Interventional procedure overview of caval valve implantation for tricuspid regurgitation
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Evidence summary
Population and studies description
This overview is based on 133 patients from 1 RCT, 2 registries, 2 non-randomised studies, 1 observational study and 1 case report. Of these 135 patients, 121 patients had the CAVI procedure and the remaining 14 patients had OMT. This is a rapid review of the literature, and a flow chart of the complete selection process is shown in figure 1. This overview presents 7 studies as the key evidence in table 2 and table 3, and lists 18 other relevant studies in table 5.
The countries where the procedures were carried out include Germany, Canada, Spain, Austria and the United States. The population is comprised of patients 18 years and over with severe TR. The study designs include RCTs, registries, and non-randomised studies. The follow-up periods ranged from 6 months to 12 months. Table 2 presents study details.
Study no. | First author, date country | Patients (male: female) | Age | Study design | Inclusion criteria | Intervention | Follow up | Comments |
|---|---|---|---|---|---|---|---|---|
1 | Dreger H, 2022 Germany | N=28 patients with advanced heart failure CAVI group n=14 (2:12) OMT group n=14 (7:7) | CAVI mean age [IQR]: 77 [72.2-79.5] OMT mean age [IQR]: 77 [68.2-82.0] years | RCT TRICAVAL trial NCT02387697 | NYHA Class ≥2 despite OMT, age ≥50 years, and high surgical risk (logistic EuroSCORE I ≥15% or other contraindications for conventional valve surgery according to the local heart team) | CAVI versus OMT Implantation of a balloon-expandable transcatheter valve (Edwards Sapien XT valve) into the IVC | 12 months | The study was stopped early because of major complications related to valve dislocation and stent migration |
2 | Hewing B, 2021 Germany | N=18 patients with advanced heart failure CAVI group n=8 at completed 3-month follow up) (2:6)OMT group n=10 at completed 3-month follow up) (5:5) | CAVI mean age [IQR]: 79 (68.3-82.6) years OMT mean age [IQR]: 78 (73.3-83.9) years | Non-randomised study Subgroup analysis of RCT TRICAVAL trial NCT02387697 | Severe secondary TR, NYHA class ≥ 2, optimal medical treatment and high surgical risk | CAVI versus medical therapy Implantation of a balloon-expandable transcatheter valve (Edwards Sapien XT Valve) into the IVC | 12 months | The study evaluated the effects of CAVI on clinical signs of congestion, renal and hepatic function. Following major complications, the study was stopped prematurely resulting in a small study sample size for the present subanalysis |
3 | Lauten A, 2018 Germany and Canada (multicentre) | N=25 patients and 31 caval valves implanted (12:13) | Mean age: 73.9 years mean STS score of 14.0 ± 12.7 | Multicentre observational study | Patients presenting with symptomatic severe TR despite OMT and considered unsuitable for surgery | Ballon-expandable (Sapien XT) or self- expanding valves (TricValve) (CAVI) Single valve implantation (76%, 19/25) Bicaval valve implantation (24%, 6/25) Balloon-expandable valves (Sapien XT or Sapien 3: 78.3%,17/31) Self-expandable valves (TricValve: 21.7%, 7/31; Directflow valve: 4%, 1/31) | 12 months | |
4 | Estévez-Loureiro R, 2022 Spain and Austria (12 centres) | N=35 patients with right heart failure had 70 valves implanted (6:29) | Mean age: 76 years | Non-randomised study (TRICUS EURO study) | Adult individuals with symptomatic severe TR (grade ≥3 in a 5-grade classification) despite OMT. Symptoms and signs of right heart failure and NYHA functional class 3 or 4 within 8 weeks before implantation, with echocardiography showing backflow in the IVC and/or SVC and a tricuspid v- wave in the right heart catheterisation ≥ 25 mm Hg | CAVI with TricValve (2 self-expanding valves specifically designed for the SVC and IVC) | 6 months | |
5 | Wild MG, 2022 Switzerland | N=21 high-risk patients (7:14) | Mean age: 76 years | Multicentre registry | Patients with symptomatic severe TR and advanced right heart failure, ineligible for surgery or other transcatheter treatment systems | CAVI with TRICENTO implant that consists of a stent graft that extends from the IVC to the SVC | 12 months | |
6 | O'Neill BP, 2020 United States | N=24 patients had 23 valves implanted (9:15) | Median age: 79.5 years (range, 49-91 years) | Multicentre registry | Patients with symptomatic TR and poor candidates for surgical tricuspid valve intervention as per local heart team discretion | CAVI with implant in IVC only using a single valve (Sapien 3 valve) | 350 days | |
7 | Wilbring M, 2020 Germany | N=2 patients (2:0) | Ages 74 and 83 years | Case report | Patients with symptomatic severe TR | CAVI with Tricento transcatheter heart valve system | 3 months | The radial force of the stent graft seemed to decrease and thus it is not sufficient after 3 months to keep the stent completely open during systole |
Procedure technique
All studies detailed their procedure technique with variations in the intervention implanted. One approach was CAVI with the balloon-expandable Edwards Sapien XT Valve (TRICAVAL) in patients with advanced heart failure (Dreger 2022). Another study used single and bicaval implantations with balloon-expandable (Sapien XT or Sapien 3) and self-expandable (TricValve) valves (Lauten, 2018). The TRICUS EURO study used only the TricValve transcatheter bicaval valves system (Estévez-Loureiro 2022). One study used the TRICENTO system (transcatheter bicaval valved stent graft) (Wild 2022). This device is no longer being manufactured.
Efficacy
NYHA functional class
In an RCT of 28 patients comparing CAVI with OMT in patients with severe TR, compared with baseline, CAVI improved NYHA class after 3 months. But there was no statistically significant difference in NYHA class between the CAVI and OMT groups (−0.3±0.9 compared with −0.6±0.5, p=0.401; Dreger 2022).
In an observational study of 25 patients who had CAVI (31 implanted valves, 13 out of 18 patients had NYHA improvement (p<0.0001). In patients discharged from hospital, CAVI was associated with a symptomatic improvement in 50.2% of patients improving to NYHA class 1 or 2 (Lauten 2018).
In a prospective non-randomised study of 35 patients, patients who had CAVI had statistically significant improvements in NYHA functional class at 6-month follow up compared with baseline (Class 3: 82.9% and class 4: 17.1% at baseline compared with class 1 to 2: 79.4% and class 3: 20.6% at 6-month, p=0.0006; Estévez-Loureiro 2022).
In a multicentre registry of 21 patients who had CAVI with the TRICENTO system, two-thirds of patients remained in NYHA class 1 or 2 at 12-month- follow up (65%, n=13; p<0.001; Wild 2022).
In a multicentre registry of 24 patients who had CAVI with a IVC implant using a single valve, 73% of patients had improvement in at least 1 NYHA class from baseline and 9% were considered worse at follow up compared with baseline (O'Neill 2020).
Quality of life
In the prospective non-randomised study of 35 patients, patients who had CAVI had statistically significant increases in quality of life (assessed using KCCQ12) at 6-month follow up compared with baseline (42.01±22.3 at baseline compared with 59.7±23.6 at 6 month, p=0.0004; Estévez-Loureiro 2022).
In the RCT of 28 patients, compared with baseline, quality of life (assessed using MLHFQ) improved after 3 months in the CAVI group but not statistically significantly (MLHFQ: −19.9±13.1 compared with −7.6±16.3, p=0.098; Dreger 2022).
6MWD
In the RCT of 28 patients, there was no statistically significant difference in the secondary endpoint, the 6MWD, between CAVI and OMT groups (−2.8±71.3 compared with 18.9±47.0, p=0.494; Dreger 2022).
In the prospective non-randomised study of 35 patients, patients who had with CAVI had an increase in 6MWD at 6-month follow up compared with baseline but it was not statistically significant (244.96±85.96 at baseline compared with 276.13±90 at 6 months, p=0.462). But large improvements in 6MWD (>40 m) were evident in 24.1% of patients (Estévez-Loureiro 2022).
Maximal oxygen uptake
In the RCT of 28 patients, maximal oxygen uptake did not change statistically significantly in either group after 3 months, and there was no difference between the OMT and CAVI groups (−0.1±1.8 ml∙kg−1 min−1 compared with −1.0±1.6 ml∙kg−1 min−1, p=0.4995; Dreger 2022).
Dyspnoea
In the RCT of 28 patients, compared with baseline, dyspnoea statistically significantly improved after 3 months in the CAVI group (1.5±1.1 compared with −0.2±1.3, p=0.008; Dreger 2022).
Clinical signs of venous congestion
In an RCT of 18 patients comparing CAVI (n=8) with OMT (n=10) in patients with severe TR, after 12 months, 6 patients in the CAVI group, who completed 12 months of follow up, showed a sustained trend to lower body weight as well as reduced abdominal and leg circumference. But, overall, no statistically significant intra- or intergroup difference about clinical signs of congestion were detected (Hewing 2021).
Renal and hepatic parameters
In a subgroup analysis of the RCT of 18 patients, there was no statistically significant change in levels of laboratory parameters including serum creatinine, cystatin C, urea, serum protein, serum albumin as well as calculated GFR (based on creatinine and cystatin C) between baseline and 3-month follow up within each group. Also, there was no statistically significant difference in these parameters between the groups at 3-month follow up (Hewing 2021).
In the subgroup analysis of the RCT of 18 patients, in the CAVI group, liver function as measured by ALT, AST, gamma-GT and bilirubin remained stable after 3 and 12 months compared with baseline. Also, there was no statistically significant difference in these parameters between the groups at 3- and 12-month follow up (Hewing 2021).
Safety
Complications
Mortality
In the RCT of 28 patients, there was no statistically significant difference in mortality rate between the groups at 12-month follow up (CAVI 57%, n=8 [including 4 after conversion to surgery] compared with OMT 29%, n=4 [from right heart failure, sepsis or haemorrhage], p=0.159; Dreger 2022).
In the observational study of 25 patients,30-day mortality was 12% (3/25). The patients died from progressive multiorgan failure and septic complications (Lauten 2018).
In the multicentre registry of 24 patients, the in-hospital mortality rate (defined as death in the hospital after the procedure) was 21% and the 30-day mortality rate was 25%. Overall mortality occurred in 58% (14/24) patients during a median follow up of 332 days (range, 2-1161 days; O'Neill 2020).
Other major complications
In the RCT of 28 patients, there were2 major complications in the CAVI group within 7 to 48 hours after implantation. These included 2 valve dislocations and 2 stent migrations leading to cardiac tamponades. All patients needed open heart surgery for removal of dislocated valves and migrated stents (Dreger 2020, Hewing 2021). There were 4 heart failure hospitalisations in each of the groups (p=1.00). Sepsis (n=3) and haemorrhage (n=1) were also reported in the CAVI group (Dreger 2020).
In the prospective non-randomised study of 35 patients, major bleeding occurred in 17% of patients. The heart failure hospitalisation readmission rate was 20% (7/35), all of them mainly right heart failure, and mostly related to respiratory infections or renal function deterioration in a population with high comorbidity burden (Estévez-Loureiro 2022).
In the multicentre registry of 21 patients, vascular complications and postprocedural acute kidney injury occurred in 4 cases for each complication (Wild 2022).
In a case report of 2 patients using the TRICENTO transcatheter heart valve system, within the first 3 months, both patients developed recurrent signs of right heart failure despite sufficient function of the ectopic tricuspid valve system. Also, MRI scans of the heart revealed a nearly complete systolic compression of the stent graft at the level of the right atrium in both patients (Wilbring 2020).
Anecdotal and theoretical adverse events
Expert advice was sought from consultants who have been nominated or ratified by their professional society or royal college. They were asked if they knew of any other adverse events for this procedure that they had heard about (anecdotal), which were not reported in the literature. They were also asked if they thought there were other adverse events that might possibly occur, even if they had never happened (theoretical).
They suggested a theoretical adverse event of rhythm disturbance and conversion to open surgery (sternotomy and tricuspid valve repair).
Seven professional expert questionnaires for this procedure were submitted. Find full details of what the professional experts said about the procedure in the specialist advice questionnaires for this procedure.
Validity and generalisability
One small RCT compared CAVI to optimal medical therapy.
Follow up in studies ranged from 6 months to 12 months.
Studies included patients with symptomatic severe TR that was ineligible for surgery.
Studies on CAVI varied in terms of the approach (unicaval and bicaval), number of implants and the type of implant (self-expandable or balloon-expandable) being used.
CAVI with balloon-expandable valves (Edwards Sapien XT or Sapien 3) has been done under compassionate clinical use.
The company producing a dedicated CAVI device currently in clinical use (TRICENTO) are no longer manufacturing this device.
A CE mark study (NCT04289870) is underway for another device (TILLIUM device).
The title of this topic has been amended as 'caval valve implantation for tricuspid regurgitation' to cover both unicaval and bicaval valve implantations.
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