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 CenterNew York, NY

James B McClurken, MD, FACC, FCCP, FACS, FESCDirector of Thoracic Surgery

The Heart Institute, Doylestown Hospital, PAProfessor of Cardiothoracic Surgery

Temple University Hospital

Disclosures - McClurken

I 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 2012

CLASS IIa (Level of Evidence: B)1.Primary PCI is reasonable in hospitals without on-site cardiac surgery, provided that appropriate 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 accomplished and 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 cardiac surgery capabilities without a proven plan for rapid transport to a cardiac surgery operating room in a nearby hospital or without appropriate hemodynamic support capability 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 HospitalsPCI in non SOS Hospitals1 year follow-up 1 year follow-up

[2 hospitals [2 hospitals inin demonstration project in PAdemonstration project in PA]]

Co-investigators: Abul Kashem MD PhDPatricia McDOnnell, RN

Alfred A. Bove, MD PhD Alfred A. Bove, MD PhD Principal InvestigatorPrincipal Investigator

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 hospitalsAlfred A. Bove, 2 hospitals PCI w/o SOS PA demonstration projectAlfred 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 Mortality

Adjusted Hazard ratio for Longer Term Mortality

Rescue PCI

A strategy of immediate coronary A strategy of immediate coronary angiography (or transfer for immediate angiography (or transfer for immediate coronary angiography) with intent to coronary angiography) with intent to perform PCI is reasonable in patients perform PCI is reasonable in patients with coronary angiography with STEMI, with coronary angiography with STEMI, a moderate to large area of myocardium a moderate to large area of myocardium at risk, and evidence of failed fibrinolysisat risk, and evidence of failed fibrinolysis

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

2011 ACC/AHA PCI Guidelines

Levine, Circulation 2011

2007 STEMI UpdateRescue PCI

A strategy of coronary angiography withA strategy of coronary angiography withintent to perform PCI (or emergency CABG) isintent to perform PCI (or emergency CABG) isrecommended in patients who have receivedrecommended in patients who have receivedfibrinolytic therapy and havefibrinolytic therapy and have

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

a.a. Cardiogenic shock in patients <75 years who are Cardiogenic shock in patients <75 years who are suitable candidates for revascularizationsuitable candidates for revascularization

b. Severe congestive heart failure and/or pulmonary b. Severe congestive heart failure and/or pulmonary edema (Killip class III)edema (Killip class III)

c. Hemodynamically compromising ventricular c. Hemodynamically compromising ventricular arrhythmiasarrhythmias

Routine PCI After Fibrinolysis

Moderate or severe spontaneous/Moderate or severe spontaneous/provocable myocardial ischemia during provocable myocardial ischemia during recovery from STEMIrecovery from STEMI

In patients whose anatomy is suitable, PCIIn patients whose anatomy is suitable, PCIshould be performed for the following should be performed for the following

Objective evidence of recurrent MIObjective evidence of recurrent MI

Cardiogenic shock or hemodynamic instabilityCardiogenic shock or hemodynamic instability

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

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 Investigators

Early Invasive versus Standard Care after thrombolytics TRANSFER-AMI Investigators

Cantor WJ. American College of Cardiology 2008 Scientific Sessions. March 30, 2008; Chicago, IL.

Primary composite of death, reinfarction, heart failure & shock at 30 days

Early Invasive versus Standard Care after Early Invasive versus Standard Care after thrombolyticsthrombolytics

TRANSFER-AMI Investigators

Early Invasive versus Standard Care after Early Invasive versus Standard Care after thrombolyticsthrombolytics

TRANSFER-AMI Investigators

Cantor WJ. American College of Cardiology 2008 Scientific Sessions. March 30, 2008; Chicago, IL.

P=0.00131059 pts

Time to PCI 192 min

Ischemic Events at Follow-up in Pharmaco-invasive Trials

Verheugt, NEJM 2009; 360, 26: 2779-2781

Pharmaco-invasive strategy

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIII

AAIIaIIaIIa IIbIIbIIb IIIIIIIII

2011 ACC/AHA PCI Guidelines

Levine, Circulation 2011

A strategy of coronary angiography (or 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.

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?

Planning & execution to minimize risks

Originally a PA PCI w/o SOS demonstration hosp.; SOS since 2000

Final thoughts ….

Make sure the transfer team is on the same care pathway page & ready