Tricuspid regurgitation, CE mark for Evoque transcatheter system

Saia (Gise): “Tricuspid valve replacement a therapy for those who had no treatment options”

Edwards Lifesciences’ Evoque* transcatheter tricuspid valve replacement system has received the CE Mark for the treatment of patients with tricuspid regurgitation. The system is the first transcatheter valve replacement therapy in the world to receive approval for the treatment of patients with tricuspid valve disease, subject to debilitating and disabling symptoms who, to date – explains a note – did not have adequate solutions .

“The Evoque system – states Francesco Saia, president of the Italian Society of Interventional Cardiology (Gise) – allows the replacement of the tricuspid valve, eliminating insufficiency in a vast range of anatomies, with a significant improvement in the patients’ quality of life. Thank you To this system today there is a therapy for the many people who until now had no treatment options”. This technology, according to the president of the National Association of Hospital Cardiologists (Anmco), Fabrizio Oliva, “offers an important treatment option in patients with heart failure and severe tricuspid insufficiency”.

The results on the superiority of the transcatheter system compared to pharmacological therapy from the Triscend II study were recently presented at the 35th Transcatheter Cardiovascular Therapeutics (Tct) 2023 conference. The randomized and controlled study evaluated the safety and effectiveness of the innovative replacement system of the tricuspid valve in combination with the best available drug therapy, compared to drug treatment alone. In the first 150 patients treated, all with severe tricuspid regurgitation, the system allowed successful valve replacement in 95.8% of cases, reaching the primary safety endpoint at 30 days and both primary efficacy endpoints at 6 months, demonstrating the superiority of this system compared to pharmacological therapy alone. Excellent results were also achieved in terms of improvement in quality of life at six months.

In detail, the rate of major adverse events was 27.4% at 30 days; 98.8% of patients who started from a severe level of insufficiency reached a moderate or lower level and 93.8% reached a mild or lower level; the Evoque system, combined with pharmacological therapy, compared to pharmacological therapy alone, showed significantly higher functional and quality of life outcomes at 6 months, as emerges from the evaluation of the reference indices: Kansas City Cardiomyopathy Questionnaire (Kccq), New York Heart Association (Nyha) and 6-Minute Walking Distance (6Mwd).

“People with severe tricuspid insufficiency – recalls Luigi Mazzei, General Manager of Edwards Lifesciences Italia – endure debilitating symptoms that have a strong impact on their quality of life. For this reason they urgently need a safe and effective treatment, as demonstrated by the speed with which the patients were enrolled in the study. These data – he adds – add to the promising results of the Triscend study, already previously published, and contribute to increasing the clinical evidence to support our medical innovations, aimed at offering cutting-edge treatments to an ever-increasing number of people.”