ABSTRACT
Heart transplanted (HT) patients (pts) are poor responders to booster doses;there is an unmet need to find strategies to protect this fragile category of pts in the context of Omicron variants. It has been suggested that MMF could limit the immune response to vaccine. Tixagevimab/cilgavimab (T/C) has been approved for prophylaxis, but there are still few data on its safety and efficacy. We present our experience with T/C and with the reduction of MMF after the third (booster dose). All HT pts followed in our Center after November 2021 (when Omicron became the dominant in our Country) without significant anti-RBD antibodies (<100 ng/ml) after the booster dose were selected: before T/C availability, we reduced of 50% the dose of MMF one week before and after the forth dose if there was no recent rejection;after its availability, we interrupted this approach. The endpoint is the incidence of SARS-CoV-2 infection at two months in both strategies and the safety of T/C. 379 pts (23.1% vaccinated with 4 doses, 62% with 3 doses, 11.5% 2 doses, 3.4% not vaccinated) had 103 infections (4 reinfections), with an incidence of 20.0±2.2% at 6 months from the last dose of vaccine;17.4% were hospitalized, 3 pts (2.9%) died, one of whom was not vaccinated. 24.2% received antivirals, 13.5% sotrovimab without adverse effects and 100% survival.38% of 200 pts had low anti-RBD antibodies after the third dose. Among 84 undergoing to the forth dose, 41/57 for whom antibodies were known had low levels: 8 underwent to MMF reduction, in 23 the dose ws unchanged. The incidence of COVID-19 infection was 18.8±6.9% at two months and 26.5±8.1% at 6 months, with a borderline significant difference between the group were MMF was reduced compared to the one where it was unchanged (p=0.06).28 patients underwent to tixagevimab/cilgavimab (T/C) administration;the incidence of COVID-19 was 6.6±6.4% at two months. No adverse effects were noticed. While confirming the good outcomes of Omicron variants in a HT pts with high prevalence of vaccination and with the actuarial therapies, this small observational study suggests that in patients without detectable anti-RBD antibodies after the booster dose, MMF reduction may be somehow v beneficial, but T/C appears to give a better protection against the infection in the first two months. Larger studies are needed to confirm these results. [ABSTRACT FROM AUTHOR] Copyright of Journal of Heart & Lung Transplantation is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
ABSTRACT
Background. Solid organ transplant (SOT) recipients are at higher risk than general population for complicated COVID-19 course. Moreover COVID-19 vaccination in this setting is associated with a suboptimal immune response. However, the impact of this finding on the risk of breakthrough infection (BI) in SOT recipients has to be yet determined. Methods. Single-center prospective longitudinal cohort of adult SOT recipients who received three doses of mRNA COVID-19 vaccine between February and December 2021 and were followed up to March 30 2022. Patients were tested for antibody response at several timepoints (1 st dose, 2 nd dose, 3+/-1 month after 1 st dose, and 1 month after 3 rd dose). Main endpoints were: i) BI defined as laboratory confirmed SARS-CoV2 infection diagnosed >=14 day after 2 nd dose;ii) positive antibody response (AbR) defined as anti-rapid binding domain titer >=5 U/ml determined by Elecsys Anti-SARS-CoV-2 ECLIA assay (Roche Diagnostics, CH), the last available determination before BI was considered. Results. Study cohort consists of 642 SOT (277 kidney, 191 liver, 144 heart, 37 lung) recipients: 63.9% males, median age 54 +/- 14.5 years. Of them, 111 (17.8%) developed BI, BI rates were 19.9%, 18.1%, 15.2% and 10.8% among liver, heart, kidney and lung transplant recipients, respectively. Positive-AbR was observed in 60% of all patients, but rates varied from 8.7% to 91.3% among patients with BI and without BI, respectively. Predictors of BI infection at multivariable analysis were liver (vs. other grafts) transplant (OR 2.98, 95%CI 1.47-6.03), mycophenolate (1.63, 0.92-2.88) and steroids (1.8, 1.05- 3.33), while positive-AbR (0.61, 0.35-1.04) and age (0.97, 0.95-0.99) were protective. On the other hand, liver transplant (1.94, 1.02-3.69), time from transplant (1.09, 1.05-1.21), and Moderna vaccine (2.32, 1.46-3.70) were associated with positive-AbR, while age (0.97, 0.95-0.98), heart transplant (0.56, 0.33-0.96), mycophenolate (0.65, 0.39-1.06) and steroids (0.39, 0.23-0.65) with lower probability of positive-AbR. Conclusion. Although associated with positive-AbR, liver transplant and younger age were also BI predictors, suggesting the importance of social factors and the controversial role of immune monitoring.
ABSTRACT
Purpose As Italy faced SARS-CoV-2 outbreak as first country outside China, and our hospital converted most of activities into the ones for COVID-19 patients (pts), we had to manage the need for continuing care of advanced heart failure (HF), heart transplant (HT) and LVAD pts. TM was a possible strategy, but its role in this very sick cohort is unknown. Methods During the lockdown (03-05/2020), we decided to make either a phone (PV) or an in presence (IV) visit, selecting for IV pts listed for HT, with LVAD, recently HT, scheduled for a biopsy within 6 months after HT or a RHC for listing eligibility. In PV, we assessed symptoms, blood pressure, drugs, and programmed a subsequent IV. All pts in IV group were triaged by phone for COVID-19 symptoms or contacts and if scheduled for RHC or biopsy received SARS-CoV-2 swab 48 h before the procedure. Study endpoints were: combined incidence at 6 months of MACE (HF hospitalization, CV death and need for anticipated IV) in HF/VAD group, and MACE, rejection and any cause- hospitalization in HT group. Results Among 448 pts (57±12y, 240 HT, 191 HF, 17 LVAD), 52% were managed by PV and a subsequent IV was scheduled after 3±2 months. Pts managed by PV were healthier: in HF-VAD group they were less frequently listed, had less Afib, LVAD (2/17) (p<0.01 all);post-capillary PH (pC-PH) was similarly distributed;in HT group there were less pts transplanted in the last 5 years (15% vs 52%, p<0.01) and numerically less with 2R rejection in the previous 6 months (8.3% vs 27.1%, p=0.13).The PV group had a lower incidence of the endpoints in both HF/VAD and HT cohorts (92.3±2.3% vs 70.3±4.4%;97.0±1.7%vs82.5±4.1%, p<0.01). Overall, the predictors of the endpoints at multivariate analysis were pC-PH and PV (HR: 5.2 and 0.1, p<0.03 both) and a recent 2R rejection (HR: 3.6, p=0.05) in the HF/VAD and HT group respectively.There were no cases of COVID-19 in IV;5 pts got infected at home in a context of infection prevalence of 6/1000 inhabitants in our region and of 40% of hospital beds dedicated to COVID-19 pts. Conclusion In this retrospective study, by reporting an organization set up in a emergency situation, we show that TM can be safely used to manage stable HF, LVAD and HT patients, whereas pC-PH and a recent rejection may identify those needing IV. These data suggest that the availability of devices for monitoring pulmonary pressures may improve safety of PV in HF pts and that TM could be useful not only in a pandemic outbreak but also subsequently.
ABSTRACT
Purpose Left ventricular assist devices (LVAD) have been developed to support cardiocirculatory function in patients with advanced heart failure, who are refractory to optimal medical treatment. This created the need to identify a professional figure for dedicated management of LVAD patients. Methods In this report, we analyzed all the accesses of all consecutive adult LVAD recipients at our outpatient care unit and the impact of VAD coordinator clinical/technical assessment on patients global management, at the time of COVID-19 pandemic in the period January to August 2020 Results During the study period, 19 LVAD patients had overall 357 contacts with the clinic, for different combinations of: advanced driveline dressing (n=280), log file analysis and technical check-up (n=200), clinical visit (n=102), ramp test (n=17). In the majority of accesses, the patient was seen by the VAD coordinator only, (n=238;67%), mainly for driveline dressing, which was associated with technical check-ups in 89 cases.Overall, alarms were managed by technical check-ups and log file analyses in 14 cases (6 high priority alarms, 3 cases of high watt or low flow, and 5 cases of low-priority alarms). Ramp tests were performed during right heart catheterization, with contextual echocardiography performed by the VAD coordinator: in 11 out of 17 cases the ramp test led to medical therapy or LVAD settings optimization. Conclusion LVAD patients need frequent outpatients dedicated admissions for proper monitoring. The VAD coordinator is a key healthcare professional representing the main interface for LVAD patients, in support of physicians’ throughout the duration of mechanical support, to preserve optimal outcomes.