Incidence, Prognosis and Predictors of Major Vascular Complications and Percutaneous Closure Device Failure Following Contemporary Percutaneous Transfemoral Transcatheter Aortic Valve Replacement

Abstract

Objectives: To determine the incidence, prognosis, and predictors of major Valve Academic Research Consortium (VARC-2) vascular complications (VCs) and percutaneous vascular closure device failure (PCDF) following contemporary percutaneous transfemoral transcatheter aortic valve replacement (TF-TAVR).

Background: Limited data exists on the incidence and predictors of VCs and PCDFs following percutaneous TF-TAVR using contemporary 14-16 French (F) sheaths.

Methods: We recorded clinical and procedural characteristics, computer tomography (CT) angiographic data, 30-day VCs, mortality, and length of stay (LOS) in all consecutive percutaneous TF-TAVRs at a single center from June 2016 to October 2018. CT measures included common femoral artery (CFA) and external iliac artery (EIA) diameters, sheath to CFA and EIA ratios (SFAR and SEIAR), depth of CFA, extent and location of CFA calcification and pelvic vessel tortuosity (2 bends ≥90°). Multivariable regression was used to predict major VCs and percutaneous closure device failure (PCDF), respectively.

Results: The final sample consisted of 303 percutaneous TF-TAVRs. Median age was 80 years, 51% were male, 86% Caucasian, 33% had diabetes mellitus (DM) and mean STS score was 5.8 ± 3.8%. Baseline characteristics were similar in patients with vs. without VCs, other than coronary artery disease (CAD) (69% vs. 54%, respectively; p = 0.029) and DM (21% vs. 36%, respectively; p = 0.02). There were 65 (21%) vascular complications: 19 major VCs [6.3%], 29 minor [VCs 9.6%] and 17 PCDFs [5.6%]. Overall, 30-day mortality was low (2.6%). Major VCs were associated with higher mortality (42% vs. 0%, p < 0.0001) while minor VCs (3% vs. 0%, mortality p = 0.99) and PCDFs (3% vs. 0% mortality, p = 0.99) were not. PCDFs were associated with a longer median LOS (4 vs. 3 days, p = 0.02). The independent predictors of major VCs were pelvic vessel tortuosity (OR 3.1; 95% CI 1.1-9.2) and presence of CAD (OR 8.2; 95% CI 1.8-37). Female gender showed a strong trend toward increased risk (OR 3.4; CI 0.84-14; p = 0.086). There were no independent predictors of PCDF.

Conclusion: Contemporary percutaneous TF-TAVR is associated with a low risk of mortality, major VCs and PCDFs. Major VCs confer increased mortality and PCDFs prolong LOS. Pelvic vessel tortuosity and a history of CAD predict major VCs; there were no predictors of PCDFs. These results provide a contemporary update on the incidence and implications of these important vascular complications in the current era of percutaneous TF-TAVR using 14-16F vascular sheaths.

Keywords: TAVR; Transcatheter aortic valve replacement; Vascular complications.

Fig. 1.

Study flowchart.

Fig. 2.

Computed tomography images of (a) non-contrast axial image of a shallow (28 mm depth) right CFA with anterior calcification, (b) a deep (88 mm) right CFA without calcification, (c) a relatively shallow right CFA with near complete circumferential calcification and (d) a 3-dimensional reconstructed view demonstrating marked tortuosity of the left common iliac artery. The red arrows in the figures indicate the depth (mm) and location of the corresponding CFA.

Fig. 3.

Graph depicting the incidence of VARC-2 vascular complications.

Fig. 4.

Graph depicting 30-day mortality according to various forms of VARC-2 vascular complications.

Fig. 5.

Receiver operator curves using SEIAR > 0.75, SFAR > 0.75 and the multivariable model as predictors of major VARC-2 vascular complications.