When do leaks occur? An analysis of the metabolic and bariatric surgery accreditation and quality improvement program.

BACKGROUND: Leak is a feared complication of bariatric surgeries. Time to presentation is important in their management. We used the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) to evaluate the rate and timing of leaks. OBJECTIVES: To determine when leaks present after bariatric surgery. SETTING: MBSAQIP database. METHODS: The MBSAQIP Participant Use Files (PUF) for the years 2015-2020 were evaluated. Outcomes of interest were "organ space infection" and "leak." We evaluated the time to presentation for these variables as well as patient characteristics, operative time, complication rates and 30-day outcomes. RESULTS: There were 370,369 sleeve gastrectomies (SG) and 159,280 Roux-en-Y gastric bypasses (RYGB). We identified 598 (.16%) SG leaks with an average time to presentation of 13.2 ± 7.8 days. For RYGB, there were 520 leaks (.32%) with an average time to presentation of 9.5 ± 7.4 days. Both procedures had longer operative times for the patients with leak; RYGB was 115 minutes versus 131 minutes and SG was 67 minutes versus 77 minutes (both P < .01). SG and RYGB patients with a leak had a higher relative risk (RR) of grade 4 and 5 Clavien-Dindo complication rates. RR of mortality rates in SG patients with leak was 35.2 (confidence interval (CI): 20-61) and in RYGB with leak was 31.4 (CI: 19-50). CONCLUSIONS: The length of time for SG leak presentation was more delayed than RYGB leak presentation. Surgeons should be vigilant for leaks for at least 3 weeks after surgery. Leaks increase the mortality rate and overall serious complications.

One- versus two-stage conversions of adjustable gastric bands: an analysis of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program database.

BACKGROUND: Laparoscopic adjustable gastric bands (AGB) are converted at high rates to secondary bariatric procedures. The available literature on the safety of converting in 1- versus 2-stage processes has not included large databases. OBJECTIVE: To evaluate the safety of a 1- versus 2-stage conversion of AGB. SETTING: Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP), United States. METHODS: The MBSAQIP database for the years 2020 and 2021 was evaluated. One-stage AGB conversions were identified using Current Procedural Terminology codes and database variables. Multivariable analysis was performed to determine whether 1- or 2-stage conversions were associated with 30-day serious complications. RESULTS: There were 12,085 patients who underwent conversion from previous AGB to sleeve gastrectomy (SG) (63.0%) or Roux-en-Y gastric bypass (RYGB) (37.0%), of whom 41.0% underwent conversion in 1 stage and 59.0% in 2 stages. Patients who underwent 2-stage conversions had higher body mass indexes. Rates of serious complications were higher for patients undergoing RYGB compared with SG (5.2% versus 3.3%, P < .001) but were similar between 1-stage and 2-stage conversions in both cohorts. In both cohorts, there were similar rates of anastomotic leaks, postoperative bleeding, reoperation, and readmissions. Mortality was rare and similar between conversion groups. CONCLUSIONS: There was no difference in outcomes or complications in 30 days between 1- and 2-stage conversions of AGB to RYGB or SG. Conversions to RYGB have higher complication and mortality rates than to SG, but there was no statistically significant difference between staged procedures. One- and 2-stage conversions from AGB are equivalent in safety.

The impact of minimally invasive surgery and frailty on post-hepatectomy outcomes.

BACKGROUND: The impact of patient frailty on post-hepatectomy outcomes is not well studied. We hypothesized that patient frailty is a strong predictor of 30-day post-hepatectomy complications. METHODS: The liver-targeted National Surgical Quality Improvement Program (NSQIP) database for 2014-2019 was reviewed. A validated modified frailty index (mFI) was used. RESULTS: A total of 24,150 hepatectomies were reviewed. Worsening frailty was associated with increased incidence of Clavien-Dindo grade IV complications (mFI 0, 1, 2, 3, 4 was 3.9%, 6.3%, 10%, 8.1%, 50% respectively; p < 0.001). Minimally invasive hepatectomies had a lower rate of Clavien-Dindo grade IV complications for non-frail (Laparoscopic: 1%, Robotic: 2.6%, Open: 4.6%; p < 0.001) and frail patients (Laparoscopic: 3%, Robotic: 2.3%, Open: 7.7%; p < 0.001). Frail patients experienced higher incidence of post-hepatectomy liver failure (5.4% vs 4.1% for non-frail; p < 0.001) and grade C liver failure (28% vs 21.1% for non-frail; p = 0.03). Incorporating mFI to Albumin-Bilirubin score (ALBI) improved its ability to predict Clavien-Dindo grade IV complications (AUC improved from 0.609 to 0.647; p < 0.001) and 30-day mortality (AUC improved from 0.663 to 0.72; p < 0.001). CONCLUSION: Worsening frailty correlates with increased incidence of Clavien-Dindo grade IV complications post-hepatectomy, whereas minimally invasive approaches decrease this risk. Incorporating frailty assessment to ALBI improves its ability to predict major postoperative complications and 30-day mortality.

Stapler Malfunctions in Bariatric Surgery: An Analysis of the MAUDE Database.

Background: Staple line leaks are a serious problem in bariatric surgery and a major cause of serious morbidity and mortality. Adverse events caused by medical devices are reported to the Food and Drug Administration which maintains the Manufacturer and User Facility Device Experience (MAUDE) database. We examined adverse stapler events reported to the MAUDE database, specifically with regards to bariatric surgery. Methods: The MAUDE database was queried for adverse events caused by staplers between January 1, 2018 - December 31, 2020; events reported by Intuitive, Ethicon, and Medtronic/Covidien; and limited our search to "gastric bypass", "sleeve gastrectomy", "stapler malfunction" combined with each company. Results: There were 883 adverse events reported for Medtronic, 353 for Ethicon, and 35 for Intuitive. Approximately 3.5 million staple reloads sold in the study period. The reported misfire rate for Medtronic was 0.04% and for Ethicon was 0.02%. Data for Intuitive was unavailable. The most common reported event for Medtronic was failure to fire (n = 349), followed by misfire (n = 186). For Ethicon, the most common event was failure to fire (n = 146), followed by mechanical problems (n = 27). The most common event with the Intuitive stapler was leak (n = 10) and bleeding from staple line (n = 8). Conclusions: Stapler malfunction is a very rare event in metabolic and bariatric surgery. All of the major stapler producers have transitioned to powered staplers with excellent safety profiles. Open and honest reporting about stapler malfunction is essential to determine the true safety of these ubiquitous devices.

Optimal Surgical Extent for Memory and Seizure Outcome in Temporal Lobe Epilepsy.

OBJECTIVE: Postoperative memory decline is an important consequence of anterior temporal lobe resection (ATLR) for temporal lobe epilepsy (TLE), and the extent of resection may be a modifiable factor. This study aimed to define optimal resection margins for cognitive outcome while maintaining a high rate of postoperative seizure freedom. METHODS: This cohort study evaluated the resection extent on postoperative structural MRI using automated voxel-based methods and manual measurements in 142 consecutive patients with unilateral drug refractory TLE (74 left, 68 right TLE) who underwent standard ATLR. RESULTS: Voxel-wise analyses revealed that postsurgical verbal memory decline correlated with resections of the posterior hippocampus and inferior temporal gyrus, whereas larger resections of the fusiform gyrus were associated with worsening of visual memory in left TLE. Limiting the posterior extent of left hippocampal resection to 55% reduced the odds of significant postoperative verbal memory decline by a factor of 8.1 (95% CI 1.5-44.4, p = 0.02). Seizure freedom was not related to posterior resection extent, but to the piriform cortex removal after left ATLR. In right TLE, variability of the posterior extent of resection was not associated with verbal and visual memory decline or seizures after surgery. INTERPRETATION: The extent of surgical resection is an independent and modifiable risk factor for cognitive decline and seizures after left ATLR. Adapting the posterior extent of left ATLR might optimize postoperative outcome, with reduced risk of memory impairment while maintaining comparable seizure-freedom rates. The current, more lenient, approach might be appropriate for right ATLR. ANN NEUROL 2022;91:131-144.

The Impact of the COVID-19 Pandemic on Resident Physicians Well-Being in the Surgical and Primary Care Specialties in the United States and Canada.

PURPOSE:  The COVID-19 pandemic disrupted the professional, social, and spiritual activities of resident physicians around the world, impacting wellness and personal relationships. Moreover, social distancing caused significant limitations or shutdown of places of worship, including churches, synagogues, mosques, etc. Our goal was to survey resident physicians in primary care and surgical subspecialties in the United States (U.S.) and Canada and to examine the effect of the COVID-19 pandemic on their well-being. METHODS:  An international cross-sectional study was performed in November 2020, using an anonymous survey of programs in the U.S. and Canada, containing 20 questions to assess the impact of the pandemic on resident participation in social and spiritual activities and the effects on their wellness, and personal relationships. The emails with survey links attached were sent to individual program coordinators from accredited residency training programs in the United States and Canada. This consisted of programs accredited by the American Osteopathic Association (AOA), The Royal College of Physicians and Surgeons of Canada (RCPSC), and the Accreditation Council of Graduate Medical Education (ACGME). The survey was evenly divided among surgical programs (General Surgery, Neurological Surgery, Orthopedic Surgery, Urological Surgery, and Integrated Surgical Residency Programs such as Plastic Surgery, Cardiothoracic Surgery, Pediatric Surgery, and Vascular Surgery) as well as primary care programs (Internal Medicine and Family Medicine). RESULTS:  A total of 196 residents, 60 primary care residents, and 136 surgery residents participated in the study. Ninety-six participants (49%) were female, and 98 of the participants (50%) were male, with the remainder two residents identifying as "Other." Of the primary care residents, the majority (39, 65%) were female. Conversely, the majority (77, 57%) of surgery residents were male. CONCLUSION:  The COVID-19 pandemic has affected the social lives, relationships, and spiritual well-being of both surgical and primary care resident physicians. However, primary care residents reported significantly greater engagement in personal relationships and were more likely to express feelings of mental and physical exhaustion, prohibiting social attendance.

Facility Type Affects Treatment Outcomes for Patients With Mucinous Cystic Neoplasms and Intraductal Papillary Mucinous Neoplasms of the Pancreas.

OBJECTIVE: Academic centers report better outcomes for pancreatic ductal adenocarcinoma. We hypothesized that treatment outcomes for mucinous cysts differ according to institution type. METHODS: Using the National Cancer Data Base, we analyzed data on patients with mucinous cystic neoplasms (MCNs) and intraductal papillary mucinous neoplasms (IPMNs). RESULTS: Of 3278 identified patients, 2622 (80%) had IPMNs and 656 (20%) had MCNs. While most academic/research programs (ARCPs, 84.9%) treated more than 10 patients/year, this was true for only 59% of integrated network cancer programs, 37.3% of comprehensive community cancer programs, and 0% of community cancer programs (P < 0.001). Surgery was used more often in ARCPs and for smaller tumors. The ARCPs had higher rates of margin negative resections with retrieval of 15 or more nodes with the lowest 30- and 90-day mortality rates. The median overall survival was better in ARCPs (110.3 months) than comprehensive community cancer programs (75.1 mo), community cancer programs (75.1 mo), or integrated network cancer programs (100.8 mo, P < 0.001). CONCLUSIONS: Treatment of MCNs and IPMNs of the pancreas at academic centers is associated with a higher probability of pancreatectomy, disease identification in a noninvasive stage, and better overall survival. Centralization of care for mucinous pancreatic cysts will lead to improved outcomes.

Impact of facility type on survival after pancreatoduodenectomy for small pancreatic adenocarcinoma (≤ 2 cm).

BACKGROUND: Previous studies have demonstrated that even small pancreatic cancers are associated with poor survival. The role of facility type on survival in this setting is unknown. STUDY DESIGN: The National Cancer Database (NCDB) was utilized. Patients who underwent pancreatoduodenectomy for adenocarcinoma ≤ 2 cm in Academic/Research Cancer Programs (ACPs) were compared to Non-Academic Cancer Programs (NACPs). RESULTS: A total of 4672 patients were identified. Surgery at ACPs was associated with a lower rate of positive margins (14% vs 17%,P < .0001) and a higher rate of lymphadenectomy ≥15 nodes (49.6% vs 36.3%,P < .0001). Over 75% of the ACPs facilities were high volume vs 25.5% among NACPs. There was no difference in the odds of delivering chemotherapy in the neoadjuvant or adjuvant setting between ACPs and NACPs. The median survival at ACPs was 29.4 months vs 25.7 months at NACPs (Log-rank test:P < .0001). ACPs were associated with improved survival, adjusted Hazard Ratio: 0.88, 95%CI:0.81-0.96. CONCLUSION: Pancreatoduodenectomy for small pancreatic cancers at ACPs is associated with improved survival compared to NACPs.

Mucinous cystic neoplasms of the pancreas in the modern era. Experience with 707 patients.

BACKGROUND: Mucinous Cystic Neoplasms are mucin producing cysts of the pancreas with malignant potential. The existing literature on treatment outcomes is limited to relatively small surgical series. METHODS: We reviewed the National Cancer Database assessing the outcomes of patients with mucinous cystic neoplasms between 2004 and 2016. Kaplan-Meier method and log rank test were used to make survival comparisons. RESULTS: A total of 707 patients were identified; 492(69.6%) underwent pancreatectomies. The majority of patients were women (71.4%), with median age 65 years (range: 22-90). Most common operation was partial pancreatectomy ie distal (48.4%) whereas 21.7% underwent a Whipple. Patients who were not operated were more frequently stage IV (40%) whereas patients who were operated had more frequently invasive adenocarcinoma (74.8%). Patients who underwent pancreatectomy had better survival compared to these who didn't undergo surgery (81.4 vs 6.6 months; p < 0.001). Comparing patients who underwent pancreatectomy and had invasive disease versus patients who had in situ disease the former were older (median age 62 vs 55.5 years p = 0.004) and more frequently men (26.1 vs 16.1%; p = 0.03), however they had similar tumor size (5.5 vs 7 cm respectively; p = 0.14) and similar tumor differentiation (moderately differentiated 50% vs 38.1%; p = 0.49). Patients with non-invasive (in situ) disease had prolonged survival compared to these with invasive disease (median OS not reached vs 50.2months; p < 0.001). After Cox proportional hazard regression nodal positive disease was the most important factor of decreased survival for invasive adenocarcinoma (HR: 2.2; p < 0.001). CONCLUSION: Patients with adenocarcinoma arising from a mucinous cystic neoplasm of the pancreas have excellent survival when they undergo pancreatectomy especially if the disease is still in situ. However, 3/4 of patients who undergo resection have already developed invasive adenocarcinoma and nodal status dominates their prognosis. Advanced age but not the size of the cyst correlate with the presence of invasive disease.

Development and validation of an HPLC-UV method for accelerated stability study and pharmacokinetic analysis of venlafaxine

A reverse phase high performance liquid chromatography method has been developed and validated for accelerated stability study and determination of pharmacokinetic parameters of venlafaxine HCl. The chromatographic separation was carried out using ODS analytical column (250 × 4.6 mm i.d., 5 µm particle size). The mobile phase included acetonitrile, methanol and potassium dihydrogen phosphate buffer (30:30:40; pH 6.1) at a flow rate 1.5 mL min−1. UV-Visible detector was used at wavelength of 227 nm to monitor elutions. Retention time observed was 2.745 min. The method was validated for linearity, accuracy, precision, sensitivity and robustness. Accelerated stability study of venlafaxine HCl capsules was carried out at 40 and 50 ºC under 75% RH level. Suggested method was successfully applied for the pharmacokinetic analysis of venlafaxine hydrochloride tablets. Each of ten albino rabbits (≈ 1.2 kg each) was orally administered with 5 mg dose of venlafaxine HCl. The method was proved to be linear (R2 >0.998), accurate (98.25-99.27%), sensitive (LOD: 35ngmL−1; LOQ: 105 ng mL−1) and robust (RSD<1%). The drug showed stability at accelerated conditions of temperature and humidity. The main pharmacokinetic parameters of tested products were as follows: tmax was 2.5h, Cmax was 56.5 µg mL−1, t1/2 was 8.2 h, AUC0-36 was 845.9 µg h mL−1. The developed method is suitable to apply for quality control analysis and pharmacokinetic studies.

Acute kidney injury in lymphoma: a single centre experience.

Background. Acute kidney injury (AKI) is a common but least studied complication of lymphoma. Objective. To determine the frequency and predictors of AKI in lymphoma and to study the impact of AKI on hospital stay and mortality. Methods. Retrospective review of medical records of hospitalized lymphoma patients aged ≥14 years between January 2008 and December 2011 was done. Results. Out of 365 patients, AKI was present in 31.8% (116/365). Multivariate logistic regression analysis showed that independent predictors for AKI included sepsis (odds ratio (OR) 3.76; 95% CI 1.83-7.72), aminoglycosides (OR 4.75; 95% CI 1.15-19.52), diuretics (OR 2.96; 95% CI 1.31-6.69), tumor lysis syndrome (OR 3.85; 95% CI 1.54-9.59), and R-CVP regimen (OR 4.70; 95% CI 1.20-18.36). AKI stages 2 and 3 was associated with increased hospital stay (OR 2.01; 95% CI 1.19-3.40). Conclusion. AKI was significantly associated with sepsis, aminoglycoside, diuretics, presence of tumor lysis syndrome, and use of R-CVP regimen. Presence of AKIN (Acute Kidney Injury Network) stages 2 and 3 AKI had increased hospital stay. AKI was also associated with increased mortality.

Synchronous presentation of breast carcinoma with plasmacytoid cytomorphology and multiple myeloma.

Plasmacytoid morphology is often encountered in both lobular and ductal carcinomas of the breast. The presentation of breast carcinoma in patients with a known history of lymphoma or multiple myeloma has been described in the literature. However, to the best of our knowledge, the synchronous presentation of breast carcinoma and multiple myeloma has not been reported. Here we report the first case of the simultaneous occurrence of breast carcinoma with plasmacytoid morphology and multiple myeloma in a 74-year-old patient, which presented challenges in making the diagnosis on fine-needle aspiration biopsy (FNAB) of the breast.