Initial Experience with the New Amplatzer® Duct Occluder II

ABSTRACT: Background. Different devices are used for trans-catheter occlusion of patent ductus arteriosus (PDA), each with its own limitations and complications. We report our initial single-center experience with the new Amplatzer® Duct Occluder II (ADO II), which has been designed to address some of these issues. Methods. From April until October 2008, 10 consecutive patients with PDA (minimal diameter ≥ 2 mm) were enrolled for intention-to-treat with ADO II. The median age was 10.2 years (7 months to 51.4 years); the median weight was 35.5 kg (6.3–70 kg). Results. ADO II implantation was attempted in 10/10 patients. The mean PDA diameter was 3.1 mm (± 1.0 mm), and the mean device waist diameter was 4.0 mm (± 1.3 mm). In 1 patient, the ADO II encroached upon the left pulmonary artery, hence it was changed to an Amplatzer Duct Occluder I. In another patient, the shape and size of the duct necessitated the use of a Cook detachable coil. Complete angiographic closure was achieved in 8/8 ADO II implantations (100%) and in the patient with the coil. In the patient with an ADO I, complete echocardiographic closure was demonstrated at 24 hours. No device embolization or complications related to implantation occurred. Conclusions. This initial experience demonstrates the feasibility and efficacy of the ADO II to occlude PDA with a minimum diameter ≥ 2 mm. It is especially useful in smaller children with larger duct diameters. Longer-term follow up in a larger cohort of patients is required to establish safety and long-term results. Key Words: Amplatzer Duct Occluder II, patent ductus arteriosus J INVASIVE CARDIOL 2009;21:401–405 A patent ductus arteriosus (PDA) is one of the most common lesions in congenital cardiology.1 Since the middle ages, Leonardo Botallo’s name has normally been associated with the first description of a PDA.2 The strategies for management of PDAs continue to evolve. In 1939, Gross and Hubbard described the first successful surgical closure of a patent arterial duct.3 Porstmann and colleagues reported the first transcatheter closure of a PDA in 1967,4 and in 1979, Rashkind and colleagues performed the successful deployment of a percutaneously delivered double-disk device in an infant.5 Since then, transcatheter occlusion of PDAs has been a well-established alternative to surgical closure6–10 and various devices and coils have been used to occlude the PDA. The Amplatzer® Duct Occluder I (ADO I) (AGA Medical Corp., Golden Valley, Minnesota) was introduced in 1999, and since then numerous studies have been published, proving its safety and efficacy as a device for transcatheter PDA occlusion.11–13 Due to the limitations in terms of PDA shape and size amenable to transcatheter occlusion, minimum weight of the patient, size of the delivery sheath/system and associated complications, further modifications of the ADO I were introduced, viz. the angled Amplatzer duct occluder, the swivel-disc device and the plug occluder, but these failed to address all the concerns. The Amplatzer Duct Occluder II (ADO II) was introduced earlier this year to address some of these limitations. We present our single-center experience with this new ADO II in cases of transcatheter occlusion of a persistent arterial duct in patients weighing ≥ 5 kg. Methods From April 2008 until October 2008, 10 consecutive patients with a PDA with a minimal diameter of ≥ 2 mm were enrolled for intention-to-treat with an ADO II. The median age was 10.2 years (range 7 months–51.4 years). The median weight was 35.5 kg (range 6.3–70 kg). Informed consent was obtained from parents of minors and from adult patients. Relevant approvals were obtained from the hospital authorities, and we conformed to our institutional guidelines and those of the American Physiological Society. The procedure was performed under general anesthesia and fluoroscopy. Preprocedural assessment included clinical examination, two-dimensional (2-D) echocardiography (Phillips® ie33 and Phillips® SONOS 7500; Philips Healthcare, Andover, Massachusetts), chest X-ray and 12-lead electrocardiography (ECG). Inclusion criteria. All consecutive patients who had clinical and/or echocardiographic evidence of a moderate-to-large PDA and weighed ≥ 5 kg were enrolled with an intention-to-close the PDA with an ADO II. The decision to deploy an ADO II was based on the PDA size and morphology as seen on angiography. Patients were excluded if they had evidence of pulmonary hypertension, weight 6 kg and > 6 months in age. The Amplatzer Duct Occluder II can treat all types of PDAs in the Krichenko Classification14 from 5.5 mm to 12 mm in length and > 5.5 mm in diameter on angiography. The device has a screw attachment for a delivery wire and radiopaque markers. The recommended sizes for the low-profile TorqVue® LP (AGA Medical) braided and tapering delivery sheath are 4 Fr and 5 Fr. It has a flexible distal catheter segment that allows for easy approachability. The wire for device positioning and deployment is braided with a flexible nitinol tip. The device can be deployed, recaptured and redeployed for precise and secure placement. Procedure. Access was obtained in the usual way in the groin vessels. Periprocedural antibiotics were given according to the protocol. A descending aortogram in the lateral projection was recorded with a 4 or 5 Fr pigtail catheter to define the morphology and size of the duct. Subsequently, a 4 or 5 Fr multipurpose catheter was advanced from the venous side through the PDA into the descending aorta. A standard 150 cm (0.0035 inch) guidewire was used to exchange the multipurpose catheter for either a 4 or a 5 Fr TorqVue LP delivery sheath that was advanced from the femoral vein into the descending aorta. An ADO II 1–2 mm larger than the narrowest waist of the duct was chosen. We chose a 4 mm-long device for PDAs ≤ 5 mm long, and a 6 mm length device for PDAs ≥ 5 mm long. Pulmonary pressures were ascertained. The device was introduced into the delivery sheath and advanced under fluoroscopic guidance into the descending aorta, where the retention disc was deployed. Then, the sheath and the delivery cable were pulled back until the retention disc was against the aortic end of the ampulla or in the ampulla. While gentle tension was maintained on the delivery cable, the introducer sheath was withdrawn into the pulmonary artery to deploy the waist of the ADO II, and then the second disc was deployed at the pulmonary end of the PDA. With the device still attached to the cable, a descending aortogram was recorded in the lateral projection to confirm the device’s position. Once proper device position was confirmed, the device was released by anticlockwise rotation of the delivery cable. A repeat descending aortogram was recorded 10 minutes after the release to check for residual shunts. All patients were discharged 24 hours after the procedure and given no medication. Clinical examination, 12-lead ECG, chest X-ray and echocardiography were performed in all patients prior to discharge. Statistical analysis. All results are expressed as either mean ± standard deviation or median (range). Results The PDA types and the devices used are shown in Table 1. The smallest minimum ductal diameter was 2.1 mm and the largest was 5.1 mm. The ADO II was placed in 10/10 patients with intention-to-treat (Table 1). The transvenous approach was used in all patients. In patient no. 8, the angiographic PDA size was 5.1 mm and the length was 8 mm. A 6 x 4 mm ADO II was placed, but the waist and the right disc did not conform properly. Hence, it was retrieved back into the sheath and was replaced with a 5 x 4 mm ADO II device, which was successfully placed and deployed with optimum results. A 6 x 4 mm ADO II was positioned in patient no. 9, however, the right disc caused partial but significant obstruction of flow to the left pulmonary artery and was protruding into the pulmonary artery more than was deemed safe to leave it in that position. There was a significant risk of device displacement as well, thus, the device was removed and substituted with a 5 x 4 mm ADO I. This patient had a trivial residual shunt immediately afterwards, but echocardiography 24 hours later showed complete resolution of the shunt. In patient no. 10, the PDA size was 2.5 mm on transthoracic echocardiography. On angiography, the size was 2.3 mm, and it was a Type E PDA. A 3 x 4 mm ADO II was deployed, but the waist was seen to be compressed by the PDA, leading to significant protrusion of the right disc and the right articulation in the pulmonary artery, necessitating the use of a 3 x 4 mm Cook MReye Flipper detachable coil (Cook, Inc., Bloomington, Indiana). There were no procedural complications in any of these patients. Of the 10 patients, 9 had on-table complete occlusion, while 1 had trivial intraprosthetic residual shunt immediately after the procedure. All patients were discharged home the day after the procedure. Clinical examination revealed absence of the murmur, 12-lead ECG was unremarkable and the chest X-ray showed the devices to be in optimal position. There was no evidence of hemolysis on urine analysis. Two-dimensional and color Doppler echocardiography did not reveal any pericardial effusion. The devices were in place with no residual shunts, and there were no obstructions of the descending aorta or the pulmonary artery. Complications. There was no device embolization, no major or minor complications occurred and there were no deaths. Discussion Outside the “premature-baby” age group, isolated PDA closure is indicated in the setting of heart failure, failure to thrive and for prevention of infective endocarditis. The management of PDAs has come a long way since the first transcatheter occlusion by Porstmann.4 It is continually evolving, and in the current era, percutaneous PDA closure is well established, utilizing a number of coils and devices.6–9,11,12 Surgical closure is usually reserved for premature babies, smaller infants and children with relatively larger ducts, and for adults in whom the ducts are too large to close percutaneously.15–17 The initial devices and coils had major drawbacks in the form of a high incidence of residual shunting, complex delivery systems and large delivery sheaths and their unsuitability for large PDAs or small children.18 The introduction of the ADO I addressed some of these issues. Masura et al11 and Faella and Hijazi12 reported their results with the use of the ADO I. In the past, we have also reported our results with the ADO I both in young symptomatic children and adults, with a success rate of up to 100% and a very low complication rate.19,20 In our experience, percutaneous PDA closure in young symptomatic patients is safe, but poses a slightly higher risk than in older patients. There is always the concern of using larger sheaths and delivery systems in smaller children, especially those with bigger PDAs. Bilkis et al13 reported on a large series of 205 patients with a PDA occluded using the ADO I. Closure was successful in all patients. Complications occurred in 3% and included device embolization, significant blood loss and aortic narrowing. Pass et al21 presented the initial and 1-year results from the multicenter Amplatzer PDA occlusion device trial. The ADO I was implanted successfully in 99% of patients, and the latest follow up demonstrated a closure rate of 98%. Complications were seen in 7% and included death, device embolization requiring surgery, partial obstruction of the left pulmonary artery, pseudo-aneurysm formation, significant bleeding, loss of femoral pulse, arrhythmias and groin hematomas. To address some of these issues in relation to the ADO I, viz. device embolization, size of the delivery sheath, conformity to the anatomy of the duct, residual shunting and implantation in smaller infants, AGA Medical introduced the ADO II. All the available ADO II devices can be delivered through a relatively small 4 or 5 Fr delivery system and can thus be used with greater safety in smaller infants with less risk of vascular complications. In our series, we used a relatively large device (6 mm) in a small infant weighing 6.3 kg with a large 5.1 mm PDA with good results. The use of relatively small sheaths and the ability to deploy from either the aortic or the pulmonary side simplifies the procedure. In particular, in larger children and adults, there may be no need for general anesthesia for a procedure that can be accomplished in less than 15 minutes without any pain or discomfort for the patient. In our series, according to our unit’s policy, we performed all the procedures under general anesthesia or deep sedation. Multilayered mesh lobes create six planes of occlusion with full cross-sectional coverage for complete closure. In this series, 90% of patients had complete on-table closure and 100% had complete closure at 24-hour follow up. We closed all types of PDA with this device (Types A–E) in varying age groups. The minimum and maximum waist sizes of the PDA closed were 2.1 and 5.1 mm, respectively. Our small series shows that the initial experience with this new device is encouraging. There were no major or minor complications. Patient selection and careful assessment of the ductal anatomy will reduce the incidence of nonimplantation of the device. Study limitations. This was an initial study in “all-comers” with a PDA ≥ 2.0 mm and weighing ≥ 5 kg. Our main limitation was the small number of patients in this series. Long-term follow up is required to assess late complications including device embolization and encroachment on the aorta and the pulmonary arteries. Also, more clinical experience is needed with smaller infants with larger PDAs to assess any potential limitation related to the use of this device in this subgroup of patients for whom this appears to be an attractive option. Conclusion Our initial experience with the new Amplatzer Duct Occluder II shows that it is feasible and effective in providing rapid occlusion of PDAs with a diameter ≥ 2.0 mm and varying morphology. The device design allows for deployment from both the arterial and venous sides and confers a greater degree of interventional flexibility. This is especially useful in smaller children with larger duct diameters. With judicious selection of patients based on ductal size and shape, correct positioning of the discs, embolization of the device and obstruction of the descending aorta and pulmonary artery can be minimized. Longer follow up and a larger cohort of patients are necessary to precisely define the efficacy, safety and appropriate indications for this device. From the IRCCS Policlinico San Donato, Milan, Italy. The authors report no conflicts of interest regarding the content herein. Manuscript submitted December 30, 2008, provisional acceptance given February 19, 2009, final version accepted April 7, 2009. Address for correspondence: Jaspal S. Dua, MD, MRCPCH, DCH, IRCCS Policlinico San Donato, Department of Paediatric Cardiology and Adult with Congenital Heart Defeca, via Morandi 30, San Donato Milanese, Milan 20097 Italy. E-mail: jaspaldua@yahoo.com

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