The Infection Risk of Intrathecal Drug Infusion Pumps after Multiple Refill Procedures

Dario, Alessandro; Scamoni, C; Picano, Marco; Fortini, Gianpaolo; Cuffari, Salvatore; Tomei, G.

doi:10.1111/j.1094-7159.2005.05218.x

Cited by 26 publications

(20 citation statements)

References 19 publications

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“…Among these, 52 articles were excluded from both the effectiveness and complications review based on the same criterion: 26 because they were case reports ; 13 because they did not report data separately for patients with programmable IDDS, 39-51 9 because >10% of the sample had spasticity or a specific disease [52][53][54][55][56][57][58][59][60] ; and 4 because they focused only on patients who had not responded to their first IDDS drug. [61][62][63][64] (Where there was more than 1 reason for exclusion, we noted only the first reason identified.)…”

Section: Search Resultsmentioning

confidence: 99%

Programmable Intrathecal Opioid Delivery Systems for Chronic Noncancer Pain: A Systematic Review of Effectiveness and Complications

Turner¹,

Sears

Loeser

2007

The Clinical Journal of Pain

140

120

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The studies reviewed found improvement in pain and functioning on average among patients with chronic noncancer pain who received permanent IDDS. However, their methodologic limitations preclude conclusions concerning the effectiveness of this technology long-term and as compared with other treatments. Drug side effects and hardware complications were common. Suggestions are made for methodologic improvements in future studies.

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Section: Search Resultsmentioning

confidence: 99%

Programmable Intrathecal Opioid Delivery Systems for Chronic Noncancer Pain: A Systematic Review of Effectiveness and Complications

Turner¹,

Sears

Loeser

2007

The Clinical Journal of Pain

140

120

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“…A further option to avoid SC infusion site pain and minimise the risk of blood stream infections associated with the presence of an in-dwelling central venous catheter is to deliver IV treprostinil via an implanted infusion pump device, which has been successfully used both in neurology for intrathecal or epidural therapy and for the treatment of patients with PAH [15,16,17]. The application, safety and tolerability of implantable pumps for IV treprostinil therapy in PAH patients is currently being investigated.…”

Section: Discussionmentioning

confidence: 99%

Safety, Tolerability and Clinical Effects of a Rapid Dose Titration of Subcutaneous Treprostinil Therapy in Pulmonary Arterial Hypertension: A Prospective Multi-Centre Trial

Grünig

Benjamin

Lange³

et al. 2016

Respiration

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Background: Subcutaneous treprostinil has dose-dependent beneficial effects in patients with severe pulmonary arterial hypertension, but adverse effects like infusion site pain can lead to treatment discontinuation. Objectives: The objective of this study was to evaluate safety, tolerability and clinical effects of a rapid up-titration dosing regimen of subcutaneous treprostinil using proactive infusion site pain management. Methods: Effects of rapid up-titration dosing regimen on tolerability and clinical parameters were evaluated in this 16-week, open-label multi-centre study. Results: Thirty-nine patients with idiopathic or heritable pulmonary arterial hypertension on stable treatment with oral pulmonary arterial hypertension-approved drugs (90% on dual combination therapy) were included. Patients achieved a median treprostinil dosage of 35.7 ng/kg/min after 16 weeks. A good overall safety profile was demonstrated with 3 patients (8%) withdrawing due to infusion site pain, which occurred in 97% of patients. After 16 weeks, median 6-min walking distance, cardiac index, pulmonary vascular resistance, and tricuspid annular plane systolic excursion improved. Conclusions: Rapid up-titration of subcutaneous treprostinil was well tolerated, achieving a clinically effective dose associated with improvement of exercise capacity and haemodynamics after 16 weeks. A rapid dose titration regimen and proactive infusion site pain management may improve the handling of this therapy and contribute to better treatment outcome.

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“…A further option to avoid SC infusion site pain and minimise the risk of blood stream infections associated with the presence of an in-dwelling central venous catheter is to deliver IV treprostinil via an implanted infusion pump device, which has been successfully used both in neurology for intrathecal or epidural therapy and for the treatment of patients with PAH [15][16][17] . The application, safety and tolerability of implantable pumps for IV treprostinil therapy in PAH patients is currently being investigated.…”

Section: Discussionmentioning

confidence: 99%

Safety, tolerability and clinical effects of a rapid dose titration of subcutaneous treprostinil therapy in pulmonary arterial hypertension: a prospective multi-centre trial.

et al. 2016

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arterial hypertension on stable treatment with oral pulmonary arterial hypertension-approved drugs (90% on dual combination therapy) were included. Patients achieved a median treprostinil dosage of 35.7 ng/kg/min after 16 weeks. A good overall safety profile was demonstrated with 3 patients (8%) withdrawing due to infusion site pain, which occurred in 97% of patients. After 16 weeks, median 6-min walking distance, cardiac index, pulmonary vascular resistance, and tricuspid annular plane systolic excursion improved. Conclusions: Rapid up-titration of subcutaneous treprostinil was well tolerated, achieving a clinically effective dose associated with improvement of exercise capacity and haemodynamics after 16 weeks. A rapid dose titration regimen and proactive infusion site pain management may improve the handling of this therapy and contribute to better treatment outcome. © 2016 S. Karger AG, Basel Key Words Treprostinil · Pulmonary arterial hypertension · Subcutaneous infusionAbstract Background: Subcutaneous treprostinil has dose-dependent beneficial effects in patients with severe pulmonary arterial hypertension, but adverse effects like infusion site pain can lead to treatment discontinuation. Objectives: The objective of this study was to evaluate safety, tolerability and clinical effects of a rapid up-titration dosing regimen of subcutaneous treprostinil using proactive infusion site pain management. Methods: Effects of rapid up-titration dosing regimen on tolerability and clinical parameters were evaluated in this 16-week, open-label multi-centre study. Results: Thirty-nine patients with idiopathic or heritable pulmonary

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The Infection Risk of Intrathecal Drug Infusion Pumps after Multiple Refill Procedures

Cited by 26 publications

References 19 publications

Programmable Intrathecal Opioid Delivery Systems for Chronic Noncancer Pain: A Systematic Review of Effectiveness and Complications

Programmable Intrathecal Opioid Delivery Systems for Chronic Noncancer Pain: A Systematic Review of Effectiveness and Complications

Safety, Tolerability and Clinical Effects of a Rapid Dose Titration of Subcutaneous Treprostinil Therapy in Pulmonary Arterial Hypertension: A Prospective Multi-Centre Trial

Safety, tolerability and clinical effects of a rapid dose titration of subcutaneous treprostinil therapy in pulmonary arterial hypertension: a prospective multi-centre trial.

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