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Benefits of MitraClip similar in elderly, younger patients
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Results from the largest real-world cohort of patients treated with MitraClip ever published show low rates of intrahospital MACCE and a similar proportion of nonsevere mitral regurgitation at discharge in elderly and younger patients.
The study, which was recently published online ahead of print by EuroIntervention, included 1,064 patients from the German TRAMI registry who were stratified by age (525 elderly patients aged ≥76 years; 539 younger patients aged <76 years) and treated percutaneously with the MitraClip (Abbott Vascular). Most patients in the registry had severe mitral regurgitation.
Overall, elderly patients were more likely to be female (47.2% vs. 29.3%; P<.0001) and have a higher EuroSCORE (25% vs. 18%; P<.0001), preserved left ventricular ejection fraction >50% (40.1% vs. 21.8%; P<.0001) and degenerative mitral regurgitation (35.3% vs. 25.6%; P<.01).
Researchers found that age was the most frequent factor for nonsurgical treatment in elderly patients. The rate of intrahospital MACCE — a composite of death, MI and stroke — was low in both groups (elderly, 3.5% vs. younger, 3.4%; P=.93), and the proportion of nonsevere mitral regurgitation at discharge was similar (elderly, 95.8% vs. younger, 96.4%; P=.73).
Additional analysis in the form of a logistic regression model did not indicate any significant effect of age on acute efficacy and safety of the MitraClip.
After the procedure, most of the patients were discharged home (elderly, 81.8% vs. younger, 86.2%; P=.06).
“MitraClip has the potential to close a relevant treatment gap in elderly patients with severe mitral valve regurgitation. Further investigations are necessary to identify patients from pre-interventional characteristics who are likely to derive a benefit from the procedure,” the researchers wrote, adding that a consensus finding is required to define indications for the MitraClip and surgical techniques in elderly patients.
Disclosure: Schillinger has received lecture fees, study honoraria and travel expenses from and is member of an advisory board of Abbott.
Perspective
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Jason H. Rogers, MD, FACC, FSCAI
This study is another important contribution to our understanding of the “real-world” application of the MitraClip (in Germany), specifically as it relates to high-risk “older” and “younger” patients.
The investigators demonstrate that MitraClip therapy in older high-risk patients is feasible with low in-hospital adverse event rates. MR reduction is achieved in both elderly and younger patients. Given the high number of implants worldwide to date (>7000) and numerous prior reports in high-risk and generally elderly groups, the notion that MitraClip therapy is feasible in older patients is not novel, but the size of this report (503 “older” patients) warrants attention. Because of the observational nature of this study and lack of a comparator or control group, the manuscript cannot definitely answer the question of whether MitraClip therapy in these elderly patients is in fact better than medical therapy or surgery — but since surgery was not offered these patients, MitraClip remains the only reasonable option for many patients.
There are some interesting and perhaps surprising findings: elderly patients more often had preserved LVEF and degenerative MR (MR) than younger patients, although the majority still had functional MR and LV dysfunction. These findings in the elderly group may have important implications for trial design and patient selection in elderly cohorts (ie, many high-risk older patients have degenerative MR and treatment should be offered to these patients). In-hospital outcomes were also very similar with no difference in MACCE (despite a statistically higher incidence of transient ischemic attacks and severe bleeding in the elderly group). A limitation of this study was incomplete follow-up with only 81.8% of elderly patients and 86.2% of younger patients available. The most striking difference was that the mortality post-discharge at about 3 months was markedly higher in the elderly group: 15% in the elderly group vs. 9% in the younger group. Longer-term follow-up of these patients is essential to understand the impact of MitraClip therapy. The mortality of treated older patients in this trial mimics that of other high-risk cohorts reported in the MitraClip literature, such as that of cardiac resynchronization therapy non-responders and inoperable patients.
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