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Lead Failure (lead + failure)

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Medical Sciences	100%

Selected Abstracts

Unexpected ICD Pulse Generator Failure Due to Electronic Circuit Damage Caused by Electrical Overstress

PACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 7 2001
ROBERT G. HAUSER
Hauser, R., et al.: Unexpected ICD Pulse Generator Failure Due to Electronic Circuit Damage Caused by Electrical Overstress. Because it is a lifesaving device, the unexpected failure of an ICD can be catastrophic. We report ICD electronic circuit failure due to electrical overstress damage (EOS) to the high voltage hybrid circuit and other electronic components in a series of ICD pulse generator models. Data were obtained from the Multicenter Registry of Pacemaker and ICD Pacemaker and Lead Failures, and from the manufacturers' adverse event reports, that were in the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. Of 16 nonbattery Guidant/CPI ICD pulse generator failures reported to the registry, 6 (38%) have been confirmed by the manufacturer to be EOS related, and Guidant/CPI has reported 273 such failures to the FDA as of 12/29/00. The signs of failure included loss of telemetry and inability to deliver therapy, and some patients have experienced serious adverse events. Hybrid circuit damage may have occurred during capacitor charging or reform, and the majority appears to have happened during normal ICD function. While the incidence of this problem is unknown, a management strategy should be adopted that includes routine follow-up every 3 months and device evaluation after a shock or exposure to external defibrillation or electrosurgical devices. This study suggests that additional data are needed to determine the incidence of this problem, and that our present methods for monitoring the performance of ICDs following market release are inadequate. [source]

Two Different Therapeutic Strategies in ICD Lead Defects: Additional Combined LeadVersus Replacement of the Lead

JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 11 2007
CHRISTIAN G. WOLLMANN M.D.
Objectives: Implantation of an additional HV-P/S lead versus extraction of the defective HV-P/S lead and implantation of a new one is one possible therapeutic approach in cases of a defective high-voltage pace/sense lead (HV-P/S). No information is available on potential differences in clinical outcome in these different approaches. Methods: Between January 2000 and February 2006, 86 patients with HV-P/S lead defect received either an additional transvenous HV-P/S lead (n = 33, group 1) or the HV-P/S lead was replaced (n = 53, group 2). The duration of the initially implanted leads was significantly different in the two groups (7.4 ± 2.9; group 1 and 4.1 ± 3.4 years; group 2). The outcome of these two groups of patients was retrospectively analyzed. Results: Seventy-three patients [85%] survived until the end of follow-up of 29 ± 15 (group 1) and 33 ± 21 (group 2) months (P = ns), respectively. Thirteen patients died: six in group 1 and seven in group 2 (P = ns). Fourteen patients experienced perioperative complications (group 1: six; group 2: eight; P = ns). ICD system-related complications occurred in 22 patients (group 1: seven; group two: 15; P = ns). The event-free cumulative survival of patients with additional and replaced HV-P/S lead for postoperative events (including death) after 1, 2, and 3 years was 82%, 70%, 70%, and 86%, 81%, 66%, respectively (P = 0.93). Conclusions: Implantation of an additional HV-P/S lead or replacement of the HV-P/S lead in case of HV-P/S lead failure is statistically not different concerning mortality and morbidity. There are no predictors for further lead defects. Implantation of an additional HV-P/S lead should not be recommended in young patients or patients with greater likelihood of living many years. Predictors for death were an age over 70 years and renal insufficiency. [source]

Long-term Stability of Endocardial Left Ventricular Pacing Leads Placed via the Coronary Sinus

PACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 9 2009
GRACE LIN M.D.
Background: Left ventricular endocardial pacing leads placed via the coronary sinus (CS) are increasingly implanted to achieve cardiac resynchronization therapy (CRT); however, the long-term stability of these leads is unknown. We sought to determine the implant success and long-term stability of CS leads in our single center experience. Methods: All consecutive patients who underwent CRT via implantation of the CS lead between January 1999 and December 2005 were included. Pacing thresholds at implant and during long-term follow-up were reviewed and the rate of acute (within 24 hours of implant) and chronic (>24 hours) lead failure was determined. Results: A total of 512 patients (mean age 68 ± 12 years; 409 [80%] male) underwent CRT device implantation and were included. The CS lead implantation was successful on the initial implantation in 487 patients (95%) and subsequently successful in six patients (24%) in whom initial attempts were unsuccessful. Acute lead failure occurred in 25 patients (5.1%) and was most commonly due to persistent extra-cardiac stimulation. The rate of chronic lead failure was 4% in the first year and remained stable during long-term follow-up. The CS lead pacing thresholds remained stable with only minimal increase (1.42 ± 0.85 V/0.42 ± 0.25 ms vs 1.51 ± 1.05 V/0.47 ± 0.29 ms; P = 0.04). Conclusions: Placement of a left ventricular pacing lead via the CS is feasible and safe in the vast majority of patients. Once placed, the CS leads remain stable with excellent pacing thresholds over the longer term. [source]

Feasibility Of Temporary Biventricular Pacing In Patients With Reduced Left Ventricular Function After Coronary Artery Bypass Grafting

PACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 2007
FRANK EBERHARDT M.D.
Background and Methods: Biventricular pacing improves hemodynamics after weaning from cardiopulmonary bypass in patients with severely reduced left ventricular (LV) function undergoing coronary artery bypass grafting (CABG). We examined the feasibility of temporary biventricular pacing for 96 hours postoperatively. Unipolar epicardial wires were placed on the roof of the right atrium (RA), the right ventricular (RV) outflow tract, and the LV free lateral wall and connected to an external pacing device in 51 patients (mean LV ejection fraction 35 ± 4%). Pacing and sensing thresholds, lead survival and incidence of pacemaker dysfunction were determined. Results: Atrial and RV pacing thresholds increased significantly by the 4th postoperative day, from 1.6 ± 0.2 to 2.5 ± 0.3 V at 0.5 ms (P = 0.03) at the RA, 1.4 ± 0.3 V to 2.7 ± 0.4 mV (P = 0.01) at the RV, and 1.9 ± 0.6 V to 2.9 ± 0.7 mV (P = 0.3) at the LV, while sensing thresholds decreased from 2.0 ± 0.2 to 1.7 ± 0.2 mV (P = 0.18) at the RA, 7.2 ± 0.8 to 5.1 ± 0.7 mV (P = 0.05) at the RV, and 9.4 ± 1.3 to 5.5 ± 1.1 mV (P = 0.02) at the LV. The cumulative overall incidence of lead failure was 24% by the 4th postoperative day, and was similar at the RV and LV. We observed no ventricular proarrhythmia due to pacing or temporary pacemaker malfunction. Conclusions: Biventricular pacing after CABG using a standard external pacing system was feasible and safe. [source]

Subthreshold Test Pulses Versus Low Energy Shock Delivery to Estimate High Energy Lead Impedance in Implanted Cardioverter Defibrillator Patients

PACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 1p2 2003
DIRK VOLLMANN
VOLLMANN, D., et al.: Subthreshold Test Pulses Versus Low Energy Shock Delivery to Estimate High Energy Lead Impedance in Implanted Cardioverter Defibrillator Patients. The high energy lead impedance is valuable for detecting lead failure in ICDs, but until recently shock delivery was necessary for high energy impedance measurement. This study compared the use of subthreshold test pulses and low energy test shocks to estimate the high energy impedance. Immediately after implantation of Ventak Prizm ICDs in 29 patients, the lead impedance was measured with five subthreshold (0.4 ,J) test pulses, 5 low energy (1.1 J) shocks, and two to three high energy(16 ± 4.5 J)shocks. The mean impedances measured using high energy shocks, low energy shocks, and subthreshold pulses were42.0 ± 7.3 ,, 46.5 ± 8.1 ,, and42.4 ± 7.1 ,, respectively. The impedances measured using high and low energy shocks differed significantly(P <0.0001), while those obtained by high energy shocks and low energy pulses did not(P = 0.63). According to the Pearson correlation coefficient, the impedance measurements with subthreshold pulses and low energy shocks were both closely correlated(P < 0.0001)with impedance values determined with high energy shocks. However, while the impedance values tended to be higher when measured with low energy shocks, the concordance correlation coefficient (c) was higher for subthreshold test pulse versus high energy shock(c = 0.92)than for low versus high energy shock(c = 0.73). Furthermore, the intraindividual variability of impedance measurements was lower with subthreshold pulse measurements than with low energy shocks. Compared with low energy shocks, impedance measurement with subthreshold pulses has higher reproducibility and a higher correlation with the impedance obtained by high energy shock delivery. Safe and painless high energy impedance estimation with subthreshold pulses might, therefore, help to detect ICD lead failure during routine follow-up. (PACE 2003; 26:[Pt. II]:457,460) [source]

Long-Term Structural Failure of Coaxial Polyurethane Implantable Cardioverter Defibrillator Leads

PACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 6 2002
ROBERT G. HAUSER
HAUSER, R.G., et al.: Long-Term Structural Failure of Coaxial Polyurethane Implantable Cardioverter Defibrillator Leads. Transvene models 6936/6966, a coaxial polyurethane ICD lead, may be prone to structural failure. These models comprise 54% of ICD lead failures in the authors' Multicenter Registry database. Because ICD leads perform a vital function, the clinical features, causes, and probability of Transvene 6936/6966 lead failure were determined. The Registry and United States Food and Drug Administration databases were queried for the clinical features and structural causes of the Transvene 6936/6966 lead failure, and a five-center substudy estimated the survival probability for 521 Transvene 6936/6966 implants. The mean time to failure was 4.8 ± 2.1 years, and the estimated survival at 60 and 84 months after implant were 92% and 84%, respectively. Oversensing was the most common sign of failure (76%), and 24 patients experienced inappropriate shocks. The manufacturer's reports indicated that high voltage coil fracture and 80A polyurethane defects were the predominant causes of lead failure. Transvene models 6936 and 6966 coaxial polyurethane ICD leads are prone to failure over time. Patients who have these leads should be evaluated frequently. Additional studies are needed to identify safe management strategies. [source]

Feasibility and Initial Results of an Internet-Based Pacemaker and ICD Pulse Generator and Lead Registry

PACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 1 2001
ROBERT HAUSER
HAUSER, R., et al.: Feasibility and Initial Results of an Internet-Based Pacemaker and ICD Pulse Generator and Lead Registry. The medical community has no independent source of timely information regarding the performance of pacemaker and ICD pulse generators and leads. Accordingly, the authors established an Internet-based registry of pacemaker and ICD pulse generator and lead failures (www.pacerandicregistry.com). During the first year, they found three previously unreported device problems that were promptly communicated to the participants. Of the failures reported, 11% of ICD and 10% of pacemaker pulse generator failures were heralded by signs other than the expected elective replacement indicator (ERI). Average ICD battery longevity was 4.0 ± 0.7 years, and average dual chamber pacemaker battery longevity was 6.8 ± 2.6 years. Disrupted insulation accounted for 54% of pacemaker and 29% of ICD lead failures. Compared to pacemaker pulse generator and lead failure, ICD device failures were more likely to cause severe clinical consequences. In conclusion, an Internet-based registry is feasible and capable of providing timely data regarding the signs, causes, and clinical consequences of pacemaker and ICD failures. [source]

Implantable Cardioverter Defibrillator-Related Complications in the Pediatric Population

PACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 2009
MAULLY J. SHAH M.B.B.S.
Background: The recognition that implantable cardioverter-defibrillator (ICD) therapy in children can prolong life coupled with the development of smaller devices and transvenous lead technology has increased the number of ICDs implanted in children and young adults. Methods: ICD complications in the pediatric population are reviewed. Results: ICD complications in the pediatric population include those related to the implantation procedure, the ICD system, as well as psychosocial issues. Inappropriate ICD therapy and ICD lead failures are the most frequent complications. Conclusion: Identifying complications is the prerequisite for advances in ICD technology and effective management strategies need to be developed to avoid their recurrence. [source]

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

PACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 2008
MAREN TOMASKE M.D.
Implantable cardioverter-defibrillators (ICD) are increasingly implanted for primary or secondary prevention of sudden death in young patients with congenital heart disease, cardiomyopathies, or channelopathies. Although major advances in ICD technology and implant techniques have facilitated ICD therapy in young patients, complications such as lead failures, inappropriate shocks, system infections, and negative psychosocial impacts are of concern. The various underlying cardiovascular disease states and a lack of standardized ICD protocols for young patients often necessitate individualized implant techniques, ICD programming, and follow-up. Young ICD patients need a thorough follow-up to ensure adequate therapy, and psychosocial problems have to be addressed. [source]