Device Removal Research Articles

Using Papaya as a simulation based training tool to develop competency in IUCD insertion & removal in interns - Perspective of teachers and students

As per MCI’s new curriculum, insertion & removal of Intrauterine contraceptive device (IUCD) is a competency to be acquired by an Indian Medical Graduate. Only few students get the opportunity to learn this skill in a real patient. Simulation based teaching could improve the opportunity to learn. Hence we have done this study to use papaya as a cost effective simulation model for teaching IUCD insertion & removal.Institutional ethical committee approval was obtained and a workshop was conducted to all the 158 interns of Government Thoothukudi Medical College in groups of ten. Briefing and demonstration was done with an IUCD simulator. Then the students were given an opportunity to practice the procedure in papaya individually. Feedback was obtained from interns and teachers by a structured questionnaire and analyzed. The feedback was analyzed to assess the reaction, knowledge, fidelity and transfer of the knowledge by students and teachers. Skill developmentby the students before and after the training showed a significant rise (p < 0.05)This hands-on training on IUCD insertion & removal using papaya is found to have high fidelity and is very useful for the students to acquire knowledge and skill and is also approved and appreciated by the teaching faculty. Hence this can be included regularly in the teaching schedule for final year students and in Intern orientation programs.

Cardiac device-related infective endocarditis need for lead extraction whatever the device according to the ESC EORP EURO-ENDO registry.

Cardiac device-related infective endocarditis (CDRIE) is a severe complication of cardiac device (CD) implantation and is usually treated by antibiotic therapy and percutaneous device extraction. Few studies report the management and prognosis of CDRIE in real life. In particular, the rate of device extraction in clinical practice and the management of patients with left heart infective endocarditis (LHIE) and an apparently non-infected CD (LHIE+CDRIE-) are not well described. We sought to study in EURO-ENDO, the characteristics, prognosis, and management of 483 patients with a CD included in the European Society of Cardiology EurObservational Research Programme EURO-ENDO registry. Three populations were compared: 280 isolated CDRIE (66.7 ± 14.3 years), 157 patients with LHIE and an apparently non-infected CD (LHIE+CDRIE-) (71.1 ± 13.6), and 46 patients with both LHIE and CDRIE (LHIE+CDRIE+) (70.2 ± 10.1). Echocardiography was not always transoesophageal echography (TOE); it was transthoracic echography (TTE) for isolated CDRIE in 88.4% (TOE = 67.6%), for LHIE+CDRIE- TTE = 93.0% (TOE = 58.6%), and for CDRIE+LHIE+ TTE = 87.0% (TOE = 63.0%). Nuclear imaging was performed in 135 patients (positive for 75.6%). In-hospital mortality was lower in isolated CDRIE 13.2% vs. 22.3% and 30.4% for LHIE+CDRIE- and LHIE+CDRIE+ (P = 0004). Device extraction was performed in 62.1% patients with isolated CDRIE, 10.2% of LHIE+CDRIE- patients, and 45.7% of CDRIE+LHIE+ patients. Device extraction was associated with a better prognosis [hazard ratio 0.59 (0.40-0.87), P = 0.0068] even in the LHIE+CDRIE- group (P = 0.047). Prognosis of endocarditis in patients with a CD remains poor, particularly in the presence of an associated LHIE. Although recommended by guidelines, device extraction is not always performed. Device removal was associated with better prognosis, even in the LHIE+CDRIE- group.

Pediatric vagal nerve stimulator explantation: A comprehensive literature review and tertiary care experience.

Patients with medically-refractory epilepsy who undergo vagal nerve stimulator (VNS) implantation to reduce seizure burden sometimes require device removal. Complete explantation refers to the removal of both the generator and vagal nerve leads, and is uncommonly performed by otolaryngologists due to the perceived risk associated with lead removal. This comprehensive literature review and case series studies safety outcomes among pediatric patients undergoing complete VNS explantation. Literature review and tertiary care case series. PubMed, Embase, Web of Science, and Google Scholar were searched to identify all articles involving VNS explantation prior to January 2023. A retrospective review of pediatric patients undergoing complete VNS explantation from 2009 to 2023at our tertiary center was also conducted. After screening, 36 articles were retained involving 399 patients (139 confirmed children) who underwent complete VNS explantation. 26 patients (6.5%) experienced 1+ peri/post-operative complications. These included temporary VF paresis or dysphonia (n=14; 3.6%), permanent vocal fold (VF) paralysis/paresis (n=6; 1.5%), internal jugular vein injury (n=4; 1.0%), temporary dysphagia (n=2; 0.50%), and cable-bowstring phenomenon (n=1; 0.25%). Data from our tertiary care center revealed eight patients (6M: 2F) with a mean age of 11.4±6.2 years. Devices were removed for clinical ineffectiveness (n=2), infection (n=2), lead failures (n=2), and increased lead impedance (n=2). Mean total length of implantation was 44.4±40.3 months. Mean follow-up was 44.8±35.2 months. No complications were identified. Complete VNS device removal in pediatric patients is technically feasible with low reported complications. Working alongside neurosurgery, otolaryngologists offer unique expertise in dissection along the vagus nerve and may thus add value to the practice of VNS surgery.

Comparison of the Efficacy and Safety of the FDA-approved Intragastric Balloon Systems in a Clinical Setting.

The gas-filled intragastric balloon (IGB) system (Obalon) and the fluid-filled IGB system (Orbera) are the current FDA-approved IGB systems to treat obesity; however, they have not been previously compared in clinical practice. The aims of this study were to compare their efficacy, tolerance, and safety in a clinical setting. This is a retrospective cohort study of consecutive patients treated with the gas-filled IGB or fluid-filled IGB between October 2015 and May 2020 at 2 academic centers. The primary endpoints included percent total body weight loss at balloon removal in patients who completed at least 20 weeks of therapy, the difference in adverse events that required urgent evaluation or hospitalization, and early removal in the 2 groups. A total of 87 patients underwent successful IGB placement (gas-filled IGB n=57, age 48.9±8.8, body mass index 35.5±5 kg/m2; fluid-filled IGB n=30, age 49.2±14.3, body mass index 38.8±6 kg/m2). Eleven patients underwent early device removal. There were no differences in percent total body weight loss at balloon removal and 12 months between the balloon systems (P=0.39). Patients who received the fluid-filled IGB were more likely to require urgent evaluation or treatment, require hospital stay >24 hours, and need early balloon system removal compared with patients treated with the gas-filled IGB. In this 2-center cohort, both FDA-approved gastric balloon systems had the same effectiveness, but the gas-filled IGB had fewer serious adverse events and better tolerability than the fluid-filled IGB.

Complicated Pocket Infection in Patients Undergoing Lead Extraction: Characteristics and Outcomes.

Cardiac implantable electronic device (CIED) infection can present with pocket or systemic manifestations, both necessitating complete device removal and pathogen-directed antimicrobial therapy. Here, we aim to characterize those presenting with both pocket and systemic infection. A retrospective analysis of CIED extraction procedures included 300 patients divided into isolated pocket (n = 104, 34.7%), complicated pocket (n = 54, 18%), and systemic infection (n = 142, 47.3%) groups. The systemic and complicated pocket groups frequently presented with leukocytosis and fever > 37.8, as opposed to the isolated pocket group. Staphylococcus aureus was the most common pathogen in the systemic and complicated pocket groups (43.7% and 31.5%, respectively), while Coagulase-negative staphylococci (CONS) predominated (31.7%) in the isolated pocket group (10.6%, p < 0.001). No differences were observed in procedural success or complications rates. Kaplan-Meier survival analysis found that at three years of follow-up, the rate of all-cause mortality was significantly higher among patients with systemic infection compared to both pocket groups (p < 0.001), with the curves diverging at thirty days. In this study, we characterize a new entity of complicated pocket infection. Despite the systemic pattern of infection, their prognosis is similar to isolated pocket infection. We suggest that this special category be presented separately in future publications of CIED infections.

Classification of Free-Living Body Posture with ECG Patch Accelerometers: Application to the Multicenter AIDS Cohort Study.

As health studies increasingly monitor free-living heart performance via ECG patches with accelerometers, researchers will seek to investigate cardio-electrical responses to physical activity and sedentary behavior, increasing demand for fast, scalable methods to process accelerometer data. We extend a posture classification algorithm for accelerometers in ECG patches when researchers do not have ground-truth labels or other reference measurements (i.e., upright measurement). Men living with and without HIV in the Multicenter AIDS Cohort study wore the Zio XT® for up to two weeks (n = 1,250). Our novel extensions for posture classification include (1) estimation of an upright posture for each individual without a reference upright measurement; (2) correction of the upright estimate for device removal and re-positioning using novel spherical change-point detection; and (3) classification of upright and recumbent periods using a clustering and voting process rather than a simple inclination threshold used in other algorithms. As no posture labels exist in the free-living environment, we perform numerous sensitivity analyses and evaluate the algorithm against labelled data from the Towson Accelerometer Study, where participants wore accelerometers at the waist. On average, 87.1% of participants were recumbent at 4am and 15.5% were recumbent at 1pm. Participants were recumbent 54 minutes longer on weekends compared to weekdays. Performance was good in comparison to labelled data in a separate, controlled setting (accuracy = 96.0%, sensitivity = 97.5%, specificity = 95.9%). Posture may be classified in the free-living environment from accelerometers in ECG patches even without measuring a standard upright position. Furthermore, algorithms that fail to account for individuals who rotate and re-attach the accelerometer may fail in the free-living environment.

Herniation of intervertebral disc into thoracolumbar fracture vertebral body leads to malunion of fracture and decrease of intervertebral space height

To analyze the clinical characteristics of intervertebral disc tissue injury and herniation into the vertebral body in thoracolumbar fracture on fracture healing, vertebral bone defect volume and intervertebral space height. From April 2016 to April 2020, a total of 140 patients with thoracolumbar single vertebral fracture combined with upper intervertebral disc injury treated with pedicle screw rod system reduction and internal fixation in our hospital. There were 83 males and 57 females, aged from 19 to 58 years old, with an average age of (39.33±10.26) years old. All patients were followed up regularly 6 months, 12 months and 18 months after surgery. The patients with injured intervertebral disc tissue not herniated into the fractured vertebral body were the control group, and the patients with injured intervertebral disc and herniated into the fractured vertebral body were the observation group. By detecting the thoracolumbar AP and lateral X-ray films, CT and MRI of the thoracolumbar segment at different follow-up time, calculate the changes of the wedge angle of the fractured vertebral body, the sagittal kyphosis angle and the height of the superior adjacent intervertebral space, the changes of the fracture healing and bone defect volume after the reduction of the vertebral body, and the changes of the intervertebral disc degeneration grade. The prognosis was evaluated by visual analogue scale(VAS) and Oswestry disability index(ODI). Finally, the differences of the above results among different groups were comprehensively analyzed. All the patients had normal wound healing without complications. A total of 87 patients received complete follow-up data, at least 18 months after internal fixation. Thoracolumbar AP and lateral X-ray films showed that 18 months after the reduction and internal fixation operation, the vertebral wedge angle, sagittal kyphosis angle and the height of the upper adjacent intervertebral space in the observation group were greater than those in the control group(P<0.05). CT scanning showed that the deformity of the fracture healed 12 months after the vertebral body reduction in the observation group and formed a "cavity" of bone defect connected with the intervertebral space, and its volume was significantly increased compared with that before (P<0.05). MRI scanning showed that the degeneration rate of injured intervertebral discs in the observation group was more serious than that in the control group 12 months after operation(P<0.05). However, there was no significant difference in VAS and ODI score at each time. Herniation of injured intervertebral disc tissue hernias into the fractured vertebral body leads to increased bone resorption defect volume around the fracture and forms a malunion "cavity" connected with the intervertebral space. This may be the main reason for the change of vertebral wedge angle, the increase of sagittal kyphosis angle and the decrease of intervertebral space height after removal of internal fixation devices.

Need for frequent dilations after magnetic sphincter augmentation: an assessment of associated factors and outcomes.

Dysphagia is the most common complaint after magnetic sphincter augmentation (MSA), with nearly one-third of patients requiring at least one dilation following MSA. A subset of patients require frequent dilations, but there is a paucity of data on the characteristics of this population. This study aimed to identify predictors of the need for frequent dilations within the first year after implant and to assess these patients' outcomes. This is a retrospective review of prospectively collected data of patients who underwent MSA over an 8-year period. Frequent dilations were defined as 2 or more dilations within 1year of surgery. Patients completed baseline and 1-year postoperative GERD-HRQL questionnaires and objective physiology testing. Baseline demographic, clinical characteristics, and objective testing data were compared between patients who did and did not require frequent dilations. A total of 697 (62.7% female) patients underwent MSA, with 62 (8.9%) patients requiring frequent dilation. At a mean (SD) of 12.3 (3.4) months follow-up, the frequent dilation group had higher median GERD-HRQL total scores (21.0 vs. 5.0, p < 0.001), PPI use (20.8% vs.10.1%, p = 0.023), dissatisfaction (46.7% vs. 11.6%, p < 0.001), and device removal (25.8% vs. 2.2%, p < 0.001) rates. Acid normalization was comparable (p = 0.997). Independent predictors of frequent dilation included preoperative odynophagia (OR 2.85; p = 0.001), IRP > 15mmHg (OR 2.88; p = 0.006), and > 30% incomplete bolus clearance (OR 1.94; p = 0.004). At a mean (SD) of 15.7 (10.7) months, 28 (45.1%) patients underwent device removal after frequent dilation. Independent predictors of device removal after frequent dilation within 5years of surgery were preoperative odynophagia (OR 7.18; p = 0.042), LES resting pressure > 45mmHg (OR 28.5; p = 0.005), and ≥ 10% failed swallows (OR 23.5; p < 0.001). The need for frequent dilations after MSA is a marker for poor symptom control, dissatisfaction, and device removal. Patients with preoperative odynophagia, high LES pressures, and poor esophageal motility should be counseled of their risk for these poor outcomes.

GnRH34 with or without estradiol cypionate in timed AI in Bos indicus beef cows

Two experiments were performed to evaluate the effects of GnRH treatment on the fertility of suckled Nelore beef cows treated with an estradiol/progesterone (E2/P4)-based protocol for timed artificial insemination (TAI). Experiment 1 focused on determining the effects of estradiol cypionate (EC) on ovulation in TAI cows treated with GnRH 34 h after removal of the intravaginal P4 device (IPD). Suckled cows (n = 26) were treated with 2 mg estradiol benzoate (EB) and IPD containing 1 g P4. After 8 days, IPDs were removed, and all cows were treated with 150 μg of d-cloprostenol (prostaglandin F2 alpha analog) and 300 IU of equine chorionic gonadotropin (eCG), then separated into two treatment groups consisting of cows who received 1) saline 0.9% i.m. (GnRH34 group) or 2) 0.6 mg i.m. of EC (EC-GnRH34 group). On day 9 (05:00 p.m.), all cows were given GnRH (10.5 μg of buserelin acetate) i.m. No differences were observed between the groups (P > 0.05) in the time of ovulation after IPD removal or in the proportion of cows ovulating. Experiment 2 focused on determining the effects of GnRH34 along with or in the absence of EC on day 8 on pregnancy per AI (P/AI) in postpartum beef cows. Cows (n = 981) were treated similarly to those in Experiment 1, but an additional group, the EC-GnRH48 group, was included, in which cows received EC on day 8 whereas those that did not show estrus received GnRH at TAI. Thus, in this experiment, groups consisted of GnRH34 (n = 322), EC-GnRH34 (n = 335), and EC-GnRH48 (n = 324). A higher rate of estrus expression was observed in cows treated with EC following IPD removal (EC-GnRH34: 69%, EC-GnRH48: 64.8%) than in cows in the GnRH34 group (45.6%). No difference in P/AI was observed between the treatment groups (P = 0.45), but P/AI in cows in the EC-GnRH34 group (64.2%) tended to be greater (P = 0.1) than in cows in the GnRH34 group (58%). In summary, although ovulation synchrony did not differ among the groups, P/AI in cows treated with EC and GnRH 34 h after IPD removal tended to be greater than in cows treated solely with GnRH; this was most likely due to a shorter proestrus/estrus period, considering the lower proportion of cows that displayed estrus in the GnRH34 group. Finally, given that P/AI did not differ between the EC-GnRH34 and EC-GnRH48 groups, our results suggest that, for cows not displaying estrus, administration of EC at the time of IPD removal followed by treatment with GnRH 48 h afterward represents the most cost-efficient TAI strategy for South American Zebu-based beef operations.

Transvenous Lead Extraction: Work in Progress.

Cardiac implantable electronic devices are the cornerstone of cardiac rhythm management, with a significant number of implantations annually. A rising prevalence of cardiac implantable electronic devices coupled with widening indications for device removal has fuelled a demand for transvenous lead extraction (TLE). With advancement of tools and techniques, the safety and efficacy profile of TLE has significantly improved since its inception. Despite these advances, TLE continues to carry risk of significant complications, including a superior vena cava injury and mortality. However, innovative approaches to lead extraction, including the use of the jugular and femoral accesses, offers potential for further gains in safety and efficacy. In this review, the indications and risks of TLE are discussed while examining the evolution of this procedure from simple traction to advanced methodologies, which have contributed to a significant improvement in safety and efficacy.

Reevaluación del diagnóstico y el tratamiento de las infecciones de dispositivos de electroestimulación cardiaca mediante [18F]FDG-PET/TC

Introduction and objectivesThe role of [18F]FDG-PET/CT in cardiac implantable electronic device (CIED) infections requires better evaluation, especially in the diagnosis of systemic infections. We aimed to determine the following: a) the diagnostic accuracy of [18F]FDG-PET/CT in each CIED topographical region, b) the added value of [18F]FDG-PET/CT over transesophageal echocardiography (TEE) in diagnosing systemic infections, c) spleen and bone marrow uptake in differentiating isolated local infections from systemic infections, and d) the potential application of [18F]FDG-PET/CT in follow-up. MethodsRetrospective single-center study including 54 cases and 54 controls from 2014 to 2021. The Primary endpoint was the diagnostic yield of [18F]FDG-PET/CT in each topographical CIED region. Secondary analyses described the performance of [18F]FDG-PET/CT compared with that of TEE in systemic infections, bone marrow and spleen uptake in systemic and isolated local infections, and the potential application of [18F]FDG-PET/CT in guiding cessation of chronic antibiotic suppression when completed device removal is not performed. ResultsWe analyzed 13 (24%) isolated local infections and 41 (76%) systemic infections. Overall, the specificity of [18F]FDG-PET/CT was 100% and sensitivity 85% (79% pocket, 57% subcutaneous lead, 22% endovascular lead, 10% intracardiac lead). When combined with TEE, [18F]FDG-PET/CT increased definite diagnosis o fsystemic infections from 34% to 56% (P=.04). Systemic infections with bacteremia showed higher spleen (P=.05) and bone marrow metabolism (P=.04) than local infections. Thirteen patients without complete device removal underwent a follow-up [18F]FDG-PET/CT, with no relapses after discontinuation of chronic antibiotic suppression in 6 cases with negative follow-up [18F]FDG-PET/CT. ConclusionsThe sensitivity of [18F]FDG-PET/CT for evaluating CIED infections was high in local infections but much lower in systemic infections. However, accuracy increased when [18F]FDG-PET/CT was combined with TEE in endovascular lead bacteremic infection. Spleen and bone marrow hypermetabolism could differentiate bacteremic systemic infection from local infection. Although further prospective studies are needed, follow-up [18F]FDG-PET/CT could play a potential role in the management of chronic antibiotic suppression therapy when complete device removal is unachievable.

Candidemia in Patients With Cardiovascular Implantable Electronic Devices: Uncertainty in Management Based on Current International Guidelines.

In contrast to bloodstream infection due to a variety of bacteria in patients with cardiovascular implantable electronic devices (CIED), there are limited data regarding candidemia and risk of CIED infection. All patients with candidemia and a CIED at Mayo Clinic Rochester between 2012 and 2019 were reviewed. Cardiovascular implantable electronic device infection was defined by (1) clinical signs of pocket site infection or (2) echocardiographic evidence of lead vegetations. A total of 23 patients with candidemia had underlying CIED; 9 (39.1%) cases were community onset. None of the patients had pocket site infection. The duration between CIED placement and candidemia was prolonged (median 3.5 years; interquartile range, 2.0-6.5). Only 7 (30.4%) patients underwent transesophageal echocardiography and 2 of 7 (28.6%) had lead masses. Only the 2 patients with lead masses underwent CIED extraction, but device cultures were negative for Candida species. Two (33.3%) of 6 other patients who were managed as candidemia without device infection subsequently developed relapsing candidemia. Cardiovascular implantable electronic device removal was done in both patients and device cultures grew Candida species. Although 17.4% of patients were ultimately confirmed to have CIED infection, CIED infection status was undefined in 52.2%. Overall, 17 (73.9%) patients died within 90 days of diagnosis of candidemia. Although current international guidelines recommend CIED removal in patients with candidemia, the optimal management strategy remains undefined. This is problematic because candidemia alone is associated with increased morbidity and mortality as seen in this cohort. Moreover, inappropriate device removal or retention can both result in increased patient morbidity and mortality.

Management of Cardiac Implantable Electronic Devices removal with cardiopulmonary bypass: A single center experience

Backround: Currently, permanent pacemakers and internal defibrillators are widely used as a result of technological developments. Infection and dysfunction are the most important reasons for removing these devices from patients. Transvenous removal of these devices is the first recommended method. Failure of transvenous methods, presence of endocarditis, large vegetation or thrombus requires the use of surgical methods to remove these devices.&#x0D; In this study, our purpose is to present our management in surgical removal of cardiac implantable electronic devices (CIED).&#x0D; Methods: Between June 2017 and October 2019, 667 CIED were implanted and 10 patients underwent surgical removal of CIED in our hospital. The demographic data of the patients were obtained from the polyclinic files and the hospital registration system.&#x0D; Results: Eight (80%) patients were male and the mean age was 55.3±16.4 years (22.0-77.0). Complete pacemaker system removal was decided by the heart team in all cases. In 4 patients, permanent pacemaker reimplantation was required intraoperatively.&#x0D; Conclusion: CIED infection is a serious disease associated with high mortality. For this reason, we believe that it should be beneficial to consider the long-term results in determining permanent pacemaker and internal defibrillator indications.

Outpatient PureWick™ female external catheter system performance: Healthy volunteer study

Objectives:The PureWick™ female external catheter provides a non-invasive method to manage female urinary incontinence, measure urinary output, and reduce skin breakdown from urinary incontinence. This study seeks to expand the limited clinical evidence of the PureWick™ System in a non-acute setting by evaluating the efficacy of self-placement compared with healthcare provider placement, comfort, and ease of use in the outpatient community setting. If the performance of the PureWick™ System is comparable to healthcare provider placement when used in a non-acute setting and placed by the participant, further research is needed to understand the benefits and risks of medical use of the PureWick™ System used in the home when absent from supervised medical care. Study Design:Prospective, single-center, non-randomized quasi-experimental healthy volunteer study. Methods:71 healthy, female volunteers were divided into cohorts based on body mass index (BMI) and performed two supervised, independent, supine voids. The first void was into a PureWick™ System placed by a healthcare provider followed by a void with independent participant placement after viewing of an instructional video. Outcome parameters included percent of void captured, comfort, and ease of use using a 5-point Likert scale. Adverse events were also collected. Descriptive analyses were conducted for all study variables. Results:Median capture rate was over 95% for healthcare provider-placed devices and over 98% for self-placed devices, regardless of BMI. Overall, 84.5% of participants rated the device as either “comfortable” or “very comfortable”. Device placement was rated “very easy” by 95.7% of healthcare providers and “very easy” or “somewhat easy” by 95.7% of participants. Device removal was rated “very easy” by 100% of healthcare providers and over 90% of participants in all cohorts. Conclusions:Healthy volunteers found the PureWick™ comfortable and easy to use for self-placement. The comparable performance of the PureWick™ System, when used in a non-acute setting and placed by the participant, may help to expand the limited clinical evidence of the PureWick™ System in a non-acute setting.

A single dose of FSH or hCG during a split-time AI program did not enhance follicular growth or pregnancy per artificial insemination in beef heifers

ABSTRACT The objective of this study was to evaluate the effect of a low dose of hCG or FSH on follicle growth and pregnancy per artificial insemination (AI) in crossbreed beef heifers subjected to a split-time AI program. All heifers (n = 386) were subjected to a 7-d Co-synch protocol and an intravaginal controlled internal drug release (CIDR) device (GnRH and CIDR insertion; 7 days later PGF2α, CIDR removal, and application of a tail head estrus detection patch; 36 hours later AI of heifers detected in estrus, 24 hours later timed AI of remaining heifers). At CIDR removal, heifers were randomly assigned to receive either 150 IU of hCG, 20 mg of FSH, or remained as untreated controls. The diameter of the preovulatory follicle and the pregnancy per AI did not differ among treatments. A smaller (P = 0.035) proportion of heifers in the hCG group were detected in estrus compared with control. Additionally, the incidence of premature ovulation was greater (P < 0.01) among heifers treated with hCG compared with control. In conclusion, using a low dosage of hCG or FSH at the time of device removal did not affect pre-ovulatory follicle growth or the proportion of pregnant heifers.

Fluorescent-based biodegradable microneedle sensor array for tether-free continuous glucose monitoring with smartphone application.

Continuous glucose monitoring (CGM) allows patients with diabetes to manage critical disease effectively and autonomously and prevent exacerbation. A painless, wireless, compact, and minimally invasive device that can provide CGM is essential for monitoring the health conditions of freely moving patients with diabetes. Here, we propose a glucose-responsive fluorescence-based highly sensitive biodegradable microneedle CGM system. These ultrathin and ultralight microneedle sensor arrays continuously and precisely monitored glucose concentration in the interstitial fluid with minimally invasive, pain-free, wound-free, and skin inflammation-free outcomes at various locations and thicknesses of the skin. Bioresorbability in the body without a need for device removal after use was a key characteristic of the microneedle glucose sensor. We demonstrated the potential long-term use of the bioresorbable device by applying the tether-free CGM system, thus confirming the successful detection of glucose levels based on changes in fluorescence intensity. In addition, this microneedle glucose sensor with a user-friendly designed home diagnosis system using mobile applications and portable accessories offers an advance in CGM and its applicability to other bioresorbable, wearable, and implantable monitoring device technology.

CARC1: Impella 5.5 Percutaneous Left Ventricular Assist Device (LVAD) Bridge to Orthotopic Heart Transplant (OHT): A Case Series

Background: Limited donor organ availability necessitates the use of mechanical circulatory support (MCS) as a bridge to transplant for patients in medically refractory end-stage heart failure. The increasing availability, flow capability and durability of the Impella 5.5 percutaneous LVAD has benefitted patients with its minimally invasive nature. We present a single-center case series of patients supported with Impella 5.5 to OHT, demonstrating the safety and feasibility of this approach in what is, to our knowledge, the largest reported series to date. Methods: From January 2021 to present, 31 consecutive patients supported by Impella 5.5 underwent OHT at our institution. Demographic data, etiology of illness, details of procedures, duration of support, postoperative complications, and outcomes were analyzed. We additionally report two different methods of complete device removal during OHT – via device transection in the field versus removal from the axillary insertion site. Results: Of 31 patients, 80.7% (25/31) were male and the average age was 49.5 (21-70) years. The etiology of cardiomyopathy was predominantly nonischemic in 77.4% (24/31) of patients. Average length of stay was 78.2 days (27-229) with an average 53.1 days (19-133) in the intensive care unit. 27 patients (87.1%) had device placed in the right axillary artery, with 3 being on the left. Average Impella 5.5 duration was 29.6 days (2-97). During OHT, 67.7% (21/31) had device transected in the aorta and sent off the field, while the remaining 32.3% had device removal via axillary site. 8 patients (25.8%) underwent multiple organ transplant (7 kidney, 1 liver). Two patients (6.5%) suffered neurological insult. Notably, in both cases, the device was removed via the second method. There was 1 vascular complication, requiring axillary artery repair. Three patients (9.7%) had postoperative acute kidney injury or renal failure. Average days from OHT to discharge were 26.0 (7-80). There was 1 death in a patient who developed mixed septic and cardiogenic shock, and another death in a patient who developed a mediastinal infection several months postoperatively. The 30-day survival rate was 96.8% (30/31). 6.5% (2/31) patients had concern for rejection. Eleven patients (35.5%) were alive at 1 year, while another 18 (58.0%) were alive but had not yet reached 1 year post-transplant. Conclusion: Based on our institutional experience, Impella 5.5 is safe and reliable for prolonged bridge to OHT, as demonstrated in the high 30-day and 1-year survival rates. Complication rates were relatively low while offering a minimally invasive approach and avoiding resternotomy at time of OHT. We speculate that device removal via transection in the ascending aorta poses a lower stroke risk than the more established alternative, but further work will need to demonstrate superiority of either technique. Finally, further studies are needed urgently to determine the optimal MCS approach in patients awaiting OHT. Table 1. Prolonged Impella 5.5 Support as Bridge to Transplant

Weight Loss Success With Repeat Intragastric Balloon Placement After Hyperinflation and Removal of the Index Balloon

ABSTRACT Intragastric balloons are an increasingly common endoscopic alternative to bariatric surgery for the treatment of obesity. Hyperinflation is a rare complication that presents as acute-onset epigastric pain, nausea, vomiting, early satiety, abdominal distention or bloating, and rapid weight loss. Hyperinflation requires prompt diagnosis and removal of the balloon to prevent complications including gastric outlet obstruction or gastric perforation. We present a case of intragastric balloon hyperinflation with removal of the index device, followed by replacement with a second balloon, resulting in continued weight loss without further adverse events.

P98: Hemodynamic Effects of Minimally Invasive Mechanical Circulatory Support – Impella 5.5 versus Intra-Aortic Balloon Pump

Background: While the hemodynamic benefits of durable LVADs and intra-aortic balloon pumps (IABPs) in patients with acute-on-chronic heart failure are well described, the hemodynamic effects of the minimally-invasive Impella 5.5 in this patient population are not. Methods: Patient and hemodynamic data on all Impella 5.5 and IABP recipients between August 2020-November 2022 were extracted from a single-institutional database. Only patients with a history of decompensated chronic congestive heart failure were included. Patients requiring Impella support after myocardial infarction or immediately after cardiac surgery were excluded. The primary outcome was survival at 30 days after implantation. Secondary outcomes included changes in pulmonary vascular resistance (PVR), pulmonary capillary wedge pressure (PCWP), and cardiac index (CI) between device implantation and removal. Results: We identified 25 Impella 5.5 patients (12.0% female), 68 IABP patients (19.1% female), and 21 patients who had IABP exchanged for Impella 5.5 (14.2% female). There were no significant differences in baseline characteristics or hemodynamics between Impella 5.5 and isolated IABP patients (Table). Median support duration was significantly longer in the Impella 5.5 cohort (11 days vs. 8 days, p = 0.04). There was no significant difference in survival at 30 days between groups (Figure). PVR and PCWP significantly decreased in both cohorts, while CI significantly increased (Table). The percent increase in CI was significantly greater in Impella 5.5 patients than in IABP patients (67.8% vs 33.6%, p=0.01). However, only the IABP cohort demonstrated significantly decreased mean pulmonary artery pressure (PAP) (-7.0 mmHg, p<0.01) and central venous pressure (CVP) (-3.5 mmHg, p=0.03). Exchanging IABP to Impella 5.5 significantly improved PVR (-50.92 dynes sec cm-5, p=0.03), but not other hemodynamic parameters. Conclusion: Both IABP and Impella 5.5 improve hemodynamics by decreasing pulmonary congestion and increasing cardiac output. While only the IABP significantly decreased mean PAP and CVP, the Impella 5.5 provided greater improvements in CI, and exchanging IABP for Impella 5.5 provided further reductions in PVR.Figure 1. 30-day survival after Impella 5.5 or IABP. - IABP (n=68) Impella 5.5 (n=25) P-value Age 59.10 (47.12-64.97) 44.58 (40.3-63.2) 0.1824 Female 19.1% (13/68) 12.0% (3/25) 0.5442 ICM 30.9% (21/68) 40.3% (10/25) 0.4585 Pre-op PVR 240.0 (176.0-344.0) 231.0 (191.8-344.0) 0.4294 Pre-op PCWP 30.0 (26.0-34.0) 27.0 (20.5-34.0) 0.1186 Pre-op mean PAP 41.5 (37.8-48.0) 40.0 (32.5-49.3) 0.1964 Pre-op CVP 14.0 (10.0-12.5) 14.0 (10.0-22.0) 0.3746 Pre-op CO 3.6 (3.0-4.4) 3.6 (3.0-4.6) 0.3184 Pre-op CI 1.7 (1.5-2.1) 1.9 (1.5-2.2) 0.3184 IABP => Impella 5.5 Pre-exchange Pre-explant P-value PVR 184.4 (111.9-253.1) 148.2 (94.45-214.2) 0.0290 PCWP 23.0 (18.8-27.8) 22.0 (16.0-31.0) 0.3398 Mean PAP 34.5 (29.0-38.3) 35.0 (32.0-38.0) 0.2142 CVP 12.0 (7.50-20.5) 13.0 (9.8-18.8) 0.4431 CO 4.3 (3.3-5.4) 4.9 (4.0-6.1) 0.1832 CI 2.1 (1.6-2.8) 2.3 (2.1-2.6) 0.1526

Randomized controlled trial assessing intubation time with and without an aerosol biocontainment device

Introduction: The emergence of the coronavirus disease 2019 (COVID-19) pandemic renewed interest in infectious aerosols and methods to reduce risk of airborne respiratory pathogen transmission. This has led to the development of novel aerosol protective devices for which clinical and aerosol protective features have not been fully characterized. The relative efficacy of these devices for use during airway procedures has not been assessed in randomized controlled trials. Materials and Methods: We recruited anesthesiology attendings, residents, and certified registered nurse anesthetists to perform intubations with an aerosol biocontainment device (ABCD). Thirty-seven patients undergoing procedures requiring intubation in the operating room were recruited and randomized (2:1) to intubation with (25) or without (12) the ABCD. Primary endpoints were time to secure the airway and adverse events. Secondary endpoints were a number of intubation attempts, access to the patient and airway equipment through the device ports, user assessment of ABCD function and technical burden, and patient experience in the ABCD. Results: Intubation time with the ABCD (46 s) was not significantly different compared to intubation without the ABCD (37 s; P=0.06). There were 3 adverse events with the ABCD (1 claustrophobia, 2 unanticipated difficult airways) that required device removal for intubation. In general, patients tolerated the device well and ABCD users felt the device functioned as intended but increased the technical burden associated with intubation. Discussion: It is feasible to use an aerosol protective device for intubation. The introduction of novel devices into high acuity airway procedures should be approached with caution and should account for the risk mitigation gained from the device balanced against the increased procedural complexity and potential safety risks associated with restricted access to the airway.