Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Abbott Background As tricuspid transcatheter edge-to-edge repair (TEER) gains momentum, the proper measurement of coaptation gap to determine optimal patients for this therapy becomes increasingly important. Currently, a single septo-lateral measurement from the short-axis transgastric (SAX TG) or RV inflow/outflow biplane view is commonly used as the representative coaptation gap measurement for a patient. However, this measurement is not necessarily performed at the intended location for TEER and may overestimate the coaptation gaps to be treated. Purpose To characterize the coaptation gap in patients receiving tricuspid TEER which may provide insights on how to best determine eligibility for edge-to-edge repair. Methods bRIGHT is a prospective, multi-center, single arm post-market study evaluating the safety and effectiveness of the TriClip device in symptomatic patients with severe tricuspid regurgitation. Detailed echocardiographic coaptation gap measurements were performed on the first 46 subjects with available echo data by two experienced echocardiographers. Coaptation gap was measured at four levels in the SAX TG view (Figure 1) and also at the resulting long axis view from a orthogonal view taken from a RV inflow/outflow view obtained at the anterior, mid and posterior aspect of the tricuspid valve (Figure 2). Results The biplane RV inflow/outflow and SAX TG views were available in 91% (42/46) and 93% (43/46) of subjects, respectively. From the SAX TG view, coaptation gap measured 9.0 ± 3.9 and 4.9 ± 2.7 mm in the central and mid regions of the anterior-septal coaptation line, and 7.6 ± 3.4 and 4.0 ± 2.1 mm in the central and mid regions of the septal-posterior coaptation line (Figure 1). The largest coaptation gap presented between the anterior and septal leaflets in 78% (33/43) of subjects, with the gap extending across the anterior-septal and septal-posterior coaptation lines in 98% (42/43) of subjects. Coaptation gap measured 6.2 ± 2.8, 6.6 ± 2.8 and 6.0 ± 3.5 mm in the anterior, mid and posterior aspects of the RV inflow/outflow view (Figure 2). In subjects with both views available, the SAX TG view resulted in larger coaptation gap measurements (+3.4 ± 3.0 mm) in 95% (38/40) of subjects. A significant, positive correlation was observed between the maximum biplane and transgastric measurements (rho = 0.648, p < 0.0001). Conclusion A single septo-lateral measurement may overestimate the actual gap size and potentially exclude patients who are viable candidates for TEER. Measurements in both the SAX TG and RV inflow/outflow biplane should be taken into account when determining appropriateness of a given anatomy for tricuspid TEER Future work in larger cohorts is needed to determine which coaptation gap measurements are predictive of procedural outcomes and how these measurements may influence treatment strategy. Abstract Figure 1 Abstract Figure 2
Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Abbott Background Tricuspid regurgitation (TR) is a frequent disease with a graded increase in mortality as disease severity increases. The TriClip tricuspid valve repair system (TVRS) recently gained CE mark approval in March 2020 as a transcatheter treatment option for severe TR. The bRIGHT study was initiated to evaluate real-world safety and efficacy in patients treated with the TriClip TVRS and gather data to better understand these patients and this disease. Purpose To report real-world, core lab adjudicated changes in TR severity and echocardiographic parameters from baseline through 30-day follow-up in subjects treated with tricuspid transcatheter edge-to-edge repair (TEER). Methods bRIGHT is a prospective, multi-center, single arm post-market study evaluating the safety and effectiveness of the TriClip device in symptomatic patients with severe TR. Detailed echocardiographic assessment was performed on all available echo data for the first 175 enrolled subjects by an independent echo core lab. TR was categorized using a 5-grade scale, with the traditional "severe" grade further characterized as severe, massive and torrential. Results At baseline, TR was "severe" in 98% (143/146) of subjects, which further stratifies to severe in 9% (13/146), massive in 63% (92/146) and torrential in 26% (38/146) of subjects using the 5-grade scale. At 30 days, TR was reduced by ≥1 grade in 81% of subjects, with 70% of subjects at moderate or less residual TR compared to only 1% at baseline (p < 0.0001, Figure 1). Vena contracta width decreased from 0.79 ± 0.56 mm at baseline to 0.41 ± 0.37 mm at 30 days. Effective regurgitant orifice (EROA) area decreased from 0.87 ± 0.57 cm2 at baseline to 0.38 ± 0.25 cm2 at 30-days. Similarly, regurgitant volume, PISA radius and jet area showed significant reductions (Table 1). RV end diastolic dimension decreased from 4.70 ± 0.85 cm at baseline to 4.22 ± 0.83 cm at 30 days. No changes were observed in right atrial volume or right ventricular function. Subjects were treated with 1.9 ± 0.7 clips on average, with less than a 1 mmHg increase in mean tricuspid valve gradient; average gradient was 1.12 ± 0.65, 1.92 ± 1.15 and 1.97 ± 1.81mm Hg at baseline, discharge and 30 days respectively. Tricuspid annular diameter was significantly higher in subjects with torrential TR at baseline compared to subjects with severe or massive TR (p < 0.001). Conclusions Tricuspid TEER with the TriClip device showed significant reduction in TR severity in a real-world setting. Significant reduction were seen in vena contracta width, PISA radius, EROA, regurgitant volume and jet area among others. The majority of patients had massive TR at baseline. Future studies in larger cohorts are needed to investigate the relationship between the extent of TR reduction and clinical outcomes. Abstract Figure 1 Abstract Table 1
Funding Acknowledgements Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Trial funded by Abbott Background As the treatment of tricuspid regurgitation with tricuspid transcatheter edge-to-edge repair (TEER) becomes more widespread, a better understanding of tricuspid anatomy is increasingly important to properly select patients for this therapy. The diversity of tricuspid anatomies in the real-world population is not well known, and strategies for characterization of some anatomic features are not well defined. Purpose To propose a method to accurately and consistently characterize the tricuspid valve anatomy with transthoracic and transesophageal echo in patients receiving tricuspid TEER and investigate the diversity of tricuspid valve anatomies reflected in a real-world population. Methods The bRIGHT trial is a prospective, single-arm, multi-center registry initiated to evaluate the safety and effectiveness of the TriClip transcatheter edge-to-edge repair (TEER) System in patients with severe tricuspid regurgitation (TR) in a real-world post-market setting. Detailed echocardiographic analysis was performed on subjects from 25 sites with available baseline echo. Subjects were evaluated for three key anatomical factors that are anticipated to be critical in determining the feasibility of TEER: number of tricuspid valve leaflets, degree of leaflet restriction, and coaptation gap size. Herein, we present a proposed method for characterizing these factors through echo analysis. Results Between August 2020 and July 2022, 312 patients subjects (age, 78.4±7.6 years, 54% women) at 25 sites were enrolled into the bRIGHT trial and 283 subjects had available baseline echo. Coaptation gap size was measured at the largest clippable location (Figure 1) and was found to range from 2.3 mm to 20.8mm (avg. 8.6 ± 3.3 mm). According to the analysis method proposed by Hahn et. Al, the majority of subjects were found to have 3 leaflets (80%), however 4 and 5 leaflet anatomies were also present (20% and 1% respectively). Severity of leaflet restriction was categorized according to a 4-grade scale. In the subjects studied, restriction severity ranged from none to severe, with 21% of subjects having no restriction, 65% displaying mild restriction, 12% displaying moderate restriction, and 2% severe restriction. Conclusions In this analysis of 283 subjects treated as part of the bRIGHT trial, a proposed method to accurately and consistently characterize the tricuspid valve anatomy from baseline echo was developed. The method reaved the broad range of tricuspid valve anatomies realized in this real-world population. ___________________________________
Background As tricuspid transcatheter edge-to-edge repair (TEER) gains momentum, a better understanding of coaptation gap size and location becomes increasingly important to properly select patients for this therapy. The tricuspid valve is complex and patient phenotypes may be highly variable. It is currently unknown how location of the coaptation gap may impact procedural strategy and clinical outcomes. Purpose To characterize the coaptation gap in patients receiving tricuspid TEER and investigate the effect of coaptation gap location on procedural strategy and short-term outcomes. Methods bRIGHT is a prospective, multi-center, single arm post-market study evaluating the safety and effectiveness of the TriClip device in symptomatic patients with severe tricuspid regurgitation. Detailed echocardiographic coaptation gap measurements were performed on 135 subjects (from 24 sites) with available echo. Procedural and short-term outcomes were stratified by coaptation gap location. Results The biplane RV inflow/outflow and short-axis transgastric (SAX TG) views were available in 90% (122/135) and 56% (76/135) of subjects, respectively. From the SAX TG view, coaptation gap measured 8.2±3.4 and 5.2±2.4 mm in the central and mid regions of the anterior-septal (AS) coaptation line, and 6.5±3.0 and 3.7±2.0 mm in the central and mid regions of the septal-posterior (SP) coaptation line (Figure 1). Coaptation gap measured 4.7±2.4, 5.2±2.4 and 4.6±3.0 mm in the anterior, mid and posterior aspects of the RV inflow/outflow view. The largest coaptation gap presented in the AS region in 79% (95/120) of subjects. A comparison of baseline characteristics, procedural strategy and outcomes stratified by location of the largest coaptation gap is provided in Table 1. Annulus and right ventricle size and presence of pacemakers were similar between groups. Torrential TR at baseline was more common in the SP group. Clipping strategy was similar with the majority of implants placed in the AS region. Implant success and acute procedural success (APS) were achieved in the majority of patients in both groups, with the SP group showing higher APS rates, 96% vs 85%, respectively. At 30-day follow-up, subjects with the largest gap in the SP region experienced more TR reduction at 30-day follow-up, 2.8±1.6 vs 2.1±1.3 grade reduction, respectively. Clinical improvements were observed in both groups: KCCQ increased by more than 15 points on average and the majority of subjects in both groups were NYHA I/II at 30-day follow-up. Conclusion Coaptation gap size varies across the tricuspid valve and measurements at the intended clipping location should be taken into account when determining appropriateness of a given anatomy for tricuspid TEER. TriClip TEER offered high rates of implant and procedural success and improved clinical outcomes regardless of coaptation gap location. Subjects with SP coaptation gap localization are infrequent but should not be excluded from TEER therapy. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Abbott
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