Flow rate variance of a fully implantable pump for the delivery of intravenous treprostinil in pulmonary arterial hypertension

Richter, Manuel J.; Harutyunova, Satenik; Bollmann, Tom; Claßen, Simon; Fuge, Jan; Gall, Henning; Gerhardt, Felix; Ghofrani, Hossein A.; Gunkel, H; Grünig, Ekkehard; Halank, Michael; Heine, Alexander; Klose, Hans; Lange, Tobias; Neurohr, C; Nickolaus, Kai; Opitz, Christian; Rosenkranz, Stephan; Tello, Khodr; Ewert, Ralf; Olsson, Karen M.

doi:10.1177/2045894020910136

Cited by 6 publications

(4 citation statements)

References 13 publications

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“…Richter and coworkers recently showed that flow rate increase above the upper limit of technical deviation (7.5%) is evident after three years. 8 These results are consistent with the findings in our cohort. However, we have seen increasing flow rate as early as 12–15 months after implantation in single pumps.…”

supporting

confidence: 93%

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Long‐term experience with implantable infusion pumps for intravenous treprostinil in pulmonary arterial hypertension—procedural safety and system‐related complications

Steringer‐Mascherbauer

Lummersdorfer

Függer

et al. 2020

Pulm. circ.

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supporting

confidence: 93%

“…As already published by other groups[5][6][7] this increase occurs gradually over time. Richter and coworkers recently showed that flowrate increase above the upper limit of technical deviation (7,5%) is evident after three years8 . These results are consistent with the findings in our cohort.…”

mentioning

confidence: 97%

Long‐term experience with implantable infusion pumps for intravenous treprostinil in pulmonary arterial hypertension—procedural safety and system‐related complications

Steringer‐Mascherbauer

Lummersdorfer

Függer

et al. 2020

Pulm. circ.

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“…Interestingly, the extent of flow rate variability over the technical lifetime of the LENUS Pro ® pump obviously has the potential to cause life-threatening events, as observed in 1 patient who suffered from severe rebound after the pump’s reservoir had been emptied before the scheduled refill. In this context, a recent multicenter study showed that in the initial phase, the pump’s flow rate was significantly lower than the expected rate (as specified by the manufacturer) and increased slowly but steadily with long-term use, significantly exceeding the expected rate in the end [23]. Hence, frequent assessments of the flow rate and compensatory adjustments of the treprostinil dose are considered mandatory and should be performed by experts.…”

Section: Discussionmentioning

confidence: 99%

Long-Term Safety, Outcome, and Clinical Effects of Subcutaneous and Intravenous Treprostinil Treatment in Patients with Severe Chronic Pulmonary Arterial Hypertension

Harutyunova¹,

Benjamin²,

Eichstaedt³

et al. 2023

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Background: Current guidelines recommend treatment with parenteral prostacyclin analogs in patients with severe pulmonary arterial hypertension (PAH), who have insufficient response to treatment. Real-life data are sought to help physicians in treatment decisions and clinical care of patients. Objective: This study analyzed safety, clinical effects, and long-term outcomes of subcutaneous (sc) and/or intravenous (iv) treprostinil via different pump systems in consecutive patients with PAH. Methods: Thirty-seven patients with severe progressive PAH despite dual combination therapy (20 female, mean age: 52.3 ± 15 years, mean pulmonary vascular resistance: 12.1 ± 5.1 WU) were initiated with add-on treprostinil sc and were routinely clinically assessed. Changes in clinical parameters, adverse events, and outcome were analyzed retrospectively. Results: In 24 of 37 patients, treprostinil administration was continued iv via implantation of LENUS Pro® pump after 3 ± 1.3 months, 6 patients continued with sc therapy, and 7 discontinued treatment. After 3, 6, 9, and 12 months of treprostinil treatment, patients showed a significant improvement in mean 6-min walk distance and tricuspid annular plane systolic excursion compared to baseline. In 8 of the 24 patients, iv pumps required surgical revision. During a mean follow-up of 2.82 ± 1.95 years, 12 patients died, four received lung transplantation. Transplant-free survival after 1, 2, and 3 years was 85.7%, 69.2%, and 65.3%, respectively. Conclusion: sc treprostinil as add-on to double combination treatment significantly improved exercise capacity and right heart function. In most patients, treprostinil could be continued via more tolerable iv administration approach (LENUS Pro® pump), showing reasonable overall survival with respect to the severity of PAH.

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“…Recently, the variance of the fixed flow rate during longterm follow-up has been addressed on 126 patients (12) during a median follow-up of 12 months. Based on 2,853 refills, the relative flow rate deviation between each individual refill was between −10% and +10% in 94.5% of cases.…”

Section: Discussionmentioning

confidence: 99%

Unexpected Acceleration in Treprostinil Delivery Administered by a Lenus Pro® Implantable Pump in Two Patients Treated for Pulmonary Arterial Hypertension

Kopp¹,

Hachulla

Noble

et al. 2020

Front. Med.

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Intravenous treprostinil administration by an implantable pump is an attractive option for pulmonary arterial hypertension (PAH) treatment and is the subject of recent publications. Short-term studies are promising, but there is still a lack of long-term prospective data. We analyzed the treprostinil flow rate administered by the Lenus Pro® implantable pump in 2 patients suffering from PAH during follow-up times of respectively 4.2 and 3 years. The flow rate delivered by the pumps in these 2 patients exceeded the manufacturer admitted margin of error within 2 years and continued to increase to reach, respectively, 158 and 120% of the expected flow rate at the end of the follow up. In one case, the implantable pump had to be removed for this reason. The ex-vivo flow rate of the withdrawn pump determined in the laboratory reached 173% of the predicted value. This correlated with the in-vivo measurement, which suggests a continuous flow increase even after pump removal and without treprostinil use. Spontaneous flow increase from such an implantable pump is a potentially major pitfall, which needs to be identified and actively managed by the responsible clinicians.

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Flow rate variance of a fully implantable pump for the delivery of intravenous treprostinil in pulmonary arterial hypertension

Cited by 6 publications

References 13 publications

Long‐term experience with implantable infusion pumps for intravenous treprostinil in pulmonary arterial hypertension—procedural safety and system‐related complications

Long‐term experience with implantable infusion pumps for intravenous treprostinil in pulmonary arterial hypertension—procedural safety and system‐related complications

Long-Term Safety, Outcome, and Clinical Effects of Subcutaneous and Intravenous Treprostinil Treatment in Patients with Severe Chronic Pulmonary Arterial Hypertension

Unexpected Acceleration in Treprostinil Delivery Administered by a Lenus Pro® Implantable Pump in Two Patients Treated for Pulmonary Arterial Hypertension

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