Transcatheter Tricuspid Valve Intervention Research Articles

Advances in Clinical Cardiology 2023: A Summary of Key Clinical Trials.

Over the course of 2023, 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. The authors collated and reviewed clinical trials presented at major cardiology conferences during 2023 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. A total of 80 key cardiology clinical trials were identified for inclusion. Key trials in acute coronary syndrome (ACS) and antiplatelet management such as HOST-IDEA, T-PASS and STOP-DAPT3 were included in addition to several pivotal interventional trials such as ORBITA 2, MULTISTARS-AMI, ILUMIEN-IV, OCTIVUS and OCTOBER. Additionally, several trials evaluated new stent design and technology such as BIOSTEMI, PARTHENOPE and TRANSFORM. Structural intervention trials included long-term data from PARTNER 3, new data on the durability of transcatheter aortic valve intervention (TAVI), in addition to major new trials regarding transcatheter tricuspid valve intervention from TRISCEND II. Heart failure (HF) and prevention covered several key studies including DAPA-MI, STEP-HF, ADVOR, DICTATE HF and CAMEO-DAPA. In cardiac devices and electrophysiology, several trial exploring novel ablation strategies in atrial fibrillation (AF) such as PULSED AF and ADVENT were presented with further data evaluating the efficacy of anticoagulation in subclinical AF in NOAH-AFNET 6, FRAIL AF and AZALEA-TIMI 71. 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.

Congestion patterns in severe tricuspid regurgitation and transcatheter treatment: Insights from a multicentre registry.

While invasively determined congestion holds mechanistic and prognostic significance in acute heart failure (HF), its role in patients with tricuspid regurgitation (TR)-related right- heart failure (HF) undergoing transcatheter tricuspid valve intervention (TTVI) is less well established. A comprehensive understanding of congestion patterns might aid in procedural planning, risk stratification, and the identification of patients who may benefit from adjunctive therapies before undergoing TTVI. The aim of this study was to investigate the role of congestion patterns in patients with severe TR and its implications for TTVI. Within a multicentre, international TTVI registry, 813 patients underwent right heart catheterization (RHC) prior to TTVI and were followed up to 24 months. The median age was 80 (interquartile range 76-83) years and 54% were women. Both mean right atrial pressure (RAP) and pulmonary capillary wedge pressure (PCWP) were associated with 2-year mortality on Cox regression analyses with Youden index-derived cut-offs of 17 mmHg and 19 mmHg, respectively (p < 0.01 for all). However, RAP emerged as an independent predictor of outcomes following multivariable adjustments. Pre-interventionally, 42% of patients were classified as euvolaemic (RAP <17 mmHg, PCWP <19 mmHg), 23% as having left-sided congestion (RAP <17 mmHg, PCWP ≥19 mmHg), 8% as right-sided congestion (RAP ≥17 mmHg, PCWP <19 mmHg), and 27% as bilateral congestion (RAP ≥17 mmHg, PCWP ≥19 mmHg). Patients with right-sided or bilateral congestion had the lowest procedural success rates and shortest survival times. Congestion patterns allowed for discerning specific patient's physiology and specifying prognostic implications of right ventricular to pulmonary artery coupling surrogates. In this large cohort of invasively characterized patients undergoing TTVI, congestion patterns involving right-sided congestion were associated with low procedural success and higher mortality rates after TTVI. Whether pre-interventional reduction of right-sided congestion can improve outcomes after TTVI should be established in dedicated studies.

Causes and Clinical Outcomes of Patients Who Failed Screening for Transcatheter Tricuspid Valve Interventions

Transcatheter tricuspid valve intervention (TTVI) has recently emerged as a promising alternative to surgery for tricuspid regurgitation (TR). However, a significant proportion of patients fail screening for TTVI, and little is known about their characteristics and natural history. This study sought to investigate causes of screen failure and outcomes of patients declined for TTVI. This was a retrospective single-center study of 32 patients who were ineligible for participation in transcatheter tricuspid valve replacement and tricuspid transcatheter edge-to-edge repair trials. Patients were classified into 2 groups according to the therapy they received: optimized medical therapy (OMT) group or intervention group. The mean age was 82 ± 7.8 years and 68.8% were women. The most common reasons for TTVI exclusion were anatomic/procedural impediment (53.1%), inclusion criteria not met (40.6%), and multivalvular disease (6.3%). Overall, 19 patients (59.4%) did not undergo subsequent tricuspid intervention. The clinical outcomes of these patients who received OMT alone were poor, with a 1-year composite of cardiac death or heart failure readmission of 47.4%. These rates were worse than in patients who subsequently underwent an intervention, albeit not statistically significant (OMT: 47.7% vs 23.1% interventions, p = 0.3), and were significantly more pronounced in the subgroup of patients who were excluded for anatomic/procedural limitations (OMT: 70% vs 14.3% interventions, p = 0.05). In conclusion, patients ineligible for TTVI, particularly, those with anatomic/procedural limitations, and treated medically have poor outcomes. These data underscore the importance of earlier referral and support the need for further transcatheter therapy iterations.

Pacing and Defibrillation Consideration in the Era of Transcatheter Tricuspid Valve Replacement.

Tricuspid regurgitation is a commonly encountered valvular pathology in patients with trans-tricuspid pacing or implantable cardioverter-defibrillator leads. Transcatheter tricuspid valve interventions are increasingly performed in patients at high surgical risk. Implantation of these valves can lead to the "jailing" of a trans-tricuspid lead. This practice carries both short- and long-term risks of lead failure and subsequent infection without the ability to perform traditional transvenous lead extraction. Herein, this manuscript reviews available therapeutic options for lead management in patients undergoing transcatheter tricuspid valve interventions. The decision to jail a lead may be appropriate in certain high-risk cases, though extraction may be a better option in most cases given the variety of options for re-implant, including leadless pacemakers, valve-sparing systems, epicardial leads, leads placed directly through prosthetic valves, and the completely subcutaneous implantable-defibrillator. A growing number of patients meet the requirement for CIED implantation in the United States. A significant proportion of these patients will have tricuspid valve dysfunction, either related to or independent of their transvenous lead. As with any percutaneous intervention that has shown efficacy, the role of TTVI is also likely to increase as this therapy advances beyond the investigational phase. As such, the role of the heart team in the management of these patients will be increasingly critical in the years to come, and in those patients that have pre-existing CIED leads, we advocate for the involvement of an electrophysiologist in the heart team.

Etiologies and Impact of Exclusion Rates for Transcatheter Mitral and Tricuspid Valve Structural Heart Clinical Trials at a High-Volume Quaternary Care Hospital

There are various devices under clinical investigation for transcatheter mitral valve intervention (TMVI) and tricuspid valve intervention (TTVI), but exclusion rates remain high. We aim to investigate exclusion rates for transcatheter mitral valve repair (TMVr), transcatheter mitral valve replacement (TMVR), transcatheter tricuspid valve repair (TTVr) and transcatheter tricuspid valve replacement (TTVR). There were a total of 129 patients who were referred to St. Francis Hospital & Heart Center valve clinic and completed screening between January 2021 and July 2022. Causes for exclusion were classified into 4 categories: patient withdrawal, anatomic unsuitability, clinical criteria and medical futility. Among 129 patients, the exclusion rates for TMVr, TMVR, TTVr and TTVR were 81%, 85%, 91% and 87%, respectively. Patient withdrawal and medical futility were leading etiologies for exclusion, followed by anatomical unsuitability. TMVr had the highest rate of patient withdrawal (64%), the lowest anatomic unsuitability (5%) due to short posterior leaflet length. Replacement interventions have higher anatomic unsuitability (33%) compared to repair interventions (17%) (p=0.04). Most exclusions of anatomic unsuitability was due to mitral stenosis or small annulus size for TMVR and large annulus size for TTVR. Fifty percent of exclusions from TTVr were due to presence of pacemaker/defibrillator leads. Among patients excluded from their respective trials, patients being referred for TMVr had the highest recurrent hospitalization and repair group had a higher mortality (p<0.01 and p=0.01, respectively). In conclusion, exclusion rates for TMVI and TTVI trials remain high due to various reasons, limiting patients’ enrollment and treatment. This supports the need for further device improvement or exploring alternative means of therapy.

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

AimsT-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 resultsThe 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. ConclusionsIn almost two third of patients T-TEER reduces TA diameter in addition to leaflet approximation. Condensed abstractThe 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.

Most hospitalized patients with significant tricuspid regurgitation have advanced disease preventing transcatheter tricuspid valve intervention

BackgroundMore than moderate tricuspid regurgitation (TR) is associated with high mortality. Surgical tricuspid valve repair and replacements are rarely performed due to high operative mortality risk, mainly attributed to late presentation. Novel transcatheter tricuspid valve intervention (TTVI) devices are being developed as an alternative to surgery. The population of patients presenting to tertiary care centers who can benefit from TTVI has not been well defined. MethodsWe retrospectively analyzed 12,677 consecutive 2D echocardiograms completed at our tertiary care center between March 2021 and March 2022 and identified hospitalized patients with more than moderate TR. A total of 569 patients were included in this study. Clinical and echocardiographic data were collected by individual chart review. We used the European Society of Cardiology (ESC) guidelines on the management of valvular disease to retrospectively assign patients to medical, surgical, or transcatheter therapy. Results458 patients (80.5 %) were assigned to medical therapy, 57 (10.0 %) were assigned to TTVI, and 54 (9.5 %) were assigned to tricuspid valve surgery. Of note, 75.7 % (431/569) of patients were precluded from any intervention due to advanced disease, and only 4.7 % (27/569) presented too early for intervention, being both asymptomatic and without RV dilatation. ConclusionOnly 10.0 % of patients presenting to a tertiary care center with significant TR would be candidates for TTVI when these technologies are approved in the United States. Earlier identification and treatment of TR could increase the number of patients who may benefit from interventions including TTVI.

Comparison of Tricuspid Annular Dimension Measurements Using Automated Three-Dimensional Transthoracic Echocardiography and Computed Tomography in Patients Evaluated for Transcatheter Tricuspid Valve Intervention

Comparison of Tricuspid Annular Dimension Measurements Using Automated Three-Dimensional Transthoracic Echocardiography and Computed Tomography in Patients Evaluated for Transcatheter Tricuspid Valve Intervention

Transcatheter Tricuspid Valve Intervention: Our Experience and the Current Status in the US

Transcatheter Tricuspid Valve Intervention: Our Experience and the Current Status in the US

Computed Tomography Planning for Transcatheter Tricuspid Valve Interventions

Computed Tomography Planning for Transcatheter Tricuspid Valve Interventions

Early deterioration of right ventricular strain in patients undergoing transcatheter tricuspid valve intervention

Abstract Background Severe tricuspid regurgitation (TR) leads to volume overload and increased wall stress causing detrimental right ventricular (RV) remodelling and dysfunction and is associated with excess mortality. Transcatheter tricuspid valve interventions (TTVI) emerged to treat patients with severe TR and high surgical risk, but predictors of outcome remain largely unknown. RV free wall longitudinal strain (RVFWLS) is a sensitive parameter for RV dysfunction and has shown prognostic value in patients with functional TR treated conservatively. Periinterventional changes in RVFWLS and right atrial (RA) strain have not been evaluated in patients undergoing TTVI. Purpose To analyse the effect of transcatheter tricuspid valve annuloplasty (TTVA) and transcatheter edge-to-edge repair (TEER) on RVFWLS and RA strain, assessed by speckle tracking echocardiography, and their association with outcome. Methods We retrospectively analysed consecutive patients with severe TR that underwent TTVI at our centre between 2020 and 2022. 126 patients were included (n=48 underwent TTVA with the Cardioband system, n=78 underwent TEER with the PASCAL system). Established parameters for RV function (TAPSE, FAC) as well as RVFWLS and RA reservoir strain (RASR) were analysed at baseline and one month after TTVI. Results All patients (median age 80 years, 69% female, 79% in NYHA III/IV functional class) were at prohibitive surgical risk. RV function at baseline was slightly reduced according to FAC (34% [29-39]) and preserved according to TAPSE (18mm [15-20]), whereas RVFWLS (-18.6±5.7%) and RASR (10.0% [7.0-14.0]) were severely reduced in markedly dilated right heart chambers (RV basal 45mm [41-49], RA area 34 cm2 [28-41]). TR reduction following TTVI to TR grade ≤ 2 was achieved in 77%. Right heart chamber size significantly decreased after one month (RV basal 41mm [38-45], RA area 29cm2 [25-38], P&amp;lt;0.001), with no improvement of FAC (37% [30-40], P=0.668) or RASR (10% [7-13], P=0.143) but deterioration of RV longitudinal function (TAPSE 17mm [13-20], P=0.002; RFWLS -16.1±5.7%, P=0.001) compared to baseline. RVFWLS reduction occurred irrespective of the procedure performed (TEER [-9.2±41.4] vs. TTVA [-7.0±31.3], P=0.783). RVFWLS deterioration occurred in 63%, whereas it improved in 37% of patients. Symptomatic and clinical outcome did not differ in patients with deteriorated vs. improved RVFWLS (improvement of at least one NYHA class 61.9% vs. 58.3%, P=0.569, one-year mortality 13.7% vs. 12.3%, P=0.940, one-year heart failure rehospitalization 10.8% vs. 17.1%, P=0.701). Conclusion Deterioration of RVFWLS after TTVI possibly reflects the decreased wall stress due to TR and consecutive preload reduction. However, symptomatic and clinical outcomes did not differ in patients with deteriorated RVFWLS vs. patients with improved RVFWLS. Reduction of RA size after TTVI did not translate into improvement of RASR, indicating an already advanced pre-existing RA dysfunction.

Transfemoral tricuspid valve replacement and one-year outcomes: the TRISCEND study.

For patients with symptomatic, severe tricuspid regurgitation (TR), early results of transcatheter tricuspid valve (TV) intervention studies have shown significant improvements in functional status and quality of life associated with right-heart reverse remodelling. Longer-term follow-up is needed to confirm sustained improvements in these outcomes. The prospective, single-arm, multicentre TRISCEND study enrolled 176 patients to evaluate the safety and performance of transcatheter TV replacement in patients with ≥moderate, symptomatic TR despite medical therapy. Major adverse events, reduction in TR grade and haemodynamic outcomes by echocardiography, and clinical, functional, and quality-of-life parameters are reported to one year. Enrolled patients were 71.0% female, mean age 78.7 years, 88.0% ≥ severe TR, and 75.4% New York Heart Association classes III-IV. Tricuspid regurgitation was reduced to ≤mild in 97.6% (P < .001), with increases in stroke volume (10.5 ± 16.8 mL, P < .001) and cardiac output (0.6 ± 1.2 L/min, P < .001). New York Heart Association class I or II was achieved in 93.3% (P < .001), Kansas City Cardiomyopathy Questionnaire score increased by 25.7 points (P < .001), and six-minute walk distance increased by 56.2 m (P < .001). All-cause mortality was 9.1%, and 10.2% of patients were hospitalized for heart failure. In an elderly, highly comorbid population with ≥moderate TR, patients receiving transfemoral EVOQUE transcatheter TV replacement had sustained TR reduction, significant increases in stroke volume and cardiac output, and high survival and low hospitalization rates with improved clinical, functional, and quality-of-life outcomes to one year. Funded by Edwards Lifesciences, TRISCEND ClinicalTrials.gov number, NCT04221490.

Right ventricular remodeling and clinical outcomes following transcatheter tricuspid valve intervention.

Characterize the impact of residual tricuspid regurgitation (TR) on right ventricle (RV) remodeling and clinical outcomes after transcatheter tricuspid valve intervention. We performed a single-center retrospective analysis of transcatheter tricuspid valve repair (TTVr) or replacement (TTVR) patients. The primary outcomes were longitudinal tricuspid annular plane systolic excursion (TAPSE), fractional area change (FAC), pulmonary artery systolic pressure (PASP), and RV dimensions (RVd). We used multivariable linear mixed models to evaluate association with replacement versus repair and degree of TR reduction with changes in these echo measures over time. Multivariable Cox regression was used to identify associations between changes in these echo measures and a composite clinical outcome of death, heart failure hospitalization, or re-do tricuspid valve intervention. We included a total of 61 patients; mean age was 77.5 ± 11.7 and 62% were female. TTVR was performed in 25 (41%) and TTVr in 36 (59%). Initially, 72% (n = 44) had ≤ severe TR and 28% (n = 17) had massive or torrential TR. The median number of follow up echos was 2: time to 1st follow-up was 50 days (interquartile range [IQR]: 20, 91) and last follow-up was 147 (IQR: 90, 327). Median TR reduction was 1 (IQR: 0, 2) versus 4 (IQR: 3, 6) grades in TTVr versus TTVR (p < 0.0001). In linear mixed modeling, TTVR was associated with decline in TAPSE and PASP, and TR reduction was associated with decreased RVd. In multivariable Cox regression, greater RVd was associated with the clinical outcome (hazard ratio: 9.27, 95% confidence interval: 1.23-69.88, p = 0.03). Greater TR reduction is achieved by TTVR versus TTVr, which is in turn associated with RV reverse remodeling. RV dimension in follow-up is associated with increased risk of a composite outcome of death, heart failure hospitalization, or re-do tricuspid valve intervention.

Lead management in patients undergoing percutaneous tricuspid valve replacement or repair: a 'heart team' approach.

Clinically significant tricuspid regurgitation (TR) has historically been managed with either medical therapy or surgical interventions. More recently, percutaneous trans-catheter tricuspid valve (TV) replacement and tricuspid trans-catheter edge-to-edge repair have emerged as alternative treatment modalities. Patients with cardiac implantable electronic devices (CIEDs) have an increased incidence of TR. Severe TR in this population can occur for multiple reasons but most often results from the interactions between the CIED lead and the TV apparatus. Management decisions in patients with CIED leads and clinically significant TR, who are undergoing evaluation for a percutaneous TV intervention, need careful consideration as a trans-venous lead extraction (TLE) may both worsen and improve TR severity. Furthermore, given the potential risks of 'jailing' a CIED lead at the time of a percutaneous TV intervention (lead fracture and risk of subsequent infections), consideration should be given to performing a TLE prior to a percutaneous TV intervention. The purpose of this 'state-of-the-art' review is to provide an overview of the causes of TR in patients with CIEDs, discuss the available therapeutic options for patients with TR and CIED leads, and advocate for including a lead management specialist as a member of the 'heart team' when making treatment decisions in patients TR and CIED leads.

Surgical outcomes of patients at prohibitive risk who are reconsidered for surgery

ObjectivesTranscatheter treatment of advanced mitral and tricuspid valve disease is largely limited to patients at prohibitive surgical risk, although many are not candidates for transcatheter treatment. Here, we describe surgical outcomes of patients at prohibitive risk who were ineligible for transcatheter therapies to guide surgeons in management of this unique population. MethodsPatients at prohibitive risk, defined per surgeon or cardiologist discretion, who were initially referred for a transcatheter mitral or tricuspid intervention in a multidisciplinary atrioventricular valve clinic, were identified from 2019 to 2022. Preoperative risk, operative outcomes, and long-term mortality were evaluated. ResultsA total of 337 patients at prohibitive risk were referred for evaluation in a multidisciplinary atrioventricular valve clinic. Of those, 161 underwent transcatheter therapy, 130 patients underwent continued medical management, and 45 were reevaluated and had high-risk surgery. Among surgical patients, 51% were women with a median age of 76 years (quartile 1-quartile 3, 65-81 years). Most patients presented in heart failure (83%; n = 37 out of 45), and 73% were in New York Heart Association functional class III or IV. Most patients (94%; n = 43) had a mitral valve intervention, of whom 56% (24 out of 43) had a mitral valve replacement. The 30-day mortality rate was 4% (2 out of 45) and major morbidity occurred in 33% (15 out of 45). By Kaplan-Meier analysis, 1-year survival was 86% ± 9%. ConclusionsSelect patients at prohibitive risk who were ineligible for transcatheter mitral or tricuspid valve intervention underwent surgery with overall low operative mortality and excellent 1-year survival. Patients a prohibitive risk whose anatomy is not amenable to transcatheter devices should be reconsidered for surgery.

Characterization of Screen Failures Among Patients Evaluated for Transcatheter Tricuspid Valve Repair (TriSelect-Study)

BackgroundTranscatheter tricuspid valve repair (TTVr) has significantly expanded treatment options for tricuspid regurgitation (TR). However, a sizeable proportion of patients are still declined for TTVr and little is known about their clinical characteristics and cardiac morphology. ObjectivesThis study sought to characterize patients who screen fail for TTVr with respect to their clinical characteristics and cardiac morphology. MethodsA total of 547 patients were evaluated for TTVr between January 2016 to December 2021 from 3 centers in the United States and Germany. Clinical records and echocardiographic studies were used to assess medical history and right ventricular (RV) and tricuspid valve (TV) characteristics. ResultsMedian age was 80 (IQR: 74-83) years and 60.0% were female. Over half (58.1%) were accepted for TTVr. Of those who were deemed unsuitable for TTVr (41.9%), the most common exclusion reasons were anatomical criteria (56.8%). In the regression analysis, RV and right atrial size, TV coaptation gap, and tethering area were identified as independent screen failure predictors. Other rejection reasons included clinical futility (17.9%), low symptom burden (12.7%), and technical limitations (12.7%). Most of the excluded patients (71.6%) were managed conservatively with medical therapy, while a small number either proceeded to TV surgery (22.3%) or subsequently became eligible for transcatheter tricuspid valve replacement in later available clinical trials in the United States (6.1%). ConclusionsThe majority of TTVr screen failure patients are excluded due to TV, right atrial, and RV enlargement. However, a significant proportion is excluded due to clinical futility. These identifiable anatomical and clinical characteristics emphasize the importance of earlier referral and intervention of TR and the need for continued innovation of Transcatheter tricuspid valve interventions.

Transcatheter Tricuspid Valve Interventions: A Triumph for Transcatheter Procedures?

Tricuspid regurgitation (TR) is a common valvular pathology, estimated to affect 1.6 million people in the United States alone. Even though guidelines recommend either medical therapy or surgical treatment for TR, the misconception of TR as a benign disease along with the high mortality rates of surgical intervention led to undertreating this disease and commonly describing it as a "forgotten" valve. Recently, the development of transcatheter interventions for TR show promising potential for use in the clinical setting. There are currently few approved and numerous tested percutaneously delivered devices, which can be categorized, based on their mechanism of action, to either valve repair or valve replacement procedures. Both procedures were tested in clinical trials and show an echocardiographic reduction in TR sustained for at least 1 year after the procedure, as well as symptom relief and functional improvement of the patients. Device selection should be personalized, taking into consideration the anatomy of each valve and the available options at each heart center. Moreover, appropriate patient selection and timing of the procedure are also crucial for the success of the procedure. In this review, we analyze the clinical trials available for all devices currently approved or tested, aiming to provide a comprehensive summary of the most recent evidence in the field of transcatheter TR interventions.

Prognostic value of right ventricular function in patients with severe tricuspid regurgitation undergoing tricuspid valve intervention

Abstract Funding Acknowledgements Type of funding sources: None. Background Indications and optimal timing of intervention for severe tricuspid regurgitation (TR) remain controversial due to insufficient evidence. Right ventricular (RV) function assessment, a key factor of preoperative evaluation, remains challenging due to limitations of conventional echocardiographic indexes, particularly with concomitant severe TR. Right ventricular free wall longitudinal strain (RVFWLS) is able to evaluate intrinsic systolic function and to identify RV dysfunction at early stage compared to conventional echocardiographic indices. Purpose to analyze the prognostic implications of pre-operative RV dysfunction, evaluated through conventional and speckle-tracking echocardiography, in patients with severe TR undergoing tricuspid valve intervention. Methods In this single-center retrospective study, we enrolled consecutive patients with severe TR who underwent surgical or transcatheter tricuspid valve intervention (TTVI) between November 2016 and July 2021. The primary endpoint was all-cause mortality. For a secondary exploratory analysis, to compare outcomes of operated versus conservatively treated patients, we enrolled consecutive patients with severe TR who underwent echocardiographic evaluation in the same time period and who undergo conservative management. Results Study population included 100 patients: 78 patients underwent isolated TV surgical intervention and 22 TTVI. ROC curve analysis showed RVFWLS as the best echocardiographic parameter to predict all-cause mortality (AUC: 0.726, IC 0.57–0.88 P = 0.006). Estimated 4-years survival was significantly lower in patients with RV dysfunction (defined as an absolute value of RVFWLS ≤ 21%, cutoff derived from ROC analysis with sensitivity 60% and specificity 87%) compared to patients with normal RV function: 70.0% vs 93.9% p = 0.002 (Figure 1). Independent prognostic role of RVFWLS was confirmed at multivariable analysis adjusted for significative clinical and echocardiographic variables (OR 0.88, 95% CI 0.80–0.98; P = 0.016). At secondary exploratory analysis, patients treated conservatively had a worst estimated 4-year survival compared to operated patients (59.6% vs 84.0%, p = 0.001). Stratifying this population according to the presence of RV dysfunction, in the group with lower RVFWLS values there were no significative differences in overall survival between operated and conservatively-treated patients (Figure 2). Conclusions Preoperative RV dysfunction defined by echocardiographic strain analysis is independently associated with outcomes after TV intervention. RVFWLS could be useful for indication and timing of intervention for severe TR.

Accuracy of the simple 3D transthoracic echocardiography in the definition of tricuspid valve and right ventricle anatomy

Abstract Funding Acknowledgements Type of funding sources: None. Introduction The interest in the "forgotten" valve has re-emerged in recent years in consideration of the high mortality rate related to the highest degrees of TR and the recognition of a large amount of patients who remains under treated. Transcatheter tricuspid valve interventions (TTVI) represent a valuable option in high risk surgical candidates when specific anatomic criteria are met. Tailoring the most suitable therapeutic percutaneous strategy for each patient is crucial: an accurate screening aims to quantify regurgitation grade and fully understand the underlying mechanism. Transthoracic and transesophageal is used to assess jet location, leaflets anatomy and motion. ECG-gated Cardiac TC is necessary for the selection of annuloplasty or replacement techniques. Purpose Aim of the study is to compare three different imaging modalities as 3D transthoracic echocardiography (TTE), transesophageal one (TOE) and ECG-gated Cardiac CT for the definition of tricuspid valve anatomy, annular dimensions and right ventricle geometry in patients screened for TTVI. Methods Twenty-one (Age 79 ± 7 years, Female 72%) patients, referred with a diagnosis of at least severe TR in evaluation for percutaneous treatment, were prospectively enrolled in the study and underwent TTE, TOE and Cardiac CT. All measurements were performed in double blind by three different operators and compared. Results In the comparison between 2D/3D TTE and 2D/3D TOE no statistically significant differences were found regarding the evaluation of the valve anatomy, the site of regurgitation and the underlying mechanism (TTE vs TOE: 3D septo-lateral diam 45,8± 4,92 vs 45,87 ± 4,98 mm, p = 0.87; 3D antero-posterior diam 43,5 ± 4,58 vs 43,5 ± 4,53 mm, p = 0.59; Circularity index 0,75± 0,08 vs 0,76± 0,08, p = 0.98; 3D Annular area 16,48±3.9 vs 15,97±3,75 cm2, p = 0.77; Annular perimeter 14,82±1,62 vs 14,93±1,9 cm, p = 0.54). From the double-blind comparison between 3D TTE and Cardio CT, no differences emerged regarding anatomic annulus parameters (area 17,58± 3 vs 17.71±4,3 cm2, p = 0.1; perimeter 14,89±1,6 vs 14,29±1 cm, p = 0.5; maximum diameter 50,5 ± 5 vs 50,6 ± 5.1mm, p = 0.19; minimum diameter 40,25±3.8 vs 41.16± 4,9mm, p = 0.28). Similarly, in the study of right ventricular dimensions, obtained through 3D volumetric reconstruction, TTE was not statistically different to Cardiac CT (3DTTE vs CT: RVD1 51,14 ±2,54 vs 49,42 ± 5 mm, p = 0.5; RVD2 40,62±7,9 vs 40±11 mm,p = 0.7; RVL 72, 12±7 vs 72,12±11 mm, p = 0.8). Conclusions Three-dimensional trans-thoracic echocardiography showed an optimal performance to define tricuspid valve anatomy and right ventricle dimensions when compared with other imaging methods. 3D TT can be safely used for an overall first line in periprocedural evaluation of patients candidates for TTVI, allowing for elaborated study of the characteristics of TR through MPR reconstructions, annular and valvular anatomy, right chambers size and function.

Tricuspid annulus remodelling after transcatheter edge-to-edge repair for reduction of tricuspid regurgitation

Abstract Funding Acknowledgements Type of funding sources: None. Background/Introduction Clinically relevant tricuspid regurgitation is a prevalent valvular disease that has a significant impact on survival. The remarkable progress made in cardiac imaging and in interventional cardiology in the last decades, permits today a better understanding of tricuspid valve and right ventricle morphology and pathophysiology. This allowed to develop multiple transcatheter devices for tricuspid valve interventions. Structural valve interventions are considered nowadays valuable treatment options in anatomically eligible patient at high surgical risk. Transcatheter tricuspid valve interventions are directed to increasing leaflet coaptation either directly by bringing the leaflets together (leaflet approximation devices) or indirectly by reducing the dilated annulus (annuloplasty devices). Efficacy and clinical outcome are promising, but the effect on right ventricle and tricuspid annular reverse remodelling is still under evaluation. Purpose Aim of the study is to evaluate the acute tricuspid annulus remodelling after percutaneous leaflet repair, using a leaflet approximation device for reduction of tricuspid regurgitation. Methods This is a retrospective dual-center cohort study that includes 22 consecutive patients, treated with TriClip in our Hospital. Tricuspid annulus geometry was evaluated using three-dimensional transoesophageal echocardiography examinations conducted during the procedure before and after Triclip implantation. The 3D data sets were analysed using the multiplanar reformatting method. Results The mean age of the study cohort was 80 years, and 90,9% were female. Tricuspid regurgitation was graded severe or greater at pre-operative examination in all patients, mostly due to annular dilation. Procedure was successfully in all patients, with at least 1-grade reduction of tricuspid regurgitation before hospital dismissal. A significative reduction of mean septal-lateral diameter (4,09 ± 0,45 cm vs 3,55 ± 0,57 cm, p = &amp;lt; 0,0001), mean major diameter (4,60 ± 0,56 cm vs 4,24 ± 0,58 cm, p = 0,0011), planimetric area (13,70 ± 2,68 cm2 vs 11,00 ± 2,49 cm2, p = &amp;lt;0,0001) and perimeter (13,50 ± 1,36 cm vs 12,40 ± 1,49 cm, p = 0,0001) of the tricuspid annulus was observed. The eccentricity index (obtained dividing septal-lateral by antero-posterior diameter) was 0,99±0,17 before TriClip implantation and 0,91± 0,19 after (p = 0,0336). Conclusions In this small real-world population, edge-to-edge repair using TriClip was found to be effective and safe. Tricuspid transcatheter repair with a leaflet approximation device lead also to a reduction in the tricuspidal annular dimensions. This is to date the first study that shows positive changes in tricuspid annular geometry, that could have potentially relevant therapeutic implications.