Reduction Of Tricuspid Regurgitation Research Articles

Impact of Optimal Procedural Result After Transcatheter Edge-to-Edge Tricuspid Valve Repair: Results From TRI-SPA Registry.

Procedural success following tricuspid transcatheter edge-to-edge repair (TEER) has been defined variably over time; however, the consequences of achieving a tricuspid regurgitation (TR) grade of 0/1+ are still unclear. This study aimed to assess the predictors and prognostic impact of achieving TR 0/1+ after TEER and its role in clinical events. This multicenter registry included patients undergoing tricuspid TEER in 15 Spanish centers from June 2020 and May 2023. Patients were categorized into the following groups based on the TR grade after procedure: optimal (0/1+), acceptable (2+), and not acceptable (≥3+). The primary endpoint was the 1-year composite of all-cause death, heart failure hospitalization, and tricuspid reintervention. Secondary endpoints included each component of the primary endpoint assessed separately, NYHA functional class, and TR grade at follow-up. Among 280 enrolled patients, 120 (42.9%) had residual TR 0/1+, 111 (39.6%) had residual TR 2+, and 49 (17.5%) had residual TR≥3+. Patients with TR 0/1+ experienced lower rates of the primary endpoint (13% vs 20% vs 31%; log-rank P=0.036). Residual TR≥3+ was an independent predictor of primary endpoint (HR: 2.277; P = 0.044). Higher rates of NYHA functional class I or II and sustained TR reduction were seen in the TR 0/1+ group (P< 0.001 for both). A small coaptation gap and absence of septal leaflet tethering were independent predictors of achieving TR 0/1+. An optimal procedural result after TEER might be associated with improved outcomes. TR coaptation gap and leaflet restriction may aid in assessing suitability for TEER.

Edge-to-edge repair for tricuspid valve regurgitation: 1-year follow up and clinical implications from the TR- Interventional Study (TRIS)

Abstract Background Tricuspid regurgitation (TR) affects 7% of the population, contributing significantly to heart failure-related hospitalizations. Traditional treatments have several limitations, prompting the exploration of innovative interventions. Purpose The present study aims to investigate the efficacy of tricuspid valve transcatheter edge-to-edge repair (T-TEER) in real-world patients with severe and symptomatic TR deemed at high surgical risk. Primary objectives focus on assessing T-TEER-induced TR reduction and reverse structural remodeling of the RV. Secondary objectives include assessment of functional status, quality of life, and residual regurgitation during the 12-month follow-up period. Methods The TR-Interventional study (TRIS) is a prospective, single-arm study. From January 2021 to December 2023, we enrolled 44 symptomatic patients with at least severe TR referred for TEER. Outcomes included safety and effectiveness along with assessment of clinical status. Results The study cohort had a mean age of 78.3±7 years, with 77.3% women and a mean TRISCORE of 5.1±1.9. Seventeen patients (38.6%) had massive, 7 (15.9%) had torrential, and 20 (45.5%) patients had severe TR. Etiologies included functional (40.9%), degenerative (13.64%), lead-induced (15.9%), and mixed (29.54%) origin. The primary efficacy endpoint, which assesses the successful implantation and performance of the device at the 30-day mark, was attained in 82.9% of patients. The secondary efficacy endpoint, assessing the stability of TR reduction at the 12-month, was achieved in 82,3% of patients. Post-procedural TR reduction of at least 2 degrees was achieved in 84% of patients. Echocardiographic assessments indicate ongoing beneficial remodeling over the one-year follow-up (Figure 1). Effects on RV remodeling also became apparent at the one-year follow-up, including reductions in the RV end-diastolic basal (p&amp;lt;0.01) and medium (p= 0.04) diameters of the TA septal-lateral diameter (p&amp;lt; 0.01). Significant reduction in vena contracta width (9 mm to 3 mm; p=&amp;lt;0.01), regurgitant volume (58 ml to 30 ml; p&amp;lt;0.01), and effective regurgitant orifice area (EROA) (0.6 cm2 to 0.3 cm2; p&amp;lt;0.01), occurred between baseline and one-year follow-up (Figure 2). The NYHA Functional Class and KCCQ scores were improved from 30 days to 1 year (Figure 2). Conclusion TRIS suggests that T-TEER is a durable, effective, and safe therapeutic option for high-risk patients with severe TR. The enduring nature of TR reduction at one year correlates with sustained clinical benefits and reverse structural remodeling of the right ventricle.TR reductionNYHA and functional status

Residual tricuspid regurgitation after transcatheter tricuspid valve edge-to-edge repair: the EuroTR Registry

Abstract Background Data on the prognostic impact of residual tricuspid regurgitation (TR) after transcatheter tricuspid valve edge-to-edge repair (T-TEER) are scarce. Purpose The aim of this analysis was to evaluate two-year survival and symptomatic outcomes of patients in relation to residual TR after T-TEER. Methods Using the large European Registry of Transcatheter Repair for Tricuspid Regurgitation (EuroTR Registry) we investigated the impact of residual TR on two-year all-cause mortality and New York Heart Association (NYHA) functional class at follow-up. The study further identified predictors for residual TR ≥3+ using a logistic regression model. Results The study included a total of 1286 T-TEER patients (53.6% females, mean age 78.0 ± 8.9 years). TR was successfully reduced to ≤1+ in 42.4%, 2+ in 40.0% and 3+ in 14.9% of patients at discharge, while 2.8% remained with TR ≥4+ after the procedure. Residual TR ≥3+ was an independent multivariable predictor of two-year all-cause mortality (hazard ratio 2.06, confidence interval 1.30-3.26, p=0.002, Figure 1). The prevalence of residual TR ≥3+ was 4-times higher in patients with higher baseline TR (vena contracta &amp;gt; 11.1 mm) and more severe TV tenting (tenting area &amp;gt;1.92 cm2) (Figure 2). Of note, no survival difference was observed in patients with residual TR ≤1+ vs. 2+ (76.2% vs. 73.1%, p=0.461). The rate of NYHA functional class ≥ III at follow-up was significantly higher in patients with residual TR ≥3+ (52.4% vs. 40.5%, p&amp;lt;0.001). Of note, the degree of TR reduction significantly correlated with the extend of symptomatic improvement (p=0.012). Conclusions T-TEER effectively reduced TR severity in the majority of patients. While residual TR ≥3+ was associated with worse outcomes, no differences were observed for residual TR 1+ vs. 2+. Symptomatic improvement correlated with the degree of TR reduction.Figure 1- Residual TR after T-TEERFigure 2 - Predicting residual TR

Improvement of endorgan function following tricuspid edge-to-edge repair

Abstract Background/Introduction Subjects with severe tricuspid regurgitation (TR) often suffer from impaired endorgan function. The potential to improve endorgan function is an important goal of treatment. Purpose To assess baseline endorgan function and changes in organ function following transcatheter edge-to-edge repair with the TriClip device in subjects with severe TR from the TRILUMINATE Pivotal randomized controlled trial. Methods Right heart catheterization was required prior to enrollment; medication history was collected. Changes in biomarkers, including MELD-XI, GGT, eGFR, BUN, and TR and KCCQ overall summary score were assessed at baseline and 12-month follow-up for all enrolled subjects. A 15% improvement in biomarker levels was considered clinically relevant. The odds of achieving a 15% improvement in biomarkers between baseline and 12-month follow-up was compared between the Device and Control groups (presented as OR [95% CI]). Results A total of 572 subjects were enrolled and randomized. At baseline, subjects had elevated levels of GGT (83.0±87.7 U/L) and MELD-XI score (10.3±5.2), low eGFR (56.7±21.0 mL/min/1.73m2), and elevated BUN (29.5±16.7 mg/dL). Nearly 90% of subjects were on loop diuretics, with approximately 50% taking these in combination with a thiazide or potassium-sparing diuretic. The average diuretic dosage was 71 mg (furosemide equivalent). Most subjects had normal left ventricle ejection fraction (only 5% with LVEF &amp;lt;40%). Subjects had well-managed blood pressure (systolic: 122±13 mmHg, diastolic: 69±10), slightly elevated central venous pressures (12±6 mmHg), systolic pulmonary artery pressures (40±10 mmHg) and pulmonary capillary wedge pressures (15±4 mmHg), and normal transpulmonary gradients (11±4 mmHg). The odds of achieving a 15% improvement in liver and renal function was higher in TriClip patients compared to control: MELD-XI score (1.79 [1.22, 2.63]), GGT (1.83 [1.21, 2.77]), and eGFR (1.81 [1.18, 2.77]) - Fig 1. The favorable changes in organ function observed were also reflected when stratifying subjects by residual TR severity: The odds of a 15% biomarker improvement favored subjects with moderate or less residual TR for MELD-XI score (2.05 [1.39, 3.00]), GGT (1.91 [1.26, 2.90]), and eGFR (1.83 [1.20, 2.80]) compared with subjects who had severe or worse residual TR. Lastly, improvement in these biomarkers also favored subjects with a 15-point or greater improvement in KCCQ compared with subjects with less than a 15-point KCCQ improvement. Conclusions Use of TriClip in subjects with severe tricuspid regurgitation was associated with improvement in kidney and liver function, and this improvement was associated with reduction in the severity of TR. These data provide the first objective evidence of the physiologic impact of TR reduction obtained in a randomized clinical trial.

Transcatheter Valve Repair for TricuspidRegurgitation: 1-Year Results from a Large European Real-World Registry.

Tricuspid valve transcatheter edge-to-edge repair has emerged as a valuable treatment option for patients with severe tricuspid regurgitation (TR). This study aims to investigate the safety and effectiveness of the PASCAL transcatheter valve repair system in treating severe TR in a real-world patient population. The PASTE (PASCAL for Tricuspid Regurgitation-a European registry) study is an investigator-initiated, multicenter, retrospective, and prospective observational cohort analysis conducted across 16 European heart valve centers including consecutive patients treated with the PASCAL transcatheter valve repair system from February 2019 to November 2023. Echocardiographic assessments were performed at baseline, discharge, and follow-up, and were subjected to centralized analysis. The study included 1,059 high-risk patients (mean age 79 ± 9 years; 53% female; TRI-SCORE risk 23% ± 18%; 87% NYHA functional class III/IV) with multiple comorbidities. Severe or higher graded TR was observed in 96% of patients. Intraprocedural success according to Tricuspid Valve Academic Research Consortium criteria was achieved in 85%, and TR reduced to ≤moderate in 87%. Independent predictors for a postprocedure residual TR of >moderate were coaptation gaps≥8mm (OR: 1.67; 95%CI: 1.03-2.72; P=0.038), tenting height≥10mm (OR: 2.18; CI: 1.30-3.65; P=0.003), the presence of a transvalvular lead (OR: 1.91; 95% CI: 1.19-3.05; P=0.007), right ventricular dilatation >42mm (OR: 3.35; 95% CI: 1.37-9.1; P=0.009) and massive/torrential TR at baseline (OR: 4.59; 95% CI:2.35-8.96; P< 0.001). At 1 year, 83% of patients showed ≤moderate TR. Significant clinical improvements included enhanced NYHA functional class (66% class I/II vs 17% at baseline; P< 0.001). Patients treated with the first-generation PASCAL system (n = 570) and with the new PASCAL Precision system (n = 489) had similar clinical profiles and TR severity at baseline. However, the Precision cohort showed greater TR reduction to trace/mild (63% vs 49%; P< 0.001), shorter procedure times (median 93minutes [Q1-Q3: 69-130 minutes] vs 120minutes [Q1-Q3: 82-165 minutes]; P< 0.001), and higher clinical success rates according to the Tricuspid Valve Academic Research Consortium at 30days and 1 year (87% vs 81% [P=0.021] and 56% vs 50% [P=0.044], respectively). Higher center experience (≥21 patients/year) resulted in higher intraprocedural and clinical success. The PASCAL system effectively treats severe TR in high-risk patients, offering sustained TR reduction and significant clinical improvements at 1-year follow-up. (PASCAL for Tricuspid Regurgitation-a European registry [PASTE]; NCT05328284).

Effective tricuspid regurgitation reduction is associated with renal improvement and reduced heart failure hospitalization.

Several studies have demonstrated an association between tricuspid regurgitation (TR) and organ dysfunction including hepatic and renal insufficiency. Improvement of liver function following transcatheter edge-to-edge repair (T-TEER) has already been linked to reduction of venous congestion due to TR reduction. This study analyzes whether TR-reduction using T-TEER is also associated with improved renal function. The TRIC-ULM registry includes 92 selected patients undergoing T-TEER between March 2017 and May 2023. Estimated glomerular filtration rate (eGFR) improvement was evident in 53 patients (57%) at 3-months follow-up (FU) and defined by FU eGFR > baseline eGFR. Median age was 80 [interquartile range 75-83] years, pre- and postinterventional TR grades were 4 [3-5] and 1 [1-2], baseline eGFR was 36 [30-53] ml/min and New Yeark Heart Association (NYHA) IV was evident in 15% of patients. Multiple logistic regression analysis revealed TR vena contracta reduction (Odds ratio (OR) 1.35 [95% CI: 1.12-1.64] per mm, p = 0.002) and reduced preinterventional tricuspid annular plane systolic excursion (TAPSE) [OR 0.89 (95% CI: 0.79-0.99) per mm, p = 0.033] to independently predict renal improvement at FU. An eGFR improvement threshold of >9 ml/min was associated with reduced 1-year heart failure hospitalization rates [adjusted hazard ratio 0.22 (95% CI: 0.07-0.62) p = 0.005]. Effective tricuspid edge-to-edge repair is associated with improved renal function and reduced heart failure hospitalization. In patients without renal improvement at 3-months follow-up, residual tricuspid regurgitation should be reevaluated for reintervention.

Exercise testing in patients with tricuspid regurgitation undergoing transcatheter tricuspid valve intervention.

Transcatheter tricuspid valve intervention (TTVI) has shown promising results with persistent reduction of tricuspid regurgitation (TR) and improvements in functional class and quality of life (QOL). To analyze the impact of TTVI on maximal and submaximal exercise capacity (SEC). Constant work-rate exercise-time (CWRET) testing reflects SEC, which is more likely to be relevant for daily life activities and provides more differentiated physiological insight into the nature of exercise intolerance. Thus, 30 patients undergoing TTVI (21 direct annuloplasty and 9 edge-to-edge repair) received cardiopulmonary exercise testing (CPET) and CWRET (at 75% of maximum work rate in the initial CPET) before and 3months after TTVI. Patients' age was 80.5 [74.8-82.3] years and 53.3% were female. TR reduction ≥ 2 grades was achieved in 93.3% (TR grade ≤ moderate in 83.3%). Echocardiography revealed improved right ventricular (RV) characteristics with decreased RV basal diameter (47.0mm [43.0-54.3] vs. 41.5mm [36.8-48.0]; p < 0.001) and decreased inferior caval vein diameter. CWRET testing showed a significantly improved SEC (246.5s [153.8-416.8] vs. 338.5s [238.8-611.8] p = 0.001). Maximum oxygen uptake showed a positive trend without statistically significant differences (9.9ml/min/kg [8.6-12.4] vs. 11.7ml/min/kg [9.7-13.3]; p = 0.31). In contrast to the six-minute-walking distance (6MWD), SEC correlated moderately with effective regurgitation orifice area reduction (r = 0.385; p = 0.036), increased cardiac output (r = 0.378; p = 0.039), and improved QOL (r = 387; p = 0.035). Improvements in exercise capacity after TTVI mainly occur in the submaximal rather than in the maximal exercise range and correlate with hemodynamic effects and QOL. This may have a methodological impact on assessment of exercise capacity in these patients.

Tricuspid transcatheter edge-to-edge repair for severe tricuspid regurgitation: 1-year outcomes from the TRILUMINATE randomized cohort.

Tricuspid regurgitation (TR) is a right-sided valvular disease independently associated with morbidity and mortality. The TRILUMINATE Pivotal trial is the first randomized, controlled trial assessing the impact of TR reduction with tricuspid transcatheter edge-to-edge repair (T-TEER). Outcomes from the full randomized cohort of the TRILUMINATE Pivotal trial have not been previously reported, and the additional enrollment may further support the safety and effectiveness of T-TEER through 1 year. The TRILUMINATE Pivotal trial is an international RCT of T-TEER with the TriClip device in patients with symptomatic, severe TR. Adaptive trial design allowed enrollment past the primary analysis population. The primary outcome was a hierarchical composite of all-cause mortality or tricuspid valve surgery, heart failure hospitalizations (HFH), and quality-of-life improvement measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 1 year. Between August 21, 2019 and June 29, 2022, 572 subjects were randomized, including the primary cohort (n=350) and subsequent enrollment (n=222). Subjects were elderly (78.1±7.8 years) and predominantly female (58.9%), with atrial fibrillation (87.8%) and prior HFH (23.8%). The primary endpoint was met for the full cohort (win ratio=1.84, p<0.0001). Freedom from all-cause mortality and tricuspid valve surgery through 12 months was 90.6% and 89.9% for the device and control groups, respectively (p=0.82). Annualized HFH rate was comparable between device and control subjects (0.17 vs 0.20 events/patient-year, p=0.40). A significant treatment effect was observed for change in quality of life with 49.5% of device subjects achieving a ≥15-point KCCQ score improvement (compared to 25.6% of control subjects, p<0.0001). All secondary endpoints favored T-TEER: moderate or less TR at 30 days (88.9% vs 5.3%, p<0.0001), KCCQ change at 1 year (13.0±1.4 vs -0.5±1.4 points, p<0.0001), and six-minute walk distance change at 1 year (1.7±7.5 vs -27.4±7.4 meters, p<0.0001). Freedom from major adverse events was 98.9% for T-TEER (vs. performance goal: 90%, p<0.0001). TriClip was safe and effective in the full randomized cohort of TRILUMINATE Pivotal with significant TR reduction and improvements in six-minute walk distance and health status. Rates of all-cause mortality or TV surgery and HFH through 1 year were not reduced by T-TEER.

Impact of Pulmonary Hypertension on Outcomes After Transcatheter Tricuspid Valve Edge-to-Edge Repair

BackgroundData regarding the association of pulmonary hypertension (PH) and outcomes in patients undergoing transcatheter tricuspid valve edge-to-edge repair (T-TEER) are scarce. ObjectivesThe aims of this study were 1) to investigate the impact of PH on outcomes after T-TEER; and 2) to shed further light on the role of pre- and postcapillary PH in patients undergoing T-TEER for relevant tricuspid regurgitation (TR). MethodsThe study included patients from the EuroTR (European Registry of Transcatheter Repair for Tricuspid Regurgitation) registry (NCT06307262) who underwent T-TEER for relevant TR from 2016 until 2023 with available invasive evaluation of systolic pulmonary artery pressure (sPAP) using right heart catheterization. Study endpoints were procedural TR reduction, improvement in NYHA function class, and a combined endpoint of death or heart failure hospitalization (HFH) at 2 years. ResultsAmong a total of 1,230 patients (mean age 78.6 ± 7.0 years, 51.4% women), increasing sPAP was independently associated with increasing rates of 2-year death or HFH (HR: 1.027; 95% CI: 1.003-1.052; P = 0.030; median survival follow-up 343 days [Q1-Q3: 114-645 days]). No significant survival differences were observed for patients with pre- vs postcapillary PH. Sensitivity analysis revealed an sPAP value of 46 mm Hg as the optimized threshold for the prediction of death or HFH. Being observed in 526 patients (42.8%), elevated sPAP (>46 mm Hg) was associated with more severe heart failure symptoms at baseline and follow-up. Importantly, NYHA functional class significantly improved and TR severity was significantly reduced irrespective of PH. ConclusionsPH is an important outcome predictor in patients undergoing T-TEER for relevant TR. In contrast to previous studies, no significant differences were observed for patients with pre- and postcapillary PH in terms of survival free from HFH.

Robustness of tricuspid regurgitation reduction at 1year following edge-to-edge repair for primary tricuspid regurgitation.

Within recent years, transcatheter tricuspid edge-to-edge repair (T-TEER) has emerged as a safe and effective treatment option in patients with secondary tricuspid regurgitation (TR). However, for primary TR, data on the robustness and durability of TR reduction 1year following T-TEER is limited. All consecutive patients treated with T-TEER for TR at two high-volume centers between September 2018 and December 2022 were enrolled in a registry. Primary TR was defined as tricuspid valve (TV) prolapse or flail TV leaflets as assessed by pre- and peri-interventional transesophageal echocardiography (TEE). 201 patients were included in this analysis, of whom 27 (13.4%) were classified as primary TR and 174 (86.6%) as TR of secondary origin. All-cause mortality during 1-year follow-up was reached by 50 patients (24.9%) [primary: 7 (25.9%), secondary: 43 (24.7%)], and 151 (75.1%) completed follow-up with transthoracic echocardiography (TTE). Patients' median age was 80 (76-83) years, 112 (55.7%) were female and 181 (90.1%) reported a New-York heart association functional class (NYHA-FC) of III or IV. The remaining baseline clinical and echocardiographic parameters were comparable between the groups, but secondary TR patients had a significantly higher TRI-SCORE (5 (4-8) vs. 7 (5-14), P = 0.010). In both groups, an immediate reduction of TR-Grade post-intervention was observed. This reduction was sustained at follow-up with 80.0% of the primary TR patients classified as moderate or less and 61.8% of the secondary TR patients. This translated to a significant improvement of NHYA-FC in both groups. Kaplan-Meier analysis revealed no differences regarding rates for all-cause mortality between the groups (P < 0.99). T-TEER achieves a robust TR reduction in primary TR patients 1year after intervention with noninferior clinical results to treatment for secondary TR with regards to mortality, re-hospitalization, and NYHA-FC.

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

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. 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. 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.

Predictors of residual tricuspid regurgitation after interventional therapy: an automated deep-learning CT analysis

Computed tomography (CT) is used as a valuable tool for device selection for interventional therapy in tricuspid regurgitation (TR). We aimed to evaluate predictors of TR reduction using CT and automated deep learning algorithms. Patients with severe to torrential TR and CTs prior to either percutaneous annuloplasty (PA) or tricuspid transcatheter edge-to-edge repair (T-TEER) were enrolled. CTs were analyzed using automated deep learning algorithms to assess tricuspid valve anatomy, right heart morphology, and function. Outcome parameters comprised post-interventional TR ≤ 1 and all-cause mortality. 84 patients with T-TEER (n = 32) or PA treatment (n = 52) were enrolled. Patients with a post-interventional TR ≤ 1 presented lower tenting heights and smaller tenting angles compared to patients with a TR > 1. Tenting height showed the best accuracy for post-interventional TR > 1 with an AUC of 0.756 (95% CI 0.560–0.951) in the T-TEER and 0.658 (95% CI 0.501–0.815) in the PA group, consistent with a suggested threshold of 6.8 mm and 9.2 mm, respectively. Patients with a post-interventional TR ≤ 1 exhibited a mortality of 4% and those with a TR > 1 of 12% during a follow-up of 331 ± 300 and 370 ± 265 days, respectively (p = 0.124). To conclude, tenting is associated with procedural outcomes and should be considered during screening for interventional TR therapy.

Transjugular Transcatheter Tricuspid Valve Replacement: Early Compassionate Use Outcomes

BackgroundData on procedural and early outcomes after transjugular transcatheter tricuspid valve replacement (TTVR) are limited. ObjectivesThis study sought to evaluate first-in-man procedural and clinical outcomes after transjugular TTVR with a special focus on patients who received large device sizes in whom TTVR outcomes have been questioned. MethodsThe retrospective registry included patients who underwent TTVR using the LuX-Valve Plus system (Jenscare Biotechnology Co Ltd) for symptomatic tricuspid regurgitation (TR) from January 2022 until February 2024 at 15 international centers in a compassionate use setting. The endpoints were procedural TR reduction, in-hospital death, adverse events, and 1-month survival. We further stratified results according to the size of the implanted device (<55 vs ≥55 mm). ResultsThe registry included a total of 76 patients at a median age of 78 years (Q1-Q3: 72-83 years, 47.4% women). TR was reduced to ≤2+ and ≤1+ in 94.7% and 90.8% of patients (75.0% of patients received TTVR devices ≥55 mm) with well-sustained results at 1-month follow-up (TR ≤2+ in 95.0% and ≤1+ 86.8%). Residual TR was paravalvular in all cases. In-hospital death occurred in 4 patients (5.3%). Four patients (5.3%) underwent cardiac surgery during index hospitalization. Major in-hospital bleeding events occurred in 5 patients (6.6%). New in-hospital pacemaker implantation was required in 3.9% of patients in the overall cohort (5.7% in “pacemaker-naive” individuals). No cases of valve thrombosis, stroke, myocardial infarction, or pulmonary embolism were observed. At 1-month follow-up, survival was 94.4%, and NYHA functional class significantly improved. One further patient received a pacemaker, 1 further bleeding event occurred, and 2 patients underwent reintervention or surgery within the first 30 days after TTVR. No differences in procedural outcomes or adverse events were observed after stratification for valve size. ConclusionsTransjugular TTVR appears to be a safe and effective treatment option for patients with severe TR with comparable outcomes in very large tricuspid anatomies.

GLIDE Score: Scoring System for Prediction of Procedural Success in Tricuspid Valve Transcatheter Edge-to-Edge Repair

BackgroundTricuspid valve transcatheter edge-to-edge repair (T-TEER) is the most widely used transcatheter therapy to treat patients with tricuspid regurgitation (TR). ObjectivesThe aim of this study was to develop a simple anatomical score to predict procedural outcomes of T-TEER. MethodsAll patients (n = 168) who underwent T-TEER between January 2017 and November 2022 at 2 centers were included in the derivation cohort. Additionally, 126 patients from 2 separate institutions served as a validation cohort. T-TEER was performed using 2 commercially available technologies. Core laboratory assessment of procedural transesophageal echocardiograms was used to determine septolateral and anteroposterior coaptation gap, leaflet morphology, septal leaflet length and retraction, chordal structure density, tethering height, en face TR jet morphology and TR jet location, image quality, and the presence of intracardiac leads. A scoring system was derived using univariable and multivariable logistic regression. Endpoints assessed were immediate postprocedural TR reduction ≥2 grades and TR grade moderate or less. ResultsThe median age was 82 years (Q1-Q3: 78-84 years); 48% of patients were women; and patients presented with severe (55%), massive (36%), and torrential (8%) TR. Five variables (septolateral coaptation gap, chordal structure density, en face TR jet morphology, TR jet location, and image quality) were identified as best predicting procedural outcome and were incorporated in the GLIDE (Gap, Location, Image quality, density, en-face TR morphology) score (range 0-5). TR reduction ≥2 grades and TR grade moderate or less were observed in >90% of patients with GLIDE scores of 0 and 1 and in only 5.6% and 16.7% of those with GLIDE scores ≥4. The GLIDE score was then externally validated in a separate cohort (area under the curve: 0.77; 95% CI: 0.69-0.86). TR reduction significantly correlated with functional improvement assessed by NYHA functional class and 6-minute walk distance at 3 months. ConclusionsThe GLIDE score is a simple, 5-component score that is readily obtained during patient imaging and can predict successful T-TEER.

The safety of transesophageal echocardiography to guide transcatheter tricuspid valve edge‐to‐edge repair

AbstractBackgroundTransesophageal echocardiography (TEE) is primarily used to guide transcatheter structural heart interventions, such as tricuspid transcatheter edge‐to‐edge repair (TEER). Although TEE has a good safety profile, it is still an invasive imaging technique that may be associated with complications, especially when performed during long transcatheter procedures or on frail patients. The aim of this study was to assess TEE‐related complications during tricuspid TEER.MethodsThis is a prospective study enrolling 53 patients who underwent tricuspid TEER for severe tricuspid regurgitation (TR). TEE‐related complications were assessed clinically and divided into major (life‐threatening, major bleeding requiring transfusions or surgery, organ perforation, and persistent dysphagia) and minor (perioral hypesthesia, &lt; 24 h dysphagia/odynophagia, minor intraoral bleeding and hematemesis not requiring transfusion)ResultsThe median age of the patient population was 79 years; 43.4% had severe, 39.6% massive, and 17.6% torrential TR. 62.3% of patients suffered from upper gastrointestinal disorders. Acute procedural success (APS) was achieved in 88.7% in a median device time of 36 min. A negative association was shown between APS and lead‐induced etiology (r = ‐.284, p = .040), baseline TR grade (r = ‐.410, p = .002), suboptimal TEE view (r = ‐.349, p = .012), device time (r = ‐.234, p = .043), and leaflet detachment (r = ‐.496, p &lt; .0001). We did not observe any clinical manifest major or minor TEE‐related complications during the hospitalization.ConclusionsOur study reinforces the good safety profile and efficacy of TEE guidance during tricuspid TEER. Adequate preoperative management and intraprocedural precautions are mandatory in order to avoid serious complications. Furthermore, suboptimal intraprocedural TEE views are associated with lower TR reduction rates.Highlights Transesophageal echocardiography is a crucial and safe technique for guiding transcatheter structural heart interventions. A mix of mid/deep esophageal and trans gastric views, as well as real‐time 3D imaging is generally used to guide the procedure. Adequate preoperative management and intraprocedural precautions are mandatory in order to avoid serious problems. A shorter device time is associated with more rarely probe‐related complications. Suboptimal intraprocedural TEE views are associated with lower TR reduction rates.

First-in-man Experience of a New Transcatheter Edge-to-edge Repair System Neoblazar in Patients With Severe Tricuspid Regurgitation

Objective: Severe tricuspid regurgitation frequently leads to increased mortality and a poor prognosis. Transcatheter edge-to-edge repair (TEER) for tricuspid valve regurgitation has been reported as a safe alternative to traditional open-heart surgery. This study endeavors to assess the efficacy and safety of a newly designed Neoblazar TEER system in this high-risk population. Methods: This investigation was structured as a prospective, single-arm, first-in-man trial in China (ClinicalTrials.gov number: NCT05497141). From August 2022 to October 2022, patients with severe tricuspid regurgitation were enrolled from 3 centers (Xiamen Cardiovascular Hospital, Fuwai Yunnan Cardiovascular Hospital, and Wuhan Union Hospital). The primary endpoint was achieving a minimum 1-grade reduction in tricuspid regurgitation at the 6-month post-TEER intervention, in addition to the pertinent New York Heart Association class. Scheduled echocardiographic evaluations were conducted at the following distinct intervals: baseline, discharge, 1 month, and 6 months post-TEER intervention. Results: A total of 10 patients were enrolled in the study. Immediately after the TEER procedure with the Neoblazar system, massive tricuspid regurgitation (grade 5+) at baseline decreased to moderate-severe tricuspid regurgitation (grade 3+) in 2 patients and the optimal tricuspid regurgitation reduction (severe tricuspid regurgitation (grade 4+) to mild tricuspid regurgitation (grade 1+)) were achieved in 6 patients. After 6 months of follow-up, tricuspid regurgitation reduction was found to be durable in all enrolled patients, among whom at least 1 grade of tricuspid regurgitation reduction was sustained, even without reintervention. Consistently, the New York Heart Association class among these subjects significantly improved, with the percentage of patients categorized as class I–II increasing from 0/10 at baseline to 5/10 after 1 month (P = 0.015) and 8/10 after 6 months (P &lt; 0.001). Conclusion: Tricuspid TEER with the newly designed Neoblazar system appears to be a feasible and safe alternative in treating patients with severe tricuspid regurgitation. However, the implementation of larger and more robust randomized trials is still necessary for further verification of the potential benefits.

Residual tricuspid regurgitation after tricuspid transcatheter edge-to-edge repair: Insights into the EuroTR registry.

Data on the prognostic impact of residual tricuspid regurgitation (TR) after tricuspid transcatheter edge-to-edge repair (T-TEER) are scarce. The aim of this analysis was to evaluate 2-year survival and symptomatic outcomes of patients in relation to residual TR after T-TEER. Using the large European Registry of Transcatheter Repair for Tricuspid Regurgitation (EuroTR registry) we investigated the impact of residual TR on 2-year all-cause mortality and New York Heart Association (NYHA) functional class at follow-up. The study further identified predictors for residual TR ≥3+ using a logistic regression model. The study included a total of 1286 T-TEER patients (mean age 78.0 ± 8.9 years, 53.6% female). TR was successfully reduced to ≤1+ in 42.4%, 2+ in 40.0% and 3+ in 14.9% of patients at discharge, while 2.8% remained with TR ≥4+ after the procedure. Residual TR ≥3+ was an independent multivariable predictor of 2-year all-cause mortality (hazard ratio 2.06, 95% confidence interval 1.30-3.26, p = 0.002). The prevalence of residual TR ≥3+ was four times higher in patients with higher baseline TR (vena contracta >11.1 mm) and more severe tricuspid valve tenting (tenting area >1.92 cm2). Of note, no survival difference was observed in patients with residual TR ≤1+ versus 2+ (76.2% vs. 73.1%, p = 0.461). The rate of NYHA functional class ≥III at follow-up was significantly higher in patients with residual TR ≥3+ (52.4% vs. 40.5%, p < 0.001). Of note, the degree of TR reduction significantly correlated with the extent of symptomatic improvement (p = 0.012). T-TEER effectively reduced TR severity in the majority of patients. While residual TR ≥3+ was associated with worse outcomes, no differences were observed for residual TR 1+ versus 2+. Symptomatic improvement correlated with the degree of TR reduction.

PERCUTANEOUS CORRECTION OF "BADLY ACCOMPANIED" MASSIVE TRICUSPID REGURGITATION

Abstract Background Tricuspid regurgitation (TR) is a common valvular pathology that impairs quality of life and survival. Tricuspid transcatheter edge–to–edge repair (t–TEER) has shown promising potential in the TR treatment. There remains several uncertainties such as timing of intervention in relation to clinical status, RV function, pulmonary artery pressure and many comorbidities that are often overlooked. Case Summary A 80–year–old man with dilated cardiomyopathy, persistent atrial fibrillation and biventricular defibrillator (ICD), was admitted to our centre for congestive heart failure (CHF). Echocardiography showed massive TR, severe right heart dilatation, increased systolic pulmonary artery pressure, severely dilated inferior vena cava (IVC) and hepatic veins with systolic flow reversal. We also found an uncommonly high blood flow coming to the right atrium from the IVC, due to an anomalous vascular communication between an intrahepatic portal branch and a hepatic vein, a so–called intrahepatic portosystemic venous shunt (IPSVS). Although these relatively rare shunts are usually not treated unless symptomatic, after a collective careful evaluation, we decided to proceed to the embolization of the IPSVS with a vascular plug, to make the t–TEER less challenging, safer and more durable. In better general conditions, after 2 months, the patient underwent the transcatheter tricuspid procedure with a single XTW TriClip™ (Abbott). At 3 months follow–up, the patient showed noticeable improvements in QoL, CHF signs and symptoms, echocardiographic parameters and exercise capacity. Discussion Appropriate timing of t–TEER is crucial not only to avoid irreversible RV damage and organ failure, but also to increase the success rate of the procedures. In this case we observed that the IPSVS treatment contributed significatively to improve the patient’s clinical status and to reduce the right heart volume overload before attempting the t–TEER. This combined approach facilitated the technical success of tricuspid procedure, that was itself challenging due to the ICD leads in the right chambers. Conclusion Patients’ selection and timing of percutaneous TR treatment are not clearly defined. This case shows that a winning strategy to approach challenging TR is to solve, before the tricuspid treatment, all the potentially treatable comorbidities that could negatively interfere with the technical success of the procedure itself and with the durability of TR reduction.

Real-World 1-Year Results of Tricuspid Edge-to-Edge Repair From the bRIGHT Study

BackgroundSevere tricuspid regurgitation (TR) is known to be associated with poor quality of life and increased risk of death when left untreated. ObjectivesWe sought to report the 1-year clinical outcomes of subjects treated by tricuspid transcatheter edge-to-edge repair (TEER) with the TriClip system (Abbott Cardiovascular) in a contemporary real-world setting. MethodsThe bRIGHT (An Observational Real-World Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip Device) postapproval study is a prospective, single-arm, open-label, multicenter postmarket registry conducted at 26 sites in Europe, with central event adjudication and echocardiographic core-laboratory assessment. ResultsEnrolled subjects (n = 511) were elderly (79 ± 7 years) with significant comorbidities. A total of 88% had baseline massive or torrential TR, and 80% of subjects were in NYHA functional class III/IV. TR was reduced to moderate or less in 81% at 1 year. Significant improvements in NYHA functional class (21% to 75% I/II, P < 0.0001) and Kansas City Cardiomyopathy Questionnaire (KCCQ) score (19 ± 26-point improvement, P <0.0001) were observed at 1 year. One-year mortality was significantly lower in subjects who achieved moderate or lower TR at 30 days; however, there was no difference in mortality among subjects who achieved moderate, mild, or trace TR at 30 days. In addition to TR reduction at 30 days, baseline serum creatinine and baseline right ventricular tricuspid annular plane systolic excursion (RV TAPSE) were independently associated with mortality at 1 year (OR: 2.169; 95% CI: 1.494-3.147; P < 0.0001; OR: 0.636; 95% CI: 0.415-0.974; P = 0.0375). Mortality was not associated with baseline TR grade or with center volume. ConclusionsTricuspid TEER using the TriClip system was safe and effective through 1 year for subjects with significant TR and advanced disease in a diverse real-world population. (An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip Device [bRIGHT]; NCT04483089)

Personalized Guidance of Edge-to-Edge Transcatheter Tricuspid Valve Repair by Multimodality Imaging.

Background: Transcatheter edge-to-edge tricuspid valve repair (T-TEER) for tricuspid regurgitation (TR) is always guided by transesophageal echocardiography (TEE). As each patient has unique anatomy and acoustic window, adding transthoracic echocardiography (TTE) and cardiac CT could improve procedural planning and guidance. Objectives: We aimed to assess T-TEER success and outcomes of a personalized guidance approach, based on multimodality imaging (MMI) of patient-tailored four right-sided chamber views (four-right-ch), as depicted by CT, TTE, TEE and fluoroscopy. Methods: Patients were assigned to MMI or classical TEE guidance, depending on TTE acoustic window. In MMI patients, planning included cardiac CT, which determined the fluoroscopic angulations of the specific four-right-ch, while guidance relied heavily on TTE, with minimal intermittent TEE for leaflet grasping and result confirmation. Both TTE and TEE were matched to respective CT and fluoroscopy four-right-ch. TR severity and quality of life (QoL) parameters were assessed from baseline to 12 months. Results: A total of 40 T-TEER patients were included, with 17 procedures guided by MMI and 23 solely by TEE. Baseline characteristics were similar between groups, e.g., age (83.1 ± 4.1 vs. 81 ± 5.3, p = 0.182) or STS-Score (11.1 ± 7.4% vs. 10.6 ± 5.9%, p = 0.813). The primary efficacy endpoint of ≥one-grade TR reduction at 30 days was 94% (16/17) in MMI vs. 91% (21/23) in TEE patients, with two or more TR grade reduction in 65% vs. 52% (p = 0.793). Device success was overall 100%, with no device-related complications, but three TEE-associated cases of gastrointestinal bleeding in the TEE-only group. By 12 months, all 15 MMI and 19 TEE survivors improved NYHA functional class and QoL, e.g., Kansas City Cardiomyopathy Questionnaire Score Δ29.6 ± 6.7 vs. 21.9 ± 5.8 (p = 0.441) pts., 6-min walk distance Δ101.5 ± 36.4 vs. 85.7 ± 32.1 (p = 0.541) meters. Conclusions: In a subset of patients with good TTE acoustic window, MMI guidance of T-TEER is effective and seems to avoid gastroesophageal injuries caused by TEE probe manipulation. TR reduction, irrespective of guidance method, impacts long-term QoL.