Reduction Of Tricuspid Regurgitation Research Articles

Tricuspid Regurgitation: A Review of Current Interventional Management.

Tricuspid regurgitation is a common yet clinically complex problem, traditionally managed with diuretic therapy with no observable mortality benefit. Older studies on surgical intervention observed poor outcomes; however, this clinical reasoning predates current surgical approaches and novel transcatheter technology. The tricuspid apparatus is a complex structure that poses a technical challenge for surgeons and interventional cardiologists. Recent advances in surgical techniques and transcatheter therapy, particularly edge-to-edge repair devices, have demonstrated promising results for safety, reduction in tricuspid regurgitation, and improving quality of life. We review the clinical, imaging, and hemodynamic findings that characterize patients who should be considered for intervention, alongside the rapidly evolving approaches to interventional management.

Characterization of Tricuspid Valve Anatomy and Coaptation Gap in Subjects Receiving Tricuspid Transcatheter Edge-To-Edge Repair: Observations From the bRIGHT TriClip Study

Transcatheter edge-to-edge repair (TEER) for the treatment of tricuspid regurgitation (TR) has experienced fast adoption following commercial approval. Defining the appropriate target population for TEER therapy is important to guide patient selection. The aim of this study was to characterize tricuspid valve anatomy and coaptation gap in subjects receiving TEER for the treatment of TR in a contemporary postmarket setting. The bRIGHT study is a prospective, multicenter, single-arm, postmarket study evaluating the safety and effectiveness of the TriClip device. Procedural outcomes included implant success, acute procedural success, TR severity, major adverse events, single-leaflet device attachment, and embolization through 30 postprocedure days. Tricuspid valve characteristics, including morphology, annulus size, and leaflet mobility, were assessed via two-dimensional transesophageal echocardiography from the screening visit by an independent echo core lab to characterize subject variability. Coaptation gap measurements were taken in both the transgastric short-axis (TG SAX) and RV inflow/outflow views. The independent echo core lab performed a detailed assessment of the tricuspid valve on 135 consecutive subjects with available TG SAX views from 24 sites. Tricuspid valve morphologies included 2 to 5 leaflets, with a non-trileaflet valve in 28% of subjects and ≥4 leaflets in 21% of subjects. The etiology of TR was functional in 91% (96/105), mixed in 7% (7/105), and lead induced in 2% (2/105) of subjects. Leaflet mobility was mildly restricted in 69% (78/113) and moderately restricted in 7% (8/113) of subjects. Annulus diameter averaged 4.7±0.7cm with a range of 2.5 to 6.2cm. From the TG SAX view, the coaptation gap measured 8.1±3.1 and 5.2±2.3mm in the central and mid regions of the anterior-septal coaptation line and 6.6±3.2 and 3.8±2.1mm in the central and mid regions of the septal-posterior coaptation line, respectively. From the right ventricular inflow/outflow view, the coaptation gap measured 4.7±2.4, 5.2±2.4, and 4.6±3.0mm in the anterior, mid, and posterior regions of the tricuspid valve, respectively. Thirty-day TR reduction (by number of grades) was similar among subjects with coaptation gaps of <7mm, 7 to 10mm, and >10mm. A broad range of anatomies was observed in this postmarket population. Characterization of the tricuspid valve and coaptation gap will help to better understand and better define the target patient population for tricuspid TEER therapy.

Applying the TRILUMINATE Eligibility Criteria to Real-World Patients Receiving Tricuspid Valve Transcatheter Edge-to-Edge Repair

BackgroundAccording to the TRILUMINATE (Clinical Trial to Evaluate Cardiovascular Outcomes in Patients Treated With the Tricuspid Valve Repair System) trial, transcatheter tricuspid edge-to-edge repair (T-TEER) improves quality of life beyond medical treatment, while no effects on heart failure hospitalization (HFH) and survival were observed at 1 year. However, the generalizability of the TRILUMINATE trial to real-world conditions remains a subject of discussion. ObjectivesThe aim of this study was to apply the clinical TRILUMINATE inclusion and exclusion criteria to a real-world T-TEER patient group and evaluate symptomatic and survival outcome in TRILUMINATE-eligible and TRILUMINATE-ineligible patients. MethodsClinical TRILUMINATE inclusion and exclusion criteria were applied to a cohort of patients who underwent T-TEER at 5 European centers from 2016 to 2022. Study patients were compared regarding baseline characteristics, survival, HFH, and symptomatic outcomes as measured by NYHA functional class, a quality-of-life questionnaire and 6-minute walk distance. ResultsOf 962 patients, 54.8% were classified as TRILUMINATE eligible, presenting with superior left ventricular function and fewer comorbidities compared with the ineligible population. Tricuspid regurgitation reduction, improvement in NYHA functional class, quality of life, and exercise capacity were comparable in both groups. However, the 1-year survival and HFH rates significantly differed (tricuspid regurgitation ≤2+ at discharge, 82% vs 85%; survival, 85% vs 75%; HFH, 14% vs 22% for eligible vs ineligible patients). ConclusionsThe observed differences in survival and HFH outcomes suggest a limited generalizability of TRILUMINATE to real-world conditions and indicate the need for additional studies evaluating the outcomes after T-TEER in less selected patient populations.

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.

Long-term outcomes of transcatheter tricuspid valve repair in prohibitive risk patients: futility or benefit?

Abstract Background Transcatheter tricuspid valve repair (TTVR) for tricuspid regurgitation (TR) is an emerging treatment option in inoperable patients. However, patient selection is challenging, and mostly predetermined by comorbidities and non-specific surgical risk scores. Current guidelines (1) distinguish between high-risk (HR) and prohibitive risk (PR) patients, in order to avoid clinical and procedural futility. Therefore, the aim of this study was to understand if PR patients can benefit from TTVR long-term. Methods Forty-one consecutive patients with severe TR were assessed by the heart team, considered inoperable, and underwent edge-to-edge TTVR at our institution between November 2020 and January 2022. They were divided into a PR (n=23) and an HR group (n=18), in accordance with the latest guidelines (1). Subgroup allocation took into account STS (Society of Thoracic Surgeons) risk score, and several comorbidities (Figure 1A). Mean age was 82.2±5.9 (PR) vs 81.1±3.5 years (HR), with mean STS-Score 14.3±6.7% vs 6.2±1.6% (Figure 1B). Results The primary efficacy endpoint of at least one-grade TR reduction by 30 days was recorded in 92.7% of all patients, with no device related complications. By 12 months, 6 patients died, 5 PR and 1 HR, and MACE rate was 18.1%. Secondary endpoints addressed symptoms, quality of life and multiorgan function, which improved in both groups (Figure 2). More precisely, at inclusion, all patients in the PR group were in NYHA class III and IV, while after 12 months only 27.7%. In comparison, there were no more HR patients in NYHA stage III and IV, after one year. Similarly, self-reported quality of life increased, as assessed by the "Kansas City Cardiomyopathy Questionnaire" (KCCQ) score, which increased by 23±18.2 (p&amp;lt;0.001) in PR and 27.5±16.1 (p&amp;lt;0.001) points in HR patients, respectively. Walk distance in the 6-minute test also improved by 79.2±82 (p&amp;lt;0.001) vs 113.6±72.8 (p&amp;lt;0.001) meters. Renal and liver function were also impacted by TR reduction, with statistical significance in the PR group [GFR- Glomerular Filtration Rate improvement from 46.7±13.9ml/min/1,73m2 to 51.9±18.1 (p=0.045) vs 62.1±17.1 to 62.1±18.5 (p=0.990); AST- Aspartate Aminotransferase from 33.7±15.4U/L to 27.3±12.3 (p=0.001) vs 33.2±26.1 to 26.2±6.8 (p=0.188)]. Furthermore, TR reduction led to long-term reverse cardiac remodeling, as right ventricular systolic function increased [TAPSE from 14.2±3.1mm to 17.7±2.2 (p&amp;lt;0.001) vs 16.4±3.5 to 20.7±5.4 (p&amp;lt;0.001)], and right atrial size decreased [indexed volume from 93.5±39.1 ml/m2 to 66.3±42.6 (p=0.005) vs 86.3±57.8 to 63.3±59.5 (p=0.032)]. Conclusions TTVR is feasible in very sick symptomatic patients and is associated with improved quality of life, functional capacity, multiorgan function and reverse cardiac remodeling. Patient selection based on risk assessment with surgical risk scores may deprive many symptomatic inoperable patients of this specific percutaneous treatment.Figure 1Figure 2

Efficacy and evolution of edge-to-edge transcatheter valve repair procedures

Abstract Background Edge-to-edge transcatheter mitral valve repair (M-TEER) has shown safety and efficacy in reducing secondary mitral regurgitation (MR) (1,2) and led to the development of similar devices for transcatheter valve repair (T-TEER) for tricuspid regurgitation (TR) (Fig. 1A). However, T-TEER implementation is challenging due to complex valve anatomy and periprocedural imaging. We sought to understand to which extent procedural success of M-TEER changed over time and possibly impacted T-TEER results. Methods We retrospectively analyzed intraprocedural reduction of secondary MR and TR after release of a valve specific device, between 2018, when M-TEER was implemented in our center, through 2020, when T-TEER procedures started, and up to the end of 2022. We compared results between the 55 T-TEER procedures performed (age 81.8±4.7, 55% females) and 3 M-TEER cohorts: the very first 55 M-TEER, the last 55 M-TEER before T-TEER, and the very last 55 M-TEER (overall mean-age 78.4±8.2, 49% females) (Fig. 1B). Severe MR III/IV was defined by an effective regurgitation orifice area (EROA) of 20-39mm², and IV/IV by EROA ≥40mm², while TR was evaluated using the I/V to V/V classification. Considering that a 5-grade reduction of TR is either not possible or not desirable, the extension of regurgitation reduction for both valves was set on a scale from 1- to 4-grade. Also, optimal results were defined as residual MR 0+ (none or trace) or TR I+ (mild or mild to moderate), while acceptable results were considered MR I+ and TR II+ (moderate or moderate to severe). Results In all groups, regurgitation was successfully and significantly reduced within-group (Fig. 1C). MR reduction to optimal or acceptable levels increased over time from 60% at the start of the M-TEER program to 78% after 12-18 months (p=0.039), and 84% (p=0.005) after approximately 3 years. Accordingly, the extent of regurgitation reduction significantly improved between the first 2 M-TEER cohorts (p=0.016), as well as the first and the last 55 M-TEER (p=0.045), with no significant change from the second to the third population (p=0.267) (Fig. 2). Two years after the first M-TEER, T-TEER with valve specific devices was implemented and achieved 84% optimal or acceptable residual TR, better than initial M-TEER (p=0.005) and similar to the second (p=0.466) and third M-TEER cohorts (p=1.000). In terms of extent of regurgitation reduction, T-TEER also performed similar to the very first (p=0.645) and the very last M-TEER procedures (p=0.076), despite higher mean-EROA (78.5±32.2mm² vs 44.8±16.1mm² in all MR patients, p&amp;lt;0.001), more complex anatomy, more challenging imaging, and sicker patients (mean-EuroSCORE II 8.8±6.6% vs 6.4±5.3% in all MR patients, p&amp;lt;0.001). Conclusions In our center, gain in knowledge and experience, coupled with technological advances, have significantly impacted procedural M-TEER success over time and allowed similar successful implementation of a T-TEER program.Figure 1Figure 2

Impact of right ventricular to pulmonary artery coupling on remodeling and outcome in patients undergoing transcatheter edge-to-edge mitral valve repair

Abstract Background Right ventricular to pulmonary artery (RV-PA) coupling has recently been shown to be associated with outcome in valvular heart disease. However, longitudinal data on RV dysfunction and reverse cardiac remodeling in patients following transcatheter edge-to-edge mitral valve repair (M-TEER) are scarce. Methods Consecutive patients with primary as well as secondary mitral regurgitation (MR) were prospectively enrolled and had comprehensive echocardiographic and invasive hemodynamic assessment at baseline. Kaplan-Meier estimates and multivariable Cox-regression analyses were performed using a composite endpoint of heart failure hospitalization and death. Results Between April 2018 to January 2021, 156 patients (median 78 y/o, 55% female, EuroSCORE II: 6.9%) underwent M-TEER. On presentation, 64% showed impaired RV-PA coupling defined as tricuspid annular plane systolic excursion to pulmonary artery systolic pressure (TAPSE/PASP) ratio &amp;lt;0.36. Event-free survival rates at 2 years were significantly lower among patients with impaired coupling (57 vs. 82%, p&amp;lt;0.01), both in patients with primary (64 vs. 91%, p=0.01) and secondary MR (54 vs. 76%, p=0.03). On multivariable Cox-regression analyses adjusted for baseline, imaging, hemodynamic, and procedural data, TAPSE/PASP ratio &amp;lt;0.36 was independently associated with outcome (adj.HR 2.74, 95%CI: 1.17-6.43, p=0.02). At 1-year follow-up, RV-PA coupling improved (TAPSE: ∆ +3mm, PASP: ∆ -10mmHg, p for both &amp;lt;0.01), alongside with a reduction in tricuspid regurgitation (TR) severity (grade ≥II: 77 to 54%, p&amp;lt;0.01). Conclusion TAPSE/PASP ratio was associated with outcome in patients undergoing M-TEER for primary as well as secondary MR. RV-PA coupling, alongside with TR severity, improved after M-TEER and might thus provide prognostic information in addition to established markers of poor outcome.Graphical Abstract

Abstract 13679: Personalized Guidance of Edge-to-Edge Transcatheter Tricuspid Valve Repair

Introduction: Transcatheter edge-to-edge tricuspid valve repair (T-TEER) for tricuspid regurgitation (TR) is always guided by TEE. Hypothesis: Safety and efficacy of T-TEER can be increased by multimodality imaging (MMI) guidance. Methods: From December 2020 to January 2022, we performed T-TEER in 40 inoperable patients. All patients received TTE, TEE and cardiac CT screening, and were assigned to a MMI (n=17) guidance group, provided good TTE acoustic window, or otherwise classical TEE (n=23). Multimodality imaging employed the 4 right-sided chamber views. Accordingly, the 1-chamber view was obtained in the transgastric short-axis view on TEE, but also from a modified subcostal TTE short axis. The 2-chamber view was visualized from a low-esophageal position, or from a parasternal long axis view of the right ventricle. The 3-chamber view was seen on mid-esophageal TEE 50-100°, but also in the parasternal short axis view. Finally, the 4-chamber view was obtained on mid-esophageal 0-30°, or the classical four-chamber TTE view. CT derived fluoroscopic angulations of these views allowed interventionalists and imaging specialists to speak a common language. Results: Device success was achieved in all patients, with 1.5±0.6 implanted clips / patient in the MMI vs 1.5±0.5 in the TEE group (p=0.851). Device times were 66.1±35.1 vs 58.7±27.5 minutes (p=0.459). TR reduction was successful in 94% vs 95% of patients, p=1.000. Two- or more grade TR improvement occurred in 65% vs 52% of cases. There were no device associated complications but 3 TEE-related gastro-esophageal bleedings occurred in the 2 nd group. By 12 months, 4 vs 8 patients (p=0.504) were readmitted for acute heart failure, and 2 vs 4 (p=0.686) died. NYHA class decreased by one grade in all survivals. However, Kansas City Cardiomyopathy Questionnaire score and 6-minute walk distance significantly increased in each respective group, more with MMI ( Δ 29±21.4 vs 22±13.6 points, p=0.227; Δ 101±100.4 vs 85±64 meters, p=0.121). Conclusions: A patient-tailored MMI approach to T-TEER guidance, by using TTE in patients with good acoustic window and cardiac CT for fluoroscopic determination of the 4 right-sided chamber views, is feasible and improves safety, procedural success and, in turn, clinical outcomes.

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.

30-Day Outcomes of Transcatheter Tricuspid Annuloplasty With the K-Clip System: A Single-Center, Observational Study

BackgroundSurgery for isolated functional tricuspid regurgitation (TR) poses a high risk. Several transcatheter approaches are being evaluated for the treatment of such patients. The K-Clip system is a percutaneous approach designed for functional TR; however, its utility remains unknown. ObjectivesThis study aimed to report the 30-day echocardiographic and clinical outcomes with the K-Clip system for severe TR, including changes in TR severity and NYHA functional class. MethodsTranscatheter tricuspid valve annuloplasty was performed in 39 patients with intermediate or high surgical risk who underwent the K-Clip system. The right internal jugular vein procedure was performed with annuloplasty guided by fluoroscopy and echocardiography. The primary outcomes were clinical success and all-cause mortality at the 30-day follow-up. ResultsThe K-Clip was successfully implanted in all cases, with 1 to 3 devices deployed. At the 30-day follow-up, none of the patients had died. TR severity was reduced by at least one grade in all patients. There were no severe procedural or 30-day adverse events, except for 1 new pacemaker implantation. The proportion of NYHA class III-IV patients decreased from 79.5% to 5.1%, and the ascites disappeared. The 6-minute walk distance increased by 78 m (P < 0.05), and the Kansas City Cardiomyopathy Questionnaire score improved by 11 points (P < 0.05). ConclusionsThe K-Clip device is practical, safe, and effective for patients with severe TR. A 30-day reduction in TR and enhanced cardiac function and quality of life were associated with transcatheter tricuspid annuloplasty using the K-Clip device, according to short-term follow-up studies. (Confirmatory Clinical Study of Treating Tricuspid Regurgitation With K-Clip TM Transcatheter Annuloplasty System [TriStar]; NCT05173233)

Health Status After Transcatheter Tricuspid-Valve Repair in Patients With Severe Tricuspid Regurgitation

BackgroundIn the TRILUMINATE Pivotal (Trial to Evaluate Cardiovascular Outcomes in Patients Treated with the Tricuspid Valve Repair System Pivotal), tricuspid transcatheter edge-to-edge repair (T-TEER) reduced tricuspid regurgitation (TR) and improved health status compared with medical therapy alone with no benefit on heart failure hospitalizations or survival. ObjectivesThe purpose of this study was to better understand the health status benefits of T-TEER within the TRILUMINATE Pivotal trial. MethodsTRILUMINATE randomized patients with severe TR to T-TEER (n = 175) or medical therapy (n = 175). Health status was assessed at baseline and at 1, 6, and 12 months with the Kansas City Cardiomyopathy Questionnaire (KCCQ) (range 0-100; higher = better), which was compared between treatment groups using mixed effects linear regression. Alive and well was defined as KCCQ overall summary score ≥60 and no decline from baseline of >10 points at 1 year. ResultsCompared with medical therapy, T-TEER significantly improved health status at 1 month (mean between-group difference in KCCQ overall summary score 9.4 points; 95% CI: 5.3-13.4 points), with a small additional improvement at 1 year (mean between-group difference 10.4 points; 95% CI: 6.3-14.6 points). T-TEER patients were more likely to be alive and well at 1 year (T-TEER vs medical therapy: 74.8% vs 45.9%; P < 0.001), with a number needed to treat of 3.5. Interaction analyses demonstrated that the benefit of T-TEER diminished as baseline KCCQ overall summary score increased (Pint < 0.001). Exploratory analyses suggested that much of the health status benefit of T-TEER could be explained by TR reduction and that improvement in health status after T-TEER was strongly correlated with reduced 1-year mortality and heart failure hospitalization. ConclusionsT-TEER with the TriClip system resulted in substantial and sustained health status improvement in patients with severe TR compared with medical therapy alone.

Impact of right ventricular-to-pulmonary artery coupling on remodeling and outcome in patients undergoing transcatheter edge-to-edge mitral valve repair.

Right ventricular-to-pulmonary artery (RV-PA) coupling has recently been shown to be associated with outcome in valvular heart disease. However, longitudinal data on RV dysfunction and reverse cardiac remodeling in patients following transcatheter edge-to-edge mitral valve repair (M-TEER) are scarce. Consecutive patients with primary as well as secondary mitral regurgitation (MR) were prospectively enrolled and had comprehensive echocardiographic and invasive hemodynamic assessment at baseline. Kaplan-Meier estimates and multivariable Cox-regression analyses were performed, using a composite endpoint of heart failure hospitalization and death. Between April 2018 and January 2021, 156 patients (median 78 y/o, 55% female, EuroSCORE II: 6.9%) underwent M-TEER. On presentation, 64% showed impaired RV-PA coupling defined as tricuspid annular plane systolic excursion to pulmonary artery systolic pressure (TAPSE/PASP) ratio < 0.36. Event-free survival rates at 2years were significantly lower among patients with impaired coupling (57 vs. 82%, p < 0.001), both in patients with primary (64 vs. 91%, p = 0.009) and secondary MR (54 vs. 76%, p = 0.026). On multivariable Cox-regression analyses adjusted for baseline, imaging, hemodynamic, and procedural data, TAPSE/PASP ratio < 0.36 was independently associated with outcome (adj.HR 2.74, 95% CI 1.17-6.43, p = 0.021). At 1-year follow-up, RV-PA coupling improved (TAPSE: ∆ + 3mm, PASP: ∆ - 10mmHg, p for both < 0.001), alongside with a reduction in tricuspid regurgitation (TR) severity (grade ≥ II: 77-54%, p < 0.001). TAPSE/PASP ratio was associated with outcome in patients undergoing M-TEER for primary as well as secondary MR. RV-PA coupling, alongside with TR severity, improved after M-TEER and might thus provide prognostic information in addition to established markers of poor outcome.

The Interaction Between Tricuspid Regurgitation and Cardiac Resynchronization Therapy Response in Patients with Congestive Heart Failure

Background: Aggravation of tricuspid regurgitation (TR) is a predictable issue following cardiac device implantation, while its clinical importance is subject to debate. Objectives: We aimed to recognize the alteration of TR following cardiac resynchronization therapy (CRT) and its effect on the response to CRT. Methods: In this prospective study, 70 candidates were recruited for CRT from those who visited two university hospitals in Tehran and Ahvaz (Iran) from January 2012 to March 2013. Baseline specifications were recorded for all the participants. All the patients underwent echocardiography before and 6 months after CRT administration. They were then divided into two categories for further comparison: (1) Patients with no or mild TR and (2) patients with moderate-to-severe TR. The echocardiographic response to CRT was defined as a left ventricular end-systolic volume (LVESV) decrease of &gt;15% or left ventricular ejection fraction (LVEF) advancement of &gt;5%. The clinical response to CRT was one class improvement based on the New York Heart Association (NYHA) class. Results: Of the patients, 24 had moderate-to-severe TR. Although the increase in cases with moderate-to-severe TR after CRT was not significant, the aggravation of TR degree after the procedure was significant (P = 0.002). Moreover, the NYHA class significantly improved after the CRT (P = 0.02). The number of cases with a clinical response to CRT based on improvement of the NYHA class was significantly greater in patients with no TR or mild TR at baseline (P = 0.003). There was no significant variation in response to CRT among patients who experienced TR exacerbation after CRT compared with those who had no change or a reduction in TR. Conclusions: This study demonstrated that TR severity was exacerbated following CRT, but this alternation in TR severity had no significant effect on the response to CRT. Therefore, the presence and development of TR before and after CRT must not affect the criteria for choosing cardiac resynchronization therapy for appropriate patients.

Predictors of Improvement in Concomitant Tricuspid Regurgitation Following Transcatheter Edge-to-Edge Mitral Valve Repair.

Improvement in concomitant tricuspid regurgitation (TR) after mitral valve transcatheter edge-to-edge repair (M-TEER) for mitral regurgitation (MR) occurs frequently; however factors determining the post-procedural course of TR are not well understood. We investigated the parameters associated with TR improvement after M-TEER. A total of 300 patients were consecutively included in this retrospective analysis. MR and TR severity as well as heart chamber metrics were assessed before the procedure and at follow-up. Device success was achieved in 97.3% of patients. TR decreased in 30.2% of patients. Patients with improved TR were more often female, had more severe TR at baseline, and their right heart dimensions at baseline trended to be smaller. Female sex (odds ratio (OR) 2.997), baseline MR-Grade (OR 3.181) and baseline TR-Grade (OR 2.653) independently predicted TR reduction. More pronounced right heart reverse remodeling was observed in patients with improved TR. TR regression independently predicted lower mortality (hazard ratio (HR) 0.333, 95% confidence interval 0.112-0.996, p = 0.049). A reduction in concomitant TR severity after M-TEER occurred mainly in females and in patients with high-grade TR and MR at baseline. TR regression is associated with better survival after M-TEER.

Comparison of procedural characteristics of percutaneous annuloplasty and edge-to-edge repair for the treatment of severe tricuspid regurgitation.

In recent years, new interventional therapies for tricuspid regurgitation (TR) demonstrated their effectiveness in reducing TR severity and improving symptoms. Currently, tricuspid transcatheter edge-to-edge repair (T-TEER) and percutaneous annuloplasty are the most widely used techniques in Europe. In this retrospective study, we compared procedural characteristics and learning curves of both TR devices in a real-world cohort. Eligible patients with severe to torrential TR underwent either percutaneous annuloplasty or T-TEER as recommended by the local heart team. Patients with combined mitral and tricuspid interventions were excluded from the analysis. The study focused on procedural characteristics, TR reduction and learning curves. A total of 122 patients underwent either percutaneous annuloplasty (n = 64) or T-TEER (n = 58) with a technical and device success rate of 98% and 97%, respectively. Reasons for technical failure included right coronary artery (RCA) dissection prior to percutaneous annuloplasty, and two single leaflet device attachments (SLDA) during T-TEER implantation. The mean improvement of TR severity was 2.4 ± 0.8 degrees after T-TEER and 2.5 ± 0.8 after percutaneous annuloplasty. T-TEER procedures were shorter in terms of both procedure time and radiation exposure, while percutaneous annuloplasty, although taking longer, showed a significant reduction in procedure time over the course of the analysed period. In summary, both interventional therapies reduce TR severity by approximately two degrees when used in the appropriate anatomy. The learning curve for annuloplasty group showed a significant decrease of procedure times.

Tricuspid Transcatheter Edge-to-edge Repair

Tricuspid regurgitation (TR) is a common disease associated with significant morbidities and mortality. In this review, the new grading scheme of TR, the tricuspid valve anatomy and also the different TR mechanisms are summarised. Recently, there have been many evolving technologies to treat TR, and transcatheter edge-to-edge repair is one of the most well-established techniques. Transcatheter edge-to-edge repair is shown to be effective in TR reduction. With increasing clinical experience, a number of echocardiographic predictors of optimal TR reduction have been identified, and a standardised transoesophageal echocardiogram protocol and also different techniques to improve the procedural success are presented. Finally, the uncertainties on the optimal timing of TR intervention and on the clinical benefit of transcatheter edge-to-edge repair are also addressed.

Procedural success of transcatheter annuloplasty in ventricular and atrial functional tricuspid regurgitation.

Transcatheter annuloplasty is meant to target annular dilatation and is therefore mainly applied in functional tricuspid regurgitation (TR). Due to recent recognition of varying disease pathophysiology and differentiation of ventricular and atrial functional TR (VFTR and AFTR), comparative data regarding procedural success for both disease entities are required. In this consecutively enrolled observational cohort study, 65 patients undergoing transcatheter annuloplasty with a Cardioband® device were divided into VFTR (n = 35, 53.8%) and AFTR (n = 30, 46.2%). Procedural success was assessed by comparing changes in annulus dilatation, vena contracta (VC) width, effective regurgitation orifice area (EROA), as well as reduction in TR severity. Overall, improvement of TR by at least two grades was achieved in 59 patients (90.8%), and improvement of TR by at least three grades was realised in 32 patients (49.2%). Residual TR of ≤2 was observed in 52 patients (80.0%). No significant differences in annulus diameter reduction [VFTR: 11 mm (9-13) vs. AFTR: 12 mm (9-16), p = 0.210], VC reduction [12 mm (8-14) vs. 12 mm (7-14), p = 0.868], and EROA reduction [0.62 cm2 (0.45-1.10) vs. 0.54 cm2 (0.40-0.70), p = 0.204] were reported. Improvement by at least two grades [27 (90.0%) vs. 32 (91.4%), p = 1.0] and three grades [14 (46.7%) vs. 18 (51.4%), p = 0.805] was similar in VFTR and AFTR, respectively. No significant difference in the accomplishment of TR grade of ≤2 [21 (70.0%) vs. 31 (88.6%), p = 0.118] was noted. According to our results from a real-world scenario, transcatheter annuloplasty with the Cardioband® device may be applied in both VFTR and AFTR with evidence of significant procedural TR reduction.

Multidetector CT-derived tricuspid annulus measurements predict tricuspid regurgitation reduction after transcatheter aortic valve replacement

To use multidetector row computed tomography (MDCT)-derived tricuspid annulus (TA) measurements to identify predictors for tricuspid regurgitation (TR) reduction after transcatheter aortic valve replacement (TAVR), and to investigate the impact of TR change on prognosis. A retrospective, single-centre study was conducted on consecutive patients who underwent TAVR with concomitant baseline mild or more severe TR from April 2012 to April 2022. TA parameters were measured using MDCT. The study comprised 266 patients (mean age 74.2±7.6 years, 147 men) and 45.1% had more than one grade of TR reduction at follow-up. Independent predictors of TR reduction at follow-up were distance between TA centroid and antero-septal commissure (odd ratio [OR] 0.776; 95% confidence interval [CI]: 0.672-0.896, p=0.001), baseline TR of moderate or worse (OR 4.599; 95% CI: 2.193-9.648, p<0.001), systolic pulmonary artery pressure (OR 1.018; 95% CI: 1.002-1.035, p=0.027), age (OR 0.955; 95% CI: 0.920-0.993, p=0.019), and pre-existing atrial fibrillation (OR 0.209; 95% CI: 0.101-0.433, p<0.001). Patients without TR reduction had higher rates of rehospitalisation (hazard ratio [HR] 0.642; 95% CI: 0.413-0.998, p=0.049). The MDCT-derived TA parameter was predictive of TR reduction after TAVR. Persistent TR after TAVR was associated with higher rates of rehospitalisation.

Feasibility and Efficacy of Transcatheter Tricuspid Valve Repair in Patients with Cardiac Implanted Electrical Devices and Trans-Tricuspid Leads.

Transcatheter tricuspid valve repair using the edge-to-edge-technique (TEER) has emerged as an alternative therapy in patients with severe tricuspid regurgitation (TR) and high surgical risk. This study aimed to evaluate the feasibility and efficacy of tricuspid valve TEER in patients with cardiac implanted electric devices (CIEDs). All patients who underwent tricuspid valve TEER at our center were retrospectively included. Patients were classified according to the presence of CIEDs. Procedure success was defined as implantation of at least one clip and the reduction of TR of at least one grade. Procedure success and intrahospital outcome were compared between the two groups. One-hundred and six consecutive patients underwent tricuspid TEER (age 80.1 ± 6.4 years, male = 42; 39.6%). Among them, 25 patients (23.6%, age 80.6 ± 7.3 years, male = 14; 56%) had CIEDs. Patients with CIEDs had a significantly lower left ventricular ejection fraction (LV-EF) compared to those without CIEDs (47.2 ± 15% vs. 56.2 ± 8.2%, p = 0.004, respectively). Moreover, arterial hypertension was more common in patients with CIEDs (96% vs. 79%, p = 0.048). The success of the procedure did not differ between the non-CIED vs. CIED group (93.8% vs. 92%, p = 0.748). Furthermore, the number and position of implanted clips, the duration of the procedure, the post-procedural pressure gradient across the tricuspid valve, and post-procedural TR severity were comparable between both groups. Tricuspid valve TEER is feasible and efficient in patients with CIEDs. The success of the procedure, as well as the intrahospital outcome were comparable between patients with and without CIEDs.