Barzen Gina, Rieber Finn, Stangl Karl, Hahn Katrin, Spethmann Sebastian
Deutsches Herzzentrum der Charité - Department of Cardiology, Angiology and Intensive Care Medicine, Charitéplatz 1, 10117 Berlin, Germany; Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Germany; Amyloidosis Center Charité Berlin (ACCB), Charité - Universitätsmedizin Berlin, Germany; DZHK (German Centre for Cardiovascular Research), partner site Berlin, Germany.
Deutsches Herzzentrum der Charité - Department of Cardiology, Angiology and Intensive Care Medicine, Charitéplatz 1, 10117 Berlin, Germany; Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Germany; Amyloidosis Center Charité Berlin (ACCB), Charité - Universitätsmedizin Berlin, Germany.
Vaccine. 2024 Feb 6;42(4):723-726. doi: 10.1016/j.vaccine.2023.12.041. Epub 2023 Dec 28.
Amyloidosis is a rare disease in which malformed proteins are deposited in tissues occurring mostly commonly in older age. These deposits can lead to severe organ dysfunction e.g. in the myocardium with great impact on prognosis. The Covid-19 pandemic has caused excess mortality worldwide since 2020. Risk factors for a severe course include pre-existing cardiac diseases like heart failure and advanced age. Therefore, vaccination against Sars-CoV2 viruses is highly recommended for patients with cardiac amyloidosis. However, since there are no specific data on mRNA vaccines in patients with cardiac amyloidosis, some patients have concerns about cardiac adverse events following immunization (AEFI), such as myocarditis.
The purpose of the study is to assess the safety and efficacy of mRNA vaccines in patients with cardiac amyloidosis.
Patients of the Amyloidosis Center Charité Berlin (ACCB) were assessed about the vaccination, its tolerability and clinical effectiveness. To date, we included 62 patients (54 men) with a median age of 82,5 years (range 37 to 92). 46 patients had wtATTR amyloidosis, ten patients had hATTR amyloidosis, and six patients had AL amyloidosis. The mean systolic left ventricular function was 51% (range 30 to 62) with a mean global strain of -11,5% (range -18,5 to -3,1). The mean NT-pro-BNP was 1145 ng/l (range 24 to 48297).
59 patients were triple vaccinated and three patients so far are double vaccinated. Three of the patients were unvaccinated. 171 of the vaccine doses administered were mRNA vaccines and eight doses were a viral vector-vaccine. None of the patients reported severe side effects. Thirteen patients reported feeling of pressure and pain at the injection site after vaccination and four patients had fever of maximum two days, eight patients reported lower general condition of maximum five days. One patient reported malaise for 14 days after each vaccination, which resolved spontaneously. There was no clinical or laboratory evidence of suspected vaccine-induced myocarditis. Five patients reported of a COVID-19 breakthrough infection, all of which with a mild course of disease. None of the patients had symptoms of worsening heart failure in temporal relation to the vaccination. Most of the vaccinations (103) were performed at an official vaccination center, 59 were performed at a general practitioner.
In patients with cardiac amyloidosis, mRNA vaccines for COVID-19 are safe with respect to severe cardiac adverse events and show effective protection against clinically relevant SARS-CoV2 infection.
淀粉样变性是一种罕见疾病，其中畸形蛋白沉积在组织中，最常见于老年人。这些沉积物可导致严重的器官功能障碍，例如在心肌中，对预后有很大影响。自2020年以来，新冠疫情已在全球范围内导致超额死亡。重症病程的风险因素包括心力衰竭等既往存在的心脏病和高龄。因此，强烈建议心脏淀粉样变性患者接种针对严重急性呼吸综合征冠状病毒2（SARS-CoV2）的疫苗。然而，由于尚无关于心脏淀粉样变性患者接种信使核糖核酸（mRNA）疫苗的具体数据，一些患者担心免疫接种后的心脏不良事件（AEFI），如心肌炎。
本研究的目的是评估mRNA疫苗在心脏淀粉样变性患者中的安全性和有效性。
对柏林夏里特医院淀粉样变性中心（ACCB）的患者进行了疫苗接种情况、耐受性和临床疗效的评估。截至目前，我们纳入了62例患者（54例男性），中位年龄为82.5岁（范围37至92岁）。46例患者为野生型转甲状腺素蛋白淀粉样变性（wtATTR），10例患者为遗传性转甲状腺素蛋白淀粉样变性（hATTR），6例患者为轻链淀粉样变性（AL）。左心室平均收缩功能为51%（范围30至62），平均整体应变率为-11.5%（范围-18.5至-3.1）。平均N末端脑钠肽前体（NT-pro-BNP）为1145纳克/升（范围24至48297）。
59例患者完成了三针接种，3例患者目前完成了两针接种。3例患者未接种疫苗。共接种了171剂mRNA疫苗和8剂病毒载体疫苗。没有患者报告严重副作用。13例患者报告接种疫苗后注射部位有压迫感和疼痛，4例患者发热最多两天，8例患者报告全身状况较差最多五天。1例患者每次接种疫苗后报告不适14天，症状自行缓解。没有临床或实验室证据表明存在疑似疫苗诱导的心肌炎。5例患者报告发生了新冠病毒突破性感染，所有感染病程均较轻。没有患者在接种疫苗后出现心力衰竭恶化的症状。大多数疫苗接种（103次）在官方疫苗接种中心进行，59次在全科医生处进行。
对于心脏淀粉样变性患者，新冠mRNA疫苗在严重心脏不良事件方面是安全的，并且对临床相关的SARS-CoV2感染显示出有效的保护作用。
