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.

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.

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.

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.

Health-related quality of life in left ventricular assist device-supported patients.

AIMS: This study aimed to evaluate the different health-related quality of life (HR-QoL) aspects in patients with both short-term and long-term duration LVAD support at pre-specified time intervals. METHODS AND RESULTS: We performed a single-centre HR-QoL analysis of short-term and long-term LVAD-supported patients using the short version of the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) and the Changes in Sexual Functioning Questionnaire along with a survey to evaluate patients' social and driving routines. Data were collected at baseline and at 6 or 12 month follow-up. Included were 46 patients with a median time from LVAD implantation of 1.1 [inter-quartile range (IQR) 0.5, 2.6] years. The median KCCQ-12 summary score was 56 (IQR 29, 74) with most favourable scores in the symptom frequency domain [75 (IQR 50, 92)] and worse scores in the physical limitation [42 (IQR 25, 75)] and QoL [44 (IQR 25, 75)] domains. No significant changes were apparent during study follow-up [KCCQ-12 summary score 56 (IQR 35, 80)], and no significant correlation between the KCCQ-12 summary score and ventricular assist device-support duration was detected (r = -0.036, P = 0.812). Sexual dysfunction was noted across all domains with a cumulative score of 31 (IQR 22, 42). Seventy-six per cent of patients resumed driving after LVAD implantation, and 43% of patients reported they socialize with family and friends more frequently since surgery. CONCLUSIONS: Short-term and long-term LVAD-supported patients had impaired HR-QoL and sexual function at baseline and at follow-up yet reported an improvement in social interactions and independency. A broader spectrum of patient's reported HR-QoL measures should be integrated into the pre-LVAD implantation assessment and preparation.

Psychometric Testing of the Hebrew Version of the European Heart Failure Self-Care Behaviour Scale.

BACKGROUND: The assessment of self-care behaviour is important for tailoring care to patients and evaluating the effectiveness of heart failure (HF) disease-management programmes. The European HF Self-care Behaviour (EHFScB) scale is a validated instrument used worldwide. AIM: The purpose of the study was to evaluate psychometric properties of the Hebrew version of the nine-item EHFScB scale in Israeli patients with HF. METHOD: To develop the Hebrew version of the EHFScB scale, forward and back translation was performed. The psychometric evaluation was based on data from 102 patients with HF (mean age 61±12 yr, male 75%, New York Heart Association [NYHA] class II 42% and NYHA class III 51%) included in two cross-sectional studies performed in 2007 and 2015-2017 in an Israeli hospital. Content validity, construct validity, known-groups validity, and discriminant validity were assessed. Reliability was evaluated with internal consistency. RESULTS: Content validity and useability were confirmed by HF experts and patients with HF. Construct validity was tested using factor analysis and two factors were extracted (factor 1: consulting behaviour; factor 2: adherence to the regimen). Known-groups validity testing revealed a significant difference before and after an educational intervention in the total score (n=40 [41.6±23.8] vs [67.6±21.8]; p<0.01). A weak correlation between the self-care score and health-related quality of life (r= -0.299, p<0.01) was observed, showing that these concepts were related but not overlapping. Cronbach's alpha was 0.78 for the total scale, 0.76 for factor 1, and 0.68 for factor 2, suggesting that the internal consistency of this scale was acceptable. CONCLUSIONS: Our study provides support for the useability, validity, and reliability of the nine-item Hebrew version of the EHFScB scale.

Monitoring lung resistivity changes in congestive heart failure patients using the bioimpedance technique.

The feasibility of a novel, dedicated system for monitoring lung resistivity in congestive heart failure patients, implementing a hybrid approach of the bioimpedance technique, was assessed in this preliminary study. Thirty-three healthy volunteers and 34 congestive heart failure patients were measured with the PulmoTrace system (CardioInspect, Tel Aviv University, Tel Aviv, Israel) during tidal respiration, and the ability to monitor the respective lung resistivity values was assessed. Mean left and right lung resistivity values of 1205+/-163 and 1200+/-165 ohm.cm for the control group and 888+/-193 and 943+/-187 ohm.cm for the congestive heart failure group were found, indicating a significant (p<2.10(-7)) difference between the two groups. The results of long-term monitoring of two patients during medical treatment are also shown. This hybrid approach system is believed to improve diagnostic capabilities and help physicians to better adjust medication dosage on a frequent basis.