30-Day Outcomes of Transcatheter Tricuspid Annuloplasty With the K-Clip System

Figures

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  Figure 1. Preprocedural TTE and TEE (A) TR vena contracta width is measured from TTE (width, 7.8 mm). (B) PISA estimated Doppler volume method EROA and regurgitant volume are measured from TTE (EROA, 67 mm2; regurgitant volume, 46 mL). (C) The vena contracta area is measured from TTE (area, 79.9 mm2). (D) The septolateral diameter of the tricuspid valve annulus is measured from TTE (diameter, 4.0 cm). (E) The maximum circumference and area of the tricuspid annulus are measured from 3D TEE in diastole (circumference, 16.3 cm; area, 20.8 cm2). (F) The gap shape is shown from 3D TEE in systole (gap area, 3.1 cm2). 3D = 3-dimensional; EROA = effective regurgitant orifice area; PISA = proximal isovelocity surface area; TEE = transesophageal echocardiography; TR = tricuspid regurgitation; TTE = transthoracic echocardiography.

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  Figure 2. Preprocedural CTA (A) Tricuspid valve orifice area and tricuspid annulus circumference in diastole. (B) TR orifice shape in systole. (C) Septolateral diameter of the tricuspid valve annulus in diastole. (D) Annulus to right coronary artery distance in the location of the posteroseptal commissure (sp), the midpoint of the posterior valve annulus (mp), and anteroposterior commissure (ap), respectively. CTA = computed tomographic angiography; TR = tricuspid regurgitation.

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  Figure 3. Case Example of K-Clip System Deployment (A) The corkscrew is drilled into the annulus under TTE guidance. (B) The clip arm is rotated to make it flush with the annulus under the 3D guidance of TEE. (C) The deflectable outer sheath is placed, and right coronary angiography is performed. (D) The corkscrew with the annulus tissue is raised outward to the unfolded clip arms. (E) Right coronary angiography is used to evaluate the presence of coronary stenosis and clip stability. (F) After release, angiography is performed again to assess the vascular stenosis. 3D = 3-dimensional; TEE = transesophageal echocardiography; TTE = transthoracic echocardiography.

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  Figure 4. The K-Clip Transcatheter Tricuspid Annuloplasty System (A) The K-Clip tricuspid annuloplasty system. The system comprises an anchor device, clip device, outer (16-F) and inner (15-F) sheaths, and control knobs. Control knobs are adjusted so that the distal end of the inner sheath and anchor device is parallel to the annulus and pointing to the target area. The successful capture of the annulus tissue reduces the annulus area and circumference. (B) NYHA functional class changes from baseline to 30 days after surgery. (C) TR severity at baseline, during the procedure, and 30 days after the procedure in paired analysis. (D) Grade reduction of TR severity at the procedure and 30 days after surgery. The P values for categorical variables are derived from the Wilcoxon signed-rank test. Values are mean. TR = tricuspid regurgitation.

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  Figure 5. Reduction in TR From Baseline to 30 Days With the K-Clip System (A) The mean PISA EROA decreases from 99.5 ± 77.8 mm2 to 43.8 ± 27.2 mm2. (B) The mean TR vena contracta width decreases from 12.7 ± 5.7 mm to 7.0 ± 3.8 mm. The P values for continuous variables are derived from paired Student’s t-tests. Values are mean ± SD. The error bars represent the 95% CIs. EROA = effective regurgitant orifice area; PISA = proximal isovelocity surface area; TR = tricuspid regurgitation.

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  Figure 6. The K-Clip System Reduces the TV Area and Ring Circumference From Baseline to 30 Days (A) The diastolic TV opening area decreases from 1,714.8 ± 481.9 mm2 to 1,249.5 ± 362.4 mm2 at 30 days. (B) The TV ring circumference decreases from 149.4 mm ± 20.7 to 135.7 ± 19.5 mm at 30 days. The p values for continuous variables are derived from paired Student’s t-tests. Values are mean ± SD. The error bars represent the 95% confidence intervals. CTA = computed tomographic angiography; TV = tricuspid valve.

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  Figure 7. The K-Clip System Improves the 6MWD and KCCQ Scores From Baseline to 30 Days (A) The mean 6MWD improves from 284.6 ± 111.6 m to 362.7 ± 116.5 m at 30 days. (B) The mean KCCQ score improves from 64.9 ± 15.1 to 75.9 ± 11.8. The P values for continuous variables are derived from paired Student’s t-tests. Values are mean ± SD. The error bars represent the 95% CIs. 6MWD = 6-minute walk distance; KCCQ = Kansas City Cardiomyopathy Questionnaire.

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  Central Illustration. 30-Day Outcomes From the TriStar Trial With the K-Clip System Transcatheter tricuspid valve repair using the K-Clip system is technically feasible, safe, and effective. The major adverse event and mortality rates are low. The most commonly used landing zone for the K-Clip is posteroseptal commissure (56.4%), with high coronary safety. Short-term follow-up shows that the K-Clip system is associated with a 30-day reduction in TR and improved cardiac function and quality of life. TR reduction is observed to be at least grade 1 in all patients. This effect persists at follow-up 30 days postoperatively, with a reduction of ≥2 grades in 76.9% of patients. TR = tricuspid regurgitation.