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.
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BFBNIB, FZAB, GIS, IJS, IZUM, KILJ, NLZOH, NUK, OILJ, PILJ, PNG, SAZU, SBCE, SBMB, UL, UM, UPUK
Patients with heart failure (HF) are at an increased risk of hospital admissions. The aim of this report is to describe the feasibility, safety and accuracy of a novel wireless left atrial pressure ...(LAP) monitoring system in patients with HF.
The V-LAP Left Atrium Monitoring systEm for Patients With Chronic sysTOlic & Diastolic Congestive heart Failure (VECTOR-HF) study is a prospective, multicenter, single-arm, open-label, first-in human clinical trial to assess the safety, performance and usability of the V-LAP system (Vectorious Medical Technologies) in patients with New York Heart Association class III HF. The device was implanted in the interatrial septum via a percutaneous, trans-septal approach guided by fluoroscopy and echocardiography. Primary endpoints included the successful deployment of the implant, the ability to perform initial pressure measurements and safety outcomes.
To date, 24 patients have received implants of the LAP-monitoring device. No device-related complications have occurred. LAP was reported accurately, agreeing well with wedge pressure at 3 months (Lin concordance correlation coefficient = 0.850). After 6 months, New York Heart Association class improved in 40% of the patients (95% CI = 16.4%-63.5%), while the 6-minute walk test distance had not changed significantly (313.9 ± 144.9 vs 232.5 ± 129.9 meters; P = 0.076).
The V-LAP left atrium monitoring system appears to be safe and accurate.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
AKI is a known complication of PCI and is associated with higher rates of adverse events. We assessed temporal trends in rates of AKI, factors associated with risk of AKI and prognosis.
From a ...prospective registry of patients undergoing PCI at two hospitals of the Rabin Medical Center, 15,153 consecutive patients were assessed at two time periods: 2006–2012 and 2012–2018. AKI was defined as either a relative elevation of ≥25% in serum creatinine or an absolute elevation of ≥0.5 mg/dl in serum creatinine at 48 h post PCI.
Data for 7913 patients from 2006 to 2012 and 7240 during 2012–2018 was available for analysis. Mean age was 65.0 ± 11.9y and 66.0 ± 12.3y (p < 0.001) and baseline creatinine was 1.08 ± 0.87 mg/dl and 1.15 ± 0.97 mg/dl, respectively (p < 0.001). Rates of AKI were 11.1% in the early and 7.3% in the late period (p < 0.001). Following adjustment, risk of AKI was lower in the late period (OR- 0.72; 95% CI 0.61–0.85, p < 0.001). AKI was associated with increased MACE (HR 1.62; 95% CI 1.44–1.82, p < 0.001 for the early period and HR 2.11; 95% CI 1.80–2.46, P < 0.001 for the late period) and death (HR 1.86; 95% CI 1.64–2.11, p < 0.001; HR 2.4; 95% CI 2.02–2.86; p < 0.001) in both time periods.
Over time, there was an improvement in the rates of post-PCI AKI. Increased adverse outcomes were evident at both periods. Further research is warranted, to further reduce peri-procedural AKI which is associated with impaired prognosis.
•Acute kidney injury (AKI) is a known complication of percutaneous coronary intervention (PCI).•The rates of AKI post PCI has decreased from 11.1% between the years 2006–2012 to 7.3% in 2012–2018.•Associated risk factors include female gender, advanced age heart failure and peripheral vascular disease.•AKI was associated with increased MACE and death in both time periods.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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.
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FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
Aims
Since the withdrawal of HeartWare (HVAD) from the global market, there is an ongoing discussion if and which patients require prophylactically exchange for a HeartMate 3 (HM3). Therefore, it is ...important to study outcome differences between HVAD and HM3 patients. Because centres differ in patient selection and standard of care, we performed a propensity score (PS)‐based study including centres that implanted both devices and aimed to identify which HVAD patients are at highest risk.
Methods and results
We performed an international multi‐centre study (n = 1021) including centres that implanted HVAD and HM3. PS‐matching was performed using clinical variables and the implanting centre. Survival and complications were compared. As a sensitivity analysis, PS‐adjusted Cox regression was performed. Landmark analysis with conditional survival >2 years was conducted to evaluate long‐term survival differences. To identify which HVAD patients may benefit from a HM3 upgrade, Cox regression using pre‐operative variables and their interaction with device type was performed. Survival was significantly better for HM3 patients (P < 0.01) in 458 matched patients, with a median follow‐up of 23 months. Within the matched cohort, HM3 patients had a median age of 58 years, and 83% were male, 80% of the HVAD patients were male, with a median age of 59 years. PS‐adjusted Cox regression confirmed a significantly better survival for HM3 patients when compared with HVAD, with a HR of 1.46 (95% confidence interval 1.14–1.85, P < 0.01). Pump thrombosis (P < 0.01) and ischaemic stroke (P < 0.01) occurred less in HM3 patients. No difference was found for haemorrhagic stroke, right heart failure, driveline infection, and major bleeding. Landmark‐analysis confirmed a significant difference in conditional survival >2 years after implantation (P = 0.03). None of the pre‐operative variable interactions in the Cox regression were significant.
Conclusions
HM3 patients have a significantly better survival and a lower incidence of ischaemic strokes and pump thrombosis than HVAD patients. This survival difference persisted after 2 years of implantation. Additional research using post‐operative variables is warranted to identify which HVAD patients need an upgrade to HM3 or expedited transplantation.
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FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
Ventricular fibrillation, a life‐threatening ventricular arrhythmia, may result in pulselessness, loss of consciousness and sudden cardiac death. In this case report, we describe our experience in ...managing a 54‐year‐old man with HeartMate3 left ventricular assist device (LVAD) as a bridge to transplantation due to dilated non‐ischemic cardiomyopathy, presenting with incessant ventricular arrhythmia for 35 days despite multiple attempts to restore normal rhythm with external direct current cardioversion and anti‐arrhythmic medications. The patient remained stable in ventricular arrhythmia with no progression to asystole, but hemodynamic collapse due to right heart failure occurred in the third week. Combined use of two mechanical circulatory support devices (LVAD with VA ECMO) was needed to achieve haemodynamic and metabolic stability, eventually leading to successful heart transplantation in the index admission. The patient was discharged home 2 weeks after transplantation in good clinical condition.
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FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
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.
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FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
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.
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FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
Since the diagnosis of cardiac amyloidosis (CA) is often delayed, echocardiographic findings are frequently indicative of advanced cardiomyopathy. We aimed to describe early echocardiographic ...features in patients subsequently diagnosed with CA. Preamyloid diagnosis echocardiographic studies were screened for structural and functional parameters and stratified according to the pathogenetic subtype (immunoglobulin light-chain AL or amyloid transthyretin ATTR). Abnormalities were defined based on published guidelines. Our cohort included 75 CA patients of whom 42 (56%) were diagnosed with AL and 33 (44%) with ATTR. Forty-two patients had an earlier echocardiography exam available for review. Patients presented with increased wall thickness (1.3 interquartile range {IQR} 1.0, 1.5 cm) ≥3 years before the diagnosis of CA and relative wall thickness was increased (0.47 IQR 0.41, 0.50) ≥7 years prediagnosis. One to 3 years before CA diagnosis restrictive left ventricular (LV) filling pattern was present in 19% of patients and LV ejection fraction ≤50% was present in 21% of patients. Right ventricular dysfunction was detected concomitantly with disease diagnosis. The echocardiographic phenotype of ATTR versus AL-CA showed increased relative wall thickness (0.74 IQR 0.62, 0.92 versus 0.62 IQR 0.54, 0.76, p = 0.004) and LV mass index (144 IQR 129, 191 versus 115 IQR 105, 146 g/m2, p = 0.020) and reduced LV ejection fraction (50 IQR 44, 58 versus (60 IQR 53, 60%, p = 0.009) throughout the time course of CA progression, albeit survival time was similar. In conclusion, increased wall thickness and diastolic dysfunction in CA develop over a time course of several years and can be diagnosed in their earlier stages by standard echocardiography.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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