Atrial Fibrillation New Onset, Patent Foramen Ovale, Stroke, Cryptogenic, Transient Ischaemic Attack Due to Embolism
Conditions
Keywords
Patent Foramen Ovale, Stroke, Cryptogenic, Stroke, Transient Ischemic Attack, Atrial Fibrillation, Interventional cardiology
Brief summary
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.
Detailed description
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.
Interventions
DEVICESeptal Occluder Device
Transcatheter PFO closure with any commercially available septal occluder device
Sponsors
Centro Cardiologico Monzino
University Hospital Padova
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Azienda Policlinico Umberto I
Azienda Ospedaliero Universitaria Maggiore della Carita
IRCCS Azienda Ospedaliero-Universitaria di Bologna
San Camillo Hospital, Rome
Clinica San Martino
University Of Perugia
Maria Cecilia Hospital
IRCCS Ospedale San Raffaele
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years; * Confirmed Patent Foramen Ovale (PFO); * Transcatheter Patent Foramen Ovale (PFO) closure with an Occluder device; * PFO closure procedure performed between 1999 and 2013.
Exclusion criteria
* Age \< 18 years; * Previous surgical or transcatheter PFO closure; * Patients without follow-up data available.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with ischemic stroke, transient ischemic attack or systemic embolism (SE) post device implant (Primary Effectiveness Outcome) | Duration of follow-up (minimum of 10 years) | The primary effectiveness outcome is the composite incidence of stroke, transient ischemic attack (TIA), and systemic embolism (SE) post-PFO closure. |
| Number of Participants with device- or procedure-related serious adverse events (Primary Safety Endpoint) | Duration of follow-up (minimum of 10 years) | Device- or procedure- related serious adverse events post device implant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with with recurrent systemic embolism (SE) | Time Frame: Duration of follow-up (minimum of 10 years) | Incidence of systemic embolism (SE) post-PFO closure. |
| Rate of Procedural Success | Time Frame: Duration of follow-up (minimum of 10 years) | 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) |
| Incidence of Clinically Significant New Atrial Arrhythmia | Time Frame: Duration of follow-up (minimum of 10 years) | The occurrence of new-onset atrial fibrillation (AF) or atrial flutter (AFL) following PFO-closure |
| Rate of All-cause mortality | Time Frame: Duration of follow-up (minimum of 10 years) | The overall mortality rate of patients post-PFO closure, including both cardiac and non-cardiac causes, documented during follow-up. |
| Number of Participants with recurrent ischemic stroke | Time Frame: Duration of follow-up (minimum of 10 years) | Incidence of ischemic stroke post-PFO closure. |
| Incidence of Device-Related and procedure-related Complications | Time Frame: Duration of follow-up (minimum of 10 years) | The rate of complications related to the PFO closure device, such as device embolization, erosion, or thrombosis, documented during follow-up. |
| Incidence of bleeding events | Time Frame: Duration of follow-up (minimum of 10 years) | The rate of bleeding events according to the Bleeding Academic Research Consortium (BARC) criteria |
| Incidence of migraine symptoms | Time Frame: Duration of follow-up (minimum of 10 years) | The presence and severity of migraine symptoms will be documented |
| Rate of residual shunt | Time Frame: Duration of follow-up (minimum of 10 years) | Characterization of presence and severity of a residual shunt post-PFO closure, as detected by follow-up echocardiographic assessments. |
| Number of Participants withrecurrent transient ischemic attack (TIA) | Time Frame: Duration of follow-up (minimum of 10 years) | Incidence of transient ischemic attack (TIA) post-PFO closure. |
Outcome results
None listed