TY - JOUR
T1 - Thirty-day clinical outcomes of the Evolut PRO self-expanding transcatheter aortic valve
T2 - The international FORWARD PRO study
AU - Manoharan, Ganesh
AU - Grube, Eberhard
AU - Van Mieghem, Nicolas M.
AU - Brecker, Stephen
AU - Fiorina, Claudia
AU - Kornowski, Ran
AU - Danenberg, Haim
AU - Ruge, Hendrik
AU - Thiele, Holger
AU - Lancellotti, Patrizio
AU - Søndergaard, Lars
AU - Tamburino, Corrado
AU - Oh, Jae K.
AU - Fan, Yunhua
AU - Windecker, Stephan
N1 - Funding Information:
G. Manoharan has served as a proctor for Medtronic and Abbott. E. Grube serves on an advisory board for Medtronic, Boston Scientific and HighLife, and has an equity interest in CardioValve, Valve Medical, Shockwave, Millipede, Pi-Cardia, Pipeline, Ancora and Laminar. N. Van Mieghem has received grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences and Medtronic, and advisory fees from Abbott, Boston Scientific, PulseCath BV and Medtronic. S. Brecker has received consultant fees from Medtronic, Boston Scientific and Meril Life Sciences. H. Danenberg is a clinical proctor for Medtronic. C. Tamburino reports personal fees from Medtronic during the conduct of the study and personal fees from Medtronic outside the submitted work. J.K. Oh has received research support for the echocardiographic core laboratory from Medtronic. Y. Fan is an employee and shareholder of Medtronic, plc. S. Windecker has received grant support from Abbott, Amgen, Bayer, Biotronik, BMS, Boston Scientific, Cardinal Health, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Johnson&Johnson, Medtronic, Polares Medical, Querbeet, Sanofi and Terumo outside the submitted work. The other authors have no conflicts of interest to declare.
Publisher Copyright:
© Europa Digital & Publishing 2020.
PY - 2020/11
Y1 - 2020/11
N2 - Aims: The Evolut PRO is a new transcatheter heart valve with an outer pericardial wrap intended to reduce paravalvular leak and facilitate tissue ingrowth. We aimed to evaluate the clinical performance and safety of the Evolut PRO valve in standard practice. Methods and results: FORWARD PRO is a prospective, multinational, multicentre observational study. Transcatheter aortic valve implantation with the Evolut PRO valve (23, 26, or 29 mm) was attempted in 629 non-consecutive patients from 39 centres from February 2018 to January 2019. The primary endpoint was the rate of all-cause mortality at 30 days compared to a pre-specified performance goal. An independent clinical events committee adjudicated safety endpoints based on VARC-2 definitions. All echocardiograms were centrally assessed by an independent core laboratory (Mayo Clinic, Rochester, MN, USA). Baseline characteristics included mean age 81.7±6.1 years, 61.8% female, STS score 4.7±3.3%, and 33.6% were frail. All-cause mortality at 30 days was 3.2%, which was lower than the pre-specified performance goal of 5.5% (p=0.004). Greater than mild AR was present in 1.8% of patients at discharge. Conclusions: The FORWARD PRO study confirmed the safety and efficacy of the Evolut PRO transcatheter aortic valve system with an external pericardial wrap.
AB - Aims: The Evolut PRO is a new transcatheter heart valve with an outer pericardial wrap intended to reduce paravalvular leak and facilitate tissue ingrowth. We aimed to evaluate the clinical performance and safety of the Evolut PRO valve in standard practice. Methods and results: FORWARD PRO is a prospective, multinational, multicentre observational study. Transcatheter aortic valve implantation with the Evolut PRO valve (23, 26, or 29 mm) was attempted in 629 non-consecutive patients from 39 centres from February 2018 to January 2019. The primary endpoint was the rate of all-cause mortality at 30 days compared to a pre-specified performance goal. An independent clinical events committee adjudicated safety endpoints based on VARC-2 definitions. All echocardiograms were centrally assessed by an independent core laboratory (Mayo Clinic, Rochester, MN, USA). Baseline characteristics included mean age 81.7±6.1 years, 61.8% female, STS score 4.7±3.3%, and 33.6% were frail. All-cause mortality at 30 days was 3.2%, which was lower than the pre-specified performance goal of 5.5% (p=0.004). Greater than mild AR was present in 1.8% of patients at discharge. Conclusions: The FORWARD PRO study confirmed the safety and efficacy of the Evolut PRO transcatheter aortic valve system with an external pericardial wrap.
KW - Aortic stenosis
KW - TAVI
KW - Transoesophageal echocardiogram
KW - Transthoracic echocardiogram
UR - http://www.scopus.com/inward/record.url?scp=85096814761&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85096814761&partnerID=8YFLogxK
U2 - 10.4244/EIJ-D-20-00279
DO - 10.4244/EIJ-D-20-00279
M3 - Article
C2 - 32748789
AN - SCOPUS:85096814761
SN - 1774-024X
VL - 16
SP - 850
EP - 857
JO - EuroIntervention
JF - EuroIntervention
IS - 10
ER -