Key result
Perceval sutureless bioprosthesis is linked to ~65% fewer major postoperative complications versus Trifecta sutured bioprosthesis.
Why the study?
The Perceval sutureless bioprosthesis was introduced to shorten surgical times and reduce postoperative complications compared with sutured bioprostheses, but early hemodynamic performance and immediate outcomes needed evaluation.
Does the Perceval sutureless bioprosthesis improve early hemodynamic performance and reduce postoperative complications compared to the Trifecta sutured bioprosthesis in patients undergoing aortic valve replacement?
Observational (n=281)
No
Does the Perceval sutureless bioprosthesis improve early hemodynamic performance and reduce postoperative complications compared to the Trifecta sutured bioprosthesis in patients undergoing aortic valve replacement?
Absolute Event Rate: 6.6% vs 18.6%
p-value: p=0.01
The Perceval sutureless bioprosthesis reduces surgical times and postoperative complications while providing similar early hemodynamic performance compared to the Trifecta sutured bioprosthesis.
May be associated with fewer complications after AVR; leaves open need for RCTs to confirm benefits versus sutured valves.
Introduction: The Perceval sutureless biological prosthesis for aortic valve replacement has been introduced with the rationale for shortening surgical, extracorporeal circulation and aortic cross-clamping times, in order to reduce postoperative complications.Aim: To evaluate early hemodynamic performance and immediate outcomes of implantation of the Perceval sutureless bioprosthesis in comparison with the St. Jude Trifecta sutured bioprosthesis for aortic valve replacement (Perfecta study).Material and methods: Between December 2014 and June 2023, 281 patients underwent St. Jude Trifecta implantation (n = 220, mean age: 75.2 ±6.5 years) and Perceval implantation, when indicated (n = 61, mean age: 77.9 ±5.1 years).Concomitant CABG was performed in 73 (33%) and in 27 (44%) patients, respectively.Results: Extracorporeal circulation and cross-clamp times were significantly shorter in Perceval patients in all aortic valve replacements (61 ±23 and 49 ±18 minutes vs. 96 ±36 and 67 ±21 minutes), and in isolated procedures (54 ±10 and 43 ±8 minutes vs. 84 ±28 and 66 ±21 minutes) (p < 0.0001, for all comparisons).Operative mortality was absent and 2.7%, respectively (p = 0.2).Postoperatively, low output cardiac syndrome (0% vs. 4.5%) and total rate of major cardiac and non-cardiac related complications (6.6% vs. 18.6%) were significantly lower in Perceval patients (p = 0.01).Echocardiography at discharge in comparison with preoperatively showed a relevant and similar decrease of mean and peak trans-aortic valve gradients for the Trifecta prosthesis (11.6 ±4.3 vs. 50 ±15.2mm Hg; 21.6 ±7.3 vs. 78.8±24 mm Hg) and for the Perceval prosthesis (12.6 ±4.8 vs. 52 ±12.5 mm Hg; 22.6 ±7.9 vs. 77.8±16 mm Hg) (p < 0.00001, for all comparisons).Better global cardiac function was observed in Perceval patients.Concomitant multi-vessel and left main coronary artery disease (p = 0.046; HR = 4.6) and chronic pulmonary disease (p = 0.006; HR = 5.6) were detected as independent predictors of death and postoperative major complications.Conclusions: Early hemodynamic performance appears to be satisfactory with the use of Trifecta sutured and Perceval sutureless bioprostheses.Perceval implantation allows reduction of surgical times, better preservation of myocardial contractile function and, consequently, reduction of the risk of postoperative complications.
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Nardi et al. (2024) conducted an observational in Severe aortic valve disease (n=281). Perceval sutureless bioprosthesis vs. St. Jude Trifecta sutured bioprosthesis was evaluated on Total major cardiac and non-cardiac postoperative complications (including deaths) (p=0.01). The Perceval sutureless bioprosthesis significantly reduced the total rate of major postoperative complications to 6.6% compared to 18.6% with the Trifecta sutured bioprosthesis.
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