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Defining the patient population

All severe, symptomatic aortic stenosis patients are eligible for TAVI.

About this topic

Progressive ageing of a population is associated with an increased prevalence of chronic and degenerative diseases,1 of which the most common disorders are hypertension, dementia2 and cardiovascular diseases (CVDs).3

The age-related increase in CVDs translates to an increased prevalence of valvular heart disease (VHD) in the elderly population.4 A 2016 UK study found that aortic stenosis (AS) was present in 1.3% of individuals aged 65 years and over,5 and a 2006 US study found that this rises to 4.1–5.2% in patients who are over 75 years of age.6 The prevalence of clinically significant VHD is forecasted to double by 2050.5

The most common and only effective treatment for severe symptomatic aortic stenosis (ssAS) is aortic valve replacement, yet it is estimated that one in three of these patients do not undergo treatment.7 Without treatment, the 3-year survival rate is less than 30%.8 With treatment, in patients with AS who are at high surgical risk, a study has shown that health status improves significantly for up to 1 year after transcatheter aortic valve implantation (TAVI), with significant health-related quality of life benefits in elderly patients.9

Seminal studies in 2011,10 201611 and 201912 compared TAVI using the Edwards SAPIEN valve technology with surgical aortic valve replacement (SAVR) for patients with ssAS:

In high-risk patients, transcatheter and surgical procedures had similar rates of survival at 1 year.10
In intermediate-risk patients, at 1 year TAVI was similar to SAVR with respect to the primary endpoint of death or disabling stroke.11 Data from propensity score analysis in intermediate risk patients indicated significant superiority of the SAPIEN 3 TM valve TAVI compared with surgery for composite outcome of all-cause death, all strokes and moderate to severe aortic regurgitation, suggesting that TAVI might be the preferred treatment alternative in intermediate-risk patients.13
In low-risk patients, the rate of the composite of death, stroke or re-hospitalisation at 1 year was significantly lower with TAVI than with surgery.12
 

In high- to medium-risk populations (including those deemed inoperable), there are currently 115,000 patients eligible for TAVI in the EU annually.14 The expansion to younger, low-risk patients has the potential to cause this number to increase to over 180,000 – with major implications for healthcare resource planning.14

The burden to healthcare resources have increased drastically during COVID-19. As a large number of patient care have been placed on hold during the pandemic, tackling this backlog will become a number one priority for most, if not all, acute-care settings.

 

  1. Rostagno C. Heart valve disease in elderly. World J Cardiol 2019;11:71–83
  2. Marengoni A. Prevalence of chronic diseases and multimorbidity among the elderly population in Sweden. Am J Public Health 2008;98:1198–200
  3. Wahl D, et al. Aging, lifestyle and dementia. Neurobiology of Disease 2019;130:104481
  4. Yazdanyar A, et al. The burden of cardiovascular disease in the elderly: Morbidity, Mortality, and Costs. Clin Geriatr Med. 2009;25:563–vii. Doi:10.1016/j.cger.2009.07.007
  5. d’Arcy J, et al. Large-scale community echocardiographic screening reveals major burden of undiagnosed valvular heart disease in older people: the OxVALVE Population Cohort Study. Eur Heart J 2016;37:3515–22.
  6. Nkomo V, et al. Burden of valvular heart disease: a population-based study. Lancet 2006;368:1005–11.
  7. Bach DS, et al. Evaluation of patients with severe symptomatic aortic stenosis who do not undergo aortic valve replacement: The potential role of subjectively overestimated operative risk. Circ Cardiovasc Qual Outcomes 2009;2:533–9.
  8. Spaccarotella C, et al. Pathophysiology of Aortic Stenosis and Approach to Treatment With Percutaneous Valve Implantation. Circ J 2011;75: 11–9.
  9. Elmalem S. Health-related quality of life after transcatheter aortic valve implantation in elderly patients with severe aortic stenosis. Journal of the American Medical Directors Association 2014;15:201–6.
  10. Smith CR, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 2011;364:2187–98.
  11. Leon MB, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med 2016;374:1609–20.
  12. Mack MJ, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med 2019;380:1695–705.
  13. Thourani VH, et al. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis. Lancet 2016;2218–25
  14. Durko AP, et al. Annual number of candidates for transcatheter aortic valve implantation per country: current estimates and future projections. Eur Heart J 2018;0:1–8.
 
This content is sponsored by Edwards Lifesciences