Aortic stenosis: clinical guidelines

List of Abbreviations

VKA – vitamin K antagonists

AH – arterial hypertension

BP – blood pressure

AV – aortic valve

ALT – alanine aminotransferase

Anticoagulants – B01A: Antithrombotic agents

AS – aortic stenosis

AST – aspartate aminotransferase

BB – beta-blockers

ARB – angiotensin receptor blocker (angiotensin II receptor antagonists)

AA – ascending aorta

BAV – bicuspid aortic valve

DAPT – dual antiplatelet therapy

Antiplatelet agent – B01AC Platelet aggregation inhibitors excluding heparin

PCWP – pulmonary capillary wedge pressure

CHD – coronary heart disease

ACEi – angiotensin-converting enzyme inhibitors

IE – infective endocarditis

CAG – coronary angiography

BAV – balloon aortic valvuloplasty

LVEDD – left ventricular end-diastolic dimension

ESD – end-systolic dimension

CT – computed tomography

CTA of the aorta – computed tomography angiography of the aorta (coronary optical coherence tomography)

Cardiac CT – cardiac computed tomography

LV – left ventricle

LA – left atrium

Mechanical prosthesis – mechanical bileaflet aortic valve prosthesis ***

Bioprosthesis – biological prosthesis – cardiac aortic valve bioprosthesis ***

MV – mitral valve

INR – international normalized ratio

MRI – magnetic resonance imaging

Multidisciplinary team: cardiologist, cardiovascular surgeon, and any other subspecialist depending on comorbid conditions

CVA – cerebrovascular accident

AVR – aortic valve replacement (mechanical bileaflet aortic valve prosthesis***)

AVR with a biological prosthesis – cardiac aortic valve bioprosthesis***

DOACs – direct oral anticoagulants, B01A: Antithrombotic agents

CRP – C-reactive protein

Statins – C10AA HMG-CoA reductase inhibitors

TG – triglycerides

TAVI – transcatheter aortic valve implantation (transcatheter aortic valve replacement)

US – ultrasound examination

EF – ejection fraction

AV – aortic valve annulus

AF – atrial fibrillation

LDL-C – low-density lipoprotein cholesterol

PCI – percutaneous coronary intervention

TEE – transesophageal echocardiography

ECG – electrocardiography

EchoCG – echocardiography (transthoracic)

CHA2DS2-VASc – risk score for stroke and thromboembolic complications in patients with atrial flutter and fibrillation (Appendix G4).

NYHA – New York Heart Association

SVi – stroke volume index

** – the drug is included in the list of vital and essential drugs

*** – medical device implanted when providing medical care under the state guarantee program for free medical care to citizens

# – off-label drug prescription (use for indications not approved by state regulatory authorities and not mentioned in the instructions for use)

Terms and Definitions

ESC – European Society of Cardiology. These clinical guidelines additionally indicate the classes of recommendations and levels of evidence in accordance with the ESC guidelines.

Aortic stenosis (AS) – a valvular heart disease caused by narrowing of the aortic orifice, in most cases due to restricted mobility and deformation of the aortic valve cusps.

Outcome – any possible result arising from exposure to a causal factor, prophylactic or therapeutic intervention, all established changes in health status occurring as a consequence of the intervention.

Valvular heart disease – impaired cardiac function caused by morphological and/ch or functional changes in one or more heart valves. Valve changes may present as stenosis, regurgitation, or a combination thereof.

Conflict of interest – a situation in which a medical or pharmaceutical worker, while exercising their professional activities, has a personal interest—whether acting directly or through a company representative—in obtaining material gain or another advantage that influences or may influence the proper performance of their professional duties due to a contradiction between the personal interest of the medical or pharmaceutical worker and the interests of the patient.

Clinical trial – any investigation conducted in human subjects to discover or verify the clinical and/or pharmacological effects of investigational products, and/or to identify any adverse reactions to investigational products, and/or to study absorption, distribution, metabolism, and excretion with the object of ascertaining their safety and/or efficacy. The terms "clinical trial" and "clinical study" are synonymous.

Laboratory diagnostics – a set of methods aimed at analyzing test material using various specialized equipment.

Medicinal products – pharmacological substances in the form of dosage forms used for the prevention, diagnosis, and treatment of diseases, rehabilitation, and for the preservation, prevention, or termination of pregnancy.

Medical intervention – types of medical examinations and/or procedures performed by a medical worker or other personnel authorized to engage in medical activities regarding a patient, which affect the physical or mental state of a person and have a preventive, diagnostic, therapeutic, rehabilitative, or research focus, as well as artificial termination of pregnancy.

Medical worker – an individual who has a medical or other education, works in a medical organization, and whose job (official) duties include the provision of medical care, or an individual who is an individual entrepreneur directly engaged in medical activities.

Patient – an individual who receives medical care or who applies for medical care regardless of the presence of a disease and their condition.

First medical contact – the time of initial examination of the patient by a physician, paramedic, nurse, or ambulance crew members who record an electrocardiogram (ECG) (and have the results of its interpretation) and can perform initial interventions (e.g., cardiac defibrillation). First medical contact may occur either at the prehospital stage or upon initial hospitalization of the patient.

Valve replacement – replacement of a native valve with a prosthesis that performs its function.

Working Group for the Development/Updating of Clinical Guidelines – a team of specialists working together and in coordination to develop/update clinical guidelines and bearing joint responsibility for the results of this work.

Valve repair – the restoration of valve function without its replacement.

Symptom (from Greek *symptoma* – sign, occurrence) – a manifestation of a disease, a statistically significant deviation of a parameter from its normal limits, or the emergence of a qualitatively new phenomenon uncharacteristic of a healthy organism.

Syndrome – a stable set of several symptoms with a single pathogenesis.

Condition is an alteration of the organism arising from the impact of pathogenic and/or physiological factors that requires medical care.

Thesis-recommendation – a statement reflecting the procedure and correctness of performing a particular medical intervention with proven efficacy and safety.

Level of evidence reliability – the degree of confidence that the observed effect of a medical intervention is true.

Level of убедительности рекомендаций (Class of Recommendation, CoR) – the degree of certainty in the reliability of the intervention effect and that adherence to recommendations will bring more benefit than harm in a specific clinical situation.

Surgical treatment is a method of treating diseases by dividing and uniting tissues during a surgical operation.

Percutaneous balloon valvuloplasty – restoration of valve function using interventional endovascular methods.

1. Brief information on the disease or condition

1.1 Definition of the disease or condition

Aortic stenosis (AS) – narrowing of the aortic orifice that impedes normal blood flow from the left ventricle (LV) to the aorta, resulting in an increased pressure gradient between the left ventricle and the aorta. The most common cause is aortic valve stenosis. Rarer causes include subvalvular and supravalvular aortic stenosis.

Hemodynamic criteria for AS are:

• acceleration of blood flow across the AV of more than 2.0 m/s,

• reduction of the AV opening area to less than 3 cm².

1.2 Etiology and pathogenesis of the disease or condition (group of diseases or conditions)

The most common cause of AS in adults is calcification of the cusps of a normal tricuspid valve or a congenital bicuspid valve [1-3]. Calcification spreads from the base of the cusps to their free edge, causing restricted cusp mobility and a reduced aortic orifice area without commissural fusion. Calcific AS is an active pathological process characterized by inflammation and calcification; the contribution of genetic factors to the development of the disease is also discussed [3-7, 135-138]. Rheumatic AS is caused by commissural fusion followed by destruction and ultimately calcification of the cusp edges; it is currently much less common and is typically accompanied by mitral valve involvement. Congenital AV disease can also lead to stenosis and is a more frequent cause at a young age [8, 139]. Infective endocarditis is another cause of AS and often runs an asymptomatic or masked course [9].

In adults, obstruction in AS develops gradually, usually over decades. During this period, the LV adapts to pressure overload through hypertrophy, which leads to an increase in LV wall thickness while LV cavity volume remains normal [5-7].

AS is characterized by a prolonged period of compensation for LV pumping function. As a result of increased wall thickness and reduced myocardial compliance, an increase in LV end-diastolic pressure is not accompanied by ventricular dilation. In late stages of the disease, systolic dysfunction of the hypertrophied myocardium develops, accompanied by a decrease in LV ejection fraction and, accordingly, transvalvular pressure gradients. The development of concentric LV myocardial hypertrophy is an adaptive response to high intraventricular pressure; however, the hypertrophied heart exhibits a relative decrease in coronary blood flow and a limitation of coronary vasodilator reserve even in the absence of coronary artery disease [1-3, 6].

1.3 Epidemiology of the Disease or Condition

According to many international experts, comprehensive data on the prevalence of valvular heart diseases do not exist, making a global epidemiological study necessary. In the Euro Heart Survey, which included 5,001 adult patients with valvular heart disease, mitral regurgitation and calcific aortic stenosis were the most frequently registered conditions [1].

Precise epidemiological data on the prevalence of AS in the Russian Federation are currently lacking. Four epidemiological studies on the prevalence of AS have been conducted in Europe and the USA. Based on 11,911 echocardiographic examinations, AS was diagnosed in 0.4% of patients. The prevalence of AS increases with age: while it is 0.2% under 65 years, it reaches 1.3% in patients aged 65 to 74 years, and 2.8% in those over 75 years [10].

Given the lack of a strategy aimed at preventing AS or slowing its progression, the prevalence of AS is not expected to decrease in the near future. Moreover, due to the widespread aging of the population, a significant increase in the number of patients with AS is projected over the coming decades. According to demographic statistics on prevalence derived from a US population study, the number of individuals aged 75 years or older with at least moderate AS will double over the next 50 years [10].

1.4 Features of Coding the Disease or Condition

I35.0 Aortic (valve) stenosis

I35.2 Aortic (valve) stenosis with insufficiency

I35.8 Other aortic valve disorders

I35.9 Aortic valve disorder, unspecified

Q23.0 Congenital stenosis of aortic valve

I06.0 Rheumatic aortic stenosis

I06.2 Rheumatic aortic stenosis with insufficiency

I06.8 Other rheumatic aortic valve diseases

I06.9 Rheumatic aortic valve disease, unspecified

I08.2 Combined diseases of aortic and tricuspid valves

I08.8 Other multiple valve diseases

I08.9 Multiple valve disease, unspecified

Diagnosis formatting examples:

• Primary: Congenital heart disease: Bicuspid aortic valve. Severe aortic stenosis.

  Complications: Heart failure with preserved EF (68%), Stage 1, II-III NYHA class.

1.5 Classification of the disease or condition

Table PB-1 (Appendix B) presents the severity of AS based on hemodynamic and physical examination data [2, 11].

In severe stenosis with normal cardiac output, the mean transvalvular pressure gradient is usually greater than 40 mmHg. However, patients with severe AS and reduced cardiac output may exhibit lower transvalvular gradients and peak velocities.

Based on aortic valve gradient and cardiac output parameters, it is appropriate to distinguish the following phenotypes of severe AS: normal left ventricular ejection fraction (LVEF) and high gradient (normal flow-high gradient); reduced LVEF and high gradient (low flow-high gradient); low LVEF, reduced stroke volume, and low systolic gradient (classical low flow-low gradient); normal or mildly reduced LVEF, reduced stroke volume, and low systolic gradient (paradoxical low flow-low gradient) [170].

Some patients with severe AS may be asymptomatic, whereas those with moderate AS may be symptomatic. Patient management strategies for AS, primarily indications for surgical correction, are largely based on the presence or absence of symptoms. Even with moderate stenosis (maximum blood flow velocity not exceeding 3.0 m/s), the average rate of stenosis progression is as follows: an increase in maximum blood flow velocity of 0.3 m/s annually; an increase in mean pressure gradient of 7 mmHg annually; a decrease in aortic valve area of 0.1 cm² annually [5, 12-14].

1.6 Clinical presentation of the disease or condition

For a long time, AS is asymptomatic and is often diagnosed incidentally during transthoracic echocardiography (TTE). All clinical symptoms identified during patient history taking and physical examination are non-pathognomonic, which often hinders early diagnosis. Characteristic symptoms of progressive AS are angina pectoris and syncope. Dyspnea on exertion and at rest, as well as cardiac arrhythmias (ventricular extrasystoles, atrial fibrillation), are frequently observed [3, 6]. Physical examination of patients with AS may reveal pale skin due to a tendency toward peripheral vasoconstrictor reactions; in late stages, acrocyanosis may be present. Peripheral edema is detected in severe AS. Percussion reveals a shift of the left and lower borders of the heart; palpation reveals displacement of the apex beat and a systolic thrill in the suprasternal notch. Auscultatory signs of AS include a harsh systolic murmur over the aorta and mitral valve, with muffling of the first and second heart sounds over the aorta. In decompensated heart failure, moist rales and/or crepitus are auscultated in the lungs of patients, lower extremity edema appears, orthopnea may be observed (the patient assumes a forced position—sitting or lying in bed with the head of the bed elevated), and hepatosplenomegaly is verified on palpation.

2. Diagnostics, medical indications and contraindications for diagnostic methods

Criteria for establishing the diagnosis/condition:

The diagnosis of aortic stenosis is established based on a combination of complaints, medical history, and findings from diagnostic imaging methods (echocardiography). Once the diagnosis is established, indications for surgical treatment are determined.

2.1 Complaints and Anamnesis

At the diagnostic stage, an analysis of complaints and medical history is conducted for all patients suspected of having AS. During medical history taking in a patient suspected of having AS, previous instances of seeking medical care and the results of such visits are clarified, along with the availability of instrumental study results and reports to assess various parameters dynamically; known comorbidities of the patient are clarified to assess additional risks; all currently taken medications are clarified for therapy adjustment, as well as any drugs previously discontinued due to intolerance or inefficacy to reduce the risk of allergic and anaphylactic reactions and to ensure optimal therapy selection.

ESC/RSC I B (LOC C, LOE 5)

• At the diagnostic stage, it is recommended that a cardiologist and/or a general practitioner (family physician) take the medical history and inquire about complaints (regarding cardiac and pericardial pathology) in all patients with suspected AS to verify the diagnosis and determine further management strategies [2, 3, 11].

ESC/RSC I B (LOC C, LOE 5)

Comments: the history of AS in adults includes a long latent period during which morbidity and mortality are very low. The progression of AS may be faster in patients with degenerative atherosclerosis (calcification) than in those with congenital AS or rheumatic heart disease. Therefore, regular clinical follow-up is mandatory for all patients with mild to moderate asymptomatic AS.

• When interviewing a patient with known or suspected AS, it is recommended to pay attention to the presence of angina pectoris, exertional dyspnea, and syncope in order to rule out or confirm symptomatic AS [2, 3, 6, 7, 11].

ESC/RSC IA (LOC C, LOE 5)

Comments: after the onset of these symptoms, the risk of sudden death increases, and life expectancy is two to three years [2, 13].

Sudden death is known to occur in patients with severe AS. Prospective echocardiographic studies have revealed that sudden death in asymptomatic patients is rare: occurring in less than 1% of patients with diagnosed AS per year [12, 15, 16].

2.2 Physical Examination

For diagnostic purposes, a physical examination is performed in all patients with suspected AS, as well as to identify comorbidities. During the physical examination, all patients with AS or suspected AS undergo: a general examination, inspection of the skin of the face, torso, and limbs, inspection and palpation of the precordium, percussion and auscultation of the heart and lungs, palpation of the radial pulses and dorsalis pedis arteries, blood pressure measurement by Korotkoff's method in the supine, sitting, and standing positions, calculation of heart rate and pulse rate, inspection of the neck veins, palpation of the anterior lower leg to determine signs of venous congestion, determination of pulse deficit, auscultation of projection points of the carotid arteries, abdominal aorta, and iliac arteries, and palpation of the abdomen, parasternal points, and intercostal spaces to detect various signs of both the primary and comorbid conditions.

ESC/RSC I B (LOC C, LOE 5)

Comments: AS can usually be suspected based on the detection of a harsh crescendo-decrescendo systolic ejection murmur upon auscultation. Examination findings are specific but not sensitive for the diagnosis of "severe AS". Classical signs of severe AS include a loud (grade IV–VI) late systolic murmur radiating to the carotid arteries, splitting (including paradoxical splitting) of the second heart sound, and a slow-rising, low-volume carotid pulse. The murmur is best heard at the upper right or left sternal border. Normal physiological splitting of the second heart sound is a reliable criterion for ruling out severe AS. However, in elderly patients, the carotid pulse may be normal due to reduced vascular compliance, and the systolic murmur may be soft and radiate toward the apex [6, 7].

2.3 Laboratory Diagnostics

ESC/ACC IIa C (LoE C, LoR 5)

Comments: testing for hepatitis B surface antigen (HbsAg), hepatitis C virus antibodies, Treponema pallidum antibodies, and human immunodeficiency virus (HIV) 1/2 IgM and IgG antibodies as part of preoperative preparation may be performed within primary health care.

ESC/ACC I C (LoE C, LoR 5)

ESC/ACC IIa C (LoE C, LoR 5)

ESC/ACC IIa C (LoE C, LoR 5)

2.4 Instrumental Diagnostics

2.4.1 Non-invasive diagnostic methods

ESC/RSC I B (LOC C, LOE 5)

Comments: the absence of ventricular hypertrophy, atrial dilation, arrhythmias, conduction disturbances, prior myocardial infarction, and signs of acute ischemia on the ECG provides valuable information. If pathological ECG changes such as ventricular hypertrophy or prior myocardial infarction are detected in a patient with a heart murmur, a more thorough workup including echocardiography should be performed.

• Echocardiography is recommended in all patients with a harsh systolic murmur, an unsplit second heart sound, or symptoms suggestive of AS to verify the diagnosis [2, 4-6, 11, 18, 142, 176].

ESC\ACC I A (GoR C, LoE 5)

• Echocardiography is recommended in all patients with suspected or previously diagnosed AS to diagnose and assess the severity of AS, as well as preoperatively and/or postoperatively in cases of surgical treatment [2, 4, 5, 11, 14, 18, 142, 176].

ESC\ACC I A (GoR C, LoE 5)

• Echocardiography is recommended in all patients with suspected or previously diagnosed AS to assess left ventricular wall thickness, volume, and function, and to rule out infective endocarditis and thrombosis [2, 4, 5, 11, 14, 18, 142, 176-178].

ESC\ACC I A (GoR C, LoE 5)

ESC/ACC IIb B (LoE C, LoR 4)

Comments: in patients with severe AS during dobutamine infusion**, stroke volume and gradient increase while the aortic valve area remains unchanged. An increase in aortic valve area (>1.0 cm²) and an increase in flow velocity after low-dose dobutamine infusion** indicate pseudo-severe AS. If dobutamine infusion** fails to increase stroke volume (by less than 20% from baseline), it indicates low myocardial "contractile reserve" and a poor prognosis with both medical therapy and surgical intervention. Dobutamine stress testing** in patients with AS should only be performed in centers experienced in pharmacological stress testing and in the presence of a cardiologist.

ESC/ACC IIa C (LoE C, GoR 5)

ESC/ACC III A (LoE C, LoR 5)

ESC/ACC IIa C (LoE C, GoR 5)

ESC/RSC I B (LOC C, LOE 5)

Comments: targeted chest radiography provides qualitative information on cardiac chamber sizes, pulmonary blood flow, pulmonary and systemic venous pressure, and cardiac calcification. Pathological findings on chest radiography are an indication for echocardiography.

ESC/ACC I B (LoE B, LoR 2)

• Exercise stress testing is not recommended in symptomatic patients with AS [2, 11, 14, 18, 21, 22].

ESC/ACC III A (LoE B, LoR 2)

Comments: exercise testing in asymptomatic patients should only be performed under the supervision of an experienced physician with continuous blood pressure and ECG monitoring. The test has low diagnostic accuracy for detecting concomitant coronary artery disease. This is due to baseline ECG abnormalities, left ventricular hypertrophy, and reduced coronary reserve.

ESC/ACC IIa C (LoE C, GoR 5)

ESC/ACC IIa C (LoE C, GoR 5)

Comments: Cardiac CT is widely used in the topical diagnosis of ascending aortic aneurysms. It also plays an important role in preparing patients for transcatheter aortic valve implantation (TAVI).

• Contrast-enhanced ECG-synchronized cardiac CT (spiral ECG-synchronized computed tomography of the heart) as well as coronary CT angiography is recommended for all patients being considered as candidates for TAVI [2, 4, 11, 14, 18, 21, 24, 25].

ESC/RSC I C (LoE C, GoR 5)

ESC/RSC IIa B (LoE B, GoR 2)

Comments: the following aortic valve calcium score thresholds in Agatston units are proposed: >3000 (men), >1600 (women) - high probability of severe AS; >2000 (men), >1200 (women) - moderate probability; <1600 (men), <800 (women) - low probability.

ESC/ACC IIa C (LoE C, GoR 5)

2.4.2 Invasive diagnostic methods

ESC IIa C (COR C, LOE 5)

• Performing CAG or evaluating a prior one (performed no more than 6 months ago) is recommended for all patients with AS to detect hemodynamically significant coronary artery stenosis prior to open surgical, transcatheter, or hybrid intervention in the following situations: age over 40 years, history and/or symptoms of CAD, signs of myocardial ischemia, LVEF <50%, one or more CAD risk factors, or post-radiation injury, to rule out concomitant hemodynamically significant coronary stenosis prior to valvular surgery [11, 18].

ESC I C (LoE C, LoR 5)

ESC/RSC IIb B (LoE C, GoR 5)

ESC IIa B (LoE B, LoR 2)

2.5 Other Procedures

Other diagnostic examinations for AS are not specified; diagnostic workups may be expanded at the physician's discretion depending on the clinical situation and the patient's condition.

3. Treatment, including drug and non-drug therapies, diet therapy, and pain management

3.1 Risk stratification when planning surgical treatment for a patient with aortic stenosis

To select surgical tactics and optimize treatment, identifying risk factors and predicting surgical outcomes is a paramount task. For this purpose, formulas for assessing mortality risk presented on the websites of the Society of Thoracic Surgeons (STS) [147] and the European System for Cardiac Operative Risk Evaluation (European System for Cardiac Operative Risk Evaluation – EuroSCORE) [148] are used. Logistic EuroSCORE ≥ 10%, EuroSCORE II ≥ 4%, or an operative risk level ≥ 10% according to the STS scale are proposed as high-risk criteria [149, 150]. The choice of additional diagnostic methods to verify concomitant diseases is determined by the clinical situation. When planning patient treatment, it is important to consider a number of factors not included in the EuroSCORE and STS scales that affect the risk of complications from AV interventions. Frailty is a reduction in physiological reserve and the ability to maintain homeostasis, which increases stress sensitivity and, accordingly, the risk of complications during surgical and transcatheter interventions. Frailty assessment is based on a number of objective criteria, and corresponding scales have been developed for this task [151-153]. Malnutrition, cachexia, and cognitive impairment are associated with a high risk of complications and poor prognosis after surgical or transcatheter AV interventions [154, 155]. Individual anatomical features affecting the surgical correction technique: " porcelain" aorta, severe calcification of the AV annulus and adjacent structures of the LV outflow tract [156, 157]. Pathology of other organs and systems — kidney, liver, and lung diseases. Preoperative liver failure is associated with an increased risk of complications. Chronic kidney disease stage 4 and 5 present in the patient (glomerular filtration rate <30 mL/min) causes a high risk of acute renal failure in the early postoperative period, the need for dialysis, severe complications, and an unfavorable outcome. Lung pathology combined with pain syndrome in the early postoperative period after AV intervention using full median sternotomy in the case of prolonged mechanical ventilation is a risk factor for respiratory system complications [159-161]. Since the prevalence and severity of comorbidities increase with patient age, accurate assessment of the risk-benefit ratio of a particular treatment method becomes more complex. When planning patient treatment, it is necessary to take into account the capabilities, experience, and outcomes of the specific clinic where the patient will be treated. A multidisciplinary team of specialists should play the primary role in solving these tasks.

3.2 Conservative treatment

Prevention of rheumatic fever exacerbation

ESC / RSC I A (LoE C, GoR 1)

Comments: prophylactic administration of penicillin antibiotics (J01C Beta-lactam antibacterials, penicillins) is indicated for 10 years after the last rheumatic fever flare-up or until the age of 40. Patients who have had a single rheumatic attack are at high risk for recurrent rheumatic flares. Patients suffering with rheumatic carditis have an increased tendency for recurrent rheumatic attacks, making secondary prevention of great clinical importance to prevent disease progression, heart failure decompensation, and thromboembolic events in major vessels. Continuous antibacterial prophylaxis, combined with the identification of a laboratory-confirmed etiologic agent of rheumatic fever, has proven effective. Lifelong prophylaxis is indicated for patients with high-risk AS (Group A streptococcus carriers).

Prevention of infective endocarditis

ESC/RSC I B (LoE C, GoR 5)

Treatment of arterial hypertension and lipid-lowering therapy

ESC/RSC IIa B (LoE C, GoR 5)

Comments: ACE inhibitors/ARBs can be used to treat hypertension. Diuretics and beta-blockers should be prescribed with caution, especially in patients with severe asymptomatic AS [28-30].

• The use of statins is not recommended to slow the progression of AS [11, 14, 18, 27, 31, 176].

ESC/RSC III A (LoE A, GoR 2)

• The use of statins is recommended for all patients with AS for the primary and secondary prevention of cardiovascular events, based on standard risk scoring scales in accordance with current clinical guidelines on "Lipid Metabolism Disorders" [11, 14, 18, 27, 31, 145].

ESC/RSC I A (LoE C, GoR 5)

Comment: patients with symptomatic valvular disease require surgical intervention rather than medical therapy. At the same time, careful assessment and management of atherosclerosis risk factors are important in patients with aortic valve disease to prevent concomitant CAD.

Treatment of heart failure

• Medical therapy for chronic heart failure (CHF) is recommended for all patients with severe AS in accordance with current clinical guidelines on "Chronic Heart Failure" [14, 17, 18, 146, 176].

ESC/RSC I A (LE Level C, SOR 5)

Comments: AS therapy must include standard CHF medical therapy—diuretics, angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers, beta-blockers, potassium-sparing diuretics (C03D Aldosterone antagonists and other potassium-sparing agents), angiotensin II receptor blockers in combination with other agents, and sodium-glucose cotransporter 2 (SGLT2) inhibitors (gliflozins)—which improves both symptoms and patient prognosis [14, 17, 18].

ACE inhibitors/valsartan + sacubitril**, beta-blockers (BBs), aldosterone antagonists, and dapagliflozin**/empagliflozin** (sodium-glucose cotransporter 2 inhibitors) are indicated as part of a combined four-drug regimen for the treatment of all patients with symptomatic CHF with reduced ejection fraction (≤40%) to reduce CHF-related hospitalization and death. In patients with CHF with mildly reduced ejection fraction, ACE inhibitors/ARBs, BBs approved for CHF with reduced ejection fraction, and aldosterone antagonists may be indicated to reduce the risk of CHF hospitalization and death. For ACE inhibitors and ARBs, there is limited evidence of their ability to reduce symptom severity and improve functional class in CHF with preserved ejection fraction. BBs may be prescribed to patients with CHF with preserved ejection fraction if additional indications are present.

Doses of drugs affecting preload and afterload should be titrated slowly with careful blood pressure monitoring, as excessive preload reduction can lower cardiac output and systemic blood pressure, especially in patients with severe AS due to the small cavity of the hypertrophied left ventricle. It should be borne in mind that the use of vasodilators (C01D Vasodilators used in cardiac diseases) in such patients carries a risk of hypotension. In syncope, if not caused by brady- or tachyarrhythmia, there is no specific therapy. In all cases where diuretics are prescribed, close monitoring of blood electrolytes and renal function is indicated.

Following successful surgical treatment of AS with persistent CHF, standard CHF therapy is not contraindicated.

Anticoagulant therapy

• Lifelong administration of vitamin K antagonists (VKAs) under INR monitoring is recommended for all patients with an implanted mechanical prosthesis to prevent thromboembolic complications [11, 14, 18, 36-38, 176, 188, 189].

ESC I B (LOC A, LOE 1)

• Self-monitoring of INR is recommended for all patients on VKA therapy, provided they have undergone prior appropriate training in a patient education school and are under medical supervision (remote laboratory monitoring or regular physician visits) [18, 37, 38, 176, 187].

ESC/RSC I B (LOC A, LOE 1)

ESC/RSC I B (LOC C, LOE 5)

• Direct oral anticoagulants (DOACs) and/or dual antiplatelet therapy (DAPT) are not recommended in patients with established mechanical heart valve prostheses [11, 18, 176].

ESC/RSC III B (LOC C, LOE 5)

• The addition of low-dose acetylsalicylic acid** (75–100 mg/day) to VKAs is recommended following thromboembolic complications that occurred despite proper INR control [11, 18, 43, 44, 176].

ESC/ACC IIa C (LoE C, LoR 5)

ESC/RSC IIa C (LoE C, GoR 5)

ESC/ESC IIb C (Level of Evidence C, Grade of Recommendation 5)

• In high bleeding risk patients with implanted coronary stents and a mechanical aortic valve prosthesis, it is recommended to consider a duration of triple therapy consisting of acetylsalicylic acid** (75–100 mg/day), clopidogrel** (75 mg/day), and a VKA for 1 week, regardless of the type of stent used and the clinical presentation (acute coronary syndrome or stable coronary artery disease) [14, 45, 46].

ESC/ESC IIa B (Level of Evidence A, Grade of Recommendation 3)

Comments: after discontinuation of acetylsalicylic acid** (75–100 mg/day), continue dual therapy preferably including clopidogrel** (75 mg/day) and a VKA, with discontinuation of the antiplatelet agent and transition to monotherapy at 6 months after elective PCI and at 12 months after ACS.

• In patients with a mechanical aortic valve prosthesis and implanted coronary stents who are at high ischemic risk (acute coronary syndrome or presence of anatomical/procedural features) exceeding the bleeding risk, it is recommended to consider prescribing triple therapy including acetylsalicylic acid** (75–100 mg/day), clopidogrel** (75 mg/day), and a VKA for up to 30 days [14, 45, 46].

ESC/ESC IIa B (Level of Evidence A, Grade of Recommendation 3)

Comments: the addition of low doses (75–100 mg/day) of acetylsalicylic acid to VKA therapy may reduce the incidence of thromboembolic complications at the cost of an increased bleeding risk. Therefore, the addition of antiplatelet agents (B01AC Antiplatelet agents excluding heparin) to VKAs should be restricted to patients at very high risk of thromboembolic complications, where the benefits substantially outweigh the risks [46]. In patients with thromboembolic complications despite target INR levels, low doses (75–100 mg/day) of acetylsalicylic acid** should be added to VKAs.

• In patients with a mechanical aortic valve prosthesis requiring acetylsalicylic acid** and/or clopidogrel** in addition to VKAs, it is recommended to carefully maintain the VKA dosage in the lower part of the target therapeutic INR range, and time in therapeutic range should be >65–70% [14].

ESC/RSC IIa B (LOC C, LOE 5)

• In patients with no indication for anticoagulant therapy, the administration of low-dose acetylsalicylic acid** (75–100 mg/day) or anticoagulant therapy with VKAs is recommended for the first 3 months following aortic valve replacement with a bioprosthesis [11, 18, 176].

ESC/RSC IIa B (LOC C, LOE 5)

ESC/RSC I C (LOC C, LOE 5)

• Long-term anticoagulant therapy is recommended for patients after bioprosthesis implantation who have other indications for anticoagulant therapy (atrial fibrillation (AF) with a CHA2DS-VASc score (Appendix G4) of ≥3 in women and ≥2 in men, venous thrombosis, hypercoagulability, or, with a lower level of evidence, marked left ventricular dysfunction with an LVEF <35%) [18, 39-42, 176].

ESC/RSC I B (LOC B, LOE 2)

• DOACs are recommended as preferred over VKAs starting 3 months after TAVI with a bioprosthesis in patients with AF [18, 176].

ESC/ACC IIa C (LoE C, LoR 5)

• Single antiplatelet therapy with low-dose acetylsalicylic acid** (75–100 mg/day) is recommended for the first 3 months after valve-sparing aortic valve procedures in the absence of other indications for anticoagulant therapy [18, 176].

ESC/ACC IIa C (LoE C, LoR 5)

• Lifelong anticoagulant therapy is recommended in patients after transcatheter aortic valve implantation (TAVI) if other indications for anticoagulant therapy are present (AF, venous thrombosis, hypercoagulability, or, with a lower level of evidence, marked left ventricular dysfunction with an LVEF <35%) [11, 18].

ESC/RSC I B (LOC C, LOE 5)

• Lifelong single antiplatelet therapy with low-dose acetylsalicylic acid** (75–100 mg/day) is recommended after TAVI in patients without indications for anticoagulant therapy [11, 18, 176].

ESC/RSC I A (LOC C, LOE 5)

• DAPT is not recommended in patients after TAVI for thrombosis prevention in the absence of clear indications [176, 197].

ESC/RSC IIa C (LOC B, LOE 2)

• Routine use of anticoagulant therapy is not recommended after TAVI in patients with no indications for anticoagulant therapy [11, 18, 176].

ESC/RSC III B (LOC C, LOE 5)

• To prevent stroke in patients with AF and aortic stenosis, direct oral anticoagulants are recommended in preference to VKAs as anticoagulant therapy [18, 32-35, 176].

ESC/RSC I A (LOC B, LOE 2)

Comments: in patients with severe aortic stenosis who will have an indication for surgical treatment with a mechanical heart valve prosthesis in the near future, VKAs are preferred.

3.3 Surgical Treatment

Indications for aortic valve replacement in symptomatic patients

• Intervention (surgical aortic valve replacement under cardiopulmonary bypass) is recommended for patients with symptomatic, severe, high-gradient aortic stenosis (mean gradient >40 mm Hg, aortic jet velocity >4 m/s, and aortic valve area <1 cm² or indexed AVA <0.6 cm²/m²) [2, 4, 11, 14, 18, 48-50, 176].

ESC/RSC I B (LOC B, LOE 2)

• Intervention (surgical aortic valve replacement under cardiopulmonary bypass) is recommended for symptomatic patients with severe low-flow (SVi <35 mL/m²), low-gradient (<40 mm Hg) aortic stenosis with reduced left ventricular ejection fraction (<50%) and evidence of myocardial contractile reserve [14, 18, 51].

ESC/RSC I B (LOC C, LOE 4)

• Intervention (surgical aortic valve replacement under cardiopulmonary bypass) is recommended in symptomatic patients with low-flow, low-gradient aortic stenosis (<40 mm Hg) and preserved left ventricular ejection fraction only after confirmation of severe aortic stenosis [2, 11, 13, 14, 18, 20, 176].

ESC/RSC IIa C (LOC C, LOE 4)

• Intervention (surgical aortic valve replacement under cardiopulmonary bypass) is recommended for symptomatic patients with low-flow, low-gradient aortic stenosis and reduced left ventricular ejection fraction in the absence of myocardial contractile reserve, provided severe aortic stenosis is confirmed by CT (calcium scoring) [18, 25, 51, 176].

ESC/RSC IIa C (LOC C, LOE 4)

Comments: in these cases, transfemoral TAVI should be considered given its lower perioperative mortality compared to conventional aortic valve replacement.

• Intervention (surgical aortic valve replacement under cardiopulmonary bypass) is not recommended in patients with severe comorbidities when the anticipated intervention is unlikely to improve quality of life or increase life expectancy by more than 1 year [18, 52-60, 176].

ESC/RSC III C (LOC C, LOE 4)

Indications for aortic valve replacement in asymptomatic patients

• Intervention (surgical aortic valve replacement under cardiopulmonary bypass) is recommended for asymptomatic patients with severe AS and left ventricular systolic dysfunction (LV EF <50%) in the absence of other causes [2, 4, 11, 14, 18, 20, 48-50, 61-64, 176].

ESC/RSC I B (LOC B, LOE 2)

• Intervention (surgical aortic valve replacement under cardiopulmonary bypass) is recommended for asymptomatic patients with severe AS who develop symptoms during exercise testing [2, 4, 11, 14, 18, 48-50, 176].

ESC/ACC I C (Level of Evidence C, Quality of Evidence 4)

• Intervention (surgical aortic valve replacement under cardiopulmonary bypass) should be considered for asymptomatic patients with severe AS and left ventricular systolic dysfunction (LV EF <55%) in the absence of other causes of reduced EF [2, 4, 14, 18, 20, 49, 50, 61-64, 176].

ESC/ACC IIa B (Level of Evidence C, Quality of Evidence 4)

• Intervention (surgical aortic valve replacement under cardiopulmonary bypass) is recommended for asymptomatic patients with severe AS and an abnormal exercise test showing a drop in blood pressure of >20 mm Hg during testing [2, 4, 12, 14, 18, 48-50].

ESC/RSC IIa C (LOC C, LOE 4)

• Intervention (surgical aortic valve replacement under cardiopulmonary bypass) is recommended for asymptomatic patients with an LV EF >55% and normal exercise test results, provided the surgical risk is low and one of the following parameters is present:

  - critical AS (mean gradient >60 mm Hg or aortic peak velocity >5 m/s);

  - severe aortic valve calcification (confirmed by CT) or an increase in peak aortic velocity of >0.3 m/s per year;

  - significantly elevated B-type natriuretic peptide (BNP) level (>3-fold increase), confirmed by repeated measurements and without other explanations [11, 13-15, 18, 65-69, 176].

ESC/ACC IIa B (Level of Evidence C, Quality of Evidence 4)

Comments: in adult patients with severe, symptomatic, calcified AS, surgical aortic valve replacement is the only effective treatment. Young patients with congenital or rheumatic AS may be candidates for valvotomy. The treatment strategy for patients with severe AS is presented in Appendix B.

ESC/ACC IIa B (Level of Evidence C, Quality of Evidence 5)

Recommendations on the choice of artificial heart valve type

• Surgical aortic valve replacement with a mechanical prosthesis is recommended in the presence of the patient's written informed consent and in the absence of contraindications to long-term anticoagulant therapy (increased bleeding risk due to comorbidities, poor compliance, as well as geographical, domestic, and occupational conditions) [18, 70-72, 176].

ESC/ACC I C (LoE C, LoD 5)

• Surgical aortic valve replacement with a mechanical prosthesis is recommended for patients already receiving anticoagulant therapy due to the presence of a mechanical heart valve in another position [18].

ESC/ACC IIa C (Level of Evidence C, Quality of Evidence 5)

• Surgical aortic valve replacement with a mechanical prosthesis is recommended for patients with an optimal life expectancy in the absence of contraindications to long-term anticoagulant therapy [176, 179-181].

ESC/ACC IIa B (Level of Evidence B, Quality of Evidence 2)

• For patients younger than 65 years, it is recommended to discuss SAVR with a mechanical prosthesis [18, 73, 74, 176].

ESC/ACC IIa B (Level of Evidence C, Quality of Evidence 5)

• Surgical aortic valve replacement with a mechanical prosthesis is recommended for patients at risk of rapid structural degeneration of a bioprosthesis (hyperparathyroidism, hemodialysis) [18].

ESC/RSC I C (LoE C, GoR 5)

• Surgical aortic valve replacement with a mechanical prosthesis is recommended for patients with an optimal life expectancy (considering age, gender, comorbidities, and national life expectancy) in whom reoperation on the valve (if feasible) would be associated with a high risk of complications (low EF, deep vein thrombosis, pulmonary embolism, hypercoagulability, antiphospholipid syndrome, etc.) [18].

ESC/ACC IIa C (LoE C, LoR 5)

Comments: the choice of the implanted prosthesis type (mechanical or biological) is the result of balancing the risk of bleeding/embolism associated with a mechanical prosthesis against the risk of degenerative changes in biological prostheses. A mechanical prosthesis is preferred for patients under 65 years of age in the absence of additional bleeding risk factors. In patients with AS aged 65 years and older, both types of prostheses are acceptable, taking into account the risk of bleeding, social status (living in rural areas, difficulties with INR monitoring), expected patient compliance with anticoagulant therapy, presence of comorbidities (severe heart failure, atrial fibrillation) requiring anticoagulants, as well as patient preferences [11, 14, 73-75].

• Surgical aortic valve replacement with a bioprosthesis is recommended in the presence of the patient's written informed consent or in the presence of contraindications to long-term anticoagulant therapy (high risk of hemorrhagic complications, comorbidities, non-compliance, poor availability of therapy, personal preferences, lifestyle, and occupation), as well as in patients with a life expectancy shorter than the expected durability of the bioprosthesis [18, 70-72, 176].

ESC/ACC I C (LoE C, LoD 5)

• Surgical aortic valve replacement with a bioprosthesis is recommended when effective anticoagulation is unlikely (low compliance, limited availability) or contraindicated due to a high bleeding risk (prior major bleeding, comorbidities, poor compliance, patient reluctance, lifestyle, occupation), in patients whose life expectancy is shorter than the expected durability of the bioprosthesis (life expectancy of >10 years is estimated based on age, gender, comorbidities, and national life expectancy) [11, 18, 176].

ESC/ACC I C (LoE C, LoD 5)

• Surgical aortic valve replacement with a bioprosthesis should be discussed for reoperation due to mechanical prosthesis thrombosis despite adequate long-term anticoagulant therapy [18].

ESC/ACC I C (LoE C, LoD 5)

• Surgical aortic valve replacement with a bioprosthesis should be discussed for patients with a low probability and/or low surgical risk when performing reintervention on the valve [18].

ESC/ACC IIa C (Level of Evidence C, Quality of Evidence 5)

• Surgical aortic valve replacement with a bioprosthesis should be discussed in young women planning pregnancy [11, 18].

ESC/ACC IIa C (Level of Evidence C, Quality of Evidence 5)

ESC/ACC IIb B (Level of Evidence C, Quality of Evidence 4)

• Surgical aortic valve replacement is recommended in younger patients with low surgical risk (under 75 years or STS-PROM/EuroSCORE II <4%) or in patients unsuitable for transfemoral TAVI [18].

ESC/RSC I B (LOC C, LOE 5)

Indications for catheter balloon aortic valvuloplasty (BAV)

ESC/ACC IIb C (Level of Evidence C, Quality of Evidence 4)

ESC/ACC IIb C (Level of Evidence C, Quality of Evidence 4)

ESC/RSC IIb C (LoE C, GoR 4)

Comments: BAV plays an important role in the management of adolescents and young adults, but has limited application in adults [14]. Immediate hemodynamic results include a moderate decrease in the transvalvular pressure gradient, but the valve area after valvotomy rarely exceeds 1.0 cm². Early symptomatic improvement usually occurs despite small changes in valve area. However, major acute complications occur in >10% of cases [83], and the majority of patients experience restenosis and clinical deterioration within 6–12 months post-procedure. Indications for palliative valvotomy in patients for whom surgical aortic valve replacement is not preferred due to severe comorbidities are not well established, and there are no data showing improved survival.

Indications for transcatheter aortic valve implantation (TAVI)

• The choice between open cardiac surgery and transcatheter intervention is recommended to be based on a careful assessment of clinical, anatomical, and surgical factors by a multidisciplinary team, taking into account the risks and benefits of each option individually for a specific patient [11, 18, 49, 84-96, 176].

ESC/RSC I C (Level of Evidence B, Quality of Evidence 1)

• TAVI is recommended in elderly patients (over 75 years of age) or those patients who have a high surgical risk (STS-PROM/EuroSCORE II > 8%) or are unsuited for open cardiac surgery [18, 48, 84-87, 97, 176].

ESC/RSC I A (Level of Evidence B, Quality of Evidence 2)

• Open cardiac surgery or TAVI are recommended for the remaining categories of patients not specified above, based on individual clinical, anatomical, and surgical characteristics [18, 48, 84-97].

ESC I B (LOC B, LOR 1)

ESC/RSC IIb C (LoE C, GoR 5)

• TAVI is recommended for patients with severe AS and a predicted life expectancy of more than 1 year (taking into account comorbidities) in whom, according to the multidisciplinary team's assessment, surgical aortic valve replacement is contraindicated and an improvement in quality of life can be expected [11, 18].

ESC/RSC I C (Level of Evidence C, Quality of Evidence 5)

• TAVI is recommended for high-risk patients with severe symptomatic AS who have no absolute contraindications to SAVR, but in whom TAVI is considered the method of choice taking into account their individual risk profile [4, 11, 14, 84-87, 99].

ESC/RSC IIa B (Level of Evidence B, Quality of Evidence 2)

ESC/RSC IIa B (Level of Evidence C, Quality of Evidence 5)

• Valve-in-valve TAVI within a previously implanted bioprosthesis is recommended to be considered by a multidisciplinary team in inoperable patients or patients at high surgical risk, taking into account anatomical factors, the characteristics of the previously implanted bioprosthesis, and the assessment of the risk of coronary obstruction [4, 6, 11, 14].

ESC/RSC I B (Level of Evidence C, Quality of Evidence 5)

Comments: the procedure is indicated for patients with severe AS in whom, according to the conclusion of a multidisciplinary team of specialists, open-heart surgery is contraindicated due to concomitant pathology. An operative risk score of ≥ 8% according to the STS or EuroSCORE II scales has been proposed as a selection criterion for TAVI. At the same time, when choosing treatment tactics, the multidisciplinary team should take into account not only the STS and EuroSCORE II criteria, but also such surgical risk factors as calcification of the ascending aorta, patient frailty, radiation therapy, and a history of coronary artery bypass grafting, which are not accounted for in scoring systems [100].

• When performing valve-in-valve TAVI within a previously implanted bioprosthesis, it is recommended to use a transcatheter bioprosthetic valve with the maximum effective orifice area to prevent patient-prosthesis mismatch [4, 6, 9, 11, 14].

ESC/ACC I C (LOE C, GOR 5)

• TAVI is not recommended in case of mismatch between the aortic annulus dimensions and the type of prosthesis used, presence of a left ventricular thrombus, active infective endocarditis, high risk of coronary artery obstruction (short distance between the annular plane and coronary ostia), severe atheromatosis of the ascending aorta with mobile thrombi, high risk of embolism, tortuous anatomy, or severe stenosis of the femoral, iliac arteries, or abdominal aorta (for transfemoral access) [14, 176].

ESC/RSC III C (Level of Evidence C, Quality of Evidence 5)

Comments: Relative contraindications include:

- Bicuspid aortic valve or moderate valve calcification;

- Coronary artery disease requiring revascularization;

- Hemodynamic instability;

- Left ventricular ejection fraction <20%;

- Severe pulmonary disease, inability to access the cardiac apex (for transapical access);

- Left atrial appendage thrombosis.

• TAVI is not recommended in the presence of comorbidities that compromise the expected benefit of AS correction [101].

ESC/RSC III C (Level of Evidence B, Quality of Evidence 2)

ESC/RSC IIb B (Level of Evidence C, Quality of Evidence 5)

ESC/RSC IIa C (Level of Evidence C, Quality of Evidence 5)

Comments: the staging of percutaneous coronary intervention (PCI) and TAVI is determined by the multidisciplinary team based on individual clinical and anatomical features. In the presence of absolute indications for coronary revascularization in patients with critical AS and hemodynamic instability, simultaneous PCI and TAVI should be considered.

In selected high-surgical-risk patients who are not candidates for surgery under cardiopulmonary bypass, with pronounced asymmetric hypertrophy of the basal interventricular septum and a high probability of dynamic left ventricular outflow tract obstruction after TAVI, a staged intervention involving alcohol septal ablation in an expert center may be considered (in the absence of contraindications and with suitable coronary anatomy) [171, 172].

ESC/RSC IIb C (Level of Evidence C, Quality of Evidence 5)

3.4 Other treatment

Analgesic therapy in adults

Perioperative pain management is routine; the analgesic strategy is determined by the attending physician and the anesthesiologist-resuscitator depending on the scope of the surgical intervention.

• All patients with AS admitted to the hospital for surgical treatment are recommended to receive anxiolytics in the evening before surgery as part of premedication for sedation and emotional stability to reduce emotional stress. Opioids and/or benzodiazepine derivatives are used for premedication before transferring the patient to the operating room to provide sedation and emotional stability [102].

ESC/ACC I C (LOE C, GoE 5)

Comments: in the evening before surgery: benzodiazepine derivatives in individual dosages. Before transfer to the operating room: intramuscular trimeperidine** and/or diazepam**/midazolam**. Drugs that increase heart rate should be excluded from premedication.

• All patients with AS admitted to the hospital for surgical treatment are recommended to receive the following for intraoperative anesthesia: propofol**, benzodiazepine derivatives, halogenated hydrocarbons. Fentanyl** (for premedication before surgery), diazepam** (as part of preoperative preparation) [102, 103, 166].

ESC/RSC I C (Level of Evidence A, Quality of Evidence 2)

Comments: the following drugs are used for intraoperative anesthesia: midazolam**/diazepam**/propofol** and fentanyl**, sodium oxybutyrate**; halogenated hydrocarbons can be used in combination with intravenous fentanyl** in calculated dosages. A multicenter randomized controlled trial revealed no differences in clinical outcomes between total intravenous anesthesia based on propofol** and fentanyl** versus combined anesthesia using halogenated gaseous anesthetics (N01AB Halogenated hydrocarbons) and fentanyl** during cardiac surgeries [167].

• All patients with AS admitted to the hospital for surgical treatment are recommended to receive age-appropriate dosages of opioids for analgesia in the early postoperative period [102].

ESC/ACC I C (LOE C, GoE 5)

Comments: drugs used for postoperative analgesia: first day after surgery — trimeperidine** or morphine** intramuscularly every 4–8 hours, NSAIDs (M01A Non-steroidal anti-inflammatory and antirheumatic products). If special infusion pumps are available, patient-controlled analgesia with fentanyl** is effective. If severe pain persists, trimeperidine**/morphine**/fentanyl** as indicated.

Use of nitric oxide in the postoperative period

• For patients with aortic stenosis undergoing surgical treatment who have pre-capillary pulmonary hypertension (mean pulmonary arterial pressure ≥ 20 mm Hg, pulmonary artery wedge pressure ≤ 15 mm Hg), a pulmonary vascular resistance of more than 5 Wood units, and echocardiographic signs of RV dysfunction in the intra- and postoperative period, it is recommended to consider the use of inhaled nitric oxide [104].

ESC/ACC IIa B (CBR B, LOR 1)

Comments: patients with pathological changes of the aortic valve are sometimes characterized by an increase in pulmonary circulation pressure (group 2 pulmonary hypertension, post-capillary pulmonary hypertension). Over time, such patients begin to develop an increased pulmonary vascular resistance, i.e., a pre-capillary component appears (reactive pulmonary hypertension). Surgical intervention on the aortic valve effectively relieves the post-capillary component of pulmonary hypertension. However, the elevated pulmonary resistance (pre-capillary component) persists in the postoperative period, adversely affecting hemodynamic parameters up to the development of RV dysfunction. A published meta-analysis confirmed a significant improvement in clinical parameters—a reduction in mechanical ventilation duration and length of stay in the intensive care unit with inhaled nitric oxide [104].

4. Medical Rehabilitation and Sanatorium-Resort Treatment

Medical (cardiac) rehabilitation is presented as a three-stage system within which patient routing is implemented (Appendix B, Figure PB-1) [105]. Medical rehabilitation care for patients with aortic stenosis is provided on a scheduled basis after diagnosis establishment (upon initial patient contact) or in chronic disease courses regardless of disease duration, provided the patient's clinical state is stable, medical indications are present, and contraindications to specific rehabilitation methods are accounted for.

When planning surgical correction for aortic stenosis, patient preparation for effective recovery is indicated to begin in the preoperative period to inform the patient about the nature and scope of the surgical intervention, train them in the optimal perception of their well-being after surgery, and teach them how to properly follow postoperative recommendations. Rehabilitation measures and methods should be applied taking into account the rehabilitation stage and the patient's clinical and physical status.

ESC / ACC IIa C (CBR B, LOR 2)

Comments: the presence of contraindications to exercise training is not a factor limiting patient participation in cardiac rehabilitation programs and does not preclude the use of other physical rehabilitation methods (therapeutic exercise complexes, walking, etc.).

ESC / ACC IIa C (CBR C, LOR 5)

Comments: most cardiac rehabilitation programs are carried out at the outpatient stage, which is indicated to be conducted in-person, remotely (at home using digital and mobile health tools), or in a blended format to increase patient reach for rehabilitation measures, and to improve adherence to lifestyle modification, rehabilitation, and drug therapy [112-115].

ESC / ACC IIa C (CBR C, LOR 5)

ESC/ESC IIa C (LoE C, GoR 5)

Comments: to assess the patient's clinical status, level of functioning and daily activity, and the impact of personal and environmental factors, it is indicated to use standardized and valid diagnostic methods, assessment tools based on the International Classification of Functioning, Disability and Health (ICF) available for this purpose (www.icf-research-branch.org/download/category/12-cardiovascularandrespiratoryconditions) [105, 117-119]. ICF is a tool for describing organ and system dysfunctions and limitations in daily functions (self-care, communication, performance of professional and social roles) resulting from a disease/injury in a patient, taking into account the influence of environmental factors that may facilitate or hinder the patient's performance of the described functions.

ESC / ACC IIa C (CBR C, LOR 5)

Comments: if indicated, it is recommended to perform testing using the Hospital Anxiety and Depression Scale (HADS) to identify symptoms of anxiety/depression (Appendix G, Table PG-2).

ESC/ACC IIa C (CBR C, LOR 5)

Comments: patient information and education should be conducted in any available format (individually, within rehabilitation counseling, and/or in the "School for Patients with Valvular Heart Disease") in person or online [107, 115, 120].

ESC/ ACC IIb C (CBR C, LOR 5)

Comments: in patients with AS aged ≥60 years who have undergone TAVI or open AVR, it is recommended to additionally perform screening for frailty using the “Timed Up and Go” test with time recording (Timed “Up and go” test») (Appendix G, figure AG-4) to individualize the rehabilitation program and determine indications for a comprehensive geriatric assessment [107, 108, 121-125].

ESC/ACC IIa C (CBR C, LOR 4)

Comments: a personalized physical training program in patients after surgical treatment of aortic stenosis (in the absence of contraindications, Appendix A3-2) is formed depending on the cardiac rehabilitation stage and includes regular moderate-intensity aerobic (dynamic) physical exercises (low-intensity at the start), low- to moderate-intensity resistance exercises (as indicated) to increase and/or maintain lower limb muscle endurance/strength in patients with low risk of postoperative complications, good wound healing after sternotomy, and no earlier than six weeks after surgery.

Both in patients with AS who have undergone surgery and in AS patients without surgical treatment, the physical rehabilitation program (in the absence of contraindications) includes therapeutic exercise complexes with breathing exercises, inspiratory muscle training using breathing trainers (as indicated) and other breathing techniques (as indicated), and walking. For the safety of the physical rehabilitation program, it is indicated to monitor the patient's condition (complaints, clinical symptoms, blood pressure level, heart rate, and ECG - as indicated), and to assess the level of physical exertion using the Borg scale (Borg Rating of Perceived Exertion, Borg RPE) during training (Appendix G, Table PG-3) [102, 116].

5. Prevention and Dispensary Observation

Dispensary follow-up (Active surveillance)

• All patients with AS, as well as those after aortic valve replacement, are recommended lifelong follow-up by a cardiologist, or in the absence of a cardiologist, by a general practitioner or family physician to determine the frequency of visits, monitor compliance with prescribed recommendations, timely modify therapy, assess cardiovascular risk, refer for additional examinations, sanatorium-resort treatment, and, if necessary, hospitalization [126, 127, 176].

ESC/RSC I C (LoE C, GoR 5)

ESC/RSC I C (LoE C, GoR 5)

• Echocardiography is recommended for all patients with previously diagnosed AS for reassessment when clinical symptoms change [2, 4, 5, 11, 12, 18, 142, 176].

ESC\ACC I A (GoR C, LoE 5)

• Echocardiography is recommended for the dynamic follow-up of asymptomatic patients with previously diagnosed AS: every year for severe AS, every 1–2 years for moderate AS, and every 3–5 years for mild AS [2, 4, 5, 11, 12, 14, 18, 142].

ESC\ACC I A (GoR C, LoE 5)

Comments: performing echocardiography as a 1st-line non-invasive diagnostic test is necessary in all patients with suspected AS, symptoms of AS, or an auscultatory murmur, serving as the "gold standard" for diagnosis. Echocardiography is considered the most valuable non-invasive diagnostic method for AS, as it not only verifies AS but also in most cases identifies the cause of AS, assesses its severity, evaluates left ventricular function and dimensions, the dimensions of other heart chambers, and determines prognosis and the timing of surgical valve intervention.

Comprehensive assessment of AS includes:

– measurement of transvalvular flow;

– determination of the mean transvalvular pressure gradient;

– calculation of the effective valve area.

Attention to detail in accurately measuring pressure and flow is crucial, especially in patients with low cardiac output or low transvalvular pressure gradients.

ESC \ RSC I C (Level of Evidence C, Quality of Evidence 5)

Comments: The examination includes:

- Transthoracic echocardiography;

- Electrocardiography (12 leads);

- Targeted chest X-ray in 2 projections (anteroposterior and left lateral);

- Complete (clinical) blood count with differential;

- General clinical biochemical blood test;

- Determination of the international normalized ratio (INR) (in case of VKA therapy).

• Following the initial postoperative examination, it is recommended to monitor and re-examine the AS patient (with echocardiography) at 6 and 12 months, and then annually in case of an uncomplicated clinical course [11, 14, 18, 106, 142].

ESC \ RSC I C (Level of Evidence C, Quality of Evidence 5)

• In the absence of changes in the clinical status of a patient with diagnosed AS, it is recommended to undergo an examination once a year. If there is a change in clinical status (suspicion of infective endocarditis, new cardiac murmurs on auscultation, worsening heart failure symptoms), performing echocardiography is recommended [14, 106, 142].

ESC \ RSC I C (Level of Evidence C, Quality of Evidence 5)

ESC \ RSC I C (Level of Evidence C, Quality of Evidence 5)

ESC/ACC I C (LoE C, LoR 5)

ESC/ACC IIa C (LoE C, LoR 5)

ESC/ACC IIa C (LoE C, LoR 5)

• Patients with AS and after AVR are recommended to undergo resting ECG registration, analysis, description, and interpretation of electrocardiographic data once a year during a follow-up visit and additionally upon the appearance of arrhythmia, as well as when prescribing or modifying treatment that affects intracardiac electrical conduction [126, 127].

ESC \ RSC I C (Level of Evidence C, Quality of Evidence 5)

ESC \ RSC I C (Level of Evidence C, Quality of Evidence 5)

• To resolve the question of referring patients with AS for echocardiography, transesophageal echocardiography, MRI, CT, coronary angiography, and other imaging studies, it is recommended to conduct a follow-up outpatient appointment (examination, consultation) with a cardiologist [126, 127].

ESC/RSC I C (LoE C, GoR 5)

Prevention

ESC \ RSC I A (Level of Evidence C, Quality of Evidence 5)

Comments: prophylactic administration of penicillin-series antibiotics (J01C Beta-lactam antibacterials, penicillins) is indicated for 10 years after the last rheumatic fever attack or until the age of 40. Patients who have had a single rheumatic attack are at high risk of recurrent rheumatic exacerbations. Those suffering from rheumatic heart disease have an increased tendency to recurrent rheumatic attacks; therefore, their secondary prophylaxis is of great clinical significance in preventing the progression of the valve defect, decompensation of chronic heart failure, and thromboembolic events in major vessels. Continuous antibacterial prophylaxis, combined with the identification of a laboratory-confirmed etiological agent of rheumatism, has proven to be effective. Lifelong prophylaxis is indicated for patients with high-risk AS (Group A streptococcus carrier state)

• All patients with an implanted mechanical prosthesis are recommended lifelong VKA therapy monitored by INR for the prevention of thromboembolic complications [11, 14, 18, 37, 38, 61].

ESC \ RSC I B (Level of Evidence A, Quality of Evidence 1)

ESC \ RSC I B (Level of Evidence A, Quality of Evidence 1)

• All patients on VKA therapy are recommended to perform INR self-monitoring, provided they have undergone prior appropriate training in a patient school and medical oversight is maintained (remote monitoring of the laboratory parameter or regular physician visits) [18, 37, 38, 176, 187].

ESC/RSC I B (LOC A, LOE 1)

ESC/RSC I B (Level of Evidence C, Quality of Evidence 5)

Comments: history of thromboembolism, atrial fibrillation, hypercoagulability, venous thrombosis, severe left ventricular dysfunction (left ventricular ejection fraction less than 35%).

• Patients taking VKAs are recommended to discontinue the drug at least 4 days prior to elective non-cardiac surgery associated with a high risk of postoperative complications and death, aiming for an INR <1.5, and to resume VKA therapy within 24 hours after surgery in the absence of contraindications [176, 190-192].

ESC/RCS I B (Level of Evidence B, Grade of Recommendation 1)

ESC/RCS IIa B (Level of Evidence B, Grade of Recommendation 1)

ESC/RCS I A (Level of Evidence A, Grade of Recommendation 1)

ESC/RCS IIb B (Level of Evidence B, Grade of Recommendation 3)

• For the prevention of infective endocarditis, antibacterial therapy is recommended prior to dental procedures in all patients with mechanical and biological prostheses in accordance with current clinical guidelines on "Infective Endocarditis and Cardiac Implantable Electronic Device Infections" [11, 143].

ESC/RCS IIa C (LoE C, GoR 5)

ESC/RCS IIa C (LoE C, GoR 5)

• In patients after aortic valve replacement and with left ventricular dysfunction, heart failure pharmacotherapy is recommended in accordance with current clinical guidelines for "Chronic Heart Failure" [17, 126, 127, 146].

ESC/RCS I B (Level of Evidence C, Grade of Recommendation 5)

ESC/RCS IIa C (Level of Evidence C, Grade of Recommendation 5)

6. Organization of Medical Care

Indications for planned hospitalization:

1) Clinical manifestations of the disease;

2) Elective surgery for aortic valve replacement or reconstruction;

3) Manifestations of heart failure.

Indications for emergency hospitalization:

1) New-onset atrial fibrillation;

2) Pulmonary edema;

3) Hemodynamic instability.

Indications for patient discharge from the hospital:

1) Stable hemodynamics;

2) Completion of surgical treatment;

3) Satisfactory laboratory and instrumental test results.

7. Additional Information

To select the surgical approach and optimize treatment, a crucial task is identifying risk factors and predicting surgical outcomes. Surgical risk can be assessed fairly quickly—formulas for assessing mortality risk are available on the websites of the Society of Thoracic Surgeons (www.sts.org) and the European System for Cardiac Operative Risk Evaluation (www.euroscore.org) [14, 43-45]. A logistic EuroSCORE ≥ 20% or an operative risk level ≥ 10% according to the STS scale are proposed as criteria for high risk.

Criteria for Evaluating the Quality of Medical Care

Quality assessment criteria for primary health care in adults with aortic stenosis (ICD-10 codes: I35.0, I35.2, I35.8, I35.9, Q23.0, I06.0, I06.2, I06.8, I06.9, I08.2, I08.8, I08.9)

Quality assessment criteria for specialized medical care in adults with aortic stenosis (ICD-10 codes: I35.0, I35.2, I35.8, I35.9, Q23.0, I06.0, I06.2, I06.8, I06.9, I08.2, I08.8, I08.9)

References

Appendix A1. Working Group Composition

Working Group Chairs:

Bokeria L.A., Academician of the Russian Academy of Sciences

Kuts E.V., MD, (Moscow) SCVS

Irtyuga O.B., MD, (Saint Petersburg) RSC

Working Group Members:

Alekyan B.G., Academician of the Russian Academy of Sciences, (Moscow) Chairman of RSSSC

Amiragov R.A., PhD, (Moscow), not a member of associations

Aronov D.M., MD, Professor, (Moscow) RSC, RFS

Asatryan T.V., PhD, (Moscow) SCVS

Afanasyev A.V., PhD, (Novosibirsk) RSC

Babakekhyan M.V., (Saint Petersburg) RSC

Bogachev-Prokofyev A.V., MD, (Novosibirsk) SCVS

Boytsov S.A., Academician of the Russian Academy of Sciences, (Moscow) RSC

Bubnova M.G., MD, Professor, (Moscow) RSC, RFS

Gordeev M.L., MD, Professor, (Saint Petersburg) SCVS

Dzhordzhikiya R.K., MD, Professor, (Kazan) SCVS

Zheleznev S.I., MD, Professor, (Novosibirsk) SCVS

Imaev T.E., MD, (Moscow) RSSSC

Kalashnikov S.V., PhD, Associate Professor, (Moscow) SCVS

Kovalev S.A., MD, Professor, (Voronezh) SCVS

Kozlov B.N., MD, (Tomsk) SCVS

Komlev A.E., (Moscow) RSC

Malenkov D.A., (Moscow) SCVS

Meleshenko N.N., PhD, (Moscow)

Mironenko V.A., MD, (Moscow) SCVS

Moiseeva O.M., MD, Professor, (Saint Petersburg) RSC

Muratov R.M., MD, Professor, (Moscow) SCVS

Nikitina T.G., MD, Professor, (Moscow) SCVS

Petrosyan K.V., Prof., (Moscow) RSSSC

Pogosova N.V., MD, Professor, (Moscow) RSC

Protopopov A.V., MD, Professor, (Krasnoyarsk) RSSSC

Pugina M.Yu., (Saint Petersburg) RSC

Rosseykin E.V., MD, (Khabarovsk) SCVS

Skopin I.I., MD, Professor, (Moscow) SCVS

Sukhova I.V., PhD, (Saint Petersburg) RSC

Uspensky V.E., MD, (Saint Petersburg) RSC, SCVS

Khubulava G.G., Academician of the Russian Academy of Sciences, (Saint Petersburg) SCVS

Charchyan E.R., MD, Professor, (Moscow) SCVS

Shadrina U.M., (Saint Petersburg) RSC

Shlyakhto E.V., Academician of the Russian Academy of Sciences, (Saint Petersburg) RSC member

Shneider Yu.A., MD, (Kaliningrad), SCVS

All members of the Working Group have confirmed that they have no financial support or conflicts of interest to disclose.

Appendix A2. Methodology for Developing Clinical Guidelines

Target audience of clinical guidelines

1. Cardiologist.

2. General practitioner / Physician.

3. General practitioner (family physician).

4. Cardiovascular surgeon.

Since the RSC is a member of the European Society of Cardiology (ESC) and RSC members are also ESC members, all European guidelines are formulated with the participation of Russian experts who are co-authors of the guidelines. Thus, existing ESC guidelines reflect the consensus of leading Russian and European cardiologists.

Therefore, the development of national guidelines was based on ESC guidelines, taking into account national specifics, examination and treatment features, and the availability of certain medical care. For this reason, during the development of Russian clinical guidelines by the RSC, international recommendation classes of indications were used, which make it possible to assess the necessity of implementing the recommendation statement and the levels of evidence for these classes (Tables 1/A2 and 2/A2).

In cases where classes and levels of evidence were absent in the European guidelines, but in the opinion of the RCO experts these statements were extremely necessary for implementation or, conversely, strictly not recommended for use, the RCO experts, based on the rules for forming recommendation classes according to the European Society of Cardiology guidelines, assigned the classes and levels themselves. In this situation, the designation ESC/RCO denotes classes assigned by the RCO experts.

In addition, a new grading system for levels of evidence (LE) and grades of recommendation (GR) for therapeutic, rehabilitative, preventive, and diagnostic interventions has been added (Tables 3/A2, 4/A2, and 5/A2), introduced in 2018 by the Center for Expertise and Quality of Medical Care of the Russian Ministry of Health. Thus, the text of the clinical guidelines developed by RCO experts simultaneously uses two grading scales (Tables 1/A2, 2/A2, 3/A2, 4/A2, 5/A2). In cases where classes and levels of evidence were absent in the European guidelines, but in the opinion of the RCO experts these statements were extremely necessary for implementation or, conversely, strictly not recommended for use, the RCO experts, based on the rules for forming recommendation classes according to the European Society of Cardiology guidelines, assigned the classes and levels themselves. In this situation, the designation ESC/RCO denotes classes assigned by the RCO experts.

In addition, a new grading system for levels of evidence (LE) and grades of recommendation (GR) for therapeutic, rehabilitative, preventive, and diagnostic interventions has been added (Tables 3, 4, and 5), introduced in 2018 by the Center for Expertise and Quality of Medical Care of the Russian Ministry of Health. Thus, the clinical guidelines developed by RCO experts use two grading scales simultaneously.

Table 1/A2. Classes of recommendations according to the European Society of Cardiology (ESC) guidelines.

Table 2/A2. Levels of evidence according to the European Society of Cardiology (ESC) guidelines.

Table 3/A2. Scale for assessing levels of reliable evidence (LRE) for diagnostic methods (diagnostic interventions)

Table 4/A2. Scale for assessing levels of evidence (LE) for methods of prevention, treatment, and medical rehabilitation, including those based on natural therapeutic factors (preventive, therapeutic, and rehabilitative interventions)

Table 5/A2. Scale for assessing grades of recommendation (GR) for methods of prevention, diagnosis, treatment, and medical rehabilitation, including those based on natural therapeutic factors (preventive, diagnostic, therapeutic, and rehabilitative interventions)

Procedure for updating clinical guidelines.

The update mechanism for clinical guidelines provides for their systematic revision—at least once every three years, as well as upon the emergence of new evidence-based data regarding the diagnosis, treatment, prevention, and rehabilitation of specific diseases, or the availability of justified additions/comments to previously approved clinical guidelines, but no more frequently than once every 6 months.

Appendix A3. Reference Materials

Appendix A3-1

1. Federal Law No. 323-FZ of November 21, 2011, "On the Fundamentals of Protecting the Health of Citizens in the Russian Federation";

2. Order of the Russian Ministry of Health No. 918n dated November 15, 2012, "On Approval of the Procedure for Providing Medical Care to Patients with Cardiovascular Diseases";

3. Order of the Ministry of Labor of Russia No. 1024n dated December 17, 2015, "On Classifications and Criteria Used in Medical and Social Assessment of Citizens by Federal State Medical and Social Assessment Institutions";

4. Order of the Russian Ministry of Health No. 788n dated July 31, 2020, "On Approval of the Procedure for Organizing Medical Rehabilitation for Adults";

5. Order of the Russian Ministry of Health No. 203n dated April 14, 2025, "On Approval of Criteria for Assessing the Quality of Medical Care";

6. Order of the Russian Ministry of Health No. 103n dated February 28, 2019, "On Approval of the Procedure and Timeframes for Developing Clinical Guidelines, Their Revision, the Standard Template for Clinical Guidelines, and Requirements for Their Structure, Composition, and Scientific Validity of the Information Included in Clinical Guidelines".

Appendix A3-2. Contraindications to physical training in patients after surgical correction of aortic stenosis

• Prior intraoperative myocardial infarction (not earlier than 3 weeks from the onset of myocardial infarction);

• Postoperative complications (postpericardiotomy syndrome with pericarditis and/or pleurisy, pulmonary edema, newly emerged cardiac dysfunction, surgical wound suppuration, and septic conditions);

• Prosthesis-related complications (prosthesis dysfunction, thromboembolic complications, prosthetic valve infective endocarditis);

• Pronounced sternal diastasis (contraindication for performing a set of exercises for the upper extremities and trunk);

• Heart failure functional class IV;

• Uncontrolled arterial hypertension (BP >180/110 mm Hg);

• Angina attacks;

• Syncope; drop in systolic BP ≥20 mm Hg in response to physical exertion;

• Cardiac arrhythmias (high-grade extrasystoles or tachyarrhythmias) and conduction disturbances (grade II-III atrioventricular block);

• Thromboembolism or thrombophlebitis (within up to 3 months);

• Acute cerebrovascular accident or transient ischemic attack (within up to 3 months);

• High bleeding risk;

• Uncontrolled diabetes mellitus;

• Severe renal impairment;

• Cognitive impairment.

Appendix A3-3. Questionnaire for patients with severe aortic stenosis based on echocardiography results for referral to a cardiovascular center consultation

Table PA3-1. Classification of aortic stenosis severity [142].

Optimization of the diagnostic process

The screening and verification stage for valvular heart disease is usually carried out at the outpatient diagnostic stage. Patients with severe valvular disease, or patients with other severity levels and stages but with severe comorbidities, are referred to a multidisciplinary center with a cardiosurgical department for a cardiologist consultation. If it is necessary to determine indications for surgical treatment of the valve defect, the multidisciplinary center cardiologist refers the patient for a consultation with a cardiovascular surgeon (Table PA3-2).

Table PA3-2. Stages of diagnostic care for patients with valvular heart disease

Table PA3-3. Target INR values after aortic valve replacement with a mechanical prosthesis requiring lifelong anticoagulant therapy

Note. AV – aortic valve; LV – left ventricle; EF – ejection fraction.

Appendix B. Physician Action Algorithms

Algorithm for initial diagnosis and treatment of patients with aortic stenosis [106]

Appendix C. Patient Information

Dear Patient!

You are facing heart surgery. The more you know about your heart, the easier it will be to cope with the challenges of the postoperative period.

We invite you to familiarize yourself with the basic concepts of heart anatomy and surgical procedures, the features of the postoperative period, and we also recommend a physical rehabilitation program for the first 12 months after surgery.

A healthy person's heart is a powerful, continuously working organ that ensures blood flow throughout the body and quickly adapts to its constantly changing demands. In one minute, the heart beats 60 to 80 times; during physical exertion, the rhythm accelerates, and more blood flows through the heart than at rest. The heart consists of 4 chambers – two atria and two ventricles, on the border between which are valves that allow blood to flow in one direction. A muscular wall septum divides the heart into right and left halves. The right atrium receives blood from the upper and lower parts of the body and through the tricuspid valve enters the right ventricle, which pumps it into the lungs via the pulmonary valve. In the lungs, the blood is enriched with oxygen. Arterial blood returns to the left atrium and through the mitral valve enters the left ventricle, which, contracting, pumps blood into the arteries supplying organs and tissues. Giving off oxygen and picking up carbon dioxide, the blood becomes venous and returns through the veins to the right atrium.

The four heart valves – mitral, aortic, tricuspid, pulmonary – let blood pass in one direction and prevent its backflow. A healthy valve has thin, uniform leaflets.

Pathological changes in the valves can be either congenital or acquired as a result of rheumatic fever, infection, coronary artery disease, or aging. Stenosis – narrowing of the orifice – or valve regurgitation, when the leaflets do not close tightly, can develop. This increases the workload on the heart. Over time, a person begins to experience palpitations, chest pain, shortness of breath, weakness, fatigue, leg edema, and fainting.

There is a need for surgery to repair the valve (reconstructive or plastic surgery) or replace the damaged valve (replacement).

Currently, various models of biological and mechanical heart valves have been developed and are in use. A mechanical valve consists of a ring-shaped cuff covered with synthetic fabric and an occluding element in the shape of a disc or two pivoting discs. Biological prostheses are made from various animal tissues. They can be completely donor-derived (human, porcine), as well as prostheses constructed from animal tissues. The advantage of mechanical prostheses is their durability. The disadvantages of mechanical prostheses include the need for lifelong anticoagulant therapy and the possibility of infection.

Preparation for the upcoming surgery is of great importance. It is necessary to follow the doctor's recommendations regarding medication intake and to prepare your lungs for the surgical intervention.

Quit smoking as soon as possible! Smoking narrows the coronary arteries, increases blood clotting, promotes mucus accumulation in the bronchi, raises blood pressure, and causes palpitations. All of the above can cause complications in the postoperative period.

In the early postoperative period after transfer from the intensive care unit, your activity regimen will be determined by your attending physician. We suggest you memorize a few simple movements:

1. get out of bed by rolling onto your side;

2. get up from a chair by moving to the edge and placing your feet on the floor. Stand up by pushing off with your legs;

3. sit straight with both feet on the floor. Knees at hip level. Do not cross your legs;

4. when picking up objects from the floor, do not bend at the waist! Bend your knees, your back must be straight.

Depending on your condition, you will undergo early rehabilitation measures: a physical therapist will prescribe inhalation therapy for better expectoration, and an exercise therapy specialist will conduct a course of massage and therapeutic exercises. Physical exertion is selected strictly individually for each patient.

In the early postoperative period, the goals of therapeutic exercise are:

- prevention and treatment of early postoperative complications;

- improvement of respiratory system functions;

- adaptation of the heart to new hemodynamic conditions;

- improvement of the psycho-emotional state of the patient.

Upon discharge from the hospital, you will receive recommendations from your attending physician regarding medication intake, activity level, and diet. Your recovery depends on how precisely you follow them.

Anticoagulant therapy

If you have had a mechanical prosthesis implanted, your attending physician will prescribe medications such as anticoagulants (usually VKAs) to prevent blood clots from forming on the prosthetic leaflets or heart chambers. Inadequate anticoagulant therapy (insufficient or excessive anticoagulant dose) can lead to serious complications: prosthetic valve thrombosis, stroke, bleeding. Anticoagulants are prescribed for life!

Biological prostheses do not require lifelong anticoagulants and are generally prescribed for the first 3-6 months after surgery.

Anticoagulants prolong the time it takes for your blood to clot. The effect of anticoagulants must be carefully monitored using a blood test called prothrombin time (Quick's time) and the International Normalized Ratio (INR). The anticoagulant dose is selected individually to keep prothrombin time or INR within specific parameters.

Usually, the INR needs to be maintained at 2.5-3.5.

The medication is usually taken once a day at the same time if it is a VKA. It is important to take it strictly as prescribed by your doctor.

The doctor will also tell you how often you need to monitor your INR.

Anticoagulant treatment limits the body's natural ability to stop bleeding. For this reason, you should be especially careful with activities that may lead to cuts or hemorrhages.

Anticoagulants can have teratogenic effects on the fetus; therefore, women planning a pregnancy must discuss changes to their anticoagulant therapy with their attending physician.

Before any medical procedure, inform your doctor that you are taking anticoagulants. Blood clotting monitoring is mandatory on the eve of the procedure. When performing "minor" outpatient surgical procedures (dental treatment, ingrown toenail removal, etc.), there is no need to stop the anticoagulant if the INR is within 2.0-3.0.

For major interventions (e.g., inguinal hernia repair, cholecystectomy), discontinuation of the anticoagulant may be required. In this case, in the hospital 3-5 days before surgery, the anticoagulant is stopped, and the patient is switched to unfractionated heparin or low-molecular-weight heparins (nadroparin calcium, dalteparin sodium, etc.). Anticoagulant therapy is resumed on days 2-3 after surgery.

Effect of medications and food products on anticoagulant therapy

Food products can significantly affect the action of the anticoagulant; therefore, it is necessary to limit the consumption of foods containing a significant amount of vitamin K. Foods such as green tea and herbal infusions should be excluded from the diet. Cabbage (white cabbage, cauliflower, Brussels sprouts, broccoli), spinach, and greens (parsley, etc.) are indicated in small amounts. Regular alcohol intake significantly reduces blood clotting and can lead to bleeding.

Inform your attending physicians about the medications you are taking, as the anticoagulant interacts with many drugs, leading to an increase or decrease in its effect. Acetylsalicylic acid**, for example, must not be taken without consulting a doctor.

If the following symptoms appear, you must immediately consult a doctor and determine your INR:

1. appearance of hematomas on the skin ("bruises"),

2. blood in the urine,

3. bleeding from the nose or gums,

4. prolonged menstruation,

5. stool mixed with blood or black in color.

It is very important to reduce the amount of salt consumed, as fluid retention in the body may occur even after a successful surgery.

In addition to following certain rules when choosing food products, monitor your weight.

Infective Endocarditis of a Prosthetic Heart Valve

Infective endocarditis is an infectious and inflammatory disease that affects the heart valves or a prosthetic heart valve (prosthetic valve endocarditis). Prosthetic valve endocarditis is caused by bacteria (or more rarely fungi) that enter the bloodstream and settle on the synthetic cuff of the mechanical prosthesis, which can cause dysfunction.

The infection can enter the bloodstream due to various dental procedures (tooth extraction, prosthetics, and even cleaning), gynecological procedures (uterine curettage), urological procedures (cystoscopy), as well as due to skin suppuration.

To minimize the risk of contracting infective endocarditis, all patients with prosthetic heart valves must follow the following rule: on the eve of and shortly after the completion of any intervention that may introduce infection into the bloodstream (dental, gynecological, urological procedures, etc.), systemic antibacterial drugs should be taken prophylactically. Discuss with your attending physician which antibiotic you should take before the intervention.

When You Need to See a Doctor

Contact your doctor if you experience signs of infection, local or general (redness of the postoperative scar, discharge from it, fever, chills), increased fatigue, shortness of breath, edema, excessive weight gain, changes in heart rate rhythm, or any other signs or symptoms that seem dangerous to you.

From time to time, your treatment will be adjusted based on the results of your examination.

Appendix G. Assessment Scales, Questionnaires, and Other Evaluation Tools

The following questionnaire has been developed for the timely referral of a patient for a consultation with a cardiovascular surgeon. Each positive answer is scored one point. If a patient has 1 point or more for clinical symptoms combined with 1 point or more in the diagnostics section, they must be referred to a cardiac surgery center for a consultation with a cardiac surgeon; if they have 1 point or more only in the clinical symptoms section, they must be referred to a cardiac surgery center for a consultation with a cardiologist.

Appendix G1. Hospital Anxiety and Depression Scale (HADS)

Russian title: Hospital Anxiety and Depression Scale

Original title (if any): The Hospital Anxiety and Depression Scale

Source: Zigmond A.S., Snaith R.P. 1983 [131]

Type: rating scale

Purpose: assessment of the presence of anxiety (A) and depression (D) symptoms

Content (template): each statement of the HADS scale corresponds to 4 response options. The patient is asked to choose the response that corresponds to their state over the past 7 days, after which the scores are summed up separately for each part.

Table G-2. Hospital Anxiety and Depression Scale (HADS)

Note: A – anxiety subscale; D – depression subscale

Key (interpretation):

0–7 points - normal (absence of reliably expressed symptoms of anxiety/depression)

8–10 points - borderline abnormal anxiety/depression

11 points and above - clinically significant anxiety/depression

Appendix G2. Timed Up and Go test

Russian title: Timed “Up and Go” test

Original title (if any): Timed “Up and go” test

Source: Mathias S. et al. 1986 [132]

Type: test

Purpose: assessment of gait, balance, and fall risk

Content (template): required equipment: chair with armrests, tape measure, colored tape or marker, stopwatch. Measure a distance of 3 meters from the chair and mark it with a marker or colored tape so that the mark is visible to the patient.

Test conditions. The patient must be instructed that the test is timed. They may perform the first trial run without timing. During the test, the patient must wear their usual footwear and may use assistive devices that they normally use (e.g., a cane or walker). If necessary, the patient may stop to rest during the test.

Procedure (Figure G-1):

• The patient should sit in the chair with their back against the backrest and thighs fully supported by the seat. The chair must be stable. The patient is allowed to use the armrests when sitting and standing up.

• Patient instruction: When I say 'Go', you will need to stand up, walk the marked distance, turn around, return to the chair, and sit down. You should walk at your usual pace.

• Start timing after saying the word 'Go' and stop timing when the patient sits back down properly in the chair with their back resting against the backrest.

• During the test, pay attention to signs of gait and balance disorders.

Figure G-1. Diagram of the Timed Up and Go test procedure.

Key (interpretation): Normally, healthy older adults complete the Timed Up and Go test in 10 seconds or less. A result of more than 14 seconds in community-dwelling older adults, along with signs of gait and balance disorders, indicates a risk of falls.

Appendix G3. Original Borg Scale (Borg RPE, Rating of Perceived Exertion)

Russian title: Original Borg scale

Original title (if any): Borg Rating of Perceived Exertion

Sources: [133, 134]

Type: rating scale

Purpose: subjective assessment of physical exertion/training load tolerance

Table G-3. Original Borg Scale (Borg RPE, Rating of Perceived Exertion)

Key (Interpretation): The patient receives instructions on the subjective assessment of physical exertion / training load tolerance: from 6 points – virtually no effort, 9 – light walking pace, 12 to 14 – exertion equivalent to brisk walking or jogging; 15 and above – high-intensity zone, comparable to very fast running.

Appendix G4. CHA2DS2-VASc score

Russian title: CHA2DS2-VASc score

Original title: CHA2DS2-VASc

Sources: [170, 171]

Type: rating scale

Purpose: CHA2DS2-VASc is a clinical scoring system for assessing the risk of ischemic stroke in patients with non-valvular atrial fibrillation. It is used to guide decisions on anticoagulant therapy. It is recommended in international guidelines (ESC, AHA/ACC/HRS) as the basis for thromboembolic risk stratification [170, 171]

Content (template):

• C — Congestive heart failure — 1 point

• H — hypertension — 1 point

• A2 — age ≥75 years — 2 points

• D — diabetes mellitus — 1 point

• S2 — prior stroke or TIA — 2 points

• V — vascular disease (myocardial infarction, obliterating atherosclerosis, etc.) — 1 point

• A — age 65–74 years — 1 point

• Sc — female sex — 1 point

Maximum: 9 points

Key (interpretation):

• 0 points (in men) / 1 point (in women) — low risk; anticoagulant therapy is generally not required.

• 1 point (in men) / 2 points (in women) — moderate risk; the decision on therapy is made individually.

• ≥2 points (in men) / ≥3 points (in women) — high risk; anticoagulant therapy is indicated.

Clinical application: The scale is used for the initial assessment of a patient with atrial fibrillation and during follow-up monitoring. It helps justify the prescription of direct oral anticoagulants or vitamin K antagonists.

Appendix G5. EuroSCORE perioperative risk assessment scale

Russian title: EuroSCORE scale

Original title: EuroSCORE (European System for Cardiac Operative Risk Evaluation)

Sources: [148]

Type: rating scale

Purpose: EuroSCORE is a risk assessment scale for mortality after cardiac surgery

Content (template):

Age

• <60 (0 point(s))

• 60-64 (1 point)

• 65-69 (2 point(s))

• 70-74 (3 point(s))

• 75-79 (4 point(s))

• 80-84 (5 point(s))

• 85-89 (6 point(s))

• 90-94 (7 point(s))

• 95-100 (8 point(s))

Gender

• Female (1 point)

• Male (0 points)

Ejection fraction

• 30–50% (1 point)

• < 30 % (3 point(s))

• Renal impairment (2 points)

• Peripheral vascular disease (2 points)

• Respiratory disease (1 point)

• Cerebrovascular disease (2 points)

• Previous cardiac surgery (3 points)

• Active endocarditis (3 points)

• Critical preoperative state (3 points)

• Unstable angina (2 points)

• Recent myocardial infarction (2 points)

• Pulmonary hypertension (2 points)

• Emergency surgery (2 points)

• Surgery other than isolated CABG (2 points)

• Post-infarct ventricular septal rupture (4 points)

• Thoracic aortic surgery (3 points)

Key (interpretation):

Appendix G6. EuroSCORE II perioperative risk assessment scale

The EuroSCORE II (European System for Cardiac Operative Risk Evaluation) scale is designed to assess the risk of adverse outcomes in cardiac surgery (in this case, coronary artery bypass grafting). The table presents risk factors that increase mortality in cardiac surgical interventions. Each of these factors has been assigned a specific score. The EuroSCORE II risk indicator is calculated from the sum of these scores. In patients with a high EuroSCORE II score, PCI is advisable due to the high risk of complications and mortality following CABG surgery. This scale can be used to assess the risk of surgical interventions (including valvular heart disease) both with and without cardiopulmonary bypass.

Russian title: EuroSCORE II scale

Original title (if available): European System for Cardiac Operative Risk Evaluation II

Source: [149,150] (official website of the developers, validation publication: https://euroscore.org)

Type: rating scale

Purpose: assessment of the risk of adverse outcomes in cardiac surgery

Content (template):

EUROSCORE II PERIOPERATIVE RISK ASSESSMENT SCALE

Key (interpretation): the listed coefficients are substituted into the equation:

predicted mortality =

where B0 is the logistic regression constant, Bi is the variability coefficient of Xi, for age Xi = 1 if the patient is younger than 60 years, Xi increases by 1 for each year after 60 (at 61 Xi = 2, at 62 Xi = 3, and so on). CABG — coronary artery bypass grafting, MI — myocardial infarction, DM — diabetes mellitus, PASP — pulmonary artery systolic pressure, GFR — glomerular filtration rate (calculated by Cockcroft-Gault), CPR — cardiopulmonary resuscitation, HF — heart failure, CCS — Canadian Cardiovascular Society, NYHA — New York Heart Association.

Appendix G7. STS Score

Russian title: STS Score scale

Original title: The Society of Thoracic Surgeons Score

Sources: [147] (official website of the developers, validation publication: https://acsdriskcalc.research.sts.org)

Type: rating scale

Purpose: STS Score is a surgical risk assessment scale associated with CABG

Content (template):

• Low risk: less than 4%

• Intermediate risk: 4-8%

• High risk: 8% or more