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April 6, 2017 Copyright UPM-Kymmene Group 1 The Standard of Care for Chronic Type B Dissection is Endovascular Repair Benjamin W. Starnes MD, FACS The Alexander Whitehill Clowes MD Endowed Chair of Vascular Surgery Professor of Surgery Chief, Division of Vascular Surgery University of Washington Seattle, WA Disclosures Co-Founder: AORTICA Corporation Will the REAL Michael Conte please stand up! Scientist Open Surgeon Endovascular Surgeon What do we know about Conte? Extremely Smart Very Charismatic Good Looking Fit Great Technical Surgeon Good Common Sense

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April 6, 2017

Copyright UPM-Kymmene Group 1

The Standard of Care for Chronic Type B Dissection is Endovascular Repair

Benjamin W. Starnes MD, FACSThe Alexander Whitehill Clowes MD Endowed Chair of Vascular Surgery

Professor of SurgeryChief, Division of Vascular Surgery

University of WashingtonSeattle, WA

Disclosures

• Co-Founder: AORTICA Corporation

Will the REAL Michael Conte please stand up!

Scientist Open Surgeon

Endovascular Surgeon

What do we know about Conte?

• Extremely Smart

• Very Charismatic

• Good Looking

• Fit

• Great Technical Surgeon

• Good Common Sense

April 6, 2017

Copyright UPM-Kymmene Group 2

46 yo Marfan’s 10/11/2007

10/11/2007 2/27/2008 1/5/2011 3/7/2015

7.5 Year Follow Up ?

April 6, 2017

Copyright UPM-Kymmene Group 3

Open Surgery for CTBAD

• 10% 30 Day Mortality

• 10% Paraplegia

• 10% Renal Failure (Half go on to Dialysis)

• 10% Pulmonary Failure

Leshnower BG, Szeto WY, Pochettino A, Desai ND, Moeller PJ,Nathan DP, et al. Thoracic endografting reduces morbidity and remodelsthe thoracic aorta in DeBakey III aneurysms. Ann Thorac Surg2013;95:914-21.

Estrera AL, Sandhu H, Afifi RO, Azizzadeh A, Charlton-Ouw K,Miller CC, et al. Open repair of chronic complicated type B aorticdissection using the open distal technique. Ann Cardiothorac Surg2014;3:375-84.

Aortic Dissection- Classification

Stanford Type A Type B

DeBakey

Type B Aortic Dissection-University of Washington Strategy

Diagnosis with CTA

No Malperfusion

Medical TherapyB- Blockade / VasodilatorDecrease dP/dT

Malperfusion / Rupture

Endovascular Therapy-Routine IVUS+/- Stent Graft+/- Rapid RV Pacing+/- Fenestration

Acute Type B Dissection

What About Chronic Type B Dissection (CAD)?

• Aneurysmal degeneration occurs in ~30%

• Open surgical repair associated with high morbidity and mortality

• TEVAR for CAD is controversial- little outcome data

April 6, 2017

Copyright UPM-Kymmene Group 4

Pre Post

Pre Post Pre Post

Complete false lumen thrombosis- Aneurysm 1cm smaller in 3 weeks, hoarseness resolved

April 6, 2017

Copyright UPM-Kymmene Group 5

5/24/2005 4/14/2010

• TX-2 38 x 202 Prox (based on 34mm D)

• TX-2 40 x 216 Dist (based on 40mm D)

April 6, 2017

Copyright UPM-Kymmene Group 6

5/24/2005 8/13/20124/14/2010

Sometimes this strategy doesn’t work…

7/14/2010 4/18/2012

April 6, 2017

Copyright UPM-Kymmene Group 7

8/7/2012

35 ManuscriptsChronic Aortic Dissection x TEVAR

Results

• 17 studies

• 567 patients

• Technical Success- 89.9%

• 30-day mortality- 3.2%

• Mid-term Mortality 9.2% (46/499)

• Survival 59.1 – 100% in studies with mean f/u of 24 months

Eur J Vasc Endovasc Surg (2011) 42, 632e647

Results

• Complications– Rare!

• Retrograde Type A Dissection – 0.67%

• Aorto-Esophageal Fistula- 0.22%

• Paraplegia- 0.45%

• Stroke- 1.5%

• Death at 30 days- 3.2%

Eur J Vasc Endovasc Surg (2011) 42, 632e647

April 6, 2017

Copyright UPM-Kymmene Group 8

Eur J Vasc Endovasc Surg (2011) 42, 632e647 European Journal of Vascular and Endovascular Surgery 43 (2012) 386e391

• Cleveland Clinic- 2000-2007– 76 patients / 144 stent grafts, Mean F/U 34 months

– 30-day mortality -5%

– Paraplegia -0%

– One CVA –1.3%

– Survival at 1, 2 and 3 yrs / 86%, 82% and 80%

• Peri-operative risk of TEVAR for CAD is extremely low when compared to modern open surgical series.

• False lumen thrombosis correlates with favorable mid-term outcomes.

• The absolute benefit of TEVAR over alternative treatments for CAD remains uncertain.

• High quality data from registries and clinical trials are required to address these challenges.

April 6, 2017

Copyright UPM-Kymmene Group 9

TEVAR for CAD

• Methods:– Retrospective review of consecutive TEVARs for CAD

– 2008-2013

– Primary Outcome- 30 day Mortality

– Secondary Outcomes-• False Lumen Thrombosis

• Aneurysm Sac Shrinkage

• “Positive” Aortic Remodeling

TEVAR for CAD

• Results:– 45 TAA / CAD cases were treated with TEVAR

• 73% male

• Median Age 60 (37-71)

• Median time to presentation- 56 months

• Five cases secondary to Marfan’s

• Seven Type A CAD with previous ascending repair

• 38 Type B CAD

– Staged approach in 7 cases and Hybrid in 8

TEVAR for CAD- Results

• Adjunctive Procedures– Spinal Drainage (n=42)

– Left C-SCA Bypass (n=21)

• Proximal Landing Zone– Zone 2 (n=24)

– Zone 3 (n=21)

April 6, 2017

Copyright UPM-Kymmene Group 10

TEVAR for CAD- Results

• No procedural mortality

• Complications:– CVA (n=1) 2.2%

– Transient Renal Failure (n=3) 6.7%• Creat elevation > 20%- all returned to normal

• Median Hospital LOS= 6 days (range 1-16)

TEVAR for CAD- Results• All 1 month f/u CTAs

– Complete False Lumen Thrombosis throughout length of stent graft in all but one case

– Endoleaks- Two cases• 1 Type 2- no intervention

• 1 type 1B- distal extension- (the only secondary intervention)

– Aneurysm Exclusion• Sac Shrinkage-(“Positive Aortic Remodeling)

– median 0.5 cm (range 0-2.4cm)

• No aneurysm enlarged

TEVAR for CAD

• TEVAR for CAD is associated with acceptable rates of morbidity and mortality when compared with standard open repair

• False lumen thrombosis and sac shrinkage is associated with positive aortic remodeling in a majority of patients

• Long term follow up is needed to understand the success of this strategy

April 6, 2017

Copyright UPM-Kymmene Group 11

Will the REAL Michael Conte please stand up!

Scientist Open Surgeon

Endovascular Surgeon