The Experts below are selected from a list of 264 Experts worldwide ranked by ideXlab platform
Robert J. Stagg - One of the best experts on this subject based on the ideXlab platform.
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Hepatic intra-arterial methylene blue injection during endoscopy: a method of detecting gastroduodenal misperfusion in patients receiving hepatic intra-arterial chemotherapy via an implanted Pump.
Gastrointestinal endoscopy, 1992Co-Authors: John W. Frye, Alan P. Venook, James W. Ostroff, Sean J. Mulvihill, Robert S. Warren, Carlos A. Pellegrini, Ernest J. Ring, Robert J. StaggAbstract:Colorectal cancer is the third most common malignancy in the United States, with about 150,000 newly diagnosed cases per year.1 About half of all patients ultimately develop liver metastases and in 50% of those liver involvement is the dominant clinical problem.2,~ Resection of hepatic metastases is only feasible in about 10% of patients and systemic chemotherapy produces responses in 15 to 35% of patients. Hepatic intra-arterial (HIA) chemotherapy has been used to treat patients with metastatic colorectal carcinoma confined to the liver since the early 1960s.s The theoretical advantage of this route of drug delivery is its ability to enhance anti-tumor effect by increasing drug exposure at the tumor site and to minimize toxicity by decreasing systemic drug exposure. The availability of the totally Implantable Pump in the early 1980s greatly facilitated prolonged outpatient administration of HIA chemotherapy. Numerous phase II and III trials have documented the activity of this therapy.9-19 In order to safely and effectively deliver HIA chemotherapy, complete hepatic perfusion and the absence of gastrointestinal misperfusion must be achieved. This requires both proper catheter placement and surgical division of all vessels that supply the distal stomach and duodenum which arise from the hepatic artery distal to the point of cannulation.20 Intra-operatively, fluorescein injection into the Pump sidepores with inspection of the liver and gastroduodenum using a Wood's lamp is done to assure proper catheter placement. A post-operative, hepatic perfusion study (comparing an intra-arterial technetium-99m macroaggregated albumin scan to an intravenous technetium-99m sulfur colloid scan)20 has been routinely used to further verify the perfusion pattern. Hepatic artery infusion computerized tomography can also be
J. P. Riveline - One of the best experts on this subject based on the ideXlab platform.
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Subcutaneous insulin resistance successfully circumvented on long term by peritoneal insulin delivery from an Implantable Pump in four diabetic patients.
Diabetes and Metabolism, 2005Co-Authors: J. P. Riveline, M. C. Vantyghem, C. Fermon, C. Brunet, J. F. Gautier, E. Renard, G. CharpentierAbstract:Extreme subcutaneous insulin resistance is a rare syndrome characterized by a severe resistance to subcutaneous (S/C) insulin together with persistence of normal or near normal intravenous (IV) insulin sensitivity. Its pathophysiology is unknown, although increased insulin degrading activity has been reported in the S/C adipose tissue fraction in some cases. Until now, proposed treatments have been disappointing. We report 4 cases who were successfully treated by intraperitoneal (IP) route. METHODS: The diagnosis of subcutaneous insulin resistance was based upon following combined conditions: resistance to hypoglycaemic action of subcutaneous insulin but normal or near normal sensitivity to IV or IP insulin. RESULTS: 4 patients among those followed by EVADIAC group met these criteria: 3 with type 1 diabetes (C peptide=0), the last one with unexplained non insulin-deficient diabetes (no anti-GAD antibodies, C peptide=5 ng/ml). All of them had been treated with subcutaneous insulin therapy without success despite huge doses (up to 4000 IU/day in two patients). The 3 type 1 diabetic patients presented with a history of repeated ketoacidosis episodes. A treatment of insulin mixed with aprotinin had been proposed to 2 patients without success. The IV insulin sensitivity was proved to be normal in two patients by euglycaemic clamp data. A skin biopsy was performed in 1 patient. An accumulation of insulin in the derma was revealed with no increase of degradation products of insulin. In these 4 patients, a dramatic improvement of diabetes control was obtained by IP insulin delivery from an Implantable Pump (HbA1c decrease by at least 3%). CONCLUSION: Although pathophysiology of the subcutaneous insulin resistance syndrome remains unexplained, our data show that intra-peritoneal insulin therapy from an Implantable Pump allows diabetes control in patients affected by this uncommon but severely disabling condition.
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Combined improvements in Implantable Pump technology and insulin stability allow safe and effective long term intraperitoneal insulin delivery in type 1 diabetic patients: the EVADIAC experience.
Diabetes & metabolism, 2003Co-Authors: H Gin, J. P. Riveline, S Boivin, Eric Renard, J. L. Selam, Bruno Guerci, V. Melki, P. Schaepelynck‐bélicar, Jm Brun, B EstourAbstract:Summary Objective To report a long-term multicentre experience with Implantable insulin Pumps in type 1 diabetic patients, and to test safety and accuracy of the systems following improvements in infused insulin solutions and peritoneal catheter. Research design and methods Forty MiniMed Implantable Pumps model 2001 were consecutively implanted over a two-month period in type 1 diabetic volunteers. The systems were equipped by a new compliant sideport catheter and were refilled at 45-day intervals with HOE 21 PH ETP insulin batches showing enhanced physical stability in vitro . Safety was assessed from the incidence of acute adverse events and effectiveness from quarterly HbA 1c assays. Accuracy of delivery was measured at each Pump refill by comparing residual insulin in the Pump reservoir with expected amount according to programmed infusion. The study lasted until Pump battery depletion or premature Pump explantation. Results Cumulated experience was 106 patient-years. Premature explantations occurred in 3 cases, due to one electronic Pump failure and two "Pump-pocket" infections. Near-normal insulin delivery was sustained until expected battery depletion in 13 cases. Forty underdelivery events occurred in 24 Pumps, but 36 among them were related to Pump slowdowns due to insulin aggregation in Pumps that were promply solved by an outpatient NaOH rinse procedure. Only 4 underdeliveries were caused by catheter obstructions that required laparoscopy to remove peritoneal tissue overgrowth around the catheter. Over Pump lifetime, HbA 1c was 7.2 ± 0.2% in the 13 patients with no underdelivery and 7.7 ± 0.5% in the other ones. Only one severe hypoglycemia and one ketoacidosis occurred during the whole study. Conclusion Our current experience with improved Implantable Pumps and insulin solutions shows both long-term safety and effectiveness of this treatment in type 1 diabetic patients following improvement in infused insulin solutions and catheter. This therapy may be a good alternative for patients that experience frequent severe hypoglycemia with intensive subcutaneous insulin therapy.
Manuel J. Richter - One of the best experts on this subject based on the ideXlab platform.
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flow rate variance of a fully Implantable Pump for the delivery of intravenous treprostinil in pulmonary arterial hypertension
Pulmonary circulation, 2020Co-Authors: Manuel J. Richter, Henning Gall, Simon Classen, Hossein Ardeschir Ghofrani, Satenik Harutyunova, Tom Bollmann, Jan Fuge, Felix Gerhardt, Hartmut Gunkel, Ekkehard GrunigAbstract: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. ...
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flow rate variance of a fully Implantable Pump for the delivery of intravenous treprostinil in pulmonary arterial hypertension
Pulmonary circulation, 2020Co-Authors: Manuel J. Richter, Henning Gall, Simon Classen, Hossein Ardeschir Ghofrani, Satenik Harutyunova, Tom Bollmann, Jan Fuge, Felix Gerhardt, Hartmut Gunkel, Ekkehard GrunigAbstract: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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Intravenous treprostinil via an Implantable Pump in pediatric pulmonary arterial hypertension.
Pulmonary circulation, 2018Co-Authors: Susanna Desole, Manuel J. Richter, Alexander Heine, Ralf EwertAbstract:Intravenous prostacyclin-based therapy improves survival in children with pulmonary arterial hypertension (PAH), but is typically administered via an external infusion Pump, which places a considerable burden on the patient. Implanted Pumps may overcome some of the limitations of external Pumps. We describe the first long-term use of an implanted Pump for intravenous treprostinil delivery in a pediatric patient with PAH. Our patient was experiencing marked dyspnea on exertion despite triple combination therapy with bosentan, sildenafil, and inhaled iloprost. Parenteral prostacyclin-based therapy was discussed and the patient rejected options involving external Pumps; she finally chose intravenous treprostinil delivery via an implanted Pump (LENUS Pro®; fixed flow rate; 20 ml reservoir). The patient underwent Pump implantation in July 2012 (aged 14 years) under general anesthesia with no peri- or postoperative complications. She showed marked improvements in fatigue and dyspnea over the subsequent weeks, and her inhaled iloprost regimen was slowly decreased and stopped after six months. During follow-up, the Pump showed an unexpected, progressive increase in flow rate that allowed a treprostinil dose of 170 ng/kg/min to be achieved, but at the cost of shortened intervals between refills. The Pump was therefore replaced in August 2017 with a newer model with an adjustable flow rate (Siromedes®). A catheter dislocation was corrected under local anesthesia one week after the replacement surgery. The patient is currently receiving treprostinil 170 ng/kg/min with percutaneous refills every 12-13 days. Thus, Implantable Pumps might be a valuable alternative to external Pumps for treprostinil infusion in pediatric PAH.
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Long-term safety and outcome of intravenous treprostinil via an implanted Pump in pulmonary hypertension.
The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation, 2018Co-Authors: Manuel J. Richter, Henning Gall, Simon Classen, Friedrich Grimminger, Ekkehard Grunig, Satenik Harutyunova, Tom Bollmann, Felix Gerhardt, Jan Grimminger, Stefan GuthAbstract:BACKGROUND We examined safety and long-term outcomes of intravenous treprostinil administered via the Implantable LENUS Pro Pump in patients with severe pulmonary hypertension (PH). METHODS Patients with PH undergoing Pump implantation between December 2009 and October 2016 in German referral centers were retrospectively analyzed (end of follow-up: May 2017). The primary objective was to determine long-term safety of the Implantable Pump. Secondary end points were 3-year survival and prognostic relevance of pre-implantation hemodynamics. RESULTS We monitored 129 patients (120 with pulmonary arterial hypertension, 1 with PH due to lung diseases, and 8 with inoperable chronic thromboembolic PH) for 260 patient-years (median follow-up, 19 months; interquartile range, 11–34 months). There were 82 complications/peri-procedural events in 60 patients; of these, 57 were serious adverse events (0.60 per 1,000 treatment-days), including 2 periprocedural deaths due to right heart failure. The incidence of complications related to the Pump, catheter, infection, and Pump pocket per 1,000 treatment-days was 0.074, 0.264, 0.032 (3 local infections; no bloodstream infections), and 0.380, respectively. Three-year overall and transplant-free survival were 66.5% and 55.7%, respectively (39 patients died; 16 underwent lung transplantation). Baseline cardiac index independently predicted transplant-free survival (multivariate hazard ratio, 1.90; 95% confidence interval, 1.11–3.28; p = 0.019; n = 95). CONCLUSIONS Our data suggest that intravenous treprostinil via the LENUS Pro Pump in advanced PH is associated with a very low risk of bloodstream infections, but other serious adverse events may occur. Therefore, this therapy needs standardization and should be offered in specialized PH centers only. Further technical advances of the Pump system and prospective studies are needed.
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Intravenous treprostinil infusion via a fully Implantable Pump for pulmonary arterial hypertension
Clinical Research in Cardiology, 2017Co-Authors: Ralf Ewert, Manuel J. Richter, Christian Warnke, Ekkehard Grunig, Tobias J Lange, Christian F Opitz, Regina Steringer-mascherbauer, Hossein Ardeschir GhofraniAbstract:Objectives Parenteral prostanoids infused via external Pumps are well-established pulmonary arterial hypertension (PAH) treatments. However, local side-effects and systemic infections restrict their use. The purpose of this study was to investigate the safety of a fully Implantable treprostinil infusion Pump (LENUS Pro^®) in patients with PAH. Methods Thirty patients with PAH undergoing Pump implantation (with stable PAH therapy for ≥3 weeks pre-implantation) were included in this prospective, multicenter, observational study (NCT01979822). Primary endpoints were predefined adverse events (AEs) during implantation, in-hospital and/or during 6-month follow-up. Refill-related AEs were a secondary endpoint. Results Twenty-nine patients completed 6-month follow-up (one underwent lung transplantation). During implantation, one pneumothorax (not requiring drainage) occurred. Four patients had an in-hospital AE (including one catheter revision). During 6-month follow-up, AEs were most frequent at the first refill (10); the most common AE was seroma around the Pump. No infections occurred. One Pump required replacement because of a defective septum caused by use of a non-approved refill needle (associated with extravasation). Apart from the extravasation, no refill-related AEs were recorded. Post hoc efficacy analyses showed significant improvements in functional class [number in functional class I/II/III/IV: 0/5/21/2 (baseline) versus 3/8/17/0 (6 months); p = 0.012] and 6-min walk distance (mean ± standard deviation: 407 ± 122 m versus 445 ± 127 m; n = 17; p = 0.014). Conclusions 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.
John W. Frye - One of the best experts on this subject based on the ideXlab platform.
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Hepatic intra-arterial methylene blue injection during endoscopy: a method of detecting gastroduodenal misperfusion in patients receiving hepatic intra-arterial chemotherapy via an implanted Pump.
Gastrointestinal endoscopy, 1992Co-Authors: John W. Frye, Alan P. Venook, James W. Ostroff, Sean J. Mulvihill, Robert S. Warren, Carlos A. Pellegrini, Ernest J. Ring, Robert J. StaggAbstract:Colorectal cancer is the third most common malignancy in the United States, with about 150,000 newly diagnosed cases per year.1 About half of all patients ultimately develop liver metastases and in 50% of those liver involvement is the dominant clinical problem.2,~ Resection of hepatic metastases is only feasible in about 10% of patients and systemic chemotherapy produces responses in 15 to 35% of patients. Hepatic intra-arterial (HIA) chemotherapy has been used to treat patients with metastatic colorectal carcinoma confined to the liver since the early 1960s.s The theoretical advantage of this route of drug delivery is its ability to enhance anti-tumor effect by increasing drug exposure at the tumor site and to minimize toxicity by decreasing systemic drug exposure. The availability of the totally Implantable Pump in the early 1980s greatly facilitated prolonged outpatient administration of HIA chemotherapy. Numerous phase II and III trials have documented the activity of this therapy.9-19 In order to safely and effectively deliver HIA chemotherapy, complete hepatic perfusion and the absence of gastrointestinal misperfusion must be achieved. This requires both proper catheter placement and surgical division of all vessels that supply the distal stomach and duodenum which arise from the hepatic artery distal to the point of cannulation.20 Intra-operatively, fluorescein injection into the Pump sidepores with inspection of the liver and gastroduodenum using a Wood's lamp is done to assure proper catheter placement. A post-operative, hepatic perfusion study (comparing an intra-arterial technetium-99m macroaggregated albumin scan to an intravenous technetium-99m sulfur colloid scan)20 has been routinely used to further verify the perfusion pattern. Hepatic artery infusion computerized tomography can also be
Michael Vloeberghs - One of the best experts on this subject based on the ideXlab platform.
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Status dystonicus resembling the intrathecal baclofen withdrawal syndrome: a case report and review of the literature
Journal of Medical Case Reports, 2010Co-Authors: William Muirhead, Ibrahim Jalloh, Michael VloeberghsAbstract:Introduction Status dystonicus is a rare but life-threatening disorder characterized by increasingly frequent and severe episodes of generalized dystonia that may occur in patients with primary or secondary dystonia. Painful and repetitive spasms interfere with respiration and may cause metabolic disturbances such as hyperpyrexia, dehydration, respiratory insufficiency, and acute renal failure secondary to rhabdomyolysis. Intrathecally administered baclofen, delivered by an Implantable Pump system, is widely used for the treatment of refractory spasticity. Abrupt cessation of intrathecal baclofen infusion has been associated with a severe withdrawal syndrome comprised of dystonia, autonomic dysfunction, hyperthermia, end-organ failure and sometimes death. The aetiology of this syndrome is not well understood. Status dystonicus describes the episodes of acute and life-threatening generalized dystonia, which occasionally manifest themselves in patients with dystonic syndromes. Case presentation We present the case of a nine-year-old Caucasian boy who experienced a severe episode of status dystonicus with no known cause and clinical features resembling those described in intrathecal baclofen withdrawal. Our patient subsequently underwent the placement of an intrathecal baclofen Pump without incident. Conclusion The similarity between the clinical features of the case we present and those reported in connection to abrupt withdrawal of intrathecal baclofen is emphasized. Several drugs, although not intrathecal baclofen withdrawal, have previously been associated with status dystonicus. The similarity between the life-threatening dystonic episode experienced by our patient, and those reported in intrathecal baclofen withdrawal, highlights the possibility that, rather than representing a true physiological withdrawal syndrome, abrupt withdrawal of intrathecal baclofen may simply precipitate an episode of status dystonicus in susceptible individuals. The clinical similarities between the intrathecal baclofen withdrawal syndrome and status dystonicus have not previously been highlighted.
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status dystonicus resembling the intrathecal baclofen withdrawal syndrome a case report and review of the literature
Journal of Medical Case Reports, 2010Co-Authors: William Muirhead, Ibrahim Jalloh, Michael VloeberghsAbstract:Introduction Status dystonicus is a rare but life-threatening disorder characterized by increasingly frequent and severe episodes of generalized dystonia that may occur in patients with primary or secondary dystonia. Painful and repetitive spasms interfere with respiration and may cause metabolic disturbances such as hyperpyrexia, dehydration, respiratory insufficiency, and acute renal failure secondary to rhabdomyolysis. Intrathecally administered baclofen, delivered by an Implantable Pump system, is widely used for the treatment of refractory spasticity. Abrupt cessation of intrathecal baclofen infusion has been associated with a severe withdrawal syndrome comprised of dystonia, autonomic dysfunction, hyperthermia, end-organ failure and sometimes death. The aetiology of this syndrome is not well understood. Status dystonicus describes the episodes of acute and life-threatening generalized dystonia, which occasionally manifest themselves in patients with dystonic syndromes.
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a clinical study of intrathecal baclofen using a programmable Pump for intractable spasticity
Archives of Physical Medicine and Rehabilitation, 2005Co-Authors: Daniel Guillaume, Michael Vloeberghs, Anthony Van Havenbergh, Joan Vidal, Geir RoesteAbstract:Abstract Guillaume D, Van Havenbergh A, Vloeberghs M, Vidal J, Roeste G. A clinical study of intrathecal baclofen using a programmable Pump for intractable spasticity. Objective To determine the impact of intrathecal baclofen (ITB) therapy on outcomes of functional independence, pain, subjective improvement, performance, and standard measures of spasticity. Design A noncomparative, multicenter, prospective cohort trial of patients with implanted Pumps followed up over a 12-month period for the assessment of spasticity, pain, and function. Setting Twenty-four European centers of neurology or rehabilitation familiar with Implantable Pump technique participated. Participants Patients with intractable spasticity (N=138) who responded positively to a trial dose of baclofen (n=133) and who began ITB therapy (n=129) were enrolled. Intervention Implantation of a Medtronic SynchroMed Infusion System with the administration of ITB therapy. Main Outcome Measures Ashworth Scale assessment, Penn Spasm Frequency Scale scores, pain assessment, FIM instrument scores or WeeFIM scores for children, Canadian Occupational Performance Measure (COPM), and subjective ratings of overall relief were the tools administered. Results Muscle tone, spasm scores, and pain intensity reductions were observed. Overall FIM scores increased significantly in cognitive and motor function. COPM scores for both performance and satisfaction also improved significantly. Patients reported increased relief from pain and spasticity, supported by physician reports. Forty-three percent of patients reported adverse events, mostly related to patients' underlying conditions (20%), the device implant surgery (10%), or complications with the catheter (9%). Conclusions ITB therapy using a programmable Pump is clinically effective and well tolerated, despite a seemingly high level of adverse events, in patients with intractable spasticity of spinal or cerebral origin and may offer improvements in pain relief and function.
