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Experience with the Cardiva Boomerang Catalyst system in pediatric cardiac catheterization
Sharon Seltzer1, Juan Carlos Alejos, Daniel S Levi
1Division of Pediatric Cardiology, UCLA Mattel Children's Hospital, Los Angeles, California, USA. sseltzer@mednet.ucla.edu
Insights
The Cardiva Boomerang Catalyst system provides safe and effective vascular closure in pediatric patients undergoing cardiac catheterization. This device achieved successful hemostasis without significant differences in procedure time compared to manual methods.
Area of Science:
- Pediatric Cardiology
- Vascular Surgery
- Medical Device Technology
Background:
- Pediatric cardiac interventions require effective and safe hemostasis methods.
- The Cardiva Boomerang Catalyst system offers a solution for vascular closure without leaving residual foreign material, crucial for re-access.
- This device is suitable for small sheaths (4Fr) with minimal orientation and a low reported complication rate.
Purpose of the Study:
- To evaluate the safety and efficacy of the Cardiva Boomerang Catalyst vascular closure system.
- To assess its performance in pediatric patients undergoing cardiac catheterization via femoral and internal jugular access.
Main Methods:
- A retrospective study comparing the Boomerang system with manual hemostasis in pediatric patients (18 months-21 years).
- Patients received 4-8Fr sheaths, and data on anthropometrics, procedure type, activated clotting time, sheath size, and procedure times were collected.
- Comparison included time to hemostasis and extubation between the Boomerang and manual hemostasis groups.
Main Results:
- The Boomerang system was deployed in 46 instances across 31 pediatric patients, compared to 40 patients with manual hemostasis.
- Device success for hemostasis was achieved in 85% of Boomerang deployments.
- No significant differences were observed in time to hemostasis or extubation; no major complications occurred.
Conclusions:
- The Boomerang system is a safe and effective method for achieving vascular hemostasis in pediatric patients.
- It is suitable for both femoral and internal jugular venous access.
- The system demonstrated comparable hemostasis and extubation times to manual compression.
Objectives:
We studied the safety and efficacy of the Cardiva Boomerang Catalyst vascular closure system in pediatric patients after cardiac catheterization with access in femoral and internal jugular vessels.
Background:
Recurrent catheterization and advances in pediatric interventions increase the need for easy hemostasis without a residual foreign body that may prevent re-accessing the vessel. The Boomerang can be deployed in sheaths as small as 4Fr without residual foreign body, with minimal orientation needed, and few complications reported.
Methods:
In a two-month period, all patients between 18 months and 21 years old catheterized with 4-8Fr sheaths less than 15 cm long were eligible for Boomerang placement. These were compared retrospectively with control patients with manual hemostasis. Anthropomorphic measurements, procedure type, activated clotting time, and sheath size as well as total times of cases, intubation, hemostasis, and extubation were compared between the two groups.
Results:
Forty-six Boomerangs were deployed in 31 patients and compared with 40 patients with manual hemostasis. Boomerangs were deployed in femoral vessels and the internal jugular vein. Device success with hemostasis was achieved in 39 patients (85%). There were no significant differences in time to hemostasis or extubation between the two groups. No major complications or operator error occurred, including hematoma, transfusion, retroperitoneal bleed, infection, vessel occlusion, or need for surgery.
Conclusions:
The Boomerang is a safe and easy means of achieving hemostasis in the pediatric population, in femoral vessels as well as internal jugular veins. Its times to hemostasis and extubation were not significantly different from manual hold.
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