Evaluation of Outpatients Experiencing Implantable Cardioverter Defibrillator Shocks Associated with Minimal Symptoms

Patients receiving minimally symptomatic shocks from their implantable cardioverter defibrillators were studied prospectively using transtelephonic ECC loop monitoring. The time course to the first subsequent shock was evaluated. Twenty-nine consecutive patients who received a shock preceded by mild palpitations or no symptoms were given a transtelephonic ECG loop monitor and instructed to activate the monitor if a subsequent shock occurred. Kaplan-Meier analysis was used to quantitate the time to first shock during the study period. The point estimate ± standard error of patients receiving a shock during the study period was 31%± 9% at 30 days, 41%± 9% at 60 days, and 60%± 9% at 120 days. The ECG was successfully transmitted in 7 of 13 patients who had shocks in the 60-day monitoring period, and demonstrated inappropriate shocks in 6 of 7. Determination of the cause of shock led to a change in subsequent management in all 7 patients. We conclude that the incidence of inappropriate shocks may be higher than estimated previously in patients with minimal symptoms prior to the shock. There are thousands of patients with implantable cardioverter defibrillators that have no storage function for treated tachycardias; transtelephonic ECG loop monitoring can determine the cause of implantable cardioverter defibrillator discharge in these patients, and the diagnosis is invaluable in their management.     

Clinical Significance of Consecutive Shocks in Patients with Left Ventricular Dysfunction Treated with Implantable Cardioverter Defibrillators

The purpose of the present study was to determine the clinical significance of consecutive automatic shocks delivered by implantable cardioverter defibrillators (ICDs). Sixty-four patients who received ICDs at our institution between January 1990 and July 1997 were included in this study. There were 53 men and 11 women with a mean age of 50 ± 14 years. During a follow-up period ranging between 0.2 and 73 months (mean 23 ± 21 months), 17 patients received consecutive shocks (group A), 29 patients received single shocks (group B), and 18 patients received no ICD therapy (group C). Clinical characteristics, episodes of ICD therapy, and prognosis were compared among the three groups. There were no significant differences among the three groups with regard to clinical characteristics, time to first ICD therapy, number of antitachycardia pacing episodes, or frequency of inappropriate discharges. The mortality rate was higher in group A than in groups B and C (P = 0.0021). The sensitivity of consecutive shocks in predicting death was 70%, the specificity was 88%, and the predictive accuracy was 81% in patients with left ventricular ejection fractions < 35%. In summary, consecutive shocks are a clinically important event in patients with ICDs. Specifically, patients who receive consecutive shocks and have a depressed left ventricular function should be considered particularly high risk.     

Implantation of Pacemakers and Implantable Cardioverter Defibrillators in Orally Anticoagulated Patients

AL-KHADRA, A.S.: Implantation of Pacemakers and Implantable Cardioverter Defibrillators in Orally Anticoagulated Patients. The safety of pacemaker and defibrillator implantations in orally anticoagulated patients using standard techniques has not been thoroughly evaluated. This article describes a prospectively collected experience in such patients. Patients presenting for device implantation who were treated with warfarin were allowed to continue therapy provided that the INR was <3.5. Implantations involved cannulation of the left axillary vein. Except for defibrillator leads, 7 Fr introducers were used, and all were leads actively fixated. The study included 47 patients who underwent implantation of permanent pacemakers (n = 39), defibrillators (n = 5), or biventricular pacemakers (n = 3). The mean INR was 2.3. The primary indication for anticoagulation was a mechanical cardiac prosthesis in 11 (24%) patients. Atrial fibrillation was present in 33 patients. There were no instances of major bleeding or hematomas requiring evacuation. One patient had a small soft hematoma, which resolved spontaneously. At 6 weeks, all patients had well-healed scars with satisfactory pacing and sensing thresholds. In experienced centers, patients requiring treatment with warfarin may undergo implantation of pacemakers or defibrillators with minimal risk despite continuation of anticoagulation. (PACE 2003; 26[Pt. II]:511–514)     

Implantation of Submammary Implantable Cardioverter Defibrillators

Implantable cardioverter defibrillators (ICDs) are routinely placed in the left pectoral area using a transvenous approach. This approach may result in poor cosmetic outcome and cause psychological problems, especially in younger patients. To avoid this, several alternative implantation techniques have been developed. For cosmetic reasons, we used a submammary technique to implant ICDs into three young women. Apart from defibrillation threshold testing, the procedures were performed under local anesthesia. Threshold testing was done under general anesthesia. Appropriate defibrillation thresholds were obtained in all three cases, and all the patients tolerated the procedure well. There were no complications in a mean of 22 months of follow-up, and the cosmetic results were very good.(PACE 2004; 27[Pt. I]:779–782)     

Remote Monitoring of Implantable Cardioverter Defibrillators:

A prospective study evaluating the functionality and ease of use of the Medtronic CareLink^® Network, "CareLink," was conducted at ten investigational sites. This internet-based remote monitoring service allows clinicians to remotely manage their patients' implantable cardioverter defibrillators (ICDs) and chronic diseases. The network is comprised of a patient monitor, a secure server, and clinician and patient websites. Under clinician direction, patients interrogated their ICDs at home, and transmitted data to secure servers via a standard telephone line. Comprehensive device data and a 10-second presenting rhythm electrogram were captured by the monitor and available for access and review on the clinician website. The information could also be printed using a standard desktop computer with internet access. During this study, patients were asked to transmit device data twice, at least 7 days apart, as scheduled by the clinic. Monitor functionality was assessed, and ease of using the system components was evaluated via questionnaires completed by patients and clinicians following each data transmission and review. Fifty-nine patients (64 ± 14 years, range 22-85 years) completed 119 transmissions with only 14 calls to the study support center. Clinician review of data transmissions revealed several clinically significant findings, including silent AF discovery, assessment of antiarrhythmic drug efficacy in a previously diagnosed AF patient, previously unobserved atrial undersensing, and ventricular tachycardia. ICD patients found the monitor easy to use. Clinicians were pleased with the performance of the network and the quality of the web-accessed data, and found it comparable to an in-office device interrogation. CareLink is a practical tool for routine device management and may allow timely identification of clinically important issues. (PACE 2004; 27[Pt. I]:757–763)     

Implantable Cardioverter Defibrillators in Patients with Chagas' Disease: Are They Different from Patients with Coronary Disease?

Chagas' disease is a parasitic affliction, endemic to certain regions of South America, which may lead to a chronic dilated nonischemic cardiomyopathy. Ten Chagasic patients were compared to 18 coronary patients undergoing transvenous ICD implantation for ventricular tachycardia (VT), ventricular fibrillation (VF), or aborted cardiac arrest. Indications for ICD implantation were either drug intolerance or refractoriness, or no inducible tachyarrhythmia at EPS. There were no statistically significant differences between the Chagas and coronary artery disease groups with respect to age (60.2 vs 62.6 yrs], NYHA Class II (50% vs 62%), ejection fraction (31.1% vs 29.7%), and incidence of cardiac arrest (20% vs 33%), respectively. The following ICD implant and long-term follow-up variables were compared between the two groups: pacing threshold (0.94 V vs 0.95V), defibrillation threshold (19.5 J vs 19.6 J), number of VT episodes (414 vs 435), number of spontaneous VT terminations (86 vs 187), percent efficacy of antitachycardia pacing (93.9% vs 92.1 %), and total number of shocks (112 vs 145). These differences were not statistically significant. We conclude that patients with Chagas' disease, compared with coronary artery disease patients, have similar clinical characteristics leading to ICD implantation. Furthermore, no differences were found with respect to ICD and long-term follow-up characteristics between the two groups.     

Implantable Defibrillator Diagnostic Storage Capabilities: Evolution, Current Status, and Future Utilization

There has been a rapid and significant evolution in the stored diagnostic information available from implantable cardioverter defibrillatars (ICDs). The diagnostic information available in current generation ICDs has greatly enhanced the clinicians' ability to determine the rhythm triggering device therapy as well as to identify potential problems with the ICD system. Furthermore, this information may be useful in identifying triggers of ventricular arrhythmias in patients at high risk for sudden death. The history, evolution, value, and limitations of the stored diagnostic capabilities of implantable defibrillators are discussed.     

Safety of Pacemaker Implantation in Patients with Transvenous (Nonthoracotomy) Implantable Cardioverter Defibrillators

While several reports bave documented the safety of implantation of transvenous pacemakers in patients with epicardial patch-based impiantable cardioverter defibrillators (ICDs), the implantation of transvenous pacemakers in patients with transvenous (nonthoracotomy) ICDs has not been well-descrihed. We present three patients with transvenous ICDs who subsequently underwent implantation of transvenous pacemakers without complication. Technical considerations and a testing protocol for detection of pacemaker-ICD interactions are discussed.     

The Potential Usage of Dual Chamber Pacing in Patients with Implantable Cardioverter Defibrillators

Bradycardia support by ICDs has been limited to fixed rate, ventricular pacing. Concomitant placement of a pacemaker and an ICD exposes a patient to potentially life-threatening device interactions. ICDs capable of dual chamber pacing have recently become available. The number of ICD recipients who stand to benefit from the addition of dual chamber pacing is debated, but no data have addressed this question. This retrospective study analyzed all patients who received nonthoractomy ICD system placement at the Mayo Clinic in Rochester, MN between March 1991 and October 1996 in order to determine the proportion of patients in whom a dual chamber pacing ICD may be indicated. Definitions: (1) Definitely indicated = pacemaker present at ICD implant or NASPE Class I pacing indication; (2) Probably indicated = NASPE Class II pacing indication, NYHA Functional Class III or IV, or history of systolic congestive heart failure; (3) Possibly indicated = history of paroxysmal atrial fibrillation or an ejection fraction ≤ 20%. The results were that nonthoracotomy ICDs were placed in 253 patients. A dual chamber ICD would have been definitely indicated in 11% of the study group, probably indicated in 28%, and possibly indicated in 14%. Chronic atrial fibrillation was present at ICD implant in 6.7% of patients and developed in 0.9%/yr during follow-up. The addition of dual chamber pacing to ICDs stands to potentially benefit approximately half (53%) of ICD recipients. These data do not address all patients who may benefit from dual chamber sensing.     

Predictors of Psychosocial Adjustment in Patients with Implantable Cardioverter Defibrillators

Predictors of psychological distress/adjustment were examined in 25 patients following placement of ICDs. Patients completed a demographic questionnaire and a standardized questionnaire of psychological symptoms (i.e., Symptom Checklist-90 Revised; SCL-90-R). The number of discharges categorized by the patient as inappropriate and appropriate were also ascertained. The number of ICD discharges categorized as inappropriate and diminished levels of physical activity (r = 0.53 and 0.63, P < 0.01, respectively) did significantly relate to overall psychological distress. In addition, after controlling for age and prior psychiatric and physical health status through a stepwise multiple regression analysis, the occurrence of ICD discharges categorized as inappropriate and diminished physical activity continued to significantly predict overall psychological distress (R²= 0.41, P < 0.01). However, the number of ICD discharges categorized as appropriate did not significantly predict overall psychological distress. The results of this investigation suggest that further refinement of the ICD could reduce the risk of exposure to potential psychological distress, and an analysis of prior and anticipated patient physical activity levels should be a factor when calibrating minimum ICD discharge threshold levels.     

Transvenous Atrial Cardioversion Threshold in Patients with Implantable Cardioverter Defibrillator: Influence of Active Pectoral Can

Recent studies have shown that transvenous atrial cardioversion is feasible with lead configurations primarily designed for implantable cardioverter defibrillators (ICD). The purpose of this study was to examine the influence of an active pectoral ICD can on the atrial cardioversion threshold (ADFT). Forty consecutive patients received a transvenous single lead system (Endotak DSP 0125, CPI, St. Paul, MN, USA) in combination with a left subpectoral ICD (Ventak Mini, CPI) for treatment of malignant ventricular tachyarrhythmias. Patients were randomized into two groups: 21 received a Hot Can 1743 and 19 patients a Cold Can 1741. Step-down testing of the ventricular defibrillation threshold (VDFT) was performed intraoperatively and evaluation of the ADFT for induced atrial fibrillation (AF) at predischarge. After testing, each patient received a 2-J shock and was asked to quantify discomfort on a numerical scale ranging from 0 to 10. Both groups were comparable with regard to all clinical parameters studied. The mean VDFT in patients with a Hot Can device was significantly lower than in patients with a Cold Can (7.5 ± 2.3 J vs 9.8 ± 3.8 J; P < 0.03). The mean ADFT in the Hot Can group tended to be lower than in the group with Cold Cans (3.4 ± 1.4 J vs 4.5 ± 2.4 J; P = 0.07), and the proportion of patients in whom atrial cardioversion was accomplished at low energies (≤ 3 J) was higher in patients with active compared with patients with inactive pulse generators (57% vs 26%; P < 0.04). The mean discomfort reported after delivery of a 2-J shock was comparable in both groups (Hot Can 5.2 ± 1.9; Cold Can: 5.3 ± 2.1; P = NS). We conclude that the inclusion of an active left subpectoral can in the defibrillation vector of a ventricular ICD seems to reduce the energy requirements for atrial cardioversion without increasing the discomfort caused by low energy shocks.     

Failure of Third-Generation Implantable Cardioverter Defibrillators to Abort Shock Therapy for onsustained Ventricular Tachycardia Due to Shortcomings of the VF Confirmation Algorithm

Unnecessary shocks by ICDs for rhythms other than sustained VT or VF have been described as the most frequent adverse event in ICD patients. To avoid unnecessary shocks for self-terminating arrhythmias, the third-generation Jewel PCD defibrillators 7202, 7219, and 7220 Plus use a specially designed VF confirmation algorithm after charge end. The purpose of this study was to determine the ability of this VF confirmation algorithm to recognize nonsustained VT, and to analyze the reasons for failure of the PCD device to abort shock therapy for nonsustained VT despite use of this VF confirmation algorithm. Analysis of stored electrograms of electrical events triggering high voltage capacitor charging in the programmed VF zone of the device showed 36 spontaneous episodes of nonsustained VT (227 ± 21 beats/mm) during 18 ± 7 months follow-up in 15 patients who had a Jewel PCD implanted at our hospital. Intracardiac electrogram recordings and simultaneously retrieved marker channels demonstrated that the ICD shock was appropriately aborted according to the VF confirmation algorithm in 24 (67%) of 36 episodes of nonsustained VT. Twelve episodes (33%) of nonsustained VT, however, were followed by a spontaneous ICD shock in 6 (40%) of the 15 study patients. The only reason for all 12 shocks for nonsustained VT was the inability of the device to recognize the absence of VT after charge end due to shortcomings of the VF confirmation algorithm: 11 of the 12 shocks for nonsustained VT were triggered by the occurrence of paced beats during the VF confirmation period and 1 shock for nonsustained VT was triggered by the occurrence of 2 premature beats after charge end. Thus, better VF confirmation algorithms need to be incorporated in future PCD devices to avoid unnecessary shocks for nonsustained VT.     

A Fuzzy Logic-Controlled Classifier for Use in Implantable Cardioverter Defibrillators

Purpose: Implantable cardioverters defibrillators (ICDs) are increasingly used in the management of life-threatening arrhythmias. Correct recognition of a treatable arrhythmia is crucial to this application. However, the computational power of microprocessors currently used in ICDs limits the range of traditional algorithms available for this application. Methods: Classification based on fuzzy inference systems (FIS) were trained to recognize different cardiac rhythms (AF, VF, SVT, VT) from the Ann Arbor Electrogram Library. The FIS used were designed using adaptive-network-based fuzzy inference methods to optimize the classification procedure. Only computational techniques suitable for ICD design were used. Results: After pretraining with the ANFIS correct rhythm classification was observed for the rhythms studied. Conclusion: In this preliminary study, successful rhythm classification was demonstrated using fuzzy logic techniques. In view of the computational efficiency this may have application in ICD design.     

Multiple Inappropriate Shocks Precipitated by Interrogation of an Implantable Cardioverter Defibrillator

A 57-year-old man suffered multiple inappropriate shocks from an implantable cardioverter defibrillator that could not be inactivated because the magnet switch feature was deactivated. Attempts to interrogate the defibrillator caused shocks to be delivered. Emergent explantation was performed and a loose sensing lead was discovered. Sensing and defibrillation leads functioned normally, and testing of the explanted generator demonstrated no abnormalities. A new generator was put in place and the patient has been without shocks for 6 months. This case illustrates the need for robust methods of attenuating electromagnetic interference and the importance of multiple methods of device inactivation.     

Infections in Implantable Cardioverter Defibrillator Patients

Implantable cardioverter de;fibrillators fICDsj have been documented as an effective modality in reducing arrhythmic mortality. A serious complication associated with implantation of the device is infection. Few studies have addressed this issue. Two hundred seven patients with refractory ventricular arrhythmias underwent 207 ICD implantations, and 56 subcutaneous generator changes at our institution. Eight patients developed wound infections, four following ICD implantation (4 out of 207 or 1.9%), and four following a generator change (4 out of 56 or 7.1%). Wound cultures most commonly revealed Staphylococcus aurous and Staphylococcus epidermidis. Infections treated with antibiotics alone, or with only generator removal, frequently recurred (four out of five attempts). There were no recurrences following total patch/lead and generator system removal. In jive patients, the same generator unit was successfully emplaned following ethylene oxide sterilization without infection recurrence. We conclude that treatment of device-associated infection generally requires total generator and patch/lead system removal, and that generator units can be successfully reimplanted yielding substantial cost savings.     

Antitachycardia Pacing in Patients with Implantable Cardioverter Defibrillators: How Many Attempts Are Useful?

The purpose of this study was to determine the termination and acceleration rates for 1 to 6 attempts of antitachycardia pacing (ATP) delivered by ICD in order to terminate spontaneously occurring VTs. Twenty-four ICD recipients with active ATP programs, including a maximum of six ATP sequences and spontaneously occurring VTs during follow-up, were investigated. During a mean follow-up of 42 ± 15 months (range, 17–63 months) 413 spontaneous VT episodes (17 ± 14; range, 1–49 per patient) resulting in appropriate ATP delivery by the ICD occurred. ATP successfully terminated 328 episodes (80 %) with a mean number of 1.6 ± 1.1 pacing sequences. Eighty episodes (19%) were accelerated by ATP and 5 (1%) were unresponsive to ATP. The ATP success decreased until the third ATP sequence (59%→ 31%→ 24%), but increased again in the fourth to sixth attempt (46%→ 46%→ 29%). The acceleration rate increased from sequence one to sequence three (8%→ 13%→ 28%), but decreased significantly in further ATP attempts (19%→ 0%→ 0%). The mean time delays until redetection or termination after 4, 5, and 6 attempts of ATP were 22 ± 5 seconds, 37 ± 2 seconds, and 41 ± 9 seconds, respectively. Nine patients (37%) used ≥3 ATP attempts during follow-up and all of them had a therapeutic benefit from it. Five out of 13 VTs (38%) treated with ≥4 attempts could ultimately be terminated by ATP. The results of this study demonstrate that the first ATP sequence is the most effective and that > 4 ATP attempts may be useful in a minority of patients. There seems to be a low risk of VT acceleration by the fourth to sixth ATP sequence. Because of the associated time delay, a high number of ATP attempts should only be programmed in patients with hemodynamically well-tolerated stable VTs.     

Significant Differences in Charge Times Among Currently Available Implantable Cardioverter Defibrillators

Capacitor charging accounts for most of the delay between arrhythmia detection and therapy delivery in ICDs. Long capacitor charge times may increase the risk of syncope in patients with poorly tolerated arrhythmias. To determine if there are clinically important differences in charge time among currently available devices, we analyzed charge times at various delivered energy levels in three manufacturers'devices: Medtronic, CPI, and Ventritex, Charge times were measured for shocks delivered for spontaneous or induced arrhythmias occurring from time of implant to 4 months after implant. A total of 343 shocks were assessed in 63 patients with ICDs: 16 Medtronic (Microfewel II, model 7223Cx). 14 CPI (Mini II, model 1762), and 33 Ventritex (Cadet and Contour, models V-115 and V-145). The curves of the relationship between charge time and delivered energy for the three types of devices were significantly different, with Medtronic charge times shorter than CPI or Ventritex (P < 0.0001), and CPI charge times shorter than Ventritex (P - 0.002). The difference in mean charge times between the Ventritex and Medtronic devices ranged from 1.7 seconds at a delivered energy of 10 ± 2.5 J to 8,0 seconds at a delivered energy of 30 ± 2.5 J. Thus, clinically important differences in charge time exist among the three types of defibrillators studied. These results should be considered in selecting an ICD for patients with poorly tolerated arrhythmias .