December

Ribeiro et al.

American

ment of mitral orifice area in patients with mitral valve disease by real time, two-dimensional echocardiography. Circulation 1975;51:827-31. 17. Smith RO, Brender D, McCredie M. Percutaneous transluminal balloon dilatation of the mitral valve. Br Heart J 1989; 61:551-3. 18. Ribeiro PA, Zaibag MA, Rajendran V, Ashmeg A, Kasab S, Faraidy Y, Halim M, Idirs M, Fagih MR. Mechanism of mitral valve area increase by in-vitro single and double balloon mitral valvotomy. Am J Cardiol 1988;62:264-70.

Heart

1992 Journal

19. Mangione JA, Zuliani MF, Castillo JM, Nogueira EA, Arie X. Percutaneous double balloon mitral valvuloplasty in pregnant women. Am J Cardiol 1989;64:99-102. 20. Ribeiro PA, Fawzy ME, Arafah MR, Dunn B, Sriram R, Mercer E, Duran CMB. Comparison of mitral valve area results of balloon mitral valvotomy using the Inoue and double balloon technique. Am J Cardiol 1991;68:687-9.

Percutaneous mitral balloon valvuloplasty-a comparative evaluation of two transatrial techniques The efficacy and safety of two different percutaneous transfemoral mitral balloon valvuloplasty procedures were evaluated in 45 patients. A double-balloon technique with Mansfield balloons was applied in the first 22 patients (group A), and an lnoue single-balloon technique was used in the subsequent 23 patients (group B). Mean diastolic gradient decreased from 17 + 7 mm Hg to 8 + 3 mm Hg (p < 0.001) in group A and from 13 + 4 mm Hg to 8 + 3 mm Hg (p < 0.001) in group B. The mitral orifice area increased from 1.1 I 0.3 cm* to 2.2 + 0.8 cm2 (p < 0.001) in group A and from 1.2 + 0.4 cm2 to 1.7 + 0.7 cm2 (p < 0.001) in group B. The length of the total procedure and the total fluoroscopy time were considerably shorter in group B (88 f 24 minutes and 18 f 7 minutes) compared with group A (128 + 38 minutes and 35 f 14 minutes; p < 0.001). Mitral regurgitation (grade 3/4) was observed after the procedure in two patients in group A but in nine patients in group B. Cardiac tamponade occurred in two patients in group A, but no major complications were seen in group B. The lnoue single-balloon technique seemed to be safe, easier to perform, and equally effective. (AM HEART J 1992;124:1562.)

Wolfgang Kasper, MD, Helmut Wollschlager, MD, Annette Geibel, MD, Thomas Meinertz, MD, and Hanjorg Just, MD Freiburg, Germany

Percutaneous mitral balloon valvuloplasty has become a therapeutic option for patients with predominantly rheumatic mitral valve stenosis.l, 2 Different technical variants of the procedure have been described, but the risk/benefit ratios of these methods have not been compared. With increased use of percutaneous mitral balloon valvuloplasty, more patients are being considered as candidates for the procedure, and they often have a long history of disease,

From Received

the Innere

Reprint requests: Universittit, Innere 4/l/41293

1562

Medizin

for publication Wolfgang Medizin

III, Feb.

Albert-Ludwig+Universitiit 5, 1992;

accepted

Kasper, MD, III, Hugstetterstr.

Freiburg. June

Klinikum 55.7800

19, 1992. der Albert-LudwigsFreiburg, Germany.

nonpliable calcified valves, and atria1 fibrillation and are in New York Heart Association (NYHA) classes III and IV. Thus percutaneous balloon valvuloplasty has become more of a palliative procedure performed to postpone mitral valve replacement for several years. Under these conditions, the safety and efficacy of the procedure are of ultimate importance in gaining general acceptance. The present study was aimed at evaluating two commonly applied transatrial valvuloplasty techniques-the double-balloon technique3 and the Inoue single-balloon technique4-in terms of safety and efficacy. METHODS The study comprised and 4 men, aged 56 k

45 consecutive 13 years (range

patients, 41 women 27 to 83 years), with

Volume

124

Number

6

rheumatic mitral valve stenosis, in whom percutaneous mitral balloon valvuloplasty was performed at our institution between April 1987 and August 1990. Patients were considered for balloon valvuloplasty if they had a mitral valve orifice area 11.6 cm2, diagnosed by echocardiographic quantification (by direct planimetry from two-dimensional echocardiography and/or according to the pressure half-time method). A total of five patients had a mitral valve orifice area in the range of 1.4 to 1.6 cm’. Absence of both valvular vegetations and left atria1 thrombi had to be documented in all patients in terms of a transesophageal echocardiographic study immediately before the procedure. In addition, patients had to be anticoagulated for at least 6 weeks before balloon valvuloplasty. Patients were excluded if they had symptomatic coronary artery disease and more than moderate mitral regurgitation. Recently applied echocardiographic scoring of candidates for mitral balloon valvuloplasty was performed but was not, considered a prerequisite for recommendation or rejection of the procedure in our patients.5 Mitral valve calcification was graded semiquantitatively under fluoroscopic control as none (O), mild (l+), moderate (2+), or severe (3+). Patients were allocated to the two study groups in a nonrandomized, sequential manner. A transseptal, transatrial approach was used to dilate the mitral valve in all patients. The double-balloon technique with Mansfield balloons was used in the first 22 patients, whereas the single-balloon technique with the Inoue balloon was applied in the subsequent 23 patients. Matching of the balloon sizes to the mitral annular size was not attempted with either technique. Usually 20 mm and 18 mm balloons were used in those patients dilated with the double-balloon technique, and a 30 mm balloon was used with the Inoue technique. After transseptal puncture the interatria1 septum was dilated with an 8 mm single balloon in the double-balloon technique. When the Inoue balloon was used the interatrial septum was dilated with a 9F dilator. In the double-balloon technique two guide wires were placed in the left ventricle, which allowed passage of the two balloon valvuloplasty catheters into the mitral valve apparatus. After the Inoue balloon had been introduced into the left atrium, the catheter was filled with a small amount of contrast medium (Urografin) to allow the catheter to float over the valve into the left ventricle. When the balloons were positioned in the valve, they were inflated by means of one of the techniques until the impression of the commissures had disappeared or the balloons had reached their full circumference. Before and after the valvuloplasty procedure, a left ventricular angiogram and serial oxygen and hemodynamic measurements were obtained. Cardiac output was determined in trip. fe with the thermodilution technique. Left ventriculograms were evaluated for the presence of mitral regurgitation and quantitated according to the method of Sellers et a1.6 Follow-up of all patients was carried out for the first year after the procedure unless the patient died or surgical intervention became necessary for valvular heart disease. Clinical and Doppler echocardiographic data were received from the patients every 3 months on an outpatient basis. Statistics. Parameters were given as mean values rt

Mitral

1563

valvotomy by Inoue us double balloon

Table I. Clinical

characteristics

Clinical characteristics

Group A Double-balloon (n = 22) 54

Age (yr) Sex Male Female Heart rhythm Sinus rhythm Atria1 fibrillation Pacemaker History of Arterial emboli Operative commissurotomy Valvular calcification None Mild Moderate Severe Echo score NYHA class II III IV

of the patients

t

Group B Single-balloon (n = 23)

14

57

1 21

12

5

20 4 15 4

3 6

3 8

10 4 7

2

7.5 t 1.9

7.8

2 15 5

+

2.8

1 20 2

standard deviation. Results within the groups were evaluated by means of Student’s paired t test. Differences between the results obtained with the two valvuloplasty procedures were compared by means of Student’s nonpaired t test. A p value