One-year outcomes after transcatheter insertion of an interatrial shunt device for the management of heart failure with preserved ejection fraction

Kaye, D. M. et al. (2016) One-year outcomes after transcatheter insertion of an interatrial shunt device for the management of heart failure with preserved ejection fraction. Circulation: Heart Failure, 9(12), e003662. (doi: 10.1161/CIRCHEARTFAILURE.116.003662) (PMID:27852653) (PMCID:PMC5175994)

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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.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Petrie, Professor Mark
Authors: Kaye, D. M., Hasenfuß, G., Neuzil, P., Post, M. C., Doughty, R., Trochu, J.-N., Kolodziej, A., Westenfeld, R., Penicka, M., Rosenberg, M., Walton, A., Muller, D., Walters, D., Hausleiter, J., Raake, P., Petrie, M. C., Bergmann, M., Jondeau, G., Feldman, T., van Veldhuisen, D. J., Ponikowski, P., Silvestry, F. E., Burkhoff, D., and Hayward, C.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cardiovascular and Medical Sciences
Journal Name:Circulation: Heart Failure
Publisher:American Heart Association
ISSN:1941-3289
ISSN (Online):1941-3297
Published Online:16 November 2016
Copyright Holders:Copyright © 2016 The Authors
First Published:First published in Circulation: Heart Failure 9(12):e003662
Publisher Policy:Reproduced under a Creative Commons License

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