Transcatheter Tricuspid Valve Intervention Research Articles

Transcatheter Tricuspid Valve Therapy: From Anatomy to Intervention.

Nowadays, severe symptomatic tricuspid regurgitation (TR) affects millions of persons worldwide. However, the benefit of surgical correction of isolated secondary TR remains controversial because of the increased risk of periprocedural mortality and morbidity. In recent years, novel transcatheter tricuspid valve interventions (TTVI) were developed to treat TR, so that TTVI is currently considered in symptomatic, inoperable, anatomically eligible patients. TTVI can be divided into these five domains: edge-to-edge leaflet repair, tricuspid annuloplasty, caval implants, spacer, and total valve replacement. Each transcatheter intervention needs specific imaging protocols for assessing the anatomical feasibility and consequentially predicting the procedural success. This review summarizes the available multimodality imaging tools for screening patients with TR, and identifies anatomical characteristics to choose the best option for the patient.

Rediscovered and Unforgotten: Transcatheter Interventions for the Treatment of Severe Tricuspid Valve Regurgitation

Tricuspid valve regurgitation is both globally prevalent and undertreated. Historically, surgical intervention for isolated tricuspid regurgitation (TR) was avoided despite the prevalence of TR, largely due to poor surgical outcomes and an incomplete understanding of how it independently affects mortality. Over the past two decades, TR has been shown by several studies to be an independent predictor of worse functional status and poor survival on long-term follow-up. During this same time period, transcatheter interventions for the treatment of valvular heart disease have evolved dramatically. While the transcatheter repair and replacement of the tricuspid valve in patients with severe TR remains in the early stages of investigation relative to the mitral or aortic valve, the field is rapidly expanding. Here, the authors review the field of transcatheter tricuspid valve interventions for severe TR, focusing on the orthotropic devices and valves currently available worldwide.

TCT-138 Right Ventricular Remodeling and Clinical Outcomes Following Transcatheter Tricuspid Valve Intervention

TCT-138 Right Ventricular Remodeling and Clinical Outcomes Following Transcatheter Tricuspid Valve Intervention

Transcatheter treatment for tricuspid valve disease.

Approximately 4% of subjects aged 75 years or more have clinically relevant tricuspid regurgitation (TR). Primary TR results from anatomical abnormality of the tricuspid valve apparatus and is observed in only 8-10% of the patients with tricuspid valve disease. Secondary TR is more common and arises as a result of annular dilation caused by right ventricular enlargement and dysfunction as a consequence of pulmonary hypertension, often caused by left-sided heart disease or atrial fibrillation. Irrespective of its aetiology, TR leads to volume overload and increased wall stress, both of which negatively contribute to detrimental remodelling and worsening TR. This vicious circle translates into impaired survival and increased heart failure symptoms in patients with and without reduced left ventricular ejection fraction. Interventions to correct TR are underutilised in daily clinical practice owing to increased surgical risk and late patient presentation. The recently introduced transcatheter tricuspid valve interventions aim to address this unmet need. Dedicated expertise and an interdisciplinary Heart Team evaluation are essential to integrate these new techniques successfully and select patients. The present article proposes a standardised approach to evaluate patients with TR who may be candidates for transcatheter interventions. In addition, a state-of-the-art review of the available transcatheter therapies, the main criteria for patient and device selection, and information concerning the remaining uncertainties are provided.

Echocardiographic Imaging for Transcatheter Tricuspid Valve Interventions

Echocardiographic Imaging for Transcatheter Tricuspid Valve Interventions

A Practical Approach to Combined Transcatheter Mitral and Tricuspid Valve Intervention.

Concomitant tricuspid regurgitation (TR) is common in patients with mitral regurgitation (MR). While current guidelines recommend repair of both valves at the time of surgery when feasible, high risk patients are often undertreated, leading to significant morbidity and mortality. With advances in transcatheter edge-to-edge repair (TEER) devices and technique, combined TEER for treating significant MR and TR has emerged as a new tool for heart failure management. Recent evidence has shed light on which patients with severe TR should be targeted for transcatheter intervention either in isolation or in combination with a MV TEER procedure and allows for expanded treatment options in patients who otherwise would be limited to medical management. Technological advancements remain ahead of robust clinical data, and thus randomized clinical studies in patients with severe MR and TR will be instrumental in determining the best approach in treating these patients with transcatheter therapies.

Predicting procedural success in patients treated with Cardioband system for severe tricuspid regurgitation by employing a random forest algorithm

Abstract Background Severe tricuspid regurgitation (TR) is associated with high morbidity and mortality despite optimal medical treatment. Transcatheter tricuspid valve intervention (TTVI) is therefore emerging as a novel treatment option, fueling the hope to prolong survival and reduce rehospitalization for heart failure. Obviously, procedural success of TTVI is an important determinant of survival, but predictors for procedural success in patients treated with Cardioband system, which mimics the surgical approach by implanting an annular reduction system and hence targets tricuspid annulus dilatation as the central pathology in most patients, are largely elusive. Purpose This study aims to refine prediction of procedural success in patients with severe TR undergoing TTVI with Cardioband system by employing a random forest algorithm. Methods Procedural success was evaluated in 72 patients enrolled at two tertiary centers in Germany between 2018 and 2020. Key inclusion criterion was TR ≥ III/V° with high symptomatic burden despite optimal medical treatment. Procedural success war defined as patient alive at the end of the procedure, successful Cardioband implantation, and TR reduction ≥ II/V° as assessed on transthoracic echocardiography before discharge. Since 66.7% of patients were classified as “success”, a synthetic minority over-sampling technique was applied in order to train the random forest algorithm on a balanced data set. Results A random forest algorithm reached 85.4% accuracy (AUC: 0.923) in predicting procedural success in a balanced data set using eight parameters from pre-procedural echocardiography as input variables. Partial dependence analysis revealed that enlargement of the tricuspid valve (TV) anteroseptal diameter was most important for model accuracy. Applied to the real-world data set (24 patients classified as “failure” and 48 patients classified as “success”), the now trained random forest algorithm predicted procedural success with high sensitivity (70.8%) and specificity (100.0%), significantly outperforming the no information rate (p-value: 0.0069). Patients with low probability for success were characterized by impaired right ventricular function (TAPSE: 15.5±3.63 mm) and enlarged right sided cardiac diameters (basal right ventricular diameter: 51.6±3.79 mm; TV anteroseptal diameter: 45.0±5.10 mm). Notably, systolic pulmonary artery pressure (sPAP) and TV effective regurgitant orifice area were negatively correlated (R: −0.3004, p-value: 0.0322), and elevation in sPAP was attenuated in patients with low probability for procedural success (sPAP: 34.0±11.7 mmHg). Conclusion A random forest algorithm enables precise prediction of procedural success in patients treated with Cardioband system. TR reduction ≥ II/V° appears less achievable in patients with advanced stages of right heart failure, emphasizing the importance of adequate patient selection and timing of intervention. Funding Acknowledgement Type of funding sources: None.

Potential candidates for transcatheter tricuspid valve interventions after transcatheter aortic valve implantation: predictors and prognosis

Abstract Background The importance of concomitant tricuspid regurgitation (TR) in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) remains unclear. Objectives To document the prevalence of concomitant TR before and after TAVI, to correlate TR severity after TAVI with clinical outcome, to quantify suitability for transcatheter tricuspid valve interventions (TTVI), and to report clinical outcome in patients eligible for TTVI. Methods In a prospective TAVI registry, the severity of TR at baseline and after TAVI was retrospectively evaluated. Results Among 2,008 eligible patients, 1,659 patients (82.6%) had ≤mild TR, 242 (12.1%) had moderate TR, 57 (2.8%) had severe TR, and 50 (2.5%) had massive TR. More than half of all patients with ≥moderate TR had an improvement of TR severity after TAVI. In contrast to baseline TR, >moderate TR after TAVI was associated with an increased risk of mortality (HRadjusted 1.89; 95% CI 1.03–3.46, HRadjusted 2.11; 95% CI 1.07–4.16, respectively) compared with ≤mild TR. After TAVI, 30 out of 101 patients with baseline ≥severe TR (29.7%) were deemed suitable candidates for TTVI. They had a 2-fold increased risk of mortality between 30 days and 1 year (HRadjusted: 1.97; 95% CI: 1.17–3.31) and a higher risk of persistent heart failure symptoms (RRadjusted: 2.75; 95% CI: 1.75–4.31). Conclusions Severity of TR improved in more than half of all patients after TAVI. More than moderate TR after TAVI was associated with a twofold increased risk of death at one year. Xx% of patients with relevant TR are anatomically suitable for TTVI. Funding Acknowledgement Type of funding sources: None. Figure 1

ESC/EACTS guidelines 2021 on the management of valvular heart diseases : What are the most important innovations?

In August 2021 the European Society for Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) updated their guidelines on the management of valvular heart disease. Since the publication of the previous version in 2017 new evidence regarding epidemiology, diagnosis and treatment of valvular heart diseases has been accumulating, which led to reassessment of several recommendations. Most importantly, the critical role of the heart team in treatment decision-making was reemphasized, the criteria for choosing the mode of aortic valve interventions were clarified, the definition of severe secondary mitral regurgitation was revised and the recommendation for transcatheter edge-to-edge mitral valve repair in patients with this condition was upgraded. Additionally, antithrombotic therapeutic regimens in patients with native valvular heart diseases and bioprostheses were reappraised, the indications for early surgery in selected asymptomatic patient groups were expanded and the potential of transcatheter tricuspid valve interventions in inoperable and high-risk patients was acknowledged, although the latter needs to be further evaluated. This review article summarizes the most important recommendations of the new guidelines.

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

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. The importance of concomitant TR in patients with severe aortic stenosis undergoing TAVR remains unclear. In a prospective TAVR registry, the severity of TR before and after TAVR was retrospectively evaluated in an echocardiography core laboratory. 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 30days 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). 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).

Imaging for transcatheter native tricuspid valve intervention: patient selection, procedural planning and interventional guidance.

There are an increasing number of transcatheter tricuspid valve interventions being performed worldwide using commercially available and investigational devices. Imaging in the pre-procedural and periprocedural period is essential for procedural and clinical success. Echocardiographic-based techniques are particularly important in these procedures, especially for interventional guidance. This review summarizes the current devices in use and how imaging is used for patient selection, procedural planning, and interventional guidance. The most commonly used method of transcatheter tricuspid intervention is edge-to-edge repair using the MitraClip or TriClip devices (Abbott, Santa Clara, CA, USA). Randomized controlled data is pending but observational studies have demonstrated success, especially in the setting of smaller coaptation gaps and adequate transesophageal imaging windows. Direct annuloplasty with the Cardioband (Edwards Lifesciences, Irvine, CA, USA) has also been used in many centers and has demonstrated success when the anatomy and mechanism of tricuspid regurgitation are appropriate for annuloplasty based on imaging evaluation. Lastly, transcatheter valve replacement is becoming more common using several investigational devices and relies heavily on imaging methods to achieve procedural success.

Right ventricle dysfunction assessment for transcatheter tricuspid valve repair: A matter of debate.

Newer approaches in transcatheter tricuspid valve replacement (TTVR) have recently showed optimistic data of efficacy and safety in patients at high risk for surgery. However, the absence of residual regurgitation (and subsequently higher likelihood for developing afterload mismatch) with TTVR compared with transcatheter tricuspid valve intervention may become a critical concern if RV dysfunction is misdiagnosed. Indeed, such sudden increase in afterload on the right ventricle (RV) may not be tolerable, resulting in higher risk of acute right heart failure in the early postoperative period. In this context, strain imaging may find a further application to provide a more comprehensive stratification of the severity of RV dysfunction and thus help to better define the eligibility criteria and timing for TTVR. Meanwhile, it is of paramount importance to underline the contribution given by the Trivalve study on the understanding of the role of RV function in TTVI, that so far was largely undefined, being evaluated only in small noncontrolled cohorts.

Roles of Cardiac Computed Tomography in Guiding Transcatheter Tricuspid Valve Interventions.

The field of transcatheter tricuspid valve interventions (TTVI) is rapidly evolving to meet a well-defined but unmet clinical need. Severe tricuspid regurgitation is common and is associated with significant morbidity and mortality. Surgical options are limited and of high risk. The success of TTVI depends on careful procedural planning, and cardiac computed tomography (CCT) plays an emerging key role. TTVI technologies have various targets, including the leaflets, annulus, and venae cavae, along with valve replacement. Based on the planned procedure, CCT allows for device sizing, careful assessment of the access route, and comprehensive analysis of relevant adjacent anatomic structures to enhance procedural safety. It can also evaluate right-sided heart function, and its data can be for fusion imaging and 3D printing. Procedural planning is key to TTVI's success and is highly dependent on high-quality CCT data. This review details the comprehensive roles of CCT, specifics of the dedicated TTVI protocol, and its limitations.

Transcatheter treatment of severe tricuspid regurgitation.

Severe tricuspid regurgitation is a commonly prevalent valvular heart disease that is an independent adverse prognostic marker. However, the majority of patients with tricuspid regurgitation are managed medically; isolated tricuspid valve surgery is rarely performed, partly owing to high associated in-hospital mortality. Therefore, several transcatheter tricuspid valve interventions (TTVIs) that have been developed over the last few years to address this unmet clinical need. The early experience with TTVI has shown that most devices can be safely implanted with excellent rates of technical success and acceptable safety outcomes. Most TTVI recipients have significant improvement in tricuspid regurgitation severity, functional class, and quality of life. Recent retrospective data also suggest mortality benefit of TTVI compared with medical management. There are several issues that need to be addressed prior to widespread adoption of TTVI, including more effective tricuspid regurgitation reduction and need for longer term efficacy data. TTVI has emerged as an attractive treatment option for management of high-risk patients with tricuspid regurgitation. In this review, we will discuss the anatomical considerations specific to tricuspid valve, patient selection, preprocedure planning, and summarize the current evidence and future perspectives on TTVI.

Outcomes of transcatheter tricuspid valve intervention by right ventricular function: a multicentre propensity-matched analysis.

Tricuspid regurgitation (TR) has a poor prognosis and limited treatment options and is frequently accompanied by right ventricular (RV) dysfunction. Transcatheter tricuspid valve interventions (TTVI) to reduce TR have been shown to be safe and feasible with encouraging early results. Patient selection for TTVI remains challenging, with the role of right ventricular (RV) function being unknown. The aims of this study were 1) to investigate survival in a TTVI-treated patient population and a conservatively treated TR population, and 2) to evaluate the outcome of TTVI as compared to conservative treatment stratified according to the degree of RV function. We studied 684 patients from the multicentre TriValve cohort (TTVI cohort) and compared them to 914 conservatively treated patients from two tertiary care centres. Propensity matching identified 213 pairs of patients with severe TR. As we observed a non-linear relationship of RV function and TTVI outcome, we stratified patients according to tricuspid annular plane systolic excursion (TAPSE) to preserved (TAPSE >17 mm), mid-range (TAPSE 13-17 mm) and reduced (TAPSE <13 mm) RV function. The primary outcome was one-year all-cause mortality. TTVI was associated with a survival benefit in patients with severe TR when compared to matched controls (one-year mortality rate: 13.1% vs 25.8%; p=0.031). Of the three RV subgroups, only in patients with mid-range RV function was TTVI associated with an improved survival (p log-rank 0.004). In these patients, procedural success was associated with a reduced hazard ratio for all-cause mortality (HR 0.22; 95% CI: 0.09, 0.57). TTVI is associated with reduced mortality compared to conservative therapy and might exert its highest treatment effect in patients with mid-range reduced RV function.

Transcatheter Tricuspid Valve Intervention: Current Perspective

Tricuspid regurgitation (TR) adversely impacts both quality of life and long-term survival, which generates interest in therapeutic approaches to mitigate these effects. Historically, therapeutic options for TR were limited to surgical approaches, which are often complicated by significant morbidity and mortality in elderly patients with multiple comorbidities. This gap in therapeutic options led to the rapid evolution of transcatheter tricuspid valve intervention (TTVI), with a wide variety of approaches pursued and early results suggesting that TTVI improves clinical outcomes. Numerous strategies, including edge-to-edge repair, annular reduction, spacers, caval valve implantation, and transcatheter tricuspid valve replacement form the basis of TTVI today. In this review, the authors discuss the current state of each approach.

Anatomical Similarities Between Mitral and Tricuspid Valves in Sheep, Ovis aries, Hearts

With the recent rapid growth in transcatheter mitral and tricuspid valve interventions, it has become increasingly important to understand detailed anatomy of the valves. In this study, we investigated the similarities, differences, and associations between the dimensions of the atrioventricular valves in a sheep model, as sheep heart valves have a similar morphology to human valves. A systematic dissection of twenty-five sheep hearts was performed, with annular circumference measurement, and sub-valvular anatomy documentation. There was a significant association (r=0.865; p=0.007) between the circumference of the mitral and tricuspid annuli. Authors also identified significantly more chordae tendinea in the subvalvular mitral apparatus compared to the tricuspid valve (15.8±1.2 vs. 13.9±1.5; p&lt;0.001). In conclusion, there is a significant association between the size of mitral and tricuspid valve annuli, and the morphology of leaflets and subvalvular apparatus is different between the two valves. These findings could have important implications in transcatheter device design, sizing, and optimal intervention timing.

Transcatheter Tricuspid Valve Intervention in Patients With Previous Left Valve Surgery

BackgroundScarce data exist on patients with previous left valve surgery (PLVS) undergoing transcatheter tricuspid valve intervention (TTVI). This study sought to investigate the procedural and early outcomes in patients with PLVS undergoing TTVI. MethodsThis was a subanalysis of the multicenter TriValve registry including 462 patients, 82 (18%) with PLVS. Data were analyzed according to the presence of PLVS in the overall cohort and in a propensity score–matched population including 51 and 115 patients with and without PLVS, respectively. ResultsPatients with PLVS were younger (72 ± 10 vs 78 ± 9 years; p < 0.01) and more frequently female (67.1% vs 53.2%; P = 0.02). Similar rates of procedural success (PLVS 80.5%; no-PLVS 82.1%; P = 0.73), and 30-day mortality (PLVS 2.4%, no-PLVS 3.4%; P = 0.99) were observed. After matching, there were no significant differences in both all-cause rehospitalisation (PLVS 21.1%, no-PLVS 26.5%; P = 0.60) and all-cause mortality (PLVS 9.8%, no-PLVS 6.7%; P = 0.58). At last follow-up (median 6 [interquartile range 1-12] months after the procedure), most patients (81.8%) in the PLVS group were in NYHA functional class I-II (P = 0.12 vs no-PLVS group), and TR grade was ≤ 2 in 82.6% of patients (P = 0.096 vs no-PVLS group). A poorer right ventricular function and previous heart failure hospitalization determined increased risks of procedural failure and poorer outcomes at follow-up, respectively. ConclusionsIn patients with PLVS, TTVI was associated with high rates of procedural success and low early mortality. However, about one-third of patients required rehospitalisation or died at midterm follow-up. These results would support TTVI as a reasonable alternative to redo surgery in patients with PLVS and suggest the importance of earlier treatment to improve clinical outcomes.

Update on Transcatheter Tricuspid Valve Replacement Therapies.

Severe tricuspid regurgitation is relatively common, especially in the elderly, and portends poor survival. Neither medical therapy nor conventional surgery is efficacious for most patients. In contrast, transcatheter tricuspid valve interventions are showing promise to improve quality of life and mortality. Although there is more clinical experience with transcatheter tricuspid valve repair, there are many patients for which repair is either not possible or cannot optimally reduce the severity of tricuspid regurgitation. Transcatheter tricuspid valve replacement is rapidly emerging and may ultimately become the preferred treatment option. In this review, we discuss transcatheter tricuspid valve replacement, analyze the devices in development and in clinical trials, and highlight the advantages and drawbacks of transcatheter tricuspid valve replacement vs. repair.

Transcatheter Tricuspid Valve Intervention in Patients With Right Ventricular Dysfunction or Pulmonary Hypertension: Insights From the TriValve Registry.

Scarce data exist on patients with right ventricular dysfunction (RVD) or pulmonary hypertension (PH) undergoing transcatheter tricuspid valve intervention. This study aimed to determine the early and midterm outcomes and the factors associated with mortality in this group of patients. This subanalysis of the multicenter TriValve (Transcatheter Tricuspid Valve Therapies) registry included 300 patients with severe tricuspid regurgitation with RVD (n=244), PH (n=127), or both (n=71) undergoing transcatheter tricuspid valve intervention. RVD was defined as a tricuspid annular plane systolic excursion <17 mm, and PH as an estimated pulmonary artery systolic pressure ≥50 mm Hg. Mean age of the patients was 77±9 years (54% women). Procedural success was 80.7%, and 9 patients (3%) died during the hospitalization. At a median follow-up of 6 (interquartile range, 2-12) months, 54 patients (18%) died, and the independent associated factors were higher gamma-glutamyl transferase values at baseline (hazard ratio, 1.02 for each increase of 10 u/L [95% CI, 1.002-1.04]), poorer renal function defined as an estimated glomerular filtration rate <45 mL/min (hazard ratio, 2.3 [95% CI, 1.22-4.33]), and the lack of procedural success (hazard ratio, 2.11 [95% CI, 1.17-3.81]). The grade of RVD and the amount of PH at baseline were not found to be predictors of mortality. Most patients alive at follow-up improved their functional class (New York Heart Association I-II in 66% versus 7% at baseline, P<0.001). In patients with severe tricuspid regurgitation and RVD/PH, transcatheter tricuspid valve intervention was associated with high procedural success and a relatively low in-hospital mortality, along with significant improvements in functional status. However, about 1 out of 5 patients died after a median follow-up of 6 months, with hepatic congestion, renal dysfunction, and the lack of procedural success determining an increased risk. These results may improve the clinical evaluation of transcatheter tricuspid valve intervention candidates and would suggest a closer follow-up in those at increased risk. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03416166.