Interventional procedure overview of transcatheter tricuspid valve leaflet repair for tricuspid regurgitation

Efficacy summary

Technical or procedural success

In a non-randomised comparative study of 213 matched pairs of patients who had TTVI or medical therapy alone, procedural successwas 81%. Procedural success was defined as the device successfully implanted and the delivery system retrieved, with a residual tricuspid regurgitation of grade 2 or less (Schlotter, 2021).

In a non-randomised comparative study of 268 matched pairs of patients who had TTVI or medical therapy alone, procedural failure with residual tricuspid regurgitation of grade 3+ or above was 14% (38/268; Taramasso, 2019a).

In a registry of 312 patients, procedural success was 73% and there was no statistically significant difference between different devices. Procedural success was defined as the patient being alive at the end of the procedure, with the device successfully implanted and the delivery system retrieved, with a residual tricuspid regurgitation of grade 2 or less (Taramasso, 2019b).

In a registry of 249 patients, technical success was 96% and procedural success was 77%. 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 (Mehr, 2019).

In a case series of 19 patients, procedural success was 90% (17/19). Procedural success was defined as successful device implantation in the absence of major device- or procedure-related serious adverse events (Asmarats, 2019).

Tricuspid septolateral annular diameter

In a systematic review of 454 patients (7 studies) who had transcatheter tricuspid valve leaflet repair or transcatheter tricuspid annuloplasty, the mean tricuspid valve annular diameter was statistically significantly reduced at follow up (MD -3.0 mm, 95% CI -4.7 to -1.4, p=0.0004, 7 studies, I²=63%; Montalto, 2020). 

In a single-arm study of 85 patients, the tricuspid annular diameter decreased from 4.34 cm at baseline to 4.03 cm at 1 year (p<0.0001; Lurz, 2021).

Tricuspid regurgitation severity

In the systematic review of 454 patients, the incidence of severe or greater tricuspid regurgitation was statistically significantly reduced at follow up (RR 0.38, 95% CI 0.2 to 0.7, p=0.004, 4 studies, I²=90%; Montalto, 2020).

In the registry of 312 patients, 84% (235/280) of patients had a reduction of at least 1 degree of tricuspid regurgitation severity. The proportion of patients with tricuspid regurgitation severity 3 or 4 reduced from 98% at baseline to 38% at 30‑day follow up (p<0.0001; Taramasso, 2019b).

In the registry of 249 patients, 89% (222/249) of patients had at least 1 grade reduction in tricuspid regurgitation after the procedure and 72% at least 1 grade reduction at last follow up (median 290 days). The proportion of patients with tricuspid regurgitation grade 3 or above reduced from 97% at baseline to 23% before discharge (p<0.001; Mehr, 2019).

In a non-randomised study of 124 patients who had TTVI or medical therapy alone, 77% (41/53) of patients who had TTVI had moderate or less tricuspid regurgitation and 23% (12/53) had severe or above tricuspid regurgitation after the procedure compared with 100% at baseline (53/53; p<0.001; Cai, 2020).

In the single-arm study of 85 patients, 87% (54/62) of patients had sustained tricuspid regurgitation reduction of at least 1 grade at 1-year follow up. Of the 63 patients with data at 1-year follow up, 44 (70%) had moderate or less tricuspid regurgitation compared with 8% at baseline (p<0.0001; Lurz, 2021).

In the case series of 19 patients, the rate of severe tricuspid regurgitation reduced from 95% at baseline to 33% at final follow up (median 32 months, p<0.001; Asmarats, 2019).

NYHA functional class

In the systematic review of 454 patients, the incidence of NYHA class 3 or 4 was statistically significantly reduced at follow up (RR 0.23, 95% CI 0.16 to 0.33, p=0.004, 7 studies, I²=39%; Montalto, 2020).

In the non-randomised study of 124 patients who had TTVI or medical therapy alone, the proportion of patients in NYHA functional class 3 or 4 in the TTVI group reduced from 94% at baseline to 13% at follow up (median 14 months, p<0.001; Cai, 2020).

In the registry of 312 patients, the proportion of patients in NYHA functional class 3 or 4 reduced from 96% at baseline to 39% at 30-day follow up and 46% at 6‑month follow up (p=0.04; Taramasso, 2019b).

In the registry of 249 patients, the proportion of patients in NYHA functional class 3 or 4 reduced from 96% at baseline to 31% at last follow up (median 290 days, p<0.001; Mehr, 2019).

In the single-arm study of 85 patients, the proportion of patients in NYHA functional class 3 or 4 reduced from 69% at baseline to 17% at last follow up (p<0.0001; Lurz, 2021).

In the case series of 19 patients, the proportion of patients in NYHA functional class 3 or 4 reduced from 93% at baseline to 34% at a median follow up of 32 months (n=15, p<0.001; Asmarats, 2019).

Quality of life

In the single-arm study of 85 patients, self-assessed heart failure symptoms measured by KCCQ showed an improvement of 20 points from baseline to 1 year (p <0.0001). There was an improvement of at least 10 points in 65% (43/66) of patients. The KCCQ score continued to improve from 30-day to 1-year follow up (6 point improvement, p=0.0290; Lurz, 2021).

In the case series of 19 patients, the KCCQ heart failure score improved by 16 points at a median follow up of 32 months (n=9, p=0.016; Asmarats, 2019).

6-minute walk test

In the systematic review of 454 patients, the mean 6-minute walk test distance statistically significantly increased at follow up (MD 64.6 m, 95% CI 41.3 to 87.9, p<0.0001, 6 studies, I²=0%; Montalto, 2020).

In the non-randomised study of 124 patients, the mean 6-minute walk test distance statistically significantly increased in the TTVI group from 240.7 m at baseline to 334.4 m at follow up (median 14 months, p=0.01; Cai, 2020).

In the single-arm study of 85 patients, the 6-minute walk distance increased from 272 m at baseline to 303 m at 1 year (p=0.0023; Lurz, 2021).

Survival

In the non-randomised comparative study of 213 matched pairs of patients, estimated mortality at 1 year was 13% in the TTVI group and 25% in the medical therapy alone group (p=0.031; Schlotter, 2021).

In the non-randomised comparative study of 268 matched pairs of patients, mortality at 6 months was 14% in the TTVI group and 26% in the medical therapy alone group, and at 1 year it was 23% compared with 36% (p=0.001;Taramasso, 2019a).

In the non-randomised study of 124 patients, overall survival was 75% in the TTVI group (median follow up 14 months) and 47% in the medical therapy alone group (p=0.047; Cai, 2020).

In the registry of 312 patients, overall actuarial survival at 1.5 years was 77%. Actuarial survival at follow up was statistically significantly better in patients who had a successful procedure (91% compared with 70% at 1 year, p=0.0002; Taramasso, 2019b).

In the registry of 249 patients, estimated mortality at 1 year was 20% (95% CI 15 to 26%). Procedural failure was a predictor of 1 year mortality (multivariate odds ratio 2.12, 95% CI 1.12 to 4.02, p=0.014; Mehr, 2019).

In the single-arm study of 85 patients, all-cause mortality was 7% (6/84) at 1 year (Lurz, 2021).

In the case series of 19 patients with a median follow up of 32 months, all-cause mortality was 24% (4/17) and cardiac mortality was 18% (3/17; Asmarats, 2019).

Rehospitalisation for heart failure

In the non-randomised comparative study of 268 matched pairs of patients, rehospitalisation for heart failure at 1 year was 26% in the TTVI group and 47% in the medical therapy alone group (p<0.0001; Taramasso, 2019).

In the non-randomised study of 124 patients, freedom from hospitalisation for heart failure was 62% in the TTVI group (median follow up 14 months) and 44% in the medical therapy alone group (p=0.074; Cai, 2020).

In the single-arm study of 85 patients, there was a 40% reduction in hospitalisation rate (from 1.30 events/patient-year 1 year before to 0.78 events/patient-year 1 year after the procedure, p=0.0030; Lurz, 2021).

In the case series of 19 patients with a median follow up of 32 months, the rate hospitalisation for heart failure was 18% (3/17) during follow up compared with 58% in the year before the procedure (Asmarats, 2019).