Chatterjee, Arka

Background: Tricuspid regurgitation (TR) can lead to right ventricular failure (RVF) and poor clinical outcomes. The TriClip™ G4 transcatheter edge-to-edge repair (TEER) system has shown improved outcomes in TR patients and received FDA approval on April 2, 2024. The FDA’s Manufacturer and User Facility Device Experience (MAUDE) database collects mandatory manufacturer reports and voluntary provider reports on device-related complications. Methods: We retrieved all TriClip™-related adverse events from the MAUDE database post-FDA approval, excluding duplicate entries and literature reviews. After removing 47 literature reviews and 36 duplicate reports, 443 unique adverse event reports from 407 procedures (some with multiple events) were analyzed between April 2, 2024, and January 31, 2025. Results: SLDA (Single Leaflet Device Attachment) was the most frequent complication, occurring in 204 cases (Figure 1). Detached leaflets included septal (105 cases), anterior (46), posterior (27), lateral (3), multiple (2), and unreported. Contributing factors included poor imaging, tethered leaflet, clip-clip interaction, dense chordae, large right atrium (RA) or gap size, pacer lead, or prior valve intervention. Persistent TR was a common consequence. SLDA was addressed with additional clips in 77 cases (18 requiring multiple clips), no intervention in 55 cases (13 with significant residual TR), repeat TriClip procedures in 16 cases, and surgical repair in 4 cases. Other complications included partial SLDA (23 cases), clip deployment or gripper malfunctions (68), chordal entanglement (41), leaflet entanglement (3), and clip migration/embolization (6). Migrated clips were found in the RA, right atrial appendage, cardiac vein, or pulmonary artery; three required snare retrieval, and three were left in place. Triclip Steerable Guide Catheter (TSGC) malfunctions, such as leaks, loss of column support, and blockages, were reported in 29 cases, with 27 requiring replacement. Miscellaneous events included residual TR, leaflet grasping issues, F-knob malfunction, lock line jams, and TSGC entanglement. Clip opening during Establishing Final Arm Angle (EFAA) occurred in 25 cases, and leaflet puncture in 15 cases, with one requiring surgical intervention. Conclusion: SLDA was the most frequently reported complication following TriClip™ approval, with some cases leading to severe outcomes. Continued surveillance is crucial to assess long-term safety and optimize procedural strategies.

Background Percutaneous heart valve procedures have been increasingly performed over the past decade, yet real‐world mortality data on valvular heart disease (VHD) in the United States remain limited. Methods and Results We queried the Centers for Disease Control and Prevention's Wide‐Ranging Online Data for Epidemiologic Research database among patients ≥15 years old from 1999 to 2020. VHD and its subtypes were listed as the underlying cause of death. We calculated age‐adjusted mortality rate (AAMR) per 100 000 individuals and determined overall trends by estimating the average annual percent change using the Joinpoint regression program. Subgroup analyses were performed based on demographic and geographic factors. In the 22‐year study, there were 446 096 VHD deaths, accounting for 0.80% of all‐cause mortality (56 014 102 people) and 2.38% of the total cardiovascular mortality (18 759 451 people). Aortic stenosis recorded the highest mortality of VHD‐related death in both male (109 529, 61.74%) and female (166 930, 62.13%) populations. The AAMR of VHD has declined from 8.4 (95% CI, 8.2–8.5) to 6.6 (95% CI, 6.5–6.7) per 100 000 population. Similar decreasing AAMR trends were also seen for the VHD subtypes. Men recorded higher AAMR for aortic stenosis and aortic regurgitation, whereas women had higher AAMR for mitral stenosis and mitral regurgitation. Mitral regurgitation had the highest change in average annual percent change in AAMR. Conclusions The mortality rate of VHD among the US population has declined over the past 2 decades. This highlights the likely efficacy of increasing surveillance and advancement in the management of VHD, resulting in improved outcomes.