TAVR Bests Surgical Redo for Failed Bioprostheses: Early Data

The 30-day valve-in-valve results come with caveats: more information about long-term valve durability is needed.

Lancet COVID-19 Hydroxychloroquine Study Faces ‘Data Integrity’ Questions

Implanting a transcatheter heart valve inside a failed aortic bioprosthesis is associated with better short-term clinical outcomes compared with repeat surgical valve replacement, according to a new analysis of the National Readmissions Database.

In a propensity-matched analysis of US patients treated with surgery or a transcatheter heart valve for a degenerated aortic bioprosthesis, valve-in-valve TAVR was associated with a significantly lower risk of mortality at 30 days (adjusted OR 0.41; 95% CI 0.23-0.74), as well as a lower risk of morbidity (adjusted OR 0.56; 95% CI 0.43-0.72) and major bleeding (adjusted OR 0.66; 95% CI 0.51-0.85), when compared redo surgery.

“Valve-in-valve TAVR patients do extremely well in the short term, and for older patients and very sick patients, I think it’s an excellent strategy,” senior investigator Tsuyoshi Kaneko, MD (Brigham and Women’s Hospital, Boston, MA), told TCTMD. “I believe that for a lot of the younger patients, this will be applicable, but I do think we will need to know a little more about the long-term outcomes and durability to say that this will be the gold standard for all patients.”

For patients with a failed bioprosthetic aortic valve, redo surgery is the current benchmark given its established long-term outcomes, although TAVR use has been increasing since 2015 when the US Food and Drug Administration approved expanded indications for CoreValve (Medtronic) and Sapien XT (Edwards Lifesciences) transcatheter heart valves to include valve-in-valve procedures for patients at high risk for surgery. To TCTMD, Kaneko said surgery has long been performed in an “excellent fashion” for many years, but it is associated with higher operative mortality and higher overall morbidity.

“It’s not a simple, straightforward operation by any means,” he said. “When you think about patients who get a [redo] surgical aortic valve replacement, and you’re looking at 10 or 15 years down the road when they come back with these failed bioprostheses, they are older and frailer when they go into the second procedure. When the FDA approved valve-in-valve TAVR, it has changed the management of these patients in a way. For these older, frail patients, valve-in-valve TAVR is an extremely well tolerated procedure. It’s minimally invasive and they recover [much] faster compared with surgical aortic valve replacement.”

Large Numbers of TAVR and Surgical Patients

In the present study, which was published May 23, 2020, in the European Heart Journal, Kaneko along with investigators led by first author Sameer Hirji, MD (Brigham and Women’s Hospital), performed a head-to-head comparison of redo surgery against valve-in-valve TAVR in US adults with a degenerated bioprosthetic aortic valve. They identified 3,443 patients who underwent the transcatheter valve-in-valve procedure and 3,372 patients who were treated with surgery. Before matching, those referred for valve-in-valve TAVR were nearly 5 years older (mean 75.2 vs 70 years) and were significantly more likely to have chronic kidney disease, congestive heart failure, and to have undergone prior CABG surgery.

I do think we will need to know a little more about the long-term outcomes and durability to say that this will be the gold standard for all patients. Tsuyoshi Kaneko

In the unadjusted analysis, the valve-in-valve TAVR patients had lower rates of 30-day mortality, 30-day morbidity (a broad composite that included pneumonia, pulmonary embolism, renal failure, cerebrovascular accident, myocardial infarction, cardiac arrest, adult respiratory distress syndrome, sepsis, and septic shock), and major bleeding complications compared with the surgical group. For those treated with TAVR, the 30-day mortality rate was 2.8% (versus 5.0% with surgery), which lines up with data from the Society of Thoracic Surgeons/American College of Cardiology TVT Registry. Additionally, hospital length of stay was shorter in the TAVR-treated patients and they were more likely to be discharged home. There were no differences in the rates of postoperative stroke, renal failure, permanent pacemaker implantation, or complete heart block between the TAVR and surgical groups.

In the multivariable-adjusted analysis, valve-in-valve TAVR remained associated with significantly lower risks of 30-day mortality, 30-day morbidity, and major bleeding, as well as a shortened hospital stay and greater likelihood of being discharged home, and these same results were also observed in the propensity-matched analysis of 2,181 patients treated with TAVR and 2,181 treated with surgery.

Adnan Chhatriwalla, MD (Saint Luke’s Mid America Heart Institute, Kansas City, MO), who wasn’t involved in the study, said the excellent short-term results are not particularly surprising, particularly with current-generation TAVR devices. Like Kaneko, he said the biggest unknown is how well the transcatheter heart valves perform over time.

“It’s a good study, but the real concern with valve-in-valve TAVR, and the [researchers] do a great job acknowledging this in their discussion, is durability and what it means to have a constrained TAVR valve, with leaflets that may not be opening or closing the way they were intended to,” Chhatriwalla told TCTMD.

When the surgical ring is fractured during a valve-in-valve procedure, the leaflets of the transcatheter heart valve can open and close without the “scalloped” or “pinwheeling” effect observed when the valve is constrained, he added. In 2017, Chhatriwalla and colleagues published data on a small series of 20 patients and showed that bioprosthetic valve fracture performed before or after valve-in-valve TAVR reduced transvalvular gradients and increased the valve effective orifice area.

More to Learn About Valve-in-Valve TAVR

To TCTMD, Kaneko said while valve-in-valve TAVR is FDA-approved for high-risk patients, there has inevitably been some “risk creep” into lower-risk patients. He stressed their positive short-term results should be interpreted cautiously, noting they were unable to assess long-term clinical outcomes in the National Readmissions Database. “If you’re doing these valve-in-valve TAVR procedures in a younger patient, how [the valves] are going to perform in 5 or 10 years still remains in the dark,” he said. “We just don’t know yet.”

Other issues that need to be addressed with valve-in-valve TAVR include higher residual gradients and patient-prosthesis mismatch, which is likely caused by the underexpansion of the transcatheter heart valve in a failed surgical bioprosthesis, said Kaneko.

To TCTMD, Chhatriwalla pointed to data from the Valve-in-Valve International Data (VIVID) registry published in 2014 that suggested patients with small surgical bioprosthetic aortic valves (label size ≤ 21 mm) tend to fare significantly worse when treated with valve-in-valve TAVR. In that analysis, the overall 1-year survival rate was 83.2% in 459 patients with degenerated bioprosthetic valves undergoing valve-in-valve implantation between 2007 and May 2013 in 55 centers. However, mortality varied significantly by valve size, with 74.8%, 81.8%, and 93.3% of patients with small-, intermediate-, and large-sized valves alive at 1 year, respectively.  

“There’s definitely a difference between valve-in-valve TAVR and native-valve TAVR,” said Chhatriwalla.

Another concern is the risk of coronary obstruction with valve-in-valve procedures, a risk that varies depending on the initial surgical valve. “These nuances with the anatomical features and complications can’t be really teased out from this database,” said Kaneko, noting that the BASILICA procedure, which lacerates the leaflets to prevent coronary obstruction, might be a potential workaround for patients with anatomies at high risk for the complication. However, if valve-in-valve TAVR can only be facilitated with BASILICA in a young patient, that patient might be a better candidate for surgery, said Kaneko.

Michael O’Riordan is the Associate Managing Editor for TCTMD and a Senior Journalist. He completed his undergraduate degrees at Queen’s…

Disclosures
  • Kaneko reports speaker fees from Edwards Lifesciences, Medtronic, Abbott, and Baylis Medical, and consulting for 4C Medical.

Comments