Author + information
- Gregory P. Fontana, MD FACC1,∗ (, )
- Francesco Bedogni, MD2,
- Mark Groh, MD3,
- David Smith, MD4,
- Bassem M. Chehab, MD FACC5,
- H. Edward Garrett Jr., MD6,
- Gerald Yong, MD7,
- Stephen Worthley, MD FACC8,9,
- Ganesh Manoharan, MD10,
- Antony Walton, MD11,
- James Hermiller, MD FACC12,
- Gaurav Dhar, MD FACC13,
- Ron Waksman, MD FACC14,
- Ravi K. Ramana, DO FACC15,16,
- Paul Mahoney, MD FACC17,
- Federico M. Asch, MD FACC18,
- Tarun Chakravarty, MD19,
- Hasan Jilaihawi, MD20 and
- Raj R. Makkar, MD FACC19
- 1Cardiovascular Institute, Los Robles Regional Medical Center, Thousand Oaks, CA, USA
- 2IRCCS Policlinico, San Donato, Milan, Italy
- 3Mission Health and Hospitals, Asheville, NC, USA
- 4Morriston Hospital - Swansea Bay University Health Board, Swansea, UK
- 5Ascension Via Christi Hospital, University of Kansas, Wichita, KS, USA
- 6Baptist Memorial Hospital, TN, USA
- 7Fiona Stanley Hospital, Murdoch, Western Australia, Australia
- 8Royal Adelaide Hospital, Adelaide, South Australia, Australia
- 9Genesis Care, Sydney, New South Wales, Australia
- 10Royal Victoria Hospital, Belfast, UK
- 11The Alfred Hospital, Victoria, AUS
- 12St Vincent Heart Center, Indianapolis, IN, USA
- 13Sparrow Clinical Research Institute, MI, USA
- 14Medstar Washington Hospital Center, Washington, DC, USA
- 15Advocate Christ Medical Center, Oak Lawn, IL, USA
- 16Heart Care Centers of Illinois, Palos Park, IL, USA
- 17Sentara Norfolk General Hospital, VA, USA
- 18MedStar Health Research Institute, Washington, DC, USA
- 19Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA
- 20NYU Langone Health, New York, NY, USA
- ↵∗Address for Correspondence: Gregory P Fontana, MD Los Robles Regional Medical Center Thousand Oaks, CA, USA Telephone: 805-852-9100 Fax number: 844-442-4951
Objectives To characterize the safety profile of an intra-annular self-expanding valve with a next-generation low-profile Delivery System (DS).
Background Key design modifications to the FlexNav™ DS include the addition of a hydrophilic-coated, integrated sheath and stability layer to facilitate gradual, controlled deployment in a vessel diameter ≥ 5 mm.
Methods Patients were pooled from two concurrent prospective, multicenter, single-arm studies (FlexNav DS Study arm of PORTICO IDE trial, N=134; FlexNav DS EU CE Mark Study, N=46) for the analysis. Primary endpoint was VARC-2 defined major vascular complications at 30 days. Clinical outcomes and valve performance were assessed through 30-days by an independent Clinical Events Committee and Echocardiographic core laboratory respectively.
Results 140 High and 40 Extreme risk subjects enrolled between October 15, 2018 and December 10, 2019 from 28 sites in the United States, Australia and Europe that underwent an attempted transfemoral Portico™ valve implant were included. Mean age of subjects was 85.1 ± 5.6 years, 60% were female, mean STS score was 5.3% and 96.1% presented with ≥1 frailty factor. Technical device success was 96.7%. At 30 days, major vascular complications rate was 5.0%; with 4.4% adjudicated as access-site related (3.3% TAVR DS access-site related). Death (0.6%) and disabling stroke (1.1%) were rare. New permanent pacemaker rate was 15.4%. Echocardiography revealed 7.0 ± 3.2 mmHg mean gradient, 1.78 ± 0.41 cm2 valve area and 4.1% moderate paravalvular leak at 30 days.
Conclusions Portico valve implantation with the FlexNav DS was associated with an excellent safety profile at 30 days.
GPF is a consultant and has received proctoring fees from Abbott Inc., Medtronic and LivaNova; Structural Heart Safety Advisory Board Member for Abbott Inc.; Principal Investigator for Abbott Inc. and Medtronic.
FB has served as a consultant for Boston Scientific, Medtronic, and Abbott.
MG is a Structural Heart Safety Advisory Board Member for Abbott Inc
DS has received speaker fees and proctor fees from Abbott.
BMC has received grant/research support from Abbott; Received speaking/proctoring fees from Abbott, Edwards Lifesciences, Medtronic and Boston Scientific.
HEG has no relationships relevant to the contents of this paper to disclose.
GY is a physician proctor for Abbott Vascular, Medtronic and Edwards Lifesciences.
SW has received research grants from Abbott and Biotronik GM
GM has served as a proctor for Boston Scientific, Medtronic, and Abbott.
AW is a Proctor for Medtronic and Abbott; Medical Advisory Board for Medtronic; Received grant support from Medtronic, Abbott and Edwards Lifesciences.
JH is a physician proctor for Abbott
GD is a proctor for Abbott Vascular, Edwards Lifescience and Medtronic; Received esearch grant from Boston Scientific; Interventional cardiology Medical Advisory Board of Boston Scientific; Speaker bureau for Boston Scientific.
RW on the Advisory Board for: Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant for: Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Received Grant Support from: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance.
RKR received speaker, consulting and proctoring fees from Edwards Lifesciences. Consulting fees from Abbott and Medtronic. Research support from Boston Scientific.
PM is a consultant/proctor for Edwards Lifesciences; consultant for Abbott Inc.
FA has no personal conflicts of interest to report; and the following institutional (MedStar Health) disclosures: director of an Academic Echocardiographic Core laboratory with institutional research contracts with Abbott, Edwards, Boston Scientific, Medtronic, Livanova, Biotronik and Vascular Innovations.
TC is a consultant for Edwards LifeSciences, Medtronic, Abbott and Boston Scientific
HJ has been a consultant to Boston Scientific and Medronic Inc; and has received grant/research support from Medtronic, Edwards Lifesciences, Abbott Vascular and HLT.
RRM has received research grants, speaker and proctoring fees from Edwards Lifesciences, Abbott Inc., Medtronic and Boston Scientific.
- Received June 10, 2020.
- Revision received June 18, 2020.
- Accepted June 19, 2020.
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