Multicomponent Prehabilitation as a Novel Strategy for Preventing Delirium in Older Chronic Limb Threatening Ischemia Patients: A Study Protocol.

Objective: Chronic limb threatening ischemia is the final stage of peripheral arterial disease. Current treatment is based on revascularization to preserve the leg. In the older, hospitalized chronic limb threatening ischemia patient, delirium is a frequent and severe complication after revascularization. Delirium leads to an increased length of hospital stay, a higher mortality rate and a decrease in quality of life. Currently, no specific guidelines to prevent delirium in chronic limb threatening ischemia patients exist. We aim to evaluate the effect of a multicomponent, multidisciplinary prehabilitation program on the incidence of delirium in chronic limb threatening ischemia patients ≥65 years. Design: A prospective observational cohort study to investigate the effects of the program on the incidence of delirium will be performed in a large teaching hospital in the Netherlands. This manuscript describes the design of the study and the content of this specific prehabilitation program. Methods: Chronic limb threatening ischemia patients ≥65 years that require revascularization will participate in the program. This program focuses on optimizing the patient's overall health and includes delirium risk assessment, nutritional optimization, home-based physical therapy, iron infusion in case of anaemia and a comprehensive geriatric assessment in case of frailty. The primary outcome is the incidence of delirium. Secondary outcomes include quality of life, amputation-free survival, length of hospital stay and mortality. Exclusion criteria are the requirement of acute treatment or patients who are mentally incompetent to understand the procedures of the study or to complete questionnaires. A historical cohort from the same hospital is used as a control group. Discussion: This study will clarify the effect of a prehabilitation program on delirium incidence in chronic limb threatening ischemia patients. New insights will be obtained on optimizing a patient's preoperative mental and physical condition to prevent postoperative complications, including delirium. Trial: This protocol is registered at the Netherlands National Trial Register (NTR) number: NL9380.

Long-term Follow-up of a Randomized Clinical Trial Comparing Endovascular Revascularization Plus Supervised Exercise With Supervised Exercise Only for Intermittent Claudication.

OBJECTIVE: The goal of this study was to assess the long-term effectiveness of combination therapy for intermittent claudication, compared with supervised exercise only. BACKGROUND: Supervised exercise therapy is recommended as first-line treatment for intermittent claudication by recent guidelines. Combining endovascular revascularization plus supervised exercise shows promising results; however, there is a lack of long-term follow-up. METHODS: The ERASE study is a multicenter randomized clinical trial, including patients between May 2010 and February 2013 with intermittent claudication. Interventions were combination of endovascular revascularization plus supervised exercise (n = 106) or supervised exercise only (n = 106). Primary endpoint was the difference in maximum walking distance at long-term follow-up. Secondary endpoints included differences in pain-free walking distance, ankle-brachial index, quality of life, progression to critical limb ischemia, and revascularization procedures during follow-up. This randomized trial report is based on a post hoc analysis of extended follow-up beyond that of the initial trial. Patients were followed up until 31 July 2017. Data were analyzed according to the intention-to-treat principle. RESULTS: Median long-term follow-up was 5.4 years (IQR 4.9-5.7). Treadmill test was completed for 128/212 (60%) patients. Whereas the difference in maximum walking distance significantly favored combination therapy at 1-year follow-up, the difference at 5-year follow-up was no longer significant (53 m; 99% CI-225 to 331; P = 0.62). No difference in pain-free walking distance, ankle-brachial index, and quality of life was found during long-term follow-up. We found that supervised exercise was associated with an increased hazard of a revascularization procedure during follow-up (HR 2.50; 99% CI 1.27-4.90; P < 0.001). The total number of revascularization procedures (including randomized treatment) was lower in the exercise only group compared to that in the combination therapy group (65 vs 149). CONCLUSIONS: Long-term follow up after combination therapy versus supervised exercise only, demonstrated no significant difference in walking distance or quality of life between the treatment groups. Combination therapy resulted in a lower number of revascularization procedures during follow-up but a higher total number of revascularizations including the randomized treatment. TRIAL REGISTRATION: Netherlands Trial Registry Identifier: NTR2249.

Endovascular Revascularization Plus Supervised Exercise Versus Supervised Exercise Only for Intermittent Claudication: A Cost-Effectiveness Analysis.

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The effects of elective aortic repair, colorectal cancer surgery and subsequent postoperative delirium on long-term quality of life, cognitive functioning and depressive symptoms in older patients.

Objectives: This study aimed to demonstrate the impact of elective major abdominal surgery and subsequent postoperative delirium on quality of life (QOL; primary outcome), cognitive functioning and depressive symptoms (secondary outcomes) in older surgical patients.Method: A single-centre, longitudinal prospective cohort study was conducted between November 2015 and June 2018, including patients ≥70 years old who underwent surgery for colorectal cancer or an abdominal aortic aneurysm. They were followed-up at discharge and at 6 and 12 months postoperatively until June 2019. QOL was assessed with the World Health Organization Quality of Life-BREF questionnaire (WHOQOL-BREF). Cognitive functioning was measured with the Mini-Mental State Examination and depressive symptoms with the CES-D 16.Results: In all patients (n = 265), physical and psychological health were significantly lower at discharge compared to baseline (p < 0.001 for both domains). Physical health restored after 6 months, but psychological health remained decreased for the complete study period. Psychological, social and environmental QOL were significantly worse in patients with delirium compared to patients without (p = 0.001, p = 0.006 and p = 0.001 respectively). The cognitive functioning score was significantly lower at baseline in patients with delirium compared to those without (p = 0.006). Patients with delirium had a significantly higher CES-D 16 score compared to those without after 12 months (p = 0.027).Conclusion: Physical and psychological QOL were decreased in the early postoperative period. While physical health was restored after 6 and 12 months, psychological health remained decreased. After 12 months, postoperative delirium resulted in worse psychological, social and environmental QOL and more depressive symptoms. Decreased cognitive functioning may be a risk factor for delirium.

Intravenous Iron in a Prehabilitation Program for Older Surgical Patients: Prospective Cohort Study.

BACKGROUND: Older patients often have iron deficiency anemia before surgery, which can be effectively treated with intravenous iron supplementation (IVIS). Anemia and blood transfusions are associated with an increased risk of delirium. The aim of this research was to assess the effectiveness and safety of using IVIS in a prehabilitation program. MATERIAL AND METHODS: Patients ≥70 y who underwent abdominal surgery between November 2015 and June 2018 were included in this single-center prospective cohort study. All patients were prehabilitated; however, only anemic patients received a single dose of 1000 mg intravenous iron (ferric carboxymaltose) to increase preoperative hemoglobin levels (IVIS group). Nonanemic patients received standard care (SC). The hemoglobin levels (primary outcome) were assessed at the outpatient clinic visit, at admission, and at discharge. Secondary outcomes were postoperative delirium, postoperative anemia, blood transfusion, complications other than delirium, and length of hospital stay. All outcomes were compared between the IVIS group and SC group. RESULTS: Of all patients (n = 248), 97 anemic patients received IVIS (39%). Of the anemic patients, 50 patients (52%) had iron deficiency. Initial differences in hemoglobin concentrations between the IVIS group and SC group at T1 and T2 (7.2 versus 8.8; P < 0.001 and 7.4 versus 8.6; P = 0.023, respectively) were no longer present at discharge (6.6 versus 7.2; P = 0.35). No statistically significant differences were observed for all secondary outcomes between the IVIS group and the SC group. No infusion-related adverse events occurred. CONCLUSIONS: Adding IVIS to prehabilitation programs is safe and diminishes differences in these concentrations between preoperatively anemic and nonanemic patients. IVIS may be worthwhile as an additional component of prehabilitation programs. Results merit further investigation.

Two-year Outcome of Quality of Life and Health Status for the Elderly with Chronic Limb-threatening Ischemia.

PURPOSE: In elderly patients with chronic limb-threatening ischemia (CLTI), there is little scientific understanding of the long-term changes of quality of life (QoL) and health status (HS) after treatment. The primary goal of this study was to provide long-term QoL and HS results for elderly CLTI patients after therapy. Treatments consisted of endovascular revascularization, surgical revascularization, or conservative treatment. Furthermore, the aim of this study was to identify the distinctive trajectories of QoL and HS. PATIENTS AND METHODS: CLTI patients aged ≥70 years were included in a prospective observational cohort study with a two-year follow-up. The WHOQOL-BREF was used to asses QoL. The 12-Item Short Form Health Survey was used to measure HS. The QoL and HS scores were compared to the scores in the general elderly Dutch population. Latent class trajectory analysis was used. RESULTS: A total of 195 patients were included in this study. After two years, in all treatment groups patients showed significantly higher physical QoL score compared to baseline and there was no significant difference with the corresponding values in the elderly Dutch population. In the latent class trajectory analysis, there were no overlapping risk factors for poorer QoL or HS. CONCLUSION: This study shows that QoL levels in surviving elderly CLTI patients in the long-term do not differ from the corresponding values for elderly in the general population. There were no disparities in sociodemographic, clinical and treatment characteristics associated with poorer QoL and HS. This study was carried out to encourage further analysis of the influence of biopsychosocial characteristics on QoL and HS in elderly CLTI patients.

Impact of the COVID-19 Lockdown Strategy on Vascular Surgery Practice: More Major Amputations than Usual.

BACKGROUND: The aim of this study is to investigate the impact of the coronavirus disease 2019 (COVID-19) lockdown period on the number and type of vascular procedures performed in the operating theater. METHODS: A total of 38 patients who underwent 46 vascular procedures during the lockdown period of March 16th until April 30th, 2020, were included. The control groups consisted of 29 patients in 2019 and 54 patients in 2018 who underwent 36 and 66 vascular procedures, respectively, in the same time period. Data were analyzed using SPSS Statistics. RESULTS: Our study shows that the lockdown during the COVID-19 pandemic resulted in a significant increase in the number of major amputations (42% in 2020 vs. 18% and 15% in 2019 and 2020, respectively; P-value 0.019). Furthermore, we observed a statistically significant difference in the degree of tissue loss as categorized by the Rutherford classification (P-value 0.007). During the lockdown period, patients presented with more extensive ischemic damage when than previous years. We observed no difference in vascular surgical care for patients with an aortic aneurysm. CONCLUSIONS: Measurements taken during the lockdown period have a significant effect on non-COVID-19 vascular patient care, which leads to an increased severe morbidity. In the future, policy makers should be aware of the impact of their measurements on vulnerable patient groups such as those with peripheral arterial occlusive disease. For these patients, medical care should be easily accessible and adequate.

Do Surgical Site Infections in Open Aortoiliac Surgery Differ Between Occlusive and Aneurysmal Arterial Disease?

BACKGROUND: Surgical site infections (SSI) are frequently seen after aortoiliac vascular surgery (2%-14%). Deep SSIs are associated with graft infection, sepsis, and mortality. This study evaluates the difference in incidence and nature of SSI following open aortoiliac surgery for aneurysmal disease compared to occlusive arterial disease. METHODS: A retrospective cohort study was conducted, including all consecutive patients who underwent open aortoiliac vascular surgery between January 2005 and December 2016 in the Amphia Hospital, Breda, the Netherlands. Patients were grouped by disease type, either aneurysmal or occlusive arterial disease. Data were gathered, including patient characteristics, potential risk factors, and development of SSI. Surgical site infections were defined in accordance with the criteria of the Centers for Disease Control. RESULTS: Between January 2005 and December 2016, a total of 756 patients underwent open aortoiliac surgery of which 517 had aortoiliac aneurysms and 225 had aortoiliac occlusive disease. The group with occlusive disease was younger, predominantly male, and had more smokers. After exclusion of 228 patients undergoing acute surgery, the SSI rate after elective surgery was 6.2%, with 10 of 301 SSIs in the aneurysmal group (3.0%) and 22 of 213 SSIs in the group with occlusive disease (10.3%, P < .001). Also, infection-related readmission and reintervention were higher after occlusive surgery, 6.6% versus 0.9% (P < .001) and 4.2% versus 0.9% (P = .003), respectively. Staphylococcus aureus was found as the most common pathogen, causing 64% of SSI in occlusive disease versus 10% in aneurysmal disease (P = .005). Logistic regression showed occlusive arterial disease and chronic renal disease were associated with SSI. CONCLUSION: Our study presents evidence for a higher rate of SSI in patients with aortoiliac occlusive disease compared to aortoiliac aneurysmal disease, in part due to inherent use of inguinal incision in patients with occlusive disease. All precautions to prevent SSI should be taken in patients undergoing vascular surgery for arterial occlusive disease.

Long-term outcomes of major abdominal surgery and postoperative delirium after multimodal prehabilitation of older patients.

PURPOSE: The long-term outcomes of surgery followed by delirium after multimodal prehabilitation program are largely unknown. We conducted this study to assess the effects of prehabilitation on 1-year mortality and of postoperative delirium on 1-year mortality and functional outcomes. METHODS: The subjects of this study were patients aged ≥ 70 years who underwent elective surgery for abdominal aortic aneurysm (AAA) or colorectal cancer (CRC) between January 2013, and June 2018. A prehabilitation program was implemented in November 2015, which aimed to optimize physical health, nutritional status, factors of frailty and preoperative anemia prior to surgery. The outcomes were assessed as mortality after 6 and 12 months, compared between the two treatment groups; and mortality and functional outcomes, compared between patients with and those without delirium. RESULTS: There were 627 patients (controls N = 360, prehabilitation N = 267) included in this study. Prehabilitation did not reduce mortality after 1 year (HR 1.31 [95% CI 0.75-2.30]; p = 0.34). Delirium was significantly associated with 1-year mortality (HR 4.36 [95% CI 2.45-7.75]; p < 0.001) and with worse functional outcomes after 6 and 12 months (KATZ ADL p = 0.013 and p = 0.004; TUG test p = 0.041 and p = 0.011, respectively). CONCLUSIONS: The prehabilitation program did not reduce 1-year mortality. Delirium and the burden of comorbidity are both independently associated with an increased risk of 1-year mortality and delirium is associated with worse functional outcomes. TRIAL REGISTRATION: Dutch Trial Registration, NTR5932. https://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5932 .

Abdominal aortic aneurysm patients remain at risk for delirium on the surgical ward after intensive care unit dismissal.

BACKGROUND: The incidence of delirium following open abdominal aortic aneurysm (AAA) surgery is significant, with incidence rates ranging from 12% to 33%. However, it remains unclear on what level of care a delirium develops in AAA patients. The aim of this study was to investigate the incidence of delirium in the ICU and on the surgical ward after AAA surgery. METHODS: A single-center retrospective cohort study was conducted that included all patients treated electively for an open AAA repair and patients who underwent emergency treatment for a ruptured AAA between 2013 and 2018. The diagnosis of delirium was verified by a psychiatrist or geriatrician using the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria. The incidence of delirium was calculated. Cox proportional hazards regression analyses were used to analyze 6- and 12-month survival. RESULTS: A total of 135 patients were included, 46 patients (34%) had a delirium during admission. Of these, 30 patients (65%) developed a delirium in the ICU and 16 patients (35%) on the surgical ward. There was no significant difference in six months and twelve months mortality between the ICU and ward delirium groups (HR=1.64, 95% CI: 0.33-8.13, and HR=1.12, 95% CI: 0.28-4.47, respectively). CONCLUSIONS: Delirium frequently occurs in patients who undergo AAA surgery. This study demonstrated that patients on the surgical ward remain at risk of developing a delirium after ICU dismissal. Patients with ICU delirium differ in clinical characteristics and outcomes from patients with a delirium on the surgical ward.

Quality of Life and Traditional Outcome Results at 1 Year in Elderly Patients Having Critical Limb Ischemia and the Role of Conservative Treatment.

INTRODUCTION: Revascularization is the cornerstone of the treatment of critical limb ischemia (CLI), but the number of elderly frail patients increase. Revascularization is not always possible in these patients and conservative therapy seems to be an option. The goals of this study are to analyze the 1-year quality of life (QoL) results and mortality rates of elderly patients with CLI and to investigate if conservative treatment could be an acceptable treatment option. METHODS: Patients with CLI ≥70 years old were included in a prospective observational cohort study in 2 hospitals in the Netherlands between 2012 and 2016 and were divided over 3 treatment modalities: endovascular therapy, surgical revascularization, and conservative treatment. The World Health Organization Quality of Life (WHOQoL-Bref) instrument, a generic QoL assessment tool that includes components of physical, psychological, social relationships and environment, was used to evaluate QoL at baseline, 6 months, and 1 year. RESULTS: In total, 195 patients (56% male, 33% Rutherford 4, mean age of 80) were included. Physical QoL significantly increased after surgical (10.4 vs 14.9, P < .001), endovascular (10.9 vs 13.7, P < .001), and conservative therapy (11.6 vs 13.2, P = .01) at 1 year. One-year mortality was relatively low after surgery (10%) compared to endovascular (40%) and conservative therapy (37%). CONCLUSION: The results of this study could not be used to designate the superior treatment used in elderly patients with CLI. Conservative treatment could be an acceptable treatment option in selected patients with CLI unfit for revascularization. Treatment of choice in elderly patients with CLI is based on multiple factors and should be individualized in a shared decision-making process.

A mortality prediction model for elderly patients with critical limb ischemia.

OBJECTIVE: To aid physicians in the process of shared decision-making, many predictive models for critical limb ischemia (CLI) have been constructed. However, none of these models is in widespread use. Predicting survival outcomes for a specific individual may be used to guide treatment selection. The aim of this study was to construct a 6-month survival-predicting model representative of elderly patients with CLI undergoing surgical or endovascular treatment. METHODS: An observational cohort study including all patients with CLI aged ≥65 years who underwent surgical or endovascular treatment of CLI between January 2013 and June 2018 was conducted. The model to predict survival at 6 months was based on a multivariable Cox proportional hazards regression model and a penalized likelihood method. The performance of the model was judged by means of the area under the receiver operating characteristic curve. RESULTS: In total, 449 patients were included in the study population. The median age was 76 years (range, 65-97 years), and 52.8% of the population was male. Surgical treatment was performed in 303 patients (67.5%), and 146 underwent endovascular treatment (32.5%). The estimated 30-day survival was 92.7% (standard error [SE], 1.2%); 6-month survival, 80% (SE, 1.9%); and 12-month survival, 71% (SE, 2.1%). Variables with the strongest association with 6-month mortality were age, living in a nursing home, physical impairment, and American Society of Anesthesiologists class. The area under the receiver operating characteristic curve of the 6-month mortality model was 0.81 (95% confidence interval, 0.76-0.85; P < .001). CONCLUSIONS: A prediction model constructed for 6-month mortality of elderly patients undergoing surgical or endovascular treatment of CLI showed that age, living in a nursing home, physical impairment, and American Society of Anesthesiologists class have the highest association with an increase in mortality. These factors may be used to identify patients at risk for mortality in shared decision-making.

Incidence and Risk Factors for Delirium in Elderly Patients with Critical Limb Ischaemia.

OBJECTIVE: Delirium is associated with adverse outcomes, such as increased mortality and prolonged hospital stay. Information on the risk factors for delirium in elderly patients with critical limb ischaemia (CLI) is scarce. The aim of this study was to analyse the incidence of delirium and to identify risk factors for delirium in elderly patients undergoing surgical or endovascular treatment. METHODS: A retrospective cohort study was conducted including patients aged ≥ 65 years undergoing surgical or endovascular treatment for CLI between January 2013 and June 2018. Delirium was scored using the DOSS (Delirium Observation Screening Scale) and the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria. Risk factors for delirium were analysed using logistic regression. The discriminative ability of the model was calculated using the area under the receiver operating characteristics (AUROC) curve. RESULTS: In total, 392 patients were included, of which 70 (17.9%) developed delirium. Factors associated with an increased risk of delirium were: age, odds ratio (OR) 1.05 (95% confidence interval (CI) 1.0-1.1), history of femoral endarterectomy, OR 4.7 (95% CI 1.5-15), physical impairment, OR 2.2 (95% CI 1.1-4.5), history of delirium, OR 2.7 (95% CI 1.4-5.3), general anaesthesia, OR 2.6 (95% CI 1.2-5.7) and pre-operative anaemia, OR 5.9 (95% CI 2.3-15). The AUROC was .82 (95% CI 0.76-0.87, p < .001). Delirium was associated with more respiratory, renal and surgical complications, as well as a prolonged hospital stay and a more frequent discharge to a nursing home. CONCLUSION: Delirium occurs frequently in patients with critical limb ischaemia undergoing any type of invasive treatment. This study identified multiple risk factors for delirium that may be helpful to delineate patients susceptible to its development.

Post-EVAR aneurysm sac shrinkage is prognostically favorable, but does not justify withholding follow-up.

BACKGROUND: One of the main drawbacks of endovascular aortic aneurysm repair (EVAR) compared to open aortic surgery is the possibility of developing endoleaks and secondary aneurysm rupture, requiring frequent imaging follow-up. This study aims to identify prognostic factors that could be incorporated in follow-up protocols, which might lead to better personalized, lower cost and safe EVAR follow-up. METHODS: A retrospective study was performed including all patients who underwent elective EVAR from January 2000 to December 2015. Follow-up data were gathered by reviewing medical files for radiographic imaging. Linear and logistic regressions were used to assess predictive factors for aneurysm shrinkage. RESULTS: In 361 patients, aneurysm sac shrinkage of 10 mm or more was measured in 152 (42.1%) patients. Patients with ≥10-mm aneurysm shrinkage had fewer endoleaks (4.3% vs. 24.6%, P<0.0001) and fewer re-interventions for endoleak (3.0% vs. 10.1%, P=0.007). Aneurysm sac shrinkage was correlated with the absence of endoleak development (OR 0.36, 95% CI 0.19-0.66, P=0.001). In patients who had achieved ≥10-mm shrinkage of the aneurysm sac, no further significant growth was seen, compared to 38 (15.3%) patients who did not attain size reduction (P<0.001). CONCLUSIONS: Once patients achieve ≥10-mm aneurysm sac shrinkage, they are less prone to developing subsequent aneurysm growth and have significantly lower risk of requiring surgery for endoleaks. However, a small number of patients remain at risk of requiring endoleak surgery after aneurysm shrinkage. Therefore, we would not recommend ceasing life-long imaging follow-up after significant aneurysm sac shrinkage, though it might be safe to increase the interval of follow-up.

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.

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.

A multicomponent prehabilitation pathway to reduce the incidence of delirium in elderly patients in need of major abdominal surgery: study protocol for a before-and-after study.

BACKGROUND: Due to the increase in elderly patients who undergo major abdominal surgery there is a subsequent increase in postoperative complications, prolonged hospital stays, health-care costs and mortality rates. Delirium is a frequent and severe complication in the 'frail' elderly patient. Different preoperative approaches have been suggested to decrease incidence of delirium by improving patients' baseline health. Studies implementing these approaches are often heterogeneous, have a small sample and do not provide high-quality or successful strategies. The aim of this study is to prevent postoperative delirium and other complications by implementing a unique multicomponent and multidisciplinary prehabilitation program. METHODS: This is a single-center controlled before-and-after study. Patients aged ≥70 years in need of surgery for colorectal cancer or an abdominal aortic aneurysm are considered eligible. Baseline characteristics (such as factors of frailty, physical condition and nutritional state) are collected prospectively. During 5 weeks prior to surgery, patients will follow a prehabilitation program to optimize overall health, which includes home-based exercises, dietary advice and intravenous iron infusion in case of anaemia. In case of frailty, a geriatrician will perform a comprehensive geriatric assessment and provide additional preoperative interventions when deemed necessary. The primary outcome is incidence of delirium. Secondary outcomes are length of hospital stay, complication rate, institutionalization, 30-day, 6- and 12-month mortality, mental health and quality of life. Results will be compared to a retrospective control group, meeting the same inclusion and exclusion criteria, operated on between January 2013 and October 2015. Inclusion of the prehabilitation cohort started in November 2015; data collection is ongoing. DISCUSSION: This is the first study to investigate the effect of prehabilitation on postoperative delirium. The aim is to provide evidence, based on a large sample size, for a standardized multicomponent strategy to improve patients' preoperative physical and nutritional status in order to prevent postoperative delirium and other complications. A multimodal intervention was implemented, combining physical, nutritional, mental and hematinic optimization. This research involves a large cohort, including patients most at risk for postoperative adverse outcomes. TRIAL REGISTRATION: The protocol is retrospectively registered at the Netherlands National Trial Register (NTR) number: NTR5932 . Date of registration: 05-04-2016.

Cost-effectiveness of the treatments for critical limb ischemia in the elderly population.

OBJECTIVE: The treatment of critical limb ischemia (CLI), with the intention to prevent limb loss, is often an intensive and expensive therapy. The aim of this study was to examine the cost-effectiveness of endovascular and conservative treatment of elderly CLI patients unsuitable for surgery. METHODS: In this prospective observational cohort study, data were gathered in two Dutch peripheral hospitals. CLI patients aged 70 years or older were included in the outpatient clinic. Exclusion criteria were malignant disease, lack of language skills, and cognitive impairment; 195 patients were included and 192 patients were excluded. After a multidisciplinary vascular conference, patients were divided into three treatment groups (endovascular revascularization, surgical revascularization, or conservative therapy). Subanalyses based on age were made (70-79 years and ≥80 years). The follow-up period was 2 years. Cost-effectiveness of endovascular and conservative treatment was quantified using incremental cost-effectiveness ratios (ICERs) in euros per quality-adjusted life-years (QALYs). RESULTS: At baseline, patients allocated to surgical revascularization had better health states, but the health states of endovascular revascularization and conservative therapy patients were comparable. With an ICER of €38,247.41/QALY (∼$50,869/QALY), endovascular revascularization was cost-effective compared with conservative therapy. This is favorable compared with the Dutch applicable threshold of €80,000/QALY (∼$106,400/QALY). The subanalyses also established that endovascular revascularization is a cost-effective alternative for conservative treatment both in patients aged 70 to 79 years (ICER €29,898.36/QALY; ∼$39,765/QALY) and in octogenarians (ICER €56,810.14/QALY; ∼$75,557/QALY). CONCLUSIONS: Our study has shown that endovascular revascularization is cost-effective compared with conservative treatment of CLI patients older than 70 years and also in octogenarians. Given the small absolute differences in costs and effects, physicians should also consider individual circumstances that can alter the outcome of the intervention. Cost-effectiveness remains one of the aspects to take into consideration in making a clinical decision.

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.