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1.
World J Urol ; 42(1): 273, 2024 Apr 30.
Artigo em Inglês | MEDLINE | ID: mdl-38689135

RESUMO

PURPOSE: The purpose of this study is to evaluate the incidence, risk factors, and salvage management of retrievable covered expandable metallic stent (RCEMS) migration in patients with persistent benign ureter strictures. MATERIALS AND METHODS: A retrospective study was performed on 117 consecutive patients who underwent implantation of RCEMS. Univariate and multivariate analyses were used to identify prognostic factors for stent migration, including stricture location and length, hydronephrosis-cortex ratio, ureteral dilation, and the diameter of the narrowest portion of the stricture. RESULTS: Stent migration occurred in 22 (19.5%) of 113 patients who met inclusion criteria. Of the 22 patients, 16 (72.7%) had ordinary ureteral stricture, 3 (13.6%) had stricture in transplanted kidneys, and 3 patients (13.6%) had ureter stricture in orthotopic neobladders. The mean creatinine for the entire cohorts showed significant improvement (p = 0.038). Multivariate analysis identified the following prognostic factors for migration: distal ureteral stricture (p = 0.006), patients who underwent balloon dilation (p = 0.003), hydronephrosis-cortex ratio ≧10 (p = 0.017), larger diameter of wasting of RCEMS (p < 0.001), and patients with a shorter stricture length (p = 0.006). Salvage management was required in 4 of the 22 patients. The strictures in the remaining 18 patients improved with observation. CONCLUSIONS: Stent migration is more likely to occur in patients with the five prognostic factors mentioned above. Our study developed a nomogram to predict stent migration in patients with ureteral strictures treated using RCEMS.


Assuntos
Migração de Corpo Estranho , Obstrução Ureteral , Humanos , Masculino , Estudos Retrospectivos , Obstrução Ureteral/etiologia , Obstrução Ureteral/terapia , Obstrução Ureteral/cirurgia , Feminino , Pessoa de Meia-Idade , Migração de Corpo Estranho/epidemiologia , Fatores de Risco , Adulto , Idoso , Remoção de Dispositivo , Stents Metálicos Autoexpansíveis , Falha de Prótese , Constrição Patológica , Stents/efeitos adversos , Desenho de Prótese , Adulto Jovem
2.
Int Urol Nephrol ; 55(6): 1467-1475, 2023 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-36976419

RESUMO

BACKGROUND: Robotic-assisted laparoscopic prostatectomy (RALP) is the most preferred intervention for the management of prostatic malignancy worldwide. Hem-o-Lok clips (HOLC) are widely used for haemostasis and lateral pedicle ligation. These clips are prone to migrate and lodge at the anastomotic junction as well as inside the bladder causing lower urinary tract symptoms (LUTS) secondary to bladder neck contracture (BNC) or bladder calculi. The objective of this study is to describe the incidence, clinical presentation, management, and outcome of HOLC migration. METHODOLOGY: Retrospective analysis of the database of Post RALP patients who developed LUTS secondary to HOLC migration was done. Cystoscopy findings, number of procedures required, number of HOLC removed intra-operatively, and follow-up of the patients was reviewed. RESULTS: The incidence of HOLC migration requiring intervention was 1.78% (9/505). The mean age of the patient, BMI, Pre-operative Serum PSA were 62.8 years, 27.8 kg/m2, and 9.8 ng/mL, respectively. The mean duration of appearance of symptoms due to HOLC migration was 9 months. Two patients presented with Haematuria and 7 presented with LUTS. Seven patients required a single intervention while 2 required up to 6 procedures for recurrent symptoms secondary to recurrent HOLC migration. CONCLUSION: HOLC use in RALP may present with migration and associated complications. HOLC migration is associated with severe BNC and may require multiple endoscopic interventions. Severe dysuria and LUTS not responding to medical management should be treated using an algorithmic approach and there should be a low threshold for performing cystoscopy and intervention in these cases to improve outcomes.


Assuntos
Migração de Corpo Estranho , Laparoscopia , Sintomas do Trato Urinário Inferior , Procedimentos Cirúrgicos Robóticos , Masculino , Humanos , Pessoa de Meia-Idade , Bexiga Urinária/cirurgia , Procedimentos Cirúrgicos Robóticos/efeitos adversos , Estudos Retrospectivos , Migração de Corpo Estranho/epidemiologia , Migração de Corpo Estranho/etiologia , Prostatectomia/efeitos adversos , Prostatectomia/métodos , Laparoscopia/efeitos adversos , Laparoscopia/métodos , Instrumentos Cirúrgicos/efeitos adversos , Sintomas do Trato Urinário Inferior/cirurgia
3.
J Vasc Surg Venous Lymphat Disord ; 10(2): 482-490, 2022 03.
Artigo em Inglês | MEDLINE | ID: mdl-35026448

RESUMO

BACKGROUND: Percutaneous endovenous stenting has emerged during the past decade as the primary method of treating symptomatic venous outflow obstruction. A recognized complication of venous stenting is stent migration. The aim of the present systematic review was to identify the number of cases of stent migration in reported studies to recognize the risk factors that might be associated with this complication and the outcomes following migration. METHODS: A review was conducted in accordance with the MOOSE (meta-analyses of observational studies in epidemiology) and PRIMSA (preferred reporting items for systematic review and meta-analysis) guidelines and registered in the PROSPERO. MEDLINE, EMBASE, and PubMed databases. Key references were searched using specified keywords. All relevant data for the primary procedure and subsequent presentation with stent migration were retrieved. The data were assessed as too low in quality to allow for statistical analysis. RESULTS: Between 1994 and 2020, 31 studies were identified, including 29 case reports and 2 case series, providing data for 54 events of venous stent migration with some data provided regarding the stent used for 47 of the events. The mean age of the 52 patients with stent migration was 50 years (range, 19-88 years) and 30 were men (57.6%). The stents for most of the reported cases were ≤60 mm in length (38 of 46; 82.6%). Only three of the reports were of stents >14 mm in diameter (3 of 47; 3.6%). None of the studies had reported migration of stents >100 mm long. In 85% of the migrated stent events, retrieval was attempted, with 65.2% via an endovascular approach. The immediate outcome was satisfactory for 100% of the reported attempts, whether by an endovascular or open surgical approach. CONCLUSIONS: The findings from our literature review suggest that the risk of migration is rare but might be underreported. Most of reported cases had occurred with shorter and smaller diameter stents. The paucity of reported data and the short-term follow-up provided suggest that more formal data collection would provide a truer reflection of the incidence. However, clear strategies to avoid migration should be followed to prevent this complication from occurring.


Assuntos
Remoção de Dispositivo , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/instrumentação , Migração de Corpo Estranho/epidemiologia , Migração de Corpo Estranho/terapia , Stents , Veias , Adulto , Idoso , Idoso de 80 Anos ou mais , Remoção de Dispositivo/efeitos adversos , Feminino , Migração de Corpo Estranho/diagnóstico por imagem , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Medição de Risco , Fatores de Risco , Resultado do Tratamento , Veias/diagnóstico por imagem , Adulto Jovem
4.
Gastroenterol Hepatol ; 45(3): 198-203, 2022 Mar.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-34052404

RESUMO

INTRODUCTION: The use of esophageal stents for the endoscopic management of esophageal leaks and perforations has become a usual procedure. One of its limitations is its high migration rate. To solve this incovenience, the double-layered covered esophageal stents have become an option. OBJECTIVES: To analyse our daily practice according to the usage of double-layered covered esophageal metal stents (DLCEMS) (Niti S™ DOUBLE™ Esophageal Metal Stent Model) among patients diagnosed of esophageal leak or perforation. METHODS: Retrospective, descriptive and unicentric study, with inclusion of patients diagnosed of esophageal leak or perforation, from November 2010 until October 2018. The main aim is to evaluate the efficacy of DLCEMS, in terms of primary success and technical success. The secondary aim is to evaluate their (the DLCEMS) safety profile. RESULTS: Thirty-one patients were firstly included. Among those, 8 were excluded due to mortality not related to the procedure. Following stent placement, technical success was reached in 100% of the cases, and primary success, in 75% (n=17). Among the complications, stent migration was present in 21.7% of the patients (n=5), in whom the incident was solved by endoscopic means. CONCLUSIONS: According to our findings, DLCEMS represent an alternative for esophageal leak and perforation management, with a high success rate in leak and perforation resolutions and low complication rate, in contrast to the published data. The whole number of migrations were corrected by endoscopic replacement, without the need of a new stent or surgery.


Assuntos
Fístula Esofágica/terapia , Perfuração Esofágica/terapia , Complicações Pós-Operatórias/terapia , Desenho de Prótese , Stents Metálicos Autoexpansíveis , Adulto , Idoso , Idoso de 80 Anos ou mais , Fístula Anastomótica/terapia , Feminino , Migração de Corpo Estranho/epidemiologia , Migração de Corpo Estranho/prevenção & controle , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Stents Metálicos Autoexpansíveis/efeitos adversos , Resultado do Tratamento , Adulto Jovem
5.
Bone Joint J ; 104-B(1): 76-82, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-34969283

RESUMO

AIMS: Stemless humeral implants have been developed to overcome stem-related complications in total shoulder arthroplasty (TSA). However, stemless implant designs may hypothetically result in less stable initial fixation, potentially affecting long-term survival. The aim of this study is to investigate early fixation and migration patterns of the stemless humeral component of the Simpliciti Shoulder System and to evaluate clinical outcomes. METHODS: In this prospective cohort study, radiostereometric analysis (RSA) radiographs were obtained in 24 patients at one day, six weeks, six months, one year, and two years postoperatively. Migration was calculated using model-based RSA. Clinical outcomes were evaluated using the visual analogue scale (VAS), the Oxford Shoulder Score (OSS), the Constant-Murley Score (CMS), and the Disabilities of the Arm, Shoulder and Hand (DASH) score. RESULTS: At two years, median translation along the x-, y-, and z-axis was -0.12 mm (interquartile range (IQR) -0.18 to 0.02), -0.17 mm (IQR -0.27 to -0.09), and 0.09 mm (IQR 0.02 to 0.31). Median rotation around the x-, y-, and z-axis was 0.12° (IQR -0.50 to 0.57), -0.98° (IQR -1.83 to 1.23), and 0.09° (IQR -0.76 to 0.30). Overall, 20 prostheses stabilized within 12 months postoperatively. Four prostheses showed continuous migration between 12 and 24 months. At two-year follow-up, with the exception of one revised prosthesis, all clinical scores improved significantly (median VAS difference at rest: -3.0 (IQR -1.5 to -6.0); OSS 22.0 (IQR 15.0 to 25.0); CMS 29.5 (IQR 15.0 to 35.75); and DASH -30.0 (IQR -20.6 to -41.67) (all p < 0.001)) with the exception of one revised prosthesis. CONCLUSION: In conclusion, we found that 20 out of 24 implants stabilized within 12 months postoperatively. The significance of continuous migration in four implants is unclear and future research on the predictive value of early migration for future loosening in TSA is required. Clinical results revealed a clinically relevant improvement. Cite this article: Bone Joint J 2022;104-B(1):76-82.


Assuntos
Artroplastia do Ombro/métodos , Úmero/cirurgia , Prótese de Ombro , Idoso , Idoso de 80 Anos ou mais , Avaliação da Deficiência , Feminino , Seguimentos , Migração de Corpo Estranho/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Países Baixos , Complicações Pós-Operatórias/epidemiologia , Estudos Prospectivos , Análise Radioestereométrica
6.
Ann R Coll Surg Engl ; 103(10): 734-737, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-34719960

RESUMO

INTRODUCTION: Insertion of foreign objects into the rectum is a well-described phenomenon and not an uncommon referral to the general surgeon on call. Although usually not life-threatening, there can be consequences following migration of the object or perforation of the large bowel. This study looks at the incidence of removal of foreign objects from the rectum over the last decade and the financial burden it presents to the NHS. METHODS: Hospital Episode Statistics for 2010-2019 were used to calculate the number of rectal foreign bodies that required removal in hospital. Data for age groups and genders have been compared. RESULTS: A total of 3,500 rectal foreign bodies were removed over the course of 9 years. Males accounted for 85.1% of rectal foreign bodies whilst 14.9% were females. This equates to 348 bed-days per annum. Admission peaks were observed in the second and fifth decades of life. CONCLUSION: This study shows that the incidence of rectal foreign bodies is higher in men and has been increasing over the period studied. Most foreign bodies can be removed trans-anally with the use of anaesthesia, with only a small proportion of patients requiring hospital stay over 24 hours (mean length of stay = 24 hours). Nearly 400 rectal foreign body removals are performed each year with an annual cost of £338,819, illustrating the effect this has on NHS resources.


Assuntos
Corpos Estranhos/cirurgia , Custos de Cuidados de Saúde/estatística & dados numéricos , Reto , Medicina Estatal/economia , Adolescente , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Feminino , Corpos Estranhos/economia , Corpos Estranhos/epidemiologia , Migração de Corpo Estranho/economia , Migração de Corpo Estranho/epidemiologia , Migração de Corpo Estranho/cirurgia , Humanos , Lactente , Tempo de Internação/economia , Tempo de Internação/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Reto/cirurgia , Fatores Sexuais , Medicina Estatal/estatística & dados numéricos , Reino Unido/epidemiologia , Adulto Jovem
7.
Plast Reconstr Surg ; 148(2): 236e-242e, 2021 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-34398090

RESUMO

BACKGROUND: Tissue expansion in the pediatric population can be complicated by high rates of infection and extrusion. The aim of this study was to examine the impact of postoperative antibiotic prophylaxis on infectious complications. METHODS: A retrospective study of all pediatric patients who underwent tissue expander insertion at a children's hospital over a 12-year period was performed. Predictor variables included age, sex, race, indication, anatomical location, number of expanders inserted, serial expansion, history of infection or extrusion, and postoperative antibiotics. Outcome variables included infection and extrusion. Bivariate and multivariate analyses were performed to identify factors associated with infection and/or extrusion. RESULTS: A total of 180 patients who underwent 317 operations for tissue expander insertion were included in this study. Postoperative infection and/or extrusion occurred after 73 operations (23 percent). Postoperative prophylactic antibiotics were prescribed after 232 operations (75 percent), and only perioperative (≤24 hours) antibiotics were administered in 85 cases (25 percent). There were no significant differences in the rate of infection (12.1 percent versus 8.9 percent; p = 0.46), extrusion (16.8 percent versus 17.7 percent; p = 0.88), or infection and/or extrusion (23.7 percent versus 24.1 percent; p = 0.95) between these two groups. Multivariate analysis revealed that postoperative antibiotics did not have a significant association with infection and/or extrusion (OR, 0.84; 95 percent CI, 0.44 to 1.63; p = 0.61). CONCLUSIONS: The rates of infection/extrusion were similar between pediatric patients who received only perioperative antibiotics (≤24 hours) and those who were prescribed a course of postoperative antibiotics. Based on these results, a course of postoperative prophylactic antibiotics may be unnecessary after insertion of tissue expanders in pediatric patients. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.


Assuntos
Antibioticoprofilaxia/estatística & dados numéricos , Migração de Corpo Estranho/epidemiologia , Infecção da Ferida Cirúrgica/epidemiologia , Dispositivos para Expansão de Tecidos/efeitos adversos , Expansão de Tecido/efeitos adversos , Adolescente , Antibacterianos/uso terapêutico , Criança , Pré-Escolar , Migração de Corpo Estranho/etiologia , Migração de Corpo Estranho/prevenção & controle , Hospitais Pediátricos/estatística & dados numéricos , Humanos , Lactente , Recém-Nascido , Masculino , Cuidados Pós-Operatórios/estatística & dados numéricos , Cuidados Pré-Operatórios/estatística & dados numéricos , Estudos Retrospectivos , Infecção da Ferida Cirúrgica/prevenção & controle , Expansão de Tecido/instrumentação , Resultado do Tratamento
8.
Surg Laparosc Endosc Percutan Tech ; 31(6): 697-702, 2021 Jun 23.
Artigo em Inglês | MEDLINE | ID: mdl-34166326

RESUMO

AIM: The aim of this study was to investigate the incidence, risk factors, and treatment strategies of proximally migrated pancreatic stents. MATERIALS AND METHODS: The data of 626 sessions of 421 patients with pancreatic duct stenting were retrospectively analyzed between 2010 and 2018, and patients with proximally migrated stents were included in the study. RESULTS: Of 626 stents examined, 77 migrated proximally (12%). The migration rate (MR) was 16%, 2%, and 7%, respectively, in patients treated with chronic pancreatitis, malignancy, and pancreatic leakage indication. The MR was 14% in procedures with pancreatic duct stenosis, 21% in procedures with pancreatic sphincterotomy, and 27% in procedures performed from minor papillae. The MR of the 5, 7, and 10 Fr stents was 4%, 17%, and 10%, respectively. Of the 77 migrated stents, 64 were successfully removed (83%). This success rate (SR) was 84% in procedures with chronic pancreatitis indication, 83% in procedures with pancreatic duct stenosis, 79% in procedures with sphincterotomy, and 75% in procedures performed from minor papillae. The SR of the 5, 7, and 10 Fr stents was 100%, 79%, and 92%, respectively. It was also determined that 33 stents were fractured and migrated (43%). The SR of the fractured stents was 76%. Moreover, of the stents that were successfully removed, 35 were removed with forceps (55%) and 15 (23%) were removed with a balloon. Furthermore, in 47 cases, the stent was removed in the first session (73%). Acute pancreatitis occurred in 5 patients (8%) and perforation occurred in 1 patient (2%). CONCLUSION: In this study, it was shown that proximal migration of pancreatic stents is frequent and most of these stents can be removed successfully.


Assuntos
Migração de Corpo Estranho , Pancreatite , Doença Aguda , Colangiopancreatografia Retrógrada Endoscópica , Migração de Corpo Estranho/epidemiologia , Migração de Corpo Estranho/etiologia , Migração de Corpo Estranho/cirurgia , Humanos , Incidência , Estudos Retrospectivos , Fatores de Risco , Stents
9.
Eur J Vasc Endovasc Surg ; 62(1): 26-35, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-34090782

RESUMO

OBJECTIVE: Aortic neck dilatation (AND) occurs after endovascular aneurysm repair (EVAR) with self expanding stent grafts (SESs). Whether it continues, ultimately exceeding the endograft diameter leading to abdominal aortic aneurysm (AAA) rupture, remains uncertain. Dynamics, risk factors, and clinical relevance of AND were investigated after EVAR with standard SESs. METHODS: All intact EVAR patients treated from 2000 to 2015 at a tertiary institution were included. Demographic, anatomical, and device related characteristics were investigated as risk factors for AND. Outer to outer diameters were measured at a single standardised aortic level on reconstructed computed tomography (CT) images. RESULTS: A total of 460 patients were included (median follow up 5.2 years, interquartile range [IQR] 3.0, 7.7 years; CT imaging follow up 3.3 years, IQR 1.3, 5.4). Baseline neck diameter was 24 mm (IQR 22, 26) and increased 11.1% (IQR 1.5%, 21.9%) at last CT imaging. Endograft oversizing was 20.0% (IQR 13.6, 28.0). AND was greater during the first year (5.2% [IQR 0, 11.7]) decreasing subsequently (two to four years to 1.4%/year [IQR 0.0, 4.5%], p ≤ .001) and was associated with suprarenal fixation endografts (t value = 7.9, p < .001) and oversizing (t value = 4.4, p < .001). AND exceeding the endograft was 3.5% (95% CI 2.2% - 4.8%) and 14.4% (95% CI 11.0% - 17.8%) at five and eight years, respectively. Excessive AND was associated with baseline neck diameter (OR 1.2/mm, 95% CI 1.05 - 1.41) while the Excluder endograft had a protective effect (OR 0.15, 95% CI 0.04 - 0.58). Excessive AND was associated with type 1A endoleak (HR 3.3, 95% CI 1.1 - 9.7) and endograft migration > 5 mm (HR 3.1, 95% CI 1.4 - 6.9). CONCLUSION: AND after EVAR with SES is associated with endograft oversizing and radial force but decelerates after the first post-operative year. Baseline aortic neck diameter and suprarenal stent bearing endografts were associated with an increased risk of AND beyond nominal stent graft diameter. However, it remains unclear whether patient selection, differences in endograft radial force or the suprarenal stent are accountable for this difference.


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Ruptura Aórtica/epidemiologia , Dilatação Patológica/epidemiologia , Endoleak/epidemiologia , Procedimentos Endovasculares/efeitos adversos , Migração de Corpo Estranho/epidemiologia , Idoso , Aorta Abdominal/diagnóstico por imagem , Aorta Abdominal/cirurgia , Aneurisma da Aorta Abdominal/complicações , Ruptura Aórtica/etiologia , Aortografia , Angiografia por Tomografia Computadorizada , Dilatação Patológica/diagnóstico , Dilatação Patológica/etiologia , Endoleak/diagnóstico , Endoleak/etiologia , Procedimentos Endovasculares/instrumentação , Feminino , Migração de Corpo Estranho/etiologia , Humanos , Masculino , Pescoço , Estudos Retrospectivos , Fatores de Risco , Stents/efeitos adversos , Resultado do Tratamento
10.
Bone Joint J ; 103-B(4): 644-649, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33789489

RESUMO

AIMS: The aim of this prospective cohort study was to evaluate the early migration of the TriFit cementless proximally coated tapered femoral stem using radiostereometric analysis (RSA). METHODS: A total of 21 patients (eight men and 13 women) undergoing primary total hip arthroplasty (THA) for osteoarthritis of the hip were recruited in this study and followed up for two years. Two patients were lost to follow-up. All patients received a TriFit stem and Trinity Cup with a vitamin E-infused highly cross-linked ultra-high molecular weight polyethylene liner. Radiographs for RSA were taken postoperatively and then at three, 12, and 24 months. Oxford Hip Score (OHS), EuroQol five-dimension questionnaire (EQ-5D), and adverse events were reported. RESULTS: At two years, the mean subsidence of the head and tip for the TriFit stem was 0.38 mm (SD 0.32) and 0.52 mm (SD 0.36), respectively. The total migration of the head and tip was 0.55 mm (SD 0.32) and 0.71 mm (SD 0.38), respectively. There were no statistically significant differences between the three to 12 months' migration (p = 0.105) and 12 to 24 months' migration (p = 0.694). The OHS and EQ-5D showed significant improvements at two years. CONCLUSION: The results of this study suggest that the TriFit femoral stem achieves initial stability and is likely to be stable in the mid and long term. A long-term outcome study is required to assess late mechanisms of failure and the effects of bone mineral density (BMD) related changes. Cite this article: Bone Joint J 2021;103-B(4):644-649.


Assuntos
Artroplastia de Quadril , Migração de Corpo Estranho/epidemiologia , Prótese de Quadril , Osteoartrite do Quadril/cirurgia , Desenho de Prótese , Idoso , Idoso de 80 Anos ou mais , Materiais Revestidos Biocompatíveis , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Falha de Prótese
11.
Heart Rhythm ; 18(1): 41-49, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-32798776

RESUMO

BACKGROUND: Pacing leads are the Achilles heel of pacemakers. Most manufacturers report a 3-year survival rate of >99% of their leads. We observed several failures of the Beflex/Vega leads (MicroPort, Shanghai, China; formerly Sorin/LivaNova). OBJECTIVE: The purpose of this study was to investigate failure rates of Beflex/Vega leads. METHODS: We analyzed the performance of Beflex/Vega leads implanted at our tertiary referral center. All-cause lead failures (any issues requiring reinterventions such as lead dislocations, cardiac perforations, and electrical abnormalities) were identified during follow-up. The Beflex/Vega lead was compared with a reference lead (CapSureFix Novus 5076, Medtronic, Minneapolis, MN) implanted within the same period and by the same operators. RESULTS: A total of 585 leads were analyzed (382 Beflex/Vega and 203 CapSureFix Novus 5076 leads). Cumulative failure rate estimates were 5.2%, 6.3%, and 12.4% after 1, 2, and 3 years for the Beflex/Vega lead. This was worse compared to the reference lead (1.5%, 1.5%, 3.7% after 1, 2, and 3 years; P = .001). Early failure manifestations up to 3 months occurred at a similar rate (Beflex/Vega vs CapSureFix Novus 5076 lead: 1.3% vs 0.5% for dislocations; 1.3% vs 1.0% for perforations). During follow-up, electrical abnormalities such as noise oversensing (P = .013) and increased pacing thresholds (P = .003) became more frequent in the Beflex/Vega group. Electrical abnormalities were the most common failure manifestation 3 years after implantation in this group (9.4% vs 2.2% for the CapSureFix Novus 5076). CONCLUSION: The failure rate of the Beflex/Vega lead of >10% after 3 years was higher than that of a competitor lead. This gives rise to concern since >135,000 such leads are active worldwide.


Assuntos
Eletrodos Implantados/efeitos adversos , Falha de Equipamento/estatística & dados numéricos , Migração de Corpo Estranho/complicações , Traumatismos Cardíacos/epidemiologia , Marca-Passo Artificial/efeitos adversos , Sistema de Registros , Idoso , Idoso de 80 Anos ou mais , Desenho de Equipamento , Feminino , Seguimentos , Migração de Corpo Estranho/epidemiologia , Traumatismos Cardíacos/etiologia , Humanos , Incidência , Masculino , Estudos Retrospectivos , Suíça/epidemiologia
12.
Eur J Vasc Endovasc Surg ; 61(2): 211-218, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-33303312

RESUMO

OBJECTIVE: High rates of midterm failure of the Nellix EndoVascular Aneurysm Sealing (EVAS) System resulted in device withdrawal from the UK market. The study aim was to report long term Nellix EVAS outcomes and management of a failing device. METHODS: A retrospective review of EVAS procedures at a tertiary unit was performed. Device failure was defined as a triad of stent migration, stent separation, and secondary sac expansion, or any intervention for type 1 endoleak, device rupture, or explant. RESULTS: 161 (male n = 140, female n = 21) patients with a median follow up of 6.0 (IQR 5.0-6.6) years were included. Freedom from all cause mortality estimate at six years was 41.5%. There were 70 (43.5%) device failures with a freedom from device failure estimate at six years of 32.3%. Failure was the result of sac expansion (n = 41), caudal stent migration (n = 36), stent separation (n = 26), and secondary AAA rupture (n = 15). A substantial number of type 1 endoleaks was present (1a n = 33, 1b n = 11), but the type 2 endoleak rate was low at 3.7%. Some 36 (22.4%) patients required re-intervention. Twenty-one patients underwent explant with no 30 day deaths. Six patients underwent Nellix-in-Nellix application (NINA) with one early death from bowel ischaemia and one patient who died later from non-aneurysm related cause. Two NINA patients have ongoing sac expansion and two have had thrombosis of a Nellix limb or visceral stent. Proximal embolisation was only successful in one of six cases. CONCLUSION: The long term failure rate of Nellix EVAS is high. All patients with a device must be informed and be enrolled in enhanced surveillance. EVAS explant is an acceptable technique with favourable outcomes. Management by open explant, if the patient is fit, should be considered early and offered to those with device failure.


Assuntos
Implante de Prótese Vascular/instrumentação , Prótese Vascular , Procedimentos Endovasculares/instrumentação , Falha de Prótese , Stents , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Migração de Corpo Estranho/diagnóstico , Migração de Corpo Estranho/epidemiologia , Migração de Corpo Estranho/terapia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos
13.
J Vasc Interv Radiol ; 31(12): 2073-2080, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33189540

RESUMO

PURPOSE: To examine spinal interaction types and prevalence of inferior vena cava (IVC) filters in patients presenting for complex filter removal. MATERIALS AND METHODS: The records of 447 patients presenting for complex removal of IVC filters were reviewed, including patient demographics, IVC filter dwell time, filter fracture status, and computed tomography (CT) evidence of filter interaction with the spine. Spinal interaction was defined as a filter strut touching or penetrating into the vertebral body or disc. Patients with evidence of filter penetration and spinal interaction had abdominal CT that preceded filter removal assessed by 2 interventional radiologists to categorize the type of spinal interaction, including bony reaction and osteophyte formation. RESULTS: CT evidence of spinal interaction by the filter was found in 18% of patients (80/447). Interaction with the spine was more common in single point of fixation filters than filters with rails (P = .007) and was more likely in filters with round wires than flat wires (P = .0007). Patients with interaction had longer dwell times (mean [SD] 5.7 [4.46] y) compared with patients without interaction (mean [SD] 3.2 [3.85] y); this relationship was significant (P < .0001). Women were more likely than men to experience filter/spine interaction (P = .04). Filters with spinal interaction were more likely to be fractured (P = .001). Filter interaction was found in 38% (30/78) of patients with symptoms, including chest and back pain, compared with 14% (50/369) of patients without symptoms (P < .0001, odds ratio 3.99). CONCLUSIONS: Retrievable IVC filters may interact with the spine. These interactions are associated with longer filter dwell times, female sex, and round wire filter construction.


Assuntos
Remoção de Dispositivo , Migração de Corpo Estranho/cirurgia , Disco Intervertebral , Falha de Prótese , Filtros de Veia Cava , Veia Cava Inferior , Corpo Vertebral , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Remoção de Dispositivo/efeitos adversos , Feminino , Migração de Corpo Estranho/diagnóstico por imagem , Migração de Corpo Estranho/epidemiologia , Humanos , Disco Intervertebral/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Philadelphia/epidemiologia , Prevalência , Desenho de Prótese , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Veia Cava Inferior/diagnóstico por imagem , Corpo Vertebral/diagnóstico por imagem , Adulto Jovem
14.
Bone Joint J ; 102-B(9): 1158-1166, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32862688

RESUMO

AIMS: The primary objective of this study was to compare migration of the cemented ATTUNE fixed bearing cruciate retaining tibial component with the cemented Press-Fit Condylar (PFC)-sigma fixed bearing cruciate retaining tibial component. The secondary objectives included comparing clinical and radiological outcomes and Patient Reported Outcome Measures (PROMs). METHODS: A single blinded randomized, non-inferiority study was conducted including 74 patients. Radiostereometry examinations were made after weight bearing, but before hospital discharge, and at three, six, 12, and 24 months postoperatively. PROMS were collected preoperatively and at three, six, 12, and 24 months postoperatively. Radiographs for measuring radiolucencies were collected at two weeks and two years postoperatively. RESULTS: The overall migration (mean maximum total point motion (MPTM)) at two years was comparable: mean 1.13 mm (95% confidence interval (CI), 0.97 to 1.30) for the ATTUNE and 1.16 mm (95% CI, 0.99 to 1.35) for the PFC-sigma. At two years, the mean backward tilting was -0.43° (95% CI, -0.65 to -0.21) for the ATTUNE and 0.08° (95% CI -0.16 to 0.31), for the PFC-sigma. Overall migration between the first and second postoperative year was negligible for both components. The clinical outcomes and PROMs improved compared with preoperative scores and were not different between groups. Radiolucencies at the implant-cement interface were mainly seen below the medial baseplate: 17% in the ATTUNE and 3% in the PFC-sigma at two weeks, and at two years 42% and 9% respectively (p = 0.001). CONCLUSION: In the first two postoperative years the initial version of the ATTUNE tibial component was not inferior with respect to overall migration, although it showed relatively more backwards tilting and radiolucent lines at the implant-cement interface than the PFC-sigma. The version of the ATTUNE tibial component examined in this study has subsequently undergone modification by the manufacturer. Level of Evidence: 1 (randomized controlled clinical trial) Cite this article: Bone Joint J 2020;102-B(9):1158-1166.


Assuntos
Artroplastia do Joelho/métodos , Cimentos Ósseos , Migração de Corpo Estranho/epidemiologia , Prótese do Joelho/efeitos adversos , Idoso , Feminino , Migração de Corpo Estranho/diagnóstico por imagem , Humanos , Masculino , Pessoa de Meia-Idade , Medidas de Resultados Relatados pelo Paciente , Desenho de Prótese , Falha de Prótese , Análise Radioestereométrica , Método Simples-Cego , Tíbia , Resultado do Tratamento
15.
Clin Neurol Neurosurg ; 194: 105819, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32259672

RESUMO

OBJECTIVE: Facial pain refractory to medical treatments may benefit from neurosurgical interventions. Only a few studies have reported on the efficacy of peripheral trigeminal stimulation and more specifically supraorbital nerve (SON) and infraorbital nerve (ION) stimulation for the treatment of facial pain. PATIENTS AND METHODS: In the present study, we identified all patients at our institution who underwent SON and/or ION stimulation for treatment of facial pain due to post-herpetic, traumatic or idiopathic etiology. Relevant pre and post-operative outcomes were analyzed. RESULTS: We identified 15 patients who underwent SON and/or ION stimulation. Among them, 12 (80 %) endorsed >50 % pain relief during the trial stimulation period. After a median follow-up of 5.8 months with permanent implantation, 1 patient (8.3 %) was diagnosed with lead erosion and IPG migration, two patients had lead infections (16.7 %) and one (8.3 %) had wound dehiscence. No lead migrations were identified during the long-term follow-up. The VAS score showed a statistically significant reduction from a median pre-operative score of 7 to a post-operative score of 1.8 (p = 0.011), which corresponded to a 74.3 % average pain reduction. CONCLUSION: SON and/or ION stimulation can be an effective treatment for intractable facial pain due to post-herpetic, traumatic or idiopathic etiology; however the complication rate is relatively high. Future prospective studies with longer follow-up periods are warranted.


Assuntos
Terapia por Estimulação Elétrica/métodos , Dor Facial/cirurgia , Dor Facial/terapia , Nervo Trigêmeo , Adulto , Idoso , Idoso de 80 Anos ou mais , Terapia por Estimulação Elétrica/efeitos adversos , Eletrodos Implantados/efeitos adversos , Traumatismos do Nervo Facial/complicações , Traumatismos do Nervo Facial/terapia , Feminino , Seguimentos , Migração de Corpo Estranho/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Neuralgia Pós-Herpética/terapia , Procedimentos Neurocirúrgicos/métodos , Medição da Dor , Dor Intratável , Nervos Periféricos , Complicações Pós-Operatórias/epidemiologia , Estudos Retrospectivos , Resultado do Tratamento
16.
Scand J Gastroenterol ; 55(4): 485-491, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32202441

RESUMO

Introduction: Percutaneous Endoscopic Gastrostomy (PEG) is accepted as an efficient method to provide long-term enteral nutrition. PEG accidental dislodgement (device exteriorization confirmed by expert evaluation) rate is high and can lead to major morbidity.Objective: To identify independent risk factors for PEG accidental dislodgement.Methods: Retrospective, single-center study, including consecutive patients submitted to PEG procedure, for 38 consecutive months. Every patient had 12 months minimum follow-up after PEG placement. Univariate analysis selected variables with at least marginal association (p < .15) with the outcome variable, PEG dislodgement, which were included in a logistic regression multivariate model. Discriminative power was assessed using area under curve (AUC) of the receiver operating curve (ROC).Results: We included 164 patients, 67.7% (111) were female, mean age was 81 years. We report 59 (36%) PEG dislodgements, of which 13 (7.9%) corresponded to early dislodgements. The variables with marginal association were hypoalbuminemia (p = .095); living at home (p = .049); living in a nursing home (p = .074); cerebrovascular disease (CVD) (p = .028); weight change of more than 5 kg, either increase or decrease (p = .001); psychomotor agitation (p < .001); distance inner bumper-abdominal wall (p = .034) and irregular appointment follow-up (p = .149). At logistic multivariate regression, the significant variables after model adjustment were CVD OR 4.8 (CI 95% 2.0-11.8), weight change OR 4.7 (CI 95%1.6-13.9) and psychomotor agitation OR 18.5 (CI 95% 5.2-65.6), with excellent discriminative power (AUC ROC 0.797 [CI95% 0.719-0.875]).Conclusion: PEG is a common procedure and accidental dislodgement is a frequent complication. CVD, psychomotor agitation and weight change >5 kg increase the risk of this complication and should be seriously considered when establishing patients' individual care requirements.


Assuntos
Migração de Corpo Estranho/etiologia , Gastrostomia/efeitos adversos , Gastrostomia/mortalidade , Idoso , Idoso de 80 Anos ou mais , Transtornos Cerebrovasculares/complicações , Nutrição Enteral/efeitos adversos , Nutrição Enteral/instrumentação , Nutrição Enteral/métodos , Nutrição Enteral/mortalidade , Falha de Equipamento , Feminino , Migração de Corpo Estranho/epidemiologia , Gastroscopia/efeitos adversos , Gastroscopia/métodos , Gastroscopia/mortalidade , Gastrostomia/instrumentação , Gastrostomia/métodos , Humanos , Modelos Logísticos , Masculino , Análise Multivariada , Agitação Psicomotora/complicações , Curva ROC , Estudos Retrospectivos , Fatores de Risco , Aumento de Peso/fisiologia , Redução de Peso/fisiologia
17.
Retina ; 40(5): 825-832, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-30789460

RESUMO

PURPOSE: To establish the prevalence and risk factors for intravitreal dexamethasone implant migration into the anterior chamber in eyes with macular edema. METHODS: This was a multicenter, retrospective, observational chart review of data that included patients with macular edema who had been treated with at least one intravitreal dexamethasone injection. Patients with incomplete chart information during the follow-up period were excluded. RESULTS: The prevalence of implant migration in 468 patients, considering the number of injections, was 1.6%, with significant associations between implant migration and cataract surgery (P = 0.043) and intraocular lens status (P = 0.005) and a trend toward statistical significance (P = 0.057) with vitrectomy. A higher rate of implant migration into the anterior chamber was observed in vitrectomized eyes (4.8%) when compared with patients who did not undergo a vitrectomy (1.6%). The implants that migrated were removed with forceps with/without viscoelastic expression or with 20-gauge cannulas connected to the vitreous cutter machine. CONCLUSION: The risk of implant migration into the anterior chamber was 1.6%. Risk factors were a history of cataract surgery or vitrectomy and aphakia. When anterior migration occurs, rapid removal is advised, especially if corneal edema is present.


Assuntos
Câmara Anterior , Dexametasona/administração & dosagem , Implantes de Medicamento/efeitos adversos , Migração de Corpo Estranho/diagnóstico , Acuidade Visual , Idoso , Feminino , Migração de Corpo Estranho/epidemiologia , Glucocorticoides/administração & dosagem , Humanos , Incidência , Injeções Intravítreas , Edema Macular/diagnóstico , Edema Macular/tratamento farmacológico , Masculino , Estudos Retrospectivos , Estados Unidos/epidemiologia
18.
Ann Vasc Surg ; 62: 474-483, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31449934

RESUMO

BACKGROUND: Complications after thoracic endovascular aortic repair (TEVAR) are common. Even after a successful TEVAR, a late endoleak (>30 days) can occur. The objective of this study is to summarize the current evidence and, if lacking, the need of evidence regarding the incidence and predictive factors for type 1b endoleak in patients with aortic aneurysm treated with TEVAR. METHODS: A systematic review of the literature was performed on endoleak type 1b, in patients with aortic aneurysm, after TEVAR. The PubMed and Embase databases were systematically searched for articles regarding endoleak type 1b up to January 2019. The main subjects discussed are the incidence, risk factors, treatment, and prognosis. RESULTS: About 722 articles were screened, and 16 articles were included in this review. The reported incidence of endoleak is between 1.0% and 15.0%, with a mean follow-up duration of at least 1 year. Type 1b endoleak is associated with an increased aortic tortuosity index (>0.15 cm-1). No significant difference is found in relation to age and gender. Treatment is required in most cases (22/27) and is usually performed with distal extension of the stent graft (21/27). There are no data regarding stent graft oversizing, length of distal landing zone, and differences between devices or the prognosis for patients with type 1b endoleak. CONCLUSIONS: Limited literature is available on the occurrence of type 1b endoleak after TEVAR. A tortuous aorta can be associated as a predictive factor for the occurrence of type 1b endoleak. Data clearly delineating the anatomic variables predicting type 1b endoleak should be examined and listed. Likewise, the impact of more recent conformable devices to prevent complications like type 1b endoleaks from occurring should be elucidated.


Assuntos
Aorta Torácica/cirurgia , Aneurisma da Aorta Torácica/cirurgia , Implante de Prótese Vascular/efeitos adversos , Prótese Vascular/efeitos adversos , Endoleak/epidemiologia , Procedimentos Endovasculares/efeitos adversos , Migração de Corpo Estranho/epidemiologia , Stents/efeitos adversos , Aorta Torácica/diagnóstico por imagem , Aneurisma da Aorta Torácica/diagnóstico por imagem , Aneurisma da Aorta Torácica/epidemiologia , Implante de Prótese Vascular/instrumentação , Endoleak/diagnóstico por imagem , Procedimentos Endovasculares/instrumentação , Feminino , Migração de Corpo Estranho/diagnóstico por imagem , Humanos , Incidência , Masculino , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
19.
J Vasc Surg ; 71(2): 457-469.e1, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31405762

RESUMO

BACKGROUND: Endovascular aneurysm sealing (EVAS) is a disruptive technology to treat abdominal aortic aneurysm (AAA). The use of sac filling rather than endograft fixation was designed to treat aortic aneurysms in a wide range of morphologic appearances and to reduce endoleaks. There are few data reporting outcomes beyond postoperative follow-up. This study reports outcomes up to 5 years for Nellix (Endologix, Irvine, Calif) EVAS. METHODS: Data were prospectively collected for EVAS patients from the time of adoption of EVAS in 2013. All patients treated with the Nellix device are included in this study, and as such, it reports on infrarenal, ruptured, and iliac aneurysms as well as the Nellix-in-Nellix application. Juxtarenal and suprarenal aneurysms were treated using the EVAS system with parallel grafts into the visceral vessels and are included. Therapeutic failure, a composite outcome of migration, sac expansion >5 mm, type Ia and type Ib endoleak, and secondary aortic rupture, was the primary outcome along with all-cause mortality, aneurysm-related mortality, and reintervention rates. RESULTS: There were 295 EVAS cases undertaken between March 2013 and July 2018. Indications for treatment were infrarenal (n = 185), juxtarenal and suprarenal (n = 73), ruptured (n = 18), and iliac (n = 13) aneurysms. There were 15 reinterventions using the Nellix-in-Nellix application. In some cases, EVAS was used to salvage failing endovascular or open aneurysm repairs. Median follow-up was 2.42 years (interquartile range, 1.07-3.57 years). Therapeutic failure was observed in 98 of the 295 cases (33.2%) overall and exceeded 50% in some subgroups. In 71 cases (24.1%), reintervention was performed, with reasons for no reintervention being mainly physiologic. Complications leading to therapeutic failure were most commonly seen beyond 2 years of follow-up. There were 15 secondary ruptures (5.36%), and 9 EVAS devices required explantation either electively or for aortic rupture. CONCLUSIONS: EVAS with the Nellix device has not met expectations, and early encouraging results have been eroded. The incidence of therapeutic failure has been high, occurring 2 years and beyond after implantation. The Nellix system has been voluntarily recalled by Endologix, and the CE mark has subsequently been suspended. The adoption of EVAS as a disruptive technology highlights the need for cautious adoption of novel technologies and the strict governance around such arrangements.


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Procedimentos Endovasculares/instrumentação , Migração de Corpo Estranho/epidemiologia , Complicações Pós-Operatórias/epidemiologia , Falha de Tratamento , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Tempo
20.
J Neurointerv Surg ; 12(5): 505-511, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-31662464

RESUMO

BACKGROUND: Coil migration is a complication of endovascular coiling of cerebral aneurysms that has not been well studied. OBJECTIVE: To report the frequency, risk factors, management strategies, and outcomes of coil migration. METHODS: This was a retrospective analysis of the clinical and radiological data of patients who underwent cerebral aneurysm coiling complicated by coil migration at five neuroendovascular centers in the United States, Canada, and France between 2008 and 2018. RESULTS: Eighteen cases of coil migration met our study criteria with an occurrence of 0.3% (18/6071 cases) (procedural migration: 55%, delayed migration: 45%). The mean aneurysm maximal diameter, neck, and height to neck ratio in migration cases were 3.4±1.4 mm (range 2-7.6 mm), 2.4±0.9 mm (range 1.2-4.4 mm), and 1.4±0.4 (range 1-2.15), respectively. The 2 mm diameter coil was the most common (39%, range 1-2.5 mm) migrated coil. The length of the migrated coil was ≤4 cm in 95% of cases.Patients managed conservatively (5/18, 28%) did well. Thromboembolic and/or hemorrhagic complications were noted in 6/10 migration patients treated by endovascular modalities and in all migration patients who underwent surgical treatment (4/4). Three deaths occurred (3/18, 17%) related to high Hunt and Hess grade subarachnoid hemorrhage. CONCLUSION: Coil migration is an uncommon but important complication of cerebral aneurysm coiling. Small aneurysms, aspect ratio <1.6, and small coils are significant risk factors. Endovascular treatment, such as using a stent retriever, can be considered for procedural, proximal migration, and/or in cases of vessel occlusion. Delayed or distal migration should be managed conservatively.


Assuntos
Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/instrumentação , Migração de Corpo Estranho/diagnóstico por imagem , Migração de Corpo Estranho/epidemiologia , Aneurisma Intracraniano/epidemiologia , Aneurisma Intracraniano/terapia , Adulto , Idoso , Canadá/epidemiologia , Angiografia Cerebral/métodos , Feminino , França/epidemiologia , Humanos , Aneurisma Intracraniano/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Estudos Retrospectivos , Stents/efeitos adversos , Resultado do Tratamento , Estados Unidos/epidemiologia
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