RESUMO
BACKGROUND: The optimal antithrombotic strategy early after aortic valve replacement surgery with a biological valve remains controversial due to lack of high-quality evidence. Either oral anticoagulants or acetylsalicylic acid should be considered for the first 3 months. Hypo-attenuated leaflet thickening on cardiac computed tomography has been associated with latent bioprosthetic valve thrombosis and may be prevented with anticoagulation. We hypothesize that anticoagulation with apixaban is superior to single antiplatelet therapy with acetylsalicylic acid in reducing hypo-attenuated leaflet thickening of bioprosthetic aortic valve prostheses. METHODS: In this prospective, open-label, randomized trial, patients undergoing isolated aortic valve replacement surgery with rapid deployment bioprosthetic valves will be randomized. The treatment group will receive 5 mg of apixaban twice a day for the first 3 months and 100 mg of acetylsalicylic acid thereafter. The control group will be administered 100 mg of acetylsalicylic acid once a day, indefinitely. After the 3-month treatment period, a contrast-enhanced electrocardiogram-gated cardiac computed tomography will be performed to identify hypo-attenuated leaflet thickening of the bioprosthetic valve. The primary objective of the study is to assess the impact of apixaban on the prevention of hypo-attenuated leaflet thickening at 3 months. The secondary and exploratory endpoints will be clinical outcomes and safety profiles of the two strategies. DISCUSSION: Antithrombotic therapy after aortic valve replacement is used to prevent valve thrombosis and systemic thromboembolism. Latent bioprosthetic valve thrombosis is a precursor of clinically significant prosthetic valve dysfunction or thromboembolic events. The hallmark feature of latent bioprosthetic valve thrombosis is hypo-attenuated leaflet thickening on cardiac computed tomography. Subclinical leaflet thrombosis occurs frequently in bioprosthetic aortic valves, more commonly in transcatheter than in surgical valves. There is no evidence on the effect of direct oral anticoagulants on the incidence of hypo-attenuated leaflet thickening after surgical aortic valve replacement with rapid deployment bioprostheses. TRIAL REGISTRATION: ClinicalTrials.gov NCT06184113. Registered on December 28, 2023.
Assuntos
Valva Aórtica , Aspirina , Inibidores do Fator Xa , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Valva Aórtica/cirurgia , Valva Aórtica/diagnóstico por imagem , Aspirina/administração & dosagem , Aspirina/uso terapêutico , Aspirina/efeitos adversos , Bioprótese , Inibidores do Fator Xa/administração & dosagem , Inibidores do Fator Xa/efeitos adversos , Inibidores do Fator Xa/uso terapêutico , Fibrinolíticos/administração & dosagem , Fibrinolíticos/efeitos adversos , Próteses Valvulares Cardíacas/efeitos adversos , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/instrumentação , Implante de Prótese de Valva Cardíaca/métodos , Inibidores da Agregação Plaquetária/administração & dosagem , Inibidores da Agregação Plaquetária/uso terapêutico , Inibidores da Agregação Plaquetária/efeitos adversos , Estudos Prospectivos , Pirazóis/uso terapêutico , Pirazóis/administração & dosagem , Pirazóis/efeitos adversos , Piridonas/uso terapêutico , Piridonas/administração & dosagem , Piridonas/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Trombose/prevenção & controle , Trombose/etiologia , Fatores de Tempo , Resultado do TratamentoRESUMO
Penetrating cardiac injuries are rare but are one of the most urgent emergencies because they require early intervention in order to prevent death. The mortality rate of such injuries, including pre-hospitalization deaths, goes up to 90%. The most commonly injured heart chamber is the right ventricle since it takes over half of the anterior thoracic wall. The left ventricle is injured less often, but these patients usually have worse prognoses and higher mortality rates because such injuries lead to hemodynamic instability faster. We present a unique case of a suicide attempt in which the patient stabbed himself with a knife, penetrated the left ventricle, and survived even though he transected the second diagonal branch of the left anterior descending coronary artery and pulled the knife out of his chest.
RESUMO
BACKGROUND: Uterine leiomyosarcoma is a rare and aggressive tumour with a poor prognosis. Its metastases to the heart are even rarer, especially to the epicardium. The majority of reported cardiac metastases of uterine leiomyosarcoma were in the cardiac chambers or intramyocardial. Surgical resection of the uterine leiomyosarcoma in the early stages is the only definitive treatment for this disease. However, in the cases of cardiac metastasis, surgery is recommended only in emergencies and patients with expected beneficial outcomes. CASE PRESENTATION: Our patient was a 49-year-old female referred to the Department of Cardiac Surgery for scheduled surgery of pericardial neoplasia. The patient underwent a hysterectomy and adnexectomy three years prior owing to the uterine leiomyosarcoma. A regular follow-up magnetic resonance imaging of the abdomen and pelvis discovered neoplasia in the diaphragmic portion of the pericardium. No other signs of primary disease relapse or metastases were found. The patient was asymptomatic. The multidisciplinary team concluded that the patient is a candidate for surgery. Surgery included diastolic cardiac arrest achievement and resection of the tumour. Macroscopically, a parietal layer of the pericardium was completely free from the tumour that invaded only the apical myocardium of the left ventricle. Completed histopathology confirmed the diagnosis of leiomyosarcoma of the uterine origin. Three months after surgery, the patient received adjuvant chemotherapy with doxorubicin and dacarbazine. One year after surgery, there are no signs of new metastases. CONCLUSIONS: Strict surveillance of patients with uterine leiomyosarcoma after successful treatment of the early stage of the disease is of utmost importance to reveal metastatic disease to the heart in a timely manner and to treat it with beneficial outcomes. Surgery with adjuvant chemotherapy might be a good approach in patients with a beneficial prognosis. From a surgical point of view, it is challenging to assess the appropriate width of the resection edges to be radical enough and, at the same time, sufficiently conservative to ensure the satisfactory postoperative function of the remaining myocardium and avoid repetitive tumour growth. Therefore, intraoperative histopathology should always be performed.
Assuntos
Leiomiossarcoma , Neoplasias Uterinas , Feminino , Humanos , Pessoa de Meia-Idade , Leiomiossarcoma/diagnóstico por imagem , Leiomiossarcoma/cirurgia , Recidiva Local de Neoplasia/cirurgia , Neoplasias Uterinas/diagnóstico por imagem , Neoplasias Uterinas/cirurgia , Histerectomia , Pericárdio/diagnóstico por imagem , Pericárdio/cirurgia , Pericárdio/patologiaRESUMO
Herein we present the right ventricular dissection and describe its successful management after arterial switch operation in a full-term male neonate. There are no evidence-based recommendations for the management of this rare complication. Our management included veno-arterial extracorporeal membrane oxygenation placement and delayed surgical evacuation of the dissecting haematoma with beneficial outcomes.
Assuntos
Transposição das Grandes Artérias , Oxigenação por Membrana Extracorpórea , Transposição dos Grandes Vasos , Recém-Nascido , Humanos , Masculino , Transposição das Grandes Artérias/efeitos adversos , Transposição dos Grandes Vasos/complicações , Ventrículos do Coração/cirurgia , DissecaçãoRESUMO
This case report discusses a finding of blood in the pericardiocentesis catheter of a patient with a recent history of aortic valve replacement and recurrent postsurgical pericardial and pleural effusions.
Assuntos
Tamponamento Cardíaco , Derrame Pericárdico , Humanos , Idoso , Pericardiocentese , Derrame Pericárdico/cirurgia , Tamponamento Cardíaco/cirurgia , CatéteresRESUMO
A 44-year-old female patient with chemotherapy-induced cardiomyopathy presented with acute cardiogenic shock requiring ECMO support. Multiple failed weaning trials from temporary mechanical circulatory assistance prompted a transition to staged durable biventricular support. Her course was complicated with recurrent RVAD stoppages. The initial event was treated with pump exchange, while for the subsequent RVAD standstill, we employed a device wash-out and reimplantation strategy. A brief period of circulatory arrest was employed to explore the right-sided cardiac chambers using a single-use bronchoscope.
Assuntos
Dextrocardia , Parada Cardíaca , Coração Auxiliar , Humanos , Feminino , Adulto , Choque CardiogênicoRESUMO
A 47-year old male with ischaemic cardiomyopathy was referred to us for durable left ventricular assist device placement. He was found to have prohibitively elevated pulmonary vascular resistance for heart transplantation. He underwent HeartMate 3 left ventricular assist device implantation, with additional temporary right ventricular assist device (RVAD) placement. Following a 2-week period of unweanable temporary right ventricular support, the patient was switched to durable biventricular support with two Heartmate 3 pumps. The patient was placed on a transplant waiting list but was not offered a heart for over 4 years. While on Heartmate 3 biventricular support (BiVAD), he returned to full activity and enjoyed an excellent quality of life. He underwent laparoscopic cholecystectomy 7 months after the BIVAD implant. After 52 months of uneventful BiVAD support, he presented with a combination of adverse events that occurred over a short period. These included subarachnoidal haemorrhage and a new motor deficit, followed by RVAD infection and RVAD low-flow alarms. After over 4 years of unimpeded RVAD flows, new imaging revealed an outflow graft twist with subsequent flow reduction. The patient underwent heart transplantation after a total of 1655 days of Heartmate 3 BiVAD support and continues to do well on latest follow-up.
Assuntos
Insuficiência Cardíaca , Transplante de Coração , Coração Auxiliar , Masculino , Humanos , Pessoa de Meia-Idade , Insuficiência Cardíaca/cirurgia , Insuficiência Cardíaca/etiologia , Qualidade de Vida , Coração Auxiliar/efeitos adversos , Complicações Pós-Operatórias/etiologiaRESUMO
Endomyocardial biopsies are the gold standard for surveillance of graft rejection following heart transplantation, and are assessed by classical histopathology using a limited number of previously stained slices from several biopsies. Synchrotron propagation-based X-ray phase contrast imaging is a non-destructive method to image biological samples without tissue preparation, enabling virtual 2D and 3D histopathology. We aimed to show the feasibility of this method to assess acute cellular rejection and its agreement to classical histopathology. Right ventricular biopsies were sampled from 23 heart transplantation recipients (20 males, mean age 54±14 years) as part of standard follow-up. The clinical diagnosis of potential rejection was made using classical histopathology. One additional study sample was harvested and imaged by X-ray phase contrast imaging, producing 3D datasets with 0.65 µm pixel size, and up to 4,320 images per sample. An experienced pathologist graded both histopathological and X-ray phase contrast images in a blinded fashion. The agreement between methods was assessed by weighted kappa, showing substantial agreement (kappa up to 0.80, p < 0.01) between X-ray phase contrast imaging and classical histopathology. X-ray phase contrast imaging does not require tissue processing, allows thorough analysis of a full myocardial sample and allows identification of acute cellular rejection.
Assuntos
Transplante de Coração , Masculino , Humanos , Adulto , Pessoa de Meia-Idade , Idoso , Seguimentos , Raios X , Biópsia , Rejeição de Enxerto/diagnóstico por imagem , Rejeição de Enxerto/patologia , Imageamento TridimensionalRESUMO
AIMS: Data on sex and left ventricular assist device (LVAD) utilization and outcomes have been conflicting and mostly confined to US studies incorporating older devices. This study aimed to investigate sex-related differences in LVAD utilization and outcomes in a contemporary European LVAD cohort. METHODS AND RESULTS: This analysis is part of the multicentre PCHF-VAD registry studying continuous-flow LVAD patients. The primary outcome was all-cause mortality. Secondary outcomes included ventricular arrhythmias, right ventricular failure, bleeding, thromboembolism, and the haemocompatibility score. Multivariable Cox regression models were used to assess associations between sex and outcomes. Overall, 457 men (81%) and 105 women (19%) were analysed. At LVAD implant, women were more often in Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1 or 2 (55% vs. 41%, P = 0.009) and more often required temporary mechanical circulatory support (39% vs. 23%, P = 0.001). Mean age was comparable (52.1 vs. 53.4 years, P = 0.33), and median follow-up duration was 344 [range 147-823] days for women and 435 [range 190-816] days for men (P = 0.40). No significant sex-related differences were found in all-cause mortality (hazard ratio [HR] 0.79 for female vs. male sex, 95% confidence interval [CI] [0.50-1.27]). Female LVAD patients had a lower risk of ventricular arrhythmias (HR 0.56, 95% CI [0.33-0.95]) but more often experienced right ventricular failure. No significant sex-related differences were found in other outcomes. CONCLUSIONS: In this contemporary European cohort of LVAD patients, far fewer women than men underwent LVAD implantation despite similar clinical outcomes. This is important as the proportion of female LVAD patients (19%) was lower than the proportion of females with advanced HF as reported in previous studies, suggesting underutilization. Also, female patients were remarkably more often in INTERMACS profile 1 or 2, suggesting later referral for LVAD therapy. Additional research in female patients is warranted.
Assuntos
Insuficiência Cardíaca , Coração Auxiliar , Humanos , Masculino , Feminino , Coração Auxiliar/efeitos adversos , Resultado do Tratamento , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/terapia , Sistema de RegistrosRESUMO
BACKGROUND: Diabetic patients tend to have increased platelet reactivity after coronary artery bypass grafting (CABG). The aim of this study was to determine the association between hemoglobin A1c (HbA1c) values and platelet reactivity and to evaluate the consequent impact on clinical outcomes in patients undergoing CABG. METHODS: This prospective observational trial consecutively enrolled 225 diabetic patients undergoing CABG, between February 2014 and October 2018. HbA1c levels and platelet function (multiple electrode aggregometry [MEA]) were analyzed the day before surgery and on postoperative day 4 (POD 4). Patients were divided into two groups according to the HbA1c value: HBA1c < 7% and HbA1c ≥ 7%. RESULTS: Significantly higher postoperative ASPI (platelet function test based on arachidonic acid) and ADP (platelet function test based on adenosine diphosphate) test values were observed at POD 4 compared with preoperative values (ASPI test: p < 0.001; ADP test: p < 0.001). The prevalence of preoperative aspirin resistance (AR) was 46.4% relative to 57.2% after surgery showing consistent increase in postoperative AR by approximately 10%. In addition, the prevalence of AR in the HbA1c < 7% group was higher by 10% compared with the HbA1c ≥ 7% group, both before and after surgery. We did not demonstrate differences in clinical outcomes between the HbA1c groups. CONCLUSION: Perioperative assessment of platelet reactivity in diabetic patients detects those with AR who may be at increased risk of adverse ischemic events. A personalized approach guided by MEA and administration of early and more potent antiaggregation therapy after CABG can be beneficial in this group of patients.
Assuntos
Plaquetas , Diabetes Mellitus , Humanos , Inibidores da Agregação Plaquetária , Hemoglobinas Glicadas , Aspirina , Agregação Plaquetária , Resultado do Tratamento , Ponte de Artéria Coronária/efeitos adversos , Difosfato de Adenosina/farmacologiaRESUMO
AIMS: Use of left ventricular assist devices (LVADs) in older patients has increased, and assessing outcomes in older LVAD recipients is important. Therefore, this study aimed to investigate associations between age and outcomes after continuous-flow LVAD (cf-LVAD) implantation. METHODS AND RESULTS: Cf-LVAD patients from the multicentre European PCHF-VAD registry were included and categorized into those <50, 50-64, and ≥65 years old. The primary endpoint was all-cause mortality. Among secondary outcomes were heart failure (HF) hospitalizations, right ventricular (RV) failure, haemocompatibility score, bleeding events, non-fatal thromboembolic events, and device-related infections. Of 562 patients, 184 (32.7%) were <50, 305 (54.3%) were aged 50-64, whereas 73 (13.0%) were ≥65 years old. Median follow-up was 1.1 years. Patients in the oldest age group were significantly more often designated as destination therapy (DT) candidates (61%). A 10 year increase in age was associated with a significantly higher risk of mortality (hazard ratio [HR] 1.34, 95% confidence interval [CI] [1.15-1.57]), intracranial bleeding (HR 1.49, 95% CI [1.10-2.02]), and non-intracranial bleeding (HR 1.30, 95% CI [1.09-1.56]), which was confirmed by a higher mean haemocompatibility score (1.37 vs. 0.77, oldest vs. youngest groups, respectively, P = 0.033). Older patients suffered from less device-related infections requiring systemic antibiotics. No age-related differences were observed in HF-related hospitalizations, ventricular arrhythmias, pump thrombosis, non-fatal thromboembolic events, or RV failure. CONCLUSIONS: In the PCHF-VAD registry, higher age was associated with increased risk of mortality, and especially with increased risk of major bleeding, which is particularly relevant for the DT population. The risks of HF hospitalizations, pump thrombosis, ventricular arrhythmia, or RV failure were comparable. Strikingly, older patients had less device-related infections.
Assuntos
Insuficiência Cardíaca , Coração Auxiliar , Trombose , Humanos , Idoso , Coração Auxiliar/efeitos adversos , Resultado do Tratamento , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/terapia , Arritmias Cardíacas , Sistema de Registros , Trombose/etiologiaRESUMO
Despite advances in medical therapy and mechanical circulatory support (MCS), heart transplant (HT) remains the gold standard therapy for end-stage heart failure. Patients in cardiogenic shock require prompt intervention to reverse hypoperfusion and end-organ damage. When medical therapy becomes insufficient, MCS should be considered. Historically, it has been reported that critically ill patients bridged with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) directly to HT have worse outcomes. However, when the heart allocation system gives the highest priority to patients on VA-ECMO support, those patients have a higher incidence of HT and a lower incidence of death or removal from the transplant list. Moreover, patients with a short waiting time on VA-ECMO have a similar hazard of mortality to non-ECMO patients. According to the reported data, bridging with VA-ECMO directly to HT may be a solution in the selection of critically ill patients when the anticipated waiting list time is short. However, when a prolonged waiting time is expected, more durable MCS should be considered. Regardless of the favorable results of the direct bridging to HT with ECMO in selected patients, the superiority of this strategy compared to the bridge-to-bridge strategy (ECMO to durable MCS) has not been established and further studies are mandatory in order to clarify this issue.
RESUMO
AIM: To evaluate the impact of minimally invasive aortic valve replacement (mini-AVR) on clinical outcomes in comparison with the gold standard. METHODS: We retrospectively reviewed the records of all patients who underwent isolated AVR at the University Hospital Center Zagreb from 2010 to 2020. Patients undergoing mini-AVR were compared with patients undergoing conventional AVR (fs-AVR). The primary outcome measure was blood product consumption. Propensity score matching was used to create a balanced covariate distribution across treatment groups. Additionally, we compared the contemporary outcomes with a historical control. RESULTS: The final sample consisted of 1088 patients. In the unmatched cohorts, mini-AVR patients were younger (65±12 vs 68±10 years, P<0.001) and had lower risk profiles (EuroSCORE2 2.8±2.0 vs 3.5±3.1, P=0.003). After matching, mini-AVR patients required less blood transfusion than fs-AVR patients (270 [0-790] vs 510 [0-970] mL, P=0.029). The incidences of stroke, dialysis, new AV block, and mortality were comparable. Cross-clamp times were longer in the mini-AVR group (71 [60-87] vs 66 [53-83] minutes, P=0.013). Outcomes were improved in the contemporary mini-AVR era compared with our early mini-AVR experience across multiple metrics. Blood product consumption was reduced in the latter tercile of experience (0 [0-520] vs 500 [0-1018] mL, P<0.001), and the operation was performed more expeditiously (cross-clamp times: 63 [54,80] vs 74 [62,88] minutes, P<0.001) in comparison with earlier periods. CONCLUSIONS: We showed that mini-AVR was associated with less blood product requirement than conventional surgery. Our data supports wider adoption of minimally invasive techniques in dedicated centers of excellence.
Assuntos
Valva Aórtica , Implante de Prótese de Valva Cardíaca , Humanos , Valva Aórtica/cirurgia , Pontuação de Propensão , Implante de Prótese de Valva Cardíaca/métodos , Estudos Retrospectivos , Esternotomia/métodos , Resultado do Tratamento , Procedimentos Cirúrgicos Minimamente Invasivos/métodosRESUMO
Aortic regurgitation (AR) following continuous flow left ventricular assist device implantation (cf-LVAD) may adversely impact outcomes. We aimed to assess the incidence and impact of progressive AR after cf-LVAD on prognosis, biomarkers, functional capacity and echocardiographic findings. In an analysis of the PCHF-VAD database encompassing 12 European heart failure centers, patients were dichotomized according to the progression of AR following LVAD implantation. Patients with de-novo AR or AR progression (AR_1) were compared to patients without worsening AR (AR_0). Among 396 patients (mean age 53 ± 12 years, 82% male), 153 (39%) experienced progression of AR over a median of 1.4 years on LVAD support. Before LVAD implantation, AR_1 patients were less frequently diabetic, had lower body mass indices and higher baseline NT-proBNP values. Progressive AR did not adversely impact mortality (26% in both groups, HR 0.91 [95% CI 0.61-1.36]; P = 0.65). No intergroup variability was observed in NT-proBNP values and 6-minute walk test results at index hospitalization discharge and at 6-month follow-up. However, AR_1 patients were more likely to remain in NYHA class III and had worse right ventricular function at 6-month follow-up. Lack of aortic valve opening was related to de-novo or worsening AR (P < 0.001), irrespective of systolic blood pressure (P = 0.67). Patients commonly experience de-novo or worsening AR when exposed to continuous flow of contemporary LVADs. While reducing effective forward flow, worsening AR did not influence survival. However, less complete functional recovery and worse RV performance among AR_1 patients were observed. Lack of aortic valve opening was associated with progressive AR.
Assuntos
Insuficiência da Valva Aórtica , Insuficiência Cardíaca , Coração Auxiliar , Humanos , Masculino , Adulto , Pessoa de Meia-Idade , Idoso , Feminino , Insuficiência da Valva Aórtica/diagnóstico , Insuficiência da Valva Aórtica/epidemiologia , Insuficiência da Valva Aórtica/etiologia , Coração Auxiliar/efeitos adversos , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/terapia , Insuficiência Cardíaca/complicações , Ecocardiografia , Função Ventricular Direita , Estudos Retrospectivos , Resultado do TratamentoRESUMO
AIMS: Temporal changes in patient selection and major technological developments have occurred in the field of left ventricular assist devices (LVADs), yet analyses depicting this trend are lacking for Europe. We describe the advances of European LVAD programmes from the PCHF-VAD registry across device implantation eras. METHODS AND RESULTS: Of 583 patients from 13 European centres in the registry, 556 patients (mean age 53 ± 12 years, 82% male) were eligible for this analysis. Patients were divided into eras (E) by date of LVAD implantation: E1 from December 2006 to December 2012 (6 years), E2 from January 2013 to January 2020 (7 years). Patients implanted more recently were older with more comorbidities, but less acutely ill. Receiving an LVAD in E2 was associated with improved 1-year survival in adjusted analysis (hazard ratio [HR] 0.58, 95% confidence interval [CI] 0.35-0.98; p = 0.043). LVAD implantation in E2 was associated with a significantly lower chance of heart transplantation (adjusted HR 0.40, 95% CI 0.23-0.67; p = 0.001), and lower risk of LVAD-related infections (adjusted HR 0.64, 95% CI 0.43-0.95; p = 0.027), both in unadjusted and adjusted analyses. The adjusted risk of haemocompatibility-related events decreased (HR 0.60, 95% CI 0.39-0.91; p = 0.016), while heart failure-related events increased in E2 (HR 1.67, 95% CI 1.02-2.75; p = 0.043). CONCLUSION: In an analysis depicting the evolving landscape of continuous-flow LVAD carriers in Europe over 13 years, a trend towards better survival was seen in recent years, despite older recipients with more comorbidities, potentially attributable to increasing expertise of LVAD centres, improved patient selection and pump technology. However, a smaller chance of undergoing heart transplantation was noted in the second era, underscoring the relevance of improved outcomes on LVAD support.
Assuntos
Insuficiência Cardíaca , Transplante de Coração , Coração Auxiliar , Adulto , Idoso , Europa (Continente)/epidemiologia , Feminino , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/terapia , Humanos , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Estudos Retrospectivos , Resultado do TratamentoRESUMO
BACKGROUND: Surgical aortic valve replacement (SAVR) represents a class I indication in symptomatic patients with severe aortic stenosis (AS). However, indications for early SAVR in asymptomatic patients with severe AS and normal left ventricular function remain debated. METHODS: The AVATAR trial (Aortic Valve Replacement Versus Conservative Treatment in Asymptomatic Severe Aortic Stenosis) is an investigator-initiated international prospective randomized controlled trial that evaluated the safety and efficacy of early SAVR in the treatment of asymptomatic patients with severe AS, according to common criteria (valve area ≤1 cm2 with aortic jet velocity >4 m/s or a mean transaortic gradient ≥40 mm Hg), and with normal left ventricular function. Negative exercise testing was mandatory for inclusion. The primary hypothesis was that early SAVR would reduce the primary composite end point of all-cause death, acute myocardial infarction, stroke, or unplanned hospitalization for heart failure compared with a conservative strategy according to guidelines. The trial was designed as event-driven to reach a minimum of 35 prespecified events. The study was performed in 9 centers in 7 European countries. RESULTS: Between June 2015 and September 2020, 157 patients (mean age, 67 years; 57% men) were randomly allocated to early surgery (n=78) or conservative treatment (n=79). Follow-up was completed in May 2021. Overall median follow-up was 32 months: 28 months in the early surgery group and 35 months in the conservative treatment group. There was a total of 39 events, 13 in early surgery and 26 in the conservative treatment group. In the early surgery group, 72 patients (92.3%) underwent SAVR with operative mortality of 1.4%. In an intention-to-treat analysis, patients randomized to early surgery had a significantly lower incidence of primary composite end point than those in the conservative arm (hazard ratio, 0.46 [95% CI, 0.23-0.90]; P=0.02). There was no statistical difference in secondary end points, including all-cause mortality, first heart failure hospitalizations, major bleeding, or thromboembolic complications, but trends were consistent with the primary outcome. CONCLUSIONS: In asymptomatic patients with severe AS, early surgery reduced a primary composite of all-cause death, acute myocardial infarction, stroke, or unplanned hospitalization for heart failure compared with conservative treatment. This randomized trial provides preliminary support for early SAVR once AS becomes severe, regardless of symptoms. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02436655.