Interventional procedure overview of transcatheter tricuspid valve annuloplasty for tricuspid regurgitation

Technical success

In the single-arm study of 61 people, the device was successfully deployed and the delivery system successfully retrieved as intended in 97% (58/60) of devices. The procedure was abandoned in 1 person because the right coronary artery was perforated by the guidewire before the device was inserted. Procedural success (defined as device success with 30% tricuspid regurgitation reduction in PISA EROA relative to baseline, and without the need for intervention before discharge) was 84% (26/31) and clinical success (procedural success with no major adverse events at 30 days) was 54% (20/37) (Nickenig, 2021).

In the case series of 60 people, technical success (defined as successful delivery, deployment and positioning of device, absence of procedural mortality, and freedom from emergency surgery related to the device) was 97% (58/60) and procedural success (defined as technical success and tricuspid regurgitation reduction of 2 or more grades at discharge) was 45% (27/60) (Körber, 2021).

In the case series of 30 people, device success was 93% (28/30) (Davidson, 2021).

Tricuspid septolateral annular diameter

In the single-arm study of 61 people, the mean tricuspid septolateral annular diameter decreased from 45.5 mm at baseline to 36.1 mm at 30 days follow up (p<0.001) (Nickenig, 2021). In the single-arm study of 30 people, it decreased from 41.9 mm at baseline to 36.2 mm at discharge (p<0.001), 36.5 mm at 1 year and 35.2 mm at 2 years (Nickenig, 2021b). In the case series of 60 people, septolateral diameter of the tricuspid annulus was reduced by a mean of 10.5 mm after the procedure (Körber, 2021). In the case series of 30 people, the mean end-diastolic tricuspid septolateral annular diameter decreased from 45.2 mm at baseline to 39.5 mm at 30 days follow up (p<0.001) (Davidson, 2021).

Tricuspid regurgitation severity

In a single-arm study of 61 people, there was a statistically significant improvement in tricuspid regurgitation severity at discharge and 30 days follow up (p<0.001 for both). The proportion of people with no or mild regurgitation increased from 0% at baseline to 26% at discharge and 36% at 30 days. The proportion of people with severe, massive or torrential regurgitation reduced from 94% at baseline to 41% at discharge and 31% at 30 days. At discharge, 78% of people had at least 1 grade reduction and 59% had at least 2 grades reduction in tricuspid regurgitation. At 30 days follow up, 85% had at least 1 grade reduction and 59% had at least 2 grades reduction (Nickenig, 2021).

In a single-arm study of 30 people, there was a statistically significant improvement in tricuspid regurgitation severity at discharge (n=22), 1 year (n=16) and 2 years (n=11) follow up (p<0.001, p<0.007 and p<0.016 respectively). The proportion of people with mild regurgitation increased from 4% at baseline to 14% at discharge, 13% at 1 year and 36% at 2 years. The proportion of people with severe, massive or torrential regurgitation reduced from 76% at baseline to 45% at discharge, 37% at 1 year and 27% at 2 years (Nickenig, 2021b).

In a case series of 60 people, there was a statistically significant improvement in tricuspid regurgitation severity at discharge and 30 days follow up (p<0.001 for both). The proportion of people with severe, massive or torrential regurgitation reduced from 100% at baseline to 39% at discharge and 33% at 30 days (Körber, 2021). In a case series of 30 people, the proportion of people with mild tricuspid regurgitation increased from 0% at baseline to 15% at 30 days follow up. The proportion of people with severe, massive or torrential regurgitation decreased from 100% to 55%. At 30 days, 85% of people had at least 1 grade reduction and 56% of people had at least a 2 grades reduction in tricuspid regurgitation (Davidson, 2021).

NYHA functional class

In the single-arm study of 61 people, the proportion of people with NYHA functional class 1 or 2 increased from 15% at baseline to 74% at 30 days follow up (p<0.001) (Nickenig, 2021). In the single-arm study of 30 people, the proportion of people with NYHA functional class 1 or 2 increased from 17% at baseline to 78% at 1‑year follow up (p<0.001) and 82% at 2 years (p=0.002) (Nickenig, 2021b). In the case series of 60 people, the proportion of people with NYHA functional class 1 or 2 increased from 21% at baseline to 81% at 30 days follow up (p<0.001) (Körber, 2021). In the case series of 30 people, the proportion of people with NYHA functional class 1 or 2 increased from 32% at baseline to 75% at 30 days follow up (p<0.001) (Davidson, 2021).

6-minute walk test

In the single-arm study of 30 people, the mean 6-minute walk test distance increased from 248 metres at baseline to 296 metres at 1‑year follow up (p<0.053) and 309 metres at 2 years (p=0.058) (Nickenig, 2021). In the case series of 30 people, the mean distance was similar at baseline (245.8 metres) and at 30 days (247.0 metres, p=0.926) (Davidson, 2021).

Quality of life

In the single-arm study of 61 people, the mean overall Kansas City Cardiomyopathy Questionnaire score improved from 50 at baseline to 69 at 30 days follow up (p<0.001). The EQ‑5D‑5L score improved but the difference was not statistically significant (60 at baseline compared with 44 at 30 days follow up, p=0.313) (Nickenig, 2021).

In the single-arm study of 30 people, the mean overall Kansas City Cardiomyopathy Questionnaire score improved from 45 at baseline to 64 at 1 year (p<0.001) and 63 at 2 years follow up (p=0.046) (Nickenig, 2021b). In the case series of 30 people, the mean Kansas City Cardiomyopathy Questionnaire score improved from 53 at baseline to 69 at 30 days follow up (Davidson, 2021).