Intrepid Pilot: Transcatheter mitral valve replacement may be safe alternative to surgery

The use of a transcatheter mitral valve replacement system appears to be safe and effective in the treatment of patients with mitral regurgitation who were considered ineligible for conventional valve surgery, according to the results of the Intrepid Pilot study, presented at TCT 2017.

“These early outcomes with the Intrepid [transcatheter mitral valve replacement] system (Medtronic) are encouraging as we investigate a minimally invasive alternative to surgical mitral valve replacement,” Paul Sorajja, MD, from the Valve Science Center at the Minneapolis Heart Institute Foundation and presenter of the Intrepid Pilot Study data, said in a press release from Medtronic. “The Intrepid [transcatheter mitral valve replacement] system is easy to implant in the challenging mitral anatomy due to its conformable, dual-stent design and the device corrects the underlying mitral regurgitation in a significant majority of patients.”

The Intrepid Pilot study evaluated valve safety and performance of the transcatheter valve replacement system in 50 patients from 14 hospitals in Australia, Europe and the U.S.

Patients were included in the study if they had symptomatic, severe mitral regurgitation, were deemed by the local heart team as being a high or extreme surgical risk, had native mitral valve geometry and size compatible with the transcatheter mitral valve replacement, mild or no mitral valve calcification and left ventricular ejection fraction of 20% or greater.

According to the procedural results of the study, median procedure time was 100 minutes and the median time of deployment was 14 minutes.

The study showed that there were no incidences of device malfunction, device failure or conversions to open cardiac surgery.

The study results showed a device implant rate of 98% (48/49 patients).

At 30 days, the mortality rate among patients in the study was 14% with no incidence of stroke or repeat revascularization.

At 1 year, the survival rate for patients in the study was 77%.

Rates of mitral regurgitation were mild or nonexistent among all survivors.

“Transcatheter mitral valve replacement with the Intrepid is feasible and results in a correction of [mitral regurgitation] in symptomatic patients at higher surgical risk. Stable valve function was observed and a majority of patients experienced symptom improvement,” Sorajja said during his presentation. “Certainly, further investigation will determine the role of this therapy in a broader patient population for surgery and other transcatheter techniques.” – by Dave Quaile

Reference:

Sorajja J. First Report Investigations 3. Presented at: TCT Scientific Symposium; Oct. 29-Nov. 2, 2017; Denver.

Disclosure: Sorajja reports he receives consultant fees and honoraria from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Integer and Medtronic, as well as grants from Abbott Vascular, Boston Scientific, Edwards Lifesciences and Medtronic.