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This review on magnetic resonance elastography (MRE) of the breast provides an overview of available literature and describes current developments in the field of breast MRE, including new transducer technology for data acquisition and multi‐frequency‐derived power‐law behaviour of tissue. Moreover, we discuss the future potential of breast MRE, which goes beyond its original application as an additional tool in differentiating benign from malignant breast lesions. These areas of ongoing and future research include MRE for pre‐operative tumour delineation, staging, monitoring and predicting response to treatment, as well as prediction of the metastatic potential of primary tumours. [ABSTRACT FROM AUTHOR]

Aims Recurrent ischaemia, detected by continuous ECG monitoring, in patients with unstable angina increases the risk of unfavourable outcome. Studies that evaluated this relationship have been limited by the small series of patients. By combining data from three studies, the present analysis aims to provide an accurate assessment of the impact of recurrent ischaemia detected by multilead ECG-ischaemia monitoring on the occurrence of death and myocardial infarction in patients with acute coronary syndromes.Methods and Results Data were obtained from CAPTURE, PURSUIT and FROST, three trials evaluating glycoprotein IIb/IIIa blockers in patients with non-ST-elevation acute coronary syndromes. Patients were monitored for 24h after enrolment with a computer-assisted 12-lead or a vectorcardiographic ECG–ischaemia monitoring device. In a retrospective blinded analysis, recurrent ischaemic episodes were identified by a computer algorithm. The number of ischaemic episodes was normalized to 24h. Ischaemic episodes were detected in 271 (27%) of 995 patients. There was a direct proportional relationship between the number of ischaemic episodes per 24h and the probability of cardiac events at 5 and 30 days. The 30-day composite of death and myocardial infarction occurred in 5·7% of patients without episodes and increased to 19·7% in patients with ≥5 episodes. After adjustment for baseline predictors of adverse outcome, the relative risk of death or myocardial infarction at 5 and 30 days increased by 25% for each additional ischaemic episode per 24h.Conclusions This analysis emphasizes the need for integration of multilead ECG–ischaemia monitoring systems in coronary care units and emergency wards to improve early risk stratification in patients with acute coronary syndromes. [ABSTRACT FROM PUBLISHER]

In 10 patients undergoing diagnostic cardiac catheterisation a bolus of 15 mg ST 567 was administered intravenously in 1.5 min followed by a 30 min infusion of 7.5 mg. The maximal plasma level was 343 ± 131 ng ml-1 (mean ± s.d.) 1 min after bolus injection and stabilised around 179 ng ml-1 thereafter. Heart rate decreased from 71 ± 10 beats min-1 at baseline to 66 ± 10 beats min-1 at the end of the bolus injection (–7%). This decrease in heart rate persisted during the whole observation period. Also there was an 8% reduction in peak positive first derivative of LV pressure. Cardiac output measured by thermodilution during atrial pacing decreased from 5.9 ± 1.1 1 min-1 to 5.3 ± 0.71 min-1 (P < 0.02). In 3 patients with the largest decrease in cardiac output, the end diastolic LV pressure at the end of the observation period decreased, which may reflect a decrease in pre-load. Only in 1 patient the decrease in end diastolic LV pressure exceeded twice the standard deviation of the random error component of duplicate measurements. Thus, although normal therapeutic plasma levels were achieved, ST 567 demonstrated negative inotropic properties independent of changes in heart rate with this scheme of administration. [ABSTRACT FROM PUBLISHER]

Aims Thrombin plays a key role in the clinical syndrome of unstable angina. We investigated the safety and efficacy of five dose levels of efegatran sulphate, a direct thrombin inhibitor, compared to heparin in patients with unstable angina.Methods Four hundred and thirty-two patients with unstable angina were enrolled. Five dose levels of efegatran were studied sequentially, ranging from 0·105mg.kg−1.h−1to 1·2mg.kg−1.h−1over 48h. Safety was assessed clinically, with reference to bleeding and by measuring clinical laboratory parameters. Efficacy was assessed by the number of patients experiencing any episode of recurrent ischaemia as measured by computer-assisted continuous ECG ischaemia monitoring. Clinical end-points were: episodes of recurrent angina, myocardial infarction, coronary intervention (PTCA or CABG), and death.Results Efegatran demonstrated dose dependent ex-vivo anticoagulant activity with the highest dose level of 1·2mg.kg−1.h−1resulting in steady state mean activated partial thromboplastin time values of approximately three times baseline. Thrombin time was also increased. Neither of the efegatran doses studied were able to suppress myocardial ischaemia during continuous ECG ischaemia monitoring to a greater extent than that seen with heparin. There were no statistically significant differences in clinical outcome or major bleeding between the efegatran and heparin groups. Minor bleeding and thrombophlebitis occurred more frequently in the efegatran treated patients.Conclusion Administration of efegatran sulphate at levels of at least 0·63mg.kg−1.h−1provided an anti-thrombotic effect which is at least comparable to an activated partial thromboplastin time adjusted heparin infusion. There was no excess of major bleeding. The level of thrombin inhibition by efegatran, as measured by activated partial thromboplastin time, appeared to be more stable than with heparin. Thus, like other thrombin inhibitors, efegatran sulphate is easier to administer than heparin. However, no clinical benefits of efegatran over heparin were apparent. [ABSTRACT FROM PUBLISHER]

Aims The selection of ECG leads used for ST monitoring may influence detection and quantitation of ischaemia. Methods We compared on-line continuous 48-h 12-lead against 3-lead ST monitoring in 130 unstable angina patients (Mortara, ELI-100). Onset and offset of ST episodes were defined by the lead with the first ≥100 μV ST change relative to baseline and the lead with the latest return to baseline ST level, respectively. ST episodes were calculated for 12 leads and 3 leads (V2, V5, III) separately. Results ST episodes were detected in 88 patients (77%) by 12-lead and in 71 patients (62%) by 3-lead ST monitoring (P<0·02). The median number (25, 75%) of episodes/patient was 1 (0, 3) for 3-lead and 2 (1, 6) for 12-lead (p<0·0001). The total duration of ischaemia detected during 12-lead far exceeded 3-lead monitoring: 12·3 (1, 58·2) and 1·7 (0, 23·3) min respectively (p<0·0001). The probability of recurrent ischaemia declined most during the first 24 h of monitoring. After a period without ST changes of 1, 12, 24 and 36 h, the probabilities of recurrent ischaemia were 63, 31, 14 and 9%, respectively. Conclusions Continuous 12-lead ST monitoring increases detection rate and duration of ST episodes compared to 3-lead ST monitoring. The use of continuous 12-lead ECG monitoring devices on emergency wards and coronary care units is recommended. [ABSTRACT FROM PUBLISHER]

In the GUSTO-I ECG ischaemia monitoring substudy, 1067 patients underwent continuous ST segment monitoring, using vector-derived 12-lead (406 patients), 12-lead (373 patients) and 3-lead Holter (288 patients) ECG recording systems. Simultaneous angiograms at 90 or 180 min following thrombolytic therapy were performed as a part of the prospective study in 302 patients.Infarct vessel patency was established as TIMI perfusion grades 2 or 3 and occlusion as TIMI perfusion grades 0 or 1. Coronary artery patency was predicted from ST trends up to the time of angiography. Predictive values at 90 and 180 min after the start of thrombolysis were 70% and 82% for patency and 58% and 64% for occlusion, respectively. In retrospect, accuracy appeared greatest (79–100%) in patients with extensive ST segment elevation (≥400 μV), if both speed of ST recovery and extent of ST segment: elevation were taken into account. Although the three recording systems differed considerably in signal processing, no significant difference in accuracy was demonstrated among these systems.We conclude that continuous ECG monitoring may help select high risk patients without apparent reperfusion who may benefit from additional reperfusion therapy. As ST recovery may occur early after the start of thrombolytics and accuracy of the test is related to peak ST levels, the use of on-line ECG monitoring devices on emergency wards and cardiac care units is recommended. (Eur Heart J 1996; 17: 689–698) [ABSTRACT FROM PUBLISHER]

Existing challenges in surgical education (See one, do one, teach one) as well as the COVID-19 pandemic make it necessary to develop new ways for surgical training. Therefore, this work describes the implementation of a scalable remote solution called "TeleSTAR" using immersive, interactive and augmented reality elements which enhances surgical training in the operating room. The system uses a full digital surgical microscope in the context of Ear-Nose-Throat surgery. The microscope is equipped with a modular software augmented reality interface consisting an interactive annotation mode to mark anatomical landmarks using a touch device, an experimental intraoperative image-based stereo-spectral algorithm unit to measure anatomical details and highlight tissue characteristics. The new educational tool was evaluated and tested during the broadcast of three live XR-based three-dimensional cochlear implant surgeries. The system was able to scale to five different remote locations in parallel with low latency and offering a separate two-dimensional YouTube stream with a higher latency. In total more than 150 persons were trained including healthcare professionals, biomedical engineers and medical students., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Purpose: We evaluated the effect of Internet-based cognitive behavioral therapy (iCBT), with or without therapist support, on the perceived impact of hot flushes and night sweats (HF/NS) and overall levels of menopausal symptoms (primary outcomes), sleep quality, HF/NS frequency, sexual functioning, psychological distress, and health-related quality of life in breast cancer survivors with treatment-induced menopausal symptoms., Patients and Methods: We randomly assigned 254 breast cancer survivors to a therapist-guided or a self-managed iCBT group or to a waiting list control group. The 6-week iCBT program included psycho-education, behavior monitoring, and cognitive restructuring. Questionnaires were administered at baseline and at 10 weeks and 24 weeks postrandomization. We used mixed-effects models to compare the intervention groups with the control group over time. Significance was set at P < .01. An effect size (ES) of .20 was considered small, .50 moderate and clinically significant, and .80 large., Results: Compared with the control group, the guided and self-managed iCBT groups reported a significant decrease in the perceived impact of HF/NS (ES, .63 and .56, respectively; both P < .001) and improvement in sleep quality (ES, .57 and .41; both P < .001). The guided group also reported significant improvement in overall levels of menopausal symptoms (ES, .33; P = .003), and NS frequency (ES, .64; P < .001). At longer-term follow-up (24 weeks), the effects remained significant, with a smaller ES for the guided group on perceived impact of HF/NS and sleep quality and for the self-managed group on overall levels of menopausal symptoms. Additional longer-term effects for both intervention groups were found for hot flush frequency., Conclusion: iCBT, with or without therapist support, has clinically significant, salutary effects on the perceived impact and frequency of HF/NS, overall levels of menopausal symptoms, and sleep quality.

Background: Support for guiding and monitoring postoperative recovery and resumption of activities is usually not provided to patients after discharge from the hospital. Therefore, a perioperative electronic health (eHealth) intervention ("ikherstel" intervention or "I recover" intervention) was developed to empower gynecological patients during the perioperative period. This eHealth intervention requires a need for further development for patients who will undergo various types of general surgical and gynecological procedures., Objective: This study aimed to further develop the "ikherstel" eHealth intervention using Intervention Mapping (IM) to fit a broader patient population., Methods: The IM protocol was used to guide further development of the "ikherstel" intervention. First, patients' needs were identified using (1) the information of a process evaluation of the earlier performed "ikherstel" study, (2) a review of the literature, (3) a survey study, and (4) focus group discussions (FGDs) among stakeholders. Next, program outcomes and change objectives were defined. Third, behavior change theories and practical tools were selected for the intervention program. Finally, an implementation and evaluation plan was developed., Results: The outcome for an eHealth intervention tool for patients recovering from abdominal general surgical and gynecological procedures was redefined as "achieving earlier recovery including return to normal activities and work." The Attitude-Social Influence-Self-Efficacy model was used as a theoretical framework to transform personal and external determinants into change objectives of personal behavior. The knowledge gathered by needs assessment and using the theoretical framework in the preparatory steps of the IM protocol resulted in additional tools. A mobile app, an activity tracker, and an electronic consultation (eConsult) will be incorporated in the further developed eHealth intervention. This intervention will be evaluated in a multicenter, single-blinded randomized controlled trial with 18 departments in 11 participating hospitals in the Netherlands., Conclusions: The intervention is extended to patients undergoing general surgical procedures and for malignant indications. New intervention tools such as a mobile app, an activity tracker, and an eConsult were developed., Trial Registration: Netherlands Trial Registry NTR5686; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5686., (©Chantal M den Bakker, Frederieke G Schaafsma, Eva van der Meij, Wilhelmus JHJ Meijerink, Baukje van den Heuvel, Astrid H Baan, Paul HP Davids, Petrus C Scholten, Suzan van der Meij, W Marchien van Baal, Annette D van Dalsen, Daniel J Lips, Jan Willem van der Steeg, Wouter KG Leclercq, Peggy MAJ Geomini, Esther CJ Consten, Steven E Schraffordt Koops, Steve MM de Castro, Paul JM van Kesteren, Huib A Cense, Hein BAC Stockmann, A Dorien ten Cate, Hendrik J Bonjer, Judith AF Huirne, Johannes R Anema. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 06.02.2019.)

As part of a larger, randomized controlled trial, we evaluated longitudinally the sexual functioning and relationship satisfaction of 69 partners of breast cancer (BC) survivors who received Internet-based cognitive behavioral therapy (CBT) for sexual dysfunction. The findings suggest that Internet-based CBT positively affects the partners' immediate post-CBT and longer-term overall sexual satisfaction, sexual intimacy, and sexual relationship satisfaction. No sustained changes in other areas of sexual functioning were observed. Our CBT program was focused primarily on the sexual health of the BC survivors. We recommend that future programs include more psychoeducational and behavioral elements targeted at the partners.

The study aim was to evaluate the long-term efficacy of Internet-based cognitive behavioral therapy (CBT) for sexual dysfunctions in 84 breast cancer survivors. The positive effects of the intervention on overall sexual functioning, sexual desire, sexual arousal, vaginal lubrication, discomfort during sex, sexual distress, and body image observed immediately posttreatment were maintained at three- and nine-month follow-ups. Although sexual pleasure decreased during follow-up, it did not return to baseline levels. Our findings provide evidence that Internet-based CBT has a sustained, positive effect on sexual functioning and body image of breast cancer survivors with a sexual dysfunction.

An altered intestinal microbiota composition has been implicated in the pathogenesis of metabolic disease including obesity and type 2 diabetes mellitus (T2DM). Low grade inflammation, potentially initiated by the intestinal microbiota, has been suggested to be a driving force in the development of insulin resistance in obesity. Here, we report that bacterial DNA is present in mesenteric adipose tissue of obese but otherwise healthy human subjects. Pyrosequencing of bacterial 16S rRNA genes revealed that DNA from the Gram-negative species Ralstonia was most prevalent. Interestingly, fecal abundance of Ralstonia pickettii was increased in obese subjects with pre-diabetes and T2DM. To assess if R. pickettii was causally involved in development of obesity and T2DM, we performed a proof-of-concept study in diet-induced obese (DIO) mice. Compared to vehicle-treated control mice, R. pickettii-treated DIO mice had reduced glucose tolerance. In addition, circulating levels of endotoxin were increased in R. pickettii-treated mice. In conclusion, this study suggests that intestinal Ralstonia is increased in obese human subjects with T2DM and reciprocally worsens glucose tolerance in DIO mice.

Purpose We evaluated the effect of Internet-based cognitive behavioral therapy (CBT) on sexual functioning and relationship intimacy (primary outcomes) and body image, menopausal symptoms, marital functioning, psychological distress, and health-related quality of life (secondary outcomes) in breast cancer survivors (BCSs) with a DSM-IV diagnosis of a sexual dysfunction. Patients and Methods We randomly assigned 169 BCSs to either Internet-based CBT or a waiting-list control group. The CBT consisted of weekly therapist-guided sessions, with a maximum duration of 24 weeks. Self-report questionnaires were completed by the intervention group at baseline (T0), midtherapy (T1), and post-therapy (T2) and at equivalent times by the control group. We used a mixed-effect modeling approach to compare the groups over time. Results Compared with the control group, the intervention group showed a significant improvement over time in overall sexual functioning (effect size for T2 [ES T2 ] = .43; P = .031), which was reflected in an increase in sexual desire (ES T1 = .48 and ES T2 = .72; P < .001), sexual arousal (ES T2 = .50; P = .008), and vaginal lubrication (ES T2 = .46; P = .013). The intervention group reported more improvement over time in sexual pleasure (ES T1 = .32 and ES T2 = .62; P = .001), less discomfort during sex (ES T1 = .49 and ES T2 = .66; P = .001), and less sexual distress (ES T2 = .59; P = .002) compared with the control group. The intervention group reported greater improvement in body image (ES T2 = .45; P = .009) and fewer menopausal symptoms (ES T1 = .39; P = .007) than the control group. No significant effects were observed for orgasmic function, sexual satisfaction, intercourse frequency, relationship intimacy, marital functioning, psychological distress, or health-related quality of life. Conclusion Internet-based CBT has salutary effects on sexual functioning, body image, and menopausal symptoms in BCSs with a sexual dysfunction.

Background: Due to the strong reduction in the length of hospital stays in the last decade, the period of in-hospital postoperative care is limited. After discharge from the hospital, guidance and monitoring on recovery and resumption of (work) activities are usually not provided. As a consequence, return to normal activities and work after surgery is hampered, leading to a lower quality of life and higher costs due to productivity loss and increased health care consumption., Objective: With this study we aim to evaluate whether an eHealth care program can improve perioperative health care in patients undergoing commonly applied abdominal surgical procedures, leading to accelerated recovery and to a reduction in costs in comparison to usual care., Methods: This is a multicenter randomized, single-blinded, controlled trial. At least 308 patients between 18 and 75 years old who are on the waiting list for a laparoscopic cholecystectomy, inguinal hernia surgery, or laparoscopic adnexal surgery for a benign indication will be included. Patients will be randomized to an intervention or control group. The intervention group will have access to an innovative, perioperative eHealth care program. This intervention program consists of a website, mobile phone app, and activity tracker. It aims to improve patient self-management and empowerment by providing guidance to patients in the weeks before and after surgery. The control group will receive usual care and will have access to a nonintervention (standard) website consisting of the digital information brochure about the surgical procedure being performed. Patients are asked to complete questionnaires at 5 moments during the first 6 months after surgery. The primary outcome measure is time to return to normal activities based on a patient-specific set of 8 activities selected from the Patient-Reported Outcomes Measurement Information System (PROMIS) physical functioning item bank version 1.2. Secondary outcomes include social participation, self-rated health, duration of return to work, physical activity, length of recovery, pain intensity, and patient satisfaction. In addition, an economic evaluation alongside this randomized controlled trial will be performed from the societal and health care perspective. All statistical analyses will be conducted according to the intention-to-treat principle., Results: The enrollment of patients started in September 2015. The follow-up period will be completed in February 2017. Data cleaning and analyses have not begun as of the time this article was submitted., Conclusions: We hypothesize that patients receiving the intervention program will resume their normal activities sooner than patients in the control group and costs will be lower., Clinicaltrial: Netherlands Trial Registry NTC4699; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4699 (Archived by WebCite at http://www.webcitation.org/6mcCBZmwy)., Competing Interests: EM, JH, EB, CB, and JA are the developers of the care program under study. JA and JH are setting up a spin-off company concerning the implementation of a mobile application concerning the IKHERSTEL intervention in the Netherlands., (©Eva van der Meij, Judith AF Huirne, Esther VA Bouwsma, Johanna M van Dongen, Caroline B Terwee, Peter M van de Ven, Chantal M den Bakker, Suzan van der Meij, W Marchien van Baal, Wouter KG Leclercq, Peggy MAJ Geomini, Esther CJ Consten, Steven E Schraffordt Koops, Paul JM van Kesteren, Hein BAC Stockmann, A Dorien ten Cate, Paul HP Davids, Petrus C Scholten, Baukje van den Heuvel, Frederieke G Schaafsma, Wilhelmus JHJ Meijerink, H Jaap Bonjer, Johannes R Anema. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 21.12.2016.)

Context: Studies indicate adverse effects of breast cancer (BC) and cancer treatment on cognitive function., Objectives: To investigate the effects of systemic treatment on cognitive performance in BC patients., Methods: Participants were BC patients scheduled to receive systemic treatment (BC + SYST; n = 31), or no systemic treatment (BC; n = 24) and no-cancer (NC) controls (n = 33). Neuropsychological examinations were used to study cognitive performance on 18 tests grouped into eight cognitive domains, before adjuvant treatment (T1) and six months after chemotherapy (T2), or at similar intervals. We also assessed health-related quality of life, anxiety and depression, mood, stress, and cognitive problems. Analysis of variance was used to assess group differences of cognitive performance and multivariate normative comparison to classify impairment, comparing scores of each participant against the distribution of the scores of NC controls., Results: Of BC + SYST, 16% were cognitively impaired at T2, compared to 4% in BC and 6% in NC. Although not significant, we observed moderate effect sizes for worse performance in the BC + SYST group compared to NC (Flanker congruent [effect size {ES} = 0.44] and stimulus incongruent [ES = 0.44]) and compared to BC (Controlled Oral Word Association Test [ES = 0.47], digit span [ES = 0.41], and Hopkins Verbal Learning Test immediate [ES = 0.71] and delayed recall [ES = 0.65]). Cognitively impaired patients had a significantly lower estimated premorbid intelligence, worse physical and social functioning, and more distress at T2 compared to unimpaired patients., Conclusion: Our findings indicate that cognitive impairment after systemic treatment occurs in a subset of BC patients. The predictive value of demographic and psychosocial factors in cognitive impairment should be further investigated in a larger sample of impaired patients., (Copyright © 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Purpose: The purpose of our study was to evaluate the effect of cognitive behavioral therapy (CBT), physical exercise (PE), and of these two interventions combined (CBT/PE) on menopausal symptoms (primary outcome), body image, sexual functioning, psychological well-being, and health-related quality of life (secondary outcomes) in patients with breast cancer experiencing treatment-induced menopause., Patients and Methods: Patients with breast cancer reporting treatment-induced menopausal symptoms (N=422) were randomly assigned to CBT (n=109), PE (n=104), CBT/PE (n=106), or to a waiting list control group (n=103). Self-report questionnaires were completed at baseline, 12 weeks, and 6 months. Multilevel procedures were used to compare the intervention groups with the control group over time., Results: Compared with the control group, the intervention groups had a significant decrease in levels of endocrine symptoms (Functional Assessment of Cancer Therapy-Endocrine Symptoms; P<.001; effect size, 0.31-0.52) and urinary symptoms (Bristol Female Lower Urinary Tract Symptoms Questionnaire; P=.002; effect size, 0.29-0.33), and they showed an improvement in physical functioning (36-Item Short Form Health Survey physical functioning subscale; P=.002; effect size, 0.37-0.46). The groups that included CBT also showed a significant decrease in the perceived burden of hot flashes and night sweats (problem rating scale of the Hot Flush Rating Scale; P<.001; effect size, 0.39-0.56) and an increase in sexual activity (Sexual Activity Questionnaire habit subscale; P=.027; effect size, 0.65). Most of these effects were observed at both the 12-week and 6-month follow-ups., Conclusion: CBT and PE can have salutary effects on endocrine symptoms and, to a lesser degree, on sexuality and physical functioning of patients with breast cancer experiencing treatment-induced menopause. Future work is needed to improve the design and the planning of these interventions to improve program adherence.

Background: Improvements in quality of life (QOL) obtained by weight loss have mainly been reported after bariatric surgery. QOL has not been investigated in surgical patients first losing weight by nonsurgical means followed by a surgical intervention and never simultaneously by two QOL-a generic and a disease-specific-questionnaires., Methods: Prospective data were obtained from 40 consecutive patients (mean age 36.6 years, body weight 142.4 kg, body mass index (BMI) 46.5 kg/m2). Two different QOL questionnaires, the generic Medical Outcomes Study Short Form-36 (SF-36) and the disease-specific Health-Related Quality of Life (HRQL) questionnaire, were evaluated at three points in time: at the start, 3 months after the placement of an intragastric balloon that remained in situ for 6 months, and 3 months after subsequent gastric banding., Results: QOL scores revealed a significant improvement in many health domains, with an earlier improvement with the disease-specific HRQL, whereas the generic QOL questionnaire lagged behind. However, in the end, the SF-36 caught up completely to normal-weight levels, whereas some scales of the HRQL remained below these levels. Work productivity and involvement in sports improved significantly. BMI declined significantly over time, but no correlation with SF-36 and HRQL score changes was found., Conclusion: The QOL improved substantially independent of changes in BMI. Because of the divergent outcomes of generic and disease-specific QOL questionnaires, prospective studies should examine the sensitivity to changes of both kinds of QOL questionnaires.

Background: We studied whether weight loss by intragastric balloon would predict the outcome of subsequent gastric banding with regard to weight loss and BMI reduction., Methods: A prospective cohort of patients with a body mass index (BMI)>40 kg/m(2) received an intragastric balloon for 6 months followed by laparoscopic adjustable gastric banding (LAGB). Successful balloon-induced weight loss was defined as > or =10% weight loss after 6 months. Successful surgical weight loss was defined as an additional 15% weight loss in the following 12 months. Patients were divided in group A, losing > or =10% of their initial weight with 6 months' balloon treatment, and group B, losing <10% of their initial weight., Results: In 40 patients (32 female, 8 male; age 36.6 yr, range 26-54), the mean BMI decreased from 46.5 to 40.5 kg/m(2) (P<0.001) after 6 months of balloon treatment and to 35.2 kg/m(2) (P<0.001) 12 months after LAGB. Group A (25 patients) and group B (15 patients) had a significant difference in BMI decrease, 12.4 vs 9.0 kg/m(2) (P<0.05), after the total study duration of 18 months. However, there was no difference in BMI reduction (4.7 kg/m(2) vs 5.8 kg/m(2)) in the 12 months after LAGB. 6 patients in group A lost > or =10% of their starting weight during 6 months balloon treatment as well as > or =15% 12 months following LAGB. 6 patients in group B lost <10% of their starting weight after 6 months of BIB, but also lost > or =15% 12 months following LAGB., Conclusion: Intragastric balloon did not predict the success of subsequent LAGB.

In this report, we describe a patient with adventitial cystic disease of the popliteal artery, in which direct communication via a duct-like structure between the cystic lesion and the knee-joint synovium resulted in recurrent episodes of intermittent claudication and complete symptom-free intervals (intermittent claudication intermittence). This unusual observation could shed more light on the debated etiology of the disease. Moreover, it emphasizes the importance of complete excision of the cyst along with the presenting anatomic connection with the knee joint.

In many health conditions, people are severely affected by health-related stigma and discrimination. A literature review was conducted to identify stigma-reduction strategies and interventions in the field of HIV/AIDS, mental illness, leprosy, TB and epilepsy. The review identified several levels at which interventions and strategies are being implemented. These are the intrapersonal, interpersonal, organizational/institutional, community and governmental/structural level. Although a lot of work has been carried out on stigma and stigma reduction, far less work has been done on assessing the effectiveness of stigma-reduction strategies. The effective strategies identified mainly concentrated on the individual and the community level. In order to reduce health-related stigma and discrimination significantly, single-level and single-target group approaches are not enough. What is required is a patient-centred approach, which starts with interventions targeting the intrapersonal level, to empower affected persons to assist in the development and implementation of stigma-reduction programmes at other levels.

Objective: To investigate whether the orientation of the electrical T-axis and the spatial QRS-T angle provide independent diagnostic and prognostic information in patients presenting with acute chest pain., Methods: Patients with symptoms suggestive of acute cardiac pathology, who were seen by a general practitioner and for whom a prehospital electrocardiogram (ECG) was recorded by the ambulance service between 1992 and 1994 were investigated. The ECGs (n = 2,261) for our study population were stored for off-line analysis by the Modular ECG Analysis System. QRS- and T-axes were computed from the reconstructed vectorcardiographic X, Y and Z leads. During the year 2000, a follow-up of the entire cohort was performed, and the vital status of the patients was determined via the civil registrar's office. Cox multivariable regression analyses were performed to evaluate the relation between the orientation of the T-axis, the spatial QRS-T angle and long-term mortality., Results: An abnormal orientation of the T-axis and the spatial QRS-T angle were associated with an increased likelihood of cardiac diseases and an increased risk of all-cause mortality during short- and long-term follow-up., Conclusions: We conclude that the frontal T-axis and the spatial QRS-T angle are important determinants of diagnosis and prognosis in patients presenting with acute chest pain. The reintroduction of vectorcardiography in routine clinical practice might therefore be reconsidered., (Copyright 2004 S. Karger AG, Basel)

Aims: Presence of axillary lymph node metastases is considered the most important prognostic factor for breast cancer survival. In a period of increasing popularity for the sentinel node procedure, clarity about the possible relation between axillary dissection and survival is essential. This study investigated whether the total number of removed lymph nodes and the ratio of invaded/removed lymph nodes (lymph node ratio (LNR) would prove to be independent prognostic factors for survival., Methods: Data from 453 consecutive patients with stage I or II breast cancer were studied retrospectively. The total number of removed lymph nodes and the LNR were analysed for their prognostic value in comparison with known prognostic factors., Results: Node-negative patients with < 14 lymph nodes removed had a 10 year survival of 79% compared with 89% in patients with > or = 14 lymph nodes removed (P=0.005). The 10 year survival for patients with an LNR > or = 0.2 was 52%, compared with 73% for patients with an LNR < 0.2 (P<0.0001). A Cox proportional hazards model showed that, for node-negative patients, only age and total number of removed lymph nodes were significant prognostic factors. For node-positive patients, age, total number of removed lymph nodes and the LNR were significant risk factors for survival outcome. The LNR was also significantly associated with the presence of distant metastases during follow-up (hazard ratio 3.56, range 1.63-7.77)., Conclusions: In stage I and II breast cancer, a favourable prognosis was found for node-negative patients with > or = 14 removed lymph nodes. Before axillary lymph node dissection with its well-defined survival prognosis is replaced by less invasive staging methods, long-term survival using new staging techniques needs to be defined. For node-positive patients, the LNR proved to be an excellent predictor for survival outcome or development of metastatic disease. Selection of lymph node-positive patients based on the LNR may guide specific adjuvant treatment choices.

Background: Electrocardiogram variations (ECG) due to body position changes and electrode placements are common problems of continuous ST-T monitoring. Body position changes may cause QRS and ST-T changes and trigger false alarms. Placement of arm and leg electrodes in a coronary care unit environment is usually near the thorax instead of standard position at the wrists and ankles. This may affect the limb leads and complicate diagnostic interpretation. The purpose of this study was to assess the effects of these sources of ECG variation and to correct for them. Continuous 12-lead ECG recordings were obtained from 160 patients admitted to the coronary care unit. Each patient underwent a body position test (supine, left-lateral, and upright position). Scalar and spatial approaches were investigated for reconstruction of the ECG in supine position. The scalar approach uses linear regression. The spatial approach transforms the ECG into a derived vestorcardiogram. The spatial QRS-loop is then rotated and scaled to match the vector loop in supine position and transformed back to a 12-lead ECG., Materials and Methods: To assess the effect of electrode placement, monitoring and standard limb leads were simultaneously recorded in a group of 80 patients. To map the monitoring leads to standard leads, general and patient-specific reconstruction coefficients were derived by linear regression from half of the patients and tested on the other half. Similarity between the reference and reconstructed ECGs was measured by correlation, similarity coefficient [(SC=1-RMS(residual error)/RMS(signal)], and difference in frontal QRS-Axis., Results and Conclusion: Only 14% (23 of 160) of the patients showed marked ECG changes (ST elevations, QRS-axis shifts, T-wave inversions). The scalar method (median correlation > 0.994, SC > 0.902, QRS axis difference 0 degrees) performed better than spatial (median correlation 0.946, SC > 0.792, QRS axis difference 0 degrees). Monitoring leads can be mapped to standard limb leads in good to excellent approximaiton. General reconstruction (median correlation 0.993 and SC 0.764) performed slightly worse than patient-specific reconstruction (median correlation 0.997 and SC 0.908).

Computer-assisted continuous monitoring of the ST-segment allows detection and quantification of recurrent ischemia in patients with acute coronary syndromes. In a substudy of the PURSUIT (Platelet glycoprotein IIb/IIIa in Unstable angina: Receptor Suppression Using Integrilin Therapy) trial, this technique was used to evaluate the effects of the glycoprotein IIb/IIIa inhibitor eptifibatide on the incidence and severity of recurrent ischemia, and to investigate the relationship between recurrent ischemia and the occurrence of subsequent death or myocardial (re)infarction. A total of 258 patients with unstable angina or evolving myocardial infarction without ST elevation were monitored for 24 hours during infusion with either eptifibatide or placebo with a computer-assisted 12-lead ECG-ischemia monitoring device. Recurrent ischemic episodes were identified by an automated computer algorithm. Two hundred and sixteen patients (84%) had ECG recordings suitable for analysis. Ischemic episodes were detected in 35 (33%) of the 105 eptifibatide patients and in 32 (29%) of the 111 placebo patients (not significant). No difference in ischemic burden was apparent between both treatment groups. Patients who exhibited 2 or more episodes of recurrent ischemia more frequently died or suffered a myocardial infarction, both at 7 and 30 days, as well as through the 6-month follow-up. A greater ischemic burden was significantly related to adverse outcome during the 6-month follow-up period. Real-time computer-assisted continuous multilead ECG-ischemia monitoring may help to identify patients with unstable coronary syndromes at increased risk of adverse outcome and, thus, allow for better prognostic triage and more appropriate selection of therapeutic strategies. Integration of these systems in coronary care units and emergency wards should, therefore, be recommended.

It may not always be possible to record all precordial leads of the standard 12-lead electrocardiogram (ECG). Especially in monitoring situations, a minimal lead set from which the 12-lead ECG can be reconstructed, would be valuable. This article assesses how well missing precordial leads could be synthesized from the remaining leads of the 12-lead ECG. A total of 2,372 diagnostic 12-lead ECG recordings were obtained from subjects with chest pain suggestive for acute myocardial infarction. Representative average beats were computed from the digital 12-lead ECG recordings with our Modular ECG Analysis System. The recordings were divided into a learning set and a test set. We considered all lead sets with one or more precordial leads removed, but always including limb leads I and II. By using the learning set, general reconstruction coefficients were computed to synthesize the missing precordial leads to each lead set. Performance of the synthesis was assessed by cross correlation between the original and the reconstructed leads. Also, patient-specific reconstruction coefficients were derived for each ECG in the test set and correlations were determined. High correlation coefficients were found with both reconstruction techniques. For different sizes of lead sets, the best patient-specific reconstructions had higher correlation values than the general reconstructions. For example, when 2 precordial leads were excluded, the best patient-specific median correlation was 0.994 compared to 0.963 for the best general reconstruction correlation. General reconstruction allows synthesis of 2 or 3 excluded precordial leads in good approximation. When patient-specific reconstruction can be applied, a minimal lead set including the limb leads and only 2 precordial leads suffices.

Background: The aim of this study was to evaluate whether in patients with myocardial infarction, the intensity and duration of myocardial ischemia as measured by continuous ST monitoring are associated with infarct size and residual left ventricular function., Methods and Results: The analyses included patients with myocardial infarction, receiving thrombolytic therapy, who were enrolled in the electrocardiographic substudy of GUSTO-I, monitored by a vector-derived 12-lead electrocardiographic recording system, and in whom either infarct size (defined as cumulative release of alpha-hydroxybutyrate dehydrogenase activity per liter of plasma over a 72-hour period [Q(72)]) or left ventricular ejection fraction (LVEF) was determined. With the use of linear regression analysis, we investigated the association of various ST-trend characteristics with Q(72) (206 patients) and with LVEF (180 patients). A higher area under the ST trend since thrombolysis until 50% ST recovery and a higher area under recurrent ischemic episodes (ST reelevations) were significantly associated with a higher Q(72), whereas only a higher area under recurrent ischemic episodes was significantly associated with a lower LVEF. These associations remained after adjusting for other patient characteristics such as age, sex, infarct location, and time to treatment., Conclusions: These findings support the physiologic hypothesis that both the intensity and duration of myocardial ischemia (both reflected by the estimated areas under the ST-trend curve) determine myocardial damage and thus are associated with infarct size and ejection fraction in patients with acute myocardial infarction who receive thrombolytic therapy.

Aim: To evaluate the clinical and prognostic value of the heart rate variability index in patients with congestive heart failure., Methods: Sixty-four patients with chronic congestive heart failure and sinus rhythm underwent clinical assessment, 24-h ambulatory electrocardiography and echocardiography. Patients were followed for 6 to 30 months. Cardiac death or heart transplantation constituted the primary end-point of the study., Results: The heart rate variability index was related to left ventricular ejection fraction (r=0.29, P=0.02) and New York Heart Association class (P=0.01). Patients with a restrictive left ventricular filling pattern had a lower heart rate variability index compared to patients with a non-restrictive pattern (26+/-11 vs 33+/-9 units, P=0.01). Patients who died (n=11) or underwent heart transplantation (n=4) had a lower heart rate variability index compared to survivors (21+/-10 vs 33+/-9 units, P<0.0001). In multivariate survival analysis, a reduced heart rate variability index was related to survival independent of parameters of left ventricular function., Conclusion: The heart rate variability index provides independent information on clinical status and prognosis in patients with chronic congestive heart failure.

Background: In the CAPTURE (c7E3 Fab Anti Platelet Therapy in Unstable REfractory angina) trial, 1265 patients with refractory unstable angina were treated with abciximab or placebo, in addition to standard treatment from 16 to 24 hours preceding coronary intervention through 1 hour after intervention. To investigate the incidence of recurrent ischemia and the ischemic burden, a subset of 332 patients (26%) underwent continuous vector-derived 12-lead ECG-ischemia monitoring., Methods and Results: Patients were monitored from start of treatment through 6 hours after coronary intervention. Ischemic episodes were detected in 31 (18%) of the 169 abciximab and in 37 (23%) of the 163 placebo patients (NS). Only 9 (5%) of abciximab versus 22 (14%) of placebo patients had >/=2 ST episodes (P<0.01). In patients with ischemia, abciximab significantly reduced total ischemic burden (P<0.02), which was calculated alternatively as the total duration of ST episodes per patient, the area under the curve of the ST vector magnitude during episodes, or the sum of the areas under the curves of 12 leads during episodes. Twenty-one patients (6%) suffered a myocardial infarction (MI) (18) or died (3) within 5 days of treatment. The presence of asymptomatic and symptomatic ST episodes during the monitoring period preceding coronary intervention was associated with an increased relative risk of these events of 3.2 (95% CI 1.4, 7.4) and 4.1 (95% CI 1.4, 12.2), respectively., Conclusions: Recurrent ischemia predicts MI or death within 5 days of follow-up. Treatment with abciximab is associated with a reduction of frequent ischemia and a reduction of total ischemic burden in patients with refractory unstable angina. As such, patients with ischemia derive particularly high benefit from abciximab.

In the GUSTO-I ECG ischaemia monitoring substudy, 1067 patients underwent continuous ST segment monitoring, using vector-derived 12-lead (406 patients), 12-lead (373 patients) and 3-lead Holter (288 patients) ECG recording systems. Simultaneous angiograms at 90 or 180 min following thrombolytic therapy were performed as a part of the prospective study in 302 patients. Infarct vessel patency was established as TIMI perfusion grades 2 or 3 and occlusion as TIMI perfusion grades 0 or 1. Coronary artery patency was predicted from ST trends up to the time of angiography. Predictive values at 90 and 180 min after the start of thrombolysis were 70% and 82% for patency and 58% and 64% for occlusion, respectively. In retrospect, accuracy appeared greatest (79-100%) in patients with extensive ST segment elevation (> or = 400 microV), if both speed of ST recovery and extent of ST segment elevation were taken into account. Although the three recording systems differed considerably in signal processing, no significant difference in accuracy was demonstrated among these systems. We conclude that continuous ECG monitoring may help select high risk patients without apparent reperfusion who may benefit from additional reperfusion therapy. As ST recovery may occur early after the start of thrombolytics and accuracy of the test is related to peak ST levels, the use of on-line ECG monitoring devices on emergency wards and cardiac care units is recommended.