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Multicenter Study
. 2023 Mar 27;16(6):681-689.
doi: 10.1016/j.jcin.2023.02.002. Epub 2023 Feb 27.

30-Day Clinical Outcomes of a Self-Expanding Transcatheter Aortic Valve: The International PORTICO NG Study

Michael J Reardon  1 , Bassem Chehab  2 , Dave Smith  3 , Antony S Walton  4 , Stephen G Worthley  5 , Ganesh Manoharan  6 , Ibrahim Sultan  7 , Gerald Yong  8 , Katherine Harrington  9 , Paul Mahoney  10 , Neal Kleiman  11 , Raj R Makkar  12 , Gregory Fontana  13 , Augustin DeLago  14 , Ravi K Ramana  15 , Nicholas Bates  16 , Lars Søndergaard  17
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Free article
Multicenter Study

30-Day Clinical Outcomes of a Self-Expanding Transcatheter Aortic Valve: The International PORTICO NG Study

Michael J Reardon et al. JACC Cardiovasc Interv. .
Free article

Abstract

Background: The self-expanding, intra-annular Navitor (Abbott Structural Heart) valve includes an outer cuff to reduce paravalvular leak (PVL) and large stent cells for future coronary access.

Objectives: The purpose of the PORTICO NG (Evaluation of the Portico NG [Next Generation] Transcatheter Aortic Valve in High and Extreme Risk Patients With Symptomatic Severe Aortic Stenosis) study is to evaluate the safety and effectiveness of the Navitor valve in patients with symptomatic, severe aortic stenosis who are at high or extreme surgical risk.

Methods: PORTICO NG is a prospective, multicenter, global study with follow-up at 30 days, 1 year, and annually through 5 years. The primary endpoints are all-cause mortality and moderate or greater PVL at 30 days. Valve Academic Research Consortium-2 events and valve performance are assessed by an independent clinical events committee and echocardiographic core laboratory.

Results: A total of 260 subjects were treated at 26 clinical sites across Europe, Australia, and the United States between September 2019 and August 2022. The mean age was 83.4 ± 5.4 years, 57.3% were female, and the average Society of Thoracic Surgeons score was 3.9% ± 2.1%. At 30 days, the rate of all-cause mortality was 1.9%, and no subjects had moderate or greater PVL. The rate of disabling stroke was 1.9%, life-threatening bleeding was 3.8%, stage 3 acute kidney injury was 0.8%, major vascular complications were 4.2%, and new permanent pacemaker implantation was 19.0%. Hemodynamic performance included a mean gradient of 7.4 ± 3.5 mm Hg and an effective orifice area of 2.00 ± 0.47 cm2.

Conclusions: The Navitor valve is safe and effective for the treatment of subjects with severe aortic stenosis who are at high or greater risk for surgery, which is supported by low rates of adverse events and PVL. (Evaluation of the Portico NG [Next Generation] Transcatheter Aortic Valve in High and Extreme Risk Patients With Symptomatic Severe Aortic Stenosis [PORTICO NG]; NCT04011722).

Keywords: Navitor; aortic stenosis; paravalvular leak; transcatheter aortic valve replacement.

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Conflict of interest statement

Funding Support and Author Disclosures Dr Reardon has received consultant fees and/or institutional research grants from Abbott, Boston Scientific, Medtronic, and Gore Medical. Dr Chehab has received speaker, consultancy, and proctor fees for Abbott, Edwards Lifesciences, Medtronic, and CSI. Dr Smith has received speaker and proctor fees for Abbott, Edwards Lifesciences, and Biosensors. Dr Walton is a proctor, on medical advisory boards, and has received grant support from Abbott, Medtronic, and Edwards Lifesciences. Dr Worthley has received speaker fees and proctorship from Abbott and HighLife Medical; and has received consultancy fees from Edwards Lifesciences. Dr Manoharan is a proctor for Abbott and Medtronic. Dr Sultan is a consultant for Abbott, Artivion, Medtronic, and Terumo Aortic. Dr Yong is a proctor for Abbott. Dr Harrington reports consultancy for Abbott and Boston Scientific; has received speaker fees for Boston Scientific, Artivion, and Edwards Lifesciences; and has received proctor fees for Edwards Lifesciences. Dr Mahoney has received speaker fees; and is a consultant and proctor for Abbott, Medtronic, Edwards Lifesciences, and Boston Scientific. Dr Kleiman participated as an investigator for Abbott, Boston Scientific, and Edwards Lifesciences. Dr Makkar is a proctor for Edwards Lifescience; a consultant for Cordis and Medtronic; and has received research grants from Abbott, Edwards Lifesciences, and Boston Scientific. Dr Fontana is a consultant, proctor, and speaker for Abbott and Medtronic. Dr DeLago has received speaker fees and is a consultant for Edwards Lifesciences and Boston Scientific; and is a proctor for Abbott, Edwards Lifesciences, and Boston Scientific. Dr Ramana is a consultant for Abbott, Medtronic, Boston Scientific, and Edwards Lifesciences. Dr Bates is an employee of Abbott. Dr Søndergaard has received consultant fees and/or institutional research grants from Abbott, Boston Scientific, Medtronic, and Sahajanand Medical Technologies.

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