Real-World Safety and Efficacy of Fluid-Filled Dual Intragastric Balloon for Weight Loss.

BACKGROUND & AIMS: Reshape Duo is a saline-filled dual, integrated intragastric balloon (IGB) approved by the Food and Drug Administration for weight loss in patients with obesity. In a prospective, randomized trial, obese patients who received the balloon had significantly greater percent excess weight loss (%EWL) compared with patients treated with diet and exercise alone. However, there are limited data on the real-world efficacy of the Reshape balloon. METHODS: We performed a retrospective study of data collected from 2 academic centers and 5 private practices in which all patients paid for the IGB and follow-up visits out of pocket. The IGB was removed after 6 months. We collected data (demographic, medical, and laboratory) from 202 adults (mean age 47.8 ± 10.8 years; 83% female) with a baseline mean body mass index of 36.8 + 8.4 kg/m2 who had IGB insertion for weight loss therapy, along with counselling on lifestyle modifications focused on diet and exercise. Primary outcomes were percent total body weight loss (%TBWL) and %EWL at 1, 3, 6, 9, and 12 months after the procedure. RESULTS: Mean %TBWL at 1, 3, 6, 9 and 12 months was 4.8 ± 2.4%, 8.8 ± 4.3%, 11.4 ± 6.7%, 13.3 ± 7.8%, and 14.7 ± 11.8%, respectively. Data were available from 101 patients at 6 months and 12 patients at 12 months; 60.4% of patients achieved more than 10% TBWL and 55.4% had more than 25% EWL. Seventeen patients (8.4%) had esophageal tears during balloon insertion, with no intervention required. Thirteen patients (6.4%) had their IGB removed before the end of the 6-month treatment period. Nausea, vomiting, and abdominal pain were the most common adverse effects, occurring in 149 (73.8%), 99 (49%), and 51 (25.2%) patients. In one patient, the IGB migrated distally leading to small intestinal obstruction requiring surgical removal. CONCLUSION: In a retrospective analysis of real-world patients who received the Reshape Duo IGB, we found it to be a safe and efficacious endoscopic method for producing weight loss, with most patients achieving greater than 10% TBWL at 6 months.

Neutrophil-lymphocyte ratio as a predictor of adverse outcomes of acute pancreatitis.

BACKGROUND: Most acute pancreatitis risk scoring systems use total white blood cell counts (WBC) as one of the risk factors. The value of the neutrophil-lymphocyte ratio (NLR) to predict the severity of acute pancreatitis has not been previously evaluated. METHODS: This observational study included 283 patients admitted to a tertiary center between 2004 and 2007. The patients were arranged into tertiles according to NLR and WBC values. The primary outcomes were intensive care unit (ICU) admission and length of stay (LOS) in the hospital. RESULTS: According to NLR tertiles, patients in the 3rd tertile (NLR ≥7.6) had significantly more ICU admissions (17 vs. 2.2%, p < 0.0001) and longer average LOS (6.2 vs. 4.2 days, p < 0.002) compared with those in the 1st tertile (NLR <3.6). According to WBC tertiles, patients in the 3rd tertile had more ICU admissions (12.6 vs. 6.2%, p = 0.12) and a longer average LOS (5.8 vs. 4.4 days, p = 0.059) compared to patients in the 1st WBC tertile, but this did not reach statistical significance. In the multivariate model including NLR, WBC and other predictors, only NLR tertiles (p < 0.0262) and modified early warning scores (p < 0.0025) were significant predictors of ICU admission. Likewise, in the multivariate model of LOS, only NLR and glucose level were significant predictors of longer LOS (p < 0.0161 and p < 0.0053, respectively). CONCLUSION: NLR is superior to total WBC in predicting adverse outcomes of acute pancreatitis. According to our data, we suggest using the NLR cutoff value of >4.7 as a simple indicator of severity in patients presenting with acute pancreatitis. and IAP.

Post-resuscitation reperfusion injury: comparison of periodic Gz acceleration versus Thumper CPR.

The effects of whole body, periodic acceleration (pGz) on cardiopulmonary resuscitation outcome, organ blood flow and tissue inflammatory injury were examined in an experimental pig model, and compared with Thumper (TH)-CPR. VF was induced in 16 pigs, and remained untreated for 3 min, followed by either pGz-CPR or TH-CPR for 15 min. Defibrillation attempts were made at 18 min of VF. Six of eight animals had ROSC in both groups. Post-arrest myocardial dysfunction was present in both groups and progressed over hours. pGz-CPR animals had less wall motion abnormality and higher left ventricular ejection fraction than TH-CPR. The post-resuscitation haemodynamic variables returned to baseline after 3h of ROSC in pGz-CPR group, and remained low in TH-CPR group. The brain blood flow during CPR was similar between TH-CPR and pGz-CPR, 17% and 20% of pre-fibrillation values, respectively. The cardiac blood flow during CPR was significantly lower in pGz-CPR than TH-CPR (TH: 10.2% and pGz: 1.9% of pre-fibrillation value), as well as in other organs. The brain and heart blood flow was significantly higher than pre-fibrillation values after 30 min of ROSC in both groups. The pGz group had significantly higher blood flow in brain, heart and kidney than TH-CPR after 30 min of ROSC. Blood flow in all organs decreased below pre-fibrillation values at 2h of ROSC. Tissue inflammatory injury progressed over hours in the post-resuscitation phase. pGz-CPR group had significantly lower myeloperoxidase (MPO) activity and plasma creatine phosphokinase (CPK) and cardiac troponin I, TNF-alpha, and IL-6 than TH-CPR. Results from the present study demonstrate again that pGz-CPR is an effective method of cardiopulmonary resuscitation, with less post-reperfusion injury compared to TH-CPR.