Keypoints when treating short necks - linc2019.cncptdlx.com › media › 1138_Fabio... · 2...
Transcript of Keypoints when treating short necks - linc2019.cncptdlx.com › media › 1138_Fabio... · 2...
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Keypoints when treating short necks
Prof. Fabio Verzini, MD, PhD, FEBVS
University of Turin, Italy
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Disclosure
Speaker name:
...............Fabio Verzini...............................................
I have the following potential conflicts of interest to report:
Consulting for Cook, Gore, Medtronic
Employment in industry
Stockholder of a healthcare company
Owner of a healthcare company
Other(s)
I do not have any potential conflict of interest
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UNFAVORABLE PROXIMAL AORTIC NECK ANATOMY
Short Tapered Thrombus lined
Wide Angulated Calcified
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UNFAVORABLE PROXIMAL AORTIC NECK ANATOMY
Short Tapered Thrombus lined
Wide Angulated CalcifiedPOTENTIAL FACTORS THAT MAY IMPACT EVAR DURABILITY
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Neck Length and EVAR Performance
…infrarenal neck length <15 mm is
associated with significantly increased risk
of short and midterm endoleaks…
Leurs et al. J Endovasc Ther 2006;13:640–648
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Neck Length and EVAR Performance
…infrarenal neck length <15 mm is
associated with significantly increased risk of
short and midterm endoleaks…
Freedom From Proximal Type I EL
>15mm
11-15mm
≤10mm
Leurs et al. J Endovasc Ther 2006;13:640–648
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Neck Diameter and EVAR Performance
…EVAR performed in AAAs with large necks is
associated with a significant neck enlargement at
24 months and higher risk of type Ia EL and neck
related reinterventions
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Neck Angulation and EVAR Performance
…aortic curvature should be a better parameter
than angulation to predict post-EVAR failure
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Neck Anatomy and Adherence to IFU
Retrospective 2-center study
(2005-2014)
461 patients
Graft related adverse events (GRAEs):
- reintervention
- graft migration
- EL (excluded type II)
- rupture
- limb occlusion
- sac growth
- aneurysm-related mortality
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Neck Anatomy and Adherence to IFU
A total of 43.8% of
patients undergoing
EVAR had a device-
specific IFU violation
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Neck Anatomy and Adherence to IFU
Kaplan-Meier freedom
from GRAEs for non-
adherence to proximal
aortic neck IFU
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(< 15 mm)
(< 10 mm)
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Influence of Multiple Hostile Neck Parameters
PROXIMAL SEAL COMPLICATION RISKS INCREASE AS THE NUMBER OF HOSTILE NECK PARAMETERS INCREASE 1
Neck hostility
Intra-op
adjunctive
procedures
Intra-op
endoleaks
All cause
mortality
On label 9.9% 0.5% 1.1%
2 hostile neck
parameters26.7% 6.7% 13.3%
>2 hostile neck
parameters 50% 16.7% 16.7%
More than 1 hostile neck parameter substantially increases mortality, major
adverse events, intra-op endoleaks and adjunctive procedures
1 Speziale F et al, Ann Vasc Surg. 2014, doi:
10.1016/j.avsg.2014.06.057.
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…in Short Diseased Neck
NO COMPROMISE in elective cases
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No compromise on the best neck choice
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No compromise on the best neck choice
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Maximize sealing zone
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Clinical Data
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Mayo ClinicG. Oderich
UCSFL. Reilly
Cleveland ClinicS. Lyden
MGHC. Kwolek
U PennR. Fairman
UNCM. Farber
Wash UG. Sicard
UWB. Starnes
NYUN. Cayne
U FloridaA. Beck
Indiana UA. Shahriari
U PittsburghM. Makaroun
Dartmouth-Hitchcock MCM. Fillinger
U MassA. Schanzer
Zenith Fenestrated AAA Endovascular Graft –
U.S. Multicenter Study
67 patients in the pre-market
phasesPivotal phase: 42 patients 2005/2010
Continued access phase: 25 patients
2010 2012
21 patients in the post-market
phase
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Clinical Data
100% Technical Success
“Repair of Juxtarenal AAAs with Zenith
Fenestrated is Safe and Effective.”1 Patient Reported with Type 1a Endoleak at 3 Years
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• 30-day mortality: 1.5% (1/67)
Bowel ischemia (procedure-related)
• Major adverse events: bowel ischemia in 2 other patients
Both had complete resolution after medical treatment
• No conversion, rupture, or renal function deterioration
• Pre-discharge CTA
– All target arteries patent
– No type I or III endoleaks
– 16 patients (29%) had type II endoleaks
• Mean hospital stay
– 3.3 ± 2.1 days (range, 1-14 days)
Early Outcomes (Within 30 Days)
Oderich GS, et al. J Vasc Surg. 2014;60(6):1420
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• 4 late deaths not related to aneurysm
• 9 late major adverse events not related to aneurysm
• No late ruptures, conversion to open repair, or dialysis
• No type III endoleak, only 1 case of type I endoleak
• Renal outcomes3 patients with renal function deterioration (serum creatinine rise to >2 mg/dL and
>30% from baseline, detected on two or more follow-up tests)
4 renal stent occlusions (3% of targeted renal arteries)12 renal stent stenoses (9% of targeted renal arteries)
• Re-interventions were needed in 15 patients (22%)11 for renal stenosis/occlusion
4 for endoleak (3 for type II endoleak; 1 for type I endoleak)
Late Outcomes
Mean follow-up: 37 ± 17 months (range, 3-65 months)
Oderich GS, et al. J Vasc Surg. 2014;60(6):1420
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Patency of Targeted Renal Arteries
0
20
40
60
80
100
0 1 2 3 4 5Years
Secondary
Primary
No. at risk: 129 117 86 51 31 23
No. at risk: 129 121 91 55 35 26
Prim
ary
an
d s
eco
nd
ary
pate
ncy (
%) 81 ± 5%
97 ± 2%
Patency measures (defined a posteriori):
• Primary patency: uninterrupted patency from index procedure until
occlusion or reintervention for renal stent stenosis
• Secondary patency: time to occlusion treated by surgical bypass or
not suitable to endovascular salvage
Oderich GS, et al. J Vasc Surg. 2014;60(6):1420
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The use of fenestrated devices to treat juxtarenal and group IV TAAA is safe and effective in long term follow-up:
aortic related mortality was 2%, patency of 95% and freedom from re-intervention rate of 86,7% at 3 years
610 patientsMean follow up of 8 years
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FEVAR to treat short neck, juxtarenal and suprarenal aneurysm is associated with high technical success and low operative mortality rate
281 patientsMean follow up 21 months
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…f-EVAR for the treatment of patients with JAAA is
a durable procedure with good long term outcomes
in terms of mortality and visceral vessel patency.
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Waiting time...?
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Chimneys will reduce the sealing zone
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Fenestrated grafts will not interfere with the active fixation
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Chimneys interfere with the active fixation
Risk of late migration?
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Olcclusion risk for the superior mesenteric?
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Risk of conflict between renal stent and aortic stent?
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Role of ch-EVAR
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Role of endoanchors
…this device mitigates
the adverse effect of
wide infrarenal necks
with a significant
improvement of 2-year
sac regression.
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Conclusion
• F-EVAR guarantees the best long-term outcomes in patients with short proximal neck
• Visceral (renal) long term patency still an issue
• Strict FU is mandatory to prevent long term complications
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Keypoints when treating short necks
Prof. Fabio Verzini, MD, PhD, FEBVS
University of Turin, Italy