© 2013, Wiley Periodicals, Inc. DOI: 10.1111/echo.12106
Echocardiography
RESEARCH FROM THE UNIVERSITY OF ALABAMA AT BIRMINGHAM
Live/Real Time Three-Dimensional Transesophageal Echocardiography in Percutaneous Closure of Atrial Septal Defects Maneesha Bhaya, M.D.,* Ferit Onur Mutluer, M.D.,* Edward Mahan, M.D.,* Luke Mahan,* Ming C. Hsiung, M.D.,† Wei–Hsian Yin, M.D., Ph.D.,† Jeng Wei, M.D., MsD,† Shen–Kou Tsai, M.D., Ph.D.,† Guang–Yu Zhao, M.D.,† Wei–Hsian Yin, M.D.,‡ Manish Pradhan, M.D.,* Rajesh Beniwal, M.D.,§ Deepak Joshi, M.D.,* Fatemeh Nabavizadeh, M.D.,* Amitoj Singh, M.B.B.S.,* and Navin C. Nanda, M.D.* *Division of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham, Alabama; †Heart Center, Division of Cardiology, Cheng Hsin General Hospital, Taipei, Taiwan; ‡Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan; and §S.S.R. Medical College, Belle Rive, Mauritius
Objectives: This study assessed the ability of live/real time three-dimensional transesophageal echocardiography (3DTEE) in measuring (1) atrial septal defect (ASD) maximum dimension, area, and adjacent rim size, (2) ASD occluder left and right atrial disk size, (3) length of contact between the left atrial (LA) disk and the aorta, and in (4) assessing device related complications such as residual shunt, device embolization, and device encroachment upon adjacent cardiac structures. Materials and Methods: 3DTEE images acquired during percutaneous ASD closure by the Amplatzer Septal Occluder in 15 adult patients were retrospectively analyzed. Offline analysis was done using both the Philips 5500 ultrasound system and Philips QLAB software. 3D color flow Doppler images were used to assess residual ASD shunting. Results: The Philips 5500 and Philips QLAB measurements correlated well for ASD maximum dimension and area measurements. The Philips QLAB 3DTEE disk size measurements also correlated well with the manufacturer obtained sizes. The aortic rim was deficient in 7 of the 15 patients, and the mean ASD occluder device size was 4 mm greater than the mean ASD maximum dimension. The LA occluder disk was in contact with the aorta throughout the cardiac cycle in 12 of the 15 patients, and the LA occluder disk size correlated significantly with the contact length with the aorta. Conclusion: Most of the patients demonstrated contact between the LA occluder disk and the aorta throughout the cardiac cycle. 3DTEE may be useful in identifying patients at greater risk for aortic erosion. (Echocardiography 2013;30:345-353) Key words: atrial septal defect in adults, two-dimensional transesophageal echocardiography, live/real time three-dimensional transesophageal echocardiography, percutaneous closure of atrial septal defect, aortic erosion by atrial septal defect closure device Percutaneous transvenous closure of secundum atrial septal defects (ASDs) was first successfully performed in 1974,1 but only in recent years, the technique has become widespread. It is considered a safe procedure with reported complication rates from 6 to 11%.2,3 The Amplatzer Septal Occluder (ASO) is the most commonly used closure device.4 Two-dimensional transesophageal echocardiography (2DTEE) provides superior images of the interatrial septum compared with two-dimenDr. Maneesha Bhaya and Dr. Ferit Onur Mutluer worked equally on the paper and are to be considered first authors. Address for correspondence and reprint requests: Navin C. Nanda, M.D., University of Alabama at Birmingham, Echo Lab SW/S102, 619 19th Street South, Birmingham, AL 35249. Fax: (205)-934-6747; E-mail:
[email protected]
sional transthoracic echocardiography (2DTTE).5–7 2DTEE is recommended by the American Society of Echocardiography (ASE) for percutaneous ASD closure guidance and has been validated for the measurement of ASD maximum dimension and adjacent septal rims.6,8–11 2DTEE remains the most commonly used imaging modality worldwide for obtaining these measurements. Accurate measurement of ASD maximum dimension and septal rim size is essential in selecting the correct occluder device size. Under sizing the device may lead to a residual shunt or device embolization and oversizing may lead to a residual shunt, impingement on adjacent cardiac structures, device erosion, or cardiac perforation.2,3,12 2DTEE has limitations in assessing ASD dimensions and adjacent rim size. It generates thin slice 345
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views that are very user dependent in obtaining optimum imaging positions and angles to properly visualize the ASD while maintaining a mental three-dimensional reconstruction of the image which may preclude comprehensive periprocedural and postprocedural ASD assessment.13 3DTEE has the potential to circumvent the limitations of 2DTEE. 3DTEE generates unique en face ASD images allowing (1) reliable measurements of the ASD maximum dimension and area and (2) en face imaging of the implanted device. The occluder left atrial (LA) and right atrial (RA) disk position and size can then be accurately assessed.14 3DTEE can be easily performed in the catheterization laboratory unlike 3DTTE, magnetic resonance imaging, and computerized tomography. Intracardiac echocardiography requires an additional intravenous line and has the same limitations inherent in 2DTTE. Fluoroscopic balloon sizing produces only 2D images, increases procedure time, and does not allow visualization of the ASD rim. There are reports of the utility of 3D transesophageal echocardiographic reconstruction in measuring the ASD maximum dimension and rim size and of LA disks causing indentation of the aorta.15–18 No study has evaluated 3DTEE in (1) measuring the length of contact (mm) between the LA disk and aorta after device deployment or (2) measurement of the LA and RA occluder disk diameters. These parameters are especially relevant in view of recent reports of aortic erosion by the ASO device.19,20 We therefore retrospectively analyzed 3DTEE images in 15 patients who underwent percutaneous device closure of secundum ASDs. The purpose of this study was to assess the ability of 3DTEE in measuring (1) ASD maximum dimension and area, (2) adjacent ASD rim size, (3) LA and RA occluder disk diameters, (4) length of contact (mm) between LA disk and the aorta, and (5) assessment of device-related complications such as residual shunt, device embolization, and device encroachment on adjacent cardiac structures. Material and Methods: The study group included 15 adult patients diagnosed with a secundum ASD by 2DTTE and 2DTEE. There were 13 females and 2 males ranging in age from 17 to 73 years (mean 41.4 years). Fourteen of the 15 patients had a single defect and 1 patient had multiple ASDs (4 large and several small fenestrated ASDs). One patient with a single septal defect also had a large interatrial septal aneurysm. Patients were studied by 2DTEE and 3DTEE before, during and after the occluder device placement, although preprocedure 2D- and 3DTEE images were not 346
available in 1 patient. Preprocedural 2DTEE and 3DTEE color Doppler flow images were available in 14 patients and 1 patient, respectively. Postprocedural 2DTEE and 3DTEE color Doppler flow images were available in only 1 patient. A Philips IE-33 ultrasound system (Andover, MA, USA) with a 2DTEE 2–7 MHz transducer and a 3DTEE 97-2t transducer was used in all patients and 3D images were obtained as described previously from our laboratory.21 All patients received an ASO (AGA Medical Corp., Golden Valley, MN, USA) device and the patient with multiple septal defects received 2 devices (1 ASO and 1 Amplatzer Septal Fenestrated Occluder). The 2DTEE ASD maximum dimension using multiple planes and confirmed by shunt visualization by color Doppler were measured. Sizing balloons were used in 2 patients. The operator(s) based device size selection on 2DTEE measurements and the availability of devices in the laboratory at the time of ASD closure. Dimensions were remeasured retrospectively. Measurement of the ASD Area and Maximum Dimension: B-Mode 3D datasets were cropped to view the ASD en face from the left atrium (Fig. 1, movie clip 1), transferred to a Philips 5500 ultrasound system and then measured in the non-multiplanar rendering (MPR) mode as described previously.15,22 The dataset with the clearest en face ASD view from the LA aspect was again selected for analysis using the MPR mode of the Philips Q-Lab 7.0 software as described in previous studies.13,23 Three orthogonal planes (postero-anterior/green, lateral/red, and transverse/blue) occupied 3 display screen quadrants and the fourth or lower right quadrant contained the cropped, non-MPR (full volume) en face ASD view. Either the postero-anterior or the lateral plane was aligned parallel to the long axis of the defect in the non-MPR mode and then adjusted to view the maximum inner dimension of the defect in the cardiac cycle using images with minimal signal dropout. The transverse plane was aligned parallel to the maximum dimension of the ASD in the MPR mode and the en face image of the ASD was visualized in the corresponding window. The ASD area was measured by planimetry avoiding tissue dropout. Measurement of the Septal Rims: The 3D full-volume datasets were cropped to identify the aortic valve and aorta utilizing the clearest images. The aortic rim was the minimum distance from the inner edge of the ASD to the aortic outer wall and was assessed using the Philips 5500 system non-MPR mode because the Q-LAB MPR mode did not clearly display the
3DTEE in ASD Closure
Figure 1. Live/real time three-dimensional transesophageal echocardiography (Case #14). Full-volume image. Arrowhead points to a large atrial septal defect. The aortic (AO) rim, shown by asterisks, measured 2 mm, the inferior vena cava (IVC) rim 11.6 mm and the superior vena cava (SVC) rim 8.8 mm. RA = right atrium. (movie clip 1).
aortic rim due to image signal dropout. Septal rims 0.99, P < 0.05, respectively. The kappa value for inter-observer variability was 0.97; (b) aortic rim: r 99, P < 0.05 and r = 0.94, P < 0.05, respectively. The kappa value for inter-observer variability was 0.87; (c) SVC rim: r > 0.99, P < 0.05 and r = 0.63, P < 0.05, respectively. The kappa value for inter-observer variability was 0.58; (d) LA disk: r > 0.99, P < 0.05 and r = 0.98, P < 0.05, respectively. The kappa value for inter-observer variability was 0.93 (e) RA disk: r > 0.99, P < 0.05 and r = 0.97, P < 0.05, respectively. The kappa value for inter-observer variability was 0.87, respectively, (f) contact length between the LA disk and aorta: r > 0.99, P < 0.05 and r = 0.88, P < 0.05, respectively. The kappa value for inter-observer variability was 0.80.
Discussion: The mathematical mean of ASD maximum dimensions measured by 3DTEE and 2DTEE was not statistically different in our study which is similar to previous studies.13,25 However, when individual cases were considered, the differences ranged from 5 to +13 mm which could lead to a wide variation in device size selection. Although most authorities recommend use of a device within 2 mm of the stretched balloon diameter,15,26,27 in our study the mean size of the implanted device was 4 mm greater than the mean maximum dimension of the ASD measured by 3DTEE using the QLAB MPR mode. This oversizing may be partly attributed to the device size availability at the time of the procedure. For example, if the ASD size was 21 mm which would require a 23 mm occluder and if it was not available a 25 mm device would be used. This would explain the higher correlation obtained between the ASD maximum dimension and the device waist diameters (which are both linear dimensions) compared with the ASD area and device waist area (squared linear values). This oversizing mismatch of device size would be expected to be mathematically amplified by using the squared linear values and thus decrease the area correlation values. The 3DTEE LA and RA disk diameters correlated well with manufacturer obtained measurements, substantiating the abil351
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ity of 3DTEE technology to obtain precise measurements. The ASD area and maximum dimensions measured using the thin slice QLAB MPR mode and the thicker slice Philips 5500 ultrasound system correlated well. However, echo signal dropout was problematic with the QLAB MPR mode and precluded measurement of the ASD area in 2 patients, including the patient with multiple defects. Similarly, aortic rims could not be measured using the QLAB MPR mode because of tissue signal dropout and were measured using thicker slices and the Philips 5500 ultrasound system. In contrast, SVC rims could be reliably measured using the QLAB MPR mode because of minimal tissue signal dropouts in the 3D datasets obtained by us. Our findings highlight the limitation of QLAB MPR mode due to its thin sampling slices and subsequent inability to reliably measure curvilinear structures. Atrial septal defect rims of at least 5 mm are generally considered adequate for device closure. ASD rims less than 5 mm are considered deficient and may not be suitable for device closure.17,25 However, some operators consider it safe to deploy devices in patients with small aortic rims10,28; therefore, accurate rim size is critical. The Food and Drug Administration (FDA) premarket clinical trials of the ASO device found that complications such as residual shunting or device embolization were minimized when the selected device size was 1–2 mm greater than the 2DTEE and balloon-sized ASD maximum dimension.12 Some operators prefer to oversize the occluder device by 3–4 mm especially in cases with deficient aortic rims.29 One of the most interesting findings of our study was that in 80% of the study patients, the implanted LA disk was in contact with the aorta throughout the cardiac cycle. Prior studies have also reported indentation of the aorta by the LA disk but did not quantify the length of contact between the LA disk and the aorta. In this study, the ASD maximum dimension, LA disk diameter, and the waist size of the implanted device correlated significantly with the length of contact between the LA disk and the aorta. Aortic rim length in our study did not correlate with the LA disk and the aorta contact length, in contrast to one study that reported that aortic rim length was the sole statistically significant predictor of contact between the LA disk and the aorta.18 These findings are of considerable significance given that in most of the reported ASO device tissue erosions, erosion occurred at the atrial dome near the aortic root. Most erosion cases had a deficient aortic rim and/or oversized device.19,20 Almost half of the current 352
study patients had deficient aortic rims (7 of 15) and the devices were considerably oversized. Aortic erosions from ASD closure device have been reported to occur commonly within 72 hours but also as late as 6 years following device implantation and have been associated with serious sequelae such as cardiac tamponade.20,30,31 The incidence of aortic erosion has been low but variable with DiBardino et al.30 reporting an incidence of 0.28% and an FDA pivotal study reporting no erosions.31 These results likely will be underestimates when systematic long-term follow-up studies in this country and abroad are reported. There has been increasing concern recently regarding this complication with the FDA convening an advisory panel to address this issue. The panel mandated tracking of these devices and closer follow-up of these patients.30 Also as mentioned before, the motion of the LA disk was not exactly synchronous with the aortic motion and this could result in friction and shear strain. Thus, 3DTEE could aid in identifying these higher risk patients that may need more frequent postprocedure follow-up. Limitations: The main limitation of the study was the inability of the QLAB software MPR mode thin image slices in assessing the curvilinear (nonplanar) ASD adjacent rim size due to echo signal dropout. The thicker image sections of the Philips 5500 non-MPR mode negated this limitation. Conclusions: In the majority of the study patients, the LA disk was in contact with the aorta throughout the cardiac cycle, the occluder devices were oversized and almost half of the aortic rims were deficient. The aortic contact length significantly correlated with the LA disk size and the LA and RA disk sizes measured by 3DTEE correlated well with the manufacturer obtained sizes, substantiating the ability of 3DTEE in obtaining precise measurements. Routine use of 3DTEE may aid in identifying patients at greater risk for aortic erosion by the ASO device. References 1. King TD, Mills NL: Nonoperative closure of atrial septal defects. Surgery 1974;75:383–388. 2. Chessa M, Carminati M, Butera G, et al: Early and late complications associated with transcatheter occlusion of secundum atrial septal defect. J Am Coll Cardiol 2002;39:1061–1065. 3. Yared K, Baggish AL, Solis J, et al: Echocardiographic assessment of percutaneous patent foramen ovale and atrial septal defect closure complications. Circ Cardiovasc Imaging 2009;2:141–149.
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4. Masura J, Gavora P, Formanek A, et al: 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. 5. Boccalandro F, Baptista E, Muench A, et al: Comparison of intracardiac echocardiography versus transesophageal echocardiography guidance for percutaneous transcatheter closure of atrial septal defect. Am J Cardiol 2004;93:437–440. 6. Butera G, Chessa M, Bossone E, et al: Transcatheter closure of atrial septal defect under combined transesophageal and intracardiac echocardiography. Echocardiography 2003;20:389–390. 7. Hijazi Z, Wang Z, Cao Q, et al: 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. 8. Silvestry FE, Kerber RE, Brook MM, et al: Echocardiography – Guided interventions. J Am Soc Echocardiogr 2009;22:213–231. 9. Vaidyanathan B, Simpson JM, Kumar RK: Transesophageal echocardiography for device closure of atrial septal defects. JACC Cardiovasc Imaging 2009;2:1238–1242. 10. Harper RW, Mottram PM, McGaw DJ: Closure of secundum atrial septal effects with the Amplatzer septal occluder device: Techniques and problems. Catheter Cardiovasc Interv 2002;57:508–524. 11. Acar P, Saliba Z, Bonhoeffer P, et al: Influence of atrial sepal defect anatomy in patient selection and assessment of closure with the Cardioseal device. Eur Heart J 1999;21:573–581. 12. Du ZD, Cao QL, Rhodes J, et al: Choice of device size and results of transcatheter closure of atrial septal defect using the amplatzer septal occluder. J Interv Cardiol 2002;15:287–292. 13. Lodato JA, Cao QL, Weinert L, et al: Feasibility of real time three-dimensional transesophageal for guidance of percutaneous atrial septal defect closure. Eur J Echocardiogr 2009;10:543–548. 14. Sinha A, Nanda NC, Misra V, et al: Live three dimensional transthoracic echocardiographic assessment of transcatheter closure of atrial septal defect and patent foramen ovale. Echocardiography 2004;8:749–753. 15. Chen FL, Hsuing MC, Hsieh KS, et al: Real time threedimensional transthoracic echocardiography for guiding amplatzer septal occluder device deployment in patients with atrial septal defect. Echocardiography 2006;23:763– 770. 16. Fuertes DG, Rubio DM, Ortiz MR, et al: Monitoring complex secundum atrial septal defects percutaneous closure with real time three-dimensional echocardiography. Echocardiography 2012;29:729–734. 17. Roberson DA, Cui W, Patel D, et al: Three-dimensional transesophageal echocardiography of atrial septal defect: A qualitative and quantitative anatomic study. J Am Soc Echocardiogr 2011;24:600–610. 18. Pepi M, Tamborini G, Bartorelli AL, et al: Usefulness of three-dimensional echocardiographic reconstruction of the amplatzer septal occluder in patients undergoing atrial septal closure. Am J Cardiol 2004;94:1343–1347. 19. Amin Z, Hijazi ZM, Bass JL, et al: Erosion of amplatzer septal occluder device after closure of secundum atrial
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Supporting Information Additional Supporting Information may be found in the online version of this article: Movie clips for figures 1, 2, and 7.
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