Debra L. Beck, MSc, and Eugene Braunwald, MD

There are few treatment options for patients with secondary tricuspid regurgitation (TR). Recently, small studies have shown that the Cardioband tricuspid valve reconstruction system (Edwards Lifesciences) can be safely used to treat severe TR. This transcatheter device mimics the surgical annuloplasty approach and has received CE approval for the routine treatment of TR. However, the published evidence on this device is limited. 

Korber and colleagues report the first real-world safety and efficacy data on 60 patients treated with the Cardioband device for severe TR. All patients were treated at one of 4 high-volume German centers. 

Median age was 76 years, 61.7% were female, median EuroScore II was 3.9%, heart failure with preserved ejection fraction (HFpEF) was present in 78%, and 81.7% were in NYHA class III/IV heart failure, with peripheral edema in 80%. Severe TR was found in 48.3%, massive TR in 30%, and torrential TR in 21.7% 

The primary efficacy endpoint (technical success with a reduction of TR ≥2 grades at discharge) was achieved in 45%. A somewhat higher proportion (60.3%) were discharged with less-than-severe TR. Technical success and at least a 1 grade reduction in TR was seen in 88% of patients. At discharge only 3.4% of patients still had massive or torrential TR. Vena contracta was reduced by 47% from 12.9 to 7.0 mm (p<0.001). 

Overall, the most patients (81.7%) improved by at least by 1 NYHA class. At clinical follow-up (median, 92 days), 81.3% of patients presented in the New York Heart Association class I or II. 

The primary safety endpoint of major adverse events (death, myocardial infarction, cardiothoracic surgery, and stroke) at 30 days was observed in 4 patients, including 2 in-hospital deaths, both not device related. Right coronary artery complications (vessel perforation or stent implantation) occurred in 9 patients (15%). 

In the later procedures, procedural time decreased (from 298 to 185 minutes; p<0.001) with efficacy remaining similar. 

Summary

The investigators concluded that, in this first real-world experience, transcatheter treatment of advanced secondary TR using direct annuloplasty is “feasible and reasonably safe early in the learning curve, with significant symptomatic benefit,” albeit at high-volume centers. More study is needed to better understand long-term outcomes and patient prognosis. 

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