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SAPIEN 3 TAVR in Extremely Large Annuli
Study Questions:
What factors determine paravalvular regurgitation following transcatheter aortic valve replacement (TAVR) in patients with very large annuli?
Methods:
This study examined outcomes in 74 patients from 16 sites with severe symptomatic aortic stenosis treated with a 29 mm Edwards SAPIEN 3 TAVR device (Edwards Lifesciences Corporation, Irvine, CA), where the annular area was above the maximum value recommended by the manufacturer (>683 mm2). Patient data were prospectively collected in the American College of Cardiology/Society of Thoracic Surgeons (STS) US Transcatheter Valve Therapy (TVT) registry, and procedural findings were reported.
Results:
Mean STS predicted risk of mortality was 5.5 ± 3.5%. Mean age was 77 ± 10 years, and 96% were male. A transfemoral approach was used in 95% of individuals. The procedure was considered successful in all cases, with two deaths, one stroke, two major vascular complications, and four new permanent pacemaker implantations at 1 month. At least mild paravalvular regurgitation at 1 month was seen in 22 cases (30%), with moderate regurgitation seen in three patients, and no cases of severe regurgitation. Variables associated with ≥ mild regurgitation included increased maximal annular or left ventricular outflow tract (LVOT) diameter, increased LVOT area and perimeter, and a LVOT area larger than the annulus area (p < 0.05 for each). Calcification characteristics were not associated with increased aortic regurgitation.
Conclusions:
The use of a balloon-expandable TAVR device in selected patients with annulus dimensions above manufacturer recommendations was associated with a low rate of adverse events at 1 month.
Perspective:
This study examined a selected cohort of patients from multiple sites who underwent TAVR despite an annular size above manufacturer recommendations for the 29 mm SAPIEN 3 device. There is no comparison group, and selection bias is likely present. As this is a retrospective registry study, details on patient selection are limited. Given these limitations, the rate of adverse events at 30 days was low, although 30% had at least mild paravalvular aortic regurgitation. Patterns of calcification were not associated with the presence of regurgitation, although larger annular and LVOT sizes were logically associated with increased regurgitation. Further, an annular area smaller than the LVOT area was associated with increased regurgitation potentially due to a shorter seal zone. While this study demonstrates the feasibility of this approach, the long-term durability of the devices in these patients is not known, and it would be preferable to have larger devices designed for those with very large annuli. Caution should be used in applying these findings until more robust and long-term data are available.
Keywords: Aortic Valve Insufficiency, Aortic Valve Stenosis, Calcification, Physiologic, Cardiac Surgical Procedures, Heart Valve Diseases, Heart Valve Prosthesis, Pacemaker, Artificial, Stroke, STS/ACC TVT Registry, Transcatheter Aortic Valve Replacement
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