Self-care behaviours of patients with left ventricular assist devices in Israel: changes during the COVID-19 pandemic.

AIMS: Left ventricular assist devices (LVADs) support the hearts of patients with advanced heart failure. Following LVAD implantation, patients face a complex regimen of self-care behaviours including self-care maintenance, self-care monitoring and self-care management. However, during the COVID-19 pandemic, symptoms of anxiety and depression may have interfered with their self-care. Currently, little is known on how specific self-care behaviours of LVAD-implanted patients changed during the COVID-19 pandemic. We aim to describe the changes in self-care behaviours among patients with an implanted LVAD in Israel during the COVID-19 pandemic and explore the factors related to self-care behaviour change. METHODS: A prospective observational cross-sectional study design. A convenience sample of 27 Israeli LVAD-implanted patients (mean age 62.4 ± 9, 86% male, 78.6% living with a partner) completed the LVAD Self-Care Behaviour Scale (1 = never to 5 = always) and Hospital Anxiety and Depression Scale (0 = not at all to 3 = most of the time). Data were collected before and after the onset of the COVID-19 pandemic in Israel. Statistical analyses included paired t-tests, Pearson's correlations, and one-way repeated measures ANOVAs. RESULTS: During the COVID-19 pandemic, a significant decrease was found in patients' adherence to checking and recording their LVAD speed, flow, power and PI (Pulsatility Index) (P = 0.05), checking their INR (P = 0.01), and daily weighing (P < 0.01). The prevalence of some behaviours (e.g. regularly exercising) increased in some patients and decreased in others. Patients living without a partner worsened their adherence to some of the self-care behaviours (e.g. taking medicines as prescribed), compared with those living with a partner (Mb  = 5.0 ± 0 and Md  = 5.0 ± 0, delta = 0 vs. Mb  = 5.0 ± 0 and Md  = 4.6 ± 0.9, delta = -0.4, respectively; F = 4.9, P = 0.04). Women, and not men, tended to improve their adherence to the self-care behaviour such as avoiding kinking, pulling, or moving the LVAD driveline at the exit site (Mb  = 4.0 ± 1.0 and Md  = 5.0 ± 0, delta = 1.0 vs. Mb  = 4.5 ± 0.9 and Md  = 4.4 ± 1.2, delta = -0.1, F = 4.7, P = 0.04, respectively). In total, 41% (11) patients reported neither anxiety nor depression, 11% (3) reported anxiety, 15% (4) reported depression, and 44% (12) reported both anxiety and depression. No associations between anxiety and/or depression and self-care behaviours were found. CONCLUSIONS: Priorities in self-care behaviours among patients with implanted LVAD changed after the onset of the COVID-19 pandemic. Factors that assisted with adherence to self-care behaviours included living with a partner and being female. The current results may guide further research on identifying behaviours that are at risk of not being maintained during a time of emergency.

Improved immunogenicity following the third dose of BNT162b2 mRNA vaccine in heart transplant recipients.

OBJECTIVES: The immunogenicity of two-dose severe acute respiratory syndrome coronavirus 2 vaccine is lower among heart transplant (HTx) recipients, compared with the general population. Our aim was to assess the immunogenicity of a third-dose vaccine in HTx recipients. METHODS: This is a prospective cohort study of HTx recipients who received a third dose of the BNT162b2 vaccine. Immunogenicity was assessed by serum levels of anti-spike immunoglobulin G (S-IgG), taken at baseline and 14-28 days after the third dose. Titres above 50 U/ml were interpreted positive. RESULTS: We Included 42 HTx recipients at a median age of 65 years [interquartile range (IQR) 58-70]. At baseline, the median of 27 days (IQR 13-42) before the third dose and the median titre of the whole group was 18 U/ml (IQR 4-130). Only 14 patients (33%) were S-IgG seropositive. After the third dose, the proportion of seropositive patients increased significantly to 57% (P = 0.05) and the median titre increased significantly to 633 U/ml (IQR 7-6104, P < 0.0001). Younger age at HTx (OR per 1-year decrease 1.07, P = 0.05), low tacrolimus serum level (OR per 1-unit decrease 2.28, P = 0.02), mammalian target of rapamycin use (OR 13.3, P = 0.003), lack of oral steroids use (OR 4.17, P = 0.04) and lack of calcineurin inhibitor use (71% of responders vs 100% non-responders received calcineurin inhibitors, P = 0.01) were predictors of seropositive result after the third dose. However, no significant association was detected following adjustment for baseline S-IgG titre. CONCLUSIONS: Third-dose booster of BNT162b2 vaccine significantly increased immunogenicity among HTx recipients who previously received a two-dose vaccine.

Ventricular Assist Devices: Challenges of the One-device Era.

Heart failure (HF) is linked to to high mortality rates and recurrent hospitalisations despite medical and device-based achievements. The use of left ventricular assist devices (LVADs) has improved survival among patients with advanced HF. Significant progress has been achieved with the new generation of continuous-flow devices, particularly with the fully magnetically levitated HeartMate 3. In June 2021, Medtronic announced the abrupt withdrawal of the HeartWare device from the market. This decision has introduced a new era in which the field of mechanical support for advanced HF patients is dominated by a single device - the HeartMate 3. The direct clinical and economic consequences of this change will necessitate new surgical considerations. Because of the expected need for HeartWare device replacement in small patients, new surgical techniques and device adaptation will be needed. The new single-device era will hopefully encourage scientists and engineers to create innovations in the advanced HF arena. Special considerations should be taken during the COVID-19 pandemic when treating patients with LVADs.

Exergaming in patients with a left ventricular assist device: a feasibility study.

AIMS: Exercise games (exergames) have been recently proposed as a mode of facilitating physical activity in patients with chronic diseases. Although patients supported with left ventricular assist devices (LVADs) benefit from physical activity, specific LVAD-related issues hinder their ability to exercise properly. The objective of this study was to assess the feasibility and safety of exergaming in LVAD-supported patients. METHODS AND RESULTS: Eleven LVAD-supported patients were enrolled in a 4 week exergaming programme using Nintendo Wii console with five sport games. Patients were instructed to play for 30 min a day, 5 days a week. Data on exercise capacity and exergaming were collected by using the 6 min walk test (6MWT) and a daily self-report diary, respectively. Feasibility of using the console and its safety was assessed by a semi-structured patient interview. Quality of life was assessed by the Minnesota Living with Heart failure Questionnaire (MLHFQ) and the Cantril's Ladder of Life. Safety was assessed by patient's report in interview and diary. The study group consisted of 10 male patients and 1 female patient, mean age of 67 ± 7 years, of whom 10 were supported with the HeartMate 3 LVAD for a median of 10 (interquartile range 3, 21) months. Baseline exercise capacity assessed by the 6MWT ranged from 240 to 570 m (mean 448 ± 112). After 4 weeks of exergaming, 6MWT distance increased from a mean of 448 ± 112 (evaluated in six patients) to 472 ± 113 m (P = 0.023). Patients' Cantril's Ladder of Life score improved numerically from an average of 6.13 to 7.67, as did their MLHFQ score from 45.9 ± 27 to 38.7 ± 18, with higher and lower scores, respectively, reflecting higher quality of life. No specific LVAD-related safety issues regarding exergaming were reported. CONCLUSIONS: Exergaming was found to be a safe and feasible mode for encouraging physical activity in LVAD-supported patients and carries a potential for improving exercise capacity and quality of life in these patients. Larger scale studies are warranted to further investigate the effect of exergaming in this patient population.

Ventricular Assist Devices: Challenges of the One-device Era

Heart failure (HF) is linked to to high mortality rates and recurrent hospitalisations despite medical and device-based achievements. The use of left ventricular assist devices (LVADs) has improved survival among patients with advanced HF. Significant progress has been achieved with the new generation of continuous-flow devices, particularly with the fully magnetically levitated HeartMate 3. In June 2021, Medtronic announced the abrupt withdrawal of the HeartWare device from the market. This decision has introduced a new era in which the field of mechanical support for advanced HF patients is dominated by a single device – the HeartMate 3. The direct clinical and economic consequences of this change will necessitate new surgical considerations. Because of the expected need for HeartWare device replacement in small patients, new surgical techniques and device adaptation will be needed. The new single-device era will hopefully encourage scientists and engineers to create innovations in the advanced HF arena. Special considerations should be taken during the COVID-19 pandemic when treating patients with LVADs.

Heart failure during the COVID-19 pandemic: clinical, diagnostic, management, and organizational dilemmas.

The coronavirus 2019 (COVID-19) infection pandemic has affected the care of patients with heart failure (HF). Several consensus documents describe the appropriate diagnostic algorithm and treatment approach for patients with HF and associated COVID-19 infection. However, few questions about the mechanisms by which COVID can exacerbate HF in patients with high-risk (Stage B) or symptomatic HF (Stage C) remain unanswered. Therefore, the type of HF occurring during infection is poorly investigated. The diagnostic differentiation and management should be focused on the identification of the HF phenotype, underlying causes, and subsequent tailored therapy. In this framework, the relationship existing between COVID and onset of acute decompensated HF, isolated right HF, and cardiogenic shock is questioned, and the specific management is mainly based on local hospital organization rather than a standardized model. Similarly, some specific populations such as advanced HF, heart transplant, patients with left ventricular assist device (LVAD), or valve disease remain under investigated. In this systematic review, we examine recent advances regarding the relationships between HF and COVID-19 pandemic with respect to epidemiology, pathogenetic mechanisms, and differential diagnosis. Also, according to the recent HF guidelines definition, we highlight different clinical profile identification, pointing out the main concerns in understudied HF populations.

Management of Patients with Left Ventricular Assist Device during the COVID-19 Pandemic.

The novel coronavirus disease 2019 (COVID-19) is an infectious disease with multi-organ involvement, including the cardiovascular system. The disease may cause several cardiovascular complications, and may increase morbidity and mortality among patients with background cardiovascular disease. Patients with advanced heart failure are often treated with left ventricular assist device (LVAD), and represent a unique population mandating multi-disciplinary approach. Several aspects of COVID-19 should be taken into account in LVAD implants, including right ventricular involvement, hemodynamic alterations, thromboembolic and haemorrhagic complications, and the psychological effects of social isolation. Patients with VAD and suspected COVID-19 should be transferred to specialized centers for better management of complications. Here, we review the implications of COVID-19 pandemic on LVAD patients with our recommendations for appropriate management.

Six-months immunogenicity of BNT162b2 mRNA vaccine in heart transplanted and ventricle assist device-supported patients.

AIMS: To assess the 6 months immunogenicity to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mRNA vaccine in a population of heart transplanted (HTx) recipients and left ventricular assist device (LVAD)-supported patients. METHODS AND RESULTS: A prospective single-centre cohort study of HTx recipients and LVAD-supported patients who received a two-dose SARSCoV-2 mRNA vaccine (BNT162b2, Pfizer-BioNTech). Whole blood for anti-spike IgG (S-IgG) antibodies were drawn at 6 months after the first vaccine dose. S-IgG data at 6 weeks were available for a subgroup of HTx recipients. S-IgG ≥ 50 AU/mL were interpreted positive. The cohort included 53 HTx recipients and 18 LVAD-supported patients. The median time from HTx or LVAD implantation to the 1st vaccine dose was 90 (IQR 30, 172) months and 22 (IQR 6, 78) months, respectively. The seropositivity rates of S-IgG antibodies and their titre levels in HTx recipients and LVAD-supported patients were 45% and 83% respectively, (P = 0.006), and 35 (IQR 7, 306) AU/mL and 311 (IQR 86, 774) AU/mL, respectively, (P = 0.006). Reduced SARSCoV-2 vaccine immunogenicity in HTx recipients was associated with older age [odds ratio (OR) 0.917 confidence interval (CI 0.871, 0.966), P = 0.011] and with the use of anti-metabolites-based immunosuppressive regimens [OR 0.224 (CI 0.065, 0.777), P = 0.018]. mTOR inhibitors were associated with higher immunogenicity [OR 3.1 (CI 1.01, 9.65), P = 0.048]. Out of 13 HTx recipients who were S-IgG seropositive at 6 weeks after the first vaccine dose, 85% remained S-IgG seropositive at 6 month follow-up. CONCLUSIONS: At 6 months post-vaccination, S-IgG immunogenicity in HTx recipients is low, particularly in older HTx recipients and in those treated with anti-metabolites drugs.

Immunogenicity of the BNT162b2 mRNA vaccine in heart transplant recipients - a prospective cohort study.

AIMS: To assess the short-term immunogenicity to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mRNA vaccine in a population of heart transplant (HTx) recipients. A prospective single-centre cohort study of HTx recipients who received a two-dose SARS-CoV-2 mRNA vaccine (BNT162b2, Pfizer-BioNTech). METHODS AND RESULTS: Whole blood for anti-spike IgG (S-IgG) antibodies was drawn at days 21-26 and at days 35-40 after the first vaccine dose. Geometric mean titres (GMT) ≥50 AU/mL were interpreted positive. Included were 42 HTx recipients at a median age of 61 [interquartile range (IQR) 44-69] years. Median time from HTx to the first vaccine dose was 9.1 (IQR 2.6-14) years. Only 15% of HTx recipients demonstrated the presence of positive S-IgG antibody titres in response to the first vaccine dose [GMT 90 (IQR 54-229) AU/mL]. Overall, 49% of HTx recipients induced S-IgG antibodies in response to either the first or the full two-dose vaccine schedule [GMT 426 (IQR 106-884) AU/mL]. Older age [68 (IQR 59-70) years vs. 46 (IQR 34-63) years, P = 0.034] and anti-metabolite-based immunosuppression protocols (89% vs. 44%, P = 0.011) were associated with low immunogenicity. Importantly, 36% of HTx recipients who were non-responders to the first vaccine dose became S-IgG seropositive in response to the second vaccine dose. Approximately a half of HTx recipients did not generate S-IgG antibodies following SARS-CoV-2 two-dose vaccine. CONCLUSIONS: The generally achieved protection from SARS-CoV-2 mRNA vaccination should be regarded with caution in the population of HTx recipients. The possible benefit of additive vaccine should be further studied.

A rise in left atrial pressure detected by the V-LAP™ system for patients with heart failure during the coronavirus disease 2019 pandemic.

During the coronavirus disease 2019 (COVID-19) pandemic, many patients refrained from inpatient medical care. For those inflicted with heart failure (HF), the risk of repeat hospitalizations is particularly high in case of infection. This presents an important opportunity for remote monitoring of haemodynamic data for these patients, in order to detect and treat accordingly. The aim of the present case is to report of the first measurements of a novel wireless left atrial pressure (LAP) monitoring system, the V-LAP™ (Vectorious Medical Technologies, Ltd), during the COVID-19 pandemic. The V-LAP™ Left Atrium Monitoring systEm for Patients With Chronic sysTOlic & Diastolic Congestive heart Failure (VECTOR-HF) is a first-in-man clinical study assessing the safety and feasibility of the V-LAP™ monitoring system. Our first patient, a 59-year-old man with severe ischaemic cardiomyopathy (left ventricular ejection fraction -30%) was enrolled prior to the COVID-19 outbreak. As per protocol, both the patient and the medical team were blinded to the results in the first 3 months after implantation. We were able to witness the LAP during the pandemic, as the patient remained undertreated, demonstrating a gradual increase from a mean pressure of 6.56 to 19.4 mmHg, as well as prominent V waves, before the data became available to the medical team and the patient was treated accordingly. Thereafter, pressures have returned to low values. This case demonstrated the feasibility of remote monitoring of LAP using the V-LAP™ system, as well as the potential benefit of remote care of HF patients.