KHP Who are We? NVR Data

Transcription

1 The VASCULAR Unit

2 KHP Who are We? NVR Data AAA Mortality the answers: Centralise Standardise DO EVAR!! All Aortic Surgery Elective Infra-Renal EVAR

3 What are we trying to do? Fix those AAAs that will shorten lives Minimise operative risk (death AND life-changing complications) Return men to their normal quality of life (trade-off between rapid short-term recovery vs. durability)

4 There are Four Possible outcomes in patients offered elective AAA repair 1: AAA was not going to be the cause of death: a. Patient dies as a consequence of surgery life shortened b. Patient survives surgery Surgery irrelevant 2: AAA was going to cause death: a. Patient dies as a consequence of surgery life shortened b. Patient survives surgery life variably extended

5 EVAR Why bother?

6 Because we can? (The plural of Anecdote is NOT Data!)

7 EVAR The (Minimal) Data

8 So 1. Which aneurysms will kill? UKSAT & ADAM (1996) (Is death by ruptured AAA always so bad?) 2. Which patients will live longer (& for how much longer) if they have successful surgery? CPX testing/age/co-morbidity/! 3. Which is the safest, cheapest & most durable technique? EVAR trials

9 EVAR in the fit The Bottom-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 2013 Jun:100;

10 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: % Only good EVAR is GOOD! 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

11 Learning curves are real! Operative Mortality & Rupture Rate You have to PRACTICE to become GOOD! Systematic review and meta-analysis of 12 years of Endovascular Abdominal Aortic Aneurysm repair. Franks SC et al. Eur J Vasc Endovasc Surg

12 However Is it really that simple? The DURABILITY issue.

13 The EVAR Downside The Durability Issue (EVAR 1 Data)

14 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

15 The Long Term 15 year results EVAR I trial: Reintervention: High for EVAR Occurred throughout the follow-up period Aneurysm-related mortality throughout the follow-up period 0.7 ruptures per 100 person-years The death rate associated with rupture - 67% Greater risk of cancer in the EVAR group

16 Summary - What the literature tells us (Elective AAA Repair) AAA repair confers survival benefit on patients with big AAAs who have otherwise long life expectancies Probably 4 years+ UNCOMPLICATED EVAR is associated with rapid recovery & short hospital stay cf. OSR EVAR is associated with high AAA related re-intervention rates cf. OSR Requires long-term FU The short-term AAA related mortality advantage of EVAR is lost over time

17 The NICE Version. Published 16 th May 18 (Update on 2008/9) Total of 24 Appendices/Evidence Reviews >1250 pages Little more than uncritical version of EVAR2 (Appendix K) Screen Deadlines Open if fit, No EVAR except for RAAA No Complex outside RCTs

18 The NICE Version.

19 EVAR Some Strategic Opinions

20 EVAR is a Team Sport

21 EVAR is a Team Sport The Impact of Complexity

22 Safe Surgery - Standardisation Clinical threats are exacerbated by COMPLEXITY Agree, Publish & Follow Protocols Everything should be ROUTINE Avoidance of ERROR Institution Factors Facilities & Staffing Human Factors The co-pilot is also known as the SAFETY PILOT Reflections on outcome analyses: Introducing the concept of near misses Marc R. de Leval. (2011) Reflections on outcome analyses: Introducing the concept of near misses. Aswan Heart Centre Science & Practice Series: Vol , 12.

23 The Fun Stuff! EVAR The How To

24 The Need to Know Exactly how the device works It s quirks & characteristics (they all have them ) Deployment/Delivery system Deployment sequence Exactly how to plan How to do the operation Safely, Logically & Efficiently (you, the patient, the patient s kidneys)