OBJECTIVE: The resiliency of patients who have advanced heart failure (HF) and undergo a physical stressor such as heart transplantation or left ventricular assist device implantation has yet to be studied in the physical, cognitive, and psychosocial domains. The primary aim of this pilot study was to assess the feasibility of a multidomain resiliency assessment in patients who have advanced HF and require surgery.
METHODS: A battery of assessments in each of the domains was completed at baseline before surgical intervention, after intensive care discharge, and 3 and 6 months after surgery. Feasibility was assessed through completion rates, time required to complete the assessments, and qualitative feedback from assessors.
RESULTS: Although various completion rates were noted at different time points, high completion rates were seen for grip strength, the modified Fried frailty phenotype, and the Montreal Cognitive Assessment. Additionally, when controlled for patients who were medically restricted from physical function, the Short Physical Performance Battery, gait speed, and the 30-second chair stand test also had high completion rates. A trend toward return to baseline status or an improvement in baseline status was observed in all physical and cognitive assessments and most psychosocial assessments at 3 and 6 months. Minimal change was noted in the Brief Resilience Scale questionnaire.
CONCLUSIONS: This pilot study demonstrates that a multidomain assessment of resiliency is feasible in patients with advanced HF. Future studies are needed to help determine specific assessments or patient factors that would help predict positive postsurgical outcomes in this population.
CONCLUSIONS: This study has implications for clinical practice on the most feasible assessments in multiple domains for patients who have advanced HF and are being evaluated for heart transplantation or left ventricular assist device.

BACKGROUND: There is an increasing prevalence of durable mechanical circulatory supported patients in both the in-and-out of hospital communities. The scientific literature regarding the approach to patients supported by durable mechanical circulatory devices who suffer acutely impaired perfusion has not been well explored.
METHODS: The International Liaison Committee on Resuscitation Advanced, Basic, and Pediatric Life Support Task Forces conducted a scoping review of the literature using a population, context, and concept framework.
RESULTS: A total of 32 publications that included patients who were receiving durable mechanical circulatory support and required acute resuscitation were identified. Most of the identified studies were case reports or small case series. Of these, 11 (34.4%) included patients who received chest compressions. A number of studies reported upon delays in the application of chest compressions resulting from complexity due to the expected pulselessness in some patients with continuous flow left-ventricular assist devices as well as from concern regarding potential dislodgement of the mechanical circulatory support device. Three observational studies identified worse outcomes in durable mechanical circulatory support receiving patients with cardiac arrest and acutely impaired perfusion who received chest compressions as compared to those who did not, however those studies were at high risk of bias. Of 226 patients across 11 studies and two published scientific abstracts who sustained cardiac arrest while supported by durable MCS and underwent chest compressions, there were no reported instances of device dislodgement and 71 (31.4%) patients had favorable outcomes.
CONCLUSIONS: There is a scarcity of evidence to inform the resuscitation of patients with durable mechanical circulatory support (MCS) experiencing acute impairment in perfusion and cardiac arrest. Reports indicate that delays in resuscitation often stem from rescuers\' uncertainty about the safety of administering chest compressions. Notably, no instances of device dislodgement have been documented following chest compressions, suggesting that the risk of harm from timely CPR in these patients is minimal.

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OBJECTIVE: Left Ventricular Assist Device (LVAD) therapy has evolved from a short-term bridge-to-transplant strategy into a long-term and often chronic therapy due to long waiting times for heart transplantation and application as destination therapy. Consequently, patients are at risk of developing complications necessitating LVAD exchange. The aim of this study is to assess patient outcome after LVAD exchange.
METHODS: Patients who underwent LVAD exchange between January 2010 and December 2022 were included. Logistic and cox regression analyses were used to identify potential risk factors for short and long-term adverse events, respectively. Survival after exchange was assessed using Kaplan-Meier estimates.
RESULTS: Sixty-one patients underwent a total of 80 LVAD exchanges. Most frequently observed short-term complications were pulmonary infections (16.3%) and right heart failure (16.3%). Exit-site infections (34.7%) and device malfunctions (25.3%) were the most often observed long-term complications. HeartWare Ventricular Assist Device (HVAD) as index device was associated with a higher risk of right heart failure (HR 6.42, 95% CI 1.80-22.90) and respiratory failure (HR 7.81, 95% CI 1.95-31.23) compared to HeartMate II and HeartMate 3. Survival was 83% (95% CI 75.5%-95.3%) at one year and 67% (95% CI 53.9%-84.7%) at six years after exchange. After five years, 25.0% was transplanted, 23.8% had undergone a re-exchange and 32.5% was alive without new intervention.
CONCLUSIONS: Although LVAD exchange can be performed with a relatively low mortality, other post-operative adverse events are common. Patients with the HVAD as index device may be at higher risk of developing right heart failure and respiratory failure after exchange.

BACKGROUND: The impact of continuous flow resulting from contemporary left ventricular assist devices (LVAD) on renal vascular physiology is unknown. Renal resistive index (RRI) reflects arterial compliance, as well as renal vascular resistance, contributed by afferent and efferent arteriolar tone, the renal interstitium as well as renal venous pressures.
METHODS: Prospective, single center study with renal Doppler evaluation at baseline (pre-implant) and at 3-months support. Outcomes assessed include need for post-operative renal replacement therapy (RRT), worsening renal function (WRF) defined as persistent increase from pre-implant KDIGO chronic kidney disease stage, right ventricular (RV) failure, and survival to transplantation.
RESULTS: Pre-implant RRI did not predict cardiorenal outcomes including right heart failure, need for renal replacement therapy or worsening renal function. Post-implant RRI was significantly lower than pre-implant RRI, with a distinct Doppler waveform characteristic of continuous flow. Post-implant renal end-diastolic velocity, but not RRI, correlated strongly with LVAD flow (Spearman rho -0.99, p < 0.001), with trend toward correlation with mean arterial pressure (Spearman\'s rho 0.63, p = 0.129). There was a negative correlation between post-implant RRI and mean pulmonary artery pressure (Spearman\'s rho -0.81, p = 0.049), likely driven by elevated pulmonary capillary wedge pressure (Spearman\'s rho -0.83, p = 0.058).
CONCLUSIONS: The hemodynamic contributors to RRI in LVAD supported patients are complex. Higher mean pulmonary artery and pulmonary capillary wedge pressures seen in lower RRI may reflect a smaller difference in systolic and diastolic flow. Future simultaneous Doppler assessment of the LVAD outflow graft and RRI may help understand the hemodynamic interactions contributing to this index.

OBJECTIVE: To address the clinical need for totally implantable mechanical circulatory support devices, Bionet Sonar is developing a novel Ultrasonic Transcutaneous Energy Transmission (UTET) system that is designed to eliminate external power and/or data communication drivelines.
METHODS: UTET systems were designed, fabricated, and pre-clinically tested using a non-clinical HeartWare HVAD in static and dynamic mock flow loop and acute animal models over a range of pump speeds (1800, 2400, 3000 RPM) and tissue analogue thicknesses (5, 10, 15 mm).
RESULTS: The prototypes demonstrated feasibility as evidenced by meeting/exceeding function, operation, and performance metrics with no system failures, including achieving receiver (harvested) power exceeding HVAD power requirements and data communication rates of 10kB/s and pump speed control (> 95% sensitivity and specificity) for all experimental test conditions, and within healthy tissue temperature range with no acute tissue damage.
CONCLUSIONS: During early-stage development and testing, engineering challenges for UTET size reduction and stable and safe operation were identified, with solutions and plans to address the limitations in future design iterations also presented.

Patients on left ventricular assist devices (LVAD) are prone to excessive hemostasis disturbances due to permanent contact of artificial pump surfaces with blood components. We aimed to investigate if fibrin clot permeability is altered in patients on long-term continuous-flow LVAD therapy and if the clot permeability is associated with clinical characteristics and adverse events. We investigated 85 end-stage heart failure patients (90.6% men, age 48.6-63.8 years) scheduled for continuous flow long-term LVAD support according to current clinical indications. The patients were assessed periodically: prior to LVAD implantation (T1), 3-6 months (T2) after LVAD implantation, 6-12 months after (T3) and then every 6 months. We tested the first three blood samples (T1-T3) and the last available blood sample (T4), but no longer than 5 years after LVAD implantation. We assessed hemostasis parameters (Activated Partial Thromboplastin Time (APTT) Prothrombin Time, Activated Partial Thromboplastin Time, Fibrinogen, D-dimer, Antithrombin, Thrombin Time, Factor VIII, and von Willebrand Factor, aspirin-induced platelet inhibition, adenosine-diphosphate test) changes during the study period. Fibrin Clot Permeability was evaluated using a pressure system and Permeability Coefficient (Ks) was calculated. We observed a decrease in fibrin clot permeability (Ks) between T1, T2, T3 and T4 time periods; P < 0.01 for each comparison. Fibrin clot permeability was negatively correlated with fibrinogen concentration: r = - 0.51, P < 0.001, factor VIII activity r = - 0.42, P < 0.001. There was no association of Ks with age, Left Ventricular Ejection Fraction (LVEF) and medications P > 0.001, however cumulative measurements in patients on aspirin showed shortening of Ks in this group P = 0.0123. Major adverse cardiac and cerebrovascular events (MACCE) occurred in 36.5% patients, bleeding events in 25.9%, Net Adverse Clinical Events (NACE) in 62.4%; 31.7% patients died, and 17.6% underwent transplantation. The transplantation was considered as the endpoint. Discrepancies in Ks were observed between patients with MACCE, bleeding, and NACE, and patients without adverse events. Ks showed a constant trend towards normalization (P < 0.01) only in patients without adverse events. Patients with advanced heart failure have disturbed clot structure. A trend towards normalization of the Ks values is associated with fewer thromboembolic and bleeding complications in this group of patients.

OBJECTIVE: This EUROMACS study was conducted with the primary aim of investigating the association between a centre\'s annual caseload and postoperative outcomes among patients undergoing left ventricular assist device (LVAD) implantation.
RESULTS: A total of 4802 patients identified between 2011 and 2020 from 35 participating centres were dichotomized based on the annual caseload of the treating centre at the time of device implant (≤30 vs. >30 LVAD implantations/year). The primary endpoint was 1-year survival. Secondary outcomes included overall survival analysis, device-related adverse events and readmissions. Cumulative follow-up was 10 003 patient-years, with a median follow-up of 1.54 years (interquartile range 0.52-3.15). Patients from higher volume centres more frequently presented in INTERMACS levels 1 and 2, suffered from right heart dysfunction and needed inotropic support. No difference was observed in adjusted 1-year survival. Adjusted overall survival probability was lower in higher volume centres (p = 0.002). In the subgroup analysis of HeartMate 3 devices only, higher volume centres were associated with decreased odds of 1-year survival (adjusted odds ratio 0.43, 95% confidence interval 0.20-0.97, p = 0.041). Similar findings were observed in the cumulative (i.e. learning curve) caseload analyses.
CONCLUSIONS: In patients undergoing LVAD implantation, centre volume was not associated with 1-year survival, but was related to device-related adverse events. Patient profiles differed with respect to centre size. These findings underscore the necessity for ongoing quality improvement initiatives in all centres, regardless of their annual caseload. Efforts are needed to standardize patient selection and preconditioning to further improve patient outcome.

A new accessory was developed to allow implantation of left ventricular assist devices (LVADs) without requiring an anastomosis to the ascending aorta. The accessory combines the LVAD inflow and outflow into a dual-lumen device. Initial prototypes encountered reduced pump performance in vitro, but a second-generation prototype successfully addressed this issue. This feasibility study aimed to demonstrate the anatomic fit, safe implantation, and hemodynamic effectiveness of the LVAD with the accessory. The accessory was implanted in ten female pigs (104 ± 13 kg). Following sternotomy and apical coring under cardiopulmonary bypass, a balloon catheter was retrogradely inserted and exteriorized through the coring site, where it was inflated within the distal third of the outflow graft. It was utilized to pull the accessory\'s outflow across the aortic valve. After LVAD attachment, the catheter was removed. Echocardiography revealed no relevant valve regurgitation post-implantation. During ramp testing, pump flow increased from 3.7 ± 1.2 to 5.4 ± 1.2 L/min. Necropsy confirmed correct accessory placement in nine animals. No valve lesions or device thrombosis were observed. The accessory enabled LVAD implantation without compromising pump performance. Future work includes design refinements for implantation without cardiopulmonary bypass and long-term testing in a chronic heart failure model.

OBJECTIVE: Radiotherapy-induced malfunction of pacemakers and cardiac defibrillators has been reported, and corresponding guidelines have been developed in various countries. Although several studies have reported the effects of radiotherapy in patients with implantable left ventricular assist device (LVAD), its safety remains unclear. Herein, we report three cases of stereotactic ablative radiotherapy (SABR) using CyberKnife for early-stage lung cancer in patients with implantable LVAD.
METHODS: Three patients in their 50s or 60s, including two women and one man, who had LVADs due to dilated or ischemic cardiomyopathy and performance status of 0 or 1, were diagnosed with stage IA2 lung cancer (cT1bN0M0) by imaging only. All three patients were deemed inoperable due to cardiac comorbidity and underwent SABR at the Osaka University Hospital. The total radiation dose was 42-52 Gy, administered in four fractions. All treatment plans were designed to keep the LVAD dose below 2 Gy. In all patients, SABR was completed without acute adverse events or LVAD malfunction. During the follow-up period of 3-29 months, no disease progression or chronic adverse events were observed in any of the patients.
CONCLUSIONS: This case series indicated that SABR using CyberKnife is a safe treatment option for early-stage lung cancer in patients with LVAD by reducing the dose to the LVAD.