Sutureless Versus Sutured Bioprosthesis: A Prospective Randomized Evaluation Of Surgical Times
Gabriele Di Giammarco, MD, Daniele Marinelli, MD, Michele Di Mauro, MD, Massimiliano Foschi, MD, Aziz Omar, MD.
Department of Cardiac Surgery, University “G.D’Annunzio” Chieti-Pescara, Chieti, Italy.
OBJECTIVE: The introduction of sutureless valve represents one of the most important innovation in cardiac surgery.Many retrospective studies demonstrated that the use of these prosthesis reduce the cardiopulmonary bypass(CPB) and cross-clamp(X-clamp) times.To date, there are no randomized studies analyzing these aspects. Our aim is to evaluate if the use of sutureless prosthesis reduces CPB and X-clamp time during isolated aortic valve replacement(AVR)
METHODS: The primary endpoints were CPB and X-clamp times. Secondary end-points were ICU stay, mortality, ward length of stay, intubation time, rate of PMK implantation.The inclusion criteria were:Patients submitted to AVR for predominant aortic valve stenosis with anatomical characteristics suitable for both Sutured prosthesis and sutureless valve implantation(STJ/annulus diameter ratio≤1.3),single surgeon as a first operator.The power of the study was calculated based on retrospective data.For the primary end-points of CPB and X-Clamp time with a type I alpha error of .01 type II beta error of .02 and a power of the study of 80% the sample size was of 12 patients for each arms of the study.The patients were randomized intraoperatively before X-clamp of the aorta.Data are reported as mean and standard deviation (SD) or median and 25th-75th percentile based on normality test analysis(D’Agostino-Pearson test).The results were analyzed using intention to treat analysis. The diagram of the study is showed in figure 1-A.
RESULTS: There are no differences in patient characteristics.The duration of CPB was 53,83±6.14 minutes and 69,75±15,6(p=.0028)while duration of X-clamp was 37,17±5,18 and 50,58±11,6(p=.0014)respectively for Sutureless and Sutured valve group.Analyzing the detail of the surgical procedure the only significantly shorter time in Perceval group is valve implant time(13,17±2,79 vs 24,42±8,7;p=.0003)(Fig.1-B).For secondary end-point there are no differences.
CONCLUSIONS: We confirm that the use of Sutureless bioprosthesis reduces the CPB time and X-clamp times,mainly related to a reduction in prosthesis implantation time.Multiple centre trial is ongoing and will provide more information about clinical outcome.
LEGENDFig.1A-B.Study flow chart, cardiopulmonary bypass and aortic cross-clamp time and procedural details(AVR:aortic valve replacement;STJ:sino-tubular junction;CPB:cardiopulmonary bypass;X-clamp:Aortic cross-clamp).
Back to 2017 Posters