Publications by authors named "George Wells"

677 Publications

PRIME-IPD SERIES Part 1. The PRIME-IPD tool promoted verification and standardization of study datasets retrieved for IPD meta-analysis.

J Clin Epidemiol 2021 May 24. Epub 2021 May 24.

School of Epidemiology and Public Health, University of Ottawa, 600 Peter Morand Crescent, Ottawa, Ontario, K1G 5Z3, Canada; Cardiovascular Research Methods, University of Ottawa Heart Institute, 40 Ruskin St, Ottawa, Ontario, K1Y 4W7, Canada. Electronic address:

Objective: We describe a systematic approach to preparing data in the conduct of Individual Participant Data (IPD) analysis.

Study Design And Setting: A guidance paper proposing methods for preparing individual participant data for meta-analysis from multiple study sources, developed by consultation of relevant guidance and experts in IPD. We present an example of how these steps were applied in checking data for our own IPD meta analysis (IPD-MA).

Results: We propose five steps of Processing, Replication, Imputation, Merging, and Evaluation to prepare individual participant data for meta-analysis (PRIME-IPD). Using our own IPD-MA as an exemplar, we found that this approach identified missing variables and potential inconsistencies in the data, facilitated the standardization of indicators across studies, confirmed that the correct data were received from investigators, and resulted in a single, verified dataset for IPD-MA.

Conclusion: The PRIME-IPD approach can assist researchers to systematically prepare, manage and conduct important quality checks on IPD from multiple studies for meta-analyses. Further testing of this framework in IPD-MA would be useful to refine these steps.
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http://dx.doi.org/10.1016/j.jclinepi.2021.05.007DOI Listing
May 2021

Protocol for a randomised controlled trial for Treatment in Thoracic Aortic Aneurysm: Surgery versus Surveillance (TITAN: SvS).

BMJ Open 2021 05 26;11(5):e052070. Epub 2021 May 26.

Cardiac Surgery, University of Ottawa Heart Institute, Ottawa, Ontario, Canada

Introduction: Ascending thoracic aortic aneurysm (ATAA) is an asymptomatic condition that can lead to catastrophic events of rupture or dissection. Current guidelines are based on limited retrospective data and recommend surgical intervention for ATAA with a diameter of greater or equal to 5.5 cm. Treatment in Thoracic Aortic Aneurysm: Surgery versus Surveillance is the first prospective, multicentre, randomised controlled trial that compares outcomes of patients undergoing early elective ascending aortic surgery to patients undergoing medical surveillance.

Methods And Analysis: Patients between the ages of 18 and 80 with an asymptomatic ATAA between 5.0 cm and 5.4 cm in diameter are eligible for randomisation to early surgery or surveillance. Patients in the surgery group will be followed at 1 month after discharge, then annually for a minimum of 2 years and up to 5 years. Patients in the surveillance group will be followed annually from their index clinic visit for a minimum of 2 years and up to 5 years. The primary outcome is all-cause mortality at follow-up. A sample size of 618 subjects (309 in each group) will achieve an 80% power at a 0.047 significance level.

Ethics And Dissemination: This study has received Ottawa Health Science Network Research Ethics Board approval (Protocol 20180007-01H), which was most recently updated on 25 November 2020. The Research Ethics Board have granted approval to the study at 14 participating institutions, including the Ottawa Health Science Network Research Ethics Board. On completion of data analysis, the result of the trial will be presented at national and international conferences, and published in relevant journals, regardless of the finding of the trial.

Trial Registration Number: NCT03536312.
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http://dx.doi.org/10.1136/bmjopen-2021-052070DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8160193PMC
May 2021

Role of air scouring in anaerobic/anoxic tanks providing nitrogen removal by mainstream anammox conversion in a hybrid biofilm/suspended growth full-scale WWTP in China.

Water Environ Res 2021 May 26. Epub 2021 May 26.

Xi'an Wastewater Treatment Co. Ltd, Xi'an, 710077.

A full-scale wastewater treatment plant in China experienced unintentional anammox bacteria enrichment on biofilm carriers placed in the anaerobic and anoxic zones of an anaerobic/anoxic/oxic process under ambient temperatures and without bioaugmentation. Here we show that microaerophilic conditions resulting from air scouring needed for biofilm carriers suspension in the anaerobic/anoxic zones can support a robust nitritation/anammox process. Results from an in-situ on/off air scouring test showed that air scouring strongly induced both ammonia and total inorganic nitrogen removal in the anaerobic/anoxic zones. Ammonium concentration in the anaerobic and anoxic tanks remained constant or even slightly increased when air scouring was off, indicating that air scouring made a noticeable difference in nitrogen profiles in the anaerobic/anoxic zones. Various batch tests further indicated that partial denitrification is not likely to generate nitrite for anammox bacteria. Robust nitritation, and anammox on the carriers, can occur at low dissolved oxygen conditions, as measured in the full-scale facility. The observations show that mainstream deammonification without sidestream bioaugmentation at moderate temperature is feasible and further optimization by a more dedicated design can result in improved nitrogen removal in cases when chemical oxygen demand is limited in mainstream wastewater treatment.
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http://dx.doi.org/10.1002/wer.1592DOI Listing
May 2021

Protocol for the Acute Myocardial Infarction Study in Northeastern China (AMINoC): a real-world prospective cohort study.

BMJ Open 2021 05 25;11(5):e042936. Epub 2021 May 25.

Department of Cardiology, the Second Hospital of Jilin University, Changchun, Jilin, China

Introduction: Acute myocardial infarction (AMI) has become one of the major causes of mortality and morbidity in China. However, little is known about the characteristics, medical care and outcomes of patients with AMI in Northeastern China. The Acute Myocardial Infarction Study in Northeastern China (AMINoC) is aimed at obtaining timely real-world knowledge in terms of characteristics, clinical care and outcomes of patients with AMI and at providing care-quality improvement efforts in Northeastern China.

Methods And Analysis: The AMINoC is a real-world, prospective, multicentre cohort study. The study selected 20 hospitals using stratified cluster sampling from different levels of hospitals among nine districts throughout Jilin Province. Hospitalised patients with a primary diagnosis of AMI in each site are consecutively enrolled for 1 year. Demographic characteristics, clinical data, treatments, outcomes and cost are collected by local investigators. Patient follow-up after discharge is planned for up to 2 years.

Ethics And Dissemination: The protocol has been approved by the ethics committee at the Second Hospital of Jilin University. The findings of this study will be published in peer-reviewed journals and medical conferences.

Trial Registration: NCT04451967.
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http://dx.doi.org/10.1136/bmjopen-2020-042936DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8154984PMC
May 2021

Remote Monitoring of Cardiovascular Implantable Electronic Devices in Canada: Survey of Patients and Device Health Care Professionals.

CJC Open 2021 Apr 20;3(4):391-399. Epub 2020 Nov 20.

Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.

Background: Remote monitoring is used to supplement in-clinic follow-up for patients with cardiac implantable electronic devices (CIEDs) every 6-12 months. There is a need to optimize remote management for CIEDs because of the consistent increases in CIED implants over the past decade. The objective of this study was to investigate real and perceived barriers to the use of remote patient management strategies in Canada and to better understand how remote models of care can be optimized.

Methods: We surveyed 512 CIED patients and practitioners in 22 device clinics in Canada.

Results: Device clinic surveys highlighted significant variation and inconsistency in follow-up care for in-clinic and remote visits across and within clinics. This survey showed that funding policies and management of additional workflow are barriers to optimal use and uptake. Despite this, device clinics perceive remote follow-up as a valuable resource and an efficient way to manage patient follow-up. Patients were broadly satisfied with their CIED follow-up care but identified barriers related to coordination of care, visit logistics, and information needs. Views varied as a function of clinical or sociodemographic characteristics. Most patients (n = 228; 91%) expressed a desire to receive a phone call from their device clinic after a remote transmission has been received.

Conclusions: Lack of a unified, guideline-supported approach to follow-up after CIED implant, and discrepant funding policies across jurisdictions, are significant barriers to the use of remote patient management strategies in Canada. Efforts to increase or expand use of remote follow-up must recognize these barriers and the needs of specific subgroups of patients.
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http://dx.doi.org/10.1016/j.cjco.2020.11.010DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8129436PMC
April 2021

PRIME-IPD SERIES Part 3. The PRIME-IPD tool fills a gap in guidance for preparing IPD for analysis.

J Clin Epidemiol 2021 May 15. Epub 2021 May 15.

School of Epidemiology and Public Health, University of Ottawa, 600 Peter Morand Crescent, Ottawa, Ontario, K1G 5Z3, Canada; Cardiovascular Research Methods, University of Ottawa Heart Institute, 40 Ruskin St, Ottawa, Ontario, K1Y 4W7, Canada.

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http://dx.doi.org/10.1016/j.jclinepi.2021.05.001DOI Listing
May 2021

Cognitive dysfunction after out-of-hospital cardiac arrest: Rate of impairment and clinical predictors.

Resuscitation 2021 May 12. Epub 2021 May 12.

Division of Cardiac Prevention and Rehabilitation, University of Ottawa Heart Institute, Ottawa, Canada; School of Psychology, University of Ottawa, Ottawa, Canada. Electronic address:

Background: The purpose of this study was to evaluate the rate and domains of cognitive impairment in out-of-hospital cardiac arrest (OHCA) survivors, as compared to patients who experienced a myocardial infarction (MI), and to explore mechanisms and predictors of this impairment.

Methods And Results: OHCA survivors with "good" neurological recovery (i.e., Cerebral Performance Categories Scale ≤ 2) (n = 79), as well as a control group of MI patients (n = 69), underwent a comprehensive neuropsychological assessment. Forty-three percent of OHCA survivors were cognitively impaired (in the lowest decile on a global measure of cognitive functioning). Rates of impairment were approximately six times higher in the OHCA group than the MI group. Attention, memory, language and executive function were affected. Downtime was a significant predictor of cognitive impairment; the interaction between downtime and immediate intervention was significant such that, at short downtimes, receiving cardiopulmonary resuscitation (CPR) or defibrillation within 1 min of collapse predicted less cognitive impairment.

Conclusions: OHCA survivors - even those with seemingly good neurological recovery - are at risk for cognitive impairment. Cognitive rehabilitation may be an important consideration post-OHCA.
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http://dx.doi.org/10.1016/j.resuscitation.2021.05.002DOI Listing
May 2021

Insights into Nitrous Oxide Mitigation Strategies in Wastewater Treatment and Challenges for Wider Implementation.

Environ Sci Technol 2021 Jun 12;55(11):7208-7224. Epub 2021 May 12.

School of Chemical Engineering, the University of Queensland, St. Lucia, Queensland 4072, Australia.

Nitrous oxide (NO) emissions account for the majority of the carbon footprint of wastewater treatment plants (WWTPs). Many NO mitigation strategies have since been developed while a holistic view is still missing. This article reviews the state-of-the-art of NO mitigation studies in wastewater treatment. Through analyzing existing studies, this article presents the essential knowledge to guide NO mitigations, and the logics behind mitigation strategies. In practice, mitigations are mainly carried out by aeration control, feed scheme optimization, and process optimization. Despite increasingly more studies, real implementation remains rare, which is a combined result of unclear climate change policies/incentives, as well as technical challenges. Five critical technical challenges, as well as opportunities, of NO mitigations were identified. It is proposed that (i) quantification methods for overall NO emissions and pathway contributions need improvement; (ii) a reliable while straightforward mathematical model is required to quantify benefits and compare mitigation strategies; (iii) tailored risk assessment needs to be conducted for WWTPs, in which more long-term full-scale trials of NO mitigation are urgently needed to enable robust assessments of the resulting operational costs and impact on nutrient removal performance; (iv) current mitigation strategies focus on centralized WWTPs, more investigations are warranted for decentralised systems, especially decentralized activated sludge WWTPs; and (v) NO may be mitigated by adopting novel strategies promoting NO reduction denitrification or microorganisms that emit less NO. Overall, we conclude NO mitigation research is reaching a maturity while challenges still exist for a wider implementation, especially in relation to the reliability of NO mitigation strategies and potential risks to nutrient removal performances of WWTPs.
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http://dx.doi.org/10.1021/acs.est.1c00840DOI Listing
June 2021

A randomized, controlled comparison of electrical versus pharmacological cardioversion for emergency department patients with acute atrial flutter.

CJEM 2021 May 18;23(3):314-324. Epub 2021 Jan 18.

Department of Emergency Medicine, University of Ottawa, Ottawa, ON, Canada.

Background: Acute atrial flutter has one-tenth the prevalence of acute atrial fibrillation in the emergency department (ED) but shares many management strategies. Our aim was to compare conversion from acute atrial flutter to sinus rhythm between pharmacological cardioversion followed by electrical cardioversion (Drug-Shock), and electrical cardioversion alone (Shock-Only).

Methods: We conducted a randomized, blinded, placebo-controlled comparison of attempted pharmacological cardioversion with IV procainamide followed by electrical cardioversion if necessary, and placebo infusion followed by electrical cardioversion. We enrolled stable patients with a primary diagnosis of acute acute atrial flutter at 11 academic EDs. The primary outcome was conversion to normal sinus rhythm.

Findings: From July 2013 to October 2018, we enrolled 76 patients, and none were lost to follow-up. Comparing the Drug-Shock to the Shock-Only group, conversion to sinus rhythm occurred in 33 (100%) versus 40 (93%) (absolute difference 7.0%; 95% CI - 0.6 to 14.6; P = 0.25). Median time to conversion from start of infusion in the Drug-Shock group was 24 min (IQR 21-82) but only 9 (27%) cases were converted with IV procainamide. Patients in both groups had similar outcomes at 14 days; there were no strokes or deaths.

Interpretation: This trial found that the Drug-Shock strategy is potentially superior but that either approach to immediate rhythm control in the ED for patients with acute acute atrial flutter is highly effective, rapid, and safe in restoring sinus rhythm and allowing patients to go home and return to normal activities. Unlike the case of atrial fibrillation, we found that IV procainamide alone was infrequently effective.
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http://dx.doi.org/10.1007/s43678-020-00067-7DOI Listing
May 2021

Response to Poitrasson-Rivière and Murthy.

J Nucl Cardiol 2021 May 4. Epub 2021 May 4.

Cardiac Imaging, University of Ottawa Heart Institute, Ottawa, ON, Canada.

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http://dx.doi.org/10.1007/s12350-021-02639-1DOI Listing
May 2021

OMERACT consensus-based operational definition of contextual factors in rheumatology clinical trials: A mixed methods study.

Semin Arthritis Rheum 2021 Jun 2;51(3):601-606. Epub 2021 Apr 2.

Section for Biostatistics and Evidence-Based Research, The Parker Institute, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark; Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Odense, Denmark. Electronic address:

Objectives: To develop an operational definition of contextual factors (CF) [1].

Methods: Based on previously conducted interviews, we presented three CF types in a Delphi survey; Effect Modifying -, Outcome Influencing - and Measurement Affecting CFs. Subsequently, a virtual Special Interest Group (SIG) session was held for in depth discussion of Effect Modifying CFs.

Results: Of 161 Delphi participants, 129 (80%) completed both rounds. After two rounds, we reached consensus (≥70% agreeing) for all but two statements. The 45 SIG participants were broadly supportive.

Conclusion: Through consensus we developed an operational definition of CFs, which was well received by OMERACT members.
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http://dx.doi.org/10.1016/j.semarthrit.2021.03.013DOI Listing
June 2021

On the roles of reproducibility, ethics, and statistical modeling in medical research.

J Nucl Cardiol 2021 Apr 13. Epub 2021 Apr 13.

Cardiac Imaging, University of Ottawa Heart Institute, Ottawa, Canada.

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http://dx.doi.org/10.1007/s12350-021-02592-zDOI Listing
April 2021

Defining idiopathic ventricular fibrillation: A systematic review of diagnostic testing yield in apparently unexplained cardiac arrest.

Heart Rhythm 2021 Mar 26. Epub 2021 Mar 26.

Center for Cardiovascular Innovation, Division of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada. Electronic address:

Background: Idiopathic ventricular fibrillation (IVF) is diagnosed in patients with apparently unexplained cardiac arrest (UCA) after varying degrees of evaluation. This is largely due to the lack of a standardized approach to UCA.

Objective: We sought to develop an evidence-based diagnostic algorithm for IVF by systematically examining the yield of diagnostic testing in UCA probands.

Methods: Studies reporting the yield of diagnostic testing in UCA were identified in MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, and conference abstracts. Their methodological quality was assessed by the National Institutes of Health quality assessment tool. Meta-analyses were performed using the random effects model.

Results: A total of 21 studies were included. The pooled comprehensive diagnostic testing yield was 43% (95% confidence interval 39%-48%). A lower yield was seen when only definite diagnoses based on the prespecified criteria were used (32% vs 47%; P = .15). Epinephrine challenge, Holter monitoring, and family screening were associated with low yield (<5%), whereas cardiac magnetic resonance imaging, exercise treadmill test, and sodium-channel blocker challenge were associated with high yield (≥5%). Coronary spasm provocation, electrophysiology study, and systematic genetic testing were reported to be abnormal in a high proportion of UCA probands (>10%).

Conclusion: We developed a stepwise algorithm for UCA evaluation and criteria to assess the strength of IVF diagnosis on the basis of the diagnostic yield of UCA testing.
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http://dx.doi.org/10.1016/j.hrthm.2021.03.030DOI Listing
March 2021

Central Hypertension in Patients With Thoracic Aortic Aneurysms: Prevalence and Association With Aneurysm Size and Growth.

Am J Hypertens 2021 Mar 24. Epub 2021 Mar 24.

The Department of Medicine, Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.

Background: Hypertension (HTN) has the greatest population-attributable risk for aortic dissection and is highly prevalent among patients with thoracic aortic aneurysms (TAAs). Although HTN is diagnosed based on brachial blood pressure (bBP), central HTN (central systolic blood pressure [cSBP] ≥130 mm Hg) is of interest as it better reflects blood pressure (BP) in the aorta. We aimed to (i) evaluate the prevalence of central HTN among TAA patients without a diagnosis of HTN, and (ii) assess associations of bBP vs. central blood pressure (cBP) with aneurysm size and growth.

Methods: One hundred and five unoperated subjects with TAAs were recruited. With validated methodology, cBP was assessed with applanation tonometry. Aneurysm size was assessed at baseline and follow-up using imaging modalities. Aneurysm growth rate was calculated in mm/year. Multivariable linear regression adjusted for potential confounders assessed associations of bBP and cBP with aneurysm size and growth.

Results: Seventy-seven percent of participants were men and 49% carried a diagnosis of HTN. Among participants without diagnosis of HTN, 15% had central HTN despite normal bBP ("occult central HTN"). In these patients, higher central systolic BP (cSBP) and central pulse pressure (cPP) were independently associated with larger aneurysm size (β ± SE = 0.28 ± 0.11, P = 0.014 and cPP = 0.30 ± 0.11, P = 0.010, respectively) and future aneurysm growth (β ± SE = 0.022 ± 0.008, P = 0.013 and 0.024 ± 0.009, P = 0.008, respectively) while bBP was not (P > 0.05).

Conclusions: In patients with TAAs without a diagnosis of HTN, central HTN is prevalent, and higher cBP is associated with larger aneurysms and faster aneurysm growth.
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http://dx.doi.org/10.1093/ajh/hpaa183DOI Listing
March 2021

Interdepartmental program to improve outcomes for acute heart failure patients seen in the emergency department.

CJEM 2021 Mar 4;23(2):169-179. Epub 2021 Jan 4.

Department of Emergency Medicine, University of Ottawa, Ottawa, ON, Canada.

Introduction: Acute heart failure patients often have an uncertain or delayed follow-up after discharge from the ED. Our goal was to introduce rapid-access specialty clinics to ensure acute heart failure patients were seen within 7 days, in an effort to reduce admissions and improve follow-up care.

Methods: This prospective cohort study was conducted at two campuses of a large tertiary care hospital. We enrolled acute heart failure patients who presented to the ED with shortness of breath and were later discharged. Following a 12-month before period, we introduced rapid-access acute heart failure clinics staffed by cardiology and internal medicine. We allowed for a 3-month implementation period and then observed outcomes over the subsequent 12-month after period. The primary outcome was hospital admission within 30 days. Secondary outcomes included mortality and actual access to specialty care.

Results: Patients in the before (N = 355) and after periods (N = 374) were similar for age and most characteristics. Segmented autoregression analysis demonstrated there was a pre-existing trend to fewer admissions. Attendance at a specialty clinic increased from 17.8 to 42.1% (P < 0.01) and the median days to the clinic decreased from 13 to 6 days (P < 0.01). 30-days mortality did not change.

Conclusion: Implementation of rapid-access clinics for acute heart failure patients discharged from the ED did not lead to an overall decrease in hospital admissions. It did, however, lead to increased access to specialist care, reduced follow-up times, without an increase in return ED visits or mortality. Widespread use of this rapid-access approach to a specialist can improve care for acute heart failure patients discharged home from the ED.
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http://dx.doi.org/10.1007/s43678-020-00047-xDOI Listing
March 2021

Transradial Versus Transfemoral Access for Percutaneous Coronary Intervention in ST-Segment-Elevation Myocardial Infarction: A Systematic Review and Meta-Analysis.

Circ Cardiovasc Interv 2021 Mar 9;14(3):e009994. Epub 2021 Mar 9.

CAPITAL Research Group, Division of Cardiology, Department of Medicine (P.D.S., T.S., R.G.J., F.D.R., P.B., J.A.M., S.P., J.J.R., A.-Y.C., M.F., D.Y.S., A.D., C.G., M.L., B.H., M.L.M.), University of Ottawa Heart Institute, Ottawa, Canada.

[Figure: see text].
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.120.009994DOI Listing
March 2021

The Continued Need for Transparent Evidence on the Cost Effectiveness of Drugs for Rare Diseases.

Pharmacoeconomics 2021 Apr 6;39(4):479-480. Epub 2021 Mar 6.

School of Epidemiology and Public Health, University of Ottawa, 600 Peter Morand Crescent, Ottawa, ON, K1G 5Z3, Canada.

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http://dx.doi.org/10.1007/s40273-021-01007-8DOI Listing
April 2021

Canadian Registry of Electronic Device Outcomes: remote monitoring outcomes in the Abbott battery performance alert-a multicentre cohort.

Europace 2021 Feb 20. Epub 2021 Feb 20.

Department of Medicine, Division of Cardiology, QEII Health Sciences Center, Halifax Infirmary Site, 796 Summer Street, Room 2501D, Halifax NS B3H 3A7, Canada.

Aims: Cardiac implantable electronic devices with device advisories have the potential of device malfunction. Remote monitoring (RM) of devices has been suggested to allow the identification of abnormal device performance and permit early intervention. We sought to describe the outcomes of patients with and without RM in devices subject to the Abbott Premature Battery Depletion (PBD) advisory with data from a Canadian registry.

Methods And Results: Patients with an Abbott device subject to the PBD advisory from nine implantable cardioverter defibrillator (ICD) implanting centres in Canada were included in the registry. The use of RM was identified from baseline and follow-up data in the registry. The primary outcome was detection of PBD and all-cause mortality. A total of 2666 patients were identified with a device subject to the advisory. In all, 1687 patients (63.2%) had RM at baseline. There were 487 deaths during follow-up. At a mean follow-up of 5.7 ± 0.7 years, mortality was higher in those without a remote monitor compared with RM at baseline (24.7% vs. 14.5%; P < 0.001). Pre-mature battery depletion was identified in 36 patients (2.1%) with RM vs. 7 (0.7%) without RM (P = 0.004). Time to battery replacement was significantly reduced in patients on RM (median 5 vs. 13 days, P = 0.001).

Conclusion: The use of RM in patients with ICD and cardiac resynchronization therapy under advisory improved detection of PBD, time to device replacement, and was associated with a reduction in all-cause mortality. The factors influencing the association with mortality are unknown and deserve further study.
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http://dx.doi.org/10.1093/europace/euab025DOI Listing
February 2021

Platelet Quiescence in Patients With Acute Coronary Syndrome Undergoing Coronary Artery Bypass Graft Surgery.

J Am Heart Assoc 2021 Feb 18;10(5):e016602. Epub 2021 Feb 18.

University of Ottawa Heart Institute Ottawa Ontario Canada.

Background The optimal antiplatelet strategy for patients with acute coronary syndromes who require coronary artery bypass surgery remains unclear. While a more potent antiplatelet regimen will predispose to perioperative bleeding, it is hypothesized that through "platelet quiescence," ischemic protection conferred by such therapy may provide a net clinical benefit. Methods and Results We compared patients undergoing coronary artery bypass surgery who were treated with a more potent antiplatelet inhibition strategy with those with a less potent inhibition through a meta-analysis. The primary outcome was all-cause mortality after bypass surgery. The analysis identified 4 studies in which the antiplatelet regimen was randomized and 6 studies that were nonrandomized. Combining all studies, there was an overall higher mortality with weaker strategies compared with more potent strategies (odds ratio, 1.38; 95% CI, 1.03-1.85; =0.03). Conclusions Our findings support the concept of platelet quiescence, in reducing mortality for patients with acute coronary syndrome requiring coronary artery bypass surgery. This suggests the routine up-front use of potent antiplatelet regimens in acute coronary syndrome, irrespective of likelihood of coronary artery bypass graft.
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http://dx.doi.org/10.1161/JAHA.120.016602DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8174246PMC
February 2021

Dietary Reference Intakes based on chronic disease endpoints: outcomes from a case study workshop for omega 3's EPA and DHA.

Appl Physiol Nutr Metab 2021 May 13;46(5):530-539. Epub 2021 Feb 13.

Department of Human Health & Nutritional Sciences, University of Guelph, Guelph, ON N1G 2W1, Canada.

Given the focus on developing Dietary Reference Intakes (DRIs) based on chronic disease risk reduction and recent research for omega-3 long chain PUFA since the last DRI review, the Canadian Nutrition Society convened a panel of stakeholders for a 1-day workshop in late 2019. Attendees discussed the new NASEM guidelines for establishing DRI values based on chronic disease risk endpoints and the strength of current evidence for EPA and DHA as it relates to the new guidelines. Summarizes evidence and expert opinions regarding the potential for reviewing DRI values for EPA and DHA and cardiovascular disease risk and early development.
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http://dx.doi.org/10.1139/apnm-2020-0994DOI Listing
May 2021

Prospective validation of Canadian TIA Score and comparison with ABCD2 and ABCD2i for subsequent stroke risk after transient ischaemic attack: multicentre prospective cohort study.

BMJ 2021 02 4;372:n49. Epub 2021 Feb 4.

Department of Emergency Medicine, Queen's University, Kingston, ON, Canada.

Objective: To validate the previously derived Canadian TIA Score to stratify subsequent stroke risk in a new cohort of emergency department patients with transient ischaemic attack.

Design: Prospective cohort study.

Setting: 13 Canadian emergency departments over five years.

Participants: 7607 consecutively enrolled adult patients attending the emergency department with transient ischaemic attack or minor stroke.

Main Outcome Measures: The primary outcome was subsequent stroke or carotid endarterectomy/carotid artery stenting within seven days. The secondary outcome was subsequent stroke within seven days (with or without carotid endarterectomy/carotid artery stenting). Telephone follow-up used the validated Questionnaire for Verifying Stroke Free Status at seven and 90 days. All outcomes were adjudicated by panels of three stroke experts, blinded to the index emergency department visit.

Results: Of the 7607 patients, 108 (1.4%) had a subsequent stroke within seven days, 83 (1.1%) had carotid endarterectomy/carotid artery stenting within seven days, and nine had both. The Canadian TIA Score stratified the risk of stroke, carotid endarterectomy/carotid artery stenting, or both within seven days as low (risk ≤0.5%; interval likelihood ratio 0.20, 95% confidence interval 0.09 to 0.44), medium (risk 2.3%; interval likelihood ratio 0.94, 0.85 to 1.04), and high (risk 5.9% interval likelihood ratio 2.56, 2.02 to 3.25) more accurately (area under the curve 0.70, 95% confidence interval 0.66 to 0.73) than did the ABCD2 (0.60, 0.55 to 0.64) or ABCD2i (0.64, 0.59 to 0.68). Results were similar for subsequent stroke regardless of carotid endarterectomy/carotid artery stenting within seven days.

Conclusion: The Canadian TIA Score stratifies patients' seven day risk for stroke, with or without carotid endarterectomy/carotid artery stenting, and is now ready for clinical use. Incorporating this validated risk estimate into management plans should improve early decision making at the index emergency visit regarding benefits of hospital admission, timing of investigations, and prioritisation of specialist referral.
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http://dx.doi.org/10.1136/bmj.n49DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7859838PMC
February 2021

Remote-only monitoring for patients with cardiac implantable electronic devices: a before-and-after pilot study.

CMAJ Open 2021 Jan-Mar;9(1):E53-E61. Epub 2021 Jan 25.

QEII Health Sciences Centre, Dalhousie University (Sapp, AbdelWahab, Parkash), Halifax, NS; Department of Cardiac Sciences (Gillis, Raj), University of Calgary, Calgary, Alta.; Institut universitaire de cardiologie and pneumologie de Quebec (Nault, Philippon), Université Laval, Québec, Que.; University of Ottawa Heart Institute (Nery, Wells), Ottawa, Ont.; Hamilton Health Sciences (Healey), McMaster University, Hamilton, Ont.; CK Hui Heart Centre (Lockwood), Edmonton, Alta.; Vancouver Island Health Authority (Sterns), Victoria, BC; East Carolina University (Sears), Greenville, NC; London Health Sciences Centre (Yee, Tang), University of Western Ontario, London, Ont.

Background: Outcomes for patients with cardiac implantable electronic devices are better when follow-up incorporates remote monitoring technology in addition to in-clinic visits. For patients with implantable devices, we sought to determine the feasibility, safety and associated health care utilization of remote-only follow-up, along with its effects on patients' quality of life and costs.

Methods: This multicentre before-and-after pilot study involved patients with new or existing pacemakers or implantable cardioverter defibrillators. The "before" phase of the study spanned the period October 2015 to February 2017; the "after" phase spanned the period October 2016 to February 2018. The exposure was remote-only follow-up in combination with Remote View, a service that facilitates access to device data, allowing device settings to be viewed remotely to facilitate remote programming. Outcomes at 12 months were feasibility (adherence to remote monitoring), safety (rate of adverse events) and health care utilization (remote and in-clinic appointments). We also assessed quality of life, using 3 validated scales, and costs, taking into account both health care system and patient costs.

Results: A total of 176 patients were enrolled. Adherence (defined as at least 1 successful remote transmission during follow-up) was 87% over a mean follow-up of 11.7 (standard deviation 2.2) months. There was a reduction in in-clinic visits at specialized sites among patients with both implantable defibrillators (26 v. 5, < 0.001, = 48) and pacemakers (42 v. 10, < 0.001, = 51). There was no significant change in visits to community sites for patients with defibrillators (13 v. 17, = 0.3, = 48). The composite rate of death, stroke, cardiovascular hospitalization and device-related hospitalization was 7% ( = 164). No adverse events were linked to the intervention. There was no change in quality-of-life scales between baseline and 12 months. Health care costs were reduced by 31% for patients with defibrillators and by 44% for those with pacemakers.

Interpretation: This pilot study showed the feasibility of remote-only follow-up, with no increase in adverse clinical outcomes and no effect on quality of life, but with reductions in costs and health care utilization. These results support progression to a larger-scale study of whether superior effectiveness and reduced cost can be achieved, with preservation of safety, through use of remote-only follow-up.

Trial Registration: ClinicalTrials.gov, no. NCT02585817.
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http://dx.doi.org/10.9778/cmajo.20200041DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7843075PMC
January 2021

A randomized ablation-based atrial fibrillation rhythm control versus rate control trial in patients with heart failure and high burden atrial fibrillation: The RAFT-AF trial rationale and design.

Am Heart J 2021 04 17;234:90-100. Epub 2021 Jan 17.

Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.

Heart failure (HF) and atrial fibrillation (AF) are 2 cardiac conditions that are increasing in prevalence and incidence. The 2 conditions frequently coexist, and are associated with increased morbidity and mortality. Catheter ablation of AF has been successfully performed in patients with HF, with an improvement in HF and AF, when compared to amiodarone, but further data is required to compare this to rate control. OBJECTIVES: The primary objective is to determine whether AF treated by catheter ablation, with or without antiarrhythmic drugs reduces all-cause mortality and hospitalizations for HF as compared with rate control in patients with HF and a high burden AF. METHODS: This is a multi-center prospective randomized open blinded endpoint (PROBE) study. Patients with NYHA class II-III HF (HF with reduced ejection fraction (<35%) or HF with preserved ejection fraction), and high burden AF are included in the trial. Patients are randomized to either rate control or catheter ablation-based AF rhythm control in a 1:1 ratio. Patients in the rate control group receive optimal HF therapy and rate control measures to achieve a resting hazard ratio (HR) < 80 bpm and 6-minute walk HR < 110 bpm. Patients randomized to catheter ablation-based AF rhythm control group receive optimal HF therapy and one or more aggressive catheter ablation, which include PV antral ablation and LA substrate ablation with or without adjunctive antiarrhythmic drug. The primary outcome is a composite of all-cause mortality and hospitalization for heart failure defined as an admission to a health care facility. The sample size is 600. Enrolment has been completed.
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http://dx.doi.org/10.1016/j.ahj.2021.01.012DOI Listing
April 2021

Canadian Registry of Electronic Device Outcomes (CREDO): The Abbott ICD Premature Battery Depletion Advisory, a Multicentre Cohort Study.

CJC Open 2021 Jan 12;3(1):48-53. Epub 2020 Sep 12.

Department of Medicine, Division of Cardiology, QEII Health Sciences Center, Halifax, Nova Scotia, Canada.

Background: Premature or rapid battery depletion may compromise the performance and reliability of an implantable cardioverter defibrillator (ICD), potentially resulting in harm or death to patients. We sought to describe the outcomes and clinical management of devices included in the Abbott ICD Premature Battery Depletion Advisory, using data from a Canadian registry.

Methods: This prospective observational study includes patients with an Abbott device subject to the advisory, from 9 centres in Canada. The incidence and outcomes related to device revision owing to premature battery depletion were identified and adjudicated by a committee.

Results: There were 2678 patients enrolled with a device subject to the advisory. Devices were implanted between 2010 and 2017; follow-up time was 5.7 ± 0.7 years. Device revision occurred in 222 patients (8.3%). Revision for premature battery depletion occurred in 43 patients (1.6%). Devices were revised at physician discretion on notice of the advisory in 16 patients (0.6%), and at patient request in 5 patients (0.2%). A total of 63 (2.4%) devices reached routine end of battery life. A further 95 (3.5%) patients underwent revision for other reasons. There were no reported major complications or adverse events with device revision owing to the advisory. There were no deaths attributed to premature battery depletion.

Conclusions: The rate of premature battery depletion associated with the Abbott ICD Premature Battery Depletion Advisory is low. There were no clinically adverse events identified that were associated with the battery performance of devices under advisory.
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http://dx.doi.org/10.1016/j.cjco.2020.09.008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7801196PMC
January 2021

Acute kidney injury after radial or femoral artery access in ST-segment elevation myocardial infarction: AKI-SAFARI.

Am Heart J 2021 04 7;234:12-22. Epub 2021 Jan 7.

CAPITAL Research Group, Division of Cardiology, Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada. Electronic address:

Background: Acute kidney injury (AKI) complicating primary percutaneous coronary intervention (PCI) is an independent predictor of short- and long-term outcomes in patients presenting with ST-elevation myocardial infarction (STEMI). Prior studies suggest a lower incidence of AKI in patients undergoing PCI through radial artery compared to femoral artery access; however, no randomized clinical trials have specifically investigated this question in patients presenting with STEMI.

Methods: To determine whether radial access (RA) is associated with a reduced frequency of AKI following primary PCI, we performed a substudy of the SAFARI-STEMI trial. The SAFARI-STEMI trial was an open-label, multicenter trial, which randomized patients presenting with STEMI to RA or femoral access (FA), between July 2011 and December 2018. The primary outcome of this post hoc analysis was the incidence of AKI, defined as an absolute (>0.5 mg/dL) or relative (>25%) increase in serum creatinine from baseline.

Results: In total 2,285 (99.3%) of the patients enrolled in SAFARI-STEMI were included in the analysis-1,132 RA and 1,153 FA. AKI occurred in 243 (21.5%) RA patients and 226 (19.6%) FA patients (RR: 0.91, 95% CI: 0.78-1.07, P = .27). An absolute increase in serum creatinine >0.5 mg/dL was seen in 49 (4.3%) radial and 52 (4.5%) femoral patients (RR: 1.04, 95% CI: 0.71-1.53, P = .83). AKI was lower in both groups when the KDIGO definition was applied (RA 11.9% vs FA 10.8%; RR: 0.90, 95% CI: 0.72-1.13, P = .38).

Conclusions: Among STEMI patients enrolled in the SAFARI-STEMI trial, there was no association between catheterization access site and AKI, irrespective of the definition applied. These results challenge the independent association between catheterization access site and AKI noted in prior investigations.
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http://dx.doi.org/10.1016/j.ahj.2020.12.019DOI Listing
April 2021

Post-operative pain following cardiac implantable electronic device implantation: insights from the BRUISE CONTROL trials.

Europace 2021 May;23(5):748-756

Division of Cardiology, Department of Medicine, University of Calgary, Libin Cardiovascular Institute, Calgary, AB, Canada.

Aims : Post-operative pain following cardiac implantable electronic device (CIED) insertion is associated with patient dissatisfaction, emotional distress, and emergency department visits. We sought to identify factors associated with post-operative pain and develop a prediction score for post-operative pain.

Methods And Results : All patients from the BRUISE CONTROL-1 and 2 trials were included in this analysis. A validated Visual Analogue Scale (VAS) was used to assess the severity of pain related to CIED implant procedures. Patients were asked to grade the most severe post-operative pain, average post-operative pain, and pain on the day of the first post-operative clinic. Multivariable regression analyses were performed to identify predictors of significant post-operative pain and to develop a pain-prediction score. A total of 1308 patients were included. Multivariable regression analysis found that the presence of post-operative clinically significant haematoma {CSH; P value < 0.001; odds ratio (OR) 3.82 [95% confidence interval (CI): 2.37-6.16]}, de novo CIED implantation [P value < 0.001; OR 1.90 (95% CI: 1.47-2.46)], female sex [P value < 0.001; OR 1.61 (95% CI: 1.22-2.12)], younger age [<65 years; P value < 0.001; OR 1.54 (95% CI: 1.14-2.10)], and lower body mass index [<20 kg/m2; P value < 0.05; OR 2.05 (95% CI: 0.98-4.28)] demonstrated strong and independent associations with increased post-operative pain. An 11-point post-operative pain prediction score was developed using the data.

Conclusion : Our study has identified multiple predictors of post-operative pain after CIED insertion. We have developed a prediction score for post-operative pain that can be used to identify individuals at risk of experiencing significant post-operative pain.
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http://dx.doi.org/10.1093/europace/euaa349DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8139821PMC
May 2021

Time to act-assessing variations in qPCR analyses in biological nitrogen removal with examples from partial nitritation/anammox systems.

Water Res 2021 Feb 4;190:116604. Epub 2020 Nov 4.

Department of Civil and Environmental Engineering Sciences, Institute IWAR, Chair of Wastewater Engineering, Technical University of Darmstadt, Franziska-Braun-Straße 7, 64287 Darmstadt, Germany.

Quantitative PCR (qPCR) is broadly used as the gold standard to quantify microbial community fractions in environmental microbiology and biotechnology. Benchmarking efforts to ensure the comparability of qPCR data for environmental bioprocesses are still scarce. Also, for partial nitritation/anammox (PN/A) systems systematic investigations are still missing, rendering meta-analysis of reported trends and generic insights potentially precarious. We report a baseline investigation of the variability of qPCR-based analyses for microbial communities applied to PN/A systems. Round-robin testing was performed for three PN/A biomass samples in six laboratories, using the respective in-house DNA extraction and qPCR protocols. The concentration of extracted DNA was significantly different between labs, ranged between 2.7 and 328 ng mg wet biomass. The variability among the qPCR abundance data of different labs was very high (1-7 log fold) but differed for different target microbial guilds. DNA extraction caused maximum variation (3-7 log fold), followed by the primers (1-3 log fold). These insights will guide environmental scientists and engineers as well as treatment plant operators in the interpretation of qPCR data.
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http://dx.doi.org/10.1016/j.watres.2020.116604DOI Listing
February 2021

GRADE Concept Paper 1: Validating the "F.A.C.E" instrument using stakeholder perceptions of feasibility, acceptability, cost, and equity in guideline implement.

J Clin Epidemiol 2021 Mar 1;131:133-140. Epub 2020 Dec 1.

Department of Family Medicine, University of Ottawa, Ottawa, Canada.

Background And Objective: To present a structured approach for assessing stakeholder perceptions and implementing the approach in guideline development.

Methods: This work was carried out by the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) Equity and Stakeholder Engagement Project Groups through brainstorming and iterative frameworks, stakeholder engagement, pilot testing, refinement of ideas, using input from workshops, and discussions at GRADE Working Group meetings to produce this document, which constitutes a GRADE conceptual article on implementation.

Results: We introduce the FACE implementation criteria, feasibility, acceptability, cost, and equity; priority; and "intent to implement" criterion. We outline the implementation importance of networks and approaches to patient and other stakeholder engagement. Implementation is often highly contextual and can benefit from stakeholder engagement and other assessments. Our FACE approach provides stakeholder questions and language to inform guideline implementation and tools.

Conclusion: The FACE criteria propose a series of knowledge translation questions to guide the assessment of implementation for evidence-based guidelines. It is desirable for guideline developers to use a conceptual approach, such as FACE, to tailor implementation and inform end of guideline dissemination and knowledge translation activities.
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http://dx.doi.org/10.1016/j.jclinepi.2020.11.018DOI Listing
March 2021

Aortic Stiffness, Central Blood Pressure, and Pulsatile Arterial Load Predict Future Thoracic Aortic Aneurysm Expansion.

Hypertension 2021 Jan 30;77(1):126-134. Epub 2020 Nov 30.

From the Division of Cardiology (K.E.B., L.B., K.C., T.C.), University of Ottawa Heart Institute, ON, Canada.

Thoracic aortic aneurysm is a disease associated with high morbidity and mortality. Clinically useful strategies for medical management of thoracic aortic aneurysm are critically needed. To address this need, we sought to determine the role of aortic stiffness and pulsatile arterial load on future aneurysm expansion. One hundred five consecutive, unoperated subjects with thoracic aortic aneurysm were recruited and prospectively followed. By combining arterial tonometry with echocardiography, we estimated measures of aortic stiffness, central blood pressure, steady, and pulsatile arterial load at baseline. Aneurysm size was measured at baseline and follow-up with imaging; growth was calculated in mm/y. Stepwise multivariable linear regression assessed associations of arterial stiffness and load measures with aneurysm growth after adjusting for potential confounders. Mean±SD age, baseline aneurysm size, and follow-up time were 62.6±11.4 years, 46.24±3.84 mm, and 2.92±1.01 years, respectively. Aneurysm growth rate was 0.43±0.37 mm/y. After correcting for multiple comparisons, higher central systolic (β±SE: 0.026±0.009, =0.007), and pulse pressures (β±SE: 0.032±0.009, =0.0002), carotid-femoral pulse wave velocity (β±SE: 0.032±0.011, =0.005), amplitudes of the forward (β±SE: 0.044±0.012, =0.0003) and reflected (β±SE: 0.060±0.020, =0.003) pressure waves, and lower total arterial compliance (β±SE: -0.086±0.032, =0.009) were independently associated with future aneurysm growth. Measures of aortic stiffness and pulsatile hemodynamics are independently associated with future thoracic aortic aneurysm growth and provide novel insights into disease activity. Our findings highlight the role of central hemodynamic assessment to tailor novel risk assessment and therapeutic strategies to patients with thoracic aortic aneurysm.
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http://dx.doi.org/10.1161/HYPERTENSIONAHA.120.16249DOI Listing
January 2021