Canadian Implantable Defibrillator Study (CIDS): Study design and organization

doi:10.1016/0002-9149(93)90972-F

The American Journal of Cardiology

Volume 72, Issue 16, 26 November 1993, Pages F103-F108

https://doi.org/10.1016/0002-9149(93)90972-F Get rights and content

Abstract

The Canadian Implantable Defibrillator Study (CIDS) is an on-going randomized multicenter clinical trial that compares implantable cardioverter-defibrillator (ICD) therapy against amiodarone in patients with prior cardiac arrest or hemodynamically unstable ventricular tachycardia. Eligible patients are equally randomized to receive or not receive an ICD as initial management. Those not receiving an ICD receive amiodarone. All patients are seen in follow-up every 6 months. The primary outcome event cluster is arrhythmic death or any other death occurring within 30 days of therapy initiation. Secondary outcomes are all-cause mortality and nonfatal occurrences of ventricular tachycardia or fibrillation. The goal of the study is to recruit 400 patients over 4 years. All patients will be followed to the end of the year. This will result in an 80% chance of detecting a reduction in arrhythmic death of 58% by ICD if such a difference in truth exists. Recruitment began in October 1990 and 184 patients have been enrolled to date.

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Effect of early changes in functional geometry of left ventricular contraction on the development of ventricular fibrillation during acute myocardial ischaemia. An experimental study
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Citation Excerpt :
Early ventricular arrhythmias during the first 30 min of myocardial ischaemia occur in a biphasic temporal distribution – that is, phase 1a (“immediate”) and phase 1b (“delayed”). The early (during the first 30 min after acute coronary occlusion) incidence of primary VF complicating acute MI has been extensively documented in previous studies.1–9 These studies consistently showed a causal association between VF and the post-infarction LV cavity dilatation, cell-to-cell interaction,6 and elevation of plasma levels of adrenergic neurohormones.8
The early appearance of ventricular fibrillation (VF) following acute myocardial infarction (MI) is associated with adrenergic effects and electrical interactions although some early “mechanical” changes may also occur. The aim of the present experimental study was to examine whether early changes in the functional geometry of left ventricular (LV) contraction may be associated with ventricular arrhythmias occurring during the first 120 min of MI.
In 11 swine left anterior descending (LAD) coronary artery ligation was performed. Aortic flow, LV end-diastolic pressure (LVEDP), LV long and short axis lengths were measured and their fractional shortening (FS) was calculated before and during the initial 120 min period of MI.
LV long axis FS and aortic flow decreased (p < 0.001) whereas LVEDP increased (p < 0.01) in all 11 animals within 30 min following LAD ligation. LV long and short axis lengths and LV short axis FS did not change significantly. VF occurred in 5 of the 11 animals within this 30 min period. LV short axis FS decreased (p < 0.05) in all 5 animals prior to VF and increased (p < 0.05) in all 6 animals without VF. In 3 of the 6 animals that had no VF during the initial 30 min VF occurred later. Similarly, LV short axis FS decreased prior to VF in all those 3 animals. LV short axis FS did not decrease in any of the remaining 3 swine without VF during the same period of time.
Early changes in the functional geometry of LV contraction, in the form of a reduction of LV short axis FS, are associated with a greater incidence of VF in experimental acute MI.
Effect of risk stratification on cost-effectiveness of the implantable cardioverter defibrillator
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Background Implantable cardioverter defibrillators (ICDs) effectively prevent sudden cardiac death, but selection of appropriate patients for implantation is complex. We evaluated whether risk stratification based on risk of sudden cardiac death alone was sufficient to predict the effectiveness and cost-effectiveness of the ICD. Methods We developed a Markov model to evaluate the cost-effectiveness of ICD implantation compared with empiric amiodarone treatment. The model incorporated mortality rates from sudden and nonsudden cardiac death, noncardiac death and costs for each treatment strategy. We based our model inputs on data from randomized clinical trials, registries, and meta-analyses. We assumed that the ICD reduced total mortality rates by 25%, relative to use of amiodarone. Results The relationship between cost-effectiveness of the ICD and the total annual cardiac mortality rate is U-shaped; cost-effectiveness becomes unfavorable at both low and high total cardiac mortality rates. If the annual total cardiac mortality rate is 12%, the cost-effectiveness of the ICD varies from $36,000 per quality-adjusted life-year (QALY) gained when the ratio of sudden cardiac death to nonsudden cardiac death is 4 to $116,000 per QALY gained when the ratio is 0.25. Conclusions The cost-effectiveness of ICD use relative to amiodarone depends on total cardiac mortality rates as well as the ratio of sudden to nonsudden cardiac death. Studies of candidate diagnostic tests for risk stratification should distinguish patients who die suddenly from those who die nonsuddenly, not just patients who die suddenly from those who live. (Am Heart J 2002;144:440-8.)
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Canadian Implantable Defibrillator Study (CIDS): Study design and organization

Abstract

J Am Coll Cardiol

J Am Coll Cardiol

Am J Cardiol

J Am Coll Cardiol

J Am Coll Cardiol

J Am Coll Cardiol

Am Heart J