Edwards Benchmark Treatment Pathway for TAVR Evaluated in European Registry

May 17, 2023—Edwards Lifesciences announced that new data from the BENCHMARK registry in Europe demonstrated the safety and effectiveness of a streamlined treatment pathway for patients receiving transcatheter aortic valve replacement (TAVR) with balloon-expandable valves.

According to the company, the Edwards Benchmark program standardizes a minimalist approach to TAVR with a focus on conscious sedation, recovery outside the intensive care unit (ICU), and a goal of next-day discharge that unlocks the benefits of TAVR’s less invasive nature while preserving patient outcomes.

Benchmark best practices include communication, patient and staff education, decision making, and clinical procedures. It is currently being utilized in more than 320 centers in the United States, Europe, Australia, Canada, Korea, and New Zealand. More information on the Edwards Benchmark program is available at www.heartvalves.com/gb.

The study observed 2,405 patients who underwent TAVR with a balloon-expandable valve at 28 sites in seven European countries to determine if implementing a set of tailored Benchmark practices could improve hospital length of stay (LoS), ICU bed occupancy, and patient and staff satisfaction while preserving patient safety.

The data were presented in a late-breaking clinical data session at the EuroPCR conference held May 16-19 in Paris, France.

Edwards reported that patients undergoing TAVR experienced a 25% reduction in ICU stay and a 33% reduction in the median hospital LoS at 30 days versus those before the implementation of the Benchmark pathway with no loss of patient safety. Thirty-day clinical outcomes were similar before and after implementation of the pathway.

As noted in the press release, the investigators concluded that a wider implementation of Benchmark best practices will make the TAVR pathway more efficient without compromising patient safety. Additionally, the study results reflected high patient satisfaction with all elements of the Benchmark practices, scoring > 90% in postprocedure patient satisfaction surveys.

Professor Derk Frank, MD, Head of Cardiology at University Hospital Schleswig-Holstein, in Kiel, Germany, commented in the company’s press release, “The results of this study validate the Edwards Benchmark program as an important tool in reducing the variation in clinical pathways for patients undergoing [TAVR] across Europe. Our results indicate significant improvements in efficiency without compromising patient safety.”

The company noted that an economic analysis by the PARTNER 3 trial investigators identified TAVR as an “economically dominant” strategy to surgical aortic valve replacement among low-risk patients and recognized the potential for greater efficiencies with the continued evolution of minimalist TAVR procedures. On May 8, 2023, the economic analysis findings were published by Benjamin Z. Galper, MD, et al online ahead of print Circulation.

Additionally, a minimalist TAVR pathway (compared to standard TAVR from the SAPIEN 3 Intermediate Risk Registry) was shown to be associated with potential cost savings of $11,000 per case during the index hospitalization. Those findings from the 3MTAVR Economic Study were published by Neel Butala, MD, et al online in Circulation: Cardiovascular Interventions in October 2022.