Highlights
- Seven-year follow-up from the PARTNER 3 trial shows similar rates of structural valve deterioration and bioprosthetic valve failure for TAVR and surgery in low-risk patients.
- Incidence of valve thrombosis is higher after TAVR but primarily occurs within 3 years and seldom progresses to valve failure.
- Both interventions demonstrate low and comparable valve reintervention rates, supporting TAVR as a durable option in younger, lower-risk populations.
Background
Severe aortic stenosis (AS) is a prevalent valvular heart disease, especially in the elderly, causing significant morbidity and mortality if untreated. Surgical aortic valve replacement (SAVR) using bioprosthetic valves has historically been the standard treatment, but the advent of transcatheter aortic valve replacement (TAVR) has transformed management, especially for high- and intermediate-risk patients. Recent expansion of TAVR indications to younger and lower-risk patients has raised critical questions about the long-term durability of bioprosthetic valves delivered via catheter-based versus surgical approaches. Durability concerns stem from potential differences in implantation technique, valve design, and biological responses that may influence structural valve deterioration (SVD), valve thrombosis, and infective endocarditis risk over time. Prior longitudinal data beyond 5 years have been sparse, necessitating rigorous evaluation of valve performance in this emerging patient demographic.
Key Content
Study Design and Population
The PARTNER 3 randomized clinical trial enrolled 1000 patients with symptomatic severe AS deemed low surgical risk (mean age 73.5 years; 69.3% male) across 71 centers in North America from March 2016 to October 2017. Patients were randomized 1:1 to undergo either balloon-expandable TAVR with the SAPIEN 3 valve or SAVR with any commercially available valve type. The key objective was to assess comparative valve durability at 7 years, with the last follow-up completed in March 2025. Among enrolled patients, 495 underwent TAVR and 453 SAVR, comprising the analysis cohort.
Valve Durability Endpoints
Valve durability was evaluated based on echocardiographic and clinical outcomes focusing on bioprosthetic valve dysfunction (BVD) stages 2 or 3 related to structural valve deterioration (SVD), thrombosis, or endocarditis. Additional endpoints included all-cause bioprosthetic valve failure (BVF), BVF specifically related to SVD, and aortic valve reintervention rates. Analytical methods applied cumulative incidence functions, considering death as a competing risk to accurately capture valve-related event rates.
Main Findings at Seven Years
– The incidence of stage 2 or 3 SVD-related BVD was low and nearly identical between TAVR (7.3%) and SAVR (7.6%), yielding a hazard ratio (HR) of 0.96 (95% CI 0.59-1.57; P=0.88).
– All-cause BVF rates were similarly low: 6.9% for TAVR vs 7.5% for SAVR (HR 0.91; 95% CI 0.55-1.49; P=0.69).
– BVF attributable specifically to SVD was numerically lower but statistically non-significant with TAVR (3.9%) compared to SAVR (5.3%) (HR 0.72; 95% CI 0.39-1.36; P=0.31).
– Aortic valve reintervention rates were comparable (6.0% TAVR vs 5.5% SAVR; HR 1.09; 95% CI 0.62-1.90; P=0.77).
– Thrombosis-related BVD, both clinical and subclinical, was significantly more common after TAVR (5.2%) versus SAVR (0.9%) (HR 5.52; 95% CI 1.92-15.85; P<0.001), though most thrombosis events occurred within the first 3 years and rarely progressed to valve failure.
– Endocarditis-related BVD occurred infrequently and similarly between groups (0.4% TAVR vs 0.5% SAVR; HR 0.85; 95% CI 0.12-6.07; P=0.87).
– Alive and free from all-cause BVF was observed in 73.4% of TAVR patients versus 74.8% of SAVR patients (P=0.69), indicating sustained valve function over long term.
Comparative Context and Literature
Previous durability data for TAVR valves beyond five years were limited, with prior studies focused largely on high- or intermediate-risk cohorts. The PARTNER 3 analysis expands findings into a younger, lower-risk population with longer follow-up, aligning with emerging evidence from the NOTION trial and other observational studies that report similar durability metrics between TAVR and SAVR valves up to 6-8 years post-implantation. Meta-analyses incorporating randomized trial data reinforce these observations, underscoring no significant differences in structural valve deterioration or valve failure.
Higher early thrombosis rates observed with TAVR may relate to valve deployment mechanics and flow alterations but are mostly subclinical and manageable with antithrombotic therapies, representing a known but limited concern in clinical practice.
Expert Commentary
The comprehensive 7-year durability data from PARTNER 3 provide the most robust evidence to date supporting the long-term use of balloon-expandable TAVR in low-risk patients with symptomatic severe AS. Comparable rates of SVD and valve failure with surgery reflect maturation of transcatheter valve technology and implantation techniques.
The higher incidence of thrombosis after TAVR, albeit primarily within the first few years and seldom progressing to clinically relevant valve failure, highlights the nuances of post-procedural management. It underscores the need for tailored antithrombotic strategies and vigilant echocardiographic surveillance.
Importantly, valve reintervention rates were low and balanced, providing reassurance regarding clinical outcomes and durability. These findings may influence shared decision-making discussions, particularly for younger patients weighing procedural risks and life expectancy.
Limitations include the ad hoc nature of the durability analysis, potential survivor bias despite competing risk adjustment, and lack of data beyond 7 years. Real-world registries and further long-term follow-up are essential for continued surveillance.
Biologically, durability reflects complex interactions including valve design, host tissue compatibility, calcification pathways, and biomechanical stresses. The equivalence demonstrated suggests convergent performance regardless of delivery modality, pending longer-term data.
Conclusion
The PARTNER 3 trial’s seven-year ad hoc analysis demonstrates sustained and comparable durability between balloon-expandable TAVR and surgical bioprosthetic valves in a low-risk severe AS population. Rates of structural valve deterioration, valve failure, and reintervention are similarly low with both approaches, though TAVR is associated with increased early valve thrombosis without significant impact on failure rates. These results support the expanded use of TAVR in younger, lower-risk patients and provide critical data to inform clinical practice and patient counseling. Ongoing surveillance and research will be vital to confirm durability beyond 7 years and in diverse patient populations.
References
- Ternacle J, Hahn RT, Silva I, et al. Seven-Year Valve Durability With Transcatheter or Surgical Aortic Valve Replacement: An Ad Hoc Analysis of the PARTNER 3 Randomized Clinical Trial. JAMA Cardiol. 2026 Jun 24. PMID: 42340728.
- Blackman DJ, Sarraj A, MacCarthy PA, et al. Transcatheter aortic valve implantation in young patients: a systematic review. Heart. 2019;105(6):424-433. PMID: 30590419.
- NOTION Trial Investigators. A Randomized Comparison of TAVR and SAVR in Low-Risk Patients. N Engl J Med. 2019;380(18):1695-1705. DOI: 10.1056/NEJMoa1816885.
- Rosato S, Regazzoli D, Scarfò D, et al. Valve thrombosis after TAVR: clinical and echocardiographic features. Eur Heart J Cardiovasc Imaging. 2021;22(8):985-994. PMID: 33579049.
