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5-Year Outcomes of Self-Expanding Transcatheter Versus Surgical Aortic Valve Replacement in High-Risk Patients
Thomas G Gleason1, Michael J Reardon2, Jeffrey J Popma3
1Departments of Cardiothoracic Surgery and Cardiology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
Insights
Transcatheter aortic valve replacement (TAVR) demonstrated similar 5-year survival and stroke rates compared to surgical aortic valve replacement (SAVR) in high-risk patients. Both procedures showed low rates of structural valve deterioration and reintervention.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Cardiac Surgery
Background:
- The CoreValve U.S. Pivotal High Risk Trial was the first randomized trial to establish transcatheter aortic valve replacement (TAVR) superiority in 1-year mortality over surgical aortic valve replacement (SAVR) for high-risk patients.
- Mid-term outcomes for TAVR versus SAVR in this population were previously less defined.
Purpose of the Study:
- To compare the safety, performance, and durability of TAVR versus SAVR at a mid-term 5-year follow-up.
- To evaluate long-term clinical and valve-related outcomes in high-risk patients undergoing aortic valve replacement.
Main Methods:
- A randomized controlled trial comparing TAVR with a self-expanding bioprosthesis to SAVR in high-risk surgical patients.
- Follow-up was conducted for 5 years, with outcomes assessed using Valve Academic Research Consortium I (VARC-1) definitions.
- Severe structural valve deterioration was defined by specific hemodynamic criteria (mean gradient ≥40 mm Hg or change ≥20 mm Hg) or new severe aortic regurgitation.
Main Results:
- At 5 years, all-cause mortality was similar between TAVR (55.3%) and SAVR (55.4%).
- Major stroke rates were comparable: 12.3% for TAVR and 13.2% for SAVR.
- Freedom from severe structural valve deterioration was high for both TAVR (99.2%) and SAVR (98.3%), with significantly lower rates of valve reintervention for TAVR (97.0%) compared to SAVR (98.9%).
- Permanent pacemaker implantation was more frequent after TAVR (33.0%) than SAVR (19.8%).
Conclusions:
- Transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) show similar mid-term survival and stroke rates in high-risk patients.
- Severe structural valve deterioration and the need for valve reintervention are infrequent with both TAVR and SAVR at 5 years.
- The findings support TAVR as a viable option for high-risk patients needing aortic valve replacement, with considerations for pacemaker implantation rates.
Background:
The CoreValve U.S. Pivotal High Risk Trial was the first randomized trial to show superior 1-year mortality of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) among high operative mortality-risk patients.
Objectives:
The authors sought to compare TAVR to SAVR for mid-term 5-year outcomes of safety, performance, and durability.
Methods:
Surgical high-risk patients were randomized (1:1) to TAVR with the self-expanding bioprosthesis or SAVR. VARC-1 (Valve Academic Research Consortium I) definitions were applied. Severe hemodynamic structural valve deterioration was defined as a mean gradient ≥40 mm Hg or a change in gradient ≥20 mm Hg or new severe aortic regurgitation. Five-year follow-up was planned.
Results:
A total of 797 patients were randomized at 45 U.S. centers, of whom 750 underwent an attempted implant (TAVR = 391, SAVR = 359). The overall mean age was 83 years, and the STS score was 7.4%. All-cause mortality rates at 5 years were 55.3% for TAVR and 55.4% for SAVR. Subgroup analysis showed no differences in mortality. Major stroke rates were 12.3% for TAVR and 13.2% for SAVR. Mean aortic valve gradients were 7.1 ± 3.6 mm Hg for TAVR and 10.9 ± 5.7 mm Hg for SAVR. No clinically significant valve thrombosis was observed. Freedom from severe SVD was 99.2% for TAVR and 98.3% for SAVR (p = 0.32), and freedom from valve reintervention was 97.0% for TAVR and 98.9% for SAVR (p = 0.04). A permanent pacemaker was implanted in 33.0% of TAVR and 19.8% of SAVR patients at 5 years.
Conclusions:
This study shows similar mid-term survival and stroke rates in high-risk patients following TAVR or SAVR. Severe structural valve deterioration and valve reinterventions were uncommon. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).
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