Key result
Intracorporeal loop positioning fails to improve driveline infection rates in LVAD recipients.
Why the study?
The effect of intracorporeal loop positioning versus no intracorporeal loop positioning on driveline infection prevention in LVAD recipients was uncertain.
Does intracorporeal loop positioning reduce driveline infection in patients with a left ventricular assist device implant?
RCT (n=80)
Open-label
Does intracorporeal loop positioning reduce driveline infection in patients with a left ventricular assist device implant?
Absolute Event Rate: 51% vs 62%
p-value: p=0.33
Intracorporeal loop positioning of the driveline does not significantly reduce the risk of driveline infection at 1 year in LVAD recipients compared to no loop positioning.
Does not support intracorporeal loop positioning to prevent driveline infection in LVAD recipients; confirms no benefit in this RCT.
We conducted a prospective, open-labeled, clinical trial, with a two-by-two factorial design, of argon cold plasma application and two different types of driveline positioning for the prevention of driveline infection (DLI) in 80 patients with a left ventricular assist device (LVAD) implant. Here, we present the results of intracorporeal loop positioning ( n = 40) versus no intracorporeal loop positioning ( n = 40). Patients were followed up for 1 year. According to the Driveline Expert STagINg and carE grading (DESTINE) system, a DLI was considered in case of a stage 2 or higher graded infection. During follow-up, 29 (36%) patients experienced a DLI, 16 in the group with intracorporeal loop positioning and 13 in the group with no intracorporeal loop positioning. Kaplan-Meier estimates of freedom from DLI showed no statistically significant difference between study groups during follow-up ( p = 0.33). In detail, 30-day freedom from DLI was for the groups with and without intracorporeal loop positioning 92 and 92%, respectively, and 1-year freedom from DLI was 51 and 62%, respectively. In conclusion, this controlled clinical trial was unable to show a statistically significant difference in freedom from DLI during one year of follow-up in groups with or without intracorporeal loop positioning. However, larger trials have to confirm these results.
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Lauenroth et al. (2024) conducted an RCT in Left ventricular assist device (LVAD) implant (n=80). Intracorporeal loop positioning vs. No intracorporeal loop positioning was evaluated on 1-year freedom from driveline infection (p=0.33). Intracorporeal loop positioning did not significantly improve 1-year freedom from driveline infection compared to no loop positioning in LVAD recipients (51% vs 62%; p=0.33).
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