Search

BACKGROUND Little is known about health status and quality of life (QoL) after implantable cardioverter-defibrillator (ICD) generator exchange (GE). METHODS We prospectively followed patients undergoing first-time ICD GE. Serial assessments of health status were performed by administering the 36-Item Short Form Survey (SF-36). RESULTS Mean age was 67.5 ± 14.3 years, left ventricle ejection fraction (LVEF) was 36.5% ± 15.0% and over 40% of the cohort had improved LVEF to > 35% at the time of GE. SF-36 scores were significantly worse in physical/general health domains compared to domains of emotional/social well-being ( P < 0.001 for each comparison). Physical health scores were significantly worse among those with medical comorbidities including diabetes, chronic obstructive pulmonary disease and atrial fibrillation. Mean follow-up was 1.6 ± 0.5 years after GE. Overall SF-36 scores remained stable across all domains during follow-up. Survival at 3 years post-GE was estimated at 80%. Five patients died during follow-up and most deaths were adjudicated as non-arrhythmic in origin. Four patients experienced appropriate ICD shocks after GE, three of whom had LVEF which remains impaired LVEF (i.e., < 35%) at the time of GE. CONCLUSION Patients undergoing ICD GE have significantly worse physical health compared to emotional/social well-being, which is associated with the presence of medical comorbidities. In terms of clinical outcomes, the incidence of appropriate shocks after GE among those with improvement in LVEF is very low, and most deaths post-procedure appear to be non-arrhythmic in origin. These data represent an attempt to more fully characterize the spectrum of QoL and clinical outcomes after GE.

Background: In 2018, CMS required shared decision-making (SDM) with a decision (DA) prior to implantation of a primary prevention cardioverter defibrillator (ICD). Little is known about how DAs should be incorporated, but the implementation strategy may affect the process. Providing DAs prior to the SDM visit may facilitate informed discussion. However, this requires identifying ICD candidates ahead of time which may be logistically challenging. Providing the DA during the office visit requires less administrative effort but may reduce the impact of the DA. Objective: To evaluate the impact of DA timing on SDM outcomes. Methods: Patients referred for ICD implantation were block randomized across 3 clinics to receive the DA 30 minutes prior to, or at the end of the SDM visit. Patients were surveyed on implant day in several SDM domains including knowledge about ICDs, decisional conflict, values-choice concordance and the extent to which patients felt engaged in the decision-making process. Patients who chose not to have an ICD implanted after the SDM visit were surveyed by mail. Implanting physicians were also surveyed to assess perceptions about the impact of the DA. Results: Of 42 randomized patients, 24 completed the survey with 9 who received the DA before and 15 after the SDM visit. Three chose not to have an ICD implanted: 1 received the DA before and 2 after the visit. Though overall knowledge about ICDs was similar between groups (Table), every patient who received the DA before the encounter understood the primary purpose of the ICD, compared with 10/15 who received the DA after the visit. Receiving the DA earlier showed a numerically higher rate of understanding the risk of inappropriate ICD shocks. No significant differences were observed in decisional conflict, values-choice concordance, or reported patient engagement in decision-making. Conclusion: Patients who received a DA prior to the visit had numerically, but not significantly, higher rates of understanding the purpose of the ICD and risk of inappropriate shocks. These pilot data suggest that efforts to provide DAs ahead of time may strengthen SDM interaction and that an implementation strategy is critical to study. Important knowledge gaps remain in both groups, suggesting opportunities to improve SDM for ICDs.

Acute kidney injury (AKI) is a common and serious complication for pediatric cardiac surgery patients associated with increased morbidity, mortality, and length of stay. Current strategies focus on risk reduction and early identification because there are no known preventive or therapeutic agents. Cardiac surgery and cardiopulmonary bypass lyse erythrocytes, releasing free hemoglobin and contributing to oxidative injury. Acetaminophen may prevent AKI by reducing the oxidation state of free hemoglobin.To test the hypothesis that early postoperative acetaminophen exposure is associated with reduced risk of AKI in pediatric patients undergoing cardiac surgery.In this retrospective cohort study, the setting was 2 tertiary referral children's hospitals. The primary and validation cohorts included children older than 28 days admitted for cardiac surgery between July 1, 2008, and June 1, 2016. Exclusion criteria were postoperative extracorporeal membrane oxygenation and inadequate serum creatinine measurements to determine AKI status.Acetaminophen exposure in the first 48 postoperative hours.Acute kidney injury based on Kidney Disease: Improving Global Outcomes serum creatinine criteria (increase by ≥0.3 mg/dL from baseline or at least 1.5-fold more than the baseline [to convert to micromoles per liter, multiply by 88.4]) in the first postoperative week.The primary cohort (n = 666) had a median age of 6.5 (interquartile range [IQR], 3.9-44.7) months, and 341 (51.2%) had AKI. In unadjusted analyses, those with AKI had lower median acetaminophen doses than those without AKI (47 [IQR, 16-88] vs 78 [IQR, 43-104] mg/kg, P .001). In logistic regression analysis adjusting for age, cardiopulmonary bypass time, red blood cell distribution width, postoperative hypotension, nephrotoxin exposure, and Risk Adjustment for Congenital Heart Surgery score, acetaminophen exposure was protective against postoperative AKI (odds ratio, 0.86 [95% CI, 0.82-0.90] per each additional 10 mg/kg). Findings were replicated in the validation cohort (n = 333), who had a median age of 14.1 (IQR, 3.9-158.2) months, and 162 (48.6%) had AKI. Acetaminophen doses were 60 (95% CI, 40-87) mg/kg in those with AKI vs 70 (95% CI, 45-94) mg/kg in those without AKI (P = .03), with an adjusted odds ratio of 0.91 (95% CI, 0.84-0.99) for each additional 10 mg/kg.These results indicate that early postoperative acetaminophen exposure may be associated with a lower rate of AKI in pediatric patients who undergo cardiac surgery. Further analysis to validate these findings, potentially through a prospective, randomized trial, may establish acetaminophen as a preventive agent for AKI.

The efficacy of omega-3 polyunsaturated fatty acids (n-3 PUFAs) in preventing recurrence of atrial fibrillation (AF) is controversial and their effects on inflammation and oxidative stress in this population are not known. This study examined the effects of high-dose marine n-3 PUFAs added to conventional therapy on the recurrence of AF and on markers of inflammation and oxidative stress. Patients with paroxysmal or persistent AF were randomized to n-3 PUFAs (4 g/day; n = 126) or placebo (n = 64) in a 2:1 ratio in a prospective, double-blind, placebo-controlled, parallel group study. The primary outcome was time to recurrence of AF. Secondary outcomes were changes in biomarkers of inflammation (serum interleukin [IL]-6, IL-8, IL-10, tissue necrosis factor alpha, monocyte chemoattractant protein-1, and vascular endothelial growth factor), N-terminal-pro-brain-type natriuretic peptide, and oxidative stress (urinary F2-isoprostanes). AF recurred in 74 patients (58.7%) randomized to n-3 PUFAs and in 30 patients (46.9%) who received placebo; time to recurrence of AF did not differ significantly in the 2 groups (hazard ratio 1.20; 95% confidence interval 0.76 to 1.90, adjusted p = 0.438). Compared with placebo, n-3 PUFAs did not result in clinically meaningful changes in concentrations of inflammatory markers, N-terminal-pro-brain-type natriuretic peptide or F2-isoprostanes. In conclusion, in patients with paroxysmal or persistent AF, treatment with n-3 PUFAs 4 g/day did not reduce the recurrence of AF, nor was it associated with clinically important effects on concentrations of markers of inflammation and oxidative stress. (Clinical trial registration number, NCT 00552084.).

Objective. The Patient-Reported Outcomes Measurement Information System (PROMIS) was developed to standardize measurement of clinically relevant patient-reported outcomes. This study evaluated the reliability and construct validity of select PROMIS static short-form (SF) instruments in women with fibromyalgia. Design. Analysis of baseline data from the Fibromyalgia Activity Study with TENS (FAST), a randomized controlled trial of the efficacy of transcutaneous electrical nerve stimulation. Setting. Dual site, university-based outpatient clinics. Subjects. Women aged 20 to 67 years diagnosed with fibromyalgia. Methods. Participants completed the Revised Fibromyalgia Impact Questionnaire (FIQR) and 10 PROMIS static SF instruments. Internal consistency was calculated using Cronbach alpha. Convergent validity was examined against the FIQR using Pearson correlation and multiple regression analysis. Results. PROMIS static SF instruments had fair to high internal consistency (Cronbach α = 0.58 to 0.94, P

Background Acute myocardial infarction (AMI) is frequently associated with transient hyperglycemia even in patients without pre-existing diabetes. Acute stress can lead to increased blood glucose through the effect of catecholamines on alpha 2A -adrenergic receptors (α 2A -ARs) present in pancreatic islet β-cells. Variation in the gene ( ADRA2A ) that encodes the α 2A -AR affects insulin release and glucose control and may play a particularly important role during times of stress. Methods We performed a retrospective cohort study using de-identified electronic medical records linked to a DNA repository in 521 Caucasians and 55 African-American non-diabetic patients with AMI. We examined the association between admission blood glucose concentrations and ten selected ADRA2A SNPs in Caucasians. Results Three ADRA2A SNPS were associated with stress-induced hyperglycemia in Caucasians. Individuals homozygous for the rs10885122 variant (n=9) had a 23% lower admission glucose (geometric mean [95% CI], 99 [83–118]mg/dl) compared with non-carriers (121 [118–125] mg/dl; n=401; P=0.001). Admission glucose was 14% higher in rs1800544 variant homozygotes (134 [119–150]mg/dl; n=36) compared to non-carriers (118 [115–121]mg/dl; n=290, P=0.046). Furthermore, homozygotes of the rs553668 variant (n=13) had a 13% higher glucose (133 [110–160]mg/dl) compared to non-carriers (118 [115–122]mg/dl; n=366; P=0.056). Haplotypes including these ADRA2A SNPs were associated with higher admission glucose levels. Conclusions Three ADRA2A genetic variants are associated with blood glucose and stress-induced hyperglycemia after AMI in Caucasians.

Fibromyalgia is a condition characterized by chronic widespread muscle pain and fatigue and associated with significant impairment in perceived function and reduced physical performance. The purpose of this study was to determine the degree to which pain and fatigue are associated with perceived function and physical performance in women with fibromyalgia. Hierarchical linear regression determined the contribution of pain and fatigue (Numeric Rating Scale (NRS) for resting, movement and combined) to perceived function (Fibromyalgia Impact Questionnaire Revised - Function Subscale, FIQR-Function), Multidimensional Assessment of Fatigue - Activities of Daily Living (MAF-ADL) and SF-36 Physical Function Subscale (SF-36-PF) and physical performance (6-Minute Walk Test, 6MWT and Five Time Sit To Stand, 5TSTS) while controlling for age, body mass index, pain catastrophizing, fear of movement, anxiety, and depression in women with fibromyalgia (N = 94). For perceived function, movement pain and movement fatigue together better predicted FIQR-function (adjusted R2 = 0.42, p ≤ 0.001); MAF-ADL (adjusted R2 = 0.41, p ≤ 0.001); and SF-36-PF function (adjusted R2 = 0.34, p ≤ 0.001). For physical performance measures, movement pain and fatigue together predicted 6MWT distance (adjusted R2 = 0.42, p ≤ 0.001) and movement fatigue alone predicted performance time on the 5TSTS (adjusted R2 = 0.20, p ≤ 0.001). Pain and fatigue are significantly associated with and explain more than one-third of the variance in perceived function and physical performance in women with fibromyalgia. NIH Clinicaltrials.gov Registration: NCT01888640 . Registered 13 June 2013.