Transcatheter mitral valve replacement may benefit patients with mitral regurgitation
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At 30 days, a group of 15 patients who underwent transfemoral transcatheter mitral valve replacement for moderate to severe mitral regurgitation had no deaths, strokes, reinterventions or new pacemakers, a speaker reported.
According to data from the early feasibility study of the transcatheter mitral valve replacement system (Intrepid TMVR System, Medtronic) presented at TCT 2021, about half of these patients experienced major bleeding events associated with access-site complications; however, the researchers observed favorable hemodynamics, near complete elimination of mitral regurgitation and improved NYHA class in all participants.
“The delivery system is a transfemoral 35F sheath and the delivery system has a guide and an inner catheter that is designed to deliver the Intrepid valve to the mitral valve annulus in maneuvers that are similar with other transfemoral mitral interventions,” Firas Zahr, MD, director of interventional cardiology, co-director of complex heart valve program and associate professor in the division of cardiovascular medicine at Oregon Health and Science University, said during a presentation. “The valve itself is a conformable outer stent anchor that does not rely on leaflet capture. It has a circular inner stent that is a 27 mm trileaflet bovine pericardial valve with a symmetrical design that does not need any rotational alignment. The valve is currently available in 42 mm and 48 mm sizes. A 54 mm valve is under development. The transfemoral Intrepid valve is identical to that transapical Intrepid valve.”
For the INTREPID nonrandomized multicenter trial, researchers evaluated the 30-day outcomes in 15 patients with moderate to severe mitral regurgitation who underwent a procedure with the Intrepid system.
At 30 days, there were no occurrences of all-cause mortality, stroke, transient ischemic attack, reoperation or reintervention, new pacemaker implantation or stage 2 or greater acute kidney injury.
A total of seven patients experienced Mitral Valve Academic Research Consortium major bleeding events; six had access-site complications; and one patient was rehospitalized for a minor vascular complication, according to the study.
In addition, 73% of patients had closure of an iatrogenic atrial septal defect.
Thirty-day echocardiographic outcomes were evaluated in 14 out of 15 patients. At baseline, 64% of participants were classified as having severe mitral regurgitation and 36% were classified moderate to severe. At 30 days, 100% of participants had no or trace mitral regurgitation. Paravalvular leak was present in 7% at discharge, but all instances were corrected at 30 days.
The researchers observed improvements in 30-day functional outcomes (P = .01). At baseline, 7% of patients were NYHA class IV; 60% NYHA class III; and 33% class II. At 30 days following TMVR, no patients were any longer classified as NYHA class IV; 15% were class III; 57% were NYHA class II; and 29% were NYHA class I.
“Thirty-day results from the Intrepid TMVR transfemoral early feasibility study demonstrate no mortality, stroke, reinvention or pacemaker implantation at 30 days,” Zahr said during the press conference. “Almost half of the patients had major bleeding events primarily related to vascular complications. There was very favorable hemodynamics and almost complete elimination of mitral regurgitation at 30 days with significant improvement in New York Heart Association class.”
During a discussion at the press conference, Susheel Kodali, MD, director of the Structural Heart & Valve Center at NewYork-Presbyterian/Columbia University Medical Center, raised concerns regarding the large sheath size of the delivery system.
“We've all learned that transapical is just not a viable procedure for a lot of these patients. We've got to get to transfemoral,” Kodali said. “There are two components: There's the Intrepid valve and how that functions, and the focus of this study is really on how to deliver the valve. Thirty-five French is going to be too big, but it is the first step to iterate to a smaller device.”
Reference:
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Zahr F, et al. Late-Breaking Clinical Science Session III. Presented at: TCT Scientific Symposium; Nov. 4-6, 2021; Orlando, Florida (hybrid meeting).
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