Mid- to long-term clinical and echocardiographic outcomes after transcatheter aortic valve replacement with a newgeneration, self-expandable system / Desfechos clínicos e ecocardiográficos de médio a longo prazo após a substituição da válvula aórtica transcateter com uma nova geração, sistema auto-expansível

Abstract Objectives: The aim of the study was to evaluate mid- to late clinical and echocardiographic outcomes after transcatheter aortic valve replacement (TAVR) with A curate neo™ (Boston Scientific, Boston, MA). Background: TAVR is an established treatment for aortic stenosis (AS). Few data exist on mid- to long-term outcomes and durability after new-generation valves. Methods: All consecutive patients (n = 104) who underwent A curate neo™ implantation from 2012 to 2018 were included. Follow-up was systematically performed at 1, 6, 12, and 24 months and yearly thereafter. Outcomes were reported according to VARC-2, and structural valve deterioration (SVD) or bioprosthetic valve failure defined accordingly to new definitions. Results: Mean age was 82 ± 5.4 years, 56.7% were female and the Society of Thoracic Surgeons score for mortality was 5.9 ± 4%. Patients were followed for a median of 3 years (1,092 days; IQR 1.5­4 years), and the maximum follow-up was 7 years. All-cause mortality values at 1 and 5 years were 8.5% and 40.5%, respectively. No relevant changes in mean gradient and orifice area occurred (7.9 ± 3.8 mmHg and 1.9 ± 0.3 cm2 at 1 year; 6.6 ± 2.1 mmHg and 1.8 ± 0.3 cm2 at 5 years), and there was a significant rate of paravalvular leaks resolution at 1, 2, and 3 years (p = .004; p < .001; p < .001, respectively). None of the patients had leaflet thrombosis or endocarditis. One patient developed SVD at 84 months. Conclusions: A curate neo™ was associated with sustained echocardiographic results. Reassuring mid- to long-term outcomes was observed in this cohort of elderly patients with severe AS.

Predictive role of Selvester QRS score in patients undergoing transcatheter aortic valve replacement

INTRODUCTION: Few data exist regarding the late clinical impact of the Selvester score prediction of myocardial fibrosis after transcatheter aortic valve replacement (TAVR). This study evaluated the predictive power of the Selvester score on survival in patients with aortic stenosis (AS) undergoing TAVR. METHODS And Results: Patients with severe AS who had preoperative electrocardiograms were included. Clinical follow-up was obtained retrospectively. The primary endpoint was all-cause mortality. Secondary endpoints were cardiovascular death and major adverse cardiac events (MACEs). Two-hundred twenty-eight patients were included (mean age, 81.5 ± 7.4 years; women, 58.3%). Deceased patients had a higher mean score (4.6 ± 3.2 vs. 1.4 ± 1.3; p < .001). At a mean follow-up of 36.2 ± 21.2 months, the Selvester score was independently associated with all-cause mortality (hazard ratio [HR], 1.65; 95% confidence interval [CI], 1.48-1.84; p < .001), cardiovascular death (HR, 1.59; 95% CI, 1.38-1.74; p < .001), and MACE (HR, 1.55; 95% CI, 1.30-1.68; p < .001). After 5 years, the mortality risk was incrementally related to the Selvester score. The involvement of the inferior wall of the left ventricle was a lower mortality risk factor (HR, 0.42; 95% CI, 0.18-0.98; p = .046). For a Selvester score of 3, the area under the curve showed 0.92, 0.94, and 0.86 (p < .001), respectively, for 1, 2, and 3 years. CONCLUSIONS: Elevated Selvester scores increase the risk of poor outcomes in patients with AS undergoing TAVR. The involvement of the anterior or lateral wall presents worse prognosis.

Hemodynamic and imaging assessment of transcatheter aortic valve replacement with the inovare® proseal using multislice computed tomography

Abstract Objective: To evaluate the hemodynamic performance (i.e., gradients and paravalvular leakage [PVL]) of the new and experimental Braile Inovare® Proseal. Additionally, we aimed to assess pre and postoperatively the aortic annulus and the transcatheter prosthesis using multislice computed tomography (MSCT). Methods: Patients were selected by a multidisciplinary heart team and referred for transcatheter aortic valve replacement (TAVR). MSCT was performed before and after surgery. Measurements of the aortic valve and prosthesis were conducted and correlated with the valve gradient and residual PVL. Results: Twenty-one patients were selected for the protocol. Patients had a mean age of 79 years and 38% of them were of female sex. The mean EuroSCORE II value was 12.5%±10.8. Mean gradient was reduced from 45.8±11.04 mmHg to 5.59±2.61 mmHg and there were no instances of PVL worse than mild. There were no cases of coronary obstruction or procedural death. Circularity was present in all prostheses evaluated. Circularity indexes for the prostheses were: inflow 0.05±0.03, middle third 0.04±0.02, and outflow 0.04±0.02 (P=0.08). The mean distance between the prosthesis and the left and right coronary ostia were 14.8 mm±3.3 and 17.3 mm±3, respectively. Oversizing was appropriate with a mean of 22.14%±6%. Conclusion: Braile Inovare® Proseal transcatheter device has demonstrated low gradients with low rates of PVL. Oversizing by annular measurements was adequate. MSCT was adequate to evaluate device sizing and has demonstrated preserved expansibility and circularity in the evaluated cases.

Current generation balloon-expandable transcatheter valve positioning strategies during aortic valve-in-valve procedures and clinical outcomes

OBJECTIVES: This study sought to evaluate SAPIEN 3 (S3) (Edwards Lifesciences, Irvine, California) positioning using different strategies. BACKGROUND: Aortic valve-in-valve (ViV) is associated with high risk of elevated gradients. METHODS: S3 aortic ViV procedures in stented bioprostheses were studied. Transcatheter heart valve (THV) positioning was analyzed in a centralized core lab blinded to clinical outcomes. A combined endpoint of severely elevated mean gradient ($30 mm Hg) or pacemaker need was established. Two positioning strategies were compared: central marker method and top of S3 method. Optimal final depth was defined as S3 depth #20%. RESULTS: A total of 113 patients met inclusion criteria and were analyzed (76.5 _ 9.7 years of age, 65.8% male, STS score 8 _ 7.6%). THVs had incomplete shortening in comparison to fully expanded valves (92 _ 3.4%), and expansion was more complete in optimal positioning cases compared with others (93.2 _ 2.7% vs. 91.5 _ 3.5%; p » 0.027). The central marker method demonstrated greater correlation with final implantation depth than the top of S3 method (R2 of 0.48 and 0.14; p < 0.001 and p » 0.001, respectively). The combined endpoint rate was 4.3% in the optimal (higher than 3 mm) implantation group, 12% in the intermediate group, and 50% in the low group (p < 0.001). There were no cases of THV embolization. In cases with central marker higher than 3 mm, 72.4% had optimal final depth. In those with central marker higher than 6 mm, 90% had optimal final depth. CONCLUSIONS: Optimal S3 positioning in aortic ViV is associated with better outcomes. Central marker positioning is more reliable than top of S3 positioning. Central marker bottom position should be 3 mm to 6 mm above the ring. (AU)

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

Standardized definition of structural valve degeneration for surgical and transcatheter bioprosthetic aortic valves

ABSTRACT: Bioprostheses are prone to structural valve degeneration, resulting in limited long-term durability. A significant challenge when comparing the durability of different types of bioprostheses is the lack of a standardized terminology for the definition of a degenerated valve. This issue becomes especially important when we try to compare the degeneration rate of surgically inserted and transcatheter bioprosthetic valves. This document, by the VIVID (Valve-in-Valve International Data), proposes practical and standardized definitions of valve degeneration and provides recommendations for the timing of clinical and imaging follow-up assessments accordingly. Its goal is to improve the quality of research and clinical care for patients with deteriorated bioprostheses by providing objective and strict criteria that can be utilized in future clinical trials. We hope that the adoption of these criteria by both the cardiological and surgical communities will lead to improved comparability and interpretation of durability analyses.