Transcatheter aortic valve replacement (TAVR) with the Evolut PRO valve demonstrated consistent favorable clinical and hemodynamic outcomes through 3 years post-implant, according to data from the FORWARD PRO post-market study. Nicolas M. Van Mieghem, MD, PhD, of Erasmus Medical Center, Rotterdam, Netherlands, presented these findings Tuesday at EuroPCR 2022 in Paris. TAVR technologies have rapidly changed in the 20 years since the first procedure. Valve iterations to mitigate paravalvular leak, such as the Evolut PRO valve’s external porcine pericardial wrap, have been developed. Early outcomes through 1 year have been promising, but longer-term data are needed. With that in mind, Van Mieghem presented the 3-year outcomes after TAVR with the Evolut PRO on behalf of the FORWARD PRO investigators. The Evolut PRO is a supra-annular porcine pericardial valve within a nitinol frame. The valve is repositionable and features an external pericardial wrap. FORWARD PRO is a prospective, non-randomized, interventional, post-market study that enrolled patients undergoing TAVR in routine clinical practice from February 2018 to January 2019. These patients had native aortic-valve stenosis or a failed surgical bioprosthetic valve underwent TAVR with an Evolut PRO valve (23, 26 or 29 mm), and they were at high or greater risk for surgery or 75 years or older and at intermediate risk (Society of Thoracic Surgeons [STS] risk score of 4% or higher) according to the treating heart team. The primary endpoint was all-cause mortality at 30 days. The study protocol specified echocardiographic acquisition at baseline, discharge and 1 and 3 years, and these echoes were assessed by an independent core laboratory. All death and safety events were independently adjudicated by a clinical events committee. A total of 638 patients were enrolled, and TAVR was attempted in 629. At baseline, the patients’ mean age was 81.7 ± 6.1 years, 61.8% were female, mean STS risk score was 4.7% ± 3.3%, 64% were New York Heart Association (NYHA class III or IV), 33.6% were considered frail, and 14.8% were in assisted living. At 3 years, Kaplan-Meier estimate showed that 25% of the patients had died (up from 9.7% at 1 year and 16.6% at 2 years), 6.5% experienced a disabling stroke (up from 4.6% at 1 year and 5.4% at 2 years), and 2.4% of the valves had endocarditis (up from 1.4% at 1 year and 2.2% at 2 years). Rates of reintervention (1.3%) and thrombosis (0.2%) were low at 3 years. The Kaplan-Meier curve for the composite of death or disabling stroke showed the rate was 28% (95% confidence interval [CI]: 25.0%, 32.5%), which was up from 19.4% (95% CI: 16.4%, 22.8%) at 2 years and 12% (95% CI: 9.6%, 14.9%) at 1 year. Meanwhile, the Kaplan-Meier curve for new permanent pacemaker held relatively steady after the first 30 days. At 3 years, the estimate was 24.7% (95% CI: 20.7%, 29.3%), up from 24% (95% CI: 20.3%, 28.2%) at 2 years and 22.7% (95% CI: 19.2%, 26.6%) at 1 year. At 3 years, improves in valve effective orifice area and mean gradient were largely sustained. At baseline, the patients’ mean aortic-valve gradient was 43.0 ± 16.0 mmHg, which improved to 7.9 ± 4.7 mmHg at discharge and was 8.8 ± 4.7 mmHg at 3 years. Mean effective orifice area was 0.8 ± 0.3 cm2 at baseline, which improved to 2.1 ± 0.6 cm2 at discharge and was 2.0 ± 0.5 cm2 at 3 years. Meanwhile, among patients with available echocardiograms, the percentage with none or trace paravalvular leak improved from 59.5% at discharge to 80.3% at 3 years. Looking only at patients with available echocardiograms at all follow-up visits (discharge and 1 and 3 years), the percentage with none or trace paravalvular leak improved from 62.3% at discharge to 80.9% at 3 years. Meanwhile, moderate or worse paravalvular leak improved from 1.6% at discharge to 0% at 3 years among all patients with available echoes, and from 2.1% at discharge to 0% at 3 years among only patients with available echoes at all follow-up visits. Heart failure symptom improvement also was largely sustained at 3 years. The percentage of patients in NYHA class I or II was 92% at 30 days, 89.7% at 1 year and 84.4% at 3 years. Van Mieghem added that there were seven reinterventions, two of which happened the same day as the procedure (one was a valve-in-valve for a valve embolization, the other was a snared Evolut and second valve implanted after a valve migration). Of the remaining five reinterventions, three were valve-in-valve to correct paravalvular leak, one was a surgical explant because of endocarditis, and the last was a valve-in-valve because of aortic insufficiency. The FORWARD PRO study was sponsored by Medtronic, which performed the statistical analysis and assisted in the development of slides presented at EuroPCR.