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PubMed1989

Transdiaphragmatic implantation of the automatic implantable cardioverter defibrillator.

A new surgical approach for implantation of the automatic implantable cardioverter defibrillator without thoracotomy was used in 12 patients, aged 46 to 72 years. Preimplantation arrhythmia was ventricular tachycardia in 7 patients and ventricular fibrillation in 5 patients. The mean ejection fraction was 19%. Six patients were at high risk for general anesthesia for a variety of medical problems, and 2 patients had had a previous cardiac operation. Epidural anesthesia was used in 8 patients without intubation. The surgical approach used a longitudinal epigastric extraperitoneal incision with access to the heart through an incision made in the central tendon of the diaphragm. Two patches and two epicardial sensing leads were placed in all patients. All patients but one could be defibrillated with 20 J or less. There was no operative mortality and minimal morbidity. There were two late deaths due to heart failure. Thus, the transdiaphragmatic approach provides an excellent exposure for automatic implantable cardioverter defibrillator implantation, avoids general anesthesia and thoracotomy, and can be used after a previous cardiac operation.

Aged↗
PubMed1994

Changes in cerebral perfusion during third-generation implantable cardioverter defibrillator testing.

Third-generation implantable cardioverter defibrillators (ICDs) are designed to provide tiered therapy for ventricular tachycardia and ventricular fibrillation. At present, however, therapy prescription does not take into account the hemodynamic consequences of ventricular dysrhythmias. Design of "intelligent" devices depends on their ability to assess hemodynamic consequences of tachyarrhythmias and end-organ perfusion. Quantitative electroencephalography (QEEG) and transcranial Doppler flow provide sensitive and specific measures of cerebral perfusion during ICD testing and programming. In response to prolonged hypotension (> 15 seconds), transient loss of alpha power (i.e., increase in delta power) in the EEG spectrum, accompanied by impaired cerebrovasomotor reactivity (CVR), was observed in 25 of 91 hypotensive episodes in 15 patients, ages 36 to 72 years, predicting intolerance to the programmed ICD therapy. Conversely, intact CVR prevented ischemia, slowing in the EEG, and predicted tolerance to the therapy prescription. These changes were exaggerated in the erect posture during tilt-table ICD testing. During ventricular tachycardia, signs of cerebral hypoxia detected by QEEG and Doppler techniques were accompanied by a fall in transcranial oxyhemoglobin saturation measured by near-infrared spectroscopy. We conclude that transcranial Doppler and QEEG are sensitive indicators of cerebral perfusion. These techniques could be used as indexes of perfusion against which hemodynamic sensors for future ICDs could be evaluated.

Adult↗
PubMed1994

Continuous monitoring of acute myocardial ischemia by the implantable cardioverter defibrillator.

The present generation of implantable cardioverter defibrillators (ICDs) provides a very effective device for monitoring and treating life-threatening ventricular tachyarrhythmia. Patients at risk of sudden cardiac death who are directed to this form of treatment usually have severe coronary artery disease, previous myocardial infarction, and low ejection fraction. Progression of the underlying heart disease predisposes these patients to subsequent ischemic events, including symptomatic and asymptomatic myocardial ischemia and reinfarction, which carry a substantial risk of fatal ventricular proarrhythmia. Multipolar lead configurations presently available in the ICD appear to be effective in assessing acute myocardial ischemia as induced by exercise testing or transient coronary artery occlusion. Continuous monitoring of myocardial ischemia (COMONI) by a sophisticated, multimodal ICD appears to be feasible, may offer the means to closely supervise progression and various complications of the underlying heart disease, and may help to guide automatic or interactive antiischemic treatment.

Algorithms↗
PubMed2001

A priori expectancy bias and its relation to shock experience and anxiety: a naturalistic study in patients with an automatic implantable cardioverter defibrillator.

Patients with an automatic implantable cardioverter defibrillator (AICD) may offer an unique naturalistic opportunity to study whether expectancy biases develop because of precipitating aversive or traumatic experiences and/or because of elevated anxiety. An expectancy bias and its associations with AICD discharge and anxiety was examined in 24 AICD patients with a thought experiment. While patients without AICD discharge exhibited no expectancy bias, patients with discharge experiences were found to expect that stimuli depicting medical emergency situations will be followed by an aversive consequence. The magnitude of their expectancy bias was positively correlated with their anxiety level. In the group with AICD discharge, patients with low anxiety levels exhibited no bias, while patients with high anxiety levels exhibited a rather strong bias. It seems that the experience of an aversive or traumatic event, here an AICD discharge, is a necessary (but not sufficient) precipitating event for the development of an expectancy bias. If such an event happens, trait anxiety level presumably determines if and how strong the expectancy bias will be.

Adult↗
PubMed2002

Automatic discrimination between supraventricular and ventricular tachycardia using a multilayer perceptron in implantable cardioverter defibrillators.

The morphological analysis of implantable cardioverter defibrillator (ICD) stored electrograms (EGM) using a multilayer perceptron (MLP) has been proposed for discrimination between supraventricular and ventricular arrhythmias. However, a reliable estimation of the accuracy of MLP methods is lacking. The aim of the study was to compare the morphology and spectrum-based MLP with more conventional morphology-based algorithms in a large series of ICD-stored episodes of arrhythmia. One set of ICD-stored electrograms was used for control and training purposes and a second one, consisting of spontaneous episodes in patients with dual chamber ICDs, for validation of the MLP performance. The correlation waveform analysis (CWA) and the EGM width criterion were compared with MLP methods. Bootstrap resampling techniques were used to extract the relevant information in the MLP training. The morphology-based MLP achieved better discrimination than any other method, with areas under the receiver operating characteristic (ROC) curve (tolerance intervals): 0.96 (0.81, 0.96) for MLP, 0.91 (0.77, 0.94) for CWA, and 0.68 (0.49, 0.78) for EGM width in the validation set. A specificity of 73.0% was obtained at 95% sensitivity, compared with 38.1% and 55.1% using CWA and EGM width criteria, respectively. In contrast, the generalization capabilities of spectral-based MLP methods are poor, showing a lower area under the ROC curve in the validation set. Time-domain MLP techniques may be useful for the morphological analysis of the intracardiac EGM signal stored by ICD devices. When properly trained and validated, these methods perform better than other commonly used morphological criteria for discrimination between supraventricular and ventricular arrhythmias.

Algorithms↗
PubMed2002

Changing trends in pacemaker and implantable cardioverter defibrillator generator advisories.

Pacemaker and implantable cardioverter defibrillator (ICD) generator recalls and safety alerts (advisories) occur frequently, affect many patients, and are increasing in number and rate. It is unknown if advances in device technology have been accompanied by changing patterns of device advisory type. Weekly FDA Enforcement Reports from January 1991 to December 2000 were analyzed to identify all advisories involving pacemaker and ICD generators. This article represents additional analysis of previously cited advisories and does not contain additional recalls or safety alerts over those that have been previously reported. The 29 advisories (affecting 159,061 devices) from the early 1990s (1991-1995) were compared to the 23 advisories (affecting 364,084 devices) from the late 1990s (1996-2000). While the annual number of device advisories did not change significantly, ICD advisories became more frequent and a three-fold increase in the number of devices affected per advisory was observed. The number of devices affected by hardware advisories increased three-fold, due primarily to a 700-fold increase in electrical/circuitry abnormalities and a 20-fold increase in potential battery/capacitor malfunctions. Other types of hardware abnormalities (defects in the device header, hermetic seal, etc.) became less common. The number of devices recalled due to firmware (computer programming) abnormalities more than doubled. The remarkable technological advances in pacemaker and ICD therapy have been accompanied by changing patterns of device advisory type. Accurate, timely physician and patient notification systems, and routine pacemaker and ICD patient follow-up continue to be of paramount importance.

Chi-Square Distribution↗
PubMed2000

Inappropriate shocks diagnosed by stored electrograms of implantable cardioverter defibrillators--two case reports.

An implantable cardioverter defibrillator is an important therapeutic option for patients with high risk of life-threatening ventricular arrhythmias. However, their use is also associated with several complications including inappropriate shock. Although the most frequent cause of inappropriate shock is supraventricular tachyarrhythmias, lead fracture can also be associated with inappropriate shock. Diagnosis of lead fracture can be made by chest x-ray radiography, fluoroscopic examination, interrogation of the device, and intracardiac electrograms. In this report, the authors present two cases of inappropriate shock due to lead fractures in the costoclavicular region that could only be diagnosed by the help of stored intracardiac electrograms. Methods for diagnosis of lead fractures and modalities to avoid recurrences are also discussed.

Artifacts↗
PubMed2004

Indications for an implantable cardioverter defibrillator (ICD).

Since the first clinical use of implantable defibrillator in human, the technology and the function of implantable cardioverter-defibrillator (ICD) have been much improved and now, ICD can be implanted within the chest wall. ICD is the most reliable therapy to prevent sudden cardiac death (SCD) in patients with documented VT/VF and the efficacy is most clear in patients with depressed heart function. It is now extended as a tool of the primary prevention of SCD in high risk patients after myocardial infarction. However, such beneficial effect is not applicable to DCM though patients might have depressed heart function. ICD is not free from procedure- or device-related problems which need to be resolved. From unknown causes, VT/VF might recur in an incessant form and an emergency admission is needed. Therefore, even during ICD therapy, patients often require antiarrhythmic drugs or catheter ablation.

Death, Sudden, Cardiac↗
PubMed2004

Implantable cardioverter defibrillators in children.

The use of implantable cardioverter defibrillators in children presents several unique challenges for the pediatric cardiologist. Size considerations and hardware limitations are important in the current generation of devices that are not designed with children in mind. Defibrillator devices are used to prolong life, which may have significant implications for leads and electrodes that are affixed to the heart in a child who has continued growth potential. A greater number of children with congenital heart defects are surviving into adulthood, many of whom have a risk of late sudden death following repair. These patients may also have unique anatomic considerations that may affect device placement. This article will address some of the issues faced when considering the use of implantable-defibrillator therapy in the pediatric population.

Arrhythmias, Cardiac↗
PubMed1994

Effectiveness of noninvasive programmed stimulation for initiating ventricular tachyarrhythmias in patients with third-generation implantable cardioverter defibrillators.

Previous generations of implantable cardioverter defibrillators (ICDs) required invasive electrophysiological testing to assess defibrillator function. Newer third-generation ICDs include the capability for performing noninvasive programmed stimulation (NIPS) and may reduce the need for invasive studies to assess tachycardia recognition and antitachycardia therapy algorithms. The effectiveness of ICD-based NIPS for the induction of ventricular arrhythmias has not, however, been formally assessed. Third-generation ICDs were implanted in 79 patients, who underwent a total of 166 postoperative defibrillator tests. NIPS with rapid ventricular pacing was performed in all patients in an attempt to induce ventricular fibrillation. In patients with prior sustained uniform ventricular tachycardia, programmed stimulation with up to three extrastimuli was performed in order to attempt to initiate the clinical ventricular tachcardia. Ventricular fibrillation was induced with NIPS in 146 of 166 studies (88%). Ventricular tachycardia was initiated with NIPS in 104 of 123 studies (85%). The type of defibrillator and the use of endocardial or epicardial rate sensing/pacing leads did not influence the efficacy of NIPS. NIPS with third-generation ICDs is generally effective at inducing ventricular fibrillation and clinically relevant ventricular tachycardias, and reduces the need to perform invasive electrophysiological testing following device implantation. In a minority of patients temporary transvenous pacing catheters must still be used to facilitate arrhythmia induction.

Adult↗
PubMed1994

Implantable cardioverter defibrillator compared with antiarrhythmic drug treatment in cardiac arrest survivors (the Cardiac Arrest Study Hamburg).

In 1987, the Cardiac Arrest Study Hamburg (CASH), a prospective, multicenter, randomized controlled study, was started in survivors of sudden cardiac death resulting from documented ventricular tachyarrhythmias. Through December 1991, 230 survivors (46 women, 184 men; mean age 57 +/- 11 years) of cardiac arrest caused by ventricular tachyarrhythmias were randomly assigned to receive either oral propafenone (56 patients), amiodarone (56 patients), or metoprolol (59 patients) or to have an implantable defibrillator (59 patients) without concomitant antiarrhythmic drugs. The primary endpoint of the study was total mortality. In March 1992, the propafenone arm of CASH was stopped because of excess mortality compared with the implantable defibrillator group. This article presents preliminary results of the comparison of implantable defibrillator therapy with propafenone therapy. A significantly higher incidence of total mortality, sudden death (12%), and cardiac arrest recurrence or sudden death (23%) was found in the propafenone group compared with the implantable defibrillator-treated patients (0%, p < 0.05). It was concluded that, in survivors of cardiac arrest, propafenone treatment is less effective than implantable defibrillator treatment.

Amiodarone↗
PubMed2006

Proportion of patients followed in a specialized heart failure clinic needing an implantable cardioverter defibrillator as determined by applying different trial eligibility criteria.

Numerous trials have demonstrated survival benefits using implantable cardioverter defibrillators (ICDs) for primary prevention in selected patients with left ventricular (LV) systolic dysfunction. However, eligibility criteria differed across these trials. Without a risk stratification scheme that clearly identifies those who will benefit, there remains debate about which patients with heart failure (HF) should receive ICDs for primary prevention. To explore the implications of applying different eligibility criteria, this study evaluated all patients seen in a specialized HF clinic from August 2003 to January 2004. Of the 309 consecutive patients in the cohort, 46 were excluded because their HF complicated recent myocardial infarcts (n = 3); their LV ejection fractions were not measured (n = 9); or their HF was due to valvular disease, myocarditis, or peripartum cardiomyopathy (n = 34). The Multicenter Automatic Defibrillator Implantation Trial-II criteria were met by 85 patients (32%), and 134 patients (51%) met the Sudden Cardiac Death in Heart Failure Trial criteria. Even allocation decisions based on randomized trial evidence can have vastly different resource implications depending on which trial is chosen. Thus, the development and validation of a risk stratification scheme to identify those patients most likely to benefit from ICDs for primary prophylaxis should be a research priority.

Aged↗
PubMedDate not supplied

Indications for and long-term survival in patients with automatic implantable cardioverter-defibrillators.

Automatic implantable cardioverter-defibrillators (AICDs) were implanted in 378 men and 95 women, mean age 69 +/- 12 years. At 3.6-year follow up, survival was 76% in patients who had an AICD because of cardiac arrest as a result of ventricular fibrillation or ventricular tachycardia not resulting from a transient or reversible cause; 85% in patients who had an AICD because of spontaneous sustained ventricular tachycardia in association with structural heart disease; 92% in patients who had an AICD because of syncope of undetermined origin with clinically relevant, hemodynamically sustained ventricular tachycardia or ventricular fibrillation induced at electrophysiological study when drug therapy is ineffective, not tolerated, or not preferred; 84% in patients who had an AICD because of nonsustained ventricular tachycardia with coronary artery disease, prior myocardial infarction, left ventricular dysfunction, and inducible ventricular fibrillation or sustained ventricular tachycardia at electrophysiological study that is not suppressible by a class I antiarrhythmic drug; and 85% in all 473 patients who had an AICD.

Aged↗
PubMed2005

Clinical course and implantable cardioverter defibrillator therapy in postinfarction women with severe left ventricular dysfunction.

BACKGROUND: There are limited data regarding implantable cardioverter defibrillator (ICD) therapy in postinfarction women with severe left ventricular dysfunction. The aim of this study was to evaluate the risk of cardiac events and effects of ICD therapy in women as compared to men enrolled in the Multicenter Automatic Defibrillator Implantation Trial II (MADIT II). METHODS AND RESULTS: Among 1,232 patients enrolled in MADIT II, there were 192 (16%) women and 1,040 (84%) men. When compared to men, women had an increased frequency of NYHA class > or =II (70 vs 63%; P = 0.067), hypertension (60% vs 52%; P = 0.047), diabetes (42% vs 34%; P = 0.027), and LBBB (25% vs 17%; P = 0.011), and less frequent CABG surgery (42% vs 60%; P < 0.001). The 2-year cumulative mortality in patients randomized to conventional therapy was not significantly different in women and men (30% and 20%, respectively; P = 0.19). Adjusting for relevant clinical covariates, the hazard ratios for ICD effectiveness were similar in women (0.57; 95% CI = 0.28-1.18; P = 0.132) and men (0.66; 95% CI = 0.48-0.91; P = 0.011). The risk of appropriate ICD therapy for VT/VF was lower in women than in men (hazard ratio = 0.60 for female vs male gender; 95% CI = 0.37-0.98; P = 0.039). CONCLUSIONS: MADIT II women had similar mortality and similar ICD effectiveness when compared to men. MADIT II women with ICDs had a lower risk of arrhythmic events with fewer episodes of ventricular tachycardia than men.

Aged↗
PubMed2005

Time to resumption of driving after implantation of an automatic defibrillator (from the Dual chamber and VVI Implantable Defibrillator [DAVID] trial).

The time to resumption of driving after insertion of an implantable cardioverter-defibrillator (ICD) was evaluated in the Dual Chamber And VVI Implantable Defibrillator trial. Most patients were advised not to drive for 3 to 6 months after the ICD was implanted. Patients were surveyed at 3-, 6-, or 9-month intervals to characterize their driving habits, with 101 of 137 (73.7%), 98 of 146 (67.1%), and 79 of 135 (58.5%) responding. Of respondents, 82% recalled being told not to drive for a specified time after ICD implantation. These patients generally obeyed recommendations (association between recommended time and time of resumption, p <0.001) from medical personnel.

Arrhythmias, Cardiac↗
PubMed2002

Current clinical perspectives on implantable devices for atrial defibrillation.

The role of devices that deliver shock therapy for atrial fibrillation is still debated. Following technical improvements in catheter-based atrial defibrillation, implantable devices have become available either in the form of stand-alone atrial defibrillators or in the form of dual defibrillators. Although preliminary results do not support their use as a single, unique treatment for atrial fibrillation patients, in combination with drugs, pacing or other treatments such as ablation, atrial defibrillators should help appropriately selected groups of patients.

Atrial Fibrillation↗