Novel mitral valve replacement system successfully treats mitral regurgitation
Click Here to Manage Email Alerts
Mitral valve replacement using a novel transfemoral implantation system was successful in patients with severe mitral regurgitation at high surgical risk, according to findings presented at the virtual TCT Connect.
Among the first three patients treated with the device (Cephea transcatheter mitral valve implantation, Abbott), there were no events reported at 30 days. At 6 months, all patients survived and improved to NYHA class II HF.
“The confirmation of these initial results, including a larger number of patients, could potentially open the door to a new therapeutic alternative in patients with severe mitral regurgitation, most likely including those with mitral annular calcification features,” Alberto Alperi, MD, of the Quebec Heart and Lung Institute at Laval University, Quebec City, and colleagues wrote in a simultaneous publication in JACC: Cardiovascular Interventions. “This would represent a major step forward toward the expansion of full transcatheter options for mitral regurgitation patients with a high to prohibitive risk profile.”
The patients (mean age, 79 years) presented with mild to moderate valve stenosis and were all NYHA functional class III.
The primary outcomes were procedural success, periprocedural complications and valve hemodynamic status early and at 6 months.
Researchers reported that valve implantation was successful among all participants, with no procedural complications, and all patients were extubated the same day as the procedure.
One patient experienced a transient episode of acute kidney injury in-hospital, which was resolved without dialysis or filtration, and another had an access-site hematoma, which was managed conservatively.
All patients were discharged on anticoagulation therapy with warfarin for at least 3 months.
There were no cases of hemodynamic instability, according to the study, and no mechanical support was used during any of the implantation procedures.
Investigators noted that postprocedural transvalvular gradients were no greater than 4 mm Hg (mean, 3 mm Hg) and trace or mild paravalvular leaks were observed in each participant. There were no cases of clinically significant left ventricular outflow tract obstruction, according to the researchers.
Moreover, there were no additional events between discharge and 30-day follow-up.
At a median of 6 months follow-up, all patients were alive and improved to NYHA functional class II, according to the study.
“Good postprocedural valve hemodynamic performance was observed in all patients, with no clinically significant residual leaks or transvalvular gradients, and valvular function was maintained at 6-month follow-up,” Alperi and colleagues wrote. “Longitudinal imaging showed no evidence of structural valve failure and sustained valve performance resulting in significant improvement in functional status and quality of life.”
Researchers also reported that all mitral valve replacements stayed in position, showed no signs of structural frame fractures or erosion of adjacent structures. No evidence of frame compression or deformity was reported.
“All patients included in our study had significant levels of mitral annular calcification, and no patient underwent valvuloplasty before transcatheter mitral valve implantation,” Alperi and colleagues wrote. “The 6-month results support future prospective studies of the Cephea valve system in this complex patient population as well.”
Reference:
Collapse
Alperi A, et al. Abstracts. Presented at: TCT Connect; Oct. 14-18, 2020 (virtual meeting).
Read more about
Click Here to Manage Email Alerts