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Implantation of an automatic defibrillator using a new nonthoracotomy approach.

Most current nonthoracotomy systems for defibrillator implantation use monophasic devices. To determine the safety and efficacy of a new nonthoracotomy lead configuration when used in conjunction with a device that used biphasic waveforms, 38 consecutive patients were taken to the operating room for implantation of a Cadence tiered therapy defibrillator system. The lead system consisted of a transvenous coil electrode positioned at the right atrial-superior vena caval junction, a bipolar endocardial right ventricular lead, and a large patch placed subcutaneously near the cardiac apex. Of the 38 nonthoracotomy defibrillator implantations attempted, 36 (95%) were completed with adequate defibrillation thresholds. The mean defibrillation threshold in these 36 patients was < or = 563 +/- 10 V (< or = 20 +/- 1 J). There was no perioperative mortality. Complications included coil lead migration (5), sensing lead migration (1), infection (3), pneumothorax (2), arterial embolism (1), and folding of the subcutaneous patch with an increase in defibrillation threshold (1). No patient died during a median follow-up period of 22 weeks. Fourteen patients (39%) had spontaneous sustained ventricular tachyarrhythmias, which were all successfully terminated by the implanted device. Shocks for nonsustained arrhythmias were aborted in eight patients (22%). Spurious discharges for sinus tachycardia or atrial fibrillation occurred in six patients (17%) and were readily diagnosed by examination of the stored electrograms. Thus, implantation of a biphasic tiered therapy defibrillator system using this nonthoracotomy approach is feasible in the majority of patients. The major complication associated with this procedure is lead dislodgment.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

A critical appraisal of indications for the implantable cardioverter defibrillator (ICD).

The implantable cardioverter defibrillator (ICD) is a remarkably effective therapy for reducing sudden cardiac death in patients with malignant ventricular arrhythmias. The indications for implantation of the ICD were approved in 1985 by the United States Food and Drug Administration; it could be implanted in patients who have experienced cardiac arrest or in those with recurrent ventricular arrhythmias which are not suppressed by anti-arrhythmic drugs in the electrophysiology laboratory. These established indications have not changed in the last seven years. In the near future, the release of third-generation ICDs (with antitachycardia pacing) will likely further expand indications for the device. Many patients with stable ventricular tachycardia who have not had syncope or cardiac arrest will receive a third-generation defibrillator. Also, three clinical trials now in progress--CABG-PATCH, Multicenter Automatic Defibrillator Implantation Trial (MADIT) and Multicenter Unsustained Tachycardia Trial (MUSTT)--are studying "pre-event" patients with low ejection fraction and electrical instability; some of the patients in each trial are being prospectively randomized to the ICD. Within the next five years we will have a better understanding of the role of ICD therapy in such patients. Until these studies are completed, it is important that the indications for the ICD not be expanded.

Arrhythmias, Cardiac↗

Direct current application: easy induction of ventricular fibrillation for the determination of the defibrillation threshold in patients with implantable cardioverter defibrillators.

For the determination of the defibrillation threshold, the induction of ventricular fibrillation is mandatory. However, in severely damaged hearts it is sometimes difficult to induce ventricular fibrillation by rapid stimulation or alternating current. Only rapid nonclinical ventricular tachycardias may result, and their cardioversion threshold may be different from the defibrillation threshold. Therefore, it was the purpose of this study to test the potential of direct current (DC) application to rapidly induce ventricular fibrillation in patients with an implanted cardioverter defibrillator. The defibrillation threshold had to be determined in 13 patients (9 with coronary heart disease, 4 with dilative cardiomyopathy, ejection fraction 35%) during and 2 weeks after the implantation of a cardioverter defibrillator. DC was applied 37 times by a commercially available 9-V DC battery via a bipolar catheter for about 3 seconds. Ventricular fibrillation was induced 23 times (62%) and rapid nonclinical ventricular tachycardias were induced six times (16%). In one patient clinical ventricular tachycardia was observed. In seven instances (19%) sinus rhythm remained. In 12 of the 13 patients, ventricular fibrillation could be induced by DC. Thus, the induction of ventricular fibrillation by DC application may serve as an additional tool to induce ventricular fibrillation, determining the defibrillation threshold in implantable cardioverter defibrillator patients.

Cardiac Catheterization↗

[Distribution of electric potentials in intra- and extracardiac defibrillation].

The implantable defibrillator is a device to treat refractory ventricular tachyarrhythmias. This study was done to evaluate the determinants of defibrillator performance which are not known completely. Different defibrillation electrodes were attached to beating and non-beating isolated pig-hearts (n = 15) and the electric field resulting from defibrillation measured over a distance of 3 mm. From 5 to 20 J a non-linear relation was found between delivered shock energies and the amplitudes of the recorded voltage waveforms. Using two patch electrodes maximal amplitudes were monitored apical in the right (4.6 +/- 0.5 V) and left ventricle (2.1 +/- 0.3 V). The atria only showed 10-25% of the maximal amplitudes. The combination of a patch and a catheter electrode showed similar efficiency. Two catheter electrodes reduced the apical (1.2 +/- 0.1 V) and increased the atrial amplitude (0.75 +/- 0.06 V). The recorded amplitudes in myocardium were half as much compared with blood-/sodium chloride indicating the twofold higher resistance of myocardial tissue. These experiments quantify the dependence of the efficiency of automatic implantable defibrillator systems on the sort and localization of the defibrillation electrodes.

Animals↗

[Clinical experience with a second-generation cardioverter-defibrillator].

Implantable cardioverter defibrillators (ICD's) are effective for reducing mortality in refractory malignant ventricular arrhythmias (MVA). Second generation ICD's (Telectronics Guardian 4202/4203) were implanted in 7 patients (all male, mean age 58.1 years) with ventricular fibrillation (VF) in 2, ventricular tachycardia (VT) in 1, and both VF and VT in 4. Underlying heart disease was coronary artery disease in 4 patients, and valvular heart disease, dilated cardiomyopathy and no obvious cause (documented primary VF, reproducible at electrophysiologic study) in 1 patient each. Mean ejection fraction was 40 +/- 14%. Mean defibrillation threshold of the two epicardial patches at implantation by means of median sternotomy was 18 +/- 9 joule, and patch impedance 35 +/- 7 ohms. Post defibrillation bradypacing via epicardial electrode was programmed in 5 patients (70%). Mean follow-up was 10.1 months (1-25 months). Successful defibrillation of 28 spontaneous VT/VF episodes was noted in 2 patients, while the other 5 have had no further episodes of MVA so far. One device was explanted following tissue necrosis at the battery site after a MVA-recurrence-free interval of 15 months. The reconfirmation algorithm prevented false shock delivery in 2 patients.

Cardiac Pacing, Artificial↗

Induction of atrial fibrillation with low-energy defibrillator shocks in patients with implantable cardioverter defibrillators.

In a population of 151 consecutive patients who received an implantable cardioverter defibrillator, we found that atrial fibrillation was induced by low-energy shocks in 19% and was most common in patients with lead systems that included a right atrial electrode. Our finding that there was a fixed relation between the energy required to fibrillate (< or = 3 J) and defibrillate (> 3 J) suggests the presence of an upper limit of vulnerability in the human atrium.

Aged↗

Measurement of body surface energy leakage of defibrillation shock by an implantable cardioverter defibrillator.

Leakage of electrical current from the body surface during a defibrillation shock delivery by an ICD device was evaluated in 27 patients with life-threatening ventricular tachyarrhythmias. All patients underwent the implantation of the Medtronic Jewel Plus ICD system, and the defibrillation shocks were delivered between the active can implanted in the left subclavicular region and the endocardial lead placed in the right ventricle. At the time of measurement of the effect of electrical energy delivery for defibrillation, the shocks were delivered in a biphasic form at the energy level of 20 or 30 J. During each delivery of the defibrillation shock, the electrical current to the body surface was measured through large skin electrodes (6.2 cm2) that were pasted at the following positions: (1) parallel position: the electrodes were placed at the left shoulder and the right low-chest, and the direction of the electrode vector was parallel to the direction of the defibrillation energy flow, and (2) cross position: the electrodes were placed at the right shoulder and the left low-chest, and the vector of the electrodes was roughly perpendicular to the direction of the energy flow. The energy leakages were measured in 80 defibrillation shocks. The peak leakage current during the shock delivery at energy of 30 J was 48 +/- 26 mA at the parallel position and 19 +/- 15 mA at the cross position (P = 0.0002). The energy leakage at a 30-J shock was 7.4 +/- 7.2 mJ at the parallel position and 1.4 +/- 2.3 mJ at the cross position (P = 0.0002). The actual maximum energy leakage was 105 mA, 29 mJ, and 106 V that appeared at the parallel position. The body surface leakage of the defibrillation energy of the ICD device was evaluated. The power of the energy leakage strongly depended on the angle between the alignment of the recording electrodes and the direction of the energy flow. The highest current leakage to the body surface reached a considerable level, but the energy leakage was small because of the short duration of the defibrillation shock.

Adult↗

Low incidence of lead related complications associated with nonthoracotomy implantable cardioverter defibrillator systems.

UNLABELLED: Implantable cardioverter defibrillators (ICDs) are increasingly being implanted without the need for thoracotomy. Long-term lead performance and stability were evaluated in 150 consecutive patients in whom 1 of 3 nonthoracotomy ICD lead systems was implanted over a 3-year period from September 1990. RESULTS: Twelve (8%) patients (7 males, 5 females) experienced 13 lead complications during a follow-up period of 12 +/- 10 months. Complications were related to intracardiac leads in 7 (4 dislodgments, 2 fractures, 1 right ventricular perforation) and patch leads in 6 (2 folding, 1 fracture, 1 erosion, and 2 hematomas) cases. Freedom from lead related complications at 1 year was 92% (95% confidence interval, 86%-95%). A significant difference in freedom from lead complications between the two most frequently implanted lead systems was observed (P = 0.02). Complication rates were similar in the initial 75 and the more recent 75 implants (P = 0.5). The median time between lead implant and detection of complications was 37 days (range 3-1,147). Complications were diagnosed before hospital discharge in only two cases. In five patients, complications were asymptomatic and in three of these, reoperation was required due to inadequate defibrillation thresholds. Reoperation was necessary in 9 of 12 patients. CONCLUSIONS: Nonthoracotomy ICD lead systems are associated with a low complication rate. Complications may or may not cause symptoms, usually occur after hospital discharge, and require reoperation. Complications are not related to a "learning curve." There is a significant difference in performance between different lead systems.

Defibrillators, Implantable↗

Automatic implantable cardioverter-defibrillators in Chagas' heart disease patients with malignant ventricular arrhythmias.

A total of 46 consecutive Chagas' disease patients had an automatic cardioverter defibrillator implanted at our institution from October 1998 to January 2004. A retrospective longitudinal study was carried out to identity type of life-threatening ventricular arrhythmias as well as type of therapy delivered. Of these, 41 (91%) had been recovered from cardiac arrest. Five (15%) of 33 patients in whom echocardiography was done had no left ventricular function. Antiarrhythmic therapy was delivered to 37 (80%) patients during postimplant follow-up. Thirty-one of 37 (84%) patients received both shock and antitachycardia pacing, five (13%) only antitachycardia pacing, and one (3%) patient only shock. Median time to first shock was 16 days, varying from 1 to 576 days. Ventricular fibrillation was the cause of first shock in 12 patients (32%), ventricular tachycardia in 11 (29%), and ventricular tachycardia not responding to antitachycardia pacing degenerating into ventricular fibrillation in nine (24%). Five patients with ventricular tachycardia were treated with antitachycardia pacing. Probability of freedom from device discharged was 47% at 90 days, 34% at 180 days, and 9% at 360 days in the postimplant follow-up. Thus, patients with chronic Chagas' heart disease recovered from cardiac arrest have a peculiar arrhythmogenic profile characterized by a high frequency of ventricular fibrillation and no left ventricular systolic dysfunction and a short period of time for first shock.

Brazil↗

The effects of normothermic and hypothermic cardiopulmonary bypass on defibrillation energy requirements and transmyocardial impedance. Implications for implantable cardioverter-defibrillator implantation.

The influence of normothermic and hypothermic cardiopulmonary bypass on defibrillation energy requirements and transcardiac impedance is not well characterized. However, this relationship is of clinical importance during automatic defibrillator implantation done with concomitant cardiac surgery, and there is anecdotal information that criteria for successful implantation are harder to achieve after such operations. We studied the effect of controlled hypothermia on defibrillation energy requirements and transcardiac impedance in a canine model of cardiopulmonary bypass in which 26 animals underwent right atrial and femoral arterial cannulation, as well as continuous hemodynamic and intramyocardial temperature monitoring. The defibrillation energy requirements were evaluated at 60-minute intervals with an epicardial patch system, and transcardiac impedance was measured before and after the multiple inductions and terminations of ventricular fibrillation. In group 1 (n = 10) defibrillation energy requirements were evaluated immediately after initiation of cardiopulmonary bypass at 37 degrees C (T0), after gradual cooling to 28 degrees C (T1), and after rewarming to 37 degrees C (T2). Group 2 (n = 16) comprised time controls that were identically instrumented and studied, but maintained at 37 degrees C throughout. Percent successful defibrillation was plotted against delivered energy, and the raw data fit by logistic regression. The energy at which 50% of shocks were successful (E50) was 3.23 +/- 0.89 joules at T0, 5.12 +/- 1.85 joules at T1, and 4.42 +/- 1.22 joules at T2 in group 1; this was not significantly different from the corresponding group 2 E50 values, which were 3.11 +/- 1.39 joules, 4.95 +/- 2.47 joules, and 5.59 +/- 3.18 joules, respectively. Both groups demonstrated a significant increase in E50 during the first hour of cardiopulmonary bypass (mean increase from T0 to T1 was 1.89 joules in group 1 and 1.84 joules in group 2, p < 0.05). Transmyocardial impedance fell progressively during the group 2 experiments from 73.6 +/- 12.9 omega at the beginning of the T0 shock series to 61.4 +/- 8.9 omega at the end of the T2 shock series. A similar reduction in transmyocardial impedance was observed during the course of all the group 1 experiments; however, at the beginning of the T1 shock series impedance was significantly elevated to 77.4 +/- 12.3 omega (p < 0.05 compared with group 2 and with end T0 in group 1). There was no relationship between defibrillation energy requirements and transcardiac impedance; there was also no correlation between either of these parameters and intramyocardial extracellular pH or left ventricular end-diastolic pressure.(ABSTRACT TRUNCATED AT 400 WORDS)

Animals↗

Nonthoracotomy implantable cardioverter defibrillator placement in children: use of subcutaneous array leads and abdominally placed implantable cardioverter defibrillators in children.

INTRODUCTION: The need to access the right ventricle might preclude transvenous placement of a defibrillation lead at implantable cardioverter defibrillator (ICD) placement, especially in small children or children with complex congenital heart defects. We investigated a subcutaneous array lead in addition to an abdominally placed "active can" ICD device in two children to avoid a thoracotomy. METHODS AND RESULTS: The first child (age 12 years, 138 cm, 41 kg) had transposition of the great arteries with a subsequent surgical intra-atrial correction by the Mustard technique. The second child (age 14 years, 161 cm, 54 kg) had a single atrium and a single ventricle, d-transposition of the aorta, and atresia of the main pulmonary artery with a surgical anastomosis between the aorta and the right pulmonary artery by the Cooley technique. The defibrillation threshold was 18 J and <20 J at initial implantation and at generator replacement in the first patient and 20 J in the second patient. During follow-up of 6 years and 1 month, respectively, no ICD-related complications occurred. CONCLUSION: In children in whom endocardial, right ventricular placement of a defibrillation lead is precluded, defibrillation is possible and safe between an abdominally placed "active can" ICD device and a subcutaneous array lead. This approach may avoid a thoracotomy in children with no possibility for transvenous ICD placement.

Abdomen↗

Cardiac release of histamine after ventricular fibrillation and defibrillation during insertion of implantable cardioverter defibrillators (ICD).

Histamine has inotropic, chronotropic, arrhythmogenic, and vasoactive effects, and is released from the heart in ischaemia-reperfusion injury. The effect of ventricular fibrillation (VF) and defibrillation (DEF) on histamine release was investigated in 9 anaesthetized patients undergoing transvenous implantation of ICD. Concomitant arterial and coronary sinus (CS) blood samples were drawn before induction of VF (duration 20 seconds), immediately after, and 2 and 5 min after DEF (18-24 Joules). Basal arterial histamine was 2.5 +/- 6 nmol/l, and did not increase after VF. The histamine level in CS was 1.1 +/- 0.2 nmol/l before VF (p < 0.008 compared to arterial), and increased to 2.5 +/- 0.6 nmol/l immediately after (p < 0.045 compared to basal), to 3 +/- 1.1 nmol/l 2 min after (p < 0.45), and to 2.4 +/- 0.8 nmol/l 5 min after VF. In the basal state there was an uptake of histamine across the coronary circulation. After VF/DEF the level of histamine increased in coronary venous blood, suggesting cardiac release of histamine.

Aged↗

Defibrillation efficacy comparing a subcutaneous array electrode versus an "active can" implantable cardioverter defibrillator and a subcutaneous array electrode in addition to an "active can" implantable cardioverter defibrillator: results from active can versus array trials I and II.

INTRODUCTION: Placement of implantable cardioverter defibrillators (ICDs) has been simplified by using the shell of a pectorally implanted ICD as a defibrillation electrode in combination with an endocardial right ventricular defibrillation lead. However, a sufficiently low defibrillation threshold (DFT) cannot be obtained in a few patients. Therefore, alternative approaches were systematically tested in the Active Can versus Array Trial (ACAT). METHODS AND RESULTS: In the first of two prospective randomized studies, the DFT of a subcutaneous left dorsolateral array anode introduced from a pectoral incision was compared to that of a standard active can anode in 68 patients. Intraoperatively, the DFT was determined twice in each patient using either the active can or, in patients with a subcutaneous array lead, once with all three fingers and once omitting the middle finger of the array. The second prospective randomized study included 40 patients. DFT also was determined twice in each patient using an active can in a left pectoral position as anode alone and combined with a left dorsolateral array electrode with two fingers. In ACAT I, stored energy at DFT decreased from 13.1+/-7.7 J (active can) to 9.6+/-6.1 J (three-finger array lead) (P = 0.04), impedance decreased from 53+/-8 ohms to 40+/-6 ohms (P < 0.0001). Omitting the middle finger of the array lead, stored energy at DFT increased by 0.9 J (P = 0.47) and impedance by 2 ohm (P < 0.0001). In ACAT II, DFT and impedance using an active can device were significantly lower when a two-finger array lead was added that decreased stored energy at DFT from 10.1+/-5.2 J to 6.9+/-3.9 J (P = 0.001) and impedance from 56+/-5 1 to 42+/-5 l (P < 0.0001). CONCLUSION: In combination with a right ventricular defibrillation electrode, a left pectoral subcutaneous array lead improves defibrillation efficacy if used instead of, or in addition to, a left pectoral active can ICD device. Implantation of the array lead can be simplified by using two instead of three fingers, without a significant loss of defibrillation efficacy.

Adult↗

Implantation of cardioverter defibrillators in the post-sternotomy patient.

In an attempt to minimize the hazards of redo sternotomy or thoracotomy in patients who have undergone previous cardiac procedures, a technique has been developed for cardioverter defibrillator implantation that involves dissection through a left subcostal incision and placement of extrapericardial defibrillation patches. This approach was used in 22 consecutive patients who required an implantable cardioverter defibrillator 4 to 156 months after previous median sternotomy. Defibrillation threshold energy was less than or equal to 20 J in every patient. Ninety-one percent of patients were extubated during the first 24 hours and were transferred out of the intensive care unit by the second postoperative day. One patient died of an acute myocardial infarction 3 days postoperatively (1/22, 4.5%). It was necessary to replace one lead for mechanical failure of an adapter, one patch required repositioning, and 1 patient needed drainage of a persistent pleural effusion (3/22, 13.6%). No further complications occurred during 3 to 27 months of follow-up. Advantages of the subcostal approach included prompt extubation, a single incision, and minimal morbidity. This approach is safe and effective, and is the method of choice for implantation of a cardioverter defibrillator in patients who have undergone prior sternotomy.

Adult↗

Implantable cardioverter defibrillators in Israel: utilization and implantation trends.

BACKGROUND: Since its introduction, the implantable cardioverter defibrillator (ICD) has evolved to its present status as the dominant therapeutic modality for patients with life-threatening arrhythmias. Several randomized studies have shown the benefit of ICD implantation as the first choice of treatment for primary as well as secondary indications for ventricular arrhythmias. Therefore, it is expected that the use of ICDs will increase further. The main objectives of this study were to analyze the Israeli experience with ICD implantation from 1993 to 1999, to examine the diffusion of ICD therapy in Israel and the evolution of implantation patterns and indications. METHODS: We conducted a retrospective review and analysis of an ICD registry for the period of January 1993-December 1999. Data collected included demographic, administrative, clinical and survival data. RESULTS: A total of 732 new implantations were identified and reviewed. The mean length of follow up of all patients was 30.7+/-21.1 months. 86% of patients were males and the mean age at implantation was 62.6+/-12.4 years. 79% of patients had CAD and the mean EF of all patients was 29.2+/-11.2%. 135 patients (18.4%) died during follow-up. One, two and three-year survival rates were calculated and were 92.7%, 87.8% and 82.0% respectively. A steady increase in implantation rate and in implanting centers was observed over the years. CONCLUSIONS: ICD therapy is relatively expensive; therefore a national registry which is continuously monitored may be the most expedient method to follow clinical and economic aspects of the utilization of this therapeutic modality.

Aged↗

Transvenous defibrillator systems implanted by electrophysiologists in the catheterization laboratory.

BACKGROUND: A significantly lower perioperative mortality has established the nonthoracotomy approach as the preferred technique in implantable cardioverter defibrillation (ICD) implantation. With the currently available transvenous endocardial leads in combination with the expanded use of biphasic ICD devices, the need for use of an additional subcutaneous lead has almost been eliminated. Thus, implantation of these systems has been simplified and reports have appeared in the literature that the procedure can now be performed by an electrophysiologist alone without surgical assistance in the electrophysiology or catheterization laboratory. HYPOTHESIS: The purpose of this study was to investigate the feasibility and safety of ICD implantation by an electrophysiologist in a procedure performed entirely in the catheterization laboratory without the assistance of a surgeon. METHODS: Over a period of 28 months, we implanted transvenous ICDs in 40 consecutive patients with (n = 34) and without (n = 6) use of general anesthesia in the catheterization laboratory with minor surgical assistance in abdominal pocket fashioning for the first two cases and then working alone for the remainder. The study included 36 men and 4 women, aged 59 +/- 12.5 years, with coronary artery (n = 22) or valvular heart disease (n = 4), cardiomyopathy (n = 12), and long QT syndrome (n = 1) or idiopathic ventricular tachycardia (n = 1), and a mean left ventricular ejection fraction of 34%, who presented with ventricular tachycardia (n = 30) or ventricular fibrillation (n = 10). RESULTS: One-lead ICD systems (Endotak, n = 21; Transvene, n = 8; or EnGuard, n = 1) were used in 30 patients, and 2-lead (EnGuard, n = 5 or Transvene, n = 5) systems in 10 patients. Generators were implanted in an abdominal (n = 17) or pectoral (n = 23) pocket. Active can devices were employed in 17 patients. The defibrillation threshold averaged 9 J. All implants were entirely transvenous with no subcutaneous patch. Biphasic ICD devices were employed in all patients. There were three complications (8%); one pulmonary edema that responded to drug therapy, one lead insulation break that required reoperation on the third day, and one pocket hematoma in a patient receiving anticoagulation, with no need for evacuation. There were no operative deaths and no infections. After implant, patients were discharged at a mean of 3 days. All devices functioned well at predischarge testing. During follow-up (12 +/- 8 months), 20 patients received appropriate and 5 patients inappropriate shocks. Three patients died of pump failure at 3, 7, and 19 months, respectively; they had received 0, 42, and 15 appropriate shocks, respectively, over these months. Another patient succumbed to a myocardial infarction at 9 months. At 6 months, one patient developed subacute subclavian vein thrombosis which resolved with anticoagulation therapy. CONCLUSIONS: Current transvenous biphasic ICD systems allow experienced electrophysiologists to implant them safely alone in the catheterization laboratory without surgical assistance, even for abdominal implants, with a high success rate and no need for use of a subcutaneous patch.

Adult↗

Cardiomyoplasty and implantable cardioverter defibrillator: efficacy and safety of concomitant device implantation: sudden death and cardiomyoplasty.

Sudden death represents a common event in the natural history of patients affected by chronic heart failure. Such an outcome also has been shown to characterize the follow-up of the cardiomyoplasty procedure. We report two cases of patients who had cardiomyoplasty and experienced witnessed episodes of ventricular arrhythmia at variable times after surgery (2 years and 2 months, respectively). In the first case, an implantable cardioverter defibrillator (ICD) was implanted subsequent to the arrhythmic episode, whereas the second patient had a combined cardiomyoplasty and ICD implantation procedure. In particular, this patient underwent a modified wrapping technique, herein described, because of a large left ventricular dilatation. In both cases, ventricular defibrillation did not affect the correct functioning of the implanted cardiomyostimulator. Our article confirms that ventricular arrhythmia is common in cardiomyoplasty patients. The combined use of a skeletal muscle stimulator and implantable defibrillator may therefore be effective in preventing arrhythmia-related sudden death without any concurrent effect on the correct functioning of the wrapped muscle/heart circuit, with likely benefit on long-term cardiomyoplasty patient survival.

Aged↗

Indications for implantable cardioverter defibrillator therapy.

The implantable cardioverter defibrillator (ICD) is now an integral therapy for cardiac patient care. More than 20 years have passed since the first ICD implant. Sudden cardiac death from arrhythmia (ventricular tachycardia and fibrillation) has been significantly decreased because of the use of ICD therapy. Primary treatment trials have shown ICD therapy to be superior to drug therapy. Most of these trials compared ICD therapy with amiodarone or sotalol. Prevention trials have also been completed. Patients with nonsustained ventricular tachycardia, low left ventricular ejection fraction, and coronary artery disease were evaluated with electrophysiology studies. Patients with inducible ventricular arrhythmias were treated with ICD or drug suppression therapy. ICD therapy was superior to drug therapy for prevention of fatal arrhythmias. Ongoing trials include evaluation of ICD therapy for patients with high-risk substrates: congestive heart failure, dilated cardiomyopathy, hypertrophic cardiomyopathy, and repolarization syndromes. Factors such as medication inefficacy/side effects, transvenous ICD implantation and overwhelming mortality benefits have expanded ICD usage beyond the original restrictive guidelines.

Clinical Trials as Topic↗