Rebecca T Hahn1, Philippe Pibarot2, Jonathon Leipsic3, Philipp Blanke3, Pamela S Douglas4, Neil J Weissman5, Samir Kapadia6, Vinod H Thourani5, Howard C Herrmann7, Tamim Nazif8, Thomas McAndrew9, John G Webb3, Martin B Leon8, Susheel Kodali8. 1. Columbia University Medical Center/NY Presbyterian Hospital, New York, New York. Electronic address: rth2@columbia.edu. 2. Department of Medicine, Laval University, Quebec, Quebec, Canada. 3. University of British Columbia and St. Paul's Hospital, Vancouver, British Columbia, Canada. 4. Duke University Medical Center, and Duke Clinical Research Institute, Durham, North Carolina. 5. Georgetown University School of Medicine, Medstar Health Research Institute, Washington, DC. 6. Cleveland Clinic, Cleveland, Ohio. 7. University of Pennsylvania, Philadelphia, Pennsylvania. 8. Columbia University Medical Center/NY Presbyterian Hospital, New York, New York. 9. Cardiovascular Research Foundation, New York, New York.
Abstract
OBJECTIVES: The purpose of this study was to understand the effects of balloon post-dilatation on outcomes following transcatheter aortic valve replacement with the SAPIEN 3 valve. BACKGROUND: Hemodynamics and outcomes with balloon post-dilatation for the SAPIEN 3 valve have not been previously reported. METHODS: The effects of balloon post-dilatation (BPD) in 1,661 intermediate (S3i cohort) and high surgical risk (S3HR cohort) patients with aortic stenosis enrolled in the PARTNER (Placement of Aortic Transcatheter Valves) 2, SAPIEN 3 observational study on outcomes, as well as procedural complications, were assessed. RESULTS: 208 of 1,661 patients (12.5%) had BPD during the initial transcatheter aortic valve replacement. Baseline characteristics were similar except BPD had higher STS score (p < 0.001), significantly less % oversizing (p = 0.004), significantly more ≥moderate left ventricular outflow tract calcification (p = 0.005), and severe annular calcification (p = 0.006). BPD patients had no increase in permanent pacemaker, annular rupture, or valve embolization. Following transcatheter aortic valve replacement, BPD patients had significantly larger aortic valve area (1.72 ± 0.41 cm2 vs. 1.66 ± 0.37 cm2; p = 0.04) with no significant difference in prosthesis-patient mismatch (p = 0.08) or transvalvular aortic regurgitation (p = 0.65), but significantly more paravalvular regurgitation (p < 0.01). There was no significant difference in 30-day or 1-year outcomes of all-cause death (p = 0.65 to 0.76) or stroke (p = 0.28 to 0.72). However, at 1 year, there was a significantly higher incidence of minor stroke in BPD patients (p = 0.02). Adjusting for baseline differences, including calcium burden, minor strokes were no longer significantly different between the BPD and NoBPD groups (p = 0.21). CONCLUSIONS: BPD is performed more frequently in patients with lower % oversizing and greater calcium burden. BPD is not associated with procedural complications or an increase in 1-year adverse events of death, rehospitalization, or stroke.
OBJECTIVES: The purpose of this study was to understand the effects of balloon post-dilatation on outcomes following transcatheter aortic valve replacement with the SAPIEN 3 valve. BACKGROUND: Hemodynamics and outcomes with balloon post-dilatation for the SAPIEN 3 valve have not been previously reported. METHODS: The effects of balloon post-dilatation (BPD) in 1,661 intermediate (S3i cohort) and high surgical risk (S3HR cohort) patients with aortic stenosis enrolled in the PARTNER (Placement of Aortic Transcatheter Valves) 2, SAPIEN 3 observational study on outcomes, as well as procedural complications, were assessed. RESULTS: 208 of 1,661 patients (12.5%) had BPD during the initial transcatheter aortic valve replacement. Baseline characteristics were similar except BPD had higher STS score (p < 0.001), significantly less % oversizing (p = 0.004), significantly more ≥moderate left ventricular outflow tract calcification (p = 0.005), and severe annular calcification (p = 0.006). BPD patients had no increase in permanent pacemaker, annular rupture, or valve embolization. Following transcatheter aortic valve replacement, BPD patients had significantly larger aortic valve area (1.72 ± 0.41 cm2 vs. 1.66 ± 0.37 cm2; p = 0.04) with no significant difference in prosthesis-patient mismatch (p = 0.08) or transvalvular aortic regurgitation (p = 0.65), but significantly more paravalvular regurgitation (p < 0.01). There was no significant difference in 30-day or 1-year outcomes of all-cause death (p = 0.65 to 0.76) or stroke (p = 0.28 to 0.72). However, at 1 year, there was a significantly higher incidence of minor stroke in BPD patients (p = 0.02). Adjusting for baseline differences, including calcium burden, minor strokes were no longer significantly different between the BPD and NoBPD groups (p = 0.21). CONCLUSIONS: BPD is performed more frequently in patients with lower % oversizing and greater calcium burden. BPD is not associated with procedural complications or an increase in 1-year adverse events of death, rehospitalization, or stroke.
Authors: Stephan Haussig; Constantin Pleissner; Norman Mangner; Felix Woitek; Marion Zimmer; Philipp Kiefer; Florian Schlotter; Georg Stachel; Sergey Leontyev; David Holzhey; Michael A Borger; Axel Linke Journal: CJC Open Date: 2021-02-01