Atrial Septal Defects
Atrial septal defects account for about one-third of all congenital heart abnormalities detected in adults.1 A large defect in adult patients results in symptoms and complications such as arrhythmias, cardiac failure and pulmonary hypertension.1,2 The first transcatheter device closure of an atrial septal defect was described in 1976.3 Today, percutaneous closure of this defect is widely practiced using different types of devices and has replaced surgical closure of a simple secundum atrial septal defect in most centers.4–13
Worldwide data and experiences. Although many devices have been developed for catheter closure of secundum-type defects, three devices are used in the majority of centers: the CardioSEAL®/STARFlex® (NMT Medical, Inc, Boston, Massachusetts), the Amplatzer® Septal Occluder (AGA Medical Corp., Golden Valley, Minnesota), and the Helex septal occluder (Gore Medical [WL Gore & Associates, Inc.], Flagstaff, Arizona). The Amplatzer septal occluder is currently the most widely used device because it is easy to implant and it allows closure of large orifices with excellent success rates in most patients. It was first used in a human in 1995. Device closure is currently not amenable to ostium primum and sinus venosus defects.
Several nonrandomized studies have compared transcatheter closure to surgery.14–16 In these studies, shunt closure was achieved in 92–99% after interventional closure and in 98–100% after surgery. In a worldwide survey published by Omeish et al (mean age 12 years; 3,460 patients with a secundum atrial septal defect and a defect diameter of < 35 mm; treated with an Amplatzer septal occluder), the immediate sealing rate was 97%, at 6-month follow up it was 98%, at 1-year follow up it was 99%, and after 2 years, the rate was 100%.17
Carminati et al showed in a multicenter trial that 99% (310/314) of the patients treated with the CardioSEAL or STARFlex devices had no residual shunt immediately after the procedure.18 After 1 year, complete closure of the defect was achieved in 93% of the patients. Jones et al published the results of the U.S. multicenter pivotal study of the HELEX septal occluder for percutaneous closure of secundum atrial septal defects. Closure with the Gore HELEX® septal occluder device (W.L. Gore & Associates), compared to surgical closure, showed a similar complete closure rate in both groups. The Helex device was safe and effective when compared with surgical repair and resulted in reduced anesthesia time and hospital stay.19 The complication rates in all studies were consistently low.17–25 Severe complications like malpositioning and subsequent surgery occurred in 1–5%, embolization of the device in 0.4–4%, stroke in 0.1–0.3%, cardiac tamponade in 0.1%, cardiac perforation in 0.03% and endocarditis in 0.03% of patients.
Personal data and experiences. Since August 1992, percutaneous atrial septal defect closure was attempted in 819 adult patients (619 females and 200 males, mean age 47.2 ± 17). Table 1 shows the occluders that were implanted. The defects measured by balloon sizing ranged from 3.1 to 43 mm (mean 19.8 ± 6.7). One hundred five patients (13%) showed multiple defects. The mean quotient between pulmonary blood circulation and systemic circulation (Qp:Qs) was 1.9 ± 0.7, and the mean systolic pulmonary artery pressure was 33.3 ± 10.6 mmHg. Device implantation was eventually successful in 99%; in 44 patients, more than 1 device was implanted either during the same procedure or in a second procedure. The mean fluoroscopy time, including diagnostics, was 8.8 ± 9 minutes. Complications during hospital stay were death (0.1%; sudden death 3 days after procedure), need for surgical intervention (0.5%; 2 perforations of the aortic root, 1 device embolization, 1 thrombus), embolization (0.5%) and pericardial effusion (0.5%).
After discharge and during follow up (in total, 1,723 patient years), no device-related deaths occurred; 5.9% of the patients had minor complications such as cardiac arrhythmias, asymptomatic thrombi (0.9%; all resolved under medical therapy) and pericardial effusion (0.9%; no sequelae); and 0.9% of the patients sustained a transient ischemic attack or minor stroke. During follow up, complete closure was achieved in 92% of the patients. The Qp:Qs ratio was reduced to mean levels of 1.0 ± 0.3, and the mean systolic pressure dropped to 28.3 ± 10.1 mmHg.
Ventricular Septal Defects
Over the last few years, percutaneous closure of ventricular septal defects has become an alternative to surgical repair.26 Several devices have been used for this purpose: the Sideris buttoned device, the Rashkind device, Gianturci coils, the Clamshell device, the CardioSEAL® and CardioSEAL/ STARFlex device, the Amplatzer occluder family and the Nit-Occlud® coils (Pfm AG, Cologne, Germany). Technically, ventricular septal defect closure is a more difficult procedure when compared to transcatheter atrial septal defect or patent foramen ovale closure. Its success necessitates precise anatomic definition of the defect and its relation to other cardiac structures. Depending on their location within the septum, defects can be classified as muscular or perimembranous. The most common defects are the perimembranous ventricular septal defect (approximately 70%), while muscular defects may occur in around 15% of patients. Indications for ventricular septal defect closure are symptoms of heart failure, signs of right-heart chamber overload and a history of endocarditis. In patients with an overload of right-heart chambers, closure is necessary in order to prevent pulmonary arterial hypertension, ventricular dysfunction, arrhythmias and aortic regurgitation. Ventricular septal rupture is a severe complication of myocardial infarction.27 Device closure is feasible, but even more difficult than in congenital ventricular septal defects.
Worldwide data and experiences. Percutaneous closure of a ventricular septal defect remains one of the most challenging procedures in interventional cardiology. Chordae tendinae, aortic and tricuspid valves, high pressure in the left ventricle and disparity of the interventricular tissue represent tricky obstacles for final device attachment (further complicated by ventricular septal aneurysms and a multiperforated septum). Compared to percutaneous atrial septal defect closure, ventricular septal defect closure requires venous and arterial access to establish an arteriovenous wire loop. Muscular defects have been closed with transcatheter devices for the past 15 years. Although perimembranous defects are more common than muscular defects, they have become more amenable to closure since the introduction of the Amplatzer® Membranous Ventricular Septal Defect Occluder. Of all ventricular septal defect occluding systems, the Amplatzer products (atrial septal defect device, membranous and muscular ventricular septal defect occluder, eccentric and concentric ventricular septal defect occluders, persistent ductus arteriosus device), the Nit-Occlud coils and the STARflex device have been the most effective in providing stable results. Surgical closure of ventricular septal defects is generally safe, but death may occur in 0.6–5% of patients.28–32 Additionally, the procedure is associated with significant morbidity including complete atrioventricular block in 1–5% of cases,28,29,33,34 and significant residual shunting in 1–10% of patients.28,30,31,35 Percutaneous ventricular septal defect closure has been reported in the literature (Table 2). While ventricular septal defect closure in the 1980s and early 1990s was rather risky, results have improved with the new generation of ventricular septal defect coils and occluders.
Personal data and experiences. Ventricular septal defect closure was attempted in 56 patients (23 females and 33 males, mean age 45 ± 21.6 years). Devices were implanted as follows: 16 Nit-Occlud coils, 8 muscular and 17 membranous Amplatzer devices, 12 atrial septal defect Amplatzer devices, 1 patent foramen ovale Amplatzer and 3 patent ductus arteriosus Amplatzer devices. In 5 patients, a second device was implanted during a second procedure due to residual shunting. In 12 patients, the ventricular septal defect was located at the muscular part of the septum, and at the perimembranous part in 33 patients. All perimembranous ventricular septal defect patients were either treated with a membranous Amplatzer device or a Nit-Occlud coil. The mean ventricular septal defect diameter measured invasively was 7.2 ± 4.2 mm. Altogether, myocardial infarction was the origin of a ventricular septal defect in 9 patients, and 1 patient suffered from traumatic rupture of the septum.
Transcatheter occlusion was successful in 93% (57/61) of the procedures. Five patients underwent a repeat transcatheter device implantation due to residual leakage. One patient with a post myocardial infarction ventricular septal defect died within 12 hours of the implantation. Another patient with a ventricular septal defect after myocardial infarction was sent to surgery after the successful implantation of an Amplatzer atrial septal defect occluder due to recurrent ventricular tachycardia. In 1 patient with a congenital perimembranous ventricular septal defect, 2 Amplatzer devices embolized into the right chamber. Both occluders were successfully rescued by catheter techniques in the same procedure, and the third implant was released in an optimal position. After a mean follow up of 18.2 ± 18.6 months, only 8 patients (14%) showed residual shunting, which was minor in all of them.
It is now well accepted that transcatheter closure is the standard technique for atrial septal defect closure. It is as effective as surgery, but with less morbidity. Long-term follow-up data on ventricular septal defect occlusion are still lacking. Furthermore, closure of ventricular septal defects is a more complex and challenging procedure that requires technical expertise and precise delineation of the defect and its relation to other cardiac structures. A broad repertoire of devices is necessary, since ventricular septal defect position, form and complications are quite variable. Nevertheless, transcatheter closure is a safe and effective procedure in selected patients and a good alternative given the high morbidity and mortality rates associated with surgical closure of ventricular septal defects.
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