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Preventing sudden death in coronary cardiomyopathy: implantable defibrillators lead the way.

The Multicenter Unsustained Tachycardia Trial (MUSTT) demonstrated that electrophysiologic testing (EP)-guided therapy significantly reduces arrhythmic death and cardiac arrest in patients with coronary artery disease, a left ventricular ejection fraction of 40% or less, nonsustained ventricular tachycardia, and inducible ventricular arrhythmia on EP testing-but only if the therapy includes an implantable defibrillator. All patients who meet the MUSTT inclusion criteria should undergo an EP test and if positive, should undergo defibrillator implantation.

Arrhythmias, Cardiac↗

Determinants of outcome in patients with sustained ventricular tachyarrhythmias: the antiarrhythmics versus implantable defibrillators (AVID) study registry.

BACKGROUND: The prognosis of patients with sustained ventricular tachyarrhythmias varies according to clinical characteristics. We sought to identify predictors of survival in a large population of patients with documented sustained ventricular tachyarrhythmias not related to reversible or correctable causes included in the Antiarrhythmics Versus Implantable Defibrillators (AVID) Registry. METHODS AND RESULTS: We analyzed the impact of 36 demographic, clinical, and discharge treatment variables on the outcome for 3559 patients. Survival status was assessed with the use of the National Death Index. Multivariate analyses were performed with the use of the Cox proportional hazards model. After a mean follow-up of 17 +/- 12 months, 631 patients died. Actuarial survival was 0.86 (95% confidence interval [CI] 0.85 to 0.88), 0.79 (95% CI 0.78 to 0.81), and 0.72 (95% CI 0.70 to 0.74) at 1, 2, and 3 years. Multivariate predictors of worse survival included older age, severe left ventricular dysfunction, lower systolic blood pressure, history of congestive heart failure, diabetes, smoking or atrial fibrillation, and preexistent pacemaker. The hemodynamic impact of the qualifying arrhythmia was not a predictor of outcome. Defibrillator implantation and hospital discharge while the patient was taking a beta-blocker or an angiotensin-converting enzyme inhibitor were associated with better prognosis. CONCLUSIONS: Despite therapeutic advances, the mortality rates of patients with sustained ventricular tachyarrhythmias remain high. Prognosis depends on the severity of underlying heart disease, as reflected by the extent of left ventricular dysfunction and the presence of heart failure. Well-tolerated ventricular tachycardia in patients with structural heart disease does not carry a significantly better prognosis than ventricular tachyarrhythmia with more severe hemodynamic consequences.

Aged↗

Differences in the pathological changes in dogs' hearts after defibrillation with extrapericardial paddles and implanted defibrillator electrodes.

A comparison was made between the pathological changes in the myocardium of eight dogs, each receiving about 90 joules of energy in a series of defibrillation discharges, delivered either between paddles placed against the pericardium (3 dogs) or between implanted Telectronics 040-105 defibrillation patch electrodes (5 dogs). The changes in the myocardium were most pronounced where the paddles had been applied to the pericardium. There was transmural damage beneath the left and right paddle positions and in the surrounding tissues. Extensive subepicardial and subendocardial myocyte damage was obvious histologically in the right ventricle of one of the patch dogs and in all of the paddle dogs. The percentage of damaged myocardial mass, both right ventricular and total involvement, was higher in the three paddle dogs compared with the five patch dogs. There was septal damage in the heart of one paddle dog. Necrosis of the right ventricular wall was observed in three of the patch dogs and in all the three paddle dogs. Scattered necrotic myocytes and some patches of mild necrosis up to 1-mm deep were observed in the left ventricle of the patch dogs (severity score 1-3). The necrosis was more extensive in the paddle dogs, ranging from mild necrosis less than 1-mm deep to marked necrosis incorporating half-to-whole ventricular wall thickness (severity score 3-5).

Animals↗

Syncope following cardioverter defibrillator implantation in patients with spontaneous syncopal monomorphic ventricular tachycardia.

AIMS: We sought to determine the incidence, mechanisms, and time to syncope recurrence in patients with spontaneous syncopal monomorphic ventricular tachycardia (SyMVT) treated with an implantable cardiac defibrillator (ICD). METHODS AND RESULTS: Incidence and causes of syncope following ICD implantation in consecutive patients (n=26) with spontaneous SyMVT were compared with those found in consecutive patients (n=50) with spontaneous non-syncopal monomorphic ventricular tachycardia (NSyMVT). Patients with SyMVT had a higher incidence of syncope (46% patients) than those with NSyMVT (2% patients) at 31+/-21 and 34+/-23 months follow-up, respectively (hazard ratio, 0.19; 95% confidence interval, 0.04-0.42; P=0.0001). Among the former, four patients (15%) had non-arrhythmic syncope and eight patients had arrhythmic syncope (31%), which was associated with either ICD proarrhythmia (seven episodes of VT acceleration or VF degeneration by ATP or low/high-energy shocks in three patients) or spontaneous VT and VF (five episodes in five patients). Median time to the first arrhythmic syncope was 376 days. Arrhythmic syncope presented after a first non-syncopal VT recurrence in six patients (75%). CONCLUSION: Syncope following ICD implantation is common in patients with SyMVT in contrast to patients with NSyMVT. Late syncope presentation supports reassessment of driving restrictions in this setting.

Cohort Studies↗

Permanent pacemakers and implantable defibrillators: considerations for intensivists.

Pacemakers and cardioverter-defibrillators are implanted in patients with cardiovascular disease for an ever-increasing array of indications. Intensivists provide care frequently for patients who have these devices, and thus, they must be familiar with common problems and nuances that may contribute to critical illness. Close collaboration of the critical care physician and cardiologist/electrophysiologist assures that pacemakers and defibrillators are tuned to optimize the hemodynamic milieu of critically ill patients. Many recent advances in the sophistication of implanted devices are reviewed herein.

Arrhythmias, Cardiac↗

Increase in defibrillation threshold in non-thoracotomy implantable defibrillators using a biphasic waveform.

We have previously reported a chronic increase in defibrillation threshold in a non-thoracotomy implantable cardioverter-defibrillator (ICD) system using monophasic waveforms. To determine if this phenomenon is related to the lead system or the waveform used, we studied the chronic defibrillation threshold in consecutive patients receiving an ICD capable of delivering biphasic waveforms with the same lead system previously evaluated. Twenty-five patients received an ICD with biphasic shock waveform and have been followed for 4 to 15 months. All have undergone defibrillation threshold measurements using the identical testing protocol with biphasic waveforms at implant and at 2 months. Coronary artery disease was present in 15, idiopathic dilated cardiomyopathy in 9, and valvular heart disease in 1. The presenting arrhythmia was ventricular fibrillation in 11, ventricular tachycardia in 10, and syncope with inducible ventricular tachycardia in 4. The configuration of the shocking electrodes was randomized; the lead-only configuration was used in 14 patients (56%), and a subcutaneous patch was used in the remaining patients. Mean defibrillation threshold using a step-down technique was 9.8 +/- 1.0 J at implant, 13.2 +/- 1.6 J at 2 months, and 12.4 +/- 1.5 J at 6 months (p = 0.01 by analysis of variance). There was no change in clinical status, cardiac size, radiographic lead position, or impedance between implant and 2 months. These findings suggest the increase in defibrillation threshold in this ICD system is not related to the type of waveform used, but rather is a feature of non-thoracotomy as opposed to epicardial electrodes.

Adult↗

Evoked potential monitoring during repeatedly induced ventricular fibrillation for internal defibrillator implantation.

Repeated induction of ventricular fibrillation (VF) with circulatory compromise during implantable cardioverter defibrillator (ICD) testing may cause cerebral injury. To test this hypothesis, somatosensory evoked potentials (SEP), a more sensitive marker of injury, were recorded in patients (N = 10) undergoing ICD implantation. SEP were recorded before induction of anesthesia, after induction of anesthesia, before and at several times following induction of VF. Possible modifying factors of the SEP measurements such as anesthetic application, blood pressure, body temperature, and hematocrit remained constant throughout the operations. Central conduction time was unaffected by ICD defibrillation testing. Amplitude of SEP primary complexes was transiently reduced at 34.9% (P < 0.01) by defibrillation testing, but returned to control within 10 minutes after testing. It is concluded that while ICD defibrillation testing may produce transient changes in SEP, there is no evidence of residual cerebral injury.

Adult↗

[Peritoneal migration of defibrillator implanted behind the rectus abdominis].

Automatic Implantable Cardioverter Defibrillator (AICD) has become a therapeutic option to malignant ventricular tachyarrhythmias. Its bulky device responds for discomfort and the likelihood of generator extrusion or migration, when implanted under the subcutaneous tissue. Among alternative sites, pre-peritoneal location has several advantages but hides its own risks. We present a generator peritoneal migration from a pocket made behind the rectus abdominis.

Aged↗

Psychopathology following cardioverter defibrillator implantation.

Previous reports have found elevated rates of psychopathology in recipients of implantable cardioverter defibrillators (ICDs). Thirty-five consecutive ICD recipients were assessed by using the Structured Clinical Interview for DSM-III-R and a semistructured questionnaire; assessments were performed within 3 days of ICD implantation (Time 1) and again 9-18 months later (Time 2). At the initial assessment, alcohol dependence in remission was the most common diagnosis, followed by mood disorders. Two cases of depression were found at follow-up assessment, but those subjects had either a lifetime history of major depression or some depressive symptoms at Time 1. No new cases of anxiety disorders were seen at Time 2. It appears that ICD recipients have rates similar to the general population at the time of implantation, and the risk for new psychopathology is largely confined to those with a lifetime history of psychopathology.

Adaptation, Psychological↗

Indications for internal cardioverter defibrillator implantation predict time to first shock and the modulating effect of beta-blockers.

BACKGROUND: Patients receive implantable cardioverter defibrillator (ICD) for varying indications. Whether these indications influence the time to first ICD shock is suspected but not confirmed. The modulating effect of beta-blockers on shock-free survival is not fully elucidated. METHOD: A retrospective analysis of 230 consecutive patients (age 63 +/- 14 years, 79% men, 75% ischemic, 70% beta-blockers) implanted with an ICD was performed. Patients were divided into 4 groups depending on the ICD indication: groups A (secondary prevention of sudden death), B (left ventricular ejection fraction < or = 35% and positive electrophysiology study [EPS]), C (left ventricular ejection fraction < or = 35% and negative EPS or no EPS performed), and D (patients who did not meet inclusion criteria for groups A, B, or C). Time to shock was analyzed by the Kaplan-Meier method. RESULTS: During a mean follow-up of 489 +/- 280 days, 57 (24.7%) patients received 82 shocks (49% appropriate). The 1-year shock-free survival for patients in groups A, B, C, and D were 57%, 77%, 79%, and 91%, respectively (P = .03), for total shocks and 75%, 92%, 92%, and 100%, respectively (P = .007), for appropriate shocks. For patients in group A, the use of beta-blockers increased the 1-year shock-free survival from 48% to 61% for total shocks and from 65% to 79% for appropriate shocks. CONCLUSION: Time to first shock is determined by the indication for ICD implantation and is not predicted by the results of EPS. Patients with secondary indications for ICD implantation are at highest risk of shocks and may deserve consideration for prophylactic antiarrhythmic drugs. beta-Blockers increase the time to first ICD shock in patients implanted for secondary prevention of sudden death.

Adrenergic beta-Antagonists↗

Selected patients listed for cardiac transplantation may benefit from defibrillator implantation regardless of an established indication.

BACKGROUND: End-stage heart failure (HF) patients are at high risk of sudden cardiac death. This study evaluates the role of implantable cardiac defibrillators (ICDs) in HF patients awaiting cardiac transplantation. METHODS: We identified 194 consecutive patients (age 51 +/- 12 years) with New York Heart Association Class 3 or 4 HF (ejection fraction 22 +/- 9%) listed for cardiac transplantation, 35 of whom underwent ICD implantation. Of the implanted patients, 16 (Group A) had an established indication for ICD implantation (cardiac arrest, n = 10; sustained ventricular tachycardia [VT], n = 3; and positive electrophysiology study, n = 3). Nineteen patients (Group B) underwent ICD implantation for non-established indications (syncope with non-ischemic cardiomyopathy, n = 4; non-sustained VT, n = 15). There were no procedural complications from ICD implantation. RESULTS: During follow-up of 9.2 +/- 10.1 months, there were 3 deaths in the ICD groups (A and B), and 40 in the control group (8.6% vs 25.2%, p = 0.032). Five patients in Group A and 6 in Group B (31%) received appropriate ICD therapy. The number of therapies per patient and the time to the first shock were similar between Groups A and B. Four of 6 Group B patients on outpatient inotropic therapy (67%) received appropriate ICD therapy. CONCLUSIONS: Selected end-stage heart failure patients awaiting heart transplantation, including those without established ICD indications, are at high risk for malignant arrhythmias and may benefit from ICD implantation. Patients with ICD seem to have improved survival compared to those without ICD. Randomized prospective studies are needed to confirm these findings.

Adult↗

Defibrillation energy requirements using a left anterior chest cutaneous to subcutaneous shocking vector: implications for a total subcutaneous implantable defibrillator.

BACKGROUND: Subcutaneous implantable defibrillators (ICDs) are being developed to facilitate ICD implantation. OBJECTIVE: The purpose of this study was to estimate the human defibrillation energy requirement (DER) using a left chest cutaneous (Q) to subcutaneous (SQ) shocking vector. METHODS: Twenty patients undergoing implantation of an indicated ICD were enrolled (15 males, age = 63 +/- 12 years; ejection fraction = 0.27 +/- 0.14). Defibrillation testing was performed using an investigational system consisting of an external defibrillator and a constructed connector to deliver a shock between a pectoral SQ can and a cardiac apical Q electrode. Two attempts at defibrillation using this configuration were allowed. Stage 1 testing started at 70 J with a step-down/step-up to 50 or 100 J, respectively. Stage 2 testing began at 50 J with a step-down/step-up to 30 or 70 J. RESULTS: During stage 1, a 70-J shock was successful in 7/9 (78%) patients. A second attempt was successful in 7/7 patients using a 50-J shock. In the two remaining patients, a second attempt using a 100-J shock was successful. During stage 2, a 50-J shock was successful in 10/11 (91%) patients. The protocol could not be completed in 2/11 patients. Of the remaining nine patients, a second defibrillation was successful in seven (78%) using a 30-J shock. CONCLUSIONS: The defibrillation energy requirement (DER) of this study vector was 50 J or less in most patients. This low DER supports further investigation of a totally SQ-ICD. However, the DER of 100 J in two patients indicates that further investigation is needed regarding DER variability and safety margins.

Aged↗

Effect of general anesthesia on the defibrillation energy requirement in patients undergoing defibrillator implantation.

BACKGROUND: The effect of general anesthesia on defibrillation efficacy in humans is not known. The purpose of this study was to determine the effect of general anesthesia on the defibrillation energy requirements in patients undergoing implantation of a pectoral defibrillator. METHODS AND RESULTS: Nineteen consecutive patients who underwent defibrillator implantation under general anesthesia were prospectively compared to 16 consecutive patients who underwent defibrillator implantation by the same physicians, using similar devices, at another hospital under conscious sedation. Pre-discharge testing was performed 1.4 +/- 1.0 days after implant using sedation in both groups. The defibrillation energy requirement was determined using the same predefined step-down protocol (15, 10, 8, 5, 3, 1 J) at the time of implantation and during pre-discharge testing. The clinical characteristics of the patients were similar between groups. There was no significant difference in the mean implant defibrillation energy requirement compared to the mean pre-discharge defibrillation energy requirement in either the general anesthesia group (8.5 +/- 4.7 vs. 8.4 +/- 3.4 J; p = 0.9) or in the conscious sedation group (9.4 +/- 3.9 vs. 9.0 +/- 3.8 J; p = 0.7). CONCLUSIONS: When compared to conscious sedation, general anesthesia with mechanical ventilation has no significant effect on defibrillation efficacy in patients undergoing defibrillator implantation.

Aged↗

Impact of the multicenter automatic defibrillator implantation trial on clinical practice.

BACKGROUND: The first multicenter automatic defibrillator implantation trial (MADIT-I) was a landmark study that identified a significant reduction in mortality among high-risk patients with ischemic cardiomyopathy treated prophylactically with an implantable cardioverter defibrillator (ICD), yet the direct and indirect impact of this trial on clinical practice is unknown. METHODS: We performed a retrospective analysis of the 679 patients who underwent primary ICD implantation between 1994 and 2000 at a single academic center. The baseline characteristics of each patient were determined at the time of ICD implantation, and the vital status of all patients was determined as of January 1, 2004. RESULTS: The number of patients who received an ICD based on the MADIT-I criteria increased from 1.4% in 1994 to 6.1% in 2000. An additional 60 patients were identified that met many but not all of the trial criteria and consisted of patients with a history of a recent revascularization or myocardial infarction, syncope, or an ejection fraction >or=35%. The number of patients who received ICDs in this expanded MADIT-I subset also grew from 5.6% in 1994 to 14.6% in 2000. Mortality during a mean follow-up of 4.7 years was significantly higher in the MADIT-I group than in the expanded MADIT-I, or the remaining primary prevention and secondary prevention subsets. CONCLUSION: The MADIT-I has not only led to an increase in the number of patients undergoing prophylactic ICD implantation, but in clinical practice it has also been extrapolated to a broader population that has a different degree of risk than originally studied.

Aged↗

Detection of refrigerator-associated 60 Hz alternating current as ventricular fibrillation by an implantable defibrillator.

This report describes a patient with an implantable defibrillator who suffered an inappropriate defibrillation shock upon retrieving some food items from his inadequately earthed refrigerator. Noise typical of electrical interference can be observed in the stored electrogram of the episode. The patient was instructed to earth his home appliances, but he decided to avoid his refrigerator altogether, and has had no subsequent shocks.

Aged↗

[Short-term and long-term outcome of left heart function after cardioverter defibrillator implantation].

The usefulness and problems of implantable cardioverter defibrillators (ICD) were examined in patients with reduced heart function. Of 36 patients who received ICD for refractory ventricular tachycardia (VT) or ventricular fibrillation (VF), VT and/or VF was associated with underlying heart disease in 26 patients, and VF without underlying heart disease in 10. Of the former 26 patients, 13 with left ventricular ejection fraction (LVEF) of less than 30% were assigned to group A, 13 with LVEF of greater than 30% to group B, and the other 10 with idiopathic VF to group C. Intraoperative death, cardiac death due to heart failure, sudden death, functional status of the ICD, exacerbation of heart failure symptoms and complications were compared between the three groups. There were no intraoperative deaths in any of the groups. During the median follow-up period of 36 +/- 22 months, there was only one sudden death in group A. There were no significant differences between the three groups. There were five cardiac deaths in group A, but none in groups B or C. The cardiac death-free rates 12, 24, and 36 months after implantation in group A were 83%, 60% and 50%, respectively. These values significantly differed from those in groups B and C (p < 0.05). The number of patients who received defibrillation therapy was higher in group A (p < 0.05). Defibrillation therapy was administered earlier in group A than in groups B and C (p < 0.05). The incidence of exacerbation of heart failure after implantation was 69%, 23% and 0% in groups A, B, and C, respectively. In group A, defibrillation therapy was administered in all patients with exacerbation of heart failure. The administration of defibrillation therapy significantly differed from that in patients without exacerbation of heart failure (p < 0.05). Exacerbation of heart failure during the postoperative acute stage occurred in both patients in group A in whom an epicardial lead system was used, but not in the four patients in group B or five in group C (p < 0.05). There were no differences in the incidence of other complications between the three groups. In group A, patients with reduced heart function, ICD greatly decreased the risk of sudden death. However, heart failure mortality remained high. Therefore, ICD may have limitations for improved prognosis. In group A patients, defibrillation therapy was administered in all patients with exacerbation of heart failure or death due to heart failure. In patients with reduced heart function, treatment for heart failure and prophylaxis of VT and/or VF should be administered.

Adult↗

Comparison of long-term outcomes of patients treated with nonthoracotomy and thoracotomy implantable defibrillators.

In 193 consecutive patients treated with implantable defibrillators at our institution, thoracotomy approaches were used in 87 patients and nonthoracotomy approaches in 106 patients. Long-term outcomes of the 2 groups were compared by the intention-to-treat analysis. Surgical mortality (30-day mortality) rates were 5.7% in the thoracotomy group and 0% in the nonthoracotomy group. Six of 106 patients who underwent nonthoracotomy implantation had a high defibrillation threshold and did not receive nonthoracotomy defibrillators. The duration of follow-up was 52 +/- 31 months in the thoracotomy group, and 23 +/- 15 months in nonthoracotomy group. Actuarial survival rates at 6 and 24 months were, respectively, 90% and 81% in nonthoracotomy patients and 89% and 80% in thoracotomy patients (p = NS). In patients with left ventricular ejection fraction <30%, surgical mortality was 0% by the nonthoracotomy and 10% by the thoracotomy approach. Despite the 10% difference in 30-day mortality, survival rates at 6 months were 85% in nonthoracotomy patients and 81% in thoracotomy patients. At 24 months they were 73% in nonthoracotomy patients and 74% in thoracotomy patients. Thus, this nonrandomized study suggests that while short-term survival is better in nonthoracotomy patients than thoracotomy patients, the difference in survival diminishes quickly during the first few months and disappears by 6 months. The results were similar in patients with severe ventricular dysfunction. Several important implantable-cardioverter defibrillator (ICD) trials initially utilized thoracotomy ICDs. Although questions may be raised with regard to applicability of such a trial in the era of nonthoracotomy ICDs, this study suggests that the results of such ICD trials will be largely applicable to patients treated with nonthoracotomy ICDs.

Aged↗

Acute efficacy and chronic follow-up of patients with non-thoracotomy third generation implantable defibrillators.

Non-thoracotomy implantation of implantable cardioverter defibrillators (ICDs) has simplified the process of device insertion, promising to decrease associated procedural complications while providing sudden death protection at least equal to epicardial systems. This study presents the acute and chronic results of 110 patients who underwent attempted non-thoracotomy ICD implantation with the Medtronic Transvene lead system and PCD model 7217 or 7219. Of the 110 patients attempted, 100 (91%) had the system successfully implanted without the need for an epicardial patch. One patient died 1 week postoperatively of septic shock related to the implantation (0.9% perioperative mortality). During follow-up of 16 +/- 11 months, 45% of the patients had an event detected as ventricular tachycardia; 26% of these detections were felt clinically to be due to supraventricular rhythms. Of the remainder, 87% were successfully treated with the first VT therapy, and 98% were terminated by the final therapy; 66% of the patients had at least one episode of ventricular fibrillation, of which 5% were felt to be inappropriate detections; 85% of the appropriate episodes were successfully treated with the first VF therapy, and all were converted by the final therapy. Total mortality at 6, 12, and 24 months was 3%, 11%, and 19% respectively. Only one patient had sudden cardiac death, occurring at 13 months postimplant. Overall, the non-thoracotomy lead system for this ICD displayed infrequent implant complications and proved to be reliable at terminating arrhythmias and maintaining a low rate of sudden cardiac death in this high risk population.

Adult↗