ACCESS-EU: Encouraging Registry Data on Mitraclip

August 27, 2012

August 27, 2012 (Munich, Germany) — Encouraging new results with the MitraClip (Abbott, Abbott Park, IL) in patients with mitral regurgitation who are unsuitable for surgery have been presented from the largest registry yet with the product.

The new data come from the ACCESS-EU registry, which included 567 patients from four European countries (Denmark, Switzerland, Italy, and Germany).

Presenting the data here today at the European Society of Cardiology 2012 Congress, Dr Wolfgang Schillinger (University Medical Center Göttingen, Germany) said that these new results confirmed the benefits of the MitraClip in patients with mitral regurgitation (MR) at high surgical risk. He explained that this is a different population from that included in theEndovascular Valve Edge-to-Edge Repair Study (EVEREST) randomized trial, which compared the clip with surgical valve repair, in that patients enrolled in the ACCESS registry were generally older and sicker. "These data give us a picture of how the MitraClip is actually being used in the real world," Schillinger added.

On this note, designated discussant of the study Dr Simon Ray (Academic Health Science Centre, Manchester, UK) said: "Clinical practice has evolved beyond the envelope provided by the evidence base of the single randomized trial available."

Schillinger noted that 4500 MitraClip procedures have been conducted in Europe, about half in Germany, where the product is fully reimbursed. He commented to heartwire: "It took time to get going, but numbers are now taking off. There is a large group of patients who may benefit from this procedure, and our data are likely to increase demand in the markets where is it available." He added that although MitraClip is in the European guidelines, the current recommendation is "soft," as very few data have been available. "With the availability of these data, the recommendations could perhaps be a bit stronger," he suggested. The clip is not yet available in the US.

Large unmet need

Schillinger noted that while surgical repair is the best option for degenerative MR in which the valve itself is diseased, many patients are too old and sick to undergo surgery. In addition, surgery does not work so well in functional MR, which occurs more as a result of ventricular dilation rather than anatomical problems with the valve itself. "So there is a large population of MR patients who are not served well by surgery. These patients have few options and are the ones in whom the MitraClip is being predominantly used," he told heartwire .

Patients included in the ACCESS EU registry had an average age of 74 years and many comorbidities, including coronary artery disease (63%) and moderate to severe renal disease (42%). Most had severe heart failure, and 53% had left ventricular ejection fraction less than 40%. Also, 77% had functional MR, and many patients were considered at high risk for mitral-valve surgery, with an average EuroSCORE of 23.

Schillinger reported that in this elderly, symptomatic, high-risk population with multiple comorbidities, there was a high implant success rate (99.6%), low rate of procedural events, and meaningful improvements in NYHA class, MR grade, quality of life, and walking distance. "The MitraClip therefore provides a treatment option for a patient population with an unmet medical need," he commented.

Results showed the median hospital stay for the procedure was six days, with one day in the coronary care unit, and 80% of patients were discharged without the need for extra care. Mortality at 30 days after clip placement was 3.4%, which Schillinger said was "low for this high-risk population." Mortality at one year was 17.3%.

The degree of MR significantly improved, with the "vast majority" of patients having severe grade 3 or 4 MR at baseline, but 79% achieving grade 2 or less by one year.

While 85% of patients had NYHA class heart failure 3 or 4 at baseline, this improved so that 72% reached class 1 or 2 by 12 months. In addition, quality of life improved by 13.5 points on the Minnesota Living with Heart Failure Questionnaire (from 41.6 to 28.1), and the average six-minute-walk test improved by 60 m (from 275 to 334 m).

Patient selection is key

In his discussion of the study, Ray said that the ACCESS-EU registry added important confirmatory data to smaller existing registry studies. "In expert hands, MitraClip is feasible and has an acceptable procedural risk in patients with comorbidities, but the word 'expert' needs to be reiterated," he commented.

Ray stressed that the procedure should be done only to improve symptoms. "There is no evidence that it improves mortality, and there is no point improving MR grade if there is no symptomatic improvement. And as 25% to 35% of patients derive little or no symptomatic benefit, patient selection is a key issue."

Randomized trials planned

Both Schillinger and Ray stressed the need for a pragmatic randomized trial in this population. Schillinger said two such trials are planned: the Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy for High Surgical Risk Patients (COAPT) study in the US in patients with severe heart failure at high risk of surgery and the RESHAPE-HF Trial in Europe in patients with severe heart failure at lower surgical risk. In both trials, the clip will be compared with optimal medical therapy.

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