SUMMARY Gastric juice from patients with peptic ulcer disease and from patients with no upper gastrointestinal abnormality was studied in order to assess its effect on a formed fibrin clot. In both groups of patients gastric juice caused a marked increase in fibrinolysis as evidenced by a shortening of the euglobulin clot lysis time. This plasmin mediated fibrinolytic activity was found to be heat labile and only present in an acid environment. Addition of tranexamic acid or sucralfate to gastric juice almost completely reversed this effect, whereas pepstatin was only partially effective. It is probable that acid dependant proteases other than pepsin are responsible for the marked fibrinolysis. The ulcer healing agent sucralfate might be useful in those patients at risk of bleeding or rebleeding from active peptic ulcer disease.Haemorrhage from active peptic ulcer disease remains a common and difficult therapeutic problem. Despite many new approaches in management, the mortality has changed little over the past 50 years. Approximately 10% of patients with acute upper gastrointestinal bleeding will die' and the mortality rate may rise to over 30% in that subgroup requiring emergency surgery."Th4 poor haemostatic response seen in the bleeding upper gastrointestinal tract has been variously ascribed to increased gastrointestinal motility during haemorrhage,' the marked vascularity and absence of autoregulation of local blood flow,' and the adverse effects of both acid and pepsin on the coagulation cascade.7 Moreover, dissolution of a formed fibrin clot is thought to be responsible for the very high incidence of rebleeding observed. Several investigators have identified fibrinolytic activity in gastric venous blood of patients with gastric haemorrhage`" and in gastric juice of patients with erosive gastroduodenitis."`R ecent work has suggested a beneficial effect of specific antifibrinolytic agents in preventing rebleeding in acute upper gastrointestinal haemorrhage."'" In the present study we have assessed the degree of fibriAddress for correspondencec: D P O'Donoghue,

Purpose: To evaluate the effectiveness of radiofrequency (RF) ablation as measured by change in worst pain score from baseline to 3 mo after RF ablation for the palliative treatment of painful bone metastases.Materials and Methods: One hundred patients (mean age, 64.6 y) underwent RF ablation for metastatic bone disease and were followed up to 6 mo. Subjects' pain and quality of life were measured before RF ablation and postoperatively by using the Brief Pain Index and European Quality of Life questionnaires. Opioid agent use and device-, procedure-, and/or therapy-related adverse events (AEs) were collected.Results: Eighty-seven patients were treated for tumors involving the thoracolumbar spine and 13 for tumors located in the pelvis and/or sacrum. All ablations were technically successful, and 97% were followed by cementoplasty. Mean worst pain score decreased from 8.2 ± 1.7 at baseline to 3.5 ± 3.2 at 6 mo (n ¼ 22; P < 0.0001 for all visits). Subjects experienced significant improvement for all visits in average pain (P <.0001), pain interference (P < .0001), and quality of life (P < .003). Four AEs were reported, of which 2 resulted in hospitalization for pneumonia and respiratory failure. All 30 deaths reported during the study were attributed to the underlying malignancy and not related to the study procedure.Conclusions: Results from this study show rapid (within 3 d) and statistically significant pain improvement with sustained long-term relief through 6 mo in patients treated with RF ablation for metastatic bone disease.

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A bleeding patient is a common consult for interventional radiologists. Prompt triage, preprocedural evaluation specific to the site of hemorrhage, and knowledge of resuscitative strategies allow for a potentially life-saving procedure to be appropriately and safely performed. Having a firm understanding of the clinical work-up and management of a bleeding patient has never been more important. In this article, a discussion of the clinical approach and work-up of a bleeding patient for whom interventional radiology is consulted is followed by a discussion of etiology-specific preprocedural work-up.

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12086 Background: Patients with bone metastases may experience pain and decreased quality of life. Standard of care therapies such as radiation therapy could take weeks for pain relief and carry a risk of radiation induced fracture. Minimally invasive percutaneous radiofrequency ablation (RFA) have been shown in small observational studies to be an alternative treatment for bone metastases. We report the results of the OPuS One trial evaluating RFA for the palliative treatment of patients with painful bone metastases. Methods: OPuS One (NCT03249584) was a multicenter prospective trial. 218 subjects with painful bone metastases (≥ 4/10 worst pain scores, Brief Pain Inventory [BPI], at target treated site) were enrolled from 15 sites. RFA was performed under image guidance at one or two locations. Vertebral augmentation was followed based on physician’s discretion. Subjects’ pain (BPI) and quality of life (EQ-5D) scores were calculated in subjects at three days, one week, and one, three, six, and 12 months post RFA. Rate of complete (0 pain score at treated site with no concomitant analgesic increase) and partial responders (≥ 2 pain score reduction without analgesic increase or analgesic reduction of ≥ 25% from baseline) were calculated. Device-, procedure-, and/or therapy-related adverse events (AEs) were collected. Results: 206 subjects, 113 (55%) female and 93 (45%) males (mean age was 63.7 years) were treated with RFA. Most common primary cancers were breast (23%), lung (23%), and kidney (10%). 184 (89%) subjects were treated for metastatic lesions involving the thoracolumbar spine and 22 (11%) subjects were treated for iliac crest, periacetabulum, sacrum or mixed vertebral and pelvic location. 99% (262/264) of RFA procedures were technically successful and 97% were followed by vertebral augmentation. Subjects reported significant improvement in worst pain from baseline at 7.8 to 5.5, 4.7, 3.6, 3.2, 2.4, and 2.6 at three days, one week and one, three, six, and 12 months post RFA, respectively (p < 0.0001 for all visits). Significant improvements were also seen in average pain (p < 0.0001 for all visits), pain interference (p < 0.0001 for all visits), and quality of life scores (p < 0.0001 for all visits). Overall response rates were 53%, 58%, 61%, 63%, 70%, and 75% at three days, one week, one month, three months, six months, and twelve months post RFA, respectively. Six AEs were reported with three as serious: intra-abdominal fluid collection, pneumonia and respiratory failure. 82 deaths were reported during the study, none were related to the device, therapy, and/or procedure. No skeletal related events were reported. Conclusions: In a large prospective multicenter trial, OPuS One, RFA provided rapid, significant, and durable improvements in pain relief and quality of life up to 12 months. Clinical trial information: NCT03249584.

Purpose The OsteoCool Tumor Ablation Post-Market Study (OPuS One) was a prospective, multi-national, single-arm study to investigate safety and effectiveness of radiofrequency ablation (RFA) for palliation of painful lytic bone metastases with 12 months of follow-up. RFA has demonstrated effective palliation of osseous metastases in small clinical studies with short-term follow-up; however, a long-term assessment with robust subject numbers is lacking. Materials and Methods Prospective assessments were conducted at Baseline, 3 days, 1 week, and 1, 3, 6, and 12-months. Pain and quality of life were measured prior to RFA and postoperatively using the Brief Pain Inventory, European Quality of Life—5 Dimension, and European Organization for Research and Treatment of Cancer Care Quality of Life Questionnaire for palliative care. Radiation, chemotherapy and opioid usage, and related adverse events were collected. Results 206 subjects were treated with RFA at 15 institutions in OPuS One. Worst pain, average pain, pain interference and quality of life significantly improved at all visits starting 3 days post-RFA and sustained to 12 months (P < 0.0001). Post hoc analysis found neither systemic chemotherapy nor local radiation therapy at the index site of RFA influenced worst pain, average pain, or pain interference. Six subjects had device/procedure-related adverse events. Conclusion RFA for lytic metastases provides rapid (within 3 days) and statistically significant pain and quality of life improvements with sustained long-term relief through 12 months and a high degree of safety, independent of radiation. Level of Evidence: 2b, Prospective, Non-Randomized, Post-Market study This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.