While great advances continue to be made in the technology and pharmacology of coronary intervention, much more work needs to be done to improve the delivery of PCI to a greater proportion of patients with ACS, now that the superiority of the interven-tional approach is being clearly established. According to Medicare data in Michigan, 60% of patients with AMI present to hospitals that do not have cardiac surgical programs (1). Nearly all of these hospitals do not have the capability to provide PCI.
The solution to this problem of improving the access to early PCI for patients with AMI and other high risk ACS requires three interdependent approaches: (i) the development of new PCI programs at those nonsurgical hospitals that can meet rigorous requirements, such as those that we have advocated (Tables 2 and 3) (30); (ii) the development of systems and transfer agreements at the local hospital level to encourage more frequent and earlier transfer of more patients to emergency intervention centers; and (iii) the establishment of guidelines, policies, and protocols to enable and encourage the pre-hospital ambulance triage of patients with suspected AMI to emergency intervention centers that have 24-h, 365-d PCI capability (analogous to trauma centers).
Because the transfer of ever-increasing numbers of patients with high-risk ACS to tertiary centers, which currently provide PCI, could quickly overload their capacity, even
Operator, Institutional, and Angiographic Criteria for Primary PCI Programs at Hospitals without On-Site Cardiac Surgery (30)
1. The operators must be experienced high-vol interventionalists who regularly perform elective intervention.
2. The nursing and technical CCL staff must be experienced in handling acutely ill patients and comfortable with interventional equipment. They must have acquired experience in dedicated interventional laboratories. They participate in a 24-h, 7-d/wk call schedule.
3. The CCL itself must be well equipped, with optimal imaging systems, resuscitative equipment, IABP support, and must be well stocked with a broad array of interventional equipment.
4. The CCU nurses must be adept in the management of acutely ill cardiac patients, including invasive hemodynamic monitoring and IABP management.
5. The hospital administration must fully support the program and enable the fulfillment of the above institutional requirements.
6. Formalized written protocols must be in place for immediate and efficient transfer of patients to the nearest cardiac surgical facility.
7. Primary PCI must be performed routinely as the treatment of choice around the clock for a large proportion of patients with AMI, to ensure streamlined care paths and increased case vol. The institution should expect to perform 3 to 4 primary PCI procedures/mo.
8. Clinical and angiographic selection criteria for the performance of primary PCI and for transfer for emergency CABG must be rigorous (Table 4).
9. There must be an ongoing program of outcomes analysis and formalized periodic case review.
AMI, acute myocardial infarction; CABG, coronary artery bypass graft; CCL, cardiac catheterization laboratory; CCU, cardiac care unit; IABP, intra-aortic balloon pump; PCI, percutaneous coronary intervention.
Adapted from ref. 30.
Selection for Primary PCI and Emergency Aortocoronary Bypass Surgery at Hospitals without
On-Site Cardiac Surgery (30)
Avoid intervention in hemodynamically stable patients with:
• Significant (>60%) stenosis of an unprotected left main coronary artery upstream from an acute occlusion in the left coronary system that might be disrupted by the angioplasty catheter.
• Extremely long or angulated infarct-related lesions with TIMI grade 3 flow.
• Infarct-related lesions with TIMI grade 3 flow in stable patients with three-vessel disease
• Infarct-related lesions of small or secondary vessels.
• Lesions in other than the infarct artery.
Transfer for emergent aortocoronary bypass surgery patients with:
• High-grade residual left main or multivessel coronary disease and clinical or hemodynamic instability:
—After angioplasty of occluded vessels. —Preferably with intra-aortic balloon pump support.
PCI, percutaneous coronary intervention; TIMI, Thrombolysis in Myocardial Infarction. Adapted from ref. 30.
if all of them did provide primary PCI as first-line therapy for AMI, the second and third approaches above will ultimately depend on the development of more interventional programs at more community hospitals. The need for more interventional facilities can be projected to increase even further in the near future, with the aging of the baby boomers (42) and with the increased application of PCI to more patients. This increasing need for coronary intervention may well outstrip the need for more cardiac surgery facilities. Thus, solutions 2 and 3 above will ultimately depend, in part, on solution 1, the uncoupling of PCI programs from cardiac surgery programs.
Though there is an emerging practice in some hospitals in the US to provide primary, urgent, and even elective PCI with off-site surgical backup, there are important regulatory barriers that discourage this practice in many states. It is to be hoped that the new American College of Cardiology/American Heart Association (ACC/AHA) guidelines for PCI will help to discourage these regulatory barriers. The new guidelines state that the superiority and greater applicability of primary PCI for the treatment of AMI has raised the question of whether primary PCI should be performed at institutions . . . [without] on-site cardiac surgery (43). The guidelines recommend primary PCI at hospitals with off-site cardiac surgical backup with a Class IIb indication (usefulness/efficacy less well-established by evidence/opinion), provided that >36 procedures per year are performed at such hospitals by higher-volume interventionals within 30-90 min of admission and that a proven plan for rapid access to a cardiac surgical center is in place. These guidelines also include tables listing further operator, institutional, and patient selection criteria for the performance of PCI and emergency coronary bypass surgery at such hospitals, based on those that we originally proposed (Tables 2 and 3). Thus they affirm that, when appropriate standards are met, the provision of primary PCI at hospitals with off-site cardiac surgical backup is a reasonable treatment alternative. These guidelines, while still discouraging the performance of nonemergent PCI at non-surgical hospitals, do add in a discussion of this issue that, "As with many dynamic areas in interventional cardiology, these recommendations may be subject to revision as clinical data and experience increase."
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