(Circulation. 2000;101:1297.)
© 2000 American Heart Association, Inc.
Clinical Investigation and Reports |
Canadian Implantable Defibrillator Study (CIDS)
A Randomized Trial of the Implantable Cardioverter Defibrillator Against Amiodarone
From the Departments of Medicine (S.J.C.) and Clinical Epidemiology and Biostatistics (M.G., R.S.R., B.O.), McMaster University, Hamilton, Ontario, and the Departments of Medicine at the University of Toronto (P.D.), University of Montreal (D.R.), University of Calgary (R.S.S., L.B.M.), University of Ottawa (M.S.G.), and the University of Western Ontario (G.J.K.), Canada.
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Abstract |
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Background—Patients surviving ventricular fibrillation (VF) or sustained ventricular tachycardia (VT) are at a high risk of death due to a recurrence of arrhythmia. The implantable cardioverter defibrillator (ICD) terminates VT or VF, but it is not known whether this device prolongs life in these patients compared with medical therapy with amiodarone.
Methods and Results—A total of 659 patients with resuscitated VF or VT or with unmonitored syncope were randomly assigned to treatment with the ICD or with amiodarone. The primary outcome measure was all-cause mortality, and the secondary outcome was arrhythmic death. A total of 328 patients were randomized to receive an ICD. A thoracotomy was done in 33, no ICD was implanted in 18, and the rest had a nonthoracotomy ICD. All 331 patients randomized to amiodarone received it initially. At 5 years, 85.4% of patients assigned to amiodarone were still receiving it at a mean dose of 255 mg/day, 28.1% of ICD patients were also receiving amiodarone, and 21.4% of amiodarone patients had received an ICD. A nonsignificant reduction in the risk of death was observed with the ICD, from 10.2% per year to 8.3% per year (19.7% relative risk reduction; 95% confidence interval, -7.7% to 40%; P=0.142). A nonsignificant reduction in the risk of arrhythmic death was observed, from 4.5% per year to 3.0% per year (32.8% relative risk reduction; 95% confidence interval, -7.2% to 57.8%; P=0.094).
Conclusions—A 20% relative risk reduction occurred in all-cause mortality and a 33% reduction occurred in arrhythmic mortality with ICD therapy compared with amiodarone; this reduction did not reach statistical significance.
Key Words: heart arrest • tachycardia • amiodarone • defibrillators, implantable
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Introduction |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix 1References |
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The implantable cardioverter defibrillator (ICD) detects and rapidly terminates ventricular fibrillation (VF) and ventricular tachycardia (VT). Antiarrhythmic drug therapy has been the primary treatment for patients with a history of resuscitated VF and/or sustained VT who are at a high risk of death. However, large randomized trials have raised major concerns about the lack of efficacy and the proarrhythmic potential of Vaughan Williams Class I drugs1 and at least one Class III drug.2 Amiodarone, however, is still considered an effective antiarrhythmic agent that is largely free of proarrhythmic effects. Recently, a meta-analysis of randomized, controlled trials of amiodarone confirmed that this drug reduces arrhythmic death and has a modest beneficial effect on overall mortality in high-risk patients.3 Recently, the Antiarrhythmic versus Implantable Defibrillator (AVID) study reported a reduction in mortality with the ICD compared with antiarrhythmic drug therapy in patients with VF or VT.4 The purpose of the present study was to compare the efficacy of the ICD and amiodarone for the prevention of death in patients with previous sustained ventricular arrhythmia.
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Methods |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix 1References |
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Inclusion Criteria
Patients were eligible for this study if, in the absence of either recent acute myocardial infarction (
72 hours) or electrolyte
imbalance, they manifested any of the following: (1) documented VF; (2)
out-of-hospital cardiac arrest requiring defibrillation or
cardioversion; (3) documented, sustained VT causing syncope; (4) other
documented, sustained VT at a rate 
150 beats/min, causing presyncope
or angina in a patient with a left ventricular ejection
fraction 35%; or (5) unmonitored syncope with subsequent
documentation of either spontaneous VT10 s or sustained (30 s)
monomorphic VT induced by programmed ventricular
stimulation. Patients could meet inclusion criteria 3 or 4 on the basis
of a ventricular tachyarrhythmia induced in
the electrophysiology laboratory if both of the following conditions
were met: (1) they had prior, spontaneous, documented, sustained VT and
(2) the induced arrhythmia in the electrophysiology laboratory
was monomorphic, sustained VT.
Exclusion Criteria
Patients were excluded for any of the following reasons: (1) ICD
or amiodarone not considered appropriate as a treatment for the
tachyarrhythmia, (2) excessive
perioperative risk for ICD implantation; (3) previous
amiodarone therapy for 6 weeks; (4) nonarrhythmic medical
condition making 1-year survival unlikely, and (5) long-QT syndrome.
Eligible patients giving informed consent were entered into the study.
The study protocol was reviewed and approved by the Institutional
Review Board/Ethics Committee at each of the participating clinical
centers.
Randomization
Central randomization was stratified by clinical center and by
left ventricular ejection fraction (35% and
>35%).
ICD
Patients randomized to receive the ICD were scheduled for
surgery at the earliest possible date. Implant criteria were met with 3
consecutive successful defibrillations at 10 J below maximum device
output. Either thoracotomy or nonthoracotomy lead systems were
used.
Amiodarone
Patients randomized to amiodarone received it in the
following manner: 1200 mg/day for 1 week in the hospital, 400
mg/day for 10 weeks, and then 300 mg/day. In patients who developed
intolerable side effects, the dose of amiodarone could be
lowered to a minimum of 200 mg/day. All patients were seen for
follow-up at 2 months and 6 months after randomization and every 6
months thereafter.
Cointervention
Antiarrhythmic drugs could be used for patients in either
treatment group to control supraventricular or nonsustained
ventricular tachycardias that were
symptomatic or that might cause discharge of the
ICD.
Outcome Events
The primary outcome event was death from any cause. The
secondary outcome event was arrhythmic death; this was based on the
clinical classification of cardiac deaths developed by Hinkle and
Thaler.5 All deaths were adjudicated by an External
Validation Committee whose members had no other affiliation to the
study. Despite best efforts, it was not always possible to blind the
External Validation Committee to treatment allocation. Results of ICD
interrogation after death were not used to determine cause-specific
mortality because this information was only available in ICD
patients.
Statistical Methods
The cumulative mortality experience of each treatment group was
summarized as a survival curve, which was estimated using the
Kaplan-Meier method.6 The survival curves were compared
using a Mantel-Haenszel test incorporating stratification for left
ventricular ejection fraction.7 Cox’s
proportional hazards method was used to adjust for imbalances in
baseline prognostic risk and to investigate potential subgroup
effects.8
The study was originally designed with a primary outcome of arrhythmic
death; however, in 1993, the Steering Committee decided to change the
primary outcome measure to all-cause mortality because of concerns that
the ICD might prevent some arrhythmic deaths but, due to competing
risks, have little effect on overall survival. This change led to an
increase in the patient enrollment target from 400 to 650 patients,
which provided 90% power to detect a relative reduction in all-cause
mortality of 33% by the ICD from an anticipated 3-year mortality rate
of 30% on amiodarone. Crossover rates of 5% per year for both
treatment groups were anticipated. The primary analysis was
originally conceived of as a one-sided comparison with a clear
directional hypothesis that the ICD would be superior to
amiodarone. When the study was initiated, amiodarone
was standard therapy, and we had no interest in proving that ICD
treatment was worse than amiodarone. In response to the review
process, 2-sided statistics are presented. Analysis was
based on the intention-to-treat principle. An External Safety and
Efficacy Monitoring Committee reviewed the unblinded study data every 6
months for safety and did 3 formal interim analyses of efficacy
on the basis of an intention to stop the study early in favor of ICD if
1-sided P0.001.
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Results |
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Patient Enrollment
Patient enrollment occurred between October 1990 and January 1997. The mean duration of follow-up was 2.9 and 3.0 years for amiodarone and ICD patients, respectively. The baseline demographic and clinical characteristics of the 2 treatment groups, as shown in Table 1
, were well balanced.
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Therapy
Among the 328 patients randomly allocated to receive an ICD,
310 (94.5%) received one. The median time to ICD implantation was 7
days, and 91.3% of patients received the ICD within 21 days of
randomization. A thoracotomy was performed in 33 patients; this
procedure had a 30-day mortality rate of 3.3% (1 patient). A
nonthoracotomy lead system was implanted in the rest of the patients;
the 30-day mortality rate for this procedure was 0.36% (1 patient). Of
the 18 patients who did not receive an ICD, 7 died in the hospital
while awaiting ICD surgery; in 10 patients, either the patient or his
or her physician decided against an ICD after randomization; and a
technical problem occurred in 1 patient. A total of 16 patients had
their ICD permanently or temporarily explanted because of infection,
heart transplantation, or patient preference. The total number of
patient-years at risk while patients did not have an ICD in place due
to cancelled or delayed implantation or ICD explantation was 72.5
years; this represents 7.3% of total patient-years at risk for
the ICD patients. The percentage of patients randomized to an ICD who
were also receiving amiodarone at 1, 3, and 5 years after
randomization were 17.4%, 21.7%, and 28.1%, respectively. The mean
amiodarone dose in these patients at 3 years was 277 mg/day.
The cumulative risk of receiving an ICD shock was 65.4% at 4
years.
The proportion of patients assigned to amiodarone who were receiving it at 2 months and 1, 3, and 5 years was 96.2%, 88.7%, 80.3%, and 85.4%, respectively, with mean doses of 390, 306, 262, and 255 mg/day, respectively. Of the 331 patients allocated to amiodarone, 52 received an ICD. The cumulative proportion of amiodarone patients receiving an ICD at 1, 3, and 5 years was 9.0%, 18.6%, and 21.4%. The median time from randomization to ICD implantation was 334 days for these patients. Patients allocated to amiodarone were also treated with an ICD for a total of 111 patient-years, which was 11.6% of the total patient-years at risk for this treatment group.
Concomitant Medications
Table 2 summarizes the use of
antiarrhythmic medications other than amiodarone during
follow-up. An imbalance existed between the use of each of the 4 types
of antiarrhythmic drugs: significantly more drugs were used in patients
randomized to ICD treatment. This imbalance was most marked for
sotalol, which was taken by many more ICD patients than
amiodarone patients. The imbalance in the use of either sotalol
or another ß-blocker was large: 22.9% for the amiodarone
group and 53.3% for the ICD group.
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Fatal Outcomes
Table 3 summarizes the fatal
outcomes of patients in the study. A nonsignificant reduction in
all-cause mortality occurred with the ICD compared with amiodarone,
from 10.2% per year to 8.3% per year (19.7% relative risk
reduction [RRR]; 95% confidence interval [CI], -7.7% to 40.0%;
P=0.142). There was also a nonsignificant reduction in
arrhythmic death with the ICD, from 4.5% per year to 3.0% per year
(32.8% RRR; 95% CI, -7.2% to 57.8%; P=0.094). Only
minor differences existed in the rates of other cardiac death,
noncardiac vascular death, and nonvascular death. Total cardiac death
was reduced from 8.6% per year to 6.7% per year (23.4% RRR; 95% CI,
-5.7% to 44.5%; P=0.104). Figure 1 shows the Kaplan-Meier plots of the
cumulative risk of death over 4 years for the ICD and
amiodarone treatment groups. Table 4 shows the mortality rates at 1, 2, and
3 years for each treatment group, as well as the relative and absolute
risk reductions. The RRR for total mortality was 15.4% at 1 year,
29.7% at 2 years, and 13.7% at 3 years.
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Subgroups
Figure 2 illustrates the
hazard ratios and the 95% CIs for all-cause mortality in different
subgroups of patients. None of the tests of interaction between the
various baseline patient characteristics and treatment was significant.
Thus, no identifiable subgroup benefited significantly more or less
from the ICD.
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Adverse Experiences
Adverse experiences potentially related to ICD or
amiodarone therapy are shown in Table 5. The risk of pulmonary
infiltrate in amiodarone patients was 1.9% per year. In ICD
patients, device malfunction was rare, and pocket infection occurred at
a rate of 1.4% per year.
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Discussion |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix 1References |
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This randomized trial compared ICD therapy with amiodarone therapy in patients who had VF, sustained VT, or unmonitored syncope likely due to VT. The study was designed to detect reliably a relative reduction in risk of death of 33% from an expected 3-year mortality rate of 30% on amiodarone. The observed mortality rate in the amiodarone group was, as anticipated, almost 30%, but the observed RRR in all-cause mortality resulting from the use of the ICD was only 19.7%, which is not conventionally significant. However, the analysis of cause-specific mortality in this study supports the presumed mechanism of action of ICD therapy, which is to prevent deaths caused by ventricular arrhythmia. Fifteen fewer deaths occurred in patients randomized to the ICD than in those randomized to amiodarone; this difference was accounted for by 13 fewer arrhythmic deaths and by 2 fewer nonarrhythmic deaths. Thus, almost all of the observed benefit in mortality risk was due to a reduction in arrhythmic death, as would be expected from an antiarrhythmic intervention. This increases confidence that the observed mortality reduction may not be due to chance but to a real benefit of the ICD.
The observed risk reduction in this trial (CIDS) is smaller than that observed in the AVID trial, which had a very similar design.4 The patients and treatments studied in AVID were almost identical to those in CIDS. Although the design of AVID included the possibility of patients in the medical arm receiving sotalol, virtually all of the medically treated patients actually received amiodarone. At 3 years, mortality was reduced by the ICD by 31% (95 CI, -10% to 52%) in the AVID trial and by 20% (95% CI, -8% to 40%) in CIDS. Although the observed RRR associated with the ICD is less in CIDS than in the AVID study, the 95% CIs of the 2 estimates overlap substantially, indicating that the 2 results are not inconsistent with each other. The proportion of medically treated patients actually receiving amiodarone was similar between the studies, as was the mean amiodarone dose. A higher proportion of patients received concomitant ß-blocker or sotalol therapy in the amiodarone group in CIDS (23.7%) than in AVID (16.8%) at 1 year. This could have enhanced the effectiveness of amiodarone in CIDS, because a positive interaction between amiodarone and ß-blockers has been reported.9 10
At 3 years, the rate of concomitant use of amiodarone in ICD
patients was 33.7% in AVID and 21.7% in CIDS, and the use of the ICD
in amiodarone patients was 24.3% in AVID and 18.6% in CIDS.
These higher rates of treatment crossover in AVID would be expected to
reduce the observed treatment effect rather than to increase it. The
AVID trial was stopped early due to a greater than expected benefit of
the ICD over medical therapy. Trials stopped early for this reason have
a general tendency to overestimate the benefit of treatment; this may
explain, in part, the greater RRR observed in AVID. As shown in Table 4
, the RRR in CIDS decreased to 13.7% at year 3. It is possible
that the smaller ICD benefit observed in CIDS is due to its longer
duration of follow-up compared with the AVID study.
The statistical power of a clinical trial is more directly dependent on the total number of events than on the number of patients. The AVID study enrolled more patients than CIDS, but it followed them for a shorter amount of time; thus, the total number of fatal events in the 2 studies was similar (202 for AVID, 181 for CIDS). We conclude that the overall similarity in design and execution of CIDS and AVID and the overlapping CIs indicate that the difference in observed risk reduction is most likely due to chance. It is probable that the true benefit of the ICD over amiodarone lies between the estimates of AVID and CIDS.
The significantly higher use of ß-blockers and digoxin among ICD patients compared with amiodarone patients in this study was anticipated because it is common to use these drugs in patients with an ICD. ß-blockers are an effective treatment in patients after a myocardial infarction; they produce a 20% reduction in total death and a 30% reduction in arrhythmic death.11 Furthermore, evidence exists that the effectiveness of amiodarone may be potentiated by ß-blockers.9 10 It is, therefore, possible that the imbalance in ß-blocker therapy accounts for some of the observed treatment benefit of the ICD in both CIDS and AVID. The degree to which this occurred is uncertain because the cointervention was not random, and there are no valid means of correcting for it.
In summary, CIDS observed a relative reduction in all-cause mortality of 19.7% with the ICD compared with amiodarone (which is not statistically significant), with a 33% relative reduction in arrhythmic death. In light of the results of the AVID study, CIDS provides further support for the superiority of the ICD over amiodarone in the treatment of patients with symptomatic sustained VT or resuscitated cardiac arrest.
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Acknowledgments |
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Supported by the Medical Research Council of Canada. The amiodarone was supplied by Wyeth-Ayerst Pharmaceuticals, Ltd.
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Footnotes |
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Reprint requests to Stuart J. Connolly, MD, FRCPC, Faculty of Health Sciences, McMaster University, 237 Barton St East, Hamilton, Ontario, Canada L8L 2X2.
A complete list of study participants can be found in the Appendix.
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Appendix 1 |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix 1References |
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CIDS Participants
The number of patients enrolled by each center is given in parentheses.
Canada
St. Michael’s Hospital, Toronto, Ontario (123): P.
Dorian, D. Newman, J. Mitchell, and M. Greene; Hamilton Health Sciences
Corporation, Hamilton, Ontario (98): S. Connolly, C. LeFeuvre, J.
Kwasney, and S. Morino; Institute de Cardiologie de Montreal,
Montréal, Quebec (96): D. Roy, M. Dubuc, M. Talajic, and B.
Thibault; Calgary General Hospital, Calgary, Alberta (79): R.
Sheldon and M. Koshman; Ottawa Civic Hospital, Ottawa, Ontario
(44): M. Green, A. Tang, and M. Luce; Foothills Hospital, Calgary,
Alberta (41): B. Mitchell, D. Wyse, H.J. Duff, A. Gillis, and P.
Cassidy; University Hospital, London, Ontario (31): G. Klein, R.
Yee, and C. Norris; Royal Victoria Hospital, Montreal, Quebec
(21): M. Sami and D. Liebling; Toronto General Hospital,
Toronto, Ontario (21): D. Cameron, E. Downar, L. Harris,
M. Waxman, and B. Weller; Hopital du Sacre-Coeur, Montreal, Quebec
(17): T. Kus, F. Molin, P. Pagé, and G. Gaudette; Queen
Elizabeth, Health Sciences Center, Halifax, Nova Scotia (15): M.J.
Gardner, L. Sterns, and G. Blackmore; University of Alberta Hospital,
Edmonton, Alberta (10): S. Gulamhusein, K. Kavanagh, S. Kimber, K.
Paradon, and R. Tabler; Currans Health Center, Thunder Bay,
Ontario (10): C. Lai and K. Kwiatkowski; Montreal General
Hospital, Montreal, Quebec (9): M. Rosengarten; Quebec Heart
Institute, Saint-Foy, Quebec (7): G. O’Hara, M. Gilbert, F.
Philippon, and L. Charbonneau; Royal University Hospital, Saskatoon,
Saskatchewan (4): B. Cujec and S. Summach; University Hospital,
Vancouver, British Columbia (3): J. Yeung, C. Kerr, C. McIlroy,
and M. Hawes; St. Paul’s Hospital, Vancouver, British Columbia
(2): J. Boone and S. Flavelle; Victoria Clinic, Victoria, British
Columbia (1): J. Bonet and K. Ilott.
Australia
John Hunter Hospital, New Lambton Heights, New South Wales
(10): J.W. Leitch, J. Silberberg, E. Nyman, and K. Cox; Royal Perth
Hospital, Perth (2): M. Davis and C. May; St. Vincent’s Hospital,
Darlinghurst, New South Wales (1): D. Kuchar and A. Cook.
United States
Veterans Affairs Medical Center-West Los Angeles, Los Angeles,
Calif (7): P. Sager, B. Singh, R. Connolly, and M. Cui; Veterans
Affairs Medical Center, Albuquerque, NM (7): R. Cataldo and L.
Beeman.
Administration
Steering Committee
S. Connolly, M. Gent, R. Roberts, P. Dorian, D. Roy, R. Sheldon,
L.B. Mitchell, M. Green, G. Klein, and B. O’Brien.
Coordinating and Methods Center
M. Gent, R. Roberts, and E. Themeles, Hamilton, Ontario.
External Validation Committee
M. Gent (Chair), J. Blakely, and C. Morgan, Toronto,
Ontario.
External Safety and Efficacy and Monitoring Committee
M. Bourassa, Montreal, Quebec; and G. Wisenberg, London,
Ontario,
Received May 5, 1999; revision received September 25, 1999; accepted October 8, 1999.
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References |
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D. R. Tomlinson, Y. Bashir, T. R. Betts, and K. Rajappan Accuracy of manual QRS duration assessment: its importance in patient selection for cardiac resynchronization and implantable cardioverter defibrillator therapy Europace, May 1, 2009; 11(5): 638 - 642. [Abstract] [Full Text] [PDF]
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M. M. Gulizia, L. Piraino, M. Scherillo, C. Puntrello, C. Vasco, M. C. Scianaro, F. Mascia, O. Pensabene, S. Giglia, G. Chiaranda, et al. A Randomized Study to Compare Ramp Versus Burst Antitachycardia Pacing Therapies to Treat Fast Ventricular Tachyarrhythmias in Patients With Implantable Cardioverter Defibrillators: The PITAGORA ICD Trial Circ Arrhythm Electrophysiol, April 1, 2009; 2(2): 146 - 153. [Abstract] [Full Text] [PDF]
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A. Proclemer, M. Ghidina, D. Gregori, D. Facchin, L. Rebellato, P. Fioretti, and M. Brignole Impact of the main implantable cardioverter-defibrillator trials in clinical practice: data from the Italian ICD Registry for the years 2005-07 Europace, April 1, 2009; 11(4): 465 - 475. [Abstract] [Full Text] [PDF]
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C. A. Muratore, L. A. Batista Sa, P. A. Chiale, R. Eloy, M. C. Tentori, J. Escudero, A. M. C. Lima, L. E. Medina, R. Garillo, and J. Maloney Implantable cardioverter defibrillators and Chagas' disease: results of the ICD Registry Latin America Europace, February 1, 2009; 11(2): 164 - 168. [Abstract] [Full Text] [PDF]
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R. W. Neumar, J. P. Nolan, C. Adrie, M. Aibiki, R. A. Berg, B. W. Bottiger, C. Callaway, R. S.B. Clark, R. G. Geocadin, E. C. Jauch, et al. Post-Cardiac Arrest Syndrome: Epidemiology, Pathophysiology, Treatment, and Prognostication A Consensus Statement From the International Liaison Committee on Resuscitation (American Heart Association, Australian and New Zealand Council on Resuscitation, European Resuscitation Council, Heart and Stroke Foundation of Canada, InterAmerican Heart Foundation, Resuscitation Council of Asia, and the Resuscitation Council of Southern Africa); the American Heart Association Emergency Cardiovascular Care Committee; the Council on Cardiovascular Surgery and Anesthesia; the Council on Cardiopulmonary, Perioperative, and Critical Care; the Council on Clinical Cardiology; and the Stroke Council Circulation, December 2, 2008; 118(23): 2452 - 2483. [Full Text] [PDF]
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R. J. Myerburg Implantable Cardioverter-Defibrillators after Myocardial Infarction N. Engl. J. Med., November 20, 2008; 359(21): 2245 - 2253. [Full Text] [PDF]
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M. R. Gold, J. H. Ip, O. Costantini, J. E. Poole, S. McNulty, D. B. Mark, K. L. Lee, and G. H. Bardy Role of Microvolt T-Wave Alternans in Assessment of Arrhythmia Vulnerability Among Patients With Heart Failure and Systolic Dysfunction: Primary Results From the T-Wave Alternans Sudden Cardiac Death in Heart Failure Trial Substudy Circulation, November 11, 2008; 118(20): 2022 - 2028. [Abstract] [Full Text] [PDF]
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S. Tzeis, G. Andrikopoulos, C. Kolb, and P. E. Vardas Tools and strategies for the reduction of inappropriate implantable cardioverter defibrillator shocks Europace, November 1, 2008; 10(11): 1256 - 1265. [Abstract] [Full Text] [PDF]
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C. N. Pellegrini, K. Lee, J. E. Olgin, M. P. Turakhia, Z. H. Tseng, R. Lee, N. Badhwar, B. Lee, and P. D. Varosy Impact of advanced age on survival in patients with implantable cardioverter defibrillators Europace, November 1, 2008; 10(11): 1296 - 1301. [Abstract] [Full Text] [PDF]
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J. K. Triedman Should patients with congenital heart disease and a systemic ventricular ejection fraction less than 30% undergo prophylactic implantation of an ICD?: Implantable Cardioverter Defibrillator Implantation Guidelines Based Solely on Left Ventricular Ejection Fraction Do Not Apply to Adults With Congenital Heart Disease Circ Arrhythm Electrophysiol, October 1, 2008; 1(4): 307 - 316. [Full Text] [PDF]
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Authors/Task Force Members, K. Dickstein, A. Cohen-Solal, G. Filippatos, J. J.V. McMurray, P. Ponikowski, P. A. Poole-Wilson, A. Stromberg, D. J. van Veldhuisen, D. Atar, et al. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM) Eur. Heart J., October 1, 2008; 29(19): 2388 - 2442. [Full Text] [PDF]
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R. Tung, P. Zimetbaum, and M. E. Josephson A Critical Appraisal of Implantable Cardioverter-Defibrillator Therapy for the Prevention of Sudden Cardiac Death J. Am. Coll. Cardiol., September 30, 2008; 52(14): 1111 - 1121. [Abstract] [Full Text] [PDF]
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A. E. Epstein Benefits of the Implantable Cardioverter-Defibrillator J. Am. Coll. Cardiol., September 30, 2008; 52(14): 1122 - 1127. [Abstract] [Full Text] [PDF]
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L. Ding, W. Hua, H. Niu, K. Chen, and S. Zhang Primary prevention of sudden cardiac death using implantable cardioverter defibrillators Europace, September 1, 2008; 10(9): 1034 - 1041. [Abstract] [Full Text] [PDF]
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A. E. Epstein, J. P. DiMarco, K. A. Ellenbogen, N.A. M. Estes III, R. A. Freedman, L. S. Gettes, A. M. Gillinov, G. Gregoratos, S. C. Hammill, D. L. Hayes, et al. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices) Developed in Collaboration With the American Association for Thoracic Surgery and Society of Thoracic Surgeons J. Am. Coll. Cardiol., May 27, 2008; 51(21): e1 - e62. [Full Text] [PDF]
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A. E. Epstein, J. P. DiMarco, K. A. Ellenbogen, N.A. Mark Estes III, R. A. Freedman, L. S. Gettes, A. M. Gillinov, G. Gregoratos, S. C. Hammill, D. L. Hayes, et al. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices) Developed in Collaboration With the American Association for Thoracic Surgery and Society of Thoracic Surgeons J. Am. Coll. Cardiol., May 27, 2008; 51(21): 2085 - 2105. [Full Text] [PDF]
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Writing Committee Members, A. E. Epstein, J. P. DiMarco, K. A. Ellenbogen, N.A. M. Estes III, R. A. Freedman, L. S. Gettes, A. M. Gillinov, G. Gregoratos, S. C. Hammill, et al. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices): Developed in Collaboration With the American Association for Thoracic Surgery and Society of Thoracic Surgeons Circulation, May 27, 2008; 117(21): 2820 - 2840. [Full Text] [PDF]
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Writing Committee Members, A. E. Epstein, J. P. DiMarco, K. A. Ellenbogen, N.A. M. Estes III, R. A. Freedman, L. S. Gettes, A. M. Gillinov, G. Gregoratos, S. C. Hammill, et al. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices): Developed in Collaboration With the American Association for Thoracic Surgery and Society of Thoracic Surgeons Circulation, May 27, 2008; 117(21): e350 - e408. [Full Text] [PDF]
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H. J. Wellens Forty Years of Invasive Clinical Electrophysiology: 1967-2007 Circ Arrhythm Electrophysiol, April 1, 2008; 1(1): 49 - 53. [Full Text] [PDF]
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T. Rossenbacker, S. G. Priori, and D. P. Zipes The fight against sudden cardiac death: consensus guidelines as a reference Eur. Heart J. Suppl., December 1, 2007; 9(suppl_I): I50 - I58. [Abstract] [Full Text] [PDF]
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W. Jung and B. Schumacher What is the role of risk stratification for sudden death in the defibrillator era? Eur. Heart J. Suppl., December 1, 2007; 9(suppl_I): I59 - I65. [Abstract] [Full Text] [PDF]
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D. J. Callans Patients With Hemodynamically Tolerated Ventricular Tachycardia Require Implantable Cardioverter-Defibrillators Circulation, September 4, 2007; 116(10): 1196 - 1203. [Full Text] [PDF]
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J. Almendral and M. E. Josephson All Patients With Hemodynamically Tolerated Postinfarction Ventricular Tachycardia Do Not Require an Implantable Cardioverter-Defibrillator Circulation, September 4, 2007; 116(10): 1204 - 1212. [Full Text] [PDF]
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R. Passman and A. Kadish Sudden Death Prevention With Implantable Devices Circulation, July 31, 2007; 116(5): 561 - 571. [Full Text] [PDF]
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C. S. Simpson MD Implantable cardioverter defibrillators work so why aren't we using them? Can. Med. Assoc. J., July 3, 2007; 177(1): 49 - 51. [Full Text] [PDF]
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J. S. Healey, A. P. Hallstrom, K.-H. Kuck, G. Nair, E. P. Schron, R. S. Roberts, C. A. Morillo, and S. J. Connolly Role of the implantable defibrillator among elderly patients with a history of life-threatening ventricular arrhythmias Eur. Heart J., July 2, 2007; 28(14): 1746 - 1749. [Abstract] [Full Text] [PDF]
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A. Jahangir, D. J. Bradley, and W. K. Shen ICDs for secondary prevention of sudden death in the older-elderly Eur. Heart J., July 2, 2007; 28(14): 1665 - 1667. [Full Text] [PDF]
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S. S. Chugh, K. Reinier, and E. C. Stecker Learning From a Real-World Analysis of Implantable Cardioverter-Defibrillator Recipients: Comorbidities Matter J. Am. Coll. Cardiol., June 26, 2007; 49(25): 2416 - 2418. [Full Text] [PDF]
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D. S. Lee, J. V. Tu, P. C. Austin, P. Dorian, R. Yee, A. Chong, D. A. Alter, and A. Laupacis Effect of Cardiac and Noncardiac Conditions on Survival After Defibrillator Implantation J. Am. Coll. Cardiol., June 26, 2007; 49(25): 2408 - 2415. [Abstract] [Full Text] [PDF]
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A. E. Epstein, C. A. Baessler, A. B. Curtis, N.A. M. Estes III, B. J. Gersh, B. Grubb, and L. B. Mitchell Addendum to "Personal and Public Safety Issues Related to Arrhythmias That May Affect Consciousness: Implications for Regulation and Physician Recommendations: A Medical/ Scientific Statement From the American Heart Association and the North American Society of Pacing and Electrophysiology" Public Safety Issues in Patients With Implantable Defibrillators A Scientific Statement From the American Heart Association and the Heart Rhythm Society Circulation, March 6, 2007; 115(9): 1170 - 1176. [Abstract] [Full Text] [PDF]
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A. K. Gehi, D. Mehta, and J. A. Gomes Evaluation and Management of Patients After Implantable Cardioverter-Defibrillator Shock JAMA, December 20, 2006; 296(23): 2839 - 2847. [Abstract] [Full Text] [PDF]
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V. J. Dzau, E. M. Antman, H. R. Black, D. L. Hayes, J. E. Manson, J. Plutzky, J. J. Popma, and W. Stevenson The Cardiovascular Disease Continuum Validated: Clinical Evidence of Improved Patient Outcomes: Part II: Clinical Trial Evidence (Acute Coronary Syndromes Through Renal Disease) and Future Directions Circulation, December 19, 2006; 114(25): 2871 - 2891. [Full Text] [PDF]
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Developed in Collaboration With the European Heart, D. P. Zipes, A. J. Camm, M. Borggrefe, A. E. Buxton, B. Chaitman, M. Fromer, G. Gregoratos, G. Klein, A. J. Moss, et al. ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death--Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Develop Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death) J. Am. Coll. Cardiol., September 5, 2006; 48(5): 1064 - 1108. [Full Text] [PDF]
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Developed in Collaboration With the European Heart, D. P. Zipes, A. J. Camm, M. Borggrefe, A. E. Buxton, B. Chaitman, M. Fromer, G. Gregoratos, G. Klein, A. J. Moss, et al. ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: A Report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Develop Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death) J. Am. Coll. Cardiol., September 5, 2006; 48(5): e247 - e346. [Full Text] [PDF]
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D. P. Zipes, D. P. Zipes, A. J. Camm, M. Borggrefe, A. E. Buxton, B. Chaitman, M. Fromer, G. Gregoratos, G. Klein, A. J. Moss, et al. ACC/AHA/ESC 2006 guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death--executive summary: A report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Develop Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death) Developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Eur. Heart J., September 1, 2006; 27(17): 2099 - 2140. [Full Text] [PDF]
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 F. S. Luyster, J. W. Hughes, D. Waechter, and R. Josephson Resource loss predicts depression and anxiety among patients treated with an implantable cardioverter defibrillator. Psychosom Med, September 1, 2006; 68(5): 794 - 800. [Abstract] [Full Text] [PDF]
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Writing Committee Members, D. P. Zipes, A. J. Camm, M. Borggrefe, A. E. Buxton, B. Chaitman, M. Fromer, G. Gregoratos, G. Klein, A. J. Moss, et al. ACC/AHA/ESC 2006 guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: A report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Develop Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death) Developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society Europace, September 1, 2006; 8(9): 746 - 837. [Full Text] [PDF]
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J. Zwanziger, W. J. Hall, A. W. Dick, H. Zhao, A. I. Mushlin, R. M. Hahn, H. Wang, M. L. Andrews, C. Mooney, H. Wang, et al. The Cost Effectiveness of Implantable Cardioverter-Defibrillators: Results From the Multicenter Automatic Defibrillator Implantation Trial (MADIT)-II J. Am. Coll. Cardiol., June 6, 2006; 47(11): 2310 - 2318. [Abstract] [Full Text] [PDF]
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S. Nisam and G. Breithardt Lessons learned from neutral ICD trials Europace, June 1, 2006; 8(6): 393 - 397. [Abstract] [Full Text] [PDF]
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P. A. Gould, A. D. Krahn, and for the Canadian Heart Rhythm Society Working Grou Complications associated with implantable cardioverter-defibrillator replacement in response to device advisories. JAMA, April 26, 2006; 295(16): 1907 - 1911. [Abstract] [Full Text] [PDF]
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D. A. Cesario and G. W. Dec Implantable Cardioverter- Defibrillator Therapy in Clinical Practice J. Am. Coll. Cardiol., April 18, 2006; 47(8): 1507 - 1517. [Abstract] [Full Text] [PDF]
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Z. Goldberger and R. Lampert Implantable Cardioverter-Defibrillators: Expanding Indications and Technologies JAMA, February 15, 2006; 295(7): 809 - 818. [Abstract] [Full Text] [PDF]
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J. R. Paisey, A. M. Yue, F. Bessoule, P. R. Roberts, and J. M. Morgan Passive electrode effect reduces defibrillation threshold in bi-filament middle cardiac vein defibrillation. Europace, February 1, 2006; 8(2): 113 - 117. [Abstract] [Full Text] [PDF]
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D. M. Bloomfield, J. T. Bigger, R. C. Steinman, P. B. Namerow, M. K. Parides, A. B. Curtis, E. S. Kaufman, J. M. Davidenko, T. S. Shinn, and J. M. Fontaine Microvolt T-Wave Alternans and the Risk of Death or Sustained Ventricular Arrhythmias in Patients With Left Ventricular Dysfunction J. Am. Coll. Cardiol., January 17, 2006; 47(2): 456 - 463. [Abstract] [Full Text] [PDF]
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S. J. Connolly, P. Dorian, R. S. Roberts, M. Gent, S. Bailin, E. S. Fain, K. Thorpe, J. Champagne, M. Talajic, B. Coutu, et al. Comparison of {beta}-Blockers, Amiodarone Plus {beta}-Blockers, or Sotalol for Prevention of Shocks From Implantable Cardioverter Defibrillators: The OPTIC Study: A Randomized Trial JAMA, January 11, 2006; 295(2): 165 - 171. [Abstract] [Full Text] [PDF]
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M. Abello, J. L. Merino, R. Peinado, M. Gnoatto, M. A. Arias, M. Gonzalez-Vasserot, and J. A. Sobrino Syncope following cardioverter defibrillator implantation in patients with spontaneous syncopal monomorphic ventricular tachycardia Eur. Heart J., January 1, 2006; 27(1): 89 - 95. [Abstract] [Full Text] [PDF]
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Part 4: Advanced Life Support Circulation, November 29, 2005; 112(22_suppl): III-25 - III-54. [Full Text] [PDF]
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