Balloon Catheter Test in Patients with Atrial Septal Defect and Patent Ductus Arteriosus

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1 Balloon Catheter Test in Patients with Atrial Septal Defect and Patent Ductus Arteriosus Takeo SAKURAI, M.D., Hideaki HOSHINO, M.D., Yoshio SUZUKI, M.D., Hideki YOKOI, M.D., Kozo SAKANAKA, M.D., Katsumi ENOMOTO, M.D., and Naniwa OKADA, M.D. SUMMARY Since 1973, the balloon catheter test with a Swan-Ganz, Dotter- Lukas or Fogarty catheter has been attempted in our department in cases of atrial septal defect (ASD) and patent ductus arteriosus (PDA) during cardiac catheterization and operation. Accurate informations concerning size, number and location of ASD were obtained during cardiac catheterization studies by using the balloon catheter. The difference between the size of the defect measured at catheterization and at operation was less than 1mm in diameter. Size of the defect ranged from 13 to 44mm in diameter (25.7mm on the average) and became larger with patient's age. Measurement of left-to-right shunt ratios before and after the temporary balloon occlusion of the defect was of help in making a preoperative diagnosis of ASD with multiple defects. Size of foramen ovale ranged from 3 to 13mm in diameter (5.2mm on the average) and was not related to age. Size of the ductus in cases with PDA was measured during cardiac catheterization by using the balloon catheter. The difference between the size of the ductus measured with the balloon technique at catheterization and with a measuring rule at operation was less than 4mm in diameter. The difference revealed the extensibility of the ductus. The temporary balloon occlusion of the ductus aided in determining presence of other cardiac anomalies. In cases of isolated PDA, the murmur became inaudible with the occlusion of the ductus. A balloon catheter inflated with radiopaque dye was used for measurements at cardiac catheterization and at operation. Persistent arrhythmias or other adverse effects of this procedure were not observed. Additional Indexing Words: Cardiac catheterization Temporary balloon occlusion Size Shunt ratio From the Department of Thoracic Surgery, Wakayama Medical College, Wakayama. Address for reprint: Takeo Sakurai, M.D., Department of Thoracic Surgery, 7-Bancho, Wakayama 640, Japan. Received for publication January 19, Manuscript revised June 20,

2 780 SAKURAI, ET AL. Jpn. Heart J. November, 1980 number of catheter techniques have been used for treatments of congenital heart disease. Foremost were Rashkind and Miller's1) efforts at palliating transposition of the great vessels by balloon atrioseptostomy. In the same year, Porstmann and associates2),3) successfully closed PDA by using a transfemoral catheter. Nonoperative closure of the secundum atrial septal defect was also reported in 11 patients.4)-7) For the first time, Varnauskas and associates8) measured size of the defect during cardiac catheterization by using a balloon catheter in one case of ASD in 1954, but since then no report of its use has been reported. This paper describes balloon catheter tests during cardiac catheterization and operation in cases of ASD and PDA. MATERIALS AND METHODS Group 1: ASD 1) Since 1973, 70 patients have had defects measured with the balloon catheter test during cardiac catheterization. Forty of 70 patients had a diagnosis of ASD at cardiac catheterization while the remaining 30 patients had a diagnosis of patent foramen ovate (Table I). In ASD, patients ranged in age from 3 to 63 years and there were 23 female and 17 male patients. In patent foramen ovale, patients ranged in age from 2 to 17 years and there were 15 female and 15 male patients. A balloon catheter (Swan-Ganz, Dotter-Lukas, or Fogarty catheter) was introduced through the right femoral vein. The catheter consisted of a single lumen with a deflated balloon near the distal tip. After the balloon catheter was advanced into the left atrium through the defect, it was inflated with 50% sodium diatrizoate. A radiopaque solution more concentrated than 50% was difficult to remove from the balloon. Care was taken to remove all air from the balloon before inflating it in the heart. The inflated balloon catheter was then withdrawn from the left to the right atrium repeatedly, increasing the volume of the balloon, until it just fitted the defect so that it might encounter the resistance of the septum (Fig. 1). From the volume of solution in the balloon, the diameter of the defect was calculated with use of a nomogram (Fig. 2). For a small defect less than 15mm in diameter, a Swan-Ganz catheter was appropriate and for one less than 24mm in diameter, a Dotter-Lukas catheter was used. For a larger defect (for example, one with a diameter of 25 to 40mm), a No French Fogarty catheter was appropriate and for one greater than 40mm in diameter, a No.8-22 French Fogarty catheter was used. 2) Prior to the temporary balloon occlusion of a defect, an oximeter cathether was inserted through the cephalic vein, advanced to the pulmonary artery and positioned (Fig. 3). Pulmonary arterial oxygen saturation and pressure were continuously measured before and during the defect occlusion in 13 of 40 patients with the diagnosis of ASD. Left-to-right shunt ratio, pulmonary to systemic flow ratio, pressure ratio and resistance ratio were calculated. Group 2: PDA Cardiac anomalies associated with PDA are sometimes missed with usual car-

3 Vol.21 BALLOON CATHETER TEST 781 No.6 Table I. Balloon Measurement of ASD in 40 Patients and Foramen Ovale in 30 Patients Continued to the next page

4 782 SAKURAI, ET AL. Jpn. Heart J. November, 1980 Table T. Continued. (A) FO=foramen ovate; VSD=ventricular septal defect; PS=pulmonic stenosis; DORV=double outlet right ventricle; TF=tetralogy of Fallot; ASD=atrial septal defect

5 Vol.21 BALLOON CATHETER TEST 783 No.6 Fig. 1. Balloon catheter test in a case of ASD. The filled balloon catheters are present in the left (A) and right (B) atrium. diac catheterization studies. Since 1973, the balloon catheter test with a Swan- Ganz or Dotter-Lukas catheter has been used in cases of PDA. After the diagnosis of PDA was established by cardiac catheterization, a balloon catheter was inserted through the right femoral vein and advanced across the ductus to the aorta. After the balloon catheter was inflated with 50% sodium diatrizoate in the aorta, the inflated balloon was withdrawn across the ductus to the pulmonary artery (Fig. 4). Size of the ductus was thus measured exactly. Balloon measurement of the ductus was carried out in 11 patients (Table II). The patients ranged in age from 4 months to 20 years. There were 9 female and 2 male patients. With the temporary balloon occlusion of the ductus, examination was conducted to determine if the continuous murmur became inaudible. RESULTS Group 1: ASD 1) Of 40 patients with ASD diagnosed by cardiac catheterization studies from 1973 to 1978, 31 patients underwent operation. The difference of the size of the defect measured at catheterization and at operation was less than 1mm in diameter (Table I). Size of the defect ranged from 13 to 44mm in diameter (25.7mm on the average). In 30 of 40 patients

6 784 SAKURAI, ET AL. Jp n. Heart J. November, 1980 Fig. 2. Nomogram showing the relation between maximal balloon diameter and volume of dye within the balloon. The size of No.7 French Swan- Ganz, No.8.5 French Dotter-Lukas, No.8-14 French Fogarty, and No.8-22 French Fogarty catheters are demonstrated. (75%), the defect varied from 15 to 30mm in diameter. Only 2 patients (5%) had a defect smaller than 15mm in diameter and 8 patients (20%) had a defect greater than 30mm in diameter. Five patients from 3 to 5 years in age, 14 patients from 6 to 15 years in age, 7 patients from 16 to 29 years in age, and 14 patients older than 30 years in age had defects ranged from 13 to 18mm (16.4mm on the average), from 14 to 32mm (25.0mm on the average), from 23 to 35mm (27.8mm on the average), and from 20 to 44mm (28.5mm on the average) in diameter, respectively. Patients 11 and 17 with 2 defects and Patient 25 with 4 defects were diagnosed by the balloon catheter test at catheterization and confirmed at operation. Remaining 37 patients of the 40 patients had neither a superior nor inferior defect but a central defect. Thirty patients had a diagnosis of patent foramen ovale. Size of the foramen ovale ranged from 3 to 13mm in diameter (5.2mm on the average). The size of foramen ovale was not related to age. 2) With the temporary balloon occlusion of the defect in 13 out of 40 patients with ASD, pulmonary arterial oxygen saturation and pressure

7 Vol.21 BALLOON CATHETER TEST 785 No.6 Fig. 3. Atrial septal defect is temporarily occluded by a balloon catheter and an oximeter catheter is positioned in the pulmonary artery. Fig. 4. Balloon catheter test in a case of PDA. The filled balloon catheters are present in the descending aorta (A) and the pulmonary artery (B).

8 786 SAKURAI, ET AL. Jpn. Heart J. November, 1980 Table II. Balloon Measurement of PDA in 11 Patients PDA=patent ductus arteriosus; VSD=ventricular septal defect. Fig. 5. Continuous measurement of the pulmonary arterial oxygen saturation in Patient 19. were continuously measured (Fig. 5). In 6 patients with a defect smaller than 24mm in diameter, complete abolition or minimum remainder of the left-to-right shunt was recognized. In 4 patients with a defect greater than 30mm in diameter, it was difficult to occlude the defect because the balloon catheter flowed into the left ventricle. In these cases, a slight decrease in the left-to-right shunt ratio was recognized. In 3 patients with multiple defects, slight decrease in the left-to-right shunt ratio was recognized (Table III). No change in pulmonary arterial pressure was observed because it

9 Vol.21 BALLOON CATHETER TEST 787 No.6 Table III. Results of Temporary Balloon Occlusion of ASD in 13 Patients Qp/Qs=pulmonary to systemic flow ratio; ASD=atrial septal defect. was difficult to occlude a defect by a balloon catheter for a long time. Accordingly, minimum changes in pulmonary to systemic pressure and resistance ratios were recognized. Group 2: PDA All of the 11 patients with PDA diagnosed by cardiac catheterization underwent operation. The difference or the size of the ductus measured at catheterization and at operation was less than 4mm in diameter (Table II). The size at catheterization was as large as or larger than that at operation. The difference was greater in PDA than in ASD because the size of the ductus was not measured with the balloon technique but a measuring rule at operation. The difference may suggest the extensibility of theductus In all of the 9 patients with isolated PDA, no murmur was audible with the temporary balloon occlusion of the ductus In Patients 6 and 8 a holosystolic murmur was heard with occlusion of the ductus. Thus, a diagnosis of PDA associated with ventricular septal defect (VSD) was made in these patients. The ligation of the ductus was performed and the surgical closure of VSD will be carried out in the near future in these patients The temporary balloon occlusion of the ductus may assist in determining whether

10 788 SAKURAI, ET AL. Jp n. Heart J. November, 1980 other cardiac anomalies exist. DISCUSSION Recently, nonoperative closure of the secundum ASD has been carried out in 11 patients.4)-7) Closure of a secundum ASD by nonoperative means requires careful evaluation of the defect.4)-7) The balloon catheter test gives very useful information for nonoperative closure because it provides greater accuracy in determining size, location, and number of the defect than any other methods. A left-to-right shunt ratio more than 30% at the atrial level is considered an adequaton criterion for surgical indication of an isolated ASD. If ASD is associated with pulmonic stenosis, pulmonary hypertension, or other anomalies, however, it is sometimes difficult to determine the indication for surgery solely from the calculation of left-to-right shunt ratio. Atrial septal defects of various size were experimentally created in 30 adult dogs, weighing 13 to 16Kg, through a left thoracotomy according to Yokoyama's9) procedure. The dogs were anesthetized with intravenous pentothal under a stable hemodynamic state with spontaneous respiration and without significant cardiac arrhythmias. Defects ranged in size from 4 to 25mm in diameter. Relation of size of the defect to left-to-right shunt ratio at the atrial level was investigated. Balloon measurement of the defect was carried out at necropsy. Size of the defect was related to left-to-right shunt ratio (Fig. 6). Left-to-right shunt ratio at the atrial level was less than 30% in defects of smaller than 10mm in diameter. This fact suggests that if the balloon-measured diameter is smaller than 10mm in an adult patient without Fig. 6. Relation of the size of ASD to the left-to-right shunt ratio at the atrial level in 30 dogs with experimentally created ASD.

11 Vol.21 BALLOON CATHETER TEST 789 No.6 other anomalies, the patient does not require operation. Our balloon catheter test may assist in determining the criteria for surgical indication. In Patient 15, the first catheterization was carried out at 2 years in age and the second catheterization at 4 years in age. Systolic pulmonary arterial pressure was 40mmHg at 2 years in age and 20mmHg at 4 years in age. Increases from 1.5 to 2.4 in pulmonary to systemic flow ratio and from 34% to 58% in left-to-right shunt ratio were recognized. Size of the defect increased from 11mm in diameter at 2 years in age to 17mm at 4 years in age (Table IV). In the 5 patients from 3 to 5 years in age, size of the defect varied from 13 to 18mm in diameter (16.4mm on the average). In the 21 patients older than 20 years in age, it varied from 20 to 44mm in diameter (28.3mm on the average). These facts may suggest that the size of ASD becomes greater with growth of the body. Edwards10) described that in adults the atrial septal defect varied from 1 to 4cm in diameter, the average defect usually being about 2cm. Keith and associates11) described that in infants and children the defect varied from 2 by 4mm to 15 by 17mm in size. Recently spontaneous closure of ASD has been described.12)-14) Spontaneous closure tends to occur early in life, usually in the first 5 years.11) The balloon catheter test may become useful in corroborating clinical data to document changes in size and possible spontaneous closure. Yalav and associates15) described 12 patients over 60 years in age with secundum atrial septal defects and reported that the pulmonary arterial pressure bore relation to the size of the defect. Six patients (Patients 5, 10, 11, 19, 29, 31) over 50 years in age with a diagnosis of isolated secundum ASD were treated in our department (Table V). Four of the 6 patients underwent successful surgical correction. Pulmonary arterial pressure was 38/ 13mmHg in Patient 11, and 32/18mmHg in Patient 31, though each patient had a large defect. Size of the defect was thus not necessarily related to Table IV. Cardiac Catheterization in Patient 15 PA=pulmonary arterial; Qp/Qs=pulmonary to systemic flow ratio; Pp/Ps=pulmonary to systemic pressure ratio; Rp/Rs=pulmonary to systemic resistance ratio; ASD=atrial septal defect.

12 790 SAKURAI, ET AL. Jpn. Heart J. November, 1980 Table V. Six Patients over 50 Years of Age with ASD PA=pulmonary arterial; Qp/Qs=pulmonary to systemic flow ratio; Pp/Ps=pulmonary to systemic pressure ratio; Rp/Rs=pulmonary to systemic resistance ratio; ASD=atrial septal defect. pulmonary arterial pressure. In the 6 patients over 50 years in age, the defect varied from 20 to 44mm in diameter (27.8mm on the average). In all of the 40 patients with ASD it varied from 13 to 44mm in diameter (25.7mm on the average). The difference in ASD size between different age groups was, however, not significant statistically in our limited number of cases. A patent foramen ovale is common in patients with tetralogy of Fallot.16) Rowe and associates17) studied postmortem specimens and described a 67% incidence of such defect, and Lev and associates18) found a patent foramen ovale in about 50% of necropsy specimens. Levine and associates16) performed hemodynamic assessments in 50 patients following correction of tetralogy of Fallot. They described that in 10 of 50 patients right-to-left shunts at the atrial level were demonstrated and 2 patients with right-to-left shunting sustained systemic arterial emboli, presumably paradoxical, during the late postoperative period. Therefore, they concluded that a patent foramen ovale should be closed at the time of surgical correction of tetralogy of Fallot. Size of a foramen ovale may accurately be measured during cardiac catheterization with the balloon measurement technique and the balloon catheter test may assist in determining criteria for surgical closure of a patent foramen ovale in tetralogy of Fallot. Porstmann2)t described a new method for PDA closure without thoracotomy in Since then, Takamiya19) and Sato20),21) have used this method in more than hundred patients in our country. Angiographies of the ductus and femoral artery are necessary to evaluate the shape and size of the ductus and the width of the femoral artery. Basically, the success of Porstmann's method depends on ratio of the lumen of the femoral artery to

13 Vol.21 BALLOON CATHETER TEST 791 No.6 that of the ductus to be closed. If the lumen of the femoral artery is not wider than the ductus, the plug cannot be safely fixed within the ductus. Sato and associates21) stated that the diameter of the plug should be 20-40% larger than that of the ductus. Comparison of the diameter of the balloon closing the ductus with aortographic size of the ductus may be of importance to know the extensibility of the ductus in Porstmann's method. No significant complications or persistent arrhythmias were caused by the balloon measurement. In ASD, a potential complication is impairment of venous return by an inappropriately placed balloon if there is a delay in deflation. This has not occurred in our experience and should easily be avoided. With large volume of contrast solution, the balloon tends to move toward the mitral valve in ASD or toward the aorta in PDA, however, a movement like this could be prevented or minimized with gentle traction on the catheter. The balloon catheter test at operation in cases of VSD, pulmonic stenosis, mitral valve disease, and aortic valve disease may also provide accurate information regarding size of the defect and width of the valve orifice. REFERENCES 1. Rashkind WJ, Miller WW: Creation of an atrial septal defect without thoracotomy. JAMA 196: 991, Porstmann W, Wierny L, Warnke H: Der Verschluss des Ductuc arteriosus persistens ohne Thorakotomie. Fortschr Roentgenstr 109: 133, Porstmann W, Wierny L, Warnke H, Gerstberger G, Romaniuk PA: Catheter closure of patent ductus arteriosus: 62 cases treated without thoracotomy. Radiol Clin North Am 9: 203, King TD, Mills NL: Nonoperative closure of atrial septal defects. Surgery 75: 383, Mills NL, King TD: Nonoperative closure of left-to-right shunts. J Thorac Cardiovasc Surg 72: 371, King TD, Thompson SL, Steiner C, Mills NL: Secundum atrial septal defect. Nonoperative closure during cardiac catheterization. JAMA 235: 2506, King TD, Thompson SL, Mills NL: Measurement of atrial septal defect during cardiac catheterization. Am J Cardiol 41: 537, Varnauskas E, Werko L: Temporary occlusion of interatrial septal defect in man. Scandinav J Clin & Lab Invest 6: 51, Yokoyama M, Sakakibara S: reation of atrial septal defect through left thoracotomy. J Thorac Cardiovasc Surg 64: 816, Edwards JE: Congenital malformations of the heart and great vessels. A. Malformations of the atrial septal complex. In Pathology of the Heart, III, ed by Gould SE, Charles C Thomas Publisher, Springfield, p. 266, Keith JD, Rowe RD, Vlad P: Atrial septal defect. Heart Disease in Infancy and Childhood, 3rd Ed, Macmillan Publishing Co, New York, p. 380, Hartmann AF Jr, Elliott LP: Spontaneous physiologiclosure of an atrial septal defect after infancy. Am J Cardiol 19: 290, Timmis GC, Cordon S, Reed JO: Spontaneous closure of an atrial septal defect. JAMA

14 792 SAKURAI, ET AL. Jp n. Heart J. November, : 137, Mody MR: Serial hemodynamic observations in secundum atrial septal defect with special reference to spontaneous closure. Am J Cardiol 32: 978, Yalav E, Brown AH, Braimbridge MV: Surgery for atrial septal defect in patients over 60 years of age. J Thorac Cardiovasc Surg 62: 788, Levine FH, Reis RL, Morrow AG: Incidence and significance of patent foramen ovale after correction of tetralogy of Fallot. Ann Thorac Surg 13: 464, Rowe RD, Vlad P, Keith JD: Experiences with 180 cases of tetralogy of Fallot in infants and children. Can Med Assoc J 73: 23, Lev M, Eckner FAO: The pathologic anatomy of tetralogy of Fallot and its variations. Dis Chest 45: 251, Takamiya M: Ductus closure without thoracotomy. Thoracic Surg 26: 749, 1973 (in Japanese) 20. Sato K, Fujino M, Kozuka T, Kawashima Y, Horiguchi Y, Kitamura S, Nakano S, Shimizu Y, Manabe H, Naito Y: Closure of patent ductus arteriosus by Porstmann's method, experiences of 18 cases treated without thoracotomy. Thoracic Surg 26: 812, 1973 (in Japanese) 21. Sato K, Fujino M, Kozuka T, Naito Y, Kitamura S, Nakano S, Ohyama C, Kawashima Y: Transfemoral plug closure of patent ductus arteriosus, experiences in 61 consecutive cases treated without thoracotomy. Circulation 51: 337, 1975

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