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  • 1
    Electronic Resource
    Electronic Resource
    Defibrillation Efficacy Comparing a Subcutaneous Array Electrode versus an “Active Can” Implantable Cardioverter Defibrillator and a Subcutaneous Array Electrode in Addition to an “Active Can” Implantable Cardioverter Defibrillator: Results from Active Can versus Array Trials I and II (2001)
    Oxford, UK : Blackwell Science Inc
    Journal of cardiovascular electrophysiology 12 (2001), S. 0 
    Details
    ISSN: 1540-8167
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Defibrillation Efficacy. Introduction: Placement of implantable cardioverter defibrillators (ICDs) has been simplified by using the shell of a pectorally implanted ICD as a defibrillation electrode in combination with an endocardial right ventricular defibrillation lead. However, a sufficiently low defibrillation threshold (DFT) cannot be obtained in a few patients. Therefore, alternative approaches were systematically tested in the Active Can versus Array Trial (ACAT). Methods and Results: In the first of two prospective randomized studies, the DFT of a subcutaneous left dorsolateral array anode introduced from a pectoral incision was compared to that of a standard active can anode in 68 patients. Intraoperatively, the DFT was determined twice in each patient using either the active can or, in patients with a subcutaneous array lead, once with all three fingers and once omitting the middle finger of the array. The second prospective randomized study included 40 patients. DFT also was determined twice in each patient using an active can in a left pectoral position as anode alone and combined with a left dorsolateral array electrode with two fingers. In ACAT I, stored energy at DFT decreased from 13.1 ± 7.7 J (active can) to 9.6 ± 6.1 J (three-finger array lead) (P = 0.04), impedance decreased from 53 ± 8 Ω to 40 ± 6 Ω (P 〈 0.0001). Omitting the middle finger of the array lead, stored energy at DFT increased by 0.9 J (P = 0.47) and impedance by 2 Ω (P 〈 0.0001). In ACAT II, DFT and impedance using an active can device were significantly lower when a two-finger array lead was added that decreased stored energy at DFT from 10.1 ± 5.2 J to 6.9 ± 3.9 J (P = 0.001) and impedance from 56 ± 5 Ω to 42 ± 5 Ω (P 〈 0.0001). Conclusion: In combination with a right ventricular defibrillation electrode, a left pectoral subcutaneous array lead improves defibrillation efficacy if used instead of, or in addition to, a left pectoral active can ICD device. Implantation of the array lead can be simplified by using two instead of three fingers, without a significant loss of defibrillation efficacy.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1046/j.1540-8167.2001.00921.x
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  • 2
    Electronic Resource
    Electronic Resource
    Nonthoracotomy Implantable Cardioverter Defibrillator Placement in Children: Use of Subcutaneous Array Leads and Abdominally Placed Implantable Cardioverter Defibrillators in Children (2001)
    Oxford, UK : Blackwell Science Inc
    Journal of cardiovascular electrophysiology 12 (2001), S. 0 
    Details
    ISSN: 1540-8167
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Nonthoracotomy ICD in Children. Introduction: The need to access the right ventricle might preclude transvenous placement of a defibrillation lead at implantable cardioverter defibrillator (ICD) placement, especially in small children or children with complex congenital heart defects. We investigated a subcutaneous array lead in addition to an abdominally placed “active can” ICD device in two children to avoid a thoracotomy. Methods and Results: The first child (age 12 years, 138 cm, 41 kg) had transposition of the great arteries with a subsequent surgical intra-atrial correction by the Mustard technique. The second child (age 14 years, 161 cm, 54 kg) had a single atrium and a single ventricle, d-transposition of the aorta, and atresia of the main pulmonary artery with a surgical anastomosis between the aorta and the right pulmonary artery by the Cooley technique. The defibrillation threshold was 18 J and 〈 20 J at initial implantation and at generator replacement in the first patient and 20 J in the second patient. During follow-up of 6 years and 1 month, respectively, no ICD-related complications occurred. Conclusion: In children in whom endocardial, right ventricular placement of a defibrillation lead is precluded, defibrillation is possible and safe between an abdominally placed “active can” ICD device and a subcutaneous array lead. This approach may avoid a thoracotomy in children with no possibility for transvenous ICD placement.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1046/j.1540-8167.2001.00356.x
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  • 3
    Electronic Resource
    Electronic Resource
    Efficacy and Safety of the Initial Use of Stability and Onset Criteria in Implantable Cardioverter Defibrillators (1999)
    Oxford, UK : Blackwell Publishing Ltd
    Journal of cardiovascular electrophysiology 10 (1999), S. 0 
    Details
    ISSN: 1540-8167
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Primary Programming of Stability and Onset Criteria. Introduction: Inappropriate therapies are the most frequent adverse event in patients with implantable cardioverter defibrillators (ICDs). Most ICDs offer a stability criterion to discriminate ventricular tachycardia (VT) from atrial fibrillation and an onset criterion to discriminate VT from sinus tachycardia. The efficacy and safety of these criteria, if used immediately after implantation, is unknown. Methods and Results: In a case control study, 87 patients in whom stability and onset criteria had been activated immediately after ICD implantation were matched to 87 patients in whom these criteria had not been activated. The groups were matched for known predictors of inappropriate therapies. With stability and onset criteria off, 24 patients (28%) received inappropriate therapies due to atrial fibrillation (n = 14) or sinus tachycardia (n = 11); with stability and onset on, only 11 patients (13%) were treated by the ICD due to atrial fibrillation (n = 5) or sinus tachycardia (n = 7) (log rank: P = 0.029). Five patients suffered inappropriate therapies despite the fact that onset (n = 4) or stability (n = 1) criteria were not fulfilled once tachycardias continued for a prespecified duration. Only one patient experienced a failure to detect VT due to the onset criterion; none because of stability. Conclusion: The immediate use of stability and onset criteria after ICD implantation reduces inappropriate therapies due to atrial fibrillation and sinus tachycardia. Because of the potential for underdetection of VT, this approach should be limited to tachycardia rates hemodynamically tolerated by the patient.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1111/j.1540-8167.1999.tb00655.x
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  • 4
    Electronic Resource
    Electronic Resource
    Combined P/S-HV ICD Lead Implantation Via the Coronary Sinus in a Patient with a Prosthetic Tricuspid Valve (2005)
    350 Main Street , Malden , MA 02148-5018 , USA , and 9600 Garsington Road , Oxford OX4 2DQ , UK . : Blackwell Science Inc
    Journal of cardiovascular electrophysiology 16 (2005), S. 0 
    Details
    ISSN: 1540-8167
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1046/j.1540-8167.2005.40735.x
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  • 5
    Electronic Resource
    Electronic Resource
    Mortality, Morbidity, and Complications in 3,344 Patients with Implantable Cardioverter Defibrillators: (2003)
    350 Main Street , Malden , MA 02148-5018 , USA , and 9600 Garsington Road , Oxford OX4 2DQ , UK . : Blackwell Futura Publishing, Inc.
    Pacing and clinical electrophysiology 26 (2003), S. 0 
    Details
    ISSN: 1540-8159
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: ICDs are the therapy of choice in patients with life-threatening ventricular arrhythmias. Mortality, morbidity, and complication rates including appropriate and inappropriate therapies are unknown when ICDs are used in routine medical care and not in well-defined patients included in multicenter trials. Therefore, the data of 3,344 patients ( 61.1 ± 12.1  years ; 80.2% men; CAD 64.6%, dilated cardiomyopathy 18.9%; NYHA Class I–III: 19.1%, 54.3%, 20.1%, respectively; LVEF 〉 0.50 : 0.234, LVEF 0.30–0.50: 0.472, LVEF 〈 0.30 : 0.293, respectively) implanted in 62 German hospitals between January 1998 and October 2000 were prospectively collected and analyzed as a part of the European Registry of Implantable Defibrillators (EURID Germany). The 1-year survival rate was 93.5%. Patients in NYHA Class III and a LVEF 〈 0.30 had a lower survival rate than patients in NYHA Class I and a preserved LVEF (0.852 vs 0.975, P = 0.0001 ). Including the 1-year follow-up, 49.5% of patients had an intervention by the ICD, 39.8% had appropriate ICD therapies, 16.2% had inappropriate therapies. Overall, 1,691 hospital readmissions were recorded. The main causes for hospital readmissions were ventricular arrhythmias (61.3%) and congestive heart failure symptoms (12.9%). Thus, demographic data and mortality of patients treated with an ICD in conditions of standard medical care seems to be comparable and based on, or congruent with, the large secondary preventions trials. When ICDs are used in standard medical care, the 1-year survival rate is high, especially in patients with NYHA Class I and preserved LVEF. However, nearly half of all patients suffer from ICD intervention. (PACE 2003; 26[Pt. I]:1511–1518)
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1046/j.1460-9592.2003.t01-1-00219.x
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  • 6
    Electronic Resource
    Electronic Resource
    ICD Leads: (2003)
    350 Main Street , Malden , MA 02148-5018 , USA . : Blackwell Futura Publishing, Inc.
    Pacing and clinical electrophysiology 26 (2003), S. 0 
    Details
    ISSN: 1540-8159
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: GRADAUS, R., et al.: ICD Leads: Design and Chronic Dysfunctions. The treatment of ventricular tachyarrhythmias has changed over the last 10 years. Implantable cardioverter defibrillators (ICDs), once used only as a last resort therapy, have now become the treatment of choice. This change occurred before the first results of randomized studies on ICD therapy in patients with life-threatening ventricular tachyarrhythmias were published by the end of 1997. Technological advances of ICD therapy, in particular the development of transvenous leads, were to a large extent responsible for this change. Modern leads are characterized by their multilumen design that incorporates straight wires and coiled conductors into a single electrode body. Conductors and insulation are sheathed with additional insulation layers. The most frequently used insulating materials are silicone, polyurethane, and fluoropolymers. Lead failures are an important complication of ICD therapy. Fractured conductors, compression, creeping, or insulation defects from abrasion can cause such lead dysfunctions. Chronically implanted leads will inevitably have an increased risk of failure due to defects despite all technological advances. In the light of improving survival figures in patients with ventricular tachyarrhythmias and increasing numbers of ICD implantations, lead failures are becoming a clinical problem of ever increasing importance. Therefore, the question of which lead types necessitate extraction when a certain failure occurs and which leads can be left in place. Despite continuous improvements in lead extraction systems and growing experience in their use, the extraction of any pacemaker or ICD lead is associated with some risk of complications. (PACE 2003; 26[Pt. I]:649–657)
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1046/j.1460-9592.2003.00112.x
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  • 7
    Electronic Resource
    Electronic Resource
    Effect of Ventricular Fibrillation Duration on the Defibrillation Threshold in Humans (2002)
    Oxford, UK : Blackwell Futura Publishing, Inc.
    Pacing and clinical electrophysiology 25 (2002), S. 0 
    Details
    ISSN: 1540-8159
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: GRADAUS, R., et al.: Effect of Ventricular Fibrillation Duration on the Defibrillation Threshold in Humans. Early during ventricular fibrillation, the defibrillation threshold may be low, as ventricular fibrillation most probably arises from a localized area with only a few wavefronts and the effects of global ischemia, ventricular dilatation, and sympathetic discharge have not yet fully developed. The purpose of this study was to explore the effect of the timing of shock delivery in humans. During implantation of an ICD in 26 patients (24 men, 60 ± 11 years, 19 coronary artery disease, NYHA 2.2 ± 0.4, left ventricular ejection fraction 0.42 ± 0.16), the defibrillation threshold was determined after approximately 10 and 2 seconds of ventricular fibrillation. Ventricular fibrillation was induced by T wave shocks. Mean defibrillation threshold was 9.9 ± 3.6 J after 10.3 ± 1.0 seconds. Within 2 seconds, 20 of 26 patients could be successfully defibrillated with ≤ 8 J. In these patients, the mean defibrillation threshold was 4.0 ± 2.1 J after 1.4 ± 0.3 seconds compared to 9.5 ± 3.1 J after 10.2 ± 1.1 seconds (P 〈 0.001). There were no clinical differences between patients who could be successfully defibrillated within 2 seconds and those patients without successful defibrillation within 2 seconds. In the majority of patients, the defibrillation threshold was significantly lower within the first few cycles of ventricular fibrillation than after 10 seconds of ventricular fibrillation. These results should lead to exploration of earlier shock delivery in implantable devices. This could possibly reduce the incidence of syncope in patients with rapid ventricular tachyarrhythmias and ICDs.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1046/j.1460-9592.2002.00014.x
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  • 8
    Electronic Resource
    Electronic Resource
    Implantation of a Dual Chamber Pacing and Sensing Single Pass Defibrillation Lead (2001)
    Oxford, UK : Blackwell Futura Publishing, Inc.
    Pacing and clinical electrophysiology 24 (2001), S. 0 
    Details
    ISSN: 1540-8159
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: GRADAUS, R., et al.: Implantation of a Dual Chamber Pacing and Sensing Single Pass Defibrillation Lead. Dual-chamber ICDs are increasingly used to avoid inappropriate shocks due to supraventricular tachycardias. Additionally, many ICD patients will probably benefit from dual chamber pacing. The purpose of this pilot study was to evaluate the intraoperative performance and short-term follow-up of an innovative single pass right ventricular defibrillation lead capable of bipolar sensing and pacing in the right atrium and ventricle. Implantation of this single pass right ventricular defibrillation lead was successful in all 13 patients (age 63 ± 8 years; LVEF 0.44 ± 0.16; New York Heart Association [NYHA] 2.4 ± 0.4, previous open heart surgery in all patients). The operation time was 79 ± 29 minutes, the fluoroscopy time 4.7 ± 3.1 minutes. No perioperative complications occurred. The intraoperative atrial sensing was 1.7 ± 0.5 mV, the atrial pacing threshold product was 0.20 ± 0.14 V/ms (range 0.03–0.50 V/ms). The defibrillation threshold was 8.8 ± 2.7 J. At prehospital discharge and at 1-month and 3-month follow-up, atrial sensing was 1.9 ± 0.9, 2.1 ± 0.5, and 2.7 ± 0.6 mV, respectively, (P = NS, P 〈 0.05, P 〈 0.05 to implant, respectively), the mean atrial threshold product 0.79, 1.65, and 1.29 V/ms, respectively. In two patients, an intermittent exit block occurred in different body postures. All spontaneous and induced ventricular arrhythmias were detected and terminated appropriately. Thus, in a highly selected patient group, atrial and ventricular sensing and pacing with a single lead is possible under consideration of an atrial pacing dysfunction in 17% of patients.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1046/j.1460-9592.2001.00416.x
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  • 9
    Electronic Resource
    Electronic Resource
    Incidence of Complications in Patients with Implantable Cardioverter/Defibrillator Who Receive Additional Transvenous Pace/Sense Leads (2005)
    350 Main Street , Malden , MA 02148-5018 , USA and 9600 Garsington Road , Oxford OX4 2DQ , UK . : Blackwell Science Inc
    Pacing and clinical electrophysiology 28 (2005), S. 0 
    Details
    ISSN: 1540-8159
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Background: Implantation of an additional pace/sense (P/S) lead is commonly used in patients with implantable cardioverter/defibrillators (ICDs) to overcome P/S defects of integrated defibrillation leads (HV-P/S leads). No information is available about the clinical outcome and the incidence of complications in these patients. Methods: Retrospective analysis was performed in 151 patients (125 male, age 54.9 ± 13.6 years, LVEF 48.1 ± 17.8%, CAD in 86 [57%], DCM in 24 [16%], ARVCM in 11 [7%]) who received an additional P/S lead between 1990 and 2002 (54 patients with abdominal and 97 patients with pectoral ICD system). Statistical analysis was done using Kaplan-Meier survival curves. Results: The average follow-up (FU) after implantation of the additional P/S lead was 43 ± 27 months. In total 117 patients [77.5%] remain implanted; 22 patients died due to cardiac-related reasons. After a FU of 23 ± 23 months, 43 patients [28.5%] experienced lead-related problems after implantation of the additional P/S lead: oversensing in 23 [53.5%], insulation defect in 3 [7.0%], fracture in 1 [2.3%], system infection in 4 [9.3%], and defect of the HV-P/S lead in 6 [14.0%] patients. The event-free cumulative survival of the additional P/S lead after 1, 2, and 5 years was 87.0%, 79.8%, and 59.4%, respectively (for pectoral leads: 89.6%, 82.0%, and 60.0%, respectively). Conclusions: Implantation of an additional P/S lead in case of failure of an HV-P/S lead is safe. However, it is associated with a substantial rate of complications during FU. Therefore, extraction of damaged defibrillation leads instead of implantation of P/S leads should be favored.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1111/j.1540-8159.2005.00169.x
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  • 10
    Electronic Resource
    Electronic Resource
    European Clinical Experience with a Dual Chamber Single Pass Sensing and Pacing Defibrillation Lead (2002)
    Oxford, UK : Blackwell Futura Publishing, Inc.
    Pacing and clinical electrophysiology 25 (2002), S. 0 
    Details
    ISSN: 1540-8159
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: GRADAUS, R., et al.: European Clinical Experience with a Dual Chamber Single Pass Sensing and Pacing Defibrillation Lead. Dual chamber ICDs are increasingly implanted nowadays, mainly to improve discrimination between supraventricular and ventricular arrhythmias but also to maintain AV synchrony in patients with bradycardia. The aim of this study was to investigate a new single pass right ventricular defibrillation lead capable of true bipolar sensing and pacing in the right atrium and integrated bipolar sensing and pacing in the right ventricle. The performance of the lead was evaluated in 57 patients (age 61 ± 12 years; New York Heart Association 1.9 ± 0.6, left ventricular ejection fraction 0.38 ± 0.15) at implant, at prehospital discharge, and during a 1-year follow-up. Sensing and pacing behavior of the lead was evaluated in six different body positions. In four patients, no stable position of the atrial electrode could intraoperatively be found. The intraoperative atrial sensing was 2.3 ± 1.6 mV and the atrial pacing threshold 0.8 ± 0.5 V at 0.5 ms. At follow-up, the atrial sensing ranged from 1.5 mV to 2.2 mV and the atrial pacing threshold product from 0.8 to 1.7 V/ms. In 11 patients, an intermittent atrial sensing problem and in 24 patients an atrial pacing dysfunction were observed in at least one body position. In 565 episodes, a sensitivity of 100% and a specificity of 96.5% were found for ventricular arrhythmias. In conclusion, this single pass defibrillation lead performed well as a VDD lead and for dual chamber arrhythmia discrimination. However, loss of atrial capture in 45% of patients preclude its use in patients depending on atrial pacing.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1046/j.1460-9592.2002.01079.x
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