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Transcatheter mitral valve replacement feasible for mitral regurgitation at 2 years
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The reduction of mitral regurgitation after transcatheter mitral valve replacement was maintained over time with no recurrent mitral regurgitation at 2 years, researchers reported.
The findings are the first long-term follow-up report of transcatheter mitral valve replacement for treatment of severe mitral regurgitation in patients at high surgical risk.
“Mitral regurgitation (MR) is one of the most prevalent forms of heart valve disease in Western countries,” Ander Regueiro, MD, MSc, from the department of cardiology at the Quebec Heart and Lung Institute, Laval University in Quebec City, and colleagues wrote. “Mitral valve repair or replacement remains the gold standard for the treatment of MR, but a significant proportion of patients with severe symptomatic MR are not referred for surgery, mainly due to the presence of concomitant cardiac and noncardiac comorbidities leading to an excessive surgical risk.”
To determine outcomes in 13 patients with severe MR at 30 days, 1 and 2 years, Regueiro and colleagues conducted a multicenter registry made up of patients who underwent transcatheter mitral valve replacement with the novel Fortis valve (Edwards Lifesciences) under a compassionate clinical use program. The valve is not yet approved for marketing anywhere in the world.
A multidisciplinary heart team of interventional cardiologists, cardiac surgeons and echocardiographers evaluated all cases, which took place from February 2014 to March 2015 at five centers in Europe and Canada.
Feasibility findings
The researchers found that 76.9% had MR with ischemic origin and mean left ventricular ejection fraction was 34 ± 9%.
Ten patients (76.9%) had technical success and five patients (38.5%) died within 30 days after procedure, according to the study results.
A 30-day follow-up showed mean transmitral gradient was 3 ± 1 mm Hg, with no cases of moderate-severe residual MR or LV outflow tract obstruction.
Researchers reported the death of two patients during the follow-up period due to terminal HF, which led to a 54% all-cause mortality rate.
Except for one patient, all were NYHA class II, and there were no reported cases of valve malfunction.
There were no valve prosthesis fractures or displacement, according to CT exams performed in three patients at 2 years.
According to Regueiro and colleagues, larger and longer-term follow-up studies with currently available devices are warranted.
More study needed
In a related editorial, Cardiology Today Next Gen Innovator Chandan M. Devireddy, MD, and Felipe Albuquerque, MD, both from the division of cardiology, department of medicine at Emory University School of Medicine, agreed with the researchers on the importance of further study.
“Larger and longer-term follow-up studies assessing the safety and efficacy of novel devices are warranted and, ultimately, we should rely on randomized trial evidence to guide our clinical decision-making process,” they wrote. “Setting the stage for future success will depend on the lessons learned from early-stage technology today.” – by Dave Quaile
Disclosures: Regueiro reports receiving grant support from the Fundacion Alfonso Martin Escudero in Madrid. Please see the study for all other authors’ relevant financial disclosures. Devireddy reports serving on the scientific advisory board for Medtronic. Albuquerque reports no relevant financial disclosures.
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