The Fate of Unexpected Events Occurring in Standard EVAR
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1 The Fate of Unexpected Events Occurring in Standard EVAR Andrea Stella Alma Mater Studiorum - University of Bologna
2 Disclosure Speaker name: Prof. Andrea Stella I have the following potential conflicts of interest to report: Consulting Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) I do not have any potential conflict of interest
3 Epidemiology of Aortic Aneurysm Repair in the United States from 2000 to % 74% EVAR OR EVAR A Dua, JVS 2014
4 Epidemiology of Aortic Aneurysm Repair in the United States from 2000 to 2010 In-hospital Mortality Rate OR 4-5% OR EVAR EVAR 1% A Dua, JVS 2014
5 Background EVAR has lower 30-Day Morbidity/Mortality compared with OR but Intraoperative Technical Problems may occur during standard EVAR
6 Adjuvant Procedures Performed During EVAR Does It Influence Outcome? 4631 EVAR 29% EUROSTAR data Registry Center required Adjuvant Procedures (AP) R Hobo, EJVS 2005
7 Adjuvant Procedures Performed During EVAR Does It Influence Outcome? 4631 EVAR 29% EUROSTAR data Registry Center required Adjuvant Procedures (AP) 30-day Mortality Adjunctive Procedure No Adjunctive Procedure 8% 1.5%.001 p R Hobo, EJVS 2005
8 The Impact of Concomitant Procedures during EVAR on Perioperative Outcome 4033 EVAR K Ultee, JVS % required Concomitant Procedures
9 The Impact of Concomitant Procedures during EVAR on Perioperative Outcome 4033 EVAR K Ultee, JVS % required Concomitant Procedures Concomitant Procedures associated with Increased 30-Day Morbidity/Mortality
10 Unexpected Event during EVAR 1. What does it mean? 2. Do it require Adjunctive Procedures? 3. Do it influence EVAR outcomes?
11 Classification Group I Group II Group III Group IV Endoluminal defect High-Flow Endoleak Arterial Coverage Surgical access complication
12 Classification Group I Endoluminal defect Stenosis Iliac Artery Dissection/Rupture Compression Endograft Main Body Endograft Iliac Leg
13 Ø 6 mm
14 Ø 6 mm
15 Ø 6 mm Iliac Artery Rupture
16 Repair with Covered Stent Ø 6 mm Viabahn 7mm
17 Classification Group I Group II Group III Type I Endoleak Group IV Type III Endoleak Endoluminal defect High-Flow Endoleak Arterial Coverage Surgical access complication
18 EL IA
19 Proximal Cuff Deployment
20
21 Classification Group I Endoluminal defect Group II High-Flow Endoleak Group III Arterial Coverage Group IV Hypogastric Artery Coverage Renal Artery Coverage Surgical access complication
22 ** Right Renal Artery Coverage
23 VS Catheter Guide Wire
24
25 Classification Group I Group II Group III Group IV Endoluminal defect High-Flow Endoleak Arterial Coverage Surgical access complication Femoral Artery Thrombosis Femoral Artery Plaque Dissection
26 Unexpected Event during EVAR 1. What does UE mean? 2. Do UE require Adjunctive Procedures? 3. Do UE influence EVAR outcome?
27 Results Standard EVAR (inside the IFU) Unexpected Events 57 - (19%) - Successfully Treated 89%
28 Results Unexpected Events n - 57 % Endoluminal Defect High Flow Endoleak Unplanned Artery Coverage 6 11 Surgical Access Complication 4 7
29 Results Unexpected Events n - 57 % Adjunctive Procedure Endoluminal Defect % High Flow Endoleak % Unplanned Artery Coverage % Surgical Access Complication %
30 Results Adjunctive Procedures Unexpected Events Endoluminal defect High Flow Endoleak Arterial Coverage Surgical Access Complication Adjunctive Procedures PTA stenting Iliac leg PTA stenting Iliac Artery Kissing Stenting/Ballooning No Treated Main-Body Balloning Iliac Leg Extension Proximal Aortic Cuff Conversion to OR Not Treated Renal Artery Stenting Femoral Artery Endoarterectomy Femoral Artery Bypass
31 @ 30-Days Outcomes Unexpected Events (%) Uneventful Cases (%) p Steno-occlusive Event Type I-III Endoleak Hemodialysis Death Re-intervention
32 @ 24-months Outcomes Unexpected Events (%) Uneventful Cases (%) p Type I-III Endoleak 16±10.2 8±3.8.9 Lower Limb Ischemia 20±15 1±1.09 Buttock Claudication 0 10±0.3.6 Hemodialysis Overall Complications 32±15 10±3.9.3
33 @ 24-months Outcomes Unexpected Events (%) Uneventful Cases (%) p Type I-III Endoleak 16±10.2 8±3.8.9 No Significant Differences Lower Limb Ischemia 20±15 1±1.09 Buttock Claudication 0 10±0.3.6 Unexpected Events vs Control Group Hemodialysis Overall Complications 32±15 10±3.9.3
34 @ 24-months Freedom From Re-interventions Unexpected Uneventful Unexpected Uneventful p 70.3 ± 15.4% 95.8 ± 2.5% 0.4 No Significant Differences Unexpected Events vs Control Group
35 @ 24-months Unexpected Events (%) Uneventful Cases (%) p Type I-III Endoleak 16±10.2 8±3.8.9 Lower Limb Ischemia 20±15 1±1.09 Buttock Claudication 0 10±0.3.6 Hemodialysis Overall Complications 32±15 10±3.9.3
36 @ 24-months Sub - group Analysis Late Lower Limb Ischemia Endoluminal Defect Uneventufull Case 11.1 ± 10.5% 1.3 ± 1%.03 p Endoluminal Defect during EVAR is associated with mid-term Lower Limb Ischemia
37 Conclusions Unexpected Events may occur during standard EVAR (19%), needing Adjunctive Procedures in a significant number of cases (89%) Team Performing EVAR should be Skillful in Advanced Endovascular Procedures in order to Correct the so call Unexpected Events
38 Conclusions If Endoluminal Defects appear during EVAR, the Incidence of Late Lower Limb Ischemia is Increased For this reason any defect needs treatment solution during the procedure Strong observation at the end of procedure is mandatory
39 The Fate of Unexpected Events Occurring in Standard EVAR Andrea Stella Alma Mater Studiorum - University of Bologna
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