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Antibiotic Prophylaxis for Enteryx™ Procedure: Preliminary Results
Abstracts
S1110 Enhanced Killing of Biliary Bacterial Biofilm Using Electroporation: An In Vitro Evaluation Yanlei Liu, Joseph W. Leung
S1112 Blinded BIS Monitoring During ERCP Shows Additional Sedatives Are Often Given When Patients Are Already in Deep Sedation Kai Matthes, Jonathan Cohen, Louis Y. Lee, Marc J. Bloom
Background: Bacterial biofilm is a known cause of chronic device related infections requiring removal of implanted device such as a biliary stent. Biofilm bacteria are resistant to antibiotic therapy requiring 100 to 1000 times minimum inhibitory concentration (MIC) for complete eradication. Electroporation (EP) - a pulsed electrical field induces cell membrane permeability and enhances penetration of drugs into bacterial cells. Aim: To determine effects of EP and antibiotics therapy in eradication of biofilm bacteria. Method: Mixed biofilm were formed on micro TFA filters (Applied Biosystems, CA) by incubation with E. coli (E) and Enterococcus (En) in ox bile for 72 hours. The established biofilm was tested against Ciprofloxacin at 100xMIC for E. coli (Cipro) or 4% tetra sodium EDTA (TE) with or without EP. The filters were inserted into cuvettes and electroporated (ECM 630, Harvard Apparatus, MA) with constant voltage, capacitance, pulse duration, frequency and number of pulses for 1 minute. The experiments were divided into 2 groups with 10 or 15 EP pulses and exposure to individual antimicrobials for 4 hours. Experiments included: 1. Control; 2. 10 pulses of EP at 1500 volts; 3. 4% TE; 4. Cipro at 100xMIC; 5. EP plus Cipro; 6. EP plus TE. Experiments were repeated using 15 EP pulses. The filters were rinsed and then sonicated in 5 ml sterile PBS to release the bacteria. Bacterial counts in colony forming units (CFU/cm2) were determined by serial dilution and viable plate count method. The experiments were repeated and the mean bacterial count (n Z 2) was calculated and expressed as mean (log10 CFU/cm2) G SD. Results: Mean control bacterial counts were (E 5.65.8, En 4.8-4.4). Compared with controls, EP at 10 pulses or Cipro alone produced a 100-fold (2 log) reduction in E. coli but no significant effects on Enterococcus; 2. EP plus Cipro produced a 100-fold decrease in E. coli and 10-fold decrease in Enterococcus. 3. TE alone killed all E. coli but not Enterococcus; 4. EP plus 4% TE produced a 100-fold decrease in Enterococcus. With 15 EP pulses, all E. coli were killed by Cipro. A combination of TE and 15 EP pulses killed ALL bacteria in the biofilm. The differences were statistically significant (Box plot, p ! 0.001). Conclusion: Electroporation enhanced the killing effects of antibiotics/antimicrobials against established biofilm bacteria and may offer an alternative to prevent biliary biofilm and stent blockage.
Anesthesiologists are often asked to provide sedation for ERCP and their choice of medications for monitored anesthesia care (MAC) is largely operator dependent. When propofol is used, patients often cross into deep sedation, which has been shown to correspond to an average Bispectral Index monitoring (BIS) level of 70 (Bower AL et al. Gastrointest Endosc. 2000 Aug;52(2):192-6). The aim of our study was to compare BIS rates with vital signs and clinical assessment during ERCP in patients receiving MAC. Methods: After institutional IRB approval, 23 adults, ASA 1 to 3 were enrolled in the study. The BIS monitor was recorded throughout, but hidden from the anesthesiologist. Vital signs, patient’s clinical signs of consciousness, and the timing and doses of all drugs administered were recorded. Results: The mean heart rate, blood pressure and O2 saturation at the end of the procedure were not significantly different from the start values. However, the mean BIS score of 63 at the end of the procedure was significantly different from the mean of 95 at the start (p ! 0.0001), representing a deep level of sedation at the time of withdrawal of the endoscope. 16 patients received extra sedation during the procedure. In 3 of 7 patients (43%) in whom additional doses of fentanyl were given, the BIS score was below 60 at the time. Similar low BIS scores were present in 2 out of 6 patients (33%) in whom the propofol drip rate was increased and in 3 of 11 patients (27%) who received additional boluses of propofol. Eight of the 23 patients in the study (35%) received additional medication despite being already deeply sedated (BIS ! 60). None of these 8 patients had clinical signs of oversedation or a drop in O2 saturation to ! 90%, and only one of them had a decrease in blood pressure of more than 30% from the initial value. No cardiorespiratory complications occurred in this study. There was great heterogeneity to the drugs and doses and means of administration (bolus vs. drip) used for sedation. Conclusion: Vital signs and clinical signs do not correlate well with the patient’s level of sedation. Patients remain deeply sedated upon completion of ERCP making continuous clinical observation essential to assure patients’ safety. Knowledge about the BIS score would have been useful to provide additional information about the level of consciousness and presumably would have prevented additional amounts of sedatives been given to patients already at a deep level of sedation.
S1113 Efficacy and Acceptability of High Dose Senna Compared with Standard Polyethylene Glycol Solution for Colon Cleansing Prior To Colonoscopy: Preliminary Results of a Randomized, Investigator-Blind Trial Franco Radaelli, Gianmichele Meucci, Vittorio Terruzzi, Enrico Strocchi, Gianni Imperiali, Giancarlo Spinzi, Giorgio Minoli S1111 Antibiotic Prophylaxis for EnteryxÔ Procedure: Preliminary Results Michele Marchese, Roberto Cauda, Rita Citton, Andrea Tringali, Cristiano Spada, Evelina Tacconelli, Guido Costamagna Introduction: Gastroesophageal reflux disease (GERD) is one of the most common gastrointestinal disorder. EnteryxTM (Boston Scientific Corporation, Natick, Massachussets, USA) is a recently FDA-approved procedure for endoscopic treatment of GERD. About 12% of patients treated by EnteryxTM, experience fever of unknown origin within 24h post byopolimer implantation. No data are available about antibiotic prophylaxis in these patients. The aim of this preliminary study is to investigate the prevalence of bacteremia after Enteryx injection. Methods: A cohort study, including all consecutive patients, admitted at our institute to perform EnteryxTM injection, was started on June 2004. For each patients we collected age, sex, white blood cells count, risk factors for bloodstream infections, co-morbidity and previous antibiotic therapy. All patients underwent two bloodcultures after EnteryxTM procedure when they became febrile. No antibiotics prophylaxis were given. Results: Six patients (4 males and 2 females, 42.6 median age, range 26-55), with PPIs-dependent GERD symptoms were enrolled. At admission no patients had signs or symptoms of infection in any site and none received antibiotic prophylaxis. One patient had a history of Helicobacter pylori gastritis eradicated one year before the study. Five patients (83%) became febrile (body temperature O99.5 F) within 24 hours of EnteryxTM injection. All bloodcultures were negative and none had leucocytosis. After one month of follow-up no patients were no sign or symptoms of infection. Conclusions: These preliminary data show that the development of fever after EnteryxTM injection is probably associated to the procedure itself and not to bacteremia. Further results are needed to confirm that antibiotic prophylaxis is not necessary for this procedure.
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Objective: to compare the efficacy and acceptability of high dose senna to a polyethylene glycol (PEG) solution in adult patients. Methods: consecutive outpatients scheduled for elective colonoscopy were prospectively randomly assigned to receive one of the following study products: 24 (300 mg) senna tablets, taken in divided doses at 1.p.m. and 9 p.m. on the day before the procedure (Senna Group), or standard 4L PEG solution (PEG Group). The overall quality of colon cleansing (primary efficacy variable), as well as cleansing in the right colon, were rated on a 4-point validated scale (1, excellent to 4, inadequate) by the investigator/ endoscopist who was blinded to the treatment assignment. Patient acceptability of the preparation was assessed before the procedure by a nurse through a structured questionnaire concerning the compliance with the colon cleansing regimens, the overall tolerance of preparation (1, excellent to 5, very poor) and side effects (abdominal pain, nausea, vomiting, dizziness, headache). Results: 192 patients (48% males, mean age 56 yr) were evaluated. Main outcomes are reported in the table below:
Conclusions: Senna tablets is effective for colon cleansing and better tolerated when compared with high volume PEG solution.
Volume 61, No. 5 : 2005 GASTROINTESTINAL ENDOSCOPY AB119
S1110 Enhanced Killing of Biliary Bacterial Biofilm Using Electroporation: An In Vitro Evaluation Yanlei Liu, Joseph W. Leung
S1112 Blinded BIS Monitoring During ERCP Shows Additional Sedatives Are Often Given When Patients Are Already in Deep Sedation Kai Matthes, Jonathan Cohen, Louis Y. Lee, Marc J. Bloom
Background: Bacterial biofilm is a known cause of chronic device related infections requiring removal of implanted device such as a biliary stent. Biofilm bacteria are resistant to antibiotic therapy requiring 100 to 1000 times minimum inhibitory concentration (MIC) for complete eradication. Electroporation (EP) - a pulsed electrical field induces cell membrane permeability and enhances penetration of drugs into bacterial cells. Aim: To determine effects of EP and antibiotics therapy in eradication of biofilm bacteria. Method: Mixed biofilm were formed on micro TFA filters (Applied Biosystems, CA) by incubation with E. coli (E) and Enterococcus (En) in ox bile for 72 hours. The established biofilm was tested against Ciprofloxacin at 100xMIC for E. coli (Cipro) or 4% tetra sodium EDTA (TE) with or without EP. The filters were inserted into cuvettes and electroporated (ECM 630, Harvard Apparatus, MA) with constant voltage, capacitance, pulse duration, frequency and number of pulses for 1 minute. The experiments were divided into 2 groups with 10 or 15 EP pulses and exposure to individual antimicrobials for 4 hours. Experiments included: 1. Control; 2. 10 pulses of EP at 1500 volts; 3. 4% TE; 4. Cipro at 100xMIC; 5. EP plus Cipro; 6. EP plus TE. Experiments were repeated using 15 EP pulses. The filters were rinsed and then sonicated in 5 ml sterile PBS to release the bacteria. Bacterial counts in colony forming units (CFU/cm2) were determined by serial dilution and viable plate count method. The experiments were repeated and the mean bacterial count (n Z 2) was calculated and expressed as mean (log10 CFU/cm2) G SD. Results: Mean control bacterial counts were (E 5.65.8, En 4.8-4.4). Compared with controls, EP at 10 pulses or Cipro alone produced a 100-fold (2 log) reduction in E. coli but no significant effects on Enterococcus; 2. EP plus Cipro produced a 100-fold decrease in E. coli and 10-fold decrease in Enterococcus. 3. TE alone killed all E. coli but not Enterococcus; 4. EP plus 4% TE produced a 100-fold decrease in Enterococcus. With 15 EP pulses, all E. coli were killed by Cipro. A combination of TE and 15 EP pulses killed ALL bacteria in the biofilm. The differences were statistically significant (Box plot, p ! 0.001). Conclusion: Electroporation enhanced the killing effects of antibiotics/antimicrobials against established biofilm bacteria and may offer an alternative to prevent biliary biofilm and stent blockage.
Anesthesiologists are often asked to provide sedation for ERCP and their choice of medications for monitored anesthesia care (MAC) is largely operator dependent. When propofol is used, patients often cross into deep sedation, which has been shown to correspond to an average Bispectral Index monitoring (BIS) level of 70 (Bower AL et al. Gastrointest Endosc. 2000 Aug;52(2):192-6). The aim of our study was to compare BIS rates with vital signs and clinical assessment during ERCP in patients receiving MAC. Methods: After institutional IRB approval, 23 adults, ASA 1 to 3 were enrolled in the study. The BIS monitor was recorded throughout, but hidden from the anesthesiologist. Vital signs, patient’s clinical signs of consciousness, and the timing and doses of all drugs administered were recorded. Results: The mean heart rate, blood pressure and O2 saturation at the end of the procedure were not significantly different from the start values. However, the mean BIS score of 63 at the end of the procedure was significantly different from the mean of 95 at the start (p ! 0.0001), representing a deep level of sedation at the time of withdrawal of the endoscope. 16 patients received extra sedation during the procedure. In 3 of 7 patients (43%) in whom additional doses of fentanyl were given, the BIS score was below 60 at the time. Similar low BIS scores were present in 2 out of 6 patients (33%) in whom the propofol drip rate was increased and in 3 of 11 patients (27%) who received additional boluses of propofol. Eight of the 23 patients in the study (35%) received additional medication despite being already deeply sedated (BIS ! 60). None of these 8 patients had clinical signs of oversedation or a drop in O2 saturation to ! 90%, and only one of them had a decrease in blood pressure of more than 30% from the initial value. No cardiorespiratory complications occurred in this study. There was great heterogeneity to the drugs and doses and means of administration (bolus vs. drip) used for sedation. Conclusion: Vital signs and clinical signs do not correlate well with the patient’s level of sedation. Patients remain deeply sedated upon completion of ERCP making continuous clinical observation essential to assure patients’ safety. Knowledge about the BIS score would have been useful to provide additional information about the level of consciousness and presumably would have prevented additional amounts of sedatives been given to patients already at a deep level of sedation.
S1113 Efficacy and Acceptability of High Dose Senna Compared with Standard Polyethylene Glycol Solution for Colon Cleansing Prior To Colonoscopy: Preliminary Results of a Randomized, Investigator-Blind Trial Franco Radaelli, Gianmichele Meucci, Vittorio Terruzzi, Enrico Strocchi, Gianni Imperiali, Giancarlo Spinzi, Giorgio Minoli S1111 Antibiotic Prophylaxis for EnteryxÔ Procedure: Preliminary Results Michele Marchese, Roberto Cauda, Rita Citton, Andrea Tringali, Cristiano Spada, Evelina Tacconelli, Guido Costamagna Introduction: Gastroesophageal reflux disease (GERD) is one of the most common gastrointestinal disorder. EnteryxTM (Boston Scientific Corporation, Natick, Massachussets, USA) is a recently FDA-approved procedure for endoscopic treatment of GERD. About 12% of patients treated by EnteryxTM, experience fever of unknown origin within 24h post byopolimer implantation. No data are available about antibiotic prophylaxis in these patients. The aim of this preliminary study is to investigate the prevalence of bacteremia after Enteryx injection. Methods: A cohort study, including all consecutive patients, admitted at our institute to perform EnteryxTM injection, was started on June 2004. For each patients we collected age, sex, white blood cells count, risk factors for bloodstream infections, co-morbidity and previous antibiotic therapy. All patients underwent two bloodcultures after EnteryxTM procedure when they became febrile. No antibiotics prophylaxis were given. Results: Six patients (4 males and 2 females, 42.6 median age, range 26-55), with PPIs-dependent GERD symptoms were enrolled. At admission no patients had signs or symptoms of infection in any site and none received antibiotic prophylaxis. One patient had a history of Helicobacter pylori gastritis eradicated one year before the study. Five patients (83%) became febrile (body temperature O99.5 F) within 24 hours of EnteryxTM injection. All bloodcultures were negative and none had leucocytosis. After one month of follow-up no patients were no sign or symptoms of infection. Conclusions: These preliminary data show that the development of fever after EnteryxTM injection is probably associated to the procedure itself and not to bacteremia. Further results are needed to confirm that antibiotic prophylaxis is not necessary for this procedure.
www.mosby.com/gie
Objective: to compare the efficacy and acceptability of high dose senna to a polyethylene glycol (PEG) solution in adult patients. Methods: consecutive outpatients scheduled for elective colonoscopy were prospectively randomly assigned to receive one of the following study products: 24 (300 mg) senna tablets, taken in divided doses at 1.p.m. and 9 p.m. on the day before the procedure (Senna Group), or standard 4L PEG solution (PEG Group). The overall quality of colon cleansing (primary efficacy variable), as well as cleansing in the right colon, were rated on a 4-point validated scale (1, excellent to 4, inadequate) by the investigator/ endoscopist who was blinded to the treatment assignment. Patient acceptability of the preparation was assessed before the procedure by a nurse through a structured questionnaire concerning the compliance with the colon cleansing regimens, the overall tolerance of preparation (1, excellent to 5, very poor) and side effects (abdominal pain, nausea, vomiting, dizziness, headache). Results: 192 patients (48% males, mean age 56 yr) were evaluated. Main outcomes are reported in the table below:
Conclusions: Senna tablets is effective for colon cleansing and better tolerated when compared with high volume PEG solution.
Volume 61, No. 5 : 2005 GASTROINTESTINAL ENDOSCOPY AB119