Abstract:BackgroundThe DelIVery for Pulmonary Arterial Hypertension clinical trial was a
multi-center, prospective, single arm, Investigational Device Exemption
study utilizing a fully implantable, programmable intravascular delivery
system consisting of a pump and a catheter for intravenous treprostinil. The
study met its primary endpoint and demonstrated that the intravascular
delivery system significantly reduced catheter related complications at
22,000 subject-days of follow-up compared with a predefined objective
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“…Bourge et al observed a decreasing flow rate with subsequent adjustment of the dose, and noted that this was at least partly attributable to ''back pressure'' from the special catheter 10 used in their study. 11,12 In conclusion, during long-term application of intravenous treprostinil via the fully implantable LENUS Pro Õ pump, the actual flow rate differs from the distributor-specified fixed flow rate, starting below the expected rate in early months and increasing slowly but steadily above the expected rate with longer term use. Taking into account previous publications, 3,5,9 the results of this study show that the variance has the potential to cause clinically relevant events.…”
mentioning
confidence: 96%
“…observed a decreasing flow rate with subsequent adjustment of the dose, and noted that this was at least partly attributable to “back pressure” from the special catheter 10 used in their study. 11,12…”
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.
“…Bourge et al observed a decreasing flow rate with subsequent adjustment of the dose, and noted that this was at least partly attributable to ''back pressure'' from the special catheter 10 used in their study. 11,12 In conclusion, during long-term application of intravenous treprostinil via the fully implantable LENUS Pro Õ pump, the actual flow rate differs from the distributor-specified fixed flow rate, starting below the expected rate in early months and increasing slowly but steadily above the expected rate with longer term use. Taking into account previous publications, 3,5,9 the results of this study show that the variance has the potential to cause clinically relevant events.…”
mentioning
confidence: 96%
“…observed a decreasing flow rate with subsequent adjustment of the dose, and noted that this was at least partly attributable to “back pressure” from the special catheter 10 used in their study. 11,12…”
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.
“…Moreover, it should be kept in mind that patients with advanced PAH represent a group at highrisk for general anesthesia. Several papers have shown that the procedure may be associated with fatal complications, especially unmanageable right-sided heart failure (11)(12)(13)(14). It is therefore crucial that the procedure is performed in centers experienced in the treatment of pulmonary hypertension and that the general anesthesia is conducted by an experienced anesthetist.…”
Section: Discussionmentioning
confidence: 99%
“…The dosage can be adjusted by using various concentrations of treprostinil loaded into the pump reservoir. So far, several papers have shown that the pump implantation is relatively safe with a low risk of periprocedural complications (11)(12)(13)(14). The long-term treatment has been also shown to be safe while complications such as local infections at the site of pump implantation, catheter obstruction associated with the risk of discontinuation of treprostinil therapy, and increased pump output associated with the risk of an increased amount of applied treprostinil due to a pump failure are relatively rare.…”
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).
“…Long-term results of the DelIVery study were recently published, further demonstrating the safety profile of the implantable system over approximately 282 patient-years. 27 Investigators recommend continued patient treatment at specialized PAH centers to preserve the risk-benefit ratio of the implantable system, until training is disseminated to other sites. Fig 1.Overview of the Implantable System for Remodulin.…”
Parenteral prostanoids are effective for improving outcomes in patients with pulmonary arterial hypertension. However, subcutaneous or intravenous delivery via an external pump places a significant burden on patients. Consequently, the Implantable System for Remodulinß (treprostinil) was developed and is associated with a low rate of complications (United Therapeutics (Research Triangle Park, NC) in collaboration with Medtronic, Inc. (Mounds View, MN)). The current real-world experience study evaluated pulmonary arterial hypertension patients' perceptions of their quality of life, ability to perform activities of daily living, perceptions on the benefits and risks of the implantable system, and their social interactions before and after receiving the implantable system. Pulmonary arterial hypertension patients who had been transitioned from an external infusion pump to the implantable system completed a mix of quantitative and qualitative questions administered online over the course of a six-day period. A total of 20 patients completed the study. All patients reported that their quality of life, confidence out in public, and ability to travel long distances had improved. Over 90% of patients reported that their overall level of independence was better since receiving the implantable system, and most patients indicated that their ability to independently perform specific activities of daily living had improved. Responses to the qualitative questions suggested that the implantable system saved time, improved interpersonal relationships, and increased freedom. Results from this real-world patient experience study suggest this novel delivery system provides improvements in factors that are of substantial importance to patients.
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