Percutaneous interventions for Tricuspid Regurgitation: A systematic review of early clinical trials

Percutaneous interventions for Tricuspid Regurgitation: A systematic review of early clinical trials | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Percutaneous interventions for Tricuspid Regurgitation: A systematic review of early clinical trials Nain Kamal Aulakh, Mira Srihastini Aridas, Aayush LNU, Manpal Kaur Sandhu, and 1 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7684936/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background Tricuspid Regurgitation is a prevalent and often undertreated valvular condition associated with poor prognosis when severe. Surgical intervention carries a high operative risk, especially in older patients or those with right ventricular dysfunction. In recent years, multiple percutaneous or transcatheter tricuspid valve interventions have emerged as alternatives, especially for patients who are considered unsuitable for surgery or at high surgical risk. Method This systemic review was conducted in accordance with PRISMA guidelines. A comprehensive search of PubMed, Cochrane Library, and ClinicalTrial.gov identified 74 articles, of which 9 early clinical trials were included. Data extraction and pooling was done, and analysis was performed based on functional outcomes like NYHA class, 6-minute walk distance along with quality of life, adverse events, and all-cause mortality. Results The procedural success rates across these early phase trials were consistently high (85% to 100%). Improvements in NYHA class were observed in 62% to 92% of patients, alongside meaningful gains in functional capacity and quality of life. Edge-to-edge repair devices demonstrated the most consistent functional benefit (91% NYHA improvement, mean + 85.5 m in 6MWA, + 17 KCCQ points), whereas valve replacement systems achieved reliable anatomical reduction with modest functional gains, and Mistral device showed marked improvements in a small feasibility cohort. The mortality rates were low but varied across the studies. Conclusion Early phase clinical trials demonstrated high procedural success rate, considerable improvement in functional status and quality of life. Larger randomized trials with extended follow-up are needed to confirm device durability and long-term clinical benefits. Tricuspid regurgitation Valve replacement Annuloplasty Edge-to-edge repair Figures Figure 1 Introduction Tricuspid valve regurgitation (TR) is a valvular disorder characterized by the retrograde flow of blood from the right ventricle into the right atrium during systole, resulting in elevated right atrial and central venous pressure [ 1 ]. TR may arise from primary causes, in which leaflets of the tricuspid valve is intrinsically abnormal due to congenital malformation, rheumatic heart disease, infective endocarditis or iatrogenic damage, and from secondary causes in which the anatomical structure of valvelets is not altered, but rendered incompetent due to right ventricular dilation, pulmonary hypertension, or left-sided heart disease [ 2 ]. Prevalence of trace to mild TR, though benign, is extremely common. According to the Framingham Heart Study, it was seen in around 82% of men and 85.7% of women [ 3 ]. Whereas the prevalence of moderate to severe TR is around 3–6% of the adult population in the US [ 1 ]. It is essential to detect and treat TR as it is associated with poor outcomes, including progressive right-sided heart failure, hepatic and renal dysfunction [ 4 ]. In patients with established heart failure, even incremental increase in TR severity worsen prognosis [ 5 ]. These data underscore the importance of timely recognition and management of TR. Conventional surgical repair or replacement, however, is often underutilized in advanced disease. Tricuspid surgery in patients with TR with right-sided heart failure has higher hospital mortality and has significantly high follow-up adverse events [ 6 ]. Also, comparing it with other single valve surgery, tricuspid valve replacement has 3–4 times higher rate of operative mortality along with other complications like bleeding, arrhythmias and prosthetic valve malfunction [ 7 ]. To address this concern, percutaneous interventions like Triclip, Pascal etc., are emerging as a promising new modality of treatment as they are versatile, preserve the native anatomy of valves and do not require strict anti-thrombotic therapy. For these reasons, they are associated with an improved patient’s functional status; shorter hospital stays with quicker recovery time and a better quality of life [ 8 , 9 ]. As the technology advanced, multiple device categories like Leaflet-based TEER systems (TriClip and PASCAL), valve replacement systems (EVOQUE and TricValve) and annuloplasty systems (Cardioband) are fast emerging. Despite the rapid advancement in percutaneous intervention, a major gap remains. Patients receiving late referral, short follow up with ignored long term complications and survival rates and heterogeneous selection with low sample size of participants are few of the limitations linked with the current trials. Moreover, the existing data is scattered across early phase trials and there is no single consolidated evidence based study which can satisfy all the shortcomings currently present in the trials. The primary aim of this study is to evaluate the feasibility, safety and early clinical outcomes of percutaneous tricuspid intervention by systematically reviewing and analyzing early clinical trials. Methods 2.1 Protocol and Registration This systematic review of early clinical trials evaluating percutaneous tricuspid valve interventions was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The protocol was prospectively registered with the International Prospective Register of Systematic Reviews (PROSPERO; registration number: CRD420251084853) [ 10 ]. 2.2 Eligibility Criteria (PICO Format) Population: Adult patients (≥ 18 years) with moderate-to-severe or severe TR, many of whom were considered inoperable or at high surgical risk due to advanced age, comorbidities, or underlying right heart dysfunction. Most patients were symptomatic, classified as New York Heart Association (NYHA) Class II–IV. Intervention: The intervention of interest comprised percutaneous transcatheter treatments for TR, including edge-to-edge repair (e.g., PASCAL Ace), annuloplasty devices (e.g., Cardioband), valve replacement systems (e.g., TricValve, EVOQUE, and LuX-Valve Plus), and other novel devices (e.g., Mistral system). Comparator: Most included studies were single-arm feasibility trials without a comparator or control arm; thus, no direct comparisons between transcatheter interventions and standard treatments were available. Outcomes: Primary outcomes included procedural success and TR severity reduction, while secondary outcomes assessed functional status (NYHA class), exercise capacity (6MWD), RV function (echo parameters), quality of life (KCCQ), adverse events, and all-cause mortality, with weighted averages used where applicable. 2.3 Search Strategy A systematic search was performed using electronic databases, including PubMed, Cochrane and ClinicalTrial.gov The search strategy combined Medical Subject Headings (MeSH) and free-text keywords. Key terms included “tricuspid regurgitation” OR “tricuspid insufficiency” AND (“transcatheter” OR “percutaneous” OR “transvenous”), designed to capture studies relevant to transcatheter tricuspid valve interventions. The search was limited to articles published between January 2020 and June 2025, to ensure inclusion of early clinical trials evaluating percutaneous therapies. 2.4 Study Selection Three reviewers independently screened all identified records by titles and abstracts. Full text articles were retrieved for studies deemed potentially eligible. Any conflicts or discrepancies were resolved either by fourth reviewer or through discussion among the team. Duplicate records were removed prior to screening. A total of 74 records were identified, of which 9 studies met the inclusion criteria for the final analysis. 2.5 Data Extraction Data from eligible studies were extracted into a standardized Excel spreadsheet. Extracted fields included the study title, author and year of publication, DOI, and study design. Patient characteristics were recorded, including the country of origin, sample size, population details, mean age, and severity of TR. Right ventricular (RV) function parameters, primarily based on echocardiographic findings, were also included. In addition, device type, procedural outcomes, and follow-up data were documented. Key outcome measures extracted included the proportion of patients achieving ≥ 1 grade TR reduction, percentage of patients with moderate-or-less TR at one-year follow-up, NYHA functional class improvement, mean change in 6-minute walk distance (6MWD), quality of life (QoL) assessments, adverse events, and all-cause mortality. 2.6 Risk of Bias Assessment Risk of bias was assessed at study level. Single arm feasibility and case series studies was assessed using the Joanna Briggs Institute (JBI) critical appraisal checklist for clinical trials, while non-randomized studies were evaluated using ROBINS-I tool. Risk of bias was evaluated at the study level across multiple domains: Two reviewers - independently assessed each study, and any discrepancies in judgment were resolved through discussion among the team or by a third reviewer. 2.7 Data Synthesis A pooled analysis was conducted for key clinical outcomes using weighted averages, including procedural success, mean change in 6-minute walk distance, QoL, and all-cause mortality. Subgroup analysis was performed based on device categories, including edge-to-edge repair, annuloplasty, valve replacement, and other novel devices. For outcomes that were not amenable to quantitative pooling, a descriptive synthesis was provided. Results 3.1 Study Selection Our search identified 76 articles from databases and two were removed as duplicates. Of these, 61 articles were excluded in initial title and abstract screening. Thirteen articles underwent full text review and four were excluded. Ultimately, nine articles were included in this systematic review. Figure 1 shows that The PRISMA flow diagram. 3.2 Study Characteristics Characteristics of included studies are summarized in Table 1 . All trials were early-phase, single arm studies with a relatively small sample size ranging between 7 to 65 patients. Randomization and blinding were not reported in any of the studies which is consistent with feasibility -stage interventions Table 1 Characteristics of included studies Study Device Type Sample Size Country Design Blasco-Turrión S et al 2024 TricValve system 44 Spain and Austria Prospective, nonblinded, nonrandomized, single-arm trial Davidson CJ, et al 2010 Cardioband tricuspid system 30 United States of America Single-arm, multicenter, prospective early feasibility study Nickenig G. et al 2021 Cardioband tricuspid system 30 European Union Single arm, multicentre, prospective study Planer D. et al 2020 Mistral device 7 Israel Clinical trial Webb J.G et al 2022 EVOQUE 27 United States of America Observational, non-randomised, single arm study Zhang Y et al 2023 LuX-Valve Plus (second-generation LuX-Valve) 10 China Clinical trial Kodali, S.K et al 2023 Edwards PASCAL TrAnScatheter Valve RePair System 65 United States of America Single-arm, multicenter, prospective Gray, W.A et al 2022 Cardioband Tricuspid Valve Reconstruction System 30 United States of America Multicenter, prospective, single-arm, early feasibility study Kodali, S et al 2023 PASCAL repair system 34 United States of America Single-arm, multicenter, prospective study 3.3 Risk of Bias Risk of bias assessments are presented in Table 2 . Using the JBI case series checklist and ROBINS-I tool where appropriate, most studies were judged at low-to-moderate risk of bias, reflecting limitations in study design, small sample sizes, and lack of comparators. Table 2 Risk of Bias assessment Study Risk of Bias Risk of Bias tool used Blasco-Turrión S et al 2024 Low-moderate JBI case series checklist Davidson CJ. et al 2010 Low-moderate JBI case series checklist Nickenig G. et al 2021 Low-moderate JBI case series checklist Planer D.et al 2020 Low-moderate JBI case series checklist Webb J.G et al 2022 Low-moderate JBI case series checklist Zhang Y.et al 2023 Low-moderate JBI case series checklist Kodali, S.K et al 2023 Moderate risk (non-randomised comparative) ROBINS-1 Gray, W.A et al 2022 Low-moderate JBI case series checklist Kodali, S.et al 2021 Low-moderate JBI case series checklist 3.4 Pooled Outcomes Across nine early phase clinical trials, 284 patients were enrolled (7 patients lost to follow-up); follow-up duration ranged from 30 days to 12 months. The key findings are summarized in Table 3 . Procedural success was consistently high across the studies, ranging from 85%-100%. Functional status improved in most patients, with 62% to 92% experiencing atleast one NYHA class improvement. Exercise capacity, as measured by the 6MWD, increased in all studies that reported it, with mean gains ranging from + 40 m to + 102 m. QoL improved consistently were reported, with increase of + 15 to + 20 points. Measures of TR reduction were consistently favorable, though reported in different formats (e.g., proportion achieving ≥ 1 grade reduction, or percentage with ≤ moderate TR). Where available, results showed a marked reduction in regurgitant severity. Adverse events varied by device type and reporting period. Major complications most commonly included bleeding, arrhythmias or conduction disturbances, and heart failure rehospitalization, with event ratws generally in the 10–25% range at early follow-up. Table 3 Summary of pooled outcomes 3.5 Subgroup Analysis Study Device Type Procedural Success NYHA Improvement 6-minute walk distance (mean change) Mortality Blasco-Turrión S et al 2024 TricValve system 95.5% 62.2% 40m 3 deaths at 1 year follow up Davidson CJ. et al 2010 Cardioband tricuspid system 93% 75% - 0 Nickenig G. et al 2021 Cardioband tricuspid system 100% 78% 42m 8 deaths at 2 years Planer D.et al 2020 Mistral device 100% No quantitative measurement 102m 0 Webb J.G et al 2022 EVOQUE 100% 70% 67m 2 deaths at 1 year Zhang Y.et al 2023 LuX-Valve Plus (second-generation LuX-Valve) 100% No quantitative measurement - 0 Kodali, S.K et al 2023 Edwards PASCAL TrAnScatheter Valve RePair System 88% 92% 94m 10.8% at 1 year Gray, W.A et al 2022 Cardioband Tricuspid Valve Reconstruction System 93.3% 80% 63m 6.7% at one 1 year Kodali, S.et al 2021 PASCAL repair system 85% 89% 71m 0 Table 4 Subgroup analysis by device type. Subgroup Analysis by device type Procedural success NHYA improvement 6-Minute Walk distance mean change QoL (KCCQ score improvement) Edge to Edge Repair 86.8% 91% 85.5m 17 points Annuloplasty Devices 95% 79% 52.5m 16.8 points Valve replacement device 97.5% 69.4% 53.5m Not reported Other/Novel device 100% No quantitative value 102m 20.2 points Subgroup analysis demonstrated variation in procedural and clinical outcomes as depicted in Table 4 . Novel devices, such as the mistral device, demonstrated a procedural success of 100%, however no quantitative values for NYHA class improvement were reported. Valve replacement devices were associated with the highest procedural success but a lower rate of NYHA functional improvement (69.4%) and gains in 6MWD were limited. Annuloplasty devices demonstrated a high procedural success rate of 95% but with a comparatively lower clinical benefit with only 79% of patients showing NYHA improvement and a smaller 6MWD increase. Edge to edge repair devices achieved a procedural success of 86.8% with the highest NYHA improvement (91%) and a substantial mean 6MWD improvement of 85.5m with a QoL improvement of 17 points. Limitations There are several limitations identified within this review. The majority of included trials were small, single-arm, and non-randomised, leading to potential selection and reporting biases. The follow-up durations were short, ranging from 30 days to 2 years, which limits assessment of long-term device durability, reintervention, and sustained clinical benefits. The heterogeneity in patient selection, TR etiology, and outcome definitions limited direct comparability across trials. Functional outcomes such as quality of life and 6-minute walking distance were inconsistently measured across the selected studies. Fourth, quality-of-life and mortality outcomes were inconsistently reported, with some studies omitting validated measures entirely. Finally, the lack of head-to-head randomised comparisons with surgery or medical therapy prevents definitive conclusions about relative efficacy. Discussion TR has long been considered the “forgotten valve” despite its association with right-sided heart failure, end-organ dysfunctional, and excess mortality [ 11 , 12 ]. Conventional surgical repair or replacement remains underutilized in advanced disease due to prohibitive perioperative risk and uncertain long term survival benefit [ 13 , 14 ]. Against this backdrop, the development of percutaneous interventions has generated growing enthusiasm, offering therapeutic options for patients previously deemed inoperable. The consistency of technical success and early clinical benefit observed across emerging platforms highlights the feasibility of this approach and underscores its potential to reshape the management of severe TR [ 15 – 23 ]. These findings are consistent with early registry data [ 24 ] and dedicated trials of edge-to-edge repair, such as TRILUMINATE study, which confirmed sustained symptomatic benefit and procedural safety [ 25 ]. Among available devices, edge-to-edge systems have shown the most consistent functional gains [ 15 , 16 ], annuloplasty devices demonstrated reliable anatomical remodelling but comparatively smaller clinical benefit [ 18 – 20 ], and valve replacement systems achieve near universal procedural success yet less pronounced improvement in symptoms, reflecting their use in patients with more advanced pathology [ 11 – 23 ]. Early experience with novel devices has also been encouraging, suggesting that innovative designs may expand treatment options in anatomically complex cases [ 17 ]. Importantly, compared with surgery, percutaneous interventions appear safer in high-risk populations [ 13 , 14 ], though long term durability and survival remain unproven. The clinical implications of these observations are significant. Device selection will likely depend on anatomical phenotype, with edge-to-edge repair suited to central regurgitant jets, annuloplasty for annular dilatation, and replacement for advanced disease [ 26 ]. Yet the evidence base remains limited by small sample size, short follow-up, and heterogeneity in outcome reporting. Moving forward, adequately powered randomized trials with standardized endpoints and extended follow-up are essential to establish durability, define survival benefit, and refine patient selection. Ultimately, the challenge lies not in demonstrating technical feasibility, which is now clear, but in proving that these interventions deliver sustained improvements in survival and QoL, sufficient to redefine the standard of care in tricuspid regurgitation. Conclusion Percutaneous tricuspid valve interventions have emerged as a promising option for patients deemed inoperable or at high surgical risk. Early phase trials consistently report high procedural success rates alongside improvements in functional status, exercise capacity, and QoL. Edge-to-edge devices such as PASCAL showed the most consistent gains in NYHA functional class, while newer systems like the Mistral device achieved substantial improvements in functional capacity. Annuloplasty and valve replacement platforms also demonstrated excellent intervention success, though functional outcomes varied, reflecting differences in anatomical complexity and patient selection. Although initial findings are promising, limitations such as small sample sizes, short follow-up durations and inconsistent outcome reporting underscores the urgent need for larger, randomized controlled trials with extended follow-up. Future research, including comparative analyses of device selection based on patient anatomy, should focus on assessing long-term device durability, survival benefits, rates of intervention, and impacts on heart failure hospitalizations. Abbreviations Tricuspid valve regurgitation (TR) Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Joanna Briggs Institute (JBI) Right ventricular (RV) 6-minute walk distance (6MWD) quality of life (QoL) New York Heart Association (NYHA) Declarations Ethics approval and consent to participate: ‘Not applicable’ Funding Declaration: ‘Not applicable’ Author Contribution Nain Kamal Aulakh: Conceived and designed the study, supervised the overall project, and critically revised the manuscript for important intellectual content.Mira Srihastini Aridas : Conducted the literature review, performed data analysis, and contributed substantially to drafting the results and discussion sections.Aayush: Assisted in study design, managed data collection and organization, and prepared the initial draft of the methods section.Manpal Kaur Sandhu: Contributed to statistical interpretation, prepared tables/figures, and revised the manuscript for technical accuracy.Srijamya: Coordinated the writing process, edited the introduction and conclusion, formatted the manuscript according to journal requirements, and ensured adherence to ethical and reporting guidelines. References Mulla S, Asuka E, Bora V, et al. Tricuspid Regurgitation. [Updated 2024 Oct 6]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK526121/ Ambrosino M, Sangoi M, Monzer N, et al. Tricuspid Regurgitation: A Review of Current Interventional Management. J Am Heart Assoc . 2024;13(6):e032999. doi:10.1161/JAHA.123.032999 Leurent G, Collet JP. The Tricuspid Valve: No Longer the Forgotten Valve!. JACC Cardiovasc Interv . 2019;12(24):2496-2498. doi:10.1016/j.jcin.2019.10.052 Leone PP, Chiarito M, Regazzoli D, et al. Prognostic value of tricuspid regurgitation. Rev Cardiovasc Med . 2022;23(2):76. doi:10.31083/j.rcm2302076 Seo J, Hong YJ, Batbayar U, et al. Prognostic value of functional tricuspid regurgitation quantified by cardiac magnetic resonance in heart failure. Eur Heart J Cardiovasc Imaging . 2023;24(6):742-750. doi:10.1093/ehjci/jeac224 von Ballmoos MCW, Reardon MJ. Surgical treatment of severe tricuspid regurgitation. Curr Opin Cardiol . 2021;36(5):538-541. doi:10.1097/HCO.0000000000000897 Mahboobi SK, Sharma S, Ahmed AA. Tricuspid Valve Repair. In: StatPearls . Treasure Island (FL): StatPearls Publishing; January 19, 2025. Mangieri A, Sticchi A, Gohar A, et al. Percutaneous Tricuspid Valve Repair. Rev Cardiovasc Med . 2022;23(7):220. Published 2022 Jun 24. doi:10.31083/j.rcm2307220 Nickenig G, Lurz P, Sorajja P, et al. Percutaneous Edge-to-Edge Repair for Tricuspid Regurgitation: 3-Year Outcomes From the TRILUMINATE Study. JACC Cardiovasc Interv . 2024;17(18):2113-2122. doi:10.1016/j.jcin.2024.05.036 Manpal Kaur Sandhu, Nain Kamal Aulakh, Mira Srihastini Aridas, Aayush Aayush, Srijamya Srijamya. Percutaneous Intervention for Tricuspid Regurgitation: A Systematic Review of Early Clinical Trials . PROSPERO 2025 CRD420251084853. Available from https://www.crd.york.ac.uk/PROSPERO/view/CRD420251084853. Reddy YNV, Alkhouli M, Nishimura RA. Isolated severe tricuspid regurgitation: an unrecognised and undertreated problem of the forgotten valve. Heart . 2021;107(5):350-352. doi:10.1136/heartjnl-2020-318399 Irwin RB, Luckie M, Khattar RS. Tricuspid regurgitation: contemporary management of a neglected valvular lesion. Postgrad Med J . 2010;86(1021):648-655. doi:10.1136/pgmj.2009.090886 Wang P, Huang Y, Sun L, Han Z. Surgical Treatment Strategy of Functional Tricuspid Regurgitation. Rev Cardiovasc Med . 2024;25(5):182. Published 2024 May 21. doi:10.31083/j.rcm2505182 Shimoda TM, Ueyama HA, Miyamoto Y, et al. Comparison of Transcatheter Versus Surgical Tricuspid Repair Among Patients With Tricuspid Regurgitation: Two-Year Results. Circ Cardiovasc Interv . 2025;18(1):e014825. doi:10.1161/CIRCINTERVENTIONS.124.014825 Kodali SK, Hahn RT, Davidson CJ, et al. 1-Year Outcomes of Transcatheter Tricuspid Valve Repair. J Am Coll Cardiol . 2023;81(18):1766-1776. doi:10.1016/j.jacc.2023.02.049 Kodali S, Hahn RT, Eleid MF, et al. Feasibility Study of the Transcatheter Valve Repair System for Severe Tricuspid Regurgitation. J Am Coll Cardiol . 2021;77(4):345-356. doi:10.1016/j.jacc.2020.11.047 Planer D, Beeri R, Danenberg HD. First-in-Human Transcatheter Tricuspid Valve Repair: 30-Day Follow-Up Experience With the Mistral Device. JACC Cardiovasc Interv . 2020;13(18):2091-2096. doi:10.1016/j.jcin.2020.05.050 Davidson CJ, Lim DS, Smith RL, et al. Early Feasibility Study of Cardioband Tricuspid System for Functional Tricuspid Regurgitation: 30-Day Outcomes. JACC Cardiovasc Interv . 2021;14(1):41-50. doi:10.1016/j.jcin.2020.10.017 Nickenig G, Weber M, Schüler R, et al. Tricuspid valve repair with the Cardioband system: two-year outcomes of the multicentre, prospective TRI-REPAIR study. EuroIntervention . 2021;16(15):e1264-e1271. Published 2021 Feb 5. doi:10.4244/EIJ-D-20-01107 Gray WA, Abramson SV, Lim S, et al. 1-Year Outcomes of Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study. JACC Cardiovasc Interv . 2022;15(19):1921-1932. doi:10.1016/j.jcin.2022.07.006 Blasco-Turrión S, Briedis K, Estévez-Loureiro R, et al. Bicaval TricValve Implantation in Patients With Severe Symptomatic Tricuspid Regurgitation: 1-Year Follow-Up Outcomes. JACC Cardiovasc Interv . 2024;17(1):60-72. doi:10.1016/j.jcin.2023.10.043 Webb JG, Chuang AM, Meier D, et al. Transcatheter Tricuspid Valve Replacement With the EVOQUE System: 1-Year Outcomes of a Multicenter, First-in-Human Experience. JACC Cardiovasc Interv . 2022;15(5):481-491. doi:10.1016/j.jcin.2022.01.280 Zhang Y, Lu F, Li W, et al. A first-in-human study of transjugular transcatheter tricuspid valve replacement with the LuX-Valve Plus system. EuroIntervention . 2023;18(13):e1088-e1089. Published 2023 Feb 6. doi:10.4244/EIJ-D-22-00517 Tabata N, Weber M, Tsujita K, Sinning JM, Nickenig G. Combined Percutaneous Therapy for Tricuspid Regurgitation Using the Cardioband and PASCAL System in 1 Procedure. JACC Cardiovasc Interv . 2019;12(22):e197-e198. doi:10.1016/j.jcin.2019.07.031 Nickenig G, Lurz P, Sorajja P, et al. Percutaneous Edge-to-Edge Repair for Tricuspid Regurgitation: 3-Year Outcomes From the TRILUMINATE Study. JACC Cardiovasc Interv . 2024;17(18):2113-2122. doi:10.1016/j.jcin.2024.05.036 Ponna PK, Patin S, Turaga NSS, et al. Transcatheter interventions for severe tricuspid regurgitation: a literature review. J Geriatr Cardiol . 2022;19(7):539-550. doi:10.11909/j.issn.1671-5411.2022.07.010 Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7684936","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":534280746,"identity":"a93dfb3b-36d3-4d03-a30c-2c27551221ab","order_by":0,"name":"Nain Kamal Aulakh","email":"","orcid":"","institution":"Sri Guru Ram Das Institute of Medical Sciences and Research Medical school","correspondingAuthor":false,"prefix":"","firstName":"Nain","middleName":"Kamal","lastName":"Aulakh","suffix":""},{"id":534280747,"identity":"44f7d24a-ec3b-45d3-914b-b88b913bee49","order_by":1,"name":"Mira Srihastini Aridas","email":"","orcid":"","institution":"Melbourne Medical School","correspondingAuthor":false,"prefix":"","firstName":"Mira","middleName":"Srihastini","lastName":"Aridas","suffix":""},{"id":534280748,"identity":"497c74cc-8369-40f0-9787-450fb223a9fe","order_by":2,"name":"Aayush LNU","email":"","orcid":"","institution":"NCR Institute of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Aayush","middleName":"","lastName":"LNU","suffix":""},{"id":534280749,"identity":"12b7db59-201b-4620-ac70-9f325d8ef327","order_by":3,"name":"Manpal Kaur Sandhu","email":"","orcid":"","institution":"Adesh Institute of medical sciences and research","correspondingAuthor":false,"prefix":"","firstName":"Manpal","middleName":"Kaur","lastName":"Sandhu","suffix":""},{"id":534280750,"identity":"f01d2028-5533-4341-b712-77f272d26042","order_by":4,"name":"Srijamya LNU","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA+UlEQVRIiWNgGAWjYFACxgYDGFPiA5BgYydFi+QMkBZmUiyU5gGRhLTIzz7cUPAz57A8g9jhg7dtfm2T52NmYPzwMQe3FoNziQ2GvdsOGzZIpyVb5/bdNmxjZmCWnLkNjxYeoF94tx1mbJDOMZPO7bnNCNTCxsyLR4t8D2OD4d9th+0bpPO/SVv23LYnqIXhDGODMdCWRKAtbNIMP24nEtRiANIiuy09uU06zdiyt+F2chszYzNev8j3sD8zfLvN2rZfOvnhjR9/btvOb28++OEjPocB4w4Ylc0MbCAmYxuYbMCrHgiYHzAw1EHZfwgpHgWjYBSMgpEIACO9TZqFlFCTAAAAAElFTkSuQmCC","orcid":"","institution":"Tbilisi State University","correspondingAuthor":true,"prefix":"","firstName":"Srijamya","middleName":"","lastName":"LNU","suffix":""}],"badges":[],"createdAt":"2025-09-23 00:23:39","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-7684936/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7684936/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":94622214,"identity":"8d16dc8c-b1c4-4f6e-a3f4-a20bbc6d0b8e","added_by":"auto","created_at":"2025-10-29 04:18:11","extension":"docx","order_by":0,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":67483,"visible":true,"origin":"","legend":"","description":"","filename":"PercutaneousinterventionsforTR1.docx","url":"https://assets-eu.researchsquare.com/files/rs-7684936/v1/dfbf2923c5e29194fe39ea95.docx"},{"id":94622653,"identity":"5abcb1f3-c797-4240-a76f-6e1d07d7cacf","added_by":"auto","created_at":"2025-10-29 04:18:26","extension":"json","order_by":1,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":7306,"visible":true,"origin":"","legend":"","description":"","filename":"52818425521243bc87c3479f94c676e7.json","url":"https://assets-eu.researchsquare.com/files/rs-7684936/v1/db4f3fa652abb058362a200d.json"},{"id":94622342,"identity":"6e57bb55-877b-4127-8072-b88c314be623","added_by":"auto","created_at":"2025-10-29 04:18:16","extension":"xml","order_by":2,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":82132,"visible":true,"origin":"","legend":"","description":"","filename":"52818425521243bc87c3479f94c676e71enriched.xml","url":"https://assets-eu.researchsquare.com/files/rs-7684936/v1/7e38fc3de0ce3495ececad84.xml"},{"id":94622147,"identity":"5cabf8f5-8ba3-4638-823d-e8e9816a5e55","added_by":"auto","created_at":"2025-10-29 04:17:58","extension":"eps","order_by":3,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":539,"visible":true,"origin":"","legend":"","description":"","filename":"drawingimage1.eps","url":"https://assets-eu.researchsquare.com/files/rs-7684936/v1/4482281f43dcf269d0900d43.eps"},{"id":94622337,"identity":"42a45e8c-b60e-4fd7-9cfe-24f6eea6534c","added_by":"auto","created_at":"2025-10-29 04:18:16","extension":"eps","order_by":4,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":549,"visible":true,"origin":"","legend":"","description":"","filename":"drawingimage2.eps","url":"https://assets-eu.researchsquare.com/files/rs-7684936/v1/aac2991cd14465eb17e94ce6.eps"},{"id":94622275,"identity":"69faa541-7745-4de1-b1bc-58fcda474203","added_by":"auto","created_at":"2025-10-29 04:18:15","extension":"eps","order_by":5,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":549,"visible":true,"origin":"","legend":"","description":"","filename":"drawingimage2.eps","url":"https://assets-eu.researchsquare.com/files/rs-7684936/v1/8be9fee84374731932da3420.eps"},{"id":94622862,"identity":"46494409-1565-4184-810b-8da19a857fc1","added_by":"auto","created_at":"2025-10-29 04:18:36","extension":"eps","order_by":6,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":549,"visible":true,"origin":"","legend":"","description":"","filename":"drawingimage2.eps","url":"https://assets-eu.researchsquare.com/files/rs-7684936/v1/f8726532269f37e82878a1b6.eps"},{"id":94622823,"identity":"413acfb3-d530-4de9-a4b2-c353ea0982f3","added_by":"auto","created_at":"2025-10-29 04:18:34","extension":"eps","order_by":7,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":522,"visible":true,"origin":"","legend":"","description":"","filename":"drawingimage5.eps","url":"https://assets-eu.researchsquare.com/files/rs-7684936/v1/e38ce2cb06bc4c5af39b2d6c.eps"},{"id":94622277,"identity":"0b2ebc84-b021-445b-8c3f-e77b62f4c089","added_by":"auto","created_at":"2025-10-29 04:18:15","extension":"eps","order_by":8,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":65190,"visible":true,"origin":"","legend":"","description":"","filename":"drawingimage6.eps","url":"https://assets-eu.researchsquare.com/files/rs-7684936/v1/6b7ad6aeee50f406aff17a9a.eps"},{"id":94622692,"identity":"74dde887-36e7-49dd-a491-88660770b5a7","added_by":"auto","created_at":"2025-10-29 04:18:28","extension":"jpeg","order_by":9,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":77856,"visible":true,"origin":"","legend":"","description":"","filename":"floatimage1.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-7684936/v1/341debfee8030aad5e526660.jpeg"},{"id":94622672,"identity":"fed3ee9d-5c09-4932-8eb8-2bdb508ce1a3","added_by":"auto","created_at":"2025-10-29 04:18:27","extension":"jpeg","order_by":10,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":272867,"visible":true,"origin":"","legend":"","description":"","filename":"floatimage2.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-7684936/v1/ad4fc25c15bd6b012737dabe.jpeg"},{"id":94622834,"identity":"1ca23560-b403-4131-80c9-1ae8b5006576","added_by":"auto","created_at":"2025-10-29 04:18:34","extension":"jpeg","order_by":11,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":34448,"visible":true,"origin":"","legend":"","description":"","filename":"floatimage3.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-7684936/v1/9bb93a054ab7435b6d57252b.jpeg"},{"id":94622198,"identity":"ff6c3ca5-ce63-49d1-836a-e4c925c2e34e","added_by":"auto","created_at":"2025-10-29 04:18:10","extension":"jpeg","order_by":12,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":301709,"visible":true,"origin":"","legend":"","description":"","filename":"floatimage4.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-7684936/v1/dcc51f3f94c7320a9623fc27.jpeg"},{"id":94622431,"identity":"95c2e372-53ad-400d-bd93-119142c2f66e","added_by":"auto","created_at":"2025-10-29 04:18:19","extension":"jpeg","order_by":13,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":27704,"visible":true,"origin":"","legend":"","description":"","filename":"floatimage5.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-7684936/v1/f54e22ede2854b8a842e62ce.jpeg"},{"id":94622893,"identity":"f626789e-9e54-4b59-9b9e-fb0c9db85794","added_by":"auto","created_at":"2025-10-29 04:18:38","extension":"jpeg","order_by":14,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":25874,"visible":true,"origin":"","legend":"","description":"","filename":"floatimage6.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-7684936/v1/b9188068d7d3b501f08e3383.jpeg"},{"id":94622657,"identity":"75c8b45b-eb46-4555-a64a-929274886ad8","added_by":"auto","created_at":"2025-10-29 04:18:26","extension":"jpeg","order_by":15,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":1074,"visible":true,"origin":"","legend":"","description":"","filename":"floatimage7.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-7684936/v1/14e29eb540e5769a86ff940b.jpeg"},{"id":94622258,"identity":"1942d486-ed2b-44a8-86fc-34c30b5b8d20","added_by":"auto","created_at":"2025-10-29 04:18:14","extension":"png","order_by":16,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":14184,"visible":true,"origin":"","legend":"","description":"","filename":"Onlinefloatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-7684936/v1/2d4832054f8ab9a6187ce8a9.png"},{"id":94622836,"identity":"1ecd2478-a0f7-4b77-8db7-e769092b7858","added_by":"auto","created_at":"2025-10-29 04:18:34","extension":"png","order_by":17,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":60230,"visible":true,"origin":"","legend":"","description":"","filename":"Onlinefloatimage2.png","url":"https://assets-eu.researchsquare.com/files/rs-7684936/v1/e3a863b0028e76975bd63fa7.png"},{"id":94622433,"identity":"70d742c5-a94d-48cf-9472-c3bc05b7301c","added_by":"auto","created_at":"2025-10-29 04:18:19","extension":"png","order_by":18,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":6617,"visible":true,"origin":"","legend":"","description":"","filename":"Onlinefloatimage3.png","url":"https://assets-eu.researchsquare.com/files/rs-7684936/v1/42a8e48ae8ab97660ff02910.png"},{"id":94622153,"identity":"2a31d1bf-2e2f-4254-a794-53600c2ddd77","added_by":"auto","created_at":"2025-10-29 04:18:01","extension":"png","order_by":19,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":60306,"visible":true,"origin":"","legend":"","description":"","filename":"Onlinefloatimage4.png","url":"https://assets-eu.researchsquare.com/files/rs-7684936/v1/98760733b5833e8d58010d3e.png"},{"id":94622268,"identity":"68d9f2a2-f68c-4a6b-888e-db5729edcae4","added_by":"auto","created_at":"2025-10-29 04:18:14","extension":"png","order_by":20,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":5905,"visible":true,"origin":"","legend":"","description":"","filename":"Onlinefloatimage5.png","url":"https://assets-eu.researchsquare.com/files/rs-7684936/v1/dcf0309679506cbaa5677034.png"},{"id":94622279,"identity":"e0603a92-7244-4ac3-b656-9603e79c75f7","added_by":"auto","created_at":"2025-10-29 04:18:15","extension":"png","order_by":21,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":5018,"visible":true,"origin":"","legend":"","description":"","filename":"Onlinefloatimage6.png","url":"https://assets-eu.researchsquare.com/files/rs-7684936/v1/9ff147d66a1100926685075c.png"},{"id":94622636,"identity":"90690e57-a4e1-4966-81b3-54885f5950bc","added_by":"auto","created_at":"2025-10-29 04:18:26","extension":"png","order_by":22,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":935,"visible":true,"origin":"","legend":"","description":"","filename":"Onlinefloatimage7.png","url":"https://assets-eu.researchsquare.com/files/rs-7684936/v1/0d5d5c822b951b666ac0d5d7.png"},{"id":94622145,"identity":"f415f662-ed85-4975-9bf5-4e3580dbe572","added_by":"auto","created_at":"2025-10-29 04:17:57","extension":"xml","order_by":23,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":80117,"visible":true,"origin":"","legend":"","description":"","filename":"52818425521243bc87c3479f94c676e71structuring.xml","url":"https://assets-eu.researchsquare.com/files/rs-7684936/v1/088014502bc8b93f3c99770e.xml"},{"id":94622436,"identity":"2499f07d-5ca0-484c-83e5-0a8d1062e08e","added_by":"auto","created_at":"2025-10-29 04:18:19","extension":"html","order_by":24,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":90440,"visible":true,"origin":"","legend":"","description":"","filename":"earlyproof.html","url":"https://assets-eu.researchsquare.com/files/rs-7684936/v1/f25de8b3b48b03db0b5993a7.html"},{"id":94622377,"identity":"b006adf0-8ac6-42dc-a31a-c0f38076a6f3","added_by":"auto","created_at":"2025-10-29 04:18:18","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":72288,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003ePRISMA study selection flowchart\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-7684936/v1/f978607fee802a3520d6bdcf.png"},{"id":105804775,"identity":"c31e2f11-6443-4b76-ab7c-66da89fbd525","added_by":"auto","created_at":"2026-03-31 10:12:35","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":814761,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7684936/v1/ea2197c2-8092-4ade-820f-e2d71ef7dde0.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Percutaneous interventions for Tricuspid Regurgitation: A systematic review of early clinical trials","fulltext":[{"header":"Introduction","content":"\u003cp\u003eTricuspid valve regurgitation (TR) is a valvular disorder characterized by the retrograde flow of blood from the right ventricle into the right atrium during systole, resulting in elevated right atrial and central venous pressure [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. TR may arise from primary causes, in which leaflets of the tricuspid valve is intrinsically abnormal due to congenital malformation, rheumatic heart disease, infective endocarditis or iatrogenic damage, and from secondary causes in which the anatomical structure of valvelets is not altered, but rendered incompetent due to right ventricular dilation, pulmonary hypertension, or left-sided heart disease [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e].\u003c/p\u003e\u003cp\u003ePrevalence of trace to mild TR, though benign, is extremely common. According to the Framingham Heart Study, it was seen in around 82% of men and 85.7% of women [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. Whereas the prevalence of moderate to severe TR is around 3\u0026ndash;6% of the adult population in the US [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. It is essential to detect and treat TR as it is associated with poor outcomes, including progressive right-sided heart failure, hepatic and renal dysfunction [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. In patients with established heart failure, even incremental increase in TR severity worsen prognosis [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. These data underscore the importance of timely recognition and management of TR.\u003c/p\u003e\u003cp\u003eConventional surgical repair or replacement, however, is often underutilized in advanced disease. Tricuspid surgery in patients with TR with right-sided heart failure has higher hospital mortality and has significantly high follow-up adverse events [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Also, comparing it with other single valve surgery, tricuspid valve replacement has 3\u0026ndash;4 times higher rate of operative mortality along with other complications like bleeding, arrhythmias and prosthetic valve malfunction [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. To address this concern, percutaneous interventions like Triclip, Pascal etc., are emerging as a promising new modality of treatment as they are versatile, preserve the native anatomy of valves and do not require strict anti-thrombotic therapy. For these reasons, they are associated with an improved patient\u0026rsquo;s functional status; shorter hospital stays with quicker recovery time and a better quality of life [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eAs the technology advanced, multiple device categories like Leaflet-based TEER systems (TriClip and PASCAL), valve replacement systems (EVOQUE and TricValve) and annuloplasty systems (Cardioband) are fast emerging. Despite the rapid advancement in percutaneous intervention, a major gap remains. Patients receiving late referral, short follow up with ignored long term complications and survival rates and heterogeneous selection with low sample size of participants are few of the limitations linked with the current trials. Moreover, the existing data is scattered across early phase trials and there is no single consolidated evidence based study which can satisfy all the shortcomings currently present in the trials. The primary aim of this study is to evaluate the feasibility, safety and early clinical outcomes of percutaneous tricuspid intervention by systematically reviewing and analyzing early clinical trials.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003ch2\u003e2.1 Protocol and Registration\u003c/h2\u003e\u003cp\u003e This systematic review of early clinical trials evaluating percutaneous tricuspid valve interventions was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The protocol was prospectively registered with the International Prospective Register of Systematic Reviews (PROSPERO; registration number: CRD420251084853) [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e].\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec4\" class=\"Section2\"\u003e\u003ch2\u003e2.2 Eligibility Criteria (PICO Format)\u003c/h2\u003e\u003cp\u003ePopulation: Adult patients (\u0026ge;\u0026thinsp;18 years) with moderate-to-severe or severe TR, many of whom were considered inoperable or at high surgical risk due to advanced age, comorbidities, or underlying right heart dysfunction. Most patients were symptomatic, classified as New York Heart Association (NYHA) Class II\u0026ndash;IV.\u003c/p\u003e\u003cp\u003eIntervention: The intervention of interest comprised percutaneous transcatheter treatments for TR, including edge-to-edge repair (e.g., PASCAL Ace), annuloplasty devices (e.g., Cardioband), valve replacement systems (e.g., TricValve, EVOQUE, and LuX-Valve Plus), and other novel devices (e.g., Mistral system).\u003c/p\u003e\u003cp\u003eComparator: Most included studies were single-arm feasibility trials without a comparator or control arm; thus, no direct comparisons between transcatheter interventions and standard treatments were available.\u003c/p\u003e\u003cp\u003eOutcomes: Primary outcomes included procedural success and TR severity reduction, while secondary outcomes assessed functional status (NYHA class), exercise capacity (6MWD), RV function (echo parameters), quality of life (KCCQ), adverse events, and all-cause mortality, with weighted averages used where applicable.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec5\" class=\"Section2\"\u003e\u003ch2\u003e2.3 Search Strategy\u003c/h2\u003e\u003cp\u003eA systematic search was performed using electronic databases, including PubMed, Cochrane and ClinicalTrial.gov The search strategy combined Medical Subject Headings (MeSH) and free-text keywords. Key terms included \u0026ldquo;tricuspid regurgitation\u0026rdquo; OR \u0026ldquo;tricuspid insufficiency\u0026rdquo; AND (\u0026ldquo;transcatheter\u0026rdquo; OR \u0026ldquo;percutaneous\u0026rdquo; OR \u0026ldquo;transvenous\u0026rdquo;), designed to capture studies relevant to transcatheter tricuspid valve interventions. The search was limited to articles published between January 2020 and June 2025, to ensure inclusion of early clinical trials evaluating percutaneous therapies.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec6\" class=\"Section2\"\u003e\u003ch2\u003e2.4 Study Selection\u003c/h2\u003e\u003cp\u003eThree reviewers independently screened all identified records by titles and abstracts. Full text articles were retrieved for studies deemed potentially eligible. Any conflicts or discrepancies were resolved either by fourth reviewer or through discussion among the team. Duplicate records were removed prior to screening. A total of 74 records were identified, of which 9 studies met the inclusion criteria for the final analysis.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec7\" class=\"Section2\"\u003e\u003ch2\u003e2.5 Data Extraction\u003c/h2\u003e\u003cp\u003eData from eligible studies were extracted into a standardized Excel spreadsheet. Extracted fields included the study title, author and year of publication, DOI, and study design. Patient characteristics were recorded, including the country of origin, sample size, population details, mean age, and severity of TR. Right ventricular (RV) function parameters, primarily based on echocardiographic findings, were also included. In addition, device type, procedural outcomes, and follow-up data were documented. Key outcome measures extracted included the proportion of patients achieving\u0026thinsp;\u0026ge;\u0026thinsp;1 grade TR reduction, percentage of patients with moderate-or-less TR at one-year follow-up, NYHA functional class improvement, mean change in 6-minute walk distance (6MWD), quality of life (QoL) assessments, adverse events, and all-cause mortality.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\u003ch2\u003e2.6 Risk of Bias Assessment\u003c/h2\u003e\u003cp\u003eRisk of bias was assessed at study level. Single arm feasibility and case series studies was assessed using the Joanna Briggs Institute (JBI) critical appraisal checklist for clinical trials, while non-randomized studies were evaluated using ROBINS-I tool. Risk of bias was evaluated at the study level across multiple domains: Two reviewers - independently assessed each study, and any discrepancies in judgment were resolved through discussion among the team or by a third reviewer.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec9\" class=\"Section2\"\u003e\u003ch2\u003e2.7 Data Synthesis\u003c/h2\u003e\u003cp\u003eA pooled analysis was conducted for key clinical outcomes using weighted averages, including procedural success, mean change in 6-minute walk distance, QoL, and all-cause mortality. Subgroup analysis was performed based on device categories, including edge-to-edge repair, annuloplasty, valve replacement, and other novel devices. For outcomes that were not amenable to quantitative pooling, a descriptive synthesis was provided.\u003c/p\u003e\u003c/div\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\u003ch2\u003e3.1 Study Selection\u003c/h2\u003e\u003cp\u003eOur search identified 76 articles from databases and two were removed as duplicates. Of these, 61 articles were excluded in initial title and abstract screening. Thirteen articles underwent full text review and four were excluded. Ultimately, nine articles were included in this systematic review. Figure\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e shows that The PRISMA flow diagram.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e\u003ch2\u003e3.2 Study Characteristics\u003c/h2\u003e\u003cp\u003eCharacteristics of included studies are summarized in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. All trials were early-phase, single arm studies with a relatively small sample size ranging between 7 to 65 patients. Randomization and blinding were not reported in any of the studies which is consistent with feasibility -stage interventions\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eCharacteristics of included studies\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"5\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eStudy\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eDevice Type\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eSample Size\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eCountry\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eDesign\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBlasco-Turri\u0026oacute;n S et al 2024\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eTricValve system\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e44\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eSpain and Austria\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eProspective, nonblinded, \u003c/p\u003e\u003cp\u003enonrandomized, single-arm trial\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDavidson CJ, et al 2010\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eCardioband tricuspid system\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e30\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eUnited States of America\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eSingle-arm, multicenter, prospective early feasibility study\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNickenig G. et al 2021\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eCardioband tricuspid system\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e30\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eEuropean Union\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eSingle arm, multicentre, prospective study\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePlaner D. et al 2020\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eMistral device\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e7\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eIsrael\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eClinical trial\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eWebb J.G et al 2022\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eEVOQUE\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e27\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eUnited States of America\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eObservational, non-randomised, single arm study\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eZhang Y et al 2023\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eLuX-Valve Plus (second-generation LuX-Valve)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e10\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eChina\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eClinical trial\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eKodali, S.K et al 2023\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eEdwards PASCAL TrAnScatheter Valve RePair System\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e65\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eUnited States of America\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eSingle-arm, multicenter, prospective\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eGray, W.A et al 2022\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eCardioband Tricuspid Valve Reconstruction System\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e30\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eUnited States of America\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eMulticenter, prospective, single-arm, early feasibility study\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eKodali, S et al 2023\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003ePASCAL repair system\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e34\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eUnited States of America\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eSingle-arm, multicenter, prospective study\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec13\" class=\"Section2\"\u003e\u003ch2\u003e3.3 Risk of Bias\u003c/h2\u003e\u003cp\u003eRisk of bias assessments are presented in Table \u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e. Using the JBI case series checklist and ROBINS-I tool where appropriate, most studies were judged at low-to-moderate risk of bias, reflecting limitations in study design, small sample sizes, and lack of comparators.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eRisk of Bias assessment\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"3\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eStudy\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eRisk of Bias\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eRisk of Bias tool used\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBlasco-Turri\u0026oacute;n S et al 2024\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eLow-moderate\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eJBI case series checklist\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDavidson CJ. et al 2010\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eLow-moderate\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eJBI case series checklist\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNickenig G. et al 2021\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eLow-moderate\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eJBI case series checklist\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePlaner D.et al 2020\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eLow-moderate\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eJBI case series checklist\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eWebb J.G et al 2022\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eLow-moderate\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eJBI case series checklist\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eZhang Y.et al 2023\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eLow-moderate\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eJBI case series checklist\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eKodali, S.K et al 2023\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eModerate risk (non-randomised comparative)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eROBINS-1\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eGray, W.A et al 2022\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eLow-moderate\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eJBI case series checklist\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eKodali, S.et al 2021\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eLow-moderate\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eJBI case series checklist\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec14\" class=\"Section2\"\u003e\u003ch2\u003e3.4 Pooled Outcomes\u003c/h2\u003e\u003cp\u003eAcross nine early phase clinical trials, 284 patients were enrolled (7 patients lost to follow-up); follow-up duration ranged from 30 days to 12 months. The key findings are summarized in Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e. Procedural success was consistently high across the studies, ranging from 85%-100%. Functional status improved in most patients, with 62% to 92% experiencing atleast one NYHA class improvement. Exercise capacity, as measured by the 6MWD, increased in all studies that reported it, with mean gains ranging from +\u0026thinsp;40 m to +\u0026thinsp;102 m. QoL improved consistently were reported, with increase of +\u0026thinsp;15 to +\u0026thinsp;20 points.\u003c/p\u003e\u003cp\u003eMeasures of TR reduction were consistently favorable, though reported in different formats (e.g., proportion achieving\u0026thinsp;\u0026ge;\u0026thinsp;1 grade reduction, or percentage with \u0026le;\u0026thinsp;moderate TR). Where available, results showed a marked reduction in regurgitant severity. Adverse events varied by device type and reporting period. Major complications most commonly included bleeding, arrhythmias or conduction disturbances, and heart failure rehospitalization, with event ratws generally in the 10\u0026ndash;25% range at early follow-up.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eSummary of pooled outcomes 3.5 Subgroup Analysis\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"6\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eStudy\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eDevice Type\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eProcedural Success\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eNYHA Improvement\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003e6-minute walk distance (mean change)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c6\"\u003e\u003cp\u003eMortality\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBlasco-Turri\u0026oacute;n S et al 2024\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eTricValve system\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e95.5%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e62.2%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e40m\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e3 deaths at 1 year follow up\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDavidson CJ. et al 2010\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eCardioband tricuspid system\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e93%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e75%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNickenig G. et al 2021\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eCardioband tricuspid system\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e100%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e78%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e42m\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e8 deaths at 2 years\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePlaner D.et al 2020\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eMistral device\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e100%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eNo quantitative measurement\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e102m\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eWebb J.G et al 2022\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eEVOQUE\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e100%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e70%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e67m\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e2 deaths at 1 year\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eZhang Y.et al 2023\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eLuX-Valve Plus (second-generation LuX-Valve)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e100%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eNo quantitative measurement\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eKodali, S.K et al 2023\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eEdwards PASCAL TrAnScatheter Valve RePair System\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e88%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e92%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e94m\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e10.8% at 1 year\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eGray, W.A et al 2022\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eCardioband Tricuspid Valve Reconstruction System\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e93.3%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e80%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e63m\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e6.7% at one 1 year\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eKodali, S.et al 2021\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003ePASCAL repair system\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e85%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e89%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e71m\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eSubgroup analysis by device type.\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"5\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSubgroup Analysis by device type\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eProcedural success\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eNHYA improvement\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003e6-Minute Walk distance mean change\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eQoL (KCCQ score improvement)\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eEdge to Edge Repair\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e86.8%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e91%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e85.5m\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e17 points\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAnnuloplasty Devices\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e95%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e79%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e52.5m\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e16.8 points\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eValve replacement device\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e97.5%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e69.4%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e53.5m\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eNot reported\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eOther/Novel device\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e100%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eNo quantitative value\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e102m\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e20.2 points\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eSubgroup analysis demonstrated variation in procedural and clinical outcomes as depicted in Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e. Novel devices, such as the mistral device, demonstrated a procedural success of 100%, however no quantitative values for NYHA class improvement were reported.\u003c/p\u003e\u003cp\u003eValve replacement devices were associated with the highest procedural success but a lower rate of NYHA functional improvement (69.4%) and gains in 6MWD were limited. Annuloplasty devices demonstrated a high procedural success rate of 95% but with a comparatively lower clinical benefit with only 79% of patients showing NYHA improvement and a smaller 6MWD increase. Edge to edge repair devices achieved a procedural success of 86.8% with the highest NYHA improvement (91%) and a substantial mean 6MWD improvement of 85.5m with a QoL improvement of 17 points.\u003c/p\u003e\u003c/div\u003e"},{"header":"Limitations","content":"\u003cp\u003eThere are several limitations identified within this review. The majority of included trials were small, single-arm, and non-randomised, leading to potential selection and reporting biases. The follow-up durations were short, ranging from 30 days to 2 years, which limits assessment of long-term device durability, reintervention, and sustained clinical benefits. The heterogeneity in patient selection, TR etiology, and outcome definitions limited direct comparability across trials. Functional outcomes such as quality of life and 6-minute walking distance were inconsistently measured across the selected studies. Fourth, quality-of-life and mortality outcomes were inconsistently reported, with some studies omitting validated measures entirely. Finally, the lack of head-to-head randomised comparisons with surgery or medical therapy prevents definitive conclusions about relative efficacy.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eTR has long been considered the \u0026ldquo;forgotten valve\u0026rdquo; despite its association with right-sided heart failure, end-organ dysfunctional, and excess mortality [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. Conventional surgical repair or replacement remains underutilized in advanced disease due to prohibitive perioperative risk and uncertain long term survival benefit [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. Against this backdrop, the development of percutaneous interventions has generated growing enthusiasm, offering therapeutic options for patients previously deemed inoperable. The consistency of technical success and early clinical benefit observed across emerging platforms highlights the feasibility of this approach and underscores its potential to reshape the management of severe TR [\u003cspan additionalcitationids=\"CR16 CR17 CR18 CR19 CR20 CR21 CR22\" citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eThese findings are consistent with early registry data [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e] and dedicated trials of edge-to-edge repair, such as TRILUMINATE study, which confirmed sustained symptomatic benefit and procedural safety [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. Among available devices, edge-to-edge systems have shown the most consistent functional gains [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e], annuloplasty devices demonstrated reliable anatomical remodelling but comparatively smaller clinical benefit [\u003cspan additionalcitationids=\"CR19\" citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e], and valve replacement systems achieve near universal procedural success yet less pronounced improvement in symptoms, reflecting their use in patients with more advanced pathology [\u003cspan additionalcitationids=\"CR12 CR13 CR14 CR15 CR16 CR17 CR18 CR19 CR20 CR21 CR22\" citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. Early experience with novel devices has also been encouraging, suggesting that innovative designs may expand treatment options in anatomically complex cases [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. Importantly, compared with surgery, percutaneous interventions appear safer in high-risk populations [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e], though long term durability and survival remain unproven.\u003c/p\u003e\u003cp\u003eThe clinical implications of these observations are significant. Device selection will likely depend on anatomical phenotype, with edge-to-edge repair suited to central regurgitant jets, annuloplasty for annular dilatation, and replacement for advanced disease [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e]. Yet the evidence base remains limited by small sample size, short follow-up, and heterogeneity in outcome reporting. Moving forward, adequately powered randomized trials with standardized endpoints and extended follow-up are essential to establish durability, define survival benefit, and refine patient selection. Ultimately, the challenge lies not in demonstrating technical feasibility, which is now clear, but in proving that these interventions deliver sustained improvements in survival and QoL, sufficient to redefine the standard of care in tricuspid regurgitation.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003ePercutaneous tricuspid valve interventions have emerged as a promising option for patients deemed inoperable or at high surgical risk. Early phase trials consistently report high procedural success rates alongside improvements in functional status, exercise capacity, and QoL. Edge-to-edge devices such as PASCAL showed the most consistent gains in NYHA functional class, while newer systems like the Mistral device achieved substantial improvements in functional capacity. Annuloplasty and valve replacement platforms also demonstrated excellent intervention success, though functional outcomes varied, reflecting differences in anatomical complexity and patient selection.\u003c/p\u003e\u003cp\u003eAlthough initial findings are promising, limitations such as small sample sizes, short follow-up durations and inconsistent outcome reporting underscores the urgent need for larger, randomized controlled trials with extended follow-up. Future research, including comparative analyses of device selection based on patient anatomy, should focus on assessing long-term device durability, survival benefits, rates of intervention, and impacts on heart failure hospitalizations.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cul\u003e\n \u003cli\u003eTricuspid valve regurgitation (TR)\u003c/li\u003e\n \u003cli\u003ePreferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)\u003c/li\u003e\n \u003cli\u003eJoanna Briggs Institute (JBI)\u003c/li\u003e\n \u003cli\u003eRight ventricular (RV)\u003c/li\u003e\n \u003cli\u003e6-minute walk distance (6MWD)\u003c/li\u003e\n \u003cli\u003equality of life (QoL)\u003c/li\u003e\n \u003cli\u003eNew York Heart Association (NYHA)\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"Declarations","content":"\u003ch2\u003eEthics approval and consent to participate:\u003c/h2\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026lsquo;Not applicable\u0026rsquo;\u003c/strong\u003e\u003c/p\u003e\n\u003ch2\u003eFunding Declaration:\u0026nbsp;\u003c/h2\u003e\n\u003cp\u003e\u0026lsquo;Not applicable\u0026rsquo;\u003c/p\u003e\n\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\n\u003cp\u003eNain Kamal Aulakh: Conceived and designed the study, supervised the overall project, and critically revised the manuscript for important intellectual content.Mira Srihastini Aridas : Conducted the literature review, performed data analysis, and contributed substantially to drafting the results and discussion sections.Aayush: Assisted in study design, managed data collection and organization, and prepared the initial draft of the methods section.Manpal Kaur Sandhu: Contributed to statistical interpretation, prepared tables/figures, and revised the manuscript for technical accuracy.Srijamya: Coordinated the writing process, edited the introduction and conclusion, formatted the manuscript according to journal requirements, and ensured adherence to ethical and reporting guidelines.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eMulla S, Asuka E, Bora V, et al. Tricuspid Regurgitation. [Updated 2024 Oct 6]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK526121/\u003c/li\u003e\n\u003cli\u003eAmbrosino M, Sangoi M, Monzer N, et al. Tricuspid Regurgitation: A Review of Current Interventional Management. \u003cem\u003eJ Am Heart Assoc\u003c/em\u003e. 2024;13(6):e032999. doi:10.1161/JAHA.123.032999\u003c/li\u003e\n\u003cli\u003eLeurent G, Collet JP. The Tricuspid Valve: No Longer the Forgotten Valve!. \u003cem\u003eJACC Cardiovasc Interv\u003c/em\u003e. 2019;12(24):2496-2498. doi:10.1016/j.jcin.2019.10.052\u003c/li\u003e\n\u003cli\u003eLeone PP, Chiarito M, Regazzoli D, et al. Prognostic value of tricuspid regurgitation. \u003cem\u003eRev Cardiovasc Med\u003c/em\u003e. 2022;23(2):76. doi:10.31083/j.rcm2302076\u003c/li\u003e\n\u003cli\u003eSeo J, Hong YJ, Batbayar U, et al. Prognostic value of functional tricuspid regurgitation quantified by cardiac magnetic resonance in heart failure. \u003cem\u003eEur Heart J Cardiovasc Imaging\u003c/em\u003e. 2023;24(6):742-750. doi:10.1093/ehjci/jeac224\u003c/li\u003e\n\u003cli\u003evon Ballmoos MCW, Reardon MJ. Surgical treatment of severe tricuspid regurgitation. \u003cem\u003eCurr Opin Cardiol\u003c/em\u003e. 2021;36(5):538-541. doi:10.1097/HCO.0000000000000897\u003c/li\u003e\n\u003cli\u003eMahboobi SK, Sharma S, Ahmed AA. Tricuspid Valve Repair. In: \u003cem\u003eStatPearls\u003c/em\u003e. Treasure Island (FL): StatPearls Publishing; January 19, 2025.\u003c/li\u003e\n\u003cli\u003eMangieri A, Sticchi A, Gohar A, et al. Percutaneous Tricuspid Valve Repair. \u003cem\u003eRev Cardiovasc Med\u003c/em\u003e. 2022;23(7):220. Published 2022 Jun 24. doi:10.31083/j.rcm2307220\u003c/li\u003e\n\u003cli\u003eNickenig G, Lurz P, Sorajja P, et al. Percutaneous Edge-to-Edge Repair for Tricuspid Regurgitation: 3-Year Outcomes From the TRILUMINATE Study. \u003cem\u003eJACC Cardiovasc Interv\u003c/em\u003e. 2024;17(18):2113-2122. doi:10.1016/j.jcin.2024.05.036\u003c/li\u003e\n\u003cli\u003eManpal Kaur Sandhu, Nain Kamal Aulakh, Mira Srihastini Aridas, Aayush Aayush, Srijamya Srijamya. Percutaneous Intervention for Tricuspid Regurgitation: A Systematic Review of Early Clinical Trials . PROSPERO 2025 CRD420251084853. Available from https://www.crd.york.ac.uk/PROSPERO/view/CRD420251084853.\u003c/li\u003e\n\u003cli\u003eReddy YNV, Alkhouli M, Nishimura RA. Isolated severe tricuspid regurgitation: an unrecognised and undertreated problem of the forgotten valve. \u003cem\u003eHeart\u003c/em\u003e. 2021;107(5):350-352. doi:10.1136/heartjnl-2020-318399 \u003c/li\u003e\n\u003cli\u003eIrwin RB, Luckie M, Khattar RS. Tricuspid regurgitation: contemporary management of a neglected valvular lesion. \u003cem\u003ePostgrad Med J\u003c/em\u003e. 2010;86(1021):648-655. doi:10.1136/pgmj.2009.090886\u003c/li\u003e\n\u003cli\u003eWang P, Huang Y, Sun L, Han Z. Surgical Treatment Strategy of Functional Tricuspid Regurgitation. \u003cem\u003eRev Cardiovasc Med\u003c/em\u003e. 2024;25(5):182. Published 2024 May 21. doi:10.31083/j.rcm2505182\u003c/li\u003e\n\u003cli\u003eShimoda TM, Ueyama HA, Miyamoto Y, et al. Comparison of Transcatheter Versus Surgical Tricuspid Repair Among Patients With Tricuspid Regurgitation: Two-Year Results. \u003cem\u003eCirc Cardiovasc Interv\u003c/em\u003e. 2025;18(1):e014825. doi:10.1161/CIRCINTERVENTIONS.124.014825\u003c/li\u003e\n\u003cli\u003eKodali SK, Hahn RT, Davidson CJ, et al. 1-Year Outcomes of Transcatheter Tricuspid Valve Repair. \u003cem\u003eJ Am Coll Cardiol\u003c/em\u003e. 2023;81(18):1766-1776. doi:10.1016/j.jacc.2023.02.049\u003c/li\u003e\n\u003cli\u003eKodali S, Hahn RT, Eleid MF, et al. Feasibility Study of the Transcatheter Valve Repair System for Severe Tricuspid Regurgitation. \u003cem\u003eJ Am Coll Cardiol\u003c/em\u003e. 2021;77(4):345-356. doi:10.1016/j.jacc.2020.11.047\u003c/li\u003e\n\u003cli\u003ePlaner D, Beeri R, Danenberg HD. First-in-Human Transcatheter Tricuspid Valve Repair: 30-Day Follow-Up Experience With the Mistral Device. \u003cem\u003eJACC Cardiovasc Interv\u003c/em\u003e. 2020;13(18):2091-2096. doi:10.1016/j.jcin.2020.05.050\u003c/li\u003e\n\u003cli\u003eDavidson CJ, Lim DS, Smith RL, et al. Early Feasibility Study of Cardioband Tricuspid System for Functional Tricuspid Regurgitation: 30-Day Outcomes. \u003cem\u003eJACC Cardiovasc Interv\u003c/em\u003e. 2021;14(1):41-50. doi:10.1016/j.jcin.2020.10.017\u003c/li\u003e\n\u003cli\u003eNickenig G, Weber M, Sch\u0026uuml;ler R, et al. Tricuspid valve repair with the Cardioband system: two-year outcomes of the multicentre, prospective TRI-REPAIR study. \u003cem\u003eEuroIntervention\u003c/em\u003e. 2021;16(15):e1264-e1271. Published 2021 Feb 5. doi:10.4244/EIJ-D-20-01107\u003c/li\u003e\n\u003cli\u003eGray WA, Abramson SV, Lim S, et al. 1-Year Outcomes of Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study. \u003cem\u003eJACC Cardiovasc Interv\u003c/em\u003e. 2022;15(19):1921-1932. doi:10.1016/j.jcin.2022.07.006\u003c/li\u003e\n\u003cli\u003eBlasco-Turri\u0026oacute;n S, Briedis K, Est\u0026eacute;vez-Loureiro R, et al. Bicaval TricValve Implantation in Patients With Severe Symptomatic Tricuspid Regurgitation: 1-Year Follow-Up Outcomes. \u003cem\u003eJACC Cardiovasc Interv\u003c/em\u003e. 2024;17(1):60-72. doi:10.1016/j.jcin.2023.10.043\u003c/li\u003e\n\u003cli\u003eWebb JG, Chuang AM, Meier D, et al. Transcatheter Tricuspid Valve Replacement With the EVOQUE System: 1-Year Outcomes of a Multicenter, First-in-Human Experience. \u003cem\u003eJACC Cardiovasc Interv\u003c/em\u003e. 2022;15(5):481-491. doi:10.1016/j.jcin.2022.01.280\u003c/li\u003e\n\u003cli\u003eZhang Y, Lu F, Li W, et al. A first-in-human study of transjugular transcatheter tricuspid valve replacement with the LuX-Valve Plus system. \u003cem\u003eEuroIntervention\u003c/em\u003e. 2023;18(13):e1088-e1089. Published 2023 Feb 6. doi:10.4244/EIJ-D-22-00517\u003c/li\u003e\n\u003cli\u003eTabata N, Weber M, Tsujita K, Sinning JM, Nickenig G. Combined Percutaneous Therapy for Tricuspid Regurgitation Using the Cardioband and PASCAL System in 1 Procedure. \u003cem\u003eJACC Cardiovasc Interv\u003c/em\u003e. 2019;12(22):e197-e198. doi:10.1016/j.jcin.2019.07.031\u003c/li\u003e\n\u003cli\u003eNickenig G, Lurz P, Sorajja P, et al. Percutaneous Edge-to-Edge Repair for Tricuspid Regurgitation: 3-Year Outcomes From the TRILUMINATE Study. \u003cem\u003eJACC Cardiovasc Interv\u003c/em\u003e. 2024;17(18):2113-2122. doi:10.1016/j.jcin.2024.05.036\u003c/li\u003e\n\u003cli\u003ePonna PK, Patin S, Turaga NSS, et al. Transcatheter interventions for severe tricuspid regurgitation: a literature review. \u003cem\u003eJ Geriatr Cardiol\u003c/em\u003e. 2022;19(7):539-550. doi:10.11909/j.issn.1671-5411.2022.07.010\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Tricuspid regurgitation, Valve replacement, Annuloplasty, Edge-to-edge repair","lastPublishedDoi":"10.21203/rs.3.rs-7684936/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7684936/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e\u003cp\u003eTricuspid Regurgitation is a prevalent and often undertreated valvular condition associated with poor prognosis when severe. Surgical intervention carries a high operative risk, especially in older patients or those with right ventricular dysfunction. In recent years, multiple percutaneous or transcatheter tricuspid valve interventions have emerged as alternatives, especially for patients who are considered unsuitable for surgery or at high surgical risk.\u003c/p\u003e\u003ch2\u003eMethod\u003c/h2\u003e\u003cp\u003e This systemic review was conducted in accordance with PRISMA guidelines. A comprehensive search of PubMed, Cochrane Library, and ClinicalTrial.gov identified 74 articles, of which 9 early clinical trials were included. Data extraction and pooling was done, and analysis was performed based on functional outcomes like NYHA class, 6-minute walk distance along with quality of life, adverse events, and all-cause mortality.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e\u003cp\u003eThe procedural success rates across these early phase trials were consistently high (85% to 100%). Improvements in NYHA class were observed in 62% to 92% of patients, alongside meaningful gains in functional capacity and quality of life. Edge-to-edge repair devices demonstrated the most consistent functional benefit (91% NYHA improvement, mean\u0026thinsp;+\u0026thinsp;85.5 m in 6MWA, +\u0026thinsp;17 KCCQ points), whereas valve replacement systems achieved reliable anatomical reduction with modest functional gains, and Mistral device showed marked improvements in a small feasibility cohort. The mortality rates were low but varied across the studies.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e\u003cp\u003eEarly phase clinical trials demonstrated high procedural success rate, considerable improvement in functional status and quality of life. Larger randomized trials with extended follow-up are needed to confirm device durability and long-term clinical benefits.\u003c/p\u003e","manuscriptTitle":"Percutaneous interventions for Tricuspid Regurgitation: A systematic review of early clinical trials","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-10-29 04:01:29","doi":"10.21203/rs.3.rs-7684936/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"00c04a9a-b4df-403c-86cb-78a0e5a40f65","owner":[],"postedDate":"October 29th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2026-03-31T10:10:14+00:00","versionOfRecord":[],"versionCreatedAt":"2025-10-29 04:01:29","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7684936","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7684936","identity":"rs-7684936","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}