title: Bleeding complications after surgical aortic valve replacement compared with transcatheter aortic valve replacement: insights from the PARTNER I Trial (Placement of Aortic Transcatheter Valve).
abstract: OBJECTIVE
  This study sought to identify the incidence, predictors, and prognostic impact of bleeding complications (BC) after surgical aortic valve replacement (SAVR) compared with transcatheter aortic valve replacement (TAVR).
  
  
  BACKGROUND
  Bleeding complications after SAVR and TAVR are frequent and may be associated with an unfavorable prognosis.
  
  
  METHODS
  In the randomized controlled PARTNER (Placement of Aortic Transcatheter Valve) I trial, 657 patients from cohort A (operable high risk) were randomly assigned to SAVR or TAVR (transfemoral [TF] if iliofemoral access was suitable or transapical [TA] if not) and received the designated treatment. First-generation Edwards SAPIEN valves and delivery systems (Edwards Lifesciences, Irvine, California) were used for TAVR, through a 22- or 24-F sheath. The 30-day rates of major BC (modified Valve Academic Research Consortium definitions), predictors of BC, and their association with 1-year mortality were assessed.
  
  
  RESULTS
  A total of 71 (22.7%), 27 (11.3%), and 9 (8.8%) patients had major BC within 30 days of the procedure after SAVR, TF-TAVR, and TA-TAVR, respectively (p < 0.0001). SAVR was associated with a significantly higher 30-day rate of transfusion (17.9%) than either TF-TAVR (7.1%) or TA-TAVR (4.8%; p < 0.0001). Independent predictors of major BC were the occurrence of major vascular complications and use of intraprocedural hemodynamic support among TF-TAVR patients, severe procedural complications requiring conversion to open surgery among TA-TAVR patients, and the presence of low hemoglobin at baseline among SAVR patients. Major BC was identified as the strongest independent predictor of 1-year mortality among the full cohort. However, risk-adjusted analyses demonstrated a significant interaction between BC and treatment strategy with respect to mortality, suggesting that BC after SAVR have a greater impact on prognosis than after TAVR.
  
  
  CONCLUSIONS
  Among high-risk aortic stenosis patients enrolled in the PARTNER I randomized trial, BC were more common after SAVR than after TAVR and were also associated with a worse long-term prognosis. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).
authors.affiliation: Columbia University Medical Center/New York Presbyterian Hospital, New York, New York; Cardiovascular Research Foundation, New York, New York; Hôpital du Sacré-Coeur de Montréal, Montréal, Québec, Canada.
authors.forename: Philippe
authors.initials: P
authors.lastname: Généreux
authors.affiliation: Saint Luke's Mid America Heart Institute, Kansas City, Missouri.
authors.forename: David J
authors.initials: DJ
authors.lastname: Cohen
authors.affiliation: Columbia University Medical Center/New York Presbyterian Hospital, New York, New York.
authors.forename: Mathew R
authors.initials: MR
authors.lastname: Williams
authors.affiliation: Baylor Healthcare System, Plano, Texas.
authors.forename: Michael
authors.initials: M
authors.lastname: Mack
authors.affiliation: Columbia University Medical Center/New York Presbyterian Hospital, New York, New York; Cardiovascular Research Foundation, New York, New York.
authors.forename: Susheel K
authors.initials: SK
authors.lastname: Kodali
authors.affiliation: Cleveland Clinic Foundation, Cleveland, Ohio.
authors.forename: Lars G
authors.initials: LG
authors.lastname: Svensson
authors.affiliation: Columbia University Medical Center/New York Presbyterian Hospital, New York, New York; Cardiovascular Research Foundation, New York, New York.
authors.forename: Ajay J
authors.initials: AJ
authors.lastname: Kirtane
authors.affiliation: Cardiovascular Research Foundation, New York, New York.
authors.forename: Ke
authors.initials: K
authors.lastname: Xu
authors.affiliation: Cardiovascular Research Foundation, New York, New York.
authors.forename: Thomas C
authors.initials: TC
authors.lastname: McAndrew
authors.affiliation: Cedars Sinai Medical Center, Los Angeles, California.
authors.forename: Raj
authors.initials: R
authors.lastname: Makkar
authors.affiliation: Columbia University Medical Center/New York Presbyterian Hospital, New York, New York.
authors.forename: Craig R
authors.initials: CR
authors.lastname: Smith
authors.affiliation: Columbia University Medical Center/New York Presbyterian Hospital, New York, New York; Cardiovascular Research Foundation, New York, New York. Electronic address: mleon@crf.org.
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000379:methods*; D015150:Echocardiography, Doppler; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000379:methods* / Q000401:mortality*; D006801:Humans; D015994:Incidence; D053208:Kaplan-Meier Estimate; D008297:Male; D061214:Patient Safety; D019106:Postoperative Hemorrhage / Q000175:diagnosis / Q000453:epidemiology*; D011237:Predictive Value of Tests; D018570:Risk Assessment; D012720:Severity of Illness Index; D015996:Survival Rate; D016896:Treatment Outcome
keywords: aortic stenosis; bleeding; surgical aortic valve replacement; transcatheter aortic valve implantation; transcatheter aortic valve replacement