Tilburg University
Various aspects of critical limb ischemia in the elderly, especially the role of
conservative therapy and quality of life
Steunenberg, S.L.
Publication date:
2019
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Steunenberg, S. L. (2019). Various aspects of critical limb ischemia in the elderly, especially the role of conservative therapy and quality of life. Trichis.
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Various aspects of critical limb ischemia in the elderly, especially the role of conservative therapy and quality of life
PhD thesis, Tilburg University, with summary in Dutch
Proefschrift, Tilburg Universiteit, met een samenvatting in Nederlands
Copyright © S.L. Steunenberg 2019
Introduction
Peripheral arterial disease (PAD) is characterized by arterial insufficiency of the lower limbs. The Rutherford classification is commonly used as staging system for describing PAD. Rutherford stage 1‐3 describes a mild to severe claudication defined as fatigue or pain in the calves, mostly affected after exercise and relieved by rest.1 Primary treatment consists of supervised exercise training for at least three months and revascularization is indicated in the minority of the patients.2 Rutherford stage 4‐6 is defined as critical limb ischemia (CLI), characterized by chronic ischemic rest pain or ischemic ulceration or gangrene of the lower limbs due to hypoperfusion.1,3‐5 Due to the critical disturbed perfusion of the leg, the overall opinion in current practice is that revascularization is necessary to optimize circulation, reduce ischemic pain, permit wound healing and prevent major amputation.5 Prevalence of PAD in the overall population is approximately 12% and is mainly affected by aging, with a prevalence up to 20% in octogenarians. The annual incidence is 1.78‐2.29%.6‐8 Ten percent of the patients with PAD develop CLI.9 The prevalence of CLI in the global population is estimated at 0.8‐1.0%, with an annual incidence of 0.20% in patients >65 years old.5,10
Endovascular or surgical revascularization is the cornerstone of treatment for patients with CLI fit for surgery to achieve limb salvage and relieve pain. Based on the Bypass vs. Angioplasty in Severe Ischaemia of the Leg (BASIL) trial, the only randomized controlled trial in CLI patients, it was stated that patients with a life expectancy of two years or longer should be offered bypass surgery, while endovascular revascularization is suggested for patients expected to live less than two years.11 However, not all patients are suited for endovascular treatment due to varying comorbidities and the type of anatomical lesions. Aortic‐iliac and femoral lesions could anatomically be classified according to the Trans‐Atlantic Inter‐Society Consensus Document II (TASC). TASC A and B lesions have good results after endovascular treatment, but TASC C and D lesions (long lesions or severe arterial occlusions) are less suited for endovascular therapy and are more suitable for surgical therapy. Many TASC C and D lesion patients are excluded for endovascular treatment in the BASIL trial, hampering fair comparison between endovascular and surgical therapy.3,11,12
but Orimo et al stated that the evidence on which this definition is based is unknown. They refer to patients 65‐74 years old as “early elderly” and those over 75 years old as “late elderly”.13‐15 To describe the elderly CLI patients, the current literature shows a preference for age 70 or older, likely due to the aging of the world population and the increased life expectancy of the recent decades.11,16,17 Approximately 35% of the elderly patients suffering from CLI are considered frail.18‐20 Frailty is a state of increased vulnerability for poor maintenance of homeostasis after stressful events, thereby increasing the risk of adverse events.21 Treatment selection for elderly patients diverge from treatment of relatively young CLI patients due to their frailty and serious comorbidities, such as cardiovascular diseases and renal impairment.5 Endovascular or surgical revascularization is also often recommended for the treatment of elderly CLI patients. However, approximately 50% of the elderly patients are not suited for endovascular or surgical revascularization, causing a dilemma of treatment selection in current practice.5,11 The only alternative treatment options are conservative treatment and primary amputation. Primary amputation is considered a last resort treatment option and most surgeons seem to do everything to save the affected limb because of the expected loss of mobility and anticipated reduction in quality of life (QoL).22 Conservative treatment consisting of optimal pharmacological treatment seems to be a more common treatment option in recent years, in accordance with the prominent “do no further harm” concept, applicable in elderly patients deemed unsuitable for revascularization. As a result, patient reported outcome measurements (PROMS) are scarce in the current literature to guide clinical decision making in these frail elderly.23
experiences, beliefs, expectations and perceptions regarding physical, psychological, and social functioning. In assessing QoL, change is measured subjectively and can only be determined by the individual since it concerns patients’ own evaluation of their functioning.24,25 Questionnaires used to assess QoL include the Schedule for the Evaluation of the Individual Quality of Life‐Direct Weighting (SEIQoL) and the World Health Organization Quality of Life (WHOQOL) assessment instruments. The diversity in definitions of HS and QoL, inconsistent used questionnaires and the heterogeneous study populations affect results, hamper good comparisons of the current CLI literature. Endovascular and surgical revascularization, as well as primary amputation and conservative treatment could raise HS in the short and long term, but QoL results are lacking. The differences between QoL and HS results will be discussed in Chapter 4‐7 of this thesis.
To get more insight to some of the mentioned topics above, a prospective study (Kritieke ischemie bij Oudere Patient (KOP) study) is conducted among elderly CLI patients in the Amphia hospital Breda and the Bravis hospital, Roosendaal, the Netherlands in the period between January 2012 and February 2016. The KOP study is a prospective study that compares the results of the different treatment modalities in CLI with a specific interest in QoL and HS of patients. The primary results of the KOP study are presented in this thesis.
Aims of the thesis
The KOP study described in this thesis had several aims. The first was to zoom in on some subgroups in the elderly CLI population and to evaluate the effects of CLI and aging on outcome measures such as life expectancy and mortality. The second aim was to assess the QoL results of endovascular revascularization, surgical revascularization, and conservative treatment. The final aim was to examine the feasibility of conservative treatment as a treatment option in elderly patients suffering from CLI.
Outline of the thesis
Chapter 2. Dementia and CLI are both diseases that are prevalent in the elderly population. However, information about the prevalence and outcome of the combination of these two diseases is currently missing. Patients suffering from both diseases seem to be more frail and it is unclear whether revascularization is the best treatment for these patients. The prevalence of dementia among CLI patients and corresponding mortality rates could be valuable in the decision whether or not to perform revascularization. Therefore, in Chapter 3, the prevalence of dementia among patients suffering from CLI was examined and mortality rates were analyzed.
In Chapter 4, the current literature concerning QoL in elderly CLI patients was systematically reviewed. All available treatments for CLI, such as endovascular or surgical revascularization, primary amputation or conservative treatment were included and the differences between HS and QoL were observed. The results of the 195 included patients in the KOP‐study will be discussed in chapter 5 and 6. Chapter 5 evaluated the short‐term results of the KOP‐study according to an intention to treat method. Morbidity and mortality rates were assessed, with specific focus given to short‐term QoL. Long‐term QoL results and mortality rates at one year were presented in Chapter 6. In addition to the systematic review, we analyzed the outcome results of elderly patients suffering from CLI, measured by HS and QoL questionnaires in Chapter 7. Finally, our results and opinion about future perspectives were discussed in Chapter 8.
References
1. Rutherford RB, Baker JD, Ernst C, Johnston KW, Porter JM, Ahn S, et al. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg. 1997;26(3):517‐38. 2. Nicolai SP, Hendriks EJ, Prins MH, Teijink JA, group Es. Optimizing supervised exercise therapy for
patients with intermittent claudication. J Vasc Surg. 2010;52(5):1226‐33.
3. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG, et al. Inter‐Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. 2007;45 Suppl S:S5‐67.
4. Alabi O, Roos M, Landry G, Moneta G. Quality‐of‐life assessment as an outcomes measure in critical limb ischemia. J Vasc Surg. 2017;65(2):571‐8.
5. Farber A, Eberhardt RT. The Current State of Critical Limb Ischemia: A Systematic Review. JAMA Surg. 2016;151(11):1070‐7.
6. Criqui MH, Aboyans V. Epidemiology of peripheral artery disease. Circ Res. 2015;116(9):1509‐26. 7. Kalbaugh CA, Kucharska‐Newton A, Wruck L, Lund JL, Selvin E, Matsushita K, et al. Peripheral artery
disease prevalence and incidence estimated from both outpatient and inpatient settings among medicare fee‐for‐service beneficiaries in the atherosclerosis risk in communities (ARIC) study. J Am Heart Assoc. 2017;6(5).
8. Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, et al. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013;382(9901):1329‐40.
9. Nehler MR, Duval S, Diao L, Annex BH, Hiatt WR, Rogers K, et al. Epidemiology of peripheral arterial disease and critical limb ischemia in an insured national population. J Vasc Surg. 2014;60(3):686‐95 e2. 10. Biancari F. Meta‐analysis of the prevalence, incidence and natural history of critical limb ischemia. J
Cardiovasc Surg (Torino). 2013;54(6):663‐9.
11. Bradbury AW, Adam DJ, Bell J, Forbes JF, Fowkes FG, Gillespie I, et al. Bypass versus angioplasty in severe ischaemia of the leg (BASIL) trial: an intention‐to‐treat analysis of amputation‐free and overall survival in patients randomized to a bypass surgery‐first or a balloon angioplasty‐first revascularization strategy. J Vasc Surg. 2010;51(5 Suppl):5S‐17S. 12. Hardman RL, Jazaeri O, Yi J, Smith M, Gupta R. Overview of classification systems in peripheral artery disease. Semin Intervent Radiol. 2014;31(4):378‐88. 13. Orimo H. [Reviewing the definition of elderly]. Nihon Ronen Igakkai Zasshi. 2006;43(1):27‐34. 14. I; OYRHAMIHTKK. Redefining the elderly as aged 75 years and older: proposal from the joint committee of Japan gerontological society and the Japan geriatrics society. Geriatr Geron Int. 2017;17(7). 15. Roebuck. When does old age begin?: The evolution of the english definition. J Soc Hist. 1979;12(3):416‐ 28. 16. Brosi P, Dick F, Do DD, Schmidli J, Baumgartner I, Diehm N. Revascularization for chronic critical lower limb ischemia in octogenarians is worthwhile. J Vasc Surg. 2007;46(6):1198‐207. 17. Klaphake S, de Leur K, Mulder PGH, Ho GH, de Groot HGW, Veen EJ, et al. Life Expectancy and Outcome of Different Treatment Strategies for Critical Limb Ischemia in the Elderly Patients. Ann Vasc Surg. 2018;46:241‐8.
18. Morisaki K, Yamaoka T, Iwasa K, Ohmine T. Influence of frailty on treatment outcomes after revascularization in patients with critical limb ischemia. J Vasc Surg. 2017;66(6):1758‐64.
19. Okuyama M, Takeuchi H, Uchida HA, Kakio Y, Okuyama Y, Umebayashi R, et al. Peripheral artery disease is associated with frailty in chronic hemodialysis patients. Vascular. 2018;26(4):425‐31.
20. Raats JW, van Hoof‐de Lepper CC, Feitsma MT, Meij JJ, Ho GH, Mulder PG, et al. Current factors of fragility and delirium in vascular surgery. Ann Vasc Surg. 2015;29(5):968‐76.
21. Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, et al. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001;56(3):M146‐56.
22. Suckow BD, Goodney PP, Cambria RA, Bertges DJ, Eldrup‐Jorgensen J, Indes JE, et al. Predicting functional status following amputation after lower extremity bypass. Ann Vasc Surg. 2012;26(1):67‐78. 23. Thomas AR, Raats JW, Lensvelt MM, de Groot HG, Veen EJ, van der Laan L. Conservative Treatment in
24. Breek JC, de Vries J, van Heck GL, van Berge Henegouwen DP, Hamming JF. Assessment of disease impact in patients with intermittent claudication: discrepancy between health status and quality of life. J Vasc Surg. 2005;41(3):443‐50.
Abstract
Objective
Peripheral arterial disease (PAD) has become an increasing problem due to the aging population of the western world with a prevalence of 10 to 14%. This will result in a growing group of nonagenarians being referred to vascular surgeons, due to 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 endpoint of mortality. Secondary endpoints were adverse events, re‐operations and limb salvage.
Results
A total of 36 patients were included in this study of which 27 were females. The median age was 92 years old. Conservative therapy was performed in 61% of the patients. Based on 24 deaths (of which 19 females) the mortality rate ratio of the study group relatively to the Dutch population was 3.13 (95% CI: 2.00‐4.66; p<0.001), adjusted for age and gender. Life expectancy in years of the total Dutch population at age 90 in 2013 was 3.83 for males and 4.54 for females 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. Conclusion
Introduction
Critical limb ischemia (CLI), associated with chronic rest pain and ulceration or gangrene of the lower extremities, is the most severe presentation of peripheral arterial disease (PAD). PAD has become an increasing problem due to the aging population of the western world with a prevalence of 10 to 14%.1,2 This will result in a growing group of nonagenarians being referred to vascular surgeons, due to an estimated growth of 2.5 times the number of nonagenarians between 2015 and 2040.3 Elderly patients in general undergo physiological changes which impair the functional reserve and increase vulnerability. This can lead to poor maintenance of homeostasis after a stressor event, hence increasing the risk of adverse outcome. Patients undergoing vascular surgery are already at risk of adverse events like delirium and are prone to poor prognosis.4‐6 These facts describe the frailty of nonagenarians suffering from CLI. Nonagenarians suffering from CLI are often frail patients with several comorbidities, including myocardial ischemia, cerebrovascular events renal insufficiency. Prevalence of cognitive impairment is also high, but frequently undiagnosed.5 Known risk factors in CLI patients such as diabetes and active smoking are less present.5,7,8 This suggests a difference in elderly patients as opposed to younger patients suffering from CLI and therefore different outcome rates.
In nonagenarians suffering from CLI, the therapy options consist of endovascular procedures, surgical revascularisation, primary amputation and conservative therapy. Endovascular revascularisation, a minimal invasive procedure, with low complication rates, is often preferred to more invasive surgical procedures.8 However their heightened age and potential increased operative risk, nonagenarians who are reasonably fit, seem to possess a high tolerance to invasive vascular surgery.9,10 According to the BASIL‐trial, the decision whether or not to perform endovascular revascularisation or bypass surgery in patients with infra‐inguinal disease depends on a patients’ life expectancy. Endovascular revascularisation is preferred in patients with a life expectancy shorter than 2 years, as these patients are unlikely to benefit from the long‐term results of bypass surgery.11 Unfortunately, about half of the CLI patients presenting to vascular units are deemed unfit for open or endovascular revascularisation due to comorbidities or anatomical unsuitability.12 Conservative therapy with pain control and intensive wound care could be an acceptable option in these patients to avoid primary amputation.13
life expectancy of nonagenarians suffering CLI compared to the overall population of nonagenarians is valuable information required in clinical decision‐making. The current life expectancy of a Dutch nonagenarian is about 3.83 years for males and 4.54 years for females,14 but literature in regard to the life expectancy of nonagenarians suffering from CLI is lacking. The aim of this study is to describe the life expectancy of nonagenarians suffering from CLI, irrespective of the received treatment.
Methods
Selection
Between January 2012 and October 2015, all patients suffering from CLI were retrospectively reviewed in the Amphia hospital Breda, The Netherlands. CLI was classified according to the Rutherford classification. Rutherford classes 4 to 6 were included describing chronic rest pain, ulceration or gangrene of the lower extremities. Patients aged ≥90 years at admission were exclusively included. In the case of CLI occurring in both legs, only the most affected leg was included. Patients suffering from claudication and acute limb ischemia were excluded from this study.
Baseline characteristics
revascularisation options available. Conservative therapy consisted of optimal pharmacological treatment of pain, antibiotics, intensive wound care and minor amputations. Treatment of choice was determined by vascular surgeons and certified interventionists in a multidisciplinary vascular meeting.
Work‐up
Standard work‐up is used in our hospital to diagnose patients with symptoms of PAD. This includes measurement of ankle‐brachial index (ABI) and performing duplex or magnetic resonance angiography (MRA). Patients unsuitable for MRA underwent diagnostic angiography or computed tomography angiography (CTA). The Trans‐Atlantic Inter‐Society Consensus (TASC II) classification and open crural arteries were scored retrospectively to assess arterial lesions in the affected leg.16 In some of these elderly patients, the diagnosis of CLI was based on clinical symptoms without obtaining additional data.
Follow‐up
Endovascular treated patients underwent an ABI after 11 weeks, followed by consultation of a vascular surgeon. Patients were discharged from follow‐up when there were no signs of CLI during follow‐up. After bypass surgery, follow‐up included routine duplex ultrasound and ABI at 3 months, 6 months, 1 year, and 2 years after the initial procedure. Conservatively treated patients were preferably followed at the vascular outpatient clinic, but a standardized protocol was missing. The vascular surgeon decided the duration of follow‐up.
Outcome
Statistics
Statistical analysis was performed using SPSS 22.0 software (SPSS Inc. Chicago, IL, USA). Continuous variables with a Gaussian‐shaped distribution were summarized by mean and standard deviation, otherwise median and interquartile range were used. Survival probabilities were produced using the Kaplan‐Meier method. Mortality rates by age and gender were calculated as follows. For each year of age in the range 90‐99 years in our study group we counted the number of person‐years spent in that age across all patients during follow‐up, which number served as denominator. The number of patients who died at that age served as numerator. The resulting ratio is the age specific mortality rate in our study group. Actually it is an average mortality rate across the calendar years 2012‐2015. Actuarial survivor curves were calculated from the observed age and gender specific mortality rates. Life expectancy for either gender was calculated as the area under the survivor curve using the trapezoidal method of numerical integration. Confidence limits of life expectancy were calculated as the 2.5 and 97.5 centiles of the empirical distribution of calculated life expectancies across 1000 bootstrap samples. Mortality rate ratios with respect to the Dutch population were estimated as the number of observed deaths divided by the number of expected deaths. The latter number was obtained by applying the given total age and gender specific Dutch mortality rates of 2013 to the observed numbers of person‐years in our patient group.14 Statistical inference on the mortality rate ratios was based on the assumed Poisson distribution of the observed number of deaths.
Results
Table 2.1 Baseline characteristics.
Data are presented as n and (%), unless otherwise specified. IQR = interquartile range.
Table 2.2 describes the anatomic distribution of vascular disease in these nonagenarians. Eighteen (50%) patients had no significant aorto‐iliac lesion according to the TASC II‐classification. TASC II C or D femoral popliteal lesions were present in 18 (50%) patients. Crural pathology with a maximum of 1 open crural artery was present in at least 16 (44%) patients. No outflow information was available in 14 (39%) patients.
Table 2.5 Limb salvage. Total (n=36) 1‐month 33/36 (92%) 2‐months 33/36 (92%) 3‐months 33/36 (92%) 6‐months 32/36 (89%) 12‐months 32/36 (89%) 24‐months 32/36 (89%) 36‐months 32/36 (89%)
Table 2.6 shows the observed and expected number of deaths applying the Dutch mortality rates to our study group. The mortality rate ratio of the study group relatively to the Dutch population was 3.13 (95% CI: 2.00‐4.66; p<0.001). Life expectancy in years of the total Dutch population at age 90 in 2013 was 3.83 for males and 4.54 for females14 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. The latter life expectancies were calculated as the area under the actuarial survivor curves (Figures 2.1 and 2.2). The confidence limits were calculated using bootstrapping. Note that calculation of the survivor curve and hence life expectancy of males was based on only 5 deaths out of 9 patients. The mortality ratio relatively to the Dutch male population was 2.10 (95 % CI: 0.68‐4.89) and hence did not significantly differ from 1. Also life expectancy in males was not significantly different from that in the Dutch male population. This was in contrast to females with 19 deaths out of 27 patients. The mortality rate ratio relatively to the
Dutch female population was 3.60 (95 % CI: 2.16‐5.61) and hence was significantly different from 1. Also life expectancy in females differed significantly from that in the Dutch female population.
Table 2.6 Observed and expected number of deaths by applying the Dutch mortality rates to our study group by gender and age.
Gender age (yrs) obs. deaths person‐years Dutch rate exp. deaths Males 90 1 0.626 0.1842 0.115 91 0 1.997 0.2173 0.434 92 1 2.120 0.2516 0.533 93 1 2.602 0.2683 0.698 94 0 0.663 0.2998 0.199 95 1 0.821 0.3268 0.268 96 1 0.394 0.3508 0.138 97 0 0 0.4091 0.000 total 5 9.224 2.386 Females 90 0 2.049 0.1478 0.303 91 2 5.141 0.1634 0.840 92 6 7.183 0.1871 1.344 93 4 5.409 0.2139 1.157 94 2 2.697 0.2416 0.652 95 4 2.244 0.2620 0.588 96 1 1.066 0.3105 0.331 97 0 0.221 0.3188 0.070 total 19 26.010 5.285
Figure 2.2 Actuarial survivor curve at 90 years of age in female patients compared with that of the Dutch female population in 2013.
Discussion
Nonagenarians suffering from CLI are a small group of patients with a relatively low 1‐year survival rate of 36%. Life expectancy of this group of patients is reduced to 1.23 and 2.70 years, compared to a life expectancy of 3.83 and 4.54 years in the age matched Dutch population of males and females respectively.18 Taking this decreased longevity into account, therapy of choice should be taken on individual level and reticence towards invasive treatment of nonagenarians suffering from CLI appears to be necessary in selected patients. The treatment should particularly focus on the quality of life of these patients.
Survival of nonagenarians in vascular surgery
CLI is a severe disease in all age groups, but is related with higher mortality rates in elderly patients.19 This study also found CLI to be a severe disease with a high mortality for nonagenarians. There are several studies on safety and survival of nonagenarians undergoing vascular surgery, but only few address PAD. Overall the survival after vascular surgical procedures is fairly good with a one year survival of approximately
75%.10 Tough differences between vascular surgical procedures are described. One‐year survival rates in carefully selected nonagenarians undergoing endovascular repair of abdominal aorta aneurysm (EVAR) showed acceptable results varying between 83‐92%,20,21 whilst for post carotid reconstruction the 1‐year survival rate is 84%.22 In contrast, the survival in patients suffering from PAD is much worse. Hnath et al performed a study of nonagenarians who had undergone revascularisation of the lower extremity; describing a one‐year survival rate of 55%.7 Koskela et al. described the life expectancy in nonagenarians suffering from PAD as approximately 2 years irrespectively of the method of treatment.8 The evidence provided by these studies in addition to the current study suggests overall worse outcomes for patients suffering from PAD as opposed to those diagnosed with other vascular diseases.
Survival concerning CLI treatments
Only one study has both published survival rates among nonagenarians suffering from CLI and divided these rates into categories regarding therapy provided. Saarinen et al. retrospectively reviewed 233 nonagenarians suffering from either CLI (73%) or acute limb ischemia (27%), who had also received endovascular or surgical revascularisation. No significant difference was found for 1‐year survival rates in recipients of surgical therapy (51%) and endovascular therapy (49%). The same could be said for limb salvage rates when compared between these affected groups; surgical (85%) and endovascular (87%).5 The BASIL trial proved that it is unlikely that patient with a life expectancy of
less then 2 years will benefit from the superior long‐term results of bypass surgery.11 This may suggest a preference for the minimal invasive therapy of endovascular revascularisation, but patient related outcome measures such as quality of life were not presented.
Conservative treatment
Current research lacks data regarding conservative therapy when applied to the nonagenarians population. Thomas et al. described acceptable limb salvage rates of 84% after 2 years follow‐up in patients with a median age of 80 years old, who were deemed unsuitable for revascularisation.13 After a period of approximately 4 months wound healing occurred in 58% of the patients. This could be an acceptable therapy in nonagenarians with a short life expectancy, with low risk of adverse events when compared to the revascularisation options. However, further research into quality of life during this form of therapy must be performed in order to compile a clearer perspective of the expected outcomes.
This study is made notable by the high number of patients that underwent conservative therapy. One of the causes of this choice might be attributed to the anatomic lesion of these patients. Half of the patients had femoral‐popliteal TASC C en D lesions. Also 45% of the patients had only 1 crural outflow artery. These lesions make an endovascular approach to therapy less suitable and hence leading to diminished possibilities in these frail elderly. Due to high operative risk in nonagenarians, vascular surgeons might be expected to hold reservations toward the use of invasive bypass surgery. However, limb salvage reaching an acceptable rate of 89% in patients believed to be unsuitable for revascularisation, may prove this option to be satisfactory when compared to primary amputation.13 This limb salvage rate is even higher (94%) when the two primary amputations are excluded from this analysis. Another explanation of conservative therapy as therapy of choice is the individual decision of elderly patients for this therapy. There could be a significant percentage of patients in this group who no longer want to undergo invasive treatment due to QoL based concerns, therefore leaving conservative therapy as the only solution for these patients, with proven acceptable results.
Individual factors, such as life expectancy, functional status, arterial occlusive lesion and surgical risk should guide vascular surgeons in the choice of therapy in these frail patients.8 Perhaps vascular surgeons have to be reticent in performing invasive treatment due to low life expectancy in these frail nonagenarians. Results of conservative therapy seem to be acceptable, but more focus on quality of life is needed to be conclusive.
The small group of patients and the retrospective character of the study limit this study. Additional statistic analysis on differences between Fontaine 3 and 4 and differences in mortality rates between the treatment groups could not be performed. Due to the small group of male patients, not statistic significant difference in life expectancy of males could be demonstrated. Figure 2.1 suggests a trend towards a lower life expectancy in male patients suffering from CLI. Also the bootstrap confidence limits of life expectancy in male patients must be interpreted carefully as a relatively high frequency of calculated life expectancies across the bootstrap samples reached the lower limit of 0.5 years of the outcome space. More research in larger groups of patients is needed to investigate differences in subgroups on nonagenarians suffering from CLI.
in all nonagenarians probably because of the rationale of multiple medication use in fragile elderly patients. A selection bias may also have been present in the study due to the choice of therapy decided by the multidisciplinary vascular meeting. Despite these limitations in patient’s selection, we believe this study gives a representative view of our everyday clinic and evaluates the outcomes regarding the treatment of CLI.
Conclusion
References
1. Bosma J, Vahl A, Wisselink W. Systematic review on health‐related quality of life after revascularization and primary amputation in patients with critical limb ischemia. Ann Vasc Surg. 2013;27(8):1105‐14. 2. Nehler MR, Duval S, Diao L, Annex BH, Hiatt WR, Rogers K, et al. Epidemiology of peripheral arterial
disease and critical limb ischemia in an insured national population. J Vasc Surg. 2014;60(3):686‐95 e2. 3. Statistics. Prognose bevolking; geslacht, leeftijd, herkomst en generatie, 2015‐2060. CBS Statline. 2015. 4. Bohner H, Hummel TC, Habel U, Miller C, Reinbott S, Yang Q, et al. Predicting delirium after vascular
surgery: a model based on pre‐ and intraoperative data. Ann Surg. 2003;238(1):149‐56.
5. Saarinen E, Vuorisalo S, Kauhanen P, Alback A, Venermo M. The benefit of revascularization in nonagenarians with lower limb ischemia is limited by high mortality. Eur J Vasc Endovasc Surg. 2015; 49(4):420‐5.
6. Raats JW, van Hoof‐de Lepper CC, Feitsma MT, Meij JJ, Ho GH, Mulder PG, et al. Current factors of fragility and delirium in vascular surgery. Ann Vasc Surg. 2015;29(5):968‐76.
7. Hnath J, Roddy SP, Darling RC, 3rd, Paty PS, Taggert JB, Mehta M. Comparative results of open lower extremity revascularization in nonagenarians. J Vasc Surg. 2009;49(6):1459‐63; discussion 63‐4. 8. Koskela VK, Salenius J, Suominen V. Peripheral arterial disease in octogenarians and nonagenarians:
factors predicting survival. Ann Vasc Surg. 2011;25(2):169‐76.
9. Arvela E, Venermo M, Soderstrom M, Korhonen M, Halmesmaki K, Alback A, et al. Infrainguinal percutaneous transluminal angioplasty or bypass surgery in patients aged 80 years and older with critical leg ischaemia. Br J Surg. 2011;98(4):518‐26.
10. Wheatley BJ, Gorsuch JM, Mansour MA, Sage KA, Chambers CM, Cuff RF, et al. Vascular procedures in nonagenarians and centenarians are safe. Am J Surg. 2011;201(3):301‐4; discussion 4.
11. Bradbury AW, Adam DJ, Bell J, Forbes JF, Fowkes FG, Gillespie I, et al. Multicentre randomised controlled trial of the clinical and cost‐effectiveness of a bypass‐surgery‐first versus a balloon‐ angioplasty‐first revascularisation strategy for severe limb ischaemia due to infrainguinal disease. The Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial. Health Techn Assess. 2010; 14(14):1‐210, iii‐iv.
12. Adam DJ, Beard JD, Cleveland T, Bell J, Bradbury AW, Forbes JF, et al. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet. 2005; 366(9501):1925‐34.
13. Thomas AR, Raats JW, Lensvelt MM, de Groot HG, Veen EJ, van der Laan L. Conservative Treatment in Selected Patients with Severe Critical Limb Ischemia. World J Surg. 2015;39(8):2090‐5.
14. Statistics. http://statline.cbs.nl/Statweb/publication/?DM=SLNL&PA=37360ned&D1=a&D2=a&D3=a&D4= 63&HDR=G1%2cT&STB=G2%2cG3&VW=D. 2015.
15. Owens WD, Felts JA, Spitznagel EL, Jr. ASA physical status classifications: a study of consistency of ratings. Anesthesiology. 1978;49(4):239‐43.
16. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG, et al. Inter‐Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. 2007;45 Suppl S:S5‐67.
17. Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, et al. The Clavien‐Dindo classification of surgical complications: five‐year experience. Ann Surg. 2009;250(2):187‐96.
18. Statistics. Levensverwachting; geslacht en leeftijd, vanaf 1950 (per jaar). CBS Statline. 2015.
19. de Leur K, van Zeeland ML, Ho GH, de Groot HG, Veen EJ, van der Laan L. Treatment for critical lower limb ischemia in elderly patients. World J Surg. 2012;36(12):2937‐43.
20. Prenner SB, Turnbull IC, Serrao GW, Fishman E, Ellozy SH, Vouyouka AG, et al. Outcome of elective endovascular abdominal aortic aneurysm repair in nonagenarians. J Vasc Surg. 2011;54(2):287‐94. 21. Lee GK, Ullery BW, Lee JT. Elective EVAR in nonagenarians is safe in carefully selected patients. Ann
Vasc Surg. 2014;28(6):1402‐8.
22. Killeen KL, Wagner WH, Cossman DV, Cohen JL, Rao RK, Woo K. Carotid reconstruction in nonagenarians: is surgery a viable option? Ann Vasc Surg. 2008;22(2):190‐4.
Abstract
Introduction
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 to the non‐ affected 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 prior to admission by a geriatrician were included in this study. Baseline characteristics were retrieved from patients’ medical charts. Primary endpoint of this study is the mortality and the secondary endpoints include adverse events, re‐interventions 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.
Conclusion
Eight per cent 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.
Introduction
Critical limb ischemia (CLI) is a disease that is most prevalent in the elderly population. Symptoms of CLI include chronic rest pain and ulceration or gangrene of the lower extremities, the severity of which is characterised by a 50% mortality rate during the first 5 years of follow‐up.1,2 The group of patients suffering from CLI is expected to increase in the upcoming years as a result of the aging global population.2,3 Patients suffering from CLI are complex in the sense that they often suffer from one or more comorbidities such as coronary artery disease, renal impairment and diabetes mellitus.4‐6 This complexity can lead to circumstances in which half of these patients presenting at vascular units are unfit for surgical or endovascular revascularisation.7 This group of patients includes patients suffering from dementia.
Dementia is a neurological disease with a projected survival of 3‐12 years from diagnosis.8,9 The variation in survival rates depends on a number of factors such as time of diagnosis, age, and type of dementia. Mortality rates of dementia are 2‐4 times higher when compared to the non‐affected population, totally an estimated annual incidence of 4.6 million new cases worldwide and particularly common in the elderly.9,10 Risk factors for vascular diseases such as diabetes, smoking and hypertension are also risk factors for the development of dementia, further suggesting that the group of patients suffering from CLI in combination with dementia will grow in the upcoming years.8,11,12 However, dementia is frequently misdiagnosed in hospitalised patients, despite being an important parameter in the clinical decision making of vascular surgeons.13 Demented vascular patient are often deemed unfit for surgery and at risk of respiratory and cardiovascular adverse events.13
Methods
Selection
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. Some of the included patients were also included in a prior study about CLI. CLI was classified according to the Rutherford classification. Rutherford categories 4 to 6 were included, describing chronic rest pain, ulceration or gangrene of the lower extremities. Patients with diagnosed dementia prior to admission by a geriatrician were included in this study. All types of dementia were included, including Alzheimer disease, vascular dementia and fronto‐temporal dementia according to the DSM‐IV criteria. In cases of bilateral CLI, only data including the most affected leg was used for analysis.
Baseline characteristics
Baseline characteristics such as age, gender, Rutherford classification, diabetes, arterial hypertension and smoking status were retrieved from patients’ medical charts. Additionally comorbidities including cardiovascular disease, pulmonary disease, neurological disease (cerebrovascular accident or transient ischemic attack), renal impairment and malignancy were registered. Pre‐operative burden of comorbidity was scored according to the American Society of Anaesthesiologist scoring system (ASA).16
Treatment
Treatment methods were divided into 4 groups; endovascular revascularization, surgical revascularization, primary amputation and conservative therapy. Endovascular revascularization was defined as all minimal invasive endovascular procedures with and without use of intraluminal stents. Surgical revascularization was defined as all invasive treatments to gain peripheral blood flow including hybrid procedures. Amputation was defined as surgery with a primary amputation above the ankle joint. Conservative therapy consisted of optimal pharmacological treatment of pain, antibiotics, intensive wound care and minor amputations.14 Treatment of choice was determined by vascular surgeons and certified interventionists in a multidisciplinary vascular meeting.
Work‐up
magnetic resonance angiography (MRA). Patients unsuitable for MRA underwent diagnostic angiography or computed tomography angiography (CTA). The Trans‐Atlantic Inter‐Society Consensus (TASC II) classification and open crural arteries were scored retrospectively to assess anatomical arterial lesions in the affected leg.17 In some of these patients, the diagnosis of CLI was based on clinical symptoms. No obtaining additional data was gathered due to the lack of clinical consequences.
Outcome
The main outcome result of this study is the mortality of these demented patients. Date of death was confirmed using the Dutch national death registry database (CompeT&T Eindhoven). Secondary endpoints were adverse events, re‐interventions and limb salvage. Adverse events were scored according to the Clavien‐Dindo classification for surgical complications and were recorded during hospitalization and the first 30 days after discharge.18 Re‐interventions of the affected leg and limb salvage, defined as survival without major amputation above the ankle, were assessed during follow‐up.
Statistics
Statistical analysis was performed with SPSS 22.0 software (SPSS Inc. Chicago, IL, USA). Kolmogorov‐Smirnov tests were performed at continuous data. Gaussian‐shaped distribution were analyzed using the Student t‐test and expressed as mean and standard deviation, while non‐normally distributed data were analyzed using the Mann‐ Whitney U‐test, expressed as median and interquartile range. For categorical variables, chi‐squared and Fisher’s exact tests were used. Survival rates were produced using Kaplan‐Meier survival curves.
Results
at admission. Distribution of the used treatment, comorbidities and risk factors are shown in Table 3.1. Table 3.1 Baseline characteristics. N=31 Male 18 (58%) Mean age (SD) 82 (6) Rutherford 4 4 (13%) Rutherford 5‐6 27 (87%) Median hospital stay in days (IQR) 12 (10) Treatment Endovascular 7 (23%) Surgical 3 (10%) Primary amputation 2 (6%) Conservative 19 (61%) Comorbidity Cardiac 20 (65%) Pulmonary 8 (26%) Neurological 5 (16%) Malignancy 1 (3%) ASA 2 2 (6%) 3 24 (77%) 4 5 (16%) Risk‐factors Hypertension 19 (61%) Diabetes 17 (55%) Renal impairment 6 (19%) Current smoking 9 (29%) Data are presented as n and (%), unless otherwise specified. SD= standard deviation; IQR=interquartile range.
Table 3.2 shows the outcome rates and adverse events. The mean follow‐up was estimated at 13 months. Adverse events occurred in 53% of the patients, with 37% delirium in this study population. The distribution of the anatomic arterial lesions is presented in Table 3.3 according to the TASC II‐classification. Information about the anatomical lesions was lacking in 29% of the patients.
therapy may be an acceptable therapy option. As a result of this, pre‐operative identification of these patients seems to be valuable in the clinical decision‐making. Survival rates in demented patients vary from 3 to 12 years depending on the time of diagnosis. The onset of dementia determinates the life expectancy with a longer life expectancy in patients diagnosed before 75 years old.8 Till 50% of the population above 85 years old is affected by dementia.10 Nilsson et al described a group of 945 demented patients with an average age of 80 years old who exhibited an average survival period of 35 months.19
An additional factor concerning the current study is the mortality rate of elderly suffering CLI. Results in this area are varied and depend upon the treatment method used as well as the age of the patients. De Leur et al described a 1‐year mortality rate of 33%, increasing to 44% after 2 years in patients above 80 years old in a study which utilised all possible treatment methods for CLI.20 Mortality rates following vascular surgery are associated with >50% mortality at one year in patients above 80 years old.5 This information suggest that elderly patients can be considered frail and at high risk when undergoing surgical procedures.
By combining the results of demented patients with the survival rates of elderly patients suffering from CLI, we can begin to map the frailty of demented patients suffering from CLI. The one‐year mortality rate of 52% within our population is higher compared to the CLI patients described by de Leur et al. Advanced age is already a well‐ known risk factor for patients undergoing surgery, however dementia seems to present as an additional, independent risk factor concerning increased mortality.13,21 It seems to be valuable to identify these patients preoperatively. Because of the high mortality rates in these demented patients, outcome measures such as quality of life seems to be more important to guide in clinical decision‐making.
Conclusion
References
1. Spincemaille GH, Klomp HM, Steyerberg EW, Habbema JD. Pain and quality of life in patients with critical limb ischaemia: results of a randomized controlled multicentre study on the effect of spinal cord stimulation. ESES study group. Eur J Pain. 2000;4:173‐84.
2. Nehler MR, Duval S, Diao L, Annex BH, Hiatt WR, Rogers K, et al. Epidemiology of peripheral arterial disease and critical limb ischemia in an insured national population. J Vasc Surg. 2014;60:686‐95 e2. 3. Bosma J, Vahl A, Wisselink W. Systematic review on health‐related quality of life after revascularization
and primary amputation in patients with critical limb ischemia. Ann Vasc Surg. 2013;27:1105‐14. 4. Klevsgard R, Risberg BO, Thomsen MB, Hallberg IR. A 1‐year follow‐up quality of life study after
hemodynamically successful or unsuccessful surgical revascularization of lower limb ischemia. J Vasc Surg. 2001;33:114‐22.
5. Bradbury AW, Adam DJ, Bell J, Forbes JF, Fowkes FG, Gillespie I, et al. Multicentre randomised controlled trial of the clinical and cost‐effectiveness of a bypass‐surgery‐first versus a balloon‐ angioplasty‐first revascularisation strategy for severe limb ischaemia due to infrainguinal disease. The Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial. Health Techn Assess. 2010;14: 1‐210, iii‐iv.
6. Raats JW, van Hoof‐de Lepper CC, Feitsma MT, Meij JJ, Ho GH, Mulder PG, et al. Current factors of fragility and delirium in vascular surgery. Ann Vasc Surg. 2015;29:968‐76.
7. Adam DJ, Beard JD, Cleveland T, Bell J, Bradbury AW, Forbes JF, et al. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet. 2005;366: 1925‐34. 8. Kua EH, Ho E, Tan HH, Tsoi C, Thng C, Mahendran R. The natural history of dementia. Psychogeriatrics. 2014;14:196‐201. 9. Ientile L, De Pasquale R, Monacelli F, Odetti P, Traverso N, Cammarata S, et al. Survival rate in patients affected by dementia followed by memory clinics (UVA) in Italy. J Alzheimers Dis. 2013;36:303‐9. 10. Gonzalez‐Velez AE, Forjaz MJ, Giraldez‐Garcia C, Martin‐Garcia S, Martinez‐Martin P, Spanish Research Group on Quality of L, et al. Quality of life by proxy and mortality in institutionalized older adults with dementia. Geriatr Gerontol Int. 2015;15:38‐44.
11. Skoog I, Kalaria RN, Breteler MM. Vascular factors and Alzheimer disease. Alzheimer Dis Assoc Dis. 1999;13 Suppl 3:S106‐14.
12. Vinkers DJ, Stek ML, van der Mast RC, de Craen AJ, Le Cessie S, Jolles J, et al. Generalized atherosclerosis, cognitive decline, and depressive symptoms in old age. Neurology. 2005;65:107‐12. 13. Shen HN, Lu CL, Li CY. Dementia increases the risks of acute organ dysfunction, severe sepsis and
mortality in hospitalized older patients: a national population‐based study. PloS One. 2012;7:e42751. 14. Thomas AR, Raats JW, Lensvelt MM, de Groot HG, Veen EJ, van der Laan L. Conservative Treatment in
Selected Patients with Severe Critical Limb Ischemia. World J Surg. 2015;39:2090‐5.
15. Taylor SM, Kalbaugh CA, Blackhurst DW, Kellicut DC, Langan EM, 3rd, Youkey JR. A comparison of percutaneous transluminal angioplasty versus amputation for critical limb ischemia in patients unsuitable for open surgery. J Vasc Surg. 2007;45:304‐10; discussion 10‐1.
16. Owens WD, Felts JA, Spitznagel EL, Jr. ASA physical status classifications: a study of consistency of ratings. Anesthesiology. 1978;49:239‐43.
17. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG, et al. Inter‐Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. 2007;45 Suppl S:S5‐67.
18. Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, et al. The Clavien‐Dindo classification of surgical complications: five‐year experience. Ann Surg. 2009;250:187‐96.
19. Nilsson K, Gustafson L, Hultberg B. Survival in a large elderly population of patients with dementia and other forms of psychogeriatric diseases. Dement Geriatr Cogn Disord. 2011;32:342‐50.
21. Saarinen E, Vuorisalo S, Kauhanen P, Alback A, Venermo M. The benefit of revascularization in nonagenarians with lower limb ischemia is limited by high mortality. Eur J Vasc Endovasc Surg. 2015; 49:420‐5.
22. Nederland A. Neemt het aantal mensen met dementie toe of af? 2014.
23. Chisci E, Perulli A, Iacoponi F, Setacci F, de Donato G, Palasciano G, et al. Benefit of revascularisation to critical limb ischaemia patients evaluated by a patient‐oriented scoring system. Eur J Vasc Endovasc Surg. 2012;43:540‐7.
24. (TASC) TI‐sc. Management of peripheral arterial disease (PAD). Eur J Vasc Endovasc Surg. 2000;19 (Suppl.A):144‐243.
Abstract
Objective
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 endpoint 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 months 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 health status (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 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 four treatment modalities can raise HS in the short and the long‐term, however endovascular and surgical revascularization seem to positively effect HS the most. QoL results are lacking in both the short‐ and long‐term.
Conclusion
Introduction
Peripheral arterial disease (PAD) has become an increasing problem due to the aging population of the Western world with a prevalence of 10‐14%.1‐3 The disease is most severe when presented as critical limb ischemia (CLI),4 the symptoms of which include chronic rest pain and ulceration or gangrene of the low extremities. The severity of the problem is evidenced by an incidence of 0.35% in the United States and 50% mortality rate during the first 5 years of follow‐up.3,5 Patients suffering from CLI are complex in the sense that they often suffer from one or more comorbidities such as coronary artery disease, cerebrovascular disease and diabetes mellitus.6,7 Treatment options consist of endovascular procedures, surgical revascularization, primary amputation or conservative therapy. These generally focus on relieve of ischemic pain, healing ischemic ulcers, providing limb salvage and prolonged survival. An endovascular approach is the first treatment for patients suffering from claudication; however evidence concerning ideal treatment for patients suffering from CLI is lacking.8 According to the BASIL‐trial, the decision whether or not to perform percutaneous transluminal angioplasty (PTA) or bypass surgery in patients with infra‐inguinal disease depends on patients’ life expectancy. Patients expected to live longer than two years should be offered bypass surgery. In contrast, for patients with a life expectancy shorter than 2 years, PTA is the preferred treatment since these patients are unlikely to enjoy the long‐term results of bypass surgery. Unfortunately, about one‐third of CLI patients are deemed unfit for open or endovascular treatment due to comorbidities.7
developed based upon variables which health professionals thought to be relevant. However these fail to take into account the subjective value of QoL. QoL and HS are both commonly used patient reported outcome measures and an overview of the commonly used questionnaires is shown in Table 4.1.
Determining the best possible treatment for the growing group of patients suffering from CLI will become a challenge throughout the upcoming years.10 HS is lower in patients suffering from CLI compared to control group patients, hence increasing QoL and HS is a valuable outcome.7,11 The aim of this systematic review is to explore the best clinical decision making to increase QoL in CLI patients.
Table 4.1 Health status and Quality of life measurements.
Questionnaire Measurement Reference
SF‐36 / SF‐8 Health status Hamming and de Vries28
RAND‐36 Health status Hamming and de Vries / Breek et al.28,29
Euro‐QoL Health status Hamming and de Vries28
VascuQoL Health status Frans et al.31
NHP Health status Hamming and de Vries28 Q‐TWIST ‐ Sultan et al.26 Spitzer QL‐index ‐ Albers et al.21 Method of Rosser ‐ Humphrey et al.22 WHOQol‐100 Quality of life Hamming and de Vries28
SEIQoL Quality of life Hamming and de Vries28
