MRI in Patients with Cardiovascular Implantable Electronic Devices and Fractured or Abandoned Leads.

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.

Uncovering the rate and risk factors of intrathecal baclofen pump-associated complications in the adult population.

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.

Incidence, implications, and management of sense-B-noise failure in subcutaneous cardioverter-defibrillator patients: insights from a large multicentre registry.

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.

Occurrence of premature battery depletion in a large multicentre registry of subcutaneous cardioverter-defibrillator patients.

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.

Subcutaneous edema as a potential cause of catheter failure in older inpatients receiving peripheral parenteral nutrition.

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.

Lumbar Lordosis is a Risk Factor for Lumbar Catheter Fracture of Lumboperitoneal Shunt.

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.

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.

Comparison of outcomes from tunnelled femorally inserted central catheters and peripherally inserted central catheters: a propensity score-matched cohort study.

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.

Adverse Events and Device Failures Associated with Pancreatic Stents: A Comprehensive Analysis Using the FDA's MAUDE Database.

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.

Major Complications and Adverse Events Related to Use of SpaceOAR Hydrogel for Prostate Cancer Radiotherapy.

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.

Adverse events associated with anastomotic coupling devices in microvascular reconstruction.

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.

A comparative analysis of infection and complication rates between single- and double-lumen ports.

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.

Comparative Study of Bilateral Dual Sacral-Alar-Iliac Screws versus Bilateral Single Sacral-Alar-Iliac Screw for Adult Spine Deformities.

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.

Protective Dressings, Injury, and Device Failure in Preterm Infants Receiving Nasal Continuous Positive Airway Pressure: A Randomized Controlled Trial.

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.

Risk events during intrahospital transport of patients from the emergency department: a prospective observational study.

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.

Subcutaneous implantable cardioverter-defibrillator and defibrillation testing: A propensity-matched pilot study.

BACKGROUND: To date, only a few comparisons between subcutaneous implantable cardioverter-defibrillator (S-ICD) patients undergoing and those not undergoing defibrillation testing (DT) at implantation (DT+ vs DT-) have been reported. OBJECTIVE: The purpose of this study was to compare long-term clinical outcomes of 2 propensity-matched cohorts of DT+ and DT- patients. METHODS: Among consecutive S-ICD patients implanted across 17 centers from January 2015 to October 2020, DT- patients were 1:1 propensity-matched for baseline characteristics with DT+ patients. The primary outcome was a composite of ineffective shocks and cardiovascular mortality. Appropriate and inappropriate shock rates were deemed secondary outcomes. RESULTS: Among 1290 patients, a total of 566 propensity-matched patients (283 DT+; 283 DT-) served as study population. Over median follow-up of 25.3 months, no significant differences in primary outcome event rates were found (10 DT+ vs 14 DT-; P = .404) as well as for ineffective shocks (5 DT- vs 3 DT+; P = .725). At multivariable Cox regression analysis, DT performance was associated with a reduction of neither the primary combined outcome nor ineffective shocks at follow-up. A high PRAETORIAN score was positively associated with both the primary outcome (hazard ratio 3.976; confidence interval 1.339-11.802; P = .013) and ineffective shocks alone at follow-up (hazard ratio 19.030; confidence interval 4.752-76.203; P = .003). CONCLUSION: In 2 cohorts of strictly propensity-matched patients, DT performance was not associated with significant differences in cardiovascular mortality and ineffective shocks. The PRAETORIAN score is capable of correctly identifying a large percentage of patients at risk for ineffective shock conversion in both cohorts.

Reporting of Death in US Food and Drug Administration Medical Device Adverse Event Reports in Categories Other Than Death.

Importance: In the US, most postmarket medical device safety data are obtained through adverse event reports that are submitted to the US Food and Drug Administration (FDA)'s Manufacturer and User Facility Device Experience (MAUDE) database. Adverse event reports are classified by the reporter as injury, malfunction, death, or other. If the device may have caused or contributed to a death, or if the cause of death is unknown, the FDA requires that the adverse event be reported as a death. Objective: To determine the percentage of medical device adverse event reports submitted to the MAUDE database that were not classified as death even though the patient died. Design, Setting, and Participants: In this study, a natural language processing algorithm was applied to the MAUDE database, followed by manual text review, to identify reports in the injury, malfunction, other or missing categories that included at least 1 term that suggested a patient death, such as patient died or patient expired, from December 31, 1991, to April 30, 2020, for any medical device. Exposures: Manual review of a random sample of 1000 adverse event reports not classified as death and of selected reports for 62 terms that are associated with deaths but were not classified as death. Main Outcomes and Measures: Percentage of adverse event reports in which the patient was said to have died in the narrative section of the report but the reporter classified the report in a category other than death. Results: The terms in the natural language processing algorithm identified 290 141 reports in which a serious injury or death was reported. Of these, 151 145 (52.1%) were classified by the reporter as death and 47.9% were classified as malfunction, injury, other, or missing. For the overall sample, the percentage of reports with deaths that were not classified as deaths was 23% (95% CI, 20%-25%), suggesting that approximately 31 552 reports in our sample had deaths that were classified in other categories. The overall percentage of missed deaths, defined as the percentage of deaths that were classified in other categories, was 17% (95% CI, 16%-19%). Conclusions and Relevance: Many of the findings of this study suggest that many medical device adverse event reports in the FDA's MAUDE database that involved a patient death are classified in categories other than death. As the FDA only routinely reviews all adverse events that are reported as patient deaths, improving the accuracy of adverse event reporting may enhance patient safety.

A real-world study evaluating ultrasound-guided percutaneous non-targeted liver biopsy needle failures and pathology sample-quality assessment in both end-cut and side-notch needles.

OBJECTIVES: To determine biopsy device failures, causative factors, complications and sample quality of the 16G end-cut Biopince™ and side-notch Bard™ needles. METHODS: All ultrasound-guided non-targeted liver biopsies between 01/01/2016 and 31/12/2018 were included. Operator, device, number of failures, complications and repeat biopsies were recorded. Histopathology samples were reviewed for all cases of needle failure and a group with no failures, and graded "yes/no" for the presence of steatosis, inflammation and fibrosis. The pathology slides from these cases were reviewed to assess biopsy sample quality (length and portal tract number). The failure and no-failure groups were compared in terms of device type/histology, and sample quality was compared between the needle types. RESULTS: 1004 patients were included. 93.8% (n = 942) required one needle pass to obtain a sample and 6.2% (n = 62) required >1 pass due to needle failure. Total of 76 needle failures, more with end-cut than side-notch needles (8.7% vs 2.9%) (p < 0.001). No needle failures resulted in complication. The presence of liver fibrosis was associated with fewer needle failures (p = 0.036). The major complication rate was 0.4% (4/1044). A biopsy with >10 portal tracts was obtained in 90.2% of specimens > 20 mm long, compared with 66% of 16-20 mm biopsies and 21% of <16 mm biopsies. The target of >10 portal tracts was achieved in 10/26 (38.5%) of side-notch biopsies and 64/90 (71.1%) of end-cut biopsies (p = 0.004). CONCLUSION: Ultrasound-guided liver biopsy is safe and sample quality is consistently good when a core >20 mm long is obtained. The end-cut biopsy device generated reliably good quality biopsy samples; however, the needle failure rate was significantly higher than the side-cut needle. ADVANCES IN KNOWLEDGE: Ultrasound-guided liver biopsy specimen quality is consistently good when a core >20 mm long is obtained which can be achieved with a single pass using the 16G BiopinceTM end-cut needle, although the needle failure rate is significantly higher than the 16G Max-Core™ Bard™ side-notch needle.

Failure Rates During Reuse of Disposable N95 Masks in Clinical Practice in the Emergency Department.

INTRODUCTION: The coronavirus 2019 pandemic caused a shortage of disposable N95 respirators, prompting healthcare entities to extend the use of these masks beyond their intended single-use manufacturer recommendation with a paucity of supporting research. METHODS: We performed a prospective cohort study of ED healthcare workers (HCW) ("subjects") required to use respirators at an academic, Level I trauma center. Subjects had been previously fit tested and assigned an appropriately sized N95 mask per hospital protocol. Per study protocol, subjects were fit tested periodically throughout their shifts and on multiple shifts over the eight-week study period. Data points collected included the age of the mask, subjective assessment of mask seal quality, and fit test results. We analyzed the data using Fisher's exact test, and calculated odds ratios (OR) to determine the failure rate of disposable N95 masks following reuse. RESULTS: A total of 130 HCWs underwent fit testing and 127 were included for analysis. Mask failure rate climbed after day 2 of use, with 33.3% of masks failing at day 3, 42.9% at day 4, and 50% at ≥ day 5. Categorizing the masks into those being used for two or fewer days vs those in use for three or more, failure was more common on day 3 of use or older compared to those in the first two days of use (41.8% vs 8.3%, P < 0.0001) with an OR of failure with an older mask of 7.9 (confidence interval [CI], 2.8-22.3). The healthcare workers' assessment of poor seal was 33.3% sensitive (CI, 18.6-51.9) and 95.7% specific (CI, 88.8-98.6) for fit test failure. CONCLUSION: Disposable N95 masks have significant failure rates following reuse in clinical practice. Healthcare personnel also performed poorly in assessing the integrity of the seal of their disposable respirators.

MAUDE Database Analysis of Post-Approval Outcomes following Left Atrial Appendage Closure with the Watchman Device.

Left atrial appendage closure (LAAC) is an important strategy to reduce stroke risk in patients with non-valvular atrial fibrillation (AF) who are at high risk of bleeding on long-term anticoagulation. Real-world assessments of the safety of the Watchman LAAC device remain limited. The objective of this study was to determine the frequency and timing of adverse events associated with Watchman LAAC device implants performed after FDA approval. Adverse events associated with Watchman LAAC implants performed between March 2015 and March 2019 were identified through a search of the FDA Manufacturer and User Facility Device Experience (MAUDE) database. During the study period, 3,652 unique adverse events were identified. An estimated 43,802 Watchman implants were performed in the United States during the study period. The overall adverse event rate was 7.3% and the mortality rate was 0.4%. Of the 159 unique types of adverse events identified, pericardial effusion was most common (1.4%). Most adverse events (73%) occurred intraoperatively (59%) or within 1 day of the procedure (15%). However, 19% of deaths, 24% of strokes and 27% of device embolizations occurred >1 month after implantation. The rates of most Watchman-related adverse events reported in the MAUDE database were comparable to those observed in clinical trials. A majority of adverse events occurred within 1 day of implant. In conclusion, while the absolute event rates were low, a significant proportion of device embolizations, strokes, and deaths occurred >1 month after Watchman implant.