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Comparison between single (Inoue) and double balloon mitral valvuloplasty: Immediate and short-term results
Comparison between single (Inoue) and double balloon mitral valvuloplasty: Immediate and short-term results This study compared the results in 60 consecutive patients with severe rheumatic mitral stenosis, who underwent percutaneous double-balloon mitral valvuloplasty by means of a combination of 20 mm + 20 mm diameter balloon catheters (group A), with a similar group of 60 consecutive patients who underwent single (moue) balloon mitral valvuloplasty (group 6). After balloon mitral valvuloplasty the hemodynamic measurements showed significant improvement in both groups: in groups A and 6, respectively, mitral valve area calculated with the Gorlin formula increased from 0.9 t 0.2 to 2.1 t 0.5 cm2 (p < 0.001) and from 0.6 k 0.2 to 1.9 f 0.4 cm2 (p < 0.001). There was a significant improvement in cardiac functional status in both groups. There was no significant difference between the groups with regard to clinical or hemodynamic improvement, technical failure rate, inadequacy of dilatation, or complications. However, the double-balloon technique was more complex and involved a longer screening time-group A, 40 ? 12 minutes; group 8, 21 i- 10 minutes (p < 0.001). In our institution the disposable supplies used for the lnoue balloon technique were 40% more expensive than those used for the double-balloon technique. (AM HEART J 1992;123:1561.)
Moheeb Abdullah, MRCP, Murtada Halim, MRCP, Vijayaraghavan Rajendran, MRCP, William Sawyer, MD, and Muayed al Zaibag, FRCP. Riyadh, Saudi Arabia
The first successful percutaneous balloon mitral valvuloplasty was reported by Inoue et a1.l in 1984; these investigators used a single-balloon catheter designed for mitral valvuloplasty (Inoue balloon). A single balloon designed for peripheral arterial angioplasty had been used in the United States for mitral dilatation.2 Because the results were less than ideal (mitral valve area = 1.0 to 1.5 cm2) and the Inoue balloon was not commercially available, the single-balloon technique was soon replaced by the so-called “doubleballoon technique,” in which two balloon catheters (Mansfield Scientific, Mansfield, Mass.) were used. This institution began to use the double-balloon technique in 198L3 The procedure has subsequently become very well established as an alternative to the surgical treatment of severe rheumatic mitral stenosis.“-s Between January 1990 and May 1991, the Inoue single-balloon technique of mitral valvuloplasty also was used in 60 consecutive patients with severe rheumatic mitral stenosis (group B). The reFrom
the Riyadh
Received Reprint Riyadh
4/l/36248
Cardiac
for publication
Center,
Armed
Aug. 26, 1991;
requests: Dr. Moheeb Armed Forces Hospital,
Forces accepted
Hospital. Dec.
Abdullah, Department PO Box 7897, Riyadh
2, 1991. of Adult Cardiology, 11159, Saudi Arabia.
sults in this group of patients were compared with those in the first 60 consecutive patients with severe rheumatic mitral stenosis who had undergone double-balloon mitral valvuloplasty with a combination of 20 mm + 20 mm diameter balloon catheters (group A). The parameters compared were clinical improvement, mitral valve area achieved, technical failure, inadequacy of dilatation, complication rate, and ease of the procedure. METHODS
Between February 1987and January 1989,a total of 60 consecutive patients with symptomatic severe rheumatic mitral stenosisunderwent double-balloon mitral valvuloplasty with a combination of 20 mm + 20 mm diameter balloon catheters (group A). This combination of balloon catheter sizeswasdemonstratedby Zaibaget al9 to achieve the best result. Patient characteristics are shownin Table I. Atria1 fibrillation waspresent in nine patients (15% ). All of thesepatients, aswell asthe majority of the patients in sinusrhythm, received anticoagulation therapy (warfarin) for 8 weeksbefore the procedure. Nine patients (15%) had undergone previous surgical mitral valvuloplasty. Fortysevenpatients (78%) had no angiographic mitral regurgitation (MR), 12patients (20%) had MR grade l/4, and one patient had MR grade 214.No patient had MR grade 314 or 414 (Grossmanscale0 to 4). 1581
1582 Table
Abdullah et al. I. Patient baselinecharacteristics Group A
Group
Age range (yr)
16-17 33 k 10
14-63 34 + 12
32 28 l.l:l
17 43 0.4:1
B
Diameter (extra)
29 30 1 1.6
(48 % ) (50%) (2%) _t 0.2
23 34 3 1.6
(38%) (54%) (5%) k 0.2
47 (78%) 12 (20%)
38 (63%) 22 (37%) -
13 (22%)
10 (17%)
35 (58%)
44 (73%)
LISA, body surface area; NYHA,
New York Heart
Between January 1990and May 1991, a total of 60 consecutive patients underwent Inoue single-balloon mitral valvuloplasty for symptomatic severe rheumatic mitral stenosis(group B) (Table I). The size of the balloons used wasdetermined accordingto patient body surfacearea and height as shown in Table II. The maximum balloon diameter usedat full inflation ranged from 24 to 31 mm; 26 mm and 28 mm were the sizesmost commonly used.Atria1 fibrillation waspresent in six patients (10%); these patients together with 22 patients (37%) in sinus rhythm received warfarin for 8 weeksbefore the procedure. The six patients with atria1 fibrillation underwent transesophagealechocardiography in the 24 hours preceding the procedure. Ten patients (17%) had undergone previous surgical mitral valvotomy. Thirty-eight patients (63%) had no angiographic MR and 22 (37%) had MR grade 114.No patient in group B had MR that wasmore than grade l/4. There wasno significant difference between the two groups with regard to the degreeof MR before balloon mitral valvuloplasty. Comprehensivetwo-dimensionalechocardiography with spectral and color Doppler imaging was performed in all patients in both groupsbefore balloon mitral valvuloplasty, to ascertain the presenceof severerheumatic mitral stenosis,to determine the degreeof MR and the morphology of the mitral valve, to exclude left atria1thrombus, and to determine the presenceand degreeof other associatedvalve lesions. The exclusion criteria in both groups for balloon valvuloplasty were: left atria1 thrombus, MR more than grade 214,and other associatedvalve lesionsnecessitating surgery in their own right. The baseline characteristics of age, weight, body surface area, functional class, calcifica-
(mm)
Size
L
Male Female Ratio NYHA class II III IV Mean BSA (m2) Degree of angiographic MR No MR Grade l/4 grade 2/4 Fluoroscopic evidence of calcification (leaflet, commissures, or both) Other valve lesions (mild to moderate degree) MI?, Mitral regurgitation; Association.
II. Guidelines for selection of Inoue balloon size
Table
Characteristics
Mean(yr) Sex
June 1992 Heart Journal
American
M S ss
26-30 24-28 22-26 20-24
L, Large; h’, medium;
(31) (29) (27) (25)
Surface area
fm9 > = 1.9 > = 1.6 > = 1.3 <1.3
Height
(cm)
>180 >160 >147 = <147
S, small: SS. very small.
tion of the mitral valve, previous mitral valvuloplasty, and severity of mitral stenosiswere similar in both groups, although there were more malesin group A (p < 0.01). Procedure. Each patient signed an informed consent form for the procedure. All of the operatorsperforming the proceduresin group A were experienced and competent in the particular double-balloon mitral valvuloplasty technique used, which has been described previously.3 The Inoue technique hasalsobeen describedin detail15;a stepwise mitral valve dilatation technique was used. Pulmonary angiography with levophase was performed before transseptalpuncture to delineate the left atrium. Heparin, 150 units/kg, wasgiven immediately after the transseptal puncture. In both groups A and B, hemodynamic data were obtained from all patients before the balloon mitral valvuloplasty and at the conclusionof the procedure. These included transmitral valve diastolic gradient calculated by means of direct left atrium/left ventricle (LA/LV) pressures(except for one patient in group B with a St. Jude aortic valve prosthesis)and cardiac output determined by meansof the thermodilution method. The mitral valve area wascalculated by meansof the Gorlin formula. An oxygen saturation run wasobtained after balloon mitral dilatation to assessthe presenceof left-to-right shunt through any iatrogenic atria1septaldefect. Left ventricular angiography was performed in all patients before and after the procedure to assess the presenceand degreeof MR. Patients in group B had echo-Doppler studies after each inflation to assessmitral valve area, commissural split, and degreeof MR. Similar studies were performed in group A if the operator thought they were required. The echocardiography machinesused were Toshiba Sonolayer models SSH65A and SSHlGOA (Toshiba Corporation, Tokyo, Japan). Two-dimensional echocardiography with spectral and color Doppler imaging wasperformed in all patients within 24 hours of the procedure and at 24-hour and 6-week follow-up studies. The mitral valve area wasdetermined by
Doppler imaging according to the pressure half-time method describedby Hatle et al.1° The degreeof commissural split following the procedure was determined. The images were recorded pendent analysis.
on magnetic
tape for future
inde-
The symptomatic status of the patients-New York Heart Association (NYHA) functional class-was compared in both groups at 6-week follow-up studies.
Volume Number
123 6
Inoue versus double-balloon
LA
Fig. 1. Comparison of mean mitral sure) before and after percutaneous
valvuloplasty
1583
p~0.001
lM.Q#1
El
mitral
Dtwmm?
Post valvuloplasty
valve diastolic gradient (Gradient) and left atrial pressure (LA presbetween group A and group B. balloon mitral valvuloplasty
t&VA oma 2.5 P*Q.QQ?
P~O.001
1
T1.*0.3
21
Group A
P~Q.001
Tr.*ow
Group 3
1.893.4
Group A
RPPLER n
PI‘S vatvutq‘3fmy
Group 3
CIi”THETER I
Post
valv~loplasty
Fig. 2. Comparison of mitral valve area (MVA) measured by Doppler pressure half-time (Doppler) and Gorlin formula (Catheter) before and after percutaneousballoon mitral valvuloplasty betweengroup A and group B. Statistical analysis. Continuous variables are expressed as mean + standard deviation. Paired and unpaired t tests, together with chi-square or Fisher’s exact tests where appropriate, were used to analyze differences within and between the groups. RESULTS Hemodynamics.
The measured hemodynamic parameters showed significant improvement in both groups immediately after balloon valvuloplasty (Figs. 1, 2, and 3 and Table III). There was no significant
statistical difference in the final result achieved between group A and group B with regard to mitral valve area, mitral valve diastolic gradient, pulmonary artery systolic pressure, left atria1 pressure, and cardiac index. Technical failure. Technical failure-defined as the inability to advance the balloon across the mitral valve for various reasons-occurred in three patients (5 5%)in group A and two (3%) in group B. In group A one patient had cardiac tamponade after transseptal puncture before the insertion of the balloon. This
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Fig. 3. Comparisonof cardiac index before and after percutaneousballoon mitral valvuloplasty between group A and group B.
Table
III. Comparison of hemodynamic results before and after balloon mitral valvuloplasty in groups A and B Group
Hemodynamics Mean left atria1 pressure (mm Hg) Mean mitral valve diastolic gradient (mm Hg) Mean mitral valve area (cm2) Cardiac index (L/min/cm2) Pulmonary artery mean systolic pressure (mm Hg)
Before dilatation
A
Group
B
After dilatation
Before dilatation
After dilatation
22 f 4 14 f 4.5
12 jr 5* 4.5 + 2.3*
20 + 6 12.4 + 4.8
11 -t 3* 3.5 t 1.7*
0.9 + 0.5 2.3 + 0.5 46 k 16
2.1 i 0.5* 2.8 i. 0.5* 39 k 6*
0.8 +- 0.2 2.2 * 0.5 43 f 20
1.9 I 0.4* 2.4 + 0.5* 40 i- 17t
*p < 0.001. tp < 0.01.
patient underwent emergency surgery during which a hemorrhagic pericardial effusion was seen. Open mitral valvuloplasty was performed with no complications. In the other two patients, crossing the mitral valve with two balloons proved impossible. Both underwent open mitral valvuloplasty a few weeks later. In group B one patient had tamponade after transseptal puncture. Pericardiocentesis was performed in the cardiac catheter laboratory; after stabilization he underwent mitral valve replacement. In the other patient in group B, it was difficult to cross the atria1 septum with the balloon, and she underwent open mitral valvuloplasty a few weeks later. Inadequate dilatation. Inadequate dilatation-defined as a final mitral valve area of less than 1.5 cm2-occurred in two patients (3 % ) in each group. Of the two patients in group A, one had undergone pre-
vious mitral valvuloplasty in 1976; he had moderate calcification of the mitral valve. During the balloon mitral valvuloplasty there was imperfect alignment of both balloons across the mitral valve. The mitral valve area increased from 0.5 to 1.2 cm2 with mild MR. The patient improved symptomatically after balloon mitral valvuloplasty and was subsequently managed with medical therapy. The other patient had moderate calcification of the mitral valve, and the maximum mitral valve area achieved was 1.2 cm2. Because he continued to be symptomatic, open mitral valvuloplasty was performed. Of the two patients in group B, one with severe mitral stenosis (mitral valve area = 0.5 cm2) underwent stepwise dilatation with balloon diameters of 22, 24, and 26 mm, respectively; he had mild MR after the first dilatation and subsequently had moder-
Volume Number
123 6
Inoue versusdouble-balloonmitral valvuloplusty 1585 NYHA I
-
II
-
0
Pre-PTBMV
0
Post-PTBMV
III IV -
GROUP
A
GROUP
B
Fig. 4. Comparisonof New York Heart Association (NYHA) functional classbefore and after percutane-
ous transvenousballoon mitral valvuloplasty (PTBMV) between group A and group B (patients who underwent cardiac surgery were excluded).
ate MR (grade 2 to 3/4) with a final mitral valve area of 1.1 cm2. The degree of MR that developed caused the procedure to be abandoned at that stage; the patient underwent mitral valve replacement a few weeks later. The second patient had undergone previous mitral valvuloplasty and aortic valve replacement with a St. Jude valve in 1986. Despite use of the maximum balloon inflation size (31 mm diameter), the maximum valve area achieved was 1.1 cm2 with no MR. The patient then underwent the double-balloon technique with a combination of 20 mm + 20 mm balloon catheters; however, despite good alignment of both balloons across the valve, the valve area remained the same. He was then referred for cardiac surgery, and during the surgical procedure the mitral valve was found to be severely thickened, deformed, and fibrosed, and it was replaced with a St. Jude mechanical valve. Two-dimensional echocardiographic and Doppler studies. These studies were performed in both groups
on the day after balloon mitral valvuloplasty. The mitral valve area measured by Doppler imaging guided by color flow mapping increased from 0.9 f 0.2 to 1.9 -+ 0.3 cm2 (p < 0.001) in group A and from 0.9 ? 2 to 1.9 f 0.3 cm2 (p < 0.001) in group B. Both commissures were judged to be split adequately in 50 of 58 patients (86 % ) in group A and 54 of 59 patients (91% ) in group B. All of the patients who underwent mitral balloon valvuloplasty were reassessed6 weeks after the procedure, and two-dimensional echocardiographic and Doppler studies were performed at that time. The mitral valve area (1.9 + 0.2 cm2) and degree of MR remained the same in both groups. Complications. There were no procedure-related
IV. Comparisonof mitral regurgitation after percutaneousballoon mitral valvuloplasty betweengroupsA and B Table
Degree of MR No change One grade down One grade up Two grades up Three grades up Four grades up
MR.
Mitral
Group
A
34 (60%) 1(2%) 12 (21%)
5(9%)
Group
B
36(62%) 3 (5%) 14(24%) 3(5%)
p Value
>0.5 >0.5 >0.5 >0.5
2 (3%)
2 (3%)
>0.5
3(5%)
0
>0.5
regurgitation.
deaths in either group. No thromboembolic complications, loss of consciousness, or significant bleeding occurred in either group. Tumponade. One patient in each group had cardiac tamponade related to transseptal puncture. Both patients were stabilized and underwent open mitral valvulop!asty. Mitral regurgitation. Only five patients (8%) in group A and two patients (3 % ) in group B had moderately severe to severe MR (grade 3 to 4/4) (Table IV). Only one patient in group A required emergency mitral valve replacement for severe MR, inasmuch as he was hemodynamically unstable. The remaining four patients in group A and the two patients in group B were treated medically because they were not very symptomatic. Predilatation severity of mitral stenosis, degree of MR, calcification of the mitral valve, and patient age and sex were not found to be predictors of any postdilatation increase in MR. Atria1 septal defect. No patient in either group had
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significant left-to-right (L:R) shunt-defined as L:R >1.4:1-after the procedure. Other complications. One patient in group A had a femoral arteriovenous fistula. Screening time. The mean screening time for diagnostic cardiac catheterization and balloon mitral valvuloplasty was 40 k 12 minutes in group A and 21 f 10 minutes in group B (p < 0.001). Cost. The charges for the disposable supplies used for balloon valvuloplasty in our hospital in groups A and B were 1870 and 2600 United States dollars, respectively. Clinical improvement. At the 6-week follow-up studies there was significant clinical improvement in both groups. All patients in group A were in NYHA functional class I or II compared to 45% before the procedure (p < 0.001). All patients in group B were in NYHA functional class I or II compared to 38% before the procedure (p < 0.001) (Fig. 4). DISCUSSION
Percutaneous transvenous balloon mitral valvuloplasty for symptomatic severe rheumatic mitral stenosis has achieved good results in many centers, proving the effectiveness and safety of the procedure.]+? The two techniques used principally are the Inoue procedure, which uses a specially designed single balloon, and the double-balloon technique. This study compared the results in 60 consecutive patients who underwent double-balloon mitral valvuloplasty with a combination of 20 mm + 20 mm balloons with findings in the first 60 consecutive patients who underwent the Inoue single-balloon technique. Although this study was not randomized, both groups had symptomatic severe mitral stenosis with similar baseline characteristics apart from sex distribution. Previously published comparisons between these two methods of balloon mitral valvuloplasty usually have been in disparate groups of patients.i’ The populations in these two groups had many of the same characteristics: both were relatively young and had pliable valves, although 13 o/oto 14 % of the valves were calcific. Thus a study comparing the results of balloon mitral valvuloplasties with a different technique in each of these two groups is valid. The patients in North American reports of mitral balloon dilatation are usually older and have more deformities of the mitral valve.12v l3 However, the known mechanism of balloon valvulotomy of the mitral valve, the closely matched success of the two techniques in our series, and the acceptable results reported by Feldman and Carrolli with the Inoue technique in older patients with deformed valves all
American
June 1992 Heart Journal
would indicate that the overall results would probably be about the same for the two techniques in homogeneous North American populations. In this study equally good results were achieved when patients with severe rheumatic mitral stenosis underwent balloon mitral valvuloplasty by means of either the single- or double-balloon technique. After balloon mitral valvuloplasty there was significant improvement in the NYHA functional class in both groups, with an adequate and significant increase in mitral valve area and decreases in the transmitral valve pressure gradient, mean left atria1 pressure, and pulmonary artery systolic pressure, together with an increase in the cardiac index. There was no significant statistical difference between the two groups with regard to clinical or hemodynamic improvement. The mitral valve areas achieved in both groups were similar to results from other reported series that used either of the two techniques: Previously published results of double-balloon mitral valvuloplasty reported the achievement of mitral valve areas between 1.5 and 2.4 cm2 14; Inoue and Hung,15 on the other hand, reported achieving a mean mitral valve area of 1.97 ~fr0.04 cm3 in 527 patients with the use of a single-balloon technique. The incidence of technical failure was similar in both groups: 5% in group A and 3% in group B. The incidence of technical failure was 2.3 % in the Inoue series15 and 3% in the Vahanian series.23 In a similar study by Chen et a1.,16 comparing single- and double-balloon techniques, the success rate was higher (96 ‘% ) and the complication rate lower in the single-balloon group compared to the doubleballoon group. However, in that study the incidence of technical failure with the double-balloon technique was much higher (33%) than the usually accepted rate; this could possibly be due to the early learning phase of that group for the double-balloon technique. The incidence of inadequate valve dilatation was 3 ‘$Oin both groups A and B. The low incidence of inadequate dilatation in group A, compared to other studies in which the double-balloon technique was used (9% to 11%),20,23 is related to our use of large balloon size (20 mm + 20 mm). In both groups the balloon mitral valvuloplasty procedure produced very few complications, and there were no procedure-related deaths. Cardiac tamponade was the most serious problem encountered-with an incidence of 1.7% in both groupsand it only occurred as a result of transseptal puncture. Tamponade as a complication of transseptal puncture occurs in 1% -3% in large series.15* 17,‘1
Volume Number
123 6
Perforation of the left ventricle has been reported in less than 2% in the double-balloon mitral valvuloplasty technique. I7 The length of the Mansfield balloons and their sharp-tipped configuration contribute in some instances to ventricular perforation.18, lg This problem was not encountered in either group in this study. In group A this could be the result of the use of pigtail balloons, whereas in group B the special design features of the Inoue balloon results in a “fail-safe” movement away from the apex of the left ventricle toward the mitral valve, locking onto the mitral valve during balloon inflation, making the risk of left ventricular perforation very low.14, l6 After balloon mitral valvuloplasty the incidence of an increase in MR of one grade or more was similar in the two groups (36% in group A; 31% in group B), and this was similar to findings in other reported series (30% to 60%). 17,x 22 However, the incidence of moderately severe to severe MR was lower in group B, although it did not reach statistical significance: 8 70 and 3 % for groups A and B, respectively. An increase in MR of more than two grades occurs in 4% to 13 “0 in large series.17y 21,22 The lower incidence in group B may be attributable to the stepwise dilatation, which was made possible by the design of the Inoue balloon, and also to the use of echo-Doppler imaging after each dilatation to assess the commissural split, the mitral valve area achieved, and the degree of MR. The detection of any increase in MR would indicate that further dilatation would carry the risk of a further increase. Such stepwise dilatation and echo-Doppler assessment between each dilatation is not easily feasible with the double-balloon technique. In the double-balloon technique a major cause of MR, other than tear of the anterior or posterior leaflet, is chordae rupture, caused mainly by the malalignment or entanglement of the balloon catheters between the chordae. Chordae rupture is less likely to occur with the use of the Inoue single balloon, because the balloon is advanced across the mitral valve slightly inflated, functioning as a flow-directed catheter, thus decreasing the chance of entanglement in the chordae. Creation of an iatrogenic atria1 septal defect is an integral part of both procedures to pass the balloon from the right to the left atrium. In both groups there was no significant L:R shunt through an atria1 septal defect. The low incidence of atria1 septal defect in group A compared with that in other double-balloon series is a result of the use of two separate I4F transseptal sheaths through which the balloons are advanced into and pulled back from the left atrium. Also the low incidence of atria1 septal defect in
Inoue versus double-balloon
mitral
valvuloplasty
1587
patients in group B in our series compares favorably with the experience of others; Chen et a1.,i6 who used 14F dilators and the Inoue technique, similar to us, did not find a significant incidence of atria1 septal defect. The double-balloon technique involves two separate transseptal punctures with a 14F long sheath as described here or a single transseptal puncture with balloon dilatation of the atria1 septum and passage of two sets of balloon and wire devices across the atria1 septum, through the left atrium, across the mitral valve, and into the left ventricle. Positioning of the wires into the left ventricle leads frequently to ventricular dysrhythmia, resulting in hemodynamic disturbances. The Inoue technique, on the other hand, involves single transseptal puncture and single balloon dilatation of the mitral valve. Its special design allows the balloon to be stretched and “slenderized,” maintaining a low profile (4.5 mm), for passage across the atria1 septum. The Inoue balloon may be floated, similar to a flotation catheter, or directly steered into the left ventricle. The shorter inflation and deflation times (less than 3 seconds) and the lower inflation pressure (1 to 2 atm), compared to the slow inflation and deflation times and 3 atm pressure of conventional balloons, minimize the duration of hemodynamic disturbances.14r I5 The double-balloon technique is definitely more complex and cumbersome, and the mean screening time required is double that for the Inoue single-balloon technique. Inasmuch as one of the advantages of percutaneous balloon mitral valvuloplasty is the ability to repeat the process without the trauma of surgery, cumulative screening times must be regarded as an important potential risk. Few reports have been published on the use of bifoil or trefoil ballooned catheters to dilate the stenotic mitral valve.24* 25 The procedure is reported by Pate1 et a1.26to have a mean fluoroscopy time of 34 minutes, which approximates that for double-balloon mitral valvuloplasty. The procedure involves the use of a 10 mm diameter balloon catheter to dilate the transseptal puncture. Overall the single-catheter bifoil or trefoil balloon technique may have some advantages over the double-balloon technique, but its advantages if any over the Inoue single-balloon technique are minimal. In this series the cost to our institution of the disposable supplies used in the Inoue technique was 40 % more than the cost for the double-balloon technique, but we believe that these costs are justified in light of the ease with which the Inoue balloon catheter is used because of its special design features. Although the total cost of closed mitral valvotomy
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may be lower than that of balloon mitral valvuloplasty in third world countries, the reverse is true in North America.27 The surgeons at this institution do not perform closed mitral valvotomy; however, the overall cost comparison would be closer to the North American ratio than the third world model. In conclusion, both the Inoue-single balloon and the double-balloon mitral valvuloplasty procedures are safe and effective nonsurgical modalities of treatment for severe rheumatic mitral stenosis in selected patients. Both techniques produce equally good results with a low incidence of complications. There was no significant difference between the two groups with regard to clinical or hemodynamic improvement, mitral valve area achieved, and rate of complications. The less complicated and easier Inoue singleballoon technique, although 40 % more expensive, justifies the extra cost involved. We thank Janice Clarke-Piccioni typing the manuscript.
and Marlene
Bernardino
for
REFERENCES
T, Kitamura F, Miyamoto N. 1. Inoue K, Owak T, Nakamura Clinical application of transvenous mitral commissurotomy by a new balloon catheter. J Thorac Cardiovasc Surg 1984;87:394402. 2. Lock JE, Khalilullah M, Shrivastava S, Bahl V, Keane JF. Percutaneous catheter commissurotomy in rheumatic mitral stenosis. N Engl J Med 1985;313:1515-8. 3. Zaibag MA, Kasab SA, Ribeiro PA, Fagih MR. Percutaneous double balloon mitral valvotomy for rheumatic mitral stenosis. Lancet 1986;1:757-61. 4. Babic UU, Pejcic P, Djurisic Z, Vucinic M, Grujicic SM. Percutaneous transarterial balloon valvotomy for mitral stenosis. Am J Cardiol 1986;57:1101-4. RG. Lock JE. Keane JF. Safian RD. Aroestv JM, 5. McKav Grossman W. Percutaneous mitral valvuloplasty in adult patients with calcific rheumatic stenosis. J Am Co11 Cardiol 1986;7:1410-5. 6. Palacios IF, Lock JE, Keane JF, Block P. Percutaneous transvenous balloon valvotomy in a patient with severe calcific mitral stenosis. J Am Co11 Cardiol 1986;7:1416-9. 7. Palacios IF, Block P, Wilkins G, Rediker D, Daggett W. Percutaneous mitral balloon valvotomy during pregnancy in a patient with severe mitral stenosis. Cathet Cardiovasc Diagn 1988;15:109-11. 8. Rediker DE, Block PC, Abasacal VM, Palacious IF. Mitral balloon valvuloplasty for mitral restenosis after surgical commissurotomy. J Am Co11 Cardiol 1988;11:252-6. PA, Al Kasab S, Halim M. Percutaneous 9. Zaibag MA, Ribeiro double-balloon mitral valvotomy: results using different sized balloon catheters. J Am Co11 Cardiol 1987;9:82A. 10. Hatle L. Aneelsen B. Tromsdal A. Non-invasive assessment of atrioventricmar pressure half-Time by Doppler ultrasound. Circulation 1979;60:1096-104.
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Ribeiro PA, Fawzy ME, Arafat MA, Dunn B, Sriram R, Mercer E, Duran CG. Comparison of mitral valve area results of balloon mitral valvotomy using the Inoue and double balloon techniques. Am J Cardiol 1991;68:687-8. Casale PN, Stewart WJ, Whitlow PL. Percutaneous balloon valvotomy for patients with mitral stenosis: initial and follow-up results. AM HEART J 1991;121:476-9. Herrmann HC, Wilkins GT, Abascal VM, Weyman AE, Block PC, Palacios IF. Percutaneous balloon mitral valvotomy for patients with mitral stenosis. J Thorac Cardiovasc Surg 19889633-8. Feldman T, Carroll JD. Valve deformity and balloon mechanics in percutaneous transvenous mitral commissurotomy. AM HEART J 1991;121:1628-33. Inoue K, Hung JS. Percutaneous transvenous mitral commissurotomy (PTMC): the Far East experience. In: Top01 E. Textbook of interventional cardiology, 1st ed. Philadelphia: WB Saunders, 1990:887-99. Chen CR, Huang ZD, Lo ZX, Cheng TO. Comparison of single rubber-nylon balloon and double polyethylene balloon valvuloplastv in 94 patients with rheumatic mitral stenosis. AM HEART-J 199O;i19:102-11. Ruiz CE. Allen JW. Lau FY. Percutaneous double balloon valvotomy for severe rheumatic mitral stenosis. Am J Cardiol 1990;65:473-7. Robertson JM, de Virgilio C, French W, Ruiz C, Nelson RJ. Fatal left ventricular perforation using mitral balloon valvuloplasty. Ann Thorac Surg 1990;49:819-21. Shawl FA, Domanski MJ, Yackee JM, Wish MH, Dullum M, Neimat S. Left ventricular rupture complicating percutaneous mitral commissurotomy: salvage using percutaneous cardiopulmonary bypass support. Cathet Cardiovasc Diagn 1990; 21:26-7. Al Zaibag M, Ribeiro PA. The future of balloon valvotomy. In: Top01 E. Textbook of interventional cardiology. ed. 1st Philadelphia: WB Saunders, 1990:1912-25. Vahanian A, Michel PL, Cormier B, Vitoux B, Michel X, Slama M, Sarano LE, Trabelsi S, Ismail MB, Acar J. Results of percutaneous mitral commissurotomy in 200 patients. Am J Cardiol 1989;63:847-52. Abascal VM, Wilkins GT, Choong CY, Block P, Palacious IF, Weyman A. Mitral regurgitation after percutaneous balloon mitral valvuloplasty in adults: evaluation by Doppler echocardiography. J Am Co11 Cardiol 1988,11:257-63. Vahanian A, Michel PL, Cormier B, Vitoux B, Roger V, Acar J. Mitral valvuloplasty: the French experience. In: Top01 E. Textbook of interventional cardiology. 1st ed. Philadelphia: WB Saunders, 1990:868-86. Vahanian A, Michel PL, Cornier B, et al. Results of percutaneous mitral commissurotomy in 200 patients. Am J Cardiol 1989;63:135-6. Manga P, Chun R, Horak M, et al. Balloon mitral valvuloplasty: multicenter study [Abstract]. Am J Cardiol 1989;63: 847-52. Pate1 J, Vythilingum S, Mitha AS. Balloon dilatation of the mitral valve by a single bifoil (2 x 19 mm) or trefoil (3 X 15 mm) catheter. Br Heart J 1990;64:342-6. Turi ZG, Reyes VP, Raju BS, Raju AR, Kumar DN, Rajagopal P, Sathyanarayana PV, Rao DP, Srinath K, Peters P, Connors B, Fromm B, Farkas P, Wynne J. Percutaneous balloon versus surgical closed commissurotomy for mitral stenosis: a prospective randomized trial. Circulation 1991;83:117985.
Moheeb Abdullah, MRCP, Murtada Halim, MRCP, Vijayaraghavan Rajendran, MRCP, William Sawyer, MD, and Muayed al Zaibag, FRCP. Riyadh, Saudi Arabia
The first successful percutaneous balloon mitral valvuloplasty was reported by Inoue et a1.l in 1984; these investigators used a single-balloon catheter designed for mitral valvuloplasty (Inoue balloon). A single balloon designed for peripheral arterial angioplasty had been used in the United States for mitral dilatation.2 Because the results were less than ideal (mitral valve area = 1.0 to 1.5 cm2) and the Inoue balloon was not commercially available, the single-balloon technique was soon replaced by the so-called “doubleballoon technique,” in which two balloon catheters (Mansfield Scientific, Mansfield, Mass.) were used. This institution began to use the double-balloon technique in 198L3 The procedure has subsequently become very well established as an alternative to the surgical treatment of severe rheumatic mitral stenosis.“-s Between January 1990 and May 1991, the Inoue single-balloon technique of mitral valvuloplasty also was used in 60 consecutive patients with severe rheumatic mitral stenosis (group B). The reFrom
the Riyadh
Received Reprint Riyadh
4/l/36248
Cardiac
for publication
Center,
Armed
Aug. 26, 1991;
requests: Dr. Moheeb Armed Forces Hospital,
Forces accepted
Hospital. Dec.
Abdullah, Department PO Box 7897, Riyadh
2, 1991. of Adult Cardiology, 11159, Saudi Arabia.
sults in this group of patients were compared with those in the first 60 consecutive patients with severe rheumatic mitral stenosis who had undergone double-balloon mitral valvuloplasty with a combination of 20 mm + 20 mm diameter balloon catheters (group A). The parameters compared were clinical improvement, mitral valve area achieved, technical failure, inadequacy of dilatation, complication rate, and ease of the procedure. METHODS
Between February 1987and January 1989,a total of 60 consecutive patients with symptomatic severe rheumatic mitral stenosisunderwent double-balloon mitral valvuloplasty with a combination of 20 mm + 20 mm diameter balloon catheters (group A). This combination of balloon catheter sizeswasdemonstratedby Zaibaget al9 to achieve the best result. Patient characteristics are shownin Table I. Atria1 fibrillation waspresent in nine patients (15% ). All of thesepatients, aswell asthe majority of the patients in sinusrhythm, received anticoagulation therapy (warfarin) for 8 weeksbefore the procedure. Nine patients (15%) had undergone previous surgical mitral valvuloplasty. Fortysevenpatients (78%) had no angiographic mitral regurgitation (MR), 12patients (20%) had MR grade l/4, and one patient had MR grade 214.No patient had MR grade 314 or 414 (Grossmanscale0 to 4). 1581
1582 Table
Abdullah et al. I. Patient baselinecharacteristics Group A
Group
Age range (yr)
16-17 33 k 10
14-63 34 + 12
32 28 l.l:l
17 43 0.4:1
B
Diameter (extra)
29 30 1 1.6
(48 % ) (50%) (2%) _t 0.2
23 34 3 1.6
(38%) (54%) (5%) k 0.2
47 (78%) 12 (20%)
38 (63%) 22 (37%) -
13 (22%)
10 (17%)
35 (58%)
44 (73%)
LISA, body surface area; NYHA,
New York Heart
Between January 1990and May 1991, a total of 60 consecutive patients underwent Inoue single-balloon mitral valvuloplasty for symptomatic severe rheumatic mitral stenosis(group B) (Table I). The size of the balloons used wasdetermined accordingto patient body surfacearea and height as shown in Table II. The maximum balloon diameter usedat full inflation ranged from 24 to 31 mm; 26 mm and 28 mm were the sizesmost commonly used.Atria1 fibrillation waspresent in six patients (10%); these patients together with 22 patients (37%) in sinus rhythm received warfarin for 8 weeksbefore the procedure. The six patients with atria1 fibrillation underwent transesophagealechocardiography in the 24 hours preceding the procedure. Ten patients (17%) had undergone previous surgical mitral valvotomy. Thirty-eight patients (63%) had no angiographic MR and 22 (37%) had MR grade 114.No patient in group B had MR that wasmore than grade l/4. There wasno significant difference between the two groups with regard to the degreeof MR before balloon mitral valvuloplasty. Comprehensivetwo-dimensionalechocardiography with spectral and color Doppler imaging was performed in all patients in both groupsbefore balloon mitral valvuloplasty, to ascertain the presenceof severerheumatic mitral stenosis,to determine the degreeof MR and the morphology of the mitral valve, to exclude left atria1thrombus, and to determine the presenceand degreeof other associatedvalve lesions. The exclusion criteria in both groups for balloon valvuloplasty were: left atria1 thrombus, MR more than grade 214,and other associatedvalve lesionsnecessitating surgery in their own right. The baseline characteristics of age, weight, body surface area, functional class, calcifica-
(mm)
Size
L
Male Female Ratio NYHA class II III IV Mean BSA (m2) Degree of angiographic MR No MR Grade l/4 grade 2/4 Fluoroscopic evidence of calcification (leaflet, commissures, or both) Other valve lesions (mild to moderate degree) MI?, Mitral regurgitation; Association.
II. Guidelines for selection of Inoue balloon size
Table
Characteristics
Mean(yr) Sex
June 1992 Heart Journal
American
M S ss
26-30 24-28 22-26 20-24
L, Large; h’, medium;
(31) (29) (27) (25)
Surface area
fm9 > = 1.9 > = 1.6 > = 1.3 <1.3
Height
(cm)
>180 >160 >147 = <147
S, small: SS. very small.
tion of the mitral valve, previous mitral valvuloplasty, and severity of mitral stenosiswere similar in both groups, although there were more malesin group A (p < 0.01). Procedure. Each patient signed an informed consent form for the procedure. All of the operatorsperforming the proceduresin group A were experienced and competent in the particular double-balloon mitral valvuloplasty technique used, which has been described previously.3 The Inoue technique hasalsobeen describedin detail15;a stepwise mitral valve dilatation technique was used. Pulmonary angiography with levophase was performed before transseptalpuncture to delineate the left atrium. Heparin, 150 units/kg, wasgiven immediately after the transseptal puncture. In both groups A and B, hemodynamic data were obtained from all patients before the balloon mitral valvuloplasty and at the conclusionof the procedure. These included transmitral valve diastolic gradient calculated by means of direct left atrium/left ventricle (LA/LV) pressures(except for one patient in group B with a St. Jude aortic valve prosthesis)and cardiac output determined by meansof the thermodilution method. The mitral valve area wascalculated by meansof the Gorlin formula. An oxygen saturation run wasobtained after balloon mitral dilatation to assessthe presenceof left-to-right shunt through any iatrogenic atria1septaldefect. Left ventricular angiography was performed in all patients before and after the procedure to assess the presenceand degreeof MR. Patients in group B had echo-Doppler studies after each inflation to assessmitral valve area, commissural split, and degreeof MR. Similar studies were performed in group A if the operator thought they were required. The echocardiography machinesused were Toshiba Sonolayer models SSH65A and SSHlGOA (Toshiba Corporation, Tokyo, Japan). Two-dimensional echocardiography with spectral and color Doppler imaging wasperformed in all patients within 24 hours of the procedure and at 24-hour and 6-week follow-up studies. The mitral valve area wasdetermined by
Doppler imaging according to the pressure half-time method describedby Hatle et al.1° The degreeof commissural split following the procedure was determined. The images were recorded pendent analysis.
on magnetic
tape for future
inde-
The symptomatic status of the patients-New York Heart Association (NYHA) functional class-was compared in both groups at 6-week follow-up studies.
Volume Number
123 6
Inoue versus double-balloon
LA
Fig. 1. Comparison of mean mitral sure) before and after percutaneous
valvuloplasty
1583
p~0.001
lM.Q#1
El
mitral
Dtwmm?
Post valvuloplasty
valve diastolic gradient (Gradient) and left atrial pressure (LA presbetween group A and group B. balloon mitral valvuloplasty
t&VA oma 2.5 P*Q.QQ?
P~O.001
1
T1.*0.3
21
Group A
P~Q.001
Tr.*ow
Group 3
1.893.4
Group A
RPPLER n
PI‘S vatvutq‘3fmy
Group 3
CIi”THETER I
Post
valv~loplasty
Fig. 2. Comparison of mitral valve area (MVA) measured by Doppler pressure half-time (Doppler) and Gorlin formula (Catheter) before and after percutaneousballoon mitral valvuloplasty betweengroup A and group B. Statistical analysis. Continuous variables are expressed as mean + standard deviation. Paired and unpaired t tests, together with chi-square or Fisher’s exact tests where appropriate, were used to analyze differences within and between the groups. RESULTS Hemodynamics.
The measured hemodynamic parameters showed significant improvement in both groups immediately after balloon valvuloplasty (Figs. 1, 2, and 3 and Table III). There was no significant
statistical difference in the final result achieved between group A and group B with regard to mitral valve area, mitral valve diastolic gradient, pulmonary artery systolic pressure, left atria1 pressure, and cardiac index. Technical failure. Technical failure-defined as the inability to advance the balloon across the mitral valve for various reasons-occurred in three patients (5 5%)in group A and two (3%) in group B. In group A one patient had cardiac tamponade after transseptal puncture before the insertion of the balloon. This
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Fig. 3. Comparisonof cardiac index before and after percutaneousballoon mitral valvuloplasty between group A and group B.
Table
III. Comparison of hemodynamic results before and after balloon mitral valvuloplasty in groups A and B Group
Hemodynamics Mean left atria1 pressure (mm Hg) Mean mitral valve diastolic gradient (mm Hg) Mean mitral valve area (cm2) Cardiac index (L/min/cm2) Pulmonary artery mean systolic pressure (mm Hg)
Before dilatation
A
Group
B
After dilatation
Before dilatation
After dilatation
22 f 4 14 f 4.5
12 jr 5* 4.5 + 2.3*
20 + 6 12.4 + 4.8
11 -t 3* 3.5 t 1.7*
0.9 + 0.5 2.3 + 0.5 46 k 16
2.1 i 0.5* 2.8 i. 0.5* 39 k 6*
0.8 +- 0.2 2.2 * 0.5 43 f 20
1.9 I 0.4* 2.4 + 0.5* 40 i- 17t
*p < 0.001. tp < 0.01.
patient underwent emergency surgery during which a hemorrhagic pericardial effusion was seen. Open mitral valvuloplasty was performed with no complications. In the other two patients, crossing the mitral valve with two balloons proved impossible. Both underwent open mitral valvuloplasty a few weeks later. In group B one patient had tamponade after transseptal puncture. Pericardiocentesis was performed in the cardiac catheter laboratory; after stabilization he underwent mitral valve replacement. In the other patient in group B, it was difficult to cross the atria1 septum with the balloon, and she underwent open mitral valvuloplasty a few weeks later. Inadequate dilatation. Inadequate dilatation-defined as a final mitral valve area of less than 1.5 cm2-occurred in two patients (3 % ) in each group. Of the two patients in group A, one had undergone pre-
vious mitral valvuloplasty in 1976; he had moderate calcification of the mitral valve. During the balloon mitral valvuloplasty there was imperfect alignment of both balloons across the mitral valve. The mitral valve area increased from 0.5 to 1.2 cm2 with mild MR. The patient improved symptomatically after balloon mitral valvuloplasty and was subsequently managed with medical therapy. The other patient had moderate calcification of the mitral valve, and the maximum mitral valve area achieved was 1.2 cm2. Because he continued to be symptomatic, open mitral valvuloplasty was performed. Of the two patients in group B, one with severe mitral stenosis (mitral valve area = 0.5 cm2) underwent stepwise dilatation with balloon diameters of 22, 24, and 26 mm, respectively; he had mild MR after the first dilatation and subsequently had moder-
Volume Number
123 6
Inoue versusdouble-balloonmitral valvuloplusty 1585 NYHA I
-
II
-
0
Pre-PTBMV
0
Post-PTBMV
III IV -
GROUP
A
GROUP
B
Fig. 4. Comparisonof New York Heart Association (NYHA) functional classbefore and after percutane-
ous transvenousballoon mitral valvuloplasty (PTBMV) between group A and group B (patients who underwent cardiac surgery were excluded).
ate MR (grade 2 to 3/4) with a final mitral valve area of 1.1 cm2. The degree of MR that developed caused the procedure to be abandoned at that stage; the patient underwent mitral valve replacement a few weeks later. The second patient had undergone previous mitral valvuloplasty and aortic valve replacement with a St. Jude valve in 1986. Despite use of the maximum balloon inflation size (31 mm diameter), the maximum valve area achieved was 1.1 cm2 with no MR. The patient then underwent the double-balloon technique with a combination of 20 mm + 20 mm balloon catheters; however, despite good alignment of both balloons across the valve, the valve area remained the same. He was then referred for cardiac surgery, and during the surgical procedure the mitral valve was found to be severely thickened, deformed, and fibrosed, and it was replaced with a St. Jude mechanical valve. Two-dimensional echocardiographic and Doppler studies. These studies were performed in both groups
on the day after balloon mitral valvuloplasty. The mitral valve area measured by Doppler imaging guided by color flow mapping increased from 0.9 f 0.2 to 1.9 -+ 0.3 cm2 (p < 0.001) in group A and from 0.9 ? 2 to 1.9 f 0.3 cm2 (p < 0.001) in group B. Both commissures were judged to be split adequately in 50 of 58 patients (86 % ) in group A and 54 of 59 patients (91% ) in group B. All of the patients who underwent mitral balloon valvuloplasty were reassessed6 weeks after the procedure, and two-dimensional echocardiographic and Doppler studies were performed at that time. The mitral valve area (1.9 + 0.2 cm2) and degree of MR remained the same in both groups. Complications. There were no procedure-related
IV. Comparisonof mitral regurgitation after percutaneousballoon mitral valvuloplasty betweengroupsA and B Table
Degree of MR No change One grade down One grade up Two grades up Three grades up Four grades up
MR.
Mitral
Group
A
34 (60%) 1(2%) 12 (21%)
5(9%)
Group
B
36(62%) 3 (5%) 14(24%) 3(5%)
p Value
>0.5 >0.5 >0.5 >0.5
2 (3%)
2 (3%)
>0.5
3(5%)
0
>0.5
regurgitation.
deaths in either group. No thromboembolic complications, loss of consciousness, or significant bleeding occurred in either group. Tumponade. One patient in each group had cardiac tamponade related to transseptal puncture. Both patients were stabilized and underwent open mitral valvulop!asty. Mitral regurgitation. Only five patients (8%) in group A and two patients (3 % ) in group B had moderately severe to severe MR (grade 3 to 4/4) (Table IV). Only one patient in group A required emergency mitral valve replacement for severe MR, inasmuch as he was hemodynamically unstable. The remaining four patients in group A and the two patients in group B were treated medically because they were not very symptomatic. Predilatation severity of mitral stenosis, degree of MR, calcification of the mitral valve, and patient age and sex were not found to be predictors of any postdilatation increase in MR. Atria1 septal defect. No patient in either group had
1588
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significant left-to-right (L:R) shunt-defined as L:R >1.4:1-after the procedure. Other complications. One patient in group A had a femoral arteriovenous fistula. Screening time. The mean screening time for diagnostic cardiac catheterization and balloon mitral valvuloplasty was 40 k 12 minutes in group A and 21 f 10 minutes in group B (p < 0.001). Cost. The charges for the disposable supplies used for balloon valvuloplasty in our hospital in groups A and B were 1870 and 2600 United States dollars, respectively. Clinical improvement. At the 6-week follow-up studies there was significant clinical improvement in both groups. All patients in group A were in NYHA functional class I or II compared to 45% before the procedure (p < 0.001). All patients in group B were in NYHA functional class I or II compared to 38% before the procedure (p < 0.001) (Fig. 4). DISCUSSION
Percutaneous transvenous balloon mitral valvuloplasty for symptomatic severe rheumatic mitral stenosis has achieved good results in many centers, proving the effectiveness and safety of the procedure.]+? The two techniques used principally are the Inoue procedure, which uses a specially designed single balloon, and the double-balloon technique. This study compared the results in 60 consecutive patients who underwent double-balloon mitral valvuloplasty with a combination of 20 mm + 20 mm balloons with findings in the first 60 consecutive patients who underwent the Inoue single-balloon technique. Although this study was not randomized, both groups had symptomatic severe mitral stenosis with similar baseline characteristics apart from sex distribution. Previously published comparisons between these two methods of balloon mitral valvuloplasty usually have been in disparate groups of patients.i’ The populations in these two groups had many of the same characteristics: both were relatively young and had pliable valves, although 13 o/oto 14 % of the valves were calcific. Thus a study comparing the results of balloon mitral valvuloplasties with a different technique in each of these two groups is valid. The patients in North American reports of mitral balloon dilatation are usually older and have more deformities of the mitral valve.12v l3 However, the known mechanism of balloon valvulotomy of the mitral valve, the closely matched success of the two techniques in our series, and the acceptable results reported by Feldman and Carrolli with the Inoue technique in older patients with deformed valves all
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would indicate that the overall results would probably be about the same for the two techniques in homogeneous North American populations. In this study equally good results were achieved when patients with severe rheumatic mitral stenosis underwent balloon mitral valvuloplasty by means of either the single- or double-balloon technique. After balloon mitral valvuloplasty there was significant improvement in the NYHA functional class in both groups, with an adequate and significant increase in mitral valve area and decreases in the transmitral valve pressure gradient, mean left atria1 pressure, and pulmonary artery systolic pressure, together with an increase in the cardiac index. There was no significant statistical difference between the two groups with regard to clinical or hemodynamic improvement. The mitral valve areas achieved in both groups were similar to results from other reported series that used either of the two techniques: Previously published results of double-balloon mitral valvuloplasty reported the achievement of mitral valve areas between 1.5 and 2.4 cm2 14; Inoue and Hung,15 on the other hand, reported achieving a mean mitral valve area of 1.97 ~fr0.04 cm3 in 527 patients with the use of a single-balloon technique. The incidence of technical failure was similar in both groups: 5% in group A and 3% in group B. The incidence of technical failure was 2.3 % in the Inoue series15 and 3% in the Vahanian series.23 In a similar study by Chen et a1.,16 comparing single- and double-balloon techniques, the success rate was higher (96 ‘% ) and the complication rate lower in the single-balloon group compared to the doubleballoon group. However, in that study the incidence of technical failure with the double-balloon technique was much higher (33%) than the usually accepted rate; this could possibly be due to the early learning phase of that group for the double-balloon technique. The incidence of inadequate valve dilatation was 3 ‘$Oin both groups A and B. The low incidence of inadequate dilatation in group A, compared to other studies in which the double-balloon technique was used (9% to 11%),20,23 is related to our use of large balloon size (20 mm + 20 mm). In both groups the balloon mitral valvuloplasty procedure produced very few complications, and there were no procedure-related deaths. Cardiac tamponade was the most serious problem encountered-with an incidence of 1.7% in both groupsand it only occurred as a result of transseptal puncture. Tamponade as a complication of transseptal puncture occurs in 1% -3% in large series.15* 17,‘1
Volume Number
123 6
Perforation of the left ventricle has been reported in less than 2% in the double-balloon mitral valvuloplasty technique. I7 The length of the Mansfield balloons and their sharp-tipped configuration contribute in some instances to ventricular perforation.18, lg This problem was not encountered in either group in this study. In group A this could be the result of the use of pigtail balloons, whereas in group B the special design features of the Inoue balloon results in a “fail-safe” movement away from the apex of the left ventricle toward the mitral valve, locking onto the mitral valve during balloon inflation, making the risk of left ventricular perforation very low.14, l6 After balloon mitral valvuloplasty the incidence of an increase in MR of one grade or more was similar in the two groups (36% in group A; 31% in group B), and this was similar to findings in other reported series (30% to 60%). 17,x 22 However, the incidence of moderately severe to severe MR was lower in group B, although it did not reach statistical significance: 8 70 and 3 % for groups A and B, respectively. An increase in MR of more than two grades occurs in 4% to 13 “0 in large series.17y 21,22 The lower incidence in group B may be attributable to the stepwise dilatation, which was made possible by the design of the Inoue balloon, and also to the use of echo-Doppler imaging after each dilatation to assess the commissural split, the mitral valve area achieved, and the degree of MR. The detection of any increase in MR would indicate that further dilatation would carry the risk of a further increase. Such stepwise dilatation and echo-Doppler assessment between each dilatation is not easily feasible with the double-balloon technique. In the double-balloon technique a major cause of MR, other than tear of the anterior or posterior leaflet, is chordae rupture, caused mainly by the malalignment or entanglement of the balloon catheters between the chordae. Chordae rupture is less likely to occur with the use of the Inoue single balloon, because the balloon is advanced across the mitral valve slightly inflated, functioning as a flow-directed catheter, thus decreasing the chance of entanglement in the chordae. Creation of an iatrogenic atria1 septal defect is an integral part of both procedures to pass the balloon from the right to the left atrium. In both groups there was no significant L:R shunt through an atria1 septal defect. The low incidence of atria1 septal defect in group A compared with that in other double-balloon series is a result of the use of two separate I4F transseptal sheaths through which the balloons are advanced into and pulled back from the left atrium. Also the low incidence of atria1 septal defect in
Inoue versus double-balloon
mitral
valvuloplasty
1587
patients in group B in our series compares favorably with the experience of others; Chen et a1.,i6 who used 14F dilators and the Inoue technique, similar to us, did not find a significant incidence of atria1 septal defect. The double-balloon technique involves two separate transseptal punctures with a 14F long sheath as described here or a single transseptal puncture with balloon dilatation of the atria1 septum and passage of two sets of balloon and wire devices across the atria1 septum, through the left atrium, across the mitral valve, and into the left ventricle. Positioning of the wires into the left ventricle leads frequently to ventricular dysrhythmia, resulting in hemodynamic disturbances. The Inoue technique, on the other hand, involves single transseptal puncture and single balloon dilatation of the mitral valve. Its special design allows the balloon to be stretched and “slenderized,” maintaining a low profile (4.5 mm), for passage across the atria1 septum. The Inoue balloon may be floated, similar to a flotation catheter, or directly steered into the left ventricle. The shorter inflation and deflation times (less than 3 seconds) and the lower inflation pressure (1 to 2 atm), compared to the slow inflation and deflation times and 3 atm pressure of conventional balloons, minimize the duration of hemodynamic disturbances.14r I5 The double-balloon technique is definitely more complex and cumbersome, and the mean screening time required is double that for the Inoue single-balloon technique. Inasmuch as one of the advantages of percutaneous balloon mitral valvuloplasty is the ability to repeat the process without the trauma of surgery, cumulative screening times must be regarded as an important potential risk. Few reports have been published on the use of bifoil or trefoil ballooned catheters to dilate the stenotic mitral valve.24* 25 The procedure is reported by Pate1 et a1.26to have a mean fluoroscopy time of 34 minutes, which approximates that for double-balloon mitral valvuloplasty. The procedure involves the use of a 10 mm diameter balloon catheter to dilate the transseptal puncture. Overall the single-catheter bifoil or trefoil balloon technique may have some advantages over the double-balloon technique, but its advantages if any over the Inoue single-balloon technique are minimal. In this series the cost to our institution of the disposable supplies used in the Inoue technique was 40 % more than the cost for the double-balloon technique, but we believe that these costs are justified in light of the ease with which the Inoue balloon catheter is used because of its special design features. Although the total cost of closed mitral valvotomy
1588
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may be lower than that of balloon mitral valvuloplasty in third world countries, the reverse is true in North America.27 The surgeons at this institution do not perform closed mitral valvotomy; however, the overall cost comparison would be closer to the North American ratio than the third world model. In conclusion, both the Inoue-single balloon and the double-balloon mitral valvuloplasty procedures are safe and effective nonsurgical modalities of treatment for severe rheumatic mitral stenosis in selected patients. Both techniques produce equally good results with a low incidence of complications. There was no significant difference between the two groups with regard to clinical or hemodynamic improvement, mitral valve area achieved, and rate of complications. The less complicated and easier Inoue singleballoon technique, although 40 % more expensive, justifies the extra cost involved. We thank Janice Clarke-Piccioni typing the manuscript.
and Marlene
Bernardino
for
REFERENCES
T, Kitamura F, Miyamoto N. 1. Inoue K, Owak T, Nakamura Clinical application of transvenous mitral commissurotomy by a new balloon catheter. J Thorac Cardiovasc Surg 1984;87:394402. 2. Lock JE, Khalilullah M, Shrivastava S, Bahl V, Keane JF. Percutaneous catheter commissurotomy in rheumatic mitral stenosis. N Engl J Med 1985;313:1515-8. 3. Zaibag MA, Kasab SA, Ribeiro PA, Fagih MR. Percutaneous double balloon mitral valvotomy for rheumatic mitral stenosis. Lancet 1986;1:757-61. 4. Babic UU, Pejcic P, Djurisic Z, Vucinic M, Grujicic SM. Percutaneous transarterial balloon valvotomy for mitral stenosis. Am J Cardiol 1986;57:1101-4. RG. Lock JE. Keane JF. Safian RD. Aroestv JM, 5. McKav Grossman W. Percutaneous mitral valvuloplasty in adult patients with calcific rheumatic stenosis. J Am Co11 Cardiol 1986;7:1410-5. 6. Palacios IF, Lock JE, Keane JF, Block P. Percutaneous transvenous balloon valvotomy in a patient with severe calcific mitral stenosis. J Am Co11 Cardiol 1986;7:1416-9. 7. Palacios IF, Block P, Wilkins G, Rediker D, Daggett W. Percutaneous mitral balloon valvotomy during pregnancy in a patient with severe mitral stenosis. Cathet Cardiovasc Diagn 1988;15:109-11. 8. Rediker DE, Block PC, Abasacal VM, Palacious IF. Mitral balloon valvuloplasty for mitral restenosis after surgical commissurotomy. J Am Co11 Cardiol 1988;11:252-6. PA, Al Kasab S, Halim M. Percutaneous 9. Zaibag MA, Ribeiro double-balloon mitral valvotomy: results using different sized balloon catheters. J Am Co11 Cardiol 1987;9:82A. 10. Hatle L. Aneelsen B. Tromsdal A. Non-invasive assessment of atrioventricmar pressure half-Time by Doppler ultrasound. Circulation 1979;60:1096-104.
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Heal
June 1992 Journal
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