Short-term Clinical Follow-up of the Vascular Closure Device MANTATM in Minimally Invasive Cardiac Surgery

Centre Hospitalier Universitaire Dijon204 enrolled

Overview

The percutaneous MANTA Vascular Closure Device is dedicated to the closure of large bore arteriotomies. It appears to be a safe and doable option for vascular access closure in patients undergoing transfemoral Transcatheter Aortic Valve Implantation. Data concerning safety and efficacy of MANTA Vascular Closure Device in Minimally Invasive Cardiac Surgery are scarce. This study aim to assess this novel collagen-based technology in minimal invasive aortic valve replacement surgery.

Study Type

OBSERVATIONAL

Enrollment

204

Conditions

Femoral Artery Injury Aortic Valve Insufficiency

Interventions

Data collectOTHER

Data collect following a vascular closure by MANTA

Eligibility

Medical Language ↔ Plain English

Inclusion Criteria: * Subject voluntarily agreeing to participate in the study * Subject \>= 18 years of age * Patients operated between december 16, 2019 and june 30, 2021 from minimally invasive cardiac surgery with femoral cannulation for cardiopulmonary bypass in Dijon University Hospital * Patients in whom the MANTA device has been used for femoral artery closure Exclusion Criteria: Not applicable

Outcomes

Primary Outcomes

Occurence of major access site vascular complications

according to the Valve Academic Research Consortium (VARC)-2 and Bleeding Academic Research Consortium (BARC)-2 definition criteria in postoperative period

Time frame: 30 days

Hemostasis success

Hemostasis at the puncture site of cutting the MANTA suture without need for manual or mechanical compression and without late re-bleeding

Time frame: 10 min