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
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