Open Retromuscular Sugarbaker vs Keyhole Mesh Placement for Parastomal Hernia Repair: A Randomized Clinical Trial.

Importance: Durable parastomal hernia repair remains elusive. There is limited evidence comparing the durability of the open retromuscular Sugarbaker and keyhole mesh configurations. Objective: To determine if the open retromuscular Sugarbaker mesh placement technique would lower parastomal hernia recurrence rates. Design, Setting, and Participants: In this single-center, randomized clinical trial, 150 patients with a permanent stoma and associated parastomal hernia who were candidates for open retromuscular parastomal hernia repair were enrolled and randomized from April 2019 to April 2022 and followed up for 2 years. Interventions: Following intraoperative assessment to determine the feasibility of either technique, enrolled patients were randomized to receive either retromuscular Sugarbaker or keyhole synthetic mesh placement. Main Outcomes and Measures: The primary outcome was parastomal hernia recurrence at 2 years. Secondary outcomes included mesh-related complications, wound complications, reoperations, as well as patient-reported pain, abdominal wall-specific quality of life, stoma-specific quality of life, and decision regret at 1 year and 2 years. Results: A total of 150 patients were randomized, and with 91% follow-up at 2 years, there were 13 (17%) parastomal hernia recurrences in the retromuscular Sugarbaker arm and 18 (24%) in the keyhole arm (adjusted risk difference, -0.029; 95% CI, -0.17 to 0.153, and adjusted risk ratio, 0.87; 95% CI, 0.42 to 1.69). There were no statistically significant differences between the Sugarbaker and keyhole groups regarding reoperations for recurrence (2 vs 7, respectively), nonhernia intra-abdominal pathology (4 vs 10, respectively), stoma necrosis (1 vs 0, respectively), mesh-related complications (4 vs 1, respectively), patient-reported pain, abdominal wall-specific quality of life, stoma-specific quality of life, and decision regret at any time point. Conclusions and Relevance: In the setting of open parastomal hernia repair, a retromuscular Sugarbaker mesh placement technique was not superior to a keyhole configuration 2 years after repair. Further innovation is necessary to improve parastomal hernia repair outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT03972553.

The Effects of Post-Exercise Cold Water Immersion on Neuromuscular Control of Knee.

To date, most studies examined the effects of cold water immersion (CWI) on neuromuscular control following exercise solely on measuring proprioception, no study explores changes in the brain and muscles. The aim of this study was to investigate the effects of CWI following exercise on knee neuromuscular control capacity, and physiological and perceptual responses. In a crossover control design, fifteen participants performed an exhaustion exercise. Subsequently, they underwent a 10 min recovery intervention, either in the form of passively seated rest (CON) or CWI at 15 °C. The knee proprioception, oxygenated cerebral hemoglobin concentrations (Δ[HbO]), and muscle activation during the proprioception test, physiological and perceptual responses were measured. CWI did not have a significant effect on proprioception at the post-intervention but attenuated the reductions in Δ[HbO] in the primary sensory cortex and posterior parietal cortex (p < 0.05). The root mean square of vastus medialis was higher in the CWI compared to the CON. CWI effectively reduced core temperature and mean skin temperature and improved the rating of perceived exertion and thermal sensation. These results indicated that 10 min of CWI at 15 °C post-exercise had no negative effect on the neuromuscular control of the knee joint but could improve subjective perception and decrease body temperature.

Long-term outcomes of great saphenous vein harvest techniques for infrainguinal arterial bypass in a Medicare-matched registry database.

OBJECTIVE: Long-term outcomes for harvesting techniques for great saphenous vein (GSV) and its impact on the outcomes of infrainguinal arterial bypass remains largely unknown. Endoscopic GSV harvesting (EVH) has emerged as a less invasive alternative to conventional open techniques. Using the Vascular Quality initiative Vascular Implant Surveillance & Interventional Outcomes Network (VQI-VISION) database, we compared the long-term outcomes of infrainguinal arterial bypass using open and endoscopic GSV harvest techniques. METHODS: Patients who underwent infrainguinal GSV bypass between 2010 and 2019 were identified in the VQI-VISION Medicare linked database. Long-term outcomes of major/minor amputations, and reinterventions up to 5 years of follow-up were compared between continuous incisions, skip incision, and EVH, with continuous incisions being the reference group. Secondary outcomes included 30- and 90-day readmission, in addition to surgical site infections and patency rates at 6 months to 2 years postoperatively. Survival analysis using Kaplan-Meier curves and Cox regression hazard models were utilized to compare outcomes between groups. To adjust for multiple comparisons between the study groups, a P value of 2.5% was considered significant. RESULTS: Among the 8915 patients included in the study, continuous and skip vein harvest techniques were used in 44.4% and 43.4% of cases each, whereas 12.3% underwent EVH. The utilization of EVH remained relatively stable at around 12% throughout the study period. Compared with GSV harvest using continuous incisions, EVH was associated with higher rates of reintervention at 1 year (46.5% vs 41.3%; adjusted hazard ratio [aHR], 1.22; 95% confidence interval [CI], 1.06-1.41; P = .01]. However, no significant difference was observed between EVH and continuous incisions, and between skip and continuous incisions in terms of long-term reintervention or major and minor amputations on adjusted analysis. Compared with continuous incision vein harvest, both EVH and skip incisions were associated with lower surgical site infection rates within the first 6 months post-bypass (aHR, 0.53; 95% CI, 0.35-0.82 and aHR, 0.68; 95% CI, 0.53-0.87, respectively). Loss of primary, primary-assisted, and secondary patency was higher after EVH compared with continuous incision vein harvest. Among surgeons performing EVH, comparable long-term outcomes were observed regardless of low (<4 cases/year), medium (4-7 cases/year), or high procedural volumes (>7 cases/year). CONCLUSIONS: Despite higher 1-year reintervention rates, EVH for infrainguinal arterial bypass is not associated with a significant difference in long-term reintervention or amputation rates compared with other harvesting techniques. These outcomes are not influenced by procedural volumes for EVH technique.

Short-Term Out-of-Pocket and Total Costs of Care After Ablation, Resection, or Transplant for Early-Stage Hepatocellular Carcinoma: A National SEER-Medicare Cost Comparison.

Background: Differences in survival and morbidity among treatment options (ablation, surgical resection, and transplant) for early-stage hepatocellular carcinoma (HCC) have been well-studied. Additional understanding of the costs of such care would help to identify drivers of high costs and potential barriers to care delivery. Objective: To quantify total and patient out-of-pocket costs for ablation, surgical resection, and transplant in the management of early-stage HCC and to identify factors predictive of these costs. Methods: This retrospective U.S. population-based study used the SEER-Medicare linked dataset to identify a sample of 1067 Medicare beneficiaries (mean age, 73 years; 674 men, 393 women) diagnosed with early-stage HCC (size ≤5 cm) treated with ablation (N=623), resection (N=201), or transplant (N=243) between January 2009 and December 2016. Total costs and patient out-of-pocket costs for the index procedure as well as for any care within 30 days and 90 days post-procedure were identified and stratified by treatment modality. Additional comparisons were performed among propensity-score matched subgroups of patients treated by ablation or resection (each N=172). Multivariable linear regression models were used to identify factors predictive of total costs and out-of-pocket costs for index procedures as well as for 30-day and 90-day post-procedure periods. Results: For ablation, resection, and transplant, median index-procedure total cost was $6689, $25,614, and $66,034; index-procedure out-of-pocket cost was $1235, $1650, and $1317; 30-day total cost was $9456, $29,754, and $69,856; 30-day out-of-pocket cost was $1646, $2208, and $3198; 90-day total cost was $14,572, $34,984, and $88,103; and 90-day out-of-pocket cost was $2138, $2462, and $3876, respectively (all p<.001). In propensity-matched subgroups, ablation and resection had median index-procedure, 30-day, and 90-day total costs of $6690 and $25,716, $9995 and $30,365, and $15,851 and $34,455, respectively. In multivariable analysis adjusting for socioeconomic factors, comorbidities, and liver-disease prognostic indicators, surgical treatment (resection or transplant) was predictive of significantly greater costs compared with ablation at all time points. Conclusion: Total and out-of-pocket costs for index procedures as well as for 30-day and 90-day post-procedure periods were lowest for ablation, followed by resection and then transplant. Clinical Impact: This comprehensive cost analysis could help inform future cost-effectiveness analyses.

Short-term outcomes of heavyweight versus mediumweight synthetic mesh in a retrospective cohort of clean-contaminated and contaminated retromuscular ventral hernia repairs.

BACKGROUND: Mediumweight (40-60 g/m2) polypropylene (MWPP) mesh has been shown to be safe and effective in CDC class II-III retromuscular ventral hernia repairs (RMVHR). However, MWPP has the potential to fracture, and it is possible that heavyweight (> 75 g/m2) polypropylene mesh has similar outcomes in this context. However, there is limited data on HWPP mesh performance in clean-contaminated and contaminated scenarios. We aimed to compare HWPP to MWPP mesh in CDC class II-III wounds during open RMVHR. METHODS: The Abdominal Core Health Quality Collaborative database was retrospectively queried for a cohort of patients who underwent open RMVHR with MWPP or HWPP mesh placed in CDC class II/III wounds from 2012 to 2023. Mesh types were compared using a 3:1 propensity score-matched analysis. Covariates for matching included CDC classification, BMI, diabetes, smoking within 1 year, hernia, and mesh width. Primary outcome of interest included wound complications. Secondary outcomes included reoperations and readmissions at 30 days. RESULTS: A total of 1496 patients received MWPP or HWPP (1378 vs. 118, respectively) in contaminated RMVHR. After propensity score matching, 351 patients remained in the mediumweight and 117 in the heavyweight mesh group. There were no significant differences in surgical site infection (SSI) rates (13.4% vs. 14.5%, p = 0.877), including deep SSIs (0.3% vs. 0%, p = 1), surgical site occurrence rates (17.9% vs. 22.2%, p = 0.377), surgical site occurrence requiring procedural intervention (16% vs. 17.9%, p = 0.719), mesh removal (0.3% vs. 0%, p = 1), reoperations (4.6% vs. 2.6%, p = 0.428), or readmissions (12.3% vs. 9.4%, p = 0.504) at 30 days. CONCLUSION: HWPP mesh was not associated with increased wound morbidity, mesh excisions, reoperations, or readmissions in the early postoperative period compared with MWPP mesh in open RMVHR for CDC II/III cases. Longer follow-up will be necessary to determine if HWPP mesh may be a suitable alternative to MWPP mesh in contaminated scenarios.

Drain vs no drain placement after retromuscular ventral hernia repair with mesh: an ACHQC analysis.

INTRODUCTION: Ventral hernia repair (VHR) is one of the most common procedures in the United States, and drains are used in over 50% of mesh repairs. The aim of this study is to investigate the impact of drains on surgical site occurrences (SSO) and infection (SSI) after open and minimally invasive retromuscular VHR with mesh. METHODS: A retrospective review of prospectively collected data from the ACHQC was performed to include adult patients who underwent elective VHR with retromuscular mesh placement. Univariate analysis was performed comparing drain and no-drain groups. A logistic regression was performed to identify factors independently associated with increased SSO, SSI, readmission, and length of stay (LOS). RESULTS: 6945 patients underwent elective VHR with sublay mesh. Most patients had M2 and M3 hernias in both groups (with Drain and no-drain). The median LOS was 4.7 (SD 8.3) in the drain group and 1.6 (SD 8.4) in the no-drain group (p < 0.001). 30-day SSI was higher in the drain group (176; 3.8% vs 25; 1.1%; p < 0.001). Despite lower SSO overall in the drain group (470; 10.0% vs 286; 12.7%; p < 0.001), SSO or SSI requiring intervention (SSOPI) was higher in the drain group (240; 5.1% vs 44; 1.9%; p < 0.001). Logistic regression identified diabetes (OR 1.3, CI 1.1-1.6; p < 0.001) and BMI (OR 1.04, CI 1.03-1.05; p < 0.001) as predictors of SSO, while the use of a drain was protective (OR 0.61; CI 0.5-0.8; p < 0.001). For SSI, logistic regression showed diabetes (OR 1.6, CI 1.2-2.3; p = 0.004) and open approach (OR 3.5, CI 2.1-5.9; p < 0.001) as predictors. CONCLUSIONS: Drain placement during retromuscular VHR with mesh was predictive of decreased postoperative SSO occurrence but associated with increased LOS. Diabetes and open approach, but not drain use, were predictors of SSI.

Contemporary Assessment of Adhesiolysis and Resection for Adhesive Small Bowel Obstruction in the State of New York.

BACKGROUND: Adhesive small bowel obstruction (aSBO) is a common surgical problem, with some advocating for a more aggressive operative approach to avoid recurrence. Contemporary outcomes in a real-world setting were examined. STUDY DESIGN: A retrospective cohort study was performed using the New York Statewide Planning and Research Cooperative database to identify adults admitted with aSBO, 2016-2020. Patients were stratified by the presence of inflammatory bowel disease (IBD) and cancer history. Diagnoses usually requiring resection were excluded. Patients were categorized into four groups: non-operative, adhesiolysis, resection, and 'other' procedures. In-hospital mortality, major complications, and odds of undergoing resection were compared. RESULTS: 58,976 patients were included. 50,000 (84.8%) underwent non-operative management. Adhesiolysis was the most common procedure performed (n = 4,990, 8.46%), followed by resection (n = 3,078, 5.22%). In-hospital mortality in the lysis and resection groups was 2.2% and 5.9% respectively. Non-IBD patients undergoing operation on the day of admission required intestinal resection 29.9% of the time. Adjusted odds of resection were highest for those with a prior aSBO episode (OR 1.29 95%CI 1.11-1.49), delay to operation ≥3 days (OR1.78 95%CI 1.58-1.99), and non-New York City (NYC) residents being treated at NYC hospitals (OR1.57 95%CI 1.19-2.07). CONCLUSION: Adhesiolysis is currently the most common surgery for aSBO, however nearly one-third of patients will undergo a more extensive procedure, with an increased risk of mortality. Innovative therapies are needed to reduce the risk of resection.

Factors associated with 90-day reintervention following lower extremity revascularization.

OBJECTIVE: Peripheral artery disease (PAD) represents a high-volume, high-cost burden on the health care system. The Centers for Medicare and Medicaid Services has developed the Bundled Payments for Care Improvement-Advanced program, in which a single payment is provided for all services administered in a postsurgical 90-day episode of care. Factors associated with 30- and 90-day reinterventions after PAD interventions would represent useful data for both payors and stake holders. METHODS: We conducted a national cohort study of adults 65 years and older in the Vascular Quality Initiative and Centers for Medicare and Medicaid Services-linked dataset who underwent an open, endovascular, or hybrid revascularization procedure for PAD between January 1, 2010, and December 31, 2018. Procedures for acute limb ischemia and aneurysms were excluded. The primary outcome was 90-day reintervention. Reintervention at 30 days was a secondary outcome. Covariates of interest included demographics, comorbidities, and patient- and facility-level characteristics. Multivariable Cox regression was used to determine the association between patient- and facility-level characteristics and the risk of 30- and 90-day reinterventions. RESULTS: Among 42,429 patients (71.3% endovascular, 23.3% open, and 5.4% hybrid), median age was 74 years (interquartile range, 69-80 years), 57.9% were male, and 84.3% were White. Chronic limb-threatening ischemia was the operative indication in 40.4% of the procedures. Overall, 42.8% were completed in the outpatient setting (40.3% outpatient, 2.5% office-based lab). Over 70% of procedures for chronic limb-threatening ischemia were completed as inpatient, whereas 60% of the claudication interventions were done as outpatient. The 90-day reintervention rate was 14.5%, and the 30-day reintervention rate was 5.5%. Compared with inpatient procedures, PAD interventions completed in the outpatient or office-based lab setting had significantly higher 90- and 30-day reintervention rates (reference, inpatient; outpatient 90-day reintervention: hazard ratio [HR], 1.41; 95% confidence interval [CI] 1.25-1.60; outpatient 30-day reintervention: HR, 1.90; 95% CI, 1.62-2.24; office-based lab 90-day reintervention: HR, 2.09; 95% CI, 1.82-2.41; office-based lab 30-day reintervention: HR, 3.54; 95% CI, 3.17-3.94). Open and hybrid approaches demonstrated lower risk of reintervention compared with endovascular procedures at 30 and 90 days and, compared with aortoiliac disease, all other anatomic segments of disease were associated with higher 90-day reintervention, but no difference was noted at 30 days. CONCLUSIONS: Although outpatient PAD interventions may be convenient for patients and providers, the outpatient setting is associated with a significant risk of subsequent reintervention. Additional work is needed to understand how to improve the longevity of outpatient PAD interventions.

Long-term mesh-related complications from minimally invasive intraperitoneal onlay mesh for small to medium-sized ventral hernias.

INTRODUCTION: Intraperitoneal onlay mesh (IPOM) placement for small to medium-sized hernias has garnered negative attention due to perceived long-term risk of mesh-related complications. However, sparse data exists supporting such claims after minimally invasive (MIS) IPOM repairs and most is hindered by the lack of long-term follow-up. We sought to report long-term outcomes and mesh-related complications of MIS IPOM ventral hernia repairs. METHODS AND PROCEDURES: Adult patients who underwent MIS IPOM ventral hernia repair at our institution were identified in the Abdominal Core Health Quality Collaborative database from October 2013 to October 2020. Outcomes included hernia recurrence and mesh-related complications or reoperations up to 6 years postoperatively. RESULTS: A total of 325 patients were identified. The majority (97.2%) of cases were elective, non-recurrent (74.5%), and CDC class I (99.4%). Mean hernia width was 4.16 ± 3.86 cm. Median follow-up was 3.6 (IQR 2.8-5) years. Surgeon-entered or patient-reported follow-up was available for 253 (77.8%) patients at 3 years or greater postoperatively. One patient experienced an early small bowel obstruction and was reoperated on within 30 days. Two-hundred forty-five radiographic examinations were available up to 6 years postoperatively. Twenty-seven patients had hernia recurrence on radiographic examination up to 6 years postoperatively. During long-term follow-up, two mesh-related complications required reoperations: mesh removed for chronic pain and mesh removal at the time of colon surgery for perforated cancer. Sixteen additional patients required reoperation within 6 years for the following reasons: hernia recurrence (n = 5), unrelated intraabdominal pathology (n = 9), obstructed port site hernia (n = 1), and adhesive bowel obstruction unrelated to the prosthesis (n = 1). The rate of reoperation due to intraperitoneal mesh complications was 0.62% (2/325) with up to 6 year follow-up. CONCLUSION: Intraperitoneal mesh for repair of small to medium-sized hernias has an extremely low rate of long-term mesh-related complications. It remains a safe and durable option for hernia surgeons.

Comparison of endovascular therapies for chronic limb-threatening ischemia and claudication.

OBJECTIVE: Analysis of regional data from the Vascular Quality Initiative (VQI) suggested improved survival for patients undergoing stent placement compared with balloon angioplasty and atherectomy. Using national data from the VQI linked to Medicare claims data through the Vascular Implant Surveillance and Interventional Outcomes Network program, this study aimed to compare the rates of mortality, reintervention, and amputation after endovascular interventions (atherectomy, stenting, and balloon angioplasty) for two separate cohorts: patients with chronic limb-threatening ischemia (CLTI) and patients with claudication. METHODS: This was a secondary data analysis of Society for Vascular Surgery National VQI data linked to Medicare claims, between October 2016 and December 2019. Patients aged ≥65 years with symptoms of claudication or CLTI and a diagnosis of occlusive disease were included. Urgent or emergent interventions or those with concurrent procedures (endarterectomy, bypass, or bilateral intervention) were excluded. Interventions were grouped into (1) balloon angioplasty only; (2) stent (with or without balloon angioplasty); or (3) atherectomy (alone, with or without stent, with or without balloon angioplasty). Propensity score-matched cohorts were constructed to conduct pairwise intervention comparisons of mortality, reintervention, and amputation rates. Multivariable logistic regression was used to derive propensity scores for each patient. Kaplan-Meier estimates and Cox proportional hazards ratios (HRs) (95% confidence interval [CI]) analyses were performed. RESULTS: A total of 9785 (2665 claudication, 7120 CLTI) eligible patients were identified. After propensity score matching for the CLTI group, 2826, 3608, and 2796 pairs of cases were used to compare balloon angioplasty vs atherectomy, balloon angioplasty vs stent, and stent vs atherectomy, respectively. No statistically significant difference in mortality was observed among all interventions. However, atherectomy was associated with a significant increase in reintervention rate compared with balloon angioplasty (HR, 1.22; 95% CI, 1.06-1.39; P = .01) and compared with stenting (HR, 1.27; 95% CI, 1.10-1.46; P < .01) within the first year after the index procedure. Of note, both atherectomy (HR, 0.82; 95% CI, 0.68-0.98; P < .05) and stenting (HR, 0.76; 95% CI, 0.64-0.90; P < .01) showed lower rates of major amputation when compared with balloon angioplasty within 1 year after the index procedure. In the claudication group, there were no significant differences observed among interventions for peripheral arterial disease for mortality, reintervention, or amputation rates. CONCLUSIONS: Further studies are needed to identify appropriate indications for atherectomy, because there may be a subset of patients with CLTI who benefit from this therapy with respect to amputation rates. Until then, caution should be exercised when using atherectomy because it is also associated with higher reintervention rates.

Predictors for Early Liver Cancer Survival After Ablation and Surgical Resection: A Surveillance, Epidemiology, and End Results Program-Medicare Study.

OBJECTIVE: To identify independent predictors of all-cause and cancer-specific mortality after ablation or surgical resection (SR) for small hepatocellular carcinomas (HCCs), after adjusting for key confounders. METHODS: Using Surveillance, Epidemiology, and End Results Program-Medicare, HCCs less than 5 cm treated with ablation or SR in 2009 to 2016 (n = 956) were identified. Univariate and multivariable Cox regression models for all-cause and cancer-specific mortality were performed including demographics, clinical factors (tumor size, medical comorbidities, and liver disease factors), social determinants of health, and treatment characteristics. We also determined the most influential predictors of survival using a random forest analysis. RESULTS: Larger tumor size (3-5 cm) is predictive of all-cause (hazard ratio [HR] 1.31, P = .002) and cancer-specific mortality (HR 1.59, P < .001). Furthermore, chronic kidney disease is predictive of all-cause mortality (HR 1.43, P = .013), though it is not predictive of cancer-specific death. Multiple liver disease factors are predictive of all-cause and cancer-specific mortality including portal hypertension and esophageal varices (HRs > 1, P < .05). Though Asian race is protective in univariate models, in fully adjusted, multivariable models, Asian race is not a significant protective factor. Likewise, other social determinants of health are not significantly predictive of all-cause or cancer-specific mortality. Finally, treatment with SR, in later procedure years or at high-volume centers, is protective for all-cause and cancer-specific mortality. In machine learning models, year procedure was performed, ascites, portal hypertension, and treatment choice were the most influential factors. DISCUSSION: Treatment characteristics, liver disease factors, and tumor size are more important predictors of all-cause and cancer-specific death than social determinants of health for small HCCs.

Epidural analgesia and post-operative ileus after incisional hernia repair with transversus abdominis release: Results of a 5-year quality improvement initiative.

INTRODUCTION: The optimal pain management strategy after open ventral hernia repair (VHR) with transversus abdominus release (TAR) is unknown. Opioids are known to have an inhibitory effect on the GI tract and cause postoperative ileus. Epidural analgesia is associated with lower postoperative ileus rates but may contribute to other postoperative complications. A propensity-matched retrospective review published by our group in 2018 found that epidural analgesia was associated with an increased length of stay and any postoperative complication after VHR. Epidural analgesia was therefore abandoned by our group following this publication. We aimed to determine if discontinuation of epidural analgesia affected ileus rates after open VHR. METHODS: Patients who underwent open VHR with TAR from August 2014 to January 2022 â€‹at Cleveland Clinic Foundation with at least 30-day follow-up were retrospectively identified using the Abdominal Core Health Quality Collaborative registry. Patients with and without epidural analgesia were compared. The primary outcome was post-operative ileus. Additional outcomes included length of stay, deep venous thrombosis (DVT), pneumonia, wound complications and pain requiring intervention. RESULTS: A total of 2570 patients were included: 420 had an epidural, 2150 did not. Preoperative patient and hernia characteristics were similar between both groups. Mean hernia width was 15.5 â€‹cm in the epidural group and 16.1 â€‹cm in the no epidural group. In the epidural group, ileus was seen in 9 of 420 (2.15%) of patients which was significantly less than in the no epidural group, 400 of 2150 (18.6%), p=>0.001. On multivariate analysis, epidurals were predictive of lower risk of ileus (OR 0.04, 95%CI 0.01-0.17, p â€‹= â€‹0.001) and pain requiring intervention (OR 0.02, 95%CI 0.00-0.71, p â€‹= â€‹0.02). Epidural analgesia was not associated with increased DVT rates, pneumonia, length of stay, SSI, or SSOPI. DISCUSSION: Discontinuation of epidural analgesia was associated with a 9-fold increase in ileus rates after VHR with TAR. Epidurals may play an important role in limiting postoperative opioid use and therefore reducing risk of ileus. Other postoperative complications including pneumonia and venous thrombosis were not impacted by epidurals. Further prospective studies are needed to further define a ventral hernia patient population who will benefit from epidural analgesia.

Evaluating the impact of lifting mandatory smoking cessation prior to elective abdominal wall reconstruction. A single-center experience.

INTRODUCTION: Many studies identify active smoking as a significant risk factor for postoperative wound and mesh complications in patients undergoing abdominal wall reconstruction surgery. However, our group conducted an analysis using data from the ACHQC database, which revealed similar rates of surgical site infection (SSI) and surgical site occurrence requiring procedural intervention (SSOPI) between active smokers and non-smokers As a result, the Cl eveland Clinic Center for Abdominal Core Health instituted a policy change where active smokers were no longer subject to surgical delay. Our study aims to evaluate the impact of active smoking on the outcomes of these patients. METHODS: We identified active smoking patients who had undergone open, elective, clean ventral hernia repair (VHR) with transversus abdominis release (TAR) and permanent synthetic mesh at Cleveland Clinic Foundation. Propensity matching was performed to create a 1:3 ratio of "current-smokers" and "never-smokers" and compared wound complications and all 30-day morbidity between the two groups. RESULTS: 106 current-smokers and 304 never-smokers were matched. Demographics were similar between the two groups after matching, with the exception of chronic obstructive pulmonary disease (COPD) (22.1% vs. 13.4%, p â€‹< â€‹.001) and body mass index (BMI) (31.1 vs. 32.6, p â€‹= â€‹.02). Rates of SSI (12.2% vs. 6.9%, p â€‹= â€‹.13), SSO (21.7% vs. 13.2%, p â€‹= â€‹.052), SSOPI (11.3% vs. 6.3%, p â€‹= â€‹.13), and reoperation (1.9% vs. 3.9%, p â€‹= â€‹.53) were not significantly different between active smokers and never-smokers correspondingly. One case (0.3%) of partial mesh excision was observed in the never-smokers group (p â€‹= â€‹1). The current-smokers group exhibited a significantly higher incidence of pneumonia compared to the never-smokers group (5.7% vs. 0.7%, p â€‹= â€‹.005). CONCLUSION: Our study revealed that operating on active smokers did result in a slight increase in wound morbidity, although it did not reach statistical significance. Additionally, pulmonary complications were higher in the smoking group. Notably, we did not see any mesh infections in the smoking group during early follow up. We believe that this data is important for shared decision making on patients that are actively smoking contemplating elective hernia repair.

Open retromuscular keyhole compared with Sugarbaker mesh for parastomal hernia repair: Early results of a randomized clinical trial.

BACKGROUND: Open parastomal hernia repair can be performed using retromuscular synthetic mesh in a keyhole or Sugarbaker configuration. Relative morbidity and durability are unknown. Here, we present perioperative outcomes of a randomized controlled trial comparing these techniques, including 30-day patient-reported outcomes, reoperations, and wound complications in ≤90 days. METHODS: This single-center randomized clinical trial compared open parastomal hernia repair with retromuscular medium-weight polypropylene mesh in the keyhole and Sugarbaker configuration for permanent stomas between April 2019 and April 2022. Adult patients with parastomal hernias requiring open repair with sufficient bowel length for either technique were included. Patient-reported outcomes were collected at 30 days; 90-day outcomes included initial hospital length of stay, readmission, wound morbidity, reoperation, and mesh- or stoma-related complications. RESULTS: A total of 150 patients were randomized (75 keyhole and 75 Sugarbaker). There were no differences in length of stay, readmission, reoperation, recurrence, or wound complications. Twenty-four patients (16%) required procedural intervention for wound morbidity. Ten patients (6.7%) required abdominal reoperation in ≤90 days, 7 (4.7%) for wound morbidity, including 3 partial mesh excisions (1 keyhole compared with 2 Sugarbaker; P = 1). Four mesh-related stoma complications requiring reoperations occurred, including stoma necrosis (n = 1), bowel obstruction (n = 1), parastomal recurrence (n = 1), and mucocutaneous separation (n = 1), all in the Sugarbaker arm (P = .12). Patient-reported outcomes were similar between groups at 30 days. CONCLUSION: Open parastomal hernia repair with retromuscular mesh in the keyhole and Sugarbaker configurations had similar perioperative outcomes. Patients will be followed to determine long-term relative durability, which is critical to understanding each approach's risk-benefit ratio.

Association between readmission care fragmentation and outcomes after interventions for peripheral arterial disease.

OBJECTIVE: Lower extremity revascularization (LER) for peripheral artery disease is complicated by the frequent need for readmission. However, it is unclear if readmission to a nonindex LER facility (ie, a facility different from the one where the LER was performed) compared with the index LER facility is associated with worse outcomes. METHODS: This was a national cohort study of older adults who underwent open, endovascular, or hybrid LER for peripheral artery disease (January 1, 2010, to December 31, 2018) in the Vascular Quality Initiative who were readmitted within 90 days of their vascular procedure. This dataset was linked to Medicare claims and the American Hospital Association Annual Survey. The primary outcome was 90-day mortality and the secondary outcome was major amputation at 90 days after LER. The primary exposure was the location of the first readmission after LER (categorized as occurring at the index LER facility vs a nonindex LER facility). Generalized estimating equations logistic regression models were used to assess the association between readmission location and 90-day mortality and amputation. RESULTS: Among 42,429 patients who underwent LER, 33.0% were readmitted within 90 days. Of those who were readmitted, 27.3% were readmitted to a nonindex LER facility, and 42.2% of all readmissions were associated with procedure-related complications. Compared with patients readmitted to the index LER facility, those readmitted to a nonindex facility had a lower proportion of procedure-related reasons for readmission (21.5% vs 50.1%; P < .001). Most of the patients readmitted to a nonindex LER facility lived further than 31 miles from the index LER facility (39.2% vs 19.6%; P < .001) and were readmitted to a facility with a total bed size of <250 (60.1% vs 11.9%; P < .001). Readmission to a nonindex LER facility was not associated with 90-day mortality or 90-day amputation. However, readmission for a procedure-related complication was associated with major amputation (90-day amputation: adjusted odds ratio, 3.33; 95% confidence interval, 2.89-3.82). CONCLUSIONS: Readmission after LER for a procedure-related complication is associated with subsequent amputation. This finding suggests that quality improvement efforts should focus on understanding various types of procedure-related failure after LER and its role in limb salvage.

Beyond Survival: Adverse Events and Care Delivery Outcomes after Early Liver Cancer Treatment in a Nationally Representative Cohort.

PURPOSE: To compare secondary outcomes after ablation (AB), surgical resection (SR), and liver transplant (LT) for small hepatocellular carcinomas (HCCs), including resource utilization and adverse event (AE) rates. MATERIALS AND METHODS: Using Surveillance, Epidemiology, and End Results Program (SEER)-Medicare, HCCs <5 cm that were treated with AB, SR, or LT in 2009-2016 (n = 1,067) were identified using Healthcare Common Procedure Coding System codes through Medicare claims. Index procedure length of stay, need for intensive care unit (ICU) level care, readmission rates, and AE rates at 30 and 90 days were compared using chi-square tests or Fisher exact tests. Examined AEs included hemorrhage, abscess formation, biliary injury, pneumonia, sepsis, liver disease-related AEs, liver failure, and anesthesia-related AEs, identified by International Classification of Diseases, Ninth/10th Revision, codes. RESULTS: The median length of stay for initial treatment was 1 day, 6 days, and 7 days for AB, SR, and LT, respectively (P < .001). During initial hospital stay, 5.0%, 40.8%, and 63.4% of AB, SR, and LT cohorts, respectively, received ICU-level care (P < .001). By 30 and 90 days, there were significant differences among the AB, SR, and LT cohorts in the rate of postprocedural hemorrhage, abscess formation, biliary injury, pneumonia, sepsis, liver disease-related AEs, and anesthesia-related AEs (P < .05). By 90 days, the readmission rates after AB, SR, and LT were 18.6%, 28.2%, and 40.6% (P < .001), respectively. CONCLUSIONS: AB results in significantly less healthcare utilization during the initial 90 days after procedure compared with that after SR and LT due to shorter length of stay, lower intensity care, fewer readmissions, and fewer AEs.

Greater Patient Travel Distance is Associated with Perioperative and One-Year Cost Increases After Complex Aortic Surgery.

BACKGROUND: With increasing regionalization of complex aortic surgery within fewer US centers, patients may face increased travel burden when accessing aortic surgery. Longer travel distances have been associated with inferior outcomes after major surgery; however, the impacts of distance on reinterventions and costs have not been described. This study aims to assess the association between patient travel distance and longer-term outcomes including costs and reinterventions after complex aortic surgery. METHODS: A retrospective review was conducted of all patients in the Vascular Implant Surveillance and Interventional Outcomes Network database undergoing complex endovascular aortic repair including internal iliac or visceral vessel involvement, complex thoracic endovascular aortic repair including Zone 0-2 proximal extent or branched devices, and complex open abdominal aortic aneurysm repair including suprarenal or higher clamp sites. Travel distance was stratified by Rural-Urban Commuting Area population-density category. Multinomial logistic regression models, negative-binomial models, and zero-inflated Poisson models were used to assess the association between travel distance and index procedural and comprehensive first-year costs, long-term imaging, and long-term reinterventions, respectively. RESULTS: Between 2011 and 2018, 8,782 patients underwent complex aortic surgery in the Vascular Implant Surveillance and Interventional Outcomes Network database, including 4,822 complex endovascular aortic repairs, 2,672 complex thoracic endovascular aortic repairs, and 1,288 complex open abdominal aortic aneurysm repairs. Median travel distance was 22.8 miles (interquartile range 8.6-54.8 miles, range 0-2,688.9 miles). Median age was 75 years for all distance quintiles. Patients traveling farther were more likely to be female (26.8% in quintile 5 [Q5] vs. 19.9% in Q1, P < 0.001) and to have had a prior aortic surgery (20.8% for Q5 vs. 5.9% for Q1, P < 0.001). Patients traveling farther had higher index procedural costs, with adjusted odds ratio (OR) 2.34 (95% confidence interval [CI] 1.86-2.94, P < 0.0001) of being in the highest cost tertile versus lowest for patients in Q5 vs. Q1. For patients with ≥ 1-year follow-up, those traveling farther had higher imaging costs, with adjusted Q5 OR 1.55 (95% CI 1.22-1.95, P = 0.0002), and comprehensive first-year costs, with adjusted Q5 OR 2.06 (95% CI 1.57-2.70, P < 0.0001). In contrast, patients traveling farther had similar numbers of reinterventions and imaging studies postoperatively. CONCLUSIONS: Patients traveling farther for complex aortic surgery have higher procedural costs, postoperative imaging costs, and comprehensive first-year costs. These patients should be targeted for increased care coordination for improved outcomes and healthcare system burden.

Evidence-based objective performance criteria for the evaluation of hip and knee replacement devices and technologies.

BACKGROUND: Objective performance criteria (OPC) is a novel method to provide minimum performance standards and improve the regulated introduction of original or incremental device innovations in order to prevent patients from being exposed to potentially inferior designs whilst allowing timely access to improvements. We developed 2-year safety and effectiveness OPC for total hip and knee replacement (THR and TKR). METHODS: Analyses of large databases were conducted using various data sources: a systematic literature review; a direct data analysis from The Functional Outcomes Research for Comparative Effectiveness in Total Joint Replacement and Quality Improvement Registry (FORCE-TJR) and the Kaiser Permanente Implant Registry (KPIR); and claims data analyses from longitudinal discharge data in New York and California states. The literature review included U.S. patients (≥18 years) who received THR or TKR for primary end-stage osteoarthritis and prospectively collected data on patient-reported outcome measures (PROMs) from at least 100 subjects and/or 2-year implant survival for at least 250 implants. Random effects models were used for meta-analysis. RESULTS: Data were available from a total of 951 100 patients. After screening of 7979 abstracts, 294 studies underwent full-text review and 31 studies contributed to the evidence synthesis (333 995 implants). Direct data analysis of FORCE-TJR contributed 9223 joint replacement patients to the construction of OPC for effectiveness; KPIR contributed 262 044 patients for the construction of OPC for safety. Claims database analysis contributed 345 838 patients to the construction of safety OPC. OPC for safety were constructed for cumulative incidences of 2-year all-cause and septic revision (THR/TKR 2.0%/1.6% and 0.6%/0.7%), and OPC for effectiveness were constructed based on four disease-specific and three general health-related quality of life PROMs (HOOS/KOOS 87.1/80.6; HSS/KSS function 94.4/90.6; SF-12/SF-36, PCS 46.5/41.9, EQ-5D 0.88/0.84). CONCLUSION: This study is the first to construct a 2-year OPC for the safety and effectiveness of THR and TKR based on U.S. real-world data. Based on these OPC, potential benchmarks for (single-arm study) evaluation of new device innovations are suggested for a regulated and safe introduction to the (commercial) market.

Long-term Mortality and Reintervention After Repair of Ruptured Abdominal Aortic Aneurysms Using VQI-matched Medicare Claims.

OBJECTIVE: The objective of this study was to compare endovascular aortic aneurysm repair (EVAR) versus open aortic repair (OAR) on mortality and reintervention after ruptured infrarenal abdominal aortic aneurysm (rAAA) repair in the Vascular Quality Initiative (VQI). BACKGROUND: The optimal treatment modality for rAAA remains debated, with little data on long-term comparisons. METHODS: VQI rAAA repairs (2004-2018) were matched with Medicare claims (VQI-VISION). Primary outcomes were in-hospital and long-term mortality. Secondary outcome was reintervention. Inverse probability weighting was used to adjust for treatment selection, and Cox Proportional Hazards models and negative binomial regressions were used for analysis. Landmark analysis was performed among patients surviving hospital discharge. RESULTS: Among 1885 VQI/Medicare rAAA patients, 790 underwent OAR, and 1095 underwent EVAR. Median age was 76 years; 73% were male. Inverse probability weighting produced comparable groups. In-hospital mortality was lower after EVAR versus OAR (21% vs 37%, odds ratio: 0.52, 95% CI, 0.4-0.7). One-year mortality rates were lower for EVAR versus OAR [hazard ratio (HR) 0.74, 95% CI, 0.6-0.9], but not statistically different after 1 year (HR: 0.95, 95% CI, 0.8-1.2). This implies additional benefits to EVAR in the short term. Reintervention rates were higher after EVAR than OAR at 2 and 5 years (rate ratio: 1.79 95% CI, 1.2-2.7 and rate ratio:2.03 95% CI, 1.4-3.0), but not within the first year. Reintervention was associated with higher mortality risk for both OAR (HR: 1.66 95% CI, 1.1-2.5) and EVAR (HR: 2.14 95% CI, 1.6-2.9). Long-term mortality was similar between repair types (HR: 0.99, 95% CI, 0.8-1.2). CONCLUSIONS: Within VQI/Medicare patients undergoing rAAA repair, the perioperative mortality rate favors EVAR but equalizes after 1 year. Reinterventions were more common after EVAR and were associated with higher mortality regardless of treatment.