Tricuspid Valve Leaflets-Lead Interaction: Adjunctive Role of Functional Cardiac Computed Tomography for Clinical Decision Making.

The diagnostic approach toward the management of cardiac implantable electronic device-related tricuspid regurgitation is challenging and undefined. Functional cardiac computed tomography angiography provides a complementary role to echocardiography in the evaluation of lead-leaflet interaction which can help the clinical decision-making process, as presented in this case series.

Deformation in transcatheter heart valves: Clinical implications and considerations.

Transcatheter aortic valve replacement (TAVR) has emerged as a preferred treatment modality for aortic stenosis, marking a significant advancement in cardiac interventions. Transcatheter heart valves (THVs) have also received approval for treating failed bioprosthetic valves and rings across aortic, mitral, tricuspid, and pulmonic positions. Unlike surgically implanted valves, which are sewn into the annulus, THVs are anchored through relative oversizing. Although THVs are designed to function optimally in a fully expanded state, they exhibit a certain degree of tolerance to underexpansion. However, significant deformation beyond this tolerance can adversely affect the valve's hemodynamics and durability, ultimately impacting patient outcomes. Such post-implantation deviations from the valve's intended three-dimensional design are influenced by a variety of physiological and anatomical factors unique to each patient and procedure, leading to underexpansion, eccentric expansion, and vertical deformation. These deformation patterns increase leaflet stress and strain, potentially causing fatigue and damage. This review article delves into the extent of THV deformation, its impact on leaflet function, hypoattenuating leaflet thickening, and structural valve degeneration. It provides an in-depth analysis of deformation specifics in different procedural contexts, including TAVR in native aortic stenosis, aortic and mitral valve-in-valve procedures, and redo-TAVR. Additionally, the review discusses strategies to mitigate THV deformation during the procedure, offering insights into potential solutions to these challenges.

Preprocedural Computed Tomography Planning for Surgical Aortic Valve Replacement.

BACKGROUND: Selection of transcatheter valve size using preprocedural computed tomography (CT) is standardized and well established. However, valve sizing for surgical aortic valve replacement (SAVR) is currently performed intraoperatively by using sizers, which may result in variation among operators and risk for prosthesis-patient mismatch. This study evaluated the usefulness of CT annulus measurement for SAVR valve sizing. METHODS: This study included patients who underwent SAVR using Inspiris or Magna Ease and received preoperative electrocardiogram-gated CT imaging. Starting from June 2022, study investigators applied a CT sizing algorithm using CT-derived annulus size to guide minimum SAVR label size. The final decision of valve selection was left to the operating surgeon during SAVR. The study compared the appropriateness of valve selection (comparing implanted size with CT-predicted size) and prosthesis-patient mismatch rates without aortic root enlargement between 2 cohorts: 102 cases since June 2022 (CT sizing cohort) and 180 cases from 2020 to 2021 (conventional sizing cohort). RESULTS: Implanted size smaller than CT predicted size and severe prosthesis-patient mismatch were significantly lower by CT sizing than by conventional sizing (12% vs 31% [P = .001] and 0% vs 6% [P = .039], respectively). Interoperator variability was a factor associated with implanted size smaller than CT predicted with conventional sizing, whereas it became nonsignificant with CT sizing. CONCLUSIONS: Applying CT sizing to SAVR led to improved valve size selection, less prosthesis-patient mismatch, and less interoperator variability. CT sizing for SAVR could also be used to predict prosthesis-patient mismatch before SAVR and identify patients who need aortic root enlargement.

Tricuspid valve disease and cardiac implantable electronic devices.

The role of cardiac implantable electronic device (CIED)-related tricuspid regurgitation (TR) is increasingly recognized as an independent clinical entity. Hence, interventional TR treatment options continuously evolve, surgical risk assessment and peri-operative care improve the management of CIED-related TR, and the role of lead extraction is of high interest. Furthermore, novel surgical and interventional tricuspid valve treatment options are increasingly applied to patients suffering from TR associated with or related to CIEDs. This multidisciplinary review article developed with electrophysiologists, interventional cardiologists, imaging specialists, and cardiac surgeons aims to give an overview of the mechanisms of disease, diagnostics, and proposes treatment algorithms of patients suffering from TR associated with CIED lead(s) or leadless pacemakers.

Tricuspid Regurgitation: From Imaging to Clinical Trials to Resolving the Unmet Need for Treatment.

Tricuspid regurgitation (TR) is a highly prevalent and heterogeneous valvular disease, independently associated with excess mortality and high morbidity in all clinical contexts. TR is profoundly undertreated by surgery and is often discovered late in patients presenting with right-sided heart failure. To address the issue of undertreatment and poor clinical outcomes without intervention, numerous structural tricuspid interventional devices have been and are in development, a challenging process due to the unique anatomic and physiological characteristics of the tricuspid valve, and warranting well-designed clinical trials. The path from routine practice TR detection to appropriate TR evaluation, to conduction of clinical trials, to enriched therapeutic possibilities for improving TR access to treatment and outcomes in routine practice is complex. Therefore, this paper summarizes the key points and methods crucial to TR detection, quantitation, categorization, risk-scoring, intervention-monitoring, and outcomes evaluation, particularly of right-sided function, and to clinical trial development and conduct, for both interventional and surgical groups.

Comprehensive Myocardial Assessment by Computed Tomography: Impact on Short-Term Outcomes After Transcatheter Aortic Valve Replacement.

BACKGROUND: Quantification of myocardial changes in severe aortic stenosis (AS) is prognostically important. The potential for comprehensive myocardial assessment pre-transcatheter aortic valve replacement (TAVR) by computed tomography angiography (CTA) is unknown. OBJECTIVES: This study sought to evaluate whether quantification of left ventricular (LV) extracellular volume-a marker of myocardial fibrosis-and global longitudinal strain-a marker of myocardial deformation-at baseline CTA associate with post-TAVR outcomes. METHODS: Consecutive patients with symptomatic severe AS between January 2021 and June 2022 who underwent pre-TAVR CTA were included. Computed tomography extracellular volume (CT-ECV) was derived from septum tracing after generating the 3-dimensional CT-ECV map. Computed tomography global longitudinal strain (CT-GLS) used semi-automated feature tracking analysis. The clinical endpoint was the composite outcome of all-cause mortality and heart failure hospitalization. RESULTS: Among the 300 patients (80.0 ± 9.4 years of age, 45% female, median Society of Thoracic Surgeons Predicted Risk of Mortality score 2.80%), the left ventricular ejection fraction (LVEF) was 58% ± 12%, the median CT-ECV was 28.5% (IQR: 26.2%-32.1%), and the median CT-GLS was -20.1% (IQR: -23.8% to -16.3%). Over a median follow-up of 16 months (IQR: 12-22 months), 38 deaths and 70 composite outcomes occurred. Multivariable Cox proportional hazards model, accounting for clinical and echocardiographic variables, demonstrated that CT-ECV (HR: 1.09 [95% CI: 1.02-1.16]; P = 0.008) and CT-GLS (HR: 1.07 [95% CI: 1.01-1.13]; P = 0.017) associated with the composite outcome. In combination, elevated CT-ECV and CT-GLS (above median for each) showed a stronger association with the outcome (HR: 7.14 [95% CI: 2.63-19.36]; P < 0.001). CONCLUSIONS: Comprehensive myocardial quantification of CT-ECV and CT-GLS associated with post-TAVR outcomes in a contemporary low-risk cohort with mostly preserved LVEF. Whether these imaging biomarkers can be potentially used for the decision making including timing of AS intervention and post-TAVR follow-up will require integration into future clinical trials.

Imaging Methods for Evaluation of Chronic Aortic Regurgitation in Adults: JACC State-of-the-Art Review.

A global multidisciplinary workshop was convened to discuss the multimodality diagnostic evaluation of aortic regurgitation (AR). Specifically, the focus was on assessment tools for AR severity and analyzing evolving data on the optimal timing of aortic valve intervention. The key concepts from this expert panel are summarized as: 1) echocardiography is the primary imaging modality for assessment of AR severity; however, when data is incongruent or incomplete, cardiac magnetic resonance may be helpful; 2) assessment of left ventricular size and function is crucial in determining the timing of intervention; 3) recent evidence suggests current cutpoints for intervention in asymptomatic severe AR patients requires further scrutiny; 4) left ventricular end-systolic volume index has emerged as an additional parameter that has promise in guiding timing of intervention; and 5) the role of additional factors (including global longitudinal strain, regurgitant fraction, and myocardial extracellular volume) is worthy of future investigation.

Feasibility of Redo-Transcatheter Aortic Valve Replacement in Sapien Valves Based on In Vivo Computed Tomography Assessment.

BACKGROUND: Our aim was to assess the feasibility of repeat transcatheter aortic valve (TAV) replacement for degenerated Sapien3 (S3) prostheses by simulating subsequent implantation of S3 or Evolut, using in vivo computed tomography-based sizing and the impact on coronary and patient-prosthesis mismatch risks. METHODS: Computed tomography scans from 356 patients with prior S3 TAV replacement implantation were analyzed. The in vivo sizing for second TAV based on averaged area of 3 levels of outflow, mid (narrowest) and inflow, was compared with in vitro recommendations, that is, same size as index S3 for second S3 and 1 size larger for Evolut. Risks of coronary obstruction and patient-prosthesis mismatch were determined by valve-to-aorta distance and estimated effective orifice area, respectively. RESULTS: Overall, the majority of patients (n=328; 92.1%) had underexpanded index S3 with an expansion area of 94% (91%-97%), leading to significant differences in size selection of the second TAV between in vivo and in vitro sizing strategies. Expansion area <89% served as a threshold, resulting in 1 size smaller than the in vitro recommendations were selected in 45 patients (13%) for S3-in-S3 and 13 (4%) for Evolut-in-S3, while the remaining patients followed in vitro recommendations (P<0.01, in vivo versus in vitro sizing). Overall, 57% of total patients for S3-in-S3 simulation and 60% for Evolut-in-S3 were considered low risk for coronary complications. Deep index S3 implantation (odds ratio, 0.76 [interquartile range, 0.67-0.87]; P<0.001) and selecting Evolut as the second TAV (11% risk reduction in intermediate- or high-risk patients) reduced coronary risk. Estimated moderate or severe patient-prosthesis mismatch risk was 21% for S3-in-S3 and 1% for Evolut-in-S3, assuming optimal expansion of the second TAV. CONCLUSIONS: Redo-TAV replacement with S3-in-S3 and Evolut-in-S3 could be feasible with low risk to coronaries in ≈60% of patients, while the remaining 40% will be at intermediate or high risk. The feasibility of redo-TAV replacement is influenced by sizing strategy, type of second TAV, native annular anatomy, and implant depth.

An Elderly Woman With Ventricular Tachycardia.

A woman in her 90s presented to the emergency department with fever, hemoptysis, and syncopal episodes. An electrocardiogram showed monomorphic ventricular tachycardia with a morphology suggesting right ventricular (RV) origin. What would you do next?

Deformation of transcatheter heart valves with mitral valve-in-valve.

BACKGROUND: The use of oversizing in mitral valve-in-valve (MViV) procedures can lead to non-uniform expansion of transcatheter heart valves (THV). This may have implications for THV durability. AIMS: The objective of this study was to assess the extent and predictors of THV deformation in MViV procedures. METHODS: We examined 33 patients who underwent MViV with SAPIEN prostheses. The extent of THV deformation (deformation index, eccentricity, neosinus volume, asymmetric leaflet expansion and vertical deformation) and hypoattenuating leaflet thickening (HALT) were assessed using cardiac computed tomography (CT), performed prospectively at 30 days post-procedure. For descriptive purposes, the THV deformation index was calculated, with values >1.00 representing a more hourglass shape. RESULTS: Non-uniform underexpansion of THV was common after MViV implantation, with a median expansion area of 74.0% (interquartile range 68.1-84.1) at the narrowest level and a THV deformation index of 1.21 (1.13-1.29), but circularity was maintained with eccentricity ranging from 0.24 to 0.28. The degree of oversizing was a key factor associated with greater underexpansion and a higher deformation index (ß=-0.634; p<0.001; ß=0.594; p<0.001, respectively). Overall, the incidence of HALT on the 30-day postprocedural CT was 27.3% (9 of 33). Most patients (32 of 33) were on anticoagulation therapy, but the prothrombin time and international normalised ratio (PT-INR) at the time of the CT scan was <2.5 in 23 of 32 patients. Among patients with a PT-INR of <2.5, HALT was predominantly observed with a high THV deformation index of ≥1.18. CONCLUSIONS: THV deformation, i.e., underexpansion and an hourglass shape, commonly occurs after MViV implantation and is negatively affected by excessive oversizing. Optimising THV expansion during MViV could potentially prevent HALT.

Arrhythmic mitral valve prolapse and mitral annular disjunction: pathophysiology, risk stratification, and management.

Mitral valve prolapse (MVP) is the most frequent valve condition but remains a conundrum in many aspects, particularly in regard to the existence and frequency of an arrhythmic form (AMVP) and its link to sudden cardiac death. Furthermore, the presence, frequency, and significance of the anatomic functional feature called mitral annular disjunction (MAD) have remained widely disputed. Recent case series and cohorts have shattered the concept that MVP is most generally benign and have emphasized the various phenotypes associated with clinically significant ventricular arrhythmias, including AMVP. The definition, evaluation, follow-up, and management of AMVP represent the focus of the present review, strengthened by recent coherent studies defining an arrhythmic MVP phenotypic that would affect a small subset of patients with MVP at concentrated high risk. The role of MAD in this context is of particular importance, and this review highlights the characteristics of AMVP phenotypes and MAD, their clinical, multimodality imaging, and rhythmic evaluation. These seminal facts lead to proposing a risk stratification clinical pathway with consideration of medical, rhythmologic, and surgical management and have been objects of recent expert consensus statements and of proposals for new research directions.

Clinical Research on Transcatheter Aortic Valve Replacement for Bicuspid Aortic Valve Disease: Principles, Challenges, and an Agenda for the Future.

Bicuspid aortic valve disease (BAVD) is present in up to half of all patients referred for surgical aortic valve replacement (SAVR) yet was an exclusion criterion for all randomized controlled trials (RCTs) comparing transcatheter aortic valve replacement (TAVR) to SAVR. Nonetheless, approximately 10% of patients currently treated with TAVR have BAVD and available observational data for performing TAVR in these patients are limited by selection bias. Many in the cardiovascular community have advocated for RCTs in this population, but none have been performed. The Heart Valve Collaboratory (HVC) is a multidisciplinary community of stakeholders with the aim of creating significant advances in valvular heart disease by stimulating clinical research, engaging in educational activities, and advancing regulatory science. In December 2020, the HVC hosted a Global Multidisciplinary workshop involving over 100 international experts in the field. Following this 2-day symposium, working groups with varied expertise were convened to discuss BAVD, including the need for and design of RCTs. This review, conducted under the auspices of the HVC, summarizes available data and knowledge gaps regarding procedural therapy for BAVD, outlining specific challenges for trials in this population. We also propose several potential studies that could be performed and discuss respective strengths and weaknesses of each approach. Finally, we present a roadmap for future directions in clinical research in TAVR for BAVD with an emphasis both on RCTs and also prospective registries focused on disease phenotyping to develop parameters and risk scores that could ultimately be applied to patients to inform clinical decision-making.

Early safety and feasibility of a first-in-class biomimetic transcatheter aortic valve - DurAVR.

BACKGROUND: TAVI is a widely accepted treatment for patients with severe aortic stenosis (AS). Despite the adoption of diverse therapies, opportunities remain to develop technologies tailored to provide optimal acute and potential long-term benefits, particularly around haemodynamics, flow and durability. AIMS: We aimed to evaluate the safety and feasibility of the DurAVR transcatheter heart valve (THV), a first-in-class biomimetic valve, in the treatment of patients with symptomatic severe AS. METHODS: This was a first-in-human (FIH), prospective, non-randomised, single-arm, single-centre study. Patients with severe, symptomatic AS of any surgical risk and who were eligible for the DurAVR THV prosthesis were recruited; they were assessed at baseline, 30 days, 6 months, and 1 year post-procedure for implant success, haemodynamic performance, and safety. RESULTS: Thirteen patients (73.9±6.4 years old, 77% female) were enrolled. The DurAVR THV was successfully implanted in 100% of cases with no device-related complications. One access site complication, one permanent pacemaker implantation, and one case of moderate aortic regurgitation occurred. Otherwise, no deaths, stroke, bleeding, reinterventions, or myocardial infarction were reported during any of the follow-up visits. Despite a mean annulus size of 22.95±1.09 mm, favourable haemodynamic results were observed at 30 days (effective orifice area [EOA] 2.00±0.17 cm2, and mean pressure gradient [MPG] 9.02±2.68 mmHg) and were sustained at 1 year (EOA 1.96±0.11 cm2, MPG 8.82±1.38 mmHg), resulting in zero patients with any degree of prosthesis-patient mismatch. Additionally, new valve performance measures derived from cardiovascular magnetic resonance displayed restoration of laminar flow, consistent with a predisease state, in conjunction with a mean coaptation length of 8.3±1.7 mm. CONCLUSIONS: Preliminary results from the FIH study with DurAVR THV demonstrate a good safety profile with promising haemodynamic performance sustained at 1 year and restoration of near-normal flow dynamics. Further clinical investigation is warranted to evaluate how DurAVR THV may play a role in addressing the challenge of lifetime management in AS patients.

SCAI/HRS Expert Consensus Statement on Transcatheter Left Atrial Appendage Closure.

Exclusion of the left atrial appendage to reduce thromboembolic risk related to atrial fibrillation was first performed surgically in 1949. Over the past 2 decades, the field of transcatheter endovascular left atrial appendage closure (LAAC) has rapidly expanded, with a myriad of devices approved or in clinical development. The number of LAAC procedures performed in the United States and worldwide has increased exponentially since the Food and Drug Administration approval of the WATCHMAN (Boston Scientific) device in 2015. The Society for Cardiovascular Angiography & Interventions (SCAI) has previously published statements in 2015 and 2016 providing societal overview of the technology and institutional and operator requirements for LAAC. Since then, results from several important clinical trials and registries have been published, technical expertise and clinical practice have matured over time, and the device and imaging technologies have evolved. Therefore, SCAI prioritized the development of an updated consensus statement to provide recommendations on contemporary, evidence-based best practices for transcatheter LAAC focusing on endovascular devices.

SCAI/HRS expert consensus statement on transcatheter left atrial appendage closure.

Exclusion of the left atrial appendage to reduce thromboembolic risk related to atrial fibrillation was first performed surgically in 1949. Over the past 2 decades, the field of transcatheter endovascular left atrial appendage closure (LAAC) has rapidly expanded, with a myriad of devices approved or in clinical development. The number of LAAC procedures performed in the United States and worldwide has increased exponentially since the Food and Drug Administration approval of the WATCHMAN (Boston Scientific) device in 2015. The Society for Cardiovascular Angiography & Interventions (SCAI) has previously published statements in 2015 and 2016 providing societal overview of the technology and institutional and operator requirements for LAAC. Since then, results from several important clinical trials and registries have been published, technical expertise and clinical practice have matured over time, and the device and imaging technologies have evolved. Therefore, SCAI prioritized the development of an updated consensus statement to provide recommendations on contemporary, evidence-based best practices for transcatheter LAAC focusing on endovascular devices.