By Marilynn Larkin
NEW YORK (Reuters Health) - Low-surgical risk patients with bicuspid aortic valve stenosis experienced favorable 30-day results with transcatheter aortic valve replacement (TAVR) in a single-arm trial.
"The findings of this prospective study further support retrospective transcatheter valve therapy data which have shown that TAVR in patients with bicuspid aortic valve disease yields favorable results," Dr. John Forrest of Yale University School of Medicine told Reuters Health by email. "In this study, 10% of patients had a Sievers Type 0 bicuspid valve and the remaining had a Type I. Notably, both groups did very well with respect to valve performance, hemodynamics, and paravalvular leak."
As reported in JAMA Cardiology, Dr. Forrest and colleagues analyzed 30-day outcome data from the Low-Risk Bicuspid Study, which has a planned follow-up of 10 years. Eligible patients had severe bicuspid aortic valve stenosis and met American Heart Association/American College of Cardiology guidelines for aortic valve replacement.
Patients underwent attempted implant of an Evolut or Evolut PRO self-expanding, surpra-annular transcatheter aortic valve, with valve size based on annular measurements. The prespecified primary efficacy end point was device success, defined as lack of procedural mortality, one bioprosthetic heart valve correctly positioned in the proper anatomical location, and the no more than mild aortic regurgitation after the procedure.
One hundred and fifty patients (mean age, 70; 48% women; mean Society of Thoracic Surgeons score, 1.4) participated. As Dr. Forrest indicated, most (90.7%) had Sievers type I valve morphology.
At 30 days, the incidence of all-cause mortality or disabling stroke was 1.3% and the device success rate was 95.3%. The mean aortic valve gradient was 7.6 mm Hg and effective orifice area was 2.3 cm2.
With respect to quality of life at 30 days, 110 patients (75.3%) had New York Heart Association class I symptoms, 32 (21.9%) had class II, and four (2.7%) had class III; 121 (82.3%) experienced improvement of at least one class. The mean Kansas City Cardiomyopathy Questionnaire overall summary score was 90.3, up from 68.5 at baseline.
A new permanent pacemaker was implanted in 22 patients (15.1%). None had greater than mild paravalvular leak.
Dr. Ibrahim Sultan, Director, UPMC Center for Thoracic Aortic Disease and Surgical Director, UPMC Center for Transcatheter Aortic Valve Therapies, commented in an email to Reuters Health, "This study adds to the body of work that TAVR is safe and effective in the short term for patients with bicuspid aortic valve undergoing TAVR."
Nonetheless, he noted, "When we perform a valve replacement with a bioprosthesis, we like to assure patients that the average life span of the valve will be about 13 years. This is a big question. We will know with time if these valves will function similarly to surgical valves in 10-15 years."
Also, he said, "these procedures were all done by large, experienced centers. These data may not apply to most centers, as the rate of stroke and death may be higher at less experienced centers. Further, most patients had Sievers 1 anatomy, with only 14 patients being Sievers 0. These anatomic considerations are important in these patients."
"I think patients with bicuspid aortic valve can be considered for TAVR," he said. "However, it is critical to understand some anatomic considerations, which include any degree of aortopathy, height of the fused cusp, size of the sinuses of Valsalva, coronary height and degree of calcification in the left ventricular outflow tract. All of these pointers help us determine if patients with bicuspid aortic valves are good candidates for TAVR."
The Low-Risk Bicuspid Study was funded by Medtronic. Dr. Forrest and eight coauthors have received fees from the company.
SOURCE: https://bit.ly/2H67cdA JAMA Cardiology, online October 7, 2020.