BACKGROUND Balloon expandable intravascular stents have been used to support vessel walls in coronary and peripheral arteries in adults. The purpose of this study was to examine the efficacy and safety of these stents in the treatment of congenital heart disease. METHODS AND RESULTS Forty-five stents were placed in 30 patients, who were 0.2-30.2 years old (weight, 3.5-76 kg). Patients with areas of stenosis that were difficult to approach surgically were chosen. Stents were mounted over balloons and placed by standard catheterization techniques. Twenty-three patients had branch pulmonary artery stenosis. Thirty-six stents were placed successfully and had reduced pressure gradients from 50.6 +/- 24 to 15.9 +/- 13.4 mm Hg. Five patients had stents placed after atrial surgery: three in obstructed Fontan repairs, one at the superior vena cava-right atrial junction after sinus venous defect repair, and one at the site of a Glenn shunt. Atrial stents reduced pressure gradients from 9.8 +/- 8.2 to 2.0 +/- 2.6 mm Hg. One patient had a stent placed in the descending aorta after coarctation dilation, and the pressure gradient was reduced from 50 to 25 mm Hg. One patient had pulmonary vein dilation with stent placement. Two stents migrated at the time of placement; one required surgical removal, and one was anchored in place by balloon dilation. One patient died within 24 hours of catheterization because of thrombus obstruction of the Fontan repair. Nine patients have undergone recatheterization. All stented vessels have remained at the same caliber as at original stent placement. CONCLUSIONS We conclude that balloon expandable stents are useful in selected postoperative stenoses in congenital heart disease.

The adverse effects of small inflow, outflow, and/or cavity size of the left ventricle are cumulative. The accuracy of prediction of outcome based only on preoperative anatomy indicates that adequacy of valvotomy is not generally a limiting factor for survival in this group of patients. It is possible to identify subjects whose chance of survival is better after a Norwood procedure rather than valvotomy, even if left ventricular volume is not critically small.

BACKGROUND Balloon-expandable stents (Johnson and Johnson Interventional Systems) have been in use for congenital heart disease since late 1989. They have made possible treatment in previously untreatable branch pulmonary artery stenoses and systemic venous stenosis. The purpose of this report is to detail the results and intermediate-term follow-up of stents used for treatment of congenital heart disease. METHODS AND RESULTS Eighty-five patients underwent placement of 121 stents in Houston and Boston. Fifty-eight patients had stents put in pulmonary arteries, nine had stents in conduits or outflow tracts, and 21 had stents in venous stenoses or narrowed Fontan anastomoses. (Three patients had stents in two locations.) These stent procedures resulted in gradient reduction from 55.2 +/- 33.3 to 14.2 +/- 13.5 mm Hg in pulmonary arteries, from 41.4 +/- 26.0 to 20.7 +/- 17.0 mm Hg in conduits or outflow tracts, and from 9.8 +/- 6.9 to 2.4 +/- 3.1 mm Hg in venous stenoses or Fontan anastomoses. Diameter of narrowings increased from 4.6 +/- 2.3 to 11.3 +/- 3.2 mm in the pulmonary artery, from 8.8 +/- 3.6 to 12.7 +/- 2.6 in conduits, and from 3.8 +/- 2.9 to 11.3 +/- 2.8 in venous stenoses. Follow-up has shown stent fracture in one patient, restenosis in one, and sudden death in one. Recatheterization has been done in 38 patients an average of 8.6 months after stent installation. Compared with immediately postimplant data, there was no significant change in luminal diameter or pressure gradient. Redilation was performed in 14 patients (17 stents) 1 week to 24 months after implantation (mean, 10.2 months), with a small but significant increase in stenosis diameter. CONCLUSIONS We conclude that stent treatment of vascular stenoses in congenital heart disease retains efficacy at medium-term follow-up and offers a much-improved outlook for patients with these lesions.

Baffle fenestration is associated with low mortality, significantly less pleural effusion, and significantly shorter hospitalization among high-risk patients having a modified Fontan operation.

The 8-year survival rate after dilation was 95% with 50% of patients free of repeat intervention. Factors that increased the risk for repeat intervention included symmetrically thin or thick aortic valve leaflets, regurgitation grade > or = 3 after dilation and a high residual gradient after dilation. The incidence of repeat intervention after dilation was high owing to its palliative nature.

Two hundred eighteen balloon angioplasty procedures were performed in 135 patients with branch pulmonary artery stenoses from June 1984 to February 1989. Arteries were dilated in patients with tetralogy of Fallot (n = 49), tetralogy of Fallot/pulmonary atresia (n = 64), isolated peripheral pulmonary artery stenoses (n = 58) and "other" lesions (the majority had truncus arteriosus or single ventricle and surgically induced pulmonary artery stenoses (n = 47). Mean age at dilation was 6.6 +/- 6.3 years (range 1 month to 38.5 years). The mean diameter of the lesion increased from 3.8 +/- 1.7 to 5.5 +/- 2.1 mm with dilation (p = 0.001). The overall success rate was 58% (127 of 218 dilations), assessed by the following criteria: an increase greater than or equal to 50% of predilation diameter, an increase greater than 20% in flow to the affected lung or a decrease greater than 20% in systolic right ventricular to aortic pressure ratio. Success did not correlate with patient age. Mean balloon to artery ratio was higher in successful (4.2) than in failed (3.0) angioplasty procedures (p = 0.0001). There were four early deaths: two of the patients had pulmonary artery rupture with angioplasty performed less than 1 month after pulmonary artery surgery. An aneurysm occurred in 11 arteries and transient pulmonary edema in four patients. At angiography performed a mean of 10 months (range 1 to 54) after dilation, the mean diameter of 57 arteries was unchanged (5.5 versus 5.4 mm). However, 5 of 32 initially successfully dilated vessels had returned to predilation size as a result of restenosis.(ABSTRACT TRUNCATED AT 250 WORDS)

Transcatheter closure of a coronary artery fistula was undertaken in nine patients. There were three fistulas from the left circumflex coronary artery to the coronary sinus, three from the left anterior descending coronary artery to the right ventricular apex, two from the right coronary artery to the superior vena cava/right atrial junction and one fistula from the left circumflex artery to the pulmonary artery. The fistula was closed with Gianturco coils in six patients, a double-umbrella device in two and a combination of an umbrella and coils in one patient. All fistulas are completely occluded. Complications consisted of migration of two coils, one of which was retrieved, and a transient junctional tachycardia in one patient. In an additional three patients with multiple coronary artery fistulas, transcatheter occlusion was not attempted.

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