Paris, France - The MitraClip (Abbott) percutaneous mitral-valve repair device may provide new hope for heart-failure patients who have otherwise run out of options . A small study presented here at the European Society of Cardiology (ESC) Congress 2011 looked specifically at the MitraClip in patients too sick for surgery who have failed to respond to cardiac resynchronization therapy (CRT).
According to Dr Angelo Auricchio (Fondazione Cardiocentro Tincino, Lugano, Switzerland), who presented results of the PERMIT CARE study, the study population was "a very compromised group of patients that has not been previously assessed in any randomized controlled trial."
PERMIT CARE was an observational trial of MitraClip in 51 patients at seven centers; all of the patients were considered ineligible for surgery due to comorbidities putting them at high risk of death. In addition to significant functional mitral regurgitation, all of the patients had heart-failure symptoms that had not improved despite at least six months of cardiac resynchronization therapy (CRT), usually with a CRT defibrillator and optimal medical therapy.
The average logistic EuroSCORE of the patients in the study was almost 30. Dr Piotr Ponikowski (Medical University, Wroclaw, Poland), cochair of the session in which Auricchio presented the PERMIT CARE data, remarked that "anyone dealing with heart-failure patients would call these 'no-option' patients."
Prior to treatment with the MitraClip, all of the patients had mitral regurgitation of at least grade 2, but one year after receiving a MitraClip, only 6% had mitral regurgitation of grade 2 or worse. Prior to getting a MitraClip, 92% of the patients had NYHA class 3 or 4 heart failure, compared with just 22% 12 months later. The average left ventricular ejection fraction and ventricular volume also improved significantly 12 months after the procedure.
"The MitraClip technology was developed for primary valve disease, but the majority of patients are in the heart-failure world, where the mitral valve gets regurgitation or is relatively insufficient because the ventricle is dilated," session cochair Dr Frank Rushitzka (University of Zurich, Switzerland) said. "There's a huge opportunity here."
In the study, the 30-day mortality rate was an "acceptable" 4.2%, Auricchio said. During follow-up, there were nine more deaths, including one sudden cardiac death of a patient with an ICD and three noncardiac deaths. Most of the deaths were within six months of treatment and were more frequent in older patients with a previous valve surgery, a much higher logistic EuroSCORE and mean value of N-terminal B-type natriuretic peptide (NT-pro-BNP), longer QRS duration, and a more dilated heart.
Auricchio said that this pattern suggests that there may be a group of patients whose heart failure has become so severe that they cannot benefit from MitraClip therapy. The ideal patient population for this therapy as well as the best timing for MitraClip therapy after a CRT implant will be studied further, he added.