Understanding delays in chronic limb-threatening ischaemia care: Application of the theoretical domains framework to identify factors affecting primary care clinicians' referral behaviours.

INTRODUCTION: Patients in the community with suspected Chronic limb-threatening ischaemia (CLTI) should be urgently referred to vascular services for investigation and management. The Theoretical Domains Framework (TDF) allows identification of influences on health professional behaviour in order to inform future interventions. Here, the TDF is used to explore primary care clinicians' behaviours with regards to recognition and referral of CLTI. METHODS: Semi-structured interviews were conducted with 20 podiatrists, nurses and general practitioners in primary care. Directed content analysis was performed according to the framework method. Utterances were coded to TDF domains, and belief statements were defined by grouping similar utterances. Relevance of domains was confirmed according to belief frequency, presence of conflicting beliefs and the content of the beliefs indicating relevance. RESULTS: Nine TDF domains were identified as relevant to primary care clinicians: Knowledge, Environmental context and resources, Memory, Decision and attention processes, Beliefs about capabilities, Skills, Emotions, Reinforcement and Behavioural regulation. Relationships across domains were identified, including how primary care clinician confidence and working in a highly pressurized environment can affect behaviour. CONCLUSION: We have identified key barriers and enablers to timely recognition and referral behaviour. These beliefs identify targets for theory-driven behaviour change interventions to reduce delays in CLTI pathways.

A fluctuating intensity of care: A qualitative study on the experiences of informal caregivers of patients with critical limb-threatening ischemia.

Informal caregivers play a significant role in providing care for older, often vulnerable, patients, and supporting them as they live with chronic diseases. Due to the rising prevalence of older vascular patients and their use of healthcare, the role of their informal caregivers will become more important. However, little is known about the experiences of informal caregivers of patients with critical limb-threatening ischemia and the impact of informal care on different aspects of these caregivers' lives. In addition, literature does not describe the burden this role brings with it, or lack thereof. Therefore a qualitative study using a phenomenological approach, specifically interpretive phenomenological analysis, was used to gain insight into the experiences of the primary informal caregivers of patients with chronic limb-threatening ischemia. Data were collected via semi-structured interviews and focus groups discussions. Fifteen primary informal caregivers of patients with critical limb-threatening ischemia under the care of the vascular surgeon at a tertiary teaching hospital in the Netherlands were included. Data analysis yielded three themes: the perceived identity of this group of caregivers; the varying intensity of informal care; and the collaboration between informal carers, their care recipients and the professional care provider within the vascular surgery department. In contrast to carers of other chronic diseases, the shifting intensity of care that informal caregivers of critical limb-threatening ischemia patients experience seems to prevent long-term overload. Adapting to that fluctuating situation requires flexibility from healthcare providers within the vascular surgery department. In addition, professionals need to involve informal caregivers in the patient's decision-making process and recognize their role in that process.

A Comparison of Quality of Life in Elderly Patients with Intermittent Claudication and Chronic Limb-Threatening Ischemia.

BACKGROUND: Intermittent claudication (IC) and chronic limb-threatening ischemia (CLTI) are both associated with a decreased health status and possibly quality of life (QOL). A better understanding of the differences in QOL between patients with IC and CLTI could be of additional value in shared decision-making. The aim of this study was to compare the QOL at baseline between patients with IC and patients with CLTI. METHODS: The study population was based on 2 study cohorts, 1 cohort consisted of patients with IC (ELECT registry) and the other cohort of patients with CLTI (KOP-study). Patients with an age of ≥70 years were included. QOL at baseline was measured by the WHOQOL-BREF questionnaire. Nonresponders were excluded from data analyses. Student's t-tests and analysis of covariance (ANCOVA) analyses were used to compare QOL between the 2 groups. Outcomes of the ANCOVA analyses were expressed as estimated marginal means. RESULTS: In total, 308 patients were included, 115 patients with IC and 193 patients with CLTI. Patients with CLTI were older (median age 80 years vs. 75 years, P < 0.001) and had more comorbidities. Patients with IC had a statistically significant higher QOL regarding physical health (mean 13.7 [standard deviation (SD) 2.3] vs. 10.8 [SD 2.8], P < 0.001), psychological health (mean 15.3 [SD 2.1] vs. 14.1 [SD 2.4], P < 0.001), environment (mean 16.3 [SD 2.4] vs. 15.5 [SD 2.0], P < 0.002), and the overall domain (mean 3.5 [SD 0.7] vs. 3.1 [SD 0.9], P < 0.001). After correcting for the confounding effect of age and sex, patients with IC still had a statistically significant higher QOL in the physical, psychological, environment, and overall domain. CONCLUSIONS: Patients with IC had a significantly higher QOL in the physical, psychological, environment, and overall domains of the WHOQOL-BREF questionnaire compared with patients with CLTI. This underlines the importance of strategies that reduce disease progression as disease progression is associated with a decrease in QOL.

Descriptive title: The body with chronic limb-threatening ischaemia: A phenomenologically derived understanding.

AIMS AND OBJECTIVES: To explore person and family lifeworld narratives of chronic limb-threatening ischaemia (CLTI) after major amputation has been offered as a treatment option. BACKGROUND: Chronic limb-threatening ischaemia manifests as ischaemic pain, ulceration and/or gangrene and is receiving heightened attention due to the increasing health system burden from associated complex wounds and hospitalisations for repeat procedures. The patient and family impact of these manifestations is not well-reported: current studies largely seek to measure treatment outcomes. Patient-reported outcome measurements need to be developed but should be underpinned by rigorous qualitative research. DESIGN: Prospective, longitudinal, qualitative design using interpretive phenomenology. METHODS: The journeys of 19 people with CLTI were explored via 42 semi-structured interviews with 14 patient and 13 family participants. The initial interview was conducted soon after the advice of the need for major amputation, and where amputation followed, participants were invited for a second interview 6 months postprocedure. Hermeneutic phenomenological analysis was guided by Merleau-Ponty's philosophy of embodiment. RESULTS: People with embodied CTLI faced an existential crisis due to the catastrophic impact of creeping decay of their flesh and vascular system, relentless pain and a sense of spreading poison from gangrene, infection and drugs, which disrupted the interleaving of the physical and existential body. Consequent to the creeping decay and surgery, participants also experienced shifting body boundaries and an unreliable body. CONCLUSIONS: The lifeworld of the patient and family living with CTLI is irrevocably altered through the disruption of a spontaneous and reliable body. This shapes subsequent therapeutic relationships and discourse. RELEVANCE TO CLINICAL PRACTICE: People facing CLTI require early patient- and family-centred discussions about the possibility for major amputation and its potential to arrest the further decline of the body and to support the body's existential expression.

Important differences between quality of life and health status in elderly patients suffering from critical limb ischemia.

INTRODUCTION: Critical limb ischemia (CLI) patients are often of advanced age with reduced health status (HS) and quality of life (QoL) at baseline. Physical health is considered as the most affected domain due to reduced mobility and ischemic pain. QoL and HS are often used interchangeably in the current literature. HS refers to objectively perceived physical, psychological, and social functioning and in assessing QoL, change is measured subjectively and can only be determined by the individual since it concerns patients' evaluation of their functioning. It is important to distinguish between QoL and HS, especially in the concept of shared decision-making when the opinion of the patient is key. Goal of this study was to examine and compare QoL and HS in elderly CLI patients in relation to the used therapy, with a special interest in conservatively treated patients. METHODS: Patients suffering from CLI and ≥70 years old were included in a prospective study with a follow-up period of 1 year. Patients were divided into three groups; endovascular revascularization, surgical revascularization, and conservative therapy. The WHOQoL-Bref was used to determine QoL, and the 12-Item Short Form Health Survey was used to evaluate HS at baseline, 5-7 days, 6 weeks, 6 months, and 1 year. RESULTS: Physical QoL of endovascularly and surgically treated patients showed immediate significant improvement during follow-up in contrast to delayed increased physical HS at 6 weeks and 6 months (P<0.001). Conservatively treated patients showed significantly improved physical QoL at 6 and 12 months (P=0.02) in contrast to no significant improvement in physical HS. CONCLUSION: This study demonstrates that QoL and HS are indeed not identical concepts and that differentiating between these two concepts could influence the choice of treatment in elderly CLI patients. Discriminating between QoL and HS is, therefore, of major importance for clinical practice, especially to achieve shared decision-making.

Is amputation in the elderly patient with critical limb ischemia acceptable in the long term?

PURPOSE: Despite high amputation rates, data on patient-reported outcomes is scarce in the elderly population with critical limb ischemia. The aim of this study was to provide mortality rates and long-term changes of the following patient-reported outcomes in elderly critical limb ischemia amputees: quality of life (QoL), health status (HS), and symptoms of depression. PATIENTS AND METHODS: In this prospective observational cohort study, amputated critical limb ischemia patients ≥70 years were included. The follow-up period was two years. Within the follow-up period patients completed the following questionnaires: the World Health Organization Quality Of Life -abbreviated version of the WHOQOL 100 (WHOQOL-BREF), the 12-Item Short Form Health Survey, and the Center for Epidemiological Studies Depression Scale. RESULTS: A total of 49 elderly patients with critical limb ischemia had undergone major limb amputation within two years after inclusion. In these patients, the one-year mortality rate was 39% and the two-year mortality rate was 55%. The physical QoL was the only domain of the WHOQOL-BREF that improved significantly across time after amputation (p≤0.001). In the long-term, there was no difference in the ability to enjoy life (p=0.380) or the satisfaction in performing daily living activities (p=0.231) compared to the scores of the general elderly population. After amputation, the physical HS domain (p≤0.001) and the mental HS domain (p=0.002) improved. In the first year, amputees experienced less symptoms of depression (p=0.004). CONCLUSION: Elderly critical limb ischemia amputees are a fragile population with high mortality rates. Their QoL and HS increased after major limb amputation as compared to the baseline situation and they experienced less symptoms of depression. Moreover, our results show that, in the long-term, major limb amputation in the elderly patients with critical limb ischemia shows an acceptable QoL, which, in some aspects, is comparable to the QoL of their peers. These results can improve the shared-decision making process that does not delay the timing of major limb amputation.

Locus coeruleus-CA1 projections are involved in chronic depressive stress-induced hippocampal vulnerability to transient global ischaemia.

Depression and transient ischaemic attack represent the common psychological and neurological diseases, respectively, and are tightly associated. However, studies of depression-affected ischaemic attack have been limited to epidemiological evidences, and the neural circuits underlying depression-modulated ischaemic injury remain unknown. Here, we find that chronic social defeat stress (CSDS) and chronic footshock stress (CFS) exacerbate CA1 neuron loss and spatial learning/memory impairment after a short transient global ischaemia (TGI) attack in mice. Whole-brain mapping of direct outputs of locus coeruleus (LC)-tyrosine hydroxylase (TH, Th:) positive neurons reveals that LC-CA1 projections are decreased in CSDS or CFS mice. Furthermore, using designer receptors exclusively activated by designer drugs (DREADDs)-based chemogenetic tools, we determine that Th:LC-CA1 circuit is necessary and sufficient for depression-induced aggravated outcomes of TGI. Collectively, we suggest that Th:LC-CA1 pathway plays a crucial role in depression-induced TGI vulnerability and offers a potential intervention for preventing depression-related transient ischaemic attack.

A Qualitative Study Exploring Patient Concerns and Values in Chronic Limb-Threatening Ischemia.

BACKGROUND: Chronic limb-threatening ischemia (CLTI) is the debilitating end stage of peripheral artery disease, causing patients to experience low quality of life and poor health outcomes. It is unknown which aspects of care patients with CLTI value. This pilot qualitative study aims to explore patients' concerns and values related to CLTI treatment, to better inform patient-centered care. METHODS: A qualitative study design was piloted to explore the experiences of patients with CLTI undergoing elective vascular surgery. In-depth, semistructured interviews were recorded preoperatively and 3 mo after discharge. Transcribed interviews were analyzed using content analysis, to derive patient-centered themes. Findings were mapped to a framework of patient-centered care. RESULTS: Twelve interviews from six participants were analyzed. Five themes related to participant experiences of CLTI were identified: treatment and diagnosis, concerns about symptoms, limitations in physical function, social function, and emotional function. Participants expressed how CLTI intruded on all aspects of their lives. Framework analysis demonstrated CLTI patients valued patient-centered care relating to both relational and functional aspects of care. In particular, participants valued supportive and trustworthy care, in addition to integrated, holistic care that recognized the patient in the context of their overall health and life. CONCLUSIONS: Feasibility was demonstrated for both study design and methodology. Data obtained from interviews were sufficiently "rich and thick" in quality and quantity to allow for common themes related to experience and health care values in patients with CLTI to be identified. If confirmed in future studies, these findings will enhance patient-centered care in CLTI.

Investigation of the effect of the virtual reality application on experimental pain severity in healthy.

OBJECTIVE: This study aimed to investigate the effect of virtual reality application on experimental ischemic pain created with a blood pressure instrument in healthy volunteers. METHODS: The research sample consisted of 172 volunteer adult students who conformed to the inclusion criteria. These individuals were assigned into an experimental (n=86) and a control group (n=86) by a simple randomization method. All individuals in the experimental and control groups wereexperimentally subjected to pain for two minutes by applying 260 mmHg of pressure 3-4 cm above the antecubital region of the left arm with an aneroid adult-type blood pressure instrument. During the procedure, the volunteers in the experimental group watched virtual reality images, while those in the control group received no intervention. Immediately after the procedure, the pain levels of the individuals in both groups were assessed with a Visual Analog Scale (VAS). RESULTS: We found that the mean pain score of the individuals in the experimental group was 2.62±1.82, and that of individuals in the control group was 5.75±1.65. Results of the statistical analysis showed a statistically significant difference between the mean pain scores of the individuals in the experimental and control groups (p<0.001). CONCLUSION: This study found that the use of virtual reality was effective in reducing the level of pain in healthy individuals. This method used a smartphone with widespread availability and ease of transportation, which can be used by health professionals as a non-pharmacological method in the management of pain.

Quality of Life and not Health Status Improves After Major Amputation in the Elderly Critical Limb Ischaemia Patient.

OBJECTIVES: A patient-oriented appraisal of treatment has become extremely important, particularly in elderly patients with critical limb ischaemia (CLI). Quality of life (QoL) is an important patient-reported outcome in vascular surgery. Frequently, the physical domain of QoL questionnaires represents an 'objective' evaluation of performing activities, which is expected to be impaired after major limb amputation. However, an objective appraisal of physical function is an assessment of health status (HS) and not of QoL. Little is known about the subjective appraisal of physical health (QoL). The goal of this study was to evaluate, prospectively, QoL in relation to HS in elderly CLI patients undergoing major limb amputation. METHODS: Patients suffering from CLI aged 70 years or older were included in a prospective observational cohort study with a follow-up period of 1 year. Patients were divided according to having had an amputation or not. The World Health Organization Quality Of Life-BREF (WHOQOL-BREF) was used to asses QoL. The 12-Item Short Form Health Survey (SF-12) was used to measure HS. These self-reported questionnaires were completed five times during follow-up. RESULTS: Two-hundred patients were included of whom 46 underwent a major limb amputation within one year. Amputees had a statistically significant improvement of their physical QoL after six months (14.0 vs. 9.0 (95% CI -7.84;-1.45),p = 0.005) and after a one-year follow-up (14.0 vs. 9.0 (95% CI -9.58;-1.46),p = 0.008). They did not however show any statistically significant difference in HS. For non-amputees, both physical QoL and HS improved. An instant statistically significant improvement of the physical QoL appeared 1 week after inclusion (12.0 vs. 10.9 (95% CI -1.57;-0.63),p<0.001). Similarly, statistically significant improvement in the physical HS first occurred at 1 week follow-up (29.0 vs. 28.9 (95% CI -5.78; -2.23),p = 0.003). CONCLUSIONS: There is a clear difference between patients' functioning (HS) and the patients' appraisal of functioning (QoL). In elderly CLI patients, this study clearly suggests a discrepancy between the physical QoL (WHOQOL-BREF) and HS (SF-12) measurements in vascular amputees. This raises the question, which outcome measurement is the most relevant for elderly CLI patients. Individual treatment goals should be kept in mind when assessing the HS or QoL outcome of patients undergoing hospital care. With respect to shared decision making, distinctive and subjective QoL questionnaires, like the WHOQOL-BREF, provide a very important outcome measurement and should be used in future research.

Investigation of the effect of the virtual reality application on experimental pain severity in healthy

SUMMARY OBJECTIVE: This study aimed to investigate the effect of virtual reality application on experimental ischemic pain created with a blood pressure instrument in healthy volunteers. METHODS: The research sample consisted of 172 volunteer adult students who conformed to the inclusion criteria. These individuals were assigned into an experimental (n=86) and a control group (n=86) by a simple randomization method. All individuals in the experimental and control groups wereexperimentally subjected to pain for two minutes by applying 260 mmHg of pressure 3-4 cm above the antecubital region of the left arm with an aneroid adult-type blood pressure instrument. During the procedure, the volunteers in the experimental group watched virtual reality images, while those in the control group received no intervention. Immediately after the procedure, the pain levels of the individuals in both groups were assessed with a Visual Analog Scale (VAS). RESULTS: We found that the mean pain score of the individuals in the experimental group was 2.62±1.82, and that of individuals in the control group was 5.75±1.65. Results of the statistical analysis showed a statistically significant difference between the mean pain scores of the individuals in the experimental and control groups (p<0.001). CONCLUSION: This study found that the use of virtual reality was effective in reducing the level of pain in healthy individuals. This method used a smartphone with widespread availability and ease of transportation, which can be used by health professionals as a non-pharmacological method in the management of pain.

RESUMO OBJETIVO: El objetivo de este estudio fue investigar el efecto de la aplicación de realidad virtual en el dolor isquémico experimental creado con un instrumento de presión arterial en voluntarios sanos. MÉTODO: La muestra de investigación consistió en 172 estudiantes adultos voluntarios que cumplieron con los criterios de inclusión. A estos individuos se les asignó mediante un método de aleatorización simple en un grupo experimental (n = 86) y uno de control (n = 86). Todos los individuos en los grupos experimentales y de control fueron sometidos experimentalmente a dolor durante dos minutos aplicando 260 mmHg de presión 3-4 cm por encima de la región antecubital del brazo izquierdo con un instrumento de presión arterial aneroide tipo adulto. Durante el procedimiento, los voluntarios en el grupo experimental observaron imágenes de realidad virtual, mientras que los del grupo de control no recibieron ninguna intervención. Inmediatamente después del procedimiento, los niveles de dolor de los individuos en ambos grupos se evaluaron con una Escala Analógica Visual (EAV). RESULTADOS: Se encontró que el puntaje promedio de dolor de los individuos en el grupo experimental fue 2.62 ± 1.82, y el de los individuos en el grupo control fue de 5.75 ± 1.65. Los resultados del análisis estadístico mostraron una diferencia estadísticamente significativa entre las puntuaciones medias de dolor de los individuos en los grupos experimental y control (p<0,000). CONCLUSÃO: Se encontró en este estudio que el uso de la realidad virtual fue efectivo para reducir el nivel de dolor en individuos sanos. Este método, que se lleva a cabo mediante el uso del teléfono inteligente y que ofrece una amplia disponibilidad y facilidad de transporte, puede ser utilizado por profesionales de la salud como un método no farmacológico en el tratamiento del dolor.

Is There an Important Role for Anxiety and Depression in the Elderly Patients with Critical Limb Ischemia, Especially After Major Amputation?

BACKGROUND: In patients with critical limb ischemia, an association is assumed between depression and worse outcome for morbidity, such as major limb amputation. After major amputation, anxiety and depression are common. We aimed to determine the association of depressive and anxiety symptoms in the elderly with critical limb ischemia, especially after major limb amputation. METHODS: Patients with critical limb ischemia aged ≥70 years were included in this prospective observational cohort study between January 2012 and February 2016 in 2 Dutch hospitals. After a multidisciplinary vascular conference, patients were divided into 4 treatment groups: endovascular revascularization, surgical revascularization, conservative therapy, and primary major amputation. In a 1-year follow-up period, depression and anxiety were measured 4 times using the Dutch versions of the Center for Epidemiological Studies Depression Scale and the State-Trait Anxiety Inventory. RESULTS: One Hundred eighty-seven patients were included. Within 1 year, 44 patients underwent a major limb amputation. Lower amputation-free survival did not differ significantly for patients with versus without greater anxiety (X2 [1] = 0.689, P = 0.407) and also not for patients with versus without more depressive symptoms (X2 [1] = 0.614, P = 0.433). For both groups, there were no significant changes in anxiety scores over time. After a median follow-up time of 336.5 days and 365 days, depressive symptoms significantly decreased in amputees, respectively, 8.5 vs. 4.5 (95% CI 1.76-7.48, P = 0.002) and 8.5 vs. 4.3 (95% CI 0.61-9.82, P = 0.027) when compared to the baseline measurement. Similarly, nonamputees had significantly lower overall score for depressive symptoms after a median follow-up time of 365 days (10.1 vs. 4.1, 95% CI 4.49 to 6.90, P < 0.001). CONCLUSIONS: In the opinion of the medical health care provider, amputation is a severe and unwanted end phase of critical limb ischemia. However, depressive symptoms seem to decrease over time and anxiety symptoms do not seem to be affected in patients after major limb amputation. In addition, patients with greater trait anxiety or more depressive symptoms at baseline did not have significantly higher amputation rates. These findings are similar to the course of depressive and anxiety symptoms for the elderly patients without major limb amputation.

The chaos of hospitalisation for patients with critical limb ischaemia approaching major amputation.

AIMS AND OBJECTIVES: To illuminate the hospital experience for patients and families when major amputation has been advised for critical limb ischaemia (CLI). BACKGROUND: CLI creates significant burden to the health system and the family, particularly as the person with CLI approaches amputation. Major amputation is often offered as a late intervention for CLI in response to the marked deterioration of an ischaemic limb, and functional decline from reduced mobility, intractable pain, infection and/or toxaemia. While a wealth of clinical outcome data on CLI and amputation exists internationally, little is known about the patient/family-centred experience of hospitalisation to inform preservation of personhood and patient-centred care planning. DESIGN: Longitudinal qualitative study using Heideggerian phenomenology. METHODS: Fourteen patients and 13 family carers provided a semistructured interview after advice for major amputation. Where amputation followed, a second interview (6 months postprocedure) was provided by eight patients and seven family carers. Forty-two semistructured interviews were audio-recorded and transcribed verbatim. Hermeneutic phenomenological analysis followed. RESULTS: Hospitalisation for CLI, with or without amputation, created a sense of chaos, characterised by being fragile and needing more time for care (fragile body and fragile mind, nurse busyness and carer hypervigilance), being adrift within uncontrollable spaces (noise, unreliable space, precarious accommodation and unpredictable scheduling) and being confused by missed and mixed messages (multiple stakeholders, information overload and cultural/linguistic diversity). CONCLUSIONS: Patients and families need a range of strategies to assist mindful decision-making in preparation for amputation in what for them is a chaotic process occurring within a chaotic environment. Cognitive deficits increase the care complexity and burden of family advocacy. RELEVANCE TO CLINICAL PRACTICE: A coordinated, interprofessional response should improve systems for communication, family engagement, operation scheduling and discharge planning to support preparation, adjustment and allow a sense of safety to develop. Formal peer support for patients and caregivers should be actively facilitated.

Quality of Life and Mortality after Endovascular, Surgical, or Conservative Treatment of Elderly Patients Suffering from Critical Limb Ischemia.

BACKGROUND: Revascularization to relieve ischemic pain and prevent limb loss is the cornerstone of critical limb ischemia (CLI) treatment; however, not all elderly patients are deemed fit for revascularization. Patient-related outcome measurements are important in these patients. Quality of life (QoL) results regarding the effect of endovascular, surgical, and conservative treatment on the QoL in the elderly are scarce in the current literature. The goal of this study was to explore the outcomes of the different treatment modalities in elderly patients suffering from CLI, with a specific focus on QoL. METHODS: A total of 195 CLI patients ≥70 years were prospectively included between January 2012 and February 2016 and divided into 6 groups (endovascular revascularization, surgical revascularization, and conservative treatment). Two age groups (70-79 and >80 years) were analyzed. Follow-up was performed at 5-7 days, 6 weeks, and 6 months. World Health Organization Quality of Life-BREF questionnaire was used to determine QoL. The Vascular-Physiological and Operative Severity Score for Enumeration of Mortality and Morbidity score was noted. QoL was used as the primary end point, with mortality and limb salvage as the secondary end points. RESULTS: Six-month mortality was significantly lower in surgically treated patients aged 70-79 years (4%) as compared with endovascular (24%, P = 0.001) or conservative treatment (25%, P = 0.02). There was no significant difference in 6-month mortality in patients >80 years among endovascularly (38%), surgically (15%), and conservatively treated patients (27%). QoL significantly increased at all follow-up moments in surgically treated patients between 70 and 79 years and at 6 months in endovascularly treated patients. Conservatively treated patients did not improve their QoL in this age group. All patients aged >80 years, including conservatively treated patients, showed significantly improved QoL results at 6 months. CONCLUSIONS: Elderly patients judged fit for surgery may benefit the most from surgical revascularization, reporting low mortality rates, low adverse events and significantly gained QoL in multiple domains. However, all 3 treatment modalities have significantly increased physical health at 6 months. Conservative therapy seems to be an acceptable treatment option in patients unfit for revascularization with gained physical health at 6 months.

Assessment of Minimum Important Difference and Substantial Clinical Benefit with the Vascular Quality of Life Questionnaire-6 when Evaluating Revascularisation Procedures in Peripheral Arterial Disease.

OBJECTIVES: Patient reported outcomes are increasingly used to assess outcomes after peripheral arterial disease (PAD) interventions. VascuQoL-6 (VQ-6) is a PAD specific health-related quality of life (HRQoL) instrument for routine clinical practice and clinical research. This study assessed the minimum important difference for the VQ-6 and determined thresholds for the minimum important difference and substantial clinical benefit following PAD revascularisation. MATERIALS AND METHODS: This was a population-based observational cohort study. VQ-6 data from the Swedvasc Registry (January 2014 to September 2016) was analysed for revascularised PAD patients. The minimum important difference was determined using a combination of a distribution based and an anchor-based method, while receiver operating characteristic curve analysis (ROC) was used to determine optimal thresholds for a substantial clinical benefit following revascularisation. RESULTS: A total of 3194 revascularised PAD patients with complete VQ-6 baseline recordings (intermittent claudication (IC) n = 1622 and critical limb ischaemia (CLI) n = 1572) were studied, of which 2996 had complete VQ-6 recordings 30 days and 1092 a year after the vascular intervention. The minimum important difference 1 year after revascularisation for IC patients ranged from 1.7 to 2.2 scale steps, depending on the method of analysis. Among CLI patients, the minimum important difference after 1 year was 1.9 scale steps. ROC analyses demonstrated that the VQ-6 discriminative properties for a substantial clinical benefit was excellent for IC patients (area under curve (AUC) 0.87, sensitivity 0.81, specificity 0.76) and acceptable in CLI (AUC 0.736, sensitivity 0.63, specificity 0.72). An optimal VQ-6 threshold for a substantial clinical benefit was determined at 3.5 scale steps among IC patients and 4.5 in CLI patients. CONCLUSIONS: The suggested thresholds for minimum important difference and substantial clinical benefit could be used when evaluating VQ-6 outcomes following different interventions in PAD and in the design of clinical trials.

Lifelong limb preservation: A patient-centered description of lower extremity arterial reconstruction outcomes.

BACKGROUND: Life expectancy is short for patients with critical limb ischemia (CLI), many of whom may fear amputation more than death. In light of the reduced life expectancy of these patients, the traditional 5-year freedom from amputation (FFA) statistic may not accurately address their concern. We developed a more relevant patient-centered calculation of major amputation risk during a patient's remaining lifetime to better answer the question, Will I ever lose my leg? METHODS: We identified all limbs undergoing first-time intervention for CLI in a large institutional database from 2005 to 2013. We calculated the traditional metrics of amputation-free survival (AFS, for which failure is death or amputation) and FFA (for which failure is amputation but deaths are censored and removed from further analysis). In addition, we propose a new term, lifelong limb preservation (LLP). LLP defines amputation as failure, but deaths are not censored and therefore reflect that LLP has been achieved. All deaths before 30 days were considered a failure in all three metrics, reflecting the risk of surgery. RESULTS: There were 1006 limbs identified as having first-time intervention for CLI (22% rest pain, 45% ulcer, 27% gangrene; 46% treated by angioplasty with or without stenting, 54% bypass). Using life-table analysis, 7-year AFS was 14% (561 events), FFA was 78% (123 events), and LLP was 86% (123 events). LLP was similar between patients undergoing angioplasty with or without stenting and bypass (7-year rates, 86% and 85%, respectively). For patients undergoing intervention for rest pain, 7-year rates were 14% for AFS, 84% for FFA, and 92% for LLP. For those undergoing treatment for ulcer, 7-year rates were 14% for AFS, 77% for FFA, and 86% for LLP. Finally, in those with gangrene, rates were 10% for AFS, 67% for FFA, and 79% for LLP. Using LLP, patients presenting with an ulcer can be told that although we cannot guarantee how long they will live, with revascularization there is approximately an 86% chance they will not lose the leg. CONCLUSIONS: These results show that the durability of our limb preservation efforts often exceeds the life expectancy of our patients. Using LLP as an outcomes assessment provides a more accurate and patient-centered answer to the question, If I have this procedure, will I ever lose my leg?

Cumulative Number of Treatment Interventions Predicts Health-Related Quality of Life in Patients with Critical Limb Ischemia.

BACKGROUND: Health-related quality of life (QOL) is usually assessed after a defined interval following a single intervention, but critical limb ischemia (CLI) is a chronic condition where multiple interventions are often required over a patient's lifetime. We hypothesized that the impact of CLI treatment interventions on QOL is diminished in the setting of multiple previous interventions. To test this hypothesis, we performed a cross-sectional study evaluating associations between cumulative number of previous peripheral artery disease (PAD) treatment interventions and QOL adjusting for both comorbidity and disease severity. METHODS: Participants with CLI (abnormal ankle brachial index [ABI] plus rest pain and/or tissue loss) were enrolled in a cross-sectional study and completed a disease-specific QOL assessment, (the Vascular Quality of Life Questionnaire-6 [VascuQol-6]). Minimum ABI was used to assess disease severity, and comorbidity was evaluated based on Charlson Comorbidity Index. Cumulative number of PAD treatment interventions was defined based on the lifelong total for both legs. QOL associations were evaluated using a multivariable linear regression model adjusted for age and gender. RESULTS: Thirty-two patients with CLI participated. Mean age was 63 ± 10 years, 72% were men, and 63% were white; mean ABI was 0.6 ± 0.2. Mean VQ-6 score was 11.6 ± 4.2, and QOL was lower in patients with more previous interventions. Multivariable models demonstrated that an increasing number of previous treatment interventions negatively impacted QOL (P = 0.047), whereas positive associations were identified for female gender (P = 0.006) and ABI (P = 0.006). No association between comorbidity and QOL was identified. CONCLUSIONS: Vascular-specific factors appear to be key determinants of QOL among patients with CLI, whereas comorbidity appears less important. Strategies focused on definitive and durable revascularization may reduce cumulative interventions and potentially maximize QOL for patients with CLI.

Clinimetric Evaluation of the Vascular Quality of Life Questionnaire in Patients with Lower Limb Ischaemia.

OBJECTIVES: Although commonly used to measure health related quality of life in patients with lower limb ischaemia, the measurement properties of the VascuQol and its assumed underlying health dimensions have not been studied in depth. The objective of this study was therefore to evaluate aspects of reliability and validity of the Dutch version of the VascuQol in patients with intermittent claudication (IC) and critical limb ischaemia (CLI). METHODS: Two datasets containing 195 patients with IC and 150 patients with CLI were used. Face validity of the VascuQol was examined in interviews with patients and a survey among health professionals. Homogeneity and structural validity of the VascuQol were assessed using Cronbach's α coefficients and explanatory factor analysis. Furthermore, convergent validity and known group validity were assessed. RESULTS: During the face validity interviews, three items were indicated as less relevant. Homogeneity analysis showed that the α coefficient of the VascuQol was .93, while the symptoms and social domains had α coefficients below the threshold of .70. The original five domains of the VascuQol could not be reproduced. Instead, factor analysis yielded a three factor solution. Moderate correlations were found for the activities, social and emotional VascuQol domains and matching health domains of other patient reported outcome measures (PROMs). Lower convergent correlations were observed for the pain domain and the sumscore of the VascuQol. The VascuQol was able to distinguish between patients' level of HRQL in relation to their disease severity (IC versus CLI patients). CONCLUSIONS: There is room for improvement of the VascuQol questionnaire. Further clinimetric studies should be performed to strengthen clinically relevant findings based on this instrument.

An integrative review of health-related quality of life in patients with critical limb ischaemia.

AIMS AND OBJECTIVES: To examine the domains and the domain-specific characteristics within a peripheral arterial disease health-related quality of life framework for their usefulness in defining critical limb ischaemia health-related quality of life. BACKGROUND: Critical Limb Ischaemia presents a highly individualised set of personal and health circumstances. Treatment options include conservative management, revascularisation or amputation. However, the links between treatment decisions and quality of life require further investigation. DESIGN: The framework for this integrative review was the peripheral arterial disease-specific health-related quality of life domains identified by Treat-Jacobson et al. RESULTS: The literature expanded and refined Treat-Jacobson's framework by modifying the characteristics to better describe health-related quality of life in critical limb ischaemia. CONCLUSIONS: Given that critical limb ischaemia is a highly individualised situation with powerful health-related quality of life implications, further research focusing on patient and family-centred decision-making relating to therapeutic options and advanced care planning is required. RELEVANCE TO CLINICAL PRACTICE: A critical limb ischaemia-specific, health-related quality of life tool is required to capture both the unique characteristics of this disorder, and the outcomes for active or conservative care among this complex group of patients.

[Psychological rehabilitation in patients with ischemic heart disease in the last 30 years].

Cardiological rehabilitation is one of the basic methods used in the treatment of cardiovascular diseases including ischemic heart disease. Complex cardiological rehabilitation consists of clinical assessment, pharmacotherapy, kinesitherapy, psychological rehabilitation, assessment of cardiovascular risk factors prevalence, lifestyle modification and health education of patients. The paper presents methods of psychological therapy applied at different stages of psychological rehabilitation in traditional clinical procedure in patients with ischemic heart disease. In the mid 90-ties of the 20th century new, invasive diagnostic and treatment methods of cardiovascular diseases were introduced. Along with application of modern methods of invasive treatment methods of psychological rehabilitation changed towards crisis intervention.