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G Pratesi, MD
Vascular SurgeryPoliclinico Tor Vergata
University of Rome “Tor Vergata”
Predictors for good outcomesin large hole access and closure
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Disclosure
Giovanni Pratesi, M.D.
I have the following potential conflicts of interest to report:
Consulting: Abbott, Cook, Cordis, Medtronic, WL Gore & Associates
Employment in industry
Stockholder of a healthcare company
Owner of a healthcare company
Other(s)
I do not have any potential conflict of interest
✓
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EVAR and percutaneous access:an ideal combination
• Rapid, safe and effective
• Local anesthesia
• Lower risk of wound-related complications (eg, seroma, infection, nerve injury)
• Reduced discomfort for the patient
• Early ambulation, shorter hospitalization
• Totally endovascular, minimally invasive procedure
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Suture mediated closure devices:Prostar XL & Proglide
Needle
Plunger
Collar
Handle
Lever
Marker
Lumen
Body
QuickCut
Proximal
Guide
Distal Guide
Guide
Wire
Exit PortMarker Port
Posterior side of
device
Sheat
h
Foot
(Deployed)
Foot
Link
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Predictors for good outcomes in percutaneous access
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Bechara CF et al., J Vasc Surg 2013
The complications rate during p-evar decreases significantly with increasing operator experience
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1. Preoperative evaluation
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2. Ultrasound guided puncture
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3. Double Proglide technique
Approved for large bore sheath up to 21 Fr
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4. Progressive closure
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5. Post-closure duplex and CT follow-up access sites examination
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Outcomes of percutaneous EVAR:clinical evidences
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Haulon S et al., Eur J Vasc Endovasc Surg 2011
The Prostar XL is an effective and safe device for use in percutaneous closure of large femoral artery sites, comparable to open surgical femoral artery cut-down
Vascular Surgery – University of Rome “Tor Vergata”
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De Souza LR et al., J Vasc Surg 2015
The rate of access related complications (5%) is similar to that reported for PEVAR of infrarenal AAAs using smaller-profile devices.
2009-2014: 102 pts; total percutaneous closure was performed using two Perclosedevices in 170 femoral arteries with ≥20F-diameter sheaths in 163 (96%)
• Techincal success: 95%• 3 thrombosis, 1 retrop
hematoma, 1 pseudoaneurysm• No access-related complications
>30 days
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• 2381 femoral accessbetween 2010 and 2014
• Unselected patients
• Technical Success Rate:96.7% (2303/2381)
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2189 EVARTechnical success: 96.3%
192 TEVAR/f-bEVARTechnical success: 96.9%
TEVAR/f-bEVAR(192/2381)
EVAR(2189/2381)
p
Fr device (mean ± SD) 21.3 ± 2.1 16.7 ± 3.4 .03
Profile > 20 Fr 54 (43.5%) 482 (21.3%) .001
CFA diameter, mm (mean ± SD) 8.4 ± 1.7 8.2 ± 1.4 .15
CFA < 7 mm 9 (7.2%) 163 (7.2%) .54
High CFA bifurcation 2 (1.6%) 64 (2.8%) .32
CFA stenosis >50% 6 (4.8%) 66 (2.9%) .16
J Cardiovasc Surg 2015
Vascular Surgery – University of Rome “Tor Vergata”
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Conversion OR IC 95% p
CFA calcifications 1.65 1.01 – 2.68 < .05
Iliac tortuosity 1.62 .99– 2.65 .052
> 18 Fr 1.16 .69 – 1.97 .57
High CFA bifurcation .94 .22– 3.91 .93
pEVAR Italian Registry:multivariate regression analysis
Pratesi G et al., J Cardiovasc Surg 2015
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How to improve outcomes in pEVAR:tips & tricks
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pEVAR tips & tricks:one Proglide up to 14F femoral access
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pEVAR tips & tricks:sheath downsizing during complex f/bEVAR
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pEVAR: tips & trickspledgets with minor bleeding
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pEVAR: tips & tricksthird Proglide if you are not satisfied
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Expanding pEVAR applicability:toward a 100% percutaneous closure
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Expanding pEVAR applicability:obese patient
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Expanding pEVAR applicability:calcified common femoral arteries
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Conclusions
• Totally percutaneous EVAR/TEVAR using Proglide is a safe and lower invasive treatment
• Technical success is multifactorial and appropriate learning curve is the strongest predictor for good outcomes
• Tips and tricks are effective in additionally increase applicability and effectiveness
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G Pratesi, MD
Vascular SurgeryPoliclinico Tor Vergata
University of Rome “Tor Vergata”
Predictors for good outcomesin large hole access and closure