Author + information
- Ganesh Manoharan1,
- Eberhard Grube2,
- Nicolas Van Mieghem3,
- Johan Bosmans4,
- Thomas Modine5,
- Sabine Bleiziffer6,
- Axel Linke7,
- Werner Scholtz8 and
- Stephan Windecker9
- 1Royal Victoria Hospital, Belfast, United Kingdom
- 2University Hospital Bonn, Bonn, Germany
- 3Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands
- 4University Hospital Antwerp, Antwerp, Belgium
- 5Lille University Hospital, Lille, France
- 6German Heart Center Munich, Munich, Germany
- 7University of Leipzig Heart Center, Leipzig, Germany
- 8Heart- and Diabetes Centre NRW Cardiology, Bad Oeynhausen, Germany
- 9University Hospital Bern, Bern, Switzerland
The FORWARD Study is the largest international study (n=1038) to evaluate the Evolut R TAV System (Medtronic, Minneapolis, MN), a next-generation self-expanding, repositionable, supraannular valve in a conformable Nitinol frame, in routine practice. More than mild paravalvular leak (PVL) was only present in 2.0% of patients at discharge. Both implant depth and fit (sizing ratio) can affect PVL rates and pacemaker rates. We examined the incidence of PVL and new pacemaker implantation based on the manufacturer’s recommended implant depth.
Patients with symptomatic aortic stenosis at increased surgical risk underwent attempted implant of the Evolut R TAV system (23-, 26-, 29-mm) at 53 centers on 4 continents. The recommended implant depth is 3–5 mm below the annular plane. Final depth of the LCC and NCC were measured by fluoroscopy and site-reported. The severity of PVL was centrally analyzed by an independent echocardiographic core laboratory (Mayo Clinic).
At baseline, the mean age was 81.8±6.2 years, 64.9% women and the mean STS score was 5.5±4.5%. Nearly all patients (98.0%) were treated via iliofemoral access. Data based on final average implant depth are shown in Table. More than mild PVL at discharge was lowest in patients implanted at the recommended implant depth and the use of the resheathing/recapturing features was similar. Additional data on sizing by depth will be presented.
|%||<3 mm n=109||3-5 mm n=294||>5 mm n=303|
|Moderate/severe LVOT calcification||21.3||18.1||17.8|
|Mild or greater discharge PVL||30.3||32.3||36.3|
|Moderate or greater discharge PVL||2.2||0.8||1.6|
*At 30 days excluding baseline pacemaker or implantable cardioverter defibrillator. LCC, left coronary cusp; LVOT, left ventricular outflow tract; NCC, non-coronary cusp.
New pacemaker rates were positively affected by shallower implant depths; however, nearly all patients had ≤mild PVL at the optimal implant depth of 3 to 5 mm.
STRUCTURAL: Valvular Disease: Aortic