Current transcatheter devices to treat functional tricuspid regurgitation with discussion of issues relevant to clinical trial design

Abstract

Functional or secondary tricuspid regurgitation (TR) has seen increased attention in recent times as relationships with clinically-relevant outcomes have come to light. Despite the association of increased mortality with significant TR, the disease remains under-recognized and thus relatively untreated. In addition, the disease itself has not been extensively studied and the interactions between annular dilatation, right heart disease and pulmonary hypertension are poorly understood. However, the high mortality and recurrence rate with current surgical replacement or repair techniques is well recognised, opening the door to transcatheter therapies for functional TR. The current perspective reviews the rationale for transcatheter solutions, describes some of the current approaches and discusses the ongoing questions of a poorly-studied condition which may limit the design of clinical trials for this disease.

Right Ventricular Longitudinal Strain Predicts Survival in Patients With Functional Tricuspid Regurgitation

“…However, all interventional devices are still in development and are far from incorporation into clinical practice. 33 In conclusion, in patients with TR, echocardiographic evaluation of RV function appears to be useful. Assessment of RV strain provides additional value for prediction of 2-year mortality.…”

Outcomes of Concomitant Maze Procedure in Tricuspid Repair for Severe Tricuspid Regurgitation

“…To determine the clinical impact of concomitant Maze procedure in patients with TR, it is crucial to identify the relevant outcomes in this study cohort. 9 10 As TR is a long-term process, not only hard endpoints including cardiac death, but soft endpoints such as rehospitalization, quality of life, functional status, or secondary hemodynamic parameters such as right ventricular function and pulmonary artery pressure might also be important to evaluate the impact of Maze procedure. 10 Our research incorporated these additional parameters to gain a deeper understanding of its benefits for patients with severe TR.…”

“…The main limitations when conducting a study analyzing the clinical impact of concomitant Maze operation in severe TR and persistent AF are as follows: 1) The inherent high mortality and morbidity rates of tricuspid valve (TV) surgery may potentially diminish the clinical impact of Maze procedure, 6 7 2) TV replacement has been associated with high perioperative and long-term mortality, as well as the potential to induce right ventricular dysfunction, which make the analysis more complicated, 7 8 3) and many patients with severe TR also require concomitant left valve surgery, making it difficult to find out appropriate clinical and echocardiographic parameters. 9 10 …”

Functional tricuspid regurgitation: Feasibility of transcatheter interventions

“…The annular reduction is then accomplished by repositioning the collars further down the crest, effectively reducing the distance between the anchors. 47 The pledget-assisted suture tricuspid annuloplasty (PASTA) device mirrors the Hetzer double-orifi ce suture procedure. 48 The fi rst in human experience resulted in annular dehiscence of the device 2 days after its insertion and this device potentially should be not be used in large friable annuli.…”