Original Research Articles
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Journal of Structural Heart Disease, June 2016, Volume 2, Issue 3:79-86
DOI: 10.12945/j.jshd.2016.003.15
Extended Application of Self-Fabricated Covered Stents for Interventions in Adults with Congenital Heart Disease
Subeer K. Wadia, MD1*, Damien Kenny, MB, MD2, Wail Alkashkari, MB, MD3, Thomas Matella, RT(R)(CV)4, Clifford J. Kavinsky, MD, PhD5, Ziyad M. Hijazi, MD, MPH, MSCAI6
1 Ronald Reagan UCLA Medical Center, Internal Medicine, Los Angeles, California, USA
2 Division of Pediatric Cardiology, Our Lady’s Children’s Hospital, Dublin, Ireland
3 King Faisal Cardiac Center, Jeddah, Saudi Arabia
4 Rush University Medical Center, Chicago, Illinois, USA
5 Rush University Medical Center, Division of Cardiology, Chicago, Illinois, USA
6 Sidra Medical and Research Center, Doha, Qatar
Abstract
Background: Covered stents are widely used outside of the United States to treat adult patients with congenital heart disease. However, these stents have not been approved by the United States Food and Drug Administration (FDA). We describe our experience with large diameter, self-fabricated covered stents for patients with congenital heart disease.
Methods: We retrospectively examined results of adults with congenital heart disease who received a self-designed covered stent at our institution. We detailed our method of fabricating the covered stent and modifications in delivery to minimize traction or trauma against the outer covering of the stent.
Results: We implanted 25 fabricated covered stents in 21 patients. The cohort was divided into three disease groups: coarctation of the aorta [group (a), n = 17], pulmonary artery or right ventricle-to-pulmonary artery conduit stenosis [group (b), n = 3], and right-to-left shunting at site of prior anastomosis [group (c), n = 1]. In group (a), the mean systolic pressure gradient was reduced from 35.5 mm Hg to 5.7 mm Hg (p < 0.001). In group (b), the mean stenotic pressure gradient decreased from 37.7 to 8.7 mm Hg. The patient in group (c) had obliteration of shunting and improvement in symptoms.
Conclusions: Our self-fabricated covered stents were safe and provided effective gradient reduction or intraluminal continuity to treat individualized lesions related to congenital heart disease. Covered stents increase the therapeutic options for the interventional cardiologist and in some cases may be safer for the patient. There needs to be increased pressure from providers towards the FDA to approve these stents in the United States.
Cite this article as: Wadia SK, Kenny D, Alkashkari W, Matella T, Kavinsky CJ, Hijazi ZM. Extended Application of Self-Fabricated Covered Stents for Interventions in Adults with Congenital Heart Disease. Structural Heart Disease 2016;2(3):79-86. DOI: 10.12945/j.jshd.2016.003.15
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Original Research Articles
Journal of Structural Heart Disease, June 2016, Volume 2, Issue 3:79-86
DOI: 10.12945/j.jshd.2016.003.15
Extended Application of Self-Fabricated Covered Stents for Interventions in Adults with Congenital Heart Disease
Subeer K. Wadia, MD1*, Damien Kenny, MB, MD2, Wail Alkashkari, MB, MD3, Thomas Matella, RT(R)(CV)4, Clifford J. Kavinsky, MD, PhD5, Ziyad M. Hijazi, MD, MPH, MSCAI6
1 Ronald Reagan UCLA Medical Center, Internal Medicine, Los Angeles, California, USA
2 Division of Pediatric Cardiology, Our Lady’s Children’s Hospital, Dublin, Ireland
3 King Faisal Cardiac Center, Jeddah, Saudi Arabia
4 Rush University Medical Center, Chicago, Illinois, USA
5 Rush University Medical Center, Division of Cardiology, Chicago, Illinois, USA
6 Sidra Medical and Research Center, Doha, Qatar
Abstract
Background: Covered stents are widely used outside of the United States to treat adult patients with congenital heart disease. However, these stents have not been approved by the United States Food and Drug Administration (FDA). We describe our experience with large diameter, self-fabricated covered stents for patients with congenital heart disease.
Methods: We retrospectively examined results of adults with congenital heart disease who received a self-designed covered stent at our institution. We detailed our method of fabricating the covered stent and modifications in delivery to minimize traction or trauma against the outer covering of the stent.
Results: We implanted 25 fabricated covered stents in 21 patients. The cohort was divided into three disease groups: coarctation of the aorta [group (a), n = 17], pulmonary artery or right ventricle-to-pulmonary artery conduit stenosis [group (b), n = 3], and right-to-left shunting at site of prior anastomosis [group (c), n = 1]. In group (a), the mean systolic pressure gradient was reduced from 35.5 mm Hg to 5.7 mm Hg (p < 0.001). In group (b), the mean stenotic pressure gradient decreased from 37.7 to 8.7 mm Hg. The patient in group (c) had obliteration of shunting and improvement in symptoms.
Conclusions: Our self-fabricated covered stents were safe and provided effective gradient reduction or intraluminal continuity to treat individualized lesions related to congenital heart disease. Covered stents increase the therapeutic options for the interventional cardiologist and in some cases may be safer for the patient. There needs to be increased pressure from providers towards the FDA to approve these stents in the United States.
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Cite this article as: Wadia SK, Kenny D, Alkashkari W, Matella T, Kavinsky CJ, Hijazi ZM. Extended Application of Self-Fabricated Covered Stents for Interventions in Adults with Congenital Heart Disease. Structural Heart Disease 2016;2(3):79-86. DOI: 10.12945/j.jshd.2016.003.15
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