Comparison of residual shunt rates in five devices used to treat patent foramen ovale

Matsumura, Koichiro; Gevorgyan, Rubine; Mangels, Daniel; Masoomi, Reza; Mojadidi, Mohammad K.; Tobis, Jonathan M.

doi:10.1002/ccd.25453

Cited by 30 publications

(25 citation statements)

References 25 publications

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“…Furthermore, generation of inadequate closing force by the Helex device introduces risk for device slippage and embolization postdeployment . Inability of the Helex device to hold itself against the septal wall may be responsible for the increased incidence of residual shunting observed in the 30 mm Helex device compared to the other 25 mm devices, consistent with findings by Matsumura et al To compensate for the inadequate clamping force associated with the earlier devices (prior to the release of the Cardioform device), interventionalists often chose the Amplatzer ASO device if balloon sizing yielded a PFO width > 12 mm. Both the Amplatzer PFO and Amplatzer ASO devices provide sufficient closing force, but given the stiffness associated with the nitinol mesh disks and the possibility of a nickel allergy, these devices have been shown to be associated with higher prevalence of chest pain, excessive scarring, and device erosion .…”

Section: Discussionsupporting

confidence: 78%

Comparison of residual shunt rate and complications across 6 different closure devices for patent foramen ovale

Fleming

Kumar

West

et al. 2019

Cathet Cardio Intervent

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Objectives To compare residual shunt rate and complications associated with six different devices used for PFO closure. Background Transcutaneous PFO closure is an effective treatment for preventing recurrent stroke in patients with a history of cryptogenic stroke. The rate of residual shunt is one metric by which the technical success of PFO closure can be measured. Methods Patients who underwent PFO closure at a single center between February 2001 and July 2019 were retrospectively enrolled in the study. Right‐to‐left shunt at baseline and during follow‐up was assessed using transcranial Doppler (TCD) or transthoracic echocardiography (TTE). Periprocedural and device‐related complications, including atrial fibrillation, were also assessed. Results Of 467 PFO closures performed during this period, 320 patients received quantitative assessment of right‐to‐left shunting both before and after percutaneous closure. The highest effective closure was achieved with the Cardioform device (100%, n = 104), followed by the Amplatzer Cribriform (93%, n = 14), Helex (90%, n = 137), Amplatzer ASO (88%, n = 17), CardioSEAL (86%, n = 14), and Amplatzer PFO (85%, n = 33) devices. The most common significant adverse event was atrial fibrillation, which was more common with the Cardioform device (13%) than the Helex (4%) or the Amplatzer PFO (4%) devices. Conclusions The Gore Cardioform Septal Occluder provides more robust closure of a PFO when compared to other devices but its effectiveness is offset by the higher prevalence of transient atrial fibrillation.

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Section: Discussionsupporting

confidence: 78%

Comparison of residual shunt rate and complications across 6 different closure devices for patent foramen ovale

Fleming

Kumar

West

et al. 2019

Cathet Cardio Intervent

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“…Recent case series have reported successful closure, with no residual shunting at follow-up in 75 % to 100 % of patients, which varied based on the device [45,46]. In most observational studies, the relationship between residual interatrial shunting and recurrent event rate was not consistent [47].…”

Section: Success Of Closurementioning

confidence: 91%

“…The device is currently under evaluation in a RCT evaluating its efficacy versus medical therapy for prevention of recurrent cerebrovascular events (the Gore REDUCE Clinical Study NCT00738894). Some observational data do suggest a higher rate of residual shunting with this device compared to other occlusion devices [46,54], while others have shown no difference [50].…”

Section: Amplatzer Pfo Occluder (St Jude Medical)mentioning

confidence: 96%

“…The device is non-absorbable. The Amplatzer PFO occluder was the device used in both the PC [8•] and RESP ECT trials [9•], and has shown reproducibility, an acceptable side effect profile, and a low residual shunt rate in observational studies [45,46,49,50,53,54]. Another trial evaluating the Amplatzer PFO occluder is ongoing (DEFENSE-PFO NCT01550588).…”

Section: Amplatzer Pfo Occluder (St Jude Medical)mentioning

confidence: 99%

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Role of Occlusive Devices to Prevent Thromboembolism Among Persons With a Patent Foramen Ovale and Prior Stroke

Roth

Alli

2015

Curr Treat Options Neurol

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Patent foramen ovale (PFO) has been linked to stroke, presumably through the mechanism of paradoxical embolism; however, data is confusing regarding the causal relationship between PFO and embolic stroke. What has come to light in the past decade of research is that PFO closure with devices that achieve a high rate of closure may reduce the risk of recurrent stroke compared with medical therapy, but this benefit has not been shown in the general population with a PFO and cryptogenic stroke. The important question now is which patient will benefit from PFO closure for stroke risk reduction. A validated risk prediction tool is needed to help physicians determine those patients who will derive benefit from closure of PFO to prevent recurrent stroke. It is clear that even in studies with a small number of individuals and a very small number of events, there is some benefit to closure. Furthermore, improvements in closure devices and techniques have made percutaneous device closure both safe and efficacious. As such, it is not necessary to wait for a patient to have two strokes prior to serious consideration of PFO closure. We would advocate that the decision to close a PFO in the setting of a cryptogenic stroke be made at an individual level, on a case-by-case basis. Patients with high-risk features may be more likely to benefit, though who exactly comprises this population is still being elucidated. The most difficult aspect of managing this disease is the substantial number of individuals with incidental PFOs, as well as the prevalence of stroke due to other etiologies. When treating this disease, the physician must be able to weigh the likelihood of benefit versus the risk of the procedure, as well as patient preference.

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“…Although transcatheter closure of the PFO has been available for more than two decades, the use of this procedure has remained controversial due to a paucity of evidence to guide patient eligibility and device selection14. Recent contemporary studies have investigated PFO closure as treatment for patients with cryptogenic stroke, migraine, and orthodeoxia/platypnea, such that longitudinal data regarding the safety and efficacy of these devices is now available58151617181920. However, no study to date has investigated PFO closure for the treatment of migraine in the Chinese population.…”

mentioning

confidence: 99%

Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine (EASTFORM) Trial

Xing¹,

Guo²,

Gao³

et al. 2016

Sci Rep

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We evaluated the safety and effectiveness of transcatheter patent foramen ovale (PFO) closure for the treatment of migraine in a Chinese population. This non-randomized clinical trial enrolled 258 consecutive substantial or severe migraineurs with a right-to-left shunt (RLS) (grade II–IV) and grouped subjects according to their election or refusal of PFO closure. Migraine was diagnosed according to the International Classification of Headache Disorders III-beta and evaluated using the Headache Impact Test-6 (HIT-6). In total, 241 participants (125 in the transcatheter closure group and 116 in the control group) were included in the study. In general, the PFO closure procedure was found to be safe. At 1 month after closure, 76.1% of patients returned for c-TCD evaluation; of these, 85.7% were downgraded to negative status or a grade-I shunt. Residual shunts and placebo effects were thought to resolve by 12 months post-procedure, when migraine impact was reported to decrease by 73.6%. Transcatheter PFO closure was demonstrated to be effective for the treatment of migraine by comparing HIT-6 scores between the transcatheter closure and control groups (p < 0.001). Our results suggest that transcatheter PFO closure is a safe and effective approach for the treatment of migraine in the Chinese population, especially in females with constant RLS. Clinical trial no. NCT02127294 (registered on April 29, 2014).

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Comparison of residual shunt rates in five devices used to treat patent foramen ovale

Abstract: Transcatheter PFO closure has a high success rate, but a moderate residual shunt occurs in about 10% of cases. The observed incidence of residual shunting after PFO closure is significantly larger with the 30-mm Helex device. © 2014 Wiley Periodicals, Inc.

Cited by 30 publications

References 25 publications

Comparison of residual shunt rate and complications across 6 different closure devices for patent foramen ovale

Comparison of residual shunt rate and complications across 6 different closure devices for patent foramen ovale

Role of Occlusive Devices to Prevent Thromboembolism Among Persons With a Patent Foramen Ovale and Prior Stroke

Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine (EASTFORM) Trial

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