Konstantinos Kalogeras1, Neil Ruparelia2, Tito Kabir3, Richard Jabbour2, Toru Naganuma4, Manolis Vavuranakis5, Sunao Nakamura4, Brian Wang2, Sayan Sen2, Nearchos Hadjiloizou6, Iqbal S Malik2, Ghada Mikhail2, Miles Dalby7, Vasileios Panoulas7. 1. Department of Cardiology, Harefield Hospital, Royal Brompton and Harefield Foundation Trust, London, UK; 1st Department of Cardiology, Hippokration Hospital, Medical School, National & Kapodistrian University of Athens, Greece. 2. Cardiovascular Sciences, National Heart and Lung Institute, Imperial College London, London, UK; Department of Cardiology, Hammersmith Hospital, Imperial College Healthcare NHS Trust. 3. Department of Cardiology, Harefield Hospital, Royal Brompton and Harefield Foundation Trust, London, UK. 4. Department of Cardiology, New Tokyo Hospital, Matsudo, Japan. 5. 1st Department of Cardiology, Hippokration Hospital, Medical School, National & Kapodistrian University of Athens, Greece; 3(rd) Department of Cardiology, Sotiria Hospital, National & Kapodistrian University of Athens, Greece. 6. Cardiovascular Sciences, National Heart and Lung Institute, Imperial College London, London, UK. 7. Department of Cardiology, Harefield Hospital, Royal Brompton and Harefield Foundation Trust, London, UK; Cardiovascular Sciences, National Heart and Lung Institute, Imperial College London, London, UK.
Abstract
BACKGROUND: The Evolut PRO self-expanding transcatheter aortic valve has been designed to feature an outer pericardial wrap that aims to reduce paravalvular regurgitation (PVR) rates. Medium-term clinical outcomes, compared to its predecessor Evolut R, in a real-world setting, have not been investigated. The aim of the present study was to compare the two valves with regards to peri-procedural complications, early outcomes and mid-term survival. METHODS: Consecutive patients, undergoing TAVI with either the Evolut PRO or Evolut R device, from the multicenter ATLAS registry were retrospectively studied. Outcomes studied included periprocedural complications, PVR at discharge, need for new pacemaker implantation and Kaplan-Meier estimated 1-year all-cause mortality. RESULTS: Analysis included 673 patients (498 treated with Evolut R and 175 treated with Evolut PRO). At least moderate PVR was numerically lower amongst patients treated with Evolut PRO (7.4% vs 3.8% for Evolut R and Evolut PRO respectively, p = .108). Rates of new permanent pacemaker (PPM) implantation (21.1% vs. 11.9%, p = .023), and bail-out valve-in-valve (2.4% vs. 0%, p = .049) were significantly lower amongst the Evolut PRO group. No differences were demonstrated regarding bleeding, stroke or acute kidney injury. One-year Kaplan-Meier estimated survival was similar between groups (93% for Evolut R vs. 91.2% for Evolut PRO, plog-rank = 0.806). CONCLUSIONS: The Evolut PRO self-expanding valve demonstrates similar mid-term survival rates and numerically, yet not significant, lower incidence of PVR compared to its predecessor. Interestingly this new generation valve is associated with a significantly reduced rate for new PPM implantation. Future studies are required to confirm this finding.
BACKGROUND: The Evolut PRO self-expanding transcatheter aortic valve has been designed to feature an outer pericardial wrap that aims to reduce paravalvular regurgitation (PVR) rates. Medium-term clinical outcomes, compared to its predecessor Evolut R, in a real-world setting, have not been investigated. The aim of the present study was to compare the two valves with regards to peri-procedural complications, early outcomes and mid-term survival. METHODS: Consecutive patients, undergoing TAVI with either the Evolut PRO or Evolut R device, from the multicenter ATLAS registry were retrospectively studied. Outcomes studied included periprocedural complications, PVR at discharge, need for new pacemaker implantation and Kaplan-Meier estimated 1-year all-cause mortality. RESULTS: Analysis included 673 patients (498 treated with Evolut R and 175 treated with Evolut PRO). At least moderate PVR was numerically lower amongst patients treated with Evolut PRO (7.4% vs 3.8% for Evolut R and Evolut PRO respectively, p = .108). Rates of new permanent pacemaker (PPM) implantation (21.1% vs. 11.9%, p = .023), and bail-out valve-in-valve (2.4% vs. 0%, p = .049) were significantly lower amongst the Evolut PRO group. No differences were demonstrated regarding bleeding, stroke or acute kidney injury. One-year Kaplan-Meier estimated survival was similar between groups (93% for Evolut R vs. 91.2% for Evolut PRO, plog-rank = 0.806). CONCLUSIONS: The Evolut PRO self-expanding valve demonstrates similar mid-term survival rates and numerically, yet not significant, lower incidence of PVR compared to its predecessor. Interestingly this new generation valve is associated with a significantly reduced rate for new PPM implantation. Future studies are required to confirm this finding.
Authors: Teresa Alvarado; Fernando Rivero; Guillermo Diego; Marcos García-Guimaraes; Jorge Salamanca; Pablo Díez-Villanueva; Javier Cuesta; Paula Antuña; Jesús Jiménez-Borreguero; Fernando Alfonso Journal: J Thorac Dis Date: 2021-07 Impact factor: 2.895