LivaNova Bicarbon Aortic Valves gets CE Mark for Lower Target INR in Low-Risk Patient

[DJM 18]

[h=1]It seems now as if On-X is not alone in positioning their aortic mechanical valve with the potential to have a lower target INR in low risk patients.

LivaNova Bicarbon Aortic Valves Receive CE Mark for Expanded Use Labeling with Lower-Dose Blood Thinners in Low-Risk Patients[/h] https://www.businesswire.com/news/h...vaNova-Bicarbon-Aortic-Valves-Receive-CE-Mark


LONDON--(BUSINESS WIRE)--LivaNova PLC (NASDAQ:LIVN) (“LivaNova” or the “Company”), a market-leading medical technology company, has received CE Mark approval for its Bicarbon® aortic valves for use with low-dose anticoagulant therapy. The expanded CE labeling means that a lower international normalized ratio (INR), the standardized index used to measure blood coagulability, can be targeted following Bicarbon aortic valve implantation in low-risk1 patients undergoing single bileaflet mechanical aortic valve replacement.

“When choosing a mechanical valve, patients look for a treatment option which lasts for life. The lower INR range approval for LivaNova Bicarbon Aortic Valves means patients now have a greater choice when selecting a mechanical prosthesis, with the freedom to enjoy a more active, confident lifestyle,” said Alistair Simpson, General Manager of LivaNova’s Cardiac Surgery business franchise.

Patients with mechanical heart valves are at risk of blood clot formation (thrombosis and embolism). These patients are placed on lifelong anticoagulant therapy, which can cause side effects, including an increased bleeding risk. After implanting LivaNova Bicarbon aortic heart valves in patients at low risk for thromboembolic events, physicians can now work with a lower-range level of anticoagulant therapy (INR range of 1.5 to 2.5 with 1.9 median target), potentially reducing the risk of bleeding with no increased risk of blood clots.

In more than 25 years of clinical use and up to 17 years of published follow-up2, the Bicarbon family of mechanical valves has shown evidence of a very low incidence of thrombogenicity.

The expanded indication for the Company’s Bicarbon family of aortic heart valves is based on this evidence and the results from the LOWERING-IT trial where patients saw a 60 percent reduction in risk of bleeding3.

“Our experience from the LOWERING-IT trial with nearly 300 patients implanted with Bicarbon aortic valves maintained with an INR close to 1.9, with a median follow-up of over five years was presented at the American Heart Association 2017 meeting in Anaheim, California,” said study lead author Michele Torella, M.D., Ph.D., Department of Cardio-Thoracic and Respiratory Sciences, Monaldi Hospital, Second University of Naples, Naples, Italy. “Our study indicated that the proposed low-INR range between 1.5 and 2.5 (with 1.9 median target) is safe and feasible in low-risk patients after isolated aortic valve replacement with LivaNova’s Bicarbon prosthesis, resulting in similar thrombotic events and in a significant reduction of bleeding occurrence when compared to the conventional anticoagulation regimen.”


1. INR range 1.5-2.5 in patients at low risk for thromboembolic events undergoing single mechanical aortic valve replacement
2. Single center experience with the Sorin Bicarbon prosthesis: A 17-year clinical follow-up. Celiento et al. - J Thorac Cardiovasc Surg 2014;148:2039-44
3. LOWERing the intensity of oral anticoagulant Therapy in patients with bileaflet mechanical aortic valve replacement: Results from the “LOWERING-IT” Trial. Torella et al. - Am Heart J 2010;160:171-8

 

[jwinter]

Good post. The future of mechanical valve replacement continues to look better and better.

I am sure there will be naysayers here but I believe in the future there will be mechanical valves needing very little coagulation therapy.

My On-X installed November 2016 was done and target INR was 2.5 to 3.5(surgical assistant said 2-3). I say was because I have since received information that target has been changed to 1.5. I have since visited with the surgeon that was supposed to do my On-X and he assured me 1.5 is a good number for this valve.. Have a check up coming with cardio in near future and will discuss.

I really hope this is part of our future.

 

[Rob88]

Very interesting. I have a carbomedics carboseal and am keeping my INR in the range of 2.5-3.5

 

[Ed Dantes]

It seems now as if On-X is not alone in positioning their aortic mechanical valve with the potential to have a lower target INR in low risk patients.
DJM 18

Is this valve itself FDA approved for use in the USA? (regardless of INR recommendations).
"In more than 25 years of clinical use and up to 17 years of published follow-up2, the Bicarbon family of mechanical valves has shown evidence of a very low incidence of thrombogenicity."
If this valve is not available for use in the US after 25 years, why not? It sounds great!

I agree jwinter, the ideal valve has infinite (pt lifetime) durability, lowest resistance to flow through it, and the perfect level of anticoagulant in which the protective effect that anticoagulants afford everyone outweigh the negative effects due to the low INR level.

 

[DougWyndham]

Sounds good - especially for lower INR targets

 

[Nocturne]

Wait, wait... So people in the USA can't get this thing? After it's been around for a quarter of a century? I wonder what part of the swamp caused that - they didn't genuflect before the FDA quickly enough, or line the right pockets? Jesus.