Temporal Trends in Transcatheter Tricuspid Valve Interventions After FDA Approval in the United States

Abstract

Background

Transcatheter tricuspid valve interventions (TTVIs) have recently received commercial approval; however, contemporary adoption trends in early postapproval phase are not well described.

Objectives

The objectives of the study were to characterize trends in utilization of transcatheter tricuspid edge-to-edge repair (T-TEER) and transcatheter tricuspid valve replacement (TTVR) and to describe baseline patient characteristics and in-hospital outcomes.

Methods

We performed a retrospective cohort study using the Vizient Clinical Data Base including patients who underwent T-TEER or TTVR between October 2024 and December 2025. Monthly procedural trends, baseline characteristics, and in-hospital outcomes were evaluated.

Results

The study included 2,143 T-TEER procedures performed at 180 implanting hospitals; median annualized hospital volume 6.4 (IQR: 2.4-13.6) and 1,301 TTVR procedures performed at 113 implanting hospitals; median annualized hospital volume 6.4 (IQR: 3.2-11.2). Overall monthly volumes increased for both T-TEER (128 in October 2024 to 156 in December 2025; P for trend = 0.004) and TTVR (60 in October 2024 to 111 in December 2025; P for trend <0.001). The proportion of TTVR among all TTVI increased over time (from 31.9% to 41.6%; P for trend = 0.006). Baseline patient comorbidities of patients undergoing TTVI were similar to pivotal trial populations. In-hospital mortality was 0.5% following T-TEER and 2.0% following TTVR. The incidence of major bleeding was 6.0% and 12.4% after T-TEER and TTVR, respectively. Among TTVR patients, 11.3% required new pacemaker implantation.

Conclusions

There is increased adoption of both T-TEER and TTVR in early commercial experience with clinical characteristics of treated patients similar to those enrolled in pivotal trials. In-hospital outcomes were overall favorable supporting the generalizability of the pivotal trial findings to contemporary practice.

Central Illustration

Tricuspid regurgitation (TR) is associated with significant morbidity, including heart failure (HF) exacerbations and hospitalizations, as well as mortality.^1,2 Moderate to severe TR is present in up to 3% of the general population and its prevalence increases significantly with age approximating 9% in patients >75 years, making it the most common valvular heart disease in the elderly population.3, 4, 5 Despite medical therapy, which is limited to diuretic agents, patients often experience significant symptom burden and disease progression.^6,7 Isolated tricuspid valve surgery is associated with significant operative risk as patients are generally older with numerous comorbidities and are often referred late at advanced TR stages resulting in overall low penetrance of tricuspid valve surgery.^8,9

The emergence of transcatheter tricuspid valve interventions (TTVIs) has been promising in addressing this previously unmet need. Both tricuspid transcatheter edge-to-edge repair (T-TEER) and transcatheter tricuspid valve replacement (TTVR) were superior to medical therapy alone in the TRILUMINATE pivotal (Trial to Evaluate Cardiovascular Outcomes in Patients Treated with the Tricuspid Valve Repair System) and TRISCEND II pivotal trials (EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device), respectively, with benefits of device therapy being driven by improvements in patient-reported quality of life outcomes.^10,11 Two-year follow-up data from these 2 pivotal trials showed sustained improvements in quality of life outcomes and also suggested reduction in HF hospitalizations.^12,13 Other large randomized clinical trials and registry studies have demonstrated similar results.14, 15, 16, 17 In contemporary practice, heart teams are routinely tasked with selecting between TTVR and T-TEER based on patient comorbidities, bleeding risk, right ventricular function, and anatomical characteristics. Irrespective of treatment strategy, postprocedure multidisciplinary care involving valvular heart disease specialists, HF specialists, and cardiac rehabilitation is crucial to optimize long-term patient outcomes.

To our knowledge, temporal trends in the adoption of T-TEER and TTVR after their respective U.S. Food and Drug Administration (FDA) approvals in April 2024 and February 2024 have not been previously reported.^18,19 In addition, there is paucity of contemporary outcomes data for these therapies. In this study, we examine temporal trends in adoption of T-TEER and TTVR in the early postapproval phase, compare baseline demographic characteristics and comorbidity profiles between treatment groups, and report in-hospital clinical outcomes and resource utilization.

Methods

Data source

This retrospective cohort study used the Vizient Clinical Data Base (CDB), a comparative resource that contains line-item patient-level discharge data from over 97% of U.S. academic medical centers and >1,350 affiliated and community hospitals.²⁰ During the study period for this analysis, there were 1,328 continuously reporting hospitals in the CDB, of which there were 187 centers that performed TTVI. The CDB includes data on demographics, comorbidities, in-hospital outcomes, resource utilization, and costs to produce care for each hospital admission. The University of Vermont Medical Center Institutional Review Board approved this study with a waiver for individual informed consent. Data from the Vizient CDB used by permission of Vizient, Inc (all rights reserved).

Study population

All patients aged ≥40 years undergoing T-TEER or TTVR in the Vizient CDB were included. There were no predefined exclusion criteria. The International Classification of Diseases (ICD)-10th Revision diagnosis, and procedure codes used to define the study population are included in Supplemental Table 1.

Study outcomes

The primary objective of the study was to evaluate temporal trends in procedural volumes of T-TEER and TTVR from October 2024 to December 2025. We also assessed monthly trends in the number of hospitals performing T-TEER or TTVR. Our secondary objective was to examine baseline characteristics and in-hospital outcomes of patients undergoing T-TEER and TTVR in contemporary practice. Reported in-hospital outcomes included in-hospital mortality, major bleeding, new permanent pacemaker (PPM) placement, acute kidney injury (AKI), ischemic stroke, pericardial effusion/tamponade, hospital length of stay (LOS), and hospital costs. Costs were calculated by Vizient using cost-to-charge ratios to estimate cost to produce care. Total costs included direct and indirect costs; total direct costs were limited to those associated with direct patient care. The Vizient Vulnerability Index is a zip code-level measure of social vulnerability across 9 health-related domains, and uses geospatial modeling linked to life expectancy outcomes. Patients were categorized as low, average, or high vulnerability based on overall Vizient Vulnerability Index scores.²¹

Statistical analysis

Continuous variables are presented as median and IQR and were compared using the Wilcoxon rank sum test. Categorical variables are presented as frequencies and percentages and were compared using chi-square tests. No adjustment for multiple comparisons was performed, and the reported P values should be interpreted descriptively. Temporal trends of monthly procedural volumes for T-TEER and TTVR were assessed using the Mann-Kendall test to evaluate monotonic trends over time. Kendall τ was reported to measure strength and direction of the association between time (months) and procedure volume (absolute counts). Sen slope was calculated for T-TEER and TTVR, respectively, to evaluate median monthly change in procedural volume. The proportion of TTVR relative to total tricuspid procedures (T-TEER and TTVR) was evaluated using the Cochran-Armitage test for trend across monthly intervals. Annualized hospital procedural volumes were calculated by summing the total number of T-TEER or TTVR procedures performed at each hospital during the 15-month study period and dividing the cumulative volume by the total study duration to estimate an annualized procedural rate. The same study duration was used for all hospitals, regardless of when T-TEER or TTVR procedures were first performed. Hospitals were categorized according to annualized procedural volume using arbitrary cutoffs as low volume (≤5 cases/year), medium volume (6-10 cases/year), or high volume (>10 cases/year). We studied the absolute number of hospitals performing T-TEER and TTVR and examined monthly trends in number of hospitals performing any T-TEER or TTVR during a respective calendar month. Among hospitals performing both procedures, the correlation between annualized T-TEER and TTVR volumes was evaluated using Spearman rank correlation coefficient. Statistical significance was 2-sided, and a P value <0.05 was considered significant. All analyses were performed using SAS (version 9.4).

Results

Baseline characteristics

The study cohort comprised 2,143 patients who underwent T-TEER (median age 80.3 years; 58.8% female) and 1,301 who underwent TTVR (median age 79.4 years; 65.6% female) between October 2024 and December 2025. Approximately three-fourths of the patients in both groups were White and roughly 90% lived in zip codes categorized as low or average social vulnerability (Table 1).

Table 1.

Baseline Characteristics of Patients Undergoing Transcatheter Tricuspid Valve Interventions

	T-TEER (n = 2,143)	TTVR (n = 1,301)	P Value
Age (y), median (IQR)	80.3 (73.8-85.2)	79.4 (72.8-84.5)	0.033
Women, n (%)	1,259 (58.8%)	854 (65.6%)	<0.001
Race, n (%)			0.021
Asian	81 (3.8%)	65 (5.0%)
Black	233 (10.9%)	142 (10.9%)
White	1,641 (76.6%)	963 (74.0%)
Other	135 (6.3%)	110 (8.5%)
Unknown	53 (2.5%)	21 (1.6%)
Ethnicity, n (%)			0.538
Hispanic	133 (6.2%)	89 (6.8%)
Non-Hispanic	1,892 (88.3%)	1,132 (87.0%)
Unknown	118 (5.5%)	80 (6.2%)
Vizient Vulnerability Index, n (%)			0.042
Low vulnerability	589 (27.5%)	369 (28.4%)
Average vulnerability	1,333 (62.2%)	765 (58.8%)
High vulnerability	221 (10.3%)	167 (12.8%)
Comorbidities, n (%)
Hypertension	1,869 (87.2%)	1,190 (91.5%)	<0.001
Diabetes	652 (30.4%)	493 (37.9%)	<0.001
Prior PCI	311 (14.5%)	207 (15.9%)	0.266
Prior CABG	345 (16.1%)	209 (16.1%)	0.979
Prior MI	200 (9.3%)	135 (10.4%)	0.316
Heart failure	1,964 (91.7%)	1,235 (94.9%)	<0.001
CIED	595 (27.8%)	480 (36.9%)	<0.001
PAD	63 (2.9%)	40 (3.1%)	0.822
Smoking	861 (40.2%)	538 (41.4%)	0.496
Liver cirrhosis	230 (10.7%)	178 (13.7%)	0.010
COPD	271 (12.7%)	179 (13.8%)	0.348
Obesity	374 (17.5%)	266 (20.5%)	0.029
Chronic dialysis	121 (5.7%)	84 (6.5%)	0.330
Anemia	623 (29.1%)	529 (40.7%)	<0.001
Cerebrovascular disease	80 (3.7%)	60 (4.6%)	0.206
Atrial fibrillation	1,731 (80.8%)	1,128 (86.7%)	<0.001
Home oxygen	96 (4.5%)	56 (4.3%)	0.808
Prior stroke	375 (17.5%)	231 (17.8%)	0.848
Cancer	25 (1.2%)	12 (0.9%)	0.500
Coagulopathy	397 (18.5%)	492 (37.8%)	<0.001
Hospital characteristics, n (%)
Rural	6 (0.3%)	9 (0.7%)	0.075
Teaching hospital	1,430 (66.7%)	1,030 (79.2%)	<0.001
Region			0.184
Midwest	509 (23.8%)	321 (24.7%)
Northeast	448 (20.9%)	299 (23.0%)
South	658 (30.7%)	357 (27.4%)
West	528 (24.6%)	324 (24.9%)

Data from the Vizient Clinical Data Base used by permission of Vizient, Inc. All rights reserved.

No adjustment for multiple comparisons was performed, and the reported P values should be interpreted descriptively.

CABG = coronary artery bypass graft; CIED = cardiac implantable electronic device; COPD = chronic obstructive pulmonary disease; MI = myocardial infarction; PAD = peripheral artery disease; PCI = percutaneous coronary intervention; T-TEER = tricuspid transcatheter edge-to-edge repair; TTVR = transcatheter tricuspid valve replacement.

Atrial fibrillation was present in 80.8% and 86.7% of the T-TEER and TTVR recipients, respectively. Pre-existing cardiac implantable electronic devices (CIEDs) were more prevalent in TTVR than in the T-TEER group (36.9% vs 27.8%; P < 0.001). Coagulopathy (37.8% vs 18.5%; P < 0.001) and anemia (40.7% vs 29.1%; P < 0.001) were more prevalent among TTVR recipients. Prior percutaneous coronary intervention, prior coronary artery bypass grafting, prior myocardial infarction, chronic obstructive pulmonary disease, chronic dialysis, home oxygen use, and cancer had similar prevalence in both groups (Table 1). With respect to hospital setting, most procedures were performed at teaching hospitals (66.7% of T-TEER procedures vs 79.2% of TTVR procedures; P < 0.001). Most procedures were performed at urban hospitals with <1% of patients receiving T-TEER or TTVR at rural hospitals (Table 1).

Temporal trends

There was an increase in absolute volumes of both T-TEER and TTVR during the study period. T-TEER monthly volume increased from 128 procedures in October 2024 to 156 procedures in December 2025 (τ = 0.56; P for trend = 0.004) and TTVR volumes increased from 60 procedures in October 2024 to 111 procedures in December 2025 (τ = 0.75; P for trend <0.001) (Figure 1). The magnitude of increase was greater for TTVR, with a higher median monthly growth rate (Sen slope: +3.64 vs +2.77 cases/month, TTVR vs T-TEER, respectively). When assessed as relative utilization, the proportion of TTVR among all TTVI procedures increased from 31.9% in October 2024 to 41.6% in December 2025 (Z = 2.75; P = 0.006) (Figure 2).

Figure 1.

Trends in Tricuspid Transcatheter Edge-to-Edge Repair and Transcatheter Tricuspid Valve Replacement Absolute Monthly Procedural Volumes

Data from the Vizient Clinical Data Base used by permission of Vizient, Inc (all rights reserved). T-TEER = tricuspid transcatheter edge-to-edge repair; TTVR = transcatheter tricuspid valve replacement.

Figure 2.

Trends in Relative Utilization of Tricuspid Transcatheter Edge-to-Edge Repair and Transcatheter Tricuspid Valve Replacement

Data from the Vizient Clinical Data Base used by permission of Vizient, Inc (all rights reserved). Abbreviations as in Figure 1.

Hospital-level adoption trends

During the study period, 180 hospitals performed at least 1 T-TEER procedure and 113 performed at least 1 TTVR procedure. The number of implanting hospitals increased significantly over time for both T-TEER (Kendall’s τ = 0.65; P = 0.001) and TTVR (Kendall’s τ = 0.82; P < 0.001), consistent with progressive dissemination of both therapies (Figure 3). Among T-TEER performing hospitals, median (IQR) annualized hospital volume was 6.4 (2.4-13.6) with 46.5%, 20.8%, and 32.6% of hospitals being categorized as low (≤5 cases/year), medium (6-10 cases/year), or high volume (>10 cases/year), respectively. Among TTVR performing hospitals, median (IQR) annualized hospital volume was 6.4 (3.2-11.2) with 66.3%, 14.4%, and 19.2% of hospitals categorized as low, medium, or high volume, respectively. Among the 106 hospitals that performed both procedures, annualized T-TEER volume was not significantly correlated with annualized TTVR volume (Spearman ρ = 0.095; P = 0.330).

Figure 3.

Trends in Number of hospitals performing Tricuspid Transcatheter Edge-to-Edge Repair and Transcatheter Tricuspid Valve Replacement

Data from the Vizient Clinical Data Base used by permission of Vizient, Inc (all rights reserved). Abbreviations as in Figure 1.

In-hospital outcomes and resource utilization

In-hospital mortality was 0.5% in T-TEER cohort and 2.0% in TTVR cohort. In patients without CIED, rate of new pacemaker implantation was 11.3% after TTVR. Major bleeding occurred in 6.0% and 12.4% of T-TEER and TTVR groups, respectively. AKI occurred more frequently after TTVR than T-TEER (24.1% vs 13.1%, respectively). Ischemic stroke was observed in <1% of patients undergoing T-TEER and in none of the patients undergoing TTVR. Pericardial effusion/tamponade occurred in <1% of patients in both cohorts. The median hospital LOS was shorter in the T-TEER (1 [1-3] days) compared with TTVR recipients (4 [2-7] days). Both total ($70,700 vs $57,700) and direct ($50,000 vs $41,300) costs to produce care were higher in TTVR cohort compared with T-TEER (Table 2).

Table 2.

In-Hospital Outcomes of Patients Undergoing Transcatheter Tricuspid Valve Intervention

	T-TEER (n = 2,143)	TTVR (n = 1,301)	P Value
In-hospital mortality	10 (0.5%)	26 (2.0%)	<0.001
Pacemaker implantationa	12 (0.8%)	93 (11.3%)	<0.001
Acute kidney injury	281 (13.1%)	313 (24.1%)	<0.001
Major bleeding	129 (6.0%)	161 (12.4%)	<0.001
Ischemic stroke	<5 (<1.0%)	0 (0.0%)	NA
Pericardial effusion/tamponade	<5 (<1.0%)	<5 (<1.0%)	1.000
LOS (days), median (IQR)	1.0 (1.0-3.0)	4.0 (2.0-7.0)	<0.001
Total cost to produce care ($1,000s), median (IQR)	57.7 (44.1-74.9)	70.7 (53.7-89.0)	<0.001
Total direct cost to produce care ($1,000s), median (IQR)	41.3 (31.3-53.1)	50.0 (37.1-63.3)	<0.001

Data from the Vizient Clinical Data Base used by permission of Vizient, Inc (all rights reserved).

LOS = length of stay; other abbreviations as in Table 1.

^aIn patients without pre-existing CIED.

Discussion

This contemporary retrospective cohort study is the largest to date evaluating early postapproval adoption trends, baseline comorbidity profiles, and in-hospital outcomes of T-TEER and TTVR in the United States. The main findings of the study can be summarized as follows: 1) there has been an increase in absolute monthly procedural volumes of both T-TEER and TTVR; 2) the magnitude of increase in procedural volumes was greater for TTVR thereby resulting in a temporal increase in proportion of TTVR relative to all TTVI; 3) there were 180 hospitals that performed T-TEER and 113 that performed TTVR during the study period with median annualized volume of 6.4 cases per year for either procedure; 4) demographics and comorbidities of patients receiving TTVI in contemporary practice largely mirror those of the patients enrolled in pivotal trials; and 5) incidence of in-hospital safety events such as mortality, new PPM, and bleeding in contemporary practice was low in both T-TEER and TTVR cohorts with observed rates similar to those reported in pivotal randomized trials (Central Illustration).

Central Illustration.

Temporal Trends in Transcatheter Tricuspid Valve Interventions After Food and Drug Administration Approval in the United States

Data from the Vizient Clinical Data Base used by permission of Vizient, Inc (all rights reserved). FDA = Food and Drug Administration; PPM = permanent pacemaker; T-TEER = tricuspid transcatheter edge-to-edge repair; TTVI = transcatheter tricuspid valve interventions; TTVR = transcatheter tricuspid valve replacement.

To the best of our knowledge, this is the first study to report temporal trends in utilization of both T-TEER and TTVR since their respective FDA approvals. In addition to an increase in the absolute procedural volumes, we observed a progressive rise in the relative use of TTVR as a proportion of all TTVI, increasing from 31.9% in October 2024 to 41.6% in December 2025. These data are consistent with the fact that commercial rollout of T-TEER preceded that of Evoque TTVR in the United States with the implanting sites for the latter launched in a more staged fashion by the vendor following FDA approval. In the early commercial experience, concerns remained regarding whether the greater efficacy of TTVR in eliminating TR justified its higher procedural risk profile, including procedural mortality, major bleeding, PPM implantation, and potential for right ventricular failure due to greater afterload mismatch.²² In this context, the increasing relative use of TTVR may indicate greater acceptance of these trade-offs in selected patients, although this interpretation remains speculative and warrants further investigation.

There were 180 hospitals that performed any T-TEER procedure and 113 hospitals that performed any TTVR procedure during the study period. The median annualized case volume per site was relatively modest at 6.4 cases per year for either procedure. Importantly, only 32.6% and 19.2% of the hospitals performed more than 10 cases per year of T-TEER or TTVR, respectively, reflecting that most U.S. sites are still relatively early in their experience. In a recent Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry study by Makkar et al¹⁶ that reported early U.S. TTVR experience, there were 82 included Evoque implanting sites from February 2024 to March 2025. Our study included 113 Evoque implanting sites from October 2024 to December 2025, reflecting growing adoption of TTVI and also suggesting that the Vizient CDB captures most U.S. commercial TTVI procedures and implanting hospitals.

Compared with the TRILUMINATE and TRISCEND II trials, our cohort appears broadly similar in terms of demographics and baseline clinical profile.^10,11 Women comprised >50% of treated patients in our study, consistent with the predominance reported in both TRILUMINATE with ∼55% women and TRISCEND II with ∼75% women. Similarly, the burden of HF, atrial fibrillation, hypertension, diabetes, obesity, ischemic heart disease, and prior CIED in our T-TEER and TTVR cohorts was broadly consistent with the populations enrolled in the TRILUMINATE and TRISCEND II trials, respectively.^10,11 These findings suggest that patients undergoing TTVI in contemporary practice generally resemble the populations studied in the trials supporting approval of these therapies. Our data also capture patient groups who have been excluded from both TRILUMINATE and TRISCEND II. Approximately 6% of patients in both the T-TEER and TTVR cohorts of our study were on dialysis, a group excluded from both the TRILUMINATE and TRISCEND II trials. The STS/ACC TVT Registry study on postapproval Evoque experience showed worse clinical outcomes among patients on dialysis undergoing TTVR, with prevalence of chronic dialysis of approximately 6%, comparable to that observed in our cohort.¹⁶

Early outcomes for T-TEER and TTVR in our analysis were favorable and comparable with the TRILUMINATE and TRISCEND II trial data, respectively.^10,11 In-hospital mortality in our cohort was low, similar to that reported in TRILUMINATE for T-TEER (in-hospital mortality at 0% vs 0.5% in our cohort) and TRISCEND II for TTVR (30-day all-cause mortality at 3.5% vs 2% in-hospital mortality in our cohort). The observed in-hospital mortality for T-TEER in our Vizient cohort was 0.5%, which was lower than the 1.0% 30-day all-cause mortality reported in the multicenter bRIGHT study.¹⁴ In-hospital mortality in our TTVR cohort was slightly lower than that reported in the recent STS/ACC TVT Registry analysis (2.0% vs 2.3%, respectively).¹⁶ Similarly, in-hospital ischemic stroke occurred in <1% of patients in our T-TEER cohort, comparable to the 30-day stroke rate of 0% reported in TRILUMINATE.¹⁰ No in-hospital ischemic strokes were observed in the TTVR cohort. In-hospital major bleeding rates were higher in our analysis, occurring in 6.0% of T-TEER patients and 12.4% of TTVR patients, compared with the 30-day major bleeding rates reported in TRILUMINATE for T-TEER (4.7%) and TRISCEND II for TTVR (10.4%).^10,11 Bleeding rates in our T-TEER cohort were comparable to those reported in the multicenter bRIGHT study (30-day bleeding: 7.0%), whereas bleeding rates in our TTVR cohort were higher than those reported in the recent STS/ACC TVT Registry analysis (30-day bleeding: 7.9%).^14,16 These findings may reflect the high prevalence of coagulopathy, cirrhosis, and anemia in our cohort, as well as differences in bleeding definitions across studies. The higher rate of major bleeding observed in our TTVR cohort compared with the T-TEER cohort may be attributable to the greater burden of anemia and cirrhosis among patients undergoing TTVR. In contrast, the incidence of new pacemaker implantation in our TTVR cohort was lower than that reported in TRISCEND II (11.3% vs 24.7% at 30 days) and lower than the rate observed in the STS/ACC TVT Registry among CIED-naïve patients (12.3% in-hospital new CIED implantation).^11,16 Although patients undergoing TTVR are generally considered at high risk for new pacemaker implantation due to mechanical interaction between the prosthetic valve and the conduction system, our study demonstrated a comparatively lower incidence than previously reported.²³ The incidence of AKI was relatively high in both T-TEER and TTVR cohorts (13.1% and 24.1%, respectively). Potential contributors include intensive preprocedural diuresis used to optimize patients for intervention, as well as right ventricular afterload mismatch after reduction of TR with either therapy. The higher incidence after TTVR may reflect the greater afterload mismatch and associated decline in right ventricular function that can follow valve replacement.²⁴ Because these estimates were derived from ICD-coded data, they should be interpreted cautiously given the potential for misclassification. The median LOS in our T-TEER cohort was similar to that reported in TRILUMINATE, at 1 day.¹⁰ Similarly, the median LOS in our TTVR cohort was comparable to that reported for TTVR in the STS/ACC TVT Registry analysis, at 4 days.¹⁶ Longer LOS with TTVR than T-TEER is consistent with inherent differences between the postprocedural management pathways after the 2 procedures with need for longer inpatient monitoring for signs of right ventricular failure and conduction disturbances after TTVR. Direct and indirect costs were higher with TTVR compared with T-TEER, likely attributable to longer hospital LOS and also higher device costs.

Study Limitations

Our study has important limitations. The Vizient CDB lacks anatomical echocardiographic data important for treatment strategy selection such as jet location, coaptation gap, imaging quality, jet morphology, etc. Therefore, anatomical scoring systems such as the GLIDE score used for predicting T-TEER success, could not be calculated.²⁵ Similarly, data on right ventricular function, computed tomography–based annular measurements, cardiac magnetic resonance–derived metrics, and frailty that frequently inform the choice between T-TEER and TTVR were not available. The data set also lacks procedural measures of efficacy, including the degree of TR reduction, and does not capture device-specific complications such as embolization or malposition. Quality-of-life data were unavailable, precluding assessment of symptomatic benefit. Outcomes were limited to in-hospital events, differing from the 30-day outcomes reported in pivotal trials, and were ascertained using administrative ICD coding, rendering them susceptible to misclassification and coding variability. There were no data on long-term outcomes. Accordingly, these data cannot establish causal relationships, determine comparative effectiveness, or fully account for residual confounding. Annualized procedural volume calculations included all hospitals reporting data continuously during the study period, regardless of the timing of their first T-TEER or TTVR procedure, which may have resulted in underestimation of procedural volume at hospitals that initiated these procedures later in the study period. Lastly, although patients in our database are clustered within implanting hospitals, our analyses assume independent observations and do not account for within-hospital clustering. These limitations are inherent to retrospective analyses of administrative data sets and should be considered in interpreting the present findings.

Conclusions

In this contemporary analysis, the use of both T-TEER and TTVR increased following FDA approval, with a relatively greater increase observed for TTVR over time. There has been a parallel increase in number of sites performing TTVI with relatively modest annualized case volumes for either procedure. The clinical characteristics of treated patients and in-hospital outcomes were broadly similar to those reported in pivotal trials, suggesting alignment between trial populations and contemporary clinical practice.

Perspectives.

COMPETENCY IN MEDICAL KNOWLEDGE: The use of both T-TEER and TTVR has increased since FDA approval with a relatively greater rise in TTVR in contemporary clinical practice. There has been a parallel increase in number of sites performing transcatheter tricuspid interventions with relatively modest annualized case volumes for either procedure. The clinical characteristics of treated patients and in-hospital outcomes are largely comparable to those observed in pivotal trials.

TRANSLATIONAL OUTLOOK: With our study data demonstrating relatively modest annualized case volumes of TTVI, future studies will inform appropriate minimal volume benchmarks required to achieve competency in T-TEER and TTVR. Longer-term outcome data will inform heart-team decisions regarding choice of T-TEER vs TTVR in patients appropriate for either therapy.

Funding support and author disclosures

Dr Dauerman has received research support from Medtronic; and has served as a consultant for Medtronic and Laplace Interventional. Dr Gupta has consulted for Edwards Lifesciences and Medtronic. Dr Lahoud has served as a consultant for Medtronic. Dr Kolte has received research funding from the NIH/NHLBI, Medtronic, and Edwards Lifesciences outside of the submitted work; and serves on the CEC for Tioga Cardiovascular, Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.