Endovascular Aneurysm Sealing (EVAS) for Simple and Complex AAAs
Andrew HoldenAuckland, New Zealand
November 16th 2017
The Incidence of Type 1A EL after Nellix EVAS is Low
How to Prevent Them and How Best to Treat Them
AndrewHolden,MBChB,FRANZCR,EBIRDirectorofInterventionalRadiologyAuckland,NewZealand
Nellix:LessonsLearnedfromtheEVASForwardGlobalRegistryandtheFutureRoleofPolymerSealinginAAAManagement
LINC2018
Disclosures and Disclaimers
Andrew Holden MBChB, FRANZCR, EBIR
Clinical Investigator and Advisory Board Member
Endologix Inc.
DisclosureSpeakername: AndrewHolden.
Ihave the following potentialconflicts ofinterest to report:
Consulting
Employment inindustry
Stockholderofahealthcare company
Owner ofahealthcare company
Other – ClinicalInvestigator forELGX
Idonothaveanypotentialconflictofinterest
X
Concept of EndoVascular Aneurysm Sealing
(EVAS) with Nellix®
Different method of aneurysm treatment with “active sac management”
Analogous to open surgical repair with sac ablation
Aim is to prevent endoleak of any type
So how has it performed, what are the lessons learned and what is it’s potential in the future?
2014 2015 2016 20172008-2012 2013
N=30030 Centers(29 EU, 1 NZ)
EnrollmentCompletedSept, 2014
2 YR FU1 YR FU 3 YR FU
N=18029 Centers (26 US, 3 EU)
Enrollment Completed Nov, 2014
PMASubmission
Continued Access
30 DAY FU 1 YR FU
No prospective screening, procedural steps not optimized
Strict IFU compliance, procedural steps evolved
Validating EVAS with Clinical Data
2 YR FU
Spontaneous Resolution of Type II Endoleak
Low Volume 0.1 – 0.4 mL
1 Yr
99.2%
97.0%
IncidencePersistence
Freedom From Type II Endoleak
Freedom From Type II Endoleak
No Secondary Interventions for Type II Endoleak
Freedom From All Persistent Endoleak @ 2 Years
98.1%
AllEndoleak 1.8% (5)(N=277)
TypeIa 0.4%(1)
TypeIb 0.4%(1)
TypeII 0.7%(2)
TypeIII -
TypeUnknown 0.4%(1)
Meanfollow-up25mo (0-35mo)
Similar Positive Results - EVAS FORWARD IDE @ 2 Years
99% FREEDOM FROM
RUPTURE
97%FREEDOM FROM
TYPE II EL
Freedom from Type II Endoleak Freedom from Rupture
Similar Positive Results - EVAS FORWARD IDE @ 2 Years
99% FREEDOM FROM
CARDIOVASCULAR MORTALITY
94%FREEDOM FROM
ALL CAUSE MORTALITY
Freedom from ACM Freedom from CVM
Cross Trial Comparison @ 1 Year
IFU compliance does influence re-intervention
Continued Evolution of Nellix ® EVAS
Despite the excellent results @ 2 years, late complications noted in clinical practice and trials, predominantly after 2 years
These are migration, type IA endoleak and aneurysm sac growth
To mitigate these complications, there has been evolution in the procedure, device and IFU
Continued Evolution of Nellix ® EVAS
1 1 2 2 2
7
33
57
85
2009 2010 2011 2012 2013 2014 2015 2016 2017
Nellix EVAS: A Procedure in Evolution
Patient SELECTION
Proper POSITIONING of the Nellix Device
Establishment of a Durable SEAL
Nellix EVAS: A PROCEDURE in Evolution
• Inflate Nellix balloons to nominal pressure (7 ATM) for AT LEAST 30 seconds
• Leave balloons up during unfurling, pre-fill and polymer – avoids stent displacement and bowing
Nellix EVAS: A PROCEDURE in Evolution
Complete endobag filling is vital to achieve optimum seal
Unfurling of the endobag before deployment of the stents allows optimum endobag conformability
Pre-fill of the endobags after stent deployment with dilute contrast saline allows optimum positioning and calculation of endobag fill volume
Unfurling Contrast-saline Pre-fill Contrast-saline Pre-fill Polymer fill
Nellix EVAS: A DEVICE in Evolution
≥ 10mm seal
Revised Anatomic IFU for Most Predictable Outcomes96% 2 YEAR FREEDOM FROM TYPE IA ENDOLEAK, MIGRATION, OR SAC GROWTH
IFU REFINEMENT AND TYPE IA ENDOLEAK
IFU Impact on Longer Term Data
Single Centre audit of 115 consecutive cases
Auckland Hospital
Minimum follow up 2 years
Mean follow up 3.5 years
Freedom from Type 1A Endoleak
Prospective Evaluation of Revised IFU
1
SiteActivationandEnrollmentStatus(11/10/2017)
Phase 2:StartUpphase:28
Phase3:SiteInitiationScheduled:
Phase 4:SIVcompleted:18(2Sitesdropped) Patients Enrolled(20)
Europe28
(including 2SPNand1SW) 0 15(Active) 11
AsiaPacific12
(including 7AUZsites) 1 (datepending) 1(Active) 9
Site# AccountName/SiteName Country No.ofPatients
Enrolled
Site# AccountName/SiteName Country No.ofPatients
Enrolled
104 AucklandCityHospital NewZealand 9 133 UniversityHospitalKoeln Germany 1
120 ArnhemHospital Netherlands 3 134 TUHMunich Germany 1
123 StElisabethHospitalTilburg Netherlands 2 135 HospitalAugsburg Germany 1
124 StAntoniusHospitalNieuwegein Netherlands 0 136 Klinikum Stuttgart Germany 0
130 UniversityHospitalHeidelberg Germany 0 160 UniversityHospitalRiga Latvia 0
131 Alfried-KruppHospitalEssen Germany 0 139 Marienhospital Osnabrueck Germany 0
110 StGeorge’sLondon UK 0 192 Marienhospital Bonn Germany 2
142 UniversityHospitalValencia Spain 1 143 LaCoruna Spain 0
300 patient trial in Europe and Asia-Pacific
Follow up out to 5 years
FirstGlobalFORWARD2RegistryPatient
Pre 1Month 6Months 1Year
1Year
Up to 90 patients , 28 US sites
Follow up out to 5 years
Vikram Rao
University Hospitals
Cleveland, OH
Chris Healey
Maine Medical
Portland, ME
Jose Trani
Cooper Hospital
Camden, NJ
Homayoun Hashemi
Inova Fairfax
Fairfax, VA
Sajjad Hussain
St. Vincent Hosp.
Indianapolis, IN
Huey McDaniel
Sacred Heart
Pensacola, FL
Satish Muluk
Allegheny General
Pittsburgh, PA
James Benenati
Miami Vascular
Miami, FL
Venkatesh, Ramaiah
Arizona Heart Hospital
Phoenix, AZ
John Lane
VA San Diego
San Diego, CA
Robert Cuff
Spectrum Health
Grand Rapids, MI Lee Kirksey
CCF
Cleveland, OH
Chris Kwolek
Mass General
Boston, MA
William Quinones
UCLA
Los Angeles, CA
James McKinsey
Mount Sinai
New York, NY
Marc Schermerhorn
Beth Israel Deaconess
Boston, MA
Andres Fajardo
Indiana University
Bloomington, IN
Mark Mewissen
Aurora St. Luke's
Milwaukee, WI
Dan Clair
USC Palmetto
Charleston, SC
Nelson Bernardo
Medstar Wash
Washington DC
Fred Stucky
Huntsville Med Center
Huntsville, AL
Manuel Perez-Izquierdo
Florida Hospital
Orlando, FL
Scott Kujath
No Kansas City Hospital
Kansas City, MO
Mark Farber
UNC
Chapel Hill, NC
Stephen Murray
Providence Sacred Heart
Spokane, WA
Brant Ullery
Providence St. Vincent’s
Portland, OR
Caution:TheNellixEndoVascularAneurysmSealingSystemisaninvestigationaldeviceintheUnitedStates,limitedbyfederal(orUnitedStates)lawtoinvestigationaluseonly. MM1828Rev.01
Endovascular Bailout Options Now Approved
Patients who are on the revised IFU:o Part of a clinical trial
o Expect outstanding outcomes in terms of freedom from any endoleak, migration and re-intervention
o Morbidity/mortality benefits of “active aneurysm sac”
Patients with large aortic side branches (high risk of T2EL):
So, Who Do I Treat with Nellix in 2018?
1
SiteActivationandEnrollmentStatus(11/10/2017)
Phase 2:StartUpphase:28
Phase3:SiteInitiationScheduled:
Phase 4:SIVcompleted:18(2Sitesdropped) Patients Enrolled(20)
Europe28
(including 2SPNand1SW) 0 15(Active) 11
AsiaPacific12
(including 7AUZsites) 1 (datepending) 1(Active) 9
Site# AccountName/SiteName Country No.ofPatients
Enrolled
Site# AccountName/SiteName Country No.ofPatients
Enrolled
104 AucklandCityHospital NewZealand 9 133 UniversityHospitalKoeln Germany 1
120 ArnhemHospital Netherlands 3 134 TUHMunich Germany 1
123 StElisabethHospitalTilburg Netherlands 2 135 HospitalAugsburg Germany 1
124 StAntoniusHospitalNieuwegein Netherlands 0 136 Klinikum Stuttgart Germany 0
130 UniversityHospitalHeidelberg Germany 0 160 UniversityHospitalRiga Latvia 0
131 Alfried-KruppHospitalEssen Germany 0 139 Marienhospital Osnabrueck Germany 0
110 StGeorge’sLondon UK 0 192 Marienhospital Bonn Germany 2
142 UniversityHospitalValencia Spain 1 143 LaCoruna Spain 0
Patients who concomitant iliac aneurysm disease:o Short common iliac arteries
o CIA aneurysms with preservation of the internal iliac artery
So, Who Do I Treat with Nellix in 2018?
Patients with failed EVAR and open repair:o Endobag sealing excellent treatment for T1 and T3 endoleaks
o Two tube repair particularly suitable for short body grafts (avoids AUI)
So, Who Do I Treat with Nellix in 2018?
Type 1A Endoleak Repair - ChEVAS
Andrew Holden MD, Auckland NZ
Endurant
So, Who Do I Treat with Nellix in 2018?
Hostile neck anatomy with ChEVAS:o Especially patients declined for FEVAR or need urgent treatment
More imaginative use of parallel grafts:
Conclusions
EVAS is a disruptive technology providing unique “active sac management”
Not surprisingly, there have been challenges in achieving a durable seal but these are now well understood with strategies to avoid and treat complications now developed
Outstanding results should be possible with compliance with the revised IFU – this will be prospectively tested in EVAS FORWARD 2 and EVAS 2 IDE
There are some clear indications for EVAS in 2018
Exciting developments in the future
Endovascular Aneurysm Sealing (EVAS) for Simple and Complex AAAs
Andrew HoldenAuckland, New Zealand
November 16th 2017
The Incidence of Type 1A EL after Nellix EVAS is Low
How to Prevent Them and How Best to Treat Them
AndrewHolden,MBChB,FRANZCR,EBIRDirectorofInterventionalRadiologyAuckland,NewZealand
Nellix:LessonsLearnedfromtheEVASForwardGlobalRegistryandtheFutureRoleofPolymerSealinginAAAManagement
LINC2018