A novel bio envelope and suture orientation for stabilization of the subcutaneous implantable cardioverter-defibrillator generator to the chest wall.
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ABSTRACT:
SUBMITTER: Xiang K
PROVIDER: S-EPMC6700997 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description: Not available
| S-EPMC7300333 | biostudies-literature
Project description:BackgroundAdult congenital heart disease (ACHD) patients can benefit from a subcutaneous implantable cardioverter-defibrillator (S-ICD).ObjectiveThe purpose of this study was to assess left- and right-sided S-ICD eligibility in ACHD patients, use machine learning to predict S-ICD eligibility in ACHD patients, and transform 12-lead electrocardiogram (ECG) to S-ICD 3-lead ECG, and vice versa.MethodsACHD outpatients (n = 101; age 42 ± 14 years; 52% female; 85% white; left ventricular ejection fraction [LVEF] 56% ± 9%) were enrolled in a prospective study. Supine and standing 12-lead ECG were recorded simultaneously with a right- and left-sided S-ICD 3-lead ECG. Peak-to-peak QRS and T amplitudes; RR, PR, QT, QTc, and QRS intervals; Tmax, and R/Tmax (31 predictor variables) were tested. Model selection, training, and testing were performed using supine ECG datasets. Validation was performed using standing ECG datasets and an out-of-sample non-ACHD population (n = 68; age 54 ± 16 years; 54% female; 94% white; LVEF 61% ± 8%).ResultsForty percent of participants were ineligible for S-ICD. Tetralogy of Fallot patients passed right-sided screening (57%) more often than left-sided screening (21%; McNemar χ2P = .025). Female participants had greater odds of eligibility (adjusted odds ratio [OR] 5.9; 95% confidence interval [CI] 1.6-21.7; P = .008). Validation of the ridge models was satisfactory for standing left-sided (receiver operating characteristic area under the curve [ROC AUC] 0.687; 95% CI 0.582-0.791) and right-sided (ROC AUC 0.655; 95% CI 0.549-0.762) S-ICD eligibility prediction. Validation of transformation matrices showed satisfactory agreement (<0.1 mV difference).ConclusionNearly half of the contemporary ACHD population is ineligible for S-ICD. The odds of S-ICD eligibility are greater for female than for male ACHD patients. Machine learning prediction of S-ICD eligibility can be used for screening of S-ICD candidates.
| S-EPMC7197388 | biostudies-literature
Project description: Not available
| S-EPMC9811013 | biostudies-literature
Project description:The subcutaneous implantable cardioverter defibrillator (S-ICD) has been developed to avert risks associated with transvenous defibrillator leads. The technology is attractive for younger patients, such as those with hypertrophic cardiomyopathy (HCM). However, there are limited data on S-ICD use in HCM.HCM patients identified at risk for sudden death were considered for S-ICD implantation. Patients were screened for potential oversensing by surface electrocardiography (ECG). At implant, defibrillation threshold (DFT) testing was performed at 65, 50, and 35 joules (J). Twenty-seven patients were considered for S-ICD implantation, and after screening, 23 (85%) remained eligible. The presence of a bundle branch block was associated with screening failure, whereas elevated body mass index (BMI) showed a trend toward association. One patient passed screening at rest, but failed with an ECG obtained after exercise. At implant, the S-ICD terminated ventricular fibrillation (VF) with a 65J shock in all 15 implanted patients and a 50J shock was successful in 12 of 15. A 35J shock terminated VF in 10 of 12 patients. DFT failure at 50 J was associated with a higher BMI. There were no appropriate shocks after a median follow-up of 17.5 (3-35) months, and 1 patient received an inappropriate shock attributable to a temporary reduction in QRS amplitude while bending forward, resulting in oversensing, despite successful screening.In a high-risk HCM cohort without a pacing indication referred for consideration of an ICD, the majority were eligible for S-ICD. The S-ICD is effective at recognizing and terminating VF at implant with a wide safety margin.
| S-EPMC4802466 | biostudies-other
Project description:Abstract Background Subcutaneous implantable cardioverter-defibrillators (S-ICDs) are increasingly used in patients without a pacing indication, and may reduce venous complications, endocarditis and extraction morbidity. Subcutaneous implantable cardioverter-defibrillator displacements may be less obvious than their transvenous counterparts. Case summary A 59-year-old man was found to have dilated cardiomyopathy associated with heavy alcohol intake following investigation for a stroke. Despite 2 years of alcohol cessation and optimal drug therapy, his ejection fraction remained severely impaired, and he received an S-ICD using the manufacturer recommended screening and implant method, and by an experienced operator. Ten months later, inappropriate shocks were delivered despite optimal programming. Device displacement was demonstrated by lateral chest radiography on the second instance of inappropriate therapy. On the first admission, a lateral film was not performed, and simple device programming was undertaken which failed to prevent the second occurrence. The patient requested an explant; as ventricular function had improved following initiation of sacubutril/valsartan, the clinical team opted to remove the device. Discussion Careful inspection of lateral chest films and review of device indication are needed to reduce the risk of inappropriate shocks. This is the first description of inappropriate device activity following lone generator displacement—lead displacement is well described.
| S-EPMC9901276 | biostudies-literature
Project description:BackgroundReports on the subcutaneous implantable cardioverter-defibrillator (S-ICD) cumulatively demonstrate a low rate of complications, but clinical experience with this technology is limited compared with transvenous devices.ObjectiveThe purpose of this study was to describe and analyze S-ICD complications reported to the Food and Drug Administration's Manufacturer and User Facility Device Experience database.MethodsWe reviewed all S-ICD events reported to the Manufacturer and User Facility Device Experience submitted over 24 months (from February 2016 through February 2018) through a prospective and standardized approach at a time when an estimated 15,000 S-ICDs were in service.ResultsAfter removing duplicate entries and nonclinical events (n = 493), 1604 events remained. A total of 542 instances of infection were reported with system removal in 414/542 (77.5%). Inappropriate shocks occurred in 550 patients, and 382 (69%) were attributed to oversensing; in response, 254 (56%), 147 (33%), and 80 (18%) patients underwent system reprogramming, removal, or revision, respectively. There were 15 deaths, and causes included defibrillation failure during follow-up (n = 2), ventricular fibrillation induced by the device (n = 4), device-device interaction resulting in undersensing (n = 1), procedure-related complications (n = 4), and uncertain etiology (n = 4). There were 137 reports of system migration, and in 57 (42%) of these, there were associated inappropriate shocks. System migration events were managed with a combination of system revision (69 [51%]), reprogramming (25 [18%]), and system removal (44 [32%]).ConclusionSeveral S-ICD complications have been reported that appear to be related to the ICD's design and function over time. A better understanding of these complications may help inform patient selection, implant technique, and postimplantation management.
| S-EPMC7519585 | biostudies-literature
Project description:BackgroundRates of cardiac-device infections have increased in recent years, but the current incidence and risk factors for infection in patients with implantable cardioverter-defibrillators (ICDs) are not well known.HypothesisThe increasing number of ICD infections is related to accumulated pocket manipulations over time.MethodsThis single-center, prospective study included patients that underwent ICD implantation from 2008 to 2015. The endpoint was time to infection. Multivariate analysis was performed to identify independent risk factors related to infection.ResultsThe study included a total of 570 patients, of whom 419 (73.5%) underwent a first implantation. Mean age was 59 ± 14 years, and 80% were male. During a median follow-up of 36 months (interquartile range, 18-61 months; 1887 patient-years), infection was identified in 26 patients (4.56%), an incidence of 14.9 × 1000 patient-years. Median time to infection was 9.7 months (interquartile range, 1.35-23.4 months), and 38.5% were late infections (beyond 12 months of follow-up). In patients with replacement implants, the incidence was 3-fold higher than in first implantations (27.7 vs 9.1 × 1000 patient-years; P = 0.002). Cox regression identified 2 independent predictors of ICD infection: cumulative number of interventions at the generator pocket (hazard ratio: 1.92, 95% confidence interval: 1.42-2.6, P < 0.001) and pocket hematoma (hazard ratio: 7.0, 95% confidence interval: 2.7-17.9, P < 0.0001).ConclusionsThe incidence of infection in ICD patients is greater than previously reported, largely due to late infections. Each new cumulative intervention at the same generator pocket nearly doubles the risk of infection.
| S-EPMC6490359 | biostudies-literature
Project description:BACKGROUND:Infection is a well-recognized complication of cardiovascular implantable electronic device (CIED) implantation, including the more recently available subcutaneous implantable cardioverter-defibrillator (S-ICD). Although the AHA/ACC/HRS guidelines include recommendations for S-ICD use, currently there are no clinical trial data that address the diagnosis and management of S-ICD infections. Therefore, an expert panel was convened to develop consensus on these topics. METHODS:A process mapping methodology was used to achieve a primary goal - the development of consensus on the diagnosis and management of S-ICD infections. Two face-to-face meetings of panel experts were conducted to recommend useful information to clinicians in individual patient management of S-ICD infections. RESULTS:Panel consensus of a stepwise approach in the diagnosis and management was developed to provide guidance in individual patient management. CONCLUSION:Achieving expert panel consensus by process mapping methodology in S-ICD infection diagnosis and management was attainable, and the results should be helpful in individual patient management.
| S-EPMC7607386 | biostudies-literature
Project description:The use of subcutaneous implantable cardioverter-defibrillators (S-ICDs) has increased over time. Device-based algorithms have been developed to reduce inappropriate shocks. New implant techniques have been developed including the two-incision technique and the placement of the generator submuscularly. More patients are being implanted without general anesthesia. This review summarizes the newest S-ICD features, surgical implantation methods, and device-related safety and efficacy findings.
| S-EPMC7252801 | biostudies-literature
Project description: Not available
| S-EPMC9485762 | biostudies-literature