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      Reduction of Gastrointestinal Bleeding in Patients With Heyde Syndrome Undergoing Transcatheter Aortic Valve Implantation

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          Abstract

          Background:

          Heyde syndrome is the co-occurrence of aortic stenosis and gastrointestinal bleeding secondary to angiodysplasias. Surgical aortic valve replacement effectively reduces bleeding, but the effects of transcatheter aortic valve implantation (TAVI) are largely unknown. This study aimed to describe the reduction of gastrointestinal bleeding in patients with Heyde syndrome after TAVI and to identify the factors associated with rebleeding.

          Methods:

          We enrolled patients with Heyde syndrome from a prospective TAVI registry. Gastrointestinal bleeding episodes were assessed by the Bleeding Academic Research Consortium classification, and cumulative incidence functions were used to calculate cessation rates. Factors potentially associated with rebleeding were analyzed using logistic regression. Differences between Heyde and non-Heyde patients were assessed through a case-cohort study.

          Results:

          Between December 2008 and June 2020, 1111 patients underwent TAVI. There were 70 patients with Heyde syndrome (6.3%). In the first year following TAVI, gastrointestinal bleeding ceased in 46 of 70 patients (62% [95% CI, 50%–74%]). Bleeding episodes decreased from 3.2 (95% CI, 2.5–4.2) to 1.6 ([95% CI, 1.2–2.2] P=0.001) and hemoglobin levels increased from 10.3 (95% CI, 10.0–10.8) to 11.3 (95% CI, 10.8–11.6) g/dL ( P=0.007). Between 1 and 5 years after TAVI (35 [interquartile range, 21–51] months), 53 of 62 patients (83% [95% CI, 72%–92%]) no longer experienced gastrointestinal bleeding. Paravalvular leakage (≥mild) was associated with rebleeding risk (odds ratio, 3.65 [95% CI, 1.36–9.80]; P=0.010). Periprocedural bleeding was more common in Heyde than in control patients (adjusted odds ratio, 2.55 [95% CI, 1.37–4.73]; P=0.003).

          Conclusions:

          Patients with Heyde syndrome are at increased risk for periprocedural bleeding. Post-TAVI, gastrointestinal bleeding disappears in the majority of patients. Paravalvular leakage may curtail these clinical benefits.

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          Most cited references36

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          The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies.

          Much biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalisability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover three main study designs: cohort, case-control, and cross-sectional studies. We convened a 2-day workshop in September 2004, with methodologists, researchers, and journal editors to draft a checklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE Statement) that relate to the title, abstract, introduction, methods, results, and discussion sections of articles. 18 items are common to all three study designs and four are specific for cohort, case-control, or cross-sectional studies. A detailed Explanation and Elaboration document is published separately and is freely available on the Web sites of PLoS Medicine, Annals of Internal Medicine, and Epidemiology. We hope that the STROBE Statement will contribute to improving the quality of reporting of observational studies.
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            The Chi-square test of independence

            The Chi-square statistic is a non-parametric (distribution free) tool designed to analyze group differences when the dependent variable is measured at a nominal level. Like all non-parametric statistics, the Chi-square is robust with respect to the distribution of the data. Specifically, it does not require equality of variances among the study groups or homoscedasticity in the data. It permits evaluation of both dichotomous independent variables, and of multiple group studies. Unlike many other non-parametric and some parametric statistics, the calculations needed to compute the Chi-square provide considerable information about how each of the groups performed in the study. This richness of detail allows the researcher to understand the results and thus to derive more detailed information from this statistic than from many others. The Chi-square is a significance statistic, and should be followed with a strength statistic. The Cramer’s V is the most common strength test used to test the data when a significant Chi-square result has been obtained. Advantages of the Chi-square include its robustness with respect to distribution of the data, its ease of computation, the detailed information that can be derived from the test, its use in studies for which parametric assumptions cannot be met, and its flexibility in handling data from both two group and multiple group studies. Limitations include its sample size requirements, difficulty of interpretation when there are large numbers of categories (20 or more) in the independent or dependent variables, and tendency of the Cramer’s V to produce relative low correlation measures, even for highly significant results.
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              Wilcoxon-Mann-Whitney or t-test? On assumptions for hypothesis tests and multiple interpretations of decision rules.

              In a mathematical approach to hypothesis tests, we start with a clearly defined set of hypotheses and choose the test with the best properties for those hypotheses. In practice, we often start with less precise hypotheses. For example, often a researcher wants to know which of two groups generally has the larger responses, and either a t-test or a Wilcoxon-Mann-Whitney (WMW) test could be acceptable. Although both t-tests and WMW tests are usually associated with quite different hypotheses, the decision rule and p-value from either test could be associated with many different sets of assumptions, which we call perspectives. It is useful to have many of the different perspectives to which a decision rule may be applied collected in one place, since each perspective allows a different interpretation of the associated p-value. Here we collect many such perspectives for the two-sample t-test, the WMW test and other related tests. We discuss validity and consistency under each perspective and discuss recommendations between the tests in light of these many different perspectives. Finally, we briefly discuss a decision rule for testing genetic neutrality where knowledge of the many perspectives is vital to the proper interpretation of the decision rule.
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                Author and article information

                Contributors
                Journal
                Circ Cardiovasc Interv
                Circ Cardiovasc Interv
                HCV
                Circulation. Cardiovascular Interventions
                Lippincott Williams & Wilkins (Hagerstown, MD )
                1941-7640
                1941-7632
                05 July 2022
                July 2022
                : 15
                : 7
                : e011848
                Affiliations
                [1]Department of Gastroenterology and Hepatology (L.C.M.J.G., N.C.C.G., J.P.H.D., E.J.M.v.G.), Radboud University Medical Center, Nijmegen, the Netherlands.
                [2]Department of Cardiology (M.J.P.R., M.H.v.W., K.v.d.W., N.v.R.), Radboud University Medical Center, Nijmegen, the Netherlands.
                [3]Scientific Institute for Quality of Healthcare (IQ Healthcare) (R.P.A.), Radboud University Medical Center, Nijmegen, the Netherlands.
                [4]Department of Cardiology, Canisius Wilhelmina Ziekenhuis, Nijmegen, the Netherlands (E.S.Z.).
                [5]Department of Cardiology, Rijnstate, Arnhem, the Netherlands (R.P.).
                Author notes
                Correspondence to: Lia C.M.J. Goltstein, MD, Department of Gastroenterology and Hepatology, Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, the Netherlands. Email lia.goltstein@ 123456radboudumc.nl
                Article
                00006
                10.1161/CIRCINTERVENTIONS.122.011848
                9287099
                35861798
                ad836481-1c78-40f7-807c-679ddd2fb72c
                © 2022 The Authors.

                Circulation: Cardiovascular Interventions is published on behalf of the American Heart Association, Inc., by Wolters Kluwer Health, Inc. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution, and reproduction in any medium, provided that the original work is properly cited.

                History
                : 14 January 2022
                : 29 April 2022
                Categories
                10103
                10141
                Original Articles
                Structural Heart Disease
                Custom metadata
                TRUE
                T

                angiodysplasia,aortic valve stenosis,capillaries,hemorrhage,prevalence,transcatheter aortic valve replacement

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