Is EVAS a proper choice in women?
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1 Is EVAS a proper choice in women? CACVS 2018 Jan MM Heyligers, PhD, FEBVS Consultant Vascular Surgeon Elisabeth TweeSteden Hospital Tilburg The Netherlands
2 Disclosures Consultant for Endologix
3 DEVASS =Dutch EVAS Study group St. Antonius Hospital Elisabeth TweeSteden Hospital Rijnstate Hospital Nieuwegein Tilburg Arnhem
4 AAA women vs men Women have a twofold increased frequency of rupture Average aortic size at rupture is 5 mm smaller Higher rate of undiagnosed cardiovascular diseases
5 AAA women vs men Smaller ileofemoral arteries More concomitant iliac aneurysms More challenging aortic neck
6 AAA women vs men Smaller proportion eligible for EVAR Less likely to meet EVAR IFU Longer length of hospital stay after EVAR Higher re-admission rate
7 AAA women vs men More major complications Higher mortality rate So, women and AAA is a challenging combination
8 EndoVascular Aneurysm Sealing System is an investigational device in the United States, limited by federal (or United States) law to investigational use only. The Nellix EndoVascular Aneurysm Sealing System approved to treat infrarenal abdominal aortic aneurysms and is not approved for any other intended use in any geography. What was the primary motive of EVAS? To overcome EVAR issues
9 EVAR has an early survival benefit but an inferior late survival compared with open repair, which needs to be addressed by lifelong surveillance of EVAR and prompt re-intervention if necessary. EndoVascular Aneurysm Sealing System is an investigational device in the United States, limited by federal (or United States) law to investigational use only. The Nellix EndoVascular Aneurysm Sealing System approved to treat infrarenal abdominal aortic aneurysms and is not approved for any other intended use in any geography.
10 EndoVascular Aneurysm Sealing System is an investigational device in the United States, limited by federal (or United States) law to investigational use only. The Nellix EndoVascular Aneurysm Sealing System approved to treat infrarenal abdominal aortic aneurysms and is not approved for any other intended use in any geography. Propensity-score matched cohorts of Medicare beneficiaries undergoing aneurysm repair 39,966 matched pairs of patients Early survival advantage for EVAR but significantly higher late rupture rate N Engl J Med 2015;373:328-38
11 EndoVascular Aneurysm Sealing System is an investigational device in the United States, limited by federal (or United States) law to investigational use only. The Nellix EndoVascular Aneurysm Sealing System approved to treat infrarenal abdominal aortic aneurysms and is not approved for any other intended use in any geography. Rationale behind EVAS Active aneurysm sac management Designed to mitigate endoleak of any type May prevent acute sac thrombosis reduced Post Implant Syndrome Analogous to open surgical repair with sac ablation
12 Baseline characteristics Baseline characteristics Frequency Percent Number Age at procedure* ASA class 2 >2 Missing Hypertension Hyperlipidemia Smoking, or history of smoking in last 10 years Cardiac disease Pulmonary disease Creatinine value* (micromol/l) Diabetes mellitus Known peripheral arterial disease Prior vascular intervention Thrombo-embolic event in history Other concomitant aneurysm Within instructions for use Within instructions for use Symptomatic AAA 0 0
13 Baseline characteristics Baseline characteristics Frequency Percent Number Age at procedure* ASA class 2 >2 Missing Hypertension Hyperlipidemia Smoking, or history of smoking in last 10 years Cardiac disease Pulmonary disease Creatinine value* (micromol/l) Diabetes mellitus Known peripheral arterial disease Prior vascular intervention Thrombo-embolic event in history Other concomitant aneurysm Within instructions for use Within instructions for use
14 Anatomical characteristics Anatomical Median IQR (*percent) characteristics (*frequency) Infrarenal neck diameter Infrarenal neck angle Infrarenal neck length at % diameter increase AAA lumen diameter AAA outer diameter Ratio AAA outer diameter to AAA lumen diameter Infrarenal lumen volume Right CIA lumen diameter Right CIA outer diameter Right EIA diameter 9- *31 * mm Left CIA lumen diameter Left CIA outer diameter Left EIA diameter 9- *32 * mm
15 Anatomical characteristics Anatomical characteristics Infrarenal diameter neck Median IQR (*percent) (*frequency) Infrarenal neck angle Infrarenal neck length at 10% diameter increase AAA lumen diameter AAA outer diameter Ratio AAA outer diameter to AAA lumen diameter Infrarenal lumen volume Right CIA lumen diameter Right CIA outer diameter Right EIA diameter 9- *31 * mm Left CIA lumen diameter Left CIA outer diameter
16 Procedure characteristics Procedure characteristics Number/median Percentage/IQR Anesthesia type General Local Regional Missing Access Cutdown Percutaneous Missing Duration of hospital stay (days) Number of days in ICU Procedure time Blood loss (ml) Polymer volume Secondary fill Total fill volume Polymer fill pressure Procedural complication Endoleak type IA Endoleak type II Endobag rupture Conversion to open repair
17 Procedure characteristics Procedure characteristics Number/median Percentage/IQR Anesthesia type General Local Regional Missing Access Cutdown Percutaneous Missing Duration of hospital stay (days) Number of days in ICU Procedure time Blood loss (ml) Polymer volume Secondary fill Total fill volume Polymer fill pressure Procedural complication Endoleak type IA Endoleak type II
18 Procedure characteristics Procedure characterics Frequency Percent Normal Unilateral Right Left Chimney Distal extension Unilateral Nellix with chimney Nellix for CIAA 2 4.4
19 Procedure characteristics Procedure characterics Frequency Percent Normal Unilateral Right Left Chimney Distal extension Unilateral Nellix with chimney Nellix for CIAA 2 4.4
20 Clinical outcomes
21 Time to reinterven tion (months) Reinterventions 0-12 Mo Indication for reintervention Type of reintervention Within IFU Complication of reintervention 0 Migration preexisting Removal old kissing stent No - stent 0 Thrombus in Covered stent placement No - proximal nellix 0 Brachial artery Venous patch brachial No - occlusion after chimney artery 11 IA Endoleak Conversion to open repair No complicated by hemorrhage distal anastomosis, for which additional stitches were given. Complicated by kidney function deterioration (dialysis needed), atrial fibrillation, rectal bloodloss caused by bowel ischaemia, cardiac fluid overload, respiratory failure and urinary tract infection
22 Time to reinterven tion (months) Reinterventions Mo Indication for reintervention Type of reintervention Within IFU Complication of reintervention 13 Stenosis Relining YES Inguinal hematoma 14 IA Endoleak and migration Relining iliac and Nellix in Nellix Chimney No - 25 IA Endoleak Conversion to open repair No Complicated by pneumonia, and migration successfully treated by antibiotics 25 IA Endoleak Nellix in Nellix Chimney No Renal insufficiency 25 IA Endoleak and migration Conversion to open repair YES Death, Operation itself was uncomplicated, however, postoperatively the patient was in need of much inotropics and died due to limited cardiac reserves
23 Endoleak Time to Type of endoleak Within IFU Reintervention preformed endoleak (months) 10 IA No Conversion to open repair performed 10 IA No None reported 12 IA No Relining iliac + Nellix in Nellix chimney. 23 IA No Conversion to open repair 23 IA No Nellix in Nellix chimney 24 IA YES Conversion to open repair
24 Death characteristics Time to death (months) Within IFU Description cause of death 0: 8 days No Post-operative decreased consciousness. Developed acute kidney insufficiency and unstable haemodynamics. Decrease in neurological functions and pneumonia. Medical treatment was stopped and a comfort treatment was given after which patient died. 1 No Pneunomia/ decompensatio cordis. discharged, died at home. Refused treatment 1 No Unknown 2 No Autopsy : Probable cause of death, pulmonary embolus. Nellix system open. 6 No Patient developed ventricular fibrillation during dialysis treatment 18 No Unknown 25 YES Patient underwent a conversion to open repair for a suspicion of endoleak and flinching. Operation itself was uncomplicated, however, post-operatively the patient was in need of inotropics and died due to limited cardiac reserves
25 Re-interventions 0-12 Months: 4 (8,9%) Months: 5 (11,1%)
26 Conversion to open repair 0-12 Months: 1 (2,2%) Months: 2 (4,4%)
27 Endovascular re-intervention 0-12 Months: 2 (4,4%) = removal iliac stent; covered stent placement Months: 3 (6,7%) = 2 NINA Chimney; relining
28 Endoleak IA 0-12 Months: 3 (6,6%) Months: 3 (6,6%)
29 None reported Endoleak II
30 Death 0-12 Months: 5 (11,1%) of which 1 ARM Months: 2 (4,4%) of which 1 ARM
31 Comparing these data with the EVAS Global data
32 Freedom From All Persistent 2 Years 98.1 % All Endoleak 1.8% (5) (N = 277) Type Ia 0.4% (1) Type Ib 0.4% (1) Type II 0.7% (2) Type III - Type Unknown 0.4% (1) Mean follow-up 25 mo (0-35 mo)
33 Freedom from all persistant endoleaks after 2 years 1 = 97,8%
34 Freedom From Type II Endoleak
35 Freedom From Type II Endoleak No Secondary Interventions for Type II Endoleak
36 Freedom from type II endoleak after 2 years 100%
37 Freedom from Type Ia Endoleak: On and Off- IFU 96.9 % 85.6 % On-IFU Off-IFU p-value = Complex Proximal Neck Anatomy (based on original IFU) Large proximal necks >28mm Thrombus-laden necks
38 Freedom from type Ia Endoleak 6 = 86,7% Reminder: 71,1% outside IFU
39 Freedom from Secondary Intervention: Onand Off-IFU On-IFU 92.2% 80.7% p-value = Off-IFU Reason (N = 277) Endoleak 20 (7.2%) Occlusion 8 (2.9%) Migration 3 (1.1%) Other 13 (4.7%) Mean follow-up 25 months (0-35 ) (based on original IFU)
40 Freedom from Secondary Interventions 9 = 80%
41 Freedom from 2 Years 97.4% 89.1% ARM ACM
42 Freedom from 2 Years ARM: 95,6% ACM: 84,4%
43 Conclusions First cohort that focusses on women after EVAS Majority outside IFU (71,1%) Trend towards more secondary interventions? Trend towards higher mortality rate?
44 Is EVAS a proper choice in women? Results appear to be in concordance with the results of EVAR in women in literature Not many women are within IFU EVAS can be offered to women
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