Türk Kardiyoloji Derneği Genç Kardiyologlar Bülteni - Trinity Trial – 30-day Outcomes of LuX-Valve Plus Transjugular Tricuspid Valve Replacement (Dr. Mustafa Yılmaz, Dr. Mustafa Yenerçağ)

[Türkçe]

Turkish Society of Cardiology Young Cardiologists Bulletin Year: 8 Number: 3 / 2025

Turkish Society of Cardiology
Young Cardiologists
President
Dr. Muzaffer Değertekin

Coordinator for the
Board of Directors
Dr. Ertuğrul Okuyan

Coordinator for the
Board of Directors
Dr. Can Yücel Karabay

Members
Dr. Adem Aktan
Dr. Gülşah Aktüre
Dr. Bayram Arslan
Dr. İnanç Artaç
Dr. Ahmet Oğuz Aslan
Dr. Görkem Ayhan
Dr. Ahmet Anıl Başkurt
Dr. Özkan Bekler
Dr. Oğuzhan Birdal
Dr. Yusuf Bozkurt Şahin
Dr. Serkan Bulgurluoğlu
Dr. Ümit Bulut
Dr. Veysi Can
Dr. Mustafa Candemir
Dr. Murat Çap
Dr. Göksel Çinier
Dr. Ali Çoner
Dr. Yusuf Demir
Dr. Ömer Furkan Demir
Dr. Murat Demirci
Dr. Ayşe İrem Demirtola Mammadli
Dr. Süleyman Çağan Efe
Dr. Mehmet Akif Erdöl
Dr. Kubilay Erselcan
Dr. Kerim Esenboğa
Dr. Duygu Genç
Dr. Kemal Göçer
Dr. Elif Güçlü
Dr. Arda Güler
Dr. Duygu İnan
Dr. Hasan Burak İşleyen
Dr. Muzaffer Kahyaoğlu
Dr. Sedat Kalkan
Dr. Yücel Kanal
Dr. Özkan Karaca
Dr. Ahmet Karaduman
Dr. Mustafa Karanfil
Dr. Ayhan Kol
Dr. Fatma Köksal
Dr. Mevlüt Serdar Kuyumcu
Dr. Yunus Emre Özbebek
Dr. Ahmet Özderya
Dr. Yasin Özen
Dr. Ayşenur Özkaya İbiş
Dr. Çağlar Özmen
Dr. Selvi Öztaş
Dr. Hasan Sarı
Dr. Serkan Sivri
Dr. Ali Uğur Soysal
Dr. Hüseyin Tezcan
Dr. Nazlı Turan
Dr. Berat Uğuz
Dr. Örsan Deniz Urgun
Dr. İdris Yakut
Dr. Mustafa Yenerçağ
Dr. Mehmet Fatih Yılmaz
Dr. Yakup Yiğit
Dr. Mehmet Murat Yiğitbaşı

Bulletin Editors
Dr. Muzaffer Değertekin
Dr. Can Yücel Karabay
Dr. Muzaffer Kahyaoğlu

Contributors
Dr. Ahmet Caner Canpolat
Dr. Aysu Oktay
Dr. Hadi Verdiyev
Dr. Kemal Göçer
Dr. Mehmet Altunova
Dr. Mehmet Murat Yiğitbaşı
Dr. Merve Kapçık
Dr. Muhammed Ali Söyler
Dr. Muhammet Ali Ekiz
Dr. Mustafa Yenerçağ
Dr. Mustafa Yılmaz
Dr. Özkan Karaca
Dr. Ramazan Furkan Demirkıran
Dr. Seda Kurat Güldoğmuş
Dr. Sefa Sarı
Dr. Selim Süleyman Sert
Dr. Serkan Bulguroğlu
Dr. Ülkü Nur Koç
Dr. Yücel Kanal

Trinity Trial – 30-day Outcomes of LuX-Valve Plus Transjugular Tricuspid Valve ReplacementTürk Kardiyoloji Derneği Genç Kardiyologlar Bülteni - Trinity Trial – 30-day Outcomes of LuX-Valve Plus Transjugular Tricuspid Valve Replacement (Dr. Mustafa Yılmaz, Dr. Mustafa Yenerçağ)

Prepared by: Dr. Mustafa Yılmaz, Dr. Mustafa Yenerçağ

Study Title: Trinity Trial – 30-day Outcomes of LuX-Valve Plus Transjugular Tricuspid Valve Replacement

Presented at: EuroPCR 2025

Link: https://www.europcr.com Introduction

The Trinity trial was conducted to evaluate the safety and effectiveness of the LuX-Valve Plus transjugular tricuspid valve replacement system in patients with severe tricuspid regurgitation (TR) who are at high surgical risk.

Objective

The objective of the study was to assess the safety and clinical performance of the LuX-Valve Plus system in patients with severe TR, focusing particularly on 30-day clinical outcomes, quality of life, symptom improvement, and device success.

Methods

The Trinity trial was a multicenter study that enrolled 149 patients (with 12 in the roll-in group), all treated with the LuX-Valve Plus system. Follow-ups were scheduled at 7 days, 30 days, 6 months, 12 months, and annually. The primary safety endpoint was the composite of Major Adverse Events (MAE) at 30 days. The primary performance endpoint was TR ≤2+ with no clinically significant paravalvular leak (PVL) at 30 days.

Results

Device success was reported at 96.64%, and procedural success at 91.95%. The 30-day composite adverse event rate was 14.8% for the FAS group and 14.9% including the roll-in group. Major bleeding occurred in 4%, and new pacemaker implantation in 8.7%. TR severity was reduced to ≤2+ in 95.7% of patients. NYHA class and quality of life significantly improved.

Conclusion

The LuX-Valve Plus system offers a safe and effective treatment alternative for patients with severe TR. It is supported by high device success rates, low complication rates, and improvements in quality of life.

Comment

This study highlights the promise of the LuX-Valve Plus system as a minimally invasive, anatomically adaptable solution for severe TR. Recognized by regulatory authorities like the FDA and EMA, its applicability to a wide range of anatomies is noteworthy. Long-term follow-up will be crucial to validate its sustained efficacy.