Support Devices Research Articles

Transcapsular scleral fixation of the standard capsular tension ring and in-the-bag intraocular lens implantation for severely subluxated lenses.

To present a technique of transcapsular scleral fixation of the standard capsular tension ring (CTR) through equatorial capsulotomy and in-the-bag intraocular lens (IOL) implantation in subluxated lenses. This retrospective consecutive case series included patients with subluxated lenses by more than 180 degrees who underwent lens extraction, transcapsular scleral fixation of the standard CTR through equatorial capsulotomy, in-the-bag IOL implantation and with at least 6mo follow-up. Preoperative and postoperative best corrected visual acuity (BCVA), intraocular pressure (IOP), complications, and postoperative IOL tilt and decentration were recorded. Nine eyes of 7 patients with a mean follow-up of 11.0±3.7mo were included in this study. The BCVA was significantly improved from 0.64±0.22 logMAR preoperatively to 0.21±0.19 logMAR postoperatively (P<0.001). The IOP was within the normal range postoperatively. The mean tilt of the IOL was 4.30°±2.31° (range, 1.0° to 8.9°) and the mean decentration of the IOL was 0.37±0.12 mm (range, 0.14 to 0.50 mm). No visually threatened intraoperative and postoperative complications were detected during the follow-up period. This is a safe and effective surgical technique for managing patients with severely subluxated lenses. It has achieved favorable outcomes with fewer surgical manipulations and less need for advanced capsular support devices.

Curricular Self-management for patients on ventricular assist device support decreases depression: A multicenter randomized controlled trial.

Utilization of ventricular assist device (VAD) support in patients with end-stage heart failure is well advanced. Recent studies emphasize the need to develop and evaluate evidence-based psychosocial support interventions for patients following VAD implantation. A national, multi-center study in four established German heart centers was initiated. An evidence-based VAD curriculum was developed; a randomized controlled trial evaluated the impact of the interprofessional intervention over time. Primary combined endpoint was the occurrence of adverse events (thromboembolic events, driveline infections, bleeding, rehospitalization, and death); secondary endpoints were psychosocial outcomes (anxiety, depression [HADS], quality of life [QoLVAD], social support [FSoZu], and self-management [SELMA]). A total of 140 patients were randomized block-wise to intervention (IG n = 70) or control (CG n = 70). Center-effects were considered. Instruments were completed at four time points (T0-T3). At baseline, intervention group (IG) patients were 19% female (control group [CG] 19%; p = 0.982); 58 ± 11 years. (CG 58 ± 11 years.; p = 0.966); 80% were implanted electively (CG 79%; p = 0.968). No significant difference in primary endpoint was found between IG versus CG (p > 0.05). For secondary endpoints, mixed linear regression revealed a significant reduction in depression scores in IG compared to CG (est. 1.18; 95% CI -2.17 to -0.18; p = 0.021). Clinically significant reductions in anxiety were greater in IG patients between T0 and T3 (IG 51.9%; CG 40.7%); increased anxiety was reported in 3.7% IG (11.1% CG). Mixed linear regression analyses favored IG (all >0.05) for QoL, social support, and self-management. A comprehensive curricular VAD intervention has potential to decrease depression levels and improve psychosocial outcomes of patients on VAD support.

Beyond conventional rehabilitation: an observational study on RYSEN body weight supported gait training in individuals after stroke and spinal cord injury

Purpose The RYSEN body weight support device enables multidirectional overground gait training and can be combined with augmented reality (RYSEN-AR). The aim of this study was to investigate differences in training goals, intensity and acceptance between RYSEN, RYSEN-AR and conventional gait training (CGT) during rehabilitation. Materials and Methods Eleven individuals after stroke (60.1 ± 13.4 years) and eleven individuals with SCI (66.5 ± 13.2 years) performed CGT, RYSEN and RYSEN-AR as part of their rehabilitation program. Heart rate and trunk accelerometry data were collected to assess training intensity. Patients rated their confidence in balance control, level of conscious movement processing and training experiences using questionnaires. Therapists reported their intended training goals. The (interaction) effects of modality and group on these outcomes were assessed using linear mixed-effects models. Results Training intensity in terms of heart rate and trunk accelerometry did not differ between modalities. Confidence in balance control was higher during RYSEN-AR than during CGT (p = 0.004). The level of conscious movement processing did not differ between modalities. Training goals did not considerably differ between modalities overall. RYSEN and RYSEN-AR training were well-accepted among patients and therapists. Conclusions In current practice, there is limited distinction in terms of training intensity and goals between RYSEN and RYSEN-AR training relative to CGT. Further research, guideline development and implementation strategies are needed to use the RYSEN to its full potential in rehabilitation practice.

Developing a Desktop-Based OSI Model Interactive Learning Application Using VB.NET

This research focuses on developing a desktop-based learning application to help students understand the concept of OSI Model using VB.NET. The purpose of this application is to provide interactive learning media that can facilitate understanding of the seven layers of OSI and the process of data transmission in the network. This research applies the Waterfall method, starting from requirements analysis, system design, implementation, testing, to the operation and maintenance stage. The development results show that this application is equipped with structured learning material features, evaluation quizzes, and user-friendly navigation. The application trial shows performance in accordance with the design, where the quiz evaluation feature is able to provide an accurate assessment of student understanding. In conclusion, this learning application can be an innovative solution in the delivery of OSI Model material, with further development opportunities that include the addition of interactive simulations and support for mobile devices.

Risk Factors for Hearing Screen Failure in a Single Family Room Neonatal Intensive Care Unit.

To determine hearing screen outcomes and identify clinical and environmental risk factors for hearing screen failure in very preterm infants at a level IV single family room (SFR) neonatal intensive care unit (NICU). We conducted a retrospective study of infants <33wks gestational age admitted to a level IV SFR NICU who survived to discharge and had automated auditory brainstem response results available. Demographics, antenatal and postnatal factors, and respiratory support modes and their duration were collected from the electronic medical record. Of 425 eligible infants with documented hearing screen results, 353 (83%) passed and 72 (17%) failed the hearing screen [unilateral, N= 44 (61%); bilateral, N= 28 (39%)]. Compared to infants who passed the hearing screen, infants with hearing screen failure were lower gestational age and birthweight, male sex, were screened at later postnatal and postmenstrual ages, had lower 1 and 5 min Apgar scores, longer duration of furosemide therapy, early hypotension, IVH≥ Grade 3, and BPD at 36 weeks PMA. Infants with hearing screen failure experienced longer exposures to invasive and non-invasive respiratory support. Heated, humidified, high flow nasal cannula >2LPM exposure was significantly longer in infants with bilateral hearing screen failure (18.4±18.4 d) compared to duration in infants who passed (7.4±12.8 d) and those with unilateral failure (9±13 d), (mean ± SD, p<0.001). In the final logistic model, IVH ≥Grade 3 (OR 3.22, 95% CI 1.15-8.98, p=0.026) and BPD (OR 2.27, 95% CI 1.25-4.11, p=0.007) were the factors with greatest risk for hearing screen failure. We speculate that the association of BPD with hearing screen failure may be mediated, in part, by chronic noise exposure, including from respiratory support devices. Attention to hearing protection in at-risk infants during respiratory support may mitigate the risk of hearing loss.

A Latent Cardiomyocyte Regeneration Potential in Human Heart Disease.

Cardiomyocytes in the adult human heart show a regenerative capacity, with an annual renewal rate of ≈0.5%. Whether this regenerative capacity of human cardiomyocytes is employed in heart failure has been controversial. We determined cardiomyocyte renewal in 52 patients with advanced heart failure, 28 of whom received left ventricular assist device support. We measured the concentration of nuclear bomb test-derived 14C in cardiomyocyte genomic DNA and performed mathematical modeling to establish cardiomyocyte renewal in heart failure with and without LVAD unloading. We show that cardiomyocyte generation is minimal in end-stage heart failure patients at rates 18 to 50× lower compared with the healthy heart. However, patients receiving left ventricle support device therapy, who showed significant functional and structural cardiac improvement, had a >6-fold increase in cardiomyocyte renewal relative to the healthy heart. Our findings reveal a substantial cardiomyocyte regeneration potential in human heart disease, which could be exploited therapeutically.

Abstract 4136694: Impact of left ventricular support devices on myocardial and pulmonary recovery in patients with cardiogenic shock treated with venoarterial extracorporeal membrane oxygenation

Background: Venoarterial-extracorporeal membrane oxygenation (VA-ECMO) is used to treat cardiogenic shock. However, retrograde arterial perfusion from the femoral artery can increase left ventricular (LV) afterload, resulting in LV distention which may hamper myocardial recovery and worsen pulmonary congestion. An intra-aortic balloon pump (IABP) can mitigate LV afterload, and Impella (Abiomed, Danvers, MA) can directly unload LV pressure. This study aimed to evaluate the efficacy of LV support devices during VA-ECMO in patients with cardiogenic shock. Methods: We retrospectively collected data from 213 consecutive patients treated with VA-ECMO due to cariogenic shock at our institution between January 2013 and December 2023. Patients were categorized as either receiving VA-ECMO alone or VA-ECMO with an LV support device. The LV support device was characterized as VA-ECMO with IABP or Impella. Data were analyzed for mortality, weaning from VA-ECMO, and changes in pulmonary congestion using the congestion score index (CSI), which is a semi-quantitative approach to pulmonary congestion based on a 6-zone evaluation of chest radiography, scoring each zone from 0 (no congestion) to 3 (intense pulmonary edema). Results: In this study, 95 patients received VA-ECMO alone, whereas 118 patients received an LV support device (101 VA-ECMO with IABP and 17 VA-ECMO with Impella). LV support devices improved weaning from VA-ECMO (odds ratio, 3.09 [95% confidence interval (CI), 1.75–5.55]; p&lt;0.0001) whereas there was no difference in IABP versus Impella cohorts. Compared with VA-ECMO alone, patients with VA-ECMO with an LV support device had better survival at 30 days (OR, 3.04 [95% CI, 1.73–5.43]; p&lt;0.0001). The rate of survival to discharge was better in VA-ECMO with an LV support device versus VA-ECMO alone (hazard ratio, 2.51 [95% CI, 1.72–3.65]; p&lt;0.0001). The evaluation of pulmonary congestion using the CSI revealed that congestion significantly improved in VA-ECMO with Impella (changes of CSI: 1.86 to 1.36) but not in VA-ECMO with IABP (1.80 to 1.96) and VA-ECMO alone (1.94 to 2.14). Conclusion: An LV support device may be associated with reduced mortality and increased success in weaning off VA-ECMO in patients with cardiogenic shock. Impella may be particularly effective in reducing pulmonary congestion.

Abstract 4115816: Enhancing Cardiogenic Shock Management: Insights from MCS utilization and Patient Outcomes

Cardiogenic shock (CS) remains a challenge with high mortality rates despite advances in treatment modalities. This study investigates the utilization and impact of mechanical circulatory support (MCS) devices, including intra-aortic balloon pump (IABP), Impella, and Extracorporeal Membrane Oxygenation (ECMO) on patient outcomes in CS management. A retrospective analysis was performed using National Inpatient Sample data (2017 to 2019). Inclusion criteria included patients aged ≥18 years with primary diagnosis of CS using ICD10(R570). Multivariate regression analysis was used to assess MCS duration, mortality, length of stay (LOS), and costs. Among 462,685 included patients, 38% were female, with a mean age of 66 years. Majority were White (67%), followed by Black (16.5%), and Hispanic (9%). IABP was utilized in 13% of cases, Impella in 6%, and ECMO in 0.9%. No significant difference was observed in MCS placement between weekdays vs weekends. However, weekend admissions showed higher mortality rates with an odd ratio (OR) of 1.06(p &lt;0.00, CI 1.03-1.09), particularly among females OR 1.25(p&lt;0.00, CI 1.22 – 1.289). Urban non-teaching hospitals exhibited highest mortality rate, followed by Urban teaching. ECMO was associated with highest mortality OR 2.08(p &lt; 0.00, CI 1.93-2.82), followed by Impella OR of 1.47 (p &lt; 0.00, CI 1.37 – 1.59), and IABP OR 0.723 (p &lt; 0.00, 0.685-0.765). LOS was lowest in Impella group, followed by IABP, while ECMO showed non-significant LOS increase. Mean total charge varied among MCS groups with ECMO being highest. The findings highlight several important aspects of CS management. Elevated mortality rates during weekend admissions suggest potential disparities in care access or delivery, necessitating investigation and interventions to ensure consistent quality of care throughout the week. Increased mortality among females, variations across different hospital settings, impact of MCS devices on LOS and costs emphasize the need for tailored approaches to enhance patient outcomes and resource utilization efficiency.

Abstract 4129945: Risk of stroke for AMI treated with temporary mechanical circulatory support: ten-year data from National Inpatient Sample

Objectives: The aim of this study was to assess the risk of stroke for temporary mechanical circulatory support (tMCS) device treated acute myocardial infarction (AMI). Background: Data are limited regarding risk of stroke for temporary mechanical circulatory support (tMCS) device treated acute myocardial infarction (AMI). Methods: The national inpatient sample database was analyzed to identify adults who were hospitalized for AMI between 2012 and 2021, hospitalizations were grouped based on the temporary mechanical circulatory support device. Study design: In the final cohort, there are 8,272,163 (96.0%) weighted hospitalizations treated without tMCS, 265,870 (3.1%) with Intra-Aortic Balloon Pump (IABP) alone, 59,240 (0.7%) with Impella alone, and 16,225 (0.2%) with Extracorporeal Membrane Oxygenation (ECMO) used during the hospitalization. Results: The overall stroke rates for patients who treated without tMCS, IABP alone, Impella alone, and ECMO group were 3.41%, 3.46%, 4.51%, and 13.34% respectively. Specifically, the rates of ischemic stroke for these groups were 2.95%, 3.12%, 3.96% and 10.11% respectively. The rates for hemorrhagic stroke were 0.68%, 0.55%, 0.81%, and 4.90% for the same groups. In the stepwise forward Cox regression analysis, the adjusted OR (aOR) of ECMO use for overall stroke was 3.04 (95%CI [2.66-3.48]), followed by Impella only use with an aOR of 1.79 (95%CI [1.61-2.00]), and atrial fibrillation (aOR 1.34, 95%CI [1.31-1.38]). The subgroup analysis revealed that hospitalization with age younger than 50 years old, those without hypertension, and those presented with ST-elevation myocardial infarction are at particularly high risk of stroke for ECMO treated AMI. Conclusion: This ten years AMI hospitalizations analysis revealed that ECMO and Impella treatment associated with increased risk of both ischemic and hemorrhagic stroke. Particularly for those younger than 50, those without hypertension, and those presented with ST-elevation myocardial infarction. However, treatment with IABP alone does not increase the risk of stroke.

SURG-23. ESTABLISHMENT OF AN APPROPRIATE GLIOMA SURGERY SYSTEM CONSIDERING MOLECULAR AND FUNCTIONAL BOUNDARIES

Abstract Gliomas are invasive tumors and cannot be cured by surgery. But surgical removal has also been proven to affect treatment outcomes. Recent advances in molecular diagnostics have identified IDH mutations, especially in lower grade gliomas, allowing the identification of so-called molecular boundaries. It is conceivable that expanded resection to the molecular border may improve treatment outcome. On the other hand, extended resection may be incompatible with functional preservation. In such cases, it is also important to consider that the impact of surgery on treatment outcome has also been proven to vary by glioma genotype. While total resection has a significant prognostic impact on survival in astrocytomas with IDH mutations, the impact on survival in oligodendrogliomas that are sensitive to chemoradiotherapy and, conversely, in high-grade tumors without IDH mutations is lower than in the former. Therefore, it is important to determine the extent of removal after considering the tumor type. In general, various surgical support devices such as surgical navigation systems, fluorescent diagnosis using 5ALA, intraoperative electrophysiological monitoring, awake functional brain mapping, and intraoperative MRI are applied during glioma surgery. In addition to these, we have developed a surgical system that also focuses on tumor subtypes by introducing preoperative tumor type prediction using AI imaging and intraoperative rapid genetic diagnosis. We have further developed intraoperative rapid genetic diagnosis to identify genetic mutations around the tumor, enabling the detection of molecular boundaries. It is now possible to remove as much as possible, considering the molecular boundary, while paying sufficient attention to preservation of brain functions. Gliomas are intractable diseases, but their treatment outcomes have steadily improved over time. We are now in an era of a tailor-made surgery based on a variety of data. Implementing “appropriate surgical procedures” we aim at further improvement of treatment outcomes.

Outcomes of Older Patients With Cardiogenic Shock Using the Impella Device - Insights From the Japanese Registry for Percutaneous Ventricular Assist Device (J-PVAD).

Aging has progressed in several regions of the world with more older patients experiencing acute cardiovascular disease. Impella is a percutaneous potent circulatory support device associated with substantial cost and potential device-related complications. We analyzed the Japanese nationwide registry, encompassing consecutive patients with cardiogenic shock using Impella. Among 5,718 patients treated between 2020 and 2022, we compared older patients (≥75 years) with younger patients. The primary outcome was the Kaplan-Meier estimated 30-day mortality, and the secondary outcome was Impella-related complications. The median age of the 5,718 patients was 69 (58-77) years, and 1,807 (31.6%) were older, with smaller body mass index, frequent acute coronary syndrome, and infrequent myocarditis. Comorbidities were frequently observed in older patients with a higher ejection fraction and less frequency of extracorporeal membrane oxygenation. Older patients had a higher 30-day mortality than younger patients (38.9% vs. 32.5%; P<0.0001). The 30-day mortality was statistically equivalent among older subsets (75-79 vs. 80-84 vs. ≥85 years). Device-related complications similarly occurred similarly among the older subsets, except for a modest increase in cardiac tamponade and limb ischemia. Older age, body mass index, myocarditis, prior arrhythmia, shock severity, renal and hepatic impairment, and limb ischemia were associated with 30-day mortality. The selected older patients using Impella exhibited modestly higher 30-day mortality with similar safety profiles. A longer follow up and optimal patient selection are important.

Improving the hemocompatibility of centrifugal mechanical circulatory support devices at low flow rates.

An innovative solution has been recently proposed for the treatment of heart failure with preserved ejection fraction (HFpEF), using a centrifugal mechanical circulatory support (MCS) device. We sought firstly to assess the hemocompatibility of the proposed device. HFpEF treatment requires the blood pump to operate at low blood flow rate (0.05-0.5 L/min). Given high blood trauma expected in these conditions, we sought secondly to investigate design improvements in order to reduce this risk. Computational fluid dynamics was used to analyze the blood fluid filled within the centrifugal pump and to estimate the blood trauma due to its operation. This assessment is based on the computation of integrated quantities such as the hemolysis index and the turbulent dissipation energy. The hemolysis index associated with the present device is comparable to the figures from HVAD. With the proposed pump, for instance, an index of 0.0036 is obtained at 1 L/min and 3000 rpm. Using thinner blades for the impeller allows a 12% reduction of the hemolysis index in average, while reducing its diameter leads to an index 2.8 folds lower at 0.5 L/min. The present investigation shows the promising hemocompatibility of our centrifugal pump. Concerns about very high hemolysis generated at low flow rates could be overcome by reducing the impeller diameter. Experimental validations are planned to support our findings.

Hematologic and biochemical reference values for anesthetized juvenile German crossbred farm pigs

Juvenile crossbred pigs are widely used for acute and chronic animal testing due to their anatomical and physiological resemblance to humans. They are particularly prevalent in preclinical cardiovascular research, including studies investigating extracorporeal resuscitation and mechanical circulatory support devices. However, the availability of comprehensive laboratory reference values is limited. In a single-center study at the University Medical Center Freiburg, Germany, the hematologic and biochemical laboratory values of anesthetized healthy juvenile German crossbred farm pigs were determined. Blood samples were collected at the beginning of surgical procedures, either arterially or venously. Females and males were compared, and correlation with body weight was assessed. In total, 268 animals (weight 57.8 ± 12.4 kg) were included, thereof 180 castrated males (55.2 ± 7.7 kg) and 79 females (63.6 ± 18.3 kg). There were significant differences between males and females in 11 of 45 parameters and a moderate correlation between body weight and creatinine (R = 0.41, p < 0.001). The reference intervals and insights into sex and body weight correlations enhance the utility of healthy juvenile German crossbred farm pigs in translational research, providing a robust reference for future studies.

Nanomedicine-based strategies for the treatment of vein graft disease.

Autologous saphenous veins are the most frequently used conduits for coronary and peripheral artery bypass grafting. However, vein graft failure rates of 40-50% within 10 years of the implantation lead to poor long-term outcomes after bypass surgery. Currently, only a few therapeutic approaches for vein graft disease have been successfully translated into clinical practice. Building on the past two decades of advanced understanding of vein graft biology and the pathophysiological mechanisms underlying vein graft disease, nanomedicine-based strategies offer promising opportunities to address this important unmet clinical need. In this Review, we provide deep insight into the latest developments in the rational design and applications of nanoparticles that have the potential to target specific cells during various pathophysiological stages of vein graft disease, including early endothelial dysfunction, intermediate intimal hyperplasia and late-stage accelerated atherosclerosis. Additionally, we underscore the convergence of nanofabricated biomaterials, with a particular focus on hydrogels, external graft support devices and cell-based therapies, alongside bypass surgery to improve local delivery efficiency and therapeutic efficacy. Finally, we provide a specific discussion on the considerations, challenges and novel perspectives for the future clinical translation of nanomedicine for the treatment of vein graft disease.

Safety and efficacy of an innovative external support device for de novo arterio-venous fistula creation: a French bicentric experience.

The aim of this study was to evaluate the safety and efficacy of VasQTM, a permanent extravascular nitinol vascular support device, implanted around the anastomosis of de novo arteriovenous fistulas (AVF), in consecutive patients. This was a French prospective bicentric study. All patients with an indication for creation of a distal or proximal end to side AVF performed by supervised trainee were eligible. Follow-up was performed clinically and by Duplex scan at 6 weeks and 6 months post fistula creation. Primary endpoint was functional maturation at 6 weeks defined as successful use for dialysis via 2-needle cannulation in dialysis patients or a flow rate of ≥600 mL/min and a target vein diameter ≥6 mm for pre-dialysis patients. Overall functional success for dialysis patients was assessed as well. Between March and November 2022, 21 patients received the VasQTM device and were followed for an average of 165 days. Median age was 61. Eleven patients (52%) were on dialysis at the time of implantation. AVFs were created with distal radial (N.=8), proximal radial (N.=5), brachial cephalic (N.=4) or brachial basilic (N.=4) arteries with 100% technical success . Functional maturation at 6-weeks was achieved in 81% (17/21). Functional success was 80% (12/15) with unassisted functional success of 67% (10/15) at 6 months for patients requiring dialysis at that time point. Two reoperations were performed within the device, one thrombectomy and one angioplasty, both were successful. Freedom from access-related interventions occurred in 71% (15/21) of the study population at 6-months. This study demonstrates that the VasQTM AVFs achieved high rates of maturation at 6-weeks, without the need to modify standards of care. VasQTM can successfully assist in achieving excellent results at the introduction of the device to a new center.

Breaking Down Cardiogenic Shock: An Analytical Reflection on the DanGer-SHOCK and ECLS-SHOCK Trials

Mechanical circulatory support (MCS) devices, particularly the microaxial flow pump (mAFP), have gained traction in managing cardiogenic shock (CS) in patients with acute myocardial infarction (AMI). However, trials like DanGer-Shock and ECLS-Shock have reported differing outcomes, making it challenging to draw definitive conclusions. To explore this further, we conducted a comparative analysis of the 30-day and 6-month mortality rates from the DanGer-Shock and ECLS-Shock trials, examining differences in patient populations and risk profiles. The goal was to determine whether these differences could explain the conflicting outcomes or if the benefits observed in the DanGer-Shock trial were directly attributable to the mAFP strategy. One key finding is that, despite similar control group mortality rates, the intervention group in DanGer-Shock demonstrated a notably lower mortality rate at both 30 days and 6 months compared to the ECLS trial, with an absolute difference of about 8%. This benefit is not due to inherent risk differences but is instead attributed to the Impella-based strategy. Compared to standard care, mAFP data revealed a 7% mortality reduction at 30 days, which grew to 12.7% at 180 days, highlighting the long-term effectiveness of the mAFP strategy in maintaining hemodynamic stability and improving survival. These results suggest that, in CS management, the DanGer unloading strategy, when combined with percutaneous coronary intervention (PCI), plays a significant role in improving long-term survival through early intervention and ventricular unloading, independent of control group factors. Further research is needed to confirm the broader applicability of this approach in different patient populations.

Magnetoactive elastomer-based dynamic urethral support device for stress urinary incontinence

Stress urinary incontinence (SUI) is the involuntary leakage of urine in response to increased intra-abdominal pressure during episodes of exertion. A common treatment method for SUI is sling implantation underneath the urethra to provide support. Most current sling procedures, however, cannot adjust urethral tension postoperatively. To address this limitation, we designed a soft magnetoactive elastomer (MAE) device capable of changing shape in response to moderate magnetic fields. To ensure shape change after fibrotic scar tissue encapsulation, MAE devices were embedded in agar gels with different stiffnesses, and their shape change was studied in response to up to 200 mT magnetic fields. A simple in vitro model of the lower urinary tract was designed to study device performance. Flow time was measured as a function of pressure in the simulated bladder as the model system leaked before and after activating sling with a hand-held magnet. MAE devices embedded in agar gel (100 kPa) in hammock-like configuration achieved 4.7% ± 1.1% change in height. Devices with silica-coated magnetic particles showed minimal loss in mass after two weeks in accelerated oxidative (2.36% ± 1.55%) and hydrolytic (0.58% ± 0.25%) conditions. Placing a sling under the model urethra provided urethral support; thus, increasing its resistance to flow. Normalized flow time significantly reduced from 1.56 ± 0.18 to 1.11 ± 0.16 when magnetic field was applied, indicating urethral support modulation at 60 cm-H2O. This dynamic sling, powered externally with physiologically safe magnetic fields, allowed for urethral support modulation in a model of the lower urinary tract. Statement of significanceStress urinary incontinence (SUI) affects up to half the adult women during their lifetime, and slings are commonly used to treat severe cases. While sling implantation is minimally invasive and offers moderate to high cure rates, long-term sling complications, such as urine retention, remain a significant concern. Available adjustable SUI devices often require invasive surgeries, implantable electronics, and multiple mechanical components, increasing the overall invasiveness. Here, we report a proof of concept for using shape-morphing biomaterials to fabricate a dynamic device that can provide continence support and be triggered to change shape, enabling complete voiding. Such a dynamic device may prevent many complications associated with traditional slings and improve quality of life for women suffering from severe SUI.

Impact of HF etiology on the sustainability of favorable response after LVAD weaning: A VAD Wean Registry analysis

Abstract Background A subset of heart failure (HF) patients can experience significant improvement of their cardiac structure and function while on left ventricular assist device (LVAD) support. Purpose We sought to investigate the impact of HF etiology on the durability of cardiac improvement and favorable outcomes after LVAD weaning. Methods We studied 324 HF patients enrolled in the international multicenter VAD Wean Registry who received a durable continuous-flow LVAD and underwent device support weaning (Figure 1). Indications for VAD weaning included: structural/functional cardiac improvement meeting institutional criteria for "myocardial recovery" (responders) or LVAD-related complications accompanied by variable degrees of cardiac improvement (partial responders). Patients were divided into seven categories based on HF etiology: ischemic cardiomyopathy (CM) (n=30), post-myocarditis CM (n=65), peripartum CM (n=53), valvular CM (n=12), chemotherapy-induced CM (n=14) and idiopathic CM (n=150). The primary outcome was 2-year survival free of transplant or LVAD re-implantation. The secondary outcome was the LVEF, measured by echocardiography at 3, 6, 12 and 24 months post-LVAD weaning. Results Patients with idiopathic, peripartum and post-myocarditis CM had higher rate of 2-year survival free of transplant or LVAD re-implantation compared to patients with chemotherapy-induced CM (Figure 2-Panel A) (p-values: 0.009, 0.004, 0.001, respectively). Patients with post-myocarditis CM were also more likely to achieve the primary outcome compared to those with ischemic CM (ICM) (p-value, 0.009). The LVEF changes over time are depicted in the Figure 2-Panel B. Conclusions In this multicenter analysis the etiology of HF appears to impact the durability of favorable response after LVAD weaning. The degree of reverse remodeling achieved before VAD weaning and its impact on the durability of response in different HF etiologies warrants further investigation in studies with larger patient population and power.

STEMI SHOCK outcomes with SCAI classification

Abstract Background Patients with ST-elevation myocardial infarction who develop cardiogenic shock (STEMI-SHOCK) face significantly increased risk compared to those without shock. Mechanical circulatory support (MCS) devices are commonly utilized in STEMI-SHOCK patients, but the benefits of MCS remain uncertain. This study aims to apply the Society for Cardiovascular Angiography and Interventions (SCAI) shock classification system to STEMI-SHOCK patients, examining outcomes and identifying subgroups that may benefit from MCS. Purpose Our study assessed SHOCK severity in STEMI-SHOCK patients using the updated 2021 SCAI-SHOCK classification system and determined survival at various endpoints (30 days, 1 year, and 3 years), along with other outcomes such as vascular access complications and major adverse cardiac events, based on the severity class. Methods Patients with angiograms and indications of STEMI-SHOCK between 2012 and 2021 admitted to Liverpool Hospital Australia, were included after adjudication they had STEMI-SHOCK. Angiograms were eligible for adjudication if they met criteria for both STEMI and SHOCK. Each patient underwent individual adjudication by three researchers to confirm STEMI-SHOCK status. Patients were followed from the time of the first SHOCK diagnosis until censoring at the last follow-up. Data were retrieved from electronic and paper-based patient records. The primary outcome was 30-day survival, and secondary outcomes were 1-year and 3-year survival. Results The SCAI stages of 160 (Estimated 220) STEMI-SHOCK patients were determined, with 17 in Stage A, 39 in Stage B, 53 in Stage C, 25 in Stage D, and 26 in Stage E. Worse SCAI stages were associated with significantly lower 30-day, 1-year, and 3-year survival. No difference in survival between the time periods 2013-2015 and 2018-2021 was found. An eGFR &amp;lt; 60 millilitres/minute/1.73 meters^2 (hazard ratio [HR] 3.41; 95% confidence interval [CI] 1.18 – 9.92, p=0.024) and lactate greater than 4.15 millimoles/liter (HR 6.48; 95% CI [2.84 – 51.64], p=0.001) at shock were associated with lower 30-day and 3-year survival. Patients in the SCAI C subgroup treated with an IABP had significantly higher 1-year (p=0.001) and 3-year (p=0.001) survival compared to those not treated with an IABP. Conclusion The SCAI classification system successfully predicted short and long-term survival in STEMI-CS patients, with worse stages having progressively worse outcomes. No improvement in survival outcomes was observed in the overall SCAI C-E group of patients treated with mechanical support. However, patients in the SCAI C subgroup of SHOCK treated with mechanical support showed a statistically significant improvement in survival outcomes compared to those treated without mechanical support. Further studies with adequate sample sizes are required to investigate sub-populations of SCAI classes that may benefit from MCS devices.

Echocardiographic evaluation of ventricular performance in VA-ECMO weaning: results from a observational monocentric prospective study

Abstract Background Although temporary mechanical circulatory support (MCS) devices are increasingly used in the management of cardiogenic shock (CS), several open question regarding the kind of support and timing of institution/weaning remains open. Echocardiography is widely applied to drive the weaning process and decision although there are no standardized protocols for the trial nor accordance on the parameters to apply. Purpose We sought to evaluate the overall accuracy of echocardiographic indices in predicting successful weaning from VA ECMO in patients with CS. Specifically, we tested total isovolumic time (tIVT), an index of ventricular performance, and longitudinal function (MAPSE) on top of the commonly used parameters (left ventricular ejection fraction, LVEF; left ventricular velocity time integral, LV VTI; TAPSE; right ventricular S’ at tissue Doppler imaging, RV S’). Methods Monocentric prospective study on adults receiving VA-ECMO due to refractory CS and/or cardiac arrest (CA) from 2012 to 2020. Echocardiography was performed at VA-ECMO placement and during the weaning trials. Weaning trials were performed daily, starting 48 hours after VA-ECMO institution, when patients were hemodynamically stable: mean arterial pressure &amp;gt;65 mmHg, no or minimum adrenergic support (vasoactive inotropic score &amp;lt;10), heart rate &amp;lt;110 bpm, lactate &amp;lt;2 mmol/L, and no signs of respiratory distress. Weaning trials were performed with a stepwise decrease of VA-ECMO blood flow until reaching 1 or 1.5 L/min under adequate anticoagulation. Successful weaning was defined as removal of VA-ECMO with no requirement for further MCS in the following 30 days. Results 76 patients were enrolled (23.8% female, 54.2±10.6 years-old), 52.6% due to CA. Median duration of VA-ECMO was 58 hours; 47 (61.8%) had intra-aortic balloon pump (IABP) inserted upfront. In-hospital mortality was 62.4% overall, 40% for CS without CA. 6 of the 32 weaned patients died for multiorgan failure due to septic shock. The baseline echocardiographic parameters associated with successful weaning were (table): stroke volume &amp;gt;13.9 mL (p 0.002), tIVT &amp;gt;23.6 min/sec (p 0.053), LV VTI &amp;gt;6.6 cm (p&amp;lt;0.001), MAPSE &amp;gt;6.15 mm (p 0.001), TAPSE &amp;gt;11 mm (p 0.023), RV S’ &amp;gt;10 cm/s (p 0.012). LVEF did not reach the statistical significance. Figure shows Kaplan-Meier analysis on echocardiographic indices collected at time of cannulation (panel A) and during the last weaning trial (panel B). Conclusions Echocardiography is pivotal in defining cardiac recovery and monitoring the weaning trial. Indices reflecting ventricular performance and delivered flow from LV were associated with weaning success both at VA-ECMO institution and throughout the weaning trials. Considering the known limitations of LVEF (heart rate, loading and left ventricular dyssynchrony dependence), tIVT and MAPSE should be introduced in the standard evaluation of patients in the acute setting.TableFigure