Functional outcome of critical limb ischemia
2007; Elsevier BV; Volume: 45; Issue: 6 Linguagem: Inglês
10.1016/j.jvs.2007.02.052
ISSN1097-6809
Autores Tópico(s)Cerebrovascular and Carotid Artery Diseases
ResumoResults of treatment for critical limb ischemia have traditionally focused on physician-oriented end points related to limb salvage surgery. Although numerous studies have demonstrated excellent patency and limb salvage after surgical revascularization procedures, survival in this patient population is poor, comorbidities reducing quality of life are rampant, and recovery from limb salvage surgery can be prolonged and complicated despite “success” as defined by traditional reporting methods. Patient-oriented outcome end points, such as health- related quality of life and functional status, are essential in defining optimal treatment options for the population of patients with critical limb ischemia. This area of research remains in its infancy, but will become increasingly important as the population of patients with critical limb ischemia and treatment options for these patients continue to expand. The current status and future outlook of functional and quality of life assessment of patients with critical limb ischemia is reviewed. Results of treatment for critical limb ischemia have traditionally focused on physician-oriented end points related to limb salvage surgery. Although numerous studies have demonstrated excellent patency and limb salvage after surgical revascularization procedures, survival in this patient population is poor, comorbidities reducing quality of life are rampant, and recovery from limb salvage surgery can be prolonged and complicated despite “success” as defined by traditional reporting methods. Patient-oriented outcome end points, such as health- related quality of life and functional status, are essential in defining optimal treatment options for the population of patients with critical limb ischemia. This area of research remains in its infancy, but will become increasingly important as the population of patients with critical limb ischemia and treatment options for these patients continue to expand. The current status and future outlook of functional and quality of life assessment of patients with critical limb ischemia is reviewed. It is increasingly recognized that traditional methods of assessing outcomes and quality of care in patients with critical limb ischemia (CLI) do not fully address the broad range of concerns in these patients. The physician-oriented view of success has traditionally focused on graft patency, limb salvage, and survival.1Rutherford R.B. Baker J.D. Ernst C. Johnston K.W. Porter J.M. Ahn S. et al.Recommended standards for reports dealing with lower extremity ischemia: revised version.J Vasc Surg. 1997; 26: 517-538Abstract Full Text Full Text PDF PubMed Scopus (2692) Google Scholar It is a testimony to the skills of surgeons involved in the treatment of patients with CLI that consistently excellent results have been reported for these variables for many years. Overall patency rates at 5 years of 60% to 80% for lower extremity arterial reconstructions, with limb salvage rates of 70% to 90%, have been consistently reported.2Dalman R.L. Taylor L.M. Infrainguinal revascularization procedures Compiled from Annals of Vascular Surgery.in: Porter J.M. Taylor L.M. Basic data underlying clinical decision making in vascular surgery. Quality Medical Publishing, Inc, St Louis1994: 141-143Google Scholar However, the relatively poor 5-year survival of the patient group with CLI, typically about ≤50%,3Feinglass J. Pearce W.H. Martin G.J. Gibbs J. Cowper D. Sorensen M. et al.Postoperative and amputation-free survival outcomes after femorodistal bypass grafting surgery: findings from the Department of Veterans Affairs National Surgical Quality Improvement Program.J Vasc Surg. 2001; 34: 283-290Abstract Full Text Full Text PDF PubMed Scopus (73) Google Scholar, 4Pomposelli F.B. Marcaccio E.J. Gibbons G.W. Campbell D.R. Freeman D.V. Burgess A.M. et al.Dorsalis pedis arterial bypass: durable limb salvage for foot ischemia in patients with diabetes mellitus.J Vasc Surg. 1995; 21: 375-384Abstract Full Text Full Text PDF PubMed Scopus (219) Google Scholar, 5Taylor L.M. Hamre D. Dalman R.L. Porter J.M. Limb salvage vs. amputation for critical ischemia The role of vascular surgery.Arch Surg. 1995; 126: 1251-1257Crossref Scopus (99) Google Scholar, 6Kalra M. Gloviczki P. Bower T.C. Panneton J.M. Harmsen W.S. Jenkins G.D. et al.Limb salvage after successful pedal bypass grafting is associated with improved long term survival.J Vasc Surg. 2001; 33: 6-16Abstract Full Text Full Text PDF PubMed Scopus (110) Google Scholar, 7The ICAI GroupThe Study Group of Critical Chronic Ischemia of the Lower ExtremitiesLong-term mortality and its predictors in patients with critical leg ischaemia.Eur J Vasc Endovasc Surg. 1997; 14 (Anonymous): 91-95Abstract Full Text PDF PubMed Scopus (101) Google Scholar, 8Nehler M.R. Moneta G.L. Edwards J.M. Yeager R.A. Taylor L.M. Porter J.M. Surgery for chronic lower extremity ischemia in patients eighty or more years of age: operative results and assessment of postoperative independence.J Vasc Surg. 1993; 18: 618-624Abstract Full Text Full Text PDF PubMed Scopus (60) Google Scholar underscores the fragile nature of this patient group, one typically associated with overall poor health with multiple comorbidities. The technical feasibility of limb salvage surgery is axiomatic, and the endovascular revolution is rapidly expanding the repertoire of invasive therapy available to patients with CLI. To add to this “perfect storm,” the general aging of the population, persistently high smoking rates (20.9% of the United States adult population in 1995),9Centers for Disease Control and Prevention (CDC)Tobacco use among adults--United States, 2005.MMWR Morb Mortal Wkly Rep. 2006; 55: 1145-1148PubMed Google Scholar and the rapid increase of other cardiovascular risk factors, such as diabetes, obesity, and renal failure, virtually assures a steady growth of the population at risk and seeking treatment for CLI. Overall quality of life is improving in elderly patients,10Liao Y. McGee D.I. Cao G. Cooper R.S. Quality of the last year of life of older adults: 1986 vs. 1993.JAMA. 2000; 283: 512-518Crossref PubMed Scopus (69) Google Scholar but patients with peripheral arterial disease have a significantly worse quality of life than their counterparts without peripheral arterial disease. Although technical proficiency in performing invasive revascularization and in maintaining limb salvage can certainly be attained, it is clearly recognized, at least anecdotally, that limb salvage surgery takes a significant toll on patients. In contrast to the well-developed body of publications on surgical outcomes, the current status of research in patient-oriented outcomes remains in its infancy. This has been identified as a “critical issue” by the TransAtlantic Intersociety Consensus, an international consortium of physicians involved in the management of peripheral arterial disease, who stated “Currently there are no quality-of-life instruments that have been standardized in a large population of patients requiring treatment for critical limb ischemia …. Improvement in functional status is often difficult to define in patients with critical limb ischemia because of the presence of numerous and often severe comorbid conditions. Simple assessment of walking distance, though useful in some patients, does not apply to many. … Therefore, specific instruments capable of detecting improvement in functional status in this diverse patient population must be developed.”11Management of peripheral arterial disease (PAD): TransAtlantic Inter-Society Consensus (TASC).J Vasc Surg. 2000; 31 (Anonymous): S190Abstract Full Text Full Text PDF PubMed Scopus (60) Google Scholar This review will discuss the available body of literature on patient-oriented outcomes research in the treatment of patients with CLI. In an attempt to evaluate outcomes of CLI from a patient-oriented point of view, a number of retrospective studies have been performed to assess patient function outside of the hospital setting. The retrospective nature of these studies inevitably limits their scope; in general, the outcomes measured have included maintenance of ambulatory and independent living status. One of the earliest reports to evaluate patient-oriented functional outcomes was published by Abou-Zamzam et al12Abou-Zamzam A.M. Lee R.W. Moneta G.L. Taylor L.M. Porter J.M. Functional outcome after infrainguinal bypass for limb salvage.J Vasc Surg. 1997; 25: 287-297Abstract Full Text Full Text PDF PubMed Scopus (102) Google Scholar from the Oregon Health & Sciences University. Preoperative and postoperative living situation and ambulatory status were evaluated in 513 patients undergoing lower extremity bypass from 1980 to 1995. Ambulatory and living status before surgery for CLI and 6 months after surgery are summarized in Table I. At 6 months, 99% of patients who were living independently preoperatively had maintained independent living status and 97% of patients who were ambulatory preoperatively remained ambulatory. Conversely, very few people who were in a dependent living situation preoperatively went on to live independently at 6 months (4%), and only 21% of patients who did not ambulate independently preoperatively were independently ambulatory at 6 months.Table IFunctional status of surviving patients before surgery and 6 months after surgical revascularization for critical limb ischemia⁎Adapted from Abou-Zamzam et al12 with permission of the authors.Before surgery6 months after surgery, %Living situationIndependentDependentIndependent991.4Dependent496Ambulatory statusAmbulatoryNonambulatoryAmbulatory973Nonambulatory2179 Adapted from Abou-Zamzam et al12Abou-Zamzam A.M. Lee R.W. Moneta G.L. Taylor L.M. Porter J.M. Functional outcome after infrainguinal bypass for limb salvage.J Vasc Surg. 1997; 25: 287-297Abstract Full Text Full Text PDF PubMed Scopus (102) Google Scholar with permission of the authors. Open table in a new tab Multivariate analysis confirmed the importance of preoperative living situation and ambulatory status in predicting outcome at 6 months (P < .0001). Amputation (P < .0001) and loss of primary patency (P = .025) were predictive of poor ambulatory status at 6 months. Other reports also demonstrated that ambulatory and living status were maintained after surgical revascularization for CLI.13Pomposelli F.B. Arora S. Gibbons G.W. Frykberg R. Smakowski P. Campbell D.R. et al.Lower extremity arterial reconstruction in the very elderly: successful outcome preserves not only the limb but also residential status and ambulatory function.J Vasc Surg. 1998; 28: 215-225Abstract Full Text Full Text PDF PubMed Scopus (113) Google Scholar, 14Seabrook G.R. Cambria R.A. Freischlag J.A. Towne J.B. Health-related quality of life and functional outcome following arterial reconstruction for limb salvage.Cardiovasc Surg. 1999; 7: 279-286Crossref PubMed Scopus (33) Google Scholar, 15Holtzman J. Caldwell M. Walvatne C. Kane R. Long-term functional status and quality of life after lower extremity revascularization.J Vasc Surg. 1999; 29: 395-402Abstract Full Text Full Text PDF PubMed Scopus (47) Google Scholar Although 6-month functional outcome appeared favorable, it was the impression of the investigators that patients undergoing surgery for CLI had a frequent, ongoing need for care of their extremity, with prolonged periods of wound healing and subsequent operations to maintain graft patency. The authors defined an “ideal” outcome of lower extremity surgery for critical limb ischemia as a single operation with prompt wound healing, no perioperative complications, and no need for further lower extremity interventions. The records of 112 consecutive patients undergoing surgery for critical limb ischemia followed up for 5 to 7 years were reviewed for operative complications, graft patency, limb salvage, survival, living and ambulatory status, time to achieve wound healing (both operative and ischemic), need for repeat operations and recurrence of ischemia.16Nicoloff A.D. Taylor L.M. McLafferty R.B. Moneta G.L. Porter J.M. Patient recovery after infrainguinal bypass grafting for limb salvage.J Vasc Surg. 1998; 27: 256-266Abstract Full Text Full Text PDF PubMed Scopus (157) Google Scholar Mean follow-up was 42 months. Ambulatory and living status are presented in Table II. In contrast with the prior study in which patients were monitored for 6 months, with longer follow-up there is a greater decline in independent ambulation and living status. Healing of all wounds, both operative and ischemic, required a mean of 4.2 months, and completed wound healing had not been achieved in 25 patients (22%) at the time of the last follow-up or death.Table IIAmbulatory and living status of 112 patients before and after limb salvage surgery⁎Adapted from Abou-Zamzam et al12 with permission of authors.StatusAt last follow-up or death, %Pre-op, %Post-op, %Living independently88 (99/112)66 (66/99)73 (72/99)Ambulatory92 (103/112)84 (87/103)70 (72/103)Living independently and ambulatory86 (96/112)56 (54/96)68 (65/96) Adapted from Abou-Zamzam et al12Abou-Zamzam A.M. Lee R.W. Moneta G.L. Taylor L.M. Porter J.M. Functional outcome after infrainguinal bypass for limb salvage.J Vasc Surg. 1997; 25: 287-297Abstract Full Text Full Text PDF PubMed Scopus (102) Google Scholar with permission of authors. Open table in a new tab Repeat operations to maintain graft patency, treat wound complications, or treat recurrent or contralateral ischemia were required in 61 patients (54%, mean 1.6 reoperations per patient). Major amputation of the index or contralateral extremity was ultimately required in 26 patients. Types of reoperative procedures are listed in Table III.Table IIIRepeat operations in 61 patients undergoing limb salvage surgery for critical limb ischemia⁎Adapted from Nicoloff et al16 with permission of authors.Type of repeat operationTotal number (%)Wound débridement32 (18)Major amputation26 (15)Minor amputation26 (15)Skin graft3 (2)New bypass graft construction42 (24)Bypass graft revision32 (18)Inflow procedure15 (9) Adapted from Nicoloff et al16Nicoloff A.D. Taylor L.M. McLafferty R.B. Moneta G.L. Porter J.M. Patient recovery after infrainguinal bypass grafting for limb salvage.J Vasc Surg. 1998; 27: 256-266Abstract Full Text Full Text PDF PubMed Scopus (157) Google Scholar with permission of authors. Open table in a new tab As assessed by the objective of the “ideal” outcome, optimal results of revascularization for CLI occurred infrequently. Only 14% of patients had an uncomplicated operation, relief of symptoms, complete wound healing, no need for repeat operation, and maintenance of functional status. For the 86% of patients who did not have an ideal result, wound care, repeat hospitalizations and repeat surgery, frequent clinic visits, and declining functional status meant that a major portion of their remaining life was spent with ongoing treatment for CLI. Methods used in the previous study were used to evaluate functional outcomes after lower extremity vein graft revisions vs primary operations.17Landry G.J. Moneta G.L. Taylor Jr, L.M. Edwards J.M. Yeager R.A. Comparison of procedural outcomes after lower extremity reversed vein grafting and secondary surgical revision.J Vasc Surg. 2003; 38: 22-28Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar This study was done to question the hypothesis that lower extremity vein graft revisions were well-tolerated procedures with minimal morbidity. The results of 137 patients undergoing primary lower extremity bypasses were compared with their results after revision. As expected, operative revisions were associated with less morbidity than initial procedures; however, complication rates were still high with revisions, with an overall complication rate 36% after the initial operation vs 22% after revision (P = .015). Return to normal preoperative ambulatory status at discharge occurred in 71% of patients after primary operations vs 92% after revisions (P < .001). Return to independent living status at the time of discharge was 66% after the primary operation and 80% after revision (P < .01). At 6 months >90% of patients had returned to their preoperative living and ambulatory status after both initial operations and revisions. Taylor et al18Taylor S.M. Kalbaugh C.A. Blackhurst D.W. Cass A.L. Trent E.A. Langan E.M. et al.Determinants of functional outcome after revascularization for critical limb ischemia: an analysis of 1000 consecutive vascular interventions.J Vasc Surg. 2006; 44: 747-756Abstract Full Text Full Text PDF PubMed Scopus (131) Google Scholar retrospectively evaluated similar functional outcomes at 5 years in 1000 patients undergoing surgical revascularization for CLI. Ambulatory and living status were evaluated in addition to the traditional outcome measures of graft patency, limb salvage, and survival. Not surprisingly, 5-year overall graft patency (72.4%) and limb salvage (72.1%) were excellent, with predictably lower 5-year survival (41.9%) in this patient group. Independent ambulatory (70.6%) and living status (81.3%) was well maintained, with impaired ambulatory status at presentation and dementia predictive of poor functional outcomes. Limb loss was also associated with poor functional outcomes. The anatomic location and type of reconstruction did not predict functional outcomes, nor did other associated comorbidities such as age, diabetes, history of coronary artery disease, or renal failure, among others. Additional evidence in support of the inadequacy of traditional reporting standards to fully address the impact of limb salvage surgery on patients’ overall health were addressed independently by the vascular surgery groups from the University of Arizona,19Goshima K.R. Mill J.L. Hughes J.D. A new look at outcomes after infrainguinal bypass surgery: traditional reporting standards systematically underestimate the expenditure of effort required to attain limb salvage.J Vasc Surg. 2004; 39: 330-335Abstract Full Text Full Text PDF PubMed Scopus (149) Google Scholar and the University of Colorado and Southern Illinois University.20Chung J. Bartelson B.B. Hiatt W.R. Peyton B.D. McLafferty R.B. Hopley C.W. et al.Wound healing and functional outcomes after infrainguinal bypass with reversed saphenous vein for critical limb ischemia.J Vasc Surg. 2006; 43: 1183-1190Abstract Full Text Full Text PDF PubMed Scopus (86) Google Scholar In the former study, 318 patients undergoing lower extremity revascularization, 72% of which were for CLI, were retrospectively analyzed for need for hospital readmissions and repeat operations and wound healing. In the CLI patient group, approximately 50% of patients required at least one reoperation ≤3 months and at least one hospital readmission ≤6 months. More than half of the patients required at least 3 months for complete healing of surgical or ischemic wounds. Multivariate analysis revealed tissue loss, renal failure, diabetes, and minority status as independent factors predicting adverse outcomes. In the latter study, 334 patients at the two institutions undergoing revascularization for CLI were assessed for wound healing as well as ambulatory and living status. Complete wound healing was achieved in only 42% at 6 months and 75% at 1 year. Independent ambulatory status decreased from 91% at baseline to 72% at 6 months, but independent living status decreased from 96% to 91% during the same time period, implying that although living status can be maintained, ambulatory status, perhaps a better surrogate of overall health, is subjected to a greater degree of decline. The above studies are important in terms of realigning traditional methods of reporting outcomes in CLI. As noted, they are limited by their retrospective nature, and perhaps more important, by their relatively limited scope in assessing functional outcome. Few would argue against the notion that independent ambulatory and living status are good things; however, they do not really tell the whole story. For instance:•Does the distance one can ambulate independently affect quality of life?•Does someone who can walk independently automatically have a better quality of life than one who requires assistance?•Can quality of life be achieved in an assisted living environment, perhaps to an even better degree than someone living independently but without a developed support structure?•Do other comorbidities affect function and quality of life to an even greater degree than a patients’ vascular status? These and other important questions have been addressed in numerous recent studies using general and disease-specific quality-of-life questionnaires. Prospective data are conspicuously lacking in the assessment of outcomes of CLI. The prospective data that are available are primarily studies involving patient questionnaires. Patient assessment of quality of life is an important element of functional outcome assessment that has been inconsistently defined in patients undergoing interventions for CLI. General questionnaires that address components of overall well-being and disease specific questionnaires that focus on more directly relevant domains have been used to evaluate patients with peripheral arterial disease. Of the generalized questionnaires, the Short Form 36 (SF36) and Nottingham Health Profile (NHP) have been most widely used in patients with peripheral arterial disease and serve as an assessment of global health status. The SF36 addresses eight health concepts: physical function, role limitation due to physical problems, bodily pain, general health perception, social function, emotional well-being, and role limitation due to emotional problems. The NHP covers six types of experience that may be affected by illness: pain, physical mobility, sleep, emotional reactions, energy, and social isolation.21Litwin M.S. Health-related quality of life.in: Penson D.F. Wei J.T. Clinical research methods for surgeons. Human Press, Totowa, NJ2006: 237-253Google Scholar Generalized questionnaires are advantageous in assessing overall quality of life and are applicable across multiple disease states. The disadvantage of generic questionnaires is that they are less able to detect small changes related to treatment of specific disease states.22deVries M. Ouwendijk R. Kessels A.G. deHaan M.W. Flobbe K. Hunink M.G.M. et al.Comparison of generic and disease-specific questionnaires for the assessment of quality of life in patients with peripheral arterial disease.J Vasc Surg. 2005; 41: 261-268Abstract Full Text Full Text PDF PubMed Scopus (115) Google Scholar Although there is no consensus on which generic quality-of-life questionnaire is most appropriate in patients with CLI, a recent study from Sweden found the NHP to be more responsive to change in patients with CLI.23Wann-Hansson C. Hallberg I.R. Risberg B. Klevsgard R. A comparison of the Nottingham Health Profile and the Short Form 36 Health Survey in patients with chronic lower limb ischaemia in a longitudinal perspective.Health Qual Life Outcomes. 2004; 2: 9-20Crossref PubMed Scopus (65) Google Scholar Disease-specific questionnaires are theoretically more responsive to subtle effects after treatment. The Peripheral Arterial Disease-Walking Impairment Questionnaire, developed by Regensteiner et al,24Regensteiner J.G. Steiner J.F. Panzer R.J. Hiatt W.R. Evaluation of walking impairment by questionnaire in patients with peripheral arterial disease.J Vasc Med Biol. 1990; 2: 142-152Google Scholar is a disease-specific questionnaire that has previously been validated in patients with intermittent claudication. A similar questionnaire for CLI has not been developed. The Vascular Quality of Life Questionnaire (VascuQol) was designed as a disease-specific questionnaire for patients with peripheral arterial disease, and is generally felt to be more applicable to patients with CLI. The questionnaire contains 25 questions in 5 domains (pain, symptoms, activities, social, and emotional), with each question graded on a 7-point scale ranging from 1 (worst) to 7 (best).25Morgan M.B.F. Crayford T. Murrin B. Fraser S.C.A. Developing the vascular quality of life questionnaire: a new disease-specific quality of life measure for use in lower limb ischemia.J Vasc Surg. 2001; 33: 679-687Abstract Full Text Full Text PDF PubMed Scopus (189) Google Scholar A link between depressed mood and peripheral arterial disease has been suggested. Cross-sectional studies using a short form of the Geriatric Depression Scale26Arseven A. Guralnik J.M. O’Brien E. Liu K. McDermott M.M. Peripheral arterial disease and depressed mood in older men and women.Vasc Med. 2001; 6: 229-234Crossref PubMed Scopus (47) Google Scholar, 27McDermott M.M. Greenland P. Guralnik J.M. Liu K. Criqui M.H. Pearce W.H. et al.Depressive symptoms and lower extremity functioning in men and women with peripheral arterial disease.J Gen Intern Med. 2003; 18: 461-467Crossref PubMed Scopus (90) Google Scholar, 28Lyness J. Noel T.K. Cox C. King D.A. Conwell Y. Caine E.D. Screening for depression in elderly primary care patients: a comparison of the Center for Epidemiologic Studies-Depression Scale and the Geriatric Depression Scale.Arch Intern Med. 1997; 157: 449-454Crossref PubMed Google Scholar have confirmed increased depression among elderly patients with peripheral arterial disease compared with those without peripheral arterial disease. It is not known if depression symptoms improve with lower extremity revascularization, and this is an important quality-of-life parameter that will need to be addressed in future studies. Unfortunately, to date there is no consensus on the ideal questionnaire(s) to be used in evaluating patients with CLI. A number of smaller, single-institution studies have used a variety of generic and disease-specific instruments to assess patients undergoing revascularization for CLI (Table IV).29Nehler M.R. McDermott M.M. Treat-Jacobson D. Chetter I. Regenstein J.G. 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