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      Long-term clinical impact of permanent pacemaker implantation in patients undergoing transcatheter aortic valve implantation: a systematic review and meta-analysis

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          Abstract

          Aims

          The aims of this study is to assess by an updated meta-analysis the clinical outcomes related to permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) at long-term (≥12 months) follow-up (LTF).

          Methods and results

          A comprehensive literature research was performed on PubMed and EMBASE. The primary endpoint was all-cause death. Secondary endpoints were rehospitalization for heart failure, stroke, and myocardial infarction. A subgroup analysis was performed according to the Society of Thoracic Surgeon—Predicted Risk of Mortality (STS-PROM) score. This study is registered with PROSPERO (CRD42021243301). A total of 51 069 patients undergoing TAVI from 31 observational studies were included. The mean duration of follow-up was 22 months. At LTF, PPI post-TAVI was associated with a higher risk of all-cause death [risk ratio (RR) 1.18, 95% confidence interval (CI) 1.10–1.25; P < 0.001] and rehospitalization for heart failure (RR 1.32, 95% CI 1.13–1.52; P < 0.001). In contrast, the risks of stroke and myocardial infarction were not affected. Among the 20 studies that reported procedural risk, the association between PPI and all-cause death risk at LTF was statistically significant only in studies enrolling patients with high STS-PROM score (RR 1.25, 95% CI 1.12–1.40), although there was a similar tendency of the results in those at medium and low risk.

          Conclusion

          Patients necessitating PPI after TAVI have a higher long-term risk of all-cause death and rehospitalization for heart failure as compared to those who do not receive PPI.

          Graphical Abstract

          Graphical Abstract

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          Most cited references57

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          Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group.

          Because of the pressure for timely, informed decisions in public health and clinical practice and the explosion of information in the scientific literature, research results must be synthesized. Meta-analyses are increasingly used to address this problem, and they often evaluate observational studies. A workshop was held in Atlanta, Ga, in April 1997, to examine the reporting of meta-analyses of observational studies and to make recommendations to aid authors, reviewers, editors, and readers. Twenty-seven participants were selected by a steering committee, based on expertise in clinical practice, trials, statistics, epidemiology, social sciences, and biomedical editing. Deliberations of the workshop were open to other interested scientists. Funding for this activity was provided by the Centers for Disease Control and Prevention. We conducted a systematic review of the published literature on the conduct and reporting of meta-analyses in observational studies using MEDLINE, Educational Research Information Center (ERIC), PsycLIT, and the Current Index to Statistics. We also examined reference lists of the 32 studies retrieved and contacted experts in the field. Participants were assigned to small-group discussions on the subjects of bias, searching and abstracting, heterogeneity, study categorization, and statistical methods. From the material presented at the workshop, the authors developed a checklist summarizing recommendations for reporting meta-analyses of observational studies. The checklist and supporting evidence were circulated to all conference attendees and additional experts. All suggestions for revisions were addressed. The proposed checklist contains specifications for reporting of meta-analyses of observational studies in epidemiology, including background, search strategy, methods, results, discussion, and conclusion. Use of the checklist should improve the usefulness of meta-analyses for authors, reviewers, editors, readers, and decision makers. An evaluation plan is suggested and research areas are explored.
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            Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients

            Among patients with aortic stenosis who are at intermediate or high risk for death with surgery, major outcomes are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. There is insufficient evidence regarding the comparison of the two procedures in patients who are at low risk.
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              Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients

              Transcatheter aortic-valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis who are at increased risk for death from surgery; less is known about TAVR in low-risk patients.
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                Author and article information

                Contributors
                Journal
                Europace
                Europace
                europace
                Europace
                Oxford University Press
                1099-5129
                1532-2092
                July 2022
                09 February 2022
                09 February 2022
                : 24
                : 7
                : 1127-1136
                Affiliations
                Department of Cardiovascular and Thoracic Sciences, Università Cattolica del Sacro Cuore , L.go A. Gemelli 1, 00168 Rome, Italy
                Department of Cardiovascular and Thoracic Sciences, Università Cattolica del Sacro Cuore , L.go A. Gemelli 1, 00168 Rome, Italy
                Department of Cardiovascular and Thoracic Sciences, Università Cattolica del Sacro Cuore , L.go A. Gemelli 1, 00168 Rome, Italy
                Department of Cardiovascular and Thoracic Sciences, Università Cattolica del Sacro Cuore , L.go A. Gemelli 1, 00168 Rome, Italy
                Department of Cardiovascular Medicine, Fondazione Policlinico Universitario A. Gemelli IRCCS , Rome, Italy
                Department of Cardiovascular and Thoracic Sciences, Università Cattolica del Sacro Cuore , L.go A. Gemelli 1, 00168 Rome, Italy
                Department of Cardiovascular Medicine, Fondazione Policlinico Universitario A. Gemelli IRCCS , Rome, Italy
                Department of Cardiovascular and Thoracic Sciences, Università Cattolica del Sacro Cuore , L.go A. Gemelli 1, 00168 Rome, Italy
                Department of Cardiovascular Medicine, Fondazione Policlinico Universitario A. Gemelli IRCCS , Rome, Italy
                Department of Cardiovascular and Thoracic Sciences, Università Cattolica del Sacro Cuore , L.go A. Gemelli 1, 00168 Rome, Italy
                Department of Cardiovascular Medicine, Fondazione Policlinico Universitario A. Gemelli IRCCS , Rome, Italy
                Department of Cardiovascular and Thoracic Sciences, Università Cattolica del Sacro Cuore , L.go A. Gemelli 1, 00168 Rome, Italy
                Department of Cardiovascular Medicine, Fondazione Policlinico Universitario A. Gemelli IRCCS , Rome, Italy
                Department of Cardiovascular and Thoracic Sciences, Università Cattolica del Sacro Cuore , L.go A. Gemelli 1, 00168 Rome, Italy
                Department of Cardiovascular Medicine, Fondazione Policlinico Universitario A. Gemelli IRCCS , Rome, Italy
                Department of Cardiovascular and Thoracic Sciences, Università Cattolica del Sacro Cuore , L.go A. Gemelli 1, 00168 Rome, Italy
                Department of Cardiovascular Medicine, Fondazione Policlinico Universitario A. Gemelli IRCCS , Rome, Italy
                Department of Cardiovascular and Thoracic Sciences, Università Cattolica del Sacro Cuore , L.go A. Gemelli 1, 00168 Rome, Italy
                Department of Cardiovascular Medicine, Fondazione Policlinico Universitario A. Gemelli IRCCS , Rome, Italy
                Department of Cardiovascular and Thoracic Sciences, Università Cattolica del Sacro Cuore , L.go A. Gemelli 1, 00168 Rome, Italy
                Department of Cardiovascular Medicine, Fondazione Policlinico Universitario A. Gemelli IRCCS , Rome, Italy
                Author notes
                Corresponding author. Tel: +39 063 015 5950. E-mail address: francesco.burzotta@ 123456unicatt.it
                Author information
                https://orcid.org/0000-0002-4045-2859
                https://orcid.org/0000-0001-5577-081X
                https://orcid.org/0000-0001-6391-422X
                https://orcid.org/0000-0003-1611-7708
                https://orcid.org/0000-0001-9777-013X
                https://orcid.org/0000-0002-6569-9401
                https://orcid.org/0000-0002-9482-411X
                Article
                euac008
                10.1093/europace/euac008
                9460982
                35138367
                711ca1ac-b3c2-45f7-8e4c-2ba4a3294d3e
                © The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 23 October 2021
                : 18 January 2022
                : 27 January 2022
                Page count
                Pages: 10
                Categories
                Clinical Research
                Pacing and Cardiac Resynchronization Therapy
                AcademicSubjects/MED00200

                Cardiovascular Medicine
                permanent pacemaker implantation,transcatheter aortic valve implantation,transcatheter aortic valve replacement,clinical outcome,personalized medicine,meta-analysis

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