Implantable Infusion Pump

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Regina Steringer-mascherbauer - One of the best experts on this subject based on the ideXlab platform.

  • Rapid Switch From Subcutaneous to Intravenous Treprostinil in Precapillary Pulmonary Hypertension by Pump Implantation.
    Journal of cardiovascular pharmacology, 2021
    Co-Authors: Regina Steringer-mascherbauer, Lummerstorfer Maria, Függer Reinhold, Sigmund Elisabeth, Huber Charlotte, Engleder Dagmar, Fröschl Uwe, Aichinger Josef
    Abstract:

    ABSTRACT Limited data are available on the transition from subcutaneous to intravenous prostacyclin in precapillary pulmonary hypertension. We performed a retrospective analysis of all patients who were switched from subcutaneous to intravenous treprostinil with an Implantable Infusion Pump. We included 85 consecutive, clinically stable patients (mean age 66 years and range 16-85), who had been treated with subcutaneous treprostinil for mean 9 months (range 1-78) before Pump implantation. An interdisciplinary expert panel defined standards for this procedure before the first implantation. As the first patient experienced a significant hypotensive episode indicating treprostinil overdose postoperatively, the time span to stop subcutaneous treprostinil was reduced to 60 minutes for all following patients. No events associated with the switch from subcutaneous to intravenous treprostinil were observed during postoperative hospital stay in 84 (98.8%) patients. Taking into account a likely depot effect of subcutaneous treprostinil patients can safely be switched to the intravenous route by the implantation of an Infusion Pump.

  • Intravenous Treprostinil Delivered by the Implantable Pump Lenus Pro®: A Innovative “Surgical” Approach to Management of PAH
    The Journal of Heart and Lung Transplantation, 2013
    Co-Authors: Regina Steringer-mascherbauer, Veronika Eder, Charlotte Huber, Susanne Wittrich, I. Marecek, Hans Joachim Nesser
    Abstract:

    Purpose Continuous application of parenteral prostanoids with external Pump systems is associated with frequent side effects such as Infusion site pain with subcutaneous (s.c.) and rare but possibly life-threatening catheter related infections with intravenous (i.v.) administration. Lenus Pro ® Implantable Infusion Pump was developed to overcome the drawbacks of s.c. administration. Methods and Materials Between September 2010 and October 2012 20 patients underwent implantation at our center. All patients had experienced significant clinical benefits with s.c. Treprostinil but reported serious site pain. All implantations were performed under general anesthesia. Preoperatively single-shot antibiotic prophylaxis was given. After a catheter was placed in the subclavian or cephalic vein, the Pump pocket was prepared in the abdominal wall. Lenus Pro® Pump was filled intraoperatively, placed in the Pump pocket and fixed to the fascia. A catheter was tunneled under the breast tissue and connected with the central venous access by means of a titan connector. No intraoperative complications occurred; postoperatively three patients developed mild seroma. During follow-up, no other complications were observed. More than 300 refill procedures have been performed without any complications. Control of the reflow volume at every refill procedure revealed accurate and constant flow rate of Lenus Pro ® in all patients. Results Parenteral prostanoids are a cornerstone in the treatment of PAH. I.v. Treprostinil administered by Lenus Pro® was safe and effective in our study population, during more than 330 patient-months of treatment there were no Pump or catheter related complications, especially no infections. No refill complications were observed. The absence of Infusion related side effects is associated with an increase in quality of life, filling intervals of 28 days ensure optimal patient management and compliance. Conclusions We consider this new treatment option a milestone achievement in prostanoid therapy and management of PA.

  • First long-term experience with intravenous treprostinil administered by the Implantable Infusion Pump LenusPro. A single-center pilot study
    European Respiratory Journal, 2012
    Co-Authors: Regina Steringer-mascherbauer, Veronika Eder, Charlotte Huber, Susanne Wittrich, Reinhold Fuegger, Uwe Fröschl, Hans Joachim Nesser
    Abstract:

    Introduction Parenteral prostanoids are considered to be the most potent agents in the treatment of pulmonary arterial hypertension (PAH). However, administration of prostanoids with external Pump systems is technically challenging and associated with side effects such as Infusion site pain with subcutaneous (s.c.) and possibly life-threatening catheter-related infections with intravenous (i.v.) administration. The Lenus Pro Implantable Infusion Pump was specifically developed to overcome the drawbacks of s.c. administration. In 2010, we reported the first implantation of a Lenus Pro Pump with a filling interval of 28 days. Results Between September 2010 and October 2011, 14 patients underwent implantation at our center. All patients had previously shown significant clinical response to s.c. Treprostinil but suffered from site pain. Implantations were performed under general anesthesia. After preparation of the Pump pocket in the abdominal wall the Pump was connected to the central venous access. No intraoperative complications occurred. Postoperatively two patients developed a mild seroma. No other complications especially no infections were observed. Up to now more than 100 refill procedures were performed. Conclusions This first pilot study demonstrates that i.v. Treprostinil, delivered by the Implantable Pump Lenus Pro® is safe, effective and feasible in PAH patients transitioned from s.c. Treprostinil. Filling intervals of 28 days ensure optimal compliance and long-term patient management. The absence of side effects such as Infusion site pain is associated with a dramatic increase in quality of life.

Hans Joachim Nesser - One of the best experts on this subject based on the ideXlab platform.

  • Intravenous Treprostinil Delivered by the Implantable Pump Lenus Pro®: A Innovative “Surgical” Approach to Management of PAH
    The Journal of Heart and Lung Transplantation, 2013
    Co-Authors: Regina Steringer-mascherbauer, Veronika Eder, Charlotte Huber, Susanne Wittrich, I. Marecek, Hans Joachim Nesser
    Abstract:

    Purpose Continuous application of parenteral prostanoids with external Pump systems is associated with frequent side effects such as Infusion site pain with subcutaneous (s.c.) and rare but possibly life-threatening catheter related infections with intravenous (i.v.) administration. Lenus Pro ® Implantable Infusion Pump was developed to overcome the drawbacks of s.c. administration. Methods and Materials Between September 2010 and October 2012 20 patients underwent implantation at our center. All patients had experienced significant clinical benefits with s.c. Treprostinil but reported serious site pain. All implantations were performed under general anesthesia. Preoperatively single-shot antibiotic prophylaxis was given. After a catheter was placed in the subclavian or cephalic vein, the Pump pocket was prepared in the abdominal wall. Lenus Pro® Pump was filled intraoperatively, placed in the Pump pocket and fixed to the fascia. A catheter was tunneled under the breast tissue and connected with the central venous access by means of a titan connector. No intraoperative complications occurred; postoperatively three patients developed mild seroma. During follow-up, no other complications were observed. More than 300 refill procedures have been performed without any complications. Control of the reflow volume at every refill procedure revealed accurate and constant flow rate of Lenus Pro ® in all patients. Results Parenteral prostanoids are a cornerstone in the treatment of PAH. I.v. Treprostinil administered by Lenus Pro® was safe and effective in our study population, during more than 330 patient-months of treatment there were no Pump or catheter related complications, especially no infections. No refill complications were observed. The absence of Infusion related side effects is associated with an increase in quality of life, filling intervals of 28 days ensure optimal patient management and compliance. Conclusions We consider this new treatment option a milestone achievement in prostanoid therapy and management of PA.

  • First long-term experience with intravenous treprostinil administered by the Implantable Infusion Pump LenusPro. A single-center pilot study
    European Respiratory Journal, 2012
    Co-Authors: Regina Steringer-mascherbauer, Veronika Eder, Charlotte Huber, Susanne Wittrich, Reinhold Fuegger, Uwe Fröschl, Hans Joachim Nesser
    Abstract:

    Introduction Parenteral prostanoids are considered to be the most potent agents in the treatment of pulmonary arterial hypertension (PAH). However, administration of prostanoids with external Pump systems is technically challenging and associated with side effects such as Infusion site pain with subcutaneous (s.c.) and possibly life-threatening catheter-related infections with intravenous (i.v.) administration. The Lenus Pro Implantable Infusion Pump was specifically developed to overcome the drawbacks of s.c. administration. In 2010, we reported the first implantation of a Lenus Pro Pump with a filling interval of 28 days. Results Between September 2010 and October 2011, 14 patients underwent implantation at our center. All patients had previously shown significant clinical response to s.c. Treprostinil but suffered from site pain. Implantations were performed under general anesthesia. After preparation of the Pump pocket in the abdominal wall the Pump was connected to the central venous access. No intraoperative complications occurred. Postoperatively two patients developed a mild seroma. No other complications especially no infections were observed. Up to now more than 100 refill procedures were performed. Conclusions This first pilot study demonstrates that i.v. Treprostinil, delivered by the Implantable Pump Lenus Pro® is safe, effective and feasible in PAH patients transitioned from s.c. Treprostinil. Filling intervals of 28 days ensure optimal compliance and long-term patient management. The absence of side effects such as Infusion site pain is associated with a dramatic increase in quality of life.

Manu M Sebastian - One of the best experts on this subject based on the ideXlab platform.

  • prolonged intracerebral convection enhanced delivery of topotecan with a subcutaneously Implantable Infusion Pump
    Neuro-oncology, 2011
    Co-Authors: Adam M Sonabend, Morgan R Stuart, Jonathan Yun, Ted K Yanagihara, Hamed Mohajed, Stephen Dashnaw, Samuel S Bruce, Truman R Brown, Alex Romanov, Manu M Sebastian
    Abstract:

    Intracerebral convection-enhanced delivery (CED) of chemotherapeuticagentscurrentlyrequiresanexternalizedcatheterand Infusion system, which limits its duration because of the need for hospitalization and the risk of infection. To evaluate the feasibility of prolonged topotecan administration by CED in a large animal brain with the use of a subcutaneous Implantable Pump. Medtronic Synchromed-II Pumps were implanted subcutaneously for intracerebral CED in pigs. Gadodiamide (28.7 mg/mL), with or without topotecan (136 mM), was infused at 0.7 mL/24 h for 3 or 10 days. Pigs underwent magnetic resonance imaging before and at 6 times points after surgery. Enhancement and FLAIR1 volumes were calculated in a semi-automated fashion. Magnetic resonance spectroscopy-based topotecan signaturewasalsoinvestigated.Brainhistologywasanalyzed

  • Prolonged intracerebral convection-enhanced delivery of topotecan with a subcutaneously Implantable Infusion Pump.
    Neuro-oncology, 2011
    Co-Authors: Adam M Sonabend, Jonathan Yun, Ted K Yanagihara, Hamed Mohajed, Stephen Dashnaw, Samuel S Bruce, Truman R Brown, Alex Romanov, R. Morgan Stuart, Manu M Sebastian
    Abstract:

    Intracerebral convection-enhanced delivery (CED) of chemotherapeutic agents currently requires an externalized catheter and Infusion system, which limits its duration because of the need for hospitalization and the risk of infection. To evaluate the feasibility of prolonged topotecan administration by CED in a large animal brain with the use of a subcutaneous Implantable Pump. Medtronic Synchromed-II Pumps were implanted subcutaneously for intracerebral CED in pigs. Gadodiamide (28.7 mg/mL), with or without topotecan (136 μM), was infused at 0.7 mL/24 h for 3 or 10 days. Pigs underwent magnetic resonance imaging before and at 6 times points after surgery. Enhancement and FLAIR+ volumes were calculated in a semi-automated fashion. Magnetic resonance spectroscopy-based topotecan signature was also investigated. Brain histology was analyzed by hematoxylin and eosin staining and with immunoperoxidase for a microglial antigen. CED of topotecan/gadolinium was well tolerated in all cases (n = 6). Maximum enhancement volume was reached at day 3 and remained stable if CED was continued for 10 days, but it decreased if CED was stopped at day 3. Magnetic resonance spectroscopy revealed a decrease in parenchymal metabolites in the presence of topotecan. Similarly, the combination of topotecan and gadolinium Infusion led to a FLAIR+ volume that tended to be larger than that seen after the Infusion of gadolinium alone. Histological analysis of the brains showed an area of macrophage infiltrate in the ipsilateral white matter upon Infusion with topotecan/gadolinium. Intracerebral topotecan CED is well tolerated in a large animal brain for up to 10 days. Intracerebral long-term CED can be achieved with a subcutaneously implanted Pump and provides a stable volume of distribution. This work constitutes a proof of principle for the safety and feasibility for prolonged CED, providing a means of continuous local drug delivery that is accessible to the practicing neuro-oncologist.

Susan C. Harvey - One of the best experts on this subject based on the ideXlab platform.

  • Stability of meperidine in an Implantable Infusion Pump using capillary gas chromatography-mass spectrometry and a deuterated internal standard.
    Journal of pharmaceutical and biomedical analysis, 1999
    Co-Authors: Susan C. Harvey, Michael G. O’neil, Charles P Toussaint, Sharon E Coe, Erin E Watson, Kennerly S. Patrick
    Abstract:

    Abstract A capillary gas chromatographic–mass spectrometric (GC–MS) method is described for the analysis of meperidine using 3,3,5,5-[ 2 H 4 ]-meperidine as an internal standard. Chromatography was performed on a (5% phenyl)methylpolysiloxane column (30 m×0.32 mm I.D., 0.25 μm film thickness) operated at 195°C; helium carrier gas-50 cm s −1 , t R =2.3 min. Ionization was by electron impact (EI) and detection by selected ion monitoring of the molecular ions. The method provided high response linearity (mean r =0.9982) and precision ( −1 ) stability in a surgically Implantable Infusion Pump at 37°C for 90 days revealed no demonstrable drug degradation.

  • Continuous Intrathecal Meperidine via an Implantable Infusion Pump for Chronic, Nonmalignant Pain
    The Annals of pharmacotherapy, 1997
    Co-Authors: Susan C. Harvey, Michael G. O’neil, Catherine A Pope, Brian G. Cuddy, Thomas A Duc
    Abstract:

    OBJECTIVE:To report a continuous Infusion of intrathecal meperidine via an implanted Infusion Pump for nonmalignant, chronic pain.CASE SUMMARY:A 69-year-old white woman had chronic, nonmalignant low-back pain and bilateral leg pain. Multiple drug therapies and other interventional techniques had failed. The patient achieved significant pain relief by a continuous Infusion of intrathecal meperidine via an implanted Infusion Pump.DISCUSSION:To our knowledge, this is the first report of meperidine administered intrathecally by continuous Infusion. Continuous Infusion of intrathecal and epidural opiates by implanted Infusion Pumps is becoming more widely recognized as an alternative treatment for patients with chronic, benign pain. Epidural and intrathecal meperidine is an effective analgesic for short-term surgical procedures. Data reporting effective relief and safety with continuous intrathecal meperidine remain limited.CONCLUSIONS:Continuous intrathecal meperidine via an Implantable Infusion Pump may be a...

Pieter Van Remoortere - One of the best experts on this subject based on the ideXlab platform.

  • Development of an Implantable Infusion Pump for sustained anti-HIV drug administration.
    International journal of pharmaceutics, 2008
    Co-Authors: Lieven Baert, Laurent Schueller, Yanik Tardy, Doug Macbride, Gerben Van't Klooster, Herman Borghys, Ellen Clessens, Guy Van Den Mooter, Elke Van Gyseghem, Pieter Van Remoortere
    Abstract:

    Factors such as insufficient drug potency, non-compliance and restricted tissue penetration contribute to incomplete suppression of Human Immunodeficiency Virus (HIV) and the difficulty to control this infection. Infusion via standard catheters can be a source of infection, which is potentially life threatening in these patients. We developed an Implantable Infusion Pump, allowing to accommodate large volumes (16-50mL) of high viscous solutions (up to 23.96mPas at 39 degrees C) of anti-HIV agents and providing sustained release of medication: a standard Codman 3000 Pump, which was initially developed to release aqueous solutions ( approximately 0.7mPas) into the spinal cord such as for pain medication, was transformed for release of viscous solutions up to 40mPas by adapting the diameter of the capillary flow restrictor, the capillary length and way of catheterisation--by placing the indwelling catheter in the vena cava. A pilot study of the Pump implanted in 2 dogs showed continuous steady-state release of the protease inhibitor darunavir (25mg/dog/day administered for 25 days), thereby achieving plasma concentration levels of approximately 40ng/mL. Steady-state plasma levels were reproducible after monthly refill of the Pumps. In conclusion, the Implantable adapted Codman 3000 constant-flow Infusion Pump customized to anti-HIV therapy allows sustained release of anti-HIV medication and may represent an opportunity to reduce the pill burden and complexity of dosing schemes associated with common anti-HIV therapy.

  • Development of an Implantable Infusion Pump for sustained anti-HIV drug administration.
    International Journal of Pharmaceutics, 2008
    Co-Authors: Baert Lieven Elvire Colette, Laurent Schueller, Yanik Tardy, Doug Macbride, Herman Borghys, Ellen Clessens, Guy Van Den Mooter, Elke Van Gyseghem, Gerben Albert Eleutherius Van 't Klooster, Pieter Van Remoortere
    Abstract:

    Abstract Factors such as insufficient drug potency, non-compliance and restricted tissue penetration contribute to incomplete suppression of Human Immunodeficiency Virus (HIV) and the difficulty to control this infection. Infusion via standard catheters can be a source of infection, which is potentially life threatening in these patients. We developed an Implantable Infusion Pump, allowing to accommodate large volumes (16–50 mL) of high viscous solutions (up to 23.96 mPa s at 39 °C) of anti-HIV agents and providing sustained release of medication: a standard Codman ® 3000 Pump, which was initially developed to release aqueous solutions (∼0.7 mPa s) into the spinal cord such as for pain medication, was transformed for release of viscous solutions up to 40 mPa s by adapting the diameter of the capillary flow restrictor, the capillary length and way of catheterisation—by placing the indwelling catheter in the vena cava. A pilot study of the Pump implanted in 2 dogs showed continuous steady-state release of the protease inhibitor darunavir (25 mg/dog/day administered for 25 days), thereby achieving plasma concentration levels of ∼40 ng/mL. Steady-state plasma levels were reproducible after monthly refill of the Pumps. In conclusion, the Implantable adapted Codman ® 3000 constant-flow Infusion Pump customized to anti-HIV therapy allows sustained release of anti-HIV medication and may represent an opportunity to reduce the pill burden and complexity of dosing schemes associated with common anti-HIV therapy.