Trends in Complications and Outcomes of Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement: Experience From the PARTNER Continued Access Registry

JACC Cardiovasc Interv. 2016 Feb 22;9(4):355-363. doi: 10.1016/j.jcin.2015.10.050. Epub 2016 Jan 20.


Objectives: 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).

Keywords: TAVR; complications; transcatheter aortic valve replacement; trends.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Valve Insufficiency / etiology
  • Aortic Valve Insufficiency / physiopathology
  • Aortic Valve* / physiopathology
  • Cardiac Catheterization / adverse effects*
  • Cardiac Catheterization / instrumentation
  • Cardiac Catheterization / trends*
  • Catheterization, Peripheral / adverse effects
  • Catheterization, Peripheral / trends*
  • Cause of Death / trends
  • Comorbidity
  • Female
  • Femoral Artery*
  • Heart Valve Diseases / diagnosis
  • Heart Valve Diseases / therapy*
  • Heart Valve Prosthesis Implantation / adverse effects
  • Heart Valve Prosthesis Implantation / instrumentation
  • Heart Valve Prosthesis Implantation / trends*
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Multivariate Analysis
  • Proportional Hazards Models
  • Registries
  • Risk Factors
  • Time Factors
  • Treatment Outcome

Associated data