Primary Angioplasty at Community Hospitals in the 21st Century Now The Treatment of Choice for Myocardial Infarction at Q

PLEASE CLICK ON IMAGE FOR LARGER VERSION He was started on fluids and pressors which did not help his shock. His hematocrit was 28% and he was typed and cross-matched for 4 units. His distraught wife thought he was going to die. John was 81 years old. John™s wife heard the ED physician, ED team and the interventional cardiologist explain the treatment options. They strongly advised her that emergency intra-aortic balloon pump [IABP] placement and cardiac catheterization with coronary angioplasty offered John the best, and perhaps the only, chance for survival. Though everything seemed hopeless, she agreed. John was taken directly to the cardiac cath lab (CCL) at 3 am. An IABP was placed and a critical narrowing with a large clot was found occluding a large right coronary artery, with slow (TIMI Grade 2) flow into the distal vessel (Figure 1.). There was a 60% narrowing of the left main coronary as well. What were the options for reperfusion treatment for John? What about thrombolytics? What about transfer by ambulance to the cardiac surgery center 45 minutes away for primary angioplasty? John clearly represents a very high-risk case, in view of his cardiogenic shock, advanced age, and active GI bleeding. Thrombolytics are certainly contraindicated, yet without a reperfusion option, it seemed certain that John would die. He was too unstable to survive a 45-minute ambulance trip. How should his heart attack be treated? This community hospital, which does not have cardiac surgery on site, is one of over 60 such hospitals in the U.S. which offers primary angioplasty as first-line standard of care for patients with acute MI. Is it acceptable or reasonable to offer John primary PTCA if the hospital doesn™t have bypass surgery on site? Primary Angioplasty Is the Treatment of Choice in Acute Myocardial Infarction Primary percutaneous transluminal coronary angioplasty (PTCA) (including coronary stenting) is now the treatment of choice for patients with acute myocardial infarction (AMI) at qualified hospitals (Table 1, Figure 2).1-3 Primary PTCA lowers the rates of death, stroke, recurrent ischemia and reinfarction compared to thrombolytic therapy.1 In the current era of newer-generation stents and glycoprotein (GP) IIb/IIIa platelet inhibitors, the advantage of primary PTCA over thrombolytic therapy is even more dramatic.4 In addition, the early angiogram alone provides valuable information for a more accurate diagnosis and thus better triage to the most appropriate therapy which may be bypass surgery if there is critical left main or 3-vessel disease with open vessels.5 Further, in low-risk AMI patients, primary PTCA has a very low mortality (0.4%), and decreases hospital costs due to safe early discharge (3-4 days) and avoidance of intensive care and pre-discharge exercise testing (Table 2).5,6 More importantly, two-thirds of patients with acute MI are not candidates for thrombolytic therapy7,8: patients without ST elevation but with unrelieved ischemic symptoms (a higher-risk group), patients who present late, patients with bleeding contraindications (such as the case described herein), patients with cardiogenic shock, those with prior bypass surgery9, and the elderly (Table 3). A recent report of outcomes of Medicare patients demonstrated that thrombolytic therapy in patients >75 years old, especially in women, resulted in worse outcomes compared to no reperfusion therapy.10 This elderly population represents almost one-third of all AMI patients.11 These groups of patients that are ineligible for thrombolytics are at higher risk of death than those eligible7,12,13, and need a treatment alternative to morphine and bed rest. Patients in whom thrombolytic therapy is inappropriate due to bleeding risk, non-diagnostic electrocardiogram (EKG), left bundle branch block, or late presentation have considerably improved outcomes when treated with primary PTCA rather than with conventional or thrombolytic therapy (Table 4).14-16 Most patients with AMI present to community hospitals that do not have cardiac surgery programs. At these hospitals, high-risk thrombolytic-ineligible patients, or to those in whom thrombolytic therapy fails, are often transferred to an interventional center. However, patients transferred for primary PTCA have much longer times-to-reperfusion and mortality rates compared to those having primary PTCA at the presenting hospital (Table 5).17 A further problem with this approach is that many surgical centers do not themselves offer primary PTCA routinely, and thus may hesitate to accept such patients in emergency transfer. How Can the Availability of Primary PTCA Be Extended? From the above, it is clear that there is a need to increase the availability of primary PTCA. There is also a great opportunity to accomplish this, since over 850 community hospitals in the US have cardiac catheterization laboratories without on-site cardiac surgical programs. It is not unusual for these diagnostic catheterization laboratories to be staffed by experienced interventionalists who routinely perform PTCA and stenting at surgical centers. More and more hospitals in the U.S. with cath labs but without cardiac surgery are starting to perform primary PTCA routinely as the treatment of choice for acute MI. Some of these hospitals have been performing primary PTCA for many years. A few also offer elective PTCA. Figure 3 shows 60 hospitals in the US and one in New Zealand known to offer primary and/or elective PTCA; hospitals participating in the Primary Angioplasty with No Surgery On Site (PAMINo S.O.S!) Registry are also indicated (see next section below). A great many other hospitals in Europe and Canada also perform PTCA without cardiac surgery. (We would appreciate hearing from any other hospitals that offer PTCA without on-site surgery; we hope to start a national registry of PTCA at such hospitals in the near future.) Studies (described below) indicate that the lack of in-house cardiac surgery does not worsen their outcomes.18-28 The success of these programs depends on having experienced interventionalists, an experienced staff, optimal interventional and imaging equipment, and formal arrangements for expeditious transfer to a surgical center.26 Hospitals which establish primary PTCA programs with or without on-site cardiac surgery should perform the procedure fairly exclusively as routine first-line care for all patients presenting with AMI. This should maximize institutional and operator volumes, streamline critical care pathways, improve door-to-balloon times, and thus optimize outcomes. A higher institutional volume of primary PTCA correlates with improved mortality rates29: in the Second National Registry of Myocardial Infarction (NRMI-2), the mortality of patients with AMI that received primary PTCA was 33% lower at institutions which performed over 36 primary PTCA procedures per year than at institutions that performed less than 12 of these procedures per year.30-31 Almost all community hospitals that offer primary PTCA as first-line therapy perform well over 36 such procedures annually. What is the Evidence that Primary Angioplasty Can Be Performed Safely and Effectively at Sites Without Cardiac Surgery? Several registries of primary PTCA at sites without cardiac surgery have been published. In our Exeter and Portsmouth Hospitals primary PTCA experience, published last year26, three experienced operators performed coronary angiography with primary PTCA when appropriate in 506 patients with acute MI, using the standards and criteria that are reproduced in Tables 6 and 7. Most cases were performed in the era prior to coronary stents and GP IIb/IIIa inhibitors; only totally occluded arteries were dilated then. In this series, over two-thirds of our patients had clinical high risk predictors (Killip Class 3 or 4, age >= 75 years, anterior AMI, out-of-hospital ventricular fibrillation) and/or angiographic high risk predictors (left main or three vessel disease or ejection fraction <45%) (Figure 4). Our median time from door to first angiogram was 94 minutes (Figure 5); we achieved brisk (TIMI Grade 3) flow and <50% residual in 94% of PTCA procedures. Our overall mortality was 5.3%. In 56 patients who presented in shock, the mortality was 23%; in patients without shock, mortality was 3.0%. No patients died or needed emergency bypass surgery because of new myocardial jeopardy caused by a complication of the cardiac catheterization or PTCA procedure. Moreover, the excellent low mortality rate in patients having primary PTCA was sustained at six months after discharge. Our outcomes compared quite favorably to those achieved in the Primary Angioplasty Registry of 245 patients without shock at six experienced high-volume surgical centers (Figure 6).32 The Primary Angioplasty in Myocardial Infarction with No Surgery On Site [PAMI “ No S.O.S.!] study, which recently completed enrollment, evaluated the outcomes of primary PTCA in patients with high-risk acute myocardial infarction that present to hospitals without cardiac surgery. Nineteen hospitals enrolled 500 high-risk patients with acute MI: chest pain >30 minutes and <12 hours with ST-segment elevation. In addition, patients had to have at least one of the following high risk predictors present: age > 70; heart rate >100, systolic BP < 100, Killip class 2-3 (rales or pulmonary edema), left bundle branch block or anterior myocardial infarction. Patients with cardiogenic shock underwent PTCA but were not included in this registry, to allow comparison to other ongoing PAMI trials. The most recent results of the PAMI-No S.O.S.! Registry were presented at the ACC Scientific Sessions in March 1999.27 Primary intervention was successful in 97% of patients, 60% of whom had stents. The median time from ER arrival to first angiogram was 81 minutes. The in-hospital mortality rate was only 2.8%; disabling stroke occurred in 0.4%; no patient suffered reinfarction. Six percent of patients were transferred for emergency bypass surgery, for reasons discovered by the angiogram (critical proximal coronary artery narrowings); these patients usually had the clotted arteries dilated before transfer. Only one was transferred because of cath lab mishap (pericardial tamponade) and no patients died or suffered a new MI because of the procedure. All transferred patients survived. The mean length of hospitalization for this elderly, high-risk population, including 50 patients referred for bypass surgery before discharge, was only 5.2 days. These results compared very favorably to the outcomes of similar high-risk patients in the PAMI-2 and STENT PAMI trials at surgical hospitals. Table 8 summarizes the combined experience of these two studies and the four other published registries of primary PTCA without on-site cardiac surgery.19,22-28 In a total of 1,678 primary PTCA procedures, the overall mortality was 6.0%. Data on patients with and without shock are available on 1,208 patients in these series: the mortality in the 1101 of these patients that did not have cardiogenic shock was 3.0%. Only 2 patients (0.17%) out of 1,418 patients in which data are available required emergency bypass surgery because of new myocardial jeopardy caused by the PTCA procedure. These registries at hospitals without on-site cardiac surgery demonstrate that primary PTCA can be provided safely and effectively at such hospitals in a high risk population, with outstandingly good outcomes which are similar to those reported from high-volume surgical centers. In addition, there are several large registries of non-emergency PTCA at hospitals without on-site cardiac surgery outside the U.S. One registry in France of over 50,000 PTCA patients recently reported no differences in the outcomes of centers with and without cardiac surgery, with less than 0.4% of patients requiring emergency surgery: 0.44% of patients at surgical hospitals and 0.25% of patients at non-surgical hospitals were sent for emergency bypass.33 Two-thirds of the hospitals in this registry did not have on-site surgical facilities. The mortality at the surgical hospitals was 0.7%; at non-surgical hospitals it was 0.4%. Seven other registries of elective PTCA without on-site surgery, from Canada, the United Kingdom, Germany, and Italy, report outcomes of an aggregate of over 70,000 patients undergoing non-emergent PTCA at hospitals without in-house surgery.34-43 The overall mortality, pooling data from all of these series, was 0.48%. So outside of the U.S., the world™s literature reports outstanding outcomes in 120,000 patients receiving elective PTCA in hospitals without bypass surgery. These centers also routinely treat AMI with primary PTCA. We will be presenting to the AHA Scientific Sessions this November an abstract pooling the outcomes of patients undergoing non-emergent intervention at 7 U.S. hospitals without cardiac surgery on site. This is the first such experience reported in this country. The mean annual institutional angioplasty volume was 185 (range 101 to 287). Two pts (0.1%) were transferred emergently to a surgical center because of a procedural complication. In this population, in which 49% had unstable angina, the in-hospital mortality was 0.1%. What Are Some of the Political Barriers to Extending Primary PTCA to Hospitals Without On-Site Cardiac Surgery? Despite this growing body of evidence that supports the safety and feasibility of primary PTCA at hospitals without on-site cardiac surgery, many states still have regulations which prohibit the performance of all PTCA at all hospitals which do not have cardiac surgery programs. Many strict statutes were established decades ago, when the risk of elective PTCA causing a surgical emergency (abrupt vessel closure) was around 5%. Such statutes were written before the advent of primary PTCA for totally occluded arteries in patients with AMI, and well before the advent of stents and glycoprotein IIb/IIIa platelet inhibitors, which have decreased the risk of surgical emergency to about 0.4% and have improved outcomes quite substantially.33,44-49 Thus interventionalists are often prohibited from administering potentially life-saving therapy solely because open-heart surgery back-up is not physically on-site. Open-heart surgery may not even be a consideration in some of the more critically ill patients with AMI. It is difficult to identify any other circumstances in the medical profession where a qualified physician can be prevented by statute from doing what is necessary in an emergency to save the life of a critically ill patient when other therapies fail or would be futile. Cardiologists are mounting efforts in several states to change such rigid regulations. Many of these states hesitate to allow primary PTCA as a result of their interpretation of the ACC/AHA guidelines for the management of AMI.50 Yet these guidelines do not take the extreme position that has been taken by some states. These guidelines advise that ¦primary PTCA should be performed in centers with cardiac surgical capability or in those institutions with a proven plan for rapid access to cardiac surgery in a nearby facility. Specifically, the guidelines approve primary PTCA when performed at high-volume surgical hospitals by high-volume operators (a Class I indication), and contraindicate primary PTCA when performed at non-surgical hospitals by low volume operators in thrombolytic-eligible patients (Class III). But they do not address the vast middle ground that lies between these two extremes. We would urge that future revisions of these guidelines more specifically address this middle ground, which includes primary PTCA at non-surgical hospitals: (a) by high-volume operators, or (b) in patients with cardiogenic shock (otherwise a Class I indication for primary PTCA), or (c) in patients who are ineligible for thrombolysis, or (d) in the elderly10,11,51, or (e) in patients in whom thrombolytic therapy has failed. The British Cardiac Society and British Cardiovascular Intervention Society together recently issued new guidelines for coronary angioplasty in the U.K.52 These guidelines now allow both emergent and elective PTCA to be performed at hospitals without on-site cardiac surgery, provided that they otherwise meet standards of care and have systems in place to enable patients to be on cardiopulmonary bypass within 90 minutes of calling the cardiac surgeon. In addition, regulations in the Netherlands and in Australia have recently been expanded to allow PTCA programs at hospitals without cardiac surgery. What are the Institutional, Physician, Nursing and Cath Lab Requirements for Starting a Primary PTCA Program at a Hospital Without On-Site Cardiac Surgery? Starting a primary PTCA program is a labor-intensive process. It requires the collaboration and dedication of all health care team members and the hospital administration. Requirements for credentialing of interventional staff must be developed. New expectations, procedures and educational programs need to be implemented. Paramedics and Emergency Department [ED] physicians have to develop protocols for medication administration and ECG transmission prior to ED arrival. ED and cath lab staff must learn to triage the acute MI patient quickly, to minimize the door-to-balloon time between patient arrival and opening the artery. Primary PTCA must be offered as routine, first-line care for patients with AMI. The cath team must be on call 24 hours a day, 7 days a week.53 A standardized critical care map with a 24/7 call schedule will streamline care paths, shorten door-to-balloon times, increase volumes, and enhance outcomes.29-31 Critical Care RN™s and ED RN™s may need to provide additional nursing coverage and assist in managing acutely ill unstable patients. This cross-coverage helps assure that outcomes on procedures done off-hours will equal those done during the day.54,55 Critical Care nurses must be proficient with femoral sheaths, pulmonary lines, temporary pacers and/or intra-aortic balloons. The potential for groin bleeding will require development of standing orders and protocols for quick detection and control, and education in the use of femoral balloon compression devices. ED staff, cath lab staff and RN™s must be given professional and educational opportunities to maintain their skills at the highest level. Procedures and institutional agreements with a surgical center must be in place for the expeditious transfer of patients with life-threatening lesions. Finally, cardiac rehab staff will be compelled to originate fast-track education programs to reach low risk patients, who are often discharged after only two to three days in the hospital and thus may minimize the importance of their MI. Conclusions Immediate coronary angiography with primary PTCA in acute myocardial infarction can be safe and effective at qualified community hospitals without cardiac surgery, with excellent outcomes in a large, high-risk population. Primary PTCA in appropriate patients can be performed consistently, rapidly and with success and complication rates similar to those of experienced high-volume surgical centers (Figure 6) and better than those reported in any study of thrombolytic therapy. Because of its broader applicability and greater safety and efficacy, primary PTCA should be offered as the standard-of-care for patients with AMI at more of the qualified hospitals that do not have cardiac surgery. To do this requires intensive collaboration and commitment of all members of the health care team to assure the success of this effort. Necessary elements of such programs include following standards and criteria such as those listed in Tables 1 and 2, rapid triage of AMI patients from the ED to the CCL, critical pathways and care plans to cover every aspect of management of the AMI patient from first contact through discharge, ongoing assessment of evolving protocols to improve patient care, continuous educational programs to update staff on the latest therapeutics and pharmacology, data collection, outcomes monitoring and quality assurance programs, and a transfer protocol and agreement with a cardiac surgery program for immediate triage of surgical patients. Physicians, nurses, administrators, and the medical community must work together with legislative bodies to change overly-restrictive and outdated regulations in many states. Newer guidelines must reflect the enormous compilation of outcomes from national and international registries which support primary PTCA at non cardiac centers. It is now not only possible but also necessary to expand the availability of this potentially life-saving therapy to more patients with acute myocardial infarction in more hospitals throughout the country (Figure 7). The Rest of the Story¦ John was still in shock in the cardiac cath lab. The cardiologist, discovering the right coronary artery occlusion with large thrombus, successfully reopened it with a 3.5mm x 30 mm balloon, restoring brisk (TIMI Grade 3) flow to the right coronary artery 35 minutes after John arrived in the cath lab (Figure 8). The ST segments immediately came down. Within a few more minutes the cardiogenic shock cleared and John could be weaned from pressors to IV nitroglycerin and beta blockers. John woke up, pink, pain-free, and in good spirits. His ejection fraction at the end of the procedure was 50%. His wife was elated at this rapid and dramatic resurrection. Several days later, and with no further GI bleeding, he underwent an endoscopy where two healing ulcers were identified. He was discharged home on hospital day 5 with follow-up care arranged. He was able to exercise 10 minutes on the treadmill several months later. He and his wife have enjoyed many more Thanksgiving meals together with their family.

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