Transcatheter closure of patent foramen ovale for secondary prevention of ischemic stroke: Quantitative synthesis of pooled randomized trial data

Hakeem, Abdul; Çilingiroğlu, Mehmet; Katramados, Angelos; Boudoulas, Konstantinos Dean; Iliescu, Cezar; Gündoğdu, Betül; Marmagkiolis, Konstantinos

doi:10.1002/ccd.27487

Cited by 11 publications

(7 citation statements)

References 29 publications

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“…These findings are in line with the results of recent meta-analyses. 20 –28 However, in our pooled analysis, we also included the results of the recently published randomized trial (device closure versus medical therapy for cryptogenic stroke patients with high-risk patent foramen ovale [DEFENSE-PFO]), 19 and we identified the high-risk patients who could best benefit from the PFO closure, performing cumulative subgroup analyses (ie, age, gender, shunt level, entry event,…), not all included in previous analyses. This pooled analysis showed a 59% significant risk reduction in recurrent stroke in the interventional group compared to the medical treatment only group and a 42% risk reduction when TIA was combined as qualifying event.…”

Section: Discussionmentioning

confidence: 99%

Patent Foramen Ovale Closure Versus Medical Therapy in Cryptogenic Strokes and Transient Ischemic Attacks: A Meta-Analysis of Randomized Trials

Vidale

Russo²,

Campana³

et al. 2018

Angiology

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Cryptogenic strokes account for about 25% to 40% of total ischemic strokes, and 1 of the 3 of these have a patent foramen ovale (PFO). A meta-analysis concerning the effectiveness and safety of PFO closure in cryptogenic strokes or transient ischemic attacks (TIAs) was performed. We systematically searched Medline, Embase, and the Cochrane Library through April 2018. Eligible studies were randomized clinical trials. Primary and secondary end points were, respectively, stroke or TIA and stroke recurrences. We calculated risk ratios (RRs) and 95% confidence intervals (CIs) for all end points using fixed- and random-effects meta-analyses. Data were included from 6 trials involving 3560 patients. In the pooled analysis, PFO closure was superior to medical treatment for both primary (RR: 0.39; 95% CI: 0.18-0.82; P < .02) and secondary end points (RR: 0.58; 95% CI: 0.44-0.76; P < .001). Transcatheter closure significantly increased the risk of new-onset atrial fibrillation (AF; RR: 5.74; P < .001). Percutaneous closure is superior to medical treatment in reducing stroke and TIA recurrence, even if with a significant risk increasing for new-onset AF. These findings suggest that transcatheter closure is indicated in patients with cryptogenic strokes and large PFO.

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Section: Discussionmentioning

confidence: 99%

Patent Foramen Ovale Closure Versus Medical Therapy in Cryptogenic Strokes and Transient Ischemic Attacks: A Meta-Analysis of Randomized Trials

Vidale

Russo²,

Campana³

et al. 2018

Angiology

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“…In the largest study of PFO size and relation to ischemic stroke, PFO size was not a significant predictor of the index event (16). Secondary features of PFO such as the presence of a Eustachian valve, Chiari network or a long PFO tunnel were suggested to be linked to PFO-associated strokes in some retrospective studies (17,18) but not others (19)(20)(21). A case of PFO-associated stroke is presented in Figure 1 and Supplementary Videos 1, 2.…”

Section: Introductionmentioning

confidence: 98%

A Narrative and Critical Review of Randomized-Controlled Clinical Trials on Patent Foramen Ovale Closure for Reducing the Risk of Stroke Recurrence

et al. 2020

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Patent foramen ovale (PFO) is a common cardiac anatomic variant that has been increasingly found in young (<60 years) cryptogenic stroke patients. Despite initial neutral randomized-controlled clinical trials (RCTs), there have been four recent RCTs providing consistent data in favor of the efficacy and safety of PFO closure compared to medical therapy for secondary stroke prevention. However, taking into consideration the high prevalence of PFO, the low risk of stroke recurrence under medical treatment and the uncommon yet severe adverse events of the intervention, patient selection is crucial for attaining meaningful clinical benefits. Thorough workup to exclude alternative causes of stroke and identification of high-risk PFOs through clinical, neuroimaging and echocardiographic criteria are essential. Cost effectiveness of the procedure cannot be proven for the time being, since there are no robust data on clinical outcome after PFO-associated stroke but only limited anecdotal data suggesting low risk for long-term disability.

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“…In the setting of PFO closure, primary procedural success rates of about 100% have been reported, 29,34 and complete closure has been demonstrated in 93–96% at 1 year 35 . Notably, a higher risk of residual shunts has been observed if larger devices have been used 4 .…”

Section: Prognosis After Patent Foramen Ovale Closure and Gaps In The...mentioning

confidence: 99%

Patent foramen ovale closure after cryptogenic stroke: sometimes uncertain benefit maybe, or even potential harm in the long run?

Dell'Angela

Nicolosi²

2023

Journal of Cardiovascular Medicine

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The main published studies on patent foramen ovale (PFO) closure after cryptogenic stroke tend to consider it positively, in light of the reported both procedural risk profile and outcomes. On the other hand, many blind spots and controversial issues of the topic are still present, mainly including both early procedural complications, and mid-and long-term associated comorbidities as well. Oftentimes, several biases appear to be present, with the evident risk of modifying indications for both intervention, and decision-making process. Biases should be considered and discussed during the diagnostic approach as well, including the supposed evidence of correlation, or cause-effect relationship, between the clinical event and patent foramen ovale. Furthermore, such studies have mostly shown results based on short-term follow-up and very low event rates. Conversely, those patients will keep the device lifelong, generally with long life expectancy, and the increased possibility of recurrent stroke from any other cause over time, along with many potential device-related comorbidities (e.g. atrial fibrillation, nearby anatomical structures impairment, and thrombosis). Consequently, it is hard to demonstrate the mid-term and long-term device-related advantages, due to the possible higher incidence of stroke associated with iatrogenic or concurrent factors. Thus, larger, well designed, long-term, multicentric, and more inclusive studies are needed, aimed to demonstrate a net clinical benefit, ideally including a number-needed-totreat calculation at short-term, mid-term, and long-term, as well as taking into account and comparing the long-term complications, related outcomes, and recurrent events in patients with and without devices.

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Transcatheter closure of patent foramen ovale for secondary prevention of ischemic stroke: Quantitative synthesis of pooled randomized trial data

Abstract: Based on the results of this analysis of randomized trial data, percutaneous PFO closure appears to be a safe and effective therapeutic option for the secondary prevention of ischemic stroke in patients with PFO and cryptogenic stroke.

Cited by 11 publications

References 29 publications

Patent Foramen Ovale Closure Versus Medical Therapy in Cryptogenic Strokes and Transient Ischemic Attacks: A Meta-Analysis of Randomized Trials

Patent Foramen Ovale Closure Versus Medical Therapy in Cryptogenic Strokes and Transient Ischemic Attacks: A Meta-Analysis of Randomized Trials

A Narrative and Critical Review of Randomized-Controlled Clinical Trials on Patent Foramen Ovale Closure for Reducing the Risk of Stroke Recurrence

Patent foramen ovale closure after cryptogenic stroke: sometimes uncertain benefit maybe, or even potential harm in the long run?

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