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Clinical trial shows HIFU surgical ablation can be effective in treating atrial fibrillation

St Jude Medical : 25 January, 2008  (New Product)
An independent clinical trial has shown the Epicor Cardiac Ablation System, which is manufactured and distributed by St Jude Medical, is effective in treating atrial fibrillation (AF) when treated concomitantly to corrective heart surgery.
The trial investigators reported that more than 83 percent of all patients, followed for at least six months after surgery, were free from AF. In addition, 86 percent of the patients followed for at least 18 months remained free from AF.

The investigators reported that there were no device or ablative procedure-related adverse events and specifically noted an absence of oesophageal, coronary or phrenic nerve damage.

The clinical trial is the first in the US to examine the safety and efficacy of high-intensity focused Ultrasound (HIFU) therapy for the treatment of AF. The prospective trial was conducted from February 2005 to February 2007 at Mission Hospitals in Asheville, North Carolina, USA. A cohort of 129 patients (who had an ablation performed concomitant to another, already-scheduled cardiac procedure and who were followed at least six months) was assessed in the study. Freedom-from-AF rates were determined through rigorous post-operative physical examinations, electrocardiogram testing, and 24-hour Holter monitoring at six, 12 and 18 months post-ablation.

The results confirmed the findings of a European multi-centre trial published in the September 2005 Journal of Thoracic and Cardiovascular Surgery. The investigators in the European clinical trial reported an 85 percent freedom-from-AF rate at six months post-procedure - the study's primary efficacy end point - in patients concomitantly treated for AF with the Epicor Cardiac Ablation System.'

Recent published reports point to a strong justification to treat AF at the time of other cardiac surgeries in an attempt to improve the long-term patient outcomes of those procedures,' said Mark A Groh, MD, the lead investigator of the study. 'Our study indicates that ablation using high intensity focused Ultrasound can provide a safe and effective option for AF treatment during other heart surgeries.

'Surgical cardiac ablation has been found to provide relief from AF for a high percentage of patients. However, the traditional (non-HIFU) approach requires that patients be placed on a heart-lung bypass machine with their hearts stopped while a cardiac surgeon cuts maze-like patterns in the atrial tissues and then sews the incisions to encourage the formation of lesions, or tiny scars. Surgeons may also use conventional energy sources, such as radiofrequency, laser or microwave, to create lesions in specific heart tissue. The lesions disrupt the abnormal electrical impulses that cause AF.

In surgical ablation performed with a HIFU energy source, energy is focused from outside a beating heart to create precise and complete lines of cardiac tissue ablation to block chaotic electrical impulses. The patient does not need to be placed on a heart-lung bypass machine nor is the heart stopped. Because HIFU energy is directed from outside the heart inward (instead of from the inside out as is sometimes the case in ablations performed with other energy sources), the risk of unintended peripheral damage is minimised.

St Jude Medical manufactures the HIFU ablation device used in the study, the Epicor Cardiac Ablation System. The device has received clearance from the US Food and Drug Administration (FDA) for the surgical ablation of cardiac tissue, but it has not been indicated by the FDA specifically for the treatment of AF. The Epicor System gained regulatory approval for the treatment of AF in Europe in 2006.
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