Rationale and design of the Aortic Valve replAcemenT versus conservative treatment in Asymptomatic seveRe aortic stenosis (AVATAR trial): A randomized multicenter controlled event-driven trial

Banović, Marko; Iung, Bernard; Bartúnek, Jozef; Ašanin, Milika; Beleslin, Branko; Biočina, Bojan; Casselman, Filip; Costa, Mark Da; Deja, Marek; Gašparović, Hrvoje; Kala, Petr; Labrousse, L.; Lončar, Zlatibor; Marinković, Jelena; Nedeljković, Ivana; Nedeljković, Milan; Nemec, Peter; Nikolic, Serge; Pencina, Michael J.; Pěnička, Martin; Ristić, Arsen; Sharif, Faisal; Camp, Guy Van; Vanderheyden, Marc; Wojakowski, Wojtek; Putnik, Svetozar

doi:10.1016/j.ahj.2016.02.001

Cited by 54 publications

(31 citation statements)

References 27 publications

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“…AS management is difficult, particularly in asymptomatic patients, with a persistent controversy between conservative treatment and surgical management 17, 18, 19, 20. On the one hand, as reported,21, 22, 23 the 2‐year risk of cardiac events (onset of symptoms, AVR, or mortality) in asymptomatic patients with hemodynamically significant AS is high, whereas the risk of sudden death is low.…”

Section: Discussionmentioning

confidence: 99%

Impact of Mean Transaortic Pressure Gradient on Long‐Term Outcome in Patients With Severe Aortic Stenosis and Preserved Left Ventricular Ejection Fraction

Bohbot

Kowalski

Ruşinaru

et al. 2017

JAHA

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BackgroundMean transaortic pressure gradient (MTPG) has never been validated as a predictor of mortality in patients with severe aortic stenosis. We sought to determine the value of MTPG to predict mortality in a large prospective cohort of severe aortic stenosis patients with preserved left ventricular ejection fraction and to investigate the cutoff of 60 mm Hg, proposed in American guidelines.Methods and ResultsA total of 1143 patients with severe aortic stenosis defined by aortic valve area ≤1 cm2 and MTPG ≥40 mm Hg were included. The population was divided into 3 groups according to MTPG: between 40 and 49 mm Hg, between 50 and 59 mm Hg, and ≥60 mm Hg. The end point was all‐cause mortality. MTPG was ≥60 mm Hg in 392 patients. Patients with MTPG ≥60 mm Hg had a significantly increase risk of mortality compared with patients with MTPG <60 mm Hg (hazard ratio [HR]=1.62 [1.27–2.05] P<0.001), even for the subgroup of asymptomatic or minimally symptomatic patients (HR=1.56 [1.04–2.34] P=0.032). After adjustment for established outcome predictors, patients with MTPG ≥60 mm Hg had a significantly higher risk of mortality than patients with MTPG <60 mm Hg (HR=1.71 [1.33–2.20] P<0.001), even after adjusting for surgery as a time‐dependent variable (HR=1.71 [1.43–2.11] P<0.001). Similar results were observed for the subgroup of asymptomatic or minimally symptomatic patients (HR=1.70 [1.10–2.32] P=0.018 and HR=1.68 [1.20–2.36] P=0.003, respectively).ConclusionsThis study shows the negative prognostic impact of high MTPG (≥60 mm Hg), on long‐term outcome of patients with severe aortic stenosis with preserved left ventricular ejection fraction, irrespective of symptoms.

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Section: Discussionmentioning

confidence: 99%

Impact of Mean Transaortic Pressure Gradient on Long‐Term Outcome in Patients With Severe Aortic Stenosis and Preserved Left Ventricular Ejection Fraction

Bohbot

Kowalski

Ruşinaru

et al. 2017

JAHA

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“…AS management is difficult, particularly in asymptomatic patients, with a persistent controversy between conservative treatment and surgical management. [17][18][19][20] On the one hand, as reported, 21-23 the 2-year risk of cardiac events (onset of symptoms, AVR, or mortality) in asymptomatic patients with hemodynamically significant AS is high, whereas the risk of sudden death is low. Conversely, AVR should ideally be performed before the onset of irreversible left heart remodeling that reduces the long-term benefit of surgery.…”

Section: Discussionmentioning

confidence: 99%

Impact of Mean Transaortic Pressure Gradient on Long-Term Outcome in Patients with Severe Aortic Stenosis and Preserved Left Ventricular Ejection Fraction

Bohbot¹,

Kowalski²,

Ruşinaru³

et al. 2017

Archives of Cardiovascular Diseases Supplements

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Background--Mean transaortic pressure gradient (MTPG) has never been validated as a predictor of mortality in patients with severe aortic stenosis. We sought to determine the value of MTPG to predict mortality in a large prospective cohort of severe aortic stenosis patients with preserved left ventricular ejection fraction and to investigate the cutoff of 60 mm Hg, proposed in American guidelines.Methods and Results--A total of 1143 patients with severe aortic stenosis defined by aortic valve area ≤1 cm 2 and MTPG ≥40 mm Hg were included. The population was divided into 3 groups according to MTPG: between 40 and 49 mm Hg, between 50 and 59 mm Hg, and ≥60 mm Hg. The end point was all-cause mortality. MTPG was ≥60 mm Hg in 392 patients. Patients with MTPG ≥60 mm Hg had a significantly increase risk of mortality compared with patients with MTPG <60 mm Hg (hazard ratio [HR] =1.62 [1.27-2.05] P<0.001), even for the subgroup of asymptomatic or minimally symptomatic patients (HR=1.56 [1.04-2.34] P=0.032). After adjustment for established outcome predictors, patients with MTPG ≥60 mm Hg had a significantly higher risk of mortality than patients with MTPG <60 mm Hg (HR=1.71 [1.33-2.20] P<0.001), even after adjusting for surgery as a timedependent variable (HR=1.71 [1.43-2.11] P<0.001). Similar results were observed for the subgroup of asymptomatic or minimally symptomatic patients (HR=1.70 [1.10-2.32] P=0.018 and HR=1.68 [1.20-2.36] P=0.003, respectively).Conclusions--This study shows the negative prognostic impact of high MTPG (≥60 mm Hg), on long-term outcome of patients with severe aortic stenosis with preserved left ventricular ejection fraction, irrespective of symptoms. ( J Am Heart Assoc. 2017;6: e005850.AS indicates aortic stenosis; MTPG, mean transaortic pressure gradient. *P for global comparison. † Model 1: adjustment for age, sex, body surface area, hypertension, coronary artery disease, history of atrial fibrillation, comorbidity index, and ejection fraction. ‡ Model 2: adjustment for age, sex, body surface area, hypertension, coronary artery disease, history of atrial fibrillation, comorbidity index, ejection fraction, and aortic valve surgery as a time-dependent covariate.

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“…A randomised controlled trial in asymptomatic severe AS is currently underway, and this would add important data that would help define management strategies 19. We would advocate waiting for the results of this trial prior to making firm recommendations for the management of this patient group.…”

Section: Discussionmentioning

confidence: 99%

Meta-analysis of the impact of intervention versus symptom-driven management in asymptomatic severe aortic stenosis

Lim

Ramasamy

Lloyd

2016

Heart

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Objective The management of patients with asymptomatic, severe aortic stenosis (AS) is controversial. We performed a meta-analysis to examine the impact on outcomes of aortic valve replacement (AVR) in patients with severe asymptomatic AS versus a symptom-driven intervention approach. Methods A search for studies that examined the outcomes of AVR and management of asymptomatic severe AS was performed. We examined the end points of all-cause mortality, cardiac mortality and sudden cardiac death. Our analysis compared early AVR in asymptomatic patients with a symptom-driven AVR approach (excluding symptomatic patients who did not undergo AVR).

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Rationale and design of the Aortic Valve replAcemenT versus conservative treatment in Asymptomatic seveRe aortic stenosis (AVATAR trial): A randomized multicenter controlled event-driven trial

Cited by 54 publications

References 27 publications

Impact of Mean Transaortic Pressure Gradient on Long‐Term Outcome in Patients With Severe Aortic Stenosis and Preserved Left Ventricular Ejection Fraction

Impact of Mean Transaortic Pressure Gradient on Long‐Term Outcome in Patients With Severe Aortic Stenosis and Preserved Left Ventricular Ejection Fraction

Impact of Mean Transaortic Pressure Gradient on Long-Term Outcome in Patients with Severe Aortic Stenosis and Preserved Left Ventricular Ejection Fraction

Meta-analysis of the impact of intervention versus symptom-driven management in asymptomatic severe aortic stenosis

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