Prosthesis Implantation

假体植入
  • 文章类型: Journal Article
    背景:这项研究回顾了在幼儿中植入主动式骨整合骨传导装置的可行性,低于FDA适应症的先前年龄(<12岁),最近减少到5年。结果包括两组(<12岁和12岁或以上)之间不良事件发生率和手术时间的差异。
    方法:本研究是对在三级转诊中心学术医院接受主动骨整合骨传导装置的儿童的回顾性研究。124名儿童接受了135个主动骨整合骨传导装置(2018年5月至2024年3月)。
    结果:在135台设备中,77(57%)的儿童年龄<12岁(平均年龄(SD)=7.9(2.0)岁,范围=4.9-11.9岁)和58(43%)在12岁或以上(平均年龄(SD)=15.1(1.7)岁,范围=12-18年)。老年组的不良事件明显较高,发生在12岁以下儿童的77个装置中的8个(10%)和12岁及以上儿童的58个装置中的15个(26%)(Fisher精确检验=0.0217,p<0.05)。主要不良事件发生在5/124(4%)患者中,<12岁患者2例(2/73,3%),12岁及以上儿童3例(3/51,6%)。两组间主要事件的比例无显著差异(Fisher精确检验=0.4,p<0.05)。与12岁及以上的儿童(平均(SD)=78.32(23.1)分钟)相比,<12岁的儿童(平均(SD)=66.5(22.4)分钟)的平均手术时间显着减少(t=-2.8799,df=120.26,p=0.005)。
    结论:在5岁以下的儿童中植入主动骨整合骨传导装置是可行的,并且并发症发生率低。进一步的小型化可以允许甚至更早的安全干预。
    BACKGROUND: 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).
    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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  • 文章类型: Journal Article
    手术后男性重度压力性尿失禁(MUI)的治疗方法是植入人工尿道括约肌(AUS)。传统上,你需要两个切口:会阴和腹股沟。我们的目标是通过会阴单切口使用Zephyr375EUA植入物治疗的一系列患者。我们介绍了六名在经尿道前列腺切除术(TURP)(1)和根治性前列腺切除术(5)后接受MUI手术的男子。术前我们进行垫测试和膀胱镜检查。在硬膜外麻醉下,做了一个垂直的会阴切口,切开直到球海绵状肌,我们切开了球尿道。取出探头后,我们放置袖口,检查它是否达到适当的压力,让它停用。要放置泵储液罐,我们用Vicryl3/0封闭的会阴数字化开发了阴囊dartos口袋。用3/0Vicryl关闭肌肉后,我们留下了一个抽吸引流管和一个膀胱导管.平均年龄为63岁(55-72)。平均手术时间为68分钟(60-85分钟)。第二天所有人都出院,没有导管和引流。所有患者都舒适地触诊了阴囊储液泵。激活后,所有患者都是大陆,不需要额外的调整,使用3个安全垫。满意度很高,他们都确认他们将再次接受同样的干预。Zephyr375尿道括约肌允许通过单个会阴切口放置,减少手术时间,简化技术,在不损害功能结果的情况下降低发病率。
    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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  • 文章类型: Journal Article
    目的:确定1型波士顿人工角膜手术后患者的临床结局以及超声生物显微镜成像对术后随访的意义。
    方法:这项回顾性分析包括2014年4月至2021年12月期间接受1型波士顿人工角膜角膜移植的19例患者的20只眼。患者人口统计数据,术前诊断,视敏度,并对术后临床表现进行分析。
    结果:1型波士顿人工角膜植入术产生了中期和长期的积极结果。然而,失明和其他严重并发症,如青光眼,假体后膜形成,眼内炎,或视网膜脱离也发生。使用超声生物显微镜成像可以更好地评估钛板的背面,前段结构,以及假体与周围组织的关系,这提供了有价值的术后信息。
    结论:对于接受波士顿1型人工角膜植入术的高危角膜移植患者,需要定期进行终生监测和治疗。超声生物显微镜成像可以成为评估波士顿1型人工角膜患者的一种有价值的成像技术,提供关于眼前节解剖结构和潜在并发症的重要信息。需要进一步的研究和术后随访方案的共识,以优化波士顿1型人工角膜患者的管理。
    OBJECTIVE: 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.
    CONCLUSIONS: 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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  • 文章类型: Journal Article
    暂无摘要。
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  • 文章类型: Journal Article
    背景:建立静脉通路是起搏器和除颤器(心脏可植入电子设备[CIED])植入过程中并发症的驱动因素之一。最近,已经描述了一种使用改良的Seldinger技术通过头静脉穿刺(CVP)进入头静脉的新方法,有前途的高成功率和简化的处理与更陡峭的学习曲线。在这个单中心注册表中,在我们中心将CVP定义为主要访问途径后,我们分析了CVP到SVP访问的安全性和效率.
    方法:共有229名接受aCIED的连续患者被纳入登记。61例患者通过初级或纾困SVP植入;168例患者接受了原发性头颅准备,并在可能的情况下进行了CVP,使用亲水的经桡骨鞘。
    结果:168例患者中有151例(90%)成功通过CVP植入至少一根导线,168例患者中有122例(72.6%)可以植入所有导线。CVP和SVP植入的总植入时间、透视时间和剂量没有差异。仅通过CVP植入的0/122例患者发生气胸,但8/107(7.5%)的患者通过SVP接受了至少一个引线。
    结论:我们的数据证实了CVP用于ED植入的高成功率。此外,与高效SVP相比,该方法可在不显著延长总手术时间或应用透视剂量的情况下使用,同时显示出总体并发症发生率较低.
    BACKGROUND: The establishment of venous access is one of the driving factors for complications during implantation of pacemakers and defibrillators (cardiac implantable electronic devices [CIED]). Recently, a novel approach of accessing the cephalic vein for CIED by cephalic vein puncture (CVP) using a modified Seldinger technique has been described, promising high success rates and simplified handling with steeper learning curves. In this single-center registry, we analyzed the safety and efficiency of CVP to SVP access after defining CVP as the primary access route in our center.
    METHODS: A total of 229 consecutive patients receiving a CIED were included in the registry. Sixty-one patients were implanted by primary or bail-out SVP; 168 patients received primary cephalic preparation and CVP was performed when possible, using a hydrophilic transradial sheath.
    RESULTS: Implantation of at least one lead via CVP was successful in 151 of 168 patients (90%), and implantation of all leads was possible in 122 of 168 patients (72.6%). Total implantation times and fluoroscopy times and doses did not differ between CVP and SVP implantations. Pneumothorax occurred in 0/122 patients implanted via CVP alone, but 8/107 (7.5%) patients received at least one lead via SVP.
    CONCLUSIONS: Our data confirms high success rates of the CVP for CIED implantation. Moreover, this method can be used without significantly prolonging the total procedure time or applying fluoroscopy dose compared to the highly efficient SVP while showing lower overall complication rates.
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  • 文章类型: Journal Article
    背景:无引线起搏器治疗是为了克服常规经静脉起搏器治疗中与引线和囊袋相关的并发症。经股静脉植入,然而,可能并不总是可行的。这项研究的目的是评估使用颈静脉入路的无引线起搏器植入,并将其与通过股静脉的标准植入方法进行比较。
    方法:本研究纳入了来自两个中心的连续100例通过右颈内静脉植入MicraTM无引线起搏器的患者的记录。将颈静脉入路的围手术期安全性和有效性与苏黎世大学医院接受股骨植入入路的前100例患者进行了比较。
    结果:100例患者通过颈内静脉成功植入无引线起搏器(平均年龄,81.18±8.29,60%男性)。平均手术时间为35.63±10.29min,平均透视时间为4.66±5.16min。该装置位于25例患者的下隔膜处,在24例的高间隔和51例的中间隔。在0.24ms脉冲宽度下,平均起搏阈值为0.56±0.35V,感知幅度为10.0±4.4mV。在后续行动中,所有患者的电参数保持稳定.与股骨植入相比,经颈静脉植入起搏器的患者年龄相似,合并症相似.平均手术时间(48.9±21.0分钟)和透视时间(7.7±7.8分钟,与股骨入路相比,两者p<0.01)均较短。两种方法之间的电参数相似。在颈静脉植入过程中只有两种并发症(1例心包积液和1例脱位),与使用股骨入路的16种并发症相比(1种心包积液,2例股动脉损伤和13例腹股沟大血肿)。
    结论:颈静脉入路可能是一种安全有效的替代股骨植入方法,用于植入Micra无引线起搏器。
    OBJECTIVE: 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.
    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).
    CONCLUSIONS: The jugular approach may represent a safe and efficient alternative to femoral implantation of the Micra leadless pacemaker.
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  • 文章类型: Journal Article
    植入物相关的感染和过度的免疫反应是成功植入的两个主要的术后问题。然而,包括抗生素治疗和炎症调节在内的常规策略总是由于各种生化试剂的共同修饰和功能干扰而受到损害.必须提供具有令人满意的抗菌和抗炎特性的植入物表面。这里,设计了具有仿生机械杀菌纳米柱和固定化免疫调节Zn2的双效应纳米结构聚醚醚酮(PEEK)表面(NP@PDA/Zn)。通过纳米柱和Zn2施加的物理和化学杀菌作用的协同作用,构建的混合纳米柱对革兰氏阴性和革兰氏阳性菌株具有显着的抗菌性能。同时,免疫调节特性是通过研究巨噬细胞极化在体外和体内,结果表明,NP@PDA/Zn可以下调M1相关细胞因子的表达,减少M1巨噬细胞的募集,从而降低炎症反应。值得注意的是,表面表现出特殊的生物相容性与辨别细菌和哺乳动物细胞之间的杀生物活性和抗氧化性能,有效清除ROS,最小化潜在的细胞毒性。一起来看,NP@PDA/Zn提出了一种方便且有前途的策略,可以将协同杀菌活性和炎症调节相结合,而无需任何相互干扰。这可以支持多功能植入物相关材料的开发。
    Implant-associated infections and excessive immune responses are two major postsurgical issues for successful implantation. However, conventional strategies including antibiotic treatment and inflammatory regulation are always compromised due to the comodification of various biochemical agents and instances of functional interference. It is imperative to provide implant surfaces with satisfactory antibacterial and anti-inflammatory properties. Here, a dual-effect nanostructured polyetheretherketone (PEEK) surface (NP@PDA/Zn) with bionic mechano-bactericidal nanopillars and immobilized immunomodulatory Zn2+ is designed. The constructed hybrid nanopillars display remarkable antibacterial performance against Gram-negative and Gram-positive strains through the synergy of physical and chemical bactericidal effects imposed by nanopillars and Zn2+. Meanwhile, the immunoregulatory property is evaluated through the investigation of macrophage polarization both in vitro and in vivo, and the results reveal that NP@PDA/Zn could downregulate the expression of M1-related cytokines and decrease the M1 macrophage recruitment to lower the inflammatory response. Notably, the surface exhibited exceptional biocompatibility with discerning biocidal activity between bacterial and mammalian cells and antioxidant performance that effectively scavenges ROS, minimizing potential cytotoxicity. Taken together, NP@PDA/Zn presents a convenient and promising strategy of combining synergistic bactericidal activity and inflammatory regulation without any mutual interference, which can support the development of multifunctional implant-associated materials.
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  • 文章类型: Journal Article
    背景:最近开发了一种由飞秒激光(FSL)辅助的角膜内环形段(ICRS)的新手术技术,称为ByLimB,涉及从旁缘区域创建切口。这项研究旨在评估ByLimb技术在随访一年后的安全性和有效性。
    方法:前瞻性,单中心研究是在布宜诺斯艾利斯的Zaldivar研究所进行的,阿根廷。有ICRS-FSL辅助手术指征的圆锥角膜患者,包括使用Bylimb技术进行手术。通过使用ByLimb技术,ICRS的放置不影响隧道的屋顶,ICRS的末端总是远离切口区域。视敏度,地形散光,并评估并发症的发生情况。安全指数是主要结果,疗效指标是互补结果。
    结果:共有17只眼完成了12个月的随访期。安全性指数为1.10(以十进制表示的平均术后矫正视力(CDVA):0.76/术前CDVA:0.69),而疗效指数为0.89(平均术后未矫正远距视力UDVA:0.62/术前CDVA:0.69)。术前平均散光为5.3±2.3,术后12个月为2.1±1.2(p<0.001)。未观察到视力丧失线和术中并发症。手术后的第一个月,在5例病例中发现了基于地形评估的ICRS定位不当。进行了第二个程序,包括打开切口和引入辛斯基钩,ICRS通过它被动员起来并处于正确的位置。无切口改变,感染的迹象,眼前段异常,或观察到眼底改变。
    结论:FSL辅助的ICRS在手术后1年通过周围区域植入已经证明了足够的安全指数。此外,这项技术有助于在术后1个月内的二次手术干预期间对ICRS进行准确的重新对齐.虽然目前的发现很有希望,有必要继续跟进这些病例。
    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.
    CONCLUSIONS: 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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  • 文章类型: Journal Article
    目的:比较在前列腺癌(PCa)放疗(RT)的患者中,人工尿道括约肌(AUS)的首次体囊(TC)放置与标准放置(SP)的寿命。
    方法:我们回顾了2011年1月至2021年1月1日来自两个高容量护理中心的首次(处女)AUS安置,包括有RT病史的PCa患者。AUS寿命是通过TC与TC在十年时间范围内的设备外植体和/或翻修的危险比来评估的。SP方法。卡方,费希尔的精确,和t检验比较了临床人口统计学变量。Kaplan-Meier曲线比较了TC和SP寿命。
    结果:85/314男性AUS符合纳入标准,TC组为38.8%(33/85),SP组为61.2%(52/85)。中位年龄为69.8(IQR=65.2-73.6)和67.1(61.6-72.9),分别,p=0.17。TC和SP的中位随访时间为51.9(15.8-86.1)和80.4(28.1-128.3)个月,总的来说,12(36.4%)TC设备被移除(由于机械故障,四个[12.1%];八个[24.2%]侵蚀,和两个[6.1%]感染)与SP组29例(55.8%)(14[26.9%]机械故障;11[21.1%]侵蚀,和五次[9.6%]感染)。两种方法之间没有观察到统计学上的显着差异,HR=0.717,95%CI0.37-1.44,p=0.35。TC与TC的计算设备生存概率SP在一个,五,10年是78.8%,而不是76.9%,69.3%与58.7%,和62.1%vs.46.7%,分别。
    结论:在预照射患者中进行首次AUS植入的TC袖带插入在装置存活方面与SP相当。并发症发生率相当。当前的方法选择指南主要基于患者选择和外科医生偏好。
    OBJECTIVE: 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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