Three‐Year Outcomes With a Supra‐Annular, Self‐Expanding Bioprosthesis and a Pericardial Wrap—The FORWARD PRO Study
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Wiley
2024
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| author | Nicolas M. Van Mieghem Stephan Windecker Ganesh Manoharan Patrizio Lancellotti Corrado Tamburino Ran Kornowski Holger Thiele Haim Danenberg Claudia Fiorina Werner Scholtz Stephen Brecker Hendrik Ruge Anders Opdahl Giovanni Amoroso Francesco Bedogni Anna Sonia Petronio Georg Nickenig Axel Harnath Joerg Kempfert Jae K. Oh Ruth E. Eisenberg Eberhard Grube |
| author_facet | Nicolas M. Van Mieghem Stephan Windecker Ganesh Manoharan Patrizio Lancellotti Corrado Tamburino Ran Kornowski Holger Thiele Haim Danenberg Claudia Fiorina Werner Scholtz Stephen Brecker Hendrik Ruge Anders Opdahl Giovanni Amoroso Francesco Bedogni Anna Sonia Petronio Georg Nickenig Axel Harnath Joerg Kempfert Jae K. Oh Ruth E. Eisenberg Eberhard Grube Nicolas M. Van Mieghem Stephan Windecker Ganesh Manoharan Patrizio Lancellotti Corrado Tamburino Ran Kornowski Holger Thiele Haim Danenberg Claudia Fiorina Werner Scholtz Stephen Brecker Hendrik Ruge Anders Opdahl Giovanni Amoroso Francesco Bedogni Anna Sonia Petronio Georg Nickenig Axel Harnath Joerg Kempfert Jae K. Oh Ruth E. Eisenberg Eberhard Grube |
| collection | Wiley Open Access |
| contents | Three‐Year Outcomes With a Supra‐Annular, Self‐Expanding Bioprosthesis and a Pericardial Wrap—The FORWARD PRO Study Nicolas M. Van Mieghem Stephan Windecker Ganesh Manoharan Patrizio Lancellotti Corrado Tamburino Ran Kornowski Holger Thiele Haim Danenberg Claudia Fiorina Werner Scholtz Stephen Brecker Hendrik Ruge Anders Opdahl Giovanni Amoroso Francesco Bedogni Anna Sonia Petronio Georg Nickenig Axel Harnath Joerg Kempfert Jae K. Oh Ruth E. Eisenberg Eberhard Grube Catheterization and Cardiovascular Interventions ABSTRACTBackgroundThe self‐expanding, supra‐annular Evolut valve is an established platform for Transcatheter Aortic Valve Implantation (TAVI). Evolut PRO introduced an outer sealing wrap to mitigate paravalvular leakage. We evaluated the 3‐year clinical outcomes and valve performance of the Evolut PRO in standard clinical practice for severe aortic stenosis (AS) patients at intermediate or higher risk for surgery.MethodsThe FORWARD PRO prospective, single‐arm, multicentre, post‐market clinical study enrolled 638 patients with native aortic valve stenosis or failed surgical bioprosthetic aortic valve undergoing TAVI, at intermediate or high risk, with the Evolut PRO valve. Clinical and serial echocardiographic outcomes were followed‐up for 3 years.ResultsTAVI using Evolut PRO was attempted in 629 AS patients (implanted in 97%) (mean age 81.7 years; STS PROM score, 4.7%). At 3 years all‐cause mortality was 25.0%, disabling stroke 6.5% (all‐cause mortality or disabling stroke, 28.5%) and rate of new permanent pacemaker implantation 24.7%. Excellent valve haemodynamics were maintained (mean gradient 8.8 ± 4.7 mm Hg; mean effective orifice area 2.0 ± 0.5 cm2) at 3 years. In a paired analysis of patients with ≥ mild paravalvular leakage (PVL) at discharge, more than two‐thirds demonstrated improved PVL at 3 years. Patients with ≥ mild PVL at discharge had higher median total calcium volume than those with no/trace PVL (p < 0.001).ConclusionsIn clinical practice TAVI with the Evolut PRO valve is associated with favorable clinical outcomes and excellent haemodynamic performance out to 3 years. The observation of improvements in PVL over time warrants further research. 10.1002/ccd.31335 http://creativecommons.org/licenses/by-nc-nd/4.0/ |
| doi_str_mv | 10.1002/ccd.31335 |
| format | Artículo Open Access |
| id | wiley_oa_10_1002_ccd_31335 |
| institution | Wiley Open Access |
| license_str_mv | http://creativecommons.org/licenses/by-nc-nd/4.0/ |
| publishDate | 2024 |
| publisher | Wiley |
| record_format | wiley_oa |
| spellingShingle | Three‐Year Outcomes With a Supra‐Annular, Self‐Expanding Bioprosthesis and a Pericardial Wrap—The FORWARD PRO Study Nicolas M. Van Mieghem Stephan Windecker Ganesh Manoharan Patrizio Lancellotti Corrado Tamburino Ran Kornowski Holger Thiele Haim Danenberg Claudia Fiorina Werner Scholtz Stephen Brecker Hendrik Ruge Anders Opdahl Giovanni Amoroso Francesco Bedogni Anna Sonia Petronio Georg Nickenig Axel Harnath Joerg Kempfert Jae K. Oh Ruth E. Eisenberg Eberhard Grube Catheterization and Cardiovascular Interventions Three‐Year Outcomes With a Supra‐Annular, Self‐Expanding Bioprosthesis and a Pericardial Wrap—The FORWARD PRO Study Nicolas M. Van Mieghem Stephan Windecker Ganesh Manoharan Patrizio Lancellotti Corrado Tamburino Ran Kornowski Holger Thiele Haim Danenberg Claudia Fiorina Werner Scholtz Stephen Brecker Hendrik Ruge Anders Opdahl Giovanni Amoroso Francesco Bedogni Anna Sonia Petronio Georg Nickenig Axel Harnath Joerg Kempfert Jae K. Oh Ruth E. Eisenberg Eberhard Grube Catheterization and Cardiovascular Interventions ABSTRACTBackgroundThe self‐expanding, supra‐annular Evolut valve is an established platform for Transcatheter Aortic Valve Implantation (TAVI). Evolut PRO introduced an outer sealing wrap to mitigate paravalvular leakage. We evaluated the 3‐year clinical outcomes and valve performance of the Evolut PRO in standard clinical practice for severe aortic stenosis (AS) patients at intermediate or higher risk for surgery.MethodsThe FORWARD PRO prospective, single‐arm, multicentre, post‐market clinical study enrolled 638 patients with native aortic valve stenosis or failed surgical bioprosthetic aortic valve undergoing TAVI, at intermediate or high risk, with the Evolut PRO valve. Clinical and serial echocardiographic outcomes were followed‐up for 3 years.ResultsTAVI using Evolut PRO was attempted in 629 AS patients (implanted in 97%) (mean age 81.7 years; STS PROM score, 4.7%). At 3 years all‐cause mortality was 25.0%, disabling stroke 6.5% (all‐cause mortality or disabling stroke, 28.5%) and rate of new permanent pacemaker implantation 24.7%. Excellent valve haemodynamics were maintained (mean gradient 8.8 ± 4.7 mm Hg; mean effective orifice area 2.0 ± 0.5 cm2) at 3 years. In a paired analysis of patients with ≥ mild paravalvular leakage (PVL) at discharge, more than two‐thirds demonstrated improved PVL at 3 years. Patients with ≥ mild PVL at discharge had higher median total calcium volume than those with no/trace PVL (p < 0.001).ConclusionsIn clinical practice TAVI with the Evolut PRO valve is associated with favorable clinical outcomes and excellent haemodynamic performance out to 3 years. The observation of improvements in PVL over time warrants further research. 10.1002/ccd.31335 http://creativecommons.org/licenses/by-nc-nd/4.0/ |
| title | Three‐Year Outcomes With a Supra‐Annular, Self‐Expanding Bioprosthesis and a Pericardial Wrap—The FORWARD PRO Study |
| topic | Catheterization and Cardiovascular Interventions |
| url | https://onlinelibrary.wiley.com/doi/10.1002/ccd.31335 |