Databases and registries recording the usage of cardiovascular implantable medical devices: A rapid review of the literature

Abstract

Background

Implantable Medical Devices (IMDs) are essential for ensuring the quality of life in patients. They also play a crucial role in terms of the costs associated with surgical procedures, as well as incurring potential risks requiring continuous monitoring following implantation.

Objective

The aim of this systematic review of public health intervention was to determine which countries collect data on the utilization of implantable cardiovascular medical devices (IMD-Cs), and how countries record the captured data. We identified parameters for comparing the use of IMD-Cs among countries that could serve as an example for Latin American countries.

Method

A Rapid Systematic Review of the literature through a survey using three search engines was carried out between July and August 2024. Eligible studies measured the annual use of IMD-Cs based on nationwide data published between January 2014 and August 2024. Data were synthesized using tables and an analytical approach.

Results

From 1602 identified publications, 23 studies measuring the use of IMD-Cs were selected. This made it possible to map the sites where national records repositories are located and the type of data held therein.

Conclusions

Many countries collect countrywide information on IMD-Cs and use a variety of methods to register/record the data. There are substantial advantages for a country with IMD-C registries, including monitoring access to IMD-Cs; tracking the costs of the devices; assessing the levels of incorporation of relevant new technologies; and helping improve medical and nursing protocols.

Graphical abstract.

This is a visual representation of the abstract.

Introduction

An implantable medical device (IMD) is defined as a medical product designed to be inserted into the human body for a period of 30 days or more, or to replace an epithelial surface, provided that it is neither a drug nor a biological product. ¹

These devices encompass a broad spectrum of products, from intraocular lenses to hip prostheses and life-sustaining technologies such as pacemakers, heart valves, and defibrillators. Their adoption has grown steadily, playing an important role in preserving and enhancing patient health across multiple medical fields. ²

Cardiac implant registries constitute important tools for strengthening public health systems. ³ By enabling systematic data collection, longitudinal surveillance, and outcomes evaluation, such registries support evidence-based decision-making, quality assurance, and post-market monitoring. Public health interventions involve coordinated actions aimed at protecting, promoting, and restoring population health. For interventions associated with long-term outcomes, such as cardiac implants, continuous follow-up is essential to assess safety, effectiveness, and resource use.

Brazil currently lacks a comprehensive national repository dedicated to IMD-C data. In this context, analyzing international experiences in collecting and managing IMD-C information is of strategic relevance. Comparative assessment can identify best practices in governance, data standardization, and transparency that may inform domestic health policy development.

Accordingly, this rapid literature review (RLR) aimed to: (i) Map national IMD-C databases described in the scientific literature over the past 10 years; (ii) identify countries of device origin; (iii) compile website addresses of repositories; and (iv) evaluate the granularity of recorded data, while generating parameters to support future development of a national Brazilian repository.

Method

We conducted a RLR—a streamlined process designed to respond to research questions by synthesizing existing data which can be completed within shorter timeframes than a Systematic Literature Review (SLR), while maintaining a similar level of transparency, replicability, and minimal bias. RLRs basically enable a simplified version of conventional SLRs by “producing evidence in a quicker and more resource-efficient manner.” ⁴

A RLR is iterative, requiring ongoing review, documentation, and stakeholder validation, with decisions recorded in the final report.

The RLR methodology can be structured in a two-stage general framework comprising seven sub-steps. The first is the planning stage consisting of four sub-steps: (i) Formulate the research question; (ii) define keywords; (iii) define the search strategy; and (iv) define the data extraction methodology. The second stage is the execution stage, with three sub-steps: (i) Selection of relevant studies; (ii) data extraction and quality assessment; and (iii) reporting results. The sequence of activities at each stage and the respective sub-steps are illustrated in Figure 1.

Figure 1.

Rapid literature review stages. Compiled by the Authors.

As for a verification protocol, our research included the following activities at each stage of the work, as recommended by experts familiar with the adoption of the RLR approach: (i) A survey of titles, “double checking” of titles and abstracts by two researchers in 5% of the studies in order to determine their eligibility for inclusion; (ii) selection of the “full” texts by a single researcher; (iii) a second check of data extracted from 20% of the studies; and (iv) an assessment of the quality of the study by an expert.

The methodological roadmap is recorded on the Zenodo platform under the Digital Object Identifier (DOI): 10.5281/zenodo.14014770.

Search strategy

The research was structured in the form of a RLR focused on two questions:

1. Are there any national databases and indicators that could be adopted to serve as an example and parameter for stakeholders (doctors, health managers, industry and distributors) in Brazil's cardiological medical devices industry?

2. What aspects are considered in the scientific reference literature for analyzing the level of use or access to IMDs to treat cardiovascular issues?

With the support of experienced researchers, a comprehensive search strategy was developed to identify published articles that might provide answers to the above questions.

Structured search strategies were used in database searches and constructed using PubMed MeSH terms and Boolean operators. The following databases were researched: PubMed, Google Scholar, and IEEE Xplore.

Period: From 2014 to 2024

MedLine and Embase (PubMed): (implantable medical device) AND (national statistics) NOT (contraceptive AND tooth AND dental AND breast AND arthroplasty AND contraceptive AND hip AND joint AND spine AND knee AND neck AND shoulder AND ankle) = // 960 results.

IEEE Xplorer: “Abstract”: “implantable medical devices” AND (“Full Text & Metadata”: statistics)

Filters Applied: Journals Conferences Books = 26 results

Google Scholar: “Implantable medical device” AND national statistics. NOT (contraceptive AND tooth AND dental AND breast AND arthroplasty AND contraceptive AND hip AND joint AND spine AND knee AND neck AND shoulder AND ankle) = 622 Results

The searches (in August 2024) were carried out in: PUBMED (August 2014, and the first week of 2024); GoogleScholar (August 2014, and the second week of 2024); IEEXplore (August 2014, and the third week of 2024). References to relevant systematic reviews were also checked.

Inclusion and exclusion criteria

A total of 23 primary research studies using experimental or observational study designs to measure national use of IMD-Cs (published in English in 2014) were included. Inclusion and exclusion criteria were defined at the beginning of the review.

The inclusion criteria were: (a) Primary and secondary studies; and (b) articles that directly or indirectly answered the research questions. Articles that addressed both criteria were included, such as studies referring to coefficients of heart disease-related IMDs, as well as information sourced from national and intercontinental professional association databases. Conference reports, letters, and editorials were excluded, as were cohort studies (i.e., epidemiological-type observational studies aimed at observing a previously defined population, such as in a hospital or group of hospitals—or even in an entire country—to estimate the incidence of a specific disease or other health or disease-related phenomena). These studies were excluded because most cohort studies are reckoned to cover continuous periods with no clear timescale identification, such as the year when carried out, and are often not done on a national scale but focus on smaller samples.

Study selection

Title and abstract screening were tested concurrently but independently by three researchers (PVM, MLD, MLS) of 5% of the registries. Decisions were compared and discussed to resolve inconsistencies before proceeding further. Titles and abstracts of the remaining 95% of registries were next reviewed by a single researcher (PVM). The “full” texts of all the articles identified as potentially relevant were retrieved, and their eligibility assessed in line with the inclusion and exclusion criteria (by PVM). This process was revisited in 20% of cases (MLS), and any studies that raised doubts regarding their inclusion were reviewed (by PVM) and submitted for a second review (by MLD and MLS) in conformity with the review criteria. The selection process was aided by using Excel spreadsheets. The PRISMA flowchart below (Figure 2) shows the results of the research, and the process of selection and eligibility of studies identified via databases and registers for inclusion in the study.

Figure 2.

PRISMA flowchart with research results, selection process and eligibility of studies for inclusion. Source: Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: An updated guideline for reporting systematic reviews. BMJ 2021;372: n71. doi: 10.1136/bmj. n71. More details at: http://www.prisma-statement.org/.

Data extraction and synthesis

A data extraction form was developed and tested. This form contained summarized information about the extracted study, such as author, country, period and details of the database used for sourcing usage data.

Key data from articles selected for inclusion in the rapid review were noted by researchers using a data recording form (similar to the data extraction forms used in systematic reviews).

Data recording involved analyzing and classifying data according to key aspects or concepts, including the following: (i) Whether the article was assessed; (ii) whether the article was selected or excluded; (iii) reason for selection or exclusion; (iv) key results; and (v) conclusion. Variables used (e.g. data sources) to support the findings or assertions were also recorded when available. Non-available data for a specific category was recorded in the extraction table as “not reported.”

The “included” studies were identified according to the availability of annual data and territories with comparable populations. The 23 selected articles contained references to one or more of the following IMD-Cs:

• Pacemaker (CRT-P): A device that improves the rhythm and coordination of the heart by sending electrical impulses to the ventricles.

• Defibrillator (CRT-D): A pacemaker that also includes a defibrillator function to correct potentially fatal arrhythmias while synchronizing the heartbeat.

• Implantable cardioverter-defibrillator (ICD): A device implanted in the chest to monitor heart rhythm and deliver shocks to correct abnormal heartbeats.

• Left ventricular assist devices (LVADs): Mechanical pumps designed to help the left ventricle pump blood in individuals with heart failure.

• Transcatheter aortic valve replacement (TAVI): Aortic valve replaces the damaged original valve using a catheter.

• Mitral valve (TMVR): Mitral valve replacement using a catheter without open-heart surgery.

• Drug-eluting and bare metal stents: Small tubes placed in the arteries to keep them open. Drug-eluting stents release medication to prevent blockages and bare metal stents provide structural support without medication.

Data on total population use and other details collected from each of the 23 selected studies were summarized for one or more of the seven IMD-Cs described above (see Tables 1 to 3).

Table 1.

Institutions with IMD-C usage registration systems, by author.

Author	Country	Period	Platforms with records
Begisbayev, 2022 5	Kazakhstan	2004–2016	The electronic database from the Unified Healthcare Information System within the GVFMC and the CSMI system
Bonny et al., 2018 6	Africa	2017–2019	The Cardiac Arrhythmia and Pacing Task Forces of the PASCAR
Cano Perez, 2019 7	Spain	2000–2017	EPPIC submitted to the National Pacemaker Databank of Spain. www.cardiodispósitos.es
Cheng et al., 2022 27	China	2018	NCCQI database. NCCQI was established by the National Center for Cardiovascular Diseases under the guidance of the National Health Commission of the People's Republic of China
Chung, 2021 21	Taiwan	2012–2017	NHIRD Database = 93% of healthcare facilities in Taiwan
Dehmer et al., 2016 8	USA	Registration	National Cardiovascular Data Registry Voluntary Public Reporting Program
Dilaveris, 2020 9	Greece	2003–2013	European Heart Rhythm Association
Hosseini et al., 2017 10	USA	2017	NIS, HCUP, and AHRQ. The NIS represents approximately 20% of all discharges from a broad spectrum of US hospitals. National estimates can be calculated using sampling weights provided by the NIS.
Johal, 2024 11	USA	2013	NIS, HCUP
Joshi, 2019 25	USA	2008–2017	NIS, HCUP
Kawsara, 2020 26	USA	2008–2016	National Readmission Database
Lee et al., 2014 12	South Korea	2007	NHI
Lai, 2015 22	Taiwan	2007–2009	NHI claims database, Taiwan. The Bureau of NHI (currently theNHIA) implemented the compulsory universal NHI program in Taiwan since 1995. More than 98% of the total Taiwanese population of 23 million is covered by the program.
Lindvall, 2016 13	USA	2017–2019	NIS
Mack, 2021 14	USA	2014–2019	Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry
Masoudi, 2017 23	USA	2014	National Cardiovascular Data Registry hospital quality programs: (1) CathPCI (Diagnostic Catheterization and Percutaneous Coronary Intervention) for coronary angiography and percutaneous coronary intervention; (2) ICD Registry for implantable cardioverter-defibrillators; (3) ACTION-GWTG for acute coronary syndromes; and (4) IMPACT for cardiac catheterization and intervention for pediatric and adult congenital heart disease
Mukdad et al., 2018 15	USA	2010–2014	National Readmissions Database, 2010–2014
Oettinger, 2023 16	Germany	2011–2016	Research Data Center of the Federal Bureau of Statistics (DESTATIS)
Raatikainen, 2015 17	Europe	2006–2012	EHRA
Sanaiha, 2020 24	USA	2001–2021	NIS
Sanaiha, 2021 18	USA	2019–2021	NIS
Timmis et al., 2020 19	Europe	2008–2017	ESC Atlas of Cardiology that is compiled and regularly updated by the European Heart Agency in Brussels.
Zecchin. 2024 20	Italy	2017–2020	Italian hospital discharge records related to PM/ICD procedures in the National Institute of Health

Compiled by Authors. ICD-10: International Classification of Diseases; NIS: Nationwide Inpatient Sample; NHIA: National Health Insurance Administration; NHI: National Health Insurance; EHRA: European Heart Rhythm Association; CSMI: Compulsory Social Medical Insurance; GVFMC: Guaranteed Volume of Free Medical Care; EPPIC: European Patient Identification Card; NCCQI: National Center for Cardiovascular Quality Improvement; HCUP: Healthcare Cost and Utilization Project; AHRQ: Agency for Healthcare Research and Quality; NIS: National Inpatient Sample; ACTION-GWTG: acute coronary treatment and intervention outcomes network-get with the guidelines; IMPACT: improving pediatric and adult congenital treatment.

Table 2.

Mapping of data available in national records on the utilization of cardiac implantable medical devices in selected articles—general data and main segments by author and type of usage.

Product Data by author	Pacemaker (CRT-P)	Defibrillator (CRT-D)	ICD	LVADs	TAVI	Mitral valve (TMVR)	Drug-eluting and bare metal stents
Countries	Africa; Spain; Greece; USA; Europe; Italy; China	Africa; Greece; USA; Europe; China	Kazakhstan; Africa; Greece; Europe; Italy and China	Europe and USA	Taiwan; USA and Europe	USA	Taiwan and Germany
General Data: Total usage in units or divided by population (author)	(6); (7); (9); (10); (26); (17); (19); (20); (27)	(6); (9); (10); (11); (13); (23); (17); (19); (27)	(5); (6); (9); (17); (19); (20); (27)	(25) ;(24); (18); (19)	(21); (26); (19)	(14)	(22); (16)
Usage by age (author)	(7); (10)	(10); (23)	(5)	NA	(21)	NA	(22)
Usage by gender (author)	(10)	(10); (11) and (23)	(5)	(25); (24)	NA	(14)	(22); (16)
Use by ethnicity (author)	NA	(11)	NA	(25); (24)	NA	(14)	NA
Usage by average income (author)	NA	(11)	NA	(25); (24); (18)	NA	NA	NA
Regional utilization within the country (author)	(7); (17); (27)	(11); (13); (23); (17); (27)	(5); (17); (27)	(25); (24); (18)	NA	(14)	NA
Usage by hospital size (small/medium/large) (author)	(27)	(11); (27)	(27)	(24); (18)	NA	NA	NA
Use for primary implant and replacement (author)	(7); (20)	NA	(20)	NA	NA	NA	NA

Compiled by the Authors. NA: not available; ICD: implantable cardioverter-defibrillator; LVAD: left ventricular assist devices; TAVI: transcatheter aortic valve replacement; PASCAR: Pan-African Society of Cardiology.

Table 3.

Mapping of data available in national records of cardiac implantable medical devices in selected articles.

Product Data by author	Pacemaker (CRT-P)	Defibrillator (CRT-D)	ICD	LVADs	TAVI	Mitral valve (TMVR)	Drug-eluting and bare metal stents
Disease incidence by ICD-10	(7); (10); (20)	(10); (11); (13)	(5)	(25)	(21)	NA	(16)
Pre-existing comorbidities	(26)	(13); (23)	NA	(25)	(21); (26)	NA	(22)
Number of health centers (hospitals and others)	(17); (19); (27)	(6); (10); (23); (17); (19); (27)	(5); (6); (17); (19); (27)	(24); (18)	(19)	NA	(16)
Access to diagnostic tests	(19)	(19)	(19)	(19)	(19)	NA	NA
Post-implantation medications	NA	(23)	NA	NA	NA	NA	(22)
Manufacturers	(6)	(6)	(6)	NA	NA	NA	NA
Rate of complications/adverse effects	(10); (26)	(10)	NA	(25); (24)	(26)	(14)	NA
Mortality rate	NA	(23)	NA	(25); (24); (18)	NA	(14)	(22); (16)
Records of the impact on health system costs
Value	(26)	(13)	NA	(18)	(26)	NA	(16)
Length of hospital stay by days of hospitalization	(10); (26)	(10)	(5)	(25); (18)	(26)	NA	(16)
Paying agent	NA	(11); (13); (23)	NA	(25); (24); (18)	NA	NA	NA

Additional data and compilation by the Authors. NA: not available; ICD: implantable cardioverter-defibrillator; LVAD: left ventricular assist devices; TAVI: transcatheter aortic valve replacement.

Results

Twenty-three studies that measured the use of IMD-Cs on an annual basis were selected. Of these, 17 studies—in direct response to the pertinent research question—contained data from the annual reports on national use of the products (Figure 3).^5–20

Figure 3.

Records of cardiovascular implantable medical devices’ usage: A rapid literature review. Compiled by the Authors.

Six studies,^21–26 exploring other related issues, such as outcomes, mortality or post-use readmissions, were selected because they provided annual national data on utilization.

The article by Cheng et al. ²⁷ can be considered as the 24th study, but it was not identified by the search strings in the literature review. It is included in the tables of this RLR as it provides the research response for China. It was identified by Zecchin et al ²⁰ in the reading of the full texts.

Table 1 lists the authors, countries, periods, and databases identified in this RLR and identifies the websites where the national repositories of the selected articles are registered. Detailed data or short notes on the use of IMD-Cs contained in the same articles are alluded to in Tables 2 and 3.

Table 2 presents the key details identified by the author and data mapping related to the national use of IMD-Cs in the selected articles. The table goes on to provide general data and the main segments of the articles, such as: (i) Total use of IMD-Cs, either in units or by population; (ii) use by age, gender, ethnicity, average income; (iii) use at regional level in a country; (iv) use according to hospital size (small, medium and large); and (v) distinction between data on the use of primary implants and replacements of cardiovascular implants.

Table 3 presents a mapping of the additional data related to the national use of IMDs for cardiological use, identified in the selected articles by author name. The data include, for example, incidence of the disease by the International Classification of Diseases (ICD-10), preexisting comorbidities, number of care centers (hospitals and others), access to diagnostic tests, post-implantation medication, names of manufacturers, rates of complications or adverse effects, mortality rate, costs to the health system, value and length of hospital stay (in days), and the paying agent.

Comments

Reasons for data collection: While analyzing the texts, a number of motivations or objectives were identified regarding why different countries collected data on the number of IMD-C implants. We concluded that the main motivation for a country to undertake this task is evidently its need to obtain information on per capita access to IMD-C implants, and to compare access with indicators from other countries.

Other motivations were also detected in our search such as: (i) The need to analyze the cost-effectiveness of products; (ii) the requirement to consider the speed with which new technologies were being incorporated, and to review IMD-C reimbursement lists; (iii) to understand and address national (i.e. internal) barriers to the incorporation of products, such as differing levels of access to diagnostic tests, levels of appropriate training for health professionals, economic factors, and the quality of governance of a country's health system; (iv) the need to focus on the best criteria for introducing protocols for product selection according to a patient's health profile and condition; (v) the need for post-implant follow-up to observe occurrences of post-implant complications and/or other adverse effects; and (vi) to analyze positive developments in the growing IMD-C market.

Use of data in predictive analysis: The use of statistical data for forecasts of hospital readmissions and mortality, ¹⁴ and analyses of future usage trends^23,24

Ownership of data registry platforms: Data are often collected from platforms owned by “unified” national health systems, such as the Nationwide Inpatient Sample (NIS) in the United States, ¹⁰ the National Readmissions Database ¹⁵ also in the United States, and the National Health Insurance Administration (NHIA) in Taiwan, ²² the National Health Insurance (NHI) in South Korea, ¹² the Data Center of Germany's Federal Statistical Office (DESTATIS) ¹⁶ and Italy's Hospital Discharge Database. ¹²

Some countries with unified general registries have also developed “dedicated platforms” for collecting detailed IMD-C data. Such platforms involve cardiology associations and collaboration with local manufacturers and distributors to check the quality of the data registries where they are located. This is the case of, for example, the online platform Cardiodispositivos.es in Spain, ⁷ and the National Cardiovascular Data Registry (NCDR) in the United States. ⁸

Some organizations collect data at “continental” level, as is the case for Europe and Africa. In Africa, according to a study by Bonny et al. ⁶ and Europe, the European Heart Rhythm Association (EHRA) has been collecting data since 2008^17,19 from which several intra-area comparative studies have emerged.

In addition to the 23 selected articles, it is worth mentioning Zhang, ²⁸ whose SLR contains a list of websites with details of registries that record the use of IMD-C implants.

Platforms with open data (public access) compared with data platforms restricted to professionals. Most platforms focus on professionals in the field of hospital care and cardiology, apart from the American platform NCDR, where patients can search the aggregated data by themselves.

Voluntary and mandatory registries: Proprietary registries are mainly voluntary with their own sampling bases. However, they hold a large amount of detailed data, which allows for a statistical extrapolation/projection of population size (i.e. Assuming that past trends will continue). Mandatory registries include Taiwan's NHIA.

The impact of demography on per capita implant results: The average age of a country's population impacts the results of IMD-C per capita implant indicators. Countries with younger populations, such as those in Africa, tend to have lower per capita implant rates, as well as less access to the related medical facilities. Given such anomalies, it is suggested that comparison indicators should normally only be used between countries with similar population pyramids that show, for example, the distribution of a population by age, gender, access to health facilities, etc.

Impact of “out of pocket” purchases of IMD-Cs: In the course of our survey, we found comments that out-of-pocket purchases of IMD-Cs could lead to under-identification or under-registration of access.

Analysis of the availability of health services required for the implantation of IMD-Cs: In several studies, we found estimates of the number of health centers and doctors specializing in implants. Estimates of the size of these institutions were also available, together with their regional distribution within countries concerned with broadening national access and the need for improvements in health care in general and especially Home Health Care. ²³

Clinical implications and recommendations for clinicians: Medical devices differ from pharmaceuticals, and their regulatory pathways are likewise distinct. Nevertheless, for both clinicians and patients, the central consideration is the demonstration of clear health benefits that outweigh potential risks. ²⁹ In this context, estimating the utilization of implantable cardiac medical devices (IMD-Cs) is essential to determine whether populations have adequate access to guideline-recommended therapies. Evaluating both the frequency and duration of use yields important insights into treatment patterns, continuity of care, and real-world effectiveness. Translating knowledge derived from healthcare databases into practice can generate meaningful clinical implications, including the reduction of adverse events such as infections, thrombosis, device malfunction, and problems related to patient adherence.

Systematic monitoring can also mitigate risks associated with device miscalibrations such as in cardiac resynchronization systems—and enable earlier detection of post-implantation complications. Beyond safety, robust data systems support the development of new techniques and clinical protocols, foster innovation, enable comparative effectiveness research, and strengthen post-market surveillance. These functions contribute to more comprehensive patient assessment and can help achieve sustainably lower healthcare costs. ³⁰

Such data can serve multiple strategic purposes, including market surveillance, optimization of clinical protocols, and the formulation of prevention and treatment policies. Active participation in and adherence of clinicians to structured device registries and databases further enhance clinical outcomes and inform evidence-based health policy decisions. Together, these applications underscore the value of strong IMD-C data infrastructures for improving clinical decision-making, patient safety, and health system planning.

Conclusions

The RLR revealed that many countries collect national data on IMD-Cs. The review also discovered that there are several ways to register national IMD-C data: Government or private, voluntary or mandatory, open and free, or closed. In the latter case, membership of a cardiology association is required, although there are websites that make data available generally through registration, subscription, and access passwords. The literature shows that there are substantial advantages for a country to maintain registries on data platforms, whether to monitor the evolution of the product costs, keep abreast of the development of new technologies, or to improve their own medicine and nursing protocols, especially those referring to residential care homes for the elderly and the provision of home care more generally.

The development of national cardiac implant usage registries represents a powerful public health intervention, capable of protecting and promoting the health of cardiovascular medical devices (IMD-Cs) implanted patients and can have a wide-reaching impact on their lives.

Brazil, the largest country in Latin America, operates the world's largest universal, free public healthcare system. Despite this scale, the country maintains at least 49 non-integrated healthcare databases, and a fully integrated system encompassing all types of IMDs has not yet been established. ³¹ This fragmentation highlights an important opportunity to strengthen data integration to fully realize the clinical and policy benefits described in this review.