Mar-08
According to Frost and Sullivan, “ACIST Medical Systems’ ability to provide innovative, variable-rate contrast injection solutions for cardiovascular angiography applications has endeared the company to its customers. ACIST offers flexible system configurations to meet the specific needs of the customer, lab workflow and patient. For these reasons, Frost and Sullivan recognize ACIST Medical Systems for its ongoing commitment to excellence in medical technology.”
“This award from Frost & Sullivan is quite an honor. It further validates ACIST’s focus on innovation — especially innovation developed with the purpose of making things better and easier for physicians and their patients around the world,” states Fulvio Renoldi Bracco, CEO of ACIST. “We believe this award demonstrates our commitment to continuous innovation. The ACIST CVi system is a fourth-generation product developed as part of a continuing effort to address customer needs. We look forward to ACIST having even more significant innovations in variable-rate contrast delivery coming to market in the near future.”
CircuLite Announces Initiation of European Registration Study For Synergy™ Circulatory Assist Device
CircuLite™, Inc. has advanced its Synergy™ Pocket Circulatory Assist Device clinical program into a 20-patient trial designed to lead to CE Mark approval in the European Union for long-term implantation of Synergy in heart failure patients. This announcement follows successful completion of a first-in-man pilot study of Synergy in four patients. Synergy is a micro implantable blood pump, the size of a AA battery, that can be implanted superficially in a “pacemaker-like” pocket. The device is designed to provide long-term, partial circulatory support in patients with chronic heart failure.
The European registration trial is planned to enroll 20 patients with chronic heart failure and will evaluate the safety and patient quality of life improvements associated with device support of greater than six months. To date, seven patients have been successfully implanted with the Synergy device. Six implants were performed by Bart Meyns, MD, PhD, at Gasthuisberg University Hospital (Katholieke Universiteit) in Leuven, Belgium, the site of the first-in-man trial. One patient in the trial was implanted at Hannover Medical School in Hannover, Germany, by André Simon, MD, Managing Doctor of the Thoracic Transplant Program, and Martin Strüber, MD, Director of the Thoracic Transplant Program. Three patients are currently on device support and are doing well. The Company also announced today that a third trial site, University Hospital in Münster, Germany, has completed training and is now screening patients for the CE Mark trial.
CircuLite recently reported positive results from the European first-in-man pilot study, for which enrollment is now complete. Four patients were implanted with Synergy in this trial. These patients benefited from significant improvements in hemodynamics and were allowed to return to activities of daily living. All patients reached the primary endpoint of successful heart transplantation, with one patient supported for 7 months.
Hospitals That Participate in Clinical Trials May Provide Better Patient
Care Hospitals that participate in clinical trials appear to provide better care for patients with heart attacks or other acute heart events and have lower death rates than hospitals that do not participate in clinical trials, according to a report in the March 24th issue of Archives of Internal Medicine, one of the JAMA/Archives journals.
Quality of care for common conditions such as acute coronary syndromes has slowly improved after the implementation of clinical guidelines, performance measurement and quality improvement efforts. Recent studies suggest that physician leadership, presence of shared goals, administrative support and credible feedback are associated with better hospital performance. Three of these characteristics are also believed to be important in successfully conducting hospital-based clinical trials. “We hypothesized that these same elements required for hospitals to participate in trials could induce beneficial changes in the hospital environment, thereby leading to better processes and outcomes of care for patients treated outside the trial setting,” the authors write.
Sumit R. Majumdar, MD, MPH, of the University of Alberta, Canada, and colleagues analyzed data from 174,062 patients with two specific types of heart conditions, high-risk non–ST-segment elevation acute coronary syndrome with unstable angina and non–ST-segment elevation myocardial infarction. The patients were admitted to 494 hospitals participating in Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the American College of Cardiology/American Heart Association Guidelines (CRUSADE) — an ongoing, voluntary, observational data collection and quality improvement initiative — from Jan. 1, 2001 to June 30, 2006. Process-of-care and in-hospital outcome data were collected. Patients were split into three groups: those treated at hospitals with no trial participation (29,984 patients), low trial participation (93,705 patients) and high trial participation (50,373 patients).
In total, 4,590 patients (2.6 percent) were enrolled in clinical trials, with 145 hospitals having no enrollment, 226 hospitals having a midpoint of 1 percent enrollment and 123 hospitals having a midpoint of 4.9 percent enrollment.
The overall (composite) median (midpoint) guideline adherence scores increased with increasing levels of trial participation, from 76.9 percent among hospitals with no trial enrollment, 78.3 percent for hospitals with low trial enrollment and 81.1 percent among hospitals with high trial enrollment. “In-hospital mortality decreased with increasing trial participation: 5.9 percent vs. 4.4 percent vs. 3.5 percent,” the authors write. “Patients treated at hospitals that participated in trials had significantly lower mortality than patients treated at non-participating hospitals.”
“In conclusion, patients treated at hospitals that participate in clinical trials seem to receive better quality of care and seem to have significantly better outcomes than patients treated at hospitals that do not participate in trials-at least in the setting of acute coronary syndrome,” the authors conclude. “For policy makers and physicians, our findings should assuage some of the concerns related to the possible opportunity costs and potential downsides of participating in the clinical research enterprise.” Source: Arch Intern Med 2008; 168[6]:657-662.
Results from World’s First Clinical Trial of a Fully Bioabsorbable Drug-Eluting Coronary Stent Shows No Thrombosis, Low MACE Rates Out to One Year in Preliminary Clinical Study of Thirty Patients
Data published in the March 13th issue of The Lancet from ABSORB, a clinical trial of a fully bioabsorbable drug-eluting stent (DES) for the treatment of coronary artery disease, demonstrated no stent thrombosis, no clinically driven target lesion revascularizations, and a low (3.3 percent) rate of major adverse cardiac events (MACE) in 30 patients out to one year. These one year results for Abbott’s bioabsorbable everolimus-eluting stent were consistent with performance demonstrated by the system at 6 months, as previously reported in October 2007. Abbott’s prospective, non-randomized, ABSORB clinical trial is designed to evaluate the overall safety and performance of a fully bioabsorbable everolimus-eluting stent out to 5 years.
“Abbott’s bioabsorbable everolimus-eluting stent has demonstrated excellent clinical safety out to one year in patients with coronary artery disease,” said Patrick W. Serruys, MD, PhD, Professor of Interventional Cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, and co-principal investigator in the ABSORB study. “The positive results from this clinical trial form a strong basis for the development of additional bioabsorbable stent platforms with the potential to eliminate some of the restrictions posed by metallic stents in areas such as vessel imaging and vessel remodeling.”
At 6 months, the overall MACE rate in the ABSORB trial was 3.3 percent (one patient, n=30) and late loss, a measure of reduction in vessel lumen diameter after stenting, was 0.44 mm. At one year, the overall MACE rate in the ABSORB trial was consistent with results at 6 months (one patient, 3.3 percent, n=30; 3.4 percent adjusted for one patient who withdrew from follow up, known to be event free at 1 year, n=29). MACE is a composite measure of cardiac death, heart attack and ischemia-driven target lesion revascularization in the ABSORB trial. Abbott's bioabsorbable everolimus-eluting stent also demonstrated 100 percent procedural success and 94 percent device success in the ABSORB trial.
“Patients and physicians like the idea of a stent that does its job and is then absorbed away,” said John A. Ormiston, MB, ChB, cardiologist at Auckland City Hospital, in Auckland, New Zealand and principal investigator in the ABSORB trial.
“Abbott’s bioabsorbable stent has the potential to hold an artery open long enough for healing to occur, and we would expect an artery that is healed to function as it did before it became diseased.” Abbott’s bioabsorbable everolimus-eluting coronary stent is made of polylactic acid, a proven biocompatible material that is commonly used in medical implants such as dissolvable sutures.
About the ABSORB Clinical Trial. The ABSORB trial is a prospective, non-randomized (open label) study designed to enroll up to 60 patients in Belgium, Denmark, France, New Zealand, Poland and The Netherlands. Key endpoints of the study include assessments of safety — MACE and stent thrombosis rates — at 30, 180 and 270 days, with additional annual follow-up for up to five years, as well as an assessment of the acute performance of the bioabsorbable DES. Other key endpoints of the study include successful deployment of the bioabsorbable DES, follow-up measurements assessed by angiography, intravascular ultrasound and state-of-the-art imaging modalities at 180 days and two years.
Vascular Solutions Launches
Pronto® .035” Extraction Catheter Vascular Solutions, Inc. recently launched the Pronto® .035” extraction catheter as the largest addition to its Pronto product line. The Pronto .035” catheter is for the removal of thrombus from large vessels (veins and arteries greater than 4mm). It is in addition to the Pronto V3 catheter, the recently introduced Pronto LP (low-profile) catheter and the specialty Pronto-Short catheter. The Pronto .035” catheter offers over-the-wire delivery and is compatible with standard 0.035” guidewires and 10F sheaths. The 120-degree angled distal 4cm of the Pronto .035” provides enhanced steerability and vessel selection, while its braid-reinforced shaft increases tip control and resists kinking. The Pronto .035” is currently available in the United States.
CABG Best for Multivessel Disease Bypass surgery remains the best option for heart patients with more than one clogged artery, according to the first big study to compare coronary artery bypass graft (CABG) surgery with drug-eluting stents. The new research dims hopes that the less drastic stent procedure would prove to be just as good for people with multiple blockages. In the study, heart attack and death rates were lower among people who had surgery than those given balloon angioplasty and stents. A second study gave stent makers some good news, finding that using these devices “off label,” in non-approved situations, is not as dangerous as many had feared. Both studies were published in The New England Journal of Medicine. Neither is definitive enough to resolve these issues, but they help guide physicians and patients confused about which treatment is best for whom. The CABG study is “a sobering reality check” for people hoping that the newer drug-eluting stents “would level the playing field” and make these treatments equally effective, Harvard University cardiologist Dr. Joseph Carrozza wrote in an accompanying editorial. CABG has become less common as angioplasty has risen dramatically. In 2005, about 469,000 bypasses were performed on 261,000 patients. More than 1.2 million angioplasties were done, though many people had more than one procedure. In 2005, Edward Hannan of the State University of New York at Albany published a study that found CABG to be better than angioplasty with bare metal stents for patients with multiple blockages. His new study makes a similar comparison, but with the newer drug-eluting stents, which came out in 2003. Researchers analyzed two state databases of 17,400 New York residents treated for multiple blockages in 2003 and 2004, and compared deaths and complications 18 months later. Survival rates for both treatments were excellent, but CABG still showed a significant advantage after researchers took into account differences in how sick or old the patients were. People with three clogged arteries had a survival rate of 94 percent after bypass compared with about 93 percent after stenting, which translated to a 20 percent lower risk of death. Those with two blockages had a survival rate of 96 percent after the operation compared with roughly 95 percent after stenting — about a 30 percent lower risk of death. The CABG group also needed fewer repeat procedures and suffered fewer heart attacks after treatment. The New York State Department of Health helped pay for the study. The research covered the period in 2004 when former President Bill Clinton had quadruple bypass surgery, but it isn't known if his case was included, or if angioplasty was an option. Stents still might be better for older patients and others who face greater risks from surgery, or for people who strongly prefer a less drastic treatment, Carrozza wrote. Some types of blockages also cannot be treated with stents. In the second study, a team of U.S. and Canadian scientists looked at 6,551 patients who received either drug-eluting stents or plain metal ones. Among those who received stents off-label, no difference in heart attacks or deaths was seen, though the bare-metal stent group needed more repeat procedures. The findings “appear to validate off-label use” of drug-eluting stents, but this single observational study is not enough to declare that safe, Carrozza wrote. To read the studies online (abstracts are free to view), visit www.nejm.com.
BWH Names Director of Integrated Interventional Cardiovascular Program
New Director Comes from Cleveland Clinic
Deepak L. Bhatt, MD, has been named the new director of the Integrated Interventional Cardiovascular Program at Brigham and Women’s Hospital (BWH) and the VA Boston Healthcare System (VA) effective July 1, 2008. In addition, Dr. Bhatt will also serve as the Chief of the Cardiology Section at the VA Boston Healthcare System and as Senior Investigator at the Thrombolysis in Myocardial Infarction (TIMI) Study Group, directed by Dr. Eugene Braunwald.
“As Director of the Integrated Cardiovascular Intervention Program at BWH and the VA, I am excited to be working with a very talented group of interventional cardiologists who are highly skilled at both patient care and research, and very happy that my arrival will coincide with the opening of the Carl J. and Ruth Shapiro Cardiovascular Center at BWH in May 2008,” said Bhatt.
Dr. Bhatt comes from the Cleveland Clinic, where he has worked on staff in the Department of Cardiovascular Medicine since 2001 and more recently as associate director of the Cleveland Clinic Cardiovascular Coordinating Center since 2006.
“I had a wonderful time at the Cleveland Clinic, a fantastic place from which I would have been happy to retire; however, the chance to work with this very talented group of academic interventionalists at Brigham and Women’s and the VA and the honor of being the Chief of Cardiology of the VA Boston Healthcare System is too great an opportunity to pass up,” said Bhatt.
Dr. Bhatt’s research interests include preventive cardiology, as well as the optimal management of patients with heart attacks. He also has research interests in advanced techniques in cardiac, cerebral, and peripheral intervention. He has authored or co-authored more than 200 articles in peer-reviewed journals. He has been listed in Best Doctors in America for the past several years.
“Dr. Bhatt is an outstanding interventional cardiologist and dedicated researcher. We are very pleased to have him join the cardiovascular team at BWH. His leadership and talent will complement the existing strengths of our Cardiovascular Division,” said Peter Libby, MD, chief of Cardiovascular Medicine at BWH.
Comparison of Anticoagulants for Angioplasty Show Similar Outcomes; Drug-Eluting Stent Appears Advantageous Over Uncoated Stent
In a comparison of anticoagulants and stents for use with angioplasty following a heart attack, the anticoagulants abciximab and tirofiban had similar outcomes for some cardiac measures within 90 minutes after the procedure, while patients who received stents that released the drug sirolimus had a lower risk of major adverse cardiac events within 8 months than patients who received uncoated stents, according to a JAMA study released March 30 to coincide with its presentation at the annual conference of the American College of Cardiology. The study was published in the April 16 issue of JAMA.
Infusion with abciximab and implantation of an uncoated-stent is a treatment strategy used to reduce major adverse cardiac events (MACE) in patients undergoing percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI). It is uncertain whether there may be similar benefits in replacing abciximab with tirofiban, which could have clinical and economical implications. Marco Valgimigli, MD, PhD, of the Cardiovascular Institute, University of Ferrara, Italy, and colleagues evaluated the effect of high-dose tirofiban and sirolimus-releasing stents compared with abciximab infusion and uncoated-stent implantation in 745 patients with STEMI undergoing PCI. The trial was conducted in Italy, Spain, and Argentina between October 2004 and April 2007.
The researchers found that among the 722 patients (97 percent) who had an interpretable electrocardiogram, at least 50 percent resolution of ST-segment elevation on the electrocardiogram at 90 minutes following PCI occurred in 302 of 361 patients (83.6 percent) and 308 of 361 patients (85.3 percent) in the abciximab and tirofiban groups, respectively. Ischemic and hemorrhagic outcomes were similar in these groups.
At 8 months, the MACE rate was similar among those who received tirofiban (9.9 percent) and those who received abciximab (12.4 percent) but was higher among those who were treated with the uncoated stent (54 patients, 14.5 percent) compared with those who were treated with the sirolimus-releasing stent (29 patients, 7.8 percent). Revascularization (repeat procedure to unblock a blood vessel) was reduced from 10.2 percent with the uncoated stent to 3.2 percent with the sirolimus-releasing stent.
“In summary, our study provides evidence that in a broad population of largely unselected patients undergoing PCI for STEMI, tirofiban therapy is associated with a noninferior resolution from ST-segment elevation at 90 minutes postintervention compared with abciximab, and at 8-month follow-up, MACE are approximately halved by sirolimus-eluting stent implantation compared with uncoated stents,” the authors write. Source: JAMA 2008;299[15]
Use of PressureWire® Yields a More Accurate Assessment of Translesion Pressure Gradients in Peripheral Vasculature, Two New Studies Report
Use of a low profile PressureWire yields a more accurate assessment of translesion pressure gradients when compared to catheter-derived pressure gradient (CPG) measurements, according to a recent study.1
Researchers report that although CPG measurements derived from both a catheter and PressureWire correlated with anatomic stenosis, PressureWire gradient was more accurate in estimating the clinical significance of peripheral arterial lesions, thus reducing the risk of inappropriate intervention. The paper was based on a study of 20 lesions in 16 patients undergoing angiography for peripheral vascular disease.
The study, conducted at the Beth Israel Deaconess Medical Center in Boston, is the first to assess this hypothesis in patients with peripheral arterial occlusive disease. “We’ve long suspected that using a 4 or 5 French catheter for measuring pressure gradients would create artifact, simply due to its size relative to the lumen of the vessel,” stated Lawrence Garcia, MD, principal investigator. “This study provides confirmation. In 100 percent of the lesions, the PressureWire provided a better physiologic assessment of the pressure gradient, without the interference of the obstruction due to the catheter.”
Using this low profile PressureWire for arterial pressure measurement yields a more accurate assessment of renal artery stenosis (RAS) and translesion pressure gradients (TPG), than other methods, according to a similar study of 56 RAS patients.2 It reported that diagnoses based on renal angiography and color duplex ultrasound overestimated the severity of RAS by 38 percent and 55 percent compared with those based on a ratio of distal renal pressure to aortic pressure. The study also concluded that this overestimate was likely the cause of disappointing results of renal angioplasty for renovascular hypertension.
References
1. Garcia LA, Carrozza JP Jr. Physiologic Evaluation of Translesion Pressure Gradients in Peripheral Arteries: Comparison of PressureWire and Catheter-Derived Measurements. J Interv Cardiol 2007 Feb; 20(1):63-65.
2. Drieghe B, Madaric J, Sarno G. Assessment of renal artery stenosis: side-by-side comparison of angiography and duplex ultrasound with pressure gradient measurements. Eur Heart J 2008 Feb;29(4):517-524.
Diabetes Medication May Help Slow Progression of Plaque Build-up in Coronary Arteries
A comparison of two types of medications to treat type 2 diabetes finds that pioglitazone is more effective at lowering the rate of progression of plaque build-up in the coronary arteries than glimepiride, according to a study in the April 2 issue of JAMA. There is little evidence to support a preference of one class of glucose-lowering medication over any other as a means to reduce the severity of atherosclerotic disease. Sulfonylureas, such as glimepiride, have been available for decades and represent one of the most commonly-used classes of antidiabetic therapy. Thiazolidinediones (TZDs; such as pioglitazone) are a relatively new class of antidiabetic agents.
Steven E. Nissen, MD, of the Cleveland Clinic, and colleagues conducted the PERISCOPE trial to directly compare the effectiveness of two alternative approaches for treating hyperglycemia, an insulin-providing strategy (glimepiride) vs. an insulin-sensitizing strategy (pioglitazone), in reducing progression of atherosclerosis in 543 patients with type 2 diabetes and coronary disease. The randomized, multicenter trial included 97 academic and community hospitals in North and South America (enrollment August 2003 - March 2006).
The patients underwent coronary intravascular ultrasonography to measure progression of atherosclerosis and were randomized to receive glimepiride or pioglitazone for 18 months. Atherosclerosis progression was measured by the change in percent atheroma volume (PAV; a measurement of plaque build-up in an artery) with repeat intravascular ultrasonography examination in 360 patients at study completion.
The primary efficacy measure, change in PAV, increased 0.73 percent in the glimepiride group and decreased 0.16 percent in the pioglitazone group. An alternative analysis imputing values for patients who did not have follow-up ultrasound procedures and based on baseline characteristics showed an increase in PAV of 0.64 percent for glimepiride and a decrease of 0.06 percent for pioglitazone. A secondary efficacy measure, change in maximum atheroma thickness increased in the glimepiride group and decreased in the pioglitazone group.
“Patients randomized to pioglitazone exhibited a lower rate of progression of coronary atherosclerosis across a wide array of prespecified and exploratory subgroups. These finding may have important implications for defining the optimal strategy for management of patients with type 2 diabetes and coronary atherosclerosis,” the researchers conclude.
Source: JAMA 2008;299 [13]: 1561-1573.
