Mechanically expanding TAVR system effective in bicuspid valves

A mechanically expanding transcatheter aortic valve performed similarly in patients with bicuspid valves compared with those with tricuspid valves, according to 2-year data from the RESPOND study presented at EuroPCR.

The prospective, open-label RESPOND study included 996 patients with severe aortic stenosis treated with the mechanically expanding valve (Lotus, Boston Scientific) in real-world settings.

For the present analysis, Daniel J. Blackman, MD, consultant cardiologist at Leeds General Infirmary, Leeds, United Kingdom, and colleagues compared outcomes up to 2 years between the 3.1% of the cohort with bicuspid aortic valves (mean age, 76 years; 65% men) and the remainder of the cohort with tricuspid aortic valves.

Procedural success occurred in 100% of the bicuspid group and 99.8% of the tricuspid group, and in the bicuspid group there were no cases of migration, embolization or deployment of a second valve, according to the researchers.

Aortic valve gradient did not significantly differ between the groups at discharge (bicuspid, 12.38 mm Hg; tricuspid, 10.76 mm Hg; P = .06) or at 1 year (bicuspid, 13.33 mm Hg; tricuspid, 10.67 mm Hg; P = .17).

Mean effective orifice area was also similar between the groups at discharge (bicuspid, 1.64 cm²; tricuspid, 1.81 cm²; P = .05) and at 1 year (bicuspid, 1.62 cm²; tricuspid, 1.79 cm²; P = .1).

No patients in the bicuspid group had moderate or higher paravalvular leak, whereas 13.8% of them had mild paravalvular leak at discharge and 15% had mild paravalvular leak at 1 year. The rates of paravalvular leak did not differ between the groups at discharge (P = .1) or at 1 year (P = .13), the researchers wrote in an abstract.

All-cause mortality did not differ between the groups at 30 days (bicuspid, 3.2%; tricuspid, 2.2%; P = .51), 1 year (bicuspid, 9.7%; tricuspid, 11.7%; P = .74) or 2 years (bicuspid, 16.4%; tricuspid, 19.7%; P = .65), according to Blackman and colleagues.

CV mortality, stroke, hospitalization for valve-related symptoms or worsening congestive HF and pacemaker implantation also did not differ between the groups at 2 years.

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“Data from the RESPOND registry suggest that [transcatheter aortic valve replacement] with the Lotus Valve in patients with bicuspid aortic valve anatomy is associated with a high degree of procedural success, improved hemodynamics and good clinical outcomes through 2 years,” Blackman and colleagues wrote in the abstract. “Given the limited number of bicuspid patients enrolled in RESPOND, these results should be confirmed in a larger study.” – by Erik Swain

Reference:

Blackman DJ, et al. Bicuspid aortic stenosis: From imaging to TAVI. Presented at: EuroPCR; May 21-24, 2019; Paris.

Disclosure: Cardiology Today’s Intervention could not confirm relevant financial disclosures at the time of publication.