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Andreas Wahl*, Fabien Praz*, Bindu Kalesan † , Marie-Luise Mono # , Laura Geister # , Krassen Nedeltchev # , Lorenz Räber*, PowerPoint PPT Presentation


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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 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 Räber*,

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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* andNeurology#and Clinical Trials Unit†

Bern University Hospital, Switzerland


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Conflicts of Interest

  • Research grants

  • Lectureandconsultationfees

    • AGA Medical, Plymouth, MN, USA


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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


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Silent Cerebral Infarctions (by MR)

2,040 Framingham Offsprings

(53% female; mean age, 62±9 years)

Das RR, Stroke. 2008;39:2929-2935


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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


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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


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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


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    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


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    Patient Characteristics Before Propensity Score Matching (N=308)


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    Patient Characteristics After Propensity Score Matching (N=206)


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    Patient Characteristics Before Propensity Score Matching (N=308)


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    Patient Characteristics After Propensity Score Matching (N=206)


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    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%


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    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%


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    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%


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    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%


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    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


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    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%


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    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%


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    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%


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    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


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    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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