- Email: [email protected]
Safety of elective—including “high risk”—percutaneous coronary interventions without on-site cardiac surgery
Safety of elective—including “high risk”—percutaneous coronary interventions without on-site cardiac surgery Edgardo Zavala-Alarcon, MD, FACC, FSCAI,a,b,c Felipe Cecena, MD, FACC, FSCAI,c Rajiv Ashar, MD,c Rajul Patel, MD, FACC,c Scott Van Poppel, MD,c and Richard Carlson, MD, PhD, FACPb,c Phoenix, Ariz, and Minneapolis, Minn
Background Current guidelines (American College of Cardiology/American Heart Association) for percutaneous coronary intervention (PCI) limit the performance of elective cases to hospitals with the capability for cardiac surgery. The number of hospitals in the United States with this capability is limited, which restricts availability of this proven technology. Objective To determine the safety of performing elective, nonselected PCI in hospitals without cardiac surgery capability. Design, setting, and patients A single-center retrospective analysis of the first 1000 patients undergoing elective, including “high-risk,” PCI in the county hospital in Phoenix, Arizona.
Main outcome measures A database (Access Microsoft Windows) was established to follow patient characteristics, indications for the procedure, technical aspects of the procedure, outcomes and complications. The Quality Improvement Committee followed each case closely to independently assess the adequacy of indications and patient management, with a monthly case review of every patient who had a periprocedural or postprocedural complication. Results
Failure to complete target vessel revascularization occurred in 68 of the total 1756 vessels (3.8%). Seven patients (0.7%), required elective referral for coronary artery bypass graft surgery after failed PCI. Coronary perforations occurred in 9 patients (0.9%); all resolved with percutaneous techniques. Postprocedure myocardial infarction was diagnosed in 21 patients (2.1%). Two patients (0.2%) developed a stroke. Periprocedural death (within 48 hours of the procedure) occurred in 2 patients (0.2%). Out of the 1000 interventions performed, none required emergency coronary artery bypass graft surgery.
Conclusions Technical advances in interventional cardiology allow for safe performance of PCI in hospitals without on-site cardiac surgery facilities if proposed conditions are met. Our results together with the vast experience in other countries supports a paradigm change that would increase the number of hospitals that can offer interventional cardiology procedures with a corresponding increase in the number of patients that would benefit. (Am Heart J 2004;148:676 – 83.) Current guidelines from the American College of Cardiology/American Heart Association (ACC/AHA) for percutaneous coronary intervention (PCI) recommend the performance of elective PCI only in hospitals with cardiac surgery capabilities. The performance of primary PCI for patients with acute ST-elevation myocardial infarction or new left bundle-branch block in the clinical setting of acute myocardial infarction is considered a class IIb indication if high-volume operators and an institution with a From the aDepartment of Medicine, University of Arizona School of Medicine, Phoenix, Ariz, bDepartment of Medicine, Mayo Clinic School of Medicine, Minneapolis, Minn, and cCardiology Department, Maricopa Medical Center, Phoenix, Ariz Submitted December 12, 2003; accepted March 30, 2004. Reprint requests: Edgardo Zavala-Alarcon, MD, Cardiology Department, Maricopa Medical Center, 2601 East Roosevelt Street, Phoenix, AZ 85008 E-mail: [email protected] 0002-8703/$ - see front matter © 2004, Elsevier Inc. All rights reserved. doi:10.1016/j.ahj.2004.03.040
high volume are available along with an established proven plan for rapid access to cardiac surgery at a nearby facility within 1 hour.1 Since the first coronary angioplasty by Gruentzig in 1977, the role of emergency coronary artery bypass graft (CABG) surgery following failed PCI has changed dramatically. Increasing operator expertise together with significant technical advances including generalized use of intracoronary stents and new antiplatelet therapies have reduced the need for emergency CABG surgery to ⬍0.5%.2–5 We report our observational experience in the first 1000, elective, nonselected PCI procedures in a hospital without on-site cardiac surgery capability.
Methods Maricopa Medical Center (MMC) is the county hospital in Phoenix, Arizona. It is a full-service, 541-bed hospital that sees nearly 20,000 inpatient admissions every year.
American Heart Journal Volume 148, Number 4
Maricopa Integrated Health System (MIHS) is the health care safety net for citizens of Maricopa County. The health system serves people of many races and nationalities who come from diverse cultures and speak several different languages. Many of the patients face major challenges, such as lack of health insurance, complex medical problems, and difficult socioeconomic situations. In August 1998 we opened our diagnostic cardiac catheterization laboratory, staffed from the beginning by 2 experienced interventional cardiologists who routinely performed PCI at nearby facilities that have on-site cardiac surgery. The technical and nursing staff was also experienced in periprocedural and postprocedural care. Over 4000 diagnostic procedures have been performed since then, requiring the addition of another interventional cardiologist to the full-time staff. During the first 2 years, patients requiring coronary intervention were transferred to a nearby hospital for either CABG surgery or elective PCI, performed by our own cardiology staff. In October of 2000, we launched the interventional program at MMC. Patient eligibility protocols were developed and approved by the internal review board at MMC. During the first 3 months, only “low-risk” cases were approved for PCI, but with the growing demand and enormous success of the program, a decision was made to perform all cases at MMC. Patients were given the option to be transferred to nearby hospitals for their intervention after thorough explanation of the procedure and clear understanding that emergency cardiac surgery could not be performed on-site. Only 11 patients elected the alternative option. Eighty-three patients had their procedure, diagnostic and/or interventional, at the surgical facility, due to overload of our own cardiac catheterization laboratory. From the beginning, a database (Access Microsoft Windows) was established to follow patients characteristics, indications for the procedure, technical aspects of the procedure, outcomes and complications. The Quality Improvement (QI) committee followed each case closely and collected the data to independently assess the adequacy of indications and patient management, and conducted a monthly case review of every patient who had a peri- or postprocedural complication. Immediate transfer for emergency CABG surgery was ensured with an arrangement with emergency medical services to transport patients to a nearby medical center, located 1.5 miles away. The cardiac catheterization laboratory was fully equipped, including intra-aortic balloon pumps (IABP), thrombectomy equipment, and polytetrafluoroethylene (PTFE)-covered stents to provide necessary support to manage complications and provide safe transfer in case of need. The first 1000 elective cases are the subject of this report. During this period, 89 primary angioplasties (in patients with acute ST-elevation myocardial infarction) were performed with excellent outcomes, but are not considered in this report since the focus of this paper is on elective PCI.
Interventional procedure PCI was performed during the initial diagnostic catheterization (ad hoc) in most cases (96%). Use of eptifibatide or tirofiban was routine except when clear contraindications ex-
Zavala-Alarcon et al 677
isted and overall were used in 978 patients (97.8%). Heparin was used as a 60 units per kilogram body weight bolus before the intervention. Activated clotting time was measured only during very prolonged and complicated interventions when the operator considered that extra heparin might be necessary. All patients received clopidogrel 300 mg after completion of the procedure and 75 mg per day at least during the first month postprocedure, along with aspirin 81 mg. Stents were used in most interventions, with 1636 stents used in a total of 1759 vessels that were intervened (93%). Prophylactic IABP was used at the discretion of the operator for high-risk intervention in patients with poor left ventricular function undergoing multivessel stenting or unprotected left main intervention. Only 19 patients (1.9%) received the IABP.
Patient characteristics The clinical characteristics of our population showed a significant predominance of male patients (632; 63%) versus female patients. The mean age was 63 years (range 35–92). Main comorbidities are depicted in Figure 1.
Angiographic characteristics Interventions were performed in 1759 vessels in our first 1000 patients, with an average of 1.7 vessels per patient. Distribution of revascularized vessels is depicted in Figure 2. In 49 patients with previous CABG surgery, the left main coronary artery was intervened (4.9% of patients). Nineteen patients (1.9% of all patients) had unprotected left main intervention. PCI was performed in these patients either because of patient preference with refusal to undergo CABG surgery or because the patient was considered not eligible for surgery after consultation with cardiac surgery. Single-vessel intervention was performed in 469 patients (46.9%). Two-vessel intervention was performed in 348 patients (34.8%), and 3-vessel intervention was performed in 156 patients (15.6%). Four or more vessels were revascularized in 27 patients (2.7%). Chronic total occlusions (CTOs) were successfully revascularized in 28 patients (2.8%) and failed in 35 vessels. Overall success rate, considered as target vessel revascularization with ⬍30% residual stenosis, was 96.2% (Figure 2). Analysis of the type of lesions (ACC/AHA classification) that were revascularized showed 27% were type A lesions, 22% type B1, 31% type B2, and 20% type C (Figure 3).
Complications Failure to complete target vessel revascularization (TVR) occurred in 68 of the total 1756 vessels (3.8%), with a majority occurring in CTOs (35 vessels). Seven patients (0.7%) required elective referral for CABG surgery after failed PCI, with the remaining patients opting for medical treatment (32 patients). Non-planned IABP placement due to hemodynamic instability occurred in 7 patients (0.7%), with all of them ending up having successful revascularization and uneventful recovery. Coronary perforations occurred in 9 patients (0.9%). Four of these patients required emergent pericardiocentesis due to tamponade. Five vessels were successfully treated with a covered stent (Jomed stent), and in 3 patients the perfo-
American Heart Journal October 2004
678 Zavala-Alarcon et al
Figure 1
Patient comorbidities.
Figure 2
Vessels intervened.
ration was treated with reversal of anticoagulation together with prolonged perfusion balloon inflation. One patient had a perforation involving the distal segment of the vessel and required treatment with coil embolization. Two of these patients with perforation had enzyme eleva-
tion postprocedure that was diagnostic of periprocedural myocardial infarction. Three patients (0.3%) required cardiopulmonary resuscitation and intubation during the interventional procedure with successful results and uneventful recovery.
American Heart Journal Volume 148, Number 4
Figure 3
Lesion types, ACC/AHA classification.
Postprocedure MI was diagnosed when the creatine phosphokinase-MB was ⬎3 times the baseline level; this occurred in 21 patients (2.1%), including the patients already described that had coronary perforations. Two patients (0.2%) developed a stroke after their PCI (within 48 hours) with no evidence of intracranial bleed on computed tomography (CT). Each patient required an extended hospital stay with residual neurologic sequelae. In 39 patients (3.9%), access site hematomas (⬎3 cm in size) were diagnosed that did not require blood transfusion or further intervention, with all of them recovering uneventfully. In 6 patients (0.6%), major access site complications occurred, including need for transfusion (5 patients), surgical revision (2 cases of femoral artery pseudoaneurysm and 1 case of brachial artery occlusion) or percutaneous intervention (1 to treat an occlusive dissection in an iliac artery treated with stent placement and 1 case with iliac perforation treated with a covered stent [Wallgraft]). Two patients (0.2%), developed progressive renal failure attributed to the procedure that stabilized with medical management not requiring dialysis. Periprocedural death (within 48 hours of the procedure) occurred in two patients (0.2%), with 11 inhospital deaths (1.1%). The deaths of 9 other patients during the same hospitalization when the PCI was performed were considered unrelated to the procedure; they occurred as the result of other multiple medical or surgical conditions. The 2 cases of periprocedural death were related to bleeding complications while on tirofiban, without evidence of vascular injury on emergent angiography. Of significant interest is the fact that out of the 1000 interventions performed, no case required emergency CABG surgery (Figure 4).
Discussion The early experience with PCI was characterized by frequent complications, including coronary dissection, acute recoil, coronary perforation, and coronary thrombosis.6 The early years demanded “surgical standby” for emergency CABG surgery, which was frequently required to salvage patients from these dreaded complications. The performance of PCI was predicated on the availability of on-site cardiac surgery.
Zavala-Alarcon et al 679
In many foreign countries, the formal requirement for on-site cardiac surgery for the performance of PCI has slowly changed. In the British Cardiac Society Guidelines, of 20,511 PCI procedures performed in the United Kingdom in 1996, 1382 (7%) were performed in 6 centers without on-site cardiac surgical capabilities.7 Emergency CABG within 24 hours was required in 1.5% of patients. Surgical backup, whether on-site or off-site, was recommended for all coronary angioplasty procedures.7 In Israel, a recent publication8 reports 11 years of experience of performing PCI without surgical support. In Canada, the Cardiac Care Network of Ontario9 has recommended to the Ontario Ministry of Health that pilot programs be set up in Ontario to perform coronary angioplasty (both primary and elective) at hospitals without on-site surgical backup. Increasing experience in PCI as well as several technical improvements, primarily the routine use of stents, has dramatically reduced the need for emergency surgical revascularization. The role of heart surgery has switched from the emergency treatment of the frequent complications of PCI to the timely revascularization of subjects not suitable for percutaneous interventions. Thus, the performance of PCI at centers without on-site surgical facilities is gaining widespread acceptance. Loubeyre et al2 reported a retrospective (1995) and prospective (1996) registry that analyzed the incidence, indication, and results of emergency CABG surgery performed within 24 hours of PCI in 68 and 57 centers, respectively, accounting for nearly half of all angioplasty procedures in France. Over the 2 years, 26,885 and 27,497 procedures were investigated, with a stenting rate of 46% and 64%, respectively. The observed need for emergency surgery was constantly low throughout this period (0.38% and 0.32%, respectively). Indications for surgery included complications directly due to PCI in 37% of cases in the 2-year period. Outcome remained poor, with inhospital mortality in 10% and 17% and myocardial infarction in 27% and 25% of cases, respectively. A comparison of the results in centers with and without surgical facilities showed no differences in outcome, despite a longer time to surgery (359 min ⫾ 406 min vs 170 min ⫾ 205 min, P ⫽ .0001) and a lower incidence of emergency surgery (0.25% versus 0.44%, P ⫽ .0001) in centers without on-site surgery backup. The French multicenter registry revealed an increase in the use of stents together with a dramatic decrease in the incidence of emergency CABG surgery (below 0.5%) following PCI. In the United States, Ting et al10 studied the safety and efficacy of performing low-risk elective and acute infarct PCI at a community hospital without cardiac surgical capability. Procedural success was achieved in 195 (99.5%) patients, with 1 (0.5%) inhospital death.
American Heart Journal October 2004
680 Zavala-Alarcon et al
Figure 4
Complications.
No patients required transfer to another facility for emergent cardiac surgery for a procedure-related complication. They conclude that low-risk elective and acute infarct PCI can be performed with safety and efficacy at a community hospital without cardiac surgical capability by following rigorous standards. The complications of PCI that can lead to emergency surgery are: 1) flow limiting dissection; 2) abrupt closure; 3) occlusion of a large side branch during the procedure, with an inability to restore patency percutaneously; and 4) coronary artery perforation. In recent years, there has been a steady decline in the frequency of dissections and abrupt closures. The explanations are multifactorial, but the use of coronary artery stents has been the most important factor.11 Glycoprotein IIb/IIIa receptor inhibitors also reduce the need for emergency CABG in patients undergoing PCI.12 In an analysis of pooled data from 2 trials (Evaluation of Platelet IIb/IIIa Inhibitor for Stenting and Evaluation of Percutaneous Transluminal Coronary Angioplasty to Improve Long-term Outcome With Abciximab Glycoprotein IIb/IIIa Blockade), the incidence of cardiac surgical procedures was 1.28% in patients receiving abciximab, which is substantially lower than the incidence of 2.17% in the placebo group (relative risk reduction 41%, P ⫽ .021).12 Coronary perforations, particularly if they are severe or occur in patients treated with glycoprotein IIb/IIIa inhibitors, may not respond to prolonged balloon inflation or pericardiocentesis and may require emergency CABG surgery, but this complication is rare.13 Use of a coronary stent covered with PTFE membrane reduces the need for CABG in such cases.14
The establishment of cardiac surgery programs for the sole purpose of supporting PCI is quite controversial. The surgical volume will most likely be insufficient to be cost-effective but also outcomes might be jeopardized. Immediate death rates (death during the hospital admission) with CABG surgery vary widely, from lows of 1% to highs approaching 15% and perhaps higher. Research from the United States demonstrates clearly that there is a volume effect. Centers and surgeons with higher volumes have lower immediate mortality. The volume effect persists even at relatively high levels, that is, ⬎650 procedures a year for a hospital and ⬎116 procedures a year for a physician. This fact strongly supports regulation to centralize CABG surgery facilities.15 A recent study16 showed how mortality decreased (P ⬍ .001) with increasing volume (3.6% in low [⬍500 cases], 3.0% in moderate [500 –1000 cases], and 2.0% in high [⬎1000 cases] volume hospitals). The impact of new technology, specifically the availability of drug-eluting stents, will clearly have an impact on CABG surgery volume. Surgical indications will be further reduced to the technical pitfalls of stenting (complex or tortuous anatomy, chronic occlusions, multiple tandem lesions). An important question is whether the availability of on-site cardiac surgery influences the interventionist in deciding for surgical referral against a more aggressive PCI approach to solve the complication. Results of emergency CABG surgery after PCI complications are poor even in hospitals with on-site cardiac surgery.2 In a recent review,17 emergency CABG surgery for failed PCI is still associated with important morbidity and
American Heart Journal Volume 148, Number 4
mortality. In 18,593 PCI procedures performed from 1992 through 2000, there was a need for emergency CABG surgery in 113 (0.61%) cases. The major indications were extensive dissection (n ⫽ 61, 54%), perforation/tamponade (n ⫽ 23, 20%), and recurrent acute closure (n ⫽ 23, 20%). Prevalence of emergency CABG surgery decreased from 1.5% of PCI cases in 1992 to 0.14% in 2000 (P ⬍ .001) In patients undergoing emergency CABG surgery, there were 17 (15%) inhospital deaths, 14 (12%) perioperative Q-wave myocardial infarctions, and 6 (5%) strokes. The experience and competency of the interventionist is clearly an important factor. There is clearly an association between institutional and individual procedural volumes and clinical outcome, including mortality.18 Current American College of Cardiology/American Heart Association (ACC/AHA) recommendations suggest that an individual operator should perform at least 75 cases annually to remain competent.1 Hamad et al19 studied the results of 781 PCI procedures performed at 1 institution by either high- (⬎100 procedures per year) or low-volume operators (⬍100 procedures per year) and concluded that low-volume operators had poorer outcomes when more complex lesions were involved. Another study20 involving 2350 PCIs performed by high- (⬎50/y) and low-volume operators (⬍50/y) at a single institution found differences in the rates of emergency CABG surgery (2.1% for high-volume, 3.9% for low-volume operators . Jollis et al21 studied 1992 Medicare discharge abstracts for 97,478 patients who had PCI performed by 6115 physicians. The rates for inhospital CABG surgery were 3.8%, 3.4%, and 2.6% for patients treated by physicians with an average volume of ⬍25, 25–50, and ⬎50 PCI procedures per year, respectively (P ⬍ .001). A study of the 1991 to 1994 New York State experience,22 with 62,670 patients treated by ⬎100 physicians, discovered significant differences in patients undergoing PCI performed by cardiologists with annual volumes ⬍75/year. These patients had a risk-adjusted mortality rate of 1.03%, compared with 0.90% for all patients, and a same-stay risk-adjusted CABG surgery rate of 3.95%, compared with 3.43% for all patients. Ellis et al23 analyzed databases from 5 high-volume centers involving 12,985 patients undergoing PCIs during 1993 to 1994 and also found a significant, inverse relation between operator volume and the combined end point of death, Q-wave myocardial infarction, or the need for emergency CABG surgery. The relationship of appropriate revascularization to the availability of PCI capability has been reported. Women, ethnic minorities, and uninsured persons receive fewer cardiac procedures than affluent white male patients do.24 Hospitals that provided on-site revascularization had higher use rates (76%) than hospitals that did not provide it (59%). In hospitals that did
Zavala-Alarcon et al 681
Figure 5
NMRI registry. Among the 1506 participating registry hospitals, 423 (28.1%) were classified as noninvasive, 380 (25.2%) as cathcapable, 112 (7.4%) as percutaneous coronary angiography-capable and 591 (39.2%) as CABG-capable. From Rogers et al.26
not provide on-site revascularization, uninsured patients were less likely to have revascularization recommended to them (52%). The availability of qualified hospitals and operators is the chief limitation to the widespread application of PCI in patients who require it. Approximately 840 community hospitals in the United States that have cardiac catheterization laboratories do not have cardiac surgery facilities.25 A report of the National Registry of Myocardial Infarction (NRMI-2) showed that among the 1506 participating registry hospitals, 423 (28.1%) were classified as noninvasive, 380 (25.2%) as catheterization-capable, 112 (7.4%) as percutaneous transluminal coronary angioplasty-capable, and 591 (39.2%) as CABG-capable (Figure 5).26 Many of these hospitals are staffed by experienced and active interventionalists. In view of the growing population in need of PCI and the decreasing role of CABG surgery to revascularize these patients, the established requirement to have on-site cardiac surgical capability has to be reviewed to evaluate whether PCI can be extended safely and effectively to these primary care hospitals. This paper reports for the first time in the United States the safety of performing elective, non selected, including high-risk cases of PCI in a hospital without cardiac surgery capability. Our experience is significant since it mimics the conditions present in many hospitals in this country, where experienced interventionalists are available and where diagnostic cardiac catheterization laboratories are underutilized due to the dogma of the requirement for surgical back-up. We believe that our results together with the vast experience in other countries supports a paradigm change that would increase the number of hospitals that can offer interventional cardiology procedures with a corresponding increase in the number of patients that would benefit.
American Heart Journal October 2004
682 Zavala-Alarcon et al
We suggest the following standards for the performance of elective and primary angioplasty at community hospitals without cardiac surgery: ● The operators must be experienced interventionalists who regularly perform elective intervention. ● The nursing and technical catheterization laboratory staff must be experienced in handling acutely ill patients and comfortable with interventional equipment. They must have acquired experience in dedicated angioplasty laboratories at a surgical center. They must participate in a 24hour 365-day call schedule. ● The catheterization laboratory itself must be well equipped, with optimal imaging systems, resuscitative equipment, and IABP support, and must be well stocked with a broad array of interventional equipment. ● The cardiac care unit nurses must be adept in hemodynamic monitoring and IABP management. ● The hospital administration must fully support the program and enable the fulfillment of the above institutional requirements. ● Formalized written protocols for immediate and efficient transfer of patients to the nearest cardiac surgical facility must be in place. ● The volume of yearly procedures performed by each operator should be high enough (according to ACC/AHA guidelines) to ensure continued competency. ● Primary intervention must be performed routinely as the treatment of choice around the clock for a large proportion of patients with acute myocardial infarction, to ensure streamlined care paths and increased case volumes. ● There must be an ongoing program of outcomes analysis and formalized periodic case review.
Limitations This is a single-center experience. Conditions required to establish a safe elective PCI program might be difficult to meet at other hospitals. We believe, however, that results similar to ours can be achieved by cardiologists and institutions that establish programs that adopt rigorous standards such as those proposed. Our data were collected retrospectively, although complications were followed on a daily basis by an experienced nurse with expertise in quality assurance programs. The hospital quality assurance committee evaluated each complicated case during monthly meetings. A team of independent consultants was assigned by the hospital administration to evaluate the appropriateness of the interventional program. Their findings supported the continuation of the program. We thank the hospital administration at Maricopa Medical Center without whose enthusiastic support this work would not have been possible. The excellent work of Ellen Horton, RN, in data collection and Curt Bay, PhD, in statistical analysis is paramount to the publication of our work. We particularly wish to
acknowledge the invaluable contributions of the catheterization laboratory team, Jeff Weddle, RN, Ann Kelly, RN, Kelly Johansen, RN, and David Pigg, RT, whose dedicated service and commitment to an intensive work schedule were integral to the success of our program. Special mention must be made of our cardiovascular technician, Vincent Romero, who contributed his experience and skills to the excellent outcomes achieved.
References 1. Smith SC Jr, Dove JT, Jacobs AK, et al. ACC/AHA guidelines for percutaneous coronary intervention (revision of the 1993 PTCA guidelines)— executive summary: a report of the American College of Cardiology/American Heart Association task force on practice guidelines (Committee to revise the 1993 guidelines for percutaneous transluminal coronary angioplasty) endorsed by the Society for Cardiac Angiography and Interventions. Circulation 2001;103: 3019 – 41. 2. Loubeyre C, Morice MC, Berzin B, et al. Emergency coronary artery bypass surgery following coronary angioplasty and stenting: results of a French multicenter registry. Catheter Cardiovasc Interv 1999;47:441– 8. 3. Karvouni E, Katritsis DG, Ioannidis JP. Intravenous glycoprotein IIb/IIIa receptor antagonists reduce mortality after percutaneous coronary interventions. J Am Coll Cardiol 2003;41:26 –32. 4. McGrath PD, Malenka DJ, Wennberg DE, et al. Changing outcomes in percutaneous coronary interventions: a study of 34,752 procedures in northern New England, 1990 to 1997. J Am Coll Cardiol 1999;34:674 – 80. 5. Tamburino C, Russo G, Nicosia A, et al. Prophylactic abciximab in elective coronary stenting: results of a randomized trial. J Invasive Cardiol 2002;2:72–9. 6. Holmes DR Jr, Holubkov R, Vlietstra RE, et al. Comparison of complications during percutaneous transluminal coronary angioplasty from 1977 to 1981 and from 1985 to 1986: the National Heart, Lung, and Blood Institute Percutaneous Transluminal Coronary Angioplasty Registry. J Am Coll Cardiol 1988;12:1149 –55. 7. Joint Working Group on Coronary Angioplasty of the British Cardiac Society and British Cardiovascular Intervention Society. Coronary angioplasty: guidelines for good practice and training. Heart 2000;83:224 –35. 8. Turgeman Y, Atar S, Suleiman K, et al. Diagnostic and therapeutic percutaneous cardiac interventions without on-site surgical backup—review of 11 years experience. Isr Med Assoc J 2003;5:89 – 93. 9. Cardiac Care Network of Ontario. Available at: http://www.ccn. on.ca. Accessed February 5, 2002. 10. Ting HH, Garratt KN, Tiede DJ, et al. (2000) Percutaneous coronary intervention at two community hospitals without on-site cardiac surgical services supported with telemedicine [abstract]. Circulation 2000;102(Suppl II):II735. 11. Holmes DR Jr, Hirshfeld J Jr, Faxon D, et al. ACC expert consensus document on coronary artery stents: document of the American College of Cardiology. J Am Coll Cardiol 1998;32:1471– 82. 12. Lincoff AM, LeNarz LA, Despotis GJ, et al. Abciximab and bleeding during coronary surgery: results from the EPILOG and EPISTENT trials. Ann Thorac Surg 2000;70:516 –26.
American Heart Journal Volume 148, Number 4
13. Ellis SG, Ajluni S, Arnold AZ, et al. Increased coronary perforation in the new device era: incidence, classification, management, and outcome. Circulation 1994;90:2725–30. 14. Briguori C, Nishida T, Anzuini A, et al. Emergency polytetrafluoroethylene-covered stent implantation to treat coronary ruptures. Circulation 2000;102:3028 –31. 15. Banta D, Bos M. The relation between quantity and quality with coronary artery bypass graft (CABG) surgery. Health Policy 1991; 18:1–10. 16. Rosenthal GE, Vaughan Sarrazin M, et al. In-hospital mortality following coronary artery bypass graft surgery in Veterans Health Administration and private sector hospitals. Med Care 2003;41: 522–35. 17. Seshadri N, Whitlow PL, Acharya N, et al. Emergency coronary artery bypass surgery in the contemporary percutaneous coronary intervention era. Circulation 2002;106:2346 –50. 18. McGrath PD, Wennberg DE, Dickens JD. Relation between operator and hospital volume and outcomes following percutaneous coronary interventions in the era of the coronary stent [Interventional Cardiology Abstracts]. ACC Curr J R 2001;10(4). 19. Hamad N, Pichard AD, Lyle HRP, et al. Results of percutaneous transluminal coronary angioplasty by multiple, relatively low frequency operators: 1986 –1987 experience. Am J Cardiol 1998; 61:1229 –31.
Zavala-Alarcon et al 683
20. Shook TL, Sun GW, Burstein S, et al. Comparison of percutaneous transluminal coronary angioplasty outcome and hospital costs for low-volume and high-volume operators. Am J Cardiol 1996;77: 331–36. 21. Jollis JG, Peterson ED, Nelson CL, et al. Relationship between physician and hospital coronary angioplasty volume and outcome in elderly patients. Circulation 1997;96:2485–91. 22. Hannan EL, Racz M, Ryan TJ, et al. Coronary angioplasty volume– outcome relationships for hospitals and cardiologists. JAMA 1997; 279:892– 8. 23. Ellis SG, Weintraub W, Holmes D, et al. Relation of operator volume and experience to procedural outcome of percutaneous coronary revascularization at hospitals with high interventional volumes. Circulation 1997;96:2479 – 84. 24. Leape LL, Hilborne LH, Bell R, et al. Underuse of cardiac procedures: do women, ethnic minorities, and the uninsured fail to receive needed revascularization? Ann Intern Med 1999;130:183–92. 25. Directory of Cardiac Catheterization Laboratories in the United States. 4th ed. Raleigh (NC): The Society for Cardiac Angiography and Interventions; 1997. 26. Rogers WJ, Canto JG, Barron HV, et al. Investigators in the National Registry of Myocardial Infarction Treatment and outcome of myocardial infarction in hospitals with and without invasive capability. J Am Coll Cardiol 2000;35:371–9.
Background Current guidelines (American College of Cardiology/American Heart Association) for percutaneous coronary intervention (PCI) limit the performance of elective cases to hospitals with the capability for cardiac surgery. The number of hospitals in the United States with this capability is limited, which restricts availability of this proven technology. Objective To determine the safety of performing elective, nonselected PCI in hospitals without cardiac surgery capability. Design, setting, and patients A single-center retrospective analysis of the first 1000 patients undergoing elective, including “high-risk,” PCI in the county hospital in Phoenix, Arizona.
Main outcome measures A database (Access Microsoft Windows) was established to follow patient characteristics, indications for the procedure, technical aspects of the procedure, outcomes and complications. The Quality Improvement Committee followed each case closely to independently assess the adequacy of indications and patient management, with a monthly case review of every patient who had a periprocedural or postprocedural complication. Results
Failure to complete target vessel revascularization occurred in 68 of the total 1756 vessels (3.8%). Seven patients (0.7%), required elective referral for coronary artery bypass graft surgery after failed PCI. Coronary perforations occurred in 9 patients (0.9%); all resolved with percutaneous techniques. Postprocedure myocardial infarction was diagnosed in 21 patients (2.1%). Two patients (0.2%) developed a stroke. Periprocedural death (within 48 hours of the procedure) occurred in 2 patients (0.2%). Out of the 1000 interventions performed, none required emergency coronary artery bypass graft surgery.
Conclusions Technical advances in interventional cardiology allow for safe performance of PCI in hospitals without on-site cardiac surgery facilities if proposed conditions are met. Our results together with the vast experience in other countries supports a paradigm change that would increase the number of hospitals that can offer interventional cardiology procedures with a corresponding increase in the number of patients that would benefit. (Am Heart J 2004;148:676 – 83.) Current guidelines from the American College of Cardiology/American Heart Association (ACC/AHA) for percutaneous coronary intervention (PCI) recommend the performance of elective PCI only in hospitals with cardiac surgery capabilities. The performance of primary PCI for patients with acute ST-elevation myocardial infarction or new left bundle-branch block in the clinical setting of acute myocardial infarction is considered a class IIb indication if high-volume operators and an institution with a From the aDepartment of Medicine, University of Arizona School of Medicine, Phoenix, Ariz, bDepartment of Medicine, Mayo Clinic School of Medicine, Minneapolis, Minn, and cCardiology Department, Maricopa Medical Center, Phoenix, Ariz Submitted December 12, 2003; accepted March 30, 2004. Reprint requests: Edgardo Zavala-Alarcon, MD, Cardiology Department, Maricopa Medical Center, 2601 East Roosevelt Street, Phoenix, AZ 85008 E-mail: [email protected] 0002-8703/$ - see front matter © 2004, Elsevier Inc. All rights reserved. doi:10.1016/j.ahj.2004.03.040
high volume are available along with an established proven plan for rapid access to cardiac surgery at a nearby facility within 1 hour.1 Since the first coronary angioplasty by Gruentzig in 1977, the role of emergency coronary artery bypass graft (CABG) surgery following failed PCI has changed dramatically. Increasing operator expertise together with significant technical advances including generalized use of intracoronary stents and new antiplatelet therapies have reduced the need for emergency CABG surgery to ⬍0.5%.2–5 We report our observational experience in the first 1000, elective, nonselected PCI procedures in a hospital without on-site cardiac surgery capability.
Methods Maricopa Medical Center (MMC) is the county hospital in Phoenix, Arizona. It is a full-service, 541-bed hospital that sees nearly 20,000 inpatient admissions every year.
American Heart Journal Volume 148, Number 4
Maricopa Integrated Health System (MIHS) is the health care safety net for citizens of Maricopa County. The health system serves people of many races and nationalities who come from diverse cultures and speak several different languages. Many of the patients face major challenges, such as lack of health insurance, complex medical problems, and difficult socioeconomic situations. In August 1998 we opened our diagnostic cardiac catheterization laboratory, staffed from the beginning by 2 experienced interventional cardiologists who routinely performed PCI at nearby facilities that have on-site cardiac surgery. The technical and nursing staff was also experienced in periprocedural and postprocedural care. Over 4000 diagnostic procedures have been performed since then, requiring the addition of another interventional cardiologist to the full-time staff. During the first 2 years, patients requiring coronary intervention were transferred to a nearby hospital for either CABG surgery or elective PCI, performed by our own cardiology staff. In October of 2000, we launched the interventional program at MMC. Patient eligibility protocols were developed and approved by the internal review board at MMC. During the first 3 months, only “low-risk” cases were approved for PCI, but with the growing demand and enormous success of the program, a decision was made to perform all cases at MMC. Patients were given the option to be transferred to nearby hospitals for their intervention after thorough explanation of the procedure and clear understanding that emergency cardiac surgery could not be performed on-site. Only 11 patients elected the alternative option. Eighty-three patients had their procedure, diagnostic and/or interventional, at the surgical facility, due to overload of our own cardiac catheterization laboratory. From the beginning, a database (Access Microsoft Windows) was established to follow patients characteristics, indications for the procedure, technical aspects of the procedure, outcomes and complications. The Quality Improvement (QI) committee followed each case closely and collected the data to independently assess the adequacy of indications and patient management, and conducted a monthly case review of every patient who had a peri- or postprocedural complication. Immediate transfer for emergency CABG surgery was ensured with an arrangement with emergency medical services to transport patients to a nearby medical center, located 1.5 miles away. The cardiac catheterization laboratory was fully equipped, including intra-aortic balloon pumps (IABP), thrombectomy equipment, and polytetrafluoroethylene (PTFE)-covered stents to provide necessary support to manage complications and provide safe transfer in case of need. The first 1000 elective cases are the subject of this report. During this period, 89 primary angioplasties (in patients with acute ST-elevation myocardial infarction) were performed with excellent outcomes, but are not considered in this report since the focus of this paper is on elective PCI.
Interventional procedure PCI was performed during the initial diagnostic catheterization (ad hoc) in most cases (96%). Use of eptifibatide or tirofiban was routine except when clear contraindications ex-
Zavala-Alarcon et al 677
isted and overall were used in 978 patients (97.8%). Heparin was used as a 60 units per kilogram body weight bolus before the intervention. Activated clotting time was measured only during very prolonged and complicated interventions when the operator considered that extra heparin might be necessary. All patients received clopidogrel 300 mg after completion of the procedure and 75 mg per day at least during the first month postprocedure, along with aspirin 81 mg. Stents were used in most interventions, with 1636 stents used in a total of 1759 vessels that were intervened (93%). Prophylactic IABP was used at the discretion of the operator for high-risk intervention in patients with poor left ventricular function undergoing multivessel stenting or unprotected left main intervention. Only 19 patients (1.9%) received the IABP.
Patient characteristics The clinical characteristics of our population showed a significant predominance of male patients (632; 63%) versus female patients. The mean age was 63 years (range 35–92). Main comorbidities are depicted in Figure 1.
Angiographic characteristics Interventions were performed in 1759 vessels in our first 1000 patients, with an average of 1.7 vessels per patient. Distribution of revascularized vessels is depicted in Figure 2. In 49 patients with previous CABG surgery, the left main coronary artery was intervened (4.9% of patients). Nineteen patients (1.9% of all patients) had unprotected left main intervention. PCI was performed in these patients either because of patient preference with refusal to undergo CABG surgery or because the patient was considered not eligible for surgery after consultation with cardiac surgery. Single-vessel intervention was performed in 469 patients (46.9%). Two-vessel intervention was performed in 348 patients (34.8%), and 3-vessel intervention was performed in 156 patients (15.6%). Four or more vessels were revascularized in 27 patients (2.7%). Chronic total occlusions (CTOs) were successfully revascularized in 28 patients (2.8%) and failed in 35 vessels. Overall success rate, considered as target vessel revascularization with ⬍30% residual stenosis, was 96.2% (Figure 2). Analysis of the type of lesions (ACC/AHA classification) that were revascularized showed 27% were type A lesions, 22% type B1, 31% type B2, and 20% type C (Figure 3).
Complications Failure to complete target vessel revascularization (TVR) occurred in 68 of the total 1756 vessels (3.8%), with a majority occurring in CTOs (35 vessels). Seven patients (0.7%) required elective referral for CABG surgery after failed PCI, with the remaining patients opting for medical treatment (32 patients). Non-planned IABP placement due to hemodynamic instability occurred in 7 patients (0.7%), with all of them ending up having successful revascularization and uneventful recovery. Coronary perforations occurred in 9 patients (0.9%). Four of these patients required emergent pericardiocentesis due to tamponade. Five vessels were successfully treated with a covered stent (Jomed stent), and in 3 patients the perfo-
American Heart Journal October 2004
678 Zavala-Alarcon et al
Figure 1
Patient comorbidities.
Figure 2
Vessels intervened.
ration was treated with reversal of anticoagulation together with prolonged perfusion balloon inflation. One patient had a perforation involving the distal segment of the vessel and required treatment with coil embolization. Two of these patients with perforation had enzyme eleva-
tion postprocedure that was diagnostic of periprocedural myocardial infarction. Three patients (0.3%) required cardiopulmonary resuscitation and intubation during the interventional procedure with successful results and uneventful recovery.
American Heart Journal Volume 148, Number 4
Figure 3
Lesion types, ACC/AHA classification.
Postprocedure MI was diagnosed when the creatine phosphokinase-MB was ⬎3 times the baseline level; this occurred in 21 patients (2.1%), including the patients already described that had coronary perforations. Two patients (0.2%) developed a stroke after their PCI (within 48 hours) with no evidence of intracranial bleed on computed tomography (CT). Each patient required an extended hospital stay with residual neurologic sequelae. In 39 patients (3.9%), access site hematomas (⬎3 cm in size) were diagnosed that did not require blood transfusion or further intervention, with all of them recovering uneventfully. In 6 patients (0.6%), major access site complications occurred, including need for transfusion (5 patients), surgical revision (2 cases of femoral artery pseudoaneurysm and 1 case of brachial artery occlusion) or percutaneous intervention (1 to treat an occlusive dissection in an iliac artery treated with stent placement and 1 case with iliac perforation treated with a covered stent [Wallgraft]). Two patients (0.2%), developed progressive renal failure attributed to the procedure that stabilized with medical management not requiring dialysis. Periprocedural death (within 48 hours of the procedure) occurred in two patients (0.2%), with 11 inhospital deaths (1.1%). The deaths of 9 other patients during the same hospitalization when the PCI was performed were considered unrelated to the procedure; they occurred as the result of other multiple medical or surgical conditions. The 2 cases of periprocedural death were related to bleeding complications while on tirofiban, without evidence of vascular injury on emergent angiography. Of significant interest is the fact that out of the 1000 interventions performed, no case required emergency CABG surgery (Figure 4).
Discussion The early experience with PCI was characterized by frequent complications, including coronary dissection, acute recoil, coronary perforation, and coronary thrombosis.6 The early years demanded “surgical standby” for emergency CABG surgery, which was frequently required to salvage patients from these dreaded complications. The performance of PCI was predicated on the availability of on-site cardiac surgery.
Zavala-Alarcon et al 679
In many foreign countries, the formal requirement for on-site cardiac surgery for the performance of PCI has slowly changed. In the British Cardiac Society Guidelines, of 20,511 PCI procedures performed in the United Kingdom in 1996, 1382 (7%) were performed in 6 centers without on-site cardiac surgical capabilities.7 Emergency CABG within 24 hours was required in 1.5% of patients. Surgical backup, whether on-site or off-site, was recommended for all coronary angioplasty procedures.7 In Israel, a recent publication8 reports 11 years of experience of performing PCI without surgical support. In Canada, the Cardiac Care Network of Ontario9 has recommended to the Ontario Ministry of Health that pilot programs be set up in Ontario to perform coronary angioplasty (both primary and elective) at hospitals without on-site surgical backup. Increasing experience in PCI as well as several technical improvements, primarily the routine use of stents, has dramatically reduced the need for emergency surgical revascularization. The role of heart surgery has switched from the emergency treatment of the frequent complications of PCI to the timely revascularization of subjects not suitable for percutaneous interventions. Thus, the performance of PCI at centers without on-site surgical facilities is gaining widespread acceptance. Loubeyre et al2 reported a retrospective (1995) and prospective (1996) registry that analyzed the incidence, indication, and results of emergency CABG surgery performed within 24 hours of PCI in 68 and 57 centers, respectively, accounting for nearly half of all angioplasty procedures in France. Over the 2 years, 26,885 and 27,497 procedures were investigated, with a stenting rate of 46% and 64%, respectively. The observed need for emergency surgery was constantly low throughout this period (0.38% and 0.32%, respectively). Indications for surgery included complications directly due to PCI in 37% of cases in the 2-year period. Outcome remained poor, with inhospital mortality in 10% and 17% and myocardial infarction in 27% and 25% of cases, respectively. A comparison of the results in centers with and without surgical facilities showed no differences in outcome, despite a longer time to surgery (359 min ⫾ 406 min vs 170 min ⫾ 205 min, P ⫽ .0001) and a lower incidence of emergency surgery (0.25% versus 0.44%, P ⫽ .0001) in centers without on-site surgery backup. The French multicenter registry revealed an increase in the use of stents together with a dramatic decrease in the incidence of emergency CABG surgery (below 0.5%) following PCI. In the United States, Ting et al10 studied the safety and efficacy of performing low-risk elective and acute infarct PCI at a community hospital without cardiac surgical capability. Procedural success was achieved in 195 (99.5%) patients, with 1 (0.5%) inhospital death.
American Heart Journal October 2004
680 Zavala-Alarcon et al
Figure 4
Complications.
No patients required transfer to another facility for emergent cardiac surgery for a procedure-related complication. They conclude that low-risk elective and acute infarct PCI can be performed with safety and efficacy at a community hospital without cardiac surgical capability by following rigorous standards. The complications of PCI that can lead to emergency surgery are: 1) flow limiting dissection; 2) abrupt closure; 3) occlusion of a large side branch during the procedure, with an inability to restore patency percutaneously; and 4) coronary artery perforation. In recent years, there has been a steady decline in the frequency of dissections and abrupt closures. The explanations are multifactorial, but the use of coronary artery stents has been the most important factor.11 Glycoprotein IIb/IIIa receptor inhibitors also reduce the need for emergency CABG in patients undergoing PCI.12 In an analysis of pooled data from 2 trials (Evaluation of Platelet IIb/IIIa Inhibitor for Stenting and Evaluation of Percutaneous Transluminal Coronary Angioplasty to Improve Long-term Outcome With Abciximab Glycoprotein IIb/IIIa Blockade), the incidence of cardiac surgical procedures was 1.28% in patients receiving abciximab, which is substantially lower than the incidence of 2.17% in the placebo group (relative risk reduction 41%, P ⫽ .021).12 Coronary perforations, particularly if they are severe or occur in patients treated with glycoprotein IIb/IIIa inhibitors, may not respond to prolonged balloon inflation or pericardiocentesis and may require emergency CABG surgery, but this complication is rare.13 Use of a coronary stent covered with PTFE membrane reduces the need for CABG in such cases.14
The establishment of cardiac surgery programs for the sole purpose of supporting PCI is quite controversial. The surgical volume will most likely be insufficient to be cost-effective but also outcomes might be jeopardized. Immediate death rates (death during the hospital admission) with CABG surgery vary widely, from lows of 1% to highs approaching 15% and perhaps higher. Research from the United States demonstrates clearly that there is a volume effect. Centers and surgeons with higher volumes have lower immediate mortality. The volume effect persists even at relatively high levels, that is, ⬎650 procedures a year for a hospital and ⬎116 procedures a year for a physician. This fact strongly supports regulation to centralize CABG surgery facilities.15 A recent study16 showed how mortality decreased (P ⬍ .001) with increasing volume (3.6% in low [⬍500 cases], 3.0% in moderate [500 –1000 cases], and 2.0% in high [⬎1000 cases] volume hospitals). The impact of new technology, specifically the availability of drug-eluting stents, will clearly have an impact on CABG surgery volume. Surgical indications will be further reduced to the technical pitfalls of stenting (complex or tortuous anatomy, chronic occlusions, multiple tandem lesions). An important question is whether the availability of on-site cardiac surgery influences the interventionist in deciding for surgical referral against a more aggressive PCI approach to solve the complication. Results of emergency CABG surgery after PCI complications are poor even in hospitals with on-site cardiac surgery.2 In a recent review,17 emergency CABG surgery for failed PCI is still associated with important morbidity and
American Heart Journal Volume 148, Number 4
mortality. In 18,593 PCI procedures performed from 1992 through 2000, there was a need for emergency CABG surgery in 113 (0.61%) cases. The major indications were extensive dissection (n ⫽ 61, 54%), perforation/tamponade (n ⫽ 23, 20%), and recurrent acute closure (n ⫽ 23, 20%). Prevalence of emergency CABG surgery decreased from 1.5% of PCI cases in 1992 to 0.14% in 2000 (P ⬍ .001) In patients undergoing emergency CABG surgery, there were 17 (15%) inhospital deaths, 14 (12%) perioperative Q-wave myocardial infarctions, and 6 (5%) strokes. The experience and competency of the interventionist is clearly an important factor. There is clearly an association between institutional and individual procedural volumes and clinical outcome, including mortality.18 Current American College of Cardiology/American Heart Association (ACC/AHA) recommendations suggest that an individual operator should perform at least 75 cases annually to remain competent.1 Hamad et al19 studied the results of 781 PCI procedures performed at 1 institution by either high- (⬎100 procedures per year) or low-volume operators (⬍100 procedures per year) and concluded that low-volume operators had poorer outcomes when more complex lesions were involved. Another study20 involving 2350 PCIs performed by high- (⬎50/y) and low-volume operators (⬍50/y) at a single institution found differences in the rates of emergency CABG surgery (2.1% for high-volume, 3.9% for low-volume operators . Jollis et al21 studied 1992 Medicare discharge abstracts for 97,478 patients who had PCI performed by 6115 physicians. The rates for inhospital CABG surgery were 3.8%, 3.4%, and 2.6% for patients treated by physicians with an average volume of ⬍25, 25–50, and ⬎50 PCI procedures per year, respectively (P ⬍ .001). A study of the 1991 to 1994 New York State experience,22 with 62,670 patients treated by ⬎100 physicians, discovered significant differences in patients undergoing PCI performed by cardiologists with annual volumes ⬍75/year. These patients had a risk-adjusted mortality rate of 1.03%, compared with 0.90% for all patients, and a same-stay risk-adjusted CABG surgery rate of 3.95%, compared with 3.43% for all patients. Ellis et al23 analyzed databases from 5 high-volume centers involving 12,985 patients undergoing PCIs during 1993 to 1994 and also found a significant, inverse relation between operator volume and the combined end point of death, Q-wave myocardial infarction, or the need for emergency CABG surgery. The relationship of appropriate revascularization to the availability of PCI capability has been reported. Women, ethnic minorities, and uninsured persons receive fewer cardiac procedures than affluent white male patients do.24 Hospitals that provided on-site revascularization had higher use rates (76%) than hospitals that did not provide it (59%). In hospitals that did
Zavala-Alarcon et al 681
Figure 5
NMRI registry. Among the 1506 participating registry hospitals, 423 (28.1%) were classified as noninvasive, 380 (25.2%) as cathcapable, 112 (7.4%) as percutaneous coronary angiography-capable and 591 (39.2%) as CABG-capable. From Rogers et al.26
not provide on-site revascularization, uninsured patients were less likely to have revascularization recommended to them (52%). The availability of qualified hospitals and operators is the chief limitation to the widespread application of PCI in patients who require it. Approximately 840 community hospitals in the United States that have cardiac catheterization laboratories do not have cardiac surgery facilities.25 A report of the National Registry of Myocardial Infarction (NRMI-2) showed that among the 1506 participating registry hospitals, 423 (28.1%) were classified as noninvasive, 380 (25.2%) as catheterization-capable, 112 (7.4%) as percutaneous transluminal coronary angioplasty-capable, and 591 (39.2%) as CABG-capable (Figure 5).26 Many of these hospitals are staffed by experienced and active interventionalists. In view of the growing population in need of PCI and the decreasing role of CABG surgery to revascularize these patients, the established requirement to have on-site cardiac surgical capability has to be reviewed to evaluate whether PCI can be extended safely and effectively to these primary care hospitals. This paper reports for the first time in the United States the safety of performing elective, non selected, including high-risk cases of PCI in a hospital without cardiac surgery capability. Our experience is significant since it mimics the conditions present in many hospitals in this country, where experienced interventionalists are available and where diagnostic cardiac catheterization laboratories are underutilized due to the dogma of the requirement for surgical back-up. We believe that our results together with the vast experience in other countries supports a paradigm change that would increase the number of hospitals that can offer interventional cardiology procedures with a corresponding increase in the number of patients that would benefit.
American Heart Journal October 2004
682 Zavala-Alarcon et al
We suggest the following standards for the performance of elective and primary angioplasty at community hospitals without cardiac surgery: ● The operators must be experienced interventionalists who regularly perform elective intervention. ● The nursing and technical catheterization laboratory staff must be experienced in handling acutely ill patients and comfortable with interventional equipment. They must have acquired experience in dedicated angioplasty laboratories at a surgical center. They must participate in a 24hour 365-day call schedule. ● The catheterization laboratory itself must be well equipped, with optimal imaging systems, resuscitative equipment, and IABP support, and must be well stocked with a broad array of interventional equipment. ● The cardiac care unit nurses must be adept in hemodynamic monitoring and IABP management. ● The hospital administration must fully support the program and enable the fulfillment of the above institutional requirements. ● Formalized written protocols for immediate and efficient transfer of patients to the nearest cardiac surgical facility must be in place. ● The volume of yearly procedures performed by each operator should be high enough (according to ACC/AHA guidelines) to ensure continued competency. ● Primary intervention must be performed routinely as the treatment of choice around the clock for a large proportion of patients with acute myocardial infarction, to ensure streamlined care paths and increased case volumes. ● There must be an ongoing program of outcomes analysis and formalized periodic case review.
Limitations This is a single-center experience. Conditions required to establish a safe elective PCI program might be difficult to meet at other hospitals. We believe, however, that results similar to ours can be achieved by cardiologists and institutions that establish programs that adopt rigorous standards such as those proposed. Our data were collected retrospectively, although complications were followed on a daily basis by an experienced nurse with expertise in quality assurance programs. The hospital quality assurance committee evaluated each complicated case during monthly meetings. A team of independent consultants was assigned by the hospital administration to evaluate the appropriateness of the interventional program. Their findings supported the continuation of the program. We thank the hospital administration at Maricopa Medical Center without whose enthusiastic support this work would not have been possible. The excellent work of Ellen Horton, RN, in data collection and Curt Bay, PhD, in statistical analysis is paramount to the publication of our work. We particularly wish to
acknowledge the invaluable contributions of the catheterization laboratory team, Jeff Weddle, RN, Ann Kelly, RN, Kelly Johansen, RN, and David Pigg, RT, whose dedicated service and commitment to an intensive work schedule were integral to the success of our program. Special mention must be made of our cardiovascular technician, Vincent Romero, who contributed his experience and skills to the excellent outcomes achieved.
References 1. Smith SC Jr, Dove JT, Jacobs AK, et al. ACC/AHA guidelines for percutaneous coronary intervention (revision of the 1993 PTCA guidelines)— executive summary: a report of the American College of Cardiology/American Heart Association task force on practice guidelines (Committee to revise the 1993 guidelines for percutaneous transluminal coronary angioplasty) endorsed by the Society for Cardiac Angiography and Interventions. Circulation 2001;103: 3019 – 41. 2. Loubeyre C, Morice MC, Berzin B, et al. Emergency coronary artery bypass surgery following coronary angioplasty and stenting: results of a French multicenter registry. Catheter Cardiovasc Interv 1999;47:441– 8. 3. Karvouni E, Katritsis DG, Ioannidis JP. Intravenous glycoprotein IIb/IIIa receptor antagonists reduce mortality after percutaneous coronary interventions. J Am Coll Cardiol 2003;41:26 –32. 4. McGrath PD, Malenka DJ, Wennberg DE, et al. Changing outcomes in percutaneous coronary interventions: a study of 34,752 procedures in northern New England, 1990 to 1997. J Am Coll Cardiol 1999;34:674 – 80. 5. Tamburino C, Russo G, Nicosia A, et al. Prophylactic abciximab in elective coronary stenting: results of a randomized trial. J Invasive Cardiol 2002;2:72–9. 6. Holmes DR Jr, Holubkov R, Vlietstra RE, et al. Comparison of complications during percutaneous transluminal coronary angioplasty from 1977 to 1981 and from 1985 to 1986: the National Heart, Lung, and Blood Institute Percutaneous Transluminal Coronary Angioplasty Registry. J Am Coll Cardiol 1988;12:1149 –55. 7. Joint Working Group on Coronary Angioplasty of the British Cardiac Society and British Cardiovascular Intervention Society. Coronary angioplasty: guidelines for good practice and training. Heart 2000;83:224 –35. 8. Turgeman Y, Atar S, Suleiman K, et al. Diagnostic and therapeutic percutaneous cardiac interventions without on-site surgical backup—review of 11 years experience. Isr Med Assoc J 2003;5:89 – 93. 9. Cardiac Care Network of Ontario. Available at: http://www.ccn. on.ca. Accessed February 5, 2002. 10. Ting HH, Garratt KN, Tiede DJ, et al. (2000) Percutaneous coronary intervention at two community hospitals without on-site cardiac surgical services supported with telemedicine [abstract]. Circulation 2000;102(Suppl II):II735. 11. Holmes DR Jr, Hirshfeld J Jr, Faxon D, et al. ACC expert consensus document on coronary artery stents: document of the American College of Cardiology. J Am Coll Cardiol 1998;32:1471– 82. 12. Lincoff AM, LeNarz LA, Despotis GJ, et al. Abciximab and bleeding during coronary surgery: results from the EPILOG and EPISTENT trials. Ann Thorac Surg 2000;70:516 –26.
American Heart Journal Volume 148, Number 4
13. Ellis SG, Ajluni S, Arnold AZ, et al. Increased coronary perforation in the new device era: incidence, classification, management, and outcome. Circulation 1994;90:2725–30. 14. Briguori C, Nishida T, Anzuini A, et al. Emergency polytetrafluoroethylene-covered stent implantation to treat coronary ruptures. Circulation 2000;102:3028 –31. 15. Banta D, Bos M. The relation between quantity and quality with coronary artery bypass graft (CABG) surgery. Health Policy 1991; 18:1–10. 16. Rosenthal GE, Vaughan Sarrazin M, et al. In-hospital mortality following coronary artery bypass graft surgery in Veterans Health Administration and private sector hospitals. Med Care 2003;41: 522–35. 17. Seshadri N, Whitlow PL, Acharya N, et al. Emergency coronary artery bypass surgery in the contemporary percutaneous coronary intervention era. Circulation 2002;106:2346 –50. 18. McGrath PD, Wennberg DE, Dickens JD. Relation between operator and hospital volume and outcomes following percutaneous coronary interventions in the era of the coronary stent [Interventional Cardiology Abstracts]. ACC Curr J R 2001;10(4). 19. Hamad N, Pichard AD, Lyle HRP, et al. Results of percutaneous transluminal coronary angioplasty by multiple, relatively low frequency operators: 1986 –1987 experience. Am J Cardiol 1998; 61:1229 –31.
Zavala-Alarcon et al 683
20. Shook TL, Sun GW, Burstein S, et al. Comparison of percutaneous transluminal coronary angioplasty outcome and hospital costs for low-volume and high-volume operators. Am J Cardiol 1996;77: 331–36. 21. Jollis JG, Peterson ED, Nelson CL, et al. Relationship between physician and hospital coronary angioplasty volume and outcome in elderly patients. Circulation 1997;96:2485–91. 22. Hannan EL, Racz M, Ryan TJ, et al. Coronary angioplasty volume– outcome relationships for hospitals and cardiologists. JAMA 1997; 279:892– 8. 23. Ellis SG, Weintraub W, Holmes D, et al. Relation of operator volume and experience to procedural outcome of percutaneous coronary revascularization at hospitals with high interventional volumes. Circulation 1997;96:2479 – 84. 24. Leape LL, Hilborne LH, Bell R, et al. Underuse of cardiac procedures: do women, ethnic minorities, and the uninsured fail to receive needed revascularization? Ann Intern Med 1999;130:183–92. 25. Directory of Cardiac Catheterization Laboratories in the United States. 4th ed. Raleigh (NC): The Society for Cardiac Angiography and Interventions; 1997. 26. Rogers WJ, Canto JG, Barron HV, et al. Investigators in the National Registry of Myocardial Infarction Treatment and outcome of myocardial infarction in hospitals with and without invasive capability. J Am Coll Cardiol 2000;35:371–9.