MitraClip is a safe and effective bridge strategy for patients with significant mitral regurgitation and advanced heart failure (HF) as they wait for a heart transplant, according to new findings presented Friday, Oct. 16, at TCT Connect 2020. Some patients may even improve enough that the heart transplant is no longer necessary.
The research, which was also published in the Journal of Heart and Lung Transplantation, included data from 119 patients treated at one of 17 facilities in Europe and Canada. The median patient age was 58 years old. Hospitalization for HF within the previous six months was reported for 61.5% of patients.
The team’s primary endpoint was the one-year composite adverse events rate of all-cause death, urgent heart or left ventricular assist device implantation and first rehospitalization for HF.
Overall, the MitraClip procedure was a success in 87.5% of cases, and survival after 30 days was 100%. At the time of the last available patient follow-up, the authors found that 15% of patients had undergone an elective transplant and another 15.5% were still on heart transplant waiting list. For 23.5% of patients, however, there was no more need for a heart transplant due to “clinical improvement.”
“These exploratory results are promising and support the further study of MitraClip as an alternative strategy in selected compromised patients with advanced HF before transplant,” wrote lead author Cosmo Godino, MD, San Raffaele Scientific Institute in Milan, Italy, and colleagues. “Patients with advanced HF comprise an estimated 1% to 10% of the overall HF population, and the prevalence is increasing because of the growing number of patients with HF and their better treatment and survival. This is a clinical area where conventional treatments (i.e., guideline-directed drugs, percutaneous devices, conventional surgery) are often insufficient in reducing a patient’s symptoms, and advanced (e.g., cardiac transplantation, mechanical cardiac support) or palliative therapies (e.g., inotropic infusions, ultrafiltration or peritoneal dialysis to control volume, or end-of-life comfort care) are needed.”
Additional research is still needed, the authors added, and these findings “should be considered exploratory and hypothesis-generating to guide further study for percutaneous intervention in high-risk patients with advanced HF.”
One co-author did report receiving grants and personal fees from Abbott, the manufacturer behind MitraClip.
The full study is available here.