Concomitant Transcatheter Transfemoral Double Native Valve Replacement for Severe Aortic Stenosis and Severe Mitral Stenosis with Mitral Annular Calcification

Concomitant mitral and aortic valve stenosis in a patient with mitral annular calcification and porcelain aorta poses a unique problem to the surgical team. Transcatheter aortic and mitral valve replacements in native valves offer a viable option for such selected group of patients. We present the case of a 54-year-old male who presented with severe aortic stenosis (AS) and severe mitral stenosis (MS) but was deemed high risk for surgery owing to intense calcification of the aorta and mitral annular calcification, and successfully underwent transcatheter double native valve replacement.

Transcatheter aortic valve replacement in pure native aortic regurgitation: when off-label indications match the patient's requirements / TAVI en IA pura de válvula nativa: cuando indicaciones fuera de guías cumplen los requerimientos del paciente

Abstract Objective: In recent years, transcatheter aortic valve replace (TAVR) has revolutionized the interventional treatment of aortic stenosis, however, only scarce evidence considers it as treatment for Aortic Regurgitation (AR). At present, the treatment of Pure AR of Native Valve with TAVR does not fall within the recommendations of international guidelines, as it poses multiple challenges with immediate and long-term variable and unpredictable results. The objective of this paper is to present the case of a patient with prohibitive operative risk that benefited of TAVR treatment for AR. Materials and methods: We present the case of a 79-year-old male patient who has severe Pure Native Aortic Valve Regurgitation, considered inoperable. Based on the heart team's decision, TAVR was planned with the use of an Edwards SAPIEN 3 valve. After TAVR, the patient developed complete heart block and a pacemaker was implanted. He improved to NYHA II functional class. At 15-month follow-up, he suffered intracranial hemorrhage and passed away. Results and Conclusions: Management of patients with severe symptomatic AR with high surgical risk continues to be a special challenge. They have high mortality if left untreated with valvular change, despite medical treatment. Even though it is strictly off-label, TAVR might be a reasonable solution for a select type of patients who are considered inoperable due to surgical high mortality risk.

Resumen Objetivo: En años recientes, el reemplazo valvular aórtico vía percutánea (TAVI) ha revolucionado el tratamiento de los pacientes con estenosis aórtica, sin embargo, poca evidencia la considera como opción de tratamiento en pacientes con insuficiencia aórtica (IA), especialmente en pacientes con Insuficiencia Aórtica Pura de Válvula Nativa (IAPVN), dado que esta patología confiere múltiples retos con resultados muy variables tanto a corto como a largo plazo. Dada su alta mortalidad en caso de permanecer sin tratamiento, la primera opción de tratamiento es la cirugía de cambio valvular. Material y Métodos: Presentamos el caso de un masculino de 79 años con IAPVN grave considerado inoperable dadas las comorbilidades. De acuerdo con la decisión del equipo de Cardiología, se decidió realizar TAVI con la colocación de una Válvula Edwards SAPIEN 3. El paciente desarrolló bloqueo AV completo como única complicación y se colocó marcapasos permanente. Permaneció en clase funcional NYHA II. A los 15 meses de seguimiento presentó hemorragia intracraneal y falleció. Resultados y Conclusiones: El manejo de los pacientes con IAPVN grave sintomática con riesgo quirúrgico alto sigue siendo un reto especial. Tienen alta mortalidad si no se realiza cambio valvular a pesar de tratamiento médico. A pesar de que no se recomienda en las guías actuales, la TAVI puede ser una opción razonable para un grupo muy selecto de pacientes que son considerados inoperables.

Meta-analysis of ProGlide versus MANTA vascular closure devices for large-bore access site management

Introduction: The comparative effectiveness of ProGlide® compared with MANTA® vascular closure devices (VCDs) in large-bore access site management is not entirely certain, and has only been evaluated in underpowered studies. This meta-analysis aimed to evaluate the outcomes of ProGlide® compared with MANTA® VCDs. Methods: PubMed, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched systematically for relevant articles from the inception of the database until August 27, 2021. The outcomes of interest were all bleeding events, major bleeding, major and minor vascular complications, pseudoaneurysm, stenosis or dissection, and VCD failure. Risk ratios were used as point estimates of endpoints. All statistical analyses were carried out using R version 4.0.3. Results: Four observational studies and 1 pilot randomized controlled trial (RCT) were included in the final analysis. There was no significant difference between the ProGlide® and MANTA® groups in the risk of all bleeding events, major/life-threatening bleeding, major vascular complications, minor vascular complications, pseudoaneurysms, and/or stenosis or dissection of the entry site vessel. However, the incidence of VCD failure was higher in the ProGlide® group compared with the MANTA® group (RR 1.94; 95% CI 1.31e2.84; I2 ¼ 0%). Conclusion: In conclusion, both VCDs (ProGlide® and MANTA®) have comparable outcomes with regard to risk of bleeding, vascular complications, pseudoaneurysms, and/or stenosis or dissection of entry vessel. ProGlide® was however associated with higher device failure.

Comparison of 1-year clinical results of transcatheter aortic valve replacement (TAVR) using prostheses with two different frame designs in 124 patients in a single center / 中国胸心血管外科临床杂志

@#Objective    To compare and analyze the clinical effects of two kinds of frame design valves after transcatheter aortic valve replacement (TAVR). Methods    We retrospectively reviewed 124 patients who underwent TAVR and were followed up for 1 year. There were 71 males and 53 females aged 75.57±6.21 years. These patients were treated with Venus-A or Edwards Sapien aortic valves. The hemodynamics and cardiac function of these two kinds of transcatheter aortic valves (THV) were evaluated by echocardiography. The 30-day mortality and 1-year clinical effect of the patients were calculated. Results    Eight-one patients used Venus-A valve and 43 patients used Edwards Sapien valve. The aortic valve transaortic pressure gradient was reduced and the rate of perivalvular leakage was low (both 2.6%) in both groups, and there was no statistical difference between the two groups. The implantation rate of permanent pacemaker was 17.3% and 11.6%, respectively. The 1-month survival (94.0% and 93.0%) and 1-year survival (94.0% and 91.0%) rates were not statistically different. Conclusion    The two groups of THV with different stent structures have good short-term clinical effect and low implantation rate of permanent pacemaker.

The 1-year follow-up results of intraprocedural valve-in-valve deployment for treatment of aortic regurgitation following transcatheter aortic valve replacement (TAVR) in a single center / 中国胸心血管外科临床杂志

@#Objective    To evaluate the efficiency and safety of intraprocedural valve-in-valve deployment for treatment of aortic regurgitation following transcatheter aortic valve replacement (TAVR). Methods    Consecutive patients (n=333) who diagnosed with severe aortic stenosis and underwent TAVR in Zhongshan Hospital affiliated to Fudan University from October 3rd, 2010 to April 21st, 2021 were included. There were 208 males and 125 females aged 76.0±7.0 years. There were 316 patients underwent simple TAVR (simple TAVR group) and 17 patients underwent intraprocedural valve-in-valve deployment following TAVR (valve-in-valve group). Their clinical and echocardiographic outcomes were evaluated and compared. Results    There was no significant difference between the two groups of patients at postoperative 30 d and 1 year in all-cause mortality (4.4% vs. 0, P=1.000; 6.3% vs. 0, P=1.000), incidence of pacemaker implantation (10.4% vs. 17.6%, P=1.000; 11.8% vs. 17.6%, P=1.000), incidence of ischemic stroke (1.3% vs. 0, P=1.000; 1.3%  vs. 0, P=1.000), mean trans-aortic pressure gradient (11.4±6.4 mm Hg vs. 8.9±4.9 mm Hg, P=0.099; 10.5±7.6 mm Hg vs. 11.2±5.2 mm Hg, P=0.432), left ventricular ejection fraction (62.0%±9.0% vs. 57.0%±12.0%, P=0.189; 63.0%±7.0% vs. 60.0%±8.0%, P=0.170), and incidence of mitral valve dysfunction (0.6% vs. 5.9%, P=1.000; 0.6% vs. 5.9%, P=1.000). Conclusion    It is feasible to treat perivalvular leakage with valve-in-valve technology in the procedure of TAVR, and the short and medium-term effects are satisfied.

An interpretation of the 2-year follow-up results of Evolut Low Risk research / 中国胸心血管外科临床杂志

@#Transcatheter aortic valve replacement (TAVR) has become a well-established treatment for patients with severe aortic stenosis. At present, TAVR has already shown noninferiority and even superiority to surgical aortic valve replacement (SAVR) in patients deemed at high or intermediate risk for SAVR. However, the long-term follow-up results of the randomized controlled trials comparing the efficacy and safety between TAVR and SAVR are still lacking in those patients who are at low risk for SAVR. This paper gives an overview and reviews results of the Evolut Low Risk trial and interprets its implications for transcatheter therapy in aortic valve diseases.

Implications of five-year outcomes of COMMENCE (SAVR) trial for aortic valve surgery in China / 中国胸心血管外科临床杂志

@#The advent of transcatheter aortic valve replacement (TAVR) has brought up a new treatment option for patients with severe aortic valve disease. However, with the continuous expansion of surgical indications, problems such as structural valve deterioration caused by biological prosthesis have become increasingly prominent. In the newly announced 5-year follow-up results of COMMENCE (SAVR) trial, the aortic bioprosthesis using the new RESILIA biotissue material demonstrated extraordinary clinical safety, efficacy and durability with zero structural valve deterioration and excellent hemodynamic evaluation results. As a result, patients with valvular heart disease have more diverse therapeutic options. However, the choice between surgical aortic valve replacement (SAVR) and TAVR, biological prosthesis and mechanical prosthesis, etc, has become more and more prominent, which brings more difficulties to clinicians. This paper reviews the research background, 5-year follow-up results of COMMENCE trial and the implications for aortic valve surgery in China.

Safety of transcatheter aortic valve replacement through different approaches: A systematic review and meta-analysis / 中国胸心血管外科临床杂志

@#Objective    To evaluate the early and mid-term safety of transcatheter aortic valve replacement via transfemoral (TF), transapical (TAp) and transsubclavian (TSc) approaches by meta-analysis. Methods    We systematically searched the clinical comparative trials published from inception to June 2019 from PubMed, Web of Science, EMbase and The Cochrane Library, to evaluate the safety of transcatheter aortic valve replacement through TF, TAp or TSc approaches. The information of all-cause mortality at 30 days, 1 year, 2 years and the incidence of common complications at 30 days after operation (including pacemaker-dependent block, major vascular complications, severe bleeding events, acute renal injury and stroke) were exacted, and a meta-analysis was conducted by RevMan 5.3 software. Results    This study included 11 literatures, with a total of 7 833 patients, among whom 5 348 patients were treated by TF TAVR, 1 796 patients by TAp TAVR and 689 patients by TSc TAVR. The results of the meta-analysis were as follows: (1)  at 30 days after operation, the mortality of TF and TSc approaches were lower than that of the TAp approach (TF vs. TAp:OR=0.57, 95%CI 0.39-0.84, P=0.004; TSc vs. TAp: OR=4.12, 95%CI 1.93-8.79, P=0.000 3). There was no statistical difference between the TF and TSc approaches (TF vs. TSc: OR=0.98, 95%CI 0.38-2.51, P=0.97); at 1 year, there was no statistical difference in mortality among the three approaches (P>0.05); at 2 years, there was no statistical difference between TSc and TF or TAp approaches (TF vs. TSc: OR=1.21, 95%CI 0.95-1.54, P=0.13; TSc vs. TAp: OR=1.02, 95%CI 0.76-1.36, P=0.91). (2) The incidence of acute kidney injury after TF approach was lower than that of the TAp approach (OR=0.30, 95%CI 0.22-0.41, P<0.000 01). (3) There was no statistical difference in major vascular complications between TSc and TF or TAp approaches (TF vs. TSc: OR=0.75, 95%CI 0.38-1.49, P=0.41; TSc vs. TAp: OR=1.37, 95%CI 0.56-3.32, P=0.49). (4) There was no statistical difference in severe bleeding events between TF and TSc (OR=0.97, 95%CI 0.53-1.76, P=0.92). (5) There was no statistical difference in the incidence of postoperative stroke, pacemaker dependent block among the three approaches (P>0.05). Conclusion    TAp and TSc approaches are safe and effective. They are not only an alternative to TF approach, but also the first choice in some patients with poor condition of iliofemoral artery.

Efficacy and safety of transapical transcatheter aortic valve replacement in the treatment of aortic regurgitation in patients with large aortic annulus / 中国胸心血管外科临床杂志

@#Objective    To investigate the feasibility and safety of transcatheter aortic valve replacement (TAVR) through apical approach for aortic regurgitation of large annulus. Methods    From November 2019 to May 2020, 10 male patients aged 64.50±4.20 years with aortic valve insufficiency (AI) underwent TAVR in the Department of Cardiovascular Surgery, Xijing Hospital. The surgical instruments were 29# J-valveTM modified and the patients underwent TAVR under angiography. The preoperative and postoperative cardiac function, valve regurgitation, complications and left ventricular remodeling were summarized by ultrasound and CT before and after TAVR. Results    A total of 10 valves were implanted in 10 patients. Among them, 1 patient was transferred to the aortic arch during the operation and was transferred to surgical aortic valve replacement; the other 9 patients were successfully implanted with J-valve, with 6 patients of cardiac function (NYHA) class Ⅱ, 4 patients of grade Ⅲ. And there was a significant difference between preoperation and postoperation in left ventricular ejection fraction (44.70%±8.78% vs. 39.80%±8.48%, P<0.05) or aortic regurgitation (1.75±0.72 mL vs. 16.51±8.71 mL, P<0.05). After 3 months, the patients' cardiac function was good. Conclusion    TAVR is safe and effective in the treatment of severe valvular disease with AI using J-valve.

Reflections on the era of valvular intervention—The perspective of surgeons / 中国胸心血管外科临床杂志

@#In recent years, the number of interventions for valvular heart disease has been increasing day by day, and it has become a hot topic in the field of cardiovascular surgery. Given the aging global population and trends in the prevalence of valvular disease and the broadening of indications for transcatheter aortic valve replacement (TAVR), a breakthrough of 130 000 TAVR procedures is expected by 2026. In the new technology development period, the development potential and technical advantages of heart valve interventional therapy should be faced squarely. This paper focuses on key issues such as comparison of outcomes after TAVR versus surgical aortic valve replacement (SAVR), prosthetic valve endocarditis after TAVR, and broadening of indications for TAVR, as well as recommendations on how surgeons face the era of TAVR. We hope that this article will help and attract the attention of cardiac surgeons.

Reemplazo valvular aórtico por cateterismo. Estado actual / Aortic valvular replacement by catheterism. Current state

Resumen La estenosis aórtica grave es una enfermedad común cuya prevalencia crece con el envejecimiento de la población. El reemplazo valvular aórtico quirúrgico (SAVR) ha sido la única alternativa efectiva hasta la aparición del reemplazo valvular aórtico por cateterismo (TAVR o TAVI). Este procedimiento se usó inicialmente para pacientes inoperables en quienes dos ensayos clínicos aleatorios y varios registros mostraron su superioridad sobre el tratamiento médico conservador. Dos ensayos clínicos adicionales en pacientes que, a pesar de ser considerados operables, tenían alto riesgo quirúrgico, demostraron la no inferioridad de TAVR versus reemplazo quirúrgico. Investigaciones posteriores probaron también su efectividad en pacientes de riesgo intermedio y bajo. Algunas complicaciones, como las relacionadas al acceso vascular, el accidente cerebro vascular, la necesidad de marcapasos definitivo y la regurgitación periprotésica, han ido disminuyendo con la mejoría de la tecnología, la curva de aprendizaje y la estrategia mínimamente invasiva actual. Queda pendiente determinar la durabilidad para establecer cuál será el papel de TAVR en la práctica clínica.

Abstract Severe aortic stenosis is a common disease whose prevalence is steadily growing with population ageing. Surgical aortic valve replacement (SAVR) has been the only effective alternative until the introduction of transcatheter aortic valve replacement (TAVR or TAVI). This procedure was initially used for non-surgical candidate patients where two randomized clinical trials and several registries showed superiority over conservative medical treatment. Furthermore, two additional clinical trials including high surgical risk patients proved the non-inferiority of TAVR versus surgical replacement. Similar findings regarding effectiveness were observed in other clinical trials including intermediate and low risk patients. Technical and procedural improvements, including learning curve and the current minimally invasive strategy have decreased periprocedural and mid-term complications such as those related with vascular access, stroke, the need for permanent pacemaker implantation and paravalvular leak. All things considered, durability is a pending question to establish which would be the role of TAVR in current and future practice.

Lo mejor del Congreso Uruguayo de Cardiología 2019 / The best of the 2019 Uruguayan Congress of Cardiology / O melhor do Congresso Uruguaio de Cardiologia 2019

Resumen: El 35° Congreso Uruguayo de Cardiología tuvo lugar en Punta del Este, del 7 al 9 de noviembre. Como cada año, constituyó una oportunidad de actualización en diferentes áreas de la cardiología, contando con la participación de invitados nacionales e internacionales. Asimismo, se dio a conocer la actividad científica desarrollada por diferentes autores mediante la exposición de temas libres. A continuación, comentamos los siete artículos premiados por el Comité Científico. - Prevención de muerte súbita (PREMUDE) en jugadores de fútbol: 10 años de valoración precompetitiva. - Perfil clínico de la fibrilación auricular en el posoperatorio de cirugía cardíaca. - Protocolo de cardio-oncología para el seguimiento de pacientes con riesgo de disfunción ventricular por quimioterapia. - Implicancia del uso del score de calcio coronario en la re-estratificación del riesgo cardiovascular en prevención primaria. - Análisis de la morbimortalidad asociada a implante percutáneo de válvula aórtica: valor de variables clínicas y scores de riesgo a mediano plazo. - Anticoagulación en bioprótesis valvular aórtica. Ensayo clínico randomizado multicéntrico. - Strain global longitudinal del ventrículo izquierdo permite predecir mejoría funcional y sobrevida en pacientes con insuficiencia mitral severa asintomática y función normal. Metaanálisis.

Summary: The 35th Uruguayan Congress of Cardiology was held in Punta del Este in November 7th to 9th. As every year, it was an opportunity to update in different cardiovascular areas with participation of national and international guests. Scientific activity of different authors was also announced, through exposition of several articles. We will comment the seven awarded abstracts. - Sudden death prevention (PREMUDE) in soccer players: 10 years of pre-competitive assessment. - Clinical profile of atrial fibrillation in the postoperative period of cardiac surgery. - Cardio-oncology protocol for the follow-up of patients at risk of ventricular dysfunction due to chemotherapy. - Implication of the use of coronary calcium score in the re-stratification of cardiovascular risk in primary prevention. - Analysis of morbidity and mortality associated with percutaneous aortic valve implantation: value of clinical variables and medium-term risk scores. - Anticoagulation in aortic valve bioprosthesis. Multicenter randomized clinical trial. - Longitudinal global left ventricular strain allows prediction of functional improvement and survival in patients with severe asymptomatic mitral regurgitation and normal function. Meta-analysis.

Resumo: O 35º Congresso Uruguaio de Cardiologia, aconteceu em Punta del Este, de 7 a 9 de novembro. Como todos os anos, foi uma oportunidade de atualização em diferentes áreas cardiológicas, graças à experiência de convidados nacionais e internacionais. Também foi anunciada a atividade científica de diferentes serviços, através da exposição de vários artigos. Propomos comentar os sete artigos premiados. - Prevenção de morte súbita (PREMUDE) em jogadores de futebol: 10 anos de avaliação pré-competitiva. - Perfil clínico da fibrilação atrial no pós-operatório de cirurgia cardíaca. - Protocolo cardio-oncológico para acompanhamento de pacientes com risco de disfunção ventricular devido à quimioterapia. - Implicação do uso do escore de cálcio coronariano na ré estratificação do risco cardiovascular na prevenção primária. - Análise da morbimortalidade associada ao implante valvar aórtico percutâneo: valor de variáveis clínicas e escores de risco a médio prazo. - Anticoagulação na bioprótese valvar aórtica. Ensaio clínico randomizado multicêntrico. - O strain global longitudinal do ventrículo esquerdo permite predizer melhora funcional e sobrevida em pacientes com insuficiência mitral assintomática grave e função normal. Meta-análise.

Application of transcatheter aortic valve replacement in patients with bicuspid aortic valve stenosis / 中国实用内科杂志

Bicuspid aortic valve stenosis(BAVs) is a relative contraindication for transcatheter aortic valve replacement(TAVR) because of its abnormal anatomical structures and pathological characteristics that result in a lower device success rate in BAVs than that in patients with tricuspid aortic valve. However, with the optimization of TAVR strategies and the application of new-generation devices,the effect of TAVR treatment on BAVs patients has been improved. Thus, the article is to introduce the characteristics of BAVs and the progress of TAVR in treatment of BAVs.

TAVI in Intermediate-risk patients: a review in purpose of a case / TAVI en pacientes de riesgo intermedio: una revisión a propósito de un caso

Abstract: Background: Aortic stenosis is the most common valvular heart disease worldwide. The prognosis is adverse without a valve replacement. Transcatheter aortic valve implantation (TAVI) has proven to be an effective treatment in high-surgical risk patients. Recent trials have highlighted the non-inferiority of TAVI compared with open surgery in patients with intermediate surgical risk. Case report: A 76-year-old man with severe aortic stenosis and intermediate surgical risk (STS-PROM 4.8%) who underwent TAVI with no complications. Results: Hospital discharge was decided five days after the procedure and continued outpatient follow-up. After two years remains in NYHA functional class I with a normofunctional percutaneous prosthesis. Conclusion: As this clinical case shows, TAVI has proven to be an effective treatment in patients with aortic stenosis and intermediate surgical risk. This is the first experience in this type of patients reported in our country.(AU)

Resumen: Antecedentes: La estenosis aórtica es la valvulopatía más común en todo el mundo. El pronóstico es sombrío sin reemplazo valvular. La implantación valvular aórtica transcatéter (TAVI) ha demostrado ser un tratamiento eficaz en pacientes de alto riesgo quirúrgico. Ensayos muy recientes destacaron la no-inferioridad de TAVI en comparación con la cirugía abierta en pacientes con riesgo quirúrgico intermedio. Caso clínico: Se presenta un hombre de 76 años de edad con estenosis aórtica severa y riesgo quirúrgico intermedio (STS-PROM 4.8%), al que se realiza TAVI sin complicaciones. Resultados: El alta hospitalaria se decide cinco días después del procedimiento para continuar el seguimiento ambulatorio. Después de dos años, el seguimiento permanece en la clase funcional I de la NYHA con una prótesis percutánea normofuncional. Conclusión: Como muestra este caso clínico, TAVI ha demostrado ser un tratamiento eficaz en pacientes de riesgo quirúrgico intermedio. Ésta es la primera experiencia en el uso de esta tecnología en este tipo de pacientes reportada en nuestro país.(AU)

Dynamic Anatomy of Aortic Root and Its Potential Role in TAVR Prostheses Further Development and Modification.

Aortic stenosis (AS) is the most common valvular disorder. Surgical aortic valve replacement is the definitive therapy for patients with severe AS. In the last years transcatheter aortic valve replacement (TAVR) has been developed as an alternative to surgical aortic valve replacement with promising results. Despite being less invasive than open-chest aortic valve replacement, good outcome and effectiveness of TAVR procedure, it remains associated with the potential for serious complications and short-time durability. Today there are two TAVR prostheses that have CE marks and FDA approved: Edwards Valves and CoreValve. Besides there are many other newly developed TAVR prostheses on the stage of clinical trials. However, no one of them had been developed on the base of data for dynamic anatomy of human aortic root because of the lack of appropriate imaging modality. Today, different two-dimensional (2D) and three-dimensional (3D) imaging techniques are used for aortic root examination. But no one of them has been accepted as a “gold standard” imaging modality for assessment of dynamic anatomy of aortic root. The existing imaging modalities such as transthoracic echocardiography, transesophageal echocardiography, angiography, CT and MRI scans provide tangential cut plane view which did not reflect the real sizes of the annulus and other aortic root rings and structures. Obtained with these modalities images did not reflect the changes of the size and shapes of the anatomic structures of aortic root during the different phase of cardiac cycles either. Today there are strict needs for imaging modality which could assist in assessment of dynamic aortic root to push the TAVR prosthesis design and modification on new level.