(Acta Paediatr Jpn 1992; 34: 433
- 440)
Balloon Valvuloplasty for Congenital Aortic Valve Stenosis in an Infant and Children Kuninobu Saiki, M.D., Hirohisa Kato, M.D., Kazushige Suzuki, M.D., Osamu Inoue, M.D., On Toyoda, M.D., Junichi Takagi, M.D., Noboru Sato, M.D., Nobutoshi Ohara, M.D., Teiji Akagi, M.D., Masahiro Ishii, M.D., Takumi Miyake, M.D., Tetsu Sugimura, M.D., Yasuki Maeno, M.D., Kanoko Hashino, M.D. and Tsuyoshi Fukuda, M.D. Department of Pediatrics, Kuritme University, School of Medicine, Kururne. Japan
Percutaneous balloon aortic valvuloplasty (BAV) was performed in 14 patients, including one critically ill infant with congenital valvular aortic stenosis (AS). BAV was effective in 13 patients (except the infant). The peak systolic pressure gradient between the left ventricle (LV) and the ascending aorta decreased from 76.6 t 21.6 to 29.5 -t 15.3 mmHg (P< 0.001). Follow-up cardiac catheterization was performed for eight patients between 1 and 3 years (1.6 k 1.1 years) after BAV. Restenosis was found in only one patient, and the efficacy of BAV continued significantly. Aortic regurgitation developed or increased in severity in 5 of 13 children immediately after BAV. Any other severe complication was not observed. Dilatation by BAV was not sufficient for the infant with critical AS, and acute myocardial infarction (AMI) in the lateral wall of the LV occurred during the BAV procedure. The infant died 3 days after the procedure due to AMI. It was concluded that the retrograde double balloon technique was superior to the retrograde single balloon technique. In two cases, the single balloon technique was ineffective because it was impossible to fix the balloon at the aortic annulus. However, the double balloon technique was effective in every patient. BAV is effective for AS in children, and an optional repeat trial may enable BAV to be the first choice for AS. Although BAV may be effective for neonates and infants with critical AS as an emergency treatment, much attention must be paid during the procedure. Key Words Balloon aortic valvuloplasty, Congenital aortic valve stenosis, Critical aortic valve stenosis, Interventional cardiology, Surgical valvotomy
Introduction
be progressive and may cause sudden death in some instances. A case with severe neonatal critical AS is usually fatal. In recent years, balloon dilatation has been employed for various stenotic lesions in place of surgery. Balloon pulmonary valvuloplasty and balloon angioplasty for recoarctation of the aorta are widely used [ 11. However balloon aortic valvuloplasty new procedure, and its (BAV) for AS is a efficacy and safety have not been fully discussed ~~
Congenital aortic valve stenosis (AS) is an important congenital heart disease because it may Received September 19, 1991 Revised February 4, 1992 Accepted February 7, 1992 Correspondence address: Kuninobu Saiki, M.D., Department of Pediatrics, Kurume University, School of Medicine, 67 Asahi-machi, Kurume 830, Japan.
434 (50) Saiki et al. [2-191. This report describes 14 consecutive patients with AS who underwent BAV, and evaluates the efficacy of BAV.
Patients and Methods From October 1985 to June 1991, BAV was performed for 14 patients, including one infant aged 51 days with critical AS (Table 1). This infant was critically ill with severe congestive heart failure, dyspnea, weak pulse and decreased ejection fraction of the left ventricle (LV) on echocardiography (ECHO). BAV was performed as an emergency procedure. The other 13 patients underwent non-emergency elective BAV. This non-emergency group included three patients with restenosis after prior surgical aortic valvotomy. One patient had been associated with a small ventricular septal defect, while others had no associated cardiac lesion. At the time of BAV, the average age was 8.0 k 6.1 years (range 51 days to 17 years), and the average weight was 30.8 k 20.6 kg (range 4-60 kg). Four patients, including one critically ill infant, had unicommisural aortic valve, and the other 10 patients had bicommisural aortic valve evaluated by aortography, ECHO or surgical findings. The infant with critical AS had no hypoplastic LV. The infant had an annulus diameter of 9 mm and left ventricular enddiastolic dimension of 33 mm on ECHO. At
present we perform BAV according to the criteria shown in Table 2. However, during the past 3 years BAV was attempted for all patients who would have required surgery without any exception. A retrograde single balloon technique was performed for nine patients, including the one critically ill infant, while a retrograde double balloon technique was performed for three patients. These two techniques were used for two patients (Fig. 1) Before the cardiac catheterization, we performed detailed two-dimensional, M-mode, and Doppler ECHO using an Aloka SSD-730 or SSD870. With a 5 MHz transducer, the morphology and movement of the aortic valve, the annulus diameter, wall motion and wall thickness of the LV were evaluated. With a 2 MHz transducer, we evaluated the pressure gradient between the LV and the ascending aorta ( A - Ao) and also the degree of aortic regurgitation (AR). From the ECHO results, we determined the patient’s suitability for BAV and prepared the appropriate size of balloon catheters. Two-dimensional echography (2-D) on the bilateral femoral arteries was used to assess any adverse arterial damage or hemorrhage caused by BAV. All patients took 5 mg/kg per day of aspirin orally from 3 days before BAV to 2 weeks after BAV to prevent thrombosis. We put patients under general anaesthesia with 1-2 mg/kg ketamine hydrochloride i.v.
Table 1. Patients list Patient (sex)
Age (years)
T. K. (M) 10 S . T. (M) 5 K. M. (M) 2 T. 0. (M) 12 H. S. (M) 17
Weight (kg)
Height (cm)
BSA (m’)
Annulus (mm)
Balloon (mm)
Ball/Ann
Cusps
(%)
Operation before BAV
Associated lesions
95 3 88 3 96 13 92 3 25 130 22 91 3 55 165 23 I00 2 + 99 H. S . (F) 7 19 113 0.76 23 99 3 VSD S. A. (M) 15 60 166 1.70 25 98 3 T. U. (M) 4 15 104 0.66 17 s 15 88 3 100 7 t H. 1. (M) 10 29 132 1.00 IS s 18 d 8t12 92 56 2 T. 0.(M)* 51 days 4.3 55 0.26 9 s 5 S. H. (F) 17 46 155 1.40 22 d 1 3 t 15 I04 2 + Y. A. (M) 5 18 107 0.14 16 s 15 94 3 H. N. (M) 15 166 73 1.80 24 s 23 96 3 Y . S. (M) 1 9.6 15 0.47 I2 s 8 67 3 *Infant with critical aortic valve stenosis; Ball: balloon size; Ann: annulus size; BSA, body surface area; s. single balloon technique: d, double balloon technique; VSD, ventricular septal defect. 22
14 15
121 101
0.85 0.62 0.75 0.95 1.62
21 17
s 20 s 15 s 12 5 20 s 23 d 1 0 t 18 d lot18 d 15+15
-
Acta Paediatr Jpn
Balloon aortic valvuloplasty ( 5 1) 435
1
Table 2. Indications of balloon aortic valvuloplasty Pressure gradient between the left ventricle and the aorta estimated by cardiac catheterization 2 50 mmHg Severely symptomatic patients (e.g. syncope, chest pain, fatigue, dyspnea, cyanosis etc.) Uncontrollable severe congestive heart failure *Balloon aortic valvuloplasty may be the first choice instead of operation for: (i) female patients; (ii) restenosis after surgical aortic valvotomy: and (iii) patients with other severe disease (hematological disease, metabolic disease etc.).
Fig. 1: Balloon aortic valvuloplasty (BAV). (a): retrograde single balloon technique; (b): retrograde double balloon technique.
before the BAV procedure. First, the routine cardiac catheterization was performed. The catheters were entered in the femoral artery and vein percutaneously. Intravenous administration of 100 unitslkg heparin was followed by an additional 50 unitslkg every subsequent h. Catheters were inserted into the LV retrogradely. When it was difficult to insert a catheter into the LV, a Gensini or Amplatz catheter was used with a guidewire. After the evaluation of the pressure gradient between the LV and the A - Ao, we performed an aortography to assess the presence of AR and to estimate the aortic annulus diameter. In the single balloon technique, we used a balloon catheter with a size of almost 90- 10090of the aortic annulus diameter.
Vol. 34 No. 4 August 1992
d2
I_ Circ
-
x (di + d2)
2
+
24-
Fig. 2: Scott-B-Yeager’s formula. This formula was used with the double balloon technique to decide the diameters of the two balloon catheters.
In the double balloon technique, the size of balloon catheters was selected using the Scott-BYeager formula (Fig. 2). The balloon catheter was inserted over a guidewire retrogradely. Just before inflating the balloon, we injected 0.01 mg/kg atropine sulfate to prevent bradycardia. The balloon was positioned over the stenotic valve and inflated sequentially 3-4 times, with the inflation being held for 5-10 sec until the ‘waist’ disappeared. Afterwards we again evaluated the pressure gradient between the LV and the A - Ao and assessed the degree of AR. Follow-up ECHO was performed at 1 day, 2 weeks, 1 month, 3 months and 6 months after BAV in order to evaluate the efficacy of BAV, such as pressure gradient, AR, and so on. Then follow-up ECHO was performed every 3 or 4 months. Follow-up cardiac catheterization was performed 1.6 -t 1.1 years after BAV in eight patients. Additionally we investigated to determine femoral arterial damage using 2-D immediately after BAV.
Results The results of BAV for the 13 children are reported separately to the result of BAV for the infant with critical AS. The overall results of BAV for the children were effective. The peak systolic pressure gradient between the LV and the A - Ao decreased from 76.6 f 21.6 to 29.5 f 15.3 mmHg immediately after BAV ( P < 0.001). Follow-up catheterization was performed in eight patients between 1 and 3 years (1.6 k 1.1 years) after
436 ( 5 2 ) Saiki et al.
100
la PRE
m
IMM
3
1
5
Time (years)
Lo
0 150
PRE
IMM
PRE
Time
IMM
Follow-up
Time
Fig. 3: Peak systolic pressure gradient between the left ventricle and the ascending aorta estimated by cardiac catheterization. PRE, before BAV; IMM, immediately after BAV. (a) In 13 children, the eficacy of BAV was continuing except in one case that showed restenosis. (b) In the 13 children with AS, the pressure gradient significantly decreased from 76.6 ? 21.6 to 29.5 k 15.3 mmHg immediately after BAV (P < 0.001). (c) Follow-up catheterization was performed in eight cases 1.6 t 1.1 years after BAV. The efficacy of BAV was continuing (P
- 440)
Balloon Valvuloplasty for Congenital Aortic Valve Stenosis in an Infant and Children Kuninobu Saiki, M.D., Hirohisa Kato, M.D., Kazushige Suzuki, M.D., Osamu Inoue, M.D., On Toyoda, M.D., Junichi Takagi, M.D., Noboru Sato, M.D., Nobutoshi Ohara, M.D., Teiji Akagi, M.D., Masahiro Ishii, M.D., Takumi Miyake, M.D., Tetsu Sugimura, M.D., Yasuki Maeno, M.D., Kanoko Hashino, M.D. and Tsuyoshi Fukuda, M.D. Department of Pediatrics, Kuritme University, School of Medicine, Kururne. Japan
Percutaneous balloon aortic valvuloplasty (BAV) was performed in 14 patients, including one critically ill infant with congenital valvular aortic stenosis (AS). BAV was effective in 13 patients (except the infant). The peak systolic pressure gradient between the left ventricle (LV) and the ascending aorta decreased from 76.6 t 21.6 to 29.5 -t 15.3 mmHg (P< 0.001). Follow-up cardiac catheterization was performed for eight patients between 1 and 3 years (1.6 k 1.1 years) after BAV. Restenosis was found in only one patient, and the efficacy of BAV continued significantly. Aortic regurgitation developed or increased in severity in 5 of 13 children immediately after BAV. Any other severe complication was not observed. Dilatation by BAV was not sufficient for the infant with critical AS, and acute myocardial infarction (AMI) in the lateral wall of the LV occurred during the BAV procedure. The infant died 3 days after the procedure due to AMI. It was concluded that the retrograde double balloon technique was superior to the retrograde single balloon technique. In two cases, the single balloon technique was ineffective because it was impossible to fix the balloon at the aortic annulus. However, the double balloon technique was effective in every patient. BAV is effective for AS in children, and an optional repeat trial may enable BAV to be the first choice for AS. Although BAV may be effective for neonates and infants with critical AS as an emergency treatment, much attention must be paid during the procedure. Key Words Balloon aortic valvuloplasty, Congenital aortic valve stenosis, Critical aortic valve stenosis, Interventional cardiology, Surgical valvotomy
Introduction
be progressive and may cause sudden death in some instances. A case with severe neonatal critical AS is usually fatal. In recent years, balloon dilatation has been employed for various stenotic lesions in place of surgery. Balloon pulmonary valvuloplasty and balloon angioplasty for recoarctation of the aorta are widely used [ 11. However balloon aortic valvuloplasty new procedure, and its (BAV) for AS is a efficacy and safety have not been fully discussed ~~
Congenital aortic valve stenosis (AS) is an important congenital heart disease because it may Received September 19, 1991 Revised February 4, 1992 Accepted February 7, 1992 Correspondence address: Kuninobu Saiki, M.D., Department of Pediatrics, Kurume University, School of Medicine, 67 Asahi-machi, Kurume 830, Japan.
434 (50) Saiki et al. [2-191. This report describes 14 consecutive patients with AS who underwent BAV, and evaluates the efficacy of BAV.
Patients and Methods From October 1985 to June 1991, BAV was performed for 14 patients, including one infant aged 51 days with critical AS (Table 1). This infant was critically ill with severe congestive heart failure, dyspnea, weak pulse and decreased ejection fraction of the left ventricle (LV) on echocardiography (ECHO). BAV was performed as an emergency procedure. The other 13 patients underwent non-emergency elective BAV. This non-emergency group included three patients with restenosis after prior surgical aortic valvotomy. One patient had been associated with a small ventricular septal defect, while others had no associated cardiac lesion. At the time of BAV, the average age was 8.0 k 6.1 years (range 51 days to 17 years), and the average weight was 30.8 k 20.6 kg (range 4-60 kg). Four patients, including one critically ill infant, had unicommisural aortic valve, and the other 10 patients had bicommisural aortic valve evaluated by aortography, ECHO or surgical findings. The infant with critical AS had no hypoplastic LV. The infant had an annulus diameter of 9 mm and left ventricular enddiastolic dimension of 33 mm on ECHO. At
present we perform BAV according to the criteria shown in Table 2. However, during the past 3 years BAV was attempted for all patients who would have required surgery without any exception. A retrograde single balloon technique was performed for nine patients, including the one critically ill infant, while a retrograde double balloon technique was performed for three patients. These two techniques were used for two patients (Fig. 1) Before the cardiac catheterization, we performed detailed two-dimensional, M-mode, and Doppler ECHO using an Aloka SSD-730 or SSD870. With a 5 MHz transducer, the morphology and movement of the aortic valve, the annulus diameter, wall motion and wall thickness of the LV were evaluated. With a 2 MHz transducer, we evaluated the pressure gradient between the LV and the ascending aorta ( A - Ao) and also the degree of aortic regurgitation (AR). From the ECHO results, we determined the patient’s suitability for BAV and prepared the appropriate size of balloon catheters. Two-dimensional echography (2-D) on the bilateral femoral arteries was used to assess any adverse arterial damage or hemorrhage caused by BAV. All patients took 5 mg/kg per day of aspirin orally from 3 days before BAV to 2 weeks after BAV to prevent thrombosis. We put patients under general anaesthesia with 1-2 mg/kg ketamine hydrochloride i.v.
Table 1. Patients list Patient (sex)
Age (years)
T. K. (M) 10 S . T. (M) 5 K. M. (M) 2 T. 0. (M) 12 H. S. (M) 17
Weight (kg)
Height (cm)
BSA (m’)
Annulus (mm)
Balloon (mm)
Ball/Ann
Cusps
(%)
Operation before BAV
Associated lesions
95 3 88 3 96 13 92 3 25 130 22 91 3 55 165 23 I00 2 + 99 H. S . (F) 7 19 113 0.76 23 99 3 VSD S. A. (M) 15 60 166 1.70 25 98 3 T. U. (M) 4 15 104 0.66 17 s 15 88 3 100 7 t H. 1. (M) 10 29 132 1.00 IS s 18 d 8t12 92 56 2 T. 0.(M)* 51 days 4.3 55 0.26 9 s 5 S. H. (F) 17 46 155 1.40 22 d 1 3 t 15 I04 2 + Y. A. (M) 5 18 107 0.14 16 s 15 94 3 H. N. (M) 15 166 73 1.80 24 s 23 96 3 Y . S. (M) 1 9.6 15 0.47 I2 s 8 67 3 *Infant with critical aortic valve stenosis; Ball: balloon size; Ann: annulus size; BSA, body surface area; s. single balloon technique: d, double balloon technique; VSD, ventricular septal defect. 22
14 15
121 101
0.85 0.62 0.75 0.95 1.62
21 17
s 20 s 15 s 12 5 20 s 23 d 1 0 t 18 d lot18 d 15+15
-
Acta Paediatr Jpn
Balloon aortic valvuloplasty ( 5 1) 435
1
Table 2. Indications of balloon aortic valvuloplasty Pressure gradient between the left ventricle and the aorta estimated by cardiac catheterization 2 50 mmHg Severely symptomatic patients (e.g. syncope, chest pain, fatigue, dyspnea, cyanosis etc.) Uncontrollable severe congestive heart failure *Balloon aortic valvuloplasty may be the first choice instead of operation for: (i) female patients; (ii) restenosis after surgical aortic valvotomy: and (iii) patients with other severe disease (hematological disease, metabolic disease etc.).
Fig. 1: Balloon aortic valvuloplasty (BAV). (a): retrograde single balloon technique; (b): retrograde double balloon technique.
before the BAV procedure. First, the routine cardiac catheterization was performed. The catheters were entered in the femoral artery and vein percutaneously. Intravenous administration of 100 unitslkg heparin was followed by an additional 50 unitslkg every subsequent h. Catheters were inserted into the LV retrogradely. When it was difficult to insert a catheter into the LV, a Gensini or Amplatz catheter was used with a guidewire. After the evaluation of the pressure gradient between the LV and the A - Ao, we performed an aortography to assess the presence of AR and to estimate the aortic annulus diameter. In the single balloon technique, we used a balloon catheter with a size of almost 90- 10090of the aortic annulus diameter.
Vol. 34 No. 4 August 1992
d2
I_ Circ
-
x (di + d2)
2
+
24-
Fig. 2: Scott-B-Yeager’s formula. This formula was used with the double balloon technique to decide the diameters of the two balloon catheters.
In the double balloon technique, the size of balloon catheters was selected using the Scott-BYeager formula (Fig. 2). The balloon catheter was inserted over a guidewire retrogradely. Just before inflating the balloon, we injected 0.01 mg/kg atropine sulfate to prevent bradycardia. The balloon was positioned over the stenotic valve and inflated sequentially 3-4 times, with the inflation being held for 5-10 sec until the ‘waist’ disappeared. Afterwards we again evaluated the pressure gradient between the LV and the A - Ao and assessed the degree of AR. Follow-up ECHO was performed at 1 day, 2 weeks, 1 month, 3 months and 6 months after BAV in order to evaluate the efficacy of BAV, such as pressure gradient, AR, and so on. Then follow-up ECHO was performed every 3 or 4 months. Follow-up cardiac catheterization was performed 1.6 -t 1.1 years after BAV in eight patients. Additionally we investigated to determine femoral arterial damage using 2-D immediately after BAV.
Results The results of BAV for the 13 children are reported separately to the result of BAV for the infant with critical AS. The overall results of BAV for the children were effective. The peak systolic pressure gradient between the LV and the A - Ao decreased from 76.6 f 21.6 to 29.5 f 15.3 mmHg immediately after BAV ( P < 0.001). Follow-up catheterization was performed in eight patients between 1 and 3 years (1.6 k 1.1 years) after
436 ( 5 2 ) Saiki et al.
100
la PRE
m
IMM
3
1
5
Time (years)
Lo
0 150
PRE
IMM
PRE
Time
IMM
Follow-up
Time
Fig. 3: Peak systolic pressure gradient between the left ventricle and the ascending aorta estimated by cardiac catheterization. PRE, before BAV; IMM, immediately after BAV. (a) In 13 children, the eficacy of BAV was continuing except in one case that showed restenosis. (b) In the 13 children with AS, the pressure gradient significantly decreased from 76.6 ? 21.6 to 29.5 k 15.3 mmHg immediately after BAV (P < 0.001). (c) Follow-up catheterization was performed in eight cases 1.6 t 1.1 years after BAV. The efficacy of BAV was continuing (P
