A Pitfall in Using Far-Field Bipolar Electrograms in Arrhythmia Discrimination in a Patient with an Implantable Cardioverter Defibrillator

Analysis of stored electrograms from bipolar far-field electrodes is considered to be useful in differentiating supraventricular from ventricuiar arrhythmias. A case of inappropriate ICD shocks for sinus tachycardia is presented whereby successive shocks caused marked widening of the ventricuiar electrograms. Analysis of these stored electrograms, recorded from far-field bipolar electrodes, gave the false impression of ventricuiar tachycardia. The widening was due to the current of injury effects, probably a consequence of the large amount of intervening myocardium between the bipoies. While analyzing recordings from far-field bipolar electrodes is generally useful, it is not always reliable, for changes in electrogram morphoiogy, reiative to baseline rhythm, may result from other factors like current of injury.     

Complications of Implantable Cardioverter Defibrillator Therapy: Follow-Up of 241 Patients

In order to determine the incidence of complications of impJantable cardioverter defibrillator (ICD) therapy, 241 patients with a total of 353 ICD implantations were followed for 24 ± 20 months. Complications were defined as any untoward effects experienced by the patient related to the ICD implantation and function or death within 4 weeks of implant or before hospital discharge. During follow-up, 129 of 241 patients (53%) had a total of 166 complications. An operative procedure was required to correct the complication in 50 of the 241 patients (21%). No patient died intraoperativeiy, but eight patients died within 4 weeks postoperatively or before hospital discharge. ICD infection required removal of the device in 13 patients (5%). Twenty-six patients (11%) had postoperative respiratory complications. Postoperative bleeding and/or thrombosis occurred in 11 patients (4%). Endocardial lead migration was observed in nine patients (4%) and lead adapter or insulation break occurred in nine patients (4%). Fifty-four patients (22%) experienced ECC-documented discharges for non-VT rhythm. In conclusion, although perioperative mortality in ICD patients is low, the maiority of patients have complications during followup. Recognition of these complications may allow for advances in ICD technology and management strategies to avoid their occurrence.     

Combined Third-Generation Implantable Cardioverter Defibrillator with Permanent Unipolar Pacemakers: Preliminary Observations

As implantable Cardioverter defibrillators (ICDs) are strictly contraindicated in the presence of unipolar pacemakers, currently available options in patients having such chronic pacing systems include: abandoning the implanted pacemaker and selecting an ICD with ventricular demand (VVI) pacing; or replacing the chronic (dual chamber) unipolar pacing system with a dedicated bipolar version prior to ICD implantation. In three patients with previously implanted unipolar pacemakers, we challenged the premise that all ICD systems are incompatible by combining with a third-generation transvenous ICD system (Medtronic 7217B PCD® incorporating true bipolar sensing, a self-limiting auto-adjusting sensitivity, and a tolerant VF detection algorithm. The potential for pace-maker-ICD interaction was minimized by separating the tip of the ICDs transvenous right ventricular pace/sense-defihrillation coil lead from that of the chronic pacemaker lead by > 2–3 cm, and by performing “worst case” intraoperative testing. Although ICD double-counting of the dual chamber pacemaker's atrial and ventricular pacing spikes could be provoked at extreme high output settings, it did not occur at clinically appropriate settings. More importantly, continuous high output asynchronous pacing during ventricular fibrillation (VF) did not interfere with ICD detection. During a mean follow-up period of 18 months, one patient has had VF appropriately terminated bv the ICD. In the remaining two patients, proper VF detection and ICD function was reassessed at 3 months and/or at 1 year during noninvasive testing. Conclusion: These preliminary findings demonstrate that this transvenous ICD system's VF sensing and detection features combined with careful implant technique, rigorous “worst case” testing for possible pacemaker-ICD interaction with regular follow-up, may permit implantation of this ICD system in patients with chronic unipolar pacing systems. Further studies are needed to validate the long-term clinical safety of this promising revised approach to a currently contraindicated device combination.     

Inappropriate Implantable Cardioverter-Defibrillator Therapy Due to the Detection of Premature Ventricular Complexes

Inappropriate shocks delivered by implantable cardioverter-defibrillators may occur in 15%-40% of patients treated with these devices. This article describes a rare cause for inappropriate shocks. Two patients received inappropriate shocks due to the presence of premature ventricular complexes during attempted reconfirmation of ventricular fibrillation. Knowledge of device algorithms for detection and reconfirmation of ventricular fibrillation, designed to have a high degree of sensitivity and therefore lower specificity, allows for reprogramming to avoid further inappropriate shocks.     

Transtelephonic Interrogation of the Implantable Cardioverter Defibrillator

Third generation implantable cardioverter defibrillators (ICDs) have extensive memory capability to store data about the patient's arrhythmias and the effect of therapies delivered by the ICD. However, this data has so far been accessible only when the patient attends the pacing clinic. Two Medtronic 9421 PCD TeletraceR transmitters have been used to interrogate Medtronic 7216A and 7217B PCD S at distances of up to 300 miles from our hospital and transmit the data to a 9420 PCD TeletraceR receiver. Successful transmission of data has been obtained on 50 occasions with 100% data concordance with repeat transmission. The system can reduce the number of unscheduled clinic visits, reduce delay in making a diagnosis following unexpected delivery of a shock therapy, and reassure patients about to be discharged following ICD implantation. The benefits are magnified where patients reside far away from the implanting center.     

Limitations of Tachycardia Confirmation and Rate Classification Algorithms in a Third-Generation Implantable Cardioverter Defibrillator

Newer ICDs provide antitachycardia (ATP) and bradycardia pacing and cardioversion and defibrillaiion shocks based on sensed interval criteria. The objectives of this investigation were to determine the algorithm related errors in tachycardia confirmation and rate classification that occurred in patients with a third-generation, noncommitted, tiered ICD therapy. Forty-three consecutive patients with the Guardian ATP 4210 ICD, which uses an X out of Y sensed interval counting algorithm for tachycardia detection, confirmation, and classification were studied. Surface ECGs, intracardiac electrograms, stored data logs, and sense histories were reviewed to diagnose errors due to these algorithms that resulted in delivery of inappropriate therapy or inhibition of appropriate therapy. Sixty-eight classification or confirmation algorithm errors from 7,610 tachycardia detections (< 1 %) were diagnosed in 23 (53%) of 43 patients. Three types of errors not related to device or sensing lead malfunction or programming mistakes were seen. In 26 episodes, the confirmation algorithm failed to detect late tachycardia reversion of nonsustained tachyarrhythmias, on the last or next to last sensed interval, and did not inhibit ATP (n = 17) or shocks (n = 9). In 28 episodes, inaccurate classification of tachycardia rate resulted in inappropriate ATP (n = 23) or shock (n = 5) therapy. In 14 episodes, the posttherapy reconfirmation algorithm produced inhibition of VVI pacing and prolonged asystole following shock therapy. These errors in tachycardia confirmation and rate classification were due to the inherent limitations of the X out of Y counting algorithm.     

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.     

Modified Magnet Test for a Reversed Automatic Implantable Cardioverter Defibrillator

We present the case of a 55-year-old man with atrial septal defect and cardiomyopathy who underwent implantation of an automatic cardioverter defibrillator (AICD) for ventricular tachycardia resulting in collapse. This case demonstrates multiple unusual complications related to AICD, including rotation of the pulse generator unit about its long axis requiring a "left-handed" magnet test to determine the appropriate counts.     

AutoCapture with Dual-Coil Leads of Implantable Cardioverter Defibrillator

AutoCapture™ (AC) can confirm ventricular capture with true bipolar single coil leads of implantable cardioverter defibrillators (ICD). The compatibility of AC with a new, true bipolar, dual-coil ICD lead needed to be evaluated. This multicenter study enrolled 46 patients (69 ± 10 years, 37 men) undergoing ICD implantation. All patients received a true bipolar, dual-coil lead. Evoked response (ER) sensitivity and AC threshold tests were performed using a pulse generator with the AC algorithm. Mean capture threshold was 0.85 ± 0.67 V, pacing impedance 612 ± 225 Ω, R wave amplitude 13.85 ± 6.17 mV, and defibrillation threshold 14.4 ± 5.1 J. AC was recommended in 45 patients (97.8%) with ER and polarization values of 14.86 ± 7.32 mV and 0.87 ± 0.69 mV, respectively. The AC algorithm was highly compatible with true bipolar, dual-coil ICD leads. An AC algorithm specifically designed for an ICD may improve the generator longevity. Further examination of AC compatibility with other leads is warranted.     

Programmable VT Detection Enhancements in Implantable Cardioverter Defibrillator Therapy

This report describes the distribution of automatically measured values of enhanced arrhythmia detection parameters such as “rate stability” and “rate onset” in various forms of spontaneous arrhythmia episodes in patients treated with a new, third-generation, tiered therapy implantable cardioverter defibrillator (ICD). The study population consisted of 27 patients who received the Ventak PRxII cardioverter defibrillator, which provides extensive diagnostic options such as electrogram storage capabilities, and the ability to store measured values of additional arrhythmia detection parameters such as rate stability and rate onset during spontaneous arrhythmia episodes. During a follow-up period of 11.1 ± 5.2 months, this device detected 264 arrhythmia episodes. The analysis of stored electrograms revealed 13 episodes of sinus tachycardia, 52 episodes of atrial tachyarrhythmias, and 201 episodes of monomorphic ventricular tachycardias (VTs). The mean measured values of rate stability and rate onset were: 2.2 ± 0.9 msec, 0% in sinus tachycardias; 41.0 ± 24.1 msec, 8.5%± 9.5% in atrial tachyarrhythmias; and 7.8 ± 6.0 msec, 30.6%± 12.1% in monomorphic VTs. There was a wide zone of overlapping measured values for rate stability and rate onset in ventricular and nonventricular rhythms. No episode of VT showed a measured rate stability criterion > 35 msec. The subanalysis of arrhythmia episodes presenting with a heart rate < 160 beats/mm revealed no episode of VT with a rate stability value > 24 msec. The calculated, rate dependent specificities for these programmed rate stability parameters in detecting VTs were 46.2% and 81.8%, respectively. The analysis of the rate onset algorithm revealed no comparable relationship between sensitivity and specificity in the detection of VTs. Additional arrhythmia detection algorithms such as rate stability and rate onset may contribute to a significant enhancement in the specificity of lCD therapy.     

The Impact of the Implantable Cardioverter Defibrillator on Quality-of-Life

The implantable Cardioverter defibrillator (ICD) is an established treatment for patients with life-threatening ventricular arrhythmias. While it clearly reduces the incidence of death from recurrent arrhythmia, little is known about the impact on patients' quality-of-life. In this prospective study, quality-of-life was assessed by questionnaire before and after ICD implantation. The "Sickness Impact Profile" (SIP), which evaluates physical, psychosocial, and other activities, as well as functions of daily life, was used. Employment and rehospitalization rates were also examined. Twenty-one of 23 consecutive patients, aged 58 ± 11 years, undergoing ICD implantation at Royal Perth Hospital were studied. During the 14 ± 8 month follow-up, 4 patients died. Functional capacity was unchanged in all but one of the survivors in whom it improved from New York Heart Association Class III to II. Four of 8 survivors employed before implant have since retired. Six patients required rehospitalization on 13 occasions, problems related to arrhythmias or the ICD. Overall SIP scores preimplant (11.2 ± 9.3; P < 0.05) were significantly worse at 6-month follow-up (21.7 ± 18.2), but returned to preimplant levels by 12-month follow-up (8.8 ± 10.8; NS). This was primarily due to transient problems in the areas of emotional behavior, alertness, and social interaction. SIP psychosocial dimension scores: preimplant: 7.2 ± 9.0; 6-month: 17.8 ± 18.1 (P < 0.05); and 12-month: 8.6 ± 10.3 (NS). Early retirement and hospitalizations due to arrhythmias may still be expected even after implantation of an ICD; however, quality-of-life appears only to temporarily decline.     

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.     

Infection of Implantable Cardioverter Defibrillator Systems: A Preventable Complication?

In a consecutive series of 164 patients undergoing primary implantation of an impJantable cardioverter defibrillator (ICD), two patients died in the hospital (1.2%) and early system infection developed in one patient requiring expJantation of the device (0.61%). Late infection developed in one additional patient (0.61%) 7 months after transvenous ICD implantation, and was thought to be due to a recent intravascular catheterization. Symptomatic generator pocket hematomas developed in three patients, two of which were treated by simple evacuation and one with temporary generator explantation and subsequent reimplantation of the unit in a new pocket. No infection developed in these three patients during follow-up. Generator erosion without obvious system infection developed in a fourth patient. Guidelines for the prevention of infection in ICD systems are presented.     

Sudden Death Mortality in Implantable Cardioverter Defibrillator Patients

Implanfable Cardioverter defibrillator (ICD) prevention of sudden cardiac death (SCD) is not absolute and our experience was reviewed to determine the frequency and nature of SCO in this population. The incidence and cause of mortality in 56 consecutive patients, who underwent ICD implantation beginning May 1982 with follow-up through May 19, 1990 were analyzed. Twenty-one patients died, 33% of the mortality was due to SCD, and 52% of deaths may be considered arrhythmic. The cumulative 1, 3, and 5 year SCD survivals were 93%, 89%, and 75%. All seven patients dying of SCD presented initially with SCD, all received previous shocks prior to SCD, and two of the seven patients had devices that were probably inactive at the time of death. We conclude that ICDs reduce but by no means eliminate arrhythmic death, particularly in those at highest risk for SCD. Arrhythmic death remained the most common cause of death in this population.