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TAVR linked with positive outcomes in Asian population, despite previous concerns of elevated risk
Previous studies have raised concern regarding the risk for major complications and death with transcatheter aortic valve replacement in the anatomy of Asian patients, but its use in a real-world Asian patient population appears to yield favorable outcomes, according to results from the Asian TAVR registry.
In the international, multicenter study, researchers evaluated 848 consecutive patients who underwent TAVR at 11 high-volume centers in Asia between March 2010 and September 2014. The mean age of the patients was 81.8 ± 6.6 years, and the patient population was 53.3% female. The mean Society of Thoracic Surgeons (STS) score of the population was 5.2 ± 3.8%. Patients were implanted with a balloon-expandable valve (Sapien, Edwards Lifesciences; n = 549; 64.7%) or a self-expanding valve (CoreValve, Medtronic; n = 299; 35.3%).
Primary outcomes in the Asian TAVR registry included any-cause mortality at 1 month and at 1 year. Secondary outcomes included cardiac death, stroke, bleeding events, vascular complications, acute kidney injury and device success. Clinical follow-up data were collected at 1, 6, 12 and 24 months.
TAVR achieved a procedural success rate of 97.5%. Conversion to open heart surgery was required in 1.8% of patients. Coronary obstruction occurred in 1.3% of patients.
Rates of death from any cause were 2.5% at 30 days and 10.8% at 1 year. No differences in 1-year mortality were seen between the two devices (Sapien, 9.4%; CoreValve, 12.2%; log-rank P = .4). A significant difference in mortality was observed between patients at low, intermediate and high surgical risk according to STS score (HR of STS 4-8 vs. STS < 4 = 2.2; 95% CI, 1.39-3.47).
The rates of the secondary outcome measures were as follows: stroke, 3.8%; life-threatening bleeding, 6.4%; major vascular complications, 5%; and stage 2 to 3 acute kidney injury, 3.3%. The CoreValve device had a higher prevalence of moderate or severe paravalvular leakage vs. the Sapien device (14.4% vs. 7.3%; P = .001). On multivariate analysis, the following factors were found to be significantly correlated with mortality: higher STS score, lower BMI, NYHA functional class III to IV symptoms, diabetes, previous cerebrovascular accident, low baseline mean gradient, and moderate or severe paravalvular leakage.
“Despite concerns regarding the safety and effectiveness of TAVR in Asian patients with anatomic features, clinical outcomes of TAVR using balloon-expandable or self-expanding prostheses in Asian populations were comparable with previous published trials and observational studies from Western countries,” the researchers wrote. “Additional studies are needed to evaluate the safety and efficacy of TAVR in Asian populations during long-term follow-up.” – by Jennifer Byrne
Disclosure: Four researchers report serving as proctors for Edwards Lifesciences.