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Published on: August 16, 2021
Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure: Rationale and Design of the Randomized
Ted Feldman1, Jan Komtebedde2, Daniel Burkhoff2
1From the NorthShore University Health System, Evanston Hospital, IL (T.F.); Corvia Medical Incorporated, Tewksbury, MA (J.K.); Columbia University Medical Center, New York Presbyterian Hospital, New York City, NY (D.B., M.S.M., M.B.L.); Harvard Clinical Research Institute, Boston University School of Public Health, MA (J.M.); Alfred Hospital and Baker IDI Heart and Diabetes Institute Melbourne, Australia (D.K.); Hospital of the University of Pennsylvania, Philadelphia (F.E.S.); National Heart and Lung Institute, Royal Brompton and Harefield Hospitals, Imperial College, London (J.G.F.C.); Wake Forest School of Medicine, Winston-Salem, NC (D.K.); University of Minnesota, Minneapolis (S.H.K.); University Medical Center Groningen, University of Groningen, The Netherlands (D.J.V.V.); Cardio Centrum Berlin, Academic Teaching Institution, Charité University Medicine Berlin, Germany (F.K.); Université de Nantes, Institut du thorax, Centre Hospitalier Universitaire Nantes, France (J.-N.T.); Division of Cardiology, Fondazione Cardiocentro Ticino, Lugano, Switzerland (A.A.); Department of Cardiology, Rigshospitalet, Copenhagen, Denmark (F.G.); August Universität, Gottingen, Germany (G.H.); Department of Cardiac Diseases, Military Hospital, Medical University, Wroclaw, Poland (P.P.); National and Kapodistian University of Athens, School of Medicine, Attikon University Hospital, Greece (G.F.); Division of Cardiology, Harvard Clinical Research Institute, Brigham and Women's Hospital, Boston, MA (L.M.); and Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL (S.J.S.). tfeldman@tfeldman.org.
Unlabelled:
Heart failure with preserved ejection fraction (HFpEF), a major public health problem with high morbidity and mortality rates, remains difficult to manage because of a lack of effective treatment options. Although HFpEF is a heterogeneous clinical syndrome, elevated left atrial pressure-either at rest or with exertion-is a common factor among all forms of HFpEF and one of the primary reasons for dyspnea and exercise intolerance in these patients. On the basis of clinical experience with congenital interatrial shunts in mitral stenosis, it has been hypothesized that the creation of a left-to-right interatrial shunt to decompress the left atrium (without compromising left ventricular filling or forward cardiac output) is a rational, nonpharmacological strategy for alleviating symptoms in patients with HFpEF. A novel transcatheter interatrial shunt device has been developed and evaluated in patients with HFpEF in single-arm, nonblinded clinical trials. These studies have demonstrated the safety and potential efficacy of the device. However, a randomized, placebo-controlled evaluation of the device is required to further evaluate its safety and efficacy in patients with HFpEF. In this article, we give the rationale for a therapeutic transcatheter interatrial shunt device in HFpEF, and we describe the design of REDUCE Elevated Left Atrial Pressure in Heart Failure (REDUCE LAP-HF I), the first randomized controlled trial of a device-based therapy to reduce left atrial pressure in HFpEF.
Clinical Trial Registration:
URL: http://www.clinicaltrials.gov. Unique identifier: NCT02600234.
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