Transcatheter Heart Valve Procedures Generate Embolic Brain Lesions in Most Patients

Recently, clinical investigators using both the Edwards and Medtronic transcatheter heart valves reported that in the majority of patients undergoing a transcatheter valve implantatioclick to enlargen, one or more embolic induced lesions are created in the brain, presumably from calcific embolic material breaking loose during the procedure. Emboli could be created while traversing the arch, performing the balloon valvuloplasty (common to all procedures), or during  the actual stent implantation.  In both the Medtronic / Corevalve Emboli Study (22 pts) and the Edwards / Sapien Emboli Study (29 pts femoral / 31 apical), the investigators reported that over 65% of patients undergoing a transcatheter procedure had at least one measurable new brain lesion post procedure identified by MRI (diffusion weighted imaging, 1.5 Tesla). In patients identified with atleast one new lesion, the average number of new lesions ranged from 3.4 to 3.7  per patient for femoral procedures to 7.6 lesions per patient for transapical procedures. Lesion volumes were as big as 5,000 cubic millimeters (if spherical, over 2 cm in diameter). For comparison, I included in the charts shown at the right similar data from a recent study by Bonati, et. al in Lancet/Neurology measuring new brain lesions identified after surgical carotid endarterectomy (MRI, diffusion weighted imaging, 1.5 or 3.0 Tesla).

In the transcatheter studies, there were 3 strokes (3.4%) observed immediately post procedure (one in each group).  Simple neurological work-ups performed 30 days later in both studies showed no long term effects in the remaining patients.  What is the significance of the study results?  Is it business as usual, with patients accepting a reasonable “neural deficit” potential?  Or, is it an early warning sign of potential long term unwanted neurological consequences inherent in the procedure.

In closing, I would like to echo a quote from Dr Stephan Windecker (University Hospital, Bern, Switzerland), a leading expert in transcatheter procedures, after he reviewed the Edwards data.

“You wonder, do they matter? I’m not an expert . . . but my question would be, are these reversible, and what do they mean?”

Dr Stephan Windecker, HeartWire, May 27, 2010

Post Implant MRI Images

2 Comments

  1. tsanko
    Posted October 18, 2010 at 9:05 am | Permalink

    Wonderful ..thanks a lot for posting a good informitive blog

  2. Posted October 21, 2010 at 5:27 pm | Permalink

    It agree, this rather good idea is necessary just by the way

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