Cardiac Catheterization and Imaging (From Pediatrics to Geriatrics) IB Vijayalakshmi
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SECTION 1
1History and Basics of Catheterization
  • History of Transcatheter Interventions in Pediatric Cardiology
  • History of Transcatheter Interventions in Adult Cardiology
  • Radiation Safety and Contrast Agents
  • Preparation for Cardiac Catheterization
  • Percutaneous Vascular Access for Cardiac Catheterization
  • Hardware in Catheterization Laboratory
2

History of Transcatheter Interventions in Pediatric Cardiology1

P Syamasundar Rao
  • • Balloon Angioplasty/Valvuloplasty
  • • Transcatheter Occlusion of Cardiac Defects
  • • Catheter-based Atrial Septostomy
  • • Endovascular Stents
  • • Other Transcatheter Interventions
 
INTRODUCTION
Corrective or palliative surgery has been the usual treatment of congenital heart defects (CHDs) in children. But, over the last three and a half decades, a number of percutaneous, transcatheter methods were developed to manage the cardiac defects. While transcatheter method of treatment of CHDs started in early 1950s,1,2 it was not until mid/late-1980s that a more frequent use of transcatheter methods in children was achievable, save balloon atrial septostomy which has been in practice since 1966.3
To the best of my knowledge, Rubio-Alvarez et al.1 in 1953 were the first to perform pulmonary valvotomy; they used a ureteral catheter/wire assembly to cut the fused pulmonary valve commissures with resultant pulmonary valvotomy. This was performed to imitate closed pulmonary valvotomy described by Brock.4 Peak-to-peak pulmonary valve gradient decreased from 72 mm Hg to 59 mm Hg following the procedure in a 10-month-old baby. To my knowledge, this is the first attempt to treat CHD by a transcatheter technique. The following year they applied a similar procedure in another patient with pulmonary valve stenosis and in several patients with tricuspid valve stenosis and reported significant improvement in clinical status of these patients.2 No additional publications of this method either by these or others investigators appeared in the literature.
A decade later (in 1964), Dotter and Judkins5 performed dilatation of stenotic lesions of peripheral arteries by passage of guide wires across narrowed lesions followed by passage of progressively increasing sizes of dilating catheters. Immediate and follow-up results were reported to be excellent. Shortly thereafter, Rashkind and Miller described balloon atrial septostomy3 and Porstmann and his associates reported transcatheter occlusion of patent ductus arteriosus (PDA).6 In this chapter, the author will review historical aspects of transcatheter treatment of heart disease in children. Historical priority assignment is largely based on publications verifiable to the satisfaction of the author of this Chapter.
 
BALLOON ANGIOPLASTY/VALVULOPLASTY
As alluded to in the preceding section, Rubio-Alvarez and Limon-Lason1,2 described the use of customized ureteral catheters in relieving pulmonary and tricuspid valve stenoses in early 1950s. In the following decade, Dotter and Judkins5 employed a gradational dilatation procedure to open up peripheral arterial stenotic lesions. In mid-to-late 1970s, Grüntzig and his associates7 modified the idea of Dotter and Judkins by developing a double-lumen catheter with a nonelastic balloon, which was effectively utilized to enlarge obstructive lesions of the peripheral (iliac, femoral, popliteal),8 renal9 and coronary10,11 arteries. The utility of balloon dilatation concept was subsequently extended to enlarged stenotic lesions of the aorta,12 pulmonary valve,13 aortic valve,14 mitral valve15 and other stenotic lesions.16,17
 
Pulmonary Stenosis
As mentioned above, the initial attempts to relieve pulmonary valve stenosis by a transcatheter method was in the early 1950s by Rubio-Alvarez et al.1,2 They used ureteral catheters with a wire to incise the stenotic pulmonary valve. Subsequently in 1979, Semb and his colleagues18 used a different method to relieve pulmonary valve obstruction; this is by rapidly withdrawing an inflated Berman angiographic catheter across a stenotic pulmonary valve. But, use of this technique was not reported by any other investigator. In 1982, Kan et al.13 adopted the technique of Grüntzig and associates7–11 4to produce relief of pulmonary valve stenosis; they utilized radial forces of balloon inflation of a catheter placed across the pulmonary valve. This type of balloon dilatation technique is presently in use at all institutions around the world to relieve pulmonary valvar stenosis.
The concept to use balloons larger than pulmonary valve annulus to produce successful balloon pulmonary valvuloplasty with a balloon-to-annulus ratio of 1.2:1.4 was developed in mid-1980s; this is based on the immediate19 and both immediate and follow-up20–22 results. Balloon-to-annulus ratio of 1.2:1.4 was used for the next decade or so. However, because of reports of development of significant pulmonary insufficiency, some requiring pulmonary valve replacement, with the use of large noncompliant balloons,23 we have recommended revision of balloon-to-annulus ratio to 1.2:1.25.24–26
Tynan et al. were the first to extend the technique of balloon pulmonary valvuloplasty to address treatment of critical pulmonary stenosis in the neonate.27
Our group was among the first to study causes of restenosis after balloon pulmonary valvuloplasty;28 two risk factors for renarrowing were recognized: Balloon-to-pulmonary valve annulus ratio less than 1.2 and immediate postvalvuloplasty peak-to-peak pulmonary valve gradient in excess of 30 mm Hg. Such risk factors for recurrence were later confirmed by a large multi-institutional study.29 We were also among the first to point out that pulmonary insufficiency is likely to be a problem during late follow-up after balloon pulmonary valvuloplasty30 and that we should be watchful to monitor for progressive pulmonary insufficiency during long-term follow-up.
 
Aortic Stenosis
Subsequent to successful use of Grüntzig's balloon angioplasty technique7–11 to aortic coarctation12,31,32 and pulmonary valve stenosis,13 Lababidi and his associates14,33 extended the technique to aortic valvar stenosis. Lababidi was also the first investigator to extend the technique to the neonate with critical aortic valve stenosis.34 Although femoral arterial approach was the most common approach to perform balloon aortic valvuloplasty, several investigators used carotid artery,35 umbilical artery,36 femoral vein,37,38 subscapular artery39 and umbilical vein40 in order to avoid injury to the femoral artery, particularly in the neonate.
We were among the first to examine the causes of restenosis of aortic valve obstruction following balloon aortic valvuloplasty41 and determined that age less than 3 years and immediate postballoon aortic valve peak-to-peak gradient greater than 30 mm Hg are predictors of recurrence and recommended that avoidance or reduction of risk factors may help decrease recurrence following balloon dilatation. We have also tried to explore the causes of aortic insufficiency during long-term follow-up subsequent to balloon aortic valvuloplasty.42
 
Fixed Subaortic Stenosis
Balloon angioplasty to treat fixed subaortic membranous stenosis was first reported by Suárez de Lezo et al.43 in 1986. Subsequent studies by Lababidi,44 Shrivastava45 and their colleagues indicated that the results are best when the thickness of the subaortic membrane is less than 2 mm. Suárez de Lezo46 identified subaortic membrane thinner than 2.5 mm and age more than or equal to 13 years are predictors of good long-term outcome.
 
Native Aortic Coarctation
Balloon angioplasty technique of Grüntzig was applied to dilate coarcted aortic segments in a postmortem specimen by Sos et al.12 in 1979 demonstrating that it is possible to enlarge the coarcted aortic segments. Shortly thereafter, Singer et al.31 used the technique to relieve obstruction caused by postoperative aortic recoarctation in 1982. But, Sperling and his colleagues32 in 1983 were the first who performed balloon angioplasty of native aortic coarctation.
As reported by Valvuloplasty and Angioplasty of Congenital Anomalies (VACA) Registry, several other cardiologists used this technique in a large number of patients to treat both native aortic coarctation47 and postsurgical recoarctation.48 While the degree of relief of obstruction and complication and death rates were similar,49 the Registry investigators47,48 concluded that “the question remains not can it be done, but should it be done?” for native coarctation47 and “… balloon angioplasty for relief of residual or recurrent aortic coarctation offers an acceptable alternative to repeat surgical repair” for postsurgical recoarctation.48 Such flawed interpretation was questioned49 affirming that “this is not logical and that objectivity of scientific interpretation should be maintained”. Afterwards, additional arguments were presented50–52 supporting balloon angioplasty as a first-line treatment option in the management of native aortic coarctation. Later, a large number of other institutions adopted balloon angioplasty of aortic coarctation, as reviewed elsewhere.53 Causes of recoarctation following balloon angioplasty54 aortic remodeling after balloon angioplasty,55,56 and biophysical response of coarcted aortic segment to balloon dilatation57 were studied subsequently.
 
Postsurgical Aortic Recoarctation
Following the adaptation by Sos and colleagues12 of Grüntzig's technique of balloon angioplasty to expand postmortem coarcted aortic segments in 1979, Singer and his associates31 5used the balloon angioplasty to improve postoperative aortic recoarctation in 1982. Subsequently, a large number of investigators adopted this technique as reported by VACA Registry48 and well as by our group.58 Long-term results59 were also documented. At this time, balloon angioplasty is preferred treatment for postsurgical aortic recoarctations.
 
Branch Pulmonary Artery Stenosis
Balloon angioplasty of branch pulmonary artery stenosis was first reported by Martin and his associates;16 they performed this procedure in an 18-year-old patient who was found to have bilateral branch pulmonary stenosis after tetralogy of Fallot surgery. They demonstrated immediate angiographic improvement. Sometime thereafter, Lock et al.60 reported their experience in which they were able to perform balloon angioplasty of pulmonary arteries in five of the seven children in whom they attempted the procedure. The gradient across the obstruction diminished; the diameter of the stenosed segment increased and the quantitative pulmonary perfusion to the ipsilateral lung improved. Several other institutions also used this procedure, reported by the VACA Registry.61 Despite improvement in vessel dimension and pressure gradient, there was little fall in proximal pressures. Subsequent analysis by the same group of investigators62 indicated that in the best of hands and with a suitable technique, success rate was about 50% and complication rate was high. High pressure balloon angioplasty was then tried;63 in spite of initial enthusiasm, this modified technique did not seem to produce superior results. Most interventionalists believe that intravascular stents may be better in the management of branch pulmonary artery stenosis.
 
Mitral Stenosis
Balloon mitral valvotomy for rheumatic mitral stenosis was first reported by Inoue and his colleagues in 1984.15 A especially designed balloon with reinforced nylon micromesh was used. The size and shape of the balloon change depending on the amount of diluted contrast material injected into the balloon. They performed the procedure successfully in five of the six rheumatic mitral stenosis patients in whom it was attempted with resultant reduction in the mean diastolic pressure gradient across the mitral valve. There afterwards, regular single64 and double65 balloons were used, producing essentially similar outcome. Ensuing experience, however, indicated that the Inoue balloon may be better, especially because the cardiologist is able to gradually increase the balloon size, until an optimal result is produced. The Inoue balloon appears to be the most common method utilized in countries where rheumatic mitral stenosis is common.
 
Cyanotic Heart Defects with Pulmonary Oligemia
Following the report of successful results of balloon valvuloplasty for isolated pulmonary valve stenosis by Kan and her associates,14 we66,67 were among the first to apply balloon pulmonary valvuloplasty to increase pulmonary blood flow in place of systemic-to-pulmonary artery shunt. We were able to successfully improve pulmonary oligemia and systemic arterial hypoxemia. Then, other workers utilized this technique.68–72 We suggest that this procedure can be undertaken in selected patients who require palliation of pulmonary oligemia but are not amenable to total surgical correction, obstruction at the pulmonary valve level is an important component of the right ventricular outflow tract narrowing and multiple obstructions in series exist.67,73–78 We have also shown improvement in anatomy of the defect complex at follow-up assessment so that total surgical correction could be performed later.67,73–77
 
Stenotic Bioprosthetic Valves
Bioprosthetic valves and valve conduits degenerate with calcific changes. Such changes have been observed in all types of bioprosthetic valves, irrespective of the manufacturer,77,78 leading to obstructed valves. Degenerative changes appear to be more frequent and more rapid in younger children than in older children and adults. Valve leaflet stiffening and calcium deposits along the commissures, producing commissural fusion result in valve obstruction. Additionally, narrowing at the anastomotic sites of the conduit may also develop. Surgical replacement of the prosthetic valve has been the usual treatment option. Lloyd, Waldman and their associates79,80 have used balloon dilatation to relieve obstructive porcine heterografts in pulmonary position; these reports appeared in the literature almost simultaneously. These and other studies78–80 indicate significant reduction in the gradient and either avoidance or postponement of replacement of the prosthetic valve.78 Similar balloon dilatation techniques were used to open up bioprosthetic valves in tricuspid,81 mitral82 and aortic83 positions with significant improvement of hemodynamic status.78 But, balloon dilatation of bioprosthetic valves on the left side may have potential complications, particularly of dislodgment and systemic embolization of calcific debris and fractured valve leaflets. Embolic-protecting devices to capture embolized material have been designed and used effectively.84
 
Other Lesions
Stenotic lesions of the heart and great vessels that occur less frequently have also been treated with balloon angioplasty/valvuloplasty.85 The initial reports, to my 6knowledge, are as follows: Congenital tricuspid2,86,87 and mitral88 stenosis, truncal valve stenosis,89 subvalvar pulmonary stenosis,90,91 supravalvar pulmonary stenosis (congenital membranous92 or postoperative93,94), stenosis of the aorta (Leriche syndrome,95 atherosclerotic96 and Takayasu's arteritis97,98), baffle obstruction following Mustard99 or Senning procedure100 (both systemic99,100 and pulmonary101 venous obstructions), superior102,103 and inferior104–106 vena caval obstructions, pulmonary vein stenosis,17 pulmonary veno-occlusive disease,107 vertical vein stenosis in total anomalous pulmonary venous connection,108 pulmonary venous obstruction following repair of total anomalous pulmonary venous obstruction,85 especially designed pulmonary artery bands,109,110 cor triatriatum,111 cor triatriatum dexter112 and coronary artery stenotic lesions that develop after Kawasaki disease.113 The interested reader is referred elsewhere85 for more detailed discussion of these lesions/procedures.
 
TRANSCATHETER OCCLUSION OF CARDIAC DEFECTS
Transcatheter closure of PDA was first described by Porstmann and his colleagues in 1967.6 Later, King114 in 1974 and Rashkind115 in 1975 experimented with two different devices to occlude atrial septal defects (ASDs). The historical aspects of each cardiac septal defect will be reviewed separately in the ensuing paragraphs.
 
Atrial Septal Defect
For a more detailed description of historical aspects of transcatheter occlusion of ASDs, the reader is referred to our prior publications.116,117 King and Mills114 were the first to address the concept of transcatheter occlusion of ASDs. They described a device consisting of two Dacron-covered stainless steel umbrellas, which may be collapsed into a capsule, located at the tip of a catheter and utilized it to close ASDs created by a punch biopsy technique in adult dogs. They successfully deployed the device in five of nine dogs in whom they attempted the procedure. During the follow-up, complete closure of the ASD and endothelialization of the implanted device were seen. Subsequently they applied the technique to human subjects.118,119 Balloon sizing120 was used to measure the stretched diameter of the ASD, and they used devices 10 mm larger than the stretched ASD diameter. Cardiac catheterization was performed in 18 patients and 10 (56%) patients were found suitable for device closure of the ASD. Five (50%) of these 10 patients had successful deployment of the device. Oximetry did not show any residual shunts.
A slightly different type of ASD occluder device was conceived by Rashkind.121,122 The initial Rashkind device consisted of an umbrella with three stainless-steel arms covered with foam; this was subsequently modified so that there are six stainless steel arms with every other arm impregnated with a miniature “fish” hook. The central ends of the arms were attached to miniature springs, which in turn, were welded to a small central hub. An intricate centering mechanism, made up of five arms bent to produce a mild outward curve was integrated into the device delivery system. The umbrella device and the centering system may be collapsed into a pod and loaded into a 14 F or 16 F long sheath. A device that is roughly twice the stretched diameter of the ASD is selected for implantation. Initially these devices were used to close surgically created ASDs in dogs and calves. These experimental studies indicated feasibility of the method along with excellent endothelialization of the umbrella.
The author was privileged to spend a mini-sabbatical with Dr William Rashkind in mid-1979, during which time had the opportunity in performing ASD device closures with the hooked device, both in calf model and in patients under the tutelage of Rashkind. Rashkind's dedication and enthusiasm in developing transcatheter occlusion techniques is laudable and the diligence with which he pursued the project is admirable. Subsequently, Rashkind obtained investigational device exemption from the Food and Drug Administration (FDA) and began conducting multi-institutional clinical trials in early 1980s. This would appear to be the first clinical trial for device closures in pediatric-cardiac practice. Unfortunately, Rashkind did not live to witness the conclusion of these trials or to see the monumental effect that his work had on the evolution of transcatheter occlusion technology.
Rashkind extended the use of this method to human subjects;121–123 he evaluated 33 patients for device implantation and found that the ASD was either too large to be able to implant the device or too small to need closure in 10 patients. In the remaining 23 patients, the ASD device was delivered across the ASD and 14 (61%) had adequate closure. The results were unsatisfactory in nine (39%). Rashkind modified this device into a double-disk prosthesis122 based on identified problems. This change was patterned after a PDA device124 that he was concurrently developing.
Lock and his colleagues125 modified Rashkind's device by introducing a bend in center of the arms because of the umbrellas did not fold back against each other; the modified version was called clamshell occluder. This device was successfully implanted in six of eight lambs in whom they attempted the procedure.125 These investigators then implanted clamshell device in 17 human subjects;126 no residual shunts were seen in the majority of patients both immediately after and 6 month following device implantation. Transesophageal echocardiographic (TEE) monitoring during the procedure was first advocated by Hellenbrand et al.127 Clinical trials by these investigators continued and other workers started clinical trials, but because of development of fractures of the device arms in 40–84% of devices along with occasional embolization,128,129 ongoing 7clinical trials with the device were suspended by the FDA and the investigators in 1991.
Subsequent to these initial efforts to percutaneously occlude ASDs, a large number of other devices were designed and tested. Most of the devices were experimented initially in animal models and then on human subjects. These devices were: Original buttoned device,130,131 atrial septal defect occluding system (ASDOS),132 second- and third-generation buttoned devices,133,134 monodisk device135 Das-Angel-Wing device,136 modified Rashkind PDA umbrella device,124,137 centering buttoned device,138 inverted buttoned device to address closure of right-to-left shunts,139 Amplatzer® septal occluder,140,141 CardioSEAL® device,142 STARFlex device,143 fourth-generation buttoned device,144,145 Sideris’ wireless devices including transcatheter patch,146,147 HELEX® septal occluder,148,149 centering-on-demand buttoned device to center the device in the ASD when required,150 fenestrated Amplatzer® device to keep ASDs open to maintain cardiac output,151 hybrid buttoned device to address closure of defects associated with atrial septal aneurysm,152 cribriform device to occlude multiple or fenestrated ASDs,153 BioSTAR®,154,155 nanoplatinum coating to prevent nickel release from Amplatzer® devices, thus averting Kounis syndrome,156 Solysafe septal occluder device,157 BioTREK device,158 Occlutech septal occluder,159 ATRIASEPT I-ASD device,160 ATRIASEPT II-ASD and ULTRASEPT,161 the pfm ASD-R device,162 biodegradable polycaprolactone occlusion device163 Nit-Occlud ASD-R® (NOASD-R) device,164 Lifetech Cera165 and others. Other devices, such as Cardi-O-Fix septal occluder, Heart R septal occluder and others that may have escaped detection during our literature search, may be in the process of development.
In spite of many studies with different devices, Amplatzer® septal occluder, Amplatzer® cribriform device and HELEX are the only devices that are approved for general clinical use by the FDA in the United States (US). A number of other devices are in clinical trials, either in the US or in other countries. The interested reader is referred elsewhere,116,117 for a more detailed description of the devices and initial clinical trials.
 
Patent Foramen Ovale
Although a patent foramen ovale (PFO) is considered as a normal variant and present in nearly one-third of normal population, shunting across it is presumed to be producing: (i) Cerebrovascular accidents, especially in young adults; (ii) Hypoxemia in the elderly with platypnea-orthodeoxia syndrome; (iii) Cyanosis in patients who were previously treated for complex congenital cardiac defects including intentional fenestrations; (iv) Arterial oxygen desaturation in patients who had right ventricular infarction; (v) Decompression (Caisson's) illness; (vi) Migraine. The initial report of percutaneous closure of such a defect was with King's device in 1976;118,119 Mills and King closed an atrial defect with a 25-mm device in a 17-year-old young man who sustained a stroke due to paradoxical embolism. Several years later, Bridges,166 Rao133 and their colleagues concurrently reported the use of clamshell and buttoned devices, respectively, to close PFOs. This was followed by use of this concept and method of PFO occlusion by a number of investigators, referenced elsewhere.167,168 Most of the devices depicted in the preceding ASD section were used to close PFOs as and when the devices became available. Some of the existing ASD occlusion devices were modified and some new devices were designed specifically to address the anatomic features of the PFO. These devices are Amplatzer® PFO occluder,169 PFO-Star and several subsequent generations of cardia devices,161,170 Premere occluder,171 Occlutech septal occluder,172 Coherex FlatStent,173 pfm PFO-R,162 Solysafe PFO occluder,157 Occlutech Figulla® PFO and ASD occluder,159 GORE® HELEX septal occluder174 Atriasept™ II PFO occluder,175 Nit-Occlud® PFO176 and others.
Some of these devices are in clinical trials around the world, and to the best of my knowledge, none are approved by FDA for general clinical use at the present time. The Amplatzer® cribriform device,153 which has features similar to Amplatzer® PFO occluder,169 has been successfully used on an off-label basis to occlude PFOs.177 PFx™ closure system178 employs monopolar radiofrequency energy to effect closure of a PFO by welding the tissues of the septum primum with the septum secundum; this is not a device but was successfully used to close PFOs.
 
Patent Ductus Arteriosus
Porstmann and his colleagues6,179,180 described a PDA occluding device in late 1960s and were the first to do so to close PDAs and paved the way for the development of other devices for PDA closure. Their device is made up of a conical-shaped Ivalon foam plug and is custom-designed based on the shape and size of the ductus on lateral view of an aortogram. A guidewire is passed from the femoral artery, into the aorta and via the ductus into the pulmonary artery, right ventricle, right atrium, inferior vena cava to the femoral vein and a wire loop from the femoral artery-to-femoral vein was first established. The Ivalon foam plug is introduced over the guide wire into the femoral artery with the help of a tubular applicator, and the plug is pushed with a catheter and positioned well into the ductal ampulla. After ensuing good position of the device within the PDA, the guidewire loop is withdrawn from the femoral vein. Studies in animal models were first performed followed by human application. In the initial cohort of 62 patients, successful PDA occlusion was accomplished in 90% patients. In the remaining 10% patients, it was not technically possible to implant the Ivalon foam plug. During a follow-up up to 4.5 years, the data revealed no recurrence of the shunt.180
A polyurethane foam-covered umbrella with miniature fish hooks was designed to occlude the PDA by Rashkind.124,181 8The device is connected to the delivery system by a simple eye pin and sleeve mechanism and can be loaded into a 6 F sheath. The device is introduced into the femoral artery, advanced into the ductus retrogradely, allowed to expand within the ductus, facilitating embedding the fish hooks within the ductal wall and the device released. The implantation rate was 100% in the calf model. The first patient they tried this method was a 3.5 kg infant; there was a fall in pulmonary artery pressure and follow-up angiography revealed no residual shunt.181 In the first series of 20 patients, successful implantation occurred in 17 patients with complete closure in half of these patients. Device embolization also occurred. In view of multiple problems observed with the hooked device, Rashkind redesigned the device and made it into a double-disk device without hooks.124 The double-disk device is composed of two opposing polyurethane foam covered umbrellas with three stainless steel arms. This device is delivered transvenously; one umbrella is delivered into the aortic end of the ductus and the other umbrella into the pulmonary arterial side of the ductus. Initial testing in animal models revealed successful implantation in all.122 In Rashkind's initial clinical experience three (38%) of the eight PDAs were very large and no closure was attempted, four (50%) PDAs were completely closed and one (13%) had an incomplete closure. Multicenter FDA trial124 observations revealed successful closure in 94 (64%) of 146 patients. Device embolization in 19 (15%) and significant residual shunts in 15 (10%) were seen.124 Additional clinical trials showed some improvement of results; however, the device did not receive FDA approval.
Several other devices were designed and used in experimental animal models, but did not advance to reach clinical trials in human subjects and these are dumbbell-shaped plug,118 cylindrical Ivalon sponge plug tied securely to a stainless steel umbrella,182 detachable silicone double-balloon,183,184 conical nylon sack filled with segments of modified guidewire with a 1.5 cm long flexible wire crossbar attached to the distal end of the sack,185 temperature-shape changeable, shape-memory polymer (polynorbornene),186 butterfly vascular stent plug,187 conical-shaped stainless steel wire mesh,188 thermal shape-memory nickel-titanium coil,189,190 miniaturized duct-occluder pfm,191 retrievable PDA plug,192 double-cone shaped, stainless steel coils with enhanced stiffness of the outer rings,193 valved stent,194 and devices made up of biodegradable polymer blends.195 Most of these devices were described elsewhere196–198 and will not be reviewed.
A number of other devices had been through clinical trials in human subjects, and the majority of these had been investigated in animal models preceding clinical trials. These include: botallooccluder,199 buttoned device,200–202 clamshell septal umbrella,203 Gianturco coil,204 Duct Occlud pfm,205 detachable (Cook and Flipper) coils,206–208 Gianturco-Grifka vascular occlusion device (GGVOD),209 polyvinyl alcohol (Ivalon R) foam plug,210 infant buttoned device,211,212 Amplatzer® duct occluder,213,214 folding plug buttoned device,215 wireless PDA devices,216,217 reinforced duct-occlude pfm,218 Amplatzer® muscular ventricular septal defect (VSD) occluder,219 Amplatzer® vascular plug,220 Nit-Occlud® coils,221 Inoue single-branched stent graft,222 nonferromagnetic Inconel MReye embolization coils,223 Amplatzer® vascular plug with prefilled embolization coils,224 self-expanding platinum-coated Nitinol device,225 Chinese self-expandable occluder,226 similar to the Amplatzer® occluder, Amplatzer® vascular plug II,227 Cardio-O-Fix occluder,228 Nit-Occlud® PDA-R (reverse) device,229–231 and perhaps, others that may have escaped our literature search. For the interested reader, some of these devices have been described in a greater detail elsewhere.196–198
Cambier et al.204 used Gianturco coils (originally described232 to close blood vessels in 1975) to occlude PDAs. Since that time a number of refinements and alterations of both coil and technique have been introduced. These are: snare-assisted coil implantation,233 detachable coils,206–208 antegrade coil placement,234 multiple coil delivery,234 bioptome-assisted coil deployment,235 temporary balloon occlusion of the ductus on the aortic,236 or pulmonary artery237 side during coil implantation, five loop coil use,238 increasing the wire diameter to 0.052-in,239 coil delivery via a tapered tip catheters,240,241 and coil implantation without use of heparin.242 Similarly, a number of modifications were introduced following initial description213,214 of Amplatzer® duct occluder. These modifications include Amplatzer® angulated nitinol plug,243,244 Amplatzer Swivel disk and plug occluder245 and Amplatzer® duct occluder II.227,246
Even though several devices have been studied, only a small number of devices are approved by FDA for clinical use. These include Gianturco coils (free and detachable), GGVOD, Amplatzer® duct occluder, Amplatzer® duct occluder-II and most recently, Nit-Occlud® PDA device. A number of other devices are in clinical trials around the world; the interested reader referred elsewhere196–198 for a more detailed description of some of these devices.
 
Ventricular Septal Defect
The first description of transcatheter closure of VSDs was reported by Rashkind;115 he utilized hooked single-disk device in experimental dog model to achieve this. Thereafter, Lock and his associates247 employed Rashkind's double-disk PDA umbrella124 in human subjects; the device was successfully deployed in six of the seven patients in whom they attempted procedure. In the seventh patient, the device was embolized into the pulmonary artery. Goldstein et al.248 used clamshell occluders to close the VSDs. Occlusion of muscular VSDs perioperatively249 in complex CHDs as a part of overall management was undertaken at the same institution. Then, other devices to close the VSD were described, which include buttoned device,250,251 Amplatzer® muscular VSD device,252,253 detachable steel coil,254 Gianturco coils,255 Amplatzer® membranous VSD occluder,256 wireless devices (detachable 9balloon and transcatheter patch),257 CardioSEAL/STARFlex devices,258 Nit-Occlud® (nickel-titanium spiral coil),259 Amplatzer® duct occluder,260 Amplatzer® duct occluder II,261 and CERA devices.262
The VSD closure techniques were also extended to occlude postmyocardial infarction VSDs; a number of devices have been used and include Rashkind's double-disk PDA umbrella,247 clamshell,263 CardioSEAL and STARFlex,263 Amplatzer® septal occluder,264 Amplatzer® postinfarct muscular VSD (PIMVSD),265 Amplatzer® duct occluder266 and CERA267 devices.
So far approval by the FDA has been granted for Amplatzer® muscular VSD and PIMVSD occluders, and CardioSEAL® septal occlusion system with QwikLoad and STARFlex septal occlusion system. While the Amplatzer® membranous VSD occluder has been used on an investigational basis, onset of heart block, reviewed elsewhere,268 appears to have resulted in suspension of clinical trials in the US. Several other devices appear to be undergoing clinical trials either in the US or other countries and may only be used at institutions participating in clinical trials.
 
Aortopulmonary Window
The first report of transcatheter occlusion of aortopulmonary window (APW) was documented by Stamato et al.;269 they used Rashkind's double umbrella PDA device. Following that report other investigators used buttoned,270 Amplatzer® duct occluder,271 Amplatzer® septal occluder,272 Amplatzer® muscular VSD occluder,273 Amplatzer® perimembranous VSD occluder273 and Shen-Zhen Lifetech Scientific Inc's muscular VSD occluder274 devices to occlude APWs. All investigators,269–274 as reviewed elsewhere,275 indicate that the APW is an infrequent congenital cardiac defect and only a few of APWs are of sufficiently small in size to be amenable to percutaneous occlusion.
 
CATHETER-BASED ATRIAL SEPTOSTOMY
 
Rashkind Balloon Atrial Septostomy
Rashkind and Miller3 were the first to describe balloon atrial septostomy; this was in 1966 and was the only transcatheter therapeutic technique available for use in children until early 1980s. This procedure, now called Rashkind balloon atrial septostomy has been used widely to augment mixing at atrial level in babies with transposition of the great arteries. Rashkind septostomy technique was later applied to relieve obstruction at atrial septum in babies with tricuspid atresia,276 pulmonary atresia with intact ventricular septum,277 total anomalous pulmonary venous connection278 and hypoplastic left heart syndrome including mitral atresia.3,279
In the initial description of septostomy,3 Rashkind introduced catheter into the femoral vein by performing cut-down in the groin. Insertion of the catheter via the umbilical vein280 and by percutaneous technique281 was later used to avoid femoral venous cutdown. While the procedure is generally performed in the catheterization laboratory, the feasibility of undertaking the balloon septostomy bedside, under echo guidance,282 has been shown.
 
Park's Blade Atrial Septostomy
In neonates with hypoplastic left heart syndrome and in older patients, the lower margin of the PFO (septum primum) is thick and cannot be torn by Rashkind balloon septostomy. In such situations, balloon septostomy may merely stretch and not tear the lower margin of the PFO. To address this problem, Park and his associates283,284 designed catheters with built-in blade (knife) to cut thick atrial septae. The lower margin of the PFO is incised by gently pulling an appropriately positioned catheter and then conventional balloon septostomy is performed.
 
Balloon Angioplasty of the Atrial Septum
Static balloon dilatation or balloon angioplasty of the atrial septum in animal models was reported by Mitchell,285 Sideris286 and their colleagues. To my knowledge, these investigators did not extend the technique to human subjects. Shrivastava and her associates287 were the first to report clinical use of this technique in a newborn infant with transposition of great arteries. Subsequently, other workers, including the author288–291 utilized this technique effectively.
 
Transseptal Puncture
In some babies, there is no PFO and the atrial septum is intact. In such circumstances, the atrial septum cannot be traversed with the usual catheters. Transseptal puncture as described by Ross and Brockenbrough292,293 has been extensively used in adult subjects.293 Brockenbrough transseptal puncture technique was then extended to pediatric patients294 and more recently to newborn babies.295 Instead, radiofrequency perforation296 may be used to cross the atrial septum. Once in the left atrium, either static dilatation of the atrial septum (see the preceding section) or cutting balloon septoplasty297 or stent implantation (see the next section) may have to be undertaken to keep the atrial defect open.
 
Atrial Septal Stents
There is a natural tendency for spontaneous closure of dilated atrial septal openings. To address this problem, the author suggested using stents to keep the defects open as he was discussing state of the art, and future directions in interventional pediatric cardiology in 1998.298 The very next year Atz and associates295 reported placing a stent across the atrial septum following needle puncture of intact atrial 10septum in a newborn with hypoplastic left heart syndrome. Other investigators reported their experiences with atrial septal stents later.299,300
 
ENDOVASCULAR STENTS
Dotter and Judkins5 proposed the concept of stents while describing transluminal balloon dilatation in 1964. Five years later, Dotter301 designed and implanted spiral coil-spring device into peripheral artery stenotic lesions produced in an animal model. Self-expanding double helical spiral stents were implanted in experimentally created vascular stenotic lesions in early 1980s.302 Palmaz and his associates303–305 placed stainless steel mesh stents in the aorta, hepatobiliary circulation, coronary and other arteries of rabbits and dogs, and demonstrated the feasibility of stent concept in mid 1980s. The studies were then extended to human subjects with the use of stents in the management of stenotic lesions of the coronary,306 iliac307 and renal308 arteries in adults. Subsequently, the stent concept was applied to children.309 The technique was initially employed to treat stenotic lesions of branch pulmonary arteries and systemic veins.309 Later the stent usage was extended to treat obstruction lesions in the systemic310 and pulmonary311 venous pathways after Mustard procedure, aortic coarctaion,312 right ventricular outflow conduits,313 pulmonary veins314,315 and native right ventricular outflow tract.316 Stents were also employed to maintain the PDA open in babies with pulmonary atresia,317 hypoplastic left heart syndrome,318 opening up of the stenosed aortopulmonary collateral vessels,319 obstructed surgical shunts320 or acutely thrombosed shunts.321 Additional changes of stents, namely covered stent (covered with polytetrafluoroethylene membrane) to treat aortic coarctation,322 biodegradable,323 and Growth324 stents to circumvent problems associated with growth of the children and drug-eluding stents325 to prevent neointimal proliferation have been undertaken. Stents were also used in hybrid procedures to complete Fontan by a staged surgical-catheter approach326 and to stent the ductus (and PFO if necessary) along with surgical bilateral branch pulmonary artery banding in the palliation of hypoplastic left heart syndrome.327
 
OTHER TRANSCATHETER INTERVENTIONS
Perforation of atretic pulmonary valve with blunt guide wire328,329 laser330,331 or radiofrequency perforation331 have been described. A number of other transcatheter interventions such as transcatheter occlusion of unwanted superfluous vascular lesions such as cerebrovascular and hepatic arteriovenous fistulae, multiple aortopulmonary collateral vessels associated with pulmonary atresia with VSD (tetralogy of Fallot), anomalous systemic artery associated with pulmonary sequestration/scimitar syndrome and venovenous or arteriovenous collateral vessels associated with bidirectional or Fontan procedures have been reviewed elsewhere.332,333 Transcatheter valve replacements and others are not reviewed here because limitations of space.
 
CONCLUSION
Rubio-Alvarez et al. in 1953 were the very first to perform and report transcatheter intervention to treat congenital cardiac defects; they performed pulmonary valvotomy using a modified ureteral catheter. Ten years later Dotter, Rashkind, Porstmann and their associates described progressive dilatation of peripheral arterial stenotic lesions, balloon atrial septostomy and transcatheter occlusion of PDA, respectively. In this review, historical aspects of catheter-based interventions in the treatment of heart disease in children were reviewed. Historical aspects of: (i) Balloon angioplasty/valvuloplasty of valvar pulmonary stenosis, valvar aortic stenosis, fixed subaortic stenosis, native aortic coarctation, postsurgical aortic recoarctation, branch pulmonary artery stenosis, mitral stenosis, cyanotic heart defects with pulmonary oligemia, stenotic bioprosthetic valves, congenital tricuspid and mitral stenosis, truncal valve stenosis, subvalvar pulmonary stenosis, supravalvar pulmonary stenosis (congenital membranous or postoperative), stenosis of the aorta (Leriche syndrome, atherosclerotic and Takayasu's arteritis), baffle obstruction following Mustard or Senning procedure (both systemic and pulmonary venous obstructions), superior and inferior vena caval obstructions, pulmonary vein stenosis, pulmonary veno-occlusive disease, vertical vein stenosis in total anomalous pulmonary venous connection, pulmonary venous obstruction following repair of total anomalous pulmonary venous obstruction, specially designed pulmonary artery bands, cor triatriatum, cor triatriatum dexter and coronary artery stenotic lesions that develop after Kawasaki disease; (ii) Transcatheter occlusion of cardiac defects comprising of ASD, PFO, PDA, VSD and APW; (iii) Catheter-based atrial septostomy, such as Rashkind balloon atrial septostomy, Park's blade atrial septostomy, balloon angioplasty of the atrial septum, transseptal puncture and atrial septal stents; (iv) Endovascular stents to enlarge stenotic lesions of branch pulmonary arteries, systemic veins, systemic and pulmonary venous pathways after Mustard procedure, coarctation of the aorta, right ventricular outflow conduits, pulmonary veins and native right ventricular outflow tract or to keep the ductus arteriosus open in patients with pulmonary atresia and hypoplastic left heart syndrome and maintaining patency of stenosed aortopulmonary collateral vessels, surgically created but obstructed shunts or acutely thrombosed shunts as well as covered stents and (v) Others were presented.
Let food be thy medicine and medicine be thy food.
—Hippocrates
11
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