"What Is the Right Decision for Me?" Integrating Patient Perspectives Through Shared Decision-Making for Valvular Heart Disease Therapy.

Innovations in the treatment of valvular heart disease have transformed treatment options for people with valvular heart disease. In this rapidly evolving environment, the integration of patients' perspectives is essential to close the potential gap between what can be done and what patients want. Shared decision-making (SDM) and the measurement of patient-reported outcomes (PROs) are two strategies that are in keeping with this aim and gaining significant momentum in clinical practice, research, and health policy. SDM is a process that involves an individualised, intentional, and bidirectional exchange among patients, family, and health care providers that integrates patients' preferences, values, and priorities to reach a high-quality consensus treatment decision. SDM is widely endorsed by international valvular heart disease guidelines and increasingly integrated in health policy. Patient decision aids are evidence-based tools that facilitate SDM. The measurement of PROs-an umbrella term that refers to the standardised reporting of symptoms, health status, and other domains of health-related quality of life-provides unique data that come directly from patients to inform clinical practice and augment the reporting of quality of care. Sensitive and validated instruments are available to capture generic, dimensional, and disease-specific PROs in patients with valvular heart disease. The integration of PROs in clinical care presents significant opportunities to help guide treatment decision and monitor health status. The integration of patients' perspectives promotes the shift to patient-centred care and optimal outcomes, and contributes to transforming the way we care for patients with valvular heart disease.

The value of continuous nursing in patients after cardiac mechanical valve replacement.

OBJECTIVE: The purpose of this study was to explore the value of continuous nursing in patients after cardiac valve replacement. METHODS: The clinical data of 116 patients after cardiac mechanical valve replacement from January 2017 to January 2018 were analysed retrospectively. According to the nursing mode, the patients were divided into two groups: the continuous nursing group (group A, n = 56) and the conventional nursing group (group B, n = 60). RESULTS: The continuous nursing group exhibited significantly decreased SAS and SDS scores 1 year after surgery compared to the preoperative SAS and SDS scores(P < 0.05). The SAS and SDS scores of the continuous nursing group were significantly better than those of the traditional nursing group 1 year after surgery(P < 0.05). There were 4 patients with anticoagulant complications after discharge in the continuous nursing group, and 13 cases of anticoagulant complications in the conventional nursing group. There was a significant difference between the two groups. CONCLUSION: Continuous nursing improves patient compliance with treatment and reduces the occurrence of postoperative anticoagulation complications. The patient also receives proper psychological evaluations, which relieve patient anxiety and depression.

Symptoms, Hope, Self-Management Behaviors, and Quality of Life Among Chinese Preoperative Patient With Symptomatic Valvular Heart Diseases.

Introduction: More than 42 million people are estimated to suffer from valvular heart disease (VHD) worldwide with a prevalence of 5.3% to 7.7% in the Chinese adult population. The purpose of this study was to examine the associations between symptoms, hope, self-management behaviors, and quality of life (QOL) for preoperative patients with symptomatic VHD in a rural area of China. Method: This was a descriptive comparative study that took place in Nanning, China, between January 2015 and March 2016. The sample was 128 preoperative patients with symptomatic VHD. Data were collected using the Symptom Distress Questionnaire, Herth Hope Index, Self-Management Scale, and Minnesota Living with Heart Failure Questionnaire. Results: Data from 122 patients were included in the final analysis. Mean scores of hope, self-management, and QOL were 36.71, 55.27, and 55.56. Worse total scores of symptom severity (r = 0.57 to 0.69, p < .001) and self-management behaviors (r = -0.22 to -0.25, p < .05) were associated with poorer QOL. Fatigue, loss of appetite, and self-management behaviors explained 49.90% variance of QOL (p < .001). Discussion: Fatigue, loss of appetite, and self-management influenced QOL of patients with symptomatic VHD. Interventions aimed at strengthening self-management and relieving symptoms should be tailored for patients with symptomatic VHD base on their traditional animist belief and food culture in rural areas of China such as the Zhuang Autonomous Region.

Screening for symptoms of depression and anxiety in a cardiology department. / Screening for symptomer på depresjon og angst ved en hjertemedisinsk avdeling.

BACKGROUND: Depression and anxiety are common in patients with cardiac disease and predict a poorer prognosis, increased mortality and reduced compliance with treatment. National and international guidelines recommend procedures for screening, but there is a lack of studies of such practices in Norwegian hospitals. The objective of this study was to implement a simple screening method for symptoms of depression and anxiety in patients with cardiac disease. MATERIAL AND METHOD: Patients in the Department of Cardiology at Diakonhjemmet Hospital who had valvular heart disease, tachyarrhythmia, myocardial infarction or heart failure were screened for symptoms of depression, anxiety and panic attacks with the aid of five questions from the Patient Health Questionnaire-2 (PHQ-2), Generalized Anxiety Disorder Scale-2 (GAD-2) and Patient Health Questionnaire - Somatic, Anxiety, and Depressive Symptom Scales (PHQ-SADS). The patients were recruited from the outpatient clinic or ward at least one month after acute heart disease. RESULTS: A total of 57 of 232 patients reported symptoms of depression or anxiety when screened. The screening method was easy to implement, but time constraints and uncertainty regarding procedures for follow-up and the effect of following up the patients were reported. INTERPRETATION: Good tools and methods are available for screening for symptoms of depression and anxiety and anxiety in patients with cardiac disease. More studies are needed regarding the benefits of screening, at what stage of the disease it should be performed, and whether it should be performed by the primary and/or the specialist health services.

Anxiety and Depression in Patients Undergoing Mitral Valve Surgery: A Prospective Clinical Study.

BACKGROUND: Impending cardiac surgery presents an existential experience that may induce psychological trauma. Moreover, quality of life long after successful coronary artery bypass graft surgery (CABG) can be impaired. AIM: The aim of this study was to describe the time course of anxiety and depression in patients undergoing mitral valve surgery and compare it with our earlier results of patients undergoing CABG, a disease that is likely to be related to psychosomatic disorders. We hypothesized that patients undergoing mitral valve surgery can better manage stresses of cardiac surgery than patients undergoing CABG. PATIENTS AND METHODS: Of 117 patients undergoing mitral valve surgery, 100 patients (22 to 87 years; 53 females) completed the study and were interviewed before (pre), 1 week after (early), and 6 months after (late) surgery. The Hospital Anxiety and Depression Scale (HADS) was employed. RESULTS: The proportion of patients with elevated anxiety scores (AS ≥ 8) was higher than normal (19.8%): pre, 33.0%; early, 28.0%; and was normalized late (18.0%). Similarly, depression scores (DS ≥ 8) were increased: pre, 15.0%; early, 20.0%; and late 14.0%, respectively (normal: 3.2%). CONCLUSION: Coronary heart disease of CABG patients is presented as a systemic disorder, associated with both higher and postoperatively increased distress levels than in mitral valve patients. Anxiety and depression should be recognized as possible symptoms of psychosomatic disorders necessitating psychotherapeutic intervention to prevent postoperative depression and warrant patient-perceived surgical outcome that is additionally affected by expectations with respect to treatment and individual coping capacities. HADS is recommended to screen for vulnerable patients in the clinical routine, and psychosomatic support should be provided.

Patient perceptions of experience with cardiac rehabilitation after isolated heart valve surgery.

BACKGROUND: Little evidence exists on whether cardiac rehabilitation is effective for patients after heart valve surgery. Yet, accepted recommendations for patients with ischaemic heart disease continue to support it. To date, no studies have determined what heart valve surgery patients prefer in a cardiac rehabilitation programme, and none have analysed their experiences with it. AIMS: The purpose of this qualitative analysis was to gain insight into patients' experiences in cardiac rehabilitation, the CopenHeartVR trial. This trial specifically assesses patients undergoing isolated heart valve surgery. METHODS: Semi-structured interviews were conducted with nine patients recruited from the intervention arm of the trial. The intervention consisted of a physical training programme and a psycho-educational intervention. Participants were interviewed three times: 2-3 weeks, 3-4 months and 8-9 months after surgery between April 2013 and October 2014. Data were analysed using qualitative thematic analysis. RESULTS: Participants had diverse needs and preferences. Two overall themes emerged: cardiac rehabilitation played an important role in (i) reducing insecurity and (ii) helping participants to take active personal responsibility for their health. Despite these benefits, participants experienced existential and psychological challenges and musculoskeletal problems. Participants also sought additional advice from healthcare professionals both inside and outside the healthcare system. CONCLUSIONS: Even though the cardiac rehabilitation programme reduced insecurity and helped participants take active personal responsibility for their health, they experienced existential, psychological and physical challenges during recovery. The cardiac rehabilitation programme had several limitations, having implications for designing future programmes.

Quality of Life and Anxiety in Younger Patients after Biological versus Mechanical Aortic Valve Replacement.

Background Since biological valve recipients are likely to need a redo procedure in the future for valve deterioration, we hypothesized patients might be more fearful about the progression of their disease than patients after aortic valve replacement (AVR) with a mechanical valve. The aim of this study is to compare the quality of life (QOL) and anxiety in patients who have undergone biological versus mechanical AVR. Method A total of 56 patients after mechanical AVR (mean age: 64.4 ± 8.17 years) and 66 patients after biological AVR (mean age: 64.8 ± 11.05 years) received three questionnaires 5.66 (± 2.68) years after surgery, including: The short form-36 (SF-36) to assess QOL, the fear of progression questionnaire (FOP), and the cardiac anxiety questionnaire (CAQ) to assess general anxiety, anxiety related to cardiac symptoms, and anxiety about progression of heart disease and valve and anticoagulation-specific questions. Results No significant differences were found for all categories of the SF-36. The FOP showed significantly favorable values for the biological AVR group. The CAQ showed a tendency in the subscale "avoidance" (i.e., avoidance of pulse increase) and "attention" towards more favorable values for the biological AVR group. Conclusions In contrast to our hypothesis, patients after mechanical AVR show significantly higher anxiety values for the FOP, and a tendency toward higher values for "avoidance" (i.e., avoidance of pulse increase). Partnership concerns, especially in terms of sexuality can be explained by factors that are recognizable for the partner, such as valve sound. These data provide evidence that factors that are continuously present after mechanical AVR, such as valve sound or anticoagulation might affect wellbeing stronger than the certainty of reoperation in the future after biological AVR. We conclude that implantation of a biological prosthesis can be justified in younger patients with regards to QOL.

Physical and mental recovery after conventional aortic valve surgery.

OBJECTIVE: Physical and mental recovery are important factors to consider in the treatment of aortic valve disease, and the process of recovery is not well known. We investigated the course of physical and mental recovery directly after conventional aortic valve surgery. METHODS: In a longitudinal study, 60 patients undergoing elective aortic valve surgery were studied preoperatively and at intervals of 4 weeks after aortic valve surgery. The last measurement was taken 6 months postoperatively. Measurements included the 6-minute walk test and N-terminal pro-B-type natriuretic peptide. Mental recovery was assessed by the Short Form Health Survey and the Hospital Anxiety and Depression Scale. All parameters were compared with published healthy norms. RESULTS: All parameters except for the anxiety score showed a significant decline after the first postoperative measurement at 1 week after aortic valve surgery. The baseline level was restored at 1 to 3 weeks (anxiety, depression, mental quality of life, Borg scale), 4 to 6 weeks (6-minute walk test, physical quality of life), and 9 weeks (N-terminal pro-B-type natriuretic peptide) after the first postoperative week. Significantly better values than preoperatively for the first time were reached at 2 to 3 weeks (anxiety, depression, mental quality of life), 5 weeks (6-minute walk test), 8 weeks (physical quality of life), and 12 weeks (N-terminal pro-B-type natriuretic peptide) after the first postoperative week. At 3 months postoperatively, significant improvements (P < .001) were seen in walk distance (+212 m), dyspnea (-1.11), physical (+12.38) and mental quality of life (+7.71), anxiety (-3.74), and depression (-3.62) compared with the first week postoperatively. At 6 months postoperatively, all parameters were significantly improved compared with preoperative data and, except for the N-terminal pro-B-type natriuretic peptide value, significantly better or equal compared with published healthy norms. CONCLUSIONS: After conventional aortic valve surgery, the most pronounced recovery was seen in the first 6 weeks postoperatively. Physical quality of life and N-terminal pro-B-type natriuretic peptide required a prolonged time for a complete recovery.

Cardiac rehabilitation increases physical capacity but not mental health after heart valve surgery: a randomised clinical trial.

OBJECTIVE: The evidence for cardiac rehabilitation after valve surgery remains sparse. Current recommendations are therefore based on patients with ischaemic heart disease. The aim of this randomised clinical trial was to assess the effects of cardiac rehabilitation versus usual care after heart valve surgery. METHODS: The trial was an investigator-initiated, randomised superiority trial (The CopenHeartVR trial, VR; valve replacement or repair). We randomised 147 patients after heart valve surgery 1:1 to 12 weeks of cardiac rehabilitation consisting of physical exercise and monthly psycho-educational consultations (intervention) versus usual care without structured physical exercise or psycho-educational consultations (control). Primary outcome was physical capacity measured by VO2 peak and secondary outcome was self-reported mental health measured by Short Form-36. RESULTS: 76% were men, mean age 62 years, with aortic (62%), mitral (36%) or tricuspid/pulmonary valve surgery (2%). Cardiac rehabilitation compared with control had a beneficial effect on VO2 peak at 4 months (24.8 mL/kg/min vs 22.5 mL/kg/min, p=0.045) but did not affect Short Form-36 Mental Component Scale at 6 months (53.7 vs 55.2 points, p=0.40) or the exploratory physical and mental outcomes. Cardiac rehabilitation increased the occurrence of self-reported non-serious adverse events (11/72 vs 3/75, p=0.02). CONCLUSIONS: Cardiac rehabilitation after heart valve surgery significantly improves VO2 peak at 4 months but has no effect on mental health and other measures of exercise capacity and self-reported outcomes. Further research is needed to justify cardiac rehabilitation in this patient group. TRIAL REGISTRATION NUMBER: NCT01558765, Results.

[Quality of life or life expectancy? Criteria and sources of information in the decision-making of patients undergoing aortic valve surgery]. / Lebensqualität oder Lebenserwartung? Kriterien und Informationsquellen für die Entscheidungsfindung bei Patienten im Vorfeld von Aortenklappenoperationen.

OBJECTIVES: Physicians are expected to involve patients adequately in the decision-making process prior to surgery. To this end, it is essential to have knowledge about the potential reasons for such a decision. In this study we investigated which information sources and decision criteria are important to patients prior to aortic valve surgery. METHODS: A consecutive sample of 468 patients (70.1%m, aged 66.9±14.2 years) was examined 2 years after aortic valve replacement or reconstruction with a self-developed questionnaire. RESULTS: Preoperative discussion with a cardiologist or a cardiac surgeon was the information source patients used most frequently and felt to be the most helpful. The most important decision criterion was quality of life, followed by life expectancy and likelihood of reoperation. Two years postoperatively, 97.3% of the patients were satisfied with their decision. CONCLUSIONS: Preoperative counseling by a physician plays an essential role in the decision-making process prior to cardiac surgery. Patients want to be involved in decision-making, though they do not want to bear the full responsibility.

Update to the study protocol, including statistical analysis plan for a randomized clinical trial comparing comprehensive cardiac rehabilitation after heart valve surgery with control: the CopenHeartVR trial.

BACKGROUND: Heart valve diseases are common with an estimated prevalence of 2.5% in the Western world. The number is rising because of an ageing population. Once symptomatic, heart valve diseases are potentially lethal, and heavily influence daily living and quality of life. Surgical treatment, either valve replacement or repair, remains the treatment of choice. However, post-surgery, the transition to daily living may become a physical, mental and social challenge. We hypothesize that a comprehensive cardiac rehabilitation program can improve physical capacity and self-assessed mental health and reduce hospitalization and healthcare costs after heart valve surgery. METHODS: This randomized clinical trial, CopenHeartVR, aims to investigate whether cardiac rehabilitation in addition to usual care is superior to treatment as usual after heart valve surgery. The trial will randomly allocate 210 patients 1:1 to an intervention or a control group, using central randomization, and blinded outcome assessment and statistical analyses. The intervention consists of 12 weeks of physical exercise and a psycho-educational intervention comprising five consultations. The primary outcome is peak oxygen uptake (VO2 peak) measured by cardiopulmonary exercise testing with ventilatory gas analysis. The secondary outcome is self-assessed mental health measured by the standardized questionnaire Short Form-36. Long-term healthcare utilization and mortality as well as biochemistry, echocardiography and cost-benefit will be assessed. A mixed-method design will be used to evaluate qualitative and quantitative findings, encompassing a survey-based study before the trial and a qualitative pre- and post-intervention study. CONCLUSION: This randomized clinical trial will contribute with evidence of whether cardiac rehabilitation should be provided after heart valve surgery. The study is approved by the local regional Research Ethics Committee (H-1-2011-157), and the Danish Data Protection Agency (j.nr. 2007-58-0015). TRIAL REGISTRATION: Trial registered 16 March 2012; ClinicalTrials.gov ( NCT01558765 ).

[Informed consent in valvular diseases].

Informed consent has two aspects. First, we must give patients sufficient, precise information on the nature of their disease, natural history, possible choices of treatment, and risks of the treatment to help them make their own decisions. The estimated risks should be based on a database, not on personal impressions or limited experience. In choosing the type of prosthetic valve in young or middle-aged patients, unbiased information based on guidelines should be presented. The second aspect of informed consent is its role as a contract for providing medical service. Estimated in-hospital mortality and major morbidities should be clarified in percentages on the consent form as confirmation of understanding.

Effect of comprehensive cardiac rehabilitation after heart valve surgery (CopenHeartVR): study protocol for a randomised clinical trial.

BACKGROUND: Heart valve diseases are common with an estimated prevalence of 2.5% in the Western world. The number is rising due to an ageing population. Once symptomatic, heart valve diseases are potentially lethal, and heavily influence daily living and quality of life. Surgical treatment, either valve replacement or repair, remains the treatment of choice. However, post surgery, the transition to daily living may become a physical, mental and social challenge. We hypothesise that a comprehensive cardiac rehabilitation programme can improve physical capacity and self-assessed mental health and reduce hospitalisation and healthcare costs after heart valve surgery. METHODS: A randomised clinical trial, CopenHeartVR, aims to investigate whether cardiac rehabilitation in addition to usual care is superior to treatment as usual after heart valve surgery. The trial will randomly allocate 210 patients, 1:1 intervention to control group, using central randomisation, and blinded outcome assessment and statistical analyses. The intervention consists of 12 weeks of physical exercise, and a psycho-educational intervention comprising five consultations. Primary outcome is peak oxygen uptake (VO2 peak) measured by cardiopulmonary exercise testing with ventilatory gas analysis. Secondary outcome is self-assessed mental health measured by the standardised questionnaire Short Form 36. Also, long-term healthcare utilisation and mortality as well as biochemistry, echocardiography and cost-benefit will be assessed. A mixed-method design is used to evaluate qualitative and quantitative findings encompassing a survey-based study before the trial and a qualitative pre- and post-intervention study. DISCUSSION: The study is approved by the local regional Research Ethics Committee (H-1-2011-157), and the Danish Data Protection Agency (j.nr. 2007-58-0015). TRIAL REGISTRATION: ClinicalTrials.gov (http://NCT01558765).

Improvement of physical and mental health after transfemoral transcatheter aortic valve implantation.

AIMS: Transcatheter aortic valve implantation (TAVI) has emerged as a treatment alternative to surgical aortic valve replacement in elderly high-risk patients with symptomatic severe aortic stenosis. In this patient population, rapid improvement or restoration of quality of life (QoL) is at least as important as improved clinical outcomes. The purpose of the present study was to assess changes in QoL in response to TAVI. METHODS AND RESULTS: Between August 2007 and August 2010, 62 patients (39% females, age 83 ± 5 years) underwent TAVI and were included in this QoL study. QoL was impaired at baseline and improved in all components of physical and mental health at nine months of follow-up: physical functioning (37.0 to 59.0, p<0.0001), physical role functioning (18.3 to 49.1, p<0.0001), general health (55.9 to 64.9, p=0.001), vitality (40.7 to 51.3, p<0.001), social functioning (67.4 to 76.8, p=0.049), emotional functioning (52.0 to 75.8, p<0.001) and mental health (66.6 to 75.8, p=0.05). The subscale bodily pain (60.7 to 70.4, p=0.058) showed a strong trend to improvement, but failed to reach statistical significance. Besides changes in health-related QoL, TAVI significantly improved symptoms (NYHA class 2.6 ± 0.8 to 1.4 ± 0.6, p<0.0001). CONCLUSIONS: TAVI leads to rapid and sustained restoration of all aspects of mental and physical health and effectively alleviates symptoms.

Anxiety, depression, and self-management: a systematic review.

The purpose of this article was to address the clinically relevant question: In the presence of anxiety and/or depression, do patients who have had heart surgery engage in self-management behaviors following hospital discharge? A systematic review of 16 studies that examined the psychological condition of patients who had coronary artery bypass graft (CABG) and/or valvular replacement surgery was conducted. Moderate to severe levels of anxiety and depression exist during the first month of home recovery and appear to have an effect on performance of self-management behaviors. As the influence of patients' psychological condition is continued to be examined, it is imperative for health care providers to manage increased rates of anxiety and/or depression following heart surgery. Music and relaxation therapy are presented as evidenced based recommendations for managing anxiety and depression in patients following heart surgery.

The impact of coronary artery disease on the quality of life of patients undergoing aortic valve replacement.

Of 415 patients, 200 undergoing aortic valve replacement (AVR) and 215 undergoing AVR in combination with myocardial revascularization [coronary artery bypass grafting (CABG)], had complete preoperative health-related quality of life (HRQOL) data. From this group, 224 patients had a follow-up of one year. To assess HRQOL, the EuroQol instrument was used. The EQ-5D index score was calculated, based on separate scores from five health domains, to express the global health status of the patient. The EQ visual analogue scale (VAS) was used to describe patients' subjective HRQOL. At baseline, the EQ-5D showed no significant differences between the two groups. The EQ-VAS score, however, was statistically significantly lower in the AVR+CABG patients (P=0.031). At one year postoperatively, both groups showed a statistically significant increase in the EQ-VAS (P=0.001 and P=0.001, respectively) and the EQ-5D (P=0.001 and P=0.001, respectively). This increase, however, could only be ascertained for the domain 'pain/discomfort' (P=0.001) in the AVR group, and for 'mobility' (P=0.018), 'usual activities' (P=0.001), 'pain/discomfort' (P=0.001) and 'anxiety/depression' (P=0.001) in the AVR+CABG group. At baseline, coronary artery disease had a negative influence on the patients' HRQOL, especially on the EQ-VAS. Postoperatively, all patients experienced significantly better HRQOL. However, the patients undergoing combined surgery experienced more benefit from their operation.

Survival and quality of life after aortic root replacement with homografts in acute endocarditis.

BACKGROUND: Treatment of prosthetic aortic valve endocarditis and native aortic valve endocarditis with abscess formation is associated with high mortality and morbidity. Aortic root replacement with a freestanding aortic homograft is an attractive alternative. We report outcome and quality of life after homograft replacement for infective endocarditis. METHODS: Sixty-two patients with infective prosthetic valve endocarditis (n = 31) or native valve endocarditis with abscess (n = 31), operated with homograft replacement were included. Thirty-day mortality, severe operative complications (dialysis, stroke, pacemaker implantation, myocardial infarction, and prolonged mechanical ventilation), midterm survival, reoperations, and quality of life were assessed after a mean follow-up of 37 ± 11 months. RESULTS: Nine patients (15%) died within 30 days and 22 patients (35%) had severe perioperative complications. Preoperative and perioperative variables univariately associated with early mortality were higher (Cleveland Clinic risk score [p = 0.014], extracorporeal circulation time [p = 0.003], prolonged inotropic support [p = 0.03], reoperation for bleeding [p = 0.01], and perioperative myocardial infarction [p < 0.001].) Cumulative survival was 82%, 78%, 75%, and 67% at one, three, five, and ten years, respectively. One patient was reoperated due to recurrence of endocarditis nine months after surgery and one after five years due to homograft failure. Quality of life, as assessed by the 36 item short-form health survey scales for physical and mental health, was not significantly different to an age-matched and gender-matched healthy control group. CONCLUSIONS: Severe acute aortic endocarditis treated with homograft replacement is still associated with a substantial early complication rate and mortality. Long-term survival and quality of life are satisfactory in patients surviving the immediate postoperative period.