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478167361 Page 1 of 37 WORKSHEET for PROPOSED Evidence-Based GUIDELINE RECOMMENDATIONS NOTE: Save worksheet using the following filename format: Taskforce.Topic.Author.Date.Doc where Taskforce is a=ACLS, b=BLS, p=Pediatric, n=neonatal and i=Interdisciplinary. Use 2 or 3 letter abbreviation for author’s name and 30Jul03 as sample date format. Worksheet Author: Nabil El Sanadi Author’s Home Resuscitation Council: CLAR IAHF Taskforce/Subcommittee: ACLS Date Submitted to Subcommittee: 13AUG04, Revised 22OCT04; Revised 10DEC04 STEP 1: STATE THE PROPOSAL. State if this is a proposed new guideline; revision to current guideline; or deletion of current guideline. Existing guideline, practice or training activity, or new guideline: Revisions: Guidelines 2000 for Cardiopulmonary for Resuscitation and Emergency Cardiovascular Care: Circulation 2000, (Supplement) Vol. I (8) Chapter: Section 8; Section 5 Part 6 Pages: I-166-167; I-120, 121, and 123 Existing Guideline: “If the arrest rhythm was VF or VT and no antiarrhythmic treatment was given, consider use of Lidocaine followed by maintenance infusion unless contraindicated (i.e., in patients with ventricular escape rhythm) and continue the infusion for several hours while primary ventricular fibrillation secondary to an acute coronary syndrome is excluded and other correctable causes are assessed. Clinicians should consider the precipitating cause of the cardiac arrest, particularly an AMI, electrolyte disturbances, or primary arrhythmias. If an antiarrhythmic agent was used successfully during the resuscitation, administer a continuous infusion of that agent.” Step 1A: Refine the question; state the question as a positive (or negative) hypothesis. State proposed guideline recommendation as a specific, positive hypothesis. Use single sentence if possible. Include type of patients; setting (in- /out-of-hospital); specific interventions (dose, route); specific outcomes (ROSC vs. hospital discharge). Anti-Arrhythmic use Post Cardiac-Arrest, will Prevent Cardiac Rhythm Deterioration to Non-Life Sustaining Rhythms. Step 1B: Gather the Evidence; define your search strategy. Describe search results; describe best sources for evidence. Key Words Used: –Post-Cardiac Arrest/ Anti-Arrhythmic –Post-Cardiac Arrest/ Arrhythmia –Unstable/Post-Arrest/ Anti-Arrhythmic List electronic databases searched (at least AHA EndNote 7 Master library [http://ecc.heart.org/], Cochrane database for systematic reviews and Central Register of Controlled Trials [http://www.cochrane.org/], MEDLINE [http://www.ncbi.nlm.nih.gov/PubMed/ ], and Embase), and hand searches of journals, review articles, and books. Electronic Data Bases Searched: Cochrane, Medline, Embase and AHA Endnote Library. • State major criteria you used to limit your search; state inclusion or exclusion criteria (e.g., only human studies with control group? no animal studies? N subjects > minimal number? type of methodology? peer-reviewed manuscripts only? no abstract-only studies?) Search Limited By: Human Studies, No Animal Studies, Peer-Reviewed Manuscript, Review Articles, English, Book Chapter (Guidelines 2000 for C.P.R. and E.C.C.) • Number of articles/sources meeting criteria for further review: Create a citation marker for each study (use the author initials and date or Arabic numeral, e.g., “Cummins-1”). . If possible, please supply file of best references; EndNote 6+ required as reference manager using the ECC reference library. Total Article 483; 448 Excluded; 35 Studies Met Criteria for Detailed Review . STEP 2: ASSESS THE QUALITY OF EACH STUDY Step 2A: Determine the Level of Evidence. For each article/source from step 1, assign a level of evidence—based on study design and methodology. Level of Definitions Evidence (See manuscript for full details) Randomized clinical trials or meta-analyses of multiple clinical trials with substantial treatment effects Level 1 Randomized clinical trials with smaller or less significant treatment effects Level 2 Prospective, controlled, non-randomized, cohort studies Level 3 Historic, non-randomized, cohort or case-control studies Level 4 Case series: patients compiled in serial fashion, lacking a control group Level 5 Animal studies or mechanical model studies Level 6 Extrapolations from existing data collected for other purposes, theoretical analyses Level 7 Rational conjecture (common sense); common practices accepted before evidence-based guidelines Level 8 478167361 Page 2 of 37 Step 2B: Critically assess each article/source in terms of research design and methods. Was the study well executed? Suggested criteria appear in the table below. Assess design and methods and provide an overall rating. Ratings apply within each Level; a Level 1 study can be excellent or poor as a clinical trial, just as a Level 6 study could be excellent or poor as an animal study. Where applicable, please use a superscripted code (shown below) to categorize the primary endpoint of each study. For more detailed explanations please see attached assessment form. Component of Study and Rating Design & Methods Excellent Highly appropriate sample or model, randomized, proper controls AND Outstanding accuracy, precision, and data collection in its class A = Return of spontaneous circulation B = Survival of event Good Highly appropriate sample or model, randomized, proper controls OR Outstanding accuracy, precision, and data collection in its class Fair Adequate, design, but possibly biased Poor Small or clearly biased population or model Unsatisfactory Anecdotal, no controls, off target end-points OR Adequate under the circumstances OR Weakly defensible in its class, limited data or measures OR Not defensible in its class, insufficient data or measures C = Survival to hospital discharge D = Intact neurological survival E = Other endpoint Step 2C: Determine the direction of the results and the statistics: supportive? neutral? opposed? DIRECTION of study by results & statistics: Results SUPPORT the proposal Outcome of proposed guideline superior, to a clinically important degree, to current approaches NEUTRAL Outcome of proposed guideline no different from current approach OPPOSE the proposal Outcome of proposed guideline inferior to current approach Step 2D: Cross-tabulate assessed studies by a) level, b) quality and c) direction (ie, supporting or neutral/ opposing); combine and summarize. Exclude the Poor and Unsatisfactory studies. Sort the Excellent, Good, and Fair quality studies by both Level and Quality of evidence, and Direction of support in the summary grids below. Use citation marker (e.g. author/ date/source). In the Neutral or Opposing grid use bold font for Opposing studies to distinguish them from merely neutral studies. Where applicable, please use a superscripted code (shown below) to categorize the primary endpoint of each study. Supporting Evidence Quality of Evidence Anti-Arrhythmic use Post Cardiac-Arrest will Prevent Cardiac Rhythm Deterioration to Non-Life Sustaining Rhythms. Excellent Good Bokhari 2004E Buxton 2000E Buxton 1999B Cappato2004 Dorian 2002B Kuck 2000B Kudenchuk 1999 #22B Becker 2003E MartinezRubio 2003B Schmitt 2001B Boutitie 1999E Connolly 2000 Ellison 2002 Farre 2000E Werner 2004C,D Wilson 1998C,D Kudenchuk 1999 #21E Kudenchuk 1999 #23E Goldberger 2000E Naccarelli 1998E Naccarelli 2000 478167361 Page 3 of 37 Cappato 1999E Cannom 1998E Capucci 2001E Doggrell 2001E Ezekowitz 2003E Hilleman 2001E Reddy 1999E Trappe 2003E Fair Ellison 2002E 1 2 3 4 5 6 Auer 2001 Fogel 2000 Saksena 1998 Windhagen 2000 Zivin 1999 7 8 Level of Evidence A = Return of spontaneous circulation B = Survival of event C = Survival to hospital discharge D = Intact neurological survival E = Other endpoint Italics = studies address related topics Neutral or Opposing Evidence Anti-Arrhythmic use Post Cardiac-Arrest will Prevent Cardiac Rhythm Deterioration to Non-Life Sustaining Rhythms. Quality of Evidence Excellent Good Schull 2000C Fair 1 2 3 4 5 6 7 8 Level of Evidence A = Return of spontaneous circulation B = Survival of event C = Survival to hospital discharge D = Intact neurological survival E = Other endpoint Italics = studies address related topics STEP 3. DETERMINE THE CLASS OF RECOMMENDATION. Select from these summary definitions. CLASS Class I Definitely recommended. Definitive, excellent evidence provides support. Class II: Acceptable and useful • Class IIa: Acceptable and useful Good evidence provides support • Class IIb: Acceptable and useful Fair evidence provides support CLINICAL DEFINITION • Always acceptable, safe • Definitely useful • Proven in both efficacy & effectiveness • Must be used in the intended manner for proper clinical indications. • Safe, acceptable • Clinically useful • Not yet confirmed definitively • Safe, acceptable • Clinically useful • Considered treatments of choice • Safe, acceptable • Clinically useful • Considered optional or alternative REQUIRED LEVEL OF EVIDENCE • One or more Level 1 studies are present (with rare exceptions) • Study results consistently positive and compelling • Most evidence is positive • Level 1 studies are absent, or inconsistent, or lack power • No evidence of harm • Generally higher levels of evidence • Results are consistently positive • Generally lower or intermediate levels of evidence • Generally, but not consistently, positive results 478167361 Class III: Not acceptable, not useful, may be harmful Indeterminate Page 4 of 37 treatments • Unacceptable • Not useful clinically • May be harmful. • Research just getting started. • Continuing area of research • No recommendations until further research • No positive high level data • Some studies suggest or confirm harm. • Minimal evidence is available • Higher studies in progress • Results inconsistent, contradictory • Results not compelling STEP 3: DETERMINE THE CLASS OF RECOMMENDATION. State a Class of Recommendation for the Guideline Proposal. State either a) the intervention, and then the conditions under which the intervention is either Class I, Class IIA, IIB, etc.; or b) the condition, and then whether the intervention is Class I, Class IIA, IIB, etc. Intervention Anti-Arrhythmic use Post Cardiac-Arrest will Prevent Cardiac Rhythm Deterioration to Non-Life Sustaining Rhythms. Class IIB-Acceptable & Useful; fair evidence REVIEWER’S PERSPECTIVE AND POTENTIAL CONFLICTS OF INTEREST: Briefly summarize your professional background, clinical specialty, research training, AHA experience, or other relevant personal background that define your perspective on the guideline proposal. List any potential conflicts of interest involving consulting, compensation, or equity positions related to drugs, devices, or entities impacted by the guideline proposal. Disclose any research funding from involved companies or interest groups. State any relevant philosophical, religious, or cultural beliefs or longstanding disagreements with an individual. Emergency Physician practicing for 22 years in teaching facilities; Voluntary Professor of Medicine at the University of Miami, Florida; A.H.A. Regional Faculty; E.M.S. Medical Director/Advisor for 22 years. No conflict of interest. REVIEWER’S FINAL COMMENTS AND ASSESSMENT OF BENEFIT / RISK: Summarize your final evidence integration and the rationale for the class of recommendation. Describe any mismatches between the evidence and your final Class of Recommendation. “Mismatches” refer to selection of a class of recommendation that is heavily influenced by other factors than just the evidence. For example, the evidence is strong, but implementation is difficult or expensive; evidence weak, but future definitive evidence is unlikely to be obtained. Comment on contribution of animal or mechanical model studies to your final recommendation. Are results within animal studies homogeneous? Are animal results consistent with results from human studies? What is the frequency of adverse events? What is the possibility of harm? Describe any value or utility judgments you may have made, separate from the evidence. For example, you believe evidence-supported interventions should be limited to in-hospital use because you think proper use is too difficult for pre-hospital providers. Please include relevant key figures or tables to support your assessment. •There are no level 1-8 studies that specifically and directly address the prophylactic use of IMMEDIATE post-arrest anti-arrhythmic therapy. •The optimal use of post cardiac arrest anti-arrhythmic therapy (drugs or defibrillation) has not been defined yet by clinical studies in humans. •There are several related studies/articles that: - Support the use of Amiodarone as the agent of choice (Auer, 2001 #1; Boutitie, 1999 #4; Doggrell, 2001 #12; Goldberg, 2000 #18; Kudenchuk,1999 #21; Kudenchuk, 1999 #22;Kudenchuk, 1999 #22; Naccarelli, 2000 #26; Trappe, 2003 #31). - Support the use of I.C.D as the superior modality (Buxton, 2000 #6; Cannom, 1998 #7; Cappato, 1999 #8; Cappato, 2004 #9; Connolly, 2000 #11; Ezekowitz, 2003 #15; Fogel, 2000 #17; Kuck, 2000 #20; Werner, 2004#32; Wilson, 1998 #33). - Support the use of guided therapy (i.e., E.P. or P.V.S Studies) to determine optimal therapy (anti-arrhythmic and/ or I.C.D.) prior to patient discharge from the hospital (Bokhari, 2004 #3;Buxton, 1999 #4; Capucci, 2000 #10; Hilleman, 2001 #19; Reddy,1999 #27; Schmitt, 2001 #29; Windhagen-Mahnert, 2000 #34; Zivin, 1999 #35). ●MartA-nez-Rubio, 2003 #24, et.al. Advocate the use of Automatic External Monitor Cardioverter-Defibrillator. A fully automatic device which shortens the time-to-treatment of arrhythmias for patients admitted to cardiac monitoring units. 117 patients were monitored; 1,988 episodes were recorded; with: - True Negative n= 1,454 - True Positive n= 499 - False Positive n= 35 (all caused by T-wave over-sensing while Ventricular Pacing, during Electro-Physiological 478167361 Page 5 of 37 Testing). - False Negatives n= 0 study strongly supports the notion that rapid diagnosis and treatment (mean response time 14.4 seconds) of post cardiac arrest arrhythmias are feasible and safe using Automatic External Cardioverter-Defibrillator. - This Opposing Schull, 2000 #30, et.al. Focus on cost effectiveness of use of telemetry units without sufficient differentiation regarding “reason for admission”. Their conclusion is that fewer patients, can be admitted to telemetry units safely. Preliminary draft/outline/bullet points of Guidelines revision: Include points you think are important for inclusion by the person assigned to write this section. Use extra pages if necessary. There are no level 1-8 studies that specifically and directly address the prophylactic use of IMMEDIATE post-arrest antiarrhythmic therapy. I. -Evidence from 2 level 2 studies (Dorian et.al… and Kudenchuck et.al…) and several theoretical extrapolations (level 7) suggest that Amiodarone resulted in a higher rate of survival to hospital admission for cardiac arrest patients when compared to Lidocaine: -Therefore administration of Amiodarone if the arrest rhythm was V.F. or V.T. and NO antiarrhythmic treatment was given should be considered as the treatment of choice (instead of Lidocaine) (Class IIB). Publication: Guidelines 2000 for Cardiopulmonary for Resuscitaion and Emergency Cardiovascular Care: Circulation 2000, (Supplement) Vol. I (5) Chapter: Section (5) Pages: I-123 Topic and Subheading: Pharmacology I: Agents for Arrhythmias/ Lidocaine (New Language Bolded) Administrating a continuous infusion of (prophylactic) antiarrhythmic agents to maintain circulation AFTER it has been successfully restored is controversial. However, until data is available supporting the prophylactic administration of antiarrhythmic agents after return of circulation, it is reasonable to continue and infusion of the drug associated with the restoration of a stable rhythm (Class Indeterminate). Publication: Guidelines 2000 for Cardiopulmonary for Resuscitaion and Emergency Cardiovascular Care: Circulation 2000, (Supplement) Vol. I (5) Chapter: Section (5) Pages: I-120 and 121 Topic and Subheading: Pharmacology I: Agents for Arrhythmias/ Amiodarone (IV) (New Language Bolded) Add the following to the Section: If the arrest rhythm was for V.T. and NO antiarrhythmic treatment was given, consider use of Amiodarone followed by maintence infusion unless coutraindicated, and continue the infusion for several hours while primary V.F. secondary to Acute Coronary Syndrome is excluded and correctable causes are assessed. II. -Evidence from level 2 and level 3 studies (including: Martinez-Rubio et.al… and Kuck et. al… ) and 29 additional supporting and related studies (L.O.E. 2-8); Support the notion that A.I.C.D. and Automatic External Monitor Cardioverter-Defibrillator are superior to drug therapy alone for post cardiac arrest patients. -Therefor the Automatic External Monitor Cardioverter-Defibrillator is highly recommended (II-B) to insure rapid cardioversion defibrillation of potentially non-life sustaining rhythms; For post cardiac arrest patients out-of-hospital and in-hospital. Publication: Guidelines 2000 for Cardiopulmonary for Resuscitation and Emergency Cardiovascular Care: Circulation 2000, (Supplement) Vol. I (8) Chapter: Section 8 Pages: I-166-167 Topic and Subheading: Postresuscitation Care/ Optimal Response to Resuscitation (New Language Bolded) a) If the arrest rhythm was VF or VT and no antiarrhythmic treatment was given, consider use of Amiodarone (Eliminate Lidocaine) followed by maintenance infusion unless contraindicated (i.e., in patients with ventricular escape rhythm) and continue the infusion for several hours while primary ventricular fibrillation secondary to an acute coronary syndrome is excluded and other correctable causes are assessed. Clinicians should consider the precipitating cause of the cardiac arrest, particularly an AMI, electrolyte disturbances, or primary arrhythmias. If an antiarrhythmic agent was used successfully during the resuscitation, administer a continuous infusion of that agent. b) Add the following to the section: The use of Automatic External Monitor Cardioverter-Defibrillator is highly recommended (IIB) to insure rapid Cardioversion-Defibrillation of Potentially Non-Life Sustaining Rhythms for Post Cardiac Arrest Patients Out-of-Hospital and In-Hospital. 478167361 Page 6 of 37 478167361 Page 7 of 37 Citation List No studies specifically addressed hypothesis (all addressed related topics, as detailed below) Citation Marker [Auer, 2001 #1] [Becker, 2003 #2] [Bokhari, 2004 #3] Full Citation* Auer, J., R. Berent, et al. (2001). "Amiodarone. Renaissance of an antiarrhythmic drug?" Internistische Praxis 41(2): 387-394. Amiodarone has originally been designed and introduced into cardiac therapy as an antiischemic drug. Today it represents the antiarrhythmic drug most frequently prescribed in Europe with a rate of 34,5%. The prescription rate of amiodarone for treatment of arrhythmias, like atrial fibrillation, ventricular tachycardia and after cardiac arrest due to ventricular fibrillation or ventricular tachycardia is increasing rapidly. L.O.E. =8, Fair, Related, Supportive. States that Amiodarone is being used more frequently post cardiac arrest. Becker, R., M. Melkumov, et al. (2003). "Are electrophysiological studies needed prior to defibrillator implantation?" PACE - Pacing and Clinical Electrophysiology 26(8): 1715-1721. At present, patients with documented sustained VT or resuscitated cardiac arrest (CA) are treated with ICDs. The aim of this study was to retrospectively evaluate if a routine electrophysiological study should be recommended prior to ICD implantation. In 462 patients referred for ICD implantation because of supposedly documented VT (n = 223) or CA (n = 239), electrophysiological study was routinely performed. In 48% of the patients with CA, sustained VT or VF was inducible. Electrophysiological study suggested conduction abnormalities (n = 11) or supraventricular tachyarrhythmias (n = 3) in conjunction with severely impaired left ventricular function to have been the most likely cause of CA in 14 (5.9%) of 239 patients. Likewise, sustained VT was only inducible in 48% of patients with supposedly documented VT. Of these inducible VTs, nine were diagnosed as right ventricular outflow tract tachycardia or as bundle branch reentry tachycardia. Supraventricular tachyarrhythmias judged to represent the clinical event were the only inducible arrhythmia in 35 (16%) patients (AV nodal reentrant tachycardia [n = 7], AV reentry tachycardia [n = 4], atrial flutter [n = 19], and atrial tachycardia [n = 5]). Based on findings from the electrophysiological study, ICD implantation was withheld in 14 (5.9%) of 239 patients with CA and in 44 (19.7%) of 223 patients with supposedly documented VT. During electrophysiological study, VT or VF was only reproducible in about 50% of patients with supposedly documented VT or CA. Electrophysiological study revealed other, potentially curable causes for CA or supposedly documented VT in 12.6% (58/462) of all patients, indicating that ICD implantation can potentially be avoided or at least postponed in some of these patients. Based on these retrospective data, routine electrophysiological study prior to ICD implantation seems to be advisable. L.O.E. =4, Good, Related, Supportive. A retrospective study suggesting that electrophysiological study prior to I.C.D. implantation is advisable. Bokhari, F., D. Newman, et al. (2004). "Long-term comparison of the implantable cardioverter defibrillator versus amiodarone: Eleven-year follow-up of a subset of patients in the Canadian Implantable Defibrillator Study (CIDS)." Circulation 110(2): 112-116. The implantable cardioverter defibrillator (ICD) is superior to amiodarone for secondary prophylaxis of sudden cardiac death. However, the magnitude of this benefit over long-term follow-up is not known. Thus, our objective was to evaluate the long-term consequences of using amiodarone versus an ICD as first-line monotherapy in patients with a prior history of sustained ventricular tachycardia/ventricular fibrillation or cardiac arrest. Methods and Results - A total of 120 patients were enrolled at St Michael's Hospital in the Canadian Implantable Defibrillator Study (CIDS) and were randomly assigned to receive either amiodarone (n=60) or an ICD (n=60). The treatment strategy was not altered after the end of CIDS unless the initial assigned therapy was not effective or was associated with serious side effects. After a mean follow-up of 5.6(plus or minus)2.6 years, there were 28 deaths (47%) in the amiodarone group, compared with 16 deaths (27%) in the ICD group (P=0.0213). Total mortality was 5.5% per year in the amiodarone group versus 2.8% per year in the ICD group (hazard ratio of amiodarone: ICD, 2.011; 95% confidence interval, 1.087 to 3.721; P=0.0261). In the amiodarone group, 49 patients (82% of all patients) had side effects related to amiodarone, of which 30 patients (50% of all patients) required discontinuation or dose reduction; 19 patients crossed over to ICD because of amiodarone failure (n=7) or side effects (n= 12). Conclusions - In a subset of CIDS, the benefit of the ICD over amiodarone increases with time; most amiodarone-treated patients eventually develop side effects, have arrhythmia recurrences, or die. L.O.E. =2, Good, Related, Supporting. The benefit of I.C.D. over Amiodarone increases with time. The majority of Amiodarone-treated patients developed side effects, have arrhythmia reoccurrence or died. [Boutitie, 1999 #4] Boutitie, F., J.-P. Boissel, et al. (1999). "Amiodarone interaction with (beta)-blockers: Analysis of the merged EMIAT (European Myocardial Infarct Amiodarone Trial) and CAMIAT (Canadian Amiodarone Myocardial Infarction Trial) databases." Circulation 99(17): 2268-2275. Background - Investigations With in vitro and animal models suggest an interaction between amiodarone and (beta)-blockers. The objective of this work was to explore if an interaction with (beta)-blocker treatment plays a role in the decrease of cardiac arrhythmic deaths with amiodarone in patients recovered from an acute myocardial infarction. Methods and Results - A pooled database from 2 similar randomized clinical trials, the European Amiodarone Myocardial Infarction Trial (EMIAT) and the Canadian Amiodarone 478167361 Page 8 of 37 Myocardial Infarction Trial (CAMIAT), was used. Four groups of post-myocardial infarction patients were defined: (beta)-blockers and amiodarone used, (beta)- blockers used alone, amiodarone used alone, and neither used. All analyses were done on an intention-to-treat basis. Unadjusted and adjusted relative risks for all-cause mortality, cardiac death, arrhythmic cardiac death, nonarrhythmic cardiac death, arrhythmic death, or resuscitated cardiac arrest were lower for patients receiving (beta)-blockers and amiodarone than for those without (beta)-blockers, with or without amiodarone. The interaction was statistically significant for cardiac death and arrhythmic death or resuscitated cardiac arrest (P=0.05 and 0.03, respectively). Findings were consistent across subgroups. Conclusions - These findings are based on a post hoc analysis. However, they confirm prior results from in vitro and animal experiments suggesting an interaction between (beta)-blockers and amiodarone. In practice, not only is the adjunct of amiodarone to (beta)-blockers not hazardous, but (beta)-blocker therapy should be continued if possible in patients in whom amiodarone is indicated. L.O.E. = 4, Good, Related, Supportive. Suggesting that combined therapy of beta-blockers and Amiodarone is not only NOT harmful, but may be benefical long term therapy. [Buxton, 1999 #5] Buxton, A. E., K. L. Lee, et al. (1999). A randomized study of the prevention of sudden death in patients with coronary artery disease. Multicenter Unsustained Tachycardia Trial Investigators. New England journal of medicine. 341: 1882-1890. BACKGROUND: Empirical antiarrhythmic therapy has not reduced mortality among patients with coronary artery disease and asymptomatic ventricular arrhythmias. Previous studies have suggested that antiarrhythmic therapy guided by electrophysiological testing might reduce the risk of sudden death. METHODS: We conducted a randomized, controlled trial to test the hypothesis that electrophysiological guided antiarrhythmic therapy would reduce the risk of sudden death among patients with coronary artery disease, a left ventricular ejection fraction of 40 percent or less, and asymptomatic, unsustained ventricular tachycardia. Patients in whom sustained ventricular tachyarrhythmias were induced by programmed stimulation were randomly assigned to receive either antiarrhythmic therapy, including drugs and implantable defibrillators, as indicated by the results of electrophysiologic testing, or no antiarrhythmic therapy. Angiotensin-converting-enzyme inhibitors and beta-adrenergic-blocking agents were administered if the patients could tolerate them. RESULTS: A total of 704 patients with inducible, sustained ventricular tachyarrhythmias were randomly assigned to treatment groups. Five-year Kaplan-Meier estimates of the incidence of the primary end point of cardiac arrest or death from arrhythmia were 25 percent among those receiving electrophysiologically guided therapy and 32 percent among the patients assigned to no antiarrhythmic therapy (relative risk, 0.73; 95 percent confidence interval, 0.53 to 0.99), representing a reduction in risk of 27 percent). The five-year estimates of overall mortality were 42 percent and 48 percent, respectively (relative risk, 0.80; 95 percent confidence interval, 0.64 to 1.01). The risk of cardiac arrest or death from arrhythmia among the patients who received treatment with defibrillators was significantly lower than that among the patients discharged without receiving defibrillator treatment (relative risk, 0.24; 95 percent confidence interval, 0.13 to 0.45; P<0.001). Neither the rate of cardiac arrest or death from arrhythmia nor the overall mortality rate was lower among the patients assigned to electrophysiologically guided therapy and treated with antiarrhythmic drugs than among the patients assigned to no antiarrhythmic therapy. CONCLUSIONS: Electrophysiologically guided antiarrhythmic therapy with implantable defibrillators, but not with antiarrhythmic drugs, reduces the risk of sudden death in high-risk patients with coronary disease. L.O.E. =2, Good, Related, Supportive. Suggesting electrophysiological guided I.C.D. therapy reduces the risk of sudden death. [Buxton, 2000 #6] Buxton, A. E., K. L. Lee, et al. (2000). "Electrophysiologic testing to identify patients with coronary artery disease who are at risk for sudden death." New England Journal of Medicine 342(26): 1937-1945. Background: The mortality rate among patients with coronary artery disease, abnormal ventricular function, and unsustained ventricular tachycardia is high. The usefulness of electrophysiologic testing for risk stratification in these patients is unclear. Methods: We performed electrophysiologic testing in patients who had coronary artery disease, a left ventricular ejection fraction of 40 percent or less, and asymptomatic, unsustained ventricular tachycardia. Patients in whom sustained ventricular tachyarrhythmias could be induced were randomly assigned to receive either antiarrhythmic therapy guided by electrophysiologic testing or no antiarrhythmic therapy. The primary end point was cardiac arrest or death from arrhythmia. Patients without inducible tachyarrhythmias were followed in a registry. We compared the outcomes of 1397 patients in the registry with those of 353 patients with inducible tachyarrhythmias who were randomly assigned to receive no antiarrhythmic therapy in order to assess the prognostic value of electrophysiologic testing. Results: Patients were followed for a median of 39 months. In a Kaplan-Meier analysis, two-year and five-year rates of cardiac arrest or death due to arrhythmia were 12 and 24 percent, respectively, among the patients in the registry, as compared with 18 and 32 percent among the patients with inducible tachyarrhythmias who were assigned to no antiarrhythmic therapy (adjusted P<0.001). Overall mortality after five years was 48 percent among the patients with inducible tachyarrhythmias, as compared with 44 percent among the patients in the registry (adjusted P= 0.005). Deaths among patients without inducible tachyarrhythmias were less likely to be classified as due to arrhythmia than those among patients with inducible tachyarrhythmias (45 and 54 percent, respectively; P=0.06). Conclusions: Patients with coronary artery disease, left ventricular dysfunction, and asymptomatic, unsustained ventricular tachycardia in whom sustained ventricular tachyarrhythmias cannot be induced have a significantly lower risk of sudden death or cardiac arrest and lower overall mortality than similar patients with inducible sustained tachyarrhythmias. (C)2000, Massachusetts Medical Society. 478167361 Page 9 of 37 L.O.E. =2, Good, Related, Supportive. Suggesting that patients with C.A.D. and left ventricular dysfunction who have inducible sustained tachyarrhythmias have a higher mortality rate than similar patients with noninducible sustaine tachyarrhythmias. [Cannom, 1998 #7] Cannom, D. S. (1998). "AVID and beyond: Lessons learned." Journal of Interventional Cardiology 11(3): 217226. The implantable cardioverter defibrillator (ICD) has been approved by the Food and Drug Administration (FDA) since 1985 and is widely used in practice. Until recently, however, the efficacy of the ICD has depended on a large published series of retrospective studies analyzing ventricular tachycardia and fibrillation patients. The recently published Antiarrhythmics Versus Implantable Defibrillator (AVID) trial is the first prospective randomized trial to show clearly that the ICD is more effective than drug therapy (amiodarone or sotalol) in patients who have survived an out-of- hospital cardiac arrest or have syncopal or hemodynamically significant ventricular tachycardia. The survival advantages probably hold true only for patients with an ejection fraction under 35% who have either coronary disease or other forms of cardiomyopathy. The survival advantage in this trial - which was halted prematurely because of the results noted - was short-lived (2.8 months) and expensive. The results of this trial will clearly define the role of the ICD in everyday clinical practice and will be of invaluable benefit to patients, physicians, and insurers alike. The results of the AVID trial, as well as other postevent and pre-event trials, are summarized in this article. A number of substudies have already resulted from the AVID study and are also presented. L.O.E. =7, Good, Related, Supportive. Suggesting that A.I.C.D. is superior to Amiodarone or Sotalol Drug Therapy. [Cappato, 1999 #8] Cappato, R. (1999). "Secondary prevention of sudden death: The Dutch study, the antiarrhythmics versus implantable defibrillator trial, the cardiac arrest study Hamburg, and the Canadian implantable defibrillator study." American Journal of Cardiology 83(5 B): 68D-73D. Although indisputably effective in the prevention of sudden death, use of implantable cardioverter defibrillator (ICD) therapy may not necessarily affect all-cause mortality, as most patients at risk also present with severely depressed left ventricular dysfunction. Correction of the sudden death risk in these patients creates a new clinical condition in need of a careful assessment. Should all-cause mortality be affected by the expected reduction in sudden death rate associated with ICD therapy, issues of critical importance, such as the time extent of life prolongation and the associated quality of life, still remain to established. To investigate the potential benefit of ICD therapy compared with antiarrhythmic drug treatment, 4 prospective studies-the Dutch trial, the Antiarrhythmics Versus Implantable Defibrillators (AVID) study, the Cardiac Arrest Study Hamburg (CASH), and the Canadian Implantable Defibrillator Study (CIDS)-have been conducted in which patients with documented sustained ventricular arrhythmia were randomized to 1 of these 2 treatment strategies. The enrollment criteria differed in these 4 studies: (1) in the Dutch trial, they included cardiac arrest secondary to a ventricular arrhythmia, old (>4 weeks) myocardial infarction, and inducible ventricular arrhythmia; (2) in AVID and CIDS, ventricular fibrillation or poorly tolerated ventricular tachycardia; and (3) in CASH, cardiac arrest secondary to a ventricular arrhythmia regardless of the underlying disease. With regard to the antiarrhythmic drugs, the Dutch trial tested class I and III agents, whereas AVID and CIDS compared ICD therapy with class III agents (mostly amiodarone). In CASH, 3 drug subgroups were investigated: propafenone, amiodarone, and metoprolol. All trials used all-cause mortality as the primary endpoint. Data from these trials provide support for ICD as a therapy superior to antiarrhythmic drugs in prolonging survival in patients meeting the entry criteria. This review briefly summarizes the methods, results, limitations, and clinical implications of these 4 studies. L.O.E. =7, Fair, Related, Supportive. Suggesting that A.I.C.D. is superior to antiarrhythmic drugs. [Cappato, 2004 #9] Cappato, R., S. Boczor, et al. (2004). "Response to programmed ventricular stimulation and clinical outcome in cardiac arrest survivors receiving randomised assignment to implantable cardioverter defibrillator or antiarrhythmic drug therapy." European Heart Journal 25(8): 642-649. Background: Using a prospective design which randomly assigned implantable cardioverter defibrillator (ICD) versus antiarrhythmic drugs (AADs), we investigated the usefulness of programmed ventricular stimulation (PVS) for prediction of outcome and therapy effectiveness in cardiac arrest (CA) survivors. Methods and results: We performed baseline PVS in 285 survivors of CA enrolled in the Cardiac Arrest Study Hamburg (CASH) and randomised to ICDs or AADs. Sustained ventricular arrhythmia (VA) was induced in 134 (47.0%) patients. We compared the outcomes of different subgroups based on response to baseline PVS and randomly assigned therapy. Patients were followed for a median of 55 months. The raw death rate was greater among inducible (51.3% [95% CI: 44.9-58.3%]) than non-inducible patients (28.8% [CI: 23.4-36.1%, p = 0.0003]). When challenged in a multivariate model, inducibility still had an independent power for predicting all-cause death (hazard ratio (HR), 1.5 [95% CI, 1.1-2.3], p = 0.041), but not sudden death (SD) (HR, 1.2 [95% CI, 0.7-3.6], p = 0.162). Subgroup analysis showed that, when compared to AADs, assignment to ICDs was associated with a lower risk of all-cause death (HR, 0.4 [95% CI, 0.1-0.9], p = 0.044) in patients with EF (less-than or equal to) 0.35 and non-inducible arrhythmias, but not in other patient subgroups. Conclusions: In CA survivors, inducibility at baseline PVS is Independently associated with an increased risk of all-cause death, but not SD. In addition, response to PVS may help to identify subgroups of patients who could most benefit from ICD. (copyright) 2004 The European Society of Cardiology. Published by Elsevier Ltd. All rights reserved. 478167361 Page 10 of 37 L.O.E. =2, Good, Related, Supportive. Suggesting that P.V.S. can better direct the use of I.C.D. to prevent sudden death. [Capucci, 2000 #10] [Connolly, 2000 #11] [Doggrell, 2001 #12] Capucci, A., D. Aschieri, et al. (2000). The role of EP-guided therapy in ventricular arrhythmias: betablockers, sotalol, and ICD's. Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing. 4 Suppl 1: 57-63. Arrhythmic death can be reduced by antiarrhythmic drugs to a range of 24%. Electrophysiologic study by testing noninducibility of ventricular arrhythmia represents the classic method for evaluating the effectiveness of drug therapy.Several clinical studies have shown thaat sotalol suppresses VT induction and prevents arrhythmias recurrences at long term follow-up in 23% to 67% of patients. The efficacy of sotalol EP guided therapy in preventing VT/VF is not necessarily related to prevention of sudden death. In the ESVEM study the superiority of d,l-sotalol to other antiarrhythmic drugs was confirmed. The response to programmed ventricular stimulation was found to be strongly predictive for arrhythmia free state while the failure of sotalol therapy to suppress VT at the EP study was associated with an high recurrence rate (40%). However, EP study failes to predict freedom from sudden death. The beta-blocking activity of racemic sotalol may account for some of the observed survival benefit.Beta-blockers therapy reduces mortality in patients after myocardial infarction primarily by a reduction of sudden death. A reduction of death, worsening heart failure and life threatening ventricular arrhythmias was shown in a recent study on carvedilol. In the prospective study of Steinbeck the EP guided-therapy did not improve the overall outcome when compared to metoprolol. Suppression of inducible arrhythmias by antiarrhythmic drugs was associated with a better outcome. The effectiveness of defibrillator therapy in reducing overall mortality, has been uncertain since great clinical trials have been concluded. MADIT, AVID and CASH trials confirmed the superiority of ICD therapy over antiarrhythmic drugs therapy: ICD should be considered the first choice therapy in post-cardiac arrest patients.The ongoing BEST Trial will give us further responses about the interaction between EP study and metoprolol effect compared to ICD in patients post myocardial infarction also focusing on tolerability and compliance of the beta-blocking therapy in patients with low ejection fraction. In this study will be useful to optimize therapy in patients at high risk of sudden death. L.O.E. =7, Fair, Related, Supportive. Suggesting that I.C.D. should be considered as the first and choice therapy for post cardiac arrest patients. Connolly, S. J., A. P. Hallstrom, et al. (2000). "Metal-analysis of the implantable cardioverter defibrillator secondary prevention trials." European Heart Journal 21(24): 2071-2078. Aims: Three randomized trials of implantable cardioverter defibrillator (ICD) therapy vs medical treatment for the prevention of death in survivors of ventricular fibrillation or sustained ventricular tachycardia have been reported with what might appear to be different results. The present analysis was performed to obtain the most precise estimate of the efficacy of the ICD, compared to amiodarone, for prolonging survival in patients with malignant ventricular arrhythmia. Methods and Results: Individual patient data from the Antiarrhythmics vs Implantable Defibrillator (AVID) study, the Cardiac Arrest Study Hamburg (CASH) and the Canadian Implantable Defibrillator Study (CIDS) were merged into a master database according to a prespecified protocol. Proportional hazard modelling of individual patient data was used to estimate hazard ratios and to investigate subgroup interactions. Fixed effect meta-analysis techniques were also used to evaluate treatment effects and to assess heterogeneity across studies. The classic fixed effects meta-analysis showed that the estimates of ICD benefit from the three studies were consistent with each other (P heterogeneity=0.306). It also showed a significant reduction in death from any cause with the ICD; with a summary hazard ratio (ICD:amiodarone) of 0.72 (95% confidence interval 0.60, 0.87; P=0.0006). For the outcome of arrhythmic death, the hazard ratio was 0.50 (95% confidence interval 0.37, 0.67; P<0.0001). Survival was extended by a mean of 4.4 months by the ICD over a follow-up period of 6 years. Patients with left ventricular ejection fraction (greater-than or equal to)35% derived significantly more benefit from ICD therapy than those with better preserved left ventricular function. Patients treated before the availability of non-thoracotomy ICD implants derived significantly less benefit from ICD therapy than those treated in the non-thoracotomy era. Conclusion: Results from the three trials of the ICD vs amiodarone are consistent with each other. There is a 28% reduction in the relative risk of death with the ICD that is due almost entirely to a 50% reduction in arrhythmic death. (C) 2000 The European Society of Cardiology. L.O.E. =4, Good, Related, Supportive. Suggesting that I.C.D. is superior (28% reduction in the relative risk of arrhythmia death) to Amiodarone. Doggrell, S. A. (2001). Amiodarone -- waxed and waned and waxed again. Expert opinion on pharmacotherapy. 2: 1877-1890. Amiodarone has been used as an anti-arrhythmic drug since the 1970s and has an established role in the treatment of ventricular tachyarrhythmias. Although considered to be a class III anti-arrhythmic, amiodarone also has class I, II and IV actions, which gives it a unique pharmacological and anti-arrhythmic profile. Amiodarone is a structural analogue of thyroid hormone and some of its anti-arrhythmic properties and toxicity may be attributable to interactions with nuclear thyroid hormone receptors. The lipid solubility of amiodarone gives it an exceptionally long half-life. Oral amiodarone takes days to work in ventricular tachyarrhythmias, but iv. amiodarone has immediate effect and can be used in life threatening ventricular arrhythmias. Intravenous amiodarone administered after out-of-hospital cardiac arrest due to ventricular fibrillation improves survival to hospital admission. Many survivors of myocardial infarction (MI) die during 478167361 Page 11 of 37 the subsequent year, probably due to ventricular arrhythmia. Amiodarone reduces sudden death after MI and this benefit is predominantly observed in patients with preserved cardiac function. Sudden cardiac death, predominantly due to ventricular arrhythmias, is also commonly seen in patients with heart failure. The Grupo de Estudio de la Sobrevida en lsuficiencia Cardiaca en Argentina (GESICA) and Estudio Piloto Argentino de Muerte Subita y Amiodarona (EPAMSA) trials showed survival benefit of amiodarone in heart failure, whereas Congestive Heart Failure-Survival Trial of Anti-arrhythmic Therapy (CHF-STAT) did not. Subsequent meta-analysis established a survival benefit of amiodarone in heart failure. Implanted Cardioverter Def ibrillators (ICDs) also give survival benefit to patients at risk of sudden death. In patients with a history of ventricular fibrillation or haemodynamically-compromising ventricular tachycardia, ICDs have been shown to be superior to anti-arrhythmic drugs, principally amiodarone. Further analysis has been undertaken to ascertain which patients are most likely to benefit from ICDs, as these are more expensive than treatment with amiodarone. Patients with severely depressed ejection fractions should be the first to be considered for ICDs. A new indication for amiodarone is atrial fibrillation or flutter. Amiodarone is effective in chronic and recent onset atrial fibrillation and orally or iv. for atrial fibrillation after heart surgery. In atrial fibrillation amiodarone is more than or equi-effective with flecainide, quinidine, racemic sotalol, propafenone and diltiazem and therefore should be considered for first line therapy. Amiodarone is also safe and effective in controlling refractory tachyarrhythmias in infants and is safe after cardiac surgery. L.O.E. =7, Fair, Related, Supportive. Suggesting that Amiodarone is a usefull antiarrhythmic agent; however I.C.D. is the treatment of choice for patients with severly depressed ejection fraction. [Dorian, 2002 #13] [Ellison, 2002 #14] Dorian, P., D. Cass, et al. (2002). "Amiodarone as compared with lidocaine for shock-resistant ventricular fibrillation." New England Journal of Medicine 346(12): 884-890. Background: Lidocaine has been the initial antiar-rhythmic drug treatment recommended for patients with ventricular fibrillation that is resistant to conversion by defibrillator shocks. We performed a randomized trial comparing intravenous lidocaine with intravenous amiodarone as an adjunct to defibrillation in victims of out-of-hospital cardiac arrest. Methods: Patients were enrolled if they had out-of-hospital ventricular fibrillation resistant to three shocks, intravenous epinephrine, and a further shock; or if they had recurrent ventricular fibrillation after initially successful defibrillation. They were randomly assigned in a double-blind manner to receive intravenous amiodarone plus lidocaine placebo or intravenous lidocaine plus amiodarone placebo. The primary end point was the proportion of patients who survived to be admitted to the hospital. Results: In total, 347 patients (mean [(plus or minus)SD] age, 67(plus or minus)14 years) were enrolled. The mean interval between the time at which paramedics were dispatched to the scene of the cardiac arrest and the time of their arrival was 7(plus or minus)3 minutes, and the mean interval from dispatch to drug administration was 25(plus or minus)8 minutes. After treatment with amiodarone, 22.8 percent of 180 patients survived to hospital admission, as compared with 12.0 percent of 167 patients treated with lidocaine (P=0.009; odds ratio, 2.17; 95 percent confidence interval, 1.21 to 3.83). Among patients for whom the time from dispatch to the administration of the drug was equal to or less than the median time (24 minutes), 27.7 percent of those given amiodarone and 15.3 percent of those given lidocaine survived to hospital admission (P=0.05). Conclusions: As compared with lidocaine, amiodarone leads to substantially higher rates of survival to hospital admission in patients with shock-resistant out-of-hospital ventricular fibrillation. Copyright (copyright) 2002 Massachusetts Medical Society. L.O.E. =2, Good, Related, Supportive. Suggesting that Amiodarone leads to substanically higher rates of survival, as compared with Lidocaine. Ellison, K. E., G. E. Hafley, et al. (2002). "Effect of (beta)-blocking therapy on outcome in the Multicenter Unsustained Tachycardia Trial (MUSTT)." Circulation 106(21): 2694-2699. Background - (beta)-Blockers are known to reduce total mortality and sudden death in survivors of recent myocardial infarction. The effects of these agents in patients at high risk for sudden death with remote infarction are not clear. Methods and Results - We analyzed the effect of (beta)-blockers on outcomes in 2096 patients with coronary artery disease, ejection fraction (less-than or equal to)40%, and spontaneous nonsustained ventricular tachycardia enrolled in the Multicenter UnSustained Tachycardia Trial (MUSTT). Forty-five percent of 702 patients with inducible sustained ventricular tachyarrhythmia and 35% of 1394 patients without inducible tachycardia were discharged from hospital receiving (beta)-blockers. Patients treated with (beta)-blockers were younger and had higher ejection fractions, higher rates of recent angina, and more recent infarction. (beta)-Blockers were associated with decreased total mortality for the entire study population (5-year mortality 50% with (beta)-blockers versus 66% without (beta)-blockers; adjusted P=0.0001). The mortality benefit associated with (beta)-blockers was present in patients with and without inducible tachycardia, except those treated with implantable defibrillators. There was no significant effect of (beta)-blocker therapy on the rate of arrhythmic death or cardiac arrest (adjusted P=0.2344). Conclusions (beta)-Blocking agents have beneficial effects on survival of patients having characteristics of those enrolled in the MUSTT trial. These effects do not appear to be due to a specific antiarrhythmic effect of (beta)blockers. The beneficial effects of (beta)-blockers were demonstrable in all patients except those treated with implantable defibrillators. L.O.E. =4, Good, Related, Supportive. Suggesting that beta blockers have a benefical effect on survivial, these effects do not appear to be due to a specific antiarrhythmic effect of (beta- blockers). Ezekowitz, J. A., P. W. Armstrong, et al. (2003). "Implantable cardioverter defibrillators in primary and 478167361 [Ezekowitz, 2003 #15] [Farre, 2000 #16] [Fogel, 2000 #17] [Goldberg, 2000#18] Page 12 of 37 secondary prevention: a systematic review of randomized, controlled trials." Annals of internal medicine 138(6): 445-452. BACKGROUND: Sudden cardiac death is common in persons with cardiovascular disease. PURPOSE: To assess the efficacy of implantable cardioverter defibrillators (ICDs) in persons at increased risk for sudden cardiac death. DATA SOURCES: MEDLINE (1980-2002), EMBASE (1980-2002), Cochrane Controlled Clinical Trial Registry (2002, Volume 3), other databases, and conference proceedings. Primary study authors and device manufacturers were contacted, and bibliographies of relevant papers were hand searched. STUDY SELECTION: Randomized, controlled clinical trials evaluating ICDs versus usual care were selected. DATA EXTRACTION: Two reviewers extracted data independently. DATA SYNTHESIS: Eight trials were included in the final analysis (4909 patients, 1154 deaths). Compared with usual care (most commonly amiodarone therapy), ICDs significantly reduced sudden cardiac death (relative risk [RR], 0.43 [95% CI, 0.35 to 0.53]) and all-cause mortality (RR, 0.74 [CI, 0.67 to 0.82]). The included trials were divided a priori into two categories: secondary prevention (involving patients resuscitated after cardiac arrest or unstable ventricular tachycardia or ventricular fibrillation [ n = 1963]) and primary prevention (involving patients at increased risk for sudden cardiac death but without documented cardiac arrest, ventricular fibrillation, or ventricular tachycardia [ n = 2946]). Regardless of baseline risk, ICDs were equally efficacious in preventing sudden cardiac death in both types of trials (RR, 0.50 [CI, 0.38 to 0.66] for secondary prevention vs. 0.37 [CI, 0.27 to 0.50] for primary prevention). However, the magnitude of benefit in total mortality varied within the primary prevention trials depending on baseline risk for sudden cardiac death. CONCLUSIONS: Implantable cardioverter defibrillators prevent sudden cardiac death regardless of baseline risk. However, their impact on total mortality is sensitive to baseline risk for arrhythmic death. Decisions about resource allocation for ICDs depend on accurate stratification of patients according to risk. L.O.E. =7, Fair, Related, Supportive. Suggesting that accurate patient risk stratification is essential to optimizing the use of I.C.D. Farre, J., J. A. Cabrera, et al. (2000). "Therapeutic decision tree for patients with sustained ventricular tachyarrhythmias or aborted cardiac arrest: A critical review of the antiarrhythmics versus implantable defibrillator trial and the Canadian implantable defibrillator study." American Journal of Cardiology 86(9 SUPPL. 1): 44K-51K. Antiarrhythmic drugs, mainly amiodarone and sotalol, radiofrequency catheter ablation, and the implantable cardioverter defibrillator (ICD) are the 3 therapeutic options in patients with sustained ventricular tachycardia (VT) or ventricular fibrillation (VF). Idiopathic VT, incessant VT, frequently recurring, hemodynamically stable VT, and VT based on bundle branch reentry, are candidates for radiofrequency catheter ablation. Patients with high-risk ventricular tachyarrhythmias should receive ICDs as initial therapy. Two studies, the Antiarrhythmics Versus Implantable Defibrillator trial (AVID) and the Canadian Implantable Defibrillator Study (CIDS) have tried to approach the problem of these high-risk ventricular tachyarrhythmias. Although at 3 years, the ICD in AVID demonstrated a significant relative risk reduction over amiodarone of 31.5%, CIDS could not duplicate this finding. At 3 years, the relative risk reduction conferred by the ICD over amiodarone in CIDS was only 13.7%. A careful analysis of both studies suggests that CIDS was insufficiently powered to demonstrate statistically significant benefits similar to those shown by AVID, and furthermore, seemed to include an undetermined number of low-risk VT patients. The problem in the CIDS trial in this regard was the recruitment of patients in whom the inclusion criteria were met by the arrhythmias induced during the electrophysiology stimulation study, but which did not exist in real life. In addition CIDS included 14% of patients with (1) undocumented syncope and inducible monomorphic sustained VT; or (2) long runs of spontaneous nonsustained VT. Under these circumstances, the therapeutic implications of AVID remain unchallenged. (C) 2000 by Excerpta Medica, Inc. L.O.E. =7, Fair, Related, Supportive. Suggesting that I.C.D. are superior to Amiodarone. Fogel, R. I. and E. N. Prystowsky (2000). Management of malignant ventricular arrhythmias and cardiac arrest. Critical care medicine. 28: N165-9. Sudden cardiac death continues to be a major health problem in the United States, accounting for approximately 400,000 deaths per year. The last 10 yrs have seen major advances in the primary and secondary prevention of this problem. In patients who have survived an episode of cardiac arrest, the AVID study conclusively established the superiority of the implantable cardioverter defibrillator over empiric amiodarone. For patients with recurrent hemodynamically destabilizing ventricular tachycardia and ventricular fibrillation, intravenous amiodarone has emerged as a potent therapeutic agent, especially when other agents such as lidocaine and procainamide have not been effective. Finally, recent work has focused on the risk stratification of patients for sudden cardiac death. Both the MADIT and MUSTT studies suggest that patients with coronary artery disease, reduced ejection fraction, and nonsustained ventricular tachycardia who are inducible to a sustained ventricular arrhythmia at electrophysiology testing have improved survival with an implantable cardioverter defibrillator. L.O.E. =8, Fair, Related, Supportive. Suggesting that risk stratification for S.C.D. is essential; and that I.C.D. are superior. Goldberger, J. J. and S. Neelagaru (2000). "Therapeutic developments in sudden cardiac death." Expert Opinion on Investigational Drugs 9(11): 2543-2554. Sudden cardiac death is characterised by the unexpected death of a patient who has been clinically 478167361 Page 13 of 37 stable. It is frequently due to the development of ventricular tachyarrhythmias. With appropriate treatment, patients can be appropriately resuscitated. Clinically, it is essential to develop treatment strategies to prevent such an episode, as most patients do not survive out-of-hospital cardiac arrest. (beta)-blockers are an effective pharmacological therapy in patients following myocardial infarction and in those with congestive heart failure. They may also be effective in other types of heart disease. Anti-arrhythmic agents are not useful as prophylactic drug therapy for reducing mortality in patients at risk for sudden cardiac death. Amiodarone is a notable exception, which may have some benefit, particularly in some subgroups. The implantable cardioverter-defibrillator has emerged as the most effective therapy for preventing sudden cardiac death in high-risk patients. Further work is required to enhance the characterisation of high-risk patients. Genetic analyses in patients with cardiovascular disorders may also identify new approaches to the prevention of sudden cardiac death. L.O.E. =8, Fair, Related, Supportive. Suggesting that antiarrhythmics can be given selectively with I.C.D. to maximize patient benefits. [Hilleman, 2001 #19] [Kuck, 2000 #20] Hilleman, D. E. and A. L. Bauman (2001). Role of antiarrhythmic therapy in patients at risk for sudden cardiac death: an evidence-based review. Pharmacotherapy. 21: 556-575. Sudden cardiac death (SCD) accounts for more than half of all cardiac deaths occurring each year in the United States. Although it has several causes, patients at greatest risk are those with coronary artery disease and impaired left ventricular function, heart failure secondary to ischemia or idiopathic dilated cardiomyopathy, hypertrophic cardiomyopathy, documented sustained ventricular tachycardia or ventricular fibrillation, and survivors of cardiac arrest. The presence of asymptomatic ventricular arrhythmias, positive signal-averaged electrocardiogram (ECG), low heart rate variability index, or inducible ventricular tachycardia or ventricular fibrillation increases the risk. In primary prevention trials in patients with ischemic heart disease, beta-blockers reduced both total mortality and SCD, whereas class I antiarrhythmic drugs, especially class IC, increased mortality. Among class III agents, d,l-sotalol and dofetilide have a neutral effect on mortality, whereas d-sotalol increases mortality. Amiodarone has a neutral effect on total and cardiac mortality but does reduce the risk of arrhythmic death and cardiac arrest. Three primary prevention trials in patients with ischemic heart disease were conducted with implantable cardioverter-defibrillators (ICDs). Patients with low ejection fractions (EFs), asymptomatic ventricular arrhythmias, and inducible ventricular tachycardia or ventricular fibrillation had significant reductions in total, cardiac, and arrhythmic death with ICDs compared with either no drug therapy or conventional antiarrhythmic agents. The ICDs did not reduce mortality in patients with low EFs and a positive signal-averaged ECG undergoing coronary bypass graft. In those with heart failure, beta-blockers reduced total and SCD mortality, but dofetilide and amiodarone had a neutral effect on mortality. In the secondary prevention of SCD, antiarrhythmic drugs alone generally are not thought to improve survival. In three trials in patients with documented sustained ventricular tachycardia or ventricular fibrillation, or survivors of SCD, ICDs reduced cardiac and arrhythmic mortality. Total mortality, however, was significantly reduced in only one of these trials. The role of antiarrhythmic drugs in secondary prevention of SCD is limited to patients in whom ICD is inappropriate or in combination with ICD. Antiarrhythmics can be given selectively with ICDs to decrease episodes of ventricular tachycardia or fibrillation to reduce ICD discharges, to suppress episodes of nonsustained ventricular tachycardia that trigger ICD discharges, to slow the rate of ventricular tachycardia to increase hemodynamic stability, to allow effective antitachycardia pacing, or to suppress supraventricular arrhythmias. L.O.E. =2, Good, Related, Supportive. Suggest that I.C.D. is superior to a combination of Amiodarone/ Metoprolol Therapy. Kuck, K. H., R. Cappato, et al. (2000). Randomized comparison of antiarrhythmic drug therapy with implantable defibrillators in patients resuscitated from cardiac arrest : the Cardiac Arrest Study Hamburg (CASH). Circulation. 102: 748-754. BACKGROUND: We conducted a prospective, multicenter, randomized comparison of implantable cardioverter-defibrillator (ICD) versus antiarrhythmic drug therapy in survivors of cardiac arrest secondary to documented ventricular arrhythmias. METHODS AND RESULTS: From 1987, eligible patients were randomized to an ICD, amiodarone, propafenone, or metoprolol (ICD versus antiarrhythmic agents randomization ratio 1:3). Assignment to propafenone was discontinued in March 1992, after an interim analysis conducted in 58 patients showed a 61% higher all-cause mortality rate than in 61 ICD patients during a follow-up of 11.3 months. The study continued to recruit 288 patients in the remaining 3 study groups; of these, 99 were assigned to ICDs, 92 to amiodarone, and 97 to metoprolol. The primary end point was all-cause mortality. The study was terminated in March 1998, when all patients had concluded a minimum 2-year follow-up. Over a mean follow-up of 57+/-34 months, the crude death rates were 36.4% (95% CI 26.9% to 46.6%) in the ICD and 44.4% (95% CI 37.2% to 51.8%) in the amiodarone/metoprolol arm. Overall survival was higher, though not significantly, in patients assigned to ICD than in those assigned to drug therapy (1sided P=0.081, hazard ratio 0.766, [97.5% CI upper bound 1.112]). In ICD patients, the percent reductions in all-cause mortality were 41.9%, 39.3%, 28. 4%, 27.7%, 22.8%, 11.4%, 9.1%, 10.6%, and 24.7% at years 1 to 9 of follow-up. CONCLUSIONS: During long-term follow-up of cardiac arrest survivors, therapy with an ICD is associated with a 23% (nonsignificant) reduction of all-cause mortality rates when compared with treatment with amiodarone/metoprolol. The benefit of ICD therapy is more evident during the first 5 years after the index event. L.O.E. =7, Fair, Supportive. Suggests that Amiodarone may be helpful in treating post-cardiac arrest 478167361 Page 14 of 37 arrhythmias. [Kudenchuk, 1999 #21] [Kudenchuk, 1999 #22] [Kudenchuk, 1999 #23] [MartA-nez-Rubio, 2003 #24] Kudenchuk, P. J. (1999). Intravenous antiarrhythmic drug therapy in the resuscitation from refractory ventricular arrhythmias. American journal of cardiology. 84: 52R-55r. Prompt cardiopulmonary resuscitation (CPR) and early defibrillation significantly improve the likelihood of successful resuscitation from cardiac arrest and are the key components in the American Heart Association's "chain of survival." Although representing current clinical practice in the United States, there is limited evidence supporting the benefit of acute administration of such antiarrhythmic medications as lidocaine, bretylium, magnesium, and procainamide to a victim of cardiac arrest. There has been only 1 published case-controlled clinical trial in which shock-refractory victims of out-of-hospital ventricular fibrillation were stratified into those who received lidocaine and those who did not. In this trial, no significant differences were observed between treatment groups in the return of an organized rhythm, admission to the hospital, or survival to hospital discharge. In the recently published ARREST trial, a significant improvement in admission alive to the hospital was observed in recipients of intravenous amiodarone, compared with placebo (44% vs 34%, respectively, p = 0.03). With the possible exception of intravenous amiodarone, available evidence of definitive benefit from antiarrhythmic drugs in cardiac arrest is inconclusive. Due to regulatory issues, clinical trials in cardiac arrest are extremely difficult to design and perform. L.O.E. =7, Fair, Related, Supportive. Suggests that Amiodarone May be helpful in treating post cardiac arrest arrhythmias. Kudenchuk, P. J., L. A. Cobb, et al. (1999). Amiodarone for resuscitation after out-of-hospital cardiac arrest due to ventricular fibrillation. New England journal of medicine. 341: 871-878. BACKGROUND: Whether antiarrhythmic drugs improve the rate of successful resuscitation after out-of-hospital cardiac arrest has not been determined in randomized clinical trials. METHODS: We conducted a randomized, double-blind, placebo-controlled study of intravenous amiodarone in patients with out-of-hospital cardiac arrest. Patients who had cardiac arrest with ventricular fibrillation (or pulseless ventricular tachycardia) and who had not been resuscitated after receiving three or more precordial shocks were randomly assigned to receive 300 mg of intravenous amiodarone (246 patients) or placebo (258 patients). RESULTS: The treatment groups had similar clinical profiles. There was no significant difference between the amiodarone and placebo groups in the duration of the resuscitation attempt (42+/-16.4 and 43+/-16.3 minutes, respectively), the number of shocks delivered (4+/-3 and 6+/-5), or the proportion of patients who required additional antiarrhythmic drugs after the administration of the study drug (66 percent and 73 percent). More patients in the amiodarone group than in the placebo group had hypotension (59 percent vs. 48 percent, P=0.04) or bradycardia (41 percent vs. 25 percent, P=0.004) after receiving the study drug. Recipients of amiodarone were more likely to survive to be admitted to the hospital (44 percent, vs. 34 percent of the placebo group; P=0.03). The benefit of amiodarone was consistent among all subgroups and at all times of drug administration. The adjusted odds ratio for survival to admission to the hospital in the amiodarone group as compared with the placebo group was 1.6 (95 percent confidence interval, 1.1 to 2.4; P=0.02). The trial did not have sufficient statistical power to detect differences in survival to hospital discharge, which differed only slightly between the two groups. CONCLUSIONS: In patients with out-of-hospital cardiac arrest due to refractory ventricular arrhythmias, treatment with amiodarone resulted in a higher rate of survival to hospital admission. Whether this benefit extends to survival to discharge from the hospital merits further investigation. L.O.E. =2, Good, Related, Supportive. Suggests Amiodarone resulted in a higher rate of survival to hospital admission for out-of-hospital cardiac arrest victims. Kudenchuk, P. J. and E. M. Racht (1999). Pharmacologic treatment of cardiac arrest. Prehospital emergency care : official journal of the National Association of EMS Physicians and the National Association of State EMS Directors. 3: 279-282. Antiarrhythmic drugs currently recommended in the American Heart Association's Advanced Cardiac Life Support (ACLS) guidelines for the treatment of cardiac arrest have not been proved in controlled clinical trials to improve survival in patients with ventricular fibrillation (VF) or pulseless ventricular tachycardia (VT). Intravenous amiodarone is a promising agent for the treatment of VF and VT. Based on available evidence, amiodarone should be considered for use in patients with shock-refractory ventricular arrhythmias. L.O.E. =7, Good, Related, Supportive. Suggesting that Amiodarone is affective in treating V.F. and V.T. MartÃ-nez-Rubio, A., N. Kanaan, et al. (2003). Advances for treating in-hospital cardiac arrest: safety and effectiveness of a new automatic external cardioverter-defibrillator. Journal of the American College of Cardiology. 41: 627-632. OBJECTIVES: The purpose of this study was to prospectively analyze the performance and safety of a new programmable, fully automatic external cardioverter-defibrillator (AECD) in a European multicenter trial. BACKGROUND Although, the response time to cardiac arrest (CA) is a major determinant of mortality and morbidity, in-hospital strategies have not significantly changed during the last 30 years. METHODS: Patients (n = 117) at risk of CA in monitored wards (n = 51) and patients undergoing electrophysiologic testing or implantable cardioverter-defibrillator (ICD) implantation (n = 66) were enrolled. The accuracy of the automatic response of the device to any change of rhythm (lasting >1 s and >4 beats) was confirmed by 478167361 Page 15 of 37 reviewing the simultaneously recorded Holter data and the programmed parameters. RESULTS: During 1,240 h, 1,988 episodes of rhythm changes were documented. A total of 115 episodes lasted > or =10 s or needed treatment (pacing, n = 32; ICD, n = 51; AECD, n = 35) for termination. The device detected ventricular tachyarrhythmias with a sensitivity of 100% and specificity of 97.6% (true negatives, n = 1,454; true positives, n = 499; false positives, n = 35; false negatives, n = 0). The false positives were all caused by T-wave oversensing during ventricular pacing. There were no complications or adverse events. The mean response time was 14.4 s for those episodes needing a full charge of the capacitor. CONCLUSIONS: This new AECD is safe and effective in detecting, monitoring, and treating spontaneous arrhythmias. This fully automatic device shortens the response time to treatment, and it is likely that it will significantly improve the outcome of patients with in-hospital CA. L.O.E. =3, Good, Supportive. The Automatic External Cardioverter-Defribillator (AECD) is effective in: monitoring, detecting and treating arrhythmias in monitored in-hospital patients; Significantly reducing the time to first shock for treatment of V.F. (14.4 seconds). [Naccarelli, 1998 #25] [Naccarelli, 2000 #26] [Reddy, 1999 #27] Naccarelli, G. V., D. L. Wolbrette, et al. (1998). "A decade of clinical trial developments in postmyocardial infarction, congestive heart failure, and sustained ventricular tachyarrhythmia patients: From CAST to AVID and beyond." Journal of Cardiovascular Electrophysiology 9(8): 864-891. Multiple trials using antiarrhythmic drugs, pharmacologic therapy, and implantable cardioverter defibrillators have been performed in an attempt to improve survival in patients: (1) postmyocardial infarction; (2) with congestive heart failure, with and without nonsustained ventricular tachycardia; and (3) with sustained ventricular tachycardia and those who have survived an out-of-hospital cardiac arrest. This article reviews some of the key findings and limitations of completed and ongoing trials. We also make recommendations for the current treatment of such patients based on the results of these trials. L.O.E. =7, Good, Related, Supportive. Review article recommending risk stratification and treatment strategies for post arrest arrhythmias. Naccarelli, G. V., D. L. Wolbrette, et al. (2000). Amiodarone: clinical trials. Current opinion in cardiology. 15: 64-72. Amiodarone is an antiarrhythmic agent commonly used in the treatment of supraventricular and ventricular tachyarrhythmias. This article reviews the results and clinical implications of primary and secondary prevention trials in which amiodarone was used in one of the treatment arms. Key post-myocardial infarction primary prevention trials include the European Myocardial Infarct Amiodarone Trial (EMIAT) and the Canadian Amiodarone Myocardial Infarction Trial (CAMIAT), both of which demonstrated that amiodarone reduced arrhythmic but not overall mortality. In congestive heart failure patients, amiodarone was studied as a primary prevention strategy in two pivotal trials: Grupo de Estudio de la Sobrevida en la Insuficiencia Cardiac en Argentina (GESICA) and Amiodarone in Patients With Congestive Heart Failure and Asymptomatic Ventricular Arrhythmia (CHF-STAT). Amiodarone was associated with a neutral overall survival and a trend toward improved survival in nonischemic cardiomyopathy patients in CHF/STAT and improved survival in GESICA. In post-myocardial infarction patients with nonsustained ventricular tachycardia and a depressed ejection fraction, the Multicenter Automatic Defibrillator Implantation Trial (MADIT) demonstrated that implantable cardioverter-defibrillators (ICD) statistically improved survival compared to the antiarrhythmic drug arm, most of whose patients were taking amiodarone. In patients with histories of sustained ventricular tachycardia or ventricular fibrillation, the Cardiac Arrest Study in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE) trial demonstrated that empiric amiodarone lowered arrhythmic recurrence rates compared to other drugs guided by serial Holter or electrophysiologic studies. However, arrhythmic death rates were high in both treatment arms of the study. Several secondary prevention trials, including the Antiarrhythmics Versus Implantable Defibrillators Study (AVID), the Canadian Implantable Defibrillator Study (CIDS), and the Cardiac Arrest Study Hamburg (CASH), have demonstrated the superiority of ICD therapy compared to empiric amiodarone in improving overall survival. Based on the above findings, amiodarone is safe to use in post-myocardial infarction and congestive heart failure patients that need antiarrhythmic therapy. Although amiodarone is effective in treating malignant arrhythmias, high-risk patients should be considered for an ICD as frontline therapy. L.O.E. =7, Good, Related, Supportive. Suggesting that I.C.D. should be used for high-risk patients. Amiodarone is safe to use in post-myocardical infarction and congestive heart failure patients that need anitarrhythmic therapy. Reddy, P. C., N. Tandon, et al. (1999). Ventricular tachycardia and sudden cardiac death. Journal of the Louisiana State Medical Society : official organ of the Louisiana State Medical Society. 151: 281-287. As we approach the new millennium, treatment of survivors of cardiac arrest and prevention of sudden cardiac death (SCD) are the two most important problems confronting contemporary cardiology practice. Sudden cardiac death occurs as a result of ventricular tachycardia (VT) degenerating into ventricular fibrillation (VF). Several major arrhythmia treatment trials completed during the last decade have significantly changed the way we treat patients with ventricular arrhythmias. In patients with sustained VT and aborted SCD, only treatment with implantable cardioverter defibrillator (ICD) has been shown to significantly increase survival. Amiodarone and sotalol, though very useful in the treatment of VT and VF, do not improve survival as significantly as ICD therapy. Use of Class I antiarrhythmics may adversely affect survival. Primary prevention of SCD in patients with a recent myocardial infarction (MI) and in patients with cardiomyopathy 478167361 Page 16 of 37 and congestive heart failure (CHF) is limited by our inability to accurately identify patients at risk of SCD. Among the many tests available to identify patients at risk of SCD, decreased left ventricular ejection fraction (LVEF) and presence of non-sustained VT appear to be most useful. To date, only beta adrenoceptor blockers have been shown to improve survival in post-MI patients as well as in patients with cardiomyopathy and CHF. Use of amiodarone is controversial in these patients. Treatment with ICD of post-MI patients with decreased LVEF and inducible sustained VT at electrophysiology study improves survival. L.O.E. =7, Fair, Related, Supportive. Treatment with I.C.D. of post-myocardial infarction patients with decreased LVEF and inducible sustained VT at electrophysiology study improves survival. [Saksena, 1998 #28] [Schmitt, 2001 #29] Saksena, S., P. Mathew, et al. (1998). "Implantable defibrillator therapy for the elderly." American Journal of Geriatric Cardiology 7(1): 11-13. The clinical application of ICD devices in the management of patients with ventricular tachyarrhythmias and cardiac arrest is rapidly expanding and is projected to exceed 50,000 implants annually within the next 5 years. Recent clinical trials have established superior clinical efficacy and safety with the ICD in these conditions as compared to currently available type 1 or type 3 antiarrhythmic drugs. Ventricular tachyarrhythmias are common in the elderly and most ICD centers have elderly patients. However, very limited clinical literature exists examining the specific considerations in implementing this therapy in the elderly patient and clinical expectations in this population. L.O.E. =7, Fair, Related, Supportive. Suggesting that better clinical stratification will lead to more “costeffective” use of I.C.D. Schmitt, C., P. Barthel, et al. (2001). Value of programmed ventricular stimulation for prophylactic internal cardioverter-defibrillator implantation in postinfarction patients preselected by noninvasive risk stratifiers. Journal of the American College of Cardiology. 37: 1901-1907. OBJECTIVES: The aim of this prospective study was to evaluate the role of programmed ventricular stimulation (PVS) after noninvasive risk stratification to identify a subgroup of acute myocardial infarction (AMI) survivors considered at risk for ventricular arrhythmias and whether these patients could benefit from internal cardioverter-defibrillators (ICDs). BACKGROUND: The predictive value of noninvasive and invasive risk stratifiers after AMI has been questioned. The question of whether the group of patients with inducible monomorphic ventricular tachycardia (VT) after AMI could profit from ICD implantation is unanswered. METHODS: A consecutive series of 1,436 AMI survivors was screened noninvasively by Holter monitoring, heart rate variability, ventricular late potentials, and ejection fraction. A subgroup of 248 patients (17.3%) were identified as high-risk patients and scheduled for PVS. Due to the study design, 54 patients >75 years were excluded; thus, 194 patients were eligible for PVS. Triple extrastimuli at two paced cycle lengths (600 ms and 400 ms) were applied. RESULTS: In a subgroup of 98 (51%) high-risk patients, PVS was performed; 21 patients had an abnormal response, and in 20 patients an ICD was implanted. During a mean follow-up of 607 days the arrhythmic event rate (sudden cardiac death, symptomatic VT, cardiac arrest) was 33% with a positive electrophysiological test versus 2.6% (p < 0.0001) with a negative electrophysiological test. A subgroup of 96 high-risk patients declined electrophysiological study. In this nonconsent group, cardiac mortality (combined sudden and nonsudden) was significantly higher (log-rank chi-square 9.38, p = 0.0022, relative risk 4.7, 1.6 to 13.9) compared to the group guided by electrophysiological testing and consecutive ICD implantation. CONCLUSIONS: After a two-step risk stratification, PVS is helpful in selecting a subgroup of AMI survivors without spontaneous ventricular arrhythmias who benefit from prophylactic ICD implantation. L.O.E. =3, Good, Related, Supportive. Suggesting that programmed ventricular stimulation is helpful in selecting appropriate A.M.I. survivors, without spontaneous arrhythmias, who would benefit from prophylactic I.C.D. implantation. [Schull, 2000 #30] Schull, M. J. and D. A. Redelmeier (2000). Continuous electrocardiographic monitoring and cardiac arrest outcomes in 8,932 telemetry ward patients. Academic emergency medicine : official journal of the Society for Academic Emergency Medicine. 7: 647-652. OBJECTIVE: To estimate the benefit of routine electrocardiographic (ECG) telemetry monitoring on in-hospital cardiac arrest survival. METHODS: In a tertiary care hospital, all telemetry ward admissions and cardiac arrests occurring over a five-year period were reviewed. Ward location and survival to discharge were determined for all patients outside of critical care areas. RESULTS: During the study period, 8,932 patients were admitted to the telemetry ward, and 20 suffered cardiac arrest (0.2%; 95% CI = 0.1 to 0.3). Telemetry monitors signaled the onset of cardiac arrest in only 56% (95% CI = 30 to 80) of monitored arrests. Three patients survived to discharge, and in two of these three patients the arrest onset was signaled by the monitor. This yields a monitor-signaled survival rate among telemetry ward patients of 0.02% (95% CI = 0 to 0.05). All survivors suffered significant arrhythmias prior to their cardiac arrests. CONCLUSIONS: Cardiac arrest is an uncommon event among telemetry ward patients, and monitor-signaled survivors are extremely rare. Routine telemetry offers little cardiac arrest survival benefit to most monitored patients, and a more selective policy for telemetry use might safely avoid ECG monitoring for many patients. L.O.E. =4, Good, Related, Opposing. Suggesting that hospital telemetry unit are over utilized; better admission triage should be implemented. [Trappe, 2003 #31] Trappe, H.-J., B. Brandts, et al. (2003). Arrhythmias in the intensive care patient. Current opinion in critical 478167361 Page 17 of 37 care. 9: 345-355. PURPOSE OF REVIEW: Atrial fibrillation, atrial flutter, AV-nodal reentry tachycardia with rapid ventricular response, atrial ectopic tachycardia, and preexcitation syndromes combined with atrial fibrillation or ventricular tachyarrhythmias are typical arrhythmias in intensive care patients. Most frequently, the diagnosis of the underlying arrhythmia is possible from the physical examination, the response to maneuvers or drugs, and the 12-lead surface electrocardiogram. In all patients with unstable hemodynamics, immediate DC-cardioversion is indicated. Conversion of atrial fibrillation to sinus rhythm is possible using antiarrhythmic drugs. Amiodarone has a conversion rate in atrial fibrillation of up to 80%. However, caution in the use of short-term administration of intravenous amiodarone in critically ill patients with recent-onset atrial fibrillation is absolutely necessary, and the duration of therapy should not exceed 24 to 48 hours. Ibutilide represents a relatively new class III antiarrhythmic agent that has been reported to have conversion rates of 50% to 70%; it seems that ibutilide is even successful when intravenous amiodarone failed to convert atrial fibrillation. RECENT FINDINGS: Newer studies compared the outcome of patients with atrial fibrillation and rhythm- or rate-control. Data from these studies (AFFIRM, RACE) clearly showed that rhythm control is not superior to rate control for the prevention of death and morbidity from cardiovascular causes. Therefore, rate-control may be an appropriate therapy in patients with recurrent atrial fibrillation after DCcardioversion. Acute therapy of atrial flutter in intensive care patients depends on the clinical presentation. Atrial flutter can most often be successfully cardioverted to sinus rhythm with energies less than 50 joules. Ibutilide trials showed efficacy rates of 38-76% for conversion of atrial flutter to sinus rhythm compared with conversion rates of 5-13% when intravenous flecainide, propafenone, or verapamil was administered. In addition, a high dose (2 mg) of ibutilide was more effective than sotalol (1.5 mg/kg) in conversion of atrial flutter to sinus rhythm (70% versus 19%). SUMMARY: There is general agreement that bystander first aid, defibrillation, and advanced life support is essential for neurologic outcome in patients after cardiac arrest due to ventricular tachyarrhythmias. The best survival rate from cardiac arrest can be achieved only when (1) recognition of early warning signs, (2) activation of the emergency medical services system, (3) basic cardiopulmonary resuscitation, (4) defibrillation, (5) management of the airway and ventilation, and (6) intravenous administration of medications occurs as rapidly as possible. Public access defibrillation, which places automatic external defibrillators in the hands of trained laypersons, seems to be an ideal approach in the treatment of ventricular fibrillation. The use of automatic external defibrillators by basic life support ambulance providers or first responder in early defibrillation programs has been associated with a significant increase in survival rates. Drugs such as lidocaine, procainamide, sotalol, amiodarone, or magnesium were recommended for treatment of ventricular tachyarrhythmias in intensive care patients. Amiodarone is a highly efficacious antiarrhythmic agent for many cardiac arrhythmias, ranging from atrial fibrillation to malignant ventricular tachyarrhythmias, and seems to be superior to other antiarrhythmic agents. L.O.E. =7, Fair, Related, Supportive. Suggesting that the A.H.A. Guidelines are effective in preventing brain deaths also Amiodarone is an effective antiarrhythmic agent. [Werner, 2004 #32] Werner, B., A. Przybylski, et al. (2004). Implantable cardioverter-defibrillators in children. Kardiologia polska. 60: 239-246. BACKGROUND: Implantable cardioverter-defibrillators (ICD) have been increasingly used in adult patients for the prevention of sudden cardiac death (SCD). The usefulness and feasibility of ICD implantation in children have been less well established. AIM: To analyse indications, results and safety of ICD therapy in children. METHODS: ICDs were implanted in seven children, aged from 6 to 17 years. All patients underwent cardiological evaluation which included analysis of medical history, physical examination, chest X-ray, standard ECG, 24-hour Holter ECG monitoring and echocardiography. RESULTS: In five children devices were implanted due to aborted sudden death (ventricular fibrillation) whereas in the remaining two - as a primary prevention of SCD. Three children had hypertrophic cardiomyopathy, one - dilated cardiomyopathy, one - mitral valve prolapse and QT prolongation, one - congenital long QT syndrome and the remaining patient - idiopathic ventricular tachycardia. Single-chamber devices were implanted in six children, and dualchamber system - in one patient. In all patients endocardial leads were implanted and ICD pocket was formed under the greater pectoral muscle. During follow-up ranging between four months to 5.4 years, four children developed ventricular fibrillation or ventricular tachycardia which were terminated by appropriate ICD discharges. CONCLUSIONS: 1. ICD implantation in children is effective in the prevention of SCD. 2. In our population, the most frequent indications for device implantation were life-threatening ventricular arrhythmias occurring in patients with cardiomyopathy. 3. Cardiac arrest due to ventricular fibrillation may occur in children without a history of aborted SCD. 4. ICD implantation in children is feasible and safe. L.O.E. =5, Good, Related, Supportive. (n=7) I.C.D. implantation in children is feasible and safe and is affective in preventing S.C.D. [Wilson, 1998 #33] Wilson, W. R., G. E. Greer, et al. (1998). Implantable cardioverter-defibrillators in children: a singleinstitutional experience. Annals of thoracic surgery. 65: 775-778. BACKGROUND: Implantable cardioverter-defibrillators have been infrequently used in children as therapy for resuscitated sudden death and syncope due to ventricular arrhythmias unresponsive to antiarrhythmics. METHODS: The medical records of 5 children with implantable cardioverter-defibrillators were retrospectively reviewed. All patients had experienced syncope and 3 (60%) an out-of-hospital cardiac arrest. Underlying pathology included hypertrophic cardiomyopathy in 2, long QT syndrome in 2, and 478167361 Page 18 of 37 ventricular arrhythmia after remote repair of congenital heart disease in 1. Open thoracotomy with epicardial lead placement and transvenous endocardial approaches were used. RESULTS: There was no early or late mortality in the 5 pediatric patients undergoing implantable cardioverter-defibrillator placement. Postoperative complications occurred more frequently when open thoracotomy was used for placement. At mean follow-up of 34 months, 4 of the 5 (80%) have received shocks. CONCLUSIONS: Implantable cardioverter-defibrillator is a safe and reliable therapy for children with resuscitated sudden death and syncope due to ventricular tachycardia unresponsive to antiarrhythmics. Transvenous lead placement lowers morbidity and hospital length of stay. L.O.E. =5, Good, Related, Supportive. (n=5) I.C.D. implantation in children is effective in preventing S.C.D. [Windhagen-Mahnert, 2000 #34] Windhagen-Mahnert, B. and A. H. Kadish (2000). Application of noninvasive and invasive tests for risk assessment in patients with ventricular arrhythmias. Cardiology clinics. 18: 243. Sudden cardiac death remains a major public health problem in western society. Because most patients who experience cardiac arrest are not successfully resuscitated, primary prevention of sudden death remains an important challenge. A number of noninvasive risk stratification techniques have been suggested as providing useful information in patients with underlying structural heart defects. Unfortunately, the positive predictive value of most of these techniques has been limited. Left ventricular ejection fraction, the presence of nonsustained ventricular tachycardia on Holter monitoring, and inducible sustained ventricular tachycardia at electrophysiologic testing in patients with coronary artery disease remain the best established prognostic test. However, with the exception of two ICD studies using the combination of these markers, prospective studies have not yet completely validated the use of these and other prognostic markers. Further understanding of the pathophysiology of ventricular fibrillation and other risk stratification techniques will be necessary before a clear algorithm can be developed for application to patients at risk for sudden death. L.O.E. =8, Fair, Related, Supportive. Suggesting that further development of stratification techniques is necessary before a clear therapy algorithm can be developed for application to patients at risk for sudden death. [Zivin, 1999 #35] Zivin, A. and G. H. Bardy (1999). Implantable defibrillators and antiarrhythmic drugs in patients at risk for lethal arrhythmias. American journal of cardiology. 84: 63R-68r. The high mortality rate and frequency of ventricular arrhythmias in patients with congestive heart failure has prompted numerous clinical trials aimed at reducing mortality by addressing arrhythmic death. Recently completed trials have suggested that for patients who have survived cardiac arrest, the preferred treatment may be an implantable cardioverter defibrillator (ICD). From the standpoint of primary prevention, implantable defibrillators and amiodarone have received the most attention. It remains unclear, however, to which patients these studies apply, and if and how the results might be generalized. No available studies confirm an additional benefit of pharmacologic or device-based antiarrhythmic therapy beyond that offered by optimal treatment with beta blockers, angiotensin-converting enzyme inhibitors, and lipid-lowering drugs in the majority of patients with cardiomyopathy. Clinical trials are ongoing to address these issues. L.O.E. =8, Fair, Related, Supportive. Suggests that more studies are necessary to better define the role of antiarrhythmic agents vs. I.C.D. for the treatment of patients at risk. 478167361 Page 19 of 37 Excluded References (448, with notes) (2000). "Part 6: Advance cardiovascular life support - Section 7: Algorithm approach to ACLS 7C: A guide to the international ACLS algorithms." Resuscitation 46(1-3): 169-184. (2000). Part 8: advanced challenges in resuscitation. Section 1: life-threatening electrolyte abnormalities. European Resuscitation Council. Resuscitation. 46: 253-259. (2003). 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