Outcomes With Post-Dilation Following Transcatheter Aortic Valve Replacement: The PARTNER I Trial (Placement of Aortic Transcatheter Valve)

Abstract

This study sought to characterize the patients receiving post-implantation balloon dilation (PD) following transcatheter aortic valve replacement (TAVR) and evaluate procedural outcomes in thePARTNER (Placement of Aortic Transcatheter Valve) I trial. Following TAVR, PD has been used to treat paravalvular regurgitation. 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. 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>30days (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 andmortality. 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.