Primary Prevention Implantation of Cardioverter Defibrillator without Defibrillation Threshold Testing: 2-Year Follow-up

Background: Even though the intraoperative threshold testing of the implantable cardioverter defibrillator ( ICD ) may cause hemodynamic impairment or be unfeasible, it is still considered required standard practice at the time of implantation. We compared the outcome of ICD recipients who underwent defibrillation threshold testing (DFT) with that of patients in whom no testing was performed.
Methods: A total of 291 subjects with ischemic dilated cardiomyopathy received transvenous ICDs between January 2000 and December 2004 in five Italian cardiology centers. In two centers, DFT was routinely performed in 137 patients (81% men; mean age 69 ± 9 years; mean ejection fraction 26 ± 4%) (DFT group), while three centers never performed DFT in 154 patients (90% men; mean age 69 ± 9 years; mean ejection fraction 27 ± 5%) (no-DFT group).
Results: We compared total mortality, total cardiovascular mortality, sudden cardiac death (SCD), and spontaneous episodes of ventricular arrhythmia (sustained ventricular tachycardia, VT, and ventricular fibrillation, VF) between these groups 2 years after implantation (median 23 months, 25th–75th percentile, 12–44 months). On comparing the DFT and no-DFT groups, we found an overall mortality rate of 20% versus 16%, cardiovascular mortality of 13% versus 10%, SCD of 3% versus 0.6%, VT incidence of 8% versus 10%, and VF incidence of 6% versus 4% (no significant difference in any comparison).
Conclusions: No significant differences in the incidence of clinical outcomes considered emerged between no-DFT and DFT groups. These results should be confirmed in larger prospective studies.     

Prehospital Discharge Defibrillation Testing in ICD Recipients: A Prospective Study Based on Cost Analysis

Prehospital discharge defibrillation testing is often performed to verify the function of newly implanted cardioverter defibrillators (ICDs). To determine whether elimination of predischarge testing could reduce costs without placing patients at additional risk, 31 patients were randomized in this prospective clinical evaluation to either receive or not receive a predischarge ICD defibrillation test. Expenses associated with postimplant care was the primary endpoint. All patients underwent induction of ventricular fibrillation after 6 months to evaluate ICD function. The groups were well matched in terms of patient characteristics, initial lead implant parameters, and defibrillation thresholds. Elimination of prehospital discharge testing resulted in a savings of $1,800/patient after 6 months, with no difference between groups in terms of ICD complication rates or unanticipated hospital admissions. Further studies are needed to better define the most appropriate time to assess defibrillation thresholds in the first year after implantation.     

Outcomes of Elderly Recipients of Implantable Cardioverter Defibrillators

Aims of the Study: To examine the patterns of use, complication rates, and survival in elderly recipients of implantable cardioverter defibrillators (ICD).
Methods and Results: We followed 500 consecutive patients included in the Marburg Defibrillator database for 48 ± 39 months. There were 40 patients (8%) ≥75 and 460 (92%) <75 years of age at the time of implant. The 5-year Kaplan-Meier estimate for appropriate treatment of VT or VF by ICD was 49% among patients <75- versus 57% among patients ≥75-years-old (P = 0.17). The 5-year sudden death rate was similarly low in both groups of patients (2% versus 3%). The 5-year overall mortality rate was significantly higher in patients ≥75 than in patients <75 years of age (55% versus 21%, P = 0.001), due to a higher mortality from heart failure (HF). All procedure-related, lead-related, and pulse generator-related complications were similar in both patient groups (23% versus 25%).
Conclusions: ICD therapy was equally effective in patients ≥75 and patients <75 years of age in the prevention of sudden cardiac death. While the complication rates were similar in both age groups, the long-term mortality was considerably higher in elderly patients, due to a higher mortality from HF. The current ICD therapy guidelines appear applicable to elderly patients who are otherwise medically stable and without advanced HF.     

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)     

Clinical Evaluation of the Safety of Repetitive Intraoperative Defibrillation Threshold Testing

One goal of the initial implantation procedure for a cardioverter defibrillator is determination of the configuration and patch location with the lowest defibrillation threshold (DFT). To determine the safety of multiple defibrillation tests, an analysis of the intraoperative defibrillation threshold tests (DFTT) in our patients was performed. In 84 patients, the mean number of DFT trials was 5.27; the mean number of joules received was 275.0. The maximum number of shocks in one implant procedure was 50 for a total of 4,895 joules without complications. Four patients received 30 or more DFT shocks without complication. There were two complications related directly to the DFTT: one patient with severe noninflammatory cardiomyopathy developed electromechanical dissociation and was subsequently resuscitated and survived; the second patient with severe triple vessel coronary artery disease suffered an intraoperative myocardial infarction during testing and eventually died 22 days postoperatively. All patients received an ICD unit; six patients had DFTs of greater than 20 joules. Based on our experience, we followed the clinical status (heart rate, blood pressure, ECG changes, fluid status, total anesthesia time) during the DFTT to determine the extent and duration of our testing protocol. Multiple shocks due to repositioning of the leads in a stable patient should not prohibit extensive testing as adverse consequences do not appear to be cumulative.     

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)     

Defibrillation Threshold Testing in Patients with Hypertrophic Cardiomyopathy

Introduction: Implantable cardioverter‐defibrillators (ICDs) decrease sudden cardiac death in patients with hypertrophic cardiomyopathy (HCM). One of the vital aspects of ICD implantation is the demonstration that the myocardium can be reliably defibrillated, which is defined by the defibrillation threshold (DFT). We hypothesized that patients with HCM have higher DFTs than patients implanted for other standard indications. Methods: We retrospectively reviewed the medical records of patients implanted with an ICD at the University of Maryland from 1996 to 2008. All patients with HCM who had DFTs determined were included. Data were compared to selected patients implanted for other standard indications over the same time period. All patients had a dual‐coil lead with an active pectoral can system and had full DFT testing using either a step‐down or binary search protocol. Results: The study group consisted of 23 HCM patients. The comparison group consisted of 294 patients. As expected, the HCM patients were younger (49 ± 18 years vs 63 ± 12 years; P < 0.00001) and had higher left ventricular ejection fractions (66% vs 32%; P < 0.000001). The average DFT in the HCM group was 13.9 ± 7.0 Joules (J) versus 9.8 ± 5.1 J in the comparison group (P = 0.0004). In the HCM group, five of the 23 patients (22%) had a DFT ≥ 20 J compared to 19 of 294 comparison patients (6%). There was a significant correlation between DFT and left ventricle wall thickness in the HCM group as measured by echocardiography (r = 0.44; P = 0.03); however, there was no correlation between DFT and QRS width in the HCM group (r = 0.1; P = NS). Conclusions: Our results suggest that patients with HCM have higher DFTs than patients implanted with ICDs for other indications. More importantly, a higher percentage of HCM patients have DFTs ≥ 20 J and the DFT increases with increasing left ventricle wall thickness. These data suggest that DFT testing should always be considered after implanting ICDs in HCM patients. (PACE 2010; 1342–1346)     

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.     

Survival and Appropriate Device Interventions in Recipients of Cardioverter Defibrillators Implanted for the Primary Versus Secondary Prevention of Sudden Cardiac Death

Background: Implantable cardioverter-defibrillators (ICD) implanted after an episode of ventricular tachyarrhythmia (VTA) or in patients at high risk of VTA lower the long-term mortality. Comparisons of the clinical outcomes of the two indications are scarce.
Methods: The study enrolled 360 consecutive ICD recipients. The device was implanted for secondary prevention in 150 patients, whose mean age was 60 ± 14 years, and mean left ventricular ejection fraction (LVEF) was 40 ± 16%, and for primary prevention in 210 patients, whose mean age was 61 ± 11 years, and mean LVEF was 31 ± 13%. All-cause mortality and time to first appropriate ICD therapy were measured.
Results: The two study groups were similar with respect to age and prevalence of coronary artery disease. Mean LVEF was higher in the secondary prevention group (P = 0.001). Cox regression analysis revealed a significantly shorter time to first appropriate ICD therapy in the secondary prevention group (HR = 0.51, 95% CI = 0.30 – 0.87, P = 0.01). Over a mean follow-up of 37 ± 19 months, the all-cause mortality in the overall population was 12.7%, and was similar in both subgroups (HR = 0.99, 95% CI = 0.55–1.77, P = 0.97).
Conclusions: The long-term mortality in this unselected population of ICD recipients was low. Patients treated for secondary prevention received earlier appropriate ICD therapy than patients treated for primary prevention. Long-term mortality was similar in both groups. The higher VT incidence of VTA was effectively treated by the ICD and was not associated with a higher mortality.     

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.     

Effects of Internal Defibrillation on an Implanted Pacing System with Programmable Polarity

Management of multiple cardiac arrhythmias in some patients with both an implantable cardioverter defibrillator (ICD) and a pacemaker has demonstrated several advantages. In such circumstances, it is imperative that pacemaker function and its programmed parameters be preserved following a deftbrillation shock. This article describes the effects encountered by a specific programmable polarity pacemaker (Relay® 294–03) when subjected to electrical defibrillation in a canine model. Three pacemakers were repeatedly tested in three separate dog experiments. Each pacemaker, with its leads implanted in the right atrium and the right ventricle, was subjected to a minimum total number of 24 high energy biphasic and monophasic shocks (600–700 V) delivered by a coexisting ICD system using three different defibrillating lead configurations. None of the pacemaker systems showed any failure in function; all pacemakers continued to function within preshock specification and conversion to unipolar pacing and/ or backup mode was not observed in any of the tests. Intracardiac electrical potentials measured directly off the ICD and the pacemaker leads, during a defibrillation shock (mean 566.6 V; 23.7 J), showed that potentials measured in a bipolar configuration (tip-ring: mean 21.0 V in atrium, 12.0 V in ventricle) were significantly less than potentials measured in a unipolar configuration (tip-can: mean 387.9 V in atrium, 394.0 V in ventricle; ring-can: mean 405.6 V in atrium, 395.4 V in ventricle). Our compatibility tests demonstrate that use of this programmable-polarity pacemaker in concert with an ICD system appears to be safe. Testing similar to the present study should be conducted prior to complete clinical acceptance of combined ICD and pacemaker implantation.     

Sleep-Disordered Breathing in Recipients of Implantable Defibrillators

Study Objectives: To examine the prevalence and clinical significance of sleep-disordered breathing in patients with implantable cardioverter defibrillators (ICD).
Methods and Results: Overnight sleep studies were performed in 129 ICD recipients who had no history of sleep apnea. The mean left ventricular ejection fraction (LVEF) was 29 ± 11%. Mild, moderate, and severe sleep apnea was diagnosed in the presence of an apnea/hypopnea index (AHI) of 5–15/h, 15.1–30/h, and >30/h, respectively. No sleep apnea was present in 49 patients (38%), 57 (44%) had central sleep apnea (CSA), and 23 patients (18%) had obstructive sleep apnea (OSA). Mild, moderate, and severe sleep apnea were present in 25%, 31%, and 44% of patients with CSA, compared with 52%, 22%, and 26% of patients with OSA (P < 0.05). LVEF was similar in patients with versus without OSA or CSA. Patients with CSA were significantly older and had a higher prevalence of ischemic cardiomyopathy than patients without sleep apnea.
Conclusions: Previously undiagnosed CSA is common in ICD recipients. Severely disordered breathing during sleep was more prevalent among patients with CSA than patients with OSA. This prospective, observational study will examine the long-term clinical significance of sleep-disordered breathing in ICD recipients.     

Impact of Dual Chamber Pacing on the Incidence of Atrial and Ventricular Tachyarrhythmias in Recipients of Implantable Cardioverter Defibrillators

Recent observations suggest that frequent dual-chamber pacing in recipients of implantable cardioverter defibrillators (ICD) may adversely influence clinical outcomes. This prospective, multicenter study examined the relationship between the frequency of atrial (%AP) and ventricular pacing (%VP) and the incidence of atrial (AT) and/or ventricular tachyarrhythmias (VT) in a standard ICD population. A total of 141 consecutive patients with primary and secondary ICD indications were studied. Continuous arrhythmia detection with a dual-chamber ICD revealed paroxysmal AT in 60 (43%) and VT in 72 (51%) patients within 6 months of device implantation. Far-field oversensing of ventricular signals occurred in 13% of all "atrial tachy response" mode switches. Without adjustment for covariates, a higher %AP was associated with an increased incidence of AT (P < 0.05). However, this association remained only weakly significant after adjustment for covariates using a multivariate model. High New York heart failure functional classes correlated significantly with AT (P = 0.02) and VT (P = 0.007). Rate-modulated pacing, programmed in 1/3 of patients, correlated with occurrence of AT (P = 0.006), but not with occurrence of VT. With respect to dual-chamber pacing, a %AP ≥ 48% combined with a %VP > 40% was associated with an increased probability for VT. In conclusion, AT and VT occurred frequently within 6 months after dual-chamber ICD implantation. High rates of DDD/R stimulation were associated with a trend toward higher incidence of AT, VT, or both.     

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 .     

Significance of Supraventricular Tachyarrhythmias in Patients with Implanted Pacing Cardioverter Defibrillators

Eighty-six patients were treated with an implantable cardioverter defibrillator (ICD) because of sustained ventricalar tachycardia (VT) or ventricular fibrillation (VF). In 27 patients an epicardial system was used, in 59 patients a transvenous system with a subcutaneous patch electrode was implanted. During a mean follow-up time of 17 ± 9 months, inappropriate activations of the ICD due to supraventricular tachycardia were documented by Holter monitoring in 14 patients (16%). In 8 patients paroxysmal atrial fibrillation (AF), in 2 patients chronic AF, in 1 patient atrial flutter, and in 3 patients sinus tachycardia triggered antitachycardia pacing functions (12 patients) or internal defibrillation (2 patients). In 3 patients (5%) VT was induced by inappropriate antitachycardia pacing. In an additional 18 patients (21%) inappropriate activation of antitachycardia functions due to atrial tachyarrhythmias were suspected based on telemetry readouts or the patient's history. Inappropriate activation of ICD therapy triggered by intermittent supraventricular tachyarrhythmias is common. Further improvements of detection algorithms for supraventricular tachycardia are required in future device generations.     

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.