The REPLICCAR Registry and The Statewide Quality Improvement Initiative (REPLICCAR)

Paulista Cardiovascular Surgery Registry (REPLICCAR)

Cardiovascular diseases remain the leading cause of death for the healthcare system and cardiac surgery has an important impact on their resolubility. Healthcare systems in the world have evolved to optimize their clinical records and thus learn from the real world through the interactivity between results, processes, and structure. When the rate of growth of healthcare costs scenario is greater than the one of Gross Domestic Product of countries, there is a considerable challenge to increment the quality of healthcare services and the primordial patient safety, as well as the necessary control and traceability of implantable devices. The association and correlation of patients' demographic and clinically relevant information with the resources required for the care provided for each stratum represent the possibility to adapt, improve and innovate the healthcare programs; This will allow improving the optimization of the therapeutic protocols and the creation of related research areas, aiming to promote more equitable resources allocation, increase access and effectiveness, as well as to ascertain the magnitude of available and used resources and its impact.

Study Overview

• Status: Completed
• Conditions: Cardiac Surgical Procedures
• Intervention / Treatment: Procedure: Coronary artery bypass grafting (CABG); Procedure: Heart valve surgery

Detailed Description

METHODS Extension Cohort study, mandatory, prospective multicenter, in the state of São Paulo and of registry of consecutive cases. Besides the situational diagnostic of the results and comparison between the mean of both registries, there will be the creation of improvement reports for each of the REPLICCAR centers.

Next, quality improvement initiatives will be implemented in each center indicated by the reports.

Sample

• Will be included in a consecutive way all patients that had CABG and heart valve surgery in the participant centers for the defined period;
• Data will be collected, independently of surgical volume, severity status, and social condition among others, in sight of the São Paulo state health department;
• This way, it will be possible to produce a predictive curve to be used in most clinical case scenarios observed in the state of São Paulo;

• Study Type: Observational
• Enrollment (Actual): 9723

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05403-900
    • USP Heart Institute
  • São Paulo, Brazil, 05409011
    • Fabio B Jatene, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients (18-90 years old) underwent cardiac surgery.

Description

Inclusion Criteria:

• Age 18- 90 years old.
• CABG or heart valve surgery
• Agreement to participate in the study signing informed consent documentation.

Exclusion Criteria:

• Re-operation
• Impossibility to access data variables relevant to the study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Create and implementing data driven quality initiatives for cardiac surgery procedures in São Paulo state	Guided by the database, quality initiatives will be built in order to reduce mortality, length of stay and complications in the centers participating in REPLICCAR.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Create a morbidity and mortality risk score	Create a morbidity and mortality risk score, in order to guide the care and interventions of patients undergoing cardiac procedures, in order to prevent morbidity and mortality outcomes.	5 years
Long-term follow-up of patients included in the database	Long-term follow-up of patients included in the database, providing an opportunity to assess quality of life, evolution and deaths after hospital discharge.	10 years
Assessment of the impact of patients' socioeconomic variation in its surgical evolution	Assessment of the impact of patients' socioeconomic variation on their evolution in terms of morbidity and mortality (short and long term).	10 years

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Collaborators: Hospital Israelita Albert Einstein; Instituto Dante Pazzanese de Cardiologia; Beneficência Portuguesa de São Paulo; Irmandade da Santa Casa de Misericordia de Sao Paulo; Hospital Samaritano Paulista; Instituto do Coração do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo; Hospital das Clinicas da Universidade Estadual de Campinas; Hospital de Base de Sao Jose do Rio Preto; Irmandade da Santa Casa de Misericórdia de Marília; Irmandade da Santa Casa de Misericórdia de Piracicaba; Hospital São Paulo da Universidade Federal de São Paulo; Hospital Pitangueiras do Grupo SOBAM; Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
• Investigators: Principal Investigator: Omar AV Mejia, MD,PhD, USP Heart Institute

Publications and helpful links

General Publications

• Orlandi BMM, Mejia OAV, Borgomoni GB, Goncharov M, Rocha KN, Bassolli L, Melo de Barros E Silva PG, Nakazone MA, Sousa A, Campagnucci VP, de Sousa Vilarinho KA, Katz M, Tiveron MG, Arrais Dos Santos M, Lisboa LAF, Dallan LAO, Jatene FB; REPLICCAR II Study Group. REPLICCAR II Study: Data quality audit in the Paulista Cardiovascular Surgery Registry. PLoS One. 2020 Jul 10;15(7):e0223343. doi: 10.1371/journal.pone.0223343. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2013
• Primary Completion (ACTUAL): September 1, 2016
• Study Completion (ACTUAL): August 1, 2019

Study Registration Dates

• First Submitted: May 2, 2022
• First Submitted That Met QC Criteria: May 2, 2022
• First Posted (ACTUAL): May 6, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Mortality; Quality improvement; Database; Coronary artery bypass grafting; Heart valve surgery
• Other Study ID Numbers: 450617006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The Comissão de Ética para Análise de Projetos de Pesquisa (CAPPesq) - HC-FMUSP https://www.hc.fm.usp.br/index.php?option=com_content&view=article&id=243:comissao-de-etica-para-analise-de-projetos-de-pesquisa-do-hcfmusp&catid=23&Itemid=229 ) approved this analysis as part of the Project: "Surgical Risk Stratification as an Instrument for Innovation in Cardiac Surgery Programs in the Unified Health System of the São Paulo State " (REPLICCAR 1) under online registration Nº.450617006. This retrospective analysis was performed without identifying the patients. Therefore, patients' informed consent form was waived.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No