Percutaneous Closure of Patent Ductus Arteriosus — Current Status

Since the description of successful surgical ligation of patent ductus arteriosus (PDA) by Gross and Hubbard in 1939,¹ surgery has been the procedure of choice in the treatment of PDA. Surgical treatment has been shown to be safe and effective with only occasional complications. However, investigators have been attempting to develop less invasive, transcatheter methods to occlude the PDA. The pioneering clinical investigations of Porstmann,² Rashkind,³ and their associates paved the way for the development of other transcatheter implantable devices for PDA closure. A number of PDA occluding devices have been designed and investigated and were reviewed elsewhere.^4,5 Most PDA devices were tested initially in animal models followed later by clinical trials in human subjects. Design, redesign, testing, retesting, and further refinement have occurred with most devices. The devices that were studied in animal models, but did not reach the stage of human clinical trials, are listed in Table 1 and will not be discussed further. The devices thus far described and used in human clinical trials are listed in Table 2. However, only a few of these devices have been approved for general clinical use by the approving authority in the US.

In this issue of the Journal, Peirone et al⁶ present results of PDA occlusion with Nit-Occlud PDA-R (NOPDA-R) device in 20 consecutive children referred to them for treatment of PDA. The NOPDA-R is a self-expandable, Nitinol-made, cone-shaped device with two distinctive features, namely, reverse reconfiguration of the distal (aortic) disc and a “snare-like” release mechanism. The device was implanted successfully in all 20 children without complications. Assessment by echocardiography with color Doppler revealed complete closure in 12 patients (60%) on the day following the procedure, but with higher closure rates of 90% (18 patients) and 95% (19 patients) at 1- and 3-month follow-up, respectively. The authors conclude that transcatheter PDA closure using the new NOPDA-R device is feasible, safe, and effective, and that a larger number of patients with a longer follow-up time are needed to assess long-term performance of this device. This is a well-written paper documenting the utility of the NOPDA-R device in closing PDAs, although the closure rates appear to be lower than what we observed in our experience with the Amplatzer duct occluder. However, testing of new devices is important so that there will be several “approved” devices that will become available to the practicing cardiologists who can select a device that is most appropriate for a given size and type of PDA.

I will review the “approved” and currently available PDA occlusion devices (Table 3) followed by device selection strategy and future directions.

Approved PDA Occlusion Devices

Gianturco coils. Gianturco coils are comprised of stainless-steel wire with thrombogenic Dacron fibers attached to them. These coils were originally described in 1975⁷ and were used to occlude renal arteries and have undergone some changes over the years. They are now commercially available for clinical use in a variety of wire diameters, helical decimeters, and lengths. They were initially used off-label, followed by FDA approval. Since the initial description by Cambier et al⁸ of successful closure of PDA, a number of modifications and refinements of the procedure have been undertaken and include antegrade and multiple coil techniques,⁹ snare-assisted coil delivery,¹⁰ bioptome-assisted coil delivery,11 temporary balloon occlusion of the ductus on the aortic¹² or pulmonary artery¹³ side, five loop coil design,^14,15 coil delivery via tapered tip catheters,^16,17 increasing the wire diameter to 0.052˝,^18,19 and coil implantation without the use of heparin.²⁰ Some of these techniques have advantages over the conventional retrograde coil delivery, whereas others may not improve upon the procedure. Many of these changes increase the complexity of the procedure, prolong the fluoroscopy and procedure time, or may increase the cost. These considerations should be taken into account when embarking on the use of modified techniques. My own preference is to utilize conventional retrograde delivery of free 0.038˝ Gianturco coils for very small PDAs.²¹

Detachable coils. Whereas Gianturco coils have been successfully used in occlusion of PDA, lack of controlled delivery and inability to retrieve and reposition the coil are thought to be potential problems. Therefore, detachable coils have been developed. Two different designs have been undertaken. The first type (Cook detachable coil) has a mechanism in which the notch of the stretched coil winding interlocks with the bead at the end of the core wire in the delivery catheter.²² Once the coil is positioned appropriately, the coil can be released by the handle at the proximal (outside the patient) end of the delivery catheter. The second design is also a Gianturco coil, but with an added short threaded extension at its proximal end. This is attached to the distal end of the delivery wire, which provides controlled delivery and retrieval when required. Following implantation at the desired location, the delivery wire is unscrewed from the coil, thus releasing the coil.²³ This is called “Flipper” detachable coil. Because the coil dislodgement and residual shunt rates are similar to those of free Gianturco coils, I prefer the simpler and cheaper conventional retrograde delivery of free 0.038˝ Gianturco coils for very small PDAs.²¹

Gianturco-Grifka vascular occlusion device (GGVOD). The GGVOD, consisting of a flexible nylon sac and a long occluding wire,^24,25 may have been a further modification of Megal’s nylon sac with a cross bar,²⁶ which was investigated in the late 1980s. The GGVOD is manufactured in 3, 5, 7, and 9 mm sizes, all of which can be deployed via 8 Fr sheaths. It is approved for general clinical use by the FDA. Because of the large delivery sheath required for implantation and difficulty in retrieval in case of device dislodgement, it is not frequently used in clinical practice.

Amplatzer ductal occluder (ADO). The ADO is constructed with 0.004˝-thick Nitinol wire mesh, mushroom in shape, and self-expandable in design.^27,28 The devices are 7-mm long (except the 5/4 device, which is 6-mm long); the aortic end is 2 mm larger than the pulmonary end. A thin retention disc is located on the aortic side, 4 mm larger than the aortic end of the device. A recessed screw is built into the pulmonary end for connection to the delivery wire. Polyester fibers are sewn into the device to induce thrombosis after implantation. The devices, depending on the size of the device, can be delivered via 6-8 Fr sheaths. Multiple sizes are available from the manufacturer. At the present time, this device appears to be the most commonly used device worldwide in the closure of moderate-to-large PDAs.

Summary of results of approved devices. The effectiveness of Gianturco coil occlusion is good^4,29 with all delivery techniques; residual shunts 24 hours after the procedure were present in 18% patients with free Gianturco coils, which decreased to 9% at follow-up. With detachable coils, residual shunts were present in 7-28% immediately after the procedure which decreased further at follow-up to 3-12%. Residual shunts were present in 9% of patients with GGVOD, all spontaneously closed during follow-up. Following implantation of the Amplatzer device, residual shunts were seen in 5-34%, which decreased to 0-3% at follow-up.²⁹ In a published multicenter US trial,³⁰ ADOs were successfully implanted in 435 of 439 patients (99%). Complete occlusion was demonstrated by angiography in 384 (76%) immediately postprocedure, which increased to 89% of patients by echocardiography the following day. At 1-year follow-up, 359 of 360 patients (99.7%) had complete closure. The complications are minimal, although coil/device embolization may occur, requiring transcatheter or occasionally surgical retrieval.^4,29

Device Selection Strategy

As alluded to in the preceding section, a number of transcatheter PDA occluding devices have been described, some of which have been utilized in clinical trials, as reviewed elsewhere.^4,5,29 However, no prospective, randomized clinical trials utilizing all eligible devices were reported to provide the cardiologist the information needed to decide on the best device for a given ductus. However, there are a few studies that compared two or three different devices as new devices became available; unfortunately, these are neither prospective nor randomized in their design and are not helpful in this regard. Feasibility, safety, and effectiveness are major considerations in the selection of a device for closure of PDA. The size of the delivery sheath, the ease with which the device is implanted, cost, and availability are other considerations. Based on experience with a number of devices and methods of closure, it appears that it is best to individualize decision based on the size (minimal ductal diameter) of PDA (Table 4) and perhaps the shape.³¹

Minimal ductal diameter. We do not advocate closure of the so-called silent ductus. Very small PDAs, less than 1.5 mm (Table 4) can be successfully closed using conventional 0.038˝ free Gianturco coils. The method is fairly simple and relatively inexpensive. Small PDA, i.e., between 1.5-3 mm, may also be closed with 0.038˝ Gianturco coils, but residual shunts are likely and may require multiple coils. We used to employ thicker, 0.052˝ coils, delivered retrograde via a 4 Fr long sheath with the assistance of a bioptome. We no longer use multiple coils or 0.052˝ coils; instead, we employ the Amplatzer duct occluder for these ducti. Moderate-to-large PDAs (>3 mm; Table 4) require devices and we now routinely employ the Amplatzer duct occluder; a device size at least 2 mm larger than minimal ductal diameter is usually selected. Certainly, conventional surgical closure³² and video-assisted thoracoscopic interruption of PDA³³ are the other available options.

Ductal shape. Earlier descriptions, such as conical, tubular, short, and long, have largely been replaced by a classification described by Krichencko et al.³¹ If the ductus is very small or small, the shape may not play an independent role in determining the feasibility or effectiveness of closure. However, if the ductus is moderate-to-large, the shape may have a special role in the feasibility and effectiveness of device closure. In the majority, Amplatzer duct occluder will be able to address the shapes. In long, tubular ductus, the Amplatzer vascular plug may a better choice.³⁴ If the ductus is very short, with aorto-pulmonary window-like appearance, atrial septal occluding devices may be used.

At this juncture, the selection of the method of closure of moderate-to-large PDA would largely depend upon the availability of a particular device or method of closure at a given institution at that particular time. Once several of the devices are approved for general clinical use, prospective randomized trials may provide data to objectively determine the best devices for PDA occlusion.

Future Directions

Availability of multiple approved new devices or modified (to improve performance) versions of old devices (such as that reported in this issue of the Journal) or others^35-37 may pave the way to prospective randomized trials, which I would recommend, although the likelihood of such a trial in the current circumstances is low. Devices to close PDAs in premature infants should be developed and some initial strides^38-42 for such methods/devices have occurred. Hypertensive PDAs may require special devices, such as muscular VSD occluder, although the major considerations are issues related to pulmonary vascular reactivity. Since the devices that we currently use are relatively new, long-term (10-20 year) follow-up studies are necessary to document long-term effectiveness and to demonstrate the absence of adverse events during late follow-up.

References  

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37. Thanopoulos BD, Tsaousis GS, Papadopoulos GS, et al. Transcatheter closure of patent ductus arteriosus using the swivel disk and plug occluders (abstr). Cathet Cardiovasc Interv. 2002;57:99.
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42. Bass JL, Wilson N. Transcatheter occlusion of the patent ductus arteriosus in infants — experimental testing of a new Amplatzer device. Catheter Cardiovasc Interv. 2011 Jan 13. [Epub ahead of print]

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From the University of Texas-Houston Medical School/Children’s Memorial Hermann Hospital, Houston, Texas.
Disclosure: The author has completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. The author reports no conflicts of interest regarding the content herein.
Address for correspondence: P. Syamasundar Rao, MD, Professor and Emeritus Chief, Division of Pediatric Cardiology, University of Texas/Houston Medical School, 6410 Fannin Street, UTPB Suite #425, Houston, TX 77030. Email: P.Syamasundar.Rao@uth.tmc.edu