Delayed cardiac perforation of the Durata implantable cardioverter-defibrillator lead more than 1 year after implantation.
Ontology highlight
ABSTRACT:
SUBMITTER: Sharma SK
PROVIDER: S-EPMC5419938 | biostudies-literature | 2016 Sep
REPOSITORIES: biostudies-literature
Publications
Delayed cardiac perforation of the Durata implantable cardioverter-defibrillator lead more than 1 year after implantation.
Sharma Sandeep K SK Weinsaft Jonathan W JW Ip James E JE Cheung Jim W JW
HeartRhythm case reports 20160616 5
Similar Datasets
Project description:BackgroundPerforation of a device lead through the myocardium is a recognized complication of cardiac device implantation. The associated morbidity and mortality are significant, even though it is a relatively rare complication. Therefore, it is vital for acute clinicians to be aware of the diagnosis and subsequent management of myocardial perforation.Case summaryWe present the case of a 48-year-old woman who presented to the emergency department 1 month following implantable cardioverter-defibrillator implantation with chest and shoulder pain. Initial assessment revealed bilateral pleural effusions and anaemia. Computerized tomography of her chest and abdomen demonstrated a pericardial effusion, but it was transthoracic echocardiography that confirmed the diagnosis of right ventricular perforation. Urgent system revision was undertaken.DiscussionThis case highlights the importance of clinical suspicion and the use of diagnostic echocardiography as an important diagnostic tool in symptomatic patient's post-cardiac device implantation.
| S-EPMC6764542 | biostudies-literature
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: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:Background Outcomes data in patients with cardiac amyloidosis after implantable cardioverter-defibrillator (ICD) implantation are limited. We compared outcomes of patients with ICDs implanted for cardiac amyloidosis versus nonischemic cardiomyopathies (NICMs) and evaluated factors associated with mortality among patients with cardiac amyloidosis. Methods and Results Using National Cardiovascular Data Registry's ICD Registry data between April 1, 2010 and December 31, 2015, we created a 1:5 propensity-matched cohort of patients implanted with ICDs with cardiac amyloidosis and NICM. We compared mortality between those with cardiac amyloidosis and matched patients with NICM using Kaplan-Meier survival curves and Cox proportional hazards models. We also evaluated risk factors associated with 1-year mortality in patients with cardiac amyloidosis using multivariable Cox proportional hazards regression models. Among 472 patients with cardiac amyloidosis and 2360 patients with propensity-matched NICMs, 1-year mortality was significantly higher in patients with cardiac amyloidosis compared with patients with NICMs (26.9% versus 11.3%, P<0.001). After adjustment for covariates, cardiac amyloidosis was associated with a significantly higher risk of all-cause mortality (hazard ratio [HR], 1.80; 95% CI, 1.56-2.08). In a multivariable analysis of patients with cardiac amyloidosis, several factors were significantly associated with mortality: syncope (HR, 1.78; 95% CI, 1.22-2.59), ventricular tachycardia (HR, 1.65; 95% CI, 1.15-2.38), cerebrovascular disease (HR, 2.03; 95% CI, 1.28-3.23), diabetes mellitus (HR, 1.55; 95% CI, 1.05-2.27), creatinine = 1.6 to 2.5 g/dL (HR, 1.99; 95% CI, 1.32-3.02), and creatinine >2.5 (HR, 4.34; 95% CI, 2.72-6.93). Conclusions Mortality after ICD implantation is significantly higher in patients with cardiac amyloidosis than in patients with propensity-matched NICMs. Factors associated with death among patients with cardiac amyloidosis include prior syncope, ventricular tachycardia, cerebrovascular disease, diabetes mellitus, and impaired renal function.
| S-EPMC7726970 | biostudies-literature
Project description:AimsLeft ventricular ejection fraction (LVEF) is suboptimal as a sole marker for predicting sudden cardiac death (SCD). Machine learning (ML) provides new opportunities for personalized predictions using complex, multimodal data. This study aimed to determine if risk stratification for implantable cardioverter-defibrillator (ICD) implantation can be improved by ML models that combine clinical variables with 12-lead electrocardiograms (ECG) time-series features.Methods and resultsA multicentre study of 1010 patients (64.9 ± 10.8 years, 26.8% female) with ischaemic, dilated, or non-ischaemic cardiomyopathy, and LVEF ≤ 35% implanted with an ICD between 2007 and 2021 for primary prevention of SCD in two academic hospitals was performed. For each patient, a raw 12-lead, 10-s ECG was obtained within 90 days before ICD implantation, and clinical details were collected. Supervised ML models were trained and validated on a development cohort (n = 550) from Hospital A to predict ICD non-arrhythmic mortality at three-year follow-up (i.e. mortality without prior appropriate ICD-therapy). Model performance was evaluated on an external patient cohort from Hospital B (n = 460). At three-year follow-up, 16.0% of patients had died, with 72.8% meeting criteria for non-arrhythmic mortality. Extreme gradient boosting models identified patients with non-arrhythmic mortality with an area under the receiver operating characteristic curve (AUROC) of 0.90 [95% confidence intervals (CI) 0.80-1.00] during internal validation. In the external cohort, the AUROC was 0.79 (95% CI 0.75-0.84).ConclusionsML models combining ECG time-series features and clinical variables were able to predict non-arrhythmic mortality within three years after device implantation in a primary prevention population, with robust performance in an independent cohort.
| S-EPMC10516624 | biostudies-literature
Project description: Not available
| S-EPMC9735390 | biostudies-literature
Project description:BackgroundImplantable cardioverter-defibrillators are used to prevent sudden cardiac death in patients with cardiac sarcoidosis. The most recent recommendations for implantable cardioverter-defibrillator implantation in these patients are in the 2017 American Heart Association/American College of Cardiology/Heart Rhythm Society Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death. These recommendations, based on observational studies or expert opinion, have not been assessed. We aimed to assess them.MethodsWe performed a large retrospective cohort study of patients with biopsy-proven sarcoidosis and known or suspected cardiac sarcoidosis that underwent cardiovascular magnetic resonance imaging. Patients were followed for a composite end point of significant ventricular arrhythmia or sudden cardiac death. The discriminatory performance of the Guideline recommendations was tested using time-dependent receiver operating characteristic analyses. The optimal cutoff for the extent of late gadolinium enhancement predictive of the composite end point was determined using the Youden index.ResultsIn 290 patients, the class I and IIa recommendations identified all patients who experienced the composite end point during a median follow-up of 3.0 years. Patients meeting class I recommendations had a significantly higher incidence of the composite end point than those meeting class IIa recommendations. Left ventricular ejection fraction (LVEF) >35% with >5.7% late gadolinium enhancement on cardiovascular magnetic resonance imaging was as sensitive as and significantly more specific than LVEF >35% with any late gadolinium enhancement. Patients meeting 2 class IIa recommendations, LVEF >35% with the need for a permanent pacemaker and LVEF >35% with late gadolinium enhancement >5.7%, had high annualized event rates. Excluding 2 class IIa recommendations, LVEF >35% with syncope and LVEF >35% with inducible ventricular arrhythmia, resulted in improved discrimination for the composite end point.ConclusionsWe assessed the Guideline recommendations for implantable cardioverter-defibrillator implantation in patients with known or suspected cardiac sarcoidosis and identified topics for future research.
| S-EPMC6709696 | biostudies-literature
Project description:BackgroundImplantable cardioverter defibrillators (ICDs) are an adjunct to guideline-directed medical therapy for heart failure with reduced ejection fraction. The uptake of sacubitril/valsartan in this population is not well described. We report the uptake and factors associated with sacubitril/valsartan use in patients with left ventricular dysfunction undergoing ICD implantation.MethodsA retrospective chart review was performed on all patients with left ventricular dysfunction who underwent de novo primary prevention ICD implantation between October 2015 and December 2021 (n = 422) at Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada. Pre-procedure sacubitril/valsartan use was determined. Logistic regression analysis was performed to examine factors associated with sacubitril/valsartan use. A Bayesian estimator of abrupt change was employed to determine a time period in which a change in the rate of sacubitril/valsartan use occurred.ResultsLoop diuretic use (odds ratio [OR] = 2.20) and higher severity of New York Heart Association class symptoms (OR = 1.62) were associated with sacubitril/valsartan use. Sacubitril/valsartan use increased during the study period, to 59% in December 2021. This increase was larger among those aged ≥ 65 years (OR = 1.09). A change in the rate of sacubitril/valsartan use occurred 3 years after drug approval, 1 year after provincial drug coverage became available, and 6 months after being strongly recommended in clinical guidelines.ConclusionsIn a contemporary cohort of ICD patients, sacubitril/valsartan use increased between 2015 and 2021, notably in those aged ≥ 65 years and after government drug coverage became available. Understanding barriers to sacubitril/valsartan use in ICD patients is recommended to improve clinical outcomes and survival in this population.
| S-EPMC9869356 | biostudies-literature
Project description:AimsDual-coil leads were traditionally considered standard of care due to lower defibrillation thresholds (DFT). Higher complication rates during extraction with parallel progression in implantable cardioverter defibrillator (ICD) technology raised questions on dual coil necessity. Prior substudies found no significant outcome difference between dual and single coils, although using higher rates of DFT testing then currently practiced. We evaluated the temporal trends in implantation rates of single- vs. dual-coil leads and determined the associated adverse clinical outcomes, using a contemporary nation-wide ICD registry.Methods and resultsBetween July 2010 and March 2015, 6343 consecutive ICD (n = 3998) or CRT-D (n = 2345) implantation patients were prospectively enrolled in the Israeli ICD Registry. A follow-up of at least 1 year of 2285 patients was available for outcome analysis. The primary endpoint was all-cause mortality. Single-coil leads were implanted in 32% of our cohort, 36% among ICD recipients, and 26% among CRT-D recipients. Secondary prevention indication was associated with an increased rate of dual-coil implantation. A significant decline in dual-coil leads with reciprocal incline of single coils was observed, despite low rates of DFT testing (11.6%) during implantation, which also declined from 31 to 2%. In the multivariate Cox model analysis, dual- vs. single-coil lead implantation was not associated with an increased risk of mortality [hazard ratio (HR) = 1.23; P= 0.33], heart failure hospitalization (HR = 1.34; P=0.13), appropriate (HR = 1.25; P= 0.33), or inappropriate ICD therapy (HR = 2.07; P= 0.12).ConclusionReal-life rates of single-coil lead implantation are rising while adding no additional risk. These results of single-coil safety are reassuring and obtained, despite low and contemporary rates of DFT testing.
| S-EPMC5834150 | biostudies-literature