Impact of Tocilizumab on Clinical Outcomes in COVID-19-Associated Cytokine Release Syndrome: A Single-Center Experience.

BACKGROUND: Tocilizumab is an interleukin-6 receptor antagonist hypothesized to blunt the uncontrolled immune response, cytokine release syndrome, in severe COVID-19 and prevent attributable morbidity and mortality. Objective: The objective of this study was to assess the impact of tocilizumab on clinical outcomes in COVID-19-associated cytokine release syndrome. METHODS: Single-center, retrospective cohort study assessing sixty-nine adult patients receiving tocilizumab for suspected COVID-19 cytokine release syndrome. The primary outcome was change in WHO clinical status scale on day seven post-dose analyzed using the Wilcoxon signed rank test. Secondary outcomes assessed impact of timing of administration on clinical outcome. Safety analyses included development of neutropenia, thrombocytopenia, transaminitis, and sepsis within 7 days post-dose. Statistical analyses were conducted using Microsoft Excel. RESULTS: No aggregate clinical change was found between day 0 and day 7. Eleven patients improved, twenty-seven worsened, and thirty-one showed no change. Clinical outcomes were weakly correlated with time from symptom onset (rs = 0.21; p = 0.08) or hospital admission (rs = -0.08; p = 0.49) to dose. In-hospital mortality was 63%. Sepsis was diagnosed in 21 patients, five of which were post-dose. Transaminitis, neutropenia, and thrombocytopenia occurred in seven, one, and six patients, respectively. CONCLUSION: Tocilizumab did not appear to influence clinical outcomes in our study population, irrespective of timing of administration. Adverse events were not considered drug-related.

Gastrointestinal symptom improvement after Roux-en-Y gastric bypass: long-term analysis.

BACKGROUND: Obese patients have a multitude of gastrointestinal symptoms that differ from their nonobese counterparts. The published data remain scant on changes in gastrointestinal symptoms among this cohort before and after Roux-en-Y gastric bypass (RYGB). The aim of this study was to quantify these symptoms and understand the changes that occur after bariatric surgery. METHODS: A total of 1724 gastrointestinal symptom surveys were prospectively administered to 763 consecutive patients who underwent laparoscopic RYGB. The patients rated each symptom on a 0-100-mm Liekert scale: 0, absence of symptoms; 33, occasional occurrence; 67, frequent occurrence; 100, continuous. The surveys were administered preoperatively and yearly thereafter. The data are presented as the mean + or - standard error of the mean. RESULTS: Of the 763 patients, 137 were black, 610 were white, and 16 were Hispanic; 83% were women and 17% were men. Their age was 40.8 + or - 0.34 years. The body mass index was 48.4 + or - 0.27 kg/m(2). The American Society of Anesthesiologists class was 2 for 31%, 3 for 68%, and 4 for 1%. Of the 763 patients, 63% underwent short-limb RYGB and 37% underwent long-limb RYGB. The preoperative symptom rating was as follows: abdominal pain, 24.3 + or - 0.7; heartburn, 41.0 + or - 0.8; acid regurgitation, 30.9 + or - 0.9; gnawing epigastric sensation, 26.5 + or - 0.9; nausea/vomiting, 18.8 + or - 0.7; borborygmus, 26.2 + or - 0.8; abdominal distension, 30.3 + or - 0.9; eructation, 28.0 + or - 0.8; increased flatus, 38.9 + or - 0.8; decreased passage of stool, 14.8 + or - 0.8; increased passage of stool, 16.4 + or - 0.7; loose stools, 22.1 + or - 0.8; hard stools, 20.5 + or - 0.9; urgent need for defecation, 23.2 + or - 0.8; incomplete evacuation, 22.2 + or - 0.8; difficulty falling asleep, 42.0 + or - 1.1; insomnia, 38.4 + or - 1; feeling rested, 60.1 + or - 1; and difficulty swallowing, 13.5 + or - 0.67. At 1, 2, 3, 4, and 5 years after RYGB, 99.5% 84.2%, 68.4%, 57.9% and 47.4% of these symptoms had improved significantly (P < .05). CONCLUSION: Laparoscopic RYGB significantly improves the gastrointestinal symptoms experienced by morbidly obese patients without adversely affecting any of the measured parameters. This improvement in symptoms proved durable in the long term.

Pharmacologic prophylaxis against venous thromboembolic complications is not mandatory for all laparoscopic Roux-en-Y gastric bypass procedures.

BACKGROUND: Venous thromboembolism (VTE) is a leading cause of postoperative mortality in bariatric surgical patients. The aim of this study is to report the rate of VTE and bleeding complications using no prophylactic pharmacologic anticoagulation among patients undergoing laparoscopic Roux-en-Y gastric bypass. STUDY DESIGN: Nine hundred fifty-seven consecutive patients who were older than 18 years, had no history of VTE, and had laparoscopic Roux-en-Y gastric bypass by a single surgeon (RHC) between January 2000 and October 2008 were included. Outcomes, including deep vein thrombosis and pulmonary embolism, were prospectively collected and retrospectively analyzed using SAS (version 9.1, SAS Institute Inc). VTE prophylactic regimen consisted of calf-length pneumatic compression devices placed before anesthesia induction and mandatory ambulation beginning on the day of operation. No prophylactic pharmacologic anticoagulation was used. All data presented as mean +/- SEM. RESULTS: Of the 957 patients, 792 were women and 165 were men. Mean age was 41.0 +/- 0.3 years, body mass index (calculated as kg/m(2)) was 49.1 +/- 0.2, and American Society of Anesthesiology scores 2 (29.8%), 3 (69.8%), and 4 (0.4%). Mean operative time was 106.0 +/- 0.8 minutes. Clinically evident deep vein thrombosis developed in three patients (0.31%) and one patient had a pulmonary embolism (0.10%). The one mortality in the cohort was unrelated to VTE. There were seven (0.73%) bleeding complications, of which one resolved without treatment, two required reoperation, and four required blood transfusions. CONCLUSIONS: Adequate VTE prophylaxis is achieved using calf-length pneumatic compression devices, early ambulation, and relatively short operative times. Pharmacologic anticoagulation is not mandatory when these conditions are met in patients who have no earlier history of VTE. There are few bleeding complications requiring reoperation or blood transfusions without the use of anticoagulants.

Laparoscopic versus open approach for implantation of the peritoneal catheter during ventriculoperitoneal shunt placement.

BACKGROUND: Ventriculoperitoneal shunt (VPS) is the mainstay of therapy for hydrocephalus. The aim of this study is to compare outcomes of laparoscopic (LVPS) versus open (OVPS) techniques for placement of distal VPS catheters. METHODS: All patients undergoing new VPS placement at a tertiary care center between January 2004 and August 2007 were included. Univariate analysis was performed. Wilcoxon rank-sum, chi-square, and Fisher's exact tests were used to make comparisons between LVPS and OVPS groups. Stepwise backward logistic regression was performed to predict complications requiring operative intervention. A Kaplan-Meier estimate of the survival function was calculated for shunt survival. All data is presented as median and range unless otherwise specified. RESULTS: Five hundred thirty-five consecutive patients underwent 579 VPS (258 LVPS, 321 OVPS). Median age (52.0 years) and American Society of Anesthesiologists (ASA) score (3) were similar in LVPS and OVPS groups. Body mass index (BMI) [27.8 (17.0-64.9) kg/m(2) versus 25.9 (12.3-44.4) kg/m(2), p = 0.007], previous operations [0.8 +/- 0.9 versus 0.6 +/- 0.7, p = 0.004 (mean +/- standard deviation)], estimated blood loss (EBL) [20 (0-175) ml versus 25 (0-500) ml, p < 0.001], operating room (OR) time [37.5 (17.0-152.0) min versus 52.0 (20.0-197.0) min, p < 0.001], and length of stay (LOS) [11 (1-77) days versus 14 (1-225) days, p = 0.016] were statistically different between the LVPS and OVPS groups, respectively. LVPS abdominal complication rate of 5.8% and OVPS rate of 6.9% were similar (p = 0.611). Previous abdominal operation [odds ratio (OR) 1.673, 95% confidence interval (CI) 1.100-2.543, p = 0.016] and previous VPS (OR 1.929, 95% CI 1.147-3.243, p = 0.016) were significant predictors of complications requiring operative intervention. Kaplan-Meier analysis demonstrated no difference in survival between LVPS and OVPS groups (p = 0.538), with overall shunt survival of 86.4% at 6 months and 83.0% at 1 year. CONCLUSIONS: LVPS is associated with decreased OR time, less blood loss, and shorter LOS with no difference in complication rate when compared OVPS. The laparoscopic approach for VPS is a safe, effective, and readily reproducible alternative to the traditional open approach.

Appreciation of osteoporosis among men with hyperparathyroidism.

OBJECTIVE: To define the scope of bone disease among men referred for parathyroidectomy and to document bone density screening trends in this high-risk population. METHODS: Clinical data were analyzed from a prospectively maintained database of 1000 patients undergoing parathyroidectomy for sporadic primary hyperparathyroidism at the Cleveland Clinic between 2000 and 2006. Information collected included demographics, reason for referral, body mass index, intraoperative findings, preoperative and postoperative laboratory values (serum calcium, phosphorus, parathyroid hormone, 25-hydroxyvitamin D, and 24-hour urinary calcium excretion), and preoperative and postoperative dual-energy x-ray absorptiometry (DXA) findings. RESULTS: Of the 1000 patients, 243 (24%) were men. As with women, bone health-related issues were the most common reason for referral (32%). In 2000, only 12% of men had preoperative DXA scans; this rose to 42% by 2005. The frequency of prereferral DXA screening increased throughout the study, but even by 2006, referring physicians did not screen most of their male patients. In 2000, the prevalence of bone disease (osteoporosis or osteopenia) in men was 8%, but with improved screening, this increased to 26%, approaching the 34% rate in women. Preoperative and postoperative levels of calcium, parathyroid hormone, phosphorus, 24-hour urinary calcium, and 25-hydroxyvitamin D were the same among men with and without bone disease. Analysis of postoperative DXA scans revealed that gains in postparathyroidectomy bone density were significantly greater in men than in women at all anatomic testing sites. In men, lowest T scores improved by a mean +/- SEM of +0.35 +/- 0.09 compared with +0.098 +/- 0.035 in women (P = .009). Men were 4 times less likely than women to have continued bone loss after parathyroidectomy. CONCLUSIONS: Clinical and laboratory parameters cannot identify men with hyperparathyroidism who have bone loss, illustrating the need for routine DXA screening. Despite this, DXA remains underused. Improved screening practices will favorably effect men's health.

Laparoscopic radiofrequency ablation of unresectable hepatocellular carcinoma: long-term follow-up.

BACKGROUND: Hepatocellular carcinoma (HCC) has seen a dramatic rise in the USA over the last 30 years. Unresectable disease is present in 80-90% of patients, for which radiofrequency ablation (RFA) is an option. The aim of this study is to report the long-term survival after laparoscopic RFA. METHODS: This is a prospective analysis of 104 patients who underwent 122 ablations for unresectable HCC from April 1997 to December 2006 at a tertiary care center. Overall survival (OS) and disease-free survival (DFS) were calculated using Kaplan-Meier curves, excluding 11 patients who subsequently underwent liver transplantation. Patients were analyzed using Child-Pugh classification, Barcelona Clinic Liver Cancer (BCLC) staging and various clinical parameters. RESULTS: Median (range) data: age 63 years (41-81), lesion size 3.5 cm (1-10), number of lesions 1 (1-5), AFP 26.5 ng/ml (3.7-43588.5) and time from diagnosis to RFA 2 months (mos) (1-42). The median Kaplan-Meier survival for all patients was 26 mos (OS) while DFS was 14 mos. Univariate analysis demonstrated improved OS for the absence vs. presence of ascites (31 vs. 15 mos, p=0.003), Bilirubin <2 mg/dl vs. > or = 2 mg/dl (27 vs. 19 mos, p=0.01), AFP <400 vs. > or = 400 (29 vs. 13 mos, p<0.0001) and Child-Pugh Grade (A = 28, B = 15, C = 5 mos, p=0.01). Significant factors for improved DFS: absence vs. presence of ascites (16 vs. 5 mos, p=0.02), Bilirubin <2 vs. > or = 2 (14 vs. 5 mos, p=0.0278), AFP <400 vs. > or = 400 (15 vs. 4 mos, p=0.0025), Child-Pugh Grade (A = 16, B = 10, C = 3 mos, p=0.03). Patient age, largest tumor size, number of lesions, INR and albumin did not reach clinical significance. Three and five-year actual survival rates are 21% and 8.3%, respectively. CONCLUSIONS: Our study suggests that RFA may have a positive impact on survival for unresectable HCC. It also determines which patients fare best after RFA, by determining predictive factors that improve their survival.

Factors contributing to negative parathyroid localization: an analysis of 1000 patients.

BACKGROUND: Localizing studies are the key for determining the optimal surgical strategy in patients with primary hyperparathyroidism (HP). Most of the data in the literature are retrospective in nature and from analysis on a per patient basis. This is a prospective study looking at the characteristics of the patient and the gland that determine the likelihood of an abnormal parathyroid to be detected by ultrasonography (US) and sestamibi scan (MIBI). METHODS: This is a prospective analysis of 1000 consecutive patients with HP who underwent parathyroidectomy at a tertiary care center. The study group included HP with single gland disease (63%), double adenoma (15%), as well as hyperplasia (15%), familial HP (2%), and secondary/tertiary HP (6%). All patients underwent surgeon-performed neck US followed by MIBI scan. Univariate logistic regression and multivariate analyses were performed on pre- and intraoperative variables. RESULTS: A total of 1845 abnormal glands were analyzed. Overall, US was superior to MIBI for the detection of abnormal glands in all subgroups. On multivariate analysis, body mass index (BMI), gland size, and gland volume were the statistically significant independent factors predicting detection by both US and MIBI in primary HP. The sensitivity of US was better for single gland disease than for multigland disease in primary HP, but the sensitivity of MIBI was similar in both groups. For a given size, hyperplastic glands in primary HP imaged less well with US and MIBI than in familial or secondary/tertiary HP. CONCLUSION: This prospective study demonstrates that BMI and gland size independently predict accurate detection of abnormal parathyroid glands by US and MIBI in sporadic primary HP. Understanding the factors that affect the accuracy of parathyroid localization tests will allow the surgeon to develop a successful surgical strategy in a given patient.

Hyperparathyroidism and vitamin D deficiency after laparoscopic gastric bypass.

Hyperparathyroidism (HPT) can occur after gastric bypass because of the alteration in vitamin D and calcium absorption. Adequate serum vitamin D concentrations have not been clearly defined in this patient population. Vitamin D (Vit D) and parathyroid hormone (PTH) were assessed 1 year after laparoscopic gastric bypass (LGB). The prevalence of HPT and Vit D deficiency were determined and their association was evaluated using Fisher's exact test. Ninety-three patients (aged 44 +/- 1.1 years, 49.6 +/- 0.67 Kg/m2 body mass index, 79.6% female, 69.6% white) were evaluated. The prevalence of Vit D deficiency (less than 20 ng/mL) and HPT (greater than 65 pg/mL) was 23.6 per cent (n = 22) and 25.7 per cent (n = 28), respectively. Among patients with HPT, only eight of 28 (28.6%) had Vit D deficiency, and of those with Vit D deficiency, only eight of 22 (36.4%) had HPT. There was a weak inverse correlation (r = -0.37) between PTH and Vit D. Blacks are at higher risk for Vit D deficiency. There was no significant association between Vit D deficiency and HPT, Vit D deficiency and Roux limb length, or HPT and Roux limb length. After LGB, Vit D deficiency and hyperparathyroidism occur commonly. Body mass index and Roux limb length are not associated with these two conditions, but racial differences do exist. There is a weak inverse correlation between Vit D and PTH. Further research is needed to elucidate the causes, treatments, and significance of HPT after LGB.

Laparoscopic versus open ventral hernia repairs: 5 year recurrence rates.

BACKGROUND: Current studies with 2-3 year follow-up favor laparoscopic ventral hernia repair due to lower recurrence rates, fewer wound infections, and shorter hospital stays. There is scant data in the literature for this group of patients regarding longer follow-up. This study compares the actual 5 year recurrence rates of laparoscopic versus open techniques and determines factors that may affect recurrence. METHODS: A retrospective analysis of ventral hernia repairs at a tertiary center between January 1996 and December 2001 was performed. In this era, the method of repair often depended on which surgeon evaluated the patient. All patients were followed for a minimum of 5 years (median 7.5 years). Demographic and clinical parameters were analyzed using Kaplan-Meier analyses and the multivariate Cox proportional hazard model. RESULTS: Of 331 patients, 119 underwent laparoscopic ventral hernia repair (LAP), 106 open hernia repair with mesh (O-M), 86 open suture repair (O-S), and 20 laparoscopic converted to open (LCO). Statistical analyses showed equal parameters among groups except defect sizes (mean +/- standard error on the mean [SEM]): LAP (9.8 +/- 1.2 cm), O-M (11.2 +/- 3.3 cm), LCO (16.6 +/- 5.4 cm) versus O-S (4.6 +/- 1.6 cm) (p < 0.02). Actual recurrence rates at 1 and 5 years were LAP (15% and 29%), O-M (11% and 28%), O-S (10% and 19%), and LCO (35% and 60%). Multivariate analysis identified larger defects to have higher recurrence rates, particularly in the O-S group (p < 0.02). With the exception of the LCO group, surgical technique did not predict recurrence, nor did body mass index, diabetes, smoking, or use of tacks versus sutures. CONCLUSION: This is the first study to compare 5 year actual recurrence rates between laparoscopic and open ventral hernia repairs. Contrary to prior reports, our longer-term data indicates similar recurrence rates, except for higher rates in the laparoscopic converted to open group. Due to the continued recurrences over the period studied, longer-term follow-up is necessary to appreciate the true rate of hernia recurrence.

Survival after radiofrequency ablation of colorectal liver metastases: 10-year experience.

OBJECTIVE: To assess factors affecting long-term survival of patients undergoing radiofrequency ablation (RFA) of colorectal hepatic metastases, with attention to evolving chemotherapy regimens. METHODS: Prospective evaluation of 235 patients with colorectal metastases who were not candidates for resection and/or failed chemotherapy underwent laparoscopic RFA. Preoperative risk factors for survival and pre- and postoperative chemotherapy exposure were analyzed. RESULTS: Two hundred and thirty-four patients underwent 292 RFA sessions from 1997 to 2006, an average of 8 months after initiation of chemotherapy. Twenty-three percent had extrahepatic disease preoperatively. Patients averaged 2.8 lesions, with a dominant diameter of 3.9 cm. Kaplan-Meier actuarial survival was 24 months, with actual 3 and 5 years survival of 20.2% and 18.4%, respectively. Median survival was improved for patients with 3 lesions (27 vs. 17 months, P=0.0018); dominant size<3 versus >3 cm (28 vs. 20 months, P=0.07); chorioembryonic antigen<200 versus >200 ng/mL (26 vs. 16 months, P=0.003). Presence of extrahepatic disease (P=0.34) or type of pre/postoperative chemotherapy (5-FU-leucovorin vs. FOLFOX/FOLFIRI vs. bevacizumab) (P=0.11) did not alter median survival. CONCLUSIONS: To our knowledge, this is both the largest and longest follow-up of RFA for colorectal metastases. The number and dominant size of metastases, and preoperative chorioembryonic antigen value are strong predictors of survival. Despite classic teaching, extrahepatic disease did not adversely affect survival. In this group of patients who failed chemotherapy, newer treatment regimens (pre- or postoperatively) had no survival benefit. The actual 5-year survival of 18.4% in these patients versus near zero survival for chemotherapy alone argues for a survival benefit of RFA.

Gastric bypass in a factor V deficient patient.

Factor V deficiency is a rare bleeding disorder requiring special attention during the peri-operative period. Surgical intervention in these patients can be technically challenging. Because of the rarity of this condition, the optimal management is unknown. Available literature supports peri-operative infusion of fresh frozen plasma. We report successful management of a factor V deficient patient undergoing Roux-en-Y gastric bypass. Literature review indicates that this is the first reported case of bariatric surgery in a patient with factor V deficiency.