Balloon valvuloplasty for critical aortic stenosis in the newborn: influence of new catheter technology

Between 1986 and July 1990, balloon valvuloplasty was attempted in eight newborns (less than 28 days of age) with isolated critical aortic valve stenosis. Balloon valvuloplasty could not be successfully accomplished in any of the three infants presenting before 1989. Since March 1989, when improved catheter technology became available, all five neonates presenting with critical aortic stenosis were treated successfully by balloon valvuloplasty. A transumbilical approach was utilized in all four infants in whom umbilical artery access could be obtained. One newborn who was 25 days of age underwent transfemoral balloon valvuloplasty. Balloon valvuloplasty was immediately successful in all five newborns, as evidenced by a decrease in valve gradient and improvement in left ventricular function and cardiac output. Peak systolic gradient was reduced by 64% from 69 +/- 8 to 25 +/- 3 mm Hg (p = 0.005). Left ventricular systolic pressure decreased from 128 +/- 9 to 95 +/- 9 mm Hg (p = 0.02) and left ventricular end-diastolic pressure decreased from 20 +/- 2 to 11 +/- 1 mm Hg (p = 0.02). Moderate (2+) aortic regurgitation was documented in two infants after valvuloplasty. The time from first catheter insertion to valve dilation averaged 57 +/- 14 min (range 26 to 94) and the median length of the hospital stay was 4 days. With the use of recently available catheters, the transumbilical technique of balloon valvuloplasty can be performed quickly, safely and effectively in the newborn with critical aortic stenosis. It does not require general anesthesia, cardiopulmonary bypass or a left ventricular apical incision and it preserves the femoral arteries for future transcatheter intervention should significant aortic stenosis recur.     

Critical pulmonary valve stenosis in patients less than 1 year of age: treatment with percutaneous gradational balloon pulmonary valvuloplasty

A new technique of percutaneous gradational balloon pulmonary valvuloplasty was used successfully in 17 infants less than 1 year of age, including four neonates, with critical congenital pulmonary valve stenosis, who would otherwise have required surgical intervention. This technique uses a sequential series of balloon catheters of gradually increasing size as a means of eventually crossing the very small valve orifice with a balloon catheter of adequate size to achieve successful pulmonary valvuloplasty. The initial dilatations were achieved with balloon catheters 2, 3, or 4 mm in diameter. Immediately after successful balloon valvuloplasty, the mean pulmonary systolic pressure gradient was reduced from 105 +/- 11 to 20 +/- 5 mm Hg. Percutaneous balloon pulmonary valvuloplasty can be performed safely with good results despite critical congenital pulmonary valve obstruction in severely ill infants.     

Use of a 3 French system for balloon aortic valvuloplasty in infants.

For infants with valvar aortic stenosis, balloon aortic valvuloplasty has supplanted surgical valvotomy as the initial treatment of choice at most institutions. Technological innovations have resulted in further miniaturization of balloon dilation catheters, allowing this procedure to be performed through smaller sheath sizes. Currently, the Tyshak-Mini balloon dilation catheter (B. Braun Medical) allows passage of up to an 8 mm dilation balloon catheter through a 3 Fr hemostatic sheath. The efficacy of this system for the treatment of valvar aortic stenosis in infants less than 6 months of age was evaluated in 20 patients undergoing 22 procedures. Mean age at the time of intervention was 26 +/- 46 days. Mean transvalvar gradient was 76 +/- 22 mm Hg prior to balloon dilation. Following balloon valvuloplasty, residual gradient was 26 +/- 12 mm Hg, reflecting a mean change in peak-to-peak gradient of 49 +/- 19 mm Hg. Postintervention increase in aortic insufficiency was one grade or less in 19/22 procedures, two grades in 2 procedures, and three grades in 1 procedure. There were no significant vascular complications reported immediately following the procedure. Repeat valvuloplasty was performed in three patients in which the 3 Fr system was used in two patients. The 3 Fr system for balloon aortic valvuloplasty in infants less than 6 months of age is effective and safe.     

Percutaneous pulmonary valvuloplasty in adults

Percutaneous balloon pulmonary valvuloplasty was performed in 6 adult patients (aged 21-59 years, mean age: 43 years) with congenital pulmonary valve stenosis and systolic pressure gradients of 50 to 120 mm Hg (mean: 78 mm Hg). In 5 patients the procedure was successful: mean systolic right ventricular pressure was reduced from 99 +/- 26 to 55 +/- 7 mm Hg and the trans-stenotic pressure gradient from 77 +/- 28 to 31 +/- 12 mm Hg. Valvuloplasty with a 20 mm balloon was not effective in a patient with a wide pulmonary anulus (diameter 25 mm). In 1 patient only, the balloon occlusion led to severe systemic hypotension with syncope. Short-term follow-up (3 months) demonstrated symptomatic improvement and persistent reduction of the pressure gradient in all successfully treated patients. In conclusion, percutaneous balloon pulmonary valvuloplasty appears to be an effective method with low risk of complications for the treatment of pulmonary valve stenosis in adults.     

Percutaneous balloon aortic valvuloplasty: results in 23 patients

Percutaneous balloon aortic valvuloplasty (BAV) was performed in 23 consecutive patients with valvular aortic stenosis with no associated cardiac defects. The patients were 2 to 17 years old and were referred from 12 hospitals in 4 states. The balloon was positioned across the aortic valve and inflated to pressures of 80, 100, then 120 psi. Each inflation lasted 5 to 10 seconds. The arterial and venous catheters were connected together outside the groin to avoid excessive increase in left ventricular pressure during total aortic valve occlusion with the inflated balloon. Peak systolic aortic valve pressure gradient and cardiac output were measured before and 15 minutes after BAV. There was no significant change in cardiac output, but all patients had a lessened gradient. The gradient before BAV was 113 +/- 48 mm Hg, decreasing to 32 +/- 15 mm Hg after BAV (p less than 0.01). The left ventricular peak systolic pressure decreased from 221 +/- 54 to 149 +/- 21 mm Hg (p less than 0.01). No aortic regurgitation was noted in 13 patients and very mild aortic regurgitation was noted in 10 patients after BAV. The balloons were 10 to 20 mm in diameter, chosen at least 1 mm smaller than the diameter of the aortic valve anulus. Pressures of 100 to 120 psi were required to achieve full inflation of the balloons. Six patients had repeat cardiac catheterization studies 3 to 9 months after BAV. In none was there a significant change in peak systolic aortic valve pressure gradient or cardiac output compared with the study immediately after valvuloplasty.     

Gradient reduction, aortic valve regurgitation and prolapse after balloon aortic valvuloplasty in 32 consecutive patients with congenital aortic stenosis

From 1986 to 1988, balloon aortic valvuloplasty was performed in 32 patients with congenital valvular aortic stenosis. The patients ranged in age from 2 days to 28 years (mean +/- SD 8.3 +/- 5.9). One balloon was used in 17 patients and two balloons were used in 15 patients. Immediately after valvuloplasty, peak systolic pressure gradient across the aortic valve decreased significantly from 77 +/- 27 to 23 +/- 16 mm Hg (p less than 0.01), a 70% reduction in gradient. At early follow-up study (4.1 +/- 3.3 months after valvuloplasty), there was a 48 +/- 20.5% reduction in gradient compared with that before valvuloplasty, and at late follow-up evaluation (19.2 +/- 5.6 months), a reduction in gradient of 40 +/- 29% persisted. Echocardiography showed evidence of significantly increased aortic regurgitation in 10 patients (31%) and aortic valve prolapse in 7 patients (22%). There was no correlation between the balloon/anulus ratio and the subsequent development of aortic regurgitation or prolapse. In fact, no patient who showed a significant increase in aortic regurgitation had had a balloon/anulus ratio greater than 100%. It is concluded that balloon aortic valvuloplasty effectively reduces peak systolic pressure gradient across the aortic valve in patients with congenital aortic stenosis. However, subsequent aortic regurgitation and prolapse occur in a significant number of patients, even if appropriate technique and a balloon size no greater than that of the aortic anulus are used.     

Comparison of single and double balloon valvuloplasty in children with aortic stenosis

To compare the effectiveness of the single and double balloon techniques, the short-term results of percutaneous balloon valvuloplasty were assessed in two consecutive groups of children with valvular aortic stenosis. In 16 children (aged 3 months to 17 years) the single balloon technique was utilized; the ratio of balloon diameter to valve anulus diameter was 0.96 +/- 0.03 (mean +/- SEM). In 11 children (aged 3 months to 21 years) the double balloon technique was utilized in which two balloons are positioned across the valve and inflated simultaneously; the ratio of the balloon diameter sum to valve anulus diameter was 1.32 +/- 0.05. The groups were similar in age, weight, cardiac output, prevalvuloplasty gradient and valve anulus diameter. Overall, valvuloplasty reduced the peak systolic gradient by 53% from 80 +/- 4 to 38 +/- 3 mm Hg (p less than 0.0001). In the single balloon group the gradient decreased from 82 +/- 6 to 46 +/- 4 mm Hg (p less than 0.0001), whereas in the double balloon group the gradient decreased from 76 +/- 5 to 26 +/- 4 mm Hg (p less than 0.0001). The peak systolic gradient after valvuloplasty was 43% lower in the double balloon group (p less than 0.01). Furthermore, the single balloon technique reduced the gradient by an average of 43% compared with a 67% reduction with the double balloon technique (p less than 0.001). The short-term complications of valvuloplasty were similar, with an increase in aortic insufficiency occurring in three children in each group.(ABSTRACT TRUNCATED AT 250 WORDS)     

Results of balloon valvuloplasty in typical and dysplastic pulmonary valve stenosis: Doppler echocardiographic follow-up

To assess the usefulness of balloon valvuloplasty in patients with a dysplastic pulmonary valve, the files of 36 patients (aged 1 day to 18.5 years) who had two-dimensional echocardiography before and continuous wave Doppler echocardiography late after balloon valvuloplasty (balloon diameter greater than or equal to 20% anulus diameter) were reviewed. Results of relief of pulmonary stenosis were graded by catheter gradient in the catheterization laboratory and compared with Doppler echocardiographic findings at follow-up. There were 32 patients with typical pulmonary stenosis and 4 with a dysplastic valve. In the 32 patients with typical pulmonary stenosis, transvalvular gradient changed from a mean of 67 +/- 32 to 20 +/- 20 mm Hg (p less than 0.0001, mean reduction 72.6%). The gradients at follow-up by Doppler echocardiography averaged 20 mm Hg including 15 that increased, 3 that were unchanged and 14 that decreased. Only 3 (9%) of 32 patients had a gradient greater than 25 mm Hg at follow-up and only one gradient was greater than 35 mm Hg. All four patients with a dysplastic valve had a gradient that decreased with valvuloplasty from a mean of 85 +/- 33 to 33 +/- 20 mm Hg (p less than 0.05); gradient reduction in this group ranged from 40 to 85% (mean 57.5%). The gradient at follow-up increased in three of these four patients and decreased in one (the only late gradient less than 25 mm Hg). Late gradient was less than 35 mm Hg in two of the four patients and was reduced by 43 and 57%, respectively, in the other two.(ABSTRACT TRUNCATED AT 250 WORDS)     

Balloon valvuloplasty of congenital pulmonary valve stenosis

Percutaneous balloon valvuloplasty can be considered a therapeutic alternative to surgery for pulmonary valve stenosis. In this analysis, our results will be reported with respect to the various balloon sizes as related to the diameter of the valvular ring as well as differing balloon catheters and the presence of other anomalies in addition to pulmonary valve stenosis. Balloon valvuloplasty was carried out in 23 infants and children ranging in age from one month to eleven years and in two adults at the age of 22 and 50 years, respectively, with a systolic pressure gradient across the pulmonary valve of more than 50 mm Hg or, in the presence of pressure gradients between 40 and 50 mm Hg, in association with a right ventricular pressure of at least 60% of that of the systemic pressure. In all patients echocardiography was carried out prior to the procedure to rule out valve dysplasia and Doppler echocardiographic determination of the pressure gradient was performed before and after dilatation. The diameter of the valvular ring was measured echocardiographically as well as from the right ventriculogram and the size of the balloon chosen accordingly. After diagnostic catheterization, the balloon catheter was advanced to the pulmonary valve with a guidewire. Under fluoroscopy, the balloon was completely inflated then the contrast medium immediately withdrawn, a procedure of seven to 23 seconds with the single-balloon catheter and five to nine seconds with the trefoil catheter. At the first dilatation, the larger portion of the balloon was advanced to the main stem of the pulmonary artery and was placed proximally for subsequent dilatations.(ABSTRACT TRUNCATED AT 250 WORDS)     

Balloon aortic valvuloplasty: results of the Valvuloplasty and Angioplasty of Congenital Anomalies Registry

Data from 204 children and infants who underwent aortic balloon valvuloplasty between 1982 and 1986, reported to the Valvuloplasty and Angioplasty of Congenital Anomalies Registry, were reviewed. Valvuloplasty was successful in 192 of 204 children, reducing the peak systolic left ventricular ejection gradient from 77 +/- 2 to 30 +/- 1 mm Hg, p less than 0.001. The same degree of aortic stenosis gradients reduction was noted in both the 38 children under 1 year of age and in the 166 children over 1 year of age. Significant complications included death, aortic regurgitation and femoral artery thrombosis or damage. The incidence of these complications correlated with the age of the child, the ratio of valvuloplasty balloon size/anulus size, or both. The data suggest that percutaneous balloon valvuloplasty provides effective acute relief of valvar aortic stenosis in both infants and children. However, long-term follow-up data are necessary before balloon valvuloplasty can be established as a treatment of choice for congenital valvar aortic stenosis.     

Intermediate-term effectiveness of balloon valvuloplasty for congenital aortic stenosis. A prospective follow-up study.

BACKGROUND. Percutaneous balloon valvuloplasty has proven to be acutely effective in the treatment of congenital valvar aortic stenosis; however, the intermediate- and long-term effectiveness of the procedure remain to be documented. METHODS AND RESULTS. To assess the intermediate-term effectiveness of balloon valvuloplasty, repeat catheterization was performed in 27 of 30 children 1.7 +/- 0.1 years after balloon valvuloplasty for congenital aortic stenosis (AS). In 33 children the peak AS gradient was reduced acutely by 55% from 77 +/- 4 to 35 +/- 3 mm Hg (p less than 0.001), and left ventricular systolic pressure was reduced from 176 +/- 4 to 138 +/- 4 mm Hg (p less than 0.001). Despite a technically adequate valvuloplasty procedure, three patients had inadequate relief of obstruction and required complex surgical intervention. Twenty-seven of the 30 patients available for late reevaluation (90%) enrolled in the follow-up study. The peak AS gradient remained significantly reduced compared with that present before valvuloplasty (29 +/- 3 versus 77 +/- 4 mm Hg, p less than 0.001). Furthermore, there was no difference in peak AS gradient at follow-up compared with that immediately after valvuloplasty. The greatest increase in gradient at reevaluation was 14 mm Hg. Twenty of 27 patients (74%) had no change in the degree of aortic insufficiency at follow-up compared with that present before valvuloplasty. At follow-up, 16 patients had no aortic insufficiency at all, and only two had moderate-to-severe (3-4+) insufficiency. Femoral artery injury was documented in four patients, three of whom were under 12 months of age at valvuloplasty. CONCLUSIONS. Balloon aortic valvuloplasty provides safe and effective intermediate-term gradient relief without early restenosis in children and adolescents with congenital AS.     

Dual balloon technique for valvuloplasty of aortic stenosis in adults

A dual balloon technique was studied in 16 patients with aortic stenosis in whom results with a single balloon (up to 20 mm, 5.5 cm or 25 mm, 3.0 cm in diameter and length, respectively) were judged to be suboptimal. Dual balloon valvuloplasty was performed using 2 balloons advanced and inflated simultaneously across the stenotic aortic valve orifice. For the group as a whole, the average peak transvalvular gradient was reduced from 79 +/- 8 to 57 +/- 7 mm Hg (mean +/- standard error) using a single balloon (p less than 0.0005), and reduced further to 36 +/- 4 mm Hg using dual balloons (p less than 0.0005 compared with single balloon results). Similarly, calculated aortic valve orifice area was increased from 0.45 +/- 0.04 to 0.57 +/- 0.05 cm2 using a single balloon (p less than 0.0005), and further increased to 0.77 +/- 0.06 cm2 using dual balloons (p less than 0.0005). Dual balloon dilation caused no complications directly attributable to the use of 2 balloons, including no exacerbation of aortic regurgitation. These results suggest that dual balloon valvuloplasty is safe and efficacious in selected patients with aortic stenosis.     

Treatment of calcific aortic stenosis by balloon valvuloplasty

Recent reports have established the feasibility of using balloon valvuloplasty to reduce left ventricular outflow tract obstruction due to a calcified aortic valve. The present study summarizes experiences with this technique in 9 patients (7 women, 2 men, mean age 78 years) in whom balloon valvuloplasty was used to treat calcific aortic stenosis. Peak aortic valve gradient (mm Hg) decreased from 68 +/- 8 (mean +/- standard error of the mean) before valvuloplasty to 35 +/- 5 after valvuloplasty (p = 0.003). Mean aortic valve gradient decreased from 57 +/- 7 before valvuloplasty to 30 +/- 5 after valvuloplasty (p = 0.006). Calculated aortic valve area increased from 0.42 +/- 0.04 to 0.81 +/- 0.06 cm2 (p = 0.005). Balloon valvuloplasty failed to diminish aortic valve obstruction in only 1 patient who, at subsequent surgery, had a congenitally bicuspid aortic valve. Significant aortic regurgitation was not observed in any of the 9 patients after valvuloplasty. One patient did have a highly focal, presumably embolic, brain stem infarct during the procedure. Femoral arterial blood loss, related to wire-guided exchange of balloon catheters too large for a 12Fr introducer sheath, was minimized by direct arterial exposure in 8 of the 9 patients. Thus, these findings confirm the efficacy of balloon valvuloplasty for the treatment of calcific aortic stenosis. The procedure, however, is not without hazard.     

Percutaneous balloon valvuloplasty for aortic stenosis: improved quality of life for elderly patients

From September 1986 to September 1987 percutaneous balloon valvuloplasty was performed in 20 patients with critical aortic stenosis. The mean age was 74, range 54 to 90 years. Two patients were NYHA class II, 10 patients were functional class III and eight were class IV. After percutaneous balloon valvuloplasty, using 15, 18 or 20 mm diameter balloon catheters via a 14F vascular sheath from the femoral artery, one patient was class I, 11 class II and seven were class III. One patient, who had only minimal reduction of aortic valve gradient from 120 to 100 mmHg, remained in class IV. The systolic gradient was reduced by 50% from 70 +/- 26 (+/- SD) to 35 +/- 22 mmHg (P less than 0.001) after valvuloplasty and the aortic valve area increased by 43% from 0.51 +/- 0.12 to 0.73 +/- 0.25 cm2 (P less than 0.001). There were no procedural or 30 day deaths nor any embolic events. Percutaneous balloon valvuloplasty is a relatively safe and effective treatment for the older adult with symptomatic aortic stenosis.     

经皮球囊扩张术治疗儿童先天性主动脉瓣狭窄

目的探讨儿童先天性主动脉瓣狭窄（aortic stenosis,AS）球囊扩张的治疗效果。方法选择21例单纯性AS患儿,其中1例合并动脉导管未闭（PDA）,3例因导管难以进入左室,2例左心导管测跨主动脉瓣压力阶差（AP）小于50mmHg（1mmHg=0．133kPa）而未扩张,其余16例采用与瓣环直径之比为0．98±0．04（0．92～1．10）的球囊扩张治疗,合并的PDA予Amplatzer伞片封堵治疗。结果即刻AP下降至原AP50％以上者13例,占81．25％;下降至原AP40％～50％者2例。随访6个月～5年,3例患儿AP回复至50mmHg以上,分别予第二次扩张或外科手术后好转。无一例轻度以上的主动脉瓣反流。结论AS经皮球囊扩张术结果表明,球囊扩张对单纯性AS具有一定疗效,由于其非开胸、方便且较安全地缓解左心室流出道梗阻,从而可替代或延缓外科开胸瓣膜切开术,为AS的治疗提供了另外一种选择。     

Double balloon technique for dilation of valvular or vessel stenosis in congenital and acquired heart disease

Despite the generally excellent success with balloon dilation for the stenotic lesions of congenital and acquired heart disease, technical difficulties sometimes prevent satisfactory results. Such technical difficulties include: a large diameter of the anulus of the stenotic lesion relative to available balloon diameter, difficulty in the insertion or removal of the larger balloon catheters, and permanent damage to or obstruction of the femoral vessels by the redundant deflated balloon material of the large balloons. A double balloon technique was initiated to resolve these difficulties. With this method, percutaneous balloon angioplasty catheters were inserted in right and left femoral vessels, placed side by side across the stenotic lesion and inflated simultaneously. Dilation procedures using the two balloon technique were performed in 41 patients: 18 with pulmonary valve stenosis, 14 with aortic valve stenosis, 5 with mitral valve stenosis, 3 with vena caval obstruction following the Mustard or Senning procedure and 1 with tricuspid valve stenosis. Patient ages ranged from 1 to 75 years (mean 17.8) and patient weights ranged from 8.9 to 89 kg (mean 42.3). Balloon catheter sizes ranged from 10 to 20 mm in diameter. Average maximal pressure gradient in mm Hg before dilation was 61 in pulmonary stenosis, 68 in aortic stenosis, 21 in mitral stenosis, 12 in tricuspid stenosis and 25 in vena caval stenosis. Average maximal valvular pressure gradient after dilation was 13 in pulmonary stenosis, 24 in aortic stenosis, 4 in mitral stenosis, 0 in tricuspid stenosis, and 1 in vena caval stenosis. No major complications were encountered with the procedures.(ABSTRACT TRUNCATED AT 250 WORDS)     

Combined percutaneous aortic valvuloplasty and transluminal coronary angioplasty in adult patients with calcific aortic stenosis and coronary artery disease

Of 120 consecutive balloon aortic valvuloplasty procedures for critical aortic stenosis, valvuloplasty was performed in combination with coronary angioplasty in nine patients (average age 76 years). All nine patients were symptomatic with angina and congestive heart failure before combined procedures. Aortic valvuloplasty was performed with 20 to 23 mm balloon catheter advanced retrogradely from the femoral artery and resulted in an improvement in peak aortic valve gradient (60 +/- 19 to 33 +/- 13 mm Hg; p less than or equal to .01) and calculated aortic valve area (0.7 +/- 0.1 to 1.1 +/- 0.3 cm2; p less than or equal to .01). Single-vessel coronary angioplasty was performed via the femoral approach, with 2.0 to 3.5 mm balloon catheters, and resulted in a mean reduction of a critical coronary stenosis in each patient from 91 +/- 4% to 29 +/- 8%. The site of coronary angioplasty was the left anterior descending artery in three patients, the circumflex artery in three patients, the right coronary artery in two patients, and a bypass graft to the right coronary artery in one patient. Combined procedures were performed with a mean arterial time of 108 min. Complications included groin hematomas (n = 2), transient left bundle branch block (n = 1), and transient atrial fibrillation (n = 1). No patient experienced prolonged chest pain, myocardial infarction, major increase in aortic insufficiency, or embolic phenomena. Eight of the nine patients treated with combined procedures noted significant improvement in symptoms of angina and congestive heart failure and were discharged.(ABSTRACT TRUNCATED AT 250 WORDS)     

Carotid artery approach for balloon dilation of aortic valve stenosis in the neonate: a preliminary report

Balloon valvuloplasty in neonates with severe aortic valve stenosis is limited by difficulties in catheter manipulation around the arch and across the valve and by the risk of femoral artery complications. A right common carotid artery cutdown was utilized for balloon aortic valvuloplasty in five neonates 1 to 20 days of age, weighing 3.1 to 3.9 kg. Standard balloon valvuloplasty was performed through a 6F sheath inserted in the right carotid artery. The arteriotomy was repaired at the end of the procedure. Mean left ventricular systolic pressure was reduced from 142 to 97 mm Hg, with a decrease in mean peak systolic pressure gradient from 76 to 33 mm Hg. Only one patient developed mild aortic regurgitation. One patient with a hypoplastic left ventricle died, and one patient required open valvotomy. All four survivors have a normal carotid pulse and no neurologic sequelae. Two of these patients required repeat balloon dilation to treat residual aortic valve stenosis at 8 and 10 months of age, respectively. Balloon valvuloplasty using a carotid artery approach is feasible and was safe in five neonates with severe aortic valve stenosis.     

Double vs single balloon technique for aortic balloon valvuloplasty

Percutaneous aortic valvuloplasty using a single dilating balloon has been associated with significant but modest reduction in transvalvular pressure gradient and increase in valve area. The balloon diameter is usually 20 mm or smaller to avoid disruption of aortic root structure and to permit forward blood flow during inflation. To evaluate the safety and efficacy of valvuloplasty using a combination of balloons with larger maximum inflated diameters, we compared results of aortic valvuloplasty in 21 patients using either the single or double balloon technique. Mean maximum inflated balloon diameter was 19.4 mm +/- 1.4 for the single balloon technique, while the mean sum of diameters for the simultaneous double balloon technique was 36.3 mm +/- 3.9. The mean age, aortic annulus diameter, and predilatation aortic valve area were not different among groups. Mean aortic transvalvular gradient reduction and mean aortic valve area increase were greater for the double balloon technique. The procedure was well tolerated with no major complications. No change in the degree of aortic regurgitation was noted. The double balloon technique for aortic valvuloplasty is safe and more effective at improving aortic valve area and transvalvular gradient than the conventional single balloon technique.     

Aortic percutaneous transluminal valvuloplasty in elderly patients by balloon larger than aortic anulus

Twenty-four elderly patients (79 +/- 7 years) with long-standing calcified aortic stenosis have been divided in two comparable groups of 12. The first group was treated with 19 mm balloon percutaneous transluminal valvuloplasty, where the balloon diameter was always smaller than the aortic anulus diameter. Peak-to-peak aortic valve gradient decreased from 76 +/- 32 mmHg to 30 +/- 19 (P less than .05), and the aortic valve area, calculated by Gorlin formula, increased from 0.40 +/- 0.17 cm2 to 0.57 +/- 0.17 (P less than .05). The second group was treated with a trefoil 25 mm balloon, always larger than the aortic anulus diameter. In this second group, peak-to-peak aortic valve gradient decreased from 73 +/- 34 mmHg to 23 +/- 15 (P less than .05), and aortic valve area increased from 0.47 +/- 0.14 cm2 to 0.88 +/- 0.36 (P less than .05), increasing thus more than in group I (P less than .05). Clinical tolerance to balloon inflation was not the same according to individual patients but was similar between the two groups; complications were comparable in the two groups. These results suggest that aortic valvuloplasty by trefoil balloon larger than aortic anulus can provide wider aortic valve area without increasing complication rate.