• David M Kaye, Gerd Hasenfuß, 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, VeldhuisenDirk J vanDJDepartment 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, Th, Piotr Ponikowski, Frank E Silvestry, Dan Burkhoff, and Christopher Hayward.
• 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.). david.kaye@bakeridi.edu.au.
• Circ Heart Fail. 2016 Dec 1; 9 (12).

BackgroundHeart 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.Methods And ResultsPatients (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 (P<0.001), quality of life (Minnesota Living with Heart Failure score, P<0.001), and 6-minute walk distance (P<0.01). Echocardiography showed a small, stable reduction in left ventricular end-diastolic volume index (P<0.001), with a concomitant small stable increase in the right ventricular end-diastolic volume index (P<0.001). Invasive hemodynamic studies performed in a subset of patients demonstrated a sustained reduction in the workload corrected exercise pulmonary capillary wedge pressure (P<0.01). Survival at 1 year was 95%, and there was no evidence of device-related complications.ConclusionsThese 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.Clinical Trial RegistrationURL: https://www.clinicaltrials.gov. Unique identifier: NCT01913613.© 2016 The Authors.

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