Interventional procedure overview of transcatheter tricuspid valve annuloplasty 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.
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 |
|---|---|---|---|
Arnold M, Haug J, Landendinger M (2021) Tricuspid annuloplasty: transcatheter approaches. Current Cardiology Reports 23: 139 | Review | Transcatheter techniques for tricuspid annuloplasty have shown to be safe and the results to be reproducible in the early clinical experience. Surprisingly already minor changes in tricuspid annular dimensions seem to translate into relevant improvement of symptoms and functional status of patients with functional tricuspid regurgitation. This might be because patients with a higher severity of tricuspid regurgitation at a later stage of the disease were selected for the interventional treatment. | Review |
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 |
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 |
Gercek M, Rudolph V, Arnold M et al. (2021) Transient acute right coronary artery deformation during transcatheter interventional tricuspid repair with the Cardioband tricuspid system. EuroIntervention 17: 81–7 | Case series n=14 | Right coronary artery deformation is relatively frequent after interventional tricuspid annuloplasty but appears to be completely reversible in the absence of flow impairment or vascular damage. Based on early experience watchful waiting is the most appropriate strategy to avoid unnecessary coronary interventions. | Small case series, focusing on the persistence and clinical significance of acute right coronary artery deformation. |
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. |
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 (14% annuloplasty) | 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. | Only a small proportion of the patients had a transcatheter tricuspid valve annuloplasty. Most patients had an edge-to-edge repair. |
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 |
Lauri FM, Fernandez-Golfin C, Zamorano JL et al. (2021) Coronary compression caused by extrinsic adventitial damage: case of an early complication of trans-catheter tricuspid annuloplasty with cardioband device. European Heart Journal doi:10.1093/eurheartj/ehab564 | Case report n=1 | A large haematoma causing severe extravascular compression was identified during the procedure and a drug eluting stent was implanted. Intravascular imaging elucidated for the first time that one of the mechanisms of coronary occlusion associated to Cardioband annuloplasty procedure is the extrinsic adventitial damage produced by the anchors that leads to flow-limiting extra-adventitial haematoma. | Case report of a bleeding complication. |
Miura M, Vicentini L, Taramasso M et al. (2021) Tangled wire in a Dacron band during Cardioband transcatheter tricuspid annuloplasty-How to solve the problem. Catheterization and Cardiovascular Interventions 97: e724–26 | Case report n=1 | During the procedure, it was impossible to connect the distal tip of the size adjustment tool and the Dacron band because the cinching wire was tangled around the Dacron band. The issue was resolved without surgical intervention. | Case report of a technical issue. |
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 transcatheter tricuspid valve intervention. Procedural success is related to better outcomes, even in the presence of baseline massive or torrential tricuspid regurgitation. | Only a small proportion of the patients had a transcatheter tricuspid valve annuloplasty. Most patients had an edge-to-edge repair. |
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, transcatheter tricuspid valve intervention 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. | Only a small proportion of the patients had a transcatheter tricuspid valve annuloplasty. Most patients had an edge-to-edge repair. |
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 transcatheter tricuspid valve intervention 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 transcatheter tricuspid valve intervention candidates and would suggest a closer follow up in those at increased risk. | Only a small proportion of the patients had a transcatheter tricuspid valve annuloplasty. Most patients had an edge-to-edge repair. |
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 demonstrates 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 demonstrate 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, Schueler R et al. (2019) 6-month outcomes of tricuspid valve reconstruction for patients with severe tricuspid regurgitation. Journal of the American College of Cardiology 73: 1905–15 | Case series (TRI-REPAIR study) n=30 Follow up: 6 months | The system performed as intended and appeared to be safe in patients with symptomatic and moderate to severe functional tricuspid regurgitation. Significant reduction of tricuspid regurgitation through decrease of annular dimensions, improvements in heart failure symptoms, quality of life, and exercise capacity were observed. Further studies are warranted to validate these initial promising results. | A more recent publication from the same study is included. This study is 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 transcatheter tricuspid valve interventions 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 |
Reddy VY, Petru J, Neuzil P et al. (2020) First-in-human percutaneous circumferential annuloplasty for secondary tricuspid regurgitation. JACC: Case Reports 2: 2176–82 | Case report n=1 Follow up: 1 year | Description of the first fully percutaneous implantation of a circumferential, semirigid annuloplasty ring to treat massive secondary tricuspid regurgitation. The implanted ring maintained its adjusted diameter out to 1 year after adjustment, with no evidence of ring failure. | Case report. |
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 |
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 normalized 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 the risk stratification in patients. | The focus of the study was to assess the prognostic significance of hepatorenal dysfunction. Only a small proportion of the patients had a transcatheter tricuspid valve annuloplasty. |
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 | Transcatheter tricuspid valve intervention is feasible in selected patients with cardiac implantable electronic device leads and acute procedural success and short-term clinical outcomes are comparable to those observed in patients without a transtricuspid lead. | Only a small proportion of the patients had a transcatheter tricuspid valve annuloplasty. Most patients had an edge-to-edge repair. |
Taramasso M, Alessandrini H, Latib A et al. (2019) Outcomes after current transcatheter tricuspid valve intervention: mid-term results from the international TriValve registry. JACC. Cardiovascular Interventions 12: 155–65 | TriValve registry n=312 Follow up: median 6.2 months | Transcatheter tricuspid valve intervention is feasible with different technologies, has a reasonable overall procedural success rate, and is associated with low mortality and significant clinical improvement. Mid-term survival is favourable in this high-risk population. Greater coaptation depth is associated with reduced procedural success, which is an independent predictor of mortality. | Only a small proportion of the patients had a transcatheter tricuspid valve annuloplasty. Most patients had an edge-to-edge repair. |
Taramasso M, Benfari G, van der Bijl P et al. (2019) Transcatheter versus medical treatment of patients with symptomatic severe tricuspid regurgitation. Journal of the American College of Cardiology 74: 2998–3008 | Non-randomised comparative study (using data from TriValve registry) n=268 matched pairs Follow up: 1 year | In this propensity-matched case-control study, transcatheter tricuspid valve intervention was associated with greater survival and reduced heart failure rehospitalisation compared with medical therapy alone. Randomised trials should be done to confirm these results. | Only a small proportion of the patients had a transcatheter tricuspid valve annuloplasty. Most patients had an edge-to-edge repair. |
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. | Only a small proportion of the patients had a transcatheter tricuspid valve annuloplasty. Most patients had an edge-to-edge repair. |
Wosten M, Baldus S, Pfister R (2020) Case report: Transcatheter valve repair with Cardioband: A new treatment option for secondary tricuspid regurgitation in cardiac transplant patients. European Heart Journal - Case Reports 4: ytaa451 | Case report n=1 | Tricuspid regurgitation improved from massive to mild with a mean pressure gradient of 2.9 mmHg. This is the first case report of Cardioband implantation in tricuspid position in a heart transplant patient with the good technical and clinical result, suggesting that this technique might offer a treatment option to highly selected post-transplant patients with secondary severe tricuspid regurgitation and high surgical risk. | Case report of the procedure in a patient who had a previous heart transplant. |
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