Previously implanted mitral surgical prosthesis in patients undergoing transcatheter aortic valve implantation: Procedural outcome and morphologic assessment using multidetector computed tomography.

Transcatheter aortic valve implantation (TAVI) in the presence of a preexisting mitral prosthesis is challenging and its influence on the morphology of mitral prosthesis and the positioning of transcatheter heart valve (THV) is unknown. We assessed the feasibility of TAVI for patients with preexisting mitral prostheses, its influence on mitral prosthesis morphology, and the positional interaction between a newly implanted THV and mitral prosthesis using serial multidetector computed tomography (MDCT). Thirty-one patients with preexisting mitral prosthesis undergoing TAVI were included. MDCT was performed before and after TAVI. Thirty patients successfully underwent TAVI without interference from preexisting mitral prosthesis. Although opening disturbance of the mechanical mitral prosthesis by the THV edge was observed in 1 patient, the patient was managed conservatively. No THV embolization occurred. THV shift during deployment occurred in 9 patients and was predicted by a larger aortic annulus area (odds ratio: 1.24 per 10 mm2, 1.03-1.49, p = 0.02), possibly because of large THVs. The mitral mean pressure gradient was slightly higher after TAVI (3.7 vs. 4.3 mmHg, p = 0.002), whereas the mitral regurgitation grade was similar. MDCT showed that the size of the mitral prosthesis housing was unchanged after TAVI. The median distance between the mitral prosthesis and THV was 2.6 mm. The postprocedural angle between the mitral prosthesis and THV was larger than the preprocedural angle between the mitral prosthesis and the left ventricular outflow tract (64° vs. 61°, p = 0.03). Thus, TAVI is feasible in the case of preexisting mitral prosthesis. Serial MDCT demonstrated favorable THV positioning and unchanged mitral prosthesis morphology after TAVI.

Assessment of Endoscopic Mucosal Healing of Ulcerative Colitis Using Linked Colour Imaging, a Novel Endoscopic Enhancement System.

BACKGROUND AND AIMS: Mucosal healing and control of intestinal mucosal inflammation are important treatment goals for maintaining clinical remission in ulcerative colitis [UC] patients. Here, we investigated the efficacy of linked colour imaging [LCI], a novel endoscopic enhancement system, for diagnosing mucosal inflammation in UC patients. METHODS: All examinations were carried out with a LASEREO endoscopic system [FUJIFILM Co., Tokyo, Japan]. Fifty-two patients with UC were enrolled, and 193 areas assessed by LCI were examined. LCI patterns were classified as; A, no redness; B, redness with visible vessels; and C, redness without visible vessels. Regions of interest [ROIs] were set at biopsy sites, and the red colour in the ROI was calculated from the Commission internationale de l'éclairage [CIE] color space and digitized [LCI-index]. Biopsy specimens were taken at each ROI and evaluated with Matts histopathological grade. Thirty months was defined as the time interval between endoscopic diagnosis and relapse of UC. RESULTS: Interobserver agreement for LCI classification was excellent between an expert and non-experts. Among areas with a Mayo endoscopic subscore of 0, 41.8% and 4.6% were classified as LCI-B and LCI-C, respectively. Among areas with a Mayo endoscopic subscore of 1, 60.5% and 34.6% were classified as LCI-C and LCI-B, respectively. The LCI index strongly correlated with the histopathological Matts score. Non-relapse rates significantly correlated with LCI classification [p = 0.0055], but not with Mayo endoscopic subscore [p = 0.0632]. CONCLUSION: Endoscopic LCI classification and LCI index can subdivide samples with the same Mayo endoscopic subscore. LCI may be a novel approach for evaluating colonic mucosal inflammation and for predicting outcome in UC patients.

Price offers of pharmaceutical procurement in China: evidence from Guangdong province.

Using a sample from the pharmaceutical procurement in Guangdong, China, over the period from 2007-2009 and a data set of comprehensive potential bidders, this article analyzes the determinants of bidding behaviors in the presence of sample selection. Bidding patterns between highly competitive and less competitive groups are also examined. Price differentials are further decomposed to explain factors that account for the gap. We find that a high level of competitiveness and more winning experiences induce manufacturers to behave aggressively and make lower bids. Moreover, bidders in a less competitive group are less sensitive to the number of potential bidders and the experience of past wins. The decomposition results indicate that the characteristics of bidders are not the main driver for the large price differentials between those groups.

New Approach for Setting a Management Criterion in Microbiological Monitoring Using Rapid Microbiological Methods.

The application of rapid microbiological methods (RMM) to bacterial monitoring in pharmaceutical manufacturing processes is now a key topic, since timely microbiological data are critical for product release, continuous process improvement and quality control. An automated, highly sensitive detection system has been developed which can measure the amount of ATP in a sample in 2 h with one hundredfold more sensitive than the conventional ATP method. One of the major subjects for adoption and implementation of RMM is how to set the criterion value for practical microbial control. This value was conventionally been set by experimental rule and indicated as the number of colonies counted after incubation in a particular medium. We have adopted a new approach to set a criterion value which enables assessment in whether the status of the object is normal or not. By setting this criterion value, it is possible to conduct the microbiological control with the intended probability of false-positive and false-negative. In this approach the probability distribution model of the measurement value of each object in a normal status has been established by performing repetitive measurement of each object. We have suggested and verified the probability distribution form of the ATP measurement value using measurement data of the standard bacterial solution of Staphylococcus aureus. The theoretical value of the model was in good agreement with the actual measured value. The results suggest it is possible to set an applicable management criterion value using this model and to conduct new microbiological monitoring using RMM.

Advantages of diffusion-weighted imaging over positron emission tomography-computed tomography in assessment of hilar and mediastinal lymph node in lung cancer.

BACKGROUND: The significance of diffusion-weighted imaging (DWI) is uncertain for the diagnosis of nodal involvement. The purpose of this study was to examine diagnostic capability of DWI compared with PET-CT for nodal involvement of lung cancer. METHODS: A total of 160 lung cancers (114 adenocarcinomas, 36 squamous cell carcinomas, and 10 other cell types) were analyzed in this study. DWI and PET-CT were performed preoperatively. RESULTS: The optimal cutoff values to diagnose metastatic lymph nodes were 1.70 × 10(-3) mm(2)/s for ADC value and 4.45 for SUVmax. DWI correctly diagnosed N staging in 144 carcinomas (90 %) but incorrectly diagnosed N staging in 16 (10 %) [3 (1.9 %) had overstaging, 13 (8.1 %) had understaging]. PET-CT correctly diagnosed N staging in 133 carcinomas (83.1 %) but incorrectly diagnosed N staging in 27 (16.8 %) [4 (2.5 %) had overstaging, 23 (14.4 %) had understaging]. Sensitivity, accuracy, and negative predictive value for N staging by DWI were significantly higher than those by PET-CT. Of the 705 lymph node stations examined, 61 had metastases, and 644 did not. The maximum diameter of metastatic lesions in lymph nodes were 3.0 ± 0.9 mm in 21 lymph node stations not detected by either DWI or PET-CT: 7.2 ± 4.1 mm in 39 detected by DWI, and 11.9 ± 4.1 mm in 24 detected by PET-CT. There were significant differences among them. The sensitivity (63.9 %) for metastatic lymph node stations by DWI was significantly higher than that (39.3 %) by PET-CT. The accuracy (96.2 %) for all lymph node stations by DWI was significantly higher than that (94.3 %) by PET-CT. CONCLUSIONS: DWI has advantages over PET-CT in diagnosing malignant from benign lymph nodes of lung cancers.

Difficulties in taking aminosalicylates for patients with ulcerative colitis.

Aminosalicylates are effective in inducing remission and are also useful in preventing relapse of ulcerative colitis (UC); however, previous studies have reported a 30%-45% rate of nonadherence to prescribed medication among UC patients. Enumerating and conceptualizing the difficulties in taking aminosalicylates enable us to assess and support patients more effectively. The aim of this study was to investigate the difficulties in taking aminosalicylates among Japanese UC patients and explore factors related to these difficulties. Outpatients with UC (n = 242) completed a questionnaire supported by a semistructured interview on the basis of a literature review. Twelve items about difficulties in taking aminosalicylates were processed by factor analysis and the related factors regarding difficulties were analyzed. The following three independent domains were identified: Domain 1: diminished sense of priority for medication; Domain 2: concern about side effects; and Domain 3: burden of taking the prescribed drug. Factors related to the difficulties in taking aminosalicylates included the disease state, psychosocial factors, and demographic characteristic variables. On the basis of the results, we recommend the creation and validation of a program aimed at decreasing the difficulties in taking aminosalicylates.

Response shift in quality-of-life assessment in patients undergoing curative surgery with permanent colostomy: a preliminary study.

The purpose of this preliminary study (N 13) was to investigate the impact of response shift in quality of life for cancer patients undergoing surgical resection with resultant permanent colostomy. Response shift was measured using a "then-test" approach. Quality of life was measured using the 36-Item Short Form Health Survey version 2 (Japanese version). Baseline data (pretest scores) were collected before surgery when subjects completed the 36-Item Short Form Health Survey. Two months after the surgery, subjects were asked to respond again to the 36-Item Short Form Health Survey to assess their postsurgery quality-of-life (posttest score) level and their presurgery quality-of-life level (then-test score). Norm-based scoring for pretest, posttest, and then-test scores for each of the 36-Item Short Form Health Survey domains was calculated. Response shift was assessed by the difference between pretest and then-test scores and effect size. Findings revealed that a moderate but significant response shift was observed in the bodily pain domain. A small response shift was observed in the role physical and vitality domains. The then-test score was higher than the pretest score. The same trend was observed in all other domains except general health. The results indicate that the unit of comparison in the subjects was changed by surgery. Knowledge of these phenomena would allow a better understanding of quality of life of these subjects.

Health-related quality of life among persons living in Japan with a permanent colostomy.

OBJECTIVE: To compare the health-related quality of life (HRQOL) of persons with a permanent colostomy to that of the general Japanese population and explore the factors influencing HRQOL. DESIGN: A cross-sectional survey. SETTING AND SUBJECTS: A total of 255 persons with an ostomy who attended a meeting of the Japan Ostomy Association in the Kanto region of Japan. INSTRUMENTS: The HRQOL was assessed using Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), Japanese version 1.2. Factors potentially influencing the HRQOL were age, sex, marital status, employment status, number of people in the household, time since colostomy, and diagnosis. METHODS: Questionnaires were distributed to the subjects and SF-36 scores were determined and compared with the corresponding national-norm data by Wilcoxon signed rank sum test. A logistic regression analysis was used to explore the influencing factors. RESULTS: The questionnaire response rate was 66.7%. Subjects with a urostomy or an ileostomy and those with missing data were excluded. Data from 102 subjects with a permanent colostomy were analyzed. The subjects' scores were significantly lower than the national-norm scores in the role-physical and social functioning scales. Being employed was associated with significantly lower scores or associated with a tendency toward lower scores. CONCLUSIONS: Scores in two scales in these subjects were lower than those of national-norm scores. Being employed had a negative impact on the HRQOL of subjects with a permanent colostomy. The results of this study provide reference data for future research and underscore the importance of support for persons with a colostomy.

Ulcerative colitis: factors affecting difficulties of life and psychological well being of patients in remission.

BACKGROUND: Ulcerative colitis is a chronic disease of unknown aetiology characterized by alternating periods of remission and relapses. The difficulties in the patients with ulcerative colitis daily life mostly arise from symptoms associated with bowel inflammation but there are many patients who have difficulties despite being in the remission phase. This study was conducted to elucidate factors that influence perception of difficulties of life and psychological well being of patients with ulcerative colitis in remission. METHODS: A questionnaire survey was carried out in 72 outpatients with ulcerative colitis in remission. The perception of difficulties of life was assessed using the scale developed by Tanaka et al. Psychological well being was assessed using the Japanese version of the 'profile of mood states'. Physical condition, demographic attributes and psychosociological states were also investigated as related factors. RESULTS: There was no outstanding aspect of psychological well being, but a relatively large number of patients perceived a 'decline of vitality or vigour' despite being in the remission phase. In the presence of irritable bowel syndrome-like symptoms, the scores for 'difficulties of life in society' or 'difficulties concerned with bowel movements' were high. Scores for 'decline of vitality or vigour' were high when the emotive coping scores were high, social support was lower, disease durations were short and relapses occurred more than once. When the emotive coping scores were high, psychological well being was not fine. RELEVANCE TO CLINICAL PRACTICE: Strategies need to be developed to allow patients to recover and maintain their strength in the remission phase. Further, the strategies should take the above factors into consideration.

Comparative assessment of ocular tissue distribution of drug-related radioactivity after chronic oral administration of 14C-levofloxacin and 14C-chloroquine in pigmented rats.

Fluoroquinolones have been reported to have a high affinity for melanin. The ocular tissue distribution and accumulation of radioactivity was compared after repeated oral administration of 14C-levofloxacin and 14C-chloroquine at daily doses of 20 mg (0.054 mmol) kg(-1) and 28 mg (0.054 mmol) kg(-1), respectively, in pigmented rats for 84 days. The mean serum level at 24 h following each dose of 14C-levofloxacin was almost constant in the range of 0.33-0.45 nmol equiv mL(-1) after the 14th dose and thereafter. The melanin-containing ocular tissues, such as iris ciliary body and stratum pigment chorioides sclera, showed a much higher concentration of radioactivity than other non-pigmented ocular tissues. The respective concentration in iris ciliary body and stratum pigment chorioides sclera after the 1st dose was 126.47 and 74.91 nmol equiv g(-1), and gradually increased with increasing dose number, reaching 1261.81 and 447.45 nmol equiv g(-1) after the 84th dose, which was ca. 10 and 6 times higher, respectively, than after the 1st dose. The mean serum level following each dose of 14C-chloroquine was almost constant in the range 0.51-0.87 nmol equiv mL(-1) after the 7th dose and thereafter. The respective concentration in iris ciliary body and stratum pigment chorioides sclera after the 1st dose was 572.10 and 709.41 nmol equiv g(-1), and gradually increased with increasing dose number, reaching 33 317.92 and 12 322.90 nmol equiv g(-1) after the 84th dose, which was ca. 58 and 17 times higher, respectively, than after the 1st dose. The concentration in aqueous humour, cornea, lens, vitreous body and retina after the 84th dose was 1.84, 6.33, 0.48, 5.60 and 11.42 nmol equiv g(-1) for 14C-levofloxacin and 18.84, 264.99, 27.26, 158.43 and 1020.89 nmol equiv g(-1) for 14C-chloroquine (ca. 10, 42, 57, 28 and 89 times higher, respectively, than for 14C-levofloxacin). Especially, the concentration in the retina was markedly higher after 14C-chloroquine administration than after 14C-levofloxacin administration. The concentration and the extent of accumulation of radioactivity not only in melanin-containing ocular tissues but also in other non-pigmented ocular tissues, such as retina, after chronic oral administration of 14C-levofloxacin once daily for 84 days were much lower than those after multiple dosing with 14C-chloroquine under the same conditions. These results indicate that levofloxacin would have a much lower risk for ocular toxicity than chloroquine after chronic dosing.

Outcome in patients with lung cancer found on lung cancer mass screening roentgenograms, but who did not subsequently consult a doctor.

GOALS OF THE STUDY: To evaluate the outcome in patients with lung cancer found on lung cancer mass screening roentgenograms, but who did not subsequently consult a doctor. PATIENTS AND METHODS: This study enrolled 198 asymptomatic patients with lung cancer found by lung cancer mass screening during the 9-year period. Five-year survival rates in patients who did not consult a doctor or who stopped consulting a doctor in spite of abnormal shadows detected on last mass screening chest roentgenograms (n=45, delayed consultation group) and in patients who subsequently consulted a doctor when abnormal shadows were detected (n=153, control group) were evaluated by the method of Kaplan and Meier and clinical variables were examined as possible predictors of survival time by the Cox proportional-hazards model. RESULTS: There was a significant difference between the 5-year survival rates in the delayed consultation group and in the control group (21 vs. 51%, log rank: P=0.0003, Wilcoxon: P=0.0009). The risk of death increased 115.0% for the 1-year delay in consultation (hazard ratio: 2.150, 95% CI: 1.203-3.842, P=0.0097). With regard to the reason why they did not consult a doctor, many of them answered that they did not have any respiratory symptoms. CONCLUSION: The 1-year delay in consultation had a great significance in that these patients did not receive any treatment for lung cancer for 1 year, and the 1-year delay in treatment itself affected the outcome.