Closure of a secundum atrial septal defect in two infants with chronic lung disease using the Gore HELEX Septal Occluder.

Children with a secundum atrial septal defect are usually asymptomatic and are referred for elective closure after 3-4 years of age; however, in premature infants with chronic lung disease, bronchopulmonary dysplasia, or pulmonary hypertension, increased pulmonary blood flow secondary to a left-to-right atrial shunt, may exacerbate their condition. Closure of the atrial septal defect in these patients can result in significant clinical improvement. We report the cases of two premature infants with chronic lung disease, who underwent atrial septal defect closure with the Gore HELEX Septal Occluder and discuss the technical aspects of using the device in these patients and their clinical outcomes.

Helex device closure of multiple atrial septal defects.

OBJECTIVES: To describe the effectiveness of the Helex Septal Occluder (HSO) to close multiple atrial septal defects (mASDs). Background : Limited information is available describing closure of mASDs with the HSO. METHODS: A total of 28 patients who underwent closure of mASDs with the HSO were identified by retrospective review of our catheterization database between 2001 and 2012. Procedural details and follow up information were collected. RESULTS: Median age was 19.2 years, median weight 48 kg, with 10 (36%) patients weighing <25 kg. Indication for closure was RV enlargement (RVE) in all patients and additionally neurologic events occurred in 3/28 (11%). Median stop-flow diameter for the largest ASD was 14 (4-23) mm. One HSO was implanted in 21/28 (75%), 2 in 6/28 (21%), and 3 in 1/28 (4%). One embolization and one transient arrhythmia occurred with no sequelae. Immediate residual shunt was absent in 5/28 (18%), trivial in 15/28 (54%), small in 6/28 (21%), and moderate in 2/28 (7%). Of the 25 patients with ≥6 months follow-up (median 53 months), residual shunt was absent in 13/25 (52%), trivial in 5/25 (20%), and small in 7/25 (28%). RVE resolved in all but one patient with no other associated lesions and ≥6 months of follow-up. No patient with prior neurological event had recurrence at last follow-up. CONCLUSIONS: We conclude that closure of mASDs with ≥1 HSO is effective with a low complication rate. The ability of HSO devices to overlap or sandwich each other may facilitate safe implantation of multiple devices in smaller patients.

Percutaneous PFO closure for paradoxical stroke in 8-kg twins.

Patent foramen ovale (PFO) is a known risk factor for paradoxical embolus, especially in the presence of other risk factors such as hypercoagulable states or central lines. A PFO is a common incidental finding in infants and children. However, paradoxical emboli are not common in infants, and so PFO closure is rarely indicated in this age group. We present two cases of PFO closures in identical 8 kg twin boys with Hurler's syndrome who had central lines for planned bone marrow transplants, with embolic stroke in one. We discuss the treatment options as well as the specific challenges based on the patients' age, size, and diagnoses. We also discuss the technical aspects and safety of percutaneous PFO closure.

Role of Echocardiography in the Diagnosis and Interventional Management of Atrial Septal Defects.

This review centers on the usefulness of echo-Doppler studies in the diagnosis of ostium secundum atrial septal defects (ASDs) and in their management, both in children and adults. Transthoracic echocardiography can easily identify the secundum ASDs and also differentiate secundum ASDs from other kinds of ASDs, such as ostium primum ASD, sinus venosus ASD and coronary sinus ASD, as well as patent foramen ovale. Preliminary selection of patients for device occlusion can be made by transthoracic echocardiograms while final selection is based on transesophageal (TEE) or intracardiac (ICE) echocardiographic studies with optional balloon sizing of ASDs. TEE and ICE are extremely valuable in guiding device implantation and in evaluating the position of the device following its implantation. Echo-Doppler evaluation during follow-up is also useful in documenting improvements in ventricular size and function, in assessing the device position, in detecting residual shunts, and in identifying rare device-related complications. Examples of echo images under each section are presented. The reasons why echo-Doppler is very valuable in diagnosing and managing ASDs are extensively discussed.

Outcomes of Device Closure of Atrial Septal Defects.

Several devices have been designed and tried over the years to percutaneously close atrial septal defects (ASDs). Most of the devices were first experimented in animal models with subsequent clinical testing in human subjects. Some devices were discontinued or withdrawn from further clinical use for varied reasons and other devices received Food and Drug Administration (FDA) approval with consequent continued usage. The outcomes of both discontinued and currently used devices was presented in some detail. The results of device implantation are generally good when appropriate care and precautions are undertaken. At this time, Amplatzer Septal Occluder is most frequently utilized device for occlusion of secundum ASD around the world.

A remarkable case of late-onset biatrial bacterial endocarditis of the Gore HELEX septal occluder.

The HELEX septal occluder (W.L. Gore & Associates, Newark, DE, USA) is a popular closure device for patent foramen ovale (PFO) and secundum atrial septal defect (ASD). Composed of a versatile polymer and a wire frame, it has been used for nearly a decade. A 50-year-old African American man with a PFO repaired 5 years previously with the HELEX was admitted to our hospital with methicillin-resistant Staphylococcus aureus bacteremia. A transesophageal echocardiogram demonstrated large mobile vegetations on the left and right atrial aspects of the occluder. Cardiothoracic surgery was consulted for removal of the vegetations and device, but hesitated owing to concurrent foot osteomyelitis and concern for re-infection of a potential replacement device. The patient was persistently bacteremic, his course complicated by septic pulmonary and cerebral emboli, but eventually cleared his infection on antibiotic therapy. Seventy days since admission, the patient was discharged to a rehabilitation facility. The case illustrates that infection is possible years after PFO/ASD closure despite a theoretical neoendothelialization within 6 months of implantation. Furthermore, it accentuates the success of timely and aggressive medical treatment, thereby averting high-risk open cardiac surgery. .

An alien in the heart.

We report a case of a 38-year-old-man who presented with altered mental status. The patient was diagnosed with infective endocarditis (IE) originating from the GORE HELEX septal occluder device, which was placed 15 months earlier for symptomatic atrial septal defect. Brain imaging revealed shower emboli phenomena from the known IE. The patient developed hydrocephalus for which external ventriculostomy was performed. Improved neurological status warranted open heart surgery. The patient was later confirmed to be an intravenous drugs abuser, prejudicing IE. This case highlights the importance of meticulously monitoring patients with suspected high-risk behavior with an implanted intracardiac prosthetic device.

Current perspectives in percutaneous atrial septal defect closure devices.

In the last decade, percutaneous atrial septal defect (ASD) closure has become the treatment of choice in most clinical presentations of ASD. Percutaneous ASD closure has established procedural safety through operator experience and improved device structure and deliverability. There have also been advances in diagnostic capabilities. Devices have evolved from large bulky meshes to repositionable, minimal residual mesh content that easily endothelializes and conforms well to surrounding structures. Biodegradable technology has been introduced and will be closely watched as a future option. The evolution of ASD closure device usage in the last four decades incorporates development that minimizes a wide range of serious side effects that have been reported over the years. Complications reported in the literature include thrombus formation, air embolization, device embolization, erosions, residual shunts, and nickel hypersensitivity. Modern devices have intermediate to long term data with outcomes that have been favorable. Devices are available in multiple sizes with improved delivery mechanisms to recapture, reposition, and safely close simple and complex ASDs amenable to percutaneous closure. In this review, commonly used devices and deployment procedures are discussed together with a look at devices that show promise for the future.

Results of the U.S. Food and Drug Administration continued access clinical trial of the GORE HELEX septal occluder for secundum atrial septal defect.

OBJECTIVES: This report describes the immediate, 1-, and 5-year follow-up results of the U.S. Food and Drug Administration Continued Access clinical trial of the GORE HELEX Septal Occluder (W. L. Gore & Associates, Inc., Flagstaff, Arizona) for closure of secundum atrial septal defect. BACKGROUND: The trial was conducted between May 2003 and August 2006 to allow continued enrollment in a trial of the investigational device during review of data from the Pivotal Trial. Devices with hydrophilic coating on the expanded polytetrafluoroethylene to improve echocardiographic visualization were first used in this trial. METHODS: A total of 137 devices were implanted in 137 patients at 13 US institutions. Evaluations were scheduled at 1, 6, and 12 months for the initial trial and at 36 and 60 months for a later extension of the trial in those who consented to longer term evaluations. RESULTS: Twelve-month follow-up was completed on 122 of 126 patients with implantations, and 5-year follow-up on 83 of 95 patients who agreed to the trial extension. The overall clinical success rate was 96.7%, and the major adverse event rate 3.6%. Wire frame fractures were seen in 11.7% of patients with no clinical symptoms. A trivial, clinically insignificant leak was seen, or could not be ruled out, in 26.6% of patients at the 5-year evaluation, but no clinically significant leaks were seen. No patient experienced an erosion or sudden catastrophic event. CONCLUSIONS: The immediate, 1-, and 5-year follow-up outcomes of the Continued Access clinical trial continue to demonstrate that the GORE HELEX Septal Occluder is a safe and effective transcatheter occluder for repair of ostium secundum atrial septal defect.