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A stroke is a neurological disease that primarily causes paralysis. Besides paraplegia, all other types of paralysis affect the upper extremity. Advanced technologies, such as wearable devices and rehabilitation regimens, are also being developed to enhance the functional ability of a stroke person to grasp and release daily living objects. In this research, we developed a rehabilitation functional assist device combining a flexion and extension mechanism with suction cup technology (hybrid technology) to help post-stroke patients improve their hand grip strength in day-to-day grasping activities. Ten poststroke hemiplegia patients were studied to test the functional ability of the impaired hand by wearing and not wearing the device. The outcomes were validated by three standard clinical tests, such as the Toronto Rehabilitation Institute – Hand Functional Test (TRI-HFT), the Chedoke Arm Hand Activity Inventory (CAHAI-9), and the Fugl-Meyer Assessment (FMA) with overall score improvements of 14.5 ± 3.8–25 ± 2.2 (p = 0.005), 5.4 ± 2.8–10 ± 1.6 (p = 0.008), and 9.6 ± 2.6–17 ± 2.4 (p = 0.005) respectively. The p -value for each of the three evaluations was less than 0.05, indicating significantly improved results and the average feedback score of the participants was 3.8 out of 5. The proposed device significantly increased impaired hand functionality in post-stroke patients. The subjects could complete some of the grasping tasks that they could not grasp without the device. Clinical trial registration The Clinical Trial Registry of India approved the work CTRI/2022/02/040495 described in this manuscript. [ABSTRACT FROM AUTHOR]

Cardiac Muscle Training - A New Way of Recognizing and Supporting Recovery for LVAD Patients in the Pediatric Population During the weaning protocol, we collected clinical, laboratory (ABG, BNP, troponin, end-organ parameters, e.g., liver and kidney) and 2D echocardiographic data, as well as speckle tracking (ST), VTI measurements and RT3DE recordings of left ventricular enddiastolic (LVEDV) and endsystolic (LVESV), stroke volume (SV) and ejection fraction (EF). Conclusions Retraining a weakened heart may be a viable option for patients with heart failure on VAD therapy. Once the patient has been stabilised, individualised protocols should be established, tailored precisely to the patient's cardiac and clinical situation, even after prolonged VAD therapy. [Extracted from the article]

Objectives: Cancer-therapy-related heart failure (CTrHF) due to cardiotoxic drugs or radiation is a growing cause of end-stage heart failure. Limited knowledge is available concerning the use of continuous-flow left-ventricular-assist devices (cfLVAD) in this setting. Methods: The files of all 1334 patients who underwent cfLVAD implantation between December 2008 and December 2020 were screened for the cause of heart failure. All patients with CTrHF were included in the analysis. Results: A total of 32 patients with a median age of 58 years (IQR: 46–65) were included in the study; 15 (47%) were male. The median time from the first diagnosis of heart failure (HF) to cfLVAD implantation was 6 months (IQR 2–24), and from cancer treatment to cfLVAD implantation 40 months (IQR 5–144). Malignancies comprised non-Hodgkin lymphoma (n = 12, 37%), breast cancer (n = 9, 28%), sarcoma (n = 5, 16%), leukemia (n = 5, 16%), and others (n = 1, 3%). In 24 patients, chemotherapy included anthracyclines (others n = 2, unknown n = 6). Chest radiation was performed in 13 patients (39%). Moreover, 71% were classified as INTERMACS profile 1 or 2. The 30-day survival rate after LVAD implantation was 88%. Rethoracotomy was necessary in nine (29%), and a temporary right ventricular assist device in seven (21%) patients. The median survival was 29 months. There was no significant difference in survival or right HF between patients with CTrHF and a matched control group. Conclusions: CfLVAD implantation is feasible in high-risk patients with CTrHF with or without prior chest radiation. [ABSTRACT FROM AUTHOR]

Background: Extracorporeal cardiopulmonary resuscitation (eCPR) is a rapidly growing treatment strategy due to increasing survival rates in selected patients. Additional left ventricular mechanical unloading, using a transfemoral micro‐axial blood pump (Impella® Denver, Massachusetts, USA), might improve patients' outcomes. In this regard, we sought to investigate patients who suffered OHCA (out‐of hospital cardiac arrest) or IHCA (in‐hospital cardiac arrest) with subsequent eCPR via VA‐ECMO (veno‐arterial extracorporeal membrane oxygenation) and concomitant Impella® implantation based on survival and feasibility of ECMO weaning. Methods: From January 2016 until December 2020, 108 patients underwent eCPR at our institution. Data prior to eCPR and early outcome parameters were analyzed comparing patients who were supported with an additional Impella® (2.5 or CP) (ECMO+Impella®, n = 18) and patients without additional (ECMO, n = 90) support during V‐A ECMO therapy. The primary endpoint was in‐hospital mortality; secondary endpoints were, among others: ECMO explantation, need for hemodialysis, stroke, and need for blood transfusions. Results: Low‐flow time was significantly lower in the ECMO+Impella group (60 min vs. 55 min, p =.01). All‐cause mortality was significantly lower in the ECMO+Impella® group (82% vs. 56%, p =.01). The time of circulatory support was shorter in the ECMO cohort (2.0 ± 1.73 vs. 4.76 ± 2.88 p =.05). ECMO decannulation was significantly more feasible in patients with ECMO+Impella® (72% vs. 32%, p =.01). Patients treated with additional Impella® showed significantly more acute kidney injury with the need for dialysis (72% vs. 18%, p ≤.01). Conclusion: Concomitant Impella® support might positively influence survival and ECMO weaning in eCPR patients. Treatment‐associated complications such as the need for dialysis were more common in this highly selected patient group. Further studies with larger numbers are necessary to evaluate the clinical relevance of concomitant LV‐unloading in eCPR patients using an Impella® device. [ABSTRACT FROM AUTHOR]

Background: Heart failure predisposes to intracardiac thrombus (ICT) formation. There are limited data on the prevalence and impact of preexisting ICT on postoperative outcomes in left ventricular assist device patients. We examined the risk for stroke and death in this patient population.Methods and Results: We retrospectively studied patients who were implanted with HeartMate (HM) II or HM3 between February 2009 and March 2019. Preoperative transthoracic echocardiograms, intraoperative transesophageal echocardiograms and operative reports were reviewed to identify ICT. There were 525 patients with a left ventricular assist device (median age 60.6 years, 81.8% male, 372 HMII and 151 HM3) included in this analysis. An ICT was identified in 44 patients (8.4%). During the follow-up, 43 patients experienced a stroke and 55 died. After multivariable adjustment, presence of ICT increased the risk for the composite of stroke or death at 6-month (hazard ratio [HR] 1.82, 95% confidence interval [CI] 1.00-3.33, P = .049). Patients with ICT were also at higher risk for stroke (HR 2.45, 95% CI 1.14-5.28, P = .021) and death (HR 2.36, 95% CI 1.17-4.79 P = .016) at 6 months of follow-up.Conclusions: The presence of ICT is an independent predictor of stroke and death at 6 months after left ventricular assist device implantation. Additional studies are needed to help risk stratify and optimize the perioperative management of this patient population. [ABSTRACT FROM AUTHOR]

Abstract Aims Acute right heart failure (RHF) is a severe complication of right ventricular infarction. The management of acute RHF poses a number of challenges, such as providing haemodynamic support. Temporary circulatory support (TCS) may be required upon failing medical therapy. The ProtekDuo® dual lumen cannula provides a minimally invasive option for (TCS) through a groin‐free internal jugular vein approach. We present the largest patient series to date using the ProtekDuo® cannula as temporary right ventricular assist device (t‐RVAD) in RHF after acute myocardial infarction (MI). Methods and results From July 2016 to November 2019, 10 patients underwent t‐RVAD implantation for RHF following acute MI. Transthoracic and transoesophageal echocardiography were performed in all patients to assess cardiac function, with a particular focus on RV function. Cumulative 30‐day survival was 60%. Mean TAPSE was 6.4 ± 3.1 mm, mean fractional area change was 12.1 ± 4.2%, and mean right ventricular end diastolic area was 19.8 ± 2.7 cm2. Mean implantation time was 32.8 ± 8.3 min. Mean interval after first cardiac intervention was 4.6 ± 5.8 days. Mean t‐RVAD time was 10.0 ± 7.4 days with a significant reduction in central venous pressure 19.3 ± 2.7 vs. 8.2 ± 2.6 mmHg, P

Background: Inotrope score has been proposed as a marker of clinical outcome after adult heart transplantation (HTx) but is rarely used in practice. Methods: Inotrope score during the first 48 h after HTx was calculated in 81 patients as: dopamine + dobutamine + amrinone + milrinone (dose × 15) + epinephrine (dose × 100) + norepinephrine (dose × 100) + enoximone + isoprenaline (dose × 100), with each drug in µg/kg/min. Determinants of inotrope score were identified with linear regression. Cox regression was used to determine the association of inotrope score with mortality. Results: The mean recipient age was 52 ± 11 years, and 32 (39.5%) patients were female. Determinants of inotrope score were preoperative C‐reactive protein, serum urea, congenital heart disease, and donor cardiac arrest (R2 =.30). Inotrope score was associated with 5‐year mortality, independent of recipient age and gender (HR 1.03, 95% CI 1.00‐1.07). This association was attenuated when adjusting for female‐to‐male transplant and ischemia time. Inotrope score was also strongly associated with continuous veno‐venous hemofiltration (OR 1.07, 95% CI 1.03‐1.12). Conclusion: High inotrope score post‐HTx was observed in recipient congenital heart disease and was associated with a higher risk of mortality and acute kidney injury. [ABSTRACT FROM AUTHOR]

Project Goal:Create device to stabilize patient’s lung after suffering a tension pneumothorax Current treatments involve chest tubes that are prone to clotting and infection Can be used in non-sterile environment Can be used in transit and at the hospital Field and Hospital Versions of PAD Danny Baldo Jr., Horacio Estabridis, Vinson Tran, Kelsey Fung, Thanh Chung, Anthony PhamDepartment of Biomedical Engineering, University of California, IrvineFrancis Duhay: Edwards Lifesciences

Patients with refractory heart failure due to chronic progressive cardiac myopathy (CM) may require mechanical circulatory support as a bridge to transplantation. A few patients can be weaned from support devices if recovery can be achieved. The identification of these patients is of great importance as recovery may be missed if the heart is unloaded by the ventricular assist device (VAD). Testing the load-bearing capacity of the supported left ventricle (LV) by temporarily and gradually reducing mechanical support during cardiac exercise can help identify responders and potentially aid the recovery process. An exercise training protocol was used in 3 patients (8 months, 18 months and 8 years old) with histological CM findings and myocarditis. They were monitored regularly using clinical information and functional imaging with VAD support. Echocardiographic examination included both conventional real-time 3D echocardiography (RT3DE) and speckle tracking (ST). A daily temporary reduction in pump rate (phase A) was followed by a permanent reduction in rate (phase B). Finally, pump stops of up to 30 min were performed once a week (phase C). The final decision on explantation was based on at least three pump stops. Two patients were weaned and successfully removed from the VAD. One of them was diagnosed with acute viral myocarditis. The other had chronic myocarditis with dilated myopathy and mild interstitial fibrosis. The noninvasive assessment of cardiac output and strain under different loading conditions during VAD therapy is feasible and helps identify candidates for weaning despite severe histological findings. The presented protocol, which incorporates new echocardiographic techniques for determining volume and deformation, can be of great help in positively guiding the process of individual recovery, which may be essential for selecting and increasing the number of patients to be weaned from VAD.

Objectives: Cancer-therapy-related heart failure (CTrHF) due to cardiotoxic drugs or radiation is a growing cause of end-stage heart failure. Limited knowledge is available concerning the use of continuous-flow left-ventricular-assist devices (cfLVAD) in this setting. Methods: The files of all 1334 patients who underwent cfLVAD implantation between December 2008 and December 2020 were screened for the cause of heart failure. All patients with CTrHF were included in the analysis. Results: A total of 32 patients with a median age of 58 years (IQR: 46–65) were included in the study; 15 (47%) were male. The median time from the first diagnosis of heart failure (HF) to cfLVAD implantation was 6 months (IQR 2–24), and from cancer treatment to cfLVAD implantation 40 months (IQR 5–144). Malignancies comprised non-Hodgkin lymphoma (n = 12, 37%), breast cancer (n = 9, 28%), sarcoma (n = 5, 16%), leukemia (n = 5, 16%), and others (n = 1, 3%). In 24 patients, chemotherapy included anthracyclines (others n = 2, unknown n = 6). Chest radiation was performed in 13 patients (39%). Moreover, 71% were classified as INTERMACS profile 1 or 2. The 30-day survival rate after LVAD implantation was 88%. Rethoracotomy was necessary in nine (29%), and a temporary right ventricular assist device in seven (21%) patients. The median survival was 29 months. There was no significant difference in survival or right HF between patients with CTrHF and a matched control group. Conclusions: CfLVAD implantation is feasible in high-risk patients with CTrHF with or without prior chest radiation.

Background: Berlin Heart EXCOR (BH) ventricular assist devices provide mechanical long-term circulatory support in children with end-stage heart failure, as a bridge to transplantation or to recovery. Most studies are from large-volume paediatric cardiac centres.Aim: The aim of this study was to analyse the experiences of three French centres and to compare these with available published data.Method: We performed a retrospective observational study of three paediatric cardiac intensive care units. All children supported with BH devices were included. Morbidity and mortality data were collected and risk factors analysed.Results: Fifty-four (54) patients (54% male) were included. Survival rate was 73% while on a BH device. Median age at BH device implantation was 17 months (range 2-180 months). The predominant indication was dilated cardiomyopathy (61%). Bi-ventricular assist device was used in 25 (46%) cases. The total length of long-term circulatory support was 3,373 days, with a mean length per patient of 62.5 days (range 5-267 days). Thirty-two (32) patients were transplanted (59%) and seven (13%) were successfully weaned. Type and length of support did not influence morbidity. Main complications were renal dysfunction (57%), bleeding (41%), and infection (39%). In multivariate analysis, a weight <5 kg was significantly associated with higher mortality.Conclusions: The weight seems to be the most important risk factor of mortality in this precarious condition. [ABSTRACT FROM AUTHOR]

Aims: Acute right heart failure (RHF) is a severe complication of right ventricular infarction. The management of acute RHF poses a number of challenges, such as providing haemodynamic support. Temporary circulatory support (TCS) may be required upon failing medical therapy. The ProtekDuo® dual lumen cannula provides a minimally invasive option for (TCS) through a groin‐free internal jugular vein approach. We present the largest patient series to date using the ProtekDuo® cannula as temporary right ventricular assist device (t‐RVAD) in RHF after acute myocardial infarction (MI). Methods and results: From July 2016 to November 2019, 10 patients underwent t‐RVAD implantation for RHF following acute MI. Transthoracic and transoesophageal echocardiography were performed in all patients to assess cardiac function, with a particular focus on RV function. Cumulative 30‐day survival was 60%. Mean TAPSE was 6.4 ± 3.1 mm, mean fractional area change was 12.1 ± 4.2%, and mean right ventricular end diastolic area was 19.8 ± 2.7 cm2. Mean implantation time was 32.8 ± 8.3 min. Mean interval after first cardiac intervention was 4.6 ± 5.8 days. Mean t‐RVAD time was 10.0 ± 7.4 days with a significant reduction in central venous pressure 19.3 ± 2.7 vs. 8.2 ± 2.6 mmHg, P < 0.001 and a significant increase in central venous saturation 52.8 ± 15.6 vs. 80.0 ± 6.0%, P < 0.001. Mean intensive care unit stay was 18.6 ± 12.2 days. Four patients were weaned from TCS. Two patients were bridged to a long‐term paracorporeal RVAD. There were no t‐RVAD associated complications. Causes of death (n = 4) were multiorgan failure, electromechanical dissociation, and haemorrhagic stroke. Mean follow‐up time was 96.0 ± 107.6 days. No independent predictors of mortality were identified in univariate analysis. Conclusions: We show that groin‐free, percutaneous implantation of the ProtekDuo® cannula is a feasible and safe tool for TCS in acute RHF post‐MI. This approach provides the advantages of percutaneous implantation including complete mobilization and non‐surgical bedside explantation, as well as the option for adding an oxygenator to the t‐RVAD circuit. [ABSTRACT FROM AUTHOR]

A wearable power assist device was developed to reduce the stress on the lower back by using pneumatic muscles. The purpose of this study was to explore whether the assist device could reduce the activity or fatigue of lower back muscles during a repetitive lifting task. Twelve male subjects participated in the study. Electromyography of the thoracic erector spinae at the T9 level and lumbar erector spinae at the L3 level was recorded during 90 lifts in 15 min. Subjects' heart rate and Borg's Rate of Perceived Exertion Scale score were recorded during lifting sessions. The electromyography amplitude of thoracic erector spinae and lumbar erector spinae was only increased by 32.45% and 40.17%, respectively, when the wearable power assist device was used when comparing the pre- and post-lifting task. Whereas it was increased by 125.78% and 85.90%, respectively, when the wearable power assist device was not used. The decrease in electromyography median frequency from the start until the end of the lifting session was significantly lower when wearing the assist device for the thoracic erector spinae (2.72% vs 7.45%) and the lumbar erector spinae (3.91% vs 13.70%). Use of the assist device also significantly reduced the percentage change in heart rate and Borg Scale (p < 0.05). The use of the wearable power assist device showed less back muscle contraction compared to the no-use, which can potentially minimize the level of back muscle fatigue across the lifting session. • One of few existing studies on back support by using an active exoskeleton device. • Determined whether the device could reduce the back fatigue. • Electromyography signals at thoracic and lumbar erector spinae muscles were recorded. • Heart rates were shown before and after using the device. • The device can effectively reduce the muscle fatigue in a human body performing repetitive lifting tasks. [ABSTRACT FROM AUTHOR]

Heart transplantation has become a well-established treatment for end-stage heart failure, with dilated cardiomyopathies (DCM) forming the single largest group of patients to receive a cardiac transplant. This case study presents the surgical journey of a 63-year-old male who underwent a cardiac transplant for DCM. The pathophysiology of DCM is explained within the context of this patient's clinical presentation. His surgical transplant journey is also detailed, with a particular emphasis on his intensive care unit (ICU) stay and complications he experienced, including episodes of haemodynamic compromise and recurrent bleeding. The nursing management of his clinical recovery and patient education is also discussed. [ABSTRACT FROM AUTHOR]

Objective: Continuous-flow (CF) left ventricular assist devices (LVADs) have replaced pulsatile flow (PF) LVADs irrespective of concerns from the physiologic changes/morbidity secondary to lack of pulsatility. Data comparing posttransplant outcomes in patients with CF vs PF LVADs are limited and conflicting. We used the Organ Procurement and Transplant Network database to compare posttransplant outcomes between CF and PF LVAD patients.Methods: From 1 January 2005 to 31 December 2011, 3449 adult patients underwent primary heart alone transplantation. The cohort was restricted to 2741 recipients with LVAD at the time of transplant and divided into two groups: PF (Heartmate XVE) (n = 705) and CF (Heartmate II, HeartWare HVAD, and Jarvik 2000) (n = 2036). Endpoints were 30-day freedom from graft failure, 1-, and 5-year patient survival. Propensity score matching identified 705 pairs for adjusted comparisons.Results: Among propensity-matched patients, 30-day freedom from graft failure after heart transplantation (PF = 94.8% vs CF = 95.2%, P > .7), and 1-, and 5-year patient survival (PF; 87.5% vs CF; 88.9%, P = .4, and PF;75.7% vs CF;77.5%, P = .3) were not different.Conclusion: Survival and freedom from graft failure after heart transplantation is similar between CF and PF LVADs. These findings are relevant as the use of CF devices increases despite physiologic changes related to the absence of pulsatility. [ABSTRACT FROM AUTHOR]

Cardiogenic shock (CS) remains the most common cause of death in patients admitted with acute myocardial infarction (AMI) and mortality remained nearly unchanged in the range of 40–50% during the last two decades. Early revascularization, vasopressors and inotropes, fluids, mechanical circulatory support, and general intensive care measures are widely used for CS management. However, there is only limited evidence for any of the above treatment strategies except for revascularization and the relative ineffectiveness of intra-aortic balloon pumping. This updated review will outline the management of CS complicating AMI with major focus on state-of-the art treatment. Download slide Download slide [ABSTRACT FROM AUTHOR]

For assist in color discrimination of color vision defects, the method of observing objects through colored filter has been known. If red filter, which absorbs mostly all light except red light, is used, only the red objects can be highly visible. In this paper, a Heilmeier type guest‐host liquid crystal device with magenta dye was applied to a filter type assist device for red‐green color vision defect. This device can easily control transmittance of green light by changing applied voltage, and make green objects perceived to flicker synchronously. The subjective appraisal of the assist device in color discrimination was performed by five participants with normal vision using a constructed experimental system using a video camera and a PC with a vision simulator. For the confusion indices of the Panel D‐15 test, the effect of the device was statistically significant at P < .01. Moreover, a participant with color vision deficiency assessed it and got results without color confusion on the Panel D‐15 test. [ABSTRACT FROM AUTHOR]

BACKGROUND: The coronary vasculature encounters a reduction in pulsatility after implementing durable continuous-flow left ventricular assist device (CF-LVAD) circulatory support. Evidence exists that appropriate pulsatility is required to maintain endothelial cell homeostasis. We hypothesized that coronary artery endothelial function would be impaired after CF-LVAD intervention. METHODS AND RESULTS: Coronary arteries from patients with endstage heart failure caused by ischemic cardiomyopathy (ICM; n=16) or non-ICM (n=22) cardiomyopathy were isolated from the left ventricular apical core, which was removed for the CF-LVAD implantation. In 11 of these patients, paired coronary arteries were obtained from an adjacent region of myocardium after the CF-LVAD intervention (n=6 ICM, 5 non- ICM). Vascular function was assessed ex vivo using isometric tension procedures in these patients and in 7 nonfailing donor controls. Maximal endothelium-dependent vasorelaxation to BK (bradykinin; 10-6-10-10 M) was blunted (P<0.05) in arteries from patients with ICM compared with non-ICM and donor controls, whereas responses to sodium nitroprusside (10-4-10-9 M) were similar among the groups. Contrary to our hypothesis, vasorelaxation responses to BK and sodium nitroprusside were similar before and 219±37 days after CF-LVAD support. Of these patients, an exploratory subgroup analysis revealed that BK-induced coronary artery vasorelaxation was greater (P<0.05) after (87±6%) versus before (54±14%) CF-LVAD intervention in ICM patients, whereas sodium nitroprusside-evoked responses were similar. CONCLUSIONS: Coronary artery endothelial function is not impaired by durable CF-LVAD support and in ICM patients appears to be improved. Investigating coronary endothelial function using in vivo approaches in a larger patient population is warranted. [ABSTRACT FROM AUTHOR]

In the pulmonary circulation, resistive and compliant properties overlap in the same vessels. Resistance varies nonlinearly with pressure and flow; this relationship is driven by the elastic properties of the vessels. Linehan et al . (1982) correlated the mean pulmonary arterial pressure and mean flow with resistance using an original equation incorporating the distensibility of the pulmonary arteries. The goal of this study was to validate this equation in an in vivo porcine model. In vivo measurements were acquired in 6 pigs. The distensibility coefficient (DC) was measured by placing piezo-electric crystals around the pulmonary artery (PA). In addition to experiments under pulsatile conditions, a right ventricular (RV) bypass system was used to induce a continuous pulmonary flow state. The Linehan's equation was then used to predict the pressure from the flow under continuous flow conditions. The diameter-derived DC was 2.4 %/mmHg (±0.4 %), whereas the surface area-based DC was 4.1 %/mmHg (±0.1 %). An increase in continuous flow was associated with a constant decrease in resistance, which correlated with the diameter-based DC (r=-0.8407, p=0.044) and the surface areabased DC (r=-0.8986, p=0.028). In contrast to the Linehan's equation, our results showed constant or even decreasing pressure as flow increased. Using a model of continuous pulmonary flow induced by an RV assist system, pulmonary pressure could not be predicted based on the flow using the Linehan's equation. Measurements of distensibility based on the diameter of the PA were inversely correlated with the resistance. [ABSTRACT FROM AUTHOR]

Background: The role of intraaortic balloon counterpulsation (IABP) in cardiogenic shock is still a subject of intense debate despite the neutral results of the IABP-SHOCK II trial (Intraaortic Balloon Pump in Cardiogenic Shock II) with subsequent downgrading in international guidelines. So far, randomized data on the impact of IABP on long-term clinical outcomes in patients with cardiogenic shock complicating acute myocardial infarction are lacking. Furthermore, only limited evidence is available on general long-term outcomes of patients with cardiogenic shock treated by contemporary practice.Methods: The IABP-SHOCK II trial is a multicenter, randomized, open-label trial. Between 2009 and 2012, 600 patients with cardiogenic shock complicating acute myocardial infarction undergoing early revascularization were randomized to IABP versus control.Results: Long-term follow-up was performed 6.2 years (interquartile range 5.6-6.7) after initial randomization. Follow-up was completed for 591 of 600 patients (98.5%). Mortality was not different between the IABP and the control group (66.3% versus 67.0%; relative risk, 0.99; 95% CI, 0.88-1.11; P=0.98). There were also no differences in recurrent myocardial infarction, stroke, repeat revascularization, or rehospitalization for cardiac reasons (all P>0.05). Survivors' quality of life as assessed by the EuroQol 5D questionnaire and the New York Heart Association class did not differ between groups.Conclusions: IABP has no effect on all-cause mortality at 6-year long-term follow-up. Mortality is still very high, with two thirds of patients with cardiogenic shock dying despite contemporary treatment with revascularization therapy.Clinical Trial Registration: URL: https://www.Clinicaltrials: gov/. Unique identifier: NCT00491036. [ABSTRACT FROM AUTHOR]

Two‐dimensional echocardiography is a crucial component for assessing the position and function of mechanical circulatory support devices, but three‐dimensional echocardiography provides additional information to aid in management and may improve accuracy in the assessment of these devices. In this article, we review the utility of three‐dimensional echocardiography of various mechanical circulatory support devices. [ABSTRACT FROM AUTHOR]

Background: Implantable cardioverter-defibrillation (ICD) shocks after left ventricular assist device therapy (LVAD) are associated with adverse clinical outcomes. Little is known about the association of pre-LVAD ICD shocks on post-LVAD clinical outcomes and whether LVAD therapy affects the prevalence of ICD shocks., Objectives: The purpose of this study was to determine whether pre-LVAD ICD shocks are associated with adverse clinical outcomes post-LVAD and to compare the prevalence of ICD shocks before and after LVAD therapy., Methods: Patients 18 years or older with continuous-flow LVADs and ICDs were retrospectively identified within the University of Pittsburgh Medical Center system from 2006-2020. We analyzed the association between appropriate ICD shocks within 1 year pre-LVAD with a primary composite outcome of death, stroke, and pump thrombosis and secondary outcomes of post-LVAD ICD shocks and ICD shock hospitalizations., Results: Among 309 individuals, average age was 57 ± 12 years, 87% were male, 80% had ischemic cardiomyopathy, and 42% were bridge to transplantation. Seventy-one patients (23%) experienced pre-LVAD shocks, and 69 (22%) experienced post-LVAD shocks. The overall prevalence of shocks pre-LVAD and post-LVAD were not different. Pre-LVAD ICD shocks were not associated with the composite outcome. Pre-LVAD ICD shocks were found to predict post-LVAD shocks (hazard ratio [HR] 5.7; 95% confidence interval [CI] 3.42-9.48; P <.0001) and hospitalizations related to ICD shocks from ventricular arrhythmia (HR 10.34; 95% CI 4.1-25.7; P <.0001)., Conclusion: Pre-LVAD ICD shocks predicted post-LVAD ICD shocks and hospitalizations but were not associated with the composite outcome of death, pump thrombosis, or stroke at 1 year. The prevalence of appropriate ICD shocks was similar before and after LVAD implantation in the entire cohort., (© 2023 Heart Rhythm Society. Published by Elsevier Inc.)

Aims Evidence on the impact on clinical outcome of active mechanical circulatory support (MCS) devices in cardiogenic shock (CS) is scarce. This collaborative meta-analysis of randomized trials thus aims to investigate the efficacy and safety of percutanzeous active MCS vs. control in CS. Methods and results Randomized trials comparing percutaneous active MCS to control in patients with CS were identified through searches of medical literature databases. Risk ratios (RR) and 95% confidence intervals (95% CI) were calculated to analyse the primary endpoint of 30-day mortality and device-related complications including bleeding and leg ischaemia. Mean differences (MD) were calculated for mean arterial pressure (MAP), cardiac index (CI), pulmonary capillary wedge pressure (PCWP), and arterial lactate. Four trials randomizing 148 patients to either TandemHeartT℣ or ImpellaV® MCS (n = 77) vs. control (n = 71) were identified. In all four trials intra-aortic balloon pumping (IABP) served as control. There was no difference in 30-day mortality (RR 1.01, 95% CI 0.70 to 1.44, P = 0.98, I2 = 0%) for active MCS compared with control. Active MCS significantly increased MAP (MD 11.85 mmHg, 95% CI 3.39 to 20.31, P = 0.02, I2 = 32.7%) and decreased arterial lactate (MD - 1.36 mmol/L, 95% CI - 2.52 to - 0.19, I2 = 0%, P = 0.02) at comparable CI (MD 0.32, 95% CI - 0.24 to 0.87, P = 0.14, I2 = 44.1%) and PCWP (MD - 5.59, 95% -15.59 to 4.40, P = 0.14, I2 = 81.1%). No significant difference was observed in the incidence of leg ischaemia (RR 2.64, 95% CI 0.83 to 8.39, P = 0.10, I2 = 0%), whereas the rate of bleeding was significantly increased in MCS compared to IABP (RR 2.50, 95% CI 1.55 to 4.04, P < 0.001, I2 = 0%). Conclusion Results of this collaborative meta-analysis do not support the unselected use of active MCS in patients with CS complicating AMI. [ABSTRACT FROM AUTHOR]

Background In Japan, ventricular assist devices (VADs) have been used for patients with severe heart failure as a bridge to transplantation (BTT) since 1992. However, it was not until 1997, when the Organ Transplant Law was enacted, that medical devices received approval by the national health insurance system for that use. To encourage research and development of innovative medical devices, the Pharmaceuticals and Medical Devices Agency has established a public–private partnership in collaboration with academic societies, hospitals and manufacturers. Methods The Japanese registry for Mechanically Assisted Circulatory Support (J-MACS) is a prospective registry designed to be harmonized with the Interagency Registry of Mechanically Assisted Circulatory Support (INTERMACS). Participation in J-MACS is mandatory for device manufacturers to meet the conditions of approval as well as for hospitals to obtain authorization for reimbursement from the national health insurance system. Results From June 2010 to April 2015, 476 patients were registered at 31 hospitals. Of these, analysis of primary VAD patients ( n = 332) revealed that their overall 360-day survival was 91% (implantable 93%, extracorporeal 84%). Conclusions This initial report from J-MACS focuses on patients’ demographics, device types, survival, competing outcomes, adverse events and successful examples of system failure detection. [ABSTRACT FROM AUTHOR]

Objectives: Extracorporeal life support is used for patients with severe heart failure as a bridge to heart transplantation or recovery. We aimed at analyzing the efficacy and safety of extracorporeal life support to treat refractory arrhythmic storm responsible for cardiogenic shock in patients resistant to antiarrhythmic drugs.Design: Retrospective study.Setting: University Hospital of Rennes, France.Patients: Patients with refractory arrhythmic storm admitted between January 2005 and March 2015.Interventions: Patients with intractable refractory arrhythmic storm and cardiogenic shock despite optimal medical therapy were implanted with an extracorporeal life support. Patients' characteristics and outcomes after extracorporeal life support implantation were analyzed.Measurements and Main Results: Twenty-six patients (23 men, 52.4 ± 9.2 yr old) were included, most of them having ischemic cardiomyopathy (65.4%). Stable sinus rhythm restoration was immediate in 61.5% of patients and occurred after a median time of 3 hours after extracorporeal life support implantation for the remaining ones. Thirteen patients (50%) eventually died, none of them due to extracorporeal life support-related complications, but mostly due to the occurrence of multiple organ failure, and occurred after a median time of 4 days. The remaining 13 patients (50%) had extracorporeal life support withdrawn after 6.7 ± 3.6 days and were discharged after 34.7 ± 14.7 days after admission. Patients with repetitive ventricular tachycardia/ventricular fibrillation episodes alternating with periods of sinus rhythm at the time of implantation had a better survival than those in refractory ventricular fibrillation (p = 0.017).Conclusions: This is the largest database of patients temporary implanted with extracorporeal life support for refractory arrhythmic storm responsible for cardiogenic shock resistant to antiarrhythmic drugs. It provides efficient hemodynamic support and survival rate after the implantation is 50%. [ABSTRACT FROM AUTHOR]

Background: Although various hand assist devices have been commercialized for people with paralysis, they are somewhat limited in terms of tool fixation and device attachment method. Hand exoskeleton robots allow users to grasp a wider range of tools but are heavy, complicated, and bulky owing to the presence of numerous actuators and controllers. The GRIPIT hand assist device overcomes the limitations of both conventional devices and exoskeleton robots by providing improved tool fixation and device attachment in a lightweight and compact device. GRIPIT has been designed to assist tripod grasp for people with spinal cord injury because this grasp posture is frequently used in school and offices for such activities as writing and grasping small objects.Methods: The main development objective of GRIPIT is to assist users to grasp tools with their own hand using a lightweight, compact assistive device that is manually operated via a single wire. GRIPIT consists of only a glove, a wire, and a small structure that maintains tendon tension to permit a stable grasp. The tendon routing points are designed to apply force to the thumb, index finger, and middle finger to form a tripod grasp. A tension-maintenance structure sustains the grasp posture with appropriate tension. Following device development, four people with spinal cord injury were recruited to verify the writing performance of GRIPIT compared to the performance of a conventional penholder and handwriting. Writing was chosen as the assessment task because it requires a tripod grasp, which is one of the main performance objectives of GRIPIT.Results: New assessment, which includes six different writing tasks, was devised to measure writing ability from various viewpoints including both qualitative and quantitative methods, while most conventional assessments include only qualitative methods or simple time measuring assessments. Appearance, portability, difficulty of wearing, difficulty of grasping the subject, writing sensation, fatigability, and legibility were measured to assess qualitative performance while writing various words and sentences. Results showed that GRIPIT is relatively complicated to wear and use compared to a conventional assist device but has advantages for writing sensation, fatigability, and legibility because it affords sufficient grasp force during writing. Two quantitative performance factors were assessed, accuracy of writing and solidity of writing. To assess accuracy of writing, we asked subjects to draw various figures under given conditions. To assess solidity of writing, pen tip force and the angle variation of the pen were measured. Quantitative evaluation results showed that GRIPIT helps users to write accurately without pen shakes even high force is applied on the pen.Conclusions: Qualitative and quantitative results were better when subjects used GRIPIT than when they used the conventional penholder, mainly because GRIPIT allowed them to exert a higher grasp force. Grasp force is important because disabled people cannot control their fingers and thus need to move their entire arm to write, while non-disabled people only need to move their fingers to write. The tension-maintenance structure developed for GRIPIT provides appropriate grasp force and moment balance on the user's hand, but the other writing method only fixes the pen using friction force or requires the user's arm to generate a grasp force. [ABSTRACT FROM AUTHOR]

Patients with a continuous-flow left ventricular assist device may show recovery of myocardial function with unloading. Identifying candidates for and predicting clinical and hemodynamic stability after left ventricular assist device explantation remain challenging. Retrospective analysis of patients who underwent evaluation for left ventricular assist device explantation following a standardized protocol from January 2016 to March 2020. Patients who met screening criteria underwent echocardiography under "baseline," "minimal net flow," and "pump stop" conditions. If the protocol criteria were met, right heart catheterization with left ventricular assist device stoppage and occlusion of the outflow graft with a balloon catheter were performed. In patients with pulmonary capillary wedge pressure less than 16 mm Hg, explantation was performed under "pump stop" conditions. A total of 544 patients were screened. Of these, 57 (10.5%) underwent a total of 73 echocardiography under "baseline" "minimal net flow" and "pump stop" conditions and 46 underwent left ventricular assist device stoppage and occlusion of the outflow graft with balloon catheter maneuvers. Complications during the procedure were rare. Ultimately, 21 patients (3.9%) underwent explantation. The left ventricular ejection fraction at baseline was 55.5% ± 6.5%. The mean pulmonary capillary wedge pressure was 8.1 ± 2.6 mm Hg and increased to 10.7 ± 2.9 mm Hg under left ventricular assist device stoppage and occlusion of the outflow graft with a balloon catheter. A nonischemic cause of cardiomyopathy was more likely to be found in patients who underwent explantation (20/21 patients [95%], P =.020). The survival 1 year after explantation was 95.2%, with 1 death occurring 222 days after left ventricular assist device explantation. At follow-up (median 24.9 months [interquartile range, 16.4-43.1 months]), patients were in New York Heart Association class 1 (61.9%), 2 (28.6%), and 3 (9.5%). Our 4-year experience with a standardized protocol for left ventricular assist device explantation showed a low rate of adverse events. If all criteria are met, explantation can be performed safely and with an excellent survival and functional class. [Display omitted] [ABSTRACT FROM AUTHOR]

Scanning stages are used for precise positioning in a variety of advanced manufacturing processes, and must deliver high accelerations/decelerations at motion reversals to achieve high throughput. The resulting inertial forces cause excessive motor heating and residual vibration of the stage, both of which must be mitigated to preserve positioning accuracy. A novel scanning stage, having a permanent magnet based device that actively provides assist forces to the motor to simultaneously reduce motor heating and residual vibration, is presented. The active assist device is optimally designed to be versatile, allowing it to provide adequate assist for scan trajectories involving the widest range of scan strokes/positions. A basis–spline-based method is proposed for optimal control of the device, to maximize the assist it provides for scan trajectories with varying scan strokes/positions. Experiments conducted with a prototype stage involving scanning trajectories commonly employed in silicon wafer processing are used to demonstrate up to 60% and 34% reductions in heat and vibration-induced errors, respectively, when compared to cases without the proposed active assist device. [ABSTRACT FROM AUTHOR]

Aim Medical imaging by using FDG-PET/CT (PET-CT) can detect, confirm or eliminate with high sensitivity areas of suspected infections in case of persistent fever of unknown origin in combination with other bacteriological examinations. The aim of this study was to assess the potential role of PET-CT in detecting or excluding infections or other inflammatory processes in patients with congenital heart defects (CHD). In addition we wanted to evaluate the practical impact of PET-CT on the subsequent clinical management. Methods In this retrospective study we analyzed the data of all CHD patients who underwent PET-CT over a 5 year period in our institution. The results were then evaluated with regard to the potential impact on clinical decision making. Results Between 2010 and 2015 PET-CT was performed in 30 patients. The mean age was 26 years (SD 15 years, range 1 to 66 years). The diagnoses covered a large field of CHD. 11 patients (4/11 with assist device) were assessed before heart transplantation; suspected malignancies or infections were excluded and transplant listing was possible. In another 5/6 patients suspected assist device infection could be confirmed with PET/CT. Endocarditis was suspected in 13 patients, 2 of whom underwent previous MRI without confirmation and ECHO was inconclusive. Endocarditis was finally excluded in 5/13 patients but confirmed in 8/13 patients by PET-CT. Conclusion In this study we could show a high sensitivity of PET-CT for specific localization of infections and with high impact on subsequent therapy. Based on this results clinical management could be targeted and adapted. We could demonstrate that PET-CT has a high impact on the subsequent clinical therapy. [ABSTRACT FROM AUTHOR]

Cavopulmonary assist (CPA) for failing Fontan patients remains a challenging issue in the clinical setting. To evaluate the effectiveness of a partial CPA from the inferior vena cava (IVC) to the pulmonary artery (PA), we performed a theoretical analysis using a computational model of the Fontan circulation. Cardiac chambers and vascular systems were described as the time-varying elastance model and the modified three-element Windkessel model, respectively. A rotational pump described as a non-linear function was inserted between the IVC and the PA. When pulmonary vascular resistance index varied from 2.1 to 5.9 Wood units m, the partial CPA maintained cardiac index as efficiently as total CPA and markedly reduced the IVC pressure compared with total CPA. However, the partial CPA increased the superior vena cava pressure substantially. The modification from total to partial CPA is potentially an effective alternative in failing Fontan patients suffering from high IVC pressure. [ABSTRACT FROM AUTHOR]