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(1) Background: Unclear sonographic findings without adequate specialist expertise in abdominal ultrasound (AU) may harm patients in rural areas, due to overlooked diagnoses, unnecessary additional imaging (e.g., CT scan), and/or patient transport to referral expert centers. Appropriate telemedical sonography assistance could lead to corresponding savings. (2) Methods: The study was designed as a randomized trial. Selected study centers performed AU with the best local expertise. Patients were selected and monitored according to the indication that they required AU. The study depicted three basic scenarios. Group 1 corresponds to the telemedically assisted cohort, group 2 corresponds to the non-telemedically assisted cohort, and group 3 corresponds to a telemedically supported cohort for teaching purposes. The target case number of all three groups was 400 patients (20 calculated dropouts included). (3) Discussion: This study might help to clarify whether telemedicine-assisted ultrasound by a qualified expert is non-inferior to presence sonography concerning technical success and whether one of the interventions is superior in terms of efficacy and safety in one or more secondary endpoints. Randomization was provided, as every patient who needed an AU was included and then randomized to one of the groups. The third group consisted of a lower number of patients who were selected from group 1 or 2 for teaching purposes in case of rare diseases or findings. (4) Conclusions: The study investigates whether there are benefits of telemedical ultrasound for patients, medical staff, and the health care system.

Background: There are ongoing concerns regarding the use of bone graft following prosthetic joint infection and subsequent implant subsidence. The aim of this study was to determine whether the use of a cemented stem combined with femoral impaction bone grafting (FIBG) at second stage revision for infection results in stable femoral stem fixation, determined by accurate methods, and good clinical results., Methods: A prospective cohort of 29 patients underwent staged revision total hip arthroplasty for infection using an interval prosthesis followed by FIBG at the final reconstruction. The mean follow-up was 89 months (range, 8 to 167 months). Femoral implant subsidence was measured with radiostereometric analysis. Clinical outcomes included the Harris Hip Score, Harris Pain score and Société Internationale de Chirurgie Orthopédique et de Traumatologie activity scores., Results: At 2-years follow-up the median stem subsidence relative to femur was -1.36 mm (range, -0.31 to -4.98), while the cement subsidence relative to femur was -0.05 mm (range, 0.36 to -0.73). At 5-years follow-up, the median stem subsidence relative to femur was -1.89 mm (range, -0.27 to -6.35), while the cement subsidence relative to femur was -0.06 mm (range, 0.44 to -0.55). There were 25 patients who were confirmed infection-free after the second stage revision with FIBG. The median Harris Hip Score improved from 51 pre-operatively to 79 at 5 years (P = .0130), and Harris Pain score from 20 to 40 (P = .0038)., Conclusions: Stable femoral component fixation can be achieved with FIBG when reconstructing the femur after revision for infection without compromising infection cure rates and patient-reported outcomes., (Crown Copyright © 2023. Published by Elsevier Inc. All rights reserved.)

Periprosthetic joint infection (PJI) is a serious complication of total hip arthroplasty. Staged revision surgery is considered effective in eradicating PJI. We aimed to determine the rate of infection resolution after each stage of staged revision surgery (first stage, repeat first stage, second stage, excision arthroplasty, and reimplantation) and to assess functional outcomes and the mortality rate at ten years in a consecutive series of 30 chronic PJI of total hip arthroplasties. Infection resolution was defined as no clinical nor laboratory evidence of infection at 24 months after the last surgery and after a minimum of 12 months following cessation of antimicrobial treatment. Four patients died within 24 months of their final surgery. Nineteen patients, 73% (worst-case analysis (wca) 63%), were infection free after 1 surgery; 22 patients, 85% (wca 73%), were infection free after 2 surgeries; and 26 patients, 100% (wca 87%), were infection free after three and four surgeries. The median Harris Hip Score was 41 prior to first revision surgery and improved to 74 at twelve months and 76 at ten years after the final surgery. Thirteen patients died at a mean of 64 months from first revision, giving a mortality rate of 43% at ten years, which is approximately 25% higher than that of an age-matched general population. The results show that with repeated aggressive surgical treatment, most PJIs of the hip are curable. Ten years after successful treatment of PJI, functional outcomes and pain are improved and maintained compared to before initial surgery, but this must be balanced against the high 10-year mortality. Level of evidence: cohort studies.

Background: The Bernese periacetabular osteotomy (PAO) is a complex surgical procedure with a substantial learning curve. Although larger hospital and surgeon procedure volumes have recently been associated with a lower risk of complications, in geographically isolated regions, some complex operations such as PAO will inevitably be performed in low volume. A continuous structured program of distant mentoring may offer benefits when low numbers of PAOs are undertaken, but this has not been tested. We sought to examine a structured, distant-mentorship program of a low-volume surgeon in a geographically remote setting., Questions/purposes: The purposes of this study were (1) to identify the clinical results of PAO performed in a remote-mentorship program, as determined by patient-reported outcome measures and complications of the surgery; (2) to determine radiographic results, specifically postoperative angular corrections, hip congruity, and progression of osteoarthritis; and (3) to determine worst-case analysis of PAO survivorship, defined as nonconversion to THA, in a regionally isolated cohort of patients with a high rate of followup., Methods: Between August 1992 and August 2016, 85 PAOs were undertaken in 72 patients under a structured, distant-mentorship program. The patients were followed for a median of 5 years (range, 2-25 years). There were 18 males (21 hips) and 54 females (64 hips). The median age of the patients at the time of surgery was 26 years (range, 14-45 years). One patient was lost to followup (two PAOs) and one patient died as a result of an unrelated event. Patient-reported outcome measures and complications were collected through completion of patient and doctor questionnaires and clinical examination. Radiographic assessment of angular correction, joint congruity, and osteoarthritis was undertaken using standard radiology software. PAO survivorship was defined as nonconversion to THA and is presented using worst-case analysis. The loss-to-followup quotient-number of patients lost to followup divided by the number of a patients converted to THA-was calculated to determine quality of followup and reliability of survivorship data., Results: The median preoperative Harris hip scores of 58 (range, 20-96) improved postoperatively to 78 (range, 33-100), 86 (range, 44-100), 87 (range, 55-97), and 80 (range, 41-97) at 1, 5, 10, and 14 years, respectively. Sink Grade III complications at 12 months included four relating to the PAO and one relating to the concomitant femoral procedure. The median lateral center-edge angle correction achieved was 22° (range, 3°-50°) and the median correction of acetabular index was 19° (range, 3°-37°). Osteoarthritis progressed from a preoperative mean Tönnis grade of 0.6 (median, 1; range, 0-2) to a postoperative mean of 0.9 (median, 1; range, 0-3). Six hips underwent conversion to THA: five for progression of osteoarthritis and one for impingement. At 12-year followup, survivorship of PAO was 94% (95% confidence interval [CI], 85%-98%) and survivorship with worst-case analysis was 90% (95% CI, 79%-96%). The loss-to-followup quotient for this study was low, calculated to be 0.3., Conclusions: When PAO is performed using a structured process of mentoring under the guidance of an expert, one low-volume surgeon in a geographically isolated region achieved good patient-reported outcomes, a low incidence of complications at 12 months, satisfactory radiographic outcomes, and high survivorship. A structured distant-mentorship program may be a suitable method for initially learning and continuing to perform low-volume complex surgery in a geographically isolated region., Level of Evidence: Level IV, therapeutic study.

Background: Liver transplantation (LTx) is a potentially curative treatment option for hepatocellular carcinoma (HCC) in cirrhosis. However, patients, where HCC is already a systemic disease, LTx may be individually harmful and has a negative impact on donor organ usage. Thus, there is a need for improved selection criteria beyond nodule morphology to select patients with a favorable outcome for LTx in multifocal HCC. Evolutionary distance measured from genome-wide single-nucleotide polymorphism data between tumor nodules and the cirrhotic liver may be a prognostic marker of survival after LTx for multifocal HCC., Methods: In a retrospective multicenter study, clinical data and formalin-fixed paraffin-embedded specimens of the liver and 2 tumor nodules were obtained from explants of 30 patients in the discovery and 180 patients in the replication cohort. DNA was extracted from formalin-fixed paraffin-embedded specimens followed by genome wide single-nucleotide polymorphism genotyping., Results: Genotype quality criteria allowed for analysis of 8 patients in the discovery and 17 patients in the replication set. DNA concentrations of a total of 25 patients fulfilled the quality criteria and were included in the analysis. Both, in the discovery (P = 0.04) and in the replication data sets (P = 0.01), evolutionary distance was associated with the risk of recurrence of HCC after transplantation (combined P = 0.0002). In a univariate analysis, evolutionary distance (P = 7.4 × 10) and microvascular invasion (P = 1.31 × 10) were significantly associated with survival in a Cox regression analysis., Conclusions: Evolutionary distance allows for the determination of a high-risk group of recurrence if preoperative liver biopsy is considered.

Background: Patients receiving direct-acting, non-vitamin K oral anticoagulants (NOAC) frequently undergo gastrointestinal endoscopies (GIE) but little is known on the management and outcome of these interventions., Methods: With use of data from an ongoing, prospective, noninterventional registry of NOAC patients, the management and outcome of GIE were evaluated with use of standard event definitions. Patients undergoing GIE were categorized into two subgroups: (1) scheduled GIE (scheduled appointment, no acute bleeding) and (2) unscheduled GIE (unscheduled including management of acute gastrointestinal bleeding). The rates of major bleeding complications, cardiovascular complications, and all-cause death within 30 days after the procedure were evaluated., Results: Between October 1, 2011, and March 31, 2015, 492 patients underwent a total of 713 GIE (44.5% gastroscopies, 53.0% colonoscopies, 2.5% endoscopic retrograde cholangiopancreatography procedures), with 70.0% being scheduled procedures and 30.0% being unscheduled procedures. Endoscopies were performed within 24 h after the last NOAC intake in 45 of 713 cases (6.3%), between 24 and 48 h after the last intake in 336 cases (47.1%), and after NOAC therapy interruption for more than 48 h in 213 cases (29.9%). Heparin bridging therapy was used in 180 of 713 procedures (25.3%) and predominantly (170/180; 94.4%) in cases of NOAC therapy interruption for longer than 72 h. Until day 30 after the procedure, the event rates were 1.4% for cardiovascular events and 0.7% for major bleeding events., Conclusion: Continuation or short-term interruption of NOAC therapy seems to be a safe strategy for GIE. Heparin bridging therapy is predominantly used in cases of prolonged NOAC therapy interruption.

Background: Non-vitamin K dependent oral anticoagulants (NOACs) significantly decrease overall major bleeding rates compared with vitamin K antagonists (VKAs) but there is conflicting evidence regarding the relative risk of gastrointestinal bleeding. Since data regarding the types, the management, and the outcome of NOAC-associated gastrointestinal bleeding are scarce, we aimed to fill this gap by comparing cases of gastrointestinal bleeding associated with NOAC, VKA, or antiplatelet therapy., Methods: All major gastrointestinal bleeding events documented in the prospective Dresden NOAC registry were identified, and bleeding location, lesion type, endoscopic treatment, use of blood and coagulation factor transfusion, length of stay, and in-hospital mortality were compared with historical data from a large cohort of consecutive gastrointestinal bleeding patients., Results: In the 143 NOAC therapy cases, upper gastrointestinal tract bleeding was seen in 44.1%, lower gastrointestinal tract bleeding was seen in 42.0%, and no lesion could be identified in the remaining 14.0%. In contrast, upper gastrointestinal tract bleeding was commoner in the 185 VKA therapy cases (53.0%) and in the 711 antiplatelet therapy cases (68.1%). Among cases with upper gastrointestinal tract bleeding during VKA or antiplatelet therapy, 54.1% and 61.4% respectively presented with ulcers, compared with 27.0% for NOAC therapy. In contrast, hemorrhoid bleeding was the predominant lesion type for lower gastrointestinal tract bleeding with NOAC therapy, with a rate of 33.3%, compared with 10.6% with VKA therapy and 8.7% with antiplatelet therapy. NOAC-associated gastrointestinal bleeding resulted in comparatively low resource consumption, shorter hospitalization, and low in-hospital mortality (1.6%) compared with gastrointestinal bleeding historically seen with use of VKAs (in-hospital mortality 5.6%) or antiplatelet agents (in-hospital mortality 11.9%)., Conclusions: Gastrointestinal bleeding in NOAC recipients is different from that seen with VKA or antiplatelet therapy and has a better short-term prognosis.

Atrial fibrillation (AF) patients treated with well-controlled vitamin K antagonists (VKAs) may benefit less from non-vitamin K antagonist oral anticoagulants (NOACs) because they are supposed to be at low risk of thromboembolic and bleeding complications. However, little is known about the selection, management, and outcome of such "stable" VKA patients in current practice. We assessed characteristics, VKA persistence and 12 months' outcome of AF patients selected for VKA continuation. On March 1, 2013, the Dresden NOAC registry opened recruitment of patients continuing on VKA for sites that had been actively recruiting AF patients treated with NOACs in the prior 18 months. Patient characteristics were compared with those of NOAC patients from the same sites. Four hundred twenty-seven VKA patients had a significantly lower bleeding risk profile compared with 706 patients selected for NOAC treatment. For VKA, international normalised ratio time-in-therapeutic range before enrolment was 71 % and increased to 75 % during a mean follow-up of 15 months. Rates of stroke/transient ischaemic attack/systemic embolism were 1.3/100 patient-years (intention-to-treat) and 0.94/100 patient-years (as-treated). On-treatment rate of ISTH major bleeding was 4.15/100 patient-years (95 % CI 2.60-6.29) with a case-fatality rate of 16.3 % (all-cause mortality at day 90 after major bleeding). In conclusion, in daily care, AF patients selected for VKA therapy are healthier than those treated with NOAC, demonstrate a high quality of anticoagulant control and very low stroke rates. However, despite adequate patient selection and INR control, the risk of major VKA bleeding is unacceptably high and bleeding outcome is poor.

Anti-coagulated patients often undergo endoscopic procedures and non-vitamin-K-antagonist oral anticoagulants (NOAC) are increasingly prescribed. Consequently, a comprehensive knowledge about the adequate peri-interventional handling of these substances is required. A standardized approach needs to be planned for elective and emergency situations. As a result of their pharmacokinetics, the peri-endoscopic management of NOAC is relatively easy - an heparin "bridging"/"switching" is usually not required. In case of a severe NOAC bleeding endoscopic treatment must be considered at an early stage., (© Georg Thieme Verlag KG Stuttgart · New York.)

The effectiveness and safety of dabigatran for stroke prevention in atrial fibrillation (SPAF) demonstrated in RE-LY needs to be confirmed in daily care. To evaluate treatment persistence, effectiveness and safety of dabigatran therapy in SPAF patients in daily care, we used data from an ongoing, prospective, non-interventional registry of more than 2,500 patients on novel oral anticoagulants in daily care. Between October 1, 2011 and February 28, 2013, a total of 341 SPAF patients receiving dabigatran were enrolled. The combined endpoint of stroke/transient ischaemic attack/systemic embolism occurred at a rate of 2.93/100 patient-years in the intention-to-treat analysis (95%-CI 1.6-4.9) and at 1.9/100 patient-years in the on treatment analysis (events within three days after last intake). On-treatment rates were higher in patients selected for 110 mg dabigatran (n=183) BID compared to the 158 patients selected for 150 mg BID (2.88 [95% CI 1.16- 5.93] vs 0.86/100 patient-years [95% CI 0.10, 3.12]). On treatment, major bleeding occurred at a rate of 2.3/100 patient-years and numerically more often in patients receiving the 110 mg BID dose compared to the 150 mg BID dose (2.9 vs 1.7/100 patient-years). Dabigatran treatment discontinuation occurred in a total of 124 patients during follow-up (25.8 per 100 patient-years in Kaplan Meier analysis). Main reasons for treatment discontinuation were non-bleeding side effects. Our data contribute to the confirmation of effectiveness and relative safety of dabigatran in unselected patients in daily care. However, discontinuation rates are not lower than those reported for patients treated with vitamin K antagonists.

Worldwide, rivaroxaban is increasingly used for stroke prevention in atrial fibrillation and treatment of venous thromboembolism, but little is known about rivaroxaban-related bleeding complications in daily care. Using data from a prospective, noninterventional oral anticoagulation registry of daily care patients (Dresden NOAC registry), we analyzed rates, management, and outcome of rivaroxaban-related bleeding. Between October 1, 2011, and December 31, 2013, 1776 rivaroxaban patients were enrolled. So far, 762 patients (42.9%) reported 1082 bleeding events during/within 3 days after last intake of rivaroxaban (58.9% minor, 35.0% of nonmajor clinically relevant, and 6.1% major bleeding according to International Society on Thrombosis and Haemostasis definition). In case of major bleeding, surgical or interventional treatment was needed in 37.8% and prothrombin complex concentrate in 9.1%. In the time-to-first-event analysis, 100-patient-year rates of major bleeding were 3.1 (95% confidence interval 2.2-4.3) for stroke prevention in atrial fibrillation and 4.1 (95% confidence interval 2.5-6.4) for venous thromboembolism patients, respectively. In the as-treated analysis, case fatality rates of bleeding leading to hospitalizations were 5.1% and 6.3% at days 30 and 90 after bleeding, respectively. Our data indicate that, in real life, rates of rivaroxaban-related major bleeding may be lower and that the outcome may at least not be worse than that of major vitamin K antagonist bleeding, and probably better. This trial was registered at www.clinicaltrials.gov as identifier #NCT01588119., (© 2014 by The American Society of Hematology.)

Introduction: The relationship of circulating levels of receptor activator of nuclear factor-kappaB ligand (RANKL) and osteoprotegerin (OPG) with the expression of these molecules in bone has not been established. The objective of this study was to measure, in humans, the serum levels of RANKL and OPG, and the corresponding levels in bone of mRNA encoding these proteins., Methods: Fasting blood samples were obtained on the day of surgery from patients presenting for hip replacement surgery for primary osteoarthritis (OA). Intraoperatively, samples of intertrochanteric trabecular bone were collected for analysis of OPG and RANKL mRNA, using real time RT-PCR. Samples were obtained from 40 patients (15 men with age range 50 to 79 years, and 25 women with age range 47 to 87 years). Serum total RANKL and free OPG levels were measured using ELISA., Results: Serum OPG levels increased over the age range of this cohort. In the men RANKL mRNA levels were positively related to age, whereas serum RANKL levels were negatively related to age. Again, in the men serum RANKL levels were inversely related (r = -0.70, P = 0.007) to RANKL mRNA levels. Also in the male group, RANKL mRNA levels were associated with a number of indices of bone structure (bone volume fraction relative to bone tissue volume, specific surface of bone relative to bone tissue volume, and trabecular thickness), bone remodelling (eroded surface and osteoid surface), and biochemical markers of bone turnover (serum alkaline phosphatase and osteocalcin, and urinary deoxypyridinoline)., Conclusion: This is the first report to show a relationship between serum RANKL and the expression of RANKL mRNA in bone.