Aortic Diseases Elliot L. Chaikof, MD, PhD Roberta and Stephen R. Weiner Department of Surgery Beth Israel Deaconess Medical Center Harvard Medical School Clinical Practice Council of the SVS AAA Practice Guidelines Writing Committee Elliot L. Chaikof, MD, PhD David C. Brewster, MD Ronald L. Dalman, MD Michel S. Makaroun, MD Karl A. Illig, MD Gregorio A. Sicard, MD Carlos H. Timaran, MD Gilbert R. Upchurch, Jr., MD Frank J. Veith, MD Prevalence of Aortic Aneurysm • Prevalence of AAA among women is slowly increasing, with women now representing 1/3 of patients presenting with rupture. Circulation 2011; 124:1118-1123 AAA (> 3 cm) in 1.7% of 26,000 65 y/o men screened Annual Open AAA and EVAR in US: 1993 - 2005 45000 40000 35000 30000 TOTAL OPEN 25000 20000 15000 EVAR 10000 5000 0 1993 1995 1997 1999 2001 Schermerhorn M et al. JVS 2009; 49(3):543-50 2003 2005 Lancet 2002; 360: 1531–39 Community-based screening reduces mortality from an AAA in men aged 65–79 years, but are not cost effective in women in whom the prevalence of AAAs is lower Jonk YC, Kane RL, Lederle FA, MacDonald R, Cutting AH, Wilt TJ. Int J Technol Assess Health Care 2007;23:205-15. All Markov modeling studies published to date have predicted higher lifetime costs associated with EVAR SVS Clinical Decisions for Patients with Aortic Disease 1. Comparative effectiveness of OR vs EVAR • • • Ascending and arch aortic aneurysms Thoracoabdominal aneurysms Acute or Chronic Type B aortic dissections 2. Optimal treatment of AAA between 5 – 6 cm 3. Optimal surveillance regimens after EVAR Bending the cost curve $7,300 per capita in US in 2008 • Selective screening and surveillance • Selective repair • Reducing costs for EVAR or OSR Reduce Reduce Per Capita Costs Unnecessary Interventions Screening Abdominal Aortic Aneurysms Very Efficiently (SAAAVE) Act 2006 •Who A one-time qualifiesAAA for the US Medicare screening screening? as part of a InWelcome 2009, 20,000 Medicare patients were to Medicare physical exam. •screened Men who out haveof smoked sometime during their life 200,000 in the US at risk •• The must be aconducted duringofthe first Menphysical and women with family history AAA 12 months of enrollment. Risk Factors for Aortic Aneurysms • Smoking is the single strongest risk factor for the development of AAA • AAA risk increases by 40% every 5 years after the age of 65 years • Men are at much higher risk of AAA than women • Central obesity increases risk • A family history of AAA doubles the risk of AAA Risk factors for aortic aneurysms do not correlate with many risk factors for atherosclerosis • Hypertension is weakly associated with AAA • The relationship between hyperlipidemia and AAA is complex • Diabetes is protective of AAA formation Nat. Genet. 40, 217–224 (2008) Nat. Genet. 42, 692–697 (2010) Who do we screen? Ann Intern Med. 2005;142:203-211 British Medical J 2004; 329: 1259-1262 • Selective screening of high risk groups • Risk factor scores J Vasc Surg 2005;41:741-51 Who should be enrolled in continued AAA Surveillance Should we follow aneurysms less than 4 cm in diameter given their low risk of rupture? Br J Surg 90: 821-6, 2003 • 12 yr analysis of 1121 AAA in 65 yr-old men • 2.6 cm < AAA < 2.9 cm • 14% > 5.4 cm at 10 years • 3.5 cm < AAA < 3.9 cm • 10.5% > 5.4 cm and 1.4% had ruptured at 2 years Biomarkers for AAA Disease Management of the Small AAA Immediate EVAR vs. Surveillance 4.0 cm < AAA < 5.4 cm Has the balance of risk and benefit changed with EVAR? CAESAR Small AAA Trial: Immediate EVAR vs. Surveillance 360 patients 180 pts Surveillance 180 pts EVAR Mean f/u 26 mos. 236 pts EVAR 15 pts OSR 102 pts Surv. • Aneurysm-related mortality (0.6% vs 0.6%; p=1) • 30-day mortality (1% vs 0%; p=1) • Aneurysm rupture (0% vs 0.2%; p=0.2) CAESAR Trial at 3 Years: Immediate EVAR vs. Surveillance • 76/180 (42%) patients in the surveillance group underwent repair • The probability of receiving AAA repair over a 3-yr study interval was • > 50% > 4.5 cm • 32/180 (18%) underwent open surgery because of loss of EVAR suitability Crossover Effect in Trials of AAA Treatment vs Observation • UK SAT: 62% (327/527) crossed over during a 5-year follow-up period. • ADAM: 62% (351/567) crossed over during a 5-year follow-up period. • Crossovers related to subjective ‘symptoms’ or patient preference. Patient Perspective with a Small AAA The question is not… “if” EVAR should be performed but “when”… Pharmacological Strategies to Prevent AAA Expansion or Rupture • b-blockers and ACE inhibitors The Non-Invasive Treatment of Abdominal Aortic • Tetracycline Aneurysmand Clinical macrolide Trial antibiotics (N-TA3CT) • Anti-platelet agents 248 patients NIH Funded Trial - Randomize • Statins Determine if doxycycline (100 mg bid) will inhibit by 40% the increase in diameter of small AAA Surg 2002; 36: 1-12 (3.5-5.0 cm in men, 3.5-4.5 cmJ Vasc in women) over a 24-month period. Clinical Trials to Assess Risk and the Benefit of Medical Intervention • Inflammation and Risk Prediction in Patients With AAA (Vanderbilt, PI: U. Sampson ) – predicting risk using FDG-PET with CT • Study on Anti-inflammatory Effect of Antihypertensive Treatment in Patients With Small AAA's and Mild Hypertension (VU University, PI: Jan D. Blankensteijn) – Aliskiren and Amlodipine Clinical Trials to Assess Risk and the Benefit of Medical Intervention • Evaluation of Effect of ACE Inhibitors (perindopril) on Small Aneurysm Growth Rate – (Imperial College, PI: Neil R Poulter) • Feasibility Study of Exercise Training for AAA Disease – (Sheffield Teaching Hospitals/University of Hull) Morbidity of Open and EVAR AAA Repairs: 1995 - 2008 Schermerhorn M et al. NEJM 2008; 358:464-474. Risk Models for Elective EVAR or Open AAA Repair • Risk models that incorporate physiological and anatomical data (APACHE II, GAS, POSSUM). • Improved tools to assess likelihood of aneurysm expansion and rupture risk among high risk patients. • Interventions to reduce postoperative morbidity (e.g. cardiac, pulmonary, renal) N Engl J Med 2007;357:2277-84 Doubling in less than a decade Number of CT scans/yr in US Lifetime Cancer Risk/Abdominal CT J Vasc Surg 2009;49:60-5 • 406 paired CT/US examinations • Sensitivity for Duplex ultrasound was 86% • All clinically significant endoleaks demonstrated on CTA were also detected on Duplex ultrasound US vs CTA for Surveillance After EVAR • Contrast Ultrasound in the Surveillance of EVAR (n = 160) – Ottawa Hospital Research Institute, PI: Sudhir Nagpal • CT Versus Color Duplex US for Surveillance of EVAR. A Prospective Multicenter Study (n = 1000) – Centre Hospitalier Universitaire de Nice, PI: Hassen-Khofja Reda