Etiologies and Impact of Exclusion Rates for Transcatheter Mitral and Tricuspid Valve Structural Heart Clinical Trials at a High-Volume Quaternary Care Hospital.

There are various devices under clinical investigation for transcatheter mitral valve intervention and transcatheter tricuspid valve intervention (TTVI); however, the exclusion rates remain high. We aimed to investigate the exclusion rates for transcatheter mitral valve repair (TMVr), transcatheter mitral valve replacement (TMVR), transcatheter tricuspid valve repair (TTVr), and transcatheter tricuspid valve replacement (TTVR). There were 129 patients who were referred to St. Francis Hospital & Heart Center valve clinic and completed screening between January 2021 and July 2022. The causes for exclusion were classified into 4 categories: patient withdrawal, anatomic unsuitability, clinical criteria, and medical futility. In 129 patients, the exclusion rates for TMVr, TMVR, TTVr, and TTVR were 81%, 85%, 91%, and 87%, respectively. Patient withdrawal and medical futility were leading etiologies for exclusion, followed by anatomic unsuitability. TMVr had the highest rate of patient withdrawal (64%) and the lowest anatomic unsuitability (5%) because of short posterior leaflet length. Replacement interventions have a higher anatomic unsuitability (33%) than repair interventions (17%) (p = 0.04). Most exclusions of anatomic unsuitability were because of mitral stenosis or small annulus size for TMVR and large annulus size for TTVR. A total of 50% of exclusions from TTVr were because of the presence of pacemaker/defibrillator leads. In patients excluded from their respective trials, patients being referred for TMVr had the highest recurrent hospitalization and repair group had a higher mortality (p <0.01 and p = 0.01, respectively). In conclusion, the exclusion rates for transcatheter mitral valve intervention and TTVI trials remain high because of various reasons, limiting patient enrollment and treatment. This supports the need for further device improvement or exploring alternative means of therapy.

Reduced cardiac function is associated with cardiac injury and mortality risk in hospitalized COVID-19 Patients.

BACKGROUND: Cardiac injury is common in COVID-19 patients and is associated with increased mortality. However, it remains unclear if reduced cardiac function is associated with cardiac injury, and additionally if mortality risk is increased among those with reduced cardiac function in COVID-19 patients. HYPOTHESIS: The aim of this study was to assess cardiac function among COVID-19 patients with and without biomarkers of cardiac injury and to determine the mortality risk associated with reduced cardiac function. METHODS/RESULTS: This retrospective cohort study analyzed 143 consecutive COVID-19 patients who had an echocardiogram during hospitalization between March 1, 2020 and May 5, 2020. The mean age was 67 ± 16 years. Cardiac troponin-I was available in 131 patients and an increased value (>0.03 ng/dL) was found in 59 patients (45%). Reduced cardiac function, which included reduced left or right ventricular systolic function, was found in 40 patients (28%). Reduced cardiac function was found in 18% of patients without troponin-I elevation, 42% with mild troponin increase (0.04-5.00 ng/dL) and 67% with significant troponin increase (>5 ng/dL). Reduced cardiac function was also present in more than half of the patients on mechanical ventilation or those deceased. The in-hospital mortality of this cohort was 28% (N = 40). Using logistic regression analysis, we found that reduced cardiac function was associated with increased mortality with adjusted odds ratio (95% confidence interval) of 2.65 (1.18 to 5.96). CONCLUSIONS: Reduced cardiac function is highly prevalent among hospitalized COVID-19 patients with biomarkers of myocardial injury and is independently associated with mortality.

Relative importance of errors in left ventricular quantitation by two-dimensional echocardiography: insights from three-dimensional echocardiography and cardiac magnetic resonance imaging.

BACKGROUND: The accuracy of left ventricular (LV) volumes and ejection fraction (EF) on two-dimensional echocardiography (2DE) is limited by image position (IP), geometric assumption (GA), and boundary tracing (BT) errors. METHODS: Real-time three-dimensional echocardiography (RT3DE) and cardiac magnetic resonance imaging (CMR) were used to determine the relative contribution of each error source in normal controls (n = 35) and patients with myocardial infarctions (MIs) (n = 34). LV volumes and EFs were calculated using (1) apical biplane disk summation on 2DE (IP + GA + BT errors), (2) biplane disk summation on RT3DE (GA + BT errors), (3) 4-multiplane to 8-multiplane surface approximation on RT3DE (GA + BT errors), (4) voxel-based surface approximation on RT3DE (BT error alone) and (5) CMR. By comparing each method with CMR, the absolute and relative contributions of each error source were determined. RESULTS: IP error predominated in LV volume quantification on 2DE in normal controls, whereas GA error predominated in patients with MIs. Underestimation of volumes on 2DE was overcome by increasing the number of imaging planes on RT3DE. Although 4 equidistant image planes were acceptable, the best results were achieved with voxel-based RT3DE. For EF estimation, IP error predominated in normal controls, whereas BT error predominated in patients with MIs. Nevertheless, one third of the EF estimation error in patients with MIs was due to a combination of IP and GA errors, both of which may be addressed using RT3DE. CONCLUSIONS: The relative contribution of each source of LV quantitation error on 2DE was defined and quantified. Each source of error differed depending on patient characteristics and LV geometry.

Mitral annular remodeling with varying degrees and mechanisms of chronic mitral regurgitation.

HYPOTHESES: Degree of mitral annular remodeling is directly associated with severity of chronic mitral regurgitation (MR). Mitral annular remodeling occurs in a symmetric fashion, regardless of MR severity. In addition to MR severity, MR mechanism plays a significant role in mitral annular remodeling. BACKGROUND: Limited data exists on mitral annular remodeling in patients with MR. Identification of annular changes may be important in aiding surgical repair. METHODS: Mitral annular dimensions (anteroposterior, intercommissural, surface area, and circumference) were measured in end systole and diastole using 3-dimensional reconstructive software in 83 patients: trace to no MR (23), mild MR (15), moderate MR (26), and severe MR (19). Annular sphericity indices were determined by dividing intercommissural by anteroposterior dimensions. Patients were further subgrouped by mechanism of MR. RESULTS: With increasing MR severity, there was a corresponding increase in all annular measurements, most pronounced in the anteroposterior dimension, circumference, and area. Larger increases were seen in patients with prolapse/flail and dilated mechanisms. Furthermore, the mitral annulus became more circular (sphericity index approached 1.0) with increasing MR severity. Patients with prolapse/flail mechanisms exhibited normal left ventricular volumes despite significant annular enlargement. CONCLUSIONS: Mitral annular remodeling is directly associated with MR severity and occurs in an asymmetric fashion, yet is not limited to one region of the annulus. Mechanism of MR plays a significant role in annular remodeling. Annular remodeling can occur independently of left ventricular remodeling.

Intraoperative assessment of mitral regurgitation: role of phenylephrine challenge.

OBJECTIVES: We defined the effects of the operative (OP) state and phenylephrine challenge on the assessment of mitral regurgitation (MR) severity. METHODS: In all, 57 patients underwent transesophageal echocardiographic assessment of MR severity pre-OP (PREOP) and intra-OP. MR severity was assessed PREOP under conscious sedation and intra-OP with general anesthesia, before and after hemodynamic manipulation with vasoactive agents, to match intra-OP and PREOP transesophageal echocardiographic mean arterial blood pressures. RESULTS: Intra-OP MR and mean arterial pressure were less than PREOP in 27 patients (both P < .001). When PREOP and OP blood pressures were matched using phenylephrine, there was no significant difference in MR severity between the two states (P = 1.0). Nonetheless, MR severity was still underestimated in 6 patients and overestimated in 7 patients intra-OP. CONCLUSIONS: Intra-OP transesophageal echocardiography underestimates MR severity. Phenylephrine reduces, yet does not eliminate, intra-OP underestimation of MR severity.

Relationship of mitral annular remodeling to severity of chronic mitral regurgitation.

HYPOTHESES: (1) Mitral regurgitation (MR) severity is directly associated with mitral annular remodeling as evidenced by mitral annular enlargement. (2) Increasing severity of chronic MR will result in symmetric enlargement of the mitral annulus as measured by annular shape indices. BACKGROUND: Limited data exist on mitral annular remodeling for patients with MR. Identification of annular changes may be important in aiding surgical repair. METHODS: The mitral annulus was measured in several planes using transthoracic echocardiography in 173 patients: trace to no MR (34), mild MR (48), moderate MR (45), and severe MR (46). Patients were subgrouped by mechanism of MR and annular shape indices were determined. RESULTS: With increasing MR severity, there was a corresponding symmetric increase in all systolic and diastolic measurements, but no significant differences in annular shape indices between subgroups by MR severity or by MR mechanism. CONCLUSIONS: Mitral annular remodeling is symmetric, regardless of degree or mechanism of MR.