Does socket liner material affect clinical outcomes in lower limb prosthesis users? Insights from a randomized control trial.

Among the noted disadvantages of prosthesis suspension by flexible liner is the increased rate of perspiration within the socket, which has the potential to cause discomfort, suspension issues, and tissue damage. In recent years, phase change material technology has been adopted for the use in prosthesis liners. These promise to improve temperature control and, consequently, reduce sweating. Previous work has demonstrated that this approach is effective in slowing the temperature increase at the limb-socket interface, but it was not clear how this would translate to clinical outcomes. This study had the aim to compare conventional and phase change material liners regarding prosthesis utilization, physical performance, and patient-reported outcome measures. A randomized double-blind cross-over study design with 6-month intervention periods was used. Of the 42 enrolled participants, only 50% completed the protocol. The high attrition was in large part because of the COVID-19 pandemic that started disrupting daily life and thereby the data collection midway through the study period. The findings indicate that the temperature control liners were, by trend, associated with better prosthesis utilization. The found effects did not reach the level of statistical significance, which is likely a result of the unduly reduced sample size.

Transcatheter aortic valve implantation using the SAPIEN 3 valve to treat aortic regurgitation: The French multicentre S3AR study.

BACKGROUND: Transcatheter aortic valve implantation now has a major role in the treatment of patients with severe aortic stenosis. However, evidence is scarce on its feasibility and safety to treat patients with pure aortic regurgitation. AIMS: We sought to evaluate the results of transcatheter aortic valve implantation using the balloon-expandable SAPIEN 3 transcatheter heart valve (Edwards Lifesciences, Irvine, CA, USA) in patients with pure aortic regurgitation on native non-calcified valves. METHODS: We conducted a retrospective and prospective French multicentre observational study. We included all patients with symptomatic severe pure aortic regurgitation on native non-calcified valves, contraindicated to or at high risk for surgical valve replacement, who underwent transcatheter aortic valve implantation using the SAPIEN 3 transcatheter heart valve. RESULTS: A total of 37 patients (male sex, 73%) with a median age of 81years (interquartile range 69-85years) were screened using transthoracic echocardiography and computed tomography and were included at eight French centres. At baseline, 83.8% of patients (n=31) had dyspnoea New York Heart Association class≥III. The device success rate was 94.6% (n=35). At 30days, the all-cause mortality rate was 8.1% (n=3) and valve migration occurred in 10.8% of cases (n=4). Dyspnoea New York Heart Association class≤II was seen in 86.5% of patients (n=32), and all survivors had aortic regurgitation grade≤1. At 1-year follow-up, all-cause mortality was 16.2% (n=6), 89.7% (n=26/29) of survivors were in New York Heart Association class≤II and all had aortic regurgitation grade≤2. CONCLUSION: Transcatheter aortic valve implantation using the SAPIEN 3 transcatheter heart valve seems promising to treat selected high-risk patients with pure aortic regurgitation on non-calcified native valves, contraindicated to surgical aortic valve replacement.

UK poSt Arthroplasty Follow-up rEcommendations (UK SAFE): what does analysis of linked, routinely collected national data sets tell us about mid-late term revision risk after hip replacement? Retrospective cohort study.

OBJECTIVE: To identify patients at risk of mid-late term revision of hip replacement to inform targeted follow-up. DESIGN: Analysis of linked national data sets from primary and secondary care (Clinical Practice Research Datalink (CPRD-GOLD); National Joint Registry (NJR); English Hospital Episode Statistics (HES); Patient-Reported Outcome Measures (PROMs)). PARTICIPANTS: Primary elective total hip replacement (THR) aged≥18. EVENT OF INTEREST: Revision surgery≥5 years (mid-late term) after primary THR. STATISTICAL METHODS: Cox regression modelling to ascertain risk factors of mid-late term revision. HR and 95% CI assessed association of sociodemographic factors, comorbidities, medication, surgical variables and PROMs with mid-late term revision. RESULTS: NJR-HES-PROMs data were available from 2008 to 2011 on 142 275 THR; mean age 70.0 years and 61.9% female. CPRD GOLD-HES data covered 1995-2011 on 17 047 THR; mean age 68.4 years, 61.8% female. Patients had minimum 5 years postprimary surgery to end 2016. In NJR-HES-PROMS data, there were 3582 (2.5%) revisions, median time-to-revision after primary surgery 1.9 years (range 0.01-8.7), with 598 (0.4%) mid-late term revisions; in CPRD GOLD, 982 (5.8%) revisions, median time-to-revision 5.3 years (range 0-20), with 520 (3.1%) mid-late term revisions.Reduced risk of mid-late term revision was associated with older age at primary surgery (HR: 0.96; 95% CI: 0.95 to 0.96); better 6-month postoperative pain/function scores (HR: 0.35; 95% CI: 0.27 to 0.46); use of ceramic-on-ceramic (HR: 0.73; 95% CI: 0.56 to 0.95) or ceramic-on-polyethylene (HR: 0.76; 95% CI: 0.58 to 1.00) bearing surfaces.Increased risk of mid-late term revision was associated with the use of antidepressants (HR: 1.32; 95% CI: 1.09 to 1.59), glucocorticoid injections (HR: 1.33; 95% CI: 1.06 to 1.67) and femoral head size≥44 mm (HR: 2.56; 95% CI: 1.09 to 6.02)No association of gender, obesity or Index of Multiple Deprivation was observed. CONCLUSION: The risk of mid-late term THR is associated with age at primary surgery, 6-month postoperative pain and function and implant factors. Further work is needed to explore the associations with prescription medications observed in our data.

Impact of microprocessor prosthetic knee on mobility and quality of life in patients with lower limb amputation: a systematic review of the literature.

INTRODUCTION: Advanced technologies have made available the development of microprocessor prosthetic knee (MPK) to improve autonomy of patients with lower limb amputation. In the present systematic review, we aimed to evaluate the impact of the use of all types of MPK on patients' functional status and quality of life. EVIDENCE ACQUISITION: We conducted this review according to the PRISMA Guidelines on Medline (via Ovid), Scopus and SportDiscuss. All identified articles were screened for their eligibility by two reviewers using Covidence software. The Cochrane Risk of Bias (RoB) or the NIH Quality Assessment Tool were used to assess the quality of the studies. EVIDENCE SYNTHESIS: Eighteen articles were included in the present review (7 randomized controlled trials - RCT), 6 cross-sectional and 5 follow-up studies). Number of participants included varied from 20 to 602, protocols' length varied from a single session to 12 weeks of use of MPK. Taken together, MPK users compared to NMPK users tend to present better functional status and mobility. Quality of life was also positively impacted in MPK users. On the other hand, the superiority of more advanced MPKs such as the Genium® is less clear, especially given the improvements over time of other MPKs such as the C-leg® and the Rheo knee®. CONCLUSIONS: Based on our results, while it is clear that MPKs outperform NMPKs both for functional status and quality of life, additional benefits of one MPK over another is less clear. Future studies are needed to clarify these aspects.

Gore Cardioform ASD device thrombus weeks after COVID-19 infection.

Device-related thrombosis and device-related endocarditis after atrial septal defect (ASD) transcatheter closure are extremely rare. It is known that COVID-19 infection could lead to a thrombotic microangiopathy-like phenomenon. We present the case of a 14-year-old female who developed fever and was found to have a thrombus on the right atrial side of the ASD closure device weeks after an asymptomatic COVID-19 infection and negative COVID-19 test 2 days before transcatheter ASD closure. Although there is no certainty that the thrombus was related to the prior COVID-19 infection, the possibility of an ongoing COVID-19-related hypercoagulable state should be entertained.

The Use of Smartphone Photogrammetry to Digitise Transtibial Sockets: Optimisation of Method and Quantitative Evaluation of Suitability.

The fit of a lower limb prosthetic socket is critical for user comfort and the quality of life of lower limb amputees. Sockets are conventionally produced using hand-crafted patient-based casting techniques. Modern digital techniques offer a host of advantages to the process and ultimately lead to improving the lives of amputees. However, commercially available scanning equipment required is often expensive and proprietary. Smartphone photogrammetry could offer a low cost alternative, but there is no widely accepted imaging technique for prosthetic socket digitisation. Therefore, this paper aims to determine an optimal imaging technique for whole socket photogrammetry and evaluate the resultant scan measurement accuracy. A 3D printed transtibial socket was produced to create digital and physical twins, as reference models. The printed socket was photographed from 360 positions and simplified genetic algorithms were used to design a series of experiments, whereby a collection of photos were processed using Autodesk ReCap. The most fit technique was used to assess accuracy. The accuracy of the socket wall volume, surface area and height were 61.63%, 99.61% and 99.90%, respectively, when compared to the digital reference model. The scanned model had a wall thickness ranging from 2.075 mm at the top to 7.758 mm towards the base of the socket, compared to a consistent thickness of 2.025 mm in the control model. The technique selected did not show sufficient accuracy for clinical application due to the degradation of accuracy nearer to the base of the socket interior. However, using an internal wall thickness estimation, scans may be of sufficient accuracy for clinical use; assuming a uniform wall thickness.

Hemodynamic differences by increasing low profile visualized intraluminal support (LVIS) stent local compaction across intracranial aneurysm orifice.

BACKGROUND: The Low-profile Visualized Intraluminal Support device (LVIS) has been successfully used to treat cerebral aneurysm, and the push-pull technique has been used clinically to compact the stent across aneurysm orifice. Our aim was to exhibit the hemodynamic effect of the compacted LVIS stent. METHODS: Two patient-specific aneurysm models were constructed from three-dimensional angiographic images. The uniform LVIS stent, compacted LVIS and Pipeline Embolization Device (PED) with or without coil embolization were virtually deployed into aneurysm models to perform hemodynamic analysis. Intra-aneurysmal flow parameters were calculated to assess hemodynamic differences among different models. RESULTS: The compacted LVIS had the highest metal coverage across the aneurysm orifice (case 1, 46.37%; case 2, 67.01%). However, the PED achieved the highest pore density (case 1, 19.56 pores/mm2; case 2, 18.07 pores/mm2). The compacted LVIS produced a much higher intra-aneurysmal flow reduction than the uniform LVIS. The PED showed a higher intra-aneurysmal flow reduction than the compacted LVIS in case 1, but the results were comparable in case 2. After stent placement, the intra-aneurysmal flow was further reduced as subsequent coil embolization. The compacted LVIS stent with coils produced a similar reduction in intra-aneurysmal flow to that of the PED. CONCLUSIONS: The combined characteristics of stent metal coverage and pore density should be considered when assessing the flow diversion effects of stents. More intra-aneurysmal flow reductions could be introduced by compacted LVIS stent than the uniform one. Compared with PED, compacted LVIS stent may exhibit a flow-diverting effect comparable to that of the PED.

Orthopedics and 3D technology in Turkey: A preliminary report.

OBJECTIVES: In this study, we present the use of case specific three-dimensional (3D) printed plastic models and custom-made acetabular implants in orthopedic surgery. MATERIALS AND METHODS: Between March 2018 and September 2020, surgeries were simulated using plastic models manufactured by 3D printers on the two patients with pilon fractures. Also, custom-made acetabular implants were used on two patients with an acetabular bone defect for the revision of total hip arthroplasty (THA). RESULTS: More comfortable surgeries were experienced in pilon fractures using preoperative plastic models. Similarly, during the follow-up period, the patients that applied custom-made acetabular implants showed a fixed and well-positioning in radiographic examination. These patients did not experience any surgical complications and achieved an excellent recovery. CONCLUSION: Preoperative surgical simulation with 3D printed models can increase the comfort of fracture surgeries. Also, custom-made 3D printed acetabular implants can perform an important task in patients treated with revision THA surgery due to severe acetabular defects.

COVID-19 infection with delayed presentation of infective endocarditis of the prosthetic pulmonary valve.

Pulmonary valve endocarditis after transcatheter pulmonary valve implantation has been an emerging concern due to the increasing prevalence of transcatheter placement of pulmonary valve in the treatment of residual right ventricular outflow tract stenosis or regurgitation. Pulmonary valve endocarditis is a dreadful complication of transcatheter pulmonary valve implantation that have been reported with Melody valve (Medtronic, Inc., Minneapolis, MN) and Edward Sapien valve (Edwards Life Sciences, Irvine, CA) till date. There are scanty available literatures for pulmonary valve endocarditis with Venus P valve (Venus Medtech, Hangzhou, China) implantation. Furthermore, cardiovascular comorbidity is common in COVID-19 infection with limited evidence of COVID-19 infection concomitant with infective endocarditis. This case happens to be the first reported case of infective endocarditis of pulmonary valve with concomitant COVID-19 infection and also delayed presentation of pulmonary valve endocarditis with Venus P valve implantation.

Effects of Simulated COVID-19 Cytokine Storm on Stent Thrombogenicity.

BACKGROUND: Cytokine storm-related hypercoagulation may be important in the pathogenesis of stent thrombosis in patients with SARS-CoV-2. Whether stent polymers behave differently under such conditions has never been explored. METHODS: Fluorinated polymer-nanocoated and uncoated COBRA stents (CeloNova), BioLinx-polymer-coated Resolute Onyx stents (Medtronic), and Synergy stents (Boston Scientific), which are abluminally coated with a bioabsorbable polymer, were exposed to human blood from healthy donors which was supplemented with 400 pg/mL IL-6 and 100 pg/mL TNF-α, similar to what is seen in cytokine storm caused by SARS-CoV-2. Platelet adhesion and neutrophil activation, assessed by immunofluorescence, were compared under cytokine storm and control conditions (untreated blood) (n = 4 experimental runs). RESULTS: Platelet adhesion values, defined as %platelet-covered area x staining intensity, were significantly lower in coated and uncoated COBRA and in Resolute Onyx than in Synergy under control conditions (1.28 × 107 ± 0.43 × 107 vs. 2.92 × 107 ± 0.49 × 107 vs. 3.57 × 107 ± 0.73 × 107 vs. 9.94 × 107 ± 0.99 × 107; p ≤0.0001). In cytokine storm, platelet adhesion values remained low in coated COBRA-PzF (1.78 × 107 ± 0.38 × 107) compared to all other devices (uncoated COBRA: 5.92 × 107 ± 0.96 × 107; Resolute Onyx: 7.27 × 107 ± 1.82 × 107; Synergy: 11.28 × 107 ± 1.08 × 107; p ≤ 0.0001). Although cytokine storm conditions significantly increased neutrophil activation in all stents, it was significantly less in coated and uncoated COBRA, and in Resolute Onyx than in Synergy. CONCLUSIONS: Blood-biomaterials interactions may determine the thrombogenic potential of stents. Under simulated cytokine storm conditions, fluoropolymer-coated stents showed the most favorable anti-thrombogenic and anti-inflammatory properties.

Current Controversies in Inferior Vena Cava Filter Placement: AJR Expert Panel Narrative Review.

Despite inferior vena cava (IVC) filter practice spanning over 50 years, interventionalists face many controversies in proper utilization and management. This article reviews recent literature and offers opinions on filter practices. IVC filtration is most likely to benefit patients at high risk of iatrogenic pulmonary embolus during endovenous intervention. Filters should be used selectively in patients with acute trauma or who are undergoing bariatric surgery. Retrieval should be attempted for perforating filter and fractured filter fragments when imaging suggests feasibility and favorable risk-to-benefit ratio. Antibiotic prophylaxis should be considered when removing filters with confirmed gastrointestinal penetration. Anticoagulation solely because of filter presence is not recommended except in patients with active malignancy. Anticoagulation while filters remain in place may decrease long-term filter complications in these patients. Patients with a filter and symptomatic IVC occlusion should be offered filter removal and IVC reconstruction. Physicians implanting filters may maximize retrieval by maintaining physician-patient relationships and scheduling follow-up at time of placement. Annual follow-up allows continued evaluation for removal or replacement as appropriate. Advanced retrieval techniques increase retrieval rates but require caution. Certain cases may require referral to experienced centers with additional retrieval resources. The views expressed should help guide clinical practice, future innovation, and research.

Treating diabetic all-comers with contemporary drug-eluting stents: Prespecified comparisons from the BIO-RESORT and the BIONYX randomized trials.

BACKGROUND: Patients with diabetes have more extensive coronary disease, resulting in higher risks of adverse clinical events following stenting. In all-comer patients, contemporary DES have shown excellent safety and efficacy, but data on diabetic patients are scarce. Separately for the BIO-RESORT and BIONYX trials, we assessed the 2-year clinical outcomes of diabetic patients, treated with various contemporary drug-eluting stents (DES). METHODS: We performed two prespecified secondary analyses of two randomized DES trials, which both stratified for diabetes. The main endpoint was target vessel failure (TVF), a composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization. Follow-up was finished before the COVID-19 pandemic. RESULTS: In BIO-RESORT, 624/3514 (17.8%) had diabetes: 211 received Orsiro sirolimus-eluting stents (SES), 203 Synergy everolimus-eluting stents (EES), and 210 Resolute Integrity zotarolimus-eluting stents (RI-ZES). TVF did not differ between SES (10.2%) and EES (10.0%) versus RI-ZES (12.7%) (SES vs. RI-ZES HR:0.78, 95%-CI [0.44-1.40]; p = 0.40, EES vs. RI-ZES HR:0.79, 95%-CI [0.44-1.40]; p = 0.42). In BIONYX, 510/2488 (20.5%) patients had diabetes: 250 received SES and 260 Resolute Onyx zotarolimus-eluting stents (RO-ZES). There was no difference in TVF between SES (10.7%) versus RO-ZES (12.2%) (HR:0.88, 95%-CI [0.52-1.48]; p = 0.63). CONCLUSIONS: There was no difference in 2-year clinical outcome among patients with diabetes, who were treated with SES, or EES, versus RI-ZES. In addition there was no difference in clinical outcome in diabetic patients, who were treated with SES versus RO-ZES. These findings may be considered as a signal of safety and efficacy of the studied DES in patients with diabetes.