Τίτλος:
Transcatheter interatrial shunt device for the treatment of heart failure
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
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. © 2016 American Heart Association, Inc.
Συγγραφείς:
Feldman, T.
Komtebedde, J.
Burkhoff, D.
Massaro, J.
Maurer, M.S.
Leon, M.B.
Kaye, D.
Silvestry, F.E.
Cleland, J.G.F.
Kitzman, D.
Kubo, S.H.
Van Veldhuisen, D.J.
Kleber, F.
Trochu, J.-N.
Auricchio, A.
Gustafsson, F.
Hasenfu, G.
Ponikowski, P.
Filippatos, G.
Mauri, L.
Shah, S.J.
Περιοδικό:
Circulation: Heart Failure
Εκδότης:
Lippincott Williams and Wilkins
Λέξεις-κλειδιά:
Article; cardiac implant; clinical trial (topic); decompression; device safety; equipment design; exercise; heart catheter; heart failure; heart left atrium; heart left atrium pressure; heart left ventricle ejection fraction; human; outcome assessment; pathophysiology; prevalence; priority journal; randomized controlled trial (topic); study design; transcatheter interatrial shunt device; adverse effects; clinical protocol; clinical trial; controlled study; convalescence; devices; Europe; heart assist device; heart atrium function; heart atrium pressure; heart catheterization; heart failure; heart left ventricle function; heart stroke volume; methodology; multicenter study; prospective study; prosthesis design; randomized controlled trial; single blind procedure; time factor; treatment outcome; United States, Atrial Function, Left; Atrial Pressure; Cardiac Catheterization; Clinical Protocols; Europe; Heart Failure; Heart-Assist Devices; Humans; Prospective Studies; Prosthesis Design; Recovery of Function; Research Design; Single-Blind Method; Stroke Volume; Time Factors; Treatment Outcome; United States; Ventricular Function, Left
DOI:
10.1161/CIRCHEARTFAILURE.116.003025
