Catheterization and Cardiovascular Diagnosis 27:317-321 (1992)
Mitral Balloon Valvuloplasty With Transesophageal Echocardiography Without Using Fluoroscopy Hakan Kiiltiirsay, MD, Ciineyt Tiirkoglu, MD, Mustafa Akin, MD, Serdar Payzin, MD, Cahide Soydas, MD, and Azem Akilli, MD Balloon mitral valvuloplasty with lnoue technique was performed in two group of patients. In group I (n = 40) valvuloplasty was performed under fluoroscopy without using echocardiography, whereas in group 11 (n = 13) valvuloplasty was performed under the guidance of transesophageal echocardiographyalone, without using fluoroscopy. Patients In two groups were comparable with regard to clinical variables and hemodynamic parameters. Two female patients in group II were pregnant. Transmitral pressure gradient decrease did not differ significantly between two groups (pressure gradient: 17 f 5 to 4 1 in group I and 15 f 4 to 3 f 1 mm Hg in group ii). Mitral valvular area increase was also not different in two groups (1.09 f 0.2 cm2 to 2.3 0.5 cm2 in group I and 0.9 k 0.2 to 2 f 0.3 cm2 in group 11). In 14 cases from group I and 2 cases from group II mitral regurgitation increased after valvuloplasty (p < .05). Left atrial perforation occurred in one patient from group I and 2 patients from group II. In conclusion, mitral balloon valvuloplasty under transesophageal echocardiographic guidance alone is a safe and effective procedure in the treatment of mitral stenosis.
0 1992 Wlley-Liss. Inc.
Key words: mitral stenosis, balloon valvuloplasty, lnoue technique
Since its introduction in 1984 by Inoue et al. several reports have demonstrated the efficacy of mitral balloon valvuloplasty [ 11. Monofoil, two monofoil, bifoil, and Inoue balloons have been used, and they all have been found to be as effective as closed mitral commissurotomy. Echocardiography , particularly after the introduction of transesophageal echocardiography (TEE) has an important role in the diagnosis of valvular heart disease. TEE during mitral balloon valvuloplasty has also been shown to be a very useful imaging technique . From the Ege University, Medical School, Department of Cardiology, Bornova, Izmir, Turkey.
Received March 2, 1992; revision accepted June 1, 1992. Address reprint requests to Hakan Kiiitiirsay, M.D., 1716 Sokak 12/16, Karsiyaka, Izmir. 35600. Turkey.
0 1992 Wiley-Liss, Inc.
In this study we performed mitral balloon valvuloplasty (MBV) in two group of patients consequtively. In the first group (group I) MBV was performed with Inoue technique under fluoroscopy without using TEE. In the second group (group 11) MBV with Inoue technique was performed under the guidance of TEE alone, without using X-ray equipment. The aim of this study was to establish the safety and efficacy of MBV without using fluoroscopy and to compare the results of this group with the results of patients undergoing valvuloplasty with fluoroscopy. MATERIALS AND METHODS
Mitral balloon valvuloplasty was performed by using Inoue technique in both group of patients. In group I, MBV was performed in the catheterization room under fluoroscopy in usual manner . Balloons (Toray) in 26 to 30 mm size were used and dilatation was done in a stepwise fashion. In group 11, general anesthesia was used in 10 of the patients with endotracheal tubing, and in the remaining 3 patients only mild to moderate sedation with diazepam was used. The reason for using general anesthesia was to prevent sudden gagging and/or coughing of the patient during the attempt for septal puncture and to relieve the anxiety especially in pregnant patients. General anesthesia really yielded a quiet and comfortable setting for the procedure. The patients were prepared in a usual manner and procedures were performed in an operating room. A monoplane transesophageal transducer was introduced before the procedure and two chamber and four chamber multiple views of the heart was obtained. Basic Doppler and color Doppler images were taken before dilatation. The echocardiography system used was Hewlett-Packard Sonos 1000 with 5 mHz transesophageal transducer. After the venous and arterial sheaths were placed in the right groin a 0.032 inch exchange guidewire was advanced to the upper right atrium. After the guidewire was seen by TEE in the upper location in atrium, a transseptal Brockenbrough sheath-catheter system was advanced over this wire. Fossa ovalis was clearly and easily visualised. When the tip of the Brockenbrough catheter was oriented and slightly pushed against fossa, bulging of the interatrial septum to the left atrium was noted. After confirming the localization of catheter tip in different planes, puncture was done from this area. Once the sheath of the transseptal catheter system was entered in to the left atrium a flow directed balloon catheter was advanced through this sheath first to the left atrium and then to the left ventricle. Pressures were recorded. Then,
Kultursay et at.
Fig. 1. Echocardiographicview of guidewire in the left atrium.
a special guidewire of Inoue balloon system was placed into the left atrium. The distal loops of the guidewire were easily visualised in left atrium (Fig. 1). Interatrial septum was dilated with special Inoue dilator over this wire. Then, a Inoue balloon catheter was advanced to the left atrium under the guidance of echocardiography. The distal part of the balloon was slightly inflated. This inflation increased both the visibility and steerability of the balloon. After the balloon was positioned properly across the mitral valve it was fully inflated (Fig. 2). Pressures were recorded again following the dilatation, and colour Doppler recordings were repeated. Stepwise dilatation was also applied in this group, and at each step hemodynamic and echocardiographic parameters were evaluated before it was decided to go further. Student’s t test was used for comparison of numerical variables in two series. For the analysis of nonnumerical variables, the Chi square test was used.
9 years and ranged between 20 and 57. The etiology of mitral stenosis was rheumatic heart disease in all patients. There was no difference between groups in terms of age, functional class, echocardiographic score, and presence of valvular calcification (Table I). All of the patients were symptomatic with a mean functional capacity of 2.3 ranging between I and 111, according to the NYHA classification. There was mild mitral calcification in 12 patients. Atrial fibrillation was present in 10 patients. The incidence of atrial fibrillation was higher in group I . All the other patients were in sinus rhythm. Two patients had undergone closed mitral commissurotomy 3 and 20 years ago, respectively, in group 11. In group I, only 1 patient had undergone closed mitral commissurotomy 3 years ago. Mean echocardiographic score was 5.5 in group I. Mild mitral regurgitation was present in 7 patients. In three of these patients mitral regurgitation increased to moderate severity following the dilatation. Ten patients having no regurgitation before valvuloplasty in this group also developed mild regurgitation after the proceRESULTS dure. In one patient without regurgitation before dilataOur entire study group consisted of 53 patients (46 tion, moderate mitral regurgitation developed following female, 7 male). The mean age of the patients was 36 ? the procedure.
Mitral Valvuloplasty Without Fluoroscopy
Fig. 2. Echocardiographicview of the fully inflated balloon across the mitral valve. TABLE 1. Clinical Characteristics of Both Groups
Two female patients in group I1 were pregnant. The first patient was 32 years old, in the 7th month of her pregnancy. This was her second pregnancy. She had delivered her first child with cesarean section. Mitral valvular area was 0.7 cm2 and transmitral pressure gradient was 20 mm Hg in this patient. She was in functional class I1 with sinus rhythm. The second patient was 27 years old in the 4th month of her first pregnancy. She was in functional class 11. Mean transmitral pressure gradient was 16 mm Hg and valvular area was 1.3 cm2. In both of these patients Ritodrin HCl infusion was administered in order to suppress uterine contractions during procedure. Progesteron was also started in these patients before the procedure. Mean echocardiographic score was 5.4 in group I1 and it was lower than 8 in all patients. Mild mitral regurgitation was present in 3 patients before valvuloplasty. In one of these patients mitral regurgitation increased to a moderate degree following MBV. In one patient who did not have mitral regurgitation before dilatation, a moderate degree of regurgitation developed after the procedure. Echocardiographic score was 6 in both of these patients. In the other 9 patients there was no mitral regurgitation following MBV. Valvular area significantly
Clinical characteristics Age No. of women NYHA Atrial fibrillation Calcification Previous commissurotomy Echocardiographic score (mean) Complications Death Perforation (tamponade + ) Perforation (tamponade - ) Duration of procedure
Group 11 without fluoroscopy (n = 13)
Group 1 with fluoroscopy (n = 40)
36 9 (20-57) 36 (90%) 2.3 9 patients 10 patients (25%) 1 patient (3 years ago)
35 f 1 1 (20-56) 10 (77%) 2.4 1 patient 2 patients (15%) 2 patients (3 and 20 years ago)
1 patient 45 minutes
I patient 58 minutes
increased in all patients following the procedure (1.09 ? 0.2 an2 to 2.3 ? 0.5 cm2 in group I, and 0.9 ? 0 . 2 to 2 2 0.3 cm2 in group 11). Valvular area after the dilatation was slightly larger in group I but this was not significant statistically. Transmitral pressure gradient and
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TABLE II. Hemodynamic Parameters in Two Series Before and After the Procedure* Group I MVA (an2)
2.3 ( 2 0.5)
( * 0.2)
LA pressure (mean mm Hg) Pressure gradient
( * 6)
17 (+ 5)
4 ( 2 1)
15 ( * 4)
I? 2) 3
( * 1)
(mm Hg) *MVA: mitral valvular area; LA = left atrial pressure.
TABLE 111. Mitral Regurgitation Before and After the Procedure in Both Groups Group I
0 111 0
4 I11 0
left atrial pressure also decreased significantly after valvuloplasty without significant difference between groups (pressure gradient: 17 ? 5 to 4 _t 1 in group I and 15 2 4 to 3 ? 1 mm Hg in group 11, mean left atrial pressure: 24 ? 6 to 1 1 _t 2 in group I and 24 ? 9 to 12 ? 2 mm Hg in group 11). Duration of the procedure was slightly longer in the second group (Table I). In two patients in group I1 left atrial perforation occurred. In one of these patients perforation occurred during the dilatation of interatrial septum with the perforator of Inoue balloon system. This patient was followed for 1 day in the intensive care unit. Leaking into the pericardial space was self limited and on the following day MBV was performed successfully with fluoroscopic guidance. In the second patient left atrial perforation occurred during the advancement of Inoue balloon through the septum. Cardiac tamponade developed and the patient was transferred to surgery for open comissurotomy . Left atrial perforation occurred in one patient from group I who required surgery. DISCUSSION
MBV is widely used in the treatment of mitral stenosis. Mitral balloon valvuloplasty under the guidance of transesophageal echocardiography without using X-ray equipment was performed for the first time by ourselves
as far as the related literature is reviewed. The usefulness of TEE during septal puncture is very well documented by several groups [4,51. The use of this method during MBV is also very helpful [ 6 ] . It is used to determine correct localization of septal puncture site. Septa1 puncture site is crucial in MBV. If the puncture is done from an upper level in septum the manipulation and orientation of balloon catheter through septum into the left ventricle becomes a problem. Puncture from the correct site requires more than one attempt very frequently. This may cause multiple holes in the septum or even perforation of right atrium, which may lead to bleeding into the pericardial space. The most dangerous point in our opinion is to make the puncture in a very upper level in septum. In this situation the possibility of perforating the left atrial wall during the dilatation of septum or passage of balloon catheter is high and increased left atrial pressure may cause cardiac tamponade in a very short time. This complication can be seen even in the most experienced centers. In two of the patients from group 11, this complication occurred. In both patients septal puncture site was high in the septum. Some part of the left atrium near the puncture site was poorly visualised. In one of these patients perforation occurred close to the puncture site during the dilatation of the septum with the dilator of Inoue balloon system. In the second patient perforation occurred when the Inoue balloon was advanced to the left atrium through septum. Perforation point was in the upper wall of the atrium. We believe that perforation would have been avoidable in both patients if the puncture was done in lower level in septum. Another problem in MBV can be the proper positioning of the balloon catheter across the valve. Mitral valve is not visible under fluoroscopy if there is no calcification. On the other hand, calcific valves are not ideal for balloon valvuloplasty. Mitral valvular apparatus is clearly seen by TEE. For this reason, TEE has been used increasingly in recent years during MBV. In a certain group of patients with high echocardiographic score, TEE was used in our laboratory as well, during mitral balloon valvuloplasty with fluoroscopy. We first tried to use bifoil balloon for MBV but the visualisation of this balloon and guidewire by TEE was poor and insertion of the balloon over the guidewire into the left ventricle was very difficult. On the other hand, by proper positioning of the transesophageal probe, it was easy to locate and advance the Inoue balloon in the left atrium, toward the mitral valve, particularly when it was slightly inflated. The use of biplane TEE can probably make better the visualisation of balloon catheter and placement across the mitral valve. Another advantage of using TEE during MBV is the possibility of evaluating the result immediately after di-
Mitral Valvuloplasty Without Fluoroscopy
latation. The opening of mitral leaflets are clearly seen, and echocardiographic transvalvular gradient can be correlated with pressure recordings. Doppler and color Doppler evaluation of mitral regurgitation can be done without ventriculography. This will save time and eliminate the necessity to use contrast material. When the two groups were compared with regard to development of mitral regurgitation at least one degree after procedure, the incidence was significantly higher in group I. The lower incidence in group I1 can be explained by better and immediate evaluation of valvular opening and competence by means of TEE. The first reason for performing MBV under the guidance of TEE alone is that it enables avoidance of X-ray irradiation both for patient and operators. During this procedure under fluoroscopy both operators and patient are exposed to considerable X-ray irradiation. Fluoroscopy time and thereby irradiation during interventional procedures is at least three times greater than diagnostic studies [7-91. This is particularly important for the performance of MBV in pregnant female patients. The physicians are also especially affected because of frequent procedures. The second reason was to determine the feasibility of performing this procedure outside the catheterization laboratory, which can then be reserved for other procedures. This is cost-effective and lowers the cost of MBV. In our study, the patient population in the two groups is quite similar. When the results are compared between groups there is not a statistically significant difference. Complication rates were also not significantly different between two groups. Left atrial perforation in two patients in the second group occurred in the first 6 cases at a relatively less experienced stage. It is possible to avoid this complication by properly determining the correct puncture site in septum.
In conclusion, although the case number is limited, the results of this study show that MBV with TEE alone is a feasible and safe procedure. In the near future, further developments and better results in this technique may ultimately eliminate the neccessity of using a catheterization laboratory and MBV can be performed outside the invasive laboratory on a routine basis.
REFERENCES 1. Inoue K, Owaki T, Nakamura T , Kitamura F, Miyamoto N: Clinical applications of transvenous mitral commissurotomy by a new balloon catheter. J Thorac Cardiovasc Surg 87:394-402, 1984. 2. Erbel R, Khandheria B, Brennecke R, Meyer J , Seward J, Tajik J: “Transesophageal Echocardiography,” 1st Edition. Berlin: Springer-Verlag, 1989, pp 244-250. 3. Inoue K, Hung JS: Percutaneous transvenous mitral commissurotomy (PTMC): The far east experience. In Topol EJ: “Textbook of Interventional Cardiology,” 1st Edition. Philadelphia: WB Saunders Company, 1990, pp 887-899. 4. Ballal RS, Mahan EF, Nanda NC, Dean LS: Utility of transesophageal echocardiography in interatrial septa1 puncture during percutaneous mitral balloon commissurotomy . Am J Cardiol 66(29): 230-232, 1990. 5 . Casale PN, Whitlow P, Cunie PJ, Stewart WJ: Transesophageal echocardiography in percutaneous balloon valvuloplasty for mitral stenosis. Cleve Clin J Med 56(6):597-600, 1990. 6. Orihashi K. Matsuura Y, Ishihara H, Hamanaka Y, Kawaue Y, Sueda T, Kanehiro K, Nomimura T, Okamoto M, Tscuchioka Y, Inoue K: Transvenous mitral commissurotomy examined with transesophageal echocardiography. Heart Vessels 3:2O9-2 13, 1987. 7. Meier B: “Coronary Angioplasty,” 1st Edition. Orlando: Grune and Stratton, Inc., 1987, pp 30-32. 8. Miller SW, Castronovo FP: Radiation exposure and protection in cardiac catheterization laboratories. Am J Cardiol 55: 171-176, 1985. 9. Raphael MJ, Tomlinson NE: Radiation hazards for cardiologists. Br Heart J 55:421-422, 1986.