Is TAVR Ready for Prime Time in Low-Risk Patients?
Michael J. Mack M.D.
Mack, M. J. (2018). “Is TAVR Ready for Prime Time in Low-Risk Patients?” J Am Coll Cardiol 72(18): 2106-2108.
Transcatheter aortic valve replacement (TAVR) has been demonstrated in randomized controlled trials (RCTs) to be superior to medical therapy in inoperable patients with severe symptomatic aortic stenosis and to be noninferior to surgical aortic valve replacement (SAVR) in high and intermediate surgical risk patients. TAVR has thus become widely accepted as the standard of care in these patient cohorts due in large part to the robust body of evidence generated by 6 RCTs. We also have some outcome data in low-risk patients from a single randomized trial, NOTION (Nordic Aortic Valve Intervention Trial; NCT01057173). There are 2 more RCTs comparing TAVR with SAVR in low surgical risk patients with 2 different devices that have now completed enrollment of approximately 2,000 patients, and the outcomes of these trials are expected to become available in early 2019 . . . With this background in mind, we now consider the study by Waksman et al. reported in this issue of the Journal. It is an observational, nonrandomized study of 200 low surgical risk patients with severe symptomatic aortic stenosis who underwent TAVR. The primary endpoint of the study is all-cause mortality at 30 days. Important exclusions included bicuspid aortic valves and unsuitability for transfemoral access. The mean age was 73.6 years, and the STS PROM (Society of Thoracic Surgeons Predicted Risk of Mortality) was 1.8. A balloon-expandable valve, Sapien 3 (Edwards Lifesciences, Irvine, California), was used in 88.2% of the patients and a self-expanding valve, CoreValve Evolut R (Medtronic, Dublin, Ireland), in 11.8%. Notable procedural findings are that 75% of the procedures were performed without general anesthesia, all by transfemoral access, and there was 1 conversion to surgery due to coronary artery obstruction (0.5%). The 30-day results are excellent in that there was no mortality and a 0.5% stroke rate. Also of note is that there was a low incidence of the need for new permanent pacemaker implantation (5%) and a low rate of new-onset atrial fibrillation (3%), and there were 2 patients (1.0%) with a moderate-severe paravalvular leak at discharge. (Commentary on Waksman et al. 2018. Transcatheter aortic valve replacement in low-risk patients with symptomatic severe aortic stenosis. J Am Coll Cardiol, 72.)