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: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:End-stage heart failure patients with implantable cardioverter-defibrillator (ICD) with/without cardiac resynchronization therapy (CRT-D) often require heart transplantation (HTPL) as a last-resort treatment. We aimed to assess the frequency and clinical impact of retained ICD lead materials in HTPL patients. In this retrospective single center study, we examined the clinical records and chest radiographs of patients with ICD and CRT-D who underwent HTPL between January 1992 and July 2014. Of 40 patients with ICD and CRT-D at HTPL, 19 (47.5%) patients had retained ICD lead materials within the central venous system. Retained ICD lead materials following HTPL were more frequently noted in patients with longer implantation durations until HTPL. None of the patients underwent extraction procedures after HTPL. All patients were asymptomatic and did not exhibit significant complications or death related to the retained ICD lead materials. Seven (7/40, 17.5%) patients without any retained ICD lead materials underwent magnetic resonance imaging (MRI) during the follow-up period (median, 29.5 months); none of the patients with retained lead materials were given MRI. Considering the common use of MRI in HTPL patients, further studies on the prophylactic extraction of retained ICD lead materials and safety of MRI in these patients are needed.
| S-EPMC5413001 | biostudies-literature
Project description:INTRODUCTION:Subclinical atrial fibrillation (AF), in the form of cardiac implantable device-detected atrial high rate episodes (AHREs), has been associated with increased thromboembolism. An implantable cardioverter-defibrillator (ICD) lead with a floating atrial dipole may permit a single lead (DX) ICD system to detect AHREs. We sought to assess the utility of the DX ICD system for subclinical AF detection in patients, with a prospective multicenter, cohort-controlled trial. METHODS AND RESULTS:One hundred fifty patients without prior history of AF (age 59?±?13 years; 108 [72%] male) were enrolled into the DX cohort and implanted with a Biotronik DX ICD system at eight centers. Age-, sex-, and left ventricular ejection fraction-matched single- and dual-chamber ICD cohorts were derived from a Cornell database and from the IMPACT trial, respectively. The primary endpoint were AHRE detection at 12 months. During median 12 months follow-up, AHREs were detected in 19 (13%) patients in the DX, 8 (5.3%) in the single-chamber, and 19 (13%) in the dual-chamber cohorts. The rate of AHRE detection was significantly higher in the DX cohort compared to the single-chamber cohort (P?=?.026), but not significantly different compared to the dual-chamber cohort. There were no inappropriate ICD therapies in the DX cohort. At 12 months, only 3.0% of patients in the DX cohort had sensed atrial amplitudes less than 1.0?mV. CONCLUSION:Use of a DX ICD lead allows subclinical AF detection with a single lead DX system that is superior to that of a conventional single-chamber ICD system.
| S-EPMC6852241 | biostudies-literature
Project description:Background: When an implantable-cardioverter defibrillator (ICD) lead becomes non-functional, a recommendation currently exists for either lead abandonment or removal. Lead abandonment and subcutaneous ICD (S-ICD) implantation may represent an additional option for patients who do not require pacing. The aim of this study was to investigate the outcomes of a strategy of lead abandonment and S-ICD implantation in the setting of lead malfunction. Methods: We analyzed all consecutive patients who underwent S-ICD implantation after abandonment of malfunctioning leads and compared their outcomes with those of patients who underwent extraction and subsequent reimplantation of a single-chamber transvenous ICD (T-ICD). Results: Forty-three patients underwent S-ICD implantation after abandonment of malfunctioning leads, while 62 patients underwent extraction and subsequent reimplantation of a new T-ICD. The two groups were comparable. In the extraction group, no major complications occurred during extraction, while the procedure failed and an S-ICD was implanted in 4 patients. During a median follow-up of 21 months, 3 major complications or deaths occurred in the S-ICD group and 11 in the T-ICD group (HR 1.07; 95% CI 0.29-3.94; P = 0.912). Minor complications were 4 in the S-ICD group and 5 in the T-ICD group (HR 2.13; 95% CI 0.49-9.24; P = 0.238). Conclusions: In the event of ICD lead malfunction, extraction avoids the potential long-term risks of abandoned leads. Nonetheless the strategy of lead abandonment and S-ICD implantation was feasible and safe, with no significant increase in adverse outcomes, and may represent an option in selected clinical settings. Further studies are needed to fully understand the potential risks of lead abandonment. Clinical Trial Registration: URL: ClinicalTrials.gov Identifier: NCT02275637.
| S-EPMC8356671 | biostudies-literature
Project description:INTRODUCTION:The subcutaneous implantable cardioverter-defibrillator (S-ICD) is a life-saving device. Recording of a specialized 3-lead electrocardiogram (ECG) is required for S-ICD eligibility assessment. The goals of this study were: (1) evaluate the effect of ECG filtering on S-ICD eligibility, and (2) simplify S-ICD eligibility assessment by development of an S-ICD ineligibility prediction tool, which utilizes the widely available routine 12-lead ECG. METHODS AND RESULTS:Prospective cross-sectional study participants [n?=?68; 54% male; 94% white, with wide ranges of age (18-81?y), body mass index (19-53), QRS duration (66-150 ms), and left ventricular ejection fraction (37-77%)] underwent 12-lead supine, 3-lead supine and standing ECG recording. All 3-lead ECG recordings were assessed using the standard S-ICD pre-implantation ECG morphology screening. Backward, stepwise, logistic regression was used to build a model for 12-lead prediction of S-ICD eligibility. Select electrocardiogram waves and complexes: QRS, R-, S, and T-amplitudes on all 12 leads, averaged QT interval, QRS duration, and R/T ratio in the lead with the largest T wave (R/Tmax) were included as predictors. The effect of ECG filtering on ECG morphology was evaluated. A total of 9 participants (13%) failed S-ICD screening prior to filtering. Filtering at 3-40?Hz, similar to the S-ICD default, reduced S-ICD ineligibility to 4%. A regression model that included RII, SII-aVL, TI, II, aVL, aVF, V3-V6, and R/Tmax perfectly predicted S-ICD eligibility, with an Area Under the Receiver Operating Characteristic Curve of 1.0. CONCLUSION:Routine clinical 12-lead ECG can be used to predict S-ICD eligibility. ECG filtering may improve S-ICD eligibility.
| S-EPMC6218287 | biostudies-literature