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J Thorac Cardiovasc Surg 1996;112:21-26
© 1996 Mosby, Inc.
SURGERY FOR CONGENITAL HEART DISEASE |
From the Department of Cardiovascular and Thoracic Surgery, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India.
Received for publication Sept. 11, 1995 revisions requested Nov. 6, 1995; revisions received Dec. 11, 1995 Accepted for publication Dec. 13, 1995. Address for reprints: Probal K. Ghosh, MCh, FRCSE, Chairman, Department of Cardiovascular and Thoracic Surgery, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Raebareli Rd., Lucknow, 226 014, India.
Abstract
Various devices for transcatheter ASD closure are undergoing clinical trials. Each new device claims advantages in terms of safety and efficacy over earlier devices. We report three cases in which a new investigational device—the Das angel wings—failed. Emergency operations were necessary for device retrieval and defect closure. The possible mechanisms of the event and the options in management are discussed with a review of literature on all devices. (J THORAC CARDIOVASC SURG1996;112:21-6)
Transcatheter closure of atrial septal defects (ASDs) was introduced two decades ago.
1 Four devices have been described so far. The devices have been associated with occasional failures necessitating their retrieval by transcatheter or surgical means and occasional complications such as device embolization and transient ischemic attacks.
In 1993 Das and colleagues 2 introduced a new device intended to decrease rates of failures and complications, and they used it successfully in a dog model. Recently an international clinical trial with this device was started. After a hospital ethics committee review was conducted for a monitored trial, six patients underwent implantation of the Das angel wings device at our center. The following criteria were used for patient selection: (1) a fossa ovalis ASD less than 20 mm as measured on echocardiography; (2) a left-to-right shunt of 1.5:1 or more in the absence of severe pulmonary arterial hypertension; and (3) absence of other intracardiac defects necessitating surgical correction. Informed consent was obtained from each patient. In three of these patients, the device was deployed successfully. Two patients made an uneventful recovery and were discharged 48 hours after the procedure. In the third patient transient complete heart block developed but resolved after 72 hours, and the patient was discharged after 1 week. No residual shunt was detected at immediate or follow-up echocardiography. All three patients are doing well at 3 to 6 months' follow-up, and none has had infective endocarditis.
We shall now describe three patients with acute failure of this device who required emergency surgical management. This is the first report of surgical management after failure of the angel wings device used for ASD closure.
Case reports
Case 1.
A 26-year-old woman with no symptoms was confirmed to have secundum ASD on echocardiography. Transvenous closure was attempted on February 26, 1995. A long 14F sheath shaped to enter the left atrium was placed in the right femoral vein and a 5F sheath was placed in the femoral artery for pressure measurements. Under fluoroscopic control, a balloon was used to measure the stretched diameter of the ASD. A 30 mm Das device was implanted to occlude the ASD. After the device was released, it slipped back into the right atrium. It was snared and retrieved up to the right common iliac vein but could be advanced no further. The device was left in this position. A second attempt was made from the left femoral vein with a 35 mm device. This too slipped into the right atrium. At an emergency operation, the device was easily identified and removed after the right atrium was opened. The ASD was closed by direct sutures. The patient was weaned uneventfully from cardiopulmonary bypass. Through a vertical incision in the right groin, the other device was removed from the right common iliac vein. The vein was then directly repaired. The patient recovered without complications and was discharged on the sixth postoperative day.
Case 2.
A 23-year-old woman with secundum ASD underwent transcatheter closure on April 25, 1995. A 40 mm Das device was inserted via the right femoral vein. The device was successfully implanted, but within seconds of implantation it slipped into the left atrium. It could not be retrieved by being snared. The woman was in hemodynamically stable condition when taken for an emergency operation to retrieve the device and close the defect. The device was seen in the left atrium through a 2 cm ASD with a nonfibrous inferior margin. The device was retrieved through the ASD and the defect was closed directly. The patient made an uneventful recovery and was discharged. She remains well at 2 months' follow-up.
Case 3.
A 30-year-old woman with asymptomatic secundum ASD elected to undergo device closure of the ASD on April 26, 1995. A 35 mm Das device was used for implantation, but it could not be properly released. On a second attempt, after release of the second disc, it slipped into the left atrium. The patient's condition remained hemodynamically stable. At emergency operation the ASD, seen through a right atriotomy, was 1.6 cm in diameter with good margins. The device was easily identified lying in the left atrium and was removed through the defect. The ASD was closed primarily. The woman recovered without complications and was discharged on the seventh postoperative day. She is free of symptoms and doing well at 2 months' follow-up. The details of the echocardiographic, catheterization, and surgical findings of all three patients are given in Table I.
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Although the use of an ASD closure device was new for this institution, the principal investigators (who performed the procedures) are widely experienced in invasive procedures and have a high success rate with transcatheter ductus closure in this institution.
Discussion
ASD is the fifth most common congenital cardiac anomaly and occurs with a frequency of 3.2/10,000 live births. 3 It is being detected with even greater frequency because of the more widespread use of echocardiography. Surgical management of ASDs is safe and simple but is associated with occasional mortality, morbidity, and high expenses. Patent foramen ovale, with a prevalence at autopsy of 27% to 35%, 4 may cause paradoxic embolism 5 and necessitate surgical closure to prevent this complication. Interatrial communication after a fenestrated Fontan procedure may also indicate closure of the defect at a later date. With a view to decreasing the cost, hospital stay, and surgical complications, transvenous closure of these defects was introduced.
After the first report of such a device by King and associates 1 in 1976, several such devices were developed. Two devices (Lock clamshell 6 and Sideris buttoned device 7) have undergone clinical trials. Table II describes various devices and their main features. Table III is a brief review of the literature concerning use of these devices in various subgroups. All devices have been associated with instances of failure and complications (Table III). The clamshell device has been withdrawn and is undergoing further modifications.
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19 have described protocols for the selection of patients and devices. Rosenfeld and coworkers 17 described echocardiographic predictors of candidacy for successful transcatheter closure of these defects. They found that the success rate was only 59% in ASDs larger than 13 mm as compared with 100% in defects smaller than 13 mm. The other suggested mechanisms of acute failure are (1) operator-related failure resulting from inadequate experience (learning curve), (2) inaccurate deployment, (3) inadequate defect rim to hold the device, (4) tearing of the interatrial septum especially at the lower rim of the ASD owing to catheter and device manipulations, 20 and (5) the failure to button the Sideris buttoned occluder or unbuttoning of this occluder. 19 Chronic/late failure has been reported to result from unbuttoning and fracture of the wire framework of the Sideris device. 21 Various complications may occur. A part of the device or the whole device may embolize to the right or left atrium, main pulmonary artery, or even to other parts of the vascular tree on both the right and left sides of the circulation. 10-12,19,22 Thromboembolic episodes may occur as a result of poor endothelialization of these devices, necessitating long-term use of anticoagulants or even surgical removal of the device. 14 Other reports have described atrial perforation and hemopericardium. 19 Atrial arrhythmia and atrioventricular valve regurgitation may be caused by the device impinging on the atrial tissue or atrioventricular valves. Also, a high rate of residual shunt has been reported with the use of these devices. In the cumulative global experience (with all types of devices) in nearly 900 patients, the device failure rate is about 5% and the complication rate is 9%. Surgical intervention has already been performed in 4% for complications and failure, and another 4% will undergo operations for device failure.
Das and associates 2 developed their new device with the intention of reducing these failures and complications. The nitinol wire framework at the periphery of the Dacron fabric disc serves to keep the edges of the discs in close apposition to the atrial septum, and the large central connection between the two discs is supposed to reduce the tendency of the device to move along the atrial septum, potentially reducing the device/defect ratio. A special delivery system was designed to permit precise and reliable deployment of the device. The device has been successfully used in animal models, and clinical investigations were started in 1995.
The management of failures and complications usually involves snaring and transcatheter retrieval of the device with later surgical closure of the defect. However, if the device cannot be retrieved or causes complications (e.g., device embolization or atrial perforation) posing an emergency, prompt surgical management is required. In some instances in which the device is not obstructing any cardiac valve or vessel lumen, with a small and self-limiting atrial leak, and a stable hemodynamic state, the patients may be regularly followed up until elective surgical closure of the defects.
Although devices are useful alternatives to surgical closure in selected cases, they are not without attendant failures and complications. The state-of-the-art devices have not yet proven to be superior to presently available devices. Thus a proper selection of patient and device is required. Close monitoring and facilities for emergency surgical management should be available for all patients while an experienced operator deploys the device across the interatrial communication. Use of the devices is currently indicated in patients who have small defects with a patent foramen ovale and paradoxic embolism, interatrial communications after a fenestrated Fontan operation, and in children and adults who cannot undergo a surgical procedure. Use of these devices may buy time in some and may avoid surgery altogether in others.
Acknowledgments
Contributions to patient care by the staff of the Departments of Cardiovascular and Thoracic Surgery, Cardiology, and Anesthesiology and by Professor Das are acknowledged.
References
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