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The regulatory landscape for device-based heart failure (HF) therapies has seen a major shift in the last 7 years. In 2013, the U.S. Food and Drug Administration released guidance for early feasibility and first-in-human studies, thereby encouraging device innovation, and in 2016 the U.S. Congress authorized the Breakthrough Devices Program to expedite access for Americans to innovative devices indicated for diagnosis and treatment of serious illnesses, such as HF. Since December 2016, there has been an increase in the number of HF devices for which manufacturers are seeking approval through the breakthrough designation pathway. This has led to a rapid uptake in the development and evaluation of device-based HF therapies. This article reviews the current and future landscape of device therapies for chronic HF and associated comorbidities and the regulatory environment that is driving current and future innovation. [ABSTRACT FROM AUTHOR]

Background: Tricuspid regurgitation (TR) is a common valve disease that has a significant impact on patients' quality of life., Objectives: This study sought to report the final 3-year outcomes of tricuspid transcatheter edge-to-edge repair (T-TEER) with the TriClip (Abbott) implant from the TRILUMINATE (TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR) study for the treatment of severe symptomatic TR., Methods: The TRILUMINATE study (N = 98 subjects) is an international, prospective, single-arm, multicenter study to investigate the safety and performance of T-TEER with the TriClip implant in patients with symptomatic moderate or greater TR. Echocardiographic assessments were performed at a core laboratory., Results: At 3 years, TR was reduced to moderate or less in 79% of subjects, and a reduction of at least 1 grade was achieved in 92% of subjects. TR reduction achieved at 1 year was sustained through 3 years. Subjects also experienced an improvement in heart failure symptoms assessed by NYHA functional class and quality of life assessed by the Kansas City Cardiomyopathy Questionnaire at 3 years compared to baseline. The site-reported heart failure hospitalization rate decreased from 0.56 events/patient-year 1 year before device implantation to 0.14 events/patient-year 3 years after device implantation, representing a reduction of 75% (P < 0.0001)., Conclusions: In the longest follow-up to date of any T-TEER therapy, the TRILUMINATE study demonstrated that the TriClip procedure is both safe and effective, with sustained benefits at 3 years in subjects with symptomatic moderate or greater TR. (TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR [TRILUMINATE]; NCT03227757)., Competing Interests: Funding Support and Author Disclosures This study was supported by Abbott Structural Heart. Dr Nickenig has received research funding and honoraria from Abbott, Edwards Lifesciences, and Medtronic; and has participated in clinical trials with Abbott, Edwards Lifesciences, and Medtronic. Dr Lurz has served as a consultant for Abbott Structural Heart, Edwards Lifesciences, Medtronic, ReCor, and Occlutech. Dr Sorajja has served as a consultant for 4C Medical, Abbott Structural, Adona, Boston Scientific, Edwards Lifesciences, Foldax, GE Medical, GLG, Medtronic, Phillips, Siemens, WL Gore, vDyne, and xDot; and has received personal fees from Abbott Vascular (outside the submitted work). Dr von Bardeleben has received institutional research grants and speaker honorarium from Abbott Vascular and Edwards Lifesciences; and has received nonfinancial trial support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Lifetec, and Medtronic. Dr Sitges has served as a consultant for Abbott, Edwards Lifesciences, Metronic, and General Electric; has received speaker honoraria from Abbott, Edwards Lifesciences, Medtronic, and General Electric; and has received speaker honoraria and travel and grant support from Abbott. Dr Hausleiter has received speaker honoraria and research support from Abbott Vascular and Edwards Lifesciences. Dr Trochu has received speaker honoraria, travel support, and grant support from Abbott and Novartis; has received honoraria for lectures or advisory boards from Amgen, Bayer, and Resmed; and has been an unpaid member of the Corvia Medical Scientific Advisory Group. Dr Näbauer has received speaker honoraria from Abbott. Dr Heitkemper is an employee of Abbott. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, and Philips Healthcare; and has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)