Closure of the patent ductus arteriosus with the amplatzer PDA device: immediate results of the international clinical trial.

The purpose of this article is to present the immediate and short-term results of the international registry of transcatheter closure of patent ductus arteriosus (PDA) using the Amplatzer duct occluder (ADO). Three hundred sixteen patients (221 females) in various centers with clinical and/or echocardiographic evidence of PDA underwent an attempt of catheter closure at a median age of 2.1 years and median weight of 10.7 kg. The median Qp/Qs ratio was 2.3, the median length of the PDA was 6.7 mm and the median diameter of the PDA at its narrowest point (usually the pulmonic end) was 3.8 mm. Immediately after closure and by angiography, the PDA was completely closed in 177/311 patients (56%) and within 24 hr the complete closure rate increased to 76% (235/308). Complications were encountered in 15 patients, including 1 major complication due to device embolization and subsequent death, 6 moderate complications, and 8 minor complications. The median fluoroscopy time was 12 min and the median total procedure time was 70 min. One hundred fourteen patients reached the 6-month follow-up. Color Doppler echocardiography demonstrated complete closure in 109 patients (94.6%). Thirty-eight patients reached the 1-year follow-up mark. There was complete closure in 100% of the patients as documented by color Doppler echocardiography. So far there has been no episodes of delayed device migration, endocarditis, thromboembolism, and wire fracture or device disruption. We conclude that the ADO is safe and effective in most patients with PDA up to a diameter of 10.6 mm. Further clinical trials are underway to assess its long-term safety and efficacy.

[Percutaneous balloon valvotomy in neonatal obstructive cardiopathy. II. Critical aortic valve stenosis]. / Valvotomía percutánea con balón en la cardiopatía obstructiva neonatal. Parte II: Estenosis valvular aórtica crítica.

Percutaneous balloon aortic valvotomy using one or more balloons in sequential approach was attempted in 11 non selected neonates with critical aortic valve stenosis. The procedure was complete in 9 (81%), and they represent the study group with a mean age of 19 days. Using a balloon/annulus ratio of 0.86, the transvalvar gradient decreased from 49 to 25 mmHg, and left ventricular systolic pressure fell from 112 mmHg to 96 mmHg (p < 0.01, respectively). Fifty-five percent (5/9) of the patients developed a new aortic regurgitation, only one with grade 3. The maximal instantaneous Doppler gradient recorded in 7 neonates before and after valvotomy dropped from 67 to 35 mmHg (p < 0.01); while the left ventricular shortening fraction increased from 15 to 31% (p < 0.01). The Doppler gradient was correlated with the left ventricular shortening fraction (r:0.72) and the aortic regurgitation with the balloon/annulus ratio (r:0.82). The balloon pulmonary valvotomy was unsuccessful in 2 neonates (22%), both with hypoplastic left ventricle, both of which died in the operating room. Echocardiographic features of reestenosis were not found in the follow-up period (14 +/- 10 months); only one patient may need a future surgical intervention because significant aortic insufficiency. The pulmonary balloon valvotomy is a safe and effective therapy that must be used as the first step in the management of neonates with critical aortic stenosis in absence of hypoplastic left ventricle.

[Percutaneous balloon valvotomy in neonatal obstructive cardiopathy. I: critical pulmonary valvular stenosis]. / Valvotomía percutánea con balón en la cardiopatía obstructiva neonatal. Parte I: estenosis valvular pulmonar crítica.

Percutaneous pulmonary balloon valvotomy using one balloon or more in sequential approach was attempted in 9 no selected neonates with critical pulmonary valve stenosis between March 1985 and October 1990 (mean age 10 + 8.6 days). The procedure was successful in seven of them (78%) in whom with a 1.22 + 0.2 balloon/annulus ratio the right ventricular systolic pressure decreased from 96 to 45 mmHg (p < 0.001), the transvalvular gradient from 65 to 23 mmHg (p < 0.001); and the systemic oxygen saturation increased from 69 to 86% (p < 0.001). In one patient the valve was not crossed. Two patients underwent surgery because unsuccessful balloon valvotomy result in the immediate and mid term period: hypoplastic right ventricle in one, and inferior vena cava thrombosis that prevent a second dilation in the other respectively. The mid term follow up showed a 62% (5/8) of successful result. Although the complex methodology and complications are not uncommon, the balloon pulmonary valvotomy is a safely and effective therapy for neonates with critical pulmonary stenosis.

Balloon pulmonary valvuloplasty in infants: a quantitative analysis of pulmonary valve-anulus-trunk structure.

OBJECTIVES: The present study was designed to establish possible predictors of unfavorable outcome in infants with pulmonary valve stenosis. BACKGROUND: Balloon pulmonary valvuloplasty is the treatment of choice for typical pulmonary valve stenosis. Patients with dysplastic valves may be less suitable candidates for this procedure because they have morphologic abnormalities of the complex valve-anulus-trunk that cause the obstructive phenomenon. METHODS: Twenty-five children (mean age +/- SD 1.1 +/- 0.7 years) with normal anulus diameter underwent balloon pulmonary valvuloplasty using a balloon/anulus ratio of 1.2 +/- 0.11. From the lateral view of a right ventricular angiogram, the following variables were quantified and scored: A, supravalvular narrowing; B, texture of the valve surface; C, diastolic deformity of the Valsalva sinuses; D, trunk/anulus ratio; E, systolic valve motion; and F, presence of a contrast jet. Paired t test, stepwise multivariate correlation with "dummy" variable methods were applied for both hemodynamic and valve-anulus-trunk determinations. RESULTS: The right ventricular-pulmonary artery gradient decreased from 66 +/- 21 (range 40 to 120) to 24 +/- 11 (range 10 to 50) mm Hg (p less than 0.001), whereas the right ventricular systolic pressure decreased from 89 +/- 20 (range 60 to 130) to 48 +/- 15 (range 30 to 80) mm Hg (p less than 0.001). Only variables A, B and D had significant influence in a percent reduction in right ventricular pulmonary artery gradient (R2 0.94, SEE 5.7; p less than 0.001). A score greater than or equal to greater than 4 obtained by adding the values from these three variables was correlated with poor outcome. CONCLUSIONS: These data show that there is an adequate relation between scores and outcome. We conclude that children less than 2 years old with pulmonary valve stenosis and a score greater than or equal to 4 should not be candidates for balloon pulmonary valvuloplasty.

Valoración ecocardiográfica de la relación comunicación interauricular/septum interauricular durante el cateterismo en niños con transposición completa de los grandes vasos / Echocardiographic evaluation of atrial septal defect/interatrial septum ratio during catheterization in infants with complete transposition of the great arteries

En 22 niños de 1 a 60 días (-x:22) con transposición completa de grandes vasos se valoró con ecocardiograma bidimensional en el postcateterismo inmediato la relación entre el tamaño de la comunicación interauricular (CIA) y la longitud del septum interauricular (SIA). En todos se comprobó incremento de la saturación, mayor del 80% del valor inicial, en ventrículo derecho y disminución franca del gradiente interauricular post-balón inmediato. Catorce niños con una relación CIA/SIA mayor de 0,20 (-x:0,24) tuvieron buena evolución clínica y fueron operados electivamente luego de los 6 meses con una relación prequirúrgica media de 0,16. Una relación menor de 0,12 (-x:0,07) se encontró en los 6 niños que requirieron un segundo cateterismo 11 a 33 días (-x:21) luego del primer procedimiento, con una relación media de 0,05. En conclusión; la relación CIA/SIA tendió a disminuir en función del tiempo, la evolución clínica tuvo relación directa con la relación CIA/SIA inicial y no hubo correlación entre saturación y gradiente interauricular inicial y evolución clínica. Pensamos que el cateterismo terapéutico debe realizarse con control ecocardiográfico no sólo para disminuir los riesgos sino para lograr una relación CIA/SIA mayor de 0,20 previniendo la necesidad de un segundo cateterismo terapéutico o de una cirugía temprana con mayor riesgo (AU)

Valoración ecocardiográfica de la relación comunicación interauricular/septum interauricular durante el cateterismo en niños con transposición completa de los grandes vasos / Echocardiographic evaluation of atrial septal defect/interatrial septum ratio during catheterization in infants with complete transposition of the great arteries

En 22 niños de 1 a 60 días (-x:22) con transposición completa de grandes vasos se valoró con ecocardiograma bidimensional en el postcateterismo inmediato la relación entre el tamaño de la comunicación interauricular (CIA) y la longitud del septum interauricular (SIA). En todos se comprobó incremento de la saturación, mayor del 80% del valor inicial, en ventrículo derecho y disminución franca del gradiente interauricular post-balón inmediato. Catorce niños con una relación CIA/SIA mayor de 0,20 (-x:0,24) tuvieron buena evolución clínica y fueron operados electivamente luego de los 6 meses con una relación prequirúrgica media de 0,16. Una relación menor de 0,12 (-x:0,07) se encontró en los 6 niños que requirieron un segundo cateterismo 11 a 33 días (-x:21) luego del primer procedimiento, con una relación media de 0,05. En conclusión; la relación CIA/SIA tendió a disminuir en función del tiempo, la evolución clínica tuvo relación directa con la relación CIA/SIA inicial y no hubo correlación entre saturación y gradiente interauricular inicial y evolución clínica. Pensamos que el cateterismo terapéutico debe realizarse con control ecocardiográfico no sólo para disminuir los riesgos sino para lograr una relación CIA/SIA mayor de 0,20 previniendo la necesidad de un segundo cateterismo terapéutico o de una cirugía temprana con mayor riesgo