Safety of transvenous lead removal in adult congenital heart disease: a national perspective.

INTRODUCTION AND OBJECTIVES: Data are scarce on outcomes of transvenous lead removal (TLR) in adult congenital heart disease (CHD). We evaluated the safety of the TLR procedure in adult CHD patients from a 10-year national database. METHODS: We used the Healthcare Cost and Utilization Project Nationwide Inpatient Sample to identify TLR procedures in adult patients with and without CHD from 2005 to 2014. Outcomes included in-hospital mortality and complications. RESULTS: Of 132 068 adult patients undergoing TLR, 1939 had simple CHD, 657 had complex CHD, and 626 had unclassified CHD. The number of TLR procedures in adult CHD slightly increased from 236 in 2005 to 445 in 2014, with fluctuations over the study period. The overall rate of any complications in the TLR procedure was 16.6% in patients with CHD vs 10.1% in patients without CHD (P <.001). In a propensity score-matched cohort, CHD was associated with a higher risk of any complication after full adjustment vs patients without CHD (adjusted odd ratio, 1.49; 95% confidence interval, 1.11-1.99; P=.007). Simple and complex CHD were associated with 1.5- and 2.1-fold increased risks of any TLR-related complication, respectively. CHD was not associated with an increased risk of in-hospital mortality (adjusted odd ratio, 0.77; 95% confidence interval, 0.42-1.39; P=.386). CONCLUSIONS: Compared with patients without CHD, adult patients with simple and complex CHD undergoing TLR are more likely to have complications but show no increase in mortality.

Recent Trends in Oral Anticoagulant Use and Post-Discharge Complications Among Atrial Fibrillation Patients with Acute Myocardial Infarction.

BACKGROUND: Atrial fibrillation (AF) is a common complication of acute myocardial infarction (AMI).The CHA2DS2VAScand CHADS2risk scoresare used to identifypatients with AF at risk for strokeand to guide oral anticoagulants (OAC) use, including patients with AMI. However, the epidemiology of AF, further stratifiedaccording to patients' risk of stroke, has not been wellcharacterized among those hospitalized for AMI. METHODS: We examined trends in the frequency of AF, rates of discharge OAC use, and post-discharge outcomes among 6,627 residents of the Worcester, Massachusetts area who survived hospitalization for AMI at 11 medical centers between 1997 and 2011. RESULTS: A total of 1,050AMI patients had AF (16%) andthe majority (91%)had a CHA2DS2VAScscore >2.AF rates were highest among patients in the highest stroke risk group.In comparison to patients without AF, patients with AMI and AF in the highest stroke risk category had higher rates of post-discharge complications, including higher 30-day re-hospitalization [27 % vs. 17 %], 30-day post-discharge death [10 % vs. 5%], and 1-year post-discharge death [46 % vs. 18 %] (p < 0.001 for all). Notably, fewerthan half of guideline-eligible AF patientsreceived an OACprescription at discharge. Usage rates for other evidence-based therapiessuch as statins and beta-blockers,lagged in comparison to AMI patients free from AF. CONCLUSIONS: Our findings highlight the need to enhance efforts towards stroke prevention among AMI survivors with AF.

Safety of Transvenous Lead Removal in Patients ≥70 Years of Age in the United States from 2005 to 2012.

Cardiac devices are increasingly an element of treatment for the elderly, leading to more frequent transvenous lead removal (TLR) procedures in this population. Data on TLR in very elderly patients, especially nonagenarians, is scarce. We used Healthcare Cost and Utilization Project Nationwide Inpatient Sample to identify a total of 36,099 patients ≥70 years who underwent TLR from 2005 to 2012, with outcomes including in-hospital mortality and complications. The in-hospital mortality rate was significantly higher in nonagenarians without device infection (0.9% in age 70 to 79 vs 0.7% in age 80 to 89 vs 2.6% in age ≥90, p = 0.012), but overall complication rates were not different in age groups regardless of infection status and co-morbidity index (all p >0.05). Among patients with device infection, octogenarians, and nonagenarians were not associated with increased risk of in-hospital mortality relative to septuagenarians after controlling for all other confounders. However, in patients without device infection, logistic regression showed significantly higher mortality in patients age ≥90 years (odd ratio 4.22, 95% confidence interval 1.66 to 10.75, p = 0.003), but not in patients age 80 to 89 years (odd ratio 1.05, 95% confidence interval 0.48 to 2.30, p = 0.907), compared with patients age 70 to 79 years. In conclusion, in nonagenarians with infection, mortality is driven more by the patient's other conditions than by age. For patients without infection, however, nonagenarians experienced higher mortality than younger patients.

Maternal and Fetal Outcomes of Admission for Delivery in Women With Congenital Heart Disease.

Background: Women with congenital heart disease (CHD) may be at increased risk for adverse events during pregnancy and delivery. Objective: To compare delivery outcomes between women with and without CHD. Design, Setting, and Participants: This retrospective study of inpatient delivery admissions in the Healthcare Cost and Utilization Project's California State Inpatient Database compared maternal and fetal outcomes between women with and without CHD by using multivariate logistic regression. Female patients with codes for delivery from the International Classification of Diseases, Ninth Revision, from January 1, 2005, through December 31, 2011, were included. The association of CHD with readmission was assessed to 7 years after delivery. Cardiovascular morbidity and mortality were hypothesized to be higher among women with CHD. Data were analyzed from April 4, 2014, through January 23, 2017. Exposures: Noncomplex and complex CHD. Main Outcomes and Measures: Maternal outcomes included in-hospital arrhythmias, eclampsia or preeclampsia, congestive heart failure (CHF), length of stay, preterm labor, anemia complicating pregnancy, placental abnormalities, infection during labor, maternal readmission at 1 year, and in-hospital mortality. Fetal outcomes included growth restriction, distress, and death. Results: Among 3 642 041 identified delivery admissions, 3189 women had noncomplex CHD (mean [SD] age, 28.6 [7.6] years) and 262 had complex CHD (mean [SD] age, 26.5 [6.8] years). Women with CHD were more likely to undergo cesarean delivery (1357 [39.3%] vs 1 164 509 women without CHD [32.0%]; P < .001). Incident CHF, atrial arrhythmias, ventricular arrhythmias, and maternal mortality were uncommon during hospitalization, with each occurring in fewer than 10 women with noncomplex or complex CHD (<0.5% each). After multivariate adjustment, noncomplex CHD (odds ratio [OR], 9.7; 95% CI, 4.7-20.0) and complex CHD (OR, 56.6; 95% CI, 17.6-182.5) were associated with greater odds of incident CHF. Similar odds were found for atrial arrhythmias in noncomplex (OR, 8.2; 95% CI, 3.0-22.7) and complex (OR, 31.8; 95% CI, 4.3-236.3) CHD, for fetal growth restriction in noncomplex (OR, 1.6; 95% CI, 1.3-2.0) and complex (OR, 3.5; 95% CI, 2.1-6.1) CHD, and for hospital readmission in both CHD groups combined (OR, 3.6; 95% CI, 3.3-4.0). Complex CHD was associated with greater adjusted odds of serious ventricular arrhythmias (OR, 31.8; 95% CI, 4.3-236.3) and maternal in-hospital mortality (OR, 79.1; 95% CI, 23.9-261.8). Conclusions and Relevance: In this study of hospital admissions for delivery in California, CHD was associated with incident CHF, atrial arrhythmias, and fetal growth restriction and complex CHD was associated with ventricular arrhythmias and maternal in-hospital mortality, although these outcomes were rare, even in women with complex CHD. These findings may guide monitoring decisions and risk assessment for pregnant women with CHD at the time of delivery.

Sudden Death in Patients With Cardiac Implantable Electronic Devices.

IMPORTANCE: Interrogations and autopsies of sudden deaths with cardiac implantable electronic devices (CIEDs) are rarely performed. Therefore, causes of sudden deaths with these devices and the incidence of device failure are unknown. OBJECTIVE: To determine causes of death in individuals with CIEDs in a prospective autopsy study of all sudden deaths over 35 months as part of the San Francisco, California, Postmortem Systematic Investigation of Sudden Cardiac Death (POST SCD) study. DESIGN, SETTING, AND PARTICIPANTS: Full autopsy, toxicology, histology, and device interrogation were performed on incident sudden cardiac deaths with pacemakers or implantable cardioverter defibrillators (ICDs). The setting was the Office of the Chief Medical Examiner, City and County of San Francisco. Participants included all sudden deaths captured through active surveillance of all deaths reported to the medical examiner and San Francisco residents with an ICD (January 1, 2011, to November 30, 2013). MAIN OUTCOMES AND MEASURES: Identification of a device concern in sudden deaths with CIEDs, including hardware failures, device algorithm issues, device programming issues, and improper device selection. For the ICD population, outcomes were the cumulative incidence of death and sudden cardiac death and the proportion of deaths with an ICD concern. RESULTS: Twenty-two of 517 sudden deaths (4.3%) had CIEDs, and autopsy revealed a noncardiac cause of death in 6. Six of 14 pacemaker sudden deaths and 7 of 8 ICD sudden deaths died of ventricular tachycardia or ventricular fibrillation. Device concerns were identified in half (4 pacemakers and 7 ICDs), including 3 hardware failures contributing directly to death (1 rapid battery depletion with a sudden drop in pacing output and 2 lead fractures), 5 ICDs with ventricular fibrillation undersensing, 1 ICD with ventricular tachycardia missed due to programming, 1 improper device selection, and a pacemaker-dependent patient with pneumonia and concern about lead fracture. Of 712 San Francisco residents with an ICD during the study period, 109 died (15.3% cumulative 35-month incidence of death), and the 7 ICD concerns represent 6.4% of all ICD deaths. CONCLUSIONS AND RELEVANCE: Systematic interrogation and autopsy of sudden deaths in one city identified concerns about CIED function that might otherwise not have been observed. Current passive surveillance efforts may underestimate device malfunction. These methods can provide unbiased data regarding causes of sudden death in individuals with CIEDs and improve surveillance for CIED problems.

Device complications in adult congenital heart disease.

BACKGROUND: Pacemakers and implantable cardioverter-defibrillators (ICDs) are increasingly implanted in adults with congenital heart disease (CHD), but little is known about implant-related complications and mortality. OBJECTIVE: The purpose of this study was to compare pacemaker and ICD implantation complication rates between adults with and those without CHD using a comprehensive, statewide database. METHODS: We used the Healthcare Cost and Utilization Project database to identify initial transvenous pacemaker and ICD implantations and implant-related complications in California hospitals from January 1, 2005, to December 31, 2011. We calculated relative risks of implant-related complications by comparing those with and those without CHD using Poisson regression with robust standard errors, adjusting for age and medical comorbidities. RESULTS: We identified 105,852 patients undergoing pacemaker implantation, 1465 with noncomplex CHD and 66 with complex CHD. CHD was not associated with increased risk of pacemaker implant-related complications: adjusted risk ratio (aRR) 0.92, 95% confidence interval (CI) 0.74-1.14, P = .45. We identified 32,948 patients undergoing ICD implantation, 815 with noncomplex CHD and 87 with complex CHD. Patients with CHD had increased risk of ICD implant-related complications: aRR 1.36, 95% CI 1.05-1.76, P = .02. Patients with complex CHD had greater increased risk of ICD implant-related complications: aRR 2.14, 95% CI 1.16-3.95, P = .02. In patients receiving devices, CHD was associated with a trend toward lower 30-day in-hospital mortality after pacemaker (P = .07) and ICD (P = .19) implantation. CONCLUSION: Among adult patients undergoing device implantation in California, CHD was associated with increased risk of ICD implant-related complications, but not pacemaker implant-related complications or higher 30-day in-hospital mortality.

Arrhythmias in Complex Congenital Heart Disease.

Late after surgical repair of complex congenital heart disease, atrial arrhythmias are a major cause of morbidity, and ventricular arrhythmias and sudden cardiac death are a major cause of mortality. The six cases in this article highlight common challenges in the management of arrhythmias in the adult congenital heart disease population.

Sudden death due to nonarrhythmic cause in a patient with L-TGA.

We report a case of sudden death in a clinically stable adult with l-transposition of the great arteries (l-TGA). Sudden death has been reported to be the leading cause of death in l-TGA and is often attributed to arrhythmias in the absence of another identifiable cause. However, the contribution of nonarrhythmic causes to the burden of sudden death in this population is unknown. Comprehensive postmortem investigation, including autopsy and pacemaker interrogation, demonstrated that the cause of death was massive pulmonary hemorrhage due to stenosis of the patient's mechanical tricuspid (systemic AV) valve. This report highlights the important contribution of nonarrhythmic causes of sudden death in this population and the value of autopsy and device interrogation in determining true cause of death.

COMET-PE: an incident fluence response expansion transport method for radiotherapy calculations.

Accurate dose calculation is a central component of radiotherapy treatment planning. A new method of dose calculation has been developed based on transport theory and validated by comparison to Monte Carlo methods. The coarse mesh transport method has been extended to allow coupled photon-electron transport in 3D. The method combines stochastic pre-computation with a deterministic solver to achieve high accuracy and precision. To enhance the method for radiotherapy calculations, a new angular basis was derived, and an analytical source treatment was developed. Validation was performed by comparison to DOSXYZnrc using a heterogeneous interface phantom composed of water, aluminum, and lung. Calculations of both kinetic energy released per unit mass and dose were compared. Good agreement was found with a maximum error and root mean square relative error of less than 1.5% for all cases. The results show that the new method achieves an accuracy comparable to Monte Carlo.

Pulmonary vein isolation with complex fractionated atrial electrogram ablation for paroxysmal and nonparoxysmal atrial fibrillation: A meta-analysis.

BACKGROUND: Pulmonary vein isolation (PVI) is recognized as a potentially curative treatment for atrial fibrillation (AF). Ablation of complex fractionated atrial electrograms (CFAEs) in addition to PVI has been advocated as a means to improve procedural outcomes, but the benefit remains unclear. OBJECTIVE: This study sought t synthesize the available data testing the incremental benefit of adding CFAE ablation to PVI. METHODS: We performed a meta-analysis of controlled studies comparing the effect of PVI with CFAE ablation vs. PVI alone in patients with paroxysmal and nonparoxysmal AF. RESULTS: Of the 481 reports identified, 8 studies met our inclusion criteria. There was a statistically significant increase in freedom from atrial tachyarrhythmia (AT) with the addition of CFAE ablation (relative risk [RR] 1.15, P = .03). In the 5 reports of nonparoxysmal AF (3 randomized controlled trials, 1 controlled clinical trial, and 1 trial using matched historical controls), addition of CFAE ablation resulted in a statistically significant increase in freedom from AT (n = 112 of 181 [62%] for PVI+CFAE vs. n = 84 of 179 [47%] for PVI alone; RR 1.32, P = .02). In trials of paroxysmal AF (3 randomized controlled trials and 1 trial using matched historical controls), addition of CFAE ablation did not result in a statistically significant increase in freedom from AT (n = 131 of 166 [79%] for PVI+CFAE vs. n = 122 of 164 [74%] for PVI alone; RR 1.04, P = .52). CONCLUSION: In these studies of patients with nonparoxysmal AF, addition of CFAE ablation to PVI results in greater improvement in freedom from AF. No additional benefit of this combined approach was observed in patients with paroxysmal AF.

Inter-observer variability in the measurement of diffuse intrinsic pontine gliomas.

Diffuse intrinsic pontine glioma (DIPG) is an invasive pediatric brainstem tumor with a poor prognosis. Patients commonly enter investigational trials, many of which use radiographic response as an endpoint for assessing drug efficacy. However, DIPGs are difficult to measure on magnetic resonance imaging (MRI). In this study, we characterized the reproducibility of these commonly performed measurements. Each of four readers measured 50 MRI scans from DIPG patients and inter-observer variability was estimated with descriptive statistics. Results confirmed that there is wide variability in DIPG tumor measurements between readers for all image types. Measurements on FLAIR imaging were most consistent. For patients on clinical trials, measurement of DIPG should be performed by a single reader while comparing prior images side-by-side. Endpoints for clinical trials determining efficacy in this population should also include more objective measures, such as survival, and additional endpoints need to be investigated.

Post-collection, pre-measurement variables affecting VEGF levels in urine biospecimens.

Angiogenesis, the development and recruitment of new blood vessels, plays an important role in tumour growth and metastasis. Vascular endothelial growth factor (VEGF) is an important stimulator of angiogenesis. Circulating and urinary VEGF levels have been suggested as clinically useful predictors of tumour behaviour, and investigations into these associations are ongoing. Despite recent interest in measuring VEGF levels in patients, little is known about the factors that influence VEGF levels in biospecimens. To begin to address this question, urine samples were collected from patients with solid tumours undergoing radiotherapy and healthy volunteers. Four factors were examined for their effects on VEGF concentrations as measured by chemiluminescent immunoassay: time from sample collection to freezing, number of specimen freeze-thaw cycles, specimen storage tube type and the inclusion or exclusion of urinary sediment. The results of this study indicate that time to freeze up to 4 hrs, number of freeze-thaw cycles between one and five, and different types of polypropylene tubes did not have statistically significant effects on measured urinary VEGF levels. Urinary sediment had higher VEGF levels than supernatant in five of six samples from healthy patients. It is not clear whether there is an active agent in the sediment causing this increase or if the sediment particles themselves are affecting the accuracy of the assay.Therefore, we recommend centrifuging urine, isolating the supernatant, and freezing the sample in polypropylene microcentrifuge tubes or cryogenic vials within 4 hrs of collection.In addition, we recommend the use of samples within five freeze-thaw cycles.