CryoLife (Kennesaw, Georgia) hosted a two-day Ross Summit late last week during which cardiovascular surgeons from around the world discussed their experiences with the Ross procedure, a type of specialized aortic valve surgery in which the patient's diseased aortic valve is replaced with his or her own pulmonary valve. The pulmonary valve can then be replaced with a cryopreserved human pulmonary valve.
The Ross Summit began Friday and ran through Saturday.
On Friday a question was raised about the appropriateness of performing the heart valve procedure in very young children. This question was asked after Michael Huebler, MD, presented his experience with the pediatric Ross procedure at the Berlin Heart Center (Germany). Huebler noted that Hans Sievers, MD, of Luebeck, Germany, who also presented during the summit, trained him on the Ross procedure in 2000.
Since 2000, Huebler said about 24 Ross procedures are performed at the Berlin Heart Center a year and that the number of pediatric Ross procedures is increasing. About 50% of the Ross procedures performed at the center are in the pediatric age group now, he noted. "Our indications for the pediatric Ross procedure is a growing child with an aortic valve disease," Huebler said.
He presented Ross procedure data on a total of 58 pediatric patients under age 16, with a mean age of 9.2 years and the youngest patient being just 12 days old. He concluded that the Ross procedure in children has low mortality and morbidity rates, but that "proper training is mandatory."
Following Huebler's presentation an audience member asked him if it is really necessary to use the Ross operation in neonates. "Is there a need to be super aggressive in the very young age?" the audience member asked, suggesting that a more conservative surgery could be done first and then the Ross procedure performed once the child is a little older.
Huebler admitted that, "it is an aggressive approach, but I think you can avoid further procedures if you choose it for the right patient."
The question seemed to influence the results of an audience poll posed at the end of that session in which the majority responded that the Ross procedure is OK for children, but that for very young children it might be best to hold off until they are a little older.
During the Ross Summit, a faculty of more than 30 cardiovascular surgeons and cardiologists presented clinical data on heart reconstruction surgery at their respective clinics. The summit included two sessions of hands-on instruction in the various techniques of cardiac reconstruction. Sir Magdi Yacoub, of Imperial College's Heart Science Center (London) led the summit in tandem with William Northrup III, MD, VP of physician relations and education at CryoLife.
According to CryoLife, nine peer-reviewed articles regarding the Ross procedure representing individual series from eight different countries, comprising a total of 2,234 patients have appeared in major medical journals over the past four years and report that: the procedure is associated with "excellent" long-term survival; late survival with the Ross procedure is comparable to that of the age-matched general population; and there is an "excellent" propensity-adjusted survival with the Ross procedure in a pediatric patient population study compared to the excess mortality demonstrated with using a mechanical valve (as reported by one of the nine reports).
CryoLife noted that a decellularized human pulmonary heart valve, CryoValve SG, processed using the company's SynerGraft technology, was cleared by the FDA in February 2008 for use in cardiac reconstruction procedures, which includes the Ross procedure (Medical Device Daily, Feb. 11, 2008).
According to CryoLife, the Ross procedure is performed on up to 1,500 individuals globally each year – a number that is expected to increase as survival data become more widely known.
"In children, young adults and in active older adults, the Ross procedure offers several advantages over other traditional aortic valve replacement options," Northrup said. "The most important advantage is growing evidence of improved long-term survival over other valve replacement options. The procedure is also attractive because patients do not have to take long-term, blood-thinning medications after surgery as they would with mechanical valves. This is particularly appealing to women of child-bearing age, athletes and active adults."
These advantages along with the growing catalog of survivability data spotlighted at the summit are bringing new attention to the procedure from surgeons and potential patients, the company said.
"The Ross procedure requires very specific surgical expertise to achieve predictable, long-lasting results, and the Ross Summit was created to foster data exchange to provide a well-rounded point of view in addition to offering critical procedural training," noted Steven G. Anderson, chairman, president and CEO of CryoLife.
CryoLife processes and distributes implantable living human tissues for use in cardiac and vascular surgeries throughout the U.S. and Canada. Its CryoValve SG pulmonary human heart valve, processed using the company's SynerGraft technology, has FDA 510(k) clearance for the replacement of diseased, damaged, malformed or malfunctioning native or prosthetic pulmonary valves. The company's BioGlue surgical adhesive is FDA approved as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels. BioGlue is also CE marked and approved in Canada and Australia for use in soft tissue repair. n
Amanda Pedersen, 229-471-4212;