Flow impairment during protected carotid artery stenting: impact of filter device design

PURPOSE: To investigate the impact of filter design on blood flow impairment in the internal carotid artery (ICA) among patients undergoing carotid artery stenting (CAS) using filter-type emboli protection devices (EPD). METHODS: Between July 2003 and March 2007, 115 filter-protected CAS procedures were performed at an academic institution in 107 consecutive patients (78 men; mean age 68 years, range 38-87). The Angioguard, FilterWire EZ, and Spider filters were used in 68 (59%), 32 (28%), and 15 (13%) of cases, respectively. Patient characteristics, procedural and angiographic data, and outcomes were prospectively entered into an electronic database and reviewed retrospectively along with all angiograms. RESULTS: Flow impairment while the filter was in place was observed in 25 (22%) cases. The presumptive reason of flow impairment was filter obstruction in 21 (18%) instances and flow-limiting spasm at the level of the filter in 4 (4%). In all cases, flow was restored after retrieval of the filter. Flow obstruction in the ICA occurred more frequently with Angioguard (22/68; 32.3%) than with FilterWire EZ (2/32; 6.2%) or Spider (1/15; 6.7%; p = 0.004). No flow occurred in 13 (19%) procedures, all of them protected with Angioguard; no patient treated with other devices experienced this event (p = 0.007). Two (8.0%) strokes occurred in procedures associated with flow impairment, while 1 (1.1%) event was observed in the presence of preserved flow throughout the intervention (p = 0.11). CONCLUSION: Flow impairment in the ICA during filter-based CAS is common and related to the type of filter used.

International Common Otology Database: taste disturbance after stapes surgery

OBJECTIVE: To use a study on dysgeusia to assess the usefulness of an otology database. STUDY DESIGN: Data were extracted from the international Common Otology Database. INTERVENTION: Primary stapes operations. MAIN OUTCOME MEASURE AND RESULTS: From a cohort of 14 otologists, only 8 (57%) were able to satisfy external validation and maintain data input for a period of at least 6 months. The rates of dysgeusia varied from 0 to 39% at 3 months and 0 to 27% at 6 months. The percentages of patients with taste disturbance at 6 months in the "nerve-cut" and "nerve-preserved" groups were 22.7 and 10.9%, respectively, although this was not statistically significant (chi2; p = 0.325). CONCLUSION: Many surgeons found it difficult to maintain a prospective otology database. The rates of certain subjective symptoms such as dysgeusia are influenced by how vigorously the reviewers prompt the response from the patients. Dysgeusia after stapes surgery is common even if the chorda tympani nerve is preserved. Many patients whose chorda tympani nerve is divided may not complain of dysgeusia.

The ARCH Projects: design and rationale (IAASSG 001).

OBJECTIVE A number of factors limit the effectiveness of current aortic arch studies in assessing optimal neuroprotection strategies, including insufficient patient numbers, heterogenous definitions of clinical variables, multiple technical strategies, inadequate reporting of surgical outcomes and a lack of collaborative effort. We have formed an international coalition of centres to provide more robust investigations into this topic. METHODS High-volume aortic arch centres were identified from the literature and contacted for recruitment. A Research Steering Committee of expert arch surgeons was convened to oversee the direction of the research. RESULTS The International Aortic Arch Surgery Study Group has been formed by 41 arch surgeons from 10 countries to better evaluate patient outcomes after aortic arch surgery. Several projects, including the establishment of a multi-institutional retrospective database, randomized controlled trials and a prospectively collected database, are currently underway. CONCLUSIONS Such a collaborative effort will herald a turning point in the surgical management of aortic arch pathologies and will provide better powered analyses to assess the impact of varying surgical techniques on mortality and morbidity, identify predictors for neurological and operative risk, formulate and validate risk predictor models and review long-term survival outcomes and quality-of-life after arch surgery.

German Total Ankle Replacement Register of the German Foot and Ankle Society (D. A. F.) - presentation of design and reliability of the data as well as first results

INTRODUCTION Even though arthroplasty of the ankle joint is considered to be an established procedure, only about 1,300 endoprostheses are implanted in Germany annually. Arthrodeses of the ankle joint are performed almost three times more often. This may be due to the availability of the procedure - more than twice as many providers perform arthrodesis - as well as the postulated high frequency of revision procedures of arthroplasties in the literature. In those publications, however, there is often no clear differentiation between revision surgery with exchange of components, subsequent interventions due to complications and subsequent surgery not associated with complications. The German Orthopaedic Foot and Ankle Association's (D. A. F.) registry for total ankle replacement collects data pertaining to perioperative complications as well as cause, nature and extent of the subsequent interventions, and postoperative patient satisfaction. MATERIAL AND METHODS The D. A. F.'s total ankle replacement register is a nation-wide, voluntary registry. After giving written informed consent, the patients can be added to the database by participating providers. Data are collected during hospital stay for surgical treatment, during routine follow-up inspections and in the context of revision surgery. The information can be submitted in paper-based or online formats. The survey instruments are available as minimum data sets or scientific questionnaires which include patient-reported outcome measures (PROMs). The pseudonymous clinical data are collected and evaluated at the Institute for Evaluative Research in Medicine, University of Bern/Switzerland (IEFM). The patient-related data remain on the register's module server in North Rhine-Westphalia, Germany. The registry's methodology as well as the results of the revisions and patient satisfaction for 115 patients with a two year follow-up period are presented. Statistical analyses are performed with SAS™ (Version 9.4, SAS Institute, Inc., Cary, NC, USA). RESULTS About 2½ years after the register was launched there are 621 datasets on primary implantations, 1,427 on follow-ups and 121 records on re-operation available. 49 % of the patients received their implants due to post-traumatic osteoarthritis, 27 % because of a primary osteoarthritis and 15 % of patients suffered from a rheumatic disease. More than 90 % of the primary interventions proceeded without complications. Subsequent interventions were recorded for 84 patients, which corresponds to a rate of 13.5 % with respect to the primary implantations. It should be noted that these secondary procedures also include two-stage procedures not due to a complication. "True revisions" are interventions with exchange of components due to mechanical complications and/or infection and were present in 7.6 % of patients. 415 of the patients commented on their satisfaction with the operative result during the last follow-up: 89.9 % of patients evaluate their outcome as excellent or good, 9.4 % as moderate and only 0.7 % (3 patients) as poor. In these three cases a component loosening or symptomatic USG osteoarthritis was present. Two-year follow-up data using the American Orthopedic Foot and Ankle Society Ankle and Hindfoot Scale (AOFAS-AHS) are already available for 115 patients. The median AOFAS-AHS score increased from 33 points preoperatively to more than 80 points three to six months postoperatively. This increase remained nearly constant over the entire two-year follow-up period. CONCLUSION Covering less than 10 % of the approximately 240 providers in Germany and approximately 12 % of the annually implanted total ankle-replacements, the D. A. F.-register is still far from being seen as a national registry. Nevertheless, geographical coverage and inclusion of "high-" (more than 100 total ankle replacements a year) and "low-volume surgeons" (less than 5 total ankle replacements a year) make the register representative for Germany. The registry data show that the number of subsequent interventions and in particular the "true revision" procedures are markedly lower than the 20 % often postulated in the literature. In addition, a high level of patient satisfaction over the short and medium term is recorded. From the perspective of the authors, these results indicate that total ankle arthroplasty - given a correct indication and appropriate selection of patients - is not inferior to an ankle arthrodesis concerning patients' satisfaction and function. First valid survival rates can be expected about 10 years after the register's start.

A new universal, standardized implant database for product identification: a unique tool for arthroplasty registries.

INTRODUCTION Every joint registry aims to improve patient care by identifying implants that have an inferior performance. For this reason, each registry records the implant name that has been used in the individual patient. In most registries, a paper-based approach has been utilized for this purpose. However, in addition to being time-consuming, this approach does not account for the fact that failure patterns are not necessarily implant specific but can be associated with design features that are used in a number of implants. Therefore, we aimed to develop and evaluate an implant product library that allows both time saving barcode scanning on site in the hospital for the registration of the implant components and a detailed description of implant specifications. MATERIALS AND METHODS A task force consisting of representatives of the German Arthroplasty Registry, industry, and computer specialists agreed on a solution that allows barcode scanning of implant components and that also uses a detailed standardized classification describing arthroplasty components. The manufacturers classified all their components that are sold in Germany according to this classification. The implant database was analyzed regarding the completeness of components by algorithms and real-time data. RESULTS The implant library could be set up successfully. At this point, the implant database includes more than 38,000 items, of which all were classified by the manufacturers according to the predefined scheme. Using patient data from the German Arthroplasty Registry, several errors in the database were detected, all of which were corrected by the respective implant manufacturers. CONCLUSIONS The implant library that was developed for the German Arthroplasty Registry allows not only on-site barcode scanning for the registration of the implant components but also its classification tree allows a sophisticated analysis regarding implant characteristics, regardless of brand or manufacturer. The database is maintained by the implant manufacturers, thereby allowing registries to focus their resources on other areas of research. The database might represent a possible global model, which might encourage harmonization between joint replacement registries enabling comparisons between joint replacement registries.

Clinical Perspectives from Randomized Phase 3 Trials on Prostate Cancer: An Analysis of the ClinicalTrials.gov Database

AbstractBackground It is not easy to overview pending phase 3 trials on prostate cancer (PCa), and awareness of these trials would benefit clinicians. Objective To identify all phase 3 trials on {PCa} registered in the ClinicalTrials.gov database with pending results. Design and setting On September 29, 2014, a database was established from the records for 175 538 clinical trials registered on ClinicalTrials.gov. A search of this database for the substring “prostat” identified 2951 prostate trials. Phase 3 trials accounted for 441 studies, of which 333 concerned only PCa. We selected only ongoing or completed trials with pending results, that is, for which the primary endpoint had not been published in a peer-reviewed medical journal. Results and limitations We identified 123 phase 3 trials with pending results. Trials were conducted predominantly in North America (n = 63; 51) and Europe (n = 47; 38). The majority were on nonmetastatic disease (n = 82; 67), with 37 (30) on metastatic disease and four trials (3) including both. In terms of intervention, systemic treatment was most commonly tested (n = 71; 58), followed by local treatment 34 (28), and both systemic and local treatment (n = 11; 9), with seven (6) trials not classifiable. The 71 trials on systemic treatment included androgen deprivation therapy (n = 34; 48), chemotherapy (n = 15; 21), immunotherapy (n = 9; 13), other systemic drugs (n = 9; 13), radiopharmaceuticals (n = 2; 3), and combinations (n = 2; 3). Local treatments tested included radiation therapy (n = 27; 79), surgery (n = 5; 15), and both (n = 2; 2). A limitation is that not every clinical trial is registered on ClinicalTrials.gov. Conclusion There are many {PCa} phase 3 trials with pending results, most of which address questions regarding systemic treatments for both nonmetastatic and metastatic disease. Radiation therapy and androgen deprivation therapy are the interventions most commonly tested for local and systemic treatment, respectively. Patient summary This report describes all phase 3 trials on prostate cancer registered in the ClinicalTrials.gov database with pending results. Most of these trials address questions regarding systemic treatments for both nonmetastatic and metastatic disease. Radiation therapy and androgen deprivation therapy are the interventions most commonly tested for local and systemic treatment, respectively.

Ceramic formulation and processing design for plutonium disposition

The focus of this research programme is to develop a single phase ceramic wasteform for waste PuO2 that is unsuitable for fuel manufacture. A suite of synthetic mineral systems have been considered including titanate, zirconate, phosphate and silicate based matrices. Although a wealth of information on plutonium disposition in some of the systems exists in the literature, the data is not always directly comparable which hinders comparison between different ceramic hosts. The crux of this research has been to compile a database of information on the proposed hosts to allow impartial comparison of the relative merits of each system. © 2009 Materials Research Society.