Why EVAR? A review of the literature. (or What did the EVAR trials EVER teach us?)

Transcription

1 Why EVAR? A review of the literature (or What did the EVAR trials EVER teach us?)

2 How did we get here? Parodi Homemade devices initially 2,3 Commercial devices Registries ,6 1 Parodi J C, et al. Transfemoral intraluminal graft implantation for abdominal aortic aneurysms. Ann Vasc Surg. 1991;5: Thompson MM et al Aortomonoiliac endovascular grafting: difficult solutions to difficult aneurysms. J Endovasc Surg 1997; 4: Lawrence-Brown M et al. The Perth endoluminal bifurcated graft system development and early experience. Cardiovasc Surg. 1996;4:706 4 White GH et al A new nonstented balloon-expandable graft for straight or bifurcated endoluminal bypass. J Endovasc Surg. 1994;1: Vallabhaneni SR et al. Lessons learnt from the EUROSTAR registry. Eur J Radiol 2001;1: Thomas S et al. Results from the prospective register of endovascular treatment of aortic aneurysms:. Eur J Vasc Endovasc Surg Jun (6):

3 Now that we can, Should we? DREAM, ACE, EVAR, OVER randomised trials

4 EVAR 1 & Multicentre trial Randomised EVAR 1: Is EVAR be*er than OPEN? Patients fit for open repair Open Surgical Repair or EVAR EVAR 2: Is EVAR be*er than NOTHING? Patients not fit for open repair EVAR or Best Medical Therapy The United Kingdom EVAR trial investigators. Endovascular vs Open Repair of Abdominal Aortic Aneurysm. N Eng J Med. 2010; 362:

5 The Bo?om- Line 30 day or in- hospital all cause mortality ACE DREAM EVAR 1 MEDICARE 1.3 vs 4.7% OR: 0.36 ( ) OVER SwedVasc TOTAL Slather PW et al. Systematic review and meta-analysis of early and late outcomes of open and endovascular aneurysm repair. Br J Surg Jun:100;

6 However Is it really that simple?

7 What are we trying to do? Repair aneurysms that will otherwise shorten lives Lowest risk Most economically NOT Repair all aneurysms Repair the most aneurysms Enrich big pharma

8 4 Possible outcomes in patients offered elective AAA repair 1: AAA was not going to be the cause of death: Patient dies as a consequence of surgery life variably shortened Patient survives surgery Surgery irrelevant 2: AAA was going to cause death: Patient dies as a consequence of surgery life variably shortened Patient survives surgery life variably extended (at a price!) Remember: all interventions profit someone just not necessarily the patient!! 2/3 AAA intact at autopsy

9 So Which aneurysms will kill? UKSAT & ADAM (1996) (Is death by ruptured AAA so bad?) Which patients will live for longer (& for how much longer) if they have successful surgery? CPX testing/age/co-morbidity?? Which is the safest, cheapest & most durable technique? EVAR trials

10 EVAR 1 & Multicentre trial Randomised EVAR 1: Is EVAR be*er than OPEN? Patients fit for open repair Open Surgical Repair or EVAR EVAR 2: Is EVAR be*er than NOTHING? Patients not fit for open repair EVAR or Best Medical Therapy The United Kingdom EVAR trial investigators. Endovascular vs Open Repair of Abdominal Aortic Aneurysm. N Eng J Med. 2010; 362:

11 EVAR 1: Mortality

12 EVAR 1 30 day mortality lower with EVAR 1.6% vs 4.2% Aneurysm related mortality initially lower with EVAR Early benefit for EVAR, but increase in aneurysm related deaths in long term All cause mortality initially lower with EVAR Early benefit for EVAR, but longer term no difference mortality 54% at 8 years in both groups

13 EVAR 2: Mortality

14 EVAR 2 No difference in overall survival between EVAR and best medical therapy Better aneurysm related survival with EVAR (86% vs 64%) Analysis on intention to treat basis (Very high proportion of cross-over)

15 EVAR 1&2: Mortality At 4 years: Approx. 25% of unfit payents survive (& the AAA does not impact life- span) Approx. 75% of fit payents survive

16 A small, but important detail Randomised Trials, Registries and Large Series Early re-intervention at/before 30 days in up to 10% of patients Type 1 endoleak Stent migration Graft thrombosis peri-operative mortality: % Prinssen M et al, DREAM trial group, NEJM 2004 Rutherford RB et al. Semin Vasc Surg Greenhalgh RM et al., EVAR trial partecipants Lancet 2004 Hobo R et al., EUROSTAR collaborators J Vasc Surg 2006

17 The EVAR Downside EVAR 1: Gra` related complicayons & re- intervenyons

18 Paravastu SC et al. Endovascular repair of abdominal aortic aneurysm. Cochrane Database Syst Rev Jan

19 EVAR vs. Open Surgical Repair Epstein D, Greenhalgh RM et al. Long-term cost-effectiveness analysis of endovascular versus open repair for abdominal aortic aneurysm based on four randomized clinical trials. Br J Surg May

20 The obvious limitayons EVAR I & II - Methodology The null hypothesis (It was way beyond 80% & 90% recruitment power and yet extended beyond original plan) Technology Yme warp The comparator groups: I poor UK OPEN results II so` definiyon of unfit WHY? (Financial/Industry/Career drivers?)

21 EVAR I Generalisability? Recruited over 6 years (Sept 99 Aug 04 [or was that June 05?]) AAA > 5.5 cm diameter, anatomically suitable for both EVAR & OPEN PaYents >60 yrs, physiologically suitable for both EVAR & OPEN Screened number: 4799 (Dec 03) Recruited: 1082 then1252 [1429] Similar rayo to OVER the wrong quesyon?

22 The obvious strengths Neither trail confirmed its prejudice! Both are well conducted RCT s

23 LimitaYons of using EVAR I/II trail data in 2015 The trials represent early/naive experience (IFUs, learning curves) Technological advances The management of complicayons has evolved Few data on post abdominal surgery complicayons (laparotomies, hernia repair) No definiyon of fitness for EVAR 2 Failure to adhere to randomisayon for EVAR 2

24 Learning curves are real! OperaYve Mortality & Rupture Rate Systematic review and meta-analysis of 12 years of Endovascular Abdominal Aortic Aneurysm repair. Franks SC et al. Eur J Vasc Endovasc Surg

25 What the literature tells us (ElecYve AAA Repair) AAA repair confers survival benefit on payents who have otherwise long life expectancies Probably 4 years+ UNCOMPLICATED EVAR is associated with rapid recovery & short hospital stay EVAR is associated with high AAA related re- intervenyon rates cf. OSR Requires long- term FU BUT the technology & the surgery seem to be improving