Santi Trimarchi, MD, PhD Vascular Surgeon Thoracic Aortic Research Center, Director IRCCS Policlinico San Donato University of Milan
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1 The Gore GREAT Registry: Update about a real life data collection Santi Trimarchi, MD, PhD Vascular Surgeon Thoracic Aortic Research Center, Director IRCCS Policlinico San Donato University of Milan
2 Disclosures Grants: Italian National Research Council (CNR), CARIPLO Foundation, San Donato Foundation, Gore WL. Consultant: Gore WL, Medtronic inc. PI: GREAT registry
3 Overview Observational (on-label and off-label use)
4 Overview Observational (on-label and off-label use) 5000 patients at up to 300 sites worldwide
5 Overview Observational (on-label and off-label use) 5000 patients at up to 300 sites worldwide Commercial aortic endovascular products in global markets (US, EU, Australia, New Zealand, and Brazil)
6 GREAT Objectives Gore has developed an Aortic Registry to: Identify global trends in device usage Track long-term device performance and patient outcomes Post-marketing surveillance requirements Provide worldwide exposure on Gore product effectiveness Become a global clinical research organization to include sites OUS for investigational product evaluations
7 GREAT Objectives Gore has developed an Aortic Registry to: Identify global trends in device usage Track long-term device performance and patient outcomes Post-marketing surveillance requirements Provide worldwide exposure on Gore product effectiveness Become a global clinical research organization to include sites OUS for investigational product evaluations
8 GREAT Overview Outcomes Evaluation (EVAR and TEVAR) GRT Demographics, Medical History, Case Planning, Treatment Post-Treatment follow-up through 10 years including any Serious Adverse Events
9 GREAT Overview Outcomes Evaluation (EVAR and TEVAR) GRT 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
10 GREAT Overview Outcomes Evaluation (EVAR and TEVAR) GRT 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 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
11 GREAT Data Quality Database design: Data points must meet data standard conformity Critical data points identified System queries generated
12 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
13 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
14 Overall Enrollment and Follow up by Region 2331 pts
15 Enrollment - thoracic 390 subjects enrolled with a thoracic aortic diseases 28 in the aortic arch 19 in the ascending aorta 343 in the descending thoracic aorta
16 Aortic Pathologies - Descending Descending Thoracic aortic aneurysm 43% Type B complicated aortic dissection 18% Type B uncomplicated aortic dissection 13% Penetrating aortic ulcer 10% Traumatic aortic transection 7% Other 5% Descending Thoracic aneurysm rupture 2% Intramural hematoma 2% Pseudoaneurysm 1% Aortic coarctation < 1% Aorto-bronchial fistula Ascending Thoracic aneurysm rupture
17 Demographics Descending Male Female 71% 29% Age (ys) Mean (std dev) 65(14)
18 Treatment - Descending Procedure Survival 99% Median Hospital stay (days) 6
19 Treatment - Descending Procedure Survival 99% Median Hospital stay (days) 6 Thoracic Landing Zone Z0 3% Z1 5% Z2 24% Z3 52% Z4 16%
20 Aortic Branch Vessel Data Descending Aortic Branch Vessel Procedure 21%
21 Aortic Branch Vessel Data Descending Aortic Branch Vessel Procedure 21% Brachiocelphalic Trunk N=9 Covered/embolized 0 Surgical de-branch 78% Stent only 11% Chimney 11%
22 Aortic Branch Vessel Data Descending Aortic Branch Vessel Procedure 21% Brachiocelphalic Trunk N=9 Covered/embolized 0 Surgical de-branch 78% Stent only 11% Chimney 11% Left Common Carotid N=23 Covered/embolized 0 Surgical de-branch 78% Stent only 13% Chimney 9%
23 Aortic Branch Vessel Data Descending Aortic Branch Vessel Procedure 21% Brachiocelphalic Trunk N=9 Covered/embolized 0 Surgical de-branch 78% Stent only 11% Chimney 11% Left Common Carotid N=23 Covered/embolized 0 Surgical de-branch 78% Stent only 13% Chimney 9% Left Subclavian N=52 Covered/embolized 25% Surgical de-branch 64% Stent only 4% Chimney 14%
24 Pre-Treatment - Descending Lesion Diameter (mm) Mean (Std Dev) 61.7(13.8) Median 60.5 Range (7.5,110.0)
25 Pre-Treatment - Descending Lesion Diameter (mm) Mean (Std Dev) 61.7(13.8) Median 60.5 Range (7.5,110.0) Proximal Neck Length (cm) Mean (Std Dev) 5.0(4.2) Median 3.5 Range (0.5, 30.0)
26 Pre-Treatment - Descending Lesion Diameter (mm) Mean (Std Dev) 61.7(13.8) Median 60.5 Range (7.5,110.0) Proximal Neck Length (cm) Mean (Std Dev) 5.0(4.2) Median 3.5 Range (0.5, 30.0)
27 Pre-Treatment - Descending Lesion Diameter (mm) Mean (Std Dev) 61.7(13.8) Median 60.5 Range (7.5,110.0) Proximal Neck Length (cm) Mean (Std Dev) 5.0(4.2) Median 3.5 Range (0.5, 30.0) Distal Neck Length (cm) Mean (Std Dev) 7.1(6.5) Median 5.0 Range (0.0,30.0)
28 Serious Device Events Descending Total Procedure 1 Month 6 Months 1 Year 2 year Serious 0.3% 4.6% 5.0% 2.0% 0 3.8% Endoleak 1 Type IA % Type IB % Type II % Type III % Type IV
29 Serious Device Events Descending Total Procedure 1 Month 6 Months 1 Year 2 year Serious 0.3% 4.6% 5.0% 2.0% 0 3.8% Endoleak 1 Type IA % Type IB % Type II % Type III % Type IV
30 Serious Device Events Descending Total Procedure 1 Month 6 Months 1 Year 2 year Serious 0.3% 4.6% 5.0% 2.0% 0 3.8% Endoleak 1 Type IA % Type IB % Type II % Type III % Type IV
31 Serious Device Events Descending Total Procedure 1 Month 6 Months 1 Year 2 year Serious 0.3% 4.6% 5.0% 2.0% 0 3.8% Endoleak 1 Type IA % Type IB % Type II % Type III % Type IV Migration % Fracture Compression
32 Outcomes Over Time Descending Subjects With Any Follow-Up and/or Event 1 Procedure 1 Month 6 Months 1 Year 2 Year Total
33 Outcomes Over Time Descending Subjects With Any Follow-Up and/or Event 1 Procedure 1 Month 6 Months 1 Year 2 Year Total All Reinterventions 2 1.2% 3.8% 2.9% 2.5% 0 6.7% Conversion to Open Repair and/or Explant Additional Graft Other Procedure/Surgery Device Related Reinterventions
34 Outcomes Over Time Descending Subjects With Any Procedure 1 Month 6 Months 1 Year 2 Year Total Follow-Up and/or Event Mortality 0 10(2.9%) 12(6.9%) 4(4.9%) 1(4.0%) 27(7.9%)
35 Outcomes Over Time Descending Subjects With Any Procedure 1 Month 6 Months 1 Year 2 Year Total Follow-Up and/or Event Mortality 0 10(2.9%) 12(6.9%) 4(4.9%) 1(4.0%) 27(7.9%) Stroke/TIA 2 0 2(0.6%) (0.6%) Paraplegia/ Paraparesis/ Spinal Cord Is. 1(0.3%) 1(0.3%) 1(0.6%) 1(1.2%) 0 4(1.2%) Rupture 0 1(0.3%) 1(0.6%) 0 0 2(0.6%)
36 Aortic Pathologies - Ascending: 19 pts
37 Aortic Pathologies - Ascending: 19 pts Type A complicated aortic dissection 7 Ascending aneurysm 4 Pseudoaneurysm 2 Ascending aneurysm rupture 1 Type A uncomplicated dissection 1 Ascending dissection rupture 1 Other 3
38 Aortic Pathologies - Ascending: 19 pts Type A complicated aortic dissection 7 Ascending aneurysm 4 Pseudoaneurysm 2 Ascending aneurysm rupture 1 Type A uncomplicated dissection 1 Ascending dissection rupture 1 Other 3 Mean age: 61 (range 27 83)
39 Aortic Pathologies - Ascending: 19 pts Almost all procedures were reported as surgical debranching Only 2 chimney procedures reported. Mean(std dev) hospital stay was 14.5(13.2) days, range 2, 51 days.
40 Aortic Pathologies - Ascending: 19 pts Outcome data at 1 month: 1 type IA endoleak No migrations, fractures or compressions. 2 (11%) deaths (MOF at POD 21 and lung infection POD 35 ) 2 reinterventions (of which 1 is device related) reported.
41 Aortic Pathologies - Ascending: 19 pts Outcome data at 1 month: 1 type IA endoleak No migrations, fractures or compressions. 2 (11%) deaths (MOF at POD 21 and lung infection POD 35 ) 2 reinterventions (of which 1 is device related) reported.
42 Aortic Pathologies - Ascending: 19 pts Outcome data at 1 month: 1 type IA endoleak No migrations, fractures or compressions. 2 (11%) deaths (MOF at POD 21 and lung infection POD 35 ) 2 reinterventions (of which 1 is device related) reported.
43 Conclusions The Gore GREAT Registry: about a real life data collection This represents a GREAT opportunity to check pts at the very long-term FU
44 Conclusions The Gore GREAT Registry: about a real life data collection This represents a GREAT opportunity to check pts at the very long-term FU Numerous variables and pts enrolled that permit to stratify different cohorts
45 Conclusions The Gore GREAT Registry: about a real life data collection This represents a GREAT opportunity to check pts at the very long-term FU Numerous variables and pts enrolled that permit to stratify different cohorts
46 Conclusions The Gore GREAT Registry: about a real life data collection Re-Coarctation with dissection Type A Diss with Arch Tear FET Ao-Pulm. Fistulae
47 The Gore GREAT Registry: Update about a real life data collection Santi Trimarchi, MD, PhD Vascular Surgeon Thoracic Aortic Research Center, Director IRCCS Policlinico San Donato University of Milan
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