Severe Symptomatic Tricuspid Regurgitation Research Articles

Transcatheter Valve Replacement in Severe Tricuspid Regurgitation.

Severe tricuspid regurgitation is associated with disabling symptoms and an increased risk of death. Data regarding outcomes after percutaneous transcatheter tricuspid-valve replacement are needed. In this international, multicenter trial, we randomly assigned 400 patients with severe symptomatic tricuspid regurgitation in a 2:1 ratio to undergo either transcatheter tricuspid-valve replacement and medical therapy (valve-replacement group) or medical therapy alone (control group). The hierarchical composite primary outcome was death from any cause, implantation of a right ventricular assist device or heart transplantation, postindex tricuspid-valve intervention, hospitalization for heart failure, an improvement of at least 10 points in the score on the Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS), an improvement of at least one New York Heart Association (NYHA) functional class, and an improvement of at least 30 m on the 6-minute walk distance. A win ratio was calculated for the primary outcome by comparing all possible patient pairs, starting with the first event in the hierarchy. A total of 267 patients were assigned to the valve-replacement group and 133 to the control group. At 1 year, the win ratio favoring valve replacement was 2.02 (95% confidence interval [CI], 1.56 to 2.62; P<0.001). In comparisons of patient pairs, those in the valve-replacement group had more wins than the control group with respect to death from any cause (14.8% vs. 12.5%), postindex tricuspid-valve intervention (3.2% vs. 0.6%), and improvement in the KCCQ-OS score (23.1% vs. 6.0%), NYHA class (10.2% vs. 0.8%), and 6-minute walk distance (1.1% vs. 0.9%). The valve-replacement group had fewer wins than the control group with respect to the annualized rate of hospitalization for heart failure (9.7% vs. 10.0%). Severe bleeding occurred in 15.4% of the valve-replacement group and in 5.3% of the control group (P = 0.003); new permanent pacemakers were implanted in 17.4% and 2.3%, respectively (P<0.001). For patients with severe tricuspid regurgitation, transcatheter tricuspid-valve replacement was superior to medical therapy alone for the primary composite outcome, driven primarily by improvements in symptoms and quality of life. (Funded by Edwards Lifesciences; TRISCEND II ClinicalTrials.gov number, NCT04482062.).

Transcatheter Repair of Tricuspid Valve Regurgitation: A Systematic Review.

Introduction: Clinically significant severe tricuspid regurgitation (TR) is a common untreated pathology associated with increased mortality. Even though surgical valve replacement has been the mainstay option, transcatheter intervention is a novel and potentially effective tool. To the best of our knowledge, this is the first systematic review that assessed and compared clinical and echocardiographic outcomes of coaptation and annuloplasty devices in patients with clinically significant TR. Methods: PubMed, the Cochrane Central Register of Controlled Trials, and EMBASE were searched for articles published from August 2016 until February 2023. Primary endpoints were technical and procedural successes. Secondary endpoints were TR grade, NYHA, change in 6 min walk distance (6MWD), and echocardiographic parameters at 30-day follow-up. Results: We included thirty-eight studies consisting of 2273 patients with severe symptomatic TR (NYHA III-IV 77% and severe/massive/torrential TR 83.3%) and high surgical risk (mean EUROSCORE of 7.54). The technical success for the annuloplasty devices was 96.7% and for the coaptation device was 94.8%. The procedural success for the annuloplasty devices was 64.6% and for the coaptation device was 81.4%. The 6MWD increased by 17 m for the coaptation devices and increased by 44 m after 30 days for the annuloplasty devices. A reduction in TR grade to <2 was seen in 70% of patients with coaptation and 59% of patients with annuloplasty devices. Conclusions: Transcatheter tricuspid valve intervention appears to be feasible and is associated with favorable outcomes.

Comparing outcomes of transcatheter tricuspid valve replacement and medical therapy for symptomatic severe tricuspid regurgitation: a retrospective study

BackgroundImpaired hospitalizations for heart failure (HHF) and mortality are associated with tricuspid regurgitation (TR).ObjectivesThe objective of this study was to investigate the benefit of transcatheter tricuspid valve replacement (TTVR) over guideline-directed medical therapy (GDMT) in patients with symptomatic severe TR.MethodsBetween May 2020 and April 2023, 88 patients with symptomatic severe TR were treated in our center. Of these, 57 patients received GDMT alone, and 31 patients underwent combined TTVR and GDMT. We collected and analyzed baseline data, and follow-up information for both groups. The primary endpoints were all-cause mortality and the combined endpoint (including all-cause mortality and HHF).ResultsAt a median follow-up of 20 (IQR 10–29) months, significant improvements were shown in TR severity, right ventricular function, and dimensions in TTVR group (all P < 0.001). It also resulted in superior survival rates (75.8% vs. 48.4%, P = 0.019), improved freedom from combined endpoint (61.5% vs. 45.9%, P = 0.007) and fewer major adverse events. After stratification by TRI-SCORE, the subgroup with < 6 points in the TTVR group exhibited a significant difference in the combined endpoint compared to the other subgroups (all P < 0.05), while no significant differences were observed in the GDMT subgroups (P = 0.680).ConclusionsThe utilization of LuX-Valve in TTVR effectively improves TR and is associated with lower rates of major adverse events, HHF and all-cause mortality. The TRI-SCORE may help identify higher-benefit patients with TR from TTVR.Clinical trial registration ClinicalTrials.gov Protocol Registration System (NCT02917980).

TRISCEND II: Novel Randomized Trial Design for Transcatheter Tricuspid Valve Replacement

BackgroundSevere tricuspid regurgitation remains largely undertreated given limited treatment options. Transcatheter tricuspid valve interventions have emerged as a promising therapy for these patients, and the TRISCEND II pivotal trial is the first randomized controlled trial to evaluate transcatheter tricuspid valve replacement (TTVR). ObjectivesThe TRISCEND II pivotal trial studies the transcatheter EVOQUE tricuspid valve replacement system using an FDA Breakthrough Device Designation – a program intended to provide timely access to medical devices by speeding up development, assessment, and review. MethodsThe TRISCEND II trial is a prospective, multicenter trial that randomizes patients with symptomatic severe tricuspid regurgitation to treatment with either TTVR in conjunction with optimal medical therapy or optimal medical therapy alone. The trial's novel 2-phase design evaluates 30-day safety and 6-month effectiveness endpoints for the first 150 patients in the initial phase and a 1-year safety and effectiveness endpoint for the full cohort of 400 patients in the second phase. ResultsThe TRISCEND II trial's 2-phase trial design provided an opportunity for early review and led to the first commercial approval of a TTVR system. ConclusionsThe design of the TRISCEND II trial will likely inform future transcatheter tricuspid device trials. Condensed AbstractThe TRISCEND II pivotal trial is the first randomized controlled trial of transcatheter tricuspid valve replacement (TTVR). It was designed under the FDA's Breakthrough Device Program to bring a novel TTVR therapy to patients with limited treatment options. A 2-phase design allowed for early review of safety and effectiveness outcomes followed by a full-cohort safety and effectiveness endpoint in the second phase at 1 year. This approach led to approval of the first commercial transcatheter therapy for tricuspid valve replacement.

Long-term structural right heart remodeling following transcatheter annuloplasty for treating severe tricuspid regurgitation assessed by CT scan

Abstract Background Transcatheter tricuspid annuloplasty has emerged as an attractive percutaneous therapy for patients with severe symptomatic tricuspid regurgitation. Cardioband (Edwards) was the first dedicated CE marked percutaneous device for tricuspid regurgitation. Despite mid-long-term clinical safety and efficacy demonstrated in early feasibility trials and registries, there is no data about its impact on right heart structural remodeling using computed tomography (CT). Our aim was to assess right heart remodeling and changes in the tricuspid annulus (TA) one year after Cardioband implantation. Methods A total of 30 patients were prospectively included in the study; 21 of them had baseline and at least 1-year follow-up CT analysis. The average time from the basal CT scan and the procedure was 118±136 days, and from the intervention to follow-up CT scan was 468±251 days. 2D and 3D analyses were performed with 3mensio version 10.3 at baseline and at least 12 months after Cardioband implantation. Results There was a significant decrease in right ventricular dimensions at follow-up (right ventricular basal diameter was 53.65 ± 8.45 mm at baseline Vs 48.54 ± 9.12 mm at 1-year follow-up; right ventricular mid cavity diameter was 40.30 ± 9.10 mm at baseline Vs 34.22 ± 9.22 at the end of follow-up, and right ventricular longitudinal diameter was 75.43 ± 9.85 mm at baseline Vs 69.95 ± 9.96 mm at the end of follow-up, all of them were statistically significant). A reduction in right atrial dimension was also observed (longitudinal diameter 66.86 ± 7.63 mm at baseline Vs 64.89 ± 9.99 mm at the end of follow-up; transverse diameter of 61.62 ± 8.38 mm at baseline Vs 60.59 ± 8.3 mm at the end of follow-up, p&amp;lt;0.001). There was a significant decrease in the area and diameters of the dilated TA (area at baseline 16.51 ± 3.06 cm2 vs 8.90 ± 2.71 cm2 at the end of follow-up, p=0.02; septolateral diameter 45.42 ± 5.02 mm at baseline vs 33.87 ± 5.09 mm at the end of follow-up, p=0.01). Conclusions Long-term favorable right ventricular chambers and TA remodeling was observed following Cardioband implantation assessed by CT scan. This finding could explain the long-term clinical benefit demonstrated in feasibility studies.Right heart remodeling after Cardioband

Tricuspid Valve Regurgitation: Current Understanding and Novel Treatment Options.

Managing patients with severe symptomatic tricuspid regurgitation (TR) remains extremely challenging, with a lack of consensus on when and how to treat it. Tricuspid valve pathology has been disregarded for a very long time because of the established belief that treating left-sided heart diseases would lead to the resolution or significant improvement of TR. Initially considered benign, severe TR has been found to be a strong predictor of prognosis. Despite the increasing prevalence and the disabling nature of this disease, the great majority of patients with clinically significant TR have seldom been considered for structural interventions. Numerous surgical and transcatheter treatment options are now available; however, optimal timing and procedural selection remain crucial aspects influencing outcomes. According to recent evidence in the literature, early referral is associated with good short and long-term outcomes, and various predictors of favorable outcomes following either surgical or transcatheter treatment have been identified. Evaluation by a multidisciplinary heart team with expertise in tricuspid valve disease is of paramount importance to identify adequate treatment for every patient.

Transcatheter Tricuspid Valve Replacement: Case Selection, Technical Considerations, and Procedural Planning.

Tricuspid regurgitation (TR) is a highly prevalent valve disorder in the US, with prevalence increasing with age. Without treatment, severe TR carries a poor prognosis. Tricuspid valve (TV) surgery is recommended for patients with severe TR undergoing left-sided valve surgery. Transcatheter TV repair or transcatheter TV replacement are potential options for patients who are not surgical candidates. A few small studies have demonstrated the feasibility and efficacy of transcatheter TV repair in patients with severe symptomatic TR. Careful patient selection by assessing tricuspid valve anatomy, right ventricular and pulmonary hemodynamics, candidacy for anticoagulation, comorbid conditions, and frailty is key to procedural success. Transcatheter TV repair can be performed via the transjugular or transfemoral access, and requires a large-caliber sheath (up to 45 Fr) and delivery system, particularly with dilated tricuspid annulus due to right ventricular enlargement. Multimodality imaging is essential for diagnosing TR severity, defining valve anatomy, and comprehensive functional assessment of the tricuspid valve, right atrium, and right ventricle. Several prosthetic valves, including the EVOQUE system, NaviGate system, Intrepid valve, and Cardiovalve, are currently being investigated in clinical trials.

Right Ventricular Cardiac Power Index Predicts 1 Year Outcome After Transcatheter Edge-to-Edge-Repair for Severe Tricuspid Valve Regurgitation

Tricuspid transcatheter edge-to-edge repair (T-TEER) for severe tricuspid regurgitation (TR) emerged as a novel treatment option for patients not amenable to surgery. However, knowledge regarding independent risk factors for a worse prognosis is rarely available. The study sought to investigate the impact of right ventricular cardiac power index (RVCPi) on 1-year outcomes in patients with severe symptomatic TR who underwent T-TEER. Consecutive patients with severe TR who underwent T-TEER from August 2020 to March 2022 were included and followed prospectively. Baseline clinical and invasive hemodynamic variables, changes in echocardiographic parameters and New York Heart Association functional class, and periprocedural and in-hospital major adverse events were assessed. Primary end point was defined as a composite of all-cause mortality and heart failure hospitalization at 1 year after T-TEER. A multivariable Cox proportional-hazards regression analysis was performed to identify independent risk factors for combined primary end point. RVCPi was calculated as: (cardiac index×mean pulmonary pressure)×K (conversion factor 2.22×10-3)=W/m². Receiver operator characteristic analysis was used to determine discriminative capacity of RVCPi. The prognostic value of RVCPi threshold was tested using Kaplan-Meier analysis. In total, 102 patients (mean age 81±6years, 51% women) at high operative risk underwent T-TEER for severe TR. Primary end point occurred in 30 patients (32%). Receiver operator characteristic curve analysis demonstrated that RVCPi was associated with an area under the curve of 0.69 (95% confidence interval 0.56 to 0.82; p=0.003). With a RVCPi threshold of 0.17W/m² (maximally selected rank statistics), the event-free survival was significantly higher in the RVCPi <0.17W/m² group compared with those with RVCPi ≥0.17W/m² (71% vs 35%, log-rank p<0.001). In the multivariable Cox regression analysis, RVCPi was an independent predictor for the combined primary end point (hazard ratio 2.6, 95% confidence interval 1.4 to 5.1, p=0.003). In conclusion, RVCPi is associated with outcome in patients who underwent T-TEER for severe TR and this hemodynamic predictor is useful in risk stratification of T-TEER candidates.

Comparison between multimodality imaging approaches for measurement of the tricuspid annulus in severe tricuspid regurgitation

BackgroundTricuspid valve (TV) sizing is crucial for surgical or interventional procedures planning. Imaging TV is frequently challenging and often requires multimodal imaging techniques. Computed tomography (CT) is the gold standard for sizing. The authors compared measurements of the tricuspid annulus (TA) acquired using echocardiography and CT. MethodsThirty-six patients with severe symptomatic tricuspid regurgitation were included in this retrospective analysis. During mid-diastole, the maximal two-dimensional (2D) TA diameter was directly measured in multiple views using transthoracic echocardiography (TTE) and transesophageal echocardiography (TEE). Three-dimensional (3D) TA size was assessed using cross-sectional long-axis and short-axis diameters, areas, and perimeters measured in the projected plane. The TA diameter was quantified by the perimeter measured on the CT images (CT imaging_indirect) and compared with echocardiography measurements. Tenting height and tenting area were also measured using TTE at mid systole. ResultsThe long-axis dimensions measured using 3DTEE (3DTEE_direct) best correlated with the TA diameter (CT imaging_indirect) (R = 0.851, P = 0.0001) and the least discrepancies (difference 1.2 ± 2.4 mm, P = 0.012). The TA diameters quantified by the perimeters measured using 3DTEE (3DTEE_indirect) were smaller than the CT values (difference 2.5 ± 2.5 mm, P = 0.0001). The maximal dimensions directly measured by 2DTEE (2DTEE_direct) were modestly correlated with the CT values. Overall, the maximal dimensions by TTE_direct were less reliable than those by CT. TA eccentricity index correlated with the maximal tenting height and area. ConclusionThe patients with severe tricuspid regurgitation had a dilated and circular annulus. The long-axis TA dimensions (3DTEE_direct) were similar to the diameters (CT imaging_indirect).

Transcatheter Repair for Patients with Tricuspid Regurgitation

BackgroundSevere tricuspid regurgitation is a debilitating condition that is associated with substantial morbidity and often with poor quality of life. Decreasing tricuspid regurgitation may reduce symptoms and improve clinical outcomes in patients with this disease.MethodsWe conducted a prospective randomized trial of percutaneous tricuspid transcatheter edge-to-edge repair (TEER) for severe tricuspid regurgitation. Patients with symptomatic severe tricuspid regurgitation were enrolled at 65 centers in the United States, Canada, and Europe and were randomly assigned in a 1:1 ratio to receive either TEER or medical therapy (control). The primary end point was a hierarchical composite that included death from any cause or tricuspid-valve surgery; hospitalization for heart failure; and an improvement in quality of life as measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ), with an improvement defined as an increase of at least 15 points in the KCCQ score (range, 0 to 100, with higher scores indicating better quality of life) at the 1-year follow-up. The severity of tricuspid regurgitation and safety were also assessed.ResultsA total of 350 patients were enrolled; 175 were assigned to each group. The mean age of the patients was 78 years, and 54.9% were women. The results for the primary end point favored the TEER group (win ratio, 1.48; 95% confidence interval, 1.06 to 2.13; P=0.02). The incidence of death or tricuspid-valve surgery and the rate of hospitalization for heart failure did not appear to differ between the groups. The KCCQ quality-of-life score changed by a mean (±SD) of 12.3±1.8 points in the TEER group, as compared with 0.6±1.8 points in the control group (P<0.001). At 30 days, 87.0% of the patients in the TEER group and 4.8% of those in the control group had tricuspid regurgitation of no greater than moderate severity (P<0.001). TEER was found to be safe; 98.3% of the patients who underwent the procedure were free from major adverse events at 30 days.ConclusionsTricuspid TEER was safe for patients with severe tricuspid regurgitation, reduced the severity of tricuspid regurgitation, and was associated with an improvement in quality of life. (Funded by Abbott; TRILUMINATE Pivotal ClinicalTrials.gov number, NCT03904147.)

Mitral valve TEER in the UK: what you need to know as TEER becomes routinely available in the NHS.

Transcatheter edge-to-edge repair (TEER) was first performed in 2003, and is now established across the developed world as an effective, minimally invasive treatment option for patients with mitral regurgitation (MR). Multiple large registries have established the efficacy of mitral TEER in patients with primary or degenerative MR in whom surgery is considered prohibitive or high risk, while ongoing randomised-controlled trials will determine its role in younger and lower- risk patients. In patients with secondary or functional MR, in whom mitral valve surgery is not routinely recommended, the pivotal COAPT trial showed a profound reduction in both mortality and heart failure hospitalisation in carefully selected patients. NHS England approved the routine commissioning of mitral TEER in 2019, and following a substantial delay, due in large part to the COVID pandemic, the procedure is now widely available across the UK. This review article describes the TEER procedure, currently available devices, the underlying evidence base, and the key facts needed for clinicians to understand who, how, and where to refer patients for consideration of mitral TEER. The emerging role of TEER in patients with severe symptomatic tricuspid regurgitation is also considered.

Hemodynamics of transcatheter tricuspid valve replacement with Lux-Valve.

ObjectiveTranscatheter tricuspid valve intervention (TTVI) has emerged as an alternative treatment option for high-risk and inoperable patients with symptomatic tricuspid regurgitation (TR). However, scarce data in hemodynamic profiles were available on TTVI. In this paper, we attempt to report the hemodynamic profiles of LuX-Valve.Methods30 patients from July 2020 to July 2021 were enrolled in this study. The patient was diagnosed with severe symptomatic TR. The clinical, invasive hemodynamic, and echocardiographic data were collected.ResultsThe surgical success rate was 100%. The cardiac index and stroke volume increased sharply from 2.42(2.27, 2.85) and 47.8(43.6, 62.0) to 3.04 ± 0.63 and 57.2 ± 14.7, respectively. With the elimination of TR and the increase of forward blood flow of the tricuspid valve, the extravascular lung water [798.0 (673.0, 1147.0) vs. 850.3 ± 376.1, P < 0.01] increased subsequently. The peak right atrium pressure decreased after Lux-Valve implantation (21.0 ± 6.4 vs. 19.4 ± 6.5, P < 0.05). On the contrary, the nadir right atrium pressure increased [10.0(8.0, 15.0) vs. 12.0(10.0, 17.0), P < 0.01]. Notably, the right atrium pressure difference dropped sharply from 9.0(5.0, 13.0) to 5.0(4.0, 8.0) after Lux-Valve implantation. There was no significant change in the pulmonary artery pressure. The right atrium volume decreased from 128(83, 188) to 91(67, 167) mL at 1 month and 107(66,157) mL at 6 months. With the remolding of the right heart chamber, the tricuspid annulus diameter shrank significantly from 42.5 ± 5.6 to 36.6 ± 6.3 mm at 1 month and 36.0 (33.0, 38.0) at 6 months.ConclusionInvasive right atrium pressure may act as a potential candidate for TR evaluation and procedural guidance. Elimination of TR by LuX-Valve implantation improves the cardiac output and right atrium pressure and has no significant effect on the pulmonary artery pressure even with the increment of forward blood flow, suggesting the hemodynamic superiority of transcatheter tricuspid valve replacement but needs further study.

Analysis of Cardiac Computed Tomography Anatomy in Patients With Severe Tricuspid Regurgitation Considered for Transcatheter Intervention

BackgroundSevere tricuspid regurgitation (TR) is associated with considerable morbidity/mortality in an elderly population with multiple comorbidities. There is interest in transcatheter interventions to manage severe TR. Understanding complex right heart (RH) geometry and tricuspid valve shape and size has implications for patient/device selection for transcatheter intervention. We characterized RH anatomy by computed tomography in patients with symptomatic severe TR considered for intervention. MethodsThe retrospective Mayo Clinic study included 29 patients with an echocardiogram and cardiac computed tomography angiogram considered for intervention of severe TR from March 01, 2016 to December 15, 2020. Patients were divided into 2 groups: intervention (surgical or transcatheter; n = 17) and medical management alone (n = 12). ResultsMean age was 83 ± 8 (83% female), 100% had atrial fibrillation, and 62% had chronic kidney disease ≥3a. Ninety-seven percent were symptomatic, 93% had been prescribed loop diuretics, and 24% had device leads. Mean tricuspid annular plane systolic excursion was 16.8 ± 4.5 mm, effective regurgitant orifice area was 81 ± 33 mm2, and cardiac index was 2.6 ± 0.6 L/min/m2. Forty-one percent had at least moderate right ventricular (RV) dysfunction with a mean RV systolic pressure of 46 ± 16 mmHg. Patients receiving intervention had significantly larger effective regurgitant orifice area (101 ± 33 vs. 63 ± 22 mm2, p = 0.033), shorter tricuspid leaflet tenting length (6.5 ± 3.0 vs. 8.9 ± 2.7 mm, p = 0.042), and smaller annuloplasty diagnostic perimeter during diastole (120.1 ± 16.6 vs. 131.1 ± 7.4 mm, p = 0.041). Intervention patients tended to have better right ventricular function, smaller RV and inferior vena cava size, and more severe symptoms. The maximal tricuspid annulus diameter in systole and diastole was 51 ± 5 and 53 ± 7 mm, respectively. ConclusionsSevere TR patients referred for transcatheter intervention present with severe RH enlargement with a large proportion having tricuspid annulus dimensions outside the range for current devices available in clinical trials. The presented data have implications for device development/selection and procedural feasibility.

Novel treatment of atrial functional tricuspid regurgitation using transcatheter bicaval valve implantation (TricValve).

Transcatheter tricuspid valve intervention has recently emerged as a viable alternative to surgery for patients with symptomatic severe tricuspid regurgitation (TR). Though usually performed on the basis of compassionate grounds, we are now exploring the extension of its usage as an elective option in a patient with severe atrial functional tricuspid regurgitation. The aim of this study was to select a suitable patient and proceed with the implantation of the TricValve in order to provide symptomatic relief as well as to improve morbidity and mortality. A 67-year-old woman had underlying atrial fibrillation and severe tricuspid regurgitation. Despite optimised medical therapy, she remained symptomatic with elevated NT-proBNP levels. As the patient refused surgery on multiple occasions, we chose a percutaneous procedure guided by transoesophageal echocardiography and fluoroscopy. The procedure was uneventful and the patient was discharged. At 3-month follow-up, there was marked improvement clinically and biochemically. Bicaval valve implantation with the TricValve is a viable alternative to surgery in patients with symptomatic severe tricuspid regurgitation. This intervention is crucial as we are now able to intervene before irreversible right ventricular dysfunction sets in.

6-Month Outcomes of the TricValveSystem in Patients With Tricuspid Regurgitation: The TRICUS EURO Study.

Severe tricuspid regurgitation (TR) is frequently associated with significant morbidity and mortality; such patients are often deemed to be at high surgical risk. Heterotopic bicaval stenting is an emerging, attractive transcatheter solution for these patients. The aim of this study was to evaluate the 30-day safety and 6-month efficacy outcomes of specifically designed bioprosthetic valves for the superior and inferior vena cava. TRICUS EURO (Safety and Efficacy of the TricValve® Transcatheter Bicaval Valves System in the Superior and Inferior Vena Cava in Patients With Severe Tricuspid Regurgitation) is a nonblinded, nonrandomized, single-arm, multicenter, prospective trial that enrolled patients from 12 European centers between December 2019 and February 2021. High-risk individuals with severe symptomatic TR despite optimal medical therapy were included. The primary endpoint was quality-of-life (QOL) improvement measured by Kansas City Cardiomyopathy Questionnaire score and New York Heart Association (NYHA) functional class improvement at 6-month follow-up. Thirty-five patients (mean age 76 ± 6.8 years, 83% women) were treated using the TricValve system. All patients at baseline were in NYHA functional class III or IV. At 30days, procedural success was 94%, with no procedural deaths or conversions to surgery. A significant increase in QOL at 6months follow-up was observed (baseline and 6-month Kansas City Cardiomyopathy Questionnaire scores 42.01 ± 22.3 and 59.7 ± 23.6, respectively; P=0.004), correlating with a significant improvement in NYHA functional class, with 79.4% of patients noted to be in functional class I or II at 6months (P=0.0006). The rates of 6-month all-cause mortality and heart failure hospitalization were 8.5% and 20%, respectively. The dedicated bicaval system for treating severe symptomatic TR was associated with a high procedural success rate and significant improvements in both QOL and functional classification at 6months follow-up.

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

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

Transfemoral tricuspid valve-in-ring implantation: Approach to a challenging clinical scenario

Transcatheter tricuspid valve-in-ring (TVIR) implantation using balloon-expandable valve was an alternative technic to high-risk redo surgery for patients with tricuspid valve (TV) ring repair and symptomatic severe tricuspid regurgitation. In this case, we report a case of unsuccessful transfemoral TVIR implantation with a severe paravalvular leak (PVL) treated successfully with Amplatzer vascular plug.

Early Clinical Experience With the TRICENTO Bicaval Valved Stent for Treatment of Symptomatic Severe Tricuspid Regurgitation: A Multicenter Registry.

Patients with severe tricuspid regurgitation present late and are often ineligible for surgery or transcatheter repair systems. Transfemoral venous implantation of a bicaval valved stent has been proposed as therapeutic option in selected patients. The aim of this study was to summarize the early procedural and clinical outcomes of the novel TRICENTO system for the treatment of patients with symptomatic severe tricuspid regurgitation. All consecutive patients treated with the custom-made TRICENTO implant at the participating centers were included in this retrospective multicentre registry. A total of 21 high-risk patients (mean age 76±7 years; 67% female) with severe or higher grade tricuspid regurgitation were analyzed. The majority of the patients were in New York Heart Association class III/IV (95%), had peripheral edema (95%), and previous hospitalization for right heart failure (67%). Technical success was 100%, and there was no case of in-hospital mortality. During follow-up (median 61 days), symptomatic improvement was observed (65% in New York Heart Association class I/II; P<0.001). Computed tomography revealed asymptomatic fractures of the TRICENTO prosthesis in 3 patients. Cardiac magnetic resonance imaging obtained in 7 patients showed a significant decrease (252±65 mm3 at baseline versus 216±58 mm3 at follow-up, P=0.006) of right ventricular end-diastolic volume. The overall-survival rate was 76% at 1 year. The present data indicate the feasibility of transfemoral bicaval valved stent implantation for the treatment of severe tricuspid regurgitation. Functional improvement and signs of right ventricular reverse remodeling were observed. Stent fractures did not impair valve function, but require refinement of prosthesis design and careful assessment of eligibility criteria.

757 Cardio-TC role in patients selection for transcatheter edge to edge tricuspid repair

Abstract Aims Anatomic knowledge of the tricuspid valve (TV) is the first step in the management of patients with tricuspid regurgitation (TR) who are candidates for transcatheter tricuspid valve intervention (TTVI). Echocardiography is undoubtedly the first approach in assessing the aetiology and severity of TR and the size and function of the right chambers. Computed tomography (CT) provides a detailed morphological visualization of the cardiac structures owing to acquisition of 3D data with high spatial resolution. These findings may undoubtedly help in decision-making progress for novel transcatheter therapies. The purpose of the present study was to assess the geometrical changes of the TV complex using CT images, in patients suffering from functional TR and lead-induced TR. Methods The study population consisted of 21 consecutive patients with symptomatic severe TR referred to Policlinico Universitario Campus Biomedico between November 2020 and October 2021. Patients were prospectively included in the study only if they presented severe TR, diagnosed by echocardiography and underwent cardiac CT study dedicated to the right-chambers. The reconstructions were transferred to an external workstation for off-line image analysis. The following measurements were reported: tricuspid annulus area, perimeter, septal–lateral and antero-posterior diameters. Commissures were identified as antero-septal (AS), postero-septal (PS) and anteroposterior (AP). Were measured the inferior vena cava ostium to tricuspid valve centroid distance, anatomic regurgitant orifice area (AROA) and its position respect to the centroid, and the right chambers. Results All 21 patients underwent CT scan using Siemens SOMATOM Definition AS 128 Slice CT Machine. The measurements were calculated off-line using the 3mensio workstation. In our study population, the annulus resulted enlarged in the annulus area, perimeter, septal-lateral and anterior-posterior dimensions. Measurements did not differ significantly, except for the septal-lateral diameter that was smaller in systole (52.80 ± 7.28 mm vs. 47.83 ± 6.83 mm (P=0.027). Also, distances between the commissures were similar except for the AP-AS distance that was shorter in systole (45.26 ± 3.48 mm vs. 42.13 ± 3.73, P=0.007). The AROA resulted to be central in 7 patients, the IVC ostium to TV centroid distance was 23±3 mm. Right chambers and IVC resulted very enlarged in all patients. Conclusions CT provides a complete morphologic imaging of the heart structures, thanks to a high spatial resolution with excellent capacity to define the endocardial border and allows acquisition of three-dimensional data with high spatial resolution of the TV and provides valuable information about the geometric variations of the tricuspid complex in patients with TR. Image quality for analysis should be optimized with specific CT acquisition protocols that focus on the right ventricles.

Transcatheter Tricuspid Valve Therapy: From Anatomy to Intervention.

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