Assessment of the Severity of Aortic Regurgitation by Noninvasive Imaging : Non-invasive MMI for AR.

PURPOSE OF THE REVIEW: The role of multimodality imaging in the evaluation of patients with aortic regurgitation is summarized in this review. RECENT FINDINGS: The etiology (mechanism) of the aortic regurgitation and the severity of aortic regurgitation and hemodynamic consequences are key in the decision making of patients with severe aortic regurgitation. While echocardiography remains as the leading technique to assess all these parameters, other imaging techniques have become essential for the accurate assessment of aortic regurgitation severity and the timing of aortic intervention. The anatomic suitability of transcatheter aortic valve implantation in inoperable patients with severe aortic regurgitation is usually assessed with computed tomography. Aortic regurgitation is a prevalent disease with various pathophysiological mechanisms that need a personalized treatment. The evaluation of the mechanism and severity of aortic regurgitation can be initially performed with echocardiography. Three-dimensional techniques, including echocardiography, have become very relevant for accurate assessment of the regurgitation severity and its hemodynamic consequences. Assessment of myocardial tissue characteristics with cardiac magnetic resonance is key in the risk stratification of patients and in the timing of aortic intervention. Computed tomography is important in the assessment of aortic dimensions and selection of patients for transcatheter aortic valve implantation.

Transcatheter Tricuspid Valve Replacement: A Feasible Solution to a Real-world Problem.

Background and Objective: As one of the most prevalent valvular pathologies affecting millions globally, moderate-to-severe tricuspid regurgitation (TR) predisposes to increased mortality. Despite the well-established risk of adverse outcomes, an overwhelming majority of TR patients are managed conservatively due to challenges associated with timely diagnosis, clinical course of the disease, competing comorbities that carry prohibitive surgical risk, and poor surgical outcomes. These challenges highlight the importance of transcatheter tricuspid valve replacement (TTVR) which has restructured TR management in promising and innovative ways. Methods: We start with an overview of the pathophysiology of TR considering its implications in management. We then elaborate on the current state of TR management, including its limitations, thereby highlighting the unique role of TTVR. This is followed by a review of perioperative considerations such as careful patient selection, role of multimodality imaging, the various imaging techniques that are available and their contribution towards successful TTVR. We then review the valves that are currently available and under investigation, including the latest data available on device efficacy and safety, and highlight the ongoing clinical trials. Results and Conclusions: TTVR is evolving at an exponential pace and has made its mark in the treatment of severe symptomatic tricuspid regurgitation. The promising results sustained by currently available devices and ongoing investigation of valves under development continue to pave the path for further innovation in transcatheter interventions. However, it is important to acknowledge and appreciate the novelty of this approach, the lack of long-term data on safety, efficacy, morbidity, and mortality, and use the lessons learned from real-world experiences to provide a definitive and reproducible solution for patients with symptomatic TR.

Three-Dimensional Echocardiography for Tricuspid Valve Assessment.

PURPOSE OF REVIEW: This review article provides an overview of the various roles of 3-dimensional (3D) echocardiography in the evaluation of the tricuspid valve (TV) with specific focus on tricuspid regurgitation (TR) and its treatment. RECENT FINDINGS: The prognostic implications of TR and the advent of new transcatheter therapies have underscored the need of accurate assessment of the TV. 3D echocardiography is key to assess the anatomy and function of TV and has provided new insights that have led to new classifications of the type of TR. Furthermore, 3D echocardiography is superior to 2-dimensional echocardiography to assess the right ventricle, an important parameter to select the patients with severe TR who may benefit from intervention. Finally, the use of 3D echocardiography during the guidance of transcatheter interventions is pivotal to ensure procedural success and minimize the complications. Three-dimensional echocardiography provides the soft tissue resolution that fluoroscopy does not provide.

Transcatheter Tricuspid Valve Interventions: An Emerging Field.

PURPOSE OF REVIEW: This review aims to provide an updated overview and a clinical perspective on novel transcatheter tricuspid valve interventions (TTVI), highlighting potential challenges and future directions. RECENT FINDINGS: Severe tricuspid regurgitation (TR) is a predictor of mortality. However, a sizeable number of patients remain untreated until the end-stage when cardiac surgery presents a prohibitive risk. The emergent need in finding a treatment for patients with TR, deemed for surgery options, has encouraged the development of TTVI. These procedures mimic classical surgery techniques and are mainly divided in four categories: annuloplasty and coaptation devices, edge-to-edge techniques and transcatheter tricuspid valve replacement. Early studies showed promising results, but long-term follow-up data are not available. For patients with severe TR and high surgical risk, several percutaneous options are available. However, these therapies are in a growing phase and bigger studies and long term follow-up are needed to prove their efficacy.

Effects of tricuspid transcatheter edge-to-edge repair on tricuspid annulus diameter - Data from the TriValve registry.

AIMS: T-TEER is an effective therapy for the treatment of tricuspid regurgitation (TR). However, the effects of leaflets clipping on tricuspid valve annulus (TA) have not been investigated in detail. The aim of this study is to investigate the effects of tricuspid transcatheter edge-to-edge repair (T-TEER) on TA diameter. METHODS AND RESULTS: The TriValve registry (Transcatheter Tricuspid Valve Therapies, NCT03416166) collected 556 patients from 22 European and North American centres undergoing transcatheter tricuspid valve interventions from 2016 to 2022. Patients undergoing T-TEER with available pre- and post-procedural data on TA diameter measured in the apical 4-chamber view on transthoracic echocardiography were selected for this study. Primary end-point was the reduction of TA diameter after T-TEER. A total of 186 patients were included in the study. In 115 patients (62%) TA diameter was reduced by at least 1 mm as compared to baseline. A significant reduction of TA dimension was observed following T-TEER (mean 2.3 mm [from pre-procedural diameter 46.7 mm to post-procedural diameter 44.4 mm], p < 0.001). In particular, the greatest reduction was observed in those with T-TEER in antero-septal commissure (mean 2.7 mm [from 47.1 mm to 44.4 mm], p < 0.001) as compared to those combining both antero-septal and postero-septal commissures (mean 1.4, from 46.0 mm to 44.6 mm, P = 0.06). A significant reduction of TA dimension was recorded in patients with 1 or 2 clips implanted but not in those patients with ≥3 clips implanted. CONCLUSIONS: In almost two third of patients T-TEER reduces TA diameter in addition to leaflet approximation. CONDENSED ABSTRACT: The effects of tricuspid transcatheter edge-to-edge repair (T-TEER) on tricuspid valve annulus (TA) have not been studied in details. This study investigates TA diameter as measured in apical 4-chamber view on transthoracic echocardiography before and after T-TEER. A total of 186 patients from the TriValve registry were included in the study. The study results show that 62% of patients have a TA reduction after T-TEER, especially in those receiving 1 or 2 clips in the antero-septal commissure. These suggest that T-TEER reduces tricuspid regurgitation not only by approximation of leaflets, but also by TA diameter reduction.

Mitral regurgitation evolution after transcatheter tricuspid valve interventions - a sub-analysis of the TriValve Registry.

AIMS: Transcatheter tricuspid valve interventions (TTVI) are increasingly used to treat patients with significant tricuspid regurgitation (TR). The evolution of concurrent mitral regurgitation (MR) severity after TTVI is currently unknown and may be pivotal for clinical decision-making. The aim of this study was to assess the evolution of MR after TTVI and to identify predictors of MR worsening and improvement. METHODS AND RESULTS: This analysis is a substudy of the Trivalve Registry, an international registry designed to collect data on TTVI. This substudy included all patients with echocardiographic data on MR evolution and excluded those with a concomitant tricuspid and mitral transcatheter valve intervention or with a history of mitral valve intervention. The co-primary outcomes were MR improvement and worsening at two timepoints: pre-discharge and 2-month follow-up. This analysis included 359 patients with severe TR, mostly(80%) treated with tricuspid transcatheter edge-to-edge repair(T-TEER). MR improvement was found in 106(29.5%) and 99(34%) patients, while MR worsening in 34(9.5%) and 33(11%) patients at pre-discharge and 2-month follow-up, respectively. Annuloplasty and heterotopic replacement were associated with MR worsening. Independent predictors of MR improvement were: atrial fibrillation, T-TEER, acute procedural success, TR reduction, LVEDD>60 mm and beta-blocker therapy. Patients with moderate-to-severe/severe MR following TTVI showed significantly higher death rates. CONCLUSION: MR degree variation is common after TTVI, with most cases showing improvement. Clinical and procedural characteristics may predict the MR evolution, in particular procedural success and T-TEER play key roles in MR outcomes. TTVI may be beneficial even in the presence of functional MR.

Characteristics and outcomes of patients with atrial versus ventricular secondary tricuspid regurgitation undergoing tricuspid transcatheter edge-to-edge repair - Results from the TriValve registry.

AIM: Functional or secondary tricuspid regurgitation (STR) is the most common phenotype of tricuspid regurgitation (TR) with atrial STR (ASTR) and ventricular STR (VSTR) being recently identified as two distinct entities. Data on tricuspid transcatheter edge-to-edge repair (T-TEER) in patients with STR according to phenotype (i.e. ASTR vs. VSTR) are lacking. The aim of this study was to assess characteristics and outcomes of patients with ASTR versus VSTR undergoing T-TEER. METHODS AND RESULTS: Patients with STR undergoing T-TEER were selected from the Transcatheter Tricuspid Valve Therapies (TriValve) registry. ASTR was defined by (i) left ventricular ejection fraction ≥50%, (ii) atrial fibrillation, and (iii) systolic pulmonary artery pressure <50 mmHg. Patients not matching these criteria were classified as VSTR. Patients with primary TR and cardiac implantable electronic device were excluded. Key endpoints included procedural success and survival at follow-up. A total of 298 patients were enrolled in the study: 65 (22%) with ASTR and 233 (78%) with VSTR. Procedural success was similar in the two groups (80% vs. 83% for ASTR vs. VSTR, p = 0.56) and TEER was effective in reducing TR in both groups (from 97% of patients with baseline TR ≥3+ to 23% in ASTR and to 15% in VSTR, all p = 0.001). At 12-month follow-up, survival was significantly higher in the ASTR versus VSTR cohort (91% vs. 72%, log-rank p = 0.02), with VSTR being an independent predictor of mortality at multivariable analysis (hazard ratio 4.75). CONCLUSIONS: In a real-world, multicentre registry, T-TEER was effective in reducing TR grade in both ASTR and VSTR. At 12-month follow-up, ASTR showed better survival than VSTR.

Echocardiographic Imaging of the Tricuspid Valve: Preprocedural Planning and Intraprocedural Guidance.

Transcatheter tricuspid valve (TV) interventions have increased dramatically in recent years. TV imaging is challenging in many respects. Given the TV's anatomic complexity, multimodality imaging, which is centered on echocardiography (echo), plays a significant part in planning and execution of these interventions. With the help of echo-guided imaging, pathophysiologic mechanisms for TV disease are better understood, and thus, appropriate valve intervention can be strategized. Novel devices for the TV continue to be developed, and thus, intraprocedural echo imaging will continue to evolve in the days ahead.

Atrial Functional Tricuspid Regurgitation as a Distinct Pathophysiological and Clinical Entity: No Idiopathic Tricuspid Regurgitation Anymore.

Functional tricuspid regurgitation (FTR) is a strong and independent predictor of patient morbidity and mortality if left untreated. The development of transcatheter procedures to either repair or replace the tricuspid valve (TV) has fueled the interest in the pathophysiology, severity assessment, and clinical consequences of FTR. FTR has been considered to be secondary to tricuspid annulus (TA) dilation and leaflet tethering, associated to right ventricular (RV) dilation and/or dysfunction (the "classical", ventricular form of FTR, V-FTR) for a long time. Atrial FTR (A-FTR) has recently emerged as a distinct pathophysiological entity. A-FTR typically occurs in patients with persistent/permanent atrial fibrillation, in whom an imbalance between the TA and leaflet areas results in leaflets malcoaptation, associated with the dilation and loss of the sphincter-like function of the TA, due to right atrium enlargement and dysfunction. According to its distinct pathophysiology, A-FTR poses different needs of clinical management, and the various interventional treatment options will likely have different outcomes than in V-FTR patients. This review aims to provide an insight into the anatomy of the TV, and the distinct pathophysiology of A-FTR, which are key concepts to understanding the objectives of therapy, the choice of transcatheter TV interventions, and to properly use pre-, intra-, and post-procedural imaging.

1-Year Outcomes of Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study.

BACKGROUND: Tricuspid regurgitation (TR) is prevalent and undertreated, with mortality and morbidity increasing with TR severity. Given poor outcomes with medical therapy and high in-hospital mortality for isolated tricuspid valve surgery, emerging transcatheter repair devices offer a promising alternative. OBJECTIVES: The Edwards Cardioband Tricuspid Valve Reconstruction System Early Feasibility study (NCT03382457) evaluates the treatment of functional TR via annular reduction with the Cardioband Tricuspid Valve Reconstruction System (Edwards Lifesciences). METHODS: Patients with ≥ moderate functional TR were eligible for this prospective, single-arm multicenter study. At 1 year, patients were evaluated for echocardiographic parameters, clinical and quality-of-life measures, and major adverse events. RESULTS: The 37 patients enrolled had a mean age of 78 years; 76% were female; and they had ≥ severe functional (97.3%) or mixed (2.7%) TR, atrial flutter/fibrillation (97%), and New York Heart Association functional class III/IV (65%). At 1 year, 73.0% achieved ≤ moderate TR (P < 0.0001), and 73.1% had ≥2 grade reductions. Echocardiography showed significant reductions in the tricuspid annulus diameter (P < 0.0001), mean vena contracta (P < 0.0001), proximal isovelocity surface area effective regurgitant orifice area (P < 0.0001), right ventricular end-diastolic diameter (P < 0.0001), and inferior vena contracta (P = 0.0006). New York Heart Association functional class improved significantly (P < 0.0001), with 92.3% achieving class I/II, and Kansas City Cardiomyopathy Questionnaire scores improved by 19.0 points (P < 0.0001). One-year cardiovascular mortality was 8.1%, reinterventions were necessary in 5.4%, major access site complications occurred in 8.1%, and severe bleeding was noted in 35.1% of patients. Kaplan-Meier estimates of survival and freedom from heart failure rehospitalization were 85.9% and 88.7%, respectively. CONCLUSIONS: One-year experience using the Cardioband system for tricuspid valve repair shows high survival and low rehospitalization rates with durable outcomes in TR reduction and echocardiographic, clinical, and quality-of-life outcomes.

Innovative medical technologies in the percutaneous treatment of tricuspid regurgitation in Poland.

Tricuspid regurgitation (TR) usually develops secondarily to left-sided heart diseases, whereas primary lesions to the valve apparatus is less common. Untreated severe TR has a poor prognosis and surgical treatment, i.e., valve repair or replacement, is the only treatment option with class I recommendation. However, cardiac surgical procedures may be associated with a high risk of complications. Recent advances in percutaneous approaches to managing structural heart diseases, especially mitral valve diseases, have enabled the implementation of this therapeutic strategy in the population of patients with TR. This paper presents data on the clinical efficacy, cost-effectiveness and expected population size for one of these procedures, namely the TriClip TTVr System procedure. Its efficacy was assessed in the TRILUMINATE study involving 85 patients with co-morbidities and at high surgical risk. After 1 year of follow-up, the reduction in the TR grade was reported in 71% of patients. Clinical improvement in New York Heart Association functional class, a 6-minute walk test, and the quality of life were also observed. A published analysis comparing percutaneous treatment modalities with a drug therapy based on data from medical registers was utilized, and propensity score matching was also employed. Percutaneous treatment reduced 1-year mortality and rehospitalization risk. The economic analysis showed the use of TriClip TTVr System is cost-effective: the cost of an additional quality-adjusted life year ranged from approximately PLN 85,000 to PLN 100,000, which is below the official threshold in Poland. The potential annual number of candidates for this treatment modality in Poland is estimated at 265.

Transcatheter tricuspid valve intervention techniques and procedural steps for the treatment of tricuspid regurgitation: a review of the literature.

Severe tricuspid regurgitation (TR) is an undertreated common pathology associated with significant morbidity and mortality. Classically, surgical repair or valve replacement were the only therapeutic options and are associated with up to 10% postprocedural mortality. Transcatheter tricuspid valve interventions are a novel and effective therapeutic option for the treatment of significant TR. Several devices have been developed with different mechanisms of action. They are classified as annuloplasty devices, replacement devices, caval valve implantation and coaptation devices. In this review, we provide a step-by-step description of the procedural steps and techniques of every device along with video support.

Challenges and future perspectives of transcatheter tricuspid valve interventions: adopt old strategies or adapt to new opportunities?

Tricuspid regurgitation (TR) is a highly prevalent valvular heart disease and is associated with an increased risk of cardiovascular events and death at long-term follow-up. Functional TR accounts for over 90% of TR and is mainly due to annular or right ventricular dilatation. Most often, TR is observed in patients with left-sided valvular heart disease (with or without previous surgical correction) and pulmonary hypertension. Isolated TR is less frequent, though burdened by high surgical mortality. This, together with an incomplete understanding of the disease, has brought to a significant undertreatment in spite of the growing evidence of the impact of severe TR on mortality. Moreover, uncertainties about the appropriate timing for intervention and the predictors of procedural success have contributed to limit TR treatment. Transcatheter tricuspid valve replacement or repair interventions represent novel and less invasive alternatives to surgery and have shown early promising results. The purpose of this review is to provide a complete and updated overview of TR pathology with a special focus on current percutaneous treatment options, future challenges and directions.

Advances in Clinical Cardiology 2021: A Summary of Key Clinical Trials.

INTRODUCTION: Over the course of 2021, numerous key clinical trials with valuable contributions to clinical cardiology were published or presented at major international conferences. This review seeks to summarise these trials and reflect on their clinical context. METHODS: The authors reviewed clinical trials presented at major cardiology conferences during 2021 including the American College of Cardiology (ACC), European Association for Percutaneous Cardiovascular Interventions (EuroPCR), European Society of Cardiology (ESC), Transcatheter Cardiovascular Therapeutics (TCT), American Heart Association (AHA), European Heart Rhythm Association (EHRA), Society for Cardiovascular Angiography and Interventions (SCAI), TVT-The Heart Summit (TVT) and Cardiovascular Research Technologies (CRT). Trials with a broad relevance to the cardiology community and those with potential to change current practice were included. RESULTS: A total of 150 key cardiology clinical trials were identified for inclusion. Interventional cardiology data included trials evaluating the use of new generation novel stent technology and new intravascular physiology strategies such as quantitative flow ratio (QFR) to guide revascularisation in stable and unstable coronary artery disease. New trials in acute coronary syndromes focused on shock, out of hospital cardiac arrest (OOHCA), the impact of COVID-19 on ST-elevation myocardial infarction (STEMI) networks and optimal duration/type of antiplatelet treatment. Structural intervention trials included latest data on transcatheter aortic valve replacement (TAVR) and mitral, tricuspid and pulmonary valve interventions. Heart failure data included trials with sodium-glucose cotransporter 2 (SGLT2) inhibitors, sacubitril/valsartan and novel drugs such as mavacamten for hypertrophic cardiomyopathy (HCM). Prevention trials included new data on proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors. In electrophysiology, new data regarding atrial fibrillation (AF) screening and new evidence for rhythm vs. rate control strategies were evaluated. CONCLUSION: This article presents a summary of key clinical cardiology trials published and presented during the past year and should be of interest to both practising clinicians and researchers.

Potential Candidates for Transcatheter Tricuspid Valve Intervention After Transcatheter Aortic Valve Replacement: Predictors and Prognosis.

OBJECTIVES: The aims of this study were to document the prevalence of concomitant tricuspid regurgitation (TR) before and after transcatheter aortic valve replacement (TAVR), to quantify potential eligibility for transcatheter tricuspid valve intervention (TTVI), and to report clinical outcomes as a function of the severity of TR and potential candidacy for TTVI. BACKGROUND: The importance of concomitant TR in patients with severe aortic stenosis undergoing TAVR remains unclear. METHODS: In a prospective TAVR registry, the severity of TR before and after TAVR was retrospectively evaluated in an echocardiography core laboratory. RESULTS: Among 2,008 eligible patients, 1,659 patients (82.6%) had mild or less TR, 242 (12.1%) had moderate TR, 57 (2.8%) had severe TR, and 50 (2.5%) had massive TR. More than one-half of patients with moderate or greater TR had a reduction in TR, while a small proportion of patients with severe or less of TR had worsening of TR after TAVR. In contrast to TR at baseline, severe TR (adjusted HR [HRadjusted]: 1.90; 95% CI: 1.03-3.49) and massive TR (HRadjusted: 2.17; 95% CI: 1.10-4.30) after TAVR conferred an increased risk for mortality compared with mild or less TR at 1 year after TAVR. After TAVR, 63 patients (3.1%) were deemed potential candidates for TTVI. They had a 2-fold increased risk for mortality between 30 days and 1 year (HRadjusted: 1.93; 95% CI: 1.15-3.25) and a higher risk for persistent heart failure symptoms (adjusted risk ratio: 2.80; 95% CI: 1.78-4.40). CONCLUSIONS: A non-negligible proportion of patients were considered potential candidates for TTVI after TAVR and had impaired prognosis and persistently impaired functional status at 1 year. (SwissTAVI Registry; NCT01368250).

Transcatheter innovations in tricuspid regurgitation: FORMA device.

Transcatheter tricuspid valve interventions (TTVIs) have arisen in recent years as an alternative treatment of tricuspid regurgitation (TR) in high risk patients. TTVIs can be classified as annuloplasty devices, caval valve implantation (CAVI), tricuspid valve replacement and coaptation devices. The FORMA repair system (Edwards Lifesciences, Irvine, CA, USA) aims to improve the coaptation of tricuspid leaflets by occupying the regurgitant orifice with a balloon spacer, which reduces the regurgitant orifice area. After the first-in-human reported case back in 2015, data from 18 patients treated under compassionate clinical use conditions and from 29 patients under the US early feasibility (EFS) trial have been published. The two studies included very high-risk surgical patients (Euroscore II >8 in both cohorts). Implantation success was achieved in 16 (89%) and 27 (93%) of patients, respectively. In the US EFS trial, results at 30 days showed improvements in New York Heart Association (NYHA) functional class (NYHA class ≥ III in 28% vs 84% at baseline, p =0.0002), 6-minute walking test (increase by 21 m, p =0.012) and in the Kansas City Cardiomyopathy Questionnaire (increase by 29 points, p < 0001). In addition, the Core Lab evaluation at 30 days showed statistically significant reductions in TR severity grading in the 25 available patients. Regarding the compassionate cohort, 15 patients had available data at long-term follow-up (≥ 2 years). NYHA functional class ≥ III was reduced from 93% to 34% (p <0.001). However, two-thirds of the patients remained with significant TR at last available follow-up, and there were no significant changes in EROA (0.92 vs. 0.77 cm2; p = 0.516). In conclusion, this first experience with the FORMA device showed the feasibility of the procedure. Despite the magnitude of TR reduction was moderate at long-term, significant improvements in heart failure symptoms and quality of life were achieved.