Journal of Cardiovascular Nursing:
ARTICLES: State of the Science Reviews
Critical Review of Health-Related Quality of Life Studies of Patients With Aortic Stenosis
Nugteren, Laura Beth MA, RN, CCRN; Sandau, Kristin E. PhD, RN
Laura Beth Nugteren, MA, RN, CCRN Staff Nurse, Intensive Care Unit, Mercy Hospital, Coon Rapids, Minnesota.
Kristin E. Sandau, PhD, RN Associate Professor, Nursing Department, Bethel University, St Paul, Minnesota.
Corresponding author Laura Beth Nugteren, MA, RN, CCRN, Mercy Hospital, 4050 Coon Rapids Blvd., Coon Rapids, MN 55433 (email@example.com; firstname.lastname@example.org).
Background: While studies of health-related quality of life (HRQOL) are increasing among cardiovascular patients, very few have examined HRQOL in persons with aortic stenosis (AS).
Purpose: A critical review of studies (1997-2008) of HRQOL in persons with AS was conducted to summarize findings and identify clinical and research implications.
Results: Twenty-eight studies were identified, all of which were quantitative and evaluated HRQOL after aortic valve replacement (AVR). No studies conducted by nurses or studies measuring HRQOL in persons who did not undergo AVR were found. The literature focused on age and type of valve as variables influencing HRQOL postoperatively. Although results varied, elderly patients often scored similar or better than comparison groups. Health-related quality of life was found to be affected by valve noise and anticoagulation rather than the specific valve type when comparing patients receiving biological versus mechanical valves.
Conclusions: Selection for surgery should not be based on age alone. Early consideration should be given to symptoms prior to surgery because of evidence that patients with fewer symptoms preoperatively have better HRQOL after AVR. Anticoagulation status should be evaluated as an independent variable of HRQOL in future studies.
Implications for Research and Practice: Researchers need to augment generic HRQOL measures with disease-specific items that may pertain to life areas affected by AS, such as audible valve click, wound healing, and dyspnea. Future research should be inclusive of AS patients who do not undergo surgery. Nurses in a variety of roles can work independently or within a multidisciplinary team to provide interventions for the promotion of HRQOL for patients across all stages of the AS disease process.
According to Lam and Hendry,1 aortic stenosis (AS) has become the most common valve disease in adults in Europe and the United States. Calcific AS is found in 2% to 4% of adults 65 years or older.2 The most common cause of AS is a degenerative-calcific process, which results in leaflet immobility and impaired blood flow through the heart.2 The body typically adapts through a hypertrophic process that results in left ventricular wall thickening to overcome the obstruction and maintain normal chamber volume.3 The natural prolonged latent period, during which patients remain asymptomatic, varies from patient to patient. Over time, the body's natural compensation measures prove to be inadequate as increased wall stress and high afterload cause a decrease in ejection fraction. Symptoms of heart failure, including angina and syncope, may subsequently present. After the onset of symptoms, average survival is 2 to 3 years in patients who do not undergo aortic valve replacement (AVR), with a high risk of sudden death. According to Bonow et al,3 for adults with severe, symptomatic, calcific AS, AVR is the only effective treatment. As reported in Freeman and Otto,2(p3321) "…symptomatic patients who undergo aortic valve replacement have an age-corrected postoperative survival that is nearly normalized."
Congenital abnormalities may include the aortic valve being composed of only 2 cusps and therefore termed bicuspid. Approximately 1% of the population has a bicuspid aortic valve.4 The same calcification process that causes stenosis of a normal tricuspid aortic valve also affects the bicuspid valve. According to Cowell et al,5 patients with a bicuspid aortic valve who develop valvular stenosis will require AVR 1 to 2 decades earlier in life compared with those with a tricuspid aortic valve. In addition, rheumatic heart disease, caused by rheumatic fever, can also contribute to AS. Recent developments in treating streptococcal throat infections have decreased the prevalence of rheumatic heart disease in the United States. The death rate from rheumatic fever/rheumatic heart disease decreased by almost 39% from 1995 to 2005.6
As the population ages, nurses will care for more elderly patients seeking treatment for AS. Average in-hospital mortality doubles for AVR in patients older than 65 years, resulting in an 8.8% in-hospital mortality.3 According to Bonow et al,3 quality of life (QOL), rather than longevity, is the goal of therapy for patients with AS. For this literature review, health-related QOL (HRQOL) will be defined as a "subset of quality of life representing satisfaction in areas of life likely to be affected by health status; HRQOL is subjective, multidimensional, and temporal."7(p273) Furthermore, HRQOL should assess the perspectives of the patient rather than the clinician because patient perspectives can change with health altering satisfaction in areas of life such as physical, emotional, social, mental, and spiritual domains. As elderly patients seek treatment for AS, nurses and physicians need to guide their care based on potential for improvement in HRQOL rather than basing treatment options on age alone. Because no existing systematic review was found for this specific patient population, the purpose of this article was to critically review the current literature of HRQOL for patients with AS to provide nurses with an increased understanding of the problems facing this population.
Research studies from 1997 to 2008 were searched from the databases of PubMed/MEDLINE, Cochrane, Academic Search Premier, and CINAHL. Key words included a variety of combinations of "aortic stenosis," "quality of life," "health-related quality of life," "health related quality of life," and "aortic valve." The studies identified through this search were supplemented with others found with the review of the literature from a current study evaluating HRQOL in AS. Five additional studies, meeting the same criteria, were found by reviewing the titles of articles in the reference lists of these articles. A total of 28 studies met the criteria and were included in review of the literature. No studies were found that were directed by nurse researchers. No qualitative studies were found.
Inclusion and Exclusion Criteria
This review focuses on studies that have evaluated HRQOL on adult patients with AS or aortic repair or replacement. Only studies that measured at least 3 different domains were included in the matrix, as the assessment of at least 3 domains is necessary to accurately reflect the multidimensional nature of QOL.8 Therefore, 7 studies were excluded because of their focus on the functional domain alone and failure to measure 3 domains.9-15 To ensure that HRQOL subjective data were obtained, only studies that performed measurement by patient self-report (as opposed to clinician report) were included. Therefore, 1 study was excluded because QOL was operationally defined through means of chart extraction for items such as delirium, pain medication use, and timing of return to usual activities.16
Studies were excluded if they pertained to pediatrics or did not study QOL measures. Because of the minimal number of articles found, studies were included if the study participants underwent AVR with or without concomitant coronary artery bypass grafting or other valvular surgeries. Studies were included even if only part of the study population underwent aortic valve surgery. In such studies, the other study participants had another type of cardiac surgery: either a valve replacement or coronary artery bypass grafting. One study was excluded because it included patients undergoing AVR in the randomization process, but not in postoperative testing.17
A total of 28 research studies were included for final review (Table 1). Pertinent information has been summarized in matrix form. Because AVR is the treatment of choice for AS, evaluating HRQOL among patients following AVR has received primary focus. The variables measured in the majority of studies have been age and valve selection.
QOL Definitions and Domains
The lack of clear conceptual definitions of QOL is a weakness throughout the literature. Because of instrument variation and confusion among appropriate QOL measures, it is important for the researcher to define the concept of HRQOL or QOL and identify the domains being measured in the study.
All of the articles identified the QOL domains being measured with the exception of Podolec et al.18 Because of variations within the assessment tools used, the categories of domains differ slightly. A major strength of these articles was the inclusion of enough domains (such as physical, emotional, and social) to adequately make a holistic assessment.
Twenty-two (77%) of the studies used at least part of the Medical Outcomes Study (MOS)19 to evaluate participants. Four of the studies used the Nottingham Health Profile.20 The MOS and Nottingham Health Profile are broad generic measures (not created for a specific population or disease) and allowed for ease of comparison. However, an argument could be made that the use of a disease-specific instrument rather than a generic measure would be helpful for considering the specific concerns within this population. Alternatively, investigators could augment a generic instrument by adding disease-specific measures to evaluate the symptoms specific to AS. For example, the Minnesota Living With Heart Failure is a disease-specific instrument that has been used in combination with the MOS Short-Form 36 to evaluate HRQOL in patients undergoing interventions for heart failure.21,22 At this time, there is no disease-specific measure for HRQOL in AS. Some researchers have augmented generic measures with investigator-developed questions to assess patient perceptions of valve-specific concerns such as audible valve click, effects of lifetime anticoagulation, fear of reoperation, or dyspnea.23-28 One investigator comprehensively evaluated QOL using solely author-developed questions. However, no reliability or validity was provided regarding the questionnaire, nor was a conceptual definition provided.18
All of the studies identified were quantitative studies. The lack of qualitative studies represents a gap in the literature evaluating the AS patient population. In the rush to provide quantitative comparisons for age and valve type, researchers failed to first validate their measures in the AS population. Ideally, any quantitative measurement in a population should be built on qualitative studies using domains that patients have identified as important in their condition. Researchers have used generic and global measures without verifying if the patients feel that these measures accurately evaluate their QOL. Currently, there is no specific disease measure for HRQOL in the AS population. Qualitative studies have a significant role in the development and validation of instruments used for quantitative studies.29
Only 7 (25%) of the studies were prospective that would have allowed for baseline data to be collected and compared with the postoperative QOL data.1,24,27,30-33 Even among the prospective studies, "baseline" data were not always obtained prior to surgery, thus creating a risk of recall bias. The lack of baseline data is a weakness in the literature as retrospective comparisons make it difficult to assume QOL changes among a study sample after the intervention.
Six studies (21%) were identified as long term, with the longest follow-up being 30 years postoperatively.18,27,34-38 Overall, studies in this review made assessments most frequently between 30 and 36 months. For patients following major surgery, allowing time for adequate postoperative healing and returning to normal activities is crucial in accurately measuring HRQOL. However, the overall range over which QOL assessments were taken was prolonged in many studies. For example, Pupello et al39 collected follow-up data on patients between 1 month and 23 years after their hospital discharge from surgery. This is a disadvantage as timing from surgery could impact the patient's HRQOL, thus making comparisons inaccurate. Waiting too long after a procedure to evaluate changes in HRQOL may reduce the accuracy of assessment or opportunity for follow-up.
Patients were lost to follow-up because of lack of participation or death or they no longer met the inclusion criteria. For this review, follow-up percentages were calculated with inclusion of reported deaths to more accurately reflect the true response rate (Table 1). The percentage of patients who completed follow-up is provided, along with the original sample size. Follow-up percentages for the studies ranged from 22% to 96%.
Treatment Options Across Disease Trajectory
The greatest gap in the literature topic included the failure to evaluate patients with AS who have not undergone AVR. To fully grasp the temporal characteristic of both HRQOL assessment and the changes with chronic illness, researchers need to evaluate HRQOL at all stages of AS from the diagnosis and onset of symptoms through various treatment modalities. The literature is lacking in discussion of HRQOL for those who are not surgical candidates or choose alternative therapies. Another unexplored area is the use of nonsurgical means, such as nursing interventions to promote HRQOL. Nursing interventions for those with AS could potentially include education, support groups, screening, and prevention of decreased HRQOL related to falls or depression. These are major limitations within the literature and point to areas for future research.
Not all studies identified AS as the primary reason for surgery. Similarly, postoperative results of patients who received AVR were often reported combined with results of other cardiac surgeries. Because of the lack of studies investigating isolated AVR, studies that included even a portion of AVR patients were analyzed. Regrettably, 12 (43%) of the studies included in this matrix did not provide clear baseline data on the percentage of participants who had a diagnosis of AS preoperatively.18,23,24,26,27,35,36,39-43 Of those studies that provided data on preoperative diagnosis of AS, actual percentages for patients with AS ranged from 54.1% to 100%.
Adequacy of Comparison Populations
Seven (25%) of the studies used the general population as the only comparison group.26,34,36,39-41,44 Comparison populations were most often matched for age and, only occasionally, for sex and race. Melnyk and Fineout-Overholt45 warn clinicians that significant differences between the general population and study sample may make accurate comparisons difficult.
Most studies evaluated data from samples in single centers. Surgeon and staff experience and technique, policies and procedures, and equipment are only a few of the potential confounding variables that must be considered. Evaluation at a single center may limit generalizability of the study results. Furthermore, systematic bias results when a sample is not selected randomly from the target population. Many of the studies in this review were nonprobability or convenience samples that precluded generalizations beyond the sample.
Practice and Research Implications
Recommendation for practice and research are presented in Tables 2 and 3. Research recommendations were obtained directly from an evaluation of the strengths and weaknesses of the existing literature. Practice recommendations are practical guidelines based on the evidence of current findings. However, current recommendations for nursing practice and research are limited by the fact that the existing literature has focused on surgical outcomes.
Most articles reviewed identified age as the predominant variable in the study. Patients who had undergone AVR were commonly compared with their baseline, younger cohorts or an age-matched population norm. While QOL results varied depending on the specific study and domain being measured, older surgical candidates often scored similar or better than the comparison groups.1,24,28,30,31,34,36,40,41,44,46,47 Based on these results, the acceptance or refusal for AVR should not be based on age alone. Notably, authors surmised that the advanced illness of participants prior to surgery may alter study findings as participants report inflated postoperative improved health status when compared with reports of healthy elderly who compare current health status with what they experienced in their youth.48 The positive results for HRQOL for the elderly after AVR are encouraging. However, increased risk for morbidity and mortality should receive concurrent discussion when surgeons and nurses are assisting patients with preoperative decision making.
In regard to factors that contributed to negative QOL scores, a number of preoperative characteristics and comorbidities were identified. Baberg et al44 found that patients with combination regurgitation and stenosis, diabetes mellitus, chronic obstructive pulmonary disease, or New York Heart Association (NYHA) class III or IV had significantly lower QOL scores postoperatively. Furthermore, preoperative depression was also associated with lower QOL scores postoperatively.24 While no interventional studies for depression among AS patients were found, clinicians have noted the importance of addressing the psychological and spiritual domains in other chronic patient populations. For example, among outpatients with heart failure, greater spiritual well-being (particularly meaning and peace) was strongly associated with less depression.49 Spiritual well-being as well as depression could be important modifiable variables to study among patients with AS.
According to Bonow et al,3 AVR should be performed promptly at the onset of symptoms. Baberg et al44 found that those patients with a NYHA class III or IV preoperatively scored significantly lower in physical functioning, degree of physical health to perform age-typical activities, bodily pain, general health, vitality, social functioning, and mental health when compared with the general population at AVR postoperative follow-up. Meanwhile, patients with a preoperative NYHA class I or II had comparable postoperative results with the general population. Prepared with this knowledge, nurses need to educate patients to promptly report symptoms of syncope, angina, and dyspnea.
Valve selection is based on a number of contributing factors including life expectancy, lifestyle, patient preference, risk of reoperation, risk of bleeding, and ability to take anticoagulants.50 Each type of valve comes with advantages and disadvantages. Anticoagulation is a lifelong essential for all patients with a mechanical valve and is required long term by some patients with a biological valve because of comorbidities. The major disadvantage of biological valves is the risk of deterioration and need for reoperation. Valve deterioration is age related, causing increased risk for younger patients.3
While many options exist in valve selection, the majority of literature focused on QOL assessment using mechanical versus biological valves. The review found mixed results on overall QOL analysis. However, interesting information was gained about patient perceptions, especially regarding anticoagulation. Florath et al26 compared QOL scores of patients who had undergone AVR. The authors found no significant differences between the patients receiving stentless biological valves and those patients receiving mechanical valves. However, upon examining subgroups, investigators found that patients requiring anticoagulation had a nearly 2-fold increased risk for a negative emotional reaction. Perchinsky et al23 and Podolec et al18 found that patients following a mechanical valve replacement were bothered by the valve sounds. There was a negative correlation between valve sound and QOL scores on the mental summary score of the MOS SF-12.23 In addition, Perchinsky et al23 reported that almost none of the patients could remember being told prior to surgery that they may hear mechanical sounds after the operation. Perchinsky et al23 also found that the mechanical group had a negative correlation between fear of reoperation and QOL on the physical summary scale. The fear of reoperation for the biological bioprosthesis group was not correlated with QOL. Florath et al26 speculated that the constant reminder of the mechanical valve due to valve sounds, blood sampling for anticoagulation regulation, and lifestyle and professional limitations due to bleeding risks led to an impaired health perception. Early education by nurses regarding postoperative expectations including integration of anticoagulation into personal lifestyles may limit anxiety and fears of valve malfunction.
Atrial fibrillation and wound infections were identified by Baberg et al44 as postoperative complications that were associated with lower QOL scores in varying domains. Furnary et al51 reported that hyperglycemia in the postoperative patient may be an independent predictor of deep sternal wound infections. The use of a continuous insulin infusion for strict glucose control versus intermittent subcutaneous insulin injection has proven to have a significant decrease in the risk of deep sternal wound infections.51 Nurses are instrumental in implementing this standard of care to reduce postoperative wound infection.
Nurses have an opportunity to influence future HRQOL research among the population of patients with AS. Research in this area is ongoing as surgeons explore percutaneous valve replacement and material engineers work to develop a mechanical valve that would not require anticoagulation. Nurses are well positioned to HRQOL assessment because of their common focus on holism and well-being.7 Furthermore, nurses can work collaboratively with other disciplines providing HRQOL insight into existing studies. Finally, nurses also have an opportunity to explore independent interventions such as preoperative teaching, discharge follow-up, and home international normalized ratio monitoring to improve the HRQOL among those with AS.
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Health-related QOL was inadequately defined in most studies. While consistent use of broad, generic measures made for ease of comparison, these measures have not been validated in the AS population. Researchers who augmented generic HRQOL measures had important findings related to patient concerns of valve click and lifetime anticoagulation. Health-related QOL was found to be affected by valve noise and anticoagulation rather than the specific valve type when comparing patients receiving biological versus mechanical valves. Therefore, anticoagulation status needs to be evaluated as an independent variable in future studies. Selection for surgery should not be based on age alone. Early consideration should be given to the presence of symptoms prior to surgery because of evidence that patients with fewer symptoms preoperatively have better HRQOL after AVR.
Overall, the literature's strengths have been limited primarily by the fact that investigators have studied HRQOL only as an outcome of surgery. As a result, HRQOL outcomes cannot be transferred to AS patients at other stages of the disease continuum (presurgical or nonsurgical). Future studies to evaluate patients from disease diagnosis through symptom development and the varying treatment options would be necessary to gain a better perspective of HRQOL for patients with AS as a whole.
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