Catheterization and Cardiovascular Diagnosis 26:24%254 (1992)
Oriainal Studies Repeat Balloon Aortic Valvuloplasty R. Koning, A. Cribier, C. Asselin, D. Mouton-Schleifer, G. Derumeaux, and B. Letac This paper attempts t o determine limitations and indications of performing a second balloon aortic valvuloplasty procedure (BAV2) because of restenosis, which is the major limitation of this technique. From September 1985 to December 1989, 357 patients underwent a primary BAV (BAV1) and 67 patients had a BAV2. Forty-two patients (group A) had repeat catheterization because they were markedly symptomatic 11 5 7 months after BAV1. Twenty-five patients (group B) came from a group of 73 patients who had been systematically scheduled for repeat catheterization in order t o evaluate the hemodynamic restenosis rate 8 ? 3 months after BAV. At time of BAVZ most of the patients of group A were severely disabled. Comparison of preBAV2 gradient and aortic valve area with pre-BAV1 measurements showed in a slightly less severe degree of aortic stenosis in group A and in group B with any difference in cardiac index and ejection fraction. l m m e diately following BAV2, the gradient decreased from 72 ? 22 to 33 5 15 mm Hg ( P . 0.001) and aortic valve area increased from 0.56 ? 0.18 to 0.85 2 0.28 cmz (p . 0,001) in group A. In group 8 , gradient decreased from 68 ? 15 to 33 2 15 mm Hg (p . 0.001) and aortic valve area increased from 0.70 5 0.16 to 0.90 t 0.25 cm' (p . . 0.001). Comparison of the post-BAV2 peak systolic gradient, aortic valve area, ejection fraction, and cardiac index with post-BAV1 measurements revealed n o significant differences in the two groups, but the absolute increase in aortic valve area obtained at BAV2 was significantly less than at B A V l in group B (0.20 2 0.22 vs 0.31 2 0.16 cm'; p .' 0.02). The larger balloon size used for BAVZ than for BAVl did not increase the final valve area at BAV2. In-hospital mortality was 3%. The use of a better profiled catheter with an arterial introducer explained the lower rate of vascular complications (4%). This report demonstrates that when BAV is indicated a second procedure can be performed safely and with low risk in symptomatic patients. 8 igg2 wiky-uu, inc.
Key words: aortic stenosis, balloon valvuloplasty
INTRODUCTION
Since the introduction of balloon aortic valvuloplasty as a palliative treatment in adult aortic stenosis [ 11, it has been clearly demonstrated that this procedure is able to produce marked immediate clinical and hemodynamic improvement [2,3]. After 4 years of experience with this procedure, its major limitation is undoubtedly a high restenosis rate which has been demonstrated by clinical, echo-Doppler, and hemodynamic follow-up studies [471. Thus, aortic valvuloplasty should be reserved for those patients who cannot undergo surgery, those with a high surgical risk, or as a bridge to surgery in those patients who are in poor clinical condition [8,9]. Because of its low risk, this procedure can be repeated if restenosis occurs in a patient who again cannot be considered for surgical valve replacement. From September 1985 to December 1989, 357 primq aortic valvuloplasty procedures (BAv') 67 pawere performed in our institution. tients underwent a second procedure (BAV2) because of 0 1992 Wiley-Liss, Inc.
restenosis. Through the results reported here, we shall attempt to determine the limitations and indications of performing a second procedure. STUDY POPULATION
A second valvuloplasty procedure (BAV2) was performed on 67 patients, 34 men and 33 women, with a mean age of 73 k 10 years. Eighteen patients were more than 80 years old. In 6 patients, a rheumatic etiology was found and in 2, aortic stenosis was probably congenital.
From the Service de Cardiologie, HBpital Charles Nicolle, Centre Hospitalo-Universitaire, Rouen, France.
Received June 18, 1991; revision accepted January 15, 1992. Address reprint requests to Professeur B . Letac. HBpital Charles Nicolle. Centre HosDitalo-Universitaire. 1 rue de Germont. 76000 Rouen. France.
250
Koning et al.
In the other 59 patients, aortic stenosis was considered secondary to an acquired calcified degenerative process. At the time of BAV 1, 18 patients were good surgical candidates. Of these, 3 patients absolutely refused surgery and 15 patients preferred balloon valvuloplasty (BAV) in order to defer surgery. Of the 49 remaining patients, 11 had absolute contraindications for surgery and 38 were high surgical risk patients with advanced age (> 80 years), severe heart failure, severe inoperable coronary disease, and/or associated pathological conditions such as respiratory insufficiency. BAV2 was performed because of recurrence or aggravation of symptoms or because of asymptomatic hemodynamic restenosis defined as a loss of 50% or more of the increase in valve area obtained by the dilatation [2]. Forty-two patients had repeat catheterization because they were markedly symptomatic (group A ) . BAV2 was performed within a mean time of 1 1 2 7 months. Twenty-eight patients (67%) had marked dyspnea (New York Heart Association Functional class I11 or IV), 11 patients (26%) had angina, and 7 (17%) had syncope with exercise. Restenosis was documented in 32 patients (76%) (mean AVA: 0.54 2 0.15 cm2). For the 10 patients without restenosis, BAV2 was performed because of persistent symptoms coupled with an insufficient hemodynamic result from the initial procedure (mean AVA: 0.71 2 0.15 cm2), thought to be due to the less effective technique employed at that time. Twenty-five patients came from a group of 73 patients who had systematically scheduled repeat catheterization performed to evaluate the hemodynamic restenosis rate (group B). BAV2 was performed at a mean time interval of 8 2 3 months. Restenosis was documented in 16 patients who had a mean aortic valve area of 0.65 2 0.13 cm2. Marked dyspnea was present in 4, angina in 3, and syncope in 2. In 9 other systematically recatheterized patients, although there was no restenosis, insufficient hemodynamic results of BAVI (mean AVA: 0.73 2 0.18 cm2) associated with recurrence of symptoms warranted BAV2. METHODOLOGY
Balloon aortic valvuloplasty was performed as a continuation of the catheterization procedure. Forty-nine of the 67 patients underwent BAV2 during the same protocol employed during their initial dilatation, as previously described [2]. Catheters with balloons of increasing diameter (Boston Scientific, Mansfield) were introduced percutaneously over the guide wire. The diameter of the balloons varied from 15 to 23 mm. The remaining 18 patients benefited from new developments in technique. A 14F sheath was placed in the femoral artery for introduction of a low profile balloon catheter with a pigtail
tip. The balloon was either single sized or double stepped (15 or 18 mm in its distal part and 20 or 23 mm in its proximal part). This new device permitted ventriculoaortic gradient measurements as well as left ventricular and aortic angiograms . In 38 BAV2 procedures, 21 in Group A and 17 in Group B, the mean balloon size was larger than that used in BAVl cases (23 ? 2 mm vs 19 2 2 mm). In 4 cases, early in our experience, the double balloon technique was used (15 + 12mm, 15 + 15 mm, 15 + 18 mm, 15 20 mm). The valve area was calculated using the Gorlin formula. Left ventricular end-diastolic and end-systolic volumes were measured and the ejection fraction was calculated. The mean and standard deviation were calculated for all variables. The paired t test was used to compare quantitative variables and qualitative variables were compared by mean of x2 test.
+
RESULTS Results of BAVl Results of BAVl in Group A and B are shown in Table I. Two patients of group A (5%) and 3 patients of group B (12%) had an increase in aortic valve area less than 25%. Complications involving the femoral puncture site occurred in 6 patients (9%), 3 in group A and 3 in group B. Tamponade not requiring surgical repair occurred in one case of group B. Clinical and hemodynamic parameters before and after BAVl of the study population (groups A and B) and another 290 patients treated during the same period are compared in Table I. Patients of group A were older, with a more critical aortic stenosis due to a lower cardiac index as compared with those of group B. Hemodynamlc and Angiographic Evaluation preBAV2
Comparison of pre-BAV2 gradient and aortic valve area measurements with those of pre-BAV1 showed a slightly less severe aortic stenosis at pre-BAV2 in the two groups (Table 11). There were no differences in the ventricular function parameters (ejection fraction, cardiac index) compared with pre- and post-BAVl measurement. Aortic stenosis was more severe in group A as compared with group B (p < 0.01). Supravalvular artograms were performed in 34 patients, 20 in group A and 14 in group B. Aortic regurgitation was assessed as grade 1 in 5 patients (3 in group A, 2 in group B). Remaining patients had no evidence of aortic insufficiency. Results in BAV2 In group A. Immediately following balloon aortic valvuloplasty , peak to peak systolic gradient decreased
Repeat Balloon Aortic Valvuloplasty
251
TABLE I. Comparison of Clinical and Hemodynamic Parameters at BAV1 Between Group A and Group B and 290 Other Patients Treated by Balloon Aortic Valvuloplasty During the Same Period
Others Mean age (years) Sex Male Female Dyspnea (class 111 or IV NYHA) Angina pectoris Syncope Gradient (mm Hg) Pre-BAV 1 Post-BAVI Aortic valve area (cm’) Pre-BAVI Post-BAVI Cardiac index (liters/min/m2) Pre-BAV I Post-BAV 1 Ejection fraction ( S ) Pre-BAVI Post-BAVI
(n = 290)
Group A (n = 42)
73
76 f 8”.‘
70 27
0.55 0.98
2
11”
Group B ( n = 25) 69
f 11‘
142 148
23 19
11
I97 151 96
31 23 17
17
f f
25“ 13h
78 33
14
14 13
* 23’ f
80 f 25 32 2 12
12b
0.19 0.33
0.50 ? 0.18d 0.90 t 0.35
0.61 2 0.18d 0.92 2 0.27
2.78 2 0.78‘ 2.84 f 0.74
2.77 f 0.77d 2.81 2 0.66
3.19 2.98
53 50
2 f
19 16 ( n = 97) f ?
5 4 f 18 49 f 17 ( n = 16)
* 0.82C.d C
0.71
60 C 16 57 f 15 ( n = 9)
”p
Oriainal Studies Repeat Balloon Aortic Valvuloplasty R. Koning, A. Cribier, C. Asselin, D. Mouton-Schleifer, G. Derumeaux, and B. Letac This paper attempts t o determine limitations and indications of performing a second balloon aortic valvuloplasty procedure (BAV2) because of restenosis, which is the major limitation of this technique. From September 1985 to December 1989, 357 patients underwent a primary BAV (BAV1) and 67 patients had a BAV2. Forty-two patients (group A) had repeat catheterization because they were markedly symptomatic 11 5 7 months after BAV1. Twenty-five patients (group B) came from a group of 73 patients who had been systematically scheduled for repeat catheterization in order t o evaluate the hemodynamic restenosis rate 8 ? 3 months after BAV. At time of BAVZ most of the patients of group A were severely disabled. Comparison of preBAV2 gradient and aortic valve area with pre-BAV1 measurements showed in a slightly less severe degree of aortic stenosis in group A and in group B with any difference in cardiac index and ejection fraction. l m m e diately following BAV2, the gradient decreased from 72 ? 22 to 33 5 15 mm Hg ( P . 0.001) and aortic valve area increased from 0.56 ? 0.18 to 0.85 2 0.28 cmz (p . 0,001) in group A. In group 8 , gradient decreased from 68 ? 15 to 33 2 15 mm Hg (p . 0.001) and aortic valve area increased from 0.70 5 0.16 to 0.90 t 0.25 cm' (p . . 0.001). Comparison of the post-BAV2 peak systolic gradient, aortic valve area, ejection fraction, and cardiac index with post-BAV1 measurements revealed n o significant differences in the two groups, but the absolute increase in aortic valve area obtained at BAV2 was significantly less than at B A V l in group B (0.20 2 0.22 vs 0.31 2 0.16 cm'; p .' 0.02). The larger balloon size used for BAVZ than for BAVl did not increase the final valve area at BAV2. In-hospital mortality was 3%. The use of a better profiled catheter with an arterial introducer explained the lower rate of vascular complications (4%). This report demonstrates that when BAV is indicated a second procedure can be performed safely and with low risk in symptomatic patients. 8 igg2 wiky-uu, inc.
Key words: aortic stenosis, balloon valvuloplasty
INTRODUCTION
Since the introduction of balloon aortic valvuloplasty as a palliative treatment in adult aortic stenosis [ 11, it has been clearly demonstrated that this procedure is able to produce marked immediate clinical and hemodynamic improvement [2,3]. After 4 years of experience with this procedure, its major limitation is undoubtedly a high restenosis rate which has been demonstrated by clinical, echo-Doppler, and hemodynamic follow-up studies [471. Thus, aortic valvuloplasty should be reserved for those patients who cannot undergo surgery, those with a high surgical risk, or as a bridge to surgery in those patients who are in poor clinical condition [8,9]. Because of its low risk, this procedure can be repeated if restenosis occurs in a patient who again cannot be considered for surgical valve replacement. From September 1985 to December 1989, 357 primq aortic valvuloplasty procedures (BAv') 67 pawere performed in our institution. tients underwent a second procedure (BAV2) because of 0 1992 Wiley-Liss, Inc.
restenosis. Through the results reported here, we shall attempt to determine the limitations and indications of performing a second procedure. STUDY POPULATION
A second valvuloplasty procedure (BAV2) was performed on 67 patients, 34 men and 33 women, with a mean age of 73 k 10 years. Eighteen patients were more than 80 years old. In 6 patients, a rheumatic etiology was found and in 2, aortic stenosis was probably congenital.
From the Service de Cardiologie, HBpital Charles Nicolle, Centre Hospitalo-Universitaire, Rouen, France.
Received June 18, 1991; revision accepted January 15, 1992. Address reprint requests to Professeur B . Letac. HBpital Charles Nicolle. Centre HosDitalo-Universitaire. 1 rue de Germont. 76000 Rouen. France.
250
Koning et al.
In the other 59 patients, aortic stenosis was considered secondary to an acquired calcified degenerative process. At the time of BAV 1, 18 patients were good surgical candidates. Of these, 3 patients absolutely refused surgery and 15 patients preferred balloon valvuloplasty (BAV) in order to defer surgery. Of the 49 remaining patients, 11 had absolute contraindications for surgery and 38 were high surgical risk patients with advanced age (> 80 years), severe heart failure, severe inoperable coronary disease, and/or associated pathological conditions such as respiratory insufficiency. BAV2 was performed because of recurrence or aggravation of symptoms or because of asymptomatic hemodynamic restenosis defined as a loss of 50% or more of the increase in valve area obtained by the dilatation [2]. Forty-two patients had repeat catheterization because they were markedly symptomatic (group A ) . BAV2 was performed within a mean time of 1 1 2 7 months. Twenty-eight patients (67%) had marked dyspnea (New York Heart Association Functional class I11 or IV), 11 patients (26%) had angina, and 7 (17%) had syncope with exercise. Restenosis was documented in 32 patients (76%) (mean AVA: 0.54 2 0.15 cm2). For the 10 patients without restenosis, BAV2 was performed because of persistent symptoms coupled with an insufficient hemodynamic result from the initial procedure (mean AVA: 0.71 2 0.15 cm2), thought to be due to the less effective technique employed at that time. Twenty-five patients came from a group of 73 patients who had systematically scheduled repeat catheterization performed to evaluate the hemodynamic restenosis rate (group B). BAV2 was performed at a mean time interval of 8 2 3 months. Restenosis was documented in 16 patients who had a mean aortic valve area of 0.65 2 0.13 cm2. Marked dyspnea was present in 4, angina in 3, and syncope in 2. In 9 other systematically recatheterized patients, although there was no restenosis, insufficient hemodynamic results of BAVI (mean AVA: 0.73 2 0.18 cm2) associated with recurrence of symptoms warranted BAV2. METHODOLOGY
Balloon aortic valvuloplasty was performed as a continuation of the catheterization procedure. Forty-nine of the 67 patients underwent BAV2 during the same protocol employed during their initial dilatation, as previously described [2]. Catheters with balloons of increasing diameter (Boston Scientific, Mansfield) were introduced percutaneously over the guide wire. The diameter of the balloons varied from 15 to 23 mm. The remaining 18 patients benefited from new developments in technique. A 14F sheath was placed in the femoral artery for introduction of a low profile balloon catheter with a pigtail
tip. The balloon was either single sized or double stepped (15 or 18 mm in its distal part and 20 or 23 mm in its proximal part). This new device permitted ventriculoaortic gradient measurements as well as left ventricular and aortic angiograms . In 38 BAV2 procedures, 21 in Group A and 17 in Group B, the mean balloon size was larger than that used in BAVl cases (23 ? 2 mm vs 19 2 2 mm). In 4 cases, early in our experience, the double balloon technique was used (15 + 12mm, 15 + 15 mm, 15 + 18 mm, 15 20 mm). The valve area was calculated using the Gorlin formula. Left ventricular end-diastolic and end-systolic volumes were measured and the ejection fraction was calculated. The mean and standard deviation were calculated for all variables. The paired t test was used to compare quantitative variables and qualitative variables were compared by mean of x2 test.
+
RESULTS Results of BAVl Results of BAVl in Group A and B are shown in Table I. Two patients of group A (5%) and 3 patients of group B (12%) had an increase in aortic valve area less than 25%. Complications involving the femoral puncture site occurred in 6 patients (9%), 3 in group A and 3 in group B. Tamponade not requiring surgical repair occurred in one case of group B. Clinical and hemodynamic parameters before and after BAVl of the study population (groups A and B) and another 290 patients treated during the same period are compared in Table I. Patients of group A were older, with a more critical aortic stenosis due to a lower cardiac index as compared with those of group B. Hemodynamlc and Angiographic Evaluation preBAV2
Comparison of pre-BAV2 gradient and aortic valve area measurements with those of pre-BAV1 showed a slightly less severe aortic stenosis at pre-BAV2 in the two groups (Table 11). There were no differences in the ventricular function parameters (ejection fraction, cardiac index) compared with pre- and post-BAVl measurement. Aortic stenosis was more severe in group A as compared with group B (p < 0.01). Supravalvular artograms were performed in 34 patients, 20 in group A and 14 in group B. Aortic regurgitation was assessed as grade 1 in 5 patients (3 in group A, 2 in group B). Remaining patients had no evidence of aortic insufficiency. Results in BAV2 In group A. Immediately following balloon aortic valvuloplasty , peak to peak systolic gradient decreased
Repeat Balloon Aortic Valvuloplasty
251
TABLE I. Comparison of Clinical and Hemodynamic Parameters at BAV1 Between Group A and Group B and 290 Other Patients Treated by Balloon Aortic Valvuloplasty During the Same Period
Others Mean age (years) Sex Male Female Dyspnea (class 111 or IV NYHA) Angina pectoris Syncope Gradient (mm Hg) Pre-BAV 1 Post-BAVI Aortic valve area (cm’) Pre-BAVI Post-BAVI Cardiac index (liters/min/m2) Pre-BAV I Post-BAV 1 Ejection fraction ( S ) Pre-BAVI Post-BAVI
(n = 290)
Group A (n = 42)
73
76 f 8”.‘
70 27
0.55 0.98
2
11”
Group B ( n = 25) 69
f 11‘
142 148
23 19
11
I97 151 96
31 23 17
17
f f
25“ 13h
78 33
14
14 13
* 23’ f
80 f 25 32 2 12
12b
0.19 0.33
0.50 ? 0.18d 0.90 t 0.35
0.61 2 0.18d 0.92 2 0.27
2.78 2 0.78‘ 2.84 f 0.74
2.77 f 0.77d 2.81 2 0.66
3.19 2.98
53 50
2 f
19 16 ( n = 97) f ?
5 4 f 18 49 f 17 ( n = 16)
* 0.82C.d C
0.71
60 C 16 57 f 15 ( n = 9)
”p
