STEMI Network. Joseph L. Fredi, M.D., FACC. The median D2B time for patients presenting to the Vanderbilt ED was 55 minutes.

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1 STEMI Network STEMI News By Joseph Fredi, M.D., FACC, and Carol R. Scott, B.S.N., M.S.N., coordinators, STEMI Network, Vanderbilt Heart and Vascular Institute Even with the great success our STEMI Network has experienced over the last two years, with each patient transferred through the Vanderbilt STEMI Network, we ask, How can we do it better? and, How can we do it faster? Joseph L. Fredi, M.D., FACC With an eye toward continuous quality improvement, Vanderbilt Heart is pleased to report our door-to-balloon (D2B) results for patients presenting to Vanderbilt ED and the door-door-to balloon (DD2B) results for patients who are transferred in from outlying communities for The median D2B time for patients presenting to the Vanderbilt ED was 55 minutes. The median DD2B time for patients transferred from an outlying facility within a 60-mile radius (zone 1) of Vanderbilt and who participate in the Vanderbilt STEMI Network was 129 minutes. Minutes Carol Scott, B.S.N., M.S.N A B C D E F G H I J K L M N O P Referring facility Hospitals A, B, C, D, E, F, G, J, K, L, M, O, and P are in Zone 1. Hospitals H, I and N are in Zone 2. The median DD2B time for patients transferred from an outlying/community facility within a 120-mile radius (zone 2) of Vanderbilt and who participate in the Network was 164 minutes. Shown is a bar graph reflecting the median DD2B times for 2009 for both zone 1 and 2 referring facilities who participate in the Vanderbilt STEMI Network. The Vanderbilt STEMI Network has existed since We have 16 hospitals in Middle Tennessee and Southern Kentucky that participate in our program. We have seen tremendous improvement during the past two years in reducing the time it takes to transfer a patient from an outlying hospital until the time the affected artery is successfully opened to stop the myocardial infarction. This success can be attributed to the hard work, dedication and perseverance of those medical personnel who are the first responders. We congratulate the EMS and Emergency Department medical and nursing staff! We appreciate and value our relationship with community hospitals, whether they participate in the Network or not. It is communication and cooperation between EMS personnel, Emergency Departments and cardiologists that ensure success in treating patients suffering an acute myocardial infarction. You, your loved ones and the citizens of Middle Tennessee and Southern Kentucky deserve nothing less. Vanderbilt Heart and Vascular Institute Publication Spring 2010 Volume 1 Issue 2 VanderbiltSTEMI.com

2 It s Like Trauma Care For Your Heart By Sheldon Dreaddy, R.N., LifeFlight Nurse Sheldon Dreaddy, R.N. During the past two years, LifeFlight has been fortunate to be a part of some very exciting changes related to heart care in Middle Tennessee. The evolution of Vanderbilt s STEMI Network stressed the need for timely diagnosis and transport to definitive care. Of course, if you want to save time during a patient transport, then utilizing a helicopter makes perfect sense. Transporting acutely ill cardiac patients is nothing new for our flight program, and we have been doing it for more than 25 years. What Joseph Fredi, M.D., and his team wanted to implement with the STEMI Network was a radical change in our approach to the initial patient care. The focus was on time is muscle, and a cardiac cath is the only definitive treatment for this patient population. His team recognized that LifeFlight already provided rapid transport, but they wanted us to be faster. We discussed how Vanderbilt would partner with rural hospitals in Middle Tennessee to encourage immediate and rapid transfers of all STEMI patients. In addition, the implementation of a cardiac transfer center would ensure that LifeFlight was activated within minutes of a transfer request. As a flight crew we adapted the approach we use at an accident scene and tweaked it to make it as effective for STEMI alerts. We essentially focus on rapid assessment, packaging and transport. Twenty five years and thousands of successful trauma transports have proved that this approach is effective and can make the difference in a patient s survival or quality of life. It has taken some practice and a little bit of education to get everyone comfortable with this new approach, but I think we all agree that it has worked well and has proved effective. It is encouraging for us to read cath lab reports, witness the success stories and see patients get a second lease on life. The approach to their care is now aggressive, fast and organized. Vanderbilt is known across the country as a premier Level I Trauma Center, and I have witnessed many miracles in the trauma bays of the E.R. Our cardiac cath rooms are like another set of trauma bays, tucked away just behind the E.R. Cardiac patients are rolled directly into these rooms from the helipad, a handoff report is given, and the procedure is started within minutes. The cath lab team has become a well-oiled machine similar to the one that has existed for trauma patients for years. On a personal note, I was privileged to witness one of their miracles a few weeks ago. A 54-year-old gentleman, who had been in cardiac arrest and had received CPR for more than 20 minutes, needed to be flown to Vanderbilt from a rural E.R. When we arrived at the referring hospital, John McPherson, M.D., contacted me from Vanderbilt and instructed us to initiate the cooling protocol for the patient in order to lower his body temperature and preserve neurologic function. When we arrived at Vanderbilt, we transported him directly to the cath lab, and as a result of the rapid transfer, the cooling and the amazing efforts of the cath lab staff, this gentleman made a full recovery and was discharged home. I have seen some amazing things during my nine years as a flight nurse, but I think this one tops the list. The Vanderbilt STEMI Network and LifeFlight conducted a mock drill for hot-loading patients with Lincoln Medical Center ER staff in Fayetteville, Tenn., in April.

3 Case Study A 76-year-old male began experiencing chest pain at 5 a.m. on Oct. 22, A call was made to 911 at 5:36 a.m., and ProMed EMS transported the patient to Three Rivers Hospital in Waverly, Tenn. The patient reported left neck and arm pain, back pain in between the shoulder blades and diaphoresis. Patient has a history of hypertension and admitted to only taking his medication when his BP is high. Physical Exam: General: awake, alert Respiratory: clear to auscultation bilaterally, no wheezing BP 146/86 P 72 Cardiac: rate regular rhythm, no murmur R 20 T 98.2 Diagnostic Tests: ECG SaO2 94% room air What is your diagnosis? Review this ECG and then visit our website and click on STEMI newsletter to see the answer and to view the catheterization video of this case.

4 Studies Focus on Cardiac Stem Cell Regeneration By David Zhao, M.D., Director of the Cardiac Catheterization Lab and professor of Interventional Cardiology David Zhao, M.D. Nearly 1 million patients suffer a myocardial infarction each year in the United States. Although advances in mechanical and pharmacologic therapies have reduced early and late mortality after acute myocardial injury, a significant proportion of survivors will develop progressive myocardial dysfunction and left ventricular remodeling that lead to congestive cardiac failure and sudden cardiac death. The mechanism behind heart failure is extensive loss of functioning myocardium. Until recently, the heart had been viewed as a terminally differentiated organ without potential for regeneration. Advances in treatment are limited by the inability to repair damaged cardiac tissue. However, this limitation has been challenged by several recent studies that suggest regeneration and preservation of cardiac myocytes by stem cell therapies. These studies were conducted based on the hypothesis that progenitor cells that reside in one s own bone marrow could differentiate to cardiac myocytes and other cardiac cells (such as endothelial cells) that were critical to maintain cardiac function after myocardial infarction. The results of these studies demonstrate a moderate improvement in heart function and a trend toward fewer heart failure symptoms in patients receiving stem cell treatment. Equally important, these preliminary studies demonstrate a safety in bone marrow stem cell therapies as compared to other cell types. We are encouraged by these studies, but the results are far from perfect in part because of the heterogeneity in trial design, type of cell under study, methods for cell preparation and storage, techniques for cell delivery, and timing of cell delivery. To further advance scientific discovery and improve patient outcomes, Vanderbilt University Medical Center, in partnership with the National Institutes of Health (NIH), has been conducting several clinical trials to optimize cardiac stem cell therapies and to understand mechanisms of cardiac stem cell regeneration. Vanderbilt is the only institute in the United States to receive NIH grants in both clinical and basic science research in cardiac stem cell therapy. Currently, there are three clinical trials actively recruiting patients at Vanderbilt. The TIME trial focuses on patients with acute ST elevation myocardial infarction with damaged cardiac function (EF<45%). Patients receive autologous bone marrow cell infusion at day three or day seven after the myocardial infarction. Autologous cells are infused into the patient s coronary artery that supplies the area of infarction. The procedure is similar to a routine coronary stenting with minimal discomfort to the patient. The second trial is LATE TIME that seeks patients with recent MI (>three weeks). The enrollment criteria and procedures are similar to TIME. The third trial is the FOCUS trial that concentrates on patients with chronic ischemia cardiomyopathy. It differs from the TIME and LATE TIME trials in that the FOCUS trial delivers stem cells using a direct endomyocardial injection guided by a magnetic navigation system called NOGA. NOGA allows pinpoint accuracy in delivering cells to the area of ischemia with percutaneous approach. Patients recover rapidly and usually go home the next day. If you, your patients, or family members are interested in these studies, please call (615)

5 Routine and Urgent Transfer Indicated After Full-Dose Fibrinolysis By Eric Thomassee, M.D., Resident, and Robert L. Huang, M.D., M.P.H., Cardiovascular Medicine Fellow Robert Huang, M.D. Eric Thomassee, M.D. Studies have shown the benefit of primary PCI over fibrinolytic therapy in STEMI patients including decreased mortality, reinfarction, and stroke rates. 1,2 Data from the RIKS-HIA registry also showed long-term mortality benefit of primary PCI over fibrinolytic therapy. 2 Additionally, the DANAMI-2 trial demonstrated benefit in outcomes when patients were transferred to a PCI center for primary PCI if transfer times were <120 minutes. 3 If possible, STEMI patients should be treated with primary PCI; however, many present to non-pci centers and sometimes there are unavoidable delays (i.e. weather, transportation issues) causing patients to receive fibrinolytic therapy. Recently, the trial of routine angioplasty and stenting after fibrinolysis to enhance reperfusion in acute myocardial infarction (TRANSFER-AMI) and the Norwegian study on district treatment of ST elevation myocardial infarction (NORDISTEMI) sought to address the question surrounding optimal treatment for STEMI patients who receive full-dose fibrinolytic therapy. The TRANSFER-AMI trial included 1,059 patients who presented to a non- PCI center within three hours of onset of symptoms and received full-dose fibrinolysis with tenecteplase. 4 Patients were randomized to routine urgent transfer for PCI within six hours or transfer if evidence of re-infarction was present (i.e. rescue PCI). If transfer was not completed for rescue PCI indications, patients underwent angiogram after 24 hours. Median needle-to-balloon (N2B) times were 2.8 hours in the routine urgent transfer group vs hours in the standard care group. At 30 days, the primary endpoint (combined incidence of death, reinfarction, recurrent ischemia, new or worsening heart failure or cardiogenic shock) was observed in 11 percent of patients undergoing early transfer vs. 17 percent of patients in the standard treatment group (relative risk 0.64, 95 percent confidence interval , p=0.004). A total of 182 patients (34.9 percent) in the standard group required urgent transfer after fibrinolysis. In the majority of these cases (n=131), urgent transfer was indicated for persistent chest pain and/or ST elevation. 4 No significant differences in the rates of major bleeding or transfusion were seen. The NORDISTEMI trial included 266 patients who presented to a non-pci center. 5 All patients received full-dose tenecteplase if onset of symptoms was < six hours. Randomization groups included immediate transfer for PCI or conservative therapy with an ischemiabased protocol. In the ischemia-based protocol, patients were transferred for PCI if rescue PCI was indicated (persistent chest pain or <50 percent reduction of ST elevations), hemodynamic instability, or recurrent ischemia during exercise stress testing prior to discharge (evident by chest pain, new ST changes, hypotension or ventricular tachycardia). Primary end points (composite death, re-infarction, stroke or new ischemia at 12 months) were observed in 21 percent of patients in the early PCI group vs. 27 percent in the conservative group, p=0.06. The authors excluded new ischemic events from their primary analysis (due to crossover of failed fibrinolysis patients from the conservative arm to the early transfer arm) and found that 6 percent of early transfer patients vs. 16 percent of ischemic-driven patients experienced the composite end point of death, reinfarction, or stroke. PCI was completed in 89 percent of patients in the early transfer group with a median N2B time of 163 minutes. PCI was completed in 71 percent of patients in the ischemia-based protocol with a median N2B time of three days. The two studies increase the evidence for a drip and ship strategy where a STEMI patient who meets fibrinolysis criteria (symptom onset <three hours to presentation, prolonged transport time, and no contraindication for fibrinolysis) would receive full-dose fibrinolytic therapy, be placed on appropriate antiplatelet (aspirin and plavix) and anticoagulant therapy (heparin), and then be shipped to a PCI-capable facility. One interesting point from those studies was that after fibrinolysis, the median time to catheterization and PCI was three hours without excess bleeding. Also, many patients in the conservative arms of the trials crossed over to the early invasive arms highlighting the dynamic nature of STEMI patients and how resolution of ST-segments may not be as definitive as once thought. Current ACC/AHA guidelines recommend urgent transfer of high-risk STEMI patients who receive full-dose (Continued on page 6)

6 VANDERBILT UNIVERSITY Vanderbilt Heart Communications MCE, 5th floor, Ste st Ave. S. Nashville, TN Non-Profit Org. U.S. Postage PAID Nashville, TN Permit No Visit VanderbiltSTEMI.com for more information on Vanderbilt Heart programs Fibrinolysis (Continued from page 5) fibrinolytic therapy from non-pci capable centers to PCI-capable centers where PCI can be performed either when needed or as a pharmacoinvasive strategy. 6 High-risk patients include those with systolic blood pressure <100 mmhg, heart rate >100, Killip Class II-III, 2mm ST-depression in anterior leads, or 1mm ST elevation in V4 indicative of RV involvement. The guidelines also do not advocate using half-dose lytic therapy (i.e. facilitated PCI) with immediate PCI due to increased bleeding and adverse outcomes based off the ASSENT-4 trial. 7 In conclusion, primary PCI continues to be standard of care in STEMI patients who present to PCI centers and in those that can timely transport patients through a primary PCI network; however, if fibrinolytic therapy must be given, those patients should also be transferred to a PCIcapable center. The VUMC STEMI Network strives to facilitate evidencebased practices and transport of STEMI patients for primary PCI, rescue PCI (PCI after failed fibrinolysis), and routine urgent angiography following successful fibrinolysis. 1. Keeley EC, Boura JA, Grines CL. Comparison of primary and facilitated percutaneous coronary interventions for STelevation myocardial infarction: quantitative review of randomized trials. Lancet 2006; 367: Stenestrand U, Lindback, J, et al. Long-term Outcome of Primary Percutaneous Coronary Intervention vs Prehospital and In-Hospital Thrombolysis for Patients With ST-Elevation Myocardial Infarction. JAMA 2006; 296: Busk M, Maeng M, Rasmussen K, et al. The Danish multicentre randomized study of fibrinolysis therapy vs. primary angioplasty in acute myocardial infarction (the DANAMI-2 trial): outcome after 3 years followup. Eur Heart J 2008; 29: Cantor WJ, Fitchett D, Borgundvaag B, et al. Routine early angioplasty after fibrinolysis for acute myocardial infarction. N Engl J Med 2009; 360: Bohmer E, Hoffmann P, et al. Efficacy and safety of immediate angioplasty versus ischemicguided management after thrombolysis in acute myocardial infarction in areas with very long transfer distances. J Am Coll Cardiol 2010; 55: Kushner FG, Hand M, et al Focused Update on Management of Patients with STEMI. J Am Coll Cardiol 2009; 54: Primary versus tenecteplase-facilitated percutaneous coronary intervention in patients with ST-segment elevation acute myocardial infarction (ASSENT-4 trial): randomized trial. Lancet 2006; 367:569. Thank you to our partner: