Safety and Effectiveness of Transvenous Lead Extraction in Octogenarians

Transvenous Lead Extraction . Introduction: As the population ages, the number of elderly patients with implantable cardiac devices referred for transvenous lead extraction will dramatically increase in Western countries. The safety and effectiveness of lead extraction in elderly patients has not been well evaluated. We report the safety and effectiveness of transvenous lead extraction in octogenarians. Methods and Results: From January 2005 to January 2011, we reviewed data from consecutive patients ≥ 80 years referred to our institutions for transvenous lead extraction because of cardiac device infection or lead malfunction. Clinical characteristics, procedural features, and periprocedural major and minor complications were compared between octogenarians and younger patients. Out of 849 patients undergoing lead extraction in the participating institutions during the study period, 150 (18%) patients were octogenarians (mean age 84 years; range 80–96; 64% males). A significantly higher percentage of octogenarians presented with chronic renal failure (55% vs 26%; P < 0.001), history of malignancy (22% vs 6%; P < 0.001), and chronic obstructive pulmonary disease (46% vs 19%; P < 0.001). Complete lead extraction rates were similar in the 2 age groups (97% in octogenarians vs 96% in patients <80 years; P = 0.39). Periprocedural death occurred in 2 (1.3%) patients ≥80 years and in 5 (0.72%) patients <80 years (P = 0.45 for comparison). No differences in terms of other periprocedural major and minor complications were found between the 2 age groups. Conclusion: Despite presenting with a significantly higher rate of comorbidities, transvenous lead extraction can be performed safely and successfully in octogenarians. (J Cardiovasc Electrophysiol, Vol. 23 pp. 1103‐1108, October 2012)     

A Novel Indication for Transvenous Lead Extraction: Upgrading Implantable Cardioverter Defibrillator Systems

Technological advances have resulted in the development of dual chamber pacemaker/defibrillator systems with smaller pectoral 'active cans'. Patients now have the option of upgrading from abdominal to pectoral or from single to dual chamber devices. In addition, due to the potential complications which may arise with abandoned ICD leads, extraction of preexisting leads may be preferable.Methods and Results: Twenty consecutive patients (11 males), underwent lead extraction and upgrade, either from an abdominal to a pectoral, or from a single to a dual chamber device. The mean age was 62±18[emsp4 ]years and mean implant duration was 50±14 months. Indications for extraction included lead fracture/malfunction (13), ERI/EOL (2), new SVT/VT (2), long charge times (2), and impending erosion (1). An initial attempt was made to remove the lead with gentle traction. If excessive scar tissue prohibited extraction, then a laser sheath was employed. Reimplantation proceeded following standard protocol.Clinical success was achieved in all patients. Eleven of thirty leads were removed with traction. The remaining 19 leads required removal with the laser sheath. All ICD reimplants were placed in the left pectoral position, of which 10 were dual chamber. The mean defibrillation threshold was 9.5±5.8 Joules. There were no procedure related perforations or deaths. At follow up (13±10 mos.) there were no infections, lead malfunctions or venous thromboses. There were two deaths, both from intractable heart failure.Conclusions: This study demonstrates that, when indicated, ICD leads can be safely extracted and systems successfully upgraded to take advantage of new technology.     

Transvenous Defibrillation Lead Systems

Transvenous Defibrillation. The use of the implantable cardioverter defibrillator has grown dramatically over the past 10 years. One of the major advances in defibrillation technology is the development of transvenous lead systems. Compared with traditional epicardial lead systems, transvenous defibrillation leads reduce perioperative mortality, hospitalization, and costs. Transvenous lead systems provide reliable sensing of ventricular tachyarrhythmias, although redetection of ventricular fibrillation can be prolonged, especially with integrated lead systems. Both ramp and burst adaptive pacing are equally effective for the termination of ventricular tachycardia and are successful in up to 90% of spontaneous events. Defibrillation thresholds are higher with transvenous leads than with epicardial patches. These thresholds are reduced with the use of multiple transvenous leads, subcutaneous patches, or with reversing shock polarity. However, the development of biphasic waveforms has made the largest impact on the efficacy of these lead systems, allowing dual coil transvenous systems to be effective in about 90% of patients. Defibrillation efficacy is further enhanced and implantation simplified by the incorporation of an active pulse generator located in the left pectoral region. Active pectoral pulse generators with biphasic waveforms will be the primary lead system for new implants.     

Lead Thrombi Associated with Externalized Cables on Riata ICD Leads: A Case Series

St. Jude Riata family ICD leads are subject to an FDA class I recall due to insulation failure, cable extrusions, and a high rate of electrical failures. We present multiple cases of large intravascular thrombus formation adherent to externalized conductor cables on Riata leads. Our observations highlight a previously unknown risk of large or calcified thrombus formation involving externalized conductors. We suggest that these leads should be screened for thrombi prior to potential lead extraction to determine the safest approach. Serial echocardiography may help detect progressive thrombus formation. The role of systemic anticoagulation for prevention or treatment of these thrombi remains unclear.     

Inappropriate Implantable Defibrillator Discharge Caused by a Retained Pacemaker Lead Fragment

Introduction: Inappropriate discharge is still a major issue of implantable cardioverter defibrillator therapy. The diagnostic options of modern devices facilitate classification of the underlying abnormality.Methods and Results: A 65-year-old woman with depressed left ventricular performance received spurious shocks from an ICD, implanted for ventricular tachycardia. A lead fragment of an explanted VVI pacemaker system could be identified as cause of erroneous ventricular fibrillation detection by the ICD. The electrical noise caused by interaction between the lead remnant and the ICD lead was detectable even on the surface ECG.Conclusion: Based on our findings, removal of fragmented lead material should be considered prior to ICD implantation, to avoid potentially adverse and harmful interactions with ICD systems.     

Risk Factors for Implantable Defibrillator Lead Fracture in a Recalled and a Nonrecalled Lead

Risk Factors for ICD Lead Fracture. Introduction: The Medtronic Sprint Fidelis® implantable cardioverter defibrillator (ICD) lead was “recalled” in October 2007 after 268,000 implants worldwide due to increased failure risk. Manufacturer suggested monitoring has not been shown effective at preventing adverse events. Only limited data exist regarding clinical predictors of Fidelis® lead fracture. We sought to identify risk factors for Fidelis® fracture to guide clinical monitoring and compare its performance with a control lead. Methods: Fractured lead cases were retrospectively reviewed for demographic data, implant technique, radiographic appearance and clinical presentation was analyzed. Lead survival was compared using Kaplan‐Meir curves. Results: Study patients (n = 1314) experienced 18 Fidelis® and 6 Quattro? lead fractures. Patients with failed Fidelis® leads were younger than those with surviving leads (49.5 vs 64.6 years, P = 0.0066). Fidelis® lead fractures often occurred around the time of physical activity. No other measured demographic or technique related factors were associated with lead fracture. Fidelis® leads had significantly decreased survival compared with Quattro? leads (89.3 vs 98.9% at 30 months). Patients less than 50 years old had significantly decreased lead survival compared with those older than 50 in both Fidelis® (79.6% vs 96.5% at 24 months) and Quattro? (93.4 vs 99.8%, P < 0.001 at 24 months) leads. Conclusions: Patients under age 50, with either Fidelis® or Quattro? ICD leads, are at increased risk of lead fracture compared with patients over 50, particularly around the time of intense physical activity. Aggressive monitoring and advisory programming appears warranted in patients with Fidelis® leads as well as especially in younger patients. (J Cardiovasc Electrophysiol, Vol. 21, pp. 671‐677, June 2010)     

Sudden Death in Recipients of Transvenous Implantable Cardioverter Defibrillator Systems:

INTRODUCTION: Transvenous implantable cardioverter defibrillator (ICD) systems are very effective in preventing sudden death; however, little is known about terminal events and potential causes and mechanisms of sudden death in recipients of these devices. METHODS AND RESULTS: We analyzed 74 cases of sudden death among patients enrolled in several clinical investigations of transvenous ICD systems. Eighty-one percent were men (mean age 68+/-10 years), 86% had coronary artery disease, mean left ventricular ejection fraction was 0.27+/-0.11, and two thirds presented with sustained ventricular tachycardia. The final event was witnessed in 65 patients (81%). Based on reported ICD shocks, documented rhythm, and/or postmortem device data, sudden death was deemed tachyarrhythmic in 49 cases (66%), nontachyarrhythmic in 12 (16%), and indeterminate in the remaining 13 (18%). Multivariate analysis of several clinical and nonclinical factors found advanced age (> 65 years, P = 0.03, odds ratio [OR] 1.75, 95 % confidence interval [CI] 1.05 to 2.92), reduced left ventricular ejection fraction (< 0.35, P < 0.01, OR 3.51, CI 1.66 to 7.40), and having antibradycardia pacing ICDs (P = 0.02, OR 5.26, CI 1.37 to 20.0) to be independent predictors of sudden death. One or more predisposing factors and/or potential causes of sudden death were identified in 21 patients (28%). CONCLUSION: In this select group of transvenous ICD recipients, (1) sudden death was associated with ventricular tachycardia/ventricular fibrillation in at least two thirds of cases, (2) nearly one third of patients had one or more factors, some device related, that could have been associated with sudden death, and (3) death ensued despite appropriate ICD therapies and, in many cases, external resuscitation, suggesting acute adverse events as common terminal factors.     

Safe Extraction of Riata Looped Extruding Filler Cables

The Riata 1590 lead model contains both electrically active cables (AC) and filler cables (FC) that run in pairs within lumens along the lead body. FC are yet to be described as lead components that may be externalized from either external abrasion or inside‐out abrasion seen in the recalled St. Jude leads. Externalization of FC would not be expected to develop any electrical abnormality during routine ICD and lead evaluations. FC are fixed at their ends only with a silicone adhesive compared to mechanical crimps for AC. This glue bond can break allowing a progressive migration of the filler cable to extrude out the insulation breach forming profound loops of cables. We identify the 10 recalled Riata models that contain the electrically inactive FC that will need closer scrutiny by X‐ray imaging techniques. Extraction of ICD leads with externalized cables may be difficult, with the presence of extruded loops of FC compounding procedural complexity. We describe a technique that reduced extruded loops of FC and allowed safe extraction of the lead.