Worldwide Registry Research Articles

Experiences from the German COVID-19 register

Eine SARS-CoV-2(„severe acute respiratory syndrome coronavirus 2“)-Infektion stellt für mehrere nephrologische Patientengruppen ein besonderes Risiko dar. Im Rahmen einer Pandemie sind dialysepflichtige Patienten ein besonders vulnerables Patientenkollektiv. Erste internationale Daten weisen auf eine deutlich erhöhte Mortalität von dialysepflichtigen Patienten im Rahmen einer SARS-CoV-2-Infektion hin. Aufgrund der erheblichen Unterschiede zwischen den Gesundheitssystemen, (staatlichen) Präventionsmaßnahmen, Therapiemöglichkeiten etc. in den verschiedenen Ländern weltweit sind lokale oder nationale Registerdaten im internationalen Kontext nicht ohne Weiteres übertragbar. Um zuverlässige Daten zur Prävalenz und Mortalität der SARS-CoV-2-Infektion bei dialysepflichtigen Patienten in Deutschland zu erheben, wurde unter dem Schirm der Deutschen Gesellschaft für Nephrologie ein Register für Dialysepatienten mit einer SARS-CoV-2-Infektion entwickelt. In diesem Rahmen erfolgt eine wöchentliche standardisierte Datenerhebung, die einen zeitnahen Überblick über die Fallzahlen und ggf. die Gewinnung neuer wissenschaftlicher Erkenntnisse ermöglichen soll. Insbesondere in der aktuellen Phase der Pandemie (Herbst 2020), die mit einer Vervielfachung der Anzahl der täglich Neuerkrankten innerhalb weniger Wochen einhergeht, sind solche Daten für eine Einschätzung und Anpassung des personellen, strukturellen und organisatorischen Bedarfs sowie der Kapazitäten für die Behandlung dieser Patienten hoch relevant.

Regional differences in PCI practice and clinical outcomes among patients with diabetes mellitus enrolled in a contemporary world-wide registry

Abstract Background Diabetes mellitus (DM) is a major risk factor for coronary artery disease (CAD) and PCI. Little is known about differences in PCI patterns and outcomes among DM patients across the globe. Purpose We aimed to determine differences in clinical outcomes and PCI practices among DM patients undergoing contemporary PCI across the continents. Methods e-Ultimaster is a prospective worldwide registry that enrolled 36; 671 patients and 1-year follow-up is currently available for 94,2% of the patients. All underwent PCI with a thin strut sirolimus-eluting stent with abluminal biodegradable polymer. This abstract focus on the DM population. Primary endpoint was target lesion failure (TLF) at 1-year (cardiac death, target vessel myocardial infarction (MI), clinically driven target lesion revascularization). A Clinical Event Committee adjudicated all endpoint-related adverse events. Patients were divided according to four regions of enrolment: Europe (EU), Asia (A), Africa/Middle East (A/ME), and Mexico/South America (M/SA). Results The prevalence of DM in e-Ultimaster ranged from 24.3% in E to 47.5% in A/ME. Among 9709 DM patients, 60% were enrolled in EU, 21% in A, 11% in A/ME and 8% in M/SA. Mean age ranged from 61.7 year in A as well as A/ME to 67.5 years in EU. The highest proportion of insulin requiring DM was found in A/ME (32.4%). Presentation with acute coronary syndromes ranged from 49% in A/ME to 55.6% in M/SA. The rate of primary endpoint (TLF) at one year was 4.2%. Definite/probable stent thrombosis (ST) occurred in 0.7% of at 1-year. Independent predictors of TLF included age, insulin-requiring DM, renal failure, previous PCI, number of lesions identified, presence of ACC/AHA type C lesions, treatment of left main lesions, treatment of bifurcation lesions, and number of stents implanted. Independent predictors of definite/probable ST included male gender, renal failure, history of MI, ST-elevated MI at presentation and number of lesions identified. TLF occurred in 2.1% in A/ME, 3.1% in A, 4.4% in M/SA and 5.0% in E. Definite/probable ST was lowest in A (0.3%) and A/ME (0.4%) and highest in M/SA and EU (both 0.9%). Penetration of radial access ranged from 86.0% in EU to 56.9% in A/ME. The use of intravascular imaging ranged from 3.9% in EU to 30.3% in A. Use of dual antiplatelet therapy (DAPT), left at the discretion of the operator, was lowest in EU (92.9% at 3 months; 63.8% at 1 year) and highest in A (94.5% at 3 months; 82.6% at 1 year). Conclusions The analysis on more than 9000 DM patients treated with the same contemporary stent within a world-wide registry with defined inclusion/exclusion criteria and adjudicated clinical events showed favourable clinical outcomes at one year and detected major differences in patient characteristics, PCI pattern, DAPT prescription and clinical outcomes across continents. Data on the entire e-Ultimaster DM population will be available for ESC. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Terumo Europe

Clinical practice and outcomes in elderly STEMI patients undergoing PCI with new generation DES – data from a large worldwide registry

Abstract Background The best treatment option for elderly patients with acute myocardial infarction (MI) remains unclear. Purpose We aimed to determine clinical practice and outcomes of PCI with a new generation DES in patients with ST-elevated MI (STEMI), aged ≥80 years included in a one of the largest real-world PCI registries. Methods e-Ultimaster is a prospective, world-wide, multi-centre registry that enrolled 36,671 patients with coronary artery disease, treated with a thin strut sirolimus-eluting stent with abluminal bioresorbable polymer coating, across 50 countries. 34,538 patients who completed 1-year follow-up or who died were included in the analysis. The primary endpoint was 1-year target lesion failure (TLF: cardiac death, target vessel (TV) MI, clinically driven (CD) target lesion revascularization (TLR)). An Clinical Event Committee adjudicated all endpoint-related adverse events. Results 6863 presented with STEMI at baseline (19.9%). Mean age of STEMI patients was 61.0±11.7 years, with 78.8% males. Diabetes was present in 20.9% and hypertension in 52.4%. Of 6863 STEMI patients, 430 patients (6.2%) were aged ≥80 years, with 46.5% females compared to 19.5% females in the younger group. Patients in the older group had more comorbidities (hypertension and renal impairment) and more often took oral anticoagulant medication (9.2% vs 3.9%; p<0.001). At discharge 94.9% of older STEMI patients were on dual antiplatelet therapy (DAPT) as compared to 97.6% of younger STEMI patients (p=0.002). Older STEMI patients more often took clopidogrel as second antiplatelet agent (54.7% vs 39.8%; p<0.001) and were less often on prasurgrel (2.3%vs 10.9%; p<0.001) and ticagrelor (41.2% vs 48.1%; p=0.005). STEMI patients in the older group more often had multivessel disease (52.1 vs 45.8%; p=0.01), treatment of the left main artery (4.7 vs 1.4%; p<0.001) and more calcified lesions (18.8 vs 11.2%; p<0.001). Other lesion characteristics were similar between the two groups. Preferred access approach was radial and was alike in the two groups (87.0 vs 84.0%; p=0.10) In-hospital mortality was more frequent in older STEMI patients (2.3% vs 0.8%; p=0.003). More bleedings were observed in older vs younger STEMI patients at discharge. One-year TLF was significantly higher in older age group (7.0% vs 3.0%; p<0.01), mainly driven by increased rates of cardiac death. All-cause mortality and bleedings were also more frequent in older STEMI patients. No differences were observed in revascularization or ST rates (1.4 vs 1.1%; p=0.48). Conclusions In elderly patients with STEMI, in-hospital mortality rates as well as bleeding rates were higher as compared to younger patients, while 1-year rates of revascularization and ST did not differ between the groups. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Terumo Europe

Renal and Bladder Cancer During Pregnancy: A Review of 47 Cases and Literature-based Recommendations for Management

ObjectiveTo provide contemporary gestational age-specific recommendations for management, a retrospective series of patients with renal or bladder cancer during pregnancy is reported. MethodsObstetric and oncological data of pregnant patients with a diagnosis of renal or bladder cancer were selected from the worldwide registry of the International Network of Cancer, Infertility and Pregnancy. In addition, the literature was reviewed for recent case reports since last reviews in 2014 for renal cancer and 2004 for bladder cancer. ResultsInternational Network of Cancer, Infertility and Pregnancy registered 22 cases (14 renal cancer and 8 bladder cancer), diagnosed between 1999 and 2017, and the literature reported 15 cases with renal cancer and 10 cases with bladder cancer between 2004 and 2019. Most common symptoms for renal and bladder cancer were pain (28%) and hematuria (66%), respectively. In more than half of the patients, surgical treatment was performed during pregnancy. Preterm deliveries were mostly medically induced (12 of 17, 71%) and all patients with a planned delivery before 34 weeks had advanced cancer. For renal and bladder cancer respectively, 79% and 87% of patients obtained complete remission. Advanced cancer stages had worse prognosis; 3 of 7 patients with known follow-up deceased within 15 months after diagnosis. ConclusionGestational age at diagnosis determines further management of renal and bladder cancers during pregnancy. Advanced stages challenge decision-making. The maternal needs for immediate treatment, and the neonatal risks including the impact of a preterm delivery should be discussed in a multidisciplinary setting while respecting the patient's autonomy.

Risk of Severe Coronavirus Disease 2019 in Patients With Inflammatory Bowel Disease in the United States: A Multicenter Research Network Study

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Clinical trials of xenotransplantation: The need for a worldwide registry.

Clinical trials of xenotransplantation: The need for a worldwide registry.

Role of HLA-B27 in the comorbidities observed in Axial Spondyloarthritis: Data from COMOSPA.

To analyze the potential association between the presence of HLA-B27 and the different comorbidities observed in Axial Spondyloarthritis patients. A comparative cross-sectional study including Axial Spondyloarthritis patients from COMOSPA registry. COMOSPA is a worldwide registry that includes a wide set of anthropometric and clinical variables from 3984 patients with Spondyloarthritis. The registry also includes the most frequent comorbidities observed in Spondyloarthitis such as obesity, hypertension, diabetes, hyperlipidemia, heart ischemic disease, stroke, renal failure, neoplasms, peptic ulcer, diverticulitis, chronic obstructive pulmonary disease, and the presence of osteoporosis. A descriptive analysis and a multiple logistic regression model was performed including all variables assessed. 2370 patients fulfilled ASAS criteria of Axial Spondyloarthritis patients and were included in the study. 1858 (78.4%) of them were HLA-B27 positive. HLA-B27 positive Axial Spondyloarthritis patients presented significantly higher percentage of male sex, longer disease duration, higher percentage of definite Ankylosing Spondylitis, higher CRP levels, and were also more frequent tobacco consumers and excessive alcohol intakers compared to the negatives. However, disease activity measured by BASDAI, BASFI and ASDAS-CRP were all significantly higher in the HLA-B27 negative patients compared to the positive ones. The only association observed between any comorbidity and presence of HLA-B27 genotype was the presence of osteoporosis, even after adjusting in the multivariate analysis for all variables assessed. The association observed between the HLA-B27 genotype and the presence of osteoporosis in Axial Spondyloarthritis patients could be of great relevance given the impact of osteoporosis in the phenotypical frame of these patients.

Huntingtin Lowering Strategies.

Trials using antisense oligonucleotide technology to lower Huntingtin levels in Huntington’s disease (HD) are currently ongoing. This progress, taking place only 27 years after the identification of the Huntingtin gene (HTT) in 1993 reflects the enormous development in genetic engineering in the last decades. It is also the result of passionate basic scientific work and large worldwide registry studies that have advanced the understanding of HD. Increased knowledge of the pathophysiology of this autosomal dominantly inherited CAG-repeat expansion mediated neurodegenerative disease has led to the development of several putative treatment strategies, currently under investigation. These strategies span the whole spectrum of potential targets from genome editing via RNA interference to promoting protein degradation. Yet, recent studies revealed the importance of huntingtin RNA in the pathogenesis of the disease. Therefore, huntingtin-lowering by means of RNA interference appears to be a particular promising strategy. As a matter of fact, these approaches have entered, or are on the verge of entering, the clinical trial period. Here, we provide an overview of huntingtin-lowering approaches via DNA or RNA interference in present clinical trials as well as strategies subject to upcoming therapeutic options. We furthermore discuss putative implications for future treatment of HD patients.

One-year clinical outcomes in patients with renal insufficiency after contemporary PCI: data from a multicenter registry

BackgroundChronic kidney disease (CKD) is highly prevalent in patients with coronary artery disease (CAD).ObjectiveThe outcome following revascularization using contemporary technologies (new-generation abluminal sirolimus-eluting stents with thin struts) in patients with CKD (i.e., glomerular filtration rate of < 60 mL/min/1.73m2) and in patients with hemodialysis (HD) is unknown.Methodse-Ultimaster is a prospective, single-arm, multi-center registry with clinical follow-up at 3 months and 1 year.ResultsA total of 19,475 patients were enrolled, including 1466 patients with CKD, with 167 undergoing HD. Patients with CKD had a higher prevalence of overall comorbidities, multiple/small vessel disease (≤ 2.75 mm), bifurcation lesions, and more often left main artery treatments (all p < 0.0001) when compared with patients with normal renal function (reference). CKD patients had a higher risk of target lesion failure (unadjusted OR, 2.51 [95% CI 2.04–3.08]), target vessel failure (OR, 2.44 [95% CI 2.01–2.96]), patient-oriented composite end point (OR, 2.19 [95% CI 1.87–2.56]), and major adverse cardiovascular events (OR, 2.34 [95% CI 1.93–2.83, p for all < 0.0001]) as reference. The rates of target lesion revascularization (OR, 1.17 [95% CI 0.79–1.73], p = 0.44) were not different. Bleeding complications were more frequently observed in CKD than in the reference (all p < 0.0001).ConclusionIn this worldwide registry, CKD patients presented with more comorbidities and more complex lesions when compared with the reference population. They experienced higher rate of adverse events at 1-year follow-up.Graphic abstractOne-year summary outcomes of contemporary PCI in renal insufficiency. CKD chronic kidney disease, POCE patient oriented composite endpoint, MACE major adverse cardiovascular events, TLF target lesion failure, TLR target lesion revascularization, ST stent thrombosis

Glucose transporter type 1 deficiency syndrome and the ketogenic diet.

Glucose transporter type 1 deficiency syndrome (GLUT1DS) is characterised by deficient glucose transport over the blood‐brain barrier and reduced glucose availability in the brain. This causes epilepsy, movement disorders, and cognitive impairment. Treatment with ketogenic diet provides ketones as alternative energy source. However, not all GLUT1DS patients are on dietary treatment (worldwide registry: 77/181 [43%] of patients). The current 25‐year experience allows evaluation of effects and tolerability of dietary treatment for GLUT1DS. To this end, literature was searched up to January 2019 for individual case reports and series reporting (side) effects of dietary treatment for GLUT1DS. Upon aggregation of data for analysis, we identified 270 GLUT1DS patients with dietary treatment with a mean follow‐up of 53 months. Epilepsy improved for 83% of 230 patients and remained unchanged for 17%, movement disorders improved for 82% of 127 patients and remained unchanged for 17%, and cognition improved for 59% of 58 patients and remained stable for 40%. Effects on epilepsy were seen within days/weeks and were most pronounced in patients with early treatment initiation. Effects on movement disorders were noticed within months and were strongest in patients with higher cerebrospinal fluid‐to‐blood glucose ratio. Although side effects were minimal, 18% of 270 patients reported poor compliance. In individual patients, symptoms deteriorated upon low ketosis, poor compliance, or treatment discontinuation. Based on the good tolerability and strong favourable effect of dietary treatment on GLUT1DS symptoms, we advocate dietary treatment in all GLUT1DS patients and prompt diagnosis or screening to allow early treatment.

333.8: Middle-East organ donation and transplantation activity 2018: results from the international registry on organ donation and transplantation (irodat).

Background: IRODaT is the first worldwide registry in organ donation and transplantation field, which contains statistics of deceased/living donors and transplants since 1998. Our goal is to provide throughout yearly summary reports a globally and regionally overview of donation and transplantation activities. On Middle East countries the gap between supply and demand of organs is growing every year. Living donation is the most widely practiced type of donation in the Middle East1. Methods: Each participant country is represented by a national reporter, who retrospectively registry their country activity into the website. All the data are validated previously to be published. IRODaT follows “The Critical Pathway of Deceased Donation2” definition, ensuring uniformity throughout the registry and aiding correct data interpretation. Our worldwide and regionally summary reports and figures can be accessed at www.irodat.org. Specialized reports for specific investigations are provided under request. Results: After twenty-years of experience IRODaT is a friendly and easy-to-use database. Out of the 111 countries with donation and transplantation activity on the world, 96 national reporters have submitted data at IRODaT. On 2018, some fluctuations (increments/decrements) on the actual deceased and living donors’ rates were recorded in Middle East countries. Middle East data showed that: Turkey has the worldwide highest rate of living donors per million of population (52pmp). Examples of countries with an increment from 2017 to 2018 on their deceased donors’ rates were: Israel from 10.7 to 13pmp, Turkey from 7 to 7.5pmp and United Arab Emirates from 0.32pmp to 0.86pmp in 2018. Countries like Saudi Arabia and Iran maintained their activity from 3.33pmp in 2017 to 3.1 pmp in 2018 and from 11.43 to 11.26 pmp respectively. Conclusions: The data available at IRODaT supports the research activities and planning strategies of organ donation and transplant institutions. Comparative data provides a worldwide and regional overview of which improvements are necessary for the optimization of the three donation models prevalent in the Middle East region: the Saudi, Iranian and Pakistani models.

TCT-289 Primary Endpoint Results of the World-Wide WIN Registry Assessing a Self-Apposing Stent for Revascularization of Coronary Arteries in Routine Clinical Practice

TCT-289 Primary Endpoint Results of the World-Wide WIN Registry Assessing a Self-Apposing Stent for Revascularization of Coronary Arteries in Routine Clinical Practice

TCT-245 Contemporary Bifurcation Treatment Practice: What We Can Learn From a Large Global Registry

A large worldwide registry provides a good opportunity to explore the real-world bifurcation treatment practice in >3,300 patients. e-ULTIMASTER is a large, prospective, multicenter registry that enrolled >37,000 patients treated with a thin-strut DES with bioresorbable polymer. Among 25,990

Foreign Body injuries in children in India: Recommendations for prevention from a comparative analysis with international experience

ObjectivesThis study aims to identify specific patterns of risk in order to contribute to the prevention of Foreign Body (FB) injuries by assessing FB injury characteristics in Indian children. MethodsSingle center case series are included in the worldwide registry on Foreign Bodies Injuries www.susysafe.org. Statistical analysis performed on FB injury data (age, medical information, FB anatomical location (ICD) and characteristics, and situational data) from 252 Indian children (0–14 years) was used to identify FB risk patterns. ResultsThe study included 252 FB injury cases, out of which 110 occurred in females (43.7%). Most of the reported FB injuries (N = 252) were located in the mouth, esophagus and stomach, or intestines and colon (34.5%), and in the nose (31.3%). The analysis of the median duration of all injuries (i.e., the difference between the reported injury time/date and the reported time/date of arrival at hospital) showed that children with a FB in the airways were those referred to the hospital latest (median of 332.50 min, p-value <0.001). With regards to FB type, the majority of FB objects were non-food items and ingestion of coins accounted for 25% of all FB injuries. ConclusionsCultural differences may exist with regards to the Indian diet being conducive to lower choking food risk for children, and to acceptability and accessibility to objects such as coins and stationery. Such findings should be taken into account when developing primary and secondary prevention strategies aimed at reducing the burden of such injuries in India.

Transcatheter Aortic Valve Replacement in Oncology Patients With Severe Aortic Stenosis

ObjectivesThe authors sought to collect data on contemporary practice and outcome of transcatheter aortic valve replacement (TAVR) in oncology patients with severe aortic stenosis (AS). BackgroundOncology patients with severe AS are often denied valve replacement. TAVR may be an emerging treatment option. MethodsA worldwide registry was designed to collect data on patients who undergo TAVR while having active malignancy. Data from 222 cancer patients from 18 TAVR centers were compared versus 2,522 “no-cancer” patients from 5 participating centers. Propensity-score matching was performed to further adjust for bias. ResultsCancer patients’ age was 78.8 ± 7.5 years, STS score 4.9 ± 3.4%, 62% men. Most frequent cancers were gastrointestinal (22%), prostate (16%), breast (15%), hematologic (15%), and lung (11%). At the time of TAVR, 40% had stage 4 cancer. Periprocedural complications were comparable between the groups. Although 30-day mortality was similar, 1-year mortality was higher in cancer patients (15% vs. 9%; p < 0.001); one-half of the deaths were due to neoplasm. Among patients who survived 1 year after the TAVR, one-third were in remission/cured from cancer. Progressive malignancy (stage III to IV) was a strong mortality predictor (hazard ratio: 2.37; 95% confidence interval: 1.74 to 3.23; p < 0.001), whereas stage I to II cancer was not associated with higher mortality compared with no-cancer patients. ConclusionsTAVR in cancer patients is associated with similar short-term but worse long-term prognosis compared with patients without cancer. Among this cohort, mortality is largely driven by cancer, and progressive malignancy is a strong mortality predictor. Importantly, 85% of the patients were alive at 1 year, one-third were in remission/cured from cancer. (Outcomes of Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis [TOP-AS]; NCT03181997)

Thoraco-Abdominal Abnormalities in Bardet-Biedl Syndrome: Situs Inversus and Heterotaxy

To characterize the diversity and prevalence of thoraco-abdominal abnormalities in Bardet-Biedl syndrome (BBS), a model ciliopathy for understanding the role of cilia in human health. The Clinical Registry Investigating BBS, a worldwide registry exploring the phenotype and natural history of BBS, was used to conduct the study. Protected health information was obtained by subject or family interview and Health Insurance Portability and Accountability Act-approved release of data including imaging studies and genetic testing. Echocardiography and imaging findings were independently confirmed by 2 cardiologists. Thoraco-abdominal abnormalities were identified in 6 of 368 (1.6%) subjects with a minimum prevalence of 1 in 60 Clinical Registry Investigating BBS participants. Diverse laterality defects were observed suggesting that the underlying ciliopathy randomly alters embryonic left-right axis orientation. Congenital heart disease, common in heterotaxy, was present in 2 subjects. Additional defects, uncommonly reported in BBS, were observed in the central nervous, genitourinary, gastrointestinal, and musculoskeletal systems in the subjects. No BBS genotype was favored in the cohort. One subject had genetic and clinical phenotype diagnostic of both primary ciliary dyskinesia and BBS. The variety of thoraco-abdominal abnormalities in BBS suggests the pleiotropic nature of these anomalies is not confined to a single pattern or genotype. Clinicians providing care to individuals with BBS should consider the increased prevalence of thoraco-abdominal anomalies in BBS. Individuals with features suggestive of other ciliopathies, such as primary ciliary dyskinesia, should undergo further evaluation for additional genetic disorders. ClinicalTrials.gov: NCT02329210.

Primary extra-uterine and extra-ovarian mullerian adenosarcoma: case report and literature review

BackgroundExtra-uterine mullerian adenosarcomas have varying biological behaviours depending on the presence of endometriosis or sarcomatous overgrowth. These behaviours manifest according to the tumours’ histological characteristics and sites of origin. The best treatment and oncologic outcome have not been clarified because only a few cases of extra-uterine and extra-ovarian adenosarcoma have been described in the literature. Here, we report a case of primary peritoneal adenosarcoma with sarcomatous overgrowth and review all reported cases of adenosarcomas arising outside of the uterus and outside the ovaries to identify the best treatment options and clarify outcomes.Case presentationA 79-year-old woman was referred to our Department with an abdominal mass resembling a fibroid with a haemorrhage. Her gynaecological history was negative. A transvaginal and transabdominal ultrasound examination revealed a multicystic mass resembling an ovarian tumour arising from the pelvis and extending up to the abdomen. At laparotomy a peritoneal mass arising from Douglas peritoneum was resected. The uterus and adnexa appeared normal, and a supra-cervical hysterectomy with bilateral salpingo-oophorectomy was performed. No macroscopic residual disease was present. Final pathology diagnosed a malignant peripheral nerve sheath tumors with divergent differentiation. Four weeks later a new, multicystic mass was found. Due to the progressive poor condition, the patient died four months after diagnosis. Histological slides were reviewed by external expert pathologists and the final diagnosis was of extra-genital adenosarcoma with sarcomatous overgrowth. Furthermore, we also collected and analysed articles written in English regarding extra-uterine and extra-ovarian adenosarcomas published between January 1974 and October 2016. PubMed was used as a database for this search. Clinical and pathological characteristics, treatments and outcomes were assessed.ConclusionsOnly 41 cases has been reported in literature. Previous endometriosis and sarcomatous overgrowth showed an inverse effect on prognosis. Endometriosis was confirmed to have a positive effect on disease free survival Complete surgical resection is the mainstay of treatment. A worldwide registry is urgently required to collect data to standardize treatment and to obtain reliable data on prognosis.

Efficacy and Safety of Polymer-Free Ultrathin Strut Sirolimus-Probucol Coated Drug-Eluting Stents for Chronic Total Occlusions: Insights from the Coroflex ISAR 2000 Worldwide Registry.

Objective Coronary revascularization in chronic total occlusion (CTO) is associated with improved clinical outcomes. The choice of the coronary stent is crucial in maintaining long-term vessel patency after CTO revascularization. We investigated the efficacy and safety of polymer-free ultrathin strut sirolimus-probucol coated drug-eluting stents (PF-SES) for CTO lesions. Methods Patients with CTO lesions treated with PF-SES were identified from the prospective multicenter international ISAR 2000 registry. The primary endpoint was clinically driven target lesion revascularization (TLR) at 9 months. Secondary endpoints were 9-month major adverse cardiac events (death, myocardial infarction, or TLR) (MACE) and the occurrence of stent thrombosis. Results A total of 111 patients with CTO lesions (n=127) were available for analysis. The 9-month clinical follow-up rate was 91%. The mean reference vessel diameter and lesion length were 2.76 mm ± 0.40 and 26.8 mm ± 13.1, respectively. The overall DAPT duration was 9.7 ± 2.8 months. Only one (1%) in-hospital MI was reported. The TLR and MACE rates at 9 months were 2% (2/101) and 5.9% (6/101), respectively. The 9-month accumulated rates of definite or probable stent thrombosis was 0% (0/101). Conclusion Revascularizations for CTO with PF-SES are associated with low rates of TLR and MACE at 9 months with no stent thrombosis. These initial findings need to be compared with results of other new generation DES of larger studies.

Lambl's Excrescences and Stroke: A Scoping Study.

Stroke / Cerebrovascular accident (CVA) is a leading cause of morbidity and mortality in the world. Ischemic stroke accounts for 87% of the cases, 14-30% of which is attributed to cardio-embolic stroke. Lambl’s excrescences (LE) were first described in 1856 by a Bohemian physician- VilemDusanLambl and is considered a rare cause of cardioembolic stroke subtype. LE are branched filiform structures with undulating movements, 1×4-10 mm in size that are usually found on aortic and mitral valves. An atheroma from LE or LE fragments per se may embolize to cerebrovascular arterial territory causing stroke. Multiple isolated cases of stroke associated with LE have been reported in the literature. We hereby report a scoping study of the findings associated with such cases. A total of 27 cases were identified after various scientific databases including PubMed and Google scholar were searched with keywords “lambi’s excrescences, stroke, cerebrovascular accidents”. Data from these cases were tabulated and analyzed. The mean age at presentation was 51 ± 14.2 (± SD) years with 55% of patient younger than 55 years of age. 56% of cases were males. Transesophageal echocardiogram was more effective in detecting LE when compared to transthoracic echocardiogram. LE were most often found on aortic valve and LE related stroke was most often noted in middle cerebral artery territory. Recurrent stroke was reported in 30%. Management of these cases was highly variable and likely derived from individual experience as LE management guidelines are largely lacking. Single and dual antiplatelet therapy, anticoagulation and valvularsurgery were among the various management strategies employed. We recommend dual antiplatelet after the first episode of CVA related to LE and an antiplatelet in combination with anticoagulation after the second CVA attributed to LE. Also it is reasonable to offer valve replacement after second CVA related to LE as the reccurence rate of CVA is high. Due to rarity in LE reporting and its management a shared decision making has to be made depending on the clinical status of the patient.The formation of a worldwide registry for LE using standardized reporting criteria for the diagnosis with or without incident stroke, would help establish guidelines for the diagnosis and management of this rare, yet serious disease with increased risk of morbidity and mortality.

Rationale and design of the worldwide prospective multicenter registry on radiation dose estimates of cardiac CT angiography in daily practice in 2017 (PROTECTION VI)

BackgroundCardiac computed tomography angiography (cardiac CTA) is an increasingly used versatile imaging method to evaluate coronary and cardiac morphology. Owing to improvements in technology, image quality has continuously improved over the last 10–20 years. At the same time, numerous non-randomized and randomized studies have been performed to reduce the associated radiation exposure. Currently, it is unclear if the advances in technology and knowledge about radiation reduction translated into reduced levels of cardiac CTA radiation dose in daily clinical practice as well as a wide utilization of dose-saving strategies. MethodsThe PROTECTION VI study is a multicenter, prospective, worldwide registry designed to evaluate radiation dose exposure, utilization of dose-saving strategies and diagnostic image quality during cardiac CTA in current daily practice. Assessment of image quality will be addressed by the evaluation of diagnostic image quality at the local study site and the calculation of quantitative image quality parameters in an imaging core laboratory. Above 4000 patients will be enrolled from approximately 70 sites in Europe, North America, South America, Asia and Australia. The study will analyze median radiation dose levels, image quality, frequency of use and efficacy of algorithms for dose reduction, and patient and study-related predictors associated with radiation dose. ConclusionsThe PROTECTION VI study is designed to provide a reliable estimate of current radiation dose for cardiac CTA and to assess the potential for additional dose reductions.