Device Removal Research Articles

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.

Comparison of distal transradial approach versus conventional transradial approach for coronary angiography and percutaneous coronary intervention: A prospective observational study

BackgroundCompared with the conventional transradial approach (TRA), there are limited data on the efficacy and safety of the novel distal transradial approach (DTRA). This study aimed to verify the effectiveness and safety of the DTRA for percutaneous coronary angiography and intervention. Besides, we also try to highlight the potential of the DTRA in reducing radial artery occlusion (RAO), shorter time to hemostasis, and improved patient comfort. MethodsThis single-center prospective observational study enrolled patients treated with DTRA (n = 527) in the first 9 months and with TRA (n = 586) in the next 8 months from May 2020 to December 2021. The primary endpoint was the proximal RAO rate at 30 days. ResultsBaseline data were similar between the two groups. The proximal radial artery occlusion rate at 30 days [2.3% vs. 7.0%], the success rate of puncture [86.4% vs. 96.7%], the Numeric Rating Scale score [1.97 ± 1.89 vs. 4.61 ± 2.68], and the incidence of postoperative subcutaneous hematoma and finger numbness [3.4% vs. 8.2%, 2.7% vs. 4.4%] were lower. The puncture time [6.93 ± 7.25 min vs. 3.18 ± 3.52 min] was longer, and the time until radial compression device removal was shorter [CAG: 138.61 ± 38.73 min vs. 191.6 ± 61.22 min, PCI:221.46 ± 62.45 min vs. 276.28 ± 76.39 min] in the DTRA group than TRA group (all P < 0.05). Multivariate logistic regression analysis revealed that the DTRA (OR 0.231, 95% confidence interval [CI] 0.088–0.769, P = 0.001),BMI<18.5 kg/m2 (OR 2.627, 95% CI 1.142–4.216, P = 0.004), Diabetes mellitus (OR 2.15, 95%CI1.212–3.475, P = 0.014), RCD removal time (CAG,min) (OR 1.091, 95% CI 1.013–1.441, P = 0.035) and RCD removal time (PCI,min) (OR 1.067, 95% CI 1.024–1.675, P = 0.022) were the independent risk factors of RAO 1 month after intervention procedure. ConclusionDTRA was found to a lower incidence of postoperative RAO and bleeding-related complications, shorter time to achieve hemostasis, and greater patient comfort.

ID: 217339 Minimally Invasive Finding and Removal of an Injectrode in Hydrogel and Chronic Preclinical Models

In developing a neuromodulation device that is intuitive for clinicians and safe for patients, one main challenge is to provide a simple and reliable procedure for device removal. Neurostimulators are always removed at the conclusion of their trial periods and are commonly removed for lead placement revisions or due to complications such as infection or migration resulting in loss of function. Current neurostimulators have limiting design features that complicate the removal procedure.1,2 Here, we demonstrate that an Injectrode, a helical wire rope structure electrode, exhibits properties that allow for removal from the body easily, quickly, and completely.

Systematic Review on S-ICD Lead Extraction.

Subcutaneous implantable cardioverter defibrillators (S-ICDs) have emerged in recent years as a valid alternative to traditional transvenous ICDs (TV-ICDs). Therefore, the number of S-ICD implantations is rising, leading to a consequent increase in S-ICD-related complications sometimes requiring complete device removal. Thus, the aim of this systematic review is to gather all the available literature on S-ICD lead extraction (SLE), with particular reference to the type of indication, techniques, complications and success rate. Studies were identified by searching electronic databases (Medline via PubMed, Scopus and Web of Science) from inception to 21 November 2022. The search strategy adopted was developed using the following key words: subcutaneous, S-ICD, defibrillator, ICD, extraction, explantation. Studies were included if they met both of the following criteria: (1) inclusion of patients with S-ICD; (2) inclusion of patients who underwent SLE. Our literature search identified 238 references. Based on the abstract evaluation, 38 of these citations were considered potentially eligible for inclusion, and their full texts were analyzed. We excluded 8 of these studies because no SLE was performed. Eventually, 30 studies were included, with 207 patients who underwent SLE. Overall, the majority of SLEs were performed for non-infective causes (59.90%). Infection of the device (affecting either the lead or the pocket) was the cause of SLE in 38.65% of cases. Indication data were not available in 3/207 cases. The mean dwelling time was 14 months. SLEs were performed using manual traction or with the aid of a tool designed for transvenous lead extraction (TLE), including either a rotational or non-powered mechanical dilator sheath. SLE is performed mainly for non-infective causes. Techniques vary greatly across different studies. Dedicated tools for SLE might be developed in the future and standard approaches should be defined. In the meantime, authors are encouraged to share their experience and data to further refine the existing variegated approaches.

Subcutaneous implantable cardioverter-defibrillator generator removal: a multicenter analysis

Abstract Funding Acknowledgements Type of funding sources: Public hospital(s). Main funding source(s): University Hospital Cologne Introduction The subcutaneous implantable cardioverter-defibrillator (S-ICD) was a significant recent advance in sudden cardiac death prevention. Device-related complications, including infection or lead fracture, or changes in the medical status, such as necessity for cardiac pacing, may necessitate device removal. (1) Real-world multicenter data on S-ICD removal are sparse. Purpose This multicenter analysis sought to assess the incidence and indications for S-ICD generator removal. Methods Retrospective data and the most recent follow-up data on S-ICD devices implanted at 14 participating centers in Europe, the US and Canada, and information on subsequent device removal was submitted to an online database (2). Limited baseline patient information and the incidence of and reasons for S-ICD generator removal or failure were reported. Premature device removal was defined as device removal for any reason other than regular battery depletion (&amp;gt;5 years of longevity). Results Data from 1106 devices was analyzed. Devices were implanted between 15.10.2009 and 16.04.2021 at the participating centers. The first-generation model 1010 generator was implanted in 55 (5%), the newer models A209 or A219 were implanted in 457 (41.3%) and 594 (53.7%) respectively. Patients were aged 46.7±16.1 years and the indication for ICD therapy was primary prevention in 616 (55.7%) and secondary prevention in 484 (43.8%). During the follow-up period, 37 (3%) patients deceased, and 96 patients were excluded from the analysis due to lack of follow-up (&amp;lt;4 weeks). Premature device removal was performed in 103 (9.3%) during the follow-up period of 31.3±19.5 months. The most common reasons for removal were battery depletion (52%), of which premature, defined as &amp;lt;5 years longevity, depletion accounted for 57%, upgrade to transvenous ICD or CRT (17%) and infection (11%). Other indications for removal included heart transplantation (4%) or ventricular assist device implantation (1.5%), noise detection or inappropriate shocks (6.5%), and patient discomfort (0.7%). (see figure 1) Regular battery depletion occurred in 34 devices after 69.2±5.3 months. There was no difference in device longevity between the different generator models (1010, A209, and A219). There were no significant differences between the different generator models with respect to indications for explanation. Conclusions In this real-world retrospective multicenter analysis, premature S-ICD generator removal was necessary in 9.3% of patients. Premature battery depletion, infections, and the need for pacing were the most common indications for unplanned generator removal.

A Novel Antibiotic Delivery Approach for Salvage of Cardiovascular-Implantable Electronic Devices with Localized Infection

Abstract Funding Acknowledgements Type of funding sources: None. Background Present guidelines endorse complete removal of cardiovascular-implantable electronic devices (pacemakers/defibrillators), including extraction of intracardiac electrodes, not only for systemic infections but also for localized "pocket infections." Objectives We evaluated the efficacy of delivering "Continuous, In-situ-Targeted, ultra-high concentration of Antibiotics" (CITA) into the infected subcutaneous the device-pocket, obviating the need for device/lead-extraction. Methods The CITA-Group consisted of 80 patients with pocket infection who were treated with CITA during 2007-2021. Of them, nine patients declined lead-extraction because of prohibitive operative risk, and six patients had questionable indications for extraction. The remaining 65 patients with pocket infection, who were eligible for extraction but opted for CITA treatment, were compared to 81 patients with pocket infection and similar characteristics who underwent device/lead-extraction as primary therapy. Results Eighty patients with pocket infection were treated with CITA during 2007-2021. CITA was curative in 85% (68/80) patients, who remained free of infection (median follow-up: 3 years, interquartile range 1 – 6.8 years). In the case-control study of CITA vs. device/lead extraction, cure rates were higher after device/lead-extraction than after CITA [96.2%; (78/81) vs. 84.6%; (55/65), p=0.027]. However, rates of serious complications were also higher after extraction [12 (14.8%) vs. 1 (1.5%), p=0.005]. All-cause 1-month and 1-year mortality were similar for CITA and device/lead-extraction (0% vs. 3·7%, p=0·25 and 12·3% vs. 13·6%, p=1·00, respectively). Extraction was avoided in 90·8% (59/65) extraction-eligible patients treated with CITA. Conclusions CITA is a safe and effective alternative for patients with pocket infection who are unsuitable or unwilling to undergo extraction.

Complicated pocket infection in patients undergoing lead extraction - a new entity?

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Cardiac implantable electronic device (CIED) infection can present with either pocket or systemic manifestations, both necessitating complete device removal and pathogen-directed antimicrobial therapy. However, some may present with both pocket and systemic infection. We aim to characterize those with complicated pocket infection. Methods A retrospective analysis of all CIED extraction procedures at our medical center from 07/2010 to 12/2018 was performed. Patients were divided to simple pocket infection, complicated pocket infection and systemic infection groups. Results A total of 300 patients were included; 104 (34.7%) had a simple pocket infection, 142 (47.3%) had a systemic infection alone and 54 (18%) presented with a complicated pocket infection. Most were males, with a similar mean age at time of extraction. No differences in comorbidities were observed, except for higher prevalence of diabetes (54.2%) in the systemic infection group (p=0.002). Patients with a systemic and complicated pocket infection presented more frequently with leukocytosis and fever &amp;gt; 37.8, as opposed to the simple pocket infection group. Staph Aureus was the most common pathogen in the systemic and complicated pocket infection groups (43.7% and 31.5% respectively) while CONS predominated (31.7%) for the simple pocket infection group (10.6%, p&amp;lt;0.001). No differences were observed in procedural success rates or complications of the extraction procedure. Kaplan Meier survival analysis showed that at 3 years of follow-up the rate of all-cause mortality was significantly higher among patients with systemic infection compared to both pocket infection groups which were similar (p&amp;lt;0.001), with the curves diverging at 30 days. Multivariate analysis demonstrated high creatinine and lower albumin were predictors of 30 days and 1 year mortality while age and the presence of atrial fibrillation were predictors of 1 year mortality only. Conclusions We characterize a new entity of a complicated pocket infection. Albeit the similarity to the systemic infection group regarding clinical manifestation, those with complicated pocket infection carry a better prognosis than those with systemic infection alone.

(443) A Randomized Prospective Evaluation of Next-generation Sequencing Versus Traditional Cultures for Clinically Infected Penile Prostheses: Impact of Microbial Identification on Outcomes

Abstract Introduction Traditional culture is the current standard-of-care to determine therapeutic antibiotics for patients suffering from penile prostheses (PP) infections. However, approximately 50% of PPs removed for infection are culture negative. Next-generation sequencing (NGS) of DNA has proven to be beneficial in its thorough analysis of biofilm composition and determination of the relative abundance of specific microbes. In this prospective, multicenter, single-blinded, randomized controlled trial, we hypothesize that the use of NGS will lead to better therapeutic strategies that will result in improved patient outcomes by determining the microbial composition of infected PP. Objective We present our early results from our prospective study that compares outcomes of microbial identification between NGS versus culture for clinically infected PP. Methods Upon institutional review board approval, adult men undergoing treatment for mild to moderate PP infection are enrolled after providing informed consent. Enrollees are randomized to one of two analytic arms – traditional culture or NGS, using Captivate by ClinCapture. Patients with severe infection requiring urgent explantation are excluded. Traditional culture and NGS samples are collected upon clinical presentation prior to initiation of antibiotics. Specimens of infected fluid were collected, stored in sterile packaging, and transported for both traditional culture at the institutional laboratory and NGS testing (MicroGenDX, Lubbock, TX). Patients are started on set empiric antibiotics and randomized to traditional culture or NGS. Patients with a positive culture or NGS result will receive treatment-specific antibiotics, while patients with negative results continue empiric antibiotics for two weeks. For patients randomized to the NGS arm, positive results will undergo central infectious disease (ID) review, and antibiotics initiated based on their recommendations. Patients will follow up within ten days of antibiotic initiation and at six months to complete a safety and compliance questionnaire which assesses symptoms, device function, and patient satisfaction. Results To date, two patients have been enrolled. The first patient was randomized to the culture arm and presented with mild tenderness and drainage around the scrotal pump area for five days but remained afebrile. His culture resulted as Citrobacter koseri. He started empiric treatment with amoxicillin-clavulanate which was changed to ciprofloxacin based on culture results. The second patient was randomized to the NGS arm and presented with four days of bloody and purulent drainage from the scrotal pump area. Although he was afebrile, he had moderate tenderness, swelling, and erythema in his scrotum. NGS identified multiple organisms (data remains blinded). He was started on empiric trimethoprim-sulfamethoxazole but was treated successfully with a course of cefdinir and doxycycline per ID. Both patients had primary implants and did not require device removal. On the post-treatment questionnaire, both patients reported that their devices were working and endorsed high satisfaction rates. Conclusions This is the first prospective, randomized controlled trial comparing the utility and outcomes of NGS and culture for the identification of microbes in clinically infected PP. Currently, recruitment is ongoing. We hope that this trial will demonstrate a clinical benefit of NGS in characterizing distinct microbiomes of infected PP to tailor antimicrobial therapy. Disclosure Yes, this is sponsored by industry/sponsor: MicroGenDX Clarification Industry funding only - investigator initiated and executed study Any of the authors act as a consultant, employee or shareholder of an industry for: MicroGenDX

(114) Initial Safety Outcomes for Rigicon Infla 10® Inflatable Penile Prosthesis

Abstract Introduction A new three-piece inflatable penile prosthesis was introduced in 2019. The Rigicon Infla10® has been implanted in 26 centers by 103 physicians. Clinical investigation for FDA approval in United States will begin in late 2022. Objective We report initial survival from explantation and revision rates for infection, mechanical failure and medical problems. Data was obtained from analysis of Patient Information Forms (PIFs) submitted to the manufacturer. Patient information data was omitted prior to analysis. Methods 319 patients implanted from 1/06/2019 to 12/31/2021 were followed to analyze device durability from revision/removal and rates of reoperation for infection, mechanical failure or medical reason. Results Mean follow-up was 21.2 months with a range of 5-36 months. Mean age was 58.5. 4.38% required removal/revision. Mechanical failure was 2.5%. There were no infections reported and only two (0.6%) medical problems (component out of place). One Peyronie's patient required revision for inadequate straightening (0.03% Three patients (0.9%) requested device removal for dissatisfaction. A total of 95.6% of Rigicon Infla10® was free from explant or revision 13 months from the original implant date. Kaplan Meier analysis revealed cumulative survival of the device at 12, 24 and 36 months was 95.6%, 94.7% and 95.7% until surgical invention. Conclusions While this is a retrospective study derived from volunteered Patient Information Forms, we believe the vast majority of the early Rigicon Infla10® performed prior to 1/2022 were included in the analysis. Early results show initial durability from re-operation equivalent to contemporary, devices. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Rigicon, Boston Scientific, Coloplast.

36. Cephalometric Imaging Sheds Light on the Effects of Mandibular Distraction on Infants with Robin Sequence

PURPOSE: Upper airway obstruction (UAO) in infants with Robin Sequence (RS) is secondary to micrognathia and resultant posterior displacement of the tongue. Mandibular distraction osteogenesis (MDO) is a safe and effective treatment for significant UAO, but there is a paucity of data examining associated cephalometric changes. This study carefully examines mandibular cephalometric changes of infants with RS who underwent MDO using internal devices to more deeply understand both immediate and longer-term effects of distraction on mandibular shape. METHODS: Consecutive infant MDO cases (n=53) performed by the same surgeon were analyzed using preoperative and postoperative lateral cephalograms and CT scans of the mandible. Population averages for preoperative and postoperative time points were assessed using a two-sample t-test with equal variance. RESULTS: Significant post-operative morphologic changes were seen in 19 of 21 cephalometric parameters. Length, height, width, and airway parameters improved on average by 20.3 mm (60.7%), 9.8 mm (49.7%), 12.6 mm (36.1%), and 211%, respectively. The majority of cephalometric measurements displayed substantial percent change from the preoperative timepoint to device removal and a much less dramatic percent change from device removal to 6-12 months postoperatively. In fact, none of the parameters measuring mandibular length and angular cephalometrics were significant from device removal to 6-12 months after MDO. CONCLUSION: Cephalometric measurement is a powerful tool that provides a concrete metric to understand how MDO affects not just the immediate but also long-term growth of the mandible. Understanding the more quantifiable effects of mandibular distraction will allow for fine-tuning of surgical practice and optimization of outcomes.

Detachable Microneedles via Host–Guest Supramolecular Polymer Networks

Point-of-use devices to conveniently deliver protein therapeutics are of growing need. Microneedles offer an approach to deliver biopharmaceuticals across the skin and circumvent syringe-based injection or harsh oral environments. Certain microneedles rapidly dissolve to deliver their payload, while others affix to the skin for sustained release. Here, a microneedle platform combining a PEG-based supramolecular polymer network with a mechanical biopolymer network is able to penetrate the skin, where the microneedles subsequently swell; those composed of supramolecular cross-links detach upon device removal. The embedded supramolecular microneedles afford sustained delivery of insulin for >12 h of blood glucose correction following only 5 min of skin application. Conversion of the supramolecular cross-links to a covalent form prevents microneedle detachment, with brief application failing to correct blood glucose. This approach offers a simple route of fabricating detachable microneedles using polymer formulations with supramolecular bonding, improving on the complex fabrication of previous detachable microneedle designs.

Duodenal-jejunal bypass liners are superior to optimal medical management in ameliorating metabolic dysfunction: A systematic review and meta-analysis.

This systematic review and meta-analysis evaluates metabolic and anthropometric outcomes of duodenal-jejunal bypass liners (DJBLs) compared to optimal medical management for the treatment of obesity and its associated metabolic complications. A systematic search of MEDLINE, Embase, Scopus, and Web of Science databases was conducted. Studies were reviewed and data were extracted following the PRISMA guidelines. The primary outcome was glycated hemoglobin (HbA1c) change at device explant with secondary outcomes including body mass index (BMI), weight, fasting plasma glucose (FPG), and adverse events. Twenty-eight studies met inclusion criteria evaluating a total of 1229 patients undergoing DJBL treatment. When compared to medical management, DJBLs provided superior reductions in HbA1c (mean difference, MD -0.96%; 95% CI -1.43, -0.49; p < 0.0001), FPG (MD -1.76 mmol/L; 95% CI -2.80, -0.72; p = 0.0009), BMI (MD -2.80 kg/m2 ; 95% CI -4.18, -1.41; p < 0.0001), and weight (MD -5.45 kg; 95% CI -9.80, -1.09, p = 0.01). Post-explant data reveals a gradual return to baseline status. Incidence of early device explant was 20.2%. Complications were resolved conservatively or with device explant without long-term morbidity or mortality. We conclude that DJBLs provide significant metabolic and anthropometric improvements for patients with obesity. Uncertainty about the extent to which improvements are maintained after device removal may limit the use of DJBLs as a standalone treatment for obesity and associated metabolic complications.

Predictors of successful weaning from VA-ECMO: the role of CS etiology and related treatment

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is a short-term mechanical circulatory support for refractory cardiogenic shock (CS). Successful weaning from VA ECMO is defined as device removal without further requirement for re-cannulation over the following 30 days. Few data exist regarding timing and reliable parameters for weaning from VA-ECMO: most study focused on echocardiographic and invasively monitored parameters during weaning trial(1,2). No data exist concerning pharmacological support and standard haemodynamic parameters in the first 24 hours since VA-ECMO implantation. Purpose We sought to evaluate hemodynamic predictors of VA-ECMO weaning. Methods Single-center retrospective observational study of patients with refractory CS who underwent VA-ECMO insertion from 2013 to 2020 in Intensive Care Unit (ICU). Primary endpoint was successful weaning from VA ECMO. Demographic, clinical, hemodynamic data within the first 24 hours and outcome were collected. We also recorded maximum dose of each vasoactive medication, Vasoactive Inotropic Score (VIS)(3) after VA-ECMO implantation and the total amount of time exposition to vasoactive drugs. Results 100 patients (26% female; 52,6±12,6 y.o.) who underwent VA-ECMO cannulation were enrolled (Table 1). 31 were successfully weaned (31%) at a median time of 140,0 [74,3-229,0] hours; 30-days mortality was 47%. 79 (79%) patients were admitted for cardiac arrest (CA); 48 (48%) had acute myocardial infarction (AMI)-CS. CA patients were less likely to be weaned: 20,3% of CA patients had successful VA-ECMO removal while 79,4% was not weaned (p &amp;lt;0,001). In the weaned group, mean blood pressure was significantly higher (75,3±18,2 vs 61,4±18,3 mmHg; p &amp;lt;0,01).Patients who successfully removed VA-ECMO had lower serum lactate (8,8±5,2 vs 11,3±5,0 mmol/L; p &amp;lt;0,05), lower fluid balance (+2,3 [0,5-5,5] vs +4,1 [1,7-8,3] L/die; p &amp;lt;0,05) and lower Sequential Organ Failure Assessment (SOFA) score (11,2±2,6 vs 13,2±3,4; p &amp;lt;0,01). Lower doses of norepinephrine was administered in patient successfully weaned (0,27±0,17 vs 0,44±0,25 mcg/kg/min; p &amp;lt;0,01). Despite not significant, lower VIS and time to exposition to vasoactive drugs amongst weaned patients were observed (p=0,08 and p=0,09, respectively). Stepwise logistic regression confirmed the worst outcome of CA patients (OR 0,64; p &amp;lt;0,001), SOFA score (OR 0,81; p &amp;lt;0,05) and time to exposition to vasoactive drugs (OR 0,81; p &amp;lt;0,05) on successful weaning from VA-ECMO. Conclusions Mortality of patients undertaking VA-ECMO still remains high. Amongst the data in the model, the strongest negative association with successful weaning from VA-ECMO was found for CA, according to the latest classification entailing CA as CS severity modifier(4). Other results show higher requirement of norepinephrine and fluid administration for vasoplegia mostly related to hypoxic organ injury and related infection (i.e. bowel translocation).

E-46 | Bedside Removal of Impella Devices in Cardiogenic Shock Patients Is Feasible and Safe

Patients with cardiogenic shock (CS) requiring mechanical circulatory support (MCS) are complex. The Impella CP (Abiomed, Danvers, MA) is a percutaneously placed left ventricular assist device and there is no established best-practice for device removal. Vascular complications from MCS devices are common and many patients undergo operative removal of these devices. To our knowledge there is no published data concerning the safety of bedside removal of femorally-placed Impella devices in the cardiovascular intensive care unit (CICU) for patients with CS. We conducted a retrospective chart review of all CS patients requiring MCS at our institution in 2020, approved by our institutional review board. In 2020 we cared for 84 patients requiring MCS in our CICU, excluding patients with intra-aortic balloon pumps. Of these, 55 patients had a femorally-placed Impella CP, either alone or with veno-arterial extracorporeal membrane oxygenation. 18 patients died with devices in place and three were transferred to another facility on MCS. 14 patients had their Impella removed in the operating room and five in the cardiac catheterization lab. 15 total patients (27%) underwent Impella removal at bedside in the CICU. Of the patients with bedside removal, a vascular closure device was used in the vast majority (87%). Only one patient had post-removal leg ischemia requiring surgical or endovascular intervention; this patient had preexisting peripheral vascular disease and the Impella was removed via manual pressure for clinical ischemia. Bedside removal of femorally-placed Impella CP devices is feasible and safe in select CS patients. More research is needed to establish best-practices for MCS device removal.

PO-04-075 TRANSVENOUS CARDIAC DEFIBRILLATOR WITHOUT INTERACTION WITH THE MAGNETIC TITANIUM BEADS SYSTEM FOR GASTROESOPHAGEAL REFLUX DISEASE

Gastroesophageal reflux is increasingly treated with LINX®, a flexible bracelet of magnetic titanium beads (not MRI compatible) that is laparoscopically implanted to wrap around the gastroesophageal junction for providing tone/support aiding passive relaxation of a weak lower esophageal sphincter with peristalsis. The FDA currently cautions against concurrent use of the LINX® system with cardiac implantable electronic devices (CIEDs) given that the risk of electromagnetic interference (EMI) is unknown, and safety has not been established. We assessed the safety of a transvenous ICD in a patient with the LINX® system. Case Report 59 year old male who previously had the LINX® system implanted after hiatal hernia repair for refractory reflux. Shortly after, he was then diagnosed with apical hypertrophic cardiomyopathy with obstruction (NYHA Class I, genetic testing revealed VUS in CSRP3). Given non-sustained VT on cardiac event monitoring, family history of sudden cardiac death (SCD) and late gadolinium enhancement on cardiac magnetic resonance imaging with a calculated 5-year SCD risk 4.1%, he was recommended ICD implantation for primary prevention. Patient underwent an uneventful transvenous dual chamber defibrillator implantation. Although we do not routinely perform (DFT) testing at our institution, given the coexisting LINX® system in close proximity to the RV lead, we elected to proceed with DFT Testing, which was successful (1 induction: T-wave shock from sinus to VF, 30J delivered successfully to sinus with 7s charge time, no ATP, 70 ohms impedance). Patient underwent routine remote device interrogations and at 1-year follow up (which included an in-person device interrogation), continues to have normal lead parameters (sensing, impedance, threshold), minimal atrial or ventricular pacing, and no recurrent arrhythmias including NSVT (was started on verapamil). Specifically, patient received no inappropriate shocks, and no high frequency noise episodes were detected. We present the first case report of a patient who had a concomitant dual chamber ICD that was implanted shortly after a LINX device placement. We demonstrate normal DFTs at implant and no device interaction at 1 year follow-up, suggesting that ICD implantation without removal of the LINX device might be reasonable. Decision-making for cardiac device implantation decisions in such patients should consider additional theoretical risks until additional data with more patients is available.

PO-02-086 A NOVEL ANTIBIOTIC DELIVERY APPROACH FOR SALVAGE OF CARDIOVASCULAR-IMPLANTABLE ELECTRONIC DEVICES WITH LOCALIZED INFECTION

Present guidelines endorse complete removal of cardiovascular-implantable electronic devices (pacemakers/defibrillators), including extraction of intracardiac electrodes, not only for systemic infections but also for localized “pocket infections.” We evaluated the efficacy of delivering “Continuous, In-situ-Targeted, ultra-high concentration of Antibiotics” (CITA) into the infected subcutaneous the device-pocket, obviating the need for device/lead-extraction. The CITA-Group consisted of 80 patients with pocket infection who were treated with CITA during 2007-2021. Of them, nine patients declined lead-extraction because of prohibitive operative risk, and six patients had questionable indications for extraction. The remaining 65 patients with pocket infection, who were eligible for extraction but opted for CITA treatment, were compared to 81 patients with pocket infection and similar characteristics who underwent device/lead-extraction as primary therapy. Eighty patients with pocket infection were treated with CITA during 2007-2021. CITA was curative in 85% (68/80) patients, who remained free of infection (median follow-up: 3 years, interquartile range 1 – 6.8 years). In the case-control study of CITA vs. device/lead extraction, cure rates were higher after device/lead-extraction than after CITA [96.2%; (78/81) vs. 84.6%; (55/65), p=0.027]. However, rates of serious complications were also higher after extraction [12 (14.8%) vs. 1 (1.5%), p=0.005]. All-cause 1-month and 1-year mortality were similar for CITA and device/lead-extraction (0% vs. 3.7%, p=0.25 and 12.3% vs. 13.6%, p=1.00, respectively). Extraction was avoided in 90.8% (59/65) extraction-eligible patients treated with CITA. CITA is a safe and effective alternative for patients with pocket infection who are unsuitable or unwilling to undergo extraction.

Acceptability and validity of using the BACtrack skyn wrist-worn transdermal alcohol concentration sensor to capture alcohol use across 28 days under naturalistic conditions - A pilot study.

Wrist-worn transdermal alcohol concentration (TAC) sensors have the potential to provide detailed information about day-level features of alcohol use but have rarely been used in field-based research or in early adulthood (i.e., 26-40 years) alcohol users. This pilot study assessed the acceptability, user burden, and validity of using the BACtrack Skyn across 28 days in individuals' natural settings. Adults aged 26-37 (N=11, Mage=31.2, 55% female, 73% non-Hispanic white) participated in a study including retrospective surveys, a 28-day field protocol wearing Skyn and SCRAM sensors and completing ecological momentary assessments (EMA) of alcohol use and duration (daily morning reports and participant-initiated start/stop drinking EMAs), and follow-up interviews. Day-level features of alcohol use extracted from self-reports and/or sensors included drinks consumed, estimated Blood Alcohol Concentration (eBAC), drinking duration, peak TAC, area under the curve (AUC), rise rate, and fall rate. Repeated-measures correlations (rrm) tested within-person associations between day-level features of alcohol use from the Skyn versus self-report or the SCRAM. Participants preferred wearing the Skyn over the SCRAM [t (10)=-6.79, p<.001, d=2.74]. Skyn data were available for 5614 (74.2%) out of 7566h, with 20.7% of data lost due to syncing/charging issues and 5.1% lost due to device removal. Skyn agreement for detecting drinking days was 55.5% and 70.3% when compared to self-report and the SCRAM, respectively. Correlations for drinking intensity between self-report and the Skyn were 0.35 for peak TAC, 0.52 for AUC, and 0.30 for eBAC, which were smaller than correlations between self-report and SCRAM, at 0.78 for peak TAC, 0.79 for AUC, and 0.61 for eBAC. Correlations for drinking duration were larger when comparing self-report to the Skyn (rrm=0.36) versus comparing self-report to the SCRAM (rrm=0.31). The Skyn showed moderate-to-large, significant correlations with the SCRAM for peak TAC (rrm=0.54), AUC (rrm=0.80), and drinking duration (rrm=0.63). Our findings support the acceptability and validity of using the Skyn for assessing alcohol use across an extended time frame (i.e., 28 days) in individuals' natural settings, and for providing useful information about day-level features of alcohol use.

Early Infective Endocarditis Associated with an Amplatzer Atrial Septal Occluder Device in a 14-Year-Old Male.

Infective endocarditis (IE) associated with an ASD device, particularly in the early post-procedure period, is extremely rare. We report a case of infective endocarditis presenting with embolic complications and vegetations on the device that were only seen on transesophageal echocardiography, necessitating device removal.