Introduction

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 side effects, such as myocarditis.

Purpose

The purpose of the study is to assess the safety and efficacy of mRNA vaccines in patients with cardiac amyloidosis.

Methods

Patients of the Amyloidosis Center Charité Berlin (ACCB) were assessed about the vaccination, its tolerability and clinical efficacy. To date, we included 65 patients (57 men) with a mean age of 78,2 years (range 37 to 92). 49 patients had wtATTR amyloidosis, ten patients had hATTR amyloidosis, and six patients had AL amyloidosis. The mean systolic left ventricular function was 49,8% (range 30 to 62) with a mean global strain of -10,8% (range -18,5 to -3,1). The mean NT-pro-BNP was 3948ng/l (range 24 to 48297).

Results

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. Eleven patients reported feeling of pressure and pain at the injection site after vaccination and two patients had fever for one day. 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.

Most of the vaccinations (101) were performed at an official vaccination center, 59 were performed at a general practitioner. No patients reported problems with the process of making an appointment or receiving the vaccination.

Conclusion

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.

This study is sponsored by Alnylam Pharmaceuticals, Cambridge, Massachusetts.