Myopotential oversensing notified by Lead Integrity Alert in a patient with implantable cardioverter defibrillator with a dedicated bipolar epicardial sensing lead.
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ABSTRACT:
SUBMITTER: Yazaki K
PROVIDER: S-EPMC5134266 | biostudies-other | 2016 Dec
REPOSITORIES: biostudies-other
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Project description:Methods17 physicians, experienced in transvenous lead removal, performed a lead extraction manoeuvre of an ICD lead on a torso phantom. They were advised to stop traction only when further traction would be considered as harmful to the patient or when--based on their experience--a change in the extraction strategy was indicated. Traction forces were recorded with a digital precision gauge.ResultsMedian traction forces on the endocardium were 10.9 N (range from 3.0 N to 24.7 N and interquartile range from 7.9 to 15.3). Forces applied to the proximal end were estimated to be 10% higher than those measured at the tip of the lead due to a friction loss.ConclusionA traction force of around 11 N is typically exerted during standard transvenous extraction of ICD leads. A traction threshold for a safe procedure derived from a pool of experienced extractionists may be helpful for the development of required adequate simulator trainings.
| S-EPMC4055293 | biostudies-literature
Project description:BackgroundSeveral defibrillator leads have been recalled due to early lead failure leading to significant patient harm. Confirming the safety of contemporary defibrillator leads is essential to optimizing treatment for patients receiving implantable cardioverter-defibrillators (ICDs). We therefore sought to assess the comparative long-term safety of the 4 most commonly implanted ICD leads within the National Cardiovascular Data Registry ICD Registry.Methods and resultsA propensity-matched survival analysis of the ICD Registry was performed evaluating 4 contemporary ICD leads in patients receiving an ICD system for the first time. All patients in the ICD Registry aged ≥18 years who underwent an implant of an ICD between April 1, 2011 and March 31, 2016 were included. Monitoring of safety began with ICD implant and continued up to 5 years. A meaningful difference in ICD failure rate was defined as twice (or more) the lead failure rate observed in the propensity-matched comparator patients. Among the 374 132 patients who received a new ICD implant, no safety alerts were triggered for the primary safety end point of lead failure for any of the high energy leads studied. Estimated rates of freedom from lead failure at 5 years ranged from 97.7% to 98.9% for the 4 high-energy leads of interest.ConclusionsThough limited by incomplete long-term outcomes ascertainment, active surveillance of the ICD Registry suggests that there were no meaningful differences in the rate of ICD high-energy lead survival for the 4 most commonly used high-energy ICD leads.
| S-EPMC7360169 | biostudies-literature
Project description:Expanded polytetrafluoroethylene (ePTFE) coated and medical adhesive back-filled (MABF) implantable cardioverter-defibrillator (ICD) coils have been promoted to reduce the fibrous ingrowth into coils that can complicate lead extraction.The purpose of this study was to test the hypothesis that ePTFE or MABF coatings are associated with greater ease of extraction.Consecutive isolated ICD lead extraction cases were identified from a prospectively collected clinical database. Primary endpoints included total procedure and fluoroscopy times, radiation dose, and fibrosis sites. Data were analyzed using univariate and multivariate analyses in total and propensity-matched groups, adjusting for lead age and other factors.Among 329 patients (80% male; age 63.7 +/- 5.4 years), 284 (86.3%) had standard coil ICD and 45 (13.7%) had treated coil ICD leads extracted, of which 17 (5.2%) were ePTFE coated and 28 (8.5%) were MABF ICD leads. The ePTFE and MABF leads were associated with lower procedure and fluoroscopy times, radiation dose, and fibrosis sites, even after adjustment for lead age, which was significantly shorter in the treated coil leads. To further adjust for the difference in lead age, a propensity-matched group was analyzed. Procedure time, fluoroscopy time, radiation dose, and brachiocephalic fibrosis remained significantly lower in the treated coil lead group.The ePTFE- and MABF-treated coils appear to provide some incremental benefit in ease of extraction over conventional, nontreated coil ICD leads. Although many current ICD leads do not have fibrosis ingrowth-limiting strategies, our study may rationalize the consideration of adding such technologies to future leads.
| S-EPMC2904834 | biostudies-literature
Project description:BackgroundDespite the widespread use of implantable cardioverter-defibrillators (ICDs) in clinical practice, concerns exist regarding ICD lead durability. The performance of specific lead designs and factors determining this in large populations need clarification.Methods and resultsThe Medline, Embase, and Cochrane Collaboration databases were searched for studies including ?2 of the most commonly implanted leads. The Mantel-Haenszel random-effects model was used. Seventeen studies were selected, including a total of 49 871 patients-5538 implanted with Durata (St. Jude Medical Inc), 10 605 with Endotak Reliance (Boston Scientific), 16 119 with Sprint Quattro (Medtronic Corp), 11 709 with Sprint Fidelis (Medtronic Corp), and 5900 with Riata (St. Jude Medical Inc)-with follow-up of 136 509 lead-years. Although the Durata lead presented a numerically higher rate, no statistically significant differences in the mean incidence of lead failure (0.29%-0.45% per year) were observed in comparison of the 3 nonrecalled leads. A higher event rate was documented with the Riata (1.0% per-year increase) and Sprint Fidelis (>2.0% per-year increase) leads compared with nonrecalled leads. An indication of increased incidence of Durata lead failure versus Sprint Quattro and Endotak Reliance leads was observed in 1 of 3 included studies, allowing for comparison of purely electrical lead failure, but this requires further evaluation.ConclusionsEndotak Reliance (8F), Sprint Quattro (8F), and Durata (7F) leads displayed low annual incidence of failure; however, long-term follow-up data are still scarce. More data are needed to clarify the performance and safety of the Durata lead.
| S-EPMC4845221 | biostudies-literature
Project description:BackgroundThere are conflicting data on the impact of implantable cardioverter-defibrillator (ICD) shocks on subsequent mortality.ObjectivesThe aim of this study was to determine whether the arrhythmic substrate leading to ICD therapy or the therapy itself increases mortality.MethodsThe study cohort included 5,516 ICD recipients who were enrolled in 5 landmark ICD trials (MADIT-II, MADIT-RISK, MADIT-CRT, MADIT-RIT, RAID). The authors evaluated the association of device therapy with subsequent mortality in 4 separate time-dependent models: model I, type of ICD therapy; model II, type of arrhythmia for which ICD therapy was delivered; model III, combined assessment of all arrhythmia and therapy types during follow-up; and model IV, incremental risk associated with repeated ICD shocks.ResultsWhen analyzed by the type of ICD therapy (model I), a first appropriate ICD shock was associated with increased risk of subsequent mortality with or without concomitant occurrence of inappropriate shock during follow-up (hazard ratio [HR]: 2.78 and 2.31; p < 0.001 and p = 0.12), whereas inappropriate shock alone was not associated with mortality risk (HR: 1.23; p = 0.42). Similarly, ICD therapy for ventricular tachycardia (VT) ≥200 beats/min or ventricular fibrillation (VF) (model II) was associated with increased risk of death with or without concomitant therapy for VT <200 beats/min (HRs: 2.25 and 2.62; both p < 0.001), whereas appropriate therapy for VT <200 beats/min or inappropriate therapy (regardless of etiology) did not reach statistical significance (all p > 0.10). Combined assessment of all therapy and arrhythmia types during follow-up (model III) showed that appropriate ICD shocks for VF, shocks for fast VT (≥200 beats/min) without prior antitachycardia pacing (ATP), as well as shocks for fast VT delivered after failed ATP, were associated with the highest risk of subsequent death (HR: all >2.8; p < 0.001). Finally, 2 or more ICD appropriate shocks were not associated with incremental risk to the first appropriate ICD shock (model IV).ConclusionThe combined data from 5 landmark ICD trials suggest that the underlying arrhythmic substrate rather than the ICD therapy is the more important determinant of mortality in ICD recipients.
| S-EPMC8142936 | biostudies-literature
Project description:Background One third of primary prevention implantable cardioverter-defibrillator patients receive appropriate therapy, but all remain at risk of defibrillator complications. Information on these complications in contemporary cohorts is limited. This study assessed complications and their risk factors after defibrillator implantation in a Dutch nationwide prospective registry cohort and forecasts the potential reduction in complications under distinct scenarios of updated indication criteria. Methods and Results Complications in a prospective multicenter registry cohort of 1442 primary implantable cardioverter-defibrillator implant patients were classified as major or minor. The potential for reducing complications was derived from a newly developed prediction model of appropriate therapy to identify patients with a low probability of benefitting from the implantable cardioverter-defibrillator. During a follow-up of 2.2 years (interquartile range, 2.0-2.6 years), 228 complications occurred in 195 patients (13.6%), with 113 patients (7.8%) experiencing at least one major complication. Most common ones were lead related (n=93) and infection (n=18). Minor complications occurred in 6.8% of patients, with lead-related (n=47) and pocket-related (n=40) complications as the most prevailing ones. A surgical reintervention or additional hospitalization was required in 53% or 61% of complications, respectively. Complications were strongly associated with device type. Application of stricter implant indication results in a comparable proportional reduction of (major) complications. Conclusions One in 13 patients experiences at least one major implantable cardioverter-defibrillator-related complication, and many patients undergo a surgical reintervention. Complications are related to defibrillator implantations, and these should be discussed with the patient. Stricter implant indication criteria and careful selection of device type implanted may have significant clinical and financial benefits.
| S-EPMC8174382 | biostudies-literature
Project description:Background Implantable cardioverter-defibrillators (ICDs) are indicated in patients with severe left ventricular dysfunction, but many eligible patients do not receive them, especially women and Black patients. Our group had previously demonstrated that a best practice alert (BPA) improves overall rates of electrophysiology referrals and ICD implantations. This study examined the impact of a BPA by sex and race. Methods and Results This is a cluster randomized trial of cardiology (n=106) and primary care (n=89) providers who were randomized to receive (BPA, n=93) or not receive (No BPA, n=102) the alert and managed 1856 patients meeting primary prevention criteria for ICD implantation (965 BPA and 891 No BPA). After a median follow up of 34 months, 630 (34%) patients were referred to electrophysiology, and 522 (28%) patients received an ICD. Compared with the No BPA arm, patients in the BPA arm saw a modest differential increase in the rate of electrophysiology referrals at 18 months in men (+4%) compared with women (+7%) but a profound increase in Black patients (+16%) compared with White patients (+2%), thus closing the sex and race gaps. Similar trends were noted for rates of ICD implantation. Conclusions Use of a BPA improves rates of electrophysiology referrals and ICD implantations in all comers with severe cardiomyopathy and no prior ventricular arrhythmias but has a more pronounced impact in women and Black patients. The use of a BPA at the point of care is an effective tool in the fight against sex and race inequities in health care.
| S-EPMC9075484 | biostudies-literature
Project description:BackgroundPace-sense conductors comprise a pacing coil to the tip electrode and cable to the ring-electrode. Implantable cardioverter-defibrillator (ICD) lead-monitoring diagnostics include pacing impedance (direct current resistance [DCR]) and measures of oversensing. How they change as fractures progress is unknown.ObjectivesTo characterize the relationship between oversensing, impedance, and structural changes in ICD leads developing pace-sense conductor fractures.MethodsWe performed bending tests on 39 leads connected to ICD generators in an electrolyte bath with simulated electrograms. DCR was recorded every 3 minutes; electrograms were telemetered continuously. Twenty-two leads were tested to develop partial or complete fracture criteria confirmed by imaging, using DCR or DCR variability measured by standard deviation (σDCR). Results are reported for 17 other test leads.ResultsInitial oversensing occurred with partial pacing coil fracture vs complete ring cable fracture and correlated with bending-induced DCR peaks. These peaks were too small to be detected by clinical impedance measurements and were characterized by small increases in σDCR (≥0.5 Ω). Impedance threshold alerts occurred at complete pacing coil fracture but only later for ring cable fractures. The oversensing alert triggered before device-detected ventricular fibrillation more frequently than impedance alerts (94% vs 17%; P = .00002).ConclusionsIn conductor fracture, early oversensing corresponds to partial pacing coil fracture or complete ring cable fracture and correlates with transient bending-induced impedance increases, which are detected by impedance variability but too small to trigger clinical impedance alerts. This explains why clinical oversensing alerts provide more warning for device-detected ventricular fibrillation than impedance alerts and suggests how to improve impedance diagnostics based on short-term variability.
| S-EPMC9795312 | biostudies-literature
Project description: Not available
| S-EPMC7300333 | biostudies-literature
Project description:Abstract Background Implantable cardioverter-defibrillator (ICD) implantation is a key therapeutic option in arrhythmogenic right ventricular cardiomyopathy (ARVC) to prevent sudden cardiac death due to ventricular tachycardia (VT) and fibrillation (VF). However, sub-optimized R-wave sensing due to myocardium loss interferes with VT/VF identification and appropriate therapy. We tried to implant a 3830 lead to the left ventricular septum (LVS) to facilitate ICD sensing in an ARVC patient. Case summary A 68-year-old woman diagnosed with ARVC was scheduled to undergo ICD implantation. Initially, no sites with suitable R-wave amplitudes were found in the right ventricle (RV) to deploy the defibrillation lead (<3.0 mV). It was likely due to severe RV involvement, but the LVS myocardium was more preserved based on cardiac magnetic resonance imaging. Therefore, we implanted a 3830 lead into the deep area of the septum to facilitate R-wave sensing. During the procedure from the right to left septum, the R-wave amplitude significantly increased (2.6 to 4.3–7.1 mV). Left ventricular septum pacing was finally achieved with favourable R-wave sensing (9.9 mV 24 h post-operation). The 3830 lead was plugged into the IS-1 port, while the defibrillation lead was plugged into the DF-1 port. After a 4-month follow-up, the R-wave amplitude of the 3830 lead was 11.1 mV. Discussion When the R-wave sensing is not acceptable for ICD implantation in ARVC patients, it is critical to assess myocardial conditions comprehensively. If the septal myocardium is preserved, implanting a 3830 lead to the deep or LVS is feasible to improve R-wave sensing.
| S-EPMC9843673 | biostudies-literature