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Published on: October 26, 2016
Initial experience with the cook formula balloon expandable stent in congenital heart disease
Daniel Quandt1, Bharat Ramchandani, Vinay Bhole
1The Heart Unit, Birmingham Children's Hospital, Birmingham, United Kingdom.
Insights
The Cook Formula stent allows significant overdilation without shortening, enabling precise placement in children with congenital heart disease. This versatile balloon-expandable stent is ideal for complex pediatric cardiac interventions.
Area of Science:
- Interventional Cardiology
- Pediatric Cardiac Surgery
- Biomedical Engineering
Background:
- Balloon-expandable stents are crucial for treating congenital heart disease in children.
- Growing children require stents to be dilated to larger diameters over time.
- The Cook Formula stent is an open-cell, 316 stainless steel design approved for peripheral vascular applications.
Purpose of the Study:
- To evaluate the performance of the Cook Formula stent in pediatric congenital heart disease.
- To assess the stent's ability to be overdilated and its impact on stent length.
- To determine the stent's suitability for various complex pediatric cardiac interventions.
Main Methods:
- 112 Cook Formula stents were implanted in 97 children over 27 months following ex vivo testing.
- Stents were delivered via 4-7F sheaths or guide catheters.
- Implantation sites included the right ventricular outflow tract, branch pulmonary arteries, and conduits.
Main Results:
- Bench testing showed no stent shortening upon dilatation to nominal or greater diameters (5mm to 10mm, 10mm to 20mm).
- Excellent stent tracking and delivery were observed.
- Sixty-one stents (54%) were overdilated; no stent fractures occurred. Radial strength was good, but conformability was limited.
Conclusions:
- The Cook Formula stent can be significantly overdilated with minimal shortening, facilitating precise placement and reduced vessel protrusion.
- Its versatility makes it a valuable option for catheter-based treatment of complex congenital heart disease in pediatric patients.
Introduction:
Balloon expandable stents are an integral part in the catheter treatment of congenital heart disease. In the growing child, stents require dilatation to greater diameters over time. The Cook Formula stent is a recent 316 stainless steel open-cell design licensed for peripheral vascular work.
Methods:
Following extensive ex vivo studies, 112 stents were implanted in 97 children [median age 3.9 (0.01-17.6) years; median weight 13.7 (2.4-62.8) kg] over a 27-month (Oct 2011-Dec 2013) period.
Results:
Bench testing revealed that there was no stent shortening for dilatation to nominal diameter and beyond. The 5 mm stents could be dilated up to 10 mm, and the 10 mm stents to 20 mm. Stents were implanted through 4-7F sheaths or guide catheters over appropriate wires. Stent tracking and delivery was excellent. Twenty-three stents were implanted in the right ventricular outflow tract in Fallot-type lesions, 53 for branch pulmonary artery stenosis (22 post cavopulmonary shunt/Fontan), 14 conduit stenosis, 13 Fontan fenestrations, 3 PDA in hybrid stage I Norwood, 5 in coarctation, and 1 for SVC obstruction. Sixty-one stents (54%) were overdilated. There were no stent fractures. Radial strength was very good, whereas stent conformability was limited.
Conclusions:
The Cook Formula stent is a premounted balloon-expandable stent that can be significantly overdilated with virtually no shortening allowing for precise placement and minimal protrusion into adjacent vessels. The Formula stent is a very versatile addition to the range of stents for use in the catheter treatment of complex congenital heart disease in children. © 2014 Wiley Periodicals, Inc.
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