Aorfix Pythagoras US Clinical Trial:
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1 Overall 1 Year Results from the Aorfix Pythagoras US Clinical Trial: 1 st IDE Study in Highly Angulated Aortic Necks Mark Fillinger MD for the PYTHAGORAS Investigators
2 Disclosure Speaker name: Mark Fillinger... x I have the following potential conflicts of interest to report: x Consulting Employment in industry Shareholder in a healthcare company Owner of a healthcare company Other(s) I do not have any potential conflict of interest
3 Aorfix Device Designed and tested to treat highly angulated aortic necks Highly flexible, soft, conformable device Polyester fabric, Nitinol rings 4 pairs of hooks proximally 8 mm long primary seal zone Commonly placed in a trans renal position
4 Effect of Neck Angle on Seal Zone Inner Curve: 8 mm long neck Centerline: 15 mm long neck In highly angulated aortic necks, the central lumen line (centerline) is not a good indicator of the actual seal zone.
5 U.S. Pythagoras Clinical Trial: First EVAR Trial in aortic neck angles degrees EVAR Arms Roll in Group: Up to 65 EVARs, neck angle <60 Primary Study Group: Up to 150 EVARs, neck angles (and higher) The US trial enrolled 218 patients on intent to treat Control Arms SVS Registry meta analysis of control patients from US EVAR clinical trials (n=323) Concurrently enrolled Open Surgical controls (n=76) for neck angulation and other variables not in SVS
6 Demographics, Comorbidities, Anatomy EVAR and open control patients had similar AAA sac diameter (5.8 cm in each group, p=ns), but the 2 groups differed with regard to 4 factors previously shown to adversely affect outcomes: Age (EVAR 75.4 ±8, vs 69.2 ±7 years, p=0.001), First trial with more female pts in the test group Female (EVAR high angle 35% (51/145) vs 20%, p=0.017) CHF (EVAR 12.6% vs 6.5% p<0.05, SVS controls), First trial with more severe neck angles in the test group Neck angle (EVAR all 72 ± 22, EVAR high angle 83 ± 15, vs Open 48 ±22 degrees, p<0.001) ; EVAR 69% > 60, Open 27% > 60 (p<.05)
7 Interaction between neck angle, gender 30 Angle Distribution By Gender >0 >10 >20 >30 >40 >50 >60 >70 >80 >90 Neck Angle (Degrees) M Count F Count Number of Patients
8 Gender Distribution, EVAR Trials
9 Results: 30 day + Hospital Aortic endografts were successfully implanted in 210/218 cases on intent to treat (all 8 were access related, device not attempted in 4/8). Mortality was 1.8% for the entire cohort (4/218), 2.0% for the angle group (3/153), and 2.8% for the open controls (9/323, p=ns) 30 day outcomes favored the test group for procedure duration, EBL, transfusion, and hospital length of stay (all p<0.05).
10 Freedom from SVS Major Adverse Events (MAEs): Aorfix EVAR Superior to Open Controls * * * * * * * P< for all Aorfix groups vs Open controls
11 EVAR specific Results % Aorfix All Aorfix Aorfix <60 SVS control group Freedom from SVS defined MAE (30 d) N=218 N=151 N=67 N= % 81.5% 92.5% 56.3% Mortality (30 d) 1.8% 2.0% 1.5% 2.8% Sac shrinkage (5mm 1yr) 42% 44% 37% Sac expansion (5mm 1yr) 1.2% 1.8% 0% Type I/III leak (1yr) 1.3% 1.9% 0% Migration (10mm 1yr) 1.2% 1.7% 0% Wire Fracture (1yr) (pre Nitinol change) 6.2% 6.1% 6.4%
12 Effect of Neck Angle on Seal Zone Inner Curve: 8 mm long neck Centerline: 15 mm long neck In highly angulated aortic necks, the central lumen line (centerline) is not a good indicator of the actual seal zone.
13 DHMC Case #2 Pre implant 1 Month post implant 1 Year post implant Images Courtesy of Dr Mark Fillinger, Dartmouth-Hitchcock Medical Center, Lebanon, NH
14 U.S. High Angle Case #1 Pre implant 1 Month post implant 1 Year post implant Images Courtesy of Dr Mark Fillinger, Dartmouth-Hitchcock Medical Center, Lebanon, NH
15 Ability to Treat Highly Angulated Necks 6 month Post Op Images Courtesy of Dr Marc Glickman and Dr Jean Panneton, Sentara Heart Hospital, Norfolk, VA
16 Tips for Greater Success Access: make sure its adequate, do open conduits if you aren t good at endoconduits Put the device at the renal arteries: that is where the neck is stable Watch the renals in angulated necks: use proper c arm gantry angles based on CTA
17 Summary The US Pythagoras Clinical Trial of the Aorfix endograft is the first EVAR Pivotal trial focusing on highly angulated aortic necks (60 90 degrees). Despite significant predictors of worse short and long term outcomes (age, female, CHF, neck angle), MAEs were superior to open repair, and pertinent outcomes similar to EVAR trials with much less severe anatomy. Based on results to date, Aorfix is now CE marked and FDA approved for 0 90 neck angles. As such, it is the only on label alternative to open repair for patients with highly angulated aortic necks.
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