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TECHNICAL TIPS FOR PAEDIATRIC CARDIOLOGY AND CARDIAC SURGERY-5Catheter Closure of Moderate- to Large-Sized Patent Ductus Arteriosus Using the New Amplatzer Duct Occluder

: Immediate and Short-Term ResultsJOZEF MASURA, MD, PHD, KEVIN P. WALSH, MD, MRCP,* BASIL THANOPOULOUS, MD,†CHEN CHAN, MD,‡ JOHN BASS, MD,§ YOUSEF GOUSSOUS, MD, FACC\, PAUL GAVORA, MD,ZIYAD M. HIJAZI, MD, MPH, FACC¶ Bratislava, Slovak Republic; Liverpool and Leicester, England, United Kingdom; Athens, Greece; Minneapolis, Minnesota; Amman, Jordan; and Boston, Massachusetts Objectives The aim of this study was to assess the immediate and short-term results of anterograde catheter closure of a moderate- to large-sized patent ductus arteriosus (PDA) using the new self-expandable, respositionable Amplatzer duct occluder(ADO) device. Background. Transcatheter closure of a PDA using devices or coils is technically challenging and may be accompanied by a 38% incidence of residual shunts. Methods. Twenty-four patients (6 male, 18 female) underwent attempted transcatheter closure of a PDA using the ADO at a median age of 3.8 years (range 0.4 to 48) and a median weight of 15.5 kg (range 6 to 70). The mean PDA diameter at its narrowest segment was 3.7 6 1.5 mm. A 6F long sheath was used for delivery of the ADO. Follow-up evaluation was performed with color flow mapping of the main pulmonary artery within 24 h and at 1 and 3 months after closure. Results. Twenty three of the 24 patients had successful device placement. Angiography showed that 7 patients had complete immediate closure, 14 had a trace shunt (foaming through the device with no jet), and 2 had a small residual shunt (with a jet). Within 24 h, color Doppler revealed complete closure in all patients. The unsuccessful attempt was during an initial trial with a prototype that has been modified. The median fluoroscopy time was 13.5 min (range 6.3 to 47). All patients were discharged home the next day. There were no complications. Of the 23 patients, 21 completed the 1-month follow-up, all (95% confidence interval [CI] 86% to 100%) with complete closure, and 18 of 23 patients completed the 3-month follow-up, also all (95% CI 83% to 100%) with complete closure. Conclusions. Anterograde transcatheter closure using the new ADO is an effective therapy for patients with a PDA diameter up to 6 mm. Further clinical trials are underway. (J Am Coll Cardiol 1998;31:878–82) ©1998 by the American College of Cardiology The Rashkind, buttoned, Botalloocluder devices and coils have been used extensively for transcatheter closure of a patent ductus arteriosus (PDA) with variable degrees of successful deployment and an incidence of residual shunting varying between 3% and 38% (1–9). Furthermore, some of the devices require large delivery catheters, limiting their use in small infants, and the use of these devices and coils is technically challenging, especially for large PDAs. Recently, Sharafuddin et al. (10) reported on the use of a new self-expandable device (Amplatzer duct occluder [ADO]) to close surgically created aortopulmonary shunts in a canine model with very encouraging results. In the present report, we describe the immediate and short-term results using the ADO to close moderate- to large-sized PDAs. Methods Patients. From September 1996 to June 1997, 24 patients (18 female, 6 male) underwent attempted transcatheter closure of a PDA as an alternative to standard surgical ligation or the use of other devices. Informed consent was obtained from all patients. All patients had clinical and echocardiographic findings of a PDA. The patients median age was 3.8 years (range 0.4 to 48), and their weights ranged from 6 to 70 kg (median 15.5 kg). All patients were asymptomatic, except for Patient 22, who had failure to thrive and pulmonary artery hypertension (mean 46 mm Hg) from the large PDA (5.7 mm). All patients From the Department of Cardiology, Children University Hospital, Bratislava, Slovak Republic; *Department of Cardiology, Royal Liverpool Children Hospital, Liverpool, England, United Kingdom; †Department of Cardiology, Agia Children Hospital, Athens, Greece; ‡Department of Cardiology, Glenfield Children’s Hospital, Leicester, England, United Kingdom; §Division of Cardiology, Department of Pediatrics, University of Minnesota School of Medicine, Minneapolis, Minnesota; \Queen Alia Heart Institute, Amman, Jordan; ¶Division of Cardiology, Department of Pediatrics, Floating Hospital for Children at New England Medical Center, Tufts University School of Medicine, Boston, Massachusetts. Manuscript received June 26, 1997; revised manuscript received December 9, 1997, accepted December 22, 1997. Address for correspondence: Dr. Ziyad M. Hijazi, Division of Pediatric Cardiology, Department of Pediatrics, Tufts-New England Medical Center, Box 313, 750 Washington Street, Boston, Massachusetts 02111. E-mail: ziyad. This email address is being protected from spambots. You need JavaScript enabled to view it.. JACC Vol. 31, No. 4 March 15, 1998:878–82 878 ©1998 by the American College of Cardiology 0735-1097/98/$19.00 Published by Elsevier Science Inc. PII S0735-1097(98)00013-8 Downloaded from by on April 6, 2010 Abbreviations and Acronyms ADO - Amplatzer Duct Occluder CI - confidence interval PDA - patent ductus arteriosus Qp/Qs - pulmonary/systemic flow ratio had left atrial and ventricular volume overload documented by echocardiography and angiography. ADO device. The Amplatzer duct occluder (AGA Medical Corporation, Golden Valley, MN) is a self-expandable, mushroom-shaped device made from a 0.004-in. thick Nitinol wire mesh (a thin retention disk, 4 mm larger in size than the diameter of the device ensures secure positioning in the mouth of the PDA). The PDA is closed by the induction of thrombosis, which is accomplished by polyester fibers sewn securely into the device. Platinum marker bands are applied to the wire ends and laser welded. The shape is then formed by heat treatment. After cooling, a stainless steel sleeve with a female thread is welded to the marker band using advanced laser technology, Figure 1 demonstrates the device currently under clinical evaluation with the delivery system. All devices are cone-shaped and 7 mm in length, with a recessed screw, sizes are given from the larger to the smaller diameter. The delivery system consists of a delivery cable, long Mullins-type sheath,loader and pin vise (Fig. 1). Closure protocol. Figure 2 demonstrates the steps of the procedure for the implantation of the ADO. All patients underwent routine right and left heart catheterization using a 4F or 5F sheath in the femoral artery and a 6F sheath in the femoral vein. Heparin was used according to operator preferences. A biplane anteroposterior and lateral descending aortogram was performed to evaluate the size, position and shape of the ductus. A 5F or 6F multipurpose catheter was advanced from the venous side into the PDA and placed in the descending aorta. This catheter was exchanged for the delivery sheath (6F) over a 0.035-in. exchange guidewire and the dilator was removed, leaving the sheath in the descending aorta. The delivery cable was passed through the loader and the proper size occlusion device ($1 to 2 mm larger than the narrowest size of the PDA) was screwed clockwise into the tip of the delivery cable. The device and the loader were immersed in saline solution as the ADO was pulled into the loader. The loader was introduced into the delivery sheath and without rotation the device was advanced into the descending aorta. The sheath was retracted until the retention disk was opened in the proximal descending aorta. The sheath with the delivery cable in it were pulled back as one unit until the retention disk was snug against the aortic end of the ampulla. While maintaining tension on the delivery cable, the introducing sheath was withdrawn into the pulmonary artery to deploy the tubular frame of the prosthesis into the PDA, similar in a way to deployment of a self-expandable stent. With the device still attached to the cable, a descending aortogram was performed in the lateral projection to confirm device position. If there was device malposition, the device could be retracted back inside the delivery sheath. Once proper device position was confirmed, the device was released by turning the cable counterclockwise using the pin vise. A repeat descending aortogram Figure 1. Amplatzer Duct Occluder and delivery system. A, Schematic representation of the device. Note the cone shape and the various measurements; for example, for the 10-mm, 8-mm device, the distance between the two long curved arrows is 8 mm; the distance between the two short arrows is 10 mm; and the distance between the long straight arrow (retention disk) and the long curved arrow is always 7 mm for all devices. B, Closeup view of the device attached to the delivery cable by a microscrew. C, Entire delivery system with the device. Abbreviations and Acronyms ADO 5 Amplatzer Duct Occluder CI 5 confidence interval PDA 5 patent ductus arteriosus Qp/Qs 5 pulmonary/systemic flow ratio JACC Vol. 31, No. 4 MASURA ET AL. 879 March 15, 1998:878–82 NEW DEVICE FOR TRANSCATHETER CLOSURE OF PDA Downloaded from by on April 6, 2010 was performed 10 minutes after the release to assess the degree of residual shunt. Within 24 h, chest radiographs in the posteroanterior and lateral positions were obtained to assess device position, and each patient underwent a complete two-dimensional echocardiographic study and color flow mapping and Doppler interrogation using commercially available machines. At 1 and 3 months after closure, repeat echocardiography looking for residual ductal flow in the main pulmonary artery, left pulmo- Figure 2. Still frames in the lateral projection demonstrating the steps of closure technique using the ADO in a 1.3-year old, 7.5-kg infant (Patient 22). A, Descending aortic angiogram reveals a large PDA measuring 5.7 mm in diameter. B, The retention disk is opened in the proximal aorta, opposite the ampulla (arrow). C, The rest of the device is opened in the PDA. D, Repeat descending aortogram with the device still attached to the delivery cable, confirming a good position, with no obstruction to the aorta. E, Descending aortogram 10 min after release of the device, revealing a good device position with trace residual shunt. F, Descending aortogram 1 month after closure, revealing complete closure with good device position. 880 MASURA ET AL. JACC Vol. 31, No. 4 NEW DEVICE FOR TRANSCATHETER CLOSURE OF PDA March 15, 1998:878–82 Downloaded from by on April 6, 2010 nary artery stenosis or aortic obstruction was performed following previously described techniques (11,12). Chest X-ray films in posteroanterior projections were obtained to check for wire fractures during the same follow-up examinations. Statistical analysis. Results are expressed as mean value 6 SD or median and range; 95% confidence intervals were calculated for the 1- and 3-month follow-up periods. Results Patients. The clinical data of the 24 patients are shown in Table 1. The mean PDA diameter was 3.7 6 1.5 mm, and the median pulmonary/systemic flow ratio (Qp/Qs) was 2.2 (range 1.6 to 11). According to the classification adopted by Krichenko et al. (13), 22 patients had PDA type A, and 2 had type E. All closures were achieved from the venous side. In 23 patients the device was placed successfully in the PDA. One patient (Patient 7), a 9-kg infant with a PDA measuring 1.2 mm at its narrowest point with a short ampulla, initially underwent an attempt at deploying a device 6–4 mm in diameter and 10 mm in length. Deploying the retention disk in the aortic end resulted in obstruction of more than half the aorta. Therefore, the device was retracted inside the delivery sheath; placement of a coil resulted in complete closure. Subsequent to this patient, all devices were modified to make their length shorter (7 mm), and the screw was recessed inside the disk (Fig. 1). Eight patients had immediate angiographic closure of the PDA, including the single patient who received a coil; 14 patients had trace angiographic residual shunt (7) with “foaming” through the device and no contrast jet; and 2 patients had small residual shunt with a contrast jet through the device. One patient (Patient 22) with significant pulmonary artery hypertension (mean 46 mm Hg) had immediate improvement, with reduction of the pulmonary artery mean pressure to 24 mm Hg. The median fluoroscopy time was 13.5 min (range 6.3 to 47), and the median total procedure time was 60 min (range 36 to 185). The longest fluoroscopy and procedure times were in two patients (Patients 2 and 11). Patient 2 underwent the procedure during our early learning experience; in Patient 11, both the retention disk and the tubular part of the device were deployed inside the PDA, with some difficulty in repositioning the device precisely. There were no complications during or after the procedure. There was no evidence of obstruction of the left pulmonary artery or the descending aorta confirmed on the following day and on follow-up by Doppler interrogation. No patient required blood transfusion. There were no femoral arterial or venous complications. All patients were discharged home the day after the catheterization procedure. Discussion The feasibility of nonsurgical closure of the PDA was demonstrated when Porstmann et al. (14) in 1967 reported closing a PDA with an Ivalon plug in a 17-year old boy without thoracotomy. Subsequently, a number of devices and coils have been used for catheter closure of PDA with varying degrees of success (1–9). The major drawbacks of these devices and coils are the high incidence of residual shunt, the sometimes complex delivery systems and their unsuitability for larger PDAs. In this study, we report our initial human experience using a different new device to close PDAs #6 mm in diameter. We performed the closures from the venous side in all patients, using 6F catheters. The venous route has several advantages, including confirmation of PDA position before device release because the arterial catheter can be used for injection of contrast, avoidance of a large sheath in the femoral artery and the potential application of this technique to the very young infant who has PDA. Although we did not encounter all the angiographic types of PDA, we believe that such PDAs will be easily amenable to closure with this device. Further clinical testing is necessary to determine any potential size and angiographic shape limitations of this device. Although most patients had a residual shunt at the end of the procedure, none had a detectable residual shunt by color flow mapping within 24 h of implantation, stressing the advantage of the plug type of design of the device for closing PDAs. Although most procedures were performed under anesthesia and patients were admitted to the hospital for one night, we believe that because of the small size sheath, the closure can be safely performed as an outpatient procedure under local anesthesia and heavy sedation. On the basis of our preliminary work, the devices will be available in a kit that contains three different sizes (10–8, 8–6 and 6–4 mm) to cover the whole range of PDA sizes. Conclusions The ADO is safe and effective in closing PDAs in most patients with a PDA #6 mm in diameter. Further clinical trials are underway to assess any potential size or shape limitations before the widespread use of this device. References 1. Rashkind WJ, Mullins CE, Hellenbrand WE, Tait MA. Non-surgical closure of patent ductus arteriosus: clinical application of the Rashkind PDA occluder system. Circulation 1987;75:583–92. 2. Hosking MCK, Benson LN, Musewe N, Dyck JD, Freedom RM. Transcatheter occlusion of the persistently patent ductus arteriosus: forty-month follow-up and prevalence of residual shunting. Circulation 1991;84:2313–17. 3. Latson LA, Hofschire PJ, Kugler JD, Cheatham JP, Gumbiner CH, Danford DA. Transcatheter closure of patent ductus arteriosus in pediatric patients. J Pediatr 1989;115:549 –53. 4. Rao PS, Sideris EB, Haddad J, et al. Transcatheter occlusion of patent ductus arteriosus with adjustable buttoned device: initial clinical experience. Circulation 1993;88:1119 –26. 5. Verin VE, Saveliev VS, Kolody SM, Prokubovski VI. Results of transcatheter closure of the patent ductus arteriosus with the Botalloocluder. J Am Coll Cardiol 1993;22:1509 –14. 6. Moore JW, George L, Kirkpatrick SE, et al. Percutaneous closure of the small patent ductus arteriosus using occluding spring coils. J Am Coll Cardiol 1994;23:759–65. 7. Lloyd TR, Fedderly R, Mendelsohn AM, Sandhu SK, Beekman RH III. Transcatheter occlusion of patent ductus arteriosus with Gianturco coils. Circulation 1993;88:1412–20. 8. Hijazi ZM, Geggel RL. Results of anterograde transcatheter closure of patent ductus arteriosus using single or multiple Gianturco coils. Am J Cardiol 1994;74:925–29. 9. Hijazi ZM, Lloyd TR, Beekman RH III, Geggel RL. Transcatheter closure with single or multiple Gianturco coils of patent ductus arteriosus in infants weighing #8 kg: retrograde versus antegrade approach. Am Heart J 1996;132:827–35. 10. Sharafuddin MJ, Gu X, Titus JL, et al. Experimental evaluation of a new self-expanding patent ductus arteriosus occluder in a canine model. 11. Musewe NN, Benson LN, Smallhorn JF, Freedom RM: Two-dimensional echocardiographic and color flow Doppler evaluation of ductal occlusion with the Rashkind prosthesis. Circulation 1989;80:1706 –10. 12. Smallhorn JF, Huhta JC, Anderson RH, Macartney FJ: Suprasternal crosssectional echocardiography in assessment of patent ductus arteriosus. Br Heart J 1982;48:321–30. 13. 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. 14. Porstmann W, Wierny L, Warneke H: Closure of the persistent ductus arteriosus without thoracotomy. Ger Med Mon 1967;12:259–61. 882 MASURA ET AL. JACC Vol. 31, No. 4 Courtesy




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