All data were obtained from the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) transcatheter valve therapies (TVT) registry, which introduced a dedicated tricuspid data collection form in January 2021. The registry contains patient characteristics, echocardiographic data, procedural details, 30-day and 1-year outcomes, including health status as measured by the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) for off-label commercially performed TTVI. TTVIs performed as part of an investigational device exception clinical trial are not included in the registry. The registry undergoes annual data quality and completeness checks via the National Cardiovascular Data Registry and Duke Clinical Research Institute, including a random 10% third-party data audit. The TVT registry is approved by the central IRB Advarra and analyses are approved by the Institutional Review Board of Duke University (IRB#: Pro00040634) with patient consent waived.

All patients undergoing TTVI from January 2021 through December 2023 were identified in the TVT registry. In order to investigate outcomes of off-label devices used for TTVI, this analysis was limited to interventions prior to 2024, when the FDA approved both TTVR and T-TEER devices. As the analysis was focused on patients undergoing TTVR and T-TEER for TR, patients who had isolated tricuspid stenosis, <moderate TR, and isolated transcatheter annular reduction procedures were excluded. Also, patients undergoing concomitant nontricuspid transcatheter valve procedure were excluded to avoid confounding from nontricuspid interventions. No patients enrolled in concurrent clinical trials were included in this analysis. All descriptive data and outcomes are presented stratified by TTVR and T-TEER subpopulations.

The primary outcomes were residual TR severity and change in KCCQ-OS at 30 days. TR was graded by sites per the 4-grade American Society of Echocardiography grading system (none/trivial, mild, moderate, severe). Change in KCCQ-OS from preprocedure to 30-days was assessed as an established categorical change, ^, including significantly improved (>20 points), moderately improved (10-20 points), mildly improved (5-10 points), no change (5 point decrease to 5 point increase) and worse (greater than 5 point decrease). Additional 30-day outcomes included mortality, conversion to open heart surgery, device embolization, new permanent pacemaker (PPM), major vascular complications, major, life threatening or disabling bleeding event, heart failure readmission, and tricuspid valve reintervention. Mortality over 1 year after TTVI was also assessed.

The statistical analysis was primarily descriptive with categorical variables presented as number and frequency and continuous variables presented as mean and standard deviation or median and interquartile range. 1-year time-to-event mortality was presented with the Kaplan–Meier approach. KCCQ-OS analysis was limited to sites with at least 50% completeness for 30-day KCCQ-OS data (Supplemental Table 1). An inverse probability weighting model was developed to estimate the probability of having a missing KCCQ-OS outcome, adjusting for baseline KCCQ-OS and other baseline characteristics listed in Supplemental Table 1. Given the differential anatomic requirements and expected reductions in TR between TTVR and T-TEER, all analyses are stratified by procedure type, and comparisons of outcomes were intentionally not undertaken. In order to assess how echocardiographic results of T-TEER (reduction in TR) are associated with improvement in quality of life, categorical changes in KCCQ-OS and residual TR were compared. The Cochran–Mantel–Haenszel test was used to assess for potential association between residual TR and changes in KCCQ-OS. All statistics were performed in SAS version 9.4 (Cary, NC, USA) at the Duke Clinical Research Institute.

There were a total of 142 institutions that performed at least one commercial, off-label TTVI during the study period. The majority (71.8%) of institutions performed 5 or fewer TTVI ( Figure 1 ), and 50 (35.2%) institutions only performed 1 procedure. Higher volume institutions included 12 institutions performing 11-20 TTVI and 5 institutions performing 21 to 40 TTVI. There were 4 very-high volume institutions performing 49, 81, 94, and 120 TTVI procedures during the study period.

Histogram of institutional TTVI volume.

There were 238 TTVR procedures ( Figure 2 ), of which the majority were valve-in-valve procedures (69.7%, N = 166). Median age was 60 years (IQR 41-74), and 64.7% ( N = 105) were female ( Table 1 ). TTVR patients presented with a very high comorbidity burden, including 59.7% ( N = 142) with atrial fibrillation, 38.7% ( N = 70) with a heart failure hospitalization in the past year, and 14.3% ( N = 34) with prior stroke. 11.8% ( N = 29) had prior surgical aortic valve replacement, and 29.8% ( N = 71) prior surgical mitral valve repair/replacement. Baseline health status was poor; 37.6% ( N = 65) had poor to fair KCCQ-OS score (25-49.9) and 34.1% ( N = 59) had very poor KCCQ-OS (<25). Baseline echocardiogram and hemodynamic status is summarized in Table 2 , and procedural details are summarized in Table 3 .

Study flow diagram.

Table 2

Baseline echocardiogram and hemodynamic status.

Variable	Replacement (TTVR) ( N = 238)	Repair (T-TEER) ( N = 757)
Tricuspid disease etiology – Primary – Secondary – Pacemaker induced – Other	68 (28.9) 61 (26.0) 14 (6.0) 92 (39.1)	198 (28.2) 392 (55.8) 40 (5.7) 73 (10.4)
Tricuspid regurgitation severity – Moderate – Severe	60 (25.3) 177 (74.7)	37 (4.9) 716 (95.1)
Tricuspid annular size (cm)	3.0 [2.8-3.3]	4.2 [2.0-4.5]
Mitral stenosis (any)	15 (10.0)	40 (7.2)
Mitral regurgitation – Moderate – Severe	27 (17.3) 9 (3.8)	179 (30.9) 43 (5.7)
Aortic stenosis (any)	13 (5.7)	92 (12.3)
Aortic insufficiency – Moderate – Severe	17 (7.3) 0 (0)	62 (8.3) 3 (0.4)
LVEF	58 [53-62]	55 [48-60]

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