Transcatheter Tricuspid Valve Clinical Trials: Incomplete Data and FDA-Approved Devices

Figures

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  Figure 1. Investigational and commercial devices for transcatheter tricuspid valve repair or replacement. From left to right, the EVOQUE tricuspid valve replacement system, the TriClip transcatheter tricuspid valve repair system, and the PASCAL transcatheter valve repair system.

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  Figure 2. Construct of the TRISCEND II Trial Data Analysis Plan. This figure illustrates the 2-phase design of the TRISCEND II pivotal trial, which consists of 30-day safety and 6-month effectiveness endpoints for the first 150 patients, followed by a hierarchical composite endpoint of 1-year safety and effectiveness for the full 400-patient cohort in the second phase. https://www.accessdata.fda.gov/cdrh_docs/pdf23/P230013B.pdf.

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  Figure 3. TRISCEND II all-cause mortality. This figure demonstrates the 1-year mortality results of the modified intention to treat population in TRISCEND II (all patients who had a study device attempted in the device group or who were randomized to the control group). Procedural hazard crosses at approximately 9 months, yielding a survival advantage with patients receiving the EVOQUE valve by 18 months. https://www.accessdata.fda.gov/cdrh_docs/pdf23/P230013B.pdf. Abbreviation: mITT, modified intention to treat.

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  Figure 4. TRILUMINATE: Win ratio analysis of primary endpoint for sites that enrolled >10 subjects. This figure illustrates the favorable win ratio in the TEER group as compared with medical therapy. The primary endpoint 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 KCCQ. The win ratio analysis favored the TEER group in both the composite primary endpoint and each of its individual components. FDA Comment: The win ratio result of the primary endpoint for the group of sites that enrolled > 10 patients was more than two-fold higher vs. the group of sites that enrolled <10 patients. https://www.fda.gov/media/176088/download. Abbreviations: HFH, heart failure hospitalizations; KCCQ, Kansas City Cardiomyopathy Questionnaire; TEER, transcatheter edge-to-edge repair; TV, tricuspid valve.

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  Figure 5. Association between KCCQ score and TR at 12 months. This figure illustrates the association between TR reduction and improvement in quality of life, as demonstrated in TRILUMINATE. Patients saw the greatest improvement in quality of life when TR was reduced by +2 grades (https://www.fda.gov/media/176088/download). Abbreviations: KCCQ, Kansas City Cardiomyopathy Questionnaire; TR, tricuspid regurgitation.

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  Figure 6. TR treatment algorithm. This figure illustrates a proposed algorithm for treating patients with severe TR. If present, LV dysfunction and valvular disease should be treated. Patients should then be medically optimized with diuretics and SGLT2i inhibitors, targeting a wedge pressure of less than 20 mmHg. If patients have severe pulmonary hypertension, they should be excluded from the treatment algorithm. If patients continue to have symptoms or signs of RV failure, surgical candidacy should be considered. For intermediate- or high-risk surgical patients, transcatheter therapies are appropriate. These patients are then subdivided by coaptation gap. Patients with a coaptation gap < 7 mm are better suited for TEER. TTVR is appropriate for intermediate- or high-risk surgical patients with large coaptation gaps. Caval valve implantation should be reserved for patients with acoustic shadowing, anatomic exclusions, or failed T-TEER. Abbreviations: LV, left ventricle; OAC, oral anticoagulant; PCM, permanent pacemaker; PCWP, pulmonary capillary wedge pressure; PVR, pulmonary vascular resistance; RV, right ventricle; SGLT2i, sodium/glucose cotransporter-2 inhibitor; TEER, transcatheter…