Better 15-Year Survival With Ross Procedure Than Bioprosthetic AVR

Patients whose aortic valve disease is treated with the Ross procedure are more likely to be alive 15 years later than those who undergo aortic valve replacement (AVR), whether that’s with bioprosthetic or mechanical valves, researchers say.

The findings, from a retrospective analysis of cases done in California and New York over an 18-year time span, were published online yesterday in the Journal of the American College of Cardiology.

Ismail El-Hamamsy, MD, PhD (Mount Sinai Hospital, New York, NY), pointed out to TCTMD that their results are unique by virtue of coming from statewide databases, rather than from a single surgeon or center. The study also provides a rare comparison between Ross and biological AVR, which “now has become the favored option for young adults, because of the potential for valve-in-valve therapies in the future,” he noted.

The long-term advantage for Ross over mechanical AVR has largely been attributed to the need for anticoagulation with the latter, said El-Hamamsy. “Perhaps if you don’t need anticoagulation”—as with biological AVR—“then you may not incur such a survival penalty, but it turns out that that is not the case. In fact, if you look at the analysis, survival of patients after a tissue or mechanical AVR was exactly identical in this series.”

What that means, he continued, is that the more-important ingredient to survival is having a “living valve” implanted in the aortic position, as is done with Ross. In the Ross procedure, the patient’s aortic valve is removed and then replaced with their own pulmonary valve. “It remains alive over time,” El-Hamamsy said, “so it can perform many of the functions that the native aortic valve does in terms of ensuring a perfect blood flow and good coronary flow reserve, and reducing the ventricular work load, et cetera.”

Uptake of the Ross procedure has been limited over the decades by misconceptions, he said. Among them are the idea that the initial Ross procedure is associated with a “much higher operative mortality” than conventional AVR and that all Ross patients will need to undergo a repeat procedure within 10 to 15 years. But a growing evidence base shows that in experienced hands Ross operations are safe and effective.

California and New York Patients

The researchers searched California and New York databases for adults aged 18-50 who’d undergone the Ross procedure, bioprosthetic AVR, and mechanical AVR between 1997 and 2014. After excluding patients who had concomitant procedures or reoperations, had infective endocarditis, used IV drugs, were receiving hemodialysis, and lived out-of-state, they arrived upon 434 propensity-matched patients in each of the treatment groups. Median follow-up duration was 12.5 years.

At 15 years, the Ross-treated patients’ actuarial survival, 93.1%, matched that of the US general population when accounting for age, sex, and race (HR 0.97; 95% CI 0.94-1.01). All-cause mortality, the primary endpoint, after the Ross procedure was significantly lower compared with both biological AVR (HR 0.42; 95% CI 0.23-0.75) and mechanical AVR (HR 0.45; 95% CI 0.26-0.79).

The 15-year risk of stroke with the Ross procedure (2.1%) was similar to that seen with biological AVR (3.3%) but lower than it was with mechanical AVR (4.8%). Major bleeding followed similar patterns among the three groups (1.9%, 3.3%, and 5.2%, respectively). For endocarditis, rates were similar between the Ross procedure and mechanical AVR (2.3% vs 3.7%) and highest after biological AVR (8.5%).

By 15 years, patients who first underwent bioprosthetic AVR had the highest incidence of aortic and/or pulmonary valve reintervention (29.8%). Repeat procedures were less common after Ross (17.2%), and least frequent with mechanical AVR (7.4%).

El-Hamamsy stressed that these complications aren’t all created equal when it comes to clinical consequences. All-cause mortality at 30 days was 1.1% after reoperation, 2.6% after major bleeding, 5.6% after stroke, and 13.5% after endocarditis.

“I always tell patients that there’s no perfect solution, and the Ross isn’t a perfect solution either,” he acknowledged. “Every choice that you make comes with its own set of valve-related complications. . . . As clinicians and surgeons and even patients, we tend to see reoperation as the worst thing that can happen to someone, [but] what this data shows is that a reoperation is really just a bump in the road, rather than the end of the road.” And when “you have to pick your poison,” knowing that the mortality risk is lower with reoperation than it is after other complications makes the argument for Ross, he added.

The Quest for Better Durability

Surgical techniques for Ross have evolved in recent years, making it now “much more durable,” said El-Hamamsy. What “you’re seeing in this study are data from patients still operated on before many of these technical modifications were introduced and became the standard.” If measured today, the need for reoperation would be lower, he predicted, though that’s impossible to know just yet due to short follow-up duration.

Beyond technique, there are other improvements likely to improve Ross’ durability, he said, such as use of pulmonary homografts that have been decellularized, rather than just treated with antibiotics. Biodegradable jackets placed around the pulmonary valve at the time of implantation into the aortic position are being tested as a means to support the homograft as it heals and adjusts. Especially key, he stressed, is the use of remote BP-monitoring, which can provide early feedback on high systolic pressures that, if left uncontrolled, might lead to dilatation then reoperation.

“I think right now we’re at a stage where the Ross is at a very mature phase in terms of execution,” El-Hamamsy said. Next steps are “teaching more surgeons to do it safely and effectively and also educating cardiologists about it’s real role, because there are still a lot of misconceptions and ‘old thinking’ in the community about the role of the Ross in adults.”

He hopes their study and other accumulating data add to the argument for reconsidering the role of Ross in guidelines. US recommendations set it as class IIb, and the European guidelines fail to mention it at all. “The one caveat [in these discussions] is that this should only be performed in Ross centers of excellence, just like we do for mitral valve repair,” said El-Hamamsy.

This doesn’t mean everyone is a candidate, however. El-Hamamsy said exceptions include patients whose aortic regurgitation can be treated by aortic valve repair, those with connective tissue disorders, and those whose expected life span is too short to reap Ross’ benefits.

Magdi H. Yacoub, MBChB (Aswan Heart Centre, Egypt, and Harefield Hospital, England), in an editorial accompanying the JACC paper, describes the procedure’s “long windy road to the clinic.” This latest study is “compelling” and “strengthens the notion that a ‘living’ valve substitute can prolong life,” he notes.