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Transcatheter Valve Shown Feasible in First-in-Human Use
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A repositionable transcatheter heart valve was shown to be feasible and lead to good short-term and hemodynamic outcomes in a first-in-human study.
The 23-mm valve (Portico, St. Jude Medical) features a nitinol self-expanding frame, bovine pericardial leaflets, porcine pericardial sealing cuff and the ability to be repositioned following deployment. According to the study, suboptimal prosthesis positioning may contribute to paravalvular regurgitation, atrioventricular conduction block and mitral or coronary compromise.
In all, the valve was implanted in 10 high-risk patients with severe symptomatic aortic stenosis. Researchers performed prosthesis recapture and repositioning in four patients.
Clinical and echocardiographic follow-up at 30 days revealed that no patients had major strokes, major vascular complications, major bleeds or deaths, and one patient had a minor stroke and one had a minor vascular complication (hematoma). Researchers also observed an echocardiographic mean transaortic gradient reduction from 44.9 ± 16.7 mm Hg to 10.9 ± 3.8 mm Hg (P<.001), and an increase in valve area from 0.6 ± 0.1 cm2 to 1.3 ± 0.2 cm2 (P<.001). All patients were in NYHA functional Class I (n=6) or II (n=4) at follow-up, and nine had mild or less paravulvular regurgitation, with the other patient having moderate paravulvular regurgitation.
Perspective
Back to TopJonathan C. Fong, MD
Jonathan C. Fong
This first-in-human article describes a two-institution experience with the St. Jude Portico valve. Transcatheter technology provides an additional tool for the treatment of aortic stenosis. Ten patients were deemed inoperable mostly due to frailty (7/10). Success as defined by successful deployment and alleviation of stenosis was accomplished in all 10 patients. There was no 30-day mortality, and valve function in the short term was excellent. The added functionality of being able to be recaptured and repositioned advances the development of transcatheter devices. Longer-term studies will be needed to establish durability, and long-term follow-up of the patients will determine whether they have benefited from both a functional as well as a survival standpoint.
The study answers the basic question of "Can it be done?" Another question still remains: "What is truly the definition of 'inoperability'?" The answer varies greatly from one institution to another. Ultimately, the question may be moot, as patients may decide to seek transcatheter solutions solely based upon ease of recovery as opposed to long-term durability or survival. Interestingly, the study was performed in a country with a national health system which will decide what technology will be available for which patients.
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