Ross Procedure Safe, Effective For Adults Undergoing Aortic Valve Surgery

An analysis comparing 15-year outcomes following Ross procedure and biological or mechanical aortic valve replacement provides insight into the risk of mortality and other adverse outcomes associated with each procedure.

Data from a recent analysis by investigators in the Mount Sinai Health System demonstrates the Ross procedure was associated with more favorable outcomes than mechanical or biological replacements among patients requiring aortic valve replacement.

An analysis of data from more than 1300 patients who underwent aortic valve replacement surgery in California and New York from 1997-2014, results of the study demonstrate the Ross procedure, which is a procedure using the patient’s pulmonic valve as an autograft to replace the aortic valve and a pulmonary homograft to reconstruct the right ventricular outflow tract and pulmonary artery, was associated with a significantly greater rate of survival 15 years post-procedure compared to those who underwent biological or mechanical aortic valve replacement.

“To this day, this is the only operation that has ever been shown to restore survival after aortic valve replacement in young adults,” said lead investigator Ismail El-Hamamsy, MD, PhD, professor of cardiovascular surgery at the Icahn School of Medicine at Mount Sinai and director of aortic surgery for the Mount Sinai Health System, in a statement. “This is a huge deal because it demonstrates the impact of valve choice in the long term. However, there is an important word of caution: the Ross procedure is a more complex operation and should only be performed in Ross centers of excellence. When done in that setting, this represents a major breakthrough for young patients with aortic valve disease, including young women contemplating pregnancy.”

As the research base and popularity of TAVR has grown, so has interest in the Ross procedure. With interest in comparing the outcomes of patients who undergo Ross procedure versus biological and mechanical aortic valve replacement in adult patients requiring primary aortic valve replacement. To do so, investigators designed their study as a propensity-matched analysis of data from the Office of Statewide Health Planning Development database in California and the Statewide Planning and Research Cooperative System in New York from 1997-2014.

From the database, investigators identified a cohort of 16,402 patients aged 18-50 years who underwent primary aortic valve replacement during the study period. After application of exclusion criteria, 8813 patients remained. This cohort included 446 patients who underwent a Ross Procedure, 2795 who underwent a biological aortic valve replacement, and 5582 who underwent mechanical aortic valve replacement. After 3-way 1:1:1 propensity score matching, investigators were left with 3 cohorts containing 434 patients each with a median follow-up time of 12.5 (IQR, 9.3-15.7) years.

Prior to propensity matching, patients who underwent the Ross Procedure were younger and had fewer comorbidities than their counterparts who underwent biological or mechanical aortic valve replacement. After propensity matching, there were no significant difference in demographic characteristics or comorbidities. Investigators pointed out exclusion criteria for the study included requiring 1 or concomitant procedures, reoperations, infective endocarditis, intravenous drug use, hemodialysis, and out-of-state residency.

The primary endpoint of interest for the analyses was all-cause mortality. Secondary outcomes of interest included stroke, major bleeding, reoperation, and endocarditis.

Upon analysis, results indicated the 30-day mortality rate after the Ross procedure, biological, and mechanical aortic valve replacement was 0.23%, 0.69%, and 0.69%, respectively (P=.71). At 15 years, the actuarial survival for these groups was 93.2% (95% CI, 89.0-95.9), 87.9% (95% CI, 83.2-90.6), and 88.4% (95% CI, 84.4-91.5) (log-rank test, P=.005).

For stroke, there was no difference in long-term risk of stroke after a Ross procedure compared to biological aortic valve replacement (HR, 0.61 [95% CI, 0.24-1.57]; P=.30), but risk after a Ross Procedure was significantly lower than after a mechanical aortic valve replacement (HR, 0.37 [95% CI, 0.16-0.89]; P=.03). For major bleeding, there was no significant difference in risk after a Ross procedure compared with biological aortic valve replacement (HR, 0.50 [95% CI, 0.19-1.32]; P=.16), but it was significantly lower after the Ross procedure compared with mechanical aortic valve replacement (HR, 0.32 [95% CI, 0.13-0.81]; P=.016).

Further analysis suggested the Ross procedure was associated with a lower cumulative risk of reintervention (HR, 0.63 [95% CI, 0.45-0.88]; P=.008) and endocarditis (HR, 0.37 [95% CI, 0.17-0.80]; P=.01) compared with biological aortic valve replacement, but a higher cumulative incidence of reoperation than mechanical aortic valve replacement (HR, 2.4 [95% CI, 1.5-3.8]; P=.0002).

“This study demonstrates that while there is a definite risk of reoperation after the Ross procedure, the associated risk is low. In other words, this should be seen as a bump on the road, rather than the end of the road. In contrast, if patients suffer a stroke, hemorrhage, or infection, the consequences are much more dire,” El-Hamamsy added. “Patients should be given all this data so they can make truly informed decisions about these major life events.”

This study, “Propensity-Matched Comparison of the Ross Procedure and Prosthetic Aortic Valve Replacement in Adults,” was published in the Journal of the American College of Cardiology.