Support Devices Research Articles

The Application of Mechanical Circulatory Support in Special Conditions

Abstract Special conditions, though not typically associated with cardiovascular distress, may be considered for treatment with temporary mechanical circulatory support (tMCS) devices. Such non-classical examples of cardiovascular compromise include trauma, sepsis, and peripartum cardiomyopathy, among others, and may require urgent treatment with a tMCS device for hemodynamic stabilization and tentatively saving the patient’s life. In this section, examples of the use of tMCS in several special circumstances is presented to garner awareness for such conditions, which have previously been overlooked or even considered contraindications, and highlight the benefit of tMCS devices during treatment of these patients and the need for more research into these circumstances.

Diagnosis and Management of Patients with Fulminant Myocarditis

Abstract Fulminant myocarditis (FM) is a progressive and severe form of acute myocarditis, complicated by cardiogenic shock. The clinical presentation and etiologies of FM is often heterogeneous, making it difficult to diagnose. Irrespective of how FM presents, it rapidly evolves to hemodynamic deterioration and requires prompt treatment to stabilize. As such, the use of mechanical circulatory support (MCS) devices has emerged as a critical intervention to achieve hemodynamic support, early unloading, systemic perfusion and to prevent multiorgan dysfunction in patients with FM. Although scientific societies have proposed recommendations and management pathways, due to the heterogeneity in FM there remains a lack of clarity in the diagnostic pathway and selection of MCS device for this young patient population. This review provides an updated and integrated overview of the diagnostic flow and important clinical considerations when managing patients with FM.

Managing the Acute Cardiac Functional Crisis: A Comprehensive Review of Cardiogenic Shock Management Strategies

Abstract Cardiogenic shock (CS) is a life-threatening condition defined by the heart's inability to adequately pump blood to meet metabolic demands, leading to systemic hypoperfusion and insufficient tissue oxygenation. Despite treatment advancements, CS continues to carry high morbidity and mortality rates, especially when it follows acute myocardial infarction (AMI). Various expert groups and scientific societies have proposed recommendations and management pathways, each contributing unique insights yet sometimes overlooking important clinical considerations. This mini-review provides an updated, integrated overview of distinct CS scenarios, including ischemic, non-ischemic, and post-cardiotomy categories, and their respective treatment strategies. Additionally, this review explores management approaches that underscore the importance of early detection of inflammatory markers in non-ischemic CS and targeted therapeutic interventions for each CS subtype. Specifically, the role of pharmacological treatments is examined alongside the relevance and timing of mechanical circulatory support (MCS) devices. A deeper understanding of the pathophysiology and tailored management pathways for each CS type may enable clinicians to improve interventions and enhance survival and recovery in patients with CS.

The role of temporary mechanical circulatory support in acute on chronic heart failure

Abstract Heart failure remains a leading cause of morbidity and mortality worldwide, with acute heart failure or cardiogenic shock requiring rapid intervention to prevent fatal outcomes. Advances in temporary mechanical circulatory support devices (tMCS) have revolutionized the management of advanced heart failure, offering temporary, durable, and individualized support options. This manuscript reviews the pathophysiology and clinical presentation of acute heart failure, the role of multidisciplinary Heart Teams, and the growing importance of structured care networks in managing complex cases of heart failure. We explore the strategic deployment of tMCS in acute settings, device options, implications for patient outcomes, and current challenges in the field. This manuscript emphasizes the importance of team-based approaches and underscores the potential of tMCS devices in stabilizing patient haemodynamics, bridging to recovery or definitive therapy, and improving survival in patients facing high-risk heart failure.

Feasibility of a novel back support device to improve spine stability and muscular activity during trunk flexion: A prospective cross-sectional study with healthy controls and low back pain subjects - preliminary.

Low back pain is a prevalent global condition often challenging to address due to the absence of a definitive diagnosis in over 80% of cases. Manual lifting, common in many work environments, contributes to low back pain due to lumbar spine stresses, and existing assistive technologies like abdominal belts and exoskeletons have limitations in managing low back pain effectively. This paper presents a novel back support device designed to generate abdominal compression during flexion activities, potentially enhancing lumbar stability through increased intra-abdominal pressure. The study involved 14 participants with chronic non-specific low back pain and 18 gender-matched healthy controls doing controlled movement tests with and without the support device. Results suggest that the back support device increased intra-abdominal pressure in both groups during various functional tasks, more notably in active flexion and lifting tasks (up to +43%). The device also contributed to decreasing lumbar range of motion during guided flexion (-18 to -37%, except at the lumbosacral junction in the low back pain group), emphasizing its potential impact in limiting excessive spinal movement. Muscle activity assessments revealed decreased activation during active flexion and lifting movements while wearing the device, suggesting the possibility to assist trunk stabilization without the corresponding antagonistic muscle activation and associated compressive load on the spine. These effects could help workers to maintain their activities in the workplace and help workers suffering from low back pain to gradually reintegrate work or physical activities, contributing to better overall management of back health.

Mechanical circulatory support for complex, high-risk percutaneous coronary intervention.

The evidence base evaluating the use of mechanical circulatory support (MCS) devices in complex, high-risk percutaneous coronary intervention is evolving from a small number of randomised clinical trials to incorporate an amassing body of real-world data. Due to both the growing incidence of the procedures and the limitations of the evidence, there is wide variability in the use of MCS, and the benefits are actively debated. The goal of this review is to perform an integrated analysis of randomised and non-randomised studies which have informed clinical and regulatory decision-making in contemporary clinical practice. In addition, we describe forthcoming studies that have been specifically designed to advance the field and resolve ongoing controversies that remain unanswered for this complex, high-risk patient population.

Abstract TMP91: Acute Stroke Characteristics, Treatment and Outcomes in Children on Mechanical Circulatory Support

Introduction: Mechanical circulatory support (MCS) carries a high risk of neurologic complications, with estimates of arterial ischemic stroke (AIS) to be between 5 and 30%. We report our cohort of children on Ventricular Assist Device (VAD) or Extracorporeal Membrane Oxygenation (ECMO) support who suffered AIS, and describe stroke treatment and outcomes in this high-risk population. Methods: The Stanford Pediatric Stroke Registry retrospectively and prospectively enrolled children aged 30 days-22years admitted to our quaternary care pediatric hospital between 2007-2024 with confirmed AIS on neuroimaging. Demographic, clinical, radiographic, treatment and outcome data were collected via chart review and entered into a secure, HIPAA-compliant RedCAP database. Children on MCS at the time of stroke were compared with non-MCS patients and analyzed using descriptive statistics. Results: A total of 35/207 (16.9%) patients were identified as having an AIS while on MCS; demographics and clinical characteristics are shown in Table 1. Overall, MCS patients were younger and were more likely to have congenital or acquired heart disease than non-MCS patients. Stroke presentation, treatment and outcomes are shown in Table 2. Stroke symptoms were detected upon weaning sedation in the majority of MCS patients (37.1%), and clinical exam was confounded by paralysis or sedation in 82.9%. Over half of MCS patients had peri-procedural strokes, and stroke was detected within 24 hours in 45.8%. Large Vessel Occlusion (LVO) was detected in over half of MCS patients; however, less than a third underwent vessel imaging as part of their initial stroke neuroimaging. Intravenous thrombolysis was contraindicated in all MCS patients. Thrombectomy was performed on 2 MCS patients after ECMO decannulation and was not pursued for most MCS-LVO patients primarily due to large core or completed stroke (Figure 1). Mortality and morbidity were high in the MCS cohort, with 45.5% of MCS patients having an mRS of 5-6 on discharge, compared to 14.4% of non-MCS patients. Conclusions: Pediatric AIS on MCS carries a high risk of morbidity and mortality and can be challenging to recognize acutely, with the post-procedural period being particularly high-risk. Advanced neuroimaging and neuromonitoring may play an important role in earlier detection of stroke and eligibility for thrombectomy in this population.

Reducing Hospital-Acquired Pressure Injuries in a Cardiothoracic Intensive Care Unit.

Hospital-acquired pressure injuries are a significant patient safety concern. The Centers for Medicare & Medicaid Services tracks hospital-acquired pressure injuries as a patient safety indicator. Health care organizations with higher-than-expected rates may incur penalties. The pressure injury prevalence rate in a cardiothoracic intensive care unit was above the National Database of Nursing Quality Indicators benchmark. The current standard of care-use of the Braden scale for pressure injury risk assessment and the SKIN (surface, keep turning, incontinence care, and nutrition) care bundle-may not adequately address the needs of the intensive care unit population. In addition, cardiac patients present a special challenge because of their disease process and the mechanical support devices used to treat patients in cardiogenic shock, which place them at risk for the development of hospital-acquired pressure injuries. A performance improvement project was carried out in the cardiothoracic intensive care unit to reduce the prevalence and incidence of hospital-acquired pressure injuries. A preintervention convenience cohort was compared with a postintervention cohort. The intervention consisted of use of the Cubbin-Jackson scale, an intensive care unit-specific risk-assessment tool, with linked interventions to prevent pressure injuries. The preintervention and postintervention cohorts consisted of 102 patients each. The pressure injury prevalence and incidence rates decreased by 67.84% and 36.43%, respectively, from before to after the intervention. The use of an intensive care unit-specific risk-assessment tool with linked interventions to prevent pressure injury can help reduce hospital-acquired pressure injuries in an intensive care unit.

Mechanical circulatory support devices in acute left main disease: a multicenter study.

Mechanical circulatory support devices in acute left main disease: a multicenter study.

International Urogynecology Consultation Chapter3 Committee 1 - Pessary Management.

This manuscript is part of the International Urogynecological Consultation (IUC) on Pelvic Organ Prolapse (POP), Chapter 3, Committee 1 focusing on pessary management of POP. A narrative review was conducted by an international, multi-disciplinary group of clinicians working in the field of pelvic health following a search of the literature using the MeSH terms "pelvic organ prolapse" OR "urogenital prolapse" OR "vaginal prolapse" OR "uterovaginal prolapse" AND "pessary" OR "support device" OR "intravaginal device." Relevant studies, as determined after review using the Covidence manuscript review platform, were included. A total of 540 articles were reviewed, of which 313 were included for this narrative review. The reported pessary fitting success rate ranges from 41% to 96.6%, and the continuation of successful use rate varied from 21% to 97.7%. The most likely predictors of unsuccessful fitting trials were previous POP surgery, previous hysterectomy, short vaginal length, wide genital hiatus, and posterior compartment involvement. Following successful pessary placement in individuals with POP, vaginal bulge and pressure resolved in over 90%. A significant improvement in obstructive voiding was reported in 40-97% of participants, urinary urgency in 38%, urgency urinary incontinence in 29-77%, and stress urinary incontinence in 9-45%. Older age and women who can self-manage the pessary care or had family support were factors associated with pessary continuation. Common reasons reported for discontinuation included expulsion, vaginal pain/discomfort, unwillingness to continue, erosions, desire for surgery, bleeding, symptoms not improved with pessary, and incontinence. More serious complications (fistula, bowel obstruction, pessary impaction, and vaginal cancer) are rare, and occur usually in older women in whom pessary maintenance has been neglected. There is no high-quality evidence to guide pessary choice. The current literature lacks studies specifically focused on determining the role of preventative measures, i.e., estrogen, pessary type/material as regardsto pessary-associated complications (PACs). The review identified a lack of information about the relevant and required training and education (for healthcare professionals and patients) for pessary provision, use, and management. There is a considerable body of published work on the use of pessaries for POP, including effectiveness, factors associated with success and failure, and complications. However, there is a dearth of published literature regarding how pessary types are selected by providers, how providers are trained, what defines competency in pessary provision, and what constitutes appropriate patient education related to pessary use and management.

The experience of bodily image for patients with left ventricular assist device

IntroductionMechanical Cardiac Support and Left Ventricular Assist Devices (LVAD) have been demonstrated to prolong Heart Failure patients' survival and improve their quality of life. LVAD implantation has a considerable effect on patients' body image. Patients find it hard to accept the device as an extension of their body, especially the driveline. The study aimed to examine the relationships between anxiety and depressive symptoms, acceptance of illness, beliefs about pain control, and quality of life with body image among LVAD-implanted patients.MethodsThe cross-sectional study included 54 conveniently recruited patients who completed the Body Image Scale, SF-12, Acceptance of Illness Scale, Beliefs about Pain Control Questionnaire, NRS, HADS, and demographic and clinical data. Multiple regression analyses examined the associations between the research variable.ResultsThe mean Age of the participants was 59.64 (SD=9.63), and 96.3% were men. The mean scores were: Body Image Scale – 28.33 (SD=5,91); Acceptance of Illness Scale – 25.51 (SD=5.92); beliefs about pain control: internal factors – 15.85 (SD=4.96), the influence of physicians – 17.57 (SD=3.15), random events – 14.37(SD=3.32), NRS=2.80(SD=1.86), HADS anxiety – 5.33 (SD=4.12), HADS depression – 4.66 (SD=3.10), SF12MCS-45.49 (SD=6.48), SF-12PCS-41,33 (SD=6.48). The presence of anxiety and depressive symptoms and complications after LVAD significantly predicted low body image concerns.DiscussionHealthcare professionals should be aware of challenges regarding body image faced by LVAD-implanted patients and address related factors, especially anxiety and depression.

The impact of pre-transplant ventricular assist device support in pediatric patients with end-stage heart failure on the outcomes of heart transplantation—“a single center experience”

The impact of pre-transplant ventricular assist device support in pediatric patients with end-stage heart failure on the outcomes of heart transplantation—“a single center experience”

Ferroelectric and Optoelectronic Coupling Effects in Layered Ferroelectric Semiconductor-Based FETs for Visual Simulation.

Controlling polarization states of ferroelectrics can enrich optoelectronic properties and functions, offering a new avenue for designing advanced electronic and optoelectronic devices. Here, ferroelectric semiconductor-based field-effect transistors (FeSFETs) are fabricated, where the channel is a ferroelectric semiconductor (e.g., α-In2Se3). Multiple conductance states are achieved in α-In2Se3-based FeSFETs by controlling the ferroelectric polarization. The on/off current ratio (Ion/Ioff) is ≈105 with a dark current of ≈10-11A by applying a single positive gate voltage pulse. Moreover, the device shows excellent endurance and retention performance. In a further step, the carrier transports and corresponding physics mechanism in various polarization states are studied by using Kelvin probe force microscopy (KPFM) and optoelectronic measurements. Finally, the α-In2Se3-based FETs can be trained. It can recognize handwritten digit images from MNIST dataset with a successful recognition accuracy of ≈95.5%. This work provides a new design idea and theoretical support for advanced optoelectronic devices in the field of in-memory sensing andcomputing.

Intravascular lithotripsy in calcified left main coronary artery: Procedural success and 1-year clinical outcomes.

Intravascular lithotripsy (IVL) has an excellent efficacy and safety profile in the treatment of calcified coronary lesions during percutaneous coronary intervention (PCI). However, data regarding its use on left main (LM) lesions are still limited. We aimed to analyze the technical success and 1-year clinical outcomes in calcified LM lesions treated with IVL. Patients who underwent IVL from the ongoing prospective BENELUX registry were eligible for inclusion. Patients were divided into LM and non-LM groups based on the anatomical application of the IVL pulses. The primary technical endpoint was technical success, defined as the successful delivery of the IVL catheter across the target lesion, administration of IVL pulses without angiographic complications, and achieving a residual target lesion stenosis of less than 30 %. The primary safety endpoint was in-hospital major adverse cardiac events (MACE). The study included 509 patients (59 LM and 450 non-LM). Patients in the LM group were significantly older (79 years [75-82] vs. 73 years [68-81], p < 0.01). Left ventricular ejection fraction was slightly lower in the LM group (41 % [19-50] vs. 51 % [40-60], p = 0.053). Temporary mechanical circulatory support devices were more frequently used in the LM group, primarily as part of the "protected PCI" strategy (6.8 % in LM vs. 2.1 % in non-LM, p = 0.04). Technical success was comparable between the two groups (93.2 % in LM vs. 89.8 % in non-LM, p = 0.41). Cardiac death, MACE, and target vessel revascularization rates were also comparable at hospital discharge, 30 days, and 1-year follow-up. IVL in calcified LM lesions achieved comparable technical success and long-term clinical outcomes to non-LM lesions.

Venoarterial Membrane Oxygenation in Cardiogenic Shock Complicated from an Acute Myocardial Infarction: An Overview and Comprehensive Meta-Analysis.

Background: Cardiogenic shock remains a significant cause of mortality in patients with acute coronary syndrome, despite early interventions, such as coronary revascularization. Mechanical circulatory support devices, particularly venoarterial extracorporeal membrane oxygenation (VA-ECMO), are increasingly being utilized to address this issue. Limited randomized controlled trials (RCTs) exist to evaluate the efficacy of VA-ECMO in cardiogenic shock related to acute coronary syndrome. Methods: A meta-analysis was conducted to assess the effectiveness of VA-ECMO in adult patients with infarct-related cardiogenic shock. Trials were identified through database searches and selected based on specific inclusion criteria. The primary outcome was 30-day all-cause mortality, with secondary outcomes including bleeding and vascular complications. Results: A total of 24 studies met the inclusion criteria and were included in the meta-analysis, involving 4706 patients. The median age of the patients was 61.8 ± 4.1 years, with 76% of them being males. The analysis revealed that 30-day mortality rates for patients with cardiogenic shock receiving ECMO were still high, with a mortality of 63%. Vascular complications were identified as factors associated with a worse prognosis. Conclusions: The meta-analysis highlights the ongoing challenge of high mortality rates in cardiogenic shock patients despite the use of VA-ECMO. While VA-ECMO shows promise in providing circulatory support, further research is needed to explore ways to improve outcomes and reduce complications associated with the use of these devices. The complexity of patient management in cardiogenic shock cases underscores the need for a multidisciplinary approach to optimize treatment strategies and enhance patient outcomes.

Systemic Circulation in Advanced Heart Failure and Cardiogenic Shock: State-of-the-Art Review.

The integrative physiology of the left ventricle and systemic circulation is fundamental to our understanding of advanced heart failure and cardiogenic shock. In simplest terms, any increase in aortic stiffness increases the vascular afterload presented to the failing left ventricle. The net effect is increased myocardial oxygen demand and reduced coronary perfusion pressure, thereby further deteriorating contractile function. Although mechanical circulatory support devices should theoretically work in concert with guideline-directed medical therapy, cardiac resynchronization and inotropic and vasopressor agents designed to support myocardial performance and enhance left ventricle recovery, this does not always occur. Each therapy and intervention may result in vastly different and sometimes deleterious effects on vascular afterload. Although best described by a combination of both steady-state and pulsatile components, the latter is frequently overlooked when mean arterial pressure or systemic vascular resistance alone is used to quantify vascular afterload in advanced heart failure and cardiogenic shock. In this state-of-the-art review, we examine what is known about vascular afterload in advanced heart failure and cardiogenic shock, including the use of temporary and permanent mechanical circulatory support systems. Importantly, we outline 4 key components for a more complete assessment of vascular afterload. Unlike previous discussions on this topic, we set aside considerations of venous return and ventricular preload, as important as they are, to focus exclusively on the hydraulic load within the systemic circulation against which the impaired left ventricle must contract.

The Role of Impella in Cardiogenic Shock Complicated by an Acute Myocardial Infarction: A Meta-Analysis.

Background: Emerging evidence suggests the role of mechanical circulatory support (MCS) devices in the therapy of refractory cardiogenic shock (CS). However, largerandomized trials addressing the role of Impella in the therapy of infarct-associated CS are sparse. As such, evidence coming from comprehensive retrospective studies or meta-analyses is of major importance in order to clarify the role of the Impella device in this setting. Methods: Only clinical trials involving patients receiving Impella 2.5 and Impella CP for treatment of CS caused in terms of acute coronary syndrome (ACS) were included in this meta-analysis. The primary endpoint was 30-day mortality, with major bleeding and ischemic vascular complications serving as secondary endpoints. Results: A total of 18 observational retrospective studies (2617 patients with CS and Impella implantation) were included in this analysis. The mean age of the total participants was 64.7 ± 2.93 years. A mean mortality incidence of 45% was found between all included participants. The ischemia rate was in total 8.5 ± 4.4%, and the incidence of bleeding was 13.9 ± 5.6%. Conclusions: The 30-day mortality rate for patients with ACS-associated CS treated with Impella remains high. The high complication rates underline the importance of Impella use in only a very well-selected population of patients.

Implications of mechanical circulatory support devices in a pregnant woman with cardiogenic shock

Data on the use of mechanical circulatory support devices in pregnant women are limited. A 27-year-old woman at 27 weeks and 6 days of gestation was supported by three different mechanical circulatory support devices due to cardiogenic shock. She came into spontaneous labor, which was complicated by major hemorrhage at the cannulation site, fetal distress, and transverse position, requiring emergency cesarean section. The postpartum period was complicated by intra-abdominal bleeding and arterial occlusion of lower extremity. When using mechanical circulatory support devices in pregnant women, a multidisciplinary approach is recommended.

Mechanical circulatory support: when, how, and for whom.

Cardiogenic shock represents a critical condition in which the heart is unable to maintain adequate circulation leading to insufficient tissue perfusion and end-organ failure. Temporary mechanical circulatory support offers the potential to stabilize patients, provide a bridge-to-recovery, provide a bridge-to-decision, or facilitate definitive heart replacement therapies. Although randomized controlled trials have been performed in infarct-related cardiogenic shock and refractory cardiac arrest, the optimal timing, appropriate patient selection, and optimal implementation of these devices remain complex and predominantly based on observational data and expert consensus, especially in non-ischaemic shock. This review explores the details of 'when, how, and for whom' temporary mechanical circulatory support devices should be used, examining specific clinical scenarios, the mechanisms by which they operate, and the patient populations that may benefit. The review also highlights the many gaps in evidence and need for better understanding of the interaction between human biology and these devices.

Mechanical Circulatory Support in Patients Without Cardiogenic Shock Undergoing Percutaneous Coronary Intervention.

The use of mechanical circulatory support devices for high-risk percutaneous coronary intervention (PCI) has increased over the past decade despite limited data of benefit. We sought to examine the association between intravascular microaxial left ventricular assist device (LVAD) versus intra-aortic balloon pump use in patients without cardiogenic shock (CS) undergoing PCI. This retrospective study analyzed claims data from a large, insured population who underwent PCI without CS from April 1, 2016 to July 31, 2022. Using inverse probability treatment weighting, we assessed for the association between device type and clinical outcomes. The primary outcome was all-cause mortality. Secondary outcomes included stroke, bleeding, incident dialysis, repeat revascularization, and total health care costs during the index admission and at 30 days. We identified 2879 patients without CS who underwent PCI with either an intra-aortic balloon pump or microaxial LVAD. The mean±SD age was 68.2±12.5 years, and 27% (n=764) were women. After propensity weighting, intravascular LVAD use was not associated with a significant difference in either in-hospital (odds ratio [OR] 1.30 [95% CI, 0.88-1.91]; P=0.19) or 30-day mortality (OR, 1.19 [95% CI, 0.84-1.69]; P=0.33) compared with intra-aortic balloon pump use. Compared with those receiving an intra-aortic balloon pump, the mean total costs for the index admission ($96 716 versus $71 892; P<0.001) and at 30 days (+$16 671 [95% CI, $6639-$28 103]; P=0.001) were significantly higher in those receiving an intravascular LVAD. There was no significant association between device type and stroke, bleeding, incident dialysis, and repeat revascularization at any time point (all P>0.05). In patients without CS undergoing PCI, intravascular LVAD use was associated with higher costs but not associated with lower mortality. Randomized data are needed to improve device selection for patients without CS undergoing PCI.