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

PY - 2020

Y1 - 2020

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. ClinicalTrials.gov Identifier: NCT03417011 Visual summary. Paravalvular leak at discharge and (right) the Evolut PRO valve (Medtronic) with external pericardial wrap. Reproduced with permission from Medtronic, Inc.

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. ClinicalTrials.gov Identifier: NCT03417011 Visual summary. Paravalvular leak at discharge and (right) the Evolut PRO valve (Medtronic) with external pericardial wrap. Reproduced with permission from Medtronic, Inc.

KW - Aged

KW - Aged, 80 and over

KW - Aortic Valve/diagnostic imaging

KW - Aortic Valve Stenosis/diagnostic imaging

KW - Female

KW - Heart Valve Prosthesis

KW - Humans

KW - Male

KW - Postoperative Complications

KW - Prospective Studies

KW - Prosthesis Design

KW - Transcatheter Aortic Valve Replacement/adverse effects

KW - Treatment Outcome

U2 - 10.4244/EIJ-D-20-00279

DO - 10.4244/EIJ-D-20-00279

M3 - Journal article

C2 - 32748789

VL - 16

SP - 850

EP - 857

JO - EuroIntervention

JF - EuroIntervention

SN - 1774-024X

IS - 10

ER -