Device Replacement Research Articles

(114) A Comparative Meta-Analysis of Revision Strategies for Malfunctioning Inflatable Penile Prosthesis: Partial vs Complete Component Replacement With or Without Retained Reservoir

Abstract Introduction In cases of non-infected malfunctioning Inflatable penile prosthesis (IPP) device, surgeon often opt to exchange all the device rather than the defective component for fear of increased infection rate and future mechanical dysfunction. Objective To assess whether partial component exchange of IPP device has comparable outcomes to complete explant and replacement of IPP device with or without retained reservoir. Methods A meta-analysis was completed in line with PRISMA 2020 and AMSTAR guidelines. A comprehensive search was done on MEDLINE (OVID), PubMed, and Cochrane Library electronic databases from their inceptions until May 2023, identifying studies that reported on outcomes and complications of revision surgery for non-infected malfunctioning IPP device. Three groups were compared: the first group underwent a single or two-component exchange, the second group had a complete explant replacement of the entire device, and the third group had replacement of all components with a drained and retained primary reservoir. Results A total of 9 articles were included in the analysis. 12,152 patients had complete replacement of their device, 128 had partial exchange of their device and 151 patients had “drained and retained” reservoir following revision. The mean age was similar among the 3 groups between 62–68 years. The median follows up time ranged between 12 and 79 months. Partial component ex change had a higher rate of mechanical failure 10.3% versus 1.3% and 2.3 % (p=0.03) for complete and “drain and retain” groups respectively. (Figure 1) Similarly, partial component exchange had higher peri-operative complications at 21.2% compared to complete replacement group 9.5% and “drain and retain” group 14.5% (p=0.022). However, the infection rate was similar among the three groups, 7.7%, 2.7% and 3.3% respectively (p= 0.301). (Figure 2) Conclusions Partial component exchange during IPP revision has higher rates of perioperative complication and future mechanical failure but has similar rate of infection compared to complete component replacement with or without “drain and retain” of original reservoir. Disclosure No.

(161) Is there a Difference in Inflatable Penile Prosthesis Mechanical Failure and Infections Rates in Relation to Prostate Cancer Treatment Modality (Radiation Therapy vs Radical Prostatectomy)

Abstract Introduction Inflatable Penile Prosthesis (IPP) implantation as a treatment for ED has high satisfaction rates in the general population; however, there is limited literature on quantification of complication rates as stratified by ED etiology. Objective Our aim was to compare mechanical failure and infection rates in patients undergoing IPP implantation for ED following Radical Prostatectomy (RP) versus radiation therapy (RT) for prostate cancer. Methods A retrospective chart review from our institutional database was conducted to identify 405 patients who underwent IPP placement at our institution from 2015–2019, then selecting for those whose etiology of ED was following RP or RT. To prevent crossover confounding; patients with history of pelvic radiation or salvage radiotherapy were excluded from the RP group and patients with history of RP were excluded from the RT group. Data was obtained from 75 patients who met criteria for inclusion: 44 patients in the RP group and 31 patients in the RT group. Mechanical failure, infection rates, mean EDITS scores and additional survey questions were compared between the radiation and RP groups. Results Patient demographic information and IPP complication and satisfaction rates are listed below in Table 1 and Figure 1. There was a statistically significant difference in number of patients experiencing IPP complications, 19.4% (n=6) of patients in the RT cohort and 4.5% (n=2) in the RP cohort, respectively. There was no statistically significant difference found in stratified complications- infection rates, device erosion rates, mechanical failure rates, or device removal and/or replacement rates between the two groups. The RP cohort had a significantly higher mean Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire score versus the RT cohort, 91.58 to 76.02, respectively. Conclusions These preliminary findings, while requiring large-scale follow up, suggest that there is a higher rate of IPP related complications in patients with device placement following RT for prostate cancer versus RP. Disclosure No.

Effectiveness and safety of XEN 63 in patients with primary-open-angle glaucoma

This paper evaluates the effectiveness and safety of XEN63 stent, either standalone or in combination with phacoemulsification, in patients with primary open-angle glaucoma (POAG). Eighty eyes from 80 patients with medically uncontrolled POAG were assigned to undergo XEN63 implant. The primary outcome was the surgical success, defined as an intraocular pressure (IOP) lowering from preoperative values ≥ 20% and an IOP absolute value between 6 and 18 mmHg, with or without antiglaucoma medications. Forty-three (53.7%) eyes underwent XEN63-standalone and 37(46.2%) eyes a XEN63 + Phacoemulsification procedure. Success rate was 68.8% (55/80) eyes in the overall study sample, 69.8% (30/43) eyes in the XEN63-standalone group; and 67.6% (25/37) eyes in the XEN63 + Phaco group (p = 0.6133). Preoperative IOP was significantly lowered from 22.1 ± 4.9 mmHg and 19.8 ± 3.7 mmHg to 14.7 ± 5.3 mmHg and 13.8 ± 3.4 mmHg in the XEN63-standalone and XEN63 + Phaco groups, respectively (p < 0.0001 each, respectively); without significant differences between them at any of the time-points measured. Preoperative number of ocular-hypotensive drugs was significantly reduced from 2.3 ± 0.8 to 0.3 ± 0.7 drugs, from 2.5 ± 0.7 to 0.3 ± 0.7 drugs; and from 2.0 ± 0.8 to 0.3 ± 0.7 drugs, in the overall, XEN63-standalone, and XEN63 + Phaco groups, respectively. Regarding safety, 3(42.5%) eyes had transient hypotony at some point during the study, although only in one (1.2%) eye was clinically significant. Four (5.0%) eyes underwent a needling, 4 (5.0%) eyes underwent surgical-bleb-revision, 1 (1.2%) eye required a device replacement and 1 (1.2%) eye a device removal due to maculopathy. XEN63, either alone or in combination with phacoemulsification, significantly lowered IOP and reduced the number of ocular hypotensive medications. The rate of ocular hypotony was relatively high, although it was clinically relevant only in one eye.

(391) A Comparative Meta-analysis of Revision Strategies for Malfunctioning Inflatable Penile Prosthesis: Partial Vs Complete Component Replacement With or Without Retained Reservoir

Abstract Introduction In cases of non-infected malfunctioning Inflatable penile prosthesis (IPP) device, surgeon often opt to exchange all the device rather than the defective component for fear of increased infection rate and future mechanical dysfunction. Objective To assess whether partial component exchange of IPP device has comparable outcomes to complete explant and replacement of IPP device with or without retained reservoir. Methods A meta-analysis was completed in line with PRISMA 2020 and AMSTAR guidelines. A comprehensive search was done on MEDLINE (OVID), PubMed, and Cochrane Library electronic databases from their inceptions until May 2023, identifying studies that reported on outcomes and complications of revision surgery for non-infected malfunctioning IPP device. Three groups were compared: the first group underwent a single or two-component exchange, the second group had a complete explant replacement of the entire device, and the third group had replacement of all components with a 'drained and retained' primary reservoir. Results A total of 9 articles were included in the analysis. 12,152 patients had complete replacement of their device, 128 had partial exchange of their device and 151 patients had “drained and retained” reservoir following revision. The mean age was similar among the 3 groups between 62-68 years. The median follow up time ranged between 12 and 79 months. Partial component exchange had a higher rates of mechanical failure 10.3% versus 1.3% and 2.3 % (p=0.03) for complete and “drain and retain” groups respectively. (Figure 1) Similarly, partial component exchange had higher perioperative complications at 21.2% compared to complete replacement group 9.5% and “drain and retain” group 14.5% (p=0.022). However, the infection rate was similar among the three groups, 7.7%, 2.7% and 3.3% respectively (p= 0.301). (Figure 2) Conclusions Partial component exchange during IPP revision has higher rates of perioperative complication and future mechanical failure but has similar rate of infection compared to complete component replacement with or without “drain and retain” of original reservoir. Disclosure No.

(042) Reasons For and Time to Failure Associated with Inflatable Penile Prosthetics: A Multi-Center, High, Volume Experience

Abstract Introduction Despite technological advancements in the composition material, pump design, and infection retardant coatings, inflatable penile prosthetics (IPPs) remain prone to mechanical failure due to pump malfunction and/or fluid loss. Objective We aim to distinguish IPP component failure etiologies at the time of device replacement and/or repair between the two most common manufacturers: American Medical Systems/Boston Scientific (BSCI) and Coloplast (CP). Methods We performed an IRB approved, retrospective chart review of two private, high volume IPP surgeon revision and virgin cases (CPT codes 54405, 54408 and 54410) from January 2018 to May 2023. Mechanical revision indications were stratified by manufacturer and component location (pump, tubing, cylinder, and reservoir). Non mechanical revision cases were excluded (planned upsizing, patient dissatisfaction, herniation without replacement, impending erosion/eroded, crossover, and infection). Other exclusions included missing data (reason for failure, device type, op note, patient specific data, and/or prior institution operative details). Results Between the two surgeons, we identified a total of 646 cases during the study period. 120 were revision IPP cases, 66 of which, met inclusion criteria (57 BSCI and 9 CP). Of the BSCI mechanical inflatable penile prosthetic failures, 24/57 (42%) were due to cylinder rupture, 5/57 (9%) were due to tubing leaks, 3/57 (5%) were associated with reservoir perforation, 5/57 (9%) were due to cylinder aneurysm, and 20/57 (35%) were due to pump failure. Coloplast device mechanical failure was predominantly due to tubing fracture 7/9 (77.8%) while reservoir rupture and cylinder aneurysm each were 1/9 (11.1%). Between manufacturers, cylinder rupture and pump failure were more common in BSCI devices (25/57 vs 0/9, p=0.036; CI 95%) and (21/57 vs 0/9, p=0.064; CI 90%). While tubing fracture was more common in CP devices (5/57 vs 7/9, p=0.002; CI 95%). Cylinder aneurysm and reservoir rupture did not significantly differ between manufacturers. Similarly, log rank analysis illustrates similar time to mechanical failure between BSCI and CP (median 48 vs 41months respectively, p=0.277; CI 95%). Conclusions BSCI and CP device time to failure appears to be similar; this was also shown in recent published literature. BSCI pump failure appears to be greater than the previously described rate of 2% during their recall period from 2018-2020 and they fail significantly more than CP devices. BSCI devices most commonly fail due to cylinder rupture then other component failure. CP devices fail most commonly due to tubing rupture and this adds to the prior published literature. Further, multi-center studies are needed to validate these findings. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast and Boston Scientific Consultant.

Long-term outcomes of left atrial appendage closure with or without concomitant pulmonary vein isolation:a propensity score matching analysis based on CLACBAC study

BackgroundThe combined procedure of left atrial appendage closure (LAAC) with concomitant pulmonary vein isolation (PVI) has demonstrated its efficacy and safety. However, there is still a lack of comparative investigations regarding the long-term benefits of the combined procedure when compared to LAAC alone. Our study aims to assess the long-term outcomes of combined procedure of LAAC with concomitant PVI in comparison with a propensity matched LAAC alone group.MethodsPropensity score matching (PSM) was employed to rectify covariate imbalances, resulting in the inclusion of 153 comparable patients from the initial cohort of 333 non-valvular atrial fibrillation (AF) patients. Clinical outcomes, encompassing thrombotic events, major cardiocerebrovascular adverse events (MACCE), re-hospitalization due to cardiovascular disease (CVD), and atrial tachycardia (AT), were juxtaposed between the two groups. Bleeding events and peri-device complications, such as residual flow, device-related thrombus, and device replacement, were also compared. Additionally, a patients group underwent PVI alone was included for comparing AF recurrence rates between the PVI alone group and the combined group.ResultsFollowing PSM, 153 patients (mean age 70.3 ± 8.9, 62.7% men) were included, with 102 undergoing the combined procedure and 51 undergoing LAAC alone. No significant differences were found in baseline characteristics between the two groups. The mean follow-up time was 37.6 ± 7.9 months, and two patients were lost to follow-up in the combined procedure group. Thrombotic events were observed in 4 (7.8%) patients in the LAAC alone group and 4 (4.0%) in the combined group (Log-rank p = 0.301). The proportion of patients experiencing MACCE, re-hospitalization due to CVD, and AT between the two groups was comparable, as were bleeding events and peri-device complications. Among patients from the combined procedure group without AF recurrence, a significant difference was noted in prior-procedure left ventricular ejection fraction (LVEF) and LVEF at the 12th month after the procedure (57.2% ± 7.1% vs. 60.5% ± 6.5%, p = 0.002).ConclusionThe concomitant PVI and LAAC procedure did not increase procedure-related complications, nor did it confer significant benefits in preventing thrombotic events or reducing other cardiovascular events. However, the combined procedure improved heart function, suggesting potential long-term benefits.

Lateral Compression Manipulation: A Simple Approach for Sizing Taller-Than-Wide Intracranial Aneurysms with the Woven EndoBridge Device.

The Woven EndoBridge (WEB) system has established itself as a safe and effective option for managing wide-neck bifurcation aneurysms. Addressing aneurysms with a greater height than width using conventional WEB-sizing methods has proved ineffective due to the inherent configuration of the devices. To overcome this limitation, we propose an intuitive approach that involves swapping the width and height dimensions of the aneurysm to determine the appropriate WEB size. A retrospective analysis was conducted on patients undergoing WEB embolization at a single neuroscience center from March 2013 to February 2023. Twenty-five eligible aneurysms were identified, with the height dimension exceeding the width by an average of 2.33 mm (ranging from 1.4 to 4.5 mm). Of these, 20 cases adhered to the recommended sizing technique, resulting in a 100% success rate of adequate occlusion (14/20 complete occlusion, 6/20 proximal recess filling). In contrast, the outcomes for the remaining 5 cases that did not follow the proposed sizing method were less favorable (P < .05). Among these, 4 cases treated with undersized WEBs showed neck remnants during follow-up, and 1 patient who received an oversized WEB required device replacement during the same procedure. The simple sizing method we proposed for treating taller-than-wide aneurysms has demonstrated promising results, allowing the WEB system to address twice the original size range of treatable aneurysms. Further research with a larger sample size is recommended.

Model‐based digital twins of medicine dispensers for healthcare IoT applications

SummaryHealthcare applications with the Internet of Things (IoT) are often safety‐critical, thus, require extensive testing. Such applications are often connected to smart medical devices from various vendors. System‐level testing of such applications requires test infrastructures physically integrating medical devices, which is time and monetary‐wise expensive. Moreover, applications continuously evolve, for example, introducing new devices and users and updating software. Nevertheless, a test infrastructure enabling testing with a few devices is insufficient for testing healthcare IoT systems, hence compromising their dependability. In this paper, we propose a model‐based approach for the creation and operation of digital twins (DTs) of medicine dispensers as a replacement for physical devices to support the automated testing of IoT applications at scale. We evaluate our approach with an industrial IoT system with medicine dispensers in the context of Oslo City and its industrial partners, providing healthcare services to its residents. We study the fidelity of DTs in terms of their functional similarities with their physical counterparts: medicine dispensers. Results show that the DTs behave more than 92% similar to the physical medicine dispensers, providing a faithful replacement for the dispenser.

Unravelling staphylococcal small-colony variants in cardiac implantable electronic device infections: clinical characteristics, management, and genomic insights.

Staphylococcal small-colony variants (SCVs) are common in cardiac implantable electronic device (CIED) infections. This is the first retrospective and multi-case study on CIED infections due to staphylococcal SCVs, aiming to provide a theoretical basis for the clinical management of CIED and device-related infections caused by staphylococcal SCVs. Ninety patients with culture positive CIED infections were enrolled between 2021 and 2022. We compared the demographic and clinical characteristics of patients with and without SCVs and performed genomic studies on SCVs isolates. Compared to patients without SCVs, those with SCVs had a longer primary pacemaker implantation time and were more likely to have a history of device replacement and infection. They showed upregulated inflammatory indicators, especially higher NEUT% (52.6 vs. 26.8%, P = 0.032) and they had longer hospital stays (median 13 vs. 12 days, P = 0.012). Comparative genomics analysis was performed on Staphylococcus epidermidis wild-type and SCVs. Some genes were identified, including aap, genes encoding adhesin, CHAP domain-containing protein, LPXTG cell wall anchor domain-containing protein, and YSIRK-type signal peptide-containing protein. Staphylococcal SCVs affect the clinical characteristics of CIED infections. The process of staphylococcal SCVs adherence, biofilm formation, and interaction with neutrophils play a vital role.

AMPIE: Added Mass Passive Input Estimation - Acquiring Driving Points without Direct Excitation.

Experimental and hybrid substructuring allow the virtual analysis of complex structures that are rather represented by experimental models than simulations. Coupling the experimental models with other structures requires adequate driving points generally described by six degrees of freedom with three translations and rotations with forces and torques as inputs as well as translational and angular accelerations as outputs. However, the measurement of these driving points is challenging. In particular, experimentally acquiring all six inputs causes the main effort. For example, excitation devices that directly exert a torque are not widely applicable or three translational directions are not accessible. Therefore, adapter structures are frequently used in practice, which increase the experimental effort or can be impractical due to a lack of space and reachability. The proposed strategy is the replacement of active excitation devices, i.e. impulse hammers or shakers, on the driving points, by passive, rigid bodies, simply referred to as masses. Compared to the existing mass uncoupling method which is also based on this fundamental idea, the main improvement is a simplified notation that enables the incorporation of data from multiple masses and parametric state-space systems. The main finding is that the proposed strategy is suited to estimate driving point dynamics that allow to predict the effect of assembled structures on channels that were not used in the estimation of the driving point, indicating the physical relevance of the estimated dynamics.

Speech perception in patients submitted to cochlear reimplantation.

To analyze the performance of auditory speech perception (PF) after cochlear implant (CI) replacement surgery and associations with age, times of use of the first CI, deprivation, recovery and use of the second device. The retrospective study analyzed the medical records of 68 participants reimplanted from 1990 to 2016, and evaluated with PF performance tests, considering as a reference, the greater auditory capacity identified during the use of the first CI. Also analyzed were: Etiology of hearing loss; the reasons for the reimplantation; device brands; age range; sex; affected ear; age at first implant; time of use of the first CI, deprivation, recovery and use of the second device. The analyzes followed with the Chi-Square and Spearman, Mann-Whitney and Kruskal-Wallis tests (CI=95%; p≤0.05; Software SPSS®.v22). Most were children with hearing loss due to idiopathic causes and meningitis. Abrupt stoppage of operation was the most common cause for device replacement. Most cases recovered and maintained or continued to progress in PF after reimplantation. Adults have the worst recovery capacity when compared to children and adolescents. The PF capacity showed a significant association (p≤0.05) with: age at first implant; time of use of the first and second CI. Periodic programming and replacement of the device when indicated are fundamental for the maintenance of auditory functions. Being young and having longer use of implants represent advantages for the development of speech perception skills.

Unanticipated subcutaneous ICD end-of-service due to premature battery depletion and occurrence of lead fracture: A single centre experience

The use of subcutaneous ICDs (S-ICD) is growing over years despite increasing alerts on premature battery depletion (PBD) and lead fractures leading to unanticipated device replacements. In our single-centre study including 192 patients, per year analysis demonstrated that incidence of PBD is higher than previously reported with overall greatest battery replacement requirements around the fifth year of follow-up. The underlying issue appears to be limited to old series devices, but only a longer follow-up will clarify the real impact of this phenomenon on patient outcomes. PBD is an underestimated S-ICDs issue and if the hereby demonstrated trend were to be confirmed in latest device series, this would bring significant concerns to patient safety and huge economic expense to health system.

Safety and efficacy of cerliponase alfa in children with neuronal ceroid lipofuscinosis type 2 (CLN2 disease): an open-label extension study

Cerliponase alfa is a recombinant human tripeptidyl peptidase 1 (TPP1) enzyme replacement therapy for the treatment of neuronal ceroid lipofuscinosis type 2 (CLN2 disease), which is caused by mutations in the TPP1 gene. We aimed to determine the long-term safety and efficacy of intracerebroventricular cerliponase alfa in children with CLN2 disease. This analysis includes cumulative data from a primary 48-week, single-arm, open-label, multicentre, dose-escalation study (NCT01907087) and the 240-week open-label extension with 6-month safety follow-up, conducted at five hospitals in Germany, Italy, the UK, and the USA. Children aged 3-16 years with CLN2 disease confirmed by genetic analysis and enzyme testing were eligible for inclusion. Treatment was intracerebroventricular infusion of 300 mg cerliponase alfa every 2 weeks. Historical controls with untreated CLN2 disease in the DEM-CHILD database were used as a comparator group. The primary efficacy outcome was time to an unreversed 2-point decline or score of 0 in the combined motor and language domains of the CLN2 Clinical Rating Scale. This extension study is registered with ClinicalTrials.gov, NCT02485899, and is complete. Between Sept 13, 2013, and Dec 22, 2014, 24 participants were enrolled in the primary study (15 female and 9 male). Of those, 23 participants were enrolled in the extension study, conducted between Feb 2, 2015, and Dec 10, 2020, and received 300 mg cerliponase alfa for a mean of 272·1 (range 162·1-300·1) weeks. 17 participants completed the extension and six discontinued prematurely. Treated patients were significantly less likely than historical untreated controls to have an unreversed 2-point decline or score of 0 in the combined motor and language domains (hazard ratio 0·14, 95% CI 0·06 to 0·33; p<0·0001). All participants experienced at least one adverse event and 21 (88%) experienced a serious adverse event; nine participants experienced intracerebroventricular device-related infections, with nine events in six participants resulting in device replacement. There were no study discontinuations because of an adverse event and no deaths. Cerliponase alfa over a mean treatment period of more than 5 years was seen to confer a clinically meaningful slowing of decline of motor and language function in children with CLN2 disease. Although our study does not have a contemporaneous control group, the results provide crucial insights into the effects of long-term treatment. BioMarin Pharmaceutical.

“Real-world” analysis of battery longevity of implantable cardioverter-defibrillators: an in-depth analysis of a prospective defibrillator database

BackgroundThere is a lack of evidence regarding contemporary implantable cardioverter-defibrillator (ICD) battery longevity. Our aim was to assess battery longevity in ICDs in a real-world setting.MethodsRetrospective cross-sectional single center study of a prospectively collected database of consecutive patients who underwent ICD implantation from January 2010 to December 2015. Clinical data and battery longevity of all manufacturers were collected.ResultsA total of 351 patients (84.6% males, mean age of 61 ± 12 years) were included in the study (292 VVI; 6 VDD; 53 DDD). All manufacturers (Abbott, Biotronik, Boston, Medtronic and Microport) were equally represented in the study (p = 0.110). Median battery longevity was 10.8 years (11 years for VVI and 8.5 for DDD). After a follow-up time of 5 years, 98% of VVI and DDD were still in service (vs. industry-projected longevity of 98%). During this time, 89 patients (25.4%) underwent device replacement − 69 patients (77.5%) due to battery depletion, 6 patients due to infection, 3 patients due to dysfunction and 13 patients due to upgrade to CRT-D. Patients with Medtronic or Biotronik ICDs had a greater probability of being replaced earlier due to battery depletion (Biotronik HR 6.87, 95% CI 2.54–18.58, p < 0.001; Medtronic HR 6.08, 95% CI 2.45–15.06 p < 0.001).ConclusionsVVI and DDD ICD battery longevity matched industry-projected longevity after 5 years of follow-up. Medtronic and Biotronik ICDs appeared to have an earlier battery depletion. Further randomized studies are required to ensure optimal care.

Inflammation-induced subcutaneous neovascularization for the long-term survival of encapsulated islets without immunosuppression.

Cellular therapies for type-1 diabetes can leverage cell encapsulation to dispense with immunosuppression. However, encapsulated islet cells do not survive long, particularly when implanted in poorly vascularized subcutaneous sites. Here we show that the induction of neovascularization via temporary controlled inflammation through the implantation of a nylon catheter can be used to create a subcutaneous cavity that supports the transplantation and optimal function of a geometrically matching islet-encapsulation device consisting of a twisted nylon surgical thread coated with an islet-seeded alginate hydrogel. The neovascularized cavity led to the sustained reversal of diabetes, as we show in immunocompetent syngeneic, allogeneic and xenogeneic mouse models of diabetes, owing to increased oxygenation, physiological glucose responsiveness and islet survival, as indicated by a computational model of mass transport. The cavity also allowed for the in situ replacement of impaired devices, with prompt return to normoglycemia. Controlled inflammation-induced neovascularization is a scalable approach, as we show with a minipig model, and may facilitate the clinical translation of immunosuppression-free subcutaneous islet transplantation.

Discontinuation of cardiac implantable electronic device therapy after transvenous lead extraction.

Patients with cardiac implantable electronic devices (CIEDs) may no longer be eligible for continued therapy. The study aimed to assess the circumstances under which CIED reimplantation may not be necessary after transvenous lead extraction (TLE). A retrospective analysis of 3646 TLE procedures was performed with assessment of indications for device reimplantation. Reimplantation was not performed immediately after TLE in 169 (4.6%) and, in long-term follow-up, in 146 (4.0%) of patients. No further need for CIED reimplantation was mostly associated with establishment of stable sinus rhythm (2.4%), conversion of sinus node dysfunction to chronic atrial fibrillation (AF; 1.4%), or improvement in left ventricular ejection fraction (LVEF) (0.9%). Independent prognostic factors were in the pacing groups: LVEF (odds ratio [OR], 1.03; 95% confidence interval [CI], 1.01-1.05; P <0.001), AF (OR, 3.8; 95% CI, 2.4-15.7; P <0.001), patients' age during first CIED implantation (OR, 0.97; 95% C, 0.96-0.98; P <0.001), and New York Heart Association (NYHA) class (OR, 0.616; 95% CI, 0.43-0.86; P <0.01); in the cardioverter-defibrillator group: LVEF (OR, 1.06; 95% CI, 1.04-1.09; P <001). Non-reimplanted patients had more complex procedures and more frequent complications, but survival after TLE was better in this group of patients. Reassessment of the need for continuation of CIED therapy should be considered in all patients following lead extraction and also before planned device replacement as TLE delay increases implant duration, complexity, and procedural risk. The predictors of non-reimplantation are a younger age during the first CIED implantation, lower NYHA class, presence of AF, and higher LVEF in pacemaker carriers, and, in the defibrillator group, only higher LVEF. A decision not to reimplant does not negatively affect the long-term prognosis.

Multimodality Quantification of Thrombus Deposition in Extracorporeal Membrane Oxygenation (ECMO); Correlating Oxygenator Computed Tomography Imaging, Electron Microscopy and Histology to Clinical Outcomes

Introduction: Extracorporeal membrane oxygenation (ECMO) is essential for supporting cardiopulmonary function in critically ill patients, However, ECMO incurs thrombogenic risks due to activation of coagulation factors and blood cells by the biomaterial surfaces. This leads to complications such as frequent device replacement and systemic embolization despite the use of anticoagulation, suggesting additional mechanisms contribute to medical device-associated thrombosis. We propose that the geometry of the ECMO oxygenator significantly influences the structure and extent of clot formation and stability. To investigate this, we employed quantitative imaging and histologic techniques for a high-resolution, three-dimensional analysis of clot morphology in ECMO components, aiming to enhance our understanding of clot formation mechanisms, correlate these observations to clinical outcomes, and develop effective mitigation strategies. Methods: We developed a prospective study in which patients consented to the collection of blood samples, used ECMO components, and collection of relevant clinical variables. Computed tomography (CT) images were acquired using an Inveon microCT. H&amp;E stains, scanning electron microscopy (SEM), and CT images were processed through the Dragonfly software to accomplish a 3D visualization and analysis of clot composition. Clinical demographics and ECMO characteristics were recorded for each patient. Results: Digital photographs of used oxygenators are displayed in figure (A). Through CT scans, we quantified clot formation of distinct densities across the layers of the ECMO oxygenator (D). The results were able to quantify intraoxygenator thrombosis with high fidelity (27.65%, 14.56%, and 26.35% of the available membrane area was thrombosed across three representative oxygenators). Using a frontal CT scan to investigate clot formation identified five layers of varying structures across the intended path of blood flow (B). Clot formation was observed in layer 4 and layer 5, in which thrombosis occluded up to 12.2% of the layer on average. The overall ranking of clot formation under hemodynamic performance changes for all five layers was as follows: layer 5 &amp;gt; layer 4 &amp;gt; layer 1 = layer 2 &amp;gt;&amp;gt; layer 3. The use of anticoagulation at the time of ECMO decannulation significantly reduced the content of clot formation (P&amp;lt;0.0001). We then correlated digital biomarkers from imaging with thrombus composition. Detailed histological examination (HE) and SEM was undertaken on dismantled oxygenators (B &amp; C). We focused on thrombi at the interfaces and within the hollow fibers of the oxygenator. SEM and HE staining illustrated increased thickness, length, and density of fibrin structures in the thrombi from layer 5 to layer 4, whereas the numbers of platelets and cells decreased. Overall, layer 5 exhibited the most diverse types of thrombi, including blood cell-rich, platelet-rich, and fibrin-rich clots. We also observed aligned clots and significant clot formation in the hollow fiber area of layer 4, reflecting the geometry of the specific layer. Discussion: This pilot study examined the potential for imaging-based modalities to evaluate device associated thrombosis ex vivo, correlating these imaging findings to direct observations of thrombus composition and location. This methodology provides a platform to investigate ECMO device failure, identifying the key locations within select oxygenators where local device modification may be of most benefit. Future research will prioritize designing membrane oxygenator properties to minimize thrombus deposition, and will allow us to incorporate the use of serial imaging endpoints in future clinical trials evaluating medical device-associated thrombosis.

2438. Positive Cerebrospinal Fluid Cultures from Intraventricular Reservoirs for CLN2 Patients: One Institution's Experience

Abstract Background Enzyme replacement therapy (ERT) with cerliponase alfa (Brineura) has been shown to slow progression of milestone deterioration in Neuronal Ceroid Lipofuscinosis Type 2 (CLN2), an inherited neurodegenerative lysosomal storage disorder. Brineura must be administered intraventricularly every 2 weeks, necessitating the placement of ventricular reservoirs and requiring frequent access. Traditionally, positive cerebrospinal fluid (CSF) cultures are managed with device replacement and antibiotic treatment. We sought to establish which circumstances might allow for careful observation without device removal. In this study, we report our single-institution experience with clinical outcomes of positive CSF cultures in 16 CLN2 patients over 6 years. Methods We retrospectively reviewed a cohort of 16 patients with CLN2 disease who had ventricular reservoirs placed for ERT administration. At each ERT infusion, CSF was collected by sterile technique and cultured by both thioglycolate broth and agar plate. Epidemiologic and microbiologic data, symptomatology, total antibiotic days, removal and replacement of ventricular reservoir, hospital length of stay, and mortality were analyzed for each patient. Results In our cohort, 11 of 16 patients (69%) had at least one positive CSF culture (Fig 1). Of the 11 with positive cultures, only 3 had their device removed and replaced for a positive culture with concurrent antibiotic treatment at our center, and 2 patients subsequently have been treated with prophylactic antibiotics at infusions (Fig 2). Out of 1401 total CSF cultures, 64 (4.56%) were positive. The most common organism grown was Cutibacterium acnes, which typically grew in only broth culture (82%), suggesting low bacterial burden (Fig 3). The other 7 patients with positive cultures remained asymptomatic with no intervention required. Conclusion At our institution, we have found that in asymptomatic patients with frequently accessed ventricular reservoirs, positive CSF culture with low virulence skin flora was common, and rarely required intervention. This strategy reduced the risks of invasive surgery, prolonged antibiotic courses, and missed infusions. In the future, routine screening cultures in asymptomatic patients can be avoided. Disclosures Raymond Wang, MD, Biomarin Pharmaceutical: Advisor/Consultant|Biomarin Pharmaceutical: Grant/Research Support|Biomarin Pharmaceutical: equity interest Antonio C. Arrieta, MD, FIDSA, FPIDS, Astellas Pharma Global Development, Inc.: Advisor/Consultant|Astellas Pharma Global Development, Inc.: Grant/Research Support|Astellas Pharma Global Development, Inc.: Honoraria|Cumberland Pharmaceutical: Grant/Research Support|IDbyDNA: Advisor/Consultant|IDbyDNA: Grant/Research Support|Melinta: Grant/Research Support|Merck: Advisor/Consultant|Merck: Grant/Research Support|Nabriva: Grant/Research Support|Paratek Pharmaceuticals: Grant/Research Support|Pfizer, Inc: Advisor/Consultant|Pfizer, Inc: Grant/Research Support|Roche/Genentech: Grant/Research Support|The Medicine Company: Grant/Research Support

Cassandra speaks: a case series of unanticipated subcutaneous ICD premature battery depletion in a single-centre experience

Abstract Background Subcutaneous ICDs (S-ICD) are a valuable option in sudden cardiac death prevention. The main advantage over conventional transvenous ICDs is the absence of intravascular hardware for patients without the need for cardiac stimulation, resynchronization therapy or anti-tachycardia pacing. The claim of reduced lead-related complications has on the contrary been challenged by recent warnings of unexpected lead fracture. Moreover, concerns related to premature battery depletion (PBD) leading to unanticipated device replacement are increasing. Purpose To evaluate retrospectively the incidence of unanticipated S-ICD premature battery depletion in a single-centre experience. Method 168 consecutive patients implanted with S-ICD from February 2015 to November 2022 in our tertiary cardiology centre were included in this study. 4 patients moved to other sites and were thus lost to follow-up, leaving a total of 164 patients. PBD was defined as the occurrence of battery depletion requiring generator replacement earlier than 60 months post-implantation in the absence of therapy being delivered, or as a result of manufacturer recommendations. Results Most patients were implanted for primary prevention (101 patients, 60%). The main aetiology was hypertrophic cardiomyopathy (47 patients, 28%), followed by arrhythmogenic (35, 21%) and dilated idiopathic cardiomyopathy (24, 14%). Mean age and left ventricular ejection fraction at baseline were 46±18yrs and 51±16%, respectively. Over a total follow up period of 44±25 months, at 58±17 months following implantation 19 (11,6%) patients needed early replacement due to PBD, while 2 (1.2%) patients had lead fracture after respectively 41 and 26 months, for a total of 12,8% of patients with system-related complications. In addition to those patients requiring early replacement due to PBD or lead fracture, two underwent S-ICD extraction due to infection. Analysis of freedom from unanticipated PBD per year of implantation showed higher rates in years 2016 and 2017, with 67% and 27% of all implanted patients, respectively (Figure 1). Conclusions In this study, the incidence of PBDs appear to be higher than reported in literature though confined to a limited device series. However, if on the contrary the trend should remain remarkably high, that would not only endanger patients health due to repeated replacements, but also pose a huge economic burden to health systems.

Percutaneous removal and replacement of a novel percutaneous interspinous device.

Objective: The aim of this study is to explain the technique used for removing and replacing a novel percutaneous interspinous device (PID).Procedure: Three male patients, with a mean age of 66years (range 62-72), were included in the study due to displacement (N = 2) or misplacement (N = 1) of the novel PID. This occurred after a mean of 23.3 ± 10.5 days from the initial placement (range 13-34) at the L4-L5 level (N = 1) and L3-L4 level (N = 2). Following the removal of the PID, four new devices were implanted.Conclusion: The novel PID can be safely removed either immediately after its placement during the procedure or after a certain period of days or months from its implantation. The removal procedure can be performed percutaneously under imaging guidance, by closing the four retractable wings, using the same instrumentation as utilized during the initial implantation.