STEMI - inesss

Standards regarding reperfusion treatments for ST-segment elevation acute myocardial infarction (STEMI) in Québec. November 2016. Institut national d'...

2 downloads 725 Views 300KB Size
Standards regarding reperfusion treatments for ST-segment elevation acute myocardial infarction (STEMI) in Québec November 2016 Institut national d’excellence en santé et en services sociaux (INESSS)

Cardiovascular Evaluation Unit (l’Unité d’évaluation cardiovasculaire, UECV) Under the direction of Michèle de Guise

Project Team Leila Azzi, M. Sc., biostatistician Chistiane Beauchamp, B. Sc., medical archivist consultant Peter Bogaty, M. D., medical and scientific advisor Lucy Boothroyd, Ph. D., professional scientist Céline Carroll, B. Sc., medical archivist consultant François Désy, Ph. D., professional scientist Huguette Dussault, secretary Laurie Lambert, Ph. D., unit coordinator Carole Sanscartier, A.M.A., medical archivist consultant

Production Coordinator Renée Latulippe Technical Support Hélène St-Hilaire

Senior Scientist Alicia Framarin, M. Sc. Scientific Director Michèle de Guise, M. D. Information Science Research Mathieu Plamondon, M.S.I. Documentary Support Flavie Jouandon

This work has been translated from the original French document entitled Normes relatives aux traitements de reperfusion de l’infarctus aigu du myocarde avec élévation du segment ST (IAMEST) au Québec, published by INESSS on September 6, 2016 and available on the INESSS website at: http://www.inesss.qc.ca/fileadmin/doc/INESSS/Rapports/Cardio/INESSS_Normes_IAMEST_VF.pdf

Expert committee (in alphabetical order) Dr. Jean-Pierre Déry, interventional cardiologist, Institut universitaire de cardiologie et de pneumologie de Québec (new member as of 2016) Dr. Richard Harvey, interventional cardiologist, Centre hospitalier universitaire de Sherbrooke Dr. Simon Kouz, cardiologist, Centre hospitalier régional de Lanaudière Dr. Philippe L’Allier, interventional cardiologist, Institut de cardiologie de Montréal Dr. Sébastien Maire, emergency physician, Centre hospitalier affilié universitaire Hôtel-Dieu de Lévis Dr. Maryse Mercier, internist, Hôtel-Dieu D’Arthabaska (new member as of 2016) Dr. Normand Racine, cardiologist, Réseau québecois de cardiologie tertiaire (RQCT) Dr. Stéphane Rinfret, interventional cardiologist, McGill University Health Centre Dr. Dave Ross, emergency physician, Services préhospitaliers d’urgence en Montérégie, Corporation d’Urgences-santé and Hôpital Sacre-Cœur de Montréal Dr. Eli Segal, emergency physician, Hôpital général juif de Montréal and Corporation d’Urgencessanté Advisory committee (Comité directeur of the RQCT) Dr. Normand Racine, Institut de cardiologie de Montréal, president Dr. François Philippon, Institut universitaire de cardiologie et de pneumologie de Québec – Hôpital Laval, outgoing president Dr. Martin Bernier, McGill University Health Centre – Montreal General Hospital Joël Brodeur, Direction du développement et du soutien professionnel, Ordre des infirmières et infirmiers du Québec Dr. Paul Farand, Centre intégré universitaire de santé et de services sociaux (CIUSSS) de l’Estrie, Centre hospitalier universitaire de Sherbrooke – Hôpital Fleurimont Dr. Onil Gleeton, Institut universitaire de cardiologie et de pneumologie de Québec – Hôpital Laval Dr. Peter Guerra, Institut de cardiologie de Montréal Dr. Georges Honos, Centre hospitalier de l’Université de Montréal – Hôpital Notre-Dame Nathalie Labrecque, Direction générale des services de santé et médecine universitaire, Ministère de la Santé et des Services sociaux, coordinatrice Dr. Michel Pellerin, Association des chirurgiens cardiaques et thoraciques du Québec Dr. Jean-Philippe Pelletier, Association des cardiologues du Québec Dr. Laurence Rudski, Hôpital général juif de Montréal Dr. Erick Schampaert, Centre intégré universitaire de santé et de services sociaux (CIUSSS) du Nord de l’île de Montréal, Hôpital du Sacré-Cœur de Montréal

External review Dr. Nicolas Danchin, cardiologist, Hôpital Européen Georges-Pompidou, Assistance publique Hôpitaux de Paris, Paris, France Declaration of interests Dr. Nicolas Danchin has received financial compensation or research support from Amgen, AstraZeneca, Daiichi Sankyo, Eli-Lilly, GSK, MSD, Novartis, Pfizer and Sanofi. He has received financing or travel expenses from Amgen, AstraZeneca, Bayer, Eli-Lilly and MSD. He has received financial compensation for written or verbal communication from Amgen, AstraZeneca, Bayer, BMS, Boehringer-ingelheim, Daiichi Sankyo, Eli-Lilly, GSK, MSD, Novartis, Novo Nordisk, Pfizer, Sanofi, Servier and The Medco. He is a consultant or expert for AstraZeneca, Amgen, Bayer, GSK, MSD, Novo Nordisk, Sanofi and Servier. Responsibility The Institut assumes entire responsibility for the final form and content of the present document.

TABLE OF CONTENTS ACRONYMS AND ABBREVIATIONS ................................................................................................................ ii INTRODUCT ION ........................................................................................................................................ 1 METHODS ................................................................................................................................................... 3 STANDARDS ............................................................................................................................................... 4 APPENDIX ................................................................................................................................................... 9 REFERENCES ................................................................................................................................................ 10

ACRONYMS AND ABBREVIATIONS ACTION-GWTG

Acute Coronary Treatment and Intervention Outcomes Network Registry – Get With the Guidelines (United States)

AETMIS

Agence d’évaluation des technologies et modes d’intervention en santé (Québec)

AHA

American Heart Association

CCN

Cardiac Care Network (Ontario)

CCS

Canadian Cardiovascular Society

ECG

Electrocardiogram

ESC

European Society of Cardiology

ETIAMEST

Évaluation terrain sur la prise en charge de l’IAMEST (Québec)

INESSS

Institut national d’excellence en santé et en services sociaux (Québec)

MSSS

Ministère de la Santé et des Services sociaux (Québec)

NICE

National Institute for Health and Care Excellence (United Kingdom)

PCI

Percutaneous coronary intervention

PPCI

Primary percutaneous coronary intervention

RACE

Reperfusion of Acute Myocardial Infarction in Carolina Emergency Departments (United States)

RCT

Randomized controlled trial

RQCT

Réseau québécois de cardiologie tertiaire

STEMI

ST-segment elevation myocardial infarction

ii

INTRODUCTION Background Acute myocardial infarction with ST-segment elevation (STEMI) is a serious and frequent condition that must be treated with great urgency either by percutaneous coronary intervention (PCI) or by fibrinolysis. There is an international consensus, echoed by numerous clinical practice guidelines [NICE, 2013; O’Gara et al., 2013; Steg et al., 2012; Welsh et al., 2009; Antman et al., 2004], recommending that treatment of STEMI be initiated within narrow and well-defined time windows in order to reduce mortality and morbidity. Data from Québec have shown that reperfusion treatment delivered outside of the maximal recommended delay is associated with statistically significant increases in mortality at 30 days and in mortality and readmission for acute myocardial infarction or heart failure at 1 year [Lambert et al., 2010]. In response to a request by the Québec Ministry of Health and Social Services (MSSS), the Agence d’évaluation des technologies et modes d’intervention en santé (AETMIS, which became the Institut national d’excellence en santé et en services sociaux, INESSS, in 2011) published a health technology assessment in 2008 that examined the evidence and practice guidelines regarding the reduction of treatment delays at different time points in the clinical pathway for patients with STEMI [AETMIS, 2008]. A monograph comparing the effectiveness and safety of primary PCI 1 (PPCI) and fibrinolysis was also published. According to the recommendations in the 2008 report, fibrinolysis and PPCI should be recognized as complementary modes of intervention where the choice of treatment depends on a variety of clinical and practical considerations. Hospitals, in collaboration with emergency prehospital services, are responsible for developing strategies to optimize the clinical pathways in order to minimize delays to both treatments. AETMIS recommended that that recourse to PPCI not be the preferred option when the expected door-toballoon time exceeds the maximum delay recommended in clinical practice guidelines, and that the initial decision to proceed to fibrinolysis or PPCI (when such a choice is possible) be based on an evaluation of the individual patient’s risk profile and the anticipated delays to both treatments [AETMIS, 2008]. Two field evaluations on STEMI care in Québec (ETIAMEST phase I and II) carried out by AETMIS in 2006-2007 and in 2008-2009 showed that delays to STEMI treatment were in general too long and often exceeded the recommended maximums [Lambert et al., 2012; Lambert et al., 2010; AETMIS, 2008]. Results also showed large variation in treatment delays between regions and between facilities. The transfer of patients from one hospital to another in order to receive PPCI had significant impact on lengthening the delays to treatment [Lambert et al., 2014]. Studies carried out in other jurisdictions arrived at the same conclusions [Herrin et al., 2011; Liebetrau et al., 2011; Wang et al., 2011; Estévez-Loureiro et al., 2010]. Following the results of ETIAMEST I, the Ministry of Health and Social Services published a Plan d’action ministériel sur le continuum de soins pour la prise en charge des patients avec IAMEST in October 2008 that made access to reperfusion treatment a priority and requested all health care partners concerned to mobilize their efforts towards this goal. The Réseau québécois de cardiologie tertiaire (RQCT) subsequently issued recommendations and a clinical algorithm for the treatment of STEMI patients in October 2009 [RQCT, 2010].

1

PCI is called “primary” or PPCI when it is the initial reperfusion treatment, without prior fibrinolysis.

1

Notably, the RQCT recommended: – –



that the direct transport of STEMI patients to PCI hospitals be favoured according to preestablished corridors of service within an ambulance transport radius of 60 minutes or less; that patients who can receive PPCI within 120 minutes after arrival at a non-PCI hospital be transferred to a PCI hospital according to pre-established corridors of service and formal agreements. If not, that fibrinolysis be administered in the absence of contraindications or high bleeding risk; that patients who present at a non-PCI hospital within 2 hours of symptom onset and who cannot receive PPCI within 90 minutes receive fibrinolysis before transfer to a PCI hospital. Since the period of observation of ETIAMEST I (October 2006 to March 2007), several important changes in the management of STEMI in Québec have taken place. In particular, there have been structural changes: the closing of catheterization laboratories in some centres and either additional facilities or entirely new laboratories in other hospitals. There have also been modifications in health care processes, including changes to the priority of calls for interhospital transfer, mandatory coding of STEMI in medicoadministrative databases and pilot prehospital electrocardiogram (ECG) programs in several regions. Since ETIAMEST II (Octobre 2008 to March 2009), other changes have occurred, in particular the expansion of the use of prehospital ECGs throughout the province, as well as, in some regions, transmission of prehospital ECGs for interpretation before the patient’s arrival in an emergency department or prior to direct transport to a catheterization laboratory. Several regions have in addition created quality improvement committees and have developed regional plans for use of prehospital ECGs in order to reduce ischemic time, as recommended by practice guidelines [O’Gara et al, 2013].

Objectives The overall objective of the present document is the harmonization and optimization of structures and processes in order to facilitate high quality management of patients with ST-segment elevation myocardial infarction (STEMI) during the acute phase of care. This document presents quality standards recommended for Québec, based on a review of the scientific literature and consensus work with a committee of clinical experts. The present document is relevant for: • health care professionals in prehospital teams and emergency departments who receive STEMI patients (including emergency physicians, interventional and non-interventional cardiologists, internists and paramedics); • other stakeholders and responsible parties (managers, decision-makers) who are closely or more distantly involved in the management of STEMI patients during the acute phase of care. The present document is accompanied by a report on the state of knowledge [INESSS, 2016]. This companion report represents a focused update of the health technology assessment by AETMIS [AETMIS, 2008]. It presents the detailed information extracted from the literature that was used to formulate the standards. The companion report addresses 1) the elements to be considered for the choice of reperfusion treatments and 2) factors that facilitate reduced delays to treatment.

2

METHODS This document was developed in collaboration with a committee of experts in cardiology, internal medicine and emergency medicine, including the prehospital domain. The committee includes members that were previously involved in the development of the study protocol for INESSS’s field evaluations of STEMI care (ETIAMEST) to whom were added two new members in 2016, one nominated by the Association des cardiologues du Québec and the other from the Institut universitaire de cardiologie et de pneumologie. A systematic search of the scientific literature (January 2011 to March 2016) was carried out using bibliographic databases, key words and reference lists of retained documents (details are presented in an appendix of the companion report on the state of knowledge). The literature retained included North American clinical practice guidelines and recommendations, recent Canadian studies and material regarding the Mission: Lifeline and Reperfusion of Acute Myocardial Infarction in Carolina Emergency Departments (RACE) initiatives in the United States. The American Heart Association (AHA)’s Mission: Lifeline is a large nation-wide program for improvement of STEMI care and is associated with the Acute Coronary Treatment and Intervention Outcomes Network – Get With the Guidelines (ACTION-GWTG) registry. RACE is the largest regionalized STEMI program at the level of an entire state (North Carolina). In summary, the development of the standards using consensus methods with the clinical experts was supported by: • A systematic review of the most recent clinical practice guidelines and recommendations

from North America and Ontario, as well as the clinical algorithm developed by RQCT and adopted by MSSS and • from documents not included by the clinical practice guidelines, an extraction of information and a synthesis of: ‒ key structures and processes of the Mission: Lifeline and RACE programs, as well as relevant results from the ACTION-GWTG registry ‒ key randomized controlled trials concerning the choice of reperfusion treatment and key studies (meta-analyses, systematic reviews, peer-reviewed Canadian publications) on facilitating factors relevant to North American initiatives ‒ key publications based on data from INESSS’s field evaluation of STEMI care in Québec (ETIAMEST phase I and II) and the previous technology assessment by AETMIS [AETMIS, 2008]. The consensus work involved two cycles of feedback on a working document, by electronic mail (beginning in April 2016), and a final deliberative process in person or by teleconference (in May and June 2016). The expert committee was asked to approve or modify each standard. External scientific validation of the document was carried out by an advisory committee composed of members of the Comité directeur of RQCT and by an external review.

3

STANDARDS Each standard is conceived to be measurable and actionable. The sources that support the standard, in part or in whole, are indicated in Italics, as well as the class of recommendation and the level of evidence when specified by the AHA guidelines (see the explanations of these classes and levels in the Appendix). These standards have been developed according to the following guiding principles: ‒ to offer the best quality of care possible to STEMI patients ‒ to assure timely access to care across the population of Québec. Reperfusion treatment should be offered to all eligible STEMI patients who present within 12 hours of symptom onset [O’Connor et al., 2015 [AHA], Class I, level A; O’Gara et al., 2013 [AHA], Class I, level A]. This treatment can also be considered for patients presenting, more rarely, in the first 12 to 24 hours after symptom onset in the presence of persistent ischemia based on clinical status and electrocardiographic results [O’Connor et al., 2015 [AHA], Class IIb, level B ; O’Gara et al., 2013 [AHA], Class IIa, level B]. Coherent with Canadian practice guidelines [Welsh et al., 2009], “first medical contact” refers to arrival of the paramedic at the patient’s side or triage for patients self-transported to hospital. “Paramedic” refers to Québec’s techniciens ambulanciers paramédics. Emergency prehospital services Standards #1 to 4 concern patients who activate the prehospital system. 1. All paramedics deployed in an ambulance should have access to cardiac monitors capable of 12-lead ECG acquisition. Sources: O’Connor et al., 2015 (AHA) [Class I, level B]; O’Gara et al., 2013 (AHA) [Class I, level B]; CCN, 2013a (Ontario); expert opinion

2. All paramedics should be trained in 12-lead ECG acquisition, using standardized training curricula and regular continuing education that also highlight clinical evaluation of patients.

Sources: O’Connor et al., 2015 (AHA) [Class I, level B]; O’Gara et al., 2013 (AHA) [Class I, level B]; CCN, 2013a (Ontario); Mission: Lifeline, 2013; Rokos et al., 2013 (Mission: Lifeline); expert opinion

3. All paramedics should use written protocols that specify for which patients ECGs are to be performed, how to communicate results and the processes to be followed (that is, rapid prealert of the receiving hospital, the choice of destination) based on the ECG findings and clinical evaluation of the patient by the paramedic. Given the limitations of computerized interpretation, transmission of the ECG for interpretation by a physician should be favoured at the provincial level.

Sources: O’Connor et al., 2015 (AHA) [Class IIb, level C regarding the second sentence]; O’Gara et al., 2013 (AHA); CCN, 2013a (Ontario); Nam et al., 2014 (meta-analysis); de Champlain et al., 2014 (study by Urgences-santé); expert opinion

4. For confirmed or probable STEMI patients, protocols should favour and facilitate direct transport by ambulance from the field to a designated PCI hospital for patients who can realistically achieve a delay of ≤ 90 minutes between first medical contact (arrival of the paramedic at the patient’s side) and first device with a view to PPCI, both during and outside of 4

regular working hours.

Sources: O’Connor et al., 2015 (AHA); O’Gara et al., 2013 (AHA) [Class I, level B]

Primary PCI (PPCI) with direct admission Standards #5 to 7 concern the management of patients who arrive directly at a PCI hospital, by ambulance or self-transport, and not those patients transferred from a non-PCI hospital. The designated PCI centres who receive ambulance patients transported from the scene should satisfy these standards. NOTE: “First device” refers to the deployment of the first device with intent to perform mechanical reperfusion. 5. A. The delay between first medical contact and first device should be ≤ 90 minutes, both during and outside of regular working hours.

Sources: O’Connor et al., 2015 (AHA) [Class I, level A]; O’Gara et al., 2013 (AHA); Quraishi et al., 2016 (CCS); CCN, 2013a (Ontario)

B. A PCI hospital should have a target to treat at least 75% of patients within the maximum delay recommended by clinical practice guidelines of ≤ 90 minutes between first medical contact and first device, both during and outside of regular working hours. Sources: Quraishi et al., 2016 (CCS); Mission: Lifeline, 2014; expert opinion

6. For patients transported by ambulance directly from the scene to a PCI hospital with a diagnostic prehospital ECG, arrival in the catheterization laboratory (rather than the emergency department) should be favoured in cases where the laboratory and the PPCI clinical team are ready to receive the patient. Sources: O’Gara et al., 2013 (AHA); O’Connor et al., 2015 (AHA); Fosbol et al., 2013 (RACE); Bagai et al., 2013a, b (ACTION-GWTG & RACE); Anderson et al., 2015 (ACTION-GWTG); Hagiwara et al., 2014 (metaanalysis)

7. A. If an ECG has to be acquired at the PCI hospital (in the absence of a diagnostic prehospital ECG), it should be performed and the results interpreted by a physician ≤ 10 minutes following arrival of the patient, both during and outside of regular working hours.

Sources: CCN, 2013a (Ontario); Mission: Lifeline, 2013; ETMIS, 2008, citing the AHA guidelines of Antman et al., 2004 (Class I, level C)

B. A PCI hospital should have a target to acquire the first inhospital ECG for at least 75% of patients within the maximum delay recommended by clinical practice guidelines of ≤ 10 minutes between triage and ECG, both during and outside of regular working hours. Sources: Mission: Lifeline, 2014; expert opinion

Initial arrival at a non-PCI hospital Standards #8 to 13 concern the management of patients who arrive at a non-PCI hospital, by ambulance or self-transport. NOTE: “First device” refers to the deployment of the first device with intent to perform mechanical reperfusion. 8. A. If an ECG has to be acquired at the non-PCI hospital (in the absence of a diagnostic prehospital ECG), it should be performed and the results interpreted by a physician ≤ 10 minutes following arrival of the patient, both during and outside of regular working hours.

Sources: CCN, 2013a (Ontario); Mission: Lifeline, 2013; ETMIS, 2008, citing the AHA guidelines of Antman et al., 2004 (Class I, level C)

5

B. A non-PCI hospital should have a target to acquire the first inhospital ECG for at least 75% of patients within the maximum delay recommended by clinical practice guidelines of ≤ 10 minutes between triage and ECG, both during and outside of regular working hours. Sources: Mission: Lifeline, 2014; expert opinion

9. A. If a patient does not present contraindications to fibrinolysis and the delay between first medical contact and first device is anticipated to be > 120 minutes, the administration of fibrinolysis should be favoured, according to a written protocol.

Sources: O’Connor et al., 2015 (AHA); O’Gara et al, 2013 (AHA) [Class I, level B]; CCN, 2013a (Ontario)

B. The delay between triage and administration of fibrinolysis should be ≤ 30 minutes, both during and outside of regular working hours.

Sources: O’Connor et al., 2015 (AHA) [Class I, level A]; O’Gara et al., 2013 (AHA) [Class I, level B]; CCN, 2013a (Ontario)

C. A non-PCI hospital should have a target to treat at least 75% of these patients within the maximum delay recommended by clinical practice guidelines of ≤ 30 minutes between triage and administration of fibrinolysis, both during and outside of regular working hours. Sources: Mission: Lifeline, 2014; expert opinion

Following administration of fibrinolysis, the AHA practice guidelines recommend that an ECG be evaluated after about 60 minutes in order to consider whether to set an interhospital transfer in motion with view to a rescue PCI [Antman et al., 2004; O’Gara et al., 2013]. This option would be particularly worth considering if the initial ST-segment elevation persists (less than 50% resolution), suggesting failed reperfusion. The optimal strategy is less clear concerning recourse to PCI if the fibrinolytic treatment appears to have been successful and the patient remains clinically stable. One of two approaches can be considered: routine transfer, generally in the first 6 to 24 hours after initial treatment (a “pharmacoinvasive strategy”), or a more selective transfer (an “ischemia-guided strategy”) in the case of persistent or recurrent ischemia or other factors. 10. In the presence of cardiogenic shock or contraindications to fibrinolysis, the patient should be transported as rapidly as possible to a PCI hospital. Sources: O’Gara et al., 2013 (AHA) [Class I, level B]

11. In order to perform routine interhospital transfers with a view to PPCI, a non-PCI hospital should have a target to treat at least 75% of transferred patients within the maximal delay recommended by clinical practice guidelines of ≤ 120 minutes between first medical contact and first device, both during and outside of regular working hours. Sources: Quraishi et al., 2016 (CCS); Mission: Lifeline, 2014; expert opinion

12. A. When transferring for PPCI, the delay from triage to departure from the emergency department of a non-PCI hospital should be ≤ 30 minutes, both during and outside of regular working hours. Sources: O’Connor et al., 2015 (AHA); O’Gara et al., 2013 (AHA); CCN, 2013a (Ontario); Wilson et al., 2013 (RACE)

B. A non-PCI hospital should have a target to have at least 75% of patients being transferred leave the emergency department within the maximal delay recommended by clinical practice guidelines of ≤ 30 minutes between triage and departure, both during and outside of regular working hours. Sources: expert opinion

6

13. For patients transferred for PPCI or subsequent to fibrinolysis treatment, the PCI hospital should routinely provide information concerning PCI (time, type of stent) to the referring physician at the non-PCI hospital. Sources: CCN, 2013a (Ontario); Mission: Lifeline, 2013; Rokos et al., 2013 (Mission: Lifeline); expert opinion

No reperfusion treatment 14. When no reperfusion treatment is delivered, the reason(s) should be documented in the medical chart.

Sources: CCN, 2013a (Ontario); Lambert et al., 2016 (ETIAMEST I and II); Masoudi et al., 2008 (AHA)

Networks: structure, integration of services and communication 15. A PCI hospital should maintain a PCI volume of 400 and a PPCI volume of at least 50, per year. Individual interventional cardiologists at each PCI hospital should maintain a minimum volume of 100 PCI and at least 25 PPCI, per year. These volumes should be calculated from an average based on a 3-year period. Sources: Quraishi et al., 2016 (SCC); CCN, 2013a (Ontario); expert opinion

16. Single call activation of the catheterization laboratory should be operational at the PCI hospital. Sources: O’Gara et al., 2013 (AHA); Jollis et al., 2012a (RACE)

17. The PCI clinical team should be ready to receive the patient at the catheterization laboratory ≤ 30 minutes after the activation call, both during and outside of regular working hours. Sources: O’Gara et al., 2013 (AHA); CCN, 2013a (Ontario); Jollis et al., 2012b (RACE); expert opinion

18. Each non-PCI hospital should be in partnership with a specific PCI hospital (on a non-refusal basis). Prehospital (ambulance) services should be integrated in this corridor of service. A second, “back-up” PCI hospital should be designated for use in exceptional circumstances.

Sources: O’Gara et al., 2013 (AHA); CCN, 2013a (Ontario); CCN, 2013b (Ontario); Mission: Lifeline, 2013; Rokos et al., 2013 (Mission: Lifeline); Jollis et al., 2012a (RACE); expert opinion

19. Each facility should designate a person responsible for quality improvement who keeps regularly informed of the facility’s performance with respect to STEMI patients served in its region. Sources: Masoudi et al, 2008 (AHA); Jollis et al., 2012b (RACE); expert opinion

20. Each facility should have a formal and dedicated continuous quality improvement committee that meets regularly to discuss management of STEMI patients, with minutes of meetings. Sources: CCN, 2013a (Ontario); expert opinion

21. According to standardized quality indicators (notably those related to targets specified in this document), each facility should monitor performance with respect to STEMI patients along the entire continuum of care, through annual review of a reasonable sample of cases. Sources: CCN, 2013a (Ontario); expert opinion

22. At least once a year, multidisciplinary meetings that promote collaboration and quality improvement should occur, with action plans being developed if judged pertinent. Participants should include medical and administrative managers of each hospital in a given corridor of service as well as all hospital and prehospital teams involved. At a minimum, the proportions of patients treated within recommended delays among a reasonable sample of cases should be reviewed with respect to:

7

– Patient arrival at first hospital and first inhospital ECG (#7B, 8B in this document) – First medical contact and first device, for patients with direct admission to a PPCI centre (#5B) – First medical contact and administration of fibrinolysis (#9B) – First medical contact and first device, for patients transferred for PPCI (#11) – Patient arrival at first hospital and departure from emergency department, for patients transferred for PPCI (#12B)

Sources: O’Gara et al., 2013 (AHA); CCN, 2013a (Ontario); Mission: Lifeline, 2013; Rokos et al., 2013 (Mission: Lifeline); Jollis et al., 2012b (RACE); Masoudi et al., 2008 (AHA); expert opinion

8

APPENDIX

Grading of the evidence and classes of recommendation ORGANISM

LEVEL OF EVIDENCE

American Heart Association, 2013 (O’Gara et al.)

A

American Heart Association et International Liaison Committee on Resuscitation, 2015 (O’Connor et al.)

A

American Heart Association, 2013 (O’Gara et al.) American Heart Association et International Liaison Committee on Resuscitation, 2015 (O’Connor et al.)

B C

B

C

Classes of recommendation (those specified in the present document) I IIa I IIb

DESCRIPTION

Data arise from many randomized controlled trials (RCT) or meta-analyses. Data arise from one randomized controlled trial or non-randomized studies. Data arise from consensus expert opinion, case studies or practice standards. High quality evidence arising from more than one RCT, or meta-analyses of high quality RCTs or several RCTs supporting the results of high quality registry-based studies Moderate quality evidence arising from several RCTs (or meta-analyses of these RCTs), or from one or more registry-based studies, observational or non-randomised that were well-conceived and well-executed (or meta-analyses of these studies) Registry-based studies or observational randomized or non-randomized studies with limitations with respect to conception or execution, or meta-analyses of these studies or mechanistic or physiological studies in humans

Benefits >>> risks Procedure/treatment should be carried out/ administered/other Benefits >> risks It is reasonable to carry out/administer/other the procedure/treatment. Benefits >>> risks Procedure/treatment should be carried out/ administered/other Benefits ≥ risks Procedure/treatment might be justified/ envisioned.

9

REFERENCES Agence d’évaluation des technologies et des modes d’intervention en santé (AETMIS). Infarctus aigu du myocarde avec élévation du segment ST (IAMEST) : enjeux organisationnels et économiques de la prise en charge. Report prepared by Peter Bogaty, Lucy J. Boothroyd, Laurie Lambert, Jean-Marie R. Lance and Daniel Paquette. ETMIS 2008;4(2):1-114. Anderson LL, French WJ, Peng SA, Vora AN, Henry TD, Roe MT, Kontos MC, Granger CB, Bates ER, Hellkamp A, Wang TY. Direct transfer from the referring hospitals to the catheterization laboratory to minimize reperfusion delays for primary percutaneous coronary intervention: insights from the national cardiovascular data registry. Circ Cardiovasc Interv 2015; 8(9):e002477. Antman EM, Anbe DT, Armstrong PW, Bates ER, Green LA, Hand M, Hochman JS, Krumholz HM, Kushner FG, Lamas GA, Mullany CJ, Ornato JP, Pearle DL, Sloan MA, Smith SC Jr; American College of Cardiology; American Heart Association; Canadian Cardiovascular Society. ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction: Executive summary. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to revise the 1999 guidelines for the management of patients with acute myocardial infarction). J Am Coll Cardiol 2004; 44(3):671-719. Bagai A, Jollis JG, Dauerman HL, Peng SA, Rokos IC, Bates ER, French WJ, Granger CB, Roe MT. Emergency department bypass for ST-Segment-elevation myocardial infarction patients identified with a prehospital electrocardiogram: a report from the American Heart Association Mission: Lifeline program. Circulation 2013a; 128(4):352-9. Bagai A, Al-Khalidi HR, Muñoz D, Monk L, Roettig ML, Corbett CC, Garvey JL, Wilson BH, Granger CB, Jollis JG. Bypassing the emergency department and time to reperfusion in patients with prehospital ST-segment-elevation: findings from the reperfusion in acute myocardial infarction in Carolina Emergency Departments project. Circ Cardiovasc Interv 2013b;6(4):399-406. Brown KA, Lambert LJ, Brophy JM, Nasmith J, Rinfret S, Segal E, Kouz S, Ross D, Harvey R, Maire S, Boothroyd LJ, Bogaty P. Impact of ECG findings and process-of-care characteristics on the likelihood of not receiving reperfusion therapy in patients with ST-elevation myocardial infarction: results of a field evaluation. PLoS One 2014; 9(8):e104874. Cardiac Care Network (CCN). Recommendations for Best-Practice STEMI Management in Ontario. Toronto, ON: CCN; 2013a. Available: http://www.ccn.on.ca/ccn_public/uploadfiles/files/Recommendations_for_Best_Practice_S TEMI_Management_in_Ontario_%286%29.pdf. Cardiac Care Network (CCN). Development of a regional cardiac program: Core competencies and functions of a regional cardiac program. Toronto, ON: CCN; 2013b. Available: http://www.ccn.on.ca/ccn_public/uploadfiles/files/Regional%20Cardiac%20Program%20De velopment.pdf. Cardiac Care Network (CCN). Primary percutaneous coronary intervention. Optimizing access to primary PCI for ST elevation myocardial infarction. Toronto, ON: CCN; 2010. Available: http://www.ccn.on.ca/ccn_public/uploadfiles/files/CCN_10012_PPCI_Report_Update_Oct. pdf. 10

de Champlain F, Boothroyd LJ, Vadeboncoeur A, Huynh T, Nguyen V, Eisenberg MJ, Joseph L, Boivin JF, Segal E. Computerized interpretation of the prehospital electrocardiogram: predictive value for ST segment elevation myocardial infarction and impact on on-scene time. CJEM 2014;16(2):94-105. Estévez-Loureiro R, Calviño-Santos R, Vázquez-Rodríguez JM, Marzoa-Rivas R, Barge-Caballero E, Salgado-Fernández J, Aldama-López G, Barreiro-Díaz M, Varela-Portas J, Freire-Tellado M, Vázquez-González N, Castro-Beiras A. Direct transfer of ST-elevation myocardial infarction patients for primary percutaneous coronary intervention from short and long transfer distances decreases temporal delays and improves short-term prognosis: the PROGALIAM Registry. EuroIntervention 2010; 6(3):343-9. Fosbol EL, Granger CB, Jollis JG, Monk L, Lin L, Lytle BL, Xian Y, Garvey JL, Mears G, Corbett CC, Peterson ED, Glickman SW. The impact of a statewide pre-hospital STEMI strategy to bypass hospitals without percutaneous coronary intervention capability on treatment times. Circulation 2013;127(5):604-12. Hagiwara MA, Bremer A, Claesson A, Axelsson C, Norberg G, Herlitz J. The impact of direct admission to a catheterisation lab/CCU in patients with ST-elevation myocardial infarction on the delay to reperfusion and early risk of death: results of a systematic review including meta-analysis. Scand J Trauma Resusc Emerg Med 2014;22:67. Herrin J, Miller LE, Turkmani DF, Nsa W, Drye EE, Bernheim SM, Ling SM, Rapp MT, Han LF, Bratzler DW, Bradley EH, Nallamothu BK, Ting HH, Krumholz HM. National performance on door-in to door-out time among patients transferred for primary percutaneous coronary intervention. Arch Intern Med 2011; 171(21):1879-86. Institut national d’excellence en santé et en services sociaux (INESSS). Traitements de reperfusion de l’infarctus aigu du myocarde avec élévation du segment ST (IAMEST) et réduction des délais : mise à jour de la littérature. Document rédigé par l’Unité d’évaluation cardiovasculaire (UÉCV). Québec, Qc : INESSS; 2016. Jollis JG, Granger CB, Henry TD, Antman EM, Berger PB, Moyer PH, Pratt FD, Rokos IC, Acuña AR, Roettig ML, Jacobs AK. Systems of care for ST-segment-elevation myocardial infarction: a report From the American Heart Association’s Mission: Lifeline. Circ Cardiovasc Qual Outcomes 2012a; 5(4):423-8. Jollis JG, Al-Khalidi HR, Monk L, Roettig ML, Garvey JL, Aluko AO, Wilson BH, Applegate RJ, Mears G, Corbett CC, Granger CB; Regional Approach to Cardiovascular Emergencies (RACE) Investigators. Expansion of a regional ST-segment-elevation myocardial infarction system to an entire state. Circulation 2012b;126(2):189-95. Lambert LJ, Brophy JM, Racine N, Rinfret S, L’Allier PL, Brown KA, Boothroyd LJ, Ross D, Segal E, Kouz S, Maire S, Harvey R, Kezouh A, Nasmith J, Bogaty P. Outcomes of patients with STelevation myocardial infarction receiving and not receiving reperfusion therapy: the importance of examining all patients. Can J Cardiology 2016, 4 mars [Epub ahead of print]. Lambert LJ, Brown KA, Boothroyd LJ, Segal E, Maire S, Kouz S, Ross D, Harvey R, Rinfret S, Xiao Y, Nasmith J, Bogaty P. Transfer of patients with ST-elevation myocardial infarction for primary percutaneous coronary intervention: a province-wide evaluation of “door-in to door-out” delays at the first hospital. Circulation 2014; 129(25):2653-60.

11

Lambert LJ, Xiao Y, Kouz S, Rinfret S, Ross D, Segal E, L’Allier PL, Maire S, Vanasse A, Carroll C, Beauchamp C, Giguère M, Bogaty P. The importance of assessing inter-regional systems of healthcare in patients with ST-elevation myocardial infarction (STEMI): Examples from a systematic field evaluation. Circ Cardiovasc Qual Outcomes 2012;5(3 Suppl 1):abstract A195. Lambert LJ, Brown K, Segal E, Brophy J, Rodes-Cabau J, Bogaty P. Association between timeliness of reperfusion therapy and clinical outcomes in ST-elevation myocardial infarction. JAMA 2010; 303(21):2148-2155. Liebetrau C, Szardien S, Rixe J, Woelken M, Rolf A, Bauer T, Nef H, Möllmann H, Hamm C, Weber M. Direct admission versus transfer of AMI patients for primary PCI. Clin Res Cardiol 2011; 100(3):217-25. Masoudi FA, Bonow RO, Brindis RG, Cannon CP, Debuhr J, Fitzgerald S, Heidenreich PA, Ho KK, Krumholz HM, Leber C, Magid DJ, Nilasena DS, Rumsfeld JS, Smith SC Jr, Wharton TP Jr, DeLong E, Estes NA 3rd, Goff DC Jr, Grady K, Green LA, Loth AR, Peterson ED, Radford MJ, Rumsfeld JS, Shahian DM; ACC/AHA Task Force on Performance Measures. ACC/AHA 2008 statement on performance measurement and reperfusion therapy: a report of the ACC/AHA Task Force on Performance Measures (Work Group to address the challenges of performance measurement and reperfusion therapy). Circulation 2008;118(24):2649-61. Mission: Lifeline. Recommendations for criteria for STEMI systems of care. August, 2013. Available: http://www.heart.org/HEARTORG/HealthcareResearch/MissionLifelineHomePage/EMS/Rec ommendations-for-Criteria-for-STEMI-Systems-ofCare_UCM_312070_Article.jsp#.VwRjSfnhDIU. Mission: Lifeline. Hospital Recognition Program. June, 2014. Available: http://www.heart.org/idc/groups/heartpublic/@private/@wcm/@hcm/@ml/documents/downloadable/ucm_449164.pdf. Nam J, Caners K, Bowen JM, Welsford M, O’Reilly D. Systematic review and meta-analysis of the benefits of out-of-hospital 12-lead ECG and advance notification in ST-segment elevation myocardial infarction patients. Ann Emerg Med 2014;64(2):176-86, 186.e1-9. National Institute for Health and Care Excellence (NICE). Myocardial infarction with ST-segment elevation. The acute management of myocardial infarction with ST-segment elevation. NICE clinical guideline 167. NICE: Manchester, UK; 2013. Available: http://guidance.nice.org.uk/cg167. O’Connor RE, Al Ali AS, Brady WJ, Ghaemmaghami CA, Menon V, Welsford M, Shuster M. Part 9: Acute Coronary Syndromes: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation 2015;132(18 Suppl 2):S483-500. O’Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM,Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso JE, Tracy CM, Woo YJ, Zhao DX; CF/AHA Task Force. 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction: Executive Summary. A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation 2013; 127(4):529-555. 12

Quraishi AuR, Lambert LJ, Madan M, Gong Y, Forsey A, Galbraith D, et al. Quality of care for percutaneous coronary intervention: Development of Canadian Cardiovascular Society quality indicators. Can J Cardiol 2016 [Epub ahead of print]. Réseau québécois de cardiologie tertiaire (RQCT). Algorithme clinique : infarctus aigu du myocarde avec élévation du segment ST. Québec, QC: MSSS; 2010. Available: http://publications.msss.gouv.qc.ca/msss/fichiers/2010/10-906-02.pdf. Rokos IC, Henry TD, Weittenhiller B, Bjerke CM, Bates ER, French WJ. Mission: Lifeline STEMI networks geospatial information systems (GIS) maps. Crit Pathw Cardiol 2013;12(2):43-4. Steg PG, James SK, Atar D, Badano LP, Blomstrom-Lundqvist C, Borger MA, et al. ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J 2012;33(20):2569-619. Wang T, Nallamothu BK, Krumholz H, et al. Association of door-in to door-out time with reperfusion delays and outcomes among patients transferred for primary percutaneous coronary intervention. JAMA 2011; 305:2540-2547. Welsh RC, Travers A, Huynh T, Cantor WJ. Canadian Cardiovascular Society Working Group: Providing a perspective on the 2007 focused update of the American College of Cardiology and American Heart Association 2004 guidelines for the management of ST elevation myocardial infarction. Can J Cardiol 2009; 25(1):25-32. Wilson BH, Humphrey AD, Cedarholm JC, Downey WE, Haber RH, Kowalchuk GJ, et al. Achieving sustainable first door-to-balloon times of 90 minutes for regional transfer ST-segment elevation myocardial infarction. JACC Cardiovasc Interv 2013;6(10):1064-71.

13