REAL WORLD OUTCOMES WITH ENDOANCHORS...IMPLICATIONS OF ADJUNCTS •553 pts over 8 years (2001-2009)...
Transcript of REAL WORLD OUTCOMES WITH ENDOANCHORS...IMPLICATIONS OF ADJUNCTS •553 pts over 8 years (2001-2009)...
REAL WORLD OUTCOMES WITH ENDOANCHORS
Daniel Clair, MD
Chairman, Department of Surgery
The Four Horsemen of Vulnerable Aorta
Calcification
IrregularityThrombus
Tortuosity
Challenging Proximal Necks
3
Short Neck Tortuous Neck
IMPLICATIONS OF ADJUNCTS
• 553 pts over 8 years (2001-2009)
• Trying to determine causes for reinterventions
• 86 reinterventions (15% at 3 years)
• Intra-operative adjuncts were an independent risk factor for
reinterventions
• HR – 2.62 (1.18-3.76)
More Disclosures
• I think Alexis Carrel had it right we he
introduced the interrupted suture as the
foundation of vascular anastomosis
• I’m biased towards technologies that have
been repeatedly proven for over 100 years
Principles of Open Surgery
• Deep suture bites in normal tissue with permanent suture material• Ligate all tributaries• Flexible fabric
prostheses
Lost in Translation- Different Language
• Device based EVAR fixation & seal
• Distributed (length, angle, shape, disease of neck)
• Not measurable
• Unpredictable
• Unverifiable
• Little control of outcome
• Suture based fixation & seal
• Focused…at site of suture
• Independent of length, angle, shape, disease
• Measurable
• Verifiable – CT exam of adventitia penetration / X-ray
• Increased control of outcome
Endovascular Interrupted Suture System
Heli-FX EndoAnchor Implant System
Six EndoStaples surpasses hand sutured anastomosis fixation
Increase in fixation is proportional to the number of EndoStaples
EndoStaple fixation sometimes outweighs the stent grafts’ integrity
Aortic transectionGraft disruption
Best endograft alone fixation
Average 325% increase
Anastomotic Strength Approximate Ranges
0
20
40
60
80
100
120
140
Endograft Hand Suture Endoanchor
Endograft
= stent graft pledgeted suture
Patients with Proximal Neck lengths < 12mm: 17%
Patients with Proximal Neck lengths < 10mm: 12%
Proximal Neck Zone
Type I Endoleaks*0%
STAPLE 2: Aptus IDE trial42 patients ≤ 15 mm neck length
3
15
24
36
1921
13 12
7
2 3 510152025303540
Cou
nt
0 10 20 30 40 50
100.0%99.5%97.5%90.0%75.0%50.0%25.0%10.0%2.5%0.5%0.0%
maximum
quartilemedianquartile
minimum
5050
48.238.94
2919.9
148.64.9
22
QuantilesMeanStd DevStd Err MeanUpper 95% MeanLower 95% MeanN
22.20258111.0530770.887804523.95642820.448733
155
MomentsM2S AAA Proximal neck Length (mm) - Length between Prox End Diameter and Dist End Diameter
<10N pull-out alone
No Late Term Type 1 Endoleaks
Endoleak Evaluation by Core LabEndoleak Type 30 day F/U
% (n/N)6 mo F/U% (n/N)
1 year F/U% (n/N)
2 year F/U% (n/N)
3 year F/U % (n/N)
4 year F/U % (n/N)
5 year F/U % (n/N)
Type-I0%
(0/149)
0%
(0/141)
0%
(0/132)
0%
(0/107)
0%
(0/81)
0%
(0/64)
0%
(0/62)
• No EndoAnchor Displacement or Fracture in 5yrs F/U
Time from Procedure to Proximal Neck-Related Reintervention
• 3 secondary interventions undertaken in 2 patients to address proximal neck issues
151 145 136 122 106 85 68
0 500 1000 1500 2000
Time in Days
0.0
0.2
0.4
0.6
0.8
1.0
Surviv
al Prob
ability
At Risk
Censored
Product-Limit Survival Estimatewith Number of Subjects at Risk
151 145 136 122 106 85 68
0 500 1000 1500 2000
Time in Days
0.0
0.2
0.4
0.6
0.8
1.0
Surviv
al Prob
ability
At Risk
Censored
Product-Limit Survival Estimatewith Number of Subjects at Risk
Endurant + Heli-FX Short Neck Indication
• <10mm down to 4mm length*
• 19 – 32mm diameters
• ≤ 60˚ infrarenal angulation
• Femoral-only approach
• No renal instrumentation
• Off-the-shelf
• 18 – 20 Fr OD
* Core Lab defined neck length: length over which neck diameter remains within 10% of infrarenal diameter
Short AAA Neck IndicationEndurant™ II, IIs stent graft with Heli-FX™ implants
Neck Length:<10mm down to 4 mm
Neck Length Definition:Length over which the aortic
diameter remains within 10%
of the infrarenal diameter
Proximal Neck Diameter:
19 to 32 mm
Infrarenal Angulation: ≤60 degrees
Infrarenal
Diameter:
25.7 mm
Infrarenal
Angulation:
20.6°
Neck Length:
6.86 mm
Aneurysm
Diameter:
57.7 mm
Avg Neck
Calcium
Thickness:
1.31 mm
Avg Neck
Thrombus
Thickness:
0.85 mm
Endurant + Heli-FX Short Neck Cohort (N=70)
Clinical EvaluationANCHOR Registry Short Neck Cohort
Anchor Registry
Patients
Primary Revision
Endurant
Stent Graft
Other
Devices
70 Endurant Patients with Short Necks
(<10 mm down to 4 mm)
Baseline Anatomical Characteristics per Core Lab
Infrarenal
Diameter:
25.7 mm
Infrarenal
Angulation:
20.6°
Neck Length:
6.86 mm
Aneurysm
Diameter:
57.7 mm
Avg Neck
Calcium
Thickness:
1.31 mm
Avg Neck
Thrombus
Thickness:
0.85 mm
Endurant + Heli-FX Short Neck Cohort (N=70)
Baseline Anatomical Characteristics per Core Lab
93% ASA Class III/IV
26% ASA Class IV
17% Symptomatic presentation
Increased risk of morbidity/mortality
31% Urgent/Emergent cases
Require an off-the-shelf solution
Mean Age: 71.3 Years
Male: 73% Female: 27%
§Technical Success: 88.6% (62/70)
§Procedural Success: 97.1% (68/70)
1 month 12 months
Type 1a Endoleak 6.8% (4/59) 1.9% (1/53)
Endograft Migration N/A 0.0% (0/41)
2nd
Endo Procedure 2.9% (2/70) 4.7% ( 3/64)*
Aneurysm Expansion at 12 months N=54
Decrease 43%
Increase 0%
Stable 57%
Avg. duration
of Procedure (min)
148
Avg. time to implant
(min)
17
Avg. Fluoro time
(min)
35
Avg. number of
EndoAnchor implants
5.5
1-Year Outcomes
* 1.6% (N=1) 2nd Procedure to treat proximal neck
Endurant + Heli-FX Short Neck Cohort (N=70)
Adverse Events through 12 months Patients with EventsEndoAnchor Implant-Related SAE 0/70 0.0%
AAA-Related Mortality 4/68 5.9%
Open Surgical Conversion 0/64 0.0%
Kaplan-Meier Estimates 12 months Freedom from ACM 92.7%
Freedom from ARM 94.3%
Freedom from 2nd
Procedures 95.4%
Freedom from rupture 100%
1-Year Outcomes
Endurant + Heli-FX Short Neck Cohort (N=70)
ENDOANCHORS
• 99 Propensity score matched pairs with and without anchors
• Scoring matched by 19 anatomic measurements
• Outcomes assessed at 2 years
• Freedom from Type Ia endoleak 97.4% vs 94%
• Sac Regression in 81% anchor vs 49% no anchor
• Control subjects with wide neck or neck thrombus had lower
sac shrinkage – No difference for anchor patients
• Each added hostile neck criteria = 23% reduction in sac
shrinkage
In a propensity-matched study design, significantly greater AAA
regression at 2 years post-EVAR
EndoAnchor™+EVAR81.1% ± 9.5%
P-value = 0.01
EVAR48.7% ± 5.9%
Methodology§Pre-EVAR CTs by core lab
§Neck lengths >20 mm
§2 cohorts:
•99pts EVAR
•99pts EVAR+EndoAnchor
§Propensity matching on
19 variables
EndoAnchor & Proximal Seal –Impact on sac regression
Muhs, BE et al. J Vasc Surg. 2017, Article in press
ENDOANCHORS
• ANCHOR Registry
• 100 patients / mean f/u 13 mos
• Primary 73/ revision 27
• 83% hostile neck (>27mm; <10mm; >60 degrees)
• Freedom from Type Ia endoleak 95% (primary) and 77%
(revision)
• Sac shrinkage >5mm in 45% primary and 25% revision
• 1 patient with sac growth
J Vasc Surg. 2014;60:885–892.e2.
HeliFX in Short Angulated Neck -2011
Axial slice at L renal / lowest
HeliFX in Short Angulated Neck
Pre-Op 1 Month 1 Year
• T2 resolved spontaneously
• Massive AAA shrinkage
• Proximal neck “grows”…more proximal apposition
Limitations of Endoanchors
• Poor surgical technique
• Failure to penetrate adventitia
• Less than 4 endoanchors
• Poor distribution
• Smaller targets(short necks) require
more technical expertise
• Tissue integrity - the limit of all
surgical reconstruction
Cross Bar
3
mm
1.0 mm
3.5 mm
Bottom Line• Endoanchors
• Creates “surgical grade” anastomotic strength and
sealing
• Independent of many variables that limit endograft
fixation and seal
• Resist radial expansion - “radial fixation”
• Easy technique
• Widely and rapidly available (1 item on shelf)
• Verifiable on X-ray and CT
• Reimbursed
CONCLUSION
• Adjuncts allow treatment acutely of problem neck
anatomic variable
• Long-term, all patients who “require” adjuncts have
increased need for reintervention
• Anchors may provide benefit in non-hostile necks
by increasing sac shrinkage rates
• Anchors may provide benefit in hostile necks - at
least early – by reducing the impact of these
unfavorable anatomic characteristics