NEW YORK (Reuters Health) – Percutaneous edge-to-edge mitral valve repair using the MitraClip device can be safely performed even in very high risk patients, researchers from Germany report in the September 3rd online American Journal of Cardiology.
“More studies will be needed to get information about long term results,” Dr. Raffi Bekeredjian from University of Heidelberg, Heidelberg, Germany told Reuters Health by email. “However, if long term results are good (and this is what we would expect from present data), it can certainly become a technique of first choice for very high-risk patients. In our opinion, it already has this status.”
Dr. Bekeredjian and colleagues assessed short-term safety and clinical efficacy after MitraClip implantation in 33 very high risk patients with a mean Society of Thoracic Surgeons score of 24%, including 4 critically ill intensive care patients. Three additional patients had unsuccessful attempts of MitraClip implantation.
Mean mitral regurgitation index decreased significantly (from 2.9 to 1.7) and mean NYHA functional class improved significantly (from 3.38 to 2.2) after 30 days. Only 1 patient still had unimproved severe mitral regurgitation at day 30. There were no significant changes at 1 month in mean ejection fraction, mean left ventricular end-diastolic volume, and mean left atrial volume.
On the other hand, there was a significant improvement in the mean 6-minute walk distance (from 194 to 300 meters), and there were insignificant trends in improvement in N-terminal pro-brain natriuretic peptide and high-sensitivity troponin T.
None of the 33 successfully implanted patients died in the first 30 days. Complications included left atrial thrombus in 2 patients and significant access site bleeding, ventilator requirement between 12 and 24 hours, and postoperative delirium in 1 patient each.
“MitraClip is not only a feasible technique but does have the potential to include a patient population that was considered as suboptimal for surgery, that is high risk patients and heart failure patients,” Dr. Bekeredjian said.
“It is very remarkable how the patients’ symptoms improve immediately after the procedure, especially when we treat patients with severely reduced left ventricular function,” Dr. Bekeredjian said. “Patients normally wake up from anesthesia and report 30 min later that their shortness of breath has already diminished.”
“We are just finalizing our one year follow up of patients with severely reduced left ventricular function who have received a MitraClip and will certainly continue our follow up of all our MitraClip patients,” Dr. Bekeredjian said. “In addition we participate in registries that will hopefully give some additional long-term data in the future.”
About 2% of individuals have mitral regurgitation of moderate or greater severity, but it is unclear how many of these need surgery. “This cannot be put into numbers easily,” Dr. Bekeredjian said. “However, we can clearly say that it is an increasing number of patients, since more and more multimorbid and heart failure patients are surviving long enough to develop severe mitral regurgitation. Just as an example: in Heidelberg we may implant about 70-100 patients each year.”
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