Download CANADIAN ARRHYTHMIA NETWORK 2015 Operating Grant

CANADIAN ARRHYTHMIA NETWORK
2015 Operating Grant Competition
RMC Funding Recommendation
June 10, 2015
Reviewer
Score
88.4
Code
15-P01-001
Program Title
Assessment Of
Norepinephrine Transport
Inhibition To Prevent
Recurrent Vasovagal
Syncope (POST ATOM)
Validation and
Implementation of the
Canadian Syncope Risk
Scale for Risk-Stratification
of Syncope Patients in the
Emergency Department
Remote patient management
for Cardiac Implantable
Electronic Devices (RPMCIED)
Atrial Image-guided
Decision to Optimize
Treatment of Atrial
Fibrillation (AID-AF)
Early Invasive vs. Delayed
Intervention for Atrial
Fibrillation
Name
Dept
Instition
Disease CANet CIHR Relevance Relevance Relevance
Foci
Theme Pillar
to CIHR
to NSERC to SSHRC
CANet
Year1
CANet
Year2
CANet
Year3
Partner
Year1
Partner
Year2
Partner
Year3
Robert
Sheldon
Cardiac
Sciences
University
of Calgary
Syn
T2
P2, P3
70%
0%
30%
124,994
124,935
0
145,250
147,489
0
Venkatesh
Thirguana
sambanda
moorthy
Emergency
Medicine;
Epidemiology
and
Community
Medicine
University
of Ottawa;
Ottawa
Hospital
Research
Institute
Syn
T2
P2, P3
95%
0%
5%
245,798
251,268
233,278
515,115
504,665
458,918
Ratika
Parkash
Medicine
Dalhousie SCD, AF,
T2, T3
University
Syn
P2, P3
70%
20%
10%
165,650
65,550
0
482,543
132,300
0
Allan
Skanes
Medicine
WesternUniversity
Hospital
AF
T1
P1, P2
50%
40%
10%
246,900
249,300
0
860,800
193,500
0
Jason
Andrade
Medicine
UBC
AF
T2, T3
P2, P3
60%
20%
20%
271,708
178,354
0 1,077,500
589,500
0
Medicine
University
of British SCD, Syn T1, T2
Columbia
P2, P3
50%
10%
40%
124,289
124,876
0
184,500
0
1,179,339
994,283
233,278 3,251,708 1,751,954
458,918
86.2
15-P10-001
85.6
15-P05-001
80.6
15-P06-001
74.6
15-P15-001
71.4
The Canadian Genetic Heart
Rhythm (CGHR) Network:
Innovative Strategies to
Andrew
15-P09-001 Reduce the Risk of Sudden
Krahn
Cardiac Death Using Novel
Clinical and Population
Approaches
Total CANet 2,406,900
170,500
Total Cash/inkind 5,462,580
15-P01-001 - Assessment of Norepinephrine Transport Inhibition to Prevent Recurrent Vasovagal
Syncope (POST ATOM)
NPI: Robert Sheldon (University of Calgary, Alberta)
The objective of this program is to develop an effective medical therapy that is appropriate and
acceptable to patients and that reduces the burden of recurrent vasovagal syncope and restores quality
of life in patients and the health care system. Over 50% of Canadians faint, and at least half faint
repeatedly. Most Syncope patients seen in referral clinics faint repeatedly; in the Calgary Syncope Clinic
the median number of lifetime faints is 10-15. Most patients have trauma associated with syncope
ranging from bruises to fractures and head injuries. Patients with frequent syncope have a markedly
reduced quality of life. Syncope has a heavy impact on the health care system. It causes 1-3% of
emergency department admissions, and of these 43% have vasovagal syncope (VVS). In the US over
$2.4 billion is spent yearly in hospitals caring for patients with syncope.
THE PROJECT: This multicenter randomized, placebo-controlled, pilot study will determine if
atomoxetine can prevent hypotension due to the vasovagal reflex induced by head-up tilt testing. 74
subjects with VVS within the previous year will be treated with either atomoxetine or placebo the night
before and the morning of tilt table testing. Key physiological variables such as beat-to-beat blood
pressure will be measured and analyzed.
The project will also determine:
1. the patient-defined Minimal Clinically Important Difference (MCID) for pharmacologic treatment
of VVS as well as the patient-defined balance among drug efficacy, side effects, and dosage
frequency. This project will be conducted by patient engagement researchers within the PaCER
program and include qualitative research methods such as patient focus groups and surveys.
2. family physicians, general internists, cardiologists, and neurologists prescribing practices, and
the need and enthusiasm for a randomized trial.
IMPACT(S): The project seeks to:
 determine if atomoxetine is an effective drug therapy for vasovagal syncope;
 define patient-developed Minimal Clinically Important Difference for drug treatment of
vasovagal syncope.
FUTURE PROJECTS
Project 2.1 Pivotal Randomized clinical trial to test the hypothesis that atomoxetine prevents
recurrences of VVS in patients with at least moderately severe VVS.
Project 2.2 As part of the clinical trial, economic, health care utilization and quality of life data will be
collected and used to develop a decision analytic framework to model the impact of
atomoxetine therapy and its cost/outcome implications.
Project 3.1 survey family physicians, internists, cardiologists, and neurologists concerning their
prescribing practices, barriers to prescriber change, and how they might use the results of
the randomized trial. These data will help shape a physician-oriented knowledge
mobilization program.
Project 4.1 Assessment of prescribing practice, implementation and impact on the health care system.
15-P10-001 - Validation and Implementation of the Canadian Syncope Risk Scale for Risk-Stratification
of Syncope Patients in the Emergency Department
NPI: Venkatesh Thiruganasambandamoorthy (University of Ottawa, Ontario)
The overall objective of this program is to optimize the management of syncope patients by:
i) Accurate Emergency Department (ED) risk-stratification for early disposition of the very low-risk
and low-risk patients, and out-of-hospital monitoring for those at risk for arrhythmia;
ii) Diversion of the very low-risk patients to the ‘Rapid Referral Syncope Clinics’ at the community
level by Emergency Medical Services (EMS); and,
iii) Self-identification of risk by patients with recurrent syncope at home.
Syncope (commonly known as fainting) is a common condition that affects one-third of the population
at least once during their life-time. Among those who suffer syncope, one-third will suffer it repeatedly.
Syncope can be caused by serious underlying conditions such as irregular heart rhythm or blood clots in
the lung. Many of these serious conditions will lead to deaths if not properly identified and treated.
However, the majority (90%) do not have any serious underlying conditions. Because of the dramatic
nature of the condition, two-thirds of all patients will arrive to the hospital by ambulance costing the
health care system (estimated 100,000 ED visits per year due to syncope). The risk of serious underlying
conditions in most patients (75%) is either very-low (0.4%), or low (1-2%). Hence, they do not need
extensive ED investigations or hospitalization.
THE PROJECT: The objective of this project is to standardize ED management, and identify the very lowrisk and low-risk syncope patients for early disposition. The project will validate (9 site prospective
observational cohort study) and implement (16 site matched-pair cluster design study) the Canadian
Syncope Risk Scale and derive and validate two risk-tools:
1) Canadian Syncope Arrhythmia Risk Tool - to identify those at-risk for 30-day arrhythmia or death;
2) Syncope CT Head Tool - to appropriately identify those who need a CT head scan for identification of
serious intracranial abnormalities and reduce overuse of this test.
IMPACT: The program will deliver better and safer healthcare at a lower cost. The program will improve
syncope care at all levels (patients, community, EMS, hospital EDs; patient and health system levels);
decrease healthcare costs; decrease EMS burden; reduce ED and hospital overcrowding by decreasing
unnecessary ED visits and hospitalization; improve patient satisfaction (lesser burden due to long-wait
times and hospitalization); and empower patients by more self-care of the condition. The clinical
decision aids will likely reduce morbidity and mortality. Use of technology (live monitoring and digital
applications) will lead to industrial development and job creation. These technologies can be applied to
other disease conditions and hence, marketed for other commercial benefits.
FUTURE PROJECTS
Project 2 This project will exploit the live cardiac monitoring technology to reducing hospitalizations.
Once the Canadian Syncope Arrhythmia Risk Tool has been validated in Project 1, an OOH
monitoring protocol will be developed for at-risk patients and tested.
Project 3 This project will derive, Validate, and Implement a Clinical Decision Aid (CDA) to identify the
very low-risk syncope patients who can be diverted to ‘Rapid Referral Syncope Clinics’ to
reduce EMS burden and ED overcrowding.
Project 4 This project will empower patients by developing a Patient Decision Tool (PDT) for selfidentification of risk and take appropriate action. While PDT will be very useful for patients
who suffer recurrent syncope, its usefulness among patients suffering their first episode of
syncope will also be assessed.
Project 5 This project will disseminate the Canadian Syncope Risk Scale, the Canadian Syncope
Arrhythmia Risk Tool and the out-of-hospital monitoring protocol. The project will focus on
the dissemination and implementation of the Arrhythmia Risk Tool in centers where remote
monitoring technology is not available. With the aid of KT experts and technology companies,
we will undertake widespread dissemination by digital application development and
marketing. During this project, we w
15-P05-001 - Remote patient management for Cardiac Implantable Electronic Devices (RPM-CIED)
NPI: Ratika Parkash (Dalhousie University, Nova Scotia)
The overall objective of this program is to assess barriers to, and evaluate and implement a patientoriented CIED management model incorporating advanced remote management (remote monitoring
(RM) and remote programming (RP)) to promote a paradigm shift to patient-centered care, resulting in
new practice guidelines for management of this population.
There are currently 120 000 Canadians living with either a pacemaker or implantable defibrillator (ICD).
Pacemakers are placed into the chest of a patient who needs their heartbeat to be supported. ICDs are
devices that can deliver a life-saving shock to someone who already has had a dangerous heart rhythm,
or is at risk of developing one. All of these devices need to be followed on a regular basis by physicians,
nurses or technicians who understand how they work so that the chance of malfunction is very low. As
these devices are machines, they are also prone to recall and may require close monitoring to avoid the
risk of malfunction. Currently, patients who have these devices are required to visit a clinic at least
twice a year, sometimes more frequently if their device has been recalled or if other problems are
experienced, such as a shock from their ICD, which occurs infrequently but requires urgent assessment.
Technology is now available to completely remove the need for patients to travel outside of their local
community to receive care from a highly specialized device center.
THE PROJECT: This project will be conducted in two parts: Part A will be a survey of CIED follow-up
clinics to determine current status regarding delivery of CIED care, reimbursement models and clinic
funding. The results of the survey will be analysed and designed to deliver high-quality, timely and
accessible evidence that would be used by senior government policy decision makers. A one-day, in
camera meeting for decision makers and researchers will be held to present the evidence on remote
CIED patient management. Part B of the project will be an observational study to assess generalizability,
uptake, and patient/physician compliance with RPM-CIED and to evaluate the feasibility and cost of this
system.
THE IMPACT: This study will:
 drive health system cost-savings resulting from a reduction in both inpatient and outpatient
clinical services, potential reduction in stroke and sudden death through early detection of atrial
fibrillation and ventricular arrhythmias;
 drive uniform delivery of CIED care in terms of access and quality of services delivered,
regardless of geographical location, across Canada;
 Improve the quality of life of patients with CIEDs and caregivers;
 reduce travel and wait times thus improving timely access to care;
 reduce the need for clinical specialists in all jurisdictions, where technical support may be
provided as easily from a remote location, with this technology.
FUTURE PROJECTS:
Project 2 A parallel, randomized trial to assess the clinical benefit of remote patient management as
compared to routine device follow-up.
Project 3 Establishing an implementation framework to increase the use of remote patient
management throughout all device follow-up centers in Canada. The findings will be
implemented into new guidelines for device follow-up including remote patient
management.
15-P06-001 - Atrial Image-guided Decision to Optimize Treatment of Atrial Fibrillation (AID-AF)
NPI: Frank Prato (Western University, Ontario)
The overall objective of this program is to develop, validate and implement an image-guided decision
tool to optimize patient selection for AF ablation, resulting in substantial reductions in AF-related
hospitalization and emergency department visits, while maintaining high quality of life for all AF
patients.
Atrial fibrillation, often called AF, causes the heart to beat rapidly and irregularly and frequently causes
symptoms such as chest pain, shortness of breath, light-headedness and palpitations until it either stops
racing or is slowed by medications. Symptom severity often causes patients to go immediately to the
emergency department for treatment, including hospitalization. Because AF prevalence is increasing due
to the aging population, the costs to the healthcare system are significant – $815 million dollars in
Canada in 2010 alone. While drugs designed to keep patients in normal rhythm, called anti-arrhythmic
drugs, are available, they work poorly or are associated with significant adverse effects in some cases. A
relatively minimally invasive therapy, called catheter ablation, delivers treatment to the sources of AF to
prevent it from coming back. Studies have consistently shown that once a patient has failed an antiarrhythmic drug, ablation is far better at preventing future AF. Because of the good results, catheter
ablation has grown rapidly. Unfortunately, a first procedure works only 50-70% of the time and a second
procedure is common. Often this is easily treated by a short second procedure. In some patients
however, ablation fails to work regardless of the number of attempts because the heart is so severely
diseased. A decision tool to identify patients appropriate for ablation therapy would improve success
rate and reduce the risk of serious complications from repeat ablations.
THE PROJECT: using an established canine model of AF (N=14), the project will develop and validate the
use of simultaneous PET and MR imaging to establish histology-validated imaging metrics that can
accurately identify the severity of heart tissue diseased. This project will also include a human pilot
study of 75 consecutively referred patients for AF ablation recruited across in three sites across Canada
to undergoing similar imaging protocols.
THE IMPACT: The program will develop and incorporate novel, commercializable imaging technologies
into an evidence-based patient-directed decision tool to aid patients in decision-making about their AF
therapeutic choices. By predicting potential ablation outcomes, patients will be educated and
empowered to make informed decisions about alternative therapies and direct their care. By optimizing
patient selection in this way, outcomes of ablation will be improved, and recurrences reduced resulting
in reduced ED visits and hospitalizations.
FUTURE PROJECTS:
Project 2 Imaging metrics from project 1 and other useful clinical and echocardiographic parameters
will be collected from a cohort of 300 patients undergoing AF ablation. These data will be
correlated with results from implantable loop records one year after the last ablation to
develop a predictive decision tool. A second validation cohort of 200 patients undergoing
standard AF ablation will be assessed using the decision tool as developed above.
Project 3 A multicentre randomized clinical trial will test the decision tool in 400 patients who are
candidates for AF ablation. The primary outcome will be freedom from clinical and
electrocardiographic AF one year post ablation. Important secondary outcomes relevant to
the CANet goals include ED visits and AF-related hospitalizations.
15-P15-001 - Early Invasive vs. Delayed Intervention for Atrial Fibrillation
NPI: Jason Andrade (University of British Columbia, British Columbia)
The overall goal of this program is to determine whether early intervention with cryothermal ablation is
associated with significant (i.e. >20%) reduction in arrhythmia burden, AF symptoms, and healthcare
utilization.
Atrial fibrillation (AF) is a common heart rhythm disorder where, instead of a coordinated contraction,
the two upper chambers (atrium) of the heart quiver, causing a rapid, irregular heartbeat. It affects
quality of life and increases the risk of stroke and death. In most cases, abnormal electrical impulses that
set off AF come from the veins that carry blood from the lungs to the left upper chamber (atrium) of the
heart (the pulmonary veins). The current medications that we have to treat AF work by improving the
symptoms of AF but don’t treat the underlying disease. Catheter ablation, a procedure used to remove
faulty electrical pathways, has been developed to cure AF. The procedure involves placing a balloon
catheter into the upper left chamber of the heart via the veins in the groin and then freezing the heart
tissue responsible for AF. By freezing the heart to very low temperatures, the heart tissue responsible
for AF can be killed effectively removing the faulty electrical pathways and potentially curing the
arrhythmia.
THE PROJECT: This project is an international, multi-center Canadian-led randomized controlled trial of
300 patients comparing early (“first-line”) catheter-based pulmonary vein isolation (PVI) using
cryothermal energy to first-line anti-arrhythmic drug therapy on the clinical outcomes of reducing AF
recurrences, arrhythmia related symptoms, and hospitalisations.
THE IMPACT: This study has the potential to fundamentally change the way in which we approach early
atrial fibrillation, and in particular the application of catheter ablation procedures. On an individual level
early ablation may result in a reduction in AF recurrences, with subsequent improvement in arrhythmia
related symptoms, quality of life, exercise tolerance and functional capacity, physical health, mental
health, and work performance. On a system/societal level, this may result in reduced burden on health
system owing to reduced emergency room visits and hospitalisations, leading to an overall reduction in
health care utilization and days of work missed due to illness resulting in increased productivity (indirect
cost/economic benefit). There are additional impacts arising from the direct and measurable
employment and economic benefits to Canadians accruing from the Pointe-Claire CryoCath facility.
FUTURE PROJECTS:
Project 2 Quality of life analysis of an Early Invasive Management of Atrial Fibrillation. This project
encompasses a prospective health-related quality of life (HRQOL) analysis of the effect of
early (“first-line”) ablation vs. a delayed approach (“first-line” anti-arrhythmic drug therapy)
Project 3 Economic Analysis of an Early Invasive Management of Atrial Fibrillation. This project
encompasses two smaller projects centered on the cost-effectiveness of early (“first-line”)
ablation vs. a delayed approach (“first-line” anti-arrhythmic drug therapy)
Project 4 Patient Preferences and Values with respect to an Early Invasive Approach to the
Management of Atrial Fibrillation. This project is a multicenter survey of patients’ attitudes
and preferences with respect to the various treatment options for atrial fibrillation. It
encompasses an online or face-to-face survey of patients and physicians (general
practitioners, internal medicine specialists, and cardiologists).
15-P09-001 - The Canadian Genetic Heart Rhythm (CGHR) Network: Innovative Strategies to Reduce
the Risk of Sudden Cardiac Death Using Novel Clinical and Population Approaches
NPI: Andrew Krahn (University of British Columbia, British Columbia)
Robert Hamilton (University of Toronto, Ontario)
The overall goal of the program is to engage those known to be at risk, identify new patients that are at
risk, understand their values and preferences, and develop detection and prevention strategies.
Thirty-thousand Canadians die suddenly every year. Sudden cardiac death (SCD), especially in the young,
is a catastrophic event that can be caused by abnormal electrical or muscle changes in the heart, which
are often not recognized until someone’s heart stops and tests are done. The consequences can be
devastating to affected families and care givers. SCD can strike people of all ages, including young
people. Family members of victims of SCD can be at risk for having the same event due to their genes.
Unfortunately, the Canadian health care system typicaly picks up only 10% of the individuals with
genetic risks of SCD. Other countries, such as New Zealand and Sweden, have effectively utilized
consent-based clinical registries for patients, supported by genetic counselling resources, to cascade
screen families of probands, increasing disease ascertainment to 38-55% of the estimated disease
population.
The goal of the Canadian Genetic Heart Rhythm (CGHR) Network is to harness the expertise available
across Canada to develop a strategy that will prevent deaths from SCD. It is a unique opportunity to
connect patients and their family members, health policy decision-makers, collaborators from medical
industry, and health care providers to work together to help reverse the tide of the ravaging effects of
SCD.
THE PROJECT: Phase 1: Detection of at-risk individuals with unrecognized inherited channelopathies,
hypertrophic and arrhythmogenic cardiomyopathy in the community through an active multidisciplinary
program to screen and identify disease in family members of probands with these disorders. Individuals
who test positive will undergo a standardized phenotype assessment that will include novel risk marker
analysis coupled with lifestyle, medical/surgical interventions commensurate with the risk assessment.
With consent, email-delivered patient questionnaires will be used to expand family pedigrees and obtain
disease-related data for risk factor analysis. Phase 2 of the project will include involve monitoring of high
risk individuals identified in phase I using an implanted cardiac monitor (ICM) to identify asymptomatic
non-sustained arrhythmias or symptom-related rhythms.
THE IMPACT: The impact of sudden cardiac death (SCD) is second only to all cancers in terms of lifeyears lost. Among the causes of SCD, cardiac channelopathies and hereditary cardiomyopathies are the
predominant causes of SCD in young adults and children, and this contributes disproportionately to lifeyears lost. Although these conditions are individually rare or uncommon, when taken together it is
estimated that 1 in 300 individuals are at risk.
FUTURE PROJECTS:
Part 1a Understanding patient perspectives to develop easily accessible roadmaps for the patient/family
journey and resources for educating willing and reluctant family members to the value of
cascade screening. The study will use a mixed methods design involving interviews of at-risk
individuals and three focus groups. This will lead to the development of robust education,
awareness and decision-making tools regarding cascade screen and long term cardiac
monitoring.
Part 1b The CGHR Network will develop a systematic and cost-effective screening program of family
members at risk for SCD that can be implemented in large scale, with strategies that focus
specifically on family’s priorities and needs.
Part 2 A study of the patients’ journey in the CGHR Network. The study aims to understand the barriers
and facilitators of care provided in the CGHR Network and to implement quality improvement
and knowledge translation cycles. The methodological approach will be tailored to each
research question and employ both qualitative and quantitative methods as appropriate.
Part 3 Sudden Cardiac Death awareness initiatives including partnerships with stakeholders throughout
the health system (primary care physicians, first responder and emergency services, rural and
remote providers including telehealth networks, coroners). For example, a partnership will be
initiated through the Base Hospital Medical Director’s as they set the standard of practice for
Paramedics. There is potential with EMS to collect and study ECG data as well as Electronic Call
Records (ECR’s) for all patients with syncope, seizures and cardiac arrest (SCD warning signs).
Part 4 Public advocacy and screening including use of traditional and social media, education toolkit for
public employees (schools, sports organizations), promotion of fainting awareness policy and
legislation. In Ontario, our research proposal can have a symbiotic relationship with the
proposed fainting legislation - Ontario fainting awareness legislation (PACED)
Part 5a Strategic planning for genotype risk marker project (Genome BC and Canada, provincial ECG and
blood labs, patient and ethics representatives, Ministry of health representatives, translational
genetics experts).
Part 5b Health System Improvement: Inherited Arrhythmia Clinics and risk marker development
(economic analysis, gene and gene marker discovery, and founder risk marker studies, novel ECG
and monitoring technology). These projects will help to influence government policy for the
planning of health services, focusing on a “personalized medicine” approach that includes
genetic testing and screening to ensure that people are offered the right treatment at the right
time to prevent SCD.