Cath Lab Digest - November 2007 - (Page 55)

55 Medtronic Trials Confirm Ability of Interceptor® Coronary Filter System and Export® Aspiration Catheter to Reduce Major Cardiac Events M edtronic, Inc. announced the findings from two clinical trials, AMEthyst and EXPORT, presented at the 19th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation. The AMEthyst trial was an 800patient, U.S.-based multicenter, randomized trial to evaluate the safety and efficacy of the Interceptor Plus Coronary Filter System as an adjunct to percutaneous interventions on saphenous vein bypass grafts (SVGs). The findings demonstrate that when compared to commercially available control devices (Medtronic's Guardwire® Temporary Occlusion Balloon and Boston Scientific's Filterwire EZ™), Medtronic's new Interceptor Plus Coronary Filter System works equally well in reducing major adverse cardiac events (MACE). The Interceptor Plus Coronary Filter has a braided nitinol filter mounted on a 0.014" hypotube. Interceptor Plus is delivered in a closed state into the artery, moved past the blockage and opened before performing conventional stent angioplasty. The Interceptor Plus Coronary Filter maintains blood flow in saphenous vein grafts while trapping the embolic debris. Data from the AMEthyst trial showed that Interceptor Plus met the primary study endpoint to demonstrate safety, MACE at 30 days, indicating non-inferiority of Interceptor Plus compared to control devices. Interceptor Plus also demonstrated efficacy with device success over 90 percent and a low incidence of clinical failure when compared to commercially available control devices. Medtronic’s successful completion of this study enables the company to pur- sue 510(k) clearance with the FDA to market the device in the U.S. Medtronic also announced new findings from the EXPORT trial, a study assessing the safety and efficacy of the Export Aspiration Catheter, a device designed to remove thrombus and embolic material. The study, a randomized, controlled trial of 250 patients at 24 sites in Europe and India comparing the use of Export prior to stent implantation with conventional stenting in patients with acute myocardial infarction (AMI), demonstrated the effectiveness of the Export Aspiration Catheter in improving blood flow in AMI patients. Cleared for use in the U.S. in 2006, the Export XT Aspiration Catheter design allows for deliverability in even the most demanding cases. The fullwall variable braiding design helps eliminate segment joints and weak points in the catheter to improve kink resistance, and has seamless transition of shaft stiffness from one end of the catheter to the other. The device features a soft tip material with a short, beveled design for minimal vessel trauma and improved debris capture, plus a hydrophilic coating for lubricity. Data from the EXPORT trial found Export met its primary endpoint. In patients presenting with an AMI, primary aspiration using the Export Aspiration Catheter is associated with a higher percentage of patients with ST segment resolution of greater than 50 percent at 60 minutes post procedure and/or a myocardial blush grade III immediately post-procedure than in patients with conventional stenting. In addition, primary aspiration using the Export catheter is associated with a lower rate of no-flow, higher corrected TIMI frame count post procedure, and a lower requirement for bail-out techniques. ■ Benefits of MitraClip for Patients with Mitral Regurgitation Shown by New Data T he vast majority of patients who had a successful result with the percutaneous MitraClip device did not need mitral valve surgery three years after their procedure, and many benefited from significantly improved function of the left ventricle (commonly known as reverse remodeling), according to data presented at the Transcatheter Cardiovascular Therapeutics (TCT) symposium in Washington, D.C. During multiple sessions at TCT 2007, researchers participating in the EVEREST II study presented data from a 107-person, non-randomized patient registry. The presentations evaluated the reduction of mitral regurgitation severity with the MitraClip device and the positive impact of this reduction for patients. The ongoing randomized study arm of EVEREST II is evaluating the safety and efficacy of the MitraClip device compared to surgical mitral valve repair or replacement for the treatment of mitral regurgitation (MR, a condition in which blood leaks backward through the mitral valve with each heartbeat, causing the heart to work harder to circulate oxygen to the body). Highlights of the data presented include: • 82 percent of patients who had a successful result with the MitraClip device remain free from surgery 36 months after the procedure. • 74 percent of patients with one or more Clips implanted experienced a reduction to less than or equal to Grade 2+ MR as assessed by the EVEREST Core Laboratory and graded per the American Society of Echocardiography guidelines. • 12 months after a successful MitraClip procedure, significant reverse remodeling of the left ventricle was demonstrated. Reverse remodeling was assessed based on five echocardiographic measures, including left ventricular end-systolic dimension. • In line with the reverse remodeling, 94 percent of patients who had a successful result with the MitraClip device had improved or stable New York Heart Association (NYHA) Class at 12 months following the procedure. Ted Feldman, MD, presented the 36 month followup data at TCT. Dr. Feldman is the EVEREST II national co-principal investigator and director of the cardiac catheterization lab at Evanston Northwestern Healthcare in Evanston, Illinois. “The reduction in MR severity achieved, along with the stability of the results at 36 months and the preservation of subsequent surgical options, leads us to believe that the MitraClip device is likely to become a viable first-line option for treating MR in many patients.” Dr. Michael Rinaldi, who presented the reverse remodeling data at TCT, concurred. “The reverse remodeling data is important in that it provides compelling, objective evidence that the MitraClip device is having a positive impact on patients,” said Dr. Rinaldi, director of clinical research at Sanger Clinic/Carolinas Medical Center. “Additionally, patients with the MitraClip report that they feel better and are able to engage more fully in activities they enjoy.” The EVEREST study continues at more than 35 centers in North America, with more than 300 patients enrolled and more than 300 MitraClip devices implanted to date. Investigators are currently enrolling patients in both arms of the EVEREST II study — a randomized, controlled arm and a high risk registry arm — with the goal of completing enrollment by the end of 2008. “This study is gathering valuable information that cardiac surgeons and interventional cardiologists have never had before. The data provides new insights about treatment considerations for patients with significant degenerative or functional mitral regurgitation,” said Dr. Feldman. “We encourage physicians to refer such patients to EVEREST investigators.” More information about the EVEREST II trial is available at http://www.mitralregurgitation.org/. ■ http://www.mitralregurgitation.org/

Table of Contents Feed for the Digital Edition of Cath Lab Digest - November 2007

Henry Ford Heart and Vascular Institute Treating Patients with Complex Vascular Disease with a Multi-Disciplinary Approach Improving Patient Compliance with Antiplatelet Medications Clinical Editor’s Corner Cath Lab Nurse/Tech Vascular Access and Closure Using the StarClose® Device The Clinical and Economic Impact of Measuring Fractional Flow Reserve FFR and Choosing an Optimal Revascularization Strategy Finally! The New Registered Cardiac Electrophysiology Specialist (RCES) Credential Use of a Mobile Lab to ‘Test the Waters’ at a Rural Hospital Remembering a Cardiac Cath Lab History ACVP• Membership Page What Do You Think? The Ten-Minute Interview with… Ernie Livingston, RN, BSN SICP* Chapter Updates Who’s in Charge? Working to Eliminate Bottlenecks: Florida Hospital’s Cardiac Cath Lab Achieves Greater Efficiency and Higher Satisfaction Preserving Left Ventricular Function during Percutaneous Coronary Intervention Ask the Clinical Instructor: A Q&A Column for Those New to the Cath Lab Making the Most of Your First Impression: Interviewing Tips and Techniques CEU Education Center Clinical & Industry News Meetings Calendar

Cath Lab Digest - November 2007

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