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Background: Cerebral ischemic events have a major impact on morbidity and mortality after transcatheter aortic valve replacement (TAVR). Cerebral emboli protection devices might have the potential to reduce clinical ischemic events and improve overall TAVR outcome.
Methods: A total of 681 all-comer consecutive patients were prospectively enrolled. The Sentinel cerebral emboli protection device (Claret Medical Inc. CA, USA) is commercially available in Europe and was used in 25.6% (N=174) of patients, in 74.4% (N=507) TAVR was done without cerebral emboli protection. Neurological and clinical follow-up was done within seven days post procedure. The primary endpoint was a composite of all-cause mortality or all stroke according to Valve Academic Research Consortium (VARC)-2 criteria at seven days. Secondary endpoint was technical success of the device, defined as successful insertion and deployment of both filters at intended position.
Results: Patient baseline characteristics and aortic valve parameters were similar between groups. The Sentinel device was successfully positioned in 174/186 (93.5%) patients. With use of the Sentinel cerebral emboli protection device rate of disabling and non-disabling stroke was significantly reduced from 4.3% to 0.6% (p=0.02; odds ratio 0.13, 95% confidence interval 0.02 – 0.95). The primary safety endpoint, a composite of all-cause mortality or all-stroke, occurred significantly less frequent with 1.2% (N=2/174) in the Sentinel group compared to 6.7% (N=34/507) in the control group (p=0.01; odds ratio 0.16, 95% confidence interval 0.04-0.68). In multivariable analysis STS score for mortality (p<0.01), predilation (p=0.02) and TAVR without cerebral emboli protection (p=0.04) were independent predictors for the combined endpoint death or stroke.
Conclusions: In patients undergoing TAVR use of the Sentinel cerebral emboli protection device was associated with a high technical success and with a significantly lower rate of all-cause mortality or stroke within seven days compared with patients undergoing unprotected TAVR.
Moderated Poster Contributions
Interventional Cardiology Moderated Poster Theater, Poster Hall, Hall C
Saturday, March 18, 2017, 12:30 p.m.-12:40 p.m.
Session Title: Refining TAVR Outcomes
Abstract Category: 17. Interventional Cardiology: Aortic Valve Disease
Presentation Number: 1224M-03
- 2017 American College of Cardiology Foundation