Late Bleeding Research Articles

Normal tissue complication probability modeling for late rectal bleeding after conventional or hypofractionated radiotherapy for prostate cancer

PurposeTo develop a single NTCP model for grade ≥ 2 late rectal bleeding (G2 LRB) after conventional or hypofractionated radiotherapy for prostate cancer. Methods and MaterialsThe development dataset consisted of prostate cancer patients (n = 656) previously randomized to conventional (39 x 2 Gy) or hypofractionated (19 x 3.4 Gy) external beam radiotherapy with N = 89 G2 LRB cases. Candidate predictors were obtained from literature. We fitted five separate logistic regression models to the data, each with one of the following dose parameters as candidate predictors in biological effective dose (BED), assuming α/β = 3 Gy: Equivalent uniform dose (EUD) with n = 0.1, EUD with n = 0.2, the relative volume receiving ≥ 111.9 Gy in BED (V111.9, the equivalent of physical V70 for a conventional schedule), minimum BED to the hottest 0.1 cm3 (D0.1cm3) or 2 cm3 (D2cm3). Previous abdominal surgery was included in every model and fractionation schedule was tested as predictor in each model. A sensitivity analysis was performed by varying the α/β-ratio, n and dose-volume cutoff. ResultsThe pre-selected candidate dosimetric predictor and previous abdominal surgery were significantly associated with the outcome in all five models. Fractionation schedule was eliminated by the backward scheme in only the EUD (n = 0.1), D0.1cm3 and D2cm3-based models. In internal validation these models showed AUC’s of 0.64, 0.60 & 0.62, respectively. The sensitivity analyses showed that EUD models with n ≥ 0.15 and / or α/β ≥ 4 Gy failed, and EUD models based on α/β = 2 Gy with n = 0.05–0.2 showed good fits as well. ConclusionsOur trial data set with different fractionation schedules offered the unique possibility to generate unbiased BED-based models. EUD (n = 0.1), D0.1cm3 and D2cm3 performed overall best in predicting G2 LRB; with α/β = 2 Gy equally good models were obtained. External validation is required to confirm our results.

Validation of the Valve Academic Research Consortium High Bleeding Risk Definition in Patients Undergoing TAVR.

Background: The Valve Academic Research Consortium for High Bleeding Risk (VARC-HBR) has recently introduced a consensus document that outlines risk factors to identify high bleeding risk (HBR) in patients undergoing transcatheter aortic valve replacement (TAVR). The objective of the present study was to evaluate the prevalence and predictive value of the VARC-HBR definition in a contemporary, large-scale TAVR population. Methods: Multicenter study including 10,449 patients undergoing TAVR. Based on consensus, twenty-one clinical and laboratory criteria were identified and classified as major or minor. Patients were stratified as at low, moderate, high, and very high bleeding risk according to VARC-HBR definition. The primary endpoint was the rate of BARC type 3 or 5 bleeding at 1 year, defined as the composite of peri-procedural (within 30 days) or late (after 30 days) bleeding. Results: Patients with at least one VARC-HBR criterion (n=9,267, 88.7%) had a higher risk of BARC 3 or 5 bleeding, proportional to the severity of risk assessment (10.8%, 16.1%, and 24.6% for moderate, high, and very high-risk groups, respectively). However, a comparable rate of bleeding events was observed in the low-risk and moderate-risk groups. The area under ROC curve was 0.58. Patients with VARC-HBR criteria also exhibited a gradual increase in 1-year all-cause mortality, with an up to 2-fold increased mortality risk for high and very high-risk groups (HR: 1.33, 95% CI: 1.04-1.70; and HR: 1.97, 95% CI: 1.53-2.53, respectively). Conclusions: The VARC-HBR consensus offered a pragmatic approach to guide bleeding risk stratification in TAVR. The results of the present study would support the predictive validity of the newly definition and promote its application in clinical practice to minimize bleeding risk and improve patient outcomes.

Outcome of early versus late primary embolization in ruptured brain arteriovenous malformations.

To determine whether patients with a ruptured brain arteriovenous malformation (rBAVM) would benefit from an early embolization. rBAVM treated first by embolization between March 2002 and May 2022 were included. Embolization was defined early (Group 1) when performed within 10 days postbleeding. If later, embolization was considered late (Group 2). Demographic and rBAVM data were compared between the groups. High-risk bleeding components and reasons for deferring embolization were retrieved. Primary endpoint was rebleeding. Secondary endpoints were good functional outcome (FO, modified Rankin Scale mRS ≤ 2) and angiographic occlusion. Predictors of rebleeding and FO were determined by multivariate analysis. 105 patients were recruited (N = 34 in Group 1; N = 71 in Group 2). No rebleeding was noted before, during or after the first embolization session in the early embolization group. Late embolization depended on missed diagnosis and referral pattern. Eleven patients (10.5%) suffered a rebleeding, of whom N = 3 before embolization (only in Group 2), N = 5 periembolization (N = 2 at the second embolization session in Group 1) and N = 3 spontaneous more than 30 days postembolization. More high-risk components were embolized in Group 1 (19/34; 55.9 vs 17/71; 23.9%; p = .011). Rebleeding rates, FO at last FU (90.9% vs 74.3%) and occlusion rates (80.8% vs 88.5%) did not differ between the groups. Glasgow coma scale ≤ 8 predicted rebleeding, rebleeding correlated with poor FO. Early embolization did prevent rebleeding. The overall rebleeding risk was linked to bleeding before late embolization and bleeding at the second embolization. Rebleeding predicted the final FO.

1677: First late rectal bleeding biological NTCP model for multiple fractionation schedules

1677: First late rectal bleeding biological NTCP model for multiple fractionation schedules

Evaluation of an automated clinical decision system with deep learning dose prediction and NTCP model for prostate cancer proton therapy

Objective. To evaluate the feasibility of using a deep learning dose prediction approach to identify patients who could benefit most from proton therapy based on the normal tissue complication probability (NTCP) model. Approach. Two 3D UNets were established to predict photon and proton doses. A dataset of 95 patients with localized prostate cancer was randomly partitioned into 55, 10, and 30 for training, validation, and testing, respectively. We selected NTCP models for late rectum bleeding and acute urinary urgency of grade 2 or higher to quantify the benefit of proton therapy. Propagated uncertainties of predicted ΔNTCPs resulting from the dose prediction errors were calculated. Patient selection accuracies for a single endpoint and a composite evaluation were assessed under different ΔNTCP thresholds. Main results. Our deep learning-based dose prediction technique can reduce the time spent on plan comparison from approximately 2 days to as little as 5 seconds. The expanded uncertainty of predicted ΔNTCPs for rectum and bladder endpoints propagated from the dose prediction error were 0.0042 and 0.0016, respectively, which is less than one-third of the acceptable tolerance. The averaged selection accuracies for rectum bleeding, urinary urgency, and composite evaluation were 90%, 93.5%, and 93.5%, respectively. Significance. Our study demonstrates that deep learning dose prediction and NTCP evaluation scheme could distinguish the NTCP differences between photon and proton treatment modalities. In addition, the dose prediction uncertainty does not significantly influence the decision accuracy of NTCP-based patient selection for proton therapy. Therefore, automated deep learning dose prediction and NTCP evaluation schemes can potentially be used to screen large patient populations and to avoid unnecessary delays in the start of prostate cancer radiotherapy in the future.

Early Experience with EndoRobotic Submucosal Dissection (ERSD): Pathologic and Short-term Outcomes in the First 28 Patients.

To evaluate the safety and feasibility of single-port endorobotic submucosal dissection (ERSD) using the Da Vinci SP platform for the management of rectal neoplasms. Endoscopic submucosal dissection (ESD) offers a potential organ-sparing treatment for advanced colorectal neoplasms but demands high technical skill and a steep learning curve. Advances in semiflexible robotic platforms, such as the Da Vinci SP, promise to simplify this procedure, potentially offering improved outcomes for patients with benign rectal neoplasms. A retrospective analysis of 28 patients who underwent ERSD using the Da Vinci SP platform between 2020 and 2023 was performed. Patient demographics, lesion characteristics, procedure details, outcomes, and complications were reviewed. The primary endpoint was successful en-bloc resection. The cohort had a median age of 60.5 years and a median BMI of 28.2kg/m², predominantly male(67.8%) with ASA categories 2 or 3(82%). Lesions had a median size of 38mm and were located a median of 9cm from the anal verge. The median procedure time was 87.5 minutes. En-bloc resection was achieved in all cases(100%), with no intraoperative complications or mortality. One patient experienced urinary retention, and one had late bleeding requiring blood transfusion. Pathology outcomes included 46.4% tubulovillous adenomas, 21.4% adenocarcinomas, and high-grade dysplasia in 53.6% of patients. Single-port ERSD using the Da Vinci SP platform is safe and feasible for the management of colorectal neoplasia, ensuring a high rate of en-bloc resection. It potentially offers advantages over conventional ESD, including shorter dissection times, although further studies are necessary for a definitive comparison.

Cardiovascular Outcomes after Paclitaxel-Coated Balloon Angioplasty versus Drug-Eluting Stent Placement for Acute Coronary Syndrome: A Systematic Review and Meta-Analysis.

Background: We conducted a systematic review and meta-analysis to examine the feasibility of paclitaxel-coated balloon (PCB) angioplasty for de novo lesions in patients with acute coronary syndrome (ACS) by comparing with drug-eluting stent (DES) placement. Methods: By a systematic literature search, nine (five randomized controlled, two retrospective propensity-score matched, and two retrospective baseline-balanced) studies comparing the midterm clinical and angiographic outcomes after PCB angioplasty and DES placement were included, yielding 974 and 1130 ACS cases in PCB and DES groups, respectively. Major adverse cardiac event (MACE) was defined as a composite of cardiac mortality (CM), all-cause mortality (ACM), myocardial infarction (MI), target vessel revascularization (TVR), and target lesion revascularization (TLR). Late luminal loss (LLL) and bleeding events (BLD) were also estimated. Results: The frequencies of MACE in PCB and DES groups were 8.42% and 10.62%, respectively. PCB angioplasty had no significant impacts on all of MACE (risk ratio: 0.90, 95%CI: 0.68-1.18, p = 0.44), CM, ACM, MI, TVR, TLR, BLD, and LLL, compared to DES placement in random-effects model. Conclusions: The present systematic review and meta-analysis showed the feasibility of PCB angioplasty for the de novo lesions in patients with ACS in comparison with DES placement by the emergent procedures.

Eventos hemorrágicos tardíos en pacientes de TAVI anticoagulados con antagonistas de la vitamina K o anticoagulantes orales de acción directa

Introduction and objectivesThe optimal chronic antithrombotic regimen for patients with atrial fibrillation undergoing transcatheter aortic valve implantation (TAVI) remains uncertain. Our aim was to compare the incidence of late bleeding events between patients on direct oral anticoagulants (DOACs) and those on vitamin-K antagonists (VKA). MethodsThis single-center observational study included TAVI patients requiring oral anticoagulation at discharge between 2015 and 2021. The primary endpoint was any clinically significant bleeding event. Secondary endpoints were stroke, heart failure, and all-cause mortality. ResultsA total of 702 TAVI procedures were performed, with 297 patients requiring oral anticoagulation at discharge. Among them, 206 (69.4%) received VKA and 91 (30.6%) received DOAC. Baseline clinical, procedural and in-hospital characteristics did not significantly differ between groups, except for better renal function among DOAC patients. The median length of follow-up was 2.8 years. The risk of bleeding events was higher in patients receiving DOACs than in those receiving VKA (HR, 2.27; 95%CI, 1.21-4.26; incidence of 9.7 and 4.2 events per 100 patient-years of follow-up for DOAC and VKA patients, respectively). There were no statistically significant differences in the rates of stroke (HR, 1.28; 95%CI, 0.4-4.3), heart failure hospitalization (HR, 0.92; 95%CI, 0.46-1.86), or all-cause mortality (HR, 1.02; 95%CI, 0.68-1.55). ConclusionsIn older patients undergoing TAVI and receiving anticoagulant therapy for atrial fibrillation, the use of DOAC was associated with a higher risk of late bleeding events than VKA.

Curative Effect Analysis of Endoscopic Submucosal Dissection in Giant Laterally Spreading Rectal Tumors.

The objective of this study was to investigate the clinical efficacy of endoscopic submucosal dissection (ESD) in the treatment of giant lateral developing rectal-type tumors (laterally spreading tumors, LSTs). There are no specialized studies on the efficacy of ESD in the treatment of LSTs measuring >5cm in diameter, surgery was often used in the past, but it has the disadvantages of large trauma, many complications, and high cost. The data of 185 patients with rectal LSTs who had undergone ESD in the digestive endoscopy center of our hospital from January 2012 to June 2020 were retrospectively analyzed. Based on the size of the lesions, the patients were divided into 2 groups: diameter ≤5cm (110 cases) and diameter >5cm (75 cases), and we summarized and analyzed the en bloc resection rate, curative resection rate, procedure time, muscle injury, bleeding, perforation, postoperative stricture, and recurrence. There was no difference in the en bloc resection rate and R0 resection rate between the 2 groups ( P =0.531). Moreover, there was no difference in the incidence of delayed perforation, postoperative stenosis, and recurrence, but the incidence of delayed bleeding was significantly higher in the giant LST group than the small LST group ( P =0.001). Moreover, for giant rectal LSTs, the growth pattern of the lesion, JNET classification, and the extent of postoperative mucosal defect do not significantly affect the efficacy of ESD. It is worth mentioning that the operation time was longer in the group with a diameter >5cm, in which perforation was more frequent and the muscle layer was more likely to be injured during ESD ( P <0.001). The muscle injury during ESD was mainly related to the diameter of the lesion, the crossing the rectal pouch, and the operation time. The use of ESD to treat giant rectal LSTs (>5cm) is relatively difficult and can easily lead to intraoperative muscle injury, perforation, and late postoperative bleeding. However, if active intervention is performed, patients can still achieve good efficacy and prognosis, which can be applied in hospitals with certain conditions.

Impact of center volume on outcomes after ventricular assist device implantation in pediatric patients: An analysis of the STS-Pedimacs database

To date, no pediatric studies have highlighted the impact of center's ventricular assist device (VAD) volumes on postimplant outcomes. Children (age <19) enrolled in Pedimacs undergoing initial left ventricular assist device implantation from 2012 to 2020 were included. Center volume was analyzed as a continuous and categorical variable. For categorical analysis, center volumes were divided as: low volume (1-15 implants), medium volume (15-30 implants), and high volume (>30 implants) during our study period. Patient characteristics and outcomes were compared by center's VAD volumes. Of 44 centers, 16 (36.4%) were low, 11 (25%) weremedium, and 17 (38.6%) werehigh-volume centers. Children at high-volume centers were least likely intubated, sedated, or paralyzed, and most likely ambulating preimplant (p<0.05 for all). Center's VAD volumes were not a significant risk factor for mortality postimplant when treated as a continuous or a categorical variable (p>0.05). Compared to low volume, children at high-volume centers had fewer early neurological events. Compared to medium volume, those at high-volume centers had fewer late bleeding events(p<0.05 for all). There were no significant differences in survival after an adverse event by hospital volumes (p>0.05). Althoughhospital volume does not affect post-VAD implant mortality, pediatric centers with higher VAD volumes have fewer patients intubated, sedated, paralyzed preimplant, and have lower adverse events. Failure to rescue was not significantly different between low, medium, and high-volume VAD centers.

Impact of prostate position-based image-guidance in intensity-modulated radiation therapy for localized prostate cancer.

The long-term clinical impact of prostate position-based image-guided radiotherapy (IGRT) for localized prostate cancer remains unclear. We retrospectively compared clinical outcomes following intensity-modulated radiation therapy (IMRT) with cone-beam computed tomography-based prostate position-based IGRT (P-IGRT) or without P-IGRT (non-P-IGRT). From June 2011, we applied P-IGRT in IMRT for intermediate-risk (IR) prostate cancer (PCa) (D'Amico risk classification) (76Gy in 38 fractions, with smaller margins). Clinical outcomes of patients who received P-IGRT between June 2011 and June 2019 were retrospectively compared with those of patients with IR PCa who received IMRT without P-IGRT between October 2002 and May 2011 in our institution (74Gy in 37 fractions). A total of 222 consecutive patients were analyzed: 114 in the P-IGRT cohort and 108 in the non-P-IGRT cohort. The median follow-up period after IMRT was 7.1years for the P-IGRT cohort and 10.8years for the non-P-IGRT cohort. The biochemical failure-free rate was significantly better in the P-IGRT cohort (94.9% for the P-IGRT cohort vs 82.7% for the non-P-IGRT cohort at 10years, p = 0.041). The rate of rectal bleeding which needs intervention including the use of suppositories was significantly lower in the P-IGRT cohort (p < 0.001). The use of P-IGRT with higher doses and smaller margins was correlated with significantly better biochemical control, and a lower incidence of rectal bleeding in IMRT for intermediate-risk prostate cancer. The enhanced accuracy using P-IGRT has the potential to independently improve disease control and reduce late rectal bleeding.

Risk factors for late postoperative bleeding after partial glossectomy for tongue cancer

Background Partial glossectomy is the most common procedure for early-stage tongue cancer. Although late postoperative bleeding occasionally occurs, the associated risk factors have not been adequately identified. Aims/objectives We aimed to investigate the rate and risk factors for late postoperative bleeding after transoral partial glossectomy with or without neck dissection for tongue cancer at our institution. Material and methods We analysed 211 patients who had undergone transoral partial glossectomy between January 2016 and January 2023. The potential risk factors associated with late postoperative bleeding were investigated using univariate and multivariate logistic regression analyses. Results Of the 211 patients, 40 (19%) showed late postoperative bleeding, with 19 (9%) classified as grade IIIa (Clavien-Dindo classification). Regarding all grades, late postoperative bleeding was significantly higher in patients aged <70 years and in those with polyglycolic acid (PGA) sheets (p = .046 and .030, respectively). For grade ≥ IIIa, late postoperative bleeding was significantly higher in patients with a history of anticoagulant/platelet administration, a mucosal defect covered with fibrin glue and a PGA sheet (p = .045 and .026, respectively). Conclusions and significance The findings of this study suggest that primary closure decreases the frequency of late postoperative bleeding.

Assessment of a therapeutic protocol for the management of snakebite envenomations in Benin

Snakebite envenomation is a major public health issue in Sub-Saharan Africa (SSA). Antivenoms are the only etiological treatment. However, the dose recommended by the manufacturer (2 vials renewed every 2 hours in case of persistent bleeding) is usually not applied due to the high cost which is borne only by the patient. Based on clinical presentation, we evaluated the administration of a single vial on admission (instead of 2 vials), which corresponds to the therapeutic protocol used in current practice in most health centers in Benin and beyond in SSA. Renewal of antivenom followed manufacturer's recommendation. The study took place in a first referral hospital in Tanguiéta, North Benin. All envenomed patients received a slow intravenous vial of Inoserp® Pan-Africa (IPA) upon arrival. A clinical assessment identical to that of inclusion was carried out 2, 4, 6, 12 and 24 hours later to assess the tolerance and efficacy of the IPA, as well as the need to readminister the antivenom. The occurrence, persistence or worsening of clinical hemorrhages or neurological disorders, the latter reflecting envenomation by elapids, systematically led to the injection of 2 or 4 vials of IPA, respectively. Signs of intolerance were sought before and after each administration of antivenom, then 2 weeks to 1 month after treatment, in order to estimate the incidence of adverse effects attributable to the antivenom. Efficacy of IPA was assessed by cessation of bleeding and/or normalization of whole blood coagulation test (WBCT) within 24 hours of initial administration. The study took place from July 31 to October 31, 2019. We received 53 cases of snakebites of which 43 were included. The median age was 21 [IQR: 18-31] years and the sex ratio (M/F) was 1.5. Farmers were the majority (48%). The median time to admission was 1 [IQR: 0-2] day. On admission, 32 patients (74%) presented hemostasis disorders marked by bleeding and/or abnormal WBCT. None of the patients showed neurological symptoms. The median time to normalization of WBCT was 24 [IQR: 4-72] hours. The median time to stop bleeding was 6 [IQR: 4-12] hours. In 3 of the 11 patients whose bleeding had stopped at H2, a recurrence occurred within the following 24 hours. In addition, 3 patients presented with late bleeding 24 hours after admission. Two patients (5%) died as a result of envenomation. The simplified protocol represents a significant saving in the number of vials used, i.e. 1.8±0.4 vials per patient instead of the 2.4±0.2 which would have been necessary in these same patients treated according to the standard protocol (p = 2.6·10-4). However, in comparison with the results obtained during the previous clinical study, the cessation of bleeding is delayed, as is the normalization of the WBCT at the different follow-up times. In addition, the number of re-administrations of antivenom after H2 is higher in the light protocol than in the standard one, respectively 13 patients out of 43 treated versus 4 patients out of 59 (p = 0.006). There was no significant difference between the incidence of signs of early antivenom intolerance in this study compared to the previous one (16% and 11%, respectively; p = 0.79). This delay can put up to a third of patients at risk of complications. Despite its effectiveness and the antivenom savings made, it does not seem reasonable to recommend it.

Endorobotic submucosal dissection of rectal lesions using the single port robot DaVinci-SP: initial experience of the first 10 cases.

Endoluminal surgery is increasingly recognized as a mode of treatment for colorectal neoplasms with the latest robotic single port platform Da Vinci-SP (Intuitive Surgical, Sunnyvale) facilitating submucosal dissection of benign rectal neoplasm. In this study, we present our initial experience with endorobotic submucosal dissection in the management of benign rectal neoplasms using the Da Vinci-SP (Intuitive Surgical, Sunnyvale) between 2020 and 2021. The primary endpoint was the successful completion of submucosal dissection. During the study period, 10 patients underwent endorobotic submucosal dissection for benign rectal neoplasms. The median age of the patients was 68 (range: 59-78) years, and the mean BMI was 29.38 (range: 22.9-38.5). The mean size of the lesion was 42.3 mm (range: 20-65 mm) and was located 7.3 cm (mean) from the anal verge (range: 2-10 cm). The mean operative time was 91.3 minutes (range: 57-137 minutes). All 10 dissections were completed successfully en bloc. There were no intraoperative complications or mortality. All patients were discharged on the same day and commenced on a normal diet. Late bleeding was observed in one patient receiving anticoagulation, and one patient had urinary retention. Pathology revealed two adenocarcinomas, six tubulovillous adenomas, one tubular adenoma, and one sessile serrated adenoma. There was no recurrence in all other patients during the median follow-up of 6 months (range: 4-16 months). Endorobotic submucosal dissection using a single-port robotic platform is safe and feasible for benign rectal mucosal neoplasms. The semiflexible platform offers an alternative to endoscopic submucosal dissection with favourable outcomes.

Colonoscopic polypectomy of juvenile polyps in children: Experience from a tertiary centre of Bangladesh

AimsTo assess the specifics of juvenile polyps and the value of polypectomy with complete colonoscopy in pediatric patients. MethodsI retrospectively reviewed the medical records of 81 children diagnosed with juvenile polyps from 2017 to 2021. ResultsThe patients' ages ranged from 1.5 to 18 years. Hematochezia was present in 100% of cases, in which 97.5% of the bleeding was painless. The most frequent was red or dark red hematochezia in 71.6% of cases, followed by red stool with blood dripping in 9 (11.1%) cases. The time interval between the first episode of hematochezia and the colonoscopy ranged from 1 to 47 months. Only 24.7% of polyps were diagnosed by digital rectal examination. Most of the Juvenile polyps were solitary (82.8%) and located in the rectosigmoid part of the colon. The size of the polyps varied from 0.3 to 4 ​cm. Early post-polypectomy bleeding occurred in two cases, while late post-polypectomy bleeding occurred in only one case. ConclusionsAlthough solitary juvenile polyps in the rectosigmoid colon are more common, some patients had multiple and some had proximal polyps. Therefore, a colonoscopy of the entire colon with therapeutic polypectomy is important for improved outcomes when evaluating painless, intermittent hematochezia in children.

Onset Time and Characteristics of Postprocedural Bleeding after Endoscopic Resection of Colorectal Lesions: A Multicenter Retrospective Study

Introduction: Postprocedural bleeding is a major adverse event after endoscopic resection of colorectal lesions, but the optimal surveillance time after endoscopy is unclear. In this study, we determined onset time and characteristics of postprocedural bleeding events. Methods: We retrospectively screened patients who underwent endoscopic resection of colorectal lesions at three German hospitals between 2010 and 2019 for postprocedural bleeding events using billing codes. Only patients who required re-endoscopy were included for analysis. For identified patients, we collected demographic data, clinical courses, characteristics of colorectal lesions, and procedure-related variables. Factors associated with late-onset bleeding were determined by univariate and multivariate logistic regression analysis. Results: From a total of 6,820 patients with eligible billing codes, we identified 113 cases with postprocedural bleeding after endoscopic mucosal (61.9%) or snare resection (38.1%) that required re-endoscopy. The median size of the culprit lesion was 20 mm (interquartile range 14–30 mm). The median onset time of postprocedural bleeding was day 3 (interquartile range: 1–6.5 days), with 48.7% of events occurring within 48 h. Multivariate logistic regression analysis demonstrates that a continued intake of antiplatelet drugs (OR: 3.98, 95% CI: 0.89–10.12, p = 0.025) and a flat morphology of the colorectal lesion (OR: 2.98, 95% CI: 1.08–8.01, p = 0.031) were associated with an increased risk for late postprocedural bleeding (>48 h), whereas intraprocedural bleeding was associated with a decreased risk (OR: 0.12, 95% CI: 0.04–0.50, p = 0.001). Conclusion: Significant postprocedural bleeding can occur up to 18 days after endoscopic resection of colorectal lesions, but was predominantly observed within 48 h. Continued intake of antiplatelet drugs and a flat polyp morphology are associated with risk for late postprocedural bleeding.

Effect of Daikenchuto Therapy on Risk of Rectal Bleeding after IMRT for Prostate Cancer

Rectal bleeding due to radiation proctitis after treatment in radiation therapy for prostate cancer is a typical late toxicity symptom. The rate of rectal bleeding has been reduced by using IMRT, IGRT and peri-rectal hydrogel spacer. On the other hand, few reports have attempted to reduce the rate of rectal bleeding by medication. It has been reported that Daikenchuto (DKT), a traditional Japanese herbal medicine, has the effects of accelerating gastrointestinal motility and anti-fibrosis. We retrospectively investigated the rate of rectal bleeding in patients between concurrently administered and not administered DKT for bowel control during IMRT for prostate cancer. The subjects were 102 patients who underwent definitive IMRT for prostate cancer between 2014 and 2021 in our hospital. The DKT therapy concurrent use group were included 46 patients (45%), who were administered DKT per 10.0 g / day or 15.0 g / day. The irradiation was carried out, confirming the rectal volume every time by the image-guided radiotherapy using cone beam CT in all cases. The curative doses fractionation of IMRT were 78 Gy in 2 Gy per fraction (40%) or 70 Gy in 2.5 Gy per fraction (60%). We compared the rate of rectal bleeding after IMRT with and without DKT. Late rectal bleeding toxicity was scored using the Common Terminology Criteria for Adverse Events ver. 5.0 criteria. The associated factors of rectal bleeding were examined using the Cox proportional hazard model for multivariate analysis. In the DKT therapy group, the median follow-up period was 31 months (Range: 17-84 months), and the rectal bleeding rate was Grade 1 in 2 patients (4%) and Grade ≥ 2 in none. The median observation period in the non-DKT therapy group was 48 months (Range: 17-101 months), and the rectal bleeding rate was Grade 1 in 12 patients (21%), Grade 2 in 6 patients (10%), and there were no events of Grade ≥ 3. In univariate analysis, DKT therapy, dose fractionation and planned rectal doses (V50, V55, V60, V65, V70 and V75 converted to EQD23) were significant factors for rectal bleeding. Multivariate analysis showed that the DKT therapy was a significant independent factor in reducing the rate of rectal bleeding (HR: 0.105, 95% CI: 0.01-0.50, P = 0.003). It was statistically suggested in this study that the DKT therapy further reduced the rate of rectal bleeding in IMRT for prostate cancer.

Hypofractionated Radiotherapy for Prostate Cancer (HRT20) Trial: Results

Radiotherapy is a definitive standard treatment for men with localized prostate cancer. Improvements in technology allow higher doses of radiation delivered to the prostate in less days, with lower doses to surrounding healthy tissues trying to reduce side effects. Several studies demonstrated that hypofractionated radiotherapy of 60 Gy is non-inferior to conventional radiotherapy fractionation. To report the first results in toxicity and biochemical relapse free survival of HRT20 trial after 5 years of recruitment. The HRT20 trial is registered (NCT03851926). A prospective observational study enrolled 298 men with localized prostate cancer (pT1b-T3aN0M0) started in October 2016. Median age was 75 (53-91). Median PSA was 14.5ng/ml. Using NCCN classification: 12,6% were low risk, 50.5% were intermediate and 36.9 % were high risk patients. The median duration of the treatment was 30 days (23-41) The clinical target volume (CTV) consisted of the prostate and seminal vesicles when affected. The CTV-planning target volume (PTV) margin was 0.8 cm. The primary end point evaluated assessed by CTCAE 4.0 was related later adverse events and the second end point was biochemical relapse free survival by Phoenix definition. WMAT plans calculations were carried out using the Monaco TPS version 5.10 based on a single arc arrangement. Univariate and multivariate logistic analyses were carried out. After median follow up of 56 months. The 5-year incidence rates of grade 2 and 3 late gastrointestinal toxicities were 6.3% and 3.1%, respectively, and those of grade 2 and 3 late genitourinary toxicities were 7.9% and 1%, respectively. PTV volume was found to be correlated with late rectal bleeding (p = 0.02). Also, urinary tract obstruction was correlated with PTV volume. The proportion of patients who were biochemical failure free at 5 years was 88·3% (95% CI 86·0-90·2) Multivariate analysis indicated that risk stage (p = 0.03) and number of positive needles biopsy cores (p = 0.02) were prognostic factor for biochemical relapse-free survival rates. The findings of this study indicate that hypofractionated is well tolerated and it is associated with good 5-years tumor-control outcomes in patients with localized prostate cancer. Long-term follow-up continues.

Late Bleeding Events in Patients Undergoing Percutaneous Coronary Intervention in the Workup Pre-TAVR

BackgroundIn patients undergoing percutaneous coronary intervention (PCI) in the work-up pre–transcatheter aortic valve replacement (TAVR), the incidence and clinical impact of late bleeding events (LBEs) remain largely unknown. ObjectivesThis study sought to determine the incidence, clinical characteristics, associated factors, and outcomes of LBEs in patients undergoing PCI in the work-up pre-TAVR. MethodsThis was a multicenter study including 1,457 consecutive patients (mean age 81 ± 7 years; 41.5% women) who underwent TAVR and survived beyond 30 days. LBEs (>30 days post-TAVR) were defined according to the Valve Academic Research Consortium-2 criteria. ResultsLBEs occurred in 116 (7.9%) patients after a median follow-up of 23 (IQR: 12-40) months. Late bleeding was minor, major, and life-threatening or disabling in 21 (18.1%), 63 (54.3%), and 32 (27.6%) patients, respectively. Periprocedural (<30 days post-TAVR) major bleeding and the combination of antiplatelet and anticoagulation therapy at discharge were independent factors associated with LBEs (P ≤ 0.02 for all). LBEs conveyed an increased mortality risk at 4-year follow-up compared with no bleeding (43.9% vs 36.0; P = 0.034). Also, LBE was identified as an independent predictor of all-cause mortality after TAVR (HR: 1.39; 95% CI: 1.05-1.83; P = 0.020). ConclusionsIn TAVR candidates with concomitant significant coronary artery disease requiring percutaneous treatment, LBEs after TAVR were frequent and associated with increased mortality. Combining antiplatelet and anticoagulation regimens and the occurrence of periprocedural bleeding determined an increased risk of LBEs. Preventive strategies should be pursued for preventing late bleeding after TAVR, and further studies are needed to provide more solid evidence on the most safe and effective antithrombotic regimen post-TAVR in this challenging group of patients.

Incidence, Predictors, and Prognostic Impact of Bleeding Events After TAVR According to VARC-3 Criteria

BackgroundThe updated Valve Academic Research Consortium (VARC) definition for bleeding events after transcatheter aortic valve replacement (TAVR) lacks of clinical validation. ObjectivesThe aim of this study was to determine the incidence, predictors, and clinical impact of bleeding events following TAVR as defined by recent VARC-3 criteria. MethodsA total of 2,384 consecutive patients with severe symptomatic aortic stenosis undergoing TAVR were included. Early (at index hospitalization) and late (after hospital discharge) bleeding complications were defined according to VARC-3 criteria as type 1, 2, 3, or 4. Baseline, procedural, and follow-up (24 [IQR: 12-43] months) data were prospectively collected. ResultsBleeding events occurred in 761 patients (31.9%): types 1, 2, 3, and 4 in 169 (22.2%), 399 (52.4%), 149 (19.6%), and 44 (5.8%) patients, respectively. The primary vascular access site and gastrointestinal locations were the most common bleeding sources among early and late bleeding events, respectively. Female sex, thoracotomy access, larger (14-F) sheath use, and dual antiplatelet therapy determined an increased risk of early bleeding events (P < 0.02 for all). The use of the radial artery for secondary access was associated with a significant risk reduction of early bleeding (P < 0.001). Type 2 and type 3 events were associated with an increased mortality risk at 30-day (HR: 2.94 [95% CI: 1.43-6.03; P = 0.003] and HR: 4.91 [95% CI: 2.19-11.03; P < 0.001], respectively) and 1-year (HR: 1.86 [95% CI: 1.28-2.69; P = 0.001] and HR: 2.28 [95% CI: 1.41-3.66; P = 0.001], respectively) follow-up. A similar prognostic pattern was observed when applying VARC-2 criteria but with a much lower global incidence of early bleeding events (19% vs 27%; P < 0.001). ConclusionsBleeding events after TAVR were associated with poorer short- and long-term survival. The magnitude of this correlation was proportional to bleeding severity defined according to VARC-3 criteria. Further studies on bleeding prevention following TAVR are warranted to improve procedural safety and patient prognosis.