evolution of endovascular aneurysm treatment: the good ... › app › files › public › ... ·...
TRANSCRIPT
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Evolution of Endovascular Aneurysm Treatment: The Good,
the Bad and the Ugly
Mary E. Jensen, M.D. Director, Interventional Neuroradiology Professor of Radiology, Neurology and
Neurological Surgery University of Virginia Health System
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Consultant, Stryker Neurovascular, Inc Educational Speaker, Covidien Core Reading Lab, Microvention, Inc
Disclosures
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History of Endovascular Aneurysm Treatment, B.C.
• Werner, 1941: silver wire insertion through the orbit
• Lussenhop and Velasquez, 1964: carotid navigation with silastic tubing
• Kessler and Wholey, 1970: carotid occlusion with balloon catheter
• Hilal, 1974: magnetic-tipped microcatheter used to navigate intracranial vessels
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Meanwhile in the USSR. . . • 1962: non-detachable
balloon catheter • 1964: TBO of ICA • 1969: txd CCF with
N-D BC • 1974: first English
paper on use of detachable balloons
Dr. Fedor Serbinenko
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Latex Balloons
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Parent Artery Occlusion
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Reconstructive Therapy • Reconstructive therapy
– Intrasaccular occlusion of aneurysm with preservation of parent artery
• Requires supple microcatheter to reach the aneurysm
• Requires embolic device that is pliable but stable, and detachable
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Cavernous Aneurysm
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Dowd DF, Halbach VV, Higashida RT, Barnwell SL, Hieshima GB. Endovascular coil embolization of unusual posterior inferior cerebellar artery aneurysms. Neurosurgery 1990
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Development of the Guglielmi Detachable Coil (GDC)
• Guido Guglielmi, MD (Univ of Rome)
• Developed 1988-1991 in conjunction with Ivan Sepetka, Target Therapeutics, and Fernando Vinuela, MD (UCLA)
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GDC: Design • Design considerations
– Radiopaque – Low profile (for use in 0.018”
systems) – Flexible (navigate carotid
siphon) – Soft (minimize perforation
risk) – Retrievable – Size-matched to aneurysms
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GDC: Original Design
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GDC: Clinical Trial • First patient treated in March, 1990 • 20 centers participate in clinical trials, 1992-1995 • Non-surgical candidates • FDA approval September, 1995
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Clinical Results (Vinuela, ASNR 1995)
• 715 patients as part of FDA trial – 48% SAH, 25% mass effect; 15% giant – 58% ant circulation, 42% post circulation
• Radiographic outcomes – Complete occlusion seen in 62% of small
aneurysms with small neck – 35% for aneurysms with broad neck – 37% of large aneurysm with small neck
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FDA Approval Sept 1995 • Only for non-surgical or high-risk patients
– GOOD • First safe and effective reconstructive device for
EVT of aneurysms • Required training and proctoring
– BAD • Limited coil sizes and shapes • ? Durability • Few trainers/proctors
– UGLY
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Solving Problems: 1995-2003
• Wide-necked and fusiform aneurysms difficult
• Delicate system – coil unraveling,
fracture, migration • Coil compaction
– neck remnants – regrowth
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Initial Tx and 6 M Post
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Better Coils (2000) • Different sizes/lengths (2 mm - 20mm) • Different stiffnesses (GDC 10 and GDC 18) • Different shapes (2D coils, framing coils) • Stretch resistance
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GDC 3D Technology
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New Companies
• More variety, more products – Micrus (1996): Micrusphere (2000) – Microvention (1997): Microplex (2002) – Cordis/Codman: Trufill DCS Orbit (2002) – Dendron/MTI (2002): Sapphire (2003)
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GDC Delivery steel wire
TRUFILL DCS ORBIT™ Delivery soft polymer tube
MICRUS MicruSphere Delivery Wire
GDC 10 US SR SynerG Delivery Wire
MTI Sapphire Delivery Wire
Transition Zones
Microvention V-Trak
Photos taken at Cordis Neurovascular and owned by CNV.
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Surface Coatings
• Can we increase “biological activity” of platinum by adding surface coatings?
• Can this be done without changing – thrombogenicity – softness – radiopacity
• How much can be delivered? – 50µ thickness coating = 3% of aneurysm volume
• Will it cause complications?
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Coil Coatings: PGLA
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Coil Coatings: Hydrogel
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Explanted Aneurysm Close-Up of Neck Area
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12 y.o. in MVA with CHI and Proptosis/Bruit
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Fistula closed with Hydrocoil/ Bare Platinum
82% by length, 91% by volume of hydrocoil
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Five Days and 2 M Post
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Trial Outcomes of Coated Coils
• Cerecyte Trial – Bare platinum vs Cerecyte
• No benefit of Cerecyte over BP • Increased complications (5.4% vs 0.8%) in ruptured
• Matrix and Platinum Coil Trial – No difference in recurrence with similar rates of
reintervention (10%) • Hydrocoil Endovascular Aneurysm
Occlusion and Packing Study – Rate of major angiographic recurrence was
slightly lower in HC group (24 v 34%; p=0.049)
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New Techniques: Balloon Remodeling
Cordis Commodore (left) and Boston Scientific Sentry (top) silicone balloons
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Stent-Assisted Coil Embolization
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Differences Between Stents • Neuroform
– Open cell design – Follows wall contour – Scales may open
into neck – Cannot recapture
• Enterprise – Closed cell design – Kinks along curves – Better coverage of
neck – Able to recapture
before 70% of stent delivered
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Differences Between Stents
• Neuroform – Open cell design – Follows wall contour – Scales may open
into neck – Cannot recapture
• Enterprise – Closed cell design – Kinks along curves – Better coverage of
neck – Able to recapture
before 70% of stent delivered
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Differences Between Stents • Neuroform
– Open cell design – Follows wall contour – Scales may open
into neck – Cannot recapture
• Enterprise – Closed cell design – Kinks along curves – Better coverage of
neck – Able to recapture
before 70% of stent delivered
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Stent “Scale” Lassoed By Coil
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Expansion of the Field
• GOOD – More variety – More competition (?) – More ideas (no matter how
crazy!) • BAD
– More expensive devices with only theoretical benefit
– More elaborate treatments – More marketing
• UGLY
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ISAT
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International Subarachnoid Aneurysm Trial (Lancet, 2002)
• Coil vs clip in 2143 pts with aSAH • At 1 yr, 23.7% coil and 30.6% clip pts were
dead or dependent • Trial stopped prematurely b/c disability-free
survival at one year was better in coiled pts • Risk of seizures lower in coiled group • Risk of late rebleeding is low (0.2%) • GDC approved for all indications in 2003
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Trends of Utilization of Coiling vs Clipping, 2000-2006
Alshekhlee A; Stroke 41:1471;2010
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Widespread Adaptation
• GOOD – More patients being treated endovascularly with
lower complication rates – Field advances
• BAD – “Turf wars” – “Hurry up” training programs – Little cooperation amongst subspecialties
• Took one year for Radiology and Neurosurgery to agree to ACGME fellowship name: “Endovascular Surgical Neuroradiology”
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Hui F et al. A history of detachable coils:1987-2012 JNIS 2013
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Coil Focus
• Longer coil lengths • Different primary winds • Larger diameter coil cross-section • Delivery wire/detachment zone modifications
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Onyx Aneurysm Treatment
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Flow Diversion
Kallmes DF, et al., A new endoluminal, flow-disrupting device for treatment of saccular aneurysms. Stroke 2007;38:2346-52
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Meta-analysis of UIA and PED Literature (Murthy et al J Clin Neurosciences 2013)
• 13 studies; 905 pts, 1043 aneurysms • Mean aneurysm diameter = 11.1 mm • 37% large; 10% giant • Cumulative mortality rate: 2.3% • Stroke = 1.9% • TIA = 2% • ICH = 2.3% • 6 m cumulative event rate: 16.7% • 6 m aneurysm occlusion rate: 79.7%
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NICE Recommendations (Nat’l Institute for Clinical Effectiveness) • Evidence supports its use in pts with giant or
complex aneurysms unsuitable for surgery, where large number of coils would be needed for stent-assisted coiling
• Only becomes cost beneficial in cases where >32 coils would be used
• Discussions with clinical experts suggested the number of patients estimated by Covidien to be suitable for treatment with PED was excessively high
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Blister Aneurysm of Basilar Artery
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Treatment with PED
PRE-PIPELINE
IMMEDIATE POST
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Unsubtracted Image of Device
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DynaCT With Good Wall Apposition
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10 Days Post Pipeline
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Day 18 Post Treatment • Pt awoke with L
hemiparesis • Emergent CTA
shows device open, no filling of aneurysm
• Emergent DWI shows R paramedian pontine infarct
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35 Days Post Pipeline
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35 Days Post Pipeline
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35 Days Post Pipeline
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Post Stenting with Enterprise 28 and 22
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2x1 HS and 8 D Post
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With Increased Complexity Comes Increased Risk!
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Comparison of NF and ENT Stents in UIA
• 130 UIA – 53 ENT, 77 NF – 94% technical success rate
• Morbidity – 15% ENT, 3% NF (p=0.020)
• Multivariate analysis – Use of NF predictive of retreatment (p=0.034) – Type of stent was not predictive of clinical outcome as
measured by mRS Durst et al Clinical Radiology 2013
![Page 66: Evolution of Endovascular Aneurysm Treatment: The Good ... › app › files › public › ... · • Coil vs clip in 2143 pts with aSAH • At 1 yr, 23.7% coil and 30.6% clip pts](https://reader030.vdocuments.mx/reader030/viewer/2022040615/5f0d3d217e708231d4395b46/html5/thumbnails/66.jpg)
Dual Catheter Technique
• Technique used for wide-necked aneurysms – “Weaving” of two coils concurrently – Placement of framing coil without detaching
followed by filling from second catheter • Advantages
– No need for balloon catheter or stent – No need for antiplatelet agents
![Page 67: Evolution of Endovascular Aneurysm Treatment: The Good ... › app › files › public › ... · • Coil vs clip in 2143 pts with aSAH • At 1 yr, 23.7% coil and 30.6% clip pts](https://reader030.vdocuments.mx/reader030/viewer/2022040615/5f0d3d217e708231d4395b46/html5/thumbnails/67.jpg)
Basilar Tip Aneurysm Working Projections
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1st and 2nd Positions 7 x 20 Penumbra and After Removal of 5 x 9 Penumbra
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Coil Retrieval with 4 mm Alligator Snare
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Dual Catheter Technique with Stryker XL Coils
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Pre 1 (XL 7 x 20)/2(5 x 20 S); 1/4 (3x8 US); 1/5 (2x6 US)
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Final Post
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8M Gd MRA MIPs
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Dual Catheter Technique
• 100 consecutive pts with wide-necked aneurysms
• Technical success rate: 91% • Morbidity: 1%, mortality: 2% • Clinical outcomes
– 93% demonstrating mRS 0-2 regardless of score at presentation
• Retreatment rate: 18% Durst et al J Neurosurg Aug 2014
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Treatment of Very Small Aneurysms
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64 yo F with Ruptured Basilar Tip Aneurysm
2.25 H X 1.8 W X 1.8 D WITH 1.8 NECK
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1.5 X 3 360 US
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1 X 2 360 US
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Post 2 Weeks
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39 yo F with Ruptured Basilar Tip Aneurysm
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2.5 x 4 360 2 x 3, 1.5 x 2 (2) 360 1.5 x 2 360 2.5 x 4, 2 x 3 360
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Follow-Up Study 10 Days Later
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1.5 x 2 360 1.5 x 2 360 1 x 2 HELICAL
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Post 18 Months Tx MRA
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Corresponding Angiogram
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52 yo Male with Ruptured AComA
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Dual Catheter Technique
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Coil Ball Impingement
3 x 8, 2 x 6 360 1.5 x 3 360
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Non-Occlusive Thrombus
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Eight Days and Six Months Post Treatment
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Comparison of NF and ENT Stents in UIA
• 130 UIA – 53 ENT, 77 NF – 94% technical success rate
• Morbidity – 15% ENT, 3% NF (p=0.020)
• Multivariate analysis – Use of NF predictive of retreatment (p=0.034) – Type of stent was not predictive of clinical outcome as
measured by mRS Durst et al Clinical Radiology 2013
![Page 92: Evolution of Endovascular Aneurysm Treatment: The Good ... › app › files › public › ... · • Coil vs clip in 2143 pts with aSAH • At 1 yr, 23.7% coil and 30.6% clip pts](https://reader030.vdocuments.mx/reader030/viewer/2022040615/5f0d3d217e708231d4395b46/html5/thumbnails/92.jpg)
Dual Catheter Technique
• Technique used for wide-necked aneurysms – “Weaving” of two coils concurrently – Placement of framing coil without detaching
followed by filling from second catheter • Advantages
– No need for balloon catheter or stent – No need for antiplatelet agents
![Page 93: Evolution of Endovascular Aneurysm Treatment: The Good ... › app › files › public › ... · • Coil vs clip in 2143 pts with aSAH • At 1 yr, 23.7% coil and 30.6% clip pts](https://reader030.vdocuments.mx/reader030/viewer/2022040615/5f0d3d217e708231d4395b46/html5/thumbnails/93.jpg)
Basilar Tip Aneurysm Working Projections
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1st and 2nd Positions 7 x 20 Penumbra and After Removal of 5 x 9 Penumbra
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Coil Retrieval with 4 mm Alligator Snare
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Dual Catheter Technique with Stryker XL Coils
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Pre 1 (XL 7 x 20)/2(5 x 20 S); 1/4 (3x8 US); 1/5 (2x6 US)
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Final Post
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8M Gd MRA MIPs
![Page 100: Evolution of Endovascular Aneurysm Treatment: The Good ... › app › files › public › ... · • Coil vs clip in 2143 pts with aSAH • At 1 yr, 23.7% coil and 30.6% clip pts](https://reader030.vdocuments.mx/reader030/viewer/2022040615/5f0d3d217e708231d4395b46/html5/thumbnails/100.jpg)
Dual Catheter Technique
• 100 consecutive pts with wide-necked aneurysms
• Technical success rate: 91% • Morbidity: 1%, mortality: 2% • Clinical outcomes
– 93% demonstrating mRS 0-2 regardless of score at presentation
• Retreatment rate: 18% Durst et al J Neurosurg Aug 2014
![Page 101: Evolution of Endovascular Aneurysm Treatment: The Good ... › app › files › public › ... · • Coil vs clip in 2143 pts with aSAH • At 1 yr, 23.7% coil and 30.6% clip pts](https://reader030.vdocuments.mx/reader030/viewer/2022040615/5f0d3d217e708231d4395b46/html5/thumbnails/101.jpg)
Treatment of Very Small Aneurysms
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64 yo F with Ruptured Basilar Tip Aneurysm
2.25 H X 1.8 W X 1.8 D WITH 1.8 NECK
![Page 103: Evolution of Endovascular Aneurysm Treatment: The Good ... › app › files › public › ... · • Coil vs clip in 2143 pts with aSAH • At 1 yr, 23.7% coil and 30.6% clip pts](https://reader030.vdocuments.mx/reader030/viewer/2022040615/5f0d3d217e708231d4395b46/html5/thumbnails/103.jpg)
1.5 X 3 360 US
![Page 104: Evolution of Endovascular Aneurysm Treatment: The Good ... › app › files › public › ... · • Coil vs clip in 2143 pts with aSAH • At 1 yr, 23.7% coil and 30.6% clip pts](https://reader030.vdocuments.mx/reader030/viewer/2022040615/5f0d3d217e708231d4395b46/html5/thumbnails/104.jpg)
1 X 2 360 US
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Post 2 Weeks
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39 yo F with Ruptured Basilar Tip Aneurysm
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2.5 x 4 360 2 x 3, 1.5 x 2 (2) 360 1.5 x 2 360 2.5 x 4, 2 x 3 360
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Follow-Up Study 10 Days Later
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1.5 x 2 360 1.5 x 2 360 1 x 2 HELICAL
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Post 18 Months Tx MRA
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Corresponding Angiogram
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52 yo Male with Ruptured AComA
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Dual Catheter Technique
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Coil Ball Impingement
3 x 8, 2 x 6 360 1.5 x 3 360
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Non-Occlusive Thrombus
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Eight Days and Six Months Post Treatment
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69 yo F with SAH
5 coils: 5 – 2.5 360 US
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Six Month F/U
TOF GAD
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4 x 10 360 US 3 x 6 360 US/2.5 X 4 HEL US 2 X 3 360 US
Progressive Filling
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Final Post
Post 1 x 2 360 US
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F/U MRA 2Y Post Retreat
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Pre Post 4 coils 6 month f/u
55 yo F with Recurrence Following Coiling for SAH
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1.5 x 4 360 US 1 X 3 360 US
“Weaving” of Two Coils
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Final Post
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TOF MRA 1Y Post
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Observations
• New tiny, softer coils fills the niche of a complex shape in very small diameter – Treat small aneurysms more effectively
• Prevents multiple manipulations of the aneurysm while trying to find a 2 mm that fits
• Stable complex neck coverage • More robust construct because of radial support
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Observations
• Very soft – Pack densely within the coil ball in a precise
location • “Plays well with others”
– Does not displace other coils while packing or retrieving
– Works well for “weaving” with dual catheter technique
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Potential Drawbacks
• “Snaking” in catheter – May jam against RHV on guide, injuring the
coil – More common with longer coils
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Take Home Messages • "Nihil simul inventum est et perfectum” (Nothing
is invented and perfected at the same time) – Don’t be too eager to “be the first”
• Keep it simple – Don’t start with the complex plan – Be patient and work that coil
• Recognize that you cannot be all things to all people – Have a command of at least one coil system before
“trying out” new devices
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56 yo M with Strong Family Hx of Ruptured Aneurysms
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Working Projections
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Pre 1A, Pre 1B
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Pre 2/Post 2
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Take Home Messages
• Being involved with a new technology is exhilarating – Opens doors to collaboration, publication and
invention – Protect yourself, your work, your institution
and your patients • Technology isn’t disruptive—people are
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Take Home Messages
• Public actions can have personal consequences – Working with industry – Working with government panels – Working with societies
• Be kind to everyone—you never know when you might need their help