Fulminant myocarditis following SARS-CoV-2 mRNA vaccination rescued with venoarterial ECMO: A report of two cases.

INTRODUCTION: Cases of myocarditis after COVID-19 messenger RNA (mRNA) vaccines administration have been reported. Although the majority follow a mild course, fulminant presentations may occur. In these cases, cardiopulmonary support with venoarterial extracorporeal membrane oxygenation (V-A ECMO) may be needed. RESULTS: We present two cases supported with V-A ECMO for refractory cardiogenic shock due to myocarditis secondary to a mRNA SARS-CoV2 vaccine. One of the cases was admitted for out-of-hospital cardiac arrest. In both, a peripheral V-A ECMO was implanted in the cath lab using the Seldinger technique. An intra-aortic balloon pump was needed in one case for left ventricle unloading. Support could be successfully withdrawn in a mean of five days. No major bleeding or thrombosis complications occurred. Whereas an endomyocardial biopsy was performed in both, a definite microscopic diagnosis just could be reached in one of them. Treatment was the same, using 1000mg of methylprednisolone/day for three days. A cardiac magnetic resonance was performed ten days after admission, showing a significant improvement of the left ventricular ejection fraction and diffuse oedema and subepicardial contrast intake in different segments. Both cases were discharged fully recovered, with CPC 1. CONCLUSIONS: COVID-19 vaccine-associated fulminant myocarditis has a high morbidity and mortality but presents a high potential for recovery. V-A ECMO should be established in cases with refractory cardiogenic shock during the acute phase.

Development of a risk score for patients with ischaemic cardiomyopathy.

BACKGROUND: Ischaemic cardiomyopathy is a leading cause of heart failure and is associated with a poor prognosis. AIM: To evaluate predictors of major adverse cardiovascular events (MACE) and to develop a risk score for the disease. METHODS: All patients with ischaemic cardiomyopathy referred to a tertiary hospital between 2010 and 2018 for stress-rest gated single-photon emission computed tomography (SPECT) were included retrospectively (n=747). Clinical and gated SPECT-derived variables were analysed as predictors of MACE, a combined endpoint of cardiovascular mortality, heart failure hospitalization or myocardial infarction during follow-up. A multivariable Cox model using backwards stepwise regression with competing risks was used to select the best parsimonious model. RESULTS: After a median follow-up of 4.7 years, 313 patients had MACE (41.9%). Independent predictors of MACE were previous heart failure admission, worsening angina or dyspnoea, estimated glomerular filtration rate ≤60mL/min/1.73 m2, age>73 years, diabetes, atrial fibrillation, end-diastolic volume index>83mL/m2 and>12% of scarred myocardium. A risk score ranging from 0 to 12 classified patients as at intermediate risk (event rate of 4.0 MACE per 100 person-years), high risk (11.3 MACE per 100 person-years) or very high risk (27.8 MACE per 100 person-years). The internally validated area under the curve was 0.720 (95% confidence interval 0.660-0.740) and calibration was adequate (Hosmer-Lemeshow test P=0.28) for MACE. CONCLUSIONS: In patients with ischaemic cardiomyopathy, a simple risk score using dichotomic and readily available variables obtained from clinical assessment and gated SPECT accurately predicts the risk of MACE.

Usefulness of the Vall d'Hebron Risk Score to stratify the risk of patients with ischemic cardiomyopathy.

BACKGROUND: To evaluate the Vall d'Hebron-Risk-Score (VH-RS) to stratify the risk of patients with stable ischemic cardiomyopathy (ICM), and assess whether hemoglobin (Hb) and estimated glomerular filtration rate (eGFR) provide additional information to the VH-RS. METHODS AND RESULTS: We analysed 673 consecutive patients with ICM who underwent gated SPECT. According to VH-RS, we stratified patients into 4-risk-levels: very-low-risk (VLR), low-risk (LR), moderate-risk (MR), and high-risk (HRi). We considered as MACEs: non-fatal myocardial infarction (MI), heart failure hospitalization (HF), coronary revascularization (CR), and cardiac death (CD). Also the cardiac-resynchronization-therapy (CRT), and the implantable-cardioverter-defibrillator (ICD) were investigated. During the follow-up (4.8 ± 2.7 years), 379 patients had MACEs (0.18/patient/year). There were no patients in VLR and LR. All patients were reclassified in 3-risk-levels (MRi = 48; HRi = 121; VHRi[very high risk] = 504). Most patients with MACEs were in VHRi level (test-for-trend: MACEs ≥ 1 without CRT/ICD, P < .001; combined non-fatal MI, CD and CR, P < .001; MACEs ≥ 1 with CRT/ICD, P < .001). The Hb and eGFR values do not properly improve the risk stratification obtained by the VH-RS (global-NRI[net-reclassification-improvement] was: (MACEs ≥ 1 without CRT/ICD: - 10.6%; non-fatal MI, CD and CR: - 9.08%; and MACEs ≥ 1 with CRT/ICD: - 8.85%). CONCLUSION: VH-RS is effective in evaluating risk of patients with stable ICM. In our population, adding Hb and eGFR variables do not improve the performance of the VH-RS.

Sample size requirement in trials that use the composite endpoint major adverse cardiovascular events (MACE): new insights.

BACKGROUND: The real impact of the degree of association (DoA) between endpoint components of a composite endpoint (CE) on sample size requirement (SSR) has not been explored. We estimate the impact of the DoA between death and acute myocardial infarction (AMI) on SSR of trials using use the CE of major adverse cardiac events (MACE). METHODS: A systematic review and quantitative synthesis of trials that include MACE as the primary outcome through search strategies in MEDLINE and EMBASE electronic databases. We limited to articles published in journals indexed in the first quartile of the Cardiac & Cardiovascular Systems category (Journal Citation Reports, 2015-2020). The authors were contacted to estimate the DoA between death and AMI using joint probability and correlation. We analyzed the SSR variation using the DoA estimated from RCTs. RESULTS: Sixty-three of 134 publications that reported event rates and the therapy effect in all component endpoints were included in the quantitative synthesis. The most frequent combination was death, AMI, and revascularization (n = 20; 31.8%). The correlation between death and AMI, estimated from 5 trials¸ oscillated between - 0.02 and 0.31. SSR varied from 14,602 in the scenario with the strongest correlation to 12,259 in the scenario with the weakest correlation; the relative impact was 16%. CONCLUSIONS: The DoA between death and AMI is highly variable and may lead to a considerable SSR variation in a trial including MACE.

Impact of revascularization guided by functional testing in ischaemic cardiomyopathy.

AIMS: The burden of ischaemia is a risk factor for adverse outcomes in ischaemic cardiomyopathy (ICM) but is not systematically tested when deciding on revascularization. Limited data exists in patients with ICM regarding the interaction between ischaemia and early coronary revascularization (ECR). This study sought to determine if the burden of ischaemia modifies the outcomes of ECR in ICM. METHODS AND RESULTS: Consecutive patients with ICM (left ventricular ejection fraction < 40%) with a stress-rest gated single-photon emission computed tomography (N = 747) were followed-up for ECR and major cardiovascular events (MACEs, cardiovascular death, myocardial infarction, or heart failure hospitalization). A 1:1 matched population was selected using a propensity score for ECR. The interaction between ischaemia and ECR was evaluated in the matched cohort. In the initial cohort, 131 patients underwent ECR. Of them, 109 were matched to non-ECR patients. After a median follow up of 4.1 years, 102 (46.8%) patients experienced a MACE. The effect of revascularization on MACE was dependent of the percent of ischaemia (P for the interaction at 10% ischaemia = 0.021), so that a trend towards a decreased risk of MACE was seen in patients with >10% of ischaemia [hazard ratio (HR) = 0.59 (0.30-1.18)], whereas a non-significant increase of MACE was observed in those with <10% ischaemia (HR = 1.67 [0.94-2.96]). CONCLUSIONS: In a contemporary cohort of patients with ICM, the beneficial effects of ECR may be mediated by the percent of ischaemia. This study supports stress testing in ICM and an ischaemia-guided approach for ECR.

Echocardiographic assessment of COVID19 sequelae in survivors with elevated cardiac biomarkers.

AIMS: We sought to determine, using advanced echocardiography, the prevalence and type of cardiovascular sequelae after COVID19 infection with marked elevation of cardiovascular biomarkers (CVB), and their prognostic implications. METHODS: All patients admitted from March 1st to May 25th, 2020 to a tertiary referral hospital were included. Those with cardiovascular diseases or dead during admission were excluded. Patients with hs-TnI > 45 ng/L, NT-proBNP>300 pg/mL, and D-dimer >8000 ng/mL were matched with COVID controls (three biomarkers within the normal range) based on intensive care requirements and age, and separately analyzed. RESULTS: From 2025 patients, 80 patients with significantly elevated CVB and 29 controls were finally included. No differences in baseline characteristics were observed among groups, but elevated CVB patients were sicker. Follow-up echocardiograms showed no differences among groups regarding LVEF and only slight differences between groups within the normal range. Hs-TnI patients had lower myocardial work and longitudinal strain. The presence of an abnormal echocardiogram was more frequent in the elevated CVB group compared to controls (23.8 vs 10.3%, P = 0.123) but mainly associated with mild abnormalities in deformation parameters. Management did not change in any case and no major cardiovascular events except deep vein thrombosis occurred after a median follow-up of 7 months. CONCLUSION: Minimal abnormalities in cardiac structure and function are observed in COVID19 survivors without previous cardiovascular diseases who presented a significant CVB rise at admission, with no impact on patient management or short-term prognosis. These results do not support a routine screening program after discharge in this population.

Emergent Percutaneous Closure of a Free-Wall Perforation During Impella Implantation.

Free wall perforation during percutaneous manipulation of devices and wires into the ventricular cavities is an uncommon but life-threatening complication that should be managed with emergent surgery whenever possible. However, the number of patients with prohibitive surgical risk that undergo complex percutaneous cardiac procedures is increasing. Some cases of ventricle perforation during Impella® (Abiomed; Danvers, MA) implantation have been previously reported but in all previous reported cases the patient underwent emergent surgery. We present a case of iatrogenic perforation during Impella® implantation that was emergently treated using an Amplatzer® Duct Occluder II device (Abbott Vascular; Santa Clara, CA).

Q waves in ischemic cardiomyopathy.

Q waves may be observed in the absence of non-viable tissue. However, their scintigraphic translation in patients with ischemic cardiomyopathy (ICM) has not been properly assessed. This study sought to establish the determinants of Q waves in the absence of non-viable tissue and the diagnostic accuracy in this population. A retrospective study enrolling 487 consecutive patients (67.0 [57.4 - 75.4] years), with ICM, LVEF < 40% and narrow QRS who underwent stress-rest 99 m-Tc SPECT was conducted. A 17-segment model for myocardium was used: Myocardium was divided in basal (1 to 6), mid (7 to 12), apical (13 to 16) and apex (17) segments. Non-viable tissue was defined as a severe perfusion defect without systolic thickening. Patients with Q waves (65.7%) had more non-viable tissue, more extensive scar and less ischemia. Q waves had a moderate correlation with non-viable tissue (AUC = 0.63) and were associated with the extension of the scar. After excluding patients with non-viable tissue in any myocardial segment, Q waves were observed in 51.9% of the patients, of which 78.1% had a scar fulfilling viability criteria. The presence of Q waves was associated with the location of these scars in a base-to-apex axis (OR = 1.88 [1.35-2.62] for segment towards the apex) and their extent (OR = 1.19 [1.05 - 1.35] for each segment). In patients with ICM, Q waves discriminate poorly viable from non-viable tissue. Q waves in this population may be due to extensive scars fulfilling viability criteria located in apical segments.