30-day clinical outcomes of a self-expanding transcatheter aortic valve: The International PORTICO NG Study

Authors

Michael J. Reardon, Department of Cardiovascular Surgery, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas, USA. Electronic address: mreardon@houstonmethodist.org.
Bassem Chehab, Department of Cardiology, Ascension Via Christi Hospital, University of Kansas, Wichita, Kansas, USA.Follow
Dave Smith, Morriston Hospital, Swansea Bay University Health Board, Swansea, United Kingdom.
Antony S. Walton, Department of Interventional Cardiology, Alfred Hospital, Melbourne, Victoria, Australia; Monash University, Melbourne, Victoria, Australia.
Stephen G. Worthley, Department of Cardiology, Macquarie University Hospital, New South Wales, Australia.
Ganesh Manoharan, Regional Cardiology Centre, Royal Victoria Hospital, Belfast, United Kingdom.
Ibrahim Sultan, Division of Cardiac Surgery, Department of Cardiothoracic Surgery, Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
Gerald Yong, Department of Cardiology, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.
Katherine Harrington, Department of Cardiothoracic Surgery, The Heart Hospital Baylor Plano, Plano, Texas, USA.
Paul Mahoney, Department of Cardiovascular Services, The Sentara Heart Center, Norfolk, Virginia, USA.
Neal Kleiman, Department of Cardiology, Section of Interventional Cardiology, Houston DeBakey Heart and Vascular Center, Houston, Texas, USA.
Raj R. Makkar, Cedars-Sinai Medical Center, Los Angeles, California, USA.
Gregory Fontana, Cardiovascular Institute, Hospital Corporation of America, Los Robles Hospital and Medical Center, Thousand Oaks, California, USA.
Augustin DeLago, Division of Cardiology, Albany Medical Center, Albany, New York, USA.Follow
Ravi K. Ramana, Advocate Aurora HealthFollow
Nicholas Bates, Structural Heart Clinical Affairs, Abbott Medical, St Paul, Minnesota, USA.
Lars Søndergaard, Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.

Recommended Citation

Reardon MJ, Chehab B, Smith D, et al. 30-Day Clinical Outcomes of a Self-Expanding Transcatheter Aortic Valve: The International PORTICO NG Study. JACC Cardiovasc Interv. 2023;16(6):681-689. doi:10.1016/j.jcin.2023.02.002

Affiliations

Advocate Christ Medical Center

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 ).

Document Type

Article

PubMed ID

36990558