Catheterization and Cardiovascular Diagnosis 1:59-70 (1975)

CARDIAC CATHETERIZATION AND SELECTIVE ANGIOGRAPHY IN INFANTS WITH A NEW FLOW-DIRECTED CATHETER David C. Schwartz, M.D., and Samuel Kaplan, M.D. Preliminary experience with a new flow-directed pediatric angiography catheter in 35 infants Indicates that catheterization of all cardiac chambers and both great vessels can be accomplished without risk of perforation or major arrhythmia. Antegrade access to the aorta from the left ventricle via the foramen ovale reduced the need for retrograde arterial Catheterization. The maneuverability of this balloon-tipped cathe ter coupled with the ability to perform safely selective angiography at any Site entered establishes a unique advantage over standard cardiac catheters now in use. The success wlth this catheter in petforming right and left heart studies and the safety in 4s use promise to significantly reduce the risk of mechanical and anglographic accidents during the lntracardlac investigation of critically ill infants with congenital heart disease. Key Words: heart defects, congenital, heart catheterization

The risk associated with cardiac catheterization is greatest among infants critically ill with congenital heart disease ( I , 2, 3). The high complication rate is related to: ( I ) catheter manipulation with the threat of major arrhythmia and cardiac perforation, (2) intram yocardial staining and perforation during selective ventriculography, and (3) metabolic and thermal alterations. While the latter have received considerable attention in recent years with improved methods of maintaining thermal stability, monitoring of blood gases, and vigorous correction of acidosis (4,5 , 6), relatively little has been done to reduce the mechanical hazards which accompany intracardiac investigation of infants. It is the purpose of this communication to report the development and preliminary experience with a new flow-directed pediatric angiography catheter, which has proved to reduce significantly the occurrence of mechanical and angiographic complications while providing full diagnostic capability. From t h W a r t n w n t of Pmdlatrlcs, College of Modlclne, University of Cincinnati and the Chlldnn's Mospltrl, Clnclnnatl, Ohlo. Address requests for reprints to: D-dvid C. Schwartz. M.D.. Division of Cardiology, Children's Hospital, Cincinnati, Ohio 45229. 59

0 1975 Alan R. Liu, IN., 150 Fifth Avenue, NOWYork, N.Y. 10011

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MATERIALS AND METHODS Catheter Specifications

The flow-directed pediatric angiography catheter* is a double-lumen device constructed of soft, 'radiopaque, polyvinyl chloride. The outer diameter is 1.67 mm (SF), the total length is 50 cm, and it is banded at 5 cm intervals. The injection and monitoring lumen terminates in six side holes, three on each side, located 1.0-1.5 cm from the closed catheter tip (Fig. 1). A latex balloon located I mm proximal to the catheter tip communicates via a side hole in the shaft to the second (inflation) lumen. The balloon has a maximum recommended inflation volume of 1 ml. To preclude the occurrence of air embolism due to balloon rupture, carbon dioxide (CO,) was used for balloon inflation. The gas was delivered from a storage sphere fitted with a decompression valve and was passed through a 0.22 micron inline Cathivex** filter. Contrast flow rates were established using full strength Renografin-76 warmecl to 37°C. A maximum flow rate of 8 ml/sec, delivered by a volume-controlled power injector, was readily achieved. There were no instances of catheter rupture at this flow rate; however, at 8 ml/sec catheter whip occurred if maximum (1.0 ml) balloon inflation was not maintained during injection. The frequency response at 10 hertz (Hz) transmitted intravascular pressures with excellent fidelity and in clinical use compared favorably to standard multihole catheters of similar outside diameter (Fig. 2).

Flg. 1. The catheter Ir ohown, wlth the balloon deflated, exposlng the closed tlp.

*Developed in association with and supplied by Edwards Laboratories, Sanra Ana, California. +*Millipore Corporation, Bedford, Massachusetts.

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Catheterization Technique

Catheterization was performed from a sapheno-femoral cutdown in 30 of the 38 procedures. In the remaining eight studies, the catheter was inserted into the femoral vein through a 6F sheath introduced by the percutaneous technique. In the neonate and small infant it was frequently difficult to enter the pulmonary artery since passage of the catheter from the inferior vena cava across the tricuspid valve tended to carry the balloon against the anterior wall of the right ventricle. Catheterization of the pulmonary artery was, however, achieved in most instances by formation of a counterclockwise loop in the right atrium, which brought the balloon into contact with the tricuspid valve at a more favorable angle for the catheter to be propelled into the right ventricular outflow tract (Fig. 3). In the great majority of infants anatomic patency of the foramen ovale permitted transseptal catheterization of the left heart. Access to the left atrium was facilitated in several instances by stenting the catheter with the accompanying stylet preformed into a soft 45-degree curve. This “closed Brockenbrough” technique permitted passage of the catheter through the foramen ovale. Once the catheter was in the left atrium, inflation of the balloon permitted

Fig. 3. Technique of catheter passage from the inferior vena cava to the right ventricular outflow tract and pulmonary artery. Formation of counterclockwise loop In the rlght atrium (A). inflation of balloon then carries the catheter across the tricurpid valve and into the right ventricular outflow tract (B).

immediate access to the left ventricle (Fig. 4). In positioning for selective left ventriculography, the balloon was inflated maximally ( I ml) to insure that the tip

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of the catheter was retracted within the circumference of the balloon. The balloon was then wedged into the left ventricular apex in contact with the endocardium without disturbing cardiac rhythm. With the balloon inflated in the apex of the left ventricle, contrast was delivered through the side holes proximal to the balloon without risk of intramyocardial injection (Fig. 5). The effect of the balloon was to keep the side holes well away from the endocardia1 surface, thus permitting symmetrical delivery of contrast over a wide area of the ventricular cavity. In addition the inflated balloon held the catheter in position reducing catheter whip during power injection of contrast. Biplane selective left ventriculography was performed in 30 infants during pressure injection of 1-1.5 ml/kg of full-strength contrast. Antegrade catheterization of the aorta (pulmonary artery in transposition of the great arteries) from the left ventricle was achieved by first forming a loop in the left atrium (Fig. 6). The catheter loop was then backed into the left ventricle with the balloon. Once the loop cleared the mitral valve, the balloon was inflated, which permitted the catheter to be propelled into the left ventricular outflow tract and out the aorta (Fig. 6b). RESULTS We have used the flow-directed pediatric angiography catheter exclusively to perform 38 studies in 35 infants with a variety of congenital heart diseases (Table 1). Their ages ranged from one day to 3.5 years. Twenty-seven ofthe 38 (71%) were six months or younger and ten of the 38 studies were performed in infants 14 days of age or younger. The pulmonary artery was entered in 29 of the 38 studies. Among the nine failures, four subjects had pulmonary atresia. The aorta was entered antegrade in 22 of the 38 studies, and the left ventricle was entered in all but two cases. Failure to enter the left ventricle occurred in two infants, five and 6.5 months of age, in whom. anatomic closure of the foramen ovale precluded access to the left atrium. In 16 instances all four chambers and both great vessels were catheterized. Selective biplane left ventriculography was performed in 30 of the 36 instances where the left ventricle was entered (Fig. 7). Antegrade aortography was performed in 12 cases. Contrast flow rates ranged from 5 - 8 ml/sec delivered with a volume-controlled power injector. There were no instances of intramyocardial staining or perforation during pressure injection of contrast. Apart from occasional premature contractions occurring principally during manipulation of the catheter in the left ventricle, there were no episodes of catheterinduced tachyarrhythmia or atrio-ventricular (A-V) block. As with the standard Swan-Ganz flow-directed catheter (7, 8), intraventricular manipulation was carried out with the balloon fully inflated ( I ml), which minimized the occurrence of premature ventricular contractions. One fatality occurred which was directly attributable to the procedure. A 2,850 gm infant, with single atrium, single ventricle, and common A-V valve incompetence, developed pulmonary edema and apneic spells at three days of age, which necessitated nasotracheal intubation and assisted ventilation. Cardiac catheterization was carried out on the fourth day of life while the infant was on

Fig. 4. Sequence o f transseptal catheterization of iett atrium and left ventricle. With the catheter lying straight in the right atrium (A), the preformed 0.014 inch wire stylet is introduced into the injectiion lumen and advanced to the tip. The foramen ovale is then probed with the stemted catheter (B).After transseptal passage, the stylet is removed and the balloon inflated. Lett atrial contraction then propels the catheter across the mitral orifice into the left ventricle (C).

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Fig. 5. Catheter position for selecthre left ventriculography. The balloon is maximally inflated and wedged into the left ventricular apex. Contrast is delivered uniformly proximal to the balloon, preventing intramyocardial injection.

Fig. 6. Antegrade catheterization of the aorta from the left ventricle. After crossing the foramen Ovak, the catheter is looped into the left atrium (a) and backed across the mitral orifice. The balloon is then inflated allowing the catheter to be ejected from the left ventricle across the aortic yahre (b).

a n

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TABLE I. Anatomic Diagnoses Obtained from Cardiac Catheterization and Selective Angiography Performed on 35 Infants Malformation d-transposition Ventricular septa1 defect Atrio-ventricular canal Patent ductus arteriosus Atrial sep!al defect (secundum) Dextrocardia, pulmonary atresia Coarctation of arota Common ventricle Truncus type I Truncus type IV Pulmonary atresia - intact septum Dextrocardia, single ventricle Total anomalous pulmonary venous connection Miscellaneous Total

Number of procedures

10 (8 patients) 6 3 ( 2 patients) 3 3 2 2 2 1 1 1 1 1

2

38 (35 Datientsl

the respirator. Shortly following selective ventriculography, profound bradycardia occurred. Despite vigorous resuscitative efforts including transvenous pacing, the infant expired. At autopsy, there was no evidence of cardiac perforation or catheter-induced trauma to the endocardium. DISCUSSION The intracardiac investigation of infants with congenital heart disease has routinely been accomplished with stiff, woven-dacron catheters. The dangers of perforation with this type of catheter are well known to pediatric cardiologists (10, I 1). In the “Cooperative Study on Cardiac Catheterization’’ (I), cardiac perforation occurred in 4.7% of studies performed on infants less than two months of age. This may be an underestimate of the true incidence, since cardiac perforation during catheterization can go undetected. Hemopericardium in infants undergoing palliative surgery shortly after catheterization was performed (10) is occasionally observed. In addition, catheter puncture sites can be identified at necropsy in the hearts of infants who have succumbed following catheterization, where perforation had not been recognized during the study. The successful adaptation of the balloon-tipped, flow-directed catheter to obtain hemodynamic data in patients with congenital heaft disease, as originally proposed by Swan and his associates (7), has virtually eliminated the threat of cardiac perforation while providing access to all cardiac chambers and both great vessels (8, 9). It has been particularly useful in catheterization of the pulmonary artery in infants with transposition of the great arteries (12. 13). The standard Swan-Ganz catheter is, however, an end-ble catheter, which precludes its use for selective ventriculography. Our experience in 35 infants with the flow-directed pediatric angiography catheter indicates that it combines the intracardiac maneuverability of the balloon-tipped catheter with the high flow contrast delivery characteristics of

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Fig. 7. Biplane lett ventriculogram in an infant with total anomalous pulmonary venous return following transseptal catheterizationof the left heart. In the anteroposterior projection (A), the inflated balloon is recognized as a radiolucency near the left ventricular apex. In the lateral projection (B), the mitral orifice is clearly defined during ventricular diastole.

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standard infant angiography catheters. The ease of entering the left ventricle by the transseptal route and the safety of selective left ventriculography make it possible to routinely perform left heart studies in infants with symptomatic congenital heart disease. Antegrade access to the aorta from the left ventricle further obviates the need for retrograde arterial catheterization. The results obtained employing the flow-directed pediatric angiography catheter confirm its value and safety in performing right and left heart studies in the newborn and older infants with congenital heart disease. ACKNOWLEDGMENT The invaluable cooperation of Mr. David Chonette, President, and Mr. Vern Modes, Catheter Product Specialist, Edwards Laboratories, in the development of the flow-directed pediatric angiography catheter is gratefully acknowledged. REFERENCES I . Braunwald, E., Swan, J . H . C. (Eds.) (1968). "Cooperative Study on Cardiac Catheterization.'' Circulation 37 (Suppl. 3):1-113. 2. Varghese, P.J., Celermajer, J., Izukawa, T., Haller, J. A., Jr., and Rowe, R. D. (1969). Cardiac catheterization in the newborn: experience with 100 cases. Pediatrics 44:24-49. 3. Krovetz, L. J., Shanklin, D. R., Schiebler, G . L. (1%8). Serious and fatal complications of catheterization and angiography in infants and children. Amer. Heart J. 76:39. 4. Gersony, W . M . , Hayes, C . J . (1972). Perioperative management of the infant with congenital heart disease. Frog. Cardiovasc. Dis. 15:213-228. 5. Nadas. A. S., Fyler, D. C., Castaneda, A . R. (1973). The critically ill infant with congenital heart disease. Mod. Concep. Cardiovasc. Dis. 4253-58. 6. Rowe, R. D.. Mehrizi, A. (1968). "The Neonate with Congenital Heart Disease." Philadelphia: W. B. Saunders Co. 7. Swan, H . J . C., Ganz, W., Forrester, J., Marcus, H., Diamond, G.,and Chonette, D. (1970). Catheterization of the heart in man with use of a flow-directed balloon-tipped catheter. New Eng. 1. Med. 283:447-452. 8. Stanger, P., Heymann, M. A., Hoffman, J . I. E., and Rudolph, A. M. (1972). Use ofthe Swan-Ganz catheter in cardiac catheterization of infants and children. Amer. Heart J. 83:749-754. 9. Schwartz. D. C:, West, T. D. (1974). Cardiac catheterization in infants and children. Heart and Lung 3:407-414. 10. Lurie, P. K.,Grajo, M. Z. (1%2). Accidental cardiac puncture during right heart catheterization. Pediatrics 29:283-294. I I. Levin. A. R. (1972). The science of cardiac catheterization in the diagnosis of congenital heart disease. Cardiovasc. Clin. 4:236-273. 12. Black, I . F. S. (1972). Floating a catheter into the pulmonary artery in transposition of the great arteries. Amer. Heart J. 84:761-763. 13. Kelly, D. T., Krovetz, L. J., Rowe. R. D. (1971). Double-lumen flotation catheter for use in complex congenital cardiac anomalies. Circulation 44:910-913.

Cardiac catheterization and selective angiography in infants with a new flow-directed catheter.

Preliminary experience with a new flow-directed pediatric angiography catheter in 35 infants indicates that catheterization of all cardiac chambers an...
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