Darolutamide in Combination With Androgen-Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer From the Phase III ARANOTE Trial.

Purpose: For patients with metastatic hormone-sensitive prostate cancer (mHSPC), delaying progression to castration-resistant disease is important not only for overall survival (OS) but also for patients' quality of life. Darolutamide plus androgen-deprivation therapy (ADT) with docetaxel improved OS versus ADT and docetaxel in patients with mHSPC. The ARANOTE trial evaluated darolutamide and ADT without chemotherapy in patients with mHSPC.

Safety and tolerability of long-term treatment with darolutamide in patients with metastatic castration-resistant prostate cancer.

Background: In patients with metastatic castration-resistant prostate cancer, darolutamide was well tolerated for 25 months, but minimal long-term safety data are available.

Methods: Treatment-emergent adverse events (TEAEs) for patients receiving darolutamide for a median of 38 months (n = 13) are described in this pooled analysis of individual patient data from phase 1/2 studies.

Results: All patients reported TEAEs (mostly grade 1/2).

Efficacy and safety outcomes of darolutamide in patients with non-metastatic castration-resistant prostate cancer with comorbidities and concomitant medications from the randomised phase 3 ARAMIS trial.

Purpose: In patients with non-metastatic castration-resistant prostate cancer (nmCRPC) in the Androgen Receptor Antagonizing Agent for Metastasis-free Survival (ARAMIS) trial, darolutamide significantly improved median metastasis-free survival by nearly 2 years and reduced the risk of death by 31% versus placebo, with a favourable safety/tolerability profile. This post hoc analysis of ARAMIS evaluated efficacy and safety in patients by number of comorbidities and concomitant medications.

Methods: Patients with nmCRPC were randomised 2:1 to darolutamide (n = 955) or placebo (n = 554) while continuing androgen-deprivation therapy.

Effect of different low doses of intrathecal morphine (0.1 and 0.2 mg) on pain and vital functions in patients undergoing total hip arthroplasty: a randomised controlled study.

Background: Orthopaedic surgeries are among the most painful procedures. By adding low-dose morphine to intrathecal bupivacaine for spinal anaesthesia, the analgesic effect can be improved. The objeсtive of the study was tо compare the efficacy and safety of lоw-dоse (0.

Rhythm monitoring, success definition, recurrence, and anticoagulation after atrial fibrillation ablation: results from an EHRA survey.

Atrial fibrillation (AF) is a major challenge for the healthcare field. Pulmonary vein isolation is the most effective treatment for the maintenance of sinus rhythm. However, clinical endpoints for the procedure vary significantly among studies.

Overview of the current role of stereotactic body radiotherapy in the treatment of unfavorable intermediate- and high-risk prostate cancer.

Stereotactic body radiotherapy (SBRT) is well accepted for low- and intermediate-favorable risk prostate cancer. Available evidence about the application of SBRT in unfavorable- and high-risk prostate cancer is less solid. During last year's multiple variations in treatment, techniques have been reported making comparisons more complicated.

Contemporary clinical management of monomorphic idiopathic premature ventricular contractions: results of the European Heart Rhythm Association survey.

On behalf of the European Heart Rhythm Association, we designed a survey, whose aim was to understand the trend(s) in the clinical management of idiopathic monomorphic premature ventricular contractions (PVCs) among European cardiologists and cardiac electrophysiologists. A total of 202 participants in the survey answered 27 multiple-choice questions on the clinical presentation, diagnosis and treatment of idiopathic monomorphic PVCs. The most common symptom in patients with idiopathic monomorphic PVCs is palpitations, according to the majority of responders (87%), followed by fatigue (29%) and dizziness (18%).

Antithrombotic treatment management in low stroke risk patients undergoing cardioversion of atrial fibrillation <48 h duration: results of an EHRA survey.

Data supporting the safety of cardioversion (CV) of atrial fibrillation (AF) without anticoagulation in patients with AF duration <48 h are scarce. Observational studies suggest that the risk of stroke in these patients is very low when the definite duration of the AF episode is of <48 h and the clinical risk profile as estimated through the CHA2DS2VASc score is low (a score of 0 for men and 1 for women). As the recent 2020 European Society of Cardiology (ESC) guidelines indication for this clinical scenario is based mainly on consensus, we sent out a survey to assess the current clinical practice on anticoagulation prior to and post-CV in patients with AF <24-48 h duration and low stroke risk across centres in Europe.

Venous outcomes at 1 year after using the femoral vein as a conduit for passage of percutaneous femoropopliteal bypass.

Objective: The DETOUR 1 study was performed to assess the safety of the femoral vein as a "pass through" conduit for covered stent placement during fully percutaneous femoropopliteal bypass, also known as the DETOUR procedure.

Methods: At eight participating centers in this prospective, single-arm, international trial, 78 patients (82 femoropopliteal lesions) were enrolled. All patients had patent femoral veins measuring ≥10 mm in diameter at baseline.

Catheter ablation or medical therapy to delay progression of atrial fibrillation: the randomized controlled atrial fibrillation progression trial (ATTEST).

Aims: Delay of progression from paroxysmal to persistent atrial fibrillation (AF) is an important measure of long-term success of AF treatment. However, published data on the impact of catheter ablation on AF progression are limited. This study evaluates whether radiofrequency (RF) catheter ablation delays the progression of AF compared with antiarrhythmic drug (AAD) treatment using current AF management guidelines.

Upadacitinib placebo or adalimumab with background methotrexate in patients with rheumatoid arthritis and an inadequate response to methotrexate: a subgroup analysis of a phase III randomized controlled trial in Central and Eastern European patients.

Background: In the randomized, phase III, global SELECT-COMPARE study, upadacitinib 15 mg demonstrated efficacy at week 12 placebo and adalimumab with methotrexate (MTX) in patients with rheumatoid arthritis and inadequate response to MTX, which was maintained over 48 weeks. This post hoc analysis of SELECT-COMPARE reports the efficacy and safety of upadacitinib in Central and Eastern European (CEE) patients.

Methods: Patients were randomized 2:2:1 to upadacitinib 15 mg once daily, placebo, or adalimumab 40 mg every other week, and continued MTX.

European minimum standards for obstetric analgesia and anaesthesia departments: An experts' consensus.

: An important variability of anaesthetic standards of care was discovered in the obstetric departments of many European Union countries. After discussing this issue in various meetings of the European Society of Anaesthesiology (ESA) board and its obstetric subcommittee, European Board of Anaesthesiology of the European Union of Medical Specialists (EBA-UEMS) executive members, ESA obstetric subcommittee members and European experts in obstetric anaesthesiology have participated in the elaboration of this document. This experts' opinion is focused mainly on obstetric patients and safety concerns in terms of minimum standards of practice.

One-year results from the DETOUR I trial of the PQ Bypass DETOUR System for percutaneous femoropopliteal bypass.

Objective: The objective of this study was to evaluate the 1-year safety and effectiveness outcomes associated with the PQ Bypass DETOUR System (PQ Bypass, Milpitas, Calif) for the percutaneous bypass of long-segment femoropopliteal occlusive disease.

Methods: This prospective, single-arm, multicenter trial enrolled patients with long-segment femoropopliteal arterial disease. The DETOUR System percutaneously deploys modular stent grafts to bypass femoropopliteal lesions through a transvenous route.

Long-Term Outcome of Cataract Surgery in Eyes with Pseudoexfoliation Syndrome Associated with Weak Zonules: A Case Report.

A cataract surgery in both eyes was scheduled for an 81-year-old female patient. However, ophthalmic examination revealed marked iridodonesis, phacodonesis and pseudoexfoliative material on the surface of the lens in both eyes indicating weak zonules caused by pseudoexfoliation syndrome, which was more pronounced in the left eye. Cataract surgery was performed initially in the left eye by phacoemulsification.

Retraining for prevention of peritonitis in peritoneal dialysis patients: A randomized controlled trial.

Background: Peritonitis is more common in peritoneal dialysis (PD) patients nonadherent to the PD exchange protocol procedures than in compliant patients. We therefore investigated whether regular testing of PD knowledge with focus on infection prophylaxis could increase the time to first peritonitis (primary outcome) and reduce the peritonitis rate in new PD patients.

Methods: This physician-initiated, open-label, parallel group trial took place at 57 centers in Sweden, Denmark, Norway, Finland, Estonia, Latvia, the Netherlands, and the United Kingdom from 2010 to 2015.

Deletions in metastatic colorectal cancer with chromothripsis.

Aim: In our previously reported study, we found a correlation between DNA massive fragmentation and increased progression free survival (PFS) in metastatic colorectal cancer (mCRC), but not overall survival. The aim of this study is to find overlapping deleted genome regions in selected mCRC patients with chromothripsis and detect possible cause of increased PFS, and find new genes or combinations, involved in colorectal cancer oncogenesis. Materials and Methods: 10 mCRC patients with chromothripsis receiving 5-fluorouracil, oxaliplatin, leucovorin (FOLFOX) first-line palliative chemotherapy between August, 2011 and October, 2012 were selected for this study.

Diagnosis and management of left atrial appendage thrombus in patients with atrial fibrillation undergoing cardioversion or percutaneous left atrial procedures: results of the European Heart Rhythm Association survey.

Practices regarding indications and timing for transoesophageal echocardiography (TOE) before cardioversion (CV) of atrial fibrillation (AF) or left atrial (LA) interventional procedures, and preferred imaging techniques and pharmacotherapy, in cases of thrombus resistant to chronic oral anticoagulation (OAC) treatment, are largely unknown. The European Heart Rhythm Association (EHRA) conducted a survey to capture contemporary clinical practice in those areas of AF care. A 22-item online questionnaire was developed and distributed among the EHRA electrophysiology research network centres.

ODM-204, a Novel Dual Inhibitor of CYP17A1 and Androgen Receptor: Early Results from Phase I Dose Escalation in Men with Castration-resistant Prostate Cancer.

Background: Most prostate cancer patients develop castration-resistant prostate cancer (CRPC) after androgen deprivation therapy treatment. CRPC growth is mediated mostly by androgen receptor signalling driven by primary androgens synthesised largely by the CYP17A1 enzyme.

Objective: To evaluate the safety profile and dose-limiting toxicities of ODM-204.

Anterior capsulorhexis opening reduction after cataract surgery with subluxated lenses.

Background And Objective: This study sought to evaluate anterior capsulorhexis opening (ACO) reductions after surgery for a subluxated lens. Significant reduction of an ACO supports direct zonular involvement (capsular factors excluded by use of capsular tension rings [CTRs] and modern intraocular lens [IOLs]), and these findings question the long-term efficacy of subluxated lens surgery by means of cataract surgery. A small ACO due to lens mobility, non-enlargement of the ACO, and no lens epithelial cell washing due to an additional risk of further zonular damage were left as additional features to evaluate the possible outcomes of this simplified but still complicated surgery.

A randomized, multi-center, prospective study comparing best medical treatment versus best medical treatment plus renal artery stenting in patients with hemodynamically relevant atherosclerotic renal artery stenosis (RADAR) - one-year results of a pre-maturely terminated study.

Background: The indications for conservative "best medical treatment" (BMT) versus additional renal artery stenting are a matter of ongoing debate. The RADAR study aimed to evaluate the impact of percutaneous renal artery stenting on the impaired renal function in patients with hemodynamically significant atherosclerotic renal artery stenosis (RAS).

Methods: RADAR is an international, prospective, randomized (1:1) controlled study comparing BMT alone versus BMT plus renal artery stenting in patients with duplex sonographic hemodynamically relevant RAS.

Corrigendum to "Regional variations in baseline characteristics of cardiac rhythm device recipients: The PANORAMA observational cohort study" [Int. J. Cardiol. Heart Vessels (2014) 90-96].

[This corrects the article DOI: 10.1016/j.ijchv.

Regional variations in baseline characteristics of cardiac rhythm device recipients: The PANORAMA observational cohort study.

Background: The PANORAMA study was designed to collect concurrent data on subjects from different worldwide regions implanted with CRM devices.

Methods: In this prospective, multi-center study, we analyzed baseline data on 8586 subjects implanted with CRM devices with no additional selection criteria (66% pacemaker (IPG), 16% implantable cardiac defibrillators (ICD), 17% cardiac resynchronization therapy (CRT) and < 1% Internal Loop Recorder) from 156 hospitals across 6 geographical regions between 2005 and 2011.

Results: Regardless of the device implanted, subjects from the Middle East and India often had more diabetes than other regions.