Aortic Valve Insufficiency, Femoral Artery Injury
Conditions
Brief summary
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.
Interventions
OTHERData collect
Data collect following a vascular closure by MANTA
Sponsors
Centre Hospitalier Universitaire Dijon
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurence of major access site vascular complications | 30 days | according to the Valve Academic Research Consortium (VARC)-2 and Bleeding Academic Research Consortium (BARC)-2 definition criteria in postoperative period |
| Hemostasis success | 10 min | Hemostasis at the puncture site of cutting the MANTA suture without need for manual or mechanical compression and without late re-bleeding |
Countries
France
Outcome results
None listed