Safety and Efficacy of Using 0.052-inch Gianturco Coil for Closure of Large (>= 4 mm) Patent Ductus Arteriosus

Transcatheter closure of a small patent ductus arteriosus (PDA) is now an established treatment in many pediatric cardiology centers. As for occlusion of large PDA, interventional cardiologists are still looking for a simple, but safe and effective procedure. There are several reports using various devices and novel techniques for occlusion of large PDA.1–5 Although the procedures are effective approaches, some use expensive devices and some require exquisitely complex techniques. The increased costs and technical difficulty prevent their widespread use by interventional cardiologists. Transcatheter coil occlusion of PDA, which was developed by Dr. Cambier and colleagues in 1992,6 is a relatively safe, effective and low-cost procedure. However, this technique has significant limitations when used to close large PDA. In our hospital, transcatheter coil occlusion of PDA has become a preferred therapeutic choice. For large PDA, we consider the sturdier 0.052´´ coil to be a useful device for closure of large defects. The 0.052´´ Gianturco coils (Cook Cardiology, Inc., Bloomington, Indiana) are constructed from heavier gauge wire than the 0.038´´ Gianturco coils. During deployment, the 0.052´´ coil also winds more tightly and maintains its loop configuration more efficiently than the commonly used 0.038´´ coil. Therefore, the implanted 0.052´´ coil will be seated in the ductal ampulla more efficiently than the 0.038´´ coil. We performed several cases of transcatheter closure of large PDA using the 0.052´´ Gianturco coils, with a success rate of 86.7%. We believe the use of 0.052´´ coil provides an effective and easy way to close large PDA. This study reports our experience and evaluates the safety and efficacy of using 0.052´´ coil with the multiple-coil strategy for the closure of large PDA. Methods From August 1997 to March 2001, a total of 208 patients underwent transcatheter coil occlusion of PDA in our hospital. Of these, fifteen patients had PDA >= 4 mm in minimal diameter and received at least one 0.052´´ coil implantation for PDA. These 15 patients constituted our study group. Patient age at the time of PDA closure, minimal diameter of the ductus, diameter of the ampulla, Qp/Qs, and incidence of complications were analyzed. Patient ages ranged from 10 months to 44 years (mean, 11.2 years). Weights ranged between 8.8–54 kg (mean, 29.2 kg). All 15 patients had undergone at least one 0.052´´ coil implantation attempt for PDA. The characteristic findings of these 15 patients were clinical and echocardiographic features of large PDA, asymptomatic adolescent or adult with PDA measuring >= 4 mm on color flow echocardiography. PDAs were typed according to the classification described by Krischenko et al.7 Anesthesia was achieved with a combination of intravenously administered ketamine and midazolam. All patients received 50 units/kg intravenous heparin after insertion of a femoral arterial sheath to avoid the risk of femoral arterial thrombosis. All patients underwent color Doppler echocardiography before leaving the catheterization laboratory, and at one day and three months post-procedure. Hemodynamic data were collected first; aortic angiography was then performed and ductal size was measured in the lateral projection using the angiographic catheter as a reference. Upon measuring the minimal ductal size and taking the ampulla diameter into account, a 0.052´´ coil was selected due to assumed poor stability of 0.038´´ coil for large PDA. The diameter of the coil was at least 1.8 times the minimal PDA diameter and the coil was long enough to produce at least four complete loops. In addition, the coil diameter was less than or equal to the ductal ampulla diameter. Coil implantation was performed initially via the retrograde arterial approach in the first three cases. Due to one reported severe complication in the early experience,8 we adopted transvenous antegrade delivery of 0.052´´ coil as our approach for coil implantation. Transvenous coil implantation using 0.052´´ Gianturco coil was performed using a 6 French (Fr) USCI right heart guiding catheter (Bard, Inc., Billerica, Massachusetts) advanced from the pulmonary trunk, across the ductus, and into the descending aorta. The catheter was then exchanged for a 7 Fr Torcon NB® Advantage guiding catheter (Cook Cardiology, Inc.) for 0.052´´ coil delivery. The coil was advanced through the end-hole catheter using the stiff end of a 0.038´´ guidewire (Cook Cardiology, Inc.). Under fluoroscopic guidance, at least 2 1/2 loops of coil were advanced out of the catheter into the descending aorta (DAo). The end-hole catheter with the wire was then brought back into the ductal ampulla. The end-hole catheter was withdrawn over the wire into the main pulmonary artery (PA), which leaves the rest of the coil on the PA side of the ductus. Occasionally, we use the balloon occlusion techniques described by Dalvi et al. to prevent coil embolization.9 One patient with a large, type E PDA successfully received two simultaneous 0.052´´ coil implantations via antegrade and retrograde delivery of coils. Otherwise, additional 0.038´´ coils were placed by transvenous or transarterial delivery for complete closure of the PDA. After coil implantation of the PDA was accomplished, color Doppler echocardiography (GE Corporation, VingMed Ultrasound System Five) was performed to analyze whether residual shunt was present. Residual shunts were graded by echocardiography and defined as follows: no shunt was defined by no flow of color Doppler echo from DAo to PA; trivial residual shunt was defined by a tiny jet of color Doppler flow measuring 1 mm. If the shunt was trivial to mild, reposition of the coil by Judkins right coronary artery catheter was performed to seat the coil to optimal position in order to eliminate the shunt. Reposition was achieved by pushing the catheter against the coil. After several attempts to reposition the coil, further echocardiography was performed to confirm that the shunt was eliminated. For mild to significant residual shunt, additional coils were delivered to close the shunt. Once again, reposition was attempted if the shunt was trivial after additional coils were implanted until no residual shunt was present. Every effort was made to ensure that the shunt was closed as completely as possible. Closure of PDA was considered successful if no residual shunt or trivial residual shunt was found by echocardiography. Results Clinical data of the fifteen patients are listed in Table 1. All 15 patients had the PA pressure measured. Only 3 patients had mild elevation of the systolic pressure (PA systolic pressures of 35, 46, and 48 mmHg). In the other 12 patients, the PA systolic pressure ranged from 16–25 mmHg (mean, 22.6 mmHg). The Qp/Qs ranged from 1.5–3.5 (mean, 2.4). Mean fluoroscopic time was 20.1 minutes (range, 16.8–56.0 minutes). Transcatheter coil closure of PDA was successful in 13/15 patients (86.7%). Successful single 0.052´´ coil occlusion of PDA was achieved in 4 patients. The other 9 patients received at least 2 coils to completely close the PDA. There was no coil embolization immediately after coil deployment. Seven patients with trivial to mild residual shunt immediately after coil implantation had no shunts during late follow-up. One patient needed another coil implantation several days later to achieve shunt closure. Only 5 patients had shunt closure immediately after coil implantation. One patient with a large, type E PDA underwent single 0.052´´ coil implantation. There was a trivial residual shunt immediately after coil implantation. Unfortunately, late coil migration to the left pulmonary artery (LPA) was found during treatment for femoral artery thrombosis. This patient finally received surgical removal of the coil and ligation of the PDA with uneventful recovery. This case happened during the early learning curve while using the retrograde approach to deliver the 0.052´´ coil. Eight patients received 2 coils and one patient received 3 coils for closure of PDA. One patient received simultaneous delivery of two 0.052´´ coils via antegrade and retrograde routes. Although the intermingled coils were a relatively large complex, there was no obstruction of arterial flow. Immediately after coil implantation, there was a trivial shunt; it closed 1 day later and remained closed at follow-up. The only patient who received 3 coils for PDA occlusion showed no residual shunt immediately after coil implantation, nor was there obstruction to LPA or DAo flow. We repositioned the coil in all 15 patients, which resulted in successful closure of the PDA in 12 patients after the reposition procedure. One patient received another coil implantation to eliminate hemolysis and completely close the PDA. Follow-up color Doppler echo of the 13 patients with coil implantation of the PDA revealed complete closure 3 months later. Two patients developed severe hemolysis after coil implantation. One patient who received single coil implantation had trivial residual shunt after coil delivery. Several attempts to reposition the coil only amended the trivial shunt, but could not eliminate it. Unfortunately, hemolysis developed several hours later and color Doppler echo revealed a significant shunt. This patient received a blood transfusion, but hemolysis continued. She later received another coil implantation that completely closed the shunt. Hemolysis resolved without further complication. The other patient had two coils placed, but had hemolysis shortly after coil implantation. Efforts to implant another coil failed; he underwent surgical removal of the coils and ligation of the PDA. There were 4 complications in this study, including the case of coil embolization to the PA. All of the patients except the aforementioned 2 cases had complete coil closure of the PDA at a mean follow-up of 12.7 ± 4.6 months (range, 3–38 months). On follow-up color Doppler echocardiogram, all coils were in the same position as immediately after the implantation procedure. None of the 13 patients had left pulmonary artery stenosis, coarctation of the aorta, hemolysis, infected arteritis or thromboembolism. Two patients received surgical ligation of the ductus. Their PDA shunts were closed completely after surgery. One patient who received a second coil implantation to eliminate hemolysis showed no sign of recurrent hemolysis. The patient’s PDA was successfully closed by coils during follow-up. Discussion Successful coil occlusion of large PDA (>= 4 mm in diameter) was achieved in 86.7% of the patients in this study. There were 4 complications and only 2 patients had to undergo surgical ligation of their PDA. These 4 complications happened during the early portion of the learning curve. Compared with surgical closure of PDA, the results were not satisfactory, but acceptable. There were no surgery-associated complications while using transcatheter techniques to close PDA. Transcatheter closure of PDA using Gianturco coil is now a common practice in many pediatric cardiology centers. Due to the easy deployment and cost-effectiveness, most interventional cardiologists choose this method to close PDA. Many studies found that the transcatheter coil occlusion method for small PDA had high success rates (range, 83–100%).10–14 The follow-up data by Shim et al. supported transcatheter coil closure of PDA as a justifiable treatment.15 Their study described a 20-month complete closure rate of 94% with Gianturco coils. Nevertheless, coil implantation was difficult for large PDA due to lack of stability and easy migration. A strong coil that can hold its place in the ductus without damage to the vessel wall is preferable. A 0.052´´ coil provides a stiff device that is readily recoiled to its helical configuration during deployment, and is highly recommended for this procedure. Owada et al.16 supported the use of the 0.052´´ coil because it reduced the incidence of embolization, and also reduced the number of coils needed for closure of large PDA. Hence, for coil occlusion of large PDA, 0.052´´ Gianturco coil is the first choice in our practice. The low incidence of embolization and high closure rate reported in our study support this point of view. In our study, residual shunts immediately after the procedure were not uncommon after 0.052´´ coil implantation for large PDA (10 of 15 patients). Two patients developed hemolysis after coil implantation. In one case, the residual PDA shunt was trivial at first; the patient developed hemolysis when the shunt became significant one day after coil implantation. We assumed that the stiffness of the 0.052´´ coil might distort the shape of the ductus, which might make the residual shunt become significant later. We had noticed that the hemolytic incidence was high (2/15 patients) using the 0.052´´ coil for closure of large PDA and left with significant residual shunt. Therefore, it is important to close the PDA shunt as completely as possible if choosing the 0.052´´ coil. We adopted the method described by Rothman et al. to reposition the implanted coil by pushing against it until the shunt was closed.12 To optimize coil position in the ductal ampulla, several tries should be attempted until the coil is properly seated. These manipulations may prolong the fluoroscopy time. However, reposition maneuvers help minimize the shunt during the procedure. To avoid excessive roentgen doses, we used color Doppler echocardiography to evaluate the ductal patency during the procedure. Maximum effort should be made to completely close the PDA shunt on color Doppler echo study. We found that single 0.052´´ coil implantation was rarely able to close large PDA shunts. The multiple coil strategy described by Zellers et al. showed promising results.10 Their report suggests that complete closure of PDA by multiple coils is feasible and poses no danger to the adjacent vessels. We adopted their “multiple coil-no residual shunt” strategy in addition to the 0.052´´ coil to close large PDA. Our study indicated that the use of even two 0.052´´ Gianturco coils does not jeopardize the left pulmonary artery or the adjacent aorta. Complete closure of the large PDA shunt can be achieved by using the 0.052´´ coil and the multiple coil strategy. There are some drawbacks to this technique. The catheter used for coil deployment was size 7 Fr, which is too large for a small infant. In one previously reported case, the femoral vessel was compromised after successful implantation of the coil. During the use of urokinase for thrombolytic therapy of femoral artery occlusion, the coil embolized to the distal PA. Another disadvantage is that the stiffness of the 0.052´´ coil might stretch the PDA and change the shape of the ductus. Because the contour of the PDA was distorted, shunt may become significant if coil occlusion is not complete. Hemolysis developed once the PDA shunt became significant. Hemolysis due to persistent shunt could be eliminated only after the shunt was completely closed. In this study, hemolysis was cured after one case of surgically ligated PDA and one case of further implantation of another coil. If, unfortunately, the coil embolized to the distal artery during the implantation procedure, the size and stiffness of the 0.052´´ coil would not be easy to retrieve. Fortunately, no coil embolized to the distal artery immediately after implantation in this study. The case with coil embolization to the distal PA was due to late coil migration. The coil embolized to the distal site several days after implantation. At that point in the study, the transvenous approach was adopted and no further compromise of the femoral vessel was found. In conclusion, our study supports the use of 0.052´´ coil for safe and effective transcatheter closure of large PDA. When combined with the use of the multiple coil strategy, the closure rate is 86.7%. With careful repositioning, any residual shunt can be eliminated or minimized during the same procedure. We suggest the use of 0.052´´ coil as an alternative method to treat large PDA.

1. Rao PS, Sideris EB, Haddad J, et al. Transcather occlusion of patent ductus arteriosus with adjustable buttoned device: Initial clinical experience. Circulation 1993;88:1119–1126. 2. Sievert H, Niemoller E, Franz K, et al. Detachable balloon technique for transvenous closure of patent ductus arteriosus. J Intervent Cardiol 1994;7:25–32. 3. Grifka RG, Mullins CE, Gianturco C, et al. New Gianturco-Grifka vascular occlusion device: Initial study in a canine model. Circulation 1995;91:1840–1846. 4. Schrader R, Hofstetter R, Fassbender D, et al. Transvenous closure of patent ductus arteriosus with Ivalon plugs. Multicenter experience with a new technique. Invest Radiol 1999;34:65–70. 5. Bilkis AA, Alwi M, Hasri S, et al. The Amplatzer duct occluder: Experience in 209 patients. J Am Coll Cardiol 2001;37:258–261. 6. Cambier PA, Kirby WC, Wortham DC, Moore JW. Percutaneous closure of the small (less than 2.5 mm) patent ductus arteriosus using coil embolization. Am J Cardiol 1992;69:815–816. 7. Krichenko A, Benson LN, Burrows P, et al. Angiographic classification of the isolated, persistently patent ductus arteriosus and implications for percutaneous catheter occlusion. Am J Cardiol 1989;63:877–880. 8. Huang TC, Hsieh KS, Lee CL. Late coil migration due to thrombolysis after successful implantation of a coil for persistent ductus arteriosus. Cathet Cardiovasc Intervent 2000;50:334–336. 9. Dalvi B, Nabar A, Goyal V, et al. Transcatheter closure of patent ductus arteriosus in children weighing or = 3.5 mm) patent ductus arteriosus. J Am Coll Cardiol 1997;30:1856–1862.