Graduate thesis of General medicine: Local vascular complications after coronary angiography and or percutaneous coronary intervention and related factors at coronary care unit of Vietnam national heart institute, Bach Mai hospital

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This study "Local vascular complications after coronary angiography and/or percutaneous coronary intervention and related factors at coronary care unit of Vietnam national heart institute, Bach Mai hospital" for the following two purposes: Evaluate the proportion of local vascular complications (LVC) after coronary angiography and/or coronary intervention at the Coronary Care Unit, Vietnam Heart Institute in 2022; investigate some factors related to complications of puncture wounds in patients with coronary angiography and/or intervention at the Coronary Care Unit.

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Nội dung Text: Graduate thesis of General medicine: Local vascular complications after coronary angiography and or percutaneous coronary intervention and related factors at coronary care unit of Vietnam national heart institute, Bach Mai hospital

VIETNAM NATIONAL UNIVERSITY SCHOOL OF MEDICINE AND PHARMACY ANH THI NGOC VU LOCAL VASCULAR COMPLICATIONS AFTER CORONARY ANGIOGRAPHY AND/OR PERCUTANEOUS CORONARY INTERVENTION AND RELATED FACTORS AT CORONARY CARE UNIT OF VIETNAM NATIONAL HEART INSTITUTE GRADUATE THESIS OF GENERAL MEDICINE Hanoi– 2023 1
VIETNAM NATIONAL UNIVERSITY SCHOOL OF MEDICINE AND PHARMACY Thesis maker: ANH THI NGOC VU LOCAL VASCULAR COMPLICATIONS AFTER CORONARY ANGIOGRAPHY AND/OR PERCUTANEOUS CORONARY INTERVENTION AND RELATED FACTORS AT CORONARY CARE UNIT OF VIETNAM NATIONAL HEART INSTITUTE GRADUATE THESIS OF GENERAL MEDICINE Class year: QH.2017Y Suppervisor 1: M.Sc. Dr. HIEU BA TRAN Suppervisor 2: M.Sc. Dr. NHUNG THI HUYNH Hanoi– 2023 2
ACKNOWLEDGMENT On the occasion of completing my graduation thesis, with deep respect and gratitude, I would like to express my gratitude to: The Board of Directors, Department of Internal Medicine, University of Medicine and Pharmacy - Hanoi National University have created favorable conditions for me during my study and research. I would like to express my sincerest thanks to my Ph.D. Hoai Thi Thu Nguyen, head of the Internal Affairs Department, University of Medicine and Pharmacy - VNU, Deputy Director of the Institute of Cardiology opened up the opportunity for me to participate in research and complete this thesis. In particular, I would like to express my deep respect and gratitude to M.Sc. Hieu Ba Tran, doctor of C7 - Coronary Care Unit - Vietnam Heart Institute and teacher of Internal Affairs Department, VNU. You are the one who wholeheartedly guided and created all conditions for me in the process of studying and researching. I am also deeply thankful to M.Sc. Nhung Thi Huynh, Internal Academic Affair, Department of Internal Medicine - University of Medicine and Pharmacy - VNU has wholeheartedly supported me and enthusiastically facilitate to help me complete this thesis. Thank you sincerely: Doctors, nurses, and staff of Vietnam Heart Institute, Bachmai Hospital. I also thank my family who encouraged me and prayed for me throughout the time of my research. Hanoi, day month 2023 Thesis maker Anh Thi Ngoc Vu 3
GUARANTEE I hereby declare that all the data in this thesis is my own and has not been used or published in any other document. If something goes wrong, I take full responsibility. Hanoi, day month 2023 Thesis maker Anh Thi Ngoc Vu 4
TABLE OF CONTENTS ACKNOWLEDGMENT ........................................................................................... 3 LIST OF ACRONYMS............................................................................................. 9 INTRODUCTION ..................................................................................................... 0 CHAPTER 1: LITERATURE REVIEW .................................................................. 1 1.1. Coronary artery disease ..................................................................................... 1 1.2. Percutaneous coronary artery imaging and intervention (PCI) ......................... 3 1.2.1. Intravascular access in coronary angiography and intervention .................. 3 1.2.2. Hemostasis after removal of sheaths and other types of compression and vascular closure devices ......................................................................................... 6 1.2.3. Local Vascular Complications ..................................................................... 9 1.3. Research on local vascular complications after intervention and/or angiograpgy in Vietnam and worldwide ...................................................................................... 12 1.3.1. Studies in the world .................................................................................... 12 1.3.2. Studies in Vietnam ..................................................................................... 12 CHAPTER II: SUBJECTS AND METHODS........................................................ 15 2.1. Subjects ............................................................................................................ 15 2.1.1. Object ......................................................................................................... 15 2.1.2. Time, place ................................................................................................. 15 2.1.3. Selection Criteria ........................................................................................ 15 5
2.1.4. Exclusion criteria ....................................................................................... 15 2.1.5. The criteria used in the study ..................................................................... 16 2.2. Research Methods ............................................................................................ 25 2.2.1. Research design .......................................................................................... 25 2.2.2. Sample size ................................................................................................. 25 2.2.3. Research process ........................................................................................ 25 2.3. Main research variable ..................................................................................... 27 2.3.1. Characteristics of the research object......................................................... 27 2.3.2. Procedure variables: ................................................................................... 27 2.3.3. Variables for follow-up in the ward ........................................................... 27 2.4. Analyzing data.................................................................................................. 28 2.5. Research media ................................................................................................ 28 2.6. Research Ethics ................................................................................................ 29 CHAPTER 3: RESULTS ........................................................................................ 30 3.1. General characteristics of the study population ............................................... 30 3.1.1. Distribution of age and gender ................................................................... 30 3.1.2. Distribution characteristics of coronary artery disease .............................. 31 3.1.3. Characteristics of the comorbidities ........................................................... 31 3.1.4. Characteristics of clinical indicators of the study group............................ 32 3.1.5. Features of coronary angiography and intervention: ................................. 34 3.1.6. Features of the use of anticoagulants and antiplatelet agents .................... 35 6
3.1.7. Use of unfractionated heparin in the procedure ......................................... 36 3.1.8. Rate of radial and femoral artery intervention ........................................... 36 3.1.9. Sheath size ratio ......................................................................................... 37 3.1.10. Procedure time and sheath withdrawal time ............................................ 37 3.2. Complications of vascular puncture wound complications ............................. 37 3.2.1. Rate of some complications of puncture wound ........................................ 37 3.2.2. Percentage of hematoma by size ................................................................ 38 3.3. Factors associated with vascular complications: ............................................. 38 3.3.1. The relationship of complications with age ............................................... 38 3.3.2. Complications relationship with gender .................................................... 39 3.3.3. The relationship of complications with the comorbidities......................... 40 3.3.4. The relationship between some clinical indicators with hematoma complications: ...................................................................................................... 43 3.3.5. The relationship of complications with drug use ....................................... 44 3.3.6. Comparison of mean values of some paraclinical indicators in the group with complications and without complications .................................................... 45 3.3.7. Relationship of complications with the performing artery ........................ 46 3.3.8. Relationship of complications with the procedure performed: .................. 47 3.3.9. Comparison of mean procedure time in the hematoma group and no hematoma ............................................................................................................. 47 CHAPTER 4: DISCUSSION .................................................................................. 48 4.1.1. Characteristics of age and sex .................................................................... 48 7
4.1.2. Features of cardiovascular disease ............................................................. 48 4.1.3. Characteristics of comorbidities................................................................. 49 4.1.4. Clinical features.......................................................................................... 49 4.1.5. Paraclinical features ................................................................................... 50 4.1.6. Features of using anticoagulants and antiplatelet drugs ............................ 50 4.1.7. Features of the intervention process........................................................... 51 4.2. Factors related to local vascular complications ............................................... 52 4.2.1. Complication rate ....................................................................................... 52 4.2.2. The relationship between clinical parameters and complications of hematoma ............................................................................................................. 52 4.2.3. The relationship between paraclinical parameters and complications of hematoma ............................................................................................................. 54 4.2.4. Relationship between complications and access: ...................................... 54 4.2.5. Relationship of complications with the procedure performed: .................. 55 4.2.6. Relationship of complications with antiplatelet therapy used: .................. 55 4.2.7. The relationship between the parameters of the procedure and after the procedure with local bleeding complications: ..................................................... 55 CONCLUSION ....................................................................................................... 57 REFERRENCE ......................................................................................................... 0 8
LIST OF ACRONYMS WHO World Health Organization CT Computer Tomography MSCT Multislice Computer Tomography MRI Magnetic Resonance Imaging ACS Acute coronary syndrome CCS Chronic coronary syndrome STEMI ST Elevation Myocardial Infarction ESC European Society of Cardiology BMI Body Mass Index BP Blood pressure SBP Systolic blood pressure DBP Diastolic blood pressure PCI Percutaneous Coronary Intervention Non – STEMI Non -ST Elevation Myocardial Infarction UA Unstable angina DAPT Dual antiplatelet therapy MI Myocardial Infraction 9
LIST OF TABLES Table 1. 1. Comparison of femoral and radial arteries in percutaneous coronary angiography and intervention ................................................................................... 4 Table 2. 1. Classification of angina CCS ................................................................ 17 Table 3. 1. Age distribution by age group............................................................... 30 Table 3. 3. Distribution of coronary artery disease ................................................. 31 Table 3. 4. Comorbidity characteristics .................................................................. 31 Table 3. 5. Blood pressure characteristics............................................................... 32 Table 3. 6. Prevalence of hypertension by age group ............................................. 32 Table 3. 7. BMI characteristics by gender .............................................................. 33 Table 3. 8. BMI characteristics by age group ......................................................... 33 Table 3. 9. Characteristics of some subclinical test of research subjects ............... 34 Table 3. 10. Characteristics of coronary angiography and coronary intervention.. 34 Table 3. 11. Prevalence of use of anticoagulants, anticoagulants ........................... 35 Table 3. 12. Doses of unfractionated heparin used in the procedure ...................... 36 Table 3. 13. Characteristics of the vascular access routes ...................................... 36 Table 3. 14. Characteristics of using a sheath ......................................................... 37 Table 3. 15. Procedure time .................................................................................... 37 Table 3. 16. Rate of some complications at the puncture site................................. 38 Table 3. 17. Proportion of hematomas by size ........................................................ 38 Table 3. 18. Distribution of complications by age group ....................................... 39 Table 3. 19. Distribution of complications by gender............................................. 39 10
Table 3. 20. Distribution of complications by comorbidities ................................. 40 Table 3. 21. Relationship between complications and having two or more comorbidities ........................................................................................................... 41 Table 3. 22. Distribution of complications according to hypertension ................... 41 Table 3. 23. Distribution of complications by diabetes .......................................... 42 Table 3. 24. Hematoma characteristics according to dyslipidemia ........................ 42 Table 3. 25. Average comparison of some clinical indicators between the two groups with and without complications .................................................................. 43 Table 3. 26. Comparison of rates of use of anticoagulants and ARBs between the two groups with and without complications ........................................................... 44 Table 3. 27. Complication rates between different DAPT groups .......................... 44 Table 3. 28. Comparison of mean values of some paraclinical indicators in the group with complications and without complications ............................................ 45 Table 3. 29. Complications by access artery ........................................................... 46 Table 3. 30. Complications with the procedure performed .................................... 47 Table 3. 31. Comparison of mean procedure time in the hematoma group and no hematoma ................................................................................................................ 47 11
LIST OF FIGURES Figure 1. 1. Diagnosis of acute coronary syndromes ................................................ 1 Figure 1. 2. Approach to acute coronary syndromes ................................................ 2 Figure 1. 3. Compression of the radial artery (Terumo Medical Corp.) ................... 7 Figure 1. 4. Radial artery compression bandage at the Vietnam National Heart Institute [19] .............................................................................................................. 7 Figure 1. 5. Angio Seal (St. Jude Medical, St. Paul, MN) ........................................ 8 Figure 2. 1. Diagram of 6 steps to diagnose coronary artery disease (ESC 2019) . 19 Figure 2. 2. Strategies for treatment in ACS without ST-segment elevation and for patient referral ......................................................................................................... 22 Figure 2. 3. Flowchart of the research process ....................................................... 29 LIST OF CHART Chart 3. 1. Gender distribution ................................................................................ 30 12
INTRODUCTION According to WHO 2022, coronary artery disease (CAD) is the leading cause of mortality and illness burden in developing countries. Every year, in the United States, more than 700,000 people are hospitalized due to myocardial infarction (MI), and 50% of patients with acute MI die before reaching the hospital. Despite the considerable breakthroughs in detection and treatment over the past few decades, coronary heart disease, especially MI, still remains a public health problem in developed countries and is becoming increasingly important in the developing world. Vietnam is one of these developing nations [1]. Percutaneous coronary imaging and intervention (PCI) is the gold standard in the diagnosis and treatment of atherosclerotic coronary artery disease. PCI can have many complications during the procedure such as death, MI, contrast-induced nephropathy, and bleeding in the arterial access [2]. Currently, the femoral artery and the radial artery are the two common vascular approaches in the recommendations for diagnosing and treating coronary artery disease. In particular, complications at the puncture site are the most common clinical complications and increase mortality and periprocedural events. Therefore, limiting these incidents during and after the intervention plays a crucial role. Many studies have been done to detect factors that increase the risk of complications. The study of Yohei Numasawa recorded the rate of bleeding complications at the puncture site as 26.5% in which age, gender and BMI, sheath size, the diameter of the artery being vascularized, time of compression, and antiretroviral drugs are the relevant factors [4]. Vaso-occlusive complications have been reported with rates ranging from 0.8% to 38%. In Vietnam, according to research by author Thu T.H.N, the complication rate of the procedure is hematoma (11.5%), bleeding (8.2%), embolism (6.6%), pseudoaneurysm (3.3%), and closely related to arterial access [5]. Another study by Binh T.Q. on 252 patients showed that local vascular complications (LVC) of the femoral artery procedure group: bleeding 0%, large hematoma (>10cm) was 1.17%, small hematoma 5-10 cm 2.24%, 0.12% pseudoaneurysm, artery occlusion in 0.12% of patients. LVC of the radial procedure 0
group: 0% bleeding, small hematoma 5-10 cm 1.58%, 0% pseudoaneurysm, 0% obstruction. The risk factors for the femoral artery were age, gender, and blood pressure, while for the radial artery, it was only blood pressure [6]. In the literature, there have been many studies referring to complications of vascular access in the world as well as in Vietnam in particular. However, during the course of the Covid-19 epidemic with many differences in entering blood vessel devices as well as depending on the experience of the surgeon because the Vietnam National Heart Institute is a training unit in cardiovascular intervention with numerous students. Therefore, we perform this study “LOCAL VASCULAR COMPLICATIONS AFTER CORONARY ANGIOGRAPHY AND/OR PERCUTANEOUS CORONARY INTERVENTION AND RELATED FACTORS AT CORONARY CARE UNIT OF VIETNAM NATIONAL HEART INSTITUTE, BACH MAI HOSPITAL.”, for the following two purposes: 1. Evaluate the proportion of local vascular complications (LVC) after coronary angiography and/or coronary intervention at the Coronary Care Unit, Vietnam Heart Institute in 2022. 2. Investigate some factors related to complications of puncture wounds in patients with coronary angiography and/or intervention at the Coronary Care Unit, Vietnam Heart Institute in 2022. 1
CHAPTER 1: LITERATURE REVIEW 1.1. Coronary artery disease Coronary artery disease (CAD) is the leading health burden in developing and developed countries; is responsible for one-third of all deaths in adults over the age of 35 worldwide. In Vietnam, coronary artery disease has also become one of the headmost causes of mortality. In 2016, according to a report by WHO, it was estimated that 31% of deaths in Vietnam were due to cardio disease, of which more than half were due to coronary artery disease. Atherosclerotic coronary artery disease includes two clinical syndromes: Figure 1. 1. Diagnosis of acute coronary syndromes [53] Chronic coronary syndrome is a new term introduced at the European Society of Cardiology (ESC) 2019, instead of stable angina pectoris, stable CAD, chronic ischemic cardiomyopathy, or coronary insufficiency. Acute coronary syndromes (ACS) include ST-elevation myocardial infarction (STEMI), non-ST-elevation myocardial infarction (NSTEMI), unstable angina (UA) (Figure 1.1) 1
Approach to acute coronary syndromes (Figure 1.2) Figure 1. 2. Approach to acute coronary syndromes [53] 2
1.2. Percutaneous coronary artery imaging and intervention (PCI) Percutaneous coronary angiography and intervention are the gold standards in the diagnosis and treatment of coronary artery disease. 1.2.1. Intravascular access in coronary angiography and intervention 1.2.2.1. Importance of vascular access One of the most essential steps in percutaneous coronary angiography and intervention is the vascular access selection. Selectable entry sites are the femoral artery, brachial artery, or radial artery. However, regardless of artery location, the instrument, technique, and experience of the surgeons play an essential role in ensuring the success of the procedure and minimizing the risk of associated complications. Complications related to the puncture site not only affect the effectiveness of the intervention but can also alter patient outcomes. A study by Mamas et al in 2013 of 46,128 patients undergoing coronary angiography and intervention showed that radial bypass was an independent factor in reducing 30-day mortality (HR 0.71 CI 95) %: 0.52 - 0.97 with p
1.2.2.2. The femoral and radial arteries The first coronary interventions used the femoral artery to access and since then, the femoral artery has been chosen as the access routes for coronary intervention due to many advantages such as easy access, and manual procedure, simple technique, large femoral artery size, easy use of a sheath, guiding catheter, less spasm… In the United States, interventionists still commonly use access from the femoral artery, however, the rate of interventions through the radial artery is increasing day by day. In some intervention rooms in the United States and in Europe, the rate of radial artery intervention exceeds 90%. Table 1. 1. Comparison of femoral and radial arteries in percutaneous coronary angiography and intervention [19] Criteria Femoral arteries Radial arteries Bleeding 3 - 4% 0 – 0.6% 2- 3% Pseudoaneurysm, Vascular Rare, loss of rotator cuff arteriovenous complications (6 - 9%) catheterization Comfort level Acceptable Comfortable Motionless At least 4 hours Comfortable movement Expensive Cheap Expense (if using a circuit breaker) (pressure tape) Time Shorter Not significantly longer irradiation time Shorter Not significantly longer Access to the left Difficult, mainly through internal mammary Easy the right internal artery mammary artery Use a large catheter Easy Under 7F Obesity, lower extremity vascular Hard Unaffected disease 4
In 1989, Campeau first performed diagnostic coronary angiography through the radial artery, then in 1993 Kemeneij and Laarman successfully performed the first coronary intervention through the rotator, opening a new era for imaging and intervention. The radial access leaves very few complications related to the puncture site, although the approach is more difficult in terms of technique and requires the higher skill of the surgeons. A comparison of the advantages and disadvantages of these two interventional vascular sites is summarized in Table 1.1. Many studies have been conducted and have shown the advantages of using the radial artery over the femoral artery. Two randomized controlled trials favor radial versus femoral interventions in patients with STEMI undergoing coronary intervention. In the RIFLE STEACS study (Radial Versus Femoral Randomized Investigation in ST Elevation Acute Coronary Syndrome study), a multicenter randomized trial of 1001 patients with STEMI, radial access route was associated with a significantly lower cardiovascular mortality (5.2% vs 9.2%) and bleeding (7.8% vs 12.2%) compared with femoral artery [20]. The RIVAL trial (Radial Versus Femoral Access for Coronary Intervention) compared the efficacy and bleeding events between radial and femoral interventions in patients with ST-elevation or NSTEMI. Radial artery intervention was associated with a reduction in all-cause mortality (1.3% vs 3.2%) and a reduction in death/MI/stroke (2.7% vs 4.6%) in patients with STEMI but not in NSTEMI. In both groups, the radial intervention significantly reduced major bleeding and complications at the site of angiography [21]. The 2017 European Society of Cardiology (ESC) guideline for patients with STEMI recommends radial intervention over femoral artery intervention if performed by surgical procedures experienced staff (IIa, level of evidence b) [22]. The American Society of Angiography and Cardiovascular Intervention also provides consensus on best practices for using the radial artery in the diagnosis and treatment of coronary artery disease, with a focus on avoiding radial artery occlusion 5
and reducing exposure STEMI [23]. There is still much controversy surrounding which road approach is optimal. Opinions in favor of femoral artery intervention are based on (1) Fast (2) Bleeding complications have been greatly reduced thanks to vascular closure devices (3) Easy to change the intervention catheter size, easy ease of use of assistive devices such as aortic balloon counterpulsation (4) The radial artery if used for intervention, is not suitable for later use as a bridge in coronary artery bypass surgery (5) Intervention through the radial artery is difficult if there are cases of the small radial pulse, constriction, torsion, brachial artery and subclavian artery twisting and flexing [27]. For surgeons and technicians in the intervention room today, access through both the radial and femoral arteries is relatively easy. Therefore, in coronary angiography and percutaneous coronary intervention, "radial artery first, then femoral artery" should be performed whenever possible, except in special cases. 1.2.2. Hemostasis after removal of sheaths and other types of compression and vascular closure devices 1.2.2.1. Radial artery There are many types of devices designed to stop bleeding at the radial puncture site, such as the Radistop (St Jude Medical, St. Paul, MN) or the TR ring (Terumo Medical Corp, Somesert, NJ) (see figure 1.3). The principle when using these types of instruments is that the device will be placed at the puncture site so that the puncture site is covered. While the sheath is being pulled out slowly, the cuff is gradually inflated. By the time the sheath is completely withdrawn, the bandage should be sufficiently taut so that no bleeding can be seen at the puncture site. At the Vietnam National Heart Institute and many intervention rooms in Vietnam, the method of radial compression with gauze and tape is routinely used because of its effectiveness, speed, and very low cost. With the advantage of radial artery size, smaller, lying on the hard bone, withdrawing and hemostasis of the puncture site at the radial artery becomes easier. The surgeon or technician, the nurse 6