Amplatzer patent foramen ovale occluder: safety and efficacy

Madhkour, Raouf; Wahl, Andreas; Praz, Fabien; Meier, Bernhard

doi:10.1080/17434440.2019.1581060

Cited by 20 publications

(15 citation statements)

References 55 publications

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“…Many observations have also stated that the new-onset of AF after PFO closure depends on the type of device used and that the Amplatzer device seems to appear better in preventing episodes of AF, when compared to other devices [8][9][10][11].…”

Section: Introductionmentioning

confidence: 99%

Network meta-analysis on patent foramen ovale: is a stroke or atrial fibrillation worse?

Varotto

Bregolin²,

Paccanaro

et al. 2020

Neurol Sci

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Objective Systematic reviews suggest that patent foramen ovale closure (PFOc) is performed percutaneously with low complication rates. We did a network meta-analysis (NMA) comparing devices for PFO closures, evaluating safety and efficacy of transcatheter PFOc in preventing neurological events in patients with stroke when compared with medical therapy (MT), and assessing risk of atrial fibrillation (AF). Methods We searched 3 databases (MEDLINE, EMBASE, CENTRAL/CCTR) identifying six randomized controlled trials from 2012 until December 2019. We performed a Bayesian NMA; number-needed-to-treat and number-needed-to-harm were derived by applying the estimated odds ratios (ORs). The likelihood of being helped or harmed (LHH) was evaluated to estimate the risk-effectiveness balance. Results The 3560 patients allocated to PFOc were less subject to a stroke than patients with MT. The overall ORs of PFOc versus MT were 0.41 with fixed-effects, and 0.22 with random-effects model. NMA proves that PFOc induces AF episodes significantly higher than MT, even when analysis is limited to only new episodes of “serious AF.” LHH (0.68 fixed-effects, 0.79 random-effects) showed that strokes saved are less than cases of AFs added. By considering only serious AF, strokes saved are higher than serious AFs induced by the PFOc (LHH was 3.46 and 4.00 respectively). Conclusions NMA supported PFOc in patients with cryptogenic stroke, confirming that devices are better than MT, but increase the risk of AF by over 2/4 times (serious or unserious AF). Considering serious AFs (real risky clinical condition), patients have more advantages in being treated, since LHH is ≥ 3–4.

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Section: Introductionmentioning

confidence: 99%

Network meta-analysis on patent foramen ovale: is a stroke or atrial fibrillation worse?

Varotto

Bregolin²,

Paccanaro

et al. 2020

Neurol Sci

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“…This allows free movement of both disks, permitting a flexible adaption of the disk to the septum. 3 This device was utilized in our case with excellent result. Upon closure of the PFO, the hypoxemia resolved with an improvement in the SaO2 to 91%.…”

Section: Discussionmentioning

confidence: 72%

“…Recently, the Food and Drug Administration has approved the use of Amplatzer PFO Occluder (AGA Medical Corp., Golden Valley, MN, USA) created by Abbot. 3 The Amplatzer is a self-expanding double disk device that is connected by a narrow flexible waist. This allows free movement of both disks, permitting a flexible adaption of the disk to the septum.…”

Section: Discussionmentioning

confidence: 99%

Percutaneous Closure of Patent Foramen Ovale in the Setting of Pulmonary Embolism (Right-Left Shunt Causing Severe Hypoxia)

Johnson

Kodra

Basman

et al. 2020

Innovations�(Phila)

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A patent foramen ovale (PFO) is well known to cause paradoxical embolism and stroke, but a less appreciated and life-threatening complication can occur when combined with severe pulmonary embolism (PE). Acutely elevated right-sided pressures from right ventricular strain due to PE can lead to right-to-left (R-L) shunting through the PFO and exacerbate hypoxia. We report a case of a 50-year-old female patient with massive PE with further desaturation from R-L shunting from a PFO that benefitted from percutaneous closure of the interartrial communication. Our patient recovered without any complications and had excellent long-term follow-up.

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“…Many observations and studies have also stated that the effectiveness of PFO closure depends on the type of device used and that the Amplatzer (AMP) device appear to be better than others in preventing strokes and episodes of atrial fibrillation (AF) [11][12][13][14]. In the past, a NMA has been performed [15], demonstrating the superiority of a marketleading PFO occluder, but with "low quality evidence" [16].…”

Section: Introductionmentioning

confidence: 99%

The Closure of Patent Foramen Ovale in Preventing Subsequent Neurological Events: A Bayesian Network Meta-Analysis to Identify the Best Device

Varotto

Bregolin²,

Paccanaro

et al. 2020

Cerebrovasc Dis

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Background: Randomized-controlled trials (RCTs) reported a finding on the safety and efficacy of percutaneous patent foramen ovale (PFO) closure to prevent stroke recurrence. It showed that the Amplatzer (AMP) device appears to be superior to medical therapy (MT) in preventing strokes and episodes of atrial fibrillation (AF), than other devices. We performed a network meta-analysis (NMA) to evaluate the closure of PFO in preventing subsequent neurological events while investigating the results obtained by specific devices. Methods: We searched 3 databases (MEDLINE, EMBASE, CENTRAL/CCTR) and identified 6 RCTs until March 2019. We performed an NMA and used pooled ORs. Analyses were done in NetMetaXL1.6-WinBUGS1.4. Results: Six RCTs with 3,560 patients (mean age 45.2-46.2 years) were included in the present NMA. Depending on the device, 4 groups of pa-tients were compared with MT: 1,889 patients undergoing PFO closure were significantly less likely to experience a stroke than 1,671 patients treated with MT (ORs 0.41; 95% Cr.I. 0.27-0.60 with fixed-effects model and ORs 0.22; 95% Cr.I. 0.05-0.70 with random-effects model). The patients with AMP showed a similar risk than those treated with Helex/Cardioform (HLX/CF) or with a group of 11 multiple devices. This suggests the equality between the 2 most currently used devices. When assessing TIA and, for the safety analysis, major bleeding, both models confirm no significant difference between any devices and MT. PFO closure increased the risk of new-onset AF: MT induces AF significantly less than all the devices. In favor of the AMP, there is a reduced number of cases of AF versus MT; however, no device superiority has been established in comparing HLX/CF and other devices in a random effect model. Conclusions: Our NMA provides evidence in favor of PFO closure with all the devices currently in use. We can conclude that these devices are better than MT, but not that 1 device is better than the rest in reducing stroke recurrences and AF episodes in the follow-up.

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Amplatzer patent foramen ovale occluder: safety and efficacy

Cited by 20 publications

References 55 publications

Network meta-analysis on patent foramen ovale: is a stroke or atrial fibrillation worse?

Network meta-analysis on patent foramen ovale: is a stroke or atrial fibrillation worse?

Percutaneous Closure of Patent Foramen Ovale in the Setting of Pulmonary Embolism (Right-Left Shunt Causing Severe Hypoxia)

The Closure of Patent Foramen Ovale in Preventing Subsequent Neurological Events: A Bayesian Network Meta-Analysis to Identify the Best Device

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