Intravascular stents in congenital heart disease

Short- and long-term results from a large single-center experience

Kenneth M. Shaffer, Charles E. Mullins, Ronald G. Grifka, Martin P. O'Laughlin, William McMahon, Frank Ing, Michael R. Nihill

Research output: Contribution to journalArticle

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Abstract

Objectives. This report describes the results of the Food and Drug Administration's phase 1 and 2 clinical trials of intravascular stents at Texas Children's Hospital. Background. Since the late 1980s, intravascular stent implantation for the treatment of arterial and venous stenoses in congenital heart disease has been highly successful. Methods. Stents were placed in postoperative pulmonary artery (PA) stenoses, congenital PA stenoses or stenoses of systemic veins/venous anastomoses. Prospective collection of data according to protocol was done before intervention, after stent implantation and at follow-up catheterization. Results. At stent implantation, pressure gradients decreased significantly in all three groups (mean ± SD): from 46 ± 25 to 10 ± 13 mm Hg in postoperative PA stenoses (p < 0.001); from 71 ± 45 to 15 ± 21 mm Hg in congenital PA stenoses (p < 0.001); and from 7 ± 6 to 1 ± 2 mm Hg in stenoses of systemic veins/venous anastomoses stenoses (p < 0.001). Vessel diameters markedly increased: from 6 ± 3 to 12 ± 3 mm in pestoperative PA stenoses (p < 0.001); from 3 ± 1 to 9 ± 1 mm in congenital PA stenoses (p < 0.001); and from 3 ± 4 to 12 ± 4 mm in stenoses of systemic veins/venous anastomoses (p < 0.001). In the postoperative and congenital PA stenoses groups, right ventricular pressure decreased (right ventricular pressure indexed to femoral artery pressure ratio): from 0.63 ± 0.2 to 0.41 ± 0.02 (p < 0.001) and from 0.71 ± 03 to 0.55 ± 0.35 (p = 0.04), respectively. Perfusion to a single affected lung increased from 31 ± 17% to 46 ± 14% (p < 0.001). On recatheterization (mean 14 months), results varied minimally. Repeat angioplasty of residual stent stenoses was safe and effective. Complications included four early patients with stent migration, three with stent thrombosis and two deaths. There were no late complications. Significant restenosis occurred in only three patients. Conclusions. Intravascular stents for the treatment of vascular stenoses in congenital heart disease provide excellent immediate and long- term results.

Original languageEnglish (US)
Pages (from-to)661-667
Number of pages7
JournalJournal of the American College of Cardiology
Volume31
Issue number3
DOIs
StatePublished - Mar 1 1998
Externally publishedYes

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Stents
Heart Diseases
Pathologic Constriction
Veins
Ventricular Pressure
Pressure
Clinical Trials, Phase I
United States Food and Drug Administration
Femoral Artery
Pulmonary Artery Stenosis
Angioplasty
Catheterization
Blood Vessels
Thrombosis
Perfusion
Lung
Therapeutics

ASJC Scopus subject areas

  • Nursing(all)

Cite this

Intravascular stents in congenital heart disease : Short- and long-term results from a large single-center experience. / Shaffer, Kenneth M.; Mullins, Charles E.; Grifka, Ronald G.; O'Laughlin, Martin P.; McMahon, William; Ing, Frank; Nihill, Michael R.

In: Journal of the American College of Cardiology, Vol. 31, No. 3, 01.03.1998, p. 661-667.

Research output: Contribution to journalArticle

Shaffer, Kenneth M. ; Mullins, Charles E. ; Grifka, Ronald G. ; O'Laughlin, Martin P. ; McMahon, William ; Ing, Frank ; Nihill, Michael R. / Intravascular stents in congenital heart disease : Short- and long-term results from a large single-center experience. In: Journal of the American College of Cardiology. 1998 ; Vol. 31, No. 3. pp. 661-667.
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abstract = "Objectives. This report describes the results of the Food and Drug Administration's phase 1 and 2 clinical trials of intravascular stents at Texas Children's Hospital. Background. Since the late 1980s, intravascular stent implantation for the treatment of arterial and venous stenoses in congenital heart disease has been highly successful. Methods. Stents were placed in postoperative pulmonary artery (PA) stenoses, congenital PA stenoses or stenoses of systemic veins/venous anastomoses. Prospective collection of data according to protocol was done before intervention, after stent implantation and at follow-up catheterization. Results. At stent implantation, pressure gradients decreased significantly in all three groups (mean ± SD): from 46 ± 25 to 10 ± 13 mm Hg in postoperative PA stenoses (p < 0.001); from 71 ± 45 to 15 ± 21 mm Hg in congenital PA stenoses (p < 0.001); and from 7 ± 6 to 1 ± 2 mm Hg in stenoses of systemic veins/venous anastomoses stenoses (p < 0.001). Vessel diameters markedly increased: from 6 ± 3 to 12 ± 3 mm in pestoperative PA stenoses (p < 0.001); from 3 ± 1 to 9 ± 1 mm in congenital PA stenoses (p < 0.001); and from 3 ± 4 to 12 ± 4 mm in stenoses of systemic veins/venous anastomoses (p < 0.001). In the postoperative and congenital PA stenoses groups, right ventricular pressure decreased (right ventricular pressure indexed to femoral artery pressure ratio): from 0.63 ± 0.2 to 0.41 ± 0.02 (p < 0.001) and from 0.71 ± 03 to 0.55 ± 0.35 (p = 0.04), respectively. Perfusion to a single affected lung increased from 31 ± 17{\%} to 46 ± 14{\%} (p < 0.001). On recatheterization (mean 14 months), results varied minimally. Repeat angioplasty of residual stent stenoses was safe and effective. Complications included four early patients with stent migration, three with stent thrombosis and two deaths. There were no late complications. Significant restenosis occurred in only three patients. Conclusions. Intravascular stents for the treatment of vascular stenoses in congenital heart disease provide excellent immediate and long- term results.",
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AU - Shaffer, Kenneth M.

AU - Mullins, Charles E.

AU - Grifka, Ronald G.

AU - O'Laughlin, Martin P.

AU - McMahon, William

AU - Ing, Frank

AU - Nihill, Michael R.

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N2 - Objectives. This report describes the results of the Food and Drug Administration's phase 1 and 2 clinical trials of intravascular stents at Texas Children's Hospital. Background. Since the late 1980s, intravascular stent implantation for the treatment of arterial and venous stenoses in congenital heart disease has been highly successful. Methods. Stents were placed in postoperative pulmonary artery (PA) stenoses, congenital PA stenoses or stenoses of systemic veins/venous anastomoses. Prospective collection of data according to protocol was done before intervention, after stent implantation and at follow-up catheterization. Results. At stent implantation, pressure gradients decreased significantly in all three groups (mean ± SD): from 46 ± 25 to 10 ± 13 mm Hg in postoperative PA stenoses (p < 0.001); from 71 ± 45 to 15 ± 21 mm Hg in congenital PA stenoses (p < 0.001); and from 7 ± 6 to 1 ± 2 mm Hg in stenoses of systemic veins/venous anastomoses stenoses (p < 0.001). Vessel diameters markedly increased: from 6 ± 3 to 12 ± 3 mm in pestoperative PA stenoses (p < 0.001); from 3 ± 1 to 9 ± 1 mm in congenital PA stenoses (p < 0.001); and from 3 ± 4 to 12 ± 4 mm in stenoses of systemic veins/venous anastomoses (p < 0.001). In the postoperative and congenital PA stenoses groups, right ventricular pressure decreased (right ventricular pressure indexed to femoral artery pressure ratio): from 0.63 ± 0.2 to 0.41 ± 0.02 (p < 0.001) and from 0.71 ± 03 to 0.55 ± 0.35 (p = 0.04), respectively. Perfusion to a single affected lung increased from 31 ± 17% to 46 ± 14% (p < 0.001). On recatheterization (mean 14 months), results varied minimally. Repeat angioplasty of residual stent stenoses was safe and effective. Complications included four early patients with stent migration, three with stent thrombosis and two deaths. There were no late complications. Significant restenosis occurred in only three patients. Conclusions. Intravascular stents for the treatment of vascular stenoses in congenital heart disease provide excellent immediate and long- term results.

AB - Objectives. This report describes the results of the Food and Drug Administration's phase 1 and 2 clinical trials of intravascular stents at Texas Children's Hospital. Background. Since the late 1980s, intravascular stent implantation for the treatment of arterial and venous stenoses in congenital heart disease has been highly successful. Methods. Stents were placed in postoperative pulmonary artery (PA) stenoses, congenital PA stenoses or stenoses of systemic veins/venous anastomoses. Prospective collection of data according to protocol was done before intervention, after stent implantation and at follow-up catheterization. Results. At stent implantation, pressure gradients decreased significantly in all three groups (mean ± SD): from 46 ± 25 to 10 ± 13 mm Hg in postoperative PA stenoses (p < 0.001); from 71 ± 45 to 15 ± 21 mm Hg in congenital PA stenoses (p < 0.001); and from 7 ± 6 to 1 ± 2 mm Hg in stenoses of systemic veins/venous anastomoses stenoses (p < 0.001). Vessel diameters markedly increased: from 6 ± 3 to 12 ± 3 mm in pestoperative PA stenoses (p < 0.001); from 3 ± 1 to 9 ± 1 mm in congenital PA stenoses (p < 0.001); and from 3 ± 4 to 12 ± 4 mm in stenoses of systemic veins/venous anastomoses (p < 0.001). In the postoperative and congenital PA stenoses groups, right ventricular pressure decreased (right ventricular pressure indexed to femoral artery pressure ratio): from 0.63 ± 0.2 to 0.41 ± 0.02 (p < 0.001) and from 0.71 ± 03 to 0.55 ± 0.35 (p = 0.04), respectively. Perfusion to a single affected lung increased from 31 ± 17% to 46 ± 14% (p < 0.001). On recatheterization (mean 14 months), results varied minimally. Repeat angioplasty of residual stent stenoses was safe and effective. Complications included four early patients with stent migration, three with stent thrombosis and two deaths. There were no late complications. Significant restenosis occurred in only three patients. Conclusions. Intravascular stents for the treatment of vascular stenoses in congenital heart disease provide excellent immediate and long- term results.

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