By Jeffrey Zimmet, MD, PhD
Synopsis: This review of complications seen in real-world practice with the Evoque transcatheter tricuspid valve highlights the need for careful patient selection and operator training with this technology.
Source: Lupu L, Rogers T, Haberman D, et al. Adverse events reported for the Evoque transcatheter tricuspid valve replacement: A MAUDE database analysis. JACC Cardiovasc Interv. 2025;18(11):1489-1491.
The study “Adverse Events Reported for the Evoque Transcatheter Tricuspid Valve Replacement: A MAUDE Database Analysis” investigates the real-world safety profile of the Evoque transcatheter tricuspid valve replacement (TTVR) system, which became the first U.S. Food and Drug Administration (FDA)-approved device of its kind in February 2024.
Although the pivotal trial for Evoque demonstrated improvements in symptoms and quality of life, it involved a relatively small patient cohort and noted a significant incidence of adverse events, particularly severe bleeding and conduction disturbances requiring permanent pacing. Recognizing the need for broader safety data, the authors analyzed reports from the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database covering the first year of Evoque’s clinical use. This approach provides an early look at complications encountered outside the confines of a clinical trial, although it is limited by the absence of a known denominator and potential reporting biases.
The analysis identified 150 reports documenting 158 adverse events. The most commonly reported complication was bradycardia or high-degree atrioventricular (AV) block, accounting for 44.3% of the reported cases. These 65 patients required permanent pacemaker implantation. Two deaths were reported. These conduction disturbances were detected at various intervals: intra-procedurally, within two days, and up to three months post-procedure. Device malposition, migration, or embolization was the second most frequent complication, occurring in 33 patients (20.9%) and resulting in six deaths.
Most of these events were recognized during the procedure, with management strategies ranging from transcatheter valve-in-valve implantation to surgical intervention. Leaflet thickening or thrombus formation was reported in 20 patients (12.7%), with clinical or hemodynamic consequences in most cases; management included thrombolysis, further valve-in-valve procedures, and surgery.
Other notable complications included cardiac tamponade in eight patients (5.1%), with half resulting in death, and venous injury or bleeding in another eight patients, with two deaths. There also were five cases of ventricular tachycardia, fibrillation, or cardiac arrest, some intra-procedural and others occurring days later. Mechanical failure of the delivery system was observed in four patients (2.5%), all caused by nose cone separation. In one instance, the detached component embolized to the pulmonary arteries, although the patient remained asymptomatic. Manufacturer investigation into these device failures did not reveal a systemic production issue.
The authors concluded that this is the first real-world report of adverse events associated with the Evoque system. Although some complications — such as AV block, cardiac tamponade, vascular injury, and valve thrombosis — also were seen in the pivotal trial, the real-world data reveal additional concerns, particularly device malposition, migration, and delivery system malfunction. These issues may reflect a procedural learning curve and broader patient selection outside the strict anatomical criteria of the trial.
The authors caution that the true incidence of complications cannot be determined from voluntary reports and that causality remains uncertain in the absence of on-site evaluation or adjudication. They recommend careful patient selection and continued collection of real-world data as Evoque is adopted more widely.
Commentary
For the general cardiology community, these findings carry important implications. The Evoque system represents a significant advance for patients with severe tricuspid regurgitation, a population with limited therapeutic options. However, the high frequency of conduction disturbances requiring permanent pacing highlights the anatomical proximity of the tricuspid annulus to the cardiac conduction system, underscoring the need for careful pre-procedural assessment and patient counseling. The emergence of device malposition and migration as frequent and sometimes fatal complications is particularly concerning and likely reflects both the complexity of tricuspid anatomy and the early phase of operator experience with the device.
Leaflet thrombosis and thickening, although anticipated, appear to be clinically significant and may prompt reevaluation of antithrombotic protocols following TTVR. The occurrence of mechanical failures of the delivery system, although rare, signals a need for ongoing device refinement and operator training. These complications, especially those not observed in the pivotal trial, suggest that the transition from controlled study environments to routine clinical practice can introduce new risks, particularly as indications expand and less experienced centers adopt the technology.
As the Evoque system becomes more widely used, these early real-world findings emphasize the importance of multidisciplinary heart team evaluation, judicious patient selection, and robust post-market surveillance. Transparent reporting and critical analysis of complications will be essential for refining procedural techniques, improving device design, and, ultimately, optimizing patient outcomes. For now, clinicians should approach TTVR with Evoque with both optimism and caution, recognizing its potential benefits but remaining vigilant for a spectrum of complications that may be broader than initially anticipated.
Jeffrey Zimmet, MD, PhD, is Associate Professor of Medicine, University of California, San Francisco; Director, Cardiac Catheterization Laboratory, San Francisco VA Medical Center.
