Network meta-analysis on patent foramen ovale: is a stroke or atrial fibrillation worse?
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REVIEW ARTICLE
Network meta-analysis on patent foramen ovale: is a stroke or atrial fibrillation worse? Leonardo Varotto 1 Francesco Perini 3
&
Gianni Bregolin 2 & Mariemma Paccanaro 1 & Antonella De Boni 3 & Carlo Bonanno 1 &
Received: 21 September 2020 / Accepted: 18 November 2020 # The Author(s) 2020
Abstract 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 randomeffects) 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. Keywords Cryptogenic . PFO or patent foramen ovale . Ischemic stroke or cerebrovascular accident . Transient ischemic attack or TIA . Paradoxical embolism
Introduction Ischemic stroke is one of the leading causes of death and disability worldwide. Fundamental to the management of stroke patients is the prevention of further ischemic events.
* Leonardo Varotto [email protected] 1
Department of Cardiology, San Bortolo Hospital, viale Rodolfi 37, 36100 Vicenza, Italy
2
Department of Prevention, AULSS 8 Berica, via IV Novembre 46, 36100 Vicenza, Italy
3
Department of Neurology, San Bortolo Hospital, viale Rodolfi 37, 36100 Vicenza, Italy
This rule applies especially to patent foramen ovale (PFO)– related stroke in young patients. Many meta-analyses suggest that PFO closure can be performed percutaneously with generally low complication rates, but have shown that PFO closure increases the risk of atrial fibrillation (AF) [1–5]. Most cases of AF in the randomized controlled trials (RCTs) occurred early after implantation and consisted of a single paroxysmal epi
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