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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.

Transcatheter aortic valve implantation (TAVI) is an established treatment strategy in aortic valve disease. Infolding, as a nonuniform expansion of the prosthesis leading to introflection of part of the device circumference, is a complication specific to self-expandable prostheses. The aim of the study is to determine incidence, predictors, treatment strategy, and outcomes of infolding during Medtronic Evolut TAVI (Minneapolis, MN, US). Between January 2018 and March 2022, all patients treated with Evolut TAVI were included in a multicenter observational retrospective study. According to the occurrence of infolding, the enrolled cohort was divided into 2 groups; periprocedural characteristics and 30-day outcomes were compared. A total of 1,470 patients were included; 23 infolding cases (1.6%) were detected. Preprocedural imaging showed larger aortic anatomy and greater calcium burden in the infolding group. Infolding occurred mostly with Evolut Pro+ and size 34 mm and was diagnosed before full prosthesis release in 78.3%. The rate of moderate-to-severe paravalvular regurgitation was higher in the infolding group (21.7% vs 1.9%, p <0.001). Short-term follow-up showed greater all-cause and cardiovascular mortality (respectively, 4.3% vs 0.7% and 4.3% vs 0.6%, p <0.05) and higher rate of pacemaker implantation (33.3% vs 15.7%, p = 0.042) in case of infolding. High right cusp calcium score and resheathing maneuvers were independent predictors of infolding. In conclusion, prosthesis infolding is a TAVI complication burdened by worse cardiovascular outcomes. Prompt intraprocedural infolding diagnosis is pivotal, especially in case of great native valve calcium burden and resheathing maneuvers, to safely overcome this complication by prosthesis recapture or postdilation., Competing Interests: Declaration of competing interest Dr. Agostoni has received consulting fees from: Abbott, AorticLab, Boston Scientific, Cordis, iVascular, Medtronic, Neovasc, Seven Sons, Teleflex, and Terumo. Dr. Veulemans has received consulting fees, travel expenses or study honoraria from Medtronic, Edwards Lifesciences, and Boston Scientific. The remaining authors have no competing interests to declare., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Competing Interests: Stijn Lochy, Adel Aminian, Edgard Prihadi, and Philippe Unger have received consultancy fees from Abbott. The other authors had no conflicts to declare.

Background: Oral anticoagulation therapy (OAC) remains the gold standard for ischaemic stroke prevention in patients with non-valvular atrial fibrillation (NVAF) and elevated stroke risk. Percutaneous left atrial appendage occlusion (LAAO) has emerged as a potential alternative for stroke prevention in patients who cannot tolerate OAC. Although no randomized data is available, recurrent stroke in NVAF-patients, while on adequate OAC, is regarded as a treatment failure and therefore is considered as a potential indication for LAAO, based upon expert opinion., Methods/objectives: A multicentre retrospective cohort study evaluating efficacy, safety and mortality of LAAO in NVAF-patients presenting with recurrent ischaemic stroke, after excluding other plausible causes., Results: Fifteen LAAO have been performed in NVAF-patients with recurrent stroke despite ongoing OAC, after exclusion of other plausible causes. Mean age was 78.1 ± 5.8 years, mean CHA 2 DS 2 -VASc-score = 6 ± 1.2 and mean HAS-BLED-score = 5 ± 1.2. Successful implantation was achieved in all patients (73% Amplatzer device and 27% Watchman device), without any access-related complications and only one procedure/device-related complication (device embolization) was reported. In all but four patients, OAC was continued at long term after LAAO. No haemorrhagic strokes and only two ischaemic strokes were observed. During follow-up three patients died, all due to non-atrial fibrillation or non-device-related causes., Conclusions: In NVAF-patients at high risk for stroke presenting with recurrent stroke despite adequate OAC, LAAO may be considered an adjunctive, but not alternative treatment to OAC with high feasibility and safety., Abbreviations: AF: atrial fibrillation; ESC: European Society of Cardiology; INR: international normalized ratio; LAA: left atrial appendage; LAAO: left atrial appendage occlusion; NOAC: non-vitamin K oral anticoagulants; NVAF: non-valvular atrial fibrillation; OAC: oral anticoagulation; RS: recurrent (ischaemic) stroke; SD: standard deviation; TIA: transient ischaemic attack; TOE: transoesophageal echocardiography; TTE: transthoracic echocardiography; VKA: vitamin K antagonists.

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: In this retrospective observational study, we investigate outcome of patients treated with or without covered stent (CS) implantation in the management of coronary artery perforation (CAP) during coronary intervention., Background: CSs have shown to be effective devices to achieve acute hemostasis in large CAP. However, doubts have been raised regarding their long-term outcome., Methods: Data of 19 061 PCI procedures during a 10-year period were reviewed. Fifty-five cases of large CAP were withheld (Ellis type 2, 3 or cavity spilling). All medical and procedural records of these cases were retrospectively reviewed., Results: Twenty-four (43.6%) patients were treated with CS implantation (15 polytetrafluoroethylene and 9 pericardium CSs). Twenty-six (47.3%) patients were managed without CS implantation, of whom five had unsuccessful delivery of a CS (stent delivery failure 17.2%). Although significantly more Ellis type-3 perforations were present in the CS group compared to the Non-CS group (75.0% vs 45.2%; P = 0.03), in-hospital mortality was not significantly different (8.3% vs 6.4%; [P = 0.79]). We observed a high rate of CS restenosis (29.2%) but a lower rate of CS thrombosis (4.2%). Despite these observations, 5-year MACE and all-cause mortality were not significantly different between CS and Non-CS group (respectively, 58.8% vs 50.0% (P = 0.26) and 26.7% vs 13.3% (P = 0.36))., Conclusion: Although deliverability of CSs was not flawless and a high rate of CS restenosis appeared, short- and long-term outcome were comparable between patients treated with or without CS. Therefore, CSs are justifiable in the treatment of CAP., (© 2018 Wiley Periodicals, Inc.)