Intravenous treprostinil infusion via a fully implantable pump for pulmonary arterial hypertension

Ewert, Ralf; Richter, Manuel J.; Steringer‐Mascherbauer, Regina; Grünig, Ekkehard; Lange, Tobias; Opitz, Christian; Warnke, Christian; Ghofrani, Hossein Ardeschir

doi:10.1007/s00392-017-1114-1

Cited by 21 publications

(18 citation statements)

References 32 publications

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“…Afterward, treprostinil was administered via a fully implantable pump (Lenus Pro, Tricumed Medizintechnik GmbH, Kiel, Germany) with further individual dose adjustments targeting the highest tolerated dose. 19,20…”

Section: Intravenous Treprostinil Treatmentmentioning

confidence: 99%

Intravenous treprostinil as an add-on therapy in patients with pulmonary arterial hypertension

Olsson

Richter

Kamp

et al. 2019

The Journal of Heart and Lung Transplantation

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BACKGROUND: In patients with pulmonary arterial hypertension who have an insufficient response to oral or inhaled therapies, current guidelines recommend the use of parenteral prostacyclin analogues, although the efficacy of this approach is unknown. METHODS: This retrospective multicenter study evaluated patients with pulmonary arterial hypertension who received intravenous treprostinil as an add-on therapy. The risk at baseline and follow-up (6−12 months after the initiation of treprostinil) was classified as low, intermediate, or high according to current recommendations. The outcome was measured as transplant-free survival after the initiation of treprostinil therapy. RESULTS: A total of 126 patients were analyzed, almost all of them pre-treated with combinations of other pulmonary arterial hypertension medications. Before the initiation of intravenous treprostinil, 2 (2%) patients had a low-risk profile; 100 (79%), an intermediate-risk profile; and 24 (19%), a highrisk profile. At follow-up, 24 (19%) patients were classified as low-risk. These patients had a 5-year transplant-free survival rate >90%. In contrast, patients who remained at intermediate or high risk had transplant-free survival rates of 76%, 43%, and 28% at 1, 3, and 5 years, respectively. Failure to reach a low risk at follow-up was an independent predictor of transplant-free survival (hazard ratio, 9.25; 95% confidence interval, 1.20−71.60; p = 0.033 1). CONCLUSIONS: Risk assessment at 6−12 months after the initiation of add-on intravenous treprostinil in patients with an insufficient response to nonparenteral treatments allows the prediction of transplantfree survival over the ensuing years. Achieving a low-risk profile is associated with excellent outcomes, whereas mortality is high in patients who remain at intermediate or high risk.

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Section: Intravenous Treprostinil Treatmentmentioning

confidence: 99%

Intravenous treprostinil as an add-on therapy in patients with pulmonary arterial hypertension

Olsson

Richter

Kamp

et al. 2019

The Journal of Heart and Lung Transplantation

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“…To date, there is mainly experience with the Lenus pro pump for treprostinil administration in adults with PAH, 7–9 and there is only one pediatric case, using the 20 mL pump, that has been reported 10 …”

Section: Introductionmentioning

confidence: 99%

Implantable LENUS pro pump for treprostinil infusion in three pediatric patients

Álvarez-Fuente¹,

Garrido‐Lestache²,

Rivero³

et al. 2020

Pediatric Pulmonology

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Background Prostanoid treatment in patients with severe pulmonary arterial hypertension (PAH) has been proven safe and effective. Subcutaneous administration of treprostinil has side effects, which limits their use and acceptance. An implantable pump for continuous intravenous treprostinil infusion has been recently approved. We describe our experience with the implantable pump in three pediatric patients. Description of Cases The LENUS pro pump was implanted in three adolescents with severe PAH, who were treated with tadalafil, ambrisentan, and subcutaneous treprostinil. The indication of the Lenus pro pump implantation was the local side effects of subcutaneous treprostinil (pain, inflammation, and local infection) that were not well tolerated and that severely decreased their quality of life. The pump was surgically implanted under general anesthesia.One patient, in functional class IV, suffered postoperative hemodynamic instability and small pneumothorax, requiring an increase in treprostinil dose up to 85 ng/kg/min and a decrease 9 days after the pump implantation. The second patient who was discharged 4 days after surgery with treprostinil at 60 ng/kg/min reported improvement in his quality of life, but the dose requirement increased up to 92 ng/kg/min. After a 21‐month follow‐up, this patient received a lung transplant. The third patient presented a hematoma at the pump site with no other complications and had a follow‐up of 9 months with an improvement in her quality of life. Comments Implantable pumps for continuous parenteral prostanoid infusion in pediatric patients are an alternative to external pumps, especially when familiar psychological or psychomotor issues hinder the use of external pumps.

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“…However, in 5-10 % of patients, this treatment has to be discontinued due to a strong local reaction associated with signifi cant pain at the application site. The intravenous administration of treprostinil via an implantable Lenus Pro pump may be a suitable solution for such patients (8)(9)(10). The pump is implanted subcutaneously in the right upper abdominal quadrant, and connected to a tunneled catheter leading into the superior vena cava.…”

Section: Introductionmentioning

confidence: 99%

Long-term experience with implantable treprostinil pumps in pulmonary arterial hypertension

Dytrych¹,

Kuchař²,

Ambrož³

et al. 2020

BLL

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OBJECTIVES: To compare clinical parameters and quality of life in patients with pulmonary arterial hypertension (PAH) at the time of diagnosis, at the time of LenusPro pump implantation and during intravenous treptostinil treatment. METHODS: Seven patients with severe PAH treated with intravenous treptostinil via implantable LenusPro pumps were evaluated, including NYHA classifi cation, six-minute walking test, BNP and quality of life assessment using the EQ-5D-5L questionnaire before and after pump implantation. RESULTS: No signifi cant changes were observed in NYHA class and six-minute walking distance test. There was however a signifi cant improvement in the quality of life and a decrease in BNP levels. The mean EQ-5D-5L index assessed during subcutaneous treptostinil treatment was signifi cantly worse when compared to that assessed during its intravenous application (0.39 ± 0.24 vs 0.78 ± 0.28, p ˂ 0.05); the same is true about the pain/discomfort dimension. Complications occurred, namely one nonfatal pneumothorax, one nonfatal hemothorax, and one event of nonfatal treptostinil intoxication after refi lling. CONCLUSIONS: In patients who do not tolerate subcutaneous treptostinil treatment, the use of the LenusPro implantable pump results in a signifi cant improvement in quality of life with an acceptable safety profi le (Tab. 2, Fig. 2, Ref. 19).

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Intravenous treprostinil infusion via a fully implantable pump for pulmonary arterial hypertension

Abstract: This study supports use of a fully implantable treprostinil infusion pump in patients with PAH requiring parenteral prostanoids. Refills should be performed by specialized healthcare professionals at patients' homes or at experienced centers using approved equipment.

Cited by 21 publications

References 32 publications

Intravenous treprostinil as an add-on therapy in patients with pulmonary arterial hypertension

Intravenous treprostinil as an add-on therapy in patients with pulmonary arterial hypertension

Implantable LENUS pro pump for treprostinil infusion in three pediatric patients

Long-term experience with implantable treprostinil pumps in pulmonary arterial hypertension

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