C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T Presenter disclosure information name: Frank Uhlemann In the last 12 month.

C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T

Presenter disclosure informationname: Frank Uhlemann

In the last 12 month the presenter had contact to thefollowing companies. There is no conflict of interests

company contactAbbott consultant F.UhlemannSt. Jude medical consultant F.Uhlemann

C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T

Interventional PFO-Closure Using The Premere DeviceA Single-Center Experience

F. UhlemannCenter for Congenital Heart Disease Stuttgart

OlgahospitalAdvanced Angioplasty 2007 London 26th January

C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T

Device design

Tether

Lock

Delivery System Release Mechanism

Left Atrial Anchor

Right Atrial Anchor

C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T

Device - Optimal anatomic adaptation

long Track

Keypoints:flexible length of connection between both anchorslow content of metalslim design especially on left sideSeparate steerability of left and right atrial anchor

Sizes:(15mm), 20mm and 25mm diameter

short Track

C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T

30 day porcine implant

left atrial anchor

right atrial anchor

Device - rapid and complete endothelialisation

C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T

Procedure - the way we do it in Stuttgart Pre intervention

complete neurologic workupworkup for coagulation disorders, e.g. thrombophiliaTOE with bubble study and Valsalva

During interventionsedation on demandfull heparinisation (100 IU/kg, single dose)short term antibiotic prophylaxis

Post interventionheparinisation for 24 hours

Drugs: commencing 12h post implantationaspirin (low dose) and clopidogrel for 3monthsaspirin (low dose) for next 3 months

Follow up examinations (ecg, echo, holter-ecg, clinical):3-4 weeks (TOE for thrombus formation)6 months (TOE for complete closure)1 year

C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T

Procedure - balloonsizing „sense or nonsense“low pressure balloon, TOE, echo contrast and abdominal pressure

pro: to get an idea of the track morphology, diameter, stiffness, lengthto exclude additional defects

con: expensive, need for longer TOE

What you can miss without echo guidance:Chiari networklarge Eustachian valveoverriding of SVCpartial anomalous pulmonary venous drainage

subdivided left atrium

We perform balloon sizing in every patient

We recommend echo guidance in every patient

C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T

The way we do it – intervention/balloonsizinglong track versus short track

waist at waist at different levels same level

C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T

Deployment of device - stepsdeployment of left atrial anchor

„free floating“ in left atriumself orientation towards the septum

deployment of right atrial „patched“ anchorindividual steerability and option for repositioning

C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T

Deployment of device - steps locking of both parts and opening of snaretrue image of the final position before final release

final releasecutting the tether, superior conformability

C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T

Interventional closure of pFO – patients -device selection

n = 69

18

13

2

49

17

0%

20%

40%

60%

80%

100%

period 1 period 2

Premere 20 Premere 25 other device

Implantation periodsperiod 1:from 10/2004 to 05/2005

only 20mm Premere device available

period 2:from 06/2005 to 08/2006

20mm and 25mm device available device selection according to patients anatomy

patients99 patients with intention for closure - 99 patients successful closure procedure69 patients suitable for Premere device and enrolledAge (years): mean +/-SD 46,10 +/- 11,05Range (20 – 75)Male sex % (n) 49,3 (34)

History of cryptogenic ischaemic stroke % (n) 41,8 (29) transient ischaemic attack % (n) 58,2 (40)

Follow upmean follow up 11,1 months

C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T

Results - closure rate

92 9489

86

95 96

0

20

40

60

80

100

immediate 3weeks 6months

(%)

overall 20mm 25mm

?to our understandingat early stage irrelevant

C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T

Results - complications69 patients with Premere device

major complications: device embolisation 1**need for surgery nonethrombus formation left side nonecerebral events 1 TIA*

* despite successful closure** without clinical symptoms

minor complications: bleeding (need for transfusion) nonethrombus formation right side nonerhytm disturbances permanent nonerhytm disturbances intercurrent 1

need for drug 1

C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T

Current limitations for 25mm Premere device

pFO morphologywide opening of right or left side of the track (entrapment of the anchor) >15mmvery large aneurysm

left right shunting (debatable)multiperforated pFO

C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T

Summary- interventional closure of pFO

Premere device (St. Jude Medical)•good closure rate•suitable for about 70% of our unselected patient group•easy implantation procedure•excellent adaptation to individual anatomy•rapid endothelialisation•low complication rate

C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T

Thank you

C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T

interventional closure of pFO

C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T

interventional closure of pFO

C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T

interventional closure of pFO