Guidelines for primary and elective PCI WITHOUT surgery back-up & the related guidelines for rescue PCI George D. Dangas, MD, PhD, FACCProfessor of Medicine (Cardiovascular Disease) Mount Sinai Medical Center New York, NY
James B McClurken, MD, FACC, FCCP, FACS, FESC Director of Thoracic Surgery The Heart Institute, Doylestown Hospital, PA Professor of Cardiothoracic Surgery Temple University Hospital
Disclosures - McClurkenI am a Cardiothoracic Surgeon employed by the Village Improvement Association of Doylestown Hospital, Doylestown, PA.I am co-author or reviewer for some of the ACCF/AHA … guidelines relevant to this topic.I have vivid recall of the early PTCA/PCI era!
Status of Percutaneous Coronary Intervention without On-site Cardiac Surgical Back-up in the US Gregory J Dehmer US Cardiology, 2009;6(1):69-74
PCI in Hospitals Without On-Site Surgical Backup: ACC/AHA/SCAI Guideline 2012CLASS IIa (Level of Evidence: B)1.Primary PCI is reasonable in hospitals without on-site cardiac surgery, provided thatappropriate planning for program development has been accomplished.CLASS IIb (Level of Evidence: B)1.Elective PCI might be considered in hospitals without on-site cardiac surgery,provided that appropriate planning for program development has been accomplishedand rigorous clinical and angiographic criteria are used for proper patient selection. (Level of Evidence: B)CLASS III: HARM (Level of Evidence: C)1.Primary or elective PCI should not be performed in hospitals without on-site cardiacsurgery capabilities without a proven plan for rapid transport to a cardiac surgeryoperating room in a nearby hospital or without appropriate hemodynamic supportcapability for transfer. Levine GN et.al. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention. Catheter Cardiovasc Interv. 2012 Feb 15;79(3):453-95.
PCI w/o Onsite CABG Back-up• Must have (part 1): – Periodic MD/NP/RN meetings to review complications • ? Outside participation (from CABG affiliated facility) – Periodic MD/NP/RN meetings to review case selection implications and appropriateness • ? Outside participation (from CABG affiliated facility) – Written protocol for criteria for onsite PCI performance per clinical syndrome (STEMI, ACS, stable) – Written protocol for pharmacology (admission to cath lab) per clinical syndrome
PCI w/o Onsite CABG Back-up• Must have (part 2): – Periodic meetings (NP/PA/RN) to review equipment and set-up – Written protocol for criteria for onsite use of hemodynamic support (cath lab, CCU, transfer) – Written protocol for transfer notification, approval process and fast completion • Transfer to which hospital? • Transfer to which doctor? • Transfer on what meds or support devices?
PCI (Primary & Elective) without Surgical Back-up Policy Guidance through Regulation or Legislation, AHA Advocacy Department; March 7, 2012 • States should require all PCI programs without surgical back-up to participate in programs like the Action Registry-Get With The Guidelines (AR-G), National Cardiovascular Data Registry (NCDR) or the Atlantic Cardiovascular Patient Outcomes Research Team (CPORT) to monitor their quality and outcomes, allowing program leaders to show their commitment to quality by subjecting their program performance to independent peer review. • The programs should adhere to strict patient-selection criteria (e.g. exclusion of patients with EF < 30%, unprotected Left Main intervention, intervention on last conduit to the heart).
PCI (Primary & Elective) without Surgical Back-up Policy Guidance through Regulation or Legislation, AHA Advocacy Department; March 7, 2012 • Have an annual institutional PCI volume of at least 200 to 400 cases. • Should include only AHA/ACC-qualified operators who meet standards for training and competency. • Should demonstrate appropriate planning for program development and should complete both a primary PCI development program and an elective PCI development program. Program development to include routine care process and case selection review. • Agree to develop and maintain a quality and error management program.
PCI (Primary & Elective) without Surgical Back-up Policy Guidance through Regulation or Legislation, AHA Advocacy Department; March 7, 2012 • Perform primary PCI 24/7. • Develop and maintain necessary agreements with a tertiary facility (which must agree to accept emergent and non-emergent transfers for additional medical care, cardiac surgery or intervention). • Develop and sustain agreements with an ambulance service capable of advanced life support and IABP transfer that guarantees a 30- minute-or-less response time.
Developing a Network• Thus far we have presented the necessity of the PCI hospital w/o CABG back-up to belong to an affiliation network with CABG-able facilities.• PCI case number is a key criterion.• An additional source of PCI cases can be derived from another network: – PCI site is the center – Its non-PCI hospital affiliates participate• The guidelines support Rescue PCI transfers after lytics• New data support Routine Transfer
PCI in non SOS Hospitals 1 year follow-up[2 hospitals in demonstration project in PA] Alfred A. Bove, MD PhD Principal Investigator Co-investigators: Abul Kashem MD PhD Patricia McDOnnell, RN
Conclusions• Fewer complications in selective PCI patients• Angina persisted in <8% of the PCI patient population• Mortality was low – Overall cardiac mortality ≤1% – Total non-cardiac mortality for 1-year 3.1%• Hospitalizations were related to persistent angina• Event-free survival suggests PCI can be performed safely in selective non-SOS hospitals Alfred A. Bove, 2 hospitals PCI w/o SOS PA demonstration project
Rescue PCI• Definition: PCI for failure of fibrinolytics – Clinical failure assessed at 60-90 minutes after fibrinolytics • Persistent chest pain or other active ischemic symptoms • Development of complications (e.g. heart failure, shock) • EKG with < 50% ST resolution in lead with previous maximal elevations suggests absence of reperfusion • Other clues: – No “reperfusion arrhythmias” – AIVR – No rapid release of biomarkers
Longer-Term Follow-Up of Patients inREACT (Rescue Angioplasty Versus Conservative Treatment or Repeat Thrombolysis) Trial
Long term MortalityAdjusted Hazard ratio for Longer Term Mortality
2011 ACC/AHA PCI Guidelines Rescue PCII IIa IIb III A strategy of immediate coronary angiography (or transfer for immediate coronary angiography) with intent to perform PCI is reasonable in patients with coronary angiography with STEMI, a moderate to large area of myocardium at risk, and evidence of failed fibrinolysis Levine, Circulation 2011
2007 STEMI Update Rescue PCI A strategy of coronary angiography with intent to perform PCI (or emergency CABG) is recommended in patients who have received fibrinolytic therapy and haveI IIa IIb III a. Cardiogenic shock in patients <75 years who are suitable candidates for revascularizationI IIa IIb III b. Severe congestive heart failure and/or pulmonary edema (Killip class III)I IIa IIb III c. Hemodynamically compromising ventricular arrhythmias
Routine PCI After Fibrinolysis In patients whose anatomy is suitable, PCI should be performed for the followingI IIa IIb III Objective evidence of recurrent MII IIa IIb III Moderate or severe spontaneous/ provocable myocardial ischemia during recovery from STEMII IIa IIb III Cardiogenic shock or hemodynamic instability
Pharmacoinvasive management• A strategy for patients who cannot be offered immediate primary PCI – E.g. non PCI centers where transfer for primary PCI cannot be achieved in recommended times• Fibrinolytics administered per current guidelines followed by transfer to PCI centers• PCI of the infarct related artery is subsequently performed• Strategy previously associated with bleeding complications and no clinical benefit – TIMI II trial
Early Invasive versus Standard Care after thrombolytics TRANSFER-AMI InvestigatorsPrimary composite of death, reinfarction, heart failure & shock at 30 days Cantor WJ. American College of Cardiology 2008 Scientific Sessions. March 30, 2008; Chicago, IL.
Early Invasive versus Standard Care after thrombolytics TRANSFER-AMI Investigators P=0.0013 1059 pts Time to PCI 192 minCantor WJ. American College of Cardiology 2008 Scientific Sessions. March 30, 2008;Chicago, IL.
Ischemic Events at Follow-up in Pharmaco-invasive TrialsVerheugt, NEJM 2009; 360, 26: 2779-2781
2011 ACC/AHA PCI Guidelines Pharmaco-invasive strategyI IIa IIb III A strategy of coronary angiography (or A transfer for coronary angiography) 3 to 24 hours after initiating fibrinolytic therapy with intent to perform PCI is reasonable for hemodynamically stable patients with STEMI and evidence for successful fibrinolysis when angiography and revascularization can be performed as soon as logistically feasible in this time frame. Levine, Circulation 2011
Conclusions• PCI w/o CABG back-up onsite can be performed• A set of related guidelines indicates the types of clinical protocols (critical pathways) and transferring affiliation agreements that ought to be in place – Longitudinal database participation – Peer review• Development of a well-functioning network is key• The 2012 questions are – Is it always appropriate? – Is if financially viable and under what criteria?