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Initial experience of occluding special type patent ductus arterioses using the Amplatzer vascular plug

ZHANG, Po; ZHU, Xian-yang; WANG, Qi-guang; ZHANG, Duan-zhen; HAN, Xiu-min

doi: 10.3760/cma.j.issn.0366-6999.20123318
Original article
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Background Occluders licensed for clinical use are not fit for some special Krichenko E patent ductus arterioses. The Amplatzer vascular plug I (AVP1) has not been licensed for use for closure of patent ductus arteriose. We report our initial experience to occluding special type patent ductus arterioses with the AVP1-a single lobe device of single layer Nitinol mesh for short vessel landing zones.

Methods Patients referred with small and long Krichenko E patent ductus arterioses 1 mm to 3 mm in diameter underwent occlusion using AVP1. All cases underwent pre-, intra- and post-procedural echocardiography and chest X-ray at the completion of the procedure, the next day and at a 30-day, 3-month and 6-month follow-up visits. Device sizing for device waist diameter and length was based on aortography.

Results From April 2008 to June 2012, 26 patients with a mean age of (7.6±8.0) years (range 6 months-32 years) and a mean weight of (23.8±14.8) kg (range 7–67 kg) underwent successful patent ductus arteriose closure. The mean ductus diameter was (2.1±0.7) mm (range 1–3 mm). Transpulmonary (22/26) and transaortic approaches (4/26) were used. No persistent patency was observed after 24 hours and after one month. No device displacement, residual flow and iatrogenic coarctation of the aorta were observed after three months and six months.

Conclusions The AVP1 makes it easy to close some Krichenko E patent ductus arterioses. Smaller delivery catheter profile and symmetric cylindrical device shape allow for use for small and long Krichenko E patent ductus arterioses 1 mm to 3 mm in diameter and small patients through transaortic approaches. Broader experience is required to further delineate device and patient selection as well as to document its long-term efficacy and safety.

Department of Congenital Heart Disease, Cardiovascular Research Institute of People's Liberation Army General Hospital of Shenyang Military Command, Shenyang, Liaoning 110016, China (Zhang P, Zhu XY, Wang QG, Zhang DZ and Han XM)

Correspondence to: Dr. ZHU Xian-yang, Department of Congenital Heart Disease, General Hospital of Shenyang Military Command, No. 83, Wenhua Road, Shenhe District, Shenyang, Liaoning 110016, China (Tel & Fax: 86–24–28897420. Email: xyangz@yahoo.com.cn.) None of the contributing authors has a conflict of interest.

(Received December 23, 2012)

Edited by WANG Mou-yue and LIU Huan

Since the initial description by Porstmann et al1 of nonsurgical closure of patent ductus arteriosus (PDA), the percutaneous approach has developed into the standard clinical procedure. Currently devices that are designed and approved for closure of PDA in China are Cook coil and mushroom duct occluders.2–9 However, Gianturco and Flipper coils are the most commonly used coils in the USA for closure of small and medium size PDAs even though these coils were not originally designed for PDA occlusion.2 However, other devices are available for general vascular occlusion and have been adapted for use in closing the PDA.10,11 These include standard and detachable stainless steel coils12–14 and the Gianturco-Grifka vascular occlusion device.15,16 In spite of the range of devices and coils available for this procedure, there remains a limitation in some special type PDAs. Irrespective of the type of coil or device used, 12.7% of patients have the immediate residual shunts and some patients may need additional coils because of residual shunts.2

The recently released Amplatzer vascular plug I (AVP1) (AGA Medical Corp., USA) is designed to provide optimal embolization of peripheral veins and arteries, full cross sectional vessel coverage and controlled precise deployment.5,7,17 We report the novel use of this device for closure of small and long Krichenko E PDA 1 mm to 3 mm in diameter.

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METHODS

Study sample

Patients presenting with a clinically significant small and long Krichenko E 1 mm to 3 mm in diameter on admission at the Shenyang Command Military General Hospital in China, were referred for percutaneous closure with the AVP1. In instances where the PDA was larger than 3 mm in diameter, the use of the AVP1 device was not considered. Patients with additional cardiac anomalies requiring surgical correction were referred for surgery, while patients <5 kg in weight were also not considered. The protocols have been approved by the Ethics Committee for the conduct of our research.

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Device and delivery

As produced by AGA Medical Corporation, the AVP1 device is designed to provide optimal embolization of peripheral veins and arteries. It is a vascular occlusion device made of nitinol wire mesh shaped cylindrically by placement in the vessel (Figure 1). A small profile delivery catheter makes it easy to go through PDAs to complete occlusion whereas large profile, delivery catheters of other devices makes it difficult to pass through the PDAs.17,18 The sizing of the device is based on the diameter and length obtained by angiography. Diameter ranges are 4 mm to 16 mm and lengths are available in 7 mm or 8 mm (Figure 1). The device is symmetrically cylindrical, this allows for either transvenous or transaortic deployment. Devices with diameter of 4 mm to 8 mm can be delivered through a 4F (French) delivery system, while devices of 10 mm to 12 mm require a 5F system and the larger devices require a 6F system. The delivery system comprises a braided, flexible and tapered delivery sheath and a flexible delivery cable.

Figure 1.

Figure 1.

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Procedure

Devices were deployed using either transpulmonary or transaortic approaches. Briefly, the vascular AVP1 is supplied attached, loaded, to a 135 cm delivery cable. It only requires fluid flushing through a Y adaptor before inserting the plastic loader into the delivery sheath. Therefore, after transvenous transductal placement of a long sheath into the descending aorta, the device is advanced to the sheath tip. Only the distal end of the device is opened in the proximal descending aorta before withdrawing the entire delivery system into the PDA. The device was successfully placed within the PDA such that it was “dog-boned” in the middle to provide visual assurance of its stability. Device positioning is confirmed by aortography using a pigtail catheter positioned in the aorta. An alternative and more rapid approach is direct passage through the duct from the aorta, subsequent exposure of the pulmonary end, followed by deployment of the device. Aortographic contrast injections were performed through the delivery sheath to confirm device positioning. For PDAs of minimum size of <2 mm and length <8 mm, a 4-mm diameter device was used. For larger and longer PDAs, a device size of 2 mm to 8 mm greater than the minimal ductal diameter by angiography was used. In all cases, we performed transthoracic echocardiography prior to device release to confirm device position and ductal occlusion.

All patients were treated with preprocedural intravenous cefazolin (30 mg/kg) as well as an additional two doses postprocedurally within 24 hours. Intravenous heparin (50 U/kg) was administered at the commencement of each procedure. All patients underwent echocardiography at the completion of the procedure the next day and at a 30-day, three-month and six-month follow-up visit.

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RESULTS

From April 2008 to June 2012, 26 patients with appropriate PDAs were treated. The patient age range was 6 months to 32 years (mean age (7.6±8.0) years), with a weight range of 7 kg to 67 kg (mean weight (23.8±14.8) kg). The mean ductus diameter was (2.1±0.7) mm (range 1 mm to 3 mm). Ten adults were treated under local anaesthesia, with all remaining cases performed under general anaesthesia. All patients were asymptomatic.

Device deployment and intraprocedural ductal closure was successful in all cases. Next day echocardiography demonstrated ductal occlusion in all cases. At 30 days, echocardiography confirmed ductal occlusion without need for further intervention in any case. No recanalisation of PDAs was detected in any patient. No device displacement, residual flow and iatrogenic coarctation of the aorta were observed after three months and six months.

The device was deployed using a transvenous approach in 22 cases. In four cases, a transaortic approach was used (Figure 2). In one of the cases, a transvenous approach was attempted and the device was well positioned in the duct itself. At ten minutes, a small, silent, but significant, shunt was demonstrated by aortography and device positioning was fitting. However, at 20 minutes repeated aortography confirmed ductal occlusion without need for further intervention on that case (Figure 3).

Figure 3.

Figure 3.

Of the 26 cases, there was one case where the duct was very long; a 12 mm length of the device was deployed from the transpulmonary approach. The aortic terminal and pulmonary terminal were exposed in aorta and pulmonary artery. The devices were released with excellent acute results and no significant gradient around the device in the pulmonary artery and the aorta detected by echocardiography (Figure 4).

Figure 4.

Figure 4.

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DISCUSSION

We describe the novel use of a generalized vascular occlusion device, the Amplatzer vascular AVP1, for closing a special type of patent ductus arteriosus. Because the study involved small and long Krichenko E PDA 1 mm to 3 mm in diameter in these cases, several pitfalls were considered in the selection of an appropriate device. The length of the PDA would have made it difficult to position one coil easily and safely due to the possible displacement of the device.

Currently, the devices that are designed and approved for closure of PDA in China are the Cook coil and mushroom occluder. By comparison, the mushroom occluder, although effective in closing virtually all morphological types of PDAs, appears to have the most optimal positioning when used to close a Krichenko type A PDA, which is the most common type.2 Current guidelines suggest selecting a device whose smallest diameter is 1 mm to 2 mm larger than the smallest ductal diameter.19 In our case, this would have required a 4-mm duct occluder, which is 7-mm long in its uncompressed state, already shorter than the measured ductal length in our patients. The aortic retention disk is 8 mm in diameter, much larger than our patient's aortic ductal diameter of 2 mm to 4 mm. Given the ductal-aortic angle and the proportionately smaller aorta, the aortic retention disk would have protruded unacceptably into the aortic lumen, and pulmonary retention disk cannot be exposed in pulmonary lumen. In essence, a mushroom occluder with no retention disk seemed more appropriate and the vascular AVP1 most resembled such a design.

The vascular AVP1 was designed for optimal embolization of peripheral veins and arteries. The device is made of 144 gauge, nitinol wire. The main difference between the vascular AVP1 and the mushroom occluder is the absence of Dacron fibres in the former. In addition, it allows a smaller profile for delivery through small sheaths or guide catheters. The 144 gauge, nitinol allow for rapid ductal occlusion in the absence of integrated patches. This reduces residual shunt risks and the need to deploy additional coils or devices and results in extremely low profile device, delivery systems during deployment. Moreover, a symmetric, cylindrical device allows for special angle and shape of PDAs. In contrast, the mushroom duct occluder is made of 72 gauge nitinol and has fabric sewn to the inside. In our groups, 4F to 6F delivery catheter were often used.

Furthermore, the transaortic approach has significant benefits, allowing the procedure to be extremely simple and rapid with the use of a single arterial puncture (often 4F) and the capacity to perform test injections through the delivery sheath. This feature, although not exclusive to this device, certainly adds to its deployment flexibility. The AVP1 device provides a solution for the closure of small sized PDAs. The inherent prolongation significantly reduces the risk of anatomical distortion and displacement. The AVP1 can better fit small and long Krichenko E PDA 1 mm to 3 mm in diameter.

Several important issues arise from this initial experience resulting in extension and protrusion of the aortic end into the aorta. The first is the length and type of the ductal tissue and the inherent shape memory of nitinol. Current guidelines suggest selecting a device whose smallest diameter is 1 mm to 2 mm larger than the smallest ductal diameter. However, in our experience, the selection of devices does not only consider the smallest ductal diameter of pulmonary artery end, but also the length of PDAs, as well as the size and shape of the aortic ampulla. The appropriate sized vascular AVP1 is recommended to be 30% to 50% larger than the vessel diameter. Because of the distensibility of the ductal tissue and the inherent shape memory of nitinol, or a combination of both factors, we choose 100% to 300% larger diameter of PDA. When the length of PDA is >8 mm, the size of occluder should be 3 mm to 4 mm larger than the smallest ductal diameter. If the size of the ampulla of the aorta is >2 mm to 4 mm than the smallest ductal diameter at the end of the pulmonary artery, there should be an additional diameter of 1 mm to 2 mm added to the size of occluder at the base of the plug of 3 mm to 4 mm. When the length of PDAs and the size of aortic ampulla are larger, the diameter of device should be larger. A larger size occluder can assure successful intraprocedural ductal closure and avoid device displacement after the procedure.20 However, selection of larger occluders, may lead to protrusion in the aorta and or pulmonary artery. In this group, echocardiography could not detect redundant bulge and significant gradient around the device in the aortic and pulmonary artery.

The AVP1 makes it easy to close some Krichenko E PDAs and usage of this device maybe reduces costs due to trying different devices. Due to the range of anatomy and sizes that are treated, a single device will always be limited as a total solution. In extremely long and small ducts, the selection of device must not only take into account the smallest ductal diameter of pulmonary artery end, but also the length of PDAs, the size and shape of the aortic ampulla ostium. Broader experience is required to delineate further AVP1 device and patient matching, as well as to document its long-term efficacy and safety.

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Keywords:

patent ductus arteriosus; heart catheterization; intervention studies; therapeutic occlusion; Amplatzer vascular plug I

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