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MINISTRY OF EDUCATION AND TRAINING MINISTRY OF HEATH HANOI MEDICAL UNIVERSITY ====== LE XUAN THAN EARLY AND MID-TERM OUTCOMES FOLLOWING TEVAR FOR ACUTE COMPLICATED STANFORD B AORTIC DISSECTION Specialism : Cardiovascular Code : 9720107 ABSTRACT OF THESIS HA NOI - 2022 The thesis has been completed at HANOI MEDICAL UNIVERSITY Supervisors: Supervisor 1: Assoc.Prof.PhD: Pham Manh Hung Supervisor 2: Assoc.Prof.PhD: Nguyen Ngoc Quang Reviewer 1: Reviewer 2: Reviewer 3: The thesis will be present in front of board of university examiner and reviewer lever at… on ….2022 This thesis can be found at: National Library: - National Medical Informatics Library - Library of Hanoi Medical University INTRODUCTION Acute aortic dissection (AAD) have been increasing Reported incidences of aortic dissection range from to cases per 100,000/year AAD is a life-threatening condition associated with high morbidity and mortality Overall in-hospital type B mortality was 13,3% Medical management remained the standard of care for patients with uncomplicated acute Type B Aortic Dissection (TBAD) Open surgical repair of complicated acute TBAD have the morbidity and mortality remain prohibitively high Around the world, Thoracic Endovascular Aortic Repair (TEVAR) is now acknowledged as a less invasive treatment and useful therapy for acute complicated TBAD There was some research about TEVAR for the treatment of aortic diseases in Vietnam However, no more clinical trials that gather more information about safety and effectiveness of TEVAR to treat acute complicated TBAD We have done this study at Vietnam National Heart Insitute - Bach Mai Hospital for purposes of: Evaluation of early and mid-term result of TEVAR to treat acute complicated TBAD Identify risk factors that influence the outcomes of TEVAR for acute complicated TBAD Chapter 1: OVERVIEW 1.1 Overview of TBAD 1.1.1 Anatomy and histology of the aorta - The aorta can be divided into four sections: the ascending aorta, the aortic arch, the thoracic descending aorta and the abdominal aorta - Aortic wall consists of three layers: outer adventitia, middle media, inner intima 1.1.2 Epidemiology, Pathophysiology of TBAD Incidences of acute TBAD range from 2,9 to cases per 100,000/year Tear in the intimal layer of the descending thoracic aorta, with consequent blood flow within the medial layer of aorta Coplications of the TBAD include rupture or the thoracic aorta, malperfusion 1.3 Clinical presentation, diagnosis acute aortic dissection Table 1: Clinical data useful to assess the a priori probability of acute AD High-risk conditions - Marfan syndrome (or other connective tissue diseases) - Family history of aortic High-risk pain features Chest, back, or abdominal pain described as any High-risk examination features - Evidence of perfusion deficit: Pulse deficit disease - Known aortic valve disease - Known thoracic aortic aneurysm Previous aortic manipulation (including cardiac surgery) or the following: abrupt onset severe intensity Ripping or tearing ● Systolic blood presure difference ● Focal neurological deficit (in conjunction with pain) - Hypotension or shock Figure Flowchart for decision-making based on pre-test sensitivity of acute aortic syndrome (ESC 2014) 1.1.4 Classification of aortic dissection - Classified according to the timing of symptom Acute aortic dissection (AD) (< 14 days from onset), Sub-acute AD ( 14 90 days) and chronic AD (> 90 days) - Classified according to anatomy Stanford classification of aortic dissection: Type A involves the ascending aorta and may progress to involve the arch and thoracoabdominal aorta Type B involves the descending thoracic or thoracoabdominal aorta distal to the left subclavian artery without involvement of ascending aorta 1.1.5 Management of Acute, Complicated Type B Aortic Dissection 1.1.5.1 Medical therapy - Control pain - Control heart rate: < 60 b/m - Control blood pressure: 100 – 120 mmHg 1.1.5.2 Surgery Indication: acute complicated TBAD The aim of open surgical repair is to replace the descending aorta with a Dacron prosthesis Disadvantage: Open surgical repair for acute complication TBAD is complex and has a high risk of morbidity and mortality 1.1.5.3 Aortic fenestration Indication: Open fenestration for treating ischemic complications of acute TBAD Aortic fenestration is a method for decompressing the hypertensive false lumen by creating a hole in the distal part of the dissection flap Advantage and disadvantage: Surgical aortic fenestration is less invasive than total aortic replacement However, this technique cannot prevent aortic dilatation in the entire dissected aorta during follow-up 1.2 TEVAR for acute complicated TBAD 1.2.1 Principle TEVAR therapy in TBAD The concept of endovascular treatment of TBAD are to cover the entry tear, treat or prevent impending rupture, reestablish organ perfusion, revascular in the true lumen, and induce the false lumen thrombosis Figure 1.2 Concept of TEVAR treat type B aortic dissection 1.3 Domestic and international research 1.3.1.Intenational research about TEVAR for acute complicated TBAD Qin et all examined 152 patients with acute complicated TBAD treated with TEVAR Procedural success rate was 94,7%, overall inhospital mortality rate was 2%, stroke rate was 1,3% and paraplegia rate was 1,3%, type I endoleak was 2,6% and retrograde type A aortic dissection was 1,3% Fattori et all the investigators of the International Registry of Acute Aortic Dissection (IRAD) with 290 patients reported that in-hospital mortality rate was 10,9%, stroke rate was 2,3% and paraplegia rate 1,3% After years follow up, re-intervention rate was 30,6% and Endoleak rate was 13,4%, mortality rate was 15,5% There is no randomized control trial evaluating outcomes for TEVAR versus surgery for acute complicated TBAD However, TEVAR is known to have lower peri-operative morbidity and mortality compared to open repair 1.3.2.Research about TEVAR for acute complicated TBAD in Vietnam Nguyen Lan Hieu, Tran Vu Hoang “Evaluating efficacy of aortic Stent graft treatment in patients with aortic disease in Vietnam Heart Institute” Tran Quyet Tien, Phan Duy Kien “ Results of emergency intervention with Stent graft for aortic disease at Vascular Surgery Department, Cho Ray Hospital” Nguyen Hoang Đinh, Nguyen Thoi Hai Nguyen “ Endovascular repair for the treatment of aortic disease: experience at the Department of Cardiovascular Surgery, HCMC University of Medicine and Pharmacy” so, these Studies show the feasibility and effectiveness of TEVAR for orther aortic disease, However, there was no trial specially evaluating the results of TEVAR to treat acute complicated TBAD 1.3.3 The Issues to be investigated in TEVAR for acute complicated TBAD Results of TEVAR for acute complicated TBAD and risk factors affecting the outcome in Vietnam? How to optimize the outcome of TEVAR in the treatment of acute complicated TBAD? Chapter MATERIALS AND METHODS 2.1 Materials The patients were diagnosed with acute complicated TBAD and assigned endovascular intervention 2.1.1 Inclusion criteria Acute Stanford type B aortic dissection associated with complications: Rupture: hemothorax, mediastinal hematoma, peri-aortic hematoma Malperfusion syndrome: ischemia of organs such as kidneys, small intestine, spinal cord, lower extremities Refractory pain Uncontrolled systemic hypertension 2.1.2 Exclusion criteria Aortic anatomy is not suitable for endovascular intervention such as the diameter of the proximal landing zone is too large (> 42mm), the patient has an ascending aortic aneurysm, the aortic arch diameter greater than 46 mm, the Stanford B aortic dissection but has aotic intramural hematoma spread to the aortic arch or ascending aorta Access to the femoral artery cannot perform interventions such as a heavy calcification, tortuous, severe stenosis or occlusion of the iliac artery Patients with genetic aortic disease (eg, Marfan syndrome) Patients have anaphylaxis with contrast Patients with serious medical diseases such as cirrhosis, end-stage cancer 2.2 Methods 2.2.1 Study location and time The study was conducted at the Heart Institute - Bach Mai Hospital, from January 1, 2014, to June 30, 2021 2.2.2 Study design Uncontrolled clinical trial 2.2.3 Sample size and sampling Mortality rate after intervention for the treatment of acute Stanford B aortic dissection in the in-hospital period of large studies resulted in a 92.7% survival rate We use the formula to calculate the minimum study sample size according to the formula: n = 102 patients 2.2.4 Study protocol 2.2.4.1 Patient selection: based on inclusion and exclusion criteria 2.2.4.2 Evaluate before the procedure: - Take for medical history - Clinical and subclinical examination - Computed tomography of the aorta and measured dimensions at anatomical landmarks according to the guidelines of the European Society of Cardiology Figure 2.1 The method for measuring dimensions at anatomical landmarks - Definitive diagnosis of aortic dissection - Stratification of patients with complicated Stanford type B aortic dissection 2.2.4.3 TEVAR process - Sizing and planning - TEVAR procedure - Evaluating the results of the TEVAR procedure 2.2.4.4 Following up on the patients and assessing outcomes: + Early clinical outcomes: Survival rate, clinical events such as stroke, paraplegia (due to spinal cord ischemia), acute renal failure, vascular access complications, post-implantation syndrome + Mid-term clinical outcomes: Survival rates, major cardiovascular events, and revascularization rates + Results of early and mid-term aortic remodeling Area of the false lumen Area of the true lumen Figure 2.2 Measuring dimensions of true and false lumens after TEVAR Evaluating diameter and area of the true lumen, false lumen, and the entire aorta on a plane perpendicular to the flow at anatomical landmarks by Centerline rendering method Evaluating the degree of false-luminal thrombosis 2.2.5 Statistical methods: Continuous variables were summarized with medians and ranges, and categorical variables with frequencies Categorical data were analyzed by Fischer’s exact test; for continuous data comparisons, the t-test or Mann Whitney test was used The Kaplan Meier method was applied to calculate lifetable estimates for death and events Hazard ratios (HRs) were calculated using Cox regression, for both the survival data and failure analysis Stata version 16.0 MP was used for data processing and statistical analyses Chapter RESULTS From January 2014 to December 2020, a total of 102 acute complicated TBAD patients who underwent endovascular intervention with stent grafting for the treatment met the research criteria to participate in our study 3.1 Patient characteristics 3.1.1 Clinical characteristics Table 3.1 Clinical characteristics of patients Characteristic (n=102) Age Sex (male) Hypertension Smoking Rối loạn lipid máu History Diabetes Stroke Chronic kidney disease Chest pain At the onset (VAS) At the time of admission SBP at the time of admission Blood DBP at the time of admission pressure Number of drug use At the time of admission Heart rate After treatment Beta-blockers Calcium channel blockers Angiotensin-converting enzyme inhibitors Drugs Angiotensin II Receptor Blockers Diuretics Alpha-2 adrenergic receptor agonists n % (Min-max) 57,6 ± 10,4 33 - 86 91 89,22 81 79,41 72 70,59 8,82 3,92 1,96 1,96 7,7 ± 1,1 5-9 5,9 ± 0,9 3-8 164,5 ± 31,0 100 - 240 90,9 ± 14,4 50 - 120 4±1 2-6 82 ± 15 45 - 120 70 ± 50 - 100 102 100 92 90,2 26 25,49 67 40 29 65,69 39,22 28,43 Comment: Hypertension was the most common risk factor (79.41%) The mean age was 57.6 ± 10.4 The majority gender is male (89.2%) The symptoms at the onset are very intense (VAS Pain Scale 7.7 ± 1.1 points) 3.1.2 Characteristics of the original tear and the extent of damage to the aortic dissection Table 3.2 Characteristics of aortic dissection Characteristic (n=102) Primary entry tear size (mm) Dissection extending past the aortic bifurcation Minimum true lumen diameter (mm) Minimum true lumen area (mm2) Maximum false lumen diameter (mm) False lumen diameter > 22mm Maximum false lumen diameter (mm2) Maximum diameter of aorta (mm) Descending aorta diameter > 40 mm Minimum area of descending aorta (mm ) Distance from left subclavian artery to celiac trunk (mm) n % (Min-max) 16,09 ± 12,02 3-70 75 73,53% 10,7 ± 5,2 – 25,5 164,7 ± 91,7 – 512 23,7 ± 9,6 7,7 – 61,2 47 46,08% 831,0 ± 599,5 58 – 4207 38,2 ± 7,7 27,9 – 75,4 23 22,55 1203,9 ± 592,0 (577 – 4465) 257,9 ± 20,8 207 – 319 Comment: 102 Stanford type B aortic dissection patients have the mean size of primary entry tear 16.09 ± 12.02 mm The true lumen was compressed with the mean minimum true lumen size of 10.7 ± 5.2 mm The false lumen was greatly dilated with the mean maximum diameter of 23.7 ± 9.6mm 3.1.2 Characteristics of complications Table 3.3 Characteristics of complications Complications (n=102) Number (n) Proportion(%) Uncontrolled systemic hypertension 37 36,27 Refractory pain 20 19,61 Rupture 18 17,65 Malperfusion syndrome 50 49,02 Comment: In 102 patients with complicated Stanford B aortic dissection, the number of patients with ischemic complications accounted for the highest rate of 49.02% 11 3.2.2 Mid-term results 3.2.2.1 Survival rates of major adverse cardiovascular events with follow up Figure 3.2 Kaplan Meier plot for survival rates of MACE (n=102) Comment: The risk of major adverse cardiovascular events (MACE) increased gradually with follow-up, about 10% at month 10 and 20% at month 40 Table 3.6 Major adverse cardiovascular events with follow up Event (n=102) Number (n) Proportion (%) Death 11 10,78 Re-intervention of aorta 3,92 Hospitalization due to coronary 2,94 artery disease Hospitalization due to heart failure 0 Stroke 3,92 MACE 22 21,57 Comment: A total of patients required revascularization of the aorta There are three patients hospitalized for coronary artery disease with indications for coronary angiography and intervention 12 3.2.2.2 Survival rates of death with follow-up Biểu đồ 3.3 Kaplan Meier plot for survival rates of death (n=102) Comment: The average follow-up time of the patients: 37.6 ± 22.3 months (from to 89 months) A, Evolution of the diameter of the false lumen, true lumen, and overall size of the descending aorta over time Mean diameter(mm) Evolution of the diameters over time 50 38,2 38,8 36,4 36,2 30 23,7 22,2 25 26,4 35,8 27,2 20 10,7 13 7,7 6,8 5,9 Before TEVAR Before Discharge After month After months After 12 months 40 10 Time follow-up Minimum true lumen Maximum false lumen Maximum descending aorta Figure 3.4 Evolution of the diameter over time Comment: True lumen diameter increases over time False lumen diameter gradually decreased after TEVAR 13 3.3 Factors associated with TEVAR results 3.3.1 Factors associated with early complications 3.3.1.1 Factors associated with spinal cord ischemia after TEVAR Table 3.7 Factors associated with spinal cord ischemia after TEVAR n (%) Risk factor Non ischemia (n=97) Ischemia Total (n=5) (n=102) OR 95% CI p* 1,03 0,95-1,13 0,449 Age (years) 57,4 ± 10,5 61,0 ± 7,6 57,6 ± 10,4 Uncontrolled hypertension 37 (38,1%) (0%) 37 (36,3%) - - 0,099 Refractory pain 20(20,6%) 0(0%) 20(19,6%) - - 0,580 Malperfusion syndrome 46 (47,4%) (80,0%) 50 (49,0%) 4,43 0,48-41,13 0,190 Rupture 16 (16,5%) (40,0%) 18 (17,7%) 3,375 0,521-21,85 0,202 Acute renal failure 10 (10,3%) (20,0%) 11 (10,8%) 2,18 0,22-21,41 0,505 Stent type: Relay 51(52,6%) 2(40,0%) 53(52,0%) 0,60 0,10-3,76 0,587 Coverage length ≥ 270 mm 6(6,2%) 2(40%) 8(7,8%) 10,11 1,41-72,55 0,021 Coverage of the left subclavian artery (without revascularization) 77(79,4%) 5(100%) 82(80,4%) - - 0,328 (0%) (60%) (2,9%) - - 22mm Oversize ratio (%) Carotid-subclavian bypass Chimney technique Coverage of the left subclavian artery (without revascularization) Stent type: Relay n (%) Non-MACE MACE (n=80) (n=22) (8,6%) (18,2%) 56,8 ± 10,5 60,5 ± 9,7 19 (23,8%) (27,3%) 31 (38,8%) (27,3%) 17(21,3%) 3(13,6%) 36 (45,0%) 14 (63,6%) 11 (13,8%) (31,8%) (6,3%) (27,3%) HR 95% CI 2,25 1,03 1,17 0,62 0,77 1,51 2,46 5,64 0,75-6,78 0,99-1,08 0,46-3,00 0,24-1,60 0,23-2,64 0,61-3,71 0,99-6,11 2,12-15,03 0,151 0,145 0,740 0,326 0,681 0,369 0,052 0,001 23(22,6%) 1,81 0,73-4,49 0,201 36 (45,0%) 8,6 ± 3,0 7(8,8%) 2(2,5%) 11 (50,0%) 47 (46,1%) 1,45 0,61-3,42 8,0 ± 3,4 8,5 ± 3,0 0,96 0,83-1,10 2(9,1%) 9(8,8%) 1,32 0,31-5,73 0(0%) 2(1,96%) - 0,401 0,560 0,708 0,613 62(77,5%) 20(90,9%) 82(80,4%) 2,90 0,62-13,62 0,176 43(53,8%) 10(45,5%) 53(52,0%) 0,96 0,40-2,31 16(20,0%) 7(31,8%) Total (n=102) 11 (10,8%) 57,6 ± 10,4 25 (24,5%) 37 (36,3%) 20(19,6%) 50 (49,0%) 18 (17,7%) 11 (10,8%) p* 0,928 p*: Use Fisher’s exact test in the case can not perform Cox regression 15 Comment: Acute renal failure after intervention increased the risk of MACE events (p=0.001) 3.3.2.2 Survival rate over time and associated factors Table 3.10 Factors associated with death Risk factor n (%) Survival Death Total (n=91) (n=11) (n= 102) (8,8%) (27,3%) 11 (10,8%) 56,9 ± 10,1 63,9 ± 11,1 57,6 ± 10,4 23 (25,3%) (18,2%) 25 (24,5%) HR 95% CI p* Sex (Female) 3,27 0,87-12,32 0,081 Age (years) 1,07 1,003-1,14 0,040 Heart rate > 70 bpm 0,69 0,15-3,19 0,634 Uncontrolled 35 (38,5%) (18,2%) 37 (36,3%) 0,36 0,08-1,65 0,188 hypertension Refractory pain 19(20,9%) 1(9,1%) 20(19,6%) 0,42 0,05-3,32 0,414 Malperfusion 44 (48,4%) (54,6%) 50 (49,0%) 1,23 0,38-4,04 0,730 syndrome Rupture 12 (13,2%) (54,6%) 18 (17,7%) 6,90 2,09-22,80 0,002 Acute renal failure after (7,7%) (36,4%) 11 (10,8%) 5,37 1,57-18,38 0,007 TEVAR Ascending aorta (3,0%) (0%) (2,94%) 0,708 diameter > 42mm Descending aorta 18 (19,78%) (45,45%) 23(22,55%) 3,15 0,96-10,34 0,059 diameter > 40mm False lumen 41 (45,1%) (54,6%) 47 (46,1%) 1,46 0,45-4,80 0,529 diameter >22mm Primary entry tear 16,1±12,2 16,2±10,8 16,1±12,0 1,003 0,96-1,05 0,892 diameter (mm) Oversize ratio (%) 8,6 ± 3,1 7,8 ± 2,1 8,5 ± 3,0 0,93 0,77-1,13 0,465 Stent type: Relay 48(52,8%) 5(45,5%) 53(52,0%) 0,77 0,24-2,53 0,670 Comment: Rupture complications were associated with an increased risk of death (p=0.002) Older age and acute renal failure after intervention are factors that increase the risk of death (p
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