Author + information
- Nicolas M. Van Mieghem,
- Jochen Woehrle,
- David Hildick-Smith,
- Sabine Bleiziffer,
- Daniel J. Blackman,
- Mohamed Abdel-Wahab,
- Ulrich Gerckens,
- Axel Linke,
- Hueseyin Ince,
- Peter M. Wenaweser,
- Dominic Allocco,
- Keith Dawkins and
- Volkmar Falk
Background: Balloon valvuloplasty (BAV) has been recommended prior to transcatheter aortic valve replacement (TAVR); however, there has been a trend towards a more simplified approach without BAV in routine clinical practice. Here we examine 30-day outcomes following TAVR performed with or without prior BAV in patients treated with the repositionable and fully retrievable Lotus Valve.
Methods: The prospective, single-arm, RESPOND post-market study enrolled 1014 patients with calcific aortic stenosis from 41 sites in Europe, New Zealand, and Latin America. The primary endpoint was all-cause mortality at 30 days and 1 year post-procedure. Paravalvular aortic regurgitation at baseline and hospital discharge were adjudicated by an independent core laboratory. The decision to use BAV was at the discretion of the operator.
Results: Among 996 patients implanted with a Lotus Valve (mean age, 80.8 yrs; 50.8% female; baseline STS Score, 6.0%), 524 patients had BAV and 449 patients had no BAV (status not recorded, n=23). Patient demographics were similar in both groups. Mean aortic valve gradient at baseline was 39.2 mmHg in the BAV group vs 36.8 mmHg in the no BAV group (P=0.02). Successful vascular access, delivery, and deployment of the Lotus Valve was 99.8% in both groups. At discharge, there was no difference in aortic valve area (BAV: 1.8±0.4 cm2, no BAV: 1.8±0.5 cm2; P=0.76) or mean gradient (BAV: 11.0±4.8 mmHg, no BAV: 10.7±4.2 mmHg; P=0.29). No patients had severe PVL and 0.3% had moderate PVL at discharge; ≥mild PVL occurred in 9.5% and 6.6% of patients with and without BAV, respectively (P=0.11). At 30 days, there were no differences between groups for overall mortality (BAV: 2.1%, no BAV: 2.5%; P=0.71), disabling stroke (BAV: 2.3%, no BAV: 2.0%; P=0.77), or life-threatening/disabling bleeding (BAV: 2.1%, no BAV: 2.5%; P=0.71). The rate of new permanent pacemaker implantation at 30 days was similar in the BAV (31.0%) and no BAV (29.1%) groups (P=0.52).
Conclusions: Clinical outcomes at 30 days were similar for patients in RESPOND regardless of whether BAV was used prior to TAVR. Future studies will continue to evaluate the need for BAV prior to Lotus Valve implantation, and the impact of BAV on clinical outcomes.
Poster Hall, Hall C
Saturday, March 18, 2017, 3:45 p.m.-4:30 p.m.
Session Title: Interventional Cardiology: TAVR 3
Abstract Category: 17. Interventional Cardiology: Aortic Valve Disease
Presentation Number: 1243-170
- 2017 American College of Cardiology Foundation