Highlights
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Unsuitability rate for TTVR is lower than previously reported (∼17%).
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Large annular dimensions are the leading reason for ineligibility.
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T-TEER reduces TR in ineligible patients, but residual regurgitation is common.
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Alternative percutaneous therapies are needed for this high-risk group.
Transcatheter tricuspid valve replacement (TTVR) has shown therapeutic promise for patients with severe tricuspid regurgitation (TR). However, some patients may not be eligible due to anatomic limitations. We sought to describe the outcomes of patients who were referred for transcatheter tricuspid valve intervention (TTVI) and were ineligible for TTVR. This was a single-center, retrospective study of 251 patients referred for TTVI from February 2024 to August 2025. All patients were considered by a multidisciplinary heart team and assessed for feasibility of commercial tricuspid valve repair or replacement, with a strategy to proceed with replacement if anatomically feasible. Data on demographics, clinical characteristics, and outcomes were collected from medical records. Of 251 patients evaluated, 43 (17.1%) were unsuitable for TTVR. Compared with suitable patients, unsuitable patients were more frequently male (67.4% vs 33.2%, p <0.01) and more likely to have implanted electronic device (53.5% vs 32.2%, p = 0.01) or prior tricuspid interventions (7.9% vs 1.6%, p = 0.03). The leading reason for unsuitability was large annular dimensions (60.5%), followed by leaflet tethering (14.0%) and small annular size (11.6%). Of the unsuitable cohort, 10 patients (23.3%) underwent T-TEER and 33 (76.7%) received medical therapy alone. T-TEER resulted in significant reduction in TR severity (p = 0.034), though 80% had residual moderate or greater TR. In conclusion, this commercial experience, rates of TTVR ineligibility were lower than previously described with large annular dimensions serving as the most frequent exclusion criterion. For those ineligible, T-TEER may provide a feasible approach in appropriately selected patients.
Graphical Abstract
Severe tricuspid regurgitation (TR) is a challenging condition associated with significant morbidity and >36% 1-year mortality. , Previously, it was characterized by low rates of surgical intervention due to patient co-morbidities and late referrals, and hence a high percentage of patients assigned to medical therapy. With the advent of percutaneous options, specifically transcatheter tricuspid valve replacement (TTVR) and transcatheter tricuspid edge-to-edge repair (T-TEER), many of these previously untreatable patients may be candidates for intervention. With no head-to-head trials of the 2 currently available technologies (Evoque and Triclip), the decision of which therapies are best for which patients is usually at the discretion of the individual heart teams.
Transcatheter tricuspid valve replacement with the Evoque system is the only device currently commercially approved for TTVR in the United States. Although rates of residual TR are low, factors such as excessively large or small annular dimensions, significant leaflet tethering, and the presence of trans-tricuspid leads or implantable cardiac defibrillators may preclude implantation. In fact, previous studies of patients who were evaluated as part of a clinical trial of TTVR have suggested that up to 74% of patients who were screened may be ineligible. As clinical trials have strict inclusion and exclusion criteria, it remains unclear if this percentage may be accurate in an all-comers population. We sought to describe the outcomes of patients who were referred for transcatheter tricuspid valve intervention (TTVI) and were deemed anatomically ineligible for TTVR.
Methods
This was a single-center, retrospective cohort study of 251 patients who were referred for consideration of TTVI from February 1, 2024, to February 1, 2025. All patients had severe symptomatic TR and underwent a comprehensive evaluation by a multidisciplinary heart team. During multidisciplinary discussion, all potential treatment strategies, including surgical intervention, transcatheter options, and medical therapy, are considered. In addition to the 251 patients evaluated for feasibility of TTVR, 5 patients underwent T-TEER without prior CT-based TTVR screening. These cases were primarily driven by contraindications to anticoagulation and/or advanced kidney disease, where contrast administration was avoided. Although the exact number of patients who ultimately underwent surgical tricuspid valve intervention is unknown, it is estimated to be less than 1%, primarily in cases with concomitant left-sided valvular disease or the need for surgical coronary revascularization. Furthermore, approximately 25% of patients were deemed ineligible for TTVR at the initial screening stage due to intolerance to anticoagulation.
The candidacy of patients for both therapies, repair and replacement was considered, with tricuspid valve replacement being the preferred initial approach. All patients were submitted to the manufacturer of the Evoque valve (Edwards Lifesciences, Irvine, CA) for final adjudication of suitability for implantation. Based on the manufacturers and internal team’s assessment, patients who were deemed unsuitable for TTVR either underwent T-TEER using the TriClip Tricuspid valve repair system (Abbott, Santa Clara, CA) or were managed with medical therapy alone.
Demographic data, clinical characteristics, and outcome information were collected through a comprehensive review of electronic medical records. Information extracted included age, sex, comorbidities, prior interventions, TR severity, and Kansas city cardiomyopathy questionnaire (KCCQ) scores. Follow-up data were gathered from outpatient visits, hospital records, and echocardiographic reports. Echocardiographic parameters, including regurgitation grades and right ventricular dysfunction (RVD), are reported numerically as follows: TR: 0, none/trace; 1, mild; 2, moderate; 3, severe; 4, massive; 5, torrential. Mitral regurgitation (MR): 0, none/trace; 1, mild; 2, moderate; 3, severe. RVD: 0, none/trace; 1, mild; 2, moderate; 3, severe.
Continuous variables are expressed as mean ± SD and were compared with an independent two-tailed t-test. Categorical variables are expressed as number (percentage) and compared using chi-square test. Tricuspid regurgitation, MR, and RVD are presented in numerical form ± SD and compared with Mann Whitney U-Test.
The methodology of this study was reviewed and approved by the Henry Ford Health Institutional Review Board, ensuring compliance with ethical guidelines and patient confidentiality.
Results
Of the 251 patients evaluated, 43 (17.1%) were deemed anatomically unsuitable for TTVR with the Evoque system, Figure 1 . Baseline characteristics of patients stratified by anatomical suitability are shown in Table 1 . The mean age was similar between suitable (76.6 ± 10.3 years) and unsuitable patients (76.5 ± 11.3 years, p = 0.97). However, sex distribution differed significantly, with unsuitable patients more frequently male (67.4% vs 33.2%, p <0.01). The prevalence of comorbidities, including hypertension, hyperlipidemia, diabetes, atrial fibrillation or flutter, chronic kidney disease, and prior coronary revascularization, was comparable between groups. A numerically higher proportion of unsuitable patients had a prior stroke (23.3% vs 13.0%, p = 0.08) and liver disease (23.3% vs 14.4%, p = 0.15), though these did not reach statistical significance. Other clinical and functional parameters, including BMI, New York Heart Association (NYHA) class, KCCQ composite scores, and society of thoracic surgeons (STS) mortality risk, were not significantly different between groups.
Management flowchart. A total of 251 patients were evaluated for TTVI. Of these, 208 were deemed suitable for TTVR. Among the 43 patients considered unsuitable for TTVR, 33 were managed medically, and 10 underwent T-TEER.
Table 1
Baseline demographics
| Suitable (n = 208) | Unsuitable (n = 43) | p-value | |
|---|---|---|---|
| Age (years) | 76.6 ± 10.3 | 76.5 ± 11.3 | 0.966 |
| Sex (Male) | 69 (33.2%) | 29 (67.4%) | <0.001 |
| Race | |||
| White | 165 (79.3%) | 38 (88.4%) | 0.170 |
| Black | 37 (17.8%) | 5 (11.6%) | 0.325 |
| Asian | 2 (1.0%) | 0 (0.0%) | 0.519 |
| Indian | 1 (0.5%) | 0 (0.0%) | 0.649 |
| Hispanic | 3 (1.4%) | 0 (0.0%) | 0.428 |
| Body mass index (kg/m 2) | 28.3 ± 6.3 | 27.1 ± 4.9 | 0.221 |
| New York Heart association functional class | 2.79 ± 0.59 | 3.00 ± 0.60 | 0.467 |
| Kansas city cardiomyopathy questionnaire composite score | 48.3 ± 23.7 | 48.4 ± 24.9 | 0.985 |
| Society of thoracic surgeons’ mortality risk (Mitral valve replacement as surrogate) | 15.4 ± 10.2 | 15.67 ± 8.7 | 0.929 |
| Atrial fibrillation/Atrial flutter | 168 (80.8%) | 34 (79.1%) | 0.798 |
| Hyperlipidemia | 145 (69.7%) | 28 (65.1%) | 0.553 |
| Hypertension | 175 (84.1%) | 36 (83.7%) | 0.946 |
| Stroke | 27 (13.0%) | 10 (23.3%) | 0.084 |
| Diabetes | 46 (22.1%) | 6 (14.0%) | 0.229 |
| Chronic kidney disease | 142 (68.3%) | 29 (67.4%) | 0.916 |
| Glomerular filtration rate (ml/min/1.73m 2) | 51.7 ± 23.2 | 53.2 ± 24.8 | 0.716 |
| Liver disease | 30 (14.4%) | 10 (23.3%) | 0.150 |
| Chronic obstructive pulmonary disease | 70 (33.7%) | 9 (20.9%) | 0.102 |
| Peripheral arterial disease | 33 (15.9%) | 7 (16.3%) | 0.946 |
| Myocardial infarction | 18 (8.7%) | 4 (9.3%) | 0.891 |
| Coronary artery bypass grafting | 32 (15.4%) | 7 (16.3%) | 0.883 |
| Percutaneous coronary intervention | 35 (16.9%) | 8 (18.6%) | 0.778 |
| Tricuspid transvalvular device | 67 (32.2%) | 23 (53.5%) | 0.008 |
| Previous valvular intervention | |||
| Aortic valve | 34 (17.6%) | 10 (26.3%) | 0.278 |
| Mitral valve | 43 (22.3%) | 9 (23.7%) | 0.970 |
| Tricuspid valve | 3 (1.55%) | 3 (7.9%) | 0.031 |
| Pulmonary valve | 2 (1.04%) | 0 (0.0%) | 0.519 |
| Brain natriuretic peptide (pg/ml) | 1055 ± 1521 | 899 ± 898 | 0.538 |
| Left ventricular ejection fraction (%) | 53.8 ± 12.0 | 50.2 ± 10.9 | 0.083 |
| Tricuspid regurgitation grade | 3.01 ± 0.59 | 3.19 ± 0.73 | 0.134 |
| Mitral regurgitation grade | 1.18 ± 0.83 | 1.50 ± 0.86 | 0.031 |
| Right ventricular dysfunction | 0.79 ± 0.92 | 1.07 ± 1.00 | 0.046 |
| Pulmonary artery systolic pressure (mm Hg) | 45.4 ± 14.2 | 37.5 ± 10.6 | 0.001 |
| Tricuspid annular plance systolic excursion (cm) | 1.74 ± 0.50 | 1.86 ± 0.65 | 0.242 |
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