Global Surgeon Opinion on the Impact of Surgical Access When Using Endocutters Across Specialties.

Background: Despite design enhancements in endocutters, key challenges related to limited surgical access and space can impact stapling and, potentially, surgical outcomes. Objectives: This study aimed to develop consensus statements outlining the clinical value of precise articulation and greater anatomical access in minimally invasive surgery performed by bariatric, colorectal, and thoracic surgeons. Methods: Colorectal, bariatric, and thoracic surgeons from Japan, the United States, United Kingdom, and France participated in a 2-round modified Delphi panel. Round 1 included binary, Likert scale-type, multiple-response, and open-ended questions. These were converted to affirmative statements for round 2 if sufficient agreement was reached. Consensus was set at a predefined threshold of at least 90% of panelists across all surgical specialties and regions selecting the same option ("agree" or "disagree") for the affirmative statements. Results: Of the 49 statements in the round 2 questionnaire, panelists (n=135) reached consensus that (1) tissue slippage outside stapler jaws can occur due to limited access and space; (2) greater jaw aperture could help to manipulate thick or fragile tissue more easily; (3) articulation of an endocutter is clinically important in laparoscopic surgeries; (4) improved access to hard-to-reach targets and in limited space would improve safety; and (5) an endocutter with improved access through greater articulation would become common use. Discussion: By understanding user-specific challenges and needs from both specialty- and region-wide perspectives, endoscopic stapling devices can continue to be refined. In this study, improved articulation and greater jaw aperture were the key design features examined. Improved articulation and greater jaw aperture were key stapler design features identified in this study that may mitigate the risk of instrument clashes and intraoperative complications such as anastomotic leaks. Conclusions: This study gained insights into surgeons' perspective across a variety of specialties and from 3 distinct geographies. Participating surgeons reached consensus that an endocutter with greater jaw aperture and articulation may improve surgical access and has potential to improve surgical outcomes.

Cost-Effectiveness of Bariatric Surgery in Tunisia.

Purpose: Obesity is a growing global issue with evidence linking it to an increase in loss of disease-free years, reduced quality of life, increased mortality, and additional economic burden. This study sought to establish the cost-effectiveness of gastric bypass and sleeve gastrectomy, compared to conventional therapy in patients with obesity, from a Tunisian healthcare payor perspective. Patients and Methods: A Markov model compared lifetime costs and outcomes of bariatric surgery with conventional treatment among patients with body mass index (BMI) ≥ 40 kg/m2, BMI ≥ 35 kg/m2 with obesity-related co-morbidities (Group 1), or BMI ≥ 35 kg/m2 with type 2 diabetes mellitus (T2DM) (Group 2). Inputs were sourced from the Tunisian Health Examination Survey, local clinician data and literature sources. Health states were associated with different cost and utility decrements. Changes in body mass index, systolic blood pressure, lipid ratio and diabetes remission rates were modelled on a yearly basis. The incremental cost-effectiveness ratio (ICER), quality-adjusted life years (QALYs) and net monetary benefit (NMB) were key outcomes. Sensitivity and scenario analyses were performed to test the model's robustness. Results: The model showed that the benefits of bariatric surgery were favorable compared to conventional treatment, with an ICER of 1844 TND/QALY in Group 1 patients and 2413 TND/QALY in Group 2 patients. Bariatric surgery resulted in a QALY gain of 3.26 per patient in Group 1 and a gain of 1.77 per patient in Group 2. At a willingness to pay threshold of 31,379 TND/QALY, the incremental NMB was 96,251 TND and 51,123 TND for Group 1 and Group 2, respectively. Conclusion: From the Tunisian healthcare payor perspective, bariatric surgery is cost-effective for patients with obesity and those with T2DM and obesity-related comorbidities. These findings may have impact on future decision-making on funding and reimbursement of bariatric surgery in Tunisia.

Adopting a portfolio of ultrasonic and advanced bipolar electrosurgery devices from a single manufacturer compared to currently used ultrasonic and advanced bipolar devices: a probabilistic budget impact analysis from a Spanish hospital perspective.

AIMS: Advanced energy devices are commonly used in electrosurgery, including ultrasonic and advanced bipolar (ABP) devices. Smoke evacuation and reusable dispersive electrodes are also utilized during electrosurgery to improve staff and patient safety. This study assessed the budget impact of adopting a portfolio of Ethicon energy devices compared to devices from other manufacturers from a Spanish hospital perspective. METHODS: The main analysis compared the Ethicon advanced energy device portfolio (ultrasonic and ABP devices) to Non-Ethicon advanced energy devices. It was assumed that 4,000 procedures using one advanced energy device each were performed annually, and the cost impact of operating room time, length of stay, and transfusions were considered. A probabilistic budget impact analysis with 10,000 iterations was conducted for generalizability to other hospitals in Spain and Europe. Secondary analysis assessed whether cost savings from the Ethicon advanced energy device portfolio could offset costs of adopting smoke evacuation and reusable dispersive electrodes (Full Ethicon energy portfolio). RESULTS: In the main analysis, the annual budget impact of introducing the Ethicon advanced energy device portfolio was cost saving in 79.8% of probabilistic iterations (mean: -€945,214; 95% credible interval [CrI]: -€3,242,710; €1,285,942) with a mean budget impact per procedure of -€236 (95% CrI: -€811; €321). In the secondary analysis, adding smoke evacuation and reusable dispersive electrodes was still cost saving in 75.3% of iterations compared to Non-Ethicon advanced energy devices (mean: -€778,208; 95% CrI: -€3,075,086; €1,464,728) with a mean budget impact per procedure of -€97 (95% CrI: -€384; €183). Savings resulted from differences in operating room time, length of hospital stay, and volume of disposable electrodes. CONCLUSIONS: Adopting Ethicon advanced energy devices demonstrated economic benefits compared to non-Ethicon devices. Introducing the advanced portfolio may improve surgical care quality and the full portfolio was cost saving while improving OR safety for staff and patients.

This study created an economic model to calculate whether using modern electrical surgical tools with features to make cutting tissue and stopping bleeding faster and easier could save Spanish hospitals money. The electrical surgery tools from one manufacturer were compared to those from various other companies. Differences in how long surgery took to perform, how long patients stayed in hospital after their surgery, and how many blood transfusions they needed were considered in the model. The model was tested 10,000 times with random changes in the costs and settings used to be surer about the range of possible results. The results showed the devices from one manufacturer could save a Spanish hospital money in almost 80% of model runs and that savings worked out to €236 per surgery. In another analysis, savings were enough to cover the cost of introducing safety devices to remove surgical smoke from the operating room and reusable patient grounding electrodes that prevent some injuries potentially caused by small sticky electrodes. In conclusion, the model showed that Spanish hospitals may be able to save money by switching to the modern electrical surgery tools from Ethicon.

Budget impact analysis of HARMONIC FOCUS™+ Shears for mastectomy and breast-conserving surgery with axillary lymph node dissection compared with monopolar electrocautery from an Italian hospital perspective.

BACKGROUND: Mastectomy or breast conserving surgery, both with axillary lymph node dissection, are common treatments for early-stage breast cancer. Monopolar electrocautery is typically used for both procedures, despite evidence of improved clinical outcomes with HARMONIC FOCUS™+. This analysis evaluated the budget impact of adopting HARMONIC FOCUS™+ versus monopolar electrocautery for patients undergoing these procedures from an Italian hospital perspective. METHODS: Total costs for an annual caseload of 100 patients undergoing mastectomy or breast conserving surgery, with axillary lymph node dissection, with either the intervention or comparator were calculated. Italian clinical and cost input data were utilised. The analysis included costs for the device, operating room time, postoperative length of stay, treating seroma and managing postoperative chest wall drainage. Deterministic and probabilistic sensitivity analyses assessed uncertainty of model input values. Two scenario analyses investigated the impact of conservative estimates of postoperative length of stay reduction and daily hospital cost on the simulated cost difference. RESULTS: HARMONIC FOCUS™+ achieves annual savings of EUR 100,043 compared with monopolar electrocautery, derived from lower costs for operating room time, postoperative length of stay and seroma and postoperative chest wall drainage management, offsetting the incremental device cost increase (EUR 43,268). Cost savings are maintained in scenario analyses and across all variations in parameters in deterministic sensitivity analysis, with postoperative hospital stay costs being key drivers of budget impact. The mean (interquartile range) cost savings with HARMONIC FOCUS™+ versus monopolar electrocautery in probabilistic sensitivity analysis are EUR 101,637 (EUR 64,390-137,093) with a 98% probability of being cost saving. CONCLUSIONS: The intervention demonstrates robust cost savings compared with monopolar electrocautery for mastectomy or breast conserving surgery, with axillary lymph node dissection, in an Italian hospital setting, and improved clinical and resource outcomes. These findings, with other clinical and cost analyses, support HARMONIC FOCUS™+ use in this setting.

Association of In-Hospital Surgical Bleeding Events with Prolonged Hospital Length of Stay, Days Spent in Critical Care, Complications, and Mortality: A Retrospective Cohort Study Among Patients Undergoing Neoplasm-Directed Surgeries in English Hospitals.

PURPOSE: To evaluate the association of in-hospital surgical bleeding events with the outcomes of hospital length of stay (LOS), days spent in critical care, complications, and mortality among patients undergoing neoplasm-directed surgeries in English hospitals. PATIENTS AND METHODS: This is a retrospective cohort study using English hospital discharge data (Hospital Episode Statistics [HES]) linked to electronic health records (Clinical Practice Research Datalink [CPRD]). HES includes information on patient demographics, admission and discharge dates, diagnoses and procedures, days spent in critical care, and discharge status. CPRD includes information on patient demographics, diagnoses and symptoms, drug exposures, vaccination history, and laboratory tests. Patients aged ≥18 years who underwent selected neoplasm-directed surgeries between 1-Jan-2010 and 29-February-2016: hysterectomy, low anterior resection (LAR), lung resection, mastectomy, and prostate surgery were included. The primary independent variable was in-hospital surgical bleeding events identified by diagnosis of haemorrhage and haematoma complicating a procedure or reopening/re-exploration and surgical arrest of postoperative bleeding. Outcomes included LOS, days spent in critical care, in-hospital complications (diagnoses of infections, acute renal failure, vascular events), and in-hospital mortality, identified during surgery through discharge. Multivariable regression was used to examine the adjusted association of bleeding events with outcomes. RESULTS: The study included 26,437 neoplasm-directed surgeries (hysterectomy=6092; LAR=2957; lung=1538; mastectomy=12,806; prostate=3044). Incidence proportions of bleeding events were: hysterectomy=1.9% (95% confidence interval=1.1-2.5%); LAR=3.0% (CI=2.3-3.6%); lung=1.8% (CI=1.1-2.5%); mastectomy=1.6% (CI=1.3-1.8%); prostate=1.0% (CI=0.6-1.3%). In adjusted analyses, bleeding events were associated with: prolonged LOS: 3.1 (CI=1.1-6.3) mastectomy to 5.7 (CI=3.6-8.2) LAR days longer; more days spent in critical care: 0.4 (CI=0.03-0.27) mastectomy to 6.5 (CI=2.5-13.6) hysterectomy days more; and higher incidence proportions of all examined complications; all P<0.05. CONCLUSION: This study quantifies a substantial clinical and healthcare resource utilization burden associated with surgical bleeding among patients undergoing neoplasm-directed surgery in England hospitals.

Impact of bleeding complications on length of stay and critical care utilization in cardiac surgery patients in England.

BACKGROUND: Bleeding is a significant complication in cardiac surgery and is associated with substantial morbidity and mortality. This study evaluated the impact of bleeding on length of stay (LOS) and critical care utilization in a nationwide sample of cardiac surgery patients treated at English hospitals. METHODS: Retrospective, observational cohort study using linked English Hospital Episode Statistics (HES) and Clinical Practice Research Datalink (CPRD) records for a nationwide sample of patients aged ≥18 years who underwent coronary artery bypass graft (CABG), valve repair/replacement, or aortic operations from January 2010 through February 2016. The primary independent variables were in-hospital bleeding complications and reoperation for bleeding before discharge. Generalized linear models were used to quantify the adjusted mean incremental difference [MID] in post-procedure LOS and critical care days associated with bleeding complications, independent of measured baseline characteristics. RESULTS: The study included 7774 cardiac surgery patients (3963 CABG; 2363 valve replacement/repair; 160 aortic procedures; 1288 multiple procedures, primarily CABG+valve). Mean LOS was 10.7d, including a mean of 4.2d in critical care. Incidences of in-hospital bleeding complications and reoperation for bleeding were 6.7 and 0.3%, respectively. Patients with bleeding had longer LOS (MID: 3.1d; p < 0.0001) and spent more days in critical care (MID: 2.4d; p < 0.0001). Reoperation for bleeding was associated with larger increases in LOS (MID = 4.0d; p = 0.002) and days in critical care (MID = 3.2d; p = 0.001). CONCLUSIONS: Among English cardiac surgery patients, in-hospital bleeding complications were associated with substantial increases in healthcare utilization. Increased use of evidence-based strategies to prevent and manage bleeding may reduce the clinical and economic burden associated with bleeding complications in cardiac surgery.

A hospital cost analysis of a fibrin sealant patch in soft tissue and hepatic surgical bleeding.

BACKGROUND: Despite hemostat use, uncontrolled surgical bleeding is prevalent. Drawbacks of current hemostats include limitations with efficacy on first attempt and suboptimal ease-of-use. Evarrest® is a novel fibrin sealant patch that has demonstrated high hemostatic efficacy compared with standard of care across bleeding severities. The objective of this study was to conduct a hospital cost analysis of the fibrin sealant patch versus standard of care in soft tissue and hepatic surgical bleeding. METHODS: The analysis quantified the 30-day costs of each comparator from a hospital perspective. Published US unit costs were applied to resource use (ie, initial treatment, retreatment, operating time, hospitalization, transfusion, and ventilator) reported in four trials. A "surgical" analysis included resources clinically related to the hemostatic benefit of the fibrin sealant patch, whereas a "hospital" analysis included all resources reported in the trials. An exploratory subgroup analysis focused solely on coagulopathic patients defined by abnormal blood test results. RESULTS: The surgical analysis predicted cost savings of $54 per patient with the fibrin sealant patch compared with standard of care (net cost impact: -$54 per patient; sensitivity range: -$1,320 to $1,213). The hospital analysis predicted further cost savings with the fibrin sealant patch (net cost impact of -$2,846 per patient; sensitivity range: -$1,483 to -$5,575). Subgroup analyses suggest that the fibrin sealant patch may provide dramatic cost savings in the coagulopathic subgroup of $3,233 (surgical) and $9,287 (hospital) per patient. Results were most sensitive to operating time and product units. CONCLUSION: In soft tissue and hepatic problematic surgical bleeding, the fibrin sealant patch may result in important hospital cost savings.