STEMI Recommendations by Leading Physicians at LUMEN 2009

LUMEN, a meeting focusing on both the “process and procedure” of ST-elevation myocardial infarction and chaired by SINCERE database operator Dr. Sameer Mehta, took place February 26-28, 2009 in Miami, Florida. If done within 90 minutes of presentation, primary percutaneous coronary intervention (PPCI) remains the first choice to save the lives of ST-elevation myocardial infarction (STEMI) patients, but the United States remains behind much of the western world in timely access to this procedure, concluded presenters at LUMEN 2009. Healthcare providers must coordinate efforts to overcome what are often steep obstacles in the path of these vulnerable patients: geographical limitations, education, legislation, and system and transfer delays. LUMEN, gathering together those on the cutting-edge of STEMI management, disseminated the latest insights and research from those on the front lines of STEMI care, from emergency medical services (EMS) to the emergency department (ED) to the cardiac catheterization laboratory (CCL). LUMEN’s Four Keynote Addresses Representing the American College of Cardiology (ACC), President W. Douglas Weaver, MD, took a look at the grim state of the U.S. economy, noting that 500,000 people are losing their job each month. Meanwhile, 15% of the national budget is taken up by healthcare costs. The U.S. has the most expensive healthcare system in the world, Dr. Weaver said, but the value received does not measure up to the high cost, and healthcare reform and payment reform are a given under the new administration. Dr. Weaver emphasized that the ACC message has always been to support additional payment for quality. Regarding STEMI care, he looked at the question of whether it is best to emergently transfer all patients for PCI without pharmacologic therapy. The answer is no, if there will be a two-plus hour delay. Thrombolysis, Dr. Weaver reminded attendees, is a good option if time to transfer is longer than the 90-minute window, and he cited data from recent transfer trials like CARESS and TRANSFER-AMI. Hospitals without PPCI capability that have patients with transfer times pushing two hours also need to have an overall strategy of how to handle these patients, not go case-by-case. However, Dr. Weaver said, the necessary evidence on how best to treat patients in these situations does not yet exist. Research is needed that will look at a transfer for PCI (minus pharmacotherapy) versus a pharmacoinvasive strategy. Dr. Weaver went on to share the success of the D2B Alliance (www.d2balliance.org), a Guidelines Applied in Practice (GAP) program launched by the ACC to reduce door-to-balloon times. When it first began, less than half of the participant hospitals met the 90-minute window. Today, that number has grown to 82%. A former president of the American Heart Association (AHA) and chairperson of the “Mission Lifeline” initiative, Alice Jacobs, MD, FACC, took a close look at the problems in increasing the number of patients with timely access to PPCI. She cited 2007 data showing 1731 cath labs in the U.S., with only 1331 PCI-capable. In rural areas of the U.S., only 4% of hospitals have the ability to perform PPCI, meaning a prolonged transfer time. In addition, of all STEMI transfer patients, only 8.6% are reperfused in less than 90 minutes. Dr. Jacobs listed other roadblocks to improving regional STEMI care as: • Less than 50% of patients use EMS. • The majority of EMS systems do not use 12-lead ECG. • Heart disease is not evenly distributed by population density. • Hospital EDs are frequently on diversion. • Financial disincentives exist for patient transfer for PCI • Current transfer times in the US are unacceptable In response to these challenges, the AHA has launched “Mission Lifeline,” a broad-based initiative that addresses the continuum of STEMI care, from the patient’s entry into the system, throughout the system of hospitals, and back to the local community and primary care provider. While a national effort, it is “a community-based initiative that considers the existing geography, resources, legislation, and regulations in each community,” noted Dr. Jacobs. The initial implementation plan for Mission: Lifeline consists of: 1) Assess and improve EMS; 2) Evaluate existing models of STEMI care; 3) Establish local initiatives; 4) Offer national STEMI certification criteria. AHA staff across the country has been trained to implement Mission Lifeline. Dr. Jacobs encouraged everyone to visit Mission Lifeline online at www.americanheart.org/missionlifeline. She asked that you register your STEMI system and emphasized the value of the “Mission: Lifeline Summary Table,” an easy-to-use reference tool available on the website. William O’Neill, MD, FACC, a pioneer in STEMI interventions, looked at mortality for acute MI, noting that prior to 1985, it was at 13% and in 2000, it stood at 1.8%. He believes we will move to a STEMI mortality rate consistently under 1%. Dr. O’Neill also addressed the recent backlash against angioplasty by sharing the story of President Dwight D. Eisenhower’s acute MI in 1955. The course of Eisenhower’s treatment involved three months in the hospital and a morphine drip. Physicians could only hope he would survive. Dr. O’Neill emphasized, “The way we conquered this disease is one of the true miracles of the 20th century… Don’t be bashful about the wonderful care we are providing patients.” He also pointed out that even early pioneers could get it wrong — Andreas Gruentzig was actually opposed to angioplasty in acute MI; in the 1970’s, there was an enormous amount of controversy in the pathology literature as to whether thrombus mattered or not; and it wasn’t until 1981 that left ventricular function was first demonstrated to impact patient prognosis. In regard to current STEMI care, he commented, “At the end of the day, if you don’t improve mortality, you’re not going to make very much headway… We need to start talking about symptom onset to reperfusion time.” Martin B. Leon, MD, FACC, Chairman Emeritus of the Cardiovascular Research Foundation and Professor of Medicine at Columbia University Medical Center, as well as director and founder of the annual Transcatheter Cardiovascular Therapeutics (TCT) meeting, discussed the current state of coronary interventions. He argued that medicine is the “art of balance” between evidence-based medicine and three important additional factors: the physician’s clinical judgment, patient and physician expectations, and socioeconomic factors. Despite the emphasis on evidence-based medicine, these factors must also be taken into account in patient treatment. Dr. Leon addressed mainstream media reactions to clinical trial data, noting, “Taking a single clinical trial and coming up with a global sound bite has hurt us.” Yet he also took a critical look at randomized clinical trials, commenting, “The word ‘randomized’ doesn’t sanctify a study,” and noting that the trend toward meta-analyses is not helpful either, as “35% of meta-analyses are frankly wrong.” Meta-analyses, he said, are no substitute for a single, adequately powered randomized clinical trial involving anywhere between 10,000-100,000 patients. According to Dr. Leon, the current environment threatens to stifle innovation in the U.S. Regulatory hurdles are extraordinary and costs to develop a device run anywhere from $150-250 million. Despite these challenges, what innovations can be expected? Currently, we are seeing the development of percutaneous treatment of structural heart disease. Dr. Leon expects future treatments will address myocardial disease (congestive heart failure), valvular heart disease, vulnerable plaque, left atrial appendage (LAA) closure (atrial fibrillation), arrhythmias and systemic hypertension. He emphasized that in procedures like transcatheter aortic valve replacement (AVR), multi-disciplinary collaboration between interventionalists and surgeons will be essential and take place on a daily basis. Finally, Dr. Leon shared what he sees as the pathway typically taken by the interventional community when a new device or procedure is introduced: 1) Unbridled enthusiasm; 2) Rapid adoption; 3) Untoward complications; 4) A “second wave” effect, leading to realistic adoption of the technology or procedure. World’s Best Programs Presented An exciting highlight of the meeting was the STEMI Processes Symposium. Five of the world’s best population-based, regional STEMI systems of care were presented by key opinion leaders in PPCI. Presenters specifically addressed the challenges that their program met and the steps they respectively took to achieve success and system-wide door-to-balloon time improvements. LUMEN chair Dr. Sameer Mehta succinctly reviewed the take-home messages from each of these presentations: 1. The Mayo Clinic (Charanjit Rihal, MD, BSc [Med], MBA) in Minneapolis, MN: Very early reperfusion is critical and every effort must be made to provide system-wide, early reperfusion. 2. The RACE program (James Hoekstra, MD) in the state of North Carolina (www.race-er.org): Keep it simple and provide feedback to the stakeholders (the people in the trenches). 3. Citywide Protocol for Ottawa, Canada (Michel Le May, MD, FRCPC): Advanced care paramedics and IT penetration enhance early STEMI activation and management. 4. Minneapolis Heart Institute at Abbott Northwestern Hospital (Timothy Henry, MD): STEMI protocols and system improvements can be successfully expanded to improved outcomes with cooling/ induced hypothermia and for patients with cardiogenic shock, aortic dissection and ACS. 5. SOCAL: Southern California Systems (Ivan Rokos, MD, FACEP): System-wide, early activation is essential for achieving regional door-to-balloon improvements; destination protocols and clear communications between referring and PCI facility are essential. In a statement echoed by many presenters, Dr. Le May noted, “Standardization is key to running a primary PCI program.” Dr. Le May also cited a study showing that $2,459/patient could be saved over 6 months with the use of PPCI over thrombolytics (Circulation 2003). Hot Topics Debated Additional highlights of LUMEN included “The Great Debates,” an (often spirited) discussion of two topics: 1. Which stent should be used in primary PCI? Dr. Rihal of the Mayo Clinic argued for drug-eluting stents and Dr. Renu Virmani argued for bare-metal stents. While Dr. Rihal pointed out that Dr. Virmani’s argument for BMS is limited by her work as a pathologist (i.e. her patients are all deceased), Dr. Virmani shared slides of lesions that remained unhealed months after a DES was placed. 2. Where to perform primary PCI? Dr. Le May argued for high-volume tertiary centers and cited better outcomes at these facilities, as compared to low-volume centers. Dr. Alice Jacobs argued for more centers performing PPCI without surgical back up and suggested it as a possible way to achieve improved door-to-balloon times at more institutions. However, she cautioned about having proper transfer protocols at these institutions and about the importance of monitoring outcomes data. Workshops LUMEN workshops offered attendees the chance to break out into various areas of interest and take a more focused look at various critical STEMI topics: • STEMI EKG Certification Course: Chairperson, Simon Chakko, MD This was the first-ever STEMI EKG Certification Course. Attendees underwent a rigorous curriculum providing tips to augment the accuracy of EKG in diagnosing STEMI. • STEMI Teamwork: Learning from Simulation: Chairperson, William Hamman, MD; Miami-Dade EMS Teams & Mentice, Inc. In vitro stimulation of the door-to-balloon process was demonstrated with participation by the EMS, ED and CCL teams. Through this simulative exercise, there was a vivid illustration of patient safety, teamwork and process efficiency of the door-to-balloon process. • STEMI Interventions Cine Review: Chairperson, Sameer Mehta, MD The critical importance of identifying the culprit lesion, compulsive management of thrombus, performing complex STEMI interventions and managing cardiogenic shock: these and various important procedural skills were taught in this workshop. Various tips and tricks of performing short door-to-balloon time STEMI interventions were reviewed in detail. • STEMI Critical Nursing Issues: Chairperson, Barbara Unger, RN Nursing skills unique to door-to-balloon time interventions were reviewed by a world-expert in critical care nursing and an experienced panel of ED, CCL and CCU nurses. Effective triage, staffing, special nursing issues and trouble-shooting were highlights of this very popular workshop. • Adjuncts to STEMI Interventions: Chairperson, Samin Sharma, MD Various aspiration and mechanical thrombectomy devices, intracoronary drug delivery, left ventricular assist devices and emerging modalities were discussed by an experienced panel of interventional cardiologists who provided their tips and tricks to perform complex STEMI interventions. • CEO Summit: Lessons for Administrators/Chairperson, Monica Manasa, MD In this unique workshop, an expert panel of ED and EMS physicians, interventional cardiologists, administrators and an experienced healthcare attorney discussed important systems, financial and legal issues pertaining to STEMI interventions. • Cooling/Hypothermia Devices: Chairperson, Michael Mooney, MD Numerous induced hypothermia protocols for the cardiac arrest STEMI survivor were discussed by an expert panel and the important work from Abbott Northwestern Hospital in this area was reviewed. • Demonstration of Pre-Hospital EKG Systems: Chairperson, James Hoekstra, MD In this robust workshop, world experts from the ED and EMS reviewed the critical importance of early STEMI activations systems. Technological innovations in the field were demonstration by representatives from Philips Healthcare, Medtronic/Physio-Control and Zoll. • Tips for Setting up a Transfer Network: Chairperson, Ivan Rokos, MD The importance of seamless transfer of a STEMI patient from a non-PCI facility, destination protocols, ACC/ AHA guidelines, transfer agreements and other issues related to setting up of transfer networks were reviewed in this workshop. EMS The EMS perspective was provided by J. Brent Myers, MD, MPH, FACEP, who presented some of the questions that EMS is grappling with in STEMI care: • Who activates the cath lab? Dr. Myers noted that paramedic activation dropped mortality by 6-8% in every trial measuring this aspect. STEMI positive predictive value for paramedics is approximately 90%, but can be as high as 99%. • What is the acceptable false positive rate? Dr. Myers cited 10 or 15% as a generally acceptable false positive rate; however, he noted that trauma care has accepted a 30-50% over-triage rate, due to the strength of evidence for trauma care. • How far is “too far” to divert for PCI? There is no available evidence to answer this question, but Dr. Myers offered a guideline of 90 minutes or 90 miles. • How much of STEMI care should be accomplished in the pre-hospital setting? Dr. Myers recommended ASA if the patient is not allergic, a 12-lead EKG with preactivation of the cardiac cath lab if indicated, and direct transport to a PCI center. Should EMS administer a half dose of lytics? This question remains unanswered. From a simple economic perspective, he noted that EMS is socialized medicine. Providers are paid a flat fee regardless of interventions. In light of this fact, can EMS afford to increase its interventions? The practical option, Dr. Myers concluded, is that EMS activate the cardiac cath lab with obvious STEMIs and transmit borderline cases (left bundle branch block, left ventricular hypertrophy, etc.) for consultation. He noted that this is similar to many EMS/hospital approaches to trauma care. New Technology in ECG James Hoekstra, MD, past president of the American Society for Academic Emergency Medicine, presented information on the Prime ECG, an 80-lead ECG body surface map. The Prime ECG was created to map areas of the heart that are “silent” on a traditional 12-lead ECG (posterior MIs, right-side MIs, etc.). As an example of the need for this type of technology, Dr. Hoekstra pointed out that in the TRITON trial subset analysis, 95% of occult STEMIs were missed. Prime ECG has 64 anterior and 16 posterior leads. The conventional 1-6 V leads are marked. It is possible to investigate data from all leads. An interactive algorithm suggests a diagnosis, showing a model of a chest where red = ST elevation, blue = ST depression, and green = no deflection. Three trials have shown that the Prime ECG detected acute MI 23-35% better than a 12-lead ECG. The trial results suggested that an 80-lead ECG could be used after a 12-lead in patients with ongoing symptoms but where the 12-lead does not show a STEMI. Dr. Mehta, commenting on the results, indicated that this type of technology would also be particularly useful in the ED when patients present with ongoing chest pain, but a typical 12-lead ECG is inconclusive. Thrombolytics Dean Kereiakes, MD, FACC presented on the pharmacological management of STEMI interventions. He noted that patients with high platelet activity have higher rates of major adverse cardiac events (MACE), impaired microvascular perfusion and may have reduced responsiveness to antiplatelet therapy. Dr. Kereiakes said bivalrudin monotherapy provides inadequate potent platelet inhibition in STEMI, recommending bivalirudin, intracoronary abciximab and a 600mg load of oral clopidogrel as the optimal adjunctive pharmacotherapy for PPCI. Promising new drugs on the horizon include cangrelor (investigational) and prasugrel (awaiting FDA approval) which are both platelet P2Y12 receptor inhibitors. Michael Mooney, MD, discussed the role of thrombolytic therapy. Primary PCI is superior to fibrinolysis, Dr. Mooney concurred, but with two big “ifs”: 1. PCI is at a high-volume center. 2. PCI takes place within the 90-minute window. Immediate PCI post lysis remains better than lysis plus or minus delayed PCI, he said. With delays greater than 120 minutes, Dr. Mooney noted that facilitated PCI may be preferable, with up to two-thirds of patients expected to have long transfer delays. Cindy Grines, MD, FACC, offered some take-home lessons from STEMI clinical trials. She made 6 key points: 1) PPCI is superior to thrombolytic therapy, and all STEMI patients should have access to 24/7 PCI (and not just given thrombolytic therapy on weekends or nights); 2) Do not automatically give lytics if the anticipated door-to-balloon time is greater than 90 minutes. European centers are saying 120 minutes is the limit, but we don’t have evidence either way; 3) Do not facilitate reperfusion by giving lytics up front. It increases bleeding, reinfarction and mortality; 4) Be careful using bivalirudin unless the patient has been pretreated several hours beforehand with high-dose clopidogrel; 5) Perform thrombectomy in vessels with angiographic evidence of large thrombus; 6) Drug-eluting stents during PPCI are safe within the first year, reducing target vessel revascularization. Patient ability to adhere to a clopidogrel regimen should be taken into consideration, however. Additional LUMEN highlights included Dr. Renu Virmani, looking at the pathology of the STEMI lesion and the role of thrombus; Dr. Brahmajee Nallamothu’s discussion of door-to-balloon times and their clinical relevance; a look at STEMI teams and simulation exercises by Dr. William Hamman (for more information, see the CLD February 2009 interview with Dr. Hamman); Dr. Rajesh Dave’s look at intracoronary drug delivery (Dr. Dave published a 5-case series in CLD from September 2009 through February 2009); Dr. Samin Sharma’s technical pearls on complex coronary interventions; and Dr. Sameer Mehta’s review of the SINCERE (Single Individual Community Experience Registry for Primary PCI) database, now up to 390 patients, and the ten commandments of STEMI interventions. The Medicines Company sponsored a breakfast meeting on the relevance of antithrombotic treatment in STEMI interventions. TherOx, Inc., held an evening symposium on supersaturated oxygen therapy (look for more information on this novel therapeutic approach in an upcoming issue of CLD). Over 165 attendees were at LUMEN 2009. Attendees received copies of Dr. Sameer Mehta’s Textbook of STEMI Interventions free in their bags, courtesy of The Medicines Company. A big thank you to all LUMEN exhibitors: Abiomed, Angel Medical Systems, Atrium Medical Corporation, Datascope Corporation, Guerbet, LLC, Heartscape Technology, Inc., Medivance, Medrad Interventional/ Possis, Medtronic, Inc., Mentice, Inc., Philips Healthcare, Physio-Control, TherOx, Inc., and The Medicines Company. Visit LUMEN online at www. LumenAMI.com Save the date: LUMEN 2010 is slated for February 25-27 in Miami, Florida.

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