Implante transcateter de valva aórtica para o tratamento da estenose aórtica grave: uma revisão sistemática de estudos de avaliação econômica completa / Transcatheter aortic valve implantation for the treatment of severe aortic stenosis: a systematic review of complete economic evaluation studies

Objetivo: Comparar o implante transcateter de valva aórtica (TAVI) ao tratamento conservador em pacientes inoperáveis ou à cirurgia de troca valvar (SAVR) em pacientes com risco cirúrgico alto ou intermediário conforme a Society of Thoracic Surgeons (STS), por meio de uma revisão sistemática de avaliações econômicas completas. Avaliar a variabilidade de modelos econômicos, parâmetros, pressupostos e sua influência nos resultados finais. Métodos: Foi realizada uma busca da literatura nas bases Medline, EMBASE, Cochrane Library, Web of Science, SciELO e International HTA Base e busca manual. Foram incluídas análises econômicas completas baseadas em modelos econômicos publicadas entre 2011 e 2022, em português, inglês e espanhol. A qualidade dos estudos foi avaliada usando o instrumento QHES (Quality of Health Economic Studies). Resultados: Foram incluídos 36 estudos, majoritariamente análises de custo-utilidade (64%), da Europa (41%), utilizando dados de eficácia dos estudos PARTNER. O modelo de Markov (61%) foi predominante. O custo da prótese do TAVI foi um parâmetro de impacto na análise de sensibilidade nos três grupos. Os estudos alcançaram uma boa qualidade no instrumento QHES. Conclusão: O TAVI tendeu a ser custo-efetivo em relação aos comparadores. Os modelos não foram homogêneos nos parâmetros, horizontes temporais e taxa de desconto, podendo impactar a custo-efetividade do TAVI e dificultar a comparação dos resultados entre diferentes países e perspectivas.

ABSTRACT Objective: To compare transcatheter aortic valve implantation (TAVI) to conservative treatment in inoperable patients or to valve replacement surgery (SAVR) in patients at high or intermediate surgical risk according to the Society of Thoracic Surgeons (STS), through a systematic review of comprehensive economic evaluations. Evaluate the variability of economic models, parameters, assumptions and their influence on final results. Methods: A literature search was performed in Medline, EMBASE, Cochrane Library, Web of Science, SciELO and International HTA Base and manual search. Complete economic analyzes based on economic models published between 2011 and 2022 in Portuguese, English and Spanish were included. The quality of the studies was evaluated using the QHES (Quality of Health Economic Studies) instrument. Results: Thirty-six studies were included, mostly cost-utility analyses (64%), from Europe (41%), and using efficacy data from the PARTNER studies. The Markov model (61%) was predominant. The cost of the TAVI prosthesis was the most important parameter in the sensitivity analysis in the three groups. The studies achieved a good quality in QHES instrument. Conclusion: TAVI tended to be cost-effective relative to comparators. The models were not homogeneous in parameters, time horizons and discount rate, which may have an impact on the cost-effectiveness of TAVI, making it difficult to compare the results between different countries and perspectives.

Cerebral ischemic injury after transcatheter aortic valve replacement in patients with pure aortic regurgitation / 浙江大学学报（英文版）（B辑：生物医学和生物技术）

Considering the surgical risk stratification for patients with severe calcific aortic stenosis (AS), transcatheter aortic valve replacement (TAVR) is a reliable alternative to surgical aortic valve replacement (SAVR) (Fan et al., 2020, 2021; Lee et al., 2021). Despite the favorable clinical benefits of TAVR, stroke remains a dreaded perioperative complication (Auffret et al., 2016; Kapadia et al., 2016; Kleiman et al., 2016; Huded et al., 2019). Ischemic overt stroke, identified in 1.4% to 4.3% of patients in TAVR clinical practice, has been associated with prolonged disability and increased mortality (Auffret et al., 2016; Kapadia et al., 2016; Levi et al., 2022). The prevalence of hyperintensity cerebral ischemic lesions detected by diffusion-weighted magnetic resonance imaging (DW-MRI) was reported to be about 80%, which is associated with impaired neurocognitive function and vascular dementia (Vermeer et al., 2003; Barber et al., 2008; Kahlert et al., 2010).

In Vitro Experimental Study on Hemodynamics of Transcatheter Aortic Valve Replacement / 中国医疗器械杂志

The patient-specific aortic silicone model was established based on CTA data. The digital particle image velocimetry (DPIV) test method in the modified ViVitro pulsatile flow system was used to investigate the aortic hemodynamic performance and flow field characteristics before and after transcatheter aortic valve replacement (TAVR). The results showed that the hemodynamic parameters were consistent with the clinical data, which verified the accuracy of the model. From the comparative study of preoperative and postoperative effective orifice area (0.33 cm2 and 1.78 cm2), mean pressure difference (58 mmHg and 9 mmHg), percentage of regurgitation (52% and 8%), peak flow velocity (4.60 m/s and 1.81 m/s) and flow field distribution (eccentric jet and uniform jet), the immediate efficacy after TAVR is good. From the perspective of viscous shear stress and Reynolds shear stress, the risk of hemolysis and thrombotic problems was low in preoperative and postoperative patient-specific models. This study provides a set of reliable DPIV testing methods for aortic flow field, and provides biomechanical basis for the immediate and long-term effectiveness of TAVR from the perspective of hemodynamics and flow field characteristics. It has important application value in clinical diagnosis, surgical treatment and long-term evaluation.

Prevalência de regurgitação paravalvar após implante transcateter de válvula aórtica / Prevalence of paravalve regurgitation after aortic valve transcatheter implantation

Introdução: Com o envelhecimento populacional brasileiro, esperase que a incidência de doenças cardiovasculares, como a estenose e insuficiência da válvula aórtica, eleve-se. Desde 2002, o implante valvar aórtico transcateter demonstrou-se método de alta eficácia no seu tratamento. No entanto, o procedimento está sujeito ao regurgitamento paravalvar. Objetivo: Avaliar quantitativamente a prevalência dessa regurgitação em pacientes submetidos ao Implante valvar aórtico transcateter. Métodos: Estudo observacional, transversal, retrospectivo que analisou 38 casos de Implante valvar aórtico transcateter. Os dados foram coletados dos prontuários, que incluíram informações antropométricas, comorbidades e procedimentos prévios à operação, e analisou-se a presença de refluxo paravalvar no 1° mês e 1° ano pós-Implante valvar aórtico transcateter. Resultados: A idade média foi de 74 ±11,2 anos; 15 pacientes dos analisados, possuíam classificação NYHA igual a III, e 1 NYHA IV, previamente à operação. Do total, 36,32% (n=8) tinham refluxo paravalvar no 1° mês e 1º. ano após o procedimento cirúrgico. Conclusão: A prevalência de refluxo paravalvar pós-operatório em pacientes submetidos ao Implante valvar aórtico transcateter, foi igual a 36,3% tanto para a avaliação realizada no 1° mês quanto no 1° ano.

Introduction: With the aging of the Brazilian population, it is expected that the incidence of cardiovascular diseases, such as stenosis and insufficiency of the aortic valve, will increase. Since 2002, transcatheter aortic valve implantation has proved to be a highly effective method of treatment. However, the procedure is subject to paravalvular regurgitation. Objective: To quantitatively assess the prevalence of paravalvular regurgitation in patients undergoing Transcatheter aortic valve implantation. Methods: Observational, cross-sectional, retrospective study that analyzed 38 Transcatheter aortic valve implantation cases. Data were collected from medical records, which included anthropometric information, comorbidities and procedures prior to the operation, and the presence of paravalvular regurgitation in the 1st month and 1st year after Transcatheter aortic valve implantation was analyzed. Results: Mean age was 74 ±11.2 years; 15 of the analyzed patients had NYHA classification equal to III, and 1 NYHA IV, prior to the operation. Of the total, 36.32% (n=8) of the patients had paravalvular regurgitation in the 1st and 1st month. year after the surgical procedure. Conclusion: The prevalence of postoperative paravalvular regurgitation in patients undergoing Transcatheter aortic valve implantation was equal to 36.3% both for the assessment carried out in the 1st month and in the 1st year

Abordaje transcaval en reemplazo valvular aórtico percutáneo: primer caso en Costa Rica / Transcaval approach in valve replacement Percutaneous Aortic Surgery: First Case in Costa Rica

La estenosis aórtica severa sintomática que se presenta en pacientes de alto o mediano riesgo quirúrgico puede ser abordada de manera percutánea con reemplazos valvulares aórticos transcateter. Existe sólida evidencia de resultados favorables en estos pacientes con un perfil de seguridad adecuado. El abordaje transfemoral es el más utilizado y ha demostrado ser más seguro en comparación a los abordajes torácicos. Sin embargo, desde mitades de la década pasada el abordaje transcaval se ha convertido en una opción en los pacientes que presentan un riesgo quirúrgico alto y que presentan una vasculatura inadecuada para un abordaje transfemoral seguro. Presentamos el caso de un paciente de 65 años en quien se empleó este abordaje dado a su alto riesgo quirúrgico e inaccesibilidad para realizar un abordaje transfemoral.

Severe symptomatic aortic stenosis in patients with high surgical risk can be addressed percutaneously with transcatheter aortic valve replacement (TAVR). There is solid evidence of favorable results with an adequate safety profile in these patients. The transfemoral approach is the most widely used and has shown to be safer compared to thoracic approaches. Though, since the middle of the last decade, the transcaval approach has become an option in patients who present a high surgical risk and who have inadequate vasculature for a safe transfemoral approach. We present the case of a 65-year-old patient in whom this approach was preferred due to his high surgical risk and inaccessibility to perform a transfemoral approach.

Resultados del implante percutáneo de válvula aórtica (TAVI). Experiencia después de la primera década desde la introducción de la técnica / Transcatheter aortic-valve implantation. A ten years clinical experience

BACKGROUND: Transcatheter aortic-valve implantation (TAVI) was introduced in 2002 and the first implants in our country were performed in 2010. AIM: To review the TAVI experience in our hospital, considering the technology improvements and gained experience throughout this period. MATERIAL AND METHODS: All patients undergoing TAVI in our center were included. Results and complications were adjudicated according to the Valve Academic Research Consortium-2 (VARC-2) criteria. Patients were divided in 3 groups, according to procedural year: Period 1: 2010-2015 (n = 35); Period 2: 2016-2018 (n = 35); Period 3: 2019-2021 (n = 41). Mortality up to one year after the procedure was recorded. RESULTS: Between 2010 and 2021, 111 TAVI procedures were performed. The mean age of patients was 82 years and 47% were women. Risk scores for in-hospital mortality were STS 6.7%, EUROSCORE II 8.0% and ACC/STS TAVR Score 4.9%. The trans-femoral route was used in 88% and a balloon-expandable valve was chosen in 82% of patients. A successful implant was achieved in 96%, with an in-hospital mortality of 1.8%. Mortality at 30 days and 1-year were 2.7 and 9.0%, respectively. During period 3, 100% of implants were successful, with no in-hospital mortality, less vascular complications (p < 0.01), less stroke (p = 0.04), less severe paravalvular leak (p = 0.01) and significantly lower rate of acute complications (p < 0.01). CONCLUSIONS: TAVI achieves excellent results. With greater experience and better available technologies, these results are even more favorable.

Comparison of anesthesia management in transcatheter aortic valve implantation: a retrospective cohort study

Abstract Background and objectives We aimed to investigate the effects of two different anesthetic techniques in our patients who underwent transcatheter aortic valve implantation (TAVI). Methods In this study, 303 patients who underwent TAVI procedure with a diagnosis of severe aortic stenosis between January 1, 2012 and December 31, 2018 were retrospectively evaluated. The patients were divided according to the type of anesthesia given during each procedure as; general anesthesia (GA), local anesthesia (LA). Results LA was preferred in 245 (80.8%) of 303 patients who underwent TAVI, while GA was preferred in 58 patients (19.1%). Median ages ​​of our patients who received LA and GA were 83 and 84, respectively. The procedure and anesthesia durations of the patients in the GA group were longer than the LA group (p< 0.00001, p< 0.00001, respectively). Demographic and pre-operative clinical data were similar in comparison between two groups (p> 0.05) except for peripheral artery disease. Hypertension was the most common comorbidity in both groups. While the number of inotrope use was significantly higher in patients who received GA (p< 0.00001), no significant differences were found between LA and GA patients in terms of major complications and mortality (p> 0.05). Intensive care and hospital stays were significantly shorter in the LA group (p= 0.001, p= 0.023, respectively). Conclusion The anesthetic technique of TAVI procedure did not have a significant effect on outcomes including; complications, mortality and success of the procedure. LA provides shorter duration of procedure and hospital stay.

Abordaje del implante valvular aórtico transcateter durante la pandemia por COVID-19 con alta prevoz: reporte de una serie de casos / Transcatheter aortic valve implantation (TAVI) with conscious sedation and early discharge: report of seven cases

COVID-19 pandemic generated multiple challenges for the health system. Cardiovascular disease is associated with a worse prognosis of infections. Moreover, most hospital resources and operative rooms were destined to patients with COVID-19 infection, deferring the treatment of most valvular patients requiring surgery. We report seven patients with symptomatic severe aortic stenosis who underwent transcatheter aortic valve implantation (TAVI) with conscious sedation and early discharge. No patient required intensive care unit admission or mechanical ventilation. After a 90-day follow-up, there were no complications or unplanned readmissions.

Impact of bicuspid aortic valve or tricuspid aortic valve on hemodynamics and left ventricular reverse remodeling in patients after transcatheter aortic valve replacement / 中华心血管病杂志

Objective: To compare the impact of bicuspid aortic valve (BAV) or tricuspid aortic valve (TAV) on hemodynamics and left ventricular reverse remodeling after transcatheter aortic valve replacement (TAVR). Methods: We retrospectively analyzed the clinical data of patients who underwent TAVR in our hospital from January 2019 to March 2021. Patients were divided into BAV group and TAV group according to aortic contrast-enhanced CT. Each patient was followed up by N-terminal pro B-type natriuretic peptide (NT-proBNP) and echocardiography at four time points, namely before TAVR, 24 hours, 1 month and 6 months after TAVR. Echocardiographic data, including mean pressure gradient (MPG), aortic valve area (AVA), left ventricular ejection fraction (LVEF), left ventricle mass (LVM) and LV mass index (LVMi) were evaluated. Results: A total of 41 patients were included. The age was (75.0±8.6) years, and male patients accounted for 53.7%. There were 19 BAV patients and 22 TAV patients in this cohort. All patients undergoing TAVR using a self-expandable prosthesis Venus-A valve. MPG was (54.16±21.22) mmHg(1 mmHg=0.133 kPa) before TAVR, (21.11±9.04) mmHg at 24 hours after TAVR, (18.84±7.37) mmHg at 1 month after TAVR, (17.68±6.04) mmHg at 6 months after TAVR in BAV group. LVEF was (50.42±13.30)% before TAVR, (53.84±10.59)% at 24 hours after TAVR, (55.68±8.71)% at 1 month after TAVR and (57.42±7.78)% at 6 months after TAVR in BAV group. MPG and LVEF substantially improved at each time point after operation, and the difference was statistically significant (all P<0.05) in BAV group. MPG in TAV group improved at each time point after operation, and the difference was statistically significant (all P<0.05). LVMi was (164.13±49.53), (156.37±39.11), (146.65±38.84) and (134.13±39.83) g/m2 at the 4 time points and the value was significantly reduced at 1 and 6 months post TAVR compared to preoperative level(both P<0.05). LVEF in the TAV group remained unchanged at 24 hours after operation, but it was improved at 1 month and 6 months after operation, and the difference was statistically significant (all P<0.05). LVMi in TAV group substantially improved at each time point after operation, and the difference was statistically significant (all P<0.05). NT-proBNP in both two groups improved after operation, at 1 month and 6 months after operation, and the difference was statistically significant (all P<0.05). MPG in TAV group improved better than in BAV group during the postoperative follow-up (24 hours after TAVR: (11.68±5.09) mmHg vs. (21.11±9.04) mmHg, P<0.001, 1 month after TAVR: (10.82±3.71) mmHg vs. (18.84±7.37) mmHg, P<0.001, 6 months after TAVR: (12.36±4.42) mmHg vs. (17.68±6.04) mmHg, P=0.003). There was no significant difference in NT-proBNP between BAV group and TAV group at each time point after operation (all P>0.05). There was no significant difference in paravalvular regurgitation and second prosthesis implantation between the two groups (all P>0.05). Conclusions: AS patients with BAV or TAV experience hemodynamic improvement and obvious left ventricular reverse remodeling after TAVR, and the therapeutic effects of TAVR are similar between BAV and TAV AS patients in the short-term post TAVR.

Cenário Disfuncional dos Principais Componentes Responsáveis pelo Equilíbrio do Trânsito de Cálcio Miocárdico na Insuficiência Cardíaca Induzida por Estenose Aórtica / The Dysfunctional Scenario of the Major Components Responsible for Myocardial Calcium Balance in Heart Failure Induced by Aortic Stenosis

Resumo Fundamento O remodelamento cardíaco patológico se caracteriza por disfunção diastólica e sistólica, levando à insuficiência cardíaca. Neste contexto, o cenário disfuncional do trânsito de cálcio miocárdico (Ca2+) tem sido pouco estudado. Um modelo experimental de estenose aórtica tem sido extensamente utilizado para aprimorar os conhecimentos sobre os principais mecanismos do remodelamento patológico cardíaco. Objetivo Entender o processo disfuncional dos principais componentes responsáveis pelo equilíbrio do cálcio miocárdico e sua influência sobre a função cardíaca na insuficiência cardíaca induzida pela estenose aórtica. Métodos Ratos Wistar de 21 dias de idade foram distribuídos em dois grupos: controle (placebo; n=28) e estenose aórtica (EaO; n=18). A função cardíaca foi analisada com o ecocardiograma, músculo papilar isolado e cardiomiócitos isolados. No ensaio do músculo papilar, SERCA2a e a atividade do canal de Ca2+ do tipo L foram avaliados. O ensaio de cardiomiócitos isolados avaliou o trânsito de cálcio. A expressão proteica da proteínas do trânsito de cálcio foi analisada com o western blot. Os resultados foram estatisticamente significativos quando p <0,05. Resultados Os músculos papilares e cardiomiócitos dos corações no grupo EaO demonstraram falhas mecânicas. Os ratos com EaO apresentaram menor tempo de pico do Ca2+, menor sensibilidade das miofibrilas do Ca2+, prejuízos nos processos de entrada e recaptura de cálcio pelo retículo sarcoplasmático, bem como disfunção no canal de cálcio do tipo L (CCTL). Além disso, os animais com EaO apresentaram maior expressão de SERCA2a, CCTL e trocador de Na+/Ca2+. Conclusão Insuficiência cardíaca sistólica e diastólica devido à estenose aórtica supravalvular acarretou comprometimento da entrada de Ca2+ celular e inibição da recaptura de cálcio pelo retículo sarcoplasmático devido à disfunção no CCTL e SERCA2a, assim como mudanças no trânsito de cálcio e na expressão das principais proteínas responsáveis pela homeostase de Ca2+ celular.

Abstract Background Maladaptive cardiac remodelling is characterized by diastolic and systolic dysfunction, culminating in heart failure. In this context, the dysfunctional scenario of cardiac calcium (Ca2+) handling has been poorly studied. An experimental model of aortic stenosis has been extensively used to improve knowledge about the key mechanisms of cardiac pathologic remodelling. Objective To understand the dysfunctional process of the major components responsible for Ca2+ balance and its influence on cardiac function in heart failure induced by aortic stenosis. Methods Male 21-day-old Wistar rats were distributed into two groups: control (sham; n= 28) and aortic stenosis (AoS; n= 18). Cardiac function was analysed by echocardiogram, isolated papillary muscle, and isolated cardiomyocytes. In the papillary muscle assay, SERCA2a and L-type Ca2+ channel activity was evaluated. The isolated cardiomyocyte assay evaluated Ca2+ handling. Ca2+ handling protein expression was analysed by western blot. Statistical significance was set at p <0.05. Results Papillary muscles and cardiomyocytes from AoS hearts displayed mechanical malfunction. AoS rats presented a slower time to the Ca2+ peak, reduced Ca2+ myofilament sensitivity, impaired sarcoplasmic reticulum Ca2+ influx and reuptake ability, and SERCA2a and L-type calcium channel (LTCC) dysfunction. Moreover, AoS animals presented increased expression of SERCA2a, LTCCs, and the Na+/Ca2+ exchanger. Conclusion Systolic and diastolic heart failure due to supravalvular aortic stenosis was paralleled by impairment of cellular Ca2+ influx and inhibition of sarcoplasmic reticulum Ca2+ reuptake due to LTCC and SERCA2a dysfunction, as well as changes in Ca2+ handling and expression of the major proteins responsible for cellular Ca2+ homeostasis.

Preliminary clinical experience of the novel transcatheter aortic valve system Prizvalve® for the treatment of severe aortic stenosis / 中华心血管病杂志

Objective: To evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) with the novel Prizvalve® system in treating severe aortic stenosis. Methods: This is a single-center, prospective, single-arm, observational study. A total of 11 patients with severe aortic stenosis with high risk or inappropriate for conventional surgical aortic valve replacement (SAVR) were included, and TAVI was achieved with the Prizvalve® system between March 2021 and May 2021 in West China Hospital. Transthoracic echocardiography (TTE) was performed immediately after prosthesis implantation to evaluate mean transaortic gradient and maximal transaortic velocity. The device success rate was calculated, which was defined as (1) the device being delivered via the access, deployed, implanted and withdrawn, (2) mean transaortic gradient<20 mmHg (1 mmHg=0.133 kPa) or a maximal transaortic velocity<3 m/s post TAVI, and without severe aortic regurgitation or paravalvular leak post TAVI. TTE was performed at 30 days after the surgery, and all-cause mortality as well as the major cardiovascular adverse events (including acute myocardial infarction, disabling hemorrhagic or ischemic stroke) up to 30 days post TAVI were analyzed. Results: The age of 11 included patients were (78.1±6.3) years, with 8 males. A total of 10 patients were with NYHA functional class Ⅲ or Ⅳ. Devices were delivered via the access, deployed, implanted and withdrawn successfully in all patients. Post-implant mean transaortic gradient was (7.55±4.08) mmHg and maximal transaortic velocity was (1.78±0.44) m/s, and both decreased significantly as compared to baseline levels (both P<0.05). No severe aortic regurgitation or paravalvular leak was observed post TAVI. Device success was achieved in all the 11 patients. No patient died or experienced major cardiovascular adverse events up to 30 days post TAVI. Mean transaortic gradient was (9.45±5.07) mmHg and maximal transaortic velocity was (2.05±0.42) m/s at 30 days post TAVI, which were similar as the values measured immediately post TAVI (both P>0.05). Conclusions: TAVI with the Prizvalve® system is a feasible and relatively safe procedure for patients with severe aortic stenosis and at high risk or inappropriate for SAVR. Further clinical studies could be launched to obtain more clinical experience with Prizvalve® system.

One-year follow-up results of atrial fibrillation patients who undergoing transcatheter aortic valve implantation / 中华心血管病杂志

Objective: To investigate whether atrial fibrillation (AF) before transcatheter aortic valve implantation (TAVI) will affect the prognosis of patients post TAVI. Methods: This is a single center retrospective study. A total of 115 patients with severe aortic stenosis (AS) who were admitted to General Hospital of Northern Theater Command from May 2016 to November 2020 and successfully received TAVI treatment were included. According to absence or accompaniment of AF pre-TAVI, they were divided into AF group (21 cases) and non-AF group (94 cases). The patients were followed up for postoperative antithrombotic treatment and the occurrence of the net adverse clinical and cerebrovascular events (NACCE) at 12 months post TAVI, including cardiogenic death, readmission to hospital for heart failure, nonfatal myocardial infarction, ischemic stroke and severe bleeding (BARC levels 3-5). Univariate logistic regression was used to analyze the related factors of NACCE. Results: Among the 115 selected patients, age was (73.8±6.9) years, there were 63 males. And 21 cases (18.2%) were diagnosed as AFbefore TAVI. In terms of postoperative antithrombotic therapy, 48.9% (46/94) of the patients in the non-AF group received monotherapy and 47.9% (45/94) received dual antiplatelet therapy. In the AF group, 47.6% (10/21) received anticoagulants and 33.3% (7/21) received dual antiplatelet therapy. The proportion of patients in the AF group taking non-vitamin K antagonist oral anticoagulants (NOAC) was higher than that in the non-AF group (38.1% (8/21) vs. 2.1% (2/94), P<0.001). Patients in both groups were followed up to 12 months after TAVI. During the 12 months follow-up, the incidence of NACCE after TAVI was 14.3% (3/21) in the AF group, which was numerically higher than that in the non-AF group (6.4% (6/94)), but the difference was not statistically significant (P=0.441). The incidence of severe bleeding was significantly higher in the AF group than in the non-AF group (9.5% (2/21) vs. 0, P=0.032). Univariate logistic regression analysis showed that hypertension was associated with the risk of NACCE (OR=8.308, P=0.050), while AF was not associated with the risk of NACCE (P=0.235). Conclusion: The incidence of severe bleeding after TAVI is higher in patients with AF than in patients without AF prior TAVI, and there is a trend of increased risk of NACCE post TAVI in AF patients.

Preliminary evaluation on the efficacy of emergency transcatheter aortic valve replacement: a multicenter study / 中华心血管病杂志

Objectives: To explore the efficacy and safety of emergency transcatheter aortic valve replacement (TAVR). Methods: Data of patients who underwent emergency TAVR in eight centers, namely Fuwai Hospital, Wuhan Asia Heart Hospital, Xijing Hospital, Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Guangdong Provincial People's Hospital, Zhongshan Hospital Affiliated to Fudan University, the First Affiliated Hospital of Zhengzhou University, the Second Xiangya Hospital of Central South University, between May 2017 and December 2020 were retrospectively analyzed. The use of mechanical circulatory support system (MCS) and the results of laboratory tests (N-terminal B-type natriuretic peptide (NT-proBNP)) and echocardiography (mean aortic valve cross valve pressure difference and left ventricular ejection fraction) before and after operation were collected. The primary endpoint was all-cause death, and the secondary endpoints were stroke, major bleeding, major vascular complications, myocardial infarction, permanent pacemaker implantation, and acute renal injury. Device success was caculated, which refered to absence of procedural mortality and correct positioning of a single prosthetic heart valve into the proper anatomical location and intended performance of the prosthetic heart valve (mean aortic valve gradient<20 mmHg(1 mmHg=0.133 kPa) or peak velocity<3 m/s, with no moderate or severe prosthetic valve regurgitation). Kaplan-Meier survival curve was used to estimate the survival rate of patients during follow-up. Results: This study included 48 patients. The age was (72.5±8.1) years, and 34 patients were males (70.8%). Device success rate was 91.7% (44/48). The mean aortic valve transvalvular pressure was significantly decreased after operation ((12.3±6.4)mmHg vs. (60.2±23.8)mmHg, P<0.000 1). Left ventricular ejection fraction was significantly increased ((41.5±11.7)% vs. (31.0±11.3)%, P<0.000 1). NT-proBNP significantly decreased (3 492.0 (1 638.8, 7 165.5) ng/L vs. 12 418.5 (6 693.8, 35 000.0) ng/L, P<0.000 1). In-hospital all-cause mortality was 8.3% (4/48). During hospitalization, the rate of stroke was 2.1% (1/48), major bleeding was 6.3% (3/48), major vascular complications was 10.4% (5/48), myocardial infarction was 4.2% (2/48), permanent pacemaker implantation was 6.3% (3/48), and the rate of acute renal injury was 12.5% (6/48). MCS was used in 20 patients (41.7%). The median follow-up time was 196 days. During the follow-up, one patient died (due to systemic metastasis of pancreatic cancer), two cases suffered new myocardial infarction and one case received permanent pacemaker implantation. The survival rate of 30 days, 1 year and 2 years after the operation were 91.7% (44/48), 89.6% (43/48), 89.6% (43/48), respectively. Conclusion: Emergency TAVR may be a safe and effective treatment for patients with severe decompensated aortic valve stenosis.

Single center experience of transcatheter aortic valve replacement with a simplified operative protocol / 中华心血管病杂志

Objective: To summarize the single center experience of transcatheter aortic valve replacement (TAVR) with a simplified operative protocol. Methods: Consecutive patients who underwent transfemoral TAVR (TF-TAVR) from July 2020 to December 2020 in Fuwai Hospital were retrospectively analyzed. We compared the baseline characteristic, procedure information, 30-day follow-up outcomes of the patients who underwent TF-TAVR without the simplified operative protocol (routine group) or with the simplified operative protocol (simplified protocol group). Results: 93 patients were collected, 42 patients belonging to routine group, 51 patients belonging to simplified protocol group. In simplified protocol group, there were 51 patients planned to use ultrasound-guided femoral access puncture, procedure was successful in all 51 patients (100%). There were 49 patients planned to use the radial artery as the secondary access, procedure was successful in 45 patients (92%). There were 48 patients planned to use the strategy of avoidance of urinary catheter, this strategy was achieved in 35 patients (73%). There were 12 patients planned to use the left ventricular guidewire to pace, procedure was successful in 11 patients (92%). There were no differences in baseline characteristics, major clinical endpoints and 30-day follow-up outcomes between the two groups. Meanwhile, the procedure time ((62.5±17.9)min vs. (78.3±16.7)min, P<0.001), operation room time ((133.7±25.1)min vs. (159.2±42.6)min, P<0.001), X-ray exposure time ((17.2±6.5)min vs. (20.2±7.7)min, P=0.027) were significantly shorten in simplified protocol group compared with the routine group. Conclusion: Our study results indicate that the simplified operative protocol of TF-TAVR is as effective and safe as the routine operative protocol, meanwhile using the simplified operative protocol can significantly increase the operative efficiency of TF-TAVR.

Clinical characteristics of severe aortic stenosis patients combined with diabetes mellitus after transcatheter aortic valve replacement and short-term outcome / 中南大学学报(医学版)

OBJECTIVES@#Type 2 diabetes (T2DM) is a common comorbidity in patients with degenerative aortic stenosis (AS).As a key item of the American Society of Thoracic Surgeons (STS) score, it has a vital impact on the clinical prognosis of traditional thoracic surgery. T2DM has an adverse effect on the morbidity and mortality of cardiovascular diseases. At the same time, studies have shown that T2DM are associated with myocardial hypertrophy and remodeling, decreased left ventricular function, and worsening heart failure symptoms in the AS patients. Transcatheter aortic valve replacement (TAVR) as an interventional method to replace the aortic valve has better safety for middle and high risk patients in surgery, but the impact of T2DM on the clinical outcome of TAVR in AS patients is not clear.By analyzing the clinical and image characteristics of patients with AS and T2DM who received TAVR treatment, so as to explore the effect of T2DM on the perioperative complications and prognosis of TAVR.@*METHODS@#A total of 100 consecutive patients with severe AS, who underwent TAVR treatment and were followed up for more than 1 month, were selectedin the Second Xiangya Hospital of Central South University from January 2016 to December 2020.Among them, 5 patients who were treated with TAVR due to simple severe aortic regurgitation were not included, therefore a total of 95 patients with severe aortic stenosis were enrolled in this study.The age of the patients was (72.7±4.8) years old, and there were 58 males (61.1%), and the patients with moderate or above aortic regurgitation had 30 cases (31.6%). The patients were divided into a diabetic group and a non-diabetic group according to whether they were combined with T2DM.There was no statistical difference in age, gender, body mass index (BMI), STS score, and New York Heart Association (NYHA) cardiac function classification between the 2 groups (all P>0.05). The primary end point was defined as a composite event consisting of all-cause death and stroke one month after surgery, and the secondary end point was defined as TAVR-related complications immediately after surgery and one month after surgery.The preoperative clinical data, cardiac ultrasound data, CT data, postoperative medication and the incidence of each endpoint event were compared between the 2 groups.The predictive model of adverse events was constructed by single factor and multivariate logistic regression.@*RESULTS@#Compared with the non-diabetic group, the diabetic group had high blood pressure and chronic renal insufficiency.There was no significant difference in preoperative ultrasound echocardiography between the 2 groups. Preoperative CT evaluation found that the anatomical structure of the aortic root in the diabetic group was smaller than that in the non-diabetic group, and there was no significant difference in the incidence of bicuspid aortic valve between the 2 groups (all P<0.05). In terms of postoperative medication, the use of statins in the diabetes group was significantly higher than that in the non-diabetic group. In the diabetes group, 6 patients (37.5%) received insulin therapy, and 9 patients (56.3%) received oral medication alone.Univariate logistic regression analysis showed that the all-cause death and stroke compound events was increased in the diabetes group in 30 days after TAVR (OR=6.86; 95% CI: 2.14 to 21.79; P<0.01). Heart disease (OR=2.80; 95% CI: 0.99 to 7.88; P<0.05) and chronic renal insufficiency (OR=3.75; 95% CI: 1.24 to 11.34; P<0.05) were also risk factors for all-cause death and stroke compound events.In a multivariate analysis, after adjusting for age, gender, BMI, comorbidities, N-terminal pro-B type natriuretic peptide (NT-proBNP), total calcification score, ejection fraction, and degree of aortic regurgitation, T2DM was still a risk factor for all-cause death and stroke compound events in 30 days after TAVR (OR=12.68; 95% CI: 1.76 to 91.41; P<0.05).@*CONCLUSIONS@#T2DM is a risk factor for short-term poor prognosis in patients with symptomatic severe AS after TAVR treatment. T2DM should play an important role in the future construction of the TAVR surgical risk assessment system, but the conclusions still need to be further verified by long-term follow-up of large-scale clinical studies.

Glasgow prognostic score as a marker of mortality after TAVI

Abstract Introduction: The Glasgow prognostic score (GPS) reflects host systemic inflammatory response and has been reported to be significant as a prognostic indicator in cancer-bearing patients. The aim of this study was to evaluate the predictive value of GPS in outcomes of patients with severe aortic stenosis who were treated with transcatheter aortic valve implantation (TAVI). Methods: The study population consisted of 79 patients who underwent TAVI due to severe aortic stenosis between January 2018 and March 2019 in our clinic. Echocardiographic and laboratory data were recorded before the procedure and GPS was scored as 0, 1, or 2, based on serum albumin and C-reactive protein levels. European System for Cardiac Operative Risk Evaluation II scoring system was used for risk stratification. The primary endpoints of the study were postoperative in-hospital mortality, hospitalization due to cardiac causes, or mortality within a year. Results: The 79 patients were classified into two groups according to outcomes. Fifteen patients (19%) reached the primary endpoints at one year of follow-up. Compared to the patients who did not reach the endpoints, these 15 patients were not different in terms of age, preoperative mean gradient, and ejection fraction (P>0.05 for all). GPS was the only laboratory parameter with statistically significant difference between the groups (P=0.008) and multivariate analysis showed that GPS was independent predictor of primary endpoints (P=0.012, odds ratio 4.51, 95% confidence interval 1.39-14.60). Conclusion: GPS is an easy, noninvasive laboratory test which may be used as a predictive biomarker for outcomes in patients undergoing TAVI.