Clinical and Industry News

Maquet Cardiovascular Announces Dedication of Its New United States Headquarters in Wayne, NJ

Relocation of manufacturing of cardiovascular medical devices from Puerto Rico to New Jersey creates 350 new jobs Maquet Cardiovascular LLC, a global provider of cardiovascular technologies, celebrated and formally opened its new United States headquarters in Wayne, New Jersey. The dedication ceremony was attended by local and state dignitaries, the Maquet leadership team, and local employees from the company’s cardiovascular, critical care and surgical workplace divisions. Maquet Cardiovascular’s history has its roots in the historic Paterson textile manufacturing industry that flourished in New Jersey in the 19th and 20th centuries. While much of this industry has disappeared in the state, Maquet Cardiovascular employs many descendants of the past textile industry who apply this same skilled trade and craftsmanship to the production of its knitted and woven vascular grafts, used across the U.S. in life-saving procedures every day. Maquet Cardiovascular’s history in New Jersey started with Meadox Medical, which was founded in Haledon in 1954. Meadox was acquired by Boston Scientific Corporation in 1995. In 2008, Maquet acquired the Meadox business and the former Guidant cardiovascular surgery business from Boston Scientific, and formed Maquet Cardiovascular. In 2009, the company acquired Datascope, another New Jersey-based medical device company. With the unemployment rate in New Jersey at 9.5 percent, Maquet Cardiovascular’s continued expansion and ramp-up of its wholly-owned manufacturing facility will hire up to 350 new employees while maintaining jobs for 1,100 statewide residents as it seeks to ramp up its wholly-owned manufacturing activities that were previously conducted primarily in Puerto Rico. The company hopes to expand its New Jersey work force in the future, but, like many medical device companies, is concerned about potential new taxes that would inhibit growth in the medical technology sector. The company has already invested nearly $40 million to develop its new headquarters and manufacturing areas. The 282,000 square foot site will include state-of-the-art manufacturing and house a Surgical Academy and Showroom, complete with full-scale operating room environments for training and education. Construction is also slated to start soon on an auditorium that will seat 180 people with state-of-the-art multimedia capabilities, including interpreting and production booths. _____________________

Indianapolis-based Clarian Cardiovascular to Offer a Transradial Center of Excellence

Clarian Cardiovascular (Indianapolis, IN) has established a Transradial Center of Excellence in an effort to offer patients transradial cardiac catheterization, a procedure that significantly reduces recovery time and improves patient outcomes. While this technique isn’t new, less than 2 percent of cardiac catheterizations in the United States use the transradial approach because only a small percentage of interventional cardiologists are trained in this specialized procedure. In fact, transradial access leads the way in many parts of the world, including Europe, Japan, China and Canada. The transradial catheterization is safer, offers no scarring, a decreased risk of bleeding, lowered risk of all complications, less risk of trauma to adjacent nerves and blood vessels, reduced hospital and health care costs, and a shorter recovery period. The recovery time for the transradial approach is less than 2 hours of bedrest with discharge within four hours, depending on the procedure. Transradial cardiac catheterizations benefit all patients, but especially those with lower back pain, arthritis, obesity and peripheral vascular disease. Clarian Cardiovascular’s Transradial Center of Excellence is under the direction of George Revtyak, MD, FACC, FSCAI, FAHA. “The femoral approach remains the dominant technique because it is easy to learn. However, this common approach leads to substantial patient discomfort due to prolonged groin compression resulting in immobilization,” said Dr. Revtyak. “That’s why it was important for Clarian Cardiovascular to establish the Transradial Center of Excellence, so people in the state of Indiana and beyond have access to another cardiac catheterization option that is truly beneficial in more ways than one.” The Clarian Transradial Center of Excellence will also offer a physician training center with state-of-the-art equipment at Methodist Hospital where cardiologists will receive hands-on training covering the clinical and practical aspects of transradial access, including the use of simulators to focus on the use of different catheters and their tactile feel. The 3-D component of the simulator allows physicians to truly understand how catheters respond to torque and steering. Currently, the only transradial training centers available outside of the medical schools are in the states of California, New York and Florida. The transradial catheterization technique was pioneered by a Dr. Lucien Campeau, a French-Canadian physician, in 1989, and in August 1992, the first patients were treated with this procedure at the Amsterdam Department of Interventional Cardiology of the Onze Lieve Vrouwe Casthuis in Amsterdam. About Clarian Health. Clarian Health is an Indiana-based, private, non-profit organization offering a broad base of tertiary services, specialized pediatric care and a Level 1 Trauma Center. Clarian is Indiana's most comprehensive health center and one of the busiest hospital systems in the nation. ____________________

Diagnosis of Cardiovascular Disease Associated With Risk of Subsequent Hip Fracture

A study that includes twins finds that the risk of hip fracture was significantly increased following a diagnosis of cardiovascular disease (CVD), with analysis also suggesting a genetic predisposition to the development of CVD and fractures, according to a study in the October 21 issue of JAMA. CVD and osteoporosis, common in elderly individuals, have been regarded as independent age-related disorders. Research has suggested that there may be common mechanisms that cause these diseases. Stroke is a well-documented risk factor for hip fracture, but it is uncertain whether other CVDs may increase the risk of future hip fracture. “It is also unknown whether the risk for hip fracture differs depending on CVD diagnosis and sex, as well as whether the risk reflects lifestyle and individual environmental influences or genetic constitution,” the authors write. Ulf Sennerby, MD, of Uppsala University, Uppsala, Sweden, and colleagues used information from 31,936 twins in the Swedish Twin Registry to investigate the association between cardiovascular events and future hip fracture risk, and to examine to what extent the relation was attributable to genes or associated with other lifestyle factors. The researchers note that a study that includes twins provides a framework for an ordinary group analysis while simultaneously examining whether the relation between cardiovascular events and hip fracture is explained by genetic and early environmental factors. The twins, born from 1914-1944, were followed up from the age of 50 years. The National Patient Registry identified twins with CVD and fractures from 1964 through 2005. The researchers found that the crude absolute rate of hip fractures was highest after a diagnosis of heart failure or stroke, compared to after a diagnosis of peripheral atherosclerosis or ischemic heart disease and lowest for those without a CVD diagnosis. In comparison with individuals without CVD, patients with heart failure had about a 4-fold increased rate of hip fracture and individuals with a stroke had 5 times the risk. The elevated hip fracture rate was also present after ischemic stroke, hemorrhagic stroke, peripheral atherosclerosis and ischemic heart disease. “Identical twins without heart failure and stroke also had, after their co-twins had been exposed to these respective diseases, an increased rate of hip fracture,” the authors write. These sibling twins who were considered to be “pseudoexposed” (i.e., the twin without CVD was considered to be “pseudoexposed” to having CVD based of their co-twin having a CVD event) for heart failure had a 3.7-fold increased risk for hip fracture; pseudoexposure for stroke had a 2.3 times higher risk of hip fracture. “An increased hip fracture risk for the pseudoexposure in the co-twin analyses, particularly in identical twins, is an indication that genes predispose to the development of CVD and fractures. Most of the overall increased rate of hip fracture after heart failure (and part of the increased risk after stroke) appears to be explained by genes or by early environmental sharing (i.e., not individual lifestyle habits or other individual-specific environmental factors),” the researchers write. “Clinicians should be aware of the considerably increased rate of hip fracture in both sexes, especially after a recent hospitalization for CVD. Genetic predisposition is probably a major determinant of the excess fracture rate,” the authors conclude. Source: JAMA 2009;302[15]:1666-1673. ____________________

New Strategy for Mending Broken Hearts: Engineers at Duke Create 3-D “Patch” of Cardiomyocytes

By mimicking the way embryonic stem cells develop into heart muscle in a lab, Duke University bioengineers believe they have taken an important first step toward growing a living “heart patch” to repair heart tissue damaged by disease. In a series of experiments using mouse embryonic stem cells, the bioengineers used a novel mold of their own design to fashion a three-dimensional “patch” made up of cardiomyocytes. The new tissue exhibited the two most important attributes of heart muscle cells — the ability to contract and to conduct electrical impulses. The mold looks much like a piece of Chex cereal, in which researchers varied the shape and length of the pores to control the direction and orientation of the growing cells. The researchers grew the cells in an environment much like that found in natural tissues. They encapsulated the cells within a gel composed of the blood-clotting protein fibrin, which provided mechanical support to the cells, allowing them to form a three-dimensional structure. They also found that the cardiomyocytes flourished only in the presence of a class of “helper” cells known as cardiac fibroblasts, which comprise as much as 60 percent of all cells present in a human heart. “If you tried to grow cardiomyocytes alone, they develop into an unorganized ball of cells,” said Brian Liau, graduate student in biomedical engineering at Duke’s Pratt School of Engineering. Liau, who works in the laboratory of assistant professor Nenad Bursac, presented the results of his latest experiments during the annual scientific sessions of the Biomedical Engineering Society in Pittsburgh. “We found that adding cardiac fibroblasts to the growing cardiomyocytes created a nourishing environment that stimulated the cells to grow as if they were in a developing heart,” Liau said. “When we tested the patch, we found that because the cells aligned themselves in the same direction, they were able to contract like native cells. They were also able to carry the electrical signals that make cardiomyocytes function in a coordinated fashion.” “The addition of fibroblasts in our experiments provided signals that we believe are present in a developing embryo,” Liau said. The need for helper cells is not uncommon in mammalian development. For example, he explained, nerve cells need “sheathe” cells known as glia in order to develop and function properly. Bursac believes that the latest experiments represent a proof-of-principle advance, but said there are still many hurdles to overcome before such patches could be implanted into humans with heart disease. “While we were able to grow heart muscle cells that were able to contract with strength and carry electric impulses quickly, there are many other factors that need to be considered,” Bursac said. “The use of fibrin as a structural material allowed us to grow thicker, three-dimensional patches, which would be essential for the delivery of therapeutic doses of cells. One of the major challenges then would be establishing a blood vessel supply to sustain the patch.” The researchers plan to test their model using non-embryonic stem cells. For use in humans, this is important for many reasons, both scientifically and ethically, Bursac said. Recent studies have demonstrated that some cells from human adults have the ability to be reprogrammed to become similar to embryonic stem cells. “Human cardiomyocytes tend to grow a lot slower than those of mice,” Bursac said. “Since it takes nine months for the human heart to complete development, we need to find a way to get the cells to grow faster while maintaining the same essential properties of native cells.” If they could use a patient’s own cells, the patch would also evade an immune system reaction, Bursac added. The research was supported by National Institutes of Health, the National Heart Lung Blood Institute and Duke’s Stem Cell Innovation program. ____________________

Philips Launches Upgrade Program for Allura Xper

Philips has launched a new upgrade program for its Allura Xper family of cardio/vascular x-ray devices. The complimentary upgrade will be provided globally to more than 2,000 customers with Customer Service Agreements. All other Philips Cardiovascular customers will be able to purchase this upgrade. The upgrade includes sophisticated remote technologies for Remote Proactive Support, enabling Philips to automatically monitor each system and send alerts when issues arise. This helps to identify and resolve potential issues quickly — in some cases before the clinician is even aware of the problem. For users in North America, the solution goes one step further. With Remote Desktop, customer service teams are able to take control of systems and guide customers through the required steps for enhanced application support over the phone. In addition, the upgrade puts systems on the latest technology platform, giving clinicians the opportunity to add a suite of new applications that will help to further enhance clinical workflow. With the number of patients requiring interventional procedures continuing to grow, there is increasing pressure on interventional clinicians to work more efficiently. Ensuring maximum uptime of cardio/vascular x-ray systems is key to maintaining a smooth clinical workflow. Following the upgrade, the Allura Xper system will be ready for the latest advanced tools to further enhance patient care, including: • XperGuide: CT-like soft tissue imaging providing live 3D needle image guidance during percutaneous needle interventions in the angio lab. • XperSwing: an automated dual-axis rotational angiography option allowing acquisition of all desired anatomical projections in a single run, which can help to reduce dose and contrast medium. • FlexVisionXL: a new viewing concept with a 56-inch (125-cm) LCD screen that enables clinicians to display multiple, sharp images simultaneously in their own preferred size and layout. _____________________

South Dakota: Sanford Breaks Ground on New Heart Hospital

On October 7th, Sanford Health (Sioux Falls, SD) celebrated the groundbreaking of the new Sanford Heart Hospital. The event, held on the site of the new heart hospital at the corner of 18th Street and Grange Avenue, included community participants, physicians and staff from Sanford Heart Hospital. When it opens in 2011, the 205,000-square-foot Sanford Heart Hospital will include 58 inpatient beds, cardiovascular operating rooms, cath labs, and clinic and outpatient services. “We have had a tremendous heart program for three decades and this new facility will help us continue to deliver patient care in one convenient location for our patients while keeping our other services right at their fingertips,” said Charles P. O’Brien, MD, President, Sanford USD Medical Center. The new Sanford Heart Hospital will provide convenience to patients and their families by having physician offices, outpatient testing, surgical services, cath labs and consultation services all in one building. Patients and their families will be greeted by valet parking and centralized registration no matter if they are visiting for a physician appointment, testing or an inpatient stay. The goal of this new building is to make heart care easily accessible in one location. “Our patients are our priority,” said Tom Stys, MD, Sanford Cardiology Medical Director. “We have a strong history of outstanding care at Sanford. The goal of this new building is to make that quality heart care easily accessible in one location. This new facility will contain cutting-edge technology in our cath labs and surgical suites. The patient rooms not only contain the latest in technology, but are designed with patient and family comfort in mind.” The new Sanford Heart Hospital building will also include Sanford Clinic Heart Partners and Sanford Clinic Cardiac, Thoracic and Vascular Surgery. ___________________

Less Invasive Procedure for Repair of Abdominal Aortic Aneurysm May Reduce Short-Term Risk of Death

Patients who received the less-invasive endovascular repair of an abdominal aortic aneurysm had a lower risk of death in the first 30 days after the procedure compared to patients who an open repair, but both procedures had similar rates of death after two years, according to a study in the October 14 issue of JAMA, a theme issue on surgical care. Frank A. Lederle, MD, of the Veterans Affairs Medical Center, Minneapolis, presented the findings of the study at a JAMA media briefing in Chicago. “Each year in the United States, 45,000 patients with unruptured abdominal aortic aneurysm (AAA) undergo elective repair, resulting in more than 1,400 perioperative [the first 30 days after surgery or inpatient status] deaths,” according to background information in the article. Endovascular repair was developed to provide a less invasive method than the standard open procedure, which involves an abdominal incision. But “limited data are available to assess whether endovascular repair of AAA improves short-term outcomes compared with traditional open repair,” the authors write. Dr. Lederle and colleagues are conducting a multicenter clinical trial to examine outcomes after elective endovascular and open repair of AAA. This is an ongoing 9-year trial, with this interim report including postoperative outcomes of up to 2 years for 881 patients (age 49 years or older). Patients were randomized to either endovascular (n = 444) or open (n = 437) repair of AAA. Average follow-up was 1.8 years. The researchers found that the rate of death after surgery was significantly higher for open repair at 30 days (0.2 percent vs. 2.3 percent), and at 30 days or during hospitalization (0.5 percent vs. 3.0 percent). But there was no significant difference in all-cause death at two years (7.0 percent vs. 9.8 percent), and death after the perioperative period was similar in the two groups (6.1 percent vs. 6.6 percent). Patients in the endovascular repair group had reduced procedure time, blood loss and duration of mechanical ventilation. “Hospital and ICU stays were shorter with endovascular repair and need for transfusion was decreased. No significant differences were observed in major morbidities, secondary procedures, or aneurysm-related hospitalizations,” the authors write. “Longer-term data are needed to fully assess the relative merits of the 2 procedures.” Source: JAMA 2009;302[14]:1535-1542. ____________________

First Patients Enrolled into DAPT Study To Advance Understanding of Dual AntiPlatelet Therapy Following Drug-Eluting Stent Procedures

The Harvard Clinical Research Institute (HCRI) announced that the first patients have been enrolled in the DAPT Study, marking the official initiation of the four-year clinical trial to investigate the duration of dual antiplatelet therapy (DAPT, the combination of aspirin and a thienopyridine/antiplatelet medication) following drug-eluting stent implantations. The large-scale public health study is expected to bring clarity to the global medical community regarding the benefits of 12 versus 30 months of dual antiplatelet therapy in patients receiving drug-eluting stents to address coronary artery lesions. The first patients were enrolled into the DAPT Study by co-principal investigator, Dean J. Kereiakes, MD, medical director of The Christ Hospital Heart and Vascular Center and The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital, Cincinnati, Ohio. The DAPT Study will be conducted through a public-private collaboration involving HCRI, four major stent manufacturers: Abbott (Xience V), Boston Scientific Corporation (Taxus, Promus), Cordis Corporation (Cypher), Medtronic, Inc. (Endeavor); the manufacturers of thienopyridine/antiplatelet medications: Bristol-Myers Squibb Company/Sanofi Pharmaceuticals Partnership [Plavix (clopidogrel bisulfate)] and Eli Lilly and Company and Daiichi-Sankyo Company Limited [Effient (prasugrel)]; and the U.S. Food and Drug Administration (FDA). HCRI, which is responsible for the scientific management of the DAPT Study and the independent analysis of the resulting data, received funding support from each of the drug and device manufacturers. “This study is the first postmarket investigation in which the FDA brought together industry competitors who put aside competition and achieved an unprecedented level of cooperation with regulators and academia to answer a major public health question,” said FDA Commissioner Margaret A. Hamburg, MD. Principal investigator, Laura Mauri, MD, a cardiologist at the Brigham and Women’s Hospital in Boston, MA and chief scientific officer of Harvard Clinical Research Institute said, “Current guidelines call for patients who are treated with drug-eluting stents to remain on blood-thinning medications for at least one year, but some physicians continue prescribing medications considerably longer in hopes of preventing very late stent thrombosis. The DAPT Study will enroll a broad spectrum of patients treated with stents and will look at both stent-related and patient-related outcomes to help define an appropriate course of therapy following placement of a drug-eluting stent.” “Because patients will be followed for almost three years for both stent-related and clinical outcomes, the DAPT Study results will be instrumental in establishing the standard of care following a drug-eluting stent procedure,” said Dr. Kereiakes. DAPT Study Protocol. The DAPT (dual antiplatelet therapy) Study will assess the benefit of 12 versus 30 months of dual antiplatelet therapy for preventing stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE) in subjects undergoing percutaneous coronary intervention (PCI) with drug-eluting stent placement for the treatment of coronary artery lesions. The trial will be a four-year, prospective, randomized, double-blind trial that is expected to enroll over 15,000 subjects being treated with a drug-eluting stent (DES) at over 200 international centers. A cohort of approximately 5,000 subjects treated with a bare-metal stent (BMS) will also be enrolled. All subjects will receive 12 months of open-label thienopyridine/antiplatelet treatment in addition to aspirin. After 12 months, subjects who are free from all MACCE or major bleeding events will be randomized 1:1 to either placebo or ongoing dual antiplatelet therapy for an additional 18 months followed by three months of observational follow-up. Both arms will continue aspirin therapy. The choice of stent type and thienopyridine drug will be at the discretion of the patient and physician. The co-primary endpoints for this trial are the incidence of the composite of all death, myocardial infarction (MI) and stroke (referred to as major adverse cerebral and cardiovascular events, or MACCE) between 12 and 33 months post-drug-eluting stent procedure and the incidence of stent thrombosis (ST) between 12 and 33 months post-stent procedure. The primary safety endpoint for this trial is incidence of major bleeding between 12 and 33 months post-drug-eluting stent procedure. The study will also include an adjusted comparison of patients treated with BMS compared with DES on varying durations of antiplatelet therapy. Due to the large sample size necessary for this study to detect small but clinically important differences, the FDA has allowed a limited amount of data to be contributed to the final DAPT Study analysis from several drug-eluting stent manufacturer-sponsored studies. The manufacturer-run studies have been designed to reproduce the DAPT Study randomization to 12 versus 30 months of therapy, and follow the same data collection, adjudication, and analytic processes as the DAPT Study. Several manufacturer-run studies have begun enrollment. The final analysis, performed by the Harvard Clinical Research Institute, will contain data from each of these sources to achieve overall enrollment of over 20,000 subjects. More information about the DAPT Study is available at www.DAPTStudy.org, and the DAPT Study protocol and patient eligibility information are available on www.clinicaltrials.gov.

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