of Open Repair vs. EV AR? Andres Schanzer, MD University of - PDF document

4/4/2019 Evolving AAA Guidelines — SVS, ESVS, NICE: What is the Recommended Balance of Open Repair vs. EV AR? Andres Schanzer, MD University of Massachusetts Medical School April 4 th , 2019 UCSF Vascular Symposium, CA 1 Disclosures • Fenestrated Case Proctoring, Cook Medical 2 1

4/4/2019 Abdominal Aortic Aneurysm ▪ Epidemiology * ▪ 16,000 deaths annually in U.S. ▪ 13 th leading cause of death in U.S. ▪ 10th leading cause of death in men >55 *Dartmouth Atlas of Health Care, 2009. 3 Natural History ▪ Expansion followed by rupture ▪ 0.2-0.4 cm per year expected* *UK Small Aneurysm, Lancet 1998; ADAM, NEJM, 2002. 4 2

4/4/2019 5.5 CENTIMETERS 1998 5 Open Repair ▪ Direct exposure ▪ Transabdominal, retroperitoneal ▪ Proximal and distal control ▪ Prosthetic graft sutured to normal artery 6 3

4/4/2019 Results of Open Repair BUT... Effective and Durable • 5-10% mortality in population- based studies • 15-30% significant morbidity; substantially higher in elderly patients with co-morbidity • Recovery 2-3 months • High risk patients often denied repair 7 AAA Operative Mortality 5.4% in >22,000 pts with non-ruptured AAA J Endovasc Surg 1997;4:232 8 4

4/4/2019 Transformative Moment 1991 9 1991 10 5

4/4/2019 11 Endovascular AAA Repair Exclusion of AAA from the circulation ▪ Device inserted from the groins ▪ Positioned with XRAY guidance ▪ Aneurysm excluded with a covered stent system 12 6

4/4/2019 In the United States, >80% of infrarenal elective repairs of AAA are performed utilizing EVAR * *Lederle et al, NEJM, 2012. 13 *Schanzer et al, JAHA, 2011. 14 7

4/4/2019 EVAR versus Open RCTs DREAM trial EVAR trial I EVAR Open EVAR Open Mean operative time 135 151 182 205 (min) Mean estimated blood loss 394 1654 n/r n/r (mL) Mean blood products 0.09 units 0.44 units 164 mL 896 mL transfused Mean length of intensive 0.67 3 0.7 2.4 care unit stay (days) Mean overall length of 6 13 10.3 15.7 stay (days) Perioperative mortality 1.2 4.6 1.7 4.7 (%) DREAM Trial: NEJM , October, 2004 EVAR Trial: Lancet , September 2004 15 What about long-term outcomes? 16 8

4/4/2019 17 Goals: To evaluate the rate of compliance with imaging follow-up post EVAR and to identify factors associated with being lost to imaging follow-up. 18 9

4/4/2019 Research Design and Methods ▪ Data Sources ▪ Linked data through 2010 from Medicare Inpatient, Outpatient, and Carrier files, to identify all abdominal imaging studies that may have been performed for EVAR follow- up. ▪ N=19,962 19 50% lost to imaging follow-up by 5 years 20 10

4/4/2019 Imaging Follow-Up Compliance Only 37% of those alive 6-8 years post EVAR had an imaging study in last 2 years 21 Compliance with imaging follow-up recommendations after EVAR in the United States is well below the recommended rate. 22 11

4/4/2019 23 “…similar rates of survival…” “…increased rates of reintervention…” 24 12

4/4/2019 25 “…equivalent long -term survival..increased complications, increased reinterventions…” 26 13

4/4/2019 “…beyond 8 years of follow -up open-repair had a significantly lower mortality..increased aneurysm- related mortality in the EVAR group after 8 years was mainly attributable to secondary aneurysm sac rupture.…” 27 28 14

4/4/2019 “…similar rates of survival…” “…our results also indicate that late rupture remains a concern and that endovascular repair does not yet offer a long-term advantage over open repair…” 29 30 15

4/4/2019 “…substantial early survival advantage that gradually decreased over time…” “…late rupture was significantly higher after endovascular repair than after open repair…” 31 What about long-term outcomes? 32 16

4/4/2019 33 34 17

4/4/2019 “…We suggest that elective EVAR be limited to hospitals with…documented mortality and conversion rate to open surgical repair of 2% or less and that perform at least 10 EVAR cases each year. “We…suggest that elective open aneurysm repair be limited to hospitals with a documented mortality of 5% or less and that perform at least 10 open aortic operations of any type each year.…” 35 “…111 evidence -based recommendations on: screening; evaluation; medical, open surgical, and endovascular..…” 36 18

4/4/2019 Evolving AAA Guidelines — SVS, ESVS, NICE: What is the Recommended Balance of Open Repair vs. EV AR? 37 38 19

4/4/2019 39 “…125 evidence - based recommendations on: screening; evaluation; medical, open surgical, and endovascular..…” 40 20

4/4/2019 “…OSR vs EVAR is a never ending story…we are unable to provide a recommendation” 41 Evolving AAA Guidelines — SVS, ESVS, NICE: What is the Recommended Balance of Open Repair vs. EVAR? 42 21

4/4/2019 43 44 22

4/4/2019 “…set up..to reduce variation in…availability and quality…” “Legally recognized…a Non Departmental Public Body…” “…accountable to…Department of Health and Social Care…” “…guidance is officially England- only…” 45 • Latest draft guideline issued in May, 2018 • Left open for comments for 1 month • Intended to update NICE guidance published in February 2009 • The most notable recommendation: unruptured patients should not be offered endovascular repair (EVAR) if open surgical repair is suitable 46 23

4/4/2019 • the controversy continued with several arguments against the proposed NICE recommendations in favor of open repair over endovascular aneurysm repair (EVAR). • A final publication date, which has been repeatedly postponed since November 2018, remains “to be concluded” with no information currently available regarding potential amendments to the final recommendations. 47 Evolving AAA Guidelines — SVS, ESVS, NICE: What is the Recommended Balance of Open Repair vs. EVAR? 48 24

4/4/2019 49 Baseline aortic anatomy is a key determinant of EVAR appropriateness and long term clinical success. 50 25

4/4/2019 39,996 EV AR patients. “ Aneurysm rupture occurred in 5.4% of patients after EVAR…. ” 51 84 patients classified according to neck IFU. Outside IFU (30%): “ Significantly higher migration, device-related complication, and secondary intervention rates. ” 52 26

4/4/2019 565 patients classified according to IFU. Outside IFU (39%): “ …lower freedom from graft - related adverse event ” “ …EVAR treatment outside IFU should be performed cautiously, and perhaps not at all in…candidates for open. 53 238 patients classified according to neck length (>15, 10-15, <10). “ …short necks associated with significantly higher early (12%, 42%, 54%) and late (8%, 54%, 53%) type 1 endoleaks ” 54 27

4/4/2019 258 patients classified according to neck IFU. Outside IFU (63%): “ Significantly higher rates of early type I endoleak and intervention (9% vs. 22%). ” 55 156 consecutive patients classified according to neck IFU. “A conical neck is…single strongest factor associated with proximal failure. ” 56 28

4/4/2019 100 open conversions: “ morbidity 48%, mortality 17% ” “ …The incidence of endograft failure continues to rise…. and can occur even after a decade of successful EVAR repair ” 57 “…31% of patients treated outside the most liberal Instructions For Use (IFU) parameters. ” 58 29

4/4/2019 “5 -year post-EVAR rate of sac enlargement was 41%. ” 59 Anatomy deemed acceptable for EVAR has continued to liberalize and several of these factors are independently associated with aortic aneurysm sac enlargement. 60 30

4/4/2019 • Selection bias • Dated experience with • Lack of outcome data many first generation devices correlating • No device-specific enlargement with clinical events data 61 478 patients classified according to IFU. Outside IFU (59%). Mean follow up 44 months. BJS, October, 2012 62 31

4/4/2019 BJS, October, 2012 63 NORMAL ARTERY NORMAL ARTERY 64 32

4/4/2019 Evolving AAA Guidelines — SVS, ESVS, NICE: What is the Recommended Balance of Open Repair vs. EV AR? • EVAR for appropriate anatomy is an excellent therapy • EVAR for inappropriate anatomy is a step backwards • Despite long-term merging of KM curves, the early mortality benefit of EVAR is real and it is important • I believe the sentiment in the NICE guidelines is a response to poor decision making by physicians 65 Thank You. 66 33