title: Trends in Complications and Outcomes of Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement: Experience From the PARTNER Continued Access Registry.
abstract: OBJECTIVE
  The aim of this study was to examine trends in the rates of complications and outcomes of patients undergoing transfemoral transcatheter aortic valve replacement (TF-TAVR).
  
  
  BACKGROUND
  It is unknown whether an evolution of case selection or accrual of case experience over time has resulted in a change in the rates of complications and outcomes of patients undergoing TF-TAVR.
  
  
  METHODS
  TF-TAVR patients enrolled in the PARTNER (Placement of AoRTic TraNscathetER Valve Trial) nonrandomized continued access registry (N = 1,063, enrolled March 2011 to January 2012 after completion of the randomized trial) were divided into tertiles (T1 through T3) based on enrollment date. Patient characteristics and rates of adverse events were compared over time.
  
  
  RESULTS
  There were no significant differences in sex, New York Heart Association functional classes III/IV, diabetes, coronary artery disease, previous revascularization, pulmonary hypertension, renal disease, or liver disease. There was an increase in mean age, but a decrease in porcelain aorta, chronic obstructive pulmonary disease (including oxygen-dependent chronic obstructive pulmonary disease), previous chest wall radiation, and a slight decrease in the median Society of Thoracic Surgeons Predicted Risk of Mortality score. There was a significant decline in the frequency of patients deemed "inoperable" (cohort B) and in need for post-dilation. Percutaneous access increased significantly. There were no differences in post-procedural stroke, major bleeding, major vascular complications, or the need for aortic valve reintervention over time. The incidence of moderate/severe paravalvular regurgitation declined significantly as did all-cause mortality at 1 and 2 years.
  
  
  CONCLUSIONS
  A significant reduction in the incidence of moderate/severe paravalvular regurgitation as well as longer term all-cause mortality was observed over time. The cause of these reductions was likely multifactorial, including improved case selection and procedural techniques and increased site experience. (THE PARTNER TRIAL [Placement of AoRTic TraNscathetER Valve Trial]; NCT00530894).
authors.affiliation: Columbia University, Division of Cardiology, Mount Sinai Medical Center, Miami Beach, Florida. Electronic address: Nirat.Beohar@msmc.com.
authors.forename: Nirat
authors.initials: N
authors.lastname: Beohar
authors.affiliation: Department of Medicine, Columbia University Medical Center/New York Presbyterian Hospital, New York, New York.
authors.forename: Ajay J
authors.initials: AJ
authors.lastname: Kirtane
authors.affiliation: Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Eugene
authors.initials: E
authors.lastname: Blackstone
authors.affiliation: Division of Cardiology, Medstar Washington Hospital Center, Washington, DC.
authors.forename: Ron
authors.initials: R
authors.lastname: Waksman
authors.affiliation: Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.
authors.forename: David
authors.initials: D
authors.lastname: Holmes
authors.affiliation: Division of Cardiology, Medstar Washington Hospital Center, Washington, DC.
authors.forename: Sa'ar
authors.initials: S
authors.lastname: Minha
authors.affiliation: Division of Cardiovascular Disease, University of Alabama-Birmingham, Birmingham, Alabama.
authors.forename: Oluseun
authors.initials: O
authors.lastname: Alli
authors.affiliation: Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Rakesh M
authors.initials: RM
authors.lastname: Suri
authors.affiliation: Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Lars G
authors.initials: LG
authors.lastname: Svensson
authors.affiliation: Department of Medicine, Columbia University Medical Center/New York Presbyterian Hospital, New York, New York.
authors.forename: Martin
authors.initials: M
authors.lastname: Leon
authors.affiliation: Department of Medicine, Columbia University Medical Center/New York Presbyterian Hospital, New York, New York.
authors.forename: Susheel
authors.initials: S
authors.lastname: Kodali
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000503:physiopathology; D001022:Aortic Valve Insufficiency / Q000209:etiology / Q000503:physiopathology; D006328:Cardiac Catheterization / Q000009:adverse effects* / Q000295:instrumentation / Q000639:trends*; D002406:Catheterization, Peripheral / Q000009:adverse effects / Q000639:trends*; D002423:Cause of Death / Q000639:trends; D015897:Comorbidity; D005260:Female; D005263:Femoral Artery; D006349:Heart Valve Diseases / Q000175:diagnosis / Q000628:therapy*; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000639:trends*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D015999:Multivariate Analysis; D016016:Proportional Hazards Models; D012042:Registries; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
keywords: TAVR; complications; transcatheter aortic valve replacement; trends