Durability

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Jonathon Leipsic - One of the best experts on this subject based on the ideXlab platform.

  • long term Durability of transcatheter heart valves insights from bench testing to 25 years
    Jacc-cardiovascular Interventions, 2020
    Co-Authors: Janarthanan Sathananthan, Mark Hensey, Uri Landes, Abdullah Alkhodair, Adeeb Saiduddin, Anson Cheung, Sandra Lauck, Stephanie L. Sellers, Philipp Blanke, Jonathon Leipsic
    Abstract:

    Abstract Objectives This study assessed the long-term Durability of nominally deployed transcatheter heart valves (THV) to 1 billion cycles (equivalent to 25 years) and non-nominal (overexpansion, underexpansion, and elliptical) THV deployments to 200 million cycles (equivalent to 5 years) with accelerated wear testing. Background The long-term Durability of THVs is currently unknown. As transcatheter aortic valve replacement expands to lower-risk patients, Durability will be of increasing importance. Methods SAPIEN 3 THVs, sized 20, 23, 26, and 29 mm were assessed. Nominally deployed THVs underwent hydrodynamic performance and mechanical Durability as assessed with accelerated wear testing to 1 billion cycles. Magna Ease surgical valves were used as comparators. Durability of non-nominal THV deployments was tested to 200 million cycles. Valves were tested to International Standards Organization 5840:2013 standard. Results THV Durability was excellent for both the nominal and non-nominal THV deployments to 1 billion and 200 million cycles, respectively. At 1 billion cycles the regurgitant fraction for the 20-, 23-, 26-, and 29-mm SAPIEN 3 was 0.92 ± 0.47%, 1.29 ± 0.04%, 1.73 ± 0.46%, and 2.47 ± 0.15%, respectively. There was also excellent Durability in the comparator Magna Ease valves. The regurgitant fraction of non-nominal overexpanded (20 mm, 4.36 ± 0.53; 23 mm, 7.68 ± 1.39; 26 mm, 6.80 ± 1.17; 29 mm, 9.00 ± 0.37), underexpanded (20 mm, 3.06 ± 0.28; 23 mm, 4.46 ± 0.45; 26 mm, 7.72 ± 0.48; 29 mm, 8.65 ± 2.01), and elliptical (20 mm, 3.30 ± 0.38; 23 mm, 6.13 ± 0.94; 26 mm, 6.77 ± 1.22; 29 mm, 8.72 ± 0.24) THVs were excellent at 200 million cycles. Conclusions Nominal SAPIEN 3 THVs demonstrated excellent Durability, to an equivalent of 25-years wear. THV Durability was similar to the comparator surgical valves tested. Non-nominal (overexpansion, underexpansion, and elliptical) THV deployments also had excellent Durability to an equivalent of 5 years wear.

  • tct 736 long term Durability of transcatheter heart valves insights from bench testing to 25 years
    Journal of the American College of Cardiology, 2019
    Co-Authors: Janarthanan Sathananthan, Mark Hensey, Uri Landes, Abdullah Alkhodair, Adeeb Saiduddin, Anson Cheung, Sandra Lauck, Stephanie L. Sellers, Philipp Blanke, Jonathon Leipsic
    Abstract:

    The long-term Durability of transcatheter heart valves (THVs) is currently unknown. As transcatheter aortic valve replacement expands to lower risk patients, Durability will be of increasing importance. This study assessed the long-term Durability of nominally deployed THVs to 1 billion cycles (

Janarthanan Sathananthan - One of the best experts on this subject based on the ideXlab platform.

  • long term Durability of transcatheter heart valves insights from bench testing to 25 years
    Jacc-cardiovascular Interventions, 2020
    Co-Authors: Janarthanan Sathananthan, Mark Hensey, Uri Landes, Abdullah Alkhodair, Adeeb Saiduddin, Anson Cheung, Sandra Lauck, Stephanie L. Sellers, Philipp Blanke, Jonathon Leipsic
    Abstract:

    Abstract Objectives This study assessed the long-term Durability of nominally deployed transcatheter heart valves (THV) to 1 billion cycles (equivalent to 25 years) and non-nominal (overexpansion, underexpansion, and elliptical) THV deployments to 200 million cycles (equivalent to 5 years) with accelerated wear testing. Background The long-term Durability of THVs is currently unknown. As transcatheter aortic valve replacement expands to lower-risk patients, Durability will be of increasing importance. Methods SAPIEN 3 THVs, sized 20, 23, 26, and 29 mm were assessed. Nominally deployed THVs underwent hydrodynamic performance and mechanical Durability as assessed with accelerated wear testing to 1 billion cycles. Magna Ease surgical valves were used as comparators. Durability of non-nominal THV deployments was tested to 200 million cycles. Valves were tested to International Standards Organization 5840:2013 standard. Results THV Durability was excellent for both the nominal and non-nominal THV deployments to 1 billion and 200 million cycles, respectively. At 1 billion cycles the regurgitant fraction for the 20-, 23-, 26-, and 29-mm SAPIEN 3 was 0.92 ± 0.47%, 1.29 ± 0.04%, 1.73 ± 0.46%, and 2.47 ± 0.15%, respectively. There was also excellent Durability in the comparator Magna Ease valves. The regurgitant fraction of non-nominal overexpanded (20 mm, 4.36 ± 0.53; 23 mm, 7.68 ± 1.39; 26 mm, 6.80 ± 1.17; 29 mm, 9.00 ± 0.37), underexpanded (20 mm, 3.06 ± 0.28; 23 mm, 4.46 ± 0.45; 26 mm, 7.72 ± 0.48; 29 mm, 8.65 ± 2.01), and elliptical (20 mm, 3.30 ± 0.38; 23 mm, 6.13 ± 0.94; 26 mm, 6.77 ± 1.22; 29 mm, 8.72 ± 0.24) THVs were excellent at 200 million cycles. Conclusions Nominal SAPIEN 3 THVs demonstrated excellent Durability, to an equivalent of 25-years wear. THV Durability was similar to the comparator surgical valves tested. Non-nominal (overexpansion, underexpansion, and elliptical) THV deployments also had excellent Durability to an equivalent of 5 years wear.

  • tct 736 long term Durability of transcatheter heart valves insights from bench testing to 25 years
    Journal of the American College of Cardiology, 2019
    Co-Authors: Janarthanan Sathananthan, Mark Hensey, Uri Landes, Abdullah Alkhodair, Adeeb Saiduddin, Anson Cheung, Sandra Lauck, Stephanie L. Sellers, Philipp Blanke, Jonathon Leipsic
    Abstract:

    The long-term Durability of transcatheter heart valves (THVs) is currently unknown. As transcatheter aortic valve replacement expands to lower risk patients, Durability will be of increasing importance. This study assessed the long-term Durability of nominally deployed THVs to 1 billion cycles (

Philipp Blanke - One of the best experts on this subject based on the ideXlab platform.

  • long term Durability of transcatheter heart valves insights from bench testing to 25 years
    Jacc-cardiovascular Interventions, 2020
    Co-Authors: Janarthanan Sathananthan, Mark Hensey, Uri Landes, Abdullah Alkhodair, Adeeb Saiduddin, Anson Cheung, Sandra Lauck, Stephanie L. Sellers, Philipp Blanke, Jonathon Leipsic
    Abstract:

    Abstract Objectives This study assessed the long-term Durability of nominally deployed transcatheter heart valves (THV) to 1 billion cycles (equivalent to 25 years) and non-nominal (overexpansion, underexpansion, and elliptical) THV deployments to 200 million cycles (equivalent to 5 years) with accelerated wear testing. Background The long-term Durability of THVs is currently unknown. As transcatheter aortic valve replacement expands to lower-risk patients, Durability will be of increasing importance. Methods SAPIEN 3 THVs, sized 20, 23, 26, and 29 mm were assessed. Nominally deployed THVs underwent hydrodynamic performance and mechanical Durability as assessed with accelerated wear testing to 1 billion cycles. Magna Ease surgical valves were used as comparators. Durability of non-nominal THV deployments was tested to 200 million cycles. Valves were tested to International Standards Organization 5840:2013 standard. Results THV Durability was excellent for both the nominal and non-nominal THV deployments to 1 billion and 200 million cycles, respectively. At 1 billion cycles the regurgitant fraction for the 20-, 23-, 26-, and 29-mm SAPIEN 3 was 0.92 ± 0.47%, 1.29 ± 0.04%, 1.73 ± 0.46%, and 2.47 ± 0.15%, respectively. There was also excellent Durability in the comparator Magna Ease valves. The regurgitant fraction of non-nominal overexpanded (20 mm, 4.36 ± 0.53; 23 mm, 7.68 ± 1.39; 26 mm, 6.80 ± 1.17; 29 mm, 9.00 ± 0.37), underexpanded (20 mm, 3.06 ± 0.28; 23 mm, 4.46 ± 0.45; 26 mm, 7.72 ± 0.48; 29 mm, 8.65 ± 2.01), and elliptical (20 mm, 3.30 ± 0.38; 23 mm, 6.13 ± 0.94; 26 mm, 6.77 ± 1.22; 29 mm, 8.72 ± 0.24) THVs were excellent at 200 million cycles. Conclusions Nominal SAPIEN 3 THVs demonstrated excellent Durability, to an equivalent of 25-years wear. THV Durability was similar to the comparator surgical valves tested. Non-nominal (overexpansion, underexpansion, and elliptical) THV deployments also had excellent Durability to an equivalent of 5 years wear.

  • tct 736 long term Durability of transcatheter heart valves insights from bench testing to 25 years
    Journal of the American College of Cardiology, 2019
    Co-Authors: Janarthanan Sathananthan, Mark Hensey, Uri Landes, Abdullah Alkhodair, Adeeb Saiduddin, Anson Cheung, Sandra Lauck, Stephanie L. Sellers, Philipp Blanke, Jonathon Leipsic
    Abstract:

    The long-term Durability of transcatheter heart valves (THVs) is currently unknown. As transcatheter aortic valve replacement expands to lower risk patients, Durability will be of increasing importance. This study assessed the long-term Durability of nominally deployed THVs to 1 billion cycles (

Stephanie L. Sellers - One of the best experts on this subject based on the ideXlab platform.

  • long term Durability of transcatheter heart valves insights from bench testing to 25 years
    Jacc-cardiovascular Interventions, 2020
    Co-Authors: Janarthanan Sathananthan, Mark Hensey, Uri Landes, Abdullah Alkhodair, Adeeb Saiduddin, Anson Cheung, Sandra Lauck, Stephanie L. Sellers, Philipp Blanke, Jonathon Leipsic
    Abstract:

    Abstract Objectives This study assessed the long-term Durability of nominally deployed transcatheter heart valves (THV) to 1 billion cycles (equivalent to 25 years) and non-nominal (overexpansion, underexpansion, and elliptical) THV deployments to 200 million cycles (equivalent to 5 years) with accelerated wear testing. Background The long-term Durability of THVs is currently unknown. As transcatheter aortic valve replacement expands to lower-risk patients, Durability will be of increasing importance. Methods SAPIEN 3 THVs, sized 20, 23, 26, and 29 mm were assessed. Nominally deployed THVs underwent hydrodynamic performance and mechanical Durability as assessed with accelerated wear testing to 1 billion cycles. Magna Ease surgical valves were used as comparators. Durability of non-nominal THV deployments was tested to 200 million cycles. Valves were tested to International Standards Organization 5840:2013 standard. Results THV Durability was excellent for both the nominal and non-nominal THV deployments to 1 billion and 200 million cycles, respectively. At 1 billion cycles the regurgitant fraction for the 20-, 23-, 26-, and 29-mm SAPIEN 3 was 0.92 ± 0.47%, 1.29 ± 0.04%, 1.73 ± 0.46%, and 2.47 ± 0.15%, respectively. There was also excellent Durability in the comparator Magna Ease valves. The regurgitant fraction of non-nominal overexpanded (20 mm, 4.36 ± 0.53; 23 mm, 7.68 ± 1.39; 26 mm, 6.80 ± 1.17; 29 mm, 9.00 ± 0.37), underexpanded (20 mm, 3.06 ± 0.28; 23 mm, 4.46 ± 0.45; 26 mm, 7.72 ± 0.48; 29 mm, 8.65 ± 2.01), and elliptical (20 mm, 3.30 ± 0.38; 23 mm, 6.13 ± 0.94; 26 mm, 6.77 ± 1.22; 29 mm, 8.72 ± 0.24) THVs were excellent at 200 million cycles. Conclusions Nominal SAPIEN 3 THVs demonstrated excellent Durability, to an equivalent of 25-years wear. THV Durability was similar to the comparator surgical valves tested. Non-nominal (overexpansion, underexpansion, and elliptical) THV deployments also had excellent Durability to an equivalent of 5 years wear.

  • tct 736 long term Durability of transcatheter heart valves insights from bench testing to 25 years
    Journal of the American College of Cardiology, 2019
    Co-Authors: Janarthanan Sathananthan, Mark Hensey, Uri Landes, Abdullah Alkhodair, Adeeb Saiduddin, Anson Cheung, Sandra Lauck, Stephanie L. Sellers, Philipp Blanke, Jonathon Leipsic
    Abstract:

    The long-term Durability of transcatheter heart valves (THVs) is currently unknown. As transcatheter aortic valve replacement expands to lower risk patients, Durability will be of increasing importance. This study assessed the long-term Durability of nominally deployed THVs to 1 billion cycles (

Sandra Lauck - One of the best experts on this subject based on the ideXlab platform.

  • long term Durability of transcatheter heart valves insights from bench testing to 25 years
    Jacc-cardiovascular Interventions, 2020
    Co-Authors: Janarthanan Sathananthan, Mark Hensey, Uri Landes, Abdullah Alkhodair, Adeeb Saiduddin, Anson Cheung, Sandra Lauck, Stephanie L. Sellers, Philipp Blanke, Jonathon Leipsic
    Abstract:

    Abstract Objectives This study assessed the long-term Durability of nominally deployed transcatheter heart valves (THV) to 1 billion cycles (equivalent to 25 years) and non-nominal (overexpansion, underexpansion, and elliptical) THV deployments to 200 million cycles (equivalent to 5 years) with accelerated wear testing. Background The long-term Durability of THVs is currently unknown. As transcatheter aortic valve replacement expands to lower-risk patients, Durability will be of increasing importance. Methods SAPIEN 3 THVs, sized 20, 23, 26, and 29 mm were assessed. Nominally deployed THVs underwent hydrodynamic performance and mechanical Durability as assessed with accelerated wear testing to 1 billion cycles. Magna Ease surgical valves were used as comparators. Durability of non-nominal THV deployments was tested to 200 million cycles. Valves were tested to International Standards Organization 5840:2013 standard. Results THV Durability was excellent for both the nominal and non-nominal THV deployments to 1 billion and 200 million cycles, respectively. At 1 billion cycles the regurgitant fraction for the 20-, 23-, 26-, and 29-mm SAPIEN 3 was 0.92 ± 0.47%, 1.29 ± 0.04%, 1.73 ± 0.46%, and 2.47 ± 0.15%, respectively. There was also excellent Durability in the comparator Magna Ease valves. The regurgitant fraction of non-nominal overexpanded (20 mm, 4.36 ± 0.53; 23 mm, 7.68 ± 1.39; 26 mm, 6.80 ± 1.17; 29 mm, 9.00 ± 0.37), underexpanded (20 mm, 3.06 ± 0.28; 23 mm, 4.46 ± 0.45; 26 mm, 7.72 ± 0.48; 29 mm, 8.65 ± 2.01), and elliptical (20 mm, 3.30 ± 0.38; 23 mm, 6.13 ± 0.94; 26 mm, 6.77 ± 1.22; 29 mm, 8.72 ± 0.24) THVs were excellent at 200 million cycles. Conclusions Nominal SAPIEN 3 THVs demonstrated excellent Durability, to an equivalent of 25-years wear. THV Durability was similar to the comparator surgical valves tested. Non-nominal (overexpansion, underexpansion, and elliptical) THV deployments also had excellent Durability to an equivalent of 5 years wear.

  • tct 736 long term Durability of transcatheter heart valves insights from bench testing to 25 years
    Journal of the American College of Cardiology, 2019
    Co-Authors: Janarthanan Sathananthan, Mark Hensey, Uri Landes, Abdullah Alkhodair, Adeeb Saiduddin, Anson Cheung, Sandra Lauck, Stephanie L. Sellers, Philipp Blanke, Jonathon Leipsic
    Abstract:

    The long-term Durability of transcatheter heart valves (THVs) is currently unknown. As transcatheter aortic valve replacement expands to lower risk patients, Durability will be of increasing importance. This study assessed the long-term Durability of nominally deployed THVs to 1 billion cycles (