Valve-in-Valve TAVR Success May Depend on Original Surgical Decisions

Shelley Wood

July 08, 2014

CHICAGO, IL — The largest-ever review of transcatheter aortic-valve replacement (TAVR) procedures for failed bioprosthetic valves suggests that TAVR could play a key role in solving a problem that will only grow in the coming years[1].

So-called "valve-in-valve" procedures are off-label in many countries, including the US, although both the CoreValve (Medtronic, Minneapolis, MN) and Sapien (Edwards Lifesciences, Irvine, CA) devices have CE Mark for valve-in-valve usage in Europe. But as the lead author on a new paper told heartwire , there are burgeoning numbers of patients who received bioprosthetic valves within the past two decades who are now faced with degenerating devices. In many of these patients, now older with more comorbidities, open surgical replacement—the standard of care—is no longer an option.

"Currently bioprostheses are the most common devices implanted during cardiac surgery," Dr Danny Divr (St Paul's Hospital, Vancouver, BC) told heartwire . "They fail within 10 to 20 years, their durability is limited, and we can expect that in a couple of years there will be many more bioprosthetics that will fail." Repeat cardiac surgery "is very high risk" in many of these patients, he continued, "so valve-in-valve is very appealing, and we expect that practice to grow."

TAVR for failed bioprosthetic valve (Courtesy of the VIVID Registry)


Writing in the July 9, 2014 issue of the Journal of the American Medical Association, Divr and colleagues report one-month and one-year outcomes following valve-in-valve procedures among a total of 459 patients from 55 centers in Europe, North and South America, Australia, New Zealand, and the Middle East participating in the Valve-in-Valve International Data (VIVID) Registry. All TAVR valve-in-valve procedures in the registry were performed between 2007 and 2013. Modes of failure for the original bioprosthesis were stenosis (40%), regurgitation (30%), or both.

Both one-month and one-year survival following TAVR were high, at over 90% and over 80%, respectively.

"One-year survival overall is 83%, and we see that the stroke rate is very low [1.7% for major stroke at one month], and the functional class of patients who survive is excellent [NYHA class 1/2]," Dvir said. "We are very happy, in general, with valve-in-valve outcomes."

What's clear, however, is that valve-in-valve is "probably a family of procedures, not a single procedure," Dvir stressed. Importantly, it is features of the original surgical-valve procedure, and less so features of the second TAVR procedure, that appear to drive success. For example, a difference was seen depending on the original mode of bioprosthetic valve failure, with lower survival seen among those requiring reintervention for surgical-valve stenosis than among those requiring a new valve for regurgitation (76.6% vs 91.2%). One-year survival among patients with both problems was roughly halfway between the two, at 83.9%.

Similarly, a smaller surgical valve size was associated with significantly worse survival than in bioprosthetic valves that were larger than 21 mm. Higher STS score, as expected, was also associated with worse survival. "So all of these have a lot of implications not only for interventional cardiologists, but also for the surgeons who implant the original devices," Divr said.

No "robust clinical outcome differences" were seen between the CoreValve and the Sapien (used in 46.4% and 53.6%, respectively, of valve-in-valve cases), Dvir said, although the balloon-expandable Sapien tended to be used more commonly in the setting of stenosis, whereas the CoreValve was used more commonly in the setting of bioprosthetic valve regurgitation.

"We did see previously and also in the current analysis that there are different hemodynamics after the procedure that were in favor of the CoreValve, but these did not translate into significant differences in one-year survival or functional class of the patient," he said.

Not unexpectedly, patients treated via a transfemoral valve-in-valve procedure had better outcomes than patients treated via a transapical route, but the latter were also more likely to have more comorbidities, including peripheral vascular disease.

Dvir and his coinvestigators believe their results support TAVR as a key solution for bioprosthetic valves that require reintervention but hope their study will also have an impact on the surgical community implanting these valves in the first place. "Surgeons should be aware that their technique is crucial to allow for the possibility of successful valve-in-valve implantation when bioprosthesis failure occurs years later," they write. "According to the VIVID Registry analysis, valve-in-valve outcomes are worse in patients with small surgical valves (label size =21 mm) and those with stenosis as the mechanism of failure."

As such, they continue, "an attempt to address these limitations may possibly be made during the index procedure by providing the largest effective orifice area achievable."

Dvir had no conflicts of interest. Disclosures for the coauthors are listed in the paper.


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