German TRAMI Registry Continues to Support MitraClip Use In Elderly Patients

April 12, 2013—Results from the German TRAMI (Transcatheter Mitral Valve) registry are available online ahead of print in EuroIntervention. Wolfgang Schillinger, MD, et al conducted and published the TRAMI study, which evaluated acute outcomes after treatment with the MitraClip (Abbott Vascular, Santa Clara, CA) in elderly patients.

Prof. Patrick W. Serruys, MD, who serves as Editor-in-Chief of EuroIntervention, announced the publication of the article. Prof. Serruys is Professor of Interventional Cardiology at the Thoraxcentre of Erasmus University Hospital in Rotterdam, The Netherlands.

In the announcement, Prof. Serruys stated that the 1,064-patient German TRAMI registry is the largest published real-world cohort of patients treated with the MitraClip and represents approximately 20% of the overall experience with the MitraClip in Europe. The article focused on the influence of age, which Prof. Serruys stated is a very strong, independent risk factor in cardiac surgery and is currently underexposed in actual guidelines on valve therapy.

The German TRAMI registry investigators concluded that elderly and younger patients have similar benefits from MitraClip therapy and that age was the most frequent cause for denying surgery in elderly patients.

As summarized in EuroIntervention, baseline demographics and acute outcomes in 1,064 patients from the German TRAMI registry were stratified by age (525 patients ≥ 76 years and 539 patients < 76 years). In elderly patients, the logistic EuroSCORE was higher (25% [range, 15-40%] vs 18% [range, 10-31%]; P < .0001) and the proportion of women was greater (47.2% vs 29.3%; P < .0001).

Elderly patients were more likely to have preserved left ventricular ejection fraction > 50% (40.1% vs 21.8%; P < .0001) and degenerative mitral regurgitation (MR, 35.3% vs 25.6%; P < .01).

Age was the most frequent reason for nonsurgical treatment in the elderly (69.4% vs 36.1%; P < .0001). The intrahospital rate of major adverse cardiac and cardiovascular events (death, myocardial infarction, stroke) was low in both groups (3.5% vs 3.4%; P = .93) and the proportion of nonsevere MR at discharge was similar (95.8% vs 96.4%; P = .73).

A logistic regression model did not reveal any significant impact of age on acute efficacy and safety of MitraClip therapy. In both groups, the majority of patients were discharged to home (81.8% vs 86.2%; P = .06).

The initial results of the German TRAMI were published in September 2012 in the European Journal of Heart Failure (2012;14:1050–1055). The same investigators concluded, “Data from the German TRAMI registry suggest that MitraClip therapy is a viable treatment option in daily clinical routine for high surgical risk patients with significant MR.”

The MitraClip device received CE Mark approval in 2008 and is commercially available in Europe and other international markets. It is an investigational device in the United States.

On March 20, 2013, Abbott Vascular announced that the US Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee voted 5–3 that the benefits of treatment with the company’s MitraClip device outweigh its risks in patients with significant symptomatic MR who have been determined by a cardiac surgeon to be too high risk for open mitral valve surgery and in whom existing comorbidities would not preclude the expected benefit from correction of the MR.