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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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slide1

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

conflicts of interest
Conflicts of Interest
  • Research grants
  • Lectureandconsultationfees
    • AGA Medical, Plymouth, MN, USA
slide3

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

slide4

Silent Cerebral Infarctions (by MR)

2,040 Framingham Offsprings

(53% female; mean age, 62±9 years)

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

slide5

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

percutaneous pfo closure
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
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
patient flow intention to treat analysis
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

slide13

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%

slide14

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%

slide15

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%

slide16

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%

slide17

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

slide18

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%

slide19

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%

slide20

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%

slide21

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

slide22

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.