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TRAMI registry: MitraClip yields favorable 1-year data
In patients with significant mitral regurgitation, treatment with the MitraClip appears to be effective, yielding significant clinical improvements in a high percentage of patients after 12 months, according to recent findings.
In the prospective study, researchers evaluated 749 patients who were treated with the MitraClip (Abbott Vascular) implantation as part of the TRAMI registry between August 2010 and July 2013. Patients included in the TRAMI registry generally were older (median age, 76 years); were mainly men (61.4%); had high estimated surgical risk (median log EuroSCORE, 20%; median STS score, 6%); and had high rates of CAD, renal failure and severely reduced left ventricular ejection fraction.
Follow-up was conducted at a median of 386 days after MitraClip implantation. The researchers conducted a multivariable analysis to determine predictors of 1-year mortality in the MitraClip patient population.
The researchers found that at 1 year, the mortality rate was 20.3%. Causes of death included sudden unexpected death (15%), other CV causes (36.8%), non-CV causes (12.5%) and unknown/unreported reasons (35.5%). They determined the following 1-year cumulative event rates: transient ischemic attack, 3.8%; stroke, 2.1%; and MI, 0.9%. Within the first year of follow-up, rehospitalization due to cardiac decompression occurred in 14.1% of patients, and 17.8% were rehospitalized for other CV reasons.
Also at 1 year, 63.3% of patients from TRAMI had little or no symptoms of HF and were classified as NYHA functional classes I or II (vs. 11% at baseline). Self-reported health status, as determined through EuroQol visual analogue scale, showed a 10-point improvement. More patients reported being completely independent in terms of self-care vs. baseline (74% vs. 58.6% at baseline; P = .005), and more patients reported having no problems in terms of depression or anxiety (66.7% vs. 48.9% at baseline; P = .0001). The following were identified as predictors of 1-year mortality: NYHA class IV (HR = 1.62; P = .02), anemia (HR = 2.44; P = .02), prior aortic valve intervention (HR = 2.12; P = .002), renal failure with serum creatinine of at least 1.5 mg/dL (HR = 1.77; P = .002); peripheral artery disease (HR = 2.12; P = .0003); LVEF less than 30% (HR = 1.59; P = .01), severe tricuspid regurgitation (HR = 1.84; P = .003) and procedural failure, which included operator-reported failure, conversion to surgery, clip placement failure or persistent postprocedure severe mitral regurgitation (HR = 4.36; P < .0001).
“In the TRAMI cohort, the failure of procedural success exhibited the highest [HR] concerning the prediction of 1-year mortality,” the researchers wrote. “However, randomized studies to verify the efficacy of MitraClip therapy and prospective studies to define anatomical criteria that allow a better prediction of procedural success are still required.” – by Jennifer Byrne
Disclosure: Some researchers report receiving personal fees, travel expenses or grants from Abbott Vascular Germany.