Author + information
- Received May 8, 2017
- Revision received June 11, 2017
- Accepted June 20, 2017
- Published online November 20, 2017.
- Julia Seeger, MDa,
- Birgid Gonska, MDa,
- Markus Otto, MDb,
- Wolfgang Rottbauer, MDa and
- Jochen Wöhrle, MDa,∗ ()
- aDepartment of Internal Medicine II, Cardiology, University of Ulm, Ulm, Germany
- bDepartment of Neurology, University of Ulm, Ulm, Germany
- ↵∗Address for correspondence:
Prof. Dr. Jochen Wöhrle, Department of Cardiology, University of Ulm, Albert-Einstein-Allee 23, 89081 Ulm, Germany.
Objectives The aim of this study was to evaluate the impact of cerebral embolic protection on stroke-free survival in patients undergoing transcatheter aortic valve replacement (TAVR).
Background Imaging data on cerebral embolic protection devices have demonstrated a significant reduction in number and volume of cerebral lesions.
Methods A total of 802 consecutive patients were enrolled. The Sentinel cerebral embolic protection device (Claret Medical Inc., Santa Rosa, California) was used in 34.9% (n = 280) of consecutive patients. In 65.1% (n = 522) of patients TAVR was performed in the identical setting except without cerebral embolic protection. Neurological follow-up was done within 7 days post-procedure. The primary endpoint was a composite of all-cause mortality or all-stroke according to Valve Academic Research Consortium-2 criteria within 7 days. Propensity score matching was performed to account for possible confounders.
Results Both filters of the device were successfully positioned in 280 of 305 (91.8%) consecutive patients. With use of cerebral embolic protection rate of disabling and nondisabling stroke was significantly reduced from 4.6% to 1.4% (p = 0.03; odds ratio: 0.29, 95% confidence interval: 0.10 to 0.93) in the propensity-matched population (n = 560). The primary endpoint occurred significantly less frequently, with 2.1% (n = 6 of 280) in the protected group compared with 6.8% (n = 19 of 280) in the control group (p = 0.01; odds ratio: 0.30; 95% confidence interval: 0.12 to 0.77). In multivariable analysis Society of Thoracic Surgeons score for mortality (p = 0.02) and TAVR without protection (p = 0.02) were independent predictors for the primary endpoint.
Conclusions In patients undergoing TAVR use of a cerebral embolic protection device demonstrated a significant higher rate of stroke-free survival compared with unprotected TAVR.
The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received May 8, 2017.
- Revision received June 11, 2017.
- Accepted June 20, 2017.
- 2017 American College of Cardiology Foundation