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.
One-Year Outcomes After Transcatheter Insertion of an Interatrial Shunt Device for the Management of Heart Failure With Preserved Ejection Fraction
DM Kaye, G Hasenfuss, P Neuzil, MC Post, R Doughty, JN Trochu, A Kolodziej, R Westenfeld, M Penicka, M Rosenberg, A Walton, D Muller, D Walters, J Hausleiter, P Raake, MC Petrie, M Bergmann, G Jondeau, T Feldman, DJ Veldhuisen, P Ponikowski, FE Silvestry, D Burkhoff and C Hayward
Circ Heart Fail 2016;9