Treatment With Percutaneous Closure of Patent Foramen Ovale for Secondary Prevention of Paradoxical Embolism: A Propensity-Score Matched Comparison Andreas Wahl*, Fabien Praz*, Bindu Kalesan † , Marie-Luise Mono # , Laura Geister # , Krassen Nedeltchev # , Lorenz Räber*, Heinrich P. Mattle # , Peter Jüni † , Stephan Windecker*, Bernhard Meier* Departments of Cardiology* and Neurology # and Clinical Trials Unit † Bern University Hospital, Switzerland
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Long-Term Comparison of Medical Treatment With Percutaneous Closure of Patent Foramen Ovale for Secondary Prevention of Paradoxical Embolism: A Propensity-Score.
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Long-Term Comparison of Medical Treatment With Percutaneous Closure of Patent Foramen Ovale for SecondaryPrevention of Paradoxical Embolism:
A Propensity-Score Matched Comparison
Andreas Wahl*, Fabien Praz*, Bindu Kalesan†, Marie-Luise Mono#,
Laura Geister#, Krassen Nedeltchev#, Lorenz Räber*,
Heinrich P. Mattle#, Peter Jüni†, Stephan Windecker*, Bernhard Meier*
Departments of Cardiology* and Neurology# and Clinical Trials Unit†
Bern University Hospital, Switzerland
Conflicts of Interest
• Research grants• Lecture and consultation fees
– AGA Medical, Plymouth, MN, USA
PFO as Predictor of Adverse Outcomein Patients With Major Pulmonary Embolism
Konstantinides S et al. Circulation 1998;97:1946
- PFO: independent predictor of mortality- Suggested mechanism: paradoxical
embolism
• 139 patients with major pulmonary embolism undergoing TEE • 35% with PFO • 59 ± 17 (17 - 89) years
• Clinical endpoints • death • cerebral embolism • arterial thrombo-embolism • major bleeding
Percutaneous PFO Closure• Percutaneous PFO closure has been shown to be
safe and efficacious using several devices- Small procedural risk
- Minimal long-term risk
- Satisfactory closure rate
- Acceptable cost (outpatient procedure)
• Observational, non-randomized data suggest a lower risk of recurrence as compared to medical treatment alone
• No randomized trial published to date
• Limitations of ongoing randomized trials- High risk patients closed with device, not randomized
- Follow-up too short
Patient Population
Inclusion CriteriaAll patients with ischemic stroke or TIA, confirmed clinically or radiologically at the University Hospital of Bern Stroke Center between January 1994 and August 2000 were prospectively entered into the stroke/PFO registry if they had
- PFO ± atrial septal aneurysm (contrast TEE)
Exclusion CriteriaObvious other cardiac, aortic, or cerebrovascular cause
Treatment decisionBased on consensus among neurologist and patient
Patient Flow – Intention to Treat Analysis308 Patients
Jan. 1994 – Aug. 2000
Medical treatment alone158 patients
Percutaneous PFO closure150 patients
Medical treatment alone103 Patients
Percutaneous PFO closure103 Patients
Clinical Follow-upMedian 10.3 years
1,170 patient-years1,011 patient-years
After Propensity Score Matching 206 Patients
- 6 brands used- 42% Amplatzer occluders- 6% acute complications (no sequelae), no late
complications- 87% complete closure, 4% after 2nd intervention
- 50% antiplatelet therapy - 50% warfarin
- 27% PFO closure during follow-up
All neurovascular events adjudicated by neurologist
(Windecker S, JACC 44: 750-8, 2004)
PFO Closure150 Patients
Medical Treatment158 Patients
P
Age 50±12 51±13 0.55
Male , % 54 58 0.39
Diabetes mellitus, % 4 9 0.08
Hypertension, % 28 32 0.49
Hypercholesterolemia, % 45 29 0.003
Smoking, % 33 32 0.94
Cerebrovascular index event, % 0.022
- Ischemic stroke 65 77
- TIA 35 23
Mean number of CV events 1.8±1.1 1.5±1.0 0.025
More than 1 CV event, % 39 28 0.033
Patient Characteristics Before Propensity Score Matching (N=308)
PFO Closure103 Patients
Medical Treatment103 Patients
P
Age 49±12 50±13 0.65
Male , % 52 55 0.68
Diabetes mellitus, % 5 3 0.47
Hypertension, % 26 30 0.54
Hypercholesterolemia, % 29 35 0.37
Smoking, % 30 31 0.88
Cerebrovascular index event, % 0.44
- Ischemic stroke 75 70
- TIA 25 30
Mean number of CV events 1.5±1.0 1.5±0.9 0.88
More than 1 CV event, % 25 28 0.64
Patient Characteristics After Propensity Score Matching (N=206)
PFO Closure150 Patients
Medical Treatment158 Patients
P
Atrial septal anatomy, % 0.6
- PFO only 75 78
- PFO and atrial septal aneurysm 25 22
Interatrial shunt grade, % 0.001
- Small 3 11
- Moderate 17 28
- Large 79 61
Patient Characteristics Before Propensity Score Matching (N=308)
PFO Closure103 Patients
Medical Treatment103 Patients
P
Atrial septal anatomy, % 0.41
- PFO only 74 79
- PFO and atrial septal aneurysm 26 21
Interatrial shunt grade, % 0.40
- Small 4 9
- Moderate 11 21
- Large 74 70
Patient Characteristics After Propensity Score Matching (N=206)