Int J Colorectal Dis DOI 10.1007/s00384-015-2212-z
LETTER TO THE EDITOR
Hemospray rescue treatment of severe refractory bleeding associated with ischemic colitis: a case series Antonino Granata 1 & Gabriele Curcio 1 & Luca Barresi 1 & Dario Ligresti 1 & Ilaria Tarantino 1 & Rosalba Orlando 1 & Mario Traina 1
Accepted: 11 April 2015 # Springer-Verlag Berlin Heidelberg 2015
Dear Editor: Ischemic colitis is a vascular condition of inadequate blood flow in the colon, which leads to colonic inflammation and mucosal damage with ulcerations; it is associated with significant morbidity and mortality. Multiple anecdotal case reports and case series have described associations of ischemic colitis with vascular surgery and vascular thromboembolism. Bleeding associated with nausea, vomiting, diarrhea, concomitant ischemic stroke, and ileus is quite common. Flexible sigmoidoscopy or complete colonoscopy is crucial for obtaining a histologic diagnosis, determining the severity of the IC, and treating the source of bleeding. Frequently used treatment modalities are injections, mechanical and thermal. However, these modalities may be not suitable in the case of tangentially located bleeding sites and diffusely bleeding lesions or when massive hemorrhage obscures the endoscopic view. Furthermore, thermo-coagulation, when suitable due to its in-depth application, can result in adverse events. Hemospray is an easily applicable hemostatic powder that has been shown to be effective in both focused and diffusely active bleeding lesions of the gastrointestinal tract. Evidence of its efficacy in the lower gastrointestinal bleeding (LGIB) is very limited, based on extrapolations of what happens in upper gastrointestinal bleeding, and on small series of patients. In Europe, Hemospray is not licensed for use in the lower gastrointestinal tract, so its use in this area is currently off-
* Antonino Granata [email protected] 1
Endoscopy Service, Department of Diagnostic and Therapeutic Services, IRCCS - ISMETT (Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione), Via Tricomi 5, 90127 Palermo, Italy
label. To date, its use in the lower gastrointestinal tract is licensed only in Canada. We present our experience with Hemospray rescue treatment of four cases of life-threatening IC-related LGIB after failure of conventional endoscopic techniques. From April, 2013, to August, 2014, all patients who underwent Hemospray treatment for IC-related LGIB were retrospectively analyzed. Endoscopic hemostatic interventions were performed exclusively by interventional endoscopists experienced in therapeutic colonoscopy and specifically trained in Hemospray application. Training consisted of 1 day of hands-on training on an ex vivo model. Each procedure was performed using a high-definition colonoscope (CF-H190L—Olympus Europa SE & CO. KG, Hamburg, Germany). A diagnosis of IC was histologically obtained with biopsies in all patients. After failure of conventional hemostatic techniques, Hemospray was deployed onto the active bleeding site through dedicated catheters and propelled by short bursts of carbon dioxide until complete hemostasis was achieved. Success was defined as persistent hemostasis after 3–5 min of visual inspection following Hemospray application. Immediately after each Hemospray application, CO2 was carefully suctioned to reduce bowel wall thinning and its potentially associated risk of perforation, even if it should be noted that suctioning during Hemospray treatment can lead to scope channel obstruction. The use of both catheters included in the box was necessary to complete Hemospray treatment for each procedure, due to catheter kinking or obstruction during application. In one case, in order to proceed with the treatment, an additional standard biliary Luer-lock 10 Fr catheter (FS-OA-10 Cook Medical, Winston-Salem, NC) was used. A total of four intensive care unit patients (three men; median age 50, range 22–66), with severe hypotension,
Int J Colorectal Dis
underwent Hemospray rescue treatment of active LGIB ulcer secondary to IC, after failure of conventional techniques. All patients were on antithrombotic therapy at the time of bleeding (acetyl salicylic acid, n=2; low molecular weight heparin, n=2). One of the patients was under extra-corporeal membrane oxygenation (ECMO) treatment requiring continuous heparin infusion. Clinical presentations consisted of profuse hematochezia and hypovolemic shock requiring blood transfusion and maximal medical support in all patients. Concerning the source of bleeding, endoscopy showed an oozing bleeding ulcer localized in one cecum, one ascending colon, one splenic flexure, and one descending colon; the mean ulcer diameter was 32 mm (range 25–50). At the time of emergency endoscopy, following unsuccessful hemostasis with hemoclip placement and epinephrine injection, and in consideration of the associated risks of thermal therapy, Hemospray rescue treatment was attempted, with successful hemostasis achieved in all patients. In two of the four cases, hemostasis was achieved using two consecutive applications of the powder. One patient underwent a second Hemospray application due to rebleeding, which occurred 4 days after the first treatment. Nor, further re-bleeding or other adverse events were observed during the 1-month follow-up in any of the patients. Actual hemostatic techniques include injection therapy (epinephrine, sclerosants or, fibrin glue), thermal therapy (heater probe, bipolar cautery, argon plasma coagulation [APC]), and mechanical therapy (standard metal clips, overthe-scope clips, and band ligation). However, these techniques do have some limitations, especially in the case of massive bleeding obscuring the endoscopic view. Contact thermal therapy, for example, is associated with a perforation rate up to 2.5 % as well as the potential for causing ischemia and further tissue damage. Clip application
requires accurate localization of the bleeding source and precise deployment for maximum benefits, rendering it inadequate in cases in which the hemorrhagic lesion is located at a difficult angle or is too tangential to view. One possible major advantage of the hemostatic powder over the current endoscopic modalities may be the ability to control diffuse bleeding from a larger area, for which hemoclip placement is not feasible. APC can overcome this problem, but is associated with a delicate technical balance between achieving durable hemostasis and the risk of perforation. The advent of Hemospray potentially obviates the need for en face therapeutic positioning and eliminates the risk of perforation and damage to adjacent tissue. However, the pressure of the carbon dioxide gas used for application needs to be considered as a potential source of adverse events, which seems, in our opinion, even more important in the case of IC. This study shows the promising results of Hemospray rescue therapy in the colon for acute IC-related LGIB after failure of conventional endoscopic techniques. Our results highlight the feasibility and usefulness of this approach when, in an emergency, the endoscopist faces difficult-to-treat bleedings and conventional hemostatic strategies fail, as is the case of IC-related refractory bleeding or the case of patients for whom anticoagulation is necessary and cannot be suspended, such as ECMO-treated patients. The Bnon-contact nature^ of Hemospray makes it desirable in situations involving larger areas of mucosa that would not otherwise be amenable to more traditional, targeted therapies. Though no conclusions can be drawn on the basis of this study alone, with its limited number of treated patients, these promising preliminary data should reasonably prompt future and larger studies to determine the most appropriate indications for use and the limitations of this novel rescue hemostatic therapy.
LETTER TO THE EDITOR
Hemospray rescue treatment of severe refractory bleeding associated with ischemic colitis: a case series Antonino Granata 1 & Gabriele Curcio 1 & Luca Barresi 1 & Dario Ligresti 1 & Ilaria Tarantino 1 & Rosalba Orlando 1 & Mario Traina 1
Accepted: 11 April 2015 # Springer-Verlag Berlin Heidelberg 2015
Dear Editor: Ischemic colitis is a vascular condition of inadequate blood flow in the colon, which leads to colonic inflammation and mucosal damage with ulcerations; it is associated with significant morbidity and mortality. Multiple anecdotal case reports and case series have described associations of ischemic colitis with vascular surgery and vascular thromboembolism. Bleeding associated with nausea, vomiting, diarrhea, concomitant ischemic stroke, and ileus is quite common. Flexible sigmoidoscopy or complete colonoscopy is crucial for obtaining a histologic diagnosis, determining the severity of the IC, and treating the source of bleeding. Frequently used treatment modalities are injections, mechanical and thermal. However, these modalities may be not suitable in the case of tangentially located bleeding sites and diffusely bleeding lesions or when massive hemorrhage obscures the endoscopic view. Furthermore, thermo-coagulation, when suitable due to its in-depth application, can result in adverse events. Hemospray is an easily applicable hemostatic powder that has been shown to be effective in both focused and diffusely active bleeding lesions of the gastrointestinal tract. Evidence of its efficacy in the lower gastrointestinal bleeding (LGIB) is very limited, based on extrapolations of what happens in upper gastrointestinal bleeding, and on small series of patients. In Europe, Hemospray is not licensed for use in the lower gastrointestinal tract, so its use in this area is currently off-
* Antonino Granata [email protected] 1
Endoscopy Service, Department of Diagnostic and Therapeutic Services, IRCCS - ISMETT (Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione), Via Tricomi 5, 90127 Palermo, Italy
label. To date, its use in the lower gastrointestinal tract is licensed only in Canada. We present our experience with Hemospray rescue treatment of four cases of life-threatening IC-related LGIB after failure of conventional endoscopic techniques. From April, 2013, to August, 2014, all patients who underwent Hemospray treatment for IC-related LGIB were retrospectively analyzed. Endoscopic hemostatic interventions were performed exclusively by interventional endoscopists experienced in therapeutic colonoscopy and specifically trained in Hemospray application. Training consisted of 1 day of hands-on training on an ex vivo model. Each procedure was performed using a high-definition colonoscope (CF-H190L—Olympus Europa SE & CO. KG, Hamburg, Germany). A diagnosis of IC was histologically obtained with biopsies in all patients. After failure of conventional hemostatic techniques, Hemospray was deployed onto the active bleeding site through dedicated catheters and propelled by short bursts of carbon dioxide until complete hemostasis was achieved. Success was defined as persistent hemostasis after 3–5 min of visual inspection following Hemospray application. Immediately after each Hemospray application, CO2 was carefully suctioned to reduce bowel wall thinning and its potentially associated risk of perforation, even if it should be noted that suctioning during Hemospray treatment can lead to scope channel obstruction. The use of both catheters included in the box was necessary to complete Hemospray treatment for each procedure, due to catheter kinking or obstruction during application. In one case, in order to proceed with the treatment, an additional standard biliary Luer-lock 10 Fr catheter (FS-OA-10 Cook Medical, Winston-Salem, NC) was used. A total of four intensive care unit patients (three men; median age 50, range 22–66), with severe hypotension,
Int J Colorectal Dis
underwent Hemospray rescue treatment of active LGIB ulcer secondary to IC, after failure of conventional techniques. All patients were on antithrombotic therapy at the time of bleeding (acetyl salicylic acid, n=2; low molecular weight heparin, n=2). One of the patients was under extra-corporeal membrane oxygenation (ECMO) treatment requiring continuous heparin infusion. Clinical presentations consisted of profuse hematochezia and hypovolemic shock requiring blood transfusion and maximal medical support in all patients. Concerning the source of bleeding, endoscopy showed an oozing bleeding ulcer localized in one cecum, one ascending colon, one splenic flexure, and one descending colon; the mean ulcer diameter was 32 mm (range 25–50). At the time of emergency endoscopy, following unsuccessful hemostasis with hemoclip placement and epinephrine injection, and in consideration of the associated risks of thermal therapy, Hemospray rescue treatment was attempted, with successful hemostasis achieved in all patients. In two of the four cases, hemostasis was achieved using two consecutive applications of the powder. One patient underwent a second Hemospray application due to rebleeding, which occurred 4 days after the first treatment. Nor, further re-bleeding or other adverse events were observed during the 1-month follow-up in any of the patients. Actual hemostatic techniques include injection therapy (epinephrine, sclerosants or, fibrin glue), thermal therapy (heater probe, bipolar cautery, argon plasma coagulation [APC]), and mechanical therapy (standard metal clips, overthe-scope clips, and band ligation). However, these techniques do have some limitations, especially in the case of massive bleeding obscuring the endoscopic view. Contact thermal therapy, for example, is associated with a perforation rate up to 2.5 % as well as the potential for causing ischemia and further tissue damage. Clip application
requires accurate localization of the bleeding source and precise deployment for maximum benefits, rendering it inadequate in cases in which the hemorrhagic lesion is located at a difficult angle or is too tangential to view. One possible major advantage of the hemostatic powder over the current endoscopic modalities may be the ability to control diffuse bleeding from a larger area, for which hemoclip placement is not feasible. APC can overcome this problem, but is associated with a delicate technical balance between achieving durable hemostasis and the risk of perforation. The advent of Hemospray potentially obviates the need for en face therapeutic positioning and eliminates the risk of perforation and damage to adjacent tissue. However, the pressure of the carbon dioxide gas used for application needs to be considered as a potential source of adverse events, which seems, in our opinion, even more important in the case of IC. This study shows the promising results of Hemospray rescue therapy in the colon for acute IC-related LGIB after failure of conventional endoscopic techniques. Our results highlight the feasibility and usefulness of this approach when, in an emergency, the endoscopist faces difficult-to-treat bleedings and conventional hemostatic strategies fail, as is the case of IC-related refractory bleeding or the case of patients for whom anticoagulation is necessary and cannot be suspended, such as ECMO-treated patients. The Bnon-contact nature^ of Hemospray makes it desirable in situations involving larger areas of mucosa that would not otherwise be amenable to more traditional, targeted therapies. Though no conclusions can be drawn on the basis of this study alone, with its limited number of treated patients, these promising preliminary data should reasonably prompt future and larger studies to determine the most appropriate indications for use and the limitations of this novel rescue hemostatic therapy.
