Acute and Midterm Outcomes of the AMDS Arch Remodeling Therapy: - - PowerPoint PPT Presentation

Acute and Midterm Outcomes of the AMDS Arch Remodeling Therapy: DARTS Prospective International Trial

STS 56th Annual Meeting

• Dr. Michael C. Moon

Mazankowski Alberta Heart Institute University of Alberta Edmonton, Alberta, Canada

• Today’s standard-of-care hemiarch repair

successfully addresses the primary entry tear by resection, however, there are significant limitations: 1. Potential creation of a distal anastomotic new entry (DANE) tear(s), allowing for antegrade pulsatile flow (APF) and pressurization of the FL 2. Lack of predictable and reliable visceral and peripheral malperfusion resolution reflected in the high mortality and reinterventions associated with malperfusion.

Background: Today’s Gap

What Causes the Pressurized FL?

• Friability of the dissected aorta,

results in 50-70% a DANE which as a Primary Entry Tear (PET).

• Pressurization of the FL via the

PET (Primary Entry Tear) leads to TL collapse, malperfusion and aortic growth primarily in the region adjacent to the PET.

Distal Anastomotic New Entry (DANE) Malperfusion

*

Negative Remodeling

Bing F, et al. Vascular and Endovascular Surgery 2014;48(3): 239-245 Yasuda S, et al. Circ J doi: 10.1253/circj.CJ-16-0462 Tamura K, et al. Eur J Cardio-Thorac Surg 2017;(52): 867–873 Rylski B, et al. Eur J Cardio-Thorac Surg 2017:(51):1127-1134

AMDS: Mode of Action

• Bridges the treatment gap
• Maximize the benefits of today’s

standard of care without adding complexity

• Supported seal cuff
• Effective sealing of the DANE
• Uncovered stent component
• Allows for uninhibited flow to arch

vessels and other aortic branches

• Enables min. inv. re-interventions if

necessary

The AMDS Hybrid Prosthesis: Biluminal Management

• Minimize development of a

DANE at the distal anastomosis, abolish the APF, decrease the flow into and depressurizing the FL.

• Expansion, maintenance and

pressurization of the TL improves end-organ circulation and manages maplerfusion.

Seal Zone:

Stent Supported Cuff for FL Management

TL Expansion Zone:

Malperfusion Management

DARTS Trial: Objective and Enrollment

• To analyze the safety and performance of the AMDS device at

midterm follow-up in patients presenting with acute DeBakey I aortic dissection undergoing surgical repair.

• The largest prospective, monitored ATAD device trial to date.
• Inclusion Criteria
• Patients 18-80 years
• Acute DeBakey I aortic dissection within 14-days
• Exclusion Criteria
• Extreme hemodynamic compromise requiring CPR
• Marfan, Loeys-Dietz, or Ehlers-Danlos syndrome
• Proximal descending thoracic aortic aneurysm >45mm

Study End-Points

• Primary:

All-cause mortality and SAEs at 30-day SAEs: neurologic dysfunction, device-related adverse

• utcomes
• Secondary:

Malperfusion resolution Aortic remodelling FL response and status All-cause mortality and SAEs at 1 year

Aortic Zone Analysis

Demographics

• From March 2017 to January 2019, a total of 47 patients underwent

emergent surgical repair with AMDS implantation

• One patient was excluded from all analysis due to implantation of an

AMDS in an iatrogenic dissection during a mitral valve repair

Baseline Characteristic % (n=46), Value (IQR) Age (y) 62.5 (48.5, 70.8) Male gender 67.4% (n=31) Malperfusion 56.5% (n=26) Reoperation 4.3% (n=2) Hypertension 63.0% (n=29) Chronic renal failure 13.0% (n=6) COPD 13.0% (n=6) Pre-operative stroke 19.6% (n=9)

Procedure and Hospital Course

Characteristic % (n=46), Value (IQR) Successful device deployment 100% (n=46) Hemiarch repair 97.8% (n=45) Total arch replacement 2.2% (n=1) Aortic root replacement 45.7% (n=21) Median DHCA duration (min) 33.5 (26.0, 41.5) Median cerebral perfusion duration (min) 30.5 (23.0, 37.8) Median AMDS implantation time (min) 3.0 (2.0, 5.0) Median ICU length-of-stay (days) 6.0 (4.0, 12.0) Median hospital length-of-stay (days) 13.0 (8.0, 18.0) Blood transfusion required 60.9% (n=28) Median number of units transfused within 24-hours 3.0 (2.0, 6.0)

Mortality and Serious Adverse Events

Mortality and Serious Adverse Events % (n=46), Value (IQR) Mortality 30-day 1-year Aorta-related Malperfusion-related 13.0% (n=6) 19.6% (n=9) 0% (n=0) 7.7% (2/26) New stroke 30-day 1-year 6.5% (n=3) 6.5% (n=3) Spinal cord ischemia 0% (n=0) Acute renal failure requiring dialysis 10.9% (n=5) Aortic injury associated with device implantation 0% (n=0) Stent fracture 0% (n=0) Distal stent-induced new entry tear 0% (n=0) Device-related reintervention 0% (n=0)

Mortality

Time Post-Treatment (Days) Number of Subjects at Risk 46 30 40 365 37 545 26 730 8 1000 1

0.2 0.4 0.6 0.8 1 200 400 600 800 1000 1200

S (t) Surival Time (t) Days

Freedom from Overall and Aorta-Related Mortality

Overall Mortality Aorta-Related Mortality

Malperfusion Management

• 95.5% (n=63) of vessel malperfusions resolved after AMDS implantation,

without a secondary procedure

• 100% (n=3) of patients presenting with spinal cord ischemia manifesting

as paralysis had complete reversal of their paralysis post-operatively

• Cerebral malperfusion involving the supra-aortic vessels (SAVs) was

anatomically resolved in 85.7% (18/21) of the vessels involved.

Aortic Remodeling

*35 patients have at least 1-year follow-up CT compared to the 1st post-operative CT scan as a baseline **Maximum diameter measured

Aortic Zone A B1 B2 B3 C Change from Baseline** % (N=35*), (n/N) % (N=35*), (n/N) % (N=35*), (n/N) % (N=35*), (n/N) % (N=35*), (n/N) Total Aortic Diameter Decrease Stable Increase 34.3 (12/35) 65.7 (23/35) 0.0 (0/35) 8.6 (3/35) 68.6 (24/35) 22.9 (8/35) 2.9 (1/35) 77.1 (27/35) 20.0 (7/35) 0.0 (0/35) 80.0 (28/35) 20.0 (7/35) 2.9 (1/35) 71.4 (25/35) 25.7 (9/35) TL Diameter Decrease Stable Increase 0.0 (0/35) 11.4 (4/35) 88.6 (31/35) 0.0 (0/35) 14.3 (5/35) 82.9 (29/35) 0.0 (0/35) 31.4 (11/35) 65.7 (23/35) 0.0 (0/35) 22.9 (8/35) 74.3 (26/35) 0.0 (0/35) 51.4 (18/35) 45.7 (16/35) FL Diameter Decrease Stable Increase 88.6 (31/35) 11.4 (4/35) 0.0 (0/35) 88.6 (31/35) 8.6 (3/35) 2.9 (1/35) 40.0 (14/35) 34.3 (12/35) 22.9 (8/35) 54.3 (19/35) 31.4 (11/35) 11.4 (4/35) 25.7 (9/35) 51.4 (18/35) 20.0 (7/35)

False Lumen Response

*39 patients have at least 1 follow-up CT and latest CT scan was used for analysis compared to the 1st post-operative CT scan as a baseline **One dissection ended in distal arch ***Two dissections ended in proximal descending

#Two dissections ended in the mid/distal descending

Aortic Zone A B1 B2 B3 C False Lumen Response % (N=39*), (n/N) % (N=38**), (n/N) (N=36***), (n/N) % (N=34#), (n/N) % (N=34$), (n/N) Obliterated 61.5 (24/39) 26.3 (10/38) 11.1 (4/36) 2.9 (1/34) 2.9 (1/34) Completely thrombosed 12.8 (5/39) 26.3 (10/38) 19.4 (7/36) 20.6 (7/34) 11.8 (4/34) Partially thrombosed 10.3 (4/39) 15.8 (6/38) 36.1 (13/36) 32.4 (11/34) 44.1 (15/34) Patent 15.4 (6/39) 31.6 (12/38) 33.3 (12/36) 44.1 (15/34) 41.2 (14/34)

Occluded SMA Occluded Renal Arteries Bilaterally Patent SMA Patent Renal Arteries Bilaterally

F G

Nearly Occluded Common Carotid Arteries Patent Common Carotid Arteries

D E

Courtesy University Hospital Network, Toronto

Secondary Procedures

• Three patients (6.5%) required malperfusion-related

secondary procedures

• Left renal artery stenting for static malperfusion
• Superior mesenteric artery stenting for static

malperfusion

• Left common carotid artery stenting due to de-novo

dissection of the carotid artery distal to origin of the vessel

• One patient (2.2%) require an aortic growth-related

secondary procedure

• Left common carotid interposition graft, left

subclavian covered stent and coiling of the FL

• No reintervention was directed towards the aortic arch

Secondary Procedures

Time Post-Treatment (Days) Number of Subjects at Risk 46 30 40 365 37 545 26 730 8 1000 1

0.2 0.4 0.6 0.8 1 200 400 600 800 1000 1200

S (t) Surival Time (t) Days

Freedom from Malperfusion-Related and Aorta-Related Reintervention

Malperfusion-Related Aorta-Related

Conclusion

• The DARTS trial results support the use of the AMDS Hybrid

Prosthesis as a safe and effective treatment for acute DeBakey I dissections.

• Effective sealing of the FL at the distal anastomosis with the

AMDS was achieved in 90% of the patients. This seal together with TL expansion leads to elimination of the APF into the FL and improved perfusion of the TL.

• The AMDS complements the standard-of-care procedure and

can improve survival, provide effective and reliable management of malperfusions, induce positive aortic remodeling and reduce the reintervention rates involving the aortic arch.

Questions?