Transcatheter device may benefit patients with HF waiting for transplantation

A transcatheter device was a safe and effective bridge strategy to heart transplantation in patients with end-stage HF, with 23.5% removed from the list due to clinical improvement, researchers found in the MitraBridge registry.

“In this scenario, the MitraClip (Abbott) can be utilized as a possible solution as a bridging strategy to heart transplantation in order to reduce worsening and progression of the underlying heart failure disease in this complex, end-stage population,” Cosmo Godino, MD, interventional cardiologist at San Raffaele Hospital in Milan, said during a press conference.

This was a case-by-case retrospective review of clinical records from a multicenter registry of 119 patients (mean age, 58 years; 77% men; mean left ventricular ejection fraction, 26%) with chronic advanced/end-stage HF and concomitant significant mitral regurgitation. Patients were categorized as active on the heart transplantation list (n = 31; mean age, 53 years; 81% men), waiting for clinical decision (n = 54; mean age, 60 years; 76% men) and those not on the list for heart transplantation due to potential reversible contraindications (n = 34; mean age, 59 years; 74% men). All patients were treated with the MitraClip as a bridge strategy.

The primary composite endpoint was 1-year adverse events, including urgent heart transplantation or LV assist device, all-cause death or first HF rehospitalization. The secondary endpoint was first rehospitalization for HF at 1 year. Researchers evaluated the clinical status of patients at the time of last follow-up to determine the number of patients going to elective heart transplantation, those entering or remaining on the transplant list or patients without an indication for heart transplantation.

The procedure was successful in 87.5% of patients, and 100% of patients survived at 30 days. Freedom from the primary composite endpoint at 1 year was 64%.

At 1 year, 15.5% of patients underwent elective heart transplantation, 15% remained on the transplant list and 23.5% were no longer on the transplant list. In contrast, 4.5% of patients died, 6% required urgent heart transplantation and 18% required LVAD.

“These results of the study can be considered as exploratory and as hypothesis-generating,” Godino said during the press conference.

Findings from this study were published in The Journal of Heart and Lung Transplantation in September.

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 in the hospital, keep them off of inotropes until they’re ready,” Chad Rammohan, MD, director of the cardiac catheterization laboratory at Sutter Health in Mountain View, California, said during the discussion at the press conference. “What’s interesting is that these patients probably would fit into the MITRA-FR data by the size of their LVs, which is interesting because that trial was negative vs. COAPT, which is a smaller LV.”

In response, Godino said age may play a factor in these results.

“These were surprising results also for us with one important point: the age of patients,” Godino said during the discussion at the press conference. “The mean age of patients is around 20 years less than the MITRA-FR patients and around 15 years less than COAPT patients. From a pathophysiological point of view, we can suppose that we need more data — also with cardiac MRI maybe in the future (to characterize the extent of preprocedural replacement fibrosis, which is a negative predictor of myocardial wall recovery after the procedure) — that the correction of mitral regurgitation independently from the proportional or disproportional grade from the grade of the left ventricular dilatation can induce a benefit in younger patients.”

“The most obvious thing is even in the sickest patients, the MitraClip was extremely safe,” Saibal Kar, MD, FACC, interventional cardiologist and director of interventional cardiac research at Cedars-Sinai, and co-primary investigator for the COAPT trial, said in the discussion at the press conference. “Putting it in a more simplistic way as a clinician, if I tell a patient who’s almost going to transplant, who cannot get a transplant, who’s a young patient and you tell them it’s extremely safe, that there’s probably a 50% chance you will delay your need for transplant or not need a transplant, they would say, of course, do it. For me, it’s a no-brainer.”

At the discussion during the presentation, Michael J. Mack, MD, FACC, medical director of cardiovascular surgery at Baylor Scott & White Health, said he has some concerns about these data. “I have difficulty interpreting these results,” Mack said. “You have three very different groups of patients, and I’m not so sure that they’re ‘poolable’ to be able to discern any outcomes. In a randomized trial, COAPT, in those patients, we demonstrated a benefit, but you have patients on the waiting list, you have patients waiting for a decision and you have patients that are not candidates for that. I’m not sure what patient that I can discern from this would benefit from this. In addition, there are some patients that went to urgent VAD or transplant. How do we know that this is safe and that we didn’t actually accelerate the need for a VAD or a transplant with that?”