Study Shows Improved Outcomes With New-Generation TAVR Devices to Treat Pure Native Aortic Regurgitation
December 1, 2017—Findings from a study that aimed to compare the outcomes of transcatheter aortic valve replacement (TAVR) with early and new-generation devices in symptomatic patients with aortic regurgitation (AR) were published by Sung-Han Yoon in Journal of the American College of Cardiology (JACC; 2017;70:2752–2763).
Using data from the pure native AR TAVR multicenter registry, the investigators assessed procedural and clinical outcomes according to the Valve Academic Research Consortium's VARC-2 criteria and compared between early and new-generation devices.
As summarized in JACC, a total of 331 patients with a mean Society of Thoracic Surgeons (STS) score of 6.7 ± 6.7 underwent TAVR. The early and new-generation devices were used in 119 patients (36%) and 212 patients (64%), respectively.
The STS score tended to be lower in the new-generation device group (6.2 ± 6.7 vs 7.6 ± 6.7; P = .08). Transfemoral access was more frequently used in the early generation device group (87.4% vs 60.8%; P < .001).
The investigators reported that compared with the early generation devices, the new-generation devices were associated with a significantly higher device success rate (81.1% vs 61.3%; P < .001) with lower rates of second valve implantation (12.7% vs 24.4%; P = .007) and postprocedural AR greater than or equal to ;moderate (4.2% vs 18.8%; P < .001). There were no significant differences in major 30-day endpoints between the two groups.
The cumulative rates of all-cause and cardiovascular death at 1-year follow-up were 24.1% and 15.6%, respectively. The 1-year all-cause mortality rate was significantly higher in the patients with postprocedural AR greater than or equal to moderate compared with those with postprocedural AR less than or equal to mild (46.1% vs 21.8%; log-rank P = .001). On multivariable analysis, postprocedural AR greater than or equal to moderate was independently associated with 1-year all-cause mortality (hazard ratio, 2.85; 95% confidence interval, 1.52–5.35; P = .001).
Compared with the early generation devices, TAVR using the new-generation devices was associated with improved procedural outcomes in treating patients with pure native AR. Additionally, in patients with pure native AR, significant postprocedural AR was independently associated with increased mortality, concluded the investigators in JACC.