Clinical and Industry News

Beaumont Treats First U.S. Patient in Trial of New Heart Valve Implanted Without Open-heart Surgery Cardiologists at William Beaumont Hospital, Royal Oak, Mich., announced they have treated the first U.S. patient in a new clinical trial of a heart valve implanted without open-heart surgery. On March 10, doctors inserted a new aortic heart valve in a 76-year-old man from Casco, Mich., through a procedure performed in a cardiac catheterization lab. The experimental procedure marks the launch of a research study approv ed by the Food and Drug Administration in January to assess a breakthrough technology that could save the lives of thousands of people with heart valve disease who have no other treatment options. This experimental procedure may offer hope to seriously ill, high-risk patients who are not candidates for traditional open-heart surgery, says William O’Neill, MD, Beaumont’s chief of Cardiovascular Disease and principal investigator of the U.S. multi-center trial, REVIVAL. If proven successful through our research, it could revolutionize the way heart-valve disease is treated for some patients, especially for those who are too sick to have open-heart surgery. The procedure, known as percutaneous heart valve replacement, utilizes the Cribier-Edwards aortic heart valve, a technology being developed by Edwards Lifesciences Corporation of Irvine, Calif., that was invented by Alain Cribier, MD, chief of Cardiology, University Hospital in Rouen, France. Dr. Cribier was present at the March 10 procedure at Beaumont, performed by Dr. O’Neill together with cardiologists Theodore Schreiber, MD, and George Hanzel, MD. During the procedure, the replacement tissue valve is compressed to about the diameter of a pencil in size, then is threaded through a patient’s circulatory system into the heart. The valve is positioned within the patient’s existing aortic valve and expanded by a balloon to about the diameter of a quarter. This secures the replacement valve into place and pushes the diseased valve’s leaflets against the aortic wall. Unlike conventional valve-replacement surgery, the procedure can be performed on a beating heart under local anesthesia in about half the time (two hours versus four to six hours). Recovery time is also reduced from months to weeks and the risk of infection may be reduced. Participation in the Beaumont phase one randomized research study of the experimental procedure is limited to 30 people with a documented history of heart valve disease who are too sick for open-heart valve surgery. About 300,000 people worldwide have heart-valve repair or replacement surgery each year. There are many others who are not referred for treatment or who can’t or won’t have surgery. When opened in the heart, the Cribier-Edwards heart valve is about the diameter of a quarter. Non-surgical aortic heart-valve replacement has proven to be feasible through laboratory testing and through clinical trials in Europe. A European patient was the first in the world to undergo the procedure in 2002 and about 40 cases have been performed outside the U.S. Witt Biomedical and InSiteOne Form Co-marketing Partnership to Benefit Customers Witt Biomedical Corporation, a cardiology image and information management systems (CIIMS) provider, and InSiteOne, a digital medical image archiving provider, have announced a co-marketing partnership to provide customers with more options for complete storage management solutions. According to Witt Biomedical President Mike Wolfe, Calysto for Cardiology encompasses the acquisition, review, archival, plus web-enabled access of all modalities across the cardiology enterprise. With this new alliance, we now offer our customers the additional option of InSiteOne’s Index on-site and off-site storage and disaster recovery services. HIPPA regulations and security concerns have made off-site storage and disaster recovery an attractive alternative to on-site storage alone. InSiteOne President Jim Champagne agreed, adding, Customers can now enjoy Witt’s technology and our comprehensive product line of DICOM storage solutions. Our new InDex® Recovery Plus service provides a disaster recovery service that meets the demands of all medical data, including databases that drive PACS. Our two-off site redundant data centers in Connecticut and Arizona offer healthcare providers peace of mind. They know that their critical data is safe and secure. ESC Releases the first European Guidelines on Percutaneous Coronary Interventions (PCI) The European Society of Cardiology (ESC) has released the first European Guidelines on Percutaneous Coronary Interventions (PCI), pre-published and accessible on the ESC website(1). According to these Guidelines, PCI can now be regarded as the first option for a larger group of patients with acute coronary syndromes (ACS) than before. Recent technical and pharmacological improvements have developed PCI into a procedure that can be safely and effectively applied to patients with various types of coronary lesions and patients with and without myocardial infarction. The ESC Guidelines on PCI represent the consensus of a Task Force of European expert1, chaired by Professor Sigmund Silber of the Gemeinschaftspraxis Hospital, Munich, Germany, Fellow of the ESC. Professor Silber outlines the highlights of the Guidelines and summarises the recommendations, whilst outlining the rationale behind their timing and their relevance to the European healthcare arena. One of the most pertinent points of the ESC guidelines is that thrombolysis for myocardial infarction can be administered within the first 3 hours after onset of chest pain, if no catheter lab is accessible, preferably within 90 minutes. Thrombolysis, however, should not be regarded as the final treatment stage: even if successful, thrombolysis should still be followed by invasive diagnosis and treatment, if applicable. A patient may feel fine after thrombolysis, but there is significant evidence that he/she should still undergo cardiac catheterisation, optimally within 24 hours after successful thrombolysis. Due to the differences in the infrastructure between the USA and Europe, the ESC Guidelines differ from those of the USA (issued by the American College of Cardiology and American Heart Association)2 when addressing issues of time and distance to catheter laboratories. The European Guidelines are based on the likelihood that most patients can reach a catheter laboratory, preferably within 90 minutes after first medical contact, if an appropriate network logistic has been established. Furthermore, the ESC Guidelines do not demand cardiac surgery on-site for PCI, since so many more hospitals are in a position to offer high-quality PCI. But the number one rule, worldwide, is: as soon as the patients feel chest pain, like a heart attack (especially those patients who have previously had a heart attack), they must immediately call or let somebody call for an ambulance. Even the best physician cannot help if the delay is too great. These Guidelines aim to present all the relevant evidence on PCI in order to help physicians weigh the risks and benefits of diagnostic and therapeutic procedures in their daily clinical decision-making. 30 pages of practically-oriented recommendations address when to perform PCI on the basis of currently available, peer-reviewed, published data, derived from randomised and nonrandomised clinical studies. A top-line summary of these recommendations follows: 1. PCI can be considered a valuable initial mode of revascularisation in all coronary artery disease patients with objective large ischaemia, and this is the case for every lesion subset except chronic total occlusions that cannot be crossed. 2. The addition of stents and newer adjunctive medications has improved PCI outcome. The decision to recommend PCI or CABG surgery will be guided by technical improvements in cardiology or surgery, local expertise and patients’ preference. 3. Until proven otherwise, PCI should be used only with reservation in diabetics with multi-vessel disease and in patients with unprotected left main stenosis (although developments in drug-eluting stents may eventually alter this situation). 4. Patients presenting with NSTE-ACS (unstable angina or myocardial infarction without ST-segment elevation) have to be stratified first for their risk of acute thrombotic complications. A clear benefit from early angiography (3 Guidelines are crucial to appropriate clinical practice, comprising specific recommendations on treatment methods, collated by senior European experts and opinion leaders in the field. For maximal relevance, Guidelines must be well presented, practical and relevant to the clinician on both a national and local level. The formulation and continual update of such Guidelines is one of the primary activities of the ESC. The ESC aims to produce Guidelines that both encompass and allow for national variations across Europe and works with its National Cardiac Society members to facilitate national adaptations and translations of each Guideline issued. References 1. Guidelines for Percutaneous Coronary Interventions of the European Society of Cardiology: Sigmund Silber, Chairperson (Germany), Per Albertsson (Sweden), Francisco F Avils (Spain), Paolo G Camici (UK), Antonio Colombo (Italy), Christian Hamm (Germany), Erik Jorgensen (Denmark), Jean Marco (France), Jan-Erik Nordrehaug (Norway), Witold Ruzyllo (Poland), Philip Urban (Switzerland), Gregg W Stone (USA), William Wijns (Belgium). https://www.escardio.org 2. Smith Et Al., ACC/AHA Guidelines For Percutaneous Coronary Intervention (Revision Of The 1993 PTCA Guidelines), Jacc Vol. 37, No. 8, June 2001:2215-38 3. https://www.sigmund-silber.com Distal Embolization System Does Not Provide Benefit for Heart Attack Patients Gregg W. Stone, MD, of Columbia University Medical Center and Cardiovascular Research Foundation, New York, and colleagues performed a clinical trial to evaluate the usefulness of distal microcirculatory protection during mechanical reperfusion therapy in acute myocardial infarction (AMI). The randomized controlled trial was conducted at 38 academic and community-based institutions in 7 countries, enrolling 501 patients aged 18 years or older with ST-segment elevation myocardial infarction (STEMI) presenting within 6 hours of symptom onset and undergoing primary PCI or rescue intervention after failed thrombolysis. The patients were randomized between May 20, 2002, and November 21, 2003 to receive PCI with a balloon occlusion and aspiration distal microcirculatory protection system vs. angioplasty without distal protection. Among 252 patients assigned to the distal protection group, aspiration was performed in 97 percent (242/251), all angioplasty balloon inflations were fully protected in 79 percent (193/245), and visible debris was retrieved from 73 percent (182/250). Complete ST-segment resolution (STR) was achieved in a similar proportion reperfused with vs. without the distal protection device (63.3 percent vs. 61.9 percent, respectively; and left ventricular infarct size was similar in both groups. Major adverse cardiac events at six months occurred with similar frequency in the distal protection group and in the control group. We did not identify clinical usefulness of distal microcirculatory protection in AMI, and its routine use in patients undergoing mechanical reperfusion therapy cannot be recommended. Multiple explanations may be proposed as to why distal microcirculatory protection failed to enhance myocardial reperfusion success, reduce infarct size, or improve clinical outcomes in the present trial. First, the device may not have been efficient enough in aspirating liberated atherothrombotic debris, the authors write. Second, the additional median 21-minute delay to angioplasty in the distal protection group or the several extra minutes of additional balloon occlusion may have increased infarct size and worsened clinical outcomes, offsetting the potential benefit of emboli removal, though most prior studies have suggested that this degree of delay at a median reperfusion time of 3.6 hours would be unlikely to affect myocardial salvage or survival. (Source: JAMA. 2005;293:1063-1072.) Sutura, Inc. Announces Positive Initial Reaction To SuperStitch Product In U.S. And Europe Sutura®, Inc., a California-based medical device company, announced that initial reaction to the new SuperStitch® product in Europe and the U.S. has been positive. The ‘As Simple As 1-2-3 Concept,’ which Sutura believes makes it easier for physicians to deploy the SuperStitch, closes the femoral puncture site using the catheter sheath introducer to access the femoral artery wound. In January, Sutura began accepting sales orders for the next generation SuperStitch in the United States as well as Europe. These orders follow a physician and clinician training program to assure proper and consistent use of the device, assuring reorders and satisfied customers. Heartlab Expands Storage Backup Options for Cardiology Images and Information Heartlab, Inc. announced the availability of its Remote Archive DVD library for data backup of cardiology images and information. Heartlab’s Remote Archive provides hospitals with automated HIPAA-compliant patient data backup on industry-standard, DICOM-compliant DVD-R media. Remote Archive works in conjunction with multiple types of storage systems, including Heartlab’s StoreSafe DVD storage archive and a variety of enterprise storage solutions such as storage area network (SAN), networked attached storage (NAS) and content addressable storage (CAS). By providing the capability to backup multiple types of large-scale storage systems, Heartlab is responding to our customers’ need for zero downtime, said Heartlab chief executive officer Robert Petrocelli. Hospitals can use Remote Archive to create an off-line backup of critical cardiology data. If a system failure requires restoration of the enterprise storage system (ESS), the operation can be time consuming. During the data recovery studies on the ESS may not be available. With Remote Archive, prior patient studies can be retrieved from the off-line backup within minutes. It’s a level of protection our customers are asking for. Remote Archive creates a non-proprietary, DICOM-compliant backup disc that can be viewed in any vendor’s DICOM viewing solution. Because no software is required to recover or view the data archived on the DVD-Rs, Remote Archive is a simpler and more efficient recovery solution than tape backup. The system writes dual- or single-layer DVD-R media and incorporates thermal printing technology to print identifying labels on the archive media. Because Remote Archive is a network-attached device, a dedicated computer is not required to host it. CLD

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