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.

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.

Quality of Life in Patients Suffering from Critical Limb Ischemia.

BACKGROUND: Various treatment options exist for patients suffering from critical limb ischemia (CLI). These options consist of endovascular procedures, surgical revascularization, primary amputation, or conservative therapy. The effect of the treatment is traditionally focused on outcomes, such as primary patency and limb salvage, though quality of life (QoL) is considered an important additional primary end point in a more patient-oriented healthcare system. The aim of this systematic review is to explore the best clinical decision making possible, to increase QoL in CLI patients. METHODS: This review is based on a systematic electronic literature search using the PubMed and EMBASE databases. Articles evaluating QoL in patients with CLI were selected for further analysis. Only prospective studies, written in English, describing QoL and health status (HS) after endovascular or surgical revascularization, amputation or conservative therapy were considered for inclusion. Treatment results were divided into short-term (≤3-month follow-up) and long-term results (≥1-year follow-up) to achieve a clear view of the QoL in patients suffering for CLI patients. RESULTS: Twenty-five articles describing HS in patients suffering from CLI were included. It was found that while most of these articles reported HS of patients, rarely did they report on QoL. As a result, it is difficult to determine the best treatment to increase HS as studies that focus on the comparison of treatment modalities are lacking. All 4 treatment modalities can raise HS in the short and the long terms; however, endovascular and surgical revascularization seem to positively effect HS the most. QoL results are lacking in both the short and long terms. CONCLUSIONS: All treatment methods included in the study resulted in an increase in patients' HS in both short and long terms. More comparative studies with inclusion of all different treatments of CLI are needed to assist in clinical decision making and perform tailored interventions for the individual patient. QoL and HS are confusingly used in current international literature with abundant HS research. To take patients individual opinions more into account, focus on QoL research is needed to designate the superior treatment in patients suffering from CLI.

Life Expectancy in Nonagenarians Suffering from Critical Limb Ischemia.

BACKGROUND: Peripheral arterial disease has become an increasing problem in the aging population of the western world with a prevalence of 10-14%. This will result in a growing group of nonagenarians being referred to vascular surgeons, with an estimated growth of 2.5 times the number of nonagenarians between 2015 and 2040. Outcome results of nonagenarians suffering from critical limb ischemia (CLI) are scarce, which can cause difficulties in choosing superior therapy options. We propose that the life expectancy of nonagenarians suffering CLI compared to the overall population of nonagenarians is valuable information required in clinical decision-making. METHODS: Between January 2012 and October 2015, all patients suffering from CLI were retrospectively reviewed in the Amphia Hospital, Breda, The Netherlands. Patients aged ≥90 years at admission were exclusively included. The main outcome result of this study is the life expectancy of nonagenarians suffering from CLI. Closely related to life expectancy is the primary end point of mortality. Secondary end points were adverse events, reoperations, and limb salvage. RESULTS: A total of 36 patients were included in this study of which 27 were women. The median age was 92 years. Conservative therapy was performed in 61% of the patients. Based on 24 deaths (of which 19 were women), the mortality rate ratio of the study group relative to the Dutch population was 3.13 (95% confidence interval [CI], 2.00-4.66; P < 0.000001), adjusted for age and gender. Life expectancy in years of the total Dutch population at age 90 years in 2013 was 3.83 for men and 4.54 for women in contrast to, respectively, 1.23 (95% CI, 0.50-5.69) and 2.70 (95% CI, 1.76-3.74) years in our patient group. CONCLUSIONS: CLI is a severe disease in nonagenarians with a dreadful life expectancy of 1.23 and 2.7 years for men and women, respectively, corresponding with an age- and gender-adjusted mortality rate ratio of 3.13 relative to the Dutch population. Individual factors such as preoperative status, arterial occlusive lesion, and especially predicted postoperative quality of life are important parameters in clinical decision-making. Results of conservative therapy might be acceptable in selected patients, but more focus on quality of life is needed to be conclusive.

The clinical applicability of an automated plethysmographic determination of the ankle-brachial index after vascular surgery.

An automated ankle-brachial index device could lead to potential time savings and more accuracy in ankle-brachial index-determination after vascular surgery. This prospective cross-sectional study compared postprocedural ankle-brachial indices measured by a manual method with ankle-brachial indices of an automated plethysmographic method. Forty-two patients were included. No significant difference in time performing a measurement was observed (1.1 min, 95% CI: -0.2 to +2.4; P = 0.095). Mean ankle-brachial index with the automated method was 0.105 higher (95% CI: 0.017 to 0.193; P = 0.020) than with the manual method, with limits of agreement of -0.376 and +0.587. Total variance amounted to 0.0759 and the correlation between both methods was 0.60. Reliability expressed as maximum absolute difference (95% level) between duplicate ankle-brachial index-measurements under identical conditions was 0.350 (manual) and 0.152 (automated), although not significant (p = 0.053). Finally, the automated method had 34% points higher failure rate than the manual method. In conclusion based on this study, the automated ankle-brachial index-method seems not to be clinically applicable for measuring ankle-brachial index postoperatively in patients with vascular disease.

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.

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.

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.

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.

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.