One-Year Results from Real-World Study Showed Abbott's Portico™ Transcatheter Aortic Valve Safely and Successfully Reduced Severe Aortic Stenosis
The one-year results from the PORTICO I study were presented during a late-breaking session at the 30th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the
The Portico transcatheter valve is a minimally invasive alternative to surgical aortic valve replacement for patients diagnosed with severe aortic stenosis who are high-risk candidates for open-heart surgery. Aortic stenosis is a common and life-threatening valve disease in which the aortic valve opening in the heart narrows and restricts blood flow from the left ventricle to the aorta. More than one in eight people aged 75 and older have moderate or severe aortic stenosis,[1] which reduces the heart's pumping ability. Most patients don't have symptoms for decades, but once symptoms appear, the prognosis is poor without surgical treatment,[2] manifesting in shortness of breath, fatigue, and ultimately heart failure.[3]
"Portico offers physicians the ability to safely and successfully treat patients suffering from symptomatic, severe aortic stenosis with a high level of confidence," said
In this study, at one year, patients who received a Portico valve had low rates of mortality, stroke, paravalvular leak, and sustained significantly improved hemodynamic performance. All-cause and cardiovascular mortality were 12.1 percent and 6.6 percent, respectively; disabling stroke was observed in 2.2 percent of patients and myocardial infarction in 2.5 percent. Mean aortic valve area increased from baseline (0.72 ± 0.37 cm2) to 30 days (1.79 ± 0.48 cm2) and was durable at one year (1.74 ± 0.49 cm2). Moderate paravalvular leak was low, decreasing from 3.9 percent of patients at 30 days to 2.6 percent of patients at one year. The proportion of patients classified with severe heart failure (NYHA Class III/IV[4]) decreased from 63.8 percent at baseline to 7.7 percent at one year.
"These real-world data demonstrate that Portico is safe and performs as intended to help patients suffering from severe aortic stenosis," said
The PORTICO I trial is an ongoing, prospective, long-term study of patients with symptomatic, severe aortic stenosis treated with the self-expanding, repositionable Portico transcatheter aortic valve via a transfemoral access. The primary endpoint is all-cause mortality at one year. Secondary endpoints include device performance, improvement in functional capacity, and adverse event rates at 30 days, one year, and annually thereafter, for five years. The study is evaluating 941 patients treated between
Abbott recently received regulatory approval in
Abbott received CE Mark for Portico in 2012, and has completed enrollment in the randomized treatment arm of a U.S. pivotal study.
The Portico Transcatheter Aortic Valve is approved for investigational use only in the U.S.
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[1] Nkomo VT, Gardin JM, Skelton TN, et al. Burden of valvular heart diseases: a population-based study. Lancet 2006;368:1005-11
[2] Nardi P, Russo M, Saitto G, et al. The Treatment of Aortic Valve Stenosis in Patients at Intermediate-High Risk. Interv Cardiol J. 2016, 2:2.
[3] Osnabrugge RLJ, Mylotte D, Head SJ, et al; Aortic Stenosis in the Elderly: Disease Prevalence and Number of Candidates for Transcatheter Aortic Valve Replacement: A Meta-Analysis and Modeling Study.
[4] https://www.heart.org/en/health-topics/heart-failure/what-is-heart-failure/classes-of-heart-failure
[5] Taramasso et al. "Feasibility and safety of Transfemoral Sheathless Portico Aortic Valve Implantation." Catheter Cardiovasc Interv. 2017 May 13. doi: 10.1002/ccd.271005.
[6] Bruschi et al. "Portico Sheathless Transcatheter Aortic Valve Implantation via Distal Axillary Artery." Ann Thorac Surg. 2017 Feb;103(2):e175-e177. doi: 10.1016/j.athoracsur.2016.07.065
[7] Denegri et al. "Real-world procedural and 30-day outcome using the Portico transcatheter aortic valve prosthesis:" Int J Cardiol. 2018 Feb 15;253:40-44. doi: 10.1016/j.ijcard.2017.10.101. Epub 2017 Nov 10
[8] Taramasso M. Feasibility and Safety of Transfemoral Sheathless Portico Aortic Valve Implantation: Prelimary Results in a Single Center Experience Catheterization and Cardiovascular Interventions 91:533–539 (2018).
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