The Effect of Post-Dilatation on Outcomes in the PARTNER 2 SAPIEN 3 Registry.

MedStar author(s):
Citation: Jacc: Cardiovascular Interventions. 2018 Aug 07PMID: 30121276Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleYear: 2018Local holdings: Available online through MWHC library: 2008 - presentISSN:
  • 1936-8798
Name of journal: JACC. Cardiovascular interventionsAbstract: BACKGROUND: Hemodynamics and outcomes with balloon post-dilatation for the SAPIEN 3 valve have not been previously reported.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.Copyright (c) 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.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) II, SAPIEN 3 observational study on outcomes, as well as procedural complications, were assessed.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.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 cm<sup>2</sup> vs. 1.66 +/- 0.37 cm<sup>2</sup>; 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).All authors: Blanke P, Douglas PS, Hahn RT, Herrmann HC, Kapadia S, Kodali S, Leipsic J, Leon MB, McAndrew T, Nazif T, Pibarot P, Thourani VH, Webb JG, Weissman NJFiscal year: FY2019Digital Object Identifier: Date added to catalog: 2018-08-23
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Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 30121276 Available 30121276

Available online through MWHC library: 2008 - present

BACKGROUND: Hemodynamics and outcomes with balloon post-dilatation for the SAPIEN 3 valve have not been previously reported.

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.

Copyright (c) 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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) II, SAPIEN 3 observational study on outcomes, as well as procedural complications, were assessed.

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.

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 cm<sup>2</sup> vs. 1.66 +/- 0.37 cm<sup>2</sup>; 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).

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