1 HM 2211 – Special Study Module II Research Proposal CLINICAL SPECTRUM OF ENDOCARDITIS IN BRUNEI DARUSSALAM Nur Amani Syazwina bte Mohd Nor Amin 17b3086 PAPRSB Institute of Health Sciences Universiti Brunei Darussalam Supervisors

1 HM 2211 – Special Study Module II Research Proposal CLINICAL SPECTRUM OF ENDOCARDITIS IN BRUNEI DARUSSALAM Nur Amani Syazwina bte Mohd Nor Amin 17b3086 PAPRSB Institute of Health Sciences Universiti Brunei Darussalam Supervisors: Dr Hjh Fazean Irdayati binti Hj Idris PAPRSB Institute of Health Sciences Universiti Brunei Darussalam Dr Nazar Luqman Cardiology Consultant RIPAS Hospital

2 ABSTRACT Endocarditis is a disease involving the endocardium of the heart with a high mortality rate. Despite its incidence of five to six reported cases in Brunei Darussalam, there has not been any official published data regarding the disease locally. With this research looking at the clinical spectrum of endocarditis, the researcher aims to increase the knowledge and understanding of endocarditis in Brunei Darussalam by identifying risk factors, predisposing factors and any underlying heart disease commonly found in diagnosed endocarditis patients so preventive measures can be ruled out and public awareness of the disease can be raised. Researcher is also interested in the demographic profile of diagnosed patients as to better understand the incidence in Brunei Darussalam and data of clinical presentations that will be found in patients with endocarditis and the treatment plans that were given. This is to assist an early and better diagnosis so appropriate management and treatment plan can be given to future patients to provide better outcomes. The researcher will study the use of Duke Criteria to diagnose endocarditis to provide information on whether the patients fit into definite or possible endocarditis. This retrospective based cross sectional study will identify patients diagnosed with endocarditis in Brunei Darussalam from January 2015 to December 2017 through BruHims registry maintained by Department of Cardiology, RIPAS Hospital and the databases fom Gleneagles Jerudong Park Medical Centre (GJPMC). Extraction of data will be done by the clinical supervisor and authorized staff where the researcher will then be examining and collecting the data under supervision using a self-designed collection proforma and will take place once a week at a set day/time after the study has been ethically approved. Data will then be tabulated in in Microsoft Excel and analysed using R software or IBM SPSS Statistics 25 for Mac. Continuous variables will be recorded as mean +- SD and range while categorical variabes will be reported in percentages with 95% C.I and compares using Fisher’s exact test and Student’s t-test

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3 INTRODUCTION Endocarditis is a life-threatening disease that is defined as an infection of the endocardium of the heart which is the innermost tissue lining the heart chambers. Commonly infected heart structures are the heart valves. The infection is usually bacterial although fungal infection may also be the cause but unlikely. Underlying heart diseases such as rheumatic heart disease (RHD) and congenital heart defects are commonly associated with endocarditis. (1) Other risk factors include patients’ medical history that could suppress their immunity such as diabetes and AIDS, use of prosthetic heart valves and any intracardiac devices. Social behaviors of patients may also increase the risk of developing endocarditis such as excessive alcohol intake and intravenous self-administered illicit drugs. (2) The most common clinical features of endocarditis presenting in patients are fever higher than 38.0° C, heart murmurs and dyspnea. (3) Endocarditis is diagnosed using the modified Duke Criteria due to difficulty in ruling out the signs and symptoms and how atypical they usually present with. Modified Duke Criteria classify endocarditis as either definite or possible depending on the criteria the patients are presented with. (4) Staphylococcus aureus has been known to be the most frequent etiology of endocarditis especially in patients with artificial heart valves and intracardiac devices. (5) Endocarditis caused by this pathogen is known to have a poor prognosis compared to other microorganisms. (6) Global burden of endocarditis found in a systematic review has shown that the annual incidence of the disease has been estimated to be three to nine cases per 100000 persons in developed countries.(2) It has also been shown that two thirds of endocarditis cases occur in men. In developed countries, the age distribution of this disease is changing with cases endocarditis seen in young adults with a mean age of 30 years old, to cases seen in elderly with a mean age of 65 years old, where degenerative valvular disease is principally encountered. (7) Over the past few years, the epidemiology, clinical features and treatment of endocarditis has drastically changed. Studies have shown that it is due to a decrease in rheumatic heart disease (RHD) cases, an increase in congenital heart disease (CHD), an increase in people requiring intracardiac devices and prosthetic implants, more people abusing illicit drugs intravenously and cases of immunosupressants such as HIV patients and diabetic patients that contribute to high-risk groups. (8)

4 LITERATURE REVIEW This is a literature review of a study conducted retrospectively in 2016 in a tertiary care referral hospital located in East China. The study analysed hospital charts of patients diagnosed with definite or possible endocarditis that were admitted from January 2008 to December 2015 to the hospital. The population of the study was 174 patients presented with 135 definite and 39 possible endocarditis diagnosed using the modified Duke Criteria. The study had shown that 73.6% of patients diagnosed with endocarditis is known to have underlying heart disease which involve 30.5% degenerative valve disease, 29.9% congenital heart disease and 14.9% rheumatic heart disease. Intracardiac devices were also present in 93.7% of the diagnosed patients while 5.2% had prosthetic valves. (8) The study also analysed echocardiography results of the patients and had reported that 55.2% of patients were found to have large vegetation (;10mm) and most affected valve was the mitral valve in 58.6% of patients. Valve regurgitation was also observed in 58.0% of patients. (8) The main causative agent of endocarditis found in this study was Streptococci in 61.9% of patients while Staphylococci was found in 25.6% of patients. All patients were treated with antimicrobial therapy and 43.7% of patients were followed up with surgical treatment which include valve replacement, valvuloplasty, pacemaker lead extraction and CHD repair. Complications during hospital stay found in the study include 20.1% neurological events such as stroke, hemorrhage, 14.9% cases of systemic embolism and 69.0% of patients experienced congestive heart failure. The mortality rate during hospital stay was 10.9%.

5 AIMS ; RATIONALE OF RESEARCH: At present, there has not been any published data regarding endocarditis in Brunei Darussalam despite its occurrence and high morbidity and mortality. Five to six cases of endocarditis are reported annually in Brunei Darussalam but there has been no official published data regarding the disease locally. It is in the researcher’s interest that this research will increase the knowledge and understanding of endocarditis in Brunei Darussalam by identifying risk factors, predisposing factors and any underlying heart disease commonly found in diagnosed endocarditis patients so preventive measures can be ruled out and public awareness of the disease can be raised. Secondly, researcher is interested in the demographic profile of diagnosed patients as to better understand the incidence in Brunei Darussalam. Next, data of clinical presentations that will be found in patients with endocarditis can help in an early and better diagnosis so appropriate management and treatment plan can be given to future patients to provide better outcomes. Furthermore, evaluating the treatment plan alongside the diagnosed patients’ outcomes may provide an idea on which treatment works best for specific patients. Finally, studying the Duke Criteria to diagnose endocarditis in Brunei Darussalam will provide information on which criteria most patients present with and whether they fit into definite or possible endocarditis. OBJECTIVES OF STUDY: The objectives of this study are to: 1. Identify the demographic profile (age, gender and ethnicity); diagnosis of possible or definite endocarditis through the use of Duke Criteria; blood cultures (positive/negative, bacterial/fungal, organisms); echocardiography results (site, size, number of vegetations, abscess, new valvular regurgitation, dysfunction of prosthetic valve) and management of patients with endocarditis 2. Determine whether endocarditis is associated with risk factors such artificial heart valves, intracardiac devices, congenital heart defects, degenerative valvular lesions, medical history that could suppress immunity (diabetes, use of alcohol, illegal drug use, HIV/AIDS, recent invasive procedure such as dental treatment)) 3. Determine whether endocarditis is associated with underlying heart disease (defective/diseased heart leading to bacteremia, rheumatic heart disease)

6 4. Investigate the outcome of patients after being treated for endocarditis 6 months-1 year of being diagnosed METHODS: (Study design, Population, Data collection method, Research instruments, Data analysis, Ethical considerations) Study design: This study is a retrospective based cross sectional study. Population: Patients diagnosed with endocarditis in Brunei Darussalam will be identified from January January 2015 to December 2017 through BruHims registry maintained by Department of Cardiology, RIPAS Hospital and the databases fom Gleneagles Jerudong Park Medical Centre (GJPMC). Selection criteria will be all patients diagnosed with endocarditis using Duke Criteria and those with missing or incomplete records will be excluded. Data collection method: Data will be extracted from BruHims, RIPAS Hospital and GJPMC database by the clinical supervisor and authorized staff where the researcher will then be examining and collecting the data under supervision. Any personal data of patients such as BruHims number, name, identification card number will not be given to the researcher and will be censored by the nurse officers. Researcher will give the patients a code so to identify the cases and to ensure no replication of data. Data collection will take place once a week at a set day/time once ethical approval is sought for a period of 3-4 months, depending on the mutual availability of the clinical supervisor and researcher. Research instruments: A self-designed data collection proforma will be used to collect the following data for the purpose of the study. A sample proforma is attached in Appendix 1: 1) Patient’s demographic profile (age, gender, ethnicity) 2) Patient’s medical history (diabetic/HIV/recent invasive procedure/heart diseases/use of prosthetic heart valves/intracardiac devices), social history (alcohol intake/illicit drug use)

7 3) Diagnosis of patients whether it was possible or definite endocarditis based on the Duke Criteria 4) Blood cultures (positive/negative, bacterial/fungal, organisms) 5) Echocardiography results (site, size, number of vegetations, abscess, new valvular regurgitation, dysfunction of prosthetic valve) 6) Treatment plan (medication, surgery, duration of treatment) 7) Six months to 1 year follow up to see patients’ outcome after being treated for endocarditis Data analysis: The data collected will be tabulated in Microsoft Excel and analysed using R software or IBM SPSS Statistics 25 for Mac. Continuous variables (i.e age) will be recorded as mean +- SD and range while categorical variables (i.e gender, ethnicity, risk factors, diagnostic criteria, outcomes of patients) will be reported in percentages will be used with 95% confidence intervals and compared using Fisher’s exact test for categorical variables while Student’s t-test will be used to compare quantitative variables with standard level of significance, p12 hours apart or 3-4 separate blood cultures where first and last sample drawn 1 hour apart Echocardiographic evidence of endocardial involvement: vegetations, abscess, new valvular regurgitation, dysfunction of prosthetic valve Minor criteria: Predisposing heart condition or intravenous drug use Temperature >38.0° C Vascular phenomena: major arterial emboli, septic pulmonary infarcts, mycotic aneurysm, intracranial hemorrhage, conjunctival hemorrhages, Janeway’s lesions Immunologic phenomena: glomerulonephritis, Osler nodes, Roth spots, rheumatoid factor Microbiological evidence: positive blood culture but does not meet a major criterion as above or serological evidence of active infection with organisms consistent with endocarditis Definite (2 major/ 1 major + 3 minor/ 5 minor) Possible (1 major + 1 minor/ 3 minor)

12 PATIENT’S CLINICAL PRESENTATION Clinical manifestations: Fever > 38.0° C Heart murmur Petechiae Splinter hemorrhages Osler nodes Janeway lesions Roth spots Nail clubbing Weight loss Anemia Splenomegaly Dyspnea Vomiting Abdnominal pain Seizures Embolic events Echocardiogram result: Vegetation Location: Mitral valve Aortic valve Mitral and aortic valve Tricuspid valve Pulmonary valve Other sites Size: 10mm Number: Single Multiple New/worsening regurgitation Dehiscence of prosthetic valve Cardiac abscess Blood culture: Positive Negative Microorganism: Viridans-group streptococci Streptococcus bovis HACEK group Staphylcoccus aureus Enterococci Fungal

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