Abdominal and thoracic aneurysm repair - summitMD.com

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Abdominal and thoracic aneurysm repair - summitMD.com

Abdominal and thoracic

aneurysm repair

William A. Gray MD

Director, Endovascular Intervention

Cardiovascular Research Foundation

Columbia University Medical Center


Abdominal Aortic Aneurysm Endografts


AAA is under diagnosed and under treated

Prevalence of AAA in the U.S. Versus Diagnosis

• The prevalence of

AAA in men is

4.5% and in

women is 1.0%

(data from SAVE

screenings)

• 1,152,294 patients

living with AAA

Prevalence = 1,152,294

Diagnosed = 172,900

Total Treated = 69,300

Treated w/ EVAR = 22,300

• 15% are diagnosed

• 6% are treated


Abdominal Aortic Aneurysm

Diameter

< 4 cm

4 - 5 cm

5 - 6 cm

6 - 7 cm

7 - 8 cm

> 8 cm

Annual Risk

of Rupture

0 %

0.5 - 5 %

3 - 15 %

10 - 20 %

20 - 40 %

30 - 50 %

J Vasc Surg 2003;37:1106-17


Threshold to intervention

• Prophylactic treatment decisions can be difficult

(asymptomatic patients)

• Major considerations are operative mortality and life

expectancy compared to risk of rupture

• In general, AAA’s s 5.0-5.5

5.5 cms in reasonable risk

patients should be repaired

• AAA’s s exceeding the expected rate of growth of 10%

per year warrant repair

• EVAR may lower the threshold to treat


Elective open repair AAA

• Major surgical procedure

− Mortality 2% to 5%

• Complications

− Pseudoaneurysms

− Erectile dysfunction

− Aortoenteric fistula

− Graft thrombosis

− Graft infection

• Recovery period 6 weeks to 4 months


Functional Outcomes Following Open AAA Repair

• 154 consecutive elective AAA repairs

• 1990-1997

1997

• Operative mortality 4%

• Mean hospital stay 10.7 days

• Mean ICU stay 4.57 days

• 11% of pts transferred to skilled nursing facility

− Mean stay 3.66 months

• Only 64% of patients experienced complete recovery

− Mean time 3.9 mos

• 33% were not fully recovered at mean f/u of 34 mos

• 18% said they would not undergo AAA repair again

knowing recovery process

Oregon Health Sciences Center

J Vasc Surg 2001;33:913-20


Endovascular Repair

• Proven benefits

• Minimally invasive

• Reduced morbidity

• Reduced hospital stay

• Early return to function

• Typically 2 to 4 weeks for full recovery


Currently Available Devices (U.S.)

Medtronic

AneuRx

US Trial Implants 1193

Gore

Excluder

US Trial Implants 235

Cook

Zenith

US Trial Implants 352

Endologix

Powerlink

US Trial Implants 192


Device profiles

Device profiles

woven

woven

polyester

polyester

infrarenal

infrarenal

21F

21F

20,22,24,

20,22,24,

26,28

26,28

aneuRx

aneuRx

medtronic

medtronic

ePTFE

ePTFE

infrarenal

infrarenal

18F

18F

23,26,

23,26,

28.5

28.5

excluder

excluder

gore and

gore and

associates

associates

ePTFE

ePTFE

infrarenal

infrarenal

21F,22F

21F,22F

25,28

25,28

power

powerlink

link

endologix

endologix

woven

woven

polyester

polyester

suprarenal

suprarenal

20F,23F

20F,23F

22,24,26,

22,24,26,

28,30,32

28,30,32

zenith

zenith

cook

cook

graft

graft

material

material

fixation

fixation

location

location

outer

outer

diameter

diameter

neck

neck

diameter

diameter

device

device

company

company


Anatomic considerations/limitations

Endovascular Stent Grafts

• Proximal aortic neck

• Diameter of device oversized 10-20%

• Length ≥ 1.5cm for all FDA approved devices

• Angulation/tortuosity

• Short angulated necks, short wide necks, & severe AAA

tortuosity can lead to suboptimal outcomes

• Iliac access

• Large enough to accommodate 18F-24F delivery

systems (7-8mm for bifurcated devices)


Preoperative Imaging

CTA (3mm cuts)

Infrarenal

neck

Aneurysm

with

thrombus

Iliac

access


Iliac aneurysms


INTRAOPERATIVE ANGIOGRAM


• Completion angiogram (


Endoleaks


Follow-Up Imaging

CTA to assess endoleak and size

• 1 month

• 6 months

• 12 months

• Annually

Graft separation


Alternatives to CT scanning

• Ultrasound with or without contrast agent

• Cardiomems device to assess endotension

• May be more sensitive than other methods

• Allows for direct measurement of pressure within

the excluded sac

• Need data to support endotension as a predictor

of delayed rupture

• Requires specialized monitoring equipment


Outcomes with EVAR: Lifeline Registry

Freedom from aneurysm-related related issues

• 2664 EVAR vs. 334 open repairs

• K-M M analysis at 6 years:

• 99% freedom from rupture

• 98% freedom from aneurysm-related related death

• 95% freedom from surgical conversion


As aneurysms grow in size, proximal

necks can become shorter and more

angulated which may preclude patient

from being good anatomic candidate

for stent graft


Small vs. large AAA

2 year clinical outcomes following EVAR

Type 1 Endoleak

Migration

Conversion

Aneurysm Related

Death

Survival @ 24 months

Small

< 5.5 cm

1.4 %

4.4 %

1.4 %

1.5 %

86 %

Large

> 5.5 cm

6.4 %

13 %

8.2 %

6.1 %

71 %

Ouriel et al

J Vasc Surg 2003;37:1206-12


PIVOTAL Trial

• Positive Impact of endovascular options for treating

aneurysms

• Randomization of close to 1700 patients with 4-5cm 4

AAA’s s to EVAR or continued follow up

• AAA’s s must exceed double the diameter of the

reference aorta and meet inclusion criteria for the

AneuRX device

• Patients who become symptomatic, exceed 5.0 cms

or experience rapid growth will be offered repair


Improvements in Cath Lab imaging

DynaCT acquisition


Extending applicability: Cook fenestrated


Extending applicability: branch grafts

Common Iliac Aneurysm


Thoracic endograft (TEVAR)


Thoracic aortic aneurysm: size vs. rupture

Yearly risk

> 3.5cm

>4.0cm

>5.0 cm

> 6.0cm

Rupture

0.0%

0.3%

1.7%

3.6%

Dissection

2.2%

1.5%

2.5%

3.7%

Death

5.9%

4.6%

4.8%

10.8%

Any of the above

7.2%

5.3%

6.5%

14.1%


Gore thoracic endograft: : pivotal trial

• 140 TAG vs. historical/concurrent surgical control

of 94

• Safety endpoint: 1 year MAE (non-inferiority)

– Death, repeat hospitalization, permanent sequelae, repeat

procedure/surgery

• Efficacy endpoint: 1 year freedom from device-event

event

(superiority)

• At 2 years, TAG resulted in

• less LOS/ICU use,

• lower paraplegia (3% vs. 14%)

• lower CVA (5% vs. 10%)

• fewer re-op (4% vs. 10%)

• less aneurysm-related related death (97% vs. 90%)

• No difference in all-cause mortality (26% vs. 28%)


Completing the “Elephant trunk” repair for

arch aneurysm or dissection


Completing the “Elephant trunk” repair for

arch aneurysm or dissection

Surgical clips on graft


Completing the “Elephant trunk” repair for

arch aneurysm or dissection

First segment


Completing the “Elephant trunk” repair for

arch aneurysm or dissection

Final segment


Completing the “Elephant trunk” repair for

arch aneurysm or dissection


Completing the “Elephant trunk” repair for

arch aneurysm or dissection

“Preclose”


TEVAR considerations: Paraplegia

• Coverage of graft from zones 2-72

usually does not result in paralysis

• Coverage from zones 8-128

may be

associated with higher risk of

paraplegia

• Precedent AAA surgery increased

risk

• To address risk of paraplegia:

• Spinal drainage

• Maintain adequate blood pressure

01 02 03

04

05

06

07

08

09

10

11

12


TEVAR Considerations: covering subclavian

• If covering the subclavian to mitigate a short neck is

considered, ask:

• Is there a LIMA bypass?

• Is dominant vertebral flow derived from the

subclavian?

• Does carotid stenosis present a risk factor?

• Obtain a full carotid angiogram to assess

carotid flow

• Be prepared to do subclavian bypass if indicated


TEVAR considerations: Angulation

65 degrees


Extending TEVAR: Penetrating ulcer


Extending TEVAR: Thoracic dissection

• Type A: Surgical repair

• Type B:

• Surgery for type B aortic dissection

• 14% to 67% risk of irreversible spinal cord injury or

postoperative mortality

• Medical management for uncomplicated dissection with

aggressive antihypertensive therapy

• ~85% of patients survive initial hospital stay

• Long-term outcome is unsatisfactory

• ~25% late expansion of the false lumen at 4 years

• formation of a thoracic aneurysm with inherent risk of

rupture or to retrograde progression of dissection with

involvement of the proximal aorta with even higher

mortality

• 50% mortality at 5 years


Endografting for dissection: INSTEAD trial

• European trial

• Patients with uncomplicated Type B dissection

• Randomized to medical or endo Rx

• Endpoint: all cause mortality at 2 years

• Preliminary outcomes at 1 year: no difference

in mortality


Evolution of Endovascular Indications

Thoracic

Branch

Standard AAA

Fenestrated

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