Interventional procedure overview of transcatheter tricuspid valve leaflet repair for tricuspid regurgitation
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Appendix
The following table outlines the studies that are considered potentially relevant to the IP overview but were not included in the summary of the key evidence. It is by no means an exhaustive list of potentially relevant studies.
Case reports, case series with fewer than 10 patients and reviews that were published before 2020 have not been included.
Article | Number of patients/ follow up | Direction of conclusions | Reasons for non-inclusion in summary of key evidence section |
|---|---|---|---|
Ali FM, Ong G, Edwards J et al. (2021) Comparison of transcatheter tricuspid valve repair using the MitraClip NTR and XTR systems. International Journal of Cardiology 327: 156–62 | Non-randomised comparative study n=40 Follow up=30 days | Both systems were safe and effective. The XTR system allowed treatment of larger coaptation gaps, greater mean reduction in tricuspid regurgitation grade, with more effective reduction of torrential tricuspid regurgitation. | Small study, comparing 2 different systems. |
Arora L, Krishnan S, Subramani S et al. (2021) Functional tricuspid regurgitation: analysis of percutaneous transcatheter techniques and current outcomes. Journal of Cardiothoracic and Vascular Anesthesia 35: 921–31 | Review | Patients currently having transcatheter intervention are typically at high surgical risk and have severe functional tricuspid regurgitation in the absence of severely impaired right ventricular systolic function. Although there are limitations to the transcatheter options currently available for patients, the initial data show that these existing devices are relatively safe with good results and functional improvements. Further investigation is needed to optimise indications, patient selection, anatomic eligibility, long-term outcome, and procedural timing for each device category. | Review |
Aurich M, Volz MJ, Mereles D et al. (2021) Initial experience with the PASCAL Ace Implant System for treatment of severe tricuspid regurgitation. Circulation: Cardiovascular Interventions 14: e010770 | Case series n=16 Follow up=4 weeks | Tricuspid valve leaflet repair using the transcatheter PASCAL Ace implant system has the potential to improve clinical status and right heart reverse remodelling in patients with severe tricuspid regurgitation. | Small case series with short follow up. |
Ben Ali W, Ruf T, Perrin N et al. (2021) Indications, limitations and development of tricuspid valve interventions in adults. The Canadian Journal of Cardiology https://doi.org/10.1016/j.cjca.2021.08.013 | Review | Procedures can be categorised into coaptation devices, annuloplasty devices, transcatheter tricuspid valve replacement, heterotopic caval valve implantation and tricuspid valve-in-valve. Despite the late referral and the patient's profile, there is good procedural device success, excellent safety profile and sustained reduction of regurgitation up to 1 year. As results are limited to the mid-term, TTVIs durability will need to be established before broader adoption of these technologies. | Review |
Besler C, Unterhuber M, Rommel K-P et al. (2020) Nutritional status in tricuspid regurgitation: implications of transcatheter repair. European Journal of Heart Failure 22: 1826–36 | Case series n=86 Follow up=median 6 months | Nutritional impairment is common and of prognostic importance in patients who have transcatheter repair. Hepatorenal function modestly improves after a successful procedure. Further study of extracardiac implications of tricuspid regurgitation-associated right heart failure is warranted to improve care in this vulnerable patient population. | Small case series, focusing on nutritional status. |
Besler C, Blazek S, Rommel K-P et al. (2018) Combined mitral and tricuspid versus isolated mitral valve transcatheter edge-to-edge repair in patients with symptomatic valve regurgitation at high surgical risk. JACC. Cardiovascular Interventions 11: 1142–51 | Non-randomised comparative study n=61 Follow up=up to 18 months | Combined transcatheter mitral plus tricuspid valve edge-to-edge repair appears superior to transcatheter mitral valve edge-to-edge repair alone in terms of cardiac output and functional improvement early after the intervention and improves clinical outcome up to 18 months of follow up. | Small study, focusing on combination of mitral valve and tricuspid valve intervention. |
Besler C, Orban M, Rommel K-P et al. (2018) Predictors of procedural and clinical outcomes in patients with symptomatic tricuspid regurgitation undergoing transcatheter edge-to-edge repair. JACC. Cardiovascular Interventions 11: 1119–28 | Case series n=117 Follow up=median 184 days | Successful tricuspid regurgitation reduction by transcatheter tricuspid valve edge-to-edge repair serves as a predictor for reduced mortality and heart failure hospitalisation. Coaptation gap and jet location may assist in decision making whether a patient is anatomically suited for the procedure. | More recent studies are included. |
Braun D, Nabauer M, Orban M et al. (2017) Transcatheter treatment of severe tricuspid regurgitation using the edge-to-edge repair technique. EuroIntervention 12: e1837-e1844 | Case series n=18 Follow up=30 days | The short-term durability of tricuspid regurgitation reduction appeared promising, and most patients improved clinically. Further studies with larger patient populations and longer follow up have to define the role of this novel treatment option for patients with right-sided heart failure and severe tricuspid regurgitation. | Small case series with short follow up. |
Chang CC, Veen KM Hahn RT et al. (2020) Uncertainties and challenges in surgical and transcatheter tricuspid valve therapy: a state-of-the-art expert review. European Heart Journal 41: 1932–40 | Review | Although early safety and efficacy results are encouraging, remaining uncertainties including grade of tricuspid regurgitation severity (quantitative and qualitative), patient selection, risk stratification, timing of intervention, and definition of successful repair warrant further investigations. | Review |
Corpataux N, Winkel MG, Kassar M et al. (2020) The PASCAL device-early experience with a leaflet approximation device: what are the benefits/limitations compared with the MitraClip? Current Cardiology Reports 22: 74 | Review | The PASCAL system is a valuable addition to the armamentarium of transcatheter mitral and tricuspid valve repair devices. Randomised head-to-head comparisons and long-term data are needed to confirm the promising results seen so far. | Review |
Curio J, Abulgasim K, Kasner M et al. (2020) Intracardiac echocardiography to enable successful edge-to-edge transcatheter tricuspid valve repair in patients with insufficient TEE quality. Clinical Hemorheology and Microcirculation 76: 199–210 | Case series n=11 Follow up=30 days | Intracardiac echocardiography guidance may offer an additional tool to guide edge-to-edge transcatheter tricuspid valve repair with the MitraClip device in patients with poor transoesophageal echocardiography quality. | Small case series, focusing on the use of intracardiac echo-cardiography. |
Donatelle M, Ailawadi G (2020) Transcatheter tricuspid valve repair: Bringing the forgotten valve into the spotlight. The Journal of Thoracic and Cardiovascular Surgery 160: 1467–73 | Review | It is evident that patients with significant tricuspid regurgitation must be identified earlier and referred to reference centres with expertise in the medical, surgical, as well as transcatheter approaches for treating the tricuspid valve specifically before the onset of torrential tricuspid regurgitation or severe right-sided heart failure symptoms. | Review |
Fam NP, Braun D, von Bardeleben RS et al. (2019) Compassionate use of the PASCAL transcatheter valve repair system for severe tricuspid regurgitation: a multicenter, observational, first-in-human experience. JACC. Cardiovascular Interventions 12: 2488–95 | Case series n=28 Follow up=30 days | This first-in-human experience evaluating transcatheter tricuspid repair with the PASCAL system showed high procedural success, acceptable safety, and significant clinical improvement. Larger prospective studies with long-term follow up are needed. | Small case series with short follow up, included in the systematic review by Montalto et al. (2020). |
Faries CM, Sengupta A, Alexis SL et al. (2020) Transcatheter tricuspid and pulmonary valve repair and replacement. Surgical Technology International 36: 217–23 | Review | Challenges faced in TTVI device and trial designs include heterogeneous patient populations, the need for quality imaging, variations of imaging requirements and anatomic criteria by device, hard-to-define clinical endpoints, and the poor prognosis carried by significant residual tricuspid regurgitation. | Review |
Gupta T, Wyler von Ballmoos MC, Goel SS (2021) Transcatheter treatment of severe tricuspid regurgitation. Current Opinion in Cardiology 36: 525–37 | Review | Early results with both repair and replacement technologies have shown promising results. Ongoing pivotal studies will shed light on prognostic benefits compared with medical therapy and hopefully provide long-term data. Some important future perspectives in the field include improved preprocedural planning and intraprocedural imaging, standardisation of echocardiographic measures and clinical endpoints for device trials; disease stage and anatomy tailored approach; and defining the optimal timing of treatment. | Review |
Kaple RK, Agarwal V, Azarbal A et al. (2021) Tricuspid clip implantation using the MitraClip system-A step-by-step guide. Catheterization and Cardiovascular Interventions DOI: 10.1002/ccd.29796 | Review | The use of the MitraClip system on the tricuspid valve has been shown to be a safe and effective treatment strategy in patients with symptomatic tricuspid regurgitation. | Review |
Karam N, Mehr M, Taramasso M et al. (2020) Value of echocardiographic right ventricular and pulmonary pressure assessment in predicting transcatheter tricuspid repair outcome. JACC. Cardiovascular Interventions 13: 1251–61 | Subanalysis of TriValve registry n=249 Follow up=1 year | Transcatheter tricuspid valve repair provided clinical improvement, with 1-year survival free from hospital readmission >75% in patients with severe tricuspid regurgitation. Conventional echocardiographic parameters used to assess right ventricular function and systolic pulmonary artery pressure did not predict clinical outcome. | Subanalysis of TriValve registry. |
Karam N, Braun D, Mehr M et al. (2019) Impact of transcatheter tricuspid valve repair for severe tricuspid regurgitation on kidney and liver function. JACC. Cardiovascular Interventions 12: 1413–20 | Case series n=126 Follow up=6 months | Tricuspid regurgitation reduction by transcatheter tricuspid valve repair is associated with an improvement in liver function, mainly among patients with abnormal liver function at baseline, whereas kidney function remained stable. | Studies with more patients or longer follow up are included. |
Kavsur R, Hupp-Herschel HE, Sugiura A et al. (2021) Prognostic significance of the get with the guidelines-heart failure (GWTG-HF) risk score in patients undergoing trans-catheter tricuspid valve repair (TTVR). Heart Vessels https://doi.org/10.1007/s00380-021-01874-3 | Case series n=181 | The 'get with the guidelines-heart failure' score serves as a risk assessment tool in patients with heart failure and concomitant severe tricuspid regurgitation who have transcatheter tricuspid valve repair to predict 1 year mortality and hospitalisations for heart failure. The inclusion of NT-proBNP led to an improvement of the score's predictive power, emphasising its use in this patient population. Overall, in this present study, the procedure was feasible in most patients and led to a substantial improvement of tricuspid regurgitation and NYHA classes. | Study focuses on the Get-With-The-Guidelines-Heart-Failure (GWTG-HF) score as a risk assessment tool. |
Kavsur R, Hupp H, Sugiura A et al. (2020) Pulmonary capillary wedge pressure (PCWP) as prognostic indicator in patients undergoing transcatheter valve repair (TTVR) of severe tricuspid regurgitation. International Journal of Cardiology 318: 32–8 | Case series n=60 Follow up=6 months | PCWP is a predictive outcome parameter in TTVR patients. Patients with a PCWP ≤16 mmHg had a favourable outcome with lower mortality and morbidity gaining more benefit of TTVR. | Small case series. |
Kitamura M, Thiele H, Lurz P et al. (2021) 12-Month outcomes of transcatheter tricuspid valve repair with the PASCAL system for severe tricuspid regurgitation. Catheterization and Cardiovascular Interventions 97: 1281–89 | Case series n=30 Follow up=12 months | 12-month outcomes showed high procedural success, acceptable safety, and significant clinical improvement. | Small case series |
Kodali S, Hahn RT, Eleid MF et al. (2021) Feasibility study of the transcatheter valve repair system for severe tricuspid regurgitation. Journal of the American College of Cardiology 77: 345–56 | Case series n=34 Follow up=30 days | The repair system performed as intended, with substantial tricuspid regurgitation reduction, favourable safety results with a low major adverse event rate, no mortality or reintervention, and statistically significant improvements in functional status, exercise capacity, and quality of life. | Small case series, included in the systematic review by Montalto et al. (2020). |
Kolte D, Elmariah S (2020) Current state of transcatheter tricuspid valve repair. Cardiovascular Diagnosis and Therapy 10: 89–97 | Review | The short- and mid-term data on the safety and efficacy of various transcatheter tricuspid valve therapies are encouraging. Procedural and clinical outcomes are expected to improve in the coming years with technological advancement, newer device iterations, and increased experience in this field. Appropriate patient selection, optimal timing of intervention, and evaluation of long-term outcomes and device durability will be key in ongoing and future studies. | Review |
Kresoja K-P, Rommel K-P, Unterhuber M et al. (2021) Right ventricular contraction patterns in patients undergoing transcatheter tricuspid valve repair for severe tricuspid regurgitation. JACC: Cardiovascular Interventions 14: 1551–61 | Cohort study n=79 Follow up=median 362 days | Global right ventricular dysfunction is a predictor of outcomes among patients who have transcatheter tricuspid valve repair. Tricuspid regurgitation patients can be stratified into 3 types of right ventricular contraction, in which a loss of longitudinal function can be compensated by increasing circumferential function, preserving right ventricular ejection fraction and favourable outcomes. | Studies with more patients or longer follow up are included. |
Kresoja K-P, Lauten A, Orban M et al. (2020) Transcatheter tricuspid valve repair in the setting of heart failure with preserved or reduced left ventricular ejection fraction. European Journal of Heart Failure 22: 1817–25 | Cohort study n=111 and 94 pairs in propensity-matched cohort Follow up=median 238 days | Transcatheter tricuspid valve edge-to-edge repair might be a treatment option in patients with severe tricuspid regurgitation and left-sided heart failure with preserved (≥50%) ejection fraction compared to conservative therapy. | Studies with more patients or longer follow up are included. |
Lurz P, Orban M, Besler C et al. (2020) Clinical characteristics, diagnosis, and risk stratification of pulmonary hypertension in severe tricuspid regurgitation and implications for transcatheter tricuspid valve repair. European Heart Journal 41: 2785–95 | Case series n=243 Follow up=330 days | The discordant echocardiographic and invasive diagnosis of pulmonary hypertension in severe tricuspid regurgitation predicts outcomes after transcatheter tricuspid valve repair. | Studies with more patients or longer follow up are included. |
Lurz P, Besler C, Noack T et al. (2018) Transcatheter treatment of tricuspid regurgitation using edge-to-edge repair: procedural results, clinical implications and predictors of success. EuroIntervention 14: e290-e297 | Case series n=42 Follow up=30 days | Edge-to-edge repair of the tricuspid valve is feasible with a promising reduction in tricuspid regurgitation, which could result in clinical improvement. | Studies with more patients or longer follow up are included. |
Mahowald MK, Pislaru SV, Reeder GS et al. (2020) Institutional learning experience for combined edge-to-edge tricuspid and mitral valve repair. Catheterization and Cardiovascular Interventions 96: 1323–30 | Case series n=22 Follow up=30 days | Combined edge-to-edge tricuspid and mitral valve repair is safe and feasible. With experience, procedure duration and residual tricuspid regurgitation decreased. | Studies with more patients or longer follow up are included. |
Mega S, Ussia GP, Grigioni F et al. (2021) Mitral and tricuspid valves percutaneous repair in patients with advanced heart failure: panacea, or Pandora's box? Heart Failure Clinics 17: 607–618 | Review | In heart failure with reduced ejection fraction, the advent of transcatheter therapies to address secondary (functional) mitral and tricuspid regurgitation offers new therapeutic opportunities. Edge-to-edge tricuspid repair is the most developed transcatheter option currently available for functional tricuspid regurgitation. | Review |
Mehr M, Karam N, Taramasso M et al. (2020) Combined tricuspid and mitral versus isolated mitral valve repair for severe mitral and tricuspid regurgitation: an analysis from the TriValve and TRAMI Registries. JACC. Cardiovascular Interventions 13:543–50 | Analysis of registry data n=228 Follow up=1 year | Concurrent transcatheter mitral and tricuspid valve repair was associated with a higher 1‐year survival rate compared with isolated transcatheter mitral valve repair in patients with both mitral and tricuspid regurgitation. Further randomised trials are needed to confirm these results. | Study focuses on patients with mitral valve repair with or without tricuspid valve repair. |
Meijerink F, Koch KT, de Winter RJ et al. (2021) Transcatheter tricuspid valve repair: early experience in the Netherlands. Netherlands Heart Journal 29: 595–603 | Case series n=21 Follow up=4 weeks | Transcatheter tricuspid valve repair seems a promising treatment option for patients with severe functional tricuspid regurgitation deemed high risk for surgery. Successful tricuspid regurgitation reduction is most likely in patients with limited coaptation gap size and strongly determines clinical benefit. Adequate patient selection and timing of treatment seem essential for an optimal patient outcome | Small case series |
Miura M, Alessandrini H, Alkhodair A et al. (2020) Impact of massive or torrential tricuspid regurgitation in patients undergoing transcatheter tricuspid valve intervention. Cardiovascular Interventions 13: 1999–2009 | Subanalysis of TriValve registry n=333 Follow up: median 237 days | Baseline massive or torrential tricuspid regurgitation is associated with an increased risk for all-cause mortality and rehospitalisation for heart failure 1 year after TTVI. Procedural success is related to better outcomes, even in the presence of baseline massive or torrential tricuspid regurgitation. | Subanalysis of TriValve registry, focusing on patients with massive or torrential tricuspid regurgitation. |
Muntane-Carol G, Philippon F, Puri R et al. (2021) Transcatheter tricuspid valve intervention in patients with previous left valve surgery. Canadian Journal of Cardiology 37: 1094–1102 | Subanalysis of TriValve registry n=82 | In patients with previous left valve surgery, TTVI was associated with high rates of procedural success and low early mortality. However, about a third of patients needed rehospitalisation or died at midterm follow up. | Subanalysis of TriValve registry, focusing on patients with previous left valve surgery. |
Muntane-Carol G, Philippon F, Puri R et al. (2021) Transcatheter tricuspid valve intervention in patients with right ventricular dysfunction or pulmonary hypertension: insights from the TriValve registry. Circulation: Cardiovascular Interventions 184–92 | Subanalysis of TriValve registry n=300 | The TTVI was associated with high procedural success and a relatively low in-hospital mortality, along with improvements in functional status. However, about 1 out of 5 patients died after a median follow up of 6 months, with hepatic congestion and renal dysfunction. The lack of procedural success determined an increased risk. These results may improve the clinical evaluation of TTVI candidates and would suggest a closer follow up in those at increased risk. | Subanalysis of TriValve registry, focusing on patients with right ventricular dysfunction or pulmonary hypertension. |
Muntane-Carol G, Alperi A, Faroux L et al. (2021) Transcatheter interventions for tricuspid valve disease: what to do and who to do It on. Canadian Journal of Cardiology 37: 953–67 | Review | The initial experience showed that most procedures were well tolerated, with high procedural success and low in-hospital and early mortality. Also, most patients improved their functional status and recent data suggest improved outcomes compared with medical management. However, the rate of significant residual tricuspid regurgitation after transcatheter tricuspid valve repair remains high and very scarce data exist on longer term (beyond 6 to 12 months) outcomes. | Review |
Muntane-Carol G, Del Val D, Bedard E et al. (2019) Transcatheter innovations in tricuspid regurgitation: FORMA device. Progress in Cardiovascular Diseases 62: 496–99 | review of 2 cohort studies n=47 Follow up=1 and 12 months | Initial experience with the FORMA device in prohibitive surgical risk patients showed the feasibility of this procedure, albeit with a reasonable rate of device-related complications. The magnitude of tricuspid regurgitation reduction was moderate at long-term and there were improvements in heart failure symptoms and quality of life. | Studies with more patients or longer follow up are included. |
Nagaraja V, Kapadia SR, Miyasaka R et al. (2020) Contemporary review of percutaneous therapy for tricuspid valve regurgitation. Expert Review of Cardiovascular Therapy 18: 209–18 | Review | The early data available thus far on percutaneous tricuspid repair and replacement is promising and shows modest reductions in tricuspid regurgitation along with improvement in the quality of life. Different from transcatheter aortic valve intervention, percutaneous tricuspid repair and replacement does not have long-term data. The lack of standardised protocols and definitions for enrolment and outcomes in these early tricuspid trials are a limitation. | Review |
Nagaraja V, Mohananey D, Navia J et al. (2020) Functional tricuspid regurgitation: Feasibility of transcatheter interventions. Cleveland Clinic Journal of Medicine 87: 4–14 | Review | The published data so far on percutaneous therapies show promising results in the form of a reasonable reduction in tricuspid regurgitation along with substantial improvement in the quality of life. The transcatheter device technology is currently evolving for the tricuspid valve. Patient selection based on anatomy for the appropriate device technology is imperative. Improved device technology best matched to patient factors is likely to increase the array of options available. | Review |
Nickenig G, Weber M, Lurz P et al. (2019) Transcatheter edge-to-edge repair for reduction of tricuspid regurgitation: 6-month outcomes of the TRILUMINATE single-arm study. Lancet 394: 2002–11 | Single arm trial n=85 Follow up=6 months | The TriClip system appears to be safe and effective at reducing tricuspid regurgitation by at least one grade. This reduction could translate to significant clinical improvement at 6 months post procedure. | A more recent report from the same trial is included (Lurz, 2021). Study is included in the systematic review by Montalto et al. (2020). |
Nickenig G, Kowalski M, Hausleiter J et al. (2017) Transcatheter treatment of severe tricuspid regurgitation with the edge-to-edge MitraClip technique. Circulation 135: 1802–14 | Case series n=64 Follow up=30 days | Transcatheter treatment of tricuspid regurgitation with the MitraClip system seems to be safe and feasible in this cohort of preselected patients. Initial efficacy analysis showed encouraging reduction of tricuspid regurgitation, which may potentially result in improved clinical outcomes. | Studies with more patients or longer follow up are included. |
Orban M, Rommel KP, Ho EC et al. (2020) Transcatheter edge-to-edge tricuspid repair for severe tricuspid regurgitation reduces hospitalizations for heart failure. JACC. Heart Failure 8: 265–76 | Cohort study n=233 Follow up=median 360 days | Transcatheter edge-to-edge tricuspid repair for severe TR is associated with a reduction of hospitalisations for heart failure and improved clinical outcomes. Patients who had transcatheter mitral and tricuspid valve repair had comparable outcomes. | Studies with more patients or longer follow up are included. |
Orban M, Orban MW Braun D et al. (2019) Clinical impact of elevated tricuspid valve inflow gradients after transcatheter edge-to-edge tricuspid valve repair. EuroIntervention 15: e1057-e1064 | Cohort study n=145 Follow up=1 year | A small cohort of patients showed an elevated tricuspid valve gradient higher than 3 mmHg at discharge. This elevation had no impact on clinical improvement, mortality or hospitalisation for heart failure. | Studies with more patients or longer follow up are included. |
Orban M, Besler C, Braun D et al. (2018) Six-month outcome after transcatheter edge-to-edge repair of severe tricuspid regurgitation in patients with heart failure. European Journal of Heart Failure 20: 1055–62 | Case series n=50 Follow up=6 months | Transcatheter edge-to-edge tricuspid valve repair for severe TR is safe and effective in reducing TR. It appears to be associated with improved clinical outcome in most patients. | Studies with more patients or longer follow up are included. |
Otto S, Velichkov M, Hamadanchi A et al. (2021) The impact of tricuspid annular geometry on outcome after percutaneous edge-to-edge repair for severe tricuspid regurgitation. Cardiology Journal 28: 579–88 | Case series n=20 Follow up=30 days | No differences in conventional echocardiographic parameters for TR severity but more dilated tricuspid annulus geometry (tricuspid valve annulus, coaptation depth, tenting area) in the failed repair group were seen. | Small case series |
Perlman G, Praz F, Puri R et al. (2017) Transcatheter tricuspid valve repair with a new transcatheter coaptation system for the treatment of severe tricuspid regurgitation: 1-Year clinical and echocardiographic results. JACC. Cardiovascular Interventions 10: 1994–2003 | Case series n=18 Follow up=1 year | Implantation of the FORMA system in high-risk patients with severe TR shows feasibility with a good mid-term safety profile. At 1 year, despite variable success in reducing echocardiographic TR grade, there were significant clinical improvements and reductions in right ventricular dimensions. | Small case series, included in the systematic review by Montalto et al. (2020). |
Rahgozar K, Ho E, Goldberg Y et al. (2021) Transcatheter tricuspid valve repair and replacement: a landscape review of current techniques and devices for the treatment of tricuspid valve regurgitation. Expert Review of Cardiovascular Therapy 19: 399–411 | Review | There is currently an unmet clinical need in the treatment of severe tricuspid regurgitation, but this paradigm is slowly shifting and the number of TTVIs is climbing each year. Promising early results with many of the devices and techniques available have shown the feasibility, safety, and short-term efficacy of transcatheter tricuspid valve repair. | review |
Rommel K-P, Besler C, Noack T et al. (2019) Physiological and clinical consequences of right ventricular volume overload reduction after transcatheter treatment for tricuspid regurgitation. JACC. Cardiovascular Interventions 12: 1423–34 | Case series n=29 Follow up=6 months | Transcatheter tricuspid valve repair reduces chronic right ventricular volume overload without increase in right ventricular afterload, improves right ventricular performance and left ventricular filling, and enhances cardiac output. These changes translate into symptomatic and functional improvement. These implications for biventricular physiology and clinical status are maintained at 6 months follow up. | Small case series |
Ruf TF, Kreidel F, Hell M et al. (2021) Short-term clinical outcomes of transcatheter tricuspid valve repair with the third-generation MitraClip XTR system. JACC: Cardiovascular Interventions 14: 1231–40 | Case series n=50 Follow up=30 days | MitraClip XTR implantation is a safe, effective treatment for a wider range of coaptation gap sizes in patients with symptomatic, significant TR than prior device iterations. All patients showed improvement in NYHA functional class, and those with coaptation gap size less than 10 mm also had improved functional capacity. | Small case series |
Santalo-Corcoy M, Asmarats L, Arzamendi D et al. (2020) Catheter-based treatment of tricuspid regurgitation: State of the art. Annals of Translational Medicine 8: 964 | Review | Preliminary data has shown encouraging results, with significant functional and echocardiographic improvements. Further studies are greatly awaited to provide the necessary background to determine the optimal time and devices to intervene in this less symptomatic population, along with a deeper knowledge of the long-term performance of the variety of technologies currently used in different stages of the disease. | Review |
Schlotter F, Rommel K-P, Besler C et al. (2019) Aetiology-based clinical scenarios predict outcomes of transcatheter edge-to-edge tricuspid valve repair of functional tricuspid regurgitation. European Journal of Heart Failure 21: 1117–25 | Cohort study n=164 Follow up=median 248 days | Stratification of transcatheter tricuspid valve repair into aetiology-based clinical scenarios may open new paths to stratify for clinical risk and procedural benefit and may aid in the design of clinical trials in the heterogeneous patient population. Despite the observed clinical scenario outcome differences, it appears feasible and safe, and confers functional improvements in patients with TR and heart failure. | Studies with more patients or longer follow up are included. |
Stocker TJ, Hertell H, Orban M et al. (2021) Cardiopulmonary hemodynamic profile predicts mortality after transcatheter tricuspid valve repair in chronic heart failure. JACC. Cardiovascular Interventions 14: 29–38 | Single arm study n=236 Follow up=1 year | Invasive assessment of cardiopulmonary hemodynamic status predicts survival after transcatheter tricuspid valve repair. Invasive hemodynamic characterisation may help identify patients profiting most from the procedure. | The main aim of the study was to assess haemo-dynamic changes and identify haemo-dynamic predictors associated with mortality. |
Sugiura A, Tanaka T, Kavsur R et al. (2021) Leaflet configuration and residual tricuspid regurgitation after transcatheter edge-to-edge tricuspid repair. JACC. Cardiovascular Interventions 14: 2260–70 | Case series n=145 Follow up=30 days | A 4-leaflet configuration of the tricuspid valve was seen in about 33% of people having transcatheter edge-to-edge tricuspid repair, which is associated with an increased risk of residual TR after the procedure. | Study focuses on leaflet configuration. |
Sugiura A, Vogelhuber J, Ozturk C et al. (2021) PASCAL versus MitraClip-XTR edge-to-edge device for the treatment of tricuspid regurgitation: a propensity-matched analysis. Clinical Research in Cardiology 110: 451–9 | Non-randomised comparative study n=80 Follow up=3 months | Both devices, PASCAL and MitraClip-XTR, appeared feasible and comparable for an effective TR reduction. | Studies with more patients or longer follow up are included. |
Tanaka T, Kavsur R, Sugiura A et al. (2021) Prognostic impact of hepatorenal function in patients undergoing transcatheter tricuspid valve repair. Scientific Reports 11: 14420 | Case series n=172 | The model for end-stage liver disease excluding international normalised ratio score was associated with the risk of 1-year composite outcome, consisting of mortality and heart failure hospitalisation, after the procedure and may help risk stratification. | The focus of the study was to assess the prognostic significance of hepatorenal dysfunction. |
Taramasso M, Gavazzoni M, Pozzoli A et al. (2020) Outcomes of TTVI in patients with pacemaker or defibrillator leads: data From the TriValve registry. JACC. Cardiovascular Interventions 13: 554–64 | Subanalysis of TriValve registry n=470 Follow up: median 7 months | TTVI is feasible in selected patients with cardiac implantable electronic device leads and acute procedural success and short-term clinical outcomes are comparable to those seen in patients without a transtricuspid lead. | Subanalysis of TriValve registry, focusing on patients with pacemaker or defibrillator leads. |
Taramasso M, Hahn RT, Alessandrini H et al. (2017) The international multicenter TriValve registry: which patients are undergoing transcatheter tricuspid repair? JACC. Cardiovascular Interventions 10: 1982–90 | TriValve registry n=106 Follow up: 30 days | Patients currently having transcatheter tricuspid valve therapy are mostly high risk, with a functional aetiology and very severe central regurgitation, and do not have severely impaired right ventricular function. Initial results suggest that transcatheter tricuspid valve therapy is feasible with different techniques, but clinical efficacy requires further investigation. | More recent publications with data from the TriValve registry are included. |
Yandrapalli S, Kolte D (2021) Tricuspid regurgitation: when and how to treat. Current Treatment Options in Cardiovascular Medicine 23: 60 | Review | Transcatheter tricuspid valve therapies may offer a less invasive and potentially safer alternative to surgery for managing severe symptomatic tricuspid regurgitation. Ongoing studies will shed light on long-term outcomes and device durability, and inform patient selection and optimal timing of intervention. | Review |
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