From May 2020 to November 2023, a total of 188 patients were referred to the center for diagnosed TR. In China, this cardiac center was the first to introduce the totally thoracoscopic approach in the treatment of structural heart disease [19, 20]. Currently, the two most used techniques were TTC-TVS and transcatheter techniques based on TTVR for TR. The choice between TTVR and TTC-TVS was made by the multidisciplinary cardiac team, considering patient preferences, individual characteristics, and anatomical features of the right heart chambers and tricuspid valve (TV). Patients received guideline-directed medical therapy (GDMT) pre- and postoperatively to promote a successful recovery. All patients were deemed to be ineligible for conventional surgery and the inclusion criteria for the two groups in this study were as follows: (i) age > 18 years old; (ii) TR severity ≥ severe; (iii) New York Heart Association (NYHA) functional class ≥ II; (iv) failed GDMT; (v) Euro-SCORE > 4. The following were considered exclusion criteria: (i) left ventricular ejection fraction < 40%; (ii) systolic pulmonary arterial pressure > 60 mmHg; (iii) prior TV surgery or left-sided valve surgery within the past 6 months; (iv) irreversible poor right ventricular (RV) function; (v) concomitant significant lesion needed for other major cardiac procedures or infective endocarditis.

Promote early management of TR and advocate for the application of TTC-TVS in patients at high surgical risk (EuroSCORE II 4–8%). Additionally, the presence of carbon dioxide, patent foramen ovale, or atrial septal defects was not considered a contraindication for these beating-heart procedures. TTVR was primarily reserved for patients with prohibitive surgical risk (EuroSCORE II > 8%). Additional inclusion criteria included: (i) confirmation of TV morphologies through computed tomography scans, ensuring suitability for safe device implantation in the TV position; (ii) absence of jugular vein stenosis or irregular shape for the trans-jugular vein approach, and absence of severe thoracic deformities for the trans-right atrium approach.

In this retrospective study, all treatments administered to the patients strictly followed the ethical guidelines outlined in the Declaration of Helsinki, and participation in the study was voluntary with informed consent forms signed by all participants, indicating their thorough understanding of the study.

After identifying patients participating in this study, comprehensive baseline and perioperative data were collected. To ensure balanced follow-up between the two groups, patients underwent systematic assessments, including clinical evaluations, echocardiography, and laboratory testing at 3 months, 6 months, and 1-year postoperatively. One-year postoperatively, outpatient follow-ups were conducted every 6 months, and telephone follow-ups were done every 3 months to regularly monitor patient survival. Available last follow-up data was obtained before completion of the study. Patients’ survival status (dead or alive), reasons for unplanned hospitalizations (reoperation or compromised treatment), cause of death (cardiac or not), and the corresponding time were recorded. The follow-up period commenced at the surgical treatment of the patient and concluded either when the primary end point was achieved or when the study reached its conclusion.

The function of the TV and the severity of the TR can be demonstrated by quantifying the effective regurgitant orifice area and vena contracta width. This approach establishes a standardized method for measuring and determining the effectiveness of dedicated devices for TTVR and TTC-TVS in patients with TR. The severity of TR is categorized as none (0), mild (1+), moderate (2+), severe (3+), massive (4+), or torrential (5+) [21]. In addition, cardiac chamber dimensions and function were quantified following current recommendations; the corresponding parametric data were subsequently collected [22].

The features and technical characteristics of the LuX-Valve system (JensCare Biotech, Ningbo, Zhejiang, China) are described in Supplement Materials. The TTVR procedure utilizes the LuX-Valve system and was performed with the assistance of transesophageal echocardiography and fluoroscopic guidance. Patients undergoing the procedure were placed under general anesthesia. The bioprostheses of the LuX-Valve were released using a delivery system via the transjugular vein or right atrium approach, which was adjusted for optimal coaxiality and secured in place using septal anchoring and radial force-independent fixation (Fig. S1). Technical success was defined as placement of the device in the position of the TV and the removal of the delivery system without life-threatening adverse events during the implantation. Procedural success was defined as the successful implantation of the device, the patient being alive at the end of the procedure, and a postprocedural TR grade of < moderate (2+) [14, 16].

With the patient under general anesthesia, the TTC-TVS procedure involved tracheal intubation and establishing normothermic cardiopulmonary bypass via femoral–cervical vascular cannulation. Three 2-cm incisions at right thoracic were made to accommodate one thoracoscope and two operating handles as previously mentioned [19, 20]. The right atrium and pericardium were incised and stripped from the inferior vena cava, avoiding pericardial adhesion. Surgical characteristics were selected on the basis of operator judgment. However, a replacement operation was given priority if the patient has significant dilatation of the right-sided cardiac chambers or tricuspid annulus (Center Illustration A).

The TRI-SCORE was developed and validated to predict in-hospital mortality after ITVS and transcatheter intervention for TR [17, 18]. It was calculated according to the published scoring system, which considers factors such as age > 70 years, NYHA class III/IV, left ventricular ejection fraction, moderate/severe RV dysfunction (1 point each); right-sided heart failure signs, daily dose of furosemide > 125 mg, glomerular filtration rate, and elevated total bilirubin (2 points each). A risk score of ≤ 3 defined low risk, 4–5 defined intermediate risk, and 6 defined high risk.

The primary endpoint of this study was to assess the long-term outcomes of the two management strategies and determine the differences in (i) all-cause mortality; (ii) the combined of all-cause mortality with HHF. The secondary endpoint included the rates of HHF during the follow-up period, the assessment of improvements in NYHA functional class (defined as NYHA functional class improvement of at least 1 class at the last follow-up), TR severity [grade < moderate (2+) at the last follow-up echocardiographic scan]. The definition of HHF was new-onset or worsening signs and symptoms of heart failure that required urgent therapy resulting in hospitalization. To evaluate the last NYHA functional class value and the echocardiographic endpoints, patients were included in the analysis if they had survived for a minimum of 6 months following treatment for TR. The outcomes and complications were diagnosed and classified according to the updated Tricuspid Valve Academic Research Consortium document (T-VARC) [23].

Descriptive statistics were used to present the baseline characteristics of the study population. Continuous variables were expressed as the mean ± standard deviation or the median with quartile ranges. Results from categorical data were presented as n (%) for each category. Group comparisons were conducted using the Student t-test for normally distributed variables and the Mann–Whitney U test for non-normally distributed variables. The differences of categorical variables were assessed using the Pearson χ2 test.

Clinical risk factors associated with all-cause mortality and cardiac events were determined with univariate and multivariate analysis applying Cox proportional risk analysis. Hazard ratios (HR) and 95% confidence intervals (CI) were reported. Mortality rates (%) were calculated, and survival curves were constructed using Kaplan–Meier estimates. Group comparisons were performed using log-rank statistics. A P value < 0.05 was considered statistically significant. Statistical analyses were performed using R-Studio version 4.2.2 (R Foundation for Statistical Computing, Vienna, Austria).