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
