Vascular Complications in the Sapien 3 Era: Continued Role of Transapical Approach to Transcatheter Aortic Valve Replacement

Abstract

With the introduction of the latest generation Sapien 3 (S3) transcatheter aortic valve, there has been a reduction in the usage of transapical (TA) approach for transcatheter aortic valve replacements in many centers. However, despite the smaller sheath size and the more streamlined delivery system, vascular complications continue to occur, especially in patients with peripheral vascular disease. Thus, our institution has maintained a stringent TA protocol aiming to prevent these complications. We hypothesize that this protocol has helped to reduce vascular complications and improve outcomes at our institution even in the S3 era. All transcatheter aortic valve replacement procedures done at our institution were considered for analysis. Patients were grouped according to whether their procedure was done before (Pre-S3 era) or after (S3 era) the introduction of the S3 valve, as well as whether they underwent a TA or a transfemoral (TF) approach. A femoral artery intraluminal diameter of <7.5 mm in the Pre-S3 era and <5.5 mm in the S3 era with circumferential calcifications triggered TA approach consideration. Vascular complications included vascular perforation, dissection, flow-limiting stenosis, unplanned vascular surgery, significant postprocedural bleeding, hematoma at the access site, and retroperitoneal bleed. The Welch t test of unequal variance and chi-squared test were used as appropriate. An alpha of <0.05 was considered significant. A total of 275 patients were included in the analysis (121 Pre-S3 era and 154 S3 era). The TA approach was utilized in 45% in the Pre-S3 era vs 15% in the S3 era (P < 0.001). Within the S3 era, 131 underwent the TF approach compared with 23 who underwent the TA approach. TA and TF patients were similar in all preoperative characteristics except hypertension. Mortality was significantly lower in the S3 era (0% vs 4% in the pre-S3 era, P = 0.02). Overall rates of vascular complications were similar between the Pre-S3 and the S3 eras (16% vs 14%, P = 0.63). Overall adverse outcomes were similar between the TA and the TF groups. TA patients saw significantly longer intensive care unit stay and total hospital stay. Our results show that despite a smaller sheath size, vascular complications continue at a similar rate into the S3 era. This occurred in the setting of an ongoing aggressive TA utilization in select patients, specifically those with peripheral vascular disease. Maintaining this approach is likely a large contributor to both our current success and reduced mortality.

Keywords: aortic stenosis; cardiac surgery; interventional cardiology; minimally invasive; outcomes; transcatheter aortic valve replacement.