LANDMARK comparison of early outcomes of newer-generation Myval transcatheter heart valve series with contemporary valves (Sapien and Evolut) in real-world individuals with severe symptomatic native aortic stenosis: a randomised non-inferiority trial.

BACKGROUND: Transcatheter aortic valve implantation is an established, guideline-endorsed treatment for severe aortic stenosis. Precise sizing of the balloon-expandable Myval transcatheter heart valve (THV) series with the aortic annulus is facilitated by increasing its diameter in 1·5 mm increments, compared with the usual 3 mm increments in valve size. The LANDMARK trial aimed to show non-inferiority of the Myval THV series compared with the contemporary THVs Sapien Series (Edwards Lifesciences, Irvine, CA, USA) or Evolut Series (Medtronic, Minneapolis, MN, USA). METHODS: In this prospective, multinational, randomised, open-label, non-inferiority trial across 31 hospitals in 16 countries (Germany, France, Sweden, the Netherlands, Italy, Spain, New Zealand, Portugal, Greece, Hungary, Poland, Slovakia, Slovenia, Croatia, Estonia, and Brazil), 768 participants with severe symptomatic native aortic stenosis were randomly assigned (1:1) to the Myval THV or a contemporary THV. Eligibility was primarily decided by the heart team in accordance with 2021 European Society of Cardiology guidelines. As per the criteria of the third Valve Academic Research Consortium, the primary endpoint at 30 days was a composite of all-cause mortality, all stroke, bleeding (types 3 and 4), acute kidney injury (stages 2-4), major vascular complications, moderate or severe prosthetic valve regurgitation, and conduction system disturbances resulting in a permanent pacemaker implantation. Non-inferiority of the study device was tested in the intention-to-treat population using a non-inferiority margin of 10·44% and assuming an event rate of 26·10%. This trial is registered with ClinicalTrials.gov, NCT04275726, and EudraCT, 2020-000137-40, and is closed to new participants. FINDINGS: Between Jan 6, 2021, and Dec 5, 2023, 768 participants with severe symptomatic native aortic stenosis were randomly assigned, 384 to the Myval THV and 384 to a contemporary THV. 369 (48%) participants had their sex recorded as female, and 399 (52%) as male. The mean age of participants was 80·0 years (SD 5·7) for those treated with the Myval THV and 80·4 years (5·4) for those treated with a contemporary THV. Median Society of Thoracic Surgeons scores were the same in both groups (Myval 2·6% [IQR 1·7-4·0] vs contemporary 2·6% [1·7-4·0]). The primary endpoint showed non-inferiority of the Myval (25%) compared with contemporary THV (27%), with a risk difference of -2·3% (one-sided upper 95% CI 3·8, pnon-inferiority<0·0001). No significant difference was seen in individual components of the primary composite endpoint. INTERPRETATION: In individuals with severe symptomatic native aortic stenosis, the Myval THV met its primary endpoint at 30 days. FUNDING: Meril Life Sciences.

Left ventricular and atrial myocardial strain in heart failure with preserved ejection fraction: the evidence so far and prospects for phenotyping strategy.

BACKGROUND: Heart failure with preserved ejection fraction (HFpEF) represents a significant proportion of heart failure cases. Accurate diagnosis is challenging due to the heterogeneous nature of the disease and limitations in traditional echocardiographic parameters. MAIN BODY: This review appraises the application of Global Longitudinal Strain (GLS) and Left Atrial Strain (LAS) as echocardiographic biomarkers in the diagnosis and phenotyping of HFpEF. Strain imaging, particularly Speckle Tracking Echocardiography, offers a superior assessment of myocardial deformation, providing a more detailed insight into left heart function than traditional metrics. Normal ranges for GLS and LAS are considered, acknowledging the impact of demographic and technical factors on these values. Clinical studies have demonstrated the prognostic value of GLS and LAS in HFpEF, especially in predicting cardiovascular outcomes and distinguishing HFpEF from other causes of dyspnea. Nevertheless, the variability of strain measurements and the potential for false-negative results underline the need for careful clinical interpretation. The HFA-PEFF scoring system's integration of these biomarkers, although systematic, reveals gaps in addressing the full spectrum of HFpEF pathology. The combined use of GLS and LAS has been suggested to define HFpEF phenogroups, which could lead to more personalized treatment plans. CONCLUSION: GLS and LAS have emerged as pivotal tools in the non-invasive diagnosis and stratification of HFpEF, offering a promise for tailored therapeutic strategies. Despite their potential, a structured approach to incorporating these biomarkers into standard diagnostic workflows is essential. Future clinical guidelines should include clear directives for the combined utilization of GLS and LAS, accentuating their role in the multidimensional assessment of HFpEF.

Effect of sevoflurane on serum CK-MB levels after percutaneous coronary stent placement: A prospective randomized clinical trial.

OBJECTIVES: Markers of myocardial injury, such as creatine kinase-myocardial band (CK-MB) mass, are elevated in up to 30% of patients undergoing percutaneous coronary intervention (PCI) with stent deployment. This elevation represents myocardial injury that can impact the patient in the long term, including the risk of death. Sevoflurane, an inhaled anesthetic, may have cardioprotective properties that benefit patients undergoing PCI. The primary objective was to compare serum CK-MB mass raise in patients who received sevoflurane to those who received a placebo prior to PCI. METHODS: We enrolled patients with coronary artery disease who were eligible for PCI in a randomized (1:1), double-blind, placebo-controlled trial; patients having experienced acute myocardial infarction within 72 hours and those with saphenous vein graft stenting were excluded. Patients (n = 1254) were randomized to receive sevoflurane (2% inspired fraction) or placebo (oxygen alone) for 30 minutes prior to PCI. Additionally, we compared substantial elevations in CK-MB mass (defined as >5x the upper limit of normal), length of stay in the intensive care unit and in-hospital, and 1-year mortality. RESULTS: Sevoflurane was unable to promote cardioprotection, as determined by CK-MB mass levels (sevoflurane group: 2.52 ± 9.64; control group: 1.84 ± 8.58; P=.32). No effect was noticed on the reduction among patients who (AQ: with?) increase (AQ: increased?) marker levels (prevalence of increase in CK-MB mass greater than the upper limit of normality was 30.8% in the sevoflurane group and 28.9% in the control group; P=.33; 4.6% vs 3.1%, respectively, for increases 5x above the upper limit of normality [P=.21]). CONCLUSIONS: Sevoflurane failed to reduce myocardial injury after PCI. Therefore, its usage should not be routinely recommended.

Viability and Safety of Early Hospital Discharge after Minimalist TAVI in the Brazilian Unified Health System. / Viabilidade e Segurança de Alta Hospitalar Precoce após TAVI com Abordagem Minimalista no SUS.

Central Illustration : Viability and Safety of Early Hospital Discharge after Minimalist TAVI in the Brazilian Unified Health System Results after transcatheter aortic valve implantation with a minimalist approach. CKD: chronic kidney disease; PO: postoperative days; TAVI: transcatheter aortic valve implantation.

Figura Central : Viabilidade e Segurança de Alta Hospitalar Precoce após TAVI com Abordagem Minimalista no SUS Resultados após implante de prótese aórtica por cateter por abordagem minimalista. DRC: doença renal crônica; PO: dias pós-operativos; TAVI: implante por cateter de prótese aórtica.

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

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

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

Ioxaglate Versus IoDixanol for the Prevention of Contrast-Induced Nephropathy: The IDPC Trial.

BACKGROUND: Despite the potential benefits of percutaneous procedures for the assessment and treatment of coronary artery disease, these interventions require the use of iodine contrast, which might lead to contrast-induced nephropathy (CIN) and increased risk of dialysis and major adverse cardiac events (MACE). AIMS: We sought to compare two different iodine contrasts (low vs. iso-osmolar) for the prevention of CIN among high-risk patients. METHODS: This is a single-center, randomized (1:1) trial comparing consecutive patients at high risk for CIN referred to percutaneous coronary diagnostic and/or therapeutic procedures with low (ioxaglate) vs. iso-osmolarity (iodixanol) iodine contrast. High risk was defined by the presence of at least one of the following conditions: age >70 years, diabetes mellitus, non-dialytic chronic kidney disease, chronic heart failure, cardiogenic shock, and acute coronary syndrome (ACS). The primary endpoint was the occurrence of CIN, defined as a >25% relative increase and/or >0.5 mg/dL absolute increase in creatinine (Cr) levels compared with baseline between the 2nd and 5th day after contrast media administration. RESULTS: A total of 2,268 patients were enrolled. Mean age was 67 years. Diabetes mellitus (53%), non-dialytic chronic kidney disease (31%), and ACS (39%) were highly prevalent. The mean volume of contrast media was 89 ml ± 48.6. CIN occurred in 15% of all patients, with no significant difference regarding the type of contrast used (iso = 15.2% vs. low = 15.1%, P>.99). Differences were not observed in specific subgroups such as diabetics, elderly, and ACS patients. At 30-day follow-up, 13 patients in the iso-osmolarity group and 11 in low-osmolarity group required dialysis (P =.8). There were 37 (3.3%) deaths in the iso-osmolarity cohort vs. 29 (2.6%) in the low-osmolarity group (P =.4). CONCLUSION: Among patients at high risk for CIN, the incidence of this complication was 15%, and independent of the use of low- or iso-osmolar contrast.

Sinus of Valsalva Pseudoaneurysm: An Unusual Cause of Complete Heart Block.

We present a case of a young man with complete atrioventricular block and aneurysm of the right sinus of Valsalva penetrating the interventricular septum and causing severe aortic regurgitation. Chest trauma and inflammatory or infectious diseases are potential causes. Bentall-de Bono surgical repair was performed. Anatomopathologic analysis demonstrated fibrosis, hyalinization, and extensive myxoid material. (Level of Difficulty: Beginner.).

Mechanical dispersion is a superior echocardiographic feature to predict exercise capacity in preclinical and overt heart failure with preserved ejection fraction.

BACKGROUND: Heart Failure with Preserved Ejection Fraction (HFpEF) is a syndrome characterized by different degrees of exercise intolerance, which leads to poor quality of life and prognosis. Recently, the European score (HFA-PEFF) was proposed to standardize the diagnosis of HFpEF. Even though Global Longitudinal Strain (GLS) is a component of HFA-PEFF, the role of other strain parameters, such as Mechanical Dispersion (MD), has yet to be studied. In this study, we aimed to compare MD and other features from the HFA-PEFF according to their association with exercise capacity in an outpatient population of subjects at risk or suspected HFpEF. METHODS: This is a single-center cross-sectional study performed in an outpatient population of 144 subjects with a median age of 57 years, 58% females, referred to the Echocardiography and Cardiopulmonary Exercise Test to investigate HFpEF. RESULTS: MD had a higher correlation to Peak VO2 (r=-0.43) when compared to GLS (r=-0.26), MD presented a significant correlation to Ventilatory Anaerobic Threshold (VAT) (r=-0.20; p = 0.04), while GLS showed no correlation (r=-0.14; p = 0.15). Neither MD nor GLS showed a correlation with the time to recover VO2 after exercise (T1/2). In Receiver Operator Characteristic (ROC) analysis, MD presented superior performance to GLS to predict Peak VO2 (AUC: 0.77 vs. 0.62), VAT (AUC: 0.61 vs. 0.57), and T1/2 (AUC: 0.64 vs. 0.57). Adding MD to HFA-PEFF improved the model performance (AUC from 0.77 to 0.81). CONCLUSION: MD presented a higher association with Peak VO2 when compared to GLS and most features from the HFA-PEFF. Adding MD to the HFA-PEFF improved the model performance.

Afterload increase challenge unmasks systolic abnormalities in heart failure with preserved ejection fraction.

BACKGROUND: Provocative maneuvers have the potential to overcome the low sensitivity of resting echocardiography and biomarkers in the detection of heart failure with preserved ejection fraction (HFpEF). We investigate the mechanical response of the left ventricle to an afterload challenge in patients with preclinical and early-stage HFpEF (es-HFpEF). METHODS: Three groups of patients (non-HFpEF - n = 42, pre-HFpEF - n = 43, and es-HFpEF - n = 39) underwent echocardiography at rest and during an afterload challenge induced by handgrip maneuver combined with pneumatic constriction of limbs. RESULTS: Patients in the non-HF group displayed a median ΔLPSS = -4% (IQR: -10%, +2%), LPSS rest<16% in 3/42(7%) and LPSS stress<16% in 6/43(14%). Subjects in the pre-HFpEF group displayed median ΔLPSS = -3% (IQR: -10%, +5%) LPSS rest<16% in 13/43(30%) and LPSS stress<16% in 19/43 (44%). 11/43 (25%) subjects in this group increased at least one absolute point in LPSS during stress. Patients in es-HFpEF group displayed a median ΔLPSS = -10% (IQR: -18%, -1%), LPSS rest<16% in 15/39(38%) and LPSS stress<16% in 25/39(64%). Changes in LPSS (ΔLPSS) were significantly greater in es-HFpEF than pre-HFpEF (p = 0.022). In multivariate analysis, this group effect was maintained after adjustment of the LPSS for systolic blood pressure, use of ß-blockers, LV mass, RWT, age, and sex. CONCLUSION: Our data suggest that patients with HFpEF have a marked decrease in peak strain during acute pressure overload. Longitudinal studies are needed to test and compare the clinical impact of each pattern in early and long-term follow-ups.

Serial Assessment of Coronary Artery Healing of a Biodegradable Polymer Drug-Eluting Stent at 1, 2, and 3 Months by Optical Coherence Tomography (OCT)-The REPAIR Trial.

BACKGROUND: Although first-generation drug-eluting stent (DES) devices have effectively achieved their main goal of reducing restenosis, their safety has been limited by suboptimal polymer biocompatibility, delayed stent endothelialization, and local drug toxicity, which ultimately prompted the development of new-generation DES options carrying biocompatible or even biodegradable polymers. AIMS: We sought to assess the vessel-healing pattern of the novel sirolimus-eluting Inspiron DES (Scitech Medical) using serial optical coherence tomography (OCT) and assuming the hypothesis that this thin-strut (75-µm), biodegradable-polymer DES promotes a faster healing, with very early strut coverage. METHODS: This is a prospective, multicenter, open-label, single-arm study enrolling 68 patients who underwent percutaneous coronary intervention guided by OCT. These patients were consecutively assigned into 3 groups. The first group had its OCT imaging follow-up performed at 3 months, the second group at 2 months, and the third group at 1 month. RESULTS: Mean age was 59.5 years, 70.6% were male, 41.2% had type 2 diabetes, and 29.4% presented with acute coronary syndrome. A total of 72 lesions were treated and 1.06 stents were implanted per patient. OCT assessment of the stents at 1, 2, and 3 months showed a strut coverage of 90.41%, 93.96%, and 97.21%, respectively (P=.04). CONCLUSION: The Inspiron DES showed an early strut healing pattern, with >90% of the struts covered by neointima within the first month and with almost all struts covered by the third month.

Effect of randomized prophylactic nitroglycerin on radial artery spasm during transradial catheterization: An analysis based on operator experience.

One limitation to transradial access (TRA) is the occurrence of spasms (RAS), for which the use of prophylactic medications is recommended. Improvement in TRA material combined with the increase in operators' expertise, might mitigate this benefit. We assess the effect of preventive nitroglycerin on RAS during TRA, evaluating the role of the operator's experience. Patients received 500 µg nitroglycerin or placebo. The operator's expertise was classified as: inexperienced (I), intermediate (M), and experienced (E). 2040 patients were included. Prophylactic use of nitroglycerin did not reduce RAS (10.8% vs. 13.4% (placebo), p = 0.07). RAS incidence was 14.5% in I, 12.5% in M, and 9.7% in E (p = 0.01). In group I, nitroglycerin reduced RAS (17.4% vs. 11.1%, p = 0.04), which was not observed in other groups. Overall, nitroglycerin does not prevent RAS, which is more common among inexperienced operators. More experienced operators could abolish preventive nitroglycerin use.

Dual antiplatelet therapy duration after percutaneous coronary intervention in high bleeding risk: a meta-analysis of randomized trials.

AIMS: The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in patients at high bleeding risk (HBR) is still debated. The current study, using the totality of existing evidence, evaluated the impact of an abbreviated DAPT regimen in HBR patients. METHODS AND RESULTS: A systematic review and meta-analysis was performed to search randomized clinical trials comparing abbreviated [i.e. very-short (1 month) or short (3 months)] with standard (≥6 months) DAPT in HBR patients without indication for oral anticoagulation. A total of 11 trials, including 9006 HBR patients, were included. Abbreviated DAPT reduced major or clinically relevant non-major bleeding [risk ratio (RR): 0.76, 95% confidence interval (CI): 0.61-0.94; I2 = 28%], major bleeding (RR: 0.80, 95% CI: 0.64-0.99, I2 = 0%), and cardiovascular mortality (RR: 0.79, 95% CI: 0.65-0.95, I2 = 0%) compared with standard DAPT. No difference in all-cause mortality, major adverse cardiovascular events, myocardial infarction, or stent thrombosis was observed. Results were consistent, irrespective of HBR definition and clinical presentation. CONCLUSION: In HBR patients undergoing PCI, a 1- or 3-month abbreviated DAPT regimen was associated with lower bleeding and cardiovascular mortality, without increasing ischaemic events, compared with a ≥6-month DAPT regimen. STUDY REGISTRATION: PROSPERO registration number CRD42021284004.

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

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

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

Efeito da nitroglicerina no espasmo e na oclusão da artéria radial em cateterismos transradiais realizados em mulheres / Effect of nitroglycerin on radial artery spasm and occlusion in transradial catheterizations performed in women

Introdução: O benefício do cateterismo transradial já foi confirmado em pacientes do sexo feminino. Mulheres submetidas a exames por cateterismo transradial apresentam desafios únicos. A ocorrência de espasmo e oclusão da artéria radial após o procedimento é maior em mulheres. Objetivamos avaliar o benefício da nitroglicerina na redução de espasmo e oclusão da artéria radial em mulheres submetidas a cateterismo transradial. Métodos: Estudo multicêntrico, prospectivo, randomizado 2x2 fatorial, duplo-cego. Participantes foram randomizados para nitroglicerina 500mcg ou placebo em dois momentos: após colocação do introdutor hemostático e antes da retirada. A avaliação de espasmo da artéria radial foi clínica, por meio de escala dor. A avaliação da oclusão da artéria radial foi realizada com Doppler, nas primeiras 12 horas. Resultados: Foram incluídos 2.040 pacientes, sendo 774 (37,5%) mulheres. A média de idade foi similar entre os sexos (62,2 anos versus 61,5 anos; p=0,27). A incidência de espasmo da artéria radial foi maior nas mulheres (21,2% versus 6,6%; p<0,01), bem como a incidência de oclusão da artéria radial (3,4% versus 1,8%; p=0,03). O uso da nitroglicerina no início do procedimento não reduziu a incidência de espasmo da artéria radial em mulheres quando comparado com o placebo (19,7% versus 22,6%; p=0,34), tampouco as taxas de oclusão da artéria radial (4,3% versus 2,5%; p=0,17). O uso da nitroglicerina ao fim do procedimento não reduziu a incidência de oclusão da artéria em mulheres (2,8% versus 3,9%; p=0,37). Conclusões: O espasmo e a oclusão da artéria radial são mais frequentes em mulheres submetidas a cateterismo transradial quando comparadas aos homens. O uso da nitroglicerina não apresenta efeito benéfico na redução dessas incidências.

Background: The benefit of transradial catheterization is well established in female patients. Women undergoing transradial catheterization exams present with unique challenges. The occurrence of radial artery spasm and occlusion after the procedure is higher in women. The objective of this study was to evaluate the benefit of nitroglycerin in reducing radial artery spasm and occlusion in women undergoing transradial catheterization. Methods: This was a 2x2 factorial randomized, multicenter, prospective, double-blinded study. Participants were randomized to nitroglycerin 500mcg or placebo at two time points: after placement of the hemostatic introducer and before its removal. The evaluation of the radial artery spasm was clinical, using a pain scale The evaluation of the radial artery occlusion was performed with Doppler, in the first 12 hours. Results: A total of 2,040 patients were included, of which 774 (37.5%) were female. Mean age was similar between sexes (62.2 years versus 61.5 years; p=0.27). The incidence of radial artery spasm was higher in women (21.2% versus 6.6%; p<0.01), as well as the incidence of radial artery occlusion (3.4% versus 1.8%; p=0.03). The use of nitroglycerin at the beginning of the procedure did not reduce the incidence of radial artery spasm in women when compared with placebo (19.7% versus 22.6%; p=0.34), nor did the rates of radial artery occlusion (4.3% versus 2.5%; p=0.17). The use of nitroglycerin at the end of the procedure did not reduce the incidence of artery occlusion in women (2.8% versus 3.9%; p=0.37). Conclusions: Radial artery spasm and occlusion are more frequent in women undergoing transradial catheterization when compared to men. The use of nitroglycerin does not have a beneficial effect in reducing these incidences.

Case-fatality rate of major bleeding events in patients on dual antiplatelet therapy after percutaneous coronary intervention: A systematic review and meta-analysis.

Background: Assessment of the case-fatality rate (CFR) of major bleeding on dual antiplatelet therapy (DAPT) may improve balancing risks and benefits of different durations of DAPT following percutaneous coronary intervention (PCI). Objectives: To determine the CFR of major bleeding in patients on DAPT after PCI and to compare rates among different durations of DAPT. Methods: Medline, Embase, and CENTRAL were searched from inception to August 2021 for randomized trials that reported fatal bleeding among patients who were randomized to ≥1 month of DAPT following PCI. Summary estimates for CFRs of major bleeding were calculated using the random-effects inverse-variance method. Statistical heterogeneity was evaluated using the I 2 statistic. Results: Of 2777 citations obtained by the search, 15 (48%) of 31 potentially eligible studies were excluded because fatal bleeding was not reported, leaving 16 studies that were included in the analysis. Overall, there were 823 major bleeding events including 91 fatal events in 48,884 patients who were assigned to receive DAPT during study follow-up. The CFR of major bleeding was 10.8% (95% confidence interval [CI], 7.1-16.2; I 2 = 50%) in the entire study population, and 13.8% (95% CI, 6.5-27.1; I 2 = 28%), 11.2% (95% CI, 6.7-18.0; I 2 = 0%), and 5.8% (95% CI, 3.0-11.1; I 2 = 0%) in those on short-term (≤6 months; n = 16,553), standard-term (12 months; n = 19,453), and long-term DAPT (>12 months; n = 10,238), respectively. Conclusion: Fatal bleeding is not reported in many studies evaluating DAPT after PCI. The CFR of major bleeding on DAPT is substantial and may be higher in the first 12 months of DAPT than during long-term DAPT.

Randomized Clinical Trial on Prevention of Radial Occlusion After Transradial Access Using Nitroglycerin: PATENS Trial.

OBJECTIVES: The aim of this study was to evaluate whether administration of nitroglycerin at the beginning or end of a transradial approach (TRA) procedure would preserve radial patency. BACKGROUND: The TRA is becoming the preferred vascular access route in coronary interventions. Radial artery occlusion (RAO) is the most frequent complication. Routine vasodilator treatment aims to reduce spasm and possibly prevent RAO. METHODS: The authors designed a prospective, multicenter, randomized, double-blind, 2-by-2 factorial, placebo-controlled trial encompassing patients undergoing the TRA. Patients were randomized to either 500 µg nitroglycerin or placebo; each arm was also subrandomized to early (upon sheath insertion) or late (right before sheath removal) nitroglycerin administration to evaluate the superiority of nitroglycerin in the prevention of RAO with 24 hours on Doppler ultrasound. RESULTS: A total of 2,040 patients were enrolled. RAO occurred in 49 patients (2.4%). Fifteen of these patients (30.6%) showed re-establishment of flow at 30 days. Nitroglycerin, compared with placebo, did not reduce the risk for RAO at either of the 2 time points (early, 2.5% vs 2.3% [P = 0.66]; late, 2.3% vs 2.5% [P = 0.66]). By multivariable analysis, the presence of spasm (OR: 3.53; 95% CI: 1.87-6.65; P < 0.001) and access achieved with more than 1 puncture attempt (OR: 2.58; 95% CI: 1.43-4.66; P = 0.002) were independent predictors of RAO. CONCLUSIONS: The routine use of nitroglycerin was not associated with a reduction in the rate of RAO, regardless of the time of administration (at the beginning or end of the TRA procedure).

Risk-Benefit of 1-Year DAPT After DES Implantation in Patients Stratified by Bleeding and Ischemic Risk.

BACKGROUND: Although a 1-year duration of dual antiplatelet therapy (DAPT) is used in many patients after drug-eluting stent (DES) implantation, the evidence supporting this duration is uncertain. OBJECTIVES: The authors investigated the risk-benefit profile of 1-year vs ≤6-month DAPT after DES using 2 novel scores to risk stratify bleeding and ischemic events. METHODS: Ischemic and bleeding risk scores were generated from ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents), a multicenter, international, "all-comers" registry that enrolled 8,665 patients treated with DES. The risk-benefit profile of 1-year vs ≤6-month DAPT was then investigated across risk strata from an individual patient data pooled dataset of 7 randomized trials that enrolled 15,083 patients treated with DES. RESULTS: In the derivation cohort, the ischemic score and the bleeding score had c-indexes of 0.76 and 0.66, respectively, and both were well calibrated. In the pooled dataset, no significant difference was apparent in any ischemic endpoint between 1-year and ≤6-month DAPT, regardless of the risk strata. In the overall dataset, there was no significant difference in the risk of clinically relevant bleeding between 1-year and ≤6-month DAPT; however, among 2,508 patients at increased risk of bleeding, 1-year compared with ≤6-month DAPT was associated with greater bleeding (HR: 2.80; 95% CI: 1.12-7.13) without a reduced risk of ischemic events in any risk strata, including those with acute coronary syndromes. These results were consistent in a network meta-analysis. CONCLUSIONS: In the present large-scale study, compared with ≤6-month DAPT, a 1-year duration of DAPT was not associated with reduced adverse ischemic events in any risk strata (including acute coronary syndromes) but was associated with greater bleeding in patients at increased risk of bleeding.