A meta-analysis evaluated 12 studies that included a total of 37,825 participants with intermediate-to-high surgical risk who underwent either TAVR or SAVR from 1966 through January 2023 for severe symptomatic aortic stenosis to compare short-term and long-term outcomes. The primary endpoints were all-cause mortality and 30-day mortality. Secondary endpoints included stroke, new-onset atrial fibrillation, pacemaker implant, vascular and respiratory complications, cardiac tamponade and blood transfusion.
The researchers found no statistical differences in the rate of death [risk ratio (RR) 1.03, 95% confidence interval (CI) 0.74-1.45], new-onset atrial fibrillation (RR 0.36, 95% CI 0.11-1.26), vascular complications (RR 1.33, 95% CI 0.88-2.02), 30-day mortality (RR 0.84, 95% CI 0.33-2.15) or cardiac tamponade (RR 0.48, 95% CI 0.62-0.92).
TAVR was associated with a 25% reduction in risk of stroke (RR 0.75, 95% CI 0.62-0/92) and 68% reduction in risk of respiratory complications (RR 0.32, 95% CI 0.2-0.52). TAVR was associated with an increased risk of permanent pacemaker implantation (RR 2.03, 95% CI 1.54-2.67).[i]
Positive results for low-risk patients
Patients with symptomatic severe aortic stenosis who have low surgical risk have only been indicated for TAVR for five years, so long-term data has been scarce. Still, the relatively quick recovery time and minimally invasive nature of the surgery, as well as early results indicating non-inferiority to SAVR have made TAVR the preferred procedure in this population.
The PARTNER 3 trial randomized 1000 participants to TAVR using the SAPIEN 3 valve (503) or SAVR (497). Participants had a mean age of 73 and 30% were female.
At one year, the primary outcome of all-cause mortality, stroke or rehospitalizations related to the procedure, valve or heart failure occurred in 8.5% of the TAVR arm and 15.1% of the SAVR group. At two years, 11.5% of those in the TAVR arm and 17.4% of participants in the SAVR arm experienced the primary outcome. Through five years the TAVR arm continued to have lower rates of all-cause mortality, stroke and rehospitalization compared to SAVR, at 22.8% and 27.2%, respectively.
New-onset atrial fibrillation occurred in 5% of TAVR participants and 39.5% of those who had SAVR; at five years, atrial fibrillation developed in 13.7% of TAVR participants and 42.4% of those in the SAVR arm. A permanent pacemaker was required in 6.5% of those who underwent TAVR compared to 4.0% of those who had SAVR within five years.
Repeat aortic valve intervention was required in 2.6% of the TAVR arm and 3.0% of the SAVR arm within five years. Bioprosthetic valve failure occurred in 3.3% of TAVR patients and 3.8% of SAVR patients.[ii]
The Evolut Low-Risk Trial showed similar results in patients at low surgical risk at four years. That study enrolled 1,414 patients, of whom 730 underwent TAVR and 684 had surgical valve replacement. At four years, 94.7% of the TAVR patients and 89.2% of the SAVR patients had evaluable results. Mean age of participants was 74 years and 35% were female.
At four years, 10.7% of the TAVR arm and 14.1% of the SAVR arm experienced the study’s primary endpoint of all-cause mortality or disabling stroke. Valve reintervention was required in 1.3% of the TAVR group and 1.7% of the SAVR group and 24.6% of TAVR participants and 9.9% of the SAVR participants required permanent pacemaker implants at four years post-procedure.[iii]
