Hospitals should meet the following criteria in order to provide the required level of care when performing the AVNeo.
1) Surgical Requirements
Healthcare institutions must be actively performing open heart procedures and aortic valve surgeries.
Healthcare institutions must perform more than 20 cases of aortic valve replacement surgeries and/or aortic valve repairs (including aortic root replacement) annually.
Pediatric care institutions must perform more than 50 cases of open heart surgeries (including Off-pump surgery) annually.
Institutions must perform more than 50 transesophageal echocardiographies (TEE) annually.
2) Medical Equipment
The hospital must have transesophageal echocardiography equipment on site to assess the condition of the aortic valve.
The hospital must be able to perform percutaneous cardiopulmonary support, emergency open heart and aortic surgery.
3) Physician Specialty
Requirements will differ by country, but physicians who perform this procedure must be licensed to perform cardiothoracic or cardiovascular surgery in their country of practice.
Physicians must perform more than 20 aortic valve replacement surgeries and/or aortic valve repairs (including aortic root replacement) annually.
4) Internal Review and Informed Consent
Physicians must abide by their healthcare institution’s Internal Review procedures before implementing this procedure.
As with any surgical procedure, physicians should provide thorough patient counseling on the AVNeo procedure, and follow their healthcare institution’s informed consent regulations before proceeding with the AVNeo procedure.
This procedure is performed at approximately 50 medical institutions in Japan and over 1300 cases have been performed (2000+ cases worldwide). The age of the oldest documented patient is 89 years old and the youngest is 5 years old. Over 10 years have passed since the first AVNeo was performed, and the longest follow-up is nearly 10 years (Midterm outcomes after aortic valve neocuspidization with glutaraldehyde-treated autologous pericardium.; J Thorac Cardiovasc Surg. 2018 Jun;155(6):2379-2387. doi: 10.1016/j.jtcvs.2018.01.087. Epub 2018 Feb 15).
Physicians should examine whether an aortic valve is bicuspid or tricuspid using transesophageal echocardiography and transthoracic echocardiography. Assessing ascending aorta size and the degree of calcification in the aortic valve are also important.
There are no patient limitations for this procedure. However, it can be an especially useful surgical technique for patients with smaller aortic valves that are unsupported by prothestic valves.
A paper reporting 54 dialysis patients who underwent AVNeo were found to have no calcification, following echocardiography (Aortic valve reconstruction with autologous pericardium for dialysis patients; Interactive CardioVascular and Thoracic Surgery, Volume 16, Issue 6, 1 June 2013, Pages 738-742, https://doi.org/10.1093/icvts/ivt0333)
It will depend upon each surgeon’s experience and skill level. Cross clamp time may take 30-60 minutes longer than conventional aortic valve replacements. As with any new procedure, cross clamp time will increase in the beginning and gradually decrease with experience.
Four patients in 416 patients needed reoperation because of infective endocarditis. No other causes of reoperation were recorded (Ozaki et al: Aortic Valve Reconstruction Using Autologous Pericardium for Aortic Stenosis; released on line March 30, 2015).
No warfarin is required. Low-dose aspirin is prescribed for 6 months following the AVNeo Procedure.
Theoretically, it should be possible. Safety and effectiveness has not yet been assessed.
In many situations, all three cusps are replaced. However, if the patient has healthy cusps, the surgeon can replace only the diseased cusps.
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Research shows that glutaraldehyde-treated human pericardium is 4 times stronger than untreated human pericardium.
(Yamashita H, et al: Tensile strength of human pericardium treated with glutaraldehyde: Ann Thorac Cardiovasc Surg.2012;18(5):434-7)
There are currently several stabilized bovine pericardial patches available on the market. We have not yet evaluated them for use in AVNeo.