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Introduction: Early discharge of patients with acute low-risk pulmonary embolism requires validation by prospective trials with clinical and quality-of-life outcomes., Methods: The multinational Home Treatment of Patients with Low-Risk Pulmonary Embolism with the Oral Factor Xa Inhibitor Rivaroxaban (HoT-PE) single-arm management trial investigated early discharge followed by ambulatory treatment with rivaroxaban. The study was stopped for efficacy after the positive results of the predefined interim analysis at 50% of the planned population. The present analysis includes the entire trial population (576 patients). In addition to 3-month recurrence (primary outcome) and 1-year overall mortality, we analysed self-reported disease-specific (Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire) and generic (five-level five-dimension EuroQoL (EQ-5D-5L) scale) quality of life as well as treatment satisfaction (Anti-Clot Treatment Scale (ACTS)) after pulmonary embolism., Results: The primary efficacy outcome occurred in three (0.5%, one-sided upper 95% CI 1.3%) patients. The 1-year mortality was 2.4%. The mean±sd PEmb-QoL decreased from 28.9±20.6% at 3 weeks to 19.9±15.4% at 3 months, a mean change (improvement) of -9.1% (p<0.0001). Improvement was consistent across all PEmb-QoL dimensions. The EQ-5D-5L was 0.89±0.12 at 3 weeks after enrolment and improved to 0.91±0.12 at 3 months (p<0.0001). Female sex and cardiopulmonary disease were associated with poorer disease-specific and generic quality of life; older age was associated with faster worsening of generic quality of life. The ACTS burden score improved from 40.5±6.6 points at 3 weeks to 42.5±5.9 points at 3 months (p<0.0001)., Conclusions: Our results further support early discharge and ambulatory oral anticoagulation for selected patients with low-risk pulmonary embolism. Targeted strategies may be necessary to further improve quality of life in specific patient subgroups., Competing Interests: Conflict of interest: S. Barco reports personal fees from Biocompatibles Group UK, LEO Pharma, Bayer, nonfinancial support from Bayer HealthCare and Daiichi Sankyo, grants from Sanofi, outside the submitted work. Conflict of interest: I. Schmidtmann reports grants from Merck Serono, outside the submitted work. Conflict of interest: W. Ageno reports grants from Bayer, personal fees from Boehringer Ingelheim, Daiichi Sankyo and Bristol Myers Squibb/Pfizer, outside the submitted work. Conflict of interest: T. Anušić has nothing to disclose. Conflict of interest: R.M. Bauersachs reports personal fees for lectures and advisory board work from Bayer HealthCare, Bristol Myers Squibb/Pfizer and Daiichi Sankyo, during the conduct of the study. Conflict of interest: C. Becattini reports personal fees for consultancy and lectures from Bayer HealthCare, Daiichi Sankyo and Bristol Myers Squibb, outside the submitted work. Conflict of interest: E. Bernardi has nothing to disclose. Conflict of interest: J. Beyer-Westendorf reports patient fees from the Center for Thrombosis and Hemostasis (CTH), University Medical Center Mainz, during the conduct of the study; grants and personal fees for advisory board work, lectures and travel support from Bayer, outside the submitted work. Conflict of interest: L. Bonacchini has nothing to disclose. Conflict of interest: J. Brachmann reports grants and personal fees from Medtronic, during the conduct of the study; grants from Medtronic, St Jude and Biotronik, outside the submitted work. Conflict of interest: M. Christ reports grants from the University of Mainz, during the conduct of the study. Conflict of interest: M. Czihal reports personal fees from Bayer HealthCare, Roche, AstraZeneca, MSD Sharp & Dohme and LEO Pharma, outside the submitted work. Conflict of interest: D. Duerschmied reports personal fees for lectures and nonfinancial support (travel costs) from Bayer, Pfizer, Daiichi Sankyo and CytoSorbents, outside the submitted work. Conflict of interest: K. Empen reports travel costs and personal fees for lectures from Bayer HealthCare, outside the submitted work. Conflict of interest: C. Espinola-Klein reports lecture fees from Bayer HealthCare, outside the submitted work. Conflict of interest: J.H. Ficker reports personal fees for lectures from Daiichi Sankyo, outside the submitted work. Conflict of interest: C. Fonseca reports personal fees for consultancy and lectures from Bayer, outside the submitted work Conflict of interest: S. Genth-Zotz has nothing to disclose. Conflict of interest: D. Jiménez has nothing to disclose. Conflict of interest: V-P. Harjola reports personal fees for lectures from Bayer, personal fees for lectures and advisory board work from Boehringer Ingelheim and Pfizer, personal fees for advisory board work from MSD, outside the submitted work. Conflict of interest: M. Held reports honoraria for advisory board work from Actelion, Bayer, Boehringer, MSD, Daiichi Sankyo and Roche, honoraria for lectures from Actelion, Bayer, Berlin-Chemie, Bristol Myers Squibb, MSD, Daichi Sankyo, Pfizer and OMT, grants from Actelion, outside the submitted work. Conflict of interest: L. Iogna Prat has nothing to disclose. Conflict of interest: T.J. Lange reports nonfinancial support for meeting attendance from the Center for Thrombosis and Hemostasis (CTH), University Medical Center Mainz, during the conduct of the study; personal fees from Bayer and Pfizer, outside the submitted work. Conflict of interest: M. Lankeit reports personal fees for lectures and nonfinancial support (travel costs) from Actelion, Bayer and Daiichi Sankyo, personal fees for lectures from MSD and Bristol Myers Squibb/Pfizer, grants from BRAHMS – Thermo Fisher Scientific, outside the submitted work. Conflict of interest: A. Manolis has nothing to disclose. Conflict of interest: A. Meyer has nothing to disclose. Conflict of interest: T. Münzel has nothing to disclose. Conflict of interest: P. Mustonen reports personal fees for lectures and advisory board work from Boehringer Ingelheim, Bayer, Sanofi-Anetis, LEO Pharma, Bristol Myers Squibb/Pfizer and MSD, outside the submitted work. Conflict of interest: U. Rauch-Kroehnert reports grants from Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Interdisziplinäres Zentrum Klinische Studien (IZKS) during the conduct of the study; personal fees from Bayer Vital, outside the submitted work. Conflict of interest: P. Ruiz-Artacho reports personal fees from Bayer, Daiichi Sankyo, Sanofi, Pfizer, LEO Pharma and Rovi, outside the submitted work. Conflict of interest: S. Schellong reports personal fees for lectures and consultancy from Bayer, Boehringer Ingelheim, Daiichi Sankyo and Aspen, grants and personal fees for lectures and consultancy from Bristol Myers Squibb, outside the submitted work. Conflict of interest: M. Schwaiblmair has nothing to disclose. Conflict of interest: R. Stahrenberg has nothing to disclose. Conflict of interest: L. Valerio has nothing to disclose. Conflict of interest: P.E. Westerweel has nothing to disclose. Conflict of interest: P.S. Wild reports grants and personal fees from Boehringer Ingelheim, Sanofi-Aventis, Bayer Vital and Bayer HealthCare, grants from Philips Medical Systems and Daiichi Sankyo Europe, personal fees from AstraZeneca, personal fees and equipment provision from DiaSorin, equipment provision from IEM, outside the submitted work. Conflict of interest: S.V. Konstantinides reports grants and provision of study drug from Bayer, during the conduct of the study; grants and personal fees for consultancy and lectures from Boehringer Ingelheim, Daiichi Sankyo, Biocompatibles Group UK and MSD, personal fees for consultancy and lectures from Bayer and Bristol Myers Squibb/Pfizer, grants and personal fees for lectures from Actelion, grants from Servier, outside the submitted work., (Copyright ©ERS 2021.)

Objective: The study was established by the International Society for Gynecologic Endoscopy (ISGE) to provide evidence-based recommendations in the steps that should be undertaken in successfully performing a vaginal hysterectomy for a non-prolapsed uterus., Material and Methods: The ISGE Task Force for vaginal hysterectomy for the non-prolapsed uterus defined key clinical questions regarding the surgical technique, which led the Medline/PubMed and the Cochrane Database literature search. Identified pertinent articles, published in English from 1997 to 2019, were analysed. The available information was graded by the level of evidence using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) Working Group approach. The recommendations were developed through multiple cycles of literature analysis and expert discussion., Results: Six recommendations were established: 1. A circular incision at the level of cervico-vaginal junction is recommended (grade IC). 2. The posterior peritoneum should be opened first (grade IC). 3. Clamping and cutting the uterosacral and cardinal ligaments before or after getting access into anterior peritoneum is recommended (grade IC). 4. Routine closure of the peritoneum during vaginal hysterectomy is not recommended (grade IB). 5. Vertical or horizontal closure of the vaginal vault following vaginal hysterectomy is recommended (grade IC). 6. To insert a vaginal plug following vaginal hysterectomy is not recommended (grade IB)., Conclusion: Vaginal hysterectomy for a non-prolapsed uterus should be the preferential route for removing the uterus when hysterectomy is indicated. The ISGE provides evidence-based practical guidelines on how vaginal hysterectomy for non-prolapsed uterus should be undertaken. All efforts should be directed in teaching the surgical technique of vaginal hysterectomy during residency., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Aims: To investigate the efficacy and safety of early transition from hospital to ambulatory treatment in low-risk acute PE, using the oral factor Xa inhibitor rivaroxaban., Methods and Results: We conducted a prospective multicentre single-arm investigator initiated and academically sponsored management trial in patients with acute low-risk PE (EudraCT Identifier 2013-001657-28). Eligibility criteria included absence of (i) haemodynamic instability, (ii) right ventricular dysfunction or intracardiac thrombi, and (iii) serious comorbidities. Up to two nights of hospital stay were permitted. Rivaroxaban was given at the approved dose for PE for ≥3 months. The primary outcome was symptomatic recurrent venous thromboembolism (VTE) or PE-related death within 3 months of enrolment. An interim analysis was planned after the first 525 patients, with prespecified early termination of the study if the null hypothesis could be rejected at the level of α = 0.004 (<6 primary outcome events). From May 2014 through June 2018, consecutive patients were enrolled in seven countries. Of the 525 patients included in the interim analysis, three (0.6%; one-sided upper 99.6% confidence interval 2.1%) suffered symptomatic non-fatal VTE recurrence, a number sufficiently low to fulfil the condition for early termination of the trial. Major bleeding occurred in 6 (1.2%) of the 519 patients comprising the safety population. There were two cancer-related deaths (0.4%)., Conclusion: Early discharge and home treatment with rivaroxaban is effective and safe in carefully selected patients with acute low-risk PE. The results of the present trial support the selection of appropriate patients for ambulatory treatment of PE., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Objective: This project was established by the International Society for Gynecologic Endoscopy (ISGE) to provide evidence-based recommendations on the selection of women in whom vaginal hysterectomy can be safely performed., Study Design: The ISGE Task Force for vaginal hysterectomy for non-prolapsed uterus defined key clinical questions that led the literature search and formulation of recommendations. The search included Medline/PubMed and Cochrane Database. English language articles were reviewed from January 2003 to January 2018, in conjunction with reviews published by the American College of Obstetricians and Gynecologists (ACOG) and the American Association of Gynecologic Laparoscopists (AAGL). The bibliographies of selected works were also checked to acquire additional data where relevant. The available information was graded by the level of evidence using the approach developed by the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) Working Group. For each clinical question, the ISGE recommendations were defined in accordance with the evidence quality., Results: Six recommendations on patient selection for vaginal hysterectomy, including two grade 1B and four grade 2B recommendations were established., Conclusion: Vaginal hysterectomy for non-prolapsed uterus is the treatment of choice for many gynaecological patients in whom hysterectomy is indicated. It may be safely executed, and thus, should be offered to a large group of appropriately selected women, who today are operated in the main by the abdominal or laparoscopic approach. All efforts should be directed towards teaching the technique of vaginal hysterectomy during residency., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Objective: This project of the International Society for Gynecologic Endoscopy (ISGE) had the objective to review the literature and provide recommendations on the occult sarcoma risk assessment in patients who are candidates for minimally invasive gynecological surgery involving intra-abdominal electromechanical tissue morcellation., Study Design: The ISGE Task Force for Estimation of the Risk in Endoscopic Morcellation initially defined key topics and clinical questions which may guide a comprehensive preoperative patient assessment. A literature search within the Medline/PubMed and Cochrane Database was carried out using keywords "morcellation", "uterine fibroids", "uterine sarcoma", "myomectomy" and "hysterectomy". Relevant publications (original studies, meta-analyses and previous reviews), written in English and published until May 30th, 2017, were selected and analyzed. Previously emitted statements of 12 recognized professional societies or government institutions and their supporting literature were also studied. For each topic/clinical question, the available information was graded by the level of evidence. The ISGE recommendations were established in accordance with the evidence quality., Results: In the light of available information, 9 recommendations on preoperative clinical, laboratorial and imaging evaluation of the candidates for intracorporeal uterus/leiomyoma morcellation were formulated, mainly based on consensus and expert opinions. There is a lack of high-quality evidence, which does not allow the establishment of strong recommendations., Conclusion: Electromechanical tissue morcellation may be used in gynecological patients who are considered "low risk" upon appropriate preoperative evaluation; however, further studies and prospective data collection are greatly needed to improve sarcoma risk assessment in women with presumed uterine leiomyomas., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Introduction: Aortic stenosis is the most prevalent type of valvular disease in Europe. Surgical aortic valve replacement (SAVR) is the standard therapy, while transcatheter aortic valve implantation (TAVI) is an alternative in patients at unacceptably high surgical risk. Assessment by a heart team is recommended by the guidelines but there is little published evidence on this subject. The purpose of this paper is to describe the experience of a multidisciplinary TAVI program that began in 2008., Methods: The heart team prospectively assessed 473 patients using a standardized approach. A total of 214 patients were selected for TAVI and 80 for SAVR. Demographic, clinical and procedural characteristics and long-term success rates were compared between the groups., Results: TAVI patients were older than the SAVR group (median 83 vs. 81 years), and had higher surgical risk scores (median EuroSCORE II 5.3 vs. 3.6% and Society of Thoracic Surgeons score 5.1 vs. 3.1%), as did the patients under medical treatment only. These scores were unable to assess multiple comorbidities. Patients' outcomes were different between the three groups (mortality with SAVR 25% vs. TAVI 37.6% vs. conservative therapy 57.6%, p=0.001)., Conclusions: The heart team program was able to select candidates appropriately for TAVI, SAVR and conservative treatment, taking into account the risk of both invasive treatments. The use of a prospective standardized heart team approach is recommended, but requires continuous monitoring to ensure effectiveness in a timely manner., (Copyright © 2017 Sociedade Portuguesa de Cardiologia. Publicado por Elsevier España, S.L.U. All rights reserved.)

Spontaneous delivery through a cervical tear, provoked by prostaglandin-induced uterine contractions, was described in a G2P0 woman with a history of cervical dilatation and uterine curettage. This rare complication with potentially serious maternal-fetal consequences can be predicted by an aberrant cervical response to prostaglandins in parturients with previous cervical interventions.

Background: The intravenous inodilator levosimendan was developed for the treatment of patients with acutely decompensated heart failure. In the last decade scientific and clinical interest has arisen for its repetitive or intermittent use in patients with advanced chronic, but not necessarily acutely decompensated, heart failure. Recent studies have suggested long-lasting favourable effects of levosimendan when administered repetitively, in terms of haemodynamic parameters, neurohormonal and inflammatory markers, and clinical outcomes. The existing data, however, requires further exploration to allow for definitive conclusions on the safety and clinical efficacy of repetitive use of levosimendan., Methods and Results: A panel of 30 experts from 15 countries convened to review and discuss the existing data, and agreed on the patient groups that can be considered to potentially benefit from intermittent treatment with levosimendan. The panel gave recommendations regarding patient dosing and monitoring, derived from the available evidence and from clinical experience., Conclusions: The current data suggest that in selected patients and support out-of-hospital care, intermittent/repetitive levosimendan can be used in advanced heart failure to maintain patient stability. Further studies are needed to focus on morbidity and mortality outcomes, dosing intervals, and patient monitoring. Recommendations for the design of further clinical studies are made., (Copyright © 2014. Published by Elsevier Ireland Ltd.)

Psychotic symptoms in Parkinson's disease (PD) are frequent, disabling, and an important prognostic factor. Thus, screening instruments for detecting psychosis in PD are needed. For this purpose, we applied the Parkinson's Psychosis Questionnaire (PPQ), a short structured questionnaire, which requires no specific training, along with the Brief Psychiatric Rating Scale, expanded version (BPRS-E), for rating general psychopathology, including psychotic symptoms. We evaluated, in a cross-sectional study, a Portuguese sample of 36 early-stage PD patients (mean age of 73 years; mean duration of illness of 3.2 years). The PPQ total score correlated with the BPRS-E total score (0.359; P = 0.032) and with the BPRS-E-positive symptoms score (0.469; P = 0.004). The prevalence of psychosis (41.7%) was higher than expected. Sampling bias and detection of minor psychotic phenomena may have contributed to this result. These findings suggest that the PPQ should be further evaluated as a feasible assessment for psychotic symptoms in PD.