Seven-Year SAPIEN 3 Clinical Outcomes Reaffirm Long-term Valve Durability and Patient Benefits Over Extended Follow-up

Edwards Lifesciences has unveiled comprehensive seven-year follow-up data from the landmark PARTNER 3 trial, demonstrating that TAVR (transcatheter aortic valve replacement) using the SAPIEN 3 valve maintains durable performance comparable to surgical valve replacement (SAVR) when assessed over an extended timeframe. The findings were presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference and concurrently published in The New England Journal of Medicine.

Long-term Valve Performance Shows Parity With Surgery

The seven-year analysis represents the most comprehensive clinical follow-up available for low-risk patients undergoing either TAVR or surgical aortic valve replacement. Notably, SAPIEN 3 demonstrated clinical superiority at the one-year mark, while sustaining excellent valve performance through the seven-year evaluation period.

Key performance metrics revealed striking similarity between the two treatment approaches:

• Bioprosthetic valve failure rates remained nearly identical (6.9% for TAVR versus 7.3% for surgical intervention)
• Reintervention rates showed comparable outcomes (6.0% versus 6.7%)
• All-cause mortality and cardiovascular mortality rates were statistically equivalent between cohorts
• Valve durability indicators remained stable and robust throughout the follow-up period

These findings effectively challenge earlier assumptions about potential differences in long-term device performance, positioning TAVR as a durable alternative even when matched against traditional surgical approaches over extended observation intervals.

Sustained Quality-of-Life Improvements Across Both Therapies

Beyond structural valve durability, the PARTNER 3 seven-year data documented sustained improvements in patient health status and quality of life measures for both treatment modalities. This consistency in functional outcomes over seven years suggests that early benefits observed at one year are neither temporary phenomena nor subject to deterioration in later phases.

“The PARTNER trial series fundamentally addressed whether TAVR could serve as a viable, less invasive substitute for surgery,” explained Martin Leon, M.D., co-principal investigator and professor of medicine at New York-Presbyterian Columbia University Irving Medical Center. “We now see that early clinical advantages of SAPIEN 3 TAVR persist alongside exceptional long-term durability for both approaches—a finding that should provide substantial reassurance to both patients and clinical practitioners.”

Reinforcing Evidence From a Decade of Research

Parallel presentation of ten-year data from the PARTNER 2 and PARTNER 2 S3i trials, encompassing more than 3,000 intermediate-risk patients, further corroborates the sustained clinical effectiveness of Edwards’ TAVR platform. This decade-spanning body of evidence from the PARTNER trial series collectively demonstrates that hemodynamic stability, freedom from major valve-related complications, and consistent patient outcomes persist well beyond traditional follow-up periods.

Clinical Implications and Global Impact

Since its introduction over twenty years ago, the SAPIEN valve platform has become the most rigorously studied transcatheter valve system, with clinical application in more than 1 million patient cases worldwide. Dan Lippis, corporate vice president for transcatheter aortic valve replacement, emphasized that these latest findings validate the durability narrative: “The PARTNER dataset unequivocally demonstrates early clinical benefits coupled with validated long-term durability equivalent to surgical benchmarks. As the leading innovator in transcatheter valve therapy globally, Edwards remains committed to expanding evidence in aortic valve disease management—encompassing symptomatic severe stenosis, asymptomatic severe disease, and moderate stenosis categories—to advance patient outcomes on a worldwide scale.”

The convergence of seven-year and ten-year efficacy data establishes a compelling foundation for TAVR’s continued expansion into lower-risk and broader patient populations, positioning transcatheter valve replacement as a genuinely durable therapeutic option rather than a temporary solution requiring eventual surgical conversion.