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RATIONALE & OBJECTIVE: Hemodialysis catheter dysfunction is an important problem for patients with kidney failure. The optimal design of the tunneled catheter tip is unknown. This study evaluated the association of catheter tip design with the duration of catheter function. STUDY DESIGN: Observational cohort study using data from the nationwide REDUCCTION trial. SETTING & PARTICIPANTS: 4,722 adults who each received hemodialysis via 1 or more tunneled central venous catheters in 37 Australian nephrology services from December 2016 to March 2020. EXPOSURE: Design of tunneled hemodialysis catheter tip, classified as symmetrical, step, or split. OUTCOME: Time to catheter dysfunction requiring removal due to inadequate dialysis blood flow assessed by the treating clinician. ANALYTICAL APPROACH: Mixed, 3-level accelerated failure time model, assuming a log-normal survival distribution. Secular trends, the intervention, and baseline differences in service, patient, and catheter factors were included in the adjusted model. In a sensitivity analysis, survival times and proportional hazards were compared among participants' first tunneled catheters. RESULTS: Among the study group, 355 of 3,871 (9.2%), 262 of 1,888 (13.9%), and 38 of 455 (8.4%) tunneled catheters with symmetrical, step, and split tip designs, respectively, required removal due to dysfunction. Step tip catheters required removal for dysfunction at a rate 53% faster than symmetrical tip catheters (adjusted time ratio, 0.47 [95% CI, 0.33-0.67) and 76% faster than split tip catheters (adjusted time ratio, 0.24 [95% CI, 0.11-0.51) in the adjusted accelerated failure time models. Only symmetrical tip catheters had performance superior to step tip catheters in unadjusted and sensitivity analyses. Split tip catheters were infrequently used and had risks of dysfunction similar to symmetrical tip catheters. The cumulative incidence of other complications requiring catheter removal, routine removal, and death before removal were similar across the 3 tip designs. LIMITATIONS: Tip design was not randomized. CONCLUSIONS: Symmetrical and split tip catheters had a lower risk of catheter dysfunction requiring removal than step tip catheters. FUNDING: Grants from government (Queensland Health, Safer Care Victoria, Medical Research Future Fund, National Health and Medical Research Council, Australia), academic (Monash University), and not-for-profit (ANZDATA Registry, Kidney Health Australia) sources. TRIAL REGISTRATION: Registered at ANZCTR with study number ACTRN12616000830493. PLAIN-LANGUAGE SUMMARY: Central venous catheters are widely used to facilitate vascular access for life-sustaining hemodialysis treatments but often fail due to blood clots or other mechanical problems that impede blood flow. A range of adaptations to the design of tunneled hemodialysis catheters have been developed, but it is unclear which designs have the greatest longevity. We analyzed data from an Australian nationwide cohort of patients who received hemodialysis via a tunneled catheter and found that catheters with a step tip design failed more quickly than those with a symmetrical tip. Split tip catheters performed well but were infrequently used and require further study. Use of symmetrical rather than step tip hemodialysis catheters may reduce mechanical failures and unnecessary procedures for patients.
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Cateterismo Venoso Central , Cateteres Venosos Centrais , Adulto , Humanos , Cateterismo Venoso Central/efeitos adversos , Estudos de Coortes , Cateteres de Demora/efeitos adversos , Austrália , Diálise Renal , Cateteres Venosos Centrais/efeitos adversosRESUMO
INTRODUCTION: Pacemaker-mediated tachycardia is a known arrhythmia in patients with dual chamber pacemakers and defibrillators and intact ventriculoatrial (VA) conduction. We report a case of pacemaker-mediated reentrant arrhythmia (PMRA) in a patient with an atrioventricular (AV) synchronous leadless pacemaker. METHODS AND RESULTS: A 91-year-old female presented with 2:1 AV conduction and received an AV synchronous leadless pacemaker. She had atrial mechanical sense-ventricular paced beats between heart rates of 80-100 bpm more than 80% of the time. She was found to have a new cardiomyopathy and was referred for placement of biventricular pacemaker. At the time of device implantation, her electrocardiogram showed ventricular pacing with a short RP interval and superiorly directed P waves. Changes in the ventricular pacing rate resulted in changes in the atrial rate. Following device placement, her heart rate decreased to the lower rate limit of her pacemaker. The atrial mechanical sense impulse most likely was generated by a retrograde conducted P wave resulting in near incessant PMRA. CONCLUSION: PMRA may occur in patients who receive an AV synchronous leadless pacemaker with intact VA conduction and sinoatrial node dysfunction. Due to the lower rates of PMRA, this arrhythmia may be underrecognized. Interventions for and implications of PMRA need further investigation.
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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 Implantáveis , Cardioversão Elétrica , Sistema de Registros , Humanos , Masculino , Estudos Retrospectivos , Feminino , Pessoa de Meia-Idade , Incidência , Cardioversão Elétrica/instrumentação , Cardioversão Elétrica/efeitos adversos , Idoso , Europa (Continente)/epidemiologia , Falha de Equipamento/estatística & dados numéricos , Estados Unidos/epidemiologia , Fatores de RiscoRESUMO
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 Implantáveis , Fontes de Energia Elétrica , Sistema de Registros , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Estudos Retrospectivos , Idoso , Estados Unidos/epidemiologia , Morte Súbita Cardíaca/prevenção & controle , Morte Súbita Cardíaca/epidemiologia , Europa (Continente)/epidemiologia , Cardioversão Elétrica/instrumentação , Cardioversão Elétrica/efeitos adversos , Falha de Equipamento/estatística & dados numéricos , Fatores de Tempo , Análise de Falha de Equipamento/estatística & dados numéricos , AdultoRESUMO
The DF-4 defibrillator standard has been rapidly adopted due to its convenience at implantation. There are however trade-offs compared to the traditional DF-1 standard that are underappreciated. This viewpoint outlines the advantages and limitations of current defibrillator lead standards that should be kept in mind, as they impact the options that are available to deal with issues that may arise.
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Terapia de Ressincronização Cardíaca , Desfibriladores Implantáveis , Insuficiência Cardíaca , Humanos , Insuficiência Cardíaca/terapiaRESUMO
BACKGROUND: Inappropriate shock (IAS) caused by subcutaneous air entrapment (AE) in an early period after subcutaneous implantable cardioverter defibrillator (S-ICD) implantation has been reported, however, no detailed data on air volume are available. We evaluated the subcutaneous air volume after implantation and its absorption rate one week after implantation. METHODS: Patients who underwent S-ICD implantation in our hospital received chest CT scans immediately after implantation and followed up 1 week later. The total subcutaneous air volume, air around the generator, the distal electrode, and the proximal electrode within 3 cm were calculated using a three-dimensional workstation. Fat areas at the level of the lower edge of the generator were also analyzed. RESULT: Fifteen patients received CT immediately after implantation. The mean age was 45.6 ± 17.9 (66.7% of men), and the mean body mass index was 24.3 ± 3.3. The three-incision technique was applied in seven patients and two-incision technique was in the latter eight patients. The mean total subcutaneous air volume was 18.54 ± 7.50 mL. Air volume around the generator, the distal electrode, and the proximal electrode were 11.05 ± 5.12, 0.72 ± 0.72, and 0.88 ± 0.87 mL, respectively. Twelve patients received a follow-up CT 1 week later. The mean total subcutaneous air was 0.25 ± 0.45 mL, showing a 98.7% absorption rate. CONCLUSION: Although subcutaneous air was observed in all patients after S-ICD implantation, most of the air was absorbed within 1 week, suggesting a low occurrence of AE-related IAS after a week postoperation.
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Desfibriladores Implantáveis , Masculino , Humanos , Adulto , Pessoa de Meia-Idade , Desfibriladores Implantáveis/efeitos adversos , Cardioversão Elétrica , Implantação de Prótese/efeitos adversos , Implantação de Prótese/métodos , Tomografia Computadorizada por Raios X , Tomografia , Resultado do TratamentoRESUMO
INTRODUCTION: Micra AV Transcatheter Pacing System (TPS) represents an innovative second-generation leadless pacemaker which represents an effective alternative to conventional devices in selected cases. Intrinsic malfunctions of these devices are rare, requiring sometimes their retrieval. When performed in experienced centers, this procedure is safe. CASE PRESENTATION: We describe a case of sudden battery malfunction of a Micra AV TPS, which required the extraction and the placement of a new pacing system in the right ventricle. DISCUSSION: This case, which has never been reported, highlights the need to a careful fluoroscopic evaluation and the usefulness of remote monitoring.
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Arritmias Cardíacas , Marca-Passo Artificial , Humanos , Resultado do Tratamento , Desenho de Equipamento , Marca-Passo Artificial/efeitos adversos , Estimulação Cardíaca ArtificialRESUMO
Although ventricular capture during the atrial threshold test is possible, there are rare reports on the insulation defect and inactive leads thereof. In this case, we present a pacemaker-dependent patient with a history of pacemaker generator replacements. The patient experienced ventricular capture induced by atrial pacing due to adhesion of the atrial and ventricular leads with an insulation defect. The atrial lead was abandoned and a new lead was implanted. However, there was a significant decrease in ventricular impedance detected shortly after the new lead was implanted. When observing the phenomenon of atrial pacing-induced ventricular depolarization, one uncommon reason to consider is lead adhesive wear. It is important to pay attention to the contact and bending sites of the leads.
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Falha de Equipamento , Marca-Passo Artificial , Humanos , Marca-Passo Artificial/efeitos adversos , Eletrodos Implantados/efeitos adversos , Masculino , Estimulação Cardíaca Artificial/métodos , Idoso , Átrios do Coração/fisiopatologiaRESUMO
INTRODUCTION: Catheter ablation (CA) can interfere with cardiac implantable electronic device (CIED) function. The safety of CA in the 1st year after CIED implantation/lead revision is uncertain. METHODS: This single center, retrospective cohort included patients who underwent CA between 2012 and 2017 and had a CIED implant/lead revision within the preceding year. We assessed the frequency of device/lead malfunctions in this population. RESULTS: We identified 1810 CAs in patients between 2012 and 2017, with 170 CAs in 163 patients within a year of a CIED implant/lead revision. Mean age 68 ± 12 years (68% men). Time between the CIED procedure and CA was 158 ± 99 days. The CA procedures included AF ablation (n = 57, 34%), AV node ablation (n = 40, 24%), SVT ablation (n = 37, 22%), and PVC/VT ablations (n = 36, 21%). The cumulative frequency of lead dislodgement, significant CIED dysfunction, and/or CIED-related infection following CA was (n = 1/170, 0.6%). There was a single atrial lead dislodgement (0.6%). There were no instances of power-on-reset or CIED-related infection. Following CA, there was no significant difference in RA or RV lead sensing (p = 0.52 and 0.84 respectively) or thresholds (p = 0.94 and 0.17 respectively). The RA impedance slightly decreased post-CA from 474 ± 80 Ohms to 460 ± 73 Ohms (p = 0.002), as did the RV impedance (from 515 ± 111 Ohms to 497 ± 98 Ohms, p < 0.0001). CONCLUSIONS: CA can be performed within 1 year following CIED implantation/lead revision with a low risk of CIED/lead malfunction or lead dislodgement. The ideal time to perform CA after a CIED remains uncertain.
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Ablação por Cateter , Desfibriladores Implantáveis , Marca-Passo Artificial , Humanos , Masculino , Feminino , Estudos Retrospectivos , Idoso , Ablação por Cateter/instrumentação , Falha de EquipamentoRESUMO
PURPOSE: Proximal catheter obstruction is the leading cause of ventricular shunt failure in pediatric patients. Our aim is to evaluate various types of shunt catheters to assess in vitro cellular adhesion and obstruction. METHODS: Four catheter types were tested: (1) antibiotic and impregnated, (2) barium-stripe polyvinylpyrrolidone coated (PVP), (3) barium-stripe, and (4) barium-impregnated. Catheters were seeded with choroid plexus epithelial cells to test cellular adhesion and inoculated with the same cells to test flow/pressure performance under choroid plexus growth conditions. Ventricular catheters were placed into a three-dimensional printed phantom ventricular replicating system through which artificial cerebrospinal fluid (CSF) was pumped. Differential pressure sensors were used to measure catheter performance. RESULTS: PVP catheters had the lowest median cell attachment (10 cells) compared to antibiotic-impregnated (230 cells), barium stripe (513 cells), and barium-impregnated (146 cells) catheters after culture (p < 0.01). In addition, PVP catheters (- 0.247 cm H2O) and antibiotic-impregnated (- 1.15 cm H2O) catheters had significantly lower pressure in the phantom ventricular system compared to the barium stripe (0.167 cm H2O) and barium-impregnated (0.618 cm H2O; p < 0.01) catheters. CONCLUSIONS: PVP catheters showed less cellular adhesion and, together with antibiotic-impregnated catheters, required less differential pressure to maintain a consistent flow. Our findings suggest clinical relevance for using PVP ventricular catheters in patients with recurrent catheter obstruction by choroid plexus.
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Plexo Corióideo , Hidrocefalia , Criança , Humanos , Plexo Corióideo/cirurgia , Povidona , Bário , Derivações do Líquido Cefalorraquidiano/métodos , Catéteres , Antibacterianos/uso terapêutico , Hidrocefalia/cirurgia , Hidrocefalia/tratamento farmacológico , Cateteres de DemoraRESUMO
IntroductionEvaluation of shunt for malfunction and blockage is a common neurosurgical clinical scenario in day-to-day paediatric neurosurgery practice. Parental concern for shunt malfunction is normally considered a reliable indication for undertaking further assessment of a child with a shunt. Accuracy of parental diagnosis of shunt malfunction likely is dependent on combination of parental knowledge and patient symptomatology and familiarity of symptoms in relation to previous shunt malfunction symptoms. There are currently no UK studies on accuracy of parental diagnosis of shunt malfunction. We undertook this study to investigate sensitivity and specificity of parental diagnosis in our tertiary paediatric neurosurgical unit to identify any factors that can be used for further education and raising awareness in parents with children with shunts.MethodsWe undertook a review of all referrals with suspected shunt malfunction to our tertiary paediatric neurosurgical unit over a period of 10 months. All referrals and presentations were evaluated for parental concern for likelihood of shunt malfunction and marked as yes or no. Further information gathered included demographics, age, sex, symptoms at presentation, previous history of shunt revision, cases of shunt malfunction and part of the shunt revised. Sensitivity, specificity, positive and negative predictive values and accuracy were then calculated and factors associated with positive diagnosis of shunt malfunction analysed.ResultsOverall, 100 referrals with suspected shunt malfunction were made over 10 months period. Mean age for children at the time of referral was 6.3 years with an M/F ratio of 42M:58F. Twenty-one shunt malfunction cases were identified leading to overall revision rate of 21%. Parental evaluation of shunt function had sensitivity of 90.4%, specificity of 10.1%, positive predictive value of 21.1% and negative predictive value of 80%. Drowsiness and higher number of symptoms at presentation were associated with true positive diagnosis of shunt malfunction. No link was identified with true diagnosis of shunt malfunction with other symptoms of shunt malfunction or previous history of shunt revision and age of the patient.ConclusionParental diagnosis of shunt malfunction has high sensitivity and negative predictive value and low specificity and positive predictive value. Increased number of symptoms as well as drowsiness were associated with correct parental diagnosis of shunt malfunction. Educational programs and parental training can be valuable in increasing awareness about shunt malfunction signs.
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Pais , Humanos , Masculino , Feminino , Criança , Pré-Escolar , Pais/psicologia , Adolescente , Lactente , Falha de Equipamento , Hidrocefalia/cirurgia , Derivações do Líquido Cefalorraquidiano/efeitos adversos , Estudos Retrospectivos , Sensibilidade e EspecificidadeRESUMO
AIM: Patients with a background of cerebrospinal fluid (CSF)-diverting shunts are frequently investigated for shunt malfunction when presenting with seizures. However, there is very limited evidence in the literature regarding the association of seizures and shunt malfunction. We sought to determine the incidence of shunt malfunction in our cohort of shunted paediatric patients presenting with seizures, and the utility of seizures as a marker of shunt malfunction. METHODS: We retrospectively identified all shunted patients presenting with seizures, as well as all patients undergoing shunt revision following a presentation with seizures from our hospital database over a 14-year period from 2009 to 2023. Data gathered included demographics, de novo seizures or change in pattern of seizures, the aetiology of hydrocephalus and the segment of shunt requiring revision. Exclusion criteria included infected cases requiring shunt externalisation. A literature review of all papers discussing seizures as a presentation of shunt malfunction was also carried out. RESULTS: Overall, over a 14-year period of study, 338 shunted patients presented with seizures and were referred as suspected shunt malfunction with 10 having confirmed shunt malfunction requiring revision (2.9%). This group represented 6.2% of 161 cases of shunt revision carried out during the 14-year period of study. Post-haemorrhagic hydrocephalus secondary to prematurity was the commonest aetiology of shunted hydrocephalus presenting with seizures. Out of 10 patients presenting with seizures with shunt malfunction, 4 presented with de novo seizures, while 6 presented with a change in seizure pattern or frequency in already known epileptic patients. Shunt revision surgeries included 5 distal catheter, 2 proximal catheter, 1 proximal catheter-valve, 1 valve only and 1 case of whole shunt change. CONCLUSION: Our data supports that seizures are rare manifestation of shunt malfunction and can present either de novo or with a change in seizure frequency in already-known epileptic patients.
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Derivações do Líquido Cefalorraquidiano , Falha de Equipamento , Hidrocefalia , Convulsões , Humanos , Convulsões/etiologia , Masculino , Feminino , Pré-Escolar , Criança , Estudos Retrospectivos , Lactente , Hidrocefalia/cirurgia , Derivações do Líquido Cefalorraquidiano/efeitos adversos , Adolescente , Recém-Nascido , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/epidemiologia , ReoperaçãoRESUMO
PURPOSE: Ventriculoperitoneal shunt (VPS) insertion is the gold standard treatment for congenital hydrocephalus, but there is little data about the cost of this procedure in developing countries. We aimed to determine the in-hospitalization cost of initial VPS insertion and its complications (malfunction and infection) and identify predictors of increased cost. METHODS: We performed a retrospective cohort study by reviewing the medical and financial records of pediatric patients with congenital hydrocephalus and underwent shunt surgery at our institution between 2015 and 2019. We also performed multivariable linear regression analysis to determine clinical characteristics that were predictive of cost. RESULTS: A total of 230 cerebrospinal fluid diversion procedures were performed on 125 patients. The mean age during index VPS insertion was 9.8 months (range: 7 days-8 years). Over a median follow-up of 222 days, 15 patients (12%) developed shunt malfunction while 25 (20%) had a shunt infection. The mean in-hospitalization cost for all patients was PHP 94,573.50 (USD 1815). The predictors of higher cost included shunt infection (p < 0.001), shunt malfunction (p < 0.001), pneumonia (p = 0.006), sepsis (p = 0.004), and length of hospital stay (p = 0.005). Patients complicated by shunt infection had a higher mean cost (PHP 282,631.60; USD 5425) than uncomplicated patients (PHP 40,587.20 or USD 779; p < 0.001) and patients who had shunt malfunction (PHP 87,065.70 or USD 1671; p < 0.001). CONCLUSION: The study provided current data on the in-hospitalization cost of VPS insertion in a public tertiary hospital in a developing country. Shunt infection, malfunction, pneumonia, sepsis, and length of hospital stay were significant predictors of cost.
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Ventriculoperitoneal shunt surgery was developed to manage excessive cerebrospinal fluid (CSF) in the brain's ventricles and is considered a mainstream treatment. Despite the development of the shunt device system, various complications still occur. In this study, we reported 307 cases and a long-term follow-up of at least five years of adult patients who underwent VP shunt surgery and analyzed various factors that may affect revision surgery. A retrospective study was conducted at Asan Medical Center, Korea, a tertiary medical center. We reviewed 307 cases from January 2012 to December 2018. The patients' neurological status, predisposing medical conditions, laboratory findings, and other operation-related factors were reviewed using electrical medical records. The normal function group comprised 272 cases (88.6%), and the overall incidence of revision group comprised 35 cases (11.4%). Of the 35 revision surgery cases, 30 (85.71%) were due to shunt malfunctions, such as obstruction, overdrainage, and valve-related errors while 5 (14.29%) were due to shunt infection. Patient demographics, mental status, and operation time did not influence revision as risk factors. Serum laboratory findings showed no statistical difference between the two groups. The white blood cell (WBC) count in the CSF profile differed significantly between the two groups. The Hakim Programmable valve (Codman, USA) is mainly used in our center. In addition, various shunt systems were used, including Strata Regulatory valve (Medtronic, USA), proGAV (Aesculap, USA), and Accu-Flo (Codman, USA). This study analyzed the factors affecting long-term outcomes. Based on these findings, efforts are needed to achieve more favorable outcomes in the future.
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Hidrocefalia , Derivação Ventriculoperitoneal , Humanos , Derivação Ventriculoperitoneal/efeitos adversos , Masculino , Feminino , Pessoa de Meia-Idade , Fatores de Risco , Adulto , Estudos Retrospectivos , Incidência , Idoso , Seguimentos , Hidrocefalia/cirurgia , Reoperação , Complicações Pós-Operatórias/epidemiologia , Falha de Equipamento , Adulto JovemRESUMO
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 Infusão Implantáveis , Injeções Espinhais , Relaxantes Musculares Centrais , Humanos , Baclofeno/administração & dosagem , Baclofeno/efeitos adversos , Masculino , Feminino , Pessoa de Meia-Idade , Estudos Retrospectivos , Adulto , Fatores de Risco , Bombas de Infusão Implantáveis/efeitos adversos , Relaxantes Musculares Centrais/administração & dosagem , Relaxantes Musculares Centrais/efeitos adversos , Injeções Espinhais/efeitos adversos , Idoso , Adulto Jovem , Espasticidade Muscular/tratamento farmacológico , Falha de Equipamento/estatística & dados numéricos , AdolescenteRESUMO
OBJECTIVE: Intrathecal baclofen (ITB) pumps are commonly used in pediatric patients with cerebral palsy (CP) and medically refractory spasticity. However, catheter malfunction and associated risk factors are not well understood. The aim of this study was to examine potential risk factors for spinal catheter malfunction and characterize postoperative follow-up to understand the clinical consequences. METHODS: Patients who received ITB pump replacement or revision at Boston Children's Hospital between 2010 and 2023 were retrospectively reviewed. The spinal catheter revision cohort (SCRC) included patients whose spinal catheter was occluded requiring lumbar catheter revision. The second cohort included abdominal pump replacements only (APRC). Between-group comparisons and multivariable regression identified factors associated with catheter revision and postoperative outcomes. RESULTS: Forty-one (33.6%) patients underwent spinal catheter revision and were compared with 81 patients (66.4%) who underwent abdominal pump replacement only. Younger age at surgery and an elevated preoperative lower-extremity modified Ashworth scale grade were associated with spinal catheter revision (p < 0.05). Catheter model type, tip location, and history of spinal fusion were not associated with obstruction. Postoperatively, SCRC patients experienced a higher rate of infection (17.1%) relative to APRC patients (0%) within 30 days from their ITB pump replacement procedure (p < 0.05) and greater likelihood of subsequent ITB system removal compared with the APRC (24.4% vs 7.4%, p < 0.05). Although not differing preoperatively, SCRC patients had lower postoperative ITB doses when compared with the APRC group (median dose 143 vs 350 µg/day, p < 0.05) at hospital discharge and remained statistically different at the 6-month and 1-year follow-ups (p < 0.05). There were no postoperative differences in baclofen overdose, withdrawal, or median number of hospital readmissions within 30 days. Overall, 31.7% of spinal catheter revisions were unanticipated by the clinical team at time of surgery. CONCLUSIONS: Younger age at surgery and increased preoperative lower-extremity tone may be risk factors for catheter obstruction, resulting in a higher rate of postoperative infection and subsequent ITB pump removal compared with pump replacement alone. Spinal catheter occlusion can complicate revision or replacement procedures, especially when unanticipated. Routine clinical assessment may be inadequate for diagnosing insidious catheter malfunction. Catheter occlusion deserves further study, and routine assessment of catheter patency may be warranted to prevent suboptimal tone therapy.
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Baclofeno , Paralisia Cerebral , Bombas de Infusão Implantáveis , Relaxantes Musculares Centrais , Humanos , Baclofeno/administração & dosagem , Baclofeno/efeitos adversos , Masculino , Feminino , Criança , Bombas de Infusão Implantáveis/efeitos adversos , Fatores de Risco , Relaxantes Musculares Centrais/administração & dosagem , Estudos Retrospectivos , Adolescente , Paralisia Cerebral/cirurgia , Paralisia Cerebral/complicações , Pré-Escolar , Espasticidade Muscular/tratamento farmacológico , Espasticidade Muscular/etiologia , Espasticidade Muscular/cirurgia , Reoperação/métodos , Injeções Espinhais/métodos , Resultado do Tratamento , Complicações Pós-Operatórias/etiologia , Falha de Equipamento , Estudos de CoortesRESUMO
OBJECTIVE: To investigate the feasibility and efficacy of combining ultrasound-guided sharp needle technique with percutaneous transluminal angioplasty (PTA) for treating outflow stenosis or dysfunction in arteriovenous fistula (AVF) among hemodialysis patients. METHODS: From October 2021 to March 2023, patients with occluded or malfunctional fistula veins not amenable to regularly angioplasty were retrospectively enrolled in the study. They underwent ultrasound-guided sharp needle intervention followed by PTA. Data on the location and length between the two veins, technical success, clinical outcomes, and complications were collected. Patency rates post-angioplasty were calculated through Kaplan-Meier analysis. RESULTS: A total of 23 patients were included. The mean length of the reconstructed extraluminal segment was 3.18 cm. The sharp needle opening was performed on the basilic vein (60.9%), brachial vein (26.1%), or upper arm cephalic vein (13%) to create outflow channels. Postoperatively, all cases presented with mild subcutaneous hematomas around the tunneling site and minor diffuse bleeding. The immediate patency rate for the internal fistulas was 100%, with 3-month, 6-month, and 12-month patency rates at 91.3%, 78.3%, and 43.5%, respectively. CONCLUSION: Sharp needle technology merged with PTA presents an effective and secure minimally invasive method for reconstructing the outflow tract, offering a new solution for recanalizing high-pressure or occluded fistulas.
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Derivação Arteriovenosa Cirúrgica , Diálise Renal , Ultrassonografia de Intervenção , Grau de Desobstrução Vascular , Humanos , Feminino , Masculino , Derivação Arteriovenosa Cirúrgica/efeitos adversos , Derivação Arteriovenosa Cirúrgica/métodos , Pessoa de Meia-Idade , Diálise Renal/métodos , Estudos Retrospectivos , Idoso , Adulto , Agulhas , Angioplastia/métodos , Oclusão de Enxerto Vascular/etiologia , Estudos de Viabilidade , Resultado do TratamentoRESUMO
Backgrounds: The malfunction of peritoneal dialysis (PD) catheter is still an intractable problem. A modified open surgical revision technique with suturing fixation and without catheter removal for malfunctioning catheter was developed to evaluated the efficacy and safety between simultaneous catheter replacement technique.Methods: A total of 167 PD patients with malfunctioning catheter were retrospectively reviewed. For the salvage of PD catheters, patients underwent modified open surgical revision (group A) or simultaneous catheter replacement (group B). The baseline characteristics before operation, perioperative condition, complications and outcomes were compared between both groups.Results: Patients of group A showed significantly shorter operative time (67.4 ± 22.1 versus 82.8 ± 21.1 min, p = 0.009), less postoperative pain score within 24 h (median 0.0 versus 2.0, p < 0.001), quicker start of PD (1.06 ± 0.31 versus 1.89 ± 0.89 days, p < 0.001), shorter length of stay (9.89 ± 5.11 versus 12.55 ± 7.37 days, p = 0.020) than group B. In terms of complications, the incidence of recurred catheter malfunction in group A was significantly lower than those in group B (1/114 versus 12/53, p < 0.001). There were no significant differences in mechanical complications (bloody effluent, dialysate leakage, and hernia) and early peritonitis between the groups. The group A patients had a favorable catheter survival rate compared with group B (log-rank, p = 0.004).Conclusions: Our modified open surgical revision technique is a safe, simple and fast method, and offers a better outcome with minimal risk of recurrence of catheter malfunction without additional cost and equipment. This technique is worthy of clinical application.
Assuntos
Cateteres de Demora , Falha de Equipamento , Diálise Peritoneal , Reoperação , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Estudos Retrospectivos , Diálise Peritoneal/instrumentação , Diálise Peritoneal/efeitos adversos , Cateteres de Demora/efeitos adversos , Idoso , Adulto , Remoção de Dispositivo/métodos , Falência Renal Crônica/terapia , Tempo de Internação , Resultado do Tratamento , Duração da Cirurgia , Técnicas de Sutura/instrumentaçãoRESUMO
BACKGROUND: This study aims to establish a simplified and effective animal model of catheter malfunction caused by omental wrapped using negative pressure suction. METHOD: The peritoneal dialysis catheter outlet was linked to a negative-pressure (0-75mmHg) suction pump to intensify the negative pressure. Different negative pressures were tested for model construction in vitro. In vivo, a model of peritoneal catheter malfunction caused by omental wrapped was constructed in five beagles after catheter placement. Catheter drainage conditions and related complications were monitored before and after the model establishment. RESULTS: In the vitro experiment, the overall success rate of constructed models was 90% (36/40). The total malfunction rate was higher in 62.5 mmHg (10/10) and 75 mmHg (10/10) than in 12.5 mmHg (8/10) and 37.5 mmHg (8/10). The outflow velocity of dialysate at 62.5 mmHg was significantly lower than that at 12.5 mmHg and 37.5 mmHg, without a statistically significant difference compared to 75 mmHg. In the in vivo experiment, catheter outflow velocity increased, and residual fluid volume decreased after omental wrapped (99.6 ± 6.7 ml/min vs. 32.6 ± 4.6 ml/min at initial five minutes, p < 0.0001; 69.2 ± 16.3 ml vs. 581.0 ± 109.4 ml, p < 0.001). And the outflow velocity was finally below 2 ml/min. No severe related complications (such as infection, organ damage, or bleeding) were observed through laparoscopic examination and dialysate tests seven days post-operation. CONCLUSION: Utilizing negative pressure suction to increase negative pressure around catheter tip is a simple, safe, and effective method for establishing an animal model of omental wrapped leading to catheter malfunction.
Assuntos
Falha de Equipamento , Omento , Diálise Peritoneal , Animais , Cães , Sucção/instrumentação , Diálise Peritoneal/instrumentação , Diálise Peritoneal/efeitos adversos , Cateteres de Demora/efeitos adversos , Modelos Animais de Doenças , Masculino , Modelos AnimaisRESUMO
Low-power embedded systems have been widely used in a variety of applications, allowing devices to efficiently collect and exchange data while minimizing energy consumption. However, the lack of extensive maintenance procedures designed specifically for low-power systems, coupled with constraints on anticipating faults and monitoring capacities, presents notable difficulties and intricacies in identifying failures and customized reaction mechanisms. The proposed approach seeks to address the gaps in current resource management frameworks and maintenance protocols for low-power embedded systems. Furthermore, this paper offers a trilateral framework that provides periodic prescriptions to stakeholders, a periodic control mechanism for automated actions and messages to prevent breakdowns, and a backup AI malfunction detection module to prevent the system from accessing any stress points. To evaluate the AI malfunction detection module approach, three novel autonomous embedded systems based on different ARM Cortex cores have been specifically designed and developed. Real-life results obtained from the testing of the proposed AI malfunction detection module in the developed embedded systems demonstrated outstanding performance, with metrics consistently exceeding 98%. This affirms the efficacy and reliability of the developed approach in enhancing the fault tolerance and maintenance capabilities of low-power embedded systems.