Clinical outcomes following an initial experience with a novel powered vascular stapler in video-assisted thoracoscopic lobectomies: results of a Chinese multi-center study.

BACKGROUND: The development of minimally invasive surgical approaches has revolutionized surgical care and greatly improved surgical outcomes. This study aimed to evaluate the clinical effectiveness of a powered vascular stapler (PVS) during video-assisted thoracoscopic surgery (VATS) lobectomy. METHODS: This prospective, multi-center, post-market clinical study in China enrolled 50 patients with either a suspected or formal diagnosis of clinical stage IA to IIB non-small cell lung cancer (NSCLC) scheduled for VATS lobectomy. The clinical effectiveness of the PVS for successful pulmonary artery (PA)/pulmonary vein (PV) transection was evaluated. In addition, the surgeon's stress, device usability, and surgeon satisfaction were measured using multiple questionnaires. RESULTS: A total of 167 PAs/PVs were transected with 3 (1.8%) requiring intra-operative intervention. Fourteen of the 50 patients (28.0%) experienced at least one adverse event (AE), among whom 5 (10.0%) suffered from serious AEs. There were no postoperative hemorrhagic complications related to transection of the PA/PV with PVS. Surgeon satisfaction was surveyed by questionnaire after each of the 50 procedures resulting in a 96% reported satisfaction with device usability, specifically related to a low stress load and an increase in work efficiency. CONCLUSIONS: For VATS lobectomy, the PVS demonstrated a positive surgical effectiveness and value in cognitive and physical distress reduction. Complications following VATS lobectomy to treat NSCLC were generally low and as expected. Intraoperative complications were few and there were no postoperative complications related to the transection of the PA and PV during VATS lobectomy. Favorable results were reported on the surgeon satisfaction questionnaire regarding usability and surgeon stress.

Initial Assessment of Mucosal Capture and Leak Pressure After Gastrointestinal Stapling in a Porcine Model.

BACKGROUND: Anastomotic leak is a leading cause of morbidity and mortality in gastrointestinal surgery. The serosal aspect of staple lines is commonly observed for integrity, but the mucosal surface and state of mucosa after firing is less often inspected. We sought to assess the degree of mucosal capture when using stapling devices and determine whether incomplete capture influences staple line integrity. METHODS: Porcine ileum was transected in vivo and staple lines were collected and rated for degree of mucosal capture on a 5-point scale from 1 (mucosa mainly captured on both sides) to 5 (majority of mucosa not captured). Mucosal capture was also assessed in ex vivo staple lines, and fluid leakage pressure and location of first leak was assessed. Stapling devices studied were Echelon Flex GST with 60-mm blue (GST60B) and green (GST60G) cartridges, and Medtronic EndoGIA Universal with Tri-Staple Technology™ with 60 mm medium (EGIA60AMT) reloads (purple). RESULTS: GST60B and GST60G staple lines produced significantly better mucosal capture scores than the EGIA60AMT staple lines (p < 0.001, in all tests). Compared to EGIA60AMT, leak pressures were 39% higher for GST60B (p < 0.001) and 23% higher for GST60G (p = 0.022). Initial staple line leak site was associated with incomplete mucosal capture 78% of the time. CONCLUSIONS: There are differences in degree of mucosal capture between commercial staplers, and the devices that produce better mucosal capture had significantly higher leak pressures. Further research is needed to determine the significance of these findings on staple line healing throughout the postoperative period.

A novel approach to glycemic control in type 2 diabetes mellitus, partial jejunal diversion: pre-clinical to clinical pathway.

OBJECTIVE: To explore partial jejunal diversion (PJD) via a side-to-side jejuno-jejunostomy for improved glycemic control in type 2 diabetes mellitus (T2DM). PJD is an anatomy-sparing, technically simple surgery in comparison to the predominate metabolic procedures, Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG). Positive results in a rodent model prompted a human proof-of-concept study. RESEARCH DESIGN AND METHODS: Pre-clinically, 71 rats were studied in a model of metabolic dysfunction induced by a high-fat diet; 33 animals undergoing one of two lengths of PJD were compared with 18 undergoing sham, 10 RYGB and 10 jejuno-ileal bypass. Clinically, 15 adult subjects with treated but inadequately controlled T2DM (hemoglobin A1c (HbA1c) of 8.0%-11.0%), body mass index of 27.0-40.0 kg/m2, and C peptide ≥3 ng/mL were studied. Follow-up was at 2 weeks, and 3, 6, 9, and 12 months post-PJD. RESULTS: Pre-clinically, positive impacts with PJD on glucose homeostasis, cholesterol, and body composition versus sham control were demonstrated. Clinically, PJD was performed successfully without serious complications. Twelve months post-surgery, the mean (SD) reduction from baseline in HbA1c was 2.3% (1.3) (p<0.01). CONCLUSIONS: PJD may provide an anatomy sparing, low-risk, intervention for poorly controlled T2DM without significant alteration of the patient's lifestyle. The proof-of-concept study is limited by a small sample size and advanced disease, with 80% of participants on insulin and a mean time since diagnosis of over 10 years. Further study is warranted. TRIAL REGISTRATION NUMBER: NCT02283632; Pre-results.

Comparison of economic and clinical outcomes between patients undergoing laparoscopic bariatric surgery with powered versus manual endoscopic surgical staplers.

AIMS: To compare economic and clinical outcomes between patients undergoing laparoscopic Roux-en-Y gastric bypass (LRY) or laparoscopic sleeve gastrectomy (LSG) with use of powered vs manual endoscopic surgical staplers. MATERIALS AND METHODS: Patients (aged ≥21 years) who underwent LRY or LSG during a hospital admission (January 1, 2012-September 30, 2015) were identified from the Premier Perspective Hospital Database. Use of powered vs manual staplers was identified from hospital administrative billing records. Multivariable analyses were used to compare the following outcomes between the powered and manual stapler groups, adjusting for patient and hospital characteristics and hospital-level clustering: hospital length of stay (LOS), total hospital costs, medical/surgical supply costs, room and board costs, operating room costs, operating room time, discharge status, bleeding/transfusion during the hospital admission, and 30, 60, and 90-day all-cause readmissions. RESULTS: The powered and manual stapler groups comprised 9,851 patients (mean age = 44.6 years; 79.3% female) and 21,558 patients (mean age = 45.0 years; 78.0% female), respectively. In the multivariable analyses, adjusted mean hospital LOS was 2.1 days for both the powered and manual stapler groups (p = .981). Adjusted mean total hospital costs ($12,415 vs $13,547, p = .003), adjusted mean supply costs ($4,629 vs $5,217, p = .011), and adjusted mean operating room costs ($4,126 vs $4,413, p = .009) were significantly lower in the powered vs manual stapler group. The adjusted rate of bleeding and/or transfusion during the hospital admission (2.46% vs 3.22%, p = .025) was significantly lower in the powered vs manual stapler group. The adjusted rates of 30, 60, and 90-day all-cause readmissions were similar between the groups (all p > .05). Sub-analysis by manufacturer showed similar results. LIMITATIONS: This observational study cannot establish causal linkages. CONCLUSIONS: In this analysis of patients who underwent LRY or LSG, the use of powered staplers was associated with better economic outcomes, and a lower rate of bleeding/transfusion vs manual staplers in the real-world setting.

The clinical and economic burden of significant bleeding during lung resection surgery: A retrospective matched cohort analysis of real-world data.

OBJECTIVES: The objective of this retrospective study was to quantify the clinical and economic burden of significant bleeding in lung resection surgery in the US. METHODS: This study utilized 2009-2012 data from the Premier Perspective DatabaseTM. Adult patients with primary pulmonary lobectomy or segmentectomy procedures were categorized by the surgical approach (VATS vs open) and primary diagnosis (primary or metastatic lung cancer vs non-lung cancer). Patients requiring ≥3 units of blood products with at least 1 unit of PRBCs: "significant bleeding" cohort; those requiring <3 units: "non-significant bleeding" cohort; and those not requiring blood products: "no bleeding" cohort. A matched cohort analysis was performed between the "significant bleeding" and the "no bleeding cohort" using matching variables: hospital, lung cancer diagnosis, year of surgery, APR-DRG severity score, procedure type and approach, age, and gender. RESULTS: The "All-patient" cohort comprised 21,429 patients: 213 "significant bleeding"; 2,780 "non-significant bleeding"; and 18,436 "no bleeding". Overall incidence of significant chest bleeding was 0.99%. Patients from "significant bleeding" cohort and "non-significant bleeding" cohort had 2.5 days and 2 days (p < 0.0001) longer length of stay in the hospital compared to those in the "no bleeding" cohort, respectively. Overall, hospital costs for "significant bleeding" cohort were higher than "no bleeding" cohort for those who were covered under Medicare ($59,871 vs $23,641), were ≥76 years of age ($64,010 vs $24,243), had greater severity of illness ($97,813 vs $51,871) and underwent open segmentectomy ($74,220 vs $21,903). Hospital costs for "significant bleeding" cohort and "non-significant bleeding" were significantly higher ($11,589 and $5,280, respectively, p < 0.0001) than no bleeding cohort. CONCLUSIONS: Although significant bleeding during lung resection surgery is rare, patients with such complication could stay longer at the hospital and cost an average of $13,103 more than those without.

A Narrative of Intraoperative Staple Line Leaks and Bleeds During Bariatric Surgery.

The primary objective of this review was to assess the incidence of intraoperative staple line leaks and bleeds during laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB). A literature search of MEDLINE®, EMBASE™, and Biosis from January 2010 to November 2014, plus secondary citations extending to 2008, identified 16 relevant articles. For LSG, the incidence of intraoperative leaks and bleeds was as high as 3.93 and 4.07 %, respectively. For LRYGB, leaks occurred in up to 8.26 % and bleeds in 3.45 % of cases. Stapler misfire was commonly cited as a cause. Widespread, precautionary use of staple line reinforcement (SLR), lack of standardized testing, and underreporting suggest the incidence may be underestimated. Published studies were insufficient to address the economic impact of bleeds and leaks or interventions, but development of improved stapler designs that obviate the need for SLR may reduce costs and improve outcomes.