Iliofemoral Access TAVR Achieves Best Health Status Outcomes in CoreValve Pivotal Trial

August 21, 2015—In the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions, Susan V. Arnold, MD, et al published results from an evaluation of the health status of patients with severe aortic stenosis at increased surgical risk after undergoing transcatheter aortic valve replacement (TAVR) compared with those who underwent surgical aortic valve replacement (SAVR) in the CoreValve United States pivotal trial (2015;8:1207–1217).

The background of the study is that TAVR with the CoreValve bioprosthesis (Medtronic plc) in patients at increased surgical risk is associated with improved 1-year survival compared with SAVR. The investigators sought to determine if elderly TAVR patients also experienced an improvement in quality of life as a result of treatment.

The investigators concluded that health status for these patients improved substantially when treated with either self-expanding TAVR or SAVR. TAVR via the iliofemoral route was associated with better early health status compared with SAVR, but there was no early health status benefit with noniliofemoral TAVR compared with SAVR. 

Between 2011 and 2012, 795 patients with severe aortic stenosis at increased surgical risk were randomized to TAVR or SAVR in the CoreValve trial. Health status was assessed at baseline, 1 month, 6 months, and 1 year using the Kansas City Cardiomyopathy Questionnaire, Medical Outcomes Study Short-Form 12 Questionnaire, and EuroQOL five-dimension questionnaire. Growth curve models were used to examine changes over time.

The investigators found that over the 1-year follow-up period, disease-specific and generic health status improved substantially for both treatment groups. At 1 month, there was a significant interaction between the benefit of TAVR over SAVR and access site. 

Among surviving patients who were eligible for iliofemoral access, there was a clinically relevant early benefit with TAVR across all disease-specific and generic health status measures. However, among the noniliofemoral access cohort, most health status measures were similar for TAVR and SAVR, although there was a trend toward early benefit with TAVR on the Short-Form 12 Questionnaire’s physical health scale. There were no consistent differences in health status between TAVR and SAVR at the later time points, reported the investigators in JACC: Cardiovascular Interventions.