Highlight
- At 10 years, mortality rates after SAPIEN 3 transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in intermediate-risk patients were similar.
- Aortic valve reintervention rates and valve hemodynamics were comparable between TAVR and surgery, demonstrating sustained valve durability through a decade.
- This study highlights the feasibility and challenges of extended follow-up in elderly cohorts, emphasizing the importance of long-term data in guiding treatment selection.
Study Background
Severe symptomatic aortic stenosis (AS) remains a significant cause of morbidity and mortality, particularly in elderly patients, necessitating timely valve intervention. Surgical aortic valve replacement (SAVR) has traditionally been the gold standard treatment. However, transcatheter aortic valve replacement (TAVR) has evolved as a minimally invasive alternative, increasingly utilized especially in patients with high or intermediate surgical risk.
While randomized controlled trials have demonstrated the short- and mid-term safety and efficacy of TAVR with first- and second-generation devices, data on long-term outcomes—particularly with newer-generation valves such as the third-generation balloon-expandable SAPIEN 3—have been limited. Understanding long-term durability, survival, valve function, and reintervention rates is crucial for optimizing patient selection and clinical decision-making.
Study Design
This analysis integrates data from two complementary prospective multicenter studies conducted in intermediate-risk patients with symptomatic severe AS:
- PARTNER 2A Trial (P2A): A randomized controlled trial enrolling patients from 2011 to 2013, comparing SAVR and TAVR with second-generation SAPIEN XT valves.
- PARTNER 2 SAPIEN 3 Intermediate-risk Registry (P2S3i): A registry enrolling patients in 2014 who received the third-generation SAPIEN 3 valve via transfemoral or transthoracic access.
The current 10-year outcomes focus on patients who underwent TAVR with the SAPIEN 3 valve from P2S3i and those who received surgery in P2A. Key eligibility criteria and intermediate surgical risk profiles were consistent across studies. The primary endpoints assessed were all-cause mortality and aortic valve reintervention. Core laboratory-adjudicated echocardiographic data evaluated valve hemodynamics at 10 years. Propensity score matching (1:1) was employed to balance baseline characteristics between groups, reducing confounding bias.
Key Findings
A total of 2,005 patients received a valve: 1,069 underwent SAPIEN 3 TAVR in the P2S3i registry, and 936 underwent SAVR in the P2A trial. After propensity matching, 783 patient pairs were analyzed with similar baseline profiles: mean age ~82 years, female representation 43%, and Society of Thoracic Surgeons (STS) score averaging 5.5%.
Mortality Outcomes
At 10 years, all-cause mortality occurred in 83.4% of patients in the TAVR group versus 82.3% in the SAVR group. The hazard ratio (HR) was 1.01 (95% confidence interval [CI], 0.91–1.13; P=0.82), indicating no statistically significant difference in survival between the two interventions over a decade.
Aortic Valve Reintervention
The cumulative incidence of valve reintervention adjusted for competing risk of death was low and comparable: 2.0% after TAVR and 1.9% after surgery (P=0.47). This suggests sustained valve durability with the third-generation SAPIEN 3 device, rivaling surgical bioprostheses.
Valve Hemodynamics
Echocardiographic follow-up at 10 years was available for a limited subset (32 TAVR, 30 SAVR patients). Mean aortic valve gradients were similar: 11.0 mm Hg for TAVR and 12.6 mm Hg for SAVR, demonstrating durable valve function without clinically significant stenosis or obstruction.
Additional Considerations
This study recognized challenges inherent in long-term clinical research among elderly populations, including differential loss to follow-up and mortality as a competing event. The requirement for patient reconsent at 5 years, while ethically necessary, likely contributed to attrition in echocardiographic data availability. Nonetheless, the comprehensive attempts to maintain vital status sweeps enhanced mortality data completeness.
Expert Commentary
The durability and clinical performance of the SAPIEN 3 valve demonstrated in this study address prior concerns surrounding long-term structural valve degeneration and the risk of late complications after TAVR. The comparable mortality rates reinforce that, in intermediate-risk patients, TAVR is not only a minimally invasive alternative but also provides equivalent long-term outcomes to surgery.
However, it should be noted that follow-up echocardiographic data beyond 5 years remain sparse, somewhat limiting the characterization of valve durability. Additionally, this analysis involved intermediate-risk elderly patients; extrapolation to younger, low-risk populations or other TAVR valve platforms requires caution. Ongoing evaluation with longer follow-ups and diverse cohorts will continue to shape guidelines.
Conclusion
This landmark 10-year comparison confirms that TAVR with the third-generation balloon-expandable SAPIEN 3 valve yields mortality, valve durability, and hemodynamic outcomes comparable to surgical aortic valve replacement in intermediate-risk patients. It supports the use of TAVR as a durable, less invasive treatment option for symptomatic severe AS in this population. These data contribute critical evidence to patient counseling, shared decision-making, and guideline refinement in valvular heart disease management.
Funding and Clinical Trials Registration
The PARTNER 2A trial is registered under NCT01314313; the PARTNER 2 SAPIEN 3 Intermediate-Risk Registry under NCT03222128. Funding sources and conflicts of interest are disclosed in the original publication.
References
1. Nazif TM, Simonato M, Makkar RR, et al. 10-Year Outcomes of SAPIEN 3 Transcatheter Aortic Valve Replacement or Surgery in Intermediate-Risk Patients. J Am Coll Cardiol. 2026 Jun 16;87(23):3296-3308. PMID: 42300820.
2. Leon MB, Smith CR, Mack M, et al. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2016;374(17):1609-1620.
3. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019;380(18):1695-1705.