Abstract
BackgroundsAmong vascular closure devices (VCDs), the novel collagen plug-based MANTA VCD is the first designed for large bore percutaneous access. We aimed to assess the features and predictors of access-site vascular complications in an unselected trans-femoral transcatheter aortic valve replacement (TF-TAVR) population.MethodsPatients undergoing large bore arteriotomy closure with 18F MANTA VCD following TF-TAVR at a large tertiary care center from September 2019 to January 2021 were prospectively analyzed. Primary Outcome was the MANTA VCD access-site-related complications according to Valve Academic Research Consortium-3 (VARC) definitions. Its incidence and predictors were evaluated.ResultsEighty-eight patients (median age 82 years, 48% male, 3.3 median Society of Thoracic Surgeons score) undergoing TF-TAVR were included, mostly (63%) treated with a self-expandable device and with outer diameter sizes varied from 18F to 24-F. MANTA VCD technical success rate was 98%, while 10 patients (11%) experienced MANTA VCD access-site vascular complications which included 8% of minor complications and only to 2% of major events resulting in VARC type ≥2 bleeding. Vessel occlusion/stenosis (60%), perforation (20%), and pseudoaneurysm/dissection/hematoma (20%) occurred, but all were managed without surgical treatment. Independent predictors of failure were age (p = 0.04), minimum common femoral artery diameter (CFA) (p < 0.01), sheath-to-femoral-artery ratio (SFAR) (p < 0.01), and a lower puncture height (p = 0.03). A CFA diameter <7.1 mm with a SFAR threshold of 1.01 were associated with VCD failure.ConclusionsIn a more comers TF-TAVR population, MANTA VCD was associated with reassuring rates of technical success and major access-site vascular complications. Avoiding lower vessel size and less puncture site distance to CFA bifurcation might further improve outcomes.
Highlights
Catheter-based treatment strategies for complex cardiovascular disease requiring large bore femoral vascular access, such as trans-femoral transcatheter aortic valve replacement (TF-TAVR), markedly increased over the last decades [1]
A total of 88 consecutive patients undergoing TF-TAVR treated with 18F MANTA large bore arteriotomy closure were included in our analysis (Figure 1)
No differences were found in terms of the presence of stenosis of the target ileofemoral artery at the ultrasound assessment, the presence and location of calcification, the puncture height, and the grading of calcification
Summary
Catheter-based treatment strategies for complex cardiovascular disease requiring large bore femoral vascular access, such as trans-femoral transcatheter aortic valve replacement (TF-TAVR), markedly increased over the last decades [1]. Percutaneous large bore arteriotomy closure with the most used suture-based closure devices remained associated with a 5–20% of complication rates [4, 5]. The MANTA VCD (Teleflex Inc., Pennsylvania, USA) is the first commercially available collagen-based technology dedicated for large bore arteriotomy closure approved by the United States Food and Drug Administration (FDA) [6, 7]. A reliable safety and efficacy have been well established in selected TAVR populations, but comparative studies with conventional suture-based devices have provided heterogenous results [8–12]. We sought to evaluate MANTA VCD performance for large bore arteriotomy closure in an unselected singlecenter TF-TAVR population, with a focus on access-site vascular complications rates and predictors
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