title: Results of the post-market Registry to Evaluate the HeartWare Left Ventricular Assist System (ReVOLVE).
abstract: BACKGROUND
  The post-market Registry to Evaluate the HeartWare Left Ventricular Assist System (ReVOLVE) is an investigator-initiated registry established to collect post-CE Mark Trial clinical data on patients receiving a HeartWare ventricular assist device (HVAD) in the European Union and Australia.
  
  
  METHODS
  The ReVOLVE is a multi-center, prospective, single-arm registry performed at seven centers in Europe and two in Australia. Herein we describe a total of 254 commercial HVAD implants according to labeled indications between February 2009 and November 2012. Summary statistics included patients' demographics, adverse events, length of support and outcomes.
  
  
  RESULTS
  Compared with the clinical trial supporting the CE Mark of the HeartWare system, patient selection differed in that patients were older, and there were higher proportions of females and patients with idiopathic cardiomyopathies in the ReVOLVE cohort. Duration of support ranged from 1 to 1,057 days, with a mean of 363 ± 280 days (median 299.5 days). Transplantation was done in 56 patients (22%), explant for recovery was performed in 3 patients (1%), 43 died while on support (17%), and 152 (60%) remain on the device. Success in patients with the HeartWare system was 87% at 6 months, 85% at 1 year, 79% at 2 years and 73% at 3 years. Adverse event rates were low, comparable or improved when compared to the CE Mark Trial.
  
  
  CONCLUSIONS
  Real-world use of the HeartWare system continues to demonstrate excellent clinical outcomes in patients supported with the device.
authors.affiliation: Department of Cardiothoracic, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany; Clinic for Heart Surgery, Heart Center, Leipzig University, Leipzig, Germany. Electronic address: martin.strueber@med.uni-leipzig.de.
authors.forename: Martin
authors.initials: M
authors.lastname: Strueber
authors.affiliation: Advanced Heart Failure and Cardiac Transplant Service, Royal Perth Hospital, Perth, Western Australia, Australia.
authors.forename: Robert
authors.initials: R
authors.lastname: Larbalestier
authors.affiliation: Heart Lung Transplant Unit, St. Vincent׳s Hospital, Sydney, New South Wales, Australia.
authors.forename: Paul
authors.initials: P
authors.lastname: Jansz
authors.affiliation: Department of Cardiac Surgery, Medical University Vienna, Vienna, Austria.
authors.forename: Daniel
authors.initials: D
authors.lastname: Zimpfer
authors.affiliation: Department for Cardiothoracic Surgery, Oslo University Hospital, Oslo, Norway.
authors.forename: Arnt E
authors.initials: AE
authors.lastname: Fiane
authors.affiliation: Department of Transplantation, Papworth Hospital NHS Foundation Trust, Cambridge, UK.
authors.forename: Steven
authors.initials: S
authors.lastname: Tsui
authors.affiliation: Department of Cardiothoracic Transplantation & Mechanical Support, Royal Brompton & Harefield NHS Trust, Harefield Hospital, Harefield, London, UK.
authors.forename: André
authors.initials: A
authors.lastname: Simon
authors.affiliation: Department of Cardiothoracic, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany.
authors.forename: Jan D
authors.initials: JD
authors.lastname: Schmitto
authors.affiliation: Department of Cardiothoracic Transplantation & Mechanical Support, Royal Brompton & Harefield NHS Trust, Harefield Hospital, Harefield, London, UK.
authors.forename: Asghar
authors.initials: A
authors.lastname: Khaghani
authors.affiliation: Department of Cardiac Surgery, Medical University Vienna, Vienna, Austria.
authors.forename: George M
authors.initials: GM
authors.lastname: Wieselthaler
authors.affiliation: HeartWare, Inc., Framingham, Massachusetts.
authors.forename: Kevin
authors.initials: K
authors.lastname: Najarian
authors.affiliation: Department for Cardiothoracic Surgery, Freeman Hospital, Newcastle upon Tyne, UK.
authors.forename: Stephan
authors.initials: S
authors.lastname: Schueler
mesh_terms: D000328:Adult; D000368:Aged; D001315:Australia; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000601:surgery*; D006353:Heart-Assist Devices; D006801:Humans; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D055815:Young Adult
keywords: HVAD; HeartWare; ReVOLVE Registry; ventricular assist system