Changes in the Amplitude of Endocardial Electrograms Following Defibrillator Discharge: Comparison of Two Lead Systems

Changes in the amplitude of endocardial electrograms after an unsuccessful shock attempt have been demonstrated to cause failure of redetection of ventricular fibrillation in patients using an integrated sense-pace defibrillating lead system. Thus, the objective of this study was to compare the effects of defibrillator shocks on the amplitude of endocardial electrograms in 26 patients using two different nonthoracotomy systems, a previous lead (model 0062) or a redesigned version (model 0072). At implant, bipolar endocardial electrograms were obtained before each shock application, during initial detection and redetection of ventricular fibrillation in case the applied shock was unsuccessful, and during intervals of 5, 10, 20, 30, 60, and 120 seconds after each shock delivery. No significant difference was noted in endocardial amplitudes between the lead models 0062 and 0072 during baseline sinus rhythm (12.2 ± 4.6mV vs 11.4 ± 3.8 mV), and during initial ventricular fibrillation (7.0 ± 2.4 mV vs 7.6 ± 2.3 mV). During redetection of ventricular fibrillation, however, there was a significant difference (P = 0.0006) in endocardial amplitudes (3.4 ± 1.9 mV vs 6.6 ± 2.3 mV) between both leads tested. Comparing lead models 0062 and 0072, marked differences were found in endocardial amplitudes during sinus rhythm 5, 10, and 20 seconds after successful arrhythmia termination: 2.8 ± 1.9 mV vs 8.6 ± 2.9 mV (P < 0.0001), 4.6 ± 2.9 mV vs 9.2 ± 3.2 mV (P = 0.0007), and 6.4 ± 4.0 mV vs 10.5 ± 3.6 mV (P = 0.01). At predischarge testing, failure of redetection of ventricular fibrillation was documented in two patients with the lead model 0062 requiring external defibrillation to restore sinus rhythm. These findings demonstrate a significant less postshock attenuation of the endocardial electrogram amplitudes during persistent ventricular fibrillation after an unsuccessful shock attempt as well as during sinus rhythm immediately following an effective shock delivery using the redesigned lead system model 0072 compared to the electrogram amplitudes obtained in patients using the previous lead model 0062.     

The Measurement of the Paced Depolarization Integral Using the Braided Endocardial Lead

Previous studies have shown that the paced depolarization integral (PDI) data recorded in unipolar configuration could potentially improve the specificity of tachyarrhythmia classification in an implantable cardioverter defibrillator (ICD). However, the defibrillation protection would be compromised if the ICD case were used as an indifferent electrode. Since transvenous defibrillation leads are being investigated to be used with ICDs, this study determined if reliable PDI data could be obtained using the braided endocardial defibrillation lead (BEDL), The results demonstrated that comparable PDI values and PDI changes with epinephrine induced sinus tachycardia were obtained with all three tested sensing configurations: conventional unipolar, tip electrode to right ventricular defibrillation electrode, and tip electrode to superior vena cava defibrillation electrode. Therefore, the BEDL can be used to measure PDI data, which possibly may improve tachyarrhythmia classification in an ICD, without compromising its defibrillation protection.     

Initial Experience with Transvenous Implantable Cardioverter Defibrillator Lead Systems: Operative Morbidity and Mortality

Introduction of non-thoracotomy lead systems™ (Medtronic, Inc.) for the implantable cardioverter defibrillator (ICD) has expanded the indications for use of this mode of therapy. Patients previously considered "too ill" to undergo a thoracotomy as well as patients who are at a high risk for developing sudden death but without previous cardiac arrest, are now considered candidates. The initial experience with the non-thoracotomy lead system at our institution was analyzed for morbidity and mortality. Thirty-four patients underwent attempted intravascular lead implantation, with 30 having initial successful implantation (88.2%). There were 23 males; average ejection fraction (EF) was 38.6%. Three patients developed pulmonary edema and low output immediately after the procedure. Three patients developed electromechanical dissociation during defibrillation threshold testing. A prolonged testing time for the non-thoracotomy lead system was noted when compared to the thoracotomy system (57.39 vs 32.30 min; P < 0.0000). There were more intraoperative morbidities with the non-thoracotomy leads than with the thoracotomy system. There were no perioperative deaths. The potential consequences of prolonged anesthesia time and extensive defibrillation threshold testing should be considered when choosing the route of ICD implant, the type of anesthesia, and the intraoperative testing protocol for each patient.     

Epicardial and Nonthoracotomy Defibrillation Lead Systems Combined with a Cardioverter Defibrillator

The intraoperative and long-term results were reviewed in 67 patients who underwent implantation of the Ventritex Cadence defibrillator with either epicardial patch (EPI, 25 patients) or nonthoracotomy CPI Endotak (ENDO, 42 patients) defibrillation lead systems. In the ENDO group, 35 patients (83 %) had a defibrillation threshold (DFT) of ≤ 20 joules and did not require a subcutaneous patch. Intraoperatively, the DFT was 13 ± 9 joules (mean ± SD) for EPI and 15 ± 8 joules for ENDO (P = NS). There was no perioperative death in either group. During a mean follow-up of 12 ± 8 months, there was no sudden death, and four patients died from congestive heart failure (3 EPI, 1 ENDO). During follow-up, 875 spontaneous arrhythmia episodes (AE) occurred in 15 of 25 EPI patients (60%). versus 652 in 28 of 42 ENDO patients (67%; P = NS). Ventricular tachycardia at a rate ≥ 222 beats/min or ventricular fibrillation represented 167 AE for EPI (19%) and 182 AE for ENDO (28%), and was terminated by the first shock in 76% and 75% of attempts, respectively. Ventricular tachycardia at a rate ≥ 222 beats/min represented a total of 1,178 AE and antitachycardia pacing was successful in 660 of 708 AE (93%) with EPI and 414 of 470 AE (88%) with ENDO lead systems (P= NS). Therefore, a nonthoracotomy approach using the Cadence V-100 is safe and effective and has clinical results that are not significantly different from epicardial defibrillation lead systems.     

Instantaneous Lead Entrapment: An Unusual Complication of Nonthoracotomy Implantation of an Endocardial Defibrillation Lead

Nonthoracotomy implantation of implantable cardioverter defibrillators is performed with transvsnous leads that are similar to pacemaker leads and are subject to the same potential problems. We report an unusual complication of lead placement in which an electrode immediately became entrapped in the superior rim of the tricuspid valve, resisting all efforts at removal.     

Inadvertent Implantation of an ICD Lead in the Great Cardiac Vein

We report an implantable cardioverter defibrillator (ICD) implanted with a single lead inadvertently introduced in the great cardiac vein. No venous lesion was caused by the shocks and the position of the lead remained stable. This case emphasizes the usefulness of different fluoroscopic views during ICD implantation.     

Low Incidence of Lead Related Complications Associated with Nonthoracotomy Implantable Cardioverter Defibrillator Systems

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.     

Short-and Long-Term Performance of a Tripolar Down-Sized Single Lead for Implantable Cardioverter Defibrillator Treatment: A Randomized Prospective European Multicenter Study

A new, thinner (10 Fr) and more flexible, single-pass transvenous endocardial ICD lead, Endotak DSP, was compared with a conventional lead, Endotak C, as a control in a prospective randomized multicenter study in combination with a nonactive can ICD. A total of 123 patients were enrolled, 55 of whom received a down-sized DSP lead. Lead-alone configuration was successfully implanted in 95% of the DSP patients vs 88% in the control group. The mean defibrillation threshold (DFT) was determined by means of a step-down protocol, and was identical in the two groups, 10.5 ± 4.8 J in the DSP group versus 10.5 ± 4.8 J in the control group. At implantation, the DSP mean pacing threshold was lower, 0.51 ± 0.18 V versus 0.62 ± 0.35 V (p < 0.05) in the control group, and the mean pacing impedance higher, 594 ± 110 Ω vs 523 ± 135 Ω (p < 0.05). During the follow-up period, the statistically significant difference in thresholds disappeared, while the difference in impedance remained. Tachyarrhythmia treatment by shock or antitachycardia pacing (ATP) was delivered in 53% and 41%, respectively, of the patients with a 100% success rate. In the DSP group, all 28 episodes of polymorphic ventricular tachycardia or ventricular fibrillation were converted by the first shock as compared to 57 of 69 episodes (83%) in the control group (p < 0.05). Monomorphic ventricular tachycardias were terminated by ATP alone in 96% versus 94%. Lead related problems were minor and observed in 5% and 7%, respectively. In summary, both leads were safe and efficacious in the detection and treatment of ventricular tachyarrhythmias. There were no differences between the DSP and control groups regarding short- or long-term lead related complications.     

Resolution of High Initial Epicardial Patch Defibrillation Thresholds Following Chronic Implantation

To determine what effect chronic implantation of automatic implantable car-dioverter defibrillator epicardial patch electrodes had on initial high defibrillation thresholds at implant, six patients were studied. There were five men, one woman, mean age 61 years. Three had coronary artery disease and three had dilated cardiomyopathies. Mean ejection fraction was 20%. Two patients underwent concomitant coronary artery revascularization and one underwent mitral valve replacement. No patient was on antiarrhythmic drugs. At the time of initial implant, adequate defibrillating thresholds could not be obtained in any patch configuration despite the use of up to 40 joules. Further testing was precluded in each patient due to the development of profound hypotension ( 70 mmHg systolic) that was poorly responsive to pressors. The patch electrodes were then implanted in an arbitrary anterior-posterior position and the leads were tunneled to an abdominal pocket. After 10–15 days (mean 11), the lead ends were exposed and defibrillation testing was performed again. In all six patients, adequate defibrillation thresholds were obtained (mean 18 joules). We conclude that if adequate defibrillation thresholds cannot be obtained at implant and if further testing cannot be performed without jeopardizing the life of the patient, the patch electrodes should be implanted and retesting performed at 10–15 days.     

ICD Leads:

GRADAUS, R., et al .: ICD Leads: Design and Chronic Dysfunctions. The treatment of ventricular tachyarrhythmias has changed over the last 10 years. Implantable cardioverter defibrillators (ICDs), once used only as a last resort therapy, have now become the treatment of choice. This change occurred before the first results of randomized studies on ICD therapy in patients with life-threatening ventricular tachyarrhythmias were published by the end of 1997. Technological advances of ICD therapy, in particular the development of transvenous leads, were to a large extent responsible for this change. Modern leads are characterized by their multilumen design that incorporates straight wires and coiled conductors into a single electrode body. Conductors and insulation are sheathed with additional insulation layers. The most frequently used insulating materials are silicone, polyurethane, and fluoropolymers. Lead failures are an important complication of ICD therapy. Fractured conductors, compression, creeping, or insulation defects from abrasion can cause such lead dysfunctions. Chronically implanted leads will inevitably have an increased risk of failure due to defects despite all technological advances. In the light of improving survival figures in patients with ventricular tachyarrhythmias and increasing numbers of ICD implantations, lead failures are becoming a clinical problem of ever increasing importance. Therefore, the question of which lead types necessitate extraction when a certain failure occurs and which leads can be left in place. Despite continuous improvements in lead extraction systems and growing experience in their use, the extraction of any pacemaker or ICD lead is associated with some risk of complications. (PACE 2003; 26[Pt. I]:649–657)     

Subpectoral Implantation of ICD Generators: Long-Term Follow-Up

A nonthoracotomy surgical approach using an endocardial electrode and combined implantation of a subcutaneous patch and the implantable cardioverter defibrillator (ICD) generator in a Subpectoral pocket has been described. We report the long-term follow-up results in patients undergoing implantation using this approach. The patient population consisted of 28 patients (22 men and 6 women) with a mean age of 59 ± 12 years. The underlying heart disease consisted of coronary artery disease in 20 patients and dilated cardiomyopathy in 8 patients. Sustained ventricular tachycardia was the mode of presentation in 16 patients and sudden cardiac death in 12 patients. The mean left ventricular ejection fraction was 31%± 6%. The lead system consisted of an 8 French bipolar passive fixation rate sensing lead positioned at the right ventricular apex, an 11 French spring coil electrode positioned at the superior vena cava-right atrial junction (surface area 700 mm²), and submuscular placement of a large patch (surface area 28 cm²) on the anterolateral chest wall near the cardiac apex via a submammary incision. A defibrillation threshold of ≤ 15 joules (J) was required for implantation. This criterion was not satisfied in five patients; thus, a limited thoracotomy was performed via the submammary incision, and the large patch was placed epicardially. The mean R wave amplitude was 12 ± 3 mV, the mean pacing threshold was 1.0 ± 0.5 V at 0.5 msec, and the mean defibrillation threshold was 12.6 ± 3 J. ICD generators implanted were the Ventak-P in 17, PCD-7217 in 5, and the Cadence V-l00 in 6 patients. These patients have been followed for a mean of 14.6 ± 6 months. There was no perioperative mortality, and none of the patients developed an infection during follow-up. Generator migration or significant discomfort requiring ICD repositioning was not observed, although one patient developed an erosion requiring surgical repair.Conclusions: Subpectoral implantation of the ICD generator is feasible and was well tolerated by all patients with an acceptable complication rate (3.5%). As the size of future generation ICDs is reduced, subpectoral implantation may become the preferred approach.     

Ultrastructural Alterations in the Right and Left Ventricular Myocardium Following Multiple Low Energy Endocardial Countershocks in Anesthetized Dogs

Both high energy transthoracic and direct epicardial defibrillation can result in RV and LV myocardial damage, but little is known about the damage due to defibrillation using an endocardial RV electrode. Furthermore, disturbances in postdefibrillation oxidative metabolism have been reported and may be caused by primary injury of mitochondrial integrity and function, but information about ultrastructural mitochondrial alterations is rare. We therefore studied, in 13 fox hounds, RV and LV ultrastructural alterations following multiple low energy endocardial countershocks. Using an ICD and an endocardial defibrillation system a median of 54 (43–74) countershocks with a cumulative energy of 1,558 J (844–2,141 J) was delivered. After termination of countershocks, RV and LV myocardium was examined by electron microscopy. In both ventricles, severe myocardial alterations were found, including swollen mitochondria, disruption of mitochondrial crests, and loss of integrity of the mitochondrial inner and outer membranes. At the first time a semiquantitative score, originally developed for postischemic injury, was successfully used to grade the postcountershock mitochondrial alteration, which showed a more pronounced damage in the RV (2.69 ± 0.22 points) compared to the LV (2.18 ± 0.22; P = 0.021). We conclude that even the use of endocardial lead systems with low energy countershocks may lead to severe mitochondrial damage, especially in the RV.     

Endocardial defibrillation lead extraction: an unusual case of entrapment

Spurious discharges due to late insulation break in an IS-1 pacing/sensing connector prompted ICD lead removal in 65-year-old man. The tip of the lead was easily freed and pulled back into the SVC by the superior approach. After that, the lead became trapped. The distal part of the lead was caught and easily withdrawn by inferior approach. Superior venous angiography showed extravascular location of the entrapped part of the lead due to the unintentional percutaneous puncture of the innominate vein after piercing the subclavian vein. It may be desirable to use contrast venography before intervention of extraction to ensure venous patency and lead location.     

Improved Sensing Signals After Endocardial Defibrillation with a Redesigned Integrated Sense Pace Defibrillation Lead

Adequate sensing is a basic requirement for appropriate therapy with ICDs. Integrated sense pace defibrillation leads, which facilitate ICD implantation, show a close proximity of sensing and defibrillation electrodes that might affect the sensing signal amplitude by the high currents of internal defibrillation. In 99 patients, we retrospectively examined two integrated sense pace defibrillation leads, eitherboth with a distance of 6 mm between the tip of the lead (sensing cathode) and the right ventricular defibrillation electrode (sensing anode) or one with a distance of 12 mm. Three seconds after a shock of 20 J, mean sensing signal amplitude during sinus rhythm (SR) decreased from 10.5 ± 4.3 mVto 5.1 ± 3.7 mV (P < 0.001) for the 6-mm lead, but showed no significant decrease for the 12-mm lead. The degree of signal reduction was inversely related to the time passed since defibrillation. Significant differences in reduction of sensing signal amplitude concerning monophasic and biphasic shocks could not be observed. Mean sensing signal amplitude of VF after shocks that failed to terminate it decreased in the same order as during SR (from 8.3 ± 4.1 mV to 4.1 ± 3.2 mV), but resulted in no failure of redetection during ongoing VF. DFTs did not differ for the 6-mm and the 12-mm lead. In conclusion, close proximity of the right ventricular defibrillation coil to the sensing tip of an integrated sense pace defibrillation lead causes energy and time related reductions in sensing signal amplitude after defibrillation, and might cause undersensing in the postshock period. A new lead design with a more proximal position of the right ventricular defibrillation coil avoids these problems without impairing DFTs.     

Prospective Randomized Comparison of the Safety and Effectiveness of Placement of Endocardial Pacemaker and Defibrillator Leads Using the Extrathoracic Subclavian Vein Guided by Contrast Venography Versus the Cephalic Approach

CALKINS, H., et al. : Prospective Randomized Comparison of the Safety and Effectiveness of Placement of Endocardial Pacemaker and Defibrillator Leads Using the Extrathoracic Subclavian Vein Guided by Contrast Venography Versus the Cephalic Approach. The purpose of this prospective randomized study was to compare the safety and efficacy of the cephalic approach versus a contrast-guided extrathoracic approach for placement of endocardial leads. Despite an increased incidence of lead fracture, the intrathoracic subclavian approach remains the dominant approach for placement of pacemaker and implantable defibrillator leads. Although this complication can be prevented by lead placement in the cephalic vein or by lead placement in the extrathoracic subclavian or axillary vein, these approaches have not gained acceptance. A total of 200 patients were randomized to undergo placement of pacemaker or implantable defibrillator leads via the contrast-guided extrathoracic subclavian vein approach or the cephalic approach. Lead placement was accomplished in 99 of the 100 patients randomized to the extrathoracic subclavian vein approach as compared to 64 of 100 patients using the cephalic approach. In addition to a higher initial success rate, the extrathoracic subclavian vein medial approach was determined to be preferable as evidenced by a shorter procedure time and less blood loss. There was no difference in the incidence of complications. In conclusion, these results demonstrate that lead placement in the extrathoracic subclavian vein guided by contrast venography is effective and safe. It was also associated with no increased risk of complications as compared with the cephalic approach. These findings suggest that the contrast-guided approach to the extrathoracic portion of the subclavian vein should be considered as an alternative to the cephalic approach.     

Removal of Endocardial Defibrillation Leads

Two patients, each with an endocardial defibrillation lead system (Endotak O62), required lead removal; one because of chronic lead infection and the second because of spurious shocks caused by lead insulation damage. Neither lead could be removed by simple traction. The defective lead was removed by a combination of catheterization techniques including a steerable ablation catheter and traction, both under general anesthesia. The lead with the insulation defect was rapidly removed with a locking stylet, suggesting that endocardial lead defibrillating leads can be removed similarly to pacemaker leads, thus avoid thoracotomy.     

Multiple ICD Discharges Associated with Lead Fracture Without Triggering of High Impedance Alert

The Sprint Fidelis^® lead has an increased incidence of lead fracture. The manufacturer has recommended programming alerts to preempt lead malfunction due to fracture. The current trigger for an alert is an increase in the right ventricular pacing impedance to greater than 1,000 Ω. Our patient suffered multiple inappropriate implantable cardioverter defibrillator therapies with stable impedance less than 1,000 Ω. This case of lead fracture would not have been detected with these programming alerts. Additional programming measures may detect lead fractures, including changing the lower detection for impedances, arranging for a percentage change in the impedance trend to trigger an alarm, or programming the device to warn if there is an increase in nonphysiologic short R-R interval counts.     

Asymptomatic anterior perforation of an ICD lead into subcutaneous tissues

A 71-year-old woman underwent routine implantable cardioverter defibrillator implantation. On a predischarge check the next day, electrical signals and thresholds were excellent and similar to those at implant. The chest X-ray was unremarkable and showed good lead position at the right ventricular apex (RVA). At a routine one-month postimplant visit, electrograms were found to be miniscule, and pacing could not be achieved. Chest X-ray and fluoroscopy suggested perforation, then this was confirmed by computed tomography scan. The tip of the lead was estimated to be within 7 mm of the surface of the skin. The system was removed surgically, and the patient continued to do well.     

Comparison of a Unipolar Defibrillation System with a Dual Lead System Using an Enlarged Defibrillation Anode

The unipolar system for transvenous defibrillation, consisting of a single right ventricular lead as the cathode and the device shell as anode, has been shown to combine low de- fibrillation thresholds (DFTs) and simple implantation techniques. We compared the defibrillation efficacy of this system with the defibrillation efficacy of a dual lead system with a 12-cm long defibrillation anode placed in the left subclavian vein. The data of 38 consecutive patients were retrospectively analyzed. The implantation of an active can system was attempted in 20 patients (group 1), and of the dual lead system in 18 patients (group 2). Both groups had comparable demographic data, cardiac disease, ventricular function, or clinical arrhythmia. The criterion for successful implantation was a DFT of > 24 J. This criterion was met in all 18 patients of group 2, The active can system could not be inserted in 3 of the 20 group 1 patients because of a DFT > 24 J. In these patients, the implantation of one (n = 2) or two (n = 1) additional transvenous leads was necessary to achieve a DFT ≤ 24). The DFTs of the 17 successfully implanted group 1 patients were not significantly different from the 18 patients in group 2 (12.3 ± 5.7 f vs 10.8 ± 4.8 J). The defibrillation impedance was similar in both groups (50.1 ± 6.1 ± 48.9 ± 5.2 Ω). In group 1, both operation duration (66.8 ± 17 min vs 80.8 ± 11 min; P < 0.05) and fluoroscopy time (3.3 ± 2.1 min vs 5.7 ± 2.9 min; P < 0,05) were significantly shorter. Thus, the active can system allows reliable transvenous defibrillation and a marked reduction of operation duration and fluoroscopy time. The dual lead system, with an increased surface area defibrillation anode, seems to he a promising alternative for active can failures.