Early and late outcomes after Cardioband procedure in patients with atrial and non-atrial functional tricuspid regurgitation

In the article entitled “Performance of Transcatheter Direct Annuloplasty in Patients With Atrial and Nonatrial Functional Tricuspid Regurgitation” published on the Journal of the American College of Cardiology (JACC), the authors explored the echocardiographic and clinical outcomes up to 1 year in patients with symptomatic, severe functional tricuspid regurgitation (TR) who underwent transcatheter tricuspid valve annuloplasty (TTVA) with the Cardioband (from January 2017 until October 2022) (1). Based on echocardiographic etiology assessment, 103 patients were categorized in non-atrial functional tricuspid regurgitation (NA-FTR) and 62 patients were categorized in atrial functional tricuspid regurgitation (A-FTR). The definition A-FTR was made if the patients had tricuspid valve tenting height ≤10 mm, right ventricular (RV) midventricular diameter ≤38 mm, and left ventricular ejection fraction ≥50%. Notably, patients affected by NA-FTR, showed larger right heart chambers dimensions and coaptations gaps at baseline echo, more frequently impaired RV function and more advanced TR grade when compared with A-FTR patients. At discharge, 30 days and 1 year the echocardiography endpoints considered were reduction of TR by ≥2 grades and grade of residual TR ≤II, while clinical endpoints at 30 days and 1 year were New York Heart Association (NYHA) functional class, freedom from heart failure hospitalization (HFH) and all-cause mortality. Reduction in TR grade ≥2 grades was achieved equally in both subtypes at 30 days and 1 year, while reduction to TR grade ≤II was more frequently observed in A-FTR, which can be explained by more advanced TR grade at baseline in the comparison group (NA-FTR). In the multivariate analysis, A-FTR was a significant and independent predictor of reducing TR grade to below moderate. At 30 days, NYHA functional class I or II was present in 80.0% of A-FTR and 66.3% of NA-FTR, with the same trend at 1 year (71.4% and 64.5%, respectively). A-FTR had better survival at 1 year, with estimated 1-year mortality 6.5% for A-FTR and 23.8% for NA-FTR, whereas freedom for HFH for A-FTR and NA-FTR was 86.7% and 77.3%, respectively. Interestingly the all-cause mortality rate was strictly related to RV function with a higher survival in patients with A-FTR and nonimpaired RV function and the highest all-cause mortality rate in NA-FTR patients with impaired RV function. Tricuspid valve disease is a common pathology, approximately 4% of over 75 years old people have clinically sintomatic TR. A novel integrative classification of TR has been proposed, which includes primary TR (organic), secondary TR (functional), subdivided into atrial and ventricular forms, and cardiac implantable electronic device (CIED)-related TR. Notably, secondary atrial TR is due to right atrial (RA) enlargement leading to significant isolated annular dilation, while secondary ventricular TR is caused by RV widening or/and dysfunction leading to annulus dilatation and leaflet tethering.

Appropriate timing of intervention is crucial to avoid irreversible RV damage and organ failure.

In symptomatic, inoperable, anatomically eligible patients in whom symptomatic or prognostic improvement can be expected transcatheter tricuspid valve interventions (TTVIs) may be considered by the Heart Team at experienced Heart Valve Centres.

The indication for any TTVI should take account some characteristics: the RV grade, the valve anatomy and the comorbidities of individual patients. Those who remain symptomatic despite diuretic treatment with no RV severe dysfunction, no evidence of pre-capillary pulmonary hypertension (PHT), and no severe renal and liver dysfunction may derive the greatest benefit from TTVI. Conversely, in the others cases the procedure may be vain. Interventional cardiology team is essential for deciding about the procedure (2).

Currently, several devices are available and the choice TTVI must be based on anatomic and physiologic features, taking into account TR mechanisms, coaptation gap, jet location and grade of tethering. Annuloplasty is a type of TTVI technique and Cardioband is a direct annuloplasty system (Edwards Lifesciences, Irvine, CA, USA). The device consists of an adjustable band fixed by inserting anchors on the atrial surface of the annulus. The implant is initiated on the antero-septal commissure, continues clockwise to end after the coronary sinus and the postero-septal commissure. In order to avoid right coronary artery perforation or occlusion, an angiography is performed and a wire is placed into right coronary artery by transfemoral artery access (3). In several studies, Cardioband system has been shown to reduce TR to moderate or less and to improve symptoms (4).

Specifically, there are American studies that demonstrated Cardioband system can reduce mortality, improves quality life and functional status at 1 month (5); furthermore, at 1 year the use of Cardioband can decrease all-cause mortality and heart failure rehospitalization (6). These results are particularly encouraging, in fact the TriValve registry reports a high rate of all-cause mortality and heart failure rehospitalization for untreated or medically treated severe TR (7).

In European, Cardioband device has been approved since 2018 and it was used as the first transcatheter therapy to treat TR. Two European studies—TRI-REPAIR (Tricuspid Regurgitation Repair With Cardioband Transcatheter System) (8), and TriBAND (Transcatheter Repair of Tricuspid Regurgitation With Edwards Cardioband TR System Post Market) (9)—show significant improvements for echocardiographic and clinical parameters, at 2 years and 30 days, respectively. In addition, a Spanish study demonstrated good results for Cardioband at 1 year of follow up, patients experienced improvements in quality of life and exercise capacity (10).

Although the first European study to distinguish between AFTR and VFTR was a German observational study, in which improvement by at least two grades and three grades were similar in both groups and no significant difference in the accomplishment of TR grade of 2 or less was noted. The medium and long follow up was not considered in the study (4).

This paper is the first to analyze the procedure success and clinical outcomes at 30 days and at 1 year of follow up after Cardioband procedure, distinguishing patients affected by functional atrial and ventricular functional TR. The authors suggested the A-FTR and NA-FTR subtypes are not to two different entities but to different stages of the same disease. The A-FTR corresponds to an earlier stage of the disease. In fact, echocardiographic and cardiac computed tomographic angiography (CTA) demonstrated a different anatomy such as less right heart remodeling, lower dilated annulus and lower degree of coaptation gap at baseline. In addition, not quite statistically significantly, patients with A-FTR were found to have lower N-terminal pro-B-type natriuretic peptide levels than patients with NA-FTR. Presumably the constant volume overload leads to a dilatation of the right ventricle for this reason the NA-FTR represents a later stage of the disease. About the results there was no difference in the two groups regarding the relative reduction of annular dimensions and the improvement in NYHA class. Although A-FTR patients had better survival at 1 year, even after adjusting for the presence of a higher grade of residual TR, whereas patients with NA-FTR and impaired RV function had the highest all-cause mortality. Though, it is important to underline the number of HFHs that did not differ between the two groups. This could be explained by the retrospective nature of this study (1).

The findings in the literature demonstrate that Cardioband is a useful procedure in reducing tricuspid insufficiency and improving the quality of life in patients. The paper analyzed demonstrates the utility to distinguish the functional TR in A-AFTR and NA-FTR. Those groups are different stages of the same disease and they differ for clinical and echocardiography results after the TTVA. Therefore, it seems necessary to propose a new integrative classification into clinical practice in order to understand who can benefit most from the procedure. Further studies will be fundamental to confirm the data described. A patient tailored approach and a competent dedicated “tricuspid heart team” is mandatory to select patients for the most affordable approach and optimize outcome.

Acknowledgments

Funding: None.

Footnote

Provenance and Peer Review: This article was commissioned by the editorial office, Cardiovascular Diagnosis and Therapy. The article has undergone external peer review.

Peer Review File: Available at https://cdt.amegroups.com/article/view/10.21037/cdt-24-407/prf

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://cdt.amegroups.com/article/view/10.21037/cdt-24-407/coif). The authors have no conflicts of interest to declare.

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