Transvenous defibrillation leads: high incidence of failure during long-term follow-up

INTRODUCTION: Patients with implantable cardioverter defibrillators (ICD) critically depend on correct functioning of their system. The aim of this study was to determine the incidence and clinical presentation of transvenous ICD lead failures during long-term follow-up. METHODS AND RESULTS: The study group consisted of 261 consecutive patients who received Medtronic right ventricular polyurethane transvenous leads (models 6884, 6966, 6936) between 1990 and 1998 as part of an abdominal (n = 70) or pectoral (n = 191) ICD system. During mean follow-up of 4.0 +/- 2.6 years, 31 patients (12%) developed a lead-related sensing failure with oversensing of artifacts. All failures except two were compatible with an insulation defect and occurred late after ICD placement (6.0 +/- 1.8 years after implant). Lead survival decreased from 98% at 4-year follow-up to only 62% at 8-year follow-up. Lead survival was not related to patient age, sex, venous lead implantation route, or device implantation site. In 26 (87%) of 31 patients, a sensing defect resulted in inappropriate detection of ventricular fibrillation and subsequent delivery of 3 +/- 3 (range 1-11) inappropriate shocks in 19 (61%) of 31 patients. Device interrogation showed artifacts classified as nonsustained ventricular tachycardia in 21 patients, 40 +/- 43 days before clinically relevant failure of the system. One patient with a subclavian crush syndrome required resuscitation because of undersensing of true ventricular fibrillation. CONCLUSION: Transvenous polyurethane ICD leads showed a high rate of lead insulation failure late after implantation with frequent inappropriate shock deliveries. Close follow-up is mandatory in patients with these leads. Automated device control features with patient alert function integrated into new devices may contribute to early detection of lead failure.     

Detection and management of an implantable cardioverter defibrillator lead failure: incidence and clinical implications

OBJECTIVES: This study evaluated the long-term reliability of an implantable cardioverter defibrillator (ICD) lead to determine the incidence, clinical presentation, and management of lead failure. BACKGROUND: Despite recent advances in ICD technology, the long-term reliability of ICD leads remains a significant problem. METHODS: Concern about long-term reliability of coaxial polyurethane ICD leads caused us to systematically study all patients implanted with Medtronic (Minneapolis, Minnesota) 6936 lead at our institution. We performed follow-up of 74 patients with 76 ICD leads that were implanted from February 28, 1995 to September 8, 1997. Thirty-seven patients underwent routine clinical ICD follow-up testing and ventricular fibrillation induction to determine the status of their ICD lead after a mean follow-up of 68.6 +/- 8.2 months. RESULTS: The lead survival analysis shows a cumulative failure probability of 37% (confidence interval, 24% to 54%) at 68.6 months. Six patients demonstrated a previously undescribed mode of ICD lead failure: prolonged oversensing immediately after shock therapy. The use of short interval counters to monitor nonphysiologic R-R intervals and the measurement of ring-to-coil impedance detected early lead failures in five patients. CONCLUSIONS: This analysis shows: 1) problems with ICD leads may not become apparent until late during follow-up and may become a significant late problem, 2) a "signature" mode of lead failure for the 6936 consisting of oversensing of electrical noise following shocks, 3) early detection of lead failure with a short interval counter algorithm or measurement of ring-to-coil impedance may be clinically useful.     

Incidence of venous obstruction following insertion of an implantable cardioverter defibrillator. A study of systematic contrast venography on patients presenting for their first elective ICD generator replacement.

AIMS: The number of implantable cardioverter defibrillator (ICD) implantations, as well as follow-up procedures such as generator exchanges, lead revisions and lead system upgrades, is ever-increasing. Lead revisions and implantation of additional leads require venous access at the site of the previous ICD implantation. The aim of our study was therefore to evaluate the incidence of venous obstruction after chronic transvenous ICD system implantation. METHODS AND RESULTS: One hundred and five consecutive patients admitted for their first elective ICD generator replacement were included. All patients underwent bilateral contrast venography and the images were analyzed by two attending radiologists. Venous obstruction was classified as moderate stenosis (50-75% diameter reduction), severe stenosis (>75%) or total occlusion. Venous obstruction of various degrees was found in 25% of the patients. Complete occlusion was found in 9%, severe stenosis in 6% and moderate stenosis in 10% of the patients. The incidence of venous obstruction was increased in patients with a pacemaker prior to the initial ICD system implantation (67%). No difference was found in patients with a single defibrillator lead compared with patients who had an additional superior vena cava (SVC) shocking coil. However, the presence of a second shocking coil in the SVC incorporated in a single ICD lead was associated with an increased incidence of venous obstruction. No difference was found between silicone and polyurethane insulated leads. CONCLUSION: This study shows that venous obstruction occurs relatively frequently after ICD implantation. Therefore, contrast venography should always be obtained if malfunction of a preexistent lead is suspected or a system upgrade is considered.     

A multicenter experience with novel implantable cardioverter defibrillator configurations in the pediatric and congenital heart disease population

INTRODUCTION: In pediatric and congenital heart disease patients, transvenous ICD implantation may be limited secondary to patient size, venous, or cardiac anatomy. Epicardial patches require a thoracotomy, and may lead to a restrictive pericardial process. Because of these issues, we have explored novel ICD configurations. METHODS: Retrospective review at 10 centers implanting ICDs without a transvenous shocking coil or epicardial patches. RESULTS: Twenty-two patients underwent implant at a mean age of 8.9 years (range: 0.3-43.5), with a mean weight of 25.5 kg (range: 5.2-70). Diagnoses included complex CHD, intracardiac tumors, cardiomyopathy, idiopathic VT, LV noncompaction, and long QT syndrome. Three configurations were used: subcutaneous array, a transvenous design ICD lead placed on the epicardium, or a transvenous design ICD lead placed subcutaneously. Difficulties were found at implant in 8 patients: 4 had difficulty inducing VT/VF, and 4 had high DFTs. Over a mean follow-up of 2.2 years (range: 0.2-10.5), 7 patients had appropriate shocks. Inappropriate shocks occurred in 4 patients. System revisions were required in 7 patients: 2 generator changes (in 1 patient), 3 pace-sense lead replacement, 1 additional subcutaneous coil placement due to increased DFT, 1 upgrade to a transvenous system, and 1 revision to epicardial patch system. CONCLUSIONS: ICD implantation can be performed without epicardial patches or transvenous high-energy leads in this population, using individualized techniques. This will allow ICD use in patients who have intracardiac shunting or are deemed too small for transvenous ICD leads. The long-term outcome and possible complications are as yet unknown in this population, and they should be monitored closely with follow-up DFTs.     

Experience of cardioverter-defibrillators inserted without thoracotomy: evaluation of transvenously inserted intracardiac leads alone or with a subcutaneous axillary patch.

OBJECTIVES--To compare the efficacy of a purely transvenous cardioverter-defibrillator (ICD) system with that of a system with a supplementary subcutaneous patch. To evaluate clinical follow up of these lead arrangements that do not require thoracotomy. DESIGN--A simplified defibrillation protocol to test two different lead arrangements during implantation, with routine clinical follow up after implantation. SETTING--Tertiary referral centre for treatment of arrhythmia. PATIENTS--22 consecutive patients selected for implantation of an ICD because of life-threatening ventricular arrhythmias (ventricular fibrillation or sustained ventricular tachycardia) of whom 20 entered the test protocol. INTERVENTION--Implantation of an ICD with transvenously inserted intracardiac leads and a subcutaneous patch and assessment of effective defibrillation followed by testing of the purely transvenous approach. MAIN OUTCOME MEASURES--Reproducible conversion of ventricular fibrillation to sinus rhythm at a certain energy level, providing a safety margin of at least 10 J for both lead arrangements. Confirmation of efficacy during clinical follow up (mean 6 months). RESULTS--A transvenous lead system combined with a subcutaneous axillary patch was implanted in 20/22 patients and it provided adequate and acceptable energy levels. In 10/20 tested patients a purely transvenous lead configuration provided an acceptable safety margin as well. Nine patients had clinical recurrences: all these arrhythmias were successfully converted. CONCLUSION--A transvenous lead system was sufficient in 50% of the patients at the time of implantation. Data on long-term clinical follow up of this arrangement are not available. The approach without thoracotomy with a subcutaneous patch is feasible and effective in most patients selected for ICD treatment.     

Transvenous ICD implantation after artificial tricuspid valve replacement A new approach placing a transvenous ICD lead in the mid cardiac vein of the coronary sinus

Implantation of a transvenous device in patients with a tricuspid valve replacement or a complex congenital heart disease with no access to the right ventricle represents problems. The lack of access to the right ventricle might preclude transvenous placement of a defibrillation lead at ICD implantation. A young patient (21 years) with a history of severe chest trauma with rupture of the tricuspid valve as well as the right coronary artery and consecutive inferior myocardial infarction was initially treated with tricuspid valve replacement (St Jude Medical artificial prosthesis, 33 mm) and a bypass graft to the right coronary artery. Four years later, the patient was admitted with a hemodynamically not tolerated ventricular tachycardia (VT: CL 250 ms, LBBB, left axis). The VT could be reproduced during electrophysiological testing. An ICD was implanted subpectorally in combination with a transvenous active fixation ICD lead. The transvenous ICD lead was placed via a guiding catheter into a coronary sinus branch (middle cardiac vein). Acceptable pacing and sensing values could be obtained. The defibrillation threshold was 25 J. In conclusion transvenous ICD lead implantation into a side branch of the coronary sinus in combination with a pectorally implanted “active can” ICD device seems to be an alternative approach. This approach may avoid implantation of additional subcutaneous defibrillation leads or even thoracotomy for ICD implantation.     

Patient, procedural, and hardware factors associated with pacemaker lead failures in pediatrics and congenital heart disease

OBJECTIVES: To examine outcomes of children with pacemakers over a 22-year period and identify risk factors for lead failure. BACKGROUND: Small patient size, structural cardiac abnormalities, and growth may complicate pediatric pacemaker management. Better knowledge of risk factors for lead failure in these patients may help improve future outcomes. METHODS: All pacemaker patients followed at one pediatric center 1980-2002 were included. Lead failures were identified retrospectively as leads repaired, replaced, or abandoned due to fracture, insulation break, dislodgement, or abnormalities in pacing or sensing. Risk factors were identified using logistic regression and Cox analyses. RESULTS: A total of 1007 leads were implanted in 497 patients during the study period (5175 lead-years). Median age at implant was 9 years (0-55); 64% of patients had structural congenital heart disease. Median follow-up time was 6.2 years (0-22). Lead failure occurred in 155 leads (15%), and 115 patients (23%), with 28% of patients experiencing multiple failures. Significant independent correlates of lead failure included age <12 years at implant, history of structural congenital heart defects, and epicardial lead placement. Younger patients (<12 years) experienced significantly more lead fractures than older children (P = .005), while patients with congenital heart defects experienced more exit block. Epicardial leads were more likely to fail due to fracture or exit block, while transvenous leads failed more due to insulation breaks or dislodgements. CONCLUSIONS: Pediatric pacing patients have a high incidence lead failures. These occur most commonly in younger patients, structural congenital heart disease, and those with epicardial lead systems. Approaches to pacing system implantation and follow-up in these patients need to be individualized, with special attention to minimizing risk of lead failures. Our findings suggest that expanded utilization of transvenous systems in smaller patients seems justified when anatomy permits.     

植入型心律转复除颤器导线故障分析

目的总结分析我院植入型心律转复除颤器（ICD）起搏除颤导线故障病例特点。方法对2005年10月至2009年12月62例在我院新植入ICD导线患者进行随访分析,所有导线植入均以锁骨下静脉作为入路。随访中出现以下1项或多项异常考虑导线故障：（1）起搏阻抗永久性或间歇性〉2000n或〈250Q;（2）除颤高压阻抗〉200n;（3）心内电图证实除颤导线感知非生理性高频噪声导致误放电。结果中位数随访时间28（10～46）个月,4例患者（6．5％）诊断ICD导线故障,导线寿命18～38个月;临床均以ICD误放电至医院就诊,同时程控发现ICD导线起搏阻抗异常。其中1例患者放电前闻及ICD导线阻抗报警,4例患者均重新植入新的起搏感知导线。结论ICD导线故障是一个值得重视的临床问题。ICD导线阻抗报警功能可能有助于早期发现导线故障。如程控发现仅仅除颤导线起搏阻抗异常,植入新的起搏感知导线可以作为首选的故障处理方法。     

Transvenous ICD implantation after artificial tricuspid valve replacement. A new approach placing a transvenous ICD lead in the mid cardiac vein of the coronary sinus

Summary Implantation of a transvenous device in patients with a tricuspid valve replacement or a complex congenital heart disease with no access to the right ventricle represents problems. The lack of access to the right ventricle might preclude transvenous placement of a defibrillation lead at ICD implantation. A young patient (21 years) with a history of severe chest trauma with rupture of the tricuspid valve as well as the right coronary artery and consecutive inferior myocardial infarction was initially treated with tricuspid valve replacement (St Jude Medical artificial prosthesis, 33 mm) and a bypass graft to the right coronary artery. Four years later, the patient was admitted with a hemodynamically not tolerated ventricular tachycardia (VT: CL 250 ms, LBBB, left axis). The VT could be reproduced during electrophysiological testing. An ICD was implanted subpectorally in combination with a transvenous active fixation ICD lead. The transvenous ICD lead was placed via a guiding catheter into a coronary sinus branch (middle cardiac vein). Acceptable pacing and sensing values could be obtained. The defibrillation threshold was 25 J. In conclusion transvenous ICD lead implantation into a side branch of the coronary sinus in combination with a pectorally implanted “active can” ICD device seems to be an alternative approach. This approach may avoid implantation of additional subcutaneous defibrillation leads or even thoracotomy for ICD implantation.     

Adverse events with transvenous left ventricular pacing in patients with severe heart failure: early experience from a single centre.

AIMS: Assessment of complications following implantation of transvenous ventricular electrodes to pace the left ventricle. METHODS AND RESULTS: Twenty-eight patients with severe cardiac failure and left bundle branch block were prospectively followed for adverse effects of implantation of a left ventricular transvenous pacing system. Immediate follow-up was associated with loss of left ventricular pacing in nine patients (32%). This was due to lead dislodgement in four cases (corrected by re-operation in three of these cases), and due to increased threshold in five cases (corrected by programming a higher pacing amplitude in all five cases, but with intermittent diaphragmatic contraction in one case). After 1 month, one patient died, one patient with severe coronary heart disease suffered a myocardial infarction, and left ventricular pacing was lost in two patients. Pericardial effusion, new significant ventricular arrhythmias or other adverse effects were not observed. After a mean follow-up of 16 +/- 9.2 months, pacing leads remained stable and no late complications related to the transvenous left ventricular epicardial pacing were observed. CONCLUSION: Placement of a permanent lead in a tributary of the coronary sinus is feasible without serious adverse effects during the first month. The only frequent adverse event was lead dislodgement; a finding which emphasizes the need for development of specially designed leads for this application.     

Implantable cardioverter defibrillator (ICD) in children

BACKGROUND: Implantable cardioverter defibrillators (ICD) proved to be effective in the prevention of sudden cardiac death in adults. In children, the experience of ICD therapy is limited. This retrospective study was undertaken to review our experience with ICD implantation in children with special consideration of psychosocial impact of this therapy. METHODS AND RESULTS: Sixteen children (f:5, m:11, median age 12.2 years, range 4-15.9 years) received an ICD. Eleven patients had survived sudden cardiac death with documented ventricular fibrillation (VF) and five patients had sustained ventricular tachycardia (VT) with hemodynamic significance. The underlying heart disease was congenital in 5, hypertrophic cardiomyopathy in 2, myocarditis in 2 and primary electrical in 7 patients. All leads were implanted transvenously. Mean follow up was 43.1 months (range 1-105 months). All patients are alive. In 7 patients, a total of 387 sustained VT episodes were detected by the ICD. At follow-up, 10 inappropriate shocks were delivered in four patients. One early and six late lead revisions were done in seven patients. 12/16 (75%) patients had concomitant antiarrhythmic drug therapy. About half of the adolescents showed signs of depression and/or anxiety. CONCLUSION: ICD therapy via transvenous access for prevention of sudden cardiac death is feasible and effective even in small children. However, the occurrence of lead complications is significant. Since about half of the adolescents showed signs of depression and/or anxiety, professional psychological surveillance should be considered in these patients.     

Transvenous defibrillator systems implanted by electrophysiologists in the catheterization laboratory

Background: A significantly lower perioperative mortality has established the nonthoracotomy approach as the preferred technique in implantable cardioverter defibrillation (ICD) implantation. With the currently available transvenous endocardial leads in combination with the expanded use of biphasic ICD devices, the need for use of an additional subcutaneous lead has almost been eliminated. Thus, implantation of these systems has been simplified and reports have appeared in the literature that the procedure can now be performed by an electrophysiologist alone without surgical assistance in the electrophysiology or catheterization laboratory. Hypothesis: The purpose of this study was to investigate the feasibility and safety of ICD implantation by an electrophysiologist in a procedure performed entirely in the catheterization laboratory without the assistance of a surgeon. Methods: Over a period of 28 months, we implanted transvenous ICDs in 40 consecutive patients with (n = 34) and without (n = 6) use of general anesthesia in the catheterization laboratory with minor surgical assistance in abdominal pocket fashioning for the first two cases and then working alone for the remainder. The study included 36 men and 4 women, aged 59 ± 12.5 years, with coronary artery (n = 22) or valvular heart disease (n = 4), cardiomyopathy (n = 12), and long QT syndrome (n = 1) or idiopathic ventricular tachycardia (n = 1), and a mean left ventricular ejection fraction of 34%, who presented with ventricular tachycardia (n=30) or ventricular fibrillation (n= 10). Results: One-lead ICD systems (Endotak®, n = 21; Transvene®, n = 8; or EnGuard®, n = 1) were used in 30 patients, and 2-lead (EnGuard, n = 5 or Transvene, n = 5) systems in 10 patients. Generators were implanted in an abdominal (n = 17) or pectoral (n = 23) pocket. Active can devices were employed in 17 patients. The defibrillation threshold averaged 9 J. All implants were entirely transvenous with no subcutaneous patch. Biphasic ICD devices were employed in all patients. There were three complications (8%): one pulmonary edema that responded to drug therapy, one lead insulation break that required reoperation on the third day, and one pocket hematoma in a patient receiving anticoagulation, with no need for evacuation. There were no operative deaths and no infections. After implant, patients were discharged at a mean of 3 days. All devices functioned well at predischarge testing. During follow-up (12 ± 8 months), 20 patients received appropriate and 5 patients inappropriate shocks. Three patients died of pump failure at 3,7, and 19 months, respectively; they had received 0,42, and 15 appropriate shocks, respectively, over these months. Another patient succumbed to a myocardial infarction at 9 months. At 6 months, one patient developed subacute subclavian vein thrombosis which resolved with anticoagulation therapy. Conclusions: Current transvenous biphasic ICD systems allow experienced electrophysiologists to implant them safely alone in the catheterization laboratory without surgical assistance, even for abdominal implants, with a high success rate and no need for use of a subcutaneous patch.     

Biventricular implantable cardioverter defibrillator use in a patient with heart failure and ventricular tachycardia secondary to Emery-Dreifuss syndrome.

We report a case of fully transvenous single-unit biventricular implantable cardioverter defibrillator (ICD) use in a 43-year-old woman with a manifesting carrier form of muscular dystrophy (Emery-Dreifuss syndrome). The indication for biventricular ICD use was progressive heart failure with ventricular arrhythmia, permanent atrial fibrillation and previous VVIR pacemaker insertion. Single-unit transvenous biventricular ICD implantation was undertaken without complication. No potentially serious device malfunction was noted during subsequent follow-up. We conclude that single-unit biventricular ICD implantation is feasible for pacing and ventricular tachyarrhythmia control in patients with underlying atrial fibrillation.     

Sprint fidelis defibrillation lead: a nine-center experience in Spain

Introduction and objectives

Sprint Fidelis defibrillation leads are prone to early failure. Most of the reported series come from a single institution. This paper describes the clinical experience in nine Spanish hospitals.

Methods

Clinical, implant, and follow-up data of all patients with a Sprint Fidelis lead were analyzed. All cases of lead failure were identified, medium-term lead survival was calculated, and possible predictors for lead failure were determined.

Results

In total, 378 leads in 376 patients were studied. The mean age (male 85.7%) was 64.9±13.6 years. The majority of patients (59.8%) had ischemic heart disease. Mean left ventricular ejection fraction was 33.4%±14.5%. Left subclavian vein puncture was used in 74.8%. During a mean follow-up of 30.9±14 months, 16 lead failures have occurred, with a lead survival of 96.1% at 36 months after implantation. Eleven of 16 lead failures were caused by failure of pace/sense conductors, 3 by defects in the high-voltage conductor, and 2 by defects in both types of conductors. A less depressed left ventricular ejection fraction was associated with an increased probability of lead failure (42.4%±16% vs. 33%±14.3%; P=.011). Three hospitals presented a rate of lead failure higher than 10%; the rate was less than 5% in the remaining 6 hospitals.

Conclusions

In this multicenter series of 378 leads, the 3-year estimated survival was higher than that reported in prior series. Clinical presentation of lead failures was similar to that reported previously. Left ventricular ejection fraction and hospital of implantation were variables associated to lead failure.Full English text available from: www.revespcardiol.org     

Sensing lead failure in implantable defibrillators: a comparison of two commonly used leads

INTRODUCTION: Despite major technological advances, structural problems in implantable cardioverter defibrillator (ICD) endocardial sensing leads remain a significant problem. There are two types of ICD sensing leads: (1) dedicated bipolar leads and (2) integrated lead systems that include defibrillation coils. The long-term performance of these two lead systems has not been directly compared. METHODS AND RESULTS: We prospectively examined the incidence of lead failure manifested by inappropriate arrhythmia detection in 247 consecutive patients undergoing abdominal ICD implant at a single center between 1991 and 1995. A total of 107 patients received BT-10 (dedicated bipolar) leads and 140 patients received Endotak (integrated bipolar) leads. Over a mean follow-up of 860 +/- 442 days, there were 19 (17.8%) lead failures with the BT-10 lead (261 to 1,505 days postimplant) compared with only 6 (4.3%; P < 0.01) with the Endotak lead (410 to 1,211 days postimplant). Lead failure was due to an insulation defect in all cases, with the problem occurring in the proximal lead (within the pulse generator pocket) in all but one case. Lead survival was significantly better with the Endotak lead (P = 0.015, risk ratio = 3.0, 95% confidence intervals 1.2 to 7.6). CONCLUSION: Late lead failure due to insulation defects in BT-10 sensing leads (causing inappropriate ICD activation) is a relatively common and progressive phenomenon, with difficulties becoming apparent as long as 4 years after implant. This problem is a likely cause of inappropriate shocks in patients with BT-10 leads. Implantation of a new sensing lead should be considered at the time of elective pulse generator replacement, even in the absence of demonstrable oversensing.     

The use of implantable cardioverter-defibrillators in pediatric patients awaiting heart transplantation

BACKGROUND: This multicenter study evaluated experience with implantable cardioverter defibrillators (ICD) as a bridge to orthotopic heart transplantation (OHT) in children. METHODS: The application of ICD therapy continues to expand in pediatric populations, due in part to improved technology and new indications, including the prevention of sudden death while awaiting OHT. METHODS: We performed a retrospective review of ICD databases at 9 pediatric transplant centers. RESULTS: Twenty-eight patients (16 males) underwent implantation or had a preexisting ICD while awaiting OHT between 1990 and 2002. The median age at implant was 14.3 years (11 months to 21 years) with a median weight of 49 kg (11.7-88 kg). Diagnoses included cardiomyopathy (n=22), and congenital heart disease (n=6). Indications for ICD implantation included ventricular tachycardia/fibrillation (n=23), syncope (n=5), aborted sudden death with no documentation of rhythm disturbance (n=5), ventricular ectopy (n=1), and poor function (n=5). Of the 28 ICDs, 23 were implanted by a transvenous approach and 5 by epicardial route. There were 55 defibrillator discharges in 17 patients, 47 (85%) of which (in 13 patients) were appropriate. The 8 inappropriate discharges (in 6 patients) were triggered by sinus tachycardia, inappropriate sensing, and atrial flutter. The mean time from implantation to first appropriate shock was 6.9 months (1 day to 2.6 years). Twenty-one patients underwent transplantation during the study period, whereas 2 died while awaiting a donor. Morbidity included a lead fracture, 3 episodes of electromechanical dissociation, and 1 episode of electrical storm. CONCLUSIONS: ICD implantation represents an effective bridge to transplantation in pediatric patients. The complication rate is low, with inappropriate device discharge due primarily to sinus tachycardia or atrial flutter. There is a high incidence of appropriate ICD therapy for malignant ventricular arrhythmias in this highly selected group of patients.     

A permanent transvenous lead system for an implantable pacemaker cardioverter-defibrillator. Nonthoracotomy approach to implantation.

A transvenous lead system for implantable defibrillators would obviate a surgical thoracotomy and reduce the morbidity and mortality associated with implantation. We evaluated the clinical performance of a new nonthoracotomy lead system that included a defibrillation lead in the coronary sinus. At the time of defibrillator implantation, transvenous defibrillation leads were inserted percutaneously through the left subclavian vein into the right ventricular apex (RVA), superior vena cava (SVC), and distal coronary sinus (CS) under fluoroscopic guidance. A subcutaneous patch electrode (SQ) was also available if required. The first single- or dual-pathway electrode configuration that successfully terminated three of four ventricular fibrillation episodes using 18 J or less was implanted. Eleven men and three women aged 39-77 years (60.0 +/- 10.1 years) with left ventricular ejection fraction ranging from 16% to 63% (33.4 +/- 13.1%) were evaluated. Nine presented with ventricular tachycardia, three had ventricular fibrillation, and two had both. A totally transvenous lead system (RVA/CS/SVC) was implanted in seven patients (50%) with a mean defibrillation threshold of 15.6 +/- 2.9 J (10-18 J). Four patients received a partial transvenous lead system (RVA/CS/SQ). An effective nonthoracotomy lead system was not found in three patients; they received epicardial electrodes. After cumulative follow-up of 73 patient-months, nine patients remain alive and free of problems related to the implanted nonthoracotomy leads. One patient died of respiratory failure 3 months after defibrillator implant, and the leads from another patient were removed at 9 months because of bacterial infection. A transvenous lead system that includes a defibrillation lead in the coronary sinus is a safe, reliable, and, at least in the short term, effective nonthoracotomy approach for automatic defibrillator implantation.     

Limited thoracotomy as a second choice alternative to transvenous implant for cardiac resynchronisation therapy delivery.

AIMS: Left ventricular (LV) pacing via transvenous implantation has an overall success rate ranging from 88% to 92%. The aim of this study was to assess whether LV pacing via limited thoracotomy would be feasible and safe when used on a routine basis for those cases in which standard transvenous procedures proved to be ineffective or unsatisfactory. METHODS AND RESULTS: We enrolled 33 patients (8 females, 65+/-10 years) who experienced a transvenous implantation failure. All patients underwent a limited thoracotomy and an epicardial lead was implanted. The procedure time was 51+/-28 min. No surgical or post-operative complications occurred and optimal lateral position was achieved for all patients. In the 12 months follow-up period, 5 patients died from refractory heart failure, the remaining patients did not experience complications. At implant, the mean pacing threshold was 1.3+/-0.7 V, bi-ventricular pacing impedance was 476+/-201 Omega and R-wave amplitude was 15.0+/-6.1 mV. No significant differences were found in any of the electrical parameters between baseline and follow-up. Significant improvement was observed in functional and echocardiographic parameters. CONCLUSION: Our results suggest that a combined approach to cardiac resynchronisation therapy delivery, including a transvenous attempt followed by a back up thoracotomic procedure, could potentially guarantee the success.     

Extraction of endocardial implantable cardioverter-defibrillator leads.

Despite a growing number of implantable cardioverter-defibrillator (ICD) lead removal indications, there is no consensus about extraction techniques. We applied our experience of pacemaker lead removal to ICD leads using a superior approach with a standard extractor kit, and an inferior approach with a lasso, or a surgical extraction. Fifteen leads were removed in 11 patients during 12 procedures (1 patient was referred twice): 11 right ventricular defibrillation leads, 3 right atrial coils, and 1 atrial lead implanted with a DDD-ICD. The indication for lead extraction was insulation failure (n = 4), conductor fracture (n = 2), abdominal pocket infection (n = 4), lead endocarditis (n = 1), and replacement of an atrial coil by an atrial lead for DDD-R pacing (n = 1). One patient had surgical extraction of 2 leads because of an endocarditis with large vegetations on a DDD-ICD. In 11 other cases, 5 leads were removed using a superior approach with a standard extraction kit and 8 leads were removed by a femoral approach using a lasso alone or added to a pigtail catheter. There was no failure of explantation. One extraction attempt failed with the superior approach but was successful with a secondary inferior approach. The main difficulties encountered were due to tight adherence of the proximal coil to the venous wall and to dislodgment of passive fixation leads from their endocardial insertion. One patient had subclavian vein thrombosis after intervention; no major complication was noted. Ten patients immediately underwent reimplantation. Two patients (1 with an endocarditis and 1 free of ICD therapy for 5 years) did not have reimplantation. During a 4- to 44-month follow-up, no late complication appeared. Thus, ICD lead explantation can be performed with a good success rate, with extraction techniques similar to those used for pacemaker leads.     

Pacemaker and ICD lead extraction with electrosurgical dissection sheaths and standard transvenous extraction systems: results of a randomized trial.

AIMS: The purpose of this prospective randomized study was to evaluate the safety and efficacy of transvenous pacemaker and implantable cardioverter-defibrillator (ICD) lead extraction with an electrosurgical dissection sheath (EDS) system in a single-centre experience. Methods Over 10 years, 462 patients have undergone transvenous lead extraction in our institution. From these, 120 consecutive patients (with 161 leads) were randomized to either radiofrequency (RF) current supported extraction or standard countertraction lead removal (60 patients in each arm, 96 men and 24 women). The mean age of randomized patients was 62.7 +/- 9.6 years. In 16 patients, we explanted 17 ICD leads. The average time from the date of implantation to the extraction procedure was 73.4 +/- 15.7 months. The most common reason for lead extraction was infection (95.6%). Results The complete extraction of 78 leads (93%) was achieved in the RF group and 56 leads (73%) with the standard transvenous lead extraction system by counter-traction (P < 0.01). Among these leads, we successfully removed nine of 10 ICD leads (90%) in the RF group and only four of seven ICD leads (57%) in the standard group. We also observed a significant reduction in the time taken for the successful removal of pacemaker and ICD leads using the RF system (9.6 +/- 6.2 min versus 21 +/- 9 min, P < 0.01). Partial success was achieved in six patients with the RF system and in 11 with standard sheaths. In those cases where we failed to remove the lead from the body we sent all but one patient to cardiac surgery. Serious complications were associated with the standard system in two patients, both of whom developed septic pulmonary embolization. Serious bleeding occurred in three patients, one with standard and two with the EDS lead extraction system. CONCLUSION: The EDS extraction system is significantly more effective and quicker. However, the standard counter-traction method is still an effective alternative when used in a highly experienced centre.