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Kaye, David M.; Hasenfuß, Gerd; Neuzil, Petr; Post, Martijn C.; Doughty, Robert; Trochu, Jean-Noël; Kolodziej, Adam; Westenfeld, Ralf; Penicka, Martin; Rosenberg, Mark; Walton, Antony; Muller, David; Walters, Darren; Hausleiter, Jörg; Raake, Philip; Petrie, Mark C.; Bergmann, Martin; Jondeau, Guillaume; Feldman, Ted; Veldhuisen, Dirk J. van; Ponikowski, Piotr; Silvestry, Frank E.; Burkhoff, Dan; Hayward, Christopher (2016): One-Year Outcomes After Transcatheter Insertion of an Interatrial Shunt Device for the Management of Heart Failure With Preserved Ejection Fraction. In: Circulation-Heart Failure, Vol. 9, No. 12, UNSP e003662
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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.