AccessClosure, Inc. Marches to the Millionth Mynx!
AccessClosure, Inc., a manufacturer of extravascular closure devices, announced on September 28, 2011, the shipment of its one-millionth Mynx unit. The Mynx Vascular Closure Device received its FDA approval in May 2007, following with its full commercial launch in September 2007. Physician feedback attributes the achievement of this monumental milestone to the fact that the Mynx sealant is extravascular, bio-inert and non-thrombogenic, while leaving nothing behind intra-arterially.
In addition, increased patient comfort continues to resonate with both physicians and nurses as one of their top selection criteria. Results from a recent prospective, randomized study indicate a significant reduction in pain with the Mynx Vascular Closure Device when compared to competitive devices. The study found that 88% of patients find closure to be the most painful part of the procedure when a competitive device was used compared to 34% of patients when the Mynx device was used.
Also contributing to the overall success of Mynx is the continued expansion of its distribution network through international markets; demonstrated most recently with the announcement of the Biosensors International distribution agreement throughout the United Kingdom, Switzerland and France. The Mynx Device is now available through a wide global network of distributors, complementing its direct sales presence in the United States.
For more information, please visit our website at www.accessclosure.com/.
Atrium Announces the Publication of the COBEST Trial by the Journal of Vascular Surgery
Atrium Medical Corporation announced the publication of the COBEST Trial by the Journal of Vascular Surgery. COBEST (Covered Versus Balloon Expandable Stent Trial) was an independent, landmark, prospective, multicenter, randomized, controlled clinical trial that demonstrated that Atrium’s proprietary balloon-expandable covered stent technology is superior to traditional bare metal stents for the treatment of aorto-iliac disease. The journal article, “A comparison of covered vs bare metal stents for the treatment of aorto-iliac occlusive disease,” is currently in press and is also available online at the publisher’s websites, www.elsevier.com or www.sciencedirect.com.
COBEST was the first prospective head-to-head comparison of Atrium’s Vascular V12 balloon-expandable covered stent versus bare metal stents (BMS) for the treatment of aorto-iliac occlusive disease. The study’s principal investigator, Professor Patrice Mwipatayi, MD, is head of vascular surgery at Royal Perth Hospital in Perth, Australia.
COBEST has demonstrated that in TASC B, C, and D iliac lesions, patients implanted with Atrium’s Advanta V12 were more likely to remain free from binary restenosis and had fewer re-interventions than patients with bare metal stents implanted. Upon sub-analysis, Dr. Mwipatayi and the other co-investigators have concluded that Atrium’s Vascular V12 demonstrated the greatest benefit in patients with more complex disease (TASC C & D lesions). There were significantly lower restenosis rates, significantly lower target vessel revascularization (TVR) rates, significantly improved ankle-brachial indices (ABI), and, when these more difficult TASC C & D lesions were analyzed, lower occlusion rates were observed at twelve and eighteen months compared to BMS.
In this study, Atrium’s Vascular V12 has demonstrated higher long-term patency and improved clinical outcomes compared to BMS. COBEST was an independent investigator-initiated study; Atrium Medical had no role in the study design, data collection, data interpretation, or writing of the clinical report. Atrium provided funding for the study, including the employment of a research assistant.
Dr. Mwipatayi has provided this statement regarding COBEST: “This was the first prospective, randomized, multicenter, controlled trial comparing balloon-expandable covered stents directly to bare metal stents. One striking result from the COBEST study was the 5 times lower TVR rate with Atrium’s V12 compared to BMS.”
The Advanta™ Vascular V12 covered stent is a low-profile, pre-mounted covered stent made of a radial expandable stainless steel that is completely encapsulated with Atrium’s patented one-piece covering technology. Atrium’s patented covering technology creates a thermoconformable microporous PTFE layer that completely encapsulates the stainless steel stent.
Covered stents have been shown to exclude plaque and endothelium, thereby potentially mitigating late luminal loss by halting migration and proliferation of vascular smooth muscle cells and inflammatory cells through open stent struts, thus leading to a reduction in restenosis and occlusion rates. With over 125 clinical publications and over 100,000 patients successfully treated worldwide, this latest publication adds to the rapidly growing body of evidence supporting the safety and efficacy of Atrium’s covered stent technology. The V12 covered stent is CE approved for restoring the patency of iliac and renal vessels and is available in diameters of 5 mm to 16 mm. The Advanta™ V12 covered stent is not available in the United States. For more information, visit http://www.atriummed.com/AdvantaV12.
Increasing Cardiovascular Disease In China, Urgent Need For Prevention
At over 40%, the mortality rate due to cardiovascular disease (CVD) in China is amongst the highest in the world1 and has been rightly described as an epidemic. Its population faces a catalogue of CVD risk factor statistics that expose high levels of obesity, diabetes, cholesterol and blood pressure, and a smoking habit within males that is proving stubborn to address.
To support efforts to implement a series of treatment and prevention strategies that can help reverse these worrying trends, the European Society of Cardiology (ESC) delivered an educational program at the 22nd Great Wall International Congress of Cardiology (http://en.gw-icc.org/). The ESC was invited for the second time by its affiliate, the Chinese Society of Cardiology, to co-host a special symposium during the congress, which took place October 15-16, 2011, in Beijing. A senior faculty from the ESC presented a series of practical case discussions jointly chaired with the Chinese Society of Cardiology.
The Chinese Society of Cardiology enjoys excellent relations with the ESC. It hosted a joint scientific session at the 2011 ESC Annual Congress in Paris and also took a stand in the exhibition to promote its activities. Dr. Hu Dayi is a member of the organizing committee of the Great Wall International Congress of Cardiology, now the largest cardiology congress in the Asia Pacific region. “This event has successfully united the various cardiology bodies in China,” he says. “These include the Chinese Society of Cardiology along with the Asia Pacific Heart Association (APHA), the Chinese College of Cardiovascular Physicians (CCCP), and the Chinese Heart Rhythm Society (CHRS). It is a platform for global collaboration, and we plan to extend our cooperation with the ESC in areas such as clinical research, guideline promotion, and training.”
Relevant risk factor statistics2 of the adult population in China highlight the scale of the challenge:
- CVD mortality rates are more than double the typical European value.
- Obesity levels have increased from 21% in 2002 to 36% in 2010.
- Over 30% of the population have high blood pressure and cholesterol.
- Around 50% of males are regular smokers.
- World Health Organization (Department of Measurement and Health Information, 2010)
- World Health Organization (NCD Country Profiles, 2011)
Atrium Medical Agrees to be Acquired by Getinge Group for $680 Million
Atrium Medical Corporation has signed a definitive agreement to be acquired by Getinge Group of Sweden and its subsidiary, Maquet Cardiovascular, for $680 million. Atrium offers medical device technologies for interventional cardiology and radiology, chest trauma care and thoracic drainage, vascular surgery, and general surgery. Atrium will operate as an independent, self-contained business unit of Maquet Cardiovascular and will continue to be led by current Atrium President, Trevor Carlton.
The transaction is expected to close in the fourth quarter of 2011, subject to U.S. Federal Trade Commission (FTC) approval.
SCAI: 10 Tips to Improve Appropriate Use Scores for Elective PCI
AUC Scoring on NCDR CathPCI Reports Prompts a Closer Look at Cath Lab Practices
When cath lab directors began reviewing quarterly reports from the ACC-NCDR CathPCI Registry earlier this year, they might have been surprised to find a new benchmark: the ranking of PCI procedures as appropriate, inappropriate, or uncertain.
Shortly afterward an article appeared in the July 6 issue of the Journal of the American Medical Association (JAMA) showing that, nationwide, about half of elective PCIs reported to the NCDR database could be deemed appropriate when judged against appropriate use criteria (AUC) published in 2009. Another 38 percent fell in to the “uncertain” category, and just under 12 percent were deemed “inappropriate.” (Among patients with acute indications, PCI was considered appropriate nearly 99 percent of the time.)
A wave of negative media coverage followed. Nearly all reports focused on the percentage of inappropriate elective cases. In some instances journalists even lumped “inappropriate” cases together with “uncertain” cases to paint a picture of stent overuse. In September, Consumer Reports joined the fray with a cover story on protecting the heart that included the subtitle “Angioplasty: What your doctor might not tell you.” The article cited both the JAMA study and the high-profile allegations of stent overuse by an interventional cardiologist in Maryland.
“It does seem like interventional cardiologist are a bit in the bull’s-eye these days,” said Gregory J. Dehmer, MD, FSCAI, a SCAI past president and director of cardiology at Scott & White Healthcare in Temple, TX. “We just have to do the best we can to try to educate the public and the media as to what we’re trying to do. The AUC represent an effort on the part of interventional cardiology to make sure we’re always doing things for the right reasons. You don’t see any other professional organization that has gone after this like the interventional community has.”
Also lost in the uproar was acknowledgment that the NCDR considers the new AUC analysis to be a test metric that, by definition, will put cath labs on a learning curve while construct validity and reliability are assessed. Test metrics are not designed for public reporting and should not be viewed as a definitive scorecard on cath lab quality.
“We need tools to help us measure our improvement, and that’s all this is,” said SCAI President Christopher J. White, MD, FSCAI, who is also system chairman for cardiovascular diseases at the John Ochsner Heart & Vascular Institute in New Orleans, LA. “We’re going to be better physicians and better hospitals, and our patients are going to receive better and safer care. It’s just going to be a little bit painful at the beginning.”
The new AUC scoring system represents a clear opportunity for quality improvement on two fronts. In some instances, analyzing cases that are flagged as inappropriate may reveal problems in clinical decision-making that need to be addressed in a systematic way using, for example, the tools available in the SCAI Quality Improvement Toolkit, which can be downloaded from www.SCAI.org/QIT.
In many cases, however, improving AUC scores may simply be a matter of better communication, documentation, and coding. By filling out the NCDR data sheets more completely — and with AUC in mind — hospitals could see a marked reduction in the number of cases ranked as uncertain or inappropriate.
“We have to make sure we give the PCI database the information it needs to accurately refl ect what’s going on,” said Tom Cook, system coordinator for cardiology quality assurance and performance improvement at Ochsner Medical Center. “Communication is number one. Documentation is right behind it.”
SCAI has compiled tips, culled from discussions with a number of SCAI members and their cath lab teams, are likely to help any cath lab to improve its AUC scores.
- Study your NCDR quarterly report. This is the first step to improving AUC scores. Review all cases classified as inappropriate or uncertain to determine why each case was scored the way it was. This type of analysis can be eye-opening, revealing specific targets for improvement at each hospital.
- Know the AUC. In order to earn a good AUC score, it’s important to be familiar not only with the appropriate use criteria but also with the most common reasons cases are classified as inappropriate. In the recent JAMA article, Chan et al found that nearly 89 percent of all inappropriate electiv procedures fell into five clinical scenarios. Just over 82 percent could be described by three scenarios involving, in various combinations, one- or two-vessel disease in combination with few symptoms, a low-to intermediate-risk stress test, and inadequate anti-ischemic medications.
- Re-introduce yourself and your team to the NCDR data forms. Make sure coders understand all of the definitions used in correctly filling out the NCDR data sheets, so that cases are properly categorized. Ask all of the interventional cardiologists in your practice to review the NCDR forms so they know what information the chart abstracter needs. Don’t assume that coders can read between the lines and come up with the correct clinical picture. Some are very experienced and knowledgeable, but others have less expertise — and all are very busy.
- Become class-conscious. It’s important that the pre-procedure work-up or post-procedure case summary includes a clear and concise description of the severity of the patient’s angina, including the Canadian Cardiovascular Society class. “As clinicians we tend to blur the clinical distinction between Class II and Class III, but in the AUC, it makes a big difference,” said James Blankenship, MD, FSCAI, who is chair of SCAI’s Advocacy Committee and director of cardiology at Geisinger Medical Center in Danville, PA.
- Open the medicine cabinet. Be thorough and complete in listing antianginal medications. This can nudge a case from the uncertain category into the appropriate category by showing that the patient is on maximal medical therapy. Specify whether the patient is taking long-acting nitrates, beta blockers, and/or calcium-channel blockers.
- Embrace the stress test. The results of noninvasive testing should be stated concisely and clearly. It’s not enough to say the test was positive, negative, or indeterminate. Also indicate whether there is a low, moderate, or high likelihood of future ischemic events.
- Let the outside in. Many patients are referred for PCI after having an initial clinical work-up elsewhere. Information on noninvasive stress testing, medications, and clinical history could be housed at another hospital, physician’s office, or imaging center. It’s essential that this information be included in the cath lab’s records and be available to chart abstracters. Otherwise, the NCDR data sheets will be incomplete.
- Multitask during PCI. No one likes to finish a case and then sit down to fill out a long form. Instead, assign a tech to fill out the NCDR form during PCI, taking advantage of pauses in the action to clarify questions such as percent stenosis or patient risk level. “There are always slow spots, such as when a balloon is deflating,” Dr. Blankenship said. “And the information is never more readily available than during the case.”
- When in doubt, turn to FFR. When angiography reveals a stenosis of 70 percent or less, it’s important to document the lesion’s clinical significance. Inclusion of flow reserve (FFR) ratios helps to do that. This is particularly true if the results of noninvasive stress testing are indeterminate or missing.
- Get the word out. Once you’ve identified the key steps your cath lab should take to improve AUC scores, spread the word. Use a variety of tools, including wall posters, checklists, and cath lab protocols. Incorporate reminders into the electronic medical record if possible.
Interventional cardiologists ultimately hold the key to improving AUC scores, stressed Dr. White. “Physicians have to be responsible for the quality of the data that’s recorded. You have to take ownership of that. You can’t expect your coders to save you.” At the same time, no one expects all cases to ranked as appropriate.
“Everybody is going to wind up having a few cases that, by the criteria that now exist, are going to be adjudicated as inappropriate,” Dr. Dehmer said. “That doesn’t mean it was bad medical care. It just reflects the limitations of the AUC. Clinical medicine has so many twists and turns, you can’t pigeonhole every case.”
Reprinted with permission from the Society for Cardiovascular Angiography and Interventions (SCAI). Learn more at www.scai.org.
SCAI: Changing Environment Poses New Challenges for Interventionalists
Thomas Tu, MD, FSCAI
Much has changed in interventional cardiology since I completed my fellowship in 2002. Back then most of us were primarily coronary interventionalists. Drug-eluting stents (DES) were newly approved, and the idea of 60- to 90-minute door-to-balloon times was still a distant goal. Peripheral interventions were only beginning to interest us, and only busy cath labs might have had a single person performing valvuloplasty and early atrial septal defect (ASD) closure.
Percutaneous coronary intervention (PCI) volume was increasing annually, as were advances in scientific discovery and drug/device development. We envisioned helping an increasing number of patients in ways our specialty’s founders could not have imagined.
Today, the tools we use have improved, enabling us to treat more complex disease, but the decision making has become more complicated. The challenging global economy is draining money away from healthcare and medical research. Coding and billing issues are becoming as important to our livelihood as the technical aspects of performing successful interventions. Doctors are making headlines for all the wrong reasons, amid allegations of conflict of interest and inappropriate interventions.
In less than a decade, the bright future we forecasted changed dramatically, altering the professional landscape for all of us. These changes can be both dizzying and frightening. It helps to examine some of the trends that will influence our careers at least over the next few years.
Hospital-Owned and -Affiliated Employment
When I started my career, most cardiologists were self-employed, often small business owners. Changes in reimbursement and fears over further erosion of physician income have pressured most independent cardiologists to seek financial relationships with their hospital networks.
I predict more than 80 percent of cardiologists will be affiliated with a hospital by year’s end. This may be contrary to our natural tendencies toward independent thinking and quick decision making, but it doesn’t have to result in conflict. In fact, working in partnership with a hospital network may help us accomplish bigger goals, such as system-wide improvements in access and quality of care.
Tip: Get to know hospital administrators, and have patience when working with them. They need us as much as we need them.
Declining PCI Volume and Reimbursements
Every year we get paid less, despite providing increasing levels of care. PCI volumes are static or declining due to a combination of factors, including better preventive care, reduced restenosis, and increasing interest in medical management of chronic stable angina.
Tip: Distinguish yourself from your peers in your community through patient outreach, excellent customer service, and unique services such as transradial, structural, or peripheral procedures.
Tip: Support our profession by participating in the societies that represent us, such as the SCAI and ACC. Only through organization and cooperation can we influence policymakers and funders to support our positions.
Conflicts Over Appropriateness of PCI
Angioplasty has come full circle in the eyes of the public and some of our colleagues. What recently was hailed as the mainstay treatment for coronary artery disease is now assailed by some as expensive, overused, and potentially dangerous. Our judgment is being called into question by a small but vocal number of colleagues and by the media.
Meanwhile, we have better technology and data to guide our decision making than ever before. Noninvasive assessment of coronary ischemia continues to improve; angiographic image quality is vastly superior to the days of film; and advanced techniques such as FFR, IVUS, and OCT allow us to make better-informed decisions about which patients will benefit from intervention.
Tip: Accept that the future will bring more scrutiny of what we do, how we do it, and how much it costs. Have strong justification for each procedure you perform, and document it. In borderline cases, use additional imaging or functional studies to provide rationale for treatment strategies.
Internationalization of Cardiology
Historically, many advances in interventional cardiology have been conceptualized and developed in the United States and Europe, but research and technology investments are shifting as U.S. healthcare expenditures plateau or decline and as the incidence of cardiovascular disease grows globally.
Tip: Seek opportunities to draw on the experiences of colleagues in Asia, Latin America, and Australia.
Many of my senior colleagues grumble about the passing of “the good old days.” Having never seen them firsthand, I’m not sure exactly what I’m missing, but I do know that change is inevitable. The experience may be upsetting, but it also represents an opportunity to improve ourselves and our profession. One thing I know: there will always be room for thoughtful, compassionate doctors who perform procedures well and take good care of patients.
Dr. Tu is the director of the cardiac catheterization laboratory at Louisville Cardiology Group, Baptist Hospital East, in Louisville, KY. He is the co-chair of SCAI’s Interventional Career Development Committee, a SCAI-ELM Fellow, and the founder of World Health Initiative, a charitable organization.
Reprinted with permission from the Society for Cardiovascular Angiography and Interventions (SCAI). Learn more at www.scai.org.
Experimental IV Solution Could Minimize Tissue Scarring After MI
A new treatment could revolutionize the treatment of patients after a heart attack. Hendrik Jan Ankersmit from the Medical University of Vienna has developed a protein solution that can be used to reduce the scarring of tissue caused by inflammation after a heart attack.
Following the usually critical first phase of a heart attack, intensive rehabilitation is carried out and there is a risk of heart failure. The results of the research carried out by Hendrik Jan Ankersmit, head of the CD Laboratory for Heart and Thorax Diagnosis and Regeneration at the MedUni Vienna, show that this need no longer be the case. Ankersmit has used white blood cells to create a protein solution (Aposec™) that can be used as a drug during the acute therapy phase following a heart attack. In laboratory tests, the solution was administered as an intravenous infusion 40 minutes after an experimental infarction. As a result, there was virtually no scarring of the heart muscle.
Aposec works by inhibiting the cardiac tissue’s inflammatory response following a heart attack. Tests on human cardiac muscle cells — with highly promising results — have already been carried out in vitro. Researchers at the MedUni Vienna are hoping to start a series of clinical studies on humans in the near future.
Aposec contains soluble proteins that are excreted by white blood cells. Harvesting white blood cells for use as ‘bio-reactors’ is as simple as taking blood. “With protein concentrates, there is little or no defense reaction from the body’s immune system. Aposec can therefore be obtained even from unrelated donors,” says Ankersmit.
An even greater potential advantage over the conventional stem-cell-based treatment of myocardial infarctions is that the Aposec protein solution can be produced in advance and stored for ready access, just like blood in a blood bank. In the event of an acute infarction, the patient can be treated immediately.
- Lichtenauer M, Mildner M, Hoetzenecker K, et al. Secretome of apoptotic peripheral blood cells (APOSEC) confers cytoprotection to cardiomyocytes and inhibits tissue remodelling after acute myocardial infarction: a preclinical study. Basic Res Cardiol 2011, Sep. 28.
SCAI: Next Generation of Interventional Cardiology Leaders Announced
The Society for Cardiovascular Angiography and Interventions (SCAI) announced the selection of 10 emerging interventional cardiology leaders to participate in the Emerging Leader Mentorship (ELM) Program. Sponsored by SCAI, and co-sponsored by the American College of Cardiology and the Cardiovascular Research Foundation, these leaders will train in an intense, two-year mentorship program to improve and refine their skills as future ambassadors of the field.
In a time of more advanced technologies, stricter regulations, increased clinical demands and fewer resources for professional growth and scholarship, pioneers in the specialty have expressed a need to nurture a new generation of leaders to confront today’s challenges and prepare for what lies ahead. In its inaugural year, the ELM program is designed to thoughtfully and comprehensively address this need and foster professional growth and leadership opportunities for interventional cardiologists three to ten years out of training. This year’s Emerging Leaders were carefully selected by a steering committee from a group of 62 applicants. They are adult and pediatric interventional cardiologists with great leadership potential who are motivated to excel both regionally and nationally in the areas of clinical care, scholarship, education and political advocacy.
“In this rapidly changing field, it is absolutely essential to ensure promising young physicians have the opportunities and mentorship available to keep our specialty innovative and our pipeline filled with active and engaged leaders,” said Srihari S. Naidu, MD, FSCAI, ELM program chair and director of the cardiac catheterization laboratory at Winthrop University Hospital in Mineola, NY. “This unique program will help guide relatively new interventional cardiologists to become respected leaders in the field both regionally and nationally, and will foster participants’ careers to achieve both personal and field-wide success.”
ELM participants will first be connected with a mentor in the same geographic region who shares similar professional goals. Together, they will craft individualized career development plans and meet on a regular basis to see career plans through, discuss challenges and revisit goals and strategies to attain them. ELM participant progress will be tracked actively by the program committee to gauge and ensure success. ELM participants will also receive group training about pertinent topics for leaders such as team building, health reform, public speaking, time management and industry relations, among others.
Each class of ELM participants will meet annually at SCAI’s annual meeting and other society annual meetings throughout the year to receive advanced group training on topics such as advocacy techniques and practice management. ELM participants will be encouraged to, and assisted with, finding opportunities in professional society committees and at scientific meetings to continuously develop presentation skills, foster relationships, keep up-to-date on emerging trends and develop their professional niche.
“There is unbelievable potential in our physician pipeline. The ELM program will work to enhance the future of this pipeline and the field of interventional cardiology,” said Christopher J. White, MD, FSCAI, SCAI president. “We are looking forward to watching these 10 members flourish professionally during their time in the program and also long after they complete the program.”
The 2011-2013 ELM class includes:
- J. Dawn Abbott, MD, FSCAI, Director, Interventional Cardiology Fellowship Program, Division of Cardiology, Rhode Island Hospital, Providence, Rhode Island
- Mauricio Cohen, MD, Director, Cardiac Catheterization Laboratories, Division of Cardiology, University of Miami – Miller School of Medicine, Miami, Florida
- Douglas Drachman, MD, FSCAI, Director, Cardiology Fellowship Program, Division of Cardiology, Massachusetts General Hospital, Boston, Massachusetts
- Allen Jeremias, MD, Director, Vascular Medicine and Peripheral Intervention, Division of Cardiology, Stony Brook University Medical Center, Stony Brook, New York
- Navin Kapur, MD, FSCAI, Assistant Director, Cardiac Catheterization Laboratories, Division of Cardiology, Tufts Medical Center, Boston, Massachusetts
- Lynn Peng, MD, Clinical Assistant Professor of Medicine, Division of Pediatric Cardiology, Lucile Packard Children’s Hospital, Stanford, California
- Duane Pinto, MD, Director, Cardiovascular Fellowship Program, Division of Cardiology, Beth Israel – Deaconess Medical Center, Boston, Massachusetts
- Paul Sorajja, MD, FSCAI, Associate Professor of Medicine, Division of Cardiology, Mayo Clinic, Rochester, Minnesota
- Jennifer Tremmel, MD, Clinical Director, Women’s Heart Health, Division of Cardiology, Stanford University Medical Center, Stanford, California
- Thomas Tu, MD, FSCAI, Director of the Cardiac Catheterization Laboratory, Louisville Cardiology Medical Group, Louisville, Kentucky
New Registry to Measure Clinical Outcomes and Disease Management of Jetstream Atherectomy System
Multi-center, open-label study will follow 500 patients undergoing percutaneous intervention for PAD
Pathway Medical Technologies, Inc., a wholly owned subsidiary of Medrad, Inc. – a Business of Bayer Healthcare, announced initiation of the JET Registry, a national registry focused on tracking patients with symptomatic peripheral arterial disease (PAD) undergoing percutaneous intervention. The JET Registry will enroll up to 500 patients at approximately 75 clinical sites across the United States. Patients will be followed for up to one year post treatment. The first patient was enrolled this month with Dr. Vinay Kumar at South Central Regional Medical Center in Laurel, Mississippi.
The JET Registry is a prospective, multi-center, open-label study that will evaluate clinical outcomes, including long-term patency, Rutherford/ABI scores, stent use, measurement of the amount of calcium removed during treatment, as well as major adverse events (MAEs) of patients treated with the Jetstream System. The primary objective of the Registry is to provide clinicians with critical data and insights on disease management, treatment effectiveness and patient outcomes following intervention. Additionally, patients will be able to provide feedback on their treatment satisfaction and its impact on their quality of life.
The principal investigators for the JET Registry are William A. Gray, MD, Director of Endovascular Services, Center for Interventional Vascular Therapy at New York-Presbyterian Hospital in New York, NY, and Christopher J. Kwolek, MD, Director of Endovascular Training for the Division of Vascular & Endovascular Surgery at Mass General Hospital in Boston, Massachusetts and Assistant Professor of Surgery at Harvard Medical School. Additionally, Michael Jaff, DO, Medical Director of the Vascular Ultrasound Core Laboratory and Associate Professor of Medicine at Harvard Medical School, will participate in the independent analysis for this registry.
“Our goal with the JET Registry is to provide interventionists with a central repository for information about patient and disease response to less invasive percutaneous interventions for PAD,” said Dr. Gray. “There is a growing body of published research suggesting that PAD patients can benefit from non-surgical treatment options and have positive outcomes with shorter recovery and fewer side effects. Ultimately, we believe the Registry will be an effective tool that produces scientific data that may help aid clinicians in the treatment decision-making process for PAD sufferers.”
Enrollment in the JET Registry is open to patients eligible for treatment with the Jetstream System who meet the criteria for study inclusion. Additional information about eligibility requirements and exclusions can be found at: http://clinicaltrials.gov/ct2/show/NCT01436435.
The JET Registry will be approved by the Institutional Review Board (IRB) of each participating organization and is supported by a Steering Committee that will provide guidance on clinical issues, including data interpretation and analytics reviews. Medrad and Pathway plan to publish data from the registry on an ongoing basis.
Jetstream is a peripheral revascularization catheter consisting of a sterile, single-use catheter and control pod, and a reusable, compact console that mounts to a standard IV stand. The catheter has a cutting tip that safely debulks and preemptively removes both hard and soft plaque, as well as calcium, thrombus and fibrotic lesions. Excised tissue and thrombus are continually aspirated from the peripheral treatment site through a port in the catheter tip to a collection bag located on the console. Active aspiration is a safety feature that minimizes the risk of distal embolization. The distal portion of the catheter also possesses infusion ports that provide continuous infusion of sterile saline during the atherectomy procedure.
For further information, visit the company’s website at www.pathwaymedical.com.
Cath Lab Digest Launches iPad, Android OS Editions
Cath Lab Digest is pleased to announce the launch of a digital-tablet edition (available via apps for Android devices and the iPad). Digital subscribers will receive their issues the same day CLD mails — before magazines hit mailboxes. The CLD app will deliver the practical clinical content of the print edition, along with video content, in-text web links that can be browsed simultaneously, and interactive advertising.
Readers need only search Apple’s App Store or the Android Marketplace for “Cath Lab Digest” to download. According to recent studies, about 20% of U.S. physicians were using the iPad alone by the end of 2010.1 CLD publisher HMP Communications polled cardiology clinician readers of CLD and found 37% preferred to read medical publications on their tablets. Further, 17% say they plan to buy a tablet computer in the next 6 months, and 43% in the next year.
“Cath Lab Digest readers are busy, and need information when they want it and how they want it,” said Jeff Martin, group publisher of the cardiology division of HMP Communications. “Adding tablet apps for CLD addresses readers’ needs — and enhances the ways in which clinical and product information can be delivered. This interactivity is the future of medical publishing, and CLD is on the leading edge.”
- Available from http://chilmarkresearchstore.com/mhinentropch.html. Accessed August 31, 2011.
HMP Communications, LLC, is a leader in healthcare communications and education. The company publishes some of the nation’s most well-respected journals across three key medical divisions: Wound Care/Podiatry, Cardiology and Life Sciences. HMP also offers more than 20 years’ meeting management/production expertise and over a decade producing cutting-edge, online education. Visit www.hmpcommunicationsholdings.com for more information.
InfraReDx Announces Data Demonstrating the LipiScan™ Coronary Imaging System Detects Extensive Lipid Core Plaques Linked to a High Risk of Peri-Procedural Heart Attacks
Study Shows Lesions with Large Lipid Core are Associated with 50 Percent Risk of Heart Attack in Patients Undergoing Coronary Stent Implantation
InfraReDx, Inc. announced that new data for its LipiScan™ Coronary Imaging System was published in Circulation: Cardiovascular Interventions. Near-infrared spectroscopy (NIRS) with the LipiScan system was shown to rapidly and accurately detect extensive lipid core plaques (LCPs) that are linked to an increased risk of heart attack during or following percutaneous coronary intervention (PCI). The LipiScan system is approved by the U.S. Food and Drug Administration to provide interventional cardiologists with a Chemogram™, a two-dimensional map of LCP, within the imaged vessel using NIRS.
“Although PCI routinely achieves excellent angiographic results, too many cases continue to suffer from peri-procedural no-reflow and myocardial infarction,” said James A. Goldstein, MD, FACC, director of research and education, division of cardiology, Beaumont Hospital, Royal Oak, and lead author of the study. “This study utilizing InfraReDx’s first-generation LipiScan system with NIR spectroscopy permitted immediate identification of large lipid core plaques known to complicate stenting and suspected to cause most heart attacks. By identifying and quantifying these dangerous plaques that are prone to embolization, the LipiScan system holds the potential to improve patient outcomes and prevent complications in cardiac procedures.”
PCI is associated with a peri-procedural heart attack in three to 15 percent of cases. The published study shows that in patients with coronary artery disease, PCI of lesions with a large lipid core is associated with a 50 percent risk of heart attack during or post-procedure, compared to only a 4.2 percent risk for lesions without a large lipid core. A large LCP was defined as a maximum lipid core burden index (LCBI) within a 4mm segment of ≥500, which corresponds to a LCP which on average is 4mm long and occupies 180° of the vessel circumference. Sixty-two patients meeting study criteria were selected from the COLOR Registry (NCT00831116). There were no major adverse events attributed to the use of the LipiScan system.
The use of NIR spectroscopy with the LipiScan coronary imaging system permitted the immediate identification and quantification of LCPs whose presence could not be determined by coronary angiography. Baseline variables also correlated poorly with the presence of a large LCP, with elevation of plasma LDL levels as the only statistically significant association. Patients with a large LCP had a 12-fold increase in relative risk (95% CI 3.3 to 48, p=0.0002) of peri-procedural heart attacks. In contrast, plaque complexity identified on coronary angiography, a finding often considered to be an index of increased risk of a PCI-induced complication, was associated with a relative risk of only 3.5 (CI 0.91 to 14), a difference that was not statistically significant.
Results of the published study are consistent with prior findings with other intracoronary imaging methods, but the LipiScan system identified a much higher relative risk and requires no offline analysis or expert interpretation. These findings support the concept that LCPs may be prone to complications after stenting, and their detection in the cath lab prior to angioplasty may help guide the interventional treatment strategy. As stated in the study article, “the ability to identify stenoses with varying levels of risk of complications when stented would indicate that LCP presence or absence might play a role in determining whether or not a lesion should be treated.”
The paper, “Detection of Lipid-core Plaques by Intra-Coronary Near-Infrared Spectroscopy Identifies High Risk of Peri-Procedural Myocardial Infarction,” was published online at http://circinterventions.ahajournals.org/content/early/2011/10/04/circinterventions.111.963264.abstract.
Study methodology. Patients with stable pre-procedural cardiac biomarkers undergoing stenting were identified from the COLOR Registry, a prospective multi-center observational study of patients undergoing near-infrared (NIR) spectroscopy with the LipiScan coronary imaging system prior to PCI. The primary endpoint of the published study was the rate of peri-procedural heart attack in the groups with and without a large lipid core plaque (LCP) in the treatment zone as assessed by NIRS and expressed as maxLCBI(4mm). The maximum value of Lipid Core Burden Index for any of the 4 mm segments in the treated segment is calculated and used as the index of the presence or absence of a large LCP in the treated area.
Since this study was performed using the LipiScan coronary imaging system, InfraReDx received clearance from the U.S. Food and Drug Administration (FDA) and CE Mark approval for its next-generation product, the LipiScan IVUS Coronary Imaging System. The system includes a cardiac catheter to combine intravascular ultrasound (IVUS) and near-infrared (NIR) spectroscopy. In a single catheter pullback, the LipiScan IVUS provides physicians with a traditional IVUS image that clearly displays key structural parameters of the lesion, including its location, length, degree of stenosis, and plaque burden in addition to confirming proper stent placement. At the same time, the system automatically performs spectroscopic analysis of optical data to produce a Chemogram map that indicates the location of lipid core plaques and quantifies the lipid core burden. The system requires no post-processing or image manipulation.
InfraReDx recently initiated CANARY (NCT01268319), a prospective, multicenter, randomized trial designed to test the hypothesis that NIRS-guided use of an embolic protection device during percutaneous coronary intervention can reduce the rate of peri-procedural heart attack in patients identified as having large, high-risk LCPs. The study is being conducted using the company’s LipiScan IVUS system.
For more information, visit www.infraredx.com.
James A. Goldstein, MD, is a consultant for and owns equity in InfraReDx, Inc.