Short- and mid-term mortality risks are similar in aortic stenosis for surgical and transcatheter approaches to aortic valve replacement (SAVR and TAVR, also known as TAVI), a meta-analysis found.
Mortality at 30 days was no more likely with TAVR than SAVR (odds ratio [OR] 1.01, 95% CI 0.81-1.26), nor was there any difference at 1 year (OR 0.96, 95% CI 0.81-1.14), Giovanni Esposito, MD, PhD, of Federico II University of Naples, Italy, and colleagues reported online in the Annals of Internal Medicine.
In the long term, at 2 to 5 years, death tended to be more common after TAVR, although this was a pattern that failed to reach statistical significance (OR 1.28, 95% CI 0.97-1.69).
Findings from studies of low- to intermediate-risk patients after TAVR trended — without reaching statistical significance — toward reduced 30-day (OR 0.67, 95% CI 0.42-1.07) and 1-year mortality (OR 0.91, 95% CI 0.67-1.23). But neither treatment was associated with a survival advantage in the long-term for that low- to intermediate-risk group (OR 1.06, 95% CI 0.59-1.91).
“Compared with SAVR, TAVI may have similar or better early and midterm outcomes for adults with aortic stenosis, including those at low to intermediate risk,” the investigators concluded.
A transfemoral approach in TAVR was associated with a survival advantage, however. Death at 30 days was less likely for these patients versus those getting SAVR (OR 0.68, 95% CI 0.53-0.87), as was death at 1 year (OR 0.80, 95% CI 0.68-0.93).
TAVR with a transapical approach didn’t turn up significant differences from surgery for early mortality (OR 1.27, 95% CI 0.15-10.9) or midterm mortality (OR 1.41, 95% CI 0.51-3.86).
“These findings, which apply to adults with severe aortic stenosis, consolidate the role of TAVI as an alternative to SAVR,” Esposito’s group noted. Indeed, “increasing expertise, new-generation TAVI devices, and the transfemoral approach might lead to better long-term comparative results from TAVI in the near future,” they wrote.
The authors also found TAVR better at 30 days for risk of the following:
- Myocardial infarction (OR 0.51, 95% CI 0.38-0.69)
- Major bleeding (OR 0.49, 95% CI 0.26-0.95)
- Acute kidney injury (OR 0.50, 95% CI 0.34-0.73)
- New-onset atrial fibrillation (OR 0.24, 95% CI 0.15-0.40)
Yet TAVR did show higher odds for early cases of:
- Pacemaker implantation (OR 2.32, 95% CI 1.62-3.31)
- Vascular complications (OR 4.32, 95% CI 1.82-10.3)
- Paravalvular leak (OR 6.66, 95% CI 5.26-8.45)
“As the result of smaller sheaths and improved procedural techniques,” they suggested, TAVR might yet overcome problems with paravalvular leak, pacemaker implantation, and vascular complications.
Esposito’s meta-analysis included 16,638 patients from 36 studies (five randomized trials and 31 observational studies).
Restricting the analysis to randomized trials, the group still failed to pinpoint the better strategy for avoiding early (OR 0.80, 95% CI 0.51-1.25) and midterm mortality (OR 0.90, 95% CI 0.64-1.26).
Esposito’s group noted limitations of the meta-analysis included that “there were few trials and, in some instances, few events,” adding that “confidence bounds around some of the summary estimates of effect were too wide to rule out potentially important benefits or harms from TAVI versus SAVR.”
They also had little long-term data, “which is a particularly critical limitation because valve durability is a major unknown of TAVI and an important issue when considering the procedure for younger or lower-risk patients.”
Longer-term follow-up data is currently being collected in the PARTNER, U.S. CoreValve, PARTNER 2A, and NOTION trials.
Esposito reported no relevant conflicts of interest.
Annals of Internal Medicine
Gargiulo G, et al “Transcatheter aortic valve implantation versus surgical aortic valve replacement: a systematic review and meta-analysis” Ann Intern Med 2016; DOI: 10.7326/M16-0060.