Kentville EVAR Experience Ryan Kelly, Dion Davidson, Ben Heisler 2014 Atlantic Vascular Conference General Surgery R4 Dalhousie University Halifax NS

AAA Background Permanent pathologic dilation of the aorta Affects 5-7% of the population over 60 9000 AAA deaths annually Open approach 30d mortality of 4-12% EVAR repair 30d mortality of 1.2-2% Open: lengthy operative/anesthesia/recovery time, prolonged hospital time including ICU, some patients unfit for open procedure EVAR: More expensive, higher re-intervention rate, no advantage in all cause mortality long-term, committed to more expensive imaging followup Cochrane Systematic Reviews 2014 EVAR1 Lancet 2005;365:2179-86 EUROSTAR Arch Surg 2007;142:33-41 DREAM N Engl J Med 2005;352:2398-405

Retrospective Analysis June 2008 – April 2014 AAA Repairs n = 149 Open n = 97 EVAR n = 52

Objectives Kentville experience vs. early EVAR RCTs Volume - Outcome relationship for EVAR Regional vascular care in Nova Scotia EVAR1 Lancet 2004;364:843–48 RETA Eur J Vasc Endovasc Surg 2001;21:57–64 EUROSTAR Eur J Vasc Endovasc Surg 1999;17:507–16

Results 1987 Dr. Volodos performed the first endovascular thoracic aneurysm repair in Ukraine Dr. Nikolay Volodos

* Surgeon 1 Surgeon 2 Open EVAR 2008 8 3 12 1 2009 10 2 7 5 2010 13 4   Surgeon 1 Surgeon 2 Open EVAR 2008 8 3 12 1 2009 10 2 7 5 2010 13 4 2011 2012 2013 6 2014 55 24 42 28 79 70   Total Open EVAR 20 4 17 7 15 9 12 11 8 2 97 52 149 *

Open EVAR 2008 2009 2010 2011 2012 2013

Characteristic n=52 % Mean Age (years) 75 (SD 7.0) Mean BMI (kg/m^2) Table 1: Preop characteristics among EVAR patients Characteristic n=52 %   Mean Age (years) 75 (SD 7.0) Mean BMI (kg/m^2) 28 (SD 5.3) Female Gender 11 21% Obese 18 35% HTN 34 65% CAD Arrythmia 10 19% CHF 4 8% DLD 21 40% Smoking 33 63% COPD 24 46% Previous Cancer 17 33% Diabetes Renal Failure 6 12% CVD 9 17% GERD 13 25% OSA 5 10% EtOH

Characteristic n=52 % n=531 n=611 n=899 Mean Age (years) 75 (SD 7.0) Table 1: Preop characteristics among EVAR patients EVAR 1 2004 RETA 2001 EUROSTAR 1999 Characteristic n=52 % n=531 n=611 n=899   Mean Age (years) 75 (SD 7.0) 74 (SD 6.0) 72 (SD 7.6) 69 (SD 7.1) Mean BMI (kg/m^2) 28 (SD 5.3) 26 Female Gender 11 21% 49 9% 81 Obese 18 35% 192 HTN 34 65% CAD 234 44% Arrythmia 10 19% CHF 4 8% DLD 21 40% Smoking 33 63% 470 89% COPD 24 46% Previous Cancer 17 33% Diabetes Renal Failure 6 12% CVD 9 17% GERD 13 25% OSA 5 10% EtOH RETA fit vs unfit based on ASA

Characteristic n=52 % Graft Body Vascutek Anaconda 40 77% Cook Zenith Table 2: Intraop characteristics among EVAR patients Characteristic n=52 %   Graft Body Vascutek Anaconda 40 77% Cook Zenith 9 17% Cook Renu 2 4% Medtronic Endurant 1 2% Severity of Disease Mean Size (mm) 60 (SD 6.6) Iliac Aneurysm 4 8% Procedure EVAR only 50 96% Conduits Status Elective (%) 43 83% Urgent (%) 8 15% Rupture (%) Started with cook and then gained experience with anaconda and kept it to get comfortable

Characteristic n=52 % n=531 n=611 n=899 Graft Body Vascutek Anaconda Table 2: Intraop characteristics among EVAR patients EVAR 1 2004 RETA 2001 EUROSTAR 1999 Characteristic n=52 % n=531 n=611 n=899   Graft Body Vascutek Anaconda 40 77% Cook Zenith 9 17% 26 4% Cook Renu 2 18 2% Medtronic Endurant 1 *188 31% Severity of Disease Mean Size (mm) 60 (SD 6.6) 65 (SD 0.9) 61 (SD 1.2) 55 (SD 1) Iliac Aneurysm 4 8% Procedure EVAR only 50 96% Conduits Status Elective (%) 43 83% 502 84% Urgent (%) 8 15% 86 14% Rupture (%) 10 *AneurX, Talent, Medtronic devices Vanguard BS Excluder Gore Talent Word Medical

Unplanned Bypass Required Conversion to Open 4% Death Table 3: Intraop outcomes among EVAR patients Outcome n=52 %   Endoleak 1a 5 10% 1b 3 6% 2 19 37% 1 2% Graft Limb Thrombosis Unplanned Bypass Required Conversion to Open 4% Death ENDOLEAKS: All but one type 1 endoleak corrected in OR. Type 3 was corrected in OR CONVERSIONS: Case 1 Funneled neck. body deployed, migrated, endoleak. Was bleeding around sheaths, conversion to open AAA repair. Cross femoral bypass, R ileofemoral bypass Case 2 Symptomatic, dumbell aneurysm, short neck, small iliacs and distal Ao (14mm), plan for artouni-iliac with fem-fem: Unable to recapture the delivery system; stent migration; Intraop bleed/rupture; conversion to open; cardiac arrest; intraop death

Unplanned Bypass Required 0.05% Conversion to Open 4% 10 32 5% 18 Table 3: Intraop outcomes among EVAR patients EVAR 1 2004 RETA 2001 EUROSTAR 1999 Outcome n=52 % n=531 n=611 n=899   Endoleak 1a 5 10% 39 4.3% 1b 3 6% 29 3.2% 2 19 37% 54 1 2% 0% Graft Limb Thrombosis 13 0.5% Unplanned Bypass Required 0.05% Conversion to Open 4% 10 32 5% 18 Death

Length of Stay Outcome n=51 % Median Length of Stay (days) 3 (SD 6.6) Table 4: In-hospital outcomes among EVAR patients Outcome n=51 %   Median Length of Stay (days) 3 (SD 6.6) <4 day Admit 35 69% >7 day Admit 7 14% Myocardial Infarction 1 2% CHF 3 6% Pneumonia 4 8% Wound Infection UTI Delerium 2 4% GI bleed Ileus AKI Reop Death Length of Stay Reops: -RW 2009 takeback for palmaz extension stent for type 1 endoleak 2009 2012 takeback for bilat femoral endart after subintimal dissection of LEIA 2012 2012 takeback for R SFA thrombus Mention the fact the death occurred at >30 days

Median Length of Stay (days) 3 (SD 6.6) 7 6 <4 day Admit 35 69% Table 4: In-hospital outcomes among EVAR patients EVAR 1 2004 RETA 2001 EUROSTAR 1999 Outcome n=52 % n=531 n=611 n=899   Median Length of Stay (days) 3 (SD 6.6) 7 6 <4 day Admit 35 69% >7 day Admit 14% Myocardial Infarction 1 2% 23 3.8%  36 CHF 3 6% Pneumonia 4 8% 14 2.3% 26  Wound Infection 46 7.5% UTI Delerium 2 4% 10  GI bleed 17   Ileus 5 0.8% AKI 27 4.4% 32  Reop  246 27%  Death 9 1.7% 39 6.4% 29 3.2%

20/52 1 2 3 Outcome n=51 % Endoleak 3 6% Reoperation 9 18% Death 10 1 2 3 20/52 Table 5: Long Term Outcomes Outcome n=51 %   Endoleak 3 6% Reoperation 9 18% Death 10 20% 1 Year Survival 93.5%  3 Year Survival 71.4%  Endoleak: EVAR 2010  2012 R1b embolized and revision of the R graft then… 2014 L1b or 3a required restenting of the L limb. 2: endoleak postop day 10 (but after discharge) new limb… then below Reops: EVAR 2012  10 d later L1b Endoleak (thought to be repaired in OR) needed new limb  Then in 2014 coloaortic fistula = 2014/03/14 left hemicolectomy and irrigation of infected graft secondary to coloaortic fistula; 2014/03/17 reconstruction of common iliac and infrarenal aorta with femoral vein, hypotension upon closure, distal anastamosis; 2014/03/17 take back for hemorrhage and redo of distal anastamosis; 2014/03/18 take back for hemorrhage found to have coagulopathy; 2014/03/20 take back for hemorrhage, splenectomy Deaths were all cause and none known to be attributed to graft failure or rupture

100% 75% 50% 25% 2 4 6 8 EUROSTAR Only 10% unfit 2 4 6 8 EVAR2 N Engl J Med 2010;362:1872-80 EUROSTAR European Journal of Radiology 2001;39:34–41

Discussion 1990 Dr. Parodi performed the first EVAR in Argentina with a balloon expanded Dacron graft mounted on a Palmaz stent Dr. Federico Parodi

Conversion to Open Associated with high mortality 2 Conversions 29% in RETA 50% in Kentville experience 2 Conversions Aneurysm anatomy Graft migration Rupture

Conversion to Open RETA Eur J Vasc Endovasc Surg 2001; 21: 57–64

Conversion to Open RETA Eur J Vasc Endovasc Surg 2001; 21: 57–64

Intraop Technical Challenges 2812 patients One case they didn’t mention: Case with conduit clamp that fell off… EUROSTAR European Journal of Radiology 2001; 39: 34–41

Volume Outcome Relationship Open AAA literature Center v. surgeon volume Institutional support Composite case volume Minimal safe volumes? Effect of caseload on elective aneurysm surgery outcomes have been derived by analysis of patients undergoing open repair Hospital volume is significantly related to elective aneurysm mortality for open repair Higher volume hospitals were more likely to adopt endovascular therapy (44% in high volume hospitals vs. 18% in low volume hospitals) Surgeon volume matters more than insitutional volume J Vasc Surg 2011;53:591-9 Does it matter what a hospital is high volume for? BMJ 2004;328(7442):737–740 J Vasc Surg 2011;53:591-9 J Vasc Surg 2011;54:1208-14 Br J Surgery 2008;95:64-71 Curc Cardiovasc Qual Outcomes 2009;2:624-32

Minimal Safe Volumes London (2007) 13 cases/year/surgeon London (2009) critical >8 cases/year/inst. U Mass (2011) >9 cases/year/surgeon Low Med High Institution <7 7-30 >30 Surgeon < 2 3-9 >9 London 2007 115273 AAA repairs meta analysis with critical volume of 13 cases/ year London 2009 Holt 2005-2007 across UK 11574 AAA repair (20% EVAR) done. Seperated in quintiles <8 <15 up to >100. (2/3 of all EVAR instuitions were <8/year) Large EVAR units also had better open outcomes. U Mass study: 2003-2007 - 14093 cases 60% EVAR shows that surgeon open AAA volume is more predicative then institution (high volume is >9 per year). For EVAR neither institution or surgeon volume influenced mortality J Vasc Surg 2012;55:924-8 J Vasc Surg 2007;46:1287-94 Cardiovasc Intervent Radiol 2009;32:918–922 J Vasc Surg 2011;53:591-9

22 20 18 16 14 12 10 8 6 4 2 10 20 30 40 50 60 70 80 90 100 Number of cases performed by surgeons against the mortality rate for elective AAA (mostly open) repairs The horizontal line represents the cohort mean mortality rate of 5.56% The trend line is a line of best fit, and no statistical inferences have been made from this J Vasc Surg 2007;46:1287-94

High Risk Elective Patients Renal failure (esp with dialysis) Lower extremity ischemia Age > 85 CHF Chronic liver disease Female gender NIH National Medicare database independent predictors of mortality J Vasc Surg. 2009;50(6):1271–9

Lessons Pre-procedural imaging and planning Appropriate graft and patient selection Technical performance of the procedure Post-procedural surveillance Management of EVAR-related complications IFU Zenith Butler.gj@gmail.com

Conclusions VRH provides acceptable EVAR outcomes in a regional vascular surgery unit Volume Outcome relationship for EVAR yet to be clarified Preoperative planning, patient selection, and IFUs are crucial for improved outcomes

Kentville EVAR Experience 2014 Atlantic Vascular Conference Questions?

1987 1990 1993 1999 2000s 1987 Dr. Volodos performed the first endovascular thoracic aneurysm repair in Ukraine 1990 Dr. Parodi performed the first EVAR in Argentina with a balloon expanded Dacron graft mounted on a Palmaz stent 1993 Dr. Lawrence-Brown Royal Perth Hospital group led to the manufacturing of the Cook Zenith graft 1999 FDA approval of two devices for widespread use medtronic and guident devices 2000s Fenestrated and branched grafts