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PURPOSE: To describe our experience over 6 years using a new high-density polyethylene-based spherical integrated porous orbital implants (Oculfit). METHODS: This is an observational retrospective case series study analyzing all cases requiring Oculfit implants between February 2015 and September 2021. Clinical information regarding the population included, the characteristics of the implant, and the outcomes and complications during the follow-up were noted. The success of the implant was defined according to anatomical and functional parameters. RESULTS: The study analyzed 90 cases of anophthalmic patients. The main causes for enucleation or evisceration were ocular decompensations (36.7%) and neoplasms (27.8% uveal melanoma and 7.8% retinoblastoma). Anatomical success was identified in 63 (70.0%) cases, functional success in 79 (87.8%) and complete success (anatomical + functional) in 61 (67.7%) cases. Factors associated with the functional success were age and exposure of the primary orbital implant. Complications appeared in 11 (12.2%) cases, which were completely resolved without sequelae in 4 (4.4%). Orbital explant was required in 5 (5.6%) cases. CONCLUSION: In our experience, Oculfit can be considered a useful alternative among the currently available options for orbital implants and has a good efficacy/safety profile.

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BACKGROUND: Commercially available osseointegrated devices for transfemoral amputees are limited in size and thus fail to meet the significant anatomical variability in the femoral medullary canal. This study aimed to develop a customized osseointegrated stem to better accommodate a variety of femoral anatomies in transfemoral amputees than off-the-shelf stems. Customization is expected to enhance cortical bone preservation and increase the stem-bone contact area, which are critical for the long-term stability and success of implants. METHODS: A customized stem (OsteoCustom) was designed based on the statistical shape variability of the medullary canal. The implantability of the OsteoCustom stem was tested via 70 computed tomography (CT) images of human femurs and compared to that of a commercial device (OFI-C) for two different resection levels. The evaluations included the volume of cortical bone removed and the percentage of stem-bone contact area for both resection levels. Statistical significance was analyzed using paired and unpaired t tests. RESULTS: The OsteoCustom stem could be virtually implanted in all 70 femurs, while the OFI-C was unsuitable in 19 cases due to insufficient cortical thickness after implantation, further emphasizing its adaptability to varying anatomical conditions. The OsteoCustom stem preserved a greater volume of cortical bone than did the OFI-C. In fact, 42% less bone was removed at the proximal resection level (3.15 cm³ vs. 5.42 cm³, p ≤ 0.0001), and 33% less at the distal resection level (2.25 cm³ vs. 3.39 cm³, p = 0.003). The stem-bone contact area was also greater for the OsteoCustom stem, particularly at the distal resection level, showing a 20% increase in contact area (52.3% vs. 32.2%, p = 0.002) compared to that of the OFI-C. CONCLUSIONS: The OsteoCustom stem performed better than the commercial stem by preserving more cortical bone and achieving a greater stem-bone contact area, especially at distal resection levels where the shape of the medullary canal exhibits more inter-subject variability. Optimal fit in the distal region is of paramount importance for ensuring the stability of osseointegrated implants. This study highlights the potential benefits of customized osseointegrated stems in accommodating a broader range of femoral anatomies, with enhanced fit in the medullary canal.

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Purpose: To investigate the real-world efficacy of a novel, low-cost glaucoma drainage device in canine and human patients. Methods: A retrospective case series of 17 eyes in 14 canines and one eye of a human patient who each underwent novel drainage device implantation is described. This device was constructed by insertion and advancement of a 24-gauge cannula (canine) or 23-gauge cannula (human) perpendicularly through five adjacent tubes of a 25-mm Yeates surgical drain. Results: Of the canine patients, the average follow-up period was 362 days (range, 27-863). The mean preoperative intraocular pressure (IOP) was 50.9 ± 17.9 mm Hg. Following tube surgery, IOP was maintained at <20 mm Hg in 81.3%, 100%, 100%, 85.7%, 100%, and 75.0% of eyes at 1, 2, 3, 6, 9, and 12 months, respectively. Bleb needling and/or revisions were required in five eyes. Enucleations and/or device explantations were performed in five eyes at mean day 140. In the human case, the device was implanted in the right eye of a 64-year-old male with refractory raised IOP (55 mm Hg) despite maximum medical therapy. IOP was well controlled until day 818, when eventual tissue breakdown necessitated device removal. Conclusions: This design represents a novel, low-cost, effective alternative to traditional glaucoma tube devices. Translational Relevance: This device has great potential for use in regions where the needs for glaucoma drainage devices and surgical alternatives to trabeculectomy have not been met. Further development may include tube crimping or fenestration and preoperative loading of slow-release antibiotics and/or anti-metabolite medications within the non-draining lumens.

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En bloc resection is required for treatment of intermediate-grade talar tumors with extraosseous extension (Enneking stage 3) and malignant talar tumors without intra-articular invasion (Enneking stages IA and IIA). After resection, reconstruction options include tibiocalcaneal fusion, frozen autograft, and talar prosthesis; however, a talar prosthesis is preferable because it preserves ankle range of motion, does not cause leg length discrepancy, and is associated with good long-term outcomes. To the best of our knowledge, en bloc resection and reconstruction of a malignant talar tumor has not been previously reported in detail. We report a detailed surgical technique for en bloc resection of a malignant talar bone tumor using combined anterior and lateral approaches followed by reconstruction using a talar prosthesis.

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This case series reports eight eyes with keratoconus treated with laser implantation of one or two segments of progressive thickness corneal intrastromal ring (PT-ICRS). In this case series, it was evident that the insertion of PT-ICRS induces more pronounced corneal flattening at the thickest point, causing a reduction in distortion (coma) and lower astigmatism, resulting in a remarkable improvement in vision. Compared to the implementation of traditional intrastromal rings, the PT-ICRS variant showed superior results despite the small sample size. However, the same degree of asymmetry enhancement was not observed in cases in which a 330° PT-ICRS was implanted, despite the improvement in visual results when replacing a 320° traditional ring with a 330° PT-ICRS. These conclusions are limited as this is a case series with few cases.

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OBJECTIVE: To investigate the clinical outcomes of bone-anchored hearing implant surgery using the MONO procedure. STUDY DESIGN: Multicenter, multinational, single-arm, prospective trial with a 12-month follow-up. SETTING: Seven European university hospitals from the United Kingdom, Sweden, Denmark, and The Netherlands. PATIENTS: Fifty-one adult patients requiring surgical intervention for bone conduction hearing. INTERVENTION: Bone-anchored hearing implant surgery using the MONO procedure. MAIN OUTCOME MEASURES: The primary endpoint assessed implant usability 3 months after surgery. Implant status, soft tissue reactions, pain and numbness, postoperative events, and sound processor usage were assessed at all follow-up visits. Hearing-related quality of life was evaluated using the Glasgow Benefit Inventory (GBI). RESULTS: At 3 months, 94.2% of the implant/abutment complexes provided reliable anchorage for sound processor usage. No severe intraoperative complications occurred. Sixty-nine percent of surgeries were performed under local anesthesia, with surgery lasting 10 minutes on average. Four implants were lost due to trauma (n = 2), spontaneous loss of osseointegration (n = 1), or incomplete insertion (n = 1). Adverse soft tissue reactions occurred in 2.6% of visits, with a maximum Holgers grade of 3 (n = 1) and grade 2 (n = 5) across patients. Hearing-related quality of life at 3 months improved in 96% of patients. CONCLUSION: The MONO procedure provides a safe and efficient surgical technique for inserting bone-anchored hearing implants with few and minor intra- and postoperative complications.

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As an alternative to transvenous ICD systems, two non-transvenous ICD systems have been established in recent years: The subcutaneous ICD (S-ICD), which has been established for several years, has a presternal electrode that is implanted subcutaneously and offers a shock function and, to a limited extent, post-shock pacing. In addition, the extravascular ICD (EV-ICD) has been available in Europe since 2023 which does not require transvenous electrodes and offers the option of providing patients with antibradycardic and antitachycardic stimulation in combination with a conventional ICD function. The lead of this device is implanted substernally. Initial implantation results are promising in terms of safety and effectiveness. Both systems avoid possible complications of transvenous electrodes. This article provides practical guidance for the implantation technique and possible complications.

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The treatment of male severe stress incontinence (MUI) after surgery is the implantation of an artificial urinary sphincter (AUS). Traditionally you need two incisions: perineal and inguinal. Our objetive is present a series of patients treated with the Zephyr 375 EUA implant through a single perineal incision. We present six men operated on for MUI after Transuretral resection of the prostate (TURP) (1) and radical prostatectomy (5). Preoperatively we perform Pad-Test and cystoscopy. Under epidural anesthesia, a vertical perineal incision was made and dissection up to the bulbospongiosus muscle was divided and we dissected the bulbar urethra. After removing the probe, we place the cuff, checking that it reaches the appropriate pressure, leaving it deactivated. To place the pump-reservoir, we digitally develop a scrotal dartos pocket from the perineum that we close with Vicryl 3/0. After closing the muscle with 3/0 Vicryl, we left a suction drain and a bladder catheter. The mean age was 63 years (55-72). Mean surgical time was 68 minutes (60-85). All were discharged the next day without catheter and drain. All patients comfortably palpated the scrotal reservoir-pump. After activation, all patients were continent without needing additional adjustment, using 3 a safety pad. The degree of satisfaction was very high, all of them affirmed that they would undergo the same intervention again. The Zephyr 375 urinary sphincter allows placement through a single perineal incision, reducing surgical time, simplifying the technique, and reducing morbidity without compromising the functional outcome.

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PURPOSE: To assess the efficacy of a gelatin stent (XEN 45 Gel Stent; Allergan) implant in advanced glaucoma eyes that have failed prior aqueous shunt implantation. METHODS: We retrospectively reviewed 6 patients with refractory glaucoma, defined as persistently high IOP (> 21 mmHg) despite taking at least 3 IOP-lowering medications subsequent to undergoing a glaucoma drainage device (GDD) with or without a second GDD or cilioablative procedure. Eyes with previous failed GDD underwent subconjunctival 0.3 cc (0.4 mg/ml) mitomycin C, tenonectomy, and placement of an ab- externo XEN stent. The outcome measures included change in IOP and the number of glaucoma medications. Success was defined as patients achieving an IOP ≤ 18 mmHg with a percentage reduction of 25% or 15 mmHg and 40% mean IOP reduction from baseline while taking the same number or fewer medications. RESULTS: All six eyes with age of 77.6 ± 7.82 years who underwent XEN implantation following previous GDD surgery had primary open-angle glaucoma. The IOP decreased significantly from 32.33 ± 5.99 to 12.67 ± 3.27 mmHg (p < 0.001) with a follow-up of 13.9 ± 2 (11.7-16.7) months. Visual acuity and visual field remained stable after XEN placement. Compared to the baseline number of medications of 4.2 ± 0.8, all medication was discontinued except in one eye on two drops at the end of the follow-up. The overall surgical success rate was 100%. No complications, needling, or additional procedures were required. CONCLUSION: This study described successful implantation of the XEN stent following failed GDD. XEN Gel stent implantation associated with mitomycin C and tenonectomy can be considered a viable surgical option for patients with a history of previously failed tube shunt requiring further IOP lowering.

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Aims: Endoprosthetic reconstruction following distal femur tumour resection has been widely advocated. In this paper, we present the design of an uncemented endoprosthesis system featuring a short, curved stem, with the goal of enhancing long-term survivorship and functional outcomes. Methods: This study involved patients who underwent implantation of an uncemented distal femoral endoprosthesis with a short and curved stem between 2014 and 2019. Functional outcomes were assessed using the 1993 version of the Musculoskeletal Tumour Society (MSTS-93) score. Additionally, we quantified five types of complications and assessed osseointegration radiologically. The survivorship of the endoprosthesis was evaluated according to two endpoints. A total of 134 patients with a median age of 26 years (IQR 16 to 41) were included in our study. The median follow-up time was 61 months (IQR 56 to 76), and the median functional MSTS-93 was 83% (IQR 73 to 91) postoperatively. Results: Overall, 21 patients (16%) encountered complications, and the rate of aseptic loosening was 7% (9/134). The survival rate up to 8.5 years was 93% for aseptic loosening as the endpoint, and 88% for any reason as the endpoint, retrospectively. Conclusion: The use of an uncemented distal femoral endoprosthesis with a short, curved stem demonstrated a low incidence of aseptic loosening and achieved long-term survivorship of up to nine years. Meanwhile, aseptic loosening typically occurs in the early stage postoperatively.

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PURPOSE: The study investigated the effect of capsular tension ring (CTR) implantation on postoperative refractive stability and accuracy of intraocular lens (IOL) formulas for axial length (AL) ≥ 27.0 mm patients. METHODS: Prospective case series. The eyes of patients underwent phacoemulsification extraction combined with IOL implantation were classified as CTR implantation (A-CTR) and without CTR implantation (B-CON) groups. Refractive outcome and anterior chamber depth (ACD) were recorded at 1 week, 1 month, and 3 months post-operation. Prediction refractive error (PE) and absolute refractive error (AE) of each formula were calculated. RESULTS: A total of 89 eyes (63 patients) were included and randomized into the CTR (A-CTR) and control groups (B-CON). Comparison of refraction at different postoperative times of the CTR group showed no statistical difference (all P > 0.05). The ACD in the A-CTR group gradually deepened, and that in the B-CON group gradually shallowed (all P > 0.05). The formulas' AE showed statistically significant differences in CTR and CON groups (P < 0.001). The PE of Hill-RBF 2.0 and EVO formulas in the A-CTR group were more hyperopic than that in the B-CON group (all P > 0.05), the other five formulas were more myopic in A-CTR group than that in the B-CON group (all P > 0.05). CONCLUSION: Patients with 13 mm diameter CTR implantation tended to have stable refraction at 1 week post-surgery and 1 month for those without it. CTR of the 13 mm diameter had no effect on the selection of formulas. Additionally, it is found that Kane and EVO formulas were more accurate for patients with AL ≥ 27.0 mm.

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Fusion imaging (FI) technology using EchoNavigator that integrates live transesophageal echocardiogram and overlays on real-time fluoroscopy. We present our experience placing a right ventricular (RV) support device, a ProtekDuo, in our patient with post-operative RV failure using FI to guide the implantation.

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PURPOSE: To determine the clinical outcomes in patients after type 1 Boston keratoprosthesis surgery and the significance of ultrasound biomicroscopy imaging for postoperative follow-up. METHODS: This retrospective analysis included 20 eyes of 19 patients who underwent corneal transplantation with type 1 Boston keratoprosthesis between April 2014 and December 2021. Data on patient demographics, preoperative diagnosis, visual acuity, and postoperative clinical findings were analyzed. RESULTS: Type 1 Boston keratoprosthesis implantation resulted in intermediate- and long-term positive outcomes. However, blindness and other serious complications such as glaucoma, retroprosthetic membrane formation, endophthalmitis, or retinal detachment also occurred. The use of ultrasound biomicroscopy imaging allowed for better evaluation of the back of the titanium plate, anterior segment structures, and the relationship of the prosthesis with surrounding tissues, which provided valuable postoperative information. CONCLUSION: Regular lifetime monitoring and treatment are necessary in patients who undergo Boston type 1 keratoprosthesis implantation for high-risk corneal transplantation. ultrasound biomicroscopy imaging can be a valuable imaging technique for the evaluation of patients with Boston type 1 keratoprosthesis, providing important information on anterior segment anatomy and potential complications. Further studies and consensus on postoperative follow-up protocols are required to optimize the management of patients with Boston type 1 keratoprosthesis.

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INTRODUCTION: This study reviews the feasibility of implanting active osseointegrated bone conduction devices in young children, below the prior age for FDA indication (<12 years), which has recently been reduced to 5 years. Outcomes included differences in adverse event rates and operative time between two groups (<12 and 12 years or older). MATERIALS AND METHODS: This study is a retrospective review of children receiving active osseointegrated bone conduction devices at a tertiary referral center academic hospital. One hundred and twenty-four children received 135 active osseointegrated bone conduction devices (May 2018-March 2024). RESULTS: Of 135 devices, 77 (57%) were in children <12 years (mean age (SD) = 7.9 (2.0) years, range = 4.9-11.9 years) and 58 (43%) were in 12 years or older (mean age (SD) = 15.1 (1.7) years, range = 12-18 years). Adverse events were significantly higher in the older group, occurring in 8 (10%) of 77 devices in children <12 years and 15 (26%) of 58 devices in children 12 years and older (26%) (Fisher's exact test = 0.0217 at p < 0.05). Major adverse events occurred in 5/124 (4%) patients, with 2 in patients <12 years (2/73, 3%) and 3 in children 12 and older (3/51, 6%). The proportion of major events between groups was not significantly different (Fisher's exact test = 0.4, p < 0.05). Mean surgical time was significantly less (t = -2.8799, df = 120.26, p = 0.005) in the children <12 years (mean (SD) = 66.5 (22.4) min) compared to those 12 and over (mean (SD) = 78.32 (23.1) min). CONCLUSIONS: Implantation of active osseointegrated bone conduction devices is feasible in children as young as 5 years and demonstrates low rates of complication. Further miniaturization may allow even earlier safe intervention.

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PURPOSE: To compare the lifespan of first transcorporal cuff (TC) placement of an artificial urinary sphincter (AUS) versus standard placement (SP) in patients with prior radiotherapy (RT) for prostate cancer (PCa). METHODS: We reviewed first (virgin) AUS placements from two high-volume care centers between 1/2011 and 1/2021, including PCa patients with RT history. AUS lifespan was assessed via the hazard ratio of device explantation and/or revision within a ten-year timeframe for the TC vs. SP approaches. Chi-square, Fisher's exact, and t-tests compared clinicodemographic variables. Kaplan-Meier curve compared TC and SP lifespan. RESULTS: 85/314 men with AUS met inclusion criteria, with 38.8% (33/85) in the TC group and 61.2% (52/85) in the SP group. Median ages were 69.8 (IQR = 65.2-73.6) and 67.1 (61.6-72.9), respectively, p = 0.17. Over a median follow up of 51.9 (15.8-86.1) and 80.4 (28.1-128.3) months for the TC and SP, overall, 12 (36.4%) TC devices were removed (four [12.1%] due to mechanical failures; eight [24.2%] erosions, and two [6.1%] infections) vs. 29 (55.8%) in the SP group (14 [26.9%] mechanical failures; 11 [21.1%] erosions, and five [9.6%] infections). No statistically significant differences were observed between the two approaches, with HR = 0.717, 95% CI 0.37-1.44, p = 0.35. The calculated device survival probabilities for the TC vs. SP at one, five, and 10 years were 78.8% vs. 76.9%, 69.3% vs. 58.7%, and 62.1% vs. 46.7%, respectively. CONCLUSIONS: TC cuff insertion for the first AUS implantation in pre-radiated patients showed to be comparable to SP when it comes to device survival, with comparable complication rates. Current guidance for approach selection is primarily based on patient selection and surgeon preference.

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AIMS: Leadless pacemaker therapy was introduced to overcome lead- and pocket-related complications in conventional transvenous pacemaker systems. Implantation via the femoral vein, however, may not always be feasible. The aim of this study was to evaluate leadless pacemaker implantation using a jugular vein approach and compare it to the standard implantation via the femoral vein. METHODS AND RESULTS: The records of the first consecutive 100 patients undergoing Micra™ leadless pacemaker implantation via the right internal jugular vein from two centres were included in this study. Peri-procedural safety and efficacy of the jugular approach were compared to the first 100 patients using a femoral implantation approach at the University Hospital Zurich. One hundred patients underwent successful implantation of a leadless pacemaker via the internal jugular vein (mean age, 81.18 ± 8.29, 60% males). Mean procedure time was 35.63 ± 10.29 min with a mean fluoroscopy time of 4.66 ± 5.16 min. The device was positioned at the inferior septum in 25 patients, at the high septum in 24 patients, and mid-septum in 51 patients. The mean pacing threshold was 0.56 ± 0.35 V at 0.24 ms pulse width with a sensed amplitude of 10.0 ± 4.4 mV. At follow-up, electrical parameters remained stable in all patients. Compared with femoral implantation, patients undergoing the jugular approach were of similar age and had similar comorbidities. Mean procedure (48.9 ± 21.0 min) and fluoroscopy times (7.7 ± 7.8 min, both P < 0.01) were shorter compared to the femoral approach. Electrical parameters were similar between the two approaches. There were only two complications during jugular veinous implantations (1 pericardial effusion and 1 dislocation), compared to 16 complications using the femoral approach (1 pericardial effusion, 2 femoral artery injuries, and 13 major groin haematomas). CONCLUSION: The jugular approach may represent a safe and efficient alternative to femoral implantation of the Micra leadless pacemaker.

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We report the case of a 5-year-old girl who underwent left pneumonectomy for Ewing sarcoma of the lung. Two expandable prostheses were placed in the left hemi-thorax to prevent post-pneumonectomy syndrome and to protect the heart from radiotherapy. With a follow-up of 10 years, the procedure proved to be effective both on post-pneumonectomy syndrome and on cardiac protection.

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BACKGROUND: Recently a new surgical technique for intracorneal ring-segments (ICRS) assisted by femtosecond laser (FSL) called ByLimB was developed, involving the creation of the incision from a paralimbic region. This study aims to evaluate the safety and efficacy of the ByLimb technique following one year of follow-up. METHODS: A prospective, single-center study was conducted at the Zaldivar Institute in Buenos Aires, Argentina. Keratoconus patients with indication for ICRS-FSL assisted procedure, operated with the ByLimb technique were included. By using the ByLimb technique, the ICRS are placed without affecting the tunnel's roof, and the end of the ICRS is always away from the incision area. Visual acuity, topographic astigmatism, and the occurrence of complications were evaluated. Safety index was the main outcome and efficacy indes was a complimentary outcome. RESULTS: A total of 17 eyes completed the 12-month follow-up period. The safety index was 1.10 (mean postoperative corrected distance visual acuity (CDVA) in decimal: 0.76/preoperative CDVA: 0.69), while the efficacy index was 0.89 (mean postoperative uncorrected distance visual acuity UDVA in decimal: 0.62/preoperative CDVA: 0.69). Mean preoperative astigmatism was 5.3 ± 2.3, decreasing twelve months after surgery at 2.1 ± 1.2 (p < 0.001). No eye loss lines of vision and no intraoperative complications were observed. During the first month after surgery, an improper positioning of the ICRS based on topographic assessment was detected in five cases. A second procedure was performed, which consisted of opening the incision and introducing a Sinsky hook, through which the ICRS was mobilized and placed in its correct position. No incisional alterations, signs of infection, anterior segment anomalies, or fundus alterations were observed. CONCLUSION: FSL-assisted ICRS implantation through the perilimbal region has demonstrated an adequate safety index one year post-surgery. Additionally, this technique has facilitated accurate realignment of ICRS during secondary surgical interventions within one-month post-surgery. While the current findings are promising, continued follow-up of these cases is warranted.

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