Interventional procedure overview of transcatheter tricuspid valve leaflet repair for tricuspid regurgitation
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Summary of key evidence on transcatheter tricuspid valve leaflet repair for tricuspid regurgitation
Study 1 Montalto C (2020)
Study type | Systematic review and meta-analysis |
|---|---|
Country | Not reported for individual studies (3 were described as international) |
Recruitment period | Search date: September 2019 |
Study population and number | n=454 (7 studies); 362 edge-to-edge leaflet plasty, 47 increased leaflet coaptation surface, 30 annular reduction, 15 bicuspidalisation by pledget-plication |
Age and sex | Mean 76.7 years; 41% (188/454) male |
Patient selection criteria | Studies were eligible if they fulfilled all the following criteria: 1) they included patients with at least moderate tricuspid regurgitation (adjudicated using a semiquantitative method) and who had treatment with transcatheter repair devices; and 2) they reported at least 1 of the primary outcomes of interest at a minimum follow-up point of 30 days. Case reports, letters and studies that did not clearly report the numbers and rates of patients alive at follow up were excluded from the analysis. Studies in which severe tricuspid regurgitation was treated using transcatheter implantation of prosthetic valves were also excluded. |
Technique | Transcatheter tricuspid valve repair. Devices included MitraClip (Abbott Vascular, US; n=334), PASCAL (Edwards Lifesciences; n=28), Cardioband (Edwards Lifesciences, US; n=30), FORMA (Edwards Lifesciences; n=47) and Trialign (Mitralign, US; n=15). |
Follow up | range 30 days to 1 year |
Conflict of interest/source of funding | None for authors of the review. |
Analysis
Follow-up issues: Studies were only included if they had a minimum of 30 days follow up for at least 1 of the primary outcomes of interest.
Study design issues: The review was done in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses and Meta-Analysis of Observational Studies in Epidemiology guidelines. All included studies were interventional, multicentre, single arm, and prospective. The primary endpoints of the analysis were the rate reduction of severe tricuspid regurgitation and NYHA functional class 3 or 4 at longest follow up available. Procedural success definition included at least successful device implantation because of the varying definitions in the studies. Pooled risk ratios and standardised mean differences with 95% CIs were used as summary statistics for outcomes of interest and were calculated using a random-effects model. Heterogeneity was considered to be low when I2 was less than 25%, moderate when I2 was less than 75%, and high when I2 was more than 75%. No publication bias was identified by visually inspecting funnel plots and by mathematical testing.
Study population issues: Of the 454 patients, 45 had a transcatheter tricuspid valve annuloplasty, which is covered by a separate overview.
Patients were at high surgical risk, with a mean EuroSCORE 2 score of 6.8% (95% CI 5.4% to 8.1%). Tricuspid aetiology was mostly functional (90%; 95% CI 82% to 99%), and 90% (95% CI 82% to 100%) of patients were in NYHA functional class 3 or 4.
Studies included the following named trials: TRI-REPAIR, TriValve, TRILUMINATE and SCOUT.
Key efficacy findings
Number of patients analysed: 454
Procedural success: 86% of patients (95% CI 78% to 95%)
All-cause mortality rate (weighted mean follow up 265 days): 9% (95% CI 5% to 16%)
The sensitivity analysis revealed that no study statistically significantly changed the relative risk of being in NYHA functional class 3 or 4 at follow up, as stepwise study omission did not result in a shift of the point estimate out of the 95% CI.
The random-effect subgroup analysis revealed that at follow up, the proportion of patients in NYHA functional class 3 or 4 and of patients with tricuspid regurgitation graded severe or worse were reduced regardless of the device used.
Parameter | Baseline value, incidence or pooled mean (95% CI) | No. of studies | RR or MD | Follow up: RR or MD (95% CI) | p value | I2 (%) | p for hetero-geneity |
|---|---|---|---|---|---|---|---|
Incidence of NYHA class 3 or 4 | 90% (82% to 99%) | 7 | RR | 0.23 (0.16 to 0.33) | 0.004 | 39 | 0.13 |
Mean 6-minute walk distance, metres | 245.4 (215.8 to 275.0) | 6 | MD | 64.6 (41.3 to 87.9) | <0.0001 | 0 | 0.78 |
Mean left ventricular ejection fraction, % | 57 (52.9 to 61.0) | 6 | MD | 1.2 (-0.5 to 2.8) | 0.16 | 0 | 0.99 |
Mean TAPSE, mm | 15.1 (14.3 to 15.9) | 6 | MD | -0.09 (-1.2 to 0.98) | 0.85 | 64 | 0.02 |
Incidence of tricuspid regurgitation severe or greater | 95% (87% to 100%) | 4 | RR | 0.38 (0.2 to 0.7) | 0.004 | 90 | 0.0001 |
Mean EROA, mm | 0.9 (0.7 to 1.0) | 6 | MD | -3.1 (-4.4 to -1.9) | <0.0001 | 54 | 0.06 |
Mean tricuspid valve annular diameter, mm | 44.6 (42.5 to 46.7) | 7 | MD | -3.0 (-4.7 to -1.4) | 0.0004 | 63 | 0.01 |
Mean systolic pulmonary artery pressure, mmHg | 41.7 (38.4 to 45.0) | 4 | MD | -1.6 (-4.9 to 1.7) | 0.33 | 53 | 0.09 |
Key safety findings
No safety outcomes were reported.
Study 2 Schlotter F (2021)
Study type | Non-randomised comparative study (using data from the TriValve registry) |
|---|---|
Country | Europe and North America |
Recruitment period | 2014 to 2020 (TTVI group); 2017 to 2017 (medical therapy group) |
Study population and number | n=850 (288 TTVI, 562 medical therapy alone); 213 matched pairs Patients with severe or worse tricuspid regurgitation |
Age and sex | In unmatched cohort, median age was 78 years in the TTVI group and 76 in the control group (p<0.001). In the matched cohort, median age was 78 years for both. The overall proportion of females was 54% (456/850) in the unmatched cohort and 53% (227/426) in the matched cohort. |
Patient selection criteria | In the TTVI group, all patients were symptomatic with signs of heart failure. Tricuspid regurgitation therapy was indicated in accordance with international guidelines. Heart Team consensus rendered all patients at high or prohibitive surgical risk. Caval valve implantations were excluded from the study. In the medical therapy group, patients with at least severe tricuspid regurgitation (on a 4-grade scale) and with a functional tricuspid regurgitation aetiology were retrospectively identified. Patients were excluded if there was a lack of reported TAPSE, age, EuroSCORE 2, estimated glomerular filtration rate, left ventricular ejection fraction, left ventricular end-diastolic diameter, estimated systolic pulmonary artery pressure, haemodialysis, NYHA class, presence of atrial fibrillation or flutter, NT-proBNP, follow up below 31 days without an event, or non-functional aetiology. |
Technique | Devices used in TTVI group: MitraClip (Abbott Vascular, US), Trialign (Mitralign Inc., US), Cardioband, FORMA, PASCAL (Edwards Lifesciences, US), TriCinch System (4Tech, Ireland), and GATE (NaviGate Cardiac Structures, US). Overall, 54 (32.9%) patients had concomitant mitral procedures for significant left-sided valve disease (MitraClip in all cases). |
Follow up | 1 year |
Conflict of interest/source of funding | There is an extensive list of declared interests, including a number of authors reporting grants, personal fees, consultancy, honoraria or non-financial support from companies including Abbott, Amgen, BMS, Bayer, Boston Scientific, Biotronik, Cardinal Health, Cardiovalve, CardioGrad, 4Tech, CSL Behring, DaiichiSankyo, Edwards Lifesciences, Johnson&Johnson, Medtronic Guerbet, Polares, Sanofi, Terumo, Venus Medtech and NaviGate Cardiac Structures Inc. 1 is also Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. 1 author has several patents issued. 1 author has a patent with and is a consultant for TricValve licensed to TricValve. 1 author is a consultant for Japan Lifeline. |
Analysis
Follow up issues: In the TriValve registry, clinical and echocardiographic baseline and follow up data were prospectively collected. Clinical follow up was done by clinical visits or phone consultation at 30 days, 6 months, 1 year, and annually thereafter. Follow up in the medical therapy group was obtained by contacting the local registration offices.
Study design issues: Propensity-matched comparative study, using data on TTVI from a multicentre international registry (TriValve) and medical therapy data from 2 tertiary care centres. The primary endpoint was defined as the incidence of all-cause mortality within 1 year of follow up in the matched population. Patients in the TTVI cohort were matched with patients who had conservative management using propensity scores. The following variables were used for the calculation of propensity scores: TAPSE, age, EuroSCORE II, estimated glomerular filtration rate, left ventricular ejection fraction, left ventricular end-diastolic diameter, echocardiographically determined systolic pulmonary artery pressure, haemodialysis, NYHA class (binary class 1 and 2 compared with 3 and 4), presence of atrial fibrillation or flutter and NT-proBNP. Based on these propensity scores, patients who had TTVI were matched 1:1 with control patients randomly selected from the control pool of patients defined by the parameters using the nearest neighbour rule of ±0.2 standard deviations. The balance between the groups of patients with TTVI and controls was assessed by standardised differences (defined as the difference in means or proportions divided by the mutual standard deviation). Standardised differences below 0.1 were considered not statistically significant. Patients were stratified according to TAPSE (preserved [more than 17 mm], mid-range [13 to 17 mm] and reduced [less than 13 mm]) right ventricular function.
Study population issues: Patients in the unmatched TTVI cohort had statistically significantly higher age, EuroSCORE 2, higher rates of atrial fibrillation, higher left ventricular ejection fraction, larger left ventricular enddiastolic diameter and lower rates of haemodialysis, TAPSE, lower proportion of mitral regurgitation grade 3 or above and lower systolic pulmonary artery pressure compared with the unmatched conservatively treated cohort (all p<0.05).There were no statistically significant differences between unmatched and matched patients. Most patients (89%) were in NYHA functional classes 3 or 4. Overall, 166 patients had preserved, 179 mid-range reduced and 81 reduced right ventricular function, with no statistically significant difference between TTVI and medical therapy.
Key efficacy findings
Number of patients analysed: 426 (213 TTVI, 213 medical therapy)
Procedural success (defined as a device successfully implanted and delivery system retrieved, with a residual tricuspid regurgitation grade 2 or less)
In the matched TTVI cohort, procedural success was 80.7% (n=167).
Estimated mortality at 1 year in the matched cohort
TTVI=13.1%
Medical therapy=25.4%, p=0.031
In isolated TTVI, the 1-year mortality rate was also statistically significantly lower in the matched TTVI cohort when compared to either conservative treatment or conservative treatment without mitral regurgitation grade 3 or higher (p=0.001 and p=0.006, respectively).
Relationship between outcome and right ventricular dysfunction
In patients with mid-range RV function, TTVI was associated with a survival benefit when compared to medical therapy, but there was no survival benefit in patients with preserved or reduced right ventricular function.
In patients who had TTVI or medical therapy, reduced right ventricular function was associated with impaired outcome (p log-rank 0.032 and 0.020, respectively).
In patients who had TTVI, patients with mid-range right ventricular function improved to the level of patients with preserved RV function.
In patients with mid-range right ventricular function, procedural success, EuroSCORE 2, left ventricular ejection fraction less than 40%, NT-proBNP and estimated glomerular filtration rate were associated with all-cause mortality. However, on multivariable analysis, only procedural success (HR 0.22, 95% CI 0.09 to 0.57) and EuroSCORE 2 (HR 1.10, 95% CI 1.01 to 1.20) remained independent predictors of an adverse outcome in this patient population.
Key safety findings
None reported
Study 3 Taramasso M (2019a)
Study type | Non-randomised comparative study (using data from the TriValve registry) |
|---|---|
Country | Europe and North America |
Recruitment period | 2016 to 2018 (registry data) |
Study population and number | n=1,651 (472 TTVI, 1,179 medical therapy); 268 matched pairs Patients with severe tricuspid regurgitation |
Age and sex | In the unmatched cohort, mean age was 77 years in the TTVI group and 76 in the control group (p=0.07). In the matched cohort, mean ages were 77 and 76 years, respectively (p=0.2). In the unmatched cohort, the proportion of females was 55% in the TTVI group and 63% in the control group (p=0.007). In the matched cohort, the proportion of females was 56% and 59%, respectively (p=0.4). |
Patient selection criteria | The TTVI cohort included patients with severe or greater symptomatic tricuspid regurgitation according to the European or American guidelines. The decision to do the procedure was taken by a local multidisciplinary team after clinical and anatomical assessment. Exclusion criteria in the control group were previous tricuspid valve surgery or intervention and iatrogenic (pacemaker lead-related) tricuspid regurgitation. |
Technique | Devices used in TTVI cohort: MitraClip (Abbott Vascular, US), FORMA (Edwards Lifesciences, US), Cardioband (Edwards Lifesciences), Tri-Cinch (4TECH, Ireland), Trialign (Edwards Lifesciences), caval valve implantation devices), PASCAL (Edwards Lifesciences), and NaviGate (NaviGate Cardiac Structures, US). 63 (23%) patients in the TTVI group had concomitant mitral valve treatment (Mitraclip). All patients in both groups had medical treatment according to guideline-directed medical therapy. |
Follow up | Median 11 months (IQR 4 to 28 months) |
Conflict of interest/source of funding | There is an extensive list of declared interests, including a number of authors reporting grants, personal fees, consultancy, honoraria or non-financial support from companies including Abbott, Amgen, Boston Scientific, 4Tech, CoreMedic, St Jude Medical, Biotronik, Edwards Lifesciences, Medtronic, MitralTech, Neovasc, InnovHeart, Claret Medical, Meril Lifesciences, Admedus, Biosense Webster, Mitralign, Millipede, TricValve, Ablative Solutions, Ancora Heart, Bavaria Medizin Technologie GmbH, Bioventrix, Carag, Cardiac Dimensions, Celonova, Comed BV, Terumo and Vascular Dynamics. One is also Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. One author has equity in Thubrikar Aortic Valve Inc, Dura Biotech, Biotrace Medical, and MID. One author is cofounder of Cardiac Implants and 1 is cofounder of 4Tech and founder of Occlufit, SwissVortex, transseptalsolutions, and Perifect. |
Analysis
Study design issues: Propensity matched retrospective case-control study, using data from the TriValve registry for the TTVI cohort and 2 large tertiary centres for the control cohort. The variables used to calculate propensity score were age, EuroSCORE 2, and pulmonary pressure level. For each case, a control patient was randomly selected from the potential pool of candidates defined by the parameters using the nearest neighbour rule of ±0.2 SD. The primary endpoint was mortality from any cause or rehospitalisation for heart failure. Survival was tested with Cox regression analysis. After TTVI, procedural success was defined as patient alive at the end of the procedure, with device successfully implanted, delivery system retrieved, and residual tricuspid regurgitation less than 3+. Medical regimens in the control cohort were not standardised. No central echocardiography core laboratory adjudication was available because of the type of the study.
Study population issues: Patients in the 2 groups had similar left ventricular ejection fraction and age. The cause of tricuspid regurgitation was mostly functional (91% in TTVI group, 96% in control subjects). The proportion of females was lower in the TTVI group (55% compared with 63% in the control group), and more patients had chronic atrial fibrillation (85% in the TTVI group compared with 57% in the control group). A total of 26% of TTVI compared with 5% of patients in the control group had a previously implanted pacemaker or defibrillator with a lead across the tricuspid valve. Most patients in the TTVI group were severely symptomatic at the time of the procedure (93% were in NYHA functional class 3 or 4). Patients in the TTVI group had lower EuroSCORE 2 (10.5 compared with 17.9), more prevalent right ventricular dysfunction (34% compared with 20%), and lower pulmonary pressure level (40 mmHg compared with 52 mm Hg). Baseline characteristics of the matched subgroup were more balanced between TTVI and control patients. Patients in the TTVI group still had higher NYHA functional class (93% had class 3 to 4 compared with 23% in the control group, p<0.0001) and higher prevalence of atrial fibrillation, right ventricular dysfunction, mitral regurgitation, and implanted pacemaker/defibrillator.
Key efficacy findings
Number of patients analysed: 536 (268 TTVI, 268 medical therapy alone)
Procedural failure with residual tricuspid regurgitation 3+ or above=14.2% (38/268)
A higher proportion of patients with right ventricular dysfunction had a successful procedure (65% compared with 39%, p=0.002).
Mortality at 6 months
TTVI=13.8%
Medical therapy alone=26.1%
Mortality at 1 year
TTVI=22.6%
Medical therapy alone=36.2%, p=0.001
Rehospitalisation for heart failure at 1 year
TTVI=26%
Medical therapy alone=47%, p<0.0001
Composite endpoint
TTVI=32%
Medical therapy alone=49%, p=0.0003
Model for Control Group | Hazard ratio (95% CI) for death or heart failure hospitalisation (primary endpoint) | p value | Hazard ratio (95% CI) for mortality (secondary endpoint) | p value |
|---|---|---|---|---|
Unadjusted | 0.60 (0.46 to 0.79) | 0.003 | 0.56 (0.39 to 0.79) | 0.001 |
Adjusted for sex and NYHA functional class | 0.46 (0.31 to 0.68) | 0.0001 | 0.49 (0.31 to 0.79) | 0.003 |
Adjusted for sex and NYHA functional class, atrial fibrillation, and right ventricular dysfunction | 0.39 (0.26 to 0.59) | <0.0001 | 0.41 (0.26 to 0.67) | 0.0004 |
The beneficial TTVI impact on survival persisted after a more extensive adjustment including mitral regurgitation and pacemaker/defibrillator, hazard ratio 0.35 (95% CI 0.23 to 0.54; p<0.0001).
In multivariable analysis, TTVI remained associated with greater survival free from heart failure rehospitalisation, when concomitant mitral regurgitation treatment (MitraClip), was added to the model (hazard ratio 0.28; 95% CI 0.11 to 0.79; p=0.02 after comprehensive adjustment).
Key safety findings
None reported
Study 4 Taramasso M (2019b)
Study type | Registry (TriValve) |
|---|---|
Country | Switzerland, Germany, France, Italy, US, Canada (18 centres) |
Recruitment period | 2014 to 2018 |
Study population and number | n=312 Patients with severe or greater symptomatic tricuspid regurgitation |
Age and sex | Mean 76 years; 56% female |
Patient selection criteria | All patients included in the registry had severe or greater symptomatic tricuspid regurgitation according to the European or American guidelines for managing heart valve disease and had treatment according to local multidisciplinary team decision. |
Technique | Devices: MitraClip (Abbott Vascular, US), FORMA (Edwards Lifesciences, US), Cardioband (Edwards Lifesciences), TriCinch (4tech, Ireland), Trialign (Mitralign, US), Caval valve implantation, PASCAL (Edwards Lifesciences), and NaviGate (NaviGate Cardiac Structures, US). Most procedures (n=210) used MitraClip. All but 1 procedures were done using general anaesthesia under fluoroscopic and echocardiographic guidance. One case of TriCinch was done under conscious sedation using intracardiac echocardiography. 64% of patients had isolated TTVI. In the remaining patients, TTVI was done concomitantly during transcatheter mitral repair (n=108), transcatheter aortic valve replacement (n=1) or paravalvular leak closure (n=1). |
Follow up | Median 6.2 months (IQR 0.4 to 15.5 months) |
Conflict of interest/source of funding | There is an extensive list of declared interests, including a number of authors reporting grants, fees, consultancy, honoraria or non-financial support from companies including Abbott, Amgen, Boston Scientific, 4Tech, CoreMedic, St Jude Medical, Biotronik, Edwards Lifesciences, Medtronic, MitralTech, Neovasc, InnovHeart, Biosense Webster, Mitralign, Millipede, TricValve, Ablative Solutions, Ancora Heart, Bavaria Medizin Technologie GmbH, Bioventrix, Carag, Cardiac Dimensions, Celonova, Comed BV, Terumo, Vascular Dynamics, NaviGate and GE Healthcare. One author is cofounder of Cardiac Implants and 1 is cofounder of 4Tech. |
Analysis
Follow-up issues: Procedural and periprocedural outcomes were only available for 280 (89.7%) patients (the remaining 32 patients were included in ongoing unpublished trials, so only baseline characteristics were provided at this stage). Modalities of follow up differed between the different centres.
Study design issues: Prospective multicentre registry data. Procedural success was defined as patient alive at the end of the procedure, with the device successfully implanted and delivery system retrieved, with a residual tricuspid regurgitation 2 or less. There was no core lab adjudication.
Study population issues: At baseline, the mean EuroSCORE 2 was 9%. Aetiology of tricuspid regurgitation was functional in 92% (288/312) of patients and mean annular diameter was 46.9 mm; 71 patients (23%) had a previously implanted intracardiac device and presented with a transtricuspid right ventricular lead. Of the 312 patients, 35% had a history of previous left-side valve intervention (84 surgical, 24 percutaneous, 3 both). Prevalence of long-standing atrial fibrillation was 78%, and median NT-proBNP at baseline was 2,759 pg/ml (IQR 1,298 to 5,627 pg/ml). Most of the patients were severely symptomatic and 95% were in NYHA functional class 3 or 4.
Key efficacy findings
Number of patients analysed: 280
Procedural success=72.8% (there were no statistically significant differences between devices)
Reduction of at least 1 degree of tricuspid regurgitation severity=83.9% (235/280)
Overall actuarial survival at 1.5 years=77.2 ± 5.9%
Actuarial survival at follow up was statistically significantly better in patients in whom acute procedural success was achieved (90.8% compared with 70.3% at 1 year, p=0.0002). Superior survival according to procedural success was also seen when only isolated TTVI were considered (69% compared with 89% at 1 year, p=0.0037)
Severity | Proportion of patients at baseline | Proportion of patients at 30 days |
|---|---|---|
1+ | 0% | 26% |
2+ | 2% | 36% |
3+ | 35% | 22% |
4+ | 63% | 16% |
NYHA functional class | Proportion of patients at baseline | Proportion of patients at 30 days | Proportion of patients at 6 months |
|---|---|---|---|
1 | 0% | 8% | 7% |
2 | 4% | 53% | 47% |
3 | 65% | 36% | 37% |
4 | 31% | 3% | 9% |
Variable | Univariate odds ratio (95% CI) | p value | Multivariate odds ratio (95% CI) | p value |
|---|---|---|---|---|
Coaptation depth | 31.8 (4.8 to 244) | 0.0002 | 24.1 (3 to 231) | 0.002 |
Annular diameter | 8.07 (1.1 to 61.8) | 0.03 | 7.2 (0.9 to 1.12) | 0.06 |
Vena contracta | 0.2 (0.1 to 37.9) | 0.12 | - | - |
Presence of pacemaker lead | 0.9 (0.5 to 4.5) | 0.70 | - | - |
MitraClip versus other device | 0.6 (0.5 to 5.8) | 0.11 | - | - |
TAPSE <17 mm | 1.02 (0.2 to 2.9) | 0.90 | - | - |
Left ventricular ejection fraction, % | 0.65 (0.12 to 2.7) | 0.50 | - | - |
systolic pulmonary artery pressure | 8.8 (1.8 to 77) | 0.01 | 0.1 (0.06 to 1.5) | 0.10 |
Key safety findings
Intraprocedural deaths=0%
Major adverse events at 30 days
Overall=10.4% (29/280)
Mortality=3.6% (10 patients: 2 sepsis, 2 respiratory insufficiency, 6 progressive right ventricular failure). It was statistically significantly lower among patients with procedural success (1.9% compared with 6.9%, p=0.04).
Major bleeding=1.7% (5/280)
Stroke=1.1% (3/280)
Acute myocardial infarctions needing right coronary artery stenting=0.7% (2/280)
Conversions to surgery=1.4% (4/280) (in 2 patients, emergency surgery was needed and in the other 2 patients, tricuspid surgery was done electively because of procedural failure)
Respiratory failure= 0.7% (2/280)
Device detachment=0.4% (1/280)
Ventricular arrhythmia=0.4% (1/280)
Aortic prosthetic valve thrombosis=0.4% (1/280)
Study 5 Mehr M (2019)
Study type | Registry (TriValve) |
|---|---|
Country | Europe and North America (14 centres) |
Recruitment period | 2015 to 2018 |
Study population and number | n=249 Patients with symptomatic tricuspid regurgitation |
Age and sex | Mean 77 years; 51% (128/249) female |
Patient selection criteria | All patients included were symptomatic, with signs of right-sided or global heart failure such as peripheral oedema, ascites, pleural effusion, and dyspnoea on exertion. Most patients were in NYHA functional class 3 or 4 and were deemed at high or prohibitive risk for surgery. |
Technique | Devices: MitraClip (Abbott Structural Heart, US). Most procedures used MitraClip NT, but MitraClip XTR was introduced in 2018. The intervention was guided by 2-dimensional and 3-dimensional transthoracic and transoesophageal echocardiography as well as fluoroscopy. Concomitant edge-to-edge repair of the mitral valve was done when indicated (n=129, 52%). |
Follow up | Median 290 days (IQR: 141 to 392 days) |
Conflict of interest/source of funding | There is an extensive list of declared interests, including a number of authors reporting grants, fees, consultancy, honoraria or non-financial support from companies including Bristol-Myers Squibb, Abbott, Boston Scientific, 4tech, CoreMedic, Edwards Lifesciences, Neovasc, Amgen, Biotronik, Medtronic, St. Jude, Terumo, Biosense Webster, Mitralign, Ablative Solutions, Ancora Heart, Bavaria Medizin Technologie GmbH, Bioventrix, Carag, Cardiac Dimensions, Celonova, Comed B.V., Contego, CVRx, Endologix, Hemoteq, Lifetech, Maquet Getinge Group, Nuomao Medtech, Occlutech, pfm Medical, Recor, Renal Guard, Rox Medical, Vascular Dynamics, Vivasure Medical, InnovHeart, Millipede, Cardiovalve, and Valtech. One author is supported by a New Investigator award from the Canadian Institutes of Health Research and an Early Researcher award from the Ontario Ministry of Research. One author is cofounder of Cardiac Implants and 1 is cofounder of 4tech. |
Analysis
Follow up issues: Data on clinical outcomes were available in 83% of eligible patients and echocardiographic follow up was available in 79% of eligible patients.
Study design issues: Prospective multicentre registry data. The main endpoints were all-cause mortality and a composite of all-cause mortality and unplanned rehospitalisation for heart failure within 12 months after the procedure. Technical success was defined as placement of at least 1 clip in the tricuspid valve. Procedural success was defined as a successful implantation of the clip device and a post-procedural tricuspid regurgitation of grade 2+ or less. Defined subgroups of the analysis were edge-to-edge repair in the tricuspid valve only, compared with combined mitral and tricuspid repair as well as successful edge-to-edge repair, compared with procedural failure.
Study population issues: Most patients (94%) were in NYHA functional class 3 or 4 and severely symptomatic. 24% of patients had ascites, 84% peripheral oedema, and 74% had a history of hospital admission for heart failure. The mean EuroSCORE 2 was 6.4% (IQR 3.9% to 13.9%). The mean septolateral diameter of the tricuspid annulus was 47.0 mm, and tricuspid regurgitation was secondary in 90% of patients. The mean tricuspid coaptation gap was 5.3 mm.
This study is also included in the systematic review by Montalto et al. (2020).
Key efficacy findings
Number of patients analysed: 249
Technical success=96%
Procedural success=77%
Tricuspid regurgitation reduction of at least 1 grade after the procedure=89.2% (222/249)
Tricuspid regurgitation reduction of at least 1 grade at last follow up=72%
The proportion of patients with tricuspid regurgitation grade 3 or above reduced from 97% at baseline to 23% before discharge (p<0.001).
Combined endpoint of death or unplanned hospitalisation for heart failure at follow up=31% (76/249)
Estimated mortality at 1 year (Kaplan-Meier)=20.3% (95% CI 14.6% to 25.8%)
Estimated rate of combined mortality and rehospitalisation for heart failure at 1 year (Kaplan-Meier)=34.7% (95% CI 27.7% to 41.0%)
Severity | Proportion of patients at baseline, n=249 | Proportion of patients before discharge, n=249 | Proportion of patients at last follow up, n=167 |
|---|---|---|---|
1+, mild | 0 (0) | 95 (38.1) | 61 (36.5) |
2+, moderate | 8 (3.2) | 97 (39.0) | 60 (35.9) |
3+, severe | 112 (45.0) | 42 (16.9) | 35 (21.0) |
4+, massive | 129 (51.8) | 15 (6.0) | 11 (6.6) |
P<0.001 between baseline and discharge and p=0.89 between last follow up and discharge
NYHA functional class | Proportion of patients at baseline, n=249 | Proportion of patients at last follow up, n=175 |
|---|---|---|
1 or 2 | 11 (4.4) | 121 (69.1) |
3 | 170 (68.3) | 52 (29.7) |
4 | 68 (27.3) | 2 (1.1) |
Variable | Univariate odds ratio (95% CI) | p value | Multivariate odds ratio (95% CI) | p value |
|---|---|---|---|---|
Pacemaker or ICD lead | 1.53 (0.81 to 2.84) | 0.18 | - | - |
Left ventricular ejection fraction, % | 1.00 (0.98 to 1.02) | 0.95 | - | - |
TAPSE | 1.02 (0.95 to 1.10) | 0.55 | - | - |
Mitral regurgitation grade | 1.10 (0.84 to 1.44) | 0.48 | - | - |
Vena contracta | 1.76 (0.87 to 3.53) | 0.11 | - | - |
Coaptation gap >6.5 mm | 6.16 (3.19 to 12.18) | <0.001 | 1.23 (1.10 to 1.38) | <0.001 |
EROA >0.695 cm2 | 4.79 (2.52 to 9.33) | <0.001 | 1.21 (1.09 to 1.35) | <0.001 |
coaptation depth >9.75 mm | 3.17 (1.71 to 6.04) | <0.001 | 1.01 (0.90 to 1.44) | 0.83 |
tenting area >3.15 cm2 | 4.78 (2.49 to 9.30) | <0.001 | 1.18 (1.01 to 1.37) | 0.035 |
Noncentral or nonanteroseptal tricuspid regurgitation jet location | 2.38 (0.98 to 5.52) | 0.047 | 1.21 (1.04 to 1.41) | 0.013 |
Annular diameter | 1.03 (0.99 to 1.08) | 0.098 | 1.00 (0.99 to 1.00) | 0.60 |
Concomitant mitral valve edge-to-edge repair | 0.66 (0.36 to 1.20) | 0.17 | - | - |
Number of clips | 0.81 (0.57 to 1.12) | 0.20 | - | - |
Variable | Univariate odds ratio (95% CI) | p value | Multivariate odds ratio (95% CI) | p value |
|---|---|---|---|---|
Age (years) | 1.02 (0.98 to 1.06) | 0.31 | - | - |
EuroSCORE 2 | 0.99 (0.97 to 1.02) | 0.57 | - | - |
Chronic obstructive pulmonary disease | 0.49 (0.21 to 1.16) | 0.103 | - | - |
Pacemaker/ICD | 1.52 (0.83 to 2.79) | 0.18 | - | - |
Absence of sinus rhythm | 3.85 (1.19 to 12.43) | 0.024 | 4.40 (1.34 to 14.49) | 0.015 |
Decrease of 10 ml/min in estimated glomerular filtration rate | 1.29 (1.07 to 1.55) | 0.007 | 1.25 (1.02 to 1.51) | 0.018 |
NYHA functional class | 2.08 (1.20 to 3.62) | 0.009 | 1.73 (0.96 to 3.13) | 0.069 |
Decrease of 10% in left ventricular ejection fraction | 1.25 (1.02 to 1.52) | 0.028 | 1.20 (0.98 to 1.47) | 0.084 |
TAPSE | 0.97 (0.90 to 1.04) | 0.42 | - | - |
Tricuspid regurgitation grade | 1.16 (0.67 to 2.00) | 0.59 | - | - |
Mitral regurgitation grade | 1.13 (0.86 to 1.50) | 0.39 | - | - |
Concomitant mitral valve edge-to-edge repair | 1.07 (0.59 to 1.94) | 0.83 | - | - |
Procedural failure | 2.43 (1.33 to 4.46) | 0.004 | 2.12 (1.12 to 4.02) | 0.014 |
Key safety findings
Procedural deaths=0%
Adverse events
Mortality during initial hospitalisation=2.8% (7/249)
Cardiovascular mortality=2.4% (6/249)
Conversion to open heart surgery 3 days after procedure=0.4% (1/249)
Ischaemic stroke during hospital stay=0.8% (2/249); both patients had concomitant mitral valve intervention
Bleeding=6.0% (15/249)
Acute kidney injury=3.6% (9/249)
Infection=4.8% (12/249)
Pericardial effusion=0.4% (1/249)
Study 6 Lurz P (2021)
Study type | Single arm study (TRILUMINATE) |
|---|---|
Country | US, France, Germany, Italy, Spain, Switzerland (21 sites) |
Recruitment period | Not reported |
Study population and number | n=85 Patients with moderate or greater tricuspid regurgitation |
Age and sex | Mean 77.8 years; 66% female |
Patient selection criteria | Symptomatic patients at high surgical risk with moderate or greater tricuspid regurgitation (by transthoracic and transoesophageal echocardiography) and no indications for left-sided or pulmonary valve correction were included in this study. Exclusion criteria included: systolic pulmonary artery pressure greater than 60 mmHg, (estimated by echocardiography), previous tricuspid valve procedures or coaptation gaps bigger than 10 mm. |
Technique | Device: TriClip (Abbott, US) |
Follow up | Median 12 months |
Conflict of interest/source of funding | The study was funded by Abbott. There is an extensive list of declared interests, including a number of authors reporting grants, fees, participation in trials, consultancy, honoraria or non-financial support from companies including Abbott, Amgen, Edwards Lifesciences, Medtronic, AGA Medical, AstraZeneca, Bayer, Baylis Medical, Berlin Chemie, Biosensus, Biotronic, Boston Scientific, Bristol Myers Squibb, Boehringer Ingelheim, Cardiovalve, Daiichi-Sankyo, Novartis, Navigate, Philips Healthcare, Siemens Healthcare, Pfizer, Resmed, Sanofi, and St. Jude Medical. Two authors have been employees of Abbott. One author has been Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials for which she has received no direct industry compensation.One author has been an unpaid member of the Corvia Medical Scientific Advisory Group. One author has received research funding from the Deutsche Forschungsgemeinschaft, the Federal Ministry of Education and Research and The European Union. |
Analysis
Follow up issues: At 1 year, data to evaluate severity of tricuspid regurgitation was missing for 22 patients: 7 died, 5 withdrew, 4 missed visits and there was a lack of readable echocardiographic data to make an assessment for 6 patients. In addition, baseline imaging was missing for 1 patient, so there were 62 patients (73%) with paired tricuspid regurgitation severities at baseline and 1 year follow up. Data on major adverse events was not available for 1 patient who withdrew from the study.
Study design issues: Prospective, single-arm, multicentre study. The purpose of this report was to study the 1 year outcomes of the valve repair system, including repair durability, clinical benefit and safety.
Study population issues: the study population was the first 85 patients to have an attempted procedure upon femoral vein puncture. The mean EuroSCORE 2 was 8.7%. Tricuspid regurgitation aetiology included functional (84%), degenerative (12%), and mixed (4%). The most common comorbidities were atrial fibrillation (92%), hypertension (86%), renal disease (46%), diabetes (22%), and prior myocardial infarction (18%); 33% of patients had a prior mitral intervention and 75% were classified as NYHA functional class 3 or 4.
Other issues: data from this trial was included in the systematic review by Montalto et al. (2020).
Key efficacy findings
Number of patients analysed: 85
Sustained tricuspid regurgitation reduction of at least 1 grade at 1 year=87.1% (54/62)
Patients with moderate or less tricuspid regurgitation at 1 year=69.8% (44/63)
In multivariate logistic regression, patients with torrential (odds ratio 10.4, p=0.0007) or massive (odds ratio 4.3, p=0.03) tricuspid regurgitation at baseline were less likely to have moderate or less tricuspid regurgitation at follow up compared with patients who had severe tricuspid regurgitation at baseline.
Among all patients with 1-year follow up (n=70), there was a 40% reduction in hospitalisation rate (from 1.30 to 0.78 events/patient-year 1 year before and 1 year after the procedure respectively; p=0.0030).
Reduction to moderate or less tricuspid regurgitation was associated with reduced mortality and heart failure hospitalisations at 1 year (8.8% compared with 24.5%; hazard ratio 0.31, p=0.041).
Variable | Baseline | 30 days | 1 year | p value (baseline versus 1 year) | p value (30 days versus 1 year) |
|---|---|---|---|---|---|
EROA, cm2 | 0.65 (0.03) | 0.40 (0.03) | 0.32 (0.05) | <0.0001 | 0.1053 |
Regurgitant volume, ml/beat | 52.20 (2.35) | 34.83 (2.92) | 27.68 (3.08) | <0.0001 | 0.0607 |
Regurgitation jet area, cm2 | 14.28 (0.69) | 9.18 (0.64) | 7.55 (0.56) | <0.0001 | 0.0007 |
Vena contracta width, cm | 1.73 (0.07) | 1.00 (0.06) | 0.78 (0.05) | <0.0001 | <0.0001 |
PISA radius, cm | 0.91 (0.03) | 0.68 (0.03) | 0.63 (0.04) | <0.0001 | 0.2092 |
Inferior vena cava diameter, cm | 2.29 (0.06) | 2.20 (0.06) | 2.06 (0.06) | 0.0014 | 0.0216 |
Right ventricular end diastolic dimension, cm | 5.28 (0.07) | 4.93 (0.08) | 4.79 (0.08) | <0.0001 | 0.0319 |
Tricuspid annular diameter S-L, cm | 4.34 (0.06) | 4.08 (0.06) | 4.03 (0.07) | <0.0001 | 0.4640 |
Right atrial volume, ml | 129 (5.84) | 117 (6.03) | 116 (6.55) | 0.0166 | 0.8536 |
Right ventricular fractional area change, % | 36.00 (0.85) | 36.77 (0.74) | 38.19 (0.57) | 0.0057 | 0.0649 |
Right ventricular systolic pressure, mmHg | 42.7 (1.08) | 42.0 (1.49) | 43.9 (2.30) | 0.5727 | 0.4525 |
TAPSE, cm | 1.44 (0.03) | 1.49 (0.03) | 1.59 (0.04) | 0.0002 | 0.0069 |
Right ventricular global longitudinal strain, % | -14.1 (0.64) | -12.9 (0.86) | -14.6 (0.86) | 0.5897 | 0.1083 |
Severity | Proportion of patients at baseline, n=62 | Proportion of patients at 1 year, n=62 | Proportion of patients at 30 days, n=63 | Proportion of patients at 1 year, n=63 |
|---|---|---|---|---|
None | 0% | 5% | 5% | 5% |
Mild | 0% | 32% | 30% | 32% |
Moderate | 8% | 34% | 25% | 33% |
Severe | 29% | 19% | 25% | 21% |
Massive | 26% | 6% | 10% | 6% |
Torrential | 37% | 3% | 5% | 3% |
p<0.0001 for comparison between baseline and 1 year; p=0.96 for comparison between 30 days and 1 year
NYHA functional class | Proportion of patients at baseline, n=65 | Proportion of patients at 1 year, n=65 | Proportion of patients at 30 days, n=66 | Proportion of patients at 1 year, n=66 |
|---|---|---|---|---|
1 | 0% | 32% | 20% | 33% |
2 | 31% | 51% | 62% | 50% |
3 | 64% | 17% | 18% | 17% |
4 | 5% | 0% | 0% | 0% |
p<0.0001 for comparison between baseline and 1 year; p=0.39 for comparison between 30 days and 1 year
Self-assessed heart failure symptoms measured by KCCQ showed an improvement of 20 points from baseline to 1 year (p <0.0001); 65% (43/66) of patients had improvement of at least 10 points.
KCCQ continued to increase from 30-day to 1-year follow up (6 point improvement; p=0.0290).
The 6-minute walk distance increased from 272 m at baseline to 303 m at 1 year (p=0.0023).
All-cause mortality at 1 year=7.1% (6/84)
Key safety findings
Major adverse events at 1 year
Overall=7.1% (6/84)
Cardiovascular mortality=4.8% (4/84)
Myocardial infarction=1.2% (1/84)
Stroke=1.2% (1/84)
New onset renal failure=1.2% (1/84)
Endocarditis needing surgery or nonelective cardiovascular surgery for a device-related adverse event=0%
Other clinical safety endpoints
Major bleeding=11.9% (10/84)
Pulmonary thromboembolism=0%
New onset liver failure=0%
New onset atrial fibrillation=1.2% (1/84)
Single leaflet device attachment=7.7% (5/65); no additional intervention was needed and there was no worsening of clinical symptoms.
Embolisation=0%
Mean tricuspid gradient 5 mmHg or above=6.3% (4/64)
Study 7 Asmarats L (2019)
Study type | Case series |
|---|---|
Country | Canada and Europe (4 centres) |
Recruitment period | 2015 to 2016 |
Study population and number | n=19 Patients with severely symptomatic functional tricuspid regurgitation |
Age and sex | Mean 76 years; 74% female |
Patient selection criteria | Patients had severely symptomatic functional tricuspid regurgitation and were deemed to be high or extreme risk for open-heart surgery based on local multidisciplinary heart team assessment. Patients with primary tricuspid regurgitation, prior tricuspid valve surgery, severe concomitant valve disease, or severe left ventricular dysfunction were excluded. |
Technique | Device: FORMA Transcatheter Tricuspid Valve Repair system (Edwards Lifesciences, US); a coaptation transcatheter tricuspid valve repair device designed to increase the leaflet coaptation surface by occupying the regurgitant orifice area. Spacer size was either 15 mm (n=17) or 12 mm (n=1), determined by the largest vena contracta width. |
Follow up | Median 32 months (IQR 24 to 36 months) |
Conflict of interest/source of funding | There is an extensive list of declared interests, including a number of authors reporting grants, fees, participation in trials, consultancy, honoraria or non-financial support from companies including Edwards Lifesciences, Abbott, Amgen, Medtronic, Circle Cardiovascular Imaging, Neovasc, Gore,Tendyne Holdings, Bayer, Bristol-Myers Squibb, Boston Scientific, Biotronik, CSL Behring, Polares, Sinomed, and Heartflow. One author owns stock options in Circle Cardiovascular Imaging and Heartflow. The first author has been supported by a grant from the Fundación Alfonso Martin Escudero and another holds the Research Chair "Fondation Famille Jacques Larivière" for the Development of Structural Heart Disease Interventions. |
Analysis
Follow up issues: Data were collected at baseline, 30 days, and 1 year, and yearly thereafter. Clinical follow up was available for all patients who had successful treatment.
Study design issues: The aim of the study was to evaluate long-term outcomes (2 years or more). Procedural success was defined as successful device implantation in the absence of major device- or procedure-related serious adverse events.
Study population issues: At baseline, the mean EuroSCORE 2 was 9.2%. Of the 19 patients, 18 were in NYHA functional class 3 or above.
Other issues: An earlier report from the same study is included in the systematic review by Montalto et al. (2020).
Key efficacy findings
Number of patients analysed: 19
Procedural success=89.5% (17/19); there was 1 right ventricular perforation needing conversion to open heart and 1 early device dislocation into the right atrium in a patient with severe right-sided chamber enlargement and trabeculation preventing proper anchoring, which was managed conservatively.
All-cause mortality=23.5% (4/17)
Cardiac mortality=17.6% (3/17)
Rehospitalisation for heart failure=17.6% (3/17) during follow up, compared with 58% in the year before the procedure.
The rate of severe tricuspid regurgitation reduced from 95% at baseline to 33% at final follow up (p<0.001).
Mean vena contracta width reduced from 11.8 to 8.4 mm at final follow up (p=0.005).
The proportion of patients in NYHA functional class 3 or 4 reduced from 93% at baseline to 34% at follow up (n=15, p<0.001).
Mean increase in 6-minute walk test distance at follow up=54 m (n=10, p=0.016)
Improvement in KCCQ heart failure score at follow up=16 points (n=9, p=0.016)
There was a statistically significant reduction in peripheral edema (p=0.002), without statistically significant changes in N-terminal pro–B-type natriuretic peptide, renal function, or diuretic dose over time.
Key safety findings
Procedural mortality=0%
Outcomes at 30 days
All-cause mortality=0% (0/19)
Stroke=0% (0/19)
Transient ischaemic attack=5.3% (1/19)
Myocardial infarction=0% (0/19)
Major or life-threatening bleeding=10.5% (2/19); 1 cardiac tamponade in the patient who had surgical conversion and 1 pocket haematoma causing nerve compression.
Acute kidney injury=0% (0/19)
New pacemaker=0% (0/19)
Rehospitalisation for heart failure=0% (0/19)
Late clinical outcomes
Thrombus on device=5.9% (1/17)
Endocarditis=0% (0/17)
Pulmonary embolism=5.9% (1/17)
Ventricular arrhythmia=0% (0/17)
Study 8 Cai S (2020)
Study type | Non-randomised comparative study |
|---|---|
Country | Canada |
Recruitment period | 2015 to 2019 |
Study population and number | n=124 (53 TTVI, 71 medical therapy alone) Patients with severe symptomatic tricuspid regurgitation |
Age and sex | TTVI: mean age 74.8 years; 59% female Medical therapy alone: mean age 77.2 years; 42% female |
Patient selection criteria | Patients on maximally tolerated guideline directed medical therapy were referred for consideration of TTVI to treat symptomatic severe tricuspid regurgitation. Patients who had mild or moderate tricuspid regurgitation, needed open surgical intervention for tricuspid regurgitation, or died before initial consultation were excluded. Eligibility for TTVI was determined based on clinical and anatomical characteristics and by Heart team consensus. The main reason for ineligibility of TTVI was anatomical unsuitability such as a large coaptation gap (more than 10 mm), severe tethering of tricuspid valve leaflets, or lack of clear visualisation of the tricuspid valve on echocardiogram. 26% of patients in the medical therapy group improved with optimisation of medical therapy alone and did not need intervention. |
Technique | Device: MitraClip NT system; median number of clips=2 All patients had guideline directed medical therapy. |
Follow up | TTVI: median 14 months (IQR 7 to 25 months) Medical therapy alone: median 17 months (IQR 9.5 to 23 months), p=0.45 |
Conflict of interest/source of funding | The study was funded by the St Michael's Foundation. One of the authors received a Merit Award from the University of Toronto. Two authors received speaker honoraria from Abbott Vascular and 1 is also a consultant for Edward Lifesciences. |
Analysis
Follow up issues: Follow up data regarding hospitalisation, adverse events, death, laboratory results and medication changes were obtained from patient records by 3 independent reviewers. Follow-up period started from time of initial consultation or time of TTVI and concluded with death or end of study. Patients who had medical therapy alone had routine follow up at time intervals determined by their treating cardiologists. Patients who had TTVI had follow up at 1 month after the procedure, then routine follow up.
Study design issues: Retrospective, single-centre non-randomised comparative study. The study was done in a centre with an experienced, high volume multi-disciplinary valve team specialising in advanced heart failure, cardiac imaging and interventions. The aim was to identify the clinical characteristics and examine outcomes in patients who had TTVI and medical therapy compared with medical therapy alone, using a real world, all-comers approach.
Study population issues: The predominant aetiology of tricuspid regurgitation was functional in both groups, although the medical therapy alone group had a higher prevalence of rheumatic (12.7% compared with 1.9%, p=0.013) and device-lead induced tricuspid regurgitation (18.3% compared with 0%, p=0.013). At baseline, there were no statistically significant differences in age, sex and body mass index between the 2 groups. Compared with the TTVI group, the medical therapy alone group had a trend towards lower clinical risk score for mortality (5.0, IQR 4.0 to 6.0 compared with 6.0, IQR 5.0 to 7.0, p=0.08) and morbidity (5.0, IQR 4.0 to 6.5 compared with 6.0, IQR 5.0 to 7.0, p=0.02). Both groups had a median predicted perioperative mortality of 9% or higher and a median perioperative morbidity of 29% or higher, equating to high surgical risk and were not suitable for open tricuspid valve surgery. A higher proportion of patients in the medical therapy alone group were in NYHA class 1 or 2 compared to the TTVI group (32.4% compared with 6.2%, p=0.023). There was no statistically significant difference in the mean 6‑minute walk test distances at baseline (240.7 m compared with 279.0 m, p=0.52). There was a statistically significantly lower prevalence of chronic kidney disease (19.7% compared with 37.8%, p=0.04), higher baseline eGFR (54.1 ml/min/1.73 m2 compared with 44.5 ml/min/1.73m2, p=0.02), and lower NT-proBNP levels (939.6 pg/litre compared with 3,598.0 pg/litre, p=0.006) in the medical therapy alone group compared with the TTVI group. There was a statistically significantly higher prevalence of concurrent moderate-severe or severe mitral regurgitation in the TTVI group compared with the medical therapy alone group (50.0% compared with 18.8%, p<0.01).
Key efficacy findings
Number of patients analysed: 124
Procedural success (tricuspid regurgitation moderate or less)=77.3%
Overall survival at follow up
TTVI=75.1%
Medical therapy alone=46.9%, p=0.047
Freedom from hospitalisation for heart failure
TTVI=61.7%
Medical therapy alone=43.6%, p=0.074
Freedom from hospitalisation for heart failure and all-cause mortality
TTVI=62.7%%
Medical therapy alone=33.2%, p=0.027
Outcome | Before TTVI, n=53 | After TTVI, n=53 | p value |
|---|---|---|---|
Tricuspid regurgitation severity, n (%) | <0.001 | ||
severe and above | 53 (100) | 12 (22.6) | - |
moderate | 0 (0) | 20 (37.7) | - |
mild | 0 (0) | 21 (39.6) | - |
trace | 0 (0) | 0 (0) | - |
NYHA functional class, n (%) | <0.001 | ||
4 | 5 (10.9) | 3 (5.7) | - |
3 | 38 (82.6) | 4 (7.5) | - |
2 | 3 (6.5) | 38 (71.7) | - |
1 | 0 (0) | 8 (15.1) | - |
Mean 6-minute walk test distance, metres (SD) | 240.7 (138.5) | 334.4 (141.5) | 0.01 |
Mean total daily loop diuretics dose, mg (SD) | 100.8 (91.7) | 107.7 (90.6) | 0.60 |
Mean total daily mineralocorticoid receptor antagonist dose, mg (SD) | 17.4 (21.7) | 19.5 (18.8) | 0.16 |
Key safety findings
There were no periprocedural complications such as tamponade, stroke, death or myocardial infarction.
There were no patients with worsening tricuspid regurgitation or clinically significant tricuspid stenosis after the procedure.
Out of 96 clips deployed in 53 patients, there was 1 single leaflet device attachment which was treated with an additional clip.
Complication | TTVI, n=53 | Medical therapy alone, n=71 | p value |
|---|---|---|---|
Gastrointestinal bleed | 4.2 (0.8 to 12.4) | 15.6 (8.9 to 25.3) | 0.04 |
Stroke | 0 | 2.9 (0.6 to 8.5) | 0.41 |
Myocardial infarction | 0 | 1.0 (0 to 5.4) | 1.00 |
Acute kidney injury | 14.1 (6.8 to 26.0) | 37.0 (26.2 to 50.8) | 0.006 |
New initiation of renal replacement therapy | 4.2 (0.8 to 12.4) | 3.9 (1.1 to 10.0) | 1.00 |
Study 9 Miura M (2019)
Study type | Case report |
|---|---|
Country | Switzerland |
Recruitment period | Not reported |
Study population and number | n=1 Patient with severe tricuspid regurgitation |
Age and sex | 79 year old female |
Patient selection criteria | Not applicable |
Technique | Device: MitraClip XTR system (Abbott Vascular, US). A transfemoral approach was used. |
Follow up | Not reported |
Conflict of interest/source of funding | Not reported |
Analysis
Case report of clip being stuck and knotted because of the Chiari network
At baseline, the patient was in NYHA class 3. She had severe tricuspid regurgitation with annular dilatation, coaptation loss, and pulmonary artery hypertension. A percutaneous edge-to-edge repair of the tricuspid valve was done. The trajectory of the clip was not adequate to grasp the anterior and septal leaflets, and it was pulled back to the right atrium. However, the clip was stuck and trapped by the Chiari network and it was impossible to control. An unsuccessful attempt was made to cross the wire in the gap between the clip's arms and to pull it back using a peripheral balloon. Finally, a clip was deployed and fixed in the inferior vena cava. Another clip was implanted in the anterior and septal leaflets, and 1 was implanted in the posterior and septal leaflets. After deploying the clips, tricuspid regurgitation was reduced.
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