Journal article
Valve-in-Surgical-Valve With SAPIEN 3 for Transcatheter Aortic Valve Replacement Based on Society of Thoracic Surgeons Predicted Risk of Mortality
Circulation. Cardiovascular interventions, v 14(5), pp 503-512
01 May 2021
PMID: 34003666
Featured in Collection : UN Sustainable Development Goals @ Drexel
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.
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Details
- Title
- Valve-in-Surgical-Valve With SAPIEN 3 for Transcatheter Aortic Valve Replacement Based on Society of Thoracic Surgeons Predicted Risk of Mortality
- Creators
- Tsuyoshi Kaneko - Brigham and Women's HospitalRaj R. Makkar - Cedars-Sinai Medical CenterAmar Krishnaswami - Cleveland Clin, Div Cardiol, Cleveland, OH 44106 USAJames Hermiller - Heart Ctr Indiana, Indianapolis, IN USAAdam Greenbaum - University Medical CenterVasilis Babaliaros - University Medical CenterPinak B. Shah - Brigham and Women's HospitalStephen H. Bailey - Allegheny General HospitalVinnie Bapat - Minneapolis Heart Institute FoundationSamir Kapadia - Cleveland ClinicAmr E. Abbas - Minneapolis Heart Institute Foundation
- Publication Details
- Circulation. Cardiovascular interventions, v 14(5), pp 503-512
- Publisher
- Lippincott Williams & Wilkins
- Number of pages
- 10
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Cardiothoracic Surgery
- Web of Science ID
- WOS:000651573900008
- Scopus ID
- 2-s2.0-85106194259
- Other Identifier
- 991021960653604721
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- Collaboration types
- Domestic collaboration
- Web of Science research areas
- Cardiac & Cardiovascular Systems