New Self-Expanding Valve Measures Up Against Sapien 3

Both balloon-expandable and self-expanding valves have been tested in randomized studies, with excellent outcomes. While both technologies have advantages, the chance to reposition or re-steer the sheath is only offered by self-expanding valves, which also adjust better to patient anatomy.

Nueva válvula autoexpandible se mide con Sapien 3

The CHOICE trial, published in 2014 in JAMA, was one of the few randomized studies comparing both valve types; its outcomes showed balloon-expandable devices as superior. However, this trial used first-generation devices that are no longer available in the market, something that renders it obsolete.


Read also: The SOURCE 3 Confirms the Good Outcomes of the SAPIEN 3 at One Year Followup”.


This new work, recently published in JACC, compared the new self-expanding ACURATE neo (NEO) and the next-generation balloon-expandable SAPIEN 3 (S3). In order to do so, 1121 patients were enrolled; 622 were treated with S3 and 311 were treated with NEO.

 

In-hospital complications were comparable between NEO and S3, including stroke (1.9% vs. 2.4%; p = 0.64), major vascular complications (10.3% vs. 8.5%; p = 0.38), or life-threatening bleeding (4.2% vs. 3.7%; p = 0.72).

 

Device failure was also similar for both prostheses (10.9% vs. 9.6%; p = 0.71), with more paravalvular leak with NEO (moderate to more severe leak, 4.8% vs. 1.8%; p = 0.01), but lower gradient (≥20 mm Hg, 3.2% vs. 6.9%; p = 0.02) and pacemaker implantation rates (9.9% vs. 15.5%; p = 0.02).


Read also: Lotus vs Sapien 3, different mechanisms with similar results”.


Thirty-day mortality and acute device safety rates were similar with both devices. However, a month is definitely too short a time to assess these devices given the current status of transcatheter aortic valve replacement.

 

Conclusion

High technical success and excellent clinical results characterized both valves. Differences found included the fact that the ACURATE neo device was associated with lower pacemaker implantation and lower elevated gradient rates, and the SAPIEN 3 device was associated with lower paravalvular leak rates.

 

Editorial

Both devices include skirts for the reduction of paravalvular leak. In fact, SAPIEN 3 achieved an impressive 1.8% rate of moderate to more severe leak. As a downside, these skirts interact with the left ventricular outflow tract, thus increasing the rates of pacemaker implantation.

 

Original title: Multicenter Comparison of Novel Self-Expanding Versus Balloon-Expandable Transcatheter Heart Valves.

Reference: Oliver Husser et al. J Am Coll Cardiol Intv 2017;10:2078-87.


Subscribe to our weekly newsletter

Get the latest scientific articles on interventional cardiology

We are interested in your opinion. Please, leave your comments, thoughts, questions, etc., below. They will be most welcome.

More articles by this author

TCT 2024 | TRISCEND II

This randomized study included 400 patients; 267 were treated with EVOQUE valve and 133 with optimal medical treatment (OMT). After one-year follow-up, there were no...

TCT 2024 – ACCESS-TAVI: Comparing Percutaneous Access Closure Strategies After TAVI

Vascular access complications following transcatheter aortic valve implantation (TAVI) remain common. However, few studies compare vascular access closure methods.  Based on the CHOICE-CLOSURE and MASH...

TAVR in Young Low-Risk Patients

Transcatheter aortic valve replacement (TAVR) has established itself as an effective strategy for the treatment of severe aortic stenosis across different risk groups. While previous...

TAVR and Atrial Fibrillation: What Anticoagulants Should We Use?

The prevalence of atrial fibrillation (AF) in TAVR patients ranges from 15 to 30%, depending on series. This arrhythmia has been associated to higher...

LEAVE A REPLY

Please enter your comment!
Please enter your name here

Related Articles

SOLACI Sessionsspot_img

Recent Articles

TCT 2024 | FAVOR III EUROPA

The study FAVOR III EUROPA, a randomized trial, included 2,000 patients with chronic coronary syndrome, or stabilized acute coronary syndrome, and intermediate lesions. 1,008...

TCT 2024 | TRISCEND II

This randomized study included 400 patients; 267 were treated with EVOQUE valve and 133 with optimal medical treatment (OMT). After one-year follow-up, there were no...

TCT 2024 – ACCESS-TAVI: Comparing Percutaneous Access Closure Strategies After TAVI

Vascular access complications following transcatheter aortic valve implantation (TAVI) remain common. However, few studies compare vascular access closure methods.  Based on the CHOICE-CLOSURE and MASH...