Safety and effectiveness of bycross rotational atherectomy and aspiration device: a prospective, multi-center pre-market approval study.

Purpose: To demonstrate safety and effectiveness of the novel ByCross® atherectomy system for treatment of complex femorodistal > 80% arterial stenosis.

Materials And Methods: From September 2018 until April 2019 39 patients with 41 femorodistal lesions including the femoropopliteal and distal popliteal segments were treated in a prospective, nonrandomized pre-market approval study with 6 months follow up using the ByCross® atherectomy device (ClinicalTrials.gov identifier NCT03724279).

Exome sequencing of 20,979 individuals with epilepsy reveals shared and distinct ultra-rare genetic risk across disorder subtypes.

Identifying genetic risk factors for highly heterogeneous disorders like epilepsy remains challenging. Here, we present the largest whole-exome sequencing study of epilepsy to date, with >54,000 human exomes, comprising 20,979 deeply phenotyped patients from multiple genetic ancestry groups with diverse epilepsy subtypes and 33,444 controls, to investigate rare variants that confer disease risk. These analyses implicate seven individual genes, three gene sets, and four copy number variants at exome-wide significance.

Real-world data on cannabidiol treatment of various epilepsy subtypes: A retrospective, multicenter study.

Objective: Cannabidiol (CBD) is approved for treatment of Dravet syndrome (DS), Lennox-Gastaut syndrome (LGS), and tuberous sclerosis complex (TSC). Several studies suggest antiseizure effects also beyond these three epilepsy syndromes.

Methods: In a retrospective multicenter study, we analyzed the efficacy and tolerability of CBD in patients with epilepsy at 16 epilepsy centers.

Red Blood Cell Immunization and Contributing Factors in 685 Thalassemia Patients.

An analysis of red blood cell alloimmunization in patients with thalassemia can help to devise specific strategies to decrease the alloimmunization rate. This study explored the frequency and specificity of alloantibodies and autoantibodies against red blood cell (RBC) antigens in patients with thalassemia referring to the Iranian Blood Transfusion Organization (IBTO) Immunohematology Reference Laboratory (IRL) in Tehran. This study first examined the laboratory records of 23,113 patients suffering from different diseases referring to IBTO's IRL for pretransfusion testing in the 2008-2015 period.

Twelve-month efficacy of second-generation cryoballoon ablation for atrial fibrillation performed at community hospitals: results of the German register on cryoballoon ablation in local hospitals (regional).

Background: The 12-month follow-up (F/U) efficacy of CBA PVI performed at community hospitals for treatment of symptomatic paroxysmal and persistent atrial fibrillation (AF) is unknown. This study determined the 12-month efficacy of pulmonary vein isolation (PVI) using cryoballoon ablation (CBA) performed at community hospitals with limited annual case numbers.

Methods: This registry study included 983 consecutive patients (pts) from 19 hospitals, each with an annual procedural volume of < 100 PVI procedures/year.

Treatment of Infantile Spasm Syndrome: Update from the Interdisciplinary Guideline Committee Coordinated by the German-Speaking Society of Neuropediatrics.

Objectives: The manuscript serves as an update on the current management practices for infantile spasm syndrome (ISS). It includes a detailed summary of the level of current evidence of different treatment options for ISS and gives recommendations for the treatment and care of patients with ISS.

Methods: A literature search was performed using the Cochrane and Medline Databases (2014 to July 2020).

Trigeminal Rhizotomy Using Gyroscopic Radiosurgery: A Case Report.

Characterized by intense, episodic lancinating pain within the distribution of the trigeminal nerve, trigeminal neuralgia (TN) is the most common craniofacial pain syndrome. Failure of medical management requires the consideration of interventional procedures. Stereotactic radiosurgery (SRS) is one of the more commonly used surgical options.

The Supera Interwoven Nitinol Stent as a Flow Diverting Device in Popliteal Aneurysms.

Purpose: The feasibility of using a compressed interwoven Supera stent as a flow diverting device for popliteal aneurysms was recently demonstrated in patients. It is unclear, however, what the optimal flow diverting strategy is, because of the fusiform shape of popliteal aneurysms and their exposure to triphasic flow. To assess this flow diverting strategy for popliteal aneurysms, flow profiles and thrombus formation likelihood were investigated in popliteal aneurysm models.

[Predicting major bleeding events in patients with peripheral arterial disease: the OAC-PAD risk score].

Although patients with peripheral arterial disease (PAD) are at a high risk of major bleeding owing to their comorbidity and risk profile, no validated tools exist to predict bleeding risk. To make matters worse, several randomized and controlled trials have excluded patients who are at a high risk of bleeding. Using routine health insurance claims data and machine learning methods, a pragmatic prediction model was developed and internally validated.

Vitamin Supplementation and Dementia: A Systematic Review.

Background: Dementia is a syndrome characterized by progressive cognitive impairment that interferes with independent function in daily activities. Symptoms of dementia depend on its cause and vary greatly between individuals. There is extensive evidence supporting a relationship between diet and cognitive functions.

Distribution of Mobile Health Applications amongst Patients with Symptomatic Peripheral Arterial Disease in Germany: A Cross-Sectional Survey Study.

Background: Broadly available digital and mobile health applications (also known as mHealth) have recently gained increasing attention by the vascular community, but very little is known about the dissemination and acceptance of such technologies in certain target populations. The current study aimed to determine the user behaviour and acceptance of such digital technologies amongst patients with peripheral arterial disease (PAD).

Methods: A cross-sectional survey of consecutively treated inpatients at 12 university institutions, as well as one non-university institution, was conducted.

L-Serine Treatment is Associated with Improvements in Behavior, EEG, and Seizure Frequency in Individuals with GRIN-Related Disorders Due to Null Variants.

Pathogenic missense variants in GRIN2A and GRIN2B may result in gain or loss of function (GoF/LoF) of the N-methyl-D-aspartate receptor (NMDAR). This observation gave rise to the hypothesis of successfully treating GRIN-related disorders due to LoF variants with co-agonists of the NMDAR. In this respect, we describe a retrospectively collected series of ten individuals with GRIN2A- or GRIN2B-related disorders who were treated with L-serine, each within an independent n-of-1 trial.

Stents With Torsional Strength for Superficial Femoral Artery Disease: The Prospective Q3-Registry.

Purpose: This postmarketing surveillance study aimed to assess effectiveness and safety of a peripheral self-expanding stent with high torsional strength (POLARIS stent) for the treatment of de novo superficial femoral artery (SFA) lesions in the routine clinical practice.

Materials And Methods: Consecutive patients with symptomatic de novo SFA occlusive disease who underwent POLARIS stent implantation were enrolled into the prospective, multicenter, observational postmarket surveillance study. Primary outcome measure was freedom from clinically driven target lesion revascularization (cdTLR) at 12 months.

Effectiveness of an Annular Closure Device to Prevent Recurrent Lumbar Disc Herniation: A Secondary Analysis With 5 Years of Follow-up.

Importance: Patients with large annular defects following lumbar microdiscectomy for disc herniation are at increased risk for symptomatic recurrence and reoperation.

Objective: To determine whether a bone-anchored annular closure device in addition to lumbar microdiscectomy resulted in lower reherniation and reoperation rates vs lumbar microdiscectomy alone.

Design, Setting, And Participants: This secondary analysis of a multicenter randomized clinical trial reports 5-year follow-up for enrolled patients between December 2010 and October 2014 at 21 clinical sites.

Health-related quality of life in children and adolescents with tuberous sclerosis complex and their caregivers: A multicentre cohort study from Germany.

Objective: This study aimed to measure health-related quality of life (HRQOL) in children and adolescents with tuberous sclerosis complex (TSC) and quality of life (QOL) and depressive symptoms among caregivers.

Methods: Adequate metrics were used to assess HRQOL in children and adolescents with TSC (4-18 years, KINDL) as well as QOL (EQ-5D) and symptoms of depression (BDI-II) among caregivers. Predictors for reduced HRQOL and depressive symptoms were identified by variance analysis, ordinal regression, and bivariate correlation.

[Glecaprevir/Pibrentasvir + Sofosbuvir + Ribavirin as a salvage regimen after Sofosbuvir + Velpatasvir + Voxilaprevir re-treatment failure].

Antiviral therapy of chronic hepatitis C virus (HCV) achieves sustained virological response (SVR) in the majority of patients. Even after initial virological failure, re-treatment with the combination of sofosbuvir+velpatasvir+voxilaprevir (SOF/VEL/VOX) has been established as an effective second line regimen. However, some patients fail to achieve SVR after a second antiviral course with SOF/VEL/VOX.

Long-term efficacy, tolerability, and retention of brivaracetam in epilepsy treatment: A longitudinal multicenter study with up to 5 years of follow-up.

Objective: This study was undertaken to evaluate the long-term efficacy, retention, and tolerability of add-on brivaracetam (BRV) in clinical practice.

Methods: A multicenter, retrospective cohort study recruited all patients who initiated BRV between February and November 2016, with observation until February 2021.

Results: Long-term data for 262 patients (mean age = 40 years, range = 5-81 years, 129 men) were analyzed, including 227 (87%) diagnosed with focal epilepsy, 19 (7%) with genetic generalized epilepsy, and 16 (6%) with other or unclassified epilepsy syndromes.

Incidental occurrence of papillary renal cell carcinoma in the native kidney with autosomal dominant polycystic kidney disease after renal transplantation: A case report.

Autosomal dominant polycystic kidney disease (ADPKD) is one of the best-known genetic diseases. Almost half of the patients with ADPKD will develop end-stage renal disease, and the majority of patients are treated with renal transplantation. The current study presents a case that developed papillary renal cell carcinoma (PRCC) in the native right kidney 10 years after renal transplantation.

[Innovations in the endovascular treatment of peripheral arterial disease].

The cooperation of physicians, engineers and other sciences results in a steady launching of effective tools for vascular treatment, which further support the dominating position of endovascular therapy in the field of PAD. Parallel to the treatment options, non-radiation based image guidance is another area, where innovation helps to reduce radiation burden for patient and staff members without losing procedural quality and despite a growing number of radiation based procedures. Meanwhile, the available portfolio of endovascular tools allows to treat every vessel segment with results comparable to or even better then open surgery.

Efficacy, tolerability, and retention of fenfluramine for the treatment of seizures in patients with Dravet syndrome: Compassionate use program in Germany.

Objective: Dravet syndrome (DS) is a rare but severe drug-resistant epilepsy. Before the approval of fenfluramine (FFA) for the treatment of seizures in DS, patients in Germany could receive treatment under a compassionate use program (CUP).

Methods: We conducted a multicenter, retrospective, observational study to describe the efficacy, tolerability, and retention of FFA within the CUP.

Safety and acute efficacy of cryoballoon ablation for atrial fibrillation at community hospitals.

Aims: Pulmonary vein isolation (PVI) using cryoballoon ablation (CBA) is an established procedure for treating symptomatic paroxysmal and persistent atrial fibrillation (AF). The safety and efficacy of PVI performed at community hospitals are unknown. We aimed to determine the safety and acute efficacy of PVI using CBA performed at community hospitals with limited annual case numbers.

Cardiac Autonomic Nervous System and Ventricular Arrhythmias: The Role of Radionuclide Molecular Imaging.

Widely established compared to myocardial perfusion imaging, cardiac autonomous nervous system (CANS) assessment by radiopharmaceutical means is of potential use especially to arrhythmogenic diseases not correlated with anatomic or functional alterations revealed by classical imaging techniques. Molecular imaging of both pre- and postsynaptic functions of the autonomous nervous system is currently feasible, since single photon emission tomography (SPECT) and positron emission tomography (PET) have the ability to reveal the insights of molecular pathophysiology depicting both sympathetic and parasympathetic imbalance in discrete heart pathologies. This review provides not only a brief presentation of radiopharmaceuticals used for non-invasive CANS imaging in the case of ventricular arrhythmias, but also a current update on ventricular tachycardias, cardiomyopathies, Brugada and Long QT syndrome literature.

Patient assessment and feasibility of treatment in older patients with cancer: results from the IN-GHO Registry.

Purpose: Predicting feasibility of treatment in older patients with cancer is a major clinical task. The Initiative Geriatrische Hämatologie und Onkologie (IN-GHO) registry prospectively collected data on the comprehensive geriatric assessment (CGA), physician's and patient's-self assessment of fitness for treatment, and the course of treatment in patients within a treatment decision aged ≥ 70 years.

Patients And Methods: The registry included 3169 patients from 93 centres and evaluated clinical course and treatment outcomes 2-3 and 6 months after initial assessment.