Catheter‐related and clinical complications associated with QDOT MICROTM Ablation Catheter

Abstract

AbstractIntroductionThe QDOT MICROTM Ablation Catheter is a next‐generation ablation catheter that allows for high‐power ablation up to 90 watts.MethodsWe aimed to assess AE associated with the QDOT MICROTM catheter using the MAUDE database. A MAUDE database search was conducted on May 25, 2024, to capture all AEs (since FDA approval) associated with this ablation catheter.ResultsA total of 302 AEs from November 23, 2022, to April 30, 2024, were reported including 148 (49%) catheter‐related issues and 154 (51%) clinical complications. Among the catheter‐related issues, physical catheter damage (74.3%, n = 110) was most common, followed by communication or display issue (10.8%, n = 16), irrigation issue (9.5%, n = 14), signal issue or artifact (3.4%, n = 5), and inaccurate temperature measurement (2.0%, n = 3). Regarding clinical complications, the most common AE was pericardial effusion (43.5%, n = 67), followed by char formation (11.7%, n = 18), catheter thrombosis (7.1%, n = 11), stroke (7.1%, n = 11), pericarditis (7.1%, n = 11), esophageal complications (6.5%, n = 10), phrenic nerve palsy (3.9%, n = 6), cardiac arrest (3.9%, n = 6), significant AV block (3.9%, n = 6), pulmonary vein stenosis (3.2%, n = 5), coronary artery spasm (1.3%, n = 2), and pulmonary embolism (0.6%, n = 1). There were 11 deaths (five related to esophageal complications, five related to cardiac arrest, and one related to pericardial effusion with cardiac tamponade).ConclusionAs high‐power ablation strategy with novel ablation catheters is becoming more widely utilized, operators must be aware of potential catheter‐related issues and clinical complications that may arise. More data are needed to further evaluate risks of these complications to improve the catheter's safety and efficacy.