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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sutures with hand-tied knots | Minimally-invasive isolated aortic valve replacement with Sutures were secured with hand-tied knots | ||
| Sutures with automated fastener device (Cor-Knot) | Minimally-invasive isolated aortic valve replacement with Sutures were secured with automated fastener device (Cor-Knot) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cor Knot | Device | Heart valve replacement with or without the use of automated fastener device Cor Knot |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac surgery times | Aortic cross-clamping and cardiopulmonary bypass times | peroperative data |
| Measure | Description | Time Frame |
|---|---|---|
| Morbimortality | Morbidity (Stroke, pacemaker implantation, aortic regurgitation) Death Valve-related reoperation | Perioperative (30 days) and 24 months follow up |
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Inclusion Criteria:
Exclusion Criteria:
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Patient operated on an Isolated aortic valve replacement with stented prosthesis by Minimally-invasive approach (right anterior minithoracotomy)
Trial on medical records only. No specific regulatory authorization required. The trial has already been recorded as Professionnal evaluation practices.
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| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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