Matthew J. Eagleton, MD Associate Professor Walter W ...Matthew J. Eagleton, MD Associate Professor Walter W. Buckley Endowed Chair in Research Cleveland Clinic Lerner College of Medicine-CWRU

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 Freedom from Aneurysm-RelatedMortality: 98%Mortality: 98%


~65% at 5 years

Secondary ProceduresSecondary ProceduresBranch Occlusions

Stent MigrationStent MigrationEndoleak

Aneurysm GrowthAneurysm GrowthSpinal Cord Ischemia


• 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%


•• 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


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


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


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



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


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%


• 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


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%)


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


36-Month Values:Overall: 57%Overall: 57%Type II: 46%

Type III: 62%

36-Month Freedom fromAneurysm-Related Mortality is 91%

p=0.01


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



(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



• 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


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


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%


• 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)


Documents

Matthew J. Eagleton, MD Associate Professor Walter W ...Matthew J. Eagleton, MD Associate Professor Walter W. Buckley Endowed Chair in Research Cleveland Clinic Lerner College of Medicine-CWRU