Percutaneous Plug-based Femoral Arteriotomy Closure Device Use in Surgery for Acute Type A Aortic Disection

Karolinska University Hospital

Status

Completed

Conditions

Aortic Dissection

Treatments

Procedure: Percutaneous arteriotomy closed using a plug-based arteriotomy closure device

Procedure: Surgical cut-down and arterial puncture under direct vision

Study type

Observational

Funder types

Other

Identifiers

NCT05482555

MANTA-ATAAD

Details and patient eligibility

About

A single-center prospective study. Patients undergoing surgery for acute type A aortic dissection with femoral arterial cannulation between 2017 and 2022 at the Karolinska University Hospital in Stockholm, Sweden are eligible. Femoral cannulation was performed either with surgical cut-down and arterial puncture under direct vision or percutaneously with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device (MANTA, Essential Medical Inc., Malvern, Pennsylvania). Data regarding preoperative clinical characteristics and operative details were obtained by medical records review.

Enrollment

171 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Operated for acute type A aortic dissection between 2017 and 2022 at the Karolinska University Hospital in Stockholm, Sweden.

Exclusion criteria

Non-femoral arterial cannulation
Concomitant femoro-femoral bypass
Conversion to ECMO with arterial inflow in the previously cannulated femoral artery
Death within 30 days from procedure
Loss to follow-up