Femoral Site Research Articles

Bioactive Scaffold Fabricated by 3D Printing for Enhancing Osteoporotic Bone Regeneration.

We develop a poly (lactic-co-glycolic acid)/β-calcium phosphate (PLGA/TCP)-based scaffold through a three-dimensional (3D) printing technique incorporating icaritin (ICT), a unique phytomolecule, and secretome derived from human fetal mesenchymal stem cells (HFS), to provide mechanical support and biological cues for stimulating bone defect healing. With the sustained release of ICT and HFS from the composite scaffold, the cell-free scaffold efficiently facilitates the migration of MSCs and promotes bone regeneration at the femoral defect site in the ovariectomy (OVX)-induced osteoporotic rat model. Furthermore, mechanism study results indicate that the combination of ICT and HFS additively activates the Integrin–FAK (focal adhesion kinase)–ERK1/2 (extracellular signal-regulated kinase 1/2)–Runx2 (Runt-related transcription factor 2) axis, which could be linked to the beneficial recruitment of MSCs to the implant and subsequent osteogenesis enhancement. Collectively, the PLGA/TCP/ICT/HFS (P/T/I/S) bioactive scaffold is a promising biomaterial for repairing osteoporotic bone defects, which may have immense implications for their translation to clinical practice.

Extravascular Access Artery Closure Following Percutaneous Peripheral Intervention

Percutaneous closure of the access artery following endovascular intervention has become commonplace. In patients with peripheral vascular disease, however, control of a femoral puncture site is problematic as the access artery is frequently plaque-laden and stenotic. Ischemic complications in the access extremity are more common in these cases, particularly when using devices requiring the deployment of prosthetic material within the compromised arterial lumen. The purpose of this retrospective clinical study was to assess the efficacy of totally extravascular/bioresorbable closure of femoral artery puncture sites following percutaneous peripheral intervention (PPI).

Real-world VASCADE closure device versus manual compression use and outcomes in patients with severe common femoral artery disease.

The VASCADE closure device deploys an extravascular collagen plug. Its use in those with access site disease undergoing peripheral vascular intervention (PVI) is unknown. We aimed to evaluate the efficacy and safety of the VASCADE closure device compared to manual compression (MC) in patients with moderate femoral access site disease. We performed a single-center, retrospective review of patients undergoing PVI with at least moderate access site disease. Our institutional database was linked to the Vascular Quality Initiative database, and 200 patients were selected from a 1:1 propensity-matched cohort. Data on procedural metrics and outcomes up to 30-days were abstracted. There were 103 procedures that used VASCADE and 97 used MC. Baseline variables were similar between groups. The mean age was 68.2 ± 11.2 years and 37.6% were women. Closing mean activated clotting time (ACT) was shorter in VASCADE (198 s VASCADE vs. 213 s MC; p = 0.018). There was a nonsignificant decrease in external compression device use with VASCADE (VASCADE 19.0% vs. MC 28.1%; p = 0.15). At 30-days, there was a nonsignificant reduction in hematoma with VASCADE (3.8% vs. 7.8% MC; p = 0.25) and no difference in retroperitoneal bleeding (0.5%). Pseudoaneurysm rate was similar (1.3% VASCADE vs. 1.7% MC; p = 0.79). The 30-day mortality rate was similar between the two groups and not related to the procedure (1.3% VASCADE vs. 0.9% MC; p = 0.79). In patients undergoing PVI with at least moderate access site disease, safety and efficacy after using VASCADE was comparable withMC.

Femoral artery: An Alternative Cannulation Localization in the Angiographic Treatment of Dysfunctional Arteriovenous Fistulas. Single Center Experience

Endovasküler girişimler, disfonksiyonel arteriovenöz fistüllerin (AVF) tedavisinde en sık kullanılan tedavi modaliteleri olsa da optimal ponksiyon yeri konusunda bir fikir birliği yoktur. Bu retrospektif, tek merkezli çalışmada, femoral arter yoluyla disfonksiyonel AVF'lere yönelik endovasküler girişimlerin kısa vadeli klinik başarı oranlarını ve komplikasyonlarını sunuyoruz. Ocak 2016 ile Aralık 2019 arasında AVF disfonksiyonu tanısı alan ve bu nedenle perkütan transluminal anjiyoplasti (PTA) uygulanan toplam 29 hemodiyaliz hastası bu çalışmaya dahil edildi. Tüm PTA'lar aynı deneyimli girişimsel kardiyolog tarafından yapıldı. Hastaların demografik, klinik verileri, birincil açıklık ve işlem komplikasyonlarına ilişkin veriler hastane veri tabanından ve/veya hastanın kendi hemodiyaliz merkezinin elektronik kayıtlarından elde edildi. İşlem sonrası “thrill”in saptanması, başarılı kanülasyon ve tedaviden hemen sonra yeterli hemodiyaliz yapılabilmesi klinik başarı olarak kabul edildi. Toplam 29 hemodiyaliz hastasına AVF disfonksiyonu nedeniyle PTA uygulandı. Hastaların ortanca yaşı 61 (IQR 55.0-68.0) olup, %72.4'ü erkekti. Hastaların %41'i diyabetikti. Ortanca AVF yaşı 44.0 (24.0-92.0) aydı. Jukstaanastomotik (%48.3) ve efferent ven darlığı (%37.9) AVF işlev bozukluğunun ana nedenleriydi. 27 hastaya paklitaksel salınımlı balon anjiyoplasti uygulandı. Girişimlerin klinik başarı oranı %93.1 idi. İki hastada femoral arter ponksiyon yerinde lokal hematom gelişmesi dışında diğer hastalarda başka bir majör veya minör komplikasyon gözlenmedi. Femoral arter yoluyla yapılan PTA girişimleri AVF disfonksiyonlarında etkili ve güvenli bir tedavi yöntemidir.

Rationale for minimally invasive surgery and its clinical use in early ANFH

Objectives. A study of the expedience of arthroscopic revision of hip cavity in conjunction with tunnelling, revision and sanitation of the femoral head necrosis site, followed by bone alloplasty early in disease, during surgical treatment of ANFH patients.Materials and methods. Minimally invasive two-stage decompression with bone alloplasty was performed as a surgical treatment in stage 0, 1, 2 ANFH patients at the orthopaedic unit of Vladimirtsev Territorial Clinical Hospital of Khabarovsk during 2017–2021. The survey included 60 patients examined as follows: clinical examination, radiography, multislice computed tomography and magnetic resonance imaging, with follow-ups in 6 and 12 months.Results and discussion. A detailed arthroscopy analysis was performed at different stages of the disease sequence, which allowed a comprehensive comparison of X-ray and intraarticular change data.Conclusions. The study demonstrated that therapeutic and diagnostic hip arthroscopy offers a number of clear advantages and allows decision on a surgical treatment tactics that minimises postoperative complications. The use of minimally invasive surgeries in early ANFH allows a stable regain of the patient social activity to postpone radical surgical interventions.

Comparison of bone mineral densityand biochemical factors in hemodialysis and peritoneal dialysis patients.

The aim of the study is to assess and compare the level of bone mineral density (BMD) in the patients undergoing hemodialysis (HD) and peritoneal dialysis (PD) and to identify risk factors related to low BMD. Dual-energy X-ray absorptiometry (DEXA) scans were performed in 34 HD patients and 47 PD patients. Serum levels of albumin, calcium, phosphorus, alkaline phosphatase (ALP), intact parathyroid hormone (I-PTH), and 25-hydroxy (OH) vitamin D were recorded for the prediction of BMD loss. Among the biochemical parameters compared, only calcium levels differed between the group in such that HD patients had lower calcium compared with patients on PD (p=0.001). The overall prevalence of osteoporosis (OP) among all participants was 27%. There was a negative correlation between femur neck BMD and age (r=-554, p=0.007), and BMI (r=-555, p=0.007). Diabetic nephropathy was the only etiology associated with decreased BMD at the femoral site (p=0.027). There was a positive correlation between the serum albumin and BMD of lumbar spine (LS) (r=585, p=0.004). Bone mass of any site did not correlate with the dialysis type, duration of dialysis, and other biochemical markers like serum calcium, phosphorus, I-PTH, ALP, and 25 (OH) vitamin D. Prevalence of OP and osteopenia are high in dialysis patients, with no difference between patients on regular HD and PD. Bone mass loss is related to older age, higher BMI, and lower serum albumin level. DEXA measurement is necessary to monitor bone loss and timely treatment of OP in dialysis patients.

Soft-tissue fixation is not inferior to suture-anchor fixation in reconstruction of the medial patellofemoral ligament using a nonresorbable suture tape.

Reconstruction of the medial patellofemoral ligament (MPFL-R) with nonresorbable suture tape (FiberTape®, FT) is becoming popular. Patella-side fixation of the FT can be performed with suture anchors or via soft-tissue fixation. The aim of this study was to investigate whether patella-side soft-tissue fixation can achieve equivalent primary stability compared to suture-anchor fixation. In ten human, fresh-frozen knee joint specimens (m/f 6/4; age 74 ± 9 a), the MPFL was identified and dissected near the femoral insertion site. In five knee joints, the MPFL-R using FT was performed with soft-tissue fixation at the patella (study group; SG), and in five knee joints, the FT was fixed via suture anchors (control group, CG). All reconstructions were evaluated until load to failure of the patella-side fixation with a displacement rate of 200mm/min. The mean maximum load to failure in the SG was 395.3 ± 57.9N. All reconstructions failed by complete tearing off the medial patellar retinaculum from its medial patellar margin, but fixation of the FT remained stable. In the CG, the mean maximum load to failure was 239.4 ± 54.5N and was significantly different compared to the SG (p = 0.04). All reconstructions failed via pullout of the suture anchors. Stiffness and elongation did not differ between the groups, and no failure of the FT was observed in any of the specimens. Primary stability of soft-tissue MPFL-R using FT was superior to suture-anchor fixation. Both fixation techniques provided sufficient primary stability, superior to previously reported native MPFL tensile strengths. MPFL-R with FT could be a possible alternative procedure for MPFL-R, eliminating potential complications due to autologous tendon graft harvesting.

Systemic effects of BMP2 treatment of fractures on non-injured skeletal sites during spaceflight.

Unloading associated with spaceflight results in bone loss and increased fracture risk. Bone morphogenetic protein 2 (BMP2) is known to enhance bone formation, in part, through molecular pathways associated with mechanical loading; however, the effects of BMP2 during spaceflight remain unclear. Here, we investigated the systemic effects of BMP2 on mice sustaining a femoral fracture followed by housing in spaceflight (International Space Station or ISS) or on Earth. We hypothesized that in spaceflight, the systemic effects of BMP2 on weight-bearing bones would be blunted compared to that observed on Earth. Nine-week-old male mice were divided into four groups: 1) Saline+Earth; 2) BMP+Earth; 3) Saline+ISS; and 4) BMP+ISS (n = 10 mice/group, but only n = 5 mice/group were reserved for micro-computed tomography analyses). All mice underwent femoral defect surgery and were followed for approximately 4 weeks. We found a significant reduction in trabecular separation within the lumbar vertebrae after administering BMP2 at the fracture site of mice housed on Earth. In contrast, BMP2 treatment led to a significant increase in trabecular separation concomitant with a reduction in trabecular number within spaceflown tibiae. Although these and other lines of evidence support our hypothesis, the small sample size associated with rodent spaceflight studies limits interpretations. That said, it appears that a locally applied single dose of BMP2 at the femoral fracture site can have a systemic impact on distant bones, affecting bone quantity in several skeletal sites. Moreover, our results suggest that BMP2 treatment works through a pathway involving mechanical loading in which the best outcomes during its treatment on Earth occurred in the weight-bearing bones and in spaceflight occurred in bones subjected to higher muscle contraction.

BIOMECHANICAL EVALUATION OF AN INVERTED FIXATION FOR ACL RECONSTRUCTION WITH NONMETALLIC HARDWARE AND TIBIAL SUBCORTICAL SUPPORT TO INCREASE STRENGTH AT THE TIBIAL SITE

In this paper, we evaluate the initial biomechanical properties of an anterior cruciate ligament (ACL) reconstruction technique that inverts the anatomical location of the commonly used hardware and relies the tibial fixation on the subcortical bone to increase tibial site strength. Four 7-specimen groups were tested in a porcine model: for the control ACL reconstruction technique, the femur with a cross-pin fixation supported in the trabecular bone and the tibia with a biodegradable interference screw (BIS); for the new proposed technique, the femur with a BIS and the tibia with a cross-pin fixation leaned on the tibial subcortical bone. The specimens were subjected to cyclic and load-to-failure tests to compute their biomechanical performance. At the tibia, the cross-pin fixation revealed higher resistance than the BIS ([Formula: see text] for ultimate load and [Formula: see text] = 0.006 for yield load), additionally cyclic and total displacement at representative loads showed extremely high values with BIS fixation (in two specimens greater than 9[Formula: see text]mm for 250 N and greater than 10[Formula: see text]mm for 450[Formula: see text]N). At the femur, no differences between fixations were observed. The inverted ACL reconstruction improves resistance at the tibial site with respect to the control technique, with similar resistance at the femoral site and no differences in total displacement at representative loads. It offers a useful and robust solution when greater tibial resistance is required.

Zirconia versus Titanium Implants: 8-Year Follow-Up in a Patient Cohort Contrasted with Histological Evidence from a Preclinical Animal Model.

Zirconia ceramic (ZC) implants are becoming more common, but comparisons between preclinical histology and long-term clinical trials are rare. This investigation comprised (1) 8-year clinical follow-up of one-piece ZC or titanium (Ti) implants supporting full overdentures and (2) histomorphometric analysis of the same implants in an animal model, comparing implants with various surface treatments. Methods: (1) Clinical trial: 24 completely edentulous participants (2 groups of N = 12) received 7 implants (one-piece ball-abutment ZC or Ti; maxilla N = 4, mandible N = 3) restored with implant overdentures. Outcomes after 8-years included survival, peri-implant bone levels, soft-tissue responses, and prosthodontic issues. (2) Preclinical trial: 10 New Zealand sheep received 4 implants bilaterally in the femoral condyle: Southern Implants ZC or Ti one-piece implants, identical to the clinical trial, and controls: Southern ITC® two-piece implants with the same surface or Nobel (NBC) anodised (TiUnite™) surface. %Bone-implant contact (%BIC) was measured after 12 weeks of unloaded healing. Results: 8 of 24 participants (33%) of an average age of 75 ± 8 years were recalled; 21% of original participants had died, and 46% could not be contacted. 80.4% of implants survived; excluding palatal sites, 87.5% of Ti and 79% of ZC implants survived. All failed implants were in the maxilla. Three ZC implants had fractured. Bone loss was similar for Ti vs. ZC; pocket depths (p = 0.04) and attachment levels (p = 0.02) were greater for Ti than ZC implants. (1.7 ± 1.6 mm vs. 1.6 ± 1.3 mm). All implants in sheep femurs survived. %BIC was not statistically different for one-piece blasted surface Ti (80 ± 19%) versus ZC (76 ± 20%) or ITC® (75 ± 16 mm); NBC had significantly higher %BIC than ITC (84 ± 17%, p = 0.4). Conclusion: Short-term preclinical results for ZC and Ti one-piece implants showed excellent bone-implant contact in unloaded femoral sites. This differed from the long-term clinical results in older-aged, edentulous participants. While ZC and Ti implants showed equivalent performance, the risks of peri-implantitis and implant loss in older, completely edentulous patients remain a significant factor.

ACL Graft Matching: Cadaveric Comparison of Microscopic Anatomy of Quadriceps and Patellar Tendon Grafts and the Femoral ACL Insertion Site

Background: The optimal graft choice between the bone–patellar tendon–bone (BPTB) and the quadriceps tendon remains controversial. Studies evaluating the microscopic anatomy of the quadriceps tendon–patellar bone (QTB) and BPTB grafts for anterior cruciate ligament (ACL) reconstruction are currently lacking. Hypothesis: The relationship between post–ACL reconstruction graft bending angle (GBA) and the angle corresponding to the GBA (cGBA) would indicate that the BPTB can bend more than the QTB at the femoral tunnel aperture. Study Design: Controlled laboratory study. Methods: Twenty paired human cadaveric knees fixed at <10° of knee joint flexion (mean age, 82.5 years) underwent histological sectioning and staining with Masson trichrome and toluidine blue. The femoral ACL insertion, QTB graft, and BPTB graft were microscopically analyzed. The width of the direct insertion, thickness of the uncalcified fibrocartilage and calcified fibrocartilage, ligament attachment angle, and cGBA for each group were measured. Eighteen patients who underwent ACL reconstruction with QTB or BPTB autograft were included for the evaluation of GBA using computed tomography images at 1 week postoperatively. Results: The mean insertion widths of the femoral ACL, QTB, and BPTB were 7.81, 9.07, and 6.54 mm, respectively. The QTB was 16% wider than the ACL, while the BPTB was 16% narrower than the ACL. The mean insertion thicknesses of the femoral ACL, QTB, and BPTB were 0.53, 0.94, and 0.38 mm, respectively. The QTB was 77% thicker than the ACL (P < .001), while the BPTB was 28% thinner than the ACL (P = .017). The mean ligament attachment angles of the femoral ACL, QTB, and BPTB were 20.3°, 30.2°, and 33.3°, respectively, and the QTB and the BPTB were 49% and 64% larger, respectively, than the ACL. The mean cGBAs of the femoral ACL, QTB, and BPTB were 33.9°, 35.1°, and 12.3°, respectively. The BPTB was 64% smaller than the ACL, while there was no significant difference between the QTB and the ACL. The mean GBA was 57.7°. Conclusion: The insertion width and thickness were significantly greater and smaller in the QTB and BPTB grafts, respectively, than in the ACL. The relationship between GBA after ACL reconstruction and cGBA in knee extension indicates that at the femoral tunnel aperture, the BPTB can bend more than the QTB. Clinical Relevance: QTB graft may allow more anatomic ACL reconstruction to be performed.

Early Ambulation of Patients with Post Transfemoral Arteriography with Vascular Closure Device (VCD): A Quality Improvement Project

<h3>Introduction</h3> Post Transfemoral Arteriogram (PTFA) is a minimally invasive diagnostic interventional procedure using venous closure device (VCD) to achieve hemostasis. Post procedure patient discomfort arises due to restrictions in position and prolonged bedrest. The postanesthesia care unit (PACU) nurses conducted an evidence-based practice (EBP) project that recommended early ambulation for PTFA with VCD between May 1, 2021 and December 1, 2021. <h3>Identification of the problem</h3> IR PACU patients' 120 minute supine positioning and 180 minute total bedrest time causes patient discomfort and PACU to go on hold – not allowing the operating room patients to be transferred. <h3>QI question/Purpose of the study</h3> Can supine positioning be reduced from 120 minutes to 60 minutes and total bedrest time be reduced from 180 minutes to 120 minutes without incidence of bleeding or trauma after PTFA with VCD? <h3>Methods</h3> This project compared current practice of IR patients that requires three-hour bedrest while maintaining supine head of bed (HOB) in flat position for two hours then elevating the HOB to 30 degrees for one additional hour vs implementing two-hour bedrest while maintaining supine HOB in flat position for one hour then elevating the HOB to 30 degrees for an additional hour. Data collection involved monitoring BP, HR, RR, femoral pulse check, femoral groin site check, pain score and patient satisfaction. <h3>Outcomes/Results</h3> Data showed reducing the total supination time from 120 minutes to to 69.95 minutes and total bedrest time from 180 minutes to to 108 minutes showed no increased risk for bleeding or trauma in the patient and overwhelmingly increased patient satisfaction related to decrease in back discomfort while supine and ability to void out-of-bed and/or without assistive devices. <h3>Discussion</h3> Cardiac Prep/PACU nurses recover interventional cardiac patients with the early ambulation protocol for one hour and progressively elevate HOB every thirty minutes. These patients safely ambulate after two hours. Further evaluation of this protocol could be cost effective due to decreased utilization of resources, manpower, and length of hospital stay. <h3>Conclusion</h3> PTFA with VCD patients can safely reduce their flat bedrest and ambulation time frames by one hour after PTFA with VCD. <h3>Implications for perianesthesia nurses and future research</h3> The science revealed ten years of research recommending safe ambulation within 120 minutes PTFA with VCD. Dissemination of these findings will advance the IR recovery process and improve patient satisfaction.

Comparison of Access Site Complications After Early or Late Sheath Removal in Patients with PCI, Regardless of ACT Levels.

Background: Despite the lack of supporting data, many clinics perform sheath removal 4-6 hours after femoral percutaneous coronary intervention to reduce the risk of possible access site complications. This study aims to examine the effects of sheath removal immediately after the procedure on access site complications and patient comfort.Methods:This prospective study included 349 patients who underwent percutaneous coronary intervention via the femoral site and 6 French guiding catheters. The sheath in the early group was removed immediately after the procedure without checking the activated clotting time levels but after 4 hours in the late group. Access site complications were recorded and patient comfort was evaluated using the Visual Analog Scale.Results:Patients were divided into 2 groups: patients in the early removal group (n = 171) and in the late removal group (n = 178). There was no statistically significant difference between the 2 groups in terms of access site complications. Three patients in the early removal group and 4 patients in the late removal group developed a hematoma. Six patients in the early removal group and 10 patients in the late removal group showed ecchymosis. The Visual Analog Scale score was statistically significantly lower in the early removal group compared with that in the late removal group [2 (1-3) vs. 3 (2-4), P < .001].Conclusion:This study shows that immediate sheath removal is safe and more comfortable for patients with percutaneous coronary intervention who received weight-adjusted dose of heparin, regardless of the percutaneous coronary intervention levels after the procedure.

Transradial Versus Transfemoral Approach for Endovascular Thrombectomy of Left Anterior Circulation Stroke With Bovine Arch

Transradial Versus Transfemoral Approach for Endovascular Thrombectomy of Left Anterior Circulation Stroke With Bovine Arch

Paper 84: Differences in Metrics of Knee Joint Loading Between Individuals Following a Primary Anterior Cruciate Ligament Repair (ACL-R) Surgery Versus Those Who Underwent a Standard ACL Reconstruction with a Patella Bone-Tendon-Bone Autograft (ACLR)

Objectives:Recent research suggests that the short- and long-term outcomes following Anterior Cruciate Ligament Reconstructions (ACLR) on knee joint health are worse than originally thought. The ACLR procedure may result in or expediate the arthritic process through a variety of factors including prolonged underloading of the knee joint following surgery. These recent findings have resulted in a renewed interest in the ACL repair (ACL-r) procedure as a potentially more joint “friendly” secondary to less surgical trauma with the preservation of the native ACL ligament. In several animal models and in human clinical data, ACL remnant preservation and ACL entire ligament repair/preservation has been shown to benefit lower extremity and knee biomechanics, proprioception, and short term clinical outcomes. However, there is limited data on the newer ACL-r techniques and their subsequent outcomes on knee joint loading. Therefore, the purpose of this study was to assess for differences in metrics of knee joint loading between individuals following a primary anterior cruciate ligament repair (ACL-r) surgery versus those who underwent a standard ACL reconstruction with a patella bone-tendon-bone autograft (ACLR).Methods:A total of 30 participants were enrolled into this study [ACL-r n: 15, age(yrs): 38.8±13.9, Ht(cm): 173.4±10.0, Wt(kg): 77.9±17.5; ACLR: n: 15, age(yrs): 25.60±1.7, Ht(cm): 173.5±10.3, Wt(kg): 75.4±15.6]. Participants in ACL-r group all sustained a proximal ACL disruption (Sherman Classification Type 1 or 2) that was amenable to repair and underwent primary ACL repair with suture fixation. ACL-r was performed under arthroscopic visualization with 2 or 3 standard portals in a technique similar to that described by van der list, MD (2017), but modified by the senior author to include only one 4.75mm swivelock (Arthrex) secured in the anterior aspect of the native footprint on the medial wall of the lateral femoral condyle. Participants in the ACLR group all underwent a primary ACLR with patella bone-tendon-bone autograft. The autograft bone blocks were crimped to 9mm and then two 10mm femoral and tibial tunnels created for the graft. An independent tunnel technique, utilizing the medial portal for creation of the femoral socket within the native ACL femoral attachment site, was performed in all ACLR patients. At 12 weeks following surgery participants in both groups completed the IKDC questionnaire and biomechanical testing with two AMTI force plates and a 10 camera Qualisys motion capture system. Peak knee extension moment (Nm/Ht*Wt) and total knee joint power (Watt/Ht*Wt) as a measure of eccentric loading (contraction) during the descent phase of a single-leg squat were calculated on the surgical limb and averaged across the middle three trials. Participants also completed quadriceps strength testing on both limbs (surgical and non-surgical) on an isokinetic dynamometer at 60 °/sec. The average peak torque of five repetitions were used to calculate a limb symmetry index (LSI) [Surgical/NonSurgical X100]. Independent t-tests were used to assess for differences between groups in three metrics. For descriptive purposes a separate independent t-test was used to assess for differences in age, height, mass, and IKDC scores. Statistical significance was set at P< 0.05 for all analyses.Results:There were no differences in height (p=0.996), mass(p=.678), or IKDC ( p=0.886) scores between the groups; however, there was a significant difference in age (p=0.009). The ACL-r had a significantly greater peak knee extension moment (ACL-r: -0.078±0.02; ACLR: -0.059±.02; p=0.014) and total knee joint power (ACL-r-0.03±0.01; ACLR: -0.02±0.01, p=0.016) than the ACLR group. The ACL-r also had a significantly great quadriceps LSI than the ACLR group (ACL-r: 65.09±20.4, ACLR: 49.2±11.4, p=0.014).Conclusions:The results of this study indicate that those individuals following ACL-r demonstrate increased knee joint loading during a single leg squat task compared to those who underwent ACLR. Decreases in knee extension moment have been reported across a variety of tasks and across a variety of time points following ACLR. Furthermore, decreased knee extension moments have been associated with movement profiles that have been linked to cartilage degeneration following ACLR. The improved knee extension moment in the ACL-r group at this early time may indicate a positive change in joint loading and potentially a decreased rate of cartilage degeneration. Knee joint total power accounts for both knee moment and angular velocity, indicating improved knee loading throughout the entire eccentric movement in the ACL-r group and further supports the notion of improved knee joint loading following ACL-r compared to ACLR. Decreased quadriceps muscle strength has been associated with changes in cartilage structure and it has been suggested that maximizing muscle strength in the first 6 months following surgery may promote improved cartilage healing, thus the increased quadriceps LSI in the ACL-r may be protective early in the recovery process.

Efficacy and safety of the biosimilar denosumab candidate (Arylia) compared to the reference product (Prolia®) in postmenopausal osteoporosis: a phase III, randomized, two-armed, double-blind, parallel, active-controlled, and noninferiority clinical trial

Background/objectiveOsteoporosis is a global health concern with an increasing prevalence worldwide. Denosumab is an antiresoptive agent that has been demonstrated to be effective and safe in osteoporotic patients. This study aimed to compare the efficacy and safety of the biosimilar denosumab candidate (Arylia) to the originator product (Prolia®) in postmenopausal osteoporotic patients.MethodsIn this randomized, double-blind, active-controlled, noninferiority trial, postmenopausal osteoporotic patients received 60 mg of subcutaneous Arylia or Prolia® at months 0, 6, and 12 and were followed up for 18 months. The primary endpoint was the noninferiority of the biosimilar product to the reference product in the percentage change of bone mineral density (BMD) in 18 months at the lumbar spine (L1-L4), total hip, and femoral neck. The secondary endpoints were safety assessment, the incidence of new vertebral fractures, and the trend of bone turnover markers (BTMs).ResultsA total of 190 patients were randomized to receive either biosimilar (n = 95) or reference (n = 95) denosumab. In the per-protocol (PP) analysis, the lower limits of the 95% two-sided confidence intervals of the difference between Arylia and Prolia® in increasing BMD were greater than the predetermined noninferiority margin of − 1.78 at the lumbar spine, total hip, and femoral neck sites (mean differences [95% CIs] of 0.39 [− 1.34 to 2.11], 0.04 [− 1.61 to 1.69], and 0.41 [− 1.58 to 2.40], respectively). The two products were also comparable in terms of safety, new vertebral fractures, and trend of BTMs.ConclusionThe efficacy of the biosimilar denosumab was shown to be noninferior to that of the reference denosumab, with a comparable safety profile at 18 months.Trial registrationClinicalTrials.gov, NCT03293108; Registration date: 2017–09-19.

OUTCOME-BASED THRESHOLD FOR CAROTID-FEMORAL PULSE WAVE VELOCITY: THE IDCARS STUDY

Objective: Guidelines recommend a &gt; 10m/s threshold of carotid-femoral pulse wave velocity (cf-PWV) to detect hypertension mediated organ damage. However, the &gt; 10m/s threshold was derived from the cf-PWV distribution across cross-sectional studies with limited contribution of prospective cohort studies. Using data from the International Database of Central Arterial Properties for Risk Stratification (IDCARS), we aimed to determine an outcome-based threshold for cf-PWV. Design and method: Adults (&gt; = 18 years) recruited by eight IDCARS centres and followed up for 6 months or longer qualified for inclusion in the current subject-level meta-analysis. Cf PWV was measured using the Sphygmocor device (Itasca, IL). Pulse transit distance was determined by subtracting the distance between the carotid sampling site and the suprasternal notch from the distance between the carotid and femoral sample sites. The primary endpoint consisted of fatal and nonfatal cardiovascular events. Total and cardiovascular mortality and fatal and nonfatal coronary events were secondary endpoints. The cf-PWV threshold was determined by multivariable Cox regression with average risk based on established risk factors in the whole cohort as reference. Results: After 5.0 years of follow-up (median), of 3494 participants (mean age: 52.2 years; women: 55.3%; mean cf-PWV: 7.8 m/s), 156 (4.5%) experienced the primary endpoint, and 104 (3.0%) died, 25 (0.7%) of cardiovascular disease and 77 (2.2%) had a coronary event. After whole adjusting for sex, age, systolic blood pressure, heart rate and other cardiovascular risk factors, the outcome-driven cf-PWV thresholds were 8.6, 9.1, 8.7 and 8.6 m/s for a composite cardiovascular endpoint, all-cause and cardiovascular mortality and a coronary event, respectively. A cf-PWV &gt; = 9 m/s (n = 752, 21.5%), compared with slower velocities, had an increased risk of a composite cardiovascular endpoint (HR: 1.75; 95% CI: 1.20–2.54, P = 0.004). Conclusions: The outcome-based threshold of &gt; = 9 m/s for cf-PWV, which was present in 20% of the IDCARS participants, is close to the cut-off limit proposed by guidelines based on other approaches.

Effectiveness of Standardized Nursing Care Protocol Post Cardiac Catheterization to Reduce Hematoma Development

Background: Hematoma development is the most common vascular access complication among post-cardiac catheterization patients. It requires safe and standardized nursing care protocol, as well as qualified and skilled health providers to obtain good outcomes of management. The vascular complications were severe and increased the length of stay in the hospital. Timely recognition and management can diminish their burden.&#x0D; Objectives&#x0D; &#x0D; To evaluate the effectiveness of Standardized Nursing Care Protocol Post cardiac catheterization to reduce hematoma development.&#x0D; To assess the association of hematoma development between procedure site (radial and femoral) and comorbidities (diabetes, hypertension, and obesity) among post-cardiac catheterized patients.&#x0D; &#x0D; Methodology: This quasi-experimental (post) study was conducted at Coronary Care Units at tertiary care hospitals in Karachi. In this study, a total of 108 post-cardiac catheterized patients participated. The patients were divided into two groups; the interventional group and the control group. In the control group, 54 post-cardiac catheterized patients were selected and data were taken based on inclusion criteria who received routine holistic nursing care post-procedure and have been discharged. Besides 54 patients participated in the interventional group who received Standardized Nursing Care Protocol post-cardiac catheterization including proper patient assessment, compression techniques, interventions pre, during and post sheath and TR-band removal to discharge instruction by the principal investigator (PI). The data was collected through patients’ assessment sheets and hematoma scales for the identification of hematoma development rate among post-cardiac catheterized patients. The non-probability consecutive sampling technique was accomplished for the collection of data.&#x0D; Findings: The rate of hematoma development in the (control) group was reflected at 18 (33.3 %) while after the implementation of the standardized nursing care protocol the rate of hematoma development was 9 (16.6%) in the (interventional) group out of 54 (50%) post-cardiac catheterized patients. There was a significant difference between the (control) and (interventional) groups regarding the rates of hematoma development post-cardiac catheterization i.e. the P values were 0.037 ˂ 0.05. Thus, the standardized nursing care protocol post-cardiac catheterization was effective in the reduction of hematoma development. Furthermore, the radial site procedure reflected fewer rates of hematoma development 8 (14.81%) as compared to the femoral site procedure 19 (35.1%) among post-cardiac catheterized out of 54 (50%). The P-value was 0.058 &gt; 0.05 there was no association between hematoma development and procedure site in the (interventional and control) groups post-cardiac catheterization. Similarly, the P-value was greater than 0.05 hence there was no association between hematoma development and comorbidities (diabetes, hypertension, and obesity) post-cardiac catheterization.&#x0D; Conclusion: The implementation of Standardized Nursing Care Protocol post-cardiac catheterization was effective for the reduction of hematoma development in the (intervention) group while there was an association of hematoma development between the (control and interventional) groups. However, there was no association between hematoma development and site procedure (radial and femoral) and comorbidities (diabetes, hypertension, and obesity) post-cardiac catheterization.

Extravascular Access Artery Closure After Percutaneous Peripheral Intervention

Percutaneous closure of the access artery has become commonplace after endovascular intervention. In patients with peripheral vascular occlusive disease, however, control of the puncture site is more problematic as the access artery is frequently plaque-laden and stenotic. Ischemic complications in the access extremity are more common in these cases, particularly when using devices that depend on the deployment of prosthetic material within the compromised arterial lumen. The purpose of this retrospective clinical study was to assess the efficacy of totally extravascular/bioresorbable closure of the femoral artery puncture sites after percutaneous peripheral intervention (PPI).

Leadless cardiac pacemaker in elderly patients: How old for a new technology?

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Leadless transcatheter pacemakers are considered as a safe and effective option for cardiac pacing in patients (pts) at higher risk of complications with conventional transvenous cardiac pacing. Purpose Our aim was to assess the clinical "real-life" feasibility and outcomes of leadless pacing in elderly pts in a high-volume center over a mid-term follow-up (FU) period. Methods Elderly pts (aged ≥ 75 years) who underwent leadless MICRA® system pacemaker implantation with a FU period above 3 months were included in this retrospective monocentric study. Results 130 pts were included (84 ± 5.6 years old, male 66.2%). Indications were: Atrioventricular block (permanent 15.4%; transient 27.7%), atrial fibrillation bradycardia 50% and sinus node dysfunction 6.9%. Leadless system pacing was preferred over conventional pacing in pts with: transvenous pacemaker extractions due to infectious 18.5% or vascular 1.5% complications; active systemic infection and urgent need for cardiac stimulation 20%; complex conventional vascular approach 21.6%; severe tricuspid valve disease 1.5%; deterioration of general condition and clinical frailty 22.3%; shortly after transvalvular aortic valve replacement 8.5%. Among the pts, 6.2% had previous leadless Nanostim® device implantation with dysfunction of the system. Pts had either local anesthesia 13.2% or deep sedation 86.8%. The average fluoroscopy time was 4.3±2.9 minutes and number of device deployments before the final position ranged from 1 to 7 with a mean value of 1.5±1 positions. Pacing threshold during implant was 0.5±0.4 V at 0.24ms, only 4 pts (3%) had an implant threshold of &amp;gt;1.0 V at 0.24 ms. Two postoperative deaths were observed: 1 cardiac arrest related to myocardial dysfunction and consequent pulmonary edema in a patient with advanced heart failure, and 1 death secondary to myocardial perforation with need for surgical repair that occurred among the first implantations with an apical device position and a patient with multiple comorbidities. The total rate of major complications was 2.3% with only 1 vascular complication at the femoral puncture site. The median time from the leadless pacemaker implant procedure to discharge was 5±6.5 days (minimum 1 and maximum 40 days): 55.6% pts were able to leave the cardiology department within the first 72 hours. The mean FU period was 17 months ± 15 months with a mortality rate of 12.3% (cardiovascular impairment 5.4%; non cardiovascular-related deaths 6.9%). Increase in pacing thresholds was noted in 4 pts with subsequent stabilization; 92.2% of pts presented with thresholds lower than 1V at 0.24 ms. All pts remained free of infections during FU with no cases of device dislodgement observed. Conclusion Elderly pts are at higher risk of complications; our experience confirms their clinical frailty and underlines the favorable safety profile of leadless system pacing with a low rate of complications and stable pacing thresholds.