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 VeldhuisenPiotr Ponikowski, Frank E. Silvestry, Dan Burkhoff, Christopher Hayward

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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.

Original languageEnglish
Article numbere003662
Number of pages6
JournalCirculation: Heart Failure
Volume9
Issue number12
DOIs
Publication statusPublished - Dec 2016
Externally publishedYes

Keywords

  • heart failure
  • hemodynamics
  • physiology
  • therapeutics

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