Long-term safety and outcome of intravenous treprostinil via an implanted pump in pulmonary hypertension

Richter, Manuel J.; Harutyunova, Satenik; Bollmann, Tom; Claßen, Simon; Gall, Henning; Gerhardt, Felix; Grimminger, Friedrich; Grimminger, Jan; Grünig, Ekkehard; Guth, Stefan; Halank, Michael; Heine, Alexander; Hoeper, Marius M.; Klose, Hans; Lange, Tobias; Meyer, Katrin; Neurohr, Claus; Nickolaus, Kai; Olsson, Karen M.; Opitz, Christian; Rosenkranz, Stephan; Warnke, Christian; Wiedenroth, Christoph B.; Ghofrani, Hossein Ardeschir; Ewert, Ralf

doi:10.1016/j.healun.2018.06.006

Cited by 31 publications

(35 citation statements)

References 28 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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“…The LENUS Pro Õ implantable pump (Tricumed Medizintechnik GmbH, Kiel, Germany) is approved in Europe for intravenous treprostinil administration and has a fixed flow rate. [3][4][5][6][7] Treprostinil solution is injected into a drug reservoir within the pump via a silicone septum, and a gas-driven titanium bellows generates a constant flow from the reservoir regulated by a chip capillary. 7 In routine clinical practice, percutaneous refills are performed under aseptic conditions using specifically designed refill needles either at the referral center or by a specialized healthcare service in the patient's home, based on local availability.…”

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confidence: 99%

“…In the recently published long-term safety study of the LENUS Pro Õ pump, variances of the non-adjustable flow rate were classified as pump defects. 5 However, clinically relevant events (defined as serious adverse events leading to hospitalization or pump exchange) caused by extreme flow rate variance were reported for only two of 129 pumps during long-term follow-up: in one case, the variance of flow rate resulted in cardiogenic shock requiring pump replacement, and in the other case, the patient developed cardiac decompensation but recovered without requiring pump replacement (instead, the treprostinil dosage was adjusted to the increased flow rate). 5 Those rare (0.1% in the present study) but extreme individual deviations from the previous refill might be able to trigger a Less than −10% −10% to 10% More than 10% Flow rate deviation relative to the previous refill Fig.…”

mentioning

confidence: 99%

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

Richter

Harutyunova

Bollmann³

et al. 2020

Pulm. circ.

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Implantable infusion pumps might improve the convenience and safety of intravenous treprostinil for pulmonary arterial hypertension. The LENUS Pro® pump (approved in Europe) has a fixed flow rate. Based on 126 pumps and 2853 refills, we retrospectively analyzed the actual flow rate from 09/2010 to 09/2018. A relevant flow rate variance is evident after three years; therefore, flow rate monitoring and dose adjustment are mandatory.

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“…This increase in the capillary canal cross‐section is a slow process that can happen after several years of use. In the multicenter study reporting the implantation and long‐term follow‐up in 129 adult patients, this kind of pump dysfunction was observed in 5 of 129 patients, where pump exchange was required in four cases 9 . The authors reported a pump‐related side effects rate of 0.07/1000 treatment days 9 .…”

Section: Discussionmentioning

confidence: 99%

“…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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Long-term safety and outcome of intravenous treprostinil via an implanted pump in pulmonary hypertension

Cited by 31 publications

References 28 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

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

Implantable LENUS pro pump for treprostinil infusion in three pediatric patients

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