Interventional procedure overview of caval valve implantation for tricuspid regurgitation
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Other relevant studies
Other potentially relevant studies to the interventional procedures overview that were not included in the main evidence summary (tables 2 and 3) are listed in table 5.
Article | Number of patients and follow up | Direction of conclusions | Reason study was not included in main evidence summary |
|---|---|---|---|
Aalaei-Andabili SH, Bavry AA, Choi C et al. (2020) Percutaneous inferior vena cava valve implantation may improve tricuspid valve regurgitation and cardiac output: lessons learned. Innovations 15: 577–80 | Case series N=6 patients who could not be operated on with severe TR who failed medical treatment had percutaneous CAVI with 9-mm SAPIEN 3 valve | The procedure was successfully performed in all 6 patients (100%). No procedural complication was detected. At 30 days, TR improved from severe to trace in 1 patient, to mild-moderate in 3 patients, and 2 patients remained with severe TR. Among patients with improved TR, left ventricular ejection fraction increased from 47.5%±18.5% to 55%±20.4% (p=0.014). No patient had readmission at 30 days. Four patients needed rehospitalisation within 6 months. | Large studies with longer follow up included in evidence summary |
Abdul-Jawad Altisent O, and Estévez-Loureiro R (2022) Heterotopic transcatheter tricuspid valve implantation. a promising technology for patients with high-risk TR. CARDIAC INTERVENTIONS TODAY 16 (5): 56–66 | Review | Heterotopic CAVI is a promising technology for patients with high-risk TR and limited treatment options. There are several devices under study, the TricValve gained widespread adoption. The TRICUS EURO study showed a positive effect in clinical outcomes and quality of life. | Review |
Abdul-Jawad Altisent O, Benetis R, Rumbinaite E et al. (2021) Caval valve implantation (CAVI): an emerging therapy for treating severe tricuspid regurgitation. J Clin Med 10: 4601 | Review on CAVI technique | In this review, the current evidence and ongoing uncertainties of CAVI, focusing on the novel CAVI-specific devices was discussed. | Review |
Abdul-Jawad Altisent O, Codina P, Puri R et al. (2022) Transcatheter bi-caval valve implantation (CAVI) significantly improves cardiac output: mechanistic insights following CardioMEMS® and TricValve® implantation. Clin Res Cardiol 111: 966–8 | No abstract provided | ||
Aparisi Á, Amat-Santos IJ, Serrador A et al. (2020) Current clinical outcomes of tricuspid regurgitation and initial experience with the TricValve system in Spain. Rev Esp Cardiol 73: 853–4 | Case report N=2 patients had CAVI with Tricento and with TricValve | Assessment of potential prognostic benefit by bicavally implanted heterotopic prosthesis needs longer-term studies, but initial experience suggests safe and effective procedural and short-term outcomes. | Large studies with longer follow up included in evidence summary |
Asmarats L, Puri R, Latib A et al. (2018) Transcatheter tricuspid valve interventions: landscape, challenges, and future directions. Journal of the American College of Cardiology 71, 25: 2935–56 | Review | The aim of this review is to provide an updated overview and a clinical perspective on novel transcatheter tricuspid valve therapies, highlighting potential challenges and future directions. | Review |
Chandran K, Long A, Bishop J, Berman P et al. (2023) First in-man experience with TricValve transcatheter bicaval valve system in left ventricular assist device Heartmate II patient for high-risk tricuspid regurgitation. Circ Heart Fail 16(6): e010027 | Case report An 80-year-old patient with severe TR and HeartMate had TricValve bicaval valve implantation | Patient reported a significant improvement in her symptoms to NYHA class I to II. She has felt an improvement in her quality of life with rare lower extremity oedema. | Large studies with longer follow up included in evidence summary |
Datta R, Bharadwaj P, Keshavamurthy G et al. (2023) Caval valve implantation: First of its kind in a rare environment. Medical Journal Armed Forces India. Online 8 February | Case report N=1 76-year-old lady with severe TR and recurrent right heart failure had CAVI with TricValve in SVC and IVC | Significant haemodynamic and clinical improvement has been noted in this patient at 3-month follow up. | Large studies with longer follow up included in evidence summary |
Dona C, Goliasch G, Schneider M et al. (2020) Transcatheter TricValve implantation for the treatment of severe tricuspid regurgitation. European Heart Journal - Cardiovascular Imaging online E92 | Case report 78-year-old patient with heart failure and TR had transcatheter TricValve implantation | The valves were successfully deployed. The patient was discharged 3 days after the procedure. At 3 months, her symptoms and exercise capacity had significantly improved. On transthoracic echocardiogram, TR had decreased from torrential to mild-to-moderate. | Large studies with longer follow up included in evidence summary |
Figulla HR, Kiss K, Lauten A (2016) Transcatheter interventions for tricuspid regurgitation - heterotopic technology: TricValve. EuroIntervention 18;12(Y): Y116–8 | Review of concept | CAVI with the TricValve is a relatively simple procedure. However, valve design must cover a great range of caval vein anatomy. The haemodynamic concept is convincing and allows the RV to recover. Clinical experience is presently restricted to compassionate cases. | Review |
Galasso M, Cartella I, Soriano F et al. (2023) Bi-caval valve implantation to palliate symptoms in a case of massive tricuspid regurgitation. Cardiovasc Revasc Med53S: S139–S143 | Case report N=69-year-old man with significant TR and advanced heart failure without surgical options had heterotopic CAVI with TricValve | At 3-months follow up, the patient was alive and an improvement in functional status and heart failure symptoms (NYHA class II) noted. Renal and liver function did not worsen while a significant reduction of loop diuretic dosage was possible. | Large studies with longer follow up included in evidence summary |
Cruz-González I, González-Ferreiro R, Amat-Santos IJ et al. (2021) TRICENTO transcatheter heart valve for severe tricuspid regurgitation. Initial experience and mid-term follow-up. Rev Esp Cardiol 74: 351–4 | Case series N=6 patients with congestive heart failure had TRICENTO valve implantation for severe functional TR | Device was successfully deployed in all without any major complications. During follow up (11±4.4 months), all patients showed NYHA functional class improvement (class I-II). No patients died. One patient was admitted with acute decompensation of heart failure (41 days after the procedure). | Large studies with longer follow up included in evidence summary |
Grazina A, Ferreira A, Ramos R et al. (2023) Heterotopic caval valve-in-valve procedure for prosthetic migration: two case reports. European Heart Journal - Case Reports, 7 (8), 1–7 | Case report N=2 patients with severe TR and high surgical risk who had CAVI, and device migration to the right atrium (1 IVC and 1 SVC device) had treatment with a caval valve-in-valve procedure. | Both cases reported good technical and clinical results. | Caval valve-in-valve-study |
Jin QW, Mohd Ghazi AB, Kolanthaivelu J et al. (2022) Novel treatment of atrial functional tricuspid regurgitation using transcatheter bicaval valve implantation (TricValve). Asia Intervention 6;8(2): 138–42 | Case report N=67-year-old woman with underlying atrial fibrillation and severe TR had CAVI with TricValve | The procedure was uneventful and the patient was discharged. At 3-month follow up, there was marked improvement clinically and biochemically. | Large studies with longer follow up included in evidence summary |
Kultursay B, Bingol G, Guven B et al. (2022) TricValve pop-out: management of transcatheter caval valve migration. Anatol J Cardiol 26: 414–8 | Case report | At the time of deployment, the IVC valve migrated into the right atrium. There was no hemodynamical worsening after migration of the valve. Deployment of another IVC valve protruding into the right atrium and overlapping the popped-out valve was done. After successful deployment of the second IVC valve, no paravalvular leak or caval backflow was seen. Significant improvement in functional capacity was seen at 3-months follow up. | Large studies with longer follow up included in evidence summary |
Lauten A, Ferrari M, Hekmat K et al. (2011) Heterotopic transcatheter tricuspid valve implantation: first-in man application of a novel approach to tricuspid regurgitation. Eur Heart J 32: 1207–13 | Case report N=1 patient with severe functional TR after multiple preceding open heart procedures, a self-expanding valve was implanted into the IVC at the cavoatrial junction to reduce regurgitant backflow | Excellent valve function was seen after deployment resulted in a marked reduction of caval pressure and an abolition of backflow to the IVC. | Large studies with longer follow up included in evidence summary |
Lauten A, Hamadanchi A, Doenst T et al. (2014) Caval valve implantation for treatment of tricuspid regurgitation: post-mortem evaluation after mid-term follow-up. Eur Heart J 35: 1651 | Case report N=1 patient with severe functional TR after multiple preceding open heart procedures, a self-expanding valve was implanted into the IVC at the cavoatrial junction to reduce regurgitant backflow | Successfully deployed and a marked reduction of caval pressure and an abolition of backflow to the IVC was noted. The patient was discharged home and had an improvement of physical capacity and symptoms of right heart failure within the 3-month follow-up period. | Large studies with longer follow up included in evidence summary |
Lauten A, Dreger H, Laule M et al. (2022) Caval valve implantation. Intervent Cardiol Clin 11: 95–102 | Review on current evidence for CAVI and potential role for treatment of TR | CAVI was applied successfully for compassionate treatment in human patients. Haemodynamic improvement has been consistently seen; the clinical benefit of the procedure still needs further evaluation. It remains to be determined which patients benefit most from this approach and which outcome measures are most suitable. | Review |
Laule M, Stangl V, Sanad W et al. (2013) Percutaneous transfemoral management of severe secondary tricuspid regurgitation with Edwards Sapien XT bioprosthesis: first-in-man experience. J Am Coll Cardiol 61: 1929–31 | Case series N=3 patients with severe functional TR had treatment with IVC caval implantation (balloon-expandable valves Edwards Sapien XT valve) | Large studies with longer follow up included in evidence summary | |
O'Neill BP, Wheatley G, Bashir R et al. (2016) Study design and rationale of the heterotopic implantation of the Edwards Sapien XT transcatheter valve in the inferior vena cava for the treatment of severe tricuspid regurgitation (HOVER) Trial. Catheterization and Cardiovascular Interventions 88: 287–93 | Prospective non-randomised study. Heterotopic implantation of the Sapien XT valve in the IVC for the treatment of severe TR in patients who are at high risk or cannot be operated on | A total of 30 patients will be enrolled. The primary objective of the study will be to show procedural success at 30-days and patient success at 1-year. | Study design and rationale |
Romaguera R, Roura G, Ruiz-Majoral A et al. (2021) First bicaval valve implantation in a heart transplant patient to treat severe symptomatic tricuspid regurgitation. Circulation: Heart Failure 14,1278–9 | Case report N=1 patient (67-year-old) with severe TR and RV dysfunction had a bicaval valve (TricValve) implantation | At 6-months follow up, functional status improved to NYHA class II, and the diuretic treatment was tapered without heart failure recurrence. Similar RV dysfunction and absence of systolic reverse flow to cava veins noted. | Large studies with longer follow up included in evidence summary |
Sharkey A, Munoz Acuna R, Belani K et al. (2020) Heterotopic caval valve implantation for the management of severe tricuspid regurgitation: a case series. Eur Heart J Case Rep; 5: ytaa428 | Case report N=2 patients with severe TR with symptoms of heart failure refractory to medical therapy had heterotopic CAVI with Edwards SAPIEN 3 valve | Valve was implanted in the IVC/right atrium junction. In both patients, there was improvement in the postoperative haemodynamics as measured by invasive and non-invasive methods. Successful discharge was achieved in both patients with improvement in their symptoms. | Large studies with longer follow up included in evidence summary |
Sharma NK, Chouhan NS, Bansal M et al. (2021) Heterotopic caval valve implantation in severe tricuspid regurgitation. Ann Card Anaesth 2021 Jul-Sep;24(3):365–8 | Case report N=1 patient with previous mitral valve surgery with chronic severe TR who had CAVI with self‑expandable TricValve in SVC | The procedure was successful. The procedure resulted in significant haemodynamic and symptomatic improvement at 3-month follow up. | Large studies with longer follow up included in evidence summary |
Toggweiler S, De Boeck B, Brinkert M et al. (2018) First-in-man implantation of the Tricento transcatheter heart valve for the treatment of severe tricuspid regurgitation. EuroIntervention 2018; 14: 758–61 | Case report N=1 patient with severe TR and holosystolic hepatic vein backflow had Tricento transcatheter heart valve implantation via the transvenous transfemoral access | Following successful implantation, caval vein regurgitant volume was reduced leading to symptomatic and clinical improvement at 3-month follow up. | Large studies with longer follow up included in evidence summary |
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