Ambulatory Cohort Research Articles

Serum Neprilysin and Recurrent Admissions in Patients With Heart Failure.

BackgroundOur aim was to evaluate the association between the soluble form of neprilysin (sNEP) levels and long‐term all‐cause, cardiovascular, and acute heart failure (AHF) recurrent admissions in an ambulatory cohort of patients with heart failure. sNEP has emerged as a new biomarker with promising implications for prognosis and therapy in patients with heart failure. Reducing the recurrent admission rate of heart failure patients has become an important target of public health planning strategies.Methods and ResultsWe measured sNEP levels in 1021 consecutive ambulatory heart failure patients. End points were the number of all‐cause, cardiovascular, and AHF hospitalizations during follow‐up. We used covariate‐adjusted incidence rate ratios to identify associations. At a median follow‐up of 3.4 years (interquartile range: 1.8–5.7), 391 (38.3%) patients died, 477 (46.7%) patients had 1901 all‐cause admissions, 324 (31.7%) patients had 770 cardiovascular admissions, and 218 (21.4%) patients had 488 AHF admissions. The medians for sNEP and amino‐terminal pro‐brain natriuretic peptide were 0.64 ng/mL (interquartile range: 0.39–1.22) and 1248 pg/mL (interquartile range: 538–2825), respectively. In a multivariate setting, the adjusted incidence rate ratios for the top (>1.22 ng/mL) versus the bottom (≤0.39 ng/mL) quartiles of sNEP were 1.37 (95% confidence interval: 1.03–1.82), P=0.032; 1.51 (95% confidence interval: 1.10–2.06), P=0.010; and 1.51 (95% confidence interval: 1.05–2.16), P=0.026 for all‐cause, cardiovascular, and AHF admissions, respectively.ConclusionsElevated sNEP levels predicted an increased risk of recurrent all‐cause, cardiovascular, and AHF admissions in ambulatory patients with heart failure.

NO MAGGIC IN PREDICTING HEART FAILURE READMISSIONS

Background: Readmission for acute decompensated heart failure represents a significant burden to healthcare in the United States with nearly a quarter of patients being readmitted by 30 days. Here, we evaluate the ability of two robust risk tools derived from ambulatory cohorts, the MAGGIC score and

Incremental Yield of Including Determine-TB LAM Assay in Diagnostic Algorithms for Hospitalized and Ambulatory HIV-Positive Patients in Kenya.

BackgroundDetermine-TB LAM assay is a urine point-of-care test useful for TB diagnosis in HIV-positive patients. We assessed the incremental diagnostic yield of adding LAM to algorithms based on clinical signs, sputum smear-microscopy, chest X-ray and Xpert MTB/RIF in HIV-positive patients with symptoms of pulmonary TB (PTB).MethodsProspective observational cohort of ambulatory (either severely ill or CD4<200cells/μl or with Body Mass Index<17Kg/m2) and hospitalized symptomatic HIV-positive adults in Kenya. Incremental diagnostic yield of adding LAM was the difference in the proportion of confirmed TB patients (positive Xpert or MTB culture) diagnosed by the algorithm with LAM compared to the algorithm without LAM. The multivariable mortality model was adjusted for age, sex, clinical severity, BMI, CD4, ART initiation, LAM result and TB confirmation.ResultsAmong 474 patients included, 44.1% were severely ill, 69.6% had CD4<200cells/μl, 59.9% had initiated ART, 23.2% could not produce sputum. LAM, smear-microscopy, Xpert and culture in sputum were positive in 39.0% (185/474), 21.6% (76/352), 29.1% (102/350) and 39.7% (92/232) of the patients tested, respectively. Of 156 patients with confirmed TB, 65.4% were LAM positive. Of those classified as non-TB, 84.0% were LAM negative. Adding LAM increased the diagnostic yield of the algorithms by 36.6%, from 47.4% (95%CI:39.4–55.6) to 84.0% (95%CI:77.3–89.4%), when using clinical signs and X-ray; by 19.9%, from 62.2% (95%CI:54.1–69.8) to 82.1% (95%CI:75.1–87.7), when using clinical signs and microscopy; and by 13.4%, from 74.4% (95%CI:66.8–81.0) to 87.8% (95%CI:81.6–92.5), when using clinical signs and Xpert. LAM positive patients had an increased risk of 2-months mortality (aOR:2.7; 95%CI:1.5–4.9).ConclusionLAM should be included in TB diagnostic algorithms in parallel to microscopy or Xpert request for HIV-positive patients either ambulatory (severely ill or CD4<200cells/μl) or hospitalized. LAM allows same day treatment initiation in patients at higher risk of death and in those not able to produce sputum.

INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) Profiling Identifies Ambulatory Patients at High Risk on Medical Therapy After Hospitalizations for Heart Failure.

INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) profiles provide important prognostic information for patients with advanced heart failure (HF) receiving mechanical support. The value of INTERMACS profiling has not been shown for patients followed on medical therapy for advanced HF at centers that also offer mechanical circulatory support. This prospective, observational study enrolled 166 patients with chronic New York Heart Association class III-IV HF, ejection fraction ≤30%, and ≥1 HF hospitalization in the previous year, excluding patients listed for transplant or receiving chronic intravenous inotropic therapy. Subjects were followed for at least 12 months or until death, mechanical support, or transplant. Baseline features, quality of life, and outcomes were compared according to INTERMACS profile. Mean age was 57 years, ejection fraction 18%, and 57% had HF >5 years, whereas 23% of subjects were INTERMACS profile 4, 32% profile 5, and 45% profile 6/7. At 1 year, only 47% of this ambulatory advanced HF cohort remained alive on medical therapy. Patients in INTERMACS profile 4 were more likely to die or require mechanical support, with only 52% of these patients alive without support after the first 6 months. Profile 6/7 patients had 1-year survival of 84%, similar to outcomes for contemporary destination left ventricular assist device recipients. Quality of life using the indexed EuroQol score was poor across profiles 4 to 7, although severe limitation was less common than for ambulatory patients enrolled in INTERMACS before ventricular assist device implantation. Ambulatory patients with systolic HF, a heavy symptom burden, and at least 1 recent HF hospitalization are at high risk for death or left ventricular assist device rescue. INTERMACS profiles help identify ambulatory patients with advanced HF who may benefit from current mechanical support devices under existing indications.

Plasma CXCL10, sCD163 and sCD14 Levels Have Distinct Associations with Antiretroviral Treatment and Cardiovascular Disease Risk Factors.

We investigate the associations of three established plasma biomarkers in the context of HIV and treatment-related variables including a comprehensive cardiovascular disease risk assessment, within a large ambulatory HIV cohort. Patients were recruited in 2010 to form the Royal Perth Hospital HIV/CVD risk cohort. Plasma sCD14, sCD163 and CXCL10 levels were measured in 475 consecutive patients with documented CVD risk (age, ethnicity, gender, smoking, blood pressure, BMI, fasting metabolic profile) and HIV treatment history including immunological/virological outcomes. The biomarkers assessed showed distinct associations with virological response: CXCL10 strongly correlated with HIV-1 RNA (p<0.001), sCD163 was significantly reduced among ‘aviraemic’ patients only (p = 0.02), while sCD14 was unaffected by virological status under 10,000 copies/mL (p>0.2). Associations between higher sCD163 and protease inhibitor therapy (p = 0.05) and lower sCD14 with integrase inhibitor therapy (p = 0.02) were observed. Levels of sCD163 were also associated with CVD risk factors (age, ethnicity, HDL, BMI), with a favourable influence of Framingham score <10% (p = 0.04). Soluble CD14 levels were higher among smokers (p = 0.002), with no effect of other CVD risk factors, except age (p = 0.045). Our findings confirm CXCL10, sCD163 and sCD14 have distinct associations with different aspects of HIV infection and treatment. Levels of CXCL10 correlated with routinely monitored variables, sCD163 levels reflect a deeper level of virological suppression and influence of CVD risk factors, while sCD14 levels were not associated with routinely monitored variables, with evidence of specific effects of smoking and integrase inhibitor therapy warranting further investigation.

Postoperative Complications in Pediatric Tonsillectomy and Adenoidectomy in Ambulatory vs Inpatient Settings.

A large-scale review is needed to characterize the rates of airway, respiratory, and cardiovascular complications after pediatric tonsillectomy and adenoidectomy (T&A) for inpatient and ambulatory cohorts. To identify risk factors for postoperative complications stratified by age and operative facility type among children undergoing T&A. This retrospective review included 115,214 children undergoing T&A in hospitals, hospital-based facilities (HBF), and free-standing facilities (FSF) in California from January 1, 2005, to December 31, 2010. The analysis used the State of California Office of Statewide Health Planning and Development private inpatient data and Emergency Department and Ambulatory Surgery public data. Inpatient (n = 18,622) and ambulatory (n = 96,592) cohorts were identified by codes from the International Classification of Diseases, Ninth Revision, and Current Procedural Terminology. Data were collected from September 2011 to March 2012 and analyzed from March through May 2012. Rates of airway, respiratory, and cardiovascular complications. A total of 18,622 inpatients (51% male; 49% female; mean age, 5.4 [range, 0-17] years) and 96,592 ambulatory patients (37% male; 35% female; 28%, masked; mean age, 7.6 [range, 0-17] years) underwent analysis. The ratio of ambulatory to inpatient procedures was 5:1. Inpatients demonstrated more comorbidities (≤8, compared with ≤4 for HBF and ≤3 for FSF patients) and, in general, their complication rates were 2 to 5 times higher (seen in 1% to 12% of patients) than those in HBFs (0.2% to 5%), and more than 10 times higher than those in the FSFs (0% to 0.38%), with rates varying markedly by age range and facility type. Tonsillectomy and adenoidectomy was associated with increased risk for all complication types in both settings, reaching an odds ratio of 8.5 (95% CI, 6.6-11.1) for respiratory complications in the ambulatory setting. Inpatients aged 0 to 9 years experienced higher rates of airway and respiratory complications, peaking at an odds ratio of 7.5 (95% CI, 3.1-18.2) for airway complications in the group aged 0 to 11 months. Large numbers of pediatric patients undergo T&A in ambulatory settings despite higher rates of complications in younger patients and patients with more comorbidities. Fortunately, a high percentage of these patients has been appropriately triaged to the inpatient setting. Further research is needed to elucidate the subgroups that warrant postoperative hospitalization.

Prognostic Value of Galectin-3 for Adverse Outcomes in Chronic Heart Failure

BackgroundClinical studies have suggested the prognostic value of galectin-3, a marker of fibrosis, in chronic heart failure. However, the specific role of galectin-3, compared with established biomarkers, remains uncertain. Methods and ResultsThe Penn Heart Failure Study was an ambulatory heart failure cohort that included 1385 participants with reduced (1141), preserved (106), and recovered (138) left ventricular ejection fraction (LVEF). Cox regression models determined the association between galectin-3 and risk of all-cause mortality, cardiac transplantation, or placement of a ventricular assist device. Receiver operating characteristic curves compared the prognostic accuracy of galectin-3, high-sensitivity soluble Toll-like receptor 2 (ST2), troponin I, and B-type natriuretic peptide (BNP) at 1 and 5 years. Higher galectin-3 levels were associated with an increased risk of adverse events (adjusted hazard ratio of 1.96 for each doubling in galectin-3; P < .001). This association was most pronounced among participants with preserved LVEF (adjusted hazard ratio 3.30; P < .001). At 5 years, galectin-3 was the most accurate discriminator of risk among participants with preserved LVEF (area under the curve 0.782; P = .81 vs high-sensitivity ST2; P = .029 vs troponin I; P = .35 vs BNP). BNP was most accurate among participants with reduced and recovered LVEF (areas under the curves 0.716 and 0.728, respectively). ConclusionsGalectin-3 could have prognostic value for long-term events among patients with heart failure and preserved ejection fraction.

Abstract 14594: Gender Differences in Use of Anti-Coagulant For Atrial Fibrillation: A Report From the NCDR®

Background: Women with atrial fibrillation (AF) have a higher risk of thromboembolism compared to men. In contemporary practice, whether rates of anticoagulation use according to thromboembolic risk vary by gender and if this relationship has changed over time with introduction of expanded treatment options (novel oral anticoagulants [NOACs]) are unknown. Methods: Using the outpatient National Cardiovascular Data Registry (NCDR) PINNACLE registry from 2010-2014, oral anticoagulation (OAC- warfarin or novel anticoagulant) use was compared in women and men with non-valvular AF and CHA2DS2-VASc scores ≥ 2. Patients with documented contraindications to anticoagulation were excluded. Multivariable logistic regression models assessed the association between gender and OAC use (at each CHA2DS2-VASc level) adjusted for demographic and clinical factors, and accounting for clustering by practice using generalized estimating equations. Temporal trends in OAC use were also compared. Results: Of the 658,341 patients with non-valvular AF and CHADS2VASc ≥2, 45.2% were women. The average CHADS2VASc score for women and men was similar (mean±SD, 3.4±1.16 vs 3.4 ±1.19, respectively, p = 0.245). At all thromboembolic risk levels women were less likely than men to have any anticoagulant prescribed (e.g. at CHA2DS2-VASc score = 4 53.4% of women vs. 56.1% of men received OAC), in adjusted analysis, RR 0.95, 95% CI 0.94-0.96, p &lt;0.001(FIGURE). In temporal analysis, use of OAC increased over time in women and men (p &lt; 0.001 for trend) with increased NOAC use in both genders (p &lt;0.001 for trend). Conclusions: In this contemporary, ambulatory cohort of patients with non-valvular AF, women were slightly less likely to receive OAC across the spectrum of thromboembolic risk. Further studies are needed to understand the causes of these differences such as under-appreciation of gender as a risk factor or unequal treatment based on gender alone.

Serum Sodium Levels and Patient Outcomes in an Ambulatory Clinic-Based Chronic Kidney Disease Cohort

Background: Chronic kidney disease (CKD) patients are prone to both hypo- and hypernatremia. Little has been published on the epidemiology of hypo- and hypernatremia in ambulatory patients with non-dialysis CKD. Methods: Data collected in two contemporaneous CKD cohort studies, the Renal Research Institute (RRI)-CKD study (n = 834) and the Study of Treatment of Renal Insufficiency: Data and Evaluation (STRIDE) (n = 1,348) were combined and analyzed to study the association between serum sodium (Na⁺) and clinical outcomes. Results: Baseline estimated glomerular filtration rate (eGFR) and Na⁺ were 26 ± 11 ml/min/1.73 m² and 140.2 ± 3.4 mEq/l, respectively. The prevalence of Na⁺ ≤135 mEq/l and ≥144 mEq/l was 6 and 16%, respectively. Higher baseline Na⁺ was significantly associated with male sex, older age, systolic blood pressure, BMI, serum albumin, presence of heart failure, and lower eGFR. The risk of end-stage renal disease (ESRD) was marginally significantly higher among patients with Na⁺ ≤135 mEq/l, compared with 140< Na⁺ <144 mEq/l (referent), in time-dependent models (adjusted hazard ratio, HR = 1.52, p = 0.06). Mortality risk was significantly greater at 135< Na⁺ ≤140 mEq/l (adjusted HR = 1.68, p = 0.02) and Na⁺ ≥144 mEq/l (adjusted HR = 2.01, p = 0.01). Conclusion: CKD patients with Na⁺ ≤135 mEq/l were at a higher risk for progression to ESRD, whereas both lower and higher Na⁺ levels were associated with a higher risk of mortality. While caring for CKD patients, greater attention to serum sodium levels by clinicians is warranted and could potentially help improve patient outcomes.

Ambulatory Surgical Management of Obstructive Sleep Apnea: Is It Safe?

Objectives: Determine the safety of ambulatory oropharyngeal surgery in adults with obstructive sleep apnea. Methods: Retrospective cohort study. Relevant data were collected from patients aged 18+ years with obstructive sleep apnea (OSA) receiving head and neck airway surgery between September 1, 2005, and September 15, 2012. Results: Out of 315 patients with complete data, 243 (77.14%) were managed as inpatients and 72 (22.86%) in an ambulatory manner. The mean Apnea/Hypopnea Index (AHI) for the inpatient and ambulatory groups were 35.99 and 18.43, respectively ( P &lt; .00). The mean body mass index (BMI) for the inpatient and ambulatory groups was 34.12 and 30.79, respectively ( P &lt; .0002). When calculating the incident risk ratio of changes in AHI or BMI, AHI exhibited a significantly increased contribution. There were no complications in the ambulatory cohort. Conclusions: When evaluating body habitus and polysomnographic data, OSA patients who underwent oropharyngeal procedures and were discharged on the same day were significantly different than those who were admitted to the hospital. It appears from this data that patients with mild-moderate sleep apnea, even for patients with mild obesity, are safe to have these procedures performed in an ambulatory setting. This data could potentially assist practitioners in determining which procedures could be safely planned for an ambulatory setting and therefore decrease health care expenditures and patient inconvenience while maintaining patient safety. Future studies investigating what, if any, inpatient interventions were provided for those patients that were admitted to the hospital could potentially further expand the group of patient who could be safely managed in an ambulatory setting.

Abstract 226: Adherence to Aspirin Therapy for Primary Prevention of Coronary Artery Disease and Cerebrovascular Accidents

Cardiovascular disease is the leading cause of death in the United States. One simple, overlooked, and easily available therapy can reduce this risk: aspirin. Low dose aspirin reduces the risk of first time myocardial infarction (MI) in men and ischemic stroke (CVA) in women. The American Heart Association recommends anti-platelet therapy for those with an ASCVD (atherosclerotic cardiovascular disease) risk score&gt; 7.5%. The aim of our study was to determine adherence to guidelines regarding aspirin therapy for primary prevention of myocardial infarction and stroke in our resident clinic. A retrospective chart review of randomized patients with risk factors for CAD and CVA seen at Ambulatory Center in Newark, NJ, between 5/1/12 and 10/29/13 was conducted. Those with contraindications to aspirin therapy were excluded. Over 400 charts were reviewed; 281 met inclusion criteria. Per chart review, only 30% (84/281) of all at-risk patients were taking aspirin. When assessing various risk factors, 44.9% (35/78) of males ages 45-79; 24% (28/116) of females ages 55-79 (95% Confidence Interval [CI] = +-5.9%); 35.7% (51/143) of those with 10-year ASCVD risk score greater than 7.5% (95% CI = +-7.9%); 36.1% (39/108) of diabetic patients (95% CI 95% = +-9.2%); 32.8% (66/201) of those on anti-hypertensive medication (95% CI = +- 6.5%) and 29.3% (36/123) of those with a smoking history were taking aspirin (95% CI = +-8.2%). Of note, the number of women taking aspirin was statistically low as compared to men across all risk factors except for ASCVD score (p&lt;0.01). This study revealed poor adherence to guidelines with regards to use of aspirin for primary prevention of cardiovascular disease and stroke in our resident clinic. In particular, adherence to aspirin therapy for women was strikingly low. However, our estimate may be somewhat low due to improper documentation of over the counter medications. We are implementing interventions to increase awareness of aspirin use such as educational campaigns for patients, mini-lectures for ambulatory resident cohorts, automated EMR reminders and adding aspirin therapy to health maintenance smart texts to achieve our goal of 100% compliance.

Prospective validation study of the International Classification of Functioning, Disability and Health score in Crohn's disease and ulcerative colitis

Background and aimsInflammatory bowel diseases (IBD) may result in disability. We aim to validate a novel scoring system for the IBD disability index (IBD-DI), and identify predictors of disability and its correlation with work absenteeism. MethodsThis prospective IBD ambulatory clinic cohort study measured IBD-DI, Crohn's Disease Activity Index (CDAI) for Crohn's disease (CD) or partial Mayo score (pMayo) for ulcerative colitis (UC), IBDQ quality-of-life, and Work Productivity and Activity Impairment. Negative IBD-DI represented greater disability. Validation tests were performed and predictors and extent of work absenteeism were determined. Results166 consecutive subjects were recruited (75 CD, 41 UC, 50 controls). IBD-DI correlated with CDAI (r=−0.77, P<0.001), pMayo (r=−0.82, P<0.001) and IBDQ (r=0.86, P<0.001). IBD-DI differentiated CD, and UC from controls (medians −7, −4, +10; P<0.001) with a score of >3.5 identifying controls with 94% sensitivity and 83% specificity (area-under-curve 0.92). Stable patients had unchanged IBD-DI (P=ns) but not in those who relapsed (P<0.001). Intraclass correlation was 0.89 and Cronbach's alpha of internal consistency was 0.94. Diagnosis age, sex, phenotype, perianal disease, prior surgery, steroid-use and disease duration did not influence the IBD-DI but active use of biological agents significantly reduced disability (P=0.03). 21.6% of IBD patients had moderate-severe disability equating to missing >25% of work hours in the previous week. Multivariate analysis identified that only IBD-DI to be predictive of unemployment status (OR: 0.94; 95% CI: 0.89–0.99). ConclusionsThe IBD-DI is a valid tool measuring disability in both CD and UC and correlates with workforce participation. It is a potential useful tool in the assessment of participation restriction and activity limitation. Trial registration: ACTRN12613000903785.

Glucocorticoids predict 10-year fragility fracture risk in a population-based ambulatory cohort of men and women: Canadian Multicentre Osteoporosis Study (CaMos)

We determined the prospective 10-year association among incident fragility fractures and four glucocorticoid (GC) treatment groups (Never GC, Prior GC, Baseline GC, and Ever GC). Results showed that GC treatment is associated with increased 10-year incident fracture risk in ambulatory men and women across Canada. Using the Canadian Multicentre Osteoporosis Study dataset, we determined the prospective 10-year association between incident fragility fractures and GC treatment. We conducted a 10-year prospective observational cohort study at nine sites across Canada. A total of 9,263 ambulatory men and women 25 years of age and older were included in the analysis. Multivariable Cox proportional hazards analyses were conducted to determine the relationship among GC treatment groups in four levels that included Never GC, Prior GC, Baseline GC, and Ever GC (combined baseline and prior groups) and time to fracture. In each of the Never GC, Prior GC, Baseline GC, and Ever GC treatment groups, the number of participants were 8,832 (95.4 %), 303 (3.3 %), 128 (1.4 %), and 431 (4.7 %), respectively. Of the 9,263 individuals enrolled, incident fragility non-spine, hip, spine, and any fractures were experienced by a total of 896 (9.67 %), 157 (1.69 %), 130 (1.40 %), and 1,102 (11.90 %) over 10-years, respectively. For men and women combined, prior GC treatment was associated with a higher hazard ratio (HR) for time to incident non-vertebral (HR = 1.5, 95 % confidence interval [CI] = 1.1, 2.0), hip (HR = 2.1, 95 % CI = 1.1, 4.0), and any fracture (HR = 1.4, 95 % CI = 1.0, 1.8) compared with never GC treatment. GC treatment is associated with increased 10-year incident fracture risk; this highlights the importance of considering therapy to prevent GC-induced fractures for patients who are using GC for various medical conditions.

Circulation : Clinical Summaries

<i>Circulation</i> : Clinical Summaries

759Patient-Captured Digital Images to Assess Post-operative Wounds for Infection: a pediatric ambulatory surgery cohort study

759Patient-Captured Digital Images to Assess Post-operative Wounds for Infection: a pediatric ambulatory surgery cohort study

PEG-J Administration of Therapeutic Agents for Neurological Disorders: Levodopa-Carbidopa Intestinal Gel for Advanced Parkinsonʼs Disease

Purpose: To determine whether PEG-J administration of levodopa-carbidopa intestinal gel (LCIG) is an effective method for the treatment of advanced Parkinson's disease (PD). Methods: Levodopa is the most effective treatment for PD. With advanced disease, irregular gastric emptying impedes standard oral levodopa effectiveness leading to “On”/”Off” motor fluctuations and dyskinesias. Two phase 3 clinical studies enrolled advanced PD patients with persistent motor fluctuations despite optimized oral therapy. For this novel treatment, involving the collaboration of neurologists and gastroenterologists, all patients underwent a PEG-J procedure for infusion of LCIG (or placebo gel) directly to the proximal jejunum. A 12-week, randomized, double-blind, double-dummy trial compared the effectiveness of LCIG with standard oral levodopa (LC-oral) at reducing motor fluctuations and improving quality of life. A 54-week open-label international trial examined the long-term safety and efficacy of LCIG. “Off” time (when medication is no longer effective and motor symptoms return), the Unified Parkinson's Disease Rating Scale (UPDRS) and the 39-item Parkinson's Disease Questionnaire (PDQ-39) were examined. Adverse events (AEs) were recorded. Results: 71 patients were enrolled in the double-blind, double-dummy trial (n=37 LCIG, 34 LC-Oral), with a mean PD duration of 10.9 years. The reduction in “off” time (P<0.01), improvement in UPDRS Part II (activities of daily living) score (P<0.01) and improvement in PDQ-39 Summary Index (P<0.05) was greater in the LCIG group than in the LC-oral group. Three hundred fifty four patients were enrolled in the long-term, open-label study. As with the double-blind trial, “off” time, UPDRS Part II score and PDQ-39 Summary Index versus baseline were improved at all visits (through Week 54; P<0.01). Most patients (97% in double-blind, 91% in open-label) experienced at least 1 AE; serious AEs occurred in 17% (double-blind) and 31% (open-label). AEs led to discontinuation in 4.2% (double-blind) and 7.6% (open-label). Most AEs were known AEs associated with either levodopa, underlying PD or the procedure and the device. Conclusion: Intrajejunal infusion of LCIG via PEG-J is a novel approach for the long-term delivery of medication in gel form, which improved motor fluctuations and the quality of life in advanced PD patients with limited treatment options. The range of PEG-J complications was within standard ranges reported in the literature and was not increased in this ambulatory patient cohort. Disclosure - Michael Epstein: Dr. Epstein served on the data adjudication panel for this study and has received compensation from AbbVie for serving as a consultant. Dr. Epstein also serves as a lecturer for AbbVie. David Johnson: Dr. Johnson served on the data adjudication panel for this study and has received compensation from AbbVie for serving as a consultant. Robert Hawes: Dr. Hawes served on the data adjudication panel for this study and has received compensation from AbbVie for serving as a consultant. Nathan Schmulewitz: Dr. Schmulewitz serves as a medical advisor and speaker for AbbVie. Arvydas Vanagunas: Dr. Vanagunas has received compensation from AbbVie and CVS Caremark's Pharmacy & Therapeutics Committee for serving as a consultant and has been a scientific advisory board member for AbbVie. Cindy Zadikoff: CZ was a study investigator and has received compensation from AbbVie for serving as a consultant and participating in scientific advisory boards. Rod Gossen: served as executive secretary for this study and is employed by a consulting agency under contract with AbbVie. Susan Eaton, Krai Chatamra, Weining Robieson, Jordan Dubow and Janet Benesh are employees of AbbVie and hold AbbVie stock and/or stock options. AbbVie participated in the study design, research, data collection, analysis and interpretation of data, writing, reviewing, and approving the publication. Michelle M. Koutsantonis, of AbbVie, provided medical writing assistance in the development of this publication. This research was supported by an industry grant from AbbVie.

Advanced Disease, Diuretic Use, and Marital Status Predict Hospital Admissions in an Ambulatory Cirrhosis Cohort

Hospital admissions in cirrhotic patients are a source of significant health care expenditure. Most studies to date have focused on readmissions in patients with decompensated cirrhosis. We sought to describe predictors of hospital admissions in an ambulatory cirrhosis cohort consisting of both compensated and decompensated patients to identify patients who could benefit from intensified outpatient chronic disease management. We performed a retrospective cohort study of 395 cirrhotic patients followed at an academic medical center liver clinic. Inclusion criteria were documented cirrhosis and longitudinal care at our center during 2006-2008. Patients were followed until December 2011, death, or liver transplantation. The primary outcomes were non-elective cirrhosis-related hospital admissions within 1 year and time to admission. The secondary outcome was 2-year cirrhosis-related mortality. The study was approved by the Partners Human Research Committee (protocol 2012P001912). Seventy-eight patients (19.7 %) had at least one cirrhosis-related hospital admission within 1 year. The following were significant predictors in the multivariable model: model for end-stage liver disease score ≥15 [OR 2.22, 95 % CI (1.21-4.07), p = 0.01], diagnosis of hepatocellular carcinoma [3.64 (1.42-9.35), 0.007], diuretic use [2.27 (1.23-4.17), 0.008], at least one cirrhosis-related admission during the baseline year [2.17 (1.21-3.89), 0.01], and being unmarried [1.92 (1.10-3.35), 0.02]. Advanced disease, diuretic use, and marital status were associated with cirrhosis-related hospital admissions in patients followed at an academic medical center liver clinic. Our findings suggest that patients with inadequately or overzealously treated ascites, as well as those with limited social supports, could benefit from intensified outpatient management.

Coste-efectividad del proceso hallux valgus en cirugía mayor ambulatoria

IntroductionThe development of one-day surgery units has shown to be a better use of health resources without reducing quality. The objective of this study was to evaluate the effectiveness and quality criteria of ambulatory surgery program in the Hallux valgus process. Material and methodsA retrospective study was conducted on a sample of 753 patients who underwent a Hallux valgus process at our institution between 2002 and 2012 (292 in ambulatory surgery cohort and 461 in hospitalization group). The cost-process was evaluated using the Weighted Care Unitas a measuring unit. Secondary data were collected as regards discharge criteria and patient satisfaction. ResultsA significant difference was found between Weighted Care Unit spending on in-patient surgery and out-patient surgery. Both samples were comparable and no differences were found between diagnosis and intervention. The admission rate after ambulatory surgery was 2.39%, and the substitution index increased to 56.04%. The ambulatory surgery program was given a satisfaction rating of 84.6 out of 100. ConclusionsThe results of our study indicate that it is possible to maximize the substitution index of the Hallux valgus process leading to a better use of resources and a high degree of patient satisfaction.

Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010

Non-fatal health outcomes from diseases and injuries are a crucial consideration in the promotion and monitoring of individual and population health. The Global Burden of Disease (GBD) studies done in 1990 and 2000 have been the only studies to quantify non-fatal health outcomes across an exhaustive set of disorders at the global and regional level. Neither effort quantified uncertainty in prevalence or years lived with disability (YLDs).Of the 291 diseases and injuries in the GBD cause list, 289 cause disability. For 1160 sequelae of the 289 diseases and injuries, we undertook a systematic analysis of prevalence, incidence, remission, duration, and excess mortality. Sources included published studies, case notification, population-based cancer registries, other disease registries, antenatal clinic serosurveillance, hospital discharge data, ambulatory care data, household surveys, other surveys, and cohort studies. For most sequelae, we used a Bayesian meta-regression method, DisMod-MR, designed to address key limitations in descriptive epidemiological data, including missing data, inconsistency, and large methodological variation between data sources. For some disorders, we used natural history models, geospatial models, back-calculation models (models calculating incidence from population mortality rates and case fatality), or registration completeness models (models adjusting for incomplete registration with health-system access and other covariates). Disability weights for 220 unique health states were used to capture the severity of health loss. YLDs by cause at age, sex, country, and year levels were adjusted for comorbidity with simulation methods. We included uncertainty estimates at all stages of the analysis.Global prevalence for all ages combined in 2010 across the 1160 sequelae ranged from fewer than one case per 1 million people to 350,000 cases per 1 million people. Prevalence and severity of health loss were weakly correlated (correlation coefficient -0·37). In 2010, there were 777 million YLDs from all causes, up from 583 million in 1990. The main contributors to global YLDs were mental and behavioural disorders, musculoskeletal disorders, and diabetes or endocrine diseases. The leading specific causes of YLDs were much the same in 2010 as they were in 1990: low back pain, major depressive disorder, iron-deficiency anaemia, neck pain, chronic obstructive pulmonary disease, anxiety disorders, migraine, diabetes, and falls. Age-specific prevalence of YLDs increased with age in all regions and has decreased slightly from 1990 to 2010. Regional patterns of the leading causes of YLDs were more similar compared with years of life lost due to premature mortality. Neglected tropical diseases, HIV/AIDS, tuberculosis, malaria, and anaemia were important causes of YLDs in sub-Saharan Africa.Rates of YLDs per 100,000 people have remained largely constant over time but rise steadily with age. Population growth and ageing have increased YLD numbers and crude rates over the past two decades. Prevalences of the most common causes of YLDs, such as mental and behavioural disorders and musculoskeletal disorders, have not decreased. Health systems will need to address the needs of the rising numbers of individuals with a range of disorders that largely cause disability but not mortality. Quantification of the burden of non-fatal health outcomes will be crucial to understand how well health systems are responding to these challenges. Effective and affordable strategies to deal with this rising burden are an urgent priority for health systems in most parts of the world.Bill & Melinda Gates Foundation.

Abstract 18578: Replication of a Risk Prediction Model for Ambulatory Incident Atrial Fibrillation Using Electronic Medical Record

Introduction: Atrial fibrillation (AF) contributes to substantial increases in morbidity, mortality and increasing healthcare expenditures. Using data from community-based cohorts, CHARGE-AF investigators developed an AF risk prediction model. We aimed to replicate the CHARGE AF risk model using the Vanderbilt electronic medical records (EMR) repository. Methods: We identified a large ambulatory cohort of Caucasians and African Americans of age ≥ 40 years without a prior history of AF, followed by assessment of incident AF over a 5-year period (December 2005 to December 2010) using prospective chart review and validated AF algorithm. Baseline clinical variables (age, ethnicity, sex, height, weight, systolic and diastolic BP, PR interval, current use of antihypertensive medications, DM, MI, CHF, current smoking, and LVH on ECG) were extracted on or within 6 months prior to December 2005. We used multiple imputation for missing values and multivariable Cox proportional hazards analysis to construct our risk prediction model. Results: Our study cohort consisted of 63,772 subjects (age 58±11 years, 47% male, 90% Caucasians) with no prior history of AF. Over a mean follow up time of 3.9±0.95 years, 3,383 (5.3%) subjects developed AF in 2.6±1.3 years. In the multivariable model, older age, Caucasian ethnicity, male sex, taller height, greater weight, history of heart failure, LVH on ECG and prolonged PR interval were all significant risk predictors of AF (similar to CHARGE-AF risk model), whereas current use of antihypertensive medication was protective of developing AF (Table). The C-index from our model, 0.768, indicated relatively good discrimination. Conclusions: From clinical factors readily accessible in a large de-identified EMR database, we replicated the CHARGE AF risk prediction model to identify individuals at risk for developing AF in an ambulatory setting. This risk model may be used to target high risk-individuals for preventive measures.