Efficacy of 3D transoesophageal echocardiography for transcatheter device closure of atrial septal defect without balloon sizing

Efficacy of 3D transoesophageal echocardiography for transcatheter device closure of atrial... Abstract Aims Using balloon sizing to determine device size may cause complications and increase procedure time in performing transcatheter closure of atrial septal defect (ASD). We aimed to validate the clinical utility of a formula using measurements from 3D transoesophageal echocardiography (TOE) images in performing the procedure without balloon sizing. Methods and results We enrolled 248 consecutive patients with ASD in a prospective registry. In the first tier (n = 53), we determined the device size before the procedure using our formula and performed balloon sizing during the procedure to verify our decision. In the second tier (n = 195), the procedure was performed without balloon sizing. In the first tier, the estimated device size correlated well with the device size finally implanted (R = 0.961, P < 0.001; bias, 0.38 ± 1.5 mm, P < 0.001) and with the stretched balloon diameter (R = 0.929, P < 0.001; bias, 0.13 ± 2.0 mm, P < 0.001). In the second tier, the device size derived from the formula was used in all patients, with the exception of one patient who showed a deficient rim on the aorta and superior sides and ASD that was not on a single plane. Two patients with unfavourable morphologies for device implantation experienced embolization of the device. Of the 193 patients with procedural success (99.0%), 2 suffered from haemopericardium caused by atrial wall erosion by the device. There were no procedure-related deaths. Conclusion The transcatheter closure of ASD using the 3D TOE-derived formula without balloon sizing is clinically feasible and safe. However, caution should be taken to exclude unfavourable features of ASD (ClinicalTrials.gov number NCT 02097758). atrial septal defect, 3D echocardiography, transcatheter intervention Introduction Atrial septal defect (ASD) is a common congenital heart disease that is often diagnosed in adulthood. Currently, surgical or percutaneous transcatheter closure is recommended for patients with ASD with a significant shunt without irreversible severe pulmonary hypertension. Devices were introduced for the transcatheter closure of ASD as alternatives to surgical closure.1 Surgical closure has been largely supplanted by percutaneous transcatheter closure, which has increased in use over time as the intervention has shown excellent long-term results.2–4 Selection of the correct device size is important for the success of device closure of ASD, as under- or oversizing may cause complications such as device embolization and laceration of adjacent structures.5 Generally, a balloon sizing procedure is used to determine the optimal ASD device size for percutaneous closure.6 However, this may stretch the rim of the defect and result in an oversized device7–9 and may also cause complications such as balloon rupture, cerebral microembolism, tear of the interatrial septum, and cardiac perforation by the balloon catheter.5,10–13 Furthermore, balloon sizing increases the duration of the procedure, including fluoroscopy-exposure time. Balloon sizing may not be accurate because the waist of the balloon may not have a good profile with cine projection, especially in patients with a large ASD.7,14 Several studies have demonstrated the feasibility of transcatheter closure of ASD without the balloon sizing procedure.8,9,15–17 However, their studies used 2D transoesophageal echocardiography (TOE) or intracardiac echocardiography, which cannot adequately evaluate the entire shape and maximal/minimal diameters of ASD. In most studies, determining the size of the device was arbitrary—it was based on the maximal diameter of ASD. To determine the optimal device size, both the maximal diameter and the shape of ASD should be evaluated. We had suggested a formula using the maximal diameter and circular index of ASD assessed by 3D TOE to determine the device size.18 In this prospective study, we aimed to validate the clinical utility of this formula in performing the procedure without balloon sizing. Methods Study design The prospective registry (ASD_3D_device size, ClinicalTrials.gov number NCT 02097758) is a prospective, single-centre registry to assess the efficacy of 3D TOE for percutaneous device closure in ASD at the Asan Medical Center, a high-volume tertiary center in Korea. Between April 2013 and September 2016, 248 consecutive patients with secundum ASD who were candidates for the transcatheter closure were enrolled prospectively. The study protocol was approved by our institution’s Institutional Review Board. All patients provided informed written consent. This study was implemented in two tiers. In the first tier, the device size was selected using our formula and 3D TOE images obtained before the device closure procedure. During the procedure, we performed balloon sizing to verify our decision about the device size. The final device size was determined after considering the calculated device size and stretched balloon diameter. In the second tier, the procedure was performed using the pre-determined device size without a balloon sizing procedure, to assess the clinical safety and feasibility of our formula. The transcatheter closure procedures were performed using the Amplatzer septal occluder (AGA Medical, Golden Valley, MN, USA). In all procedures, implantation was carried out under general anaesthesia under fluoroscopic and TOE guidance. In the first tier, the Amplatzer sizing balloon II (AGA Medical) was used to measure the stretched balloon diameter of ASD as previously described.18 The procedure times were measured for comparison between the first and second tiers (i.e. with and without balloon sizing procedures). The procedure time was defined as the duration from femoral vein puncture to final catheter removal. Immediately after the procedure, TOE, including colour Doppler images, was performed to determine whether any device malposition, embolization, or significant remnant shunt was present. Patients were prescribed 100 mg/day or more of aspirin for at least 6 months after the procedure.3 On the day following the procedure, all patients underwent transthoracic echocardiography to ensure the position of the device and check for any complications. Selection of device size TOE was performed with an iE33 ultrasound machine and a 3D matrix array 2-7 MHz TOE probe (Philips Medical Systems, Andover, MA, USA) to acquire 2D and 3D full-volume TOE images. Based on the TOE images, the attending physicians determined whether a patient was suitable for transcatheter closure of ASD, and eligible candidates were enrolled in this study. The ASD diameters on 2D TOE images were measured on more than four views at various angles (0–180°), including short-axis images at 30–60° and long-axis images at 90–100°. ASD diameters were measured when the defects were maximally stretched during the end-systolic phase. The 3D full-volume images were acquired using four consecutive beats during patients’ breath-hold to achieve a high temporal resolution. When there were frequent premature beats or patient could not hold breath, a full-volume image was obtained using one beat. Care was taken to optimize the gain and the compression to ensure image quality. Image size and location was adjusted in order to include the entire ASD in the 3D image during the whole cardiac cycle. All 3D images were analysed offline using dedicated software (TomTec GmbH, Munich, Germany). The maximal and minimal planes were determined on multiplanar reconstruction images using guidance on the en face view of ASD. Next, the maximal and minimal diameters of ASD were measured using the two longitudinal planes (Figure 1, see Supplementary data online, Video S1). In our previous study, in 107 consecutive patients who underwent successful transcatheter closure of ASD, the stretched balloon diameters and ASD diameters on 2D and 3D TOE were measured to determine the device size.18 Consequently, a formula for the relationship between the finally selected device size and 3D TOE parameters was constructed. According to the previous study, the optimal ASD device size was calculated as 0.964 × 3Dmax − 2.622 × circular index + 7.084, where 3Dmax indicated maximum diameter and the circular index was defined as the ratio of the maximal to minimal diameters on the 3D TOE image. Figure 1 View largeDownload slide A representative example of measuring the maximal and minimal diameter using multiplanar reconstruction of a 3D TOE image. The blue dashed line represents the plane of maximal diameter and the red dashed line represents minimal diameter. Figure 1 View largeDownload slide A representative example of measuring the maximal and minimal diameter using multiplanar reconstruction of a 3D TOE image. The blue dashed line represents the plane of maximal diameter and the red dashed line represents minimal diameter. Statistical analysis Statistical analysis was performed using IBM SPSS Version 22.0 (IBM Corporation, Armonk, NY, USA). Continuous variables are reported as mean ± standard deviation. Comparisons between measurements were performed using paired t-tests and linear regression analysis. The Bland–Altman analysis was used to evaluate agreement between parameters. A P-value <0.05 was considered statistically significant. Results The baseline characteristics and size measurements are presented in Table 1. In the first tier, a 22-mm balloon was used in 44 patients and a 34-mm balloon in nine patients to measure stretched balloon diameters. All procedures in the first tier were successful, and there were no procedure-related complications. Table 1 Baseline characteristics and measurements of the study population First tier (n = 53)   Age (years)  47 ± 15 (41–55)   Sex (male:female)  14:39   Maximal diameter on 2D TTE (mm)  15.9 ± 5.5 (12.0–19.8)   Maximal diameter on 2D TOE (mm)  17.8 ± 5.8 (13.5–21.5)   Maximal diameter on 3D TOE (mm)  17.2 ± 5.7 (13.0–20.5)   Minimal diameter on 3D TOE (mm)  12.6 ± 4.5 (9.5–15.0)   Averaged diameter on 3D TOE (mm)  14.9 ± 4.9 (11.5–18.3)   Area on 3D TOE (cm2)  1.9 ± 1.2 (1.0–2.6)   Estimated device size by formula (mm)  20.2 ± 5.5 (16.0–24.0)   Stretched balloon diameter (mm)  18.9 ± 5.5 (15.0–23.0)   Device size implanted (mm)  19.7 ± 6.0 (15.5–24.0)   Device waist area (cm2)  3.3 ± 2.0 (2.0–4.5)  Second Tier (n = 195)   Age (years)  46 ± 16 (35–57)   Sex (male:female)  60:135   Maximal diameter on 2D TTE (mm)  15.5 ± 5.4 (11.0–19.0)   Maximal diameter on 2D TOE (mm)  16.9 ± 5.6 (12.0–21.0)   Maximal diameter on 3D TOE (mm)  16.2 ± 5.6 (12.0–20.0)   Minimal diameter on 3D TOE (mm)  12.0 ± 4.8 (9.0–15.0)   Averaged diameter on 3D TOE (mm)  14.1 ± 5.0 (10.0–18.0)   Area on 3D TOE (cm2)  1.7 ± 1.2 (0.8-2.4)   Estimated device size by formula (mm)  19.2 ± 5.7 (15.0–24.0)   Device size implanted (mm)  19.3 ± 5.8 (15.0–24.0)   Device waist area (cm2)  3.2 ± 1.8 (1.8-4.5)  First tier (n = 53)   Age (years)  47 ± 15 (41–55)   Sex (male:female)  14:39   Maximal diameter on 2D TTE (mm)  15.9 ± 5.5 (12.0–19.8)   Maximal diameter on 2D TOE (mm)  17.8 ± 5.8 (13.5–21.5)   Maximal diameter on 3D TOE (mm)  17.2 ± 5.7 (13.0–20.5)   Minimal diameter on 3D TOE (mm)  12.6 ± 4.5 (9.5–15.0)   Averaged diameter on 3D TOE (mm)  14.9 ± 4.9 (11.5–18.3)   Area on 3D TOE (cm2)  1.9 ± 1.2 (1.0–2.6)   Estimated device size by formula (mm)  20.2 ± 5.5 (16.0–24.0)   Stretched balloon diameter (mm)  18.9 ± 5.5 (15.0–23.0)   Device size implanted (mm)  19.7 ± 6.0 (15.5–24.0)   Device waist area (cm2)  3.3 ± 2.0 (2.0–4.5)  Second Tier (n = 195)   Age (years)  46 ± 16 (35–57)   Sex (male:female)  60:135   Maximal diameter on 2D TTE (mm)  15.5 ± 5.4 (11.0–19.0)   Maximal diameter on 2D TOE (mm)  16.9 ± 5.6 (12.0–21.0)   Maximal diameter on 3D TOE (mm)  16.2 ± 5.6 (12.0–20.0)   Minimal diameter on 3D TOE (mm)  12.0 ± 4.8 (9.0–15.0)   Averaged diameter on 3D TOE (mm)  14.1 ± 5.0 (10.0–18.0)   Area on 3D TOE (cm2)  1.7 ± 1.2 (0.8-2.4)   Estimated device size by formula (mm)  19.2 ± 5.7 (15.0–24.0)   Device size implanted (mm)  19.3 ± 5.8 (15.0–24.0)   Device waist area (cm2)  3.2 ± 1.8 (1.8-4.5)  TOE, transoesophageal echocardiography; TTE, transthoracic echocardiography. Table 1 Baseline characteristics and measurements of the study population First tier (n = 53)   Age (years)  47 ± 15 (41–55)   Sex (male:female)  14:39   Maximal diameter on 2D TTE (mm)  15.9 ± 5.5 (12.0–19.8)   Maximal diameter on 2D TOE (mm)  17.8 ± 5.8 (13.5–21.5)   Maximal diameter on 3D TOE (mm)  17.2 ± 5.7 (13.0–20.5)   Minimal diameter on 3D TOE (mm)  12.6 ± 4.5 (9.5–15.0)   Averaged diameter on 3D TOE (mm)  14.9 ± 4.9 (11.5–18.3)   Area on 3D TOE (cm2)  1.9 ± 1.2 (1.0–2.6)   Estimated device size by formula (mm)  20.2 ± 5.5 (16.0–24.0)   Stretched balloon diameter (mm)  18.9 ± 5.5 (15.0–23.0)   Device size implanted (mm)  19.7 ± 6.0 (15.5–24.0)   Device waist area (cm2)  3.3 ± 2.0 (2.0–4.5)  Second Tier (n = 195)   Age (years)  46 ± 16 (35–57)   Sex (male:female)  60:135   Maximal diameter on 2D TTE (mm)  15.5 ± 5.4 (11.0–19.0)   Maximal diameter on 2D TOE (mm)  16.9 ± 5.6 (12.0–21.0)   Maximal diameter on 3D TOE (mm)  16.2 ± 5.6 (12.0–20.0)   Minimal diameter on 3D TOE (mm)  12.0 ± 4.8 (9.0–15.0)   Averaged diameter on 3D TOE (mm)  14.1 ± 5.0 (10.0–18.0)   Area on 3D TOE (cm2)  1.7 ± 1.2 (0.8-2.4)   Estimated device size by formula (mm)  19.2 ± 5.7 (15.0–24.0)   Device size implanted (mm)  19.3 ± 5.8 (15.0–24.0)   Device waist area (cm2)  3.2 ± 1.8 (1.8-4.5)  First tier (n = 53)   Age (years)  47 ± 15 (41–55)   Sex (male:female)  14:39   Maximal diameter on 2D TTE (mm)  15.9 ± 5.5 (12.0–19.8)   Maximal diameter on 2D TOE (mm)  17.8 ± 5.8 (13.5–21.5)   Maximal diameter on 3D TOE (mm)  17.2 ± 5.7 (13.0–20.5)   Minimal diameter on 3D TOE (mm)  12.6 ± 4.5 (9.5–15.0)   Averaged diameter on 3D TOE (mm)  14.9 ± 4.9 (11.5–18.3)   Area on 3D TOE (cm2)  1.9 ± 1.2 (1.0–2.6)   Estimated device size by formula (mm)  20.2 ± 5.5 (16.0–24.0)   Stretched balloon diameter (mm)  18.9 ± 5.5 (15.0–23.0)   Device size implanted (mm)  19.7 ± 6.0 (15.5–24.0)   Device waist area (cm2)  3.3 ± 2.0 (2.0–4.5)  Second Tier (n = 195)   Age (years)  46 ± 16 (35–57)   Sex (male:female)  60:135   Maximal diameter on 2D TTE (mm)  15.5 ± 5.4 (11.0–19.0)   Maximal diameter on 2D TOE (mm)  16.9 ± 5.6 (12.0–21.0)   Maximal diameter on 3D TOE (mm)  16.2 ± 5.6 (12.0–20.0)   Minimal diameter on 3D TOE (mm)  12.0 ± 4.8 (9.0–15.0)   Averaged diameter on 3D TOE (mm)  14.1 ± 5.0 (10.0–18.0)   Area on 3D TOE (cm2)  1.7 ± 1.2 (0.8-2.4)   Estimated device size by formula (mm)  19.2 ± 5.7 (15.0–24.0)   Device size implanted (mm)  19.3 ± 5.8 (15.0–24.0)   Device waist area (cm2)  3.2 ± 1.8 (1.8-4.5)  TOE, transoesophageal echocardiography; TTE, transthoracic echocardiography. Based on these first-tier results, we decided to select optimal device size by rounding off the calculated value using our formula. As the sizes of the Amplatzer device increase by 2 mm in devices above 20 mm, we selected right upper numerical values if the results of formula gave odd numbers above 20 mm, e.g. if the result of formula was 21 mm than we used 22 mm size of device. The optimal device size determined by the method described above was 20.2 ± 5.5 mm. The device size that was finally implanted after the balloon sizing procedure was 19.7 ± 6.0 mm. There was an excellent correlation between the optimal device sizes and the sizes of the devices finally implanted (R = 0.961, P < 0.001, Figure 2A). The device sizes estimated using our formula were larger than the device sizes finally implanted by a mean difference of 0.38 ± 1.5 mm (P < 0.001). This difference must be caused by stretched balloon sizing results, and there were some who were upsized and some downsized as shown in Figure 2A. However, the mean difference was not large enough to result in changing the device size that validated clinical feasibility of our formula. Figure 2 View largeDownload slide Correlations and Bland–Altman plots between estimated device size and device size finally implanted (A) and between estimated device size and stretched balloon diameter (SBD) in the first tier (B). On the correlation graphs, solid lines represent lines of identity, and dashed lines represent linear regression. On the Bland–Altman plots, solid lines represent average differences, and dashed lines represent average difference ± 1.96 standard deviation of the difference. Figure 2 View largeDownload slide Correlations and Bland–Altman plots between estimated device size and device size finally implanted (A) and between estimated device size and stretched balloon diameter (SBD) in the first tier (B). On the correlation graphs, solid lines represent lines of identity, and dashed lines represent linear regression. On the Bland–Altman plots, solid lines represent average differences, and dashed lines represent average difference ± 1.96 standard deviation of the difference. There was a significant correlation between the estimated device sizes and stretched balloon diameters (R = 0.929, P < 0.001, Figure 2B). However, the stretched balloon diameter could not be appropriately measured in some patients with large ASD, because the balloon position was not stable and the waist of balloon could not be clearly visualized. The stretched balloon diameters might have been underestimated due to this technical difficulty, and device size determination was more reliant on using 3D TOE images in those patients. Furthermore, the estimated sizes derived by our formula were odd number above 20 mm, and right upper numerical values were selected in 12 cases. Consequently, the stretched balloon diameter was smaller than the estimated device size by an average of 1.30 mm. In the second tier, 195 patients underwent transcatheter device closure of ASD without the balloon sizing procedure. Of these, 193 (99.0%) patients showed procedural success. The device size derived from the formula was used in all patients, with the exception of one patient (Figure 3). That patient showed a deficient rim on the aorta and superior sides, and the ASD was not on a single plane. The septum primum was attached on the left atrial side more than the septum secundum. The device of the estimated size could not be implanted securely; consequently, a larger sized device was successfully implanted. Figure 3 View largeDownload slide TOE images of the patient who underwent the procedure with a larger sized device than estimated by the formula. Red arrowheads represent the septum primum attached on the left atrial side more than the septum secundum. Figure 3 View largeDownload slide TOE images of the patient who underwent the procedure with a larger sized device than estimated by the formula. Red arrowheads represent the septum primum attached on the left atrial side more than the septum secundum. There were two cases of procedural failure with embolization of the device. In one patient, the device was successfully retrieved using a gooseneck snare, and surgical repair of ASD was performed. The other patient underwent emergent surgery for device retrieval and ASD closure. After reviewing the images for these two patients, we determined that they might not have been good candidates for percutaneous device closure. One patient showed tunnel-shaped ASD resembling the shape of patent foramen ovale, which was not on a single plane. The septum primum was attached to the left atrial side more than the septum secundum (see Supplementary data online, Figure S1). In the other patient, the interatrial septum showed aneurysm and elliptical ASD located along the margin of the aneurysm (see Supplementary data online, Figure S2). Of the second-tier patients with successful procedures, one patient presented with chest pain and dyspnoea the day following the intervention. Transthoracic echocardiography showed haemopericardium. This patient underwent emergent open-heart surgery, and erosion of the left atrial wall and adjacent aorta by a sharp left atrial device disc was revealed. The erosion was repaired, and ASD was closed using pericardium. The patient was discharged without any further complications 7 days after surgery. There were no procedure-related deaths. During the median follow-up period of 9 months (range 5–19 months) for 192 patients without in-hospital complications, another patient in the second tier underwent open-heart surgery at 19 days after ASD closure due to haemopericardium caused by right atrial posterior wall laceration by the device disc. In 10 patients (4 in the first tier and 6 in the second tier), a special assisted balloon technique using a supporting balloon inflated in the left atrium was implemented to secure the position of the device upon deployment because the standard deployment procedure failed.19 In these patients, the maximum diameter of ASD on 2D images was 24.0 ± 6.2 mm and on 3D TOE was 23.2 ± 6.0 mm. The size of the device finally implanted was 27.8 ± 7.3 mm. These patients showed a prolonged procedure time (44.4 ± 21.3 min) due to implementing a supporting balloon technique. When these cases were excluded, the mean procedure time was shorter in the second tier compared with the first tier (19 ± 6 vs 33 ± 10 min, P < 0.001). Discussion Determining the device size for transcatheter closure of ASD using balloon sizing has been regarded as the gold standard. However, several studies have been conducted to obviate the need for balloon sizing during the intervention, as it is a time-consuming and cumbersome procedure and may also cause complications as described earlier. Wang et al.8 demonstrated the safety and feasibility of transcatheter closure of ASD without balloon sizing by comparing outcomes between patients who underwent the procedure with and without balloon sizing. However, selection of device size was arbitrary and depended on the maximal size measured from 2D TOE. If an appropriate imaging plane of the maximal diameter was missed, the maximal diameter might be underestimated. Zanchetta et al.17 demonstrated intracardiac echocardiography-guided transcatheter closure of ASD using two standardized orthogonal diameters and a complex mathematical geometric equation. However, the major limitation of this study was these orthogonal diameters might not be equal to the maximal and minimal diameters of ASD; therefore, the derivation of quantitative data from geometric assumptions could be a major limitation of that study. 3D TOE provides an en face view of the entire ASD and helps to evaluate the shape of ASD and measure the maximal and minimal diameters.20 In our previously study, we demonstrated that the relationship between balloon sizing and maximal diameters measured using TOE was influenced by ASD shape and size,18 which has been corroborated by other studies.21,22 The mean difference between balloon sizing and the maximal diameter was higher in round ASDs than in oval ASDs. Therefore, ASD shape should be considered as well as size when determining device size without balloon sizing. From our previous study, we developed a formula for the relationship between the finally selected device size and 3D TOE parameters, and this equation was derived from our study including all of the diameters measured on 2D and 3D TOE, stretched balloon diameters, and finally selected device sizes that resulted in procedural success. Therefore, our formula differs from the formula suggested in another study, which demonstrated the relationship between balloon sizing and the maximal diameter on 3D TOE.22 In that study, ASD shape was not quantitatively evaluated and clinical utility of their formula for determining device size could not be validated. Our present study demonstrated that transcatheter closure of ASD with the device size determined by our formula using the 3D TOE images obtained before intervention and without balloon sizing was clinically useful and safe in most patients. In the first tier, we validated the decision about device size derived from our formula with a stretched balloon diameter and confirmed that this formula could be used in the second tier. We also found that the device size estimated using the formula was more reliable than the stretched balloon diameter in some patients with large ASD, as the balloon position was not stable and the waist of balloon could not be clearly visualized. The procedural success rate was 100% in the first tier, in which the device size was mainly determined by our formula using 3D TOE images. In the second tier, where balloon sizing was not used, the procedural success rate was 99.0%. However, there were two cases of device embolization after release of the device from the catheter. We subsequently found out that these cases were not good candidates for transcatheter closure, as presented in the Results, and procedural failure was caused by patient selection rather than a fault in our formula. These results suggest that patient selection is important, and our formula is clinically feasible and safe if used for patients with favourable ASD morphology suitable for transcatheter closure. As demonstrated in this study, the transcatheter closure of ASD using pre-determined device size based on 3D TOE images reduced the procedure time and helped to prevent potential complications caused by the balloon sizing procedure. Although our study population included some patients who did not have a favourable morphology of ASD, the procedural success rate in the second tier (99.0%) was superior or comparable to previous studies that demonstrated clinical feasibility of transcatheter ASD closure without balloon sizing procedures.8,9 Two patients in our study population experienced erosion of the left atrial wall and aorta or right atrial posterior wall by left or right atrial discs. Similar to our cases, there have been other case reports and reviews about atrial wall erosion after implantation of Amplatzer septal occluders.14,23,24 It is not certain whether this complication is due to deficient retroaortic or posterior rims, an under- or oversized device, geometry of the septum and aorta, or the matter of the device itself.25 The relationship between cardiac erosion and oversizing is controversial. According to survey to members of Congenital Cardiovascular Interventional Study Consortium, devices with lower risk of erosion are those that straddle the aorta, are somewhat oversized, while devices with higher risk are those with protruding left atrial disk into the aortic root, are somewhat undersized.26 We could not find any definite cause for this complication, as device size and position appeared appropriate after deployment, and the patients did not complain of any serious symptoms on the day of the intervention. Regular follow-up is necessary to determine whether this rare complication develops after the procedure, even for patients who underwent successful closure with the Amplatzer device. Our study has several limitations. First, unfavourable candidates for device closure could not be completely excluded from the study, which resulted in device embolization. However, these results allowed us to identify unfavourable morphologies of ASD and exclude those patients from further registry enrolment. We believe that procedural success rate will be improved with a more strict patient selection. Secondly, only Amplatzer septal occluders were used, and our results may not be simply extrapolated to other devices for transcatheter closure of ASD. Further studies will be needed to verify the clinical value of applying our method to other devices. Finally, in the second-tier cohort, there were higher rates of complications compared with a safety review of large population.26 A more strict patient selection considering unfavourable shape of ASD and rim deficiency would be needed for using our formula. Conclusions Transcatheter closure of ASD using the 3D TOE-derived formula without balloon sizing is clinically feasible and safe. However, caution should be taken to exclude patients with unfavourable features of ASD. Supplementary data Supplementary data are available at European Heart Journal - Cardiovascular Imaging online. Conflict of interest: None declared. References 1 Fischer G, Kramer HH, Stieh J, Harding P, Jung O. Transcatheter closure of secundum atrial septal defects with the new self-centering Amplatzer Septal Occluder. Eur Heart J  1999; 20: 541– 9. Google Scholar CrossRef Search ADS PubMed  2 Karamlou T, Diggs BS, Ungerleider RM, McCrindle BW, Welke KF. The rush to atrial septal defect closure: is the introduction of percutaneous closure driving utilization? Ann Thorac Surg  2008; 86: 1584– 90; discussion 1590–1. Google Scholar CrossRef Search ADS PubMed  3 Majunke N, Bialkowski J, Wilson N, Szkutnik M, Kusa J, Baranowski A et al.   Closure of atrial septal defect with the Amplatzer septal occluder in adults. Am J Cardiol  2009; 103: 550– 4. Google Scholar CrossRef Search ADS PubMed  4 Rigatelli G, Dell’Avvocata F, Cardaioli P, Giordan M, Braggion G, Aggio S et al.   Five-year follow-up of transcatheter intracardiac echocardiography-assisted closure of interatrial shunts. Cardiovasc Revasc Med  2011; 12: 355– 61. Google Scholar CrossRef Search ADS PubMed  5 Chessa M, Carminati M, Butera G, Bini RM, Drago M, Rosti L et al.   Early and late complications associated with transcatheter occlusion of secundum atrial septal defect. J Am Coll Cardiol  2002; 39: 1061– 5. Google Scholar CrossRef Search ADS PubMed  6 Rao PS, Langhough R. Relationship of echocardiographic, shunt flow, and angiographic size to the stretched diameter of the atrial septal defect. Am Heart J  1991; 122: 505– 8. Google Scholar CrossRef Search ADS PubMed  7 Carlson KM, Justino H, O’Brien RE, Dimas VV, Leonard GTJr, Pignatelli RH et al.   Transcatheter atrial septal defect closure: modified balloon sizing technique to avoid overstretching the defect and oversizing the Amplatzer septal occluder. Cathet Cardiovasc Intervent  2005; 66: 390– 6. Google Scholar CrossRef Search ADS   8 Wang JK, Tsai SK, Lin SM, Chiu SN, Lin MT, Wu MH. Transcatheter closure of atrial septal defect without balloon sizing. Cathet Cardiovasc Intervent  2008; 71: 214– 21. Google Scholar CrossRef Search ADS   9 Gupta SK, Sivasankaran S, Bijulal S, Tharakan JM, Harikrishnan S, Ajit K. Trans-catheter closure of atrial septal defect: balloon sizing or no balloon sizing—single centre experience. Ann Pediatr Cardiol  2011; 4: 28– 33. Google Scholar CrossRef Search ADS PubMed  10 Harikrishnan S, Narayanan NK, Sivasubramonian S. Sizing balloon-induced tear of the atrial septum. J Invasive Cardiol  2005; 17: 546– 7. Google Scholar PubMed  11 Alsaileek AA, Omran A, Godman M, Najm HK. Echocardiographic visualization of laceration of atrial septum during balloon sizing of atrial septal defect. Eur J Echocardiogr  2007; 8: 155– 7. Google Scholar CrossRef Search ADS PubMed  12 Kijima Y, Taniguchi M, Akagi T, Nakagawa K, Kusano K, Ito H et al.   Torn atrial septum during transcatheter closure of atrial septal defect visualized by real-time three-dimensional transesophageal echocardiography. J Am Soc Echocardiogr  2010; 23: 1222.e1225– 8. Google Scholar CrossRef Search ADS   13 Wallace S, Dohlen G, Holmstrom H, Lund C, Russell D. Cerebral microemboli detection and differentiation during transcatheter closure of atrial septal defect in a paediatric population. Cardiol Young  2014; 25: 237– 44. Google Scholar CrossRef Search ADS PubMed  14 Amin Z, Hijazi ZM, Bass JL, Cheatham JP, Hellenbrand WE, Kleinman CS. Erosion of Amplatzer septal occluder device after closure of secundum atrial septal defects: review of registry of complications and recommendations to minimize future risk. Cathet Cardiovasc Intervent  2004; 63: 496– 502. Google Scholar CrossRef Search ADS   15 Rigatelli G, Dell'avvocata F, Cardaioli P, Giordan M, Dung HT, Nghia NT et al.   Safety and long-term outcome of modified intracardiac echocardiography-assisted ‘no-balloon’ sizing technique for transcatheter closure of ostium secundum atrial septal defect. J Interv Cardiol  2012; 25: 628– 34. Google Scholar CrossRef Search ADS PubMed  16 Quek SC, Wu WX, Chan KY, Ho TF, Yip WC. Transcatheter closure of atrial septal defects–is balloon sizing still necessary? Ann Acad Med Singapore  2010; 39: 390– 3. Google Scholar PubMed  17 Zanchetta M, Onorato E, Rigatelli G, Pedon L, Zennaro M, Carrozza A et al.   Intracardiac echocardiography-guided transcatheter closure of secundum atrial septal defect: a new efficient device selection method. J Am Coll Cardiol  2003; 42: 1677– 82. Google Scholar CrossRef Search ADS PubMed  18 Seo JS, Song JM, Kim YH, Park DW, Lee SW, Kim WJ et al.   Effect of atrial septal defect shape evaluated using three-dimensional transesophageal echocardiography on size measurements for percutaneous closure. J Am Soc Echocardiogr  2012; 25: 1031– 40. Google Scholar CrossRef Search ADS PubMed  19 Kammache I, Mancini J, Ovaert C, Habib G, Fraisse A. Feasibility of transcatheter closure in unselected patients with secundum atrial septal defect, using Amplatzer devices and a modified sizing balloon technique. Cathet Cardiovasc Intervent  2011; 78: 665– 74. Google Scholar CrossRef Search ADS   20 Roberson DA, Cui W, Patel D, Tsang W, Sugeng L, Weinert L et al.   Three-dimensional transesophageal echocardiography of atrial septal defect: a qualitative and quantitative anatomic study. J Am Soc Echocardiogr  2011; 24: 600– 10. Google Scholar CrossRef Search ADS PubMed  21 Acar P, Saliba Z, Bonhoeffer P, Aggoun Y, Bonnet D, Sidi D et al.   Influence of atrial septal defect anatomy in patient selection and assessment of closure with the Cardioseal device: a three-dimensional transoesophageal echocardiographic reconstruction. Eur Heart J  2000; 21: 573– 81. Google Scholar CrossRef Search ADS PubMed  22 Hascoet S, Hadeed K, Marchal P, Dulac Y, Alacoque X, Heitz F et al.   The relation between atrial septal defect shape, diameter, and area using three-dimensional transoesophageal echocardiography and balloon sizing during percutaneous closure in children. Eur Heart J Cardiovasc Imaging  2015; 16: 747– 55. Google Scholar CrossRef Search ADS PubMed  23 El-Said HG, Moore JW. Erosion by the Amplatzer septal occluder: experienced operator opinions at odds with manufacturer recommendations? Cathet Cardiovasc Intervent  2009; 73: 925– 30. Google Scholar CrossRef Search ADS   24 Divekar A, Gaamangwe T, Shaikh N, Raabe M, Ducas J. Cardiac perforation after device closure of atrial septal defects with the Amplatzer septal occluder. J Am Coll Cardiol  2005; 45: 1213– 8. Google Scholar CrossRef Search ADS PubMed  25 Crawford GB, Brindis RG, Krucoff MW, Mansalis BP, Carroll JD. Percutaneous atrial septal occluder devices and cardiac erosion: a review of the literature. Cathet Cardiovasc Intervent  2012; 80: 157– 67. Google Scholar CrossRef Search ADS   26 Moore J, Hegde S, El-Said H, Beekman R3rd, Benson L, Bergersen L et al.   Transcatheter device closure of atrial septal defects: a safety review. JACC Cardiovasc Interv  2013; 6: 433– 42. Google Scholar CrossRef Search ADS PubMed  Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/about_us/legal/notices) http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png European Heart Journal – Cardiovascular Imaging Oxford University Press

Efficacy of 3D transoesophageal echocardiography for transcatheter device closure of atrial septal defect without balloon sizing

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Abstract

Abstract Aims Using balloon sizing to determine device size may cause complications and increase procedure time in performing transcatheter closure of atrial septal defect (ASD). We aimed to validate the clinical utility of a formula using measurements from 3D transoesophageal echocardiography (TOE) images in performing the procedure without balloon sizing. Methods and results We enrolled 248 consecutive patients with ASD in a prospective registry. In the first tier (n = 53), we determined the device size before the procedure using our formula and performed balloon sizing during the procedure to verify our decision. In the second tier (n = 195), the procedure was performed without balloon sizing. In the first tier, the estimated device size correlated well with the device size finally implanted (R = 0.961, P < 0.001; bias, 0.38 ± 1.5 mm, P < 0.001) and with the stretched balloon diameter (R = 0.929, P < 0.001; bias, 0.13 ± 2.0 mm, P < 0.001). In the second tier, the device size derived from the formula was used in all patients, with the exception of one patient who showed a deficient rim on the aorta and superior sides and ASD that was not on a single plane. Two patients with unfavourable morphologies for device implantation experienced embolization of the device. Of the 193 patients with procedural success (99.0%), 2 suffered from haemopericardium caused by atrial wall erosion by the device. There were no procedure-related deaths. Conclusion The transcatheter closure of ASD using the 3D TOE-derived formula without balloon sizing is clinically feasible and safe. However, caution should be taken to exclude unfavourable features of ASD (ClinicalTrials.gov number NCT 02097758). atrial septal defect, 3D echocardiography, transcatheter intervention Introduction Atrial septal defect (ASD) is a common congenital heart disease that is often diagnosed in adulthood. Currently, surgical or percutaneous transcatheter closure is recommended for patients with ASD with a significant shunt without irreversible severe pulmonary hypertension. Devices were introduced for the transcatheter closure of ASD as alternatives to surgical closure.1 Surgical closure has been largely supplanted by percutaneous transcatheter closure, which has increased in use over time as the intervention has shown excellent long-term results.2–4 Selection of the correct device size is important for the success of device closure of ASD, as under- or oversizing may cause complications such as device embolization and laceration of adjacent structures.5 Generally, a balloon sizing procedure is used to determine the optimal ASD device size for percutaneous closure.6 However, this may stretch the rim of the defect and result in an oversized device7–9 and may also cause complications such as balloon rupture, cerebral microembolism, tear of the interatrial septum, and cardiac perforation by the balloon catheter.5,10–13 Furthermore, balloon sizing increases the duration of the procedure, including fluoroscopy-exposure time. Balloon sizing may not be accurate because the waist of the balloon may not have a good profile with cine projection, especially in patients with a large ASD.7,14 Several studies have demonstrated the feasibility of transcatheter closure of ASD without the balloon sizing procedure.8,9,15–17 However, their studies used 2D transoesophageal echocardiography (TOE) or intracardiac echocardiography, which cannot adequately evaluate the entire shape and maximal/minimal diameters of ASD. In most studies, determining the size of the device was arbitrary—it was based on the maximal diameter of ASD. To determine the optimal device size, both the maximal diameter and the shape of ASD should be evaluated. We had suggested a formula using the maximal diameter and circular index of ASD assessed by 3D TOE to determine the device size.18 In this prospective study, we aimed to validate the clinical utility of this formula in performing the procedure without balloon sizing. Methods Study design The prospective registry (ASD_3D_device size, ClinicalTrials.gov number NCT 02097758) is a prospective, single-centre registry to assess the efficacy of 3D TOE for percutaneous device closure in ASD at the Asan Medical Center, a high-volume tertiary center in Korea. Between April 2013 and September 2016, 248 consecutive patients with secundum ASD who were candidates for the transcatheter closure were enrolled prospectively. The study protocol was approved by our institution’s Institutional Review Board. All patients provided informed written consent. This study was implemented in two tiers. In the first tier, the device size was selected using our formula and 3D TOE images obtained before the device closure procedure. During the procedure, we performed balloon sizing to verify our decision about the device size. The final device size was determined after considering the calculated device size and stretched balloon diameter. In the second tier, the procedure was performed using the pre-determined device size without a balloon sizing procedure, to assess the clinical safety and feasibility of our formula. The transcatheter closure procedures were performed using the Amplatzer septal occluder (AGA Medical, Golden Valley, MN, USA). In all procedures, implantation was carried out under general anaesthesia under fluoroscopic and TOE guidance. In the first tier, the Amplatzer sizing balloon II (AGA Medical) was used to measure the stretched balloon diameter of ASD as previously described.18 The procedure times were measured for comparison between the first and second tiers (i.e. with and without balloon sizing procedures). The procedure time was defined as the duration from femoral vein puncture to final catheter removal. Immediately after the procedure, TOE, including colour Doppler images, was performed to determine whether any device malposition, embolization, or significant remnant shunt was present. Patients were prescribed 100 mg/day or more of aspirin for at least 6 months after the procedure.3 On the day following the procedure, all patients underwent transthoracic echocardiography to ensure the position of the device and check for any complications. Selection of device size TOE was performed with an iE33 ultrasound machine and a 3D matrix array 2-7 MHz TOE probe (Philips Medical Systems, Andover, MA, USA) to acquire 2D and 3D full-volume TOE images. Based on the TOE images, the attending physicians determined whether a patient was suitable for transcatheter closure of ASD, and eligible candidates were enrolled in this study. The ASD diameters on 2D TOE images were measured on more than four views at various angles (0–180°), including short-axis images at 30–60° and long-axis images at 90–100°. ASD diameters were measured when the defects were maximally stretched during the end-systolic phase. The 3D full-volume images were acquired using four consecutive beats during patients’ breath-hold to achieve a high temporal resolution. When there were frequent premature beats or patient could not hold breath, a full-volume image was obtained using one beat. Care was taken to optimize the gain and the compression to ensure image quality. Image size and location was adjusted in order to include the entire ASD in the 3D image during the whole cardiac cycle. All 3D images were analysed offline using dedicated software (TomTec GmbH, Munich, Germany). The maximal and minimal planes were determined on multiplanar reconstruction images using guidance on the en face view of ASD. Next, the maximal and minimal diameters of ASD were measured using the two longitudinal planes (Figure 1, see Supplementary data online, Video S1). In our previous study, in 107 consecutive patients who underwent successful transcatheter closure of ASD, the stretched balloon diameters and ASD diameters on 2D and 3D TOE were measured to determine the device size.18 Consequently, a formula for the relationship between the finally selected device size and 3D TOE parameters was constructed. According to the previous study, the optimal ASD device size was calculated as 0.964 × 3Dmax − 2.622 × circular index + 7.084, where 3Dmax indicated maximum diameter and the circular index was defined as the ratio of the maximal to minimal diameters on the 3D TOE image. Figure 1 View largeDownload slide A representative example of measuring the maximal and minimal diameter using multiplanar reconstruction of a 3D TOE image. The blue dashed line represents the plane of maximal diameter and the red dashed line represents minimal diameter. Figure 1 View largeDownload slide A representative example of measuring the maximal and minimal diameter using multiplanar reconstruction of a 3D TOE image. The blue dashed line represents the plane of maximal diameter and the red dashed line represents minimal diameter. Statistical analysis Statistical analysis was performed using IBM SPSS Version 22.0 (IBM Corporation, Armonk, NY, USA). Continuous variables are reported as mean ± standard deviation. Comparisons between measurements were performed using paired t-tests and linear regression analysis. The Bland–Altman analysis was used to evaluate agreement between parameters. A P-value <0.05 was considered statistically significant. Results The baseline characteristics and size measurements are presented in Table 1. In the first tier, a 22-mm balloon was used in 44 patients and a 34-mm balloon in nine patients to measure stretched balloon diameters. All procedures in the first tier were successful, and there were no procedure-related complications. Table 1 Baseline characteristics and measurements of the study population First tier (n = 53)   Age (years)  47 ± 15 (41–55)   Sex (male:female)  14:39   Maximal diameter on 2D TTE (mm)  15.9 ± 5.5 (12.0–19.8)   Maximal diameter on 2D TOE (mm)  17.8 ± 5.8 (13.5–21.5)   Maximal diameter on 3D TOE (mm)  17.2 ± 5.7 (13.0–20.5)   Minimal diameter on 3D TOE (mm)  12.6 ± 4.5 (9.5–15.0)   Averaged diameter on 3D TOE (mm)  14.9 ± 4.9 (11.5–18.3)   Area on 3D TOE (cm2)  1.9 ± 1.2 (1.0–2.6)   Estimated device size by formula (mm)  20.2 ± 5.5 (16.0–24.0)   Stretched balloon diameter (mm)  18.9 ± 5.5 (15.0–23.0)   Device size implanted (mm)  19.7 ± 6.0 (15.5–24.0)   Device waist area (cm2)  3.3 ± 2.0 (2.0–4.5)  Second Tier (n = 195)   Age (years)  46 ± 16 (35–57)   Sex (male:female)  60:135   Maximal diameter on 2D TTE (mm)  15.5 ± 5.4 (11.0–19.0)   Maximal diameter on 2D TOE (mm)  16.9 ± 5.6 (12.0–21.0)   Maximal diameter on 3D TOE (mm)  16.2 ± 5.6 (12.0–20.0)   Minimal diameter on 3D TOE (mm)  12.0 ± 4.8 (9.0–15.0)   Averaged diameter on 3D TOE (mm)  14.1 ± 5.0 (10.0–18.0)   Area on 3D TOE (cm2)  1.7 ± 1.2 (0.8-2.4)   Estimated device size by formula (mm)  19.2 ± 5.7 (15.0–24.0)   Device size implanted (mm)  19.3 ± 5.8 (15.0–24.0)   Device waist area (cm2)  3.2 ± 1.8 (1.8-4.5)  First tier (n = 53)   Age (years)  47 ± 15 (41–55)   Sex (male:female)  14:39   Maximal diameter on 2D TTE (mm)  15.9 ± 5.5 (12.0–19.8)   Maximal diameter on 2D TOE (mm)  17.8 ± 5.8 (13.5–21.5)   Maximal diameter on 3D TOE (mm)  17.2 ± 5.7 (13.0–20.5)   Minimal diameter on 3D TOE (mm)  12.6 ± 4.5 (9.5–15.0)   Averaged diameter on 3D TOE (mm)  14.9 ± 4.9 (11.5–18.3)   Area on 3D TOE (cm2)  1.9 ± 1.2 (1.0–2.6)   Estimated device size by formula (mm)  20.2 ± 5.5 (16.0–24.0)   Stretched balloon diameter (mm)  18.9 ± 5.5 (15.0–23.0)   Device size implanted (mm)  19.7 ± 6.0 (15.5–24.0)   Device waist area (cm2)  3.3 ± 2.0 (2.0–4.5)  Second Tier (n = 195)   Age (years)  46 ± 16 (35–57)   Sex (male:female)  60:135   Maximal diameter on 2D TTE (mm)  15.5 ± 5.4 (11.0–19.0)   Maximal diameter on 2D TOE (mm)  16.9 ± 5.6 (12.0–21.0)   Maximal diameter on 3D TOE (mm)  16.2 ± 5.6 (12.0–20.0)   Minimal diameter on 3D TOE (mm)  12.0 ± 4.8 (9.0–15.0)   Averaged diameter on 3D TOE (mm)  14.1 ± 5.0 (10.0–18.0)   Area on 3D TOE (cm2)  1.7 ± 1.2 (0.8-2.4)   Estimated device size by formula (mm)  19.2 ± 5.7 (15.0–24.0)   Device size implanted (mm)  19.3 ± 5.8 (15.0–24.0)   Device waist area (cm2)  3.2 ± 1.8 (1.8-4.5)  TOE, transoesophageal echocardiography; TTE, transthoracic echocardiography. Table 1 Baseline characteristics and measurements of the study population First tier (n = 53)   Age (years)  47 ± 15 (41–55)   Sex (male:female)  14:39   Maximal diameter on 2D TTE (mm)  15.9 ± 5.5 (12.0–19.8)   Maximal diameter on 2D TOE (mm)  17.8 ± 5.8 (13.5–21.5)   Maximal diameter on 3D TOE (mm)  17.2 ± 5.7 (13.0–20.5)   Minimal diameter on 3D TOE (mm)  12.6 ± 4.5 (9.5–15.0)   Averaged diameter on 3D TOE (mm)  14.9 ± 4.9 (11.5–18.3)   Area on 3D TOE (cm2)  1.9 ± 1.2 (1.0–2.6)   Estimated device size by formula (mm)  20.2 ± 5.5 (16.0–24.0)   Stretched balloon diameter (mm)  18.9 ± 5.5 (15.0–23.0)   Device size implanted (mm)  19.7 ± 6.0 (15.5–24.0)   Device waist area (cm2)  3.3 ± 2.0 (2.0–4.5)  Second Tier (n = 195)   Age (years)  46 ± 16 (35–57)   Sex (male:female)  60:135   Maximal diameter on 2D TTE (mm)  15.5 ± 5.4 (11.0–19.0)   Maximal diameter on 2D TOE (mm)  16.9 ± 5.6 (12.0–21.0)   Maximal diameter on 3D TOE (mm)  16.2 ± 5.6 (12.0–20.0)   Minimal diameter on 3D TOE (mm)  12.0 ± 4.8 (9.0–15.0)   Averaged diameter on 3D TOE (mm)  14.1 ± 5.0 (10.0–18.0)   Area on 3D TOE (cm2)  1.7 ± 1.2 (0.8-2.4)   Estimated device size by formula (mm)  19.2 ± 5.7 (15.0–24.0)   Device size implanted (mm)  19.3 ± 5.8 (15.0–24.0)   Device waist area (cm2)  3.2 ± 1.8 (1.8-4.5)  First tier (n = 53)   Age (years)  47 ± 15 (41–55)   Sex (male:female)  14:39   Maximal diameter on 2D TTE (mm)  15.9 ± 5.5 (12.0–19.8)   Maximal diameter on 2D TOE (mm)  17.8 ± 5.8 (13.5–21.5)   Maximal diameter on 3D TOE (mm)  17.2 ± 5.7 (13.0–20.5)   Minimal diameter on 3D TOE (mm)  12.6 ± 4.5 (9.5–15.0)   Averaged diameter on 3D TOE (mm)  14.9 ± 4.9 (11.5–18.3)   Area on 3D TOE (cm2)  1.9 ± 1.2 (1.0–2.6)   Estimated device size by formula (mm)  20.2 ± 5.5 (16.0–24.0)   Stretched balloon diameter (mm)  18.9 ± 5.5 (15.0–23.0)   Device size implanted (mm)  19.7 ± 6.0 (15.5–24.0)   Device waist area (cm2)  3.3 ± 2.0 (2.0–4.5)  Second Tier (n = 195)   Age (years)  46 ± 16 (35–57)   Sex (male:female)  60:135   Maximal diameter on 2D TTE (mm)  15.5 ± 5.4 (11.0–19.0)   Maximal diameter on 2D TOE (mm)  16.9 ± 5.6 (12.0–21.0)   Maximal diameter on 3D TOE (mm)  16.2 ± 5.6 (12.0–20.0)   Minimal diameter on 3D TOE (mm)  12.0 ± 4.8 (9.0–15.0)   Averaged diameter on 3D TOE (mm)  14.1 ± 5.0 (10.0–18.0)   Area on 3D TOE (cm2)  1.7 ± 1.2 (0.8-2.4)   Estimated device size by formula (mm)  19.2 ± 5.7 (15.0–24.0)   Device size implanted (mm)  19.3 ± 5.8 (15.0–24.0)   Device waist area (cm2)  3.2 ± 1.8 (1.8-4.5)  TOE, transoesophageal echocardiography; TTE, transthoracic echocardiography. Based on these first-tier results, we decided to select optimal device size by rounding off the calculated value using our formula. As the sizes of the Amplatzer device increase by 2 mm in devices above 20 mm, we selected right upper numerical values if the results of formula gave odd numbers above 20 mm, e.g. if the result of formula was 21 mm than we used 22 mm size of device. The optimal device size determined by the method described above was 20.2 ± 5.5 mm. The device size that was finally implanted after the balloon sizing procedure was 19.7 ± 6.0 mm. There was an excellent correlation between the optimal device sizes and the sizes of the devices finally implanted (R = 0.961, P < 0.001, Figure 2A). The device sizes estimated using our formula were larger than the device sizes finally implanted by a mean difference of 0.38 ± 1.5 mm (P < 0.001). This difference must be caused by stretched balloon sizing results, and there were some who were upsized and some downsized as shown in Figure 2A. However, the mean difference was not large enough to result in changing the device size that validated clinical feasibility of our formula. Figure 2 View largeDownload slide Correlations and Bland–Altman plots between estimated device size and device size finally implanted (A) and between estimated device size and stretched balloon diameter (SBD) in the first tier (B). On the correlation graphs, solid lines represent lines of identity, and dashed lines represent linear regression. On the Bland–Altman plots, solid lines represent average differences, and dashed lines represent average difference ± 1.96 standard deviation of the difference. Figure 2 View largeDownload slide Correlations and Bland–Altman plots between estimated device size and device size finally implanted (A) and between estimated device size and stretched balloon diameter (SBD) in the first tier (B). On the correlation graphs, solid lines represent lines of identity, and dashed lines represent linear regression. On the Bland–Altman plots, solid lines represent average differences, and dashed lines represent average difference ± 1.96 standard deviation of the difference. There was a significant correlation between the estimated device sizes and stretched balloon diameters (R = 0.929, P < 0.001, Figure 2B). However, the stretched balloon diameter could not be appropriately measured in some patients with large ASD, because the balloon position was not stable and the waist of balloon could not be clearly visualized. The stretched balloon diameters might have been underestimated due to this technical difficulty, and device size determination was more reliant on using 3D TOE images in those patients. Furthermore, the estimated sizes derived by our formula were odd number above 20 mm, and right upper numerical values were selected in 12 cases. Consequently, the stretched balloon diameter was smaller than the estimated device size by an average of 1.30 mm. In the second tier, 195 patients underwent transcatheter device closure of ASD without the balloon sizing procedure. Of these, 193 (99.0%) patients showed procedural success. The device size derived from the formula was used in all patients, with the exception of one patient (Figure 3). That patient showed a deficient rim on the aorta and superior sides, and the ASD was not on a single plane. The septum primum was attached on the left atrial side more than the septum secundum. The device of the estimated size could not be implanted securely; consequently, a larger sized device was successfully implanted. Figure 3 View largeDownload slide TOE images of the patient who underwent the procedure with a larger sized device than estimated by the formula. Red arrowheads represent the septum primum attached on the left atrial side more than the septum secundum. Figure 3 View largeDownload slide TOE images of the patient who underwent the procedure with a larger sized device than estimated by the formula. Red arrowheads represent the septum primum attached on the left atrial side more than the septum secundum. There were two cases of procedural failure with embolization of the device. In one patient, the device was successfully retrieved using a gooseneck snare, and surgical repair of ASD was performed. The other patient underwent emergent surgery for device retrieval and ASD closure. After reviewing the images for these two patients, we determined that they might not have been good candidates for percutaneous device closure. One patient showed tunnel-shaped ASD resembling the shape of patent foramen ovale, which was not on a single plane. The septum primum was attached to the left atrial side more than the septum secundum (see Supplementary data online, Figure S1). In the other patient, the interatrial septum showed aneurysm and elliptical ASD located along the margin of the aneurysm (see Supplementary data online, Figure S2). Of the second-tier patients with successful procedures, one patient presented with chest pain and dyspnoea the day following the intervention. Transthoracic echocardiography showed haemopericardium. This patient underwent emergent open-heart surgery, and erosion of the left atrial wall and adjacent aorta by a sharp left atrial device disc was revealed. The erosion was repaired, and ASD was closed using pericardium. The patient was discharged without any further complications 7 days after surgery. There were no procedure-related deaths. During the median follow-up period of 9 months (range 5–19 months) for 192 patients without in-hospital complications, another patient in the second tier underwent open-heart surgery at 19 days after ASD closure due to haemopericardium caused by right atrial posterior wall laceration by the device disc. In 10 patients (4 in the first tier and 6 in the second tier), a special assisted balloon technique using a supporting balloon inflated in the left atrium was implemented to secure the position of the device upon deployment because the standard deployment procedure failed.19 In these patients, the maximum diameter of ASD on 2D images was 24.0 ± 6.2 mm and on 3D TOE was 23.2 ± 6.0 mm. The size of the device finally implanted was 27.8 ± 7.3 mm. These patients showed a prolonged procedure time (44.4 ± 21.3 min) due to implementing a supporting balloon technique. When these cases were excluded, the mean procedure time was shorter in the second tier compared with the first tier (19 ± 6 vs 33 ± 10 min, P < 0.001). Discussion Determining the device size for transcatheter closure of ASD using balloon sizing has been regarded as the gold standard. However, several studies have been conducted to obviate the need for balloon sizing during the intervention, as it is a time-consuming and cumbersome procedure and may also cause complications as described earlier. Wang et al.8 demonstrated the safety and feasibility of transcatheter closure of ASD without balloon sizing by comparing outcomes between patients who underwent the procedure with and without balloon sizing. However, selection of device size was arbitrary and depended on the maximal size measured from 2D TOE. If an appropriate imaging plane of the maximal diameter was missed, the maximal diameter might be underestimated. Zanchetta et al.17 demonstrated intracardiac echocardiography-guided transcatheter closure of ASD using two standardized orthogonal diameters and a complex mathematical geometric equation. However, the major limitation of this study was these orthogonal diameters might not be equal to the maximal and minimal diameters of ASD; therefore, the derivation of quantitative data from geometric assumptions could be a major limitation of that study. 3D TOE provides an en face view of the entire ASD and helps to evaluate the shape of ASD and measure the maximal and minimal diameters.20 In our previously study, we demonstrated that the relationship between balloon sizing and maximal diameters measured using TOE was influenced by ASD shape and size,18 which has been corroborated by other studies.21,22 The mean difference between balloon sizing and the maximal diameter was higher in round ASDs than in oval ASDs. Therefore, ASD shape should be considered as well as size when determining device size without balloon sizing. From our previous study, we developed a formula for the relationship between the finally selected device size and 3D TOE parameters, and this equation was derived from our study including all of the diameters measured on 2D and 3D TOE, stretched balloon diameters, and finally selected device sizes that resulted in procedural success. Therefore, our formula differs from the formula suggested in another study, which demonstrated the relationship between balloon sizing and the maximal diameter on 3D TOE.22 In that study, ASD shape was not quantitatively evaluated and clinical utility of their formula for determining device size could not be validated. Our present study demonstrated that transcatheter closure of ASD with the device size determined by our formula using the 3D TOE images obtained before intervention and without balloon sizing was clinically useful and safe in most patients. In the first tier, we validated the decision about device size derived from our formula with a stretched balloon diameter and confirmed that this formula could be used in the second tier. We also found that the device size estimated using the formula was more reliable than the stretched balloon diameter in some patients with large ASD, as the balloon position was not stable and the waist of balloon could not be clearly visualized. The procedural success rate was 100% in the first tier, in which the device size was mainly determined by our formula using 3D TOE images. In the second tier, where balloon sizing was not used, the procedural success rate was 99.0%. However, there were two cases of device embolization after release of the device from the catheter. We subsequently found out that these cases were not good candidates for transcatheter closure, as presented in the Results, and procedural failure was caused by patient selection rather than a fault in our formula. These results suggest that patient selection is important, and our formula is clinically feasible and safe if used for patients with favourable ASD morphology suitable for transcatheter closure. As demonstrated in this study, the transcatheter closure of ASD using pre-determined device size based on 3D TOE images reduced the procedure time and helped to prevent potential complications caused by the balloon sizing procedure. Although our study population included some patients who did not have a favourable morphology of ASD, the procedural success rate in the second tier (99.0%) was superior or comparable to previous studies that demonstrated clinical feasibility of transcatheter ASD closure without balloon sizing procedures.8,9 Two patients in our study population experienced erosion of the left atrial wall and aorta or right atrial posterior wall by left or right atrial discs. Similar to our cases, there have been other case reports and reviews about atrial wall erosion after implantation of Amplatzer septal occluders.14,23,24 It is not certain whether this complication is due to deficient retroaortic or posterior rims, an under- or oversized device, geometry of the septum and aorta, or the matter of the device itself.25 The relationship between cardiac erosion and oversizing is controversial. According to survey to members of Congenital Cardiovascular Interventional Study Consortium, devices with lower risk of erosion are those that straddle the aorta, are somewhat oversized, while devices with higher risk are those with protruding left atrial disk into the aortic root, are somewhat undersized.26 We could not find any definite cause for this complication, as device size and position appeared appropriate after deployment, and the patients did not complain of any serious symptoms on the day of the intervention. Regular follow-up is necessary to determine whether this rare complication develops after the procedure, even for patients who underwent successful closure with the Amplatzer device. Our study has several limitations. First, unfavourable candidates for device closure could not be completely excluded from the study, which resulted in device embolization. However, these results allowed us to identify unfavourable morphologies of ASD and exclude those patients from further registry enrolment. We believe that procedural success rate will be improved with a more strict patient selection. Secondly, only Amplatzer septal occluders were used, and our results may not be simply extrapolated to other devices for transcatheter closure of ASD. Further studies will be needed to verify the clinical value of applying our method to other devices. Finally, in the second-tier cohort, there were higher rates of complications compared with a safety review of large population.26 A more strict patient selection considering unfavourable shape of ASD and rim deficiency would be needed for using our formula. Conclusions Transcatheter closure of ASD using the 3D TOE-derived formula without balloon sizing is clinically feasible and safe. However, caution should be taken to exclude patients with unfavourable features of ASD. Supplementary data Supplementary data are available at European Heart Journal - Cardiovascular Imaging online. Conflict of interest: None declared. References 1 Fischer G, Kramer HH, Stieh J, Harding P, Jung O. Transcatheter closure of secundum atrial septal defects with the new self-centering Amplatzer Septal Occluder. Eur Heart J  1999; 20: 541– 9. Google Scholar CrossRef Search ADS PubMed  2 Karamlou T, Diggs BS, Ungerleider RM, McCrindle BW, Welke KF. The rush to atrial septal defect closure: is the introduction of percutaneous closure driving utilization? Ann Thorac Surg  2008; 86: 1584– 90; discussion 1590–1. Google Scholar CrossRef Search ADS PubMed  3 Majunke N, Bialkowski J, Wilson N, Szkutnik M, Kusa J, Baranowski A et al.   Closure of atrial septal defect with the Amplatzer septal occluder in adults. Am J Cardiol  2009; 103: 550– 4. 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Google Scholar PubMed  11 Alsaileek AA, Omran A, Godman M, Najm HK. Echocardiographic visualization of laceration of atrial septum during balloon sizing of atrial septal defect. Eur J Echocardiogr  2007; 8: 155– 7. Google Scholar CrossRef Search ADS PubMed  12 Kijima Y, Taniguchi M, Akagi T, Nakagawa K, Kusano K, Ito H et al.   Torn atrial septum during transcatheter closure of atrial septal defect visualized by real-time three-dimensional transesophageal echocardiography. J Am Soc Echocardiogr  2010; 23: 1222.e1225– 8. Google Scholar CrossRef Search ADS   13 Wallace S, Dohlen G, Holmstrom H, Lund C, Russell D. Cerebral microemboli detection and differentiation during transcatheter closure of atrial septal defect in a paediatric population. Cardiol Young  2014; 25: 237– 44. Google Scholar CrossRef Search ADS PubMed  14 Amin Z, Hijazi ZM, Bass JL, Cheatham JP, Hellenbrand WE, Kleinman CS. 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Google Scholar CrossRef Search ADS PubMed  Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/about_us/legal/notices)

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European Heart Journal – Cardiovascular ImagingOxford University Press

Published: Jun 19, 2017

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