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Andreas Wahl*, Fabien Praz*, Bindu Kalesan † , Marie-Luise Mono # , Laura Geister # , Krassen Nedeltchev # , Lorenz Räb

Long-Term Comparison of Medical 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 # ,

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Andreas Wahl*, Fabien Praz*, Bindu Kalesan † , Marie-Luise Mono # , Laura Geister # , Krassen Nedeltchev # , Lorenz Räb

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  1. 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* andNeurology#and Clinical Trials Unit† Bern University Hospital, Switzerland

  2. Conflicts of Interest • Research grants • Lectureandconsultationfees • AGA Medical, Plymouth, MN, USA

  3. PFO as Predictor of Adverse Outcome in 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

  4. Silent Cerebral Infarctions (by MR) 2,040 Framingham Offsprings (53% female; mean age, 62±9 years) Das RR, Stroke. 2008;39:2929-2935

  5. Prevalence of PFO According to Age PFO in 263/965 autopsies (mean 27%) Y=35-0.12x R2=0.6, p=0.008 Selective mortality? % Age (years) Hagen PT, Mayo Clin Proc 1984; 59: 17-20

  6. 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

  7. Patient Population • Inclusion Criteria • All 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 ± atrialseptal aneurysm (contrast TEE) • Exclusion Criteria • Obvious other cardiac, aortic, or cerebrovascular cause • Treatment decision • Based on consensus among neurologist and patient

  8. Patient Flow – Intention toTreat Analysis (Windecker S, JACC 44: 750-8, 2004) 308 Patients Jan. 1994 – Aug. 2000 Percutaneous PFO closure 150 patients Medical treatmentalone 158 patients • 6 brandsused • 42% Amplatzeroccluders • 6% acutecomplications (nosequelae), nolatecomplications • 87% completeclosure, 4% after 2nd intervention • 50% antiplatelettherapy • 50% warfarin After Propensity Score Matching 206 Patients Percutaneous PFO closure 103 Patients Medical treatmentalone 103 Patients • 27% PFO closure during follow-up Clinical Follow-up Median 10.3 years 1,011 patient-years 1,170 patient-years All neurovasculareventsadjudicatedbyneurologist

  9. Patient Characteristics Before Propensity Score Matching (N=308)

  10. Patient Characteristics After Propensity Score Matching (N=206)

  11. Patient Characteristics Before Propensity Score Matching (N=308)

  12. Patient Characteristics After Propensity Score Matching (N=206)

  13. Primary Endpoint – Propensity Score MatchedCohort Stroke, TIA, orPeripheralEmbolismat 10 Years Medical Treatment 21.4% HazardRatio = 0.43 95% CI 0.20 – 0.94 P=0.033 PFO Closure 10.7%

  14. Propensity Score MatchedCohort All CauseMortalityat 10 Years Hazard Ratio = 1.00, 95% CI 0.32 – 3.10 P=1.00 Medical Treatment 5.8% PFO Closure 5.8%

  15. Propensity Score MatchedCohort IschemicStrokeat 10 Years Hazard Ratio = 0.75, 95% CI 0.26 – 2.16, P=0.59 Medical Treatment 7.8% PFO Closure 5.8%

  16. Propensity Score MatchedCohort Transient IschemicAttackat10Years Medical Treatment 13.6% Hazard Ratio = 0.31 95% CI 0.10 – 0.94 P=0.039 PFO Closure 4.9%

  17. Propensity-Matched Cohort Stroke/TIA/Periph. Embol. HR (95% CI) P Overall 0.43 (0.20-0.94) 0.033 PFO only 0.42 (0.15-1.18) 0.54 PFO and ASA 0.61 (0.20-1.86) Age <55 yrs 0.33 (0.09-1.23) 0.69 Age ≥55 yrs 0.50 (0.09-2.73) Female 0.14 (0.03-0.76) 0.07 Male 1.00 (0.29-3.45) Nosevereshunt 0.25 (0.03-2.24) 0.21 Severeshunt 0.70 (0.27-1.84) ≤1 event 1.00 (0.35-2.85) 0.074 >1 event 0.22 (0.06-0.80) Index event TIA 0.04 (0.00-0.63) 0.039 Index eventstroke 0.86 (0.29-2.55) PFO closurebetter Medical tr. better

  18. Primary Endpoint – Intention toTreat Population IschemicStroke, TIA, orPeripheralEmbolismat 10 Years Medical Treatment 21.5% HazardRatio = 0.40 95% CI 0.22 – 0.75 P=0.004 PFO Closure 9.3%

  19. Intention toTreat Population (N=308) All CauseMortalityat 10 Years Hazard Ratio = 0.55, 95% CI 0.22 - 1.38, P=0.21 Medical Treatment 8.2% PFO Closure 4.7%

  20. Intention toTreat Population (N=308) TIA at10Years Medical Treatment 11.4% Hazard Ratio = 0.40 95% CI 0.17 – 0.96 P=0.04 PFO Closure 4.7%

  21. Event Rates per Year (%) Device No Device P<0.001 (1,796 patient-years) (1,323 patient-years) P<0.001 P<0.001 P<0.001 NS

  22. Conclusions • PFO closure appears more effective than medical treatment for secondary prevention of recurrent cerebrovascular events among patients with stroke or TIA presumably related to PFO. • Less death, stroke, or TIA with a PFO closure device than without. • Results require confirmation in randomized clinical trials.

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