title: Clinical and haemodynamic outcomes in 658 patients receiving the Perceval sutureless aortic valve: early results from a prospective European multicentre study (the Cavalier Trial)†.
abstract: OBJECTIVE
  The aim of the Cavalier trial was to evaluate the safety and performance 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, 658 consecutive patients (mean age 77.8 years; 64.4% females; mean logistic EuroSCORE 10.2%) underwent AVR in 25 European Centres. Isolated AVRs were performed in 451 (68.5%) patients with a less invasive approach in 219 (33.3%) cases. Of the total, 40.0% were octogenarians. Congenital bicuspid aortic valve was considered an exclusion criterion.
  
  
  RESULTS
  Implantation was successful in 628 patients (95.4%). In isolated AVR through sternotomy, the mean cross-clamp time and the cardiopulmonary bypass (CPB) time were 32.6 and 53.7 min, and with the less invasive approach 38.8 and 64.5 min, respectively. The 30-day overall and valve-related mortality rates were 3.7 and 0.5%, respectively. Valve explants, stroke and endocarditis occurred in 0.6, 2.1 and in 0.1% of cases, respectively. Preoperative mean and peak pressure gradients decreased from 44.8 and 73.24 mmHg to 10.24 and 19.27 mmHg at discharge, respectively. The mean effective orifice area improved from 0.72 to 1.46 cm(2).
  
  
  CONCLUSIONS
  The current 30-day results show that the Perceval valve is safe (favourable haemodynamic effect and low complication rate), and can be implanted with a fast and reproducible technique after a short learning period. Short cross-clamp and CPB times were achieved in both isolated and combined procedures. The Perceval valve represents a promising alternative to biological AVR, especially with a less invasive approach and in older patients.
authors.affiliation: Cardiac Medico-Surgical Department, Institute Mutualiste Montsouris, Paris, France francois.laborde@imm.fr.
authors.forename: François
authors.initials: F
authors.lastname: Laborde
authors.affiliation: Department of Cardiac Surgery, Klinikum Nuernberg, Paracelsus Medical University, Nuremberg, Germany.
authors.forename: Theodor
authors.initials: T
authors.lastname: Fischlein
authors.affiliation: Klinik, Herz- und Diabeteszentrum, Bad Oeynhausen, Germany.
authors.forename: Kavous
authors.initials: K
authors.lastname: Hakim-Meibodi
authors.affiliation: Herzzentrum Universitaet Leipzig, Klinik fur Herzchirurgie, Leipzig, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Misfeld
authors.affiliation: Inselspital, Bern, Switzerland.
authors.forename: Thierry
authors.initials: T
authors.lastname: Carrel
authors.affiliation: Silesian University Center for Heart Disease, Zabrze, Poland.
authors.forename: Marian
authors.initials: M
authors.lastname: Zembala
authors.affiliation: Hospital Cardiologique Du Haut-Leveque, Pessac, France.
authors.forename: Francesco
authors.initials: F
authors.lastname: Madonna
authors.affiliation: Department of Cardiac Surgery, U.Z. Gasthuisberg, Leuven, Belgium.
authors.forename: Bart
authors.initials: B
authors.lastname: Meuris
authors.affiliation: Department of Cardio-thoracic, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany.
authors.forename: Axel
authors.initials: A
authors.lastname: Haverich
authors.affiliation: Department of Cardio-thoracic, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany.
authors.forename: Malakh
authors.initials: M
authors.lastname: Shrestha
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D020878:Device Removal; D005060:Europe; D005260:Female; D006350:Heart Valve Prosthesis / Q000009:adverse effects / Q000706:statistics & numerical data*; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D006439:Hemodynamics; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011474:Prosthesis Design
keywords: Aortic valve replacement; Multicentre study; Sutureless aortic valve prosthesis