Introduction: Percutaneous femoral access is the preferred access route for transcatheter aortic valve replacement (TAVR). The majority of experienced TAVR centers use two 6F Perclose ProGlide™ devices to close the primary vascular access site, deployed prior to upsizing sheath size with closure completed at the end of the case (the "preclose" approach). A strategy of utilizing a single Perclose device to preclose may have advantages including fewer complications, complexity, and cost, but the safety of this is unknown. This study examines in the safety and efficacy of using a single Perclose versus double Perclose for perclosure of large bore access during TAVR. Methods: Patients undergoing Transfemoral (TF) TAVR from January 2014 to December 2017 within the Cleveland Clinic Aortic Valve Center were identified. A retrospective review of medical charts was conducted. Vascular complications were defined according to the VARC-2 criteria. Results: A total of 740 patients were included; 487 (65.8%) received a single Perclose device while 253 (34.2%) received double Perclose devices. Baseline characteristics were similar with no differences between the single versus double Perclose groups, respectively. The access sheath size was similar in both groups with (14, 16, and 18 F) being the most common sizes utilized. Of the total 487 patients with single Perclose, 75.6% needed additional closure device (AngioSeal). With double Perclose strategy, additional closure device (AngioSeal) was used in 40.3% patients with 470 (63.5%) patients being successfully perclosed. Vascular complication rates including hematoma, stenosis requiring stenting, pseudoaneurysm, and other major vascular complications were similar between both groups.
Background: Transcatheter aortic valves are prone to acute recoil similar to the metal-based coronary stents. However, it is not clear if recoil remains a factor only after the initial valve deployment or also after post-dilation. Methods: We conducted a retrospective observational study of patients who underwent transfemoral transcatheter aortic valve replacement (TAVR) with SAPIEN-3 valve. Acute recoil at the upper, central, and lower levels of the valve was calculated in both anteroposterior right anterior oblique (RAO) and lateral left anterior oblique (LAO) views after initial deployment as well as after post-dilation. The average recoil of the RAO and LAO views was also calculated and described as RAO/LAO. Results: The acute recoil in the RAO/LAO views (mean ± SD) was 3.9 ± 1.1% after valve deployment in the whole study population (n = 257). Among the subset of patients who required post-dilation (n = 133), the mean acute recoil in the RAO/LAO views was found to be greater after initial valve deployment as compared with after post-dilation (3.8 ± 1.1% vs. 3.0 ± 0.9%; p < .001). Further, acute recoil was significantly greater in the RAO view than the LAO view and at the central level of the prosthesis as compared with the upper and lower levels. Those findings were consistent after initial deployment as well as after post-dilation. Clinical outcomes were similar between patients who required post-dilation compared to those who did not. In multivariable logistic regression analysis, only smaller valve cover index was found to be an independent predictor of 30-day mild or greater aortic regurgitation (OR 0.007; 95% CI 0.0001-0.707; p = .035). Conclusion: Acute elastic recoil of the SAPIEN-3 valve was significantly less after post-dilation as compared with after deployment. It was also greater when measured in the RAO view as compared with the LAO view. Furthermore, acute recoil was not homogenous across the height of the valve stent frame.
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