Clinical and Industry News

Lumedx and Mennen Medical® Announce Agreement for a Strategic Cooperation

Partnership marries Lumedx’s CVIS and PACS software modalities with Mennen Medical’s hardware products for the cath lab Lumedx Corporation and Mennen Medical® signed a strategic partnership agreement to provide an integrated cath lab data solution and hemodynamic cardiovascular patient data to their customers. Lumedx is a cardiovascular information system and PACS provider serving more than 500 hospitals worldwide. With a presence in over 50 countries worldwide, Mennen Medical offers patient monitoring, hemodynamic monitoring systems and electrophysiology recording systems. The agreement combines into one integrated system the CVIS and PACS software modalities of Lumedx with Mennen Medical’s suite of hardware products for the cath lab, including its new hemodynamic system, the Horizon XVu, patient monitoring and EP recording systems. Mennen Medical’s new XVu System is embedded with an interface and analysis system enabling various layouts for cardiac and peripheral angiography procedures, including a pediatric package. Mennen Medical’s proprietary front-end vital signs acquisition unit, the CFE, can be rail-mounted on the procedure table for maximum space utilization and comfort. The Lumedx CardioStar™ Cardiovascular Information System (CVIS) provides a data and image management environment for cardiology, cardiac surgery and vascular medicine. Built around the Apollo Advance™ clinical data repository, the CardioStar application suite offers physician reporting, image archiving, scheduling, inventory control, charge capture and data analytics. In addition, the company’s new HealthView Network provides a community-wide information infrastructure, allowing physicians to access the complete cardiovascular hospitalization record from home or office, via any internet-connected computing device. _______________________________

Two-Year Results of Abbott’s Fully Bioabsorbable Drug-Eluting Stent Published

Absorbed within two years, leaving behind blood vessels that appear to move and function similar to untreated vessels A comprehensive analysis published in The Lancet from the ABSORB clinical trial demonstrated that Abbott’s bioabsorbable drug-eluting stent, currently in development, successfully treated coronary artery disease and was absorbed into the walls of treated arteries within two years. The two-year data also demonstrated that after the bioabsorbable device was absorbed, the treated blood vessels appeared to move and function similar to unstented arteries. Preliminary findings from the 30-patient ABSORB trial were presented in October 2008 at the Transcatheter Cardiovascular Therapeutics annual meeting in Washington, D.C. The ABSORB trial is the world’s first clinical trial evaluating a fully bioabsorbable drug eluting coronary stent, and advanced imaging methods were used to assess patient outcomes. The first phase of the ABSORB trial demonstrated the following key results: • A zero percent rate of stent thrombosis for all patients out to two years of follow up. • No new major adverse cardiac events (MACE) between six months and two years. At two years, the bioabsorbable device demonstrated a MACE rate of 3.6 percent (one patient). MACE is defined as any event that resulted in re-treatment of the treated artery lesion, heart attack or cardiac death. • Bioabsorption of the stent at two years after implantation, as confirmed by an assessment of the stent struts using optical coherence tomography (OCT). • Restoration of vasomotion (ability of the blood vessel to contract and expand) was observed at two years, with the drug acetylcholine used in nine patients showing vasodilation in the previously stented area, and the drug methergin used in seven patients showing vasoconstriction in the previously stented area. • Reduction in plaque area in treated arteries, corresponding to an increase in blood flow between six months and two years, as confirmed by intravascular ultrasound (IVUS) and virtual histology. Abbott’s bioabsorbable everolimus eluting coronary device is made of polylactic acid, a biocompatible material commonly used in medical implants such as dissolvable sutures. Abbott will begin enrolling patients in the second phase of its international ABSORB clinical trial in the first half of 2009. The ABSORB trial is a prospective, non-randomized (open label), two-phase study designed to enroll approximately 110 patients in Australia, Belgium, Denmark, France, the Netherlands, New Zealand, Poland and Switzerland. Key endpoints of the study include assessments of safety — MACE and stent thrombosis rates — at 30 days, six, nine and 18 months, and one and two years, with additional annual clinical follow up for up to five years, as well as an assessment of the acute performance of the bioabsorbable drug-eluting stent, including successful deployment of the stent. Other key endpoints of the study include imaging assessments by angiography, IVUS, OCT, and other state-of-the-art invasive and non-invasive imaging modalities at six and 18 months, and at one or two years. _______________________________

Vascular Solutions Launches Flamingo™ Inflation Device and Interventional Packs

Vascular Solutions, Inc. recently announced its partnership with Sedat and the launch of the Flamingo inflation device. The Flamingo is designed for use during cardiovascular procedures to create, maintain and monitor pressures up to 30atm in a compact 20cc syringe. The Flamingo offers progressive inflation resistance while providing constant pressure feedback during inflation. It also features an ergonomic design with a 90° rotating gauge for customized handling, and it is constructed of clear materials to ensure visualization of air bubbles. The Flamingo inflation device comes with an optional 3-way stopcock and Alligatork™ torque device. Vascular Solutions also offers interventional packs complete with a Flamingo inflation device, a Guardian® hemostasis valve and other optional accessories. Developed and manufactured by Sedat, the Flamingo is currently available in the United States through Vascular Solutions’ sales force. For more information, visit www.vascularsolutions.com. Flamingo™ and Alligatork™ are trademarks of Sedat. Guardian® is a registered trademark of Zerusa Ltd. _______________________________

PROTECT I Study Results Published for Abiomed Impella 2.5

Results from the PROTECT I trial evaluating the feasibility and effectiveness of the Abiomed, Inc. Impella 2.5 circulatory assist device in high-risk percutaneous coronary intervention (PCI) procedures have been published in the February issue of the Journal of the American College of Cardiology (JACC). The study concludes that “The Impella 2.5 system is safe, easy to use, and provides excellent hemodynamic support during high-risk PCI.” The PROTECT I trial enrolled 20 patients undergoing high-risk PCI at seven centers between July 2006 and April 2007. Eligible patients had left ventricular ejection fraction (EF) of less than 35% and were required to undergo PCI on either an unprotected left main coronary artery or the last patent coronary conduit. “The Impella 2.5 is poised to change the standard of care in our efforts to combat heart disease and its devastating after-effects,” said Igor F. Palacios, MD, Director of Interventional Cardiology, Massachusetts General Hospital, Boston, MA, Associate Professor of Medicine at Harvard University Medical School and participating cardiologist in the Protect I trial. “The PROTECT I trial enrolled a very sick patient population, and demonstrated that the device works and validated its impressive safety profile, showing no valve, blood or vascular damage, no instances of stroke and a low adverse event rate.” The Impella 2.5 received 510(k) clearance from the FDA in June 2008 for partial circulatory support for periods up to six hours. It is inserted percutaneously in the catheterization lab via the femoral artery into the left ventricle. Up to 2.5 liters of blood per minute is delivered by the pump from the left ventricle into the ascending aorta, providing the heart with active support in critical situations. Now approved in more than 40 countries, including in Europe under the CE Mark, the Impella 2.5 has been used to treat over 1,700 patients worldwide and has been the subject of more than 50 peer-reviewed publications. Abiomed is also currently conducting two U.S. pivotal studies comparing the Impella 2.5 to the IABP (PROTECT II for high-risk PCI and RECOVER II for acute myocardial infarction, AMI). There are an estimated 60,000 annual high-risk PCI patients and 100,000 AMI anterior infarct patients annually in the United States. The study may be accessed online at: https://interventions.onlinejacc.org/cgi/content/full/2/2/91 _______________________________

Combined Use of Antiplatelet, Gastric Acid Medications Following Heart Attack or Angina Associated With Increased Risk of Death, Hospitalization

Following an acute coronary syndrome such as a heart attack or unstable angina, patients who receive a medication to reduce the risk of gastrointestinal bleeding that may be associated with the use of the antiplatelet drug clopidogrel and aspirin have an increased risk of subsequent hospitalization for acute coronary syndrome or death, according to a study in the March 4 issue of JAMA. Treatment with clopidogrel in addition to aspirin reduces recurrent cardiovascular events following hospitalization for acute coronary syndrome (ACS) for patients treated either medically or with angioplasty or stent placement. Proton pump inhibitor (PPI) medications are often prescribed at the start of treatment with clopidogrel, with the goal of reducing the risk of gastrointestinal tract bleeding while patients are taking dual-antiplatelet therapy. Recent studies, however, suggest that PPIs may reduce the effectiveness of clopidogrel, but the clinical significance of these findings to patients is not clear. P. Michael Ho, MD, PhD, of the Denver VA Medical Center, and colleagues evaluated the use of clopidogrel plus PPI following hospital discharge for ACS and compared rates of all-cause death and rehospitalization for ACS, between patients taking clopidogrel plus PPI vs. clopidogrel without PPI. The study included patients from 127 Veterans Affairs hospitals. Vital status information was available for all patients through September 30, 2006. Use of clopidogrel plus PPI at any point in time was associated with a 25% increased odds of death or rehospitalization for acute coronary syndrome (ACS) compared with use of clopidogrel without PPI. For the individual outcomes, the rates of recurrent hospitalization for ACS (14.6 percent vs. 6.9 percent) and revascularization procedures (15.5 percent vs. 11.9 percent) were higher among patients taking clopidogrel plus PPI compared with those taking clopidogrel without PPI. However, the risk of death was similar between the two groups. “When patients were not taking clopidogrel after hospital discharge, a prescription for PPI was not associated with death or rehospitalization for ACS, supporting the hypothesis that the interaction of PPI and clopidogrel, rather than PPI itself, was associated with increased adverse outcomes,” the authors write. “… this study raises some concern about concomitant use of PPI medications and clopidogrel following hospitalization for ACS. While the risk estimates associated with clopidogrel plus PPI vs. clopidogrel without PPI were modest, the absolute number of adverse events attributable to this potential drug interaction is considerable when extrapolated to a population level, given how frequently PPI medications are prescribed to patients receiving dual-antiplatelet therapy,” the researchers write. “Pending additional evidence, however, the results of this study may suggest that PPIs should be used for patients with a clear indication for the medication, such as history of gastrointestinal tract bleeding, consistent with current guideline recommendations, rather than routine prophylactic prescription. Alternative gastrointestinal tract medication regimens also may be considered until additional data regarding concomitant use of PPI and clopidogrel becomes available.” Source: JAMA 2009;301[9]:937-944. _______________________________

Cardiac Cath Lab Directors Say CVIS Delivers Limited Financial Benefits, Satisfaction Levels

Cardiovascular information systems (CVIS) are not delivering quantifiable financial benefits, according to cardiac cath lab directors who participated in an independent national survey completed in January on behalf of Wolters Kluwer Health and ProVation Medical. The survey of hospital cardiac cath lab directors was designed to measure the use and satisfaction levels with CVIS and procedure documentation systems. Thirty-one percent of cardiac cath lab directors reported no quantifiable improvements in revenues or the revenue cycle since implementing CVIS, due in part to continued reliance on dictation for physician documentation. Overall, 69% of respondents reported that physicians continue to dictate, despite clinical procedure documentation for physicians being identified by 51% of cardiology directors as an “extremely important” CVIS feature. Four in 10 cardiac cath lab directors whose physicians dictate felt that documentation issues have at least a “moderate” impact on revenues. One-fourth also estimated that they could realize an annual savings of $100,000 or more by eliminating the costs associated with dictation and transcription. The majority of respondents reported being only “somewhat satisfied” or “satisfied” with CVIS. Lower satisfaction rates were most closely associated with problems interfacing with other systems and hardware (10%); failure to function as promised (8%); not user-friendly (7%); poor vendor support (6%); and failure to offer a comprehensive array of features (5%). Of the 31% who reported using software for procedure documentation, fewer than one in five said the application produced automatic CPT and ICD codes based on that documentation. As a result, 22% reported no quantifiable increase in revenues since implementing the documentation solution. However, interest in clinical documentation software remains high. The majority (68%) of those whose physicians currently dictate said it was at least “somewhat likely” that they would implement physician procedure documentation within the next two years. Among the features identified as having the most influence over that purchasing decision were the ability to streamline workflows and increase efficiencies (88%), ease-of-use (86%) and physician satisfaction rates (72%). ProVation MD software for procedure documentation and coding compliance replaces dictation/transcription and streamlines the coding and billing process. Unlike Cardiovascular Information Systems (CVIS), which collect patient measurements and administrative data, ProVation MD allows clinicians to document medical procedures at the point of care, then applies reimbursement codes to drive compliance and revenue recovery. ProVation MD interfaces with cardiovascular nursing, imaging and measurement systems to complete the electronic documentation process and free busy cardiologists and technologists from time-consuming dictation. Renaissance Research, of Edwardsville, IL, conducted the national online survey Jan. 13-25, 2009. The survey was completed by 151 hospital cardiology and cardiac lab directors, providing a margin of error of +/- 8 percentage points. _______________________________

Large-Scale Data Show Carotid Artery Stenting Achieves AHA Guideline Standards for 30-Day Safety

SCAI Applauds CMS Move to Revisit Decision on Expanded Coverage for Carotid Artery Stenting Carotid artery stenting (CAS) has demonstrated outcomes consistent with the American Heart Association’s (AHA) long-established guidelines for treatment of patients who have blockages in their carotid arteries and are at risk for standard carotid surgery, according to an analysis of two large, prospective studies published online in Circulation: Cardiovascular Interventions. The Society for Cardiovascular Angiography and Interventions (SCAI) applauds action by the Centers for Medicare and Medicaid Services (CMS) to revisit its decision on expanded coverage for CAS. Expanded coverage of CAS to include all Food and Drug Administration (FDA)–approved indications would provide additional treatment options for a larger group of patients who are at risk for stroke. This would reverse the agency’s Oct. 16, 2008, decision not to expand coverage of CAS at that time, which cited a lack of published, peer-reviewed data. The newly published analysis looked at results from two post-market studies, CAPTURE 2 and EXACT, examining the safety and effectiveness of two different FDA-approved carotid stent and embolic protection systems. Data show both symptomatic and asymptomatic patients undergoing CAS achieved the outcomes recommended by the AHA for 30-day death and stroke rates for carotid endarterectomy. This standard surgical procedure to remove carotid artery blockages has not been subjected to the same level of scrutiny in these at-risk patients. “Previously, neither surgery nor CAS had demonstrated these outcomes in a multi-center, prospective trial of high-surgical-risk patients,” said William A. Gray, MD, director of the Endovascular Services at the Center for Interventional Vascular Therapy, New York-Presbyterian Hospital and Columbia University. “In the 10 years since the AHA guidelines for carotid endarterectomy were published, there has not been a similarly rigorous study demonstrating that carotid endarterectomy meets these guidelines in high-risk patients.” “The results of CAPTURE 2 and EXACT extend results we’ve seen from the CAS studies in high-risk patients to those who have not yet suffered a stroke. It is exciting to learn the growing body of evidence demonstrates carotid stenting is as safe and effective as surgery in all patient groups,” said Steven R. Bailey, MD, FSCAI, SCAI president-elect. “The EXACT and CAPTURE 2 data strongly support the case that CAS should be considered an appropriate option to treat patients with carotid stenosis and surgical risks.” Currently, CAS is only covered by CMS in certain high-risk patients who cannot undergo surgery due to severe blockages or other factors, while surgery is fully covered. These data follow similar findings from the Stenting and Angioplasty with Protection of Patients with High Risk for Endarterectomy (SAPPHIRE Worldwide) trial, published in Catheterization and Cardiovascular Interventions in October 2008. The CCI data, coupled with the results of the CAPTURE 2 and EXACT trials, show an almost overwhelming case for the option to offer CAS to these patients. “The evidence in support of CAS is growing. These studies demonstrate that CAS should be considered an appropriate option to treat patients with carotid stenosis and increased surgical risks,” said Steven R. Bailey, MD, FSCAI, SCAI president-elect. “We applaud the CMS for revisiting its decision on expanding coverage of CAS, and we hope CMS will agree that patients and physicians should have a wider range of treatment options to best suit each patient’s specific condition.” The Society for Cardiovascular Angiography and Interventions’ patient and physician education program, Seconds Count, offers comprehensive information about cardiovascular disease. For more information about SCAI and Seconds Count, visit www.scai.org/. _______________________________

TZ Medical Inc. Announces the Addition of Natural Anti-Microbial Barrier Claim to Its Neptune Products

TZ Medical, Inc. announced the additional claim of “Natural Anti-Microbial Barrier” to its Neptune family of topical hemostatic devices, which include the Neptune pad, Neptune Disc, and Neptune Comfort Band. The claim of “Natural Anti-Microbial Barrier” is related to the natural characteristics of calcium alginate. Calcium alginate is the main component of the Neptune family of hemostatic products. “Having a natural anti-microbial barrier is an effective deterrent to hospital-acquired infections and should help our customers reduce their costs,” according to Thomas R. Tribou, President of TZ Medical, Inc. Additionally, Mr. Tribou went on to say “Millions of Neptune products have been used safely on patients around the world without any concern of adverse antibody reactions.” The Neptune families of hemostasis devices are made from calcium alginate, which is derived from seaweed. It is a natural product and does not incorporate any blood product derivatives, human or animal, which have been known to cause harmful antibody reactions in patients who have been exposed to them. Neptune works by accelerating the patient’s own clotting process by providing: • Additional calcium ions to speed topical clot formation. • Hydrophilic absorption of excess blood as it speeds the clotting process. • A textured matrix to facilitate clot formation. For more information, contact Valerie Meyer, 800/944-0187, valeriem@tzmedical.com. _______________________________

Boston Scientific Launches New Coronary Imaging Catheter

Boston Scientific Corporation announced the launch of its iCross™ Coronary Imaging Catheter, a product designed to improve the deliverability of the Company’s intravascular ultrasound (IVUS) technology, the iLab® Ultrasound Imaging System. The Company said the iCross Catheter would be available immediately in the United States. The iCross Catheter features a Bioslide® Hydrophilic Coating that has been shown in bench tests to provide a 28% improvement in pushability in challenging anatomy.1 1) Pushability is the amount of force required to push a catheter to a specific depth in the anatomy. Testing completed by Boston Scientific Corp. Data on file. Bench test results may not necessarily be indicative of clinical performance. Twenty-eight percent improvement as compared to Boston Scientific’s Atlantis SR Pro catheter. _______________________________

Vascular Solutions Launches GrebSet™ Micro-Introducer Kit

Vascular Solutions, Inc. recently announced the launch of its GrebSet, a micro-introducer kit with an angled tip that facilitates steerability. The GrebSet is a 30cm coaxial micro-introducer kit that allows the operator to direct an .035” or .038” guidewire into a vessel branch without having to exchange from a conventional access kit to an angled catheter after gaining access. Additional features include hydrophilic coating, a braided sheath and a radiopaque marker band embedded in the distal tip. Currently available in the U.S., the GrebSet comes packaged with an .018” nitinol guidewire and either a 21G 15cm Trocar needle or 7cm single-wall echogenic needle. For more information, visit www.vascularsolutions.com. _______________________________

Abbott Launches Voyager™ NC Coronary Balloon Catheter

Abbott announced the launch of Voyager™ NC Coronary Dilatation Catheter, a next-generation balloon dilatation catheter with high-pressure capability designed to optimize the treatment of patients with coronary artery disease (CAD) during angioplasty procedures. Voyager NC is now available in the United States, Europe and select countries in Asia and Latin America. Featuring Abbott’s proprietary technology, the new Voyager NC system can be used for both pre-dilatation and post-dilatation procedures. Physicians can use Voyager NC to navigate tortuous anatomy and open up lesions before a stent is delivered, or expand a stent more precisely against the vessel wall after it is implanted. The Voyager NC Coronary Dilatation Catheter is available in a wide variety of diameters (from 2 mm to 5 mm) and lengths (from 6 mm to 25 mm) on a rapid exchange delivery system. Proprietary technological advancements that Abbott engineered into the Voyager NC balloon dilatation catheter include: • A specialized tip with a smooth, rounded shape designed to deflect off stent struts and enhance balloon delivery through stents. • Flexible tungsten markers designed to help physicians navigate through arteries and properly position the balloon within a treatment area. • Bi-layer balloon material designed to make the balloon thinner and more flexible, enabling controlled balloon growth. _______________________________

CircuLite® Completes Initial Close on $33 Million Series C Financing Plan and Appoints CMO

Funding to support 2009 European commercial launch of Synergy™ micro-pump for chronic heart failure CircuLite, Inc. announced the closing on $10.5 million in its Series C preferred stock financing. The funds are the initial close on a minimum $33 million financing plan. The Company has secured $23.5 million in insider commitments, with the balance of the round expected from new investors. The financing was led by Forbion Capital Partners and included participation by existing investors Crédit Agricole Private Equity, Foundation Medical Partners and Oxford Bioscience Partners. The Company also announced that Daniel Burkhoff, MD, PhD, Chairman of the Company’s Scientific Advisory Board, has joined the Company’s management team as its Chief Medical Officer. Proceeds from the Series C financing will support completion of the European registration trial for the long-term use of the Synergy™ Pocket Micro-pump for partial circulatory support in patients with Class IIIb and early Class IV heart failure. The Company will also complete the commercial launch of the Synergy device in Europe in 2009, upon CE Mark approval. The Synergy™ Pocket Micro-pump provides a less-invasive, elective treatment option for patients before their disease state becomes irreversible. Synergy is the first implantable system designed to provide partial circulatory support (PCS) for long-term use in millions of unserved patients that have NYHA Class IIIb/early IV disease. CircuLite’s patented micro-pump provides up to 3L/min of flow, which increases total cardiac output and offloads the heart, allowing it to rest and potentially enabling beneficial recovery of heart function. The size of a AA battery, the device is small enough to be implanted subcutaneously in a “pacemaker-like” pocket through a minimally invasive procedure. For more information visit www.CircuLite.net. CAUTION: Investigational Device. Limited by Federal Law to Investigational Use Only. CircuLite® is a registered trademark of CircuLite, Inc. in the United States. Synergy™ is a trademark of CircuLite, Inc. in the United States. _______________________________

STEMI NEWS Goshen General Hospital (Goshen, IN) Reduces DTB Times

Goshen General Hospital is a community hospital serving the 32,000 people of Goshen, IN, that staffs more than 150 physicians across nearly 20 specialties. The hospital is proud of its high standards of care and typically scores in the 90th percentile for Joint Commission accreditation. Each year, the staff provides care to approximately 20 patients suffering acute heart attacks. Challenge In 2006, the staff at Goshen General Hospital began taking a hard look at improving their process for treating heart patients. In particular, they considered technology advancements that could speed the flow of information needed to manage these situations. Goshen’s door-to-inflation time was averaging 129 minutes. One of the reasons it took this long was that contacting all the necessary personnel was a manual process requiring operators to reach some staff members by phone and others by pager. Andrea Daniels, RN, BSN, and Director of Cardiovascular Services at Goshen, knew that the dedicated staff was up to the task of improving care for these patients. “We’re on a mission to provide excellent patient care. If my mom came in as one of our heart attack patients, I wouldn’t want her waiting even 90 minutes before care is administered just because we’re making calls,” she said. Objective Goshen set out to reduce its 129-minute door-to-inflation time to well below the 90-minute guideline and help patients receive treatment faster. The hospital team analyzed their “Code STEMI” (segment elevation myocardial infarction) process. It includes various activities that must occur to transfer critical information quickly among 30 hospital staff members as patients move from registration through the emergency department and ultimately into the surgical suite. The team worked to improve their code STEMI handling through a process that included: • Identifying and evaluating each of the communication and action steps required during a code STEMI. • Evaluating technology and process options to speed or eliminate steps. • Review and trial of the new plan, making all involved clear on their roles. • Refining the process based on real-world situations. _______________________________

Minute-by-Minute Improvement in Processes at Baptist Health (Jacksonville, FL) Leads to Shorter Door-to-Balloon Times

In 2006, Baptist Health’s door-to-balloon times were lower than nationally recommended standards most of the time. But, the staff caring for chest pain and heart attack patients wanted times to be better. And minute by minute, making big and small changes, they were successful. Seeking Chest Pain Center accreditation for all of its adult hospitals, along with better patient outcomes, Baptist Health (Jacksonville, Florida), nurses, physicians and staff began looking at their chest pain protocols to see how they could be improved. Working closely with the regional Emergency Medical System (EMS) and Baptist Health’s own Life Flight air ambulance service was key, of course. But what happened in the cath lab and how fast it happened could mean the difference between life and death. In 2006, Baptist Health created a new position, the cardiac coordinator, staffed by longtime Baptist Health employee Stephanie Thies, RT(R). Her responsibilities included being available 24 hours, seven days a week, to all Baptist Health emergency departments. Now, when a chest pain patient comes in to any Baptist Health emergency department, and an EKG or other assessment indicates a STEMI, she goes into immediate action. “I mobilize the cath lab team at our tertiary hospital, Baptist Medical Center, using a universal beeper,” says Thies, who also pages the cardiologist on call. The universal beeper notifies two cardiac nurses and two cardiovascular technologists (or radiologic technologists) that a chest pain patient is on the way to the cath lab; it also notifies a cardiac critical care unit (CCU) nurse and registration staff. The CCU nurse accesses a “cath lab box” kept in the emergency department that is filled with procedure consent forms, clippers, EKG leads and patches so they can prepare the patient for the cath procedure right away. “The CCU nurse and the Registration representative facilitate movement of the patient through the process to get him or her into the cath lab as early as possible,” explains Debra Stiffler, MSN, RN, CAN, NE, BC, director of the Baptist Heart Hospital. Within 30 minutes, the cardiac cath team is assembled and waiting on the patient, whether he or she comes from Baptist Medical Center’s emergency department; from Baptist Health hospitals in Jacksonville Beach, southern Duval County on Jacksonville’s southside or Nassau County in Fernandina Beach; or from any hospital or Fire/Rescue vehicle regionwide. “In October 2008, patients suspected of having heart disease and needing intervention were receiving a cath procedure under 90 minutes from their arrival in any Baptist Health ER 100% of the time,” says Frank Romanow, RT(R), BS, manager of the Heart Hospital’s cardiac catheterization laboratory. On occasion, numbers are lower due to technical difficulties, more acute patients with multiple serious health conditions, or transportation issues. But overall, numbers have improved, meaning better patient outcomes. “Our patient mortality rate is under two percent, lower than the nationally recommended rate of three percent,” says Romanow. “Because our interventional procedures are done at Baptist Medical Center, we expect those door-to-balloon times to be under 90 minutes,” says cardiologist Marc Litt, MD, the physician champion of the effort. “Of worthy note, though, is that a patient can present at Baptist South, Baptist Beaches or Baptist Nassau and have the same door-to-balloon time as a hospital with a cath lab on-site. That is a real credit to the system.” Another unique aspect of cardiac care at any Baptist Health hospital is the relationship between the ER and Heart Hospital staff with EMS and Life Flight. “We encourage first responders to observe the case if they’d like, and we give them feedback on how the patient is doing,” says Kelly Daniels, MSN, FNP-BC, CCRN, CEN, nurse manager of 3 South at Baptist Heart Hospital. “It is really gratifying to them and to us to see the patient’s condition stabilize.” “The teamwork and dedication of Rescue, Life Flight and the emergency departments of Baptist Health’s community hospitals are amazing,” says Beverly Day, RN, BSN, CCRN, a cardiac nurse at Baptist Heart Hospital. “They ensure we have knowledge about the patient’s condition before they even hit our door. You can’t reach the 90-minute door-to-balloon goal without everybody’s cooperation and work.” In September 2008, due to these efforts, all four adult Baptist Health hospitals received accreditation from the Society for Chest Pain Centers (SCPC). “It was a multi-disciplinary effort between Baptist Health’s two cardiology groups, emergency physicians, nurses, technologists, managers and staff, in cooperation with Rescue, Life Flight and registration staff, to look at our processes in order to see where we could improve,” says Dr. Litt. “It took a lot of work to pinpoint issues and come up with solutions, but we have been able to eliminate a lot of time in our processes and that is saving heart muscle and lives. It’s an ongoing process.” For more information, visit www.e-baptisthealth.com.

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