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The delegation communicated its findings from the review meeting to the full committee, which reached consensus on the merits of the proposal and on the following advice to the Ohio Department of Development.

The Atrial Fibrillation Innovation Center (AFIC) represents a collaborative arrangement between the Cleveland Clinic Foundation, Case Western Reserve University, the University of Cincinnati and several private companies including AtriCure, Inc., Biocontrol Medical Ltd., Cyberonics, Inc., Hansen Medical, Philips Medical Systems, Sinus Rhythm Technologies, Inc. (SRTI), St. Jude Medical, Symphony Medical, Boston Scientific and CardioNet, Inc. Of the commercial partners, AtriCure, Symphony, SRTI and Philips either have operations in Ohio or will move operations there if the project is funded.

The group has requested approximately $15.5 million in capital funds and $8 million in operating funds over 3 years. Most of the capital funds ($11.5 million) will be used to build and equip a 16,000 square foot dedicated facility to house the AFIC. The group has also requested $7,995,923 in operating funds, the majority of which is requested for personnel costs.

Scientific Overview:

The committee felt that the effort to engage in an all-out assault on atrial fibrillation is an outstanding choice of direction for the Cleveland Clinic. This is an increasingly prevalent disease of the aging, which was once poorly managed with medicine and now more successfully addressed with surgical or interventional approaches. Today, the best treatment for atrial fibrillation involves electrical isolation of the pulmonary veins from the rest of the atrial tissue.

The AFIC project approaches the problem using both surgical and interventional approaches. Tools to improve surgical ablation of atrial fibrillation are already in development by Atricure and gaining market share. However, important tools, such as the real-time application of cardiac electrical mapping, which would effectively localize specifically which tissue to isolate and which could help determine when atrial foci had been segregated, is not a real-time procedure in the OR. AFIC surgical projects will try to adapt real-time electrocardiomapping to the OR environment, to improve tools available to create precise atrial lesions, and to develop techniques to perform the operation using minimally invasive techniques (as opposed to open chest surgery).

From the interventional perspective, many sites are exploring a wide variety of techniques to create atrial tissue lesions from within the left atrial chamber. These approaches involve transeptal interventions, which provide access to each of the four pulmonary veins and the left atrial appendage. However, once within the left atrium, manipulation of catheters to the oblique location of pulmonary veins can be difficult, time-consuming, and physically taxing to the operator. The committee was impressed that the Cleveland Clinic is a leader in this area, having, for example, reduced the amount of time required for catheter-based intervention from the typical eight hours to only three.

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