Impact of a Two-Filter Cerebral Embolic Protection Device on the Complexity and Risk of Transcatheter Aortic Valve Replacement.

ABSTRACT

BACKGROUND: There is a growing use of cerebral protection devices in patients undergoing transcatheter aortic valve replacement (TAVR). We aimed to analyze if the use of these devices itself has an impact on the complexity and the risk of TAVR. METHODS: Between February 2016 and July 2017, 391 patients underwent transfemoral TAVR with Medtronic CoreValve Evolut R (n = 196) or Edwards Sapien 3 (n = 195). In 39 patients, the Claret Sentinel™ embolic protection device (CS-EPD) was used. Prospectively collected data were retrospectively analyzed, comparing fluoroscopy/operation time, amount of contrast used, vascular events, and postprocedural renal function in TAVR patients with (n = 39) and without (n = 352) CS-EPD. RESULTS: The CS-EPD was placed through the right radial (n = 35) or brachial (n = 4) artery. Procedural success rate defined as correct deployment and retraction of both filters was 94.9%. No device-related vascular complications occurred. TAVR patients with CS-EPD showed a significantly higher total operation time, total fluoroscopy time, and amount of used contrast (85.4 ± 39.3 vs. 64 ± 29.8 minutes, p = 0.002; 20.7 ± 9.3 vs. 13.7 ± 7 minutes, p ≤ 0.001; 133.7 ± 42.6 vs. 109.7 ± 44.5 mL, p = 0.001). Comparing the initial third of patients receiving a CS-EPD with the last third of CS-EPD cases, procedural time had decreased significantly (102.5 ± 34.9 vs. 67 ± 11.9; p = 0.002). There were no differences in postprocedural renal failure (p = 0.80). CONCLUSION: Our data add evidence that the application of the CS-EPD is not associated with an additional risk for the patient. Although procedural time and amount of contrast are still higher when using the CS-EPD, there were no device-related complications or increased incidence of renal failure.