Intermediate Outcomes After Coarctation Stenting | Journal Scan
What is the safety and efficacy of the Cheatham Platinum stent when used in children and adults with native or recurrent coarctation?
COAST was a prospective, multicenter, single-arm clinical study involving 19 pediatric cardiology centers in the United States. A total of 105 patients underwent attempted implantation, with 104 successes. Follow-up evaluations were performed prior to discharge and at 1, 6, 12, 24, 48, and 60 months post-procedure. Four primary outcome variables were defined: two efficacy outcomes (reduction in upper to lower extremity systolic blood pressure measurements, and hospital length of stay) and two safety outcomes (occurrence of any serious or somewhat serious adverse event attributed to the stent or implantation, and occurrence of paradoxical hypertension).
There were no procedural deaths, serious adverse events, or surgical intervention. All patients experienced immediate reduction in upper to lower extremity blood pressure difference with sustained improvement to 2 years. Rates of hypertension and medication use decreased from baseline to 12 months, and remained largely unchanged at 2 years. Six aortic aneurysms were identified, five were successfully treated with cover stent placement, and one resolved without intervention. Stent fractures were noted in two patients at 1 year, and 11 patients at 2 years, with evidence of fracture progression. To date, only larger stent diameter was associated with stent fracture. Twelve additional fractures occurred after 2 years. No fracture has resulted in loss of stent integrity, stent embolization, aortic wall injury, or reobstruction. Nine reinterventions occurred in the first 2 years for stent redilation and address of aneurysms, and 10 additional reinterventions after 2 years.
The authors concluded that the Cheatham Platinum stent is safe for aortic coarctation and associated with persistent relief of obstruction.
This study shows that use of the Cheatham Platinum stent in children and adults with coarctation is safe and associated with persistent relief of aortic obstruction up to 2 years after implant. Early and late aortic aneurysms occur, both within and at the margins of the stent, and require long-term vigilance. Stent fractures also occur, and can progress over time and appear associated with stent implantation size. Given significant limitations and lack of a comparator arm, additional prospective studies with longer-term follow-up are indicated.
Clinical Topics: Cardiac Surgery, Congenital Heart Disease and Pediatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Prevention, Vascular Medicine, Aortic Surgery, Cardiac Surgery and CHD and Pediatrics, Congenital Heart Disease, CHD and Pediatrics and Interventions, CHD and Pediatrics and Prevention, CHD and Pediatrics and Quality Improvement, Interventions and Structural Heart Disease, Interventions and Vascular Medicine, Hypertension
Keywords: Aneurysm, Aortic Aneurysm, Aortic Coarctation, Aortic Diseases, Blood Pressure, Catheterization, Follow-Up Studies, Heart Defects, Congenital, Hypertension, Length of Stay, Lower Extremity, Platinum, Pediatrics, Prospective Studies, Stents, Upper Extremity
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