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J Thorac Cardiovasc Surg 2007;134:946-951
© 2007 The American Association for Thoracic Surgery

Surgery for Congenital Heart Disease

Intraoperative device closure of secundum atrial septal defect with a right anterior minithoracotomy in 100 patients

^a Department of Cardiovascular Surgery, Shandong Provincial Hospital, Shandong University, Jinan, China
^b Department of Ultrasonics, Shandong Provincial Hospital, Shandong University, Jinan, China
^c Department of Internal Medicine, Shandong Tumor Hospital, Jinan, China.

Received for publication January 24, 2007; revisions received April 24, 2007; accepted for publication May 2, 2007.

^_* Address for reprints: Li Hongxin, MD, Department of Cardiovascular Surgery, Shandong Provincial Hospital, Shandong University, No. 324 Jingwu Road, Jinan 250021, China. (Email: hongxinli{at}hotmail.com).

	Abstract

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Objective: This study aims to report our experience using intraoperative device closure of secundum atrial septal defects and to evaluate the feasibility and clinical outcome of this technique.

Methods: One hundred patients with secundum atrial septal defects (mean age, 29 ± 16 years; age range, 5–71 years; mean weight, 54 ± 18 kg; weight range, 16–94 kg) underwent intraoperative device closure through a right minithoracotomy without cardiopulmonary bypass and fluoroscopy. A 2.5- to 3-cm parasternal or submammary incision was made in the right third or fourth intercostal space. Exposed with a miniretractor, a specially designed plastic sheath loaded with the device was inserted through the purse-string sutures placed on the right atrium. Under transesophageal echocardiographic guidance, it was advanced through the atrial septal defect into the left atrium, and the device was deployed in place.

Results: The procedure was successful in all patients, including 5 patients with double atrial septal defects. The maximum diameter of the atrial septal defect ranged from 5 to 37 mm (mean, 21 ± 7 mm). There were 61 patients with an atrial septal defect diameter of more than 20 mm, 16 of them with a diameter of more than 30 mm. The mean size of implanted devices was 25 ± 7 mm (range, 8–36 mm). Residual shunts were found in 9 (9%) patients immediately after the operation. The complete occlusion rate was 95% at discharge, 99% at the 3-month follow-up, and 100% at the 1-year follow-up. There were no other late complications during the follow-up period.

Conclusions: Intraoperative device closure is a safe, cost-effective, cosmetic, and less-invasive operation of most secundum atrial septal defects. Follow-up results are encouraging. It can be considered an acceptable alternative to transcatheter closure or surgical repair.

	Introduction

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Dr Hongxin

Surgical closure has been considered the gold standard treatment for patients with secundum atrial septal defects (ASDs) for many years. However, it is associated with morbidity, discomfort, and an unsightly scar.¹ Although technological advances, such as minimally invasive surgery, have been made with excellent results,² operative trauma still occurs and cardiopulmonary bypass (CPB) is still needed. CPB is widely recognized as having a number of adverse effects.³

In 1976, King and colleagues⁴ performed the first transcatheter occlusion of a secundum ASD in a patient. Since then, transcatheter closure of ASD has been increasingly improved and is becoming an effective alternative to surgical intervention.⁵ But the costs of this technique are much higher than those of surgical intervention in third-world countries,⁶ and it still has been associated with occasional serious complications. Surgical back-up is often needed.^7,8

We describe an intraoperative device closure (IODC) of secundum ASD, in which the defect was closed through a right minithoracotomy under transesophageal echocardiographic (TEE) guidance without CPB and fluoroscopy. It has less-invasive and better cosmetic results than has surgical repair. Like transcatheter closure, it is safe and much cheaper in third-world countries. This study reports our experience and current outcome with the application of this new technique.

	Materials and Methods

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Patients and Clinical Details
Between July 2001 and October 2006, 100 patients with a secundum ASD underwent ASD closure with septal occlusion devices through a right anterior minithoracotomy. All patients received diagnoses based on initial transthoracic echocardiography (TTE) and were considered for IODC. Among them, 39 were male, and 61 were female. The mean age was 29 ± 16 years (range, 5-71 years), and the body weight was 54 ± 18 kg (range, 16-94 kg). Twenty children less than 12 years of age were asymptomatic. Three patients were treated with IODC after an attempt at transcatheter closure failed.

Routine examinations before surgical intervention included standard electrocardiography (ECG), chest radiography, TTE, and blood tests. All patients were informed about IODC and consented to have the procedure. The ethics committee of our hospital approved this new technique.

Implantation of the Device
TEE
The patient was placed in a supine position after achievement of general anesthesia with a single-lumen tracheal intubation. TEE was performed to assess the defect and its surrounding rims at the time before the operation as part of the closure protocol.

The maximum longitudinal and horizontal diameters of the defect were measured in the standard TEE views to determine whether the ASD was round or elliptical. In patients with double ASDs, the size of the 2 defects, as well as the edge-to-edge distance between the communications, was measured. The superoposterior rim and the inferoposterior rim were measured as the superior vena caval (SVC) rim and inferior vena caval (IVC) rim, respectively. The rims from the margin of the defect to the aortic annulus (aortic rim), coronary sinus, atrioventricular valves, and right upper pulmonary vein was also measured. The total atrial septal lengths were obtained by using long-axis views of the atrial septum.

Patient inclusion criteria for IODC were as follows: (1) presence of a secundum ASD, including part of double ASD; (2) the rims from the above structures, except the aortic rim, must be 5 mm or larger, especially the IVC and SVC rims; (3) total length of the atrial septum not smaller than the diameter of the left disk of the chosen device; and (4) no other coexisting cardiac anomalies.

Device selection
The double-disk device is the same as that used in the transcatheter approach. A sizing balloon is not used in IODC. If the ASD is round or similar to round in shape, the device size is selected by adding 4 to 6 mm to the maximum ASD diameter. If the ASD is elliptical, the device is chosen with a size equal to or up to 4 mm larger than the maximum longitudinal diameter. As for double ASDs, the size is selected by adding 4 or 6 mm to the sum of the diameter of the larger defect and the edge-to-edge distance between the communications.

Operative technique
A 2.5- to 3-cm incision was made in the right anterior third or fourth intercostal space of the right sternal border. The exact location of the incision was chosen according to the chest film where the most prominent part of the right atrium was projected. For the female patients, a right submammary incision (Figure 1) was used within the "bikini lines." Exposure was optimized with a miniretractor. The pericardium was incised like an H and cradled with four 2-0 Ethibond (Ethicon, Inc, Somerville, NJ) stay sutures. Two parallel purse-string sutures of 4-0 or 5-0 Prolene (Ethicon, Inc) were placed on the right atrium, with a diameter of about 10 mm. Heparin was then administered at 1.0 mg/kg to achieve an activated clotting time of greater than 200 seconds at the time of device deployment.

View larger version (106K): [in this window] [in a new window]   Figure 1. A 2.5-cm right anterior submammary incision within the "bikini lines."

View larger version (43K): [in this window] [in a new window]   Figure 2. The delivery system includes a plastic sheath with a side arm and a delivery cable.

View larger version (97K): [in this window] [in a new window]   Figure 3. A, Under TEE guidance, the left atrial disk was extruded first, and the right atrial disk was deployed subsequently while traction was maintained on the delivery cable. B, The device was fully deployed across the ASD. TEE, Transesophageal echocardiography; ASD, atrial septal defect.

Patient Follow-up
After the operation, heparin was given to the patients for 24 hours (250 U/kg), and aspirin (3-4 mg · kg^–1 · d^–1) was continued for 4 months. All patients were instructed to use antibiotics and indomethacin for prophylaxis of bacterial endocarditis and postcardiotomy syndrome, respectively.

Follow-up examinations, including ECG and TTE, were scheduled at discharge and 3, 6, and 12 months and yearly thereafter.

Statistical Analysis
Data are expressed as means ± standard deviations and ranges.

	Results

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Intraoperative Results
Clinical demographic data of all patients are listed in Table 1. The maximum diameter of the ASD ranged from 5 to 37 mm (mean, 21 ± 7 mm). There were 45 patients with ASDs of 20 to 29 mm in diameter and 16 patients with ASDs of larger than 30 mm. Five patients had double defects, with the size of the larger defect ranging from 10 to 25 mm and the distance between the communications ranging from 3 to 8 mm.

Correct placement of the device at the first attempt was achieved in 82 (82%) patients. Redeployment of the device was necessary in 18 patients. In 10 of them, the device was replaced with a larger one because of the unstable position and residual shunt. In 8 patients the device was overestimated and needed to be changed with a smaller one. Two of them presented with myocardial ischemia on ECG immediately after the first deployment because of obstruction of the coronary sinus, 3 were found to have encroachment of the device on the movement of the mitral valve, and the final 3 were those in whom the devices appeared bulky because of the inaccurate measurements of TEE. No conversion from the IODC to conventional surgical intervention was required.

Postoperative Results
Seventy-five percent of the operations were accomplished within an hour. The average intracardiac manipulation time was 15 ± 13 minutes (range, 2-45 minutes). The patients were extubated on the operating table or within 2 hours in the recovery room.

Hydrothorax was noted in 3 patients, and removal of the pleural effusion was undertaken subsequently. Temporary sinus bradycardia was found in 12 patients, who were easily treated medically. Ninety-seven (97%) patients did not require any blood products. Blood loss occurred in 3 early cases because of lack of experience. Postoperative length of stay was 3 to 4 days, except for 3 patients with hydrothorax.

The total follow-up period ranged from 2 to 60 months (mean, 25 ± 17 months). The follow-up results were available by means of TTE in 100 patients at 3 months, in 94 patients at 6 months, in 81 patients at 1 year, in 59 patients at 2 years, and in 35 patients at more than 4 years. Residual shunts were found in 9 (9%) patients immediately after the operation. Four were trivial, 3 were small, and 2 were moderate.⁹ The complete occlusion rate was 95% at discharge, 99% at 3 and 6 months, and 100% at or after the 1-year follow-up. There was no incidence of device malposition, embolization, or other late complications. All patients or their guardians were pleased with their cosmetic results.

	Discussion

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Surgical closure has been considered a standard technique for patients with ASDs since the 1950s. This method was performed with a very low morbidity and no mortality and yielded optimal long-term results.^1,2,10 However, operative trauma and an unsightly scar can cause psychological distress in patients. Although current minimally invasive approaches have been applied with better cosmetic results,² the restrictive exposure of the heart turns a simple and safe operation into a technically difficult procedure that entails potential risks, such as injury to the great vessels and air embolism. Moreover, these techniques are just intended to make the skin incision less prominent; CPB and its deleterious effects still exist.³

Since the first clinical trials with the Amplatzer septal occluder (AGA Medical Corp) in the 1990s,¹¹ many favorable results compared with those of conventional surgical closure have been reported. These include superior cosmetic results, less trauma, avoidance of CPB, and a shorter hospital stay.^5,12 However, this technique still has been associated with occasional serious complications, such as device embolization, vessel injury, and even perforation of the heart.^7,8 Additionally, this technique needs more advanced equipment, and the costs are much higher than those of surgical intervention. This makes it difficult to popularize the use of this technique in developing countries,⁶ where health care resources are limited.

The advantages of IODC, when compared with those of surgical intervention, can be summarized as follows: CPB is not used, there is no need for a drainage tube and blood transfusion, and operative trauma is minimized. These might result in less pain, quick recovery, shorter hospital stay, and better cosmetic results.^13,14 Because of the right atrium not being opened and the special design of the delivery sheath, there is almost no probability of air embolism occurring during the procedure.

There are several theoretical advantages of IODC compared with those of the classic transcatheter procedure, which can be speculated as follows.

The first is that it is easier to guide the delivery sheath across the defect and anchor the device properly. In the process of IODC, the sheath approaches the ASD directly, and therefore the position of the left disk is easier to adjust with the short sheath than that of the transcatheter approach with a long delivery sheath, in which there is a right angle between the septum and the IVC. In patients with ASDs of a deficient rim, the surgeon can push the sheath by hand against the short rim and deploy the device in the proper position, which is unattainable in the transcatheter approach. In our series there were 61 patients with a defect of greater than 20 mm in diameter and 16 of them with a defect of greater than 30 mm. IODC was a success in all of them.

The second advantage is that more stability and feasibility of the device closure is available with IODC. Because the delivery cable is perpendicular to the atrial septum, the surgeon can test the stability of the device with more strength on it by using a push-pull maneuver after deployment. In addition, it is almost impossible to perforate the heart because no guide wires are used in IODC. Even if device embolization or perforation of the heart occurred, the patient could be saved immediately by extending the original incision for conversion to CPB surgery.

Third, in IODC there is no need for the complex long delivery system, including use of a balloon catheter and guide wires. There is no need for fluoroscopy and angiography. As with the transcatheter approach, IODC has the advantages of avoidance of CPB and intensive care unit stay, a short hospital stay, and no use of blood products. Because of its simplicity, only a short learning curve is required for surgeons, and less equipment is needed in this procedure compared with transcatheter closure. This leads to less resource use and reduced costs.

Lastly, transcatheter closure is more complicated in small children in whom the femoral sheath is prohibitively larger, whereas a larger device is needed. This would not happen in IODC unless the left atrium is too small or the surrounding rims of the ASD are deficient or absent.

TEE plays an important role in IODC.^14-16 IODC requires precise measurements of the size of an ASD, irrespective of its shape. This is important in choosing the device size. In patients with round or elliptical ASDs, we chose the device, respectively, with a diameter of 4 to 6 mm or 0 to 4 mm larger than the maximum diameter of the ASD. If an apparent residual shunt or a deformation of the disks occurred after deployment, the device should be retrieved and redeployed by exchanging it for a lager or smaller one.¹⁷

The other key feature in IODC is the surrounding rims of the ASD. A minimum of a 5-mm rim of atrial septum around the defect has been suggested as a prerequisite for device closure.^11,15,16 This minimal rim length is crucial for safe and stable positioning of atrial disks.¹⁷ Recent studies indicate^18,19 deficiency in the anterior superior rim did not influence the success rate of ASD closure with the Amplatzer device. The same result was obtained in our cohort. According to our experience, the most important rim is the IVC and SVC rim in IODC. The aortic rim is the least important and is usually absent in larger defects.

We had 5 patients with double defects who underwent successful closure with 1 device. In the literatures^15,20 the device must stent the larger defect, and the neighboring hole should be closed with lateral pressure or by covering with the left disk. The distance between the defects is an important factor. We chose the size of the device by adding 4 or 6 mm to the sum of the diameter of the larger defect and the edge-to-edge distance between the defects.

An additional consideration in IODC is the length of the interatrial septum, which should be sufficient to accommodate the device. Because the left disk is 12 to 14 mm larger than the waist, the size of the device added 12 to 14 should be less than the interatrial septal length.¹⁷ If there is not enough space for the configuration of the device within the left or right atrium, this can cause deformation of the device after deployment and sometimes encroachment on the mitral valve.

Residual shunt is a common complication in device closure of ASDs. Midterm follow-up of transcatheter closure of ASDs reports residual shunts in between 0% and 4% of patients.^5,19 Trivial or small residual shunts immediately after the release of the device need not be of too much concern.¹⁶ They usually disappear during the follow-up period.

Our study has several limitations. When discussing cost savings, no data are available comparing the costs between IODC and transcatheter closure. Our sample did not include small children, and we know that device closure in small children (<15 kg) is more challenging and complicated. Although we observed a complete occlusion rate of 100% and no serious complications occurred during the follow-up period, we still do not know whether the devices are safe in the very long term.

	Conclusions

Top Abstract Introduction Materials and Methods Results Discussion Conclusions References

 
IODC is a safe, cost-effective, cosmetic, and less-invasive operation of most secundum ASDs. Follow-up results are encouraging. It can be considered an acceptable alternative to transcatheter closure or surgical repair.

	References

Top Abstract Introduction Materials and Methods Results Discussion Conclusions References

 

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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Alert me to new issues of the journal Add to Personal Folders Download to citation manager Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Hongxin, L. Articles by Guidao, Y. Search for Related Content PubMed Articles by Hongxin, L. Articles by Guidao, Y.