Outcomes After TAVR Using Self-Expanding Bioprosthesis

Study Questions:

What is the early safety and efficacy of a new generation of self-expanding transcatheter aortic valve replacement (TAVR) in treatment of severe aortic stenosis?

Methods:

This study evaluated outcomes in 241 patients with severe aortic stenosis treated with a new generation of self-expanding TAVR device (Evolut R, Medtronic), who were considered at least high risk for surgical valve replacement. Clinical outcomes at 30 days and echocardiographic findings were evaluated.

Results:

Mean age was 83.3 ± 7.4 years, and 68.5% were female. Mean Society of Thoracic Surgeons score was 7.4 ± 3.4. Post-implant balloon dilatation was performed in 33.2%, while resheathing or recapturing of the valve was done in 22.6% of individuals. A mean gradient <20 mm Hg or peak velocity <3 m/sec was observed in 99.1%, and absence of moderate or severe aortic regurgitation was noted in 96.5% of patients. At 30 days, mortality, stroke/transient ischemic attack, vascular access complications, bleeding complications, and need for new pacemaker were 2.5%, 5.9%, 14.5%, 14.5%, and 16.4%, respectively. At 30 days, 83.7% of patients had improvement in heart failure symptoms.

Conclusions:

This new generation of self-expandable TAVR device appears safe and effective for treatment of severe aortic stenosis in patients who would be suboptimal for surgery.

Perspective:

This next generation of self-expandable TAVR includes a 14-F equivalent delivery system, a modified design with optimized radial force at the annulus, a longer sealing skirt, and a new catheter that permits resheathing/recapturing and redeployment of the valve. While no direct comparison is available for this single-arm study, we can compare these results to the results of prior self-expandable TAVR devices in similar patient cohorts. In comparison to prior studies, the rate of at least moderate aortic regurgitation appears lower, which may relate to the device redesign and the ability to resheath/recapture and redeploy the valve. Further, the new smaller sheath size may permit iliofemoral access in some patients with small iliofemoral arteries who would have needed an alternate approach with prior device generations. The need for a permanent pacemaker remains a relatively common complication from this procedure. These results suggest that this new generation of self-expandable device has continued incremental improvements over prior generations.


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