Study population

This multicenter analysis included consecutive patients with severe TR referred to 6 tertiary care centers (5 in Poland and 1 in Italy) for screening and consideration for T‑TEER between January and December 2024. The study is part of the CAPTURE (Characterization of Patients and Treatment Outcomes in Severe Tricuspid Regurgitation) project (NCT06838611). For the present analysis, patient data were retrospectively retrieved from the participating centers’ databases and reviewed in accordance with the previously published study protocol.⁷

In all patients, transthoracic and transesophageal echocardiography (TEE) was performed by dedicated cardiologists with extensive experience in valvular heart disease imaging. The TV was assessed according to current guidelines using a 5‑grade TR severity scale based on quantitative characterization of TR.⁸ In the patients with CIEDs, the relationship between the TV‑crossing lead and TR was assessed echocardiographically by experienced imaging specialists at each participating center. CIED‑associated TR was diagnosed when no clear causative relationship between the lead presence and TR was identified. CIED‑related TR was defined as TR induced by direct lead interaction with the TV apparatus, such as leaflet impingement, adherence, or interference with leaflet motion.

Based on clinical and echocardiographic findings, the patients were evaluated by local heart teams and were either qualified for or disqualified from T‑TEER, according to established criteria.⁹ The primary reason for disqualification was recorded and categorized into the following groups: 1) asymptomatic TR; 2) clinical futility (eg, end‑stage heart failure, poor mobility, advanced frailty, or other conditions limiting expected survival); 3) unsuitable TV anatomy (eg, large coaptation gap, short or tethered leaflets, severe leaflet degeneration, significant lead interference); or 4) insufficient TEE visualization.

If, during the diagnostic process, additional cardiac conditions were identified in the referred patients with severe TR, the heart team could decide to qualify them for another type of intervention instead of T‑TEER. Following completion of that intervention, the indication for T‑TEER was reassessed, and qualification for the procedure was performed again according to the previously established criteria.

In addition to the abovementioned reasons for disqualification, for patients in whom the initial interventional treatment led to a reduction of TR severity below the severe threshold, a fifth category—TR grade reduction—was designated as the reason for disqualification.

Echocardiographic assessment and treatment qualification were performed locally at each participating center by experienced imaging specialists and multidisciplinary heart teams, without central adjudication or core laboratory analysis.

The protocol of the study was approved by the Ethics Committee of the Medical University of Warsaw (AKBE 179/2023) and endorsed by all participating centers. Data were retrieved from local institutional databases, and all participants provided written informed consent for data collection and analysis.

Statistical analysis

Statistical analysis was performed using the IBM SPSS Statistics software (version 29.0; IBM Corp., Armonk, New York, United States). Continuous data are presented as either mean and SD or median and interquartile range (IQR), and were compared with the t test or the Mann–Whitney test, depending on variable distribution. The assessment of the variable distribution was performed using the Shapiro–Wilk test. Categorical variables are presented as number and percentage, and were compared using the χ² test or Fisher exact test. Significance was established at a 2‑sided P value below 0.05.

Baseline characteristics

Patient characteristics according to CIED status are summarized in Table 1. Although the patients with CIEDs were of similar age to those without an implantable device (79 vs 76 y; P = 0.09), they presented with significantly more comorbidities. The prevalence of diabetes mellitus (35.4% vs 17.1%; P <⁠0.001) and chronic kidney disease (70.8% vs 54.4%; P = 0.006) was markedly higher among the individuals with CIEDs. They were also more likely to have a history of coronary artery bypass grafting (13.3% vs 4.4%; P = 0.009) and hospitalization for heart failure (78.8% vs 67.1%; P = 0.04).

Laboratory and imaging data further indicated decreased renal function and a more advanced associated organ dysfunction in the CIED group: higher median concentrations of urea (65.5 vs 55 mg/dl; P = 0.005), creatinine (1.4 vs 1.24 mg/dl; P = 0.02), and bilirubin (1 vs 0.84 mg/dl; P = 0.03), lower platelet count (171 vs 184 × 10³/µl; P = 0.046), and higher N‑terminal pro–B‑type natriuretic peptide levels (2033 vs 1573 pg/ml; P = 0.046). Echocardiography demonstrated lower left ventricular (LV) ejection fraction (50.5% vs 57%; P <⁠0.001), lower tricuspid annular plane systolic excursion (16.3 vs 18 mm; P = 0.007), larger LV end‑diastolic diameter (5.1 vs 4.9 cm; P = 0.003), and greater TR effective regurgitant orifice (0.7 vs 0.6 cm²; P = 0.01) in the patients with CIEDs, as compared with those without an implantable device.

Medication use also differed between the groups. The patients with CIEDs were more frequently treated with an angiotensin receptor‑neprilysin inhibitor (11.6% vs 1.3%; P <⁠0.001) and sodium‑glucose cotransporter 2 inhibitors (SGLT2is; 65.5% vs 41.8%; P <⁠0.001).

Qualification for transcatheter tricuspid edge‑to‑edge repair

Overall, 153 patients (56.5%) were qualified for T‑TEER. The qualification rate did not differ between the individuals with and without CIEDs (54% vs 58.3%; P = 0.49). Among the 113 disqualified patients, the most frequent reasons were unsuitable anatomy (31%), clinical futility (29.2%), and asymptomatic disease (23%), while insufficient TEE visualization (5.3%) and TR grade reduction (11.5%) were less common. The distribution of disqualification reasons was similar in the patients with and without CIEDs.

Cardiac implantable electronic device–related vs cardiac implantable electronic device–associated tricuspid regurgitation

Among the 113 patients with CIEDs, 37 (32.7%) were classified as having CIED‑related TR and 76 (67.3%) as having CIED‑associated TR. Compared with the individuals with CIED‑associated TR, those with CIED‑related TR more frequently presented with peripheral edema (81.1% vs. 60.5%; P = 0.03) and ascites (40.5% vs 15.8%; P = 0.004). Permanent atrial fibrillation was less common in the CIED‑related TR patients (54.1% vs 75%; P = 0.03), while the use of eplerenone (56.8% vs 36.8%; P = 0.045) and SGLT2is (81.1% vs 57.9%; P = 0.02) was more frequent in this group.

Echocardiographic evaluation showed that the patients with CIED‑related TR had a higher prevalence of torrential TR (59.5% vs 31.6%; P = 0.006) and a larger TR effective regurgitant orifice (0.9 vs 0.6 cm²; P = 0.02) than the individuals with CIED‑associated TR.

Transcatheter tricuspid edge‑to‑edge repair qualification according to type of cardiac implantable electronic device interaction

The rate of T‑TEER qualification did not differ between the patients with CIED‑related and CIED‑associated TR (59.5% vs 52.7%; P = 0.5). Similarly, the distribution of reasons for disqualification was comparable between the 2 subgroups, with anatomical factors representing the leading cause in both.

Limitations

This study has several limitations that should be acknowledged. First, its retrospective design carries a risk of selection bias and limits the ability to establish causal relationships. Second, echocardiographic assessment of TR severity, mechanism, and lead–valve interaction was not performed by an independent core laboratory but relied on evaluations by local imaging specialists and heart teams, which may have introduced intercenter variability in image interpretation and patient qualification. Third, decisions regarding T‑TEER qualification were made by local heart teams, potentially leading to differences in patient selection criteria across centers. Fourth, the primary aim of this study was not to assess procedural or clinical outcomes but to analyze the eligibility and qualification process for T‑TEER as determined by individual centers; therefore, no conclusions regarding treatment efficacy or long‑term outcomes can be drawn.

Finally, the absence of a significant difference in qualification rates between the groups should not be interpreted as evidence of equivalence. The study may have been underpowered to detect subtle differences, particularly in the CIED‑related TR subgroup. Furthermore, the observational design, lack of multivariable adjustment, and reliance on site‑reported echocardiographic assessment without core laboratory adjudication should be taken into account when interpreting these findings.

On the other hand, these features also reflect real‑world clinical practice, offering a representative overview of referral patterns and qualification processes for transcatheter TV interventions.

Conclusions

Patients with CIEDs referred to tertiary centers with severe TR represent a more complex and symptomatic population than the non‑CIED patients; however, the presence of a CIED does not appear to be independently associated with T‑TEER qualification in this real‑world cohort. These findings suggest that CIED presence alone should not preclude the referral of patients with severe TR for evaluation in specialized centers. Furthermore, the high prevalence of CIEDs and the considerable proportion of patients with lead‑related TR observed in this study underscore the relevance of this issue in contemporary practice. Our findings highlight the need for prospective, multicenter studies to validate these observations and to further refine the treatment qualification process in patients with severe TR and concomitant CIEDs.