High Incidence of Device-Related and Lead-Related Complications in the Dual-Chamber Implantable Cardioverter Defibrillator Compared With the Single-Chamber Version.

Takahashi, Tamana; Bhandari, Anil K.; Watanuki, Masato; Cannom, David S.; Sakurada, Harumizu; Hiraoka, Masayasu

doi:10.1253/circj.66.746

Cited by 54 publications

(38 citation statements)

References 10 publications

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“…Twenty device-related complications occurred in 19 patients. The overall complication rate was slightly higher than that reported from other dual-chamber ICD trials (13% to 16%/7.1 to 9 months 28,29 ). The number of atrial leads to be revised was close to the complication rate reported in other dual-chamber trials: 3.4% and 11% in 1.7 and 13.3 months, respectively.…”

Section: Device-related Complicationscontrasting

confidence: 63%

The 1+1 Trial

et al. 2004

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Background-The tachycardia detection interval (TDI) in implantable cardioverter/defibrillators (ICDs) is conventionally programmed according to the slowest documented ventricular tachycardia (VT), with a safety margin of 30 to 60 ms. With this margin, VTs above the TDI may occur. However, longer TDIs are associated with an increased risk of inappropriate therapy. We hypothesized that patients with slow VTs (Ͻ200 bpm) may benefit from a long TDI and a dual-chamber detection algorithm compared with a conventionally programmed single-chamber ICD. Methods and Results-Patients with VTs Ͻ200 bpm were implanted with a dual-chamber ICD that was randomly programmed to a dual-chamber algorithm and a TDI of Ն469 ms or to a single-chamber algorithm with a TDI 30 to 60 ms above the slowest documented VT cycle length and the enhancement criteria of cycle length variation and acceleration. The primary combined end point was the number of all inappropriate therapies, VTs above the TDI, and VTs with significant therapy delay (Ͼ2 minutes). After 6 months, a crossover analysis was performed. Total follow-up was 1 year. One hundred two patients were included in the study. The programmed TDI was 500Ϯ36 ms during the dual-chamber phase and 424Ϯ63 ms during the single-chamber phase. For the primary end point (inappropriate therapies, VTs above the TDI, or VTs with detection delay), a moderate superiority of the dual-chamber mode was found: Mann-Whitney estimatorϭ0.6661; 95% CI, 0.5565 to 0.7758; Pϭ0.0040. Conclusions-Dual-chamber detection with a longer TDI improves VT detection and does not increase the rate of inappropriate therapies despite a considerable increase in tachycardia burden.

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Section: Device-related Complicationscontrasting

confidence: 63%

The 1+1 Trial

et al. 2004

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“…[27][28][29][30] These observations may reflect differences in severity of underlying cardiac disease.…”

Section: Discussionmentioning

confidence: 99%

Complication Rates Associated With Pacemaker or Implantable Cardioverter-Defibrillator Generator Replacements and Upgrade Procedures

et al. 2010

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for the REPLACE Registry InvestigatorsBackground-Prospective studies defining the risk associated with pacemaker or implantable cardioverter-defibrillator replacement surgeries do not exist. These procedures are generally considered low risk despite results from recent retrospective series reporting higher rates. Methods and Results-We prospectively assessed predefined procedure-related complication rates associated with elective pacemaker or implantable cardioverter-defibrillator generator replacements over 6 months of follow-up. Two groups were studied: those without (cohort 1) and those with (cohort 2) a planned transvenous lead addition for replacement or upgrade to a device capable of additional therapies. Complications were adjudicated by an independent events committee. Seventy-two US academic and private practice centers participated. Major complications occurred in 4.0% (95% confidence interval, 2.9 to 5.4) of 1031 cohort 1 patients and 15.3% (95% confidence interval, 12.7 to 18.1) of 713 cohort 2 patients. In both cohorts, major complications were higher with implantable cardioverter-defibrillator compared with pacemaker generator replacements. Complications were highest in patients who had an upgrade to or a revised cardiac resynchronization therapy device (18.7%; 95% confidence interval, 15.1 to 22.6). No periprocedural deaths occurred in either cohort, although 8 later procedure-related deaths occurred in cohort 2. The 6-month infection rates were 1.4% (95% confidence interval, 0.7 to 2.3) and 1.1% (95% confidence interval, 0.5 to 2.2) for cohorts 1 and 2, respectively. Conclusions-Pacemaker and implantable cardioverter-defibrillator generator replacements are associated with a notable complication risk, particularly those with lead additions. These data support careful decision making before device replacement, when managing device advisories, and when considering upgrades to more complex systems. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00395447.

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“…Additional causes for chronic mechanical stress on the lead could be higher activity as in younger patients, restricted anatomic circumstances as in female patients, or multiple leads in the vein. 25 Insulation damage caused by mechanical stress is time dependent. Therefore, lead failure becomes more common a problem in younger ICD patients and patients with better preserved left ventricular function who have a longer life expectancy.…”

Section: Mechanisms Of Lead Failurementioning

confidence: 99%

Annual Rate of Transvenous Defibrillation Lead Defects in Implantable Cardioverter-Defibrillators Over a Period of >10 Years

et al. 2007

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Background— The number of patients with longer follow-up after implantation of an implantable cardioverter-defibrillator is increasing continuously. Defibrillation lead failure is a typical long-term complication. Therefore, the long-term reliability of implantable cardioverter-defibrillator leads has become an increasing concern. The aim of the present study was to assess the annual rate of transvenous defibrillation lead defects related to follow-up time after lead implantation. Methods and Results— A total of 990 consecutive patients who underwent first implantation of an implantable cardioverter-defibrillator between 1992 and May 2005 were analyzed. Median follow-up time was 934 days (interquartile range, 368 to 1870). Overall, 148 defibrillation leads (15%) failed during the follow-up. The estimated lead survival rates at 5 and 8 years after implantation were 85% and 60%, respectively. The annual failure rate increased progressively with time after implantation and reached 20% in 10-year-old leads ( P <0.001). Lead defects affected newer as well as older models. Patients with lead defects were 3 years younger at implantation and more often female. Multiple lead implantation was associated with a trend to a higher rate of defibrillation lead defects ( P =0.06). The major lead complications were insulation defects (56%), lead fractures (12%), loss of ventricular capture (11%), abnormal lead impedance (10%), and sensing failure (10%). Conclusions— An increasing annual lead failure rate is noted primarily during long-term follow-up and reached 20% in 10-year-old leads. Patients with lead defects are younger and more often female.

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High Incidence of Device-Related and Lead-Related Complications in the Dual-Chamber Implantable Cardioverter Defibrillator Compared With the Single-Chamber Version.

Cited by 54 publications

References 10 publications

The 1+1 Trial

The 1+1 Trial

Complication Rates Associated With Pacemaker or Implantable Cardioverter-Defibrillator Generator Replacements and Upgrade Procedures

Annual Rate of Transvenous Defibrillation Lead Defects in Implantable Cardioverter-Defibrillators Over a Period of >10 Years

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