New Cardiac Care Guidelines Emphasize Simplified and Accessible Approach to Treating Valve Disease

Strategic Insights -

European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery have published new guidelines for the treatment of valve disease, emphasizing a more uniform and simplified approach to treatments, especially with the increasing prevalence of transcatheter aortic valve replacements (TAVR) over open surgeries on the continent. The guidelines, based on recent findings from randomized, controlled trials across the aortic, mitral, and tricuspid valves, recommend earlier consideration of TAVR procedures for patients, with an age cutoff revised to 70 years from 75. Surgical treatments are now recommended for people under 70, with low risk for the procedure.

Key Takeaways:

  • New cardiac care guidelines published by the ESC and the European Association for Cardio-Thoracic Surgery emphasize a more uniform and simplified approach to treating valve disease, especially with the increasing prevalence of TAVR over open surgeries.
  • The guidelines recommend earlier consideration of TAVR procedures for patients, with an age cutoff revised to 70 years from 75.
  • Surgical treatments are now recommended for people under 70, with low risk for the procedure.
  • The guidelines also recommend patients with complex health needs be treated by multidisciplinary teams in high-volume specialty centers.
  • Recommendations include considering TAVR procedures earlier in life, with an age cutoff revised to 70 years, down from 75.
  • Surgeons now recommend surgical treatments for people under 70, if their risk for the procedure is low.
  • The guidelines aim to reduce under-treatment, especially in the elderly, to unnecessary healthcare resource use and shortened lifespan.
  • Valvemakers such as Edwards Lifesciences welcome the changes, which they say are a "meaningful step forward from the prior practice of 'watchful waiting'."
  • Edwards also presented new data for its Evoque TAVR system, showing it reduced heart failure hospitalizations among the most severe tricuspid regurgitation patients after 18 months.
  • Abbott announced an expanded CE mark for its Navitor TAVR system, broadening its reach among symptomatic patients with severe aortic stenosis to include those at low or intermediate risk levels for open surgery.
  • Medtronic reported positive results for its Evolut valves in redo-TAVR procedures among patients at high risk for open-heart surgery.
  • Researchers presented data on a minimalist approach to performing TAVR procedures, showing that using local anesthesia without sedation was noninferior to standard protocols among a combined primary endpoint measuring cardiovascular events, strokes, infections, and other complications after 30 days.

Statistics:

  • 2.3% rate of all-cause mortality and cases of disabling stroke within one year for patients who received Abbott's Navitor TAVR system.
  • 15.4% of patients who received Boston Scientific's Acurate neo2 valve logged an event in the combined study endpoint.
  • 30.4% of patients in the Evolut arm logged an event in the combined study endpoint.
  • 80% of patients can be safely managed with the minimalist approach.
  • 262 patients demonstrated the rate of all-cause mortality and cases of disabling stroke within one year for Abbott's Navitor TAVR system.
  • Up to 50% of younger patients with aortic stenosis will also get coronary artery disease in later years.

Sources:

  • European Society of Cardiology (ESC)
  • European Association for Cardio-Thoracic Surgery
  • Edwards Lifesciences
  • Abbott
  • Medtronic
  • Boston Scientific
  • Rubio and Lopez - Mitral Valve - Guidelines - Aortic Valve Replacement ( PDF )