Journal
JACC-CARDIOVASCULAR INTERVENTIONS
Volume 7, Issue 7, Pages 781-789Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jcin.2014.02.013
Keywords
aortic stenosis; paravalvular regurgitation; post-dilation; prosthesis-patient mismatch; reballooning; transcatheter aortic valve replacement
Categories
Funding
- Philips Healthcare
- Edwards Lifesciences
- Boston Scientific Corporation
- AstraZeneca
- Bristol Myers Squibb
- Daiichi-Sankyo/Eli Lilly
- GlaxoSmithKline
- Janssen
- Merck/Schering-Plough
- Regeneron
- St. Jude Medical
- Abbott Vascular
- Medtronic
- Siemens
- Paieon
- Cordis
- MicroInterventional Devices
- Lantheus Medical Imaging
- GE Healthcare
- Boston Scientific
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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. (J Am Coll Cardiol Intv 2014; 7: 781-9) (C) 2014 by the American College of Cardiology Foundation
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