Author + information
- Oliver Husser,
- Won-Keun Kim,
- Costanza Pellegrini,
- Andreas Holzamer,
- Thomas Walther,
- Patrick N. Mayr,
- Michael Joner,
- Albert M. Kasel,
- Jonathan Michel,
- Tobias Andreas Rheude,
- Adnan Kastrati,
- Heribert Schunkert,
- Christof Burgdorf,
- Michael Hilker,
- Helge Möllmann and
- Christian Hengstenberg
Background: Data on the clinical performance of the novel self-expanding transfemoral Symetis ACURATE neo (NEO) is limited and no comparative data exist versus the balloon-expandable Edwards SAPIEN 3 (S3). We report a multicenter clinical experience with NEO and performed a propensity-matched comparison with S3 with regard to device failure and early safety at 30 days according to the updated valve academic research consortium.
Methods: Between January 2014 and January 2016, 311 patients were treated with NEO and 810 with S3 at 3 high volume centers. A 2-to-1 nearest neighbour matching using baseline clinical, electrocardiographic and anatomical parameters was performed to identify two patients treated with S3 (n=622) for each patient treated with NEO (n=311).
Results: Comparing patients treated with NEO to those with S3, there were no significant differences regarding in-hospital complications, such as stroke (2% vs. 2%; p=0.640), major vascular complications (10% vs. 9%; p=0.376), life-threatening bleeding (4% vs. 4%; p=0.718), or renal failure (3% vs. 3%; p=0.679). Use of NEO was associated with a lower incidence of new permanent pacemaker implantations (10% vs. 16%; p=0.024). The incidence of paravalvular leakage (PVL) II+ was higher with NEO (5% vs. 2%; p=0.008), however elevated gradients (>20 mmHg) were less frequent (3% vs. 7%; p=0.021) resulting in a similar intended performance (90% vs. 91%; p=0.753). Postprocedural mean transvalvular gradients were lower with NEO (9±5 vs. 12±5 mmHg; p<0.001). Device failure was comparable between NEO and S3 (11% vs. 10%; OR 1.149 95%CI [0.737-1.793]; p=0.539). At 30 days, all-cause mortality was 2% for both, NEO and S3 (p=0.749). Use of NEO resulted in comparable rates of the composite early safety endpoint at 30 days compared to S3 (16% vs. 16%, HR 1.009 95%CI [0.716-1.423]; p=0.959).
Conclusions: Both NEO and S3 showed good clinical results with comparable, low rates of device failure and of the composite early safety endpoint at 30 days. NEO was associated with a lower rate of new permanent pacemaker implantations and elevated gradients while the rate of PVL II+ was higher compared to S3.
Poster Contributions 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: 1243-167
- 2017 American College of Cardiology Foundation