View Presentation - Cleveland Clinic

Type 2 Endoleaks –
Clinically important or just a fad?
Greenberg Stent Summit
September 1, 2016
Matthew P. Sweet, MD
Assistant Professor
Division of Vascular Surgery
University of Washington
Disclosures
Consultant:
Arsenal Medical
Recipient of Honoraria:
Cook Medical
Medtronic
Type 2 EL after t-Branch
• January 2012 - 78 y/o man
presented with a 6.3 cm
extent 1 TAAA
• October 2012 – t-Branch
repair done
• On ASA and statin
*
Pre-op
6.3 cm
18 Months
6.8 cm
With T2EL
2 years
7.7 cm
With T2EL
*
2.3 years
8 cm
With T2EL
3 years
9.1 cm
With T2EL
* Trans-thoracic coil embolization
What is the incidence of T2EL?
What clinical impact do they have?
Cook Zenith Data
Pivotal
5 year results of Pivotal &
Continued Access
Years
2000-2001
2000-2003
# patients treated
200
736
% of T2EL at 1 year
5%
7%
# treated for T2EL with sac
expansion throughout the
5 year follow up
5 (3%)
20 (3%)
1. No deaths due to T2EL
2. 67 re-interventions for T2EL, but only 20 were
associated with sac enlargement
Greenberg JVS 2004
Greenberg JVS 2008
Medtronic Pivotal Studies
5 Year Results
Talent
Endurant
Years
# patients treated
2002-2003
166
2008-2009
150
% of T2EL at 1 year
17%
16%
# treated for T2EL with sac
expansion throughout the 5
year follow up
10 (6%)
10 (7%)
Number of indeterminate EL
5 (3.7%)
4 (2.7%)
1. No deaths due to T2EL
2. No difference in incidence between studies
Turnbull JVS 2010
Singh JVS 2016
OVER Randomized Clinical Trial
• 439 EVAR procedures done at 42 VA Medical centers
in the USA between 2002-2011
• Mean f/u of 6.2 +/- 2.4 years
• 135 patients with endoleak (30.5%)
– 111 (25%) had T2EL
– 60% of the T2EL resolved on their own
– 36 (8%) re-interventions performed for T2EL
• 4 ruptures - None due to T2EL, all due to T1EL
• Delayed onset T2EL (after 1 year) were associated
with aneurysm enlargement, but no ruptures were
observed in these patients
Lal JVS 2015
DREAM and EVAR 1 –
Multicenter RCTs from Europe
• DREAM
– 171 EVAR procedures done
– Mean follow up 6.4 years (range 5.1-8.2)
– 6 (4%) treated for T2EL
– No ruptures
• EVAR 1
– 624 EVAR procedures
– Follow up to 8 years
– 91 (15%) with T2EL
– 17 (3%) had T2EL with sac expansion
De Bruin NEJM 2010
EVAR 1 NEJM 2010
Well what about the real world experience
outside regulated studies?
Kaiser Experience
• 1736 EVAR procedures done within Kaiser Northern
California between 2000 – 2010
• Mean f/u 32 months
• 27.3% with T2EL
• No ruptures attributable to T2EL
• 17% of those with T2EL and sac expansion were
subsequently found to have another type of EL
• Only 37% of interventions were successful at stopping
T2EL
• Presence of T2EL not associated with change in survival
overall or among those with/without sac growth
Walker JVS 2015
Kaiser Experience
Walker JVS 2015
Kaiser Experience
Confirmation of the validity of the Kaiser dataset:
The survival curves for those with and without T2EL are identical
to the overall Medicare cohort of 40,000 patients reported by
Schermerhorn et al. with mean survival of 7 years Walker JVS 2015
Schermerhorn NEJM 2015
Italian Experience
•
•
•
•
•
1412 consecutive EVAR cases done 1997-2011
Median f/u 45 months
15% incidence of T2EL
T2EL associated with increased risk of sac expansion
Re-interventions performed for 7%, including 17 open
conversions
• No difference in presence of T2EL in those who were
or were not treated – treatment was not effective
• T2EL had no impact on late aneurysm related survival
at 60 months
Cieri JVS 2014
Many datasets describe T2EL incidence and sequelae
1. Incidence of about 20-30%
2. Frequently a cause of secondary intervention
3. Rarely a cause of aneurysm related mortality
Unfortunately, all of these datasets suffer the same
limitation, which is a lack of standardization about when
and how T2ELs are treated
So we don’t really know what the true clinical impact is
of these findings
What about treatment for T2EL?
Treatment for T2EL
• Kaiser: Only 37% of interventions were successful at fully
excluding T2EL
• Italian Series: Intervention was not effective at reducing the
overall prevalence of T2EL
• Cleveland Clinic Series:
• 95 patients treated for T2EL 2000-2008
• 140 procedures performed, including 9 explantations
• Only 44% had freedom from sac growth at 5 years after
treatment
• No deaths due to rupture
• 8.6% procedure related complications, including: MI, 2
mesenteric ischemia, renal perforation, severe
claudication, pseudo-aneurysm, aspiration, and others
Sarak JVS 2012
What does T2EL tell us about the patient?
T2EL and Inflammation
• Study of 79 Veterans treated with EVAR compared those
with and without co-morbid systemic inflammatory disease
(SID) (auto-immune, auto-inflammatory, e.g. eczema,
rheumatoid arthritis)
• Any sort of SID was seen in 65% of the cohort
• Mean f/u of 5 years
• T2EL seen in 33% of those with SID vs. 7% of those without
• OR 2.5 that EL in patients with SID was associated with sac
expansion
• Again, however, no difference in overall survival
• So perhaps systemic inflammation is a factor in the natural
history of T2 EL
Shelby JAMASurg 2016
Effect of Statins
• Retrospective comparison of patients with immediate
post-op T2EL treated with statins or not
• 85 (11%) of 756 EVAR patients with early T2EL
• 32 (37%) on statins at time of discharge
• At 36 months: 11% vs 64% had persistent T2EL
• Multi-variate regression modeling showed:
• HR 0.40 (0.20-0.81) p=0.01
• No effect of anticoagulation, IMA, # of patent
lumbar arteries, or aneurysm size
• So again, perhaps systemic inflammation is a primary
(or significant) driver of T2EL behavior
Pini AnnVascSurg 2015
Outcome of the case example
Type 2 EL after t-Branch
• July 2016: almost 4 years post-operation, the
patient passed away due to a rapidly
progressive neurodegenerative disorder
• Imaging done prior to his death showed the
aneurysm had expanded to 9.5 cm
• Did the intervention help?
• How dangerous was this multi-focal
intercostal/lumbar type 2 endoleak?
Easy Conclusions
• T2EL occur in 20-30% of EVAR cases
• Improved imaging does not seem to be the cause of
increased T2EL detection, as the rate seems stable over
the last 15 years
• Re-interventions have been performed for T2EL in 38% of patients undergoing EVAR
• These interventions are frequently ineffective
• Treatment for T2EL is not without risk
• Aneurysm rupture due to T2EL is exceedingly rare
• All studies are retrospective and do not control for
physician decision to treat the T2EL or method of
treatment
Less Clear Conclusions
• T2EL may be caused or exacerbated by ongoing systemic
inflammation
• It’s possible that T2EL are more a factor of the patient’s
biology than the device and/or the aortic anatomy
• Treatment for T2EL should be tailored to the individual
based on aneurysm size, morbidity of treatment, and the
patient’s overall prognosis
• Many T2EL, even those associated with slight sac
enlargement may not require re-intervention