Peripheral intravenous catheter failure, nurse staffing levels and care complexity individual factors: A retrospective multicentre cohort study.

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.

Forensic perspectives on postmortem CIED interrogation: A systematic review and meta-analysis.

BACKGROUND: Cardiac implantable electronic devices (CIED) are a heterogeneous group of medical devices with increasingly sophisticated diagnostic capabilities, which could be exploited in forensic investigations. However, current guidelines are lacking clear recommendations on the topic. The first aim of this systematic review is to provide an updated assessment of the role of postmortem CIED interrogation, and to give practical recommendations, which can be used in daily practice. Secondly, the authors aim to determine the rates of postmortem CIED interrogation and autopsy investigations, the type of final rhythm detected close to death (with a focus on the significance of documented arrhythmias), as well as the role of postmortem CIED interrogation in the determination of final cause/time of death, and any potentially fatal device malfunctions. METHODS: A systematic search in MEDLINE and Scopus aiming to identify reports concerning postmortem human CIED interrogation was performed, including a systematic screening of reference lists. Case reports, letters to the editors, commentaries, review articles or guidelines were excluded, along with studies related to cardiac devices other than CIED. All data were pooled and analyzed using fixed-effects meta-analysis models, and the I2 statistic was used to assess heterogeneity. RESULTS: A total of 25 articles were included in the systematic review, enrolling 3194 decedent CIED carriers. Ten studies (40%) had a 100% autopsy rate, whereas in further 6 studies autopsy findings were variably reported; CIED interrogation was available from 22 studies (88%), and it was never performed prior to autopsy. The overall rate of successful postmortem CIED interrogation was 89%, with high heterogeneity among studies, mainly due to device deactivation/battery discharge. Twenty-four percent of CIED carriers experienced sudden cardiac death (SCD), whereas non-sudden cardiac and non-cardiac death (NSCD, NCD) were reported in 37% and 30% of decedents, respectively. Ventricular tachyarrhythmias were recorded in 34% of overall successfully interrogated CIED, and in 62% of decedents who experienced a SCD; of all ventricular tachyarrhythmias recorded, 40% was found in NSCD or NCD. A clear interpretation of the etiological role of recorded arrhythmias in the causation of death required integration with autopsy findings. Overall, potentially fatal device malfunctions were detected in 12% of cases. CONCLUSIONS: Postmortem CIED interrogation is a valuable tool for the determination of the cause of death, and may complement autopsy. Forensic pathologists need to know the potential utility, pitfalls, and limitations of this diagnostic examination to make this tool as much reliable as possible.

Factors influencing NiTi endodontic file separation: A thematic review.

Nickel-titanium (NiTi) file separation during endodontic treatment is an undesirable event. This phenomenon needs to be understood by knowing the factors influencing fracture in endodontic files. There is a large amount of literature where these factors and their influence have been studied, increasing the knowledge about the mechanisms involved, mainly related to wire technology, file shapes and geometry, operator manipulation, the anatomy of the root canal, and the irrigation and sterilization processes. As many factors are involved, the complexity of the fracture phenomena increases and the isolated correlation of one factor with the file fracture becomes a small part of comprehending the separation phenomena. This thematic review aims to compile important reports from 2014 to 2022 on the factors influencing NiTi file separation. The information obtained was classified into wire technology, file geometry, operational aspects, irrigation and sterilization, and anatomy. For this purpose, the Scopus, Web of Science and ScienceDirect databases were consulted using a search string. Filters were applied to consolidate the final set of relevant papers covering the subject of factors influencing endodontic file separation. It was found that the fracture of NiTi files incorporates different mechanisms that operate simultaneously during the endodontic procedure and strongly affect the instrument performance. The collected information promotes good practices to prevent file separation.

Novel Peripheral Intravenous Catheter Securement for Children and Catheter Failure Reduction: A Randomized Clinical Trial.

Importance: Peripheral intravenous catheters (PIVCs) facilitate essential treatment. Failure of these essential devices is frequent and new securement strategies may reduce failure and improve patient outcomes. Objective: To evaluate clinical effectiveness of novel PIVC securement technologies for children to reduce catheter failure. Design, Setting, and Participants: A 3-arm, parallel group, superiority randomized clinical trial was conducted at 2 regional Australian hospitals from February 5, 2020, to January 14, 2022. Children aged 6 months to 8 years who were anticipated to require admission with a PIVC for at least 24 hours of in hospital treatment were eligible. Data were analyzed from May 25, 2022, to February 20, 2024. Interventions: Participants were randomly allocated in a 1:1:1 ratio to standard care, bordered polyurethane (Tegaderm [3M]), integrated securement dressing (SorbaView SHIELD [Medline]), and integrated securement dressing with tissue adhesive (Secureport IV). One catheter was studied per patient. Main Outcomes and Measures: Primary outcome was PIVC failure, defined as premature cessation of PIVC function for any reason prior to completion of planned treatment. Secondary outcomes were PIVC complications (any time dislodgement, occlusion, infiltration, partial dislodgement, extravasation, device leaking, phlebitis, pain), PIVC longevity, intervention acceptability (clinicians, participants, caregivers; 0-10 scale), and pain on removal (participants and caregivers; 0-10 scale relevant to age), adverse events, and health care costs. Results: A total of 383 patients (51% female; median age 36 [25th-75th percentiles, 22-72] months) were randomized 134 to standard care, 118 to integrated securement dressing, and 131 to integrated securement dressing with tissue adhesive. PIVC failure was lowest in integrated securement dressing with tissue adhesive (15 [12%]; adjusted hazard ratio [aHR], 0.47; 95% CI, 0.26-0.84) compared with integrated securement dressing (24 [21%]; aHR, 0.78; 95% CI, 0.47-1.28) and standard care (43 [34%]). Direct costs were significantly lower for integrated securement dressing with tissue adhesive (median, Australian dollars [A$], 312 [A$1 is equal to $0.65 US dollars]; IQR, A$302-A$380) and integrated securement dressing (median, A$303; IQR, A$294-A$465) compared with standard care (median, A$341; IQR, A$297-A$592; P ≤ .002) when considering the economic burden related to failure of devices. PIVC longevity and intervention acceptability were similar across all groups. Conclusions and Relevance: In this study, PIVCs secured with integrated securement dressings and tissue adhesive, in comparison with standard care, bordered polyurethane dressings, were associated with significantly reduced PIVC failure, for children admitted to hospital via the emergency department. Further research should focus on implementation in inpatient units where prolonged dwell and reliable intravenous access is most needed. Trial Registration: Australian New Zealand Clinical Trials Registry Identifier: ACTRN12619001026112.

Implantable cardioverter-defibrillator lead failure and revision following transcutaneous bicaval valve (TricValve®) implantation.

INTRODUCTION: Tricuspid regurgitation is associated with significant morbidity and mortality, and occurs at a higher rate in patients with cardiovascular implantable electronic devices. Percutaneous strategies for managing tricuspid regurgitation are evolving, including the development of bicaval valve implantation which has been successfully used in patients with pacing leads. METHODS AND RESULTS: We present the first documented case of lead failure following TricValve® implantation, a dedicated self-expanding system for bicaval valve implantation, and the first successful lead revision procedure in this setting. CONCLUSION: The case illustrates important considerations in undertaking percutaneous intervention in patients with cardiovascular implantable electronic devices, and their ongoing management.

An Improvised Cost-Effective Repair Technique for Management of Broken Luer Connections of Tunneled Dialysis Catheter and Salvage Existing Catheter.

Mechanical problems like break or crack in Luer connectors or hubs, clamps, and tubings are common non-infectious complications of tunneled dialysis catheters (TDC), which may lead to other TDC complications and the need to insert a new catheter. These can be tackled using TDC repair kits or spare parts, which are often not available, resulting in the insertion of a new TDC that increases morbidity, TDC-related procedures, and healthcare costs. We discuss two cases of broken Luer connections of TDC, which were managed by exchanging the broken Luer connector of TDC with the similar Luer connector of a temporary dialysis catheter. Both the repaired TDCs are thereafter functioning well. This improvised technique provides an easy, effective, long-lasting option that salvages the existing TDC and reduces the cost factor.

Balloon rupture during transcatheter aortic valve replacement.

A distinctive complication with balloon-expandable (BE) THV platforms such as the Edwards Sapien (Edwards Lifescience) is the possibility of balloon rupture during THV deployment. Balloon rupture is a rare occurrence that can result in stroke due to fragment embolism, incomplete THV expansion, and/or vascular injury upon retrieval of the balloon. Careful evaluation of preoperative computed tomography is essential to identify high-risk cases. While annular and left ventricular outflow tract (LVOT) calcification are widely acknowledged as common risks for balloon injury, it's essential to note that balloon injury can manifest at various anatomical sites. In this review, we discuss the mechanism behind balloon rupture, methods to identify cases at a heightened risk of balloon injury, approaches to mitigate the risk of rupture, and percutaneous retrieval strategies.

Medical device report analyses from MAUDE: Device and patient outcomes, adverse events, and sex-based differential effects.

Post-market medical device-associated failures and patient problems are reported in Medical Device Reports (MDRs) to the US Food and Drug Administration. Reports are accessible through Manufacturer and User Facility Device Experience (MAUDE), a database including both required and voluntary submissions. We present an overview of >10 million MDRs received from 2011 to 2021. Approximately 92% of reporting issues represent medical device physical or functional failures, categorized from 1704 codes related to medical device integrity or function. ∼8% were coded adverse events (AEs). Patient outcomes are reported via 998 patient codes in 19 medical specialties (cardiovascular, orthopedic, etc.). ∼40% of patient reports indicated "no health consequences"; however, a small number of devices had consistently high AE reports. While overall reports did not exhibit a sex-based dichotomy, ∼9% of the reported AEs occurred more frequently in females, many of which were related to immune effects. The analyses are subject to uncertainties and potential bias based on data available and data selected for analysis. However, such an overview of post-market MDR data, not previously published, fills a gap in understanding medical device issues and patient-based outcomes related to medical device use. Trends identified may be subjects of additional hypotheses, analysis, and research.

Cardiovascular images: pacemaker-lead fracture and excessive coiling in a dog.

A seven-year-old male castrated Labrador Retriever presented emergently due to concern for pacemaker malfunction five years after successful transvenous pacemaker implantation to treat partial atrial standstill. On presentation, the dog's pulse rate was 30-50 beats per minute. An electrocardiogram showed no spontaneous atrial activity or paced ventricular activity. Pacemaker interrogation revealed an increased impedance of 7557 ohms, indicating a lead malfunction. Thoracic radiographs confirmed the lead was fractured and had excessive coiling. The transvenous pacing system was turned off, left in place, and an epicardial pacing system was implanted the following day. The dog was discharged with no perioperative complications. The dog eventually required escalated medical therapy for progressive cardiac disease and was euthanized two years after implantation of the replacement pacemaker. This manuscript illustrates a complete lead fracture and excessive lead coiling, which has not previously been detailed in veterinary medicine.

Effect of MT Technology of Heat Treatment on Reciproc: Comparison of Reciproc, Reciproc Blue, and Reciproc MT.

INTRODUCTION: This study aimed to evaluate the effects from the memory-triple (MT) heat treatment on the fatigue resistance of the Reciproc by comparison with the file systems of same geometry. METHODS: Reciproc files subjected to MT heat treatment technology were designated as Group RMT and were compared with the original Reciproc (Group REC) and Reciproc Blue (Group REB). Each NiTi file from 3 groups (n = 15) was operated reciprocally with a repetitive up-and-down movement in the curved canal with 4 mm of pecking distance inside of the simulated canal at body temperature. When each file fractured, the time until fracture was recorded. The length of the fractured fragment was measured. Fractured fragments were observed under scanning electron microscope (SEM) to evaluate the topographic features of the surface. Differential scanning calorimetry (DSC) analysis was performed to estimate phase transformation temperatures. One-way analysis of variance and Duncan post hoc comparison were applied to compare among the groups at a significance level of 95%. RESULTS: RMT showed significantly higher fracture resistance (P < .05), whereas there was no difference in fatigue resistance between REC and REB. SEM examination showed the files from the 3 groups had similar topographic features. RMT showed a peak of austenite peak (Ap) at a temperature (52°C) higher than body temperature, whereas REC and REB showed Ap at 37 and 32°C, respectively. CONCLUSIONS: Under the condition of this study, the new heat treatment technique of MT technology could enhance the fatigue fracture resistance of the reciprocating files made of M-wire and Blue-wire.

Rotational Load Fatigue Performance of an Implant System with an Internal Conical Connection and Microthreads.

PURPOSE: This in vitro study investigated the effect of implant geometry and diameter on the rotational load fatigue performance of an implant system with an internal conical connection with microthreads. MATERIALS AND METHODS: Regular (4.2 mm) and wide-diameter (4.8 mm) Astra Tech EV implants with straight (S) and conical (C) geometries were tested with their corresponding titanium abutments, comprising four test groups: 4.2-mm S (Group 1), 4.2-mm C (Group 2), 4.8-mm S (Group 3), and 4.8-mm C (Group 4). Five samples were included in each group. Customized brass implant holders and abutment holders were machined. A rotational load fatigue machine was used to apply a sinusoidally varying load to the implant-abutment interface at an angle of 45 degrees to produce an effective bending moment of 35 Ncm at a frequency of 14 Hz (air temperature: 20°C). The number of cycles to failure was recorded, with the upper limit set at 5 × 106 cycles. Results were analyzed using ANOVA. Failed samples were examined with a scanning electron microscope to evaluate the mode of failure. RESULTS: Of the 20 total samples, 2 failed, with Groups 1 and 2 each reporting one failure. Abutment and abutment screw fracture were observed in the failed sample in Group 1, while implant and abutment screw fracture occurred in the failed sample in Group 2. All wide-diameter implants ran beyond the cut-off without failure, but abutment screw loosening was noted in one sample in Group 3. No significant difference was found between implant groups of different geometries and diameters. Damage to the abutments and the implant internal surface were noted in all failed samples. CONCLUSIONS: While no significant differences were found between the test groups, failures were observed only in the regular-diameter group. The abutment and abutment screw fractured deep within the implant, and the implant fractured below the simulated bone level. These modes of failure may pose a significant clinical challenge during retrieval of these components.

In Vitro Evaluation of the Dynamic Cyclic Fatigue Resistance of a New TruNatomy Glider File after Different Cycles of Use.

INTRODUCTION: Determination of the glide path is recommended before using rotary instruments. This study aimed to evaluate the dynamic cyclic fatigue resistance of new and used glider rotary instruments in up to 6 root canals. METHODS: Seventy-two TruNatomy Glider files were used for the preparation of root canals of extracted lower molars, which were then submitted to the dynamic cyclic fatigue test carried out in a curved metallic artificial canal. The instruments were divided into 4 groups (n = 18): Control group, new instruments without any use in the root canal; Group 2U, instruments used in 2 mesial canals; Group 4U, instruments used in 4 mesial canals; Group 6U, instruments used in 6 mesial canals. The time to failure (TF) of the instrument was recorded, and the number of cycles to failure (NCF) was calculated. The data were submitted to 1-way analysis of variance and to the Games-Howell test for multiple comparisons, adopting a significance level of 5%. RESULTS: TF and NCF were significantly affected by the number of file uses. The Games-Howell test revealed that TF and NCF were significantly greater in the control group than in Group 4U. In Group 2U, TF and NCF were intermediate and not significantly different from the control group. Group 6U had significantly lower TF and NCF than all other groups. CONCLUSION: The TruNatomy Glider can be used as a glide path for up to 2 mesial canals of mandibular molars, whereas its use on 4 or 6 root canals is not suggested.

Postconception age at surgery as a predictor of ventriculoperitoneal shunt failure.

OBJECTIVE: The gold standard of pediatric hydrocephalus management is the ventriculoperitoneal (VP) shunt. However, VP shunts have high failure rates, and both young age and prematurity have been identified as potential risk factors for shunt failure, although neither variable describes total development at the time of surgery. This study aimed to further characterize age and shunt failure through the use of postconception age at surgery (PCAS) as well as investigate the 40-week PCAS threshold initially described in 1999. METHODS: A retrospective analysis was conducted on all first-time shunt placements at the authors' institution from 2010 to 2021. The National Surgical Quality Improvement Program (NSQIP) pediatric hydrocephalus dataset was used as a parallel analysis to ensure representativeness of the national pediatric hydrocephalus population. RESULTS: In the institutional cohort, infants with a PCAS < 40 weeks exhibited 2.4 times greater odds of shunt failure than those with a PCAS ≥ 40 weeks. In the NSQIP dataset, infants with a PCAS < 40 weeks had 1.45 times greater odds of shunt failure compared with those with a PCAS ≥ 40 weeks. CONCLUSIONS: The 40-week PCAS threshold appears to be a significant predictor of shunt failure in pediatric patients with hydrocephalus. This finding underscores the importance of considering the developmental stage at the time of surgery, rather than just prematurity status, when assessing shunt failure risk.

Tough balloon with a vulnerable shaft: an unexpected device failure.

A 73-year-old man, with a previous long drug-eluting stent (DES) from the mid-portion of the left main stem artery (LMS) to proximal left anterior descending artery (LAD), underwent elective coronary angiogram due to worsening anginal symptoms and an abnormal myocardial perfusion single photon emission computed tomography (SPECT) showing ischemia in the LAD territory.

Impact of Angle of File Access and Location of Canal Curvature on the Dynamic Cyclic Fatigue of Nickel Titanium Rotary Instruments.

OBJECTIVE: To evaluate the impact of different file access angles and root canal curvature's location on the fatigue failure of One Curve (OC) and E3 Azure (EZ) NiTi files using a dynamic model at simulated body temperature. METHODS: Eighty new instruments with similar tip sizes and taper (#25/0.06) from two NiTi rotary systems, One Curve and E3 Azure, were tested at simulated body temperatures (37°C) using a custom-made dynamic cyclic fatigue device. Instruments were divided into four subgroups according to the location of root canal curvature (a coronal curve 5 mm from the root canal orifice and an apical curve 10 mm from the root canal orifice) and the angle of file access (0° or 30°). Instruments were operated in simulated stainless-steel canals having a 60° curve and a 3 mm radius. A custom-made device produced controlled vertical pecks during file rotation. Time to failure (sec) was registered, and the length of the fragment segments was measured (mm). Data were analysed statistically with One-Way ANOVA and Tukey post hoc tests. The significance level was set at 5%. All separated instruments were examined by scanning electron microscope. RESULTS: One-way ANOVA (p<0.05) found a significant difference among the tested instruments. Post Hoc analysis revealed lower cyclic fatigue resistance when the angle of file access was 30º, and the root canal curvature was located coronally for both files (p<0.0001). Three-way ANOVA showed that the angle of file access was the most influential contributor to cyclic fatigue, followed by the location of file curvature and, finally, the file type (p<0.0001). The fractographic examination revealed a predominantly ductile fracture mode for all tested instruments. The lengths of all fractured segments showed no significant difference (p>0.05), indicating an accurate trajectory during testing. CONCLUSION: OC files had superior cyclic fatigue resistance than EZ files; coronal curvatures negatively impacted cyclic fatigue resistance compared to apical curvatures, while the angle of file access presented the highest impact on dynamic cyclic fatigue.

Evaluation of Machine Translation Accuracy Focused on the Adverse Event Terminology for Medical Devices.

The purpose of this study was to evaluate the accuracy of deep neural machine translation focused on medical device adverse event terminology. 10 models were obtained, and their English-to-Japanese translation accuracy was evaluated using quantitative and qualitative measures. No significant difference was found in the quantitative index except for a few pairs. In the qualitative evaluation, there was a significant difference and googletrans and GPT-3 were regarded as useful models.