Data from the TriValve Registry—an international multicentre, retrospective, multidevice, registry evaluating interventional tricuspid repair—indicates that interventional edge-to-edge repair (MitraClip, Abbott) to manage patients with tricuspid regurgitation is associated with a high rate of procedural success, durable tricuspid regurgitation reduction at one-year, and significant symptomatic improvement
Speaking at the 2018 Transcatheter Cardiovascular Therapeutics (TCT) meeting (21–25 September, San Diego, USA), Jörg Hausleiter (Ludwig-Maximilians Universität München, Munich, Germany) commented that there was an “unmet” need for transcatheter treatment of high-risk patients with symptomatic tricuspid regurgitation. He added that while MitraClip has been “successfully applied with off-label/compassionate use programmes in selected patients”, the impact of the approach on clinical outcomes beyond 30 days was unknown.
Therefore, Hausleiter and colleagues performed a subgroup analysis of patients who received the MitraClip in the TriValve registry. The main outcome measures were all-cause mortality, unplanned hospitalisations, NYHA Class, presence of peripheral oedema, and tricuspid regurgitation. Of 249 patients who received MitraClip in the registry, 77% had a successful procedure. Hausleiter reported that the independent predictors for procedural failure were the jet location of the tricuspid regurgitation, the tricuspid regurgitation effective regurgitant orifice area, tenting area, and leaflet gap.
At one year, based on Kaplan-Meier survival estimates, 79.7% of patients were still alive. Furthermore, 65.3% were free from mortality and unplanned hospitalisation for heart failure. Also, significantly more patients who had a successful procedure were free from mortality/rehospitalisation for heart failure compared with those who had a failed procedure: 70.1% vs. 49.7% (log rank p<0.001). This meant that procedural failure was an independent predictor of mortality, which Hausleiter suggested meant “edge-to-edge repair might impact survival in this high-risk patient population”.
In terms of clinical improvement, there was a significant improvement in NYHA Class with 69% of patients in NYHA Class I or II by one year (most patients were in Class III or IV at baseline). The percentage of patients with peripheral oedema reduced from 84% at baseline to 26% at follow-up.
“The valve repair resulted in a durable tricuspid regurgitation at one-year follow-up, which was associated with a significant symptomatic improvement. Considering the sick and frail patient cohort, the absolute one-year mortality rate of 17.7% is remarkably low,” Hausleiter concluded.