ASSESSING QUALITY OF LIFE IN PATIENTS WITH SURGICALLY CORRECTED VALVULOPATHIES AFTER CARDIAC REHABILITATION

. Valvulopathy is a valvular disease that causes changes in the structure and dysfunction of the valvular system with impaired individual functionality and social impact. Surgical treatment consists in replacing the heart valve with a prosthesis using extracorporeal circulation. The most used prostheses are biological and mechanical, while homografts are less commonly used. Continuous progress in prosthesis valve technology has forced a reorientation towards conservative surgery and thus led to a new development of the cardiac rehabilitation process. An important aspect is the increasing proportion of patients with valvulopathies in general and particularly those which surgery, which raises the importance of postoperative cardiac rehabilitation. After surgical correction, even if the patient is sedated and intubated, the physiotherapist initiates the cardiac rehabilitation programme in accordance with the principle of early kinetic intervention so that recovery is achieved as quickly as possible at parameters that allow reintegration into family and socio-professional life. In this context, the aim of this research is to assess the quality of life of patients with surgically corrected valvulopathies after applying the cardiac rehabilitation programme to a sample of 30 people included in the case study. The methods used in this scientific research are: documentation, questionnaire (QLHR-Q10), observation and data processing. The findings highlight that the quality of life of patients with surgically corrected valvulopathies is average but it constantly improves as a result of adopting a healthy lifestyle and applying the cardiac rehabilitation programme.


Introduction
In the field of cardiac rehabilitation, information is needed regarding the consequences of heart disease on patients, as well as the effects associated with cardiac rehabilitation when valvulopathies are surgically corrected and for their subsequent assessment.
In the 70s, the concept of quality of life was defined in the social sciences, and then, in the 80s, it was integrated as a criterion to assess interventions in medicine and health.
The terms 'quality of life' and, more specifically, 'health-related quality of life' refer to the physical, psychological and social areas of health, which are seen as distinct areas influenced by the experiences, beliefs and expectations of a person (Brook et al., 1979).
Each of these areas can be measured in two dimensions:  objective assessments of functioning or health;  more subjective perceptions of health.
The objective dimension of health defines the degree of health of a patient and can be measured by objective assessments of functioning or health.The objective assessment of the real quality of life is given by the patient's subjective perceptions and expectations.
The International Society for the Study of Quality of Life has stated that quality of life includes both an objective and a subjective viewpoint and involves domains related to material well-being, health, productivity, affectivity, safety, society and inner well-being (Cummins, 2000).Thus, by defining quality of life, we include a reference to the patient's physical state, where health-facilitating behaviours are judged as predictors of the actual quality of life, and a subjective dimension related to the perceived level of satisfaction with the level of functionality.
According to the World Health Organization (2012), quality of life is an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.
It is a broad-ranging concept incorporating in a complex way the person's physical health, psychological state, level of independence, social relationships and relationship with salient features of their environment.
In the World Health Organization's vision, quality of life is specified by perceptions of physical, psychological and emotional health, the degree of personal independence, social relationships and the type of interaction with one's context.It can be noted that this construct is broader than health and therefore is not a synonym for health.It is also important to point out that the World Health Organization's definition of this concept connects elements from an enormous amount of research.
Considering the above, we can state that being healthy is one of the dimensions of quality of life, and behaviours that facilitate health are thought to be predictors of quality of life.At the same time, the definition of quality of life always includes a reference to an individual's physical condition, but it is not assessed only on the basis of an individual's body functions that can be measured using standard parameters, being described in relation to the perceived level of satisfaction with the level of functionality.This type of definition shifts the focus from objectively definable functionality to the dimension of subjectivity; detecting these two aspects can be a reliable measure of quality of life (Irtelli & Durbano, 2020).
In addition, we can see that the most common method of measuring quality of life is the administration of questionnaires and that there are two types of questionnaires, namely generic and pathology-specific ones (Irtelli & Durbano, 2020).
The identification of health indicators that provide the necessary and appropriate data for the assessment of clinical outcomes in terms of health-related quality of life, as established by the World Health Organization through the biopsychosocial model that provides adequate and relevant information on physical, mental and social factors in patients, can improve the decision-making process in relation to a global and comprehensive perspective of the clinical outcomes of different cardiac rehabilitation protocols.
Over the past decades, numerous tools have been developed and applied to measure the effects of health-related quality of life on patients based on biological or physical aspects, psychological or mental aspects and social aspects (Mirón Canelo et al., 2021).
The concept of quality of life is confused with the concept of health, but this is wrong because the term 'health' is not enough to explain quality of life, so two classes of complementary health measures have emerged in recent years: objective measures for functional health and subjective measures for health and well-being.A really important assessment scale is the World Health Organization Quality of Life Scale, which measures this specific area by examining the responses given by patients on a Likert scale (Irtelli & Durbano, 2020).
In this context, the aim of this research is to assess the quality of life of patients with surgically corrected valvulopathies after applying the cardiac rehabilitation programme.

Valvulopathies
Valvulopathy is a pathological valvular disease in isolation or in the context of other diseases, leading to changes in the structure and dysfunction of the valvular apparatus.Both international and national literature include several studies on valvular heart disease (VHD), valvulopathies, but most of them discuss issues related to epidemiology, pathophysiology, systematisation of types and subtypes of these diseases and drug treatment.
At present, there are few studies in the field of valvulopathies compared to other cardiac diseases, and randomised trials are even very rare.The same is true for specialised guidelines, so there is only one guideline for valvulopathies in the US and four national guidelines in Europe.Moreover, published guidelines are not always consistent due to the lack of both randomised clinical trials and constant progress in clinical practice.
The guidelines for the assessment and treatment of valvulopathies developed by the Task Force for the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association of Cardio-Thoracic Surgery (EACTS) specify the following (Baumgartner et al., 2017):  the decrease in the incidence of rheumatic fever due to streptococcal infection prophylaxis explains the decrease in the incidence of rheumatic valvulopathies, while the increase in life expectancy is at least partly responsible for the increase in the incidence of degenerative valvulopathies in industrialised countries;  due to the prevalence of degenerative valve diseases, the most common valve diseases are aortic stenosis and mitral regurgitation, while aortic insufficiency and mitral stenosis are less common.Older age is associated with an increased frequency of comorbidities that contribute to increased operative risk and complicate the decision to correct valve disease;  a primary diagnostic method today is echocardiography, which has become a standard for the structural and functional assessment of the heart valve and to determine the severity and prognosis of valvulopathy;  treatment methods have evolved not only through continued progress in prosthetic valve technology but also through a shift towards conservative surgery and the implementation of percutaneous intervention techniques;  an important aspect of current valvular diseases is the increasing proportion of patients undergoing surgery, which raises the importance of postoperative rehabilitation.In Romania, the most common valvular disorders are aortic stenosis and mitral insufficiency, which are surgically corrected by the classical approach through median sternotomy, and more recently, by minimally invasive cardiac surgery.
According to Vahanian et al. (2021) aortic stenosis is the most common primary valvulopathy in Europe and North America requiring surgical or transcatheter intervention.
Early therapy should be strongly recommended in all symptomatic patients with severe aortic stenosis because of their dismal spontaneous prognosis (Baumgartner et al., 2017).
Mitral regurgitation is the second most frequent indication for valve surgery in Europe (Iung et al., 2003).Mitral regurgitation may result from disorders of the valve leaflets themselves or from any of the surrounding structures that comprise the mitral apparatus.The leading cause of mitral regurgitation is rheumatic heart disease in developing areas of the world and degenerative forms of mitral valve disease (myxomatous disease and fibroelastic deficiency) in the United States and other developed countries (Maganti et al., 2010).Similarly, asymptomatic patients with severe mitral regurgitation should be considered for surgical correction, especially if the valve can be repaired, after discussions about the benefit of early referral for surgery.The timing of the surgical correction is largely related to whether the patient is a candidate for mitral valve repair or will need mitral valve replacement (Maganti et al., 2010).

Prostheses
Surgical treatment involves replacing the heart valve with a prosthesis using extracorporeal circulation.According to Brandt and Pibarot (2021), the most commonly used prostheses are biological and mechanical, while homografts (harvested from cadavers) are less used:  biological prostheses are manufactured from bovine or porcine pericardium and are also called bioprostheses.The first bioprostheses used were less durable than mechanical prostheses but had the advantage of not needing lifelong anticoagulant treatment to prevent blood clots on the valve surfaces.Today, these bioprostheses tend to equal the lifespan of mechanical prostheses, which is why they are increasingly preferred.The average life expectancy of a state-of-the-art bioprosthesis is more than 15 years for 3rd generation valves;  mechanical prostheses have proven to be extremely durable, with a life expectancy of 20 to 40 years.However, mechanical valves require lifelong anticoagulant treatment to prevent blood clots from forming on the valve, otherwise these clots, once formed, can be dislocated causing embolic strokes in the brain or other parts of the body (Brandt & Pibarot, 2021).
Mechanical heart valves (MHV) are made entirely of non-biological (artificial) materials including metals (titanium, cobalt), pyrolytic carbon and polymers in order to provide mechanical stability and durability.Different types of MHV include caged ball valves such as the Starr-Edwards valve, tilting disc valves, e.g., the Björk-Shiley and Medtronic valves, and bileaflet valves such as the St. Jude Medical valve with various modifications on these designs.Caged ball valves are no longer implanted; bileaflet valves are the most common type used today.The primary components in this type are usually a fabric-covered sewing ring, stent, hinge, and two occluders (also called discs or leaflets) in order to be effective as a one-way valve (Brandt & Pibarot, 2021).
The orientation of a bileaflet MHV influences intraventricular haemodynamics.An antianatomic orientation (the MHV hinge line oriented towards the left ventricular [LV] outflow tract and not parallel to the commissure line of the native valve) is associated with a more favourable LV flow pattern (Van Rijk-Zwikker et al., 1996).
Bioprosthetic valves (BPV) are, at least partially, made of animal tissue (e.g., porcine, bovine or equine) (heterogeneous or xenograft) or human (homograft or allograft) mounted on a three-pillar metal or polymeric support structure (also called struts) and have a trileaflet configuration that resembles the geometry of a native aortic valve.While porcine aortic valves can be harvested whole while maintaining the natural attachments of the pavilions (valve hinges), the bovine or equine pericardial tissue must be cut and fixed on a stent to mimic the functional architecture of the valves (Brandt & Pibarot, 2021).
To reduce immunogenicity and prevent rejection of the humoral or cellular immune system when implanted in the human body, valvular or nonvalvular tissue valves of animal origin are fixed in glutaraldehyde, a process that binds and masks antigens and makes the tissue valve biocompatible (Schoen & Levy, 2005).

Surgical correction of valvulopathies
Surgical correction of valvular diseases by surgical replacement of the valve or repair of the mitral valve is currently the standard of care for the treatment of heart valve disease in patients at low and medium risk for surgery.Thus, surgery was the main treatment for heart valve disease, but transcatheter valve therapy has grown exponentially over the past decade.Given these, a development of transcatheter technologies has been observed in the last 10 years, which now offers alternative surgery, especially in high-risk or prohibitive patients (Dangas et al., 2016).
Transcatheter valve therapy for aortic stenosis and mitral regurgitation is currently a treatment option for patients who are not suitable for conventional surgical treatment or have at least an intermediate risk of aortic surgery (Nishimura et al., 2014).There are two types of artificial heart valves: mechanical heart valves, which are surgically implanted, and bioprosthetic heart valves, which can be implanted through a surgical or transcatheter approach (Dangas et al., 2016).
In Romania, the most common valvular disorders are aortic stenosis and mitral regurgitation, which are surgically corrected through the classic approach by median sternotomy and, more recently, by minimally invasive cardiac surgery.
Procedures in case of surgically corrected valves (Masson et al., 2009):  median sternotomy is the main approach in cardiac surgery, being used in over 90% of heart surgeries.It is performed by incising the skin and subcutaneous cellular tissue to approach the sternum.The actual sternotomy is then performed using an electric sternotomy, an instrument that is basically a medical electric saw.The advantages of this approach are complete exposure of the heart, pericardium and the origin of the great vessels.At the end of the operation, sternography is performed, i.e., suturing the sternal edges using wires of different thicknesses, which pass through the sternum or intercostal spaces, close to the lateral edge of the sternum;  aortic valvulopathies, the most common category, when reaching stages that require valve replacement, can be treated by minimally invasive surgery or ministernotomy, in which only the initial portion of the sternum is cut, or by a right anterior minithoracotomy, depending on the anatomy of the internal thoracic structures.These are also less traumatic interventions for patients, especially since they are sometimes old people with low functional reserves.Surgical scars have a lower risk of difficult healing.Recovery after surgery is easier, and movement restrictions are lighter;  the choice of the procedure must take into account the cardiac and extracardiac characteristics of the patient, the individual risk for surgery (assessed by the interdisciplinary team), risk scores, the feasibility of a transcatheter aortic valve implantation procedure (transcatheter implantation of the aortic valve), local experience and data results;  transcatheter aortic valve implantation is a minimally invasive interventional cardiology procedure in which an aortic valve prosthesis can be implanted via a transcutaneous transfemoral approach to remove the obstacle posed by the native stenotic aortic valve.Despite being less invasive than open-chest aortic valve replacement, transcatheter aortic valve implantation remains associated with the potential for serious complications.

Cardiac rehabilitation programme for patients with surgically corrected valvulopathies
By increasing the comfort of contemporary human beings, today's modern society is facing a paradox: the current high level of comfort combined with an increasing lack of physical activity is the main source of many cardiovascular diseases, the most common of which are strokes and coronary heart disease.As highlighted by the World Health Organisation (2021) in official documents, worldwide cardiovascular diseases are the leading cause of death, with an estimated 17.9 million people dying in 2019, representing 32% of all global deaths.Wenger (1986) was the first to propose a cardiac rehabilitation programme in the late 70s, when the early mobilisation of the patient was recommended for the first time.The aim of this programme was to move the patient from supine to a standing position, and then to make the patient move over 14 days.
Patients with surgically corrected valvulopathies have difficulty performing physical effort, even within usual intensity limits.The state of health and the lack of exercise imposed by cardiac surgery cause several functional disturbances of the whole body, particularly the maladjustment and imbalance of the cardiorespiratory, metabolic, muscular systems, etc.Failure of the patient with surgically corrected valvulopathies to adapt to physical effort requires a rehabilitation protocol that includes pulmonary, cardiac and musculoskeletal rehabilitation vectors, resulting in the cardiac rehabilitation programme.Thus, the cardiac rehabilitation programme becomes a sports-type training programme defined as a systematic and constantly graded pedagogical process of body adaptation to physical and mental effort.
The objectives of the cardiac rehabilitation programme for patients with surgically corrected valvulopathies are:  increasing the exercise capacity;  relieving symptoms;  achieving family, social and professional reintegration;  increasing the patient's life expectancy and quality of life, thus reducing the risk of morbidity and mortality.The studied group of patients with surgically corrected valvulopathies was treated with the trinomial cardiac rehabilitation programme:  a pulmonary rehabilitation protocol, where, through respiratory rehabilitation, the physiotherapist chooses and applies conventional respiratory clearance procedures;  a cardiac rehabilitation protocol, where effort readjustment of the patient with surgically corrected valvulopathies is a particularly important goal.For the patient, exercise capacity is the maximum amount of mechanical work performed in a unit of time.According to Cordun (2011), exercise capacity is not the sum of the functional abilities of all organs and systems of the human body;  a musculoskeletal rehabilitation protocol, whose objectives are: -early mobilisation of the patient in order to avoid the harmful effects of prolonged rest; -increasing the functional ability of the musculoskeletal system (range of motion, muscle properties).The cardiac rehabilitation programme is the sum of the rehabilitation exercises in the rehabilitation protocols and is based on the guidelines and public health recommendations for physical activity in patients with heart disease included in the cardiac rehabilitation trials (Wenger, 1986;Iung et al., 2003;Sumide et al., 2009;Price et al., 2016;Seo et al., 2017).

Participants and Procedure
Using a specific questionnaire, we conducted a cross-sectional assessment of the quality of life for 30 patients with surgically corrected valvulopathies in a private unit specialising in cardiac surgery, located in Bucharest, Romania.This hospital has the advantage of a fully equipped physiotherapy room for the cardiac rehabilitation of patients with surgically corrected valvulopathies.The hospital also has the necessary equipment to perform and monitor the tests included in the cardiac rehabilitation programme for patients with surgically corrected valvulopathies.
All clinically stable patients after valvular surgery were considered eligible for the study.Patients with cognitive or language problems, major psychiatric disorders or other lifethreatening chronic or acute concomitant illnesses were not included.
Patients underwent a cardiac rehabilitation programme and were assessed after two weeks being asked to complete a quality of life questionnaire.
This prospective study was conducted between November 2021 and February 2022 in a private hospital unit specialising in the cardiovascular field.The participants were 30 patients with surgically corrected valvulopathy, who performed a cardiac rehabilitation programme for 14 days.The mean age of the study participants was 62.3 (SD = 3.1) years, and more than half of them (n = 17; 56.7%) were women (Table 1).As can be seen in Table 1, the level of education is predominantly average (53.3%),followed by patients with higher education (26.7%).

Measurements
We designed a 10-item questionnaire (QLHR-Q10) to allow patients with surgically corrected valvulopathies to assess various aspects of their quality of life by using questions related to: Health perception, Physical health, Daily activities, Social and lifestyle.The responses were given on a Likert scale (of 1 to 5, where 1 -low rate and 5 -high rate).
We asked patients to respond to 10 questions to assess their quality of life after valve correction surgery and after completion of the cardiac rehabilitation programme.
In developing the QLHR-Q10 questionnaire, we used information from the World Health Organization Quality of Life Scale-100 (WHOQOL-100) (The WHOQOL Group, 1998) and Quality of Life BREF Scale (WHOQOL-BREF), which is a 26-item version that summarises the WHOQOL-100.The WHOQOL-100 and WHOQOL-BREF are useful in clinical settings, medical practices, audits and policy making to assess the effectiveness of various treatments.
From the QLHR-Q10 questionnaire, the specialist wants to know how much the quality of life of the patient with surgically corrected valvulopathy has been influenced after the twoweek cardiac rehabilitation programme.
The QLHR-Q10 questionnaire used in the study is divided into four categories: 1. Health perception (2 items); e.g., How would you rate your quality of life?, How do you feel about your health?, etc.
2. Physical health (3 items); e.g., How do you feel after 5 minutes of easy walking?, How do you feel after climbing a floor?, etc.
3. Daily activities (3 items); e.g., Do you have enough energy for everyday life?, How well do you sleep?, etc.
4. Social and lifestyle (2 items); e.g., How important is it for you to continue the home rehabilitation programme?, etc.

Results
Translating different areas and components of health into a quantitative value that indicates quality of life is a complex task, using knowledge from the fields of clinometry, psychometry and clinical decision theory (Testa & Simonson, 1996).Table 2 summarises the data from the QLHR-Q10 survey for patients with surgically corrected valvulopathies.Using the Mann-Whitney test, we checked whether there were significant differences between men and women based on their responses to the QLHR-Q10 questionnaire.According to Table 3, no significant differences were found considering gender differences at the significance threshold of p < 0.05; even if there are no significant differences (p > 0.05) in this respect, the following important differences can be found between men and women:  women feel better about their health compared to men (Mwomen = 2.35; Mmen = 2.07);  women feel better after climbing a floor compared to men ((Mwomen = 3.17; Mmen = 2.69);  women tend to be less resistant to physical pain compared to men (Mwomen = 2.05; Mmen = 2.46);  women tend to have more energy throughout the day than men (Mwomen = 2.47; Mmen = 2.30);  women and men rate their condition after 5 minutes of easy walking similarly (Mwomen = 3.17; Mmen = 3.15);  women and men rate their level of quality of life relatively similarly (Mwomen = 2.58; Mmen = 2.61);  the level of satisfaction with the ability to carry out daily activities is relatively similar for women and men (Mwomen = 2.82; Mmen = 2.85);  in terms of sleep quality, the differences between men and women are insignificant (Mwomen = 2.41; Mmen = 2.46);  the time spent on daily exercise is almost similar for women and men (Mwomen = 2.64; Mmen = 2.69);  both groups show interest in continuing the rehabilitation programme at home, but men give more importance to this work (Mwomen = 3.94; Mmen = 4.23).

Discussion and Conclusion
The results obtained in the Physical health and Daily activities categories validate the usefulness and necessity of the cardiac rehabilitation programme for patients with surgically corrected valvulopathies.
Through the majority of responses given to the question: How important is it for you to continue the home rehabilitation programme?, patients validated the importance and necessity of continuing the cardiac rehabilitation programme at home.
The findings highlight (even if the differences are not statistically significant) that: o women feel better about their health compared to men and also feel better after climbing a floor; o women tend to have more energy throughout the day than men; o women tend to be less resistant to physical pain compared to men; o the time spent on daily exercise and the reported sleep quality are relatively similar for women and men; o women and men rate their level of quality of life almost similarly; o both groups show interest in continuing the rehabilitation programme at home, but men give more importance to this work.In conclusion, the results of the study indicate that participation in a cardiac rehabilitation programme (after valve correction surgery) is overall beneficial for patients' quality of life.These results are in agreement with other studies (Lourens et al., 2022;Antonakoudis et al., 2006;De Bakker et al., 2020) that have shown the positive effects of cardiac rehabilitation programmes on assessing quality of life in cardiac surgery patients.
Authors' Contribution: All authors have equally contributed to this study.

Institutional Review Board Statement:
The study was conducted in accordance with the Declaration of Helsinki and approved by the Ethics Committee of the National University of Physical Education and Sports in Bucharest, Romania (ID: 51/1701).

Informed Consent Statement:
The participants provided their written informed consent to participate in this study.

Table 1 .
Basic characteristics of patients

Table 2 .
Distribution of QLHR-Q10 questionnaire responses In the Daily activities category, responses to the question: Do you have enough energy for everyday life?show a majority distribution to Level 2 (43.3) and Level 3 (33.3); In the Social and lifestyle category, the question: How important is it for you to continue the home rehabilitation programme?indicates, through the majority of responses given, that 24 patients (80%) are aware of the importance of continuing the cardiac rehabilitation programme at home.

Table 3 .
Gender differences obtained from the tracked items