The Effect of Aortic Angulation on Clinical Outcomes of Patients Undergoing Transcatheter Aortic Valve Replacement

ABSTRACT Introduction: The aim of this study was to assess the impact of aortic angulation (AA) on periprocedural and in-hospital complications as well as mortality of patients undergoing Evolut™ R valve implantation. Methods: A retrospective study was conducted on 264 patients who underwent transfemoral-approach transcatheter aortic valve replacement with self-expandable valve at our hospital between August 2015 and August 2022. These patients underwent multislice computer tomography scans to evaluate AA. Transcatheter aortic valve replacement endpoints, device success, and clinical events were assessed according to the definitions provided by the Valve Academic Research Consortium-3. Cumulative events included paravalvular leak, permanent pacemaker implantation, new-onset stroke, and in-hospital mortality. Patients were divided into two groups, AA ≤ 48° and AA > 48°, based on the mean AA measurement (48.3±8.8) on multislice computer tomography. Results: Multivariable logistic regression analysis was performed to identify predictors of cumulative events, utilizing variables with a P-value < 0.2 obtained from univariable logistic regression analysis, including AA, age, hypertension, chronic renal failure, and heart failure. AA (odds ratio [OR]: 1.73, 95% confidence interval [CI]: 0.89-3.38, P=0.104), age (OR: 1.04, 95% CI: 0.99-1.10, P=0.099), hypertension (OR: 1.66, 95% CI: 0.82-3.33, P=0.155), chronic renal failure (OR: 1.82, 95% CI: 0.92-3.61, P=0.084), and heart failure (OR: 0.57, 95% CI: 0.27-1.21, P=0.145) were not found to be significantly associated with cumulative events in the multivariable logistic regression analysis. Conclusion: This study demonstrated that increased AA does not have a significant impact on intraprocedural and periprocedural complications of patients with new generation self-expandable valves implanted.

Presencia de regurgitación moderada o grave luego del implante percutáneo de la válvula aórtica con la estrategia de "Cusp Overlap" / Presence of Moderate or Severe Regurgitation after Transcatheter Aortic Valve Implant with the Cusp Overlap Strategy

RESUMEN Objetivo : Analizar si la estrategia del implante alto usando superposición de las cúspides derechas e izquierdas (Cusp Overlap, COVL) en el implante percutáneo de la válvula aórtica (TAVI) se relaciona con menor incidencia de regurgitación paravalvular (RPV) moderada o grave, comparada con la estrategia convencional (CON). Material y métodos : Se analizaron 206 pacientes consecutivos que recibieron TAVI con válvulas autoexpandidles entre agosto de 2019 y mayo de 2022. Se utilizó una estrategia CON en 101 pacientes (49%) y COVL en 105 (51%). El Punto Final Primario (PFP) fue la presencia de regurgitación paravalvular moderada y grave a 30 días. Resultados : No hubo diferencia clínica entre los grupos en cuanto a la edad media, sexo ni comorbilidades; excepto una tendencia a más diabetes y angioplastia coronaria previa en el grupo COVL. El STS score fue mayor en el grupo de COVL (6,9 ± 2,2 vs. 5,8 ± 2,4 en CON, p = 0,01). A 30 días no hubo diferencia en el PFP (RPV moderada en 2% en CON, y 0,9% en COVL; ninguno presentó RPV grave). Tampoco hubo diferencia en mortalidad, infarto, oclusión coronaria, accidente cerebrovascular, sangrado mayor y complicación vascular. La necesidad de marcapasos definitivo fue menor con la estrategia de COVL (6,7% vs. 17,8%, p = 0,01) y un nuevo bloqueo de rama izquierda ocurrió en 5,7% vs. 12,9% (p = 0,07). Conclusiones : En esta serie de un solo centro, la estrategia del implante alto de la válvula aórtica percutánea usando la técnica de COVL no demostró diferencia en la presencia de regurgitaciones moderadas o graves comparada con la estrategia convencional, sin presentar diferencia en las complicaciones, y se asoció a una menor necesidad de marcapasos definitivo y a una tendencia de menos bloqueos de rama izquierda a 30 días.

ABSTRACT Objective : The aim of this study is to whether higher transcatheter aortic valve implantation (TAVI) with self-expandable valves using the right and left cusp overlap strategy (Cusp Overlap, COVL) is associated with a lower incidence of moderate or severe paravalvular regurgitation, compared with the conventional strategy (CON). Methods : A total of 206 consecutive patients undergoing TAVI with self-expandable valves between August 2019 and May 2022 were analyzed. The CON technique was used in the first 101 patients (49%) and COVL was used in 105 (51%). The primary endpoint (PEP) was the presence of moderate or severe paravalvular regurgitation at 30 days. Results : There were no clinical differences between the groups in terms of mean age, sex or comorbidities, except for a trend towards more patients with diabetes and previous percutaneous coronary intervention in the COVL group. The STS score was greater in the COVL group (6.9 ± 2.2 vs. 5.8 ± 2.4 in the CON group; p = 0.01). There was no difference in the PEP at 30 days with 2% incidence of moderate PVR in the CON group and 0.9% in the COVL group, and none of them presented severe PVR. There were no differences in mortality, myocardial infarction, coronary artery obstruction, stroke, major bleeding or vascular complications. The need for permanent pacemaker was lower with the COVL strategy (6.7% vs. 17.8%, p = 0.01) and a new left bundle branch block occurred in 5.7% vs. 12.9% (p = 0.07). Conclusions : In this single-center series, the strategy of high transcatheter aortic valve implantation using the COVL strategy showed no difference in the presence of moderate or severe regurgitation compared with the conventional strategy, with no differences in complications, and was associated with a lower need for definitive pacemaker and with a trend towards lower incidence of left bundle branch block at 30 days.

Reemplazo endovascular aórtico en un paciente con enfermedad de válvula aórtica bicúspide / Endovascular aortic replacement in a patient with bicuspid aortic valve disease

Resumen Un varón de 49 años ingresó en la unidad de cuidados coronarios, con antecedentes de miocardiopatía dilatada, con función sistólica del ventrículo izquierdo gravemente deteriorada y estenosis aórtica grave de origen bicúspide, sintomático para síncope, ángor y disnea de reciente diagnóstico. Durante la internación evolucionó con shock cardiogénico que requirió doble soporte inotrópico. Por presentar alto riesgo quirúrgico y elevada probabilidad de rechazo ante un eventual trasplante cardiaco, según sus estudios de histocompatibilidad, se procedió al reemplazo transcatéter de la válvula aortica, con evolución favorable.

Abstract A 49-year-old male with a history of left ventricular systolic function dilated cardiomyopathy and severe symptomatic bicuspid aortic stenosis recently diagnosed (syncope, chest pain and dyspnea) was admitted to the coronary care unit. During hospitalization, he developed cardiogenic shock requiring double inotropic support. High surgical risk and an elevated chance of graft rejection contraindicated surgical replacement or heart transplant. We performed a transcatheter aortic valve replacement with a favorable evolution.

Características y predictores ecocardiográficos de mortalidad en pacientes intervenidos con TAVI. La importancia de anticiparse al daño cardíaco global

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.

Anesthetic Management for Transcatheter Aortic Valve Replacement: A National Anesthesia Clinical Outcomes Registry Analysis

Background: General anesthesia has traditionally been used in transcatheter aortic valve replacement; however, there has been increasing interest and momentum in alternative anesthetic techniques. Aims: To perform a descriptive study of anesthetic management options in transcatheter aortic valve replacements in the United States, comparing trends in use of monitored anesthesia care versus general anesthesia. Settings and Design: Data evaluated from the American Society of Anesthesiologists� (ASA) Anesthesia Quality Institute抯 National Anesthesia Clinical Outcomes Registry. Materials and Methods: Multivariable logistic regression was used to identify predictors associated with use of monitored anesthesia care compared to general anesthesia. Results: The use of monitored anesthesia care has increased from 1.8% of cases in 2013 to 25.2% in 2017 (p = 0.0001). Patients were more likely ages 80+ (66% vs. 61%; p = 0.0001), male (54% vs. 52%; p = 0.0001), ASA physical status > III (86% vs. 80%; p = 0.0001), cared for in the Northeast (38% vs. 22%; p = 0.0001), and residents in zip codes with higher median income ($63,382 vs. $55,311; p = 0.0001). Multivariable analysis revealed each one-year increase in age, every 50 procedures performed annually at a practice, and being male were associated with 3% (p = 0.0001), 33% (p = 0.012), and 16% (p = 0.026) increased odds of monitored anesthesia care, respectively. Centers in the Northeast were more likely to use monitored anesthesia care (all p < 0.005). Patients who underwent approaches other than percutaneous femoral arterial were less likely to receive monitored anesthesia care (adjusted odds ratios all < 0.51; all p = 0.0001). Conclusion: Anesthetic type for transcatheter aortic valve replacements in the United States varies with age, sex, geography, volume of cases performed at a center, and procedural approach.

Pre?Procedural Serum Albumin Concentration is Associated with Length of Stay, Discharge Destination, and 90?Day Mortality in Patients After Transcatheter Aortic Valve Replacement

Background: As visceral protein expression may influence outcomes in patients with cardiovascular disease, we investigated whether pre-procedural albumin concentration is associated with length of stay (LOS) and 90-day mortality after transcatheter aortic valve repair (TAVR). Methods: We retrospectively analyzed data from TAVR patients at our institution between January 2013 and December 2017. For all patients, baseline albumin concentration was assessed between one and four weeks before the procedure. To investigate the association between albumin concentration and outcomes, we performed regression analyses, controlling for Society of Thoracic Surgeons, New York Heart Association classification, and Kansas City Cardiomyopathy Questionnaire 12 scores. Results: Three hundred eighty patients were included in the analyses. Cox-proportional hazards regression showed that patients with albumin concentrations <3.5 g/dL were 80% more likely to have prolonged ICU LOS (HR 1.79; 95%CI 1.04�57, P = 0.03) and 70% more likely to have prolonged hospital LOS (HR 1.68; 95%CI 1.01?2.46, P = 0.04) compared to patients with albumin concentrations >3.5 g/dL. Logistic regression showed that patients with albumin concentrations <3.5 g/dL were four times more likely to not survive to 90 days (OR 3.94; 1.13�.63, P = 0.03) after their TAVR compared to patients with albumin concentrations >3.5 g/dL. Conclusion: Our data suggest that patients with pre?procedural albumin concentrations <3.5 g/dL are at an increased risk of adverse outcomes after TAVR compared to patients with albumin concentrations ?3.5 g/dL. Prospective studies are needed to determine whether risk stratification based on pre-procedural albumin can improve outcomes and whether targeted interventions can improve pre-procedural albumin concentrations in potential TAVR candidates.

Clinical outcomes of MANTA vs suture-based vascular closure devices after transcatheter aortic valve replacement: An updated meta-analysis

Objective: A recently published randomized control trial showed different results with suture-based vascular closure device (VCD) than plug-based VCD in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). The learning curve for MANTA device is steep, while the learning curve for suture based VCD is shallow as the devices are quite different. In this meta-analysis, we have compared suture-based (ProGlide and Prostar XL) vs plug-based VCDs (MANTA). Methods: We performed a meta-analysis of all published studies (using PubMed/Medline and Cochrane databases) reporting the clinical outcome of plug-based vs suture-based VCDs in transfemoral TAVR patients. Results: We included nine studies with a total of 2865 patients (plug-based n ¼ 1631, suture-based n ¼ 1234). There was no significant difference in primary outcome of all bleeding when using plugbased as opposed to suture-based VCDs (RR 1.14 [0.62e2.06] I2 ¼ 72%). There was no significant difference in the incidence of secondary outcomes between two groups including major life threatening bleeding (RR 1.16 [0.38e3.58] I2 ¼ 65%), major vascular complications (RR 0.84 [0.35e2.00] I2 ¼ 55%), minor vascular complications (RR 1.05 [0.56e1.95] I2 ¼ 42%), pseudo aneurysm (RR 1.84 [0.11e29.98] I 2 ¼ 44%), stenosis-dissection (RR 0.98 [0.66e1.47] I2 ¼ 0%), VCD failure (RR 1.71 [0.96e3.04] I2 ¼ 0%), and blood transfusion (RR 1.01 [0.38e2.71], I2 ¼ 61%). Conclusion: Large bore arteriotomy closure with plug-based VCD was not superior to suture-based VCDs in this transfemoral TAVR population. There was very frequent use of secondary VCDs in suture-based VCD group which is not practical when using MANTA. Additional high-powered studies are required to determine the safety and efficacy of MANTA device.

Endocarditis infecciosa con compromiso bivalvular por Erysipelothrix rhusiopathiae / Infective endocarditis with bivalvular involvement due to Erysipelothrix rhusiopathiae. Report of one case

The microbiology of infective endocarditis (IE) varies in different populations and depends on public health conditions and socioeconomic status. In low-income countries, oral Streptococci affect hearts with rheumatic valve disease in patients with poor dentition. In high-income countries, Staphylococci are the most common cause, affecting elderly and immunocompromised patients, or those with invasive devices. Gram - positive bacili as IE pathogens are unusual. Erysipelothrix rhusiopathiae is a Gram positive bacili. It causes skin diseases in domestic and farm animals, but in humans, is a very unusual pathogen. This infection is considered a zoonosis, since most cases are linked to direct contact with vector animals. We report a 62 year-old male patient with a history of exposure to animals, who developed an infective endocarditis with severe bivalve regurgitation and septic shock, requiring antimicrobials and surgical resolution. Erysipelothrix rhusiopathiae was isolated from blood and valve vegetation cultures. The patient had a successful evolution and was discharged from the hospital.

HAS-BLED Score for Prediction of Bleeding and Mortality After Transcatheter Aortic Valve Replacement

ABSTRACT Introduction: Bleeding after transcatheter aortic valve replacement (TAVR) is associated with increased mortality. The predictive value of the HAS-BLED score in TAVR patients is still to be evaluated. We assessed the value of the HAS-BLED score to predict in-hospital bleeding and mortality after TAVR and the impact of diferent renal impairment definitions on the predictive value of the score system. Methods: We retrospectively included 574 patients who underwent TAVR at a single center. Study outcomes were 30-day mortality and the composite endpoint of major and life-threatening bleeding as defined by The Valve Academic Research Consortium-2. The predictive value of the HAS-BLED score was calculated and compared to a modified model. The performance of the score was compared using two definitions of renal impairment. Model discrimination was tested using C-statistic and the Net Reclassification Index. Results: Bleeding occurred in 78 patients (13.59%). HAS-BLED category 3 was a significant predictor of bleeding (OR: 1.99 ]1.18- 3.37], C-index: 0.56, P=0.01). C-index increased to 0.64 after adding body surface area and extracardiac arteriopathy to the model. The Net Reclassification Index showed an increase in the predic tive value of the model by 11.4% (P=0.002). The C-index increased to 0.61 using renal impairment definition based on creatinine clearance. Operative mortality was significantly associated with the HAS-BLED score (OR: 7.54 [95% CI: 2.73- 20.82], C-index: 0.73, P<0.001). Conclusion: The HAS-BLED score could be a good predictor of in-hospital mortality after TAVR. Its predictive value for bleeding was poor but improved by adding procedure-specific factors and using creatinine clearance to define renal impairment.

Comparison of Outcomes After Transcatheter Versus Surgical Repeat Mitral Valve Replacement

ABSTRACT Introduction: Repeat transcatheter mitral valve replacement (rTMVR) has emerged as a new option for the management of high-risk patients unsuitable for repeat surgical mitral valve replacement (rSMVR). The aim of this study was to compare hospital outcomes, survival, and reoperations after rTMVR versus surgical mitral valve replacement. Methods: We compared patients who underwent rTMVR (n=22) from 2017 to 2019 (Group 1) to patients who underwent rSMVR (n=98) with or without tricuspid valve surgery from 2009 to 2019 (Group 2). We excluded patients who underwent a concomitant transcatheter aortic valve replacement or other concomitant surgery. Results: Patients in Group 1 were significantly older (72.5 [67-78] vs. 57 [52-64] years, P<0.001). There was no diference in EuroSCORE II between groups (6.56 [5.47-8.04] vs. 6.74 [4.28-11.84], P=0.86). Implanted valve size was 26 (26-29) mm in Group 1 and 25 (25-27) mm in Group 2 (P=0.106). There was no diference in operative mortality between groups (P=0.46). However, intensive care unit (ICU) and hospital stays were shorter in Group 1 (P=0.03 and <0.001, respectively). NYHA class improved significantly in both groups at one year (P<0.001 for both groups). There was no group effect on survival (P=0.84) or cardiac readmission (P=0.26). However, reoperations were more frequent in Group 1 (P=0.01). Conclusion: Transcatheter mitral valve-in-valve could shorten ICU and hospital stay compared to rSMVR with a comparable mortality rate. rTMVR is a safe procedure; however, it has a higher risk of reoperation. rTMVR can be an option in selected high-risk patients.

Contrast-zero ultrasound-guided transcatheter aortic valve replacement: A case report / 中国胸心血管外科临床杂志

@#Conventional transcatheter aortic valve replacement is normally recommended with transthoracic echocardiography, and contrast agent mediated fluoroscopy under anesthesia to guide a better implantation of the transcatheter valve. However, iodine-containing contrast agent possibly damages the patient’s kidney, and even induces the acute kidney injury. We reported a 75-year-old patient diagnosed with severe aortic valve stenosis, moderate regurgitation, and chronic renal failure. We performed the aortic valve replacement under the guidance of fluoroscopy and transesophageal ultrasound without contrast agent. Seven days after surgery, the patient recovered well and discharged with alleviated aortic stenosis and fixed transcatheter aortic valve.

Effectiveness and safety of transcatheter aortic valve replacement in treatment of aortic regurgitation: A systematic review and meta-analysis / 中国胸心血管外科临床杂志

@#Objective    To investigate effectiveness and safety of transcatheter aortic valve replacement in the treatment of aortic regurgitation. Methods     PubMed, EMbase, The Cochrane Library, Web of Science, CNKI, Wanfang Data and VIP were searched from inception to August 2021. According to the criteria of inclusion and exclusion, two reviewers independently screened the literature, extracted the data and evaluated the quality of the included studies. Then, Stata 16.0 software was used for meta-analysis. Subgroup meta-analysis of valve type used and study type was performed. Results    Twenty-five studies (12 cohort studies and 13 single-arm studies) were included with 4 370 patients. Meta-analysis results showed that an incidence of device success was 87% (95%CI 0.81-0.92). The success rate of the new generation valve subgroup was 93% (95%CI 0.89-0.96), and the early generation valve subgroup was 66% (95%CI 0.56-0.75). In addition, the 30-day all-cause mortality was 7% (95%CI 0.05-0.10), the 30-day cardiac mortality was 4% (95%CI 0.01-0.07), the incidence of pacemaker implantation was 10% (95%CI 0.08-0.13), and the incidence of conversion to thoraco-tomy was 2% (95%CI 0.01-0.04). The incidence of moderate or higher paravalvular aortic regurgitation was 6% (95%CI  0.03-0.09). Conclusion     Transcatheter aortic valve replacement for aortic regurgitation is safe and yields good results, but some limitations can not be overcome. Therefore, multicenter randomized controlled trials are needed to confirm our results.

Transcatheter aortic valve implantation for native aortic valve regurgitation: A systematic review and meta-analysis / 中国胸心血管外科临床杂志

@#Objective     To evaluate the efficacy of transcatheter aortic valve implantation (TAVI) for native aortic valve regurgitation. Methods    Literature from The Cochrane Library, PubMed, EMbase, Cochrane Controlled Trials Registry, ClinicalTrials.gov and China Biomedical Literature Database from January 2002 to May 2021 were searched by computer. The literature on TAVI or transcatheter aortic valve replacement treatment for simple aortic reflux were collected. Two reviewers independently screened the literature according to the inclusion and exclusion criteria, extracted data, and assessed the quality of the literature. Meta-analysis was performed using STATA 14.0 software. Results    A total of 15 studies including 1 394 patients were included. The Newcastle-Ottawa Scales of the studies were≥6 points. The success rate of prosthetic valve implantation was 72.0%-100.0%, and there was no report of serious complications such as surgical death, myocardial infarction, and valve annulus rupture. The 30-day all-cause mortality rate was 6.3% [95%CI (3.4%, 9.1%)]. The incidence of stroke within 30 days and the rate of postoperative permanent pacemaker implantation were 2.0% [95%CI (1.0%, 4.0%)] and 6.0% [95%CI (4.0%, 10.0%)], respectively, and were both within acceptable limits. Conclusion    For patients with simple high-risk aortic regurgitation, TAVI can obtain satisfactory treatment effects and has low postoperative complications rate, and it may be a potential treatment option for such patients.

Preliminary clinical outcomes of the domestic Renatus® balloon-expandable valve system for the treatment of severe aortic stenosis: A prospective cohort study / 中国胸心血管外科临床杂志

@#Objective     To evaluate the early clinical outcomes of the Renatus® balloon-expandable valve in the treatment of severe aortic stenosis. Methods    From November 2021 to April 2022, a total of 38 patients who received Renatus® balloon-expandable valve for severe aortic stenosis in Guangdong Provincial People's Hospital were included. There were 22 males and 16 females, with an average age of 73.7±5.3 years. Mean aortic gradient and peak aortic jet velocity at baseline, post-procedure, and follow-up were compared. Clinical outcomes including all-cause mortality, perivalvular leakage, serious adverse cardiovascular events and the occurrence of permanent pacemaker implantation were assessed. Results    All patients completed the procedure successfully without conversion to thoracotomy or perioperative death. The post-implant mean aortic pressure gradient was decreased from 41.5 (27.8, 58.8) mm Hg to 6.0 (3.0, 8.0) mm Hg, and the peak aortic jet velocity was also decreased from 4.1±0.9 m/s to 1.7±0.4 m/s (P<0.001). Pacemakers were required in 2 (5.3%) patients. The median follow-up time was 27.5 (23.0, 87.5) d, with a follow-up rate of 100.0%. The mean aortic gradient was 8.0 (7.0, 10.8) mm Hg and peak aortic jet velocity was 2.0±0.3 m/s, showing significant improvement compared with those in the preoperative period (P<0.001). No severe aortic regurgitation or paravalvular leak was observed. There was no serious cardiovascular adverse event or reoperative event during the study period. Conclusion    Transcatheter aortic valve replacement with the domestic Renatus® balloon-expandable valve system is a safe and effective procedure for selected patients with severe aortic stenosis who are at high risk or not candidates for surgical aortic valve replacement.

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.

Insuficiência Tricúspide e Mortalidade em Pacientes Submetidos à Troca da Valva Aórtica Transcateter: Uma Revisão Sistemática e Metanálise / Tricuspid Regurgitation and Mortality in Patients Undergoing Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis

Resumo Fundamento A extensão do dano cardíaco associada à estenose aórtica tem importantes implicações prognósticas após a substituição da valva aórtica transcateter (TAVR). Contudo, ainda não está claro qual é o papel da insuficiência tricúspide (IT) nesse cenário clínico. Objetivos Explorar a associação entre IT e mortalidade em pacientes submetidos a TAVR e avaliar as alterações na gravidade da IT após a TAVR e sua relação com mortalidade de curto e médio prazo. Métodos Foram feitas pesquisas em bases de dados relevantes de artigos publicados do início até agosto de 2020. Dos 414 estudos triados, selecionamos 24 que relataram o grau de IT pré- ou pós-TAVR. O desfecho primário foi mortalidade por todas as causas, e foram conduzidos modelos de metanálise de efeitos aleatórios (a um nível de significância de 5%). Resultados Dezessete estudos relataram associações entre IT pré-TAVR e mortalidade por todas as causas (> 45.000 participantes), e 13 avaliaram a gravidade da IT pós-TAVR (709 participantes). A IT basal moderada/grave foi associada a maior mortalidade por todas as causas em 30 dias [razão de risco (RR) 1,65; intervalo de confiança (IC) 95% 1,20-2,29] e 1,2 ano (RR 1,56; IC95% 1,31-1,84). Após a TAVR, 43% dos pacientes apresentaram redução de pelo menos um grau na IT (30 dias, IC95% 30-56%), que se sustentou em 12,5 meses em 44% dos participantes (IC95% 35-52%).A persistência de IT significativa foi associada a um aumento de duas vezes na mortalidade por todas as causas (RR 2,12; IC95% 1,53-2,92). Conclusões A IT significativa pré-TAVR está associada a maior mortalidade. Ainda que a gravidade da IT possa melhorar, a persistência de IT significativa após a TAVR está fortemente associada ao aumento da mortalidade. Nossos achados destacam a importância de uma avaliação detalhada da IT pré- e pós-TAVR e podem ajudar a identificar pacientes que possam se beneficiar de uma vigilância mais cuidadosa nesse cenário.

Abstract Background The extent of cardiac damage associated with aortic stenosis has important prognostic implications after transcatheter aortic valve replacement (TAVR). However, the role of tricuspid regurgitation (TR) in this clinical setting is still unclear. Objectives To explore the association between TR and mortality in patients undergoing TAVR and assess changes in TR severity post TAVR and its relationship with short and mid-term mortality. Methods Relevant databases were searched for articles published from inception until August 2020. Out of 414 screened studies, we selected 24 that reported the degree of TR pre or post TAVR. The primary outcome was all-cause mortality, and random effects meta-analysis models were conducted (at a significance level of 5%). Results Seventeen studies reported associations between pre-TAVR TR and all-cause mortality (> 45,000 participants) and thirteen accessed TR severity post TAVR (709 participants). Moderate/severe baseline TR was associated to higher all-cause mortality both at 30 days (HR 1.65; 95% CI, 1.20-2.29) and 1.2 years (HR 1.56; 95% CI, 1.31-1.84). After TAVR, 43% of patients presented a decrease of at least one grade in TR (30 days, 95% CI, 30-56%), sustained at 12.5 months in 44% of participants (95% CI, 35-52%). Persistence of significant TR was associated with a two-fold increase in all-cause mortality (HR 2.12; 95% CI, 1.53-2.92). Conclusions Significant TR pre TAVR is associated with higher mortality. Although TR severity may improve, the persistence of significant TR post TAVR is strongly associated with increased mortality. Our findings highlight the importance of a detailed assessment of TR pre and post TAVR and might help identify patients who may benefit from more careful surveillance in this scenario.

Reparo valvar percutâneo borda a borda da insuficiência mitral após implante transcateter de válvula aórtica / Percutaneous edge-to-edge mitral regurgitation valve repair after transcatheter aortic valve implantation

A insuficiência mitral moderada a grave é observada em 17 a 35% dos pacientes submetidos a implante transcateter de válvula aórtica. Estudo que reporta a insuficiência mitral pós- realização de implante transcateter de válvula aórtica por estenose aórtica demonstra que 50% dos pacientes com refluxo moderado a grave apresentaram melhora da regurgitação, e 8,7% evidenciam piora do quadro. Nesses pacientes com piora, houve aumento da mortalidade. Essa progressão sugere que condutas convencionais, baseadas em otimização medicamentosa, podem não ser capazes de prevenir quadros negativos. Relatamos um caso sobre a evolução da insuficiência mitral após implante transcateter de válvula aórtica e o uso do MitraClip® como alternativa de tratamento e benefícios.

Moderate to severe mitral regurgitation is observed in 17 to 35% of patients undergoing transcatheter aortic valve implantation. A study reporting mitral regurgitation after transcatheter aortic valve implantation due to aortic stenosis demontrated 50% of patients with moderate to severe reflux showed improvement in regurgitation, and 8.7% showed worsening of the condition, which led to increased mortality. This progression suggested conventional management, based on medication optimization, may not be able to prevent poor outcomes. We report a case on the clinical course of a patient with mitral regurgitation after transcatheter aortic valve implantation, and the use of MitraClip® as an alternative treatment and its benefits.

Implante Valvar Transcateter em Pacientes com Estenose Valvar Aórtica: Uma Overview de Revisões Sistemáticas e Metanálise Incluindo Múltiplas Populações / Transcatheter Valve Replacement in Patients with Aortic Valve Stenosis: An Overview of Systematic Reviews and Meta-Analysis with Different Populations

Resumo Fundamento Ensaios clínicos randomizados (ECRs) e estudos observacionais compararam a eficácia e a segurança do implante valvar transcateter (TAVR) e da substituição cirúrgica da valva aórtica (SAVR) em pacientes com estenose aórtica grave. Objetivos Comparar TAVR e SAVR em pacientes com diferentes riscos cirúrgicos, características da população e diferentes válvulas protéticas transcateter. Métodos Uma overview das revisões sistemáticas (RSs) foi realizada seguindo um protocolo estruturado. Os resultados foram agrupados por risco cirúrgico, características da população e diferentes válvulas. Os ECRs foram reanalisados por meio de metanálises nas RSs, e os resultados foram resumidos por meio do método GRADE. O nível de significância estatística adotado foi de 5%. Resultados Em comparação com a SAVR, os pacientes com alto risco cirúrgico submetidos à TAVR tiveram um risco menor de ( odds ratio , intervalo de confiança de 95%, diferença absoluta de risco) fibrilação atrial (FA) (0,5, 0,29-0,86, -106/1000) e hemorragia com risco à vida (0,29, 0,2-0,42, -215/1000). Pacientes com risco cirúrgico intermediário apresentaram menor risco de FA (0,27, 0,23-0,33, -255/1.000), hemorragia com risco à vida (0,15, 0,12-0,19, -330/1.000) e insuficiência renal aguda (IRA) (0,4, 0,26-0,62, -21/1000). Pacientes com baixo risco cirúrgico tiveram menor risco de morte (0,58, 0,34-0,97, -16/1000), acidente vascular encefálico (AVE) (0,51, 0,28-0,94, -15/1000), FA (0,16, 0,12-0,2, -295/1000), hemorragia com risco à vida (0,17, 0,05-0,55, -76/1000) e IRA (0,27, 0,13-0,55, -21/1000) e tiveram maior risco de implante de marca-passo definitivo (IMD) (4,22, 1,27 -14.02, 141/1000). Os dispositivos de geração mais recente tiveram um risco menor de FA em comparação com as gerações mais antigas, e pacientes usuários de dispositivos expansíveis por balão não apresentaram riscos maiores de IMD. Conclusões Este artigo apresenta evidências de que pacientes com risco cirúrgico baixo, intermediário e alto apresentam melhores desfechos quando tratados com TAVR em comparação com a SAVR.

Abstract Background Randomized controlled trials (RCTs) and observational studies have compared the efficacy and safety of transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis. Objectives Compare TAVR and SAVR in patients with different surgical risks, population characteristics, and different transcatheter prosthetic valves. Methods An overview of systematic reviews (SRs) was conducted following a structured protocol. Results were grouped by surgical risk, population characteristics, and different valves. RCTs in the SRs were reanalyzed through meta-analyses, and the results were summarized using the GRADE method. The adopted level of statistical significance was 5%. Results Compared to SAVR, patients with high surgical risk using TAVR had a lower risk of (odds ratio, 95% confidence interval, absolute risk difference) atrial fibrillation (AF) (0.5, 0.29-0.86, -106/1000) and life-threatening bleeding (0.29, 0.2-0.42, -215/1000). Patients with intermediate surgical risk had a lower risk of AF (0.27, 0.23-0.33, -255/1000), life-threatening bleeding (0.15, 0.12-0.19, -330/1000), and acute renal failure (ARF) (0.4, 0.26-0.62, -21/1000). Patients with low surgical risk had a lower risk of death (0.58, 0.34-0.97, -16/1000), stroke (0.51, 0.28-0.94, -15/1000), AF (0.16, 0.12-0.2, -295/1000), life-threatening bleeding (0.17, 0.05-0.55, -76/1000), and ARF (0.27, 0.13-0.55, -21/1000), and had a higher risk of permanent pacemaker implantation (PPI) (4.22, 1.27-14.02, 141/1000). Newer generation devices had a lower risk of AF than older generations, and patients using balloon-expandable devices did not experience higher risks of PPI. Conclusions This paper provides evidence that patients at low, intermediate, and high surgical risks have better outcomes when treated with TAVR compared with SAVR.