MitraClip ‘Bridge’ Strategy Continues to Help Sickest HF Patients
With MitraClip, 20% of advanced HF patients awaiting transplant improved enough to no longer require a new heart.
PARIS, France—Two years after undergoing edge-to-edge repair with MitraClip as a bridge to heart transplantation, roughly half of these very sick heart failure (HF) patients received a new heart, became eligible to get one, or no longer required it because their symptoms improved, according to longer-term follow-up from the MitraBridge study.
The new data, which was presented during a late-breaking clinical trial session at EuroPCR 2022, is an update to the 2020 study showing that MitraClip could be an effective bridging strategy for advanced HF patients with secondary mitral regurgitation (MR). At that time, investigators reported that use of MitraClip allowed more than 30% of patients to be safely bridged until a heart became available or their clinical status improved enough to become eligible for transplantation.
Andrea Raffaele Munafò, MD, PhD (University of Pavia, Italy), who presented the updated MitraBridge results, explained the rationale for the bridge treatment.
“In advanced stages of heart failure with reduced ejection fraction, where volume overload and reduced stroke volume play a key role, a significant regurgitant volume might further increase left ventricular end-diastolic pressure and impair stroke volume, [which would] affect the patient’s prognosis,” said Munafò. “The MitraClip treatment might interrupt this maladaptive process and guarantee patients clinical and hemodynamic stabilization and allow safe access to a heart transplantation.”
The bridge strategy included 153 patients who were awaiting transplant but who had a low likelihood of receiving a new heart quickly (bridge to transplant), those not yet listed for transplant because of potentially reversible contraindications (bridge to candidacy), and those with worsening clinical status awaiting a final clinical decision on transplant (bridge to decision).
The 2-year rate of freedom from death, need for urgent heart transplantation or LVAD transplantation, and first hospitalization was 47%. Overall, 55% avoided a first hospitalization during this follow-up period. The annualized rate of HF hospitalization was 45.5% for those who received the device.
Regarding clinical status at 2 years, 19.5% of patients underwent elective transplantation and 12.5% were successfully bridged to eligibility where they were placed on the waiting list. Another 21% of patients no longer required a heart transplantation because of a significant clinical improvement.
Ulrich Schäfer, MD (Marienkrankenhaus Hamburg, Germany), one of the panelists during the session, said there is interest in understanding more about the “responders” who no longer required a transplant because of a clinical improvement. Munafò said further study is needed but noted that these patients tended to have better baseline left ventricular ejection fractions compared with the others.
In terms of baseline echocardiographic characteristics, Munafò said the MitraBridge patients are more closely aligned with patients in MITRA-FR as opposed to the COAPT trial, at least in terms of echocardiographic characteristics at baseline. However, the median age of patients in MITRA-FR was 73 years versus 59 years in MitraBridge, and those included in the registry also had more severely impaired left ventricular function, he said.
e severely impaired left ventricular function, he said.
Munafò AR, Scotti A, Estévez-Loureiro R, et al. 2-year outcomes of MitraClip as a bridge to heart transplantation: the MitraBridge registry. Presented at: EuroPCR 2022. May 19, 2022. Paris, France.
- Munafò reports no relevant conflicts of interest.