Asian TAVR Registry Shows Good Procedural and Clinical Results
New registry data presented at TCT 2015 shed light on
real-world outcomes of transcatheter aortic valve replacement (TAVR) in Asia.
Sung-Han Yoon, MD, of Asan Medical Center, Seoul, South Korea, reported results from the Asian TAVR registry, which included 940 patients (mean age 82.1 years; 52.9% women) at 12 centers in six countries treated between February 2009 and February 2015.
Most cases (85.8%) were performed using the transfemoral approach, while 12% were done transapically (12%). Mean logistic EuroSCORE was 21.6%, and the mean Society of Thoracic Surgeons (STS) score was 7%.
There was no difference in 30-day mortality between patients implanted with the Sapien XT (Edwards Lifesciences; n = 615) and CoreValve devices (Medtronic; n = 325), but use of the former was associated with lower mortality at 1 year. Device success was higher with Sapien XT, but all other secondary endpoints including stroke and bleeding were similar between the devices (see Table).
Table. Asian TAVR Registry Outcomes
Moderate or greater paravalvular regurgitation occurred
in 9.5% of all patients in the registry. A combined safety endpoint at 30 days
was met in 81% of all patients, with no difference between the device groups (P= .51).
The researchers also stratified results by STS score. Patients with a score lower than 3% had a 2-year survival rate of 91.2%, compared with 86.4% for those with a score between 3% and 8% (P = .15) and 77.3% for those with a score higher than 8% (P = .001). Patients with scores of 3 -8% also had better survival than those in the highest group (P = .001).
On multivariate analysis, independent predictors of reduced survival were female sex, chronic kidney disease, diabetes, pulmonary disease, peripheral vascular disease, mild or greater paravalvular regurgitation and higher STS score.
Yoon stressed that forthcoming data from the PARTNER II
and SURTAVI trials are necessary to make more firm conclusions and information
on long-term durability is not yet available. Still, he said, “these results
encourage the current trend of expanding indication of TAVR toward younger and
lower risk groups. Given the improved outcomes with new generation devices, I
expect a bright future for TAVR.”
Disclosures:
- Yoon reports no relevant conflicts of interest.
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