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rate was calculated, which was defined as (1) the device being delivered via the access, deployed, implanted and withdrawn, (2) mean transaortic gradient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 Devices were delivered via the access, deployed, implanted and withdrawn successfully in all patients.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.

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.

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 and mid-term follow-up of elderly patients with severe aortic stenosis not eligible for TAVI

BACKGROUND: The treatment for symptomatic severe aortic stenosis (AS) is the correction of valve stenosis by surgical valve replacement and more recently by transcatheter aortic valve implant (TAVI). However, in some high risk surgical patients, TAVI is not possible for technical or clinical reasons or due to the unavailability of the endoprosthesis. OBJECTIVE: The aim of this study was to evaluate a mid-term follow-up of symptomatic severe AS patients who are not eligible for TAVI trials, as well as to identify the clinical features of these patients. METHODS: This was an observational, retrospective study conducted with 475 symptomatic severe AS patients, evaluated by the Heart Team between 2000 and 2017. Inclusion criterias were: patients considered not to be eligible for TAVI. The Shapiro-Wilk test was applied to evaluate normality. Non-paired t and Mann-Whitney tests were applied for continuous variables, while the chi-squared and Fischer exact tests were applied for categorical variables, with a level of significance of p<0,05. RESULTS: The heart team evaluated 475 patients: 25 (5.26%) died before any intervention could be proposed; 326 (68.3%) were submitted to TAVI, so the study population consisted of 124 patients not eligible for TAVI. Of these, 31 (25%) underwent surgery and 93 (75%) remained in clinical treatment. In a mean 56 months- follow-up the mortality in clinical group was 46.2%. In the surgical group the mortality was 23.9% (in-hospital 12.9% and late mortality 11% in a mean 47.4 months follow-up). The patients that died presented a significantly lower left ventricle ejection fraction (LVEF), a smaller valve area, and a larger end-systolic diameter of the LV. CONCLUSION: The mortality of the clinical group's patients was significantly higher than the surgical mortality (46.2% vs. 12.9%; p=0.021). The patients of the clinical group were older, weighed less, and had a higher incidence of renal failure and a higher STS score.

Transfusion of Blood Products in the Postoperative of Cardiac Surgery

Abstract Background: The indiscriminate use of blood transfusion in surgery has been associated with increased risk of infection and increased length of hospital stay. Objective: To identify the average amount of bleeding and rates of transfusion of blood products in the postoperative period of patients undergoing cardiac surgery in a cardiology center. Methods: Medical records of patients who underwent myocardial revascularization surgery and/or heart valve replacement with use of cardiopulmonary bypass (CPB) were analyzed. Perioperative data such as CPB time, hematocrit and hemoglobin values were collected after surgery. The amount of bleeding (mL), blood transfusion (IU), clinical complications and time of hospitalization were also recorded. The correlation between bleeding in the postoperative period and blood transfusion was performed using the Spearman correlation. A p < 0.05 was considered statistically significant. Results: A total of 423 patients undergoing coronary artery bypass grafting (51.5%) or heart valve replacement (33.6%) were included. During the first 24 hours, the average bleeding volume was 353.3 ± 268.3 mL. Transfusion of blood products was required in 40.1% of cases, most frequently (70.6%) in the immediate postoperative period. Red blood cell concentrate was the most frequently used product (22.9% and 60%). Conclusion: The occurrence of bleeding in the cases was low, and when transfusion of blood components was indicated, red blood cell concentrates were the most widely used component. (Int J Cardiovasc Sci. 2021; [online].ahead print, PP.0-0)

Dos casos de reemplazo transcatéter de válvula aórtica en Honduras, año 2019 / Two cases of aortic valve transcateter replacement in Honduras, 2019

Antecedentes: Las valvulopatías cardiacas se presentan en 1 de 100,000 habitantes en Centro América. La estenosis aórtica representa el 25% de estas patologías. La principal causa es la iebre reumática y en países de ingresos altos, las anomalías congénitas. La valvulopatía aórtica bicúspide es una anomalía rara, presente en 0.5% de la población total. Tradicionalmente en Honduras, las correcciones de estas anomalías se habían hecho con cirugía vascular. Descripción de los casos clínicos: Se presentan los dos primeros casos realizados en Honduras mediante reemplazo transcateter o terapia endovascular (transcatheter aortic valve replacement, TAVR), en el año 2019, en un centro asistencial privado en Tegucigalpa. El primer caso sobre una aorta bivalva, con el apoyo de un sistema En Snare, por el difícil abordaje, con EuroScore II <4%. El segundo caso sobre una estenosis aórtica secundaria a iebre reumática. Ambos procedimientos se ejecutaron sin complicaciones inmediatas o tardías. La ecocardiografía reportó resolución de los gradientes de presión y reducción de la velocidad transvalvular máxima aórtica (Vmax Ao). Conclusión: Siendo esta una terapia de primer mundo, respaldada para pacientes de alto y bajo riesgo quirúrgico, abre la oportunidad a nuestra población de recibir una terapia efectiva, segura y con resultados inmediatos...(AU)

Transcatheter Aortic Valve Implantation: Where are we in 2020?

Abstract Aortic stenosis is an insidious disease of rapid progression after the onset of symptoms. Aortic valve replacement surgery is a well-established therapy that reduces symptoms and increases survival rates. However, the procedure may be associated with high operative mortality rates and promote comorbidity. Depending on the local reality, the prevalence of patients considered inoperable (due to medical comorbidities and age) may achieve 30%. For these patients, transcatheter aortic valve implantation (TAVI) was initially indicated; over time, the method has advanced technologically and been simplified, and become an alternative therapy for patients at low and intermediate surgical risk also, and considered one of the major advances of modern medicine.

Implante valvular aórtico transcatéter (TAVI) e impacto en la sobrevida del paciente / Transcatheter aortic valve implantation (TAVI) and impact on patient survival

El implante valvular aórtico transcatéter, es un procedimiento cardiovascular de mínima invasión y una alternativa frente a la intervención convencional, en insuficiencia aórtica severa. En este trabajo se realiza una revisión de las complicaciones y la sobrevida, en pacientes sometidos a TAVI, frente a remplazo aórtico tradicional. Para ello se realizó una investigación documental con información entre los años 2010-2018. El implante valvular aórtico transcatéter debe efectuarse vía transfemoral o transapical, con una válvula Core o Sapien XT, según la necesidad del individuo, para evitar la regurgitación para valvular. Con este implante disminuyen las complicaciones y se remodela el ventrículo izquierdo; reduciendo la disnea y mejorando el pronóstico vida y la tasa de mortalidad en comparación con otros métodos(AU)

The transcatheter aortic valve implant is a minimally invasive cardiovascular procedure and, an alternative to conventional intervention in severe aortic insufficiency. In this work, a review of complications and survival is performed in patients undergoing TAVI, compared to traditional aortic replacement. For this, a documentary investigation was carried out with information between the years 2010-2018. The transcatheter aortic valve implant should be performed transfemorally or transapically, with a Core or Sapien XT valve, depending on the individual's need, to avoid regurgitation to valvulate. With this implant the complications decrease and the left ventricle is remodeled; reducing breathlessness and improving the life prognosis and mortality rate compared to other methods(AU)

Impact of Transcatheter Aortic Valve Implantation on Kidney Function / Impacto do Implante Percutâneo de Válvula Aórtica na Função Renal

Abstract Background: Chronic kidney disease (CKD) is frequently present in patients with aortic valve disease. Decreased kidney perfusion as a consequence of reduced cardiac output may contribute to renal dysfunction in this setting. Objective: Given the potential reversibility of kidney hypoperfusion after valve repair, this study aimed to analyze the impact of percutaneous transcatheter aortic valve implantation (TAVI) on kidney function. Methods: We performed a retrospective analysis of 233 consecutive patients who underwent TAVI in a single center between November 2008 and May 2016. We assessed three groups according to their baseline estimated glomerular filtration rate (eGFR) (mL/min/1.73 m2): Group 1 with eGFR ≥ 60; Group 2 with 30 ≤ eGFR < 60; and Group 3 with eGFR < 30. We analyzed the eGFR one month and one year after TAVI in these three groups, using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula to calculate it. Results: Patients from Group 1 had a progressive decline in eGFR one year after the TAVI procedure (p < 0.001 vs. pre-TAVI). In Group 2 patients, the mean eGFR increased one month after TAVI and continued to grow after one year (p = 0.001 vs. pre-TAVI). The same occurred in Group 3, with the mean eGFR increasing from 24.4 ± 5.1 mL/min/1.73 m2 before TAVI to 38.4 ± 18.8 mL/min/1.73 m2 one year after TAVI (p = 0.012). Conclusions: For patients with moderate-to-severe CKD, kidney function improved one year after the TAVI procedure. This outcome is probably due to better kidney perfusion post-procedure. We believe that when evaluating patients that might need TAVI, this 'reversibility of CKD effect' should be considered.

Resumo Fundamento: Pacientes com doença valvar aórtica frequentemente apresentam doença renal crônica (DRC). Diminuição da perfusão renal como consequência da redução do débito cardíaco pode contribuir para a disfunção renal neste cenário. Objetivo: Dado o potencial de reversibilidade da hipoperfusão renal após o reparo valvar, este estudo teve o objetivo de analisar o impacto do implante percutâneo de válvula aórtica (TAVI - transcatheter aortic valve implantation) na função renal. Métodos: Foi realizada uma análise retrospectiva de 233 pacientes consecutivos submetidos ao TAVI em um único centro, entre novembro de 2008 e maio de 2016. Três grupos foram avaliados de acordo com a taxa de filtração glomerular estimada (TFGe) basal (mL/min/1,73 m2): Grupo 1 com TFGe ≥ 60; Grupo 2 com 30 ≤ TFGe < 60; e Grupo 3 com TFGe < 30. O TFGe foi analisado nestes três grupos um mês e um ano após o TAVI e calculado usando a fórmula do Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI). Resultados: Os pacientes do Grupo 1 tiveram um declínio progressivo da TFGe um ano após o procedimento TAVI (p < 0,001 vs. pré-TAVI). Nos pacientes do Grupo 2, a média da TFGe aumentou um mês depois do TAVI e continuou crescendo depois de um ano (p = 0,001 vs. pré-TAVI). O mesmo ocorreu no Grupo 3, com a média da TFGe subindo de 24,4 ± 5,1 mL/min/1,73 m2 antes do TAVI para 38,4 ± 18,8 mL/min/1,73 m2 um ano após o TAVI (p = 0,012). Conclusões: Em pacientes com DRC moderada a grave, a função renal melhorou um ano após o procedimento TAVI. Este resultado é provavelmente devido à melhora da perfusão renal pós-procedimento. Acredita-se que, ao avaliar pacientes que possam precisar de TAVI, este 'efeito de reversibilidade da DRC' deva ser considerado.

Incidence of Conduction Disorders and Requirements for Permanent Pacemaker After Transcatheter Aortic Valve Implantation

Transcatheter aortic valve implantation (TAVI) has become a therapeutic option for high-risk or non-operable patients with severe symptomatic aortic stenosis. Atrioventricular conduction disturbances requiring permanent pacemaker (PPM) are a common and clinically important complication. Objectives: To evaluate the incidence of conduction disorders (CDs) after TAVI and the need for subsequent PPM implantation. To identify the predictors of postoperative PPM implantation. Methods: Retrospective study. All patients who underwent TAVI in a public hospital from December/2011 to June/2016 were included. Multivariate analysis was conducted to establish the predictor of permanent pacemaker implantation. Survival curves were constructed by the Kaplan-Meyer method. Statistically significant variables were those with p value < 0.05. Results: 64 patients with AS underwent TAVI. Eleven patients were excluded. TAVI induced a new CD in 40 (77%) of the remaining 53 patients. The most common new CDs were 3rd degree AV block (32%) and left bundle branch block (30%). Sixteen patients (30,2%) underwent PPM implantation during the index hospitalization. On univariate analysis the risk factors for PPM implantation were CoreValve® use (OR: 1,76; P = 0,005), larger prosthesis implantation (P = 0,015), presence of a QRS ≥ 120 ms (OR: 5,62; P = 0,012), and 1st degree AV block (OR: 13; P = 0.008). On multivariate analysis the presence of 1st degree AV block predicted the need for PPM. Conclusion: TAVI induced CDs requiring PPM in 30% of the patients. The presence of 1st degree AV block predicted the need for PPM

Análise crítica dos estudos que mudaram a prática clínica recente: doença valvar / Critical analysis of studies that have changed recent clinical practice: valvular heart disease

Nesta breve análise crítica, discutiremos três estudos com potencial de alterar a prática clínica e as principais diretrizes internacionais no que tange à doença valvar. O estudo PARTNER III foi um estudo que randomizou 1000 pacientes de baixo risco cirúrgico entre troca valvar transcateter e cirurgia convencional, com superioridade da técnica transcateter em um desfecho primário combinado de mortalidade de todas as causas, acidente vascular cerebral (AVC) e re-hospitalização em doze meses de seguimento (8,5%vs.15,1%, p = 0,001). Já o estudo Evolut Low Risk randomizou 1468 pacientes entre as duas técnicas, com um desfecho primário de mortalidade ou AVC incapacitante ao final de dois anos de seguimento que atingiu não-inferioridade na comparação Bayesiana (5,3% transcateter vs . 6,7% cirurgia). Finalmente, discutimos também o estudo COAPT, no qual 614 pacientes foram randomizados entre o dispositivo edge-to-edge MitraClip e o tratamento clínico da insuficiência mitral secundária. Nesses pacientes selecionados, a taxa anualizada de hospitalizações por insuficiência cardíaca foi de 35,8% por paciente-ano no grupo MitraClip, comparado com 67,9% no grupo controle (HR 0,53, IC 95% 0,4-0,7).Nas novas diretrizes, pode-se razoavelmente esperar uma indicação I para a troca valvar transcateter em pacientes de baixo risco e uma indicação IIa para a técnica edge-to-edge em pacientes com características semelhantes aos do COAPT. Esses procedimentos devem ser considerados no contexto do Heart Team para que sejam atingidos os melhores resultados

In this short critical review, we will discuss three trials with the potential to alter clinical practice and the main international guidelines regarding valvular heart disease. The PARTNER III trial was a study of 1000 low surgical risk patients randomized between transcatheter aortic valve replacement (TAVR) and conventional surgery, showing the superiority of the transcatheter technique with a combined primary endpoint of all-cause mortality, stroke and rehospitalization over twelve months of follow-up (8.5%vs. 15.1%, p = 0.001). The Evolut Low Risk trial randomized 1468 patients between the two techniques with a primary endpoint of death or incapacitating stroke at the end of two years of follow-up, achieving non-inferiority in a Bayesian comparison (5.3% TAVR vs. 6.7% surgery). Finally, we also will discuss the COAPT study, in which 614 patients were randomized between the edge-to-edge MitraClip device and clinical treatment for secondary mitral regurgitation. Among these selected patients, the annual rate of hospitalizations for heart failure was 35.8% per patient-year in the MitraClip group, compared with 67.9% in the control group (HR 0.53, 95% CI 0.4-0.7). Under the new guidelines, we may reasonably expect a class I indication for transcatheter valvular replacement in low-risk patients and a class IIa indication for the edge-to-edge technique in patients with characteristics similar to those of the COAPT study. These procedures should be considered within the context of the Heart Team so that the best results are achieved

The negative effect of mean perfusion pressure on the development of acute kidney injury after transcatheter aortic valve implantation

Abstract Objective: To evaluate the predictive value of mean perfusion pressure (mPP) in the development of acute kidney injury (AKIN) after transcatheter aortic valve implantation (TAVI). Methods: One hundred and forty seven consecutive patients with aortic stenosis (AS) were evaluated for this study and 133 of them were included. Mean arterial pressure (mAP) and central venous pressure (CVP) were used to calculate mPP before TAVI procedure (mPP = mAP-CVP). The occurrence of AKIN was evaluated with AKIN classification according to the Valve Academic Research Consortium-2 recommendations. The patients were divided into two groups according to the receiver operating characteristic (ROC) analysis of their mPP levels (high-risk group and low-risk group). Results: The AKIN prevalence was 22.6% in this study population. Baseline serum creatinine level, glomerular filtration rate, amount of contrast medium, and the level of mPP were determined as predictive factors for the development of AKIN. Conclusion: The occurrence of AKIN is associated with increased morbidity and mortality rates in patients with TAVI. In addition to the amount of contrast medium and basal kidney functions, our study showed that lower mPP was strongly associated with development of AKIN after TAVI.

Aortic valve replacement with a conventional stented bioprosthesis versus sutureless bioprosthesis: a study of 763 patients

Abstract Objective: The aim of this retrospective study was to compare early postoperative outcomes after aortic valve replacement (AVR) with sutureless bioprostheses and conventional stented bioprostheses implanted through median sternotomy. Methods: From January 2011 to December 2016, 763 patients underwent aortic valve replacement with bioprostheses; of these, 139 received a Perceval S sutureless valve (Group A) and 624 received a Perimount Magna Ease valve (Group B). These groups were further divided into A1 (isolated Perceval AVR), A2 (Perceval AVR with coronary artery bypass grafting [CABG]), B1 (isolated conventional stented bioprosthesis), and B2 (conventional stented bioprosthesis + CABG). Results: Patients in Group A were older (mean 74 years vs. 71 years; P<0.0001), predominantly women (53% vs. 32%; P<0.0001), had a higher logistic EuroSCORE (3.26 vs. 2.43; P<0.001), more preoperative atrial fibrillation (20% vs. 13%; P=0.03), and had a lower reopening rate for bleeding (2.1% vs. 6.7%; P=0.04). Compared to Group B1, Group A1 had shorter cross-clamp (mean 40 min vs. 57 min; P≤0.0001) and bypass times (mean 63 min vs. mean 80 min; P=0.02), and they bled less postoperatively (mean 295 ml vs. mean 393 ml; P=0.002). The mean gradient across Perceval valve was 12.5 mmHg while its effective orifice area was 1.5 cm2. Conclusion: In our retrospective study of 763 patients, sutureless valve group patients are older, mostly women, more symptomatic preoperatively, and have higher logistic EuroSCORE. They have shorter cross-clamp and bypass times, less postoperative bleeding, and reduced incidence of reopening. Further studies are needed to evaluate the clinical benefits in short, mid, and long-terms.

Aortic valve replacement combined with ascending aortic aneurysmectomy in a patient with sickle cell disease: a case report

Abstract Sickle cell anemia is a haematological disorder characterized by multiple vaso-occlusive complications, resulting in a reduced life expectancy. These patients are exposed to several triggering factors for sickle cell crises when they are submitted to cardiovascular surgeries with extracorporeal circulation. Therefore, meticulous care and perioperative management are required. This paper reports a successful case of combined cardiovascular surgery - aortic valve replacement and ascending aortic aneurysmectomy - with no serious post-operative complications. In this report, we emphasize the peculiarities of perioperative care in patients with sickle cell anemia.

Transcatheter aortic valve replacement: the experience of one brazilian health care center

Abstract Objective: Transcatheter aortic valve replacement has been an alternative to invasive treatment for symptomatic severe aortic stenosis in high risk patients. The primary endpoint was 30-day and 1-year mortality from any cause. Secondary endpoints were to compare the clinical and echocardiographic variation pre-and post- transcatheter aortic valve replacement, and the occurrence of complications throughout a 4-year follow-up period. Methods: This prospective cohort, nestled to a multicenter study (Registro Brasileiro de Implante de Bioprótese por Cateter), describes the experience of a public tertiary center in transcatheter aortic valve replacement. All patients who underwent this procedure between October 2011 and February 2016 were included. Results: Fifty-eight patients underwent transcatheter aortic valve replacement. The 30-day all-cause mortality was 5.2% (n=3) and after 1 year was 17.2% (n=10). A significant improvement in New York Heart Association functional classification was observed when comparing pre-and post- transcatheter aortic valve replacement (III or IV 84.4% versus 5.8%; P<0.001). A decline in peak was observed (P<0.001) and mean (P<0.001) systolic transaortic gradient. The results of peak and mean post-implant transaortic gradient were sustained after one year (P=0.29 and P=0.36, respectively). Left ventricular ejection fraction did not change significantly during follow-up (P=0.41). The most frequent complications were bleeding (28.9%), the need for permanent pacemaker (27.6%) and acute renal injury (20.6%). Conclusion: Mortality and complications in this study were consistent with worldwide experience. Transcatheter aortic valve replacement had positive clinical and hemodynamic results, when comparing pre-and post-procedure, and the hemodynamic profile of the prosthesis was sustained throughout follow-up.

Influence of the tilt angle of Percutaneous Aortic Prosthesis on Velocity and Shear Stress Fields / Influência do Ângulo de Inclinação da Prótese Percutânea Aórtica no Campo de Velocidade e Estresse de Cisalhamento

Abstract Background: Due to the nature of the percutaneous prosthesis deployment process, a variation in its final position is expected. Prosthetic valve placement will define the spatial location of its effective orifice in relation to the aortic annulus. The blood flow pattern in the ascending aorta is related to the aortic remodeling process, and depends on the spatial location of the effective orifice. The hemodynamic effect of small variations in the angle of inclination of the effective orifice has not been studied in detail. Objective: To implement an in vitro simulation to characterize the hydrodynamic blood flow pattern associated with small variations in the effective orifice inclination. Methods: A three-dimensional aortic phantom was constructed, reproducing the anatomy of one patient submitted to percutaneous aortic valve implantation. Flow analysis was performed by use of the Particle Image Velocimetry technique. The flow pattern in the ascending aorta was characterized for six flow rate levels. In addition, six angles of inclination of the effective orifice were assessed. Results: The effective orifice at the -4° and -2° angles directed the main flow towards the anterior wall of the aortic model, inducing asymmetric and high shear stress in that region. However, the effective orifice at the +3° and +5° angles mimics the physiological pattern, centralizing the main flow and promoting a symmetric distribution of shear stress. Conclusion: The measurements performed suggest that small changes in the angle of inclination of the percutaneous prosthesis aid in the generation of a physiological hemodynamic pattern, and can contribute to reduce aortic remodeling.

Resumo Fundamento: Devido à natureza do processo de liberação da prótese percutânea, é esperada uma variabilidade do posicionamento final da válvula. A localização da prótese irá definir a posição espacial do seu orifício efetivo em relação ao ânulo aórtico. O padrão do fluxo sanguíneo em aorta ascendente está relacionado ao processo de remodelamento aórtico, além de ser dependente da disposição espacial do orifício efetivo. O efeito hemodinâmico de pequenas variações na angulação do orifício efetivo ainda não foi estudado em detalhes. Objetivo: O objetivo do presente trabalho foi implementar uma simulação in vitro do fluxo sanguíneo para caracterização do padrão hidrodinâmico, associado a pequenas variações na inclinação do orifício efetivo. Métodos: Para esse fim, foi construído um fantoma aórtico tridimensional, que reproduziu a anatomia de um paciente submetido ao implante valvar percutâneo. A análise de fluxo foi realizada através da técnica de Velocimetria por Imagens de Partícula. O padrão de escoamento em aorta ascendente foi caracterizado para seis níveis de vazão de fluxo. Além disso, foram estudados seis inclinações do orifício efetivo. Resultados: O estudo demonstrou que o orifício efetivo nos ângulos -4° e -2° direcionaram o fluxo principal para a parede anterior do modelo aórtico, induzindo um cisalhamento assimétrico e elevado nessa região. Por outro lado, os ângulos +3° e +5° mimetizam o padrão fisiológico, centralizando o fluxo principal e promovendo uma distribuição simétrica do cisalhamento. Conclusão: As medições realizadas sugerem que pequenas alterações angulares na prótese percutânea auxiliam na geração de um padrão hemodinâmico fisiológico, podendo contribuir para menor remodelamento aórtico.