Pathways Linking Post-Traumatic Stress Disorder to Incident Ischemic Heart Disease in Women: Call to Action.

Background: Post-traumatic stress disorder (PTSD) is associated with increased rates of incident ischemic heart disease (IHD) in women. Objectives: The purpose of this study was to determine mechanisms of the PTSD-IHD association in women. Methods: In this retrospective longitudinal cohort study, data were obtained from electronic health records of all U.S. women veterans who were enrolled in Veterans Health Administration care from January 1, 2000 to December 31, 2017. Propensity score matching was used to match women with PTSD to women without PTSD on age, number of prior Veterans Health Administration visits, and presence of various traditional and nontraditional cardiovascular risk factors at index visit. Cox regression was used to model time until incident IHD diagnosis (ie, coronary artery disease, angina, or myocardial infarction) as a function of PTSD and potential mediating risk factors. Diagnoses of IHD, PTSD, and risk factors were defined by International Classification of Diseases-9th or -10th Revision, and/or Current Procedural Terminology codes. Results: PTSD was associated with elevated rates of developing each risk factor. Traditional risk factors (hypertension, hyperlipidemia, smoking, diabetes) accounted for 24.2% of the PTSD-IHD association, psychiatric risk factors (eg, depression, anxiety, substance use disorders) accounted for 33.8% of the association, and all 13 risk factors accounted for 48.5% of the association. Conclusions: Traditional IHD risk factors explained a quarter of the PTSD-IHD association in women veterans, and over half of the risk of IHD associated with PTSD remained unexplained even when adjusting for a wide range of risk factors. To be actionable, factors underlying the remaining PTSD-IHD association warrant timely investigation.

Cryoablation of atrial fibrillation in "very severe" obese patients (BMI ≥ 40): Indications, feasibility, procedural safety and efficacy, and clinical outcome (the ICE-Obese Extreme).

BACKGROUND: Management of atrial fibrillation (AF) in very severe obese patients is challenging. Cryoballoon ablation (CBA) represents an effective rhythm control strategy. However, data in this patient group were limited. METHODS: Highly symptomatic AF patients with body mass index (BMI) ≥ 40 kg/m2 who had failed antiarrhythmic drug therapy and electrocardioversion and failure to achieve targeted body-weight-reduction underwent CBA. RESULTS: Data of 72 very severe obese AF patients (Group A) and 129 AF patients with normal BMI (Group B, BMI < 25 kg/m2) were consecutively collected. Group A had significantly younger age (60.6 ± 10.4 vs. 69.2 ± 11.2 years), higher BMI (44.3 ± 4.3 vs. 22.5 ± 1.6 kg/m2). Procedural pulmonary vein isolation (PVI) was successful in all patients (2 touch-up ablation in Group A). Compared to Group B, Group A had similar procedural (61.3 ± 22.6 vs. 57.5 ± 19 min), similar fluoroscopy time (10.1 ± 5.5 vs. 9.2 ± 4.8 min) but significantly higher radiation dose (2852 ± 2095 vs. 884 ± 732 µGym2). We observed similar rates of real-time-isolation (78.6% vs. 78.5%), single-shot-isolation (86.5% vs. 88.8%), but significantly longer time-to-sustained-isolation (53.5 ± 33 vs. 43.2 ± 25 s). There was significantly higher rate of puncture-site-complication (6.9% vs. 1.6%) in Group A. One-year clinical success in paroxysmal AF was (Group A: 69.4% vs. Group B: 80.2%; p < .001), in persistent AF was (Group A: 58.1% vs. Group B: 62.8%; p = .889). In Re-Do procedures Group A had a numerically lower PVI durability (75.0% vs. 83.6%, p = .089). CONCLUSION: For very severe obese AF patients, CBA appears feasible, leads to relatively good clinical outcome.

Occurrence of proliferative myositis after COVID-19 vaccination: A case report.

Proliferative myositis (PM) is a benign intramuscular tumor that might mimic a malignant one due to its unusual pseudosarcomatous inflammatory nature. In this report, we describe a patient who developed PM after vaccination with Sinopharm coronavirus disease (COVID-19) vaccine. A 73 years old man was admitted due to rapidly-growing painful mass in his left thigh from a few days ago, curtailing his walking. He received a recent COVID-19 vaccination (Sinopharm COVID-19 vaccine) about 5 days before the beginning of symptoms. No history of trauma was present. On physical exam, a round firm mass was found in lateral side of mid portion of left thigh within the muscle with tenderness on palpation. An oval-shaped well-defined intramuscular mass measured 15 × 41 mm was noted in vastus lateralis muscle in ultrasonography. Left thigh magnetic resonance imaging (MRI) showed a well-defined intramuscular mass with a definite margin of 19 × 39 mm. Finally, ultrasound (US)-guided core needle biopsy showed muscular tissue with a loose mass composed of plump fibroblasts and myofibroblasts and large ganglion-like cell with abundant amphophilic to basophilic cytoplasm, vesicular nuclei and prominent nucleoli. Pathology report showed a very rare case identified as proliferative myositis. It should be noted that we cannot make a direct link between these 2 events. PM is an extremely rare entity; however, its relation with COVID-19 vaccination might be a coincidence.

A self-assembled implantable microtubular pacemaker for wireless cardiac electrotherapy.

The current cardiac pacemakers are battery dependent, and the pacing leads are prone to introduce valve damage and infection, plus a complete pacemaker retrieval is needed for battery replacement. Despite the reported wireless bioelectronics to pace the epicardium, open-chest surgery (thoracotomy) is required to implant the device, and the procedure is invasive, requiring prolonged wound healing and health care burden. We hereby demonstrate a fully biocompatible wireless microelectronics with a self-assembled design that can be rolled into a lightweight microtubular pacemaker for intravascular implantation and pacing. The radio frequency was used to transfer energy to the microtubular pacemaker for electrical stimulation. We show that this pacemaker provides effective pacing to restore cardiac contraction from a nonbeating heart and have the capacity to perform overdrive pacing to augment blood circulation in an anesthetized pig model. Thus, this microtubular pacemaker paves the way for the minimally invasive implantation of leadless and battery-free microelectronics.

Pulsed Field Versus Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation: Efficacy, Safety, and Long-Term Follow-Up in a 400-Patient Cohort.

BACKGROUND: The cryoballoon (CB) represents the gold standard single-shot device for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). Single-shot pulsed field PVI ablation (nonthermal, cardiac tissue selective) has recently entered the arena. We sought to compare procedural data and long-term outcome of both techniques. METHODS: Consecutive AF patients who underwent pulsed field ablation (PFA) and CB-based PVI were enrolled. CB PVI was performed using the second-generation 28-mm CB; PFA was performed using a 31/35-mm pentaspline catheter. Success was defined as freedom from atrial tachyarrhythmia after a 3-month blanking period. RESULTS: Four hundred patients were included (56.5% men; 60.8% paroxysmal AF; age 70 [interquartile range, 59-77] years), 200 in each group (CB and PFA), and baseline characteristics did not differ. Acute PVI was achieved in 100% of PFA and in 98% (196/200) of CB patients (P=0.123; 4 touch-up ablations). Median procedure time was significantly shorter in PFA (34.5 [29-40] minutes) versus CB (50 [45-60] minutes; P<0.001), fluoroscopy time was similar. Overall procedural complications were 6.5% in CB and 3.0% in PFA (P=0.1), driven by a higher rate of phrenic nerve palsies using CB. The 1-year success rates in paroxysmal AF (CB, 83.1%; PFA, 80.3%; P=0.724) and persistent AF (CB, 71%; PFA, 66.8%; P=0.629) were similar for both techniques. CONCLUSIONS: PFA compared with CB PVI shows a similar procedural efficacy but is associated with shorter procedure time and no phrenic nerve palsies. Importantly, 12-month clinical success rates are favorable but not different between both groups.

Health-related quality of life impacts upon 5-year survival after coronary artery bypass surgery.

BACKGROUND: Poor preoperative health-related quality of life (HRQoL) has been associated with reduced short-term survival after coronary artery bypass graft (CABG) surgery; however, its impact on long-term mortality is unknown. This study's objective was to determine if baseline HRQoL status predicts 5-year post-CABG mortality. METHODS: This prespecified, randomized on/off bypass follow-up study (ROOBY-FS) subanalysis compared baseline patient characteristics and HRQoL scores, obtained from the Seattle Angina Questionnaire (SAQ) and Veterans RAND Short Form-36 (VR-36), between 5-year post-CABG survivors and nonsurvivors. Standardized subscores were calculated for each questionnaire. Multivariable logistic regression assessed whether HRQoL survey subcomponents independently predicted 5-year mortality (p ≤ .05). RESULTS: Of the 2203 ROOBY-FS enrollees, 2104 (95.5%) completed baseline surveys. Significant differences between 5-year post-CABG deaths (n = 286) and survivors (n = 1818) included age, history of chronic obstructive pulmonary disease, stroke, peripheral vascular disease, renal dysfunction, diabetes, lower left ventricular ejection fraction, atrial fibrillation, depression, non-White race/ethnicity, lower education status, and off-pump CABG. Adjusting for these factors, baseline VR-36 physical component summary score (p = .01), VR-36 mental component summary score (p < .001), and SAQ physical limitation score (p = .003) were all associated with 5-year all-cause mortality. CONCLUSIONS: Pre-CABG HRQoL scores may provide clinically relevant prognostic information beyond traditional risk models and prove useful for patient-provider shared decision-making and enhancing pre-CABG informed consent.

Primary intradural extramedullary Ewing sarcoma in the lumbar area: A case report.

Primary intradural extramedullary Ewing sarcoma (IEES) is the rarest type of Ewing sarcoma. Extreme caution is required for the diagnosis of IEES because benign intradural spinal tumors can be mistaken for IEES in the early stages of imaging and clinical evaluation. IEES tumors have no standardized treatment guidelines because of the lack of research on the therapeutic aspects of these tumors. Herein, we present a case of primary IEES in a male adolescent with a fast progression of the disease. Diagnosis of IEES was suspected with imaging (computed tomography scan and lumbosacral magnetic resonance imaging) and was confirmed with histology and immunohistochemistry (positive reactivity for CD99 and FLI1). He was successfully treated with surgical intervention with no radiotherapy or chemotherapy. Imaging studies are helpful in making the initial diagnosis of intradural extramedullary Ewing sarcoma. Surgery is considered to be a successful method of treatment for this condition.

Primary synovial sarcoma of the prostate: A case report and literature review.

Synovial sarcoma arising from the prostate is extremely rare. Synovial sarcoma of the prostate is usually identified at a late stage and makes the treatment challenging. Here, we report a case of 30-year-old man with advanced metastatic synovial sarcoma of prostate gland at diagnosis and his poor prognosis.

Predictive ability of six obesity measures to identify 7-year fatal and non-fatal cardiovascular events: A population-based cohort study.

Background: Globally, most people die from cardiovascular diseases. We aimed to compare predictive ability of six obesity indices, including body mass index, waist circumference, waist-to-hip ratio, waist-to-height ratio, conicity index, and abdominal volume index, to identify people at risk of fatal and non-fatal cardiovascular events, in a cohort study. Methods: We studied 5147 participants in a baseline population-based cohort study conducted in northern Iran. The obesity measures were calculated in enrollment phase (2009-2010), and the cardiovascular events were recorded during a 7-year follow-up phase (2010-2017). Receiver operating characteristic (ROC) analyses and Cox hazard regression models were applied, considering the obesity measures as predictors, and the 7-year cardiovascular events as outcomes. Multiple Cox models were adjusted by age, prior history of cardiovascular diseases, chronic kidney diseases, insulin resistance, diabetes mellitus, dyslipidemia, hypertension, and smoking status. Results: Conicity index showed the highest performance in predicting 7-year fatal and non-fatal cardiovascular events with areas under the ROC curve of 0.77 [95% confidence interval: 0.71-0.82], and 0.63 [0.59-0.68] in men, and 0.80 [0.74-0.87], and 0.65 [0.60-0.71] in women, respectively. In multiple Cox models, the obesity measures had no significant associations with cardiovascular events in women. In men, only waist-to-height ratio was independently associated with 7-year non-fatal cardiovascular events (hazard ratio: 1.19 [95% confidence interval: 1.01-1.38]). Conclusions: Although waist-to-height ratio had an independent association with 7-year non-fatal cardiovascular events in men, conicity index showed the best ability to predict 7-year fatal and non-fatal cardiovascular events in our study.

Military Sexual Trauma and Adverse Mental and Physical Health and Clinical Comorbidity in Women Veterans.

INTRODUCTION: Military sexual trauma (MST)-exposure to sexual harassment or assault during military service-is a major health priority for the Veterans Health Administration (VHA). We examined the health correlates of MST in the largest sample of U.S. women veterans studied to date. METHODS: Using national VHA electronic medical record data, we identified 502,199 women veterans who enrolled in the VHA between January 1, 2000, and December 31, 2017, had at least one VHA visit, and were screened for MST (exclusive of those who declined to answer the screening). We conducted logistic regression analyses to examine associations of a positive MST screen with various mental and physical health conditions-defined by administrative diagnostic codes-and comorbidity of mental and/or physical health conditions. Models were adjusted for demographic and military service characteristics, along with duration in the VHA. RESULTS: Approximately 26% (n = 130,738) of women veterans screened positive for MST. In fully adjusted models, a positive MST screen was associated with greater risk of having all mental and physical health conditions examined, except cancer-related conditions, ranging from 9% greater odds of rheumatic disease to 5.4 times greater odds of post-traumatic stress disorder. MST was also associated with greater comorbidity, including greater odds of having ≥2 mental health conditions (odds ratio [OR], 3.28; 99% confidence interval [CI], 3.20-3.37), having ≥2 physical health conditions (OR, 1.26; 99% CI, 1.22-1.29), and having ≥1 mental health condition and ≥1 physical health condition (OR, 2.05; 99% CI, 2.00-2.11). CONCLUSIONS: Findings suggest that MST is common in women veterans and may play a role in the clinical complexity arising from comorbid conditions.

COVID-19 associated mortality and cardiovascular disease outcomes among US women veterans.

The burden of COVID-19 has been noted to be disproportionately greater in minority women, a population that is nevertheless still understudied in COVID-19 research. We conducted an observational study to examine COVID-19-associated mortality and cardiovascular disease outcomes after testing (henceforth index) among a racially diverse adult women veteran population. We assembled a retrospective cohort from a Veterans Affairs (VA) national COVID-19 shared data repository, collected between February and August 2020. A case was defined as a woman veteran who tested positive for SARS-COV-2, and a control as a woman veteran who tested negative. We used Kaplan-Meier curves and the Cox proportional hazards model to examine the distribution of time to death and the effects of baseline predictors on mortality risk. We used generalized linear models to examine 60-day cardiovascular disease outcomes. Covariates studied included age, body mass index (BMI), and active smoking status at index, and pre-existing conditions of diabetes, chronic kidney disease (CKD), chronic obstructive pulmonary disease (COPD), and a history of treatment with antiplatelet or anti-thrombotic drug at any time in the 2 years prior to the index date. Women veterans who tested positive for SARS-CoV-2 had 4 times higher mortality risk than women veterans who tested negative (Hazard Ratio 3.8, 95% Confidence Interval CI 2.92 to 4.89) but had lower risk of cardiovascular events (Odds Ratio OR 0.78, 95% CI 0.66 to 0.92) and developing new heart disease conditions within 60 days (OR 0.67, 95% CI 0.58 to 0.77). Older age, obesity (BMI > 30), and prior CVD and COPD conditions were positively associated with increased mortality in 60 days. Despite a higher infection rate among minority women veterans, there was no significant race difference in mortality, cardiovascular events, or onset of heart disease. SARS-CoV-2 infection increased short-term mortality risk among women veterans similarly across race groups. However, there was no evidence of increased cardiovascular disease incidence in 60 days. A longer follow-up of women veterans who tested positive is warranted.

New-onset postoperative atrial fibrillation impact on 5-year clinical outcomes and costs.

OBJECTIVE: The impact of new-onset postoperative atrial fibrillation (POAF) following coronary artery bypass grafting (CABG) surgery on long-term clinical outcomes and costs is not known. This subanalysis of the Veterans Affairs "Randomized On/Off Bypass Follow-up Study" compared 5-year outcomes and costs between patients with and without POAF. METHODS: Of the 2203 veterans in the study, 100 with pre-CABG atrial fibrillation (93) or missing data (7) were excluded (4.8%). Unadjusted and risk-adjusted outcomes were compared between new-onset POAF (n = 551) and patients without POAF (n = 1552). Five-year clinical outcomes included mortality, major adverse cardiovascular events (MACE, comprising mortality, repeat revascularization, and myocardial infarction), MACE subcomponents, stroke, and costs. A stringent P value of ≤.01 was required to identify statistical significance. RESULTS: Patients with POAF were older and had more complex comorbidities. Unadjusted 5-year all-cause mortality was 16.3% POAF versus 11.9% no-POAF, P = .008. Unadjusted cardiac-mortality was 7.4% versus 4.8%, P = .022. There were no differences between groups in any other unadjusted outcomes including MACE or stroke. After risk adjustment, there were no significant differences between groups in 5-year all-cause mortality (POAF odds ratio, 1.19; 99% confidence interval, 0.81-1.75) or cardiac mortality (odds ratio, 1.51, 99% confidence interval, 0.88-2.60). Adjusted first-year post-CABG costs were $15,300 greater for patients with POAF, but 2- through 5-year costs were similar. CONCLUSIONS: No 5-year risk-adjusted outcome differences were found between patients with and without POAF after CABG. Although first-year costs were greater in patients with POAF, this difference did not persist in subsequent years.

Clinical and Angiographic Predictors of Patient-Reported Angina 1 Year After Coronary Artery Bypass Graft Surgery.

BACKGROUND: Studies of the relationship between patient self-reported angina symptoms using the Seattle Angina Questionnaire (SAQ) and angiographic findings after coronary artery bypass grafting surgery (CABG) are lacking. Nested within a randomized controlled trial, this prospective observational cohort comparison study aimed to assess which clinical characteristics and angiographic findings are associated with self-reported angina 1 year after CABG. METHODS AND RESULTS: Patients from the ROOBY trial (Randomized On/Off Bypass) with protocol-specified 1-year post-CABG coronary angiography and SAQ assessments were included (n=1258). Patients reporting no angina (62.3%) within 4 weeks before the 1-year post-CABG study visit on the SAQ angina frequency domain were compared with patients reporting angina (37.7%). Multivariable modeling identified clinical variables and angiographic findings associated with angina. Sequential univariate and multivariable modeling found the following demographic and clinical factors were associated with angina after CABG: younger age, worse preoperative SAQ angina frequency score, smoking, diabetes mellitus, and pre-CABG depression. The only 1-year angiographic finding significantly associated with angina was incomplete revascularization of the left anterior descending (LAD) territory. Graft occlusions, incomplete revascularization of non-LAD territories, and ≥70% lesions in nonrevascularized native coronary arteries were not correlated with the presence or absence of angina. Further, only 30.6% of subjects reporting angina at 1 year had a residual major coronary artery stenosis of ≥70%. CONCLUSIONS: Self-reported angina 1 year after CABG is associated with younger age, worse baseline SAQ angina frequency score, smoking, diabetes mellitus, and depression. The only angiographic finding associated with angina was a poorly revascularized LAD territory. These results may help guide physicians when counseling patients on expected improvements in angina symptoms and in making decisions regarding the need for coronary angiography after CABG. Whether intensive treatment of these comorbidities improves post-CABG angina symptoms requires further study. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00032630.

Comparison of Outcomes and Costs Associated With Aspirin ± Clopidogrel After Coronary Artery Bypass Grafting.

Optimal antiplatelet therapy after coronary artery bypass graft (CABG) surgery remains controversial. This study evaluated the role of dual antiplatelet therapy using aspirin and clopidogrel (DAPT) versus antiplatelet therapy using aspirin only (ASA) on post-CABG clinical outcomes and costs. In the Department of Veterans Affairs Randomized On/Off Bypass (ROOBY) trial, clopidogrel use after CABG was prospectively collected beginning in year 2 of this study to include 1,525 of the 2,203 original ROOBY patients who received aspirin after CABG. Discretionarily, surgeons after CABG administered either DAPT or ASA treatments. The ROOBY trial's primary 30-day composite (mortality or perioperative morbidity), 1-year composite (all-cause death, repeat revascularization, or nonfatal myocardial infarction), and costs were compared for these 2 strategies. Of the 1,525 subjects, 511 received DAPT and 1,014 received ASA. DAPT subjects, compared with ASA subjects, had lower rates of preoperative left ventricular ejection fraction of ≥45% (78.8% vs 85.7%, p <0.001), on-pump CABG (36.6% vs 57.1%, p = 0.001), and endoscopic vein harvesting (30.0% vs 42.8%, p <0.001). ASA patients were more likely to have earlier aspirin administration and receive 325 versus 81 mg dosages. The 30-day composite outcome rate was significantly lower for DAPT patients compared with ASA patients (3.3% vs 7.1%, p = 0.003), but the 1-year composite outcome was equal between the 2 groups (12.0% vs12.0%, p = 1.0). At 1 year, there were no cost differences between the 2 groups. Propensity analyses did not significantly alter the results. In conclusion, DAPT appeared safe and was associated with fewer 30-day adverse outcomes than aspirin only and with no 1-year outcome or cost differences.

Incidence of Myocardial Infarction After High-Risk Vascular Operations in Adults.

IMPORTANCE: Advances in perioperative cardiac management and an increase in the number of endovascular procedures have made significant contributions to patients and postoperative myocardial infarction (POMI) risk following high-risk vascular procedures. Whether these changes have translated into real-world improvements in POMI incidence remain unknown. OBJECTIVE: To examine the temporal trends of myocardial infarction (MI) following high-risk vascular procedures. DESIGN, SETTING, AND PARTICIPANTS: A retrospective cohort study was performed using data collected from January 1, 2005, to December 31, 2013, in the American College of Surgeons National Surgery Quality Improvement Program database, to which participating hospitals across the United States report their preoperative, operative, and 30-day outcome data. A total of 90 303 adults who underwent a high-risk vascular procedure-open aortic surgery or infrainguinal bypass-during the study period were identified. Patients were divided into cohorts based on their year of operation, and their baseline cardiac risk factors and incidence of POMI were compared. Cases from 2005 to 2014 in the database were eligible for inclusion if one of their Current Procedural Terminology codes matched any of the operations identified as a high-risk vascular procedure. Data analysis took place from August 1, 2016, to November 15, 2016. EXPOSURES: The main exposure was the year of the operation. Other variables of interest included demographics, comorbidities, and other risk factors for MI. MAIN OUTCOMES AND MEASURES: Primary outcome of interest was the incidence of POMI. RESULTS: Of the 90 303 patients included in the study, 22 836 (25.3%) had undergone open aortic surgery and 67 467 (74.7%) had had infrainguinal bypass. The open aortic cohort comprised 16 391 men (71.9%), had a mean (SD) age of 69.1 (11.5) years, and was predominantly white (18 440 patients [80.8%] self-identified as white race/ethnicity). The infrainguinal bypass cohort included 41 845 men (62.1%), had a mean (SD) age of 66.7 (11.7) years, and had 51 043 patients (75.7%) who self-identified as white race/ethnicity. During the study period, patients who underwent open aortic procedures were more likely to be classified as American Society of Anesthesiologists class IV (7426 patients [32.6%] vs 15 683 [23.3%] for the infrainguinal bypass cohort) or class V (1131 [5.0%] vs 206 [0.3%]; P < .001) and to undergo emergency procedures (4852 [21.3%] vs 4954 [7.3%]; P < .001). The open aortic procedure cohort also experienced significantly higher actual incidence of POMI (464 [3.0%] vs 1270 [1.9%]; P < .001). From 2009 to 2014, the incidence of POMI demonstrated no substantial temporal change (2.7% in 2009 to 3.1% in 2014; P = .64 for trend). Postoperative MI was consistently associated with poor prognosis, with a 3.62-fold (95% CI, 2.25-5.82) to 11.77-fold (95% CI, 6.10-22.72) increased odds of cardiac arrest and a 3.01-fold (95% CI, 2.08-4.36) to 6.66-fold (95% CI, 4.66-9.52) increased odds of mortality. CONCLUSIONS AND RELEVANCE: The incidence of MI did not significantly decrease in the past decade and has been consistently associated with worse clinical outcomes. Further inquiry into why advanced perioperative care did not reduce cardiac complications is important to quality improvement efforts.

Effect of Low-Frame Invasive Coronary Angiography on Radiation and Image Quality.

Invasive coronary angiography (ICA) uses harmful x-ray energy. To date, there are no studies evaluating the effect of performing ICA at lower than the standard 15 frames per second (f/s) on radiation dose and image quality. In this study, we investigated the effect of performing ICAs at 7.5 f/s as opposed to the standard 15 f/s on radiation exposure and image quality. Thirty-nine patients referred for ICA for clinical indications were assigned to have their ICA performed at 7.5 f/s or 15 f/s in a 2:1 ratio, respectively. All studies were performed by one experienced operator in the same laboratory. Magnification, table height, collimation, number of images, and specific angles for image acquisition were kept constant to account for these variables that also effect radiation. Studies performed at 7.5 f/s had significantly less radiation exposure than those performed at 15 f/s (252.2 mGy vs 433.7 mGy, p <0.01). In addition, radiation per unit time was also significantly reduced in the 7.5 f/s versus the 15 f/s group (140.0 mGy/min vs 254.7 mGy/min, p <0.01). Image quality was evaluated by an experienced operator blinded to the goals of the study; allstudies were graded as good to excellent. In conclusion, performing ICA at 7.5 f/s versus 15 f/s significantly reduces x-ray exposure without compromising image quality. The results of this single-center study warrant a larger randomized clinical trial.

Postoperative atrial fibrillation impacts on costs and one-year clinical outcomes: the Veterans Affairs Randomized On/Off Bypass Trial.

BACKGROUND: New-onset postoperative atrial fibrillation (POAF) after coronary artery bypass graft surgery (CABG) is associated with worse in-hospital morbidity and mortality, extended hospital stays, and higher costs. Beyond the initial hospital discharge, the cost and outcomes of POAF have not been well studied. METHODS: For CABG patients with and without new-onset POAF, a retrospective propensity-matched, multivariable regression analysis was performed to compare 1-year outcomes (including health-related quality of life [HRQoL] scores and mortality rates) and costs (standardized to 2010 dollars). Regression models controlled for site and patient factors, with propensity matching used to adjust for differences in POAF versus no-POAF patients' risk profiles. RESULTS: Using the existing CABG trial database, 2,096 patient records were analyzed, including POAF patients (n = 549) versus no-POAF patients (n = 1,547). For the index CABG hospitalization, POAF patients had longer postoperative length of stay (+3.9 days) and higher discharge costs (+$13,993) than no-POAF patients. At 1 year, POAF patients had more than twice the adjusted odds of dying (p < 0.01), with higher 1-year total cumulative costs. This 1-year cost difference (+$15,593) was largely attributable to hospital-based costs during the index surgery hospitalization. There was no difference in 1-year HRQoL scores (or HRQoL score changes) between POAF patients and no-POAF patients. CONCLUSIONS: Compared with no-POAF patients, POAF patients had higher discharge and 1-year costs along with higher 1-year mortality rates, but no differences were observed in 1-year HRQoL scores. Additional research appears warranted to improve the longer-term survival rates for POAF CABG patients, targeting future POAF-specific postdischarge interventions.

Simplification to coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus continuation of ritonavir-boosted protease inhibitor with emtricitabine and tenofovir in adults with virologically suppressed HIV (STRATEGY-PI): 48 week results of a randomised, open-label, phase 3b, non-inferiority trial.

BACKGROUND: Patients with HIV on antiretroviral therapy might benefit from regimen simplification to reduce pill burden and dosing frequency. We aimed to assess the safety and efficacy of simplifying the treatment regimen for adults with virologically suppressed HIV infection from a ritonavir-boosted protease inhibitor and emtricitabine plus tenofovir disoproxil fumarate (tenofovir) regimen to coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir. METHODS: STRATEGY-PI is a 96 week, international, multicentre, randomised, open-label, phase 3b trial in which HIV-infected adults with a plasma HIV-1 RNA viral load of less than 50 copies per mL for at least 6 months who were taking a ritonavir-boosted protease inhibitor with emtricitabine plus tenofovir were randomly assigned (2:1) either to switch to coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir or to continue on their existing regimen. Key eligibility criteria included no history of virological failure, no resistance to emtricitabine and tenofovir, and creatinine clearance of 70 mL/min or higher. Neither participants nor investigators were masked to group allocation. The primary endpoint was the proportion of participants with a viral load of less than 50 copies per mL at week 48, based on a US Food and Drug Administration snapshot algorithm for the modified intention-to-treat population, which excluded major protocol violations (prohibited resistance or not receiving a protease inhibitor at baseline). We prespecified non-inferiority with a 12% margin; if non-inferiority was established, superiority was tested as per a prespecified sequential testing procedure. This trial is registered at ClinicalTrials.gov, number NCT01475838. FINDINGS: Between Dec 12, 2011, and Dec 20, 2012, 433 participants were randomly assigned and received at least one dose of study drug. Of these participants, 293 were assigned to switch to the simplified regimen (switch group) and 140 to remain on their existing regimen (no-switch group); after exclusions, 290 and 139 participants, respectively, were analysed in the modified intention-to-treat population. At week 48, 272 (93·8%) of 290 participants in the switch group maintained a viral load of less than 50 copies per mL, compared with 121 (87·1%) of 139 in the no-switch group (difference 6·7%, 95% CI 0·4-13·7; p=0·025). The statistical superiority of the simplified regimen was mainly caused by a higher proportion of participants in the no-switch group than in the switch group discontinuing treatment for non-virological reasons; virological failure was rare in both groups (two [1%] of 290 vs two [1%] of 139). We did not detect any treatment-emergent resistance in either group. Adverse events leading to discontinuation were rare in both groups (six [2%] of 293 vs four [3%] of 140). Switching to the simplified regimen was associated with a small, non-progressive increase from baseline in serum creatinine concentration. Nausea was more common in the switch group than in the no-switch group, but rates of diarrhoea and bloating decreased compared with baseline from week 4 to week 48 in the switch group, whereas there were generally no changes for these symptoms in the no-switch group. INTERPRETATION: Coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir might be a useful regimen simplification option for virologically supressed adults with HIV taking a multitablet ritonavir-boosted protease inhibitor regimen. FUNDING: Gilead Sciences.