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Rionegro / 2013
Disclosures
Boris Pabon MD,        has received research support through Boston
Scientific, Cordis and Microvention, and has served as a consultant to
Chestnut Medical. Currently, perform proctoring activities to COVIDIEN.
Intracranial Endovascular Reconstruction of Cerebral
             Aneurysms with Pipeline



                    Boris Pabon MD,
Introduction
Endovascular treatment of intracranial aneurysms has
evolved substantially over the past two
decades, transitioning from an investigational therapy into routine clinical
practice and ultimately emerging as the treatment of choice for many lesions.

Despite this tremendous evolution in endovascular
therapy, some important limitations remain, particularly in
the treatment of wide- necked, large and giant, or “nonsaccular” fusiform
aneurysms.
Aneurysm Treatment Subject

Clinical series display aneurysm
recurrence due to long-term
coil effectiveness
Coiling 1994
DSA 2 yr Follow-Up
DSA 2 yr Follow-Up




                 3DA 15 yr Follow-Up
DSA -3D 15 year
  Follow-Up
Why are Flow-Diverter so exciting?

…This device does not function as previous self –
expanding stents (i.e. Neuroform ,Enterprise) in that it
is not designed to provide support to keep material
within an aneurysm dome; instead it appear to
function by excluding     the    aneurysm from      the
circulation.
Goal of Stents Treatment




      Circulatory Exclusion
PED Like a Flow-Diverter …




       Lieber BB, Seong J, Wakhloo AK,.J Biomech Eng. 2007 .
       Canton G, Levy DI, Lasheras JC, Nelson PK. J
       Neurosurg. 2005
Flow Diversion Features




PED
Endovascular Treatment Evolution
Intracranial             Flow Diverter            Endovascular
Aneurysms                  Devices                Reconstruction
What is the PED ?
The PED is a flexible, microcatheter- delivered, self-
expanding, endovascular “stent- like” construct engineered
specifically for the treatment of cerebral aneurysms . The
device consists of a braided mesh cylinder composed of 48
individual platinum and cobalt chromium microfilaments.
Pipeline Embolizaiton Device
• Structure: Metal Surface Area Coverage
  – Neuroform/Enterprise: 6.5 – 9.5%




  – PED: 30-35%
Pipeline Approach – Tips

 Pre procedure

   Procedure

     After procedure
Pre procedure
• Accurate Images ( DSA – 3DRA – CT angio/ MRI )
• Gastric protection
• Ranitidine better than Omeprazol
• Check the individual response to antiplatelets
                                      (Verify now)
• Check your PED’s Stock
• If you have any concern, then ASK !
• Confirm the presence of a 2nd Operator
• Corticoids load , to Giant or partially thrombosed lesions
Pre procedure
• Antiplatelets (Electively) :
ASA 100mg qd PO and, Clopidrogrel 75mg qd PO , Five
days before the procedure.

• Antiplatelets (Urgency) :
ASA 300mg PO and, if NGT available, Load dosis of
Clopidrogrel 600mg fractioned with almost 1h of interval.

• Antiplatelets (Emergency):
We recommend to use IIb-IIIa GP Inhibitors.
Procedure
• Check again all Images (Last time Findings …)
• Check again your PED’s Stock (avoid a heart attack !...)
• Confirm if the antiplatelet protocol is OK



Always be ready
for surprises….
Procedure
• Remember the Antiagregation, be careful during
femoral puncture
• Systemic Heparinazation (ACT >250 seg)
• Femoral Introducer sheath 6/8Fr.
• Coaxial Systems:
 6/8 Fr (Neuron / Chaperon) + Micro catheter Marksman
0.27in
Procedure
• Accepting a suboptimal material (guide, catheter, Micro wire)
can turn a 20 minutes case into a 4 hour nightmare.

• Put the Microcatheter more distally than you think would be right !

• Avoid to leave the Microcatheter tip near to the sharp curved
vessel : during PED implantation you will have a system backward
and the microwire would advance suddenly. (Perforation risk)

• Maintain constantly the forward tension of the PED, using the
torque device and, avoiding the kinking of the PED pusher.
Procedure
• keep in mind the PED foreshortening, again, it’s better to be
distally to avoid misplacement.

• For telescoping technique, never undersize the next device, you will
affect the construct. Try it not oversized !

• If the distal end of the stent remain close, you can rotate the wire
gently (no more than 3 cycles) or, you can try to advance the
microcatehter ; this simple maneuver would be enough to open it.

• Once you sure about the distal position , delivery the stent slowly
and gradually , specially at sharp angles.
Procedure
• Value the Hemodynamic effect , using a 25Fr/sec acquisition.

• Verify PED conformability. ( X-per CT / Dyna CT)

• Safeguard the distal access with the stent-wire at the end of the
procedure. Only, if you are satisfied with the result, so, pullback the
wire.

• Determine your strategy (1 or >1 PED)
Pipeline Deployment


                                                        • Slowly retract the
                                                          Marksman
                                                          microcatheter, mai
                                                          ntaining delivery
                                                          wire position
                            Microcatheter Distal
                            Marker
                                                          (applying slight fwd
                                                          tension)
Protective Coil
                  Distal market (bumper)

               Tip Coil




©2009 ev3 Inc. All rights
reserved. Contents are                             25
confidential.
Pipeline Deployment

                                             • Continue catheter
                                               retraction until 10
                                               to 15mm have
                                               been exposed and
                                               PED begins to
                                               “belly”
                                             • Maintain delivery
                     PED “bellying”
                                               wire position




©2009 ev3 Inc. All rights
reserved. Contents are                26
confidential.
Pipeline Deployment
                                             • Rotate delivery
                                               wire clockwise to
                                               facilitate PED
                                               expansion



                                             Distal      Proximal




©2009 ev3 Inc. All rights
reserved. Contents are               27
confidential.
Pipeline Deployment

                                                           • To reposition the
                                                             implant
                                                             backwards, pull
                                                             deliverywire so that
                                                             “bumper” corks
                                                             implant against
                            “Bumper” butted against
                                                             microcatheter
                            microcatheter                  • Pullback microcatheter
                                                             and deliverywire
                                                             together as a system




©2009 ev3 Inc. All rights
reserved. Contents are                                28
confidential.
Pipeline Deployment
                 • Continue
                   deployment of PED
                   by slowly pushing
                   out delivery wire
                 • To avoid
                   unexpected
                   movements, load
                   catheter while
                   pushing delivery
                   wire by applying
                   slight forward
                   tension
Pipeline Deployment
                                                          • Monitor the angle
                                                            of the PED exiting
                                                            the Marksman
                                                             – If the angle is too
                                                               shallow, the
                             Good deployment angle             Marksman is being
                                                               pulled too much;
                                                               push out delivery
                                                               wire
                                                             – If the angle is to
                                                               broad, the delivery
                                                               wire is being
                                                               pushed too much;
                                                               retract Marksman




©2009 ev3 Inc. All rights
reserved. Contents are                               30
confidential.
Pipeline Deployment
                                             • After deployment,
                                               advance
                                               Marksman over
                                               deliverywire to
                                               maintain access
                                             • If catheter tip gets
                                               caught on PED
                                               edge, advance the
                                               deliverywire to
                                               algin the proximal
                                               bumper at the tip
                                             • Use bumper as a
                                               catheter tip guide
                                               to negotiate PED
                                               edge

©2009 ev3 Inc. All rights
reserved. Contents are               31
confidential.
Pipeline Deployment

                                             • Slowly withdraw
                                               deliverywire
                                             • If distal bumper
                                               snags on
                                               Marksman tip,
                                               gently rotate
                                               clockwise




©2009 ev3 Inc. All rights
reserved. Contents are               32
confidential.
Pipeline Deployment
                                             • When telescoping
                                               2 PEDs ensure
                                               there is enough
                                               overlap to secure
                                               position
                                                – Start
                                                  conservative, you
                                                  can always pull
                                                  back if you are too
                                                  distal
                                                – Consider the “jump
                                                  back” as the PED
                                                  opens




©2009 ev3 Inc. All rights
reserved. Contents are               33
confidential.
Pipeline Deployment
                                             • Some times, pushing
                                               out delivery wire can
                                               cause the PED to not
                                               expand, specially if
                                               the catheter was not
                                               “loaded”
                                             • Continue to very
                                               slowly toggle
                                               between pulling back
                                               catheter and pushing
                                               out delivery wire




©2009 ev3 Inc. All rights
reserved. Contents are               34
confidential.
Pipeline Deployment
                                             • Even when all
                                               seems lost, as long
                                               as you maintain
                                               access, a complete
                                               flow diverter can be
                                               constructed (most
                                               of the times)




©2009 ev3 Inc. All rights
reserved. Contents are               35
confidential.
Pipeline Deployment




©2009 ev3 Inc. All rights
reserved. Contents are               36
confidential.
After procedure
• Be cautious with femoral access (Risk of retroperitoneal hematoma
and pseudoaneurysms)

• Clinical and radiological follow up 3, 6, 12

• Continue the gastric protection

• Dual antiplatelet regime (i.e. ASA + Clopidrogrel) for 6 m

• ASA lifetime

• Corticoids scheme in cases selected (Large/Giant lesions)
Clinical Cases
PED to Treat Very-Small Aneurysms
PED to Treat Blister-like Aneurysms
22mo FU
PED – Small Wide-neck Aneurysms

BA
65 y.o, Female.
History: Headache
Small L-Parophthalmic
unruptured aneurysm
Treatment: Stent Pipeline
6 mo FU
PED – Small /multiple Aneurysms
PED – Small /multiple Aneurysms
 DSA Pre treatment
                                   Stenting




Post Post treatment            3 Month F.U.
PED – Dysplasic Aneurysms




DSA Pre Treatment
9 Months Follow Up
PED – Giant aneurysms
57 YOF

Visual Loss
Headache
CT PRE




CT POST
55 YOF

6th CN Palsy
3 Month FU
63 YOF

Cavernous Syndrome
MRI Pre   MRI Post




          MRI 6 m F. Up
52 YOM

Trigeminal Neuralgia
     Headache
DSA immediately
DSA 6 month




                     PComA Jailed
                      Fully Open
PComA Jailed Fully
     Open
PED – Controlling Recanalization

C.A. - 1- 09-
59 y.o. female
Large R-Ophthalmic
 unruptured aneurysm.
16-12-2005 Coils.
14-12-2009PED
DSA 1 moFU
DSA 1 yr FU
PED – 24 month Follow-up
PED / Branching
PED : Vessel Reconstruction
Immediate post PED
3 months FU
TISS
Transient In-Stent Stenosis
PED – Transient In-Stent Stenosis

                 • Different than ISR
                   (Atherosclerosis)

                 • Inflammatory Reaction

                 • No Clinical Significance

                 • Parent Vessel Remodeling

                 • Etiology Uncertain
12 mo FU
PED - Results



World-wide Experience
Occlusion      Occlusion    Occlusion F.U.
    n:68      F.U. 3 m       F.U. 6 m       > 12 m
R
               ASD
E
           FU 42/63
S                     56%

U

L                                  83%
T

S
                                                92.1%
PED / Major Concern
PRE ROTATIONAL SCAN
POST STENTING
Stent delivery
Conclusions
The PED constituted easier strategy for treatment of selected
aneurysms than coiling. Essentially, eliminating the risk of
procedural rupture and complications related to the introduction
and manipulation of microcatheters or coils.

There are limitations related to existence of SAH and treatment of
bifurcation aneurysms. Specific trials are required to evaluate
this topic.

PED Experience is early. However, the existing clinical data have
been very encouraging. Based on our clinical experience, PED may
significantly improve the endovascular treatment of complex
aneurysms.
Take Home Messages
• Know the patient.
• Treat the patient; not only the artery.
• Learn from other people’s mistakes, better than
  learning from your own.
• Learn techniques from different people and then
  come up with your own.
• Keep it simple.
• Risk free Intracranial Stenting is not doing it.
• Recognize your limits; don’t push your luck
Thank you !
  Gracias

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Lima 2013 final

  • 2. Disclosures Boris Pabon MD, has received research support through Boston Scientific, Cordis and Microvention, and has served as a consultant to Chestnut Medical. Currently, perform proctoring activities to COVIDIEN.
  • 3. Intracranial Endovascular Reconstruction of Cerebral Aneurysms with Pipeline Boris Pabon MD,
  • 4. Introduction Endovascular treatment of intracranial aneurysms has evolved substantially over the past two decades, transitioning from an investigational therapy into routine clinical practice and ultimately emerging as the treatment of choice for many lesions. Despite this tremendous evolution in endovascular therapy, some important limitations remain, particularly in the treatment of wide- necked, large and giant, or “nonsaccular” fusiform aneurysms.
  • 5. Aneurysm Treatment Subject Clinical series display aneurysm recurrence due to long-term coil effectiveness
  • 7. DSA 2 yr Follow-Up
  • 8. DSA 2 yr Follow-Up 3DA 15 yr Follow-Up
  • 9. DSA -3D 15 year Follow-Up
  • 10. Why are Flow-Diverter so exciting? …This device does not function as previous self – expanding stents (i.e. Neuroform ,Enterprise) in that it is not designed to provide support to keep material within an aneurysm dome; instead it appear to function by excluding the aneurysm from the circulation.
  • 11. Goal of Stents Treatment Circulatory Exclusion
  • 12. PED Like a Flow-Diverter … Lieber BB, Seong J, Wakhloo AK,.J Biomech Eng. 2007 . Canton G, Levy DI, Lasheras JC, Nelson PK. J Neurosurg. 2005
  • 14. Endovascular Treatment Evolution Intracranial Flow Diverter Endovascular Aneurysms Devices Reconstruction
  • 15. What is the PED ? The PED is a flexible, microcatheter- delivered, self- expanding, endovascular “stent- like” construct engineered specifically for the treatment of cerebral aneurysms . The device consists of a braided mesh cylinder composed of 48 individual platinum and cobalt chromium microfilaments.
  • 16. Pipeline Embolizaiton Device • Structure: Metal Surface Area Coverage – Neuroform/Enterprise: 6.5 – 9.5% – PED: 30-35%
  • 17. Pipeline Approach – Tips Pre procedure Procedure After procedure
  • 18. Pre procedure • Accurate Images ( DSA – 3DRA – CT angio/ MRI ) • Gastric protection • Ranitidine better than Omeprazol • Check the individual response to antiplatelets (Verify now) • Check your PED’s Stock • If you have any concern, then ASK ! • Confirm the presence of a 2nd Operator • Corticoids load , to Giant or partially thrombosed lesions
  • 19. Pre procedure • Antiplatelets (Electively) : ASA 100mg qd PO and, Clopidrogrel 75mg qd PO , Five days before the procedure. • Antiplatelets (Urgency) : ASA 300mg PO and, if NGT available, Load dosis of Clopidrogrel 600mg fractioned with almost 1h of interval. • Antiplatelets (Emergency): We recommend to use IIb-IIIa GP Inhibitors.
  • 20. Procedure • Check again all Images (Last time Findings …) • Check again your PED’s Stock (avoid a heart attack !...) • Confirm if the antiplatelet protocol is OK Always be ready for surprises….
  • 21. Procedure • Remember the Antiagregation, be careful during femoral puncture • Systemic Heparinazation (ACT >250 seg) • Femoral Introducer sheath 6/8Fr. • Coaxial Systems: 6/8 Fr (Neuron / Chaperon) + Micro catheter Marksman 0.27in
  • 22. Procedure • Accepting a suboptimal material (guide, catheter, Micro wire) can turn a 20 minutes case into a 4 hour nightmare. • Put the Microcatheter more distally than you think would be right ! • Avoid to leave the Microcatheter tip near to the sharp curved vessel : during PED implantation you will have a system backward and the microwire would advance suddenly. (Perforation risk) • Maintain constantly the forward tension of the PED, using the torque device and, avoiding the kinking of the PED pusher.
  • 23. Procedure • keep in mind the PED foreshortening, again, it’s better to be distally to avoid misplacement. • For telescoping technique, never undersize the next device, you will affect the construct. Try it not oversized ! • If the distal end of the stent remain close, you can rotate the wire gently (no more than 3 cycles) or, you can try to advance the microcatehter ; this simple maneuver would be enough to open it. • Once you sure about the distal position , delivery the stent slowly and gradually , specially at sharp angles.
  • 24. Procedure • Value the Hemodynamic effect , using a 25Fr/sec acquisition. • Verify PED conformability. ( X-per CT / Dyna CT) • Safeguard the distal access with the stent-wire at the end of the procedure. Only, if you are satisfied with the result, so, pullback the wire. • Determine your strategy (1 or >1 PED)
  • 25. Pipeline Deployment • Slowly retract the Marksman microcatheter, mai ntaining delivery wire position Microcatheter Distal Marker (applying slight fwd tension) Protective Coil Distal market (bumper) Tip Coil ©2009 ev3 Inc. All rights reserved. Contents are 25 confidential.
  • 26. Pipeline Deployment • Continue catheter retraction until 10 to 15mm have been exposed and PED begins to “belly” • Maintain delivery PED “bellying” wire position ©2009 ev3 Inc. All rights reserved. Contents are 26 confidential.
  • 27. Pipeline Deployment • Rotate delivery wire clockwise to facilitate PED expansion Distal Proximal ©2009 ev3 Inc. All rights reserved. Contents are 27 confidential.
  • 28. Pipeline Deployment • To reposition the implant backwards, pull deliverywire so that “bumper” corks implant against “Bumper” butted against microcatheter microcatheter • Pullback microcatheter and deliverywire together as a system ©2009 ev3 Inc. All rights reserved. Contents are 28 confidential.
  • 29. Pipeline Deployment • Continue deployment of PED by slowly pushing out delivery wire • To avoid unexpected movements, load catheter while pushing delivery wire by applying slight forward tension
  • 30. Pipeline Deployment • Monitor the angle of the PED exiting the Marksman – If the angle is too shallow, the Good deployment angle Marksman is being pulled too much; push out delivery wire – If the angle is to broad, the delivery wire is being pushed too much; retract Marksman ©2009 ev3 Inc. All rights reserved. Contents are 30 confidential.
  • 31. Pipeline Deployment • After deployment, advance Marksman over deliverywire to maintain access • If catheter tip gets caught on PED edge, advance the deliverywire to algin the proximal bumper at the tip • Use bumper as a catheter tip guide to negotiate PED edge ©2009 ev3 Inc. All rights reserved. Contents are 31 confidential.
  • 32. Pipeline Deployment • Slowly withdraw deliverywire • If distal bumper snags on Marksman tip, gently rotate clockwise ©2009 ev3 Inc. All rights reserved. Contents are 32 confidential.
  • 33. Pipeline Deployment • When telescoping 2 PEDs ensure there is enough overlap to secure position – Start conservative, you can always pull back if you are too distal – Consider the “jump back” as the PED opens ©2009 ev3 Inc. All rights reserved. Contents are 33 confidential.
  • 34. Pipeline Deployment • Some times, pushing out delivery wire can cause the PED to not expand, specially if the catheter was not “loaded” • Continue to very slowly toggle between pulling back catheter and pushing out delivery wire ©2009 ev3 Inc. All rights reserved. Contents are 34 confidential.
  • 35. Pipeline Deployment • Even when all seems lost, as long as you maintain access, a complete flow diverter can be constructed (most of the times) ©2009 ev3 Inc. All rights reserved. Contents are 35 confidential.
  • 36. Pipeline Deployment ©2009 ev3 Inc. All rights reserved. Contents are 36 confidential.
  • 37. After procedure • Be cautious with femoral access (Risk of retroperitoneal hematoma and pseudoaneurysms) • Clinical and radiological follow up 3, 6, 12 • Continue the gastric protection • Dual antiplatelet regime (i.e. ASA + Clopidrogrel) for 6 m • ASA lifetime • Corticoids scheme in cases selected (Large/Giant lesions)
  • 39. PED to Treat Very-Small Aneurysms
  • 40. PED to Treat Blister-like Aneurysms
  • 42. PED – Small Wide-neck Aneurysms BA 65 y.o, Female. History: Headache Small L-Parophthalmic unruptured aneurysm Treatment: Stent Pipeline
  • 44. PED – Small /multiple Aneurysms
  • 45. PED – Small /multiple Aneurysms DSA Pre treatment Stenting Post Post treatment 3 Month F.U.
  • 46. PED – Dysplasic Aneurysms DSA Pre Treatment
  • 47.
  • 48.
  • 50. PED – Giant aneurysms
  • 52.
  • 53.
  • 55. 55 YOF 6th CN Palsy
  • 56.
  • 57.
  • 60.
  • 61.
  • 62.
  • 63.
  • 64. MRI Pre MRI Post MRI 6 m F. Up
  • 66.
  • 67. DSA immediately DSA 6 month PComA Jailed Fully Open
  • 69. PED – Controlling Recanalization C.A. - 1- 09- 59 y.o. female Large R-Ophthalmic unruptured aneurysm. 16-12-2005 Coils. 14-12-2009PED
  • 70. DSA 1 moFU DSA 1 yr FU
  • 71. PED – 24 month Follow-up
  • 73. PED : Vessel Reconstruction
  • 77. PED – Transient In-Stent Stenosis • Different than ISR (Atherosclerosis) • Inflammatory Reaction • No Clinical Significance • Parent Vessel Remodeling • Etiology Uncertain
  • 80. Occlusion Occlusion Occlusion F.U. n:68 F.U. 3 m F.U. 6 m > 12 m R ASD E FU 42/63 S 56% U L 83% T S 92.1%
  • 81. PED / Major Concern
  • 83.
  • 84.
  • 87.
  • 88.
  • 89. Conclusions The PED constituted easier strategy for treatment of selected aneurysms than coiling. Essentially, eliminating the risk of procedural rupture and complications related to the introduction and manipulation of microcatheters or coils. There are limitations related to existence of SAH and treatment of bifurcation aneurysms. Specific trials are required to evaluate this topic. PED Experience is early. However, the existing clinical data have been very encouraging. Based on our clinical experience, PED may significantly improve the endovascular treatment of complex aneurysms.
  • 90. Take Home Messages • Know the patient. • Treat the patient; not only the artery. • Learn from other people’s mistakes, better than learning from your own. • Learn techniques from different people and then come up with your own. • Keep it simple. • Risk free Intracranial Stenting is not doing it. • Recognize your limits; don’t push your luck
  • 91. Thank you ! Gracias