One hundred and one over-the-scope-clip applications for severe gastrointestinal bleeding,leaks and fistulas

AIM: To investigate the efficacy and clinical outcome of patients treated with an over-the-scope-clip(OTSC) system for severe gastrointestinal hemorrhage, perforations and fistulas.METHODS: From 02-2009 to 10-2012, 84 patients were treated with 101 OTSC clips. 41 patients(48.8%) presented with severe upper-gastrointestinal(GI) bleeding, 3(3.6%) patients with lower-GI bleeding, 7 patients(8.3%) underwent perforation closure, 18 patients(21.4%) had prevention of secondary perforation, 12 patients(14.3%) had control of secondary bleeding after endoscopic mucosal resection or endoscopic submucosal dissection(ESD) and 3 patients(3.6%) had an intervention on a chronic fistula. RESULTS: In 78/84 patients(92.8%), primary treatment with the OTSC was technically successful. Clinical primary success was achieved in 75/84 patients(89.28%). The overall mortality in the study patients was 11/84(13.1%) and was seen in patients with life threatning upper GI hemorrhage. There was no mortality in any other treatment group. In detail OTSC application lead to a clinical success in 35/41(85.36%) patients with upper GI bleeding and in 3/3 patients with lower GI bleeding. Technical success of perforation closure was 100% while clinical success was seen in 4/7 cases(57.14%) due to attendant circumstances unrelated to the OTSC. Technical and clinic success was achieved in 18/18(100%) patients for the prevention of bleeding or perforation after endoscopic mucosal resection and ESD and in 3/3 cases of fistula closure. Two application-related complications were seen(2%).CONCLUSION: This largest single center experience published so far confirms the value of the OTSC for GI emergencies and complications. Further clinical experience will help to identify optimal indications for its targeted and prophylactic use.     

Multipurpose use of the over-the-scope-clip system(“Bear claw”) in the gastrointestinal tract:Swiss experience in a tertiary center

AIM:To evaluate the outcome of over-the-scope-clip system(OTSC)for endoscopic treatment of various indications in daily clinical practice in Switzerland.METHODS:This prospective,consecutive case series was conducted at a tertiary care hospital from September 2010 to January 2014.Indications for OTSC application were fistulae,anastomotic leakage,perforation,unroofed submucosal lesion for biopsy,refractory bleeding,and stent fixation in the gastrointestinal(GI)tract.Primary technical success was defined as the adequate deployment of the OTSC on the target lesion.Clinical success was defined as resolution of the problem;for instance,no requirement for surgery or further endoscopic intervention.In cases of recurrence,retreatment of a lesion with a second intervention was possible.Complications were classified into those related to sedation,endoscopy,or deployment of the clip.RESULTS:A total of 28 OTSC system applications werecarried out in 21 patients[median age 64 years(range42-85),33%females].The main indications were fistulae(52%),mostly after percutaneous endoscopic gastrostomy tube removal,and anastomotic leakage after GI surgery(29%).Further indications were unroofed submucosal lesions after biopsy,upper gastrointestinal bleeding,or esophageal stent fixation.The OTSC treatments were applied either in the upper(48%)or lower(52%)GI tract.The mean lesion size was 8 mm(range:2-20 mm).Primary technical success and clinical success rates were 85%and 67%,respectively.In53%of cases,the suction method was used without accessories(e.g.,twin grasper or tissue anchor).No endoscopy-related or OTSC-related complications were observed.CONCLUSION:OTSC is a useful tool for endoscopic closure of various GI lesions,including fistulae and leakages.Future randomized prospective multicenter trials are warranted.     

Multiple infusions of mesenchymal stromal cells induce sustained remission in children with steroid‐refractory,grade III–IV acute graft‐versus‐host disease

Mesenchymal stromal cell (MSC) infusions have been reported to be effective in patients with steroid‐refractory, acute graft‐versus‐host disease (aGvHD) but comprehensive data on paediatric patients are limited. We retrospectively analysed a cohort of 37 children (aged 3 months‐17 years) treated with MSCs for steroid‐refractory grade III–IV aGvHD. All patients but three received multiple MSC infusions. Complete response (CR) was observed in 24 children (65%), while 13 children had either partial (n = 8) or no response (n = 5). Cumulative incidence of transplantation‐related mortality (TRM) in patients who did or did not achieve CR was 17% and 69%, respectively (P = 0·001). After a median follow‐up of 2·9 years, overall survival (OS) was 37%; it was 65% vs. 0% in patients who did or did not achieve CR, respectively (P = 0·001). The median time from starting steroids for GvHD treatment to first MSC infusion was 13 d (range 5–85). Children treated between 5 and 12 d after steroid initiation showed a trend for better OS (56%) and lower TRM (17%) as compared with patients receiving MSCs 13–85 d after steroids (25% and 53%, respectively; P = 0·22 and 0·06, respectively). Multiple MSC infusions are safe and effective for children with steroid‐refractory aGvHD, especially when employed early in the disease course.     

Efficacy and safety of over-the-scope clip: Including complications after endoscopic submucosal dissection

AIM: To retrospectively review the results of over-thescope clip (OTSC) use in our hospital and to examine the feasibility of using the OTSC to treat perforations after endoscopic submucosal dissection (ESD). METHODS: We enrolled 23 patients who presented with gastrointestinal (GI) bleeding, fistulae and perforations and were treated with OTSCs (Ovesco Endoscopy GmbH, Tuebingen, Germany) between November 2011 and September 2012. Maximum lesion size was defined as lesion diameter. The number of OTSCs to be used per patient was not decided until the lesion was completely closed. We used a twin grasper (Ovesco Endoscopy GmbH, Tuebingen, Germany) as a grasping device for all the patients. A 9 mm OTSC was chosen for use in the esophagus and colon, and a 10 mm device was used for the stomach, duodenum and rectum. The overall success rate and complications were evaluated, with a particular emphasis on patients who had undergone ESD due to adenocarcinoma. In technical successful cases we included not only complete closing by using OTSCs, but also partial closing where complete closure with OTSCs is almost difficult. In overall clinical successful cases we included only complete closing by using only OTSCs perfectly. All the OTSCs were placed by 2 experienced endoscopists. The sites closed after ESD included not only the perforation site but also all defective ulcers sites.RESULTS: A total of 23 patients [mean age 77 years (range 64-98 years)] underwent OTSC placement during the study period. The indications for OTSC placement were GI bleeding (n = 9), perforation (n = 10), fistula (n = 4) and the prevention of post-ESD duodenal artificial ulcer perforation (n = 1). One patient had a perforation caused by a glycerin enema, after which a fistula formed. Lesion closure using the OTSC alone was successful in 19 out of 23 patients, and overall success rate was 82.6%. A large lesion size (greater than 20 mm) and a delayed diagnosis (more than 1 wk) were the major contributing factors for the overall unsuccessful clinical case     

Over-the-scope clip placement for closure of gastrointestinal fistula,postoperative leaks and refractory gastrointestinal bleed

Introduction

The over-the-scope clip (OTSC) has been successfully used in the closure of fistula, perforation, dehiscence, and endoscopic hemostasis. We describe our experience with the OTSC application.

Methods

Between April 2014 and April 2015, seven patients underwent OTSC application. In four patients, OTSC was applied for the closure of esophageal fistula, one had OTSC closure of persistent gastrocutaneous fistula after percutaneous endoscopic gastrostomy removal, and OTSC was applied in duodenum in two patients, for duodenal Dieulafoy’s lesion after failed conventional endotherapy and massive rebleed in one and duodenal perforation in another.

Results

All procedures had technical success with no immediate complication related to OTSC application. Patients were followed up for every month with mean duration of follow up 10.2 months. One patient with bronchoesophageal fistula had development of another fistulous opening above the site of OTSC placement, which was successfully closed with another OTSC. One patient had superficial esophageal wall ulcer opposite the OTSC but it healed spontaneously.

Conclusion

OTSC provided safe and successful closure in a number of settings.

     

Over‐the‐scope clip for acute esophageal variceal bleeding

Over‐the‐scope clip (OTSC) has been reported to control non‐variceal bleeding; however, the use of this device for acute variceal hemorrhage (AVH) is very limited. We report our experience regarding the use of OTSC in patients with AVH in terms of technical success and safety. A retrospective clinical experience case series study was conducted from October 2017 to June 2019 at two tertiary care centers. Adult patients with AVH as a result of small varices managed with OTSC after endoscopic band ligation (EBL) failure were enrolled. Standard gastroscope and OTSC ‘type a’ with a cap of 11 mm in diameter were used in all procedures. Total of five patients with chronic liver disease (Child‐Pugh score ≤8) and portal hypertension (hepatic venous pressure gradient, mean 14.4 ± 1.3 mmHg) were included. Four of them presented collapse of the bleeding varix, and one had wall disruption associated with fibrosis secondary to prior banding. We were able to stop AVH in all patients without clip‐related adverse events during a 30‐day follow‐up period. Two patients developed solid food dysphagia after 3 months of clip deployment that resolved after removal using a bipolar cutting device. Twin grasper or anchor were not used to aid or facilitate the approximation of opposite edges in any patient. No additional local therapies or new endoscopic session for variceal eradication were required. This case series shows preliminary success controlling AVH with OTSC after EBL failure in patients with small varices. Esophageal dysphagia may appear as a complication during follow up but it can be resolved by clip removal.     

Front‐line,dose‐escalated immunochemotherapy is associated with a significant progression‐free survival advantage in patients with double‐hit lymphomas: a systematic review and meta‐analysis

‘Double‐hit lymphomas’ (DHL), defined by concurrent MYC and BCL2 (or, alternatively, BCL6) rearrangements, have a very poor outcome compared to standard‐risk, diffuse large B‐cell lymphomas (DLBCL). Consequently, dose‐intensive (DI) therapies and/or consolidation with high‐dose therapy and transplant have been explored in DHL, although benefit has been debated. This meta‐analysis compared survival outcomes in DHL patients receiving dose‐escalated regimens [DI: R‐Hyper‐CVAD (rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone) or R‐CODOX‐M/IVAC (rituximab, cyclophosphamide, doxorubicin, vincristine, methotrexate/ifosfamide, etoposide, high dose cytarabine); or intermediate‐dose: R‐EPOCH (rituximab, etoposide, doxorubicin, cyclophosphamide, vincristine, prednisone)] versus standard‐dose regimens (R‐CHOP; rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) in the first‐line setting. Data were synthesized to estimate hazard ratios of dose‐escalated treatments versus R‐CHOP using a Weibull proportional hazards model within a Bayesian meta‐analysis framework. Eleven studies examining 394 patients were included. Patients were treated with either front‐line R‐CHOP (n = 180), R‐EPOCH (n = 91), or R‐Hyper‐CVAD/rituximab, methotrexate, cytarabine (R‐M/C), R‐CODOX‐M/R‐IVAC (DI) (n = 123). Our meta‐analysis revealed that median progression‐free survival (n = 350) for the R‐CHOP, R‐EPOCH and DI groups was 12·1, 22·2, and 18·9 months, respectively. First‐line treatment with R‐EPOCH significantly reduced the risk of a progression compared with R‐CHOP (relative risk reduction of 34%; P = 0·032); however, overall survival (n = 374) was not significantly different across treatment approaches. A subset of patients might benefit from intensive induction with/without transplant. Further investigation into the role of transplant and novel therapy combinations is necessary.     

Clinico‐immunological outcomes of HCV‐cured cryoglobulinemia: Lower relapse rate with interferon‐based than interferon‐free therapy

Sustained virological response (SVR) obtained with interferon (IFN) or with direct‐acting antivirals (DAAs) is commonly followed by response of hepatitis C virus (HCV)‐associated mixed cryoglobulinemia vasculitis (MCV), but relapse of MCV despite SVR has been reported in several patients after DAAs and rarely after IFN. Since relapses could have been overlooked in studies with IFN, we retrospectively compared the outcomes of MCV in SVR patients treated with DAAs (n = 70) or IFN (n = 39) followed‐up, respectively, for 30.5 (range 11‐51) or 48 months. Groups were comparable for demographics and clinics and response rates of MCV were similar (92% and 86%); however, DAA‐treated patients less efficiently reduced cryoglobulins (P = .006) and circulating B‐cell clones (P = .004), and had more frequently relapses of MCV (18% vs 3%, P = .028) and need for rituximab therapy (P = .01). Although largely inferior on an intention‐to‐treat basis, IFN may be superior to DAAs on clinico‐immunological outcomes possibly owing to its antiproliferative activity.     

Biliopancreatic and biliary leak after pancreatoduodenectomy treated by percutaneous transhepatic biliary drainage

BackgroundComplementary to percutaneous intra-abdominal drainage, percutaneous transhepatic biliary drainage (PTBD) might ameliorate healing of pancreatic fistula and biliary leakage after pancreatoduodenectomy by diversion of bile from the site of leakage. This study evaluated technical and clinical outcomes of PTBD for this indication.MethodsAll patients undergoing PTBD for leakage after pancreatoduodenectomy were retrospectively evaluated in two tertiary pancreatic centers (2014–2019). Technical success was defined as external biliary drainage. Clinical success was defined as discharge with a resolved leak, without additional surgical interventions for anastomotic leakage other than percutaneous intra-abdominal drainage.ResultsFollowing 822 pancreatoduodenectomies, 65 patients (8%) underwent PTBD. Indications were leakage of the pancreaticojejunostomy (n = 25; 38%), hepaticojejunostomy (n = 15; 23%) and of both (n = 25; 38%). PTBD was technically successful in 64 patients (98%) with drain revision in 40 patients (63%). Clinical success occurred in 60 patients (94%). Leakage resolved after median 33 days (IQR 21–60). PTBD related complications occurred in 23 patients (35%), including cholangitis (n = 14; 21%), hemobilia (n = 7; 11%) and PTBD related bleeding requiring re-intervention (n = 4; 6%). In hospital mortality was 3% (n = 2).ConclusionAlthough drain revisions and complications are common, PTBD is highly feasible and appears to be effective in the treatment of biliopancreatic leakage after pancreatoduodenectomy.     

Risk of hospitalization for upper gastrointestinal tract complications associated with non‐selective non‐steroidal anti‐inflammatory drugs in Malaysia: a retrospective case control study

Aims: To assess the association between non‐steroidal anti‐inflammatory drug (NSAID) use and upper gastrointestinal (GI) tract‐related hospitalizations and to evaluate inpatient healthcare resource utilization associated with these complications in Malaysia. Methods: A retrospective case control study was performed using medical records of patients admitted to two Malaysian hospitals during 1999 and 2000. Cases were identified based on mode of presentation at hospital admission. One control was identified for each case, matched by age, sex and admission date. NSAID exposure was determined by drug use during one year prior to admission. Conditional logistic regression analysis was used to determine the association between NSAID use and upper GI complications, adjusting for predictors. Results: The 273 cases were significantly more likely to have used NSAIDs in the year prior to hospitalization than controls (27.8%vs. 6.2% of patients; P < 0.0001). Conditional logistic regression analysis adjusting for other predictors showed that the odds of being hospitalized for upper GI tract complications were 4.1 times higher among NSAID users than non‐users (95% CI = 1.88–9.12). Other risk factors for GI‐related hospitalizations were a history of upper GI tract complications (OR = 5.8, 95% CI = 1.28–26.53), use of gastroprotective agents (OR = 5.3, 95% CI = 1.67–16.79), and use of antacids (OR = 5.0, 95% CI = 2.10–11.91) in the previous year. Conclusion: This study demonstrated that NSAID exposure was significantly higher among patients hospitalized for GI‐related complications than for other reasons, indicating that NSAID use is an independent risk factor for upper GI tract complications in this Malaysian sample.     

Community‐acquired respiratory virus lower respiratory tract disease in allogeneic stem cell transplantation recipient: Risk factors and mortality from pulmonary virus‐bacterial mixed infections

Risk factors (RFs) and mortality data of community‐acquired respiratory virus (CARVs) lower respiratory tract disease (LRTD) with concurrent pulmonary co‐infections in the setting of allogeneic hematopoietic stem cell transplantation (allo‐HSCT) is scarce. From January 2011 to December 2017, we retrospectively compared the outcome of allo‐HSCT recipients diagnosed of CARVs LRTD mono‐infection (n = 52, group 1), to those with viral, bacterial, or fungal pulmonary CARVs LRTD co‐infections (n = 15, group 2; n = 20, group 3, and n = 11, group 4, respectively), and with those having bacterial pneumonia mono‐infection (n = 19, group 5). Overall survival (OS) at day 60 after bronchoalveolar lavage (BAL) was significantly higher in group 1, 2, and 4 compared to group 3 (77%, 67%, and 73% vs 35%, respectively, P = .012). Recipients of group 5 showed a trend to better OS compared to those of group 3 (62% vs 35%, P = .1). Multivariate analyses showed bacterial co‐infection as a RF for mortality (hazard ratio[HR] 2.65, 95% C.I. 1.2‐6.9, P = .017). We identified other 3 RFs for mortality: lymphocyte count <0.5 × 10⁹/L (HR 2.6, 95% 1.1‐6.2, P = .026), the occurrence of and CMV DNAemia requiring antiviral therapy (CMV‐DNAemia‐RAT) at the time of BAL (HR 2.32, 95% C.I. 1.1‐4.9, P = .03), and the need of oxygen support (HR 8.3, 95% C.I. 2.9‐35.3, P = .004). CARV LRTD co‐infections are frequent and may have a negative effect in the outcome, in particular in the context of bacterial co‐infections.     

Associations between drugs and small‐bowel mucosal bleeding: Multicenter capsule‐endoscopy study

Background and Aim

Although several drugs may induce small‐bowel mucosal injuries, it is unclear whether these injuries contribute to overt small‐bowel bleeding. This study was designed to evaluate the associations between drug use and small‐bowel mucosal injury and between these mucosal injuries and overt bleeding in a disease‐relevant population.

Methods

We retrospectively studied patients with suspected small‐bowel diseases who underwent capsule endoscopy between 2010 and 2013. Drug exposure, Charlson Comorbidity Index, smoking, and alcohol consumption were assessed before capsule endoscopy. Adjusted odds ratios (AOR) and confidence intervals (CI) were estimated for small‐bowel mucosal injury and small‐bowel overt bleeding.

Results

In total, 850 patients were analyzed during the study period. Median age was 64 years, and 544 patients (64.0%) were men. Among the patients with small‐bowel mucosal injury (n = 60) and without mucosal injury (n = 705), use of non‐steroidal anti‐inflammatory drugs (NSAIDs) (AOR 1.8, 95% CI 1.01–3.31) was significantly associated with an increased risk of small‐bowel mucosal injury compared with non‐use. Patients with small‐bowel mucosal injury with overt bleeding (n = 85) and without overt bleeding (n = 60) were compared, and no significant difference between the groups in the usage rates for NSAIDs, thienopyridine, other antiplatelets, anticoagulants, acetaminophen, tramadol hydrochloride, or steroids was revealed, even after adjusting for confounders.

Conclusion

Although the use of NSAIDs was significantly associated with an increased risk of small‐bowel mucosal injury, no significant associations were observed between the use of such drugs and small‐bowel overt bleeding.     

Clinical experience with a new endoscopic over-the-scope clip system for use in the GI tract

BackgroundThe newly designed over-the-scope clip (OTSC) seems to overcome several limitations of current clipping system, such as size and opening–closing force, allowing better control of gastric or colonic bleeding and/or deep wall defect or perforation.AimsThe aim of this retrospective analysis was to describe the new endoscopic device and evaluate our first clinical experience.Patients and methodsWe treated with the OTSC system 9 patients (range, 58–85 years; 6 men, 3 women) with bleeding and/or deep wall lesions of the GI tract. The OTSC system is composed of an application cap, which is mounted onto the distal tip of the endoscope and a connected releasing mechanism, installed on the handle of the scope. The rotation of the handle allows the release of the clip by a two tube sliding mechanism.ResultsAll applications resulted successful, i.e. haemostasis was achieved, and/or wall defects could be closed. No complication was observed that could be ascribed to the clip itself or to the technique.ConclusionsThe OTSC system is a new endoscopic tool for compression of large tissue areas and its indications are nonvaricose bleedings difficult to control and lesions or perforations of the GI tract. The initial clinical use of this clipping device proved to be efficient and effective.     

Incidence and Etiology of Overt Gastrointestinal Bleeding in Adult Patients with Aplastic Anemia

Patients with thrombocytopenia caused by various neoplastic and primary bone marrow diseases are susceptible to major hemorrhage. There are few reports addressing the incidence and outcome of gastrointestinal (GI) bleeding in patients with aplastic anemia characterized by long-standing thrombocytopenia. We sought to retrospectively determine the incidence, etiology, clinical outcomes, and risk factors associated with overt GI bleeding in patients with aplastic anemia. We analyzed the medical records of 508 patients with aplastic anemia after excluding patients below 15 years of age or those who underwent stem cell transplantation between January 1, 2002, and December 31, 2007. A total of 32 patients developed overt GI bleeding during this period. We evaluated the site, etiology, outcomes, and major risk factors in these patients who developed GI bleeding episodes. The incidence of GI bleeding was 6.3% (32 of 508 patients) in adult patients with aplastic anemia. The incidence increased to 12.6% (28 of 222 patients) in patients with severe disease. One patient died from massive GI bleeding. Bleeding sites included the esophagus (two patients, 6.3%), stomach (five, 16.3%), duodenum (two, 6.3%), small intestine (five, 15.6%), large intestine (seven, 21.6%), and unknown site (11, 34.4%). Lower GI bleeds mainly caused by neutropenic enterocolitis (NEC) and solitary ulcer developed more frequently than upper GI bleeds. The major risk factors for GI bleeding included old age (P = 0.004, odds ratio (OR) = 1.039), severe aplastic anemia (P < 0.001, OR = 11.934), non-response to therapy (P = 0.001, OR = 5.652), and major bleeding history in another organ (P < 0.001, OR = 6.677). Overt GI bleeding in patients with aplastic anemia more frequently develops in the lower tract than in the upper tract. The risk of GI bleeding is higher in patients with the following risk factors: older age, severe disease, poor response to treatment, and major bleeding history in another organ.     

Efficacy and safety of low‐dose lenalidomide plus dexamethasone in patients with relapsed or refractory POEMS syndrome

Although autologous stem cell transplantation or melphalan‐based chemotherapy has significantly improved the prognosis of POEMS syndrome, a few patients will relapse or be refractory to primary therapy, and there is a lack of studies regarding these patients. In this study, we used low‐dose lenalidomide (10 mg daily) and dexamethasone (40 mg, once weekly) to treat twelve patients with relapsed (n = 8) or refractory (n = 4) POEMS syndrome. After a median follow‐up time of 20 months, the overall hematologic response rate was 77% with 44% having a complete response. Eight (67%) patients had neurological response, and the median overall neuropathy limitation scale score was reduced from 3 (range, 1–9) to 2 (range, 0–6). Serum vascular endothelial growth factor response rate was 91% and 46% of patients had normal serum VEGF levels. One patient had progression of the disease 3 months after the end of treatment and subsequently died from the disease. Therefore, the estimated 2 year overall survival and progression‐free survival were 92%. The low‐dose lenalidomide and dexamethasone regimen was well tolerated, with no treatment‐related death or any grade 3 or 4 toxicity. In conclusion, low‐dose lenalidomide plus dexamethasone therapy is an effective and safe regimen for patients with relapsed or refractory POEMS syndrome.     

New predictive model for acute gastrointestinal bleeding in patients taking oral anticoagulants: A cohort study

Background and Aim

The study developed a predictive model of long‐term gastrointestinal (GI) bleeding risk in patients receiving oral anticoagulants and compared it with the HAS‐BLED (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile international normalized ratios, Elderly, Drugs/alcohol concomitantly) score.

Methods

The study periodically followed a cohort of 508 patients taking oral anticoagulants (66 direct oral anticoagulants users and 442 warfarin users). Absence of GI bleeding at an initial examination and any subsequent GI bleeding were confirmed endoscopically. The bleeding model was developed by multivariate survival analysis and evaluated by Harrell's c‐index.

Results

During a median follow‐up of 31.4 months, 42 GI bleeds (8.3%) occurred: 42.8% in the upper GI tract, 50.0% in the lower GI tract, and 7.1% in the middle GI tract. The cumulative 5 and 10‐year probability of GI bleeding was 12.6% and 18.5%, respectively. Patients who bled had a significantly higher cumulative incidence of all‐cause mortality (hazard ratio 2.9, P < 0.001). Multivariate analysis revealed that absence of proton pump inhibitor therapy, chronic kidney disease, chronic obstructive pulmonary disease, history of peptic ulcer disease, and liver cirrhosis predicted GI bleeding. The c‐statistic for the new predictive model using these five factors was 0.65 (P < 0.001), higher than the HAS‐BLED score of 0.57 (P = 0.145).

Conclusions

Gastrointestinal bleeding increased the risk of subsequent mortality during follow‐up of anticoagulated patients, highlighting the importance of prevention. The study developed a new scoring model for acute GI bleeding risk based on five factors (no‐proton pump inhibitor use, chronic kidney disease, chronic obstructive pulmonary disease, history of peptic ulcer disease, and liver cirrhosis), which was superior to the HAS‐BLED score.     

COVID‐19 in solid organ transplant recipients: No difference in survival compared to general population

Coronavirus disease 2019 (COVID‐19) may be associated with worse outcome in solid organ transplant (SOT) recipients. We performed a prospective cohort study of hospitalized patients with confirmed diagnosis of COVID‐19, from March 15 to April 30, 2020, at two tertiary hospitals in Emilia‐Romagna Region. SOT recipients were compared with non‐SOT patients. Primary endpoint was all‐cause 30‐day mortality. Relationship between SOT status and mortality was investigated by univariable and multivariable Cox regression analysis. Patients were assessed from COVID‐19 diagnosis to death or 30‐day whichever occurred first. Study cohort consisted of 885 patients, of them 24 SOT recipients (n = 22, kidney, n = 2 liver). SOT recipients were younger, had lower BMI, but higher Charlson Index. At admission they presented less frequently with fever and respiratory failure. No difference in 30‐day mortality between the two groups (19% vs 22.1%) was found; however, there was a trend toward higher rate of respiratory failure (50% vs 33.1%, P = .07) in SOT recipients. Superinfections were more represented in SOT recipients, (50% vs 15.5%, P < .001). At multivariate analysis adjusted for main covariates, there was no association between SOT and 30‐day mortality HR 1.15 (95% CI 0.39‐3.35) P = .79. Our data suggest that mortality among COVID‐19 SOT recipients is similar to general population.     

Add‐on peginterferon alfa‐2a to nucleos(t)ide analogue therapy for Caucasian patients with hepatitis B ‘e’ antigen‐negative chronic hepatitis B genotype D

Nucleos(t)ide analogues (NAs) and peginterferon have complementary effects in chronic hepatitis B, but it is unclear whether combination therapy improves responses in genotype D‐infected patients. We conducted an open‐label study of peginterferon alfa‐2a 180 μg/wk added to ongoing NA therapy in hepatitis B e antigen (HBeAg)‐negative, genotype D‐infected patients with hepatitis B virus DNA <20 IU/mL. The primary endpoint was proportion of patients with ≥50% decline in serum HBsAg by the end of the 48‐week add‐on phase. Seventy patients received treatment, 11 were withdrawn at week 24 for no decrease in HBsAg, and 14 withdrew for other reasons. Response rate (per‐protocol population) was 67.4% (29/43) at week 48 (95% confidence interval [CI]: 51, 81) and 50.9% (28/55) at week 96 (95% CI: 38, 66). Median serum HBsAg decreased throughout peginterferon alfa‐2a treatment and was significantly lower than baseline at weeks 48, 72 and 96 (P < 0.001). Decreases in HBsAg of ≥0.5‐log₁₀ and ≥1‐log₁₀ were documented in 19 (44.2%) and 6 (14.0%) patients at week 48 and 6 (10.9%) and 17 (30.9%) patients at week 96. The proportion of patients with HBsAg <1000, <500, <100 and <10 IU/mL at ≥1 timepoint during treatment was 78.6% (n = 44), 57.1% (n = 32), 21.4% (n = 12) and 7.1% (n = 4). Interferon gamma‐induced protein 10 increased from baseline up to week 48, with week 12 levels significantly associated with response at week 48. Addition of peginterferon alfa‐2a to ongoing NA therapy significantly decreased HBsAg levels in HBeAg‐negative patients with genotype D infection (ClinicalTrials.gov NCT01706575).     

Cardio‐ankle vascular index and cardiovascular disease: Systematic review and meta‐analysis of prospective and cross‐sectional studies

The cardio‐ankle vascular index (CAVI) is a new measure of arterial stiffness that reflects the stiffness from the ascending aorta to the ankle arteries, and demonstrates little dependence on blood pressure during the evaluation. However, a comprehensive assessment of the association of CAVI with cardiovascular disease (CVD) has not been reported. We performed a systematic review to assess the association between CAVI and CVD. We searched for both prospective and cross‐sectional studies using MEDLINE, Embase, and Cochrane from inception until April 11, 2017. We pooled the results using random‐effects models. Among 1519 records, we identified nine prospective studies (n = 5214) and 17 cross‐sectional eligible studies (n = 7309), with most enrolling high CVD risk populations in Asia. All nine prospective studies investigated composite CVD events as an outcome (498 cases including coronary events and stroke) but modeled CAVI inconsistently. The pooled adjusted hazard ratio for CVD events per 1 standard deviation increment of CAVI in four studies was 1.20 (95% CI: 1.05‐1.36, P = 0.006). Of the 17 cross‐sectional studies, 13 studies compared CAVI values between patients with and without CVD and all reported significantly higher values in those with CVD (pooled mean difference in CAVI values 1.28 [0.86‐1.70], P < 0.001). This systematic review suggests a modest association between CAVI and incident CVD risk, and highlights the need for studies assessing CAVI as a predictor of CVD in the general population and non‐Asian countries.