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Echocardiographic Guidance and Assessment of Percutaneous Repair for Mitral Regurgitation With the Evalve MitraClip: Lessons Learned From EVEREST I

2007; Elsevier BV; Volume: 20; Issue: 10 Linguagem: Inglês

10.1016/j.echo.2007.02.003

1097-6795

Frank E. Silvestry, L. Leonardo Rodriguez, Howard C. Herrmann, Sameer Rohatgi, Stuart J. Weiss, William J. Stewart, Shunichi Homma, Neil K. Goyal, Todd Pulerwitz, Alan Zunamon, Andrew Hamilton, John Merlino, Randolph P. Martin, Kimberly A. Krabill, Peter C. Block, Pat Whitlow, E. Murat Tuzcu, Samir Kapadia, William A. Gray, Mark Reisman, Hal S. Wasserman, Allan Schwartz, Elyse Foster, Ted Feldman, Susan E. Wiegers,

Cardiac Structural Anomalies and Repair

Objective Percutaneous mitral repair is rapidly developing as an alternative to cardiac surgery in select patients. The Evalve percutaneous E2E system uses the MitraClip to replicate the surgical suture-based approach. This procedure requires real-time echocardiographic guidance in a unique and significant collaboration between echocardiographer and interventionalist. transesophageal echocardiography (TEE) is used as the primary imaging modality to guide this procedure and is essential to its success. Methods In EVEREST I, the US multicenter phase I safety and feasibility trial, 47 patients with 3 or 4+ mitral regurgitation (MR) were enrolled. The trial involved a standardized echocardiographic imaging protocol with a standardized anatomic-based vocabulary, predetermined standard TEE views, preprocedural strategy meetings, and display of echocardiographic aids to optimize communication and procedural efficiency during placement of the clip. Results TEE guidance facilitated the creation of a double-orifice mitral valve in all 47 patients enrolled (100%), and 40 patients were discharged with 1 or more clips (85%). At discharge, successful placement of a clip and ≤ 2+ MR was present in 34 patients (74%). The standardized approach contributed to a reduction in the time to perform the procedure over the course of the trial at both initial and new sites. Conclusions TEE is essential to the guidance of percutaneous MitraClip E2E repair. A streamlined approach to echocardiographic guidance, using predetermined standardized views, a common anatomic-based vocabulary, preprocedural strategy meetings, and a display of echocardiographic aids in the catheterization laboratory shortens the procedure time and allows for efficient percutaneous repair. Percutaneous mitral repair is rapidly developing as an alternative to cardiac surgery in select patients. The Evalve percutaneous E2E system uses the MitraClip to replicate the surgical suture-based approach. This procedure requires real-time echocardiographic guidance in a unique and significant collaboration between echocardiographer and interventionalist. transesophageal echocardiography (TEE) is used as the primary imaging modality to guide this procedure and is essential to its success. In EVEREST I, the US multicenter phase I safety and feasibility trial, 47 patients with 3 or 4+ mitral regurgitation (MR) were enrolled. The trial involved a standardized echocardiographic imaging protocol with a standardized anatomic-based vocabulary, predetermined standard TEE views, preprocedural strategy meetings, and display of echocardiographic aids to optimize communication and procedural efficiency during placement of the clip. TEE guidance facilitated the creation of a double-orifice mitral valve in all 47 patients enrolled (100%), and 40 patients were discharged with 1 or more clips (85%). At discharge, successful placement of a clip and ≤ 2+ MR was present in 34 patients (74%). The standardized approach contributed to a reduction in the time to perform the procedure over the course of the trial at both initial and new sites. TEE is essential to the guidance of percutaneous MitraClip E2E repair. A streamlined approach to echocardiographic guidance, using predetermined standardized views, a common anatomic-based vocabulary, preprocedural strategy meetings, and a display of echocardiographic aids in the catheterization laboratory shortens the procedure time and allows for efficient percutaneous repair.