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Management of Vascular Disease
Weighing Natural History Against
Outcomes after Interventions
Scott Berceli, MD PhD
Associate Professor of Surgery
CarotidStenosis
Carotid Endarterectomy
100%
AorticAneurysm
Open AAARepair100%
LegIschemia
Lower ExtremityBypass100%
Disease:
Treatment:
Standard Vascular Surgical Practice(circa. 2000)
CarotidStenosis
Carotid Endarterectomy
60%+
Carotid Stenting40%
AorticAneurysm
Open AAARepair20%
+Endograft AAA
Repair80%
LegIschemia
Lower ExtremityBypass
80%+
SFA StentingTibial Angioplasty
20%
Disease:
Treatment:
Standard Vascular Surgical Practice(circa. 2007)
Abdominal Aortic Aneurysms
Incidence • Found in 2-5% of individuals > 65 year old • Accounts for 1.2% of deaths in > 65 age group• 13th leading cause of death in U.S.
Risk Factors • Hypertension• Smoking• Family History (20% first degree relatives) • Male sex (4:1 M:F ratio)• Advancing age (rare in patients < 50 y.o.)
Rupture Risk
1960’s to 1990’s
2%
5%
10%
20%
0%
5%
10%
15%
20%
3.0 4.0 5.0 6.0 7.0 8.0
Size (cm)
Year
ly ri
sk o
f AA
A ru
ptur
e
Adapted from Szilagyi, Ann Surg, 1966
2004
ADAMs TrialUK Small Aneurysm
Patients with 4.0 to 5.5 cm AAA randomized to repair or observation
• no difference in AAA related mortality• 5.0-5.5 cm rupture risk 2% per year
]
VA Large AneurysmLongitudinal study of high risk patients with > 6.0 AAA
• 5.5 - 5.9 cm 9.2% per year• 6.0 - 6.4 cm 10.5 % per year• 6.5 - 6.9 cm 19.1% per year• > 7.0 cm 32.5% per year
]Determined from abd films
and physical exam
0%
5%
10%
15%
20%
3.0 4.0 5.0 6.0 7.0 8.0
Size (cm)
Year
ly ri
sk o
f AAA
rupt
ure
Revised
Previous
Timing of elective AAA Repair
• Repair vs. continued observation offered for AAA 5.0-5.5 cm• Repair recommended for AAA 5.5 cm (good risk patients)
+Operative Mortality
(open and endovascular) 2-4%
=
Presentation of Patients with Ruptured AAA
Classic Triad• Abdominal or back pain• Pulsatile abdominal mass• Hypotension
• 95% of all patients with rupture have at least 1 of 3 signs
• < 50% of patient with rupture have all 3 signs
Treatment is immediate operative repair within minutes
Symptomatic AAA
• Acute presentation of back or abdominal pain in a patient with a AAA (4.0 cm or greater) without other identifiable etiology
• Often accompanied by a tender aneurysm on exam
• Hemodynamically stable, with no evidence of rupture on CT scan
• Natural history his poorly known, felt to represent impending rupture (hours to day to weeks?)
• Warrants emergent vascular surgery evaluation, usually leading to urgent operative repair within hours
Symptomatic AAA = Ruptured AAA
Methods of AAA Repair
• Open• Endovascular
Open operative repair
Endovascular repair
• Material Components– Graft: woven polyester– Stent: nitinol (nickel-titanium)
exoskeleton• Thermal shape memory
– Non-absorbable polyester sutures• >2000 hand-sewn suture/stent graft
Primary Bifurcated Module Delivery Catheter
Infrarenal Placement
Completed Primary Deployment
Contralateral Limb Delivery Catheter Access
Contralateral Limb Deployment
Completed Repair
Carotid Artery Stenosis
Pathophysiology
50% or less due to disease of the carotid bifurcation
Risk Factors
• TIA’s
• Hypertension
• Cigarette smoking
• Hyperlipidemia
• Age, male sex, race, heredity
• Diabetes
History of carotid endarterectomy in the U.S.
Design a clinical trial
NASCETDesign
3000 patients randomized to medical or surgical therapy and followed for a minimum of 5 years
50 selected centers (<6% peri op stroke/death rate), sxs within 3 months, <80 yo; specific angio criteria
NASCET
2 year estimate by life table of ipsilateral stroke 26% for medical, 9% for surgical (70-99%)
18 mo mortality risk reduction 58%, stroke risk reduction 71%
NASCET
2 yr Estimate of Ipsilateral Stroke
Failure Rate NNT
Stenosis Medical Surgical
70-99% 26.1% 12.9% 8
50-69% 22.2% 15.7% 15
<50% 18.7% 14.9% 26
ACAS
• 39 centers, 17 credentialed surgeons (<3% for asymptomatic)
• <80 yo
• 1662 patients with >60% stenosis by angio
ACAS
Operative and angio stroke morbidity/mortality 2.3% (1.2% angio)
Surgery No Surgery
Projected 5 yr 5.1% 11%
stroke event rate
Stroke risk reduction 55% (only 17% for females)
ACAS
• Stroke risk reduces from 2%/yr to 1%/yr, or 5% at 5 yrs
• One stroke prevented for every 20 CEAs done in asymptomatic patients