Phase 1 randomized trial of inpatient high-intensity interval training after major surgery.

BACKGROUND: High-intensity interval training (HIT) can provide physiologic benefits and may improve postoperative recovery but has not been evaluated in inpatients. This study aimed to evaluate the safety and tolerability of HIT after major surgery. METHODS: We performed a phase I randomized study comparing HIT with low-intensity continuous ambulation (40 m) during the initial inpatient stay after major surgery at a large academic center. Clinicopathologic and pre- and post-exercise physiologic data were captured. Perceived exertion was measured throughout the intervention. RESULTS: Twenty-two subjects were enrolled and randomized with 90% (20 subjects, 10 per arm) completing all aspects of the study. One patient declined participation in the exercise intervention. The HIT and continuous ambulation groups were relatively similar in terms of median age (65.5 vs 63.5), female sex (20% vs 40%), White race (90% vs 90%), having a cancer diagnosis (100% vs 80%), undergoing gastrointestinal surgery (60% vs 80%), median Karnofsky score (60 vs 60), and ability to independently ambulate preoperatively (100% vs 90%). All subjects completed the exercise without protocol deviation, cohort crossover, or safety events. Compared with the continuous ambulation group, the HIT group had higher end median perceived exertion (5.0 [IQR, 5.5] vs 3.0 [IQR, 1.8]), shorter overall time to complete assigned exercise (56.6 seconds vs 91.8 seconds), and a trend toward higher median gait speed over 40 m (0.71 m/s vs 0.44 m/s, P = .126). CONCLUSION: HIT in the hospitalized postoperative patient is safe and may be implemented to help promote positive physiologic outcomes and recovery.

Society for Surgery of the Alimentary Tract State-of-the-Art Session 2022: Frailty in Surgery.

Given the exponentially aging population and rising life expectancy in the United States, surgeons are facing a challenging frail population who may require surgery but may not qualify based on their general fitness. There is an urgent need for greater awareness of the importance of frailty measurement and the implementation of universal assessment of frail patients into clinical practice. Pairing risk stratification with stringent protocols for prehabilitation and minimally invasive surgery and appropriate enhanced recovery protocols could optimize and condition frail patients before, during, and immediately after surgery to mitigate postoperative complications and consequences on patient function and quality of life. In this paper, highlights from the 2022 Society for Surgery of the Alimentary Tract State-of-the-Art Session on frailty in surgery are presented. This work aims to improve the understanding of the impact of frailty on patients and the methods used to augment the outcomes for frail patients during their surgical experience.

Pancreatic Myeloid Sarcoma Causing Obstructive Jaundice: A Case Report and Literature Review.

Myeloid sarcoma (MS) is an extramedullary manifestation of acute myeloid leukemia (AML) and commonly occurs in sites such as the lymph nodes, skin, soft tissues, and bone. It more rarely manifests in the pancreas, with less than 20 cases reported in the literature since 1987. Despite its rarity, MS should be considered in the differential diagnosis of a soft tissue mass causing obstructive jaundice, especially if the patient has a known hematologic disease. Isolated cases of pancreatic MS have been known to progress to AML; therefore, it is crucial to differentiate MS from more common diagnoses, such as pancreatic cancer or pancreatitis. This is a case of a 70-year-old male with symptomatic obstructive jaundice secondary to pancreatic MS, ultimately requiring endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP) for diagnosis and management. Also included is a comprehensive review of previous case reports with similar clinical presentations, management, and treatment of pancreatic MS.

A location-based anatomic classification system for acute pancreatic fluid collections: Roadmap for optimal intervention in the step-up era.

Walled-off pancreatic necrosis (WOPN) is a local complication of acute necrotizing pancreatitis frequently requiring intervention. Treatment is typically through the coordinated efforts of a multidisciplinary team. Current management guidelines recommend a step-up approach beginning with minimally invasive techniques (percutaneous or transmural endoscopic drainage) followed by escalation to more invasive procedures if needed. Although the step-up approach is an evidence-based treatment paradigm for management of pancreatic fluid collections, it lacks guidance regarding optimal invasive technique selection based on the anatomic characteristics of pancreatic fluid collections. Similarly, existing cross-sectional imaging-based classification systems of pancreatic fluid collections have been used to predict disease severity and prognosis; however, none of these systems are designed to guide intervention. We propose a novel classification system which incorporates anatomic characteristics of pancreatic fluid collections (location and presence of disconnected pancreatic duct) to guide intervention selection and clinical decision making. We believe adoption of this simple classification system will help streamline treatment algorithms and facilitate cross-study comparisons for pancreatic fluid collections.

Distinguishing Clinical from Statistical Significances in Contemporary Comparative Effectiveness Research.

OBJECTIVE: To determine the prevalence of clinical significance reporting in contemporary comparative effectiveness research (CER). BACKGROUND: In CER, a statistically significant difference between study groups may or may not be clinically significant. Misinterpreting statistically significant results could lead to inappropriate recommendations that increase healthcare costs and treatment toxicity. METHODS: CER studies from 2022 issues of Annals of Surgery, Journal of the American Medical Association, Journal of Clinical Oncology, Journal of Surgical Research, and Journal of the American College of Surgeons were systematically reviewed by two different investigators. The primary outcome of interest was whether authors specified what they considered to be a clinically significant difference in the Methods. RESULTS: Of 307 reviewed studies, 162 were clinical trials and 145 were observational studies. Authors specified what they considered to be a clinically significant difference in 26 studies (8.5%). Clinical significance was defined using clinically validated standards in 25 studies and subjectively in 1 study. Seven studies (2.3%) recommended a change in clinical decision-making, all with primary outcomes achieving statistical significance. Five (71.4%) of these studies did not have clinical significance defined in their methods. In randomized controlled trials with statistically significant results, sample size was inversely correlated with effect size (r=-0.30, P=0.038). CONCLUSION: In contemporary CER, most authors do not specify what they consider to be a clinically significant difference in study outcome. Most studies recommending a change in clinical-decision making did so based on statistical significance alone, and clinical significance was usually defined with clinically validated standards.

Risk factors and outcomes for cholangitis after hepatic resection.

INTRODUCTION: There is a paucity in the literature in regard to the incidence, risk factors, and outcomes for post-operative cholangitis following hepatic resection. METHODS: Retrospective review of the ACS NSQIP main and targeted hepatectomy registries for 2012-2016. RESULTS: A total of 11,243 cases met the selection criteria. The incidence of post-operative cholangitis was 0.64% (151 cases). Multivariate analysis identified several risk factors associated with the development of post-operative cholangitis, stratified out by pre-operative and operative factors. The most significant risk factors were biliary anastomosis and pre-operative biliary stenting with odds ratios (OR) of 32.39 (95% CI 22.91-45.79, P value < 0.0001) and 18.32 (95% CI 10.51-31.94, P value < 0.0001) respectively. Cholangitis was significantly associated with post-operative bile leaks, liver failure, renal failure, organ space infections, sepsis/septic shock, need for reoperation, longer length of stay, increased readmission rates, and death. CONCLUSION: Largest analysis of post-operative cholangitis following hepatic resection. While a rare occurrence, it is associated with significantly increased risk for severe morbidity and mortality. The most significant risk factors were biliary anastomosis and stenting.

Comparison of survival for metastatic pancreatic cancer patients treated with CPI-613 versus resected borderline-resectable pancreatic cancer patients.

INTRODUCTION: Treatment of advanced pancreatic adenocarcinoma remains suboptimal. Therapeutic agents with a novel mechanism of action are desperately needed; one such novel agent is CPI-613 targets. We here analyze the outcomes of 20 metastatic pancreatic cancer patients treated with CPI-613 and FOLFIRINOX in our institution and evaluate their outcomes to borderline-resectable patients treated with curative surgery. METHODS: A post hoc analysis was performed of the phase I CPI-613 trial data (NCT03504423) comparing survival outcomes to borderline-resectable cases treated with curative resection at the same institution. Survival was measured by overall survival (OS) for all study cases and disease-free survival (DFS) for resected cases with progression-free survival for CPI-613 cases. RESULTS: There were 20 patients in the CPI-613 cohort and 60 patients in the surgical cohort. Median follow-up times were 441 and 517 days for CPI-613 and resected cases, respectively. There was no difference in survival times between CPI-613 and resected cases with a mean OS of 1.8 versus 1.9 year (p = 0.779) and mean PFS/DFS of 1.4 versus 1.7 years (p = 0.512). There was also no difference in 3-year survival rates for OS (hazard ratio [HR] = 1.063, 95% confidence interval [CI] 0.302-3.744, p = 0.925) or DFS/PFS (HR = 1.462, 95% CI 0.285-7.505, p = 0.648). CONCLUSION: The first study to evaluate the survival between metastatic patients treated with CPI-613 versus borderline-resectable cases undergoing curative resection. Analysis revealed no significant differences in survival outcomes between the cohorts. Study results are suggestive that there may be potential utility with the addition of CPI-613 to potentially resectable pancreatic adenocarcinoma, although additional research with more comparable study groups are required.

Incidence, severity and detection of blood pressure and heart rate perturbations in postoperative ward patients after noncardiac surgery.

STUDY OBJECTIVE: We sought to determine changes in continuous mean and systolic blood pressure and heart rate in a cohort of non-cardiac surgical patients recovering on the postoperative ward. Furthermore, we estimated the proportion of vital signs changes that would remain undetected with intermittent vital signs checks. DESIGN: Retrospective cohort. SETTING: Post-operative general ward. PATIENTS: 14,623 adults recovering from non-cardiac surgical procedures. INTERVENTIONS & MEASUREMENTS: Using a wireless, noninvasive monitor, we recorded postoperative blood pressure and heart rate at 15-s intervals and encouraged nursing intervention as clinically indicated. MAIN RESULTS: 7% of our cohort of 14,623 patients spent >15 sustained minutes with a MAP <65 mmHg, and 23% had MAP <75 mmHg for 15 sustained minutes. Hypertension was more common, with 67% of patients spending at least 60 sustained minutes with MAP >110 mmHg. Systolic pressures <90 mmHg were present for 15 sustained minutes in about a fifth of all patients, and 40% of patients had pressures >160 mmHg sustained for 30 min. 40% of patients were tachycardic with heart rates >100 beats/min for at least continuous 15 min and 15% of patients were bradycardic at a threshold of <50 beats/min for 5 sustained minutes. Conventional vital sign assessments at 4-h intervals would have missed 54% of mean pressure episodes <65 mmHg sustained >15 min, 20% of episodes of mean pressures >130 mmHg sustained >30 min, 36% of episodes of heart rate > 120 beats/min sustained <10 min, and 68% of episodes of heart rate sustained <40 beats per minute for >3 min. CONCLUSIONS: Substantial hemodynamic disturbances persisted despite implementing continuous portable ward monitoring coupled with nursing alarms and interventions. A significant proportion of these changes would have gone undetected using traditional intermittent monitoring. Better understanding of effective responses to alarms and appropriate interventions on hospital wards remains necessary.

Association Between Mobilization and Composite Postoperative Complications Following Major Elective Surgery.

Importance: Mobilization after surgery is a key component of Enhanced Recovery after Surgery (ERAS) pathways. Objective: To evaluate the association between mobilization and a collapsed composite of postoperative complications in patients recovering from major elective surgery as well as hospital length of stay, cumulative pain scores, and 30-day readmission rates. Design, Setting, and Participants: This retrospective observational study conducted at a single quaternary US referral center included patients who had elective surgery between February 2017 and October 2020. Mobilization was assessed over the first 48 postoperative hours with wearable accelerometers, and outcomes were assessed throughout hospitalization. Patients who had elective surgery lasting at least 2 hours followed by at least 48 hours of hospitalization were included. A minimum of 12 hours of continuous accelerometer monitoring was required without missing confounding variables or key data. Among 16 203 potential participants, 8653 who met inclusion criteria were included in the final analysis. Data were analyzed from February 2017 to October 2020. Exposures: Amount of mobilization per hour for 48 postoperative hours. Outcomes: The primary outcome was a composite of myocardial injury, ileus, stroke, venous thromboembolism, pulmonary complications, and all-cause in-hospital mortality. Secondary outcomes included hospital length of stay, cumulative pain scores, and 30-day readmission. Results: Of 8653 included patients (mean [SD] age, 57.6 [16.0] years; 4535 [52.4%] female), 633 (7.3%) experienced the primary outcome. Mobilization time was a median (IQR) of 3.9 (1.7-7.8) minutes per monitored hour overall, 3.2 (0.9-7.4) in patients who experienced the primary outcome, and 4.1 (1.8-7.9) in those who did not. There was a significant association between postoperative mobilization and the composite outcome (hazard ratio [HR], 0.75; 95% CI, 0.67-0.84; P < .001) for each 4-minute increase in mobilization. Mobilization was associated with an estimated median reduction in the duration of hospitalization by 0.12 days (95% CI, 0.09-0.15; P < .001) for each 4-minute increase in mobilization. The were no associations between mobilization and pain score or 30-day readmission. Conclusions and Relevance: In this study, mobilization measured by wearable accelerometers was associated with fewer postoperative complications and shorter hospital length of stay.

Outcomes for patients with dementia undergoing emergency and elective colorectal surgery: A large multi-institutional comparative cohort study.

BACKGROUND: Alzheimer's Disease and Related Dementias (ADRD) may result in poor surgical outcomes. The current study aims to characterize the risk of ADRD on outcomes for patients undergoing colorectal surgery. METHODS: Colorectal surgery patients with and without ADRD from 2007 to 2017 were identified using electronic health record-linked Medicare claims data from two large health systems. Unadjusted and adjusted analyses were performed to evaluate postoperative outcomes. RESULTS: 5926 patients (median age 74) underwent colorectal surgery of whom 4.8% (n = 285) had ADRD. ADRD patients were more likely to undergo emergent operations (27.7% vs. 13.6%, p < 0.001) and be discharged to a facility (49.8% vs 28.9%, p < 0.001). After multi-variable adjustment, ADRD patients were more likely to have complications (61.1% vs 48.3%, p < 0.001) and required longer hospitalization (7.1 vs 6.1 days, p = 0.001). CONCLUSIONS: The diagnosis of ADRD is an independent risk factor for prolonged hospitalization and postoperative complications after colorectal surgery.

Large Canal of Nuck Hernia: The Female Equivalent of the Inguinoscrotal Hernia.

Our patient was a 78-year-old woman with a large indirect inguinal hernia who underwent Lichtenstein repair. Literature review of the pathophysiology of indirect hernias revealed important discussion of the canal of Nuck in women and understanding embryologic development of ovaries and descent of testes.

Effect of preoperative liver-directed therapy prior to hepatic resection.

INTRODUCTION: Hepatobiliary malignancies present with advanced disease precluding upfront resection. Liver-directed therapy (LDT), particularly Y-90 radioembolization and transarterial chemoembolization (TACE), has become increasingly utilized to facilitate attempt at oncologic resection. However, the safety profile of preoperative LDT is limited. METHODS: Retrospective review of the ACS NSQIP main and targeted hepatectomy registries for 2014-2016. Primary objective was evaluation of outcomes between preoperative LDT cases and those that received upfront resection. RESULTS: A total of 8923 cases met selection criteria. 192 cases (2.15%) received either Y-90 or TACE prior to hepatectomy. Multivariate analysis for all study patients revealed preoperative LDT significantly increased the risk of perioperative transfusion (OR 2.19, 95% CI 1.445-3.328, P < 0.0001), sepsis (OR 2.21, 95% CI 1.104-4.411, P = 0.022), and liver failure (OR 2.72, 95% CI 1.562-4.747, P < 0.0001). Subgroup analysis found for primary hepatobiliary malignancies LDT only increased the risk for liver failure. While for secondary hepatic tumors LDT significantly increased perioperative transfusion, sepsis, cardiac failure, renal failure, liver failure, and mortality. The complication profile also significantly increased with advanced T stage. Conversely, on propensity score matching preoperative LDT did not significantly increase perioperative complications. CONCLUSION: Preoperative LDT has the potential to convert inoperable hepatic tumors into resectable disease but there is a general increased risk for significant postoperative complications, most notable liver failure. However, on controlled analysis preoperative LDT does not increase perioperative complications and should not be considered a contraindication to resection.

Indications for Operative Management of Complicated Duodenal Diverticula: A Review.

The duodenum is the second most common location for a diverticulum to form after the colon. These duodenal diverticula (DD) are often found incidentally and rarely require intervention. In recent years, surgical management has been restricted to patients with significant complicated sequelae, such as perforation, abscess, or fistula formation. We present the rare case of a perforated broad-based diverticulum in the third portion of the duodenum necessitating surgical correction. The patient presented with persistent symptoms following failure of conservative management and underwent surgical resection. Due to difficulty visualizing the extent of the diverticulum, a novel intraoperative technique of bowel insufflation via nasogastric tube was used allowing for elucidation of the diverticular borders and complete resection. Although DD are common, there exists no consensus on when operative intervention is indicated. Given that significant morbidity and mortality can be associated with symptomatic DD, a systematic way to guide management decisions is needed. After conducting a review of the literature, we propose that the modified Hinchey classification can be used not only to categorize duodenal diverticulitis but to guide treatment choice in cases with unclear risk benefit profiles.

High-risk liver patients are not associated with adverse events following pancreaticoduodenectomy.

INTRODUCTION: Pancreaticoduodenectomy performed with underlying hepatic disease has been reported to have increased adverse events postoperatively. This study aimed to further evaluate that association. METHODS: Retrospective review of the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) main and targeted pancreatectomy registries for 2014-2016. High-risk liver patients were defined by MELD scores, received neoadjuvant chemotherapy, and had hepatosteatosis; two separate subgroups of MELD ≥9 and ≥ 11. High-risk liver patients were then compared to control cases via propensity score matching. RESULTS: There were 156 and 132 cases that met the high-risk liver criteria for the MELD cutoffs of ≥9 and ≥ 11 respectively. Propensity score matching left 2527 cases for final adjusted analysis. On both univariate and multivariate analysis high-risk liver patients were not associated with increased adverse events following Whipple resection. Lack of association with increased adverse events held for both the ≥9 and ≥ 11 MELD score cohorts. CONCLUSION: High-risk liver patients defined by MELD scores, neoadjuvant chemotherapy utilization, and hepatosteatosis were not associated with any increased incidence of adverse events following pancreaticoduodenectomy. Patients with underlying high-risk liver disease in this study did not appear to pose as a contraindication for oncologic resection of pancreatic adenocarcinoma.

Patients living with dementia have worse outcomes when undergoing high-risk procedures.

BACKGROUND: Patients with Alzheimer's Disease and Related Dementias (ADRD) undergoing inpatient procedures represent a population at elevated risk for adverse outcomes including postoperative complications, mortality, and discharge to a higher level of care. Outcomes may be particularly poor in patients with ADRD undergoing high-risk procedures. We sought to determine traditional (e.g., 30-day mortality) and patient-centered (e.g., discharge disposition) outcomes in patients with ADRD undergoing high-risk inpatient procedures. METHODS: This retrospective cohort study analyzed electronic health records linked to fee-for-service Medicare claims data at a tertiary care academic health system. All patients from a large multi-hospital health system undergoing high-risk inpatient procedures from October 1, 2015 to September 30, 2017 with continuous Medicare Parts A and B enrollment in the 12 months prior to and 90 days following the procedure were included. RESULTS: This study included 6779 patients. 536 (7.9%) had ADRD. A multivariable analysis of outcomes demonstrated higher risks for postoperative complications (OR 1.49, 95% CI 1.23-1.81) and 90-day mortality (OR 1.44 [95% CI 1.09-1.91]) in patients with ADRD compared to those without. Patients with ADRD were more likely to be discharged to a higher level of care (OR 1.70, 95% CI 1.32-2.18) and only 37.3% of patients admitted from home were discharged to home. CONCLUSIONS: Compared to those without ADRD, patients living with ADRD undergoing high-risk procedures have poor traditional and patient-centered outcomes including increased risks for 90-day mortality, postoperative complications, longer hospital lengths of stay, and discharge to a higher level of care. These data may be used by patients, their surrogates, and their physicians to help align surgical decision-making with health care goals.

Use of a Multi-Sensor Monitoring Device in an Early Post-operative Mobilization Program.

BACKGROUND: The current study aimed to evaluate the validity and feasibility of using a multi-sensor device to monitor patient mobility in a large postoperative population. METHODS: In this IRB-approved study, postoperative patient posture was recorded using a multi-sensor monitoring device (ViSi Mobile®) and compared with direct observations of patient physical activity. Retrospective cohort analysis of postoperative patient posture data from January to December 2019 was then performed. Patterns of postoperative mobilization were evaluated. RESULTS: Multi-sensor real-time posture monitoring with the ViSi Mobile® system consistently differentiate between rest and upright posture (sensitivity and specificity, both 100%). During observation of ambulatory events, ViSi Mobile® system correctly recorded a patient's position as upright at each validation time point in 72.7% (8 of 11) of walks. Clinical data from 562 postoperative patients were linked with posture monitoring data. Median duration of posture monitoring was 64 hours (IQR 52.5) and median number of posture positions recorded per patient was 15,370 (IQR 12,685). Median duration of upright position per day was 148.6 minutes (IQR 192.8). Duration in active upright position per day was not associated with risk of readmission (P > .05). CONCLUSION: Real-time posture data from a multi-sensor monitoring device (ViSi Mobile®) was shown to consistently differentiate rest and active upright position. This novel technology can provide useful insight into adherence and clinical benefit of early mobilization programs.

Prognostic Effect of Aberrant Right Hepatic Artery with Pancreaticoduodenectomy: Focus on Hepatic Recurrence.

INTRODUCTION: Metastatic progression occurs along the locoregional vasculature, and a common anatomic variant is an aberrant right hepatic artery (aRHA). This study evaluated the effect of an aRHA following pancreaticoduodenectomy, with a focus on hepatic metastases. METHODS: This was a single-institution retrospective review of non-metastatic pancreatic cancer cases between 2012 and 2020. aRHA cases were compared with patients with conventional anatomy. The primary outcome was hepatic recurrence rates, while secondary analysis survival outcomes were measured by overall survival (OS) and disease-free survival (DFS). Subgroup analysis was stratified by tumor resectability and utilization of systemic therapy. RESULTS: Overall, 207 cases were reviewed, with 17.4% having aRHA anatomy. On multivariate analysis, aRHA increased hepatic recurrence for all-comers (odds ratio [OR] 4.76, 95% confidence interval [CI] 2.18-10.38; p < 0.001). aRHA was significant for resectable tumors (OR 2.58, 95% CI 1.89-6.66; p = 0.045) and borderline resectable tumors (OR 28.88, 95% CI 5.52-151.18; p < 0.0001) in regard to hepatic recurrence on univariate analysis. Increased hepatic recurrence correlated with decreased 3-year OS and DFS rates of 30.6% versus 50.3% (OR 0.44, 95% CI 0.20-0.94; p = 0.032) and 13.6% versus 36.9% (OR 0.27, 95% CI 0.08-0.97; p = 0.035). Systemic therapy limited the effects of aRHA. CONCLUSION: aRHA was associated with inferior survival outcomes due to the significantly increased risk of hepatic metastatic disease with aberrant anatomy. This study provides important prognostic information for a commonly encountered anatomic variant.