Blog | Thursday, October 20, 2011

Study looks into new afib treatment and finds it's not all good news

The news wires for atrial fibrillation (AF) were abuzz this last week. The vigor and speed with which health news travels is striking.

Since 2.6 million Americans live with AF, my guess is that many are looking at the release of the Medtronic-sponsored TTOP-AF trial with anticipation. Here is a link to the press release. The trial purported to show benefits of Medtronic's novel phased RF ablation system in treating persistent AF.

The study was small and released at a relatively small symposium in Venice, Italy. The TTOP-AF trial randomized 210 patients with persistent AF (including flutter) to either ablation with Medtronic's ablation system or conventional therapy with drugs and cardioversions.

They found, not surprisingly, that AF ablation reduced AF burden. AF ablation significantly reduced AF burden in 55.8% percent of patients versus only 26% of those treated with conventional medical treatment. [Editorial comment: That kind of data is pretty typical.]

The problem with the study comes in the safety arm: 21 of 138 patients in the ablation arm "experienced one or more protocol-defined adverse events." This included four patients with manifest stroke, seven with PV stenosis and one death. Post-ablation MRI scans were not reported so we don't know how many patients in each arm had non-symptomatic MRI brain lesions. (See below.)

The still-investigational Medtronic ablation system used in the trial is much different than what is used in the real world. Their PVAC catheter is a novel circular catheter that can deliver simultaneous encircling lesion around the pulmonary veins. The notion is sweet because at the moment we have to deliver single lesions in a labor-intensive point-by-point manner. Placing a catheter just outside the orifice of the vein and making one burn would be great.

The problem with the technology rests in its physics. Energy delivery via the long electrodes on the PVAC catheter (which are not irrigated with saline, like our present catheter), increases the risk of clots forming in the left atrium. It has to do with varying temperatures at varying contact points along the left atrial wall-electrode(s) interface.

In considering the value of this novel technology, it's important to call your attention to this recent paper in the Journal of the American College of Cardiology Here, the highly-respected AF researchers from Bordeaux showed an alarmingly high rate of embolic lesions (clot-related mini-strokes) in patients ablated with the very same PVAC catheter. In this trial, 37.5 % of patients ablated with the PVAC catheter had discrete lesions on MRI brain scans after the procedure.

I've said it before, and it bears repeating:

One of the major tenets of treating AF is to avoid making the treatment worse than the disease.

I'm afraid this technology, in its current form, will not prove safe enough. The risk of stroke is just too high. I'm sure Medtronic is working on making a safer catheter. Hopefully they will succeed.

This post by John Mandrola, MD, appeared at Get Better Health, a network of popular health bloggers brought together by Val Jones, MD. Better Health's mission is to support and promote health care professional bloggers, provide insightful and trustworthy health commentary, and help to inform health policy makers about the provider point of view on health care reform, science, research and patient care.