TCT2020: Abbott's MitraClip shows promising results in secondary MR as bridge to heart transplantation

Study data presented Friday at the Cardiovascular Research Foundation's TCT Connect symposium demonstrated that Abbott's MitraClip transcatheter mitral valve repair device was safe when used in advanced heart failure patients with significant mitral regurgitation (MR) who are waiting for heart transplants. Findings also showed that two thirds of patients remained free from adverse events at one year.

"These exploratory results are promising and support the further study of MitraClip as an alternative strategy in selected compromised patients with advanced heart failure before transplant," the authors said.

The study evaluated the international MitraBridge registry, including 119 patients with moderate-to-severe or severe secondary MR and advanced heart failure with a median left ventricular ejection fraction of 26%. Participants were treated with MitraClip as a bridge strategy. Among these, 31 were on a list awaiting heart transplantation, 54 were suitable for heart transplantation, but awaiting clinical decisions, and 34 were not yet suitable for a transplant because of potentially reversible relative contraindications.

The primary endpoint was the one-year composite adverse-event rate of all-cause death, urgent heart transplant or implantation of a left ventricular assist device, and first rehospitalisation for heart failure. As a secondary goal, the study looked at the rate of first rehospitalisation for heart failure within the first year after the MitraClip procedure.

Nearly 25% taken off transplant list

The results, which were also published in the Journal of Heart and Lung Transplantation, showed that procedural success was achieved in 87.5% of cases, and 30-day survival was 100%. At one year, estimated freedom from the composite primary endpoint was 64%. By the last available follow-up, which was at a median of 532 days, 15% of patients underwent elective transplant, 15.5% remained or could be included in the heart transplantation waiting list, and 23.5% were no longer indicated for a transplant because of clinical improvement.

MitraClip was approved in the US in 2013 for symptomatic degenerative MR, with Abbott having since introduced later-generation versions of the device. The FDA expanded approval of MitraClip last year to also include use in secondary MR. MitraClip G4, the latest generation of the device, has since been approved for use in the US and more recently in Europe.

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