Clinical and Industry News

NEWS

Vascular Solutions Introduces New Muskie™ 0.014” Guidewires

Vascular Solutions, Inc. recently launched its new Muskie line of 0.014” guidewires. Muskie guidewires offer a range of distal tip stiffness that allow physicians to select an appropriate guidewire for crossing highly stenosed lesions. Muskie guidewires have a one-piece core construction that is designed to transfer torque from the proximal portion of the guidewire to the distal tip, which allows precise control. The Muskie guidewires are available in lengths of 195 cm or 300 cm with five options for tip stiffness — 3g, 4.5g, 6g, 9g, and 12g — providing physicians with multiple options for accessing challenging lesions. The Muskie line of guidewires are intended for use in the coronary or peripheral vasculature, and are currently available for sale in the U.S. ____________________________

Paramedic Team Initiates Combined Cutting-Edge “Cooling” Therapy With Resqpod™ and EZ IO™ Heart Attack Devices At The Scene — Saving Time and Saving Lives

Saints Medical Center (Lowell, MA) paramedics, also known as “Greater Lowell EMS” are the first 911 Advanced Life Support (ALS) medics in Massachusetts to offer a new combination of potentially lifesaving treatments at the scene of a sudden cardiac arrest in the community. Saints paramedics now bring “therapeutic hypothermia,” the RESQPOD™ threshold impedance device and the EZ IO™ intraosseous vascular access device to life-threatening cardiac emergency events, increasing the chances of survival and improving the functional outcomes of those who survive. In January 2009, Saints introduced the first paramedic-initiated therapeutic hypothermia program in the region, starting the life- and brain-saving cooling process right out in the field, at the earliest possible time. The therapy uses a combination of external cooling and internal cooling with chilled intravenous (IV) saline infusions. Previously, this therapy was induced when the patient arrived at the Medical Center. Research indicates that those who receive the earliest therapeutic hypothermia treatment have the best chance of surviving a sudden cardiac arrest and retaining the best brain possible function. Saints paramedics are also using the Resqpod, a small device that is attached to the breathing tube placed by paramedics into the windpipe of a patient in cardiac arrest. The device creates a vacuum effect on blood vessels in the chest and helps to draw life-sustaining blood into a stopped heart as it is being pumped artificially by CPR. The third weapon in their arsenal, the EZ IO device, allows Saints paramedics to insert a catheter directly into the bone marrow of a critically ill patient’s shin, ankle or shoulder bones with a special medical drill. Once inserted, the EZ IO allows paramedics to rapidly infuse lifesaving fluids and drugs. In several cases, the EZ IO has enabled Saints paramedics to make the critical difference in saving the lives of patients with collapsed veins from poor heart function or massive blood loss. These are situations where establishing standard intravenous access may be delayed or impossible. Saints paramedics are the first to deploy the EZ IO device in the field in the Greater Lowell area and the Saints Emergency Department physicians also utilize the EZ IO when necessary. Combining the EZ IO and Resqpod with better CPR and other new treatments such as therapeutic hypothermia, offers the best chance for improving survival and functional outcome. To provide therapeutic hypothermia, Saints paramedics chill several intravenous (IV) fluids to 4 to 5 degrees Celsius in portable temperature controlled medical coolers that have been installed on the Saints rapid response medic units. “Once the Saints paramedics initiate therapeutic hypothermia care in the field, the patient then flows through our fully integrated emergency department, cardiac catheterization lab and intensive care unit,” added Erin Boutin, RN, Saints cardiac catheterization laboratory manager. “We work as one team committed to the patient’s best outcome.” In 2007, Saints instituted the first in-hospital therapeutic hypothermia protocol in the Merrimack Valley. It was quickly put to work when the Saints therapeutic hypothermia protocol saved the life of Tyngsboro resident Biharibhai Patel. “We can save lives because the paramedics recognize a heart attack out in the field and activate the critical care team at the hospital,” said Kirk MacNaught, MD, interventional cardiologist at Saints. “We are called in and ready when the patient arrives. In that sense, we are ahead of the curve.” Established in 1983, Saints paramedics were the first ALS team in the Merrimack Valley. The Saints strategy for increasing survival and promoting best outcomes from sudden cardiac arrest is in accordance with the most current recommendations of the American Heart Association and other sudden cardiac arrest survival efforts, such as the Take Heart America program. ____________________________

Steris Corporation and Siemens to Develop Hybrid Surgical Suites

Steris Corporation, focusing on surgical support and integration technologies, and Siemens Medical Solutions USA, Inc., have agreed to collaborate to offer optimized vascular, cardiovascular and neurosurgical hybrid surgical suites. Through this collaboration, Siemens will provide information and interventional technologies, while Steris will supply custom-designed HD 360 degree suites featuring LED surgical lighting and visualization systems, as well as OR integration and equipment management solutions. Steris will also provide expert room design and project management services using the company’s three-dimensional Room Builder software. The hybrid suites that result from these joint efforts will enable surgical and diagnostic teams to carry out a vast range of image-guided cardiovascular, vascular, and neurosurgical interventional procedures as well as open surgeries. ____________________________

Society News

Development Begins for Board Review Courses and Training Workshops on Medical Simulators

ISMIPSI Holds Their Planning Committee for 2009-2011 Conferences in Evanston, Illinois On Friday, May 29, 2009, the Conference Planning Committee of the International Society of Advanced Level Medical Imaging Physician Specialists, Incorporated (ISMIPSI) held a meeting to begin the development of board review courses and training workshops on medical simulators designed for cardiovascular procedures. The members of the planning committee were: • Tim Shannon, President, Mentice Corporation, Evanston, IL; • Jeff Davis, RRT, RCIS, Director, CVT Program, Edison State University, Ft. Myers, FL; • Marsha Holton, RN, CCRN, RCIS, Cardiovascular Orientation Programs, Indian Head, MD, Instructor, CVT Program, Howard Community College, Columbia, MD; • Michael Guiry PA-C, Chief PA, Cardiovascular Services, Columbia Medical Center, New York, NY; • Neil Holtz, RCIS, EMT-P, COO-Society; • Tressie Brooks, RN, Chairperson, Membership Committee-Society; • Julie Logan, RN, COO, Foundation for Cardiovascular Medicine, La Jolla, CA; • Chuck Williams, CFO-Society; • Dana Rigdon, CMP, Executive Director, South Louisiana Clinical Research Foundation, Lafayette, LA. An overview of the 10th Annual New Cardiovascular Horizons Conference and the partnership with the Society was discussed. In addition, the mechanism of offering a training workshop on medical simulation designed for cardiovascular studies was a major topic. The committee made a decision to create an introductory program on medical simulation at the 10th Annual New Cardiovascular Horizons (NCVH) conference, Roosevelt Waldorf Astoria Hotel, New Orleans, Louisiana, on July 9-11, 2009. The committee and the clinical specialist team with Mentice Corporation discussed the logistics of the introductory program at NCVH. The agenda included measurable learning objectives, roles of team members, criteria assessment for participants, determination of session case and preparation of a format for the post-event evaluation. The members of the committee discussed the support needs and logistics of providing future training workshops. These workshops would lead into formal accredited certification on medical simulators designed for cardiovascular procedures. Preparation for accredited certification includes identification of proctors to identify and assess participants, methods of scheduling participants for training on simulators and a forecasted budget. The case for this year’s session has been finalized. In addition, the committee agreed to write the “Handbook for Training of Cardiovascular Medical Specialists and Cardiovascular Specialist Assistants on Medical Simulators Designed for Cardiovascular Studies” with a target completion date of November 30, 2009 so the handbook would be available January 1, 2010 at a nominal fee plus shipping and handling. Also, the committee has begun the process of developing board review courses and medical simulation workshops, to be presented on a quarterly basis in New Orleans and Chicago. The International Board of Credentialing Cardiovascular Specialists and Cardiovascular Specialist Assistants will be incorporated on August 1, 2009. This new credentialing agency will provide the “hands-on” (oral) examinations on medical simulation and written examinations for certification as Registered Cardiovascular Specialists (RCS) and Registered Cardiovascular Specialist Assistants (RCSA). The initial certification process for Medical Cardiovascular Specialist Assistants and Cardiovascular Specialists will be scheduled to begin in Chicago in July 2010. Additional testing centers will be setup in New Orleans, LA and Ft. Myers, FL, where additional medical simulators will be located. The team discussed the accreditation of the seminars. The accreditation process will be formally handled through the South Louisiana Clinical Research Foundation (www.slcrf.com) and the Cardiovascular Institute of the South. The current conference has been accredited by the Accreditation Council for Continuing Medical Education, which is comprised of the American Board of Medical Specialties, American Hospital Association, American Medical Association, Association for Hospital Medical Education, Council of Medical Specialty Societies, Federation of State Medical Boards of the US, Inc. and Association of American Medical Colleges. Lastly, the writing committee for the Society has begun development of “The Proposed Core Curriculum for Training of Cardiovascular Medical Specialists and Cardiovascular Specialist Assistants on Medical Simulators Designed for Cardiovascular Studies,” which will be submitted for publication on December 1, 2009. The Planning Committee will meet in Chicago in early December 2009 to finalize plans for 2009-2011 and to review the “Handbook of Training” prior to being formally printed. For further information, please contact Dana Rigdon at Dana.Rigdon@slcrf.com; Neil Holtz at coo@ismipsi.org, or Chuck Williams at cfo@ismipsi.org. ____________________________

Clinical and Industry News

Abbott Announces Launch of Next-Generation Embolic Protection System, Emboshield NAV6™

Abbott announced the launch of the sixth-generation Emboshield NAV6™ Embolic Protection System for use in carotid artery stenting procedures. The Emboshield NAV6 is now available in the United States and Europe. Abbott’s proprietary BareWire™ technology allows for wire movement independent of the Emboshield NAV6 filter, giving physicians an increased level of control during carotid stenting procedures. “The innovative design of the Emboshield NAV6 offers marked improvements to an already good embolic protection system. It provides excellent steerable wire options to independently reach challenging lesions, a short basket length, significantly improved visibility, an easier-to-use retrieval system, and optimal pore size and distribution,” said D. Christopher Metzger, MD, FACC, of the Holston Valley Medical Center, Kingsport, Tenn. Safety and efficacy endpoints for the Emboshield NAV6 were met in Abbott’s PROTECT clinical trial, which was designed to examine carotid artery stenting with Abbott’s Emboshield systems in patients at high risk for carotid endarterectomy. In addition to demonstrating continued improvements in outcomes for carotid stent procedures, the PROTECT study data showed a low 1.8 percent composite rate of all stroke and death at 30 days in 220 patients. This rate is well within American Heart Association (AHA) 30-day all stroke and death rate guidelines for carotid endarterectomy of 6 percent for symptomatic and 3 percent for asymptomatic patients with carotid artery disease. The PROTECT study results were presented at the Transcatheter Cardiovascular Therapeutics conference in Washington, D.C., in October 2008. “As a member of the PROTECT multispecialty Executive Committee, I have been impressed with the continuing downward trend in stroke rates with protected carotid stenting for patients at high risk for carotid endarterectomy from the earliest clinical trials with first-generation devices 10 years ago,” said Jon S. Matsumura, MD, professor of surgery, University of Wisconsin School of Medicine and Public Health. “These results are related to several factors, including process of care improvements that skilled physicians are developing, and to the continuing improvements in device technology.” ____________________________

Merit Medical Acquires EN Snare® Product Rights From Hatch Medical

Merit Medical Systems, Inc. a manufacturer and marketer of proprietary disposable medical devices used in interventional and diagnostic procedures, particularly in cardiology, radiology and gastroenterology, announced that it has acquired intellectual property, including patents, certain trademarks and know-how, associated with the EN Snare® foreign body removal device from Hatch Medical, L.L.C. The EN Snare device is used by physicians for retrieval and removal of stents, vena cava filters and embolic coils as well as the manipulation of AAA stent grafts and guidewire “pull-throughs.” A third party currently manufactures and distributes the EN Snare® product line. Merit intends to exclusively manufacture and distribute the products worldwide beginning early January 2010. Until then, Merit will receive royalties for units sold by the third party. According to IMS data, the average sales price for the EN Snare is $330.00. ____________________________

Volcano Announces Worldwide Exclusive Distribution Agreement With Lumen Biomedical for Xtract™ Thrombus Aspiration Catheter

Volcano Corporation announced an exclusive worldwide distribution agreement to initiate the formal launch of the Xtract™ thrombus aspiration catheter, manufactured by Lumen Biomedical. The Xtract thrombus aspiration catheter is available for immediate sale in the U.S. and Europe. The Xtract thrombus aspiration catheter has been cleared by the FDA and is CE marked for use in coronary vessels, as well as some peripheral vascular applications. The device incorporates three design attributes. These include a single lumen design to maximize cross-sectional area, and in turn, thrombus suction; a circular, right angle tip for close-up access to clots; and a curved, directional tip to enable full sweep of the vessel. Jim Margolis, Director, Cardiovascular Research and Education, Miami International Cardiology Consultants, commented, “We have been using the Xtract catheter at Jackson Memorial Hospital since October 2008. In my view, compared to other thrombectomy catheters I have used, this device is in a generation of its own. It tracks better, removes an order of magnitude more debris, and resists kinking. Because of its ease of use and effectiveness, some of us have begun using it on non-STEMI patients as well as STEMI patients.” ____________________________

SPIRIT V One-Year Data: Safety and Efficacy Rates in Patients with Challenging Anatomy Consistent with Superior Results from RCTs

New data presented at the May 2009 EuroPCR from an international, post-approval, single-arm study show that Abbott’s Xience V® Everolimus Eluting Coronary Stent System demonstrated low rates of repeat procedure (target lesion revascularization), stent thrombosis and major adverse cardiac events (MACE) in a complex patient population. In the SPIRIT V (five) study, Xience V demonstrated a very low 1.8 percent rate of target lesion revascularization (TLR), a 0.7 percent rate of stent thrombosis and 5.1 percent rate of MACE at one year. The SPIRIT V study evaluated Xience V in a diverse, “real world” population of patients and lesion types, including diabetics, patients with multi-vessel disease and patients with highly complex lesions. It is an international, post-approval study of 2,663 patients. Eberhard Grube, MD, chief, Dept. of Cardiology and Angiology, Heart Center Sieburg, Germany and principal investigator of the SPIRIT V study, said, “The one-year results indicate that even in a patient population with a high percentage of complex lesions, XIENCE V exhibits remarkably low event rates, similar to what was seen when Xience V was studied in controlled, randomized SPIRIT studies.” The primary endpoint of the study is a composite rate of all death, myocardial infarction and target vessel revascularization at 30 days, in which Xience V had a rate of 2.7 percent. All events were adjudicated according to the Academic Research Consortium (ARC) definitions by an independent Clinical Events Committee. The safety and efficacy of Xience V has not been established in the United States for patients with multi-vessel disease, patients with highly complex lesions (lesion type B2 or C), or patients with severely calcified lesions. Abbott’s next-generation drug-eluting stent in development, the Xience Prime™, utilizes the same drug and polymer as XIENCE V and is based upon the proven design of the Multi-Link® family of stents. Xience Prime will be available in an expanded size matrix, including Xience Prime SV for small vessels and Xience Prime LL for long lesions. Xience Prime is pending CE Mark and is not available for sale. ____________________________

Chemical Found in Medical Devices Impairs Heart Function

Researchers at the Johns Hopkins University School of Medicine have found that a chemical commonly used in the production of such medical plastic devices as intravenous (IV) bags and catheters can impair heart function in rats. Reporting online May 2009 in the American Journal of Physiology, these new findings suggest a possible new reason for some of the common side effects — loss of taste, short term memory loss — of medical procedures that require blood to be circulated through plastic tubing outside the body, such as heart bypass surgery or kidney dialysis. These new findings also have strong implications for the future of medical plastics manufacturing. In addition to loss of taste and memory, coronary bypass patients often complain of swelling and fatigue. These usually resolve within a few months after surgery, but they are troubling, sometimes hinder recovery, but generally go away. His personal experience with coronary bypass surgery propelled his search for a root cause for the loss of taste phenomenon, reports principal investigator Artin Shoukas, PhD, professor of biomedical engineering, physiology and anesthesiology and critical care medicine at Johns Hopkins. “I’m a chocoholic, and after my bypass surgery everything tasted awful, and chocolate tasted like charcoal for months.” Shoukas and Caitlin Thompson-Torgerson, PhD, a postdoctoral fellow in anesthesiology and critical care medicine suspected the trigger for these side effects might be a chemical compound of some kind. To test their theory, Shoukas and his team of researchers took liquid samples from IV bags and bypass machines before they were used on patients. The team analyzed the fluids in another machine that can identify unknown chemicals and found the liquid to contain a chemical compound called cyclohexanone. The researchers thought that the cyclohexanone in the fluid samples might have leached from the plastic. Although the amount of cyclohexanone leaching from these devices varied greatly, all fluid samples contained at least some detectable level of the chemical. The researchers then injected rats with either a salt solution or a salt solution containing cyclohexanone and measured heart function. Rats that got only salt solution pumped approximately 200 microliters of blood per heartbeat and had an average heart rate of 358 beats per minute, while rats injected with cyclohexanone pumped only about 150 microliters of blood per heartbeat with an average heart rate of 287 beats per minute. In addition to pumping less blood more slowly, rats injected with cyclohexanone had weaker heart contractions. The team calculated that cyclohexanone caused a 50 percent reduction in the strength of each heart contraction. They also found that the reflex that helps control and maintain blood pressure is much less sensitive after cyclohexanone exposure. Finally, the team observed increased fluid retention and swelling in the rats after cyclohexanone injections. According to Thompson-Torgerson and Shoukas, they would like to figure out how these side effects — decreased heart function and swelling — occur and to what degree cyclohexanone is involved. Despite the findings in this study, they emphasize that patients should listen carefully to the advice of their physicians. “We would never recommend that patients decline this type of treatment if they need it,” says Shoukas. “On the contrary, such technologies are life-saving medical advances, and their benefits still far outweigh the risks of the associated side effects. As scientists, we are simply trying to understand how the side effects are triggered and what the best method will be to mitigate, and ultimately remedy, these morbidities.” ____________________________

Analysis of Drug-Eluting Stents Data Demonstrates Safety, Efficacy in On-and-Off-Label Use

The Cardiovascular Research Foundation (CRF) announced that results of the largest meta-analysis to date comparing mortality rates for drug-eluting stents (DES) versus bare metal stents (BMS) were published online June 15 in the journal Circulation. The study also compared the rates of myocardial infarction (MI) and target vessel revascularization (TVR). The analysis — which includes approximately 190,000 patients from 56 studies — was performed by a team of researchers led by Ajay J. Kirtane, MD, Assistant Professor of Clinical Medicine at Columbia University College of Physicians and Surgeons; and an interventional cardiologist at NewYork-Presbyterian Hospital/Columbia University Medical Center; and Gregg W. Stone, MD, Immediate Past Chairman of the Cardiovascular Research Foundation; Professor of Medicine at Columbia University College of Physicians and Surgeons; and Director of Cardiovascular Research and Education in the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia University Medical Center. Drs. Kirtane and Stone conducted two parallel meta-analyses examining DES vs. BMS use in both randomized, controlled trials and in observational registry analyses. The overall analysis represents the largest systematic overview of "real-world" (comprising both on-label and off-label) DES use to date and incorporates an overview of both the published literature as well as several unpublished studies presented at major cardiovascular meetings. “The findings from these parallel studies are striking,” said Dr. Stone. The meta-analysis of 22 randomized trials included more than 9,000 patients with recent follow-up from previously published trials. According to the results, “DES resulted in no overall differences in death and MI, with a greater than 50% decrease in subsequent target vessel revascularization procedures,” said Dr. Stone, adding that these findings are consistent with both on-label and off-label use of DES. And in the 34-study observational meta-analysis (involving more than 180,000 "real-world" patients), “DES resulted in significant 22% and 13% reductions in death and MI, respectively, with a similar reduction in TVR (46%) as in the randomized trials, even after adjustment for confounding variables,” said Dr. Stone. “These data are reassuring that DES are safe and effective for a wide-range of patients that are able to take dual antiplatelet therapy for at least one year.” The findings were consistent and robust across a variety of study designs; trials that were included were required to follow patients for at least one year. Dr. Kirtane remarked that these findings should help to reassure patients and physicians about the safety of DES in off-label use. “One of the interesting aspects of this analysis is that it points to significant differences between results obtained from randomized trials and observational analyses. Nonetheless, even with the stated limitations of observational data, the bottom line from both randomized trials and observational analyses is consistent: we can reduce the need for repeat procedures and we do not appear to be harming patients with DES,” he added. ____________________________

Latest IMV Market Report Shows Slowdown in Total Cath Lab Patient Cases from 2006 to 2008

According to IMV’s recent census of cath labs in the U.S., an estimated 3.75 million patient cases were performed at 2,020 cardiac cath lab sites in 2008, including both cardiac and non-cardiac patient cases. Between 2002 and 2006, cath lab patient cases increased ~9% from 3.85 million to 4.21 million, for an average annual growth rate of ~2% per year over the period. However, starting in 2007, the total number of patient cases declined, with a ~10% decline from 4.21 million in 2006 to 3.80 million in 2007, with a slight decrease of 1% to 3.75 million in 2008. “This slowdown in patient cases handled by cath labs is due to the convergence of several factors that have primarily affected both diagnostic and therapeutic coronary cases,” observed Lorna Young, Senior Director, Market Research at IMV. “With the advent of CT coronary angiography procedures (CTA), the volume of diagnostic cath procedures appears to have declined. It is possible that a controversy in the use of drug eluting stents that developed in 2005/06 resulted in a reduction in therapeutic coronary cases. In addition, the increased use of pre-authorization policies by third party insurers may be at play. Taken together with the current economic downturn, the market for cath lab purchases will be slow over the next few years.” “However, the cath labs are not standing still. At the same time that coronary case volume has slowed, we are seeing increased volume of other types of cardiac procedures between 2006 and 2008, such as electrophysiology procedures and cardiac device placements being performed in the cath lab, as well as an increase in non-cardiac cases, such as carotid, iliac, femoral, run-off, renal and extremity studies. And going forward, 25% of the cath lab sites are planning to purchase intravascular ultrasound systems, which is up from five years ago.” IMV’s 2008 Cardiac Cath Lab Market Summary Report describes trends in patient cases, cath lab imaging systems, diagnostic review stations, electrophysiology, intravascular ultrasound, hemodynamic systems, device utilization, contrast media utilization, power injectors for cath contrast, capital and consumables budgets and site operations characteristics. Highlights include: • 38% of the cath lab sites had one room, 35% had two rooms, and 27% had three or more rooms. • At least 89% of the planned cath lab purchases over the next three years will have flat panel image digital detectors. • The proportion of cath labs having dedicated electrophysiology rooms in the department has increased from 23% to 33% over the past decade. • In addition to cardiologists performing non-cardiac cases in the cath labs, endovascular surgeons are the second most likely to be performing non-cardiac cases in cath labs, doing so at 35% of the sites, and interventional radiologists are performing non-cardiac cases in 18% of the cath lab sites. The data source for this report is interviews conducted in 2008 and early 2009 for IMV’s Cardiac Catheterization Lab Census Database, which provides comprehensive profiles of cath labs in the United States. The database can be licensed by qualified subscribers and includes contact and site-specific information. For more information about IMV’s Cath Lab Census Database and Market Summary Report, visit the corporate website at www.imvinfo.com or call 847-297-1404 to speak with a representative. ____________________________

vProtect™ Luminal Shield Stabilizes Vulnerable Plaque

Six-Month Follow-Up Shows Reduced Stenosis, Healthy Endothelial Regrowth in Vessel Treated Proactively for Vulnerable Plaque Six months after placement of a vProtect™ Luminal Shield to treat a “vulnerable” plaque, a follow-up exam revealed reduced plaque burden and reduced stenosis in the target vessel. The exam was part of the SECRITT I trial, a randomized study designed to evaluate the vProtect™ Luminal Shield as a prophylactic treatment for non-flow-limiting vulnerable plaques. The SECRITT I trial is sponsored and conducted by Erasmus University in Rotterdam. The 6-month follow-up exam was performed on May 20 by an interventional cardiology team led by Professor Patrick Serruys, the principal investigator for the SECRITT I study. Evelyn Regar, MD, PhD moderated the case at the EuroPCR congress in Barcelona. The vProtect™ Luminal Shield is manufactured by Prescient Medical, which plans to pursue a vulnerable plaque indication in the future. The patient, a 75-year-old woman, was treated six months earlier for a culprit lesion in the left anterior descending coronary artery. At that time the SECRITT investigators, using a combination of imaging techniques, also located a vulnerable plaque in the patient’s left circumflex artery. The lesion was unremarkable by angiography (37% diameter stenosis); such lesions are usually not treated, even though vulnerable plaques are prone to rupture with potentially fatal consequences. A 3.5 mm vProtect™ Luminal Shield was placed in the vessel (reference vessel diameter 2.74 mm), resulting in a post-procedural stenosis of 30%. The 6-month angiographic follow-up exam was performed per study protocol using a variety of imaging techniques: multi-slice CT, intravascular ultrasound (IVUS), IVUS-virtual histology (IVUS-VH), angiography, and optical coherence tomography (OCT). Additional details on the SECRITT I study methodology can be found in a case study published recently in Nature Reviews Cardiology (vol. 6, May 2009). The follow-up exam indicated that the self-expanding vProtect™ Luminal Shield had stabilized the vulnerable lesion while gently expanding over time. Imaging studies revealed that the residual stenosis in the area of the lesion improved from 30% to just 5% (measured by quantitative angiography). The Shield was covered by a thin layer of healthy tissue with an average thickness of 80 - 110 microns. “These results are comparable to what is seen with drug eluting stents in terms of thickness — we did not see a significant hyperplastic injury response,” commented cardiac pathologist Gary Tearney, MD, PhD. Dr. Tearney, an Associate Professor of Pathology at Harvard University and the Wellman Center for Photomedicine, went on to explain that “The Shield appears to be perfectly designed for just this type of lesion — since it’s self-expanding, there is less chance of rupturing the plaque.” ____________________________

Back Pain News

People with Lower Back Pain are Better Off Exercising More, Not Less

by Bev Betkowski A University of Alberta study of 240 men and women with chronic lower-back pain showed that those who exercised four days a week had a better quality of life, 28 percent less pain and 36 percent less disability, while those who hit the gym only two or three days a week did not show the same level of change. “While it could be assumed that someone with back pain should not be exercising frequently, our findings show that working with weights four days a week provides the greatest amount of pain relief and quality of life,” said Robert Kell, lead author of the study and an assistant professor of exercise physiology at the University of Alberta, Augustana Campus. About 80 percent of North Americans suffer from lower back pain. Kell presented some of the findings May 30, 2009, at the American College of Sports Medicine conference in Seattle, WA In the study, groups of 60 men and women with chronically sore lower backs each exercised with weights in two, three or four-day weekly programs, or not at all. Their progress was measured over 16 weeks. The level of pain decreased by 28 percent in programs that included exercise four days a week, by 18 percent three days a week and by 14 percent two days a week. The quality of life, defined as general physical and mental well-being, rose by 28 percent, 22 percent and 16 percent respectively. ____________________________

Acupuncture Eases Chronic Low-Back Pain in SPINE Trial

Acupuncture can help people with chronic low back pain feel less bothered by their symptoms and function better in their daily activities, according to the largest randomized trial of its kind, published in the May 11 Archives of Internal Medicine. But the SPINE (Stimulating Points to Investigate Needling Efficacy) trial raises questions about how the ancient practice actually works. Compared to the group that got usual care, results were similar for all three of the SPINE trial’s acupuncture groups: individualized, standardized, and simulated (without going through skin). Of the people who got any kind of acupuncture, an extra one in five were functioning significantly better at the end of the seven-week treatment, and an extra one in eight were still functioning better at one year. “This study suggests that acupuncture is about as effective as other treatments for chronic back pain that have been found helpful,” said SPINE trial leader Daniel C. Cherkin, PhD, a senior investigator at Group Health Center for Health Studies (CHS). “But we found that simulated acupuncture, without penetrating the skin, produced as much benefit as needle acupuncture — and that raises questions about how acupuncture works.” The SPINE trial included 638 adult patients at two nonprofit health plans: Group Health Cooperative in Seattle, and Northern California Kaiser Permanente in Oakland. They all rated the “bothersomeness” of their chronic low back pain as at least a 3 on a 0-to-10 scale. None of them had received acupuncture before. They were randomly assigned to one of four groups: • Individualized needle acupuncture, involving a customized prescription for acupuncture points from a diagnostician; • Standardized needle acupuncture, using a single prescription for acupuncture points on the back and backs of the legs, which experts consider generally effective for chronic low back pain; • Simulated acupuncture on those same standardized points, mimicking needle acupuncture but instead of a needle using a toothpick in a needle guide tube without penetrating the skin; • Usual care, which is the standard medical care they would have gotten anyway and that all patients in all groups received. Everyone in the three acupuncture groups (individualized, standardized, or simulated) was treated twice a week for three weeks, and then weekly for four weeks. At eight weeks, half a year, and one year, researchers measured back-related dysfunction and how much symptoms bothered patients. The SPINE team found that at eight weeks, all three acupuncture groups were functioning substantially better, while the group getting only usual care was functioning only slightly better. Dysfunction scores improved significantly more for all three acupuncture groups than for the usual care group. These benefits lasted for a year, although they waned over time. Notably, the outcomes for groups that received the needle and simulated forms of acupuncture did not differ significantly. So although acupuncture effectively treated low back pain, the therapeutic benefit seemed to require neither tailoring acupuncture needle sites to an individual patient nor inserting needles into the skin. “We don’t know precisely why people got back pain relief from the simulated acupuncture,” said Cherkin's co-author Karen J. Sherman, PhD, MPH, a senior investigator at CHS. “Historically, some types of acupuncture have used non-penetrating needles. Such treatments may involve physiological effects that make a clinical difference.” Or it might be all about the mind-body connection, she said: “Maybe the context in which people get treatment has effects that are more important than the mechanically induced effects.” Western medicine does not have highly effective medical treatments for chronic back pain, Cherkin said. Back pain is the primary reason that Americans use complementary and alternative medicine (CAM), including acupuncture. The National Center for Complementary and Alternative Medicine (NCCAM), part of the National Institutes of Health, funded the SPINE trial. “The findings of this research show that acupuncture-like treatments, including simulated acupuncture, can elicit positive responses,” said Josephine P. Briggs, MD, director of NCCAM. “This adds to the growing body of evidence that something meaningful is taking place during acupuncture treatments outside of actual needling. Future research is needed to delve deeper into what is evoking these responses.”
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