title: The sutureless aortic valve at 1 year: A large multicenter cohort study.
abstract: OBJECTIVE
  Sutureless aortic valve replacement (AVR) offers an alternative to standard AVR in aortic stenosis. This prospective, single-arm study aimed to demonstrate safety and effectiveness of a bovine pericardial sutureless aortic valve at 1 year.
  
  
  METHODS
  From February 2010 to September 2013, 658 patients (mean age 78.3 ± 5.6 years; 40.0% octogenarian; 64.4% female; mean Society of Thoracic Surgeons score 7.2 ± 7.4) underwent sutureless AVR in 25 European centers. Concomitant cardiac procedures were performed in 29.5% and minimally invasive cardiac surgery in 33.3%.
  
  
  RESULTS
  One-year site-reported event rates were 8.1% for all-cause mortality, 4.5% for cardiac mortality, 3.0% for stroke, 1.9% for valve-related reoperation, 1.4% for endocarditis, and 0.6% for major paravalvular leak. No valve thrombosis, migration, or structural valve deterioration occurred. New York Heart Association class improved at least 1 level in 77.5% and remained stable (70.4% New York Heart Association class I or II at 1 year). Mean effective orifice area was 1.5 ± 0.4 cm(2); pressure gradient was 9.2 ± 5.0 mm Hg. Left ventricular mass decreased from 138.5 g/m(2) before surgery to 115.3 g/m(2) at 1 year (P < .001). Echocardiographic core laboratory findings confirmed that paravalvular leak was rare and remained stable during follow-up.
  
  
  CONCLUSIONS
  The Perceval sutureless valve resulted in low 1-year event rates in intermediate-risk patients undergoing AVR. New York Heart Association class improved in more than three-quarters of patients and remained stable. These data support the safety and efficacy to 1 year of the Perceval sutureless valve in this intermediate-risk population.
authors.affiliation: Department of Cardiac Surgery, Paracelsus Medical University, Klinikum Nürnberg, Nuremberg, Germany. Electronic address: Theodor.Fischlein@klinikum-nuernberg.de.
authors.forename: Theodor
authors.initials: T
authors.lastname: Fischlein
authors.affiliation: Department of Cardiac Surgery, U.Z. Gasthuisberg, Leuven, Belgium.
authors.forename: Bart
authors.initials: B
authors.lastname: Meuris
authors.affiliation: Department of Thoracic and Cardiovascular Surgery, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.
authors.forename: Kavous
authors.initials: K
authors.lastname: Hakim-Meibodi
authors.affiliation: Klinik fur Herzchirurgie, Herzzentrum Universitaet Leipzig, 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: Department of Cardiac, Vascular and Endovascular Surgery and Transplantology, School of Medicine, Silesian Center for Heart Diseases, Zabrze, Poland.
authors.forename: Marian
authors.initials: M
authors.lastname: Zembala
authors.affiliation: Clinical Affairs Department, Sorin Group Italia Srl, Saluggia, Italy.
authors.forename: Sara
authors.initials: S
authors.lastname: Gaggianesi
authors.affiliation: Hôpital Cardiologique Du Haut-Leveque, Pessac, France.
authors.forename: Francesco
authors.initials: F
authors.lastname: Madonna
authors.affiliation: Cardiac Medico-Surgical Department, Institute Mutualiste Montsouris, Paris, France.
authors.forename: François
authors.initials: F
authors.lastname: Laborde
authors.affiliation: MedStar Cardiovascular Research Network, Washington Hospital Center, Washington, DC.
authors.forename: Federico
authors.initials: F
authors.lastname: Asch
authors.affiliation: Department of Cardiothoracic, Transplantation & Vascular Surgery, Hannover Medical School, Germany.
authors.forename: Axel
authors.initials: A
authors.lastname: Haverich
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000601:surgery*; D001705:Bioprosthesis; D002417:Cattle; D004452:Echocardiography; D005060:Europe / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D008875:Middle Aged; D019060:Minimally Invasive Surgical Procedures / Q000379:methods*; D011183:Postoperative Complications / Q000401:mortality; D011446:Prospective Studies; D011474:Prosthesis Design; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D016896:Treatment Outcome
keywords: aortic valve; aortic valve replacement; bioprosthesis; sutureless