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 | 2019 Aug
REPOSITORIES: biostudies-literature
Publications
A novel bio envelope and suture orientation for stabilization of the subcutaneous implantable cardioverter-defibrillator generator to the chest wall.
Xiang Kun K Levine Joshua D JD Elayi S Claude SC Su Jialin J Hsu Steve S Kim Robert R Catanzaro John N JN
HeartRhythm case reports 20190604 8
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Project description:The difference between subcutaneous implantable cardioverter defibrillators (S-ICDs) and transvenous ICDs (TV-ICDs) concerns a whole extra thoracic implantation, including a defibrillator coil and pulse generator, without endovascular components. The improved safety profile has allowed the S-ICD to be rapidly taken up, especially among younger patients. Reports of its role in different cardiac diseases at high risk of SCD such as hypertrophic and arrhythmic cardiomyopathies, as well as channelopathies, is increasing. S-ICDs show comparable efficacy, reliability, and safety outcomes compared to TV-ICD. However, some technical issues (i.e., the inability to perform anti-bradycardia pacing) strongly limit the employment of S-ICDs. Therefore, it still remains only an alternative to the traditional ICD thus far. This review aims to provide a contemporary overview of the role of S-ICDs compared to TV-ICDs in clinical practice, including technical aspects regarding device manufacture and implantation techniques. Newer outlooks and future perspectives of S-ICDs are also brought up to date.
| S-EPMC10455445 | biostudies-literature
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:BackgroundInfection remains a major complication of cardiac implantable electronic devices and can lead to significant morbidity and mortality. Implantable devices that avoid transvenous leads, such as the subcutaneous implantable cardioverter-defibrillator (S-ICD), can reduce the risk of serious infection-related complications, such as bloodstream infection and infective endocarditis. While the 2017 AHA/ACC/HRS guidelines include recommendations for S-ICD use for patients at high risk of infection, currently, there are no clinical trial data that address best practices for the prevention of S-ICD infections. Therefore, an expert panel was convened to develop a consensus on these topics.MethodsAn expert process mapping methodology was used to achieve consensus on the appropriate steps to minimize or prevent S-ICD infections. Two face-to-face meetings of high-volume S-ICD implanters and an infectious diseases specialist, with expertise in cardiovascular implantable electronic device infections, were conducted to develop consensus on useful strategies pre-, peri-, and postimplant to reduce S-ICD infection risk.ResultsExpert panel consensus on recommended steps for patient preparation, S-ICD implantation, and postoperative management was developed to provide guidance in individual patient management.ConclusionAchieving expert panel consensus by process mapping methodology for S-ICD infection prevention was attainable, and the results should be helpful to clinicians in adopting interventions to minimize risks of S-ICD infection.
| S-EPMC9544305 | biostudies-literature
Project description: Not available
| S-EPMC9811013 | biostudies-literature
Project description:BackgroundSubcutaneous 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 summaryA 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.DiscussionCareful 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: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: Not available
| S-EPMC6630194 | biostudies-literature
Project description: Not available
| S-EPMC5419807 | 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