Implantable devices for the closure of patent foramen ovale in adults: an Italian rapid health technology assessment

Abstract

Percutaneous closure of patent foramen ovale (PFO) is offered to patients suffering from cryptogenic stroke, transient ischemic attack or persistent migraine. Several PFO closure devices are CE marked but none have yet been approved by the FDA. On the Italian market 11 different PFO closure devices are available and more than 2500 PFO procedures were reported in 2012. We report findings of a systematic review and meta-analysis of studies in which patients with PFO and transient ischemic attacks, cryptogenic stroke or persistent migraine who underwent PFO closure were compared to patients treated by usual care. We included five controlled clinical trials and one randomized controlled trial. Included studies had poor methodological quality and heterogeneity. In the included randomized controlled trial, 4.7% of procedure-related serious adverse events were observed. Large multicenter, sufficiently powered, and properly randomized trials need to be conducted in Europe with particular attention to patient selection.

Keywords::

• cardiac occlude
• health technology assessment
• medical device regulation
• patent foramen ovale
• PFO occlude
• rapid HTA

Financial & competing interests disclosure

The present paper comes from the first Italian experience of rapid HTA report on medical devices. The original project was funded by the Italian Ministry of Health and developed with the collaboration of experts from the Italian regions joined in the RIHTA network. Four of the authors of the present paper (excluding MC) were authors of the report cited as [4].

The authors have no affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript.

No writing assistance was used in the production of this manuscript.

Key issues

• Patent foramen ovale (PFO) is a condition present in 25% of the adult population and, if not symptomatic, does not require any treatment.

• Some studies hypothesized associations between PFO and cryptogenic stroke, transient ischemic attach or persistent migraine.

• Percutaneous PFO occlusion by implantable device (PFO occluders) has been proposed to patients with PFO with the aim to reduce cryptogenic stroke, transient ischemic attach or migraine recurrence.

• Evidence of superiority of percutaneous PFO closure over the standard medical management has not been demonstrated to date and the trials recently closed showed no real benefits of such treatment.

• Eleven PFO occluders are approved for clinical use in Europe; none of them have yet received US FDA approval.

• Recent scandals highlighted several deficiencies in the current regulatory system for authorization of medical devices in Europe.

• Even if Conformité Européenne marked in full accordance with the law, high-risk medical devices available on the European market may not be properly tested in the premarket phase in term of clinical effectiveness and safety.

• Decision-makers should promote the use of those devices for which an evidence base has been made available and design evidence-generating frameworks and strategy for the use of the newest technologies for which evidence is still lacking.