One-Year Outcomes After Transcatheter Insertion of an Interatrial Shunt Device for the Management of Heart Failure With Preserved Ejection Fraction

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, Dirk J van Veldhuisen, Piotr Ponikowski, Frank E Silvestry, Dan Burkhoff, Christopher Hayward, 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, Dirk J van Veldhuisen, Piotr Ponikowski, Frank E Silvestry, Dan Burkhoff, Christopher Hayward

Abstract

Background: 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.

Methods and results: 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 (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.

Conclusions: 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.

Clinical trial registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01913613.

Keywords: heart failure; hemodynamics; physiology; therapeutics.

© 2016 The Authors.

Figures

Figure 1.
Figure 1.
A, Bar graph represents the effects of interatrial septal shunt device implantation on New York Heart Association (NYHA) class (n=60), (B) Minnesota Living with Heart Failure Score (MLWHF; n=60), and (C) 6-min walk distance (6MWD; n=55). **P<0.01, ***P<0.001 vs baseline. B and C, Data represent mean±SD.
Figure 2.
Figure 2.
Bar graphs representing (A) left ventricular ejection fraction (LVEF; n=53), (B) right ventricular ejection fraction (RVEF; n=47), (C) left ventricular end-diastolic volume index (LVEDVI; n=53), (D) right ventricular end-diastolic index (RVEDVI; n=48), (E) left atrial volume index (LAVI; n=53), and (F) right atrial volume index (RAVI; n=47). *P<0.05, **P<0.01, ***P<0.001 vs baseline. Data are mean±SD.
Figure 3.
Figure 3.
Bar graph showing workload indexed peak exertion wedge pressure before and after interatrial shunt device placement (n=16). *P<0.05, **P<0.01 vs baseline. Data are mean±SD. PCWP indicates pulmonary capillary wedge pressure.

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