Results of repeat percutaneous balloon valvuloplasty for pulmonary valvar restenosis

Follow-up cardiac catheterization studies were used to evaluate 105 patients who had undergone percutaneous balloon pulmonary valvuloplasty. Fifteen of those patients who had peak systolic pulmonary valve gradients greater than = 40 mm Hg at follow-up underwent repeat balloon valvuloplasty. For the initial balloon pulmonary valvuloplasty, the mean ratio of the balloon diameter to pulmonary valve annulus diameter was 0.98 +/- 0.2; at repeat valvuloplasty the mean was 1.19 +/- 0.12. The immediate post-repeat balloon valvuloplasty results showed a reduction in the peak systolic gradient from a mean of 70.2 +/- 17.8 to 29.1 +/- 19.0 mm Hg (p less than 0.001). This reduction in the gradient was maintained at a mean of 14.3 +/- 5.0 mm Hg in 8 of the 10 patients who underwent further follow-up studies. We conclude that successful repeat balloon pulmonary valvuloplasty with the use of larger sized balloons is feasible in patients who have restenosis after the initial percutaneous balloon valvuloplasty--including partial but not complete dysplasia of the pulmonary valve.     

Balloon catheter dilation of severe pulmonary restenosis 11 years after surgical valvulotomy

A young girl who underwent repair of an atrial septal defect and pulmonary valvulotomy when 6 years of age, presented with clinical and haemodynamic signs of pulmonary restenosis 11 years later: right ventricular systolic pressure (RVSP) of 130 mmHg with a systolic RV/PA pressure gradient of 105 mmHg. Pulmonary valvuloplasty was performed using a balloon catheter (20 mm X 40 mm). Two inflations were necessary to correct the hour glass deformity of the balloon caused by the stenosis. After valvuloplasty the RVSP was 75 mmHg and the RV/PA gradient 55 mmHg. The calculated pulmonary valve surface area increased from 0.36 cm2 to 0.72 cm2. Angiography performed immediately after dilatation showed improved valvular mobility but here was persistant severe infundibular hypertrophy. The intensity of the pulmonary systolic murmur decreased. The good result obtained in this case shows that percutaneous valvuloplasty may be considered when restenosis occurs several years after surgical valvulotomy. Control catheterisation performed two months after dilatation confirmed the good initial haemodynamic result.     

Further observations on the effect of balloon size on the short term and intermediate term results of balloon dilatation of the pulmonary valve

The relation between the size of the balloon used for dilatation of the pulmonary valve and the extent of relief of pulmonary stenosis both immediately after and at intermediate term follow up was studied. Sixty four balloon dilatation procedures in 56 patients were divided into group 1-12 in which the ratio of the diameter of the balloon to that of the pulmonary annulus was less than or equal to 1.0--and group 2-52 in which the ratio was greater than 1.0. Both groups had similar mean (SD) pressure drops across the pulmonary valve before dilatation. Immediately after dilatation there was a significant reduction in the pulmonary valve gradient in both group 1 (84.3 (39.2) v 43.6 (26.8) mm Hg) and group 2 (92.8 (42.1) v 22.4 (13.6)mm Hg). On intermediate term follow up (6-34 months), residual pulmonary valve gradients were significantly lower in group 2 (20.8 (18.5)mm Hg) than in group 1 (75.0 (49.4) mm Hg), suggesting that restenosis was more common after dilatation with small balloons. These data suggest that although the immediate results with either small or large balloons are good, balloons that are larger than the pulmonary valve annulus produce more sustained relief of pulmonary stenosis. Further analysis within the group treated with larger balloons showed that the subgroup with a balloon/annulus ratio of 1.01-1.2 had more recurrences of stenosis (need for repeat balloon dilatation and larger number of patients with residual pulmonary valve gradients greater than 30 mm Hg) than subgroups with balloon/annulus ratios for diameters of 1.21-1.41, greater than 1.41, and greater than 1.5, in which there were no recurrences. Balloons that were > 1.5 times the size of the pulmonary valve annulus had no additional advantage over the other subgroups, namely, 1.21-- 1.4 and > 1.41. These results and reports of damage to the right ventricular outflow tract by oversized (> 1.5) balloons indicate that balloons that give a balloon/annulus ratio 1.2 -- 1.5 are the best for dilatation of the pulmonary valve.     

Further observations on the effect of balloon size on the short term and intermediate term results of balloon dilatation of the pulmonary valve.

The relation between the size of the balloon used for dilatation of the pulmonary valve and the extent of relief of pulmonary stenosis both immediately after and at intermediate term follow up was studied. Sixty four balloon dilatation procedures in 56 patients were divided into group 1-12 in which the ratio of the diameter of the balloon to that of the pulmonary annulus was less than or equal to 1.0--and group 2-52 in which the ratio was greater than 1.0. Both groups had similar mean (SD) pressure drops across the pulmonary valve before dilatation. Immediately after dilatation there was a significant reduction in the pulmonary valve gradient in both group 1 (84.3 (39.2) v 43.6 (26.8) mm Hg) and group 2 (92.8 (42.1) v 22.4 (13.6)mm Hg). On intermediate term follow up (6-34 months), residual pulmonary valve gradients were significantly lower in group 2 (20.8 (18.5)mm Hg) than in group 1 (75.0 (49.4) mm Hg), suggesting that restenosis was more common after dilatation with small balloons. These data suggest that although the immediate results with either small or large balloons are good, balloons that are larger than the pulmonary valve annulus produce more sustained relief of pulmonary stenosis. Further analysis within the group treated with larger balloons showed that the subgroup with a balloon/annulus ratio of 1.01-1.2 had more recurrences of stenosis (need for repeat balloon dilatation and larger number of patients with residual pulmonary valve gradients greater than 30 mm Hg) than subgroups with balloon/annulus ratios for diameters of 1.21-1.41, greater than 1.41, and greater than 1.5, in which there were no recurrences. Balloons that were > 1.5 times the size of the pulmonary valve annulus had no additional advantage over the other subgroups, namely, 1.21-- 1.4 and > 1.41. These results and reports of damage to the right ventricular outflow tract by oversized (> 1.5) balloons indicate that balloons that give a balloon/annulus ratio 1.2 -- 1.5 are the best for dilatation of the pulmonary valve.     

Significance of infundibular obstruction following balloon valvuloplasty for valvar pulmonic stenosis

This study was designed to define the prevalence and significance of infundibular obstruction following balloon pulmonary valvuloplasty. Thirteen of 62 children had infundibular gradients prior to valvuloplasty; five of these disappeared following balloon valvuloplasty. Five other children without pre-valvuloplasty infundibular gradients but with angiographic infundibular narrowing developed new infundibular gradients following valvuloplasty. Propranolol was administered to six children because of severe infundibular constriction, with improvement. None required surgical intervention. At follow-up the infundibular gradients either diminished or disappeared. The infundibular gradients appear to be more frequent with increasing age and severity of pulmonary valvar obstruction. Children developing systemic or suprasystemic right ventricular pressures after balloon pulmonary valvuloplasty may be candidates for propranolol therapy. Regression of the infundibular stenosis at follow-up can be expected, as has been observed after surgical pulmonary valvotomy. Because the infundibular obstruction can be successfully managed, balloon pulmonary valvuloplasty remains the treatment of choice for isolated valvar pulmonary stenosis. Use of balloon valvuloplasty in children less than 5 years of age and/or prior to development of pulmonary gradients in excess of 80 mm Hg may reduce the chance for development of infundibular reaction.     

Success determining factors in percutaneous transluminal balloon valvuloplasty of pulmonary valve stenosis

Twenty-two percutaneous transluminal balloon valvuloplasty procedures were performed on 21 patients with congenital pulmonary valve stenosis. The peak systolic pressure gradient was immediately reduced from 79.1 +/- 7.4 to 22.2 +/- 1.8 mmHg, (P less than 0.0001) and follow-up cardiac catheterization at 5.3 +/- 0.4 months in 19 patients revealed no further significant change in gradient (23.5 +/- 3.2 mmHg). The best results were obtained when balloons larger than the pulmonary annulus were used, i.e. an immediate residual transvalvular gradient of 22.0 +/- 2.2 mmHg with a balloon/annulus ratio greater than 1, as opposed to 44.2 +/- 5.4 with a balloon/annulus ratio = 1 (P less than 0.001). The angiographically determined cusp thickness of the stenotic pulmonary valves was significantly greater than that of the control group of 24 patients without pulmonary valve stenosis (1.21 +/- 0.09 vs 0.59 +/- 0.02 mmHg, P less than 0.00001). The relationship between this parameter and the residual transvalvular gradient at follow-up was found to be significant (r = 0.77, P less than 0.001). It is concluded that balloon size is a determinant factor in achieving good results with percutaneous balloon valvuloplasty although cusp thickness, a factor to which scant regard has hitherto been paid, also plays a significant role in the residual transvalvular gradient measured at follow-up.     

Percutaneous valvuloplasty of congenital pulmonary stenosis in adults over 50 years of age

The authors report three cases of congenital pulmonary stenosis in adults over 50 years of age treated by percutaneous balloon valvuloplasty. Three symptomatic women aged 74, 80 and 51, had systolic pressure gradients ranging from 107 to 113 mmHg between the right ventricle and pulmonary artery. After valvuloplasty with two balloons or one trefoil balloon, the transvalvular pressure gradient fell to 25 to 30 mmHg. It was only 14 mmHg in one patient controlled after one year's follow-up. The cardiac index was initially decreased and did not change very much immediately after the procedure, increasing from 1.68 1/m2/mn to 1.77 1/m2/mn. The pulmonary valve surface area increased from 0.22 to 0.43 cm2. There were no complications and in one patient, reviewed two years later, the clinical improvement was maintained. Percutaneous valvuloplasty is indicated in severe and/or poorly tolerated pulmonary stenosis. With the 10 other previously reported cases of patients over 50 years of age, the procedure was successful in 12 out of 13 patients (92%). In these patients of 51 to 80 years of age, the systolic pressure gradient between the right ventricle and pulmonary artery was reduced from 112 +/- 46 mmHg to 43 +/- 26 mmHg (-62%). Slight pulmonary regurgitation appeared in 5 out of 9 cases. Valvuloplasty was usually well tolerated and there were no fatalities. There were no signs of restenosis in 5 cases controlled 10 days to 1 year after dilatation. In the future, systematic Doppler echocardiographic examinations should help comparison of cardiac haemodynamics before, immediately after valvuloplasty and at long-term.(ABSTRACT TRUNCATED AT 250 WORDS)     

Balloon dilatation of calcific aortic stenosis in elderly patients: postmortem, intraoperative, and percutaneous valvuloplasty studies

To assess the safety and efficacy of percutaneous balloon valvuloplasty in calcific aortic stenosis, balloon dilatation of critically stenosed, calcified aortic valves was performed in five postmortem hearts, in five patients intraoperatively before aortic valve replacement, and in two elderly patients percutaneously at the time of diagnostic catheterization. The etiology of aortic stenosis in the 12 cases was rheumatic in two, congenital bicuspid calcific stenosis in one, and senile calcific degenerative stenosis in the remaining nine. Prevalvuloplasty examination in the 10 postmortem and intraoperative cases revealed rigid valve leaflets with commissural fusion in three valves and extensive nodular calcification in seven. Subsequent balloon dilatation with 15 to 18 mm valvuloplasty balloons resulted in decreased cusp rigidity and increased mobility of valve leaflets in all cases, without evidence of tearing of valve leaflets, disruption of the valvular ring, or liberation of calcific or valvular debris. In the three valve specimens with commissural fusion, balloon dilatation resulted in partial or complete separation of leaflets along fused commissures. In two cases with extensive nodular calcification, balloon dilatation resulted in a fracture of a calcified leaflet that was evident on both gross and radiologic examination. After postmortem and intraoperative studies, percutaneous catheter valvuloplasty was performed at the time of diagnostic catheterization in two elderly patients (93- and 85-year-old women) with long-standing calcific aortic stenosis. Balloon dilatation with 12 to 18 mm balloons resulted in significant decreases in aortic gradients and significant increases in cardiac index and aortic valve area in both patients. Percutaneous valvuloplasty in both patients resulted in a mild increase in aortic insufficiency and no evidence of embolic phenomena.     

Balloon pulmonary valvuloplasty after initial pulmonary valvotomy for pulmonary atresia with intact ventricular septum]

Seven patients with pulmonary atresia and intact ventricular septum have undergone closed pulmonary valvotomy on the early neonatal period (2-6 days) with satisfactory results. Follow-up catheterization showed significant residual pulmonary valve stenosis requiring a second operation. Percutaneous balloon dilatation of the pulmonary valve was successful in 6 cases with the mean right ventricular systolic pressure reduced from 6.8 to 4.9 kPa (50.8 to 37 mmHg) and the mean transvalvular gradient dropped from 5.7 to 2.1 kPa (4.28 to 15.8 mmHg). One case failed and required surgical treatment. The results showed that balloon valvuloplasty could be applied instead of surgery for treatment of selected cases of pulmonary atresia with intact ventricular septum after an initial pulmonary valvotomy.     

Indications and outcome of valvuloplasty

Balloon valvuloplasty is widely practiced, but its result depends on the pathology considered. Percutaneous mitral balloon valvuloplasty evolved from the earlier development of percutaneous balloon valvotomy of the pulmonic valve into an effective method for the treatment of patients with mitral stenosis. Percutaneous aortic balloon valvotomy has been used as an alternative to aortic valve replacement in elderly patients with degenerative calcific aortic stenosis, but immediate results are suboptimal and the short-term rate of restenosis is high. In congenital pulmonary valve stenosis, balloon valvotomy produces a dramatic relief of the pressure gradient with excellent long-term follow-up results.     

Percutaneous Balloon Valvuloplasty of A Porcine Xenograft Bioprosthesis in the Mitral Position: Late (1 Year) Hemodynamic Observations

Balloon valvuloplasty is a procedure recently applied to porcine xenograft bioprostheses. We report the percutaneous dilatation of a critically stenosed Carpentier-Edwards bioprosthesis in the mitral position via an atrial transseptal approach. Hemodynamic measurements revealed an increase in mitral valve area from 0.88 cm² to 1.34 cm² and a decrease in the transvalve gradient from 22 mmHg to 12 mmHg. The patient's symptoms dramatically improved, but recurred 8 months later. Repeat cardiac catheterization at 1 year documented restenosis of the porcine xenograft bioprosthesis with a mitral valve area of 0.87 cm². Thus, stenosis of porcine bioprostheses may be managed by balloon valvuloplasty. As with native valves subjected to balloon valvuloplasty, restenosis is a concern.     

Neonatal isolated critical aortic valve stenosis: balloon valvuloplasty or surgical valvotomy

BACKGROUND: Open surgical valvotomy and transcatheter balloon valvuloplasty are recognised treatments for neonatal critical aortic stenosis. METHODS: A retrospective analysis was undertaken of all newborns with critical aortic valve stenosis between 1990 and 2000 presenting to a tertiary centre and who required intervention. The initial catheter and surgical intervention was generally based on the preference of the attending cardiologist and the anatomy of the aortic valve and in consultation with the cardiothoracic surgeon. The two groups were therefore not strictly comparable. Twelve were subjected to balloon valvuloplasty and thirteen to surgical valvotomy at a median age of 11 days (2-42 days) and 3.5 days (1-19 days) respectively. There was no significant difference in the timing of the procedure, weight of the infant, aortic annulus or left ventricular dimensions in either group. RESULTS: There was one unrelated hospital death in the balloon group compared to two in the surgical group both of whom had endocardial fibroelastosis. Mild to moderate aortic regurgitation was seen after both procedures. Four patients in the balloon valvuloplasty group, developed femoral artery thrombosis and two had cardiac perforation that resolved with non operative management. The mean Doppler gradient was reduced from 44+/-14 mmHg to 13.4+/-5 mmHg (p<0.01) in the valvuloplasty group compared to a reduction from 42+/-15 mmHg to 27+/-8 mmHg (p<0.05) in the surgical group. Five patients in the balloon group required re-intervention within 3 weeks to 21 months after the initial procedure. Two patients in the surgical group required a pulmonary autograft and Konno Procedure 3 and 5 years following surgical valvotomy. CONCLUSION: Both aortic valvuloplasty and valvotomy offered effective short and medium term palliation. Balloon valvuloplasty patients had a higher re-intervention rate but shorter hospital and intensive care stay, reduced immediate morbidity and were associated with less severe aortic regurgitation.     

The morphology of the right ventricular outflow tract after percutaneous pulmonary valvotomy: long term follow up.

Twenty nine patients (19 male, mean (SD) age 6.25 (0.5) years (range 0.16-15 years] with typical pulmonary valve stenosis were treated by balloon dilatation of the pulmonary valve. They were studied by echocardiography before the procedure, immediately after it, and at follow up (mean (SD) 10.2 (5.6) months, n = 18). The morphology of the pulmonary valve, the right ventricular-pulmonary artery gradient, and ratio of the systolic to diastolic endocardial dimensions (infundibular ratio) were examined. No patient had pulmonary regurgitation before the study. The valve gradient was significantly reduced (47%) from a mean (SD) of 72 (31) to 37 (23) mm Hg with no short term change in cardiac index after dilatation with a balloon with a mean (SD) diameter that was 118 (10.8)% of the valve annulus. The infundibular ratio was unchanged by the procedure (0.49 (0.11) (n = 21) before dilatation and 0.47 (0.14) (n = 16) after dilatation). In twenty seven patients the commissure of the pulmonary valve was seen to be torn after dilatation. Two patients with bicuspid valves had flail leaflets. Doppler examination at follow up showed mild pulmonary insufficiency in all 29 patients; the mean (SD) valve gradient (31 (+/- 21) mm Hg) at follow up was no different from the gradient found immediately after the procedure and infundibular ratio (0.58 (0.15) was not abnormal. These data indicate that commissural tears are the primary mechanism of valve disruption and demonstrate that the dynamic right ventricular outflow tract obstruction relaxes and gradient reduction persists at follow up.     

Balloon valvuloplasty and angioplasty in congenital heart disease

Balloon dilatation valvuloplasty was performed in 16 patients with pulmonary valve stenosis aged 10 days to 17 years. Gradients were reduced in all but two patients and were less than or equal to 20 mm Hg after the procedure in all but these two and one other. Unsatisfactory initial results in these three patients were attributed to the use of too small a balloon in one patient (gradient subsequently abolished at repeat valvuloplasty), to a dysplastic valve in a neonate, and to the fact that there had been a previous surgical valvotomy with scar tissue formation in one patient. The good result was retained in six of seven patients followed up at three to six months. In one the gradient, having been reduced from 60 to 18 mm Hg, had risen to 35 mm Hg. Repeat valvuloplasty was technically impossible in this patient, but in two others residual gradients of 24 and 22 mm Hg were reduced to 4 and 8 mm Hg respectively by repeat valvuloplasty. Balloon dilatation angioplasty was successful in dilating a severe stenosis at the lower limb of an atrial baffle (previous correction of complete transposition) and in dilating supravalvar stenosis of the pulmonary artery resulting from previous banding and debanding. Thus balloon pulmonary valvuloplasty, though still a new technique, appears to be the treatment of choice in patients with typical pulmonary stenosis and thin mobile valves. Patients with dysplastic valves may be less suitable candidates for the procedure. Balloon angioplasty is likely to have other applications, including the treatment of postoperative stenotic lesions.     

The morphology of the right ventricular outflow tract after percutaneous pulmonary valvotomy: long term follow up

Twenty nine patients (19 male, mean (SD) age 6.25 (0.5) years (range 0.16-15 years] with typical pulmonary valve stenosis were treated by balloon dilatation of the pulmonary valve. They were studied by echocardiography before the procedure, immediately after it, and at follow up (mean (SD) 10.2 (5.6) months, n = 18). The morphology of the pulmonary valve, the right ventricular-pulmonary artery gradient, and ratio of the systolic to diastolic endocardial dimensions (infundibular ratio) were examined. No patient had pulmonary regurgitation before the study. The valve gradient was significantly reduced (47%) from a mean (SD) of 72 (31) to 37 (23) mm Hg with no short term change in cardiac index after dilatation with a balloon with a mean (SD) diameter that was 118 (10.8)% of the valve annulus. The infundibular ratio was unchanged by the procedure (0.49 (0.11) (n = 21) before dilatation and 0.47 (0.14) (n = 16) after dilatation). In twenty seven patients the commissure of the pulmonary valve was seen to be torn after dilatation. Two patients with bicuspid valves had flail leaflets. Doppler examination at follow up showed mild pulmonary insufficiency in all 29 patients; the mean (SD) valve gradient (31 (+/- 21) mm Hg) at follow up was no different from the gradient found immediately after the procedure and infundibular ratio (0.58 (0.15) was not abnormal. These data indicate that commissural tears are the primary mechanism of valve disruption and demonstrate that the dynamic right ventricular outflow tract obstruction relaxes and gradient reduction persists at follow up.     

Balloon valvuloplasty and angioplasty in congenital heart disease.

Balloon dilatation valvuloplasty was performed in 16 patients with pulmonary valve stenosis aged 10 days to 17 years. Gradients were reduced in all but two patients and were less than or equal to 20 mm Hg after the procedure in all but these two and one other. Unsatisfactory initial results in these three patients were attributed to the use of too small a balloon in one patient (gradient subsequently abolished at repeat valvuloplasty), to a dysplastic valve in a neonate, and to the fact that there had been a previous surgical valvotomy with scar tissue formation in one patient. The good result was retained in six of seven patients followed up at three to six months. In one the gradient, having been reduced from 60 to 18 mm Hg, had risen to 35 mm Hg. Repeat valvuloplasty was technically impossible in this patient, but in two others residual gradients of 24 and 22 mm Hg were reduced to 4 and 8 mm Hg respectively by repeat valvuloplasty. Balloon dilatation angioplasty was successful in dilating a severe stenosis at the lower limb of an atrial baffle (previous correction of complete transposition) and in dilating supravalvar stenosis of the pulmonary artery resulting from previous banding and debanding. Thus balloon pulmonary valvuloplasty, though still a new technique, appears to be the treatment of choice in patients with typical pulmonary stenosis and thin mobile valves. Patients with dysplastic valves may be less suitable candidates for the procedure. Balloon angioplasty is likely to have other applications, including the treatment of postoperative stenotic lesions.     

Factors influencing late course of residual valvular and infundibular gradients following pulmonary valve balloon dilatation.

BACKGROUND: Though acute and follow-up benefits of pulmonary valve balloon dilatation (PVBD) for pulmonic valve stenosis are well known, the late course of residual gradients at individual valvular and infundibular levels is not well described. Furthermore, the factors influencing this late course have not been studied. MATERIALS AND METHODS: We assessed the transpulmonary gradients by echo-Doppler in 96 patients (61 male, mean age 10.7 years) at a mean follow-up interval of 58.8+/-32.1 months (minimum 2 years) following PVBD. The patients were divided into three groups based on the residual gradients at valvular and infundibular levels immediately following PVBD as assessed by pull-back of an end-hole catheter across the right ventricular outflow tract: Group A with minor pressure gradients at both valvular and infundibular levels of less than 30 mmHg (n=60, 62.5%), Group B with predominantly infundibular gradients of more than 30 mmHg with a valvular gradient of less than 30 mmHg (n=27, 28.1%), and Group C with a residual valvular gradient of greater than 30 mmHg irrespective of the infundibular gradient (n=9, 9.4%). Demographic characteristics, hemodynamic parameters and procedural variables were correlated with the change in gradient at follow-up (late fall) and with long-term results. RESULTS: The mean follow-up trans-pulmonary gradient was 20+/-14 mmHg which was significantly lower than that immediately post-PVBD (43+/-32 mmHg), P<0.001. The late fall (mean 24+/-29, range -55 to 110 mmHg) varied widely depending upon the acute result group: patients in Groups A and B showed significant late fall of 9+/-12 mmHg (P<0.05 for follow-up gradient compared to that following PVBD) and 58+/-31 mmHg (P<0.0001), respectively, while patients in Group C showed an insignificant late fall of 14+/-37 mmHg (P=0.21). In particular, each one of the patients in Group B showed decrease in trans-pulmonary gradients. On multivariate analysis, the extent of infundibular gradient emerged as the most important predictor of late fall (coefficient of determination 75%, P<0.0001). Patients who underwent PVBD at less than 2 years of age had a significantly greater late fall (41+/-33 mmHg) as compared to older patients (22+/-25 mmHg), P<0.05. A sub-optimal long-term result (transpulmonary gradient >25 mmHg, n=24) was significantly related to older age (P<0.001), dysplastic valve morphology (P=0.002), greater baseline trans-pulmonary gradients (P<0.001) and higher post-PVBD gradients (P=0.04). CONCLUSIONS: The long-term course of patients following PVBD depends upon the site and magnitude of the residual gradients. Even high residual infundibular gradients show marked reduction at follow-up, especially in infancy.