Complications of Third-Generation Implantable Cardioverter Defibrillator Therapy

To determine the incidence of complications of third-generation implantable cardioverter defibrillator (ICD) therapy, 144 patients were prospectively studied who underwent first implant of third-generation devices (i.e., ICD systems with biphasic shocks, ECC storage capability, and nonthoracotomy lead systems). During 21 ± 15 months of follow-up, 41 (28%) patients had one or more complications. No patient died perioperatively (30 days) and no ICD infection was observed during follow-up. Complications included bleeding or pocket hematoma (hemoglobin drop > 2 g/dL) in 5 (3%) patients, prolonged reversible ischemic neurological deficit in 1 (1%) patient, postoperative deep venous thrombosis of leg in 1 (1%) patient, pneumothorax in 2 (1%) patients, difficulty to defibrillate ventricular fibrillation intraoperatively in 2 (1%) patients, generator malfunction in 1 (1%) patient, arthritis of the shoulder in 3 (2%) patients, and allergic reaction to prophylactic antibiotics in 2 (1%) patients. A total of seven lead related complications were observed in six (4%) patients including endocardial lead migration in four (3%) patients. Twenty-three (16%) patients received inappropriate shocks for supraventricular tachyarrhythmias (n = 13), non-sustained ventricular tachycardia (VT) (n = 7), or myopotential oversensing (n = 3). We conclude that serious complications such as perioperative death or ICD infection are rare in patients with third-generation ICDs. Lead-related problems and inappropriate shocks during follow-up are the most frequent complications of third-generation ICD therapy. Recognition of these complications should promote advances in ICD technology and management strategies to avoid their recurrence.     

Preliminary Experience with Nonthoracotomy Implantahle Cardioverter Defihrillators in Young Patients

Implantable cardioverter defihrillators represent an important treatment option for patients with life-threatening tachyarrhythinias. However, the requirement for surgical access to the thorax contributes to significant procedural morbidity with ICD implantation. This study was performed to assess an initial experience with a nonthoracotomy approach to ICD lead implantation in young patients. An international survey identified 17 patients, ranging in age from 12–20 years (mean = 16.7 ± 2.4) and weighing from 33–89 kg (mean = 60.6 ± 13.3), who had undergone placement of the Medtronic Transvene^R defibrillator lead system. Implant indications were aborted sudden cardiac death in 15 patients and recurrent ventricular tachycardia or familial sudden death in 2 patients. At a median follow-up of 7.9 months, 9 of 17 patients had received at least one ICD therapy. There have been no deaths. Complications included patch or generator erosion (3 patients), lead dislodgement (1 patient), and ICD system infection requiring explanation (1 patient). The initial experience with nonthoracotomy ICDs in young patients appears promising. This approach may be particularly advantageous for patients who have undergone prior thoracotomy. Prospective clinical trials will be required to establish the applicability of these lead systems to select patient populations.     

Defibrillation Thresholds and Perioperative Mortality Associated with Endocardial and Epicardial Defihrillation Lead Systems

Defibrillation thresholds (DFT) and perioperative mortality were evaluated in 123 patients who had endocardial defibrillation leads implanted in conjunction with the Medtronic model 7216A/7217 (Medtronic, Inc.) cardioverter-defibrillator (ICD). Clinical variables, implant DFTs, and 30-day perioperative mortality were compared with 266 patients who had the ICD implanted with epicardial defibrillation leads. The two groups were comparable in age, gender, and incidence of coronary artery disease. New York Heart Association Class I and II were more frequent in patients with endocardial leads (87.7%) as compared to those with epicardial leads (78.8%; P < 0.001). Mean left ventricular ejection fraction was significantly higher in patients with the endocardial lead system (37% vs 33%; P < 0.05). A significant proportion of patients with epicardial lead systems underwent another cardiac surgical procedure at the time of ICD implantation (13.9%) as compared to none in those who had endocardial leads implanted (P < 0.001). All patients with endocardial leads had implantation of triple lead systems as compared to 53.4% with epicardial leads (P < 0.001). The mean DFT at implant was lower in epicardial lead recipients (8.9 J) as compared to endocardial lead recipients (13.3 J; P < 0.001). Perioperative mortality had a significant trend to lower risk for endocardial lead systems (0.8%) as compared to epicardial systems (4.2%; P = 0.07). We conclude that this endocardial lead system has additional electrode and higher defibrillation energy requirements than the epicardial lead systems used with the Medtronic pacemaker ICD. However, the use of endocardial nonthoracotomy defibrillation leads is associated with a markedly reduced perioperative risk of ICD implantation. This could be due to patient characteristics, a less invasive implant procedure, and absence of concomitant cardiac surgery.     

Implantable cardioverter defibrillator in a child using a single subcutaneous array lead and an abdominal active can

This report describes the case of an 8-year-old boy with hypertrophic cardiomyopathy (HCM) who underwent ICD implantation for recurrent syncope. To avoid vascular complications and to minimize the surgical approach in this small child, a nonthoracotomy ICD system was chosen using a single subcutaneous array lead with only one finger, an abdominally placed active can, and epicardial dual chamber pacing and sensing electrodes. During an 8-month follow-up, DFT was confirmed and there were no ventricular tachycardia or complications. It appears to be a safe device for the prevention of sudden cardiac death in infants and small children.     

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.     

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.     

Experience with Two Different Nonthoracotomy Systems for Implantable Defibrillator in 170 Patients

Implantation of a nonthoracotomy system (Medtronic PCD or CPI Endotak) was attempted in 170 patients with ventricular tachycardia (VT) or ventricular fibrillation (VF) not requiring concomitant cardiac surgery. A nonthoracotomy system could be successfully implanted in 95 of the 115 patients with the PCD system and 49 of 55 patients receiving the Endotak lead system. In 26 patients with failed nontboracotomy system because of defibrillation threshold (DFT) > 25 joules (J), an epicardial system was implanted at the same setting. Patients receiving the two lead systems were comparable with regard to age, sex, and ejection fraction. However, since tbe PCD system offers tiered therapy multiprogrammable options, all attempts were made to implant tbis lead system in patients with VT that could be pace terminated. Mean DFT(15 ± 4.7 vs 17 ± 4.6 J;P = 0.03) and implant time (2.5 ± 0.6 vs 3.3 ± 0.7 hours; P = 0.02) were less with the Endotak lead system. There was no perioperative mortality. During a mean follow-up of 20 ± 4 months, there were eight instances of lead dislodgment in patients receiving the PCD system. Tbere were four nonsudden cardiac deaths and one sudden death in the Endotak group and three nonsudden deaths in the PCD group. Sudden cardiac death and total survival using the intention-to-treat analysis during this follow-up period were 99% and 95%, respectively. In conclusion, successful implantation, perioperative mortality, and survival rate are comparable with both lead systems; however, incorporating two defibrillating electrodes in one lead minimizes lead dislodgment and reduces implant time.     

Incidence of ICD Lead Related Complications During Long-Term Follow-Up: Comparison of Epicardial and Endocardial Electrode Systems

The aim of this study was to evaluate the longterm stability of epicardial and endocardial lead systems for third-generation cardioverter defibrillators (ICDs) and to assess the usefulness of diagnostic tools. One hundred forty patients with 61 epicardial (43.6%) and 79 nonthoracotomy systems (56.4%) were followed for 2 5 ± 19 months. A total of 18 (12.9%) lead related complications were documented. Complications of epicardial systems were detected in 10 patients (16.4%) during a follow-up time of 36 ± 8 months: crinkling of patch electrodes in 6 patients (9.8%), insulation breakage of sensing electrodes in 2 patients (3.3%), and adapter defect in 2 patients (3.3%). Eight of the patients (10.1%) with transvenous-subcutaneous systems had lead related complications during a 13 ± 6 months follow-up: fracture of the subcutaneous patch lead in 2 patients (2.5%), dislodgment of the right ventricular lead in 2 patients (2.5%), dislodgment of the superior vena cava lead in 2 patients (2.5%), insulation breakage of sensing electrodes in 1 patient (1.3%), and connector defect in 1 patient (1.3%). There was no significant difference in the incidence of lead related complications between epicardial and endocardial systems (P > 0.05). Fractures, dislodgments, and crinklings were documented within the first 8 ± 5 months by regular chest X ray. Defects of insulation, adapter, or connector were detected 22 ± 10 months after implantation and were associated with delivery of multiple inappropriate ICD therapies. An operative lead revision was indicated for 4 epicardial (6.6%) and 6 endocardial (7.6%) lead systems. Conclusions: Endocardial lead systems offer a similar long-term stability as compared to epicardial had systems. Chest X ray is the most useful tool to detect lead fracture, dislodgment. and patch crinkling. Marker recordings or real-time electrograms have not been helpful in this series to identify patients with suspected lead defects prior to the experience of inappropriate ICD discharges.     

Infections with Nonthoracotomy Implantable Cardioverter Defibrillators: Can These Be Prevented?

Nonthoracotomy ICDs are believed to be the best therapeutic modality for treatment of life-threatening ventricular arrhythmias. Little is known about the risk of infection with initial implantation of these devices. We studied the incidence, clinical characteristics, and risk factors associated with infections in 1,831 patients with nonthoracotomy ICD from the Endotak-C nonthoracotomy lead registry of Cardiac Pacemakers, Inc. A transvenous lead was implanted in 950 patients (51.9%) and a combination transvenous plus subcutaneous patch was used in 881 patients (48.1%). Nine preselected data variables were studied, and all investigators identified as having patients with infections were personally contacted. Infections occurred in 22 (1.2%) of 1,831 patients receiving this nonthoracotomy ICD system. The mean time to infection was 5.7 ± 6.5 months (range 1–25 months). Staphylococci were isolated in 58% of patients with reported infection. The presence of a subcutaneous defibrillator patch system was associated with the development of infection. Six of 950 patients (0.63%) with a totally transvenous lead system developed infection versus 16 of 838 (1.9%) patients with a transvenous lead plus subcutaneous patch system configuration (P = 0.015, Chi-square test), with an unadjusted estimated odds ratio of 3.06 (CI 1.19–7.86). The risk of infection encountered with the nonthoracotomy ICD is low, estimated from our data to be 1.2%. Placement of a subcutaneous defibrillator patch appears to be an independent risk factor for development of infection.     

Acute Efficacy and Chronic Follow-Up of Patients with Non-Thoracotomy Third Generation Implantahle Defibrillators

Non-thoracotomy implantation of implantable cardioverter defibrillators (ICDs) has simplified the process of device inserfion, promising to decrease associated procedural coniplications while providing sudden death protection at least equal to epicardial systems. This study presents the acute and chronic results of 110 patients who underwent attempted non-thoracotomy ICD impiuntation wiih the Medtronic Transvene lead system and PCD model 7217 or 7219. Of the 110 patients attempted, 100 (91%) had the system successfully implanted without the need for an epicar-dial patch. One patient died 1 week postoperatively of septic shock related to the implantation (0.9% perioperative mortality). During folloiv-up of 16 ± 11 months, 45% of the patients had an event detected as ventricular tachycardia; 26% of these detections were felt clinically to be due to supraventricular rhythms. Of the remainder, 87% were successfully treated with the first VT therapy, and 98% were terminated by the final therapy; 66% of the patients had at least one episode of ventricular fibrillation, of which 5% were felt to be inappropriate detections; 65% of the appropriate episodes were successfully treated with the first VF therapy, and all were converted by the final therapy. Total mortality at 6, 12, and 24 months was 3%, 11%, and 19% respectively. Only one patient had sudden cardiac death, occurring at 13 months postimplant. Overall, the non-thoracotomy lead system for this ICD displayed infrequent implant complications and proved to be reliable ai terminating arrhythmias and maintaining a low rate of sudden cardiac death in this high risk popuiation.     

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.     

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.     

The Combined Transvenous Implantation of Cardioverter Defibrillators and Permanent Pacemakers

We developed criteria for implantation and programming of permanent endocardial pacemakers in patients with a nonthoracotomy ICD system. These criteria were prospectively used in 10 patients who recieved an ICD prior to (n = 5) or following (n = 5) implantation of a dual chamber (n = 6) or ventricular (n = 4) pacemaker with a unipolar (n = 4) or bipolar (n = 6) lead configuration. All patients were tested for interactions or malfunctions. Undersensing of ventricular fibrillation by the atrial sense amplifier and inadequate atrial pacing occurred in one patient with a unipolar dual chamber system programmed to AAIR but didn't impair ICD sensing. Transient or permanent loss of capture or sensing of the pacemaker was not observed after ICD shocks with the output programmed to double pulse width and voltage of stimulation threshold and the sensitivity to 50% of the detected R wave. One episode of transient reprogramming occurred without clinical consequences. One unipolar ventricular pacemaker lead had to be exchanged against a bipolar lead because of oversensing of the pacing artifact by the ICD. There was no failure of an ICD to detect ventricular arrhythmias due to inadequate pacemaker activity. During a follow-up period of 21 ± 11 months, a total of 78 ventricular arrhythmias were effectively treated in six patients. Thus, a combined use of transvenous ICD and pacemaker is possible despite the close vicinity of pacing and defibrillations leads. Optimized programming different to the common settings is required. As interactions occurred only in unipolar pacemaker leads bipolar systems should be used in these patients.     

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.     

Implantation of an Automatic Defibrillator Using a New Nonthoracotomy Approach

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

Cost and Length of Hospital Stay: Comparisons Between Nonthoracotomy and Epicardial Techniques in Patients Receiving Implantable Cardioverter Defibrillators

Twenty-five patients with implantable Cardioverter defibrillators (ICDs) implanted intrathoracically (group I) were compared with 25 patients who underwent implant using the nonthoracotomy approach (group II). AH systems were implanted by the same medical team, in the same high volume implanting center. Indications for implantation were comparable in both groups. Patient characteristics were not statistically different with the exception of age fee-group I vs 71-group II; P < 0.05). Although left ventricular ejection fractions appeared to differ (32% vs 37%, respectively), this difference was not statistically significant (P = 0.06). ICD models used in group I were: Ventritex Cadence (16), Telectronics Guardian 4211 (2), Medtronic PCD (7); in group II they were: Ventritex Cadence (15), Guardian 4211 (2), and CPI 1600 (1). Total length of hospital stay was 16 ± 6 days for group I versus 12 ± 5 for group II (P < 0.05). Number of postoperative days in an intensive care unit was 3.2 ± 2.8 for group I versus 0.5 ± 0.6 for group II (P < 0.0001). Postoperative length of stay was 8.2 ± 3.1 for group I versus 5.7 ± 4.4 for group II (P < 0.001). Mean total hospital charges for the entire length of stay were $72,918 ±$26,770 in group I versus $55,031 ±$42,870 in group II, representing a mean reduction of 21 % in global costs for group II patients. These data confirm that nonthoracotomy ICD implantation in an experienced center is associated with significantly shorter hospital stays, a virtual elimination of the need for postoperative intensive care, and globally lower total hospital costs. In addition, the presence of a statistically older population in group II does not negate these beneficial effects.     

Implantable Cardioverter Defibrillator Implanted by Nonthoracotomy Approach: Initial Clinical Experience with the Redesigned Transvenous Lead System

Standard implantation procedure for the implantable Cardioverter defibrillator (ICD) has traditionary required a thoracotomy approach. A newly revised nonthoracotomy defibrillator lead system that uses a single transvenous tripolar endocardial lead alone or in combination with a subcutaneous/submuscular patch lead was introduced into clinical trials in September, 1990. Fourteen patients requiring a Cardioverter defibrillafor for recurrent sustained ventricular tachycardia (eight patients) or aborted sudden cardiac death (six patients) were evaluated for implantation of this lead system. Primary successful lead system implantation was obtained in nine patients. The remaining five patients had unacceptably high defibrillation thresholds (DFTs) for implantation. One of the nine initially successful implants demonstrated unacceptable DFTs and cross-talk inhibition from a permanent pacemaker necessitating removal of the nonthoracotomy lead system and replacement with a conventional lead system via thoracotomy. All remaining primary implanted patients experienced successful conversion of induced ventricular fibrillation prior to hospital discharge. Continued follow-up and greater experience to confirm the durability and efficacy of the nonthoracotomy AICD lead system are needed.     

Experience with Implantable Cardioverter-Defibrillator Therapy in Grown-Ups with Congenital Heart Disease

Implantable cardioverter-defibrillators (ICD) are increasingly implanted for primary or secondary prevention of sudden death in young patients with congenital heart disease, cardiomyopathies, or channelopathies. Although major advances in ICD technology and implant techniques have facilitated ICD therapy in young patients, complications such as lead failures, inappropriate shocks, system infections, and negative psychosocial impacts are of concern. The various underlying cardiovascular disease states and a lack of standardized ICD protocols for young patients often necessitate individualized implant techniques, ICD programming, and follow-up. Young ICD patients need a thorough follow-up to ensure adequate therapy, and psychosocial problems have to be addressed .     

Safety and effectiveness of primary prevention cardioverter defibrillators in octogenarians

Background: Implantable cardioverter‐defibrillators (ICDs) reduce the rate of sudden cardiac death (SCD) in patients with cardiomyopathy and reduced left ventricular systolic function. It is unclear if this benefit extends to the very elderly patient population. Methods: Patients who underwent initial ICD implantation at age 80 or older between January 1995 and April 2010 for primary SCD prevention were identified. Clinical data were collected from the medical record, including periprocedural complications, device type, and therapies delivered. Results: Three‐hundred eighty patients were identified; 84 patients met eligibility criteria. The mean age was 82.68 years; mean follow‐up was 34 months. Mean left ventricular ejection fraction was 28.1%. Mortality during follow‐up was 17.9%. One‐ and 5‐year survival estimates were 100% and 60%, respectively. Periprocedural complications occurred in 9.4% of patients; serious complications occurred in 4.8% with no periprocedural deaths. Device therapies occurred in 11.9% (n = 10) of patients (9.5% appropriate, n = 8; 2.4% inappropriate, n = 2). Cardiac resynchronization therapy‐defibrillator (CRT‐D) implantation was associated with prolonged median survival and decreased risk of death (hazard ratio 0.212; 95% confidence interval 0.048?.942, P = 0.042) compared to ICD alone. Conclusions: Implantation of primary prevention ICDs in patients 80 years of age or older was associated with a low risk of serious complications and a 5‐year survival estimate of 60%. Inappropriate therapies after implantation were uncommon. CRT‐D implantation was associated with a decreased risk of death compared to ICD alone. These data suggest that, in selected patients in this age group, ICD implantation is safe and effective. (PACE 2011; 34:900–906)     

Implanted cardioverters-defibrillators in the treatment of arrhythmias and prevention of sudden death

AIM: To present 15-year experience in use of implantable cardioverters-defibrillators (ICD) in patients with life threatening arrhythmias and a high risk of sudden cardiac death (SCD). MATERIAL AND METHODS: A total of 151 patients (116 males and 35 females aged 12-75 years) with life threatening arrhythmias and ICD were studied. RESULTS: There were neither complications nor lethality. Electrocardiotherapy was performed in 89 (58.9%) patients 4.5 +/- 9.4 months, on the average, after ICD implantation. Attacks of ventricular tachycardia (VT) were arrested by antitachycardia stimulation (974 episodes, 37.5 +/- 92.5 per patient, on the average). Effective cardioversion in VT was observed in 63 (41.7%) cases. Episodes of rapid ventricular tachycardia and ventricular fibrillation were stopped by defibrillation shocks in 28 (18.5%) patients. Additional surgical interventions were made in 3 patients because of electrodes dislocation, in 1--because of electrode brakage and in 1--suppuration of the bed. Fifteen patients (9%) died during follow-up because of cardiac failure (n = 13), cancer (n = 1), unknown cause (n = 1). CONCLUSION: Clinical application of ICD is not only treatment of arrhythmia and prevention of SCD but it is also a method of diagnosis, collection and accumulation of information about the disease course.