Device Therapy in Chronic Heart Failure: JACC State-of-the-Art Review

Marat Fudim; William T Abraham; Ralph Stephan von Bardeleben; JoAnn Lindenfeld; Piotr P Ponikowski; Husam M Salah; Muhammad Shahzeb Khan; Horst Sievert; Gregg W Stone; Stefan D Anker; Javed Butler

doi:10.1016/j.jacc.2021.06.040

Device Therapy in Chronic Heart Failure: JACC State-of-the-Art Review

J Am Coll Cardiol. 2021 Aug 31;78(9):931-956. doi: 10.1016/j.jacc.2021.06.040.

Authors

Affiliations

¹ Division of Cardiology, Duke University Medical Center, Durham, North Carolina, USA; Duke Clinical Research Institute, Durham, North Carolina, USA. Electronic address: [email protected].
² Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio, USA.
³ Department of Cardiology, Angiology, and Intensive Care, Medical Clinic, University Medical Center Mainz, Mainz, Germany.
⁴ Division of Cardiovascular Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
⁵ Centre for Heart Diseases, University Hospital, Wroclaw, Poland; Department of Heart Diseases, Medical University, Wroclaw, Poland.
⁶ Department of Medicine, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA.
⁷ Department of Medicine, University of Mississippi School of Medicine, Jackson, Mississippi, USA.
⁸ Cardiovascular Center Frankfurt, Frankfurt, Germany; Anglia Ruskin University, Chelmsford, United Kingdom.
⁹ Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA; Cardiovascular Research Foundation, New York, New York, USA.
¹⁰ Department of Cardiology, Charité Universitätsmedizin, Berlin, Germany; Berlin Institute of Health Center for Regenerative Therapies, Charité Universitätsmedizin, Berlin, Germany; German Centre for Cardiovascular Research partner site Berlin, Charité Universitätsmedizin, Berlin, Germany.
¹¹ Department of Medicine, University of Mississippi School of Medicine, Jackson, Mississippi, USA. Electronic address: [email protected].

Abstract

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.

Keywords: U.S. Food and Drug Administration; device therapy; heart failure.

Publication types

Research Support, N.I.H., Extramural
Review

MeSH terms

Device Approval
Equipment Design / trends*
Heart Failure* / epidemiology
Heart Failure* / therapy
Heart-Assist Devices / classification
Heart-Assist Devices / standards
Humans
Vereinigte Staaten

Grants and funding

K23 HL151744/HL/NHLBI NIH HHS/United States