A new bioabsorbable sleeve for lung staple-line reinforcement (FOREseal™): report of a three-center phase II clinical trial

Objective: To investigate on the feasibility, safety, and effectiveness of a new bioabsorbable material for lung staple-line reinforcement. Methods: This prospective open trial included 66 patients (mean age of 56 ± 17 years) who underwent various types of lung resection using staplers with knitted calcium alginate sleeves for buttressing (FOREseal™, Laboratoires Brothier, Nanterre, France) at three academic centers: 29 lobectomies, 22 emphysema surgeries, 15 wedge resections or lung biopsies. Intraoperative air leakage was assessed at a mean respiratory peak pressure of 30 cmH₂O, and rated as grade 1, 2, or 3. Persistent air leakage in the postoperative course, as well as any relevant event, was assessed daily. The follow-up period was of 6 months. Results: No technical problem linked to the device occurred. Hemostasis of the cutting edges was completed in all patients. Fifty-six percent of the patients had no intraoperative air leak and 27.3% had grade 1 leaks. Mean postoperative air leaks and thoracic drainage times were 1.9 ± 2.3 days and 6 ± 5.3 days, respectively. In-hospital mortality was nil. There was no empyema. Mean hospital stay was 9.1 ± 6.6 days. At follow-up, one patient underwent lung transplantation, and pathology of the explanted specimen showed the absence of device-related foreign-body inflammation. One patient complained from metalloptysis, and another one, with a metastatic invasive aspergillosis, developed an infectious recurrence that required reoperation. Conclusions: FOREseal is an ergonomic, safe, and promising new material instead of nonabsorbable materials and xenomaterials for staple-line reinforcement. A randomized comparative study is now in progress.     

Preoperative Risk Levels and Vascular Access in Transcatheter Aortic Valve Implantation—A Single‐Institute Analysis—

Although transcatheter aortic valve implantation (TAVI) has been indicated for patients with high surgical risk, indications for or against the procedure become more difficult as vascular access becomes more proximal and/or invasive in order to accommodate patients with even higher risks. We compared preoperative factors including the European System for Cardiac Operative Risk Evaluation (EuroSCORE) and Society of Thoracic Surgeons Predicted Risk of Mortality (STS) score with postoperative survival in 195 patients undergoing TAVI during 2.5 years (January 2010 to June 2012), when vascular access routes were developed from iliofemoral (IL/Fm access, n = 149), axillo‐clavicular, apical, and direct aortic approaches (alternative access, n = 46). Logistic regression analyses showed that alternative access was associated with reduced 30‐day survival (P = 0.024), while high surgical risk (>15% in both EuroSCORE and STS score) was associated with reduced 1‐year survival (P = 0.046). Thus, patients treated via IL/Fm access had acceptable outcome regardless of preoperative risk levels while patients with low surgical risk (<15%) had favorable outcome irrespective of access route. Since the remaining patients with combined risk factors, high preoperative risk level (>15%) requiring alternative access, had a prohibitive risk in our experience, they might have been considered untreatable or not amenable even to TAVI and offered medical or alternative managements.     

Pancreatic β-cell dysfunction in type 2 diabetes: Implications of inflammation and oxidative stress

Insulin resistance and pancreatic β-cell dysfunction are major pathological mechanisms implicated in the development and progression of type 2 diabetes(T2D). Beyond the detrimental effects of insulin resistance, inflammation and oxidative stress have emerged as critical features of T2D that define β-cell dysfunction. Predominant markers of inflammation such as C-reactive protein, tumor necrosis factor alpha, and interleukin-1β are consistently associated with β-cell failure in preclinical models...     

Radiotherapy for benign disease; assessing the risk of radiation-induced cancer following exposure to intermediate dose radiation

Most radiotherapy (RT) involves the use of high doses (>50 Gy) to treat malignant disease. However, low to intermediate doses (approximately 3–50 Gy) can provide effective control of a number of benign conditions, ranging from inflammatory/proliferative disorders (e.g. Dupuytren''s disease, heterotopic ossification, keloid scarring, pigmented villonodular synovitis) to benign tumours (e.g. glomus tumours or juvenile nasopharyngeal angiofibromas). Current use in UK RT departments is very variable. This review identifies those benign diseases for which RT provides good control of symptoms with, for the most part, minimal side effects. However, exposure to radiation has the potential to cause a radiation-induced cancer (RIC) many years after treatment. The evidence for the magnitude of this risk comes from many disparate sources and is constrained by the small number of long-term studies in relevant clinical cohorts. This review considers the types of evidence available, i.e. theoretical models, phantom studies, epidemiological studies, long-term follow-up of cancer patients and those treated for benign disease, although many of the latter data pertain to treatments that are no longer used. Informative studies are summarized and considered in relation to the potential for development of a RIC in a range of key tissues (skin, brain etc.). Overall, the evidence suggests that the risks of cancer following RT for benign disease for currently advised protocols are small, especially in older patients. However, the balance of risk vs benefit needs to be considered in younger adults and especially if RT is being considered in adolescents or children.     

Pure ‘natural orifice transluminal endoscopic surgery’ for transvaginal nephrectomy in the porcine model

OBJECTIVES

To determine the technical feasibility and reproducibility of pure natural orifice transluminal endoscopic surgery (NOTES) transvaginal nephrectomy using NOTES‐specific instrumentation, with no transabdominal assistance.

MATERIALS AND METHODS

Five female farm pigs (mean weight 45 kg) had a right NOTES nephrectomy, using a single‐channel gastroscope in the first three pigs and a dual‐channel gastroscope in the remaining two. The peritoneal cavity was accessed through the posterior fornix of the vagina. Dissection was started at the lower pole of the kidney, and the ureter was retracted laterally and followed towards the hilum. An XL articulated 60 cm endo‐GIA stapler (US Surgical, Norwalk, CO, USA), inserted transvaginally via a separate vaginal incision, was used for tissue retraction and renal hilar transection. The kidney was freed, entrapped in an impermeable sac, and extracted intact transvaginally.

RESULTS

All five procedures were successful with no addition of a transabdominal laparoscopic port or open conversion. The total operative duration decreased from 200 min in the first pig to 60 min in the last (mean 113 min); the mean blood loss was <50 mL, the mean kidney length was 13.9 cm and the weight was 142 g. There were no intraoperative complications; at autopsy, there was no pelvic or bowel injury.

CONCLUSIONS

Pure NOTES transvaginal nephrectomy is feasible in the porcine model. It has the potential of a less morbid approach, providing truly scar‐less surgery. Further development of instrumentation is necessary.     

Case Report—Complex Management of a Postoperative Bronchogastric Fistula After Laparoscopic Sleeve Gastrectomy

Laparoscopic sleeve gastrectomy (LSG) is a new restrictive bariatric procedure increasingly indicated in the treatment of morbid obesity. Postoperative complications are mainly represented by gastric fistula with an occurrence rate of 0% to 5.1% in the literature. This complication is difficult to manage and requires multiple radiological, endoscopic, and surgical procedures. We report herein the case of a 23-year-old woman who underwent LSG for morbid obesity. This patient was reoperated for peritonitis due to a gastric fistula located on the top of the staple line. Five months later, she complained of a cough with fever and expectoration. A methylene blue test and a computed tomography scan diagnosed a postoperative bronchogastric fistula. After failure of aggressive conservative management, radical surgery was performed with total gastrectomy, reconstruction of the diaphragm using the extended latissimus dorsi flap, and a pulmonary lobectomy. This case report highlights the possible issue of the complex management of gastric fistula after LSG.     

Associations of serum EBV DNA and gammopathy with post-transplant lymphoproliferative disease

Abstract: Background: Post‐transplant lymphoproliferative disease (PTLD) is a life‐threatening complication of immunosuppression following transplantation. Epstein–Barr virus (EBV) and gammopathy in serum are associated with PTLD, but these two parameters have not been evaluated in parallel for their association with PTLD. Methods: We evaluated the incidence of EBV load positivity, gammopathy, and protein expression in sera from all PTLD patients diagnosed at our hospital during the past seven yr. Results were compared with those of a control group including matched transplanted patients who did not develop PTLD. Results: Seven of 10 PTLD patients presented EBV⁺ PTLD, for which five patients had detectable serum EBV DNA levels compared with none of 38 controls (RR between two groups =121, p < 0.0001). Five out of 10 patients had gammopathy at PTLD diagnosis compared with 5/38 controls (RR between two groups = 6.6, p = 0.022). Additionally, protein serum analysis by high‐resolution two‐dimensional gel electrophoresis and image examination failed to evidence specific abnormality in patients with PTLD compared with controls. Conclusions: Our results confirm an association between EBV in sera and gammopathy with PTLD, and highlight the high specificity of the former analysis. Whether a combination of both analyses will improve the clinical detection of PTLD remains to be evaluated in a larger prospective cohort study.