Automated Fastener Device Versus Manually Tied Knot in MiAVR

Centre Hospitalier La Chartreuse

Status: Completed

Conditions: Heart Valve Diseases

Treatments: Device: Cor Knot

Study type: Observational

Funder types: Other

Identifiers

NCT03664102

CCVT-MORGANT 082018

Details and patient eligibility

About

The aim of the investigator's study was to evaluate the efficacy and the safety of the Cor-Knot device in isolated aortic valve replacement (AVR) by right anterior minithoracotomy (RAMT).

Four hundred and forty patients were operated for AVR by RAMT. Of these patients, 221 underwent isolated AVR surgery with stented prosthesis. Sutures were secured using the Cor-Knot titanium fastener in 63 patients and knots were hand-tied in 158.

The aortic cross-clamping and cardiopulmonary bypass times were significantly decreased in the AT group compared with the MT group. Clinical outcomes were similar in the two groups, whether in the analysis of non-matched or matched groups. There was no difference in 30 day-mortality and the stroke and TIA rates were comparable The automated Cor-Knot fastener is an easy-to-use, time-saving device which does not increase perioperative morbi-mortality in patients undergoing AVR by right anterior minithoracotomy.

Enrollment: 221 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age > 18 years
• Elective patient
• Isolated aortic valve replacement with stented prosthesis
• Minimally-invasive approach (right anterior minithoracotomy)

Exclusion criteria

• Associated procedure
• Aortic valve replacement with sutureless or rapid valve deployment prosthesis
• Active endocarditis
• Prior cardiac surgery

Trial design

221 participants in 2 patient groups

Sutures with hand-tied knots

Description:

Minimally-invasive isolated aortic valve replacement with Sutures were secured with hand-tied knots

Sutures with automated fastener device (Cor-Knot)

Description:

Minimally-invasive isolated aortic valve replacement with Sutures were secured with automated fastener device (Cor-Knot)

Treatment:

Device: Cor Knot