Invasive Cardiology News

MADIT II Type Patients Successfully Risk Stratified By MTWA Microvolt T-Wave Alternans Negative Patients are at extremely low risk of sudden cardiac death. New clinical data demonstrate that MTWA can risk stratify MADIT II type patients to determine which ones will benefit from ICD therapy Cambridge Heart, Inc. announced clinical results at the Cardiostim meeting in Nice, France that demonstrate that Microvolt T-Wave Alternans (MTWA) testing can play a critical role in risk stratifying MADIT II type patients. Dr. Stephan Hohnloser, Director of Electrophysiology at J.W. Goethe University, Frankfurt, Germany presented compelling clinical data demonstrating that MADIT II type patients who tested negative for MTWA are at very low risk of dying suddenly from a cardiac event. The MADIT II trial demonstrated that patients with prior myocardial infarction and left ventricular ejection fraction of 0.30 or less have a mortality benefit from prophylactic placement of an implantable cardioverter defibrillator (ICD). Dr. Hohnloser presented data on 120 MADIT II type patients drawn from two previously published prospective clinical trials involving 957 patients. The primary endpoint of the analysis was sudden cardiac death and resuscitated cardiac arrest. The secondary endpoint also included sustained ventricular tachycardia. Twenty-eight percent of the patients tested MTWA negative, 59% tested positive, and 13% had an indeterminate result. Kaplan Meier analysis at 24 months of follow-up for the primary endpoint revealed an event rate of zero for patients who tested MTWA negative and an event rate of 16.4% for the remaining patients. Similar analysis for the secondary endpoint revealed an event rate of 6% for patients who tested MTWA negative and an event rate of 33% for the remaining patients. MTWA testing successfully identified a subgroup of MADIT II type patients who are at low risk of dying suddenly and therefore should not require ICD therapy. Conversely, MADIT II type patients who do not test MTWA negative would be expected to have a greater mortality benefit from ICD therapy than that reported in the original MADIT II study. Researchers Find Cardiovascular Information System Impacts Productivity and Improves Patient Care Cardiologists, nurses and administrators can now access patient case records in minutes instead of weeks with digitized cardiology information systems, realizing tremendous productivity gains and more targeted patient care, according to a study conducted by Rush-Presbyterian“St. Luke’s Medical Center in Chicago. The study looked at the length of time for reporting processes in the cath lab, from the completion of a procedure to final report generation, both before and after implementation of an advanced cardiology information system. Clinicians and administrators found a significant decrease in report distribution time after implementation of the first generation of Centricity Cardiology Information System from GE Medical Systems Information Technologies. The first study of its kind quantified the dramatic productivity impact the information system provides in the cath lab by enabling cardiologists and nurses to access cardiology care records within 35 minutes compared to nearly three weeks prior to the system’s implementation. Our findings show a dramatic reduction in reporting time, said Gary Schaer, MD, Medical Director of Cardiac Catheterization Laboratory at Rush-Presbyterian-St. Luke’s Medical Center. Reports that once took weeks to generate now can be ready in minutes. The final report is now available immediately after the procedure and can be accessed from any computer workstation in the hospital. To digitally manage the laborious and often manual process of generating and completing cath lab reports, Dr. Schaer implemented Centricity Cardiology. Over a two-month period in 2001, he launched the study to measure the impact of the report workflow process on cath lab productivity, billing and patient care. The cath lab reporting process typically begins with a hand-written report, which is forwarded to a dictation service and revised before finally arriving in Medical Records and at the billing department. Within this often weeks-long cycle, complete information contained in the report is inaccessible to the staff and the patient. Since the final report was produced more expeditiously, as shown in this study, the administration was able to process charges almost immediately after the case was completed. Previously, they would have to wait weeks for the final report before billing. The digitized report is configured in a standardized format to help reduce the time administrators spend searching for information, such as which services were provided. Joint Commission Resources Publishes JCAHO Standards Manual Joint Commission Resources (JCR), a subsidiary of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), announced the publication of From Practice to Paper: Survey Documentation for Laboratories. This book helps laboratory professionals comply with JCAHO standards by demonstrating how to benchmark documentation practices and improve them. From Practice to Paper: Survey Documentation for Laboratories provides example documentation for each functional chapter of the 2002“2003 Comprehensive Accreditation Manual for Pathology and Clinical Laboratory Services, including abridged versions of documents used by laboratory professionals to demonstrate compliance with the standards. Readers also learn what role documents play in the survey process. From Practice to Paper: Survey Documentation for Laboratories is available for $95 using order code SDFL-01. To order, call the Customer Service Center toll-free at 877-223-6866, 8 a.m. to 8 p.m. CT, weekdays, or visit Infomart. PharmaSonics Initiates Clinical Investigation of Intravascular Sonotherapy® for Diabetic Patients Implanted with Drug-Eluting Stents PharmaSonics, Inc. has initiated a new European trial of its anti-restenotic Intravascular Sonotherapy® therapeutic ultrasound system. The DiSPARKLE trial will examine the safety and efficacy of sonotherapy treatment in diabetic patients to enhance the efficiency of drug-eluting stents. The study will also investigate the application of sonotherapy treatment to the total coronary target vessel for the reduction of atherosclerotic disease progression, and for stabilizing vulnerable plaques that might develop within the non-stented segments of the target coronary artery. The trial represents a significant broadening of the investigation of Sonotherapy treatment beyond the reduction of coronary restenosis into new and emerging applications as an adjunct to drug-eluting stents and for the stabilization of vulnerable plaques. The remaining high rate of restenosis, recently observed in diabetic patients receiving drug eluting stents, requires the development of new approaches for this difficult patient population, stated principal investigator Antonio Colombo, MD, of Centro Cuore Columbus, Milan, Italy. As recent research suggests, sonotherapy may play a role in increasing the effectiveness of drug-eluting stents and in inhibiting atherosclerotic disease progression overall. Dr. Colombo commented after having successfully performed the first DiSPARKLE live case during the ongoing Transcatheter Cardiovascular Therapeutics (TCT) 2002 meeting at the Washington Convention Center, Washington, D.C. DiSPARKLE (Diabetics - Sonotherapy Prevention of Arterial Restenosis and Krappy Lesions), a randomized, double-blind study of 180 diabetic patients, will compare the use of sonotherapy treatment versus sham control in de novo coronary lesions. In the treatment group, Sonotherapy will be applied after implantation of drug-eluting stent(s) to the stented segment, as well as the proximal and distal segments. The study will be limited to coronary arteries with diameters of 3.5mm or less. It will include multi-vessel stenting and sonotherapy treatment lengths ranging from a minimum of 40mm to a maximum of 80mm. Preliminary LACI Trial Results The Spectranetics Corporation announced the presentation of preliminary results from its LACI (Laser Angioplasty to treat Critical Limb Ischemia) clinical trial at the Transcatheter Cardiovascular Therapeutics (TCT) convention held in Washington, D.C. Success of any therapy to treat critical limb ischemia is measured by relief of rest pain, healing of ulcers and avoidance of major amputation. We are impressed with the ability of the excimer laser to treat this challenging patient group, which includes diabetics and patients with hypertension and coronary artery disease, said Tony Das, MD of Presbyterian Hospital in Dallas Texas. Acute results, as measured by the establishment of straight line blood flow to the foot, was 89%. Preliminary three month survival with limb salvage is 89%, with slightly more than half of the data available at this time. The data for limb salvage at six months, which is the primary endpoint of LACI, should be available in December. The LACI trial, which includes the use of coronary catheters as well as larger diameter catheters ranging from 2.0 to 2.5 millimeters, enrolled 147 patients and enrollment was completed in April 2002. Critical limb ischemia is a debilitating disease that contributes to more than 80,000 amputations per year in the United States. The company expects to submit the data from the LACI trial and a request for pre-market approval to the Food and Drug Administration in January 2003. The company's CVX-300® excimer laser is the only system approved by the Food and Drug Administration (FDA) for multiple cardiovascular procedures, including coronary atherectomy and the removal of problematic pacemaker and defibrillator leads. The company is currently conducting two investigational trials designed to obtain FDA approval to market products in the United States for additional applications. The LACI (Laser Angioplasty for Critical Ischemia) trial tests laser atherectomy to improve circulation to the lower leg. The PELA (Peripheral Excimer Laser Angioplasty) trial deals with blockages in arteries in the upper leg. Nearly all of the company’s FDA-approved and investigational applications have received CE mark registration for marketing within Europe. Spectranetics received regulatory approval from the Ministry of Health and Welfare to market its laser and various sizes of its Extreme® and Vitesse® C coronary catheters in Japan in October of 2001, and is currently pursuing reimbursement approval there. Intraluminal Introduces Safe-Steer Total Occlusion System IntraLuminal Therapeutics, Inc. (Carlsbad, CA) has introduced its first generation system, called Safe-Steer. Safe-Steer will be the first total occlusion product including guidance to be introduced in the U.S. Most patients will be able to leave the hospital in one to two days, instead of the five to seven days normally required with surgical treatment. Of the 7.6 million patients worldwide who will undergo coronary and peripheral diagnostic procedures this year, 2 million will have one or more total occlusions. Kensey Nash Reports Clinical Updates on TriActiv System Kensey Nash Corporation’s TriActiv Balloon Protected Flush Extraction System was used successfully in a live case at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in Washington, DC. Drs. Gary Roubin and Michael Collins from Lenox Hill Hospital in New York City performed the procedure on a 63 year old male with degenerative saphenous vein graft disease in a 12 year old graft. The TriActiv System is a distal protection system used as part of the procedure to minimize major complications during the saphenous vein graft intervention. In addition to the live case, Joseph Carrozza, MD, principal investigator of the ongoing U.S. randomized PRIDE trial, presented an update of clinical data. Dr. Carrozza presented data which showed a 6.8% (4/59) MACE (Major adverse cardiac event) complication rate for patients treated within the protocols of the pilot phase of the trial. For the overall patient subset treated with the TriActiv System, the rate of in-hospital MACE was 15.3% (11/72). According to recent documented studies, these complication rates often run as high as 20% in non-protected vein graft procedures. The early data on the TriActiv System are encouraging, commented Dr. Carrozza from Beth Israel Deaconess Medical Center. As we analyzed the data, excluding both protocol violations and device failures, the MACE rate falls even further to 5.2%. Furthermore, we are confident that Kensey Nash will continue to improve the device and that the planned enhancements will contribute to further success in the trial. These are promising initial data for this challenging patient subset, he concluded. The TriActiv System is approved for sale in the European Union and was commercialized there in the June quarter of 2002. In the U.S., a randomized trial, the PRIDE trial (PRotection during saphenous vein graft Intervention to prevent Distal Embolization), is being conducted at up to 50 sites and, upon completion, will involve up to 800 patients. The TriActiv System is designed to prevent heart attacks during the interventional treatment of saphenous vein grafts (SVGs) in patients who previously received coronary bypass surgery, but now have blockages in the grafts. The device incorporates three important features to address the common problem of distal embolization: a protection balloon guidewire which creates a protected space, a flush catheter which washes the graft, and an extraction system which removes the debris found in the grafts. These three features work in combination to prevent the debris found in the graft from going down stream and potentially causing a heart attack. Image-Guided Magnetic Catheter Navigation:Robotics in the Cath Lab Siemens Medical Solutions, Inc. has unveiled the first digital imaging system that can work with magnetic navigation systems for interventional medicine. The combination of Siemens’ AXIOM Artis dFC Magnetic Navigation Imaging System and Stereotaxis’ Magnetic Navigation Systems is expected to be capable of helping cardiologists improve the ease and accuracy of catheter-based procedures. Siemens’ combines digital fluoroscopic imaging system, the AXIOM Artis dFC Magnetic Navigation (Flat Panel Detector System), with partner Stereotaxis’ magnetic navigation technology. The system is designed to remotely direct and digitally control catheter-based devices along complex paths within the body. The magnetic-tipped catheter device is controlled by magnets external to the body. This approach allows for 360-degree rotation of the catheter and is anticipated to provide greater precision and better movement than manual methods. Gary L. Schaer, MD, Director, Cardiac Catheterization Laboratories at Rush-Presbyterian St. Luke’s Medical Center in Chicago, commented on his experience with magnetic navigation, noting, I am confident that magnetic navigation during interventional cardiology procedures will prove extremely helpful, especially in tortuous anatomy and chronic total occlusions. The expectations are to integrate fluoroscopic technology with remote catheter control, allowing the clinicians to better leverage the imaging information to ensure the catheter is positioned properly, without trial and error. The system fits into a standard cath lab room, and is designed to allow clinicians to perform the majority of the procedures remotely from the control room using a joystick. This addresses long-term radiation exposure concerns of clinicians working day-to-day in the cath lab. Magnetic navigation has been undergoing clinical trials at various sites in the U.S., including Washington University’s Barnes Jewish Hospital in St. Louis, MO, Rush Presbyterian Hospital Chicago, and at the University of Oklahoma. I think that in the future what we are going to see is robotic-type devices in interventional cardiology, said Patrick Serruys, MD, PhD, Professor of Cardiology at the Thorax Center, Rotterdam, Netherlands I think that, like the neurosurgeon and the surgeon, the interventional cardiologist will be performing procedures using robotics. Five Top U.S. Heart Centers Cite Operational Benefits of Heartlab’s ENCOMPASS Digital Cath Lab Solutions Five of the nation's top heart hospitals have gone on record to acknowledge how Heartlab’s Encompass Cardiac Network is helping them to meet the image and information management needs of their cardiac catheterization labs. These hospitals are: • St. Luke’s Episcopal Hospital, Houston, TX • Wake Forest University Baptist Medical Center, Winston-Salem, NC • Cedars-Sinai Medical Center, Los Angeles, CA • Rhode Island Hospital, Providence, RI • Pitt County Memorial Hospital, Greenville, NC Clinicians at these facilities have cited as significant advantages the Encompass system’s capacity for handling the networking demands of flat panel technology, its ability to provide fast and easy remote access to cardiac images, and its capabilities for long-term digital image storage and retrieval. These advantages have led to operational efficiencies as well as enhanced patient care and teaching capabilities. Heartlab's Encompass connects to all major cardiac x-ray and ultrasound systems using the industry-standard DICOM communications protocol, creating a central repository of digital images from multiple modalities together with the associated physician findings reports. Using Heartlab’s network-connected diagnostic review stations, clinicians can instantly access several thousand diagnostic cardiac catheterization or echocardiography cases stored on the Encompass Enterprise Server, and access in less than 30 seconds cases stored on the Encompass DVD Image Archive. Secure LAN, WAN and Internet access also is available so clinicians can reference patient data from any PC with a Web browser. Completion of Patient Enrollment for Study In Emerging Field of Heart Attack Prevention A Guidant Corporation-supported optical coherence tomography study of complex lesions recently completed enrollment. The study examined images of lesions in patients with coronary artery disease at Massachusetts General Hospital in Boston, MA. Optical coherence tomography is a new coronary imaging technology that provides resolution ten times greater than intravascular ultrasound. Investigators in the Guidant-supported study used this new technology to gather highly detailed information about the unique characteristics of complex lesions that may lead to a heart attack. With 63 patients enrolled, this is likely the largest study of its kind, and I expect the results will stimulate discussion in the interventional cardiology community about the best ways to find and treat vulnerable plaque, said Ik-Kyung Jang, MD, PhD, interventional cardiologist at Massachusetts General Hospital, associate professor of medicine at Harvard Medical School, and principal investigator for the study. Scion Cardio-Vascular Announces Agreement With Medtronic For Distribution Of The Clo-Sur P.A.D. Scion Cardio-Vascular, Inc. announced that Medtronic, Inc. has obtained exclusive rights to distribute Scion Cardio-Vascular’s revolutionary Clo-Sur P.A.D. In addition, Medtronic has made a minority equity investment in Scion Cardio-Vascular. The Clo-Sur P.A.D., manufactured by Scion Cardio-Vascular, is a non-invasive device used for rapid control of bleeding associated with all vascular access sites. The agreement with Medtronic is limited to application of the device for the rapid control of bleeding associated with catheter removal following a catheterization procedure such as coronary stenting, as well as other minimally invasive procedures. Scion Cardio-Vascular has received FDA clearance to market the Clo-Sur P.A.D. in the United States and expects to be granted (CE) Marking approval in September to market the device in Europe. The Clo-Sur P.A.D. has been available for sale in the U.S. since December 2001 and has been very well received by U.S. hospitals and clinicians. In our experience with over 1,000 Clo-Sur P.A.D.s, the device has proven to be safe, effective and easy to use, and most important, it is non- invasive, said Barry Alter, MD, of Memorial Regional Hospital, Hollywood, FL. Emerging Evidence of Reverse Heart Remodeling Gives Further Hope to Heart Failure Patients Whose Hearts Labor to Provide Adequate Pumping Power Cardiac resynchronization therapy for heart failure patients has gained rapid acceptance in the medical community since it was introduced by Medtronic, Inc. just over a year ago. We are seeing very powerful information about reverse remodeling from patients who received cardiac resynchronization therapy and who have been closely monitored for a number of months after implant, said Dr. Martin St. John-Sutton, Professor of Medicine and Director of Cardiac Imaging at the University of Pennsylvania Medical Center in Philadelphia. In patients with heart failure and an enlarged left ventricle, as the heart gets smaller, its function gets better. This is bolstered by a corresponding improvement in quality of life and general heart function. We're putting the dysfunctional heart back into near-normal form.

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