Comparison of single rubber-nylon balloon and double polyethylene balloon valvuloplasty in 94 patients with rheumatic mitral stenosis TO compare the single rubber-nylon balloon and double polyethylene balloon techniques, 94 patients with rheumatic mitral stenosis underwent percutaneous transseptai balloon mitral valvuloplasty between November 1985 and September 1988. The single balloon technique was used in 73 patients and the double balloon technique was used in 21. The two groups were similar in age, weight, severity of the lesion, and cardiac functional status. The mean mitral valve diastolic gradient decreased from 17.9 • 6.5 to 2.9 • 3.1 mm Hg (p < 0.001), 18,5 • 6.7 to 5.8 _+ 3.1 mm Hg (p < 0.001), and 18.1 • 5.9 to 3,2 • 3.7 mm Hg (p < 0.001) in the single balloon group, double balloon group, and the entire series, respectively. The final mitral diastolic gradient in the single balloon group was lower than in the double balloon group (p < 0.05). Complications in the single balloon group were lower than in the double balloon group. Additional advantages of single over double balloon technique were easier maneuverability and higher success rate. The initial and long-term follow-up results confirmed the earlier impressions that percutaneous transseptal balloon mitral valvuloplasty is an effective and safe nonsurgical method of treatment for rheumatic mitral stenosis, and the single rubber-nylon balloon technique is at least as effective as, if not superior to, the double polyethylene balloon technique. (AM HEART J 1990; 119:102.)

C h u a n Rong Chen, MD, Zhen Dong Huang, MD, Zheng X i a n g Lo, MD, and T s u n g O. Cheng, MD.

Guangzhou, China, and Washington, D.C.

Since the initial description of p e r c u t a n e o u s transvenous mitral c o m m i s s u r o t o m y by a balloon catheter from J a p a n in 1984,1 m a n y studies from other parts of the world have confirmed the effectiveness of this technique in relieving rheumatic mitral stenosis with minimal m o r t a l i t y and acceptable complication rates. 2-16 In the majority of these studies, a single balloon was used. More recently, there has been an increasing t r e n d toward using a double-balloon technique.6, s, 15, 17-22 A l t h o u g h a trefoil-shaped balloon has been tried, 1~it is seldom used at present because of a t e n d e n c y to kink and t h u s p r e v e n t full deflation. In this r e p o r t we describe our experience in 94 patients with r h e u m a t i c mitral stenosis (MS) a n d compare the results achieved with the single rubbernylon balloon (SRB) and double polyethylene balloon (DPB) techniques. From the Departments of Cardiologyand CardiovascularSurgery,Guangdong ProvincialCardiovascularInstitute, Guangzhou.China:and the Department of Medicine.The GeorgeWashingtonUniversitySchoolof Medicine and Health Sciences,Washington,D.C. Received for publication July 21. 1989:acceptedSept. 5. 1989. Reprint requests:Tsung0. Cheng,MD.The GeorgeWashingtonUniversity Medical Center. 2150PennsylvaniaAve.,N.W., Washington,DC 20037. 4/1/16742

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METHODS Patient population. From November 1985 to September

1988, 94 patients with MS underwent percutaneous transseptal balloon mitral valvuloplasty (PTBMV). The mean age of this study series was 33.8 (range, 15 to 56) years. There were 25 males and 69 females. The duration of illness was 7.3 years (range, 4 months to 24 years). The New York Heart Association (NYHA) functional class was II in 42 patients, III in 51. and IV in 1. One patient (1%) had associated tricuspid stenosis, 22 three (3%) had associated mild mitral regurgitation (MR), 13 (14%) had associated mild aortic regurgitation, two (2%) had associated small pericardial effusion, and 25 (27%) had associated mild to moderate calcification of the mitral leaflets and/or commissures. In addition, there was associated pulmonary emphysema in one patient and duodenal ulcer in another. The chest x-ray films showed a cardiothoracic ratio of greater than 50% in 54 patients (57 % ). left atrial enlargement in 94 (100%), right ventricular enlargement in 87 (93%), and prominent pulmonary artery trunk in 76 (81%). The electrocardiograms showed sinus rhythm in 84 patients (89 % ), atrial fibrillation in 10 fll % ), left atrial enlargement in 71 (76%), and right ventricular enlargement in 32 (34 % ). On the basis of the number and type of the balloons used, our entire series was divided into two consecutive groups: SRB in 73 patients and DPB in 21 patients. Before December 1987, only SRB was used. The age, sex, weight,

Volume 119

Single vs double balloon mitral valvuloplasty

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Fig. 1. Mitral valve diastolic gradient before (top) and after dilatation with a 2 x 19 m m bifoil balloon (middle) followed by a 27 m m rubber-nylon balloo n (bottom} in a 30-year'old m a n with rheumatic mitral stenosis. LA, Left atrial pressure; LV, left ventricular pressure.

cardiac functional class, duration of illness, and severity of mitral stenosis were similar in both groups. Technique of balloon valvuloplasty. The SRB technique for P T B M V was as described previously from our cardiac catheterization !aboratory. 12 More recently, we employed an 8F Mullins transseptal set (USCI Division, C.R. Bard, Billerica, Mass.) in place of the Brockenbrough catheter and a 14F long dilator in place of the ! 6 F size. The balloon size was 23 to 29 m m in diameter with a mean of 26.4 mm. The manUal inflation pressure was 1 to 2 atm for 3 seconds until the "waist" disappeared. 12 after the first 30

patients catheterized before 1987,12 we encountered no difficulty with advancing the balloon catheter from the left atrium to the left ventricle. The D P B technique for P T B M V was basically similar to the SRB technique. After the Mullins transseptal set was advanced into the left atrium, the transseptal needle was removed and 150 units/kg of heparin was given Via the Mullins dilator. A 7F pigtail catheter (Cordis Corp., Miami, Fla.) was inserted percutaneously through a 7F side-port sheath (Cordis Corp.) t h a t was previously placed in the right femoral artery and was advanced into the left ventri-

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January 1990 American Heart Journa!

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cle. Following the measurement of the diastolic gradient across the mitral valve, the Muilins dilator was withdrawn. After a 0.038-inch diameter stylet with a special handmade curve at the distal end with the aid of a heavy-duty guide wire (Cook Australia, Brisbane, Australia) was inserted all the way into the Mullins sheath, the latter was advanced from the left atrium to the left ventricle with a counterclockwise rotation of the stylet. The latter was exchanged for a 260 cm 0.038-inch diameter exchange guide wire (C0rdis Corp.) with a preshaped curl at its tip that was placed in the left ventricle. A seCond 0.038-inch diameter exchange guide wire was similarly placed in the left ventriCle via the Mullins sheath, which was then removed. An 8 mm balloon catheter (Mansfield Scientific Co., Mansfield, Mass.) was inserted over one of the exchange guide wires into the left atrium, the balloon was inflated and pulled across the interatrial septum to enlarge the transseptal puncture opening, and the catheter was removed. A 14-inch French dilator was inserted over the same exchange guide wire into the femoral vein for dilation of the percutaneous puncture opening and was then removed. Two polyethylene balloon catheters (Cook CO. or Mansfield Scientific) were advanced, one over each exchange guide wire, from the left atrium across the mitral valve into the left ventricle. For the bifoil polyethylene balloon catheter (Schnei' der-Shiley, Zurich, Switzerland) only one exchange guide wire was utilized. The balloon sizes were 20 + 20 mm in 10 patients, 23 + 15 mm in two, 18 + 15 mm in one, and 2 • 19 m m bifoil in four, The manual inflation pressur e was 3 to 4 atm for 6 to 10seconds simultaneously until the "waist" disappeared. Inflation was repeated once or twice and the

balloon catheters were pulled back to the left atrium. One balloon catheter was exchanged for a 65 cm 7F pigtail catheter (Cordis Corp.) and the other balloon catheter was removed. Cardiac auscultation was carried out frequently during the procedure by the same examiner for detection of any changes in the heart sounds or for detection of murmurs. Phonocardiograms were recorded both before and after the procedure. Repeat measurements of mitral diastolic gradient, left atrial pressure, pulmonary arterial pressure, and thermodilution cardiac output were performed. Left atrial angiography and right heart oximetry were performed for detection of a left-to-right shunt at the atrial level. Left ventriculography was performed if necessary for assessment of MR. At the conclusion of the procedure, all catheters and sheaths were removed. Hemostasis over the right groin was achieved with hand pressure for 20 to 30 minutes and was maintained with a 4 kg sandbag for 6 hours. Seventy-five milligrams of dipyridamole, 150 mg of aspirin, and 1.6 million units of penicillin G were given for 3 days. RESULTS Single versus double balloon technique. In the SRB g r o u p the p r o c e d u r e was d i s c o n t i n u e d in one p a t i e n t because of failure of the balloon to traverse the severely stenotic m i t r a l orifice. In two p a t i e n t s the p r o c e d u r e was t e r m i n a t e d before insertion of the balloon c a t h e t e r because of atrial wall injury b y t h e B r o c k e n b r o u g h c a t h e t e r in one with r e s u l t a n t cardiac t a m p o n a d e , a n d b y injury f r o m the Brockenb r o u g h needle in a n o t h e r w i t h o u t cardiac t a m p o n ade. T h u s the success r a t e was 96% (70 of 73). In t h e D P B g r o u p t h e p r o c e d u r e was discontinued in seven p a t i e n t s because of unsuccessful t r a n s s e p t a l p u n c t u r e due to severe m a l f o r m a t i o n of the inferior v e n a cava in one, cardiac t a m p o n a d e following t r a n s septal p u n c t u r e in two, failure of t h e balloon catheter to enter the left ventricle in two, failure of the Mu!lins t r a n s s e p t a l set to cross t h e interatrial sept u m in one, and failure of the i n t r o d u c e r to e n t e r the skin p u n c t u r e site in another. In the l a s t four p a t i e n t s the S R B t e c h n i q u e was s u b s e q u e n t l y used with satisfactory results. In addition, one p a t i e n t after an unsuccessful 23 + I5 m m D P B dilation u n d e r w e n t successful v a l v u l o p l a s t y with a 2 • 19 m m bifoil balloon. On the o t h e r hand, in a n o t h e r p a t i e n t signific a n t h e m o d y n a m i c i m p r o v e m e n t was o b t a i n e d with a 27 m m S R B following an initial less-than-satisf a c t o r y 2 • 19 m m bifoil balloon valvuloplasty (Figs. I a n d 2). T h e duration of the p r o c e d u r e in the S R B g r o u p was m u c h shorter t h a n in the D P B group. In m o s t of t h e p a t i e n t s in the S R B group it t o o k only 15 to 25 m i n u t e s f r o m the s t a r t of the t r a n s s e p t a l p u n c t u r e to t h e c o m p l e t i o n of successful balloon m i t r a ! valvutoplasty.

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Single vs double balloon mitral valuuloplasty 105 mm Hg

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