Design and implementation of a population-based registry of implantable cardioverter defibrillators (ICDs) in Ontario

Lee, Douglas S.; Birnie, David H.; Cameron, Douglas; Crystal, Eugene; Dorian, Paul; Gula, Lorne J.; Healey, Jeffrey S.; Janmohammed, Amir; Khaykin, Yaariv; Krahn, Andrew D.; Lefeuvre, Catherine; Simpson, Christopher S.; Yee, Raymond; Hardy, Judy; Slaughter, Pamela M.; Chen, Zhongliang; Alter, David A.; Laupacis, Andreas; Tu, Jack V.

doi:10.1016/j.hrthm.2008.05.015

Cited by 38 publications

(26 citation statements)

References 17 publications

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“…and arrhythmogenic right ventricular cardiomyopathy (ARVC). 23 All patients provided written informed consent. The protocol was approved by the Health Sciences Research Ethics Board of the University of Western Ontario, as well as at each enrolling center.…”

Section: Clinical Perspective On P 285mentioning

confidence: 99%

Systematic Assessment of Patients With Unexplained Cardiac Arrest

et al. 2009

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Background-Cardiac arrest without evident cardiac disease may be caused by subclinical genetic conditions. Provocative testing to unmask a phenotype is often necessary to detect primary electrical disease, direct genetic testing, and perform family screening. Methods and Results-Patients with apparently unexplained cardiac arrest and no evident cardiac disease (normal cardiac function on echocardiogram, no evidence of coronary artery disease, and a normal ECG) underwent systematic evaluation that included cardiac magnetic resonance imaging, signal-averaged ECG, exercise testing, drug challenge, and selective electrophysiological testing. Diagnostic criteria were based on accepted criteria or provocation of the characteristic clinical features for long-QT syndrome, catecholaminergic polymorphic ventricular tachycardia, Brugada syndrome, early repolarization, arrhythmogenic right ventricular cardiomyopathy, coronary spasm, and myocarditis. Sixty-three patients in 9 centers were enrolled (age 43.0Ϯ13.4 years, 29 women Key Words: heart arrest Ⅲ diagnosis Ⅲ catecholamines Ⅲ genetics Ⅲ magnetic resonance imaging C ardiac arrest in the absence of evident structural heart disease is uncommon, with a broad differential diagnosis that includes subclinical cardiomyopathy, primary electrical disorders, and idiopathic ventricular fibrillation. [1][2][3][4][5] Growing recognition of the clinical features of uncommon genetic conditions that lead to cardiac arrest has reduced the number of cases that remain unexplained. Clinical Perspective on p 285Cardiac ion channel disorders that result in "primary electrical disease" may be difficult to diagnose unless overt ECG abnormalities are present. 6 -12 Subclinical QT prolongation, ST-segment shifts, or ventricular arrhythmias may be electrocardiographically subtle or intermittent. [13][14][15][16][17][18] Although an implantable cardioverter defibrillator (ICD) is indicated in patients who have had a cardiac arrest without a correctable cause, 19 optimal management to reduce recurrence requires a diagnosis. In addition, screening of family members is dependent on recognition of a phenotype that allows case finding, targeted genetic testing, and prophylactic intervention. We describe the yield of sequential noninvasive and invasive testing in Patients were enrolled between January 1, 2004, and October 1, 2008, in 8 adult and 1 pediatric electrophysiology center across Canada. During the recruitment period, the 9 involved centers enrolled 63 patients, during which time they implanted 1877 secondary-prevention ICDs (3.4%). On the basis of projections from the systematic data from a single year, an estimated 105 patients (5.6%) would have been excluded from enrollment because of cardiac arrest manifestly attributed to long-QT syndrome (LQTS), Brugada syndrome. and arrhythmogenic right ventricular cardiomyopathy (ARVC). 23 All patients provided written informed consent. The protocol was approved by the Health Sciences Research Ethics Board of the University of Western Ontario, as well...

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Section: Clinical Perspective On P 285mentioning

confidence: 99%

Systematic Assessment of Patients With Unexplained Cardiac Arrest

et al. 2009

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“…14 Finally, the present findings are consistent with the perioperative complication rate of 3.7% observed in the Ontario ICD Database. 24 This database is comparable to the US National Cardiovascular Data Registry ICD Registry in that it is a prospective registry of patients undergoing ICD implantation with mandated participation by the Ministry of Health and Long-Term Care in Ontario. Trained data collectors enter data into the Ontario ICD Database, and quality controls include random site audits with reabstraction of randomly selected charts by central study personnel.…”

Section: Discussionmentioning

confidence: 99%

Gender Differences in Procedure-Related Adverse Events in Patients Receiving Implantable Cardioverter-Defibrillator Therapy

et al. 2009

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were male, and 27% were female. Women were more likely to have a history of heart failure (81% versus 77%, PϽ0.01), worse New York Heart Association functional status (57% versus 50% in class III and IV, PϽ0.01), and nonischemic cardiomyopathy (44% versus 27%, PϽ0.01) and were more likely to receive biventricular ICDs (39% versus 34%, PϽ0.01). In unadjusted analyses, women were more likely to experience any adverse event (4.4% versus 3.3%, PϽ0.001) and major adverse events (2.0% versus 1.1%, PϽ0.001). In multivariable models, women had a significantly higher risk of any adverse event (OR 1.32, 95% CI 1.24 to 1.39) and major adverse events (OR 1.71, 95% CI 1.57 to 1.86). Conclusions-Women are more likely than men to have in-hospital adverse events related to ICD implantation. Efforts are needed to understand the reasons for higher ICD implantation-related adverse event rates in women and to develop strategies to reduce the risk of these events.

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“…7 The Ontario ICD Database prospectively collected information on patient characteristics, device indication, and implant-related data from all 10 adult defibrillator implantation centers in the province. Data were collected by cardiac electrophysiologists and trained research coordinators at ICD implantation centers, who entered real-time data into a secure, firewall-and password-protected Web-based registry.…”

Section: Methods the Ontario Icd Databasementioning

confidence: 99%

“…Clinical and device-related events occurring during follow-up were captured during defibrillator clinic visits at either the implanting hospital or peripheral device clinics. 7 The Ontario ICD Database used continuous data quality assessments via automated logic and range checks including dates of all events, notification of uncoded data elements, and random site audits performed in 5% of patients, ensuring κ statistic or crude agreement rates ≥0.7.…”

Section: Methods the Ontario Icd Databasementioning

confidence: 99%

Survival After Implantable Cardioverter-Defibrillator Implantation in the Elderly

Yung

Birnie²,

Dorian³

et al. 2013

Circulation

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I mplantable cardioverter-defibrillators (ICDs) used in appropriately selected patients at high risk of sudden cardiac death are associated with reduction in arrhythmic death. 1 Recommendations for ICDs are based on large randomized, controlled trials, which often enroll highly selected patients who are often young with few comorbidities. In contrast, the average patient with heart failure and severe left ventricular systolic dysfunction is aged >65 years with multiple comorbidities. With the aging population, the number of elderly patients being considered for ICD implantation is increasing, and an estimated 28% of those deemed potentially eligible by conventional criteria are octogenarians.2 However, with advancing age and comorbidity burden, the relative contribution of nonarrhythmic causes of death may increase, 3,4 potentially attenuating the benefits of ICD therapy. Current guidelines do not specifically address the appropriateness or prognosis of ICD implantation with advanced age. 1,5,6 Clinical Perspective on p 2392Randomized trials can underrepresent elderly patients, while population-based registries may illuminate the impact and outcomes of ICDs implanted in this group. The Ontario ICD Database is a large, population-based, prospective registry of ICD recipients referred for primary or secondary prevention defibrillator implantation. Using this registry, we examined all-cause mortality, appropriate and inappropriate defibrillator shocks, hospitalization, and early complications in elderly ICD Background-The benefit of implantable cardioverter-defibrillators (ICDs) among elderly patients is controversial and may be attenuated by nonarrhythmic death. We examined the impact of age on device-delivered therapies and outcomes after primary or secondary prevention ICD. Methods and Results-In a prospective, inclusive registry of 5399 ICD recipients in Ontario, Canada (February 2007 to September 2010), device-delivered therapies and complications were determined at routine clinic visits. Among primary prevention ICD recipients aged 18 to 49 (n=317), 50 to 59 (n=769), 60 to 69 (n=1336), 70 to 79 (n=1242), and ≥80 (n=275) years, mortality increased with age, as follows: 2.1, 3.0, 5.4, 6.9, and 10.2 deaths per 100 person-years, respectively (P<0.001). Secondary prevention ICD recipients aged 18 to 49 (n=114), 50 to 59 (n=244), 60 to 69 (n=481), 70 to 79 (n=462), and ≥80 (n=159) years also exhibited increasing mortality, as follows: 2.2, 3.8, 6.1, 8.7, and 15.5 deaths per 100 person-years, respectively (P<0.001). However, rates of appropriate shock were similar across age groups: from 6.7 (18-49 years) to 4.2 (≥80 years) per 100 person-years after primary prevention ICDs (P=0.139) and from 11.4 (18-49 years) to 11.9 (≥80 years) per 100 person-years after secondary prevention ICDs (P=0.993). Covariate-adjusted competing risk analysis demonstrated higher risk of death (P trend <0.001 for both primary and secondary prevention) but no significant decline in appropriate shocks with older age after primary (P=0.130) ...

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Design and implementation of a population-based registry of implantable cardioverter defibrillators (ICDs) in Ontario

Cited by 38 publications

References 17 publications

Systematic Assessment of Patients With Unexplained Cardiac Arrest

Systematic Assessment of Patients With Unexplained Cardiac Arrest

Gender Differences in Procedure-Related Adverse Events in Patients Receiving Implantable Cardioverter-Defibrillator Therapy

Survival After Implantable Cardioverter-Defibrillator Implantation in the Elderly

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