Investigating the Impact of Guided Imagery on Stress, Brain Functions, and Attention: A Randomized Trial.

The aim of this study was to investigate the potential impact of guided imagery (GI) on attentional control and cognitive performance and to explore the relationship between guided imagery, stress reduction, alpha brainwave activity, and attentional control using common cognitive performance tests. Executive function was assessed through the use of attentional control tests, including the anti-saccade, Stroop, and Go/No-go tasks. Participants underwent a guided imagery session while their brainwave activity was measured, followed by attentional control tests. The study's outcomes provide fresh insights into the influence of guided imagery on brain wave activity, particularly in terms of attentional control. The findings suggest that guided imagery has the potential to enhance attentional control by augmenting the alpha power and reducing stress levels. Given the limited existing research on the specific impact of guided imagery on attention control, the study's findings carry notable significance.

The Middleware for an Exoskeleton Assisting Upper Limb Movement.

This article presents the possibilities of newly developed middleware dedicated for distributed and modular control systems. The software enables the exchange of information locally, within one control module, and globally, between many modules. The executed information exchange system speed tests confirmed the correct operation of the software. The middleware was used in the control system of the active upper-limb exoskeleton. The upper-limb rehabilitation exoskeleton structure with six degrees of mechanical freedom is presented. The tests were performed using the prototype with three joints. The drives' models of individual joints were developed and simulated. As a result, the courses of the motion trajectory were shown for different kinds of pressure on the force sensors, and different methods of signal filtering. The tests confirmed a correct operation of middleware and drives control system.

Impact of Intubation Time on Survival following Coronary Artery Bypass Grafting: Insights from the Surgical Treatment for Ischemic Heart Failure (STICH) Trial.

OBJECTIVE: The authors aimed to assess determinants of intubation time and evaluate its impact on 30-day and 1-year postoperative survival in Surgical Treatment for Ischemic Heart Failure (STICH) trial patients. DESIGN, SETTING, PARTICIPANTS, AND INTERVENTIONS: A multivariable Cox proportional hazards model was used among the 1,446 surgical patients from the STICH trial who survived 36 hours after operation, in order to identify perioperative factors associated with 30-day and 1-year postoperative mortality. A multivariable logistic regression model was used to determine risk factors associated with intubation time. MEASUREMENTS AND MAIN RESULTS: At 36 hours post-operation, 1,298 (out of 1,446) were extubated and 148 (10.2%) still intubated. Median postoperative intubation time was 11.4 hours. Among patients surviving 36 hours, a multivariable model was developed to predict 30-day (c-index = 0.88) and 1-year (c-index = 0.78) mortality. Intubation time was the strongest independent predictor of 30-day (hazard ratio [HR] 5.50) and 1-year mortality (HR 3.69). Predictors of intubation time >36 hours included mitral valve procedure, New York Heart Association class, left ventricular systolic volume index, creatinine, previous coronary artery bypass grafting (CABG), and age. Results were similar in patients surviving 24 hours post-operation, where intubation time was also the strongest predictor of 30-day (HR 4.18, c-index 0.87) and 1-year (HR 2.81, c-index 0.78) mortality. CONCLUSIONS: Intubation time is the strongest predictor of 30-day and 1-year mortality among patients with ischemic heart failure undergoing CABG. Combining intubation time with other mortality risk factors may allow the identification of patients at the highest risk for whom the development of specific strategies may improve outcomes.

Activities of Lysosomal Enzymes in Alloxan-Induced Diabetes in the Mouse.

The study investigated a panel of lysosomal enzymes in the liver and kidney tissues in alloxan-induced diabetes in the mouse. The mice were divided into six experimental groups receiving 10% alloxan at a dose of 50 and 75 mg/kg over a period of four, eight, and twelve days; each group was compared with controls receiving 0.9% NaCl. The findings were that diabetes induced by both doses of alloxan was accompanied by significant increases in the lysosomal activities of acid phosphatase and the glycosidases investigated: ß-glucuronidase, ß-galactosidase, ß-glucosidase, and N-acetyl-hexosaminidase. The lysosomal enzyme activity in both liver and kidney cells peaked 12 days after onset of diabetes for most enzymes, at the time when hyperglycemia and hyperinsulinemia already started abating after their peak at 8 days into the course of diabetes. The enzyme activity was in most cases higher with the higher dose of alloxan and thus higher level of glycemia. Lysosomal enzymes degrade glycoconjugates, the molecules that are present in the basement membrane of endothelial cells where they contribute to capillary wall stability. Thus, enhanced activity of these enzymes could presage the progression of diabetic microangiopathy, atherosclerosis, and the development of microvascular complications.

Influence of Baseline Characteristics, Operative Conduct, and Postoperative Course on 30-Day Outcomes of Coronary Artery Bypass Grafting Among Patients With Left Ventricular Dysfunction: Results From the Surgical Treatment for Ischemic Heart Failure (STICH) Trial.

BACKGROUND: Patients with severe left ventricular dysfunction, ischemic heart failure, and coronary artery disease suitable for coronary artery bypass grafting (CABG) are at higher risk for surgical morbidity and mortality. Paradoxically, those patients with the most severe coronary artery disease and ventricular dysfunction who derive the greatest clinical benefit from CABG are also at the greatest operative risk, which makes decision making regarding whether to proceed to surgery difficult in such patients. To better inform such decision making, we analyzed the Surgical Treatment for Ischemic Heart Failure (STICH) CABG population for detailed information on perioperative risk and outcomes. METHODS AND RESULTS: In both STICH trials (hypotheses), 2136 patients with a left ventricular ejection fraction of ≤35% and coronary artery disease were allocated to medical therapy, CABG plus medical therapy, or CABG with surgical ventricular reconstruction. Relationships of baseline characteristics and operative conduct with morbidity and mortality at 30 days were evaluated. There were a total of 1460 patients randomized to and receiving surgery, and 346 (≈25%) of these high-risk patients developed a severe complication within 30 days. Worsening renal insufficiency, cardiac arrest with cardiopulmonary resuscitation, and ventricular arrhythmias were the most frequent complications and those most commonly associated with death. Mortality at 30 days was 5.1% and was generally preceded by a serious complication (65 of 74 deaths). Left ventricular size, renal dysfunction, advanced age, and atrial fibrillation/flutter were significant preoperative predictors of mortality within 30 days. Cardiopulmonary bypass time was the only independent surgical variable predictive of 30-day mortality. CONCLUSIONS: CABG can be performed with relatively low 30-day mortality in patients with left ventricular dysfunction. Serious postoperative complications occurred in nearly 1 in 4 patients and were associated with mortality. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00023595.

Myocardial viability and survival in ischemic left ventricular dysfunction.

BACKGROUND: The assessment of myocardial viability has been used to identify patients with coronary artery disease and left ventricular dysfunction in whom coronary-artery bypass grafting (CABG) will provide a survival benefit. However, the efficacy of this approach is uncertain. METHODS: In a substudy of patients with coronary artery disease and left ventricular dysfunction who were enrolled in a randomized trial of medical therapy with or without CABG, we used single-photon-emission computed tomography (SPECT), dobutamine echocardiography, or both to assess myocardial viability on the basis of prespecified thresholds. RESULTS: Among the 1212 patients enrolled in the randomized trial, 601 underwent assessment of myocardial viability. Of these patients, we randomly assigned 298 to receive medical therapy plus CABG and 303 to receive medical therapy alone. A total of 178 of 487 patients with viable myocardium (37%) and 58 of 114 patients without viable myocardium (51%) died (hazard ratio for death among patients with viable myocardium, 0.64; 95% confidence interval [CI], 0.48 to 0.86; P=0.003). However, after adjustment for other baseline variables, this association with mortality was not significant (P=0.21). There was no significant interaction between viability status and treatment assignment with respect to mortality (P=0.53). CONCLUSIONS: The presence of viable myocardium was associated with a greater likelihood of survival in patients with coronary artery disease and left ventricular dysfunction, but this relationship was not significant after adjustment for other baseline variables. The assessment of myocardial viability did not identify patients with a differential survival benefit from CABG, as compared with medical therapy alone. (Funded by the National Heart, Lung, and Blood Institute; STICH ClinicalTrials.gov number, NCT00023595.).

Transcatheter transseptal treatment of patients with severe mitral regurgitation using an atrial fixation mitral valve replacement technology.

BACKGROUND: Mitral regurgitation (MR) is the most common valvular heart disease worldwide with a 5-year mortality rate of 50 % with medical therapy alone. Several transcatheter mitral valve replacement (TMVR) devices are being investigated in clinical trials. Early evidence has demonstrated clinical benefits with a reduction in heart failure symptoms, low rates of residual MR, and reverse remodeling of the left ventricle (LV) over time. However, high anatomical screen failure rates limit its applicability. The primary reasons for the anatomical screen failure are risk of LV outflow tract obstruction, large mitral valve annulus size, and the presence of mitral annular calcification. Our clinical experiences using an atrial only fixation TMVR technology delivered via a transfemoral-transseptal approach is described. METHODS: Three consecutive patients with severe functional MR underwent TMVR implantation using an atrial only fixation technology and a low-profile transseptal delivery system. RESULTS: Technical success was achieved in 100 % of the patients with a clinically significant reduction in MR. Longer-term follow-up (up to 6-months) has demonstrated a sustained reduction in MR and significant improvement in quality of life for all patients. CONCLUSIONS: Longer-term outcomes in our patients showed persistent reduction in MR, sustained implant performance, and notable improvements in NYHA Class and quality of life. There were no major adverse events. Follow-up CT data showed no evidence of device-related thrombosis, with stable valve position and integrity. The atrial fixation TMVR technology may have benefits in preserving the dynamics of the native mitral valve annulus thereby reducing the overall risk of LVOT obstruction. SHORT ABSTRACT: We present a single-center experience of three consecutive patients with severe functional MR treated with the AltaValve using a low-profile transseptal delivery system. A clinically significant reduction in mitral regurgitation was achieved in all patients, and longer-term follow-up has demonstrated sustained clinical benefits.

AltaValve Atrial Fixation System for the Treatment of Severe Mitral Regurgitation and Mitral Annular Calcification.

Background: Treatment options for patients with mitral regurgitation (MR) and mitral annular calcification (MAC) are limited. The limitations of current transcatheter mitral valve replacement (TMVR) technologies include high screen failure rates, increased risk of left ventricular outflow tract obstruction, and high residual regurgitation. The aim of this study was to evaluate outcomes of TMVR with the AltaValve system (4C Medical, Maple Grove, MN), a supra-annular TMVR with atrial fixation, in patients with severe MR and moderate or severe MAC. Methods: Six patients with moderate or severe MAC who were treated with AltaValve TMVR had procedural and mid-term outcomes available. Results: Technical success was achieved in all patients. Median follow-up was 232 days. At discharge, 80% of patients had none/trace MR, and 20% had mild MR. There was no intraprocedural mortality, device malposition, embolization, or thrombosis. One patient expired 3 days postprocedure due to complications related to the transapical access. All other patients were discharged from the hospital without issues. Echocardiography assessments at 30 days showed complete resolution of MR in all patients, with 1 patient with mild MR and a mean mitral valve gradient of 3.7 ± 1.4 mmHg. All patients were in New York Heart Association Class I/II at 30-day follow-up, showing marked improvement as compared with baseline. Conclusions: In patients with severe MR and severe MAC, the AltaValve TMVR technology may represent a viable treatment option. The atrial fixation minimizes the risk of left ventricular outflow tract obstruction and potentially expands treatable patients, especially in patients with MAC.

The Right Coronary Anatomy and Operative Topography of the Tricuspid Valve Annulus.

BACKGROUND: The region of the tricuspid valve is an important area for various cardiac interventions. In particular, the spatial relationships between the right coronary artery and the annulus of the tricuspid valve should be considered during surgical interventions. The aim of this study was to provide an accurate description of the clinical anatomy and topography of this region. METHODS: We analyzed 107 computed tomography scans (44% female, age 62.1 ± 9.4 years) of the tricuspid valve region. The circumference of the free wall of the tricuspid valve annulus was divided into 13 annular points and measurements were taken at each point. The prevalence of danger zones (distance between artery and annulus less than 2 mm) was also investigated. RESULTS: Danger zones were found in 20.56% of the cases studied. The highest prevalence of danger zones and the smallest distances were found at the annular points of the tricuspid valve located at the posterior insertion of the leaflets, without observed sex-specific differences. CONCLUSION: The highest risk of iatrogenic damage to the right coronary artery is in the posterior part of the tricuspid valve annulus.

Chronic thromboembolic disease among patients undergoing surgical pulmonary embolectomy for acute pulmonary embolism.

BACKGROUND: This study aimed to assess the prevalence of chronic thromboembolic lesions in the pulmonary arteries among patients undergoing pulmonary embolectomy for acute pulmonary embolism and their impact on treatment outcomes. METHODS: We conducted a retrospective, single-center analysis of consecutive patients undergoing emergency pulmonary embolectomy for acute pulmonary embolism between 2013 and August 2021. According to European Society of Cardiology guidelines, the diagnosis was based on clinical presentation, imaging studies and laboratory tests. Surgery was selected as the optimal treatment modality within the Pulmonary Embolism Response Team. Based on the intraoperatively identified chronic lesions patients were divided into two groups: acute only and acute/chronic. The analysis comprised history, laboratory and imaging studies, early and long-term mortality, and postoperative complications. We determined predictive factors for chronic thromboembolic lesions and risk factors for death. RESULTS: The analysis included 33 patients. Intraoperatively, 42% (14) of patients had chronic lesions. Predictive factors for these lesions are the duration of symptoms >1 week (OR=13.75), pulmonary artery dilatation >3.15 cm (OR=39.00) and right ventricle systolic pressure >52 mmHg (OR=29.33). No hospital deaths occurred in the acute only group and two in the acute/chronic group (0% vs. 14.3%; P=0.172). Risk factors for death are the duration of symptoms >3 weeks (HR=7.35) and postoperative use of extracorporeal membrane oxygenation (HR=7.04). CONCLUSIONS: Acute thromboembolic disease overlapping chronic clots is relatively common among patients undergoing pulmonary artery embolectomy. A detailed evaluation of the patient's medical history and imaging studies can identify these patients, as they require special attention when making treatment decisions. Surgical treatment in a center of expertise in pulmonary endarterectomy seems reasonable.

Influence of mitral regurgitation repair on survival in the surgical treatment for ischemic heart failure trial.

BACKGROUND: Whether mitral valve repair during coronary artery bypass grafting (CABG) improves survival in patients with ischemic mitral regurgitation (MR) remains unknown. METHODS AND RESULTS: Patients with ejection fraction ≤35% and coronary artery disease amenable to CABG were randomized at 99 sites worldwide to medical therapy with or without CABG. The decision to treat the mitral valve during CABG was left to the surgeon. The primary end point was mortality. Of 1212 randomized patients, 435 (36%) had none/trace MR, 554 (46%) had mild MR, 181 (15%) had moderate MR, and 39 (3%) had severe MR. In the medical arm, 70 deaths (32%) occurred in patients with none/trace MR, 114 (44%) in those with mild MR, and 58 (50%) in those with moderate to severe MR. In patients with moderate to severe MR, there were 29 deaths (53%) among 55 patients randomized to CABG who did not receive mitral surgery (hazard ratio versus medical therapy, 1.20; 95% confidence interval, 0.77-1.87) and 21 deaths (43%) among 49 patients who received mitral surgery (hazard ratio versus medical therapy, 0.62; 95% confidence interval, 0.35-1.08). After adjustment for baseline prognostic variables, the hazard ratio for CABG with mitral surgery versus CABG alone was 0.41 (95% confidence interval, 0.22-0.77; P=0.006). CONCLUSION: Although these observational data suggest that adding mitral valve repair to CABG in patients with left ventricular dysfunction and moderate to severe MR may improve survival compared with CABG alone or medical therapy alone, a prospective randomized trial is necessary to confirm the validity of these observations. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00023595.

Surgical pulmonary embolectomy: state of the art.

Acute pulmonary embolism is a significant cause of morbidity and mortality. Patients in life-threatening conditions require timely and effective interventions to improve pulmonary perfusion. The indications for surgical embolectomy in the thrombolysis era have been limited. This article discusses surgical techniques and outlines the position of surgical embolectomy concerning other treatment modalities.

Investigating brain cortical activity in patients with post-COVID-19 brain fog.

Brain fog is a kind of mental problem, similar to chronic fatigue syndrome, and appears about 3 months after the infection with COVID-19 and lasts up to 9 months. The maximum magnitude of the third wave of COVID-19 in Poland was in April 2021. The research referred here aimed at carrying out the investigation comprising the electrophysiological analysis of the patients who suffered from COVID-19 and had symptoms of brain fog (sub-cohort A), suffered from COVID-19 and did not have symptoms of brain fog (sub-cohort B), and the control group that had no COVID-19 and no symptoms (sub-cohort C). The aim of this article was to examine whether there are differences in the brain cortical activity of these three sub-cohorts and, if possible differentiate and classify them using the machine-learning tools. he dense array electroencephalographic amplifier with 256 electrodes was used for recordings. The event-related potentials were chosen as we expected to find the differences in the patients' responses to three different mental tasks arranged in the experiments commonly known in experimental psychology: face recognition, digit span, and task switching. These potentials were plotted for all three patients' sub-cohorts and all three experiments. The cross-correlation method was used to find differences, and, in fact, such differences manifested themselves in the shape of event-related potentials on the cognitive electrodes. The discussion of such differences will be presented; however, an explanation of such differences would require the recruitment of a much larger cohort. In the classification problem, the avalanche analysis for feature extractions from the resting state signal and linear discriminant analysis for classification were used. The differences between sub-cohorts in such signals were expected to be found. Machine-learning tools were used, as finding the differences with eyes seemed impossible. Indeed, the A&B vs. C, B&C vs. A, A vs. B, A vs. C, and B vs. C classification tasks were performed, and the efficiency of around 60-70% was achieved. In future, probably there will be pandemics again due to the imbalance in the natural environment, resulting in the decreasing number of species, temperature increase, and climate change-generated migrations. The research can help to predict brain fog after the COVID-19 recovery and prepare the patients for better convalescence. Shortening the time of brain fog recovery will be beneficial not only for the patients but also for social conditions.

Changing Face of Inflammatory Activation in Complex Coronary Artery Disease during the COVID-19 Pandemic.

INTRODUCTION: The COVID-19 pandemic has changed the immunological status of the population, indicating increased activation. The aim of the study was to compare the degree of inflammatory activation in patients admitted for surgical revascularization in the period before and during the COVID-19 pandemic. MATERIALS AND METHODS: This retrospective analysis included an analysis of inflammatory activation assessed on the basis of whole blood counts in 533 patients (435 (82%) male and 98 (18%) female) with a median age of 66 (61-71) years who underwent surgical revascularization, including 343 and 190 patients operated on in 2018 and 2022, respectively. RESULTS: The compared groups were matched by propensity score matching analysis, obtaining 190 patients in each group. Significantly higher values of preoperative monocyte count (p = 0.015), monocyte-to-lymphocyte ratio (p = 0.004) and systemic inflammatory response index (p = 0.022) were found in the during-COVID subgroup. The perioperative and 12-month mortality rates were comparable, with 1% (n = 4) in 2018 vs. 1% (n = 2) in 2022 (p = 0.911), and 5.6 % (n = 11 patients) vs. 7% (n = 13 patients) (p = 0.413), in the pre-COVID and during-COVID subgroups, respectively. CONCLUSIONS: Simple whole blood analysis in patients with complex coronary artery disease performed before and during the COVID-19 pandemic indicates excessive inflammatory activation. However, the immune variation did not interfere with one-year mortality rate after surgical revascularization.

The Utility of a Resting Electrocardiogram (ECG-PH Index) in Evaluating the Efficacy of Pulmonary Endarterectomy in Chronic Thromboembolic Pulmonary Hypertension.

BACKGROUND: The ECG-PH index (PH-ECG score) has been proposed as a valuable ECG-derived method of evaluating the effectiveness of balloon pulmonary angioplasty (BPA) in chronic thromboembolic pulmonary hypertension (CTEPH). Pulmonary endarterectomy (PEA) is the main form of therapy for CTEPH with a proximal clot location. The objective of this study was to assess the clinical utility of a resting electrocardiogram (ECG-PH index) in assessing the effectiveness of PEA in CTEPH patients. METHODS: The retrospective analysis included 73 patients who underwent PEA. Their ECG-PH index values were calculated using four ECG parameters: R-wave amplitude V1 + S-wave amplitude V5/V6 > 10.5 mm, QRS-wave axis > 110 degrees, R-wave amplitude V1 > S-wave amplitude V1, and SIQIII pattern. PH-ECG scores were assessed after a median time of 13 months (IQR: 8-31 months) had passed since the PEA procedures. RESULTS: The current analysis documented that ECG-PH index = 0 is a good reflection of mPAP < 25mmHg (sensitivity 76.1%; specificity 66.7%; positive predictive value 79.5%; negative predictive value 62.1%) or mPAP ≤ 20 mmHg (sensitivity 69.6%; specificity 70.6%; positive predictive value 88.6%; negative predictive value 41.4%) after PEA. The values of the area under the ROC curve for ECG-PH index were 0.772 (95% CI: 0.676-0.867) and 0.743 (95% CI: 0.637-0.849) for the mPAP < 25 mmHg and mPAP ≤ 20 mmHg patient groups, respectively. CONCLUSION: The ECG-PH index may be useful for monitoring the haemodynamic effect of PEA in CTEPH patients.

Acute pulmonary embolism with coexisting right heart thrombi in transit-surgical treatment of 20 consecutive patients.

OBJECTIVES: The presence of right heart thrombi in transit (RHTiT) in the setting of acute pulmonary embolism (PE) is associated with high mortality. The optimal management in such cases is inconclusive. We present the results of surgical treatment of 20 consecutive patients diagnosed with high- or intermediate-high-risk PE with coexisting RHTiT. METHODS: A retrospective analysis was performed of all consecutive patients undergoing surgical treatment in the Medicover Hospital between 2013 and 2021 for acute PE with coexisting thrombi in-transit in right heart cavities. The diagnosis was based on echocardiography, computed tomography pulmonary angiography and laboratory tests. Eligibility criteria for surgical treatment were acute PE with RHTiT, right ventricular overload on imaging studies and significantly elevated levels of cardiac troponin and NTproBNP. All patients were operated on with extracorporeal circulation using deep hypothermia and total circulatory arrest. The primary end point was hospital all-cause mortality; secondary end points were perioperative complications and long-term mortality. RESULTS: The analysis included 20 patients. There was no in-hospital death. Nearly one-third of patients required temporal hemofiltration for postoperative renal failure, but this did not involve the need for dialysis at discharge. No neurological complications occurred in any patient. The mean follow-up was 46 months (range 13-98). There was 1 death in the long-term follow-up, not related to PE. CONCLUSIONS: Surgical treatment of patients with acute PE and coexisting RHTiT can provide favourable results.

Mechanical Circulatory Support in Delayed Surgery of Post-Infarction Ventricular Septal Rupture in Patients in Cardiogenic Shock-A Review.

Post-infarction ventricular septal rupture (VSR) is a serious complication of myocardial infarction, which, in its natural course or treated medically, is related to high mortality rate. Surgical intervention remains the treatment of choice. Recent studies have shown that delayed surgery is related to better outcomes in comparison with urgent surgery; however, in many studies the impact of the patients' initial hemodynamic status on the treatment outcomes often remains unclear. In this review, we analyze the outcomes of delayed surgical treatment of patients in cardiogenic shock in the course of post-infarction ventricular septal defect stabilized with preoperative use of mechanical circulatory support. We evaluate the importance of various types of mechanical circulatory devices (MCD), such as extracorporeal membrane oxygenation, Tandem Heart, Impella, and intra-aortic baloon pump (IABP) in preoperative stabilization of patients, and the most suitable time for surgery, and we also present the features of ideal MCD for patients with VSR. A search of Pubmed to identify studies concerning the use of MCD in patients in cardiogenic shock in the course of VSR qualified for delayed surgery was conducted in January 2022. A total of 16 articles with three or more patients described were analyzed in this study. The preoperative use of MCD in patients in cardiogenic shock and delayed surgery as a main part of treatment seems to be a promising direction, however, it requires further research.

Safety and Efficacy of a Novel Blunt-Tip Concealed-Needle Epicardial Access Device: First-in-Human Feasibility Study.

Epicardial access is becoming increasingly important for various cardiovascular interventions. Access to dry pericardial space can be challenging and is often associated with significant complications. A novel concealed-needle blunt-tip device is designed to capture the parietal pericardium layer and retract it into the distal end of the device, which houses a fixated concealed needle, in a bid to minimize the likelihood of lacerating the visceral layer of the pericardium. This prospective single-arm study evaluated the feasibility of use of this device in 11 human subjects with successful access attained in 91% (10 of 11) of cases without adverse events. (Pericardial Access With ViaOne Device; NCT05006157).