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PubMed2001

Implantation of cardioverter defibrillators without induction of ventricular fibrillation.

BACKGROUND: The upper limit of vulnerability (ULV) is the weakest shock at which ventricular fibrillation (VF) is not induced by a T-wave shock. This study tested the hypothesis that a vulnerability safety margin based on the ULV can be used as an implantable cardioverter-defibrillator implantation criterion. METHODS AND RESULTS: Implantable cardioverter-defibrillators were implanted in 80 patients if T-wave shocks did not induce VF and the baseline-rhythm R wave was >/=7 mV. The T-wave shock was 10 J in the first 45 patients (group A) and 15 J in the last 35 patients (group B). After inductionless implantations, the first VF shock was programmed to the T-wave shock plus 5 J. If T-wave shocks induced VF, the ULV was measured and the first shock was programmed to the ULV+5 J. Inductionless implantations were performed in 58 patients (72%), 28 in group A (62%) and 30 in group B (86%; P=0.04). If T-wave scanning had been done at 15 J in group A patients, inductionless implantations could have been performed in 84% of them. At 3 months, VF was induced twice during electrophysiological study in 75 patients (94%). All VFs were detected in </=4.7 s and were terminated by the first shock. During follow-up, 197 of 198 appropriate first shocks for rapid ventricular tachycardia or VF (99%) were successful in patients who had inductionless implantations (95% confidence intervals, 97% to 100%). CONCLUSION: Inductionless implantations can be performed in >80% of implantable cardioverter-defibrillator recipients using a vulnerability safety margin based on a T-wave scan at 15.

Aged↗
PubMed1994

Circadian variation of sustained ventricular tachycardia in patients with coronary artery disease and implantable cardioverter-defibrillators.

BACKGROUND: While previous studies using epidemiological data and ambulatory ECG monitoring have shown peak occurrence of sudden death and nonsustained ventricular tachycardia in the morning, none have examined circadian variation of potentially life-threatening ventricular tachycardia (VT), nor has any study observed circadian behavior of any arrhythmias in individuals followed longitudinally. We used the event memory of multiprogrammable implantable cardioverter-defibrillators to evaluate the circadian pattern of sustained VT over time. METHODS AND RESULTS: Data were reviewed from 32 consecutive patients with coronary artery disease and sustained VT who had received the Ventak PRX (CPI, Inc) cardioverter-defibrillator between May 1991 and August 1993 and had experienced at least one episode of VT terminated by their device. Mean follow-up was 14 +/- 7 months. Among the 2558 episodes recorded by the device logs, VT occurrence peaked between 6 AM and noon (P = .007 by ANOVA among four 6-hour time periods). Harmonic regression revealed a morning peak at 9 AM (P < .01). This morning peak occurred in patients with both frequent and infrequent events. Among 21 patients who experienced more than four VT events, 8 (38%) had an AM peak of VT occurrence (> 35% of VT between 6 AM and noon). Neither age, ejection fraction, event frequency, presenting arrhythmia, nor drug therapy distinguished patients who displayed the AM VT peak. CONCLUSIONS: In patients with coronary artery disease, sustained VT displays circadian variation with peak frequency in the morning, similar to that for sudden death. Individual patients who display specific patterns of circadian variation over time can be identified using defibrillator logs. Investigation of circadian variation of other phenomena to elucidate mechanisms of VT should focus on these patients.

Aged↗
PubMed1994

Implantation by electrophysiologists of 100 consecutive cardioverter defibrillators with nonthoracotomy lead systems.

BACKGROUND: Traditional lead systems for implantable cardioverter defibrillators (ICDs) require a thoracotomy for placement. Nonthoracotomy lead systems are available and are usually implanted by an electrophysiologist and a surgeon. The purpose of this study was to prospectively evaluate the safety and efficacy of ICD implantation with a nonthoracotomy lead system by electrophysiologists. METHODS AND RESULTS: A consecutive series of 100 patients (mean age, 61 +/- 13 years, +/- SD) underwent ICD implantation with a nonthoracotomy lead system while intubated and under general anesthesia. Seventy-seven patients had coronary artery disease, 15 had idiopathic cardiomyopathy, 6 had miscellaneous heart disease, and 2 had structurally normal hearts. The mean ejection fraction was 0.29 +/- 0.13. Sixty-eight patients had suffered a cardiac arrest, and 32 had had ventricular tachycardia or syncope. All patients except 9 underwent electrophysiological testing and had failed 1 +/- 1 drug trials before ICD implantation. Three types of nonthoracotomy lead systems were used. The nonthoracotomy lead with an ICD was successfully implanted in 96 patients (96%). Of the unsuccessful implants, 1 patient did not have venous access, the passive fixation lead in 1 would not remain lodged, 1 had elevated defibrillation thresholds, and 1 developed a hemopneumothorax while venous access was being obtained. The mean defibrillation threshold was 17 +/- 6 J. The mean procedure duration was 161 +/- 57 minutes. When a subcutaneous patch was used (n = 58), the procedure duration was 189 +/- 5 minutes, and when a subcutaneous patch was not required (n = 40), the procedure lasted 123 +/- 37 minutes (P < .0001). Patients remained in the hospital 4.5 +/- 4.1 days after implantation, with no procedure-related deaths. Acute complications occurred in 10 patients; 2 had lead dislodgments, 1 with previous abdominal surgery had his abdominal cavity entered (without other complications) while the ICD pocket was being made, 1 had postoperative heart failure, 1 developed a large hematoma when anticoagulation therapy was initiated, 3 required reintubation because of excessive anesthesia, 1 developed superficial cellulitis, and 1 developed a hemopneumothorax secondary to a lacerated subclavian vein. During 6 +/- 3 months of follow-up, 2 patients developed lead fractures. CONCLUSIONS: (1) Electrophysiologists can implant an ICD with a nonthoracotomy lead system safely and with a high success rate; (2) use of a subcutaneous patch correlates with longer procedure durations; and (3) special precautions should be taken in patients with previous abdominal surgery.

Anesthesia, General↗
PubMed1995

The proarrhythmic potential of implantable cardioverter-defibrillators.

The implantable cardioverter-defibrillator (ICD) is remarkably effective in preventing sudden cardiac death in high-risk patients, but it also has the capacity to provoke or worsen cardiac arrhythmias. Tachyarrhythmias or bradyarrhythmias may result from the delivery of antitachycardia or antibradycardia therapies by tiered-therapy defibrillators. This proarrhythmia, although rarely fatal, increases the morbidity associated with defibrillator therapy. Proarrhythmia is related as much to suboptimal programming as to technical limitations of the device. The proarrhythmic potential of ICD therapy can be minimized by tailoring the "electrical prescription" according to characteristics of the clinical arrhythmia and individual ICD idiosyncrasies.

Cardiac Pacing, Artificial↗
PubMed1998

Gross and microscopic pathological changes associated with nonthoracotomy implantable defibrillator leads.

BACKGROUND: Although the effects of epicardial implantable cardioverter-defibrillator (ICD) leads on underlying cardiac tissue have been reported, the gross and microscopic changes associated with endocardial ICD leads are less well described. This study describes the gross and microscopic changes associated with endocardial ICD leads in humans. METHODS AND RESULTS: The hearts from 8 patients were examined. At the time of ICD implantation, the patients' mean age was 47+/-11 years, and the left ventricular ejection fraction was 0.24+/-0.10. Four patients had ischemic heart disease, and 4 had dilated cardiomyopathy. Five hearts were examined after transplantation; 3, after death. The electrode-myocardial interfaces were characterized by intense endocardial fibrosis and were remarkably consistent. Each lead was encased by a ring of fibroelastic tissue, and there was fibrosis of the right ventricular myocardium adjacent to the leads. Fibrosis involved the tricuspid valve in 5 patients, and 1 had perforation of the valve by the lead. Microscopically, interstitial fibrosis was adjacent to each lead in the current path of ICD shocks. Acute cell injury was present only in the hearts that had received recent shocks. CONCLUSIONS: The ICD electrode-myocardial interface is characterized by intense fibrosis. The fibrosis associated with endocardial ICD leads and the cumulative acute damage produced by defibrillation discharges may explain changes in the defibrillation and pacing thresholds and the difficulty of lead extraction that can be encountered with transvenous ICD systems.

Adult↗
PubMed1999

Virtual electrode-induced reexcitation: A mechanism of defibrillation.

Mechanisms of defibrillation remain poorly understood. Defibrillation success depends on the elimination of fibrillation without shock-induced arrhythmogenesis. We optically mapped selected epicardial regions of rabbit hearts (n=20) during shocks applied with the use of implantable defibrillator electrodes during the refractory period. Monophasic shocks resulted in virtual electrode polarization (VEP). Positive values of VEP resulted in a prolongation of the action potential duration, whereas negative polarization shortened the action potential duration, resulting in partial or complete recovery of the excitability. After a shock, new propagated wavefronts emerged at the boundary between the 2 regions and reexcited negatively polarized regions. Conduction velocity and maximum action potential upstroke rate of rise dV/dt (max) of shock-induced activation depended on the transmembrane potential at the end of the shock. Linear regression analysis showed that dV/dt(max) of postshock activation reached 50% of that of normal action potential at a V(m) value of -56.7+/-0.6 mV postshock voltage (n=9257). Less negative potentials resulted in slow conduction and blocks, whereas more negative potentials resulted in faster conduction. Although wavebreaks were produced in either condition, they degenerated into arrhythmias only when conduction was slow. Shock-induced VEP is essential in extinguishing fibrillation but can reinduce arrhythmias by producing excitable gaps. Reexcitation of these gaps through progressive increase in shock strength may provide the basis for the lower and upper limits of vulnerability. The former may correspond to the origination of slow wavefronts of reexcitation and phase singularities. The latter corresponds to fast conduction during which wavebreaks no longer produce sustained arrhythmias.

Animals↗
PubMed2005

Incidence and clinical relevance of slow ventricular tachycardia in implantable cardioverter-defibrillator recipients: an international multicenter prospective study.

BACKGROUND: This study aims to assess the incidence and clinical relevance of slow ventricular tachycardia (VT) and the effectiveness and/or deleterious effects of antitachycardia pacing in slow VT in implantable cardioverter-defibrillator recipients. METHODS AND RESULTS: This multicenter prospective randomized study included 374 patients (326 men) without prior history of slow VT (<148 bpm) implanted with a dual-chamber implantable cardioverter-defibrillator. Patients had a 3-zone detection configuration: a slow VT zone (101 to 148 bpm), a conventional VT zone (>148 bpm), and a ventricular fibrillation zone. Patients were randomized to a treatment group (n=183) with therapy activated in the slow VT zone or a monitoring group (n=191) with no therapy in the slow VT zone. During follow-up (11 months), 449 slow VTs occurred in 114 patients (30.5% slow VT incidence); 181 VTs (54 patients) occurred in the monitoring group; 3 were readmitted to the hospital; and lightheadedness and palpitations occurred in 4 and 250 (60 patients) in the treatment group treated by antitachycardia pacing (89.8% success rate) and shock delivery (n=2). There were 10 crossovers from the monitoring to treatment group and 3 crossovers from the treatment to monitoring group (P=0.09). Quality of life scores were not different between groups. CONCLUSIONS: Slow VT incidence (<150 bpm) is high (30%) in implantable cardioverter-defibrillator recipients without prior history of slow VT, has limited clinical relevance, and is efficiently and safely terminated by antitachycardia pacing.

Adult↗
PubMed2006

Is dual-chamber programming inferior to single-chamber programming in an implantable cardioverter-defibrillator? Results of the INTRINSIC RV (Inhibition of Unnecessary RV Pacing With AVSH in ICDs) study.

BACKGROUND: The INTRINSIC RV (Inhibition of Unnecessary RV Pacing with AVSH in ICDs) study tested the hypothesis that dual-chamber rate-responsive (DDDR) with atrioventricular search hysteresis (AVSH) 60-130 programming is not inferior to single-chamber (VVI)-40 programming in an implantable cardioverter defibrillator with respect to all-cause mortality and heart failure hospitalizations using an equivalence margin of 5%. METHODS AND RESULTS: At 108 centers, 1530 patients with an implantable cardioverter defibrillator indication received a VITALITY AVT (Guidant Corporation, St. Paul, Minn) implantable cardioverter defibrillator programmed consistently to DDDR AVSH 60-130 for the first week. Of those, 988 patients with <20% right ventricular pacing at 1 week were randomized to DDDR AVSH 60-130 or to VVI-40 programming. Among those randomized, 502 were assigned to DDDR AVSH and 486 to VVI. Groups were similar with regard to coronary disease (68%), gender (21% female), and New York Heart Association functional class >I (79%). A total of 32 patients (6.4%) in the DDDR AVSH arm and 46 patients (9.5%) in the VVI arm died or were hospitalized for heart failure during a mean follow-up of 10.4 months (relative risk=0.67, P=0.072 in favor of DDDR AVSH). DDDR AVSH was not inferior to VVI programming (P<0.001). All-cause mortality was not significantly different between the DDDR AVSH arm (3.6%) and the VVI arm (5.1%; P=0.23). The mean percent right ventricular pacing in the DDDR AVSH arm was 10% (median 4%) versus 3% (median 0%) in the VVI arm. CONCLUSIONS: In the INTRINSIC RV trial, among those randomized, DDDR AVSH was associated with similar outcomes as with VVI backup pacing.

Adult↗
PubMed2001

Staphylococcus aureus bacteremia in patients with permanent pacemakers or implantable cardioverter-defibrillators.

BACKGROUND: Although cardiac device infections (CDIs) are a devastating complication of permanent pacemakers or implantable cardioverter-defibrillators, the incidence of CDI in patients with bacteremia is not well defined. The objective of this study was to determine the incidence of CDI among patients with permanent pacemakers or implantable cardioverter-defibrillators who develop Staphylococcus aureus bacteremia (SAB). METHODS AND RESULTS: A cohort of all adult patients with SAB and permanent pacemakers or implantable cardioverter-defibrillators over a 6-year period was evaluated prospectively. The overall incidence of confirmed CDI was 15 of 33 (45.4%). Confirmed CDI occurred in 9 of the 12 patients (75%) with early SAB (<1 year after device placement). Fifteen of 21 patients (71.5%) with late SAB (>/=1 year after device placement) had either confirmed (6 of 21, 28.5%) or possible (9 of 21, 43%) CDI. In 60% of the patients (9 of 15) with confirmed CDI, no local signs or symptoms suggesting generator pocket infection were noted. CONCLUSIONS: The incidence of CDI among patients with SAB and cardiac devices is high. Neither physical examination nor echocardiography can exclude the possibility of CDI. In patients with early SAB, the device is usually involved, and approximately 40% of these patients have obvious clinical signs of cardiac device involvement. Conversely, in patients with late SAB, the cardiac device is rarely the initial source of bacteremia, and there is a paucity of local signs of device involvement. The cardiac device is involved, however, in >/=28% of these patients.

Aged↗
PubMed2001

Right atrial septal electrode for reducing the atrial defibrillation threshold.

BACKGROUND: The atrial defibrillation threshold (ADFT) energy of the standard lead configuration, right atrial appendage (RAA) to coronary sinus (CS), was reduced by >50% with the addition of a third electrode traversing the atrial septum in a previous study. This study determined whether the ADFT would be lowered by a more clinically practical third electrode placed in the right atrium along the atrial septum (RSP). METHODS AND RESULTS: Sustained atrial fibrillation was induced in 8 closed-chest sheep with burst pacing and maintained with pericardial infusion of acetyl-beta-methylcholine chloride. A custom-made, dual-defibrillation catheter was placed with electrodes in the lateral RA, CS, and RSP. A separate defibrillation catheter was also placed in the RAA. ADFT characteristics of RAA-->CS and 6 other single- or sequential-shock configurations were determined in random order by using biphasic, truncated-exponential waveforms in a multiple-reversal protocol. The delivered-energy, peak-voltage, and peak-current ADFTs for the sequential-shock configuration CS-->RSP/RA-->RSP (0.53+/-0.31 J, 86+/-22 V, and 1.6+/-0.6 A, respectively) were significantly lower than those of RAA-->CS (1.14+/-0.64 J, 157+/-34 V, and 2.5+/-1.1 A, respectively). The ADFT characteristics of RAA-->CS and RA-->CS were not significantly different, nor were those of CS-->RSP/RA-->RSP and CS-->RSP/RAA--> RSP. CONCLUSIONS: The ADFT of the standard RAA-->CS configuration may be markedly reduced with an additional electrode situated at the RSP.

Animals↗
PubMed2005

Charging up the public for automated external defibrillators.

Public training in the use of automated external defibrillators to treat out-of-hospital cardiac arrests has been receiving increased attention. The implementation of public access defibrillation programs has been the most significant intervention to improve survival in decades. Dramatic success came when we placed automated external defibrillators in the hands of the public to be utilized without an Emergency Medical Services response having to occur. The device is simple to operate -- sixth-grade children have demonstrated safe and effective operation. Training should be taken to its elemental level. Cardiopulmonary resuscitation training should not be forgotten; it too should be taken to its simplest form.

Cardiopulmonary Resuscitation↗
PubMed2005

Implementation of community-based public access defibrillation in the PAD trial.

BACKGROUND: The Public Access Defibrillation (PAD) Trial was a randomized, controlled trial designed to measure survival to hospital discharge following out-of-hospital cardiac arrest (OOH-CA) in community facilities trained and equipped to provide PAD, compared with community facilities trained to provide cardiopulmonary resuscitation (CPR) without any capacity for defibrillation. OBJECTIVES: To report the implementation of community-based lay responder emergency response programs in 1,260 participating facilities recruited for the PAD Trial in the United States and Canada. METHODS: This was a descriptive study of the characteristics of participating facilities, volunteers, and automated external defibrillator (AED) placements compiled by the PAD Trial, and a qualitative study of factors that facilitated or impeded implementation of emergency lay responder programs using focus groups of PAD Trial site coordinators. RESULTS: The PAD Trial enrolled 1,260 community facilities (14.8% residential), with 20,400 lay volunteers (mean +/- standard deviation = 13.4 +/- 10.7 per facility) trained to respond to OOH-CA. The 598 locations randomized to receive AEDs required 2.7 +/- 1.8 AEDs per facility. Volunteer attrition was high, 36% after two years. Barriers to recruitment and implementation included identification of appropriate "at-risk" facilities, lack of interest or fear of litigation by a facility key decision maker, lack of motivated potential volunteer responders, training and retraining resource requirements, and lack of an existing communication/response infrastructure. CONCLUSIONS: These data indicate that implementation of community-based lay responder programs is feasible in many types of facilities, although these programs require substantial resources and commitment, and many barriers to implementation of effective PAD programs exist.

Age Distribution↗
PubMed2005

Fracture of the subcutaneous patch electrode in a patient with an implanted cardioverter-defibrillator.

There are more than 20 years of experience with implantation of defibrillator devices in humans and the procedure is an important therapeutic option for patients at high risk of life-threatening ventricular arrhythmias. The incidence of new defibrillator implantation has gradually increased, being used even in children, (1) although pediatric use is associated with several complications, especially with epicardial systems,(2) including fracture of the subcutaneous patch,(3-5) mainly because of growth.(3) We present a case of subcutaneous patch electrode fracture in the left axillary pectoral region of a patient who needed the patch for effective defibrillation, and we discuss the methods of treatment.

Adult↗
PubMed1999

Development of ventricular fibrillations with different characteristics in the local electrocardiogram: large and small amplitude of activation, and its implication for implantable cardioverter defibrillator treatment.

An implantable cardioverter defibrillator (ICD) was implanted in 2 patients with ventricular tachyarrhythmia related to old myocardial infarction, and defibrillation tests were attempted at the time of ICD implantation and at 2 or 4 weeks after the operation. Ventricular fibrillation (VF) was induced by T-wave shocks, but the amplitude of the ventricular electrogram was different in each VF. In most of the VFs with large ventricular electrograms, the local activity was appropriately detected. However, many undersensed beats were observed in other VFs that had fine ventricular electrograms and a longer time was needed before delivering the shock. The amplitude of the ventricular electrogram might be small in some cases of VF and this might result in undersensing and/or unsuccessful defibrillation. Close attention must be paid to the amplitude of ventricular activation in each VF to avoid possible difficulty in ICD therapy.

Aged↗
PubMed2001

The right ventricular outflow tract as an unusual location for an implantable defibrillator electrode in a patient with arrhythmogenic right ventricular dysplasia.

A 41-year-old woman with arrhythmogenic right ventricular dysplasia (ARVD) underwent the implantation of an implantable cardioverter-defibrillator (ICD), in which the defibrillator electrode was unusually located in the right ventricular (RV) outflow tract. Although fractionated electrograms were demonstrated in the RV apex, which is the usual site for ICD electrodes, normal electrograms were recorded in the RV outflow tract during an electrophysiologic study. An electrode with a screw-in tip was used to fix the implant in the RV outflow tract and obtain successful defibrillation. If normal electrograms are recorded in the RV outflow tract, the site may prove to be an alternative location for an ICD electrode even for ARVD patients.

Adult↗
PubMed2004

Implantable cardioverter defibrillators in children.

The use of implantable cardioverter defibrillators in children presents several unique challenges for the pediatric cardiologist. Size considerations and hardware limitations are important in the current generation of devices that are not designed with children in mind. Defibrillator devices are used to prolong life, which may have significant implications for leads and electrodes that are affixed to the heart in a child who has continued growth potential. A greater number of children with congenital heart defects are surviving into adulthood, many of whom have a risk of late sudden death following repair. These patients may also have unique anatomic considerations that may affect device placement. This article will address some of the issues faced when considering the use of implantable-defibrillator therapy in the pediatric population.

Arrhythmias, Cardiac↗
PubMed2005

The fully automatic external cardioverter defibrillator: reality of a new meaningful scenario for in-hospital cardiac arrests.

Sudden cardiac death is an unresolved problem which causes significant mortality and morbidity in both the community and in-hospital setting. Cardiac arrest is often caused by ventricular tachyarrhythmias which may be mostly interrupted by cardioversion or defibrillation. The single most critical factor for survival is the response time. Over the last 30 years, there have been virtually no procedural changes in the way hospitals address in-hospital resuscitation. A unique device has been developed that eliminates human intervention and assures defibrillation therapy is administered in seconds. This is accomplished with a fully automatic, external bedside monitor defibrillator designed to be prophylactically attached to hospitalized patients at risk of ventricular tachyarrhythmia. The safety and efficacy of the device has been demonstrated in multicenter US and European trials. Thus, this device allows a new scenario which may increase survival and enables meaningful redistribution of health resources.

Clinical Trials as Topic↗
PubMed2001

Laser assisted extraction of pacemaker and implantable defibrillator leads.

OBJECTIVE: To analyze the results of laser-assisted extraction of permanent pacemaker and defibrillator leads. METHODS: We operated upon 36 patients, whose mean age was 54.2 years, and extracted 56 leads. The reasons for extracting the leads were as follows: infection in 19 patients, elective replacement in 13, and other causes in 4 patients. The mean time of catheter placement was 7.5+/-5.5 years. Forty-seven leads were from pacemakers, and 9 were from defibrillators. Thirty-eight leads were in use, 14 had been abandoned in the pacemaker pocket, and 4 had been abandoned inside the venous system. RESULTS: We successfully extracted 54 catheters, obtaining a 96.4% rate of success and an 82.1% rate for complete extraction. The 2 unsuccessful cases were due to the presence of calcium in the trajectory of the lead. The mean duration of laser light application was 123.0+/-104.5 s, using 5,215.2+/-4,924.0 pulses, in a total of 24.4+/-24.2 cycles of application. Thirty-four leads were extracted from the myocardium with countertraction after complete progression of the laser sheath, 12 leads came loose during the progression of the laser sheath, and the remaining 10 were extracted with other maneuvers. One patient experienced cardiac tamponade after extraction of the defibrillator lead, requiring open emergency surgery. CONCLUSION: The use of the excimer laser allowed extraction of the leads with a 96% rate of success; it was not effective in 2 patients who had calcification on the lead. One patient (2.8%) had a complication that required cardiac surgery on an emergency basis.

Adolescent↗