Key result
Clinical surveillance of the Novacor LVAS demonstrated 91.5% freedom from wear at 3 years, which broadly paralleled the 87.4% freedom from wear observed in earlier in vitro testing.
Why the study?
Does the clinical long-term performance and wear of the Novacor LVAS parallel demonstrated in vitro reliability in patients implanted for more than 1 year?
Population
37 recipients of the Novacor wearable left ventricular assist system (LVAS) implanted for more than 1 year
Comparison
Novacor wearable left ventricular assist system… vs In vitro reliability/durability testing of the…
Design
Cohort
Follow-up
1 to 3 years
Authors
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Supports Novacor LVAS durability in extended use; hypothesis-generating and should not yet alter surveillance.
Observational (n=37)
Does the clinical long-term performance and wear of the Novacor LVAS parallel demonstrated in vitro reliability in patients implanted for more than 1 year?
Absolute Event Rate: 91.5% vs 87.4%
Clinical surveillance of the Novacor LVAS demonstrates long-term durability and wear patterns that closely parallel in vitro reliability testing, enabling elective replacement.
Wheeldon et al. (2002) conducted an observational in Heart failure requiring left ventricular assist system (n=37). Novacor LVAS vs. In vitro testing was evaluated on Freedom from wear at 3 years. Clinical surveillance of the Novacor LVAS demonstrated 91.5% freedom from wear at 3 years, which broadly paralleled the 87.4% freedom from wear observed in earlier in vitro testing.
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