Catheterization and Cardiovascular Diagnosis 26:323-326 (1992)

Preliminary Report lnoue Balloon Usefulness in Case Of Failureto Bifoil Catheter Balloons During Percutaneous Mitral Valvotomy p- Rochag MD,J* Berlandg MD,J.MmLefebvre,MD, P. Strumza, MD, P. Lacombe, MD, and F. Fernandez, MD A new bifoil balloon catheter has been used in the last 120 percutaneous mitral valvotomies carried out in our institution. The shaft segment between the two balloons of the bifoil catheter has been adjusted to the guide-wire diameter, allowing its introduction through a 14F sheath. This thinner shaft does not always offer enough back up to the balloons during inflation. An lnoue balloon replaced an unstable bifoil balloon in 5 cases of mitral dilatation failure due to balloon instability, regularly providing firm stability until full balloon inflation. 0 1992 Wlley-uu, Inc.

Key words: percutaneous mitral balloon valvotomy, Inoue's balloon, bifoll catheter-balloon


A new bifoil pigtail catheter-balloon [ l ] was used in 120 percutaneous mitral balloon valvotomies (PMBV). The procedure is simplified because the single shaft of this catheter (adjusted to a 0.038 guide-wire) carries 2 parallel balloons. However, the segment between the balloons often becomes too soft at 37°C and the balloons are sometimes propelled backward during inflation. As a result, mitral dilation may be inadequate or even technically impossible. This was the case in 5 procedures. The bifoil catheter was then replaced by an Inoue balloon: initial inflation of the distal extremity prevents it from sliding back into the left atrium. The purpose of this report is to present these 5 cases.

in the NYHA functional class 111. The end diastolic left ventricular volume index was 98 ml/m2, with left ventricular ejection fraction at 30%. Valvular aortic regurgitation was 2 + and there was no mitral regurgitation. Bifoil balloons had been clearly unstable during the first 4 inflation attempts. The fifth inflation seemed to be successful: balloons slid back only at the very end of inflation. Hemodynamic measurements showed a mitral valve area increase from 0.5 to 1.4 cm2. but this increase was not confirmed later by echography'(0.95 cm2). This result was considered unacceptable and a second PMBV attempt was carried out successfully 15 days later with a 30 mm Inoue balloon. The hemodynamic mitral valve area (HMVA) measured by Gorlin's formula was 2.0 cm'. A slight mitral regurgitation (1 + in Sellers' quotation) appeared. QP/QS was 1. Second Case Report

PMBV was carried out with an 18 + 18 mm bifoil catheter-balloon on a 61-year-old woman (body surface: 1.40 m2) in the NYHA functional class 11. Left ventricular end-diastolic volume index was 50 ml/m2 and a fibrotic funnel-shaped subvalvular apparatus seemed repeatedly to push the balloons back before their full inflation, despite the use of stiffer guide-wires. Hemodynamic mitral valve area increased slightly from 1.2 to 1.4 cm'. This result was considered insufficient because this patient was scheduled to receive cardiotoxic treatment for breast cancer. PMBV was successfully carried out 1 week later with a 28 mm Inoue balloon, which was stable at first attempt. HMVA was 2.1 cm2. A modest mitral regurgitation appeared after this procedure. QP/QS was 1.3. Third Case Report

A 40-year-old woman (body surface: 1.90 m2) in the NYHA functional class I1 had a PMBV with a 20 20



All patients had symptomatic mitral stenosis and an echographic area < ' 5 The PMBV procedure with bifoil balloon has been described previously [2]. Hemodynamic data are presented in Table 1.

From the Physiology and Cardiology Departments, Ambroise Pare Hospital, and Charles Nicolle Hospital, Rouen, and Clinique La Lou"ibre,. ill^,. F ~ ~ ~ ~ ~ ,

Received November 30, 1991; revision accepted March 1 I , 1992.

First Case Report

Address reprint requests to P. Rocha, Service d'Explorations Fonc-

An -I-20 mm bifoil catheter was used for a tionnelles, Hopital Ambroise Pari, 9av Charles de Gaulle, 92100 BouPMBV on a 20-year-old woman (body surface: 1.58 m2) Iogne, France. 0 1992 Wiley-Liss, Inc.


Rocha et al.

TABLE I. Hernodynamic Data (Pressures in mrn Hg)’

First case

Second case

Third case

(F, 20 y , 56 kg) 8/2b

(F,61 y. 46 kg)

(F. 40 y. 80 kg) 912

C LA MG HMVA (cm’) EMVA (cm2)






0.5 0.6

1.4 0.9


I I1 5 2.0 2.2

C 13

7 1.2 1.6



16 6 1.4 1.7

7 2 2.1 2.8

Fourth case (F, 41 y. 54 kg)

Fifth case (F, 61 y. 46 kg) 912











22 12





15 10


15 1.3

20 4


18 1.0 0.7

1.1 0.8

8 1.5

3 2.4 2.8



0.9 0.1

7 1.3

I >2.5 2.2

T.before dilation; B. after dilation with Bifoil balloons; I, after dilation with Inoue’s balloon; EMVA, echographic mitral valve area; HMVA, hemodynamic mitral valve area; LA, left atrium mean pressure; MG. mean transmitral pressure gradient; y, year old. bEcho score: Boston echographic anatomical score: total score (4 to 16) and subvalvular apparatus score ( I to 4).

m m bifoil catheter balloon. Once again, a funnel-shaped subvalvular apparatus propelled the balloons back into the left atrium, despite a normal left ventricular volume index at 64 ml/m2. Stiffer guide-wires did not stabilize the balloons. The hemodynamic mitral valve area increased from 1 . 1 to 1.5 cm2. This result was considered unsatisfactory for a woman weighing 80 kg and a second attempt was immediately carried out with a 30 m m Inoue balloon. This balloon was stable and the procedure was successful. HMVA was 2.4 cm2. QP/QS was 1.1.

tricular apex during systole despite a stiff guide-wire shored up against the left atrium contour. The hemodynamic mitral valve area increased from 0.9 to 1.3 cm2. Bifoil balloons were immediately replaced by a 28 mm Inoue balloon that was stable at first attempt (Fig. I). HMVA was impossible to calculate (mean mitral gradient: 1 mm Hg), probably > 2.5 cm2. QP/QS was 1.6. DISCUSSION

Achieving of satisfactory balloon stabilization across the mitral valve is sometimes difficult during PMBV. Twelve years after a surgical commissurotomy , The balloons may advance to the left ventricle apex, with PMBV was carried out with an 18 20 m m bifoil cath- consequent risk of perforation [3] if the catheter has a eter balloon on a 50-year-old woman (body surface: I .70 sharp point. Alternatively, the balloons may slide back m2) in the NYHA functional class 111. The distance be- into the left atrium, particularly when the subvalvular tween the left ventricular apex and the stenotic valve was apparatus is shortened and fused. Stability may be invery short. The end diastolic left ventricular volume in- creased by using pigtail tip catheter balloons advanced dex was 55 ml/m2 and the subvalvular apparatus, fibrotic over stiffer guide-wires. This allows the balloons to be and slightly calcified. Bifoil balloons were unstable, pushed firmly against the apex of the left ventricle, thus sliding back before full inflation in numerous attempts. maintaining the balloons across the mitral valve, with a Stabilization with stiffer wires was not tried and hemo- lower risk of perforation. However, when the mitral dynamic measurements showed a mitral valve area in- valve is funnel-shaped with reduced subvalvular space crease from I .O to 1.3 cm2. There was no mitral regur- (Fig. I ) , balloons are often pushed backward during sysgitation. Another PMBV was immediately performed tole by the left ventricular apex. One successful dilatawith a 30 mm Inoue balloon that was perfectly stable tion with an Inoue balloon replacing 2 standard catheter until full inflation. In spite of balloon stabilization, the balloons has already been described for a patient with mitral valve area increased only to 1.5 cm2 and an im- these anatomic features [4]; this patient had a high echoportant mitral valve regurgitation (3 ) appeared. QP/Qs graphic score [ 5 ] with a deformed subvalvular apparatus. This last feature was not the main cause of instability in was 1 . 1 . the present study, where only one out of five patients had more than trivial subvalvular impairment (Table I). InFifth Case Report stability was even more frequent with the bifoil balloons PMBV was carried out with an 18 18 mm bifoil because of their softer and more pliable distal shaft. catheter balloon on a 61-year-old woman (body surface: However, stability was always easily obtained with InI .40 m2) in the NYHA functional class 11. The end dia- oue’s balloon because of its specific design. In fact, first stolic left ventricular volume index was 45 ml/m2, with step inflation anchors the half-inflated balloon, when it an unusually short distance (3 cm) between the stenotic is pulled back. Subsequently, inflation of the proximal valve and the left ventricular apex in systole. Bifoil bal- balloon segment firmly stabilizes the now 8-shaped Inloons were unstable, clearly pushed back by the left ven- oue balloon in the stenotic valve. In the beginning of our Fourth Case Report




Balloon Instability in Mitral Valvotomy


Fig. 1. B,, Bifoil balloon partially inflated, immediately before the balloon is expelled back by left Ventricular systole. B,, Bifoil balloon partially inflated and supported by a stiffer guide-wire shored up against the left atrial contour. The diastolic left ventriculography image is here superimposed. B,, Bifoil balloon fully inflated. The systole left ventriculography is superim-

posed. The balloon is pushed back by the ventricular apex, despite stiff guide-wire back-up. I,, Distal lnoue balloon inflation. I, Partial lnoue balloon inflation. The &shape of the balloon grasps the stenotic mitral valve. l,, Full lnoue balloon inflation with successful dilation.

experience Inoue’s balloon was not available in our country; therefore, until 1990, mitral dilatation failure because of balloon instability always prevented percutaneous mitral stenosis treatment. The 5 cases presented here are related to the last 75 bifoil balloon procedures performed after 1990. Often, the stability of a bifoil catheter can be ensured by a stiffer guide-wire, but this is not without danger. In our first 280 PMBV there were 3 cases of tamponade with stiffer guides. In 1 of these 3 tamponades, in-catheterization laboratory pericardiocentesis turned out to be impossible by the usual transthoracic puncture because of an anterior pericardial symphysis due to a previous surgical commissurotomy [6]. From then on, we no longer tried to stabilize a slipping balloon with stiffer guide-wires in cases of prior surgical commissurotomy, such as the fourth patient. Balloon stability was promptly obtained for her with an Inoue balloon. Nevertheless, the procedure yielded a disappointing mitral valve area increase, and, in addition, created important mitral regurgitation. Valve damage might be

favored here by the cylindrical shape of Inoue’s balloon, which forces the entire valve rather than only the commissures. For the second and the fifth patients, there was clearly an incompatibility between the balloons and the anatomic valve features. The distance between the left ventricular apex and the stenotic valvular segment was too short: about 4 cm in diastole and less than 3 cm in systole. The distance from the tip of the pig-tail to the center of the balloons is 4 cm, and indeed, the balloon is unavoidably propelled back to the left atrium during left ventricular systole. This incompatibility is exaggerated by the fact that left ventricular filling decreases during balloon inflation. At present, we begin mitral dilatations directly with an Inoue balloon when the stenosis-systolic left ventricular apex distance is shorter than 4 cm. In conclusion, Inoue’s balloon seems to be an efficient alternative in cases of cylindrical bifoil balloon instability during percutaneous mitral valvotomy , especially when the left ventricle is small and the distance between its apex and a funnel-shaped valve is short.


Rocha et el.

ACKNOWLEDGMENTS We gratefully acknowledge the statistical and secretarial assistance of Anne-Marie Friedmann. REFERENCES I . Berland J , Choussat A, Fernandez F, Rocha P: Percutaneous mitral valvotomy using a new bifoil balloon. Circulation 80 (suppl 11): 358, 1989 (abstract). 2. Rocha P, Berland J , Rigaud M, Fernandez F, Bourdarias JP, Letac B: Fluoroscopic guidance in transseptal catheterization for percutaneous mitral balloon valvotomy. Cathet Cardiovasc Diagn 23: 172-176, 1991. 3. Berland J, Gerber L, Gamra H, Boussadia H, Cribier A. Letac B:

Percutaneous balloon valvuloplasty for mitral stenosis complicated by fatal pericardial tamponade in a patient with extreme pulmonary hypertension. Cathet Cardiovasc Diagn 17:109-111, 1989. 4. Benit E, Rocha P, De Gueest H, Van de Werf F: Successful mitral valvuloplasty using the Inoue balloon in a patient with mitral stenosis associated with subvalvular fibrosis and reduced left ventricular inflow cavity: A case report. Cathet Cardiovasc Diagn 22: 35-38, 1991. 5 . Wilkins G, Weyrnan AE, Abascal V, Block P, Palacios I: Percutaneous balloon dilatation of rnitral valve: An analysis of echocardiographic variables related to outcome and the mechanism of dilatation. Br Heart J 60:299-308. 1988. 6. Rocha P, Berland J, Pilliere R, de Groote T,Rath P, Remadi F, Bourdarias JP, Letac B: Pitfalls and complications in percutaneous mitral balloon valvotomy: Possible influence of the transseptal puncture level. Cardioavsc Imag 3:63-69, 1991.

Inoue balloon usefulness in case of failure to stabilize bifoil catheter balloons during percutaneous mitral valvotomy.

A new bifoil balloon catheter has been used in the last 120 percutaneous mitral valvotomies carried out in our institution. The shaft segment between ...
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