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.

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.

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.

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.

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.

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 .

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.

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.

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.

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.

Life Expectancy and Outcome of Different Treatment Strategies for Critical Limb Ischemia in the Elderly Patients.

BACKGROUND: The treatment of critical limb ischemia (CLI) in the elderly patients is challenging because of the comorbidity and fragility of these patients. We analyzed survival in relation to different treatment options and estimated life expectancy of our study group by age and gender. METHODS: All patients aged ≥70 years, presenting with chronic CLI, between 2006 and 2013 were included. The treatment was conservative, endovascular, surgical, or by primary major amputation. The interest was in the effect of conservative versus nonconservative treatment on survival. Furthermore, we compared mortality and life expectancy between the study population to the overall Dutch population by age and gender. RESULTS: In total, 686 legs in 651 patients were treated. Initial treatment of patients was conservative (n = 181), endovascular (n = 259), surgical (n = 169), or amputation (n = 42). The overall 1-year mortality was 29%. Patients were stratified by age: 70-79 (n = 350) years and ≥80 (n = 301) years. Higher mortality rate ratios (RR) were found in octogenarians compared with patients aged 70-79 years, in the endovascular (P < 0.001) and surgical (P < 0.001) group. The mortality RRs of conservative relatively to nonconservative treatment was 0.84 (95% confidence interval: 0.65-1.09; P = 0.19), not significantly differing between both age groups (P = 0.74). The mortality RR of 3.72 of our study population to the Dutch general population was high, with an excess mortality of 272%. Life expectancy at the age of 70 years was substantially decreased by 9 and 8 years for, respectively, the male and female population. CONCLUSIONS: Mortality rates in elderly patients with CLI are high, corresponding with a decreased life expectancy, regardless of the type of intervention. Revascularization is associated with high periprocedural mortality, especially in octogenarians. Conservative treatment is noninferior to nonconservative treatment in terms of mortality and should be considered as the treatment in octogenarians with substantial comorbidity.

Reinterventions after Endovascular Revascularization in Elderly Patients with Critical Limb Ischemia: An Observational Study.

BACKGROUND: Endovascular-first strategy for critical limb ischemia is widely accepted, especially in elderly patients, because of the increasing patency rates and minimally invasive character. Nonetheless, the impact of reinterventions because of endovascular treatment failure in this population is not well known. The aim of this study was to evaluate the reintervention rate and outcomes following reinterventions. METHODS: Patients aged >70 years with critical limb ischemia as a result of aortoiliac, femoropopliteal, and/or crural disease, treated by "endovascular-first strategy" between 2006 and 2013, were retrospectively analyzed. Follow-up was until 31 December 2014. Primary end point was freedom from reintervention or major amputation. Secondary outcome measures were limb salvage and mortality after reintervention. Reintervention was defined as endovascular or surgical re-revascularization and categorized into early reintervention (<3 months) and late reintervention (>3 months). RESULTS: In total, 263 patients were treated by endovascular revascularization. The majority (60%) of the treated lesion was located in the femoropopliteal segment. In total, a reintervention was performed in 32%, with 48% performed within 3 months. Freedom from reintervention or major amputation at 1 and 3 years was 0.71 ± 0.03 and 0.61 ± 0.03, respectively. The 1-year Kaplan-Meier estimate amputation-free survival was 0.35 ± 0.06 in the early reintervention group, compared with 0.73 ± 0.06 in the late reintervention group and 0.71 ± 0.04 in the no reintervention group (P < 0.001; log rank). The 1-year mortality in the early reintervention group was 0.35 ± 0.06, compared with 0.14 ± 0.05 in the late reintervention group and 0.29 ± 0.04 in the group who did not require reintervention (P = 0.047; log rank). CONCLUSIONS: Endovascular revascularization first strategy for critical limb ischemia results in high reintervention rates in elderly patients. Failure of the endovascular revascularization requiring early reintervention is associated with lower amputation-free survival.

Infection Risk Following Common Femoral Artery Endarterectomy Versus a Hybrid Procedure.

BACKGROUND: Hybrid revascularization combines open lower extremity surgery and endovascular procedures to simultaneously treat atherosclerotic lesions on multiple levels in patients with peripheral arterial occlusive disease (PAD). Hybrid surgery appears to be a safe strategy for multilevel stenosis revascularization, though the risk of surgical site infection (SSI) has not been clearly investigated. This study evaluates the development of SSI following common femoral artery endarterectomy (CFE) and hybrid revascularization procedures. METHODS: A retrospective study was performed including all patients undergoing CFE, as standalone or as part of a hybrid procedure, due to PAD between January 2013 and December 2016. Preoperative, intraoperative, clinical, and follow-up information was gathered prospectively and reviewed retrospectively. The presence of SSI was recorded based on criteria of the Centre for Disease Control. RESULTS: A total of 229 CFEs were performed. One hundred thirty-two as a standalone procedure, 65 combined with iliofemoral angioplasty, and 32 combined with peripheral angioplasty. Nineteen patients (8.3%) developed an SSI, of which 4 were deep infections. Ten infections (7.6%) occurred in the CFE-only group, 5 (7.7%) in the iliofemoral hybrid group, and 4 (12.5%) in the peripheral hybrid group (P = 0.65). Five patients (2.1%) required surgery to control the infection. The mean duration of stay was 5 days for patients without SSI versus 20 days for patients who developed an SSI (P < 0.0001). CONCLUSIONS: The hybrid procedure combining open femoral endarterectomy with endovascular revascularization is a safe procedure with no significant differences in infection rates between open surgery, central, or peripheral hybrid revascularization.

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.

Dementia in Patients Suffering from Critical Limb Ischemia.

BACKGROUND: Critical limb ischemia (CLI) is a disease that is most prevalent in the elderly population. This group of patients includes patients suffering from comorbidities such as dementia. Mortality rates of both CLI and dementia are higher when compared with the nonaffected population. These demented vascular patients are often deemed unfit for surgery and at risk of respiratory and cardiovascular adverse events. Unfortunately, current literature is lacking in to determining the optimal treatment for demented patients suffering from CLI. The purpose of this study is to determine the prevalence of dementia in patients suffering from CLI, with special interest in the mortality rates of these patients. METHODS: Between January 2012 and October 2015, all patients aged over 70 and suffering from CLI were retrospectively reviewed in the Amphia Hospital, Breda, The Netherlands. Patients with diagnosed dementia before admission by a geriatrician were included in this study. Baseline characteristics were retrieved from patients' medical charts. Primary end point of this study is mortality and the secondary end points include adverse events, reinterventions, and limb salvage. RESULTS: A total of 369 patients suffering from CLI were diagnosed between January 2012 and October 2015. Thirty-one patients (8%) diagnosed with both dementia and CLI were included in this study with a mean age of 82 years old. Conservative therapy was selected as the therapy of choice in 61% of the patients. There was a mortality rate of 32% after 6 months, increasing to 52% after 1 year and 92% after 2 years. Limb salvage rates after 30 days were 84%, dropping to 77% after 6 months. CONCLUSIONS: Eight percent of CLI patients aged above 70 years old are suffering from dementia. Demented patients suffering from CLI are a frail group of elderly patients with a high mortality rate of 52% after 1-year follow-up. Therapy of choice should probably be selected following mutual agreement between vascular surgeons, individual patients, and their families, taking postoperative quality of life, life expectation, and anatomical arterial lesions into account.

Adverse events after treatment of patients with acute limb ischemia.

BACKGROUND: To assess the outcome and the occurrence and consequences of adverse events (AEs) after treatment of acute limb ischemia (ALI). METHODS: Retrospective analysis on intra-arterial thrombolysis (group I) and thromboembolectomy (group II). Outcome measures were primary patency and limb salvage rates. AEs and consequences were registered during admission and 30 days after discharge. RESULTS: A total of 238 procedures were included (group I, 173 vs. group II, 65). The primary patency (P = 0.144) and limb salvage rates (P = 0.166) were not significantly different between both groups. A total of 195 AEs were registered. Most AEs were procedure related and resulted in surgical reintervention (77% vs. 76%). Some AEs resulted in irreversible physical damage (15% vs. 25%) and death (6% vs. 12%). CONCLUSIONS: Both, intra-arterial thrombolysis and thromboembolectomies are adequate therapies; however, they result in a wide variety of AEs resulting in serious morbidity and even death.

Current factors of fragility and delirium in vascular surgery.

BACKGROUND: Vascular surgery patients are frequently deemed to be in a frail clinical condition and at risk for delirium. Therefore, we evaluated the incidence and independent perioperative risk factors for delirium. In addition, we describe factors on frailty in the various vascular disease groups in current practice. METHODS: This observational longitudinal study included 206 selected patients who were referred to a vascular surgery ward of a large-sized teaching hospital (Amphia Hospital, Breda, The Netherlands) for critical limb ischemia (n = 80), diabetic foot ulcers (n = 27), abdominal aortic aneurysm (AAA) (n = 62), and carotid surgery (n = 37) between April 2013 and December 2013. Data on factors that characterize frailty were collected. Delirium was scored using the Delirium Observation Screening Scale. Multivariable logistic regression analysis was performed to find independent risk factors for delirium. RESULTS: Delirium was present in 24% of the critical limb ischemia patients, in 19% of the patients with a diabetic foot ulcer, in 7% of the patients with an AAA, and in 8% of the patients undergoing carotid surgery (P > 0.05). Of the patients with critical limb ischemia and a delirium, 53% were octogenarians. Multivariable stepwise logistic regression analysis revealed that history of delirium and nurse help at patient's home were independently associated with delirium. Patients with critical limb ischemia scored worse on factors related to frailty compared with the other disease groups in our current clinical practice on vascular surgery. CONCLUSIONS: Delirium is a frequent complication in vascular surgery clinical practice, especially in the elderly. Nurse visits at patients' homes and the Amphia Risk Score for delirium were independent risk factors for delirium in our study population. In this study, we identified patients with critical limb ischemia as the most frail and vulnerable.

Endovascular Revascularization and Supervised Exercise for Peripheral Artery Disease and Intermittent Claudication: A Randomized Clinical Trial.

IMPORTANCE: Supervised exercise is recommended as a first-line treatment for intermittent claudication. Combination therapy of endovascular revascularization plus supervised exercise may be more promising but few data comparing the 2 therapies are available. OBJECTIVE: To assess the effectiveness of endovascular revascularization plus supervised exercise for intermittent claudication compared with supervised exercise only. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial of 212 patients allocated to either endovascular revascularization plus supervised exercise or supervised exercise only. Data were collected between May 17, 2010, and February 16, 2013, in the Netherlands at 10 sites. Patients were followed up for 12 months and the data were analyzed according to the intention-to-treat principle. INTERVENTIONS: A combination of endovascular revascularization (selective stenting) plus supervised exercise (n = 106) or supervised exercise only (n = 106). MAIN OUTCOMES AND MEASURES: The primary end point was the difference in maximum treadmill walking distance at 12 months between the groups. Secondary end points included treadmill pain-free walking distance, vascular quality of life (VascuQol) score (1 [worst outcome] to 7 [best outcome]), and 36-item Short-Form Health Survey (SF-36) domain scores for physical functioning, physical role functioning, bodily pain, and general health perceptions (0 [severe limitation] to 100 [no limitation]). RESULTS: Endovascular revascularization plus supervised exercise (combination therapy) was associated with significantly greater improvement in maximum walking distance (from 264 m to 1501 m for an improvement of 1237 m) compared with the supervised exercise only group (from 285 m to 1240 m for improvement of 955 m) (mean difference between groups, 282 m; 99% CI, 60-505 m) and in pain-free walking distance (from 117 m to 1237 m for an improvement of 1120 m vs from 135 m to 847 m for improvement of 712 m, respectively) (mean difference, 408 m; 99% CI, 195-622 m). Similarly, the combination therapy group demonstrated significantly greater improvement in the disease-specific VascuQol score (1.34 [99% CI, 1.04-1.64] in the combination therapy group vs 0.73 [99% CI, 0.43-1.03] in the exercise group; mean difference, 0.62 [99% CI, 0.20-1.03]) and in the score for the SF-36 physical functioning (22.4 [99% CI, 16.3-28.5] vs 12.6 [99% CI, 6.3-18.9], respectively; mean difference, 9.8 [99% CI, 1.4-18.2]). No significant differences were found for the SF-36 domains of physical role functioning, bodily pain, and general health perceptions. CONCLUSIONS AND RELEVANCE: Among patients with intermittent claudication after 1 year of follow-up, a combination therapy of endovascular revascularization followed by supervised exercise resulted in significantly greater improvement in walking distances and health-related quality-of-life scores compared with supervised exercise only. TRIAL REGISTRATION: Netherlands Trial Registry Identifier: NTR2249.

The current position of precuffed expanded polytetrafluoroethylene bypass grafts in peripheral vascular surgery.

OBJECTIVE: Long-term results of precuffed expanded polytetrafluoroethylene (ePTFE) grafts used for peripheral bypass surgery are lacking. The aim of this study was to obtain the long-term outcomes of precuffed ePTFE grafts compared with autologous saphenous vein (ASV) grafts used in patients with peripheral arterial disease (PAD). METHODS: A single-institution retrospective study of precuffed ePTFE and ASV graft performances in patients with PAD was undertaken between January 2004 and December 2012. Five-year primary patency, secondary patency, and limb salvage rates were determined by Kaplan-Meier analyses. RESULTS: A total of 467 bypass grafts were included in this study (169 precuffed ePTFE grafts and 298 ASV grafts). Secondary patency rates of ePTFE vs ASV at 1 and 5 years, respectively, were as follows: for 134 supragenicular femoropopliteal bypasses, 60% and 27% vs 89% and 85% (P < .05); for 190 infragenicular femoropopliteal bypasses, 40% and 25% vs 86% and 79% (P < .05); and for 84 femorocrural bypasses, 30% and 14% vs 50% and 50% (P < .05). Five-year limb salvage rates of ePTFE vs ASV for supragenicular femoropopliteal bypasses were 82% vs 94% (P = .16); for infragenicular femoropopliteal bypasses, 41% vs 92% (P < .05); and for femorocrural bypasses, 43% vs 64% (P = .06). CONCLUSIONS: ASV bypasses are still the first-choice conduit in peripheral bypass surgery performed in patients with PAD. Precuffed ePTFE bypasses are acceptable alternatives in the absence of adequate autologous vein.