Pulmonary Valved Conduit

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Patrick W. Serruys - One of the best experts on this subject based on the ideXlab platform.

  • Midterm performance of a novel restorative Pulmonary Valved Conduit: preclinical results.
    Eurointervention, 2017
    Co-Authors: Osama Ibrahim Ibrahim Soliman, Mohammad Abdelghani, Marieke Brugmans, Maarten Witsenburg, Yoshinobu Onuma, Yosuke Miyazaki, Patrick W. Serruys
    Abstract:

    Aims: The Xeltis bioabsorbable Pulmonary Valved Conduit (XPV), designed to guide functional restoration of patients' own tissue, is potentially more durable than current Pulmonary bioprosthetic valves/Valved Conduits. The aim of this study was to assess the haemodynamic performance of the novel XPV implanted in an ovine model. Methods and results: The XPV was surgically implanted in adult sheep under general anaesthesia and cardioPulmonary bypass (XPV group, n= 20). Sheep that received a Hancock bioprosthetic Pulmonary Valved Conduit served as a control group (HPV group, n = 3). Transthoracic echocardiograms from VARC-2 recommended time points at 3, 6, 9, 12, 18 and 24 months (XPV group) and at 3 and 6 months (HPV group) after the procedure were analysed in an independent core laboratory. The primary endpoint was favourable Valved Conduit performance, defined as peak systolic pressure gradient

  • midterm performance of a novel restorative Pulmonary Valved Conduit preclinical results
    Eurointervention, 2017
    Co-Authors: Osama Ibrahim Ibrahim Soliman, Mohammad Abdelghani, Marieke Brugmans, Maarten Witsenburg, Yoshinobu Onuma, Yosuke Miyazaki, Patrick W. Serruys
    Abstract:

    Aims: The Xeltis bioabsorbable Pulmonary Valved Conduit (XPV), designed to guide functional restoration of patients' own tissue, is potentially more durable than current Pulmonary bioprosthetic valves/Valved Conduits. The aim of this study was to assess the haemodynamic performance of the novel XPV implanted in an ovine model. Methods and results: The XPV was surgically implanted in adult sheep under general anaesthesia and cardioPulmonary bypass (XPV group, n= 20). Sheep that received a Hancock bioprosthetic Pulmonary Valved Conduit served as a control group (HPV group, n = 3). Transthoracic echocardiograms from VARC-2 recommended time points at 3, 6, 9, 12, 18 and 24 months (XPV group) and at 3 and 6 months (HPV group) after the procedure were analysed in an independent core laboratory. The primary endpoint was favourable Valved Conduit performance, defined as peak systolic pressure gradient <40 mmHg, no severe Pulmonary regurgitation (PR), and a maximum Conduit patency index of -20%. In the latter, negative values denote luminal narrowing and vice versa. The valvular peak systolic pressure gradient (mmHg) was 25.6 +/- 9.7 (3 months), 19.6 +/- 7.1 (6 months), 10.0 +/- 9.2 (24 months) in the XPV group and 18.4 +/- 6.6 (3 months), 17.7 +/- 4.6 (6 months) in the HPV group. The patency index (%) of the Conduit at the valvular level was + 30.3 +/- 13.6 (6 months) and + 64.1 +/- 1.4 (24 months) in the XPV group and + 2.0 +/- 15.9 (6 months) in the HPV group. PR was trace or mild at all visits, except in one animal with persistent moderate PR in the XPV group, up to 24 months. Conclusions: The XPV showed a favourable and durable haemodynamic performance (up to two years after implantation), without Conduit narrowing/obstruction or severe regurgitation

Osama Ibrahim Ibrahim Soliman - One of the best experts on this subject based on the ideXlab platform.

  • Midterm performance of a novel restorative Pulmonary Valved Conduit: preclinical results.
    Eurointervention, 2017
    Co-Authors: Osama Ibrahim Ibrahim Soliman, Mohammad Abdelghani, Marieke Brugmans, Maarten Witsenburg, Yoshinobu Onuma, Yosuke Miyazaki, Patrick W. Serruys
    Abstract:

    Aims: The Xeltis bioabsorbable Pulmonary Valved Conduit (XPV), designed to guide functional restoration of patients' own tissue, is potentially more durable than current Pulmonary bioprosthetic valves/Valved Conduits. The aim of this study was to assess the haemodynamic performance of the novel XPV implanted in an ovine model. Methods and results: The XPV was surgically implanted in adult sheep under general anaesthesia and cardioPulmonary bypass (XPV group, n= 20). Sheep that received a Hancock bioprosthetic Pulmonary Valved Conduit served as a control group (HPV group, n = 3). Transthoracic echocardiograms from VARC-2 recommended time points at 3, 6, 9, 12, 18 and 24 months (XPV group) and at 3 and 6 months (HPV group) after the procedure were analysed in an independent core laboratory. The primary endpoint was favourable Valved Conduit performance, defined as peak systolic pressure gradient

  • midterm performance of a novel restorative Pulmonary Valved Conduit preclinical results
    Eurointervention, 2017
    Co-Authors: Osama Ibrahim Ibrahim Soliman, Mohammad Abdelghani, Marieke Brugmans, Maarten Witsenburg, Yoshinobu Onuma, Yosuke Miyazaki, Patrick W. Serruys
    Abstract:

    Aims: The Xeltis bioabsorbable Pulmonary Valved Conduit (XPV), designed to guide functional restoration of patients' own tissue, is potentially more durable than current Pulmonary bioprosthetic valves/Valved Conduits. The aim of this study was to assess the haemodynamic performance of the novel XPV implanted in an ovine model. Methods and results: The XPV was surgically implanted in adult sheep under general anaesthesia and cardioPulmonary bypass (XPV group, n= 20). Sheep that received a Hancock bioprosthetic Pulmonary Valved Conduit served as a control group (HPV group, n = 3). Transthoracic echocardiograms from VARC-2 recommended time points at 3, 6, 9, 12, 18 and 24 months (XPV group) and at 3 and 6 months (HPV group) after the procedure were analysed in an independent core laboratory. The primary endpoint was favourable Valved Conduit performance, defined as peak systolic pressure gradient <40 mmHg, no severe Pulmonary regurgitation (PR), and a maximum Conduit patency index of -20%. In the latter, negative values denote luminal narrowing and vice versa. The valvular peak systolic pressure gradient (mmHg) was 25.6 +/- 9.7 (3 months), 19.6 +/- 7.1 (6 months), 10.0 +/- 9.2 (24 months) in the XPV group and 18.4 +/- 6.6 (3 months), 17.7 +/- 4.6 (6 months) in the HPV group. The patency index (%) of the Conduit at the valvular level was + 30.3 +/- 13.6 (6 months) and + 64.1 +/- 1.4 (24 months) in the XPV group and + 2.0 +/- 15.9 (6 months) in the HPV group. PR was trace or mild at all visits, except in one animal with persistent moderate PR in the XPV group, up to 24 months. Conclusions: The XPV showed a favourable and durable haemodynamic performance (up to two years after implantation), without Conduit narrowing/obstruction or severe regurgitation

Marieke Brugmans - One of the best experts on this subject based on the ideXlab platform.

  • a novel restorative Pulmonary Valved Conduit in a chronic sheep model mid term hemodynamic function and histologic assessment
    The Journal of Thoracic and Cardiovascular Surgery, 2017
    Co-Authors: Ger B W E Bennink, Marieke Brugmans, Sho Torii, Oleg Svanidze, Thierry Carrel, Elena Ladich, Renu Virmani
    Abstract:

    Abstract Objective To evaluate the safety and the short-term function of a novel Pulmonary Valved Conduit (Xeltis Pulmonary Valved Conduit; XPV) up to 12 months in a sheep model. Methods XPV and Hancock bioprosthetic Valved Conduits (H, used as control) were implanted in adult sheep in the Pulmonary artery position. Animals were killed at 2 months (n = 6 XPV), 6 months (n = 6 XPV and n = 3 H), and 12 months (n = 6 XPV) and examined histologically. During follow-up, function of the device as well as diameter of both XPV and H were assessed by transthoracic echocardiography. Results Of 18 animals that received an XPV, 15 survived until they were killed; 3 animals that received H survived the planned observational interval. XPV showed mild neointimal thickening and degradation beginning at 2 months with an ongoing process until 12 months. Only 1 of the 18 animals with XPV had significant calcification at 6 months. Pathologic specimen did not show any significant narrowing of the Conduit whereas neointimal thickness showed a peak at 6 months. Inflammatory process reached a maximum at 6 months and the degradation process at 12 months. Gel permeation chromatography analysis showed molecular weight loss beginning at 2 months with a peak at 12 months for the Conduit with slower absorption for the leaflets. The wall of the H Conduits showed more neointimal thickening, narrowing, and calcification compared with XPV, but the leaflets demonstrated minimal changes. Conclusions Both Conduits demonstrated an acceptable safety and functionality. Significant calcification was rarely observed in the XPV, whereas the H developed more neointimal thickness with calcification of the porcine aortic root portion of the wall.

  • Midterm performance of a novel restorative Pulmonary Valved Conduit: preclinical results.
    Eurointervention, 2017
    Co-Authors: Osama Ibrahim Ibrahim Soliman, Mohammad Abdelghani, Marieke Brugmans, Maarten Witsenburg, Yoshinobu Onuma, Yosuke Miyazaki, Patrick W. Serruys
    Abstract:

    Aims: The Xeltis bioabsorbable Pulmonary Valved Conduit (XPV), designed to guide functional restoration of patients' own tissue, is potentially more durable than current Pulmonary bioprosthetic valves/Valved Conduits. The aim of this study was to assess the haemodynamic performance of the novel XPV implanted in an ovine model. Methods and results: The XPV was surgically implanted in adult sheep under general anaesthesia and cardioPulmonary bypass (XPV group, n= 20). Sheep that received a Hancock bioprosthetic Pulmonary Valved Conduit served as a control group (HPV group, n = 3). Transthoracic echocardiograms from VARC-2 recommended time points at 3, 6, 9, 12, 18 and 24 months (XPV group) and at 3 and 6 months (HPV group) after the procedure were analysed in an independent core laboratory. The primary endpoint was favourable Valved Conduit performance, defined as peak systolic pressure gradient

  • midterm performance of a novel restorative Pulmonary Valved Conduit preclinical results
    Eurointervention, 2017
    Co-Authors: Osama Ibrahim Ibrahim Soliman, Mohammad Abdelghani, Marieke Brugmans, Maarten Witsenburg, Yoshinobu Onuma, Yosuke Miyazaki, Patrick W. Serruys
    Abstract:

    Aims: The Xeltis bioabsorbable Pulmonary Valved Conduit (XPV), designed to guide functional restoration of patients' own tissue, is potentially more durable than current Pulmonary bioprosthetic valves/Valved Conduits. The aim of this study was to assess the haemodynamic performance of the novel XPV implanted in an ovine model. Methods and results: The XPV was surgically implanted in adult sheep under general anaesthesia and cardioPulmonary bypass (XPV group, n= 20). Sheep that received a Hancock bioprosthetic Pulmonary Valved Conduit served as a control group (HPV group, n = 3). Transthoracic echocardiograms from VARC-2 recommended time points at 3, 6, 9, 12, 18 and 24 months (XPV group) and at 3 and 6 months (HPV group) after the procedure were analysed in an independent core laboratory. The primary endpoint was favourable Valved Conduit performance, defined as peak systolic pressure gradient <40 mmHg, no severe Pulmonary regurgitation (PR), and a maximum Conduit patency index of -20%. In the latter, negative values denote luminal narrowing and vice versa. The valvular peak systolic pressure gradient (mmHg) was 25.6 +/- 9.7 (3 months), 19.6 +/- 7.1 (6 months), 10.0 +/- 9.2 (24 months) in the XPV group and 18.4 +/- 6.6 (3 months), 17.7 +/- 4.6 (6 months) in the HPV group. The patency index (%) of the Conduit at the valvular level was + 30.3 +/- 13.6 (6 months) and + 64.1 +/- 1.4 (24 months) in the XPV group and + 2.0 +/- 15.9 (6 months) in the HPV group. PR was trace or mild at all visits, except in one animal with persistent moderate PR in the XPV group, up to 24 months. Conclusions: The XPV showed a favourable and durable haemodynamic performance (up to two years after implantation), without Conduit narrowing/obstruction or severe regurgitation

Mohammad Abdelghani - One of the best experts on this subject based on the ideXlab platform.

  • Midterm performance of a novel restorative Pulmonary Valved Conduit: preclinical results.
    Eurointervention, 2017
    Co-Authors: Osama Ibrahim Ibrahim Soliman, Mohammad Abdelghani, Marieke Brugmans, Maarten Witsenburg, Yoshinobu Onuma, Yosuke Miyazaki, Patrick W. Serruys
    Abstract:

    Aims: The Xeltis bioabsorbable Pulmonary Valved Conduit (XPV), designed to guide functional restoration of patients' own tissue, is potentially more durable than current Pulmonary bioprosthetic valves/Valved Conduits. The aim of this study was to assess the haemodynamic performance of the novel XPV implanted in an ovine model. Methods and results: The XPV was surgically implanted in adult sheep under general anaesthesia and cardioPulmonary bypass (XPV group, n= 20). Sheep that received a Hancock bioprosthetic Pulmonary Valved Conduit served as a control group (HPV group, n = 3). Transthoracic echocardiograms from VARC-2 recommended time points at 3, 6, 9, 12, 18 and 24 months (XPV group) and at 3 and 6 months (HPV group) after the procedure were analysed in an independent core laboratory. The primary endpoint was favourable Valved Conduit performance, defined as peak systolic pressure gradient

  • midterm performance of a novel restorative Pulmonary Valved Conduit preclinical results
    Eurointervention, 2017
    Co-Authors: Osama Ibrahim Ibrahim Soliman, Mohammad Abdelghani, Marieke Brugmans, Maarten Witsenburg, Yoshinobu Onuma, Yosuke Miyazaki, Patrick W. Serruys
    Abstract:

    Aims: The Xeltis bioabsorbable Pulmonary Valved Conduit (XPV), designed to guide functional restoration of patients' own tissue, is potentially more durable than current Pulmonary bioprosthetic valves/Valved Conduits. The aim of this study was to assess the haemodynamic performance of the novel XPV implanted in an ovine model. Methods and results: The XPV was surgically implanted in adult sheep under general anaesthesia and cardioPulmonary bypass (XPV group, n= 20). Sheep that received a Hancock bioprosthetic Pulmonary Valved Conduit served as a control group (HPV group, n = 3). Transthoracic echocardiograms from VARC-2 recommended time points at 3, 6, 9, 12, 18 and 24 months (XPV group) and at 3 and 6 months (HPV group) after the procedure were analysed in an independent core laboratory. The primary endpoint was favourable Valved Conduit performance, defined as peak systolic pressure gradient <40 mmHg, no severe Pulmonary regurgitation (PR), and a maximum Conduit patency index of -20%. In the latter, negative values denote luminal narrowing and vice versa. The valvular peak systolic pressure gradient (mmHg) was 25.6 +/- 9.7 (3 months), 19.6 +/- 7.1 (6 months), 10.0 +/- 9.2 (24 months) in the XPV group and 18.4 +/- 6.6 (3 months), 17.7 +/- 4.6 (6 months) in the HPV group. The patency index (%) of the Conduit at the valvular level was + 30.3 +/- 13.6 (6 months) and + 64.1 +/- 1.4 (24 months) in the XPV group and + 2.0 +/- 15.9 (6 months) in the HPV group. PR was trace or mild at all visits, except in one animal with persistent moderate PR in the XPV group, up to 24 months. Conclusions: The XPV showed a favourable and durable haemodynamic performance (up to two years after implantation), without Conduit narrowing/obstruction or severe regurgitation

Maarten Witsenburg - One of the best experts on this subject based on the ideXlab platform.

  • Midterm performance of a novel restorative Pulmonary Valved Conduit: preclinical results.
    Eurointervention, 2017
    Co-Authors: Osama Ibrahim Ibrahim Soliman, Mohammad Abdelghani, Marieke Brugmans, Maarten Witsenburg, Yoshinobu Onuma, Yosuke Miyazaki, Patrick W. Serruys
    Abstract:

    Aims: The Xeltis bioabsorbable Pulmonary Valved Conduit (XPV), designed to guide functional restoration of patients' own tissue, is potentially more durable than current Pulmonary bioprosthetic valves/Valved Conduits. The aim of this study was to assess the haemodynamic performance of the novel XPV implanted in an ovine model. Methods and results: The XPV was surgically implanted in adult sheep under general anaesthesia and cardioPulmonary bypass (XPV group, n= 20). Sheep that received a Hancock bioprosthetic Pulmonary Valved Conduit served as a control group (HPV group, n = 3). Transthoracic echocardiograms from VARC-2 recommended time points at 3, 6, 9, 12, 18 and 24 months (XPV group) and at 3 and 6 months (HPV group) after the procedure were analysed in an independent core laboratory. The primary endpoint was favourable Valved Conduit performance, defined as peak systolic pressure gradient

  • midterm performance of a novel restorative Pulmonary Valved Conduit preclinical results
    Eurointervention, 2017
    Co-Authors: Osama Ibrahim Ibrahim Soliman, Mohammad Abdelghani, Marieke Brugmans, Maarten Witsenburg, Yoshinobu Onuma, Yosuke Miyazaki, Patrick W. Serruys
    Abstract:

    Aims: The Xeltis bioabsorbable Pulmonary Valved Conduit (XPV), designed to guide functional restoration of patients' own tissue, is potentially more durable than current Pulmonary bioprosthetic valves/Valved Conduits. The aim of this study was to assess the haemodynamic performance of the novel XPV implanted in an ovine model. Methods and results: The XPV was surgically implanted in adult sheep under general anaesthesia and cardioPulmonary bypass (XPV group, n= 20). Sheep that received a Hancock bioprosthetic Pulmonary Valved Conduit served as a control group (HPV group, n = 3). Transthoracic echocardiograms from VARC-2 recommended time points at 3, 6, 9, 12, 18 and 24 months (XPV group) and at 3 and 6 months (HPV group) after the procedure were analysed in an independent core laboratory. The primary endpoint was favourable Valved Conduit performance, defined as peak systolic pressure gradient <40 mmHg, no severe Pulmonary regurgitation (PR), and a maximum Conduit patency index of -20%. In the latter, negative values denote luminal narrowing and vice versa. The valvular peak systolic pressure gradient (mmHg) was 25.6 +/- 9.7 (3 months), 19.6 +/- 7.1 (6 months), 10.0 +/- 9.2 (24 months) in the XPV group and 18.4 +/- 6.6 (3 months), 17.7 +/- 4.6 (6 months) in the HPV group. The patency index (%) of the Conduit at the valvular level was + 30.3 +/- 13.6 (6 months) and + 64.1 +/- 1.4 (24 months) in the XPV group and + 2.0 +/- 15.9 (6 months) in the HPV group. PR was trace or mild at all visits, except in one animal with persistent moderate PR in the XPV group, up to 24 months. Conclusions: The XPV showed a favourable and durable haemodynamic performance (up to two years after implantation), without Conduit narrowing/obstruction or severe regurgitation