Transcatheter interatrial shunt device for the treatment of heart failure

Ted Feldman*, Jan Komtebedde, Daniel Burkhoff, Joseph Massaro, Mathew S. Maurer, Martin B. Leon, David Kaye, Frank E. Silvestry, John G.F. Cleland, Dalane Kitzman, Spencer H. Kubo, Dirk J. Van Veldhuisen, Franz Kleber, Jean Noël Trochu, Angelo Auricchio, Finn Gustafsson, Gerd Hasenfu, Piotr Ponikowski, Gerasimos Filippatos, Laura MauriSanjiv J. Shah

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

30 Scopus citations

Abstract

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.

Original languageEnglish (US)
JournalCirculation: Heart Failure
Volume9
Issue number7
DOIs
StatePublished - Jul 1 2016

Keywords

  • atrial septum
  • cardiac output
  • heart failure
  • randomized controlled trial

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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