Courtesy of Dr. Carlos Fava.

Transcatheter aortic valve replacement (TAVR) has proven to be beneficial for extreme- and high-risk patients. It is also increasingly used in intermediate-risk patients, and it has been hinted at for low-risk patients. However, different sectors in the medical community still challenge the existence of real TAVR benefit.

This assessment consisted in a meta-analysis including data from 7 trials (2 of them randomized trials) with intermediate-risk patients who presented severe aortic stenosis. This study included 4601 patients; 2305 subjects who underwent TAVR, and 2296 who underwent surgical aortic valve replacement.

There were no significant differences in 30-day all-cause mortality among groups.

Follow-up at 1.15 years showed no significant difference in all-cause death, acute myocardial infarction, and stroke. TAVR resulted in lower rates of acute kidney injury (4.6% vs. 8.1%; odds ratio [OR]: 0.53; 95% confidence interval [CI]: 0.38-0.74; number needed to treat [NNT] = 26; p = <0.001; I² = 35%), major bleeding (18.1% vs. 44.6%; 0.54; 95% CI: 0.31-0.93; NNT = 4; p = 0.03; I² = 82%), and new atrial fibrillation (10.9% vs. 26.7%; risk ratio [RR]: 0.41; 95% CI: 0.33-0.50; NNT =  6; p > 0.001). However, it also resulted in higher rates of major vascular complications (8.5% vs. 3.1%; RR: 7.87; 95% CI: 1.49-41.69; number needed to harm (NNH) = 1; p = 0.02; I² = 83%), permanent pacemaker implantation (13.5% vs. 7.7%; RR: 2.26; 95% CI: 1.20-4.27; NNH = 17; p = 0.01, I² = 77%), and moderate/severe aortic regurgitation (13.3% vs. 8.9%; RR: 6.93; 95% CI: 3.28-14.64; NNH = 13; p < 0.001; I² = 27%).

The rate of permanent pacemaker implantation was significantly higher with TAVR in observational studies than in randomized studies.

Conclusion

This analysis of mid-term results showed that TAVR has similar clinical efficacy to surgical aortic valve replacement in intermediate-risk patients with severe aortic stenosis, and can be a suitable alternative to surgical aortic valve replacement.

Editorial Comment

While these results encourage the use of TAVR in intermediate-risk patients, mid-term follow-up is still the limit. The behavior of valves at 10 years or longer remains unknown, since expected survival for this group is much longer than for high- or prohibitive-risk patients.

These patients need to be monitored over time, and technology for the reduction of complications must be developed (particularly for cases in which surgery is still better than TAVR), so that we can offer a global solution to our patients.

Courtesy of Dr. Carlos Fava.

Original title: Transcatheter Versus Surgical Aortic Valve Replacement in Intermediate-Risk Patients: Evidence from a Meta-Analysis

Partha Sardar et al. Catheterization and Cardiovasc Intev 2017 Early View

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