MitraClip transcatheter mitral valve repair was safe as a bridge to heart transplant and even helped some patients become eligible for transplant, a pilot study showed.
In a largely European registry of 119 chronic advanced or end-stage heart failure patients with 3+ or 4+ mitral regurgitation (MR) who were potential candidates for heart transplantation and got the MitraClip as a bridge strategy:
- 23.5% recovered sufficiently to go off the heart transplant list
- 15.5% became eligible for transplant
Freedom from the primary composite endpoint of all-cause mortality, urgent heart transplant, or left ventricular assist device implantation occurred in 64%, Cosmo Godino, MD, of San Raffaele Hospital in Milan, Italy, reported at the virtual TCT Connect conference.
There were no deaths within 30 days of implantation and 86% procedural success.
The population studied may account for somewhere between 1% and 10% of the total heart failure population and are difficult to manage, with a 1-year mortality risk of 15% on the transplant wait list in Europe, Godino noted.
The study used retrospective clinical records from 119 patients from 17 centers in Europe and Canada:
- 31 were on the transplant list with low likelihood of receiving a donor organ soon due to factors like blood type or body weight
- 54 were awaiting a clinical decision on transplant, dubbed bridge-to-decision
- 34 were not yet listed for transplant due to potentially reversible contraindications, such as severe pulmonary hypertension or elevated pulmonary-vascular resistance, and got the device as a bridge to candidacy
David J. Cohen, MD, of Kansas City, Missouri, noted that the findings did match up with his group’s COAPT trial in that MitraClip was associated with half as many patients going to transplant or left ventricular assist device (LVAD) in that trial.
“Since COAPT came out, we’ve been getting a lot more consults from the transplant service for patients just like this as a bridge to get them safer, keep them out of the hospital, keep them off of inotropes until they’re ready for a destination,” noted Chad Rammohan, MD, of El Camino Hospital in Mountain View, California.
“What’s interesting is that these patients would probably fit into the MITRA-FR data by the size of their LVs [left ventricles], which is interesting because that trial was negative,” he said as part of a discussion panel at a TCT press briefing.
Indeed, about 80% of the population wouldn’t have fit into the COAPT trial criteria, and some were even beyond the MITRA FR criteria, Godino noted. LV end diastolic volume index averaged 122.5 mL/m2.
“So it’s strange that we found some positive results,” he said. The explanation may be the young age of patients, averaging 58 — 20 years younger than that in the MITRA-FR trial, he noted.
“There’s a lot we don’t understand about which LVs are going to benefit — the LV mechanics — and there’s a lot of variability,” agreed panelist Susheel Kodali, MD, of NewYork-Presbyterian/Columbia University Medical Center in New York City. “This is a very sick population, and