MANTA vascular closure device bleeding and vascular complications in association with cardiovascular risk factors: a large single centre experience
Authors: Almajed M R , Mahmood S , Obri M , Gonzalez P E , Wang D D , Lee J , Frisoli T , Basir M , Alaswad K , O Neill B , O Neill W , Villablanca P 
Published: November 2023

Abstract

Background
Percutaneous cardiovascular interventions such as transcatheter aortic valve replacement (TAVR), balloon aortic valvuloplasty (BAV), and mechanical circulatory support (MCS) involve large-bore arterial cannulation. Clinically significant bleeding and vascular complications are frequently encountered as a consequence of arterial cannulation. Collagen-based vascular closure devices (VCD) such as MANTA VCD are increasingly utilized to achieve arterial vascular access closure. This study aims to explore the association between cardiovascular risk factors and bleeding and vascular complications in procedures utilizing MANTA VCD.

Methods
A large single-centre retrospective study was performed of patients who underwent TAVR, BAV, and MCS in which arterial access closure was achieved with MANTA VCD. All cases from June 2019 to September 2020 were included. The primary efficacy outcome was defined as immediate haemostasis. The secondary safety outcome was defined as Valve Academic Research Consortium-3 (VARC-3) criteria bleeding and vascular complications. Baseline patient characteristics were obtained to evaluate the association between cardiovascular risk factors and outcomes.

Results
One hundred and seventy-four cases involved vascular access site closure using MANTA VCD. Immediate haemostasis of the access site was achieved in 92.5% of cases (n=161) whereas 7.5% of cases had failed immediate haemostasis (n=13). VARC-3 criteria bleeding and vascular complications occurred in 12.1% of cases (n=21).
Cardiovascular risk factors including coronary artery disease and smoking history were associated with an increased risk for bleeding and vascular complications. Rate of bleeding and vascular complications among patients with coronary artery disease (CAD) (n=71) was 18.3% whereas the rate among patients without CAD (n=103) was 7.8%; this association was statistically significant with an odds ratio of 2.66 (95% CI 1.04 – 6.81, p &lt; 0.05). Rate of bleeding and vascular complications among patients with a smoking history (n=67) was 19.4% whereas the rate among patients without a smoking history (n=107) was 7.5%; this association was statistically significant with an odds ratio of 2.98 (95% CI 1.16 – 7.63, p &lt; 0.05).
There was no statistically significant difference in the rate of bleeding and vascular complications for other cardiovascular risk factors such as, hypertension, peripheral vascular disease, atrial fibrillation, obesity, diabetes, chronic kidney disease, or chronic obstructive pulmonary disease.

Conclusions
MANTA VCD is a safe and effective tool for arterial access closure in procedures such as TAVR, BAV, and MCS. CAD and smoking are associated with a higher risk for VARC-3 criteria bleeding and vascular complications. Further multicentre studies are necessary to explore the association of cardiovascular risk factors with vascular access site closure complications and improve outcomes.