Use of the SafeGuard Pressure-Assisted Dressing for Patients Less than 15 kg Following Cardiac Catheterization

Jill Dykstra, RN and Kathy Laird, RN Congenital Heart Institute at the Arnold Palmer Hospital for Children, Orlando, Florida
Jill Dykstra, RN and Kathy Laird, RN Congenital Heart Institute at the Arnold Palmer Hospital for Children, Orlando, Florida
Arnold Palmer Hospital is a 158-bed facility which serves the needs of children in central Florida. Since partnering with Miami Children's Hospital in 2002 to form the Congenital Heart Institute, the volume of patients rotating through the cardiac catheterization laboratory has steadily risen. In 2005, 177 patients were seen in our catheterization lab with 161 undergoing a cardiac catheterization. Fifty-eight percent of those patients were children under 15 kg. In 2006, to date, 200 procedures have been performed. Of those 200 procedures, 148 were cardiac catheterizations, with 57% children under 15 kg. Due to our increasing volume of infants and children, finding a reliable, simple and effective method for maintaining hemostasis has become a priority. The Safeguard device (Datascope Interventional, Mahwah, NJ) is a post-hemostasis management device which consists of a built-in inflatable bulb allowing for consistent, mechanical pressure. The inflation pressure can be adjusted to meet the patient's needs. The Safeguard device design also includes a clear window that enables staff to assess the site without removing the dressing. Finally, the Safeguard device does not restrict mobility and allows for parental contact immediately post-procedure. Prior to implementation of the Safeguard hemostasis device, methods for maintaining hemostasis included pressure dressings that did not allow for the parents to hold the infant, were uncomfortable upon removal and proved to be very ineffective at decreasing the rate of post-procedure recurrent bleeding. Although a larger (24 cm) Safeguard device was available for use, it was not recommended for children under 10 kg. A change of practice was initiated upon development of a 12 cm Safeguard device, ideal for the patient population which is less than 10 kg. Training prior to product implementation consisted of a 30-minute staff in-service on instructions for use, contraindications and product demonstration. Since the Safeguard device does not utilize any ancillary equipment or straps, staff training was very simple. Our procedure for using the Safeguard hemostasis device consists of pulling sheaths post-procedure and obtaining hemostasis. Once hemostasis is achieved, the device is applied and the bulb is filled with enough air to maintain hemostasis while preserving perfusion to the distal area. We recently reviewed our initial experience with the infant device. From 4/14/2005 to 11/2/2005, 32 patients undergoing 38 procedures had a Safeguard applied to 43 femoral sites to maintain hemostasis following cardiac catheterization. Of the 32 patients presenting for a cardiac catheterization, three patients were on mechanical cardiopulmonary support (CPS), which represents the highest risk for bleeding locally following catheterization. At the time of the procedure, the patient mean age was 7.2 months ± 8.92 months (median 4.1, range 6 days to 39 months) and the mean weight was 5.85 kg ± 2.8 kg (range 2.5 to 13.3 kg.). Access site associated with subsequent Safeguard application was venous-only (n = 6), arterial-only (n = 7) or both artery and vein (n = 25). Sheath size ranged from 3F to 7F. In this patient cohort, recurrent bleeding after leaving the cardiac catheterization lab was rare (n = 1) and this occurred in one of the anticoagulated patients on CPS. No complications related to the Safeguard were encountered. Based on this experience, we reviewed our incidence of re-bleeding in the 12 months immediately before our use of the Safeguard device. In the previous 12-month period, we experienced seven re-bleeds associated with 67 procedures. These patients would have been eligible for a Safeguard device in the current era. Perceived advantages to Safeguard use from the nursing staff were maintenance of hemostasis with the non-compliant patient, ability to visualize access site, maximizing staff resources, increased mobility of patient, easy application and maintenance with simple adjustment of pressure, decreased patient and parent fear from occurrences of re-bleeds. Based on this review and our accumulating positive experience, the infant Safeguard device has become our routine practice for achieving and maintaining hemostasis post-cardiac catheterization. The authors can be contacted at Jill.Dykstra (at) orhs. org