Incremental prognostic value of multiparametric echocardiographic assessment for severe aortic stenosis

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Journal of Cardiovascular Medicine Implementation of Diagnosis in asymptomatic patiEnts with Aortic Stenosis: the IDEAS registry --Manuscript Draft-Manuscript Number: Full Title:

Implementation of Diagnosis in asymptomatic patiEnts with Aortic Stenosis: the IDEAS registry

Article Type:

Perspective Article

Keywords:

aortic stenosis; aortic valve replacement; echocardiography; aortic valve calcification; diagnostic assessment.

Corresponding Author:

giovanni cioffi, m.d. villa bianca hospital trento, ITALY

Corresponding Author Secondary Information: Corresponding Author's Institution:

villa bianca hospital

Corresponding Author's Secondary Institution: First Author:

giovanni cioffi, m.d.

First Author Secondary Information: Order of Authors:

giovanni cioffi, m.d. andrea rossi, MD stefano nistri pompilio faggiano

Order of Authors Secondary Information: Manuscript Region of Origin:

ITALY

Abstract:

Not infrequently in clinical practice, some physicians refer patients with aortic stenosis (AS) for an invasive approach in the asymptomatic phase of the disease. This empirical behavior, which is in contrast with the recommendations of the current international clinical guidelines, is due to the perception that the prognosis of these patients is truly worse than retained. Actually, the management of asymptomatic patients with AS remains controversial, and there is not a clear agreement on how to reduce excess mortality and morbidity demonstrated in these patients by recent randomized clinical trials. The prevailing attention of the attending physicians is often limited to the assessment of the AS severity and appearance of symptoms, but it has been clearly shown, instead, that the impaired prognosis of these patients, is mainly due to excessive left ventricular (LV) mass growth and increased atherosclerosis leading to coronary artery disease, heart failure, stroke and death. Thus, beside the markers of faster AS progression, many other clinical and echocardiographic variables should be considered, collected and used together with the clinical/echocardiographic prognostic scores recently validated by several authors in clinical practice, where the vast majority of these variables are guiltily not taken into any consideration. The IDEAS registry (registry on the Implementation of Diagnosis in asymptomatic patiEnts with Aortic Stenosis) is a prospective study designed with the aim to improve the diagnostic evaluation and improve the prognostic stratification of patients with asymptomatic AS.

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Cover Letter

Trento, March 8, 2013 To the kind attention of Prof. Livio Dei Cas Chef Editor, Journal of Cardiovscular Medicine Re. : Manuscript submission Category of manuscript: Perspective article Dear Prof Dei Cas Please find enclosed the manuscript entitled “Implementation of Diagnosis in asymptomatic patiEnts with Aortic Stenosis: the IDEAS registry” in order to consider the publication in “Journal of Cardiovascular Medicine “. We accept transfer of all copyright ownership of our manuscript to your Journal, in the event the work is published. We declare that the article is original, does not infringe upon any copyright or other proprietary right of any third party, is not under consideration by another journal, and has not been published previously. The final version of the paper has been seen and approved by the authors that are sure of the integrity of the work. No conflict of interest and financial interest exists. The present study was performed without any grants, contracts or other forms of financial support. The authors disclose any relationship with industry and financial associations that might pose a conflict of interest in connection with the submitted article. Furthermore, we declare that our registry proposed in this manuscript complies with the Declaration of Helsinki, that the locally appointed ethics committee has approved the research protocol and that informed consent has been obtained from all the recruited subjects. In this manuscript, we underline the common anamnestic and echocardiographic flaws and deficiencies commonly found in the clinical reports of patients with asymptomatic aortic stenosis and briefly describe the design and method of the “IDEAS registry”, a clinical/echocardiographic attempt to improve the diagnostic evaluation and to refine the prognostic stratification of patients with asymptomatic aortic stenosis. We think that our work, thought as a “perspective article” contains original arguments that may be object of discussion and may be of interest for the broad audience of your journal, which is primarily interested in discussing and solving problems that physicians encounter in their daily clinical practice. We hope you will agree. Sincerely, Giovanni Cioffi The corresponding author: Giovanni Cioffi MD, Echocardiography Laboratory, Villa Bianca Hospital, via Piave 78, 38100 Trento, Italy. Tel: +39 (0) 461 916000; Fax: +39 (0) 461 916874 E.mail: [email protected]

Manuscript (All Manuscript Text Pages in MS Word format, including Title Page, References and Figure Legends)

Implementation of Diagnosis in asymptomatic patiEnts with Aortic Stenosis: the IDEAS registry

Giovanni Cioffi, MD 1 Andrea Rossi, MD 2 Stefano Nistri, MD 3 Pompilio Faggiano,MD 4

From:

Department of Cardiology, Villa Bianca Hospital Trento Department of Cardiology, University of Verona CMSR Veneto Medica Altavilla Vicentina

1

2

3

Cardiology Unit, Spedali Civili Brescia 4

Corresponding author: Giovanni Cioffi, MD. Villa Bianca Hospital; Via Piave 78; 38100 Trento Telephone: +39-461916000 Fax: +39-461916874 E.mail:[email protected]

1

Abstract Not infrequently in clinical practice, some physicians refer patients with aortic stenosis (AS) for an invasive approach in the asymptomatic phase of the disease. This empirical behavior, which is in contrast with the recommendations of the current international clinical guidelines, is due to the perception that the prognosis of these patients is truly worse than retained. Actually, the management of asymptomatic patients with AS remains controversial, and there is not a clear agreement on how to reduce excess mortality and morbidity demonstrated in these patients by recent randomized clinical trials. The prevailing attention of the attending physicians is often limited to the assessment of the AS severity and appearance of symptoms, but it has been clearly shown, instead, that the impaired prognosis of these patients, is mainly due to excessive left ventricular (LV) mass growth and increased atherosclerosis leading to coronary artery disease, heart failure, stroke and death. Thus, beside the markers of faster AS progression, many other clinical and echocardiographic variables should be considered, collected and used together with the clinical/echocardiographic prognostic scores recently validated by several authors in clinical practice, where the vast majority of these variables are guiltily not taken into any consideration. The IDEAS registry (registry on the Implementation of Diagnosis in asymptomatic patiEnts with Aortic Stenosis) is a prospective study designed with the aim to improve the diagnostic evaluation and improve the prognostic stratification of patients with asymptomatic AS.

Key words: aortic stenosis, aortic valve replacement, echocardiography, aortic valve calcification, diagnostic assessment.

2

Degenerative aortic valve stenosis (AS) is the most frequent type of valvular disease in the Western world requiring surgery. In the elderly population the prevalence is 2-3 percent and considerably increases with age (1,2). Cardiologists have defined recommendations by practical guidelines for AS patients: there is a consensus that intervention has to be considered in the presence of symptoms, while it may be postponed in asymptomatic patients (1,2). In clinical practice, patients with mild-moderate or asymptomatic severe AS are managed according to the clinical experience and subjective feelings of the attending physicians, lacking of stringent diagnostic and therapeutic suggestions by guidelines or protocols proposed by the available literature. Thus, it occurs that some patients are managed by a conservative approach that is often justified by a high risk of surgery which shifts the balance of risk/benefit ratio towards waiting for symptom development. This attitude might also be favoured by the lack of information about reliable selection criteria of high-risk subgroups that would particular benefit from early surgery, in other cases might arise by inaccuracy in the diagnostic process or by the underestimation of the prognostic importance of comorbidities and cardiovascular risk factors, but also it might be generated by the lack of prospective studies assessing specific therapeutic strategies. On the other side, not infrequently in clinical practice, some physicians refer patients for an invasive approach in the asymptomatic phase of the disease. This empirical behavior could be induced by the perception that the prognosis of these patients is truly worse than retained (2-4). The truth of the matter is that, as of today, the management of asymptomatic patients with AS remains controversial, and there is not a clear agreement on how to reduce excess mortality and morbidity (1-7). The issue is clinically relevant: degenerative aortic valve disease evolves slowly from aortic sclerosis to AS (8) and aortic sclerosis and AS have been found in approximately 29% and 2.9% of adults older than 65 years, respectively (7). The results of several studies proved suspicions that even mild aortic disease may increase mortality (5). People with mild or moderate AS and aortic sclerosis (i.e. absence of pathological 3

transvalvular pressure gradients) have an increased death rate compared with an age-matched healthy population (7,9,10). As a consequence, two main questions arise that would merit precise answers: a) why do these patients die and b) how can physicians reduce mortality rates in these patients? There is some scenery that has been recognized for the entire AS spectrum that could influence mortality and morbidity in these patients and might be convened in two large arenas: a) inaccuracy in the diagnostic process and lack of prognostic risk stratification of patients with asymptomatic AS; b) underestimation of the prognostic importance of comorbidities and cardiovascular (CV) risk factors. A first matter attains to the AS progression: there is a wide individual variability in AS progression, depending on: a) echocardiographic parameters considered, including increased baseline jet velocity (6,9,11), increased baseline peak or mean gradient (6,12), high rate of increase in jet velocity over time (6,13), moderate-to severe aortic valve calcification on echo (9), left ventricular (LV) hypertrophy (14) or inappropriately high LV mass (15), left atrial systolic performance (16), exercise-induced mean gradient increase >20 mmHg (14), bicuspid aortic valve (17), b) clinical parameters, such as coronary artery disease (9,18), older age (11,13,14,16), diabetes (14,19), metabolic syndrome (12), increased body mass index (20), functional status (6), history of smoking (20,21), systolic blood pressure (21) c) biological parameters: increased baseline BNP (22), increased C-reactive protein levels (>0.15 mg/dL) (23). It would particularly useful to assess and monitor these parameters during the follow-up for having information on the possible evolution of aortic disease beyond the baseline feature and hemodynamic characteristics.

4

A second critical point consists in the correct estimation of the degree of AS. Aortic valve area is classically measured by continuity equation method and normalized for body surface area. However, a significant overestimation of transvalvular gradients and, consequently, of the degree of AS may systematically occur in patients who have a size of the ascending aorta in the lower normal range or smaller (the “pressure recovery phenomenon”). Significant pressure recovery, indeed, takes place in this condition and can cause large discrepancies between Doppler and catheter gradients. In these patients the phenomenon of pressure recovery deserves consideration and should be assessed by measurements of the net pressure drop across the stenosis from the continuous-wave Doppler velocity of the stenotic jet, the aortic valve area as obtained with the continuity equation and the cross-sectional area of the ascending aorta. (24). Similar considerations have to be made for other indexes of aortic valve severity, alternative to the continuity equation method, such as the energy loss index (25,26), the stroke work loss (27) and the valvulo-arterial impedance, alias Zva (28-30). All these indexes provide an accurate classification of patients with AS according to the risk of CV events and would be awfully useful to further improve the accuracy and reliability of the conventional assessment of AS by Doppler ultrasound. Another pertinent theme is the amount of calcium on the stenotic valve: multislice computed tomography provides an accurate quantification of calcium fixed on the valve and predicts the severity of valve disease and short-term clinical outcome in patients with asymptomatic AS (31-33). However, additional prognostic information may be also obtained by a simpler, feasible and reproducible echocardiographic semi-quantitative score (9,34) that allows an accurate risk stratification for long-term CV adverse events both in patients with mild-moderate and in those with severe AS (9,15,34). This diagnostic methodology lead to classify patients in 4 groups according to the following criteria: 0= no calcification; 1= mildly calcified (isolated, small spots); 2= moderately calcified (multiple bigger spots); 3= heavily calcified (extensive thickening/calcification of all

5

cusps) (9,15,34). All these findings make mandatory information on the degree of aortic calcification in patients with AS at any stage of severity. Great attention should be also given to the systolic LV function. It is well known that LV ejection fraction may remain normal during chronic pressure overload despite reduced myocardial contractility by use of the preload reserve or by changes in LV geometry, and despite impairment of LV circumferential or longitudinal fibers (35-42). In essential hypertension, LV midwall shortening, reflecting function of circumferential myocardial fibers and not merely endocardial displacement, has been suggested as a more sensitive marker of LV systolic function (43) and has proven prognostic value (44). Furthermore, stress-corrected LV midwall shortening has recently been shown to be independently associated with the presence of symptoms in symptomatic AS (45). Similar to what has been reported

in hypertension and diabetes mellitus, also in patients with AS, whose left ventricles typically tend to remodel toward concentric geometry, myocardial shortening at endocardium occurs at a much greater extent than at midwall due to the cross-fiber shortening phenomenon (46). This compensatory

mechanism,

which

is

directly

related

to

the

degree

of

concentric

remodeling/hypertrophy, allows keeping near to the normal values those parameters reflecting LV endocardial displacement in spite of reduced intrinsic myocardial function. This behaviour also implies that “normal LV ejection fraction” cannot be equated with “normal LV systolic function” in patients with AS, and that the simple measurement of LV ejection fraction for assessing LV function might be largely insufficient. Strictly related to the coexistence of intrinsic myocardial dysfunction, severity of AS and preserved LV ejection fraction is the low-flow/low gradient condition, which should be searched and, if detected, described in the echocardiographic reports for its clinical and prognostic importance (35,47). The clinical relevance of this condition has been demonstrated only recently (48).

Remarkably, patients with low flow/low gradient despite severely reduced AVA are

6

characterized by similar outcome compared with patients with high gradient irrespective of the clinical presentation and the co-morbidity burden (49) and the treatment strategy (48). Furthermore,

Thus, more accurate risk stratification in these patients should certainly be taken into account, considering that the development of symptoms represents a strong predictor of operative mortality and an urgent surgical procedure has a worse outcome than an elective one. The prevailing attention of the attending physicians is often limited to the assessment of the AS severity and appearance of symptoms, but it has been clearly shown that the impaired prognosis of these patients is mostly due to excessive left ventricular mass growth and increased atherosclerosis leading to coronary artery disease, heart failure, stroke and death. Thus, beside the aortic valve area and markers of faster AS progression, many other clinical and echocardiographic variables (guiltily not routinely measured) such as the degree of valve calcification, the arterial compliance, the pressure recovery phenomenon, the LV systolic function (measured as LV longitudinal and/or midwall shortening in place of LV ejection fraction), the low-flow/low gradient condition, the myocardial response to exercise or pharmacological stress should be considered, collected and used together with the clinical/echocardiographic prognostic scores recently validated by several authors in clinical practice (22,50,51) that may facilitate the early selection, among patients with asymptomatic AS, of those having the worst outcome and who would benefit from elective treatment. The IDEAS registry, a prospective study on the Implementation of Diagnosis in asymptomatic patiEnts with Aortic Stenosis, has been designed with the aim to consider and collect a comprehensive setting of variables in asymptomatic patients with AS providing independent and additional prognostic information to that derived from conventional measures of AS severity. In clinical practice, the vast majority of these variables are not taken into any consideration. This 7

approach has no positive effect on the factors associated with increased CV adverse events in these patients and consequently, on their morbidity and mortality rate. Participant Cardiologists will be provided with a simple form in which detailed information on clinical CV risk factors, laboratory, echocardiographic features and current medical therapy will be reported. The IDEAS registry will start enrolling patients in April 2013, will last for 1 year and will include asymptomatic patients (NYHA functional class I without history of angina or syncope) with any degree of AS, evaluated as aortic valve thickening accompanied by a peak trans-aortic gradient > 25 mmHg or jet velocity > 2.5 meters per second (2). The forms gathered in the first 6 months of the study from April to September 2013) (original forms) will be compared with those (implemented forms) gathered in the last 6 months (October 2013 – March 2014). We will try to demonstrate the hypothesis that the implemented forms will contain more information than the original ones. With reference to the famous citation of Pibarot and Dumesnil (52), the final target of this registry would realistically be to “look globally and think globally” in front of a patients with AS.

8

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