Patients who underwent aortic valve replacement with a pulmonary autograft — an approach called the Ross procedure — had a survival rate comparable to that of the healthy general population after 12 years of follow-up, according to a recent study.

The Ross procedure was also associated with significant valve durability and low rates of reintervention. These findings, coupled with the survival data, appear to confirm “the fundamental advantage” of restoring “a living valve to the aortic position,” principal investigator Ismail El-Hamamsy, MD, PhD, said in a news release.

El-Hamamsy, who is a professor of cardiovascular surgery at the Icahn School of Medicine at Mount Sinai in New York City, also noted the results single out the Ross procedure as “the only aortic valve replacement operation that has consistently been shown to restore life expectancy to that of the general population.”

A Treatment for Aortic Regurgitation, Stenosis

In the study, published online on June 23 in the Journal of the American College of Cardiology, El-Hamamsy and colleagues tracked outcomes in 455 consecutive patients who underwent aortic valve replacement with the Ross procedure between 2011 and 2019 at a single, high-volume Ross reference center. Relative to outcomes reported for other types of aortic valve replacement, including surgical and transcatheter aortic valve replacement (TAVR), the 9-year data have established the Ross procedure as a “new benchmark,” El-Hamamsy said in an interview.

Of the patients in the study, 285 (63%) had aortic stenosis, 11% had pure aortic regurgitation, and the remainder had mixed aortic disease.

At 12 years, the cumulative incidence of aortic reintervention was 1.1%, with no meaningful difference for those treated for aortic stenosis or regurgitation, and the cumulative incidence of cardiac reintervention for any reason was 3.5%. There was no prosthesis mismatch in any patient, and the placement of a pacemaker was performed in just three patients (0.8%).

The benefits of the Ross procedure were about the same for patients older than 50 years as for younger patients. This finding is notable, according to El-Hamamsy, because the Ross procedure, first described in 1967, has been largely evaluated in younger patients.

Employed for some time following its initial description, the Ross procedure fell into disfavor in the early 2000s when prosthetics became more attractive, according to a recent review article in the Journal of the American Heart Association. However, it has been resurrected at least in part due to better surgical techniques in the contemporary era.

The Ross procedure, performed with the assistance of a heart-lung bypass machine, involves excising the diseased aortic valve and replacing it with the patient’s native pulmonary valve sewn into aortic position. An allograft replaces the pulmonary valve.

Importantly, many experts, including El-Hamamsy and Jordan P. Bloom, MD, MPH, author of the JAHA review, emphasized the role of skill and experience.

“The Ross procedure is a technically demanding operation that requires careful patient selection, meticulous surgical technique, and dedicated longitudinal follow-up,” said Bloom, who is surgical director of adult congenital heart disease at Massachusetts General Hospital, Boston. Yet based on several recent studies, not just the latest series, he agreed that it could be a new standard “in experienced hands.”

The advantage of a living valve is that “it preserves both the native effective orifice area and the dynamic function of the aortic root,” Bloom said. “This allows patients to achieve high cardiac outputs during exercise without the hemodynamic limitations often associated with prosthetic valves.”

Importance of Experience

Yet these advantages depend on experience, said El-Hamamsy. This point was echoed in an editorial accompanying the JACC study by Maral Ouzounian, MD, PhD, chief of cardiovascular surgery at the Peter Munk Cardiac Center of the University of Toronto in Toronto, Ontario, Canada and colleagues.

In the editorial, Ouzounian highlighted many impressive results in this new series, such as a mean aortic valve gradient of only 4 mm Hg at 12 years — a sign of “superior hemodynamic performance relative to any prosthetic valve or TAVR.”

She also agreed with El-Hamamsy that the Ross procedure is already a benchmark even if the ultimate durability will not be known into the second and third decades of follow-up. However, citing a recent study that associated procedures performed at low-volume centers with a “concerning increase in mortality,” Ouzounian called for quality metrics to establish expertise in performing this procedure.

The favorable outcomes in this study are not isolated among recent reports. A study of 477 patients, published in January, which drew data from the four participating centers of the North American Ross Consortium, compared outcomes between patients aged older and younger than 50 years.

Despite more comorbidities, such as preoperative hypertension, perioperative outcomes, including in-hospital mortality, were comparable between the two age groups. Freedom from valve reintervention at 10 years was also similar — 84% for the entire cohort. The overall survival rate of 96% at 60 months was excellent in both groups even though it was significantly higher in younger patients (97% vs 94%; P < .001).

Lead author of the study, Scott DeRoo, MD, is enthusiastic about the Ross procedure but cautioned that it is still a class IIB recommendation in the 2020 American College of Cardiology/American Heart Association Guideline for the management of patients with valvular hear disease. He expects this to change.

Ross Called a Gold Standard for Valve Repair

“There are now several large, longitudinal studies that demonstrate excellent long-term outcomes in patients undergoing the Ross procedure. When performed at experienced centers in appropriately selected patients, the Ross procedure is proving to be the new gold standard of care at least for young patients with aortic valve disease,” said DeRoo, chief of thoracic surgery at the Seattle VA Medical Center and an assistant professor at the University of Washington, Seattle.

DeRoo championed organizations such as the North American Ross Consortium for collecting data across centers to strengthen an understanding of risks and benefits of this operation outside of a clinical trial. Like others, he echoed the need for expertise.

Much as the results with the Ross procedure have been remarkable, El-Hamamsy also cited worse outcomes at low-volume centers to emphasize that results appear dependent on both volume and expertise.

However, the fact that “life expectancy, quality of life, and exercise capacity are normal” after a Ross replacement when compared to age-matched populations shows that in the right hands at the right institution, the procedure could be standard.

When expertise is available, “the Ross procedure should therefore be considered in all patients with aortic valve disease and have an anticipated life expectancy of 15-20 years,” he said.

El-Hamamsy, Bloom, Ouzounian, and DeRoo reported having no relevant financial disclosures. Bloom reported having a financial relationship with Sanofi.