Matthew J. Eagleton, MDMatthew J. Eagleton, MDAssociate Professor
Walter W. Buckley Endowed Chair in ResearchCleveland Clinic Lerner College of Medicine-CWRU
Houston Aortic Symposium 2017
• Aortica: Advisory Board• Aortica: Advisory Board
• Centerline Biomedical: Advisory Board
FEVAR l February 25, 2017 l 2
• Roy Greenberg, MD – initiated IDE trial 2001• Roy Greenberg, MD – initiated IDE trial 2001
IDE Enrollment 2001-2016:1257 Patients1257 PatientsIncreasing Complexity
JRAAType IV
Type I
Type II
Type III
Aortic Aneurysms treated with
F/B-EVAR:F/B-EVAR:
PS-IDE, CMD: High Risk Patients
JRAA and Type I, II, IIIJRAA and
Type IV TAAA
2001
Type I, II, III
TAAA
20042001 2004
• Single center, prospective study: 2001-2013
• 610 patients
–258 Juxtarenal–258 Juxtarenal
–349 Type IV TAAA
• Fenestrations and scallops – varying degrees• Fenestrations and scallops – varying degreesof coverage (Renals, SMA, Celiac)
• Mean FU: 8 years• Mean FU: 8 years
Mastracci TM, Eagleton MJ et al; J Vasc Surg 2015; 61: 355-64
5-Year Survival: 50%
8-Year Survival: 20%
5-Year Survival: 50%
8-Year Survival: 20%
8-Year Freedom from Aneurysm-RelatedMortality: 98%Mortality: 98%
Mastracci TM, Eagleton MJ et al; J Vasc Surg 2015; 61: 355-64
~65% at 5 years
Secondary ProceduresSecondary ProceduresBranch Occlusions
Stent MigrationStent MigrationEndoleak
Aneurysm GrowthAneurysm GrowthSpinal Cord Ischemia
Mastracci TM, Eagleton MJ et al; J Vasc Surg 2015; 61: 355-64
• 2o Procedures (Vascular/Aortic): 26.4%• 2 Procedures (Vascular/Aortic): 26.4%
• Spinal Cord Ischemia: 1.16%
–Mean coverage above celiac w/ SCI: 52 ± 21 mm–Mean coverage above celiac w/ SCI: 52 ± 21 mm
–Mean coverage above celiac w/o SCI: 33 ± 21 mm
• Stent Fracture: 2.2%• Stent Fracture: 2.2%
• Stent Migration: 0.16%
Mastracci TM, Eagleton MJ et al; J Vasc Surg 2015; 61: 355-64
•• 30 (1.9%) branch occlusions
–1/109 (1%) celiac stents
–3/333 (1%) SMA stents–3/333 (1%) SMA stents
–12/558 (2.2%) left renal artery stents
–12/553 (2.2%) right renal artery stents–12/553 (2.2%) right renal artery stents
Mastracci TM, J Vasc Surg 2013; 57: 926-33
• SMA: 26 (4%)• SMA: 26 (4%)
–13 endoleak
–13 stenosis/thrombosis–13 stenosis/thrombosis
• Renals: 58 (5%)• Renals: 58 (5%)
–28 endoleak
–30 stenosis/thrombosis–30 stenosis/thrombosis
Mastracci TM, J Vasc Surg 2013; 57: 926-33
1.0
30-Day: 98% (96-99%)0
.8
Fre
ed
om
fro
mse
con
da
ryin
terv
en
tion
s 30-Day: 98% (96-99%)
1-Yr: 94% (92-96%)
0.4
0.6
Fre
ed
om
fro
mse
con
da
ryin
terv
en
tion
s
5-Yr: 89% (78-90%)
1-Yr: 94% (92-96%)
0.2
0.4
Fre
ed
om
fro
mse
con
da
ryin
terv
en
tion
s
5-Yr: 89% (78-90%)
No factor showed association w/ increased0 2 4 6 8
0.0
Years of follow up
No factor showed association w/ increasedrisk for re-intervention
Years of follow up
Mastracci TM, J Vasc Surg 2013; 57: 926-33
Total Supra-celiac
CeliacScallop
SMA orlower
Renal orlowerceliac Scallop lower lower
Endoleak- Type 1- Type 3
3%4.6%
3.4%10%
1.1%5.2%
2.1%2.7%
10.4%9.3%
AneurysmGrowth
3.6% 5.2% 2.1% 4.6% 2.6%
AneurysmRupture
2.3% 5.2% 1.1% 2.8% 1.3%
More complex grafts – More endoleak potentialMore complex grafts – More endoleak potential
Less extensive grafts – More endoleak potential
Mastracci TM, Eagleton MJ et al; J Vasc Surg 2015; 61: 355-64
Higher Rates:Higher Rates:- Most type 1 leaks occurred late- Most occurred from patients early in our- Most occurred from patients early in our
experience- Landing zone- Landing zone
- Shorter- Involved fewer visceral vessels- Involved fewer visceral vessels
O’Callaghan A, et al; J Vasc Surg 2015; 61: 908-14
20112008 2011
2005
Courtesy T. Mastracci
O’Callaghan A, et al; J Vasc Surg 2015; 61: 908-14
O’Callaghan A, et al; J Vasc Surg 2015; 61: 908-14
354 TYPE II AND III TAAA
REPAIRSREPAIRS
Eagleton, et al; J Vasc Surg 2016; 63: 930-42
Device Configuration: 1320 Target Vessels
274 Patients(77.4%)(77.4%)
Fenestrations Only
45 Patients(12.7%)(12.7%)
Single Branch with Fenestrations
35 Patients(9.9%)
Double Branches with FenestrationsDouble Branches with Fenestrations
Eagleton, et al; J Vasc Surg 2016; 63: 930-42
Overall technical success rate: 91.2%
Branch-specific technical success rates:
Celiac SMA Right Renal Left RenalCeliac SMA Right Renal Left Renal
96.3% 100% 99% 99%
30-Day/In-Hospital Mortality: 4.8%30-Day/In-Hospital Mortality: 4.8%
Eagleton, et al; J Vasc Surg 2016; 63: 930-42
• Renal Failure: 2.8%
–Type II: 5.5%*–Type II: 5.5%
–Type III: 1.3%
• Spinal Cord Ischemia (Permanent): 4%
––Type II: 7.8%*
–Type III: 1.8%
–Adjuncts to reduce – last 3 years for type II < 4%
* P<0.0.5* P<0.0.5
Eagleton, et al; J Vasc Surg 2016; 63: 930-42
Endoleak 67 (18.9%)Endoleak 67 (18.9%)
Branch Occlusion or Stenosis 27 (7.6%)
Aortic-Related Re-interventions 9 (2.5%)Aortic-Related Re-interventions 9 (2.5%)
Component Separation (withoutendoleak)
5 (1.4%)
Access Site Pseudoaneurysm 4 (1.1%)Access Site Pseudoaneurysm 4 (1.1%)
Chronic Lower Extremity Ischemia 3 (0.8%)
Iliac Aneurysm Expansion 1 (0.2%)Iliac Aneurysm Expansion 1 (0.2%)
Eagleton, et al; J Vasc Surg 2016; 63: 930-42
SMA
0.8
1.0
0.8
1.0Celiac SMA
Celia
cP
ate
ncy
Rate
s
0.4
0.6
SM
AP
ate
ncy
Rate
s
0.4
0.6
Months
0 12 24 36 48 60
0.0
0.2
Months
0 12 24 36 48 60
0.0
0.2
Left Renal Right Renal
Left
RenalP
ate
ncy
Rate
s
0.6
0.8
1.0
Left Renal
Rig
htR
enalP
ate
ncy
Rate
s
0.6
0.8
1.0
Left
RenalP
ate
ncy
Rate
s
0.0
0.2
0.4
Rig
htR
enalP
ate
ncy
Rate
s
0.0
0.2
0.4
Primary PatencySecondary Patency
Months
0 12 24 36 48 60
0.0
Months
0 12 24 36 48 60
0.0
Eagleton, et al; J Vasc Surg 2016; 63: 930-42
36-Month Values:Overall: 57%Overall: 57%Type II: 46%
Type III: 62%
36-Month Freedom fromAneurysm-Related Mortality is 91%
p=0.01
Eagleton, et al; J Vasc Surg 2016; 63: 930-42
Concern for high long-term mortality rates in our series.
2001-2015: 1091 patients from the IDE
522 patients died after F/B-EVAR
Mean follow-up: 2.8± 2.4 yrs (median 2.3 yrs)
3084 patient-years available for analysis3084 patient-years available for analysis
Beach et al., SAVS January 2017
100
80
100
US Life Matched
60
80Survival:
30-day: 97%1-year: 93%
40
1-year: 93%2-year: 75%3-year: 64%5-year 46%7-year: 30%
20 High-risk, untreated
7-year: 30%
00 1 2 3 4 5 6 7
YearsYearsBeach et al., SAVS January 2017
50
40
50
Early Phase (0-4 mos)
30
40Constant Phase
Late Phase (> 4 mos)
20
30Late Phase (> 4 mos)
10
00 1 2 3 4 5 6 7
Years0 1 2 3 4 5 6 7
YearsBeach et al., SAVS January 2017
Risk Factors for Death:
• Type I/II or III repair•
• Lower Systolic Blood Pressure (preoperative)
• Higher BUN*• Higher BUN*
• Smaller renal artery diameter
• No preop antiplatelet use• No preop antiplatelet use
• Thrombocytopenia (preoperative)
* Not on dialy sis* Not on dialy sis
Beach et al., SAVS January 2017
Risk Factors for Death:
(entire post-op period)(entire post-op period)
• Larger maximum aortic diameter• Larger maximum aortic diameter
• Lower BSA
• COPD• COPD
• Higher heart rate
• Lower Ejection Fraction• Lower Ejection Fraction
• Lower hemoglobin (preoperative)
•• More severe renal artery disease
Beach et al., SAVS January 2017
Risk Factors for Death:
• Type I/II TAAA repair
• Older Age
• Higher weight (BMI)• Higher weight (BMI)
• Congestive Heart Failure
• No preop antiplatelet use• No preop antiplatelet use
• Longer prothrombin time
Beach et al., SAVS January 2017
Increased Risk Death at 2-Years
• Congestive heart failure• Congestive heart failure
• COPD
• Renal dysfunction• Renal dysfunction
• Anemia
• Coagulation disorders
• Type I/II repair and larger aneurysms
Beach et al., SAVS January 2017
Clinical Scenario
• Case 1: 65yo M, no CHF, COPD, or renal• Case 1: 65yo M, no CHF, COPD, or renaldisease, normal blood counts, onantiplatelet, type IV repairantiplatelet, type IV repair
• Case 2: 75yo M, with CHF, COPD, andmild anemia and thrombocytopenia, mildmild anemia and thrombocytopenia, mildrenal dysfunction, type I/II repair
Predicted 2 year survivalPredicted 2 year survival
76.5% vs 29.3%76.5% vs 29.3%
Beach et al., SAVS January 2017
• Data represents an evolution in devices andtechniquestechniques
• F/B-EVAR is a good alternative for patients withaortic aneurysms – but will require reinterventionaortic aneurysms – but will require reintervention
• Keys to success:
–Routine monitoring and early re-intervention for–Routine monitoring and early re-intervention forstenosis and endoleaks
–Careful selection of proximal and distal aortic–Careful selection of proximal and distal aorticlanding zones
• Outcomes will continue to improve with
–Experienced providers refining its application–Experienced providers refining its application
–Improvements in technology
–Attention to patient medical care – affect–Attention to patient medical care – affectlong-term survival
Survival: Open v. F/B-EVAR(estimates)
-------- Simulated OR-------- CCF F/B-EVAR
Su
rviv
al
Su
rviv
al
Su
rviv
al
Su
rviv
al
Time (months)
Survival: Open v. F/B-EVAR(estimates)
-------- Simulated OR-------- CCF F/B-EVAR
Su
rviv
al
Time (months)Time (months)
Mastracci TM, Eagleton MJ et al; J Vasc Surg 2015; 61: 355-64