Independent multicenter study of Riata and Riata ST implantable cardioverter-defibrillator leads

Abdelhadi, Raed; Saba, Samir; Ellis, Christopher R.; Mason, Pamela; Kramer, Daniel B.; Friedman, Paul A.; Gura, Melanie T.; DiMarco, John P.; Mugglin, Andrew S.; Reynolds, Matthew R.; Bazaz, Raveen; Retel, Linda Kallinen; Hayes, David L.; Hauser, Robert G.

doi:10.1016/j.hrthm.2012.10.045

Cited by 68 publications

(51 citation statements)

References 14 publications

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“…This may allow early detection of device and lead malfunction. [7][8][9][10][11] Thus, the routine use of RPM enhances device safety and resource use and may improve clinical outcomes.…”

mentioning

confidence: 99%

Use of Remote Monitoring of Newly Implanted Cardioverter-Defibrillators

et al. 2013

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Background-Current guidelines recommend using remote patient monitoring (RPM) for implantable cardioverterdefibrillators, but the patterns of adoption of this technology have not been described. Successful use of RPM depends on (1) the enrollment of the patient into an RPM system and (2) subsequent activation of RPM by the enrolled patient. We examined RPM enrollment and activation rates and the patient, physician, and institutional determinants of RPM use. Methods and Results-Information about the use of RPM-capable devices was obtained from the Boston Scientific Corporation ALTITUDE program and linked to the National Cardiovascular Data Registry ICD Registry. Patients were first categorized as RPM-enrolled and RPM-not enrolled, and the RPM-enrolled patients were further categorized into RPM-active and RPM-inactive groups based on whether they transmitted RPM data. Variables associated with RPM enrollment and activation were identified with the use of multivariable logistic regression. Among 39 158 patients with newly implanted RPM-capable devices, 62% (n=24 113) were RPM-enrolled. Of those enrolled, 76% (n=18 289, or 47% of the entire cohort) activated their device. RPM enrollment was highly variable among institutions. The hospital-specific median odds ratio for RPM enrollment was 3.43, signifying that physician or institutional factors are associated with RPM enrollment. In contrast, the hospital-specific median odds ratio for RPM activation was 1.69. Age, race, health insurance, geographic location, and health-related factors were similarly associated with both RPM enrollment and activation. Conclusions-RPM technology is used in less than half of eligible patients. Lack of enrollment into RPM systems is the major cause of underutilization, and this primarily relates to the local practice environment.

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“…This may allow early detection of device and lead malfunction. [7][8][9][10][11] Thus, the routine use of RPM enhances device safety and resource use and may improve clinical outcomes.…”

mentioning

confidence: 99%

Use of Remote Monitoring of Newly Implanted Cardioverter-Defibrillators

et al. 2013

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“…Some engineering considerations predict that inside-out abrasions should occur less frequently in 7F leads than 8F leads because the conductor lumens are narrower and closer to the central axis. 17 This is supported by a prospective study in which exteriorized cables were more common in 8F leads than 7F leads (17.9% versus 9.4% for leads implanted <6 years). However, variation in reported rates may be caused by lack of standardized imaging and uniform definitions.…”

Section: Riata-family Insulation Breachesmentioning

confidence: 79%

“…17,19 Abnormally low impedance may also be caused by reversed connection of proximal and distal shock coils to the header on IS-1 leads.…”

Section: High-voltage Insulation Breachesmentioning

confidence: 99%

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Implantable Cardioverter-Defibrillator Leads

Swerdlow

Ellenbogen

2013

Circulation

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“…Data from a large cross sectional study from Canada surveying 4,358 leads revealed an overall 4.6% rate of electrical abnormalities, most common being elevated pacing thresholds and pacing lead impedance [16]. A multicenter study by Abdelhadi et al [17] also found higher electrical failure in 27% of the externalized lead cohort, suggesting leads with externalization are more likely to have electrical malfunction. These findings likely suggest that leads with externalization will likely manifest some form of electrical malfunction over time and as such require very close monitoring of electrical parameters and should prompt appropriate action, if significant electrical defects are detected.…”

Section: Discussionmentioning

confidence: 99%