TY - JOUR AU - Voss, Stephanie; Deutsch, Marcus-André; Schechtl, Johanna; Erlebach, Magdalena; Sideris, Konstantinos; Lange, Rüdiger; Bleiziffer, Sabine TI - Impact of a Two-Filter Cerebral Embolic Protection Device on the Complexity and Risk of Transcatheter Aortic Valve Replacement SN - 0171-6425 SN - 1439-1902 PY - 2019 JO - Thorac Cardiovasc Surg JF - The Thoracic and Cardiovascular Surgeon LA - EN VL - 68 IS - 07 SP - 616 EP - 622 DA - 2019/05/15 KW - brain KW - heart valve KW - percutaneous (TAVI) KW - endovascular procedures KW - outcomes KW - surgery KW - complications AB - 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. PB - Georg Thieme Verlag KG DO - 10.1055/s-0039-1688483 UR - http://www.thieme-connect.com/products/ejournals/abstract/10.1055/s-0039-1688483 ER -