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Endovascular therapy for acute ischemic stroke PDF

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Alberta STE Report pre Endovascular therapy for acute ischemic st roke August 2017 INSTITUTE OF HEALTH ECONOMICS The Institute of Health Economics (IHE) is an independent, not-for-profit organization that performs research in health economics and synthesizes evidence in health technology assessment to assist health policy making and best medical practices. IHE BOARD OF DIRECTORS Chair Dr. Lorne Tyrrell – Professor & Director, Li Ka Shing Institute of Virology, University of Alberta Government and Public Authorities Mr. Justin Riemer – Assistant Deputy Minister, Alberta Health Mr. Jason Krips – Deputy Minister, Economic Development and Trade Mr. Reg Joseph – VP Health, Alberta Innovates Dr. Kathryn Todd – VP Research, Innovation & Analytics, Alberta Health Services Academia Dr. Walter Dixon – Associate VP Research, University of Alberta Dr. Jon Meddings – Dean of Medicine, University of Calgary Dr. Richard Fedorak – Dean of Medicine & Dentistry, University of Alberta Dr. Ed McCauley – VP Research, University of Calgary Dr. Neal Davies – Dean of Pharmacy & Pharmaceutical Sciences, University of Alberta Dr. Braden Manns – Svare Chair in Health Economics and Professor, Departments of Medicine and Community Health Sciences, University of Calgary Dr. Constance Smith – Chair, Department of Economics, University of Alberta Industry Mr. Robert Godin –Director, Market Access Strategy & External Relations, AstraZeneca Ms. Jennifer Chan – VP, Policy & Communications, Merck Canada IHE Mr. Doug Gilpin – Chair, Audit & Finance Committee Dr. Christopher McCabe – Executive Director & CEO, Institute of Health Economics Ms. Allison Hagen – Director of Finance, Operations & Administration, Institute of Health Economics Alberta STE Report Endovascular therapy for acute ischemic stroke Alberta STE Report: Policy-driven Health Technology Assessment reports that include an analysis of the social and system demographics, technological effectiveness, and economic implications of a health technology. The reports are written under contract with the Alberta Health Technologies Decision Process and contextualized for use in Alberta. Acknowledgements The Institute of Health Economics is grateful to: • Expert Advisory Group • Health Evidence and Policy Unit, Alberta Health • Business Advisory Services at Alberta Health Services, Alberta Health Services • Cardiovascular Health & Stroke – Strategic Clinical Networks, Alberta Health Services • Clinical Analytics (DIMR) Unit, Alberta Health Services • Clinical Neurosciences Unit, Alberta Health Services • Community Accessible Rehabilitation (CAR) Program, Alberta Health Services • Customer Relationship Management (CRM) and Data Access Unit, Alberta Health • Department of Community Health Sciences, University of Calgary • Department of Health Technology Assessment, University of Calgary • Department of Surgery (Division of Neurosurgery), University of Saskatchewan • Diagnostic Imaging Unit (Senior Administration), Alberta Health Services • Dispatch Communications and Deployment Unit, Emergency Medical Services (EMS), Alberta Health Services • Emergency – Strategic Clinical Networks, Alberta Health Services • Emergency Health Services Unit, Alberta Health • Emergency Link Centre (ELC) and Operations, Shock Trauma Air Rescue Society (STARS) • Health Technology Assessment and Innovation Unit, Alberta Health Services • Information Management & Technology Services, EMS, Alberta Health Services • Intergovernmental Relations Branch, Alberta Health • Patient/Care Based Funding, Alberta Health Services • Poison and Drug Information Services (PADIS) & Referral, Access, Advice, Placement, Information and Destination (RAAPID) Unit(s), Alberta Health Services • Provincial Air Ambulance Operations & Inter-Facility Patient Transfer (IFT) Strategy Unit, EMS, Alberta Health Services • Quality Improvement & Clinical Research (QuICR), University of Calgary • Strategic Capital Planning, Capital Management, Alberta Health Services • Stroke Prevention Clinic, Calgary Stroke Program, Alberta Health Services • System Performance and Innovation (SPI) Unit, EMS, Alberta Health Services The views expressed in this report are of the Institute of Health Economics. Corresponding Author Please direct any inquiries about this report to Dr. Bing Guo, [email protected]. Endovascular therapy for acute ischemic stroke i Funding This report was supported by a financial contribution from Alberta Health (AH) through the Alberta Health Technologies Decision Process, the Alberta model for health technology assessment and policy analysis. The completed report was submitted to AH in May 2017. The views expressed herein do not necessarily represent the official policy of Alberta Health. Declared Competing Interest of Authors Competing interest is considered to be financial interest or non-financial interest, either direct or indirect, that would affect the research contained in this report or create a situation in which a person’s judgement could be unduly influenced by a secondary interest, such as personal advancement. The authors of this publication claim no competing interest. Suggested Citation (ICMJE or Vancouver Style) Institute of Health Economics. Endovascular therapy for acute ischemic stroke. Edmonton (AB): Institute of Health Economics; 2017. Web Address This publication is available for free download from the IHE website at http://www.ihe.ca. Reproduction, redistribution, or modification of the information for any purposes is prohibited without the express written permission of the Institute of Health Economics Institute of Health Economics, 2017 www.ihe.ca Endovascular therapy for acute ischemic stroke ii Executive Summary Background Stroke care in Alberta is evolving to incorporate advancements in technology such as endovascular therapy (EVT) into the current standard of care, which is typically a pharmaceutical intervention using tissue plasminogen activator (tPA; also called alteplase). However, there are concerns regarding the ability to provide EVT, given that the treatment can only be provided at two hospitals in Alberta (comprehensive stroke centres, in Edmonton and Calgary), and within a narrow window from time of stroke onset (that is, within 6 hours, the ultra-acute period of acute ischemic stroke). Therefore, several strategies need to be in place to make EVT available to all eligible patients, including those located in rural and other remote areas where there is no immediate access to EVT. Accordingly, there was a need to conduct an evidence assessment contextualized to the Alberta setting, particularly with regards to the impact of providing EVT to all eligible patients versus maintaining the status quo. Alberta STE Evidence Assessment This evidence assessment was conducted under the auspices of the Alberta Health Technology Decision Process. This process involves the use of appropriate evidence and information for decision-making regarding the public provision of health technologies and services. These assessments consider existing evidence and other information relevant to three areas: • social and system demographics (S section); • technology effects and effectiveness (T section); and • economic analysis (E section). Social and System Demographics The objective of the S section of this STE report is to provide information describing the burden of acute stroke, the current situation of stroke care in the province of Alberta, the current care pathways associated with the administration of both EVT and tPA, and the related health outcomes after EVT. Accessibility/acceptability, patient/public views, facilitators/barriers, social/ethical/legal considerations, and health system capacity in Alberta with regards to providing EVT will also be described. A brief description of policy and practice regarding EVT in other jurisdictions of Canada will be reported. Findings from the jurisdictional scan and resource requirements for province-wide implementation of EVT are briefly summarized in Tables ES.1 and ES.2 below. Endovascular therapy for acute ischemic stroke iii TABLE ES.1: Canadian jurisdictions providing EVT (as of 31 December 2016) Protocol for transporting patients Began providing EVT procedures Province/Territory who might benefit from EVT EVT per year British Columbia No January 2016a 210b Alberta Yesc 2010d 195e Saskatchewan Yes 2008 50 Manitoba No 2005 Not specifiedf Ontario Yesc February 2015g 351h Quebec Yes Summer 2015 180i Newfoundland and Labrador NR NR NR Nova Scotia Yesj,k 2012 18i Nol New Brunswick No 2006 30-50 Prince Edward Island NR NR NR Nunavut NR NR NR Yukon NR NR NR Northwest Territories NR NR NR Source: Provinces/territories were surveyed regarding their use of EVT and associated protocols, and seven provided answers (British Columbia, Alberta, Manitoba, Ontario, Quebec, Nova Scotia, and New Brunswick); additional information was obtained from a report on EVT performed by the HTA Unit at the University of Calgary a Some procedures performed earlier, in a non-programmatic way b Since January 2016 c Interim, final under development d The first use of a stent retriever was in 2010. However, EVT started earlier in the context of randomized controlled trials in the mid-2000s. After the ESCAPE trial in January 2015, EVT was done consistently e Approximately, 135 EVT procedures in Calgary and 60 in Edmonton are performed per year f Currently, Manitoba has no volume for this procedure. EVT is provided when resources are able to patients within the Winnipeg Regional Health Authority g Some centres in Ontario have been performing EVT since 2005 as participants in research trials. In February 2015, the Ontario Stroke Network established a provincial workgroup to develop an EVT implementation strategy h In 2015/16 i In 2015 j For areas surrounding the site where EVT is provided: Halifax/Dartmouth/West Hants/Eastern Shore k Patients with terminal cancer and living in nursing home with dementia are excluded from EVT l For areas outside of the central part of the province, there is a protocol drafted but is not in place yet; patients are currently transferred on a case-by-case basis from areas outside of the central part of the province NR: no response Endovascular therapy for acute ischemic stroke iv TABLE ES.2: Resources necessary for implementing EVT, by care pathway stage Additional resource Current resource needs Capacity issues Training issues needs EMS • Ground – paramedics (2 No capacity issues for EMS No training issues are No additional needs per team) ground, fixed-wing air foreseen; all required required • STARS – 2 pilots, 1 RN, ambulances, or STARS to protocols are being absorb the EVT demand developed and 1 paramedic piloted, and will be • Fixed-wing air implemented in the ambulance – 2 pilots, 2 near future without paramedics or 1 EMT, affecting the system and 1 paramedic • Dispatch and STARS Emergency Link Centre service (i.e., 4- way communication involves EMS practitioner, stroke neurologist, transport physician, RAAPID) • RAAPID for communications link Emergency department • Emergency physician • Emergency departments are • In Edmonton, pre- In Edmonton, a consult working at 150-180% of their hospital algorithms business plan is being • Emergency hospital visit capacity, regardless of the are being created to put forward to hire a (includes nursing, facility presenting conditions; capacity reduce the load at nurse (neurology/ICU issues need to be discussed the U of A Hospital; nurse) who will help to costs) from a system perspective in order to reduce the burden on • In Edmonton, there was implement this, emergency department previously inadequate nursing EMS personnel will nurses at the U of A support for EVT procedures at be trained for at Hospital the U of A Hospital, meaning a least 3 months (in- kind contribution nurse would be taken from the emergency department when from the EMS needed, potentially putting program) strain on the emergency • Education in rural department communities regarding protocols and how to use LAMS are needed to reduce door-to- needle times and reduce the burden of EVT cases for rural emergency departments Endovascular therapy for acute ischemic stroke v Additional resource Current resource needs Capacity issues Training issues needs Diagnostic imaging • CT AHS diagnostic imaging services • Professionals need • Increase funding for • CTA head scan have the capacity to respond to to be trained to staff training, staff the expected volume of EVT; satisfy demand costing, operational • Radiologist however, they need to expand in • Training takes costs, and • CT technologist some places where they do not approximately 6-8 interpretational costs have 24/7 availability of a weeks, and is done • Anticipate that neurologist/radiologist to interpret on-site with a minimum 30 the images hands-on approach technologists need to • Personnel need to be trained physically be at • Several costs need to either the U of A be taken into Hospital or Foothills consideration for on- Medical Centre for site training: travel at least 2 weeks to costs, be able to perform accommodation, AHS the procedures per diem, plus repeatedly replacement costs to pay personnel to cover the person in training Telehealth • Neurologist consult • No capacity issues are No training issues are Solution unknown (a • RAAPID for expected; however, there are foreseen combination of some issues with the current equipment, software, communications link technology and software, and troubleshooting • Telestroke capability which can limit the timely may be needed) • Central infrastructure access to EVT in some areas (e.g., Supernet) to allow (e.g., North Region) transfer of images • Neurologists paid by the fee- • Software at the for-service model have raised receiving end to see concerns about the increased and review images number of calls involved to determine eligibility for EVT tPA • 1 vial is 100mg, $2,700 No capacity issues are expected No training issues are No additional needs are • IV tubing, IV pump, etc. foreseen required • Neurologist consult to administer tPA EVT Angiography suite • It is anticipated that the No training issues are In Calgary, another including imaging number of angiography suites foreseen angiography suite with technology (biplane angio) in Edmonton will cover demand appropriate staffing is • Calgary has 3 suites that are required working at capacity; the equipment has not been renewed for at least 20 years Endovascular therapy for acute ischemic stroke vi Additional resource Current resource needs Capacity issues Training issues needs Angiography team: • There are sufficient No training issues are In Edmonton, there are • Neurointerventionalist neurointerventionalists to foreseen two options, either: (physician) – currently perform EVT procedures (9 in a) Increase of 4.2 FTE either a neurosurgeon Edmonton, 5 in Calgary) RNs to manage or neuroradiologist • There is a shortage of both critical care needs of • RN – angiography angiography nurses and EVT and other scrub nurse/DI technical nurses for the medical team in patients nurse who can manage the angiography suite OR the angiography suite • In Edmonton, with 2 nurses b) Increase of 2.1 FTE • RN/LPN – angiography and 2 technologists now on call RNs to manage rotating nurse for room after hours, no further issues critical care needs of and DI tech are anticipated for the EVT EVT patients, plus call management of the procedure itself; however, back there is still a shortage of care imaging modality In Calgary: nurses Medical team: • It would be ideal to • Calgary has only one on-call • Neurologist OR increase 2.8 FTE of team for both neurological and anaesthetist – to nurses to have full non-neurological interventions manage the patient coverage for the after hours neurology unit and • RN – to manage the • In Calgary, a nurse from the EVT patient neurology unit assists with • In addition, another • Device and materials patient care during an EVT nurse and tech on call procedure; this model has would be required functioned very well to keep the continuity of care of the patients. However, this nurse leaves the neurology unit in order to help with the EVT procedure, generating some strain in the unit Hospital admission • Hospital bed for stroke • In Edmonton, hospital In Edmonton, to In Edmonton, if the (includes nursing, etc.) admission services at the U of implement the pre- strategies for redirecting • Neurologist subsequent A Hospital is at 104% of its hospital algorithm patients to other visit (after consult for capacity, regardless of the strategy to redirect hospitals do not work, presenting conditions; capacity patients to other an increase in inpatient initial treatment) issues need to be discussed hospitals, EMS beds and personnel • Neurologist discharge from a system perspective personnel will be would be needed (not a visit • Strategies are being created so trained for at least 3 realistic possibility) months (in-kind that patients not requiring the contribution from the services of the U of A Hospital can be redirected/moved to EMS program) another hospital within 1-2 days • In Calgary, although all the beds in the neurology unit are occupied and they are at 100% or more of their capacity, they have protocols and processes in place to be able to absorb the demand of new EVT patients Endovascular therapy for acute ischemic stroke vii

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