International Registry Of Patients Research Articles

Discussion on contents and methods of quality control for acupuncture registry study

To explore the basic principles and methods of quality control of clinical registry research in the field of acupuncture. This study drawed on the data quality control methods of clinical trials in the United States and combined clinical practice experience, based on the "International Patient Registry Platform of Acupuncture and Moxibustion", and the registry study of acupuncture treatment for early-onset ovarian insufficiency as a model. The principles of accuracy, authenticity, consistency and completeness were followed. A remote and on-site quality control method with remote quality control as the main and on-site quality control as the supplement is formed, with a view to providing ideas and reference for the quality control of registry research.

Abstract 213: A Comparison of Patient Profiles and 1-year Health Status Outcomes Following a Diagnosis of Peripheral Artery Disease in Two High-income Countries: Insights From the Portrait Registry

Background: Peripheral artery disease (PAD) prevalence is increasing by age in high-income countries. It is unknown whether patient characteristics, treatment profiles, and 1-year PAD-specific health status outcomes differ across health care contexts in high-income countries such as the ones in the United States (US) vs. the Netherlands. Methods: Patients were identified from the Patient-centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT) study which is a prospective, multicenter, international registry of patients presenting to vascular specialty clinics for new onset, or an exacerbation of PAD symptoms. PAD-specific health status was measured by Peripheral Artery Questionnaire (PAQ) at presentation, and at 3, 6 and 12 months follow-up using adjusted generalized repeated measurement models. Results: Out of a total of 1,114 patients,748 patients (67.1%) were from the US and 366 (32.9%) were from the Netherlands. US patients with PAD were significantly older and had a higher cardiovascular risk factor burden including smoking (Table) with more Netherlands patients being referred to supervised vs. unsupervised exercise therapy (SET) as compared with the US cohort after enrollment. US patients presented with significantly lower PAD-specific health status scores (PAQ summary scores) upon presentation (-41.59 vs 49.58, p<0.0001) as well as at 12 months following their vascular work-up (61.05 vs 74.66, p<0.0001). US patients also had lower rates of improvement that consistently lagged behind the Netherlands at all time points (p<0.001). The interaction between country*time was significant at all time points. Conclusion: US patients seeking care for PAD have a different risk profile upon presentation from Dutch patients, including worse health status profiles, and had less exposure to SET. Even after adjustment, worse PAD-specific health status outcomes were seen in the US cohort at baseline throughout 12 months of follow-up. Contrasting risk exposure patterns and health care systems across high-income care settings may highlight mutual learning opportunities to advance the care for PAD.

Incident heart failure in outpatients with chronic coronary syndrome: results from the international prospective CLARIFY registry.

The contemporary incidence of heart failure (HF) in patients with chronic coronary syndrome is unclear. We aimed to study the incidence and predictors of cardiovascular (CV) death, HF hospitalization or new-onset HF not requiring hospitalization, in patients included in the CLARIFY registry. CLARIFY is a contemporary, international registry of ambulatory patients with chronic coronary artery disease, conducted in 45 countries. At baseline, data on demographics, ethnicity, CV risk factors, medical history, cardiac parameters and medication were collected. Patients were followed up yearly up to 5 years. In this analysis, 26 769 patients with no HF history were included. At 5-year follow-up, 4393 patients (16.4%) reached the primary endpoint comprising CV death, HF hospitalization, or new-onset HF. Only 16.7% of them (n=732) required hospitalization for HF. All-cause death occurred in 6.6% of patients (61.4% were CV). Age over 70 years, left ventricular ejection fraction <50%, Canadian Cardiovascular Society class ≥2 angina, atrial fibrillation or paced rhythm on the ECG, body mass index <20 kg/m2 , and a history of stroke, were the most robust predictors of the primary outcome. Age <50 years, Asian ethnicity, and percutaneous revascularization were negative predictors of the outcome. A sizeable proportion of patients with chronic coronary syndrome develop HF, which only infrequently requires hospitalization. Early identification of patients with HF may lead to early treatment, and help to further decrease mortality and morbidity. This concept needs confirmation in future studies.

The Alopecia Areata Consensus of Experts (ACE) study: Results of an international expert opinion on treatments for alopecia areata

A systematic review failed to identify any systemic therapy used in alopecia areata (AA) where use is supported by robust evidence from high-quality randomized controlled trials. To produce an international consensus statement on the use and utility of various treatments for AA. Fifty hair experts from 5 continents were invited to participate in a 3-round Delphi process. Agreement of 66% or greater was considered consensus. In the first round, consensus was achieved in 22 of 423 (5%) questions. After a face-to-face meeting in round 3, overall, consensus was achieved for only 130 (33%) treatment-specific questions. There was greater consensus for intralesional treatment of AA (19 [68%]) followed by topical treatment (25 [43%]). Consensus was achieved in 45 (36%) questions pertaining to systemic therapies in AA. The categories with the least consensus were phototherapy and nonprescription therapies. The study included a comprehensive list of systemic treatments for AA but not all treatments used. Despite divergent opinions among experts, consensus was achieved on a number of pertinentquestions. The concluding statement also highlights areas where expert consensus is lacking andwhere an international patient registry could enable further research.

Thirty-day outcomes in patients with proximal deep vein thrombosis who discontinued anticoagulant therapy prematurely

IntroductionIn patients receiving anticoagulation for deep vein thrombosis (DVT), a variety of reasons (including active bleeding or high-risk for bleeding) may lead into premature discontinuation of therapy (prior to completing 90 days). The relative frequency and clinical consequences of premature discontinuation in contemporary patients remain unknown. MethodsWe used the data from RIETE, an international registry of patients with venous thromboembolism (VTE), to identify patients with proximal (above knee) lower limb DVT who prematurely discontinued anticoagulation. We assessed the incidence of the composite outcome: pulmonary embolism (PE)-related death, sudden death, or recurrent VTE within the subsequent 30 days after discontinuation and compared the risk of these events vs. the risk in patients without premature discontinuation, once adjusted for demographics and clinical factors. ResultsOf 26,335 patients with proximal DVT recruited from 2001 to 2018, 1322 (5.02%) prematurely discontinued anticoagulation. Thirty days after discontinuation, 12 (0.91%) patients suffered fatal PE (n = 8) or sudden death (n = 4) and 33 (2.50%) had non-fatal recurrent VTE (PE = 15; recurrent DVT = 18). In patients with premature discontinuation, the 30-day incidence of the composite outcome was 1.62 per 1000 patient-days (95%CI: 0.00–3.80). During the first week after discontinuation, the incidence rate was 4.09 per 1000 patient-days (95%CI: 0.65–7.52). The adjusted odds of the composite outcome was 7.88 times (95%CI: 6.39–9.72) higher in patients who discontinued prematurely than in those without premature discontinuation. ConclusionPremature discontinuation of anticoagulation occurred in 5% of patients with proximal DVT, and was associated an 8-fold increased odds for the composite outcome.

The Impact of Inherited Retinal Diseases in the Republic of Ireland (ROI) and the United Kingdom (UK) from a Cost-of-Illness Perspective.

To date, there has been a global lack of data regarding the prevalence of conditions falling under the Inherited Retinal Diseases (IRD) classification, the impact on the individuals and families affected, and the cost burden to economies. The absence of an international patient registry, and equitable access to genetic testing, compounds this matter. The resulting incomplete knowledge of the impact of IRDs hinders the development and commissioning of clinical services, provision of treatments, and planning and implementation of clinical trials. Thus, there is a need for stronger evidence to support value for money to regulatory bodies for treatments approved, and progressing through clinical trials. To ensure a strategic approach to future research and service provision, it is necessary to learn more about the IRD landscape. This review highlights two recent cost-of-illness reports on the socio-economic impact of 10 IRDs in the Republic of Ireland (ROI) and the United Kingdom (UK), which demonstrate the comprehensive impact of IRDs on individuals affected, their families, friends and society. Total costs attributable to IRDs in the ROI were estimated to be £42.6 million in 2019, comprising economic (£28.8 million) and wellbeing costs (£13.8 million). Wellbeing costs were estimated using the World Health Organization (WHO) burden of disease methodology, a non-financial approach, where pain, suffering and premature mortality are measured in terms of disability-adjusted-life-years (DALYs). In the UK, wellbeing costs attributable to IRDs were £196.1 million, and economic costs were £327.2 million amounting to £523.3 million total costs in 2019. Accounting for over one-third of total costs, the wellbeing burden of persons affected by IRDs should be emphasized and factored into reimbursement processes for therapies and care pathways. This targeted review presents the most current and relevant data on IRD prevalence in the ROI and the UK, and the impacts (financial and non-financial) of IRDs in terms of diagnosis, wellbeing, employment, formal and informal care, health system costs, deadweight losses and issues surrounding payers and reimbursement. This review demonstrates IRD patients and their families have common issues including, the need for timely equitable access to genetic testing and counselling, equality in accessing employment, and a revision of the assessment process for reimbursement of therapies currently focused on the cost-of-illness to the healthcare system. This review reveals that IRD patients do not frequently engage the healthcare system and as such suggests a cost-of-illness model from a societal perspective may be a better format.

Cardiovascular magnetic resonance in immune checkpoint inhibitor-associated myocarditis.

Myocarditis is a potentially fatal complication of immune checkpoint inhibitors (ICI). Sparse data exist on the use of cardiovascular magnetic resonance (CMR) in ICI-associated myocarditis. In this study, the CMR characteristics and the association between CMR features and cardiovascular events among patients with ICI-associated myocarditis are presented. From an international registry of patients with ICI-associated myocarditis, clinical, CMR, and histopathological findings were collected. Major adverse cardiovascular events (MACE) were a composite of cardiovascular death, cardiogenic shock, cardiac arrest, and complete heart block. In 103 patients diagnosed with ICI-associated myocarditis who had a CMR, the mean left ventricular ejection fraction (LVEF) was 50%, and 61% of patients had an LVEF ≥50%. Late gadolinium enhancement (LGE) was present in 48% overall, 55% of the reduced EF, and 43% of the preserved EF cohort. Elevated T2-weighted short tau inversion recovery (STIR) was present in 28% overall, 30% of the reduced EF, and 26% of the preserved EF cohort. The presence of LGE increased from 21.6%, when CMR was performed within 4 days of admission to 72.0% when CMR was performed on Day 4 of admission or later. Fifty-six patients had cardiac pathology. Late gadolinium enhancement was present in 35% of patients with pathological fibrosis and elevated T2-weighted STIR signal was present in 26% with a lymphocytic infiltration. Forty-one patients (40%) had MACE over a follow-up time of 5 months. The presence of LGE, LGE pattern, or elevated T2-weighted STIR were not associated with MACE. These data suggest caution in reliance on LGE or a qualitative T2-STIR-only approach for the exclusion of ICI-associated myocarditis.

High prevalence of self-reported autism spectrum disorder in the Propionic Acidemia Registry.

Propionic Acidemia (PA) is characterized by the accumulation of propionic acid (PPA), its toxic derivatives, and ammonia. The disease causes multiorgan damage, especially in heart, pancreas, and brain; seizures and intellectual disability are often described. Some PA children also show autism spectrum disorders (ASD). In this study, we have compiled data from 62 individuals from the Propionic Acidemia International Patient Registry and compared it to the published literature on the prevalence of autism in PA. The PA registry shows a significant proportion of ASD diagnoses that is consistent with the combined prevalence reported in the literature. It also shows that ASD in PA is gender balanced and it is diagnosed at older ages (median age 8 years) than in the national registry for autism (median age 4.3 years), which raises the possibility, among others, of PA specific risk factors affecting the natural history of ASD. Data from patient registries provide valuable information on studying the mechanisms involved in a rare disease, although more outreach effort must be done to increase participation and consistency in data entry.

Factors Influencing the Generation of Evidence from Simple Data Held in International Rare Disease Patient Registries.

Rare diseases (defined as affecting < 1 in 2000 Europeans) may collectively affect up to approximately 8% of the population. The low prevalence of individual diseases limits patient studies and data collection is a key challenge; international rare disease patient registries are essential for optimal data collection and research. Registry data achieves value when research conducted on them are published-this is termed evidence generation. The aim of this study was to examine selected factors and their association with evidence generation, via scientific publication, from international rare disease patient registry data. All international rare disease patient registries listed in the Orphanet 2018 report were analysed. Rates of scientific publications were compared by funding stream, disease area and registry size using multivariable regression analyses. Publication characteristics, such as novelty of findings, were also compared by registry funding stream, disease area and duration of operation. Privately funded registries had approximately two to four times higher rates of scientific publication compared with publically funded registries, with adjusted rate ratios of 1.85 (95% confidence interval [CI] 1.07-3.22) and 4.18 (95% CI 2.54-6.87) for private not-for-profit and private for-profit funding, respectively. The inclusion of outcomes, use of pharmaceutical medicines, novel findings and citation rate for publications generated from patient registries with any private funding was not significantly different from those attributed to only publicly funded registries. The results of this study indicate that privately funded international rare disease patient registries produce significantly more evidence than their publicly funded counterparts. Examination of the quality indicators of these publications showed they were of the same high quality as those generated from publicly funded patient registry data.

Incidence of major adverse cardiovascular events among patients with provoked and unprovoked venous thromboembolism: Findings from the Registro Informatizado de Enfermedad Tromboembólica Registry

ObjectiveOverlap exists between the risk factors for coronary artery disease and venous thromboembolism (VTE). However, a paucity of data is available on the incidence of major acute cardiovascular events (MACE) and major adverse limb events (MALE) among patients presenting with VTE. Moreover, it is unknown whether the rate of cardiovascular outcomes differs among patients with unprovoked vs provoked VTE. MethodsWe analyzed the data from 2009 to 2017 in the Registro Informatizado de Enfermedad Tromboembólica registry, an ongoing, multicenter, international registry of consecutive patients with a diagnosis of objectively confirmed VTE. The query was restricted it to patients with data entry for the arterial outcomes. The baseline prevalence of coronary artery disease risk factors was compared between patients with provoked (ie, immobility, cancer, surgery, travel >6 hours, hormonal causes) and unprovoked VTE. After the initial VTE event, we followed up patients for the composite primary outcome of incident MACE (ie, stroke, myocardial infarction, unstable angina) and/or MALE (ie, major limb events). We used the χ2 test for baseline associations and a Cox proportional hazard for multivariate analysis. We used IBM SPSS, version 24 (IBM Corp, Armonk, NY) for statistical analysis. A P value of <.05 was considered statistically significant. ResultsWe analyzed the data from 41,259 patients with VTE, of whom 22,633 (55.6%) had experienced a provoked VTE. During follow-up, the patients with provoked VTE were more likely to develop MACE or MALE than were patients with unprovoked VTE (hazard ratio [HR], 1.3; 95% confidence interval [CI], 1.1-1.5). The association of arterial events with recent immobility (HR, 1.4; 95% CI, 1.5-12.1) and cancer (HR, 1.7; 95% CI, 1.4-1.9) was strong. After adjusting for multiple conventional cardiovascular risk factors, provoked VTE, compared with unprovoked VTE, was significantly associated with an increased hazard for MACE (HR, 1.4; 95% CI, 1.1-1.7). Cancer remained a significant adjusted predictor for both MACE (HR, 1.7; 95% CI, 1.4-2.1) and MALE (HR, 2.1; 95% CI 1.01-4.6) in those with provoked VTE. ConclusionsAmong patients with VTE, provoked cases, specifically those with cancer-associated VTE, have an increased risk of major arterial events.

Sex Differences in Risk Factors, Clinical Presentation, Treatment and Outcomes of Patients Presenting with Acute Pulmonary Embolism

Background Pulmonary embolism (PE) is a major cause of morbidity and mortality in both the United States and worldwide. There is a paucity of contemporary clinical registry data regarding sex differences in the clinical presentation, treatment and outcomes of patients with acute PE. Methods Patients with PE from the RIETE (Registro Informatizado Enfermedad Trombo Embólica), a multicenter international prospective registry of patients with venous thromboembolism, were included. Patient characteristics between groups were compared using t-tests for continuous variables and chi-square tests for categorical variables. Multivariable logistic regression adjusting for baseline characteristics, clinical presentation and therapies was used to compare outcomes between both sexes. Outcomes included all-cause mortality, recurrent venous thromboembolism (VTE), and major bleeding through 30 days after initiation of PE treatment as well as all-cause mortality through 90 days. Results From January 2001 through June 2019, 41,477 patients with an acute PE were enrolled, of whom 22,057 (53%) were women. Women were older (mean age +/- standard deviation: 69 +/- 18 years versus 65 +/- 16 years), had higher body mass index (BMI) and were less likely to have cancer than men (Table 1). Women were also less likely to have prior VTE, chronic lung disease, history of MI or angina or an unprovoked PE but more likely to have recent immobilization, chronic heart failure, arterial hypertension, leg varicosities and depression. Women smoked less and fewer women tested positive for an inherited thrombophilia compared to men. Initial presentation: Women presented more frequently with hypotension, tachycardia, dyspnea, syncope and altered mental status than men but women reported less frequently hemoptysis, cough or chest pain. The location of PE was similar between the sexes. Similarly, there was no difference in the initial medical treatment such as unfractionated heparin (UFH) between men and women. However, more men underwent embolectomy and had inferior vena cava filters (IVCF) placed. During the course of anticoagulation (mean duration: 311 days for women and 315 days for men), women received a higher mean dose of low molecular weight heparin (181 [+/-41] International Units (IU)/kilogram (kg)/day versus 178 [+/-40] IU/kg/day, p &lt;0.001) compared to men. For the long-term therapy, women were less likely to receive a direct oral anticoagulant (DOAC). Follow up: Women were less likely to die at 30-days (OR 0.81; 95% CI 0.67-0.97, p &lt;0.05) and 90-days, (OR 0.83; 95% CI 0.74-0.94, p &lt;0.01) and less likely to have recurrent DVT (OR 0.61; 95% CI 0.41-0.91, p &lt;0.05), but more likely to suffer from major bleeding (OR 1.31; 95% CI 1.07-1.61, p &lt;0.01) compared with men. There was no difference in the rates of recurrent PE (OR 1.16; 95% CI 0.83-1.61; Table 2). Conclusion In this international multicenter registry including &gt;40,000 patients with an acute PE, we found that despite presenting with more signs and symptoms of severe PE, women were more likely to be alive at 30 and 90 days and had fewer DVT recurrences but more major bleeds than men. Disclosures Rosovsky: Dova Pharmaceuticals: Consultancy; Bristol-Myers Squibb: Research Funding; Janssen Pharmaceuticals: Consultancy, Research Funding.

Worldwide Variations in Demographics, Management, and Outcomes of Acute Pancreatitis

Few studies have compared regional differences in acute pancreatitis. We analyzed data from an international registry of patients with acute pancreatitis to evaluate geographic variations in patient characteristics, management, and outcomes. We collected data from the APPRENTICE registry of patients with acute pancreatitis, which obtains information from patients in Europe (6 centers), India (3 centers), Latin America (5 centers), and North America (8 centers) using standardized questionnaires. Our final analysis included 1612 patients with acute pancreatitis (median age, 49 years; 53% male, 62% white) enrolled from August 2015 through January2018. Biliary (45%) and alcoholic acute pancreatitis (21%) were the most common etiologies. Based on the revised Atlanta classification, 65% of patients developed mild disease, 23% moderate, and 12% severe. The mean age of patients in Europe (58 years) was older than mean age for all 4 regions (46 years) and a higher proportion of patients in Europe had comorbid conditions (73% vs 50% overall). The predominant etiology of acute pancreatitis in Latin America was biliary (78%), whereas alcohol-associated pancreatitis accounted for the highest proportion of acute pancreatitis cases in India (45%). Pain was managed with opioid analgesics in 93% of patients in North America versus 27% of patients in the other 3 regions. Cholecystectomies were performed at the time of hospital admission for most patients in Latin America (60% vs 15% overall). A higher proportion of European patients with severe acute pancreatitis died during the original hospital stay (44%) compared with the other 3 regions (15%). We found significant variation in demographics, etiologies, management practices, and outcomes of acute pancreatitis worldwide. ClinicalTrials.gov number: NCT03075618.

Venous Thromboembolism in Patients with Liver Cirrhosis: Findings from the RIETE (Registro Informatizado de la Enfermedad TromboEmbolica) Registry.

Patients with cirrhosis are not only at an increased risk of bleeding but also at risk of venous thromboembolism (VTE). We sought to determine the clinical characteristics, management, and outcomes after VTE in patients with cirrhosis. We used the data from RIETE (Registro Informatizado de la Enfermedad TromboEmbolica), an international registry of patients with VTE, to compare the outcomes in patients with and without cirrhosis. Main outcomes included all-cause mortality, pulmonary embolism (PE)-related mortality, recurrent VTE, and bleeding. Among 43,611 patients with acute VTE, 187 (0.4%) had cirrhosis. Of these, 184 (98.4%) received anticoagulation for a median of 109 days (interquartile range [IQR]: 43-201 days), most commonly with enoxaparin (median dose: 1.77 [IQR: 1.38-2.00] mg/kg/day). Compared with patients without cirrhosis, those with cirrhosis had a higher rate of all-cause mortality (10.7 vs. 3.4%; odds ratio [OR]: 3.41; 95% confidence interval [CI]: 2.03-5.46) and fatal bleeding (2.1 vs. 0.2%; OR: 13.94; 95% CI: 3.65-37.90) but similar rates of fatal PE (0.5 vs. 0.5%; OR: 1.17; 95% CI: 0.03-6.70). Patients with cirrhosis had a higher rate of all-cause mortality per 100 patient-years of follow-up (58.9 vs. 16.0; hazard ratio [HR]: 3.70; 95% CI: 2.69-4.91). One-year hazard ratio of clinically relevant bleeding (HR: 2.86; 95% CI: 1.91-4.27), fatal bleeding (HR: 8.51; 95% CI: 3.5-20.7), or recurrent VTE (HR: 2.08; 95% CI: 1.00-4.36) was higher in patients with cirrhosis. Cirrhosis is a challenging comorbidity in patients with VTE. Most patients were treated with anticoagulation and had an elevated risk of recurrence, similar risk of fatal PE, and a very high risk of bleeding including fatal bleeds.

P4790Haematuria is not elevated in AF patients treated with NOACs versus VKAs: GARFIELD-AF study

Abstract Background Haematuria in atrial fibrillation (AF) patients taking oral anticoagulants (OACs) is usually viewed as less serious than intracranial and gastrointestinal bleeding. It is speculated that haematuria may result from renal excretion of active new oral anticoagulants (NOACs) causing a direct anticoagulating effect in the urinary tract. Vitamin K antagonists (VKAs) such as warfarin, on the other hand, undergo hepatic metabolism and may pose lower risk of haematuria. This large registry study investigated whether NOACs more likely cause haematuria compared with VKAs. Purpose To assess whether there is any difference in the incidence rate of haematuria in AF patients taking NOACs versus VKAs using data from the GARFIELD-AF registry. Methods GARFIELD-AF is an international prospective registry of nonvalvular AF patients with at least one additional risk factor for stroke, followed for at least 2 years. Macroscopic haematuria was identified by local investigators. Event rates were estimated by Poisson model. Adjusted hazard ratio (HR) for haematuria between treatment groups was calculated using overlap-weighted Cox model including a range of patient demographics and clinical parameters as variables. Only the first haematuria occurrence was considered. Patients who were not treated with either VKAs or NOACs were excluded. Results Among a registry population of 34,926 patients 24,079 were anticoagulated and 24,061 had available follow-up data. Baseline characteristics were evenly balanced between the VKAs and NOACs subgroups, except a somewhat higher proportion of VKA patients than NOAC patients received concomitant antiplatelet therapy. Rate of haematuria was similar between the two groups: VKAs, 115/12,307 cases (0.9% over study period; 0.55 [95% CI, 0.46–0.65] per 100 patient-years); NOACs, 119/11,754 cases (1.0% over study period; 0.49 [95% CI, 0.41–0.59] per 100 patient-years). Over 2 years cumulatively, adjusted HR for haematuria in NOAC group versus VKA was 0.85 (95% CI, 0.63–1.15; p=0.29). Most haematuria cases (approximately 94%) were minor or clinically relevant non-major bleeds, occurring at a similar rate in both subgroups. Major bleeds were very rare. No intervention was necessary in two thirds haematuria cases (65.2%); surgical procedures were performed in only 8.3%. No haematuria-related deaths were observed. Incidence of haematuria Conclusions The incidence and severity of haematuria were not increased in AF patients taking NOACs versus VKAs. Haematuria may occur in approximately one in 100 AF patients on long-term OACs therapy and is usually non-serious. Acknowledgement/Funding The GARFIELD-AF registry is funded by an unrestricted research grant from Bayer AG.

TCT-84 Renal Denervation With Symplicity Spyral Catheter in the Global Symplicity Registry: Safety and Efficacy at 3 Years

Results from the GSR (Global Symplicity Registry) for patients treated with the Symplicity Spyral catheter on a limited cohort were presented previously. The current analysis presents data on safety and efficacy outcomes up to 3 years. GSR is a prospective, international registry of patients with

Outcomes from an international multicenter registry of patients with acute gastrointestinal bleeding undergoing endoscopic treatment with Hemospray.

Acute gastrointestinal bleeding carries poor outcomes unless prompt endoscopic hemostasis is achieved. Mortality in these patients remains significant. Hemospray is a novel intervention that creates a mechanical barrier over bleeding sites. We report the largest dataset of patient outcomes after treatment with Hemospray from an international multicenter registry. Prospective data (Jan 2016-May 2018) from 12 centers across Europe were collected. Immediate hemostasis was defined as endoscopic cessation of bleeding within 5min after application of Hemospray. Rebleeding was defined as subsequent drop in hemoglobin, hematemesis, persistent melena with hemodynamic compromise post-therapy. Three hundred and fourteen cases were recruited worldwide (231 males, 83 females). Median pretreatment Blatchford score was 11 (IQR: 8-14) and median complete Rockall score (RS) was 7 (IQR: 6-8) for all patients. Peptic ulcer disease (PUD) was the most common pathology (167/314=53%) and Forrest Ib the most common bleed type in PUD (100/167=60%). 281 patients (89.5%) achieved immediate hemostasis after successful endoscopic therapy with Hemospray. Rebleeding occurred in 29 (10.3%) of the 281 patients who achieved immediate hemostasis. Seven-day and 30-day all-cause mortality were 11.5% (36/314) and 20.1% (63/314), respectively (lower than the predicted rates as per the RS). Similar hemostasis rates were noted in the Hemospray monotherapy (92.4%), combination therapy (88.7%) and rescue therapy (85.5%) groups. These data show high rates of immediate hemostasis overall and in all subgroups. Rebleeding and mortality rates were in keeping/lower than predicted rates.

Prospective Observational International Registry of Patients With Newly Diagnosed Peripheral T Cell Lymphoma.

Prospective Observational International Registry of Patients With Newly Diagnosed Peripheral T Cell Lymphoma.

Stereotactic body radiotherapy (SBRT) for colorectal liver metastasis: Clinical outcomes from the international multi-institutional RSSearch Patient Registry.

e15040 Background: We investigated factors associated with clinical outcome for liver metastases from colorectal primary tumors treated with Stereotactic Body Radiotherapy (SBRT) from a multi-center, international, prospective patient registry. Methods: A subgroup of patients with colorectal liver metastases treated with SBRT was identified from the RSSearch Patient Registry. Patient, tumor and treatment characteristics associated with outcome were evaluated. Dose fractionations were normalized to BED10. Overall survival (OS) and local control (LC) were evaluated using Kaplan Meier analysis and log-rank test. Results: 217 patients with 233 liver metastases from primary colorectal cancer treated with SBRT between 2005-2017 and enrolled in the RSSearch Patient Registry were included. The median follow-up was 15 months (1–75 months). 77% of patients received prior or concurrent chemotherapy. Median tumor volume was 21.95 cm3 (0.5 – 638 cc), median SBRT dose was 45 Gy (16 – 60 Gy) delivered in a median of 3 fractions (1-5). Median number of liver metastases was 1 (1-8). Median overall survival (OS) was 27 months; median local control (LC) was 41 months. One and two-year OS was 75% and 55%, respectively. One and two-year LC was 75% and 66%, respectively. Higher BED10 was associated with improved LC with median LC of 44 months for BED10 ≥ 100 Gy vs 39 months for BED10 &lt; 100 Gy (p = 0.0007). Higher BED10 was also associated with improved OS: median of 33 months for BED10 ≥ 100 Gy vs to 18 months for BED10 &lt; 100 Gy (p = 0.0009). Smaller tumor volume was associated with improved OS: median OS of tumor volume was 34 months for tumors &lt; 20 cc vs 20 months for tumors ≥ 22cc (p = 0.0037). Local control was not significantly associated with tumor volume: median LC for tumor &lt; 22 cc vs ≥ 22cc was 44 months vs 39 months, respectively (p = 0.193). Age, prior or current chemotherapy and BMI were not associated with OS or LC. Conclusions: In this multi-institutional prospective cohort, OS and LC were favorably correlated with small tumor volume and higher BED10.

The adjusted global antiphospholipid syndrome score (aGAPSS) and the risk of recurrent thrombosis: Results from the APS ACTION cohort

ObjectivesTo assess whether patients with antiphospholipid syndrome (APS) and history of recurrent thrombosis have higher levels of adjusted Global AntiphosPholipid Syndrome Score (aGAPSS) when compared to patients without recurrent thrombosis. MethodsIn this cross-sectional study of antiphospholipid antibody (aPL)-positive patients, we identified APS patients with a history of documented thrombosis from the AntiPhospholipid Syndrome Alliance For Clinical Trials and InternatiOnal Networking (APS ACTION) Clinical Database and Repository (“Registry”). Data on aPL-related medical history and cardiovascular risk factors were retrospectively collected. The aGAPSS was calculated at Registry entry by adding the points corresponding to the risk factors: three for hyperlipidemia, one for arterial hypertension, five for positive anticardiolipin antibodies, four for positive anti-β2 glycoprotein-I antibodies and four for positive lupus anticoagulant test. ResultsThe analysis included 379 APS patients who presented with arterial and/or venous thrombosis. Overall, significantly higher aGAPSS were seen in patients with recurrent thrombosis (arterial or venous) compared to those without recurrence (7.8 ± 3.3 vs. 6 ± 3.9, p<0.05). When analyzed based on the site of the recurrence, patients with recurrent arterial, but not venous, thrombosis had higher aGAPSS (8.1 ± SD 2.9 vs. 6 ± 3.9; p<0.05). ConclusionsBased on analysis of our international large-scale Registry of aPL-positive patients, the aGAPSS might help risk stratifying patients based on the likelihood of developing recurrent thrombosis in APS.

Mo1990 – Adherence to the Gluten-Free Diet and Celiac Disease Patient Outcomes: Real World Evidences from an International Patient Registry, Icureceliac

Mo1990 – Adherence to the Gluten-Free Diet and Celiac Disease Patient Outcomes: Real World Evidences from an International Patient Registry, Icureceliac