1st Internal Aortic Annuloplasty Devices
Expanding the Benefits of Valve Repair for Aortic Regurgitation to more US Heart Centers
The HAART Aortic Annuloplasty Devices are expanding the role of aortic valve repair for patients with Aortic Regurgitation. The Devices simplify and standardize aortic valve repair enabling more patients to have access to the benefits of valve repair. Mitral annuloplasty & valve repair transformed the management of Mitral Regurgitation; the HAART Devices are transforming the management of Aortic Regurgitation.
Restoring Normal Aortic Annular Geometry
Aortic Regurgitation is caused by annular dilation – HAART Devices help restore normal geometry
High-resolution CT angiograms of healthy aortic valves were used to map the normal geometry of the aortic annulus. These in-depth studies of the annulus and leaflet coaptation led to the design of the HAART Aortic Annuloplasty Devices. These were the first devices designed to restore normal annular geometry and stabilize it to minimize the risk of future annular dilatation.
High-resolution imaging of healthy valves was the basis for the new design
Designed to restore normal elliptical geometry / commissural orientation and recruit leaflets towards the midline
One Simple Approach: Many forms of Aortic Regurgitation
Trileaflet & Bicuspid Aortic Valves – Aneurysmal & Isolated Aortic Regurgitation
Leverage one standardized technique to address the many causes of aortic regurgitation. Historically, each type of AR was addressed with unique techniques. HAART Annuloplasty Devices provide one approach that broadly applies to trileaflet or bicuspid aortic valves, root aneurysm or isolated leaflet prolapse. The simplicity and the consolidated experience allow surgeons to refine and optimize their repair techniques.
71 year-old Male – NYHA Class III-IV CHG
Mod/Severe Tri-Leaflet Grade 4 AI
5.4 cm Ascending Aortic Aneurysm
3.8cm Aortic Root Diameter
LV Ejection Fraction = 60%
68 year-old Male – NYHA Class II CHG
Severe Grade 4 AI
46-mm Asymmetric Aortic Root
27-mm Aortic Valve Annulus
Bicuspid Aortic Valves
71 year-old Male – NYHA Class III-IV CHG
Mod/Severe Tri-Leaflet Grade 4 AI
5.4 cm Ascending Aortic Aneurysm
3.8cm Aortic Root Diameter
LV Ejection Fraction = 60%
44 yo Male – NYHA Class II CHG
Severe Grade 4 AI
46-mm Asymmetric Aortic Root
27-mm Aortic Valve Annulus
Aortic Valve Repair vs. Replacement & AR Management
Growing Evidence for Repair: Improved Survival & Reduced Cardiac Event Rate
Propensity match studies comparing Aortic Valve Repair vs Aortic Valve Replacement are highlighting the improved survival rates and reduction of cardiac events.
Improved Survival at 8 years (1)
100% vs. 88.9% (p=0.025)
Similar reoperation rates, no significant difference 9.1% vs. 3.3% (p=0.97)
Improved Survival at 8 years (2)
87% vs. 60% (p=0.007)
Université Catholique de Louvain, Belgium
Greater Event-free Survival at 10 years (3)
82% vs. 68% (p=0.024)
University of Ottawa Heart Institute
Large
Global AR Population
1.2MM
US Patients with Aortic Regurgitation (1)
75,000
Diagnosed Annually with Mod. / Severe AR (2)
Severe Symptomatic AR (ssAR) is Undertreated
Only
26%
of ssAR patients had SAVR within 1 year (2)
Severe Symptomatic Aortic Regurgitation is a Class I Recommendation for SAVR
ssAR w/o treatment
at 1 year has
2.7x Mortality rate
Never Forget Aortic Regurgitation Webinar Series
Led by Dr. Hector Michelena
Aortic Regurgitation is often under-diagnosed & under-treated. This webinar series brings needed focus on the advances in Aortic Regurgitation Management. The three part series addresses:
- Updates to AHA/ACC Guidelines & data suggesting the need for earlier AR intervention
- Leak Detection: Multimodality imaging and 4D Flow vs. Echo
- Bicuspid Aortic Valve & the Expanding Role of Aortic Valve repair
Clinical Evidence
Follow-up >7 years and growing
Globally, over 1,400 procedures have been performed with the HAART Aortic Annuloplasty Devices. The clinical evidence on the HAART devices continues to grow with 40+ peer-reviewed publications and maximum follow-up out to 7+ years.
- Crooke PS, et al. Design Characteristics of a Three-Dimensional Geometric Aortic Valve Annuloplasty Ring. Innovations 2013;8:364-370.
1) Malaisrie SC, et al. Valve-sparing versus valve-replacing aortic root replacement in patients with aortic root aneurysm. J Card Surg. 2022 Apr 5.
2) de Meester C, et al. Valve repair improves the outcome of surgery for chronic severe aortic regurgitation: a propensity score analysis. J Thorac Cardiovasc Surg. 2014 Nov;148 (5): 1913-20.
3) Jabagi H, et al. Aortic Valve Repair Decreases Risks of VRE in AI at 10 Years: A Propensity Score-Matched Analysis. Ann ThoracSurg. 2021 Jul 3:S0003-4975(21)01165-6.
