Outcomes with post-dilation following transcatheter aortic valve replacement : the PARTNER 1 trial (placement of aortic transcatheter valve).

Authors: Hahn, Rebecca T.; Pibarot, Philippe; Webb, John; Rodés-Cabau, Josep; Herrmann, Howard C.; Williams, Mathew; Makkar, Raj; Szeto, Wilson Y.; Main, Michael L.; Thourani, Vinod H.; Tuzcu, Murat; Kapadia, Samir; Akin, Jodi; McAndrew, Thomas; Xu, Ke; Leon, Martin B.; Kodali, Susheel
Abstract: Objectives: This study sought to characterize the patients receiving post-implantation balloon dilation (PD) following transcatheter aortic valve replacement (TAVR) and evaluate procedural outcomes in the PARTNER (Placement of Aortic Transcatheter Valve) I trial. Background: Following TAVR, PD has been used to treat paravalvular regurgitation. Methods: The PARTNER I trial cohort A (n = 304) and cohort B (n = 194) patients randomized to TAVR and the nonrandomized continued access TAVR (n = 1,637) patients were included in the analysis. PD was performed at the discretion of the operator. Clinical events and echocardiographic variables were collected prospectively out to 1 year. Results: The overall incidence of PD was 12.4%. PD patients had significantly less prosthesis-patient mismatch (p < 0.001) and larger effective orifice areas (p < 0.001) throughout the follow-up period. There were significantly more subacute strokes (occurring <7 days: 4.9% vs. 2.6%; p = 0.04) in PD patients but no difference in late stroke, either at 7 to 30 days (0.0% vs. 0.8%; p = 0.16) or >30 days (1.9 vs. 1.7%; p = 0.75). Although there was no significant increase in early mortality with PD, at 1 year, there was a trend for higher all-cause mortality (p = 0.054) and a significant difference in death or stroke (p = 0.04). When the subgroup of patients with none/trace paravalvular regurgitation were evaluated, there was no significant association of PD with mortality (p = 0.61) and death or stroke (p = 0.96). Multivariable analysis failed to show a relationship between PD and mortality. Conclusions: PD is associated with reduced rates of moderate or severe prosthesis-patient mismatch with no evidence for short-term structural deterioration of the balloon-expandable transcatheter valve. Although PD is associated with a greater incidence of early stroke, there is no significant association between PD and stroke beyond 7 days. Multivariable analysis shows no significant association between PD and mortality.
Document Type: Article de recherche
Issue Date: July 2014
Open Access Date: Restricted access
Document version: VoR
Permalink: http://hdl.handle.net/20.500.11794/7288
This document was published in: JACC. Cardiovascular interventions, Vol. 7 (7), 781-789 (2014)
http://dx.doi.org/10.1016/j.jcin.2014.02.013
American College of Cardiology Foundation
Alternative version: 10.1016/j.jcin.2014.02.013
http://www.ncbi.nlm.nih.gov/pubmed/25060022
Collection:Articles publiés dans des revues avec comité de lecture

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