Advances in Heart Disease: Endovascular Repair of Aortic Diseases - PDF document

Disclosures Scientific Advisor – Radial Medical Advances in Heart Disease: Endovascular Repair of Aortic Diseases Shant Vartanian, MD Assistant Professor of Surgery Division of Vascular and Endovascular Surgery Interim Chief of Surgery Zuckerberg San Francisco General Hospital Dec 2, 2017 2 Advances in Heart Disease 12/2/17 Endovascular Repair of Aortic Disease Albert Einstein Outline Death from ruptured AAA § Abdominal Aortic Aneurysms § Reinforced by Nissen 1948 • Natural History § Voorhees implants first prosthetic graft for AAA 1952 • Risk Factors § Einstein ruptures April 1955 • Open vs Endovascular Repair § Cooley and DeBakey pioneer • Branch technologies homograft for AAA 1955 § Thoracic Aortic Aneurysms § Cooley and Debakey popularize the use of § Aortic Dissection prosthetic grafts for repairs late • Endovascular interventions for acute dissections 1950’s • Indications for subacute interventions 3 Advances in Heart Disease 12/2/17 4 Advances in Heart Disease 12/2/2017 1 12/2/17 [ADD PRESENTATION TITLE: INSERT TAB > HEADER & FOOTER > NOTES AND HANDOUTS]

Introduction Natural History Focal dilation of > 50% larger than nominal arterial diameter Laplace’s Law: Wall tension is directly proportional to radius § Abdominal Aorta 3 cm § Common Iliac 2 cm § Fusiform vs Saccular § Degenerative vs Inflammatory § Infectious (mycotic) § Traumatic § Post Dissection Joon Bum Kim et al. Circulation. 2015;132:1620-1629 § Multifocal 5 Advances in Heart Disease 12/2/17 6 Advances in Heart Disease 12/2/17 Natural History Smoking and AAA Risk Rupture Risk § Aneurysm shape § Female gender § Smokers § HTN § COPD § Family history § Expansion rate § Biomarkers? Kent et al. JVS vol 52(3) 2010 § Genetic profile? 7 Advances in Heart Disease 12/2/17 8 Advances in Heart Disease 12/2/17 2 12/2/17 [ADD PRESENTATION TITLE: INSERT TAB > HEADER & FOOTER > NOTES AND HANDOUTS]

Aneurysm Progression Protection from AAA Optimal medical management Influence of smoking Br J Surg. 2012;99(5):655-65. Kent et al. JVS vol 52(3) 2010 9 Advances in Heart Disease 12/2/17 10 Advances in Heart Disease 12/2/17 Protection from AAA Natural History Diabetes is Protective Expansion rate: Normal is 3 mm / year Br J Surg. 2012;99(5):655-65. 11 Advances in Heart Disease 12/2/17 12 Advances in Heart Disease 12/2/17 3 12/2/17 [ADD PRESENTATION TITLE: INSERT TAB > HEADER & FOOTER > NOTES AND HANDOUTS]

Screening and Surveillance Open Repair in the Modern Era Estimated complication rate in society practice guidelines § Screening • 4 randomized trials with total 137,233 patients • Screening reduces aneurysm related mortality • Est 216 men need to be screened to save one death • US Preventative Services Task Force (USPSTF) recommends one time screening for men age 65-75 who have ever smoked § Surveillance AAA Size Surveillance Interval 3.0 – 3.9 cm 3 years 4.0 – 4.9 cm 12 months 6-8 week recovery 5.0 – 5.4 cm 6 months 13 Advances in Heart Disease 12/2/17 14 Advances in Heart Disease 12/2/17 Endovascular Repair EndoVascular AAA Repair (EVAR) Disruptive innovation Security of the repair relies solely upon the radial force generated by the graft at the landing zones § Anatomic suitability • Aneurysm neck ‒ Length, diameter, angulation ‒ Atheroma, thrombus • Iliac seal zones • Access vessels • Critical branch vessels ‒ Accessory renal arteries 15 Advances in Heart Disease 12/2/17 16 Bakersfield Cardiovascular Symposium 12/2/17 4 12/2/17 [ADD PRESENTATION TITLE: INSERT TAB > HEADER & FOOTER > NOTES AND HANDOUTS]

FDA Approved Devices Anatomic Criteria for Devices on Market Seal in Normal Aorta: Staying within the IFU 17 Advances in Heart Disease 12/2/17 18 Advances in Heart Disease 12/2/17 Complications of Endovascular Repair Long Term Complications Early and Late complications Endoleaks 5% 20% <5% <5% Balloon Rx only if sac growth Bridge the gap Present at implantation Raise the seal zone Embolization Seals sponteaneously Compliance with surveillance necessary for durable outcomes Endoanchor 19 Advances in Heart Disease 12/2/17 20 Advances in Heart Disease 12/2/17 5 12/2/17 [ADD PRESENTATION TITLE: INSERT TAB > HEADER & FOOTER > NOTES AND HANDOUTS]

EVAR vs Open Surgery EVAR vs Open Surgery Advantages of EVAR Level I Evidence § Aortic cross clamping vs continuous perfusion § EVAR1 Trial § Laparotomy vs femoral cut-down • UK trial 1252 patients to open vs EVAR • Totally percutaneous EVAR § OVER Trial § General anesthesia vs regional/local/sedation • VA trial with 881 patients randomized to open vs EVAR § Access complications § ACE Trial § Endoleaks • French trial randomizing 316 patients to open vs EVAR § Durability vs continued surveillance § DREAM Trial • Dutch trial randomizing 351 patients 21 Advances in Heart Disease 12/2/17 22 Advances in Heart Disease 12/2/17 EVAR vs Open Surgery EVAR vs Open Surgery Short Term Mortality (30 days) Summary of randomized trials: Advantages of EVAR § 30d mortality is lower (1.6% vs 4.8%) • Survival advantage greater with higher risk patients § Lower perioperative morbidity (cardiac, pulmonary, stroke) § Less blood loss Long Term Mortality (>4 years) § Faster recovery § Shorter hospital stay (10d vs 4d) 23 Advances in Heart Disease 12/2/17 24 Advances in Heart Disease 12/2/17 6 12/2/17 [ADD PRESENTATION TITLE: INSERT TAB > HEADER & FOOTER > NOTES AND HANDOUTS]

EVAR vs Open Surgery Increasing AAA repair rates Summary of randomized trials: Advantages of Open Paradigm shift due to endovascular options § Long term results for survivors is equivalent • Initial reduction in all-cause mortality is eliminated within 2 years § Higher re-intervention rate § < 50% of patients compliant with recommended surveillance § Higher late aortic complication rate w/ EVAR § Greater cost??? Currently, >80% of AAA repairs are endovascular Ann Surg. 2012 Oct; 256(4): 651–658. 25 Advances in Heart Disease 12/2/17 26 Advances in Heart Disease 12/2/17 Operative Mortality Decreasing Mortality from AAA Correlation to increase in elective repair All Medicare beneficiaries Ann Surg. 2012 Oct; 256(4): 651–658. Ann Surg. 2012 Oct; 256(4): 651–658. 27 Advances in Heart Disease 12/2/17 28 Advances in Heart Disease 12/2/17 7 12/2/17 [ADD PRESENTATION TITLE: INSERT TAB > HEADER & FOOTER > NOTES AND HANDOUTS]

Decreasing Mortality AAA Tips for Successful EVAR Outcomes Correlated to increase in elective repair or decreased smoking? Seal in Normal Aorta: Staying within the IFU 30% of patients treated in the US do not meet IFU for aortic neck criteria Circulation. 2011: 124(10):1097-9 29 Advances in Heart Disease 12/2/17 30 Advances in Heart Disease 12/2/17 Tips for Successful EVAR Outcomes Raising the Seal Zone Seal in Normal Aorta: Staying within the IFU Circulation. 2011 Jun 21;123(24):2848-55. 31 Advances in Heart Disease 12/2/17 32 Advances in Heart Disease 12/2/17 8 12/2/17 [ADD PRESENTATION TITLE: INSERT TAB > HEADER & FOOTER > NOTES AND HANDOUTS]

Raising the Seal Zone Lowering the Seal Zone: Iliac Branch Devices 33 Advances in Heart Disease 12/2/17 34 Advances in Heart Disease 12/2/17 Summary Endovascular Repair of Aortic Disease § Highest risk populations are men, smokers and advanced age Outline • Screen all men over age 65 with smoking history § Abdominal Aortic Aneurysms § Risk stratification for rupture can be refined • Natural History • Treat when risks of rupture exceed risks of repair • Risk Factors § Durability of EVAR is maximized when staying within IFU • Open vs Endovascular Repair § Failed EVAR happens when off IFU and > 3 years after initial • Branch technologies treatment § Thoracic Aortic Aneurysms § Don’t be afraid to raise the seal zone to healthy aorta § Aortic Dissection • Fenestrated devices FDA approved • Endovascular interventions for acute dissections • Branched devices close behind • Indications for subacute interventions 35 Advances in Heart Disease 12/2/17 36 Advances in Heart Disease 12/2/17 9 12/2/17 [ADD PRESENTATION TITLE: INSERT TAB > HEADER & FOOTER > NOTES AND HANDOUTS]

Thoracic Aortic Aneurysms Thoracic Aortic Aneurysms Thoracic Aortic Size and Adverse Events Thoracic Aortic Size and Rupture Risk 37 Advances in Heart Disease 12/2/17 38 Advances in Heart Disease 12/2/17 Thoracic Aortic Aneurysms Thoracic Endovascular Aneurysm Repair (TEVAR) Indications for Repair Available Endografts § Descending Thoracic Aortic Aneurysms (TAA) • Ave. sized adults 6-7 cm • High surgical risk >7 cm • Genetically mediated conditions 5-6 cm ‒ Marfans, Loeys-Dietz, Ehlers-Danlos, Turner or familial TAAD • Rapid expansion • Symptoms 39 Advances in Heart Disease 12/2/17 40 Advances in Heart Disease 12/2/17 10 12/2/17 [ADD PRESENTATION TITLE: INSERT TAB > HEADER & FOOTER > NOTES AND HANDOUTS]