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Objectives: The aim of this study was 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 vessels with diameter ≥5 mm., Methods: Patients were pooled from 2 concurrent prospective, multicenter, single-arm studies (FlexNav DS arm of PORTICO IDE [Portico Re-Sheathable Transcatheter Aortic Valve System U.S. IDE Trial] [n = 134] and the FlexNav EU CE Mark Study [n = 46]) for the analysis. The primary endpoint was Valve Academic Research Consortium-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 an echocardiography core laboratory, respectively., Results: One hundred forty high-risk and 40 extreme-risk subjects enrolled between October 15, 2018, and December 10, 2019, from 28 sites in the United States, Australia, and Europe who underwent attempted transfemoral Portico valve implantation were included. The mean age was 85.1 ± 5.6 years, 60% were women, the mean Society of Thoracic Surgeons score was 5.3%, and 96.1% presented with ≥1 frailty factor. Technical device success was 96.7%. At 30 days, the rate of major vascular complications was 5.0%, with 4.4% of complications adjudicated as access site-related (3.3% transcatheter aortic valve replacement DS access site-related). Death (0.6%) and disabling stroke (1.1%) were rare. The rate of new permanent pacemaker implantation was 15.4%. Echocardiography revealed a mean gradient of 7.1 ± 3.2 mm Hg, mean valve area of 1.77 ± 0.41 cm 2 , and a 4.1% rate of moderate paravalvular leak at 30 days., Conclusions: Portico valve implantation with the FlexNav DS was associated with an excellent safety profile at 30 days., Competing Interests: Author Relationship With Industry Dr. Fontana is a consultant for and has received proctoring fees from Abbott, Medtronic, and LivaNova; is a member of the structural heart safety advisory board for Abbott; and is a principal investigator for Abbott and Medtronic. Dr. Bedogni has served as a consultant for Boston Scientific, Medtronic, and Abbott. Dr. Groh is a member of the structural heart safety advisory board for Abbott. Dr. Smith has received speaking fees and proctoring fees from Abbott. Dr. Chehab has received grant and research support from Abbott; and has received speaking and proctoring fees from Abbott, Edwards Lifesciences, Medtronic, and Boston Scientific. Dr. Yong is a physician proctor for Abbott Vascular, Medtronic, and Edwards Lifesciences. Dr. Worthley has received research grants from Abbott and Biotronik. Dr. Manoharan has served as a proctor for Boston Scientific, Medtronic, and Abbott. Dr. Walton is a proctor for Medtronic and Abbott; is a medical advisory board member for Medtronic; and has received grant support from Medtronic, Abbott, and Edwards Lifesciences. Dr. Hermiller is a physician proctor for Abbott. Dr. Dhar is a proctor for Abbott Vascular, Edwards Lifesciences, and Medtronic; has received a research grant from Boston Scientific; is a member of the interventional cardiology medical advisory board for Boston Scientific; and is a member of the Speakers Bureau for Boston Scientific. Dr. Waksman is an advisory board member for Amgen, Boston Scientific, Cardioset, Cardiovascular Systems, Medtronic, Philips, and Pi-Cardia; is a consultant for Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems, Medtronic, Philips, and Pi-Cardia; has received grant support from AstraZeneca, Biotronik, Boston Scientific, and Chiesi; is a Speakers Bureau member for AstraZeneca and Chiesi; and is an investor in MedAlliance. Dr. Ramana has received speaking, consulting, and proctoring fees from Edwards Lifesciences; has received consulting fees from Abbott and Medtronic; and has received research support from Boston Scientific. Dr. Mahoney is a consultant and proctor for Edwards Lifesciences; and is a consultant for Abbott. Dr. Asch is director of an academic echocardiography core laboratory that has institutional research contracts with Abbott, Edwards Lifesciences, Boston Scientific, Medtronic, LivaNova, Biotronik, and Vascular Innovations. Dr. Chakravarty is a consultant for Edwards Lifesciences, Medtronic, Abbott, and Boston Scientific. Dr. Jilaihawi has been a consultant to Boston Scientific and Medtronic; and has received grant and research support from Medtronic, Edwards Lifesciences, Abbott Vascular, and HLT, Inc. Dr. Makkar has received research grants and speaking and proctoring fees from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific. Dr. Garrett has reported that he has no relationships relevant to the contents of this paper to disclose., (Copyright © 2020. Published by Elsevier Inc.)

Background: The aim of the Portico TAVI (transcatheter aortic valve implantation) system study was to evaluate outcomes ≤1 year after implantation of a novel resheathable, self-expanding TAVI system in a multicenter patient population with severe aortic stenosis (AS)., Methods and Results: High-risk patients (n=222) with symptomatic severe AS (mean age, 83.0±4.6 years; 74.3% women) were enrolled across 12 centers in Europe and Australia. The study's primary end point was all-cause mortality at 30 days. A total of 209 patients who received the Portico TAVI system were available for follow-up after the 30-day visit. Data collection included hemodynamic assessment by echocardiography with core laboratory evaluation and assessment of functional status. Valve Academic Research Consortium-defined adverse events were adjudicated by an independent Clinical Events Committee. TAVI using the Portico valve led to a significant and persistent improvement in aortic valve function at 1 year. More than mild paravalvular leak was present in 5.7% and 7.5% of patients at 30 days and 1 year, respectively. Kaplan-Meier estimates at 30 days and 1 year were 3.6% and 13.8% for all-cause mortality, 3.6% and 9.6% for cardiovascular mortality, and 3.2% and 5.8% for major (disabling) stroke. After 30 days and ≤1 year of follow-up, adverse events included stage 3 acute kidney injury (n=3), major vascular complications (n=5), and life-threatening/disabling bleeding (n=3). Overall permanent pacemaker rate was 14.7%. At 1 year, 74.8% improved ≥1 New York Heart Association class compared with baseline ( P <0.0001)., Conclusions: The Portico TAVI system is safe and effective at 1 year, yielding low mortality and stroke rates in high-risk patients with severe AS., Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01493284., (© 2018 American Heart Association, Inc.)

Objectives: This study assessed the ability of the SYNTAX score (SXscore) to stratify risk in patients treated with percutaneous coronary intervention (PCI) using zotarolimus-eluting or everolimus-eluting stents., Background: The SXscore can identify patients treated with PCI who are at highest risk of adverse events., Methods: The SXscore was calculated prospectively in 2,033 of the 2,292 patients enrolled in the RESOLUTE All Comers study (RESOLUTE III All Comers Trial: A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention). Clinical outcomes in terms of a patient-oriented composite endpoint (POCE) of all-cause death, myocardial infarction (MI), and repeat revascularization; the individual components of POCE; target lesion failure (TLF) (a composite of cardiac death, target-vessel MI, and clinically driven target lesion revascularization); and stent thrombosis were subsequently stratified according to SXscore tertiles: SXscore(LOW) ≤ 9 (n = 698), 9 17 (n = 659)., Results: At 12-month follow-up, rates of POCE, MI, repeat revascularization, TLF, and the composite of death/MI were all significantly higher in patients in the highest SXscore tercile. Rates of stent thrombosis were all highest in the SXscore(HIGH) tertile (p > 0.05). After multivariate adjustment, the SXscore was identified as an independent predictor of POCE, MI, repeat revascularization, and TLF (p < 0.05 for all). At 12-month follow-up, the SXscore, ACEF score, and Clinical SXscore had C-statistics of 0.57, 0.78, and 0.67, respectively, for mortality and of 0.62, 0.56, 0.63, respectively, for POCE. No significant between-stent differences were observed for TLF or POCE in any of the SXscore tertiles., Conclusions: The SYNTAX score is able to stratify risk amongst an all-comers population treated with PCI with second-generation drug-eluting stents (DES); however, improvements can be made with the inclusion of clinical variables. (RESOLUTE III All Comers Trial: A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention; NCT00617084)., (Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)