Search Results (75)

Background and Objectives: Left atrial appendage (LAA) closure is a Class I recommendation in patients with atrial fibrillation to reduce the risk of cardioembolic stroke. Achieving reliable and complete LAA exclusion during minimally invasive mitral valve surgery via right minithoracotomy remains technically challenging. We report here to our knowledge the largest series of a novel technique for LAA exclusion using an epicardial clip device applied via right minithoracotomy during minimally invasive mitral valve surgery. Materials and Methods: Between June 2023 and May 2026, 40 patients with atrial fibrillation underwent minimally invasive mitral valve surgery via right minithoracotomy with concomitant LAA exclusion. Cardiopulmonary bypass was established via percutaneous femoral cannulation. Following completion of the intracardiac procedure and prior to aortic cross-clamp removal, a suture was placed around the LAA base via the transverse sinus and used to guide clip deployment under direct vision. Successful closure was confirmed by intraoperative transesophageal echocardiography. Results: Mean patient age was 66.6 ± 8.0 years; 21 patients (53%) were female. Mitral valve repair was performed in 36 patients (90%) and replacement in 4 (10%). Concomitant cryoablation for AF was performed in 31 patients (78%). Successful LAA clip deployment was achieved in all 40 patients (100%). The 35 mm clip was used in 36 patients (90%), the 40 mm clip in 3 patients (8%), and the 45 mm clip in 1 patient (2%). Mean total operative time was 183 ± 58 min; mean CPB time was 134 ± 42 min; mean aortic cross-clamp time was 70 ± 27 min. In-hospital mortality was 0%. One patient (3%) required re-thoracotomy for bleeding, one developed a postoperative stroke, and two required ECMO support. Median hospital stay was 9 days. At discharge, 18 patients (45%) were in sinus rhythm; among the 31 who underwent concomitant cryoablation, 16 (52%) were discharged in sinus rhythm. Conclusions: Minimally invasive LAA exclusion is feasible and safe when performed via right minithoracotomy during minimally invasive mitral valve surgery. The technique achieves high rates of successful deployment and avoids the need for additional incisions or access sites. This approach represents a valuable addition to the armamentarium of concomitant stroke prevention strategies in patients with AF undergoing minimally invasive valvular surgery. Full article

Assessment of left atrial remodeling in atrial fibrillation (AF) has traditionally relied on anteroposterior diameter, left atrial volume (LAV), and indexed left atrial volume (LAVI). Although these measures remain clinically useful, they reduce a complex, asymmetric, and anatomically constrained chamber to scalar descriptors and therefore cannot fully capture the spatial substrate that underlies AF persistence, thromboembolic risk, or arrhythmia recurrence after catheter ablation. Three-dimensional left atrial reconstruction provides a more refined framework by preserving chamber shape, regional deformation, pulmonary vein (PV) orientation, left atrial appendage (LAA) geometry, posterior wall and roof configuration, left lateral ridge anatomy, wall-thickness heterogeneity, and computational surface features. In this review, we examine how three-dimensional left atrial geometry can extend conventional remodeling assessment from measurement of atrial size toward imaging-based substrate characterization. We discuss the relative strengths and limitations of computed tomography (CT), cardiovascular magnetic resonance (CMR), three-dimensional echocardiography, and electroanatomic mapping (EAM), and summarize key geometry-derived metrics, including LAV, LAVI, left atrial sphericity, asymmetry index, atrial eccentricity index, PV anatomy, LAA morphology, posterior wall geometry, wall thickness, radiomics, and artificial intelligence (AI)-derived shape descriptors. We further synthesize evidence linking geometric remodeling with atrial cardiomyopathy, mechanical dysfunction, fibrosis, low-voltage substrate, and catheter ablation outcomes. The clinical relevance of three-dimensional left atrial geometry may be further redefined by pulsed field ablation (PFA), whose non-thermal lesion biology and tissue selectivity may modify predictors of recurrence established in radiofrequency and cryoballoon cohorts. Finally, we outline the need for standardized segmentation, harmonized metric definitions, prospective multicenter validation, and integration with AI, digital twin modeling, biomarkers, EAM data, and wearable-derived AF burden. Three-dimensional left atrial geometry is not yet a standalone determinant of ablation strategy, but it may become a central component of individualized atrial phenotyping and rhythm-control decision-making. Full article

Background: The left atrial appendage (LAA) is the predominant site of thrombus formation in atrial fibrillation. Current percutaneous LAA occlusion devices require permanent implants. A catheter-based, non-implant mechanical inversion strategy may offer an alternative approach to stroke prevention. Objectives: To assess the feasibility of vacuum-assisted catheter-based inversion of the LAA using transseptal aspiration in a swine model. Methods: A 59-kg domestic swine underwent transseptal access via the right femoral vein under fluoroscopy, transesophageal echocardiography (TEE), and intracardiac echocardiography (ICE). A 22-F aspiration catheter was advanced into the left atrium and positioned at the LAA apex. Negative pressure was generated manually with a 60-mL syringe attached to the aspiration port, and sequential suction–traction maneuvers were performed to induce LAA inversion. Procedural feasibility, hemodynamic stability, imaging changes, and gross pathology were assessed. Results: LAA suction and inversion were feasible. Sequential negative pressure applications resulted in complete inversion, confirmed by multiplane TEE. A mild, non-hemodynamically significant pericardial effusion occurred. Necropsy showed focal apex injury consistent with catheter stiffness and suction forces. Conclusions: Catheter-based vacuum-assisted LAA inversion was technically feasible in this acute swine experiment. However, chronic survival studies are required to evaluate durability of inversion, tissue healing, thrombogenicity, and long-term safety before clinical translation can be considered. Full article

Atrial fibrillation (AF) is the most common tachyarrhythmia worldwide. Accompanying the increasing age of the general population, as well as an increase in underlying cardiovascular disease in the United States, is an explosive rise in the incidence and prevalence of this condition. We reviewed observational cohort studies, systematic reviews, meta-analyses, and randomized controlled trials (RCTs) to determine both underlying risk factors and treatment of AF, with particular focus on comorbid conditions influencing treatment success. Numerous studies have demonstrated a reciprocal relationship between maladaptive cardiac remodeling and AF, with the suggestion that aggressive management of both AF itself and resultant cardiovascular disease can lead to reversal of both conditions. Ultimately, many modifiable risk factors for AF exist, with treatment delays associated with a shift towards these conditions becoming unmodifiable. While a large area of focus for AF research has been on determining the optimal pharmacological strategy (i.e., rate versus rhythm control), results have been mixed, with emerging guidelines now pointing towards a flexible treatment strategy that allows for consideration of patient comorbid conditions, medication ease and affordability, and patient preference. Treatment of AF also includes prevention of thromboembolic events. In recent years, novel strategies for surgical or physical occlusion of the left atrial appendage (LAA) with devices such as the Watchman have arisen. Multiple large RCTs have demonstrated the safety and efficacy of these devices, but consideration must be given towards the patient’s bleeding risk, as short-term courses of blood thinners are still considered the standard of care. Finally, emerging therapies for AF include novel drug combinations, neuromodulation devices, and potentially glucagon-like peptide receptor-1 (GLP-1) agonist medications for reduction in overall metabolic disease. Full article

Background and Objectives: Atrial fibrillation (AF) is the most common cardiac arrhythmia, present in up to 14–20% of patients undergoing cardiac surgery, with the number of patients expected to double within the next decade. Despite a Class I recommendation for concomitant surgical ablation and a Class I-B recommendation for left atrial appendage (LAA) occlusion in patients with AF undergoing cardiac surgery (Class IIa for endoscopic or hybrid AF ablation), both procedures remain substantially underutilized in clinical practice. The design of the Mapping atrial fibrillation after Epicardial Surgical Ablation plus AtriClip to Guide Endocardial ablation (MESAGE) prospective study is presented. Materials and Methods: A narrative literature review was conducted using PubMed through March 2025. Randomized controlled trials, multicenter registries, meta-analyses and current clinical guidelines were prioritized. The MESAGE study protocol is presented in accordance with the SPIRIT recommendations. Results: Randomized evidence demonstrates that hybrid ablation achieves 32–48% greater arrhythmia freedom than catheter ablation (CA) alone in persistent and long-standing persistent AF, with comparable safety and significantly fewer interventions at two-year follow-up. Epicardial LAA occlusion with the AtriClip device achieves complete occlusion in all patients with an 87.5% relative reduction in ischemic stroke risk in anticoagulation-free follow-up. Continuous implantable loop recorder (ILR)-based monitoring reveals AF recurrence in substantially more patients than conventional monitoring, with AF burden emerging as a more meaningful endpoint than arrhythmia freedom. The MESAGE study enrolls 40 patients undergoing cardiac surgery who have pre-existing AF, pre-randomized 1:1 to pulmonary vein isolation (PVI) alone versus PVI-BOX, with mandatory pre-operative ILR implantation, intra-operative AtriClip LAA exclusion, and systematic Day-60 endocardial mapping and supplementary ablation using the Affera dual-energy system. Conclusions: Hybrid epicardial–endocardial ablation combined with LAA exclusion and continuous ILR monitoring represents a comprehensive, mechanistically rational and evidence-informed approach to AF management in patients undergoing cardiac surgery, although current evidence remains heterogeneous, and the benefits depend on the AF phenotype and monitoring strategy. The MESAGE pilot study will generate hypothesis-generating prospective comparative data on epicardial PVI versus PVI-BOX in the concomitant surgical setting, assessed through systematic post-surgical endocardial mapping and continuous rhythm monitoring. Full article

Background/Objectives: Persistent and long-standing persistent atrial fibrillation (AF) presents a therapeutic clinical challenge balancing complex rhythm management with a heightened stroke risk. The left atrial appendage (LAA) is the primary source of thromboembolisms in these patients. This study evaluated the safety and efficacy of combining LAA exclusion with Convergent Hybrid Ablation for stroke prevention and rhythm control in a refractory patient cohort. Methods: A single-center observational cohort study was conducted including 28 patients with symptomatic persistent or long-standing persistent AF. The cohort was highly refractory, with 82.1% having failed at least one endocardial catheter ablation. The hybrid procedure consisted of sub-xiphoid epicardial ablation, thoracoscopic LAA exclusion (AtriClip), and endocardial catheter ablation. Safety and efficacy were assessed at 3 months and 12 months. Results: LAA exclusion was successfully performed in 96.4% of patients. The peri-operative safety profile was acceptable, with zero procedure-related strokes or deaths. At the 12-month follow-up, the rate of stroke or any other major adverse events was at 0.0%. Freedom from AF was 75.0%, shown by a 12-lead electrocardiography (ECG). Freedom from any atrial arrhythmia off anti-arrhythmic drugs (AADs) was achieved in 50.0% of patients. A total of 32.1% of the cohort required catheter ablation within 12 months to maintain sinus rhythm as part of the hybrid treatment. Conclusions: Concomitant LAA exclusion during Convergent Hybrid Ablation is a safe procedure with a high clinical success rate in maintaining sinus rhythm in a highly complex AF patient group. While no thromboembolic events were observed at 12 months, larger studies with longer follow-up are needed to confirm the potential for long-term stroke risk reduction. The findings suggest that for many patients, the hybrid procedure should be viewed as part of a multi-step strategy often requiring endocardial “touch-up” ablation. Full article

Background: Atrial fibrillation (AF) remains the most common cardiac arrhythmia, with pulmonary vein isolation (PVI) established as the cornerstone of interventional treatment. However, in patients with persistent AF (PersAF), the success rates of PVI alone tend to be limited. A promising additional target is the left atrial appendage (LAA). In recent years, cryoballoon (CB) technology has become a tool for achieving durable PVI. Its application for LAAI has been investigated as a potentially advantageous alternative to radiofrequency ablation, and a positive effect on long-term outcome has been reported. However, the available data is limited. This study sought to investigate the clinical impact of CB-based LAAI in addition to PVI. Methods: This is a prospective, interventional, single-centre study. Consecutive patients with symptomatic PersAF were prospectively enrolled. In total 23 patients with PersAF underwent PVI plus LAAI using the CB system. Percutaneous LAA closure was performed within 2–3 months in all patients by implanting an endocardial LAA-closure device. Prior to LAA closure, LAAI durability was systematically assessed by invasive remapping studies. Results: A total of 100% of PVs were successfully isolated using the CB only (n = 91/91). Concerning LAAIs, a total of 21/23 (91%) remained isolated at the end of the procedure. After the ablation procedure including LAAI, all patients were scheduled for TEE assessment and LAA closure. TEE was performed after a mean of 54 ± 19 days. In 6/23 (26%) patients, LAA thrombus formation was detected after LAAI. A total of 23/23 patients (100%) received LAAC after a mean of 72 ± 45 days. Durability of LAAI was assessed utilizing a spiral mapping catheter in 23/23 patients (100%). In a total of 17/23 (74%) patients, durable LAA isolation was detected. Durable PVI of all PVs was detected in 16/23 (70%) patients. During a mean follow-up of 13 ± 3.4 months, stable sinus rhythm was maintained in 15 (65%) patients. The LAA showed reconnection in 3/23 (13%) patients, with arrhythmia recurrence. During follow-up, one stroke (318 days after LAAC) and one device thrombus (56 days after LAAC) occurred. Conclusions: While CB-based LAAI may offer benefits in managing persistent AF, it presents a significant risk of thrombus formation in the LAA, even with appropriate OAC. Early closure of the LAA following LAAI appears promising in mitigating these risks, but further evidence is needed to establish clear best practices. Full article

Recent studies have demonstrated that primary cilia not only play a role in cardiovascular development, but also in the progression of acquired heart disease. Their role in atrial fibrillation (AF) is incompletely understood. We hypothesize that there is a causal link between primary cilia genes and the occurrence of AF. We integrated AF GWAS data with various multi-omic datasets—including data on gene expression, DNA methylation, and protein expression quantitative trait loci (eQTL, mQTL, and pQTL)—from human left atrial appendage (LAA) tissues and blood. Genetic variants linked to primary cilia-related genes were used as instrumental variables to explore their causal links to AF, through summary-data-based Mendelian randomization (SMR) and Bayesian colocalization. Single-cell sequencing data were used to analyze the expression of the selected genes across different cell types. The mechanisms by which the selected genes exert their effects were explored using RNA sequencing data, clinical indicators, and immunohistochemical markers from 22 patients without AF from the PREDICT-AF cohort, and 21 patients with paroxysmal AF and 19 patients with persistent AF from the MARK-AF cohort. Through SMR analyses, we established significant associations between predicted CEP68 expression and AF in both blood (OR 1.25; 95% CI 1.18–1.33; false discovery rate (FDR) = 1.81 × 10⁻⁹) and LAA tissue (OR 1.12; 95% CI 1.08–1.16; FDR = 6.18 × 10⁻⁹). Moreover, predicted methylation of CEP68 showed an inverse relationship with AF risk (OR 0.87; 95% CI 0.84–0.90; FDR = 2.55 × 10⁻¹⁵). Colocalization results for CEP68 in both blood and the LAA indicated strong evidence of a shared causal variant. Within single-cell data, compared to the control group, AF patients had higher levels of CEP68 in fibroblasts (p = 0.046). In bulk RNA-seq data, CEP68 expression showed no significant differences among the no AF, paroxysmal AF, and persistent AF groups. CEP68 was positively correlated with the cardiac remodeling marker Thrombospondin-2 in 22 patients without AF from the PREDICT-AF cohort (r = 0.45, p = 0.03). In AF patients from the MARK-AF study, CEP68 was also positively associated with LAVI (r = 0.34, p = 0.03). Collectively, our results support a model in which genetically predicted CEP68 regulation is linked to AF liability and is consistent with fibroblast activation and remodeling-related pathways as potential mediators. Full article

The left atrial appendage (LAA) is a highly dynamic anatomical structure that plays a key role in left atrial reservoir function, pressure and volume modulation, and endocrine hormone secretion during sinus rhythm. However, its physiological contribution is profoundly altered in atrial fibrillation (AF). Electrical and structural remodeling, impaired contractility, and blood stasis within the LAA collectively transform this functional component into the principal cardiac source of thrombus formation and embolic events in patients with AF. This review focuses on the conceptual continuum from physiological LAA function in sinus rhythm to its pathological transformation in AF and the evolving rationale for progressively more complete (“radical”) anatomical exclusion A variety of strategies, including systemic anticoagulation therapy, percutaneous device-based exclusion, and surgical closure, are currently employed, each with specific indications, limitations, and procedure-related risks. Beyond summarizing available techniques, this review critically synthesizes mechanistic, anatomical, and clinical data to address unresolved controversies regarding patient selection, residual leaks, device-related thrombosis, and post-procedural antithrombotic management. Finally, emerging directions toward minimizing residual foreign material, reducing thrombogenicity, and achieving durable exclusion are discussed, supporting a more personalized and radical approach to stroke prevention in AF. Full article

Background: Left atrial appendage (LAA) closure is an alternative to oral anticoagulants (OAC) for stroke prevention in atrial fibrillation (AF), but comparative evidence remains inconsistent. This study systematically evaluates the efficacy and safety of LAA closure versus OAC in AF patients. Methods: We systematically searched PubMed, EmBase, Cochrane Library, and Web of Science for randomized controlled trials (RCTs) and propensity score-matched (PSM) studies published up to 30 September 2025. Treatment effects were estimated using relative risks (RR) with 95% confidence intervals (CI), and a random-effects model was applied for all analyses. Results: Fifteen studies (17,116 AF patients) were included, comprising 4 RCTs, 3 prospective PSM studies, and 8 retrospective PSM studies. Compared with OAC, LAA closure significantly reduced the composite endpoint (RR: 0.79; 95% CI: 0.66–0.95; p = 0.010), all-cause mortality (RR: 0.58; 95% CI: 0.49–0.69; p < 0.001), and cardiovascular mortality (RR: 0.55; 95% CI: 0.44–0.67; p < 0.001). Risks of any stroke (RR: 1.06; 95% CI: 0.86–1.31; p = 0.555), ischemic stroke (RR: 1.00; 95% CI: 0.85–1.17; p = 0.972), hemorrhagic stroke (RR: 0.96; 95% CI: 0.54–1.70; p = 0.879), and major bleeding (RR: 0.84; 95% CI: 0.67–1.04; p = 0.112) were not significantly different between groups. Conclusions: In AF patients, LAA closure significantly reduces mortality and a composite clinical endpoint compared to OAC, with similar risks of stroke and major bleeding. It is a favorable alternative for patients unsuitable for long-term anticoagulation. Full article

Traditional anticoagulants used in atrial fibrillation (AF) are being increasingly replaced by novel oral anticoagulants such as rivaroxaban, improving patient outcomes. Although rivaroxaban 20 mg/1× daily is approved to reduce stroke and systemic embolism risk in AF, some patients still develop thrombus in the left atrial appendage (LAA). A previous study demonstrated thrombus lysis with a modified regimen of rivaroxaban 15 mg/2× daily, yet over 50% of patients remained unresponsive despite therapeutic plasma levels. This study compared metabolic profiles of responders and non-responders to identify predictive markers of treatment efficacy. From the RIVA-TWICE study cohort (n = 249), 15 AF patients with LAA thrombus despite standard dosing were switched to 2 × 15 mg rivaroxaban. Plasma samples collected prior to dose modification underwent untargeted and targeted LC-MS analysis, focusing on acylcarnitines (ACs), carnitine, and its precursors. Thrombus resolution occurred in 7 (46.7%) patients, who showed differential abundance of metabolites related to alpha-linolenic acid and fatty acid metabolism, carnitine synthesis, and arginine/proline pathways. Targeted analysis confirmed elevated levels of ACs, carnitine, and precursors. Findings suggest that a patient phenotype, including carnitine, its precursors, and ACs, may predict rivaroxaban efficacy in thrombus lysis. While these metabolites may not directly mediate lysis, their elevated levels represent potential biomarkers of treatment response. Full article

Soft biological tissues display highly nonlinear and anisotropic mechanical behavior, which is critical to their physiological function. Replicating these mechanical properties using engineered materials and additive manufacturing represents a significant challenge in biomedical engineering, particularly for surgical simulation, device development, and preclinical testing. The left atrial appendage (LAA) was selected since it plays a central role in thrombus formation during atrial fibrillation, significantly contributing to cardioembolic stroke. This study proposes a framework for reproducing the nonlinear stress–strain behavior of soft tissue using 3D-printed models. The methodology integrates experimental material selection with optimization of key printing parameters to ensure structural reliability and functional mechanical performance. Two polymers—polyurethane (TPU) and a thermoplastic with elastomer-type behavior (TPE)—were selected for their tunable hardness and elasticity. A parametric study was conducted to investigate the effects of Shore A hardness (60A to 100A), infill density (0% to 100%), and external shell number (zero to two) on the tensile performance of printed models. Mechanical testing was performed to extract stress–strain curves and evaluate the mechanical response. The practical implications of this study are significant, demonstrating the potential of additive manufacturing for anatomical reproduction and replicating functional mechanical properties in soft tissue models. Full article

Background: Patients with atrial fibrillation (AF) who have a high bleeding risk or contraindications to anticoagulation may be candidates for left atrial appendage closure (LAAC). However, the presence of a thrombus in the left atrial appendage (LAA) is generally considered a contraindication to the procedure. While the feasibility and short-term safety of LAAC in patients with pre-existing LAA thrombus has been reported, data on long-term outcomes remain limited. Objective: To assess the long-term clinical outcomes of AF patients undergoing LAAC in the presence of an LAA thrombus. Methods: This retrospective, single-center registry included all AF patients who underwent LAAC between June 2010 and April 2024. Patients were stratified based on the presence or absence of LAA thrombus at the time of the procedure. The primary endpoint was a 5-year composite of stroke, systemic embolism, or all-cause mortality. Results: A total of 403 patients underwent LAAC, of whom 24 (6%) had an LAA thrombus at the time of the procedure. During a median follow-up of 3.9 years, the primary endpoint occurred in 116 patients: 110 events (41%) in the no-thrombus group and 6 events (38%) in the thrombus group. There was no statistically significant difference in major adverse cardiovascular events (MACE) between groups (log-rank p = 0.862). Conclusions: LAAC may be performed safely in selected patients with distal LAA thrombus, with long-term outcomes comparable to those without thrombus. Full article

Background/Objectives: Left atrial appendage (LAA) morphology has been implicated in atrial fibrillation (AF) recurrence following catheter ablation. However, the predictive value of specific anatomical shapes remains unclear. We aimed to evaluate the association between distinct LAA morphologies and AF recurrence post-ablation. Methods: In this retrospective, single-center study, 463 patients with AF undergoing first-time catheter ablation were included. Pre-ablation contrast-enhanced cardiac computed tomography was performed to classify LAA morphology into chicken-wing, windsock, cauliflower, and cactus types. Patients were followed for one year, with AF recurrence defined as documented atrial tachyarrhythmia episodes lasting more than 30 s occurring between 3 and 12 months post-procedure. Clinical, anatomical, and procedural factors were analyzed using multivariable logistic regression to identify independent predictors of recurrence. Results: Among the four morphologies, the windsock-type LAA had the highest recurrence rate at 48.3%, significantly greater than chicken-wing (25.2%), cauliflower (20.8%), and cactus (18.2%) types (p = 0.017). Multivariable analysis confirmed windsock morphology as an independent predictor for AF recurrence (adjusted OR = 2.720, 95% CI: 1.209–6.118; p = 0.016). Additionally, persistent AF (adjusted OR = 1.748, 95% CI: 1.075–2.842; p = 0.024) and antiarrhythmic drug use in the blanking period (adjusted OR = 2.862, 95% CI: 1.689–4.849; p < 0.001) independently increased the risk of recurrence. Conclusions: Windsock-type LAA morphology significantly predicts increased AF recurrence following catheter ablation, underscoring the importance of morphological assessment in ablation planning. Individualized strategies targeting high-risk LAA morphologies may enhance procedural success and reduce AF recurrence. Future prospective studies are warranted to validate these findings. Full article

Background: An accurate device sizing for percutaneous left atrial appendage closure (LAAC) can be challenging. Intraprocedural automated LAA evaluation by transoesophageal echocardiography (TEE) based on an artificial intelligence-assisted 3D model may facilitate sizing and prediction of C-arm angulation for device implantation in a one-stop-shop procedure. This study aimed to evaluate the feasibility and accuracy of automated echocardiographic LAA sizing based on a patient-specific 3D heart model prototype in real-time. Methods: A prospective monocentric study was conducted in 66 patients who underwent LAAC with the Amulet device. All major LAA morphologies were represented. Preprocedural multidetector computed tomography (MSCT) measurements and intraprocedural TEE and angiography measurements of the ostium, landing zone, and C-arm angulation were compared with the 3D heart model measurements. Results: The procedure achieved a 100% success rate. The measurements for the maximum diameter of the ostium in the 3D heart model were not significantly different from those obtained via angiography, TEE, and MSCT. Specifically, the maximum diameter of the landing zone did not differ significantly compared to TEE and angiographic measurements (20.90 ± 3.42 mm vs. 20.96 ± 4.81 mm, p = 0.563; compared to 21.20 ± 3.90 mm, p = 0.291). However, these measurements were significantly smaller than the average MSCT measurements (18.30 ± 2.68 mm vs. 21.03 ± 4.34 mm, p < 0.001). Additionally, the predicted implantation angles showed no significant differences between the 3D heart model and MSCT. Conclusions: The intraprocedural application of this prototype is both safe and feasible. The measurements obtained from the 3D heart model were consistent with those from TEE and angiography, although discrepancies were noted when compared to MSCT measurements. Notably, the predicted implantation angles demonstrated strong agreement with MSCT, further supporting the prototype’s efficacy in clinical settings. Full article