Figulla PFO occluder versus Amplatzer PFO occluder for percutaneous closure of patent foramen ovale

Saguner, Ardan M.; Wahl, Andreas; Praz, Fabien; Marchi, Stefano F. de; Mattle, Heinrich; Cook, Stéphane; Windecker, Stephan; Meier, Bernhard

doi:10.1002/ccd.22737

Cited by 19 publications

(16 citation statements)

References 48 publications

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“…The complication rate after percutaneous PFO closure with the Occlutech device varies between 0% and 15% . Krizanic et al described successful percutaneous PFO closure in 35 patients without any major complications .…”

Section: Discussionmentioning

confidence: 99%

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: 99%

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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“…Few studies on PFO closure were performed using the Occlutech Figulla ® devices, and to our knowledge no reports on the third generation Figulla ® Flex II PFO Occluder are available [15, 18–20, 22–24]. …”

Section: Discussionmentioning

confidence: 99%

“…Other formerly reported complications such as device embolization or intraprocedural TIA did not occur as well [20]. All patients were initially treated with the same combination of anti-platelet therapy in form of aspirin 100 mg/die and clopidogrel 75 mg/die.…”

Section: Discussionmentioning

confidence: 99%

“…Considering sufficient closure to be defined as no or only minimal residual right-to-left shunting, we were able to reach high sufficient closure rates using the Figulla ® Flex II PFO Occluder when comparing our results to former studies: Using the Amplatzer TM device Maier et al reported sufficient closure in 95.9 % in the PC Trial and Carroll et al 93.5 % in the RESPECT Trial, while sufficient closure was achieved in only 86.1 % in the CLOSURE I Trial studying the STARFlex ® device [9–11]. In previous studies using earlier generation Figulla ® PFO devices closure rates between 83 and 97 % were reached [18, 20, 23]. …”

Section: Discussionmentioning

confidence: 99%

“…Another unique characteristic of the Figulla ® devices is the flexibility of the occluder device, which can be angled independently from the angle of the delivery system due to a ball-socket joint connection. This enables a preferred occluder placement prior to release of the occluder even under difficult anatomic circumstances [19, 20]. Like previous Occlutech Figulla ® devices the Figulla Flex II has a single layer left atrial disc and only one right atrial hub (Fig.…”

Section: Introductionmentioning

confidence: 99%

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Mid-term results of interventional closure of patent foramen ovale with the Occlutech Figulla® Flex II Occluder

Neuser

Akin

Bavendiek

et al. 2016

BMC Cardiovasc Disord

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BackgroundPatients with a patent foramen ovale (PFO) who suffered from stroke, TIA or peripheral paradoxical embolism are at substantial risk for recurrent neurologic events and in need for secondary prevention. Interventional closure of PFO has been performed for over 20 years. Numerous devices have been developed and used for treatment. We investigated PFO closure with the third generation Occlutech Figulla® Flex II Occluder device.MethodsBetween 2012 and 2015 57 patients (mean age 47.3 ± 1.5 years) who had suffered from a thromboembolic event of unknown cause underwent transcatheter PFO closure with the Occlutech Figulla® Flex II Occluder at our department. 68.4 % of all patients had suffered from cryptogenic stroke, while TIA had occurred in 28.1 %. Almost all patients were diagnosed with an atrial septum aneurysm (90.9 %) and a severe right-to-left shunt grade 3: >20 microbubbles (92.0 %). Follow-up was done 6 months post intervention by clinical examination and transesophageal contrast echocardiography.ResultsNo major periprocedural or in-hospital complication occurred. Closure was sufficient with no residual right-to-left shunt in 94.4 % of all patients at 6 months post implantation and only minimal residual shunt in three cases. There were no thrombotic formations associated to the occluder device. Atrial fibrillation occurred in one patient and a recurrent cerebral ischemic event was seen in one patient, who suffered from another TIA.ConclusionsThe Occlutech Figulla® Flex II Occluder device and its delivery system is safe and provides sufficient closure of PFO in patients who suffered from cryptogenic stroke, TIA or paradoxical peripheral embolism.

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Device closure of patent foramen ovale—Do similar devices achieve similar results?

Kimmelstiel

2011

Cathet Cardio Intervent

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Patent foramen ovale (PFO) has been implicated in the pathogenesis of stroke and migraine. Although randomized trials have not, as of yet, reiterated the salutary effects on stroke and migraine seen in observational and case controlled studies, there doubtless exist a segment of the PFO population that benefit from percutaneous PFO closure.In this issue of CCI, Saguner et al., report an interesting study comparing the Figulla PFO occlusion device (FPO) with the Amplatzer PFO occluder (APFO) [1]. Employing a single-center, case control comparative design, the authors compared 20 patients receiving the FPO implanted for prevention of recurrent paradoxical embolism to 20 patients previously receiving an APFO, presumably for the same indication. Although specifically not stated, the comparison of the two devices was performed to assess acute and longer-term differences as relates to device performance and residual cardiac shunting following PFO closure. There were trends suggesting diminished procedural success and more periprocedural complications in the FPO group. The FPO patients demonstrated significantly more residual shunts with two patients undergoing additional device implantation with Amplatzer occluders.

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Figulla PFO occluder versus Amplatzer PFO occluder for percutaneous closure of patent foramen ovale

Abstract: According to this single-center case-control study, PFO closure with the FPO appears less efficacious than with the APFO.

Cited by 19 publications

References 48 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

Mid-term results of interventional closure of patent foramen ovale with the Occlutech Figulla® Flex II Occluder

Device closure of patent foramen ovale—Do similar devices achieve similar results?

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