Concordance between vessel-specific and vascular territory coronary functional assessment: A comparison of quantitative flow ratio and myocardial perfusion scintigraphy.

BACKGROUND: Quantitative flow ratio (QFR) and myocardial perfusion scintigraphy (MPS) are utilized for assessing coronary artery disease (CAD) significance. We aimed to analyze their concordance and prognostic impact. AIMS: We aimed to analyze the concordance between QFR and MPS and their risk stratification. METHODS: Patients with invasive coronary angiography and MPS were categorized as concordant if QFR ≤ 0.80 and summed difference score (SDS) ≥ 4 or if QFR > 0.80 and SDS < 4; otherwise, they were discordant. Concordance was classified by coronary territory involvement: total (three territories), partial (two territories), poor (one territory), and total discordance (zero territories). Leaman score assessed coronary atherosclerotic burden. RESULTS: 2010 coronary territories (670 patients) underwent joint QFR and MPS analysis. MPS area under the curve for QFR ≤ 0.80 was 0.637. Concordance rates were total (52.5%), partial (29.1%), poor (15.8%), and total discordance (2.6%). Most concordance occurred in patients without significant CAD or with single-vessel disease (89.5%), particularly without MPS perfusion defects (91.5%). Leaman score (odds ratio [OR]: 0.839, 95% confidence interval [CI]: 0.805-0.875, p < 0.001) and MPS perfusion defect (summed stress score [SSS] ≥ 4) (OR: 0.355, 95% CI: 0.211-0.596, p < 0.001) were independent predictors for discordance. After 1400 days, no significant difference in death/myocardial infarction was observed based on MPS assessment, but Leaman score, functional Leaman score, and average QFR identified higher risk patients. CONCLUSIONS: MPS showed good overall accuracy in assessing QFR significance but substantial discordance existed. Predictors for discordance included higher atherosclerotic burden and MPS perfusion defects (SSS ≥ 4). Leaman score, QFR-based functional Leaman score, and average QFR provided better risk stratification for all-cause death and myocardial infarction than MPS.

Final 36-Month Outcomes from the Multicenter DynamX Study Evaluating a Novel Thin-Strut Novolimus-Eluting Coronary Bioadaptor System and Supporting Preclinical Data.

Background: The DynamX Novolimus-Eluting Coronary Bioadaptor System ( DynamX ® Bioadaptor) has uncaging elements that disengage after the resorption of the polymer coating, aiming to restore vessel function in the treated segment and to avoid long-term adverse outcomes associated with the permanent caging of the coronary artery seen with conventional stenting. Methods: This prospective, multicenter, single-arm first-in-human study enrolled 50 patients in Belgium and Italy who were treated with the DynamX Bioadaptor. Eligible patients had de novo lesions in coronary arteries measuring between 2.5 and 3.5 mm in diameter and ≤ 24 mm in length. Clinical follow-up was performed up to 36 months. This analysis includes the intention-to-treat population and is based on data available. The preclinical studies include optical coherence tomography (OCT) analyses of 5 DynamX Bioadaptors implanted in 3 mini Yucatan pigs (at 3, 12 and 24 months), and assessment of smooth muscle cell gene expression profile in 8 pigs of which each was implanted with the DynamX Bioadaptor and the Xience drug-eluting stent. To assess the gene expression profile by quantitative real-time polymerase chain reaction, animals were sacrificed at 3, 6, 9 and 12 months. Results: Target lesion failure at 36 months was 8.7% (4/46), consisting of one clinically-driven target lesion revascularization and 3 cardiac deaths (all site-reported to be unrelated to the device or procedure). There were no additional target vessel revascularization and no definite or probable scaffold thrombosis. Preclinical data confirmed late lumen enlargement (from 7.02 ± 1.31 mm 2 at baseline to 8.46 ± 1.31 mm 2 at 24 months) and identified an increased expression of contractile genes around 9 months compared to a conventional drug-eluting stent. Conclusions: The DynamX Bioadaptor demonstrated very good 36-month clinical outcomes, highlighted by the absence of target-vessel myocardial infarction and definite or probable device thrombosis, and only one target lesion revascularization up to 36 months. These data are supported by preclinical studies that showed late lumen enlargement by OCT and an increased expression of contractile genes around 9 months compared to conventional drug-eluting stents, indicating faster vessel healing. Larger clinical studies are necessary to compare outcomes against contemporary drug-eluting stents. Clinical Trial Registration: https://clinicaltrials.gov/: NCT03429894.

Risk Burden of Cancer in Patients Treated With Abbreviated Dual Antiplatelet Therapy After PCI: Analysis of Multicenter Controlled High-Bleeding Risk Trials.

BACKGROUND: Oncological patients with coronary artery disease face an elevated risk of hemorrhagic and ischemic events following percutaneous coronary intervention. Despite medical guidelines recommending minimal dual antiplatelet therapy (DAPT) duration for patients with cancer, dedicated data on abbreviated DAPT in this population is lacking. This study aims to evaluate the occurrence of ischemic and hemorrhagic events in patients with cancer compared with other high-bleeding risk individuals. METHODS: Patient-level data from 4 high-bleeding risk coronary drug-eluting stent studies (ONYX One, LEADERS FREE, LEADERS FREE II, and SENIOR trials) treated with short DAPT were analyzed. The comparison focused on patients with high-bleeding risk with and without cancer, assessing 1-year rates of net adverse clinical events (all-cause death, myocardial infarction, stroke, revascularization, and Bleeding Academic Research Consortium [BARC] types 3 to 5 bleeding) and major adverse clinical events (all-cause death, myocardial infarction, stroke). RESULTS: A total of 5232 patients were included, of whom 574 individuals had cancer, and 4658 were at high-bleeding risk without previous cancer. Despite being younger with fewer risk factors, patients with cancer had higher net adverse clinical event (HR, 1.25; P=0.01) and major adverse clinical event (HR, 1.26; P=0.02), primarily driven by all-cause mortality and major bleeding (BARC 3-5), but not myocardial infarction, stroke, stent thrombosis, or repeat revascularization. Cancer was an independent predictor of net adverse clinical event (P=0.005), major adverse clinical event (P=0.01), and major bleeding (P=0.03). CONCLUSIONS: The present work is the first report on abbreviated DAPT dedicated to patients with cancer. Cancer is a major marker of adverse outcomes and these events had high lethality. Despite short DAPT, patients with cancer experienced higher rates of major bleeding compared with patients without cancer with high-bleeding risk, which occurred mainly after DAPT discontinuation. These findings reinforce the need for a more detailed and individualized stratification of those patients. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT03344653, NCT01623180, NCT02843633, NCT0284.

Myocardial Injury After Transcatheter Mitral Valve Replacement Versus Surgical Reoperation.

This study aimed to evaluate the incidence and clinical implications of myocardial injury, as determined by cardiac biomarker increase, in patients who underwent mitral bioprosthesis dysfunction treatment with transcatheter mitral valve replacement (TMVR) versus surgical mitral valve replacement reoperation (SMVR-REDO). Between 2014 and 2023, 310 patients with mitral bioprosthesis failure were included (90 and 220 patients for TMVR and SMVR-REDO, respectively). Multivariable analysis and propensity score matching were performed to adjust for the intergroup differences in baseline characteristics. Creatinine kinase-MB (CK-MB) and cardiac troponin I (cTn) were collected at baseline and 6 to 12, 24, 48, and 72 hours after intervention. The cardiac biomarkers values were evaluated in relation to their reference values. The outcomes were determined according to the Mitral Valve Academic Research Consortium criteria. CK-MB and cTn increased above the reference level in almost all patients after SMVR-REDO and TMVR (100% vs 94%, respectively), with the peak occurring within 6 to 12 hours. SMVR-REDO was associated with a two- to threefold higher increase in cardiac biomarkers. After 30 days, the mortality rates were 13.3% in the TMVR and 16.8% in the SMVR-REDO groups. At a median follow-up of 19 months, the mortality rates were 21.1% in the TMVR and 17.7% in the SMVR-REDO groups. Left ventricular ejection fraction, estimated glomerular filtration rate, CK-MB, and cTn were predictors of mortality. In conclusion, some degree of myocardial injury occurred systematically after the treatment of mitral bioprosthetic degeneration, especially after SMVR, and higher CK-MB and cTn levels were associated with increased cumulative late mortality, regardless of the approach.

One-Year Outcomes of Transseptal Mitral Valve-in-Valve in Intermediate Surgical Risk Patients.

BACKGROUND: Transcatheter mitral valve-in-valve replacement offers a less-invasive alternative for high-risk patients with bioprosthetic valve failure. Limited experience exists in intermediate-risk patients. We aim to evaluate 1-year outcomes of the PARTNER 3 mitral valve-in-valve study. METHODS: This prospective, single-arm, multicenter study enrolled symptomatic patients with a failing mitral bioprosthesis demonstrating greater than or equal to moderate stenosis and regurgitation and Society of Thoracic Surgeons score ≥3% and <8%. A balloon-expandable transcatheter heart valve (SAPIEN 3, Edwards Lifesciences) was used via a transeptal approach. The primary end point was the composite of all-cause mortality and stroke at 1 year. RESULTS: A total of 50 patients from 12 sites underwent mitral valve-in-valve from 2018 to 2021. The mean age was 70.1±9.7 years, mean Society of Thoracic Surgeons score was 4.1%±1.6%, and 54% were female. There were no primary end point events (mortality or stroke) through 1 year, and no left-ventricular outflow tract obstruction, endocarditis, or mitral valve reintervention was reported. Six patients (12%) required rehospitalization, including heart failure (n=2), minor procedural side effects (n=2), and valve thrombosis (n=2; both resolved with anticoagulation). An additional valve thrombosis was associated with no significant clinical sequelae. From baseline to 1 year, all subjects with available data had none/trace or mild (grade 1+) mitral regurgitation and the New York Heart Association class improved in 87.2% (41/47) of patients. CONCLUSIONS: Mitral valve-in-valve with a balloon-expandable valve via transseptal approach in intermediate-risk patients was associated with improved symptoms and quality of life, adequate transcatheter valve performance, and no mortality or stroke at 1-year follow-up. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03193801.

Learning Curve for In-Hospital Mortality of Transcatheter Aortic Valve Replacement: Insights from the Brazilian National Registry. / Curva de Aprendizagem da Mortalidade Hospitalar da Substituição da Válvula Aórtica Transcateter: Insights do Registro Nacional Brasileiro.

BACKGROUND: Robust data on the learning curve (LC) of transcatheter aortic valve replacement (TAVR) are lacking in developing countries. OBJECTIVE: To assess TAVR's LC in Brazil over time. METHODS: We analyzed data from the Brazilian TAVR registry from 2008 to 2023. Patients from each center were numbered chronologically in case sequence numbers (CSNs). LC was performed using restricted cubic splines adjusted for EuroSCORE-II and the use of new-generation prostheses. Also, in-hospital outcomes were compared between groups defined according to the level of experience based on the CSN: 1st to 40th (initial-experience), 41st to 80th (early-experience), 81st to 120th (intermediate-experience), and over 121st (high-experience). Additional analysis was performed grouping hospitals according to the number of cases treated before 2014 (>40 and ≤40 procedures). The level of significance adopted was <0.05. RESULTS: A total of 3,194 patients from 25 centers were included. Mean age and EuroSCORE II were 80.7±8.1 years and 7±7.1, respectively. LC analysis demonstrated a drop in adjusted in-hospital mortality after treating 40 patients. A leveling off of the curve was observed after case #118. In-hospital mortality across the groups was 8.6%, 7.7%, 5.9%, and 3.7% for initial-, early-, intermediate-, and high-experience, respectively (p<0.001). High experience independently predicted lower mortality (OR 0.57, p=0.013 vs. initial experience). Low-volume centers before 2014 showed no significant decrease in the likelihood of death with gained experience, whereas high-volume centers had a continuous improvement after case #10. CONCLUSION: A TAVR LC phenomenon was observed for in-hospital mortality in Brazil. This effect was more pronounced in centers that treated their first 40 cases before 2014 than those that reached this milestone after 2014.

Percutaneous Strategies in Structural Heart Diseases: Focus on Chronic Heart Failure. / Estratégias Percutâneas em Doenças Estruturais: Foco em Insuficiência Cardíaca Crônica.

BACKGROUND: Central Illustration : Percutaneous Strategies in Structural Heart Diseases: Focus on Chronic Heart Failure Transcatheter devices for monitoring and treating advanced chronic heart failure patients. PA: pulmonary artery; LA: left atrium; AFR: atrial flow regulator; TASS: Transcatheter Atrial Shunt System; VNS: vagus nerve stimulation; BAT: baroreceptor activation therapy; RDN: renal sympathetic denervation; F: approval by the American regulatory agency (FDA); E: approval by the European regulatory agency (CE Mark). BACKGROUND: Innovations in devices during the last decade contributed to enhanced diagnosis and treatment of patients with cardiac insufficiency. These tools progressively adapted to minimally invasive strategies with rapid, widespread use. The present article focuses on actual and future directions of device-related diagnosis and treatment of chronic heart failure.

Bleeding in Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement: Incidence, Trends, Clinical Outcomes, and Predictors.

BACKGROUND: Bleeding is one of the most frequent complications in patients undergoing transcatheter aortic valve replacement (TAVR). Importantly, major bleeding is associated with poor clinical outcomes after TAVR. However, large studies on bleeding complications in the contemporary TAVR population are limited. OBJECTIVES: The aim of this study was to assess the incidence, temporal trends, clinical outcomes, and predictors of bleeding in patients undergoing transfemoral TAVR. METHODS: The CENTER2 study is a pooled patient-level database from 10 clinical studies including patients who underwent TAVR between 2007 and 2022. RESULTS: A total of 23,562 patients underwent transfemoral TAVR. The mean age was 81.5 ± 6.7 years, and 56% were women. Major bleeding within the first 30 days was observed in 1,545 patients (6.6%). Minor bleeding was reported in 1,143 patients (4.7%). Rates of major bleeding decreased from 11.5% in 2007-2010 to 5.5% in 2019-2022 (Ptrend < 0.001). Dual antiplatelet therapy was associated with higher major bleeding rates compared with single antiplatelet therapy (12.2% vs 9.1%; OR: 1.40; 95% CI: 1.13-1.72; P = 0.002). Patients with major bleeding had increased mortality risk during the first 30 days (14.1% vs 4.3%; OR: 3.66; 95% CI: 3.11-4.31; P < 0.001) and during 1-year follow-up (27.8% vs 14.5%; HR: 1.50; 95% CI: 1.41-1.59; P < 0.001). Minor bleeding did not affect 1-year mortality risk (16.7% vs 14.5%; HR: 1.11; 95% CI: 0.93-1.32; P = 0.27). Predictors of major bleeding were female sex and peripheral vascular disease. CONCLUSIONS: Bleeding complications remain frequent and important in patients undergoing transfemoral TAVR. Increased mortality risk in major bleeding persists after the initial 30 days. (Cerebrovascular Events in Patients Undergoing Transcatheter Aortic Valve Implantation With Balloon-Expandable Valves Versus Self-Expandable Valves [CENTER]; NCT03588247).

Patients With Diabetes at High Bleeding Risk With 1-Month Dual Antiplatelet Therapy: Onyx ONE Clear Results.

Background: Patients with diabetes mellitus (DM) are at a higher risk of ischemic events compared with patients without DM. Percutaneous coronary intervention (PCI) with the Resolute Onyx zotarolimus-eluting stent (ZES) followed by 1-month dual antiplatelet therapy (DAPT) is safe and effective in patients with high bleeding risk. However, outcomes in patients with DM are not fully understood. Methods: Onyx ONE Clear was a prospective, multicenter study that included patients receiving the Resolute Onyx ZES during PCI and 1-month DAPT. The primary end point was a composite of cardiac death (CD) or myocardial infarction from 1 month to 12 months. Results: Among the Onyx ONE Clear population (N = 1506), 39% had DM. Patients with DM had a higher incidence of hypertension, hyperlipidemia, and previous PCI and a higher body mass index than patients without DM. Patients with diabetes were also younger, more likely to be anemic, and experience renal failure. After adjusting for baseline differences between the groups, the Kaplan-Meier rates of CD or myocardial infarction (9.3% vs 6.1%; P = .122, unadjusted P = .010) and target lesion failure (10.2% vs 7.7%; P = .294, unadjusted P = .056) between 1 month and 12 months were not significantly different in patients with and without DM. The rates of target lesion revascularization were also similar in both groups, and stent thrombosis was very low and comparable in both arms after adjusting for baseline differences. Non-CD and bleeding were more frequent in patients with DM. Conclusions: Patients with diabetes treated with the Resolute Onyx ZES followed by 1-month DAPT had favorable 12-month ischemic outcomes after accounting for baseline differences between patients with and without DM, supporting the safety and efficacy of the treatment in selected patients with DM at high bleeding risk.

Curva de Aprendizagem da Mortalidade Hospitalar da Substituição da Válvula Aórtica Transcateter: Insights do Registro Nacional Brasileiro / Learning Curve for In-Hospital Mortality of Transcatheter Aortic Valve Replacement: Insights from the Brazilian National Registry

Resumo Fundamento Dados robustos sobre a curva de aprendizagem (LC) da substituição da válvula aórtica transcateter (TAVR) são escassos nos países em desenvolvimento. Objetivo Avaliar a LC da TAVR no Brasil ao longo do tempo. Métodos Analisamos dados do registro brasileiro de TAVR de 2008 a 2023. Pacientes de cada centro foram numerados cronologicamente em número sequencial de caso (NSC). A LC foi realizada usando um spline cúbico restrito ajustado para o EuroSCORE-II e o uso de próteses de nova geração. Ainda, os desfechos hospitalares foram comparados entre grupos definidos de acordo com o nível de experiência, com base no NSC: 1º ao 40º caso (experiência inicial), 41º ao 80º caso (experiência básica), 81º ao 120º caso (experiência intermediária) e 121º caso em diante (experiência alta). Análises adicionais foram conduzidas de acordo com o número de casos tratados antes de 2014 (>40 e ≤40 procedimentos). O nível de significância adotado foi p <0,05. Resultados Foram incluídos 3194 pacientes de 25 centros. A idade média foi 80,7±8,1 anos e o EuroSCORE II médio foi 7±7,1. A análise da LC demonstrou uma queda na mortalidade hospitalar ajustada após o tratamento de 40 pacientes. Um patamar de nivelamento na curva foi observado após o caso 118. A mortalidade hospitalar entre os grupos foi 8,6%, 7,7%, 5,9%, e 3,7% para experiência inicial, básica, intermediária e alta, respectivamente (p<0,001). A experiência alta foi preditora independente de mortalidade mais baixa (OR 0,57, p=0,013 vs. experiência inicial). Centros com baixo volume de casos antes de 2014 não mostraram uma redução significativa na probabilidade de morte com o ganho de experiência, enquanto centros com alto volume de casos antes de 2014 apresentaram uma melhora contínua após o caso de número 10. Conclusão Observou-se um fenômeno de LC para a mortalidade hospitalar do TAVR no Brasil. Esse efeito foi mais pronunciado em centros que trataram seus 40 primeiros casos antes de 2014 que naqueles que o fizeram após 2014.

Abstract Background Robust data on the learning curve (LC) of transcatheter aortic valve replacement (TAVR) are lacking in developing countries. Objective To assess TAVR's LC in Brazil over time. Methods We analyzed data from the Brazilian TAVR registry from 2008 to 2023. Patients from each center were numbered chronologically in case sequence numbers (CSNs). LC was performed using restricted cubic splines adjusted for EuroSCORE-II and the use of new-generation prostheses. Also, in-hospital outcomes were compared between groups defined according to the level of experience based on the CSN: 1st to 40th (initial-experience), 41st to 80th (early-experience), 81st to 120th (intermediate-experience), and over 121st (high-experience). Additional analysis was performed grouping hospitals according to the number of cases treated before 2014 (>40 and ≤40 procedures). The level of significance adopted was <0.05. Results A total of 3,194 patients from 25 centers were included. Mean age and EuroSCORE II were 80.7±8.1 years and 7±7.1, respectively. LC analysis demonstrated a drop in adjusted in-hospital mortality after treating 40 patients. A leveling off of the curve was observed after case #118. In-hospital mortality across the groups was 8.6%, 7.7%, 5.9%, and 3.7% for initial-, early-, intermediate-, and high-experience, respectively (p<0.001). High experience independently predicted lower mortality (OR 0.57, p=0.013 vs. initial experience). Low-volume centers before 2014 showed no significant decrease in the likelihood of death with gained experience, whereas high-volume centers had a continuous improvement after case #10. Conclusion A TAVR LC phenomenon was observed for in-hospital mortality in Brazil. This effect was more pronounced in centers that treated their first 40 cases before 2014 than those that reached this milestone after 2014.

Estratégias Percutâneas em Doenças Estruturais: Foco em Insuficiência Cardíaca Crônica / Percutaneous Strategies in Structural Heart Diseases: Focus on Chronic Heart Failure

Resumo As inovações em dispositivos ao longo das últimas décadas proporcionaram uma melhora no diagnóstico e tratamento de pacientes com insuficiência cardíaca. Essas novas ferramentas progressivamente adaptaram-se a estratégias minimamente invasivas e as opções percutâneas multiplicaram-se de forma rápida. No presente artigo revisamos as direções atuais e futuras dos dispositivos utilizados como opções adjuvantes para o diagnóstico e tratamento adjuvante na insuficiência cardíaca crônica, o seu desenvolvimento, mecanismos e estudos mais recentes

Abstract Innovations in devices during the last decade contributed to enhanced diagnosis and treatment of patients with cardiac insufficiency. These tools progressively adapted to minimally invasive strategies with rapid, widespread use. The present article focuses on actual and future directions of device-related diagnosis and treatment of chronic heart failure.

Same-day discharge percutaneous coronary intervention. Where are we? / Intervenção coronária percutânea com alta no mesmo dia. Onde estamos?

With the evolution of percutaneous coronary intervention techniques and their greater safety, the use of radial access, the greater need to optimize resources in health management and the greater demand from patients for an agile service to solve their problems, the discharge on the same day after percutaneous coronary interventions have been gaining ground in the global scenario as a feasible strategy. The objective of this article was to demonstrate that there is already a scientific basis for this, which extends from the financial aspect, and the patient's experience, to the technical details related to the safety of the strategy. A structured protocol based on evidence and on the most recent recommendations from two major medical societies is also proposed. Selecting patients well, training the multidisciplinary team and educating the patient are fundamental parts for the success of the strategy.

Com a evolução das técnicas de intervenção coronária percutânea e sua maior segurança, o uso do acesso radial, a maior necessidade de otimização dos recursos na gestão em saúde e a maior cobrança por parte dos pacientes por um serviço ágil para resolução de seus problemas, a alta no mesmo dia após as intervenções coronárias percutâneas vem ganhando espaço no cenário global como uma estratégia factível. O objetivo deste artigo foi demonstrar que já há base científica para o assunto, a qual se estende desde a aspectos financeiros, à experiência do paciente até à questão técnica relacionada à segurança da estratégia. Propõe-se, ainda, um protocolo estruturado baseado em evidências e nas recomendações mais recentes de duas grandes sociedades médicas. Selecionar bem os pacientes, treinar a equipe multiprofissional e educar o paciente são partes fundamentais para o sucesso da estratégia.

Evolução e Estado Atual das Práticas de Implante Transcateter de Válvula Aórtica na América Latina - Estudo WRITTEN LATAM / Recent Developments and Current Status of Transcatheter Aortic Valve Replacement Practice in Latin America - the WRITTEN LATAM Study

Resumo Fundamento: Implante transcateter de valva aórtica (TAVI) é um procedimento adotado em todo o mundo e suas práticas evoluem rapidamente. Variações regionais e temporais são esperadas. Objetivo: Comparar a prática de TAVI na América Latina com aquela no resto do mundo e avaliar suas mudanças na América Latina de 2015 a 2020. Método: A pesquisa foi realizada em centros de TAVI em todo o mundo entre março e setembro de 2015, e novamente nos centros latino-americanos entre julho de 2019 e janeiro de 2020. As seguintes questões foram abordadas: i) informação geral sobre os centros; ii) avaliação pré-TAVI; iii) técnicas do procedimento; iv) conduta pós-TAVI; v) seguimento. As respostas da pesquisa dos centros latino-americanos em 2015 (LATAM15) foram comparadas àquelas dos centros no resto do mundo (WORLD15) e ainda àquelas da pesquisa dos centros latino-americanos de 2020 (LATAM20). Adotou-se o nível de significância de 5% na análise estatística. Resultados: 250 centros participaram da pesquisa em 2015 (LATAM15=29; WORLD15=221) e 46 na avaliação LATAM20. No total, foram 73.707 procedimentos, sendo que os centros WORLD15 realizaram, em média, 6 e 3 vezes mais procedimentos do que os centros LATAM15 e LATAM20, respectivamente. Os centros latino-americanos realizaram menor número de TAVI minimalista do que os do restante do mundo, mas aumentaram significativamente os procedimentos menos invasivos após 5 anos. Quanto à assistência pós-procedimento, observaram-se menor tempo de telemetria e de manutenção do marca-passo temporário, além de menor uso de terapia dupla antiplaquetária nos centros LATAM20. Conclusão: A despeito do volume de procedimentos ainda significativamente menor, muitos aspectos da prática de TAVI nos centros latino-americanos evoluíram recentemente, acompanhando a tendência dos centros dos países desenvolvidos.

Abstract Background: Transcatheter aortic valve replacement (TAVR) is a worldwide adopted procedure with rapidly evolving practices. Regional and temporal variations are expected to be found. Objective: To compare TAVR practice in Latin America with that around the world and to assess its changes in Latin America from 2015 to 2020. Methods: A survey was applied to global TAVR centers between March and September 2015, and again to Latin-American centers between July 2019 and January 2020. The survey consisted of questions addressing: i) center's general information; ii) pre-TAVR evaluation; iii) procedural techniques; iv) post-TAVR management; v) follow-up. Answers from the 2015 survey of Latin-American centers (LATAM15) were compared with those of other centers around the world (WORLD15) and with the 2020 updated Latin-American survey (LATAM20). A 5% level of significance was adopted for statistical analysis. Results: 250 centers participated in the 2015 survey (LATAM15=29; WORLD15=221) and 46 in the LATAM20. Combined centers experience accounted for 73 707 procedures, with WORLD15 centers performing, on average, 6- and 3-times more procedures than LATAM15 and LATAM20 centers, respectively. LATAM centers performed less minimalistic TAVR than WORLD15 centers, but there was a significant increase in less invasive procedures after 5 years in Latin-American centers. For postprocedural care, a lower period of telemetry and maintenance of temporary pacing wire, along with less utilization of dual antiplatelet therapy was observed in LATAM20 centers. Conclusion: Despite still having a much lower number of procedures, many aspects of TAVR practice in Latin-American centers have evolved in recent years, followingthe trend observed in developed country centers.

Ablação septal com cateteres e radiofrequência guiada pela ecocardiografia para tratamento de pacientes com cardiomiopatia hipertrófica obstrutiva: experiência inicial / Septal ablation with radiofrequency catheters guided by echocardiography for treatment of patients with obstructive hypertrophic cardiomyopathy: initial experience

BACKGROUND: Hypertrophic cardiomyopathy (HCM) can cause obstruction in the left ventricular outflow tract (LVOT), and be responsible for the onset of limiting symptoms, such as tiredness. When such symptoms are refractory to pharmacological treatment, interventionist alternative therapies can be useful, such as septal ablation through the infusion of alcohol in the coronary artery or through myectomy. Recently, the use of a radiofrequency (RF) catheter for endocardial septal ablation guided by electroanatomic mapping has proven to be efficient, despite the high incidence of complete atrioventricular block. An alternative would be the application of RF at the beginning point of the septal gradient guided by the transesophageal echocardiography (TEE). The echocardiography is an imaging method with high accuracy to determine septal anatomy. OBJECTIVE: To assess the long term effect of septal ablation for the relief of ventricular-arterial gradient, using TEE to help place the catheter in the area of larger septal obstruction. Besides, to assess the effects of ablation on the functional class and echocardiographic parameters. METHODS: Twelve asymptomatic patients, with LVOT obstruction, refractory to pharmacological therapy, underwent endocardial septal ablation with 8mm-tip catheters, whose placement was oriented in the region of larger obstruction, assisted by the TEE. Temperature-controlled and staggered RF applications were performed. After each application, the gradient was reassessed and a new application was performed according to the clinical criterion. The effects of RF applications were assessed both for the gradient at rest and for that provoked by the Valsalva maneuver, and considering the gradient. The differences were significant when p-value was lower than or equal to 0.05. RESULTS: It was possible to observe that the mean reduction of the maximum gradients was from 96.8±34.7 mmHg to 62.7±25.4 mmHg three months after the procedure (p=0.0036). After one year, the mean of maximum gradient was 36.1±23.8 mmHg (p=0.0001). The procedure was well tolerated, without records of complete atrioventricular block nor severe complications. CONCLUSION: The TEE-guided septal ablation was efficient and safe, and the results were maintained during the clinical follow-up period. It is a reasonable option for the interventionist treatment of LVOT obstruction in HCM.

FUNDAMENTOS: A cardiomiopatia hipertrófica (CMH) pode causar obstrução da via de saída do ventrículo esquerdo (VSVE) e ser responsável pelo surgimento de sintomas limitantes, como cansaço físico. Quando tais sintomas são refratários ao tratamento farmacológico, os tratamentos alternativos intervencionistas podem ser úteis, como a ablação septal por meio da infusão de álcool na artéria coronária ou por meio da miectomia cirúrgica. Recentemente, o uso de cateter de radiofrequência (RF) para ablação do septo endocárdico guiado por mapeamento eletroanatômico mostrou-se eficaz apesar da elevada incidência de bloqueio atrioventricular total. Uma alternativa seria a aplicação de radiofrequência no ponto de início do gradiente septal guiada pelo ecocardiograma transesofágico (ETE). O ecocardiograma é um método de imagem com elevada acurácia para determinação da anatomia septal. OBJETIVO: Avaliar o efeito em longo prazo da ablação septal para alívio do gradiente ventrículo-arterial, utilizando o ETE para auxiliar no posicionamento do cateter na área de maior obstrução septal. Avaliar também os efeitos da ablação na classe funcional e parâmetros ecocardiográficos. MÉTODOS: Doze pacientes sintomáticos com obstrução da VSVE, refratários à terapia farmacológica, foram submetidos à ablação endocárdica septal com cateteres com ponta de 8 mm, cujo posicionamento foi orientado na região de maior obstrução com auxílio do ETE. Foram realizadas aplicações de radiofrequência (RF) termocontrolada e escalonadas sobre a área alvo. Após cada aplicação, o gradiente era reavaliado e nova aplicação era realizada de acordo com critério clínico. Foram avaliados os efeitos das aplicações de RF tanto para o gradiente em repouso como para o provocado por meio da manobra de Valsalva, e considerado o gradiente. As diferenças foram significativas quando o valor de p foi menor ou igual a 0,05. RESULTADOS: Observou-se que a redução da média dos gradientes máximos obtidos foi de 96,8±34,7 mmHg para 62,7±25,4 mmHg ao final de três meses do procedimento (p=0,0036). Após um ano, a média dos gradientes máximos obtidos foi de 36,1±23,8 mmHg (p=0,0001). O procedimento foi bem tolerado e não houve registro de bloqueio atrioventricular total e nem complicações graves. CONCLUSÃO: A ablação septal guiada pelo ETE foi eficaz e segura, com resultados mantidos durante o período de seguimento clínico. É uma opção razoável para o tratamento intervencionista da obstrução da VSVE em CMH.

A Relação entre Regurgitação Mitral e Implante Transcateter de Válvula Aórtica: um Estudo de Acompanhamento Multi-Institucional / Relationship between Mitral Regurgitation and Transcatheter Aortic Valve Implantation: a Multi-Institutional Follow-up Study

Resumo Fundamento A regurgitação mitral (RM) é prevalente em pacientes submetidos a implante transcateter de válvula aórtica (TAVI). Há algumas controvérsias sobre o impacto prognóstico da RM na sobrevida de pacientes submetidos a TAVI. Objetivo Examinar a relação entre TAVI e RM em uma população de pacientes do Registro Brasileiro de TAVI. Métodos Setecentos e noventa e cinco pacientes do Registro Brasileiro de TAVI foram divididos na linha de base, alta e acompanhamento de acordo com o grau da RM da maneira seguinte: ausente/leve (RMAL) ou moderado/grave (RMMG). Eles foram subsequentemente reagrupados de acordo com as mudanças imediatas e tardias na gravidade da RM após TAVI da maneira seguinte: RM sem mudança, melhora ou piora. Foram analisados os preditores e o impacto prognóstico na linha de base, bem como as mudanças na gravidade da RM. A significância estatística foi estabelecida em p < 0,05. Resultados RMMG basal estava presente em 19,3% dos pacientes e foi um preditor de aumento da mortalidade tardia. Imediatamente após o TAVI, 47,4% dos casos melhoraram para RMAL, previsto por uma pontuação mais alta da Society of Thoracic Surgeons e um grau mais alto de regurgitação aórtica basal. No acompanhamento, 9,2% dos casos de RMAL pioraram para RMMG, enquanto 36,8% dos casos de RMMG melhoraram para RMAL. Fração de ejeção do ventrículo esquerdo (FEVE) mais baixa na linha de base e melhora na FEVE durante o acompanhamento foram preditores de melhora da RM. Piora progressiva da RM no acompanhamento foi um preditor independente de maior mortalidade tardia após TAVI (p = 0,005). Conclusões A RMMG na linha de base é um preditor de mortalidade tardia após TAVI. FEVE mais baixa e melhora na FEVE durante o acompanhamento são preditores de melhora da RM após TAVI. A pior progressiva da gravidade da RM durante o acompanhamento é um preditor independente de mortalidade tardia; isto é um achado raro na literatura.

Abstract Background Mitral regurgitation (MR) is prevalent in patients undergoing transcatheter aortic valve implantation (TAVI). There are some controversies about the prognostic impact of MR in survival of TAVI patients. Objective To examine the relationship between TAVI and MR in a patient population from the Brazilian TAVI Registry. Methods Seven hundred and ninety-five patients from the Brazilian TAVI Registry were divided at baseline, discharge, and follow-up according to their MR grade as follows: absent/mild (AMMR) or moderate/severe (MSMR). They were subsequently regrouped according to their immediate and late changes in MR severity after TAVI as follows: no change, improved, or worsened MR. Predictors and prognostic impact on baseline as well as changes in MR severity were analyzed. Statistical significance was set at p < 0.05. Results Baseline MSMR was present in 19.3% of patients and was a predictor of increased late mortality. Immediately after TAVI, 47.4 % of cases improved to AMMR, predicted by a higher Society of Thoracic Surgeons score and a higher grade of baseline aortic regurgitation. Upon follow-up, 9.2% of cases of AMMR worsened to MSMR, whereas 36.8% of cases of MSMR improved to AMMR. Lower baseline left ventricular ejection fraction (LVEF) and improvement in LVEF at follow-up were predictors of MR improvement. Progressive worsening of MR upon follow-up was an independent predictor of higher late mortality after TAVI (p = 0.005). Conclusions Baseline MSMR predicts late mortality after TAVI. Lower LVEF and improved LVEF at follow-up predict MR improvement after TAVI. Progressive worsening of MR severity at follow-up is an independent predictor of late mortality, which is a rare finding in the literature.

Imagem Cardiovascular e Procedimentos Intervencionistas em Pacientes com Infecção pelo Novo Coronavírus / Cardiovascular Imaging and Interventional Procedures in Patients with Novel Coronavirus Infection

Resumo A pandemia da doença causada pelo novo coronavírus (COVID-19) trouxe grandes desafios para o sistema de saúde devido ao aumento exponencial do número de pacientes acometidos. A racionalização de recursos e a indicação correta e criteriosa de exames de imagem e procedimentos intervencionistas tornaram-se necessárias, priorizando a segurança do paciente, do ambiente e dos profissionais da saúde. Esta revisão visa auxiliar e orientar os profissionais envolvidos na realização desses exames e procedimentos a fazê-los de forma eficaz e segura.

Abstract The coronavirus disease 2019 (COVID-19) pandemic is a huge challenge to the health system because of the exponential increase in the number of individuals affected. The rational use of resources and correct and judicious indication for imaging exams and interventional procedures are necessary, prioritizing patient, healthcare personnel, and environmental safety. This review was aimed at guiding health professionals in safely and effectively performing imaging exams and interventional procedures.

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

Stents farmacológicos: estado atual / Drug-eluting stents: state-of-the-art

Stents farmacológicos foram desenvolvidos para reduzir a resposta proliferativa neointimal e consequentemente a reestenose, mais frequente limitação da intervenção coronária percutânea com balão e stents não faramcológicos. O desenvolvimento destes dispositivos baseia-se no maior entendimento da biologia da reestenose, na seleção de fármacos anti-proliferativos adequados para os diversos mecanismos envolvidos nesta complicação e no uso de plataformas/polímeros adequados para entrega do fármaco. Consequentemente o desempenho destes dispositivos depende da perfeita interação de todos estes elementos. As abordagens atuais para minimizar a reestenose são revisados neste capítulo. Embora a primeira geração dos stents farmacológicos tenha sido focada na eficácia em reduzir a reestenose, questões relacionadas à sua segurança surgiram, comprometendo seu uso mais disseminado. As novas gerações de stents farmacológicos com polímeros duráveis ou bioabsorvíveis conseguiu reduzir as taxas de nova intervenção e de trombose. Embora o modelo ideal de stent farmacológico ainda esteja em investigação, é certo que esta tecnologia já se estabeleceu como primeira linha na intervenção coronária percutânea contemporânea