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. 2021 May;14(5):e010288.
doi: 10.1161/CIRCINTERVENTIONS.120.010288. Epub 2021 May 18.

Valve-in-Surgical-Valve With SAPIEN 3 for Transcatheter Aortic Valve Replacement Based on Society of Thoracic Surgeons Predicted Risk of Mortality

Tsuyoshi Kaneko  1 , Raj R Makkar  2 , Amar Krishnaswami  3 , James Hermiller  4 , Adam Greenbaum  5 , Vasilis Babaliaros  5 , Pinak B Shah  6 , Stephen H Bailey  7 , Vinnie Bapat  8 , Samir Kapadia  4 , Amr E Abbas  8
Affiliations

Valve-in-Surgical-Valve With SAPIEN 3 for Transcatheter Aortic Valve Replacement Based on Society of Thoracic Surgeons Predicted Risk of Mortality

Tsuyoshi Kaneko et al. Circ Cardiovasc Interv. 2021 May.

Erratum in

Abstract

Background: The use of valve-in-valve–transcatheter aortic valve replacement (VIV-TAVR) in degenerated aortic bioprosthesis has been increasing, but the Food and Drug Administration approval is limited to high-risk patients. We analyzed the real-world experience of SAPIEN 3 VIV-TAVR, especially in lower-risk patients, based on the Society of Thoracic Surgeons (STS) score.

Methods: All transfemoral VIV-TAVR with the SAPIEN 3 and Ultra valves between June 2015 and January 2020 were identified using the STS/American College of Cardiology Transcatheter Valve Therapies Registry. Patients were grouped based on STS score (low score: <4%, intermediate score: 4%≤ and≤8%, high score: >8%). Propensity-matched (1:3) analysis was conducted to compare to patients undergoing native TAVR.

Results: Of 145 917 SAPIEN 3 TAVR patients, 4460 (3%) underwent transfemoral VIV-TAVR with available baseline STS data in 4276 patients. Average age was 73.9±11.2, 66.4% were male, and the mean STS score was 6.9±6.0%. Overall 30-day mortality was 2.4% (observed to expected ratio, 0.33), and 1-year mortality was 10.8%. 30-day mortality and observed to expected ratio were 0.9% and 0.32 in low-score, 2.2% and 0.38 in the intermediate-score, and 4.3% and 0.31 in the high-score group. Based on propensity-matched analysis, 30-day mortality was similar and 1-year mortality was lower in VIV compared to native TAVR among all risk groups. When the groups were analyzed based on the Heart Team risk stratification using high-risk and non–high risk, the findings remained consistent.

Conclusions: In this real-world study, VIV-TAVR had excellent 30-day and 1-year outcomes, especially in lower-risk patients. These findings may suggest the feasibility and expansion of VIV-TAVR in lower-risk patients. However, long-term follow-up continues to be crucial.

Keywords: bioprosthetic; mortality; registry; risk; transcatheter aortic valve replacement.

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