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Feasibility and efficacy of transcatheter interatrial shunt devices for chronic heart failure : a systematic review and meta‐analysis

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Lauder, Lucas, Pereira, Tiago V., Degenhardt, Markus C., Ewen, Sebastian, Kulenthiran, Saarraaken, Coats, Andrew J. S., Böhm, Michael, Anker, Stefan D., da Costa, Bruno R. and Mahfoud, Felix (2021) Feasibility and efficacy of transcatheter interatrial shunt devices for chronic heart failure : a systematic review and meta‐analysis. European Journal of Heart Failure, 23 (11). pp. 1960-1970. doi:10.1002/ejhf.2360 ISSN 1388-9842.

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Official URL: https://doi.org/10.1002/ejhf.2360

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Abstract

Aims: To assess the feasibility and efficacy of interatrial shunt devices (IASD) for the treatment of chronic heart failure (CHF). Methods and results: MEDLINE and the Cochrane Central Register of Controlled Trials from inception until April 2021 were searched for prospective studies investigating dedicated transcatheter IASD for the treatment of CHF. Standardised mean differences were calculated for the within‐group changes before and after implantation of the IASD. The pre‐defined primary outcome was change in 6‐min walking distance (6MWD) from baseline to 12 months. Other outcomes were change in New York Heart Association class, health‐related quality of life (HRQoL), echocardiographic and haemodynamic data, device performance and safety. Subgroup analyses were crude univariable meta‐regression analyses. Six studies (five single‐arm open‐label studies, one sham‐controlled trial) were included. In these, 226 patients underwent IASD implantation using four different devices. From baseline to 12 months, 6MWD increased by 28.1 m [95% confidence interval (CI) 10.9–45.3] with no evidence for a difference between devices (P for interaction = 0.66) and patients with left ventricular ejection fraction (LVEF) >40% or ≤40% (P for interaction = 0.21). At 12 months, HRQoL improved by 17.7 points (95% CI 10.8–24.6) and pulmonary capillary wedge pressure (PCWP) decreased by 2.0 mmHg (95% CI −3.6 to −0.4). There were no changes in LVEF or N‐terminal pro brain natriuretic peptide during follow‐up. Shunt patency ranged from 50% for the first‐generation v‐Wave to 100% for the Corvia IASD II and the second‐generation v‐Wave system, respectively. The summary risk of serious adverse device‐related effects was 8% (95% CI 1–20) at 12 months. Conclusions: Interatrial shunt device implantation in CHF is feasible and associates with improved submaximal exercise capacity (measured by 6MWD) and HRQoL, and reductions in PCWP.

Item Type: Journal Article
Subjects: R Medicine > RC Internal medicine
R Medicine > RD Surgery
Divisions: Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
SWORD Depositor: Library Publications Router
Library of Congress Subject Headings (LCSH): Cardiac catheterization , Heart valves, Heart failure -- Treatment, Arteriovenous shunts, Surgical
Journal or Publication Title: European Journal of Heart Failure
Publisher: John Wiley & Sons Ltd.
ISSN: 1388-9842
Official Date: 5 November 2021
Dates:
DateEvent
5 November 2021Published
6 October 2021Accepted
Volume: 23
Number: 11
Page Range: pp. 1960-1970
DOI: 10.1002/ejhf.2360
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access (Creative Commons)
Date of first compliant deposit: 8 November 2021
Date of first compliant Open Access: 9 November 2021
RIOXX Funder/Project Grant:
Project/Grant IDRIOXX Funder NameFunder ID
Chevening Scholarship Program Foreign and Commonwealth Officehttp://dx.doi.org/10.13039/501100000617

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