Validation of clinical risk score for colorectal liver metastases resected in a contemporary multicenter cohort

Background

Recent advances in care for colorectal liver metastases (CRLM) have lengthened 5-year survival. In this new era, prognostic tools such as the clinical risk score (CRS) for colorectal liver metastases require reevaluation.

Vascular complications in systemic sclerosis: a prospective cohort study

Clinical Rheumatology - Two major complications in scleroderma patients that cause substantial morbidity and mortality are ischemic digital lesions (DL) and pulmonary hypertension (PH). The...     

Gender-specific risk factors for incident gout: a prospective cohort study

Previous reports suggested that gout incidence increased with serum uric acid (sUA) level. In addition to sUA, we aimed to examine the gender-specific risk factors for incident gout. A prospective study was conducted using data of the MJ Health Screening Center and outcome database from Taiwan’s National Health Insurance. Cox proportional hazard model was used for risk analysis of incident gout. During a mean follow-up of 7.31 years for 132,556 individuals aged ≥18 years, 1,606 subjects (1,341 men and 265 women) with clinical gout were defined. Hyperuricemia (sUA ≥7.7 mg/dL for men or ≥6.6 mg/dL for women) was the most important risk factor for gout development with a respective hazard ratio of 9.65 (95% confidence level, 8.53–10.9) for men and 9.28 (7.00–12.3) for women. The age-standardized sUA–gout relationship demonstrated a differential impact of sUA level on gout incidence between men and women. Metabolic comorbidities of hypertension, obesity, and hyperlipidemia were significantly associated with gout with respective HR of 1.32 (1.17–1.48), 1.30 (1.15–1.47), and 1.12 (0.99–1.26) for men and 1.34 (1.02–1.77), 2.15 (1.67–2.76), and 1.70 (1.32–2.19) for women. However, the relationship between diabetes and incident gout was not as prominent. The sex difference of sUA–gout relationship and the association between metabolic comorbidities and incident gout were demonstrated. Generalizability of these findings to other ethnic population needs further investigation.     

The DGAV risk calculator: development and validation of statistical models for a web-based instrument predicting complications of colorectal cancer surgery

Purpose

The purpose of this study is to provide a web-based calculator predicting complication probabilities of patients undergoing colorectal cancer (CRC) surgery in Germany.

Methods

Analyses were based on records of first-time CRC surgery between 2010 and February 2017, documented in the database of the Study, Documentation, and Quality Center (StuDoQ) of the Deutsche Gesellschaft für Allgemein- und Viszeralchirurgie (DGAV), a registry of CRC surgery in hospitals throughout Germany, covering demography, medical history, tumor features, comorbidity, behavioral risk factors, surgical procedures, and outcomes. Using logistic ridge regression, separate models were developed in learning samples of 6729 colon and 4381 rectum cancer patients and evaluated in validation samples of sizes 2407 and 1287. Discrimination was assessed using c statistics. Calibration was examined graphically by plotting observed versus predicted complication probabilities and numerically using Brier scores.

Results

We report validation results regarding 15 outcomes such as any major complication, surgical site infection, anastomotic leakage, bladder voiding disturbance after rectal surgery, abdominal wall dehiscence, various internistic complications, 30-day readmission, 30-day reoperation rate, and 30-day mortality. When applied to the validation samples, c statistics ranged between 0.60 for anastomosis leakage and 0.85 for mortality after rectum cancer surgery. Brier scores ranged from 0.003 to 0.127.

Conclusions

While most models showed satisfactory discrimination and calibration, this does not preclude overly optimistic or pessimistic individual predictions. To avoid misinterpretation, one has to understand the basic principles of risk calculation and risk communication. An e-learning tool outlining the appropriate use of the risk calculator is provided.

     

Atrial fibrillation and risk of dementia: a prospective cohort study

OBJECTIVES: To determine whether atrial fibrillation (AF) is associated with risk of incident dementia or Alzheimer's disease (AD), beyond its effect on stroke. DESIGN: Prospective cohort study. SETTING: An integrated healthcare delivery system. PARTICIPANTS: A population‐based sample of 3,045 community‐dwelling adults aged 65 and older without dementia or clinical stroke followed from 1994 to 2008. MEASUREMENTS: AF was identified from health plan electronic data using International Classification of Diseases, Ninth Revision, codes from inpatient and outpatient encounters. Covariates came from self‐report, study measures, and health plan data. Participants were screened every 2 years using the Cognitive Abilities Screening Instrument (range 0–100), with detailed neuropsychological and clinical assessment of those scoring less than 86. A multidisciplinary consensus committee determined diagnoses of all‐cause dementia and possible or probable AD using standard research criteria. RESULTS: AF was present in 132 (4.3%) participants at baseline and was diagnosed in 370 (12.2%) more over a mean of 6.8 years of follow‐up; 572 participants (18.8%) developed dementia (449 with AD). The adjusted hazard ratio associated with AF was 1.38 (95% confidence interval (CI)=1.10–1.73) for all‐cause dementia and 1.50 (95% CI=1.16–1.94) for possible or probable AD. Results were similar for participants with and without clinically recognized stroke during follow‐up and in sensitivity analyses examining only probable AD. CONCLUSION: AF is associated with higher risk of developing AD and dementia. Future studies should examine whether specific treatments, including optimal anticoagulation, can decrease this risk.     

COMBAT--conventional versus multisite pacing for bradyarrhythmia therapy: rationale of a prospective randomized multicenter study

COMBAT is a prospective, multicenter, randomized, blinded clinical study, with crossover design. The main objective is the comparative evaluation of atrio-biventricular versus conventional atrioventricular stimulation (atrio and right ventricle) in patients with heart failure and bradycardia as the primary indication for pacemaker implantation. After successful atrio-biventricular system implantation, patients will be randomized into two groups: group A--atrioventricular conventional pacing and group B--atrio-biventricular pacing. Both groups will be programmed in DDD mode with AV delay optimized by echocardiogram. After 3 months, New York Heart Association functional class, ventricular arrhythmia density and complexity, echocardiography outcomes, 6-min hall walk distance, quality of life and peak oxygen consumption will be assessed in all patients. Then, all patients will crossover to the other pacing regimen, with an additional AV delay adjustment by echo. Patients will be followed up for another 3 months at the end of which all evaluations will be repeated. Patients will then crossover back to their original pacing regimen for a further 3 months. At the end of this 9-month period, patients will be reprogrammed according to their optimal pacing regime. In an extended follow-up, patient survival will be evaluated after 24 months of the optimal pacing therapy.     

Treatment of patients with achalasia with botulinum toxin: a multicenter prospective cohort study

Botulinum toxin (BT) injection is an alternative treatment of achalasia. The aim of the study was to examine outcomes of patients treated with BT in the Czech Republic. Since 1997, 49 patients with achalasia have been treated with BT. We prospectively evaluated the effect of BT injection on 41 patients during a median follow-up of 24 months (range 9-62). Esophageal manometry was performed before and at 3-5 months after the injection. In 16 patients, BT was injected from the antegrade angle only (subgroup A), in 15 patients, BT was injected from both retrograde and antegrade angles (subgroup B) and, in 10 patients, BT injection was combined with subsequent balloon dilatation (subgroup C). Immediate clinical response was achieved in 93% of patients. Clinical remission was sustained beyond 3 months in 83% of patients (responders). Fourteen responders (41%) did not experience a relapse during the median of 22 months. Twenty responders (59%) experienced symptomatic relapse approximately 8 months after the injection. Ten relapsers underwent BT reinjection, five (50%) of them were asymptomatic for another 14 months. The remaining five (50%) patients reported a second relapse approximately 6 months after the reinjection. Median duration of the symptom-free period was 11.5 months after the first BT injection, and 10.5 months after the second (P = 0.21). We did not find any significant predictor of a favorable outcome; responders tended to be older and to have a lower basal lower-esophageal-sphincter pressure. Patients in subgroup C were more likely to be in remission at 1 and 2 years as compared with patients in subgroup A. BT injection is an effective treatment of achalasia in the short term. However, almost 70% of patients experience a relapse within 2 years. BT injection should therefore be reserved for patients at risk for more invasive procedures or for patients who prefer this treatment.     

Bedside quantification of atherosclerosis severity for cardiovascular risk stratification: a prospective cohort study

OBJECTIVES: We sought to assess the ability of a new noninvasive method to quantify atherosclerosis severity and to examine its power to predict cardiovascular events. BACKGROUND: Drug prevention of cardiovascular events is effective but costly, leading to a debate about who should receive this treatment. Patient selection is often based on surrogate markers, but quantification of atherosclerosis severity is desirable. METHODS: Atherosclerosis severity was quantified by determination of specific aortic wall elastance in transthoracic echocardiography, applying the biomechanics of pulse wave propagation. After validating the method in 52 patients by measuring aortic plaque burden in transesophageal echo directly, another 336 patients were prospectively studied by monitoring atherosclerotic events at one year and comparing the results with conventional risk stratification. RESULTS: Specific aortic elastance was well correlated with plaque burden (p < 0.0001) and largely independent of confounding variables. Specific aortic elastance predicted the primary end point of "atherosclerotic death, myocardial infarction or stroke" at one year (p < 0.0002). Event rate at one year in the lowest specific elastance tertile was 1.8% (CI 0.0% to 4.3%), in the middle tertile 5.4% (CI 1.1% to 9.7%) and in the highest tertile 12.7% (CI 6.3% to 19%). Secondary end points supported these findings. Stepwise multivariate analysis identified specific aortic elastance, prior atherosclerotic events and left ventricular ejection fraction as independent risk predictors. Specific elastance was of incremental value to clinically identified variables. CONCLUSIONS: Bedside measurement of specific aortic elastance allows assessment of atherosclerosis severity. It predicts the risk for future atherosclerotic events beyond conventional risk factors, promising better targeting of pharmacologic prevention and improved cost effectiveness.     

Enhanced recovery after surgery (ERAS®) protocol adapted to the Brazilian reality: a prospective cohort study for thoracic patients

BackgroundIn Low-Middle Income Countries (LMICs), resource optimization and infrastructure availability are recurrently in debate. In order to assist the development and implementation of guidelines, LMICs often exemplify from High-Income Countries protocols. At the final, it will be: content adaption is often needed. In this study, we demonstrated the preliminary analysis of the Brazilian experience by adapting the ERAS^® Protocol for thoracic surgery patients (PROSM).MethodsPatients’ data were extracted from the surgical group database that operated in the city of Sao Paulo. Patients’ data were organized for analysis after the institution’s ethics committee gave their approval. Patients’ variables were analyzed and compared to a control group. Subgroup analysis included patients without ICU Admission.ResultsPROSM patients had reduced ICU length of stay (LOS) (Mean of 0.3±0.58 days, 1.2±1.65 days, P=0.001), Hospital LOS (Mean of 1.6±1.32 days, 3.9±3.25 days, P=0.001) and Chest Drain duration (Median 1.0±1.00 days, 3.0±3.00 days, P=0.001). Analyses of patients that were not admitted to the ICU demonstrated reduced Hospital LOS and Chest drain duration. Cost analysis, such as procedure, daily, and post-surgical costs were also significantly lower towards PROSM group.ConclusionsThis study revealed important aspects for improvement of the delivered care quality and opportunity for expenditure management. We expect to assist more countries to improve knowledge under the implementation of enhanced protocols.