018 * CLINICAL AND HAEMODYNAMIC OUTCOMES IN 658 PATIENTS RECEIVING THE PERCEVAL SUTURELESS AORTIC VALVE: EARLY RESULTS FROM A PROSPECTIVE EUROPEAN MULTICENTRE STUDY (CAVALIER TRIAL)

Abstract

Objectives: The aim of the CAVALIER trial was to evaluate the safety and effectiveness of the Perceval sutureless aortic valve in patients undergoing aortic valve replacement (AVR). We report the 30-day clinical and haemodynamic outcomes from the largest study cohort with a sutureless valve. Methods: From February 2010 to September 2013, a total of 658 consecutive patients (mean age 77.8; 64.4% females; mean logistic EuroSCORE 10.2) underwent AVR in 25 European centres. Isolated AVR was performed in 451 (68.5%) patients and out of them, a less invasive approach in 219 (33.3%) cases; 41.1% were octogenarians. Results: Implantation was successful in 628 patients (95.4%). In isolated AVR through sternotomy, mean cross-clamp and cardiopulmonary bypass (CPB) time were 32.6 and 53.7 min, but 38.7 and 64.4 min with less invasive approach. Preoperative mean and peak pressure gradients decreased from 44.8 and 73.24 mmHg, respectively, to 10.16 and 19.14 mmHg at discharge. Mean effective ori[fi]ce area (EOA) improved from 0.72 to 1.46 cm2.Table 1: Postoperative complications Total (628 patients) Isolated AVR (431 patients) Complex AVR (197 patients) All deaths 23 (3.7%) 11 (2.6%) 12 (6.1%) Valve related deaths 2 (0.3%) 1 (0.2%) 1 (0.5%) Overall explants 6 (1.0%) 3 (0.7%) 3 (1.5%) Explant for paravalvular leakages 3 (0.5%) 2 (0.5%) 1 (0.5%) Stroke 13 (2.1%) 10 (2.3%) 3 (1.5%) Endocarditis 1 (0.2%) - 1 (0.5%) Conclusion: The current 30-day results show that the Perceval valve is safe (favourable haemodynamic and low complication rate), and can be implanted quickly with a reproducible technique. Short cross-clamp and CPB times were achieved in both sternotomy and with the less invasive approach. Perceval represents a promising alternative to biological AVR, especially for less invasive approach and including older patients.