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Patient engagement

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Listen to a clinical trial patient speak with doctors on the importance of representation in research

Health disparities in the treatment of patients with heart valve disease

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Women are under-diagnosed and under-treated for heart valve disease1

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 Low income patients have less access to advanced cardiac procedures2

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Women are less likely than men to receive treatment for symptomatic severe aortic stenosis (AS)3

Different risk profiles.

Different treatment outcomes.

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With your help participating in clinical trials, we can explore whether a treatment approach or device is safe and effective. Data show that women are getting referred less often than men4, and increasing female participation is critical to improving our understanding about the effects of new treatments for women and saving lives.

We need you.

It is important for researchers to know if certain factors inside and outside the body can affect how well a treatment works and how safe it is in a clinical trial. These factors include:

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Race

Ethnicity

Ethnicity

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Sex

Leaf

Lifestyle

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Age

DNA

Genetic background

Did you know?

1

Racial disparities in TAVR implantation results from several factors, including socioeconomic disparities, inherent biases in healthcare provision, fewer referrals to specialists and language barriers in some minority populations.2

2

Patients who are women, black, or on Medicaid are less likely to be screened for progression of valvular heart disease at appropriate intervals.8

3

Indigenous populations are particularly underrepresented in clinical trials at a disproportionately low level.10

More participation from traditionally underserved communities is needed

Representation across 178 cardiovascular clinical trials9

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We're here for you

We are committed to providing the highest levels of customer service to help our patients improve their quality of life. For any questions, please contact the Edwards Patient Support Center.

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References

  1. WomenHeart. Heart valve disease – why we under-diagnose and under-treat women. Accessed August 24, 2021. https://www.womenheart.org/heart-valve-disease
  2. Bob-Manuel T, Sharma A, Nanda A, et al. A review of racial disparities in transcatheter aortic valve replacement (TAVR): accessibility, referrals and implantation. Ann Transl Med. 2018;6(1). doi:10.21037/atm.2017.10.17
  3. Lowenstern A, Sheridan P, Wang TY, Boero I, Vemulapalli S, Thourani VH, Leon MB, Peterson ED, Brennan JM. Sex disparities in patients with symptomatic severe aortic stenosis. American Heart Journal. 2021 Jul 1;237:116-26.
  4. Michos ED, Reddy TK, Gulati M, Brewer LC, Bond RM, Velarde GP, Bailey AL, Echols MR, Nasser SA, Bays HE, Navar AM. Improving the enrollment of women and racially/ethnically diverse populations in cardiovascular clinical trials: An ASPC practice statement. American Journal of Preventive Cardiology. 2021 Aug 20:100250.
  5. Nitsche C, Koschutnik M, Kammerlander A, Hengstenberg C, Mascherbauer J. Gender-specific differences in valvular heart disease. Wiener klinische Wochenschrift. 2020 Feb;132(3):61-8.
  6. Aggarwal SR, Clavel MA, Messika-Zeitoun D, Cueff C, Malouf J, Araoz PA, Mankad R, Michelena H, Vahanian A, Enriquez-Sarano M. Sex differences in aortic valve calcification measured by multidetector computed tomography in aortic stenosis. Circulation: Cardiovascular Imaging. 2013 Jan;6(1):40-7.
  7. Caponcello MG, Banderas LM, Ferrero C, Bramlage C, Thoenes M, Bramlage P. Gender differences in aortic valve replacement: is surgical aortic valve replacement riskier and transcatheter aortic valve replacement safer in women than in men?. Journal of Thoracic Disease. 2020 Jul;12(7):3737.
  8. Lindman BR, Arnold SV, Bagur R, Clarke L, Coylewright M, Evans F, Hung J, Lauck SB, Peschin S, Sachdev V, Tate LM. Priorities for Patient‐Centered Research in Valvular Heart Disease: A Report From the National Heart, Lung, and Blood Institute Working Group. Journal of the American Heart Association. 2020 May 5;9(9):e015975.
  9. Preventza O, Critsinelis A, Simpson K, Olive JK, LeMaire SA, Cornwell LD, Jimenez E, Byrne J, Chatterjee S, Rosengart TK, Coselli JS. Sex, racial, and ethnic disparities in US cardiovascular trials in more than 230,000 patients. The Annals of Thoracic Surgery. 2021 Sep 1;112(3):726-35.
  10. Mainous AG, Kelliher A, Warne D. Recruiting Indigenous Patients Into Clinical Trials: A Circle of Trust. The Annals of Family Medicine January 2023, 21 (1) 54-56; DOI: https://doi.org/10.1370/afm.2901