Performance of the conformable GORE TAG device in Type B aortic dissection from the GORE GREAT real world registry

University of Milan Thoracic Aortic Research Center Performance of the conformable GORE TAG device in Type B aortic dissection from the GORE GREAT real world registry Santi Trimarchi, MD, PhD Associate Professor of Vascular Surgery, University of Milan Head, Unit of Vascular Surgery II Director, Thoracic Aortic Research Center IRCCS Policlinico San Donato

Disclosures Grants: Italian National Research Council (CNR), CARIPLO Foundation, San Donato Foundation, Gore WL, Medtronic inc. Consultant and Speaker: Gore WL, Medtronic inc.

Complicated Type B Dissection: Guidelines ESC 2014

Complicated Acute B Dissection TEVAR: 9-11 % mortality Open repair: 29-32 % mortality Circulation 2005 JACC Int. 2008

Aortic Remodeling after TEVAR for Type B Aortic Dissection Aortic Remodeling in Acute Uncomplicated Type B Dissections Aortic Remodeling in Complicated Type B Dissections Aortic Remodeling in Chronic Type B Dissections Baseline After 2 years

Aortic Remodeling in Acute Uncomplicated Type B Dissections Acute uncomplicated type B dissections randomized: BMT vs. TEVAR Incomplete false lumen thrombosis 13 (43%) TEVAR vs. 30 (97%) BMT (p <.001)

Aortic Remodeling in Acute Uncomplicated Type B Dissections Acute uncomplicated type B dissections randomized: BMT vs. TEVAR TL increase TEVAR vs. no change BMT

Aortic Remodeling in Acute Uncomplicated Type B Dissections Acute uncomplicated type B dissections randomized: BMT vs. TEVAR FL reduction in the TEVAR group vs. FL increase in BMT group

Aortic Remodeling in Chronic Type B Dissection Chronic type B aortic dissections randomized to TEVAR or OMT Benefit of TEVAR for all end points at 5 years All-cause mortality (0% versus 16.9%; P=0.0003) Aorta-specific mortality (0% versus 16.9%; P=0.0005) Progression of dissection (4.1% versus 28.1%; P=0.004) Baseline and 5y FU

Aortic Remodeling in Chronic Type B Dissection Chronic type B dissection patients (n=51) treated with TEVAR At 2-year FU : Overall aortic diameter decrease from 6.2cm to 5.0 cm (P =.0002) 87% of patients showed complete reverse remodeling of the thoracic aorta Baseline 2y FU

Aortic Remodeling in Type B Dissection Acute (n=50), subacute (n=24) and chronic dissections (n=26) treated with TEVAR True lumen increase after TEVAR in all groups without differences

Aortic Remodeling in Acute and Subacute Type B Dissection Acute (n=50), subacute (n=24) and chronic dissections (n=26) treated with TEVAR FL decrease most prominent in acute and subacute

Aortic Remodeling in Chronic Type B Dissection Acute (n=50), subacute (n=24) and chronic dissections (n=26) treated with TEVAR FL decrease most prominent in acute and subacute FL decrease less in chronic dissection

Aortic Remodeling in Chronic Type B Dissection Acute (n=50), subacute (n=24) and chronic dissections (n=26) treated with TEVAR FL thrombosis percentage increased after TEVAR

Aortic Remodeling in Chronic Type B Dissection Acute (n=50), subacute (n=24) and chronic dissections (n=26) treated with TEVAR FL thrombosis percentage between diaphragm and coeliac axis was significantly lower in chronic dissections compared to acute and subacute dissections (p=0.035)

Volumetric Changes of Aortic Remodeling in Type B Dissections Analysis of CT-scans after TEVAR for uncomplicated chronic dissection (A) and chronic dissection with aneurysm (B) Stent graft proximally increasing 4.4%, 10.1%, and 14.2%, respectively, at 6, 12, and 36 months Stent graft distally increasing 42.6%, 67.2%, and 72.3%, respectively, at 6, 12, and 36 months Proximal stent Distal stent

Volumetric Changes of Aortic Remodeling in Type B Dissections Analysis of CT-scans after TEVAR for uncomplicated chronic dissection (A) and chronic dissection with aneurysm (B) FL thrombus volume decrease with shrinkage but FL thrombus percentage increase FL thrombus volume and percentage Aortic remodeling is a continuous process

Predictors of FL thrombosis after TEVAR

Volumetric Changes after TEVAR Thoracic TL volume Thoracic FL volume

Overview

Overview Commercial aortic endovascular products in global markets (US, EU, Australia, New Zealand, and Brazil) 5000 patients at up to 300 sites worldwide Observational (on-label and off-label use) 10 yrs Follow Up

GREAT Overview Outcomes Evaluation (EVAR and TEVAR) GRT 10-11 Demographics, Medical History, Case Planning, Treatment Post-Treatment follow-up through 10 years including any Serious Adverse Events Gore Excluder featuring C3 Delivery System GRT 10-12 Primary Objectives Evaluate procedural outcomes, to include: Estimation of the number of aortic extenders required per case Qualitative assessment of the repositioning capabilities of the device Qualitative assessments of device deployment accuracy

GREAT Data Quality Database design: Data points must meet data standard conformity Critical data points identified System queries generated In-house data monitoring: Independent reviewers Adverse Event Reviews Manual queries generated Site monitoring: For cause monitoring & site support Monitoring plan revised based on observations and need

GREAT Data Quality > 3500 patients enrolled

Aortic Pathologies Treated Abdominal aortic aneurysm 71% Common iliac aneurysm 10% Descending Thoracic aortic aneurysm 7% Type B complicated aortic dissection 3% Type B uncomplicated aortic dissection 2% Penetrating aortic ulcer 2% Abdominal aortic aneurysm rupture 3% Thoracoabdominal aortic aneurysm 2% Internal iliac aneurysm 2% < 2% Traumatic transection Pseudoaneurysm Aortic arch aneurysm Descending Thoracic aneurysm rupture Intramural hematoma Thoracoabdominal aneurysm rupture Type A complicated dissection Ascending Thoracic aneurysm Aortic arch aneurysm rupture Aortic coarctation Aorto-bronchial fistula Ascending Thoracic aneurysm rupture Descending aortic dissection rupture Type A uncomplicated dissection

The Gore GREAT Registry A real life data collection Re-Coarctation with dissection Type A Diss with Arch Tear FET Ao-Pulm. Fistulae

Type B Dissection Classification Acute, complicated (n=67) is defined as time from symptom onset to diagnosis 14 days with site reported complicated. Acute, uncomplicated (n=44) is defined as time from symptom onset to diagnosis 14 days with site reported uncomplicated. Chronic (n=67) is site reported time from symptom onset to diagnosis is >14 days.

Demographics Type B Dissections All N=177 Acute, Complicated N=67 Acute, Uncomplicated N=44 Chronic N=67 Male (%) 84% 79% 82% 90% Female (%) 16% 21% 18% 10% White/Caucasian (%) 67% 67% 71% 64% Age ys Mean (std dev) 62(12) 61(12) 62(12) 62(11)

Treatment data Type B Dissection sub-categories All N=177 Acute, Complicated N=67 Acute, Uncomplicated N=44 Chronic N=67 Procedure Survival 100.0% 100.0% 100.0% 100.0% Hospital Stay (days) Median 8 15 6 8

Treatment data Type B Dissection sub-categories All N=177 Acute, Complicated N=67 Acute, Uncomplicated N=44 Chronic N=67 Access Method Percutaneous 41% 39% 46% 42% Cut-down 70% 66% 60% 81% Surgical Conduit 3% 3% 7% 2% Access Site Femoral Artery 98% 99% 96% 100% Iliac Artery 2% 2% 5% 2% Infrarenal Aorta 0 0 0 0 Brachial 5% 9% 5% 2% Other 5% 3% 7% 5%

Treatment by landing zone All Type B Dissections 4% 51% 4% 31% 10%

Treatment data Type B Dissection sub-categories All N=177 Acute, Complicated N=67 Acute, Uncomplicated N=44 Chronic N=67 Thoracic Landing N=154 N=58 N=35 N=62 Zone Z0 4% 2% 3% 7% Z1 5% 3% 3% 7% Z2 51% 52% 34% 60% Z3 31% 35% 46% 18% Z4 10% 9% 14% 10% Aortic Branch Vessel Procedure 38% 42% 23% 45%

Aortic Branch Vessel Data Type B Dissection sub-categories

Follow up Type B Dissection Follow Up Time (Days) All Type B dissections n 150 Median 129 Range (0,841) There are no differences in follow up among the sub categories and both enrollment and follow up continue. Note: Follow-up time is defined as the time from initial procedure to the last known contact post discharge from initial procedure (however, deaths or withdrawals are counted as follow-up which can occur at any time point in the study).

30-Day Outcomes Type B dissection sub-categories All N=177 Acute, Complicated N=67 Acute, Uncompl N=44 Chronic N=67 Subjects With Any Event: 6% 5% 9% 4% Mortality 4 1 1 2 Stroke/TIA 1 2 2 0 0 Paraplegia/Paraparesis/ 2 0 1 1 Spinal Cord Ischemia 1 Device-related Reinterventions 2 1 1 0 0 1 Only those considered Serious Adverse Events 2 Device related reinterventions include any invasive or minimally invasive measure related to a deficiency of the device(s) implanted into the aorta performed at any time following the initial procedure.

Outcomes Over Time Type B dissection Subjects With Any Follow- Up and/or Event 1 Procedure 1 Month 6 Months 1 Year Total 177 154 106 50 177 Mortality 1³ 4 5 3 7% Stroke/TIA 2 0 2 0 0 1% Paraplegia/Paraparesis/ Spinal Cord Ischemia 2 1 1 1 1 2% 1 Subjects are counted in the denominator if either had any reported date of contact ³ start of window and/or reported event in the window; all subjects with initial procedure date are counted in Procedure and Total windows. 2 Only those considered serious adverse events. ³ The one death occurred post procedure but on POD 0.

1 Subjects are counted in the denominator if either had any reported date of contact ³ start of window and/or reported event in the window; all subjects with initial procedure date are counted in Procedure and Total windows. 2 All reinterventions include any invasive or minimally invasive measure related to the initial aortic procedure performed at any time following the initial procedure; device related reinterventions include any invasive or minimally invasive measure related to a deficiency of the device(s) implanted into the aorta performed at any time following the initial procedure. Outcomes Over Time Type B dissection Subjects With Any Follow- Up and/or Event 1 Procedure 1 Month 6 Months 1 Year Total 177 154 106 50 177 All Reinterventions 2 1% 4% 9% 2% 9% Conversion to Open 0 0 1 0 1 Repair and/or Explant Additional Graft 0 0 1 0 1 Other Procedure/Surgery 1 6 8 0 15 Device Related Reinterventions 2 0 2 9 1 12

Serious Device Events over time Type B Dissection Total Procedure 1 Month 6 Months 1 Year Serious Endoleak 1 0 6% 8% 8% 7% Type IA 0 0 0 1 1 Type IB 0 1 1 1 3 Type II 0 1 4 0 5 Type III 0 1 0 0 1 Type IV 0 0 0 0 0 Migration 2 0 0 0 0 0 Fracture 0 0 0 0 0 Compression 0 0 0 0 0 1 Any type, including unspecified endoleaks 2 Does not include 'Device placement at incorrect location' or similar coded MedDRA term.

Conclusions

Conclusions Overall, Gore C-TAG performs nicely in TEVAR treatment of Type B dissection

Conclusions Overall, Gore C-TAG performs nicely in TEVAR treatment of Type B dissection Gore C-TAG promotes Aortic Remodeling in Type B dissection. In these pts, better results have been showed in the acute / subacute phases. 2 mts after dissection 3 mts after TEVAR 1 yr after TEVAR

Conclusions Overall, Gore C-TAG performs nicely in TEVAR treatment of Type B dissection Gore C-TAG promotes Aortic Remodeling in Type B dissection. In these pts, better results have been showed in the acute / subacute phases. The GORE GREAT Registry is a great opportunity to report both on common and uncommon aortic deseases.