Trang 1 School of Public Health Development of a clinical quality registry for percutaneous coronary intervention among coronary heart disease patients in Northern Vietnam: A pilot regis
School of Public Health Development of a clinical quality registry for percutaneous coronary intervention among coronary heart disease patients in Northern Vietnam: A pilot registry study Vu Thi Thanh Hoa This thesis is presented for the Degree of Doctor of Philosophy of Curtin University February, 2021 Author’s Declaration I declare that this thesis is my own account of my research and contains as its main content work which has not previously been submitted for a degree at any tertiary education institution To the best of my knowledge and belief this thesis contains no material previously published by any other person except where due acknowledgement has been made This thesis contains no material which has been accepted for the award of any other degree or diploma in any university The published papers have co-authors who have identified and acknowledged my contribution, included in Appendix The research presented and reported in this thesis was conducted in accordance with the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research (2007) – updated March 2014 The proposed research study received human research ethics approval from the Curtin University Human Research Ethics Committee (EC00262), Approval Number: HRE2017-0378 Candidate’s name: Vu Thi Thanh Hoa Signature: Date: 10 February 2021 ii Abstract Background Cardiovascular diseases remain the leading cause of death worldwide, and coronary heart disease is known as the most common underlying cause of cardiovascular diseases deaths and morbidity In Asia, the continent that is home to 60% of the world’s population, the burden of coronary heart disease has grown significantly in recent decades Considerable efforts have been put in place to manage the disease growth and improve quality of healthcare for patients Percutaneous coronary intervention has become the optimal choice for cardiac based treatments for coronary heart disease patients A variety of national and multicentre clinical quality registries have been established for monitoring, managing practice and improving outcomes for patients following percutaneous coronary intervention Despite the success of these percutaneous coronary intervention registries, there remains wide variation between nations and requires the data from real practice, especially in low resources settings countries This project describes the establishment of a pilot percutaneous coronary intervention registry in Vietnam and updates our understanding of percutaneous coronary intervention practices in Vietnam Objectives The aim of this study was to develop a pilot clinical quality registry in order to understand the practice of percutaneous coronary intervention, profiles of patients undergoing percutaneous coronary intervention, and outcomes of these patients at 30 days and 12 months The specific objectives were as follows: 1) to develop a framework/ model that could be utilised for a national registry in interventional cardiology in Vietnam; 2) to investigate the demographic and clinical characteristics iii of patients undergoing percutaneous coronary intervention in Northern Vietnam; 3) to examine the percutaneous coronary intervention outcomes at one and 12 months in Northern Vietnam; 4) to investigate the predictors of percutaneous coronary intervention outcomes at 12 months in Northern Vietnam; and 5) to estimate in- hospital costs associated with percutaneous coronary intervention per coronary patients in Vietnam Methods A hospital-based pilot registry study was conducted in the Vietnam National Heart Institute in Hanoi, Vietnam from September 2017 to May 2018 Participants were patients undergoing percutaneous coronary intervention during the study period Data collection tools were adapted from those used in a well-known percutaneous coronary intervention registry in Australia with relevant modifications and printed into paper- based forms Participants who agreed to participate in the study had data collected at baseline, and follow-ups at 30 days and 12 months At baseline, information of patients’ demographic, clinical history, presentations, treatments, percutaneous coronary intervention practices, blood tests, and in-hospital complications were collected via interviewing participants, reviewing medical records, and reading the secured disks in the catheterization laboratory At the two follow-ups points, information on complications, rehospitalization, and quality of life were obtained via face to face or phone interviews From the completed forms, data were coded and inputted twice into Epi-data, then transferred to SPSS for data analysis The data were summarised by means or percentages as appropriate Besides descriptive statistics and univariate analyses, multiple logistic and linear regressions were performed to iv investigate the association between independent factors with outcomes and hospital cost Results During the 9 months of data collection, 1,022 patients undergoing percutaneous coronary intervention were recruited from a total of 1,041 procedures conducted during that time frame The estimated mean time to collect information from patients before discharge was 60 minutes Of the collected data fields, 98% were successfully completed The estimated cost for data collection was 4.4 USD and 1.1-2.2 USD per patient at baseline and follow-up The viability of the first registry was confirmed by collecting the most representative sample size, high data quality, reasonable cost and time for data collection and strong support from patients, hospital staff and the leadership team at the institute where data were collected We identified patient profiles and investigated the clinical practices of percutaneous coronary intervention in Vietnam The mean age was 68.3 years, two thirds were male, 54.4% of patients presented with acute coronary syndromes and 14.5% of them were ST-elevation myocardial infarction The majority of lesions were classified as type B2 and C and the radial artery was the most common access location for percutaneous coronary intervention (79.2%) The use of drug-eluting stents was universal and the angiographic success rate was 99.4% Cardiac complications following PCI were rare with the exception of major bleeding (2.0%) Information of sex differences was also investigated, in which female patients were older with relatively more comorbidities and a higher incidence of major bleeding than males (p