Dataset Information

Cardiac implant registries 2006-2016: a systematic review and summary of global experiences.

ABSTRACT:

Objectives

The importance of Cardiac Implant Registry (CIR) for ensuring a long-term follow-up in postmarket surveillance has been recognised and approved, but there is lack of consensus standards on how to establish a CIR. The aim of this study is to investigate the structure and key elements of CIRs in the past decade (2006-2016) and to provide recommendations on 'best practice' approaches.

Settings and participants

A systematic search on CIR was employed in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The following databases were searched: the PubMed (Medline), ScienceDirect and the Scopus database, EMBASE. After identifying the existing CIRs, an aggregative approach will be used to explore key elements emerging in the identified registries.

Results

The following 82 registries were identified: 18 implantable cardioverterdefibrillator (ICD) registries, 7 cardiac resynchronisation therapy (CRT) registries, 5 pacemaker registries and 6 cardiovascular implantable electronic device registries which combined ICD, pacemaker and CRT implantation data; as well as 22 coronary stent registries and 24 transcatheteraortic heart valve implantation registries. While 71 national or local registries are from a single country, 44 are from European countries and 9 are located in USA. The following criteria have been summarised from the identified registries, including: registry working group, ethic issues, transparency, research objective, inclusion criteria, compulsory participation, endpoint, sample size, data collection basement, data collection methods, data entry, data validation and statistical analysis.

Conclusions

Registries provide a 'real-world' picture for patients, physicians, manufacturers, payers, decision-makers and other stakeholders. CIRs are important for regulatory decisions concerning the safety and therefore approval issues of the medical device; for payers CIRs provide evidence on the medical device benefit and drive the decision whether the product should be reimbursed or not; for hospitals CIRs' data are important for sound procurement decisions, and CIRs also help patients and their physicians to joint decision-making which of the products is the most appropriate.

SUBMITTER: Zhang S

PROVIDER: S-EPMC5898296 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Publications

Cardiac implant registries 2006-2016: a systematic review and summary of global experiences.

Zhang Shixuan S Gaiser Sebastian S Kolominsky-Rabas Peter L PL

BMJ open 20180412 4

<h4>Objectives</h4>The importance of Cardiac Implant Registry (CIR) for ensuring a long-term follow-up in postmarket surveillance has been recognised and approved, but there is lack of consensus standards on how to establish a CIR. The aim of this study is to investigate the structure and key elements of CIRs in the past decade (2006-2016) and to provide recommendations on 'best practice' approaches.<h4>Settings and participants</h4>A systematic search on CIR was employed in line with the Prefer ...[more]

PMID: 29654008

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Project description:BackgroundNational cardiac registries are increasingly used for informing health policy, improving the quality and cost-effectiveness of patient care, clinical research, and monitoring the safety of novel treatments. However, the quality of registries is variable. We aimed to assess the characteristics and quality of national cardiac registries across all subspecialties of cardiac care.MethodsPublications relating to national cardiac registries across six cardiac subspecialty domains were identified by searching MEDLINE and the Google advanced search function with 26 438 citations and 4812 full-text articles reviewed.ResultsA total of 155 registries, representing 49 countries, were included in the study. Of these, 45 related to coronary disease or percutaneous coronary intervention, 28 related to devices, arrhythmia, and electrophysiology, 24 related to heart failure, transplant, and mechanical support, 21 related to structural heart disease, 21 related to congenital heart disease, and 16 related to cardiac surgery. Enrollment was procedure-based in 60% and disease-based in 40%. A total of 73.10 million patients were estimated to have been enrolled in cardiac registries. Quality scoring was performed using a validated registry grading system, with registries performing best in the use of explicit variable definitions and worst in assessment of data reliability. Higher quality scores were associated with government funding, mandated enrollment, linkage to other registries, and outcome risk adjustment. Quality scores and number of registries within a country were positively correlated with each other and with measures of national economic output, health expenditure, and urbanization.ConclusionsThere has been remarkable growth in the uptake of national cardiac registries across the last few decades. However, the quality of processes used to ensure data completeness and accuracy remain variable and few countries have integrated registries covering multiple subspecialty domains. Clinicians, funders, and health policymakers should be encouraged to focus on the range, quality, and integration of these registries. Registration: URL: https://www.crd.york.ac.uk/prospero; Unique identifier: CRD42020204224.

Project description:ObjectivesThe objective of this systematic review was to examine the existing evidence base for the cost-effectiveness or cost-benefit of clinical quality registries (CQRs).DesignSystematic review and narrative synthesis.Data sourcesNine electronic bibliographic databases, including MEDLINE, EMBASE and CENTRAL, in the period from January 2000 to August 2019.Eligibility criteriaAny peer-reviewed published study or grey literature in English which had reported on an economic evaluation of one or more CQRs.Data extraction and synthesisData were screened, extracted and appraised by two independent reviewers. A narrative synthesis was performed around key attributes of each CQR and on key patient outcomes or changes to healthcare processes or utilisation. A narrative synthesis of the cost-effectiveness associated with CQRs was also conducted. The primary outcome was cost-effectiveness, in terms of the estimated incremental cost-effectiveness ratio (ICER), cost savings or return-on-investment (ROI) attributed to CQR implementation.ResultsThree studies and one government report met the inclusion criteria for the review. A study of the National Surgical Quality Improvement Programme (NSQIP) in the USA found that the cost-effectiveness of this registry improved over time, based on an ICER of US$8312 per postoperative event avoided. A separate study in Canada estimated the ROI to be US$3.43 per US$1.00 invested in the NSQIP. An evaluation of a post-splenectomy CQR in Australia estimated that registry cost-effectiveness improved from US$234?329 to US$18?358 per life year gained when considering the benefits accrued over the lifetime of the population. The government report evaluating five Australian CQRs estimated an overall return of 1.6-5.5 times the cost of investment.ConclusionsAvailable data indicate that CQRs can be cost-effective and can lead to significant returns on investment. It is clear that further studies that evaluate the economic and clinical impacts of CQRs are necessary.Prospero registration numberCRD42018116807.

Project description:ObjectiveCardiac disease in pregnancy is a leading cause of maternal death in high-income countries. Evidence-based guidelines to assist in planning and managing the healthcare of affected women is lacking. The objective of this research was to produce the first qualitative metasynthesis of the experiences of pregnant women with existing or acquired cardiac disease to inform improved healthcare services.MethodWe conducted a systematic search of peer-reviewed publications in five databases to investigate the decision-making processes, supportive strategies and healthcare experiences of pregnant women with existing or acquired cardiac disease, or of affected women contemplating pregnancy. Identified publications were screened for duplication and eligibility against selection criteria, following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We then undertook a thematic analysis of the data relating to women's experiences extracted from each publication to inform new healthcare practices and communication.ResultsEleven studies from six countries were included in our meta-synthesis. Four themes were revealed. Women with congenital and acquired heart disease identified situations where they had either taken charge of decision-making, lacked control or experienced emotional uncertainty when making decisions. Some women were risk aware and determined to take care of themselves in pregnancy while others downplayed the risks. Women with heart disease acknowledged the importance of specific social support measures during pregnancy and after child birth, and reported a spectrum of healthcare experiences.ConclusionsThere is a lack of integrated and tailored healthcare services and information for women with cardiac disease in pregnancy. The experiences of women synthesised in this research has the potential to inform new evidence-based guidelines to support the decision-making needs of women with cardiac disease in pregnancy. Shared decision-making must consider communication across the clinical team. However, coordinated care is challenging due to the different specialists involved and the limited clinical evidence concerning effective approaches to managing such complex care.

Dataset Information

Cardiac implant registries 2006-2016: a systematic review and summary of global experiences.

Objectives

Settings and participants

Results

Conclusions

Publications

Cardiac implant registries 2006-2016: a systematic review and summary of global experiences.

Similar Datasets

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