Aim: The aim of this review is to evaluate procedural, clinical outcomes and safety profiles across major device platforms by synthesizing the available evidence on transcatheter tricuspid valve interventions. Design: Mixed methods systematic review of various studies evaluating Transcatheter tricuspid valve replacement Methods: The systematic review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and was prospectively registered in PROSPERO (CRD420251236274). Eligible studies included clinical trials, observational studies, and registry analyses evaluating transcatheter tricuspid valve interventions in adult patients. Risk of bias and methodological quality were assessed using the Cochrane RoB-2 tool for randomized trials, the ROBINS-I tool for non-randomized studies. Data extraction and quality assessment were performed independently by two reviewers, with discrepancies resolved by consensus or consultation with a third reviewer. Results: Nine studies randomized trials, prospective studies, and multicenter observational cohorts assessing transcatheter tricuspid valve interventions met the inclusion criteria. With notable improvements in NYHA functional class, KCCQ scores, and orthotopic transcatheter tricuspid valve replacement showed the most consistent procedural success and the greatest reduction in regurgitation severity. While heterotopic Caval valve implantation provided symptomatic relief without addressing underlying valvular pathology, leaflet repair techniques demonstrated more variable echocardiographic responses but produced significant symptomatic benefit. Conclusions: Transcatheter interventions for severe tricuspid and mitral regurgitation show promising clinical and functional benefits. Long-term data and randomized comparative evidence are still scarce despite promising early results, highlighting the need for additional prospective research to define optimal patient selection, device durability, and long-term clinical impact.
Transcatheter tricuspid valve replacement (TTVR) is a minimally invasive procedure that replaces the damaged tricuspid valve by a catheter which is inserted through a blood vessel. This is mostly recommended for individuals with tricuspid regurgitation (TR) and it involves a threading a catheter to the heart by position a new valve within the old valve [1]. TR is a clinical condition in which the tricuspid valve situated on the right side of the heart fails to close, appropriately. This alters the blood flow from the right ventricle to the right atrium of the heart during the contraction of myocardium. Mechanism of this condition can be multifaceted, more complex, and anatomically variable. Research analysis show that the TR effect is borderline in case of mortality, however it has a negative consequence on the quality of life and is an economically health care burden regarding the cost and resource utilization [2–4].
Diagnosed of TR can be performed through clinical examination, echocardiography (ECG), and imaging tests. Therapy is based on the lesions’ severity and diuretics to resist symptoms, surgical procedure to replace the tricuspid valve are treatment options [5]. This tricuspid valve surgery has an unpleasant choice for the patients as well as care providers due to the anatomical challenges. However, this choice of treatment is justified by comparing the deficiency of impact on the mortality of isolated tricuspid valve illnesses with the extreme fatality risk of cardiac surgery [6].
Invention, efficiency, and greater outcomes of transcatheter interventions for tricuspid valve diseases is an important subject with a promising impact on patient and health care [7]. Despite of overwhelming the evidence for the safety and effectiveness of the catheter-based approach to treat the TR, Food and Drug Administration (FDA) given approval for the TTVR (Edwards EVOQUE system) in 2024 [8]. Moreover, several trials are actively underway.
There are some challenges in TTVR which includes anatomically complex tricuspid annulus, complications with valve fixing, and interaction with pre-existing pacemaker leads which may lead to conduction problems. Apart from this, possible for acute increases in right ventricular afterload which may lead to heart failure, problems with accomplishing a complete seal to prevent paravalvular leakages, and uncertainty regarding durability, and valve thrombosis are some challenges in TTVR [9,10].
With an emphasis on orthotopic transcatheter valve replacement, leaflet-based repair systems, and heterotopic caval valve implantation, this systematic review investigates the available data on transcatheter therapies for severe tricuspid and mitral valve disease. In order to assess procedural strategies, device mechanisms, clinical effectiveness, safety outcomes, and echocardiographic impacts, the review includes clinical trials, feasibility studies, multicenter registries, and real-world datasets. Adults with clinically significant tricuspid or mitral regurgitation who are treated with catheter-based interventions because they are considered unsuitable for traditional surgery fall under this scope.
Increased mortality, progressive right-heart failure, and poor quality of life are all linked to severe tricuspid and mitral regurgitation. The standard of care is still surgery, but many patients are ineligible because of their advanced age, comorbidities, frailty, or excessive surgical risk. Despite the rapid emergence of new transcatheter valve technologies in recent years, the evidence is still dispersed across different device platforms, procedural approaches, and outcome reporting standards. No comprehensive review has evaluated trends in clinical response, procedural safety, and hemodynamic improvement across device classes or methodically compared results by device mechanism. In order to guide patient suitability, device selection, and future research priorities in this developing field, an integrated evaluation is therefore desperately needed. The objective of this review is to evaluate procedural features, clinical outcomes, echocardiographic changes, and safety profiles across major device platforms by methodically synthesizing the available evidence on transcatheter tricuspid and mitral valve interventions.
2.1 Eligibility Criteria This systematic review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines and was registered with PROSPERO (registration #(CRD420251236274)) 11]. Inclusion criteria included studies that evaluated the patients who underwent TAVI/TAVR, randomized clinical trial, observational studies and prospective feasible studies. Exclusion criteria were reviews, conference proceedings, dissertations, book chapters, letters to the editor, studies focusing solely on the development of TAVI devices, case report studies, studies without a clinical evaluation component, and studies without full-text availability 2.2 Information Sources The search strategy was included the covered literature published between January 2021 and November 2025. Databases searched included MEDLINE, Web of Science, Scopus, Google scholar, and Science Direct. This study includes both quantitative and qualitative data to provide important context-specific information on health care evaluation of both pre and post TAVI procedure. 2.3 Search Strategy Search terms and Medical Subject Headings (MeSH) focused on TAVI/TAVR and their evaluation in healthcare, emphasizing clinical outcomes as well as the patient care. It was refined the search, with limit results to English language studies published within the last five years. 2.4 Selection Process Microsoft Excel was utilized to organize the article selection process. Two independent reviewers examined titles, research types, and abstracts for relevance before conducting full-text reviews on possibly suitable papers. A third reviewer resolved the disagreements. Studies that met the inclusion criteria moved on to data extraction. 2.5 Data Collection Process The data was extracted using Microsoft Excel program. Two reviewers extracted data separately, while a third reviewer handled any differences. The data set includes study characteristics (country of study, design, population, sample size, and study purpose), intervention features (kind of device, process, and function), clinical parameters, and results. Difficult aspects and unfavorable situations associated with the intervention were reported. Missing or confusing data were rectified through reviewer consensus or by contacting the original paper. 2.6 Study Risk of Bias Assessment Non-randomized studies were assessed in the following areas using the Cochrane ROBINS-I instrument for risk of bias in nonrandomized studies: confounding, participant selection, intervention classification, deviations from intended interventions, missing data, outcome measurement, and choice of reported result. The ROBINS-I instrument offered four response possibilities for bias: low, moderate, severe, and critical (Sterne et al. 2019). We evaluated the quality of randomized controlled trials' study design and the degree of potential bias using the revised Cochrane RoB 2 instrument for risk of bias in randomized trials, taking into account the following domains: randomization, deviations from the intended intervention, missing data, outcome measurement, and selection of the reported result. The RoB 2 device offered three response options: low, considerable concerns, and high. 2.7 Synthesis Methods A narrative description was utilized to discuss the study designs, characteristics of participants, and outcome indicators. The outcomes of quantitative research were compared before and after the TAVI/TAVR intervention. We provided percentage and absolute changes for the experimental group. If any of the investigation's findings had similarities enough to merit comparison across two or more studies, our team combined the percentage change in outcome with a narrative synopsis. We intended to conduct a random-effects meta-analysis where a test of heterogeneity was substantial and there were three or more papers using similar techniques. We created a narrative summary of any qualitative findings. 2.8 Reporting Bias Assessment Potential reporting biases were assessed through a comparison of published outcomes against prespecified study protocols, where available, and evaluation of incomplete reporting within the studies. 2.9 Certainty Assessment The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach was used to assess the certainty of evidence across outcomes, incorporating the risk of bias, consistency and precision of effect estimates.
Figure.1 Prisma (2020) Flow Diagram
3.1 Study Selection
Electronic database searches yielded 1105 potentially relevant titles. After removing 71 duplicates and excluding 777 irrelevant articles based on the screening of titles and abstracts, 257 articles were considered for full- text review. Nine articles were included after excluding the articles based on the inclusion criteria. (Figure.1)
3.2 Study Designs and Populations
Table 1 summarizes the characteristics of the Nine studies included in this review. Publication years ranged from 2019 to 2025, with more publications in recent years. Among these, a plurality of studies was conducted in the USA [11–15]. The review comprised three randomized studies [12,16,17], and five non-randomized study studies including four prospective single-arm studies [11,13,14,18], and two retrospective studies [15,19]. These studies collectively assessed a range of novel valve replacement and leaflet- or annulus-modifying devices designed for high-risk patients with severe tricuspid regurgitation (TR) or mitral regurgitation (MR) who were unsuitable for conventional surgery.
The studies varied in methodological rigor, from highly controlled randomized trials—such as TRISCEND II and TRICAVAL—to large observational cohorts including the TriValve Registry and National Inpatient Sample analysis 18,20,21]. Across studies, populations consistently included older adults with advanced valvular disease, substantial comorbidities, and high surgical risk. Sample sizes ranged from small single-center feasibility cohorts to multi-center registries exceeding a thousand participants, offering a broad representation of contemporary patients undergoing transcatheter valve interventions.
3.3 Risk of Bias Analysis
The TRISCEND I trial and the Intrepid TMVR study demonstrated predominantly low-to-moderate risks across domains, reflecting strong methodological conduct and structured follow-up. Registry-based and feasibility studies showed greater variability 14,19,20], with serious concerns most commonly related to confounding and classification of interventions, which is expected in non-randomised device studies. Database analyses demonstrated serious risk particularly for confounding and classification bias due to inherent limitations in administrative coding datasets16]. (Figure.2)
TRISCEND II demonstrated low risk of bias across all assessed domains, including randomization, adherence to assigned intervention, outcome measurement, and reporting, resulting in an overall low risk classification 18]. Both TRICAVAL studies, and EuroIntervention (2020) and the TRICAVAL Pilot—showed predominantly low risk across outcome-related domains, but demonstrated some concerns in the domain relating to deviations from the intended intervention13,21]. Across all three studies, the lowest risk was observed in domains relating to missing outcome data, measurement methods, and selective reporting, reflecting standardized follow-up imaging and well-defined primary outcomes. (Figure.3)
Figure.2 ROBINS-I- Risk of Bias Analysis
Figure.3 Rob2- Risk of Bias analysis
3.4 Interventions and Device Mechanisms
All included studies evaluated catheter-based devices, but mechanisms varied substantially. Orthotopic tricuspid valve replacement systems—such as the EVOQUE, GATE, and LuX-Valve—aimed to eliminate TR by directly replacing the native tricuspid valve through transfemoral, trans-atrial, or transvenous approaches 15,18,19]. The EVOQUE platform dominated the prospective trials, highlighting the field’s shift toward percutaneous valve replacement as a definitive therapy 18]. In contrast, the TRICAVAL trial tested a heterotopic caval implantation strategy using the SAPIEN XT valve placed in the inferior vena cava, intended to reduce venous backflow rather than correct the valvular lesion itself 21]. Broader device heterogeneity was evident in the TriValve Registry, which included leaflet approximation (TEER), annuloplasty devices, and early replacement systems 12]. Mitral intervention was represented by the Intrepid TMVR system, a transapical orthotopic replacement device designed for patients with severe MR ineligible for edge-to-edge repair.
3.5 Procedural Approaches
Transfemoral delivery was the predominant access route across TR replacement trials due to its minimally invasive nature and suitability for severely ill patients. Trans-atrial or transapical access was employed in devices requiring more complex anchoring or larger delivery systems, such as the LuX-Valve and Intrepid TMVR. Across studies, procedures were universally guided by multimodality imaging—most commonly trans-esophageal echocardiography (TEE) and fluoroscopy—ensuring precise deployment and assessment of residual regurgitation. (Table.2)
3.6 Primary Objectives and Intended Outcomes
The overarching goals across studies were consistent: to reduce valve regurgitation, improve hemodynamic, alleviate symptoms, and provide therapeutic options for patients at prohibitive surgical risk. Randomized trials prioritized comparative effectiveness, such as EVOQUE TTVR vs. medical therapy (TRISCEND II) and CAVI vs. standard care (TRICAVAL), whereas registries and feasibility studies emphasized safety, device performance, and procedural success. Population-level analyses provided additional insight into real-world patterns, resource utilization, and comparative outcomes between transcatheter and surgical strategies.
3.7 Clinical outcomes
Transcatheter valve strategies for tricuspid and mitral disease consistently demonstrate clinically meaningful improvements in symptoms and functional status for appropriately selected, high-risk patients. In the pivotal TRISCEND II randomized program, transfemoral EVOQUE transcatheter tricuspid valve replacement (TTVR) produced superior hierarchical clinical outcomes driven largely by improvements in health-status measures (KCCQ), NYHA class, and 6-minute walk distance compared with medical therapy, while also impacting mortality- and hospitalization-related components of the composite endpoint 18]. Observational registry data and early feasibility cohorts corroborate these findings: the TriValve registry and single-arm TTVR series reported reduced heart-failure rehospitalization and improved survival or symptom scores in treated patients compared with historical or propensity-matched controls 20]. Even heterotopic strategies aimed at reducing systemic venous congestion—such as caval valve implantation (CAVI) studied in TRICAVAL—showed symptomatic relief from ascites and peripheral congestion despite not correcting the valve itself 21]. Finally, mitral replacement with the Intrepid system produced durable symptomatic and functional gains at 2-year follow-up in high-risk MR patients, indicating similar patient-level benefit when a durable valve solution is feasible 12]. (Table.3)
3.8 Procedural outcomes (technical success and safety)
Procedural success rates and safety profiles vary by device and generation, but common themes emerge: contemporary TTVR platforms achieve high rates of technical implantation success while incurring device-specific complications that must be weighed against clinical benefit. In TRISCEND II and earlier EVOQUE cohorts, implantation success was high and TR was markedly reduced in most patients, though the randomized program documented higher rates of major bleeding and new permanent pacemaker implantation in the TTVR arm—underscoring predictable device-related trade-offs 18]. Compassionate-use experience with GATE/NaviGate devices reported technical success in the majority of extremely high-risk patients, with some device mal-positioning and conversions to surgery illustrating the early-generation learning curve 14]. The LuX-Valve feasibility series similarly demonstrated high procedural success with attention to conduction-system safety via radial-force-independent anchoring 19]. In the smaller randomized TRICAVAL trial, CAVI implantation was feasible but demonstrated the need to monitor device-related complications and clinical equipoise in select subgroups 21]. The Intrepid TMVR program reported favorable procedural success in transapical deployment cohorts, with conversion/complication rates reflecting the complexity of mitral replacement in high-risk patients 12].
3.9 Echocardiographic and hemodynamic outcomes
Echocardiographic endpoints provide convergent evidence that orthotopic transcatheter replacement most reliably reduces regurgitant severity. Across TRISCEND cohorts, EVOQUE implantation reduced tricuspid regurgitation to ≤ mild in the large majority of implanted patients and produced measurable improvements in right-heart dimensions and forward flow parameters at follow-up 18]. Early-generation replacement devices (GATE, LuX, NaviGate variants) likewise reported substantial acute and midterm reductions in TR grade, albeit with isolated cases of paravalvular leak or right-heart failure that highlight the need for careful patient selection and imaging follow-up 14,19]. Heterotopic (CAVI) approaches do not alternative valvular regurgitation but produce hemodynamic relief of caval backflow and downstream organ congestion (TRICAVAL), while registry data show that device-specific repair techniques (TEER, annuloplasty) achieve more modest but clinically useful reductions in TR severity when anatomy permits 20]. In the mitral position, Intrepid TMVR reliably reduced MR severity to ≤ mild in the majority of treated high-risk patients, with associated improvements in stroke volume and symptomatic measures 12].
Table 1. Characteristics of the Studies Included in This Review
|
Study |
Year |
Country |
Study Design |
Sample Size |
Population |
Intervention |
Comparator |
Follow-up |
|
TRISCEND II |
2023 |
USA |
Randomized controlled trial |
— |
Severe TR, high surgical risk |
EVOQUE TTVR |
Medical therapy |
— |
|
TRISCEND I |
2021 |
USA |
Prospective single-arm |
— |
Severe TR |
EVOQUE TTVR |
None |
— |
|
TRICAVAL |
2018 |
Europe |
Randomized trial |
— |
Severe TR |
Caval Valve Implantation (CAVI) |
Medical therapy |
— |
|
TriValve Registry |
2020 |
Multinational |
Registry |
>1000 |
Severe TR |
TEER / Annuloplasty / TTVR |
None |
— |
|
Intrepid TMVR |
2021 |
USA |
Prospective study |
— |
Severe MR, high risk |
Intrepid TMVR |
None |
— |
|
GATE/NaviGate |
2019 |
USA |
Feasibility study |
— |
Severe TR |
Orthotopic TTVR |
None |
— |
|
LuX-Valve |
2022 |
China |
Prospective study |
— |
Severe TR |
LuX-Valve TTVR |
None |
— |
|
National Inpatient Sample |
2022 |
USA |
Retrospective database |
— |
TR patients |
Transcatheter therapy |
Surgery |
— |
Table 2. Types of Devices and Procedural Approaches
|
Device/System |
Valve Position |
Mechanism |
Access Route |
Imaging Guidance |
|
EVOQUE |
Tricuspid |
Orthotopic replacement |
Transfemoral |
TEE + Fluoroscopy |
|
GATE / NaviGate |
Tricuspid |
Orthotopic replacement |
Transatrial / Transvenous |
TEE + Fluoroscopy |
|
LuX-Valve |
Tricuspid |
Orthotopic replacement (radial-force independent anchoring) |
Transatrial |
TEE + Fluoroscopy |
|
SAPIEN XT (TRICAVAL) |
Caval (IVC) |
Heterotopic implantation |
Transfemoral |
TEE + Fluoroscopy |
|
TEER devices |
Tricuspid |
Leaflet approximation |
Transfemoral |
TEE |
|
Annuloplasty systems |
Tricuspid |
Annular reduction |
Transvenous |
TEE |
|
Intrepid TMVR |
Mitral |
Orthotopic replacement |
Transapical |
TEE + Fluoroscopy |
3.10 Resource utilization and health-system outcomes
Population-level analyses and registry follow-up provide perspective on health-system impact: national inpatient data indicate that transcatheter tricuspid procedures are increasingly utilized and can be associated with different patterns of length-of-stay, resource consumption, and in-hospital complication rates compared with surgical repair. Registry evidence suggests that successful TTVR may reduce heart-failure readmissions, a key driver of downstream cost and morbidity, whereas heterotopic strategies (CAVI) may primarily reduce symptom-driven admissions related to venous congestion rather than alter long-term valve-driven outcomes20,21]. Taken together, these data indicate that device choice and procedural success strongly modulate resource implications: devices that achieve durable reduction of regurgitation (orthotopic replacement, targeted repair in suitable anatomy) appear most likely to yield reductions in heart-failure utilization, while palliative strategies and early-generation systems may provide symptomatic benefit with variable effects on overall resource use.
Table 3. Comparative Clinical and Procedural Outcomes
|
Study/Device |
Technical Success |
TR/MR Reduction |
Symptom Improvement (NYHA/KCCQ) |
Major Complications |
Pacemaker Requirement |
|
TRISCEND II (EVOQUE) |
High |
TR ≤ mild in majority |
Significant improvement |
Major bleeding noted |
Increased vs medical therapy |
|
TRISCEND I |
High |
Marked TR reduction |
Improved functional status |
Acceptable safety profile |
Some cases |
|
TriValve Registry |
Variable |
Moderate–Severe TR reduction |
Improved symptoms |
Device-dependent |
Variable |
|
TRICAVAL |
Feasible |
No direct TR correction |
Relief of venous congestion |
Device-related issues |
Low |
|
GATE/NaviGate |
Moderate–High |
Significant TR reduction |
Improved symptoms |
Malposition in early cases |
Some |
|
LuX-Valve |
High |
Significant TR reduction |
Improved NYHA |
Low conduction risk |
Low |
|
Intrepid TMVR |
High |
MR ≤ mild in majority |
Sustained improvement at 2 years |
Procedure-related risks |
Variable |
4.1 Orthotopic TTVR as the dominant emerging strategy
Orthotopic replacement devices, particularly the EVOQUE system evaluated in the TRISCEND program, represent the strongest evidence base currently available 8,13]. These devices consistently achieved high implantation success rates, near-complete elimination of TR to mild or less in the vast majority of patients, and substantial improvements in health-related quality of life, including large gains in Kansas City Cardiomyopathy Questionnaire (KCCQ) scores 18]. Similar outcomes were observed despite the severely symptomatic, comorbidity-burdened nature of the enrolled populations. Early-generation devices such as GATE/NaviGate and the LuX-Valve also demonstrated the feasibility of complete TR elimination, although procedural risks including malposition, right-heart failure, and high sheath-size requirements were more common in these earlier experiences 12,19]. Importantly, reductions in TR were generally durable at mid-term follow-up (6–12 months), underscoring the potential of orthotopic TTVR as a therapeutic category that may fundamentally alter the management of severe TR.
4.2 Repair-based strategies remain valuable
Repair devices such as edge-to-edge repair (TEER) or direct annuloplasty systems contributed significantly to the evidence base through the TriValve registry 20]. While repair strategies typically produced meaningful but more modest reductions in TR severity compared with replacement, their lower procedural risk and the ability to treat anatomies unsuitable for replacement devices support their ongoing relevance in the therapeutic landscape. However, repair success remains highly dependent on leaflet quality, jet location, coaptation gaps, and annular dilation factors often unfavorable in advanced secondary TR. Registry evidence suggests repair devices improve symptoms and rehospitalization, but they rarely achieve complete TR elimination. As such, they may best serve patients with earlier-stage disease or anatomies not amenable to orthotopic replacement.
4.3 Heterotopic therapy provides palliative hemodynamic benefit
The TRICAVAL trial, which tested Caval valve implantation (CAVI), underscores the unique physiologic role of heterotopic devices 22]. By implanting valves in the inferior vena cava, CAVI reduces hepatic and systemic venous backflow but does not change native TR. Although the study showed symptomatic improvement and reduction in signs of venous congestion, the approach is clearly palliative and does not address the underlying valvular pathology. Thus, CAVI is most suitable for patients who are not candidates for orthotopic TTVR or repair due to anatomic constraints or advanced right-ventricular dysfunction.
4.4 Procedural and safety considerations across device classes
Across the included studies, procedural success and safety profiles varied largely by device type and access strategy. Transfemoral access, now standard for EVOQUE replacement, offers a favourable safety profile and shorter recovery compared with trans-atrial or transapical approaches required for early-generation devices 12,19]. Complication rates including bleeding, vascular complications, and new conduction disturbances were expectedly higher in early feasibility studies and decreased as device design and operator experience improved. Notably, the need for permanent pacemaker implantation emerged as an important safety signal with some replacement devices, reflecting anatomical proximity to the conduction system and the radial force of anchoring mechanisms 14]. These observations highlight the importance of device iteration and careful pre-procedural imaging to minimize complications.
4.5 Echocardiographic and hemodynamic improvements underscore mechanistic rationale
Echocardiographic outcomes across studies clearly favored orthotopic TTVR for achieving complete or near-complete TR reduction. Improved right-ventricular volumes, decreased vena contract width, and enhanced forward stroke volume were consistently observed after replacement, providing mechanistic support for clinical benefits 18]. In contrast, while repair devices achieved more modest reductions in TR, improvement in leaflet coaptation and annular geometry still translated into meaningful clinical benefit for selected patients 20]. Heterotopic devices improved venous hemodynamics but did not change TR severity, reinforcing their niche palliative role.
4.6 Clinical impact and patient-centered outcomes
Collectively, the included studies demonstrated substantial improvements in symptoms (NYHA class), functional capacity (6MWD), and quality of life (KCCQ), especially following orthotopic replacement 18]. These gains occurred early (within 30 days) and persisted through one year or longer in the trials that reported extended follow-up. The magnitude of symptomatic improvement in the TRISCEND cohorts was comparable to gains observed in landmark mitral and aortic transcatheter intervention trials, suggesting that TTVR may have similarly transformative potential when applied appropriately.
4.7 Health-system implications and real-world adoption
National Inpatient Sample (NIS) data indicated rapid adoption of transcatheter tricuspid interventions, with trends toward lower in-hospital mortality for TTVR compared with surgical tricuspid surgery in selected populations 14]. These findings align with the broader shift toward minimally invasive structural interventions and reinforce the need for continued expansion of dedicated tricuspid programs, enhanced operator training, and standardized reporting frameworks.
4.8 Knowledge gaps and future directions
Despite the promising evidence, several key uncertainties remain. First, long-term durability data for orthotopic TTVR are limited to 1–2 years, and the structural longevity of large tricuspid bio-prostheses remains unknown. Second, mortality benefit has not yet been conclusively demonstrated in randomized settings, in part because many studies are underpowered or use surrogate endpoints. Third, patient selection criteria require further refinement. Optimal candidates for replacement versus repair particularly in the setting of RV dysfunction—remain incompletely defined. Finally, the impact of TTVR on right-sided hemodynamics, renal/hepatic congestion, and long-term HF trajectory warrants expanded mechanistic study.
4.9 Strengths
This systematic review has several notable strengths. First, it provides a comprehensive and integrated synthesis of all major device categories currently shaping the landscape of transcatheter tricuspid and mitral valve interventions, including orthotopic replacement, leaflet-based repair, and heterotopic Caval implantation. This breadth allows for a nuanced understanding of how device mechanism, access strategy, and anatomical suitability influence procedural success and clinical outcomes. Second, the review incorporates evidence from multiple high-quality sources randomized controlled trials, prospective feasibility studies, multi-center registries, and population-level administrative datasets enabling triangulation of findings across different study designs and patient risk profiles. Third, the synthesis evaluates not only clinical endpoints but also echocardiographic, hemodynamic, and health-system outcomes, providing a holistic appraisal of therapeutic impact. Fourth, the review emphasizes device-specific procedural considerations and implementation challenges, which strengthens its clinical relevance for interventional cardiologists and structural heart teams. Finally, all findings were contextualized through rigorous cross-comparison, identifying consistent patterns across studies despite device heterogeneity and varying follow-up periods.
4.10 Limitations
Despite these strengths, several limitations must be acknowledged. The included evidence base is dominated by early-phase feasibility trials and single-arm observational studies, which inherently carry risks of selection bias, confounding, and limited external validity. Randomized controlled data remain sparse, particularly for long-term outcomes, limiting the ability to draw firm conclusions about mortality benefit and durability of prosthetic function. Follow-up durations in most studies were relatively short (typically 6–24 months), constraining assessment of structural valve deterioration and sustained right-heart remodeling. The heterogeneity of study populations, device types, imaging protocols, and endpoint definitions complicates direct comparison and pooled interpretation of results. Additionally, anatomical complexity and procedural learning curves varied across centers, potentially influencing outcomes reported in early-generation device studies. Administrative database analyses included in the review while valuable for understanding real-world trends are limited by coding accuracy, lack of granular clinical detail, and inability to capture echocardiographic or hemodynamic endpoints. Finally, publication bias remains possible, as device companies and early-adopting centers may be more likely to report favorable outcomes, while negative or aborted early experiences may be underrepresented.
This systematic review demonstrates that transcatheter treatments for tricuspid and mitral valve disease especially orthotopic TTVR are emerging as powerful therapies for symptomatic patients who previously had limited options. Orthotopic replacement delivers the most reliable TR elimination and the largest clinical and echocardiographic improvements, whereas repair and heterotopic approaches offer important alternatives for anatomically complex or advanced cases. Continued device evolution, high-quality randomized trials, and long-term follow-up are essential to define the full clinical impact and durability of these transformative therapies.