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The Endurant Stent Graft System: 1 Year Results of the US IDE Study

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The Endurant Stent Graft System: 1 Year Results of the US IDE Study

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    1. The Endurant® Stent Graft System: 1 Year Results of the US IDE Study Russell H. Samson MD for the Endurant Study Group

    2. Disclosure Investigator No payment for this talk

    4. Endurant Stent Graft System M-shaped proximal stent: good neck conformability Limb stent geometry designed for flexibility One-piece, laser cut, Nitinol suprarenal stent with anchoring

    5. Endurant Delivery System Accurate stepwise proximal deployment of the stent graft Controlled release of the suprarenal anchoring pins

    6. Endurant Delivery System Accurate stepwise proximal deployment of the stent graft Controlled release of the suprarenal anchoring pins

    7. Endurant Delivery System Accurate Proximal Deployment

    8. Endurant Stent Graft System

    9. Endurant US IDE Study Design: Non Randomized, Multi-center Study Population: N = 150 patients Enrollment : June 2008 to April 2009 Sites: 26 Sites Core Lab: All imaging reviewed by M2S Safety: Clinical Events Committee (CEC) adjudication of all untoward events

    10. Endurant US Study Sites 26 Sites including Academic and Community Hospitals

    11. Patient Selection and Endpoints Select Inclusion Criteria AAA > 5 cm Neck Length > 10 mm Neck Angle < 60 degrees Iliac Fixation Length > 15 mm Suitable Access

    12. Patient Population (N = 150) Patient Demographics Age: 73.1 years + 8 Gender: 91.3% Males Aneurysm Characteristics* Max AAA size: 55.9 mm + 8.7 Neck Angulation: 35.2° + 13.7 Prox Neck Length: 31 mm + 14.3

    13. Patient Population (N = 150) Patient Demographics Comorbidities: Hypertension 86.7% Tobacco use of 10 + years 44% Arrhythmia 39.3% COPD 35.3% Myocardial Infarction 30% Abnormal Renal Function 28.7% Diabetes 26.7% Peripheral Vascular Disease 22.7% Angina 18% Congestive Heart Failure 16%

    14. Procedure Outcomes Successful Deployment 99.3% Pieces per Case 2.93 Procedure Duration 101.5 min + 46.2 General Anesthesia 83.3% Blood Loss 184.9 mL + 167.9 Blood Transfusion Required 0.7% Length of Stay 2.1 days + 2.3 Successful Deployment Background Subject is a 68 year old male who underwent Endurant Stent Graft System implantation on 11/14/2008. During the procedure, the main bifurcated stent graft was successfully deployed without incident. As the physician was about to deploy the contralateral limb, he was unable to cannulate the gate of the main bifurcated body despite trying different approaches due to preexisting challenging anatomy (severe calcification disease in distal aorta and a pre-exiting thrombus inside the aneurysm sac), and ultimately converted to aorto-uni-iliac and then a fem-fem bypass. Once the procedure was completed, there was good graft apposition and widely patent left common iliac and external iliac arteries. The subject was discharged three days later on 11/17/2008. Aneurysm Rupture Subject is an 88 year old female who underwent Endurant Stent Graft System implantation on 06/25/2008. During the procedure, the stent graft was successfully delivered and deployed. Repeat angiography revealed a significant Type I endoleak on the left side of the aneurysm and additional balloon dilatation was performed. During this maneuver, the subject’s systolic blood pressure dropped and arteriography revealed an aneurysm sac rupture. The Reliant Balloon was inflated to control bleeding. An aortic cuff was placed across the proximal portion of the endograft to seal off the aneurysm rupture. Final angiography revealed no evidence of kinking ortwisting, endoleak or bleeding from the rupture site and good flow to renal and hypogastric vessels. The subject was discharged on 06/28/2008. Successful Deployment Background Subject is a 68 year old male who underwent Endurant Stent Graft System implantation on 11/14/2008. During the procedure, the main bifurcated stent graft was successfully deployed without incident. As the physician was about to deploy the contralateral limb, he was unable to cannulate the gate of the main bifurcated body despite trying different approaches due to preexisting challenging anatomy (severe calcification disease in distal aorta and a pre-exiting thrombus inside the aneurysm sac), and ultimately converted to aorto-uni-iliac and then a fem-fem bypass. Once the procedure was completed, there was good graft apposition and widely patent left common iliac and external iliac arteries. The subject was discharged three days later on 11/17/2008. Aneurysm Rupture Subject is an 88 year old female who underwent Endurant Stent Graft System implantation on 06/25/2008. During the procedure, the stent graft was successfully delivered and deployed. Repeat angiography revealed a significant Type I endoleak on the left side of the aneurysm and additional balloon dilatation was performed. During this maneuver, the subject’s systolic blood pressure dropped and arteriography revealed an aneurysm sac rupture. The Reliant Balloon was inflated to control bleeding. An aortic cuff was placed across the proximal portion of the endograft to seal off the aneurysm rupture. Final angiography revealed no evidence of kinking ortwisting, endoleak or bleeding from the rupture site and good flow to renal and hypogastric vessels. The subject was discharged on 06/28/2008.

    15. Clinical and Imaging Follow-Up Schedule: 1, 6, 12 Months Follow-Up Clinical Visit CT with Contrast and 4 View Abdominal X-Ray Patients with elevated SCr had non contrast CT with ultrasound duplex or MRA All Imaging Reviewed by Core Lab

    16. 30 Day Outcomes Mortality 0% Major Adverse Events (MAE) 4.0% Myocardial Infarction 0.7% Renal Failure 0.7% Respiratory Failure 1.3% Stroke 0.7% Bowel Ischemia 1.3% Procedural Blood Loss >1000 mL 0.7% Two patients had limb occlusions (Day 1 and Day 20) MAE = All cause mortality, bowel ischemia, MI, paraplegia, procedural blood los >= 1000 cc, renal failure, respiratory failure and stroke MI : Patient had chest pain post op. EKG positive for ST and T wave abnormalities. Patient showed irregular EKG patterns and increased cardiac enzymes which decreased over 2 days. Patient discharged without incident on day 2. Renal Fail : Patient with history of renal insufficiency. Unable to void 3 days post op had SCr of 4.69. Readmitted for acute tubular necrosis. Discharged 6 days later with Scr of 1.87. Respiratory Fail : Patient 1 : Required re-intubation upon admission to the ICU. Pt given breathing treatment and IV diuretics Extubated later that day without incident. Blood Loss : Difficult to close calcified access sites during procedure. Bovine patches were applied bilaterally. Flow ultimately restored, however 1450 cc blood loss due to difficulty of the repair 1 patient accounted for the additional Stroke, Bowel Ischemia, and Respiratory Failure wthin the first 30 days. Patient had ahx of a fib, DVT, splenectomy, and diverticulosis.MAE = All cause mortality, bowel ischemia, MI, paraplegia, procedural blood los >= 1000 cc, renal failure, respiratory failure and stroke MI : Patient had chest pain post op. EKG positive for ST and T wave abnormalities. Patient showed irregular EKG patterns and increased cardiac enzymes which decreased over 2 days. Patient discharged without incident on day 2. Renal Fail : Patient with history of renal insufficiency. Unable to void 3 days post op had SCr of 4.69. Readmitted for acute tubular necrosis. Discharged 6 days later with Scr of 1.87. Respiratory Fail : Patient 1 : Required re-intubation upon admission to the ICU. Pt given breathing treatment and IV diuretics Extubated later that day without incident. Blood Loss : Difficult to close calcified access sites during procedure. Bovine patches were applied bilaterally. Flow ultimately restored, however 1450 cc blood loss due to difficulty of the repair 1 patient accounted for the additional Stroke, Bowel Ischemia, and Respiratory Failure wthin the first 30 days. Patient had ahx of a fib, DVT, splenectomy, and diverticulosis.

    17. 30 Day Outcomes Fever Explanation : 9 subjects had post-op fever. All occurred within the first 3 days of the procedure. Considered an SAE because it prolonged hospitalization. Explanation: “post-implantation syndrome”, a commonly observed occurrence after endovascular aortic repair, which completely resolved after intravenous corticosteroid therapy. Post-implantation syndrome is characterized by fever, elevated C-reactive protein levels, and leukocytosis in the absence of an infectious agent. It is hypothesized that endovascular aortic aneurysm repair induces a significant inflammatory response, resulting in endothelial cell activation from intra-aneurysmal device manipulation. Vascular Events : Primarily arterial access related Fever Explanation : 9 subjects had post-op fever. All occurred within the first 3 days of the procedure. Considered an SAE because it prolonged hospitalization. Explanation: “post-implantation syndrome”, a commonly observed occurrence after endovascular aortic repair, which completely resolved after intravenous corticosteroid therapy. Post-implantation syndrome is characterized by fever, elevated C-reactive protein levels, and leukocytosis in the absence of an infectious agent. It is hypothesized that endovascular aortic aneurysm repair induces a significant inflammatory response, resulting in endothelial cell activation from intra-aneurysmal device manipulation. Vascular Events : Primarily arterial access related

    18. 1 Year Outcomes All Cause Mortality 6 patients died - None AAA related (CEC) Primary Cause of Death Days Post-Implant Stroke 90 COPD 128 Pulmonary Fibrosis 215 Lung Cancer 267 Multiple Organ/System Failure 280 Metastatic Bladder Cancer 320 Stroke : Pt experienced post operative stroke x2. despite adequate warfarin tx with therapeutic INR. Pt readmitted with UTI and elevated SCr, Bilateral pneumonia positive on chest xray. Pt began to deteriorate. Care withdrawn (DNR) Multi system Organ Failure : Patient was admitted for declining acute chronic renal failure. Dialysis was started. During dialysis asymptomatic v-tach episode noted. ICD placed for ischemic cardiomyopathy with EF less than 30%. Patients respiratory status further declined in the hospital with onset of hypotension and possible sepsis. Family withdrew care.Stroke : Pt experienced post operative stroke x2. despite adequate warfarin tx with therapeutic INR. Pt readmitted with UTI and elevated SCr, Bilateral pneumonia positive on chest xray. Pt began to deteriorate. Care withdrawn (DNR) Multi system Organ Failure : Patient was admitted for declining acute chronic renal failure. Dialysis was started. During dialysis asymptomatic v-tach episode noted. ICD placed for ischemic cardiomyopathy with EF less than 30%. Patients respiratory status further declined in the hospital with onset of hypotension and possible sepsis. Family withdrew care.

    19. 1 Year Outcomes

    20. AAA Size Change at 1 Year

    21. AAA Size Change at 1 Year Significant sac shrinkage > 1 cm notedSignificant sac shrinkage > 1 cm noted

    22. Endoleaks Over Time

    23. Re-Interventions Day 1 : The right limb graft occlusion occurred 1 day post implant resulting from a sharp bend with significant calcification in the narrow left common iliac artery. There was greater than 50% over-sizing of the limbs around the kink, and it was resolved by deploying an AneuRx extension Day 30 : The compression and occlusion of the right limb occurred above the aneurysm, due to a long narrow neck with a bend proximal to the AAA, and the neck tapers down to 15 mm. Also, the anatomy had poor outflow with external right iliac measuring 4 mm at certain places due to high calcification. The limb extensions were oversized by >70%. In summary, the contributing factors to the left limb graft occlusion are significant over-sizing of the left iliac limb in the small, tortuous and calcified right common iliac artery. Resolved by Fem-fem bypass. Day 47: Right limb graft occlusion resulting from compression of a thrombus of the proximal right limb graft at the aortic bifurcation. Contributing factors include: Large device used to provide apposition to the aneurismal common iliac arteries which had no distal landing zone, poor outflow due to severely tortuous anatomy, and calcification. Day 56: Left limb graft occlusion resulting from a sharp angulation (65-75 degrees) in the distal LCIA just beyond the end of the graft limb and stenosis in the left common iliac artery Day 304: an aortagram with runoff was completed. Stent-graft kinking at the left iliac gate region and stent graft stenosis were revealed. Approximately 70% stenosis of the subject’s left iliac limb was noted. Subsequently on the same day, the subject underwent angiography of the right and left iliac arteries and percutaneous transluminal angioplasty. A Visi-Pro left common iliac artery stent was deployed to the left iliac limb of the Endurant stent graft. Following angioplasty, final angiography revealed that the previous left iliac limb 70% stenosis was reduced to 20%, and the right limb demonstrated no residual stenosis. Successful angioplasty and stent deployment were indicated. There was no evidence of endoleaks, device kinking, twisting, malfunction, or other complications. The stenosis was reported as related to the device and not the procedure, and resolved on procedure day. The subject was discharged on the same day as the procedure.Day 1 : The right limb graft occlusion occurred 1 day post implant resulting from a sharp bend with significant calcification in the narrow left common iliac artery. There was greater than 50% over-sizing of the limbs around the kink, and it was resolved by deploying an AneuRx extension Day 30 : The compression and occlusion of the right limb occurred above the aneurysm, due to a long narrow neck with a bend proximal to the AAA, and the neck tapers down to 15 mm. Also, the anatomy had poor outflow with external right iliac measuring 4 mm at certain places due to high calcification. The limb extensions were oversized by >70%. In summary, the contributing factors to the left limb graft occlusion are significant over-sizing of the left iliac limb in the small, tortuous and calcified right common iliac artery. Resolved by Fem-fem bypass. Day 47: Right limb graft occlusion resulting from compression of a thrombus of the proximal right limb graft at the aortic bifurcation. Contributing factors include: Large device used to provide apposition to the aneurismal common iliac arteries which had no distal landing zone, poor outflow due to severely tortuous anatomy, and calcification. Day 56: Left limb graft occlusion resulting from a sharp angulation (65-75 degrees) in the distal LCIA just beyond the end of the graft limb and stenosis in the left common iliac artery Day 304: an aortagram with runoff was completed. Stent-graft kinking at the left iliac gate region and stent graft stenosis were revealed. Approximately 70% stenosis of the subject’s left iliac limb was noted. Subsequently on the same day, the subject underwent angiography of the right and left iliac arteries and percutaneous transluminal angioplasty. A Visi-Pro left common iliac artery stent was deployed to the left iliac limb of the Endurant stent graft. Following angioplasty, final angiography revealed that the previous left iliac limb 70% stenosis was reduced to 20%, and the right limb demonstrated no residual stenosis. Successful angioplasty and stent deployment were indicated. There was no evidence of endoleaks, device kinking, twisting, malfunction, or other complications. The stenosis was reported as related to the device and not the procedure, and resolved on procedure day. The subject was discharged on the same day as the procedure.

    24. Aortouniliac Endurant We have performed 3 with excellent early results

    25. Summary and Conclusions

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