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Intracardiac Echocardiographic Guidance During Transcatheter Device Closure of Atrial Septal Defect and Patent Foramen Ovale
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Mayo Clin Proc, January 2004, Vol 79
Original Article
Intracardiac Echocardiographic Guidance During Transcatheter Device Closure of Atrial Septal Defect and Patent Foramen Ovale MICHAEL G. EARING, MD; ALLISON K. CABALKA, MD; JAMES B. SEWARD, MD; CHARLES J. BRUCE, MD; GUY S. REEDER, MD; AND DONALD J. HAGLER, MD
• Objectives: To describe our experience with intracardiac echocardiographic (ICE) guidance during transcatheter device closure of atrial septal defect (ASD) and patent foramen ovale (PFO) and to describe a detailed stepwise approach for performing ICE examinations. • Patients and Methods: We reviewed the ICE results of all patients who underwent transcatheter device closure of ASD/PFO at the Mayo Clinic in Rochester, Minn, between October 2000 and November 2002. Conscious sedation was used, and all ICE studies were performed using a diagnostic ultrasound catheter. • Results: Ninety-four patients (47 male; median age, 51 years [range, 17-81 years]) underwent ICE during transcatheter device closure of ASD/PFO. Total procedure time was 128 minutes (range, 27-320 minutes). ICE identified a previously unrecognized anatomical diagnosis in 32 of 94 patients. An additional ASD or PFO was found in 16 patients; a redundant atrial septum or an atrial septal aneurysm was found in 12 patients. There were few ICE complications (4%): 3 patients developed atrial fibrillation,
and 1 developed supraventricular tachycardia; of these 4, 2 resolved spontaneously, and 2 required cardioversion with no recurrence. • Conclusion: ICE provides anatomical detail of ASD/ PFO and cardiac structures facilitating congenital cardiac interventional procedures. ICE eliminates major drawbacks related to the use of transesophageal echocardiographic guidance for transcatheter device closure of ASD/ PFO, specifically problems related to airway management. Finally, ICE gives the interventional cardiologist the ability to control all aspects of imaging without relying on additional echocardiographic support. We believe that ICE should be considered the preferred imaging technique for guidance of transcatheter device closure of ASD/PFO in adults and larger pediatric patients. Mayo Clin Proc. 2004;79:24-34 ASD = atrial septal defect; ICE = intracardiac echocardiography; PFO = patent foramen ovale; TEE = transesophageal echocardiography; TTE = transthoracic echocardiography
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catheter device closure of ASD and PFO is limited; therefore, we reviewed our experience with ICE guidance during attempted transcatheter device closure of ASD and PFO. The objectives of this study were to determine the safety and efficacy of ICE guidance during transcatheter device closure of ASD/PFO and to describe a detailed stepwise approach for performing the ICE examination.
ince first attempted by King and Mills in 1976, transcatheter device closure of atrial septal defect (ASD) and patent foramen ovale (PFO) has become an effective and safe alternative to surgery.1-7 Echocardiographic guidance during device closure of ASD and PFO is now standard practice. Transesophageal echocardiography (TEE) has been used most commonly but has associated limitations, specifically the need for general anesthesia and potential problems related to airway management in the supine patient.8,9 Recently, several small studies have shown that intracardiac echocardiography (ICE) using the AcuNav diagnostic ultrasound catheter (Acuson Corp, Mountain View, Calif) is a feasible and accurate alternative imaging modality for transcatheter device closure of ASD and PFO.10-13 Overall experience with ICE-guided trans-
For editorial comment, see page 15. PATIENTS AND METHODS Between October 2000 and November 2002, 94 patients underwent ICE during attempted transcatheter device closure of ASD/PFO at the Mayo Clinic in Rochester, Minn. Before referral, all patients had undergone transthoracic echocardiography (TTE), and 82 of the 94 patients had undergone TEE.
From the Division of Pediatric Cardiology (M.G.E., A.K.C., J.B.S., D.J.H.) and Division of Cardiovascular Diseases and Internal Medicine (A.K.C., J.B.S., C.J.B., G.S.R.), Mayo Clinic College of Medicine, Rochester, Minn.
Intracardiac Echocardiography Overview.—Femoral venous access (11F sheath) was obtained after administration of local anesthetic, concurrent with the use of conscious sedation. ICE studies were performed using the AcuNav diagnostic ultrasound cath-
Address reprint requests and correspondence to Donald J. Hagler, MD, Division of Pediatric Cardiology, Mayo Clinic College of Medicine, 200 First St SW, Rochester, MN 55905 (e-mail: hagler.donald @mayo.edu). Mayo Clin Proc. 2004;79:24-34
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© 2004 Mayo Foundation for Medical Education and Research
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Figure 1. A, Diagnostic ultrasound catheter (AcuNav) placed adjacent to a pediatric transesophageal echocardiography probe shows the relatively small size of the 10F catheter. B, Close-up of the 3.3-mm-diameter catheter tip (arrows) shows the longitudinally oriented crystal array (palette). C, Overhead view of the 4-way tip maneuverability of the diagnostic catheter.
eter linked to a Sequoia ultrasound-imaging platform (Acuson Corp). The AcuNav ultrasound catheter is a multifrequency (5.5-10.0 MHz), 64-element vector, phasedarray transducer mounted on a 3.3-mm (10F) catheter with a maneuverable 4-way tip (Figure 1) that is capable of high-resolution 2-dimensional and full Doppler imaging (pulsed, continuous-wave, and tissue Doppler). The longitudinal plane provides a 90-degree sector image with tissue penetration of 2 to 12 cm. The ICE catheter was advanced to the right atrium under fluoroscopic guidance. Image quality was optimized by adjusting gain, depth, frequency, and focal length controls. Complete ICE evaluation of the left and right sides of the heart was then performed. Detailed Description of ICE Examination.—Movements described relate to the manipulation of the control mechanisms on the handle of the ICE catheter. Movement of the control handle to the left of midline results in movement of the catheter tip to the left as visualized from the front of the probe handle. However, these movements may not result in movement of the catheter tip in the same direction as illustrated outside of the body because during an examination, the imaging palette is also being rotated in various directions to achieve a particular image plane. Thus, if the probe is oriented to visualize a posterior structure (palette-directed posterior), posterior manipulation of the probe handle controls results in a more anterior position (anterior flexion) of the catheter tip. When the catheter is angulated into unusual positions, such as the position required to achieve a short-axis image plane (posterior and rightward control movement), simple rotation of the catheter does not result in the longitudinal scanning effect as in
TEE, but rather, the tip of the probe moves in a large 360degree arc. In practice, either the echo images can be followed and the probe manipulated to obtain the desired images, or the position of the probe tip can be monitored by fluoroscopy to obtain a standard probe position. By advancing the ICE catheter from the inferior vena cava with the control mechanism in a free or neutral position, the catheter is placed in the mid-right atrium, and a tricuspid valve inlet view is obtained by rotating the imaging palette of the catheter anteriorly and slightly leftward (Figure 2). The catheter tip is then rotated clockwise to visualize the aorta and left ventricular outflow tract (Figure 3). The lower atrial septum (cardiac crux) and mitral valve are then visualized by further clockwise catheter rotation (Figure 4). In some cases, with some rightward control movement there is posterior deflection of the catheter tip, and a classic 4-chamber view of the cardiac crux may be obtained as shown in Figure 4, D. With continued posterior (clockwise) rotation and cranial advancement of the catheter, a long-axis view of the atrial septum is obtained (Figure 5). In most cases, additional leftward and posterior or anterior control movement with resultant anterior deflection of the catheter tip is needed to optimize this image by moving the transducer tip back and away from the atrial septum. With further cranial and caudal positioning of the catheter and slight counterclockwise and clockwise rotation, the entire atrial septum is evaluated with 2-dimensional and color flow imaging. Usually the lipomatous superior margin of the atrial septum (septum secundum) is clearly rec-
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Figure 2. Left, Anteroposterior radiograph reveals the intracardiac echocardiographic catheter tip in the right atrium (arrow) with the transducer palette pointed toward the tricuspid valve. Middle, Lateral radiograph shows the corresponding lateral image with the transducer tip (arrow) pointed anteriorly. Right, Corresponding intracardiac echocardiographic image of the tricuspid valve and right ventricle (RV) with mild tricuspid insufficiency shown with color flow imaging. L = left; PA = pulmonary artery; RA = right atrium; S = superior.
ognized, as is the membrane of the fossa ovalis (Figure 6). A bubble contrast study with injection through the central venous catheter/sheath is then performed for documentation of the right-to-left shunt. From this same position, posterior imaging beyond the atrial septum allows visualization and evaluation of the left atrium and the left superior and inferior pulmonary veins as they course in front of the descending thoracic aorta (Figure 5). They are evaluated further by color flow imaging and pulsed wave Doppler interrogation. Continued clockwise rotation then allows subsequent evaluation of the right inferior pulmonary veins and subsequently the right superior pulmonary veins (Figure 7), ante-
rior and inferior to the right pulmonary artery. In some patients, visualization of the right pulmonary veins requires not only clockwise rotation but also slight posterior control movement (actually moves tip leftward). With slight counterclockwise rotation and further posterior control movement (anterior flexion) of the catheter tip, the superior vena cava is then evaluated (Figure 8). A short-axis image of the atrial septum and aortic root is then obtained with combined posterior and rightward control movement (actually moves tip of catheter anteriorly and laterally), then with some clockwise tip rotation, and by directing the tip anteriorly toward and sometimes across the tricuspid valve annulus (Figure 9).
Figure 3. Left, Anteroposterior radiograph shows the intracardiac echocardiographic catheter (arrow) now rotated slightly clockwise to point to the left ventricular (LV) outflow tract. Middle, Lateral image of the same catheter position (arrow). Right, Corresponding intracardiac echocardiographic image of the left ventricular outflow tract with color flow imaging. Ao = ascending aorta; L = left; MPA = main pulmonary artery; RA = right atrium; S = superior.
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Figure 4. Upper left, Anteroposterior radiograph shows the intracardiac echocardiographic catheter (arrow) further rotated clockwise to image the cardiac crux portion of the atrial septum above the mitral valve. Upper right, Lateral image of this catheter position (arrow). Lower left, Corresponding intracardiac echocardiographic image of the cardiac crux (arrow) just above the mitral valve and coronary sinus (CS). Lower right, Four-chamber view of the cardiac crux shows small right-to-left shunt across patent foramen ovale (arrow). I = inferior; L = left; LA = left atrium; LV = left ventricle; RA = right atrium; RV = right ventricle.
The catheter tip is then repositioned in the mid right atrium and, with the imaging palette facing the atrial septum, is manipulated with rightward and sometimes posterior control movement to move the catheter tip toward the atrial septum to cross it. With the catheter tip seated adjacent to the atrial septum or, in many cases, across the interatrial defect, the pulmonary veins are again evaluated. With even further anterior and rightward control movement (catheter flexion), an en face mitral inflow view is obtained (Figure 10). With the catheter across the atrial septum and rotated anteriorly (counterclockwise), a detailed short-axis view of the aortic valve is obtained, and with slight clockwise rotation of the catheter, the right ventricular outflow tract and pulmonary valve are observed (Figure 11). ASD/PFO Transcatheter Device Closure All patients received intravenous heparin, 50 to 100 IU/ kg (maximum, 8000 U) and antibiotic prophylaxis (cefo-
taxime, 35-50 mg/kg). After the initial ICE assessment, prograde right and left heart catheterization was performed through a 7F sheath in the contralateral femoral vein. Transcatheter closure was carried out using the previously described technique.2 Balloon sizing was performed and monitored with ICE and fluoroscopy. Usually the best images for clear measurement of balloon size were obtained with the long-axis view of the atrial septum (Figure 12). Multiple views of the inflated balloon and atrial septum with color flow imaging were obtained to show complete defect occlusion and to exclude other associated atrial defects. By fluoroscopy, the balloon size was obtained in both the anterior and lateral imaging planes (Figure 12). Once deployed but before release, the device was again imaged with ICE in both the long- and short-axis planes to determine appropriate device positioning in the atrial septum, to exclude the presence of additional defects, and to ensure that the device did not interfere with surrounding
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Figure 5. Upper left, Anteroposterior radiograph of the intracardiac echocardiographic (ICE) catheter (arrow) after further clockwise rotation and slight anterior and lateral retroflexion of the catheter reveals a long-axis ICE image of the atrial septum. Upper right, Lateral image of the catheter position (arrow) shows the slight anterior flexion of the catheter. Lower left, Corresponding ICE image of the long axis of the atrial septum (arrow) thus obtained. Lower right, Color flow image of left pulmonary venous return and a small left-to-right atrial shunt (arrow). A = anterior; DAo = descending aorta; LA = left atrium; LLPV = left lower pulmonary vein; LPA = left pulmonary artery; LUPV = left upper pulmonary vein; P = posterior; RA = right atrium; S = superior.
Figure 6. Left, Intracardiac echocardiographic long-axis image reveals a large patent foramen ovale (PFO) (10 mm) in a 25year-old patient with a previous stroke. Middle, Corresponding color flow image shows a large right-to-left shunt through the PFO (arrow). Right, The same long-axis image of the PFO with a large resting right-to-left shunt (arrow) shown with an inferior vena caval agitated saline injection. A = anterior; DAo = descending aorta; LA = left atrium; P = posterior; RA = right atrium; S = superior.
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Figure 7. Upper left, Anteroposterior radiograph reveals intracardiac echocardiographic (ICE) catheter tip position (arrow) after further clockwise catheter rotation to the right to image the right pulmonary veins. Upper right, Lateral radiograph shows catheter position (arrow). Lower left, Corresponding ICE image shows all 3 right pulmonary veins. Note that the right upper pulmonary vein (RUPV) courses anterior and then inferior to the right pulmonary artery (RPA). Lower right, With the catheter tip moved across the atrial defect, the ICE image then reveals a long-axis view of the RPA with the RUPV just inferior to the RPA. LA = left atrium; P = posterior; R = right; RLPV = right lower pulmonary vein; RMPV = right middle pulmonary vein; S = superior; SVC = superior vena cava.
Figure 8. Left, Left anterior oblique radiograh reveals anterior flexion of the catheter (arrow) to scan superiorly into the superior vena cava (SVC). A separate catheter has been placed across the atrial septal defect, and the tip lies in the left upper pulmonary vein. Middle, Lateral image of the same catheter position (arrow) scanning superiorly. Right, Corresponding intracardiac echocardiographic image shows flow from the SVC into the right atrium (RA). The right upper pulmonary vein (RUPV) is noted as it courses anterior (A) and inferior to the right pulmonary artery (RPA). S = superior.
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Figure 9. Left, Anteroposterior radiograph shows retroflexion of the catheter tip anteriorly and leftward and subsequent rotation of the catheter tip clockwise to place the tip (arrow) extremely near or through the tricuspid valve. Middle, Lateral image reveals the catheter position (arrow) near the tricuspid valve. Right, Corresponding intracardiac echocardiographic image reveals a typical short-axis image of the heart at the level of the aortic valve. A small left-to-right shunt (arrow) is observed through the superior margin of the atrial septal defect. The main pulmonary artery (MPA) is also noted posterior to the aorta. A = anterior; Ao = ascending aorta; L = left; LA = left atrium; RA = right atrium.
cardiac structures (Figure 13). Once the operator was satisfied with positioning, the device was then released. Twodimensional ICE imaging to determine stability, color flow imaging to determine the presence of residual shunts, and bubble contrast imaging to determine the presence of residual right-to-left shunt were then performed. Statistical Analyses All continuous variables are reported as mean ± SD, median, and range. Nominal variables were compared by χ2 test. Paired continuous variables were compared by a 2sided paired t test.
RESULTS Ninety-four patients (47 male; median age, 51 years [range, 17-81 years]; median weight, 79 kg [range, 39-179 kg]) underwent ICE and transcatheter device closure. Of the 94 patients, 77 (82%) had 1 defect (35 ASD, 42 PFO); 14 patients (15%) had 2 defects; and 3 (3%) had multifenestrated defects. Twenty-five patients (27%) had an atrial septal aneurysm and 7 (7%) had redundant atrial septum. The median ASD size by ICE was 13 mm (range, 8-32 mm). ICE was used to identify a previously unrecognized anatomical diagnosis in 32 (34%) of the 94 patients (Table 1).
Figure 10. Left, Anteroposterior radiograph shows the intracardiac echocardiographic catheter (arrow) advanced across the atrial septal defect and flexed inferiorly to obtain an en face view of the mitral valve orifice. Middle, Lateral radiograph reveals the same catheter position (arrow). Note the posterior location of the catheter in the left atrium. Right, Corresponding intracardiac echocardiographic image of the en face view of the mitral orifice. I = inferior; L = left; LA = left atrium; LV = left ventricle.
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Figure 11. Upper left, Anteroposterior radiograph of the intracardiac echocardiographic catheter tip (arrow) placed across the atrial septal defect into the left atrium but rotated counterclockwise to an anterior position immediately behind the aortic valve. Upper right, Lateral image of the same catheter position (arrow). Note that the transducer is pointing anteriorly. Lower left, Corresponding intracardiac echocardiographic image shows in the short axis the fine detail of the aortic valve leaflets. Lower right, With additional clockwise catheter rotation, a view of the right ventricular outflow tract and main pulmonary artery (MPA) is obtained. Arrow points to aortic valve and arrowhead points to pulmonary valve. A = anterior; Ao = ascending aorta; L = left; TV = tricuspid valve.
Figure 12. Left, Anteroposterior radiograph of the atrial septal defect sizing balloon inflated in the large patent foramen ovale (PFO) illustrated in Figure 5. Arrows indicate the 18.8-mm waist of the tunnel-like PFO. Middle, Lateral radiograph of the same balloon inflation with arrows indicating the PFO waist. Right, Long-axis intracardiac echocardiographic image of the atrial septum of the same patient. The balloonstretched PFO diameter was 1.81 cm. LA = left atrium.
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Figure 13. Upper left, Intracardiac echocardiographic image of the crux of the heart (arrow) reveals the Amplatzer atrial septal defect (ASD) occluder device (D) as it is being pulled toward the atrial septum. Upper right, Long-axis image of the ASD occluder in position in the atrial septum but still attached. The left atrial disks (arrows) are appropriately positioned. There is a small residual central left-to-right shunt. Lower left, Short-axis image of the ASD occluder position behind the aorta (Ao). The right and left atrial disks are appropriately positioned. Lower right, After release, a long-axis image still shows a small central left-to-right shunt (arrow). A = anterior; CS = coronary sinus; I = inferior; L = left; LA = left atrium; LV = left ventricle; P = posterior; RA = right atrium; S = superior.
Of these patients, 29 (91%) had undergone both TTE and TEE before referral for device closure. The most commonly unrecognized diagnosis was the presence of an additional ASD or PFO, found in 16 (50%) of the 32 patients. The second most common additional diagnosis detected by ICE was atrial septal aneurysm or redundant atrial septum, found in 12 (38%) of the 32 patients. An atrial septal aneurysm was defined as an atrial septum, or part of an atrial septum, that protruded at least 1.5 cm beyond the plane of the atrial septum. A redundant atrial septum was defined as an atrial septum, or part of an atrial septum, that clearly protruded beyond the plane of the septum but did not meet the criteria for an atrial septal aneurysm. One patient had anomalous drainage of the left upper pulmonary vein via a vertical vein to the innominate vein. One patient had a stenotic right upper pulmonary vein detected by Doppler imaging. Another patient had a large
right lower lobe pulmonary arteriovenous fistula identified at the time of contrast echocardiography. Finally, 1 patient had a prominent Chiari network, previously misinterpreted as showing multiple atrial septal fenestrations. For patients with ASDs and PFOs closed with an atrial septal occluder (Amplatzer, AGA Medical Corp, Golden Valley, Minn), the balloon-stretched diameters measured by ICE and fluoroscopy were not statistically different (P=.76 and P=.65, respectively). The median balloonstretched ASD diameter measured by ICE was 16.5 mm (range, 10-37 mm) and by fluoroscopy was 17 mm (range, 8-33 mm). The median balloon-stretched PFO diameter measured by ICE was 12.0 mm (range, 4-19 mm) and by fluoroscopy was 11.0 mm (range, 4-18 mm). ICE provided high-resolution 2-dimensional images in multiple longitudinal plane views and was used as the primary imaging tool in all patients to guide device place-
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ment and deployment. All patients underwent successful deployment and release of their devices, including 6 patients who had 2 devices released simultaneously. Overall, 79 patients received an Amplatzer septal occluder, 14 patients received an Amplatzer PFO occluder, and 1 patient received a CardioSEAL septal occluder (NMT Medical, Inc, Boston, Mass). Immediately after release of the device, 72 patients (77%) had trivial left-to-right shunt through the center of the device on color flow imaging. An additional 8 patients (9%) had trivial right-to-left shunt on contrast echocardiography. All 8 had undergone device closure of a PFO. Median fluoroscopy time was 30 minutes (range, 4115 minutes); median procedure time was 128 minutes (range, 27-320 minutes). The longest procedure time and fluoroscopy time occurred in the patient who had both closure of an ASD and embolization of a right lower lobe pulmonary arteriovenous fistula. There were few complications (4%) related to ICE. Three patients developed atrial fibrillation and 1 developed supraventricular tachycardia secondary to ICE manipulation. In 2 of the 4 (1 each with atrial fibrillation and supraventricular tachycardia), the tachycardia resolved spontaneously. Two patients with atrial fibrillation required electrical cardioversion at the end of the procedure. DISCUSSION TEE guidance during transcatheter device closure of ASD and PFO is now standard practice.1-7 Echocardiography is used to determine the size and location of the defect and its relationship to surrounding structures. However, TEE has limitations. Because it typically requires general anesthesia and endotracheal intubation, there is an increased risk for aspiration and the potential for airway obstruction. Also, TEE requires the use of additional echocardiographic personnel to perform the study. Several small studies have shown that ICE with the AcuNav catheter is a safe and effective imaging modality for the guidance of transcatheter device closure of ASD and PFO.10-12,14 However, no large series have been published to date, and experience with ICE remains relatively limited. Our series of 94 patients confirms both the efficacy and safety of ICE for the guidance of transcatheter device closure of ASD/PFO. In all 94 patients, ICE provided adequate, complete imaging, which allowed for successful device placement with extremely few complications. Overall, 100 devices were released in 94 patients. In addition, ICE provided accurate assessment of the atrial septum, position and size of the defects, adequacy of the rims, and drainage of the pulmonary veins in all patients. These findings are similar to the results reported by Hijazi et al,11 Mullen et al,12 and recently by Bartel et al.14 In the Mullen et al series, in which patients underwent both ICE and TEE, close agreement
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Table 1. Previously Unrecognized Diagnoses Detected by ICE During Transcatheter Device Closure* Patients with new diagnosis (N=94) Patients with new diagnosis who underwent TTE and TEE before referral Diagnoses Additional defect (ASD or PFO) Atrial septal aneurysm Redundant atrial septum PAPVR RUPV stenosis RLL pulmonary arteriovenous fistula Chiari network of the right atrium
32 (34) 29 (91) 16 (50) 9 (28) 3 (9) 1 (3) 1 (3) 1 (3) 1 (3)
*Values represent number (percentage) of patients. N = 32 unless indicated otherwise. ASD = atrial septal defect; ICE = intracardiac echocardiography; PAPVR = partial anomalous pulmonary venous return; PFO = patent foramen ovale; RLL = right lower lobe; RUPV = right upper pulmonary vein; TEE = transesophageal echocardiography; TTE = transthoracic echocardiography.
was found between ICE and TEE for assessing the number of defects, device position before release, and the presence of residual shunts in 23 patients who underwent transcatheter device closure of an ASD. However, a second small defect was identified in 1 patient by TEE but not by ICE. In our series, ICE accurately identified the referral diagnosis in 100% of the cases. In addition, ICE identified a previously unrecognized anatomical diagnosis in 32 (34%) of the patients. Of these 32 patients, 29 had undergone both TTE and TEE before referral. Additional diagnoses played a major role in the successful outcome of the procedure. In patients with 2 defects, a device large enough to cover both defects is required. If the second defect was too remote, a second device was placed simultaneously. With an atrial septal aneurysm, a device large enough to close the defect and entrap and stabilize most of the atrial septal aneurysm was chosen. In the patient with a Chiari network in the right atrium, it was important to distinguish the network from the true atrial septum and avoid device entrapment in the network during deployment.15 Finally, in the setting of previously unrecognized partial anomalous venous return, the need for surgical referral must be considered. In the patient in our series with partial anomalous pulmonary venous drainage, 3 right pulmonary veins were clearly defined entering the left atrium. However, only the left lower pulmonary vein could be identified entering the left atrium by ICE. This prompted further evaluation with angiography, confirming the diagnosis of anomalous drainage of the left upper pulmonary vein. This patient elected to have device closure of the ASD and later correction of the left veins via a left thoracotomy. As reported in previous series, ICE was associated with few complications in our series. The only associated complication was the development of atrial tachycardia during
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placement and manipulation of the ICE catheter within the right atrium, which occurred in 4% of the patients, similar to the incidence in prior reports.12 There were no vascular complications in our series or in the series reported by Hijazi et al.11 However, in the series by Mullen et al,12 1 patient experienced a persistent palsy of the ipsilateral lateral cutaneous nerve of the thigh. However, it is notable that all of the patients in our series were of adult size. Thus, the safety profile of ICE may change as it is used more frequently in younger and smaller patients. CONCLUSION In our series, ICE provided excellent anatomical detail of the ASD or PFO with regard to position and size, adequacy of rims, and relationship to surrounding cardiac structures. In addition, ICE imaging provided successful guidance during device placement in all 94 patients and was associated with few complications. Furthermore, it eliminated the major limitations associated with TEE, specifically the need for general anesthesia and the potential problems related to airway management. Finally, ICE gives the interventional cardiologist the ability to control all aspects of imaging during the procedure without additional echocardiographic support. We have provided a detailed stepwise approach for obtaining a complete intracardiac assessment of the cardiac anatomy during interventional catheterization procedures. We believe that ICE should be considered the preferred imaging technique for guidance of transcatheter device closure of ASD and PFO in adults and larger pediatric patients.
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Martin F, Sanchez PL, Doherty E, et al. Percutaneous transcatheter closure of patent foramen ovale in patients with paradoxical embolism. Circulation. 2002;106:1121-1126. Masura J, Gavora P, Formanek A, Hijazi ZM. Transcatheter closure of secundum atrial septal defects using the new self-centering Amplatzer septal occluder: initial human experience. Cathet Cardiovasc Diagn. 1997;42:388-393.
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Sievert H, Babic UU, Hausdorf G, et al. Transcatheter closure of atrial septal defect and patent foramen ovale with ASDOS device (a multi-institutional European trial). Am J Cardiol. 1998;82:14051413. Pedra CA, Pihkala J, Lee KJ, et al. Transcatheter closure of atrial septal defects using the Cardio-Seal implant. Heart. 2000;84:320326. Rao PS, Berger F, Rey C, et al, International Buttoned Device Trial Group. Results of transvenous occlusion of secundum atrial septal defects with the fourth generation buttoned device: comparison with first, second and third generation devices. J Am Coll Cardiol. 2000;36:583-592. Chan KC, Godman MJ, Walsh K, Wilson N, Redington A, Gibbs JL. Transcatheter closure of atrial septal defect and interatrial communications with a new self expanding nitinol double disc device (Amplatzer septal occluder): multicentre UK experience. Heart. 1999;82:300-306. Walsh KP, Wilmshurst PT, Morrison WL. Transcatheter closure of patent foramen ovale using the Amplatzer septal occluder to prevent recurrence of neurological decompression illness in divers. Heart. 1999;81:257-261. Hijazi ZM, Cao Q, Patel HT, Rhodes J, Hanlon KM. Transesophageal echocardiographic results of catheter closure of atrial septal defect in children and adults using the Amplatzer device. Am J Cardiol. 2000;85:1387-1390. O’Leary PW. Intracardiac echocardiography in congenital heart disease: are we ready to begin the fantastic voyage? Pediatr Cardiol. 2002;23:286-291. Bruce CJ, Nishimura RA, Rihal CS, et al. Intracardiac echocardiography in the interventional catheterization laboratory: preliminary experience with a novel, phased-array transducer. Am J Cardiol. 2002;89:635-640. Hijazi Z, Wang Z, Cao Q, Koenig P, Waight D, Lang R. Transcatheter closure of atrial septal defects and patent foramen ovale under intracardiac echocardiographic guidance: feasibility and comparison with transesophageal echocardiography. Catheter Cardiovasc Interv. 2001;52:194-199. Mullen MJ, Dias BF, Walker F, Siu SC, Benson LN, McLaughlin PR. Intracardiac echocardiography guided device closure of atrial septal defects. J Am Coll Cardiol. 2003;41:285-292. Packer DL, Stevens CL, Curley MG, et al. Intracardiac phased-array imaging: methods and initial clinical experience with high resolution, under blood visualization: initial experience with intracardiac phased-array ultrasound. J Am Coll Cardiol. 2002;39:509-516. Bartel T, Konorza T, Arjumand J, et al. Intracardiac echocardiography is superior to conventional monitoring for guiding device closure of interatrial communications. Circulation. 2003;107:795797. Onorato E, Pera IG, Melzi G, Rigatelli G. Persistent redundant Eustachian valve interfering with Amplatzer PFO occluder placement: anatomico-clinical and technical implications. Catheter Cardiovasc Interv. 2002;55:521-524.
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Original Article
Intracardiac Echocardiographic Guidance During Transcatheter Device Closure of Atrial Septal Defect and Patent Foramen Ovale MICHAEL G. EARING, MD; ALLISON K. CABALKA, MD; JAMES B. SEWARD, MD; CHARLES J. BRUCE, MD; GUY S. REEDER, MD; AND DONALD J. HAGLER, MD
• Objectives: To describe our experience with intracardiac echocardiographic (ICE) guidance during transcatheter device closure of atrial septal defect (ASD) and patent foramen ovale (PFO) and to describe a detailed stepwise approach for performing ICE examinations. • Patients and Methods: We reviewed the ICE results of all patients who underwent transcatheter device closure of ASD/PFO at the Mayo Clinic in Rochester, Minn, between October 2000 and November 2002. Conscious sedation was used, and all ICE studies were performed using a diagnostic ultrasound catheter. • Results: Ninety-four patients (47 male; median age, 51 years [range, 17-81 years]) underwent ICE during transcatheter device closure of ASD/PFO. Total procedure time was 128 minutes (range, 27-320 minutes). ICE identified a previously unrecognized anatomical diagnosis in 32 of 94 patients. An additional ASD or PFO was found in 16 patients; a redundant atrial septum or an atrial septal aneurysm was found in 12 patients. There were few ICE complications (4%): 3 patients developed atrial fibrillation,
and 1 developed supraventricular tachycardia; of these 4, 2 resolved spontaneously, and 2 required cardioversion with no recurrence. • Conclusion: ICE provides anatomical detail of ASD/ PFO and cardiac structures facilitating congenital cardiac interventional procedures. ICE eliminates major drawbacks related to the use of transesophageal echocardiographic guidance for transcatheter device closure of ASD/ PFO, specifically problems related to airway management. Finally, ICE gives the interventional cardiologist the ability to control all aspects of imaging without relying on additional echocardiographic support. We believe that ICE should be considered the preferred imaging technique for guidance of transcatheter device closure of ASD/PFO in adults and larger pediatric patients. Mayo Clin Proc. 2004;79:24-34 ASD = atrial septal defect; ICE = intracardiac echocardiography; PFO = patent foramen ovale; TEE = transesophageal echocardiography; TTE = transthoracic echocardiography
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catheter device closure of ASD and PFO is limited; therefore, we reviewed our experience with ICE guidance during attempted transcatheter device closure of ASD and PFO. The objectives of this study were to determine the safety and efficacy of ICE guidance during transcatheter device closure of ASD/PFO and to describe a detailed stepwise approach for performing the ICE examination.
ince first attempted by King and Mills in 1976, transcatheter device closure of atrial septal defect (ASD) and patent foramen ovale (PFO) has become an effective and safe alternative to surgery.1-7 Echocardiographic guidance during device closure of ASD and PFO is now standard practice. Transesophageal echocardiography (TEE) has been used most commonly but has associated limitations, specifically the need for general anesthesia and potential problems related to airway management in the supine patient.8,9 Recently, several small studies have shown that intracardiac echocardiography (ICE) using the AcuNav diagnostic ultrasound catheter (Acuson Corp, Mountain View, Calif) is a feasible and accurate alternative imaging modality for transcatheter device closure of ASD and PFO.10-13 Overall experience with ICE-guided trans-
For editorial comment, see page 15. PATIENTS AND METHODS Between October 2000 and November 2002, 94 patients underwent ICE during attempted transcatheter device closure of ASD/PFO at the Mayo Clinic in Rochester, Minn. Before referral, all patients had undergone transthoracic echocardiography (TTE), and 82 of the 94 patients had undergone TEE.
From the Division of Pediatric Cardiology (M.G.E., A.K.C., J.B.S., D.J.H.) and Division of Cardiovascular Diseases and Internal Medicine (A.K.C., J.B.S., C.J.B., G.S.R.), Mayo Clinic College of Medicine, Rochester, Minn.
Intracardiac Echocardiography Overview.—Femoral venous access (11F sheath) was obtained after administration of local anesthetic, concurrent with the use of conscious sedation. ICE studies were performed using the AcuNav diagnostic ultrasound cath-
Address reprint requests and correspondence to Donald J. Hagler, MD, Division of Pediatric Cardiology, Mayo Clinic College of Medicine, 200 First St SW, Rochester, MN 55905 (e-mail: hagler.donald @mayo.edu). Mayo Clin Proc. 2004;79:24-34
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© 2004 Mayo Foundation for Medical Education and Research
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Figure 1. A, Diagnostic ultrasound catheter (AcuNav) placed adjacent to a pediatric transesophageal echocardiography probe shows the relatively small size of the 10F catheter. B, Close-up of the 3.3-mm-diameter catheter tip (arrows) shows the longitudinally oriented crystal array (palette). C, Overhead view of the 4-way tip maneuverability of the diagnostic catheter.
eter linked to a Sequoia ultrasound-imaging platform (Acuson Corp). The AcuNav ultrasound catheter is a multifrequency (5.5-10.0 MHz), 64-element vector, phasedarray transducer mounted on a 3.3-mm (10F) catheter with a maneuverable 4-way tip (Figure 1) that is capable of high-resolution 2-dimensional and full Doppler imaging (pulsed, continuous-wave, and tissue Doppler). The longitudinal plane provides a 90-degree sector image with tissue penetration of 2 to 12 cm. The ICE catheter was advanced to the right atrium under fluoroscopic guidance. Image quality was optimized by adjusting gain, depth, frequency, and focal length controls. Complete ICE evaluation of the left and right sides of the heart was then performed. Detailed Description of ICE Examination.—Movements described relate to the manipulation of the control mechanisms on the handle of the ICE catheter. Movement of the control handle to the left of midline results in movement of the catheter tip to the left as visualized from the front of the probe handle. However, these movements may not result in movement of the catheter tip in the same direction as illustrated outside of the body because during an examination, the imaging palette is also being rotated in various directions to achieve a particular image plane. Thus, if the probe is oriented to visualize a posterior structure (palette-directed posterior), posterior manipulation of the probe handle controls results in a more anterior position (anterior flexion) of the catheter tip. When the catheter is angulated into unusual positions, such as the position required to achieve a short-axis image plane (posterior and rightward control movement), simple rotation of the catheter does not result in the longitudinal scanning effect as in
TEE, but rather, the tip of the probe moves in a large 360degree arc. In practice, either the echo images can be followed and the probe manipulated to obtain the desired images, or the position of the probe tip can be monitored by fluoroscopy to obtain a standard probe position. By advancing the ICE catheter from the inferior vena cava with the control mechanism in a free or neutral position, the catheter is placed in the mid-right atrium, and a tricuspid valve inlet view is obtained by rotating the imaging palette of the catheter anteriorly and slightly leftward (Figure 2). The catheter tip is then rotated clockwise to visualize the aorta and left ventricular outflow tract (Figure 3). The lower atrial septum (cardiac crux) and mitral valve are then visualized by further clockwise catheter rotation (Figure 4). In some cases, with some rightward control movement there is posterior deflection of the catheter tip, and a classic 4-chamber view of the cardiac crux may be obtained as shown in Figure 4, D. With continued posterior (clockwise) rotation and cranial advancement of the catheter, a long-axis view of the atrial septum is obtained (Figure 5). In most cases, additional leftward and posterior or anterior control movement with resultant anterior deflection of the catheter tip is needed to optimize this image by moving the transducer tip back and away from the atrial septum. With further cranial and caudal positioning of the catheter and slight counterclockwise and clockwise rotation, the entire atrial septum is evaluated with 2-dimensional and color flow imaging. Usually the lipomatous superior margin of the atrial septum (septum secundum) is clearly rec-
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Figure 2. Left, Anteroposterior radiograph reveals the intracardiac echocardiographic catheter tip in the right atrium (arrow) with the transducer palette pointed toward the tricuspid valve. Middle, Lateral radiograph shows the corresponding lateral image with the transducer tip (arrow) pointed anteriorly. Right, Corresponding intracardiac echocardiographic image of the tricuspid valve and right ventricle (RV) with mild tricuspid insufficiency shown with color flow imaging. L = left; PA = pulmonary artery; RA = right atrium; S = superior.
ognized, as is the membrane of the fossa ovalis (Figure 6). A bubble contrast study with injection through the central venous catheter/sheath is then performed for documentation of the right-to-left shunt. From this same position, posterior imaging beyond the atrial septum allows visualization and evaluation of the left atrium and the left superior and inferior pulmonary veins as they course in front of the descending thoracic aorta (Figure 5). They are evaluated further by color flow imaging and pulsed wave Doppler interrogation. Continued clockwise rotation then allows subsequent evaluation of the right inferior pulmonary veins and subsequently the right superior pulmonary veins (Figure 7), ante-
rior and inferior to the right pulmonary artery. In some patients, visualization of the right pulmonary veins requires not only clockwise rotation but also slight posterior control movement (actually moves tip leftward). With slight counterclockwise rotation and further posterior control movement (anterior flexion) of the catheter tip, the superior vena cava is then evaluated (Figure 8). A short-axis image of the atrial septum and aortic root is then obtained with combined posterior and rightward control movement (actually moves tip of catheter anteriorly and laterally), then with some clockwise tip rotation, and by directing the tip anteriorly toward and sometimes across the tricuspid valve annulus (Figure 9).
Figure 3. Left, Anteroposterior radiograph shows the intracardiac echocardiographic catheter (arrow) now rotated slightly clockwise to point to the left ventricular (LV) outflow tract. Middle, Lateral image of the same catheter position (arrow). Right, Corresponding intracardiac echocardiographic image of the left ventricular outflow tract with color flow imaging. Ao = ascending aorta; L = left; MPA = main pulmonary artery; RA = right atrium; S = superior.
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Figure 4. Upper left, Anteroposterior radiograph shows the intracardiac echocardiographic catheter (arrow) further rotated clockwise to image the cardiac crux portion of the atrial septum above the mitral valve. Upper right, Lateral image of this catheter position (arrow). Lower left, Corresponding intracardiac echocardiographic image of the cardiac crux (arrow) just above the mitral valve and coronary sinus (CS). Lower right, Four-chamber view of the cardiac crux shows small right-to-left shunt across patent foramen ovale (arrow). I = inferior; L = left; LA = left atrium; LV = left ventricle; RA = right atrium; RV = right ventricle.
The catheter tip is then repositioned in the mid right atrium and, with the imaging palette facing the atrial septum, is manipulated with rightward and sometimes posterior control movement to move the catheter tip toward the atrial septum to cross it. With the catheter tip seated adjacent to the atrial septum or, in many cases, across the interatrial defect, the pulmonary veins are again evaluated. With even further anterior and rightward control movement (catheter flexion), an en face mitral inflow view is obtained (Figure 10). With the catheter across the atrial septum and rotated anteriorly (counterclockwise), a detailed short-axis view of the aortic valve is obtained, and with slight clockwise rotation of the catheter, the right ventricular outflow tract and pulmonary valve are observed (Figure 11). ASD/PFO Transcatheter Device Closure All patients received intravenous heparin, 50 to 100 IU/ kg (maximum, 8000 U) and antibiotic prophylaxis (cefo-
taxime, 35-50 mg/kg). After the initial ICE assessment, prograde right and left heart catheterization was performed through a 7F sheath in the contralateral femoral vein. Transcatheter closure was carried out using the previously described technique.2 Balloon sizing was performed and monitored with ICE and fluoroscopy. Usually the best images for clear measurement of balloon size were obtained with the long-axis view of the atrial septum (Figure 12). Multiple views of the inflated balloon and atrial septum with color flow imaging were obtained to show complete defect occlusion and to exclude other associated atrial defects. By fluoroscopy, the balloon size was obtained in both the anterior and lateral imaging planes (Figure 12). Once deployed but before release, the device was again imaged with ICE in both the long- and short-axis planes to determine appropriate device positioning in the atrial septum, to exclude the presence of additional defects, and to ensure that the device did not interfere with surrounding
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Figure 5. Upper left, Anteroposterior radiograph of the intracardiac echocardiographic (ICE) catheter (arrow) after further clockwise rotation and slight anterior and lateral retroflexion of the catheter reveals a long-axis ICE image of the atrial septum. Upper right, Lateral image of the catheter position (arrow) shows the slight anterior flexion of the catheter. Lower left, Corresponding ICE image of the long axis of the atrial septum (arrow) thus obtained. Lower right, Color flow image of left pulmonary venous return and a small left-to-right atrial shunt (arrow). A = anterior; DAo = descending aorta; LA = left atrium; LLPV = left lower pulmonary vein; LPA = left pulmonary artery; LUPV = left upper pulmonary vein; P = posterior; RA = right atrium; S = superior.
Figure 6. Left, Intracardiac echocardiographic long-axis image reveals a large patent foramen ovale (PFO) (10 mm) in a 25year-old patient with a previous stroke. Middle, Corresponding color flow image shows a large right-to-left shunt through the PFO (arrow). Right, The same long-axis image of the PFO with a large resting right-to-left shunt (arrow) shown with an inferior vena caval agitated saline injection. A = anterior; DAo = descending aorta; LA = left atrium; P = posterior; RA = right atrium; S = superior.
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Figure 7. Upper left, Anteroposterior radiograph reveals intracardiac echocardiographic (ICE) catheter tip position (arrow) after further clockwise catheter rotation to the right to image the right pulmonary veins. Upper right, Lateral radiograph shows catheter position (arrow). Lower left, Corresponding ICE image shows all 3 right pulmonary veins. Note that the right upper pulmonary vein (RUPV) courses anterior and then inferior to the right pulmonary artery (RPA). Lower right, With the catheter tip moved across the atrial defect, the ICE image then reveals a long-axis view of the RPA with the RUPV just inferior to the RPA. LA = left atrium; P = posterior; R = right; RLPV = right lower pulmonary vein; RMPV = right middle pulmonary vein; S = superior; SVC = superior vena cava.
Figure 8. Left, Left anterior oblique radiograh reveals anterior flexion of the catheter (arrow) to scan superiorly into the superior vena cava (SVC). A separate catheter has been placed across the atrial septal defect, and the tip lies in the left upper pulmonary vein. Middle, Lateral image of the same catheter position (arrow) scanning superiorly. Right, Corresponding intracardiac echocardiographic image shows flow from the SVC into the right atrium (RA). The right upper pulmonary vein (RUPV) is noted as it courses anterior (A) and inferior to the right pulmonary artery (RPA). S = superior.
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Figure 9. Left, Anteroposterior radiograph shows retroflexion of the catheter tip anteriorly and leftward and subsequent rotation of the catheter tip clockwise to place the tip (arrow) extremely near or through the tricuspid valve. Middle, Lateral image reveals the catheter position (arrow) near the tricuspid valve. Right, Corresponding intracardiac echocardiographic image reveals a typical short-axis image of the heart at the level of the aortic valve. A small left-to-right shunt (arrow) is observed through the superior margin of the atrial septal defect. The main pulmonary artery (MPA) is also noted posterior to the aorta. A = anterior; Ao = ascending aorta; L = left; LA = left atrium; RA = right atrium.
cardiac structures (Figure 13). Once the operator was satisfied with positioning, the device was then released. Twodimensional ICE imaging to determine stability, color flow imaging to determine the presence of residual shunts, and bubble contrast imaging to determine the presence of residual right-to-left shunt were then performed. Statistical Analyses All continuous variables are reported as mean ± SD, median, and range. Nominal variables were compared by χ2 test. Paired continuous variables were compared by a 2sided paired t test.
RESULTS Ninety-four patients (47 male; median age, 51 years [range, 17-81 years]; median weight, 79 kg [range, 39-179 kg]) underwent ICE and transcatheter device closure. Of the 94 patients, 77 (82%) had 1 defect (35 ASD, 42 PFO); 14 patients (15%) had 2 defects; and 3 (3%) had multifenestrated defects. Twenty-five patients (27%) had an atrial septal aneurysm and 7 (7%) had redundant atrial septum. The median ASD size by ICE was 13 mm (range, 8-32 mm). ICE was used to identify a previously unrecognized anatomical diagnosis in 32 (34%) of the 94 patients (Table 1).
Figure 10. Left, Anteroposterior radiograph shows the intracardiac echocardiographic catheter (arrow) advanced across the atrial septal defect and flexed inferiorly to obtain an en face view of the mitral valve orifice. Middle, Lateral radiograph reveals the same catheter position (arrow). Note the posterior location of the catheter in the left atrium. Right, Corresponding intracardiac echocardiographic image of the en face view of the mitral orifice. I = inferior; L = left; LA = left atrium; LV = left ventricle.
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Figure 11. Upper left, Anteroposterior radiograph of the intracardiac echocardiographic catheter tip (arrow) placed across the atrial septal defect into the left atrium but rotated counterclockwise to an anterior position immediately behind the aortic valve. Upper right, Lateral image of the same catheter position (arrow). Note that the transducer is pointing anteriorly. Lower left, Corresponding intracardiac echocardiographic image shows in the short axis the fine detail of the aortic valve leaflets. Lower right, With additional clockwise catheter rotation, a view of the right ventricular outflow tract and main pulmonary artery (MPA) is obtained. Arrow points to aortic valve and arrowhead points to pulmonary valve. A = anterior; Ao = ascending aorta; L = left; TV = tricuspid valve.
Figure 12. Left, Anteroposterior radiograph of the atrial septal defect sizing balloon inflated in the large patent foramen ovale (PFO) illustrated in Figure 5. Arrows indicate the 18.8-mm waist of the tunnel-like PFO. Middle, Lateral radiograph of the same balloon inflation with arrows indicating the PFO waist. Right, Long-axis intracardiac echocardiographic image of the atrial septum of the same patient. The balloonstretched PFO diameter was 1.81 cm. LA = left atrium.
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Figure 13. Upper left, Intracardiac echocardiographic image of the crux of the heart (arrow) reveals the Amplatzer atrial septal defect (ASD) occluder device (D) as it is being pulled toward the atrial septum. Upper right, Long-axis image of the ASD occluder in position in the atrial septum but still attached. The left atrial disks (arrows) are appropriately positioned. There is a small residual central left-to-right shunt. Lower left, Short-axis image of the ASD occluder position behind the aorta (Ao). The right and left atrial disks are appropriately positioned. Lower right, After release, a long-axis image still shows a small central left-to-right shunt (arrow). A = anterior; CS = coronary sinus; I = inferior; L = left; LA = left atrium; LV = left ventricle; P = posterior; RA = right atrium; S = superior.
Of these patients, 29 (91%) had undergone both TTE and TEE before referral for device closure. The most commonly unrecognized diagnosis was the presence of an additional ASD or PFO, found in 16 (50%) of the 32 patients. The second most common additional diagnosis detected by ICE was atrial septal aneurysm or redundant atrial septum, found in 12 (38%) of the 32 patients. An atrial septal aneurysm was defined as an atrial septum, or part of an atrial septum, that protruded at least 1.5 cm beyond the plane of the atrial septum. A redundant atrial septum was defined as an atrial septum, or part of an atrial septum, that clearly protruded beyond the plane of the septum but did not meet the criteria for an atrial septal aneurysm. One patient had anomalous drainage of the left upper pulmonary vein via a vertical vein to the innominate vein. One patient had a stenotic right upper pulmonary vein detected by Doppler imaging. Another patient had a large
right lower lobe pulmonary arteriovenous fistula identified at the time of contrast echocardiography. Finally, 1 patient had a prominent Chiari network, previously misinterpreted as showing multiple atrial septal fenestrations. For patients with ASDs and PFOs closed with an atrial septal occluder (Amplatzer, AGA Medical Corp, Golden Valley, Minn), the balloon-stretched diameters measured by ICE and fluoroscopy were not statistically different (P=.76 and P=.65, respectively). The median balloonstretched ASD diameter measured by ICE was 16.5 mm (range, 10-37 mm) and by fluoroscopy was 17 mm (range, 8-33 mm). The median balloon-stretched PFO diameter measured by ICE was 12.0 mm (range, 4-19 mm) and by fluoroscopy was 11.0 mm (range, 4-18 mm). ICE provided high-resolution 2-dimensional images in multiple longitudinal plane views and was used as the primary imaging tool in all patients to guide device place-
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ment and deployment. All patients underwent successful deployment and release of their devices, including 6 patients who had 2 devices released simultaneously. Overall, 79 patients received an Amplatzer septal occluder, 14 patients received an Amplatzer PFO occluder, and 1 patient received a CardioSEAL septal occluder (NMT Medical, Inc, Boston, Mass). Immediately after release of the device, 72 patients (77%) had trivial left-to-right shunt through the center of the device on color flow imaging. An additional 8 patients (9%) had trivial right-to-left shunt on contrast echocardiography. All 8 had undergone device closure of a PFO. Median fluoroscopy time was 30 minutes (range, 4115 minutes); median procedure time was 128 minutes (range, 27-320 minutes). The longest procedure time and fluoroscopy time occurred in the patient who had both closure of an ASD and embolization of a right lower lobe pulmonary arteriovenous fistula. There were few complications (4%) related to ICE. Three patients developed atrial fibrillation and 1 developed supraventricular tachycardia secondary to ICE manipulation. In 2 of the 4 (1 each with atrial fibrillation and supraventricular tachycardia), the tachycardia resolved spontaneously. Two patients with atrial fibrillation required electrical cardioversion at the end of the procedure. DISCUSSION TEE guidance during transcatheter device closure of ASD and PFO is now standard practice.1-7 Echocardiography is used to determine the size and location of the defect and its relationship to surrounding structures. However, TEE has limitations. Because it typically requires general anesthesia and endotracheal intubation, there is an increased risk for aspiration and the potential for airway obstruction. Also, TEE requires the use of additional echocardiographic personnel to perform the study. Several small studies have shown that ICE with the AcuNav catheter is a safe and effective imaging modality for the guidance of transcatheter device closure of ASD and PFO.10-12,14 However, no large series have been published to date, and experience with ICE remains relatively limited. Our series of 94 patients confirms both the efficacy and safety of ICE for the guidance of transcatheter device closure of ASD/PFO. In all 94 patients, ICE provided adequate, complete imaging, which allowed for successful device placement with extremely few complications. Overall, 100 devices were released in 94 patients. In addition, ICE provided accurate assessment of the atrial septum, position and size of the defects, adequacy of the rims, and drainage of the pulmonary veins in all patients. These findings are similar to the results reported by Hijazi et al,11 Mullen et al,12 and recently by Bartel et al.14 In the Mullen et al series, in which patients underwent both ICE and TEE, close agreement
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Table 1. Previously Unrecognized Diagnoses Detected by ICE During Transcatheter Device Closure* Patients with new diagnosis (N=94) Patients with new diagnosis who underwent TTE and TEE before referral Diagnoses Additional defect (ASD or PFO) Atrial septal aneurysm Redundant atrial septum PAPVR RUPV stenosis RLL pulmonary arteriovenous fistula Chiari network of the right atrium
32 (34) 29 (91) 16 (50) 9 (28) 3 (9) 1 (3) 1 (3) 1 (3) 1 (3)
*Values represent number (percentage) of patients. N = 32 unless indicated otherwise. ASD = atrial septal defect; ICE = intracardiac echocardiography; PAPVR = partial anomalous pulmonary venous return; PFO = patent foramen ovale; RLL = right lower lobe; RUPV = right upper pulmonary vein; TEE = transesophageal echocardiography; TTE = transthoracic echocardiography.
was found between ICE and TEE for assessing the number of defects, device position before release, and the presence of residual shunts in 23 patients who underwent transcatheter device closure of an ASD. However, a second small defect was identified in 1 patient by TEE but not by ICE. In our series, ICE accurately identified the referral diagnosis in 100% of the cases. In addition, ICE identified a previously unrecognized anatomical diagnosis in 32 (34%) of the patients. Of these 32 patients, 29 had undergone both TTE and TEE before referral. Additional diagnoses played a major role in the successful outcome of the procedure. In patients with 2 defects, a device large enough to cover both defects is required. If the second defect was too remote, a second device was placed simultaneously. With an atrial septal aneurysm, a device large enough to close the defect and entrap and stabilize most of the atrial septal aneurysm was chosen. In the patient with a Chiari network in the right atrium, it was important to distinguish the network from the true atrial septum and avoid device entrapment in the network during deployment.15 Finally, in the setting of previously unrecognized partial anomalous venous return, the need for surgical referral must be considered. In the patient in our series with partial anomalous pulmonary venous drainage, 3 right pulmonary veins were clearly defined entering the left atrium. However, only the left lower pulmonary vein could be identified entering the left atrium by ICE. This prompted further evaluation with angiography, confirming the diagnosis of anomalous drainage of the left upper pulmonary vein. This patient elected to have device closure of the ASD and later correction of the left veins via a left thoracotomy. As reported in previous series, ICE was associated with few complications in our series. The only associated complication was the development of atrial tachycardia during
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placement and manipulation of the ICE catheter within the right atrium, which occurred in 4% of the patients, similar to the incidence in prior reports.12 There were no vascular complications in our series or in the series reported by Hijazi et al.11 However, in the series by Mullen et al,12 1 patient experienced a persistent palsy of the ipsilateral lateral cutaneous nerve of the thigh. However, it is notable that all of the patients in our series were of adult size. Thus, the safety profile of ICE may change as it is used more frequently in younger and smaller patients. CONCLUSION In our series, ICE provided excellent anatomical detail of the ASD or PFO with regard to position and size, adequacy of rims, and relationship to surrounding cardiac structures. In addition, ICE imaging provided successful guidance during device placement in all 94 patients and was associated with few complications. Furthermore, it eliminated the major limitations associated with TEE, specifically the need for general anesthesia and the potential problems related to airway management. Finally, ICE gives the interventional cardiologist the ability to control all aspects of imaging during the procedure without additional echocardiographic support. We have provided a detailed stepwise approach for obtaining a complete intracardiac assessment of the cardiac anatomy during interventional catheterization procedures. We believe that ICE should be considered the preferred imaging technique for guidance of transcatheter device closure of ASD and PFO in adults and larger pediatric patients.
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