Influence of wound closure on volume stability with the application of different GBR materials: an in vitro cone-beam computed tomographic study.

PURPOSE: To assess the influence of using different combinations of guided bone regeneration (GBR) materials on volume changes after wound closure at peri-implant dehiscence defects. METHODS: In 5 pig mandibles, standardized bone defects were created and implants were centrally placed. The defects were augmented using different combinations of GBR materials: xenogeneic granulate and collagen membrane (group 1, n=10), xenogeneic granulate and alloplastic membrane (group 2, n=10), alloplastic granulates and alloplastic membrane (group 3, n=10). The horizontal thickness was assessed using cone-beam computed tomography before and after suturing. Measurements were performed at the implant shoulder (HT0) and at 1 mm (HT1) and 2 mm (HT2) below. The data were statistically analysed using the Wilcoxon signed-rank test to evaluate within-group differences. Bonferroni correction was applied when calculating statistical significance between the groups. RESULTS: The mean horizontal thickness before suturing was 2.55±0.53 mm (group 1), 1.94±0.56 mm (group 2), and 2.49±0.73 mm (group 3). Post-suturing, the values were 1.47±0.31 mm (group 1), 1.77±0.27 mm (group 2), and 2.00±0.48 mm (group 3). All groups demonstrated a loss of horizontal dimension. Intragroup changes exhibited significant differences in group 1 (P<0.001) and group 3 (P<0.01). Intergroup comparisons revealed statistically significant differences of the relative changes between groups 1 and 2 (P=0.033) and groups 1 and 3 (P=0.015). CONCLUSIONS: Volume change after wound closure was minimized by using an alloplastic membrane. The stability of the augmented horizontal thickness was most ensured by using this type of membrane irrespective of the bone substitute material used for membrane support.

The Comprehensive Complication Index CCI: A proposed modification to optimize short-term complication reporting after cystectomy and urinary diversion.

OBJECTIVE: To optimize complication reporting in patients undergoing cystectomy and urinary diversion (UD) using the Comprehensive Complication Index (CCI). The original CCI ranging from 0 (no complications) to 100 (death) integrates all complications weighted by severity over time in a single formula. However, due to the large number of complications after cystectomy and UD, the CCI may exceed the upper limit. METHODS: In an observational single-center cohort, 90-day postoperative complications in 1,313 consecutive patients undergoing cystectomy and UD from 2000 to 2017 were evaluated. Prospectively collected complications were graded according to the Clavien-Dindo classification (CDC). A modified Berne CCI was developed using an exponential function, which transforms the sum of the weights into a value between 0 and 100. The correlation between the Berne and original CCI values was depicted graphically. Finally, original CCI and Berne CCI values for each patient were extracted and compared. Predictive values of CCI scores for mortality or severe complications (CDC ≥IV) within 1 year postoperatively were investigated by use of multiple logistic regression analyses. RESULTS: Overall complication rate was 82%, with CDC grade I to II in 56% and CDC grade IIIa to V in 27% respectively. Applying the original CCI, the upper limit was exceeded in 8 patients, with a maximal value of 119.1 (median 25.7 [interquartile range: 20.9-37.2]). The maximal value of the Berne CCI was 99.4 (21.2 [14.6-39.3]) for nondeath cases. The Berne CCI predicted the onset of death and severe complications between postoperative day 91 and 365 (both P <0.0001), whereas the original CCI was only predictive in interaction with other variables but not alone (P = 0.2772 and P = 0.0862, respectively). CONCLUSION: The optimized Berne CCI depicts postoperative morbidity and burden within 90 days after cystectomy and UD without exceeding the upper index limit. It is specifically suited for longitudinal assessment of complications after cystectomy and UD taking into consideration every single complication and corresponding treatment. As the Berne CCI well predicted the onset of mortality and severe complications within 1 year postoperatively, this may allow a better preoperative patient counselling. It therefore warrants consideration for standardized reporting of complications after cystectomy and UD.

Metastases in normal-sized pelvic lymph nodes: detection with diffusion-weighted MR imaging.

PURPOSE: To prospectively assess the diagnostic performance of diffusion-weighted (DW) magnetic resonance (MR) imaging in the detection of pelvic lymph node metastases in patients with prostate and/or bladder cancer staged as N0 with preoperative cross-sectional imaging. MATERIALS AND METHODS: This study was approved by an independent ethics committee. Written informed consent was obtained from all patients. Patients with no enlarged lymph nodes on preoperative cross-sectional images who were scheduled for radical resection of the primary tumor and extended pelvic lymph node dissection were enrolled. All patients were examined with a 3-T MR unit, and examinations included conventional and DW MR imaging of the entire pelvis. Image analysis was performed by three independent readers blinded to any clinical information. Metastases were diagnosed on the basis of high signal intensity on high b value DW MR images and morphologic features (shape, border). Histopathologic examination served as the standard of reference. Sensitivity and specificity were calculated, and bias-corrected 95% confidence intervals (CIs) were obtained with the bootstrap method. The Fleiss and Cohen κ and median test were applied for statistical analyses. RESULTS: A total of 4846 lymph nodes were resected in 120 patients. Eighty-eight lymph node metastases were found in 33 of 120 patients (27.5%). Short-axis diameter of these metastases was less than or equal to 3 mm in 68, more than 3 mm to 5 mm in 13, more than 5 mm to 8 mm in five; and more than 8 mm in two. On a per-patient level, the three readers correctly detected metastases in 26 (79%; 95% CI: 64%, 91%), 21 (64%; 95% CI: 45%, 79%), and 25 (76%; 95% CI: 60%, 90%) of the 33 patients with metastases, with respective specificities of 85% (95% CI: 78%, 92%), 79% (95% CI: 70%, 88%), and 84% (95% CI: 76%, 92%). Analyzed according to hemipelvis, lymph node metastases were detected with histopathologic examination in 44 of 240 pelvic sides (18%); the three readers correctly detected these on DW MR images in 26 (59%; 95% CI: 45%, 73%), 19 (43%; 95% CI: 27%, 57%), and 28 (64%; 95% CI: 47%, 78%) of the 44 cases. CONCLUSION: DW MR imaging enables noninvasive detection of small lymph node metastases in normal-sized nodes in a substantial percentage of patients with prostate and bladder cancer diagnosed as N0 with conventional cross-sectional imaging techniques.

Protective effect of A/H1N1 vaccination in immune-mediated disease--a prospectively controlled vaccination study.

OBJECTIVES: To assess the 2009 influenza vaccine A/H1N1 on antibody response, side effects and disease activity in patients with immune-mediated diseases. METHODS: Patients with RA, SpA, vasculitis (VAS) or CTD (n = 149) and healthy individuals (n = 40) received a single dose of adjuvanted A/H1N1 influenza vaccine. Sera were obtained before vaccination, and 3 weeks, 6 weeks and 6 months thereafter. A/H1N1 antibody titres were measured by haemagglutination inhibition (HAI) assay. Seroprotection was defined as specific antibody titre ≥ 1 : 40, seroconversion as 4-fold increase in antibody titre. RESULTS: Titres increased significantly in patients and controls with a maximum at Week 3, declining to levels below protection at Month 6 (P < 0.001). Seroprotection was more frequently reached in SpA and CTD than in RA and VAS (80 and 82% and 57 and 47%, respectively). There was a significantly negative impact by MTX (P < 0.001), rituximab (P = 0.0031) and abatacept (P = 0.045). Other DMARDs, glucocorticoids and TNF blockers did not significantly suppress response (P = 0.06, 0.11 and 0.81, respectively). A linear decline in response was noted in patients with increasing age (P < 0.001). Disease reactivation possibly related to vaccination was suspected in 8/149 patients. No prolonged side effects or A/H1N1 infections were noted. CONCLUSIONS: The results show that vaccination response is a function of disease type, intensity and character of medication and age. A single injection of adjuvanted influenza vaccine is sufficient to protect a high percentage of patients. Therefore, differential vaccination recommendations might in the future reduce costs and increase vaccination acceptance.

Symptom assessment in lumbar stenosis/spondylolysis - patient questionnaire versus physician chart.

BACKGROUND: The precision of symptom assessment and documentation in daily routine is unknown. Differences in hip studies have been observed between the charts and the patient questionnaires. This was the reason to perform this study and to compare the charts and the patient questionnaires. METHODS: This was a retrospective study of physician versus patient symptom ratings in spondylolysis/spinal stenosis patients before and after lumbar spinal surgery. Symptoms were assessed just prior to surgery and 3 and 12 months after surgery, by patients using self-administered validated questionnaire (NASS lumbar element) and by physicians recording notes in patient charts. Presence or absence of symptoms was analysed for back/buttock pain, leg pain, and neurological signs. Agreement between patient and physician rating was scored as total (agreement in all 3 categories), partial (agreement in 1 or 2 categories) or none, at each time point. RESULTS: A total of 44 patients completed the study; average age was 63 years; 68% were women. Symptoms in all 3 symptom categories were reduced significantly 3 and 12 months after surgery, especially leg pain and neurological symptoms. Total agreement between patient and physician ratings of symptoms was substantially lower after surgery (22-28%) than before (50%). This was mainly attributable to physicians reporting less leg pain and neurological signs after surgery than patients. Total agreement was lower for older patients. CONCLUSIONS: The agreement of main symptoms between the charts and the patient questionnaires seems to be low and may be ameliorated with more time and more structured interviews to ensure that the physician's patient chart more closely reflects the patient's self-rating, than was the case in this study.

Pilot study on the comprehensive economic costs of major trauma: Consequential costs are well in excess of medical costs.

BACKGROUND: Trauma care is expensive. However, reliable data on the exact lifelong costs incurred by a major trauma patient are lacking. Discussion usually focuses on direct medical costs--underestimating consequential costs resulting from absence from work and permanent disability. METHODS: Direct medical costs and consequential costs of 63 major trauma survivors (ISS >13) at a Swiss trauma center from 1995 to 1996 were assessed 5 years posttrauma. The following cost evaluation methods were used: correction cost method (direct cost of restoring an original state), human capital method (indirect cost of lost productivity), contingent valuation method (human cost as the lost quality of life), and macroeconomic estimates. RESULTS: Mean ISS (Injury Severity Score) was 26.8 +/- 9.5 (mean +/- SD). In all, 22 patients (35%) were disabled, causing discounted average lifelong total costs of USD 1,293,800, compared with 41 patients (65%) who recovered without any disabilities with incurred costs of USD 147,200 (average of both groups USD 547,800). Two thirds of these costs were attributable to a loss of production whereas only one third was a result of the cost of correction. Primary hospital treatment (USD 27,800 +/- 37,800) was only a minor fraction of the total cost--less than the estimated cost of police and the judiciary. Loss of quality of life led to considerable intangible human costs similar to real costs. CONCLUSIONS: Trauma costs are commonly underestimated. Direct medical costs make up only a small part of the total costs. Consequential costs, such as lost productivity, are well in excess of the usual medical costs. Mere cost averages give a false estimate of the costs incurred by patients with/without disabilities.