title: A comprehensive review of the PARTNER trial.
abstract: OBJECTIVE
  Percutaneous transcatheter aortic valve replacement was introduced in 2002, but its effectiveness remained to be assessed.
  
  
  METHODS
  A prospective, randomized trial (the Placement of Aortic Transcatheter Valves, or PARTNER) was designed with 2 arms: PARTNER A (n = 699) for high-risk surgical patients (Society of Thoracic Surgeons score >10%, surgeon assessed risk of mortality >15%) and PARTNER B (n = 358, patients inoperable by assessment of 2 surgeons). PARTNER A patients were divided into femoral artery access transcatheter aortic valve replacement or none (n = 207), and then randomized to open aortic valve replacement (n = 351) or device (n = 348). Inclusion criteria included valve area <0.8 cm(2), gradient >40 mm Hg or peak >64 mm Hg, and survival >1 year. The end point of the study was 1-year mortality.
  
  
  RESULTS
  Thirty-day mortality for PARTNER A was 3.4% for transcatheter aortic valve replacement and 6.5% for aortic valve replacement; 1-year mortality was 24.2% and 26.8%, respectively (P = .001 for noninferiority). The respective prevalence of stroke was 3.8% and 2.1% (P = .2), although for all neurologic events, the difference between transcatheter aortic valve replacement and aortic valve replacement was significant (P = .04), including 4.6% for femoral artery access transcatheter aortic valve replacement versus 1.4% for open aortic valve replacement (P = .05). For PARTNER B--transcatheter aortic valve replacement versus medical treatment-30-day mortality was 5.0% versus 2.8% (P = .41), and at 1 year, mortality was 30.7% versus 50.7% (P < .001), respectively. Hospitalization cost of transcatheter aortic valve replacement for PARTNER B was $78,542, or $50,200 per year of life gained. Analysis of PARTNER A strokes showed that hazard with transcatheter aortic valve replacement peaked early, but thereafter remained constant in relation to aortic valve replacement. Two-year PARTNER A data showed paravalvular regurgitation was associated with increased mortality, even when mild (P < .001). Continued access to transapical transcatheter aortic valve replacement (n = 853) showed a mortality of 8.2% and decline in strokes to 2.0%. Of the 1801 Cleveland Clinic patients reviewed to December 2010, 214 (12%) underwent transcatheter aortic valve replacement with a mortality of 1%; in 2011, 105 underwent transcatheter aortic valve replacement: 34 transapical aortic valve replacement, with no deaths, and 71 femoral artery access aortic valve replacement with 1 death.
  
  
  CONCLUSIONS
  The PARTNER A and B trials showed that survival has been remarkably good, but stroke and perivalvular leakage require further device development.
authors: Department of Thoracic and Cardiovascular Surgery, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio, USA. svenssl@ccf.org
authors: Lars G
authors: LG
authors: Svensson
authors: Murat
authors: M
authors: Tuzcu
authors: Samir
authors: S
authors: Kapadia
authors: Eugene H
authors: EH
authors: Blackstone
authors: Eric E
authors: EE
authors: Roselli
authors: A Marc
authors: AM
authors: Gillinov
authors: Joseph F
authors: JF
authors: Sabik
authors: Bruce W
authors: BW
authors: Lytle
mesh_terms: D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000191:economics / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000191:economics / Q000295:instrumentation / Q000401:mortality; D005263:Femoral Artery; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000191:economics / Q000295:instrumentation / Q000379:methods* / Q000401:mortality; D017721:Hospital Costs; D006801:Humans; D015337:Multicenter Studies as Topic; D011446:Prospective Studies; D011475:Prosthesis Failure; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors; D020521:Stroke / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome