Mercy Unveils State-of-the-Art Cath Lab in ER

Mercy again leads nation in acute heart care with complete cardiac catheterization lab in its emergency department

Mercy Medical Center in Canton, Ohio, has established a state-of-the-art cardiac catheterization lab within its emergency department (ED). The dedicated ED cath lab dramatically reduces the transition period from the ED to the cardiac catheterization lab to mere seconds.

The protocols in the Mercy Emergency Chest Pain Center streamline efforts to speed the treatment of heart attack patients, says Dr. Ahmed A. El Ghamry Sabe, MD, Medical Director of the Mercy Heart Center. Saving lives is a team effort. Everyone plays a role the fast response of the paramedics; the immediate evaluation by our Emergency Chest Pain Center nursing staff and physicians; and the immediate response from the cath lab team of experienced nurses, technologists and interventional cardiologists. This is what makes the picture complete.

How the ED cath lab saves time:
The EMS crew relays vital information to Emergency Chest Pain Center en route to Mercy Medical Center;
The Emergency Chest Pain Center Team makes a diagnosis and prepares for the patient™s arrival;
The patient is admitted directly into the ED cath lab, located a few steps inside a dedicated outside entrance, and the procedure begins;
The dramatic reduction in door-to-balloon time results in increased survival rates, faster recoveries and a higher quality of life for patients.
According to the American Heart Association™s 2006 statistical update, coronary heart disease (CHD) is the single biggest killer of men and women in the United States. This year an estimated 1,200,000 Americans will have a new or recurrent coronary attack. About 40% of the people who experience a coronary attack will die from it.

Mercy has helped pioneer some of the nation™s most innovative heart procedures. In addition to performing the world™s first angioplasty in an emergency department and instituting the nation™s first accredited Emergency Chest Pain Center (ECPC), Mercy was the first hospital in Northeast Ohio to perform Minimally Invasive Direct Coronary Artery Bypass Surgery.

Mercy Medical Center, along with the Sisters of Charity of St. Augustine Health System and University Hospitals Health System, operates a 476-bed hospital. It has 550 physicians on its medical staff and employs 2,500 people. A Catholic hospital, Mercy Medical Center upholds the mission and philosophy of the Sisters of Charity of St. Augustine and continues to be responsive to the needs of the community, including the provision of care to all, regardless of their ability to pay. For more information, see www.cantonmercy.com

High Levels of Two Chemicals in the Bloodstream Indicate Need for Aggressive Action to Help Patients with Clogged Arteries Avoid MI, Death, New Study Shows
Researchers working to decode chemical SOS signals sent out by disease-damaged hearts believe they now know better when to aggressively clear clogged arteries and when medical procedures may be unnecessary and even harmful.

The research, led by Uppsala University in Sweden, appears in the Sept. 19 edition of the Journal of the American College of Cardiology.

According to the research, high levels of two proteins in the bloodstream indicate that patients with acute coronary syndromes are at high risk of having potentially fatal heart attacks. Taking aggressive action to treat their blocked arteries will reduce their risk of dying within one year.

On the other hand, patients with low levels of these proteins, also called biomarkers, are not at high risk for deadly heart attacks and may even be harmed by having angioplasty or bypass surgery to treat blocked arteries.

The proteins “ troponin-T (TnT) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) “ are just two of the biomarkers being studied by physicians and scientists around the world in an effort to improve treatment for a wide range of illnesses.

Biomarkers are analyzed in blood samples taken from patients when they are admitted to the hospital, said Stefan James, MD, PhD, senior consultant cardiologist and catheterization laboratory director for Uppsala University Academic Hospital™s Department of Cardiology. With a better understanding of these markers, we will be able to assess risk for individual patients more accurately.

We will also be able to individualize treatment alternatives, said Dr. James, lead author of the new study. Thereby, we may avoid costly and potentially hazardous treatments for patients at low risk and still provide lifesaving and symptom-relieving medical and surgical treatments for those at high risk.

For the study, researchers conducted a statistical analysis of data collected as part of the Global Utilization of Strategies To open Occluded arteries-IV trial (GUSTO-IV). Records of 2,340 patients who underwent procedures to clear their blocked arteries within the first 30 days of the international trial were included in the analysis. All of these patients were diagnosed with non-ST segment elevation acute coronary syndromes.

Researchers found that if either TnT or NT-proBNP levels were elevated, patients benefited from aggressive treatment to clear their coronary arteries. But if either level was low or non-existent, patients did not benefit. In this group, undergoing invasive medical procedures resulted in a significant increase of death within one year of treatment. All results were independent of other chemical biomarkers in the blood, including C-reactive protein and interleukin-6.
Although TnT levels are routinely checked in patients seeking care for chest pain, NT-proBNP levels are not. Dr. James said this study shows both levels should be tested.

I think NT-proBNP adds important information, he said, and the test should be available for use in both emergency and in outpatient clinics.
Still, Dr. James said, tests and treatments can only do so much to keep people healthy.

We have developed tools for identifying patients at high risk for heart attack, he said. With these markers, we are also able to rule out serious heart disease with high accuracy. Now we want patients to take responsibility for their lifestyle and environment. Personally, I am concerned about the health of the next generation of Americans, particularly. Lack of exercise and junk food may ruin all of our common medical efforts and successes.

Suresh Mulukutla, MD, FACC, an assistant professor of medicine at the University of Pittsburgh, was not connected with the research but said it gives physicians one more tool to help ensure that every patient receives the most appropriate treatment.

This is an important finding because in many centers across the world, if patients present with acute coronary syndromes, they are rushed to the catheterization lab for angioplasty or stenting, said Dr. Mulukutla, an interventional cardiologist. This study suggests that if we use these biomarkers, we may be able to better select patients who would truly benefit from such aggressive procedures. Conversely, we could treat lower-risk patients with more conservative strategies.

Although the study involved a retrospective data analysis, Dr. Mulukutla said, the large numbers of patients involved argue in favor of the reliability of these results.

Dr. James reports no disclosures with this research, a substudy of the GUSTO-IV trial. Funding comes from a variety of sources, including Centocor Inc. and Eli Lilly and Co.

Sudden Cardiac Death Does Not Always Happen Without Warning
Sudden cardiac death is not as sudden or symptom-free as previously believed, German researchers report in Circulation: Journal of the American Heart Association.

A study of 406 sudden cardiac death (SCD) patients indicates that patients often have symptoms, especially the typical symptom angina pectoris, for as long as 120 minutes before an arrest and two-thirds of cardiac arrest patients have a history that predisposes them to sudden cardiac death, said lead author Dirk Müller, MD, PhD.

The data indicate that SCD rarely occurs suddenly out of the blue, which suggests that it is important to give at-risk patients and families detailed information about signs so they can recognize warning symptoms and react accordingly, said Müller, cardiologist and emergency physician at the Medizinische Klinik II, Kardiologie and Pulmologie in Berlin.

In the study, researchers found that 72 percent of cardiac arrests, defined as complete cessation of the heart™s pumping action, occurred at home and 67 percent of the arrests were witnessed by others.

The 406 patients who had cardiac arrests were from 5,831 rescue missions performed by a physician-manned mobile intensive care unit at the University of Berlin during a one-year period.

Of the 406 patients analyzed, 58 percent were men. The men averaged 68 years old; the women, 76.

After the return of spontaneous circulation or resuscitation efforts stopped, Müller and colleagues collected detailed, on-the-scene information about symptoms and their duration from bystanders and the surviving patients.
The researchers collected information about symptoms preceding arrest for 323 patients, including 274 who were direct eye- or ear-witnessed collapses.

One hundred and six patients had a history of coronary heart disease documented by angiography and 16 of them had a previous arrest and resuscitation.

The most common warning symptom was chest pain with a duration range of 20 minutes to 630 minutes. Chest pain was present in one in four (25 percent) patients with witnessed arrests and in 33 percent of patients who had symptoms for less than one hour preceding arrest.

Breathlessness was a symptom in 17 percent of witnessed arrests and in 30 percent of patients who had the symptom for less than an hour before the arrest. Other common symptoms were nausea, vomiting, dizziness or fainting.

Bystanders performed cardiopulmonary resuscitation (CPR) on 57 patients, and 13 of them (23 percent) survived to hospital discharge. Among the 349 patients who did not receive bystander CPR, only 13 patients (4 percent) survived, which the study found highly significant.

Furthermore, bystander CPR attempts occurred much less often among patients resuscitated at home (11 percent) than at public locations (26 percent).

Training and prevention efforts should be focused on how to recognize the emergency, CPR training and automated external defibrillator (AED) use, Müller said. Our study suggests that shifting the focus to educating high-risk patients and families may lead to earlier recognition, a quicker call to the emergency medical system (EMS), a higher percentage of bystander CPR and thus to a higher probability of survival in patients with sudden cardiac death.

Avandia® (rosiglitazone maleate) Reduced Risk of Progression From Pre-Diabetes To Type 2 Diabetes by 62 Percent in Largest Completed Diabetes Prevention Trial

41 Million People in the United States Have Pre-diabetes, a Precursor to the Development of Type 2 Diabetes

In the largest completed diabetes-prevention trial to date, Avandia® (rosiglitazone maleate) reduced the risk of developing type 2 diabetes by 62 percent relative to placebo among individuals at high risk of developing type 2 diabetes. This 62 percent reduction was highly statistically significant (p<0.0001) and additive to standard counseling on healthy eating and exercise, which was provided to all participants in the trial. The results of the landmark study were reported in The Lancet and at the 42nd annual meeting of the European Association for the Study of Diabetes (EASD).

The DREAM (Diabetes REduction Assessment with ramipril and rosiglitazone Medication) trial evaluated the likelihood of progression to type 2 diabetes over a three-year median follow-up period among 5,269 participants with pre-diabetes. DREAM is an international, multi-center, randomized, double-blind, 2x2 factorial trial involving 5,269 participants from 21 countries with impaired glucose tolerance (IGT) and/or impaired fasting glucose (IFG), also known as pre-diabetes, who are therefore a high risk of developing type 2 diabetes. The DREAM study was conducted by Population Health Research Institute at the Michael G. DeGroote School of Medicine at McMaster University and Hamilton Health Sciences in Hamilton Ontario. DREAM was funded by a peer-reviewed grant from the Canadian Institutes of Health Research (CIHR) via the CIHR/Rx&D Collaborative Research Program as well as by GlaxoSmithKline, sanofi-aventis and King Pharmaceuticals.

Participants were randomized to rosiglitazone (8 mg daily) or placebo and to ramipril (15 mg daily) or placebo and were assessed every six months for three to five years to determine if rosiglitazone or ramipril can reduce the risk of developing type 2 diabetes in individuals with pre-diabetes, when added to healthy eating and exercise counseling. The DREAM study was not designed as a direct comparison between rosiglitazone and ramipril. Results from the ramipril arm of the study, which increased regression to normoglycemia but did not reduce the risk of diabetes or death, are also being reported at EASD and published separately in The New England Journal of Medicine.

In this study, designed and conducted by the Population Health Research Institute at McMaster University, Canada, 10.6 percent of participants receiving rosiglitazone progressed to type 2 diabetes versus 25 percent of participants treated with placebo. In the composite primary endpoint of development of diabetes or death from any cause, rosiglitazone demonstrated a 60 percent risk reduction relative to placebo (p<0.0001).

The DREAM findings are particularly significant as we are in the midst of an epidemic of type 2 diabetes with global implications. It is also noteworthy that the damaging complications of type 2 diabetes can often precede the diagnosis of this condition by several years, said Dr. Bernard Zinman, DREAM Steering Committee Member, director of the Diabetes Centre, Mount Sinai Hospital and professor of medicine, University of Toronto, Canada. By demonstrating that rosiglitazone significantly reduced the risk of developing type 2 diabetes, these data provide important evidence that it may be possible to alter the course of rising blood sugar levels and its consequences.

Over the three-year median follow-up period of the trial, 51 percent of the participants receiving rosiglitazone returned to normal blood sugar levels compared to 30 percent of participants receiving placebo. Thus, participants taking rosiglitazone were 70 percent (p<0.0001) more likely than those taking placebo to return to normal blood sugar levels. As might be expected, participants in the placebo group with higher Body Mass Index (BMI), an indicator of obesity, were more likely than those with lower BMI to progress to type 2 diabetes. However, the risk of developing diabetes did not increase with BMI in the group randomized to rosiglitazone. These findings suggest that rosiglitazone may reduce the risk of developing diabetes that is attributable to obesity.

Safety and Efficacy of Drug-Eluting Stents Reaffirmed in Literature
Boston Scientific Corporation welcomed the results of two studies and an editorial published in The New England Journal of Medicine (NEJM), all of which reaffirmed the safety and efficacy of drug-eluting stents.

Commenting on the editorial and articles describing results of two randomized clinical trials, PASSION and TYPHOON, the company stated:
We welcome the conclusion of The New England Journal of Medicine that drug-eluting stents are a safe and effective therapy, with lower retreatment rates than bare-metal stents. Patients who have suffered acute myocardial infarction (AMI) are among the most complex and difficult groups to treat*. In The PASSION trial, the lower rates of cardiac death and recurrent heart attack for the Taxus stent as compared to the bare-metal control stent and a particularly low retreatment rate of 5.3 percent reinforce the safety and efficacy of the Taxus drug-eluting stent.

[T]he data from these two trials indicate that drug-eluting stents can be used safely in the setting of primary PCI [percutaneous coronary intervention] and are likely to reduce the need for repeated revascularization, NEJM wrote in its editorial. The editorial also cautioned that [i]t would be dangerous to conclude from these data that one drug-eluting stent is better than the other in primary PCI, since direct comparisons of the two stents for this indication are not available. The editorial noted that the retreatment rates for the Taxus stent in the PASSION study and for the Cypher stent in the TYPHOON study were remarkably similar at 5.3 percent and 5.6 percent, respectively. As indicated by the editor, differences in study design, definitions of endpoints and study conduct did not allow any side-by-side comparisons for the two different DES technologies in this clinical setting.

The PASSION trial showed that in AMI patients, the Taxus stent achieved reductions in cardiac death (3.9 percent for the Taxus stent versus 6.2 percent for the bare-metal control), target lesion revascularization (5.3 percent for the Taxus stent versus 7.8 percent for bare metal) and reinfarction (1.7 percent for the Taxus stent versus 2.0 percent for bare metal). While not adequately powered to provide statistical significance, this study supports the safety and efficacy of the Taxus stent technology in AMI. Boston Scientific is currently providing financial support for a randomized, controlled clinical trial designed to compare Taxus stents to bare-metal stents in AMI patients. The 3,400-patient definitive HORIZONS AMI trial is powered to confirm the benefits of the Taxus stent in AMI.
In the PASSION trial, the rate of angiographically confirmed stent thrombosis for the Taxus stent (1.0 percent) was low and no different from the bare-metal control stent.

Abbott™s Xience V Drug-Eluting Coronary Stent Superior To Taxus® Stent in SPIRIT II Clinical Trial
Positive six-month results of Abbott™s SPIRIT II clinical trial of the Xience V Everolimus Eluting Coronary Stent System were presented at the World Congress of Cardiology conference in Barcelona, Spain. Results of the trial, which was conducted in Europe and Asia Pacific, demonstrated superiority of the Xience V stent system compared to the Taxus® paclitaxel-eluting coronary stent system with respect to the study™s primary endpoint, which was angiographic in-stent late loss at six months (0.11 ± 0.27 mm for Xience V vs. 0.36 ± 0.39 mm for Taxus, p<0.0001).
Secondary endpoints of the trial also demonstrated positive results for the Xience V stent system, including a statistically significant reduction in percent diameter stenosis from 21 percent for Taxus to 16 percent for Xience V (p<0.001). The in-stent angiographic binary restenosis rate for Xience V was 1.3 percent compared to 3.5 percent for the Taxus control. Angiographic binary restenosis is the percentage of patients with occlusions 50 percent or greater at the time of six-month follow-up. The six-month MACE rate for the Xience V stent was 2.7 percent, versus 6.5 percent for the Taxus stent. As defined in SPIRIT II, the MACE rate includes any deaths, heart attacks or clinically driven target lesion revascularizations within the six-month period. The study also showed a stent thrombosis rate for Xience V of 0.5 percent (n=1) at six months compared to 1.3 percent (n=1) for that of Taxus. The device and procedural success rates for the Xience V stent system were 98.8 and 99.1 percent, respectively.

The excellent results demonstrate that in this trial, the Xience V stent was not only non-inferior but was also superior to the Taxus stent, and confirm the positive results from the SPIRIT FIRST study, said Prof. Patrick W. Serruys, MD, of the Thoraxcenter, Erasmus University Hospital, Rotterdam, principal investigator of the SPIRIT II clinical trial.

Xience V, which has received CE Mark approval, is currently an investigational device in the United States and Japan. The system utilizes everolimus, which has been shown to reduce tissue proliferation in the coronary vessels following stent implantation, and is based upon the Multi-Link Vision® coronary stent platform.
SPIRIT II is a 300-patient randomized, single-blind, prospective clinical trial evaluating Xience V versus the Taxus paclitaxel-eluting coronary stent system. Results of the SPIRIT II trial will provide additional clinical data to support the launch of Xience V in several countries outside the United States.

The SPIRIT FIRST study of the Xience V Stent System showed positive results through two years with no MACE events between one and two years for patients with de novo native coronary artery lesions. SPIRIT II and SPIRIT III are large-scale pivotal clinical trials comparing Xience V to the Taxus paclitaxel eluting coronary stent system. SPIRIT IV, which recently enrolled its first patient, will evaluate the safety and efficacy of the Xience V Stent System for the treatment of coronary artery disease in a more complex patient population in the United States. SPIRIT V is a planned international clinical trial that will provide additional clinical experience with Xience V in approximately 3,000 patients at 100 clinical sites throughout Europe, Asia, Canada and Latin America.

Abbott Vascular's drug-eluting stent program consists of two products: the XIENCE V Everolimus Eluting Coronary Stent System and the ZoMaxx Drug-Eluting Coronary Stent System. Both systems include stent platforms and controlled release of a drug from the -olimus class. The ZoMaxx drug-eluting stent system features zotarolimus, a compound proprietary to Abbott, and Abbott's TriMaxx stainless steel and tantalum stent platform, which has received CE Mark approval and is available for sale in Europe and select other geographies. ZoMaxx is an investigational device in Europe and in the United States. Abbott Vascular is also developing a bioabsorbable drug-eluting stent and drug-eluting stents that release a combination of drugs.

In April 2006, Abbott acquired the vascular intervention and endovascular solutions businesses of Guidant Corporation.

FoxHollow Announces First Patient Treated with The NightHawk System, A Technology Enabling Real-Time Visualization During Arterial Plaque Excision of the Lower Extremities
FoxHollow Technologies, Inc. announced the first-in-man use of a new imaging technology designed to provide real-time visualization during plaque excision procedures. The company™s latest device, called NightHawk, combines optical coherence tomography (OCT) technology with the FDA-cleared SilverHawk Plaque Excision System to allow for plaque removal with real-time imaging for patients suffering from blocked arteries in the lower extremities. The NightHawk technology is currently being evaluated through a feasibility study at a hospital in Poland.
The first 5 patients have been treated at the American Heart of Poland Hospital in Bielsko. Data from the procedures will be used to evaluate the ability of the NightHawk to image and treat arteries in the lower leg, and to correlate the OCT images with traditional angiographic images and histology results. A team of U.S. interventional cardiologists including FoxHollow founder and CEO, Dr. John Simpson, Dr. Stefan Kiesz and Dr. Greg Robertson attended the cases. Professor Pawel Buszman is the lead Principal Investigator.

These initial procedures with the NightHawk are very encouraging and consistent with our experience in pre-clinical studies. They demonstrate the tremendous potential for real-time visualization to enhance procedural results obtained with the SilverHawk for treating patients suffering from PAD, Simpson commented. As a result, we believe the NightHawk may significantly enhance our ability to treat PAD patients in the near-term and may someday allow us to treat patients suffering from blocked arteries in the heart.

The NightHawk System utilizes fiber optic technology embedded in the catheter. While removing plaque, the physician has the ability to visualize the intravascular placement of the device within the vessel. Additional advantages of OCT include the reductions in the use of x-ray imaging and contrast media.

NCDR Launches CARE Registry
The National Cardiovascular Data Registry (NCDR) has launched the new Carotid Artery Revascularization and Endarterectomy (CARE) Registry. Developed in partnership with the Society for Cardiovascular Angiography and Interventions (www.scai.org), the CARE Registry is designed so that hospitals meet CMS data collection requirements for Medicare reimbursement. The CARE Registry is a tool for measuring, evaluating and improving patient care for carotid artery stent placement and endarterectomy procedures. The Registry allows retrospective data collection, including data beginning at the time of CMS™ March 2005 coverage decision. It offers optional data collection for carotid endarterectomy procedures.

A multidisciplinary physician team, including cardiologists, neurologists, invasive radiologists, vascular surgeons and other specialists, helped design the CARE Registry, which includes an independent stroke assessment. The CARE Registry collects data for 30-day patient follow-up. More information is available at www.accncdr.com.