Long-term Left Ventricular Assist Device Research Articles

The effect of long-term left ventricular assist device support on flow-sensitive plasma microRNA levels

BackgroundImplantation of current generation left ventricular assist devices (LVADs) in the treatment of end-stage heart failure (HF), not only improves HF symptoms and end-organ perfusion, but also leads to cellular and molecular responses, presumably in response to the continuous flow generated by these devices. MicroRNAs (miRNAs) are important post-transcriptional regulators of gene expression in multiple biological processes, including the pathogenesis of HF. In our study, we examined the influence of long-term LVAD support on changes in flow-sensitive miRNAs in plasma. Materials and methodsBlood samples from patients with end-stage heart failure (N = 33; age = 55.7 ± 11.6 years) were collected before LVAD implantation and 3, 6, 9, and 12 months after implantation. Plasma levels of the flow-sensitive miRNAs; miR-10a, miR-10b, miR-146a, miR-146b, miR-663a, miR-663b, miR-21, miR-155, and miR-126 were measured using quantitative PCR. ResultsIncreasing quantities of miR-126 (P < 0.03) and miR-146a (P < 0.02) was observed at each follow-up visit after LVAD implantation. A positive association between miR-155 and Belcaro score (P < 0.04) and an inverse correlation between miR-126 and endothelial function, measured as the reactive hyperemia index (P < 0.05), was observed. ConclusionsOur observations suggest that after LVAD implantation, low pulsatile flow up-regulates plasma levels of circulating flow-sensitive miRNAs, contributing to endothelial dysfunction and vascular remodeling.

Levels of Trimethylamine N-Oxide Remain Elevated Long Term After Left Ventricular Assist Device and Heart Transplantation and Are Independent From Measures of Inflammation and Gut Dysbiosis.

Trimethylamine N-oxide (TMAO)-a gut-derived metabolite-is elevated in heart failure (HF) and linked to poor prognosis. We investigated variations in TMAO in HF, left ventricular assist device (LVAD), and heart transplant (HT) and assessed its relation with inflammation, endotoxemia, oxidative stress, and gut dysbiosis. We enrolled 341 patients. TMAO, CRP (C-reactive protein), IL (interleukin)-6, TNF-α (tumor necrosis factor alpha), ET-1 (endothelin-1), adiponectin, lipopolysaccharide, soluble CD14, and isoprostane were measured in 611 blood samples in HF (New York Heart Association class I-IV) and at multiple time points post-LVAD and post-HT. Gut microbiota were assessed via 16S rRNA sequencing among 327 stool samples. Multivariable regression models were used to assess the relationship between TMAO and (1) New York Heart Association class; (2) pre- versus post-LVAD or post-HT; (3) biomarkers of inflammation, endotoxemia, oxidative stress, and microbial diversity. ln-TMAO was lower among HF New York Heart Association class I (1.23 [95% CI, 0.52-1.94] µM) versus either class II, III, or IV (1.99 [95% CI, 1.68-2.30], 1.97 [95% CI, 1.71-2.24], and 2.09 [95% CI, 1.83-2.34] µM, respectively; all P<0.05). In comparison to class II-IV, ln-TMAO was lower 1 month post-LVAD (1.58 [95% CI, 1.32-1.83] µM) and 1 week and 1 month post-HT (0.97 [95% CI, 0.60-1.35] and 1.36 [95% CI, 1.01-1.70] µM). ln-TMAO levels in long-term LVAD (>6 months: 1.99 [95% CI, 1.76-2.22] µM) and HT (>6 months: 1.86 [95% CI, 1.66-2.05] µM) were not different from symptomatic HF. After multivariable adjustments, TMAO was not associated with biomarkers of inflammation, endotoxemia, oxidative stress, or microbial diversity. TMAO levels are increased in symptomatic HF patients and remain elevated long term after LVAD and HT. TMAO levels were independent from measures of inflammation, endotoxemia, oxidative stress, and gut dysbiosis.

Changes of Aortic Tissue MicroRNA/mRNA Expression in Patients with Long-Term Left Ventricular Assist Device

Purpose Attenuation of physiological pulsatility after continuous flow left ventricular assist device (LVAD) implantation has been reported as a contributor to alteration of aortic wall morphology and function. MicroRNAs are non-coding RNAs that act to regulate translation of messenger RNA (mRNA) into proteins and are fine-tuners of gene expression in response to pathophysiological stimuli. Differences in gene expression (mRNA) and in post-transcriptional regulators (microRNAs) could reflect biological response to exposure to the low pulsatile environment. We hypothesized that pulsatility deficit caused by LVAD may influence miRNA/mRNA expression in aortic tissue. The aim of the study was to detect miRNA/mRNA associations in the aortic tissue during LVAD support. Methods Aortic samples were collected at the time of LVAD implant and at heart transplantation in 16 patients (mean age 49.6±16.8 years; 3 females) and examined for miRNA/mRNA profiling. QuantSeq 3′ mRNA-Sequencing was used to examine differences in gene expression. Using human miRNome panels a profile of 752 miRNAs was identified. Results A total of 277 mRNAs were dysregulated after LVAD support (padj Conclusion The study provides additional insight in pathophysiology of vascular changes after LVAD implantation. A significant regulation of mRNAs involved in ECM and collagen fibers organization in response to implantation of LVAD was observed, which may suggest infliction of ECM homeostasis resulting in changes of intrinsic properties of vascular wall and arterial stiffness. Downregulation of miRNAs involved in molecular processes related to immune response, could implicate dysregulation in inflammatory processes after LVAD implantation.

Impact of Type of Left Ventricular Assist Device (LVAD) on Health-Related Quality of Life during Prolonged LVAD Support

Purpose Left ventricular assist devices (LVADs) have emerged as an important treatment option for bridging patients with heart failure to transplant. LVADs have shown improved survival; however, the impact of LVAD type on the quality of life (QoL) while on long-term LVAD support is unknown. We aimed to evaluate the QoL of patients while supported with a LVAD in Japan. Methods 299 patients enrolled in the Japanese Registry for Mechanically Assisted Circulatory Support (J-MACS), who were listed for transplant or likely to be listed, received a LVAD from 2010 to 2018 and had full QoL data, were enrolled. QoL data, such as visual analogue scale (VAS) and EQ-5D-3L by 5 dimensions (5D: mobility, self-care, usual activities, pain/discomfort and anxiety/depression) before and at 3- and 12-months after implantation of a LVAD were obtained from the J-MACS Registry. These patients were divided into 3 groups; primary implantable LVAD (iLVAD) (N=263), primary paracorporeal LVAD (pLVAD) (N=9) and bridge from paracorporeal to implantable LVAD (BTB) (N=27). Results VAS in all groups significantly increased from before to 3- and 12-months after LVAD implantation(p Conclusion QoL as VAS and 5D were significantly improved after implantation of any LVAD type. However, VAS and 5D except anxiety/depression in patients with pLVAD were significantly lower and more problems than those in patients with iLVAD. These differences were eliminated by converting from pLVAD to iLVAD. BTB might be a beneficial treatment option to improve QoL as well as patient's survival.

Lived Experiences and Long-Term Challenges and Needs of Asian Left Ventricular Assist Device Caregivers.

Background: Caregivers are essential for improved outcomes in patients living with left ventricular assist device (LVAD). There is a paucity of research on a long-term LVAD caregivers' experiences and burdens.Objectives: The aim of this study was to explore long-term challenges and needs of LVAD caregivers in the Asian health care setting.Design: We conducted semistructured interviews with caregivers of patients who were currently or previously living with the LVAD.Settings/Subjects: Caregivers were recruited from the National Heart Centre Singapore.Measurements: Interviews were conducted in English and Chinese. All interviews were transcribed verbatim and analyzed based on grounded theory. Chinese interviews were translated to English before transcription.Results: A multiethnic and multireligious sample of 11 caregivers participated. Median caregiving duration was 45 months. Caregivers described long-term challenges that were multifaceted. Misaligned patient expectations, stigmatization and limited social resources within the family and society affected caregivers' coping. Existing gender roles and spiritual and cultural influences shaped how caregivers appraised, made meaning of caregiving, and assessed support. Long-term caregivers' needs included learning from role models, shifting perspectives, enhancing communication between patient and caregivers, advocacy efforts, and holistic medical care.Conclusions: Gender roles as well as cultural and spiritual influences affected coping and access to support in long-term Asian LVAD caregivers. Future interventions should consider culturally relevant approaches to improve well-being and quality of life of caregivers.

Aortic Insufficiency Causes Symptomatic Heart Failure during Left Ventricular Assist Device Support.

De novo aortic insufficiency is often documented during long-term left ventricular assist device (LVAD) support, despite the absence of aortic insufficiency at the time of LVAD implantation. However, whether aortic insufficiency affects long-term mortality and symptomatic heart failure in LVAD-supported patients remains controversial. We aimed to examine whether aortic insufficiency development influenced mortality and symptomatic heart failure following LVAD implantation. Fifty-three patients who underwent durable LVAD implantation between January 1, 2008 and April 31, 2017 were retrospectively examined in a single center institute. After discharge, we performed the echocardiographic examination in accordance with the Japanese registry for the mechanically assisted circulatory support protocol. Aortic insufficiency was graded on an interval scale (severe = 4, moderate = 3, mild = 2, trivial or none = 1). Kaplan-Meier estimates for long-term mortality at the follow-up were generated. We used a logistic regression model to identify risk factors for symptomatic heart failure. The overall median duration of LVAD support was 856.3 ± 430.8 days (range, 12-1,744 days). We did not observe a significant difference in long-term mortality in patients with aortic insufficiency ≥ 3 grade compared with patients with aortic insufficiency < 3 grade (P = 0.767; log-rank). Aortic insufficiency was associated with an increased risk for heart failure event after discharge (odds ratio, 4.12; confidence interval, 1.48-16.93; P = 0.005). Aortic insufficiency was an independent risk factor for symptomatic heart failure and was not associated with long-term mortality. Aortic insufficiency progression was associated with symptomatic heart failure.

Is there a future for the use of left ventricular assist devices in Duchenne muscular dystrophy?

Duchenne muscular dystrophy (DMD) is the most common form of childhood muscular dystrophy resulting in progressive muscle wasting and weakness. With advancements in respiratory care and the use of glucocorticoids, cardiomyopathy has surpassed respiratory compromise as the leading cause of morbidity and mortality in this patient population. As muscular dystrophy remains a relative contraindication to heart transplantation, end-stage heart failure management represents a major therapeutic challenge. Long-term left ventricular assist device (LVAD) therapy has emerged as a promising management strategy to improve the survival and quality of life in DMD cardiomyopathy. Preoperative planning, optimal patient selection, aggressive postoperative rehabilitation, and continued discussion of goals of care are critical considerations for the appropriate use of LVAD in DMD patients with cardiomyopathy.

Abstract 12931: Myocardial Regeneration in End-stage Heart Failure After Left Ventricular Unloading

Introduction: Left Ventricular Assist Devices (LVAD) decrease cardiac mechanical work and metabolic demand and may decrease cardiomyocyte oxidative stress, followed by cell cycle re-entry and cell regeneration. We tested whether LVAD long-term support is associated with myocardial regeneration. Methods: Viability fluorodeoxyglucose (18FDG) - positron-emission tomography scans were performed &gt;3 months after LVAD implantation and every 6 months thereafter. 4 patients aged 18-70 with end-stage non-ischemic (NICM, n=3) or ischemic cardiomyopathy (ICM, n=1) were included. Low metabolic activity myocardial regions of interest (ROI) at &lt;15th percentile of relative 18FDG signal intensity were identified on the baseline scan. Global signal and co-registered low-intensity ROIs were analyzed on subsequent scans vs. baseline. Results: LV ejection fraction ranged 0-35% at baseline. Two patients (LVAD speed 2660 rotations per minute - RPM, output 3.4-4.1 and 5.6-5.9 liters per minute (LPM), respectively) underwent 2 scans before cardiac transplantation, exhibiting borderline increased global signal (1-4%) and significantly increased 18FDG signal in the baseline low-intensity ROI on the follow-up scan (67.7, 75.7%). The other 2 patients (LVAD parameters: 5600 RPM/ 4.6-5.8 LPM; 9200 RPM/ 4.3-4.8 LPM) exhibited decreased global 18FDG signal (10-16%) and increased signal in the co-registered baseline low-intensity ROIs (1.7-21.5%) (Figure). Conclusions: LVAD long-term support is associated with a global decrease in myocardial 18FDG uptake signal over time, and with increased viability signal in baseline low-intensity ROIs, suggestive of myocardial regeneration in metabolically inactive regions. Future research is required to identify patient subgroups that are most likely to exhibit high regeneration potential upon long-term LVAD support.

The Impact of Obesity on Left Ventricular Assist Device Outcomes.

Background and Objectives: The understanding of high body mass index (BMI) and outcomes after Left Ventricular Assist Device (LVAD) implantation continues to evolve and the relationship has not been established yet. In this study, we investigated the effects of obesity (BMI > 30 kg/m2) on post–LVAD implantation outcomes. HeartWare LVAD and Heart Mate III LVAD were implanted. The primary outcome that was measured was mortality (in-hospital and on follow-up). The secondary outcomes that were measured were major adverse events. Materials and Methods: At our institution, the West German Heart and Vascular Center (Essen, Germany), from August 2010 to January 2020, a total of 210 patients received a long-term LVAD. Patients were stratified according to BMI ≥ 30 kg/m2 representing the obesity threshold. The first group (n = 162) had an average BMI of 24.2 kg/m2 (±2.9), and the second group (n = 48) had an average BMI of 33.9 kg/m2 (±3.2). Baseline demographics were analysed alongside comorbidities per group. Results: Overall mortality was not significantly different between the obese group (51.1% n = 24) and the nonobese group (55.2%, n = 85) (p = 0.619). The difference between the mean duration of survival of patients who expired after hospital discharge was insignificant (2.1 years ± 1.6, group 1; 2.6 years ± 1.5, group 2; p = 0.29). In-hospital mortality was unvaried between the two groups: group 1: n = 34 (44% out of overall group 1 deaths); group 2: n = 11 (45.8% out of overall group 2 deaths) (p > 0.05). Postoperative complications were unvaried between the obese and the non-obese group (all with p > 0.05). However, a significant difference was found with regards to follow-up neurological complications (18.5% vs. 37.8%, p = 0.01) and LVAD thrombosis (14.7% vs. 33.3%, p = 0.01), as both were higher in the obese population. Conclusion: Obesity does not form a barrier for LVAD implantation in terms of mortality (in-hospital and on follow up). However, a significantly higher incidence of follow-up LVAD thrombosis and neurological complications has been found in the obese group of patients.

CLINICAL EFFECTIVENESS OF CONTINUOUS-FLOW LVAD THERAPY IN NON-ISCHEMIC VERSUS ISCHEMIC CARDIOMYOPATHY: A SYSTEMATIC REVIEW AND META-ANALYSIS

Left ventricular assist devices (LVADs) are being increasingly used to manage patients with symptomatic end-stage heart failure (ESHF) refractory to medical and resynchronization therapies. Although clinicians may be less inclined to consider long-term LVAD therapy in ESHF as a result of non-ischemic cardiomyopathy (NICM) due to potentially greater right ventricular (RV) involvement than ischemic cardiomyopathy (ICM), it is currently unknown whether HF etiology has a clinically meaningful effect on outcomes following LVAD implantation.

Cost-Effectiveness of Long-Term Left Ventricular Assist Device Support: Is the Extra-Welfarist Model Suitable for Advanced Heart Failure?

Cost-Effectiveness of Long-Term Left Ventricular Assist Device Support: Is the Extra-Welfarist Model Suitable for Advanced Heart Failure?

The role of long-term mechanical circulatory support in patients with advanced heart failure.

In patients with end-stage heart failure, advanced therapies such as heart transplantation and long-term mechanical circulatory support (MCS) with a left ventricular assist device (LVAD) have to be considered. LVADs can be implanted as a bridge to transplantation or as an alternative to heart transplantation: destination therapy. In the Netherlands, long-term LVAD therapy is gaining importance as a result of increased prevalence of heart failure together with a low number of heart transplantations due to shortage of donor hearts. As a result, the difference between bridge to transplantation and destination therapy is becoming more artificial since, at present, most patients initially implanted as bridge to transplantation end up receiving extended LVAD therapy. Following LVAD implantation, survival after 1, 2 and 3 years is 83%, 76% and 70%, respectively. Quality of life improves substantially despite important adverse events such as device-related infection, stroke, major bleeding and right heart failure. Early referral of potential candidates for long-term MCS is of utmost importance and positively influences outcome. In this review, an overview of the indications, contraindications, patient selection, clinical outcome and optimal time of referral for long-term MCS is given.

Less Invasive Reoperative Ventricular Assist Device Insertion for Patients With Patent Bypass Grafts

We report our technique for left ventricular assist device insertion that is useful in patients with patent coronary artery bypass grafts or mediastinal adhesions from other previous surgeries. An inverted-T upper hemisternotomy is made at the level of the second or third intercostal space, and with the left sternal section retracted, dissection is carried along the chest wall into the left pleural space. The device is implanted in the left ventricular apex via a left thoracotomy in the fifth or sixth intercostal space. The outflow graft is routed through the left pleural space and anastomosed to the ascending aorta.

Expanding Use of New Technology Creates New Challenges in Preventing and Managing Infections: a Review of Diagnostic and Management Considerations for Infections Among Patients with Long-Term Invasive Devices for Advanced Heart Failure

Although still a relatively new technology, long-term left ventricular assist devices (LVADs) for management of advanced heart failure is rapidly increasing. Initially designed as a bridge to transplant, these invasive devices are increasingly used as a destination therapy, creating unique and long-term infection risks. The aim of this comprehensive review is to highlight current evidence about the prevention, diagnosis, and management of LVAD-specific infections. There are two recent, major societal guidelines (The International Society for Heart and Lung Transplantation, 2017, and the American Society of Transplantation, 2019) specifically on the diagnosis and management of infections in LVAD patients. A third guideline from the European Association for Cardio-Thoracic Surgery (2019) on general LVAD management contains a section on infection management. Recommendations tend to be concordant across the guidelines without major disagreements and suggest that for superficial infections, limited-course durations of antimicrobials are acceptable. For infections of deeper portions of the device, long-term antimicrobial regimens, often with chronic suppressive strategies remain the mainstay of treatment; however, this recommendation is based primarily on expert opinion as high-quality evidence to support best practices remains limited. The role of surgical management remains unknown. Management of long-term, device-related infections in patients with advanced heart failure is challenging and should include input from a multi-disciplinary team of providers to determine the best management strategy. A strong emphasis on best prevention practices is a necessity. With this relatively new technology, evidence-based data to guide best practices remains limited and is an important area of future research.

Concomitant Cardiac Procedures during Implantation of Long-Term Continuous-Flow LVADs: A European Registry for Patients with Mechanical Circulatory Support (EUROMACS) Analysis

There are still discordant data on the effect of concomitant cardiac procedures (CCPs) performed during left ventricular assist device (LVAD) implantation. By investigating on the European Registry for Patients with Mechanical Circulatory Support (EUROMACS) dataset, we identified 2760 patients (pts) who underwent continuous-flow (CF) long-term LVAD implantation. LVAD implantation was associated with a single CCP in 533 pts (19.3%). A propensity score (PS) matching (LVAD pts, n=481 vs. LVAD+CCP pts, n=481) analysis has been perfomed. Intensive care unit (ICU) stay (20.9 vs. 25.5 days, p=0.019) and major bleeding requiring rethoracotomy (4.1% vs. 7.2%, p=0.027) resulted to be more frequent in LVAD+CPP cohort. Hospital mortality (17.4% vs. 22.2%, p=0.063) resulted to be comparable. Only coronary artery bypass grafting (p=0.041, OR 2.03, CI 1.03-4.02) did impact negatively. Extremes of body mass index (BMI), preoperative poor haemodynamics, dependance on inotropes infusion and extracorporeal life support (ECLS) resulted to be risk factors, after adjustment for baseline characteristics. During the mid- to long-term postoperative period, LVAD+CCP population showed higher incidence of bleeding (6.9% vs. 10.8%, p=0.031) and infectious adverse events (9.6% vs. 15.4%, p=0.022), respectively. Follow-up mortality (22.5% vs. 20.3%, p=0.432) resulted to be comparable. Valve surgery concomitant with LVAD implant seemed not to be associated with poor clinical outcomes (p=0.785). Mitral valve repair resulted to be protective in the long-term period (p=0.041), while tricuspid valve repair did not have any influence (p=0.108). No differences were observed by Kaplan-Meier survival analysis in the two cohorts (log-rank p=0.81, PS matched). In summary, performance of CCPs may not increase peri-operative mortality and type of concomitant surgery addressed should be properly weighted. Mid- to long-term survival is not influenced by CCPs. This, however, remains a delicate population to be strictly monitored and homogeneously managed to preserve satisfactory outcomes.

Outcomes Following Discontinuation of Warfarin in Heartmate 3 Patients: A Multi-Center Review

Bleeding complications during left ventricular assist device (LVAD) support pose anticoagulation challenges as risk of discontinuation of anticoagulation, even in the setting of bleeding, may pose an increased risk of subsequent LVAD hemolysis or thrombosis. We assessed whether discontinuation of anticoagulation in HM3 patients whose bleeding concerns preventing anticoagulation would adversely impact outcomes. This multi-center, retrospective review included HeartMate 3 patients implanted between November 2016 and July 2019 for whom warfarin was discontinued. Patient characteristics, reason for anticoagulation discontinuation and subsequent adverse events were collected for all patients. The primary outcome was incidence of pump thrombosis. Secondary outcomes included bleeding events and overall survival. Ten patients were analyzed (80% male, 70% ischemic cardiomyopathy and 80% destination therapy). Preopertively, three patients required warfarin and 3 had a prior history of gastrointestinal bleeding (GIB). Reasons for anticoagulation discontinuation post HM3 placement included: GIB (N=5), hemorrhagic CVA (N=3), gross hematuria (N=1), hemothorax (N=1), and allergy (N=1). Four patients had concomitant Aspirin discontinuation. Time supported with HM3 off anticoagulation ranged from 69 to 961 days, representing 4,869 patient-days in total (Figure 1A). During this follow-up time, one patient experienced an embolic CVA attributed to left atrial appendage clot with subsequent hemorrhagic transformation, and one patient required device exchange for thrombosis. Bleeding also remained a common adverse event (N=5) despite the lack of anticoagulation. These data highlight the complicated hemocompatibility challenges associated with long-term LVAD support in a sub-group of patients. Discontinuation of both Aspirin and Warfarin can be considered in a select group of HM3 patients, but with judicious monitoring for early signs of adverse events.

Long-Term Outcomes of Heartware Left Ventricular Assist Device Decommissioning for Myocardial Recovery

Left ventricular assist device (LVAD) decommissioning reduces the risks associated with long-term LVAD support without subjecting patients to a major explantation operation. However, the long-term outcomes of this strategy are not known. Our unit's LVAD database was reviewed to identify patients who underwent LVAD decommissioning for myocardial recovery from 2009 to 2019. Friedman test was performed to compare left ventricle (LV) function grades over time and repeated measures ANOVA for ejection fraction (EF). Kaplan-Meier analysis was conducted to compare the survival of these patients with the LVAD bridged to transplant and all other LVAD patients. Among the 254 adult LVAD patients, 11 (4.3%) underwent decommissioning for myocardial recovery after assessment at low flow. The median support duration was 940 (IQR 646-1078) days and median follow-up duration 1425 (IQR 776-1774) days. 3 patients (27.3%) died during follow-up, 1 due to heart failure and 2 due to sepsis. 4 patients (36.4%) had LVAD explantation subsequently due to recurrent sepsis. This group's survival was comparable to that of the LVAD bridged to transplant group (p=0.7) and significantly better than that of the all other LVAD group (p=0.0015) (Figure 1). However, after decommissioning, their LV function gradually deteriorated (Figure 2). Selected patients with myocardial recovery would benefit from LVAD decommissioning with favourable long-term outcomes. However, they still face the potential risk of systemic infection and need to be regularly followed up for LV function monitoring and medical therapy optimisation.

Prognostic factors for heart recovery in adult patients with acute fulminant myocarditis and cardiogenic shock supported with extracorporeal membrane oxygenation

BackgroundExtracorporeal membrane oxygenation (ECMO) is an effective support method for acute fulminant myocarditis (AFM) with cardiogenic shock. However, deciding whether to bridge to a left ventricular assist device (LVAD) or to maintain ECMO support until heart recovery is still controversial. Material and methodsThis was a retrospective observational study from a single center. Eighty-eight adults with AFM and ECMO support between 2006 and 2018 were included. The primary endpoint was heart recovery without heart transplantation or long-term LVAD support. ResultsThe heart recovery group contained 43 patients, of whom 41 were discharged after being weaned off ECMO and the other two after LVAD. Five patients with heart transplants and one with long-term LVAD support were discharged, accounting for an overall survival of 55.7%. Multivariate logistic regression revealed that peak CK-MB level, severe intraventricular conduction disturbance (asystole) and malignant arrhythmia (VT or VF) were prognostic factors for nonrecovery (P = .027 and 0.017, respectively), while early intravenous immunoglobulin (IVIG) use before ECMO was highly likely to have a protective effect with a trend toward statistical significance (P = .079). A risk score was developed: 4 points for VT/VF/asystole, 1 point for every 100 μg/L increase in the peak CK-MB level, up to a maximum of 5 points, and −3 points for early IVIG use. The area under the receiver operating characteristic (ROC) curve (AUC) was 0.818. ConclusionHigh CK-MB levels and VT/VF/asystole in patients with AFM are associated with poor heart recovery. Early IVIG use shows a potentially protective effect.

Abnormalities of brain imaging in patients after left ventricular assist device support following explantation

The potential impact of long-term left ventricular assist device (LVAD) support on the brain remains unclear. This study aimed to investigate cerebral microvascular damage in patients after long-term LVAD implantation using magnetic resonance imaging (MRI). We reviewed the medical records of patients after continuous-flow LVAD implantation in our hospital from 2006 to 2016, who underwent brain MRI after LVAD explantation for either transplantation or recovery. Age- and sex-matched healthy controls and patients with chronic heart failure (CHF) were collected from our pooled MRI database. The presence of cerebral microbleeds (CMBs) and cortical superficial siderosis and the severity of white matter hyperintensity (WMH) and cerebral atrophy were compared between patients with prior LVAD and 2 control groups. This study included 49 patients with prior LVAD, 49 healthy controls, and 45 patients with CHF. CMBs and cortical superficial siderosis were detected in 98% (p < 0.001) and 31% (p < 0.001) of patients with prior LVAD, respectively. The number of CMBs was higher in patients with prior LVAD than in the 2 control groups. The severity of the WMH was higher in patients with prior LVAD than in healthy controls but similar to that in patients with CHF. Quantitative analyses of cerebral atrophy revealed a significantly higher bicaudate ratio and cella media index in patients with prior LVAD than in the 2 control groups. Patients after long-term LVAD support showed a higher prevalence of CMBs and cortical superficial siderosis and more severe cerebral atrophy than did controls. These findings may indicate cerebral microvascular damages in long-term LVAD support patients.

Development of an Instrument for Measuring Self-Care Behaviors After Left Ventricular Assist Device Implantation.

Successful long-term left ventricular assist device (LVAD) therapy necessitates a high degree of self-care. We aimed to develop an instrument that measures self-care behaviors in adult patients living with an LVAD. We used the method to develop patient-reported outcomes recommended by the US Food and Drug Administration. Prior to developing the instrument, a literature review was conducted to generate items using the middle-range theory of self-care of chronic illness as a guiding framework. A 2-round Delphi method, involving 17 clinicians with expertise in heart failure and assist devices from the Netherlands, Israel, United States, Canada, and Japan, was used to generate and select items. In the first Delphi survey, the levels of importance, relevance, and clarity of items in the instrument were evaluated. The second Delphi survey was performed to gain consensus on the final selection of items. We also examined face validity. A preliminary 37-item version of the Self-Care Behavior Scale was produced. The first panel judged 33 items as important and relevant, taking out 4 items due to vague wording and duplication and adding in 4 items. In the final 33-item version, 19 items address self-care maintenance behaviors, 10 items address self-care monitoring behaviors, and 4 items address self-care management behaviors. Patients (N = 25) did not have any difficulties understanding items and report any missing items. The 33-item Self-Care Behavior Scale for patients with heart failure having an LVAD has been developed and is ready for further psychometric testing.