EVAS - Building the clinical evidence Paul Hayes Vascular Surgeon Cambridge University January, 2016
What do we know about EVAR?
Schanzer et al. Circulation. 2011; 123(24):2848-55. 2
Complications are twice as common with Type 2 EL
Event Type II EL No Type II EL
Aneurysm Sac Enlargement 40% 17%
Secondary Intervention 15% 7%
Rupture 2% 1%
Conversion 6% 3%
Type II Endoleak DOUBLES complications following EVAR
Secondary Interventions Increase Costs
“Efforts aimed at minimizing cost should emphasize technical and device modifications aimed at reducing endoleaks and the need for secondary procedures.”
Event No Yes
Endoleak $5,706 $26,739
Secondary Intervention $3,668 $31,696
Noll RE, et al. J Vasc Surg 2007
EndoVascular Aneurysm Sealing (EVAS) with Nellix
Designed to seal entire aneurysm
Expands endovascular patient eligibility
May overcome issues associated with conventional endografts
Rapidly growing evidence base
6
Pubmed
references
2011 2
2012 1
2013 2
2014 6
2015 30
7
Topic No. Publications
Technology Overview 6 Boeckler, Zentral Chir 2014; Buckley, Semin Vasc Surg 2012; Donayre, Endovasc Today 2009; Holden, Cardiovasc Intervent Radiol, 2014; Holden, J Cardiovasc Surg 2015; van den Ham, Surg Technol Int 2015
EVAS Applicability 1 Karthikesalingam, Eur J Vasc Endovasc Surg 2013
Clinical Outcomes (Gen 1, 2)
3 Donayre, J Vasc Surg 2011; Krievins, Eur J Vas Endovasc Surg 2011; Kisis, Medicina (Kaunas) 2012
Clinical Outcomes (Gen 3)
8 Carpenter, J Vasc Surg 2015; Holden, J Cardiovasc Surg 2015; Alsac, Ann Vasc Surg 2015; Boeckler, J Vasc Surg 2015; Brownrigg, Eur J Vasc Endovasc Surg 2015; Gossetti, J Cardiovasc Surg 2015; Szopinski, Eur J Vasc Endovasc Surg 2015, Zerwes, Vascular 2015
Quality of Life 1 Kisis et al, Medicina (Kaunas) 2012
Imaging Surveillance 5 Holden, J Endovasc Ther 2015; D’Abate, J Endovasc Ther 2015; Karthikesalingam, Endovasc Ther 2015; McWilliams, Endovasc Ther 2015; Ezite, Acta Chir Lat 2013;
Endoleak Management 3 Brownrigg, Eur J Vasc Endovasc Surg 2015; Harvey, JVIR 2016 (accepted); Ameli-Renani, Cardiovasc Intervent Radiol 2015
Iliac Aneurysm 2 Ter Mors, J Endovasc Ther 2015; Krievins, Eur J Vasc Endovasc Ther 2015
Morphology 3 Savlovskis, J Vasc Surg 2015; Boersen, Eur J Vasc Endovasc Surg 2015; Shaikh, J Endovasc Ther 2015
Infection 2 Ferrero, Ann Vasc Surg 2015; Tolenaar, J Endovasc Ther 2015
ChEVAS 9 Boeckler, J Cardiovasc Surg 2014; Dijkstra, J Endovasc Ther 2014; Malkawi, J Endovasc Ther 2014; Niepoth, J Endovasc Ther 2014; Rouer, Ann Vasc Surg 2014; Truijers, J Endovasc Ther 2015; Torella, Cardiovasc Intervent Radiol 2015; Malaj, Ann Vasc Surg 2015; Youssef, JCTS 2016
rEVAS 6 Reijnen, J Endovasc Ther 2015; Truijers, J Endovasc Ther 2015; DeBruin, J Endovasc Ther 2015; Antoniou, J Endovasc Ther 2015; Coppi, J Vasc Interv Radiol 2015; Boeckler, J Cardiovasc Surg 2014
EVAR Revision 3 Van den Ham, J Endovasc Ther 2015; Hughes, J Endovasc Ther 2015; Boeckler, J Cardiovasc Surg 2014
VALIDATING EVAS: Nearly 50 peer-reviewed publications
TREAT MORE PATIENTS
73% 68%
52%
29%
27% 32%
48%
71%
0%
20%
40%
60%
80%
100%
Nellix Medtronic Endurant Zenith Flex Gore Excluder
% Compliant % Not Compliant
Karthikesalingam A, et al. Eur J Vasc Endovasc Surg 2013
More Patients can be Treated On-IFU with Nellix Nellix Suitability Analysis among 776 patients treated previously with other modality
Authors Published Study N Follow-Up
Carpenter et al J Vasc Surg 2015 150 30d
Holden et al (Presented) Veith 2015 277 1yr
Multiple, Physician-Initiated, Real-World Observational Studies
Boeckler et al J Vasc Surg 2015 “Early Nellix Learnings”
Retrospective Review from 7 Centers Treated Oct 2012 through Mar 2014 (before Global Registry)
171 5 mo
Brownrigg et al Eur J Vasc Endovasc
Surg 2015
St. George’s Experience (UK) Largest enrolling site in EVAS Global Registry
Professors Matt Thompson and Ian Loftus 105 30 days
Holden J Cardiovasc Surg
2015 New Zealand, Single Center Study
Professor Andrew Holden, early EVAS pioneer 120 14 mo
Alsac et al Ann Vasc Surg
2015 French, Single Center Study
Prospective Study 20 30d – 1yr
Gossetti et al J Cardiovasc Surg
2015 Italian, Single Center Study 24 30d – 1yr
Szopinski et al Eur J Vasc Endovasc
Surg 2015 Polish, Single Center Study 50 30d – 1yr
Zerwes et al Vascular 2015 German, Single Center Study 50 3 mo
VALIDATING EVAS: Building a Broad Base of Evidence
CONFIDENTIAL
30 Day Results
Carpenter et al, J Vasc Surg 2015
• US IDE Pivotal Trial
• National PI: Jeff Carpenter
• 150 patients at 29 sites: US (26) EU (3)
• Enrollment completed Nov 2014
• Continued access underway
• 30d results presented at SVS 2015
• 1 year results expected Q2 2016
CONFIDENTIAL
Baseline characteristics
Characteristic Mean ± SD (range)
Maximum sac diameter 57.5 ± 6.2 (44, 82)
Non-aneurysmal neck length 31.2 ± 14.0 (10, 103)
Max neck diameter 25.2 ± 3.0 (19, 32)
Aortic Neck Angulation (◦) 29.9 ± 14.2 (3, 59)
CONFIDENTIAL
Procedural data
Parameter Result (N=150)
Device Implant Time 30 min
Fluoroscopy Time 10 min
Total Procedure Time 87 min
Anesthesia Time 187 min
Polymer Fill Volume 75 mL
Time to Hospital Discharge 1.2 days
Results shown as median
CONFIDENTIAL
30 Day Results
100% procedural technical success
Low aneurysm-related mortality (0.7%) and MAEs (2.7%)
No Ruptures, No Conversions
Low incidence of any endoleak
5% Type II - 0.1-0.4 mL (all lumbar); no sac expansion or reintervention
One Type 1a, successfully treated (0.7%)
No Occlusions or Thrombosis
No Device Integrity Issues
Type 2 leak in the IDE trial
14
1yr 30d 6mo
Type 2 Endoleak Resolve with no Sac Expansion or Clinical Sequalae
Device* N MAE 30d Death Endoleaks Secondary
Interventions
Zenith 299 na 1.0% 11% nr
Excluder 235 na 1.3% 22% nr
Endurant 150 4.0% 0% 16% 3.3%
Ovation 161 2.5% 0.6% 44% 1.2%
Aorfix 218 na 1.8% 19% nr
Nellix† 150 2.7% 0.7% 6.0% 0.7%
CONFIDENTIAL
30 Day IDE Comparisons
*30d results for commercially available devices shown per the respective US FDA Summary of Safety and Effectiveness Data (SSED) and peer-reviewed publications of trial results.
na: not applicable. This definition of MAE is different than that of other studies shown. nr: not reported
• Sac size should remain stable or shrink with time
• Shrinkage due to resorption of mural thrombus
• Once mural thrombus has resorbed, no further shrinkage is possible
Surveillance Appearances
Sac Shrinkage noted in 80% cases (n=24) Gossetti et al, JCVS 2015
Pre-op 1mo 6mo 1yr 2yr
EVAS DURABILITY and SAC STABILITY
Sac Stability thru 2 years Courtesy of J Savlovskis, D Krievins
Authors Modalities / Topics
Holden et al Nellix Advisory Board J Endovasc Ther 2015
A Consensus Document CT, US, MR
D’Abate et al St. George’s (UK)
J Endovasc Ther 2015
Ultrasound
Karthikesalingam et al St. George’s (UK)
J Endovasc Ther 2015
CT
McWilliams et al Liverpool, UK
J Endovasc Ther 2015
CT and Ultrasound
Brownrigg et al Eur J Vasc Endovasc Surg 2015
30d Outcomes in 1st 105 patients Includes case example of successful transcatheter
embolization of Type 1a endoleak
IMAGING SURVEILLANCE and ENDOLEAK MANAGEMENT
Lowest ever-reported endoleak rates at 1 year compared to EVAR IDEs
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
EVAS Zenith IDE Endurant IDE Aorfix IDE Excluder IDE Incraft CE Ovation IDE
Type IA, IB Type II Type III/IV Undetermined
0.7%
7.4% 9.8%
17% 17%
37% 39%
*1 Yr results for commercially available devices shown per the respective US FDA Summary of Safety and Effectiveness Data (SSED) and peer-reviewed publications of trial results.
Holden et al, Veith Symposium 2015
Thank you
Top Related