Portal de Periódicos da CAPES

The current status and future direction of percutaneous coronary intervention without on‐site surgical backup: An expert consensus document from the Society for Cardiovascular Angiography and Interventions

2007; Wiley; Volume: 69; Issue: 4 Linguagem: Inglês

10.1002/ccd.21097

1522-726X

Gregory Dehmer, James C. Blankenship, Thomas P. Wharton, Ashok Seth, Douglass A. Morrison, Carlo Di Mario, David C. Muller, Mirle A. Kellett, Barry F. Uretsky,

Cardiac, Anesthesia and Surgical Outcomes

The Society for Cardiovascular Angiography and Interventions (SCAI) coauthored and cosponsored with the American College of Cardiology (ACC) and the American Heart Association (AHA) the percutaneous coronary intervention (PCI) guidelines update, released in November 2005 [1]. This guideline update continued to designate elective PCI without on-site surgery as a Class III indication, and primary PCI for ST-segment elevation myocardial infarction (STEMI) as a class IIb indication in the absence of on-site surgery. The performance of PCI without on-site surgical backup is currently the subject of debate. Although providing the highest quality of care and best outcomes to patients should always be the primary goal, debate on this topic has the potential to supersede quality of patient care issues. Within this context, SCAI developed this Expert Consensus document to determine the current status of PCI without on-site surgery not only in the United States, but globally, and make recommendations regarding the performance of PCI in this circumstance. The focus of this document is to provide a structure that provides the highest quality care to patients undergoing PCI in any circumstance. Over the past 20 years, the use and indications for PCI have greatly expanded. It is now well-recognized that PCI is safer and the need for urgent coronary artery bypass graft (CABG) surgery greatly reduced [2]. Primary PCI, when available, has eclipsed fibrinolytic therapy for reperfusion in the treatment of STEMI [3], but is adversely affected by time delays in initiating the PCI procedure [4]. Studies examining patient transport to PCI hospitals have shown suboptimal initial door-to-balloon times, especially in the United States [5]. Efforts to provide primary PCI services locally at community hospitals without on-site cardiac surgery have developed and demonstrate outcomes comparable to facilities that have on-site cardiac surgery [6]. Because it is difficult to sustain a PCI program solely on STEMI patients, elective PCIs are also being performed at facilities without on-site surgery [7], enhancing the debate regarding PCI without on-site surgery. Data on the prevalence of PCI performed without on-site surgical backup in the United States are not easily found and are changing rapidly. Data gathered from several sources and believed accurate as of July 2006 indicate primary PCI programs without on-site surgical backup exist in all but 10 states (Alaska, Arkansas, Delaware, Georgia, Mississippi, North Dakota, Rhode Island, South Dakota, Vermont, and Wyoming) plus the District of Columbia. Facilities performing both primary and elective PCI without on-site surgery currently exist in 28 states. A large (n = 18,000) randomized trial of elective PCI without on-site surgery (The Atlantic Cardiovascular Patient Outcomes Research Team Elective Angioplasty Study) is currently enrolling patients and includes facilities in several states where elective PCI without on-site backup has been prohibited. The exact number of patients receiving PCI at facilities without on-site surgery is unknown. Data from facilities reporting to the CathPCI Registry™ of the ACC-National Cardiovascular Data Registry (ACC-NCDR®) show an increase in the number of both primary and elective PCIs performed without on-site surgical backup [8]. In 2005, 75 of the 463 facilities reporting to the ACC-NCDR were performing PCI without on-site surgical backup. PCI without on-site surgical backup is being performed in 35 of 39 (90%) countries responding to requests for information and appears to be increasing. For example, 7% of PCI procedures performed in the United Kingdom in 1996 were at facilities without on-site cardiac surgery. By 2004, this increased to 15% with 26% of the PCI centers in the United Kingdom operating without on-site cardiac surgery. In the 2005 update of this guideline, primary PCI without on-site surgical backup remained a Class IIb indication, and elective PCI without on-site surgery remained a Class III indication. Many other programmatic recommendations were made [1]. In contrast to the ACC/AHA/SCAI guidelines, the 2005 European Society of Cardiology (ESC) guidelines do not comment on PCI without on-site cardiac surgery or issues related to institutional or operator competency [9]. The British Cardiac Society and British Cardiovascular Intervention Society (BCIS) guideline, published in 2005, acknowledges and approves PCI without on-site surgical backup and emphasizes a common standard applied across facilities with and without on-site surgical backup so as to avoid two levels of service provision [10]. The only German guidelines found were published in 1987 [11] and thus may not be relevant today. However, there is substantial evidence that PCI without on-site surgical backup is widely performed in Germany. Policy statements on support facilities and on the performance of coronary angiography and PCI at rural sites in Australia and New Zealand were published (on-line) in 2003 and 2005, respectively [12, 13]. The Cardiac Society of Australia and New Zealand (CSANZ) guidelines state that PCI is preferably performed in hospitals with on-site surgical support, but acknowledge that the requirements for on-site cardiac surgical facilities may be omitted in certain circumstances, and that appropriately trained individuals can perform coronary interventional procedures safely in hospitals without on-site surgical backup. Furthermore, these documents acknowledge that rural patients have reduced access to diagnostic angiography and interventional procedures and further state that providing these services as close to the patient's place of residence as possible facilitates equity of access, which should result in improved quality of care. Published in 1999 [14], these guidelines are specific for PCI at hospitals without on-site cardiac surgery. PCI performance without on-site cardiac surgery is not prohibited, provided a program meets certain requirements. Guidelines from the Brazilian Society of Cardiac Hemodynamics and Intervention (Sociedade Brasileira de Hemodinâmica e Cardiologia Intervencionista) [15] were published in 2003. They use a scheme similar to the ACC/AHA/SCAI guidelines [1] and classify elective PCI without on-site surgical backup as Class III. Primary PCI for STEMI in the absence of on-site surgery is a Class IIa indication; their guidelines do not have a IIb category. Published in 2003, these guidelines acknowledge the increasing safety and diminishing risk of PCI but conclude that "the current standard practice for elective PCI remains the presence of on-site surgical standby" [16]. There are over 30 published papers or abstracts reporting PCI results without on-site surgical backup. All published data for both primary and elective PCI were derived from retrospective reviews or registries, and thus are subject to unintentional bias and other methodological concerns. These are summarized and referenced in the on-line version of this document. These studies span a time period from 1990 to 2006, and thus incorporate changing treatment paradigms, including fibrinolytic therapy before PCI, glycoprotein IIb/IIIa inhibitors, and coronary artery stents. The total patient number within some of these reports is not easily derived because the studies listed are expanding experiences within the same registry; thus, simple aggregation of outcome data is not appropriate or meaningful. The more recent reports show that both primary and elective PCI without on-site surgical backup are performed with a high success rate, low in-hospital mortality rate, and a low rate of urgent cardiac surgery. Although no randomized or controlled studies exist and despite the current ACC/AHA/SCAI guideline recommendation, PCI without on-site surgery is being performed in many states and is accepted in many countries throughout the world. Moreover, data from many countries, including the United States, indicate that the use of PCI without on-site surgery is growing [8]. The purpose of this document is neither to challenge the ACC/AHA/SCAI guideline recommendations nor to support PCI without on-site surgery backup. However, with the reality that PCI without on-site surgery is growing, it is both appropriate and necessary to define the best standards of practice such that facilities and physicians operate within the highest possible quality standards. Only operators with complication rates and outcomes equivalent or superior to national benchmarks should perform PCI procedures with or without on-site surgery. The operator also must actively participate in a facility's quality improvement program. In addition to involvement in local continuous quality improvement efforts, participation in a national data registry if available and appropriate continuing medical education is mandatory. A proven record of satisfactory outcomes is of greater importance than simply meeting an arbitrary case volume requirement. However, operators must have sufficient prior experience to allow assessment of their judgment and quality. The initial operators at a facility without on-site backup should not begin performing PCI in such facilities until they have a lifetime experience of >500 PCIs as primary operator after completing fellowship. Interventional cardiologists joining those already engaged in PCI without on-site surgery with <500 cases of lifetime experience should be mentored and monitored by existing physicians until it is determined and certified formally by that hospital that their skills and judgment are excellent and outcomes equivalent or superior to the national benchmarks. Operators performing PCI without on-site surgery should perform ≥100 total PCIs per year, including ≥18 primary PCIs per year. These numbers exceed those currently recommended in the ACC/AHA/SCAI guidelines to reflect the opinion of this writing group that a greater experience level is appropriate for PCI in this setting. In the United States, board certification in interventional cardiology by the American Board of Internal Medicine is strongly recommended for all physicians performing PCI. It is essential that all support personnel have adequate education regarding the management of PCI patients before, during, and after the procedure. This knowledge should include potential procedural complications and their management and the drug therapies used in PCI patients (Table I). Meticulous clinical and angiographic selection criteria for PCI (Tables II and III). Facilities performing both primary and elective procedures without on-site surgery should perform a minimum of 200 PCI/year. Programs with <200 PCI/year should be reviewed on an individual basis. They should remain open only if they are in geographically isolated or under-served areas and their performance metrics are equivalent to accepted benchmarks. We recommend that each country or state review this issue, and establish an absolute minimum annual case volume below which a PCI program must close under any circumstance. In the United States, this minimum should be 150 PCI/year for a program offering both primary and elective PCIs and this must include a minimum of 36 primary PCI/year. Programs offering only primary PCIs must perform a minimum of 36 primary PCIs/year to remain operational. At the present time in the United States, there is no justification for a PCI program without on-site surgery to perform only elective procedures or not provide availability to primary PCI 24 hr/day, but such a situation may exist in other countries and be appropriate. New programs should have 2 years to reach the absolute minimum volume, but after that programs failing to reach this volume for 2 consecutive years should not remain open under any circumstance. Rigorous clinical and angiographic selection criteria are essential for programs performing PCI without on-site surgery. Since the clinical situation and risk-to-benefit ratio are different for primary versus elective PCI, different criteria and standards should apply (Table II). In elective PCI without on-site surgery, it is necessary to assess not only the likelihood of PCI failure, but also the potential patient risk if complications occur since it is possible to have a low-risk lesion in a high-risk patient and vice versa. It is important to consider both the patient and lesion risk when developing criteria for selection of appropriate patients for treatment in facilities without on-site surgery (Table III). A close alliance and cross-communication with cardiovascular surgeons with formalized agreements and periodically tested protocols for the emergency transfer of patients are essential (Table IV). Interventional cardiologists and cardiac surgeons must be actively involved in the program with attendance at regularly scheduled cardiac catheterization conferences and participation in risk management activities. In hospitals with on-site surgery, it is no longer standard for a surgical suite to be held open awaiting the completion of a PCI. Because the need for urgent surgery is so infrequent, there are no current data regarding the actual time required to transport a patient to the operating room and initiate cardiopulmonary bypass should the need arise. Should a patient undergoing PCI at a facility without on-site surgery develop a complication requiring urgent transfer for surgery, it is unclear whether or by how much the facility-to-facility transport would add an additional delay in the current practice environment where operating rooms are not held open at on-site facilities. Minimizing the time to the initiation of cardiopulmonary bypass is the goal in this situation and more likely is feasible with on-site cardiac surgery if that surgery is immediately available. There is no acknowledged goal with supporting data similar to a door-to-balloon time for the initiation of cardiopulmonary bypass in this situation, but this should always be accomplished as rapidly as possible, with the goal of 500 PCIs as primary operator after completing fellowship. Only operators with complication rates and outcomes equivalent or superior to national benchmarks should perform PCI procedures. Independent program oversight should occur either within the context of a local facility's quality assurance program or through an independent government or external agency. Any program failing to perform adequately should close. Further data collection and analysis should be done to more completely understand the role of PCI without on-site surgical backup as a strategy for the delivery of care. The full-length version of this article can be found on the Catheterization and Cardiovascular Interventions website (http://www.mrw.interscience.wiley.com/suppmat/1522-1946-suppmat-index.html) and on the SCAI website at www.scai.org. Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.