A Study Examining the Complications Associated with Gastric Banding

Background

Gastric banding is a well-recognized and common method of weight reduction surgery. Between November 2001 and September 2011, 1,100 laparoscopic adjustable gastric banding operations were performed in Sheffield. This study examines the long-term complication rate.

Methods

All available medical notes for patients undergoing gastric banding by one surgeon were reviewed. Data were available for 1,079 patients.

Results

A total of 932 females and 147 males underwent gastric banding. Mean weight was 120 kg, with body mass index of 43.3. Complications occurred in 347 patients (32.1 %). One hundred three (13.2 %) patients experienced band slippage; re-operation was required in half of these cases. Eighty-two patients had their band removed due to complications; there was slippage in 60, erosion in 17, and band intolerance in 5. One hundred thirty-six (12.6 %) patients experienced problems with their port or port tubing. Thirty-seven ports were flipped, noted during clinical or radiological fills (3.4 %), and 17 patients experienced port infection (1.5 %). Fifty ports required repositioning (4.6 %); 16 (1.4 %) were removed or replaced including five for cutaneous erosion. Eleven patients experienced tubing problems. Four patients required procedures to deal with intraoperative complications. Eighteen patients had a concurrent procedure. One postoperative death was due to biliary peritonitis in a patient who had undergone simultaneous cholecystectomy.

Conclusion

Complication rates reflect those in the literature. Slippage rate may appear higher in our patients, but this is a reflection of the fact that most patients undergo radiological band fills; hence, many non-symptomatic slippages are detected. Only half of our slippages (6.6 % of all patients) were clinically apparent or needed any intervention.     

Lenalidomide before and after autologous stem cell transplantation for transplant-eligible patients of all ages in the randomized,phase III,Myeloma XI trial

The optimal way to use immunomodulatory drugs as components of induction and maintenance therapy for multiple myeloma is unresolved. We addressed this question in a large phase III randomized trial, Myeloma XI. Patients with newly diagnosed multiple myeloma (n=2,042) were randomized to induction therapy with cyclophosphamide, thalidomide, and dexamethasone (CTD) or cyclophosphamide, lenalidomide, and dexamethasone (CRD). Additional intensification therapy with cyclophosphamide, bortezomib, and dexamethasone (CVD) was administered before autologous stem-cell transplantation to patients with a suboptimal response to induction therapy using a response-adapted approach. After receiving high-dose melphalan with autologous stem cell transplantation, eligible patients were further randomized to receive either lenalidomide alone or observation alone. Co-primary endpoints were progression-free survival (PFS) and overall survival (OS). The CRD regimen was associated with significantly longer PFS (median: 36 vs. 33 months; hazard ratio [HR], 0.85; 95% confidence interval [CI]: 0.75-0.96; P=0.0116) and OS (3-year OS: 82.9% vs. 77.0%; HR, 0.77; 95% CI: 0.63-0.93; P=0.0072) compared with CTD. The PFS and OS results favored CRD over CTD across all subgroups, including patients with International Staging System stage III disease (HR for PFS, 0.73; 95% CI: 0.58-0.93; HR for OS, 0.78; 95% CI: 0.56-1.09), high-risk cytogenetics (HR for PFS, 0.60; 95% CI: 0.43-0.84; HR for OS, 0.70; 95% CI: 0.42-1.15) and ultra-high-risk cytogenetics (HR for PFS, 0.67; 95% CI: 0.41-1.11; HR for OS, 0.65; 95% CI: 0.34-1.25). Among patients randomized to lenalidomide maintenance (n=451) or observation (n=377), maintenance therapy improved PFS (median: 50 vs. 28 months; HR, 0.47; 95% CI: 0.37-0.60; P<0.0001). Optimal results for PFS and OS were achieved in the patients who received CRD induction and lenalidomide maintenance. The trial was registered with the EU Clinical Trials Register (EudraCT 2009-010956-93) and ISRCTN49407852.     

A case–control study of fractures in men with idiopathic osteoporosis: Fractures are associated with older age and low cortical bone density

ObjectivesTo determine biochemical, radiological and micro-architectural bone factors related to fragility fractures in idiopathic male osteoporosis (IMO) patients. IMO is a rare disorder characterized by low areal bone mineral density (aBMD) (Z-score < ? 2) occurring in men after excluding secondary causes of low BMD.MethodsWe conducted a case–control study in 31 patients with fragility fracture (IMO F +) that had occurred after the age of 40 years and 37 without fracture (IMO F–). We first compared IMO group to 40 age-matched disease-free men. We measured aBMD and bone micro-architectural indices at distal radius and tibia sites with a HR-pQCT scan (XtremeCT) using standard and extended cortical analysis. Urine and blood samples were collected in order to determine the levels of bone-turnover markers and the potential determinant of bone fragility. Models of analysis of covariance, including age, height and weight as adjustment factors, were used to compare the groups.ResultsCompared to their controls, IMO patients showed marked disturbance of their micro‐architectural parameters at tibia and radius affecting both trabecular and cortical parameters. IMO F + subjects were significantly older than IMO F ? subjects (58 ± 8 vs. 53 ± 9 yrs, p = 0.01). BMD Z-score at the total-hip was significantly lower in IMO F + (? 1.3 ± 0.5 vs. ? 0.9 ± 0.8 g/cm², p = 0.01). After adjustment, trabecular micro‐architectural parameters, biochemical markers and hormonal parameters were not different in the 2 groups. At distal tibia, cortical v-BMD was significantly lower in IMO F + patients (799 ± 73 vs. 858 ± 60 mg/cm³, p = 0.03), while cortical thickness was not different.ConclusionOur results show that patients with IMO display a marked disturbance of trabecular and cortical bone micro-architecture, and that age and low cortical density are determinants of the fracture occurrence.     

Platelet reactivity evaluated with the VASP assay following ticagrelor loading dose in acute coronary syndrome patients undergoing percutaneous coronary intervention

Background

The level of platelet reactivity (PR) inhibition obtained after P2Y12-ADP receptor antagonist loading dose (LD) is associated with the ischemic and bleeding risk following percutaneous coronary intervention (PCI) in acute coronary syndromes (ACS).

Objective

We aimed to evaluate the level of PR inhibition achieved by a 180 mg LD of ticagrelor and the rate of high on-treatment platelet reactivity (HTPR) in ACS patients undergoing PCI.

Methods

We performed a multicentre prospective observational study enrolling ACS patients undergoing PCI. Patients were included if they were admitted for ST-elevation myocardial infarction or non ST-elevation ACS. To assess PR, a VASP index was measured at least 6 and within 24 hours following a 180 mg LD of ticagrelor. HTPR was defined as a VASP index ≥ 50%.

Results

One hundred and fifteen patients were included: 31.3% of STEMI, 49.6% of NSTEMI and 19.1% of unstable angina. Following ticagrelor LD the mean VASP index was 17 ± 14%. However the response to ticagrelor was not uniform with a small inter-individual variability: inter quartile range: 7.6–22.8% and a rate of HTPR of 3.5%. A high number of patients, 65.6%, had a VASP index < 16%. None of the baseline characteristics of the study population was associated with PR. In addition, PR was similar in STEMI, NSTEMI and unstable angina (p = 0.9).

Conclusion

In ACS patients the level of PR inhibition achieved by a 180 mg loading dose of ticagrelor is not uniform and the rate of HTPR is 3.5%. A high proportion of patients exhibited a VASP index < 16%.     

Intraoperative Near-infrared Imaging for Parathyroid Gland Identification by Auto-fluorescence: A Feasibility Study

Background

Parathyroid glands (PGs) can be particularly hard to distinguish from surrounding tissue and thus can be damaged or removed during thyroidectomy. Postoperative hypoparathyroidism is the most common complication after thyroidectomy. Very recently, it has been found that the parathyroid tissue shows near-infrared (NIR) auto-fluorescence which could be used for intraoperative detection, without any use of contrast agents. The work described here presents a histological validation ex vivo of the NIR imaging procedure and evaluates intraoperative PG detection by NIR auto-fluorescence using for the first time to our knowledge a commercially available clinical NIR imaging device.

Methods

Ex vivo study on resected operative specimens combined with a prospective in vivo study of consecutive patients who underwent total or partial thyroid, or parathyroid surgery at a comprehensive cancer center. During surgery, any tissue suspected to be a potential PG by the surgeon was imaged with the Fluobeam 800 ^® system. NIR imaging was compared to conventional histology (ex vivo) and/or visual identification by the surgeon (in vivo).

Results

We have validated NIR auto-fluorescence with an ex vivo study including 28 specimens. Sensitivity and specificity were 94.1 and 80 %, respectively. Intraoperative NIR imaging was performed in 35 patients and 81 parathyroids were identified. In 80/81 cases, the fluorescence signal was subjectively obvious on real-time visualization. We determined that PG fluorescence is 2.93 ± 1.59 times greater than thyroid fluorescence in vivo.

Conclusions

Real-time NIR imaging based on parathyroid auto-fluorescence is fast, safe, and non-invasive and shows very encouraging results, for intraoperative parathyroid identification.

     

Effect of Achilles tendon vibration on postural orientation

Vibration applied to the Achilles tendon is well known to induce in freely standing subjects a backward body displacement and in restrained subjects an illusory forward body tilt. The purpose of the present experiment was to evaluate the effect of Achilles tendon vibration (90Hz) on postural orientation in subjects free of equilibrium constraints. Subjects (n=12) were strapped on a backboard that could be rotated in the antero-posterior direction with the axis of rotation at the level of the ankles. They stood on a rigid horizontal floor with the soles of their feet parallel to the ground. They were initially positioned 7 degrees backward or forward or vertical and were required to adjust their body (the backboard) to the vertical orientation via a joystick. Firstly, results showed that in response to Achilles tendon vibration, subjects adjusted their body backward compared to the condition without vibration. This backward body adjustment likely cancel the appearance of an illusory forward body tilt. It was also observed that the vibratory stimulus applied to the Achilles tendon elicited in restrained standing subjects an increased EMG activity in both the gastrocnemius lateralis and the soleus muscles. Secondly, this vibration effect was more pronounced when passive displacement during the adjustment phase was congruent with the simulated elongation of calf muscles. These results indicated that the perception of body orientation is coherent with the postural response classically observed in freely standing subjects although the relationship between these two responses remains to be elucidated.