Long-term outcomes of percutaneous tricuspid annuloplasty with Cardioband device

Abstract

Aims Severe tricuspid regurgitation (TR) has adverse effects on outcomes, with limited therapeutic options. We report the outcomes of patients undergoing percutaneous annuloplasty as a treatment of ≥severe functional TR in a single centre. Methods and results Prospective, single-arm, single-centre study that enrolled 24 consecutive patients with at least severe functional TR undergoing percutaneous annuloplasty with Cardioband system between 2019 and 2021. Clinical and echocardiographic data were prospectively collected, with a mean follow-up of 279 ± 246 days. At baseline, 66.6% were in New York Heart Association (NYHA) Classes III and IV and 100% had significant oedema. Technical success was 91.6%. At the end of follow-up, there was one death. Echocardiography showed a significant reduction in septolateral annular diameter of 10.4 mm (P < 0.001) that remained stable at the end of follow-up. The severity of the TR was also reduced. About 81.8% of patients were in NYHA Classes I and II. The number of patients with significant oedema decreased to 46% (P = 0.01). Six-minute walk distance improved by 68.8 m (P = 0.12). Conclusion Percutaneous annuloplasty with Cardioband system is an effective and safe treatment for patients with symptomatic, ≥severe functional TR. Annular reduction and TR severity reduction remained significant and sustained for 1 year. Patients experienced improvements in quality of life and exercise capacity.

Right ventricle assessment before tricuspid valve interventions

“…Therefore, percutaneous treatment of severe tricuspid regurgitation has shown long-lasting efficacy, improvement in symptom status and low rates of mortality and hospitalizations for heart failure. In certain scenarios emphasized in clinical trials, it could be indicated rather than surgery 43–47 . The evidence of right ventricular reverse remodeling was independently associated with improved survival especially in elderly patients with heart failure 1–4 …”

“…Regarding Cardioband, several studies 45,46 evaluated the right ventricular reverse remodeling in severe-to-massive tricuspid regurgitation patients after tricuspid valve repair through percutaneous annuloplasty using the Cardioband system and demonstrated no statistically significant changes in TAPSE and FAC.…”

“…For new transcatheter device therapies, Perlman et al 51 highlighted that after 1 year of implantation of the FORMA transcatheter tricuspid spacer device, there was a significant improvement in right ventricular function at 1-year follow-up evaluated through TAPSE, S’TDI, RVBD RVMD, PASP. It is demonstrated that percutaneous tricuspid valve intervention reduces mortality and improves right ventricular function which is considered an independent predictor of mortality before and after tricuspid regurgitation intervention 29,43–55 …”

“…In addition, the transcatheter edge-to-edge tricuspid repair system, especially TriClip, compared with medical therapy, improved the right ventricular end-diastolic dimension (P < 0.0001) and TAPSE (P ¼ 0.015) in patients with severe tricuspid regurgitation. Regarding Cardioband, several studies 45,46 evaluated the right ventricular reverse remodeling in severe-to-massive tricuspid regurgitation patients after tricuspid valve repair through percutaneous annuloplasty using the Cardioband system and demonstrated no statistically significant changes in TAPSE and FAC.…”

“…29,[43][44][45][46][47][48][49][50][51][52][53][54][55] Right ventricle assessment Cersosimo et al 99Table2RV function in preoperative and postoperative in severe tricuspid regurgitation percutaneous treatment…”