2012 American college of cardiology foundation/society for cardiovascular angiography and interventions expert consensus document on cardiac catheterization laboratory standards update: American college of cardiology foundation task force on expert consensus documents society of thoracic surgeons society for vascular medicine

Appendix 1. Author Relationships With Industry and Other Entities (Relevant(—2012 ACCF/SCAI Expert Consensus Document on Cardiac Catheterization Laboratory Standards Update This document has been developed as an expert consensus document by the American College of Cardiology Foundation (ACCF) and the Society for Cardiovascular Angiography and Interventions (SCAI), in collaboration with the Society of Thoracic Surgeons (STS) and Society for Vascular Medicine (SVM). Expert consensus documents are intended to inform practitioners, payers, and other interested parties of the opinion of ACCF and document cosponsors concerning evolving areas of clinical practice and/or technologies that are widely available or new to the practice community. Topics chosen for coverage by this ECD are so designed because the evidence base, the experience with technology, and/or clinical practice are not considered sufficiently well developed to be evaluated by the formal ACCF/American Heart Association (AHA) Practice Guidelines process. Often the topic is the subject of considerable ongoing investigation. Thus, the reader should view the ECD as the best attempt of the ACCF and document cosponsors to inform and guide clinical practice in areas where rigorous evidence may not yet be available or evidence to date is not widely applied to clinical practice. When feasible, ECDs include indications or contraindications. Some topics covered by ECDs will be addressed subsequently by the ACCF/AHA Practice Guidelines Committee. The ACCF Task Force on Clinical Expert Consensus Documents (TF CECD) makes every effort to avoid any actual or potential conflicts of interest that might arise as a result of an outside relationship or personal interest of a member of the writing panel. Specifically, all members of the writing panel are asked to provide disclosure statements of all such relationships that might be perceived as relevant to the writing effort. This information is documented in a table, reviewed by the parent task force before final writing committee selections are made, reviewed by the writing committee in conjunction with each conference call and/or meeting of the group, updated as changes occur throughout the document development process, and ultimately published as an appendix to the document. External peer reviewers of the document are asked to provide this information as well. The disclosure tables for writing committee members and peer reviewers are listed in Appendices 1 and 2, respectively, of this document. Additionally, in the spirit of complete transparency, writing committee members' comprehensive disclosure information—including relationships with industry and other entities that do not pertain to this document—is available online. Disclosure information for members of the ACCF TF CECD—as the oversight group for this document development process—is also available online. The work of the writing committee was supported exclusively by the ACCF without commercial support. Writing committee members volunteered their time to this effort. Meetings and/or conference calls of the writing committee were confidential and attended only by committee members. The last expert consensus document on cardiac catheterization laboratory standards was published in 2001 (1). Since then, many changes have occurred as the setting has evolved from being primarily diagnostic based into a therapeutic environment. Technology has changed both the imaging and reporting systems. The lower risk of invasive procedures has seen the expansion of cardiac catheterization laboratories to sites without onsite cardiovascular surgery backup and even to community hospitals where primary percutaneous coronary intervention (PCI) is now being performed. This has increased the importance of quality assurance (QA) and quality improvement (QI) initiatives. At the same time, the laboratory has become a multipurpose suite with both diagnostic procedures to investigate pulmonary hypertension and coronary flow and with therapeutic procedures that now include intervention into the cerebral and peripheral vascular systems as well as in structural heart disease. These new procedures have impacted both the adult and pediatric catheterization laboratories. The approaches now available allow for the treatment of even very complex heart disease and have led to the development of hybrid cardiac catheterization laboratories where a team of physicians (including invasive cardiologists, cardiovascular surgeons, noninvasive cardiologists, and anesthesiologists) is required. Despite a growth in procedural sites and in procedural capabilities in the cardiac catheterization laboratory, the total number of coronary interventional procedures has steadily declined over the last few years. Full-service hospitals should provide, not only cardiovascular surgery, but also cardiovascular anesthesia and consulting services in vascular, nephrology, neurology, and hematology. Advanced imaging and mechanical support services should also be available. Not every hospital with onsite cardiovascular surgery should be offering all services unless the expertise is available to evaluate, treat, and handle any potential complications that occur. Patients requiring highly specialized procedures or pediatric procedures should have studies only in facilities with the medical expertise and equipment to perform these procedures at the highest level. Despite prior guidelines that suggest limitations to the expansion of cardiac catheterization without onsite surgical backup, the number of these sites has increased dramatically over the last decade. The Certificate of Need (CON) regulatory programs have had little impact on this expansion. Whether quality and outcomes are similar to hospitals with onsite cardiovascular surgery remains uncertain. The actual number of laboratories without surgical backup is difficult to confirm, but most estimates suggest it is around 25% to 35% of all laboratories in the United States. Because of fixed costs to maintain these facilities, costs and charges per patient at these sites may actually be higher than in facilities with onsite surgery. The remarkably low risk now associated with diagnostic cardiac catheterization suggests that only a few cardiovascular patients cannot safely undergo procedures in these laboratories. The 2001 ACC/SCAI consensus document suggests limiting diagnostic procedures in laboratories without cardiovascular surgical backup to the very lowest-risk patients; the current document lifts almost all these restrictions. Limitations related to age, congestive heart failure (CHF) status, the severity in stress test abnormalities, left ventricular (LV) function, and the presence of valve disease have all been removed. It is still recommended that patients with pulmonary edema due to ischemia, patients with complex congenital heart disease, and pediatric patients still be treated only in full-service facilities. Certain therapeutic procedures should still be done only in facilities with cardiovascular surgical backup. These include therapeutic procedures in adult congenital heart disease and pediatrics. It is generally believed that elective and primary PCI are permissible in sites without cardiovascular surgery, if there is strict adherence to national guidelines. In particular, there must be a documented working relationship with a larger facility with cardiovascular surgical services and an emergency transportation system operative. The document outlines the current guidelines where this is acceptable. The committee also believes that it is the responsibility of any facility performing coronary intervention without cardiovascular surgical backup to document that all national risk stratification and medication guidelines are being followed. In addition, a QA/QI system must be operative and active, and, if an ST-elevation myocardial infarction (STEMI) program is in place, the laboratory should be operational 24 hours a day, 7 days a week. Any national volume guidelines must also be strictly followed. The modern cardiac catheterization laboratory is a complex, highly sophisticated medical and radiological facility where patients with both chronic-stable and life-threatening illnesses are evaluated. 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This committee that there is volume for diagnostic catheterization that be supported and to the to the procedures are of the highest The interventional procedural volume of per has become an and have addressed this in relationships and/or and outcomes have been in many have to these the relationship volume and outcomes is complex, and many are in laboratories to the is the that many interventional do not perform procedures each Some perform PCI primarily and are at the or the of and are or a practice. Some perform procedures at facilities, and the for such are The for primary PCI are difficult to because of the low being performed. This committee believes that it is for all primary to be evaluated by the of to in primary PCI should be to these The guidelines for the of both elective and primary PCI in a facility without cardiovascular surgical backup are also studies and of available both suggest these procedures be done safely restrictions. The volume in this setting will be of the Writing to Update the Clinical on Cardiac Because these patients are at highest risk for national guidelines for the in the setting of an must be strictly followed. 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Because of the in patient most are to Often the or to in noninvasive of all pediatric are therapeutic and not number of procedures are in congenital heart disease as and are not to procedures that might also be in adult congenital patients include and in pulmonary and vascular of a ventricular pulmonary or valve and a of procedures are where may be of the left heart patient with the pediatric should have a for all of the laboratory similar to the adult physicians should be in and at in pediatric may be where a be but this should not be practice. The pediatric is from to years. 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It is a sophisticated where a in from a diagnostic laboratory to a therapeutic is the risk of both diagnostic and interventional procedures has there has been in the of patients may safely have procedures in both and in laboratories without cardiovascular surgical backup. 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