One-Year PARTNER EU Results Reported for High-Risk Patients Treated With Edwards Sapien Valve

December 1, 2010—One-year follow-up results of the multicenter PARTNER EU (European Placement of Aortic Transcatheter Valve Trial) study of transcatheter heart valve implantation (TAVI) have been published by Thierry Lefévre, MD, et al online ahead of print in the European Heart Journal.

According to the investigators, PARTNER EU is prospectively evaluating the procedural and midterm outcomes of transfemoral (TF) or transapical (TA) implantation of the Edwards Sapien transcatheter aortic valve (Edwards Lifesciences, Irvine, CA), which involves a multidisciplinary approach. Primary safety endpoints were 30-day and 6-month mortality. Primary efficacy endpoints were hemodynamic and functional improvement at 12 months.

The investigators reported that 130 patients (61 TF, 69 TA), aged 82.1 ± 5.5 years were included in the study. TA patients had a higher logistic EuroSCORE (33.8% vs 25.7%; P = .0005) and more peripheral disease (49.3% vs 16.4%; P < .0001). Procedures were aborted in four TA cases (5.8%) and six TF cases (9.8%), and TAVI was successful in the remaining 95.4% and 96.4%, respectively.

At 30 days and 6 months, survival rates were 81.2% and 58% for TA patients, respectively, and 91.8% and 90.2% for TF patients, respectively. In both groups, the mean aortic gradient decreased from 46.9 ± 18.1 mm Hg to 10.9 ± 5.4 mm Hg at 6 months after implantation. In total, 78.1% of TA patients and 84.8% of TF patients experienced significant improvement in New York Heart Association class, whereas 73.9% of TA and 72.7% of TF patients had improved Kansas City Cardiomyopathy Questionnaire scores.

The PARTNER EU investigators concluded that this first team-based, multicenter, European TAVI registry shows promising results in high-risk patients treated by TF or TA delivery. Survival rates differ significantly between TF and TA groups and probably reflect the higher-risk profile of the TA cohort. The investigators advised that optimal patient screening, approach selection, and device refinement may improve outcomes.