SAPIEN 3 transcatheter aortic valve replacement (TAVR) is non-inferior to surgical aortic valve replacement (SAVR) in intermediate-risk patients with severe aortic stenosis at 5 years, according to mid-term follow-up data. The study, published online Monday and in the July 11 issue of the Journal of the American College of Cardiology, noted that previous studies with an earlier-generation balloon-expandable valve demonstrated TAVR to be non-inferior to SAVR for death and disabling stroke in intermediate-risk patients with symptomatic, severe aortic stenosis at 5 years. However, the team led by Mahesh V. Madhavan, MD, MS, from Columbia University Irving Medical Center and NewYork-Presbyterian Hospital, and the Cardiovascular Research Foundation, New York, noted that limited long-term data are available with the more contemporary SAPIEN 3 (S3) bioprosthesis. “Despite these encouraging early data and widespread adoption of the S3 TAVR platform, long-term clinical and echocardiographic follow-up comparing S3 TAVR with SAVR remains limited,” said the authors. “We therefore sought to evaluate and compare 5-year outcomes in intermediate-risk patients from the P2S3i study and the surgical arm of the P2A randomized clinical trial using a propensity-matched analysis.” Study details Madhavan and colleagues compared 5-year risk-adjusted outcomes in 783 matched pairs of intermediate-risk patients with severe aortic stenosis undergoing S3 TAVR in the PARTNER 2 (Placement of Aortic Transcatheter Valves) S3 single-arm study and SAVR in the PARTNER 2A randomized clinical trial. The team used propensity-score matching to account for baseline differences, and the primary composite endpoint consisted of 5-year all-cause death and disabling stroke. Median follow-up duration for the matched cohort was 4.70 years (interquartile range [IQR]: 2.56-5.06 years), with follow-up data available at 5 years for 641 patients with S3 TAVR (81.9%) and 680 patients with SAVR (86.8%), they added. “The majority of patient baseline clinical characteristics were similar between the matched groups. An exception was a statistically significant difference in baseline aortic valve area (0.69 cm2 vs 0.71 cm2; P = 0.03) between the S3 TAVR and SAVR groups,” noted Madhavan and colleagues. Rates of the primary composite endpoint of death or disabling stroke were not significantly different between S3 TAVR and SAVR in the propensity-matched cohort at 5-year follow-up (40.2% vs 42.7%; hazard ratio [HR]: 0.87; 95% confidence interval [CI]: 0.74-1.03; P = 0.10), reported the team. They added that rates of all-cause death were similar between groups at 5-year follow-up (39.2% vs 41.4%; HR: 0.90; 95% CI: 0.76-1.06; P = 0.21), while disabling stroke occurred less frequently after S3 TAVR than after SAVR (5.8% vs 7.9%; HR: 0.66; 95% CI: 0.43- 1.00; P = 0.0046). Overall stroke rates were similar between groups at 5-year follow-up (13.4% vs 11.4%; HR: 1.09; 95% CI: 0.80-1.48; P = 0.58); however, non-disabling stroke was more common after S3 TAVR than after SAVR at 5-year follow-up, the team said. Rates of cardiac death; noncardiac death; transient ischemic attack; rehospitalization; death or rehospitalization; and the composite of death, stroke or rehospitalization did not differ significantly between groups at 5-year follow-up, said the authors. While rates of structural valve deterioration–related hemodynamic valve deterioration were similar, the incidence of mild or greater paravalvular regurgitation was more common after S3 TAVR, they said, noting that longer-term follow-up is needed to further evaluate differences in late adverse clinical events and bioprosthetic valve durability. Questioning the lifetime management of TAVR Writing in an accompanying editorial, Subodh Verma, MD, PhD, from St. Michael’s Hospital, University of Toronto, alongside Deepak L. Bhatt, MD, MPH, and Gilbert H.L. Tang, MD, MSc, MBA, both from the Icahn School of Medicine at Mount Sinai, New York, noted that among intermediate-risk patients, aortic valve reintervention after TAVR at 5 years remains rare, but noted that the incidence appeared higher than after SAVR. “As we have learned from the surgical literature, valve reintervention rate underestimates the true rate of structural valve deterioration, because patients who died of valve failure, those without echocardiographic follow-up, and those who refused or were declined reintervention would not have been captured,” they warned. Indeed, the editorialists added that although the new study by Madhavan and colleagues stated the incidence of structural valve deterioration was similar between TAVR and SAVR, echocardiographic follow-up was missing in 23% of patients with TAVR and 33.7% of patients with SAVR at 5 years. “Therefore, we cannot ascertain whether the true structural valve deterioration rates may be higher and whether valve reintervention rates would also be higher,” they said. “Given that the reported valve reintervention rates were consistently higher after TAVR than SAVR, we need to understand better why TAVR requires reintervention more frequently and whether initial procedural result, for example, device under-expansion, may be associated with subsequent need for reintervention,” they said. The commentators added that further investigations into late nondisabling stroke, the long-term impact of mild paravalvular leak, and structural valve deterioration needing reintervention after TAVR, are required. “These issues are key because we are now routinely performing TAVR in younger patients where lifetime management is an important topic of discussion,” they said, noting that “more meticulous imaging follow-up will hopefully help answer some of these questions.” Sources: Madhavan MV, Kodali SK, Thourani VH, et al. Outcomes of SAPIEN 3 Transcatheter Aortic Valve Replacement Compared With Surgical Valve Replacement in Intermediate-Risk Patients. J Am Coll Cardiol 2023;82:109-123. Verma S, Bhatt DL, Tang GHL. Mid-Term Outcomes of TAVR in Intermediate-Risk Patients: Potential Targets for Improvement. J Am Coll Cardiol 2023;82:124-127. Image Credit: iushakovsky – stock.adobe.com