Post by Lior Lupu

🚀 Thrilled to share that our study—the first real-world analysis of adverse events reported for the Evoque transcatheter tricuspid valve replacement—has just been published in JACC: Cardiovascular Interventions! https://lnkd.in/e3VqU5Vg Using the FDA MAUDE database, we reviewed every report filed in the first year after approval (2 Feb 2024 – 1 Feb 2025) and uncovered several adverse events never observed in the pivotal trial. Two notable examples: • Device malposition / migration / embolization – the second most common event; likely linked to early operator learning curves and a broader, less-selected patient spectrum. • Nose-cone detachment – 4 reports (2.5 %) hint at a potential device-integrity issue that calls for investigation and operator vigilance. Snapshot of 158 reported events (percent of reports; true incidence unknown) 1️⃣ AV block / bradycardia – 44.3 % 2️⃣ Malposition / migration / embolization – 20.9 % 3️⃣ Leaflet thrombosis – 12.7 % 4️⃣ Cardiac tamponade – 5.1 % 5️⃣ Venous injury / bleeding – 5.1 % 6️⃣ Arrhythmia / cardiac arrest – 3.2 % 7️⃣ Delivery-catheter failure (nose-cone) – 2.5 % Take-home: Early signals stress the importance of careful patient selection, meticulous implantation technique, and ongoing post-market surveillance as Evoque adoption grows. 🙏 Heartfelt thanks to my amazing co-authors—Toby Rogers, Dan Haberman, Matteo Cellamare, Kalyan Chitturi, Abhishek chaturvedi, Waiel Abusnina M.D, Itsik Ben-Dor, Lowell Satler, MD, and Ron Waksman—for their guidance, support, and hard work on this project! #Evoque #TTVR #StructuralHeart #MAUDE #JACCInterventions #CardioTwitter JACC Journals