Modes of failure of guide catheter extensions: Insights from the MAUDE database.

OBJECTIVES: Guide catheter extensions (GCEs) are commonly used to facilitate percutaneous coronary interventions (PCIs). We investigated the incidence and modes of failure of GCEs.. METHODS: Data from the Manufacturer and User Facility Device Experience (MAUDE) database between 2012 and 2022 were used to investigate the most common modes of failure and related adverse events with the use of GCEs. We performed analysis of 4 commonly used catheters: GuideLiner (Teleflex), Guidezilla (Boston Scientific), TrapLiner (Teleflex), and Telescope (Medtronic). The first event reported for GuideLiner was in 2012, Guidezilla in 2018, TrapLiner in 2017, and Telescope in 2019. RESULTS: During the study period, a total of 651 events were reported to the database. A total of 429 true GCE device failures were identified: 59 (14%) for GuideLiner, 297 (69%) for Guidezilla, 47 (11%) TrapLiner, and 26 (6%) for Telescope. Catheter detachment or fracture was the most frequently reported device failure for all 4 GCEs; these failures included shaft fractures, tip deformations, and collar detachments. We identified 222 reported events as unspecified adverse events; these events included device-to-device incompatibility, difficulty to advance, and device fractures outside the patient body. Only 58 (8.9%) events resulted in patient complication. Of these, coronary artery dissection was the most frequently reported complication. CONCLUSIONS: Device detachment/fracture is the most common mode of device failure in all 4 GCEs, and coronary dissection is the most common patient complication.

Comparison of Figure-of-Eight Suture and Perclose ProGlide Suture-Mediated Closure in Large Bore Venous Access Hemostasis: A Randomized Controlled Trial.

Suture-mediated closure device and Figure-of-Eight suture are commonly used to achieve hemostasis after use of large bore venous access. Although both methods of closure are commonly used in clinical practice, a head-to-head comparison in a controlled setting has not been performed. Patients presenting to a single center for elective left atrial appendage occlusion or transcatheter edge-to-edge mitral valve repair were randomized to large bore venous closure using the Perclose ProGlide suture-based closure or a Figure-of-Eight suture closure. The patients were followed for 1 month after the procedure. Primary outcome, a composite of access site large ecchymosis, hematoma, infection, pain, need for unscheduled venous ultrasound and need for transfusion, was compared between the 2 arms. A total of 40 patients were randomized in a 1:1 fashion to the 2 venous closure strategies. Baseline characteristics were similar between the 2 groups. Perclose ProGlide arm required use of more devices for hemostasis (1.5 ± 0.5 vs 1 ± 0 respectively, p <0.0001), and there was a significant difference in the cost of closure device ($367.00 ± 122.00 vs $1.00 ± 0 respectively, p <0.001). At 1 month post-procedure, the primary outcome occurred in 4 patients (20%) in the Perclose arm and 7 (35%) patients in the Figure-of-Eight arm, a difference that was not statistically significant (p = 0.48). Time to hemostasis between Figure-of-Eight and Perclose arms did not reach statistical significance (2.5 ± 2.1 vs 3.7 ± 2.3, p = 0.09). In conclusion, both Perclose ProGlide suture-based device and Figure-of-Eight closure are equally feasible and safe for patients who underwent large bore venous access. Figure-of-Eight-based closure is more cost effective.