In JACC: Heart Failure, Mathias Orban (Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Munich, Germany) and colleagues report that transcatheter tricuspid valve repair for the management of severe tricuspid regurgitation is associated with reduced heart failure hospitalisations and improved clinical outcomes. In this interview, Orban speaks to Cardiovascular News about the emerging transcatheter options for tricuspid valve repair.
What is the natural history of tricuspid regurgitation?
Tricuspid regurgitation can be caused by structural defects of the tricuspid valve—i.e. after endocarditis, which is called primary tricuspid regurgitation. However, the vast majority of patients have secondary tricuspid regurgitation. With secondary tricuspid regurgitation, the leaflets are (at least) not severely disrupted but the whole valve apparatus is dilated. This can be due to dilatation of the right ventricle or right atrium, volume overload in dialysis patients, pulmonary hypertension, atrial fibrillation, and other mechanisms
Traditionally, what have been the management options for these patients?
If patients are found to have severe regurgitation, physicians start with diuretics as the baseline therapy. Diuretics are up titrated, which is a strategy that has its limitations in terms of symptom relief and potential complications. If a patient is operable, they should undergo surgery. That patients, especially those with isolated tricuspid regurgitation (e.g. in other words, without an operable left heart problem), are undertreated with surgery is well known and this true in both the USA and Europe. One reason for this undertreatment is that these very sick patients often have severe comorbidities; another reason is that surgical repair of tricuspid regurgitation is associated with high perioperative mortality compared with other heart surgery procedures.
In your study, you used transcatheter edge-to-edge repair. Prior to your study, what evidence was there that edge-to-edge repair would be an effective approach for managing tricuspid regurgitation?
Our group and others have previously shown that this method is effective at reducing tricuspid regurgitation, can be safely performed without severe complications, and improves heart failure related symptoms (such as limited walking distance and reduced quality of life). However, prior to our study, there were no data showing a real-world impact on the important endpoint of hospitalisation for heart failure. Hospitalisation for heart failure has a major negative effect on quality of life for these patients and represents a substantial strain for healthcare systems.
What were the key findings of your study?
We conducted the first study to focus on transcatheter tricuspid valve repair for isolated tricuspid regurgitation. Previous studies have only analysed combined mitral and tricuspid repair. In our study, we show that transcatheter tricuspid valve repair for isolated tricuspid regurgitation alone, and not in combination with mitral valve repair, can reduce the hospitalisation rate for a very vulnerable, high-risk patient cohort. We also provide a deep characterisation of these patients, with the first comprehensive assessment of concomitant medications. Our report confirms, on a larger scale, that symptoms improve up to 12 months, which has never been reported before for transcatheter tricuspid valve repair alone for isolated tricuspid regurgitation.
In your study, you looked at two different edge-to-edge repair treatments (PASCAL and TriClip). Do you have any data for how they compare with each other?
Only a few patients were treated with PASCAL because it is a novel device [when study was being conducted, PASCAL did not have CE mark approval for tricuspid repair]. So far, we have seen comparable results. However, further studies with larger patient numbers are warranted.
What do the available data show for how percutaneous annuloplasty compares with edge-to-edge repair?
Percutaneous annuloplasty for tricuspid regurgitation is also a novel approach. The first results of this approach have been promising, but patient selection is very important because of anatomic limitations. Since the number of patients treated with percutaneous annuloplasty are low compared to edge-to-edge repair, one has to wait for larger studies and long-term data. A combination of both approaches could be an interesting technique but that requires further study.
What further data are need in this area?
A large, randomised trial of isolated transcatheter tricuspid valve repair versus optimal medical therapy in isolated tricuspid valve patients is needed. In fact, one has just started in the USA [though on hold because of the pandemic]. European trials are also on their way. These trials will clarify whether this method is effectively improving prognosis.