This article is more than 5 years old. Information may no longer be current.
TAVR yields similar or better short, midterm mortality vs. surgical AVR for severe aortic stenosis
Click Here to Manage Email Alerts
In adults with severe aortic stenosis, including those at low to intermediate risk, transcatheter aortic valve implantation appears to yield comparable or superior early and midterm mortality compared with surgical aortic valve replacement, according to a new meta-analysis.
The systematic review and meta-analysis included five randomized trials and 31 observational matched studies that reported mortality data on adults with severe aortic stenosis who underwent TAVR or surgical AVR. The studies comprised 16,638 patients ranging in age from 70 to 84 years. Most patients had NYHA class III or IV HF. Most studies involved patients with high surgical risk, but six matched studies and two randomized trials enrolled patients with low to intermediate risk.
The primary outcomes of interest were early ( 30 days) and midterm ( 1 year) all-cause mortality. Secondary outcomes included long-term (> 1 year) all-cause mortality; 30-day and midterm stroke; and various periprocedural complications like 30-day CV mortality, MI, permanent pacemaker implantation, major bleeding, vascular complications, acute kidney injury, new diagnosis of atrial fibrillation and moderate-to-severe paravalvular leak.
35 studies comprising 16,386 patients; OR = 1.01; 95% CI, 0.81-1.26). This lack of difference persisted across multiple sensitivity analyses. Analysis stratified by study design revealed a nonsignificant 20% risk reduction with TAVR vs. surgical AVR (five studies comprising 3822 patients; OR = 0.8; 95% CI, 0.51-1.25) in randomized trials, and no evident difference in matched studies (30 studies comprising 6,372 patients; OR: = 1.08; 95% CI, 0.84-1.38), with no significant subgroup interaction (P = .14). Older age, a high prevalence of CAD, history of PCI and use of the Sapien valve (Edwards Lifesciences) were associated with improved treatment effect at 30 days; in contrast, use of the CoreValve (Medtronic) was associated with worse outcomes at 30 days.
Midterm outcomes also showed no difference between TAVR and surgical AVR in terms of all-cause mortality (23 studies comprising 11,222 patients; OR = 0.96; 95% CI, 0.81-1.14). This absence of a significant difference persisted in multiple sensitivity analyses and in the subgroups of randomized trials (5 studies comprising 3,822 patients; OR = 0.9; 95% CI, 0.64-1.26) and matched studies (18 studies comprising 7,400 patients; OR = 1; 95% CI, 0.81-1.24). Improved treatment effect at 1 year was associated with older age, male sex and a high prevalence of CAD; type of valve used did not appear to have an effect on midterm treatment effect.
In analyses limited to studies of patients with low to intermediate risk, the researchers found nonsignificant decreases in both early (eight studies comprising 6,875 patients; OR = 0.67; 95% CI, 0.42-1.07) and midterm (eight studies comprising 6,779 patients; OR = 0.91; 95% CI, 0.67-1.23) mortality after TAVR compared with surgical AVR).
In other results, patients who received transfemoral TAVR had a lower rate of early all-cause mortality (four studies comprising 3,063 patients; OR = 0.68; 95% CI, 0.53-0.87) and midterm all-cause mortality (four studies comprising 3,063 patients; OR = 0.8; 95% CI, 0.68-0.93) compared with surgical AVR. Lower mortality was not observed in patients who received transapical TAVR.
When the researchers examined long-term all-cause mortality, they found a nonsignificant increased risk between TAVR and surgical AVR (10 studies comprising 5,505 patients; OR = 1.28; 95% CI, 0.97-1.69). In patients with low to intermediate risk, long-term mortality was similar between TAVR and surgical AVR (three studies comprising 2,378 patients; OR = 1.06; 95% CI, 0.59-1.91).
In other secondary outcomes, there was no difference between TAVR and surgical AVR in early CV death or stroke; a reduction in MI among patients undergoing TAVR; more permanent pacemaker implantations, vascular complications and moderate to severe paravalvular leak after TAVR; and more major bleeding, acute kidney injury and new-onset atrial fibrillation after surgical AVR.
“These findings, which apply to adults with severe aortic stenosis, consolidate the role of TAV[R] as an alternative to [surgical] AVR,” the researchers concluded. – by Jennifer Byrne
Disclosure: One researcher reports receiving grants from the CardioPath PhD Program, Federico II University of Naples and from the European Association of Percutaneous Coronary Interventions, outside the submitted work. Another researcher reports consulting for Edwards Lifesciences.
Click Here to Manage Email Alerts