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1.
J Fr Ophtalmol ; 46(10): 1212-1221, 2023 Dec.
Artículo en Francés | MEDLINE | ID: mdl-37867123

RESUMEN

BACKGROUND/PURPOSE: To evaluate long-term visual outcomes of Boston type I keratoprosthesis (KPro) surgery and identify risk factors for visual failure. METHODS: Single surgeon retrospective cohort study including 85 eyes of 74 patients who underwent KPro implantation to treat severe ocular surface disease, including limbal stem cell deficiency, postinfectious keratitis, aniridia and chemical burns. Procedures were performed at the Centre hospitalier de l'Université de Montréal from October 2008 to May 2012. All patients with at least 5 years of follow-up were included in the analysis, including eyes with repeated KPro. Main outcome measures were visual acuity (VA), visual failure, defined as a sustained VA worse than the preoperative VA, postoperative complications, and device retention. RESULTS: Mean follow-up was 7.2±1.3 years (±SD). Mean VA was 2.1±0.7 (logarithm of minimal angle resolution) preoperatively and 1.9±1.2 at last follow-up. In total, 2.4% of patients had VA better than 20/200 preoperatively vs. 36.5% at last follow-up. Maintenance of improved postoperative VA was seen in 61.8% of eyes at 7 years. Preoperative factors associated with visual failure were known history of glaucoma (HR=2.7 [1.2 to 5.9], P=0.02) and Stevens-Johnson syndrome (HR=7.3 [2.5 to 21.4], P<0.01). Cumulative 8-year complication rates were 38.8% retroprosthetic membrane formation, 25.9% hypotony, 23.5% new onset glaucoma, 17.6% retinal detachment, 8.2% device extrusion and 5.9% endophthalmitis. The majority (91.8%) of eyes retained the device 8 years after implantation. CONCLUSION: Nearly two-thirds of patients exhibited improved VA 7 years after KPro implantation. Preoperative risk factors for visual failure were known glaucoma and Stevens-Johnson syndrome.


Asunto(s)
Órganos Artificiales , Enfermedades de la Córnea , Glaucoma , Síndrome de Stevens-Johnson , Humanos , Córnea/cirugía , Prótesis e Implantes/efectos adversos , Enfermedades de la Córnea/epidemiología , Enfermedades de la Córnea/cirugía , Enfermedades de la Córnea/complicaciones , Estudios Retrospectivos , Síndrome de Stevens-Johnson/complicaciones , Órganos Artificiales/efectos adversos , Canadá , Glaucoma/epidemiología , Glaucoma/etiología , Glaucoma/cirugía , Implantación de Prótesis/efectos adversos , Implantación de Prótesis/métodos , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/cirugía , Estudios de Seguimiento
2.
Expert Rev Med Devices ; 20(7): 537-548, 2023 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-37232348

RESUMEN

INTRODUCTION: Fecal incontinence is a common chronic disease, which not only brings inconvenience to the lives of patients, but also causes great psychological harm to patients. Artificial anal sphincter is an innovative method that may treat fecal incontinence, and now has been clinically applied. AREAS COVERED: This article will review recent developments in mechanisms and clinical applications of artificial anal sphincter. The current results of clinical trials show that the implantation of artificial sphincter will cause morphological changes of surrounding tissues, and related biomechanical imbalance will lead to the loss of effectiveness of the device and various complications. In terms of safety, postoperative patients suffer from various complications such as infection, corrosion, tissue ischemia, mechanical failure, and difficulty in emptying. In terms of effectiveness, there is currently no long-term research data to prove that the implanted device can maintain a long-term functional state. EXPERT OPINION: The key issue for the safety and effectiveness of implantable devices is the biomechanical compatibility of implantable devices was proposed. Based on the superelasticity of shape memory alloy, this article proposes a new type of constant force artificial sphincter device, which provides a new direction for solving the clinical application of artificial anal sphincter.


Asunto(s)
Órganos Artificiales , Incontinencia Fecal , Humanos , Canal Anal/cirugía , Incontinencia Fecal/cirugía , Incontinencia Fecal/etiología , Órganos Artificiales/efectos adversos , Prótesis e Implantes/efectos adversos
3.
Acta Ophthalmol ; 101(2): 242-243, 2023 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-36794627

RESUMEN

Corneal blindness is a leading cause of visual impairment worldwide. The most common treatment is to replace the diseased cornea with standard corneal transplantation. In eyes at high risk of graft failure, the Boston keratoprosthesis type 1 (KPro) can be used to restore vision and is currently the most frequently used artificial cornea in the world. However, glaucoma is a well-known complication of KPro surgery and is the most important threat to vision in KPro-implanted eyes. This chronic disease is influenced by elevated intraocular pressure (IOP) and damages the optic nerve, leading to progressive vision loss. In KPro patients, glaucoma is highly prevalent and extremely challenging to manage, yet its exact cause remains unknown.


Asunto(s)
Órganos Artificiales , Enfermedades de la Córnea , Glaucoma , Humanos , Córnea/cirugía , Prótesis e Implantes/efectos adversos , Enfermedades de la Córnea/diagnóstico , Enfermedades de la Córnea/etiología , Enfermedades de la Córnea/cirugía , Implantación de Prótesis/efectos adversos , Glaucoma/etiología , Glaucoma/cirugía , Órganos Artificiales/efectos adversos , Estudios Retrospectivos
4.
Eye (Lond) ; 37(3): 486-491, 2023 02.
Artículo en Inglés | MEDLINE | ID: mdl-35169272

RESUMEN

BACKGROUND/OBJECTIVES: To compare long-term outcomes of the Boston type 1 keratoprosthesis (KPro) with penetrating keratoplasty (PKP) in patients with a failed first PKP. SUBJECTS/METHODS: In this retrospective comparative case series, 48 eyes of 48 patients who underwent a second corneal replacement procedure after a first failed PKP at the Centre Hospitalier de l'Université de Montréal from 2008 to 2020 were included. Minimum follow-up duration was 5 years, and patients with keratoconus were excluded since such subjects are not candidates for KPro. Main outcome measures included best-corrected visual acuity (BCVA), postoperative complications, graft survival and subsequent interventions. RESULTS: Mean follow-up was 6.4 years for PKP and 9.6 years for KPro (p < 0.001). Preoperative BCVA was better in PKP patients (means 1.67 vs 2.13, p = 0.041). Visual outcomes were similar between groups. KPro patients developed 0.263 complication per patient-year (ppy) compared to 0.245 ppy or PKP. The most common complications for PKP were corneal complications (0.088 ppy) and glaucoma worsening (0.041 ppy). In KPro, glaucoma worsening (0.046 ppy), vitreoretinal complications (0.042 ppy) and retroprosthetic membrane (0.042 ppy) were the most frequent. Graft failure (69.6 vs 20.0%, p < 0.001) and reoperation rates (56.5 vs 12.0%, p = 0.001) were significantly higher for PKP. Failure mainly resulted from decompensation or rejection in PKP, while all five failures in KPro were caused by melt and/or extrusion. CONCLUSIONS: Both interventions showed similar visual outcomes. Complication profiles were different, with more posterior segment complications in the KPro group, and more corneal complications in the PKP group, often necessitating regraft.


Asunto(s)
Órganos Artificiales , Enfermedades de la Córnea , Glaucoma , Queratocono , Humanos , Córnea/cirugía , Queratoplastia Penetrante/métodos , Estudios Retrospectivos , Prótesis e Implantes , Enfermedades de la Córnea/cirugía , Órganos Artificiales/efectos adversos , Agudeza Visual , Glaucoma/cirugía , Complicaciones Posoperatorias/etiología , Queratocono/cirugía , Implantación de Prótesis
5.
Cornea ; 41(8): 950-957, 2022 Aug 01.
Artículo en Inglés | MEDLINE | ID: mdl-35184127

RESUMEN

PURPOSE: Glaucoma is a cause of comorbidity in patients receiving the Boston keratoprosthesis (KPro). The aim of this study was to report the outcomes of the Boston KPro with or without glaucoma surgery. METHODS: This was a retrospective single-center cohort study. Patients who underwent Boston KPro from March 2009 to February 2019 were included. One eye per patient (the first surgery) was included in this study. Patients were classified into 2 groups: KPro only (group 1) and KPro with any form of glaucoma procedure (group 2). Main outcome measures were Best-corrected visual acuity (BCVA), functional success (BCVA 20/200 or better), anatomical success (retention of KPro at the last follow-up), and complications. RESULTS: Seventy-one eyes were included: 27 eyes (38%) in group 1 and 44 (62%) in group 2. There was no statistically significant difference in BCVA between groups 1 and 2 at each time point. Of the eyes in group 1, 11% lost light perception vision and 4.5% in group 2 ( P = 0.293). There was no difference in anatomical success with 70% in group 1 and 77% in group 2 ( P = 0.703) at the last follow-up, with a median failure time of 18 months. The functional success was 48% for group 1 and 50% for group 2 ( P = 0.541). CONCLUSIONS: Eyes undergoing KPro with glaucoma surgery before or at the same time carry a similar functional and anatomical success to eyes without glaucoma surgery.


Asunto(s)
Órganos Artificiales , Enfermedades de la Córnea , Glaucoma , Órganos Artificiales/efectos adversos , Estudios de Cohortes , Córnea , Estudios de Seguimiento , Glaucoma/etiología , Glaucoma/cirugía , Humanos , Prótesis e Implantes , Implantación de Prótesis , Estudios Retrospectivos , Agudeza Visual
6.
Br J Ophthalmol ; 106(6): 781-785, 2022 06.
Artículo en Inglés | MEDLINE | ID: mdl-33674425

RESUMEN

PURPOSE: To report the long-term outcomes of Boston keratoprosthesis type I (B-KPro type I) implantation in the management of severe ocular surface disorders. METHODS: Retrospective case series. Patients who underwent B-KPro type I implantation at the People's Liberation Army General Hospital were enrolled between March 2011 and September 2019. Data regarding visual acuity (VA), B-KPro type I retention and postoperative complications were recorded and analysed. RESULTS: A total of 103 eyes of 100 patients who underwent B-KPro type I implantation were included. The main indications were chemical burn (59.2%), ocular trauma (25.2%), herpetic keratitis (11.7%) and autoimmune diseases (3.9%). The percentage of eyes with postoperative VA of 10/200 or better was 82.7% at 6 months, 82.8% at 12 months, 77.9% at 2 years, 72.4% at 3 years, 71.1% at 4 years, 69.4% at 5 years, 58.9% at 6 years, 56.8% at 7 years and 42.9% at 8 years. Preoperatively, 8.7% eyes were diagnosed with new-onset glaucoma. Retroprosthetic membrane formation occurred in 19.4% eye. Corneal melting occurred in 18.4% eyes. Sterile vitritis was diagnosed in 4.9% eyes and infectious endophthalmitis in 2.9% eyes. Retinal detachment occurred in 0.9% eyes. CONCLUSIONS: In a Chinese patient group, B-KPro type I is a viable option for treating severe ocular surface disorders in eyes where conventional keratoplasty would have a poor prognosis, especially in patients with chemical and thermal burns. Improved visual outcomes and high retention rate can be achieved and maintained in most cases.


Asunto(s)
Órganos Artificiales , Enfermedades de la Córnea , Endoftalmitis , Órganos Artificiales/efectos adversos , China/epidemiología , Córnea/cirugía , Enfermedades de la Córnea/etiología , Enfermedades de la Córnea/cirugía , Endoftalmitis/etiología , Hospitales Generales , Humanos , Complicaciones Posoperatorias/etiología , Prótesis e Implantes , Implantación de Prótesis , Estudios Retrospectivos , Resultado del Tratamiento
7.
Am J Ophthalmol ; 235: 249-257, 2022 03.
Artículo en Inglés | MEDLINE | ID: mdl-34543660

RESUMEN

PURPOSE: To determine the role and optimal timing of glaucoma surgery in relation to Boston keratoprosthesis type 1 (KPro) implantation. DESIGN: Retrospective, comparative, nonrandomized clinical study. METHODS: Single-center study of a total of 100 eyes (100 patients) implanted with a KPro between 2008 and 2017, and diagnosed with glaucoma before or after KPro. Patients were separated into 2 groups: those with preexisting glaucoma and those who developed de novo glaucoma after KPro. Groups were then divided based on whether patients were medically or surgically managed. Glaucoma surgery included glaucoma drainage device (GDD) implantation, trabeculectomy, and cyclophotocoagulation (CPC). Primary outcomes included best-corrected visual acuity (BCVA), glaucoma progression, and complications. Differences in outcomes were compared using parametric and nonparametric tests, as well as log-rank test to compare time-to-outcome events. RESULTS: Among 72 eyes with preexisting glaucoma, 27 (38%) had glaucoma surgery before KPro (18 GDD), whereas 45 (62%) were medically managed only. Among the latter, 19 (42%) needed glaucoma surgery post-KPro (16 GDD). Among 28 eyes with de novo glaucoma, 12 (43%) had glaucoma surgery post-KPro (9 GDD). For eyes with preexisting glaucoma, glaucoma progression was greater with glaucoma surgery performed post-KPro (100%) compared with pre-KPro (74%, P = .016) and to medical management (54%, P = .002). No increase in complications were observed with glaucoma surgery compared to medications only (P > .05), whereas fewer eyes maintained a BCVA of 20/200 or better over time with medical management (P = .013). Eyes with de novo glaucoma had similar progression, BCVA, and complications between medical and surgical care (P > .05). CONCLUSIONS: Glaucoma surgery should be performed before or at the same time as KPro implantation in eyes with preexisting glaucoma. Complication rates are not increased when glaucoma surgery is performed in KPro eyes with either preexisting or de novo glaucoma. To ensure optimal glaucoma control, glaucoma surgery should be performed as early as possible in KPro eyes with good visual potential.


Asunto(s)
Órganos Artificiales , Enfermedades de la Córnea , Implantes de Drenaje de Glaucoma , Glaucoma , Órganos Artificiales/efectos adversos , Córnea/cirugía , Enfermedades de la Córnea/complicaciones , Enfermedades de la Córnea/diagnóstico , Enfermedades de la Córnea/cirugía , Glaucoma/diagnóstico , Implantes de Drenaje de Glaucoma/efectos adversos , Humanos , Complicaciones Posoperatorias/cirugía , Prótesis e Implantes/efectos adversos , Implantación de Prótesis/efectos adversos , Estudios Retrospectivos , Agudeza Visual
8.
Cornea ; 41(6): 751-756, 2022 Jun 01.
Artículo en Inglés | MEDLINE | ID: mdl-34620769

RESUMEN

PURPOSE: The purpose of this study was to evaluate the incidence, rate of formation, and risk factors of retroprosthetic membrane (RPM) after Boston type 1 keratoprosthesis (BKPro) as well as identify secondary complications linked to its formation and describe its treatment. METHODS: This was a retrospective cohort study. One hundred thirty-three eyes of 115 patients who underwent BKPro implantation at the Centre Hospitalier de l'Université de Montréal from 2008 to 2017 were included with at least 1-year follow-up. Charts were reviewed, and data were collected, including incidence of RPM formation, preoperative and intraoperative risk factors, postoperative complications, and treatment modalities. RESULTS: The mean follow-up was 5.5 years, and 39% (n = 52) of eyes developed RPM. No etiologies were found to be significantly associated with RPM development. Simultaneous lensectomy and simultaneous intraocular lens extraction were respectively positively and negatively correlated with RPM development [odds ratio (OR): 0.3590, 95% CI: 0.1629-0.7570, P = 0.0097; OR = 2.646, 95% CI: 1.273-5.585, P = 0.0086, respectively]. As for postoperative complications, the strongest correlation was between RPM and retinal detachment (OR = 6.16, 95% CI: 2.14-16.14; P = 0.0004). RPM development was also positively associated with the development of hypotony and corneal melt. Nd:YAG membranectomy was the most common treatment, performed in 83% of eyes with RPM (n = 24), with 58% resolution. CONCLUSIONS: More than one third of patients who undergo BKPro will develop RPM, requiring close monitoring for retinal detachment. Simultaneous intraocular lens extraction seems protective, whereas simultaneous lens extraction increases the rate of RPM formation significantly. Nd:YAG membranectomy can be used as an initial noninvasive approach.


Asunto(s)
Órganos Artificiales , Enfermedades de la Córnea , Desprendimiento de Retina , Órganos Artificiales/efectos adversos , Córnea/cirugía , Enfermedades de la Córnea/epidemiología , Enfermedades de la Córnea/etiología , Enfermedades de la Córnea/cirugía , Humanos , Incidencia , Complicaciones Posoperatorias/epidemiología , Prótesis e Implantes/efectos adversos , Estudios Retrospectivos , Factores de Riesgo
11.
Am J Ophthalmol ; 206: 256-263, 2019 10.
Artículo en Inglés | MEDLINE | ID: mdl-30849343

RESUMEN

PURPOSE: To analyze the dynamics of telemetrically measured intraocular pressure (IOP) during the first year after implantation of a Boston keratoprosthesis type I (BI-KPro) cornea and to compare agreement of telemetric IOP measurements with finger palpations. DESIGN: Prospective, open-label, multicenter, single-arm clinical trial. METHODS: In the ARGOS (NCT02945176) study, 12 individuals underwent implantation of an Eyemate-IO intraocular system. Follow-up after surgery took place 12 months later with 13 visits planned per patient. During BI-KPro surgery, an electromagnetic induction sensor ring enabling telemetric IOP data transfer to a hand-held reading device outside the eye was implanted into the ciliary sulcus with or without trans-scleral suture fixation. Comprehensive ophthalmic examinations and IOP assessments through the telemetric system were compared to IOP assessed by finger palpation by 2 experts. RESULTS: Preoperative IOP measured by Goldmann tonometry was 13.4 ± 6.2 mm Hg. Telemetric IOP peaked at 23.1 ± 16.5 mm Hg at the first postoperative day. On day 5, mean IOP was 16.0 ± 5.2 mm Hg and 20.95 ± 6.5 mm Hg after 6-12 months. IOP estimation by finger palpation was grouped in 4 categories: normal, A; soft/hypotonic, B; borderline, C; and hypertonic, D. Mean telemetric IOP was 18.2 ± 6.1 mm Hg in category A, 8.9 ± 2.8 mm Hg in B, 22.4 ± 4.9 mm Hg in C, and 34.3 ± 11.0 mm Hg in D. Differences in mean telemetric IOPs per category were statistically significant (P < .001). Daily IOP fluctuations and peaks could be identified. CONCLUSIONS: Telemetric IOP assessment seems to be able to identify postoperative IOP peaks and a longitudinal increase of IOP after BI-KPro surgery. IOP measurements using the telemetric Eyemate-IO sensor showed a satisfactory agreement with those of finger palpations by 2 experts.


Asunto(s)
Órganos Artificiales/efectos adversos , Enfermedades de la Córnea/cirugía , Glaucoma/diagnóstico , Presión Intraocular/fisiología , Procedimientos Quirúrgicos Oftalmológicos/efectos adversos , Telemetría/métodos , Tonometría Ocular/métodos , Adolescente , Adulto , Enfermedades de la Córnea/fisiopatología , Femenino , Estudios de Seguimiento , Glaucoma/etiología , Glaucoma/fisiopatología , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias , Estudios Prospectivos , Reproducibilidad de los Resultados , Agudeza Visual , Adulto Joven
12.
Graefes Arch Clin Exp Ophthalmol ; 257(4): 769-783, 2019 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-30656473

RESUMEN

PURPOSE: To investigate the inflammatory response of current and future potential vitreous substitutes in an experimental in vivo vitrectomy model. METHODS: Twenty-five gauge pars plana vitrectomy was performed in the right eye of 60 pigmented rabbits, with subsequent injection of 0.5-1.0 ml of Healaflow® (cross-linked hyaluronic acid, n = 12), Bio-Alcamid® (polyalkylimide, n = 8), silicone oil (n = 12), or balanced saline solution (BSS, n = 28). Postoperative clinical evaluation was performed; and the rabbits were sacrificed at 1 day, 1 week, or 1 month. The eyecups were then examined macroscopically; the retinas sectioned and stained with hematoxylin and eosin (Htx), and immunohistochemically labeled for glial fibrillary acidic protein (GFAP), CD45, galectin-3, CD68, and CD20. Unoperated left eyes from treated animals as well as eyes from untreated animals were used as controls. RESULTS: Vitrectomy without major complications was achieved in 46/60 eyes. The remaining 14 eyes were analyzed separately. One eye developed endophthalmitis after 1 week and was excluded. Eyes treated with Healaflow®, silicone oil, and BSS had a comparable appearance macroscopically and in Htx-stained sections, whereas Bio-Alcamid®-injected eyes exhibited increased macroscopic inflammation and severely affected retinas. GFAP upregulation was present in all treatment groups, most prominent in eyes treated with Bio-Alcamid® and silicone oil. Upregulation of CD45 and CD68 in the inner retina and vitreous space was most prominent with Bio-Alcamid® treatment, and these eyes together with their silicone oil-treated counterparts also displayed a stronger upregulation of CD20-labeled cells compared with remaining groups. General upregulation of galectin-3, mainly in the inner retina, was found in all groups. In eyes with perioperative complications, labeling of CD45, CD68, and especially GFAP was comparably high. CONCLUSIONS: We here describe differences in the postsurgery inflammatory profiles of existing and potential vitreous substitutes. Bio-Alcamid® and silicone oil display severe signs of gliosis and inflammation, whereas Healaflow® elicits minimal reactions comparable with BSS, highlighting its potential application as a vitreous substitute in a future clinical setting.


Asunto(s)
Resinas Acrílicas , Órganos Artificiales/efectos adversos , Ácido Hialurónico , Inflamación/etiología , Aceites de Silicona , Vitrectomía/métodos , Cuerpo Vítreo , Acetatos , Animales , Antígenos CD/metabolismo , Materiales Biocompatibles/efectos adversos , Combinación de Medicamentos , Endoftalmitis/etiología , Endoftalmitis/metabolismo , Endotaponamiento , Galectina 3/metabolismo , Proteína Ácida Fibrilar de la Glía/metabolismo , Inflamación/metabolismo , Minerales , Modelos Animales , Conejos , Cloruro de Sodio
13.
Artif Organs ; 42(7): 746-755, 2018 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-29608016

RESUMEN

Shear-induced hemolysis is a major concern in the design and optimization of blood-contacting devices. Even with a small amount of mechanical stress, inflammatory reactions can be triggered in the cells. Blood damage is typically estimated using continuum fluid dynamics simulations. In this study, we report a novel cell damage index (CDI) obtained by simulations on the single-cell level in a lattice Boltzmann fluid flow. The change of the cell surface area gives important information on mechanical stress of individual cells as well as for whole blood. We are using predefined basic channel designs to analyze and compare the newly developed CDI to the conventional blood damage calculations in very weak shear stress scenarios. The CDI can incorporate both volume fraction and channel geometry information into a single quantitative value for the characterization of flow in artificial chambers.


Asunto(s)
Células Sanguíneas/citología , Simulación por Computador , Ensayo de Materiales , Modelos Biológicos , Órganos Artificiales/efectos adversos , Células Sanguíneas/patología , Velocidad del Flujo Sanguíneo , Comunicación Celular , Diseño de Equipo , Eritrocitos/citología , Eritrocitos/patología , Circulación Extracorporea/efectos adversos , Circulación Extracorporea/instrumentación , Hematócrito , Hemodinámica , Hemólisis , Humanos , Hidrodinámica , Dispositivos Laboratorio en un Chip/efectos adversos , Modelos Cardiovasculares , Estrés Mecánico
14.
Am J Ophthalmol ; 181: 46-54, 2017 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-28662941

RESUMEN

PURPOSE: To determine the incidence rate, principal causes, and clinical course of eyes developing no light perception (NLP) visual acuity (VA) following Boston Keratoprosthesis (B-KPro) type 1 surgery. Secondary objectives include determining the incidence rate, relative risk (RR), and survival probability with respect to NLP outcomes among eyes with congenital aniridia. DESIGN: Retrospective, interventional case series. SUBJECTS: All patients undergoing B-KPro type 1 surgery between October 2008 and June 2016 by a single surgeon at CHUM - Hôpital Notre-Dame. METHODS: Records of patients having undergone B-KPro implantation were reviewed. Eyes with a final outcome of NLP were further reviewed to determine best recorded postoperative VA, time to NLP onset, clinical course, and principal cause. Descriptive statistics, incidence rates, Kaplan-Meier survival curves, and the RR of NLP outcomes among eyes with aniridia were determined. Statistical significance was defined as P < .05. RESULTS: Records of 119 patients were included, with an average follow-up of 49.1 ± 26.8 months postoperatively. Nineteen eyes had a final outcome of NLP, representing 16.0%. The incidence rate of NLP was 0.04 cases per eye-year of follow-up. The most common principal causes were inoperable retinal detachment (n = 7, 36.8%), terminal glaucoma (n = 6, 31.6%), and carrier graft melt-related complications (n = 5, 26.3%). The RR of developing NLP among eyes with aniridia was 3.04 (P = .01). CONCLUSIONS: No light perception is a devastating but uncommon outcome of B-KPro surgery. Patients with aniridia seem to be at increased risk. In spite of all available medical and surgical interventions, some eyes may still suffer this outcome.


Asunto(s)
Órganos Artificiales/efectos adversos , Ceguera/epidemiología , Córnea , Prótesis e Implantes/efectos adversos , Implantación de Prótesis/efectos adversos , Adulto , Anciano , Aniridia/complicaciones , Ceguera/etiología , Femenino , Estudios de Seguimiento , Glaucoma/complicaciones , Humanos , Incidencia , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Desprendimiento de Retina/complicaciones , Estudios Retrospectivos , Factores de Riesgo , Agudeza Visual/fisiología
15.
Artif Organs ; 41(9): 845-851, 2017 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-28718924

RESUMEN

Artificial anal sphincter (AAS) is an in situ implanted device that acts as a treatment for fecal incontinence regardless of etiology by augmenting the incompetent sphincteric structures. However, AAS is impeded from becoming a valid therapy by its high rate of ischemic complication and malfunction. This article presents an original puborectalis-like artificial anal sphincter (PAAS) that features a low risk of ischemia necrosis and rectal perception remodeling. The device retains continence by reproducing the action, including the pulling and angulating the rectum, of the puborectalis muscle, which forms the anorectal angle and reduces the required clamping pressure. Three rectal pressure sensors were embedded to maintain the pressure exerted on the rectal wall in a safe range and to monitor the distention of the rectum. A series of in vitro studies were conducted with a porcine rectum, and this PAAS prototype manifested the ability of maintaining continence with a clamping pressure considerably lower than that required by other AAS devices. The pressure sensors exhibit good linearity, and the function of rectal perception remodeling has also revealed high reliability with a success rate of 93.3%.


Asunto(s)
Canal Anal/cirugía , Órganos Artificiales/efectos adversos , Incontinencia Fecal/cirugía , Diseño de Prótesis , Canal Anal/fisiopatología , Materiales Biocompatibles , Estudios de Factibilidad , Incontinencia Fecal/fisiopatología , Humanos , Isquemia/etiología , Presión , Falla de Prótesis/efectos adversos , Recto/fisiología , Recto/cirugía , Reproducibilidad de los Resultados
17.
Artif Organs ; 41(3): 276-304, 2017 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-28281283

RESUMEN

In this Editor's Review, articles published in 2016 are organized by category and briefly summarized. We aim to provide a brief reflection of the currently available worldwide knowledge that is intended to advance and better human life while providing insight for continued application of technologies and methods of organ Replacement, Recovery, and Regeneration. As the official journal of The International Federation for Artificial Organs, The International Faculty for Artificial Organs, the International Society for Mechanical Circulatory Support, the International Society for Pediatric Mechanical Cardiopulmonary Support, and the Vienna International Workshop on Functional Electrical Stimulation, Artificial Organs continues in the original mission of its founders "to foster communications in the field of artificial organs on an international level." Artificial Organs continues to publish developments and clinical applications of artificial organ technologies in this broad and expanding field of organ Replacement, Recovery, and Regeneration from all over the world. We were pleased to publish our second Virtual Issue in April 2016 on "Tissue Engineering in Bone" by Professor Tsuyoshi Takato. Our first was published in 2011 titled "Intra-Aortic Balloon Pumping" by Dr. Ashraf Khir. Other peer-reviewed Special Issues this year included contributions from the 11th International Conference on Pediatric Mechanical Circulatory Support Systems and Pediatric Cardiopulmonary Perfusion edited by Dr. Akif Ündar and selections from the 23rd Congress of the International Society for Rotary Blood Pumps edited by Dr. Bojan Biocina. We take this time also to express our gratitude to our authors for offering their work to this journal. We offer our very special thanks to our reviewers who give so generously of time and expertise to review, critique, and especially provide meaningful suggestions to the author's work whether eventually accepted or rejected. Without these excellent and dedicated reviewers the quality expected from such a journal could not be possible. We also express our special thanks to our Publisher, John Wiley & Sons for their expert attention and support in the production and marketing of Artificial Organs. We look forward to reporting further advances in the coming years.


Asunto(s)
Órganos Artificiales , Materiales Biocompatibles Revestidos , Ingeniería de Tejidos/métodos , Animales , Órganos Artificiales/efectos adversos , Coagulación Sanguínea , Materiales Biocompatibles Revestidos/efectos adversos , Hemólisis , Humanos , Publicaciones Periódicas como Asunto , Diseño de Prótesis , Trombosis/sangre , Trombosis/etiología , Trombosis/prevención & control
18.
J Biol Regul Homeost Agents ; 30(2 Suppl 2): 27-34, 2016.
Artículo en Inglés | MEDLINE | ID: mdl-27373131

RESUMEN

Ensuring the safety of hair implant fibers is essential. At the same time, good aesthetic quality and durability should also be considered in order to maintain expected result over the years. The main features required are biocompatibility, resistance to traction, absence of capillarity, resistance to physical-chemical stress, and low tissue trauma, in addition to good aesthetics. Biofibre® medical hair prosthetic fibers meet all the biocompatibility and safety requirements established by international standards for medical devices. They are available in 13 colors, with different lengths (15, 30 or 45 cm) and various shapes (straight, wavy, curly and afro). Biofibre® hair implants are indicated for diffuse hair loss or hair thinning in cases where an immediate aesthetic result is required, when patients request minor surgery without hospitalization, both for male and female patients, in combination with other hair restoration techniques to improve the final aesthetic result, to correct scars or scalp burns and in cases of poor donor areas. Biofibre® Hair Implant is in fact a minor surgery technique, performed under local anesthesia by either a manual implanter or an automatic machine which enables an immediate aesthetic result and the desired quantity of hair without pain or hospitalization. Clinical and histological studies have demonstrated that Biofibre® hair Implants are safe and well tolerated by patients and can be totally reversible if the need arises. This technique requires good after-care, periodical check-ups and yearly implant re-touches to maintain the best cosmetic result.


Asunto(s)
Alopecia Areata/cirugía , Órganos Artificiales , Cabello , Prótesis e Implantes , Órganos Artificiales/efectos adversos , Femenino , Humanos , Masculino , Prótesis e Implantes/efectos adversos , Cirugía Plástica/efectos adversos
19.
Invest Ophthalmol Vis Sci ; 57(4): 2195-202, 2016 Apr 01.
Artículo en Inglés | MEDLINE | ID: mdl-27116547

RESUMEN

PURPOSE: Discomfort from light exposure leads to photophobia, glare, and poor vision in patients with congenital or trauma-induced iris damage. Commercial artificial iris lenses are static in nature to provide aesthetics without restoring the natural iris's dynamic response to light. A new photo-responsive artificial iris was therefore developed using a photochromic material with self-adaptive light transmission properties and encased in a transparent biocompatible polymer matrix. METHODS: The implantable artificial iris was designed and engineered using Photopia, a class of photo-responsive materials (termed naphthopyrans) embedded in polyethylene. Photopia was reshaped into annular disks that were spin-coated with polydimethylsiloxane (PDMS) to form our artificial iris lens of controlled thickness. RESULTS: Activated by UV and blue light in approximately 5 seconds with complete reversal in less than 1 minute, the artificial iris demonstrates graded attenuation of up to 40% of visible and 60% of UV light. There optical characteristics are suitable to reversibly regulate the incident light intensity. In vitro cell culture experiments showed up to 60% cell death within 10 days of exposure to Photopia, but no significant cell death observed when cultured with the artificial iris with protective encapsulation. Nuclear magnetic resonance spectroscopy confirmed these results as there was no apparent leakage of potentially toxic photochromic material from the ophthalmic device. CONCLUSIONS: Our artificial iris lens mimics the functionality of the natural iris by attenuating light intensity entering the eye with its rapid reversible change in opacity and thus potentially providing an improved treatment option for patients with iris damage.


Asunto(s)
Órganos Artificiales , Iris , Órganos Artificiales/efectos adversos , Ingeniería Biomédica , Células Cultivadas , Córnea/citología , Córnea/efectos de los fármacos , Humanos , Iris/fisiología , Iris/efectos de la radiación , Luz , Espectroscopía de Resonancia Magnética , Óptica y Fotónica , Rayos Ultravioleta
20.
Int J Artif Organs ; 39(1): 37-44, 2016 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-26916758

RESUMEN

BACKGROUND: The inflammatory responses evoked by artificial organs and implantation of devices like biosensors and guide wires can lead to acute and chronic inflammation, largely limiting the functionality and longevity of the devices with negative effects on patients. AIMS: The present study aimed to reduce the inflammatory responses to biomaterials by covalent immobilization of glycosaminoglycans (GAGs) on amino-terminated surfaces used as model biomaterials here. METHODS AND RESULTS: Water contact angle (WCA) and zeta potential measurements showed a significant increase in wettability and negative charges on the GAG-modified surfaces, respectively, confirming the successful immobilization of GAGs on the amino-terminated surfaces. THP-1-derived macrophages were used as a model cell type to investigate the efficacy of GAG-modified surfaces in modulating inflammatory responses. It was found that macrophage adhesion, macrophage spreading morphology, foreign body giant cell (FBGC) formation, as well as ß1 integrin expression and interleukin-1ß (IL-1ß) production were all significantly decreased on GAG-modified surfaces compared to the initial amino-terminated surface. CONCLUSIONS: This study demonstrates the potential of covalent GAG immobilization to reduce the inflammatory potential of biomaterials in different clinical settings.


Asunto(s)
Materiales Biocompatibles/efectos adversos , Glicosaminoglicanos/farmacología , Inflamación/prevención & control , Prótesis e Implantes/efectos adversos , Propiedades de Superficie , Órganos Artificiales/efectos adversos , Células Cultivadas , Equipos y Suministros/efectos adversos , Humanos , Inflamación/etiología , Macrófagos/efectos de los fármacos , Macrófagos/metabolismo , Ensayo de Materiales , Células TH1/efectos de los fármacos , Células TH1/metabolismo
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