Primary Percutaneous Coronary Intervention

Optimizing Access to Primary PCI for ST Elevation Myocardial Infarction

FINAL REPORT

September 2010

table of contents

3

4 4 6

Foreword

Introduction Background

The Primary Percutaneous Coronary Intervention Subcommittee



7

Methods



7

Primary Percutaneous Coronary Intervention Literature Review



7

10

Findings

Primary Percutaneous Coronary Intervention Service in Ontario

10

Primary Percutaneous Coronary Intervention Program Development

10

Current Primary Percutaneous Coronary Intervention Services

12

Primary Percutaneous Coronary Intervention Data Collection

12 16

in Ontario: Guiding Principles

Available in Ontario

Staging of Primary Percutaneous Coronary Intervention Services

The Challenge: Overcoming Barriers to Access

29

Future Direction

34

Bibliography

30 37

40

55 56

References

Appendix 1: Glossary of Terms

Appendix 2: CCN Member Hospitals

Appendix 3: Ontario Cardiac Centres Primary Percutaneous Coronary Intervention Physician Leads

Appendix 4: Access to Urgent Percutaneous Coronary Intervention for Stemi: 16 Recommendations

59

Appendix 5: Canadian Cardiovascular Society Code Stemi Algorithm

61

Appendix 7: PPCI/STEMI Case Report Form/Data Dictionary

60

67

69

69

Appendix 6: CCN PCI/Stemi Case Report Form (Draft) Appendix 8: Nejm: A Citywide Stemi Protocol

Appendix 9: CCN Cath/PCI Working Group Appendix 10: Acknowledgements

primary percutaneous coronary intervention 1

Kori Kingsbury

The Cardiac Care Network of Ontario (CCN) serves an advisory role on adult cardiovascular care working closely with key stakeholders, including the Ministry of Health and LongTerm Care, Local Health Integration Networks, hospitals, health care providers, planners and researchers. Our focus and priority is quality of care, supporting leading practices and system-wide improvements to achieve excellence in patient care and clinical outcomes. In addition to monitoring and reporting on wait times and access to advanced cardiac services, CCN monitors and reports on other key performance metrics to ensure quality and efficiency within the system of adult cardiovascular services in Ontario. CCN is committed to sharing knowledge and information that fosters leading practices and helps to establish benchmarks and standards for optimal care. We are pleased to provide you with information relevant to programs providing regionalized care for acute myocardial infarctions, including primary percutaneous coronary intervention for ST elevation myocardial infarctions. We hope you find this document informative, and a resource to support your cardiac program. Yours truly, Kori Kingsbury Chief Executive Officer Cardiac Care Network of Ontario

2 primary percutaneous coronary intervention

Foreword As Chairs of the Primary Percutaneous Coronary Intervention Subcommittee (pPCI-SC) of the Cardiac Care Network, we are pleased to present this coaching document, Primary Percutaneous Coronary Intervention: Optimizing Access to Primary PCI for ST Elevation Myocardial Infarction. The purpose of this document is to provide a vehicle for knowledge transfer that will assist health care providers and planners in the adoption of leading practices in the provision of ST segment elevation myocardial infarction (STEMI) care. As part of the CCN’s coaching series to support leading practices, quality and performance improvement, this document outlines strategies that are proven to work, identifies the significant lessons learned and the critical steps in implementing a successful primary PCI (pPCI) program. We believe that success can be more broadly achieved by leveraging the experience and sharing the lessons learned of hospital programs and health care professionals in Ontario that have achieved the requisite level of services and demonstrated their ability to deliver integrated, regionally supported, 24 hour, 7 days a week (24/7) pPCI services. Within Ontario, The University of Ottawa Heart Institute, Kingston General Hospital, Hamilton Health Sciences Centre and Southlake Regional Health Centre were the early adopters of regional integrated pPCI STEMI programs to meet the needs of their communities. Experts from these hospitals were brought together by the pPCI-SC, in order to share their experiences and observations in establishing a 24/7 regional pPCI program with EMS field support. Currently there are 14 hospitals in Ontario providing some level of pPCI services for STEMI patients. Some centres are further along in the establishment of their comprehensive regional pPCI programs, while others are in the earlier stages of development.

Dr. James Velianou

Dr. Jean Francois Marquis

Primary angioplasty has been shown to be superior to fibrinolysis when delivered in a timely manner by experienced operators and teams. Leading practices for pPCI STEMI care are based on the ACC/AHA guidelines1 that recommend the interval between arrival at the hospital and intracoronary balloon inflation (“door-to-balloon” time) to be 90 minutes or less. A review of pPCI door-to-balloon (D2B) times at Ontario’s PCI centres demonstrated variable median D2B times with room for improvement across all centres to better align with the ACC/AHA recommendation. With CCN’s focus on equity, access, and quality of care, this served as a call to action to assess the alignment of practice with an accepted standard of care and accountability in delivering quality pPCI services. Building upon the principle, “the system helping the system,” it is hoped that this document will be a resource for other PCI centres and regions considering the implementation of a comprehensive, coordinated pPCI program based on leading practices. We wish to thank all committee members and CCN staff who assisted in the development of this document to promote equitable access to quality pPCI care for STEMI patients in Ontario. Sincerely, Dr. James Velianou, Hamilton Health Sciences Centre

Dr. Jean Francois Marquis, University of Ottawa Heart Institute

primary percutaneous coronary intervention 3

Introduction A significant proportion of patients in Canada are treated with pPCI for STEMI, however many others continue to be treated with fibrinolysis. Fibrinolysis is demonstrated to improve survival in a number of large randomized controlled trials when compared to medical therapy alone, however, pPCI has been shown to be superior to fibrinolysis when delivered in a timely manner by specially trained cardiologists and catheterization laboratory (cath lab) teams.2 This superiority is based on the reduction of morbidity (stroke and re-infarction) and mortality in patients presenting to or transferred to a pPCI capable centre. Patients not treated with any reperfusion therapy have significantly higher mortality in the range of 15–25%. Primary PCI (when it can be performed rapidly), as the preferred first treatment for STEMI, requires services to be delivered by personnel with an appropriate level of experience and training, in a setting with advanced cardiac diagnostic monitoring available 24/7, with the availability of immediate access. By leveraging the expertise and lessons learned of those PCI programs that have achieved this requisite level of service, the CATH/PCI Working Group of the Cardiac Care Network of Ontario (CCN) endorsed the development of a pPCI coaching document that could serve as a resource for other PCI centres and regions considering the provision of pPCI services. This document is to facilitate knowledge transfer by outlining strategies that have been demonstrated to work, significant lessons learned and the critical steps in implementing a successful pPCI program.

Background In 2004, CCN released its report, Access to Urgent PCI for ST Segment Elevation Myocardial Infarction. The report identified 16 recommendations (See Appendix 4) on how pPCI could be implemented in Ontario along with the following summary recommendation: “[where appropriate] pPCI should become the dominant strategy for the reperfusion of ST Segment Elevation Myocardial Infarction (STEMI) in Ontario.” The report outlined several key challenges to moving forward with this recommendation, including: 

Lack of an explicit provincial commitment to the systemic delivery of pPCI;



Need for a coordinated approach to advanced cardiac services delivery within a region;



Complexity in the deployment of emergency medical services (EMS) operations at the municipal level;



Availability of ambulance services and trained paramedics throughout the province; and

 C ardiac

cath lab resources (particularly human resources) that are necessary to expand capacity and ensure service availability 24/7;

4 primary percutaneous coronary intervention

 P hysical

resources, such as high acuity beds, to accommodate additional case load at PCI centres as well as at the referring hospitals;



Geographic limitations that result in transport delays to the nearest PCI centre; and



Repatriation of patients back to their referring centre or community hospital.

In spite of these challenges, four “early adopter” PCI centres in Ontario independently decided to work with their relevant stakeholders to develop and implement regional and integrated pPCI STEMI programs to meet the needs of their communities. These centres (in order of first to most recently implemented) include The University of Ottawa Heart Institute, Kingston General Hospital, Hamilton Health Sciences Centre, and Southlake Regional Health Centre. Success is not only defined in relation to direct benefits, such as improved patient outcomes, but also in terms of ongoing program evaluation, process improvement, and developing collaborative relationships. This not only contributes to leading practices with regard to the recommended ACC/AHA guideline of a 90-minute interval between first medical contact and intracoronary balloon inflation (D2B), but also provides a template for system-orientated care. In addition, from a regional perspective, pPCI STEMI care also establishes the key infrastructure that is needed to address other cardiovascular care issues, such as early stroke intervention. Irrespective of the documented benefits, access is a major limitation to a pPCI strategy for STEMI. With the extensive geography of the province, access to PCI is not available in every region of the province. In addition, up until recently, some of the PCI programs in Ontario did not provide 24/7 pPCI or only provided access to pPCI on a limited basis. Since April 2006, CCN has collected pPCI data to evaluate D2B times for the hospitals in Ontario providing pPCI. Preliminary analysis of these data suggests there is considerable practice variation and access to pPCI within the accepted timeframe of 90 minutes or less. “Time is myocardium” is perhaps one of the most explicit metaphors in cardiac care describing the imperative for urgency associated with access to the right care at the right time by the right people. As the pPCI service delivery unfolded across Ontario, there were no commonly agreed upon standards of practice for the organization of pPCI service delivery given the regional complexities and unique differences in geography and the Local Health Integration Networks (LHINs) across Ontario. While PCI providers saw this level of care as a priority for their centres, they were challenged to provide this level of service and were often limited by a lack of resources, support and/or infrastructure. With determination, perseverance and creativity, the majority of the PCI centres in Ontario were able to overcome these challenges and now provide pPCI with regional models of care. Subsequent to the work of this subcommittee, several other initiatives have been launched, and the majority of PCI centres in Ontario now offer pPCI for STEMI.

primary percutaneous coronary intervention 5

Access to, and delivery of, pPCI services to improve patient outcomes demands change in the organization and deployment of PCI services. There is a shared accountability between PCI centres, EMS services and referring hospitals. While process improvements can assist PCI centres to achieve the recommended guidelines for D2B time, leading practices involve extensive interdisciplinary collaboration and require explicit strategies for overcoming barriers to implementing organizational change. Organizations that have adopted and learned from these practices play a key leadership role in assisting other centres to improve patient access to pPCI services where appropriate. Since the 2004 publication of the CCN Access to Urgent PCI for ST Segment Elevation Myocardial Infarction report, several Ontario hospitals embarked on developing and successfully implementing pPCI programs. The collaboration between partner hospitals in the LHINs, engagement of key stakeholders in the planning and implementation of the programs has contributed greatly to the success of the programs. Successful education of EMS personnel that included ECG interpretation has been one of the main key success factors in transporting the patient from the field to the cath lab at the pPCI hospitals in a timely fashion. Today, Ontario has 14 hospitals providing PCI services, 11 full-service cardiac hospitals with on-site cardiac surgery and three stand-alone centres without cardiac surgery back-up. THE PRIMARY PERCUTANEOUS CORONARY INTERVENTION SUBCOMMITTEE

In recognition of what is required to support the successful implementation of integrated regional pPCI services in Ontario, the CCN CATH/PCI Working Group established the primary PCI Subcommittee (pPCI-SC) to provide guidance to the broader acute care cardiac community with regards to service organization and stakeholder collaboration at the system, organizational and local level. Membership on the pPCI-SC included a multidisciplinary group experienced with establishing pPCI and representing the 24/7 regional integrated EMS pPCI programs in Ontario. The scope of the pPCI-SC was to review the four fully operational, integrated regional pPCI programs in Ontario and identify key success factors and significant lessons learned, as well as the critical steps required for implementation. The specific deliverables included:  T he

creation of a coaching document to assist hospitals, LHINs, and policy makers in the planning and implementation of an integrated pPCI program; and document that would be based on the recommendations from the Report on Access to Urgent PCI, as well as expert opinion relevant to the lessons learned from programs that had successfully implemented a fully operational, integrated regional model for 24/7 pPCI.

 A 

The work of this subcommittee was accountable to the CCN Board of Directors through the Clinical Services Committee (CSC). The final report and recommendations were presented to the CSC and the CCN Board of Directors for final review and endorsement prior to distribution to other cardiac centres and relevant stakeholders, such as the LHINs and the MOHLTC.

6 primary percutaneous coronary intervention

Methods The development of this coaching document by the pPCI-SC has been informed through four specific processes that included: 1. A review of the current literature on the evidence supporting pPCI as a preferred treatment for STEMI; 2. A review of the CCN data on D2B times in Ontario; 3. A survey of a broad range of cardiac care stakeholders at all cardiac hospitals in the province to assess the priority associated with pPCI services at their centre and identify any challenges and potential barriers; and 4. An in-depth presentation from each committee member identifying the challenges and lessons learned in implementing a fully integrated 24/7 regional pPCI service. Members were asked to prepare a focused and comprehensive summary of their role in implementation. These were collated into a single document and reviewed by the entire committee for content and completeness. From the above activities, common themes, challenges, strategies and lessons learned emerged to aid in the development of a coaching framework to support the implementation of pPCI programs.

Findings PRIMARY PERCUTANEOUS CORONARY INTERVENTION LITERATURE REVIEW

The superiority of pPCI as an intervention for STEMI is based on the reduction of mortality (7% vs. 9%, p=0.0002), stroke (1% vs. 2%, p=0.0004), non-fatal re-infarction (3% vs. 7%, p
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