Nghiên cứu đánh giá kết quả phẫu thuật thay van hai lá bằng van cơ học st jude tại bệnh viện trung ương quân đội 108 tt tiếng anh

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1 INTRODUCTION Mitral valve disease is the most common valvular heart disease in our country, mainly due to rheumatic heart disease Most patients with this valvular heart disease will get heart failure at labor age and become a burden for families and society The appearance of the extracorporeal circulation machine in 1953 allows safe access and regeneration of heart chambers while cardiovascular surgery has been strongly developed, along with the design and improvement of prosthetic cardiac valve The first valve generation was Starr - Edwards (1961); the single-wing disc valve (1969), double-wing disc valve (1977), bio-artificial valves were also developed In our country in 1958, Professor Ton That Tung made a replacement of mitral valve and since 1971, there have been many domestic cardiac surgery centers where almost the cardiac surgeries have been carried out The St.Jude mechanical prosthetic heart valves has been still commonly used thanks to high strength and good hemodynamics However, improvements in mechanical valves, technical changes and differences in disease structure, management organization, care, surgery and postoperative follow-up in each hospital have not been fully studied 108 Military Central Hospital is the first unit in the Army to perform cardiac surgery, therefore, it is very necessary to make such evaluation For the above reasons, we carry out the topic with following objectives: Commenting on clinical and subclinical characteristics of patients under the surgery of mitral valve replacement with St.Jude mechanical valve Evaluating the surgical results for replacement of mitral valve with St.Jude mechanical valve at 108 Military Central Hospital CONTRIBUTIONS OF THE THESIS - The findings enrich the study results on clinical and hemodynamic characteristics, contribute to the application into clinical cardiovascular practice in and out of the Army 2 - The study has provided basic information about the surgical results for mitral valve replacement with St.Jude mechanical valve at the 108 Hospital - the Army’s first hospital that performs cardiac surgery as a basis for evaluating the efficiency of the procedures of preparations for surgery, resuscitation and post-operative follow-up at the hospital THESIS STRUCTURE The thesis consists of 122 pages (excluding appendices and references), including main chapters: Introduction: pages, chapter – Overview: 33 pages, chapter - Objects and study methodology: 21 pages, chapter – Findings: 29 pages, chapter – Discussion: 34 pages, conclusions and recommendations: pages The thesis has 50 tables, 20 charts, 18 illustrations, diagram, 146 references, including 37 Vietnamese documents and 109 English documents CHAPTER 1: LITERATURA REVIEW 1.1 Applied surgical anatomy of mitral valve The mitral valve (MV) is also called the left atrioventricular valve, consisting of valve rings, valve leaflet, ligaments, and muscle chains: - The valve-atrial junction: the location where the valve leaflet is connected with the left atrium In surgery, it is based on the difference in color between the left atrium - LA (light pink) and valve leaflets (light yellow) to locate valve position The anterior valve ring is very thick and firm, which is the insertion for the anterior leaflet of mitral valve, however the contiguous area between mitral valve and the aorta valve has almost no valve rings The posterior valve ring is the location to which the posterior leaflet of MV adheres and it is a weak and easily relaxed position in MV cases In MV surgery, it should be noted: (1) The circumflex artery: running between the background of the left auricle and the anterior valve edge for about 3-4 mm from the joint of the valve - atrium, then running away from the posterior valve ring (2) Coronary sinuses: running along the posterior valve ring, initially outside the artery, then crossing the artery to go inside, about 5mm from the valve ring (3) His bundle: located near the right fiber triangle (4) The non-coronary leaflets and left coronary leaflets of aortic valve (AV): closely related to the background of anterior leaflets of mitral valve before; the root of these valves is – 10 mm from the VHL ring - Valve leaflets: the anterior leaflet is big while the posterior leaflet is small Carpentier divided each valve leaflet into three sections, which is very meaningful in surgery - Valve suspension system: muscle chain with shrinkage function and ligaments with elastic properties to hold the valve leaflets and ventricle's contraction function Especially when cutting mitral valve, it should be noted to avoid excessive pulling, which causes cracking of the papillary muscles, which can cause ventricle type (according to Treasure’s classification) - Ligament system: including anterior leaflet ligament and posterior leaflet ligament One point should be noted is that the anterior leaflet ligament cling to the rough area, the background of the posterior leaflet, therefore, it should be noted for preservation in mitral valve surgery 1.2 Diagnosis of mitral valve disease - Causes: mainly due to rheumatic heart disease (RF); the frequency of RF and heart valve disease due to RF at the rate of 0.2 to 18.6 ‰ in the number of schooling children - Clinical developments: Moderate double-leaflet stenosis usually does not show symptoms for about 10 years The first and common symptoms are difficult breathing, then right heart failure Listening to the heart: T1 sound is strong at the promontory; diastole vibrates; if the pressure of pulmonary artery (PAP) increases from moderate to high level, T2 sound seems strong and split, anterior systolic murmurs, clắc sounds, Graham-steel murmurs, Untreated double-leaflet complications: 60-70% pulmonary edema, 20-30% systemic embolism, 10% pulmonary infarction, 1-5% infection ECG: P wave is wide with peaks, cardiopulmonary x-ray: See big heart; echocardiography is a basic test to diagnose and assess the severity of the disease Mitral incompetence (MI) is divided into acute MI and chronic MI with causes, clinical course and different settlement methods Acute MI: usually due to ligament rupture or post-traumatic papillary muscle, infection, infection, anemia or idiopathic situation, clinical expressions are severe due to sudden ventricle failure; the mortality rate is 6.3% per year Chronic MI: Usually not showing functional symptoms, heart failure after 6-10 years, therefore, when there are functional symptoms, the ventricle dysfunction has not recovered, increasing complications such as heart failure, death Determining the MI mechanism is very important: If the central MI line accompanied by a normal MV structure, it shows that the mechanical MI flow is often due to the dilatation in valve ring, ventricle or the limitation in movement of posterior leaflet of MV due to dyskinesia in the ventricle in patients with CAD and if MI line has the eccentricity accompanied with abnormal MV structure show an open line due to physical injury Other authors: open line width through openings is a reliable indicator; If this indicator is ≥ 0.7 cm in width, it is evidence of severe MI 1.3 History of development of mechanical mitral valve and St.Jude valve 1.3.1 Classification, some prosthetic heart valve indicators Prosthetic heart valves include mechanical and biological valves The area indicators of artificial valves include: GOA, COA, EOA in which EOA is most concerned because this is the amount of blood through the valv ; This indicator is usually taken over m² of body skin area (IEOA) For the MV, this indicator is 1.2 cm²/m²BSA and the inappropriate valve will be replaced if IEOA is < 0.9 cm² / m² 1.3.2 St.Jude prosthetic mechanical valve It is the preferred double-wing valve in North America, Europe and our country has the superiority in durability, large EOA, minimum flow resistance and few side effects Teh structure include: Valve frame: Graphite and carbon coated Valve wing: Semicircle and straight, made of graphite mixed with tungsten for optical resistance and also covered The valve wing coupling protrudes from the valve rin, therefore, it is convenient to select in small ventricle cases while still ensuring IEOA index Valve rings: very thick and firm When it is open: creating an opening angle of 85o (central), therefore, the EOA is big and significantly reduces eddy current and diastolic pressure difference through the valve When it closes: creating a closed angle of 30-35º compared to the valve ring plane 5 1.3.3 The determinants of choosing the prosthetic heart valves instead of MV Selection of prosthetic heart valves needs to ensure the factors: good hemodynamics, high durability, avoiding the risk of thrombosis and convenience for surgeons Age is the first factor to select biological valves or mechanical valves, compliance with the use of anticoagulants, size and damages to valve rings 1.4 Current mechanical mitral valve replacement surgery 1.4.1 Recommendations and indications for treatment of MV disease Cardiovascular associations offer types of promotion: Type I recommendation: should be implemented because the benefit is much higher than the risk (proven evidence) Type II recommendation: Type IIa should be implemented because the benefit is higher than risk, however, more researches are needed for affirmation (evidence proved from a multi-center study but limited, with or without randomized test) Type IIb should be considered because benefits may be higher than risk, however, the big multi-center studies are needed (Evidence has been proven but the level is still very limited, only in small studies or expert opinions) Type III recommendation: should not be implemented because the risk of more benefits Indications is based on ACC / AHA recommendations 1.4.2 Some new methods of mechanical mitral valve replacement Endoscopic surgery for mitral valve replacement, transcutaneous mitral valve replacement and robot surgery have been studied and developed with modern equipment will be a gradual trend to replace open heart surgery Short-term results well improves in hemodynamics, clinical aspects and long-term results are still under investigation and no relevant published results have been published However, a research report at 32 centers: premature death rate (30 days): 12.5%, ventricle entry blockage: for transcutaneous mitral valve replacement: 9.3% 1.4.3 Complications and treatment follow-up after surgery - Complications related to open heart surgery (related to CEC, bleeding, bacterial infection) and related to mechanical MV (ventricle rupture, coronary injury, obstruction of ventricle exit line, valve edge opening, embolism, antifreeze aspect, etc) Control of complications depends on the experience, skills of the surgeon, the professionalism of nurses and management coordination, periodic folow-up and examination, anti-coagulation compliance - Long-term monitoring and treatment for the patient with mechanical valve: good coordination is needed between patients and physicians such as regular examination; nutrient-rich diet; regime of physical activity, proper working and strict adherence to anticoagulant medicines, prophylaxis, heart rate control and Dressler syndrome, etc 1.5 Research results of mechanical mitral valve replacement - Mortality rate: author Ikonomidis J.S has made the St.Jude mitral valve replacement at 5.3% for 20 years, 1.3% by Kandemir O for the first 30 days Mortality rate is closely related to preoperative cardiac function, age, and coronary disease and may be related to the preservation technique of leaf ligament after MV because when the whole apparatus is removed below the valve, the rate of the ventricle rupture is 14% (1990) - Other complications have a low rate; Emery states that: thrombosis rate is 0.5%, infective endocarditis is 0.2% and pannus is 0% Author Ikonomidis J.S have treated 359 patients over the past 20 years: Valve-related mortality rate of 0.2%, embolism of 3%, hemorrhage of 2% and infective endocarditis of 2% Similarly, Remadi J., over the past 19 years of treatment, thrombosis is 0.69%/ year, hemorrhage is 0.2%/year Author Do Kim Que did not see hemorrhage or heart valve thrombosis 1.5.2 Postoperative hemodynamic after mechanical MV replacement There are many studies on teh eraly hemodynamic changes after mechanical MV replacement, however, there are very few studies on clinical and hemodynamic changes in the medium and long term: Saad Bader has shown a significant improvement in NYHA levels, RN rate, NT size; the decerasing PAP is very meaningful at months after surgery The longest study by Emery R.W during 25 years (1,498 patients): SJM valve brings the best hemodynamic results, improves the clinical condition and patient's quality of life Author Nguyen Duc Hien: Heart failure condition and PAP improve well, which is similar to the comments of author Rodrigues A.J Author Do Kim Que, after years of study, shows that St.Jude MV works well, which is similar to teh study results by Remadi J.P over 440 patients and author Emery R.W has not recognized any mechanical damage of St.Jude valve for 25 years of research Author Ikonomidis J.S shows that the SJM mechanical valve is a reliable and durable mechanical valve Many domestic authors have studied the post-operative results to replace the prosthetic mitral valve However, these results are still not homogeneous in terms of time; follow-up time is not long, and a followup and evaluation procedure needs to be more systematic In addition, there are different characteristics such as: external apperance of disease, treatment according to route (Army and civic scope), difference in cardiac surgery and resuscitation, etc and structural characteristics of St Jude valve with the surgeon's skills in surgery; the studies evaluating the results will be necessary to help evaluate the process, build up the team and serve the Army and the people CHAPTER 2: SUBJECTS AND STUDY METHODS 2.1 Study object 2.1.1 Criteria for selecting patients All patients have St.Jude mechanical MV replaced with or without VBL shaping at 108 Hospital from 05/2010 to 12/2014 Standard for patient grouping: MV is main, MI ≤ 1/4, called MS group; simple MI; The coordination between MS and MI /4 2/4, is called MSI group 2.1.2 Exclusion criteria + The patients that have MV replaced with St.Jude mechanical valve but with other diseases such aortic valve disease under the requirement of surgery treatment or congenital heart disease + Patients with MI after myocardial infarction + Patients who not have sufficient information in the record or not agree to participate in the study 2.2 Study Methods 2.2.1 Study design: Study, describe series of cases, intervention, follow-up and non-control 2.2.2 Study criteria: - Pre-operative study criteria: General characteristics such as age (> 60 and ≤ 60 years); urban and countryside areas; RF (according to Jones 1988 criteria); prehistory of MV intervention (MV dilatation, closed heart surgery); ASA incision infection risk scale; Favorable prognosis for placing Mallampati intubation and prognosis of mortality rate in heart surgery through Euro Score scale Clinical characteristics: Degree of heart failure according to NYHA Subclinical characteristics: ECG: (sinus rhythm-SR, atrial fibrillation-AF), echocardiography: LA diameter (measured on TM type ultrasound from the section along the axis of the standard chest, through the orgin of o the aorta when the aortic valve closes, normally: 28 ± 4mm), Dd, Ds, PAPs (PAPs = Gmax (HoBL) + 10(mmHg), other vulnerability levels: MS, MI, tricuspid incompetence (based on 2008 standard of the Vietnam National Heart Association) Wilkins scale and evaluation of the prosthetic valve operation is based on the American Society of echocardiography Table 2.1: Function parameters of prosthetic mitral valve Parameters Normal Possible stenosis Severe stenosis suggestion Gmean (mmHg) ≤5 – 10 > 10 MVA (cm ) ≥2 1–2 200 - Surgical procedure and research criteria: + Pre-operative preparations: Within 01 day before surgery, it is necessary to guide for disinfection bath with Chlorhexidine 4% solution and use sterile clothes of hospital, abstain from food for 12 hours before surgery, enemas and stop anticoagulants + Step 1: Open the chest: Open into the mediastinum along the vertical line between the breastbone, open the pericardium, reveal the heart Anticoagulation with systemic Heparin (3 mg/kg body weight) reaches the ACT > 400 'standard to run the extracorporeal circulation machine, tighten the cardinal veins, repair the aorta Transmission of cardiac paralysis solution through the original of aorta * Regarding on the domestic studt criteria, this surgery include: protecting heart muscle hypothermia with cold crystal solution or not making hypothermia with warm blood 9 + Step 2: Approaching to MV: Path of opening classic atrial and RA - septum atriorum- LA * The study criteria include: incision, LA thrombosis, left auricle, and MV sytem damage + Step 3: Replace MV with St Jude: Cutting off the MV, preserving part or all of the MV apparatus, posterior leaflet and ligament of posterior leaflet Hospital 108 uses St Jude valve, type of Saint Jude Masters introduced in 1995 with valve sizes of 27, 29, 31 Measuring artificial valve size with a specialized rule set of Saint Jude firm Sew to fix the St Jude valve ring with MV ring with U-shape sutures, checking the tightness between artificial valve ring and mitral valve ring, seam tightness and operation of artificial St Jude valve wing Combination surgery: repair TV * The research criteria in this surgery include: (1) Preserving the posterior leaflet, preserving the ligament of posterior leaflet: yes or no (2) Size of St Jude artificial two-leaf valve used (3) Correction of TV: correction method (4) The result of heartbeat beating again after clamping the aorta: natural, electric shock, Pace machine + Step 4: Heart beats again: Close the heart opening lines (closing LA and RA) Drawing canuyn of veins, aorta, drawing the left heart drain to neutralize heparin with protamin sulfate * The research criteria in this surgery include: (1) Heart beats again naturally, supports Pace or electric shock (2) Heart rate when beating: sinus or AF (3) Time for circulation outside the body (minutes): from the time of starting the machine to stopping the machine (4) Aortic clamping time (minutes): from the start of clamping aorta to the time of removing the aortic clamp (5) Number and location of drains: on the heart, behind the sternum, pleural cavity + Step 5: Close the incision: Close the heart membrane, sternum * Research criteria include: (1) Time of surgery (minutes): starting from the incision to the end of skin suture - Monitoring process and early evaluation criteria after surgery: + Treating according to cardiovascular resuscitation regimen, tracking live functions on Monitor Philips and recording monitoring sheet) with indexes: blood gas, electrolytes, liver and kidney function, blood formula immediately after returning to the recovery room for 10 15-30 minutes Anticoagulant (heparin) immediately after 6-8 hours after surgery if the risk of bleeding is over Combining heparin with vitamin K resistance in the first 1-3 days after surgery, then maintaining vitamin K and adjusting dose according to INR, TP, APTT test results * Research targets: (1) vasomotor (dose); (2) Time of mechanical ventilation (hours): Calculated from the beginning of the use of the ventilator until the removal of the ventilator: 24 hours (3) Active resuscitation period (days): from the time when the patient is moved to recovery room until returned to treatment ward ( days) (4) Complications: Early death after surgery; Repeat operation due to bleeding, bleeding location: When blood flow through chest drain > 5ml/kg/ hour lasts for the first hours after surgery; Low cardiac output syndrome (LCOS); Infectious complications: pulmonary infection due to mechanical ventilation often appear after 48 hours and based on the standards of the American Thoracic Society; Complications related to artificial mitral valve: valve blockage due to thrombosis (according to ACC/AHA guidelines), disproportionate between artificial valve size compared to patients (IEOA < 0.9cm²/m² BSA) , hemolysis (appear jaundice - mucosa, dark urine and reduced red blood cell and Hb, patients without a history of hemolysis, broken ventricles ; Complications related to surgery: coronary artery lesions ; Temporary oliguria: urine < 1ml/kg/hour, respond well to high-dose diuretics, stable hemodynamic patients and no pre-operative renal disease history; Renal failure requiring dialysis after surgery: determined by biochemical index: blood urea above 8.3mmol/l; Blood creatinine above 115 mmol/l Internal treatment, peritoneal dialysis or hemodialysis Liver failure after surgery: determined if after surgery, there is a sign of jaundice, rapid increase mucosa, dark urine and hepatic cerebral syndrome division of I to IV) and high liver enzymes: GOT, GPT, Bilirubin, time Prothrombin prolonged ≥ 1,5; Gastrointestinal bleeding after surgery: is determined if there is blood clots, black and pasty feces with ill-smell in the vomitting fluid and anaemia In addition, complications of pleural effusion, pleural cavity; 11 complications of pericardial effusion; Acute heart failure, acute cardiac tamponade (BECK trisomy) was also monitored during this period - Indicators and evaluation results after surgery: Patients were instructed to monitor and treat after surgery according to a unified procedure at 108 Hospital, including: Re-examination time: usually recheck on Friday every week as recorded in the examination book every week of the first month after surgery, every months of the following months and every months of the following years The examination and subclinical content needed to be recorded in the monitoring book: (1) Symptoms: dyspnea, chest pain, arrhythmia, discomfort due to mechanical valve noise, symptoms of right heart failure, hemorrhage, embolism; (2) Degree graduation of heart failure according to NYHA; (3) Status of sternum incision; (4) Subclinical: INR test Electrocardiogram (determination of arrhythmia: sinus or non-sinus) and cardiopulmonary x-ray (with manifestations of lung disease such as inflammation, pleural effusion ) and cardiac Doppler ultrasound: indicated at least once a year The indicators to focus on are MVA, NT, Dd, Ds, PAPs, pressure difference through St Jude MV and the degree of TV opening Other tests such as biochemistry, hematology (designated at least 01 time/year) (5) Complications after surgery * Research targets include: (1) Heart rate at the time of follow-up: heart rate at times through heart examination and hearing, suspected cases of arrhythmia will conduct an ECG to determine: SR; AF and other rhythms (2) Clinical symptoms: heart failure degree graduation according to NYHA (3) Transthoracic Echocardiogram: working status of St Jude valve; Ventricular size (Dd, Ds); Ventricular function (EF% index); Pressure is different through St Jude mechanical MV; Pressure on systolic right artery; Status of TV open; Area of St Jude (4) Postoperative drug use status: anticoagulants, cardiac drugs, diuretic, beta blockers, tranquillizer, antihypertensive ) (5) Complications at the time of follow-up after surgery: Complications due to the use of anticoagulants: cerebral hemorrhage; gastrointestinal bleeding; subcutaneous, external meatus hemorrhage or tooth root bleeding Complications from thrombosis: cerebral infarction stroke; Peripheral vascular occlusion complications, artificial valve thrombosis (abnormal dyspnea, unclear mechanical heart valve, echocardiography found the movement of leaflet is restricted) Complications related to artificial 12 valves: mechanical failure; hemolysis; disproportionate mechanical valve and heart (IEOA < 0.9cm²) Other complications: infection; hemodynamic disorders, conduction; bacterial endocarditis; pannus + Evaluation on artificial MV echocardiography is unusual if: The valve wing restricts movement or uneven opening - closing; Appeared edge valve; Differential pressure through valves > 10mmHg; Valve hole area < 1.8cm²; Some other indicators: top speed of blood flow through the valve > 2.5msec; Part-time pressure (PHT) > 18msec (if available) + Operation of artificial MV: Good: Valve is in the right position and operates normally (with clinical and subclinical parameters within normal limits) Not good: The movement of the two leaflets is restricted + Artificial valve thrombosis (according of AHA/ACC): 2.3 Data analysis Data collection is done in a unified form, entered and analyzed by SPSS 16.0 software to calculate parameters: average, variance, standard deviation CHAPTER 3: RESEARCH RESULTS 3.1 General characteristics of the research group - Average age: 48.1 ± 9.2 years old, male: 47.0 ± 10.5 years old and female: 48.7 ± 8.3 years old Female is more than male, female/male = 1.7 Rural area is more than urban, a history of low heart rate accounts for 68.9%, of which 33.6% is treated, 16.4% of patients is conducted percutaneous mitral valve dilatation, 5.7% of closed heart surgery - Mallampati I index mainly with 92%, without Mallampati IV The risk of high incision infection: ASA is 92.6% and ASA is 2.5% Stratified risk of death after surgery 1% -2% accounts for 77.1% 3.2 Clinical and subclinical characteristics - Clinical characteristics: Heart failure level according to NYHA: NYHA III accounts for 34.4%, NYHA II accounts for 65.6% The first and common symptoms is dyspnea (96.7%), chest pain (92.6%), right heart failure (44.3%) - Subclinical features: On the ECG, AF (65.6%), SR (34.4%) X-ray images: heart-chest index (> 65%) accounts for 82.8% 4.1% of patients have pleural effusion Results on echocardiography: MV disease: Mainly with MS, accounting for 81.2%, 11 (9%) patients with MI and 13 (10.7%) with MS 13 + Image of MV lesions: valve edge: thick and sticky (92.6%), calcified (33.9%), and defective (0.8%) Ligaments: thick (87.6%), contracted (81.1%), broken (2.5%) MV: thick and sticky (95.9%), calcified (74.6%), contracted (69.7%), valve prolapse (4.1%), swell with pustules (1.6%) + Some ultrasonic indicators: Table 3.1 Preoperative echocardiographic indicators (n = 122) Characteristics Min Max Average Left atrial diameter (NT) (mm) Left ventricular end diastolic dimension (Dd) (mm) Left ventricular diameter systole (Ds) (mm) Right arterial pressure systole (PAPs) (mmHg) EF index (%) Right ventricle (TP) (mm) 28 31 83 92 53.7 ± 10.6 49.3 ± 9.4 24 58 32.9 ± 6.7 20 27 18 102 79 40 45.8 ± 15.9 60.1 ± 9.8 21.5 ± 4.6 Ultrasound results: dilated left atrium, lightly dilated left ventricle The left ventricular systolic function preserved with EF (%) is 60.1 ± 9.8 Pressure of systolic right artery increase moderately and severely + Wilkins lesions: The valve shape is preserved with Wilkins 8-10 points, accounting for 86.5% + Average difference in MV: The difference in MV pressure > 10mmHg, accounting for 93.7% + TV injury: Medium-severe TV lesions in MS account for 51.6% The table above shows that no incompetence and light incompetence of TV accounts for 48.4%, major tricuspid incompetence combined with the MS - incompetence: 80.3% + Some other lesions: LA and LA appendage thrombus (31.9%), moderate PAPs (23%), severe (13.1%), aortic valve opening 2/4 (5.6%) 3.3 Results of surgical parameters - Protection of heart muscle in surgery: hypothermia 32-33ºC with cold crystal solution (50.8%) and warm blood solution (49.2%) - Suitable mechanical MV replacement when IEOA> 0.9cm²/m² BSA (normally 1.2cm/m² BSA), the appropriate valve size ratio is 100% 14 Table 3.2 Use of St Jude mechanical mitral valve size (n = 122) Size of St Jude valve n Ratio (%) 27 2.5 29 63 51.6 31 56 45.9 Total 122 100 Table 3.3 Appropriate ratio of valve size with body skin area (n = 122) Size of St Jude valve Average skin area (m²) Theoretic EOA (cm²) IEOA (cm²/m²) Appropriate ratio n (%) 27 1.42 ± 0.10 2.43 ± 0.63 1.71 ± 0.23 (100) 29 1.47 ± 0.17 2.66 ± 0.26 1.80 ± 0.15 63 (100) 31 1.50 ± 0.14 3.08 ± 1.09 2.50 ± 0.78 56 (100) - The shortest time of aortic clamping is 30 minutes, the longest time is 180 minutes and the average time is 60.3 ± 26.5 minutes The circulation time is 95.6 ± 32.1 minutes - The incision line approaches the MV: Atrial drain - LA (91.8%), RA - atrial septum - LA (8.2%) - LA thrombosis: ratio (18%), lower than preoperative ultrasound - Preserving part or all of the posterior leaflet and ligament of posterior leaflet: 88.5% - TV formation: 108 Hospital mainly uses PTFE strip in forming TV, accounting for 76.0% (57/75), uses autologous cardiac strip accounting for 14.7% (11/75) No TV formation accounts for 38.5% - Heart rate: heart self-bear again (97.5%), SR (60.7%), comparison of rhythm with before cardioversion surgery with significance - Comparison of ultrasound results: valve damage, thrombosis, TV found that the difference was not significant (p > 0.05) 3.4 Early results after surgery of St Jude mitral valve replacement - Results of heart rate: Comparison of preoperative heart rate with postoperative and early postoperative periods: There is an increase in cardioversion, significant differences with (p < 0.05) SR (45.9%) - Hemodynamic status: assessed on sinus heart rate < 100ck/min and maximum blood pressure > 100mmHg with vasomotor in the unstable group 100% with combination of drugs, hemodynamic stabilization after surgery with 25 % unused, light dose (41%) 15 - Mechanical ventilation time is recommended < 12 hours (86.9%) Resuscitation period < days (76.2%) - The level of heart failure according to NYHA: Before heart failure surgery class II and III is 100%, monitoring the early results the patient's effort capacity is significantly improved p < 0.05, NYHA transferred to class I is 80.3% Table 3.4 Early Doppler echocardiography results after surgery (n = 122) Echocardiography index Min Max Average Left atrial diameter (mm) 20 77 43.4 ± 9.4 Left ventricular end diastolic dimension(mm) 31 93 47.5 ± 8.2 Left ventricular diameter systole (mm) 20 61 32.6 ± 7.3 Right arterial pressure systole (mmHg) 15 69 32.8 ± 9.3 EF index (%) 28 81 63.8 ± 5.6 TP (mm) 15 34 20.9 ± 3.3 LA is dilated, sizes of LV and ventricle vary slightly RA pressure increase slightly and LV systolic function is preserved Difference of LA size, right arterial pressure systole with p < 0.05 EF index increases after surgery with p > 0.05 Dd and Ds indexes are not different (p > 0.05) when compared with preoperative echocardiography - Early tricuspid incompetence after surgery: 76.0% (57/75) forming TV with PTFE strip, moderate and severe incompetence after surgery accounts for 9.3% (7/75) 38.5% of patients did not repair tricuspid valves in St Jude mechanical MV replacement surgery, moderate and severe tricuspid valve incompetence accounts for 10.6% - Average difference through St Jude 6.3 ± 3.4mmHg, 5-10 mmHg accounts for 87.7% - The rate of early complications is low with 4.1% of bleeding, 2.5% of valve edge openness, 2.5% of bacterial contamination, 9.8% of heart failure, 3.3% of multiple organ failure - The re-surgery rate is 4.9%, mainly sternal bleeding, 01 case of bleeding in the left atrial appendage, 01 case of placing drain in the RV 3.5 Results of periodic follow-up (54 months) The patient is made an appointment for examination as scheduled in the patient's monitoring book every Friday, the shortest follow-up time is months and the longest is 54 months 16 - Heart rate at the time of follow-up: SR increased slightly in the first 24 months after surgery: months (44.6%), 12 months (45.5%), 24 months (47 %) and the rate of reduction or instability at the time of follow-up is longer, but the difference was not statistically significant (p> 0.05) In contrast, the AF rate decreases after surgery and increases the rate or instability of follow-up from the second year after surgery - The level of heart failure according to NYHA: Figure 3.1 Degree graduation of heart failure according to NYHA Before surgery, 100% of NYHA II and III is converted to NYHA and I, after surgery > 64%, NYHA II rate is increased from the 24 th - SJM's activities: SJM is in the right position and operates with normal parameters, valve edge is not open, the pressure difference through the valve St Jude is good and normal right arterial pressure is rated as good and accounts for 100% - The operation sound of St Jude mechanical mitral valve: pleasant feeling, not affecting sleep of patients, accounting for 99.2% - Echocardiography at different times Table 3.5a Doppler echocardiography index at different times after surgery Echo -cardiography index NT (mm) Dd (mm) Ds (mm) PAPs (mmHg) EF (%) TP (mm) Before surgery 53.7 ± 10.6 49.3 ± 9.4 32.9 ± 6.7 45.8 ± 15.9 60.1 ± 9.8 21.4 ± 4.8 Average value month months 12 months n = 122 n = 121 n = 121 41.8 ± 8.6 40.2 ± 8.1 39.6 ± 7.2 46.6 ± 6.9 45.7 ± 6.0 45.3 ± 6.8 31.2 ± 5.8 29.3 ± 5.7 29.1 ± 5.3 31.5 ± 6.4 29.5 ± 4.9 29.1 ± 4.8 62.2 ± 7.9 63.9 ± 8.4 64.9 ± 7.1 20.6 ± 2.3 20.9 ± 4.4 20.9 ± 4.3 24 months n = 115 38.2 ± 7.3 45.9 ± 6.3 29.2 ± 5.3 29.5 ± 4.8 64.3 ± 9.2 21.3 ± 6.8 LA size; Dd; Ds; PAPs decreases gradually over time in 24 months 17 Table 3.5b Doppler echocardiography index at different times after surgery EchoAverage value cardiography 36 months 48 months 54 months Before index surgery n = 82 n = 34 n = 19 NT (mm) 53.7 ± 10.6 37.8 ± 5.6 39.9 ± 5.8 39.3 ± 4.9 Dd (mm) 49.3 ± 9.4 45.8 ± 5.7 46.8 ± 7.5 46.6 ± 8.8 Ds (mm) 32.9 ± 6.7 28.3 ± 4.5 28.5 ± 4.9 28.8± 5.2 PAPs (mmHg) 45.8 ± 15.9 29.6 ± 4.9 31.0 ± 8.2 29.7 ± 3.4 EF (%) 60.1 ± 9.8 66.4 ± 7.5 65.3 ± 6.2 65.2 ± 4.7 TP (mm) 21.4 ± 4.8 21.6 ± 6.5 21.5± 4.4 20.7 ± 1.1 Average echocardiographic index: LA size; Dd; Ds and PAPs increase gradually from the 36th to the 54th month, EF% index is stable Differential pressure across St Jude mechanical mitral valve: MONTH MONTHS 12 MONTHS 24 MONTHS 36 MONTHS 48 MONTHS 54 MONTHS Chart 3.2 The level of differential pressure across St Jude artificial valve Differential pressure through St Jude artificial valve mainly from - 10mmHg accounts for > 89% at the time of monitoring - Moderate - severe tricuspid valve incompetence after surgery: Ratio of tricuspid incompetence class II and III month months 12 months 24 months 36 months 48 months 54 months Group with tricuspid valve repair Group without tricuspid valve repair Chart 3.3 The level of tricuspid incompetence at the time of follow-up 18 The group that did not repair the TV had an increase in tricuspid incompetence, it’s different when compared with the group with TV repair at > 24 months (p < 0.05) - Complications at the times of follow-up: mild hemorrhage of 1.6% -5.3% at the time of follow-up, embolism at 12 months (0.8%), artificial valve thrombosis from 0.9% -6.1% limits the valve wing operation from 2.4% -6.1% Artificial valve edge incompetence appears 24 months after surgery at a rate of 0.9% -3.4% CHAPTER 4: DISCUSSION 4.1 General characteristics of the research team Age average: 48.1 ± 9.2, this is the age for performing the main work of the human and society, so if the St.Jude mechanical MV replacement surgery has good results, it will help patients improve symptoms and enhance the quality of life Gender and geography: the ratio of women/men is 1.7 according to WHO's meeting in Genevo: The frequency of HF does not depend on gender, race, or geography, but depends very much on the age, season, living conditions, socio-cultural levels and the role of Leukocyte Antigens DR4, which is more common in Asian women The 3-point ASA scale score (92.5%) indicates that there are severe systemic disorders, the risk of surgical wound infection, high complications and mortality (Wolters study) Stratify risk factors according to Euro Score, the risk of mortality after surgery in the study is estimated at 1-2% 4.2 Clinical and paraclinical characteristics 100% of patients have heart failure according to NYHA II and III, of which NYHA III is 34.4%, lower than other studies in the country The most common symptom is dyspnea, 96.7% with NYHA /4 2/4 at a rate of 100%, this result is similar to many domestic studies Syndromes of right heart failure and arrhythmia are also common in this group Paraclinical characteristics: AF (65.6%), according to ACC/AHA, the ratio of AF gradually increases with age, in some domestic reports, this rate is about 47.3 - 80% Echocardiography: MV regurgitation and stenosis account for 82%, suitable with studies showing that regurgitation and stenosis are common in the over-30 group The LA stretches, LV stretches lightly and PAP increase moderately, while the RV remains relatively normal 19 and the LV systolic function in most patients is preserved This result is similar to other studies Typical injury of the MV apparatus due to rheumatic heart disease with thickening, calcification and shrinkage accounts for a high ratio of over 69%, the synthesis of the lesion and mobile factors of the clinical valve often uses Willkins score, the results show that the valve morphology is preserved (86.5%), differential pressure across the valve > 10mmHg accounts for a high ratio (93.7%) TI (51,6%) The combined lesion such as moderate and severe TV regurgitation accounts for 51.6% The results of the foreign studies show that the actual frequency of secondary TV regurgitation is unknown, according to author Dreyfus G.D., the TV rings are abnormally stretched at about 50% 4.3 Surgical results At 108 Hospital, mainly using SJM in the position of MV, with valve size of 29 mainly, there is one author thinking that this valve size is suitable with MV size of Vietnamese adults Through IEOA analysis with valve size of 29 (1.80 ± 0.15) and valve size of 31 (2.50 ± 0.78), the studies show the suitability of mechanical valve size at the mitral valve position with patient's body is when IEOA is about 1.2cm², unsuitable when IEOA is < 0.9cm² A retrospective analysis shows that this unsuitablity is associated with congestive heart failure, PAP increase and survival rate decrease after MV replacement The technique of maximally preserving the valve tissue of the apparatus will help reduce the complication of left ventricular rupture, help stabilize the heart morphology and structure after the surgery Most authors have demonstrated that if posterior leaflet ligaments are preserved, ventricular function is better than cases which all ligaments are cut Creating a tricuspid valve when the valve ring size is > 35mm, at present most authors consider fixing the tricuspid valve very systematically from the point of view of Capentier A The heart beats itself again and turn rhythm into sinus with a rate of significant difference increase with p < 0.05 compared to the preoperative rhythm Author Le Ngoc Thanh: Predictors for successful rhythm turning include: age < 50 years old; time with AF < years; cardiac/chest index < 0.65; diameter of LA/longitudinal section on 20 echocardiography < 45mm; area of LA/4-chamber section area on echocardiography < 45cm² 4.4 Results after surgery of MV replacement with St.Jude mechanical valve Result on heatbeat: in the resuscitation period, SR after surgery is 56.6% compared with 34.4% before surgery with p 0.05) Some studies found that the rate of AF has not changed but other studies found a significant improvement in the rate of AF Following up heart rate at different times found that AF decreases early after surgery and is relatively stable at later times, coordinates treatment with internal Cardiologists for better effectiveness after surgery Therefore, many opinions suggest that AF intervention with MV surgery will have good results, reducing the rate of stroke after surgery The results of the study are also synonymous with improving heart failure and patient's exertion ability after surgery as commented by author Nguyen Hong Hanh The level of heart failure according to NYHA after surgery: markedly improved after surgery: NYHA I accounts for 80.3%, NYHA II accounts for 19.7%, marked difference in the level of heart failure before and after surgery with p < 0.05 Author Doan Quoc Hung has studied 243 postoperative patients, NYHA III - IV has improved from 68.2% to 10.2%, According to Kouchoukos N.T heart functions will improve markedly after surgery, the higher the rate of severe heart failure III, IV before surgery of any study results is, the lower the postoperative function is At follow-up times, NYHA tended to decrease immediately after surgery and lasted for years afterwards, however, the results showed that there was an increase in heart failure levels according to NYHA in the following follow-up months In the longer follow-up, the rate of NYHA II increased gradually from 20% to 50% 21 compared to the first years after surgery In years, NYHA I and II after surgery reached about 90%, equivalent to Remadi author's study on following-up after replacing St.Jude mechanical MV for 19 years, 89.4% NYHA I and II When comparing heart failure levels at the times of follow-up with the group with and without TR, it is found that there is an increase in the rate of heart failure levels in the group without TR, difference with statistical meaning with p < 0,05 On echocardiography: LA horizontal diameter and PAP were averagely decreased than before surgery, meaning with p 24 months after surgery with p < 0.05 Author Navia: the level of TV regurgitation increases gradually over time Therefore, author Correia said that "a valve not to be forgotten" in intervention of MV disease in the study on MV Our study results contribute to the suggestion to use PTFE strips in in TV formation to overcome fibrosis and non-softness caused by artificial valve rings Early complications after surgery and re-operation: Death 0%, acute heart failure 9.8%, bleeding 4.1%, Valve edge regurgitation 2.5%, infection 2.5% Results of Baumgartner J.F, this rate in years is about 5% The rate of postoperative bleeding in the research has changed quite a lot in cardiovascular surgery centers from 1% to 26.2%/year 23 Although the rate of postoperative bleeding is easy to see in patients using anticoagulant, this is a very unfortunate complication and can be limited by good hemostatic techniques during and after surgery Adjusting anticoagulant to achieve the right effect for each patient, however, the goal of achieving effective threshold is not simple Table 4.1 Compare the rate of complications associated with anticoagulation Studies Bleeding Vascular occlusion (% patients-year) (% patients-year) Takanabu Mori 25.5 Remadi J.P 0,69 Doan Quoc Hung 2.18 This study 4.1 The surgical rate accounted for 4.9% of which postoperative bleeding accounted for 83.3% such as auricle bleeding, post-sternal bleeding Surgical complications occur in 01 case of the drainage of the pericardium into the right ventricle causing acute cardiac tamponade promptly detected, this is a serious complications, high mortality rate Bui Duc Phu author bleeds 4.1% and needs an operation Most reports not see bleeding from the heart's stitches but we met a patient who blew at the auricle Serious complications such as left ventricular rupture were not seen in this research, the average rate was 1.2% and the mortality rate was 75% According to Garcia-Fuster the protection of the posterior leaflet, part or all of the ligaments will reduce the risk of left ventricular rupture and mortality after surgery Valve thrombosis, thrombosis, limiting artificial valve movement occur at any time: the rate of artificial MV regurgitation decreases with the research months from 5.2% (January) to % (4th year), mechanical mitral thrombosis appears scattered and may limit or limit SJM movement Author Remadi J.P 19-year study of 440 patients replaced van St.Jude: blood clot rate of 0.2% /year CONCLUSION Studying 122 patients received MV replacement with SJM from 5/2010 to 12/2014, we would like to draw the following conclusions: Clinical and paraclinical characteristics before the surgery 24 Patients in working age, female/male = 1.7, rheumatic heart disease (68.9%) Received a surgery in late stage with clear clinical symptoms: breathing difficulty (96.7%), right heart failure (44.3%) NYHA II and III account for 100%, AF (65.6%), LA dilatation, PAPs: (45.8 ± 15.9 mmHg) TR at moderate-severe level (51.6%), left atrial thrombus (31.9%), stenosis-regurgitation combination (80.3%), typical images of MV lesions due to RF: adhesive thickening ( 95.9%), calcification (74.6%), shrinkage (69.7%), Willkins 8-10 points (86.5%) Results after the surgery of MV replacement with St.Jude valves The valve size of St.Jude 29 is mainly used (51.6%), the rate suitable for the area of skin is 100% and the preservation of posterior leaflet ligaments (88.5%) Fix TV using PTFE strip (76.0%) The average time of the aortic and CEC pair is not significantly longer than other authors, averaging 60.3 ± 26.5 minutes and 95.6 ± 32.1 minutes Heart rate beats naturally with SR (60.7%) Clinical and paraclinical symptoms are improved significantly after surgery: NYHA I (80.3%), stable hemodynamics (59%), SR (45.9%) echocardiographic indicators such as LA size, LV diameter, PAP, differential pressure across the valve are good and the difference with preoperative ultrasound results have meaning of p

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