Author + information
- Conrad Macon,
- Joel Lardizabal,
- Brian O'Neill,
- Claudia Martinez,
- Carlos Alfonso,
- Donald Williams,
- William O'Neill and
- Alan Heldman
The Edwards SAPIEN valve with its Retroflex delivery system was the first FDA–approved device for transcatheter aortic valve replacement (TAVR) in the US for inoperable patients with severe aortic stenosis (AS) via retrograde transfemoral (TF) approach. In patients who were ineligible for TF access because of insufficient iliofemoral vessels, TAVR with the device was performed using alternative access routes (off–label use) in our site. We report early outcomes after TAVR for on– & off–label indications in our clinical TAVR program.
Between 12/2011 & 06/2012, we performed TAVR on 114 consecutive patients with severe AS who were deemed inoperable. We compared procedural & 30–day clinical outcomes in 54 patients who underwent TF TAVR (on–label group) & 60 patients with other access sites (off–label group), including transaortic (n=44), transapical (n=10), & antegrade transseptal (n=6) approaches.
Both groups had similar rates of procedural adverse events & 30–day clinical outcomes. These event rates were comparable with published clinical trial & registry data. On–label TAVR was associated with shorter hospital stay & a nonsignificant trend towards lower all–cause mortality.
Our early efficacy outcomes for clinical TAVR appear favorable for both on– and off–label use of the commercially–available device. Non–TF access strategies have allowed treatment for AS patients who otherwise would have no option for valve replacement.
Poster Sessions, Expo North
Saturday, March 09, 2013, 3:45 p.m.–4:30 p.m.
Session Title: Valvular Heart Disease: Clinical III – Aortic Valve Stenosis
Abstract Category: 31. Valvular Heart Disease: Clinical
Presentation Number: 1155–81
- 2013 American College of Cardiology Foundation