Considerations and Guidance for the Structure Organisation and Operation of Cardiometabolic Prevention Units: A Consensus Statement of the InterAmerican Society of Cardiology

The Specific Challenges of Latin America

Besides the previous issues, which are common worldwide, Latin America (LATAM) has several sociocultural and historical characteristics worth discussing. This is because these specific challenges contribute to what we define as social risk, namely a higher prevalence of CV events and worse outcomes due to economic and social inequity.

Twenty-first century Latin America is the result of multiple mixings of Native Americans, Spanish and other European, African, and, more recently, Asian and Middle Eastern ethno-racial groups [10]. This multiethnic and multicultural mixing took place over the past four centuries, and it consists of different proportions depending on each subregion of the continent, such as Mesoamerica, the Andes, the coast, the Southern Pampas or the Amazon, among many others [10]. This mosaic pattern, which can be found in other regions of the world, is also blended with different proportions of educational, cultural, and socioeconomic conditions [11]. In this regard, various observational and cross-sectional studies have consistently shown that there is a relationship between the emergence of CMRFs –and, eventually, with CVD– and demographic, socioeconomic (schooling, educational level, purchasing power), environmental (habitat, nutrition), cultural factors, and inadequate access to quality healthcare (Figure 1) [11, 12, 13]. Moreover, this socioeconomic reality and its interaction with individuals through history has in turn influenced the expression of the genetic load of human subjects and generates phenotypic manifestations due to epigenetic changes that can be intergenerationally transmitted.

The Whitehall II report is a classic study that assessed the social distribution of central obesity (evaluated using the waist-to-hip ratio) and metabolic syndrome (MS) [14]. The results showed an inverse social gradient, with an increased likelihood of having MS or central obesity among those in the least favourable socioeconomic quintile compared to the those in the top quintile: for central obesity, the increased odds ratio was 2.2 (95% CI: 1.8–2.8) for men and 1.6 (95% CI: 1.1–2.4) for women; for metabolic syndrome, it was 2.2 (95% CI: 1.6–2.9) for men and 2.8 (95% CI: 1.6–4.8) for women.

From the above data, it is clear that, in our setting, it is necessary to guarantee homogeneity in the overall management of CMRFs as well as the access to quality medicine independently of the population’s social stratum. From this setting, we propose that, since CVDs have epidemic behaviour, we must approach them as such. This implies that, if there is an increase in CMD incidence, it merely means that prevention failed. In line with this statement, we must change the paradigm and be more efficient. For this, cardiometabolic prevention (CMP) should be systematically and universally applied and be based on the best available evidence. For instance, randomised clinical trials (RCTs) have provided evidence that therapeutic strategies can reduce the CV risk up to 70% when correctly implemented [15].

In short, CMP entails the accurate application of corrective lifestyle changes and the optimal use of pharmacological treatments to achieve the control of five therapeutic objectives, namely obesity, levels of atherogenic lipoproteins, glucose metabolism, HT, and the prothrombotic state. This approach acknowledges different pathophysiological pathways and identifies therapies that must be considered together, without any hierarchy among them, to achieve an actual reduction in the global risk to provide personalised and precision medicine.

To achieve this ambitious goal, it is necessary to implement a global approach, and this is why the Inter American Society of Cardiology (SIAC) proposes the creation of a network of cardiometabolic prevention units (CMPUs). These are conceived as work units in which a multidisciplinary team works in an integrated and standardised manner based on the best available evidence. The objective is to optimise the diagnosis and degree of control of all CMRFs at once in a comprehensive way, instead of treating them separately and in isolation. Our proposal is for CMPUs to be built on operational and functional concepts, not necessarily implying a single physical space. Their main resource is ‘human,’ and it is paramount that the components of this multidisciplinary team work with well-defined schemes and goals, all under the same standard, have adequate leadership, and also fluent and multilateral communication.

In LATAM, reducing the impact of cardio-metabolic diseases is imperative and why we propose this new way of approaching this epidemic. We believe that the creation of CMPUs may apply to most of the existing health systems of Latin American countries. However, each coordinator will have to make the necessary adjustments to the work system in order to adapt and accommodate each country and community health system. This should be periodically evaluated and make any necessary corrections.

The aim of this Experts’ consensus document written by the IASC is to define how a CMPU should be, as well as its objectives, to propose categories and their minimum requirements, and to recommend an operational scheme that can guide all individuals or centres that, aware of the need for multidisciplinary and standardised work, want to create a unit for the comprehensive management of CMR. Please note that this document does not cover specific targets and therapeutic schemes, since there are many clinical guidelines that deal extensively with the approach to the different CMRFs and each Unit must decide, and periodically update, which guidelines to follow.

Consensus Forming and Content Development

A coordinating committee of 20 experts (including cardiologists, endocrinologists, lipidologists, internists, family physicians, general practitioners, sports therapists, and clinical nutritionists) developed a content index and a list of relevant questions (Online Appendix 1). The panel was organised in balanced working groups that answered the corresponding suggested queries. At a first online discussion meeting, all group members and the corresponding experts prepared a document with potential statements. Afterwards, all the groups met in an in-person meeting to further discuss all questions and answers and prepare the final document. The groups accepted as unanimous those recommendations with a 100% agreement, as consensus, those with at least 80% agreement, and as a discrepancy when there was less than 80% agreement. All the agreed recommendations and conclusions were included in the final report, and a master copy including all the recommendations with arguments for and against was submitted and validated by experts external to the original group in a subsequent last round.

Background Information and Evidence Review

A non-systematic expert literature search was conducted to search for available literature related to each of the questions and using the following search terms: cardiovascular prevention, cardiometabolic prevention, cardiovascular risk, cardiometabolic risk, dyslipidemia, hypertension, diabetes, prediabetes, obesity, metabolic syndrome, cardiometabolic diseases, risk units, and Latin America. The following bibliographic databases were used: PubMed, SciELO, LILACS, Revencyt, BIREME, ScienTI, LIVECS, and PERIODICA. Non-indexed literature and publications from official or international organisations were only selected if the methodology was considered appropriate. Those publications including epidemiological and clinical research data in nota del revisor the applicability of what is recommended to Latin American countries is less well documented estop creo aplica a responder esta inquietud ademas de otros puntos señalados mas abajo- seguir leyendo- LATAM and/or whose conclusions applied to this region were given priority. Lastly, a drafting committee discarded publications in which a potential bias or conflict of interest was identified. After reviewing a total of 65 manuscripts, 29 were used to prepare the consensus statement.

Definition and notion of CMPUs

A CMPU is an operational and functional concept whose main resource is human, so it does not necessarily imply working in a single physical space. The key factor is that those included in the multidisciplinary team work in an integrated manner, all under the same standard, with well-defined objectives, proper leadership, and fluent and multidirectional communication. Hence, it follows that, for instance, depending on the increasing complexity of the different Units (see below), optimal prevention and work can be done from either a small consulting room -with one physician and one nurse or trained and certified medical assistant- or from a more complex CMPU that is integrated into a medical centre, with the possibility of having all human and technological resources at its disposal. Still, it is important that the CMPU is integrated and connected to the health network to allow for the patient’s referral and cross-referral depending on each particular case’s complexity and needs. An additional advantage of belonging to the health network is the current and growing possibility to interact online with other professionals to resolve doubts about the patient’s management straightaway.

One of the challenges of the CMPU team is to integrate their work scheme into each country and community health system. Therefore, it is essential to harmonize with the authorities and the local health system prior to initiating the development of each unit. This will allow working in a coordinated and articulated manner integrated into the existing working procedures without generating frictions and interferences with the other medical community members. These are necessary steps to implement a confident reference system and a counter-referral that will benefit the patient and be more efficient and cost-effective at the end of the day.

Besides medical care, and as an essential part of the CMPU activities, they must develop adequate registry systems with two primary purposes. The first one is to know and self-assess its results and effectiveness. This must include the objective evaluation of the cost effectivity of the integrated UPCM work within the health system and the capability to analise whether the UPCM work provides added value to the current health system. For this, CMPUs must have a common methodology, designed and validated to periodically evaluate whether the goals were achieved in each patient and the population, including the rate of compliance with the therapeutic measures -both pharmacological and non-pharmacological. This way, it is possible to monitor the work done and make timely and necessary corrections of the least effective interventions, analyse how the new work scheme of integrating UPCM and health system could be more efficient in terms of objectives’ achievement and results and, conversely, reinforcing the accurate ones to optimise their work and improve the accomplishment of results. The second essential objective is to generate data that can be used effectively in epidemiological or clinical research. In parallel with this, CMPUs should ideally have, as part of their objectives and to complement their healthcare activity, teaching activities for other health professionals in training, patients, and the community.

An effective CMPU must be an overall objective and go beyond the medical offices or healthcare institutions’ physical space. CMPUs must get involved with the community and seek solutions; the modern notion of health must evolve and expand the scope and, as a consequence, propose and be part of the solution to specific problems. Consistent with this consideration, CMPUs must organise activities that involve the community, which can be educational, investigational, or risk factor screening, among others. These activities must include children and young populations, as it has been recently demonstrated that effective educational interventions and healthy behaviours in children and adolescents have to two major effects: firstly, those healthy habits acquired at an early age are integrated into daily behaviour more reliably and easily, and thus are more effective and durable. Secondly, children can be vectors of change towards their teachers, homes, and the community [18].

As detailed in the following sections, three types of CMPU are proposed, mainly depending on their capacity to manage patients with different complexities and available infrastructure (Table 1). Although overall it is not feasible to define the patients that each type of CMPU can take care of, it is possible to give general rules for the management in each of the types. Generically, as the CMPU increases its capacity (in terms of staff and infrastructure), the patient’s complexity that can be treated increases as well, with CMPU type 3 being the one able to manage the most complex patients.

Requirements of a CMPU

Given the diversity of health systems and each country’s reality from the sociodemographic perspective, this expert panel defined the minimum requirements for each type of Unit (Table 1). Subsequently, each Unit must adapt these requirements to its real world.

CMPU Type 1

Objective: This type of Unit’s fundamental purpose is CV prevention in people at low/moderate risk. However, they can manage other types of patients as long as the characteristics of the health personnel and the infrastructure techniques allow that, and other centres of the area of influence cannot manage complex patients.

The patient can be admitted to CMPU type 1 from:

• Triage (de novo patients), that is, diagnosed in the consultation office itself
• CMRF screening programmes conducted in the community
• Referred by a primary care physician not committed to CV prevention

Minimum required staff: One physician and nursing staff member or medical assistant.

CMPU type 2

Objective: To control overall risk factors in patients at low, moderate, and high risk. We define high risk as two or more risk factors, a difficult to manage risk factor, a patient with target organ injury, or stable after a CV event.

The patient can be admitted to CMPU type 2 from:

• A triage of patients with suspected CV risk (de novo patients) in the absence of a close CMPU type 1.
• A coronary or stroke care unit, or after hospitalisation because of an acute CV or cerebrovascular event.
• Other hospital or clinic services, or nearby Centres or Units, when the diagnosis or specialised control of one or more CV risk factors require a comprehensive and integrated approach.

CMPU type 3

Objective: Type 3 units are more complex and function as specialised reference centres. The priority population are patients with high or very high CV risk that are difficult to manage or who recently had a CV event, including postoperative patients who underwent coronary revascularisation surgery. However, the Unit could admit patients at lower risk if there is no nearby CMPU or they are referred for control and follow-up.

Minimum required staff: In these units, the human resource needs to be the most complex one. The coordinating physician must be a certified cardiologist, although other medical specialists can also be part of the team. Moreover, and in addition to nursing personnel, the Unit must include a clinical nutritionist, a psychologist, and a physical trainer or sports therapist.

Actions to be carried out in each consultation

It is important to bring together activities in the same single visit and, if possible, organise the appointments for other consultations (nutritionist and psychologist, for example) to take place on the same day, as this will help the patient meet the predefined goals. It is also important to note that it is not essential for a physician to visit the patient in all consultations. For instance, visits for test reviews, evaluation of results, weighing, etc. can be completed by an appropriately trained and supervised nurse or medical assistant, as they will be qualified to evaluate results and take the appropriate actions with the support of the medical personnel in the event of any doubt or eventuality. Also, in order to simplify work and reduce overcrowding of medical offices, it is suggested to implement a telemedicine system for follow-up controls and therapeutic orientation.

Key points to keep in mind when stratifying risk

• CV risk is a dynamic process, so it should be periodically assessed when the patient’s clinical conditions change or, ideally, in each follow-up visit.
• New risk factors, such as psychosocial stress and socioeconomic disparity in access to healthcare systems, must be specially considered when managing patients in LATAM and other regions around the world with similar economic characteristics.
• In intermediate-risk patients, who represent a significant group of the population, it is necessary to use other complementary methods to reclassify them into high- or low-risk.
• Since CVD is a process that begins early in life, we believe that, regardless of age, all patient risk must be stratified.

Minimum complementary exams

The completion of complementary exams is essential to assess the CV risk profile. The minimum complementary exams that every CMPU must be able to complete are described below.