Effectiveness of TC-325 (Hemospray) for treatment of diffuse or refractory upper gastrointestinal bleeding – a single center experience

Abstract

Background and study aims TC-325 (Hemospray, Cook Medical) is a powder agent for endoscopic hemostasis in patients with upper gastrointestinal bleeding (UGIB). Although most publications are based on case-reports and retrospective studies, data on efficacy are promising. Here we report our experience with TC-325 for diffuse or refractory UGIB. Patients and methods Data on patients receiving TC-325 for endoscopic hemostasis from November 2013 to February 2017 at our center were analyzed retrospectively. Primary endpoints were technical success (successful immediate hemostasis) and clinical success (effective hemostasis and no recurrent bleeding). Secondary endpoints were recurrent bleeding within 3 and 7 days, hospital mortality and TC-325 associated complications. TC-325 was used for bleeding not amenable to standard endoscopic treatment (e. g. diffuse bleeding) or as salvage therapy after failure of conventional methods Results Fifty-two patients received TC-325 treatment. Most of the patients were treated for peptic ulcer bleeding (18/52 patients, 34.6 %) and post-interventional bleeding (13/52 patients, 25 %). Hemospray was used in 23/52 (44.2 %) patients as monotherapy and in 29/52 (55.8 %) patients as a salvage therapy. Application of the powder on the bleeding source was successful in all patients with no therapy-related adverse events (AEs). Immediate hemostasis was achieved in 51/52 (98.1 %) patients. Recurrent bleeding within 3 and 7 days was observed in 22/51 and 25/51 patients respectively (43.1 % and 49 %). The overall clinical success was 56.9 % on day 3 and 51 % on day 7. Total mortality was 15.4 % (8 patients), bleeding associated mortality was 3.8 % (2 patients). There were no therapy-related AEs. Conclusions TC-325 showed a high technical success rate as monotherapy for bleeding sources not amenable to standard methods or as an “add-on” therapy after unsuccessful hemostasis. However, rebleeding was frequent in this cohort and further studies are warranted to exactly define a treatment algorithm for TC-325 use.

Efficacy of Hemospray in non-variceal upper gastrointestinal bleeding: a systematic review with meta-analysis

“…This systematic review and meta-analysis evaluated the efficacy of Hemospray in the management of non-variceal Baracat et al [10] Baracat et al [10] Kwek et al [11] Kwek et al [11] Pittayanon et al [17] Pittayanon et al [17] Pittayanon et al [18] Sinha et al [19] Kwek et al [11] Pittayanon et al [17] Sinha et al [19] Arena et al [6] Cahyadi et al [12] Giles et al [13] Hadara et al [14] Hagel et al [15] Holster et al [16] Sinha et al [19] Sulz et al [20] Vitali et al [22] Yau et al [23] Smith et al [24] Masci et al [25] Alzoubaidi et al [27] Sandiago et al [ upper GIB and demonstrated a high clinical and technical success rate. The early, delayed and aggregate rebleeding rates were comparable to those in the control group.…”

“…However, the hemostatic time of Hemospray may be called into question. Two studies have attempted second-look endoscopy post-Hemospray application for non-variceal bleeds [12,34]. Cahyadi et al noted that 36.5% of patients treated with Hemospray receiving second-look endoscopy had rebleeding at the time of endoscopy; 68.4% of these patients received a second application of Hemospray, which adequately provided hemostasis [12].…”

“…The I 2 statistic was used for identifying heterogeneity: I 2 values of 0%, 25%, 50% and 75% were interpreted as absent, low, moderate and high heterogeneity, respectively [8]. Meta-regression analysis was conducted for Baracat et al [10] Kwek et al [11] Pittayanon et al [17] Pittayanon et al [18] Arena et al [6] Cahyadi et al [12] Giles et al [13] Hadara et al [14] Hagel et al [15] Holster et al (16] Sinha et al [19] Sulz et al [20] Vitali et al [22] Yau et al [23] Smith et al [24] Masci et al [25] Alzoubaidi et al [27] Sandiago et al [28] Summary Sung et al [21] Leblanc et al [ Baracat et al [10] Kwek et al [11] Kwek et al [11] Pittayanon et al [17] Pittayanon et al [18] Pittayanon et al [17] Arena et al [6] Cahyadi et al [12] Sinha et al [19] Giles et al [13] Hadara et al [14] Hagel et al [15] Holster et al [16] Sinha et al [19] Sulz et al [20] Vitali et al [22] Yau et al [23] Smith et al [24] Masci et al [25] Alzoubaidi et al [27] Sandiago et al [28] Summary…”

“…1). After a comprehensive review of the published literature, a total of 20 studies met the inclusion and exclusion criteria for this meta-analysis [6,[10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28]. All included studies were published between 2011 and 2019.…”

Management gastrointestinaler Blutungen unter Antikoagulation

“…Die Substanzen haben möglicherweise einen Stellenwert bei diffusen Blutungen, wie z. B. Tumorblutungen [18,19] und sind aktuell als Reserveverfahren oder additive Option zu erachten, wenn die Standardtherapie versagt oder nicht ausreichend ist. In der Erstlinientherapie haben Hämostasesprays aktuell keinen Stellenwert.…”