Early Experience With Embolic Protection Devices During Transcatheter Aortic Valve Replacement.

Objectives: Embolic protection devices (EPDs) have been employed to combat the risk of cerebrovascular events during transcatheter aortic valve replacement (TAVR). The use of EPD has been shown in some studies to decrease periprocedural stroke incidence when compared with non-EPD TAVR. Our study aimed to compare the postoperative outcomes of TAVR with versus without EPD.
Methods: Thirty-three patients who underwent TAVR with EPD at our institution between October 2018 and February 2019 were compared with a contemporaneous control group of 50 patients who underwent TAVR during the same time period without EPD. Baseline characteristics, operative characteristics, and postoperative outcomes were compared between groups. Exclusion criteria for utilization of EPD included arch vessel tortuosity, calcified arch branches, and size discrepancy between the device and host arteries.
Results: The non-EPD group had a higher Society of Thoracic Surgeons risk score (6.8% vs 3.3% in the EPD group; P<.01) and more frequently had a prior diagnosis of diabetes mellitus (52% vs 21% in EPD patients; P<.01). Intraoperative characteristics were comparable, without significant differences in access site used, valve type (Sapien 3 vs Evolut), utilization of rapid pacing, or utilization of balloon aortic valvuloplasty.
Conclusion: EPD was used in lower-risk patients, possibly related to lower incidence of vessel calcification in those patients that may preclude EPD use. Although postoperative outcomes between groups were comparable, current EPD design use precludes its utilization in higher-risk patients.