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News from EURO PCR 2016: 50% TAVI degenerating after eight years

With the tissue heart valve market at risk due to the expansion of TAVI Into lower risk patients, a presentation at the most recent Euro PCR comes to caution expanding the indication of TAVI  to younger patients.  
 
During the late-breaking clinical trial session Dr Dvir, from St. Paul’s Hospital in Vancouver, British Columbia, took the stage and in a seven-minute presentation punctured the balloon of TAVR enthusiasm with his report titled, “A First Look at Long-Term Durability of Transcatheter Heart Valves (THV): Assessment of function up to 10 years after implantation.”
 
Study Design and major findings:
 
-          704 patients received a TAVR from 2002-2011
  • Edwards SAPIEN XT (36%)
  • Edwards SAPIEN (50%)
  • Cribier-EdwardsTM valves (14%)
-          2 pioneering centers: St. Paul’s Vancouver and University Hospital of Rouen, France
 
-          Final study cohort was 378 patients due to death, insufficient follow-up data points and other exclusion criteria
 
-          Kaplan-Meier Freedom from Valve Degeneration
  • 94% at 4 years
  • 82% at 6 years
  • 50% at 8 years
 
 
Citations:
 
Dr Dvir, St. Paul’s Hospital, Vancouver, Canada:
 
  • “The clinical implications from this signal is that everyone should know there is a phenomenon of THV degeneration so that when we target younger patients, lower risk patients who may survive longer, their valve may fail.”  
  • “The median time to degeneration was five years,” he reported, showing that what is seen over time are leaks, or calcified bulky leaflets where mobility is severely reduced, or an asymmetric degeneration where one of the leaflets breaks down in performance faster than the others.  
  • "Physicians performing TAVI in younger patients and in those expected to survive long after the procedure should be aware that the long-term rate of TAVI degeneration is not negligible, at least for first-generation TAVI devices" 
  • "Physicians must be mindful of the limitations of the THV they implant and whether patients can be safely treated by another transcatheter approach, such as valve-in-valve, if a THV fails years later”
 
Jean-François Obadia,  Louis Pradel Hospital Lyon, France
 
  • “I am a surgeon who is involved in the TAVR program, and if TAVR succeeds, I will be very happy for the patient, it will be fantastic. The problem is that we do not know where we are going without evidence of the long-term durability, we are blind”
  •  “This signal of degenerating valves shows that we should be cautious expanding the indication to younger patients”
  • Confronted with the position that manufacturers will surely fix the problems, Obadia told Medical Device Daily: “..They can modify the valve stent to fit better, they can put skirts on it to prevent leaks, but the leaflets will be the same on new valves as they are on the old devices. They do not change, so we cannot expect a better long-term durability for the next generation valves..”
This represents the first insight on the long-term durability of TAVI devices which may have important implications for the surgical AVR market should these findings be confirmed by further studies. While new data will become available to clarify the topic of durability of TAVR vs SAVR and its impact on lower risk patients  it is important to get familiar with the upcoming evidences to cautiously bring into conversation between doctor & patient.