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BACKGROUND: Hemodialysis requires reliable, recurrent access to the circulatory system. Central venous tunneled dialysis catheters (TDC) are frequently used for patients receiving hemodialysis as a bridge to permanent vascular access or as a final option. TDC are prone to complications such as infection and dysfunction. OBJECTIVES: To assess the prevalence and predictors of TDC dysfunction in a cohort of chronic hemodialysis patients. METHODS: This single-center, retrospective study was based on data from an electronic database of chronic hemodialysis patients during 5 years of follow-up. RESULTS: A total of 625 TDC were inserted in 361 patients, of which 234 (37.4%) were replaced due to dysfunction. The main insertion site was the right internal jugular vein. Diabetes mellitus was an important predictor of TDC dysfunction and was significantly correlated with TDC extraction. Chronic anticoagulation and antiplatelet treatment did not affect the rate of TDC dysfunction or replacement. CONCLUSIONS: TDC use for chronic dialysis patients is increasing and dysfunction is a major problem. In our study, we highlighted the high prevalence of TDC dysfunction and the need for further research to improve hemodialysis access as well as TDC patency and function.
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Cateterismo Venoso Central , Catéteres de Permanencia , Diálisis Renal , Humanos , Diálisis Renal/métodos , Diálisis Renal/efectos adversos , Estudios Retrospectivos , Masculino , Femenino , Prevalencia , Persona de Mediana Edad , Cateterismo Venoso Central/efectos adversos , Cateterismo Venoso Central/métodos , Catéteres de Permanencia/efectos adversos , Anciano , Venas Yugulares , Catéteres Venosos Centrales/efectos adversos , Falla de Equipo/estadística & datos numéricos , Factores de Riesgo , Fallo Renal Crónico/terapia , Fallo Renal Crónico/epidemiología , Israel/epidemiología , Estudios de SeguimientoRESUMEN
PURPOSE: Aim of this study is to summarize medical device reports (MDRs) between 2012 and 2022 relating to ureteral stents within the Manufacturer and User Facility Device Experience (MAUDE) database maintained by The Food and Drug Administration (FDA). METHODS: MAUDE was analyzed for all MDRs relating to each FDA-approved ureteral stent. Event descriptions were reviewed and characterized into specific event types. Outcome measures include specific ureteral stent and reported events as detailed by the MDRs. Data is presented as number of specific event/total events. Pooled Relative risk was used to compare data. RESULTS: 2652 reports were retrieved in 10 years and a progressive rise in reported events was recorded. 831/2652 (31%) were reported as injury while 1810/2652 (68%) as malfunction of the ureteral stent and 4 events of death. The most frequently reported adverse events (AEs) were stent break (627/2652: 23%); material problems (384/2652: 14%); calcification (222/2652: 8%); difficulty to insert, advance or remove the device (155/2652: 6%). Bard stents were associated with most material problems (19%), Resonance stents were associated with most difficulty to insert, advance or remove the device (9%) and calcification (15%) while filiform double pigtail stent set were associated with most breakage reports (56%) when compared to the other stents (PRR > 1, p < 0,05). CONCLUSIONS: According to MAUDE database the most frequent complications related to ureteral stents are breakage, material problems, calcification and difficulty to insert/advance/remove the device. As well Resonance ureteral stents seem to be associated with a higher risk of device problems.
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Bases de Datos Factuales , Stents , United States Food and Drug Administration , Uréter , Stents/efectos adversos , Humanos , Estados Unidos/epidemiología , Uréter/cirugía , Incidencia , Falla de Prótesis , Falla de Equipo/estadística & datos numéricos , Vigilancia de Productos ComercializadosRESUMEN
OBJECTIVE: To identify adverse events (AEs) related to suction electrocautery use during adenotonsillectomy. METHODS: The US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was searched using the terms "suction cautery," "suction electrocautery," "suction Bovie," and "suction coagulator" from January 2014 to December 2023. RESULTS: 165 AE reports were gathered from the MAUDE database medical device reports (MDRs). 36 met inclusion criteria. Patient injuries were found in 22 (61.1 %) reports and device malfunction events were found in 14 (38.9 %) reports. All patient injuries were thermal burns (N = 22, 100 %). Location of burn injuries included the lip (N = 6, 27.3 %), oral commissure (N = 5, 22.7 %), and tongue (N = 4, 18.2 %). The most common cause of an AE was inadequate device insulation (N = 7, 19.4 %). CONCLUSION: The suction electrocautery apparatus may malfunction and cause patient burn injuries. Device failures mainly result from inadequate device insulation, coagulation problems, and detachment of device components. Surgeons must be aware of these potential complications and counsel parents and patients regarding AEs.
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Adenoidectomía , Bases de Datos Factuales , Electrocoagulación , Falla de Equipo , Tonsilectomía , Tonsilectomía/efectos adversos , Tonsilectomía/instrumentación , Humanos , Electrocoagulación/efectos adversos , Electrocoagulación/instrumentación , Adenoidectomía/efectos adversos , Adenoidectomía/instrumentación , Succión/instrumentación , Succión/efectos adversos , Estados Unidos , Falla de Equipo/estadística & datos numéricos , United States Food and Drug Administration , Quemaduras/etiologíaRESUMEN
Importance: Catheter dislodgement is a common complication for children with tunneled or peripherally inserted noncuffed central venous catheters (CVCs). A subcutaneous anchor securement system (SASS) may reduce this risk compared with traditional adhesive securement. Objective: To compare dislodgement of noncuffed CVCs secured with SASS with dislodgement of noncuffed CVCs secured with sutureless securement devices (SSDs). Design, Setting, and Participants: The SECURED (Securing Central Venous Catheters to Prevent Dislodegment) trial was a pragmatic, multicenter, superiority randomized clinical trial with an internal pilot and was conducted from August 5, 2020, to August 30, 2022, at 2 Australian quaternary pediatric hospitals. Data analysis was performed in January 2023. Patients aged 0 to 18 years requiring a noncuffed CVC (≥3F catheter) were eligible for inclusion. Follow-up duration was 8 weeks or until device removal. Interventions: Patients were randomly assigned 1:1 to receive an SASS or SSD, stratified by hospital and catheter type. Only 1 catheter was studied per patient. Main Outcomes and Measures: The primary outcome was dislodgement (partial or total), defined as movement of the catheter tip by greater than 1 cm (change in external catheter length) at any point during catheter dwell. Dislodgement, reported as a risk ratio (RR), was estimated using a generalized linear model with binomial family and log link. Secondary outcomes were reported as incidence rate ratios and were analyzed using Poission regression. Outcomes reported as mean differences (MDs) were analyzed using linear regression. Results: Of 310 randomized patients, 175 patients (56.5%) were male and median (IQR) patient age was 48 (16-120) months. A total of 307 patients had a catheter device inserted, of which 153 (49.8%) were SASS and 154 (50.2%) were SSD, and were included in the intention-to-treat (ITT) analysis. Device dislodgement was lower with SASS (8 dislodgements in 153 patients [5.2%]) compared with SSD (35 dislodgements in 154 patients [22.7%]) (RR, 0.23; 95% CI, 0.11-0.48; P < .001). The per-protocol analysis was consistent with the ITT analysis. Partial dislodgement accounted for most dislodgement events, including 6 partial dislodgements in the SASS group (3.9%) and 30 partial dislodgements in the SSD group (19.5%) (RR, 0.18; 95% CI, 0.08-0.42). This contributed to fewer complications during dwell in the SASS group (37 reported complications [24.2%]) vs the SSD group (60 reported complications [39.0%]) (RR, 0.62; 95% CI, 0.44-0.87). Staff reported greater difficulty removing devices anchored with SASS vs SSD (mean [SD], 29.1 [31.3] vs 5.3 [17.0], respectively; MD, 23.8; 95% CI, 16.7-31.0). However, use of SASS resulted in reduced per-participant health care costs of A$36.60 (95% credible interval, 4.25-68.95; US $24.36; 95% credible interval, 2.83-45.89). Conclusions and Relevance: In the SECURED trial, noncuffed CVCs secured with SASS had fewer dislodgements compared with SSDs, with a lower cost per patient and an acceptable safety profile. Future efforts should be directed at SASS implementation at the health service level. Trial Registration: anzctr.org.au Identifier: ACTRN12620000783921.
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Cateterismo Venoso Central , Catéteres Venosos Centrales , Humanos , Femenino , Masculino , Niño , Lactante , Preescolar , Adolescente , Catéteres Venosos Centrales/efectos adversos , Cateterismo Venoso Central/efectos adversos , Cateterismo Venoso Central/métodos , Recién Nacido , Falla de Equipo/estadística & datos numéricosRESUMEN
AIMS: Subcutaneous implantable cardioverter-defibrillators (S-ICDs) have become established in preventing sudden cardiac death, with some advantages over transvenous defibrillator systems, including a lower incidence of lead failures. Despite technological advancements, S-ICD carriers may suffer from significant complications, such as premature battery depletion (PBD), that led to an advisory for nearly 40 000 patients. This multicentre study evaluated the incidence of PBD in a large set of S-ICD patients. METHODS AND RESULTS: Data from patients implanted with S-ICD models A209 and A219 between October 2012 and July 2023 across nine centres in Europe and the USA were reviewed. Incidence and implications of PBD, defined as clinically observed sudden drop in battery longevity, were analysed and compared to PBD with the definition of battery depletion within 60 months. Prospectively collected clinical data were obtained retrospectively from medical records, device telemetry, and manufacturer reports. This registry is listed on ClinicalTrials.gov (NCT05713708). Of the 1112 S-ICD devices analysed, 547 (49.2%) were equipped with a potentially affected capacitor linked to PBD occurrence, currently under Food and Drug Administration advisory. The median follow-up time for all patients was 46 [inter-quartile range (IQR) 24-63] months. Clinically suspected PBD was observed in 159 (29.1%) of cases, with a median time to generator removal or replacement of 65 (IQR 55-72) months, indicative of significant deviations from expected battery lifespan. Manufacturer confirmation of PBD was made in 91.7% of devices returned for analysis. No cases of PBD were observed in devices that were not under advisory. CONCLUSION: This manufacturer-independent analysis highlights a notable incidence of PBD in patients equipped with S-ICD models under advisory, and the rate of PBD in this study corresponds to the rate currently estimated by the manufacturer. To the best of our knowledge, this provides the largest contemporary peer-reviewed study cohort investigating the actual incidence of PBD in S-ICD patients. These findings emphasize the importance of post-market registries in collaboration between clinicians and the manufacturer to optimize safety and efficacy in S-ICD treatment.
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Desfibriladores Implantables , Suministros de Energía Eléctrica , Sistema de Registros , Humanos , Masculino , Femenino , Persona de Mediana Edad , Estudios Retrospectivos , Anciano , Estados Unidos/epidemiología , Muerte Súbita Cardíaca/prevención & control , Muerte Súbita Cardíaca/epidemiología , Europa (Continente)/epidemiología , Cardioversión Eléctrica/instrumentación , Cardioversión Eléctrica/efectos adversos , Falla de Equipo/estadística & datos numéricos , Factores de Tiempo , Análisis de Falla de Equipo/estadística & datos numéricos , AdultoRESUMEN
OBJECTIVE: The aim of this study was 1) to describe the rate of intrathecal baclofen (ITB)-associated complications at a large tertiary center, and 2) to evaluate the impact of patient-related factors on the likelihood of developing such complications. METHODS: A retrospective single-center study was carried out. A total of 301 eligible patients were included in the analysis. Univariate regression models were used to evaluate the impact of age, sex, diagnosis, ambulation status, modified Ashworth scale score, body mass index, diabetes status, and pain level on the likelihood of developing a device-related infection, pump malfunction, catheter malfunction, and other clinically significant complications. RESULTS: Overall, 27% of patients experienced an ITB-related complication. The most common complications included infection (6%, 18/301), pump malfunction (7.3%, 22/301), and catheter malfunction (14%, 42/301). The univariate analyses revealed that the patient's ambulatory status had a significant impact on the likelihood of developing a catheter-related malfunction. Furthermore, a trend toward significance was identified between patients' preoperative body mass index and device-related infection. Finally, the risk of suffering any ITB-related complications was statistically correlated with the number of years that had passed since the initial pump implantation. CONCLUSIONS: The authors' analysis reveals a previously underrecognized association between ambulatory status at the time of ITB pump implantation and the incidence of catheter-related complications, and confirms the impact of time since surgery on the risk of developing any ITB-related complication. The patient's age, sex, diagnosis, diabetes status, or pain level at baseline were not associated with the risk of complications. Collectively, these insights contribute novel information to the existing literature, providing practical value for physicians in guiding patient selection for ITB therapy.
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Baclofeno , Bombas de Infusión Implantables , Inyecciones Espinales , Relajantes Musculares Centrales , Humanos , Baclofeno/administración & dosificación , Baclofeno/efectos adversos , Masculino , Femenino , Persona de Mediana Edad , Estudios Retrospectivos , Adulto , Factores de Riesgo , Bombas de Infusión Implantables/efectos adversos , Relajantes Musculares Centrales/administración & dosificación , Relajantes Musculares Centrales/efectos adversos , Inyecciones Espinales/efectos adversos , Anciano , Adulto Joven , Espasticidad Muscular/tratamiento farmacológico , Falla de Equipo/estadística & datos numéricos , AdolescenteRESUMEN
Purpose To examine the clinical effect of lead length and lead orientation in patients with cardiac implantable electronic devices (CIEDs) and lead fragments or abandoned leads undergoing 1.5-T MRI. Materials and Methods This Health Insurance Portability and Accountability Act-compliant retrospective study included patients with CIEDs and abandoned leads or lead fragments undergoing 1.5-T MRI from March 2014 through July 2020. CIED settings before and after MRI were reviewed, with clinically significant variations defined as a composite of the change in capture threshold of at least 50%, in sensing of at least 40%, or in lead impedance of at least 30% between before MRI and after MRI interrogation. Adverse clinical events were assessed at MRI and up to 30 days after. Univariable and multivariable analysis was performed. Results Eighty patients with 126 abandoned CIED leads or lead fragments underwent 107 1.5-T MRI examinations. Sixty-seven patients (median age, 74 years; IQR, 66-78 years; 44 male patients, 23 female patients) had abandoned leads, and 13 (median age, 66 years; IQR, 52-74 years; nine male patients, four female patients) had lead fragments. There were no reported deaths, clinically significant arrhythmias, or adverse clinical events within 30 days of MRI. Three patients with abandoned leads had a significant change in the composite of capture threshold, sensing, or lead impedance. In a multivariable generalized estimating equation analysis, lead orientation, lead length, MRI type, and MRI duration were not associated with a significant change in the composite outcome. Conclusion Use of 1.5-T MRI in patients with abandoned CIED leads or lead fragments of varying length and orientation was not associated with adverse clinical events. Keywords: Cardiac Assist Devices, MRI, Cardiac Implantable Electronic Device Supplemental material is available for this article. © RSNA, 2024.
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Desfibriladores Implantables , Falla de Equipo , Imagen por Resonancia Magnética , Marcapaso Artificial , Humanos , Masculino , Femenino , Anciano , Desfibriladores Implantables/efectos adversos , Estudios Retrospectivos , Marcapaso Artificial/efectos adversos , Persona de Mediana Edad , Falla de Equipo/estadística & datos numéricosRESUMEN
Malnutrition is a common problem among hospitalized older patients. Peripheral parenteral nutrition (PN) can improve patient outcomes but can also lead to complications that affect future treatment. Older inpatients, in particular, are expected to be prone to these catheter-related complications. However, the impact of peripheral PN on older inpatients has been rarely investigated. In the current study, the impact of PN on short peripheral catheters (SPCs) was evaluated by comparing signs and symptoms at the time of catheter removal between 22 patients with PN and 27 without. In addition to external clinical assessment, sonographic investigations of the SPC site were performed. The prevalence of external signs and symptoms of complications was similar between the patients (all P > 0.05). However, subcutaneous edema was found by ultrasound in > 80% of patients with PN, compared with 55.6% of those without PN (P = 0.051). Unlike cases without PN, all patients with PN who presented with external signs and symptoms developed subcutaneous edema (P = 0.022). Multivariate analysis demonstrated that administration of PN was independently associated with subcutaneous edema (adjusted odds ratio = 6.88, 95% confidence interval = 1.083-75.486, P = 0.040). For several decades, phlebitis has been the primary focus of complications related to peripheral PN in clinical settings. However, our results imply that peripheral PN causes subcutaneous edema, which can lead to catheter failure in older inpatients. This study contributes to understanding the etiology of catheter failure during peripheral PN in this population.
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Edema , Nutrición Parenteral , Humanos , Masculino , Anciano , Femenino , Edema/etiología , Nutrición Parenteral/efectos adversos , Anciano de 80 o más Años , Cateterismo Periférico/efectos adversos , Falla de Equipo/estadística & datos numéricos , Ultrasonografía , Pacientes Internos , Tejido Subcutáneo , Estudios RetrospectivosRESUMEN
AIMS: Subcutaneous implantable cardioverter-defibrillators (S-ICDs) offer potentially distinct advantages over transvenous defibrillator systems. Recent randomized trials showed significantly lower lead failure rates than transvenous ICD. Still, S-ICDs remain associated with the risk of inappropriate shocks (IAS). While previous studies have reported varying causes of IAS, this study explores a rare cause of IAS, referred to as 'sense-B-noise.' It was recently described in case series, but its incidence has not been studied in a large cohort of S-ICD patients. METHODS AND RESULTS: We retrospectively reviewed data from patients implanted with S-ICD models 1010, A209, and A219 between October 2009 and July 2023 across nine centres in Europe and the USA. The analysis concentrated on determining the incidence and understanding the implications of sense-B-noise events. Sense-B-noise represents a rare manifestation of distinct electrogram abnormalities within the primary and alternate sensing vectors. Data were collected from medical records, device telemetry, and manufacturer reports for investigation. This registry is registered on clinicaltrials.gov (NCT05713708). Subcutaneous implantable cardioverter-defibrillator devices of the 1158 patients were analysed. The median follow-up time for all patients was 46 (IQR 23-64) months. In 107 patients (9.2%) ≥1 IAS was observed during follow-up. Sense-B-noise failure was diagnosed in six (0.5 and 5.6% of all IAS) patients, in all patients, the diagnosis was made after an IAS episode. Median lead dwell time in the affected patients was 23 (2-70) months. To resolve the sense-B-noise defect, in three patients reprogramming to the secondary vector was undertaken, and two patients underwent system removal with subsequent S-ICD reimplantation due to low amplitude in the secondary vector. In one patient, the secondary vector was initially programmed, and subsequently, an S-ICD system exchange was performed due to T-wave-oversensing IAS episodes. CONCLUSION: This multicentre analysis' findings shed light on a rare but clinically highly significant adverse event in S-ICD therapy. To our knowledge, we provide the first systematic multicentre analysis investigating the incidence of sense-B-noise. Due to being difficult to diagnose and limited options for resolution, management of sense-B-noise is challenging. Complete system exchange may be the only option for some patients. Educating healthcare providers involved in S-ICD patient care is crucial for ensuring accurate diagnosis and effective management of sense-B-noise issues.
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Desfibriladores Implantables , Cardioversión Eléctrica , Sistema de Registros , Humanos , Masculino , Estudios Retrospectivos , Femenino , Persona de Mediana Edad , Incidencia , Cardioversión Eléctrica/instrumentación , Cardioversión Eléctrica/efectos adversos , Anciano , Europa (Continente)/epidemiología , Falla de Equipo/estadística & datos numéricos , Estados Unidos/epidemiología , Factores de RiesgoRESUMEN
OBJECTIVES: To compare catheter-related outcomes of individuals who received a tunnelled femorally inserted central catheter (tFICC) with those who received a peripherally inserted central catheter (PICC) in the upper extremities. DESIGN: A propensity-score matched cohort study. SETTING: A 980-bed tertiary referral hospital in South West Sydney, Australia. PARTICIPANTS: In-patients referred to the hospital central venous access service for the insertion of a central venous access device. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome of interest was the incidence of all-cause catheter failure. Secondary outcomes included the rates of catheters removed because of suspected or confirmed catheter-associated infection, catheter dwell and confirmed upper or lower extremity deep vein thrombosis (DVT). RESULTS: The overall rate of all-cause catheter failure in the matched tFICC and PICC cohort was 2.4/1000 catheter days (95% CI 1.1 to 4.4) and 3.0/1000 catheter days (95% CI 2.3 to 3.9), respectively, and when compared, no difference was observed (difference -0.63/1000 catheter days, 95% CI -2.32 to 1.06). We found no differences in catheter dwell (mean difference of 14.2 days, 95% CI -6.6 to 35.0, p=0.910); or in the cumulative probability of failure between the two groups within the first month of dwell (p=0.358). No significant differences were observed in the rate of catheters requiring removal for confirmed central line-associated bloodstream infection (difference 0.13/1000 catheter day, 95% CI -0.36 to 0.63, p=0.896). Similarly, no significant differences were found between the groups for confirmed catheter-related DVT (difference -0.11 per 1000 catheter days, 95% CI -0.26 to 0.04, p=1.00). CONCLUSION: There were no differences in catheter-related outcomes between the matched cohort of tFICC and PICC patients, suggesting that tFICCs are a possible alternative for vascular access when the veins of the upper extremities or thoracic region are not viable for catheterisation.
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Infecciones Relacionadas con Catéteres , Cateterismo Venoso Central , Cateterismo Periférico , Puntaje de Propensión , Humanos , Femenino , Masculino , Persona de Mediana Edad , Infecciones Relacionadas con Catéteres/epidemiología , Infecciones Relacionadas con Catéteres/etiología , Cateterismo Venoso Central/efectos adversos , Cateterismo Venoso Central/métodos , Cateterismo Periférico/efectos adversos , Anciano , Catéteres Venosos Centrales/efectos adversos , Estudios de Cohortes , Australia/epidemiología , Adulto , Catéteres de Permanencia/efectos adversos , Remoción de Dispositivos/estadística & datos numéricos , Falla de Equipo/estadística & datos numéricosRESUMEN
INTRODUCTION: Short peripheral intravenous catheter (PIVC) failure is a common complication that is generally underdiagnosed. Some studies have evaluated the factors associated with these complications, but the impact of care complexity individual factors and nurse staffing levels on PIVC failure is still to be assessed. The aim of this study was to determine the incidence and risk factors of PIVC failure in the public hospital system of the Southern Barcelona Metropolitan Area. METHODS: A retrospective multicentre observational cohort study of hospitalised adult patients was conducted in two public hospitals in Barcelona from 1st January 2016 to 31st December 2017. All adult patients admitted to the hospitalisation ward were included until the day of discharge. Patients were classified according to presence or absence of PIVC failure. The main outcomes were nurse staffing coverage (ATIC patient classification system) and 27-care complexity individual factors. Data were obtained from electronic health records in 2022. RESULTS: Of the 44,661 patients with a PIVC, catheter failure was recorded in 2,624 (5.9%) patients (2,577 [5.8%] phlebitis and 55 [0.1%] extravasation). PIVC failure was more frequent in female patients (42%), admitted to medical wards, unscheduled admissions, longer catheter dwell time (median 7.3 vs 2.2 days) and those with lower levels of nurse staffing coverage (mean 60.2 vs 71.5). Multivariate logistic regression analysis revealed that the female gender, medical ward admission, catheter dwell time, haemodynamic instability, uncontrolled pain, communication disorders, a high risk of haemorrhage, mental impairments, and a lack of caregiver support were independent factors associated with PIVC failure. Moreover, higher nurse staffing were a protective factor against PIVC failure (AUC, 0.73; 95% confidence interval [CI]: 0.72-0.74). CONCLUSION: About 6% of patients presented PIVC failure during hospitalisation. Several complexity factors were associated with PIVC failure and lower nurse staffing levels were identified in patients with PIVC failure. Institutions should consider that prior identification of care complexity individual factors and nurse staffing coverage could be associated with a reduced risk of PIVC failure.
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Cateterismo Periférico , Humanos , Femenino , Masculino , Estudios Retrospectivos , Cateterismo Periférico/efectos adversos , Persona de Mediana Edad , Anciano , Factores de Riesgo , Adulto , Admisión y Programación de Personal , Falla de Equipo/estadística & datos numéricos , Personal de Enfermería en Hospital/estadística & datos numéricos , Hospitalización/estadística & datos numéricos , España/epidemiologíaRESUMEN
OBJECTIVE: This study aimed to investigate the causes of lumboperitoneal (LP) shunt failure and determine risk factors for lumbar catheter fracture. METHODS: We retrospectively investigated 149 patients who underwent LP shunting in our hospital between January 2012 and March 2023. Shunt reconstruction occurred in 22 patients (14.8%). Among these, cause of failure was lumbar catheter fracture in 5 (22.7%). Patient backgrounds, cause of LP shunt failure, surgical technique factors, and anatomical characteristics were extracted for comparative analysis and risk factors of lumbar catheter fracture were analyzed. RESULTS: Compared with the no reoperation group (n = 127), patients in the lumbar catheter fracture tended to be younger (63 ± 20 vs. 72 ± 11 years) and favorable neurologic status (modified Rankin scale score ≤2) after initial LP shunt; however, the differences were not significant. Lumbar lordosis was significantly higher in the lumbar catheter fracture group (52.7°± 14.8° vs. 37.1°± 12.3°; P = 0.0067). CONCLUSIONS: Excessive lumbar lordosis is a risk factor for lumbar catheter fracture in patients undergoing LP shunting. Younger age and higher level of postoperative activities of daily living might also be associated with lumbar catheter fracture.
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Falla de Equipo , Lordosis , Vértebras Lumbares , Humanos , Femenino , Masculino , Persona de Mediana Edad , Anciano , Factores de Riesgo , Lordosis/cirugía , Estudios Retrospectivos , Vértebras Lumbares/cirugía , Vértebras Lumbares/lesiones , Falla de Equipo/estadística & datos numéricos , Anciano de 80 o más Años , Derivaciones del Líquido Cefalorraquídeo/efectos adversos , Adulto , Región Lumbosacra/cirugía , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/epidemiologíaRESUMEN
INTRODUCTION: Pancreatic duct stents (PDS) are widely used for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. However, there is a paucity of data regarding the adverse events associated with PDS placement. This study aims to investigate the reported adverse events and device failures related to PDS, utilizing the Manufacturer and User Facility Device Experience (MAUDE) database maintained by the U.S. Food and Drug Administration (FDA). METHODS: Post-marketing surveillance data from January 2013 to December 8, 2023, were extracted from the FDA's MAUDE database to analyze the reports pertaining to the use of commonly used PDS. The primary outcomes of interest were device issues and patient-related adverse events. Statistical analysis was performed using Microsoft Excel 2010, with the calculation of pooled numbers and percentages for each device and patient adverse event. RESULTS: A total of 579 device issues and 194 patient-related adverse events were identified. Device issues were primarily attributed to stent deformation (n = 72; 12.4%), followed by migration of the device into the pancreatic duct or expulsion out of the duct (n = 60; 10.4%), and stent fracture/breakage (n = 55; 9.4%). Among the patient-reported adverse events, inflammation was the most common (n = 26; 13.4%), followed by reports of stents becoming embedded in tissue (n = 21; 10.8%) and stent occlusion/obstruction (n = 16; 8.2%). The most prevalent device failures associated with Advanix stents were material deformation, with perforation (n = 3, 30%) being the most frequently reported adverse event. Concerning Geenen stents, migration or expulsion of the device (n = 34, 16.9%) constituted the most common device-related adverse events, while inflammation (n = 20, 16.7%) was the most frequently reported patient-related issue. For Zimmon stents, migration or expulsion of the device (n = 22, 8.8%) were the most frequently reported device-related problems, whereas perforation (n = 7, 10.9%) and bleeding (n = 7, 10.9%) were the most frequent patient-related adverse events. CONCLUSION: Our findings highlight important device and patient adverse events that endoscopists and referring providers should be aware of before considering pancreatic stent placement.
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Bases de Datos Factuales , Conductos Pancreáticos , Vigilancia de Productos Comercializados , Falla de Prótesis , Stents , United States Food and Drug Administration , Humanos , Estados Unidos/epidemiología , Stents/efectos adversos , Conductos Pancreáticos/cirugía , Colangiopancreatografia Retrógrada Endoscópica/efectos adversos , Colangiopancreatografia Retrógrada Endoscópica/instrumentación , Pancreatitis/etiología , Pancreatitis/epidemiología , Pancreatitis/prevención & control , Falla de Equipo/estadística & datos numéricos , Migración de Cuerpo Extraño/etiología , Migración de Cuerpo Extraño/epidemiología , Migración de Cuerpo Extraño/prevención & controlRESUMEN
OBJECTIVE: To determine the prevalence and severity of SpaceOAR-related adverse events using the Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: We analyzed SpaceOAR-related adverse event reports in the Manufacturer and User Facility Device Experience (MAUDE) database from January 2015 to May 2023. For each report, the event type, associated device and patient problems, event description, event timing, and event severity stratified by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE) grading system were recorded. RESULTS: From 2015 to 2022, 206,619 SpaceOAR devices were sold. From January 2015 to May 2023, we identified 981 reports describing 990 SpaceOAR-related adverse events. Malfunctions were the most common event type (N = 626), followed by patient injuries (N = 350) with few reported deaths (N = 5). Device positioning problems were the most frequent device issue (N = 686). Pain was the most reported patient problem (N = 216). Abscesses and fistulas related to the device were each reported in 91 events. A noteworthy portion of relevant adverse events occurred before the initiation of radiation (N = 35, 22.4%), suggesting the device, rather than the radiation, was responsible. In total, 470 (50.2%) and 344 (36.7%) of the adverse events were CTCAE grade 1 and 2, respectively. There were 123 (13.1%) events that were CTCAE grade ≥3. CONCLUSION: We identified multiple reports of SpaceOAR-related adverse events, many of which are more serious than have been reported in clinical trials. While SpaceOAR use is common, suggesting these events are rare, these data highlight the need for continued postmarket surveillance.
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Hidrogeles , Neoplasias de la Próstata , Humanos , Neoplasias de la Próstata/radioterapia , Masculino , Hidrogeles/efectos adversos , Falla de Equipo/estadística & datos numéricosRESUMEN
OBJECTIVE: In light of the recent US Food and Drug Administration (FDA) Class 2 safety recall notice for anastomotic coupling devices, it is important to understand related adverse events. The aim of this study was to characterize adverse events in anastomotic coupling devices for microvascular reconstruction. METHODS: A retrospective cross-sectional analysis using the 2011 to 2021 US FDA Manufacturer and User Facility Device Experience (MAUDE) database. All reports of adverse events involving anastomotic coupling devices were retrieved from the MAUDE database. Descriptive statistics were used to analyze categorized events. RESULTS: There were a total of 293 documented adverse events related to anastomotic coupling devices. These adverse events resulted in 91 (31.1 %) patient injuries and 239 (81.6 %) device malfunctions. The most frequent patient problems were thrombosis/hematoma (n = 38; 41.8 %), unspecified injury (n = 31; 34.1 %), and failure to anastomose (n = 13; 14.3 %). Free flap necrosis was reported in 42 % of thrombosis/hematoma cases (n = 16). The most common malfunctions were devices operating differently than expected (n = 74; 31.0 %), connection problems (n = 41; 17.2 %), and twisted/bent material (n = 19; 7.9 %). There was no significant trend in the number of adverse events over the study period (p > 0.05). CONCLUSIONS: Adverse events from anastomotic coupling devices represent an important and modifiable factor in free tissue failure. Adverse events are predominately related to devices operating differently than expected and may result in vascular compromise of the free flap. Reconstructive surgeons should be cognizant of defective anastomotic coupling devices and be prepared to utilize traditional hand-sewn anastomosis.
Asunto(s)
Anastomosis Quirúrgica , Microcirugia , Procedimientos de Cirugía Plástica , Humanos , Estudios Retrospectivos , Anastomosis Quirúrgica/efectos adversos , Anastomosis Quirúrgica/instrumentación , Estudios Transversales , Procedimientos de Cirugía Plástica/instrumentación , Procedimientos de Cirugía Plástica/efectos adversos , Procedimientos de Cirugía Plástica/métodos , Microcirugia/instrumentación , Microcirugia/efectos adversos , Falla de Equipo/estadística & datos numéricos , Estados Unidos , Trombosis/etiología , United States Food and Drug Administration , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Colgajos Tisulares Libres/efectos adversos , Bases de Datos FactualesRESUMEN
BACKGROUND AND AIMS: Invasive devices are widely used in healthcare settings; however, pediatric patients are especially vulnerable to invasive device-associated harm. This study aimed to explore invasive device utility, prevalence, harm, and clinical practice across three Australian pediatric tertiary hospitals. METHODS: In 2022-2023, a multi-center, observational, rolling-point-prevalence survey was conducted. Fifty-per-cent of inpatients were systemically sampled by random allocation. Patients with devices were then followed for up to 3-days for device-related complications/failures and management/removal characteristics. RESULTS: Of the 285 patients audited, 78.2% had an invasive device (n = 412 devices), with a median of 1 device-per-patient (interquartile range 1-2), with a maximum of 13 devices-per-patient. Over half of devices were vascular access devices (n = 223; 54.1%), followed by gastrointestinal devices (n = 112; 27.2%). The point-prevalence of all device complications on Day 0 was 10.7% (44/412 devices) and period-prevalence throughout the audit period was 27.7% (114/412 devices). The period-prevalence of device failure was 13.4% (55/412 devices). CONCLUSIONS: The study highlighted a high prevalence of invasive devices among hospitalized patients. One-in-ten devices failed during the audit period. These findings underscore the need for vigilant monitoring and improved strategies to minimize complications and enhance the safety of invasive devices in pediatric hospital settings. IMPACT: A high prevalence of invasive devices among hospitalized patients was reported. Of the 285 patients audited, almost 80% had an invasive device (total 412 devices), with a median of 1 device-per-patient and a maximum of 13 devices-per-patient. The most common devices used in pediatric healthcare are vascular access devices (n = 223; 54.1%), however, 16% (n = 36) of these devices failed, and one-third had complications. The point prevalence of all device complications at day 0 was 10.7% (44 out of 412 devices), with a period prevalence of 27.7% (114 out of 412 devices) throughout the audit period.
Asunto(s)
Centros de Atención Terciaria , Humanos , Niño , Masculino , Femenino , Preescolar , Prevalencia , Lactante , Australia/epidemiología , Adolescente , Falla de Equipo/estadística & datos numéricos , Dispositivos de Acceso Vascular/efectos adversos , Recién Nacido , Encuestas y Cuestionarios , Hospitales PediátricosRESUMEN
OBJECTIVE: Port-a-caths are implanted intravascular chest ports that enable venous access. With more port placements performed by interventional radiologists, it is important to discern differences in infection and complication rates between double- and single-lumen ports. METHODS: We retrospectively reviewed 1,385 port placements over 2 years at the University of Miami. Patients were grouped by single- or double-lumen ports. Data on duration of catheter stay, bloodstream infections, malfunctions, and other complications (fibrin sheath, thrombosis, catheter malposition) were collected. Multivariate Cox regression was performed to identify variables predicting port infection. RESULTS: The mean patient age was 58.8 years; the mean BMI was 26.9 kg/m2; and 61.5% of these patients were female. Our search revealed 791 double-lumen ports (57.1%) and 594 single-lumen ports (42.9%). The median follow-up was 668 days (range, 2-1,297). Double-lumen ports were associated with significantly higher rates of bacteremia (2.78% vs 0.84%; P = .02), port malfunction (8.3% vs 2.0%; P < .001), fibrin sheath formation (2.2% vs 0.5%; P < .02), catheter tip malposition (1.0% vs 0; P = .01), and catheter-associated thrombosis (1.4% vs 0; P = .003). Multivariate Cox regression analysis, after adjusting for other variables, showed that double-lumen chest ports had 2.98 times (95% confidence interval, 1.12-7.94) the hazard rate of single-lumen ports for developing bloodstream infection (P = .029). CONCLUSIONS: Double-lumen chest ports are associated with increased risk for bloodstream infection, malfunction, fibrin sheath formation, catheter tip malposition, and catheter-associated thrombosis. Interventional radiologists may consider placing single-lumen ports if clinically feasible; however, future studies are needed to determine clinical significance. The study limitations included the retrospective study design and the potential loss of patient follow-up.
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Bacteriemia , Dispositivos de Acceso Vascular , Femenino , Persona de Mediana Edad , Bacteriemia/epidemiología , Infecciones Relacionadas con Catéteres/epidemiología , Falla de Equipo/estadística & datos numéricos , Análisis Multivariante , Radiólogos , Estudios Retrospectivos , Trombosis/epidemiología , Dispositivos de Acceso Vascular/efectos adversos , Dispositivos de Acceso Vascular/microbiología , Humanos , MasculinoRESUMEN
OBJECTIVE: To evaluate the feasibility of O-arm navigation of bilateral dual sacral-alar-iliac (SAI) screws compared with conventional bilateral single SAI and S1 pedicle screws for pelvic anchors in cases of adult spinal deformity. METHODS: This retrospective, comparative study included 39 patients who underwent corrective fusion using SAI screws from T10 to the pelvis. Patients were divided into 2 groups according to the number of SAI screws placed during adult spinal deformity surgery: single SAI screw (group S, 17 cases) and dual SAI screws (group D, 22 cases). The incidence of rod breakage, proximal junctional kyphosis, screw loosening, reoperation, and global alignment in each group was estimated. Postoperative patient-reported outcomes were measured using the Oswestry Disability Index, Japanese Orthopaedic Association Back Pain Evaluation Questionnaire, and visual analog scale. RESULTS: The incidence of SAI screw loosening was significantly lower in group D than in group S (23% vs. 65%, P = 0.011). The rod breakage incidence was 0% and 12% in groups D and S, respectively (P = 0.17). There were no significant differences in the postoperative global alignment and clinical outcomes between the 2 groups. CONCLUSIONS: Dual SAI screws were associated with a significantly reduced incidence of screw loosening compared with single SAI screws. The bilateral dual SAI screws technique for pelvic anchors is feasible for the treatment of patients with adult spinal deformity.
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Ilion/cirugía , Procedimientos Neuroquirúrgicos/métodos , Tornillos Pediculares , Región Sacrococcígea/cirugía , Columna Vertebral/anomalías , Columna Vertebral/cirugía , Anciano , Dolor de Espalda/diagnóstico , Evaluación de la Discapacidad , Falla de Equipo/estadística & datos numéricos , Femenino , Humanos , Incidencia , Cifosis/epidemiología , Masculino , Persona de Mediana Edad , Dimensión del Dolor , Complicaciones Posoperatorias/epidemiología , Reoperación/estadística & datos numéricos , Estudios Retrospectivos , Fusión Vertebral/métodos , Resultado del TratamientoRESUMEN
BACKGROUND: We aimed to determine the incidence, nature of and predisposing factors for risk events (REs) that occur during the intrahospital transport of patients from the ED. METHODS: We undertook a prospective, observational study of intrahospital patient transports from a single ED between 30 January and 20 March 2020. An investigator attended each transport and recorded any RE on a specifically designed data collection document. An RE was any mishap, even if not foreseen, that had the potential to cause the patient harm. A patient equipment number was assigned based on the number of pieces of equipment required during the transport. Poisson regression generated incidence rate ratios (IRRs) and determined risk factors for REs. RESULTS: Of 738 transports, 289 (39.1%, 95% CI 35.6% to 42.8%) had at least one RE. The total of 521 REs comprised 125 patient-related, 279 device-related and 117 line/catheter-related REs. The most common included trolley collisions (n=142), intravenous fluid line catching/tangling (n=93), agitation/aggression events (n=31) and cardiac monitoring issues (n=31). Thirty-four (6.5%) REs resulted in an undesirable patient outcome, most commonly distress and pain. Predisposing factors for REs included an equipment number ≥3 (IRR 5.68, 95% CI 3.95 to 8.17), transport to a general ward (IRR 2.68, 95% CI 2.12 to 3.39), hypertension (IRR 1.93, 95% CI 1.07 to 3.50), an abnormal temperature and a GCS<14. CONCLUSIONS: REs are common in transport of patients from the ED and can result in undesirable patient outcomes. Adequate pre-transfer preparation, especially securing equipment and lines, would result in a reduced risk.
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Servicio de Urgencia en Hospital/normas , Transferencia de Pacientes/normas , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Niño , Preescolar , Enfermedad Crítica/terapia , Servicio de Urgencia en Hospital/organización & administración , Servicio de Urgencia en Hospital/estadística & datos numéricos , Falla de Equipo/estadística & datos numéricos , Femenino , Humanos , Lactante , Masculino , Persona de Mediana Edad , Transferencia de Pacientes/clasificación , Transferencia de Pacientes/estadística & datos numéricos , Estudios Prospectivos , Agitación Psicomotora/tratamiento farmacológico , Agitación Psicomotora/prevención & control , Factores de Riesgo , VictoriaRESUMEN
OBJECTIVE: To investigate the protective effect of a hydrocolloid nasal dressing on the incidence and severity of nasal injury and continuous positive airway pressure (CPAP) failure in preterm infants receiving nasal CPAP (N-CPAP). METHODS: A randomized controlled trial was conducted over 4 months in 2019 at level 3 neonatal ICUs in two hospitals affiliated with Isfahan University of Medical Sciences, Iran. Eighty eligible infants were born at 32 weeks of gestation or younger and/or with a birth weight of 1,500 g or less and had received between 4 and 72 hours of CPAP. Infants were randomly assigned to two groups; the intervention group used a protective dressing, and the control group received routine care. Data collection tools included a demographic questionnaire and nasal injury assessment score chart. MAIN OUTCOME MEASURES: The incidence and severity of nasal injury in preterm infants undergoing N-CPAP. RESULTS: Infants in the intervention group had a significantly lower incidence and severity of nasal injury compared with the control group: 15 of 40 (37.5%) versus 37 of 40 (92.5%; P < .001). Overall, the injuries identified in this study were mostly mild and moderate, with only three severe injuries in the intervention group and five in the control group. No significant differences were detected in CPAP failure (P > .05). CONCLUSIONS: The studied nasal barrier dressing is a safe and convenient solution to reduce nasal injury in preterm infants receiving N-CPAP.