Role of Gender in TEVAR and EVAR results from the GREAT registry

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1 Role of Gender in TEVAR and EVAR results from the GREAT registry Mauro Gargiulo Vascular Surgery University of Bologna - DIMES Policlinico S.Orsola-Malpighi Bologna, Italy mauro.gargiulo2@unibo.it

2 Disclosure Speaker name: Prof Mauro Gargiulo I have the following potential conflicts of interest to report: X 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 GREAT Global Registry Endovascular Aortic Treatment Commercial aortic endovascular products in global markets (US, EU, Australia, New Zealand, and Brazil) Prospective, observational patients GORE (thoracic and abdominal stent-graft) Internet-based data collection (GREAT and 10-12)

4 ESVS Annual Meeting Gender related access complications after TEVAR Lomazzi C, Mascoli C, Cao P, Weaver F, Milner R, Fillinger M, Verhoeven E, Trimarchi S, Gargiulo M - Impact of gender on intra and perioperative EVAR outcome Mascoli C, Lomazzi C, Cao P, Weaver F, Milner R, Fillinger M, Verhoeven E, Trimarchi S, Gargiulo M

5 Gender related access complications after TEVAR The goal of this study was to assess the effect of gender on access complications after Thoracic Endovascular Aortic Repair (TEVAR), using data from GORE GREAT (Global Registry Endovascular Aortic Treatment) Inclusion criteria: all patients with thoracic aortic disease treated with TEVAR Demographics Medical History Case PlanningType of Treatment Follow-up using computed-tomography angiography (CT-A)

6 Gender related access complications after TEVAR Main end-point: prevalence of access complications Second end-points: evaluation of access complications stratified for - gender (M vs. F) - age (<75y vs. >75y) - device size (27-34mm vs mm) Statistical Analysis - Retrospective analysis - Pearson s χ 2 / Fisher-Exact test - Continuous variables: ± DS - Categorical variables: % - P < significant

7 Gender related access complications after TEVAR Aortic Disease N, (%) (total = 963) Descending thoracic aneurysm (including rupture) 336 (34.9) Type B complicated dissection 150 (15.6) Penetrating aortic ulcer 110 (11.4) Type B uncomplicated dissection 105 (10.9) Thoracoabdominal aortic aneurysm (including rupture) 86 (8.9) Traumatic aortic injury 53 (5.5) Graft pseudoaneurysm 40 (4.1) Aortic arch aneurysm (including rupture) 27 (2.8) Type B intramural hematoma 14 (1.4) Other 42 (4.4)

8 Gender related access complications after TEVAR Access Complications Type of complication F, (n) M, (n) P Incisional hematoma 2 0 Pseudoaneurysm 1 1 Arterial dissection 2 1 Arterial thrombosis 3 0 Seroma Wound infection 1 1 Arterial injury 2 0 Bleeding 0 1 Total, (N; %) 11/322 (3.4%) 5/641 (0.8%)

9 Gender related access complications after TEVAR Ø Ø M 2/287 (0.7%) 3/354 (0.8%) F 4/201 (2.0%) 7/121 (5.8%) P < 75y > 75y M 3/456 (0.6%) 2/136 (1.5%) F 6/193 (3.1%) 5/102 (4.9%) P Access Complications vs Graft diameter Access Complications vs Age

10 Gender related access complications after TEVAR Conclusions Access complications are significant higher in women than in men particularly with device of large sheath diameters Younger women showed more frequently access complications compared to those older than 75, reflecting that a women developing atherosclerotic disease in younger age could have a more aggressive disease in all arteries These results suggest a need for more gender dedicated research and therapy, with decreased device delivery size and improvements in EV technology

11 Impact of gender on intra and perioperative EVAR outcome To evaluate Impact of gender on intra & perioperative EVAR outcomes with a currently commercially available stent-graft using GREAT data Retrospective AAA Elective & Acute EVAR GORE Excluder Preoperative, procedural, perioperative data Women vs Men

12 Impact of gender on intra and perioperative EVAR outcome End Points Technical success (TS) Intraoperative / 30-day mortality Hospital stay Perioperative serious adverse events Procedure / device unrelated Procedure / device related Perioperative re-interventions

13 Impact of gender on intra and perioperative EVAR outcome 3309 pts Overall Elective Acute n % n % n % Male Female Overall Elective Acute Male Female p Male Female p Male Female p Age (yrs) < < BSA* (m 2 ) < < *BSA: body surface area Data are expressed as mean

14 Impact of gender on intra and perioperative EVAR outcome Demographics / Comorbidities Overall Elective Acute Male Female p Male Female p Male Female p CAD* (%) < < COPD* (%) < < PVD* (%) < < DCTD* (%) *CAD: coronary artery disease, COPD: cronic obstructive polmonary disease, PVD: periferal vascular disease DCTD: degenerative connective tissue disease;

15 Impact of gender on intra and perioperative EVAR outcome AAA Anatomy AAA diameter (mm) Proximal LZ* diameter (mm) Infrarenal neck angle( ) Overall Elective Acute Male Female p Male Female p Male Female p < < < < < < *LZ: Landing zone;

16 Impact of gender on intra and perioperative EVAR outcome Intraoperative outcome Overall Elective Acute Male Female p Male Female p Male Female p Technical Success (%) day outcome Overall Elective Acute Male Female p Male Female p Male Female p Hospitalization*(%) 4.1± ±5.9 < ± ± ± ± Procedural Survival 0-day death (%) day death (%)

17 Impact of gender on intra and perioperative EVAR outcome 30-day outcome Overall Elective Acute Male Female p Male Female p Male Female p Serious adverse event (%) Proceduredevices unrelated (%) Proceduredevices related (%) REDO (%)

18 Impact of gender on intra and perioperative EVAR outcome Conclusion Gender is not associated with worse EVAR outcomes Technical Success Intra / 30-day mortality Perioperative EVAR-related adverse events Re-interventions Women have greater risk of Longer hospitalization Perioperative EVAR-unrelated adverse events

19 Impact of gender on intra and perioperative EVAR outcome Take-home message EVAR in female gender Safe and effective with currently available endograft Higher attentions in peri-operative period