Coronary artery complications after left bundle branch area pacing: An increasingly reported issue in the era of physiologic pacing.

Coronary artery lesions related to pacemaker implantation are rare complications. With the increasing adoption of the technique of permanent transseptal pacing of the left bundle branch area pacing (LBBAP), an increase in the incidence of these complications may be expected. We report two cases of coronary lesions after permanent transeptal pacing of the LBBAP: the first with a small coronary artery fistula, and the second with an extrinsic coronary compression. Both complications occurred with stylet-driven pacing leads with extendable helix. In the first case, since the shunt volume was small and no major complications were reported, the patient was treated conservatively with good outcome. The second case required lead repositioning due to acute decompensated heart failure.

Influenza vaccination strategy in acute coronary syndromes: the VIP-ACS trial.

AIMS: To evaluate whether a strategy of double-dose influenza vaccination during hospitalization for an acute coronary syndrome (ACS) compared with standard-dose outpatient vaccination (as recommended by current guidelines) would further reduce the risk of major cardiopulmonary events. METHODS AND RESULTS: Vaccination against Influenza to Prevent cardiovascular events after Acute Coronary Syndromes (VIP-ACS) was a pragmatic, randomized, multicentre, active-comparator, open-label trial with blinded outcome adjudication comparing two strategies of influenza vaccination following an ACS: double-dose quadrivalent inactivated vaccine before hospital discharge vs. standard-dose quadrivalent inactivated vaccine administered in the outpatient setting 30 days after randomization. The primary outcome was a hierarchical composite of all-cause death, myocardial infarction, stroke, unstable angina, hospitalization for heart failure, urgent coronary revascularization, and hospitalization for respiratory causes, analysed by the win ratio method. Patients were followed for 12 months. During two influenza seasons, 1801 participants were included at 25 centres in Brazil. The primary outcome was not different between groups, with 12.7% wins in-hospital double-dose vaccine group and 12.3% wins in the standard-dose vaccine group {win ratio: 1.02 [95% confidence interval (CI): 0.79-1.32], P = 0.84}. Results were consistent for the key secondary outcome, a hierarchical composite of cardiovascular death, myocardial infarction and stroke [win ratio: 0.94 (95% CI: 0.66-1.33), P = 0.72]. Time-to-first event analysis for the primary outcome showed results similar to those of the main analysis [hazard ratio 0.97 (95% CI: 0.75-1.24), P = 0.79]. Adverse events were infrequent and did not differ between groups. CONCLUSION: Among patients hospitalized with an ACS, double-dose influenza vaccination before discharge did not reduce cardiopulmonary outcomes compared with standard-dose vaccination in the outpatient setting. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov number: NCT04001504.

Outcomes and predictors of mortality after transcatheter aortic valve implantation: results of the Brazilian registry.

OBJECTIVE: The study sought to evaluate outcomes and predictors of mortality after transcatheter aortic valve implantation (TAVI). BACKGROUND: TAVI registries can reliably address outcomes and issues that adversely affect results in real-life. METHODS: All endpoints and complications were analyzed according to Valve Academic Research Consortium-2 criteria. RESULTS: Between January 2008 and January 2013, 418 patients underwent TAVI in 18 centers and were included in the Brazilian registry. The transfemoral approach was used in 96.2% of the procedures. The CoreValve and Sapien XT prosthesis were used in 360 (86.1%) and 58 (13.9%) cases, respectively. All-cause mortality at 30 days and 1 year were 9.1 and 21.5%. Chronic obstructive pulmonary disease (COPD) (HR: 3.50), acute kidney injury (AKI) (HR: 3.07), stroke (HR: 2.71) and moderate/severe paravalvular regurgitation (PVR) (HR: 2.76) emerged as independent predictors of overall mortality. COPD (OR: 3.00), major vascular complications (OR: 7.99) and device malpositioning (OR: 6.97) were predictors of early (≤30 days) mortality, while COPD (HR: 2.68), NYHA class III/IV (HR: 3.04), stroke (HR: 4.15), AKI (HR: 2.44) and moderate/severe PVR (HR: 3.20) impacted late (>30 days) mortality. The use of transesophageal echocardiogram (TEE) to monitor the procedure was found to be a protective factor against overall (HR: 0.57) and late (HR: 0.47) mortality. CONCLUSION: This multicenter registry reflected a real-life national TAVI experience. Comorbidities, periprocedural complications and moderate/severe PVR were associated with increased mortality and the use of TEE to monitor the procedure acted as a protective factor.

In-Hospital influenza vaccination to prevent cardiorespiratory events in the first 45 days after acute coronary syndrome: A prespecified analysis of the VIP-ACS trial.

BACKGROUND: Influenza vaccination prevents major cardiovascular events in individuals presenting a recent acute coronary syndrome (ACS), however the early effect of an in-hospital double-dose vaccination strategy remains uncertain. METHODS: The VIP-ACS was a randomized, pragmatic, multicenter, open-label trial with a blinded-adjudication endpoint. Patients with ACS ≤ 7 days of hospitalization were randomized to an in-hospital double-dose quadrivalent inactivated influenza vaccine (double-dose) or a standard-dose influenza vaccine at 30 days post-randomization. The primary endpoint was a hierarchical composite of death, myocardial infarction, stroke, hospitalization for unstable angina, hospitalization for heart failure, urgent coronary revascularization, and hospitalization for respiratory infections, analyzed with the win ratio (WR) method in short-term follow-up (45-days after randomization). RESULTS: The trial enrolled 1,801 patients (≥18 years old). Median participant age was 57 years, 70 % were male. There were no significant differences between groups on the primary hierarchical endpoint: there were 5.7 % wins in the double-dose in-hospital group and 5.5 % wins in the standard-dose delayed vaccination group (WR: 1.03; 95 % CI: 0.70---1.53; P = 0.85). In a sensitivity analysis including COVID-19 infection in the hospitalizations for respiratory infections endpoint, overall results were maintained (WR: 1.03; 95 % CI 0.71---1.51; P = 0.87). Results were consistent for major cardiovascular events only (WR: 0.82; 95 % CI: 0.48---1.39; P = 0.46). No serious adverse events were observed. CONCLUSION: In patients with recent ACS, in-hospital double-dose influenza vaccination did not significantly reduce cardiorespiratory events at 45 days compared with standard-dose vaccination at 30 days post-randomization.

Clinical impact of sex differences and procedural setting in transcatheter aortic valve implantation.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a well-established treatment for symptomatic patients with aortic stenosis. Yet, the impact of sex differences and public vs. private procedural setting on TAVI outcomes remain uncertain. METHODS: The RIBAC-NT (Brazilian Registry for Evaluation of Transcatheter Aortic Valve Replacement Outcomes) dataset included 3194 TAVI patients from 2009 to 2021. This retrospective analysis explored disparities in baseline characteristics, procedural and in-hospital outcomes stratifying patients by sex and procedural setting. Temporal trends were also investigated. RESULTS: We included 1551 (49 %) female and 1643 (51 %) male patients. Women were older (83 [78-87] vs. 81 [75-85] years; p < 0.01) but had a lower prevalence of diabetes mellitus (30.2 % vs. 36.3 %, p < 0.01) and coronary artery disease (39.0 % vs. 52.2 %, p < 0.01). However, women had a 3-fold higher higher risk of life-threatening bleeding (6.1 % vs. 2.4 %, p < 0.01). Women presented higher procedural and in-hospital mortality rates (4.4 % vs. 2.5 % and 7.7 % vs. 4.5 %, all p < 0.01, respectively). Although public hospitals presented ~2-fold higher procedural mortality rate compared with private settings (5.0 % vs. 2.7 %, p < 0.01), after multivariable analysis procedural setting was not independently associated with in-hospital mortality. CONCLUSIONS: Women had higher procedural and in-hospital mortality rates after TAVI as compared with men, while facing higher life-threatening bleeding and adverse events rates. Although public hospitals exhibited higher mortality rates than private centers, procedural setting was not independently associated with in-hospital mortality.

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.

Prognostic Assessment of Fractional Flow Reserve in Different Strata in Patients with Coronary Artery Disease. / Avaliação Prognóstica da Reserva de Fluxo Fracionada em Diferentes Estratos nos Pacientes com Doença Arterial Coronariana.

BACKGROUND: There are limited real-world data on the clinical course of untreated coronary lesions according to their functional severity. OBJECTIVE: To evaluate the 5-year clinical outcomes of patients with revascularized lesions with fractional flow reserve (FFR) ≤ 0.8 and patients with non-revascularized lesions with FFR > 0.8. METHODS: The FFR assessment was performed in 218 patients followed for up to 5 years. Participants were classified based on FFR into ischemia group (≤ 0.8, intervention group, n = 55), low-normal FFR group (> 0.8-0.9, n = 91), and high-normal FFR group (> 0.9, n = 72). The primary endpoint was major adverse cardiac events (MACEs), a composite of death, myocardial infarction, and need for repeat revascularization. The significance level was set at 0.05; therefore, results with a p-value < 0.05 were considered statistically significant. RESULTS: Most patients were male (62.8%) with a mean age of 64.1 years. Diabetes was present in 27%. On coronary angiography, the severity of stenosis was 62% in the ischemia group, 56.4% in the low-normal FFR group, and 54.3% in the high-normal FFR group (p<0.05). Mean follow-up was 3.5 years. The incidence of MACEs was 25.5%, 13.2%, and 11.1%, respectively (p=0.037). MACE incidence did not differ significantly between the low-normal and high-normal FFR groups. CONCLUSION: Patients with FFR indicative of ischemia had poorer outcomes than those in non-ischemia groups. There was no difference in the incidence of events between the low-normal and high-normal FFR groups. Long-term studies with a large sample size are needed to better assess cardiovascular outcomes in patients with moderate coronary stenosis with FFR values between 0.8 and 1.0.

FUNDAMENTO: Existem dados limitados sobre a evolução clínica de lesões coronarianas não tratadas de acordo com sua gravidade funcional no mundo real. OBJETIVO: Este estudo teve como objetivo avaliar os resultados clínicos de até 5 anos em pacientes com lesões revascularizadas com reserva de fluxo fracionada (FFR) ≤ 0,8 e em pacientes com lesões não revascularizadas com FFR > 0,8. MÉTODOS: A avaliação pelo FFR foi realizada em 218 pacientes seguidos por até 5 anos. Os participantes foram classificados com base na FFR no grupo isquêmico (≤ 0,8, grupo intervenção, n = 55), no grupo FFR normal-baixa (> 0,8-0,9, n = 91) e no grupo FFR normal-alta (> 0,9, n = 72). O desfecho primário foram eventos cardíacos adversos maiores (ECAMs), um composto de morte, infarto do miocárdio e necessidade de nova revascularização. O nível de significância adotado neste estudo foi alfa = 0,05; deste modo, resultados com valores de p < 0,05 foram considerados estatisticamente significativos. RESULTADOS: A maioria dos participantes era do sexo masculino (62,8%) com média de idade de 64,1 anos. Diabetes estava presente em 27%. À angiografia coronariana, a gravidade da estenose avaliada foi de 62%, 56,4% e 54,3% nos grupos isquêmico, FFR normal-baixa e FFR normal-alta, respectivamente (p < 0,05). O período médio de acompanhamento foi de 3,5 anos. A incidência ECAM foi de 25,5%, 13,2% e 11,1%, respectivamente (p = 0,037). Não houve diferença na incidência de ECAM entre os grupos FFR normal-baixa e FFR normal-alta (p = NS). CONCLUSÃO: Pacientes com FFR indicativa de isquemia apresentaram piores desfechos quando comparados aos dos grupos não isquêmicos. Entre os grupos que apresentaram valores de FFR considerados normal-baixo e normal-alto, não houve diferença na incidência de eventos. Há necessidade de estudos de longo prazo e com grande número de pacientes para melhor avaliar os desfechos cardiovasculares em pacientes portadores de estenose coronariana moderada com valores de FFR entre 0,8 e 1,0.

[Metabolic syndrome in workers in a university hospital]. / Síndrome metabólica em trabalhadores de um hospital universitário.

INTRODUCTION: Metabolic syndrome (MS) is a major health problem, and has economic effects on enterprises. The workplace is thus an important environment for primary prevention of risk factors for cardiovascular disease. OBJECTIVE: To determine the prevalence of MS and variables related to its development in hospital workers. METHODS: We performed a cross-sectional study of 740 workers in a large university hospital. Socioeconomic variables, anthropometric and blood pressure measurements, and laboratory exams were analyzed. MS was defined according to the criteria of the International Diabetes Federation. RESULTS: Of the 740 workers, 72.4% were female and mean age was 34.9±9.5 years; 27.8% worked the morning shift, 20.3% the afternoon shift, 34.1% office hours, and 17.8% the night shift. As to educational level, 86.6% had finished high school or college. Waist circumference was high in 55.4%. Overall MS prevalence was 12.8%, 16.2% in males and 11.6% in females. Logistic regression analysis showed an independent association between MS and the following variables: elementary education, period of employment >10 years, office hours shift, and age group. CONCLUSION: A diagnosis of MS was affected by age, educational level, work shift, and prolonged period of employment. Hospital workers do not differ from other populations and also need stimuli to make preventive changes to their behavior to modify cardiovascular risk factors.

Loss of short-term symptomatic benefit in patients with an occluded infarct artery is unrelated to non-protocol revascularization: results from the Occluded Artery Trial (OAT).

BACKGROUND: the OAT found that routine late (3-28 days post-myocardial infarction) percutaneous coronary intervention (PCI) of an occluded infarct-related artery did not reduce death, reinfarction, or heart failure relative to medical treatment (MED). Angina rates were lower in PCI early, but the advantage over MED was lost by 3 years. METHODS: angina and revascularization status were collected at 4 months, then annually. We assessed whether non-protocol revascularization procedures in MED accounted for loss of the early symptomatic advantage of PCI. RESULTS: seven per 100 more PCI patients were angina-free at 4 months (P < .001) and 5 per 100 at 12 months (P = .005) with the difference narrowing to 1 per 100 at 3 years (P = .34). Non-protocol revascularization was more frequent in MED (5-year rate 22% vs 19% PCI, P = .05). Indications for revascularization included acute coronary syndromes (39% PCI vs 38% MED), stable angina/inducible ischemia (39% in each group), and physician preference (17% PCI vs 15% MED). Revascularization rates among patients with angina at any time during follow-up (35% of cohort) did not differ by treatment group (5-year rates 26% PCI vs 28% MED). Most symptomatic patients were treated without revascularization during follow-up (77%). CONCLUSIONS: in a large randomized clinical trial of stable post-myocardial infarction patients, the modest benefit on angina from PCI of an occluded infarct-related artery was lost by 3 years. Revascularization was slightly more common in MED during follow-up but was not driven by acute ischemia, and almost 1 in 5 procedures were attributed to physician preference alone.

The Occluded Artery Trial (OAT) Viability Ancillary Study (OAT-NUC): influence of infarct zone viability on left ventricular remodeling after percutaneous coronary intervention versus optimal medical therapy alone.

BACKGROUND: The Occluded Artery Trial (OAT) showed no difference in outcomes between percutaneous coronary intervention (PCI) versus optimal medical therapy (MED) in patients with persistent total occlusion of the infarct-related artery 3 to 28 days post-myocardial infarction. Whether PCI may benefit a subset of patients with preservation of infarct zone (IZ) viability is unknown. METHODS AND RESULTS: The OAT nuclear ancillary study hypothesized that (1) IZ viability influences left ventricular (LV) remodeling and that (2) PCI as compared with MED attenuates adverse remodeling in post-myocardial infarction patients with preserved viability. Enrolled were 124 OAT patients who underwent resting nitroglycerin-enhanced technetium-99m sestamibi single-photon emission computed tomography (SPECT) before OAT randomization, with repeat imaging at 1 year. All images were quantitatively analyzed for infarct size, IZ viability, LV volumes, and function in a core laboratory. At baseline, mean infarct size was 26% ± 18 of the LV, mean IZ viability was 43% ± 8 of peak uptake, and most patients (70%) had at least moderately retained IZ viability. There were no significant differences in 1-year end-diastolic or end-systolic volume change between those with severely reduced versus moderately retained IZ viability, or when compared by treatment assignment PCI versus MED. In multivariable models, increasing baseline viability independently predicted improvement in ejection fraction (P = .005). There was no interaction between IZ viability and treatment assignment for any measure of LV remodeling. CONCLUSIONS: In the contemporary era of MED, PCI of the infarct-related artery compared with MED alone does not impact LV remodeling irrespective of IZ viability.

Stages of change for fruit and vegetable intake among patients with atherosclerotic disease.

This paper describes the stages of change in fruit and vegetable intake among patients with atherosclerotic disease, identifying demographic, socioeconomic, and health predictive factors for each stage of change. It is a cross-sectional study of 290 consecutive patients with atherosclerotic disease submitted to endovascular procedures in two referral hospitals. The staging algorithm included intentional and behavioral criteria, and patients were categorized into "pre-action" (pre-contemplation, contemplation, and preparation), or "action" (action, non-reflective action, and maintenance). Most of the patients were in action for the fruits intake (67.9%) and pre-action for the vegetables intake (69.1%). The logistic regression analysis for the stages of action change for fruits intake has identified as predictive factors, the higher level of education and consultation with a cardiologist. For the stages of action change for vegetable intake, absence of abdominal obesity, previous cardiac surgery, and consultation with dietitian have shown significant association. This study has shown differences in the distribution of stages of change for the fruits and vegetable intake among the patients with atherosclerotic disease. The different predictive factors for the stage of changes for fruits and vegetables suggest that approaches of nutritional orientation of the individuals must be distinct for each eating behavior.

Emergency Percutaneous Treatment of Saphenous Vein Graft Perforation After Cardiac Surgery.

Immediately post coronary artery bypass graft surgery, a 58-year-old woman developed excessive bleeding through the chest drains and hemodynamic instability, followed by total atrioventricular block requiring use of temporary pacemaker, which precluded electrocardiographic interpretation. She was referred for urgent diagnostic coronary angiography, which demonstrated important contrast leakage from the distal body of the saphenous vein graft to the first marginal branch. Acute saphenous vein graft perforation following coronary artery bypass graft surgery is rare. To the best of our knowledge, this is the first case report of acute saphenous vein graft perforation after coronary artery bypass graft surgery treated with a stent-graft.

Performance of Prediction Models for Contrast-Induced Acute Kidney Injury after Transcutaneous Aortic Valve Replacement.

BACKGROUND: Acute kidney injury (AKI) has shown to adversely affect outcomes in patients undergoing transcutaneous aortic valve replacement (TAVR), and its correct risk estimation may interfere in procedural planning and strategies. The aim of the study was to test and compare 6 scores in predicting AKI after TAVR. METHODS: We tested 6 scores (the contrast material limit score, volume-to-creatinine clearance ratio, ACEF, CR4EATME3AD3, Mehran model A, and Mehran model B) in a total of 559 consecutive patients included in the Brazilian TAVR registry. RESULTS: All scores had a poor accuracy and calibration to predict the occurrence of AKI grade 1 or 2. All scores improved the accuracy of AKI risk prediction when stratified for AKI grade 2/3 and AKI grade 3 for all scores. The CR4EATME3AD3 was the best predictor of AKI stage 2/3 (AUC: 0.62; OR: 1.12; 95% CI 1.01-1.26; p = 0.04) and AKI stage 3 (AUC: 0.64; OR: 1.16; 95% CI 1.02-1.32; p = 0.02). Mehran models A and B were both good models for AKI stage 3 (AUC: 0.63; OR: 1.10; 95% CI 1.01-1.22; p = 0.05; and AUC: 0.62; OR: 1.10; 95% CI 1.00-1.21; p = 0.05, respectively). CONCLUSIONS: None of the current models demonstrated validity in detecting AKI when its lower grades were evaluated. CR4EATME3AD3 was the best score in predicting moderate to severe AKI after TAVR. These findings suggest that contrast-induced AKI may not be the only factor related to kidney injury after TAVR.

Improvement of renal function after transcatheter aortic valve replacement in patients with chronic kidney disease.

BACKGROUND: Chronic kidney disease is commonly found in patients with aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) and has marked impact in their prognosis. It has been shown however that TAVR may improve renal function by alleviating the hemodynamic barrier imposed by AS. Nevertheless, the predictors of and clinical consequences of renal function improvement are not well established. Our aim was to assess the predictors of improvement of renal function after TAVR. METHODS: The present work is an analysis of the Brazilian Registry of TAVR, a national non-randomized prospective study with 22 Brazilian centers. Patients with baseline renal dysfunction (estimated glomerular filtration rate [eGFR] < 60mL/min/1.73m2) were stratified according to renal function after TAVR: increase >10% in eGFR were classified as TAVR induced renal function improvement (TIRFI); decrease > 10% in eGFR were classified as acute kidney injury (AKI) and stable renal function (neither criteria). RESULTS: A total of 819 consecutive patients with symptomatic severe AS were included. Of these, baseline renal dysfunction (estimated glomerular filtration rate [eGFR] < 60mL/min/1.73m2) was present in 577 (70%) patients. Considering variance in renal function between baseline and at discharge after TAVR procedure, TIRFI was seen in 197 (34.1%) patients, AKI in 203 (35.2%), and stable renal function in 177 (30.7%). The independent predictors of TIRFI were: absence of coronary artery disease (OR: 0.69; 95% CI 0.48-0.98; P = 0.039) and lower baseline eGFR (OR: 0.98; 95% CI 0.97-1.00; P = 0.039). There was no significant difference in 30-day and 1-year all-cause mortality between patients with stable renal function or TIRFI. Nonetheless, individuals that had AKI after TAVR presented higher mortality compared with TIRFI and stable renal function groups (29.3% vs. 15.4% vs. 9.5%, respectively; p < 0.001). CONCLUSIONS: TIRFI was frequently found among baseline impaired renal function individuals but was not associated with improved 1-year outcomes.

Lack of benefit from percutaneous intervention of persistently occluded infarct arteries after the acute phase of myocardial infarction is time independent: insights from Occluded Artery Trial.

AIMS: The Occluded Artery Trial (OAT) (n = 2201) showed no benefit for routine percutaneous intervention (PCI) (n = 1101) over medical therapy (MED) (n = 1100) on the combined endpoint of death, myocardial infarction (MI), and class IV heart failure (congestive heart failure) in stable post-MI patients with late occluded infarct-related arteries (IRAs). We evaluated the potential for selective benefit with PCI over MED for patients enrolled early in OAT. METHODS AND RESULTS: We explored outcomes with PCI over MED in patients randomized to the

Randomized evaluation of two drug-eluting stents with identical metallic platform and biodegradable polymer but different agents (paclitaxel or sirolimus) compared against bare stents: 1-year results of the PAINT trial.

OBJECTIVES: We tested two novel drug-eluting stents (DES), covered with a biodegradable-polymer carrier and releasing paclitaxel or sirolimus, which were compared against a bare metal stent (primary objective). The DES differed by the drug, but were identical otherwise, allowing to compare the anti-restenosis effects of sirolimus versus paclitaxel (secondary objective). BACKGROUND: The efficacy of novel DES with biodegradable polymers should be tested in the context of randomized trials, even when using drugs known to be effective, such as sirolimus and paclitaxel. METHODS: Overall, 274 patients with de novo coronary lesions in native vessels scheduled for stent implantation were randomly assigned (2:2:1 ratio) for the paclitaxel (n = 111), sirolimus (n = 106), or bare metal stent (n = 57) groups. Angiographic follow-up was obtained at 9 months and major cardiac adverse events up to 12 months. RESULTS: Both paclitaxel and sirolimus stents reduced the 9-month in-stent late loss (0.54-0.44 mm, 0.32-0.43 mm, vs. 0.90-0.45 mm respectively), and 1-year risk of target vessel revascularization and combined major adverse cardiac events (P < 0.05 for both, in all comparisons), compared with controls. Sirolimus stents had lower late loss than paclitaxel stents (P < 0.01), but similar 1-year clinical outcomes. There were no differences in the risk of death, infarction, or stent thrombosis among the study groups. CONCLUSION: Both novel DES were effective in reducing neointimal hyperplasia and 1-year re-intervention, compared to bare metal stents. Our findings also suggest that sirolimus is more effective than paclitaxel in reducing angiographic neointima, although this effect was not associated with better clinical outcomes.

Maintenance of hemodialysis arteriovenous fistulas by an interventional strategy: clinical and duplex ultrasonographic surveillance followed by transluminal angioplasty.

OBJECTIVE: A native arteriovenous fistula (NAF) is a widely used access location for hemodialysis (HD). Monitoring of the NAF followed by percutaneous transluminal angioplasty (PTA) as needed may reduce the incidence of NAF failure according to nonrandomized studies. The aim of this randomized study was to determine whether an interventional strategy consisting of clinical and duplex ultrasonographic (DUS) surveillance of NAFs followed by PTA reduces the rate of the need of central venous dialysis catheters (CVCs) and NAF thrombosis in patients undergoing HD. METHODS: A total of 108 patients with 111 functioning NAFs in an HD program were randomized to control and interventional strategy groups. The control group received standard care: clinical and hemodynamic NAF assessment followed by vascular surgeon consultation in cases of dysfunction. In the interventional group, the patients underwent clinical monitoring and systematic DUS surveillance every 3 months. Cases with access dysfunction underwent angiography followed by PTA for stenosis of 50% or greater. Primary outcomes were the need of temporary CVCs and fistula thrombosis. RESULTS: Fifty-eight NAFs were randomized to the control group, and 53 were randomized to the interventional group. Groups had similar baseline characteristics. The interventional strategy showed a significant reduction in the CVC need (25.9% versus 7.5% for control and interventional groups, respectively; P = .021). No significant difference was observed for thrombosis rates (24.1% versus 17.0%; P = .487). The composite end point of NAF thrombosis or CVC need was reduced by the interventional strategy (44.8% versus 20.8%; P = .033). CONCLUSIONS: This randomized study indicates the benefit of a surveillance program for maintenance of NAFs based on clinical and DUS surveillance followed by PTA of major stenosis.

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.

Avaliação Prognóstica da Reserva de Fluxo Fracionada em Diferentes Estratos nos Pacientes com Doença Arterial Coronariana / Prognostic Assessment of Fractional Flow Reserve in Different Strata in Patients with Coronary Artery Disease

Resumo Fundamento Existem dados limitados sobre a evolução clínica de lesões coronarianas não tratadas de acordo com sua gravidade funcional no mundo real. Objetivo Este estudo teve como objetivo avaliar os resultados clínicos de até 5 anos em pacientes com lesões revascularizadas com reserva de fluxo fracionada (FFR) ≤ 0,8 e em pacientes com lesões não revascularizadas com FFR > 0,8. Métodos A avaliação pelo FFR foi realizada em 218 pacientes seguidos por até 5 anos. Os participantes foram classificados com base na FFR no grupo isquêmico (≤ 0,8, grupo intervenção, n = 55), no grupo FFR normal-baixa (> 0,8-0,9, n = 91) e no grupo FFR normal-alta (> 0,9, n = 72). O desfecho primário foram eventos cardíacos adversos maiores (ECAMs), um composto de morte, infarto do miocárdio e necessidade de nova revascularização. O nível de significância adotado neste estudo foi alfa = 0,05; deste modo, resultados com valores de p < 0,05 foram considerados estatisticamente significativos. Resultados A maioria dos participantes era do sexo masculino (62,8%) com média de idade de 64,1 anos. Diabetes estava presente em 27%. À angiografia coronariana, a gravidade da estenose avaliada foi de 62%, 56,4% e 54,3% nos grupos isquêmico, FFR normal-baixa e FFR normal-alta, respectivamente (p < 0,05). O período médio de acompanhamento foi de 3,5 anos. A incidência ECAM foi de 25,5%, 13,2% e 11,1%, respectivamente (p = 0,037). Não houve diferença na incidência de ECAM entre os grupos FFR normal-baixa e FFR normal-alta (p = NS). Conclusão Pacientes com FFR indicativa de isquemia apresentaram piores desfechos quando comparados aos dos grupos não isquêmicos. Entre os grupos que apresentaram valores de FFR considerados normal-baixo e normal-alto, não houve diferença na incidência de eventos. Há necessidade de estudos de longo prazo e com grande número de pacientes para melhor avaliar os desfechos cardiovasculares em pacientes portadores de estenose coronariana moderada com valores de FFR entre 0,8 e 1,0.

Abstract Background There are limited real-world data on the clinical course of untreated coronary lesions according to their functional severity. Objective To evaluate the 5-year clinical outcomes of patients with revascularized lesions with fractional flow reserve (FFR) ≤ 0.8 and patients with non-revascularized lesions with FFR > 0.8. Methods The FFR assessment was performed in 218 patients followed for up to 5 years. Participants were classified based on FFR into ischemia group (≤ 0.8, intervention group, n = 55), low-normal FFR group (> 0.8-0.9, n = 91), and high-normal FFR group (> 0.9, n = 72). The primary endpoint was major adverse cardiac events (MACEs), a composite of death, myocardial infarction, and need for repeat revascularization. The significance level was set at 0.05; therefore, results with a p-value < 0.05 were considered statistically significant. Results Most patients were male (62.8%) with a mean age of 64.1 years. Diabetes was present in 27%. On coronary angiography, the severity of stenosis was 62% in the ischemia group, 56.4% in the low-normal FFR group, and 54.3% in the high-normal FFR group (p<0.05). Mean follow-up was 3.5 years. The incidence of MACEs was 25.5%, 13.2%, and 11.1%, respectively (p=0.037). MACE incidence did not differ significantly between the low-normal and high-normal FFR groups. Conclusion Patients with FFR indicative of ischemia had poorer outcomes than those in non-ischemia groups. There was no difference in the incidence of events between the low-normal and high-normal FFR groups. Long-term studies with a large sample size are needed to better assess cardiovascular outcomes in patients with moderate coronary stenosis with FFR values between 0.8 and 1.0.

Association of alcohol consumption with coronary artery disease severity.

BACKGROUND & AIMS: The ingestion of small to moderate alcohol consumption amounts has been associated to cardiovascular protection. This study aimed to evaluate the association between alcohol consumption and coronary artery disease severity. MATERIAL AND METHODS: Cross-sectional Study with patients undergoing coronary angiography. Age, cardiovascular risk factors (smoking, systemic arterial hypertension, dyslipidemia and diabetes) and alcohol drinking habit were investigated. Alcohol consumption was divided in three categories: nondrinker, moderate alcohol consumption (less than 15 g ethanol/day for women or 30 g ethanol/day for men) and heavy alcohol consumption. Coronary artery disease severity was assessed through the Friesinger Score (FS) in the coronary angiography, by interventional cardiologists blinded to alcohol consumption. RESULTS: The final sample included 363 adults; of those, 228 were men (62.81%). Mean age was 60.5 ± 10.9 y. Unadjusted analyses identified sex, age, hypertension, diabetes, dyslipidemia and alcohol consumption as the main covariates associated with the Friesinger score. Lower Friesinger scores were also observed in moderate alcohol consumption when comparing to those who do not drink (RR 0.86; 95% CI 0.79-0.95). CONCLUSION: Among patients with suspected coronary artery disease undergoing coronary angiography, moderate alcohol consumption is associated to a lower coronary artery disease severity than heavy drinking.