The “Ross procedure” could mean better long-term survival and fewer complications than prosthetic valves for young adults undergoing aortic valve surgery, according to new 17-year data analyses. Unlike standard open-heart procedures for repair with mechanical or biological aortic valve replacement (AVR) from a human or animal donor, the Ross procedure uses the patient’s own living pulmonary valve, and replaces the pulmonary valve with an allograft. The current study – published online Monday ahead of the March 1 issue of the Journal of the American College of Cardiology – is the first to compare the Ross procedure to its prosthetic alternatives. “To this day, this is the only operation that has ever been shown to restore survival after aortic valve replacement in young adults,” lead author Ismail El-Hamamsy, MD, PhD, of Icahn School of Medicine at Mount Sinai, New York, said in an accompanying press statement. The study was carried out in response to issues with standard valve replacement procedures in younger adults (i.e., those aged 18 to 50 years). Although bioprostheses are the “favored option” for older patients, their use in younger people is associated with higher rates of structural valve regeneration and reoperation, the researchers noted. Mechanical valves do represent a more durable option but require lifelong anticoagulation and, often, lifestyle modifications such as avoiding contact sports, which could lead to falls and bruising. The Ross procedure has emerged with data signaling restored long-term survival compared to the general population, the researchers noted, but lamented that most associated studies have been single-center (and often single-surgeon) and do not compare with standard procedures. The researchers, therefore, set out to study long-term survival, reoperation, stroke, major bleeding and endocarditis in 1,302 propensity-matched young (<50 years) adults undergoing mechanical AVR, biological AVR or a Ross procedure in California and New York state between Jan. 1, 1997, and Dec. 31, 2014 (434 patients per group). The patients were around the same age (a median of 35.9 years in the Ross procedure group, 36.2 for bioprosthetic AVR and 36.7 in mechanical AVR) and sex, were majority white (74%, 71% and 71% respectively), and had similar rates of conditions including hypertension, atrial fibrillation and congestive heart failure. Those with concomitant mitral and/or tricuspid valve surgery or coronary artery bypass grafting, end-stage renal disease, intravenous drug use, acute aortic dissection, infective endocarditis, any history of carcinoid disease, or Marfan syndrome were excluded because of the potential impact on long-term outcomes. At 15 years post-procedure, all-cause mortality was significantly lower after the Ross procedure compared with biological AVR (hazard ratio [HR]: 0.42; 95% confidence interval [CI]: 0.23-0.075; P = 0.003) and mechanical AVR (HR: 0.45; 95% CI: 0.26-0.79; P = 0.006) Further, Ross procedure actuarial survival was similar to that of the age, sex, and race-matched general U.S. population, at 93.1% (95% CI: 89.1% - 95.7%). “Not only was survival better than after biological or mechanical aortic valve replacement, it was also identical to the matched U.S. general population,” El-Hamamsy stressed. “This is a huge deal because it demonstrates the impact of valve choice in the long term.” The Ross procedure was also associated with lower cumulative risk of reintervention (P = 0.008) and endocarditis (P = 0.001) than biological AVR. Compared to mechanical AVR, stroke risk was lower for the Ross procedure (P = 0.03), as was major bleeding risk (P = 0.016); however, there was a higher cumulative incidence of reoperation (P > 0.001). Yet, “although mechanical prostheses provide excellent durability, this approach is associated with a constant risk of major bleeding or stroke,” the researchers stressed. The researchers also assessed 30-day mortality after the occurrence of any valve-related complication and found the lowest mortality rate was associated with reoperation (1%). Stroke was associated with 5.6% mortality and endocarditis with 13.5%. “Importantly, early mortality associated with different valve-related complications varies widely and is lowest if reintervention is needed,” the researchers said. The study confirms the notion that a living valve substitute in the aortic position improves clinically relevant outcomes in young adults, the authors concluded. Although the Ross procedure is associated with a “definite risk of reoperation,” that risk is low and should be seen as a “bump on the road, rather than the end of the road,” said El-Hamamsy. “In contrast, if patients suffer a stroke, hemorrhage, or infection, the consequences are much more dire […] Patients should be given all this data so they can make truly informed decisions about these major life events.” In any case, “the Ross procedure should be considered the option of choice for young adults requiring isolated replacement of the aortic valve,” the authors said. Yet they stipulated an important caveat: “the Ross procedure is a more complex operation and should only be performed in Ross centers of excellence,” said El-Hamamsy in the press release. “When done in that setting, this represents a major breakthrough for young patients with aortic valve disease, including young women contemplating pregnancy.” El-Hamamsy’s team – which has the largest experience worldwide for Ross procedures – aired hopes that the findings will further encourage the development of regional Ross centers of excellence to improve patient access and safety. In an accompanying editorial, Magdi H. Yacoub, Imperial College, London, pointed out one potential “confounding factor in the Ross series studies” – namely whether the pulmonary autograft was inserted in the subcoronary position or as a free-standing root, which could influence the outcome. Nevertheless, Yacoub stressed that the data are compelling and “should help to influence practice, and propel the Ross operation along the long road to the clinic.” Sources: El-Hamamsy I, Toyoda N, Itagaki S, et al. Propensity-Matched Comparison of the Ross Procedure and Prosthetic Aortic Valve Replacement in Adults. J Am Coll Cardiol 2022;79:805-815. Yacoub MH. The Ross Operation and the Long Windy Road to the Clinic. J Am Coll Cardiol 2022;79:816-818. Image Credit: Vital – stock.adobe.com