UPMC Leads Nation in Innovative Ozaki Procedure Cases
June 1, 2021
For patients with aortic valve disease, an aortic valve replacement (AVR) has long been the standard of surgical care. While traditional approaches to AVR have demonstrated successful outcomes, there are some potential drawbacks to animal and prosthetic valves.
Danny Chu, MD, cardiothoracic surgeon at the UPMC Heart and Vascular Institute and director of the Center for the Ozaki Procedure, shares that in some instances, patients react negatively or altogether reject foreign valves. Furthermore, some patients express uneasiness with a foreign body implantation or animal tissue implantation.
Clinical Approach
An alternate approach to treating aortic valve disease is the Ozaki procedure. This innovative treatment replaces the diseased valve with one constructed from autologous tissue.
During the procedure, the surgeon harvests a portion of the pericardium and places the patient on a cardiopulmonary bypass machine, then removes the diseased aortic valve. After adding glutaraldehyde to the pericardium tissue to strengthen it, the surgical team constructs a new valve. The surgeon uses stitches to create three aortic valve leaflets for the new valve. Then, the surgeon places the new valve into the patient’s heart and completes the procedure.
“We’ll see the patient in clinic about a month or so after operation,” Dr. Chu says. “We’ll get an ultrasound to look at the valve. After that, we’ll still want the patient to get an ultrasound once a year to look at this valve.”
Outcomes
More than 10 years of data on the Ozaki procedure show no major long-term complications from the procedure. Dr. Chu says data show a 95% freedom from re-operation. In addition, the need for a permanent pacemaker after the procedure is nearly zero for patients who undergo the Ozaki procedure, compared to a 5% risk of other surgeries (Ozaki et. al, 2018).
“This is not an experimental procedure,” Dr. Chu says. “It is an FDA-approved procedure with published excellent long-term outcomes.”
The Ozaki Procedure vs. Animal Tissue Valves
Valves constructed from autologous pericardium typically last longer than animal tissue valves, Dr. Chu says, but more data is needed to determine exactly how long they last.
With animal tissue valves, there is also a chance your body will react negatively to the foreign tissue. The Ozaki procedure doesn’t pose the same risk because the valve comes from autologous tissue.
“The advantage of this is patients have better long-term outcomes with better flow hemodynamics than your standard animal tissue valve,” Dr. Chu says.
The Ozaki Procedure vs. Mechanical Valves
It is likely that a valve created during the Ozaki procedure will not last as long as a mechanical valve. However, patients with mechanical valves need to take warfarin for the remainder of their lives. Warfarin carries a cumulative risk of 1% per year of major bleeding and/or stroke complications. Other than aspirin in the months following the Ozaki procedure, long-term blood thinners are not typically required postoperative.
In addition, valves created from the autologous pericardium more closely resemble the natural aortic valve, which lessens the risk of hemodynamic issues with your new valve.
“The best flow is without resistance,” Dr. Chu says. “The Ozaki procedure has really nice flow dynamics compared to other valves.”
Mechanical valves can also be costly for the health care system compared to the Ozaki procedure.
The Ozaki Procedure at UPMC
UPMC is the only health care provider in western Pennsylvania to offer the Ozaki procedure. Experts at the Center for the Ozaki Procedure, a Center for Excellence within the UPMC Center for Heart Valve Disease, train surgeons from across the world on this innovative technique on a regular basis.
Our team of experts have several years of clinical experience with the Ozaki procedure, and have the highest volume of adult Ozaki procedures in the nation. Dr. Chu hopes to see the Ozaki procedure become a more standard approach for valve replacement, compared to other tissue valves.
“The data speaks for itself,” Dr. Chu says. “The data for this is better than nearly all of the tissue valves out there. This should be a really attractive option for many patients.”
For more information about the UPMC Heart and Vascular Institute, or to make a referral, please call UPMC’s 24-hour physician referral service at 1-800-544-2500 or 412-647-7000.
Reference
Ozaki S, Kawase I, Yamashita H, Uchida S, Takatoh M, Kiyohara N. 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. PMID: 29567131.
