Background:

Despite transcatheter aortic valve implantation (TAVI) has rapidly evolved into standard of care for the treatment of elderly moderate- or high-risk patients, vascular access site complications due to the 14 to 18 French delivery systems are still a matter of concern. Subgroup analyses of the early trials, e.g., PARTNER B, as well as several registries showed an increased morbidity and mortality in patients facing major complications compared to those without up to 1 year after TAVI. Aim of our current study was to investigate the impact of major access site complications for long-term outcomes beyond 2 years after TAVI. Moreover, we describe management strategies including conservative, interventional and surgical approaches.

Methods:

We performed a prospective single-centre registry study including all patients that were treated by transfemoral (tf-) TAVI at the University Hospital Jena between August 2016 and December 2019 and willing to participate in the Jenaer Aortenklappenregister (JAKR). Besides a wide range of clinical, laboratory, functional and imaging parameters, bleedings and major vascular complications, e.g., vessel stenosis / occlusion, aneurysms, AV-shunts or dissections, were recorded. Short-term (30 days) as well as 2-year- and long-term- (beyond 2 years) mortality were recorded and compared between patients with or without the occurrence of vascular complications (VCs). Moreover, therapeutic management strategies were described.

Results:

Over the study period, out of 445 moderate- to high-risk patients that underwent tf-TAVI, 44 (9.9%) experienced major VCs. The majority of VCs were bleeding complications (56.8%; 96% of those required transfusion), aneurysms (32%) and stenosis / occlusion (9.1%). Dissections (4.5%) and AV-shunts (2.3%) could only rarely be detected. The mean age of the patients was 78.7 ± 7.3 years, 52% were female and the mean STS score was 5 ± 3.9%. In the entire collective, short-term (30 days) mortality rate was 3.6% and 2-year mortality was 22.6%. When comparing patients with and without VCs, Kaplan-Meier estimates revealed the following survival data: short-term mortality was 15.9% for patients with versus 2.3% for those without VCs (p<0.001); two-year- as well as long-term mortality were also significantly different between the groups: 21.1% after 2 years / 23.4% in long-term follow-up (1776 days at maximum) for patients without VCs vs. 32.6% after 2 years / 43.2% in long-term follow-up for patients with VCs (p=0.038 for 2 years; p=0.004 for long-term follow-up). The majority of VCs could be effectively treated by conservative or interventional approaches, surgery was needed in exceptional cases only.

Conclusions:

Patients undergoing tf-TAVI with vascular access site complications had significantly higher periprocedural / short-term as well as long-term (2 years and beyond) mortality rates compared to those patients without. In this typical real-world TAVI collective, the most frequently occurring vascular complications are similar to those reported in the literature. In general, interventional treatment shows good effectiveness and safety in elderly moderate- to high-risk AS patients.