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Transcatheter closure of the patent ductus arteriosus: Comparison between the Rashkind occluder device and the anterograde Gianturco coils technique
Transcatheter closure of the patent ductus arteriosus: Comparison between the Rashkind occluder device and the anterograde Gianturco coils technique O m a r Galal, MD, PhD, a Michael de Moor, M B B C h , FCP, a F a d e l A1-Fadley, MD, a a n d Ziad M. Hijazi, MD b Riyadh, Saudi Arabia, and Boston, Mass. Thirty-five patients (mean age 43.7 months, mean weight 13 kg) underwent anterograde patent ductus arteriosus (PDA) occlusion with Gianturco coils (coil group). These patients were compared with 35 age- and weight-matched patients who underwent closure of their PDA with the Rashkind umbrella device (device group). The mean PDA diameter at its narrowest point was 2.8 mm in the coil group and 2.7 mm in the device group. There was immediate closure angiographically in 20 (57%) of 35 in the coil group compared with 9 (26%) of 35 for the device group. Color flow mapping before discharge revealed complete closure in 30 (86%) of 35 in the coil group compared with 18 (51%) of 35 in the device group (chi square = 9.5455, p < 0.005). Mean fluoroscopy time was 18.5 minutes (median 13.5 minutes) and 14.7 minutes (median 13 minutes) for the coil and device, respectively. Four coils and one device embolized down the pulmonary artery; all were successfully retrieved in the catheterization lab. Coil closure of the small to moderate PDA is safe and effective. It is more effective in achieving immediate closure than the Rashkind device. More clinical trials with the coil technique are warranted to establish the long-term results of this technique. (AM HEART J 1996;131:368-73.)
T h e R a s h k i n d (BARD, G a l w a y , I r e l a n d ) d o u b l e - u m brella device h a s b e e n s h o w n to be effective to occlude t h e p a t e n t d u c t u s a r t e r i o s u s (PDA). 1-3 This device w a s , until recently, u s e d as t h e t h e r a p y of choice to close s m a l l a n d m o d e r a t e P D A s in our institution. H o w e v e r , this device is l i m i t e d to i n f a n t s a n d child r e n l a r g e r t h a n 5 k g b e c a u s e of t h e l a r g e i n t r o d u c e r s h e a t h n e e d e d to deliver t h e device. 4 T h e developm e n t of left p u l m o n a r y a r t e r y stenosis h a s b e e n rec-
ognized as a p o t e n t i a l p r o b l e m . 5 T h e double-umbrella device is f u r t h e r m o r e f r e q u e n t l y associated w i t h a r e s i d u a l shunt. T h e occlusion of t h e v e r y s m a l l P D A u s i n g t h e R a s h k i n d device c a n be difficult. 6"9 Moreover, its u s e is m o r e e x p e n s i v e t h a n t h e surgical a p p r o a c h . 1° O u r goal w a s to c o m p a r e t h e r e s u l t s of o u r s t a n d a r d t h e r a p y ( R a s h k i n d device) w i t h t h e n e w t e c h n i q u e of a n t e r o g r a d e coil occlusion for t h e s m a l l a n d m o d e r a t e P D A in 35 p a t i e n t s w h o u n d e r w e n t this t e c h n i q u e a t our institution. METHODS Patients. Between August 1994 and April 1995, 35 pa-
tients (24 girls and 11 boys) underwent anterograde transcatheter closure of the PDA with single or multiple Gianturco (William Cook Europe A/S, Biaverskov, Denmark) coils (coil group) at the King Faisal Specialist Hospital and Research Center. Mean age was 43.7 -+ 28.8 months (median 36 months, range 9 to 108 months), and mean weight was 13 _+ 4.8 kg (median 12 kg, range 6.2 to 25.4 kg). These patients were compared with a group of 35 patients (27 female, 8 male) who underwent transcatheter closure of their PDA using the Rashkind occluder device (device group). Mean age was 45 _+ 28.7 months (median 36 months, range 11 to 108 months), and mean weight was 13.9 + 4.7 kg (median 13.5 kg, range 6.7 to 23.5 kg) (Table I). The device group was selected from 180 children who underwent the device closure before our institution started using coil occlusion, to match for age and weight. Seven patients in the coil group and four patients in the device group had previously had transcatheter occlusion with the double-umbrella technique, leaving the patients with a residual shunt (Fig. 1). Protocol
From the aDepartment of Cardiovascular Diseases, King Faisal Specialist Hospital and Research Center, Riyadh, and bDepartment of Pediatrics, New England Medical Center, Tufts University School of Medicine, Boston. Received for publication Jan. 3, 1995; accepted June 19, 1995. Reprint requests: Omar M. Galal, MD, PhD, Chief, Section of Pediatric Cardiology, Department of Cardiovascular Diseases, King Faisal Specialist Hospital and Research Center, P.O. Box 3354, MBC-16, Riyadh 11211, Saudi Arabia. Copyright © 1996 by Mosby-Year Book, Inc. 0002-8703/96/$5.00 + 0 4/1/67907
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Coil group. The protocol used to close the PDA with the Gianturco coils has been previously reported, u This protocol was used in the first 10 patients and then modified in the following 25 patients. All patients underwent routine right and left heart catheterization using a 4F sheath in the femoral artery and a 4F sheath in the femoral vein (if more than one coil is needed, one or two additional 4F sheaths were introduced in the other femoral vein). Heparin was not used. A biplane anteroposterior and lateral
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Fig. 1. A, Aortogram in lateral view shows residual s h u n t I year after i m p l a n t a t i o n of 17 m m device. B, Ten m i n u t e s after deployment of three coils. No residual shunt.
Table I. Comparison of different features for both groups
Age (too) Sex (F/M) Weight (kg) Narrowest diameter (ram) Shape of PDA
Reocclusion Qp/Qs MPA pressure (ram Hg) Catheter size Fluoroscopy time (rain) Procedure time (rain) Embolization Total occlusion before discharge
Coil group
Device group
43.7 _+28 (9-108) 24/11 13 _+4.8 (6.2-25.4) 2.8 _+ 1.3 (0.9-6) 25 Conical (71%) 3 Short 2 Tubular 5 Elongated 7 Patients 1.58 -+ 0.7 (1-3.4) 32.6 _+ 12.2 (13-65) 4F/5F 18.5 _+ 13 (4.2-56) 82 -+ 35 (15-162) 4/35
45 _+29 (11-108) 27/8 13.9 _+4.7 (6.7-23.5) 2.7 _+0.9 (0.7-5) 19 Conical (53%) 10 Short 4 Tubular 1 Elongated, 1 complex 4 Patients 2.4 _+2.9 (1-17) 29.5 _+ 10.6 (16-64) 8F/11F 14.7 _+7.8 (7-43) 96 _+33 (54-178) 1/35
30/35 (86%)
18/35 (51%)
descending aortogram was performed to evaluate the size, position a n d a n a t o m y of the PDA. Main p u l m o n a r y artery angiogram in the four-chamber view was performed to assess the left a n d right p u l m o n a r y artery a n a t o m y and to exclude a n y left p u l m o n a r y artery stenosis before coil occlusion. A 4F multipurpose catheter (Microvena, Vadnais, Minn.) was advanced anterogradely to the PDA. If it was difficult to cross the PDA with the catheter alone, a n 0.018-inch Terumo (Tokyo, J a p a n ) guide wire was advanced to the descending aorta through the ductus. The appropriate size coil was advanced into the multipurpose catheter by u s i n g the stiff end of a n 0.038-inch TSF guide wire (Cook, Bloomington, Ind.) u n t i l the coil reached the
Significance
NS -NS NS NS (p = 0.155)~
-NS NS -NS NS NS p < 0.005
inferior v e n a c a v a - r i g h t atrial junction; the coil was then advanced to the tip of the catheter in the descending aorta with the soft end of the wire. The catheter was w i t h d r a w n to the aortic end of the ductus. H a n d injection in the descending aorta opposite the ductus confirmed the location of the PDA. The c0il was pushed out of the catheter to open the first loop in the descending aorta. H a n d injections were repeated to confirm the position of the loops. The catheter was carefully pulled toward the p u l m o n a r y artery while continuously p u s h i n g the coil u n t i l it completely extruded into the ductus and the final loop was opened at the p u l m o n a r y end of the ductus. If the ductus was smaller t h a n 2.5 m m in diameter, a single coil of 2-, 3- or 5-mm di-
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Fig. 2. A, A o r t o g r a m in l a t e r a l view shows conical P D A w i t h n a r r o w e s t d i a m e t e r of 3.5 m m a n d significant left-to-right s h u n t across PDA. B, A o r t o g r a m 10 m i n u t e s after deployment of t h r e e different coils (8 m m × 5 cm, 5 m m x 5 cm, a n d 3 m m × 3 cm). No r e s i d u a l s h u n t across occluded PDA. C, Cineangiography in four-chamber view into p u l m o n a r y a r t e r y after deployment of t h r e e coils shows no sign of proximal left p u l m o n a r y a r t e r y stenosis. a m e t e r d e p e n d i n g on t h e size of the ductus (coil size at l e a s t twice t h e size of t h e n a r r o w e s t d i a m e t e r of the ductus) was used. I f l a r g e r t h a n 2.5 mm, two catheters were advanced a n t e r o g r a d e l y either from each femoral vein or t h r o u g h s e p a r a t e s h e a t h s in one vein. The two coils were released sequentially as described for t h e single-coil technique. I f t h e P D A d i a m e t e r was between 3 a n d 3.5 ram, two coils, one 5 m m x 5 cm a n d a n o t h e r 8 m m x 5 cm, were used. F o r ductus d i a m e t e r g r e a t e r t h a n 3.5 mm, t h r e e coils were used (two 8 m m x 5 cm a n d one 5 m m × 5 cm). These guidelines are not strict rules because the m e a s u r e m e n t s of t h e n a r r o w e s t d i a m e t e r are mostly e s t i m a t e d m e a s u r e ments. Delivery of the coils from t h e venous side enables confirmation of the position of t h e coils by r e p e a t contrast h a n d injections from t h e aortic c a t h e t e r before release. A r e p e a t descending a o r t o g r a m was performed 10 m i n u t e s
after coil deployment to assess the presence of a n y residu a l shunt. In case of verifying a r e s i d u a l shunt, the P D A is recrossed with the end-hole c a t h e t e r and one or more coils are deployed to achieve total closure. R e p e a t m a i n p u l m o n a r y a r t e r y angiogram in the four-chamber view was performed to assess a n y possible left p u l m o n a r y a r t e r y stenosis caused by the coils. R e p e a t oxygen s a t u r a t i o n and p r e s s u r e m e a s u r e m e n t s were performed to evaluate a n y residual s h u n t i n g or obstruction in t h e left p u l m o n a r y art e r y or descending a o r t a caused by t h e coil. A p p r o p r i a t e sedation a n d a n a l g e s i a were used. Kefzol 30 mg/kg was given intravenously during t h e procedure, and t h e s a m e dose was r e p e a t e d 6 hours after. The R a s h k i n d device closure protocol h a s been described previously by several a u t h o r s J -3 Color and Doppler echocardiography. E a c h p a t i e n t
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underwent a complete two-dimensional echocardiographic study and color flow mapping and Doppler interrogation using Hewlett Packard SONOS 1000 within 6 to 24 hours (depending on whether the patient would be discharged on the same day after deployment) looking for residual ductal flow in the main pulmonary artery, left pulmonary artery stenosis, or aortic obstruction following previously described techniques. 12,13 Statistics. The results are expressed as mean _+SD. Comparison between mean values in the two groups was performed by t test. The chi-square test was used to compare the incidence of complete occlusion after PDA closure. A p value of 0.05 was considered significant. RESULTS Coil group. The mean narrowest diameter of the
PDA was 2.8 ± 1.3 m m (range 0.9 to 6 mm). According to the classification adopted by Krichenko et al., 14 72% of the patients had angiographic type A (conic shaped). The mean Qp/Qs ratio was 1.58 ± 0.7 (range I to 3.4, median 1.4), and the mean pulmonary artery pressure was 32.6 _+ 12.2 mm Hg (range 13 to 65 mm Hg). The mean fluoroscopy time was 18.5 ± 13 minutes (range 4.2 to 56 minutes, median 13.5 minutes). There was immediate closure by angiography in 20 patients (Fig. 2), and another 10 patients had complete closure by color flow mapping. Thus a total of 30 (86%) of 35 patients had complete closure within 24 hours before discharge. Follow-up data are not yet available on the five patients discharged with small residual leaks. Device group. The mean PDA narrowest diameter was 2.66 ± 0.9 mm (range 0.7 to 5 ram). According to the classification adopted by Krichenko et al., z4 53% of the patients had angiographic type A (conical shaped). The mean Qp/Qs ratio was 2.4 _+ 2.9 (range i to 17, median 1.6) and the mean pulmonary artery pressure was 29.5 ± 10.6 m m Hg (range 16 to 64 mm Hg). The mean fluoroscopy time was 14.7 ± 7.8 minutes (range 7 to 43 minutes, median 13 minutes). There was immediate closure by angiography in 9 patients and subsequently 9 more patients as documented by color flow mapping (51% rate of complete closure within 24 hours). Four more patients had spontaneous closure of the residual leaks at follow-up between 6 months and 2 years. Thus if those with immediate and late total occlusion are added, the overall total occlusion rate would be 22 (63%) of 35 patients. There was no statistical difference between the two groups regarding PDA diameter, pulmonary artery pressure, Qp/Qs ratio, fluoroscopy time, or procedure time (Table I). There was a statistical difference between the total occlusion rate at discharge in favor of the coil group (chi-square 9.5455,p < 0.005).
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Twenty patients required a single coil, and 15 required multiple coils (two coils in 6 patients, three in 4 patients, four in 3 patients, five in 1 patient, and six in i patient). A total of 67 coils were implanted; eight additional coils were not implanted (four embolized in the left pulmonary artery and were successfully retrieved); four more could not be advanced inside the catheter or were pulled through the PDA and were retrieved while still partially within the catheter (later discarded). Thirty seven devices (26 of the 12-mm device and 11 of the 17-mm device) were used in the device group (two 12-mm devices were wasted). Twenty two patients from the coil group received an outpatient procedure compared with three in the device group. One patient in the coil group versus three patients in the device group were hospitalized for longer than 2 days. Complications. Pull-through of two coils and five devices occurred, which prolonged the procedure. One patient from the coil group and two from the device group required thrombolytic therapy for absent femoral arterial pulse. Four coils and one device erabolized to the left pulmonary artery. All coils and devices were successfully retrieved during the same procedure, and another coil/device was implanted. DISCUSSION
Since the first report on transcatheter closure of patent ductus arteriosus by Porstmann, 15 m a n y devices and methods have been successfully applied to occlude the PDA. Transcatheter occlusion of the PDA with the Rashkind double-umbrella technique is an established mode of therapy with proven safety and efficacy.1"3 There are, however, problems with the Rashkind device. Use of this device is associated with a high incidence of residual shunt. 1-3 The technique is limited to children larger t h a n 5 kg because a large sheath (at least 8F) is used. There is a potential problem ofstenosis of the origin of the left pulmonary artery. 5 The cost oftranscatheter closure of the PDA using the Rashkind occluder device is expensive-more expensive t h a n the standard surgical approach. 1° Cambier et al., 16 Lloyd et al.,17 and Moore et al. is reported a new technique of retrograde closure of the small and moderate PDA with good results by using single Gianturco coils. However, the technique was limited to patients with a PDA measuring up to 3.3 mm with a single coil. Recently Hijazi and Gegge111 described a new technique of anterograde transcatheter closure of the PDA with single or multiple Gianturco coils and 4F catheters. In their report, the largest PDA to be closed was 4.3 mm. Recently a PDA up to 7 m m was successfully closed by this technique
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using seven coils (Hijazi, personal communication). In this study, we compared 35 patients receiving the new technique of anterograde coil occlusion with 35 age- and weight-matched patients who underwent the Rashkind device closure in our institution over the last 5 years. The youngest child in the coil group was 12 months, and the lowest weight was 6.3 kg. Because only a 4F catheter is required for the anterograde coil occlusion (compared with the 8F or l l F sheath for the Rashkind device), smaller infants can now benefit from transcatheter PDA occlusion. This study describes our early experience at the King Faisal Specialist Hospital and Research Center; we have not yet attempted this technique in infants smaller than 5 kg. Another advantage of the small catheters used for anterograde PDA occlusion is the ease with which these catheters cross the tiny PDA, especially the small residual shunt after previous occlusion with a Rashkind device. Although it remains controversial w h e t h e r a tiny residual shunt or even a silent PDA should be closed at all, 19 we have adopted the policy to occlude every residual shunt after deployment of a device because even the small, silent PDA can lead to endarteritis. 2° Deploying a second device is very expensive (approximately $6,000 for two devices, compared with $35 for two coils in addition to the catheters used). Six of the 7 patients in the coil group and 2 of the 4 patients in the device group who underwent occlusion of a residual shunt after a previous Rashkind device had complete occlusion before discharge. Although not statistically significant, there is a trend in favor of the coils. Our results seem to indicate that coil occlusion might be the treatment of choice for the very small PDA and for residual shunts after a previous Rashkind device. There are no studies that evaluate the influence of the different shapes of the PDA on the total occlusion rate, b u t the conical shape should be optimal for both techniques. The coil seems to be more suitable and technically easier for occluding the tiny or small PDA with the elongated or complex form. Further experience is needed to define which morphologic characteristic and size of PDA is more successfully occluded by using either Gianturco coils or the Rashkind device. Patients who underwent coil occlusion of the PDA showed a significantly higher rate of immediate closure than those who received the Rashkind device. This can be explained by the ability to cross the ductus again after placing a coil, the ability to completely eliminate the residual shunt without dislodging the coil, and possibly by some physical characteristics of the coil that are different from the device. As with the
Rashkind device, it is to be expected that on follow-up even more patients will have complete occlusion. Compared with the device group, coils embolized more frequently, which can probably be attributed to our learning curve for a new procedure at our institution. On the other hand they were retrieved relatively easy, and there was no difference in the fluoroscopy or the procedural time. We do not know whether there is a difference between the anterograde technique and the retrograde technique in closing the PDA with coils. From the theoretical point of view, the anterograde approach may leave more loops in the ampulla of the duct than the retrograde approach. Hence the potential development of left pulmonary artery branch stenosis may be less likely when using the anterograde approach. Another advantage of the anterograde approach is that only one arterial catheter is used to confirm the position of the coils during the procedure. Furthermore the anterograde technique allows simultaneous deployment of more than one coil in the large PDA. Although this is a retrospective study, we have attempted to minimize the flaws of such a comparison by using age- and weight-matched patients from our experience (more than 180 patients in five years) of using the Rashkind device. Ideally, a prospective randomized trial comparing the Gianturco coils to the Rashkind umbrella device should be undertaken. Conclusion. Transcatheter closure of the PDA with the Rashkind device or Gianturco coils is safe and effective. To achieve total occlusion of the PDA before discharge, the anterograde technique using coils to occlude the PDA seems to be more effective than the Rashkind device. Coils appear to be particularly useful for the very small PDA and to abolish the residual shunt after previous device occlusion. Coils are less expensive than the Rashkind device. It is more cost-effective to occlude a residual shunt after a previous Rashkind umbrella device by using coils rather than a second device. Follow-up studies are required to assess the long-term results of coil occlusion. W e t h a n k t h e s t a f f o f o u r cardiac c a t h e t e r i z a t i o n laboratory, t h e p r e a d m i s s i o n area, a n d t h e pediatric w a r d s for t h e i r excellent a n d dedicated work.
REFERENCES
1. Ali Khan MA, A1YousefS, Mullins CE, Sawyer W. Experience with 205 procedures of transcatheter closure of ductus arteriosus in 182 patients, with special reference to residual shunts and long-term followup. J Thorac Cardiovasc Surg 1992;104:1721-7. 2. Galal O, Wilson N, Al Fadley F, Duran C, Novice experience with transcatheter closure of the arterial duct in children, adolescents and adults. Cardiol Young 1992;2:285-90.
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3. Tyrian M, Huggon I, Anjos R, et al. Transcatheter occlusion of the persistent arterial duct. Report of the European registry. Lancet 1992; 340:1062-6. 4. Rashkind WJ, Cuaso CC. Transcatheter closure of patent ductus arteriosus: successful use in a 3.5 kg infant. Pediatr Cardiol 1979;1: 3-7. 5. Fadley F, Halees Z, Galal O, Kumar N, Wilson N. Left pulmonary artery stenosis: A serious complication of transcatheter occlusion of the persistent arterial duct. Lancet 1993;341:559-60. 6. Galal O, Abbag F, Fadley F, Redington A. Reopening of an arterial duct after total occlusion with Rashkind's double umbrella device. Cathet Cardiovasc Diagn 1994;33:132-4. 7. Perry SB, Lock JE. Front-loading of double umbrella devices, a new technique for umbrella delivery for closing cardiovascular defects. Am J Cardiol 1992;70:917-20. 8. Nykanen DG, Hayes AM, Benson LN, Freedom RM. Transcatheter patent ductus arteriosus occlusion: application in the small child. J Am Coll Cardiol 1994;23:1666-70. 9. Benson LN, Dyck J, Hecht B, Technique for closure of the small patent ductus arteriosus using the Rashkind occluder. Cathet Cardiovasc Diagn 1988;14:82-4. 10. Gray DT, Fyler DC, Walker AM, Weinstein MC, Chalmer TC. Clinical outcomes and cost-effectiveness of transcatheter versus surgical closure of patent ductus arteriosus. N Engl J Med 1993;329:1517-23. 11. Hijazi ZM, Geggel RL. Results of anterograde transcatheter closure of patent ductus arteriosus using single or multiple Gianturco coils: immediate and short-term results. Am J Cardiol 1994;74:925-9. 12. Musewe NN, Benson LN, Smallhorn JF, Freedom RM. Two-dimen-
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sional echocardiographic and color flow Doppler evaluation of ductal occlusion with the Rashkind prosthesis. Circulation 1989;80:1706-10. Smallhorn JF, Huhta JC, Andersen RH, Macartney FJ. Suprasternal cross-sectional echocardiography in assessment of patent dnctus arteriosus. Br Heart J 1982;48:321-30. Krichenko A, Benson LN, Burrows P, Moes CAF, McLaughlin P, Freedom RM: Angiographic classification of the isolated, persistently patent ductus arteriosus and implications for percutaneous catheter occlusion. Am J Cardiol 1989;67:877-80. Porstmann W, Wierny L, Warnke H, Gerstberger G, Romanieuk PA. Catheter closure of patent ductus arteriosus: 62 cases treated without thoracotomy. Radiol Clin North Am 1971;9:203-18. Cambier PA, Kirby WC, Wortham DC, Moore JW. Percutaneous closure of the small (2.5 ram) patent ductus arteriosus using coil embolization. Am J Cardiol 1992;69:815-6. Lloyd TR, Fedderly R, Mendelsohn AM, Sandhu SK, Beekman III RH. Transcatheter occlusion of patent ductus arteriosus with Gianturco coils. Circulation 1993;88(1):1412-20. Moore JW, George L, Kirkpatrick SE, Mathewson JW, Splcer RL, Uzark K, Rothman A, Cambier PA, Slack MC, Kirby WC. Percutaneous closure of the small patent ductus arteriosus using occluding spring coils. J Am Coll Cardiol 1994;23:759-65. Latson LA. Residual shunts after transcatheter closure of patent ductus arteriosus: a major concern or benign "techno-malady"? Circulation 1991;84:2591-3. Balzer DT, Spray TL, McMullin D, Cottingham W, Canter CE. Endarteritis associated with a clinically silent patent ductus arteriosus. AM HEARTJ 1993;125:1192-3.
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T h e R a s h k i n d (BARD, G a l w a y , I r e l a n d ) d o u b l e - u m brella device h a s b e e n s h o w n to be effective to occlude t h e p a t e n t d u c t u s a r t e r i o s u s (PDA). 1-3 This device w a s , until recently, u s e d as t h e t h e r a p y of choice to close s m a l l a n d m o d e r a t e P D A s in our institution. H o w e v e r , this device is l i m i t e d to i n f a n t s a n d child r e n l a r g e r t h a n 5 k g b e c a u s e of t h e l a r g e i n t r o d u c e r s h e a t h n e e d e d to deliver t h e device. 4 T h e developm e n t of left p u l m o n a r y a r t e r y stenosis h a s b e e n rec-
ognized as a p o t e n t i a l p r o b l e m . 5 T h e double-umbrella device is f u r t h e r m o r e f r e q u e n t l y associated w i t h a r e s i d u a l shunt. T h e occlusion of t h e v e r y s m a l l P D A u s i n g t h e R a s h k i n d device c a n be difficult. 6"9 Moreover, its u s e is m o r e e x p e n s i v e t h a n t h e surgical a p p r o a c h . 1° O u r goal w a s to c o m p a r e t h e r e s u l t s of o u r s t a n d a r d t h e r a p y ( R a s h k i n d device) w i t h t h e n e w t e c h n i q u e of a n t e r o g r a d e coil occlusion for t h e s m a l l a n d m o d e r a t e P D A in 35 p a t i e n t s w h o u n d e r w e n t this t e c h n i q u e a t our institution. METHODS Patients. Between August 1994 and April 1995, 35 pa-
tients (24 girls and 11 boys) underwent anterograde transcatheter closure of the PDA with single or multiple Gianturco (William Cook Europe A/S, Biaverskov, Denmark) coils (coil group) at the King Faisal Specialist Hospital and Research Center. Mean age was 43.7 -+ 28.8 months (median 36 months, range 9 to 108 months), and mean weight was 13 _+ 4.8 kg (median 12 kg, range 6.2 to 25.4 kg). These patients were compared with a group of 35 patients (27 female, 8 male) who underwent transcatheter closure of their PDA using the Rashkind occluder device (device group). Mean age was 45 _+ 28.7 months (median 36 months, range 11 to 108 months), and mean weight was 13.9 + 4.7 kg (median 13.5 kg, range 6.7 to 23.5 kg) (Table I). The device group was selected from 180 children who underwent the device closure before our institution started using coil occlusion, to match for age and weight. Seven patients in the coil group and four patients in the device group had previously had transcatheter occlusion with the double-umbrella technique, leaving the patients with a residual shunt (Fig. 1). Protocol
From the aDepartment of Cardiovascular Diseases, King Faisal Specialist Hospital and Research Center, Riyadh, and bDepartment of Pediatrics, New England Medical Center, Tufts University School of Medicine, Boston. Received for publication Jan. 3, 1995; accepted June 19, 1995. Reprint requests: Omar M. Galal, MD, PhD, Chief, Section of Pediatric Cardiology, Department of Cardiovascular Diseases, King Faisal Specialist Hospital and Research Center, P.O. Box 3354, MBC-16, Riyadh 11211, Saudi Arabia. Copyright © 1996 by Mosby-Year Book, Inc. 0002-8703/96/$5.00 + 0 4/1/67907
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Coil group. The protocol used to close the PDA with the Gianturco coils has been previously reported, u This protocol was used in the first 10 patients and then modified in the following 25 patients. All patients underwent routine right and left heart catheterization using a 4F sheath in the femoral artery and a 4F sheath in the femoral vein (if more than one coil is needed, one or two additional 4F sheaths were introduced in the other femoral vein). Heparin was not used. A biplane anteroposterior and lateral
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Fig. 1. A, Aortogram in lateral view shows residual s h u n t I year after i m p l a n t a t i o n of 17 m m device. B, Ten m i n u t e s after deployment of three coils. No residual shunt.
Table I. Comparison of different features for both groups
Age (too) Sex (F/M) Weight (kg) Narrowest diameter (ram) Shape of PDA
Reocclusion Qp/Qs MPA pressure (ram Hg) Catheter size Fluoroscopy time (rain) Procedure time (rain) Embolization Total occlusion before discharge
Coil group
Device group
43.7 _+28 (9-108) 24/11 13 _+4.8 (6.2-25.4) 2.8 _+ 1.3 (0.9-6) 25 Conical (71%) 3 Short 2 Tubular 5 Elongated 7 Patients 1.58 -+ 0.7 (1-3.4) 32.6 _+ 12.2 (13-65) 4F/5F 18.5 _+ 13 (4.2-56) 82 -+ 35 (15-162) 4/35
45 _+29 (11-108) 27/8 13.9 _+4.7 (6.7-23.5) 2.7 _+0.9 (0.7-5) 19 Conical (53%) 10 Short 4 Tubular 1 Elongated, 1 complex 4 Patients 2.4 _+2.9 (1-17) 29.5 _+ 10.6 (16-64) 8F/11F 14.7 _+7.8 (7-43) 96 _+33 (54-178) 1/35
30/35 (86%)
18/35 (51%)
descending aortogram was performed to evaluate the size, position a n d a n a t o m y of the PDA. Main p u l m o n a r y artery angiogram in the four-chamber view was performed to assess the left a n d right p u l m o n a r y artery a n a t o m y and to exclude a n y left p u l m o n a r y artery stenosis before coil occlusion. A 4F multipurpose catheter (Microvena, Vadnais, Minn.) was advanced anterogradely to the PDA. If it was difficult to cross the PDA with the catheter alone, a n 0.018-inch Terumo (Tokyo, J a p a n ) guide wire was advanced to the descending aorta through the ductus. The appropriate size coil was advanced into the multipurpose catheter by u s i n g the stiff end of a n 0.038-inch TSF guide wire (Cook, Bloomington, Ind.) u n t i l the coil reached the
Significance
NS -NS NS NS (p = 0.155)~
-NS NS -NS NS NS p < 0.005
inferior v e n a c a v a - r i g h t atrial junction; the coil was then advanced to the tip of the catheter in the descending aorta with the soft end of the wire. The catheter was w i t h d r a w n to the aortic end of the ductus. H a n d injection in the descending aorta opposite the ductus confirmed the location of the PDA. The c0il was pushed out of the catheter to open the first loop in the descending aorta. H a n d injections were repeated to confirm the position of the loops. The catheter was carefully pulled toward the p u l m o n a r y artery while continuously p u s h i n g the coil u n t i l it completely extruded into the ductus and the final loop was opened at the p u l m o n a r y end of the ductus. If the ductus was smaller t h a n 2.5 m m in diameter, a single coil of 2-, 3- or 5-mm di-
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Fig. 2. A, A o r t o g r a m in l a t e r a l view shows conical P D A w i t h n a r r o w e s t d i a m e t e r of 3.5 m m a n d significant left-to-right s h u n t across PDA. B, A o r t o g r a m 10 m i n u t e s after deployment of t h r e e different coils (8 m m × 5 cm, 5 m m x 5 cm, a n d 3 m m × 3 cm). No r e s i d u a l s h u n t across occluded PDA. C, Cineangiography in four-chamber view into p u l m o n a r y a r t e r y after deployment of t h r e e coils shows no sign of proximal left p u l m o n a r y a r t e r y stenosis. a m e t e r d e p e n d i n g on t h e size of the ductus (coil size at l e a s t twice t h e size of t h e n a r r o w e s t d i a m e t e r of the ductus) was used. I f l a r g e r t h a n 2.5 mm, two catheters were advanced a n t e r o g r a d e l y either from each femoral vein or t h r o u g h s e p a r a t e s h e a t h s in one vein. The two coils were released sequentially as described for t h e single-coil technique. I f t h e P D A d i a m e t e r was between 3 a n d 3.5 ram, two coils, one 5 m m x 5 cm a n d a n o t h e r 8 m m x 5 cm, were used. F o r ductus d i a m e t e r g r e a t e r t h a n 3.5 mm, t h r e e coils were used (two 8 m m x 5 cm a n d one 5 m m × 5 cm). These guidelines are not strict rules because the m e a s u r e m e n t s of t h e n a r r o w e s t d i a m e t e r are mostly e s t i m a t e d m e a s u r e ments. Delivery of the coils from t h e venous side enables confirmation of the position of t h e coils by r e p e a t contrast h a n d injections from t h e aortic c a t h e t e r before release. A r e p e a t descending a o r t o g r a m was performed 10 m i n u t e s
after coil deployment to assess the presence of a n y residu a l shunt. In case of verifying a r e s i d u a l shunt, the P D A is recrossed with the end-hole c a t h e t e r and one or more coils are deployed to achieve total closure. R e p e a t m a i n p u l m o n a r y a r t e r y angiogram in the four-chamber view was performed to assess a n y possible left p u l m o n a r y a r t e r y stenosis caused by the coils. R e p e a t oxygen s a t u r a t i o n and p r e s s u r e m e a s u r e m e n t s were performed to evaluate a n y residual s h u n t i n g or obstruction in t h e left p u l m o n a r y art e r y or descending a o r t a caused by t h e coil. A p p r o p r i a t e sedation a n d a n a l g e s i a were used. Kefzol 30 mg/kg was given intravenously during t h e procedure, and t h e s a m e dose was r e p e a t e d 6 hours after. The R a s h k i n d device closure protocol h a s been described previously by several a u t h o r s J -3 Color and Doppler echocardiography. E a c h p a t i e n t
Volume 131, Number 1 American Heart Journal
underwent a complete two-dimensional echocardiographic study and color flow mapping and Doppler interrogation using Hewlett Packard SONOS 1000 within 6 to 24 hours (depending on whether the patient would be discharged on the same day after deployment) looking for residual ductal flow in the main pulmonary artery, left pulmonary artery stenosis, or aortic obstruction following previously described techniques. 12,13 Statistics. The results are expressed as mean _+SD. Comparison between mean values in the two groups was performed by t test. The chi-square test was used to compare the incidence of complete occlusion after PDA closure. A p value of 0.05 was considered significant. RESULTS Coil group. The mean narrowest diameter of the
PDA was 2.8 ± 1.3 m m (range 0.9 to 6 mm). According to the classification adopted by Krichenko et al., 14 72% of the patients had angiographic type A (conic shaped). The mean Qp/Qs ratio was 1.58 ± 0.7 (range I to 3.4, median 1.4), and the mean pulmonary artery pressure was 32.6 _+ 12.2 mm Hg (range 13 to 65 mm Hg). The mean fluoroscopy time was 18.5 ± 13 minutes (range 4.2 to 56 minutes, median 13.5 minutes). There was immediate closure by angiography in 20 patients (Fig. 2), and another 10 patients had complete closure by color flow mapping. Thus a total of 30 (86%) of 35 patients had complete closure within 24 hours before discharge. Follow-up data are not yet available on the five patients discharged with small residual leaks. Device group. The mean PDA narrowest diameter was 2.66 ± 0.9 mm (range 0.7 to 5 ram). According to the classification adopted by Krichenko et al., z4 53% of the patients had angiographic type A (conical shaped). The mean Qp/Qs ratio was 2.4 _+ 2.9 (range i to 17, median 1.6) and the mean pulmonary artery pressure was 29.5 ± 10.6 m m Hg (range 16 to 64 mm Hg). The mean fluoroscopy time was 14.7 ± 7.8 minutes (range 7 to 43 minutes, median 13 minutes). There was immediate closure by angiography in 9 patients and subsequently 9 more patients as documented by color flow mapping (51% rate of complete closure within 24 hours). Four more patients had spontaneous closure of the residual leaks at follow-up between 6 months and 2 years. Thus if those with immediate and late total occlusion are added, the overall total occlusion rate would be 22 (63%) of 35 patients. There was no statistical difference between the two groups regarding PDA diameter, pulmonary artery pressure, Qp/Qs ratio, fluoroscopy time, or procedure time (Table I). There was a statistical difference between the total occlusion rate at discharge in favor of the coil group (chi-square 9.5455,p < 0.005).
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Twenty patients required a single coil, and 15 required multiple coils (two coils in 6 patients, three in 4 patients, four in 3 patients, five in 1 patient, and six in i patient). A total of 67 coils were implanted; eight additional coils were not implanted (four embolized in the left pulmonary artery and were successfully retrieved); four more could not be advanced inside the catheter or were pulled through the PDA and were retrieved while still partially within the catheter (later discarded). Thirty seven devices (26 of the 12-mm device and 11 of the 17-mm device) were used in the device group (two 12-mm devices were wasted). Twenty two patients from the coil group received an outpatient procedure compared with three in the device group. One patient in the coil group versus three patients in the device group were hospitalized for longer than 2 days. Complications. Pull-through of two coils and five devices occurred, which prolonged the procedure. One patient from the coil group and two from the device group required thrombolytic therapy for absent femoral arterial pulse. Four coils and one device erabolized to the left pulmonary artery. All coils and devices were successfully retrieved during the same procedure, and another coil/device was implanted. DISCUSSION
Since the first report on transcatheter closure of patent ductus arteriosus by Porstmann, 15 m a n y devices and methods have been successfully applied to occlude the PDA. Transcatheter occlusion of the PDA with the Rashkind double-umbrella technique is an established mode of therapy with proven safety and efficacy.1"3 There are, however, problems with the Rashkind device. Use of this device is associated with a high incidence of residual shunt. 1-3 The technique is limited to children larger t h a n 5 kg because a large sheath (at least 8F) is used. There is a potential problem ofstenosis of the origin of the left pulmonary artery. 5 The cost oftranscatheter closure of the PDA using the Rashkind occluder device is expensive-more expensive t h a n the standard surgical approach. 1° Cambier et al., 16 Lloyd et al.,17 and Moore et al. is reported a new technique of retrograde closure of the small and moderate PDA with good results by using single Gianturco coils. However, the technique was limited to patients with a PDA measuring up to 3.3 mm with a single coil. Recently Hijazi and Gegge111 described a new technique of anterograde transcatheter closure of the PDA with single or multiple Gianturco coils and 4F catheters. In their report, the largest PDA to be closed was 4.3 mm. Recently a PDA up to 7 m m was successfully closed by this technique
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using seven coils (Hijazi, personal communication). In this study, we compared 35 patients receiving the new technique of anterograde coil occlusion with 35 age- and weight-matched patients who underwent the Rashkind device closure in our institution over the last 5 years. The youngest child in the coil group was 12 months, and the lowest weight was 6.3 kg. Because only a 4F catheter is required for the anterograde coil occlusion (compared with the 8F or l l F sheath for the Rashkind device), smaller infants can now benefit from transcatheter PDA occlusion. This study describes our early experience at the King Faisal Specialist Hospital and Research Center; we have not yet attempted this technique in infants smaller than 5 kg. Another advantage of the small catheters used for anterograde PDA occlusion is the ease with which these catheters cross the tiny PDA, especially the small residual shunt after previous occlusion with a Rashkind device. Although it remains controversial w h e t h e r a tiny residual shunt or even a silent PDA should be closed at all, 19 we have adopted the policy to occlude every residual shunt after deployment of a device because even the small, silent PDA can lead to endarteritis. 2° Deploying a second device is very expensive (approximately $6,000 for two devices, compared with $35 for two coils in addition to the catheters used). Six of the 7 patients in the coil group and 2 of the 4 patients in the device group who underwent occlusion of a residual shunt after a previous Rashkind device had complete occlusion before discharge. Although not statistically significant, there is a trend in favor of the coils. Our results seem to indicate that coil occlusion might be the treatment of choice for the very small PDA and for residual shunts after a previous Rashkind device. There are no studies that evaluate the influence of the different shapes of the PDA on the total occlusion rate, b u t the conical shape should be optimal for both techniques. The coil seems to be more suitable and technically easier for occluding the tiny or small PDA with the elongated or complex form. Further experience is needed to define which morphologic characteristic and size of PDA is more successfully occluded by using either Gianturco coils or the Rashkind device. Patients who underwent coil occlusion of the PDA showed a significantly higher rate of immediate closure than those who received the Rashkind device. This can be explained by the ability to cross the ductus again after placing a coil, the ability to completely eliminate the residual shunt without dislodging the coil, and possibly by some physical characteristics of the coil that are different from the device. As with the
Rashkind device, it is to be expected that on follow-up even more patients will have complete occlusion. Compared with the device group, coils embolized more frequently, which can probably be attributed to our learning curve for a new procedure at our institution. On the other hand they were retrieved relatively easy, and there was no difference in the fluoroscopy or the procedural time. We do not know whether there is a difference between the anterograde technique and the retrograde technique in closing the PDA with coils. From the theoretical point of view, the anterograde approach may leave more loops in the ampulla of the duct than the retrograde approach. Hence the potential development of left pulmonary artery branch stenosis may be less likely when using the anterograde approach. Another advantage of the anterograde approach is that only one arterial catheter is used to confirm the position of the coils during the procedure. Furthermore the anterograde technique allows simultaneous deployment of more than one coil in the large PDA. Although this is a retrospective study, we have attempted to minimize the flaws of such a comparison by using age- and weight-matched patients from our experience (more than 180 patients in five years) of using the Rashkind device. Ideally, a prospective randomized trial comparing the Gianturco coils to the Rashkind umbrella device should be undertaken. Conclusion. Transcatheter closure of the PDA with the Rashkind device or Gianturco coils is safe and effective. To achieve total occlusion of the PDA before discharge, the anterograde technique using coils to occlude the PDA seems to be more effective than the Rashkind device. Coils appear to be particularly useful for the very small PDA and to abolish the residual shunt after previous device occlusion. Coils are less expensive than the Rashkind device. It is more cost-effective to occlude a residual shunt after a previous Rashkind umbrella device by using coils rather than a second device. Follow-up studies are required to assess the long-term results of coil occlusion. W e t h a n k t h e s t a f f o f o u r cardiac c a t h e t e r i z a t i o n laboratory, t h e p r e a d m i s s i o n area, a n d t h e pediatric w a r d s for t h e i r excellent a n d dedicated work.
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3. Tyrian M, Huggon I, Anjos R, et al. Transcatheter occlusion of the persistent arterial duct. Report of the European registry. Lancet 1992; 340:1062-6. 4. Rashkind WJ, Cuaso CC. Transcatheter closure of patent ductus arteriosus: successful use in a 3.5 kg infant. Pediatr Cardiol 1979;1: 3-7. 5. Fadley F, Halees Z, Galal O, Kumar N, Wilson N. Left pulmonary artery stenosis: A serious complication of transcatheter occlusion of the persistent arterial duct. Lancet 1993;341:559-60. 6. Galal O, Abbag F, Fadley F, Redington A. Reopening of an arterial duct after total occlusion with Rashkind's double umbrella device. Cathet Cardiovasc Diagn 1994;33:132-4. 7. Perry SB, Lock JE. Front-loading of double umbrella devices, a new technique for umbrella delivery for closing cardiovascular defects. Am J Cardiol 1992;70:917-20. 8. Nykanen DG, Hayes AM, Benson LN, Freedom RM. Transcatheter patent ductus arteriosus occlusion: application in the small child. J Am Coll Cardiol 1994;23:1666-70. 9. Benson LN, Dyck J, Hecht B, Technique for closure of the small patent ductus arteriosus using the Rashkind occluder. Cathet Cardiovasc Diagn 1988;14:82-4. 10. Gray DT, Fyler DC, Walker AM, Weinstein MC, Chalmer TC. Clinical outcomes and cost-effectiveness of transcatheter versus surgical closure of patent ductus arteriosus. N Engl J Med 1993;329:1517-23. 11. Hijazi ZM, Geggel RL. Results of anterograde transcatheter closure of patent ductus arteriosus using single or multiple Gianturco coils: immediate and short-term results. Am J Cardiol 1994;74:925-9. 12. Musewe NN, Benson LN, Smallhorn JF, Freedom RM. Two-dimen-
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