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 good4,29 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.
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 others35-37 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 strides38-42 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.
- Gross RE, Hubbard JP. Surgical ligation of patent ductus arteriosus: a report of first successful case. J Am Med Assoc. 1939;112:729-731.
- Porstmann W, Wierny L, Warnke H. Der Verschluss des Ductus Arteriosus persistens ohne Thorakotomie (1, Miffeilung). Thoraxchirurgie. 1967;15:109-203.
- Rashkind WJ, Cuaso CC. Transcatheter closure of patent ductus arteriosus: successful use in a 3.5-kg infant. Pediat Cardiol. 1979;1:3-7.
- Rao PS. Summary and comparison of patent ductus arteriosus closure devices. Current Intervent Cardiol Reports. 2001;3(3):268-274.
- Rao PS. History of transcatheter patent ductus arteriosus closure devices. In: Rao PS, Kern MJ, eds. Catheter Based Devices for the Treatment of Noncoronary Cardiovascular Disease in Adults and Children. Philadelphia, PA: Lippincott, Williams & Wilkins; 2003: pp. 145-153.
- Peirone A, Diaz J, Contreras A, et al. Percutaneous closure of the patent ductus arteriosus using the Nit-Occlud PDA-R (reverse) device: initial experience reporting immediate and short-term results. J Invasive Cardiol. 2011;23(12):513-516.
- Gianturco C, Anderson JH, Wallace S: Mechanical device for arterial occlusion. Am J Roentgenol Radium Ther Nucl Med. 1975;124(3):428-435.
- Cambier PA, Kirby WC, Wortham DC, et al. Percutaneous closure of small (<2.5 mm) patent ductus arteriosus using coil embolization. Am J Cardiol. 1992;69(8):815-816.
- Hijazi ZM, Geggel RL. Results of antegrade transcatheter closure of patent ductus arteriosus using single or multiple Gianturco coils. Am J Cardiol. 1994;74(9):925-929.
- Sommer RJ, Gutierrez A, Lai WW, Parness IA. Use of preformed nitinol snare to improve transcatheter coil delivery in occlusion of patent ductus arteriosus. Am J Cardiol. 1994;74(8):836-839.
- Hays MD, Hoyer NH, Glasow PF. New forceps delivery technique for coil occlusion of patent ductus arteriosus. Am J Cardiol. 1996;77(2):209-211.
- Berdjis F, Moore JW. Balloon occlusion delivery technique for closure of patent ductus arteriosus. Am Heart J. 1997;133(5):601-604.
- Dalvi B, Goyal V, Narula D, Kulkarni H, Ramakantan R. A new technique using temporary balloon occlusion for transcatheter closure of patent ductus arteriosus with Gianturco coils. Cathet Cardiovasc Diagn. 1997;41(1):51-62.
- Rao PS, Balfour IC, Chen S. Effectiveness of 5-loop coils to occlude patent ductus arteriosus. Am J Cardiol. 1997;80(11):1498-1501.
- Rao PS, Balfour IC, Jureidini SB, Singh GK, Chen SC. Five-loop coil occlusion of patent ductus arteriosus produces no recurrence of shunt at follow-up. Cathet Cardiovasc Interv. 2000;50(2):202-206.
- Kuhn MA, Latson LA. Transcatheter embolization coil closure of patent ductus arteriosus — modified delivery for enhanced control during coil positioning. Cathet Cardiovasc Diagn. 1995;36(3):288-290.
- Prieto LR, Latson LA, Dalvi B, Arbetman MM, Ebeid MR, Lamorgese TT. Transcatheter coil embolization of abnormal vascular connections using a new type of delivery catheter for enhanced control. Am J Cardiol. 1999;83(6):981-983.
- Owada CY, Teitel DF, Moore P. Evaluation of Gianturco coils for closure of large (>3.5 mm) patent ductus arteriosus. J Am Coll Cardiol. 1997:30(7):1859-1862.
- Grifka RG, Jones TK. Transcatheter closure of large PDA using 0.052˝ Gianturco coils: controlled delivery using a bioptome catheter through a 4 French sheath. Cathet Cardiovasc Interv. 2000;49(3):301-306.
- Liang CD, Wu CJ, Fang CY, Ko SF, Wu YT. Retrograde transcatheter occlusion of patent ductus arteriosus and preliminary experience in Gianturco coil technique without heparinization. J Invasive Cardiol. 2000;13(1):31-35.
- Rao PS. Coil occlusion of patent ductus arteriosus (editorial). J Invasive Cardiol. 2000;13(1):36-38.
- Cambier PA, Stajduhar KC, Powell D, et al. Improved safety of transcatheter vascular occlusion utilizing a new retrievable coil device. J Am Coll Cardiol. 1994;23:359A.
- Uzun O, Hancock S, Parsons JM, Dickinson DF, Gibbs JL. Transcatheter occlusion of the arterial duct with Cook detachable coils: early experience. Heart. 1996;176(3):269-273.
- Grifka RG, Vincent JA, Nihill MR, Ing FF, Mullins CE. Transcatheter patent ductus arteriosus closure in an infant using Gianturco-Grifka device. Am J Cardiol. 1996;78(6):721-723.
- Grifka RG. Transcatheter PDA closure using the Gianturco-Grifka vascular occlusion device. Current Intervent Cardiol Rep. 2001;3(2):174-181.
- Magal C, Wright KC, Duprat G Jr, Wallace S, Gianturco C. A new device for transcatheter closure of patent ductus arteriosus: a feasibility study in dogs. Invest Radiol. 1989;24(4):272-276.
- Sharafuddin MJA, Gu X, Titus JL, et al. Experimental evaluation of a new self-expanding patent ductus arteriosus occluder in a canine model. J Vasc Intervent Radiol. 1996;7(6):877-887.
- Masura J, Walsh KP, Thanopoulos B, et al. Catheter closure of moderate-to-large-sized patent ductus arteriosus using new Amplatzer duct occluder: immediate and short-term results. J Am Coll Cardiol. 1998;31(4):1878-1882.
- Rao PS. Summary and comparison of patent ductus arteriosus closure methods. In: Rao PS, Kern MJ, eds. Catheter Based Devices for the Treatment of Noncoronary Cardiovascular Disease in Adults and Children. Philadelphia, PA: Lippincott, Williams & Wilkins; 2003: pp. 219-228.
- Pass RH, Hijazi Z, Hsu DT, Lewis V, Hellenbrand WE. Multicenter USA Amplatzer patent ductus arteriosus occlusion device trial: initial and one-year results. J Am Coll Cardiol. 2004;44(3):513-519.
- Krichencko A, Benson LN, Burrows P, Moes CA, McLaughlin P, Freedom RM. Angiographic classification of the isolated, persistently patent ductus arteriosus and implications for percutaneous catheter occlusion. Am J Cardiol. 1989;90(12):2525-2529.
- Mavroudis C, Becker CL, Gewitz M. Forty-six years of patent ductus arteriosus division at Children’s Memorial Hospital of Chicago: standards for comparison. Ann Surg. 1994;220(3):402-410.
- Laborde F, Noihomme P, Karam J, et al. A new video-assisted thoracoscopic surgical technique for interruption of patent ductus arteriosus in infants and children. J Thorac Cardiovasc Surg. 1993;105(2):278-280.
- Tsounias E. Rao PS. Versatility of Amplatzer Vascular Plug in occlusion of different types of vascular channels. Catheter Cardiovasc Interv. 2008;71(7).
- Ewert P, Kretschmar O, Nuernberg JH, Nagdyman N, Lange PE. First closure of a large patent ductus arteriosus in an infant with angulated nitinol plug. Cathet Cardiovasc Intervent. 2002;57(1):88-91.
- Masura J, Gavora P, Podnar T. Transcatheter occlusion of patent ductus arteriosus using a new angled Amplatzer duct occluder: initial clinical experience. Catheter Cardiovasc Interv. 2003;58(2):261-267.
- 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.
- Haneda N, Masue M, Tasaka M, Fukui C, Saito K, Yamaguchi S. Transcatheter closure of patent ductus arteriosus in an infant weighing 1180 g. Pediatr Int. 2001;43(2):176-178.
- Thukaram R, Suarez WA, Sundararaghavan S. Transcatheter closure of the patent arterial duct using the Flipper coil in a premature infant weighing 1400 g: a case report. Catheter Cardiovasc Interv. 2005;66(1):18-20.
- Roberts P, Adwani S, Archer N, Wilson N. Catheter closure of the arterial duct in preterm infants. Arch Dis Child Fetal Neonatal. 2007;92(4):248-250.
- Francis E, Singhi AK, Lakshmivenkateshaiah S, Kumar RK. Transcatheter occlusion of patent ductus arteriosus in pre-term infants. JACC Cardiovasc Interv. 2010;3(5):550-555.
- 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]
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: [email protected]