Patent foramen ovale (PFO) has been associated with cryptogenic stroke and transient ischemic attack (TIA) in young adults. Evidence from randomized clinical trials (RCT) has shown that transcatheter PFO closure yields a 59% relative reduction in recurrent ischemic stroke compared to medical therapy in selected individuals. However, the follow-up duration in these studies averaged around 4 years, while only two studies report a median follow-up beyond 10 years. Considering the relative youth of the patients undergoing this procedure (average age being under 50 years across all studies), we can reasonably anticipate a substantial post-PFO closure lifespan for these individuals. Consequently, it is imperative to gather more extensive long-term follow-up data among PFO closure recipients The PROLONG (PFO tRanscatether Occlusion Long-term Outcomes National Group) is an observational, retrospective, multicenter, national registry including men and women undergoing transcatheter PFO closure, with the aim of assessing the long-term (\>10 years) efficacy and safety of this procedure.
The PROLONG (PFO Transcatheter Occlusion Long-term Outcomes National Group) is an observational, retrospective, multicenter registry. It includes 1,360 subjects who underwent transcatheter patent foramen ovale (PFO) closure between 1999 and 2013 at 12 Italian high-volume Centers. Patients will have at least 10 years of follow-up post-procedure. The primary objectives of the study are to evaluate the long-term clinical effectiveness of PFO closure by the incidence of left-sided embolic events and to evaluate safety by assessing serious device- or procedure-related adverse events. Secondary objectives include the incidence of new-onset atrial arrhythmias, the presence and severity of residual shunts, the incidence and severity of migraine symptoms, and bleeding events.
Study Type
OBSERVATIONAL
Enrollment
1,360
Transcatheter PFO closure with any commercially available septal occluder device
Number of Participants with ischemic stroke, transient ischemic attack or systemic embolism (SE) post device implant (Primary Effectiveness Outcome)
The primary effectiveness outcome is the composite incidence of stroke, transient ischemic attack (TIA), and systemic embolism (SE) post-PFO closure.
Time frame: Duration of follow-up (minimum of 10 years)
Number of Participants with device- or procedure-related serious adverse events (Primary Safety Endpoint)
Device- or procedure- related serious adverse events post device implant
Time frame: Duration of follow-up (minimum of 10 years)
Number of Participants with recurrent ischemic stroke
Incidence of ischemic stroke post-PFO closure.
Time frame: Time Frame: Duration of follow-up (minimum of 10 years)
Number of Participants withrecurrent transient ischemic attack (TIA)
Incidence of transient ischemic attack (TIA) post-PFO closure.
Time frame: Time Frame: Duration of follow-up (minimum of 10 years)
Number of Participants with with recurrent systemic embolism (SE)
Incidence of systemic embolism (SE) post-PFO closure.
Time frame: Time Frame: Duration of follow-up (minimum of 10 years)
Rate of Procedural Success
The rate of successful PFO closure as determined by the absence of severe residual shunt or any procedure- or device-related serious adverse event (SAE)
Time frame: Time Frame: Duration of follow-up (minimum of 10 years)
Incidence of Clinically Significant New Atrial Arrhythmia
The occurrence of new-onset atrial fibrillation (AF) or atrial flutter (AFL) following PFO-closure
Time frame: Time Frame: Duration of follow-up (minimum of 10 years)
Rate of All-cause mortality
The overall mortality rate of patients post-PFO closure, including both cardiac and non-cardiac causes, documented during follow-up.
Time frame: Time Frame: Duration of follow-up (minimum of 10 years)
Rate of residual shunt
Characterization of presence and severity of a residual shunt post-PFO closure, as detected by follow-up echocardiographic assessments.
Time frame: Time Frame: Duration of follow-up (minimum of 10 years)
Incidence of Device-Related and procedure-related Complications
The rate of complications related to the PFO closure device, such as device embolization, erosion, or thrombosis, documented during follow-up.
Time frame: Time Frame: Duration of follow-up (minimum of 10 years)
Incidence of bleeding events
The rate of bleeding events according to the Bleeding Academic Research Consortium (BARC) criteria
Time frame: Time Frame: Duration of follow-up (minimum of 10 years)
Incidence of migraine symptoms
The presence and severity of migraine symptoms will be documented
Time frame: Time Frame: Duration of follow-up (minimum of 10 years)
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