Balloon Post-Dilation Following Implantation of a Self-Expanding Transcatheter Aortic Valve Bioprosthesis.
(Clinical Trial;Journal Article)
OBJECTIVES: This study sought to explore the impact of balloon post-dilation (BPD) on outcomes in the CoreValve US Clinical Trials. BACKGROUND: BPD following transcatheter aortic valve replacement (TAVR) has been used in selected cases to optimize hemodynamic results. METHODS: Procedural details of 3,532 patients were examined to determine whether BPD was performed after self-expanding TAVR. "Best practice" guidelines recommended BPD for treatment of suboptimal intraprocedural valve function, primarily manifested by moderate or severe residual aortic regurgitation (AR). RESULTS: Procedural BPD was performed in 782 patients (22%) patients. The most common (58.1%) indication was greater than or equal to moderate AR following valve deployment. Greater baseline aortic valve gradients (p < 0.001), higher grades of baseline AR (p < 0.001), larger annular diameters (p < 0.001), and lower device to annular ratios (p < 0.001) were more common in patients who underwent BPD. BPD was performed less often with the 26-mm valve (17.9%) compared to the 31 mm (38.1%) (p < 0.05). BPD reduced moderate or severe AR by 75.6% from 58.1% to 14.2%. Thirty-day and 1-year clinical events were similar in the 2 groups, although acute kidney injury was more common in patients undergoing BPD (p = 0.026). In-hospital major adverse cardiovascular and cerebrovascular event rates were 9.3% in the BPD group versus 7.5% for others (p = NS). There was no increase in neurological events. CONCLUSIONS: BPD of the self-expanding bioprosthesis was performed in 22% of patients in the CoreValve US Clinical Trials most commonly to reduce the degree of residual AR. BPD was effective in acutely improving valve performance without an associated increase in neurologic events. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902; Safety and Efficacy Continued Access Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve Replacement; NCT01531374).
Harrison, JK; Hughes, GC; Reardon, MJ; Stoler, R; Grayburn, P; Hebeler, R; Liu, D; Chang, Y; Popma, JJ; CoreValve US Clinical Investigators,
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