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) has the highest mortality rate 19 Figure 4.1 Mortality rate according to STS score Moreover, two patients had hematologic diseases, one patient had cirrhosis at Child Pugh C stage Even though these patients did not have high surgical risk, the cardiac surgeons recommended against surgery due to coagulation dysfunction In reality, there were patients with even low risk according to the STS or EuroSCORE II scales, but surgical management was not appropriate This finding underscored the importance of a new classification of surgical risk that can help physicians selecting the suitable candidates for TAVI 4.2 Subclinical evaluation before TAVI Transthoracic echocardiogram (TTE) has been the routine evaluation for patients with AS However, echocardiogram could only provide the 2D imaging of the heart (unless 3D trans-esophageal echocardiogram was performed) Meanwhile, aortic valve is a 3D structure, with an elliptical shape ring, with long and short axes Therefore, TTE might yield inaccurate measurements MSCT scan of the aortic valve was required before TAVI, so that appropriate equipment could be determined A study among patients with AS undergoing SAVR showed that the mean diameter of the valve on MSCT was 24,0 ± 2,1mm, which was close to the diameter 20 measured during surgery (23,8 ± 0,2mm) In our study, the mean diameter of aortic valve was 24,2 ± 2,2mm, similar to other findings 4.2 Characteristics of the TAVI procedure in Vietnam 4.1.2 Success rate of the procedure The procedure was successfully performed on 47 out of 48 patients (97,9%) Hemodynamic assessments post-procedure showed significant improvements in trans-aortic gradient Our findings were consistent with those of other studies in the world For example, in the ADVANCE trial, 96% of patients achieved a trans-aortic gradient under 20 mmHg In the Asian-TAVR study, the success rate was 97,5% We concluded that TAVI was a procedure with high success rate 4.1.2 Characteristics of the procedure There were some changes in the protocol of TAVI at the heart centers in Vietnam between the period 2013-2016 and the period 20172019 First, hybrid operation rooms have been used recently, with less procedures done in the cathlab Second, following global trends, TAVI procedure has been simplified, with increasing use of the Seldinger method for obtaining vascular access, decreasing use of transesophageal echocardiography Predilatation of the aortic valve before TAVI has also become less common Performing transfemoral TAVI under local anaesthesia, using a fully percutaneous approach, and eliminating transoesophageal echocardiographic guidance (maintaining back-up transthoracic echocardiography) and balloon predilation are strategies to reduce the invasiveness and costs of the procedure 21 p < 0,01 Proportions (%) 100 100 90 80 70 60 50 40 30 20 10 p > 0,05 100 p < 0,05 91.3 p = 0,16 86.9 76 68 30.4 16 TAVI in cathlab Seldinger for Intra-procedural vascular access TEE 2013-2016 (23 patients) Balloon aortic predilatation 2017-2019 (25 patients) Figure 4.2 Changes in TAVI procedures over time 4.1.2 Sizes of biosynthesis valves We used 26mm and 29mm valves for most of our patients In the Asian-TAVR study, which analyzed data from TAVI cases in Asia from 2010 to 2014, the majority patients received 23mm and 26mm valves Therefore, our patients received larger valves Our study was conducted in a later period than the Asian-TAVR study, from 2013 to 2019, when there was a global trend of using larger artificial valves to optimize effective oriface area and to avoid para-valvular leaks 4.4 Complications of TAVI Among our 48 patients, one case failed due to left ventricular perforation when the equipment was inserted through the ventricular wall, leading to patient’s death Left ventricular perforation was a rare but severe complication of TAVI When perforation happened, the only way to save patients was to convert to an open heart surgery It was critical to have good collaborations with the cardiothoracic surgical 22 team, so that emergency managements of severe complications could be done successfully and the safety of the procedure could be guaranteed Apart from one patient who died during the procedure, more patients died after the surgery In-patient mortality rate was 8,3% All of these cases happened during the initial period of the study From 2013 to 2016, out of 23 patients died (17,4%), while no patient died during the period from 2017-2019 (0,0%) Similar to findings in other studies, the mortality rate in our study decreased over time In a study among 32.400 TAVI cases in Germany from 2008 to 2013, in-patient mortality rate decreased from 9,1% in 2008 to 5,6% in 2013 4.5 Longitudinal follow-up of patients 4.5.1 Survival rate One-year survival rate was 91,7%, similar to other trials such as PARTNER 2, Asian-TAVR and ADVANCE These studies showed that higher age, chronic kidney and lung diseases, peripheral vascular diseases and higher STS score were prognostic factors of mortality after TAVI However, in our study, except for an STS score of more than 8% and functional symptoms at NYHA III-IV, other clinical characteristics and history of patients did not predict post-procedure mortality 4.5.2 Clinical follow-up TAVI significantly improved clinical symptoms of patients The proportion of patients with NYHA III-IV decreased form 83,3% before the procedure to 18,0% after the procedure At the one-year follow-up visit, no patients had NYHA III-IV functional class These findings were comparable to other studies in the world 4.5.3 Echocardiographic follow-up TTE showed decreased trans-aortic gradients and increased aortic valve areas There were no differences in the assessments at 30 days and one year post-procedure Other studies in the world also found similar results Patients with EF 8% and NYHA class III-IV were two determinants of mortality after TAVI - TAVI improved hemodynamic features of aortic valve, with decrease in trans-aortic gradient and increase in AVA and EF Patients with low EF had the most benefit from the procedure 24 RECOMMENDATIONS TAVI can be performed in severe AS patients with high surgical risk or inoperable patients TAVI centers should be ready for management of severe complications such as left ventricle perforation Post-procedural care is extremely important to reduce in-hospital mortality 25 PUBLICATIONS Complications of trans-catheter aortic valve implantation in Vietnamese patients, Journal of Vietnamese Cardiology (2019) ISSN 1859-2848 Vol 89:14-22 [article in Vietnamese] Clinical outcomes of transcatheter aortic valve implantation among patients with aortic stenosis at several heart centers in Vietnam, Journal of Medical Research (2019), ISSN 2354080X Vol 122(6):1-9 [article in Vietnamese] ... suitable candidates for TAVI 4.2 Subclinical evaluation before TAVI Transthoracic echocardiogram (TTE) has been the routine evaluation for patients with AS However, echocardiogram could only provide... aortic valve is a 3D structure, with an elliptical shape ring, with long and short axes Therefore, TTE might yield inaccurate measurements MSCT scan of the aortic valve was required before TAVI,... Balloon aortic predilatation 2017-2019 (25 patients) Figure 4.2 Changes in TAVI procedures over time 4.1.2 Sizes of biosynthesis valves We used 26mm and 29mm valves for most of our patients In

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Mục lục

  • CONTRIBUTIONS OF THE STUDY

  • In Vietnam, it is the first time the safety and efficacy of TAVI were evaluated, especially among high surgical risk patients. The outcomes, as well as complications of TAVI in our study, are similar to other TAVI studies in the world, showing this pr...

  • The study has evaluated the role of echocardiography, multi-slice CT of aortic valve, invasive catheterization, in the diagnosis of aortic stenosis, and in screening suitable candidates for TAVI. These results can provide the foundation for standardiz...

  • STRUCTURE OF THE THESIS

  • BACKGROUND

    • 1.1. Etiology and pathophysiology of aortic stenosis

    • 1.2. Clincal and sub-clinical manifestations of AS patients

    • 1.3. Management of AS

      • 1.3.1. Medical management

      • 1.3.2. Balloon aortic valvuloplasty

      • 1.3.3. Surgical aortic valve replacement (SAVR)

      • 1.4. Transcatheter aortic valve implantation (TAVI)

      • CHAPTER 2

      • 2.1. Location and time of the research

      • 2.2. Research participants

      • 2.3. Research methods

        • 2.3.1. Study design

        • 2.3.2. Sample size and sampling methods

        • 2.3.3. Study procedures

        • Figure 2.1. Study protocol

        • 2.3.4. Data analysis

        • 2.5. Ethics

        • 3.1. Patients characteristics

          • 3.2.1. Procedural characteristics

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