ViV TAVR: New Durability and BASILICA Data Stress Need to Plan Ahead

Two new studies examining the long-term durability and outcomes associated with valve-in-valve TAVR, as well as a new approach to improving outcomes in patients who need coronary protection, are shedding light on the techniques.

Key takeaways, said Danny Dvir, MD (University of Washington, Seattle), who presented both studies last week at the PCR e-Course 2020, are the importance of implanting larger valves during the index procedure, and that valve-in-valve reintervention rates appear to be higher with balloon-expandable transcatheter devices.

“We know that there are more patients implanted with bioprosthetic valves, bioprosthetic valves are prone to structural valve degeneration—they have limited durability—and there are more aortic valve-in-valve procedures,” Dvir told TCTMD. “One of the issues with TAVR valve-in-valve is that we finish with residual gradient. . . . So we are very much concerned about the durability of these procedures. We are also concerned about the need for reintervention in these cases because of the suboptimal hemodynamics that we get.”

Commenting on the studies for TCTMD, Philippe Généreux, MD (Morristown Medical Center, NJ), said the primary take-home message from Dvir’s presentations is that it is “crucial” to plan the first valve procedure appropriately so as to anticipate future reinterventions. “If you have a large anatomy, you're probably going to be fine independently of the valve replacement strategy,” Généreux said. “But when you have a small anatomy, this is where it's very important to use cautiously the best technique to ensure a good long-term outcome and maybe use surgical root enlargement using a TAVR that will allow you safely to do a valve-in-valve in the future.”

Valve-in-Valve TAVR in the Long-Term

For the first study, simultaneously published in the European Heart Journal, Dvir along with Sabine Bleiziffer, MD, PhD (Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen, Germany), and colleagues analyzed 1,006 aortic valve-in-valve procedures from the VIVID registry performed before December 2014. Mean patient age was 77.7 years and median STS-PROM score was 7.3%. About half (52.0%) of patients received self-expanding valves (CoreValve/Evolut; Medtronic), while 43.2% received balloon-expandable devices (Sapien/Sapien XT/S3; Edwards Lifesciences).

We are very much concerned about the durability of these procedures. Danny Dvir

Survival at 8 years was 38% overall and generally lower for patients with small (internal diameter ≤ 20 mm) compared with large failed devices (33.2% vs 40.5%; P = 0.01). There was no difference in survival according to valve type when looking only at small devices (P = 0.10).

Small failed bioprostheses, older age, lower baseline LVEF, chronic kidney disease, diabetes and nontransfemoral access all were independent predictors of mortality. Independent predictors of reintervention were pre-existing severe patient prosthesis mismatch, device malposition, balloon-expandable valve use, and older age.

“We can do several things in the cath lab that can really change clinical outcomes,” Dvir said. “The type of device that we implant originally before the valve-in-valve is really important. Also, small bioprosthetic valves are associated with worse outcomes. We need to implant larger valves. The second thing, the type of the TAVR device can also affect clinical outcomes. Balloon-expandable devices were associated with higher reintervention rates.”

While valve-in-valve practice has changed somewhat since 2014, including increased anticoagulation use as well as bioprosthetic ring fracture, Dvir said the data represent “a good slice of all valve-in-valves from the early days. . . . It did confirm the risk associated with implanting a small surgical valve or by having severe prosthetic patient mismatch on patient clinical outcomes. Originally there was some doubt as to whether these were important.”

Généreux said if this analysis were based on today’s valve-in-valve procedures, it would include a greater proportion of larger prostheses as well as more use of dedicated surgical valves that can be expanded better. “And we are using other techniques to optimize the valve-in-valve resolving, so fracturing the surgical valve and BASILICA,” he added. “We are optimizing everything including the initial surgical implant and valve-in-valve procedure.”

New BASILICA Data

For the second study, Dvir presented the latest multicenter registry data on BASILICA, a technique of lacerating the preexisting aortic leaflet (native or failed prosthetic) with radiofrequency immediately before TAVR in patients at high risk for coronary obstruction.

As previously reported by TCTMD, the BASILICA IDE trial showed success among a cohort of 30 patients with investigators reporting no cases of coronary obstruction at 30 days. However, one patient died and three had a stroke.

In the new analysis, Dvir and colleagues included 129 successful BASILICA procedures, including 22 cases of double BASILICA, wherein both the left- and right-sided leaflets are lacerated. Compared with controls, 30-day mortality was lower with single BASILICA but higher with double BASILICA. The procedure was also associated with higher stroke risk but less coronary obstruction or the combination of death, stroke, and coronary obstruction over 30 days with single BASILICA.

30-day Outcomes

 

“Basically, the most important message is that double BASILICA is big trouble,” Dvir stressed. “Double BASILICA has poor clinical outcomes similar to controls, while single BASILICA had great clinical outcomes. . . . When you have two leaflets at risk for coronary obstruction, left and right, we cannot support doing that with BASILICA. We may need to consider alternative strategies.”

One of these strategies might be watchful waiting, while another might be sending the patient for redo surgery, he suggested. Valve-in-valve TAVR could also be an option for some with chimney or snorkel stenting to protect the coronaries.

“BASILICA is a technique that has had a lot of press lately, but not a lot of operators are using it, for two reasons,” Généreux said. “First, it's pretty rare that we are encountering a procedure [where] we'll need this technique. And second, there's a learning curve on this technique that is not trivial.”

I wish I could be able to do it, but it's too dangerous for me to try that. Philippe Généreux

Also, he acknowledged, the procedure is not without risk, specifically in terms of stroke. “It's not hard to understand when you look at all the procedures—it's time consuming, there's a lot of manipulation involved in the surgical valve, and there's other thrombotic material there with a risk of embolization—so, it's not a walk in the park,” Généreux explained, adding that very few operators are competent in BASILICA worldwide.

Also, he continued, it’s not clear which patients will respond well to BASILICA in the long-term, especially as coronary access might be needed down the line. “It's not only about keeping the coronary open, but it's also about how you will access the coronary in the future, and when you have a big prosthesis in front of that, it might be difficult.”

More research and experience will be needed with BASILICA before it can “go mainstream, according to Généreux. “BASILICA is like CTO was 10 years ago. It's a new technique, looks crazy, I wish I could be able to do it, but it's too dangerous for me to try that,” he said. “It's still in development, it still needs to be optimized, and we need better tools and to better understand the benefit of it.”

Photo Credit: Danny Dvir