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At least 19 recordsLinked to original sources
PubMed1999

Navigation in the mega-trials waters: reflections on the Multicenter Automatic Defibrillator Implantation Trial and the Antiarrhythmics Versus Implantable Defibrillators Study.

Today, cardiology seems to be driven by mega-trials and meta-analyses. Guidelines published by scientific and professional cardiovascular societies, such as the American Heart Association, the American College of Cardiology, and the European Society of Cardiology, follow the rules of evidence-based medicine. Such evidence is not always sufficiently conclusive to practice clinically helpful medicine. Sometimes, relatively small trials, such as the Multicenter Automatic Defibrillator Implantation Trial and the Antiarrhythmics Versus Implantable Defibrillators study, may be taken as guides for current clinical decisions and as inspiration for future investigations. Large mega-trials with a great lack of homogeneity among the recruited patients are less important for clinically helpful medicine than studies enrolling well-defined, high-risk patients. It is probably important to acknowledge that the best possible treatment for many patients with ventricular tachyarrhythmias remains obscure. Among these situations are the following: (1) sustained ventricular tachycardia (VT) in patients without coronary artery disease; (2) sustained, nonsyncopal VT in patients with coronary artery disease and left ventricular dysfunction; (3) post myocardial infarction survivors with an ejection fraction < or = 35%, frequent/complex ventricular arrhythmias, depressed heart rate variability, and inducible sustained ventricular tachyarrhythmias during electrophysiologic study. Many studies are being conducted to add light where uncertainty exists, but probably only a few will contribute to the practice of clinically helpful medicine, although some will be used to produce meta-analysis to sustain evidence-based medicine.

Anti-Arrhythmia Agents↗
PubMed1997

Influence of patient characteristics in the selection of patients for defibrillator implantation (the AVID Registry). Antiarrhythmics Versus Implantable Defibrillators.

The Antiarrhythmics Versus Implantable Defibrillators (AVID) trial is a prospective, randomized study of treatment for life-threatening ventricular arrhythmias. Patients who are eligible for the main trial but who are not enrolled for any reason are followed in a registry. The objective of the present study was to determine whether there are identifiable patient characteristics among these registry patients that may influence whether a patient is treated with an implantable defibrillator. The 914 patients in the registry were divided into 2 groups according to whether the primary treatment was an implantable defibrillator. The mean age of defibrillator patients was 60 years, compared with 65 years in the nondefibrillator group (p <0.001). Only 11.2% of defibrillator recipients were minorities, whereas the percentage of minorities in the nondefibrillator group was 18.7% (p <0.003). A history of recurrent ventricular fibrillation was more likely in the group treated with defibrillators (8.9% vs 4.4%, p <0.01), whereas a history of atrial fibrillation or diabetes mellitus were both significantly more likely in the nondefibrillator group. Among defibrillator patients, a higher proportion had ventricular fibrillation as the index arrhythmia; patients with ventricular tachycardia were significantly more likely to be treated without devices. In this prospective but nonrandomized cohort of patients treated for life-threatening ventricular arrhythmias, older age, minority status, and comorbidity reduced the chances that a patient would be treated with a defibrillator.

Aged↗
PubMed2005

Factors influencing appropriate firing of the implanted defibrillator for ventricular tachycardia/fibrillation: findings from the Multicenter Automatic Defibrillator Implantation Trial II (MADIT-II).

OBJECTIVES: The purpose of this study was to prospectively examine the role of clinical, laboratory, echocardiographic, and electrophysiological variables as predictors of appropriate initial implantable cardioverter-defibrillator (ICD) therapy for ventricular tachycardia (VT) or ventricular fibrillation (VF) or death in the Multicenter Automatic Defibrillator Implantation Trial II (MADIT-II) population. BACKGROUND: There is limited information regarding the determinants of appropriate ICD therapy in patients with reduced ventricular function after a myocardial infarction. METHODS: We used secondary analysis in one arm of a multicenter randomized clinical trial in patients with a previous myocardial infarction and reduced left ventricular function. RESULTS: We analyzed baseline and follow-up data on 719 patients enrolled in the ICD arm of the MADIT-II study. Appropriate ICD therapy was observed in 169 subjects. Clinical, laboratory, echocardiographic, and electrophysiological variables, along with measures of clinical instability such as interim hospitalization for congestive heart failure (IH-CHF) and interim hospitalization for coronary events (IH-CE), were examined with proportional hazards models and Kaplan-Meier time-to-event curves before and after first interim hospitalization. Interim hospitalization-CHF, IH-CE, no beta-blockers, digitalis use, blood urea nitrogen (BUN) >25, body mass index (BMI) > or =30 kg/m2, and New York Heart Association functional class >II were associated with increased risk for appropriate ICD therapy for VT, VF, or death. In a multivariate (stepwise selection) analysis, IH-CHF was associated with an increased risk for the end point of either VT or VF (hazard ratio [HR] 2.52, 95% confidence interval [CI] 1.69 to 3.74, p < 0.001) and for the combined end point of VT, VF, or death (HR 2.97, 95% CI 2.15 to 4.09, p < 0.001). Interim hospitalization-CE was associated with an increased risk for VT, VF, or death (HR 1.66, 95% CI 1.09 to 2.52, p = 0.02). CONCLUSIONS: These results provide important mechanistic information, suggesting that worsening clinical condition and cardiac instability, as reflected by an IH-CHF or IH-CE, are subsequently associated with a significant increase in the risk for appropriate ICD therapy (for VT/VF) and death.

Aged↗
PubMed1995

Ventricular arrhythmias detected after transvenous defibrillator implantation in patients with a clinical history of only ventricular fibrillation. Implications for use of implantable defibrillator.

BACKGROUND: Patients with a history of ventricular fibrillation (VF) have been shown to have a clinical profile, response to electrophysiological testing (EPS), and response to antiarrhythmic therapy that distinguishes them from patients with a history of sustained monomorphic ventricular tachycardia (MVT). Despite these differences, it is not clear whether VF in these patients is triggered by MVT or occurs de novo. The incidence of MVT and VF in such patients after their index VF event has important implications for therapeutic decisions regarding implantable defibrillator selection and programming. METHODS AND RESULTS: The records of 111 consecutive patients who had undergone transvenous cardioverter/defibrillator (ICD) implantation for malignant ventricular arrhythmias were reviewed retrospectively. For each patient, all device tachyarrhythmia detections were examined and classified as VF, MVT, rapid polymorphic VT, or other. The number of events, time to first arrhythmia detection, and cycle length of MVTs were recorded. There were 55 patients with a history of only VF and 56 with a history that included an episode of MVT. Over 14 months of follow-up, with all patients initially off of antiarrhythmic medications, MVT was detected by only 18% of patients with a history of only VF compared with 54% of those with a history that included MVT (P = .002). Among patients who did detect MVT, those with a history of only VF had fewer episodes (7 +/- 7 versus 20 +/- 31, P = .001) and a shorter mean MVT cycle length (279 versus 314 ms, P = .03) than those with a clinical history of MVT. Abrupt onset of VF not preceded by MVT was detected in 11% of patients with VF only. In addition to a history of MVT, male sex, age < 60 years, and MVT inducible on EPS were all significantly associated with an increased likelihood of MVT detection. On multivariate analysis, the inducibility of MVT was the primary independent predictor of MVT detection but was of minimal incremental predictive value in the subgroup of patients with a history of only VF. When EPS results were not considered, arrhythmia history was the primary independent predictor of MVT detection. CONCLUSIONS: Patients with a history of only VF infrequently have MVT detected by their defibrillators. When these patients do detect MVT, it is faster than that detected in patients with a clinical history of MVT before ICD surgery. A significant percentage of VF survivors detected the abrupt onset of VF not preceded by MVT, suggesting that the deterioration of rapid MVT to VF is not the only clinically important mechanism of VF induction. These findings may have important implications for the understanding of the mechanism of VF induction and for use of an implantable defibrillator.

Cardiac Pacing, Artificial↗
PubMed1996

Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. Multicenter Automatic Defibrillator Implantation Trial Investigators.

BACKGROUND: Unsustained ventricular tachycardia in patients with previous myocardial infarction and left ventricular dysfunction is associated with a two-year mortality rate of about 30 percent. We studied whether prophylactic therapy with an implanted cardioverter-defibrillator, as compared with conventional medical therapy, would improve survival in this high-risk group of patients. METHODS: Over the course of five years, 196 patients in New York Heart Association functional class I, II, or III with prior myocardial infarction; a left ventricular ejection fraction < or = 0.35; a documented episode of asymptomatic unsustained ventricular tachycardia; and inducible, nonsuppressible ventricular tachyarrhythmia on electrophysiologic study were randomly assigned to receive an implanted defibrillator (n = 95) or conventional medical therapy (n=101). We used a two-sided sequential design with death from any cause as the end point. RESULTS: The base-line characteristics of the two treatment groups were similar. During an average follow-up of 27 months, there were 15 deaths in the defibrillator group (11 from cardiac causes) and 39 deaths in the conventional-therapy group (27 from cardiac causes) (hazard ratio for overall mortality, 0.46; 95 percent confidence interval, 0.26 to 0.82; P=0.009). There was no evidence that amiodarone, beta-blockers, or any other antiarrhythmic therapy had a significant influence on the observed hazard ratio. CONCLUSIONS: In patients with a prior myocardial infarction who are at high risk for ventricular tachyarrhythmia, prophylactic therapy with an implanted defibrillator leads to improved survival as compared with conventional medical therapy.

Adult↗
PubMed2006

Predicting early mortality after implantable defibrillator implantation: a clinical risk score for optimal patient selection.

BACKGROUND: Patients with advanced heart disease are at risk from sudden death; however, benefit from implantable cardioverter defibrillators (ICDs) may be limited as a result of early mortality from other causes. The objective of this study was to develop a model to predict mortality within the first year after ICD implantation. METHODS AND RESULTS: A retrospective analysis was performed of 469 consecutive patients who underwent ICD implantation at a single tertiary-care center from 1999 to 2002. Vital status was determined from the Social Security Death Index. Patients were randomized into prediction and validation cohorts. A risk score was derived from the prediction cohort by multivariate logistic regression and applied to the validation cohort. One point was assigned for each variable in the risk score (age > 80 years, history of atrial fibrillation, creatinine > 1.8 mg/dL, New York Heart Association class III or IV). One-year mortality significantly increased with increasing risk score in both the prediction and validation cohorts. Validation cohort mortality was 3.4% for 0 points, 4.3% for 1 point, 17% for 2 points, and 33% for > or = 3 points (P for trend < .0001). A risk score > or = 2 predicted a 1-year mortality rate of 21%, whereas a risk score < 2 predicted a mortality rate of 4% at 1 year (P < .0001). CONCLUSION: A risk score using simple clinical criteria may identify patients at high risk of early mortality after ICD implantation. This may be helpful in consideration of ICD risk/benefit for individual patients. Further studies conducted in a prospective manner using these clinical criteria are warranted.

Aged↗
PubMed1994

[Psychosocial needs of patients carrying an implantable defibrillator].

Implantable defibrillators have created a new cardiac population. But with that population come particular needs. Eighty-five per cent of patients with implantable defibrillators experience significant fears and worries. Many of them fear the first shock or worry about the device's reliability. Others wonder if they will be able to remain in their current occupation. Despite these worries and others, 60 per cent of patients state being satisfied with the device. On the other hand, 53 per cent of these patients' spouses still fear the defibrillators. The authors of this article underline that nurses must learn to intervene appropriately to meet their patients' physical, learning and psychosocial needs. The nurse's responsibilities are to help patients identify their social support system and mobilize their resources, and to help family members in meeting patients' needs.

Defibrillators, Implantable↗
PubMed1995

Awareness during anaesthesia for implantable cardioverter defibrillator implantation. Recall of defibrillation shocks.

Implantable cardioverter defibrillator implantation is performed under general anaesthesia. This report describes awareness or recall in two of 33 patients scheduled for implantation. After induction, anaesthesia was maintained using continuous infusions of propofol and atracurium and intermittent boluses of alfentanil. Propofol was given in the same arm as the implantation side. In these two patients propofol flowed out of the bleeding central venous access. To minimise the possibility of awareness, we advise that continuous infusions should be administered intravenously on the contralateral side to the implantation and that neuromuscular blocking agent be given by intermittent bolus injections.

Anesthesia, General↗
PubMed1995

Benefits and lessons learned from stored electrogram information in implantable defibrillators.

Implantable defibrillators have evolved from simple event counters to sophisticated diagnostic monitoring units capable of storing electrocardiographic information surrounding arrhythmia events and device therapy. In this review, the nature and characteristics of these stored electrocardiographic recordings are discussed and examples displayed. Potential benefits and limitation of stored electrogram analysis are described with respect to both clinical utility and the ability to enhance our understanding of ventricular arrhythmogenesis. Finally, future developments to improve data storage, retrieval, and analysis are identified.

Defibrillators, Implantable↗
PubMed2001

Do baseline characteristics accurately discriminate between patients likely versus unlikely to benefit from implantable defibrillator therapy? Evaluation of the Canadian implantable defibrillator study implantable cardioverter defibrillatory efficacy score in the antiarrhythmics versus implantable defibrillators trial.

OBJECTIVE: Our purpose was to evaluate whether baseline characteristics predictive of implantable cardioverter defibrillator (ICD) efficacy in the Canadian Implantable Defibrillator Study (CIDS) are predictive in the Antiarrhythmics Versus Implantable Defibrillators (AVID) Trial. BACKGROUND: ICD therapy is superior to antiarrhythmic drug use in patients with life-threatening arrhythmias. However, identification of subgroups most likely to benefit from ICD therapy may be useful. Data from CIDS suggest that 3 characteristics (age > or =70 years, ejection fraction [EF] < or =0.35, and New York Heart Association class >II) can be combined to reliably categorize patients as likely (> or =2 characteristics) versus unlikely to benefit (<2 characteristics) from ICD therapy. METHODS: The utility of the CIDS categorization of ICD efficacy was assessed by Kaplan-Meier analysis and Cox hazards modeling. The accuracy of the CIDS score was formally tested by evaluating for interaction between categorization of benefit and treatment in a Cox model. RESULTS: ICD therapy was associated with a significantly lower risk of death in the 320 patients categorized as likely to benefit (relative risk [RR] 0.57, 95% confidence interval [CI] 0.37-0.88, P =.01) and a trend toward a lower risk of death in the 689 patients categorized as unlikely to benefit (RR 0.70, 95% CI 0.48-1.03, P =.07). Categorization of benefit was imperfect, as evidenced by a lack of statistical interaction (P =.5). Although 32 of the 42 deaths prevented by ICD therapy in AVID were in patients categorized as likely to benefit, all 42 of these patients had EF values < or =0.35. Neither advanced age nor poorer functional class predicted ICD efficacy in AVID. CONCLUSION: Of the 3 characteristics identified to predict ICD efficacy in CIDS, only depressed EF predicted ICD efficacy in AVID. Thus physicians faced with limited resources might elect to consider ICD therapy over antiarrhythmic drug use in patients with severely depressed EF values.

Aged↗
PubMed1996

[Reuse of previously implanted defibrillators].

Implantable defibrillators are part of the therapeutical armamentarium for the treatment of tachycardia. About 2000 of these systems are implanted in Germany per year. Device costs range between 45,000 and 55,000 DM. The medium device life-time is 5 years. Questions about reuse of the systems after the patient's death arise. From ethical point of view these plans have to be opposed.

Cost-Benefit Analysis↗
PubMedDate not supplied

Can nurses in cardiology areas prepare patients for implantable cardioverter defibrillator implant and life at home?

This study explored nurses' confidence and competence in preparing patients for having an implantable cardioverter defibrillator implanted and for life at home after discharge. Whilst research has identified various physical and psychosocial effects to patients and their partners associated with device implant and subsequent lifestyle adjustments, no research has explored nurses' knowledge of the device or these effects. A survey was designed using a purposive sample of 152 nurses from cardiology areas in four large teaching hospitals and a 28-point postal questionnaire to explore knowledge of the device and its impact. Most subjects were not confident in their abilities to prepare patients for implant or life at home after implant. Knowledge of the device and its effects appeared poorly understood by all nurses, irrespective of additional qualifications, length of time since qualifying or area of work. Many participants were aware of the poor knowledge level of nurses and identified it as a weakness in current care practices. Lack of understanding may impair preparation of patients for implantation of or for living with an implantable cardioverter defibrillator, and feasible strategies to change this situation will require careful consideration and further investment.

Attitude of Health Personnel↗
PubMed1994

The impact of left ventricular dysfunction on outcomes with the implantable defibrillator.

Implanted cardioverter defibrillators (ICDs) are very effective in the treatment of life-threatening ventricular arrhythmias. Among patients with severe left ventricular (LV) dysfunction, ICDs can defibrillate at energies similar to those in patients with well-preserved LV function; the perioperative mortality rate with transvenous systems is low, even in patients with a low ejection fraction (EF). In patients whose EF is < 30%, sudden death and total mortality rates are relatively low. However, at most only 50% of deaths in patients with low EFs are sudden, and life in these patients may be only slightly prolonged by successful defibrillator shocks. The true value of ICDs in these patients can be determined only by comparison with optimal medical therapy in randomized controlled studies. The Canadian Implantable Defibrillator Study randomly assigns patients with ventricular fibrillation or ventricular tachycardia to ICD or amiodarone. Current patient profiles show that most of these patients have poor LV function (mean EF, 33.6%), and most receive optimal medical therapy. Results of this and other studies will clarify the benefits from ICDs in these patients with severe heart disease.

Anti-Arrhythmia Agents↗
PubMed1995

Atrial fibrillation after implantable cardioverter defibrillator implantation.

Atrial fibrillation is a reported complication of automatic defibrillator implantation. Its incidence, risk factors, time-course, and complications have not been well-defined. Accordingly, data from 117 patients who underwent defibrillator implantation via a thoracotomy (n = 71) or nonthoracotomy (n = 46) approach were reviewed. To identify risk factors, 15 variables of potential predictive value were chosen and analyzed. Atrial fibrillation developed in 26/117 patients (22%) during the early postoperative period and all but one of these 26 patients had undergone thoracotomy (P < 0.001). Patients who developed atrial fibrillation tended to be older than those who did not (63 +/- 2 vs 58 +/- 2 years, P = 0.04) and more frequently had a prior history of paroxysmal atrial fibrillation (31% vs 10%, P = 0.02). They were also less likely to be taking Class I or III antiarrhythmic drugs (1/26 vs 24/91, P = 0.01). By multivariate analysis, operative approach (P < 0.001), the absence of antiarrhythmic drug therapy (P = 0.006), and a prior history of atrial fibrillation (P = 0.003) were significant independent variables. Digoxin neither prevented the occurrence of atrial fibrillation nor slowed the maximal ventricular response. The mortality and complication rates did not differ between the two groups. The major adverse effect of postimplant atrial fibrillation was automatic defibrillator discharge; six patients received between 1 and 11 discharges for atrial fibrillation with rapid ventricular rates.

Adolescent↗
PubMed1996

[Anesthetic management for AICD (automatic implantable cardioverter defibrillator) implant surgery].

We studied anesthetic management and monitoring during AICD (automatic implantable cardioverter defibrillator) implantation. For anesthetic management, complete sedation and amnesia are needed during implantation procedures with rapid awakening and extubation after the surgery. We chose inhalation anesthesia supplemented with small doses of fentanyl or thiamylal. Monitoring for AICD implantation should be less invasive, continuous and rapid in responsiveness. For brain and cardiac monitoring, a combination of near infrared spectroscopy and transesophageal echocardiography was quite useful.

Anesthesia, General↗
PubMed2005

Differences in outcomes between patients treated with single- versus dual-chamber implantable cardioverter defibrillators: a substudy of the Multicenter Automatic Defibrillator Implantation Trial II.

OBJECTIVES: We sought to evaluate the influence of single- versus dual-chamber implantable cardioverter defibrillators (ICDs) on the occurrence of heart failure and mortality as well as appropriate and inappropriate ICD therapy in the Multicenter Automatic Defibrillator Implantation Trial II (MADIT-II). BACKGROUND: In MADIT-II, ICD therapy in patients with a prior myocardial infarction and ejection fraction < or =0.30 was associated with a 31% reduction in risk of mortality when compared to conventionally treated patients. An unexpected finding was an increased occurrence of hospitalization for heart failure in the ICD group. METHODS: Data from 717 patients randomized to ICD therapy with single- or dual-chamber pacing devices in MADIT-II were retrospectively analyzed. Endpoints selected for analysis included death from any cause, new or worsening heart failure requiring hospitalization, death or heart failure, appropriate therapy for ventricular tachycardia (VT) or ventricular fibrillation (VF), and inappropriate ICD therapy for atrial fibrillation or supraventricular tachycardia. RESULTS: A total of 404 single-chamber ICDs (S-ICDs) and 313 dual-chamber ICDs (D-ICDs) were implanted. Patients receiving D-ICDs were at a higher risk at baseline than those receiving S-ICDs, with older age, higher NYHA class, more frequent prior CABG, wider QRS complex, more LBBB, higher BUN level, a history of more atrial arrhythmias requiring treatment, and a longer time interval from their index myocardial infarction to enrollment. While there was a trend toward an increase in adverse outcomes in the D-ICD group, no statistically significant differences in heart failure or mortality were observed between S-ICD versus D-ICD groups. CONCLUSIONS: Patients with D-ICDs had a nonsignificant trend toward higher mortality and heart failure rates than patients with S-ICDs.

Arrhythmias, Cardiac↗
PubMed2005

Effects of beta-blockers on implantable cardioverter defibrillator therapy and survival in the patients with ischemic cardiomyopathy (from the Multicenter Automatic Defibrillator Implantation Trial-II).

This study examined the effects of beta blockers on (1) appropriate implantable cardioverter defibrillator (ICD) therapy for ventricular tachycardia (VT) or ventricular fibrillation (VF), (2) inappropriate ICD therapy for atrial fibrillation or supraventricular tachycardia, and (3) survival in 691 patients who received ICDs in the Multicenter Automatic Defibrillator Implantation Trial-II. The study population involved 258 patients who were not receiving beta blockers and 433 who were receiving metoprolol (n = 192), atenolol (n = 58), or carvedilol (n = 182). Patients receiving beta blockers were divided into the upper quartile and lower 3 quartiles of the drug doses they were taking. Patients receiving the higher doses of beta blockers (those in the top quartile of doses) had a significant reduction in the risk for VT or VF requiring ICD therapy compared with patients not receiving beta blockers (hazard ratio 0.48, p = 0.02). The frequency of inappropriate ICD therapy for supraventricular tachyarrhythmias was not significantly different among the 3 treatment groups (p = 0.32). Beta-blocker use at the 2 dosage levels was associated with significant improvement in survival compared with the nonuse of beta blockers (hazard ratios 0.42 to 0.44, p <0.01). In conclusion, beta blockers reduce the risk for VT or VF and improve survival in ICD-treated patients with ischemic cardiomyopathy.

Adrenergic beta-Antagonists↗
PubMed1995

Indications of implantable defibrillator.

Implantable cardioverter defibrillators are devices capable of detecting and terminating ventricular tachycardias or fibrillations. They are utilized in the treatment of severe ventricular tachyarrhythmias, and their efficacy in the prevention of sudden death is demonstrated. As a matter of fact, despite the new antiarrhythmics available, and despite nonpharmacological therapies like radiofrequency ablation or surgery, the prognosis of such tachyarrhythmias remains serious.

Defibrillators, Implantable↗