Now that Endoanchors are Approved (and paid for) We have a Durable Solution to Short Necks That s so Easy! David H. Deaton, MD Vascular Surgery / University of South Carolina / Palmetto Health Chief Medical Officer, Syntactx
DISCLOSURE David Deaton, MD Consultant / Advisory Board: Medtronic
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
Let s Start by Agreeing! Aneurysms are a dilating disease ú ú ú ú Radial force(wall tension) accelerates the natural history of the pathologic process Reducing radial force on the artery of a patient prone to aneurysmal degeneration is good (i.e. HTN control) the opposite bad Self-expanding stents were invented/designed to address occlusive disease.not aneurysmal disease Techniques to arrest radial expansion would be a good thing
Let s Keep Agreeing!! (taking getting along to the EXTREME a fantasy?) Cheaper is better if it produces equivalent or better results Faster is often better (i.e. acute aortic patients, unanticipated intraoperative problems, etc.) Easier is better. Less technical facility required.less operator dependence Occluding segmental (intercostal,lumbar) arteries potentially dangerous
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 ú Distributed (length, angle, shape, disease of neck) ú Not measurable ú Unpredictable ú Unverifiable Suture based fixation & seal ú Focused at site of suture ú Independent of length, angle, shape, disease ú Measurable ú Verifiable CT exam of adventitia penetration / X-ray
Ben is RIGHT!! in an EVAR only world Device based EVAR fixation ú Distributed (length, angle, shape, disease of neck) ú Not measurable ú Unpredictable ú Unverifiable So. ú Must use more aorta to make up for deficiency in device based EVAR fixation
Or... We could do what Dr. Carrel and Dr. Debakey suggest.sew the aorta ú Length independent ú Requires Good suture Good surgeon
Heli-FX EndoAnchor Implant System Endovascular Interrupted Suture System
Six EndoStaples surpasses hand sutured anastomosis fixation Increase in fixation is proportional to the number of EndoStaples Average 325% increase EndoStaple fixation sometimes outweighs the stent grafts integrity Best endograft alone fixation Aortic transection Graft disruption
Anastomotic Strength Approximate Ranges 140 120 100 80 60 = stent graft pledgeted Highe suture r Lo wer 40 20 0 En dog raft Hand Suture En doan chor En dog raft
STAPLE 2: Aptus IDE trial 42 patients 15 mm neck length Patients with Proximal Neck lengths < 12mm: 17% Proximal Neck Zone Patients with Proximal Neck lengths < 10mm: 12% 36 40 35 30 3 15 24 19 21 13 12 7 2 3 5 25 20 15 10 Count 0 10 20 30 40 50 <10N pull-out alone Type I Endoleaks* 0%
No Late Term Type 1 Endoleaks Endoleak Evaluation by Core Lab Endoleak 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-I 0% (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 1.0 Product-Limit Survival Estimate with Number of Subjects at Risk Censored 0.8 Survival Probability 0.6 0.4 0.2 0.0 At Risk Censored 151 145 136 122 106 85 68 0 500 1000 1500 2000 Time in Days 3 secondary interventions undertaken in 2 patients to address proximal neck issues
Endurant + Heli-FX Short Neck Indication ú ú ú ú ú ú ú <10mm down to 4mm length* 19 32mm diameters 60 infrarenal angulation Femoral-only approach No renal instrumentation Off-the-shelf 18 20 Fr OD Short AAA Neck Indication Endurant II, IIs stent graft with Heli-FX implants Proximal Neck Diameter: 19 to 32 mm Infrarenal Angulation: 60 degrees Neck Length: <10mm down to 4 mm Neck Length Definition: Length over which the aortic diameter remains within 10% of the infrarenal diameter * Core Lab defined neck length: length over which neck diameter remains within 10% of infrarenal diameter
Endurant + Heli-FX Short Neck Cohort (N=70) Clinical Evaluation ANCHOR Registry Short Neck Cohort Baseline Anatomical Characteristics per Core Lab Endurant Stent Graft Primary Anchor Registry Patients Other Devices Revision 70 Endurant Patients with Short Necks (<10 mm down to 4 mm) Infrarenal Diameter: 25.7 mm Infrarenal Angulation: 20.6 Avg Neck Calcium Thickness: 1.31 mm Neck Length: 6.86 mm Aneurysm Diameter: 57.7 mm Avg Neck Thrombus Thickness: 0.85 mm
Endurant + Heli-FX Short Neck Cohort (N=70) 93% ASA Class III/IV 26% ASA Class IV Baseline Anatomical Characteristics per Core Lab 17% Symptomatic presentation Increased risk of morbidity/mortality 31% Urgent/Emergent cases Require an off-the-shelf solution Male: 73% Female: 27% Mean Age: 71.3 Years Infrarenal Diameter: 25.7 mm Infrarenal Angulation: 20.6 Avg Neck Calcium Thickness: 1.31 mm Neck Length: 6.86 mm Aneurysm Diameter: 57.7 mm Avg Neck Thrombus Thickness: 0.85 mm
1-Year Outcomes Endurant + Heli-FX Short Neck Cohort (N=70) 148 17 35 5.5 Avg. duration of Procedure (min) Avg. time to implant (min) Avg. Fluoro time (min) Avg. number of EndoAnchor implants 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) 2 nd Endo Procedure 2.9% (2/70) 4.7% ( 3/64)* Aneurysm Expansion at 12 months N=54 Increase 0% Decrease 43% Stable 57% * 1.6% (N=1) 2 nd Procedure to treat proximal neck
Endurant + Heli-FX Short Neck Cohort (N=70) Adverse Events through 12 months 1-Year Outcomes Kaplan-Meier Estimates 12 months Freedomfrom ACM 92.7% Freedomfrom ARM 94.3% Freedom from 2 nd Procedures 95.4% Freedom from rupture 100% Patients with Events EndoAnchor Implant-Related SAE 0/70 0.0% AAA-Related Mortality 4/68 5.9% Open Surgical Conversion 0/64 0.0%
EndoAnchor & Proximal Seal Impact on sac regression In a propensity-matched study design, significantly greater AAA regression at 2 years post-evar Methodology Pre-EVAR CTs by core lab Neck lengths >20 mm P-value = 0.01 EndoAnchor +EVAR 81.1% 9.5% 2 cohorts: 99pts EVAR 99pts EVAR+EndoAnchor EVAR 48.7% 5.9% Propensity matching on 19 variables Muhs, BE et al. J Vasc Surg. 2017, Article in press
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
Complications reduced/eliminated by endoanchor Branch occlusions Spinal ischemia
Limitations of Endoanchors Poor surgical technique ú Failure to penetrate adventitia ú Less than 4 endoanchors ú Poor distribution Smaller targets(short necks) require more technical expertise Tissue integrity - the limit of all surgical reconstruction 1.0 mm 3.5 mm 3 mm Cross Bar
HeliFx in Fenestrated EVAR 1:30 SMA 4:30 7:30 10:30 3:00 9:00 Renals Courtesy Dr. Ben Starnes UW / Harbor Medical Center Seattle, WA
Let Them Eat Cake is FEVAR only for the aristocracy? One commercial device in US applicable to small minority of patients Ben treats Physician sponsored IDE ú ú ú Burdensome (a gross understatement) Reimbursement threatened Heavy institutional and infrastructure requirement Bottom Line a luxury afforded to the few
Bottom Line Endoanchors ú Creates surgical grade anastomotic strength and sealing ú Independent of many variables that limit endograft fixation and seal ú Resist radial expansion - radial fixation ú Easy technique ú Widely and rapidly available (1 item on shelf) ú Verifiable on X-ray and CT ú Reimbursed
But If you have ú Fantastic endo skills ú Time to plan and create device ú A physician sponsored IDE ú A financially generous institution ú A patient at low risk for spinal ischemia Then FEVAR totally works!!
Thank You