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The Use of an Inflatable Adhesive External Compression Device for Maintenance of Hemostasis following Angiography in
Mohammed H Alomari1, Mohamed M Shahin1, Cindy L Kerr1
1Division of Vascular and Interventional Radiology, Boston Children's Hospital, Boston, Massachusetts.
Insights
The SafeGuard compression device is safe and effective for maintaining hemostasis after pediatric angiography under general anesthesia. This method minimizes complications and may reduce sedation needs, allowing for earlier patient discharge.
Area of Science:
- Pediatric Interventional Radiology
- Vascular Access Management
- Medical Device Safety
Background:
- Angiography in children often requires general anesthesia, necessitating careful post-procedure hemostasis.
- Maintaining hemostasis is crucial to prevent complications and ensure patient comfort during recovery.
- Current methods may involve prolonged monitoring or additional sedation.
Purpose of the Study:
- To evaluate the safety and efficacy of the SafeGuard inflatable adhesive external compression device.
- To assess its role in posthemostasis management following pediatric angiography performed under general anesthesia.
- To determine the incidence of access-related adverse events associated with its use.
Main Methods:
- Retrospective review of medical records for 74 pediatric patients (0.4-18 years) undergoing angiography under general anesthesia.
- Application of the SafeGuard device after manual compression to achieve hemostasis.
- Assessment of patients for adverse events in the recovery unit and during follow-up.
Main Results:
- The device was used in 181 procedures, primarily on the common femoral artery.
- Low rates of adverse events were observed: minor bleeding (1.1%) and early deflation due to pain (<1%).
- Follow-up ultrasonography confirmed access artery patency in 60.2% of cases.
Conclusions:
- The SafeGuard device is a safe and effective tool for maintaining hemostasis in pediatric patients post-angiography.
- Its use simplifies post-anesthesia recovery and may reduce the need for additional sedation.
- Facilitates early discharge by ensuring stable hemostasis during the critical recovery phase.
Purpose:
To assess the safety and efficacy of the posthemostasis use of an inflatable adhesive external compression device (SafeGuard) following angiography in children performed under general anesthesia.
Materials And Methods:
Medical records of 74 children (43 females) with a mean age of 8.9 years (range, 0.4-18.0 years) and mean weight of 44.0 kg (range, 7.3-115.7 kg) in whom an inflatable adhesive external compression device was used for maintaining hemostasis following angiography under general anesthesia were retrospectively reviewed. After establishing hemostasis with manual compression, the device was applied and inflated over the arteriotomy. The patients were assessed for access-related adverse events in the recovery unit and during postprocedural follow-up.
Results:
The inflatable adhesive external compression device was utilized to maintain hemostasis following 181 angiography procedures. The mean length of the procedure was 396 minutes. The common femoral artery (n = 170, 93.9%) was the most common access, using 4-5-F vascular sheath (n = 118, 65.2%) or 3-5-F sheathless (n = 8, 12.7%) catheters. The mean time to deflation was 93 minutes. There were no adverse events other than minor bleeding from the arteriotomy after deflation (n = 2, 1.1%) and early deflation of the device because of pain (n = 1, <1%). Follow-up ultrasonography (n = 109 procedures, 60.2% at a mean follow-up of 2.2 years) demonstrated patency of the access artery.
Conclusions:
The use of an inflatable adhesive external compression device following angiography in children to maintain hemostasis during the emergence phase of anesthesia and recovery period is safe and effective. The use of this simple device may reduce the need for postprocedural sedation and facilitate early discharge.

