Abstract 15952: Feasibility and Safety of Balloon Expandable Transcatheter Aortic Valve Implantation With Moderate or No Predilatation
Background: Aortic valve preparation by performing balloon aortic valvuloplasty (BAV) has so far been considered mandatory during transcatheter aortic valve replacement (TAVR) procedures. We hypothesized that performing TAVR without predilatation (PD) could potentially reduce BAV complications during TAVR (e.g. stroke or conduction disorders), while yielding similar hemodynamic and clinical outcome. There is limited data on the safety of TAVR with moderate or with no PD and previous publications addressing this issue are mainly of self-expandable valves.
Methods & Results: Between September 2012 and January 2014, 95 patients underwent direct balloon expandable TAVR (no PD group) and 255 patients had moderate PD before valve deployment (mean balloon width-15mm; moderate PD group). The Transfemoral approach was used in 79% of patients. Device success was similar between groups (no PD -97%, moderate PD -95%; p=0.44), post procedural mean aortic valve gradients were 6.8 and 6mmHG. There was significantly less initial perivalvular leak (PVL) in the no PD group: 82%, 17%, 1%, 0% versus 66%, 23%, 9%, 2% for no/trace, mild, moderate and severe PVL respectively (p<0.01). Postdilatation was performed in 5.3% of the patients in the no PD group compared to 8.2% in the moderate PD group (p=0.34). Thirty-day mortality and stroke rates were 2.1% and 2.1% in the no PD group compared to 3.5 and 2.4 in the moderate PD group (Table). Fewer permanent pacemaker implantations were needed in the no PD group (2.1% vs. 7.8%; p=0.048). All other in-hospital complications were similar between groups.
Conclusions: TAVR with moderate or no PD is feasible and safe. The no PD approach was associated with lower rates of permanent pacemaker implantation and less PVL without affecting procedural success.
Author Disclosures: Y. Abramowitz: None. H. Jilaihawi: Consultant/Advisory Board; Modest; Edwards Lifesciences Corporation, St. Jude Medical, Venus MedTech. T. Chakravarty: None. M. Nakamura: None. W. Cheng: None. A. Dhoble: None. J. Castellanos: None. M. Kashif: None. N. Takahashi: None. N. Doctor: None. M. Gheorghiu: None. R.R. Makkar: Research Grant; Modest; Edwards Lifesciences Corporation, St. Jude Medical. Consultant/Advisory Board; Modest; Abbott Vascular, Cordis, Medtronic.
- © 2014 by American Heart Association, Inc.