Implante de válvula aórtica percutánea por acceso transcarotídeo: reporte del primer caso realizado en Chile / Percutaneous aortic valve replacement by trans-carotid approach: First case in Chile

La indicación en el implante de la válvula aortica percutánea (TAVI) se ha incrementado considerablemente en los últimos años, utilizando de preferencia el acceso transfemoral (TF), sin embargo, no queda claro cual debería ser la 2 vía de preferencia ante contraindicaciones a esta última. Presentamos un paciente de 81 años con alto riesgo quirúrgico en quien luego de discusión con heart team se decidió realizar TAVI y posterior a la identificación de obstrucción de la luz aortica descendente de 50%, se decidido realizar acceso transcarotideo izquierdo. Numerosos abordajes alternativos a la vía TF han sido descriptos en los últimos años. La vía transcarotidea ha sido la de mejores resultados en distintas revisiones clínicas y la que se ha presentado como 2° alternativa a la TF en algoritmos establecidos. Reportamos el primer implante de TAVI por vía transcarotidea en el hospital las Higueras, Chile.

The indication for percutaneous aortic valve implantation (TAVI) has increased considerably in recent years, preferably using transfemoral access (TF); however, it is not clear which should be the preferred access in the event of contraindications to the latter. We present an 81-year-old patient with high surgical risk in whom a 50% obstruction of the descending aortic lumen was identified and so, a left transcarotid access was chosen. Numerous alternative approaches to the TF approach have been described in recent years. The transcarotid approach has been the one with the best results in different clinical reviews and the one that has been presented as the second alternative to TF in established algorithms. We report the first transcarotid TAVI implantation in Las Higueras Hospital, Talcahuano, Chile.

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.

Características y predictores ecocardiográficos de mortalidad en pacientes intervenidos con TAVI. La importancia de anticiparse al daño cardíaco global / Predictors of late mortality after TAVI: the relevance of early intervention to prevent global deterioration of cardiac function

Introducción: En nuestro medio, el implante percutáneo de prótesis aórtica (TAVI) se encuentra limitado a pacientes más añosos o de mayor riesgo quirúrgico, en quienes frecuentemente se retarda la intervención hasta que presenten signos avanzados de enfermedad. Objetivo: Evaluar el grado de compromiso miocárdico en pacientes sometidos a TAVI y determinar si la magnitud de este compromiso predice los resultados alejados del procedimiento. Métodos: Registro de pacientes sometidos a TAVI en 2 instituciones de Chile. Según la clasificación propuesta por Genereux el año 2017, se clasificaron desde el punto de vista ecocardiográfico como: 1) compromiso de ventrículo izquierdo; 2) compromiso de aurícula izquierda; 3) hipertensión pulmonar / insuficiencia tricuspídea significativa y 4) disfunción de ventrículo derecho. Resultados: Se incluyeron 209 pacientes. Se logró un procedimiento exitoso en 98,6%, registrándose una mortalidad intrahospitalaria de 2,9%. El compromiso cardíaco se extendió más allá de las cavidades izquierdas en 24,7% de los casos (estadíos 3 y 4). A una mediana de seguimiento de 650 días se registró una mortalidad de 26,8%. El compromiso de cavidades derechas (estadíos 3 y 4) se asoció a una mayor mortalidad (39,6% vs 22,1%, log rank p=0,015). En análisis multivariado, este compromiso fue el único factor que de forma independiente predijo mortalidad (HR 1,87, IC 1,01-3,44, p=0,044). Conclusiones: El compromiso de cavidades derechas se asocia a una mayor mortalidad alejada en pacientes sometidos a TAVI. Estos resultados debiesen estimular una derivación precoz de estos pacientes que, aunque añosos y de alto riesgo, tienen buenos resultados intervenidos precozmente.

Background: Locally, Transcatheter Aortic Valve Implantation (TAVI) is limited to very old or high-risk patients, whose intervention is frequently delayed until they develop signs of advanced disease. Aim: To evaluate the degree of myocardial compromise in patients undergoing TAVI and to determine whether the level of this compromise can predict results during follow-up. Methods: Registry of TAVI patients from 2 institutions in Chile. According to the classification proposed by Genereux in 2017, patients were classified based on the echocardiogram as 1) left ventricular compromise; 2) left atrial compromise; 3) pulmonary hypertension / severe tricuspid regurgitation; 4) right ventricular dysfunction. Results: The study included 209 patients. A successful procedure was achieved in 98.6% of cases, with an in-hospital mortality of 2.9%. Cardiac compromise extended beyond left chambers in 24.7% of cases (stages 3 and 4). During follow-up (median of 650 days) mortality was 26.8%. Right chambers involvement (stages 3 and 4) was associated with increased mortality (39.6% vs 22.1%, log rank p=0.015). In multivariate analysis, this compromise was the only factor that independently predicted mortality (HR 1.87, IC 1.01-3.44, p=0,044). Conclusions: Right chambers involvement was associated to increased mortality during follow-up of patients undergoing TAVI. These results should stimulate earlier referral of these high risk and older patients in order to obtain better results following the intervention.

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.

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).

Safety and efficacy of transcatheter aortic valve replacement using the "All in One" single artery/vessel technique / 中华心血管病杂志

Objective: To explore the safety and efficacy of transcatheter aortic valve replacement (TAVR) using the "All in One" single-artery/vessel technique. Methods: This is a retrospective study. A total of 30 consecutive patients underwent TAVR using the single artery/vascular technique in Beijing Anzhen Hospital from August to December 2021 were included. Baseline clinical data, operative situation, postoperative outcomes, and incidence of adverse events during hospitalization and at one month post TAVR were analyzed. Results: Mean age was (72.6±9.7) years, 16 were male patients, STS score was (4.73±3.12)%. Four patients were diagnosed as isolated aortic regurgitation (all with tricuspid aortic valves), and 26 patients were diagnosed as aortic stenosis (AS), 10 of whom with tricuspid aortic valves and 16 of whom with bicuspid aortic valves. The single-vessel technique was applied in 3 aortic stenosis cases; the single-artery technique was applied in 27 cases. Echocardiography was performed immediately after procedure and results showed no or trace perivalvular leak in 27 cases and small perivalvular leak in 3 cases; the mean aortic transvalvular gradient of 26 AS patients decreased from (50.4±16.0) mmHg (1 mmHg=0.133 kPa) to (9.4±3.2) mmHg (P<0.001). The procedure time was (64.8±18.9) min. There were no intraoperative death, valve displacement, conversion to surgery, coronary artery occlusion in all 30 patients. There were no major cardiac adverse events such as myocardial infarction or stroke occurred during hospitalization or at follow-up. One-month follow-up echocardiography indicated prosthesis works well. The symptoms were significantly alleviated, and the Kansas City Cardiomyopathy Score (KCCQ score) of all patients increased from 48.1±18.4 to 73.5±17.6 (P<0.001). Conclusions: TAVR using the single artery/vessel technique is safe and feasible. This technique is related to reduced access complications and worthy of wide application.

Safety and efficacy of transcatheter aortic valve replacement using the "All in One" single artery/vessel technique / 中华心血管病杂志

Objective: To explore the safety and efficacy of transcatheter aortic valve replacement (TAVR) using the "All in One" single-artery/vessel technique. Methods: This is a retrospective study. A total of 30 consecutive patients underwent TAVR using the single artery/vascular technique in Beijing Anzhen Hospital from August to December 2021 were included. Baseline clinical data, operative situation, postoperative outcomes, and incidence of adverse events during hospitalization and at one month post TAVR were analyzed. Results: Mean age was (72.6±9.7) years, 16 were male patients, STS score was (4.73±3.12)%. Four patients were diagnosed as isolated aortic regurgitation (all with tricuspid aortic valves), and 26 patients were diagnosed as aortic stenosis (AS), 10 of whom with tricuspid aortic valves and 16 of whom with bicuspid aortic valves. The single-vessel technique was applied in 3 aortic stenosis cases; the single-artery technique was applied in 27 cases. Echocardiography was performed immediately after procedure and results showed no or trace perivalvular leak in 27 cases and small perivalvular leak in 3 cases; the mean aortic transvalvular gradient of 26 AS patients decreased from (50.4±16.0) mmHg (1 mmHg=0.133 kPa) to (9.4±3.2) mmHg (P<0.001). The procedure time was (64.8±18.9) min. There were no intraoperative death, valve displacement, conversion to surgery, coronary artery occlusion in all 30 patients. There were no major cardiac adverse events such as myocardial infarction or stroke occurred during hospitalization or at follow-up. One-month follow-up echocardiography indicated prosthesis works well. The symptoms were significantly alleviated, and the Kansas City Cardiomyopathy Score (KCCQ score) of all patients increased from 48.1±18.4 to 73.5±17.6 (P<0.001). Conclusions: TAVR using the single artery/vessel technique is safe and feasible. This technique is related to reduced access complications and worthy of wide application.

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.

Uso de anticoagulantes orales directos en pacientes con fibrilación auricular post implante de TAVI: resultados de una encuesta internacional / Use of anticoagulants in patients with atrial fibrillation undergoing transcatheter aortic valve implantation

BACKGROUND: Transcatheter Aortic Valve Implantation (TAVI) is beneficial in patients with symptomatic severe Aortic Stenosis (AS). There is no consensus about the best anticoagulation strategy for patients with a recent TAVI and with atrial fibrillation (AF). Direct oral anticoagulants (DOACs) are effective to prevent embolic events with a significant lower incidence of bleeding. There is scarce evidence about the use of these drugs in patients undergoing TAVI. AIM: To assess the management of anticoagulation at the moment of discharge of patients with AF and TAVI. Material and Methods: A four question survey was sent to cardiologists involved in TAVI programs in different international centers. Results: The survey was answered by 72 interventional cardiologists. Even with the lack of randomized evidence, in most of the scenarios DOACs are prescribed at discharge in patients with indication for anticoagulation. Also, in patients with high bleeding risk, most cardiologists would perform a left atrial appendage closure. In patients with concomitant coronary artery disease, if a stent was recently implanted, prescription of the combination of a DOAC and one antiplatelet drug was the most common answer. In patients with a former coronary angioplasty, DOAC or Warfarin was the therapy of choice. CONCLUSIONS: In the absence of randomized data, interventional cardiologists prescribe DOACs at discharge to patients with AF and TAVI, without following current guidelines in most cases.

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.

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.

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 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.

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.

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.