One-Year Outcomes After Transcatheter Insertion of an Interatrial Shunt Device for the Management of Heart Failure With Preserved Ejection Fraction
Identifieur interne : 002229 ( Pmc/Curation ); précédent : 002228; suivant : 002230One-Year Outcomes After Transcatheter Insertion of an Interatrial Shunt Device for the Management of Heart Failure With Preserved Ejection Fraction
Auteurs : David M. Kaye ; Gerd Hasenfu ; Petr Neuzil ; Martijn C. Post ; Robert Doughty ; Jean-Noël Trochu ; Adam Kolodziej ; Ralf Westenfeld ; Martin Penicka ; Mark Rosenberg ; Antony Walton ; David Muller ; Darren Walters ; Jorg Hausleiter ; Philip Raake ; Mark C. Petrie ; Martin Bergmann ; Guillaume Jondeau ; Ted Feldman ; Dirk J. Van Veldhuisen ; Piotr Ponikowski ; Frank E. Silvestry ; Dan Burkhoff ; Christopher HaywardSource :
- Circulation. Heart Failure [ 1941-3289 ] ; 2016.
Abstract
Supplemental Digital Content is available in the text.
Url:
DOI: 10.1161/CIRCHEARTFAILURE.116.003662
PubMed: 27852653
PubMed Central: 5175994
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Post</name></author><author><name sortKey="Doughty, Robert" sort="Doughty, Robert" uniqKey="Doughty R" first="Robert" last="Doughty">Robert Doughty</name></author><author><name sortKey="Trochu, Jean Noel" sort="Trochu, Jean Noel" uniqKey="Trochu J" first="Jean-Noël" last="Trochu">Jean-Noël Trochu</name></author><author><name sortKey="Kolodziej, Adam" sort="Kolodziej, Adam" uniqKey="Kolodziej A" first="Adam" last="Kolodziej">Adam Kolodziej</name></author><author><name sortKey="Westenfeld, Ralf" sort="Westenfeld, Ralf" uniqKey="Westenfeld R" first="Ralf" last="Westenfeld">Ralf Westenfeld</name></author><author><name sortKey="Penicka, Martin" sort="Penicka, Martin" uniqKey="Penicka M" first="Martin" last="Penicka">Martin Penicka</name></author><author><name sortKey="Rosenberg, Mark" sort="Rosenberg, Mark" uniqKey="Rosenberg M" first="Mark" last="Rosenberg">Mark Rosenberg</name></author><author><name sortKey="Walton, Antony" sort="Walton, Antony" uniqKey="Walton A" first="Antony" last="Walton">Antony Walton</name></author><author><name sortKey="Muller, David" sort="Muller, David" uniqKey="Muller D" first="David" last="Muller">David Muller</name></author><author><name sortKey="Walters, Darren" sort="Walters, Darren" uniqKey="Walters D" first="Darren" last="Walters">Darren Walters</name></author><author><name sortKey="Hausleiter, Jorg" sort="Hausleiter, Jorg" uniqKey="Hausleiter J" first="Jorg" last="Hausleiter">Jorg Hausleiter</name></author><author><name sortKey="Raake, Philip" sort="Raake, Philip" uniqKey="Raake P" first="Philip" last="Raake">Philip Raake</name></author><author><name sortKey="Petrie, Mark C" sort="Petrie, Mark C" uniqKey="Petrie M" first="Mark C." last="Petrie">Mark C. 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Kaye</name></author><author><name sortKey="Hasenfu, Gerd" sort="Hasenfu, Gerd" uniqKey="Hasenfu G" first="Gerd" last="Hasenfu">Gerd Hasenfu</name></author><author><name sortKey="Neuzil, Petr" sort="Neuzil, Petr" uniqKey="Neuzil P" first="Petr" last="Neuzil">Petr Neuzil</name></author><author><name sortKey="Post, Martijn C" sort="Post, Martijn C" uniqKey="Post M" first="Martijn C." last="Post">Martijn C. 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<front><journal-meta><journal-id journal-id-type="nlm-ta">Circ Heart Fail</journal-id><journal-id journal-id-type="iso-abbrev">Circ Heart Fail</journal-id><journal-id journal-id-type="publisher-id">HHF</journal-id><journal-title-group><journal-title>Circulation. Heart Failure</journal-title></journal-title-group><issn pub-type="ppub">1941-3289</issn><issn pub-type="epub">1941-3297</issn><publisher><publisher-name>Lippincott Williams & Wilkins</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">27852653</article-id><article-id pub-id-type="pmc">5175994</article-id><article-id pub-id-type="art-access-id">00004</article-id><article-id pub-id-type="doi">10.1161/CIRCHEARTFAILURE.116.003662</article-id><article-categories><subj-group subj-group-type="hwp-journal-coll"><subject>10094</subject><subject>10155</subject></subj-group><subj-group subj-group-type="heading"><subject>Original Articles</subject></subj-group></article-categories><title-group><article-title>One-Year Outcomes After Transcatheter Insertion of an Interatrial Shunt Device for the Management of Heart Failure With Preserved Ejection Fraction</article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name><surname>Kaye</surname><given-names>David M.</given-names></name><degrees>MD, PhD</degrees></contrib><contrib contrib-type="author"><name><surname>Hasenfuß</surname><given-names>Gerd</given-names></name><degrees>MD</degrees></contrib><contrib contrib-type="author"><name><surname>Neuzil</surname><given-names>Petr</given-names></name><degrees>MD</degrees></contrib><contrib contrib-type="author"><name><surname>Post</surname><given-names>Martijn C.</given-names></name><degrees>MD</degrees></contrib><contrib contrib-type="author"><name><surname>Doughty</surname><given-names>Robert</given-names></name><degrees>MD</degrees></contrib><contrib contrib-type="author"><name><surname>Trochu</surname><given-names>Jean-Noël</given-names></name><degrees>MD, PhD</degrees></contrib><contrib contrib-type="author"><name><surname>Kolodziej</surname><given-names>Adam</given-names></name><degrees>MD</degrees></contrib><contrib contrib-type="author"><name><surname>Westenfeld</surname><given-names>Ralf</given-names></name><degrees>MD</degrees></contrib><contrib contrib-type="author"><name><surname>Penicka</surname><given-names>Martin</given-names></name><degrees>MD</degrees></contrib><contrib contrib-type="author"><name><surname>Rosenberg</surname><given-names>Mark</given-names></name><degrees>MD, PhD</degrees></contrib><contrib contrib-type="author"><name><surname>Walton</surname><given-names>Antony</given-names></name><degrees>MD</degrees></contrib><contrib contrib-type="author"><name><surname>Muller</surname><given-names>David</given-names></name><degrees>MD</degrees></contrib><contrib contrib-type="author"><name><surname>Walters</surname><given-names>Darren</given-names></name><degrees>MD</degrees></contrib><contrib contrib-type="author"><name><surname>Hausleiter</surname><given-names>Jorg</given-names></name><degrees>MD</degrees></contrib><contrib contrib-type="author"><name><surname>Raake</surname><given-names>Philip</given-names></name><degrees>MD</degrees></contrib><contrib contrib-type="author"><name><surname>Petrie</surname><given-names>Mark C.</given-names></name><degrees>MD</degrees></contrib><contrib contrib-type="author"><name><surname>Bergmann</surname><given-names>Martin</given-names></name><degrees>MD, PhD</degrees></contrib><contrib contrib-type="author"><name><surname>Jondeau</surname><given-names>Guillaume</given-names></name><degrees>MD</degrees></contrib><contrib contrib-type="author"><name><surname>Feldman</surname><given-names>Ted</given-names></name><degrees>MD</degrees></contrib><contrib contrib-type="author"><name><surname>van Veldhuisen</surname><given-names>Dirk J.</given-names></name><degrees>MD</degrees></contrib><contrib contrib-type="author"><name><surname>Ponikowski</surname><given-names>Piotr</given-names></name><degrees>MD, PhD</degrees></contrib><contrib contrib-type="author"><name><surname>Silvestry</surname><given-names>Frank E.</given-names></name><degrees>MD</degrees></contrib><contrib contrib-type="author"><name><surname>Burkhoff</surname><given-names>Dan</given-names></name><degrees>MD, PhD</degrees></contrib><contrib contrib-type="author"><name><surname>Hayward</surname><given-names>Christopher</given-names></name><degrees>MD</degrees></contrib><aff>Department of Cardiology, Alfred Hospital, Melbourne, Victoria, Australia (D.M.K., A.W.); Georg-August Universität, Gottingen, Germany (G.H.); Na Homolce Hospital, Prague, Czech Republic (P.N.); St Antonius Ziekenhuis, Nieuwegein, The Netherlands (M.C.P.); University of Auckland, New Zealand (R.D.); CHU de Nantes, France (J.-N.T.); Fourth Military Hospital, Wroclaw, Poland (A.K.); Universität Klinikum Dusseldorf, Germany (R.W.); Cardiovascular Center Aalst, Belgium (M.P.); University Medical Center Schleswig-Holstein, Kiel, Germany (M.R.); Department of Cardiology, St Vincent’s Hospital, Sydney, New South Wales, Australia (D.M., C.H.); Department of Cardiology, Prince Charles Hospital, Brisbane, Queensland, Australia (D.W.); Klinikum Großhadern, Munich, Germany (J.H.); Internal Medicine, University of Heidelberg, Germany (P.R.); Golden Jubilee Hospital, Glasgow, Great Britain (M.C.P.); Cardiologicum Hamburg, Germany (M.B.); Bichat Hospital, INSERM, Paris, France (G.J.); Northshore University Health System, Evanston, IL (T.F.); University Medical Centre, Groningen, Netherlands (D.J.v.V.); Wroclaw Medical University, Czech Republic (P.P.); Hospital of the University of Pennsylvania, Philadelphia (F.E.S.); and Columbia University, New York, NY (D.B.).</aff></contrib-group><author-notes><corresp id="c1">Correspondence to David M. Kaye, MD, PhD, Department of Cardiology, Alfred Hospital, Commercial Rd, Melbourne 3004, Victoria, Australia. E-mail <email xlink:href="david.kaye@bakeridi.edu.au">david.kaye@bakeridi.edu.au</email></corresp></author-notes><pub-date pub-type="ppub"><month>12</month><year>2016</year></pub-date><pub-date pub-type="epub"><day>16</day><month>11</month><year>2016</year></pub-date><volume>9</volume><issue>12</issue><fpage>e003662</fpage><lpage>e003662</lpage><history><date date-type="received"><day>21</day><month>10</month><year>2016</year></date><date date-type="accepted"><day>4</day><month>11</month><year>2016</year></date></history><permissions><copyright-statement>© 2016 The Authors.</copyright-statement><copyright-year>2016</copyright-year><license license-type="open-access"><license-p><italic>Circulation: Heart Failure</italic> is published on behalf of the American Heart Association, Inc., by Wolters Kluwer Health, Inc. This is an open access article under the terms of the <ext-link ext-link-type="uri" xlink:href="https://creativecommons.org/licenses/by-nc-nd/4.0/">Creative Commons Attribution Non-Commercial-NoDervis</ext-link> License, which permits use, distribution, and reproduction in any medium, provided that the original work is properly cited, the use is noncommercial, and no modifications or adaptations are made.</license-p></license></permissions><self-uri xlink:type="simple" xlink:href="hhf-9-e003662.pdf"></self-uri><abstract abstract-type="toc"><p>Supplemental Digital Content is available in the text.</p></abstract><abstract><sec><title>Background—</title><p>Heart failure with preserved ejection fraction has a complex pathophysiology and remains a therapeutic challenge. Elevated left atrial pressure, particularly during exercise, is a key contributor to morbidity and mortality. Preliminary analyses have demonstrated that a novel interatrial septal shunt device that allows shunting to reduce the left atrial pressure provides clinical and hemodynamic benefit at 6 months. Given the chronicity of heart failure with preserved ejection fraction, evidence of longer-term benefit is required.</p></sec><sec><title>Methods and Results—</title><p>Patients (n=64) with left ventricular ejection fraction ≥40%, New York Heart Association class II–IV, elevated pulmonary capillary wedge pressure (≥15 mm Hg at rest or ≥25 mm Hg during supine bicycle exercise) participated in the open-label study of the interatrial septal shunt device. One year after interatrial septal shunt device implantation, there were sustained improvements in New York Heart Association class (<italic>P</italic><0.001), quality of life (Minnesota Living with Heart Failure score, <italic>P</italic><0.001), and 6-minute walk distance (<italic>P</italic><0.01). Echocardiography showed a small, stable reduction in left ventricular end-diastolic volume index (<italic>P</italic><0.001), with a concomitant small stable increase in the right ventricular end-diastolic volume index (<italic>P</italic><0.001). Invasive hemodynamic studies performed in a subset of patients demonstrated a sustained reduction in the workload corrected exercise pulmonary capillary wedge pressure (<italic>P</italic><0.01). Survival at 1 year was 95%, and there was no evidence of device-related complications.</p></sec><sec><title>Conclusions—</title><p>These results provide evidence of safety and sustained clinical benefit in heart failure with preserved ejection fraction patients 1 year after interatrial septal shunt device implantation. Randomized, blinded studies are underway to confirm these observations.</p></sec><sec><title>Clinical Trial Registration—</title><p>URL: <ext-link ext-link-type="uri" xlink:href="https://www.clinicaltrials.gov">https://www.clinicaltrials.gov</ext-link>. Unique identifier: NCT01913613.</p></sec></abstract><kwd-group><kwd>heart failure</kwd><kwd>hemodynamics</kwd><kwd>physiology</kwd><kwd>therapeutics</kwd></kwd-group><custom-meta-group><custom-meta><meta-name>OPEN-ACCESS</meta-name><meta-value>TRUE</meta-value></custom-meta></custom-meta-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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