Details of an early feasibility study of transcatheter mitral edge-to-edge repair using the DragonFly (Hangzhou Valgen Medtech) transseptal mitral valve repair system, were presented during a late-breaking trial session during PCR Valves e-course (22–24 November, virtual).
Presented by Jian’an Wang (Heart Center, Zhejiang University, Hangzhou, China), the presentation included details of 15 patients implanted with the device. Detailing the performance of the valve, Wang said that early experience had demonstrated the suitability of the DragonFly for patients with mitral regurgitation of a variety of lesion types, and that the study had verified the efficacy and safety of the device.
Among the 15 patients presented, Wang said, technical success was achieved in 100% of patients, all of whom had an MR ≤2+ or less prior to discharge, with no occurrence of major adverse events. A pivotal study of the device will begin in 2021, he added.
The implanted DragonFly device follows other successful transcatheter edge to edge repair devices, Wang said in his presentation, but added that it also features some notable design innovations. “There are some technological design differences, including a central compressible nitinol filler, as well as interaction with an adjustable closing angle of the grasping arms, along with the unique control of the delivery system,” he said.
“The closing angle of the arms of the device can be adjusted individually to achieve more effective MR reduction as well as avoiding mitral stenosis.”
Wang then presented details of the first patients to receive the DragonFly, which he said demonstrated its ability to reduce in mitral regurgitation. The early feasibility study enrolled patients with severe (3+ or 4+) mitral regurgitation, who were deemed to be high or prohibitive risk for surgery by the heart team.
Study endpoints were a safety endpoint of freedom from major adverse events at 30 days, and an efficacy endpoint of acute procedural success, defined as successful device implantation, and residual MR of 2+ or less at discharge.
In total, 15 subjects were enrolled in the early feasibility study, with an average age of 77.2 (46.6% female). An average 1.4 devices were implanted per patient, with an average procedure time of 79 minutes.
In terms of MR reduction, Wang showed data from echo core laboratory analysis adjudication, showing that at baseline 20% had 3+ and 80% 4+. All patients had MR reduced to 2+ or less at the endpoint, which was sustained to one month, Wang said.
In summary, Wang said: “The DragonFly valve repair system is a transseptal mitral valve repair system with unique features. This early feasibility study can demonstrate safety and efficacy across a range of mitral regurgitation lesion types. Our patients had technical procedure success, with 80% having sustained mitral regurgitation reduction to 1+ or less.
“These encouraging results are leading us into the pivotal study in China, beginning early next year.”