Vascular complications following TAVI: safety and predictors of the MANTA vascular closure device

Introduction Vascular complications are common and clinically significant adverse events after transcatheter aortic valve implantation (TAVI), with reported incidence rates ranging between 5% and 20%. Recent advancements, including the MANTA vascular closure device (MANTA-VCD), have been introduced to mitigate these risks. Purpose To assess vascular complications associated with main arterial access after TAVI, focusing on the performance of the MANTA-VCD system. Methods We performed a retrospective, single-centre analysis of patients who underwent TAVI between March 2020 and September 2023. Patients who did not undergo main arterial access closure using the MANTA-VCD system were excluded. Baseline patient characteristics were evaluated, and the primary outcome measured was the incidence of vascular complications. Potential predictors were examined using binary logistic regression analysis. Results In our cohort of 628 patients, the MANTA-VCD system was utilized for arterial access closure in 604 cases (96.1%). The mean age was 81.6 ± 6.0 years, with a balanced gender distribution. Cardiovascular risk factors were prevalent, including arterial hypertension in 83.4% of patients and dyslipidemia in 70.7%. The right common femoral artery was the most frequently accessed site (71.9%). Vascular complications occurred in 35 patients (5.8%), with localized hematomas or bleeding requiring transfusion being the most common events. Among these, 65.7% were female, 88.6% had arterial hypertension, and 80.0% had dyslipidaemia. While the right common femoral artery was the most frequently affected site (60%), the left common femoral artery demonstrated a statistically significant higher prevalence of complications (p=0.001). Additionally, dialysis-dependent patients represented 5.7% of those experiencing complications. Binary logistic regression identified female gender (OR 2.49; CI 1.18-5.29; p=0.017), dialytic treatment (OR 9.74; CI 1.56-60.83, p=0.015) and left common femoral artery access (OR 5.47, CI 1.69-17.7, p=0.005) as potential predictors of vascular complications. Conclusion The MANTA-VCD system demonstrated a low vascular complication rate (5.8%) when used for main arterial access closure in TAVI, consistent with previous findings and reinforcing its safety and efficacy. Predictors of vascular complications included female sex, dialysis, and less commonly used primary access sites, emphasizing the need for targeted assessment in these high-risk subgroups.