Mechanically expanded transcatheter aortic valve replacements may be just as effective as self-expanding aortic valve replacements for patients with aortic stenosis, according to a study published in JAMA.
Ted E Feldman, MD, of the Evanston Hospital Cardiology Division at Northshore University Health System in Illinois, and associates conducted a series of randomized tests using the Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System (REPRISE III) clinical trial to compare MEV with SEV in patients undergoing transcatheter aortic valve replacement (TAVR).
The main outcomes were safety (30-day measure) and effectiveness (1-year measure) end points. The safety end point measured noninferiority of MEV in all-cause mortality, stroke, extreme bleeding, stage 2/3 acute kidney injury, and any severe complications or damage to vasculature. For the effectiveness end point, which also measured for noninferiority, the researchers monitored all-cause mortality, stroke, and moderate to severe paravalvular leaks. If noninferiority conditions were met, a secondary end point (1-year measure) for superiority of MEV was conducted by testing for moderate or severe paravalvular leaks.
Of the 1232 screened patients, 912 with high or severe risk and severe symptomatic aortic stenosis were randomly sorted to receive either the mechanically expanded lotus valve system (MEV) or the self-expanding CoreValve (SEV). The ratio of distribution was 2:1 for MEV (n=607) and SEV (n=305), respectively. Patient mean age was 82.8 at baseline.
The primary 30-day safety end point yielded a 3.1% difference between the 2 TAVR groups: 20.3% of MEV group patients and 17.2% of SEV group patients. The primary 1-year effectiveness end point yielded a -10.1% difference between MEV and SEV groups: 15.4% and 25.5% of patients in MEV and SEV groups, respectively.
The secondary end point resulted in 0.9% of MEV patients and 6.8% of SEV patients (difference, -6.1%) testing positive for paravalvular leakage. In addition, MEV patients had more implanted pacemakers (35.5%) than SEV patients (19.6%). Conversely, MEV patients had less procedures repeated (0.2% vs 2.0%), valve-in-valve deployments (0% vs 3.7%), and valve mal-positioning (0% vs 2.7%) compared with SEV patients.
“Among high-risk patients with aortic stenosis, use of the MEV compared with the SEV did not result in inferior outcomes for the primary safety end point or the primary effectiveness end point,” the authors concluded.
“These findings suggest that the MEV may be a useful addition for TAVR in high-risk patients.”
- Feldman TE, Reardon MJ, Rajagopal V, et al. Effect of mechanically expanded vs self-expanding transcatheter aortic valve replacement on mortality and major adverse clinical events in high-risk patients with aortic stenosis: The REPRISE III randomized clinical trial. JAMA. 2018 Jan 2. doi:10.1001/jama.2017.19132