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BACKGROUND: Device-related thrombus (DRT) following left atrial appendage occlusion (LAAO) can lead to adverse clinical outcomes. DRT rates and outcomes from randomized trials are limited.OBJECTIVES: This analysis investigated the incidence, predictors, and clinical outcomes of DRT following LAAO in the Amulet IDE (AMPLATZER Amulet LAA Occluder Trial) trial.METHODS: Successful implants occurred in 903 patients with an Amulet occluder (dual occlusive mechanism device) and 885 patients with a Watchman device (single occlusive mechanism device). These patients were then followed through 18 months and DRT was assessed by transesophageal echocardiography.RESULTS: The overall incidence of DRT was 3.9% (n = 70) with 3.4% (n = 30) in dual occlusive mechanism device patients and 4.8% (n = 40) in single occlusive mechanism device patients. Most DRTs (n = 19 of 31) were identified early (≤45 days) on the dual occlusive mechanism device, whereas most of the DRTs (n = 31 of 42) were identified late (>45 days) on the single occlusive mechanism device. Strong predictors of DRT included atrial fibrillation at time of procedure (HR: 2.44; 95% CI: 1.42-4.22; P < 0.01), female sex (HR: 1.65; 95% CI: 1.01-2.71; P = 0.04), and older age (HR: 1.04; 95% CI: 1.01-1.08; P = 0.02). There were no stroke events following DRT in the dual occlusive mechanism device group and 3 stroke events following DRT in the single occlusive mechanism device group. Patients with DRT were at a greater risk for cardiovascular mortality compared with non-DRT patients (8.7% vs 3.9%; HR: 2.33; 95% CI: 1.01-5.39; P = 0.04).CONCLUSIONS: Incidence of DRT following LAAO was low. Early DRTs are seen with the dual occlusive mechanism device and late DRTs are seen with the single occlusive mechanism device. Increased cardiovascular mortality risk in patients with DRT should be further investigated. (AMPLATZER Amulet LAA Occluder Trial; NCT02879448).

Echocardiography guidelines note that a flail leaflet is a specific criterion for severe mitral regurgitation (MR) and that regurgitant severity is underestimated in wall-impinging jets (Coandă effect). Both findings are often considered to be pathognomonic of severe MR.In this study, the authors sought to determine the association of flail leaflet and Coandă effect with MR severity quantified by means of cardiac magnetic resonance (CMR).The authors enrolled 158 consecutive patients with primary MR according to echocardiography and CMR. The presence of a flail leaflet or Coandă was determined for each patient. CMR regurgitant volume (RV) and regurgitant fraction (RF) were quantified for all patients.There were 55 patients (35%) with a flail leaflet, 52 (33%) with Coandă, and 22 (14%) with a flail leaflet and Coandă. The mean CMR mitral RV and RF progressively increased in patients without a Coandă or flail, a Coandă, a flail, or a Coandă and a flail (RV: 28 ± 21 mL vs 43 ± 23 mL vs 58 ± 29 mL vs 64 ± 25 mL [P 0.001]; RF: 25% ± 16% vs 34% ± 14% vs 41% ± 12% vs 45% ± 12% [P 0.001]). With the use of CMR RV, 35%, 46%, and 59% of patients had severe MR with the presence of a Coandă, flail leaflet, or both, respectively. With the use of CMR RF, 25%, 31%, and 40% of patients had severe MR with the presence of a Coandă, flail leaflet, or both, respectively.While the presence of a flail leaflet and Coandă effect on echocardiography are associated with higher regurgitant volumes and fractions, they are frequently not associated with severe MR as assessed by means of CMR. (Comparison Study of Echocardiography and Cardiovascular Magnetic Resonance Imaging in the Assessment of Mitral and Aortic Regurgitation; NCT04038879).

Severe symptomatic degenerative mitral regurgitation (DMR) has a poor prognosis in the absence of treatment, and new transcatheter options are emerging.The CLASP IID randomized trial (NCT03706833) is the first to evaluate the safety and effectiveness of the PASCAL system compared to the MitraClip system in patients with significant symptomatic DMR. In this report, we present the primary safety and effectiveness endpoints for the trial.Patients with 3+ or 4+ DMR at prohibitive surgical risk were assessed by a central screening committee and randomized 2:1 (PASCAL:MitraClip). Study oversight also included an echocardiographic core laboratory and a clinical events committee. The primary safety endpoint was a composite major adverse event (MAE) rate at 30 days. The primary effectiveness endpoint was the proportion of patients with MR ≤2+ at 6 months.A pre-specified interim analysis in 180 patients demonstrated non-inferiority of the PASCAL system vs. MitraClip system for the primary safety and effectiveness endpoints, MAE: 3.4% vs. 4.8%, MR ≤2+: 96.5% vs. 96.8%, respectively. Functional and quality-of-life outcomes significantly improved in both groups (p0.05). The proportion of patients with MR ≤1+ was durable in the PASCAL group from discharge to 6 months [PASCAL: 87.2% and 83.7% (p=0.317 vs. discharge); MitraClip: 88.5% and 71.2% (p=0.003 vs. discharge), respectively].The CLASP IID trial demonstrated safety and effectiveness of the PASCAL system and met non-inferiority endpoints, expanding transcatheter treatment options for prohibitive surgical risk patients with significant symptomatic DMR.

Transcatheter options for treating significant symptomatic mitral valve regurgitation (MR) have gained a significant role over the past decade in clinical practice. Increasing clinical trial eviden...

Graphical abstract, Highlights • Multimodality cardiac imaging can assess cardiac sarcomas and guide biopsy. • Cardiac MRI differentiates cardiac tumors from thrombus and identifies thrombus tumor. • Cardiac sarcoma treatment includes surgical and adjuvant options. • Survival rates of cardiac sarcoma are based on tumor location within the heart.

Objectives The study reports for the first time the 30-day outcomes of the first U.S. study with the Cardioband tricuspid valve reconstruction system for the treatment of functional tricus...

The purpose of this study was to compare the American Society of Echocardiography (ASE) algorithm for assessing mitral regurgitation (MR) to cardiac magnetic resonance (CMR) and left ventricular (LV) remodeling following mitral intervention.The ASE recommends integrating multiple echocardiographic parameters for assessing MR. The ASE guidelines include an algorithm that weighs the parameters and highlights those considered indicative of definitely mild or definitely severe MR.We prospectively enrolled 152 (age 62 ± 13 years; 59% male) patients with degenerative MR who underwent ASE algorithm-guided echocardiographic and CMR grading of MR severity. Using the ASE algorithm, patients were graded as definitely mild, grade I, grade II, grade III, grade IV, or definitely severe MR. CMR MR volume was graded as mild (30 mL), grade II moderate (30-44 mL), grade III moderate (45-59 mL), or severe (≥60 mL). A subgroup of 63 patients underwent successful mitral intervention, of whom 48 had postintervention CMR.Only 52% of patients with definitely severe MR by the ASE algorithm had severe MR by CMR, and 10% had mild MR by CMR. There was an increase in post mitral intervention LV reverse remodeling with worsening MR severity using CMR (P 0.0001) but not the ASE algorithm (P = 0.07). Severe MR by CMR was an independent predictor of post mitral intervention LV reverse remodeling and definitely severe MR by the ASE algorithm was not.In patients with degenerative MR, agreement between CMR and the ASE algorithm was suboptimal. Severe MR by CMR was an independent predictor of post mitral intervention LV reverse remodeling, whereas definitely severe MR by the ASE algorithm was not. These findings suggest an important role for CMR in surgical decision making in degenerative MR. (Comparison Study of Echocardiography and Cardiovascular Magnetic Resonance Imaging in the Assessment of Mitral and Aortic Regurgitation; NCT04038879).

OBJECTIVES We report the 30-day outcomes from the roll-in cohort of the CLASP IID trial, representing the first procedures performed by each site. BACKGROUND The currently enrolling CLASP IID/IIF pivotal trial is a multicenter, prospective, randomized trial assessing the safety and effectiveness of the PASCAL transcatheter valve repair system in patients with clinically significant MR. The trial allows for up to three roll-in patients per site. METHODS Eligibility criteria were: DMR ≥3+, prohibitive surgical risk, and deemed suitable for transcatheter repair by the local heart team. Trial oversight included a central screening committee and echocardiographic core laboratory. The primary safety endpoint was a 30-day composite MAE: cardiovascular mortality, stroke, myocardial infarction (MI), new need for renal replacement therapy, severe bleeding, and non-elective mitral valve re-intervention, adjudicated by an independent clinical events committee. Thirty-day echocardiographic, functional, and quality of life outcomes were assessed. RESULTS A total of 45 roll-in patients with mean age of 83 years and 69% in NYHA class III/IV were treated. Successful implantation was achieved in 100%. The 30-day composite MAE rate was 8.9% including one cardiovascular death (2.2%) due to severe bleeding from a hemorrhagic stroke, one MI, and no need for re-intervention. MR≤1+ was achieved in 73% and ≤2+ in 98% of patients. 89% of patients were in NYHA class I/II (p

Tricuspid regurgitation (TR) is a prevalent disease with limited treatment options.This is the first 30-day report of the U.S. single-arm, multicenter, prospective CLASP TR early feasibility study of the PASCAL transcatheter valve repair system in the treatment of TR.Patients with symptomatic TR despite optimal medical therapy, reviewed by the local heart team and central screening committee, were eligible for the study. Data were collected at baseline, discharge, and the 30-day follow-up and were reviewed by an independent clinical events committee and echocardiographic core laboratory. Feasibility endpoints included safety (composite major adverse event [MAE] rate), echocardiographic, clinical, and functional endpoints.Of the 34 patients enrolled in the study, the mean age was 76 years, 53% were women, the mean Society of Thoracic Surgeons score was 7.3%, 88% had atrial fibrillation/flutter, 97% had severe or greater TR, and 79% had New York Heart Association (NYHA) functional class III/IV symptoms. Twenty-nine patients (85%) received implants; at 30 days, 85% of them achieved a TR severity reduction of at least 1 grade, with 52% with moderate or less TR (p 0.001). The MAE rate was 5.9%, and none of the patients experienced cardiovascular mortality, stroke, myocardial infarction, renal complication, or reintervention. Eighty-nine percent of the patients improved to NYHA functional class I/II (p 0.001), the mean 6-min walk distance improved by 71 m (p 0.001), and the mean Kansas City Cardiomyopathy Questionnaire score improved by 15 points (p 0.001).In this early experience, the repair system performed as intended, with substantial TR reduction, favorable safety results with a low MAE rate, no mortality or reintervention, and significant improvements in functional status, exercise capacity, and quality of life. (Edwards CLASP TR EFS [CLASP TR EFS]; NCT03745313).

The study reports for the first time the 30-day outcomes of the first U.S. study with the Cardioband tricuspid valve reconstruction system for the treatment of functional tricuspid regurgitation (TR).Increasing severity of TR is associated with progressively higher morbidity and mortality; however, treatment options for isolated significant disease are limited.In this single-arm, multicenter, prospective Food and Drug Administration-approved early feasibility study (EFS), 30 patients with severe or greater symptomatic functional TR were enrolled who were deemed candidates for transcatheter tricuspid repair with the Cardioband tricuspid system by the local heart team and multidisciplinary screening committee.The mean patient age was 77 years, 80% were women, 97% had atrial fibrillation, 70% were in New York Heart Association functional class III to IV with mean left ventricular ejection fraction of 58%, and 27% had severe, 20% massive, and 53% torrential TR. Device success was 93% and all patients were alive at 30 days. Between baseline and 30 days, septolateral tricuspid annular diameter was reduced by 13% (p 0.001), 85% of patients had ≥1 grade TR reduction and 44% had ≤moderate TR, 75% were in New York Heart Association functional class I to II (p 0.001), and overall Kansas City Cardiomyopathy Questionnaire score improved by 16 points (p 0.001).In patients with severe symptomatic functional TR, this is the first study in the United States with the Cardioband tricuspid system for direct transcatheter annular reduction. This early feasibility study demonstrates high procedural feasibility with no 30-day mortality. There is significant reduction of functional TR with clinically significant improvements in functional status and quality of life. (Edwards Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study; NCT03382457).

Background: The American College of Cardiology/American Heart Association and American Society of Echocardiography guidelines recommend assessing several echocardiographic parameters when evaluating mitral regurgitation (MR) severity. These parameters can be discordant, making the assessment of MR challenging. The degree to which echocardiographic parameters of MR severity are concordant is not well studied. Methods: We enrolled 159 patients in a prospective multicenter study. Eight parameters were included in this analysis: proximal isovelocity surface area (PISA)–derived regurgitant volume, PISA-derived effective regurgitant orifice area, vena contracta, color Doppler jet/left atrial area, left atrial volume index, left ventricular end-diastolic volume index, peak E wave, and the presence of pulmonary vein systolic reversal. Each echocardiographic parameter was determined to represent severe or nonsevere MR according to the American Society of Echocardiography guidelines. A concordance score was calculated as so that a higher score reflects greater concordance. There was no discordance when all the echocardiographic parameters agreed and high discordance when 3 or 4 parameters were discordant. Results: The mean concordance score was 75±14% for the entire cohort. There were 9 (6%) patients with complete agreement of all parameters and 61 (38%) with high discordance. There was greater discordance in patients with severe MR but no difference between primary versus secondary or central versus eccentric jets. There was an improvement in concordance when only considering PISA-based regurgitant volume, PISA-based effective regurgitant orifice area, and vena contracta with agreement in 68% of patients. Conclusions: There was limited concordance between the echocardiographic parameters of MR severity, and the discordance was worse with more severe MR. Concordance improved when considering only 3 quantitative measures of vena contracta and PISA-based effective regurgitant orifice area and regurgitant volume. These findings highlight the challenges facing echocardiographers when assessing the severity of MR and emphasize the difficulty of using an integrated approach that incorporates multiple components. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04038879.

The aim of this study was to examine the initial experience with a novel transseptal transcatheter mitral valve replacement (TMVR) system.Transseptal TMVR may offer a less invasive option than surgery for mitral regurgitation (MR) with greater efficacy and fewer anatomic limitations than transcatheter repair.Patients were treated with the EVOQUE TMVR system from September 2018 to October 2019. Key inclusion criteria were moderate or greater MR, New York Heart Association functional class ≥II, and high or prohibitive surgical risk. The primary outcome was technical success, defined by Mitral Valve Academic Research Consortium criteria.Fourteen patients were treated, all with at least moderate to severe MR. The median age was 84 years, and the median Society of Thoracic Surgeons score was 4.6%. MR was degenerative in 4 (28.6%), functional in 3 (21.4%), and mixed in 7 (50%). Technical success was achieved in 13 patients (92.9%), and 1 patient was converted to surgery. At 30 days there was 1 noncardiovascular mortality (7.1%), 2 strokes (14.3%), no myocardial infarctions, and no rehospitalizations. Two patients (14.3%) underwent paravalvular leak closure. One patient (7.1%) underwent alcohol septal ablation for left ventricular outflow tract obstruction. Including the 2 patients with paravalvular leak closure, MR was mild or less in all implanted patients at 30 days, with no MR in 10 (83.3%). Mean mitral gradient was 5.8 mm Hg (median). New York Heart Association functional class improved to ≤II in 9 patients (81.8%).This first-in-human experience has demonstrated the feasibility of the transseptal EVOQUE TMVR system. Further clinical studies are required to establish safety and clinical outcomes.

Background The American Society of Echocardiography (ASE) guidelines suggest the use of several echocardiographic methods to assess mitral regurgitation severity using an integrated approach, without guidance as to the weighting of each parameter. The purpose of this multicenter prospective study was to evaluate the recommended echocardiographic parameters against a reference modality and develop and validate a weighting for each echocardiographic measure of mitral regurgitation severity. Methods This study included 112 patients who underwent evaluation with echocardiography and magnetic resonance imaging (MRI). Echocardiographic parameters recommended by the ASE were included and compared with MRI-derived regurgitant volume (MRI-RV). Results Echocardiographic parameters that correlated best with MRI-RV were proximal isovelocity surface area (PISA) radius (r = 0.65, P Conclusion Echocardiographic parameters of mitral regurgitation as recommended by the ASE had moderate correlations with MRI-RV. The best predictors of MRI-RV were PISA-derived effective regurgitant orifice area, PISA-derived regurgitant volume, left ventricular end-diastolic volume, and the presence of a flail leaflet, suggesting that these parameters should be weighted more heavily than other echocardiographic parameters in the application of the ASE-recommended integrated approach.

Previous reports have identified the role of transthoracic echocardiography (TTE) in detecting subclinical transcatheter heart valve (THV) thrombosis as limited to monitoring transvalvular gradients, because leaflet hypomobility or thrombus are usually seen only on transesophageal echocardiography (

This chapter discusses cardiac involvement and its echocardiographic features with a number of systemic diseases including sarcoidosis, carcinoid syndrome, hypereosinophilic syndromes, thyroid disorders, hemochromatosis, muscular dystrophies, lysosomal storage diseases, connective tissue diseases, obesity, hypertension, and diabetes mellitus. Marantic endocarditis, which can occur with a number of systemic diseases, is also discussed. Still and moving images of the echocardiographic features are provided.

Echocardiography is integral to the diagnosis and management of infective endocarditis (IE) because it can identify vegetations and complications associated with spreading infection, assess the severity of concomitant valve dysfunction, and document the impact of the disease on ventricular function and cardiovascular hemodynamics including pulmonary artery pressure. This chapter focuses on the role of echocardiography in IE with an emphasis on native and prosthetic valves. It discusses the imaging features of vegetations and complications of endocarditis including embolus, abscess, perforation, and other forms of valvular disruption and, in the case of prosthetic valves, variable degrees of dehiscence. It also covers the prognostic role of echocardiography, particularly in the prediction of embolic risk, and emphasizes the important role that echocardiography plays during follow-up treatment, and for intraprocedural guidance during surgical intervention.

The ASE recommends integrating multiple parameters for assessing mitral regurgitation (MR) severity by echo. The ASE guidelines include an algorithm that highlights criteria considered indicative of definitely mild or definitely severe MR. The purpose of this study was to compare this algorithm to

Objectives This study sought to assess the impact of systolic variation of mitral regurgitation (MR) has on discordance between echocardiography and magnetic resonance imaging (MRI). Background Studies have shown discordance between echocardiography and MRI when assessing the severity of MR. Contributing factors to this discordance may include the systolic variation of MR and the use of the color Doppler jet at a single point in time as the basis of many echocardiographic methods. Methods This analysis included 117 patients (62 ± 14 years of age; 58% male) with MR who underwent echocardiographic and MRI evaluation. Discordance was defined as the difference between the grades of MR (mild, moderate, or severe) by MRI and echocardiography. For each patient, 2 echocardiographic methods, the continuous wave time index and the color Doppler time index, and 1 MRI method, the systolic variation score (SVS), were measured to quantify systolic variation of MR. Results There was absolute agreement between echocardiography and MRI in 47 (40%) patients, a 1-grade difference in 54 (46%) patients, and a 2-grade difference in 16 (14%) patients. Only the SVS significantly differed between patients with and without discordance (0.60 ± 0.23 vs. 0.47 ± 0.21; p = 0.003). On receiver-operating characteristic analysis SVS had moderate predictive power of discordance (area under the curve: 0.67; p = 0.003), with an SVS of 53 having a sensitivity of 61% and a specificity of 65% to predict discordance. Conclusions Discordance between MRI and echocardiographic assessment of MR severity is associated with systolic variation of MR as quantified by MRI using the SVS. Continuous wave Doppler and the presence of color Doppler were not correlated with discordance. This study highlights an advantage of MRI. Namely, it does not rely on a single point in time to determine MR severity. Because systolic variation had only moderate sensitivity and specificity for predicting discordance, other factors are also responsible for the discordance between the 2 techniques.

Cardiac tamponade is caused by an abnormal increase in fluid accumulation in the pericardial sac, which, by raising intracardiac pressures, impedes normal cardiac filling and reduces cardiac output, sometimes dramatically so. This article outlines the pathophysiology, clinical features, and treatment of this important clinical condition highlighting the important role played by echocardiography in diagnosis and management.

Isolated reoperative tricuspid valve replacement is one of the highest risk operations classified in the Society of Thoracic Surgeons registry, particularly in the setting of preexisting right ventricular dysfunction. Transcatheter tricuspid valve-in-valve implantation represents an attractive alternative to redo surgery in patients with tricuspid bioprosthetic valve degeneration who are considered high-risk or unsuitable surgical candidates. In this review article, the authors discuss the emergence of transcatheter tricuspid valve-in-valve therapy, preprocedural echocardiographic assessment of tricuspid bioprosthetic valve dysfunction, periprocedural imaging required for tricuspid valve-in-valve implantation, and postprocedural assessment of tricuspid transcatheter device function.

Severe tricuspid regurgitation (TR) is associated with high morbidity and mortality rates with limited treatment options. We report the 30-day outcomes of the Cardioband Tricuspid Valve Reconstruction System in the treatment of moderate and severe functional TR in the first 15 patients enrolled in

Transcatheter valve implantation in the mitral position with severe calcific mitral stenosis has been described in patients who are at an increased risk for conventional mitral valve surgical procedures. We report the direct deployment of the Sapien 3 valve in the mitral position with severe mitral annular calcification through a sternotomy in an arrested heart in two cases.

An 84-year-old woman underwent successful transfemoral transcatheter aortic valve replacement (TAVR) using a 26-mm CoreValve Evolut R (Medtronic, Minneapolis, Minnesota). Intraoperative transesophageal echocardiography confirmed normal valve position and normal left ventricular function. Trace

Introduction: Guidelines suggest the use of several echocardiographic (Echo) parameters to assess mitral regurgitation (MR) severity using an integrated approach without guidance as how to weight each parameter. The aim of this study is to develop a hierarchy for Echo parameters of MR severity. Methods: This prospective study included 80 patients (63 ± 13 yrs, male 57%) with MR. Echo parameters including in this analysis were effective regurgitant orifice area (EROA), vena contracta (VC), LV EDD, color Doppler jet/LA area, the presence of a flail leaflet, and the presence of pulmonary vein wave systolic reversal. MR volume by MRI was calculated as the difference between the LV stroke volume and forward flow. A backward elimination multivariate linear regression analysis was used to determine which Echo parameters predicted regurgitant volume by MRI. Results: Individual Echo parameters that correlated best with MR volume by MRI were EROA (r = 0.68, p Conclusions: Echocardiographic parameters for assessing MR had only a moderate correlation with MR volume by MRI. The model that best predicted MR volume by MRI included EROA, VC, and the presence of a flail leaflet. EROA was the best at predicting MR volume by MRI, followed by VC and the presence of a flail leaflet. Not all of the recommended echocardiographic measures of MR severity were helpful in predicting MR volume by MRI. .

Background The assessment of mitral regurgitation (MR) severity is often based on echocardiographic criteria and clinical assessment. MRI can also quantify MR severity, indirectly as the difference between left ventricular (LV) stroke volume and forward flow. In clinical practice these imaging modalities can be discordant. The purpose of this prospective, multicenter trial is to compare the two techniques in assessing the severity of MR.

Introduction: The assessment of mitral regurgitation (MR) severity is often based on echocardiographic (Echo) criteria and clinical assessment. Recently MRI has been used to quantify MR. In clinical practice these imaging modalities can be discordant. In an ongoing multicenter prospective study, we evaluated the degree of discordance between Echo and MRI in patients with isolated MR. We also correlated the pre-surgical MR volume (MRVol) to the decrease in left ventricular end-diastolic volume (LV EDV) after successful mitral valve surgery (MVS). Hypothesis: Does the post-surgical change in LV EDV correlate with MRVol? Methods: The study included 96 pts (60 ± 14yrs, male 57%) with isolated MR (19 fxnl, 43 degen, 34 other). 31 pts had isolated MVS. Each pt had MRVol quantified using Echo (PISA method) and MRI (LV stroke volume - forward flow). MR severity was categorized as mild Results: MRI and Echo estimates of mitral RVol. were correlated (y=0.6x + 26) (r=0.6, p Conclusions: There is often discordance between Echo PISA and MRI when quantifying MRVol even in patients referred for surgery. To the degree that post-surgical LV remodeling reflects the reduction in LV volume overload achieved with successful MVS, these data suggest that MRVol quantified by MRI may be more accurate than MRVol quantified by Echo PISA.

Guidelines suggest that flail leaflet and Coanda are specific signs for severe mitral regurgitation. MRI is an accurate method for determining mitral regurgitant volume (RV) and regurgitant fraction (RF). The objective of this study is to determine the association of flail or Coanda with RV and RF