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 |
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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 > School of Cardiovascular & Metabolic Health |
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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