Das Angel Wings Research Articles

Transcatheter Closure of Patent Foramen Ovale in Patients with Platypnea-Orthodeoxia: Results of a Multicentric French Registry

Dyspnea and the decrease in arterial saturation in the upright position in elderly subjects is described as platypnea-orthodeoxia syndrome (POS). POS is secondary to the occurrence of an atrial right-to-left shunt through a patent foramen ovale (PFO). This French multicentric study reports on 78 patients (mean age 67 +/- 11.3 years) with POS who had transcatheter closure of the PFO; frequently associated diseases were pneumonectomy (n = 36) and an ascending aortic aneurysm (n = 11). In all patients, the diagnosis was confirmed by transthoracic or/and transesophageal echocardiography. Five different closure devices were used: Amplatz (n = 45), Cardioseal (n = 13), Sideris (n = 11), Das Angel Wings (n = 8) and Starflex (n = 1). Closure was successful in 76 patients (97%). Oxygen saturation increased immediately after occlusion from 84.6 +/- 10.7% to 95.1 +/- 6.4% (p < 0.001) and dyspnea improved from grade 2.7 +/- 0.7 to grade 1 +/- 1 (p < 0.001). A small residual shunt was immediately observed in 5 patients (3 with the Cardioseal device, 1 with the Sideris and 1 with the Amplatz) leading to the implantation of a second device in one case (Cardioseal). Two early deaths occurred unrelated to the procedure (one due to sepsis probably related to pneumonectomy, another due to respiratory insufficiency). Other complications were: a small shunt between the aorta and the left atrium, two atrial fibrillations and a left-sided thrombus which disappeared with anticoagulant therapy. At a mean follow-up of 15 +/- 12 months, there were 7 late deaths related to the underlying disease. Percutaneous occlusion of the foramen ovale is safe and gives excellent results thanks to continuing improvement in available devices. This technique enables some patients in an unstable condition to avoid a surgical closure.

Five-year clinical and echocardiographic evaluation of the Das AngelWings atrial septal occluder*1

The late outcome of patients treated with atrial septal occluder devices remains incompletely defined. The purpose of this study was to assess the late outcome (range 4–7 years postprocedure) of patients in whom the Das AngelWings septal occluder device was implanted in the atrial septum. We report the clinical and echocardiographic outcome, at an average of 5 years following the procedure, of patients treated with the Das AngelWings device used to close either a secundum atrial septal defect (ASD) or a patent foramen ovale (PFO). Thirty-two patients underwent successful percutaneous closure of an atrial septal closure, patent foramen ovale, or fenestration in the lateral tunnel of their Fontan with the Das AngelWings device between June 1995 and March 1998 at Duke University Medical Center. Two of the 32 patients were lost to follow-up. The remaining 30 patients were divided into 3 groups based on indication for device implantation. Group 1 consisted of 14 patients with a secundum ASD and predominantly left-to-right atrial shunting. Group 2 consisted of 8 patients who had a PFO and who suffered a thromboembolic event. Group 3 (compassionate use) consisted of 10 patients with multiple comorbid medical problems with predominantly right-to-left shunting at the atrial level causing hypoxemia. Eight of the patients in group 3 were severely ill at the time of device implantation. The 2 remaining patients in group 3 underwent AngelWings implantation for closure of right-to-left shunting through a Fontan fenestration. Mean follow-up was 59 months. There was no device embolization. No patient in the ASD or PFO/stroke group had a clinical complication. By radiographic examination, 2 of 27 patients had evidence of fracture of the nitinol framework at 2-year follow-up. Residual shunting was present in 44% at 24 hours, 20% at 1 year, and 18.8% at 2 years by use of Doppler color flow imaging and/or microcavitation echocardiographic studies. Mild mitral regurgitation caused by the AngelWings device occurred in 1 patient. One patient in the compassionate use group had a subsequent neurologic event. Five of the 10 patients in the compassionate use group died of comorbid illnesses in follow-up, none directly related to device complications. The late clinical outcome of secundum ASD and PFO/stroke patients in this study demonstrates that Das AngelWings closure of the atrial septum is effective and safe. These data are encouraging with respect to the expanding use of other percutaneously implanted ASD occlusion devices, although late clinical safety and efficacy data are needed for the specific devices being implanted.

Five-year clinical and echocardiographic evaluation of the Das AngelWings atrial septal occluder

Background The late outcome of patients treated with atrial septal occluder devices remains incompletely defined. The purpose of this study was to assess the late outcome (range 4–7 years postprocedure) of patients in whom the Das AngelWings septal occluder device was implanted in the atrial septum. We report the clinical and echocardiographic outcome, at an average of 5 years following the procedure, of patients treated with the Das AngelWings device used to close either a secundum atrial septal defect (ASD) or a patent foramen ovale (PFO). Methods Thirty-two patients underwent successful percutaneous closure of an atrial septal closure, patent foramen ovale, or fenestration in the lateral tunnel of their Fontan with the Das AngelWings device between June 1995 and March 1998 at Duke University Medical Center. Two of the 32 patients were lost to follow-up. The remaining 30 patients were divided into 3 groups based on indication for device implantation. Group 1 consisted of 14 patients with a secundum ASD and predominantly left-to-right atrial shunting. Group 2 consisted of 8 patients who had a PFO and who suffered a thromboembolic event. Group 3 (compassionate use) consisted of 10 patients with multiple comorbid medical problems with predominantly right-to-left shunting at the atrial level causing hypoxemia. Eight of the patients in group 3 were severely ill at the time of device implantation. The 2 remaining patients in group 3 underwent AngelWings implantation for closure of right-to-left shunting through a Fontan fenestration. Mean follow-up was 59 months. Results There was no device embolization. No patient in the ASD or PFO/stroke group had a clinical complication. By radiographic examination, 2 of 27 patients had evidence of fracture of the nitinol framework at 2-year follow-up. Residual shunting was present in 44% at 24 hours, 20% at 1 year, and 18.8% at 2 years by use of Doppler color flow imaging and/or microcavitation echocardiographic studies. Mild mitral regurgitation caused by the AngelWings device occurred in 1 patient. One patient in the compassionate use group had a subsequent neurologic event. Five of the 10 patients in the compassionate use group died of comorbid illnesses in follow-up, none directly related to device complications. Conclusion The late clinical outcome of secundum ASD and PFO/stroke patients in this study demonstrates that Das AngelWings closure of the atrial septum is effective and safe. These data are encouraging with respect to the expanding use of other percutaneously implanted ASD occlusion devices, although late clinical safety and efficacy data are needed for the specific devices being implanted.

Microvena Atrial Septal Defect Occlusion Device ‐ Update 2000

This article (1) summarizes the Duke University results with the Das-Angel Wings atrial septal defect occlusion device, (2) outlines the rationale for design changes in the device, and (3) describes the new Microvena atrial septal defect occlusion device characteristics, and plans for the future. At Duke University, investigators using the first-generation device attempted closures in 35 patients with atrial level communications. Ages ranged from 5 to 83 years with a median of 28 years, and weights ranged from 16 to 100 kg. Thirty-two of the 35 defects had successful device placement. On follow-up, the defects of 27 of 32 patients with an implanted device were completely closed, and 5 patients had < 2-mm residual leaks. Three patients had malposition of the device, two of whom were treated surgically and one of whom was treated with percutaneous device retrieval. Complications included one small mitral valve perforation with no clinical sequelae. There have been no strokes, delayed embolizations, nor procedure or device related deaths. There have been no new or late problems in the cohort in a follow-up extending to 63 months. Opportunities for improvement of the device were noted during the clinical study. The manufacturer, Microvena Corporation, voluntarily withdrew the occluder for a redesign initiative. The objectives of redesign were ready deployment, reduction of device manipulation, rounding of the device, and retrievability. The Guardian Angel device has been the product of the redesign effort. It is a percutaneously inserted atrial septal defect occlusion device that uses the same materials as the initial device, but which has advantages of retrievability, repositionability, and no need for device manipulation. Initial studies have been performed in experimental animals, and clinical trials are planned for the near future.

Cierre percutáneo de la comunicación interauricular: resultados a medio plazo de esta nueva opción terapéutica

To evaluate the midterm results of percutaneous closure of the atrial septal defect using two new devices. Nine children (weight 19.7 +/- 7 kg, age 5.1 +/- 1.9 years) underwent percutaneous type II atrial septal defect closure through the antegrade pathway under general anaesthesia, and monitored by transesophageal echocardiography. The closing devices used were DAS-Angel Wings and Ampaltzer. The hemodynamic results were: mean diameter of the defects was 11.4 +/- 2 mm by TEE measurement and 12.3 +/- 2.6 mm using balloon occlusion reference. Mean pulmonary artery pressure was 12.7 +/- 2 mmHg and mean pulmonary vascular resistance 1.5 +/- 0.5 U/m2. A total of 13 devices were used: 9 Amplatzer and 4 DAS-Angel Wings. Four Amplatzer through the introducer were retrieved without complications. Two of which because of lack of sufficient stability in the atrial septum because they were too small inappropriate and the other two because of inappropriate expansion of distal disk of the device. Finally in all patients the device was a successfully deployed. The angiographic evaluation immediate post-procedure showed a minimal shunt in five patients that was no longer present by color Doppler echocardiography 24 hours later. The children were discharged 38 +/- 12 hours after the procedure and at a mean follow up of 9.6 +/- 2.2 months they remain asymptomatic without any clinical or technical problems. With the right selection of patients percutaneous closure of atrial septal defects can obtain a very high success rate without complications.

Transcatheter closure of a patent foramen ovale following mitral valve replacement

We report the successful closure of a postoperative patent foramen ovale in a patient who underwent coronary artery bypass grafting and mitral valve replacement for severe mitral insufficiency. The postoperative course was complicated by severe hypoxemia due to a large patent foramen ovale. The patient underwent transcatheter closure with the Das Angel Wings transcatheter occluder (Microvena Corporation, White Bear Lake, MN) with immediate improvement.

Echocardiographic characteristics of successful deployment of the Das AngelWings atrial septal defect closure device: initial multicenter experience in the United States

The AngelWings device is a newer transcatheter device used for closure of secundum atrial septal defects (ASD) and patent foramen ovale (PFO), which consists of a self-centering, 2-disk system. Transesophageal echocardiography (TEE) plays a pivotal role in the deployment of the 2 disks of this device, on the appropriate sides of the atrial septum. The objective of this study is to describe the echocardiographic findings associated with successful deployment of the AngelWings device for closure of ASD and PFO. We evaluated the TEE studies of 70 patients enrolled in 4 United States centers, for closure of ASD and PFO with the AngelWings device. The TEE characteristics of successful and unsuccessful deployments were analyzed. Residual shunts across the atrial septum were assessed by TEE at the end of the procedure, 24 hours later by transthoracic echocardiography, and at 6 months by TEE. The deployment of the device was successful in 65 patients (93%). In the unsuccessful group, ASD size by TEE was larger (13.4 ± 3.1 vs 8.9 ± 4.7 mm, p <0.05). TEE was successful in identifying snagging of the device by intracardiac structures and prolapse of corners of the left or right atrial disk through the ASD, features that were difficult to identify by fluoroscopy. The echocardiographic characteristics outlined here are important guidelines for successful deployment of the AngelWings device.

Transcatheter closure of atrial septal defects in children — initial experience with the Das Angel Wings device

The most critical issues in non-surgical closure of secundum atrial septal defects are device embolization, residual interatrial shunts, cardiac perforation, and patient selection criteria. This report reviews a three-center experience using the recently developed `Das Angel Wings ASD-occluder'. Between February 1996 and January 1997, 44 children underwent catheterization for closure of secundum atrial septal defects (ASD). The characteristics of the defects were evaluated by transesophageal echocardiography (TEE) and intracardiac balloon catheter sizing. With guidance from TEE and fluoroscopy, the self-centering double umbrella was introduced and deployed by transvenous approach in patients with defects ≤20 mm in diameter. The size of the device used was 1.5 times the size of the defect. Implantation was attempted in 26 patients with a balloon-stretched defect diameter of 11.0–19.5 mm, and it was successful in 23 of them. Eighteen patients were excluded because of one of several limiting criteria: additional cardiac defects in three patients, multiple interatrial fenestrations in four; an unsuitable size of the defect in relationship to atrial chamber dimensions in six; a defect size >20 mm in four; and an inadequate inferior septal rim in one. In three of the 23 patients with implantation, the device was removed surgically after suboptimal placement. After a 3-month follow-up, no device embolization was seen and only one patient had a significant residual interatrial shunt. Surgical removal of the device was necessary in one patient who had a late cardiac perforation with hemopericardium and in another patient with a persistently distorted device. In selected patients, transcatheter closure of secundum atrial septal defects is a feasible alternative to surgical correction. Transesophageal echocardiography is useful in identifying suitable defects with a high probability for successful device closure. The self-centering feature of this ASD-Occluder should diminish the risks of embolization of the device, enhance its transvenous implantation, and result in higher efficacy.

Clinical use of the ‘das-angel wings’ septal occluder device in children

Transcatheter closure of secundum type atrial septal defects is undergoing extensive clinical evaluation. In this paper, we review the application of the new Das-Angel Wings occluder device. This device consists of two square disks attached in the center via a conjoint ring. First we review the preselection protocol, based on transesophageal two and three-dimensional echocardiography. Then we review the specific device design, and delivery catheter. To date 24 patients with secundum atrial septal defect/patent foramen ovale associated with transient ischemic attacks have undergone closure. The initial results are encouraging, phase I has thus been completed and phase II is about to commence.

Failure of devices used for closure of atrial septal defects: Mechanisms and management

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 T horac C ardiovasc S urg 1996;112:21-6)

Utility of 3-D echocardiography in patient selection and guidance for Atrial Septal Defect (ASD) closure by the new das-angel wings occluder device

Utility of 3-D echocardiography in patient selection and guidance for Atrial Septal Defect (ASD) closure by the new das-angel wings occluder device