Acute myocarditis following Comirnaty vaccination in a healthy man with previous SARS-CoV-2 infection.

Myopericarditis following mRNA Covid-19 vaccination has recently been reported to health authorities in a lot of countries. They can occur in very rare cases after either the Moderna (mRNA-1273 - Spikevax) or Pfizer-BioNTech (BNT162b2 - Comirnaty) vaccination. Cases predominately occur in younger adult men within 14 days following the second dose. In this article, we present a 56 year-old man with no prior medical history, whit the exception of a mild Covid-19 infection 4 months earlier, who experienced an episode of acute epigastric pain, profuse sweating, tachycardia, hypotension 4 days after the first dose of BNT162b2 vaccine. Troponin I level was elevated. Chest X-ray, electrocardiogram, echocardiogram, coronary angiography didn't show significant abnormalities. Cardiac Magnetic Resonance showed a pattern of acute myocarditis. The condition appeared to be self-limited and the patient recovered without specific therapy. No report of acute myocarditis was observed in the BNT162b2 and mRNA-1273 trials and very rare cases, in comparison to given doses, have been reported to pharmacovigilance systems worldwide. Further surveillance and evaluation of this side effect are warranted to establish the correct balance of benefits and risks of Covid-19 mRNA vaccines, above all in children and younger people (categories with the higher reactogenicity and the lower risk of Covid-19 complications). At the present time the benefits of Covid-19 vaccination significantly exceed possible risks.

[Under-reporting of adverse drug reactions, a problem that also involves medicines subject to additional monitoring. Preliminary data from a single-center experience on novel oral anticoagulants]. / Mancata segnalazione di reazioni avverse ai farmaci: un problema che riguarda anche farmaci sottoposti a monitoraggio addizionale. Dati preliminari di un singolo centro sui nuovi anticoagulanti orali.

BACKGROUND: Spontaneous reporting system is the most widely used method by pharmacovigilance centers. Its "voluntary nature" represents the main cause of adverse drug reaction (ADR) under-reporting phenomena. The aim of this study was to point out the issue of ADR under-reporting from doctors, particularly serious ADRs and adverse reactions caused by medicinal products subject to additional monitoring, such as novel oral anticoagulants (NOACs). METHODS: Only serious ADRs were analyzed, defined as death, life-threatening ADR, hospitalization (initial or prolonged), disability (significant or permanent), congenital anomaly. Firstly, we analyzed suspected adverse reaction alerts to NOACs submitted to the Area Vasta 2 (ASUR Marche) pharmacovigilance center, from June 16, 2013 to January 14, 2017. Then, we examined alerts coming from all over Italy and from the Marche Region in the same time period. Secondly, the analysis was focused on the Senigallia hospital (where we had an easy access to the medical records archive); patients who experienced an ADR in that time period were identified retrospectively and an alert was submitted. Thirdly, from January 15, 2017 to March 15, 2017, suspected ADR alerts were submitted prospectively. RESULTS: Phase 1: in 43 months, 1625 alerts were submitted from all over Italy, 18 from the Marche Region (one of them from the Senigallia hospital). Phase 2: 8 suspected serious ADRs were collected retrospectively (2 fatal and 3 life-threatening). Phase 3: in only 2 months, 7 serious ADRs were observed prospectively (2 fatal and 1 life-threatening). CONCLUSIONS: Our study shows that among doctors the under-reporting phenomenon is remarkable and it also involves medicinal products subject to additional monitoring and serious ADRs, including deaths.

Clinical epidemiology in Italian Registry of Infective Endocarditis (RIEI): Focus on age, intravascular devices and enterococci.

INTRODUCTION: The epidemiology of infective endocarditis (IE) is changing due to a number of factors, including aging and health related comorbidities and medical procedures. The aim of this study is to describe the main clinical, epidemiologic and etiologic changes of IE from a large database in Italy. METHODS: We prospectively collected episodes of IE in 17 Italian centers from July 2007 to December 2010. RESULTS: We enrolled 677 patients with definite IE, of which 24% health-care associated. Patients were male (73%) with a median age of 62 years (IQR: 49-74) and 61% had several comorbidities. One hundred and twenty-eight (19%) patients had prosthetic left side IE, 391 (58%) native left side IE, 94 (14%) device-related IE and 54 (8%) right side IE. A predisposing cardiopathy was present in 50%, while odontoiatric and non odontoiatric procedures were reported in 5% and 21% of patients respectively. Symptoms were usually atypical and precocious. The prevalent etiology was represented by Staphylococcus aureus (27%) followed by coagulase-negative staphylococci (CNS, 21%), Streptococcus viridans (15%) and enterococci (14%). CNS and enterococci were relatively more frequent in patients with intravascular devices and prosthesis and S. viridans in left native valve. Diagnosis was made by transthoracic and transesophageal echocardiography in 62% and 94% of cases, respectively. The in-hospital mortality was 14% and 1-year mortality was 21%. CONCLUSION: The epidemiology is changing in Italy, where IE more often affects older patients with comorbidities and intravascular devices, with an acute onset and including a high frequency of enterococci. There were few preceding odontoiatric procedures.

Pulmonary tumor thrombotic microangiopathy: the challenge of the antemortem diagnosis.

Pulmonary tumor thrombotic microangiopathy (PTTM) is known as a rare and severe cancer-related pulmonary complication. Nowadays, fewer than 80 cases have been reported in the literature and very few cases have been diagnosed antemortem. We describe an autopsy case of PTTM associated with cancer of unknown origin. A 56-year-old male patient came to our attention due to a 2-day history of dyspnea. Analysis of the clinical context in combination with laboratory and imaging tests led us to suspect acute pulmonary thromboembolism. However, the computed tomography pulmonary angiogram was negative for thromboembolism; on the contrary it revealed multiple lymphadenopathy. Microscopic pulmonary tumor embolism was suspected and a lymph node biopsy was planned. However, the patient's condition progressively worsened; death occurred 3 days after admission. After autopsy, histologically extensive neoplastic emboli involved the small pulmonary arteries and arterioles, often admixed with fibrin thrombi. The involved and noninvolved arteries also demonstrated fibrocellular intimal proliferation causing marked luminal stenosis and occlusion. These pathological features were characteristic of PTTM, which should be distinguished from microscopic tumor embolism and should be considered in the differential diagnosis of acute/subacute cor pulmonale and pulmonary hypertension in cancer as well as in noncancer patients. We propose a review of the literature and an algorithm to improve PTTM antemortem diagnosis.

An elderly-centered, personalized, physiotherapy program early after cardiac surgery.

BACKGROUND: Early post-surgery in-hospital rehabilitation in elderly patients should be aimed at accelerating the recovery of the highest level of functional autonomy and reducing the hospital stay. DESIGN: We designed a personalized physiotherapy program tailored to the frailty level of over-70-year-old patients soon after cardiac surgery. The aims of this study were (a) to validate our frailty-based approach for functional stratification of the patients, and (b) to assess the effect of the individualized program on independence and mobility, and compare it with our usual program. METHODS: We followed 224 consecutive patients aged 70-87 years, who followed either the personalized (n= 150) or usual (n= 74) program. All patients underwent a comprehensive physical functioning evaluation at the baseline and at the end of hospitalization. RESULTS: The frailty-based stratification was successful in identifying those patients at higher risk of falls, with heavy nursing needs, greater dependency, and poorer heath status perception. On discharge, both groups had significantly improved on all measures of independence and mobility, but most of these changes (nursing needs, mobility, balance, and muscle strength) were significantly greater (P < 0.05) in the intervention group. These patients also had a significantly shorter length of stay (17.5 ± 8 vs. 21 ± 4 days, P = 0.0002), and 91% of them could be discharged in a state of substantial independence. CONCLUSION: An elderly-centered stratification based on functional frailty is useful to identify patients with more dependency and greater needs. A consequent personalized physiotherapy program designed to enhance independent mobility soon after cardiac surgery is safe and well accepted, and is more effective then usual physiotherapy.

[Myocardial and cerebral infarction as initial presentation of antiphospholipid syndrome]. / Infarto miocardico e cerebrale come presentazione iniziale di una sindrome da anticorpi antifosfolipidi.

The antiphospholipid antibody syndrome is the most common acquired thrombophilia; it is a systemic autoimmune disease characterized by recurrent arterial and venous thrombosis and/or pregnancy loss, in association with circulating antiphospholipid antibodies. The pathogenic mechanisms in antiphospholipid antibody syndrome that lead to in vivo injury are incompletely understood. Like other autoimmune diseases, a combination of genetic and environmental factors is involved. We report the case of a 50-year-old woman suffering from an antero-lateral non-ST-elevation myocardial infarction. After few days, coronary angiography showed a severe occlusive arterial disease, involving anterior descending, circumflex e right coronary arteries. Percutaneous coronary intervention was performed with the implantation of a drug-eluting stent in the proximal segment of the anterior descending coronary artery. One day after discharge (10 days after the first hospitalization) the patient experienced dizziness, nausea, vomiting, swelling in absence of any electrocardiographic abnormalities or myocardial enzyme elevation; then she was hospitalized in the neurology department. Because of a similar episode, urgent cerebral computed tomography scan was performed 5 days later; it revealed two different acute ischemic areas, parietal in the right hemisphere and cerebellar in the left hemisphere. The diagnosis of antiphospholipid antibody syndrome was confirmed by high anticardiolipin antibody titers, also present in medium titer at 5 and 17 weeks apart. She was discharged without any sequelae, on warfarin and double antiplatelet therapy (aspirin and clopidogrel for 6 months), then warfarin and aspirin.

Unusual association between "congenitally corrected transposition of the great arteries" and "noncompaction" of the right systemic ventricle.

Congenitally corrected transposition of the great arteries (CCTGA) is a rare and complex congenital anomaly characterized by atrial-ventricular (AV) discordance and ventricular-arterial discordance. Ventricular noncompaction (VNC) is a rare unclassified cardiomyopathy due to the arrest in intrauterine endomyocardial morphogenesis and it is characterized by numerous prominent trabeculations and intratrabecular recesses. We reported the case of a 47-year old female patient. When she was 35-year old an "isolated" CCTGA was diagnosed because of a heart murmur. Since then she attended periodically echocardiograms. She showed us 2 of them where right ventricle apical trabeculation was reported, without any others details. We performed a periodic evaluation in a patient still active, with a 6-month history of mild dyspnea occurring during exertion, no episodes of chest discomfort or palpitation. The ECG showed ectopic atrial rhythm, 83 bpm, normal QRS duration, QS complex in V1-V2 leads. The echocardiogram demonstrated: CCTGA, moderate enlargement and dysfunction of the right systemic ventricle, moderate to severe systemic AV valve regurgitation, severe thinning and dyskinesia of the basal segment of the septum, apical and mid-segments prominent and numerous trabeculations with deep intertrabecular recesses, better showed by color Doppler, in continuity with the ventricular cavity. This case presents some distinctive features: (1) the association between two rare congenital anomalies; (2) Striking right VNC, involving the apex and mid-segments, rarely described in literature; right VNC has been proposed according to the presence of 3 over 4 criteria proposed by Jenni et al. (Heart 86:666-671, 2001); (3) Severe thinning and dyskinesia of the basal segment of the septum, probably related to coronary artery abnormalities frequently described in CCTGA patients.

Echocardiography and cardiovascular magnetic resonance diagnostic role in Takotsubo cardiomyopathy.

We presented the case of a diabetic 67-year old female patient suffering from "Takotsubo cardiomyopathy". She arrived at the emergency department with severe chest pain soon after acute emotional and physical stress. The echocardiography performed in the acute phase showed balloon-like left ventricular wall motion abnormality with severe global dysfunction that showed complete normalization 4 days after the onset of symptoms. Cardiovascular magnetic resonance in the acute phase showed a small subendocardial hypo-perfusion area in the inferior wall (no longer present at the 3 week follow-up evaluation) and delayed hyperenhancement after administration of intravenous gadolinium in the same region that showed a significant reduction after 3 weeks.

[Elderly patient-centered rehabilitation after cardiac surgery]. / Percorso riabilitativo individualizzato dedicato al paziente ultrasettantenne cardioperato.

The rate of over-70 year post-surgery patients referred to the Cardiac Rehabilitation Units is increasing. Strategies designed to encourage and facilitate participation in rehabilitation programs in the elderly should be developed. Aim of this paper is to present our elderly-centered program, specifically designed on patient's needs and frailty, and its short- and medium-term results in 160 consecutive over-70 year patients, admitted in our Cardiac Rehabilitation Unit soon after cardiac surgery. The program was safe, well accepted by the patients, and effective in improving objective and subjective functional status.

Does atrial fibrillation in elderly patients with chronic heart failure limit the efficacy of carvedilol? Suggestions from an observational study.

BACKGROUND: No clinical investigation provided any information about a possible influence of atrial fibrillation on the response to beta-blocker therapy in elderly patients with chronic heart failure (CHF). The aim of this study was to observe carvedilol effects in a cohort of patients > 70 years of age with CHF due to left ventricular dysfunction and with chronic atrial fibrillation. METHODS: An observational, 12-month prospective clinical and echocardiographic study was carried out on 240 patients > 70 years of age with heart failure due to systolic dysfunction, 64 of whom with atrial fibrillation. RESULTS: After 1 year of beta-blocker treatment, patients with atrial fibrillation and those in sinus rhythm showed similar benefits, in terms of symptomatic improvement (deltaNYHA -0.44 if atrial fibrillation vs -0.57 if sinus rhythm, p = NS), reduction of events (death + hospitalizations -38 vs -15%), recovery of cardiac function (left ventricular ejection fraction delta +8.8 vs +9.4%, p = NS; left ventricular end-diastolic volume delta -17.2 vs -12.5 ml, p = NS), and reduction in mitral regurgitation (delta -042 vs -0.57, p = NS). No difference was found between the two study groups regarding left ventricular end-diastolic volume reduction (12% in atrial fibrillation patients and 18% in sinus rhythm patients, p = NS) and prevalence of the "reverse remodeling" phenomenon (22 and 21%, respectively, p = NS). CONCLUSIONS: In CHF patients > 70 years of age, beta-adrenergic blockade was shown to be equally effective in improving symptoms and left ventricular geometry and function in patients with atrial fibrillation or in sinus rhythm, without any adjunctive sign of long-term clinical deterioration.