Patient-reported outcome measures in external and endonasal functional septorhinoplasty - A propensity score matching study.

PURPOSE: Patient satisfaction after functional-aesthetic SRP (faSRP) is highly influenced by the cosmetic result of the surgical procedure. Studies that directly evaluate aesthetic success after external and endonasal faSRP are scarce. The objective of this prospective propensity score matching study was to compare patient-reported satisfaction regarding aesthetic perception following faSRP using the external and endonasal approach in a single-institution single-surgeon survey. MATERIALS AND METHODS: Out of 161 patients operated by the senior author between October 2011 and March 2017, propensity score matching (PSM) computed 54 patients each following external (group 1) or endonasal faSRP (group 2). Patients reported their satisfaction with the aesthetic appearance of the nose on a visual analogue scale (VAS, 0-10) and five Likert scale questions using the Utrecht questionnaire three and twelve months after surgery. RESULTS: The mean preoperative VAS score of 3.46 ± 1.06 improved significantly in all patients after faSRP to 4.54 ± 0.38 (F(1.69;157.04) = 634.01, p < 0.001). The VAS increase did not show any correlation to the surgical approach (F(1;93) = 1.12, p = 0.293). The mean aesthetic sum score (5 = low burden up to 25 = high burden) improved significantly from 13.89 ± 3.78 to 8.46 ± 3.63 after three months (t(95) = 14.021, p < 0.001) and remained almost unchanged after 12 months (8.10 ± 3.76; t(98) = 1.450, p = 0.150) irrespective of the surgical approach (F(1,544;143,587) = 0.126, p = 0.829). CONCLUSIONS: Both the external and endonasal faSRP allowed for significant improvement in patient's aesthetic self-assessment of similar extent.

Outpatient or inpatient treatment for acute pulmonary embolism: a retrospective cohort study of 439 consecutive patients.

Current guidelines consider outpatient treatment as an option for low-risk pulmonary embolism (PE), and risk assessment tools such as the HESTIA criteria can be used to identify PE patients who could feasibly be treated in an outpatient setting. Little is known about what proportion of patients in daily care this would comprise, and, in these patients, outcome data outside of clinical trials are scarce. To assess the proportion of PE patients receiving outpatient early discharge or in-hospital therapy, evaluate differences in patient characteristics between these subgroups and to assess clinical outcomes at 6 months. Monocentric, retrospective cohort study in 439 consecutive patients undergoing outpatient, early-discharge or in-hospital treatment for PE. Outcome data on recurrent VTE, pulmonary hypertension or death were collected from routine follow-up visits 6 months after VTE diagnosis. PE patients were treated as outpatient (OP; n = 49; 11.2 %); early-discharge (ED; n = 62; 14.1 %) or in-hospital (IH; n = 328; 74.7 %). Median duration of hospital stay in the ED and IH groups were 1 (IQR: 1) day and 9 (IQR: 7) days, respectively. Outcome event rates at 6 months were 3.9 % for recurrent VTE (95 % CI 2.3-6.1, similar between groups), 5.2 % for pulmonary hypertension (95 % CI 3.3-7.8, similar between groups) and 10.7 % for mortality (95 % CI 8.0-14.0). Mortality was significantly higher in IH patients (14.0 %; 95 % CI 10.5-18.3) compared to OP (0 %; 95 % CI 0.0-7.3) or ED (1.6 %; 95 % CI 0.0-8.7) patients. Mortality risk factors were high-risk ESC category (OR: 5.7), paraneoplastic VTE (OR: 3.0), need for oxygen supplementation (OR: 5.2), diabetes (OR: 2.5), age (OR per additional year: 1.1) and elevated INR (OR per 0.1 point increase: 1.5). No difference in the treatment groups for pulmonary hypertension during follow-up was found. Independent risk factors were thrombophilia (OR: 8.43), signs of right ventricular strain in baseline ECG (OR: 6.64) or echocardiography (RVESP > 40 mmHg OR: 2.99). 32 % of the OP or ED patients had at least one criterion of the HESTIA score that would have excluded them from outpatient treatment. In daily care, treating PE in an almost exclusively outpatient setting seems feasible and safe for up to 25 % of all PE patients. The HESTIA criteria seem to exclude up to 30 % of patients for whom outpatient or early-discharge treatment seems feasible and safe.

Peri-interventional management of novel oral anticoagulants in daily care: results from the prospective Dresden NOAC registry.

AIMS: Patients receiving novel oral anticoagulants (NOACs) frequently undergo interventional procedures. Short half-lives and rapid onset of action allow for short periods of NOAC interruption without heparin bridging. However, outcome data for this approach are lacking. We evaluated the peri-interventional NOAC management in unselected patients from daily care. METHODS AND RESULTS: Effectiveness and safety data were collected from an ongoing, prospective, non-interventional registry of >2100 NOAC patients. Outcome events were adjudicated using standard event definitions. Of 2179 registered patients, 595 (27.3%) underwent 863 procedures (15.6% minimal, 74.3% minor, and 10.1% major procedures). Until Day 30 ± 5 post-procedure, major cardiovascular events occurred in 1.0% of patients [95% confidence interval (95% CI) 0.5-2.0] and major bleeding complications in 1.2% (95% CI 0.6-2.1). Cardiovascular and major bleeding complications were highest after major procedures (4.6 and 8.0%, respectively). Heparin bridging did not reduce cardiovascular events, but led to significantly higher rates of major bleeding complications (2.7%; 95% CI 1.1-5.5) compared with no bridging (0.5%; 0.1-1.4; P = 0.010). Multivariate analysis demonstrated diabetes [odds ratio (OR) 13.2] and major procedures (OR 7.3) as independent risk factors for cardiovascular events. Major procedures (OR 16.8) were an independent risk factor for major bleeding complications. However, if major and non-major procedures were separately assessed, heparin bridging was not an independent risk factor for major bleeding. CONCLUSION: Continuation or short-term interruption of NOAC is safe strategies for most invasive procedures. Patients at cardiovascular risk undergoing major procedures may benefit from heparin bridging, but bleeding risks need to be considered.

Safety of switching from vitamin K antagonists to dabigatran or rivaroxaban in daily care--results from the Dresden NOAC registry.

AIM: Vitamin-K antagonists (VKA) and non-vitamin-K dependent oral anticoagulants (NOAC) have been approved for anticoagulation in venous thromboembolism (VTE) and atrial fibrillation and patients previously treated with VKA are switched to NOAC therapy. Safety data for this switching are urgently needed. METHODS: Using data from a large regional prospective registry of daily care NOAC patients, we evaluated the safety of switching anticoagulation from VKA to dabigatran or rivaroxaban. Switching procedures and cardiovascular and bleeding events occurring within 30 days after switching were centrally adjudicated. RESULTS: Between 1 October 2011 and 18 June 2013, 2231 patients were enrolled. Of these, 716 patients were switched from VKA to NOAC. Only 410 of the 546 evaluable patients (75.1%) had a recorded INR measurement within the 10 days preceding or following the end of VKA treatment (mean INR 2.4). As of day 30, major bleeding complications were rare (0.3%; 95% CI 0.0, 1.0) with an overall bleeding rate of 12.2% (95% CI 9.8, 14.8). Major cardiovascular events occurred in 0.8% (95% CI 0.3, 1.8). There was no significant difference in outcome event rates between the subgroups of patients with or without INR testing. CONCLUSION: In daily care, only 75% of VKA patients have an INR measurement documented before NOAC are started. On average, NOAC are started within 2 to 5 days after the last intake of VKA. However, at 30 days follow-up cardiovascular events or major bleedings were rare both in patients with and without INR testing. However, switching procedures need to be further evaluated in larger cohorts of patients.

Incidence trends of pediatric onset inflammatory bowel disease in the years 2000-2009 in Saxony, Germany-first results of the Saxon Pediatric IBD Registry.

AIMS: In developed countries, the incidence of inflammatory bowel disease (IBD) such as Crohn's disease (CD) and ulcerative colitis (UC) is increasing. Therefore, we aimed to investigate the incidence rates and trends over time in the population of children and adolescents in one of the federal states of Germany, in Saxony. METHODS: Over the 10-year period 2000-2009 all 31 children's hospitals and pediatric gastroenterologists, respectively in Saxony reported all IBD patients up to 15 years of age to the Saxon Pediatric IBD Registry. The completeness of the registry was estimated as 96.7% by independent surveys in the years 2005-2009. Incidence rates were presented as age-standardized incidence rates (ASR) regarding New European Standard Population 1990 per 100,000 person-years (PY) with 95% confidence intervals [CI]. Joinpoint and linear regression was used for trend analyses. RESULTS: 344 patients with confirmed IBD between 2000-2009 were included in the epidemiological evaluation: 212 (61.6%) patients with CD, 122 (35.6%) with UC and 10 (2.9%) with unclassified IBD (IBD-U). The ASR per 100,000 PY over the whole observation period was 7.2 [6.4-7.9] for IBD, 4.4 [3.8-5.0] for CD, 2.6 [2.1-3.0] for UC and 0.2 [0.1-0.3] for IBD-U. For IBD, the ASR per 100,000 PY increased from 4.6 [2.8-6.3] in 2000 to 10.5 [7.5-13.6] in 2009. The incidence trend analysis of ASRs using the joinpoint regression confirmed a significant increase of IBD as well as UC. The mean age at first diagnosis decreased significantly during the observation period from 11.5 (11.0-13.4) in 2000 to 9.6 (5.1-13.5) years in 2009. The median of the diagnostic latency among IBD patients was 3 months. CONCLUSION: The incidence of IBD in children and adolescents in Saxony was slightly higher than the average of other countries in the same time period and followed the trend towards a general increase of IBD. The age at diagnosis was subject to a very unfavorable downward trend.

Surgical Treatment for Early Stage Glottic Carcinoma with Involvement of the Anterior Commissure.

Objective Assessment of the value of transoral laser microsurgery (TLM) compared with open surgery (OS) for early stage squamous cell carcinoma of the glottic larynx with special regard to involvement of the anterior commissure (AC). Study Design Case series with chart review. Setting Tertiary care otolaryngology clinic. Subjects and Methods Review of clinicopathological data of all patients with previously untreated T1a, T1b, and T2 glottic squamous cell carcinoma of the larynx who were consecutively enrolled over a 10-year period (January 1, 1992, to December 31, 2002). Results Local recurrence rate was 20.4% (10 of 49) for TLM and 10.7% (3 of 28) for OS. Comparison of the TLM and OS groups regarding local recurrence rates revealed a significant difference only for tumors invading the AC ( P = .046). Within the TLM group, tumors with involvement of the AC showed a significantly higher recurrence rate (38.1%; 8 of 21) compared with tumors without involvement of the AC (7.1%; 2 of 28; P = .008). In the OS group, involvement of the AC revealed no significant difference ( P = .45). The overall survival in both groups was comparable in both groups (TLM, 93.9%; OS, 89.3%; P = .47). Conclusion TLM and OS are equally effective surgical treatments for early stage glottic cancer without involvement of the AC, with selection of treatment based on pretreatment endoscopy. However, TLM is associated with less morbidity. In case of invasion of the AC, OS yields lower recurrence rates.

Occupational UV-Exposure is a Major Risk Factor for Basal Cell Carcinoma: Results of the Population-Based Case-Control Study FB-181.

OBJECTIVE: The aim of this study was to investigate the role of occupational and nonoccupational ultraviolet (UV)-exposure concerning the development of basal cell carcinoma (BCC). METHODS: We undertook a population-based multicenter case-control study. Patients with first incident BCC (n = 836) were propensity score matched by age and sex to controls without skin cancer (n = 836). Sociodemographic characteristics, clinical characteristics, and lifetime UV-exposure were assessed by trained investigators. The differential estimation of occupational and nonoccupational UV-exposure dosages was based on validated instruments and established reference values. Associations were assessed using multivariable-adjusted conditional logistic regression models. RESULTS: Individuals with high levels of occupational UV-exposure were at significantly increased BCC-risk compared with individuals with low [odds ratio (OR) 1.84; 95% confidence interval (95% CI) 1.19 to 2.83 and moderate (OR 1.97; 95% CI 1.20 to 3.22) occupational UV-exposure. Nonoccupational UV-exposure was not independently associated with BCC. CONCLUSION: Skin cancer prevention strategies should be expanded to the occupational setting.

Coagulation activation after discontinuation of VTE treatment with different oral anticoagulants and impact on 12-month clinical outcomes.

Increasing D-dimer (DD) levels after discontinuation of vitamin K antagonist (VKA) therapy indicate an increased risk of recurrence of venous thromboembolism (VTE). However, after discontinuation of direct-acting non-VKA oral anticoagulants (DOACs or NOACs) the extent of coagulation activation and its clinical impact is unknown. Blood samples were collected from consenting patients with proximal VTE at the end of anticoagulation treatment with apixaban (n=37), dabigatran (n=17), rivaroxaban (n=9) or VKA (n=184) and 4weeks later. DD, prothrombin fragments F1+2 (F1+2) and thrombin-antithrombin complexes (TAT) were measured. All patients underwent follow-up at 12months to establish recurrent VTE or death from any cause. Irrespective of the treatment, DD and F1+2 but not TAT demonstrated a similar increase between baseline and week 4. At 12months, 18 patients (7.3%) had recurrent VTE and two (0.8%) had died. For all patients and subgroups of VKA and DOAC, positive likelihood ratios were numerically higher for baseline values but only TAT values at 4weeks were found to be related to a small increase of outcome event likelihood (2.6; 95%CI 1.23-5.50), which was driven by VKA patients (3.1; 95%CI 1.32-7.30) and not by DOAC patients (2.27; 95%CI 0.52-9.95). For all parameters, negative likelihood ratios were not predictive. In logistic regression analysis, only ΔTAT (optimal cut-off >178% from baseline demonstrated a significant risk increase for VTE/death (odds ratio 3.76; 95% confidence interval 1.46-9.68; p=0.006). In conclusion, the concept of testing coagulation activation parameters may also be transferred to VTE patients at the end of DOAC therapy. For patients with an increase of TAT levels within 4weeks after treatment discontinuation (>178% from baseline) is associated with an increased risk for VTE recurrence or death at 12months.

Trends in Incidence Rates during 1999-2008 and Prevalence in 2008 of Childhood Type 1 Diabetes Mellitus in Germany--Model-Based National Estimates.

AIMS: To estimate the national incidence rate and trend of type 1 diabetes (T1DM) in Germany from 1999 to 2008 and the national prevalence in 2008 in the age group 0-14 years. METHODS: Data were taken from a nationwide registry for incident cases of T1DM in the ages 0-4 years and 3 regional registries (North-Rhine-Westphalia, Baden-Wuerttemberg and Saxony) for incident cases of T1DM in the ages 0-14 years covering 41% of the child population in Germany. The degree of ascertainment was ≥ 97% in all registries. Incident and prevalent cases were grouped by region, sex, age (0-4, 5-9, 10-14 years), and, for incident data, additionally by two 5-year periods (1999-2003, 2004-2008). Poisson regression models were fitted to the data to derive national estimates of incidence rate trends and prevalence in the age groups 5-9, 10-14 and 0-14 years. We used direct age-standardization. RESULTS: The estimated national incidence rate in 0-14-year-olds increased significantly by 18.1% (95%CI: 11.6-25.0%, p<0.001) from 1999-2003 to 2004-2008, independent of sex, corresponding to an average annual increase of 3.4% (95%-CI: 2.2-4.6%). The overall incidence rate was estimated at 22.9 per 100,000 person-years and we identified a within-country west-east-gradient previously unknown. The national prevalence in the ages 0-14 years on 31/12/2008 was estimated to be 148.1 per 100,000 persons. CONCLUSIONS: The national incidence rate of childhood T1DM in Germany is higher than in many other countries around the world. Importantly, the estimated trend of the incidence rate confirms the international data of a global increase of T1DM incidences.

Efficacy and safety of thromboprophylaxis with low-molecular-weight heparin or rivaroxaban in hip and knee replacement surgery: findings from the ORTHO-TEP registry.

Prospective trials have shown that rivaroxaban thromboprophylaxis is superior over low-molecular-weight heparin (LMWH) in patients undergoing hip and knee replacement surgery. However, patients treated under trial conditions are different from unselected routine patients, which may affect efficacy and safety of thromboprophylaxis. The objective was to evaluate the efficacy and safety of rivaroxaban or LMWH thromboprophylaxis in unselected patients undergoing hip and knee replacement surgery in daily care. In a monocentric, retrospective cohort study in 5,061 consecutive patients undergoing hip and knee replacement surgery a comparison of LMWH (hospital standard in 2006-2007) and rivaroxaban (since 2009) was made with regard to rates of symptomatic VTE, bleeding and surgical complications and length of hospital stay. Rates of symptomatic VTE were 4.1 % (LMWH) and 2.1 % (rivaroxaban; p=0.005) with rates for distal DVT 2.5 vs. 1.1 % (p<0.001). Rates of major VTE were numerically higher with LMWH (1.7 vs. 1.1%, not statistically significant). Rates of major bleeding (overt bleeding leading to surgical revision or death, occurring in a critical site, or transfusion of at least two units of packed red blood cells) were statistically lower with rivaroxaban (2.9 vs. 7.0%; p<0.001). Rivaroxaban patients had fewer surgical complications (1.1 vs. 3.7%; p<0.001) and a shorter length of hospitalisation (8.3 days; 95% CI 8.1- 8.5 vs. 11.1 days; 10.7- 11.5; p< 0.001). We conclude that rivaroxaban thromboprophylaxis is more effective than LMWH in unselected patients undergoing hip and knee replacement surgery in daily care and that switching from LMWH to rivaroxaban could be beneficial. Prospective comparisons are warranted to confirm our findings.

Incidence of childhood diabetes in children aged less than 15 years and its clinical and metabolic characteristics at the time of diagnosis: data from the Childhood Diabetes Registry of Saxony, Germany.

AIMS: The Childhood Diabetes Registry in Saxony, Germany, examined the incidence and metabolic characteristics of childhood diabetes. METHODS: In the federal state of Saxony, newly diagnosed cases of diabetes in children and adolescents aged less than 15 years were registered continuously from 1999 until 2008. Family history, date of diagnosis, clinical and laboratory parameters were obtained. Reported cases were ascertained by public health departments as an independent data source and verified using the capture- recapture method. RESULTS: A total of 865 children and adolescents with newly diagnosed diabetes were registered in Saxony. About 96% of them were classified as having type 1 diabetes, 0.6% had type 2 diabetes, 2.4% had maturity-onset diabetes of the young (MODY), and 1.4% had other types of diabetes. The age-standardized incidence rate of type 1 diabetes was estimated at 17.5 per 100,000 children per year. Completeness of ascertainment as calculated by the capture-recapture method amounted to 93.6%. At the time of diagnosis, 27.1% of children with type 1 diabetes had ketoacidosis, 1.5% had a blood pH <7.0, and 1.1% were unconscious. CONCLUSION: The registry provided data about the incidence rates and clinical presentation of childhood diabetes in a defined German population. We observed higher incidence rates compared to previous surveys.