutional grants from Boehringer Ingelheim, AstraZeneca, Pfizer, Novartis, Bayer, and the Israel Cancer Association. Dr Litwin has received grants for patient selection committees for a clinical trial for a different atrial shunt study for Corvia and served in a fiduciary role as associate editor for the Journal of the American Society for Echocardiography. Dr Litwin’s employer, MUSC, receives funding for enrollment in trials for V-Wave Medical and Corvia. Dr Prihadi has received consulting fees from Novartis, Boehringer Ingelheim, Bayer, Abbott, and Astra Zeneca; has received honoraria for presentations from Novartis, Boehringer Ingelheim, AstraZeneca, Menarinin, Vifor, and Novo Nordisk; has received support for attendance at meetings from Pfizer and Bayer; and has participated on advisory boards for AstraZeneca and Novartis. Dr Chung has received consulting fees from Intershunt, Corvia, Medtronic, and Abbott. Dr Price has received consulting fees from Abbott, Boston Scientific, Medtronic, Shockwave, Philips Medical, Alleviant Medical, and Innovheart; has received honoraria for presentations from WL Gore, Abbott, Shockwave, and Philips Medical; has served on DSMB or advisory boards for Axio Research (Portico NG and Vantage Trials); has served on the American College of Cardiology NCDR LAAO Research and Publication Committee; and holds stock or stock options from InterShunt, Indian Welss, Bolt Medical, Atraverse, and Advanced Bifurcation systems. Dr Thohan has received honoraria from Pfizer and Boehringer Ingelheim. Dr Schewel has received consulting fees from V-Wave Medical for proctoring intervention procedures. Dr Eigler has patents issued and planned for V-Wave Ltd and V-Wave Inc; is a shareholder and stock option holder as an employee of V-Wave Medical; is the chief executive officer of V-Wave Medical; and receives compensation in the form of salary, bonus, and stock option grants. Dr Abraham has received honoraria from Impulse Dynamics, Edwards Lifesciences, and Abbott; has received consulting fees from Zoll Respicardia; has stock in V-Wave Ltd; has a patent for mobile ultrawideband radar for monitoring thoracic fluid levels and cardiorespiratory function (publication No. 20210290074); has participated on advisory boards or data safety and monitoring boards for Sensible Medical, WhiteSwell, AquaPass, Cordio Medical, and Boehringer-Ingelheim; and his institution has received a grant from the National Institutes of Health (1 UG3/UH3 HL140144-01; LOFT-HF [Impact of Low Flow Nocturnal Oxygen Therapy on Hospital Readmission/Mortality in Patients with Heart Failure and Central Sleep Apnea]). The other authors report no disclosures.

Objective: Severe secondary tricuspid regurgitation (STR) causes significant right atrial (RA) volume overload, resulting in structural and functional RA-remodelling. This study evaluated whether patients with severe STR and reduced RA function, as assessed by RA-reservoir-strain (RASr), show lower long-term prognosis., Methods: Consecutive patients, from a single centre, with first diagnosis of severe STR and RASr measure available, were included. Extensive echocardiographic analysis comprised measures of cardiac chamber size and function, assessed also by two-dimensional speckle-tracking strain analysis. Primary outcome was all-cause mortality, analysed from inclusion until death or last follow-up. The association of RASr with the outcome was evaluated by Cox regression analysis and Akaike information criterion., Results: A total of 586 patients with severe STR (age 68±13 years; 52% male) were included. Patients presented with mild right ventricular (RV) dilatation (end-diastolic area 13.8±6.5 cm 2 /m 2 ) and dysfunction (free-wall strain 16.2±7.2%), and with moderate-to-severe RA dilatation (max area 15.0±5.3 cm 2 /m 2 ); the median value of RASr was 13%. In the overall population, 10-year overall survival was low (40%, 349 deaths), and was significantly lower in patients with lower RASr (defined by the median value): 36% (195 deaths) for RASr ≤13% compared with 45% (154 deaths) for RASr >13% (log-rank p=0.016). With a median follow-up of 6.6 years, RASr was independently associated with all-cause mortality (HR per 5% RASr increase:0.928; 95% CI 0.864 to 0.996; p=0.038), providing additional value over relevant clinical and echocardiographic covariates (including RA size and RV function/size)., Conclusions: Patients with severe STR presented with significant RA remodelling, and lower RA function, as measured by RASr, was independently associated with all-cause mortality, potentially improving risk stratification in these patients., Competing Interests: Competing interests: The Department of Cardiology, Heart Lung Centre, Leiden University Medical Centre has received unrestricted research grants from Abbott Vascular, Alnylam, Bayer, Biotronik, Bioventrix, Boston Scientific, Edwards Lifesciences, GE Healthcare, Medtronic, Medis, Pie Medical, Pfizer, and Novartis. VD received speaker fees from Abbott Vascular, Edwards Lifesciences, GE Healthcare, Medtronic, MSD and Novartis. JJB received speaker fees from Abbott Vascular, Edwards Lifesciences and Omron. NAM received speaker fees from Abbott Vascular, Philips Ultrasound and GE Healthcare. The remaining authors have nothing to disclose., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Aims: To describe the baseline characteristics of participants in the Acetazolamide in Decompensated Heart Failure with Volume Overload (ADVOR) trial and compare these with other contemporary diuretic trials in acute heart failure (AHF)., Methods and Results: ADVOR recruited 519 patients with AHF, clinically evident volume overload, elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) and maintenance loop diuretic therapy prior to admission. All participants received standardized loop diuretics and were randomized towards once daily intravenous acetazolamide (500 mg) versus placebo, stratified according to study centre and left ventricular ejection fraction (LVEF) (≤40% vs. &gt;40%). The primary endpoint was successful decongestion assessed by a dedicated score indicating no more than trace oedema and no other signs of congestion after three consecutive days of treatment without need for escalating treatment. Mean age was 78 years, 63% were men, mean LVEF was 43%, and median NT-proBNP 6173 pg/ml. The median clinical congestion score was 4 with an EuroQol-5 dimensions health utility index of 0.6. Patients with LVEF ≤40% were more often male, had more ischaemic heart disease, higher levels of NT-proBNP and less atrial fibrillation. Compared with diuretic trials in AHF, patients enrolled in ADVOR were considerably older with higher NT-proBNP levels, reflecting the real-world clinical situation., Conclusion: ADVOR is the largest randomized diuretic trial in AHF, investigating acetazolamide to improve decongestion on top of standardized loop diuretics. The elderly enrolled population with poor quality of life provides a good representation of the real-world AHF population. The pragmatic design will provide novel insights in the diuretic treatment of patients with AHF., (© 2022 European Society of Cardiology.)

Objectives: This study evaluated the prognostic value of staging right heart failure in patients with significant tricuspid regurgitation (TR) undergoing tricuspid valve (TV) surgery., Methods: Patients with significant TR who underwent TV surgery were divided into 4 right heart failure stages according to the presence of right ventricular (RV) dysfunction and clinical signs of right heart failure: stage 1 was defined as no RV dysfunction and no signs of right heart failure; stage 2 indicated RV dysfunction without signs of right heart failure; stage 3 included RV dysfunction and signs of right heart failure; and stage 4 was defined as RV dysfunction and refractory signs of right heart failure at rest., Results: A total of 278 patients [mean age 64 (12), 49% males] were included, of whom 34 (12%) patients were classified as stages 1 and 2, 141 (51%) as stage 3 and 103 (37%) as stage 4 right heart failure. The majority of patients (91%) had TV surgery concomitant to left-sided valve surgery or coronary artery bypass grafting and 95% underwent TV annuloplasty. Cumulative survival rates were 89%, 78% and 61% at 1 month, 1 year and 5 years, respectively. Stages 1 and 2 and stage 3 were independently associated with better survival compared to stage 4 (hazard ratio: 0.391 [95% confidence interval: 0.186-0.823] and 0.548 [95% confidence interval: 0.369-0.813], respectively)., Conclusions: Patients with significant TR undergoing TV surgery and diagnosed without advanced right heart failure have better survival as compared to patients with right heart failure., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Aims: We assessed the outcome of hospitalized coronavirus disease 2019 (COVID-19) patients with heart failure (HF) compared with patients with other cardiovascular disease and/or risk factors (arterial hypertension, diabetes, or dyslipidaemia). We further wanted to determine the incidence of HF events and its consequences in these patient populations., Methods and Results: International retrospective Postgraduate Course in Heart Failure registry for patients hospitalized with COVID-19 and CArdioVascular disease and/or risk factors (arterial hypertension, diabetes, or dyslipidaemia) was performed in 28 centres from 15 countries (PCHF-COVICAV). The primary endpoint was in-hospital mortality. Of 1974 patients hospitalized with COVID-19, 1282 had cardiovascular disease and/or risk factors (median age: 72 [interquartile range: 62-81] years, 58% male), with HF being present in 256 [20%] patients. Overall in-hospital mortality was 25% (n = 323/1282 deaths). In-hospital mortality was higher in patients with a history of HF (36%, n = 92) compared with non-HF patients (23%, n = 231, odds ratio [OR] 1.93 [95% confidence interval: 1.44-2.59], P < 0.001). After adjusting, HF remained associated with in-hospital mortality (OR 1.45 [95% confidence interval: 1.01-2.06], P = 0.041). Importantly, 186 of 1282 [15%] patients had an acute HF event during hospitalization (76 [40%] with de novo HF), which was associated with higher in-hospital mortality (89 [48%] vs. 220 [23%]) than in patients without HF event (OR 3.10 [2.24-4.29], P < 0.001)., Conclusions: Hospitalized COVID-19 patients with HF are at increased risk for in-hospital death. In-hospital worsening of HF or acute HF de novo are common and associated with a further increase in in-hospital mortality., (© 2021 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Objectives: The purpose of this study was to evaluate the prognostic value of staging right heart failure (RHF) in patients with significant secondary tricuspid regurgitation (TR)., Background: Right ventricular dysfunction (RVD), defined as tricuspid annular plane systolic excursion <17 mm and clinical signs of RHF, defined as New York Heart Association functional class ≥II, peripheral edema, or use of diuretics, do not always coincide in patients with significant secondary TR and may have different prognostic implications., Methods: A total of 1,311 patients with significant secondary TR (median age: 71 [interquartile range: 62 to 78] years; 50% male) were divided into 4 RHF Stages according to the presence or absence of RVD and clinical signs of RHF: Stage 1 was defined as no RVD and no signs of RHF; Stage 2 indicated RVD but no signs of RHF; Stage 3 included RVD and signs of RHF; Stage 4 was defined as RVD and refractory signs of RHF at rest. Five-year mortality rates were compared across the 4 Stages of RHF, and the independent associates of mortality were identified by using multivariate Cox proportional hazards models., Results: A total of 101 patients (8%) were classified as Stage 1, 124 (10%) as Stage 2, 683 (52%) as Stage 3, and 403 (31%) as Stage 4. Patients in higher Stages of RHF had more comorbidities and worse renal and left ventricular systolic function. Cumulative 5-year survival was 54%. RHF Stages 3 and 4 were independently associated with increased mortality compared to Stage 1 (hazard ratio: 2.110 [95% confidence interval (CI): 1.163 to 3.828] and 3.318 [95% CI: 1.795 to 6.133], respectively)., Conclusions: In patients with significant secondary TR, higher Stages of RHF are independently associated with all-cause mortality at long-term follow-up., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)