Combined prospective United States clinical study data for the GORE<sup>®</sup> HELEX<sup>®</sup> septal occluder device

Rhodes, John F.; Goble, Jake

doi:10.1002/ccd.24987

Cited by 12 publications

(11 citation statements)

References 20 publications

(43 reference statements)

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“…Migration of the device along with erosion of the aorta during follow-up was detected in 18 out of 15,900 (0.12% or 1 in 1,000) ASO implantations in a US study 45 , 46 . A similar prevalence (37 out of 35,000, 0.11%, or 1 in 1,000) in ASO implants worldwide was noted 44 – 47 . The data were examined by the Review Board and AGA Medical (AGA 2006); these reviews indicated that the device erosion may be associated with over-sizing of the device and recommended that a device size more than 1.5 times the TEE/ICE diameter size of the ASD should not be used for closure of the defect.…”

Section: Ostium Secundum Asdssupporting

confidence: 69%

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Recent advances in managing septal defects: atrial septal defects

Rao

Harris

2017

F1000Res

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The purpose of this review is to discuss the management of atrial septal defects (ASD), paying particular attention to the most recent developments. There are four types of ASDs: ostium secundum, ostium primum, sinus venosus, and coronary sinus defects. The fifth type, patent foramen ovale—which is present in 25 to 30% of normal individuals and considered a normal variant, although it may be the seat of paradoxical embolism, particularly in adults—is not addressed in this review. The indication for closure of the ASDs, by and large, is the presence of right ventricular volume overload. In asymptomatic patients, the closure is usually performed at four to five years of age. While there was some earlier controversy regarding ASD closure in adult patients, currently it is recommended that the ASD be closed at the time of presentation. Each of the four defects is briefly described followed by presentation of management, whether by surgical or percutaneous approach, as the case may be. Of the four types of ASDs, only the ostium secundum defect is amenable to percutaneous occlusion. For ostium secundum defects, transcatheter closure has been shown to be as effective as surgical closure but with the added benefits of decreased hospital stay, avoidance of a sternotomy, lower cost, and more rapid recovery. There are several FDA-approved devices in use today for percutaneous closure, including the Amplatzer® Septal Occluder (ASO), Amplatzer® Cribriform device, and Gore HELEX® device. The ASO is most commonly used for ostium secundum ASDs, the Gore HELEX® is useful for small to medium-sized defects, and the cribriform device is utilized for fenestrated ASDs. The remaining types of ASDs usually require surgical correction. All of the available treatment modes are safe and effective and prevent the development of further cardiac complications.

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Section: Ostium Secundum Asdssupporting

confidence: 69%

“…Wire frame fractures were observed in 8% of patients. A more recent analysis of 435 patients in the USA revealed composite clinical success in 93% of patients at 12-month follow-up 44 . The Gore HELEX ® device is generally thought to be a suitable device for the closure of small to medium-sized defects.…”

Section: Ostium Secundum Asdsmentioning

confidence: 99%

Recent advances in managing septal defects: atrial septal defects

Rao

Harris

2017

F1000Res

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“…At 6 month follow‐up 368/400 GSO subjects and 253/271 HELEX subjects were evaluated for clinical defect status, total 621 subjects. The remaining 50 subjects failed to undergo 6 month echocardiography.…”

Section: Resultsmentioning

confidence: 99%

Use of the GORE® CARDIOFORM Septal Occluder for percutaneous closure of secundum atrial septal defects: Results of the multicenter U.S. IDE trial

Gillespie

Javois

Moore

et al. 2020

Cathet Cardio Intervent

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Objective To evaluate safety and efficacy of the GORE® CARDIOFORM Septal Occluder for percutaneous transcatheter closure of ostium secundum atrial septal defects. Background The GORE® CARDIOFORM septal occluder is a double‐disc, low profile, soft, conformable device, with distinct advantages over the GORE® HELEX® Septal Occluder. Methods Subjects were enrolled in this single arm prospective study from 21 U.S. sites, and followed for 3 years. Primary endpoint was 6 month composite clinical success, comprised of technical success (implantation and retention of device), closure success (normalization of right heart size), no 30 day serious adverse events, and no device embolization or reintervention. Secondary endpoints included technical success, procedure success (technical success and ≤ 2 mm residual shunt at procedure conclusion), closure success (clinically insignificant or no residual shunt), and safety (freedom from 30 day serious adverse events and 6‐month device events). Results Between October 2012 and May 2015, 50 pivotal and 350 continued access subjects underwent attempted transcatheter GORE® CARDIOFORM Septal Occluder implantation. Median age was 6.9 years, and mean static defect diameter 9.7 ± 3.1 mm. Device placement was achieved in 93.5% (374/400). Composite clinical success was 90.2% and clinical closure success was 98.8% at 6 months. Freedom from serious adverse events was 98.3% at 30 days, with no device embolizations or reinterventions through 6 months. Conclusions The GORE® CARDIOFORM Septal Occluder has high composite clinical success and safety, performing well in defects ≤17 mm by stop flow stretched diameter. Single, multifenestrated, and deficient retroaortic tissue defects were well represented and successfully treated.

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“…Gore & Associates, Flagstaff, AZ) are thought to have a low risk for erosion: their frame can splay around the aorta without exerting significant force toward the aortic root or atrial roof . Long‐term follow‐ups regarding the Gore Helex Septal Occluder have revealed neither erosion nor perforation . As there has been no such mid‐ or long‐term follow‐up data forthcoming on the updated version, the Gore Septal Occluder (GSO), we initiated this retrospective pediatric multicenter study to assess the GSO's clinical performance at midterm follow‐up (GSO in situ ≥12 months).…”

Section: Introductionmentioning

confidence: 99%

Multicenter midterm follow‐up results using the gore septal occluder for atrial septal defect closure in pediatric patients

Grohmann

Wildberg

Zartner

et al. 2016

Cathet Cardio Intervent

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Combined prospective United States clinical study data for the GORE^® HELEX^® septal occluder device

Cited by 12 publications

References 20 publications

Recent advances in managing septal defects: atrial septal defects

Recent advances in managing septal defects: atrial septal defects

Use of the GORE® CARDIOFORM Septal Occluder for percutaneous closure of secundum atrial septal defects: Results of the multicenter U.S. IDE trial

Multicenter midterm follow‐up results using the gore septal occluder for atrial septal defect closure in pediatric patients

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Combined prospective United States clinical study data for the GORE® HELEX® septal occluder device

Cited by 12 publications

References 20 publications

Recent advances in managing septal defects: atrial septal defects

Recent advances in managing septal defects: atrial septal defects

Use of the GORE® CARDIOFORM Septal Occluder for percutaneous closure of secundum atrial septal defects: Results of the multicenter U.S. IDE trial

Multicenter midterm follow‐up results using the gore septal occluder for atrial septal defect closure in pediatric patients

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Combined prospective United States clinical study data for the GORE^® HELEX^® septal occluder device