title: Two-year outcomes after transcatheter or surgical aortic-valve replacement.
abstract: BACKGROUND
  The Placement of Aortic Transcatheter Valves (PARTNER) trial showed that among high-risk patients with aortic stenosis, the 1-year survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical replacement. However, longer-term follow-up is necessary to determine whether TAVR has prolonged benefits.
  
  
  METHODS
  At 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either surgical aortic-valve replacement or TAVR. All patients were followed for at least 2 years, with assessment of clinical outcomes and echocardiographic evaluation.
  
  
  RESULTS
  The rates of death from any cause were similar in the TAVR and surgery groups (hazard ratio with TAVR, 0.90; 95% confidence interval [CI], 0.71 to 1.15; P=0.41) and at 2 years (Kaplan-Meier analysis) were 33.9% in the TAVR group and 35.0% in the surgery group (P=0.78). The frequency of all strokes during follow-up did not differ significantly between the two groups (hazard ratio, 1.22; 95% CI, 0.67 to 2.23; P=0.52). At 30 days, strokes were more frequent with TAVR than with surgical replacement (4.6% vs. 2.4%, P=0.12); subsequently, there were 8 additional strokes in the TAVR group and 12 in the surgery group. Improvement in valve areas was similar with TAVR and surgical replacement and was maintained for 2 years. Paravalvular regurgitation was more frequent after TAVR (P<0.001), and even mild paravalvular regurgitation was associated with increased late mortality (P<0.001).
  
  
  CONCLUSIONS
  A 2-year follow-up of patients in the PARTNER trial supports TAVR as an alternative to surgery in high-risk patients. The two treatments were similar with respect to mortality, reduction in symptoms, and improved valve hemodynamics, but paravalvular regurgitation was more frequent after TAVR and was associated with increased late mortality. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.).
authors.affiliation: Columbia University Medical Center and New York Presbyterian Hospital, New York, NY 10032, USA. sk2427@columbia.edu
authors.forename: Susheel K
authors.initials: SK
authors.lastname: Kodali
authors.forename: Mathew R
authors.initials: MR
authors.lastname: Williams
authors.forename: Craig R
authors.initials: CR
authors.lastname: Smith
authors.forename: Lars G
authors.initials: LG
authors.lastname: Svensson
authors.forename: John G
authors.initials: JG
authors.lastname: Webb
authors.forename: Raj R
authors.initials: RR
authors.lastname: Makkar
authors.forename: Gregory P
authors.initials: GP
authors.lastname: Fontana
authors.forename: Todd M
authors.initials: TM
authors.lastname: Dewey
authors.forename: Vinod H
authors.initials: VH
authors.lastname: Thourani
authors.forename: Augusto D
authors.initials: AD
authors.lastname: Pichard
authors.forename: Michael
authors.initials: M
authors.lastname: Fischbein
authors.forename: Wilson Y
authors.initials: WY
authors.lastname: Szeto
authors.forename: Scott
authors.initials: S
authors.lastname: Lim
authors.forename: Kevin L
authors.initials: KL
authors.lastname: Greason
authors.forename: Paul S
authors.initials: PS
authors.lastname: Teirstein
authors.forename: S Chris
authors.initials: SC
authors.lastname: Malaisrie
authors.forename: Pamela S
authors.initials: PS
authors.lastname: Douglas
authors.forename: Rebecca T
authors.initials: RT
authors.lastname: Hahn
authors.forename: Brian
authors.initials: B
authors.lastname: Whisenant
authors.forename: Alan
authors.initials: A
authors.lastname: Zajarias
authors.forename: Duolao
authors.initials: D
authors.lastname: Wang
authors.forename: Jodi J
authors.initials: JJ
authors.lastname: Akin
authors.forename: William N
authors.initials: WN
authors.lastname: Anderson
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
mesh_terms: D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000601:surgery*; D001022:Aortic Valve Insufficiency / Q000145:classification / Q000209:etiology; D001024:Aortic Valve Stenosis / Q000150:complications / Q000401:mortality / Q000601:surgery* / Q000628:therapy; D006328:Cardiac Catheterization / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000379:methods*; D006470:Hemorrhage / Q000209:etiology; D006493:Heparin / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D011183:Postoperative Complications; D011475:Prosthesis Failure; D020521:Stroke / Q000209:etiology; D015996:Survival Rate; D016896:Treatment Outcome; D014463:Ultrasonography
chemical_list: D000925:Anticoagulants; D010975:Platelet Aggregation Inhibitors; D006493:Heparin