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Long-term outcome comparison between rashkind umbrella and gianturco coils occlusion in native patent ductus arteriosus
Long-term Outcome Comparison Between Rashkind Umbrella And Gianturco Coils Occlusion In Native Patent Ductus Arteriosus Hasri Samion,
Mazeni Alwi, MRCP, Haifa A. Latif, MD, Geetha Kandavel, Kang M. Lim, MRCP, Robaayah Zambahari, FRCP, FACC MD,
MRCP,
Institut Jantung Negara (National Heart Institute), Kuala Lumpur, Malaysia Background: The Rashkind Umbrella device has proven effective in closing small to moderate
size patent ductus arteriosus. A comparable early occlusion rate was also seen in PDA occlusion using Gianturco coils. This study addresses the long-term outcome of both techniques in a single centre. Methods: Review was undertaken of 522 patients with PDA who underwent transcatheter occlusion before January 1997; 244 patients (mean: age 8.Ok6.7 years, weight 21.8k12.9 kg, PDA size 3.2kl.O mm) were intended to receive the Rashkind Umbrella device and the remaining 278 patients (mean: age 6.4k5.6 years, weight 18.6f11.2 kg, PDA size 2.5fl.O mm) would receive Gianturco coils. Deployment failure occurred in 8 patients (3%) and 6 (2%) during the initial learning curve of the Rashkind Umbrella and Gianturco coil, respectively. In the Rashkind Umbrella group, haemolysis occurred in 6, device embolisation in 3, and 1 patient died from anaesthetic sequelae. Peripheral pulmonary embolisation of coils occurred in 7 patients and all were successfully retrieved. Results: Results were analysed from 228 and 258 patients who had successful Rashkind Umbrella device and Gianturco coil deployment respectively. All had completed at least 1 year follow-up. They were evaluated clinically for residual ductal murmur and echocardiographically for a residual ductal shunt and presence of pulmonary artery or aortic obstruction. The Rashkind Umbrella group had significantly higher residual shunt compared to the Gianturco coil group at various stages of follow-up (pcO.O5), 40% v 22% at 24 hours, 29% v 7% at 3 months, 25% v 4% at 6 months and 22% v 3% at 1 year. In 57 patients, a reocclusion procedure during the study period was undertaken to effect immediate complete occlusion. Mild left pulmonary artery stenosis (velocity>2 m/s) was noted in 6 patients who had multiple coils and one who had a 17 mm Rashkind Umbrella device. Conclusions: Transcatheter occlusion of PDA using the Gianturco coil is safer and more effective than the Rashkind Umbrella device. It has become the first choice for treating small to moderate size native PDA at our institution. (Asia Pacific Heart J 1999; 8(2):102-105) Introduction
procedure.s+lO This study analyses the comparative clinical outcome of the Rashkind Umbrella device and the Gianturco coil involving 522 patients with native PDA who underwent a single initial occlusion procedure at one institution.
Transcatheter occlusion of small to moderately large native PDA has been shown to be safe and effective with conventional surgical ligation reserved for a large PDA or symptomatic infants. Amongst these purpose-designed devices, the Rashkind Umbrella device was the most extensively used and investigated in many centres.Q7s~4 This technique involves the delivery of occluder devices via a large delivery sheath (8F or 11F) that limits its use in small children. It also has a relatively high incidence of residual shunt (20%-38%) at 1 year.4,5
Methods Between June 1992 and December 1996,522 patients with native PDA underwent unrandomised transcatheter occlusion at the National Heart Institute, Kuala Lumpur, and were retrospectively reviewed. They had been followed-up for at least 1 year. All patients, of whom the majority were asymptomatic, had typical clinical signs of PDA which was confiied by echocardiography. At our centre, the Rashkind Umbrella device was introduced in June 1992 for small to moderate native PDA, and the Gianturco coil in April 1994, initially for residual shunt following either Rashkind Umbrella device occlusion or
On the other hand, over the past 4-5 years, a nonpurpose-designed conventional Gianturco coil has been shown to be a good alternative ‘device’.6S7Ss79 It is easily introduced via a small (4F) catheter making it feasible and safe in smaller children. The early occlusion rate is comparable and, more importantly, it is a less expensive
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Table 1. Clinical data.
patients. Of these, 215 (83%) patients received 2 or more coils, with a mean of 2.7 coils per patient. There was no statistical difference in terms of the clinical data between the two groups (Table 1). Although the mean PDA diameter in the coil group appeared smaller (2.5kl.O mm) compared to the Rashkind Umbrella group, they were not statistically significant (p>O.O5). The median follow-up was 46 months (range, 30 to 74) in the Rashkind Umbrella group compared to 30 months (range, 20 to 44) in the Gianturco coil group.
RashlcindUmbrella device Gianturco coil n=244 n=258 Age (years) Weight (kg) PDA size(mm) Screening(min) Device Follow-up (median)
8.0f6.7 21.8f12.9 3.2kl.O 11Sf10.0 146 (60%) size 17 mm 98 size 12 mm
6.4+5.6 18.6f11.2 2.5fl .o 13.6+11.0 215 (83%) > 2 coils 2.7fl.2 per patient
46 (30-74) months
3 1 (20-44) months
Exclusion from clinical outcome analysis Thirty-six patients (7%) were excluded from analysis for various reasons. Deployment failure occurred in 8 patients in the Rashkind Umbrella group, and they subsequently underwent surgical ligation. In the coil group, 6 patients underwent occlusion with the Rashkind Umbrella device following unsuccessful occlusion prior to the use of multiple catheters technique.
Data are presented as mean&SD. There were no statistical differences in age, body weight, PDA size and screening time between the 2 groups. surgical ligation, but these patients were not included in the study. The Rashkind device was no longer available by June 1996. Methods for Rashkind Umbrella device implantation were well established,l,*s” whilst the technique of Gianturco coil occlusion using antegrade multiple catheters in our laboratory has been previously described.rr The narrowest diameter of the ducts was measured following aortic angiography. As a guideline, 3.5 mm duct diameter was the cut-off point in selecting either the 12 mm or 17 mm Rashkind Umbrella device. In the early learning phase, only small PDAs were occluded using single catheter technique and smaller coils (5 mm). The multiple catheters technique was subsequently used for up to 5.0 mm PDA. The following guideline for Gianturco coil occlusion was used: 1 coil for ducts less than 1.5 mm, 2 coils for 1.6-2.5 mm, 3 coils for 2.6-3.5 mm, 4 coils for 3.6-4.0 mm, and 5 or more coils for ducts larger than 4.0 mm. No attempts were made to occlude ducts larger than 5.0 mm in diameter.
Rashkind Umbrella device embolisation to peripheral pulmonary artery occurred in 3. All were successfully retrieved prior to surgical ligation in 2, and reocclusion in 1. A total of 7 early reocclusion procedures (within 7 days) were performed, for haemolysis in 4 and geographical reasons in 3. Two patients who developed severe haemolysis underwent surgical removal of an umbrella device and ligation of the PDA. There was 1 anaesthetic death unrelated to the Rashkind Umbrella occlusion procedure. Ten patients were excluded for incomplete follow-up. Of these, 6 had shown complete occlusion whilst 4 had systolic residual shunt murmur and continuous shunt on colour flow mapping at the 24-hour assessment. Occlusion rate The clinical outcome results were analysed from 486 patients (228 Rashkind Umbrella group, 258 Gianturco coil group) who had a successful single occlusion procedure. The Rashkind Umbrella group had significantly higher residual shunt compared to the Gianturco coil group at various stages of follow-up (Fig. 1). At 24 hours, residual shunts were present in 22% of the Gianturco coil group, compared to 40% in the Rashkind Umbrella group. The maximum occlusion rate of more than 95% was achieved 6 months after coil occlusion compared to the Rashkind Umbrella group which had a more gradual increase in occlusion rate. During the study period, there were 57 reocclusion procedures in 53 patients (12%) with immediate complete occlusion. Ten (18%) of these were performed at between 6 months and 1 year of follow-up for significant residual shunt with continuous murmur. The remainder, who had a systolic murmur and a continuous shunt signal on colour flow mapping or CW doppler, were performed after 1 year of follow-up. Seven of these 10 patients were from the Rashkind Umbrella group and required an additional Rashkind Umbrella device. The
No patient was excluded on the basis of ductus morphology. 12 The procedure was performed under general anaesthesia in smaller children. Heparinisation (50 U/kg) after cannulation and intravenous cefuroxime (30 mg/kg) prior to device deployment were routinely given. Clinical examination, chest X-ray examination and echocardiography were done 24 hours before discharge and subsequently at 3 months, 6 months and 1 year, specifically to look for residual shunt and presence of left pulmonary artery or aortic obstruction.‘3 An option for reocclusion was offered if a clinical residual shunt (continuous or systolic murmur) and confirmed by colour flow mapping which persisted after 6 months of followup. Reocclusion was not offered for silent residual shunt detected by colour flow mapping. Results Clinical data In the Rashkind Umbrella group, 146 17-mm 12-mm devices were deployed in 244 children. Gianturco coil group, a total of 688 coils with diameters of 5 mm and 8 mm were deployed
Alwi, Latif, Kandavel, Lim, Zambahari Rashkind Umbrella and Gianturco coils
and 98 In the helical in 258
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Alwi, Latif, Kandavel, Lim, Zambahari Rashkind Umbrella and Gianturco coils
Table 2. Complications.
Rashkind device n=244
Haemolysis* Embolisation** Anaesthetic death WA stenosis***
Gianturco coil n=278
Total n=522
6 (2%) 3 (1%)
0 (0) 7 (3%)
1 (0.5%) 3 (1%)
0 (0)
10 (2%) 1 (0.2%)
5 (2%)
8 (2%)
25
6 (1.2%)
* Four of the 6 patients who had haemolysis underwent early second device occlusion, and the remaining 2 underwent surgicalremoval and ligation. ** All embolised device/coils in 10 patients were easily retrieved and 2 underwent surgical ligation whilst 8 were successfullyreoccluded with device/coils. *** Peak flow velocity>2.0 m/set.
Follow
up duration
Fig. 1. Incidence of residual shunt, assuming no reocclusion
procedure in 10 patients and the residual shunt persisted at lyear follow-up.
remaining 3 patients were from the coil group, and defects were closed using coils. Without a reocclusion procedure, the prevalences of residual shunts at 1 year were 3% and 22%, respectively, in favor of the Gianturco coil over the Rashkind device.
Rashkind Umbrella device.@ The immediate and 24 hours occlusion rate was significantly higher in larger PDAs occluded using coils in a randomised age-matched control study.10
Complications The overall complication rate was less than 5% (Table 2). Six patients developed haemolysis. These patients were from the Rashkind Umbrella group, requiring a second device or surgical ligation. Peripheral embolisation occurred in 10 patients during the early learning period. All were successfully retrieved, and the ducts reoccluded during the same sitting except in 2 who had to undergo surgical ligation as the ducts were too large (Table 2). The only noted potential long-term complication was left pulmonary obstruction (velocity>:! m/set). This was noted in 7 patients, all except 1 in the Gianturco coil group, and the maximum velocity was 2.5 m/set. None had descending aortic velocity greater than 1.4 m/set. There were no episodes of endocarditis. We have not encountered cases of recanahsation during the study period.
In this study, we compared the outcome of 258 patients who received a Gianturco coil and 224 patients who received a Rashkind Umbrella device at a single centre. As shown in Table 1, there were no significant differences in patient characteristics between the 2 groups. The immediate occlusion rate was 78% in the Gianturco coil group compared to 60% in the Rashkind Umbrella group (Fig. 1). This concurs with the findings of Gala1 et al. The trend of further spontaneous closure within the next 3-6 months was significantly higher in the Gianturco coil group, leaving only 4% residual shunt as compared to 25% in the Rashkind Umbrella group at 6 months follow-up. The complete occlusion rate at 1 year was 97% and 78% in favor of the Gianturco coil. All patients who underwent a reocclusion procedure using the Gianturco coil demonstrated 100% immediate closure. With these findings and the cost benefits of reocclusion, we feel that irrespective of the initial device used, all residual shunts that persist beyond 6 months follow-up should be closed using coils.
Discussion Transcatheter occlusion of native PDA has been used in many centres as the first choice for the management for PDA.3,4,7,s,9J0.11Transcatheter occlusion using the Rashkind Umbrella device has been widely investigated, and there are several disadvantages when compared to the Gianturco coil. The large delivery system precludes its use in small children; it is more expensive than the standard surgical approach and, more importantly, has a high residual shunt of more than 20% at 1 year.4
The risk of embolisation during the procedure has been ascribed to the lack of a controlled-release mechanism of the coi1.7,*,9JaThis complication was also encountered in this study (2.7%), more so during the early phase when single catheter and smaller coils were used. The use of detachable coils may reduce the risk of coil embolisation.14 However, it does not abolish embolisation completely and in fact may add unnecessary cost to the patients.15
In most recent series, PDA occlusion using Gianturco coils has higher early complete occlusion rates than the Rashkind Umbrella device.6s8J0In our series, there was no significant difference in the duct size, and furthermore, Gianturco coils could be used in smaller children irrespective of ductal morphology.10 Limited experiences in selected groups of PDA (small PDA up to 3.3 mm) showed higher early occlusion rate compared to
In this series of Gianturco coil occlusion, the embolisation risk was markedly reduced to less than 1% after the introduction of the multiple catheter technique. In the Rashkind Umbrella group, a 2.6% incidence of
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Samion, Alwi, Latif, Kandavel, Lim, Zambahari Rashkind Umbrella and Gianturco coils
haemolysis occurred, reflecting the similar experience of Hayes.16 The absence of clinical haemolysis in the Gianturco coil group may be due to the feasibility of deploying multiple coils resulting in complete immediate occlusion in the majority of the cases. Left pulmonary artery obstruction is the only potential long-term complication, and this needs continuous assessment. There has been no evidence of progressive increase in flow velocity in any patients with left pulmonary obstruction, but follow-up so far extends only to 1 year.
3.
4.
5.
Khan MA, Yousef SA, 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 follow up. J Thorac Cardiovasc Surg 1992; 104: 1721-7. Hosking MC, Benson LN, Musewe NN, Dyek JD, Freedom RM. Transcatheter occlusion of the persistently patent ductus arteriosus occluder: forty-month follow up and prevalence of residual shunting. Circulation 1991;84:2313-7. Musewe NN, Benson LN, Smallhorn JF, Freedom RM. Twodimensional echocardiographic and colour flow Doppler evaluation of ductal
6.
Conclusion Ductal occlusion using the Gianturco coil for small to moderate native PDA is highly effective, safe and less expensive than the Rashkind device. It offers a better alternative regardless of the patient’s age except in infants who may require more than 2 coils. Although the risk of procedure related complications is small, significant left pulmonary artery obstruction is seen among infants, especially in those requiring multiple coils. Most residual shunts following coil occlusion close spontaneously within 3-6 months, but reocclusion procedures offer complete immediate secondary occlusion.
9.
More information needs to be obtained about the long-term consequences of left pulmonary artery obstruction in the growing child. We recommend Gianturco coils as the alternative to the Rashkind device for children with native PDA up to 4.5 mm.
12.
7.
occlusion
with
patent ductus arteriosus immediate and short-term 8.
the Rashkind
prosthesis.
Circulation
1989;80:1706-10. Llyod TR, Fedderly R, Mendelsohn AM, Sandhu SK, Beekman RH III. Transcatheter occlusion of patent ductus arteriosus with Gianturco coils. Circulation 1993;88: 1412-20. Hijazi ZM, Gegel RL. Results of antegrade transcatheter closure of using single or multiple Gianturco results. Am J Cardiol 1994;74:925-9.
coils:
Cambier PA, Kirby WC, Wortham DC, Moore JW. Percutaneous closure
of the small
(~2.5
mm)
patent ductus
arteriosus
using coil
embolization. Am J Cardiol 1992;69:815-6.
10.
11.
13.
The introduction of a purpose-designed ductal occluder (Amplatzer Ductal Occluder, AGA Medical Corporation, U.S.A.) has evolved as a promising device for occlusion of larger PDAs in a significant percentage of young infants negating the need for surgery.”
14.
Shim D, Fedderly RT, Beekman RH III, Ludomirsky A, Young ML, Schork MA, Llyod TR. Follow-up of coil occlusion of patent ductus arteriosus. J Am Co11 Cardiol 199&28:207-l 1. Gala1 0, De Mour M, Al Fadley F, Hijazi ZM. Transcatheter closure of the patent ductus arteriosus: comparison between the Rashkind occluder device and the antegrade Gianturco coils technique. Am Heart J 1996;131:368-72. Alwi M, Kang LM, Samion H, Latif HA, Kandavel G, Zambahari R. Transcatheter occlusion of native persistent ductus arteriosus using conventional Gianturco coils. Am J Cardiol 1997;79:1430-2. Krichencko A, Benson LN, Burrows P, Moes CAF, McLauglin P, Freedom RM. Angiographic classification of the isolated persistently patent ductus arteriosus and implications for percutaneous catheter occlusion. Am J Cardiol 1989;63: 877-80. Fddley R, Halees Z, Gala1 0, Kumar N, Wilson N. Left pulmonary artery stenosis: A serious complication of transcatheter occlusion of the persistent arterial duct. Lancet 1993;341:559-60.
Tometzki AJP, Walsh KP, Arnold R, Peart I, Bullock FA, Sreeram
N, Abdulhhamed JM, Godman MJ. Transcatheter occlusion of the patent ductus arteriosus with Cook detachable coils. Cardiol Young 1996;6(Suppl l):S6. 15. Zeevi B, Berant M, Bar-Mor Galit, Blieden LC. Percutaneous closure of small patent ductus arteriosus using occluding spring
References
coils and a snare. Cardiol Young 1996;6:327-3 1.
1. Rashkind WJ, Mullins CE, Hellenbrand WE, Tait MA. Non surgical closure of patent ductus arteriosus: clinical application of Rashkind PDA occluder system. Circulation 1987;75:583-92. 2. Dick JD, Benson LN, Smallhorn JF, McLaughlin PR, Freedom RM, Rowe RD. Catheter occlusion of the persistently patent ductus arteriosus. Am J Cardiol 1988;62:1089-92.
16. Hayes AM, Redington AN, Rigby ML. Severe haemolysis after transcatheter duct occlusion; a non surgical remedy. Brit Heart J 1992;67:321-2. 17. Sharafuddin MJ, Gu X, Titus JL, et al. Experimental evaluation of a new self-expanding patent ductus arteriosus occluder in canine model. JVIR 1996;7:877-87.
Published by MLtee Medical Publishing on behalf of The Australasian Society of Cardiac and Thoracic Surgeons. Mi-tee Media Pty Ltd (A.C.N. 053 106 497), PO Box 24, Camberwell, Victoria, 3124, Australia. Advertising enquiries and business correspondence: Calvin Miller, Publisher, Mi-tee Media Pty Ltd, telephone 03-9890-1766; facsimile: 03-9898-9944, international telephone 61-3-9890-1766; international facsimile 61-3-9898-9944. Subscriptions: Write to the Secretary, The Asia Pacific Heart Journal, PO Box 6492, Melbourne, Victoria, 8008, Australia (fax: 039521-1362). Members of The Australasian Society of Cardiac and Tboracic Surgeons receive their copies as part of their membership. Aims and scope: The Journal aims to provide a forum for publication of scientific articles and for communication among cardiac and thoracic surgeons and physicians, primarily throughout the Asia Pacific region. Copyright: All rights reserved. No part of this publication may be reproduced without the written permission of the Editor. The editors, The Australasian Society of Cardiac and Thoracic Surgeons, and Mi-tee Media Pty Ltd disclaim responsibility for any injury to persons or property as a matter of products liability or from use of any methods, procedures, products, instructions or concepts contained in this Journal. The editors, the Society and Mi-tee Media Pty Ltd recommend that independent verification be made of any drug dosage or procedure before use in any patient. Statements and opinions expressed in communications in the Journal are those of the authors and not necessarily those of the editors, the Society or of Mi-tee Media Pty Ltd.
10.5
Mazeni Alwi, MRCP, Haifa A. Latif, MD, Geetha Kandavel, Kang M. Lim, MRCP, Robaayah Zambahari, FRCP, FACC MD,
MRCP,
Institut Jantung Negara (National Heart Institute), Kuala Lumpur, Malaysia Background: The Rashkind Umbrella device has proven effective in closing small to moderate
size patent ductus arteriosus. A comparable early occlusion rate was also seen in PDA occlusion using Gianturco coils. This study addresses the long-term outcome of both techniques in a single centre. Methods: Review was undertaken of 522 patients with PDA who underwent transcatheter occlusion before January 1997; 244 patients (mean: age 8.Ok6.7 years, weight 21.8k12.9 kg, PDA size 3.2kl.O mm) were intended to receive the Rashkind Umbrella device and the remaining 278 patients (mean: age 6.4k5.6 years, weight 18.6f11.2 kg, PDA size 2.5fl.O mm) would receive Gianturco coils. Deployment failure occurred in 8 patients (3%) and 6 (2%) during the initial learning curve of the Rashkind Umbrella and Gianturco coil, respectively. In the Rashkind Umbrella group, haemolysis occurred in 6, device embolisation in 3, and 1 patient died from anaesthetic sequelae. Peripheral pulmonary embolisation of coils occurred in 7 patients and all were successfully retrieved. Results: Results were analysed from 228 and 258 patients who had successful Rashkind Umbrella device and Gianturco coil deployment respectively. All had completed at least 1 year follow-up. They were evaluated clinically for residual ductal murmur and echocardiographically for a residual ductal shunt and presence of pulmonary artery or aortic obstruction. The Rashkind Umbrella group had significantly higher residual shunt compared to the Gianturco coil group at various stages of follow-up (pcO.O5), 40% v 22% at 24 hours, 29% v 7% at 3 months, 25% v 4% at 6 months and 22% v 3% at 1 year. In 57 patients, a reocclusion procedure during the study period was undertaken to effect immediate complete occlusion. Mild left pulmonary artery stenosis (velocity>2 m/s) was noted in 6 patients who had multiple coils and one who had a 17 mm Rashkind Umbrella device. Conclusions: Transcatheter occlusion of PDA using the Gianturco coil is safer and more effective than the Rashkind Umbrella device. It has become the first choice for treating small to moderate size native PDA at our institution. (Asia Pacific Heart J 1999; 8(2):102-105) Introduction
procedure.s+lO This study analyses the comparative clinical outcome of the Rashkind Umbrella device and the Gianturco coil involving 522 patients with native PDA who underwent a single initial occlusion procedure at one institution.
Transcatheter occlusion of small to moderately large native PDA has been shown to be safe and effective with conventional surgical ligation reserved for a large PDA or symptomatic infants. Amongst these purpose-designed devices, the Rashkind Umbrella device was the most extensively used and investigated in many centres.Q7s~4 This technique involves the delivery of occluder devices via a large delivery sheath (8F or 11F) that limits its use in small children. It also has a relatively high incidence of residual shunt (20%-38%) at 1 year.4,5
Methods Between June 1992 and December 1996,522 patients with native PDA underwent unrandomised transcatheter occlusion at the National Heart Institute, Kuala Lumpur, and were retrospectively reviewed. They had been followed-up for at least 1 year. All patients, of whom the majority were asymptomatic, had typical clinical signs of PDA which was confiied by echocardiography. At our centre, the Rashkind Umbrella device was introduced in June 1992 for small to moderate native PDA, and the Gianturco coil in April 1994, initially for residual shunt following either Rashkind Umbrella device occlusion or
On the other hand, over the past 4-5 years, a nonpurpose-designed conventional Gianturco coil has been shown to be a good alternative ‘device’.6S7Ss79 It is easily introduced via a small (4F) catheter making it feasible and safe in smaller children. The early occlusion rate is comparable and, more importantly, it is a less expensive
102
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Table 1. Clinical data.
patients. Of these, 215 (83%) patients received 2 or more coils, with a mean of 2.7 coils per patient. There was no statistical difference in terms of the clinical data between the two groups (Table 1). Although the mean PDA diameter in the coil group appeared smaller (2.5kl.O mm) compared to the Rashkind Umbrella group, they were not statistically significant (p>O.O5). The median follow-up was 46 months (range, 30 to 74) in the Rashkind Umbrella group compared to 30 months (range, 20 to 44) in the Gianturco coil group.
RashlcindUmbrella device Gianturco coil n=244 n=258 Age (years) Weight (kg) PDA size(mm) Screening(min) Device Follow-up (median)
8.0f6.7 21.8f12.9 3.2kl.O 11Sf10.0 146 (60%) size 17 mm 98 size 12 mm
6.4+5.6 18.6f11.2 2.5fl .o 13.6+11.0 215 (83%) > 2 coils 2.7fl.2 per patient
46 (30-74) months
3 1 (20-44) months
Exclusion from clinical outcome analysis Thirty-six patients (7%) were excluded from analysis for various reasons. Deployment failure occurred in 8 patients in the Rashkind Umbrella group, and they subsequently underwent surgical ligation. In the coil group, 6 patients underwent occlusion with the Rashkind Umbrella device following unsuccessful occlusion prior to the use of multiple catheters technique.
Data are presented as mean&SD. There were no statistical differences in age, body weight, PDA size and screening time between the 2 groups. surgical ligation, but these patients were not included in the study. The Rashkind device was no longer available by June 1996. Methods for Rashkind Umbrella device implantation were well established,l,*s” whilst the technique of Gianturco coil occlusion using antegrade multiple catheters in our laboratory has been previously described.rr The narrowest diameter of the ducts was measured following aortic angiography. As a guideline, 3.5 mm duct diameter was the cut-off point in selecting either the 12 mm or 17 mm Rashkind Umbrella device. In the early learning phase, only small PDAs were occluded using single catheter technique and smaller coils (5 mm). The multiple catheters technique was subsequently used for up to 5.0 mm PDA. The following guideline for Gianturco coil occlusion was used: 1 coil for ducts less than 1.5 mm, 2 coils for 1.6-2.5 mm, 3 coils for 2.6-3.5 mm, 4 coils for 3.6-4.0 mm, and 5 or more coils for ducts larger than 4.0 mm. No attempts were made to occlude ducts larger than 5.0 mm in diameter.
Rashkind Umbrella device embolisation to peripheral pulmonary artery occurred in 3. All were successfully retrieved prior to surgical ligation in 2, and reocclusion in 1. A total of 7 early reocclusion procedures (within 7 days) were performed, for haemolysis in 4 and geographical reasons in 3. Two patients who developed severe haemolysis underwent surgical removal of an umbrella device and ligation of the PDA. There was 1 anaesthetic death unrelated to the Rashkind Umbrella occlusion procedure. Ten patients were excluded for incomplete follow-up. Of these, 6 had shown complete occlusion whilst 4 had systolic residual shunt murmur and continuous shunt on colour flow mapping at the 24-hour assessment. Occlusion rate The clinical outcome results were analysed from 486 patients (228 Rashkind Umbrella group, 258 Gianturco coil group) who had a successful single occlusion procedure. The Rashkind Umbrella group had significantly higher residual shunt compared to the Gianturco coil group at various stages of follow-up (Fig. 1). At 24 hours, residual shunts were present in 22% of the Gianturco coil group, compared to 40% in the Rashkind Umbrella group. The maximum occlusion rate of more than 95% was achieved 6 months after coil occlusion compared to the Rashkind Umbrella group which had a more gradual increase in occlusion rate. During the study period, there were 57 reocclusion procedures in 53 patients (12%) with immediate complete occlusion. Ten (18%) of these were performed at between 6 months and 1 year of follow-up for significant residual shunt with continuous murmur. The remainder, who had a systolic murmur and a continuous shunt signal on colour flow mapping or CW doppler, were performed after 1 year of follow-up. Seven of these 10 patients were from the Rashkind Umbrella group and required an additional Rashkind Umbrella device. The
No patient was excluded on the basis of ductus morphology. 12 The procedure was performed under general anaesthesia in smaller children. Heparinisation (50 U/kg) after cannulation and intravenous cefuroxime (30 mg/kg) prior to device deployment were routinely given. Clinical examination, chest X-ray examination and echocardiography were done 24 hours before discharge and subsequently at 3 months, 6 months and 1 year, specifically to look for residual shunt and presence of left pulmonary artery or aortic obstruction.‘3 An option for reocclusion was offered if a clinical residual shunt (continuous or systolic murmur) and confirmed by colour flow mapping which persisted after 6 months of followup. Reocclusion was not offered for silent residual shunt detected by colour flow mapping. Results Clinical data In the Rashkind Umbrella group, 146 17-mm 12-mm devices were deployed in 244 children. Gianturco coil group, a total of 688 coils with diameters of 5 mm and 8 mm were deployed
Alwi, Latif, Kandavel, Lim, Zambahari Rashkind Umbrella and Gianturco coils
and 98 In the helical in 258
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Table 2. Complications.
Rashkind device n=244
Haemolysis* Embolisation** Anaesthetic death WA stenosis***
Gianturco coil n=278
Total n=522
6 (2%) 3 (1%)
0 (0) 7 (3%)
1 (0.5%) 3 (1%)
0 (0)
10 (2%) 1 (0.2%)
5 (2%)
8 (2%)
25
6 (1.2%)
* Four of the 6 patients who had haemolysis underwent early second device occlusion, and the remaining 2 underwent surgicalremoval and ligation. ** All embolised device/coils in 10 patients were easily retrieved and 2 underwent surgical ligation whilst 8 were successfullyreoccluded with device/coils. *** Peak flow velocity>2.0 m/set.
Follow
up duration
Fig. 1. Incidence of residual shunt, assuming no reocclusion
procedure in 10 patients and the residual shunt persisted at lyear follow-up.
remaining 3 patients were from the coil group, and defects were closed using coils. Without a reocclusion procedure, the prevalences of residual shunts at 1 year were 3% and 22%, respectively, in favor of the Gianturco coil over the Rashkind device.
Rashkind Umbrella device.@ The immediate and 24 hours occlusion rate was significantly higher in larger PDAs occluded using coils in a randomised age-matched control study.10
Complications The overall complication rate was less than 5% (Table 2). Six patients developed haemolysis. These patients were from the Rashkind Umbrella group, requiring a second device or surgical ligation. Peripheral embolisation occurred in 10 patients during the early learning period. All were successfully retrieved, and the ducts reoccluded during the same sitting except in 2 who had to undergo surgical ligation as the ducts were too large (Table 2). The only noted potential long-term complication was left pulmonary obstruction (velocity>:! m/set). This was noted in 7 patients, all except 1 in the Gianturco coil group, and the maximum velocity was 2.5 m/set. None had descending aortic velocity greater than 1.4 m/set. There were no episodes of endocarditis. We have not encountered cases of recanahsation during the study period.
In this study, we compared the outcome of 258 patients who received a Gianturco coil and 224 patients who received a Rashkind Umbrella device at a single centre. As shown in Table 1, there were no significant differences in patient characteristics between the 2 groups. The immediate occlusion rate was 78% in the Gianturco coil group compared to 60% in the Rashkind Umbrella group (Fig. 1). This concurs with the findings of Gala1 et al. The trend of further spontaneous closure within the next 3-6 months was significantly higher in the Gianturco coil group, leaving only 4% residual shunt as compared to 25% in the Rashkind Umbrella group at 6 months follow-up. The complete occlusion rate at 1 year was 97% and 78% in favor of the Gianturco coil. All patients who underwent a reocclusion procedure using the Gianturco coil demonstrated 100% immediate closure. With these findings and the cost benefits of reocclusion, we feel that irrespective of the initial device used, all residual shunts that persist beyond 6 months follow-up should be closed using coils.
Discussion Transcatheter occlusion of native PDA has been used in many centres as the first choice for the management for PDA.3,4,7,s,9J0.11Transcatheter occlusion using the Rashkind Umbrella device has been widely investigated, and there are several disadvantages when compared to the Gianturco coil. The large delivery system precludes its use in small children; it is more expensive than the standard surgical approach and, more importantly, has a high residual shunt of more than 20% at 1 year.4
The risk of embolisation during the procedure has been ascribed to the lack of a controlled-release mechanism of the coi1.7,*,9JaThis complication was also encountered in this study (2.7%), more so during the early phase when single catheter and smaller coils were used. The use of detachable coils may reduce the risk of coil embolisation.14 However, it does not abolish embolisation completely and in fact may add unnecessary cost to the patients.15
In most recent series, PDA occlusion using Gianturco coils has higher early complete occlusion rates than the Rashkind Umbrella device.6s8J0In our series, there was no significant difference in the duct size, and furthermore, Gianturco coils could be used in smaller children irrespective of ductal morphology.10 Limited experiences in selected groups of PDA (small PDA up to 3.3 mm) showed higher early occlusion rate compared to
In this series of Gianturco coil occlusion, the embolisation risk was markedly reduced to less than 1% after the introduction of the multiple catheter technique. In the Rashkind Umbrella group, a 2.6% incidence of
104
Asia Pacific Heart J 1999;8(2)
Samion, Alwi, Latif, Kandavel, Lim, Zambahari Rashkind Umbrella and Gianturco coils
haemolysis occurred, reflecting the similar experience of Hayes.16 The absence of clinical haemolysis in the Gianturco coil group may be due to the feasibility of deploying multiple coils resulting in complete immediate occlusion in the majority of the cases. Left pulmonary artery obstruction is the only potential long-term complication, and this needs continuous assessment. There has been no evidence of progressive increase in flow velocity in any patients with left pulmonary obstruction, but follow-up so far extends only to 1 year.
3.
4.
5.
Khan MA, Yousef SA, 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 follow up. J Thorac Cardiovasc Surg 1992; 104: 1721-7. Hosking MC, Benson LN, Musewe NN, Dyek JD, Freedom RM. Transcatheter occlusion of the persistently patent ductus arteriosus occluder: forty-month follow up and prevalence of residual shunting. Circulation 1991;84:2313-7. Musewe NN, Benson LN, Smallhorn JF, Freedom RM. Twodimensional echocardiographic and colour flow Doppler evaluation of ductal
6.
Conclusion Ductal occlusion using the Gianturco coil for small to moderate native PDA is highly effective, safe and less expensive than the Rashkind device. It offers a better alternative regardless of the patient’s age except in infants who may require more than 2 coils. Although the risk of procedure related complications is small, significant left pulmonary artery obstruction is seen among infants, especially in those requiring multiple coils. Most residual shunts following coil occlusion close spontaneously within 3-6 months, but reocclusion procedures offer complete immediate secondary occlusion.
9.
More information needs to be obtained about the long-term consequences of left pulmonary artery obstruction in the growing child. We recommend Gianturco coils as the alternative to the Rashkind device for children with native PDA up to 4.5 mm.
12.
7.
occlusion
with
patent ductus arteriosus immediate and short-term 8.
the Rashkind
prosthesis.
Circulation
1989;80:1706-10. Llyod TR, Fedderly R, Mendelsohn AM, Sandhu SK, Beekman RH III. Transcatheter occlusion of patent ductus arteriosus with Gianturco coils. Circulation 1993;88: 1412-20. Hijazi ZM, Gegel RL. Results of antegrade transcatheter closure of using single or multiple Gianturco results. Am J Cardiol 1994;74:925-9.
coils:
Cambier PA, Kirby WC, Wortham DC, Moore JW. Percutaneous closure
of the small
(~2.5
mm)
patent ductus
arteriosus
using coil
embolization. Am J Cardiol 1992;69:815-6.
10.
11.
13.
The introduction of a purpose-designed ductal occluder (Amplatzer Ductal Occluder, AGA Medical Corporation, U.S.A.) has evolved as a promising device for occlusion of larger PDAs in a significant percentage of young infants negating the need for surgery.”
14.
Shim D, Fedderly RT, Beekman RH III, Ludomirsky A, Young ML, Schork MA, Llyod TR. Follow-up of coil occlusion of patent ductus arteriosus. J Am Co11 Cardiol 199&28:207-l 1. Gala1 0, De Mour M, Al Fadley F, Hijazi ZM. Transcatheter closure of the patent ductus arteriosus: comparison between the Rashkind occluder device and the antegrade Gianturco coils technique. Am Heart J 1996;131:368-72. Alwi M, Kang LM, Samion H, Latif HA, Kandavel G, Zambahari R. Transcatheter occlusion of native persistent ductus arteriosus using conventional Gianturco coils. Am J Cardiol 1997;79:1430-2. Krichencko A, Benson LN, Burrows P, Moes CAF, McLauglin P, Freedom RM. Angiographic classification of the isolated persistently patent ductus arteriosus and implications for percutaneous catheter occlusion. Am J Cardiol 1989;63: 877-80. Fddley R, Halees Z, Gala1 0, Kumar N, Wilson N. Left pulmonary artery stenosis: A serious complication of transcatheter occlusion of the persistent arterial duct. Lancet 1993;341:559-60.
Tometzki AJP, Walsh KP, Arnold R, Peart I, Bullock FA, Sreeram
N, Abdulhhamed JM, Godman MJ. Transcatheter occlusion of the patent ductus arteriosus with Cook detachable coils. Cardiol Young 1996;6(Suppl l):S6. 15. Zeevi B, Berant M, Bar-Mor Galit, Blieden LC. Percutaneous closure of small patent ductus arteriosus using occluding spring
References
coils and a snare. Cardiol Young 1996;6:327-3 1.
1. Rashkind WJ, Mullins CE, Hellenbrand WE, Tait MA. Non surgical closure of patent ductus arteriosus: clinical application of Rashkind PDA occluder system. Circulation 1987;75:583-92. 2. Dick JD, Benson LN, Smallhorn JF, McLaughlin PR, Freedom RM, Rowe RD. Catheter occlusion of the persistently patent ductus arteriosus. Am J Cardiol 1988;62:1089-92.
16. Hayes AM, Redington AN, Rigby ML. Severe haemolysis after transcatheter duct occlusion; a non surgical remedy. Brit Heart J 1992;67:321-2. 17. Sharafuddin MJ, Gu X, Titus JL, et al. Experimental evaluation of a new self-expanding patent ductus arteriosus occluder in canine model. JVIR 1996;7:877-87.
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