Clinical Comparison of a Novel Balloon-Expandable Versus a Self-Expanding Transcatheter Heart Valve for the Treatment of Patients with Severe Aortic Valve Stenosis: The EVAL Registry

Background: Transcatheter aortic valve replacement (TAVR) is an effective treatment option for patients with severe, symptomatic AS, regardless of the transcatheter heart valve (THV) implanted. Prior studies demonstrated a higher device success with lower paravalvular leak (PVL) using the balloon-expandable (BE) Sapien/XT THV vs. a self-expanding (SE) THV. However, few data are available on the performance of a novel BE THV. Purpose: to compare early clinical performance and safety of the newly available BE Myval THV (Myval, Meril Life Sciences Pvt. Ltd., India) vs. the commonly used SE (Evolut R, Medtronic) THV. Methods: A single-center, retrospective cohort analysis was performed with 166 consecutive patients undergoing TAVR from March 2019 to March 2021 for severe symptomatic AS treated with either the novel BE Myval or the SE Evolut R (ER) bioprosthesis. The primary endpoint was device success at day 30 according to the Valve Academic Research Consortium-3 (VARC-3). Secondary endpoints included 30-day all-cause mortality, cardiovascular mortality, more than mild PVL, permanent pacemaker implantation (PPI) rates and a composite of all-cause mortality and disabling stroke at 6 months. Results: Among the 166 included patients, 108 patients received the SE ER THV and 58 patients were treated with the BE Myval THV. At baseline, the two groups showed comparable demographic characteristics. The primary composite endpoint of early device success occurred in 55 patients (94.8%) in the BE Myval group and in 90 patients (83.3%) in the SE ER group (OR 3.667, 95% CI 1.094–12.14; p = 0.048). At day 30, the BE Myval THV group exhibited a significantly lower incidence of more than mild PVL (BE Myval 3.45% vs. SE ER 14.8%, OR 0.2, 95% CI 0.05–0.8; p = 0.0338), along with a lower rate of PPI (BE Myval 11% vs. SE ER 24.2%, OR 0.38, 95% CI 0.15–0.99; p = 0.0535). At the 6-month follow-up, the incidence of all-cause mortality and disabling stroke did not significantly differ between the two groups, while the incidence of PPI (BE Myval 11% vs. SE ER 27.5%, OR 0.32, CI 95% 0.1273–0.8; p = 0.02) and ≥moderate PVL (BE Myval 6.9% vs. SE ER 19.8%, OR 0.31, 95% CI 0.1–0.94; p = 0.0396) was significantly lower in the BE Myval group. Conclusions: In patients with severe symptomatic AS undergoing TAVR, the novel Myval BE THV provided a comparable performance to the well-known ER SE THV, and it was associated with a lower rate of PPI and ≥moderate PVL within 30 days and 6 months after the procedure. Randomized, head-to-head comparison trials are needed to confirm our results

Clinical Presentation and Outcome in a Contemporary Cohort of Patients with Acute Myocarditis: The Multicenter Lombardy Registry

Background -There is controversy regarding outcome of patients with acute myocarditis (AM), and lack of data on how patients admitted with suspected AM are managed. We report characteristics, in-hospital management and long-term outcome of patients with AM based on a retrospective multi-center registry from 19 Italian hospitals. Methods -A total of 684 patients with suspected AM and recent onset of symptoms (70 years and those older than 50 years without coronary angiography were excluded. The final study population comprised 443 patients (median age 34 years, 19.4% female) with AM diagnosed either by endomyocardial biopsy (EMB) or increased troponin plus edema and late gadolinium enhancement at cardiac magnetic resonance (CMR). Results -At presentation, 118 patients (26.6%) had either left ventricular (LV) ejection fraction (EF) <50%, sustained ventricular arrhythmias (VA) or a low cardiac output syndrome (LCOS) whilst 325 (73.4%) had no such complications. EMB was performed in 56/443 (12.6%), and a baseline CMR was performed in 415/443 (93.7%) of patients. Cardiac mortality plus heart transplant (HTx) at 1 and 5 years were 3.0% and 4.1%. Cardiac mortality plus HTx were 11.3% and 14.7% in patients with complicated presentation and 0% in uncomplicated cases (Log-rank p<0.0001). Major AM-related cardiac events after the acute phase (post-discharge death and HTx, sustained VA treated with electrical shock or ablation, symptomatic heart failure needing device implantation) occurred in 2.8% at 5-year follow up, with a higher incidence in patients with complicated forms (10.8% vs. 0% in uncomplicated AM, Log-rank p<0.0001). Beta adrenoceptor blockers were the most frequently employed medications both in complicated (61.9%) and in uncomplicated forms (53.8%, p=0.18). After a median time of 196 days, 200 patients had follow-up CMR and 8/55 (14.5%) with complications at presentation had LVEF<50% compared with 1/145 (0.7%) of those with uncomplicated presentation. Conclusions -In this contemporary study, overall serious adverse events after AM were lower than previously reported. However, patients with LVEF<50%, VA or LCOS at presentation were at higher risk compared with uncomplicated cases that had a benign prognosis and low risk of subsequent LV systolic dysfunction

Prevalence, Characteristics, and Outcomes of COVID-19-Associated Acute Myocarditis

Background: Acute myocarditis (AM) is thought to be a rare cardiovascular complication of COVID-19, although minimal data are available beyond case reports. We aim to report the prevalence, baseline characteristics, in-hospital management, and outcomes for patients with COVID-19-associated AM on the basis of a retrospective cohort from 23 hospitals in the United States and Europe. Methods: A total of 112 patients with suspected AM from 56 963 hospitalized patients with COVID-19 were evaluated between February 1, 2020, and April 30, 2021. Inclusion criteria were hospitalization for COVID-19 and a diagnosis of AM on the basis of endomyocardial biopsy or increased troponin level plus typical signs of AM on cardiac magnetic resonance imaging. We identified 97 patients with possible AM, and among them, 54 patients with definite/probable AM supported by endomyocardial biopsy in 17 (31.5%) patients or magnetic resonance imaging in 50 (92.6%). We analyzed patient characteristics, treatments, and outcomes among all COVID-19-associated AM. Results: AM prevalence among hospitalized patients with COVID-19 was 2.4 per 1000 hospitalizations considering definite/probable and 4.1 per 1000 considering also possible AM. The median age of definite/probable cases was 38 years, and 38.9% were female. On admission, chest pain and dyspnea were the most frequent symptoms (55.5% and 53.7%, respectively). Thirty-one cases (57.4%) occurred in the absence of COVID-19-associated pneumonia. Twenty-one (38.9%) had a fulminant presentation requiring inotropic support or temporary mechanical circulatory support. The composite of in-hospital mortality or temporary mechanical circulatory support occurred in 20.4%. At 120 days, estimated mortality was 6.6%, 15.1% in patients with associated pneumonia versus 0% in patients without pneumonia (P=0.044). During hospitalization, left ventricular ejection fraction, assessed by echocardiography, improved from a median of 40% on admission to 55% at discharge (n=47; P&lt;0.0001) similarly in patients with or without pneumonia. Corticosteroids were frequently administered (55.5%). Conclusions: AM occurrence is estimated between 2.4 and 4.1 out of 1000 patients hospitalized for COVID-19. The majority of AM occurs in the absence of pneumonia and is often complicated by hemodynamic instability. AM is a rare complication in patients hospitalized for COVID-19, with an outcome that differs on the basis of the presence of concomitant pneumonia