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(Circulation. 2003;107:795.)
© 2003 American Heart Association, Inc.
Brief Rapid Communications |
From the Divisions of Cardiology, Departments of Internal Medicine and Pediatrics, University of Essen, Essen, Germany.
Correspondence to Dr Thomas Bartel, Cardiology Division, Department of Internal Medicine, University of Essen, Hufelandstr. 55, 45122 Essen, Germany. E-mail thomas.bartel{at}uni-essen.de
| Abstract |
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Methods and Results Forty-four patients undergoing device closure of ASD (n=6) or PFO (n=38) were randomized to have the procedure guided by either ICE (group 1; n=22) or by transesophageal echocardiography (TEE) (group 2; n=22). All interventions were completed successfully. In 1 patient from group 2, atrial fibrillation occurred 1 day after device implantation; the patient was successfully cardioverted on the next day. There were no other complications. Fluoroscopy time (FT) (6.0±1.7 minutes versus 9.5±1.6 minutes; P<0.0001) as well as procedure time (PT) (33.4±4.7 minutes versus 37.8±5.6 minutes; P<0.01) were shorter in group 1 than in group 2. Group 2 patients required general anesthesia without (n=19) or with endotracheal intubation (n=3). In contrast, ICE allowed continuous monitoring of the whole procedure, including balloon sizing before device closure, without sedation.
Conclusions ICE is a safe tool to guide device closure of PFO and ASD. Supine patients tolerate ICE better than TEE. ICE reduces FT and PT. ICE seems to be advantageous, especially when long continuous or repeated echocardiographic viewing is required.
Key Words: heart septal defects catheterization echocardiography imaging
| Introduction |
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| Methods |
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1.5/1 were scheduled for transcatheter closure. All patients were randomized to either continuous guidance by ICE (group 1; n=22) or guidance using brief episodes of TEE monitoring (group 2; n=22).
Echocardiographic Guidance
For ICE, the 10 F AcuNav-catheter (Acuson-Siemens Inc) was inserted via an 11 F sheath and advanced through the inferior vena cava into the right atrium (RA).14,15 To permit adequate imaging of the interatrial septum (IAS) and its neighboring structures,16 2 standardized views were used: a longitudinal view showing the extent of the IAS from cranial to its distal margins (Figure 1a) and a perpendicular short-axis view to visualize the anterior part of the IAS and the transition to the ascending aorta (Figure 1b).
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Group 2 patients received 5 mg of midazolam intravenously before introduction of the TEE-probe and continuous intravenous propofol at a rate of 5 to 10 mg/h to maintain general anesthesia without endotracheal intubation. Patients who did not tolerate the probe under this regime were intubated. ICE and TEE were performed with a Sequoia 256 ultrasound unit (Acuson-Siemens Inc).
Device Closure Protocol
In group 1, access for the ICE catheter was from the left femoral vein. Stretch size of the PFO or ASD was measured using balloon catheters (Arrow Corp and AGA Medical Corp) and an Amplatzer closure device (AGA Medical Corp) deployed as reported.1,17 In group 1 patients, the procedure was primarily guided by ICE and was supplemented by fluoroscopy as needed. In group 2 patients, the procedure was primarily guided by fluoroscopy. To avoid endotracheal intubation, TEE was not employed in most patients until the ultimate phase of device closure. FT and PT were measured.
Statistical Analyses
Parametric data were expressed as mean±SD and tested with the unpaired 2-tailed Students t test for group distinction. Nonparametric data were tested employing the
2 test with one degree of freedom. A value P<0.05 was considered significant.
| Results |
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In group 1, no medication was required during the procedure. In 19 group 2 patients, TEE was tolerated without endotracheal intubation for 3 to 15 minutes (7.1±3.1), whereas 3 subjects needed to be intubated. In group 1, all diagnostic and most interventional stages could be completely guided by ICE (Figure 2a through 2f), including balloon sizing, unfolding of both countercluders, release of the device from the delivery cable, and the final check for adequate positioning and residual shunts. Other steps could be partially guided, eg, primary catheter passage of the interatrial communication and placement of the long sheath into the left atrium (LA). ICE image resolution was superior to that of TEE. ICE displayed specific details more clearly. The tip of the long sheath was clearly detectable when a wire was inside the sheath to facilitate adequate positioning, the occluder was observed not only during unfolding but also while being advanced through the sheath into the LA, and details of both countercluders and their spatial relation to the IAS and other structures were displayed (Figure 2f).
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FT and PT were shorter in group 1 than in group 2 (FT: 6.0±1.7 minutes versus 9.5±1.6 minutes, P<0.0001; PT: 33.4±4.7 minutes versus 37.8±5.6 minutes, P=0.0065). In group 1, FT and PT shortened throughout the course of the study, indicating a learning curve (Table). ICE monitoring reduced patient stress significantly.
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| Discussion |
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Limitations
The potential risks related to ICE could not be estimated at this time. In our experience, the risk potential is low and comparable to other invasive diagnostic tests. It is mandatory, however, that the ICE-catheter be handled with caution.16 The fact that the catheter is not wire-guided makes it different from conventional ultrasound catheters and may present a potential risk. Thus, fluoroscopy is generally recommended to position the steerable ICE catheter into the RA. Any potential risk must also be compared with the risk associated with brief intermittent TEE monitoring, including the risk of aspiration in supine patients. The criteria defining differences in image quality between the 2 modalities are descriptive; image quality and patient tolerance were not quantitated. In group 1, device guidance was mostly accomplished with ICE, whereas fluoroscopy was the primary technique in group 2, limiting the comparability of the procedures.
Conclusion
For guiding device closure of ASD and PFO, particularly when long continuous or repeated echocardiographic viewing is required or complications start to develop, ICE is superior to TEE. For the patient, procedural stress and radiation exposure are reduced, and the procedure is likely to become safer. Savings from shorter PT and from avoiding general anesthesia need to be weighed against the costs of the ICE catheter. After just a short learning curve, interventional cardiologists can fully benefit from the advantages of ICE.
| Acknowledgments |
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Received November 7, 2002; revision received December 31, 2002; accepted January 3, 2003.
| References |
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