Clinical and Industry News

Black Patients Have Lower Rate of Survival After In-Hospital Cardiac Arrest

Compared with white patients, black patients who have an in-hospital cardiac arrest are significantly less likely to survive to hospital discharge, having lower rates of successful resuscitation and postresuscitation survival, although much of this survival difference was associated with the hospital in which black patients received care, according to a study in the September 16 issue of JAMA. “Survival following in-hospital cardiac arrest represents a unique opportunity to examine racial disparities in medical care and outcomes. In-hospital cardiac arrest is an emergency condition tightly linked to processes of care and for which there is little debate regarding clinical appropriateness of treatment in eligible patients,” according to background information in the article. “Racial differences in survival have not been previously studied after in-hospital cardiac arrest, an event for which access to care is not likely to influence treatment.” Paul S. Chan, MD, MSc, of Saint Luke’s Mid America Heart Institute, Kansas City, Mo., and colleagues used data from the National Registry of Cardiopulmonary Resuscitation (NRCPR) to examine whether racial differences exist in survival for patients with in-hospital cardiac arrest. The study included 10,011 patients from 274 hospitals who underwent defibrillation for a cardiac arrest. The average age in the study population was 67 years, 6,021 were men (60.1 percent), and 1,883 were black (18.8 percent). Several patient and hospital factors differed by race, including white cardiac arrest patients being older and more likely to be male; black patients were more likely to have ventricular fibrillation as their initial presenting arrest rhythm, were sicker at the time of cardiac arrest (higher rates of renal insufficiency, diabetes mellitus, central nervous system depression, acute stroke, pneumonia, sepsis, major trauma, and requirement for hemodialysis), and were more likely to be admitted to a hospital unit not monitored, to a hospital with greater than 500 beds, and in the southeastern United States. The researchers found that black patients had a 27 percent lower overall rate, and a 12 percent lower absolute rate, of survival to hospital discharge, compared with white patients. “These unadjusted survival differences by race were, in large part, attributable to black patients being more likely to receive treatment at hospitals with worse outcomes.” These differences narrowed after adjusting for patient characteristics and for the hospital to which the patient was admitted. “However, further adjustment for hospital process variables did not meaningfully [diminish] residual differences, and black patients remained 10 percent less likely to survive to hospital discharge,” the authors note. “Lower rates of survival to discharge for blacks reflected lower rates of both successful resuscitation (55.8 percent vs. 67.4 percent for whites) and postresuscitation survival (45.2 percent vs. 55.5 percent for whites),” they write. “The racial difference in postresuscitation survival was eliminated after multivariable adjustment, and was largely explained by the hospital site at which patients received postresuscitation care.” “Collectively, these findings suggest that strategies to eliminate racial disparities in survival after in-hospital cardiac arrest are not likely to succeed unless they are accompanied by successful identification and implementation of interventions that improve resuscitation survival in those poorly performing hospitals in which black patients are more likely to receive care.” Source: JAMA 2009;302[11]:1195-1201. ______________________

New Large-Scale, Global Study Provides Additional Information About an Intensified Dose-Regimen of Clopidogrel in ACS Patients Undergoing Angioplasty

The OASIS study group presented initial results of the CURRENT-OASIS 7 clinical trial at the European Society of Cardiology Congress in Barcelona. Sanofi-aventis and Bristol-Myers Squibb, co-commercialization and co-development partners for clopidogrel bisulfate (Plavix®), were sponsors of the study. CURRENT-OASIS 7 is the largest clinical trial (25,087 patients) to evaluate different dosing regimens of clopidogrel plus aspirin in a broad range of acute coronary syndrome (ACS) patients (UA/NSTEMI/STEMI). The study was designed to assess the efficacy and safety of an intensified clopidogrel regimen (600 mg loading dose day 1/150 mg days 2-7/75 mg days 8-30) versus the approved clopidogrel dosage (300 mg loading dose day 1/75 mg days 2-30) for patients managed with an early invasive strategy with an intent for percutaneous coronary intervention (PCI). The primary endpoint (cardiovascular death, heart attack, or stroke at thirty days) for the entire study population (including subpopulations of patients that underwent PCI (70%) or not (30%) examining the difference between the high-dose and standard-dose clopidogrel regimens did not reach statistical significance (4.2% vs. 4.4%, HR 0.95, p=0.37). For clinically relevant subgroups that were pre-specified for preliminary analyses, such as the PCI subgroup (70% of the trial population, 17,232 patients), potentially medically relevant differences in patient outcomes were observed. In this subgroup, analysis showed an improvement in outcome for patients taking the higher dose regimen (600 mg loading/150 mg for days 2-7/75 mg days 8-30) over the standard dose regimen (300 mg loading/75 mg for days 2-30), as shown by the reduction of the same composite endpoint of cardiovascular death, myocardial infarction and stroke by 15% (4.5% vs 3.9%, p=0.037). In addition, analysis showed an important 42% relative risk reduction in definite stent thrombosis (1.2% vs 0.7%, p=0.001) with the higher dose regimen of clopidogrel over the standard loading dose. The primary safety endpoint was assessed by the stringent bleeding definition of OASIS and while a significant increase in the primary safety endpoint of major bleeding with the high-dose compared to the standard-dose clopidogrel regimen was observed in the overall trial population (2.5% vs 2.0%, HR 1.25, p=0.01) and the PCI population (1.6% vs 1.1%, HR 1.44, p=0.006), there was no statistically significant difference in intracranial bleeding or fatal hemorrhage in the overall population and the PCI population. ______________________

Philips Launches Technology Using Gender-Differentiated Criteria for the Diagnosis of Female Heart Disease

Royal Philips Electronics recently unveiled the PageWriter TC50 cardiograph, which uses gender-differentiated criteria to assist in the diagnosis of heart disease in women, where symptoms may be different from men.1 The PageWriter TC50 had its global launch at the European Society of Cardiology (ESC) Congress 2009. Cardiovascular disease is the main cause of death in women in all countries of Europe.2 One in five European women die from coronary heart disease2 and by 2020, coronary heart disease among women globally will have increased by 120 percent from the levels of 1990.3 Women are more likely than men to have a second heart attack within six years of the first and are 50 percent more likely than men to die in the first year after a heart attack.4 Tests for diagnosing coronary artery disease have been traditionally developed and tested in men. For example, women make up only 38 percent of the participants in cardiovascular studies funded by the National Institutes of Health in the US.5 But women with coronary artery disease often complain of different symptoms from men1 and show clinical differences as well, with damage more often occurring in smaller blood vessels with fewer arterial blockages, a condition called microvascular disease.6 As a result, more women than men with heart conditions can show normal vessels in spite of their worsening symptoms.7 Negative or unclear tests in women can often mean heart disease goes missed and untreated. Philips has been developing diagnostic tools which take gender differences into account since the 1970s.8 The PageWriter TC50’s analysis program, the DXL Algorithm, uses different criteria for men and women to help clinicians interpret cardiac symptoms, including identifying acute global ischemia. Philips provides healthcare professionals with comprehensive diagnostic tools which respond to recommendations by the American Heart Association, the American College of Cardiology Foundation and the Heart Rhythm Society for myocardial infarction and acute ischemia, including gender and age-specific criteria.9 References 1. McSweeney JC, Cody M, O’Sullivan P et al. Women’s early warning symptoms of acute myocardial infarction. Circulation 2003;108:2619-2623. 2. Allender S, Scarborough P, Peto V et al. European cardiovascular disease statistics 2008. European Heart Network 2008: 1-112. 3. Murray CJL, Lopez AD, eds. The global burden of disease: a comprehensive assessment of mortality and disability from diseases, injuries and risk factors in 1990 and projected to 2020. Cambridge, MA: Harvard University Press on behalf of the World Health Organization and the World Bank 1996. 4. Texas Heart Institute. https://www.texasheart.org/HIC/Topics/HSmart/women.cfm. 5. Harris DJ, Douglas PS. Enrollment of women in cardiovascular clinical trials funded by the National Heart, Lung, and Blood Institute. New England Journal of Medicine 2000; 343:475-480. 6. Mayo Clinic Health Letter. Small vessel heart disease. October 2007; 25(10):1-3. 7. Bugiardini R, Bairey-Merz CN. Angina with "normal" coronary arteries: a changing philosophy. Journal of American Medical Association 2005; 293:477-484. 8. Internal data from Philips. 9. American Heart Association/American College of Cardiology Foundation/Heart Rhythm Society. Recommendations for the standardization and interpretation of the electrocardiogram, Part VI: Acute ischemia/infarction. Circulation 2009;100:e262-e270. ______________________

ACC-NCDR Shows Santa Rosa Memorial Hospital’s Rapid Heart Attack Response as #1 of 949 U.S. Hospitals

Local specialists in cardiovascular care, emergency medicine and emergency medical services have methodically reduced the time needed to diagnose serious heart attacks and restore blood flow to the heart, an advancement that earned Santa Rosa Memorial Hospital, Santa Rosa, Ca., a #1 ranking out of 949 U.S. hospitals tracked for “door-to-balloon time” by the American College of Cardiology Foundation’s National Cardiovascular Data Registry (ACC-NCDR). Recent improvements initiated by Coastal Valleys Emergency Medical Services and Santa Rosa Memorial Hospital have resulted in door-to-balloon times that consistently beat the national standard of care, 90 minutes or less.* “Every minute counts,” said Trish Scalercio, RN, cath lab manager at Memorial Hospital. “The quicker we restore blood flow to the heart, the greater the patient’s chances of survival, full recovery and minimized heart muscle damage.” During the first three months of 2009, the hospital’s door-to-balloon time averaged 66 minutes, hospital records show. Heart attack patients suffering an acute myocardial infarction (STEMI) benefited from door-to-balloon times under 90 minutes in 100% of all cases handled at Santa Rosa Memorial between January and March. This places Memorial’s door-to-balloon time as the highest-ranking out of 949 U.S. hospitals that participate in the American College of Cardiology Foundation’s National Cardiovascular Data Registry, according to the most recently released report issued this summer. The quarterly report tracked patient outcomes for January through March. Patients and their loved ones have benefited from coinciding initiatives by Coastal Valleys EMS and Santa Rosa Memorial, both concentrated on speeding detection of major heart attacks in the field so a multidisciplinary team at the hospital is on alert, standing by to rapidly administer medications, tests and life-saving interventions when the ambulance arrives. When Coastal Valleys began piloting an early STEMI detection program in 2006 with local hospitals, “we set a loftier goal than 90 minutes’ door-to-balloon time,” said Bryan Cleaver, Regional EMS Administrator of Coastal Valleys EMS, an agency serving Sonoma, Napa and Mendocino counties. “We wanted a 90-minute limit between detection of STEMIs by paramedics treating patients at their homes or in the community and any cath lab intervention. For us, it’s home-to-balloon time.” Historically, confirmation that patients were suffering a STEMI often was not made until after a patient’s arrival at the emergency department. But thanks to a widespread upgrade in cardiac monitoring — with most local paramedics now using a 12-lead electrocardiogram to evaluate patients after a 911 call — notification to hospitals to activate their STEMI team is occurring faster, well before a patient reaches the emergency department. “When the patient arrives, all the people who need to care for that patient are waiting at the bedside and the cath lab is ready to go,” said Denise Thomas, RN, Emergency/Critical Care Services Clinical Nurse Specialist in Memorial’s emergency department. The opening in November 2008 of Memorial’s new Heart & Vascular Institute, positioned immediately adjacent to the emergency department, helped Memorial’s clinical staff shave 2 to 5 minutes off typical treatment times for heart attack patients. But it was the coordinated effort of cardiologists, emergency physicians and nurses — who each month studied previous patients’ charts to search out opportunities to expedite care — that made the more crucial impact. Emergency eepartment doctors and nurses worked closely with lab, x-ray and respiratory care professionals to reduce pre-cath lab prep time to as few as 13 minutes in some cases, Thomas said. Thanks to streamlined triaging by paramedics and the emergency team, cath lab experts also were better equipped to cut wait times for high-risk patients in need of balloon angioplasty, stenting and other emergency procedures. Cabinet maker Carl Mannle, 66, is among patients whose rapid door-to-balloon time — 38 minutes after he suffered a heart attack at his home in Sonoma in November — enabled him to recover without long-term damage to his heart muscle. Mannle had been reading the newspaper on his home computer at 8 am that autumn morning when suddenly he felt “unbelievably ill, like the worse case of flu your body ever felt,” he remembered. “I got up to walk down the hall and it just hit, bang.” Within minutes of his daughter’s 911 call, paramedics arrived, gave Mannle a chewable aspirin and confirmed with the 12-lead electrocardiogram (ECG) that he was suffering an acute myocardial infarction. The 25-minute drive by ambulance brought him to Memorial’s emergency department, then on directly to the cath lab, where he underwent angioplasty and stenting. “The paramedics were in radio contact with the hospital and everything was all set up and ready when they got me there,” Mannle said. “I got excellent care. The success of my treatment to a very great extent had to do with the expediency of the treatment. Everything proceeded with no delays.” ______________________

Terumo Interventional Systems Announces Line Expansion of Its Pinnacle® Destination® Guiding Sheaths

8 French Size Extends Product Use in Atherectomy and Stent Graft Procedures Terumo Interventional Systems announced the expansion of its Pinnacle® Destination® Guiding Sheaths. The introduction of the 8F Destination Guiding Sheath extends the range of interventional procedures that can be performed by this product to include atherectomy and stent graft procedures. The Pinnacle Destination Guiding Sheath line supports virtually all applicable diagnostic and interventional procedures. A comprehensive range of French sizes (5F–8F), lengths and tip shapes are offered, as well as two different valve types. The Pinnacle Destination design includes an atraumatic tip, which minimizes the potential for vessel damage, allows smooth transition from guidewire to dilator and dilator to sheath, helping to ensure easy penetration without force. The sheath has a hydrophilic coating on a nylon outer layer, with a PTFE inner layer and stainless steel coil. Susan Anderson, Marketing Manager, Lesion Access, said, “The 8F size is a direct result of physician input and demand for this product in addressing the surging number of limb salvage and stent graft cases.” For more information, visit https://www.terumois.com. ______________________

Stop Moving Dirty Equipment: Save Money, Increase Direct Patient-Care Time, Reduce the Spread of Germs

Applying lean management techniques to the use and maintenance of mobile patient critical use equipment (CUE) saves time and money, increases direct patient care time, and could be helpful in reducing hospital-acquired bacterial infections such as MRSA, C.Diff, and VRE, suggests Allen Caudle, a partner with Appleseed Healthcare Resources. “Critical use equipment is typically moved from use site to housekeeping facilities for sterilization. The results: Typically, CUE is not at the point of use. The ramifications of this common practice are many — all of which are negative: time wasted searching for needed equipment, frustrated staff, time and money spent monitoring wayward equipment and cleaning warehoused dirty equipment, and increased patient risk of infection (and attendant costs) from germs spread on unclean equipment traveling between locations,” stated Mr. Caudle. “Whether in a diagnostic or interventional cath lab, keeping CUE at the point of use maximizes efficiency, which saves time and money, increases the time available for direct patient care, and prevents the spread of germs, which, in turn, lowers the risk of infection for staff and patients alike; it’s a huge win, easily accomplished, for all involved,” he continued. Mr. Caudle offers the following lean management process for using and maintaining CUE at the point of use. Assess Use. Decide what equipment is needed in each cath lab, by area. If any piece of equipment is used 60% of the time or more, keep it at the site. Maintain at the Point of Use. Establish cleaning protocols with input from infection control. Instruct and train all appropriate employees to follow the new procedures. Store at the Point of Use. Identify/ create a location within each cath lab for clean safety stock and CUE used 40% of the time or less. Create another, separate location for dirty safety and/or lesser used CUE for maintenance to be followed with return to clean area following proper maintenance and cleaning. Monitor Movement. All needed equipment should be at the point of use, either in the lab (equipment used 60% or more of the time) or in a clean storage facility (equipment used 40% of the time or less) on the unit. There are only three valid reasons for a piece of equipment to leave its “home” area: • Patient transfer; • Breakage; • Preventive maintenance. Equipment should be monitored by supply chain personnel two to three times per day to ensure that clean, usable equipment in the determined necessary amount is continually available at the point of use. Establish a Task Force. Create a multi-disciplinary team consisting of representatives from nursing, epidemiology, supply chain, bio-med, and housekeeping/environmental services to participate in the implementation of the new process and engage all parties involved. Obtain Corporate Buy-In. Involve senior-level cath lab administration to champion the new paradigm to the c-suite. Conduct a Trial. Establish the new paradigm in several key labs to evaluate the new approach and work out issues before rolling it out system-wide. Sustainability. Establish metrics to score progress and ensure processes are being followed. Created in 2002, Appleseed Healthcare Resources is a partnership of senior healthcare executives dedicated to empowering providers with innovative strategies and the knowledge, skills, and tools necessary to achieve tangible and sustainable operational excellence. Additional information may be found at https:// www.appleseedhc.com.

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