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John A Coller - One of the best experts on this subject based on the ideXlab platform.
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long term Durability of sacral nerve stimulation therapy for chronic fecal incontinence
Diseases of The Colon & Rectum, 2013Co-Authors: Tracy Hull, Chad Giese, Steven D Wexner, Anders F Mellgren, Ghislain Devroede, Robert D Madoff, Katherine Stromberg, John A CollerAbstract:BACKGROUND: Limited data have been published regarding the Long-Term results of sacral nerve stimulation, or sacral neuromodulation, for severe fecal incontinence. OBJECTIVES: The aim was to assess the outcome of sacral nerve stimulation with the use of precise tools and data collection, focusing on the Long-Term Durability of the therapy. Five-year data were analyzed. DESIGN: Patients entered in a multicenter, prospective study for fecal incontinence were followed at 3, 6, and 12 months and annually after device implantation. PATIENTS: Patients with chronic fecal incontinence in whom conservative treatments had failed or who were not candidates for more conservative treatments were selected. INTERVENTIONS: Patients with ≥ 50% improvement over baseline in fecal incontinence episodes per week during a 14-day test stimulation period received sacral nerve stimulation therapy. MAIN OUTCOME MEASURES: Patients were assessed with a 14-day bowel diary and Fecal Incontinence Quality of Life and Fecal Incontinence Severity Index questionnaires. Therapeutic success was defined as ≥ 50% improvement over baseline in fecal incontinence episodes per week. All adverse events were collected. RESULTS: A total of 120 patients (110 women; mean age, 60.5 years) underwent implantation. Seventy-six of these patients (63%) were followed a minimum of 5 years (maximum, longer than 8 years) and are the basis for this report. Fecal incontinence episodes per week decreased from a mean of 9.1 at baseline to 1.7 at 5 years, with 89% (n = 64/72) having ≥ 50% improvement (p < 0.0001) and 36% (n = 26/72) having complete continence. Fecal Incontinence Quality of Life scores also significantly improved for all 4 scales between baseline and 5 years (n = 70; p < 0.0001). Twenty-seven of the 76 (35.5%) patients required a device revision, replacement, or explant. CONCLUSIONS: The therapeutic effect and improved quality of life for fecal incontinence is maintained 5 years after sacral nerve stimulation implantation and beyond. Device revision, replacement, or explant rate was acceptable, but future efforts should be aimed at improvement.
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long term Durability of sacral nerve stimulation therapy for chronic fecal incontinence
Diseases of The Colon & Rectum, 2013Co-Authors: Tracy L Hull, Chad Giese, Steven D Wexner, Ghislain Devroede, Robert D Madoff, Katherine Stromberg, Anders Mellgren, John A CollerAbstract:BACKGROUND:Limited data have been published regarding the Long-Term results of sacral nerve stimulation, or sacral neuromodulation, for severe fecal incontinence.OBJECTIVES:The aim was to assess the outcome of sacral nerve stimulation with the use of precise tools and data collection, focusing on th
Jonathon Leipsic - One of the best experts on this subject based on the ideXlab platform.
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long term Durability of transcatheter heart valves insights from bench testing to 25 years
Jacc-cardiovascular Interventions, 2020Co-Authors: Janarthanan Sathananthan, Mark Hensey, Uri Landes, Abdullah Alkhodair, Adeeb Saiduddin, Anson Cheung, Sandra Lauck, Stephanie L. Sellers, Philipp Blanke, Jonathon LeipsicAbstract: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.
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tct 736 long term Durability of transcatheter heart valves insights from bench testing to 25 years
Journal of the American College of Cardiology, 2019Co-Authors: Janarthanan Sathananthan, Mark Hensey, Uri Landes, Abdullah Alkhodair, Adeeb Saiduddin, Anson Cheung, Sandra Lauck, Stephanie L. Sellers, Philipp Blanke, Jonathon LeipsicAbstract: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 (
Katherine Stromberg - One of the best experts on this subject based on the ideXlab platform.
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long term Durability of sacral nerve stimulation therapy for chronic fecal incontinence
Diseases of The Colon & Rectum, 2013Co-Authors: Tracy Hull, Chad Giese, Steven D Wexner, Anders F Mellgren, Ghislain Devroede, Robert D Madoff, Katherine Stromberg, John A CollerAbstract:BACKGROUND: Limited data have been published regarding the Long-Term results of sacral nerve stimulation, or sacral neuromodulation, for severe fecal incontinence. OBJECTIVES: The aim was to assess the outcome of sacral nerve stimulation with the use of precise tools and data collection, focusing on the Long-Term Durability of the therapy. Five-year data were analyzed. DESIGN: Patients entered in a multicenter, prospective study for fecal incontinence were followed at 3, 6, and 12 months and annually after device implantation. PATIENTS: Patients with chronic fecal incontinence in whom conservative treatments had failed or who were not candidates for more conservative treatments were selected. INTERVENTIONS: Patients with ≥ 50% improvement over baseline in fecal incontinence episodes per week during a 14-day test stimulation period received sacral nerve stimulation therapy. MAIN OUTCOME MEASURES: Patients were assessed with a 14-day bowel diary and Fecal Incontinence Quality of Life and Fecal Incontinence Severity Index questionnaires. Therapeutic success was defined as ≥ 50% improvement over baseline in fecal incontinence episodes per week. All adverse events were collected. RESULTS: A total of 120 patients (110 women; mean age, 60.5 years) underwent implantation. Seventy-six of these patients (63%) were followed a minimum of 5 years (maximum, longer than 8 years) and are the basis for this report. Fecal incontinence episodes per week decreased from a mean of 9.1 at baseline to 1.7 at 5 years, with 89% (n = 64/72) having ≥ 50% improvement (p < 0.0001) and 36% (n = 26/72) having complete continence. Fecal Incontinence Quality of Life scores also significantly improved for all 4 scales between baseline and 5 years (n = 70; p < 0.0001). Twenty-seven of the 76 (35.5%) patients required a device revision, replacement, or explant. CONCLUSIONS: The therapeutic effect and improved quality of life for fecal incontinence is maintained 5 years after sacral nerve stimulation implantation and beyond. Device revision, replacement, or explant rate was acceptable, but future efforts should be aimed at improvement.
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long term Durability of sacral nerve stimulation therapy for chronic fecal incontinence
Diseases of The Colon & Rectum, 2013Co-Authors: Tracy L Hull, Chad Giese, Steven D Wexner, Ghislain Devroede, Robert D Madoff, Katherine Stromberg, Anders Mellgren, John A CollerAbstract:BACKGROUND:Limited data have been published regarding the Long-Term results of sacral nerve stimulation, or sacral neuromodulation, for severe fecal incontinence.OBJECTIVES:The aim was to assess the outcome of sacral nerve stimulation with the use of precise tools and data collection, focusing on th
Chad Giese - One of the best experts on this subject based on the ideXlab platform.
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long term Durability of sacral nerve stimulation therapy for chronic fecal incontinence
Diseases of The Colon & Rectum, 2013Co-Authors: Tracy Hull, Chad Giese, Steven D Wexner, Anders F Mellgren, Ghislain Devroede, Robert D Madoff, Katherine Stromberg, John A CollerAbstract:BACKGROUND: Limited data have been published regarding the Long-Term results of sacral nerve stimulation, or sacral neuromodulation, for severe fecal incontinence. OBJECTIVES: The aim was to assess the outcome of sacral nerve stimulation with the use of precise tools and data collection, focusing on the Long-Term Durability of the therapy. Five-year data were analyzed. DESIGN: Patients entered in a multicenter, prospective study for fecal incontinence were followed at 3, 6, and 12 months and annually after device implantation. PATIENTS: Patients with chronic fecal incontinence in whom conservative treatments had failed or who were not candidates for more conservative treatments were selected. INTERVENTIONS: Patients with ≥ 50% improvement over baseline in fecal incontinence episodes per week during a 14-day test stimulation period received sacral nerve stimulation therapy. MAIN OUTCOME MEASURES: Patients were assessed with a 14-day bowel diary and Fecal Incontinence Quality of Life and Fecal Incontinence Severity Index questionnaires. Therapeutic success was defined as ≥ 50% improvement over baseline in fecal incontinence episodes per week. All adverse events were collected. RESULTS: A total of 120 patients (110 women; mean age, 60.5 years) underwent implantation. Seventy-six of these patients (63%) were followed a minimum of 5 years (maximum, longer than 8 years) and are the basis for this report. Fecal incontinence episodes per week decreased from a mean of 9.1 at baseline to 1.7 at 5 years, with 89% (n = 64/72) having ≥ 50% improvement (p < 0.0001) and 36% (n = 26/72) having complete continence. Fecal Incontinence Quality of Life scores also significantly improved for all 4 scales between baseline and 5 years (n = 70; p < 0.0001). Twenty-seven of the 76 (35.5%) patients required a device revision, replacement, or explant. CONCLUSIONS: The therapeutic effect and improved quality of life for fecal incontinence is maintained 5 years after sacral nerve stimulation implantation and beyond. Device revision, replacement, or explant rate was acceptable, but future efforts should be aimed at improvement.
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long term Durability of sacral nerve stimulation therapy for chronic fecal incontinence
Diseases of The Colon & Rectum, 2013Co-Authors: Tracy L Hull, Chad Giese, Steven D Wexner, Ghislain Devroede, Robert D Madoff, Katherine Stromberg, Anders Mellgren, John A CollerAbstract:BACKGROUND:Limited data have been published regarding the Long-Term results of sacral nerve stimulation, or sacral neuromodulation, for severe fecal incontinence.OBJECTIVES:The aim was to assess the outcome of sacral nerve stimulation with the use of precise tools and data collection, focusing on th
Steven D Wexner - One of the best experts on this subject based on the ideXlab platform.
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long term Durability of sacral nerve stimulation therapy for chronic fecal incontinence
Diseases of The Colon & Rectum, 2013Co-Authors: Tracy Hull, Chad Giese, Steven D Wexner, Anders F Mellgren, Ghislain Devroede, Robert D Madoff, Katherine Stromberg, John A CollerAbstract:BACKGROUND: Limited data have been published regarding the Long-Term results of sacral nerve stimulation, or sacral neuromodulation, for severe fecal incontinence. OBJECTIVES: The aim was to assess the outcome of sacral nerve stimulation with the use of precise tools and data collection, focusing on the Long-Term Durability of the therapy. Five-year data were analyzed. DESIGN: Patients entered in a multicenter, prospective study for fecal incontinence were followed at 3, 6, and 12 months and annually after device implantation. PATIENTS: Patients with chronic fecal incontinence in whom conservative treatments had failed or who were not candidates for more conservative treatments were selected. INTERVENTIONS: Patients with ≥ 50% improvement over baseline in fecal incontinence episodes per week during a 14-day test stimulation period received sacral nerve stimulation therapy. MAIN OUTCOME MEASURES: Patients were assessed with a 14-day bowel diary and Fecal Incontinence Quality of Life and Fecal Incontinence Severity Index questionnaires. Therapeutic success was defined as ≥ 50% improvement over baseline in fecal incontinence episodes per week. All adverse events were collected. RESULTS: A total of 120 patients (110 women; mean age, 60.5 years) underwent implantation. Seventy-six of these patients (63%) were followed a minimum of 5 years (maximum, longer than 8 years) and are the basis for this report. Fecal incontinence episodes per week decreased from a mean of 9.1 at baseline to 1.7 at 5 years, with 89% (n = 64/72) having ≥ 50% improvement (p < 0.0001) and 36% (n = 26/72) having complete continence. Fecal Incontinence Quality of Life scores also significantly improved for all 4 scales between baseline and 5 years (n = 70; p < 0.0001). Twenty-seven of the 76 (35.5%) patients required a device revision, replacement, or explant. CONCLUSIONS: The therapeutic effect and improved quality of life for fecal incontinence is maintained 5 years after sacral nerve stimulation implantation and beyond. Device revision, replacement, or explant rate was acceptable, but future efforts should be aimed at improvement.
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long term Durability of sacral nerve stimulation therapy for chronic fecal incontinence
Diseases of The Colon & Rectum, 2013Co-Authors: Tracy L Hull, Chad Giese, Steven D Wexner, Ghislain Devroede, Robert D Madoff, Katherine Stromberg, Anders Mellgren, John A CollerAbstract:BACKGROUND:Limited data have been published regarding the Long-Term results of sacral nerve stimulation, or sacral neuromodulation, for severe fecal incontinence.OBJECTIVES:The aim was to assess the outcome of sacral nerve stimulation with the use of precise tools and data collection, focusing on th
