s ean p . l yd en, m d, fa c s · medtronic, bard, gore, bolton medical, endologix • 3-4/100,000...

S ean P . L yd en, M D , FA C SS ean P . L yd en, M D , FA C SP rofessor& C hairm anP rofessor& C hairm an

D epartm entofVasc u larS u rgeryD epartm entofVasc u larS u rgery

C leveland C linic Fou nd ationC leveland C linic Fou nd ationC leveland C linic Fou nd ationC leveland C linic Fou nd ation

H ou stonA ortic Symposiu m 2017

• Consultant: Endologix, Biomet, TVA MedicalPQ Bypass, Spectranetics

• VIVA Physicians, Board Member

• CMO: Excelerate Strategic Health Sourcing

• Research Studies: Cook, Trivascular,Medtronic, Bard, Gore, Bolton Medical,EndologixEndologix

• 3-4/100,000 person years annually

• Ratio 5:1 type A to B• Ratio 5:1 type A to B

• Calculated incidence type B• 0.5/100,000• 0.5/100,000

• International Registry of Aortic Dissection

• Started in 1996• Started in 1996

• 30 referral centers in 11 countries

• Main purpose is to assess the etiological• Main purpose is to assess the etiologicalfactors, modes of presentation, clinicalfeatures, treatment, and hospital outcomes ofpatients with acute aortic dissection aroundpatients with acute aortic dissection aroundthe world

• Acute• Symptoms ≤ 14 days

• Based on fact that most died w/in 14 days• Based on fact that most died w/in 14 days

• Chronic• >14 days• >14 days

• Suggested New Classification• Acute aortic dissections include the first 3 months

• Sub-acute symptoms persist from 3 through 12 months• Sub-acute symptoms persist from 3 through 12 months

• Chronic aortic dissections have symptoms persist for >1 year

• Medical treatment

• Standard of care both Complicated andUncomplicatedUncomplicated

• Repair for Complicated Type B AD accepted

• Uncomplicated Type B AD• Uncomplicated Type B AD

• What are the outcomes?

• IRAD 2006- 72%

• Nienaber 2005- 73%• Nienaber 2005- 73%

• Estrera 2006- 82%

• Umana 2002- 85%• Umana 2002- 85%

• Winnerkvist 2006- 90%

• Late problems up to 30%

• Death, aneurysm formation, rupture• Death, aneurysm formation, rupture

• 1980-1995

• 225 pts• 16.8% Open Rx of descending aorta w/in 1st week

• 187 primary conservative Rx• 17.6% Hospital mortality w initial conservative treatment• 17.6% Hospital mortality w initial conservative treatment

• Actuarial survival rates after conservative Rx• 5 year 76 +/- 5%

• 8 year 50 +/- 7%

Schweiz Med Wochenschr. 1997 Sep 6;127(36):1467-73

• 242 pts Acute B AD

• In IRAD 96-03

• Independent predictors offollow-up mortality• Female gender

• In IRAD 96-03

• Kaplan-Meier survival

• 3 yr survival

• Female gender

• Hx prior aortic aneurysm

• Hx of atheroclerosis• 3 yr survival• Medical Rx 77.6 ±6.6%

• Surgical Rx 82.8 ±18.9%

• Endovascular 76 ±25.2%

• In-hospital renal failure

• Pleural effusion on chestradiograph

• Endovascular 76 ±25.2%• In-hospital

hypotension/shock

Circulation 2006 Nov 21; 114(21):2226-3

• Access related

• Iliac artery dissection or rupture

• Embolization

• Arch related

• Stroke

• Retrograde type A

• Disease Related• Disease Related

• False lumen flow and growth

• Seal failures• Seal failures

• Paralysis or paraparesis

• TEVAR for IMHType B AD via Rfemoral accessfemoral access

• 6 Hours later LLEischemiaischemia

• Emboli of intima tocontralateral legcontralateral leg

63 cases 60% Talent 60% SINE63 cases

(1.33%)

60% Talent

19% Valiant

13% TAG

2% TX2

60% SINE

83% Proximal barespring

2% TX2

C ircu lation.2009 Sep15;120(11 Su ppl):S27 6-8 1

• Retrograde aortic dissection

• Incidence between 6.8% and 8.5% in patients treatedwith TEVARwith TEVAR

• MOTHER Registry:• 4.3% for acute aortic dissection• 4.3% for acute aortic dissection

• 3% for chronic dissection

• 0.7% for patients with TAA

JThorac C ard iovasc Su rg2015;149:S151-6A nn Su rg2014;260:38 9-95

P u blic ation O verallRTA D D evic es S INE Inc id enc eP u blic ation O verallRTA D D evic es

Used

S INE Inc id enc e

Dong 2010 27 cases 52% Talent* 1.8% Talent

(4.2%)

23 cases SINE

(3.4% SINE)

35% Valiant*

9% TX2*

4%Hercules*

1.2% Valiant

0.3% TX2

0.15% HerculesHercules*

JV asc Su rg.2010 D ec;52(6):1450-7

P riorA B IThoracic Gore Stentfor

d issection

L renalbypass

d issection

End of thoracicP riorinfrarenalgraft

celiac bypasssmabypass

End of thoracicstentgraftC an clampstentGraftsGrafts

R renalbypass

• Complications 10%

• Stroke

• Occlusion• Occlusion

• Horners

• Thoracic duct leakage• Thoracic duct leakage

• Chylothorax

• Hemorrhage• Hemorrhage

• Infection

• Nerve injury• Nerve injury

JC ard iothorac Su rg.2014;9:165,V ascu lar.2017 Feb;25(1):7 4-7 9,JV asc Su rg1998 ;27 :1148 -51

• 40 patients Complicated Type B

• 30 day mortality 5%, 2 more in-hospital deaths• 30 day mortality 5%, 2 more in-hospital deaths

• Morbidity

• Stroke 7.5%

• TIA 2.5%

• Paraplegia 2.5%

• Retrograde dissection 5%• Retrograde dissection 5%

• Renal failure 12.5%

JV asc Su rg.2012 M ar;55(3):629-640

• 140 pts chronic type B medical mgmt 68 vsTEVAR 72 patients

• Outcomes aorta-specific, all-cause outcomes, anddisease progression using landmark statisticalanalysis of years 2 to 5 after index procedureanalysis of years 2 to 5 after index procedure• 5 year all-cause mortality (11.1% versus 19.3%; P=0.13),

• 5 year aorta-specific mortality (6.9% versus 19.3%; P=0.04),• 5 year aorta-specific mortality (6.9% versus 19.3%; P=0.04),

• 5 year progression (27.0% versus 46.1%; P=0.04)

Circ Cardiovasc Interv. 2013 Aug;6(4):407-16

• Benefit of TEVAR between 2-5 years

• Both improved survival and less progression• Both improved survival and less progressionof disease at 5 years after elective TEVARwere associated with stent graft induced falselumen thrombosis in 90.6% of caseslumen thrombosis in 90.6% of cases(P<0.0001).

Circ Cardiovasc Interv. 2013 Aug;6(4):407-16

• Chronic uncomplicated TBAD (n =72)

• 1 Rupture of access vessel

• 1 Abdominal redissection with intestinalmalperfusion

• 1 Type A dissection with pericardial tamponade• 1 Type A dissection with pericardial tamponade

• 2 Sudden cardiac death• 1 Vfib, 1 PE• 1 Vfib, 1 PE

• Neurological adverse events

• 1 paraplegia, 1 transient paraparesis & 1 fatal stroke• 1 paraplegia, 1 transient paraparesis & 1 fatal stroke

C ircu lation.2009;120:2519 –2528

NienaberC A etal. C irc C ard iovasc Interv 2013; 6: 407 -416

• Death

• 3 years to catch up to early risk

• Rupture

• Stroke

• Paralysis

• Improved early mortality but at late cost

• Exact opposite of argument for EVAR

• EVAR1, DREAM data

• Medicare data

• Randomized trial: Uncomplicated ATBAD

• BMT: 31 patients (3 crossovers to TAG)

• BMT + TAG: 30 patients

• Freedom from:

• Incomplete or no false lumen thrombosis

• Aortic dilatation ≥5 mm or max diameter ≥ 55 mm

• Aortic rupture• Aortic rupture

Eu rJV asc End ovasc Su rg2014;48 :28 5-91

• Primary endpoint favored TEVAR (p<0.001)

• Incomplete FLT: 43% TEVAR v 97% BMT (p<0.001)• Incomplete FLT: 43% TEVAR v 97% BMT (p<0.001)

• False lumen ↑ BMT, ↓ TEVAR (p<0.001)

• True lumen ↑ TEVAR, No ∆ BMT (p<0.001)• True lumen ↑ TEVAR, No ∆ BMT (p<0.001)

• Overall transverse diameter No ∆ BMT, ↓ TEVAR (p=0.062)

• Is there any surprise here?

• What about mortality?• What about mortality?

• None in BMT one in TEVAR at one year

• Number of vessels originating from the falselumen as an independent predictor of falselumen growth in uTBAD patientslumen growth in uTBAD patients

• Increasing age was a negative predictor ofaortic growth.aortic growth.

JV asc Su rg.2016 N ov 19.pii:S07 41-5214(16)3127 5-7

• Patients rapidly-expanding aneurysmsfollowing uncomplicated ATBAD

• Computational fluid dynamics (CFD)

• Greater percentage of flow through false lumen

• Greater wall shear stress

JV asc Su rg.2015A u g;62(2):27 9-8 4.

• Mid-term outcomes and aortic remodelling afterTEVAR for aTBAD, saTBAD (2-12w), cTBA

• 100pts Rx Valiant device 3 year f/u

• A=50, SA=24, C=26

• 3 yr all-cause mortality (18%, 4%, and 24%)

• Dissection related mortality (12%, 4%, and 9%)• Dissection related mortality (12%, 4%, and 9%)

• Aortic reintervention rates (20%, 22%, and 39%)

• 2 retrograde type A both acute

Eu rJV asc End ovasc Su rg.2014 O ct;48 (4):363-7 1.

• Ascending aortic involvement

• Saccular false lumen• Saccular false lumen

• Large entry site tear (>10-15mm)

• Aortic size >44cm• Aortic size >44cm

• TL compression >30% of overall diameter

• FL diameter >22mm• FL diameter >22mm

• Partial FL thrombosis

• Medical management of uncomplicated TBAD haslow early mortality

• In experienced hands TEVAR has extremely low• In experienced hands TEVAR has extremely lowmortality as well but has complications

• We need more data to figure out if TEVAR lowers• We need more data to figure out if TEVAR lowerslong term mortality in uncomplicated TBAD

• We need to identify low-risk group to follow and highrisk groups to treatrisk groups to treat

• We need a randomized trial