Structural Heart Imaging Using 3-Dimensional Intracardiac Echocardiography: JACC Cardiovascular Imaging Position Statement.

3-dimensional (3D) intracardiac echocardiography (ICE) is emerging as a promising complement and potential alternative to transesophageal echocardiography for imaging guidance in structural heart interventions. To establish standardized practices, our multidisciplinary expert position statement serves as a comprehensive guide for the appropriate indications and utilization of 3D-ICE in various structural heart procedures. The paper covers essential aspects such as the fundamentals of 3D-ICE imaging, basic views, and workflow recommendations specifically tailored for ICE-guided structural heart procedures, such as transeptal puncture, device closure of intracardiac structures, and transcatheter mitral and tricuspid valve interventions. Current challenges, future directions, and training requirements to ensure operator proficiency are also discussed, thereby promoting the safety and efficacy of this innovative imaging modality to support expanding its future clinical applications.

Safety of Same-Day Hospital Discharge Post Patent Foramen Ovale Closure: Findings from a Multicenter Study.

Transcatheter patent foramen ovale (PFO) closure is indicated for patients with cryptogenic stroke. Although procedural safety is well established, there are limited data on the safety of same-day (SD) discharge. We aimed to review the outcomes of PFO closure with SD. Patients who underwent transcatheter PFO closure between January 2011 and May 2022 at 4 large US hospitals were retrospectively analyzed, comparing outcomes of SD versus delayed discharge (DD). The primary end point was a composite of access-site complication, stroke, device embolization, atrial arrhythmia, and bleeding. Secondary analysis comparing imaging modality and outcomes was performed. 554 patients (49.2% female) were analyzed (382 discharged SD). Average age was 54.3 ± 15. Baseline characteristics in both groups were broadly similar. Previous stroke (78.0% SD vs 76.2% DD, p = 0.32) was the commonest indication for PFO closure. In the SD group, there was less general anesthesia use (5.5% vs 16.9%, p <0.001). Intraprocedural intracardiac echocardiography was used more frequently in SD cases (95.0% vs 81.4%, p <0.001). In the DD group, median stay was 1 night, and 34.9% stayed beyond 1 night. At 30 days, there was no difference in the primary composite end point (14.9% vs 11.6%, p = 0.15). There was no inter-group difference in individual adverse events (all p >0.05). When comparing imaging modality and outcomes, there was no difference in composite end points between transesophageal and intracardiac echocardiography (6.5% vs 14.7%, p = 0.063). In conclusion, SD discharge after transcatheter PFO closure appears safe. This efficient approach may be advantageous in optimizing workflow and minimizing hospital occupancy.

Treatment of left main coronary artery compression in the setting of unpalliated congenital heart disease: a case series.

Background: Left main coronary artery compression syndrome (LMCS) is a well-characterized phenomenon resulting from compression of the left main coronary artery (LMCA) between the aorta and an enlarged pulmonary arterial trunk. The development of LMCS is usually described in the context of severe pulmonary arterial hypertension. Cases of LMCS, in the context of unpalliated congenital heart disease (CHD), are complex clinical scenarios that challenge traditional treatment paradigms. Case summary: Here, we discuss two thought-provoking patients with unpalliated CHD complicated by severe pulmonary hypertension (PH). Both patients developed LMCS, one with severe non-ST elevation myocardial infarction and the other with refractory angina. Their pulmonary vascular resistance was severely elevated despite pulmonary vasodilator therapy, and concomitant surgical correction of their CHD in addition to bypass grafting was deemed high risk. They underwent successful percutaneous coronary intervention (PCI) of the LMCA with drug-eluting stents. Discussion: Pulmonary hypertension can develop in the setting of long-standing unpalliated CHD. Surgical correction of congenital heart defects may be performed in select patients with systemic-to-pulmonary shunts, contingent on the status of PH severity. Pulmonary vasodilator therapy modulates haemodynamics to ensure surgical correction without risk of cardiopulmonary demise-termed the 'treat and repair' strategy. LMCS, an increasingly recognized phenomenon in patients with long-standing PH, is a notable complicating factor in the 'treat and repair' strategy. We introduce the concept that PCI of the LMCA may bridge patients to corrective surgery for CHD by allowing time for optimization of their pulmonary vasodilator therapy.

Looking towards the future: patient-specific computational modeling to optimize outcomes for transcatheter mitral valve repair.

Severe mitral valve regurgitation (MR) is a heart valve disease that progresses to end-stage congestive heart failure and death if left untreated. Surgical repair or replacement of the mitral valve (MV) remains the gold standard for treatment of severe MR, with repair techniques aiming to restore the native geometry of the MV. However, patients with extensive co-morbidities may be ineligible for surgical intervention. With the emergence of transcatheter MV repair (TMVR) treatment paradigms for MR will evolve. The longer-term outcomes of TMVR and its effectiveness compared to surgical repair remain unknown given the differing patient eligibility for either treatment at this time. Advances in computational modeling will elucidate answers to these questions, employing techniques such as finite element method and fluid structure interactions. Use of clinical imaging will permit patient-specific MV models to be created with high accuracy and replicate MV pathophysiology. It is anticipated that TMVR technology will gradually expand to treat lower-risk patient groups, thus pre-procedural computational modeling will play a crucial role guiding clinicians towards the optimal intervention. Additionally, concerted efforts to create MV models will establish atlases of pathologies and biomechanics profiles which could delineate which patient populations would best benefit from specific surgical vs. TMVR options. In this review, we describe recent literature on MV computational modeling, its relevance to MV repair techniques, and future directions for translational application of computational modeling for treatment of MR.

Association of Body Mass Index With Clinical Features and Outcomes in Adults With Fontan Palliation.

Background With improving survival of patients with single ventricle physiology who underwent Fontan palliation, there is also an increase in the prevalence of overweight and obesity in these patients. This tertiary care single-center study aims to determine the association of body mass index (BMI) with the clinical characteristics and outcomes in adults with Fontan. Methods and Results Adult patients (aged ≥18 years) with Fontan who were managed at a single tertiary care center between January 1, 2000, and July 1, 2019, and had BMI data available were identified via retrospective review of medical records. Univariate and multivariable (after adjusting for age, sex, functional class, and type of Fontan) linear and logistic regression, as appropriate, were utilized to evaluate associations between BMI and diagnostic testing and clinical outcomes. A total of 163 adult patients with Fontan were included (mean age, 29.9±9.08 years), with a mean BMI of 24.2±5.21 kg/m2 (37.4% of patients had BMI ≥25 kg/m2). Echocardiography data were available for 95.7% of patients, exercise testing for 39.3% of patients, and catheterization for 53.7% of patients. Each SD increase in BMI was significantly associated with decreased peak oxygen consumption (P=0.010) on univariate analysis and with increased Fontan pressure (P=0.035) and pulmonary capillary wedge pressure (P=0.037) on multivariable analysis. In addition, BMI ≥25 kg/m2 was independently associated with heart failure hospitalization (adjusted odds ratio [AOR], 10.2; 95% CI, 2.79-37.1 [P<0.001]) and thromboembolic complications (AOR, 2.79; 95% CI, 1.11-6.97 [P=0.029]). Conclusions Elevated BMI is associated with poor hemodynamics and worse clinical outcomes in adult patients with Fontan. Whether elevated BMI is the cause or consequence of poor clinical outcomes needs to be further established.

Machine learning used for simulation of MitraClip intervention: A proof-of-concept study.

Introduction: Severe mitral regurgitation (MR) is a mitral valve disease that can lead to lifethreatening complications. MitraClip (MC) therapy is a percutaneous solution for patients who cannot tolerate surgical solutions. In MC therapy, a clip is implanted in the heart to reduce MR. To achieve optimal MC therapy, the cardiologist needs to foresee the outcomes of different scenarios for MC implantation, including the location of the MC. Although finite element (FE) modeling can simulate the outcomes of different MC scenarios, it is not suitable for clinical usage because it requires several hours to complete. Methods: In this paper, we used machine learning (ML) to predict the outcomes of MC therapy in less than 1 s. Two ML algorithms were used: XGBoost, which is a decision tree model, and a feed-forward deep learning (DL) model. The MC location, the geometrical attributes of the models and baseline stress and MR were the features of the ML models, and the predictions were performed for MR and maximum von Mises stress in the leaflets. The parameters of the ML models were determined to achieve the minimum errors obtained by applying the ML models on the validation set. Results: The results for the test set (not used during training) showed relative agreement between ML predictions and ground truth FE predictions. The accuracy of the XGBoost models were better than DL models. Mean absolute percentage error (MAPE) for the XGBoost predictions were 0.115 and 0.231, and the MAPE for DL predictions were 0.154 and 0.310, for MR and stress, respectively. Discussion: The ML models reduced the FE runtime from 6 hours (on average) to less than 1 s. The accuracy of ML models can be increased by increasing the dataset size. The results of this study have important implications for improving the outcomes of MC therapy by providing information about the outcomes of MC implantation in real-time.

Rationale, design and methodology of APPROACH-IS II: International study of patient-reported outcomes and frailty phenotyping in adults with congenital heart disease.

BACKGROUND: In recent years, patient-reported outcomes (PROs) have received increasing prominence in cardiovascular research and clinical care. An understanding of the variability and global experience of PROs in adults with congenital heart disease (CHD), however, is still lacking. Moreover, information on epidemiological characteristics and the frailty phenotype of older adults with CHD is minimal. The APPROACH-IS II study was established to address these knowledge gaps. This paper presents the design and methodology of APPROACH-IS II. METHODS/DESIGN: APPROACH-IS II is a cross-sectional global multicentric study that includes Part 1 (assessing PROs) and Part 2 (investigating the frailty phenotype of older adults). With 53 participating centers, located in 32 countries across six continents, the aim is to enroll 8000 patients with CHD. In Part 1, self-report surveys are used to collect data on PROs (e.g., quality of life, perceived health, depressive symptoms, autonomy support), and explanatory variables (e.g., social support, stigma, illness identity, empowerment). In Part 2, the cognitive functioning and frailty phenotype of older adults are measured using validated assessments. DISCUSSION: APPROACH-IS II will generate a rich dataset representing the international experience of individuals in adult CHD care. The results of this project will provide a global view of PROs and the frailty phenotype of adults with CHD and will thereby address important knowledge gaps. Undoubtedly, the project will contribute to the overarching aim of improving optimal living and care provision for adults with CHD.

Valves, Vegetations, and Valves.

We present a novel method for the treatment of right-sided bioprosthetic valve endocarditis with AngioVac debulking followed by percutaneous pulmonic and tricuspid valve replacement for residual transcatheter valve degeneration and right ventricular dysfunction.

Left Ventricle Biomechanics of Low-Flow, Low-Gradient Aortic Stenosis: A Patient-Specific Computational Model.

This study aimed to create an imaging-derived patient-specific computational model of low-flow, low-gradient (LFLG) aortic stenosis (AS) to obtain biomechanics data about the left ventricle. LFLG AS is now a commonly recognized sub-type of aortic stenosis. There remains much controversy over its management, and investigation into ventricular biomechanics may elucidate pathophysiology and better identify patients for valve replacement. ECG-gated cardiac computed tomography images from a patient with LFLG AS were obtained to provide patient-specific geometry for the computational model. Surfaces of the left atrium, left ventricle (LV), and outflow track were segmented. A previously validated multi-scale, multi-physics computational human heart model was adapted to the patient-specific geometry, yielding a model consisting of 91,000 solid elements. This model was coupled to a virtual circulatory system and calibrated to clinically measured parameters from echocardiography and cardiac catheterization data. The simulation replicated key physiologic parameters within 10% of their clinically measured values. Global LV systolic myocardial stress was 7.1 ± 1.8 kPa. Mean stress of the basal, middle, and apical segments were 7.7 ± 1.8 kPa, 9.1 ± 3.8 kPa, and 6.4 ± 0.4 kPa, respectively. This is the first patient-specific computational model of LFLG AS based on clinical imaging. Low myocardial stress correlated with low ejection fraction and eccentric LV remodeling. Further studies are needed to understand how alterations in LV biomechanics correlates with clinical outcomes of AS.

Impact of COVID-19 on Management Strategies for Coronary and Structural Heart Disease Interventions.

PURPOSE OF REVIEW: The COVID-19 pandemic has created unprecedented challenges globally, with significant strain on the healthcare system in the United States and worldwide. In this article, we review the impact of COVID-19 on percutaneous coronary interventions and structural heart disease practices, as well as the impact of the pandemic on related clinical research and trials. We also discuss the consensus recommendations from the scientific societies and suggest potential solutions and strategies to overcome some of these challenges. FINDINGS: With the limited resources and significant burden on the healthcare system during the pandemic, changes have evolved in practice to provide care to the highest risk patients while minimizing unnecessary exposure during elective surgical or transcatheter procedures. The COVID-19 crisis has significantly impacted the management of patients with acute coronary syndromes, chronic coronary syndromes, and structural heart disease.

Transcatheter Edge-to-Edge Repair of Systemic Tricuspid Valve in Extracardiac Fontan Circulation: First in Human.

Transcatheter edge-to-edge valve repair can improve clinical outcomes in otherwise high-risk surgical patients. This is a first-in-human procedure outlining transcatheter edge-to-edge valve repair of a systemic tricuspid valve in an extracardiac Fontan patient born with hypoplastic left heart syndrome with prohibitive surgical risk. (Level of Difficulty: Advanced.).

Outcomes among adult survivors of total cavopulmonary Fontan palliation for single ventricle.

OBJECTIVE: This tertiary centre study aims to identify factors associated with adverse outcomes in adult survivors with total cavopulmonary connection (TCPC) Fontan palliation for single ventricle. METHODS: This retrospective review of medical records identified adult (≥18 years) survivors of TCPC Fontan palliation who were followed at a single tertiary centre between 1 January 2000 and 1 July 2019. Adverse outcomes were defined as arrhythmia, pacemaker/implantable cardioverter defibrillator placement, liver cirrhosis, protein losing enteropathy, hospitalisation for heart failure, thromboembolic complication and/or death. RESULTS: 160 adult TCPC patients met the inclusion criteria: 117 (73.1%) extracardiac and 43 (26.9%) lateral tunnel. The median (IQR) duration of follow-up since TCPC palliation was 17.5 (11.8-21.3) years. An adverse outcome occurred in 87 (54.4%) patients. Adverse outcome-free survival rates at 10, 20 and 25 years post TCPC were 89% (95% CI 82% to 93%), 60% (95% CI 50% to 69%) and 24% (95% CI 15% to 35%), respectively. On multivariate analysis, extracardiac Fontan (HR 2.21, 95% CI 1.20 to 4.08, p=0.011) was observed to be an independent risk factor for adverse outcomes after adjusting for age, race, morphology of the systemic ventricle and history of fenestration. CONCLUSIONS: In this single-centre retrospective study of adult survivors of TCPC palliation, extracardiac Fontan was associated with an increased hazard for adverse outcomes. This finding could guide clinicians in developing risk modification strategies and management decisions to improve long-term outcomes in these patients.

A Simulation Study of the Effects of Number and Location of MitraClips on Mitral Regurgitation.

Background: MitraClip (MC) is a device that is implanted on the mitral valve (MV) percutaneously to treat severe mitral regurgitation (MR). It is common practice to place the MCs at the site of the most significant MR jets identified by echocardiography. Objectives: We used computational modeling to examine changes in MR after MC placement. Methods: Echocardiographic images from 29 patients with MR were analyzed to reconstruct geometries for finite element simulations and created fluid structure interaction models of the MV with deformable hyperelastic material, the left ventricle as the surrounding geometry, and blood flow. Blood flow was modelled with smoothed particle hydrodynamics. The number of blood particles on the atrial side of MV was used to estimate MR. MC placement was based on the MR jets (jet-based strategy using primary and secondary jets) and simulation models using various MCs locations. Results: Computational modelling was able to quantitate reductions in MR after MC placement. Reduction in MR was related to the number of MCs used: 42% reduction with 1 MC, 62% with 2 MCs, and 88% with 3 MCs. Using 2 MCs did not always result in an MR reduction greater than with a single MC. In 31% (9 of 29) of patients, the jet-based strategy did not lead to maximum MR reduction. The majority of patients (89%) who did not have maximal MR reduction with the MC placement using the jet-based strategy, had wide jets, and/or had multiple jets. Conclusions: Subject-specific simulation models may be helpful to identify optimal locations for MC placement in patients with MR.

Mitral Valve Atlas for Artificial Intelligence Predictions of MitraClip Intervention Outcomes.

Severe mitral regurgitation (MR) is a cardiac disease that can lead to fatal consequences. MitraClip (MC) intervention is a percutaneous procedure whereby the mitral valve (MV) leaflets are connected along the edge using MCs. The outcomes of the MC intervention are not known in advance, i.e., the outcomes are quite variable. Artificial intelligence (AI) can be used to guide the cardiologist in selecting optimal MC scenarios. In this study, we describe an atlas of shapes as well as different scenarios for MC implantation for such an AI analysis. We generated the MV geometrical data from three different sources. First, the patients' 3-dimensional echo images were used. The pixel data from six key points were obtained from three views of the echo images. Using PyGem, an open-source morphing library in Python, these coordinates were used to create the geometry by morphing a template geometry. Second, the dimensions of the MV, from the literature were used to create data. Third, we used machine learning methods, principal component analysis, and generative adversarial networks to generate more shapes. We used the finite element (FE) software ABAQUS to simulate smoothed particle hydrodynamics in different scenarios for MC intervention. The MR and stresses in the leaflets were post-processed. Our physics-based FE models simulated the outcomes of MC intervention for different scenarios. The MR and stresses in the leaflets were computed by the FE models for a single clip at different locations as well as two and three clips. Results from FE simulations showed that the location and number of MCs affect subsequent residual MR, and that leaflet stresses do not follow a simple pattern. Furthermore, FE models need several hours to provide the results, and they are not applicable for clinical usage where the predicted outcomes of MC therapy are needed in real-time. In this study, we generated the required dataset for the AI models which can provide the results in a matter of seconds.