Occlutech percutaneous patent foramen ovale closure: Safety and efficacy registry (OPPOSE)

Hildick‐Smith, David; MacCarthy, Philip; Melikian, Narbeh; Monaghan, Mark; Spence, Mark S.; MacDonald, Simon T.; Duke, Abdul; Kováč, Ján; McGregor, Andrew; Hilling-Smith, Roland; Gomes, Arionilson; Thomson, Catherine S.; Mullen, Michael; Morrison, Lindsay

doi:10.1016/j.ijcard.2017.07.058

Cited by 16 publications

(19 citation statements)

References 20 publications

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“…Aytemir et al described three patients (1.3%) who developed a supraventricular arrhythmia at FU using the Occlutech device . There were none in the study by Saguner et al and one (1.1%) in the study by Hildick‐Smith et al In the more recent trials, SVTs occurred between 0.6% and in 6.6% …”

Section: Discussionmentioning

confidence: 98%

“…Krizanic et al found a moderate residual shunt was present in 3.7% at 6 months FU . A more recent study by Hildick‐Smith et al described 100 patients that received the Occlutech device and found at least a moderate shunt of 20.7% at 6‐months FU …”

Section: Discussionmentioning

confidence: 99%

“…6,9,10 Aytemir et al described three patients (1.3%) who developed a supraventricular arrhythmia at FU using the Occlutech device. 11 There were none in the study by Saguner et al and one (1.1%) in the study by Hildick-Smith et al 8,15 In the more recent trials, SVTs occurred between 0.6% and in 6.6%. 6,9,10 In all studies, new onset SVTs were diagnosed according to patient's symptoms or during routinely physical examination or ECG at the outpatient clinics, making it hard to know the exact incidence.…”

Section: Arrhythmiasmentioning

confidence: 94%

“…In literature, the residual shunt rate after PFO closure ranges from 8% to 21%. [13][14][15] Little is known about the residual shunt rate when using the Occlutech device, especially at long-term FU. The Kaplan-Meier of cerebrovascular events after patent foramen ovale closure using the Occlutech device…”

Section: Residual Right-to-left Shuntsmentioning

confidence: 99%

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Percutaneous patent foramen ovale closure using the Occlutech Figulla device: More than 1,300 patient‐years of follow up

Snijder

Renes

Suttorp

et al. 2018

Cathet Cardio Intervent

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Objective: To evaluate the safety and efficacy of the Occlutech patent foramen ovale (PFO) device at long-term follow-up (FU).Background: The Occlutech device has been proven safe and effective six-months after percutaneous PFO closure. We describe the safety and efficacy after more than 1,300 patient-years of FU.Methods: All consecutive patients who underwent PFO closure between October 2008 and December 2015 were included. All complications were registered. Residual right-to-left shunt (RLS) was diagnosed using contrast transthoracic echocardiography and graded as minimal, moderate, or severe.Results: In total, 250 patients (mean age 53.5 AE 10.7 years, 46.8% female) underwent percutaneous PFO closure using the Occlutech device. Mean FU was 5.9 AE 1.8 years, a total of 1,345 patient-years. Transient ischemic attack (TIA) or stroke was the main indication for closure (89.6%). Implantation was successful in 100%, no major complications occurred. Minor complications were inguinal hematoma in 16 patients (6.4%), pericardial effusion without the need for intervention in one patient (0.4%) and a supraventricular tachycardia in one patient (0.4%). A moderate or large shunt at one-year follow up was present in 5.9%. A cerebrovascular vascular event occurred in 2.0% at 1-year FU (four TIA, one stroke) and in 7.4% at long-term FU (nine TIA, eight stroke). The total cerebrovascular event rate (TIA and CVA) was 0.02% per patientyear of FU, with a stroke rate of 0.01%. Conclusion:The Occlutech device appears to be safe at long-term FU with a very low annual cerebrovascular event rate and a low moderate to large shunt rate at 1-year FU. K E Y W O R D Spatent foramen ovale, percutaneous closure, stroke, transient ischemic attack

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Section: Discussionmentioning

confidence: 98%

Section: Discussionmentioning

confidence: 99%

Section: Arrhythmiasmentioning

confidence: 94%

Section: Residual Right-to-left Shuntsmentioning

confidence: 99%

See 2 more Smart Citations

Percutaneous patent foramen ovale closure using the Occlutech Figulla device: More than 1,300 patient‐years of follow up

Snijder

Renes

Suttorp

et al. 2018

Cathet Cardio Intervent

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“…Metal disk PFO occluders, such as Amplatzer PFO occluder and Occlutech are the most widely used devices because of their efficacy and safety …”

Section: Discussionmentioning

confidence: 99%

Superior vena cava–right atrium junction flow‐pattern post‐transcatheter closure of patent foramen ovale

et al. 2019

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Background The patent foramen ovale (PFO) occluder is a bulky metallic device. Its impact on the normal blood flow at the superior vena cava–right atrial (SVC‐RA) junction is not clear. Methods We examined SVC‐RA junction flow‐pattern using pulsed‐wave (PW) ultrasound Doppler in 21 patients (4 male, aged 52.7 ± 9 years) who underwent PFO device closure 4–120 months previously, in comparison with 21 age‐ and sex‐matched controls (4 male, aged 51 ± 8.5 years) with structurally normal hearts. Results Mean systolic flow velocity at the SVC‐RA junction was 60 ± 11 cm/s in the PFO closure group and 64 ± 17 cm/s in the control group (P = 0.27). Mean diastolic blood flow velocity at the SVC‐RA junction in those groups was 30 ± 8 and 35 ± 9 cm/s, respectively (P = 0.1).The mean systolic wave duration was 439 ± 52 ms in the PFO closure group and 422 ± 67 ms in the control group (P = 0.4). The mean diastolic wave duration was 320 ± 75 and 277 ± 88 ms, respectively (P = 0.12). Conclusion The study results show that transcatheter PFO closure does not affect the normal blood flow at the SVC‐RA junction.

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Surgical Explantation of an Amplatzer Device for Patent Foramen Ovale Closure in a Patient With Nickel Allergy: A Case Report

Kumar,

Aslam,

Cooper

et al. 2024

Clinical Case Reports

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Patent foramen ovale (PFO) closure using percutaneous devices, such as the Amplatzer occluder, is a common treatment for patients with a history of cryptogenic stroke or transient ischemic attack (TIA). Although generally well‐tolerated, some patients may develop adverse reactions to the device materials, particularly in the presence of a nickel allergy. Symptoms can include chest pain, rashes, and migraines, which may necessitate surgical removal of the device. In such cases, careful surgical planning and execution are essential to ensure successful outcomes and symptom resolution. We present the case of a 39‐year‐old female with existing PFO closure using an Amplatzer device, who developed severe, persistent atypical chest pain radiating to her upper extremities and occasional migraines 1 month after Amplatzer implantation. Patch testing confirmed a nickel allergy, prompting a referral to our service for surgical explantation of the device. The patient underwent Amplatzer device removal and reconstruction of the interatrial septum via sternotomy. The surgical technique involved meticulous excision of the device while preserving maximal septal tissue, allowing for primary closure of the interatrial septum without the need for a pericardial patch. Intraoperatively, significant scar tissue and inflammation were observed surrounding the device and atrial septal tissue, necessitating careful excision while preserving healthy tissue. The left atrial appendage was oversewn using a polypropylene suture for thromboembolism prophylaxis. Amniotic membrane allograft and autologous platelet‐rich plasma were applied to promote wound healing, with specialized suture tapes used for chest closure to avoid using stainless steel sternal wires (the most common alloy, 316 L surgical steel contains around 15% nickel) and minimize the risk of sternal complications. The patient tolerated the procedure well, with complete resolution of symptoms following device removal. At follow‐up, she reported improved exercise tolerance, enhanced quality of life, and was able to discontinue her pregabalin medication after 30 months of use (600 mg once daily). She returned to work with light duties 6 weeks postoperatively. This case highlights the importance of preoperative allergy testing to consider nickel allergy in patients before implanting devices such as an Amplatzer, as well as after considering de novo nickel sensitization as a potential cause when such symptoms develop after implantation. This case also highlights the value of surgical intervention in alleviating symptoms and optimizing patient outcomes in cases of device‐related complications.

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Occlutech percutaneous patent foramen ovale closure: Safety and efficacy registry (OPPOSE)

Cited by 16 publications

References 20 publications

Percutaneous patent foramen ovale closure using the Occlutech Figulla device: More than 1,300 patient‐years of follow up

Percutaneous patent foramen ovale closure using the Occlutech Figulla device: More than 1,300 patient‐years of follow up

Superior vena cava–right atrium junction flow‐pattern post‐transcatheter closure of patent foramen ovale

Surgical Explantation of an Amplatzer Device for Patent Foramen Ovale Closure in a Patient With Nickel Allergy: A Case Report

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