Two newly published papers (in JACC) have delved into subsets of patients from the EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) High-Risk registry and REALISM Continued Access Study High-Risk Arm. While it’s tricky to draw conclusions from retrospective analysis of a data set, the numbers suggest MitraClip could be beneficial in treating patients with severe MR. The papers were published in this month’s Journal of the American College of Cardiology.
Open heart mitral valve surgery is the standard treatment for MR, but many patients are too sick to undergo major surgery or at significant risk of death if they do.
Last October Abbott Vascular gained FDA approval for use of its MitraClip device in patients with significant symptomatic degenerative mitral regurgitation (MR) who are at prohibitive risk for mitral valve surgery. Around the same time a favourable paper was presented at the annual Transcatheter Cardiovascular Therapeutics 2013 bash, suggesting that 127 patients treated with the device showed changes in quality-of-life measures well above established thresholds.
Abbott Vascular’s MitraClip is a minimally invasive option, working like a sophisticated clothes peg to hold the central portion of the valve’s two leaflets together and in so doing improving their ability to close and resist back flow, the aforementioned regurgitation. The result is a more efficient heart with the consequence that it relieves symptoms, can improve patient quality of life, shorten recovery time and, with that, short hospital stays to two to three days.
The new study data concludes that MitraClip use results in improved outcome measures in higher risk patients than had previously been demonstrated.
327 of 351 patients completed 12 months of follow-up. Patients were elderly, with 70% having functional MR and 60% having prior cardiac surgery. The mitral valve device reduced MR to in 86% of patients at discharge. Major adverse events at 30 days included death in 4.8%, myocardial infarction in 1.1%, and stroke in 2.6%.
A second bit of data drilling, in the form of a 36-item Short Form Health Survey of physical and mental quality-of-life scores, showed improvement from baseline to 12 months (n ¼ 191; p < 0.0001). Annual hospitalization rate for heart failure fell from 0.79% pre-procedure to 0.41% post-procedure. Kaplan-Meier survival estimate at 12 months was 77.2%.
One of the authors, Donald Glower, cardiac surgeon at Duke University Medical Center (Durham, North Carolina) stated that; “The findings were not new, but they surprised some people in that they did hold for the sicker patients. Many people thought that these patients were either too old or too sick and that they’re not going to get any benefit.”
Source: Medical Device Daily