- Email: [email protected]
Functional outcomes in limb salvage vascular surgery
Functional Outcomes in Limb Salvage Vascular Surgery Margaret M. Duggan, MD, Jonathan Woodson, MD, Thayer E. Scott, MPH, Alexander N. Ortega, BA, James O. Menzoian, MD, Boston, Massachusetts
BACKGROUND: The crisis in health care brings a new focus to defining successful o u t c o m e s of medical treatments. The surgical literature has been criticized for not assessing functional outcomes in addition to technical success. METHODS: W e evaluated the functional outc o m e s o f limb salvage surgery over 3 years in 3 8 patients 6 5 years o f age and older with limb-threateplng ischemia. The R A N D - 3 6 - h e m Health Survey 1 . 0 was used as a health assessm e n t tool. RESULTS: In spite o f an 8 0 % limb salvage rate, only 5 8 % o f patients survived 3 years and only 2 5 % survived with the index limh and were able to walk. The R A N D scores o f patients whose limbs were amputated did not significantly differ from those o f patients whose surgery was successful. CONCLUSION: Functional o u t c o m e goals need to be better defined for patients who need limb salvage vascular operations to e n h a n c e the quality o f care given these patients and to be in concert with e m e r g i n g health policy.
he ongoing debate over health care reform has brought T new emphasis to evaluating the outcomes of medical and surgical treatments. The Agency for Health Care Policy
purchase health c a r e / G o o d outcomes in 1994 and beyond will be defined by treatments that are both therapeutically and cost effective, that satisfy patients, and that produce good functional results. 2"5 Medical specialists in general, and surgeons in particular, have been reluctant to embrace the new methodology of health services2 researchers in our methods of reporting data. 6"8 As a result, it has become more common to have our outcomes evaluated by persons outside our field, with remarkably different results as demonstrated in the paper by Tunis et al,9 in which the increased use of percutaneous transluminal angioplasty is loosely linked with the increased use of peripheral bypass and a rise in cost but no decline in amputation rates over the decade between 1979 and 1989 in the state of Maryland. With the introduction of health care reform and the movement toward global health care budgets, we can expect intensified efforts regarding outcomes research. Measures of the quality of life and functional health have already found their way into the outcome evaluations of cancer therapy, cardiac disease therapy, and transplant surgery. Because many vascular surgery patients are Medicare recipients and because the procedures are expensive and consume many hospital days, vascular surgeons can anticipate closer scrutiny in the near future. 10-13Public disclosure of data relating to outcomes of cardiac surgery is already a fact of life in some states, for example, in New York.
and Research was established in 1989 with the mandate to accrue information on the outcomes of treatments and to establish practice guidelines. Outcomes analysis and practice guidelines have been embraced as key features to ensure quality care under the new Clinton health reform plan. The Administration is looking toward models such as the Outcomes Management System (OMS), developed by Dr. Paul Ellwood of the American Group Practice Association and the Managed Health Care Association, as a method for gathering patient-specific outcomes data. The OMS uses a health status questionnaire based on the Medical Outcome Study Short Form (MOS SF36) and the Technology of Patient Experience (TYPE) form to assess perceived health and functional status information, and demographic, morbidity, and quality-of-life information. Dr. EUwood is a strong proponent of public disclosure of such information so that consumers may decide from whom to
METHODS To better define the functional benefits of peripheral bypass procedures for patients needing limb salvage vascular surgery, we retrospectively identified 70 patients with threatened limbs through the Boston University Medical Center Vascular Registry between December 1990 and June 1993. Only 38 patients met the inclusion criteria and had complete medical records available for review. The criteria for inclusion in this study were: Age 65 years old or older (Medicare age); for patients without diabetes, an ankle/brachial index of 0.4 or less; for patients with diabetes, an ankle/brachial index of 0.6 or less; and rest pain or nonhealing distal extremity and foot ulcers or gangrene. The patients' records were reviewed for basic demographic and comorbidity information, as well as for relevant information regarding the index limb salvage procedure. Based on these data, the patients were placed into one of two groups: limb salvage (patent graft) or limb loss From the Departmentof Surgery, Secuon of VascularSurgery, Boston (bypass failure). UniversitySchool of Medicine, Boston,Massachusetts. To reduce question bias, a research assistant--rather than Requests for reprints should be addressed to Jonathan Woodson,MD, the surgeon of record--interviewed all patients by teleDepartment of Surgery, Section of Vascular Surgery, 88 East Newton phone or in person and administered the RAND-36-Item Street, Boston,Massachusetts02118. Presented at the 22nd Annual Meeting of the Society for Clinical Health Assessment Survey Version 1.0 (or RAND-36, for Vascular Surgery, Tucson, Arizona, March 2-6, 1994. short). This survey identifies eight health parameters: (1) 188
THE AMERICANJOURNALOF SURGERY® VOLUME168 AUGUST1994
FUNCTIONAL OUTCOMES IN LIMB SALVAGF./DUGGAN El' AL
D G~
B (f~lures)l Gene~i l-lmlm
d
fiIGroup B (failures)] • Group A (patent) ]
I~
I
Pain
Social ~ m
-60
40
-20
untts (em r ) unttal {ph k ) 0
20
40
•"igure 1. Funcbonal outcomes of limb salvage surgery according to :~AND-36scores. Preoperative versus postoperative (left to nght) health ~arametersare shown. Group A = patients with patent bypasses; group q = pa~ents with faded bypasses.
~hysical functioning, (2) bodily pain, (3) role limitation lue to physical health, (4) role limitation due to personal ~r emotional problems, (5) emotional well-being, (6) so:ial functioning, (7) energy/fatigue level, and (8) general :~ealth perception. The RAND-36 is identical to the Medical Outcomes Study Short Form 36 described and validated by Ware and ~herbourne 14 in the Medical Outcomes Study reported in 1992. The scoring system has been simplified under the RAND protocol in that each item is scored so the lowest and highest scores possible are 0 and 100, respectively. Scores represent the percentage of total scores achieved. In step two of the scoring process, the items in the same scale are averaged to create the eight scale scores (Figure 1). Items left blank (missing data) are not taken into account when calculating scores, hence scale scores represent the average for all items in the scale that the patient answered. We asked the questions on the RAND-36 twice: The first time patients were asked to focus on their health status before the surgery; and the second time, after surgery, they were asked to focus on the 4-week period immediately before the interview. (All interviews conducted after surgery allowed enough time so that acute surgical pain or wound complications would not influence responses.) We also analyzed the scores of individual categories of questions, such as bodily pain (Figure 2), and compared the preoperative and postoperative responses between groups. RESULTS The average age of patients was 72.1 years (range 65 to 92); 55% were men and 45% were women; 71% were white, 23.9% were black, and 2.3% were Hispanic; 70% • I~ad diabetes; 25% had had a stroke or transient ischemic attack (but all were ambulatory before the development of limb-threatening ischemia), 56% had evidence of coronary artery disease demonstrated by active angina or prior myocardial infarction, 16.2% had undergone coronary artery bypass grafting, 18.9% had chronic renal failure, and 10.8% were dependent on dialysis. The average length of follow-up was 18.6 months (range 3 to 30 ). The rate of limb loss over this period was 27% (5.5% early limb loss). The perioperative complication rate was 31%. Most complications were minor with the
1 I
I
-60
-40
:
1
-20
0
Bathe/Dress (12) Walk I block (11) Walk say. blocks (10) Walk > 1 mile (9) Bending (8) Climb 1 flight (7) Climb > 1 flight (6) Lifting (5) Moderate activities (4) Vigorous activities (3) Gsne~l Health (2) 20
Figure 2. Funchonal outcomes of limb salvage surgery according to RAND-36 scores. Preoperalave versus postoperative (left to right) scores are shown for RAND-36 questions 2 through 12. Group A = pahents with patent bypasses; group B = pahents with faded bypasses.
exception of two major events, myocardial infarction and stroke, that resulted in death. The perioperative mortality rate was 5.2%, and 39% of patients died within 2 years of surgery. Forty-three percent of patients had undergone prior vascular surgery, and 13.5% had previous vascular surgery on the index limb. All patients underwent infrainguinal bypass procedures: 81% had femorotibial bypass (including peroneal and dorsalis pedis) and 18.9% had femoropopliteal bypass. At follow-up, 25% of the patients were alive and using the index limb.
Results of RAND-36 Scoring A focused analysis of the RAND-36 responses was performed for 21 patients (17 in the limb-salvage group and 4 in the limb-loss group). Only 21 respondents were available of the original 38 because of the nearly 40% mortality in the study; also, some patients were incapacitated by other medical problems such as strokes. Wilcoxon's rank sum test was used for analysis. The analysis of questions 4, 8, and 10 (Figure 2), which reflect functional status, demonstrated no statistically significant difference in performing moderate activity or walking between patients whose bypass failed and patients whose bypass remained patent. Based on visual comparison of mean scores for each question, however, the trend for scoring present health assessment (that is, how patients are "feeling now") indicated that patients with patent bypasses scored higher than patients with failed bypasses. Using both the t-test and Wilcoxon's rank sum test, analysis of questions 2 through 12 (Figure 2) pertaining to general health and mobility showed no statistically significant differences between the groups. That is, statistically, patients with functioning bypasses did not report themselves as being better off than patients with failed bypasses. Closer scrutiny, however, reveals a more disturbing picture, in that both groups consistently report a decline in general health and mobility. Notably, and surprisingly, the negative trend was greater for the patients with functioning bypasses. Finally, patients with failed bypass reported greater pain relief (a stronger positive trend) than did patients who had patent bypasses. That f'mding was not statistically significant, but a trend was seen. The mean score difference for the failed-bypass group was 35.6 compared with 14.5 for the patent-bypass group (Figure 1).
THE AMERICAN JOURNAL OF SURGERY*
VOLUME 168 AUGUST 1994
189
FUNCTIONAL OUTCOMES IN LIMB SALVAGE/DUGGAN ET AL
COMMENTS Both early and late mortality and morbidity are high among patients who undergo limb salvage vascular operations, and the procedures are more likely to be complicated by comorbid conditions such as coronary artery disease, diabetes, and stroke. A review of the literature reveals 5-year survival rates of only 21% to 50%. ~524 Although primary and secondary patency rates for infrainguinal bypass range from 60% to 80%, certain subgroups have been shown to have worse outcomes. Diabetes alone has not consistently been linked to increased failure rates, 25-27but the combination of diabetes and renal failure reduces survival to 21% at 5 years and reduces graft patency significantly. 28,29 Repetitive operations such as thrombectomy and revision of the bypass graft, and adjunctive procedures such as thrombolysis, may be necessary to maintain bypass patency and to achieve wound closure, especially when associated with tissue loss or gangrene. Alternative therapies such as primary amputation or pain management without surgical intervention are considered suboptimal by many vascular surgeons in light of the higher mortality rates and lower rehabilitation rates reported for patients, particularly older patients, on these management protocols. 3°-35 Vascular surgeons, and vascular surgery as a specialty, have expended great effort to standardize outcomes reporting. Strandness and C a r t e r 36 and DeWeese et al37 present clear and insightful algorithms for reporting outcomes of medical and surgical therapies for treating peripheral artery disease, requiring criteria such as the arm/ankle index, total capacity PO 2, toe systolic pressure, morbidity and mortality rates, and cumulative patency rates. Noticeably absent from these criteria, however, but increasingly important to nonvascular surgeons, patients, policy makers, and insurers are the parameters, tools, and recommendations for evaluating functional health and quality-of-life issues. Some efforts at reporting these findings are beginning. Schneider et al38 reported on their results using the MOS (SF20) for 60 patients undergoing aortobifemoral bypass for occlusive disease. They found that physical function, role function, and health perception were worse among patients undergoing successful aortobifemoral grafting compared with control patients. Mangione et al,39 presented data showing improvement in MOS scores postoperatively for 126 patients who underwent carotid endarterectomy (36 patients), abdominal aortic aneurysm resection (14 patients), and lower extremity vascular reconstruction (45 patients). Limb-salvage patients formed only a small part of this study group (19 patients), and that may account for the more positive results. Albers et al40 has proposed the use of Spitzer's Qualityof-Life Index to assess quality of life in patients with infrainguinal occlusive disease. According to their report, patients treated conservatively had higher mean scores on this index than did patients who underwent revascularization or amputation. CONCLUSIONS In summary, our findings show the following: 1. Patients undergoing limb salvage surgery report a decline in physical function and in perceptions of general 190
health after surgery. Considering the population studied, this finding may suggest that these patients are in a declining life cycle and that bypass, even when successful, may not be sufficient to improve overall function. 2. It is possible that addressing rehabilitation issues earlier in the care of these patients may produce a more positive functional outcome. Patients who have had strokes or have debilitating arthritis may lose substantial functional ability during convalescence from peripheral bypass surgery, which may take weeks to heal, especially when associated with gangrene or ulceration. 3. There is no statistically significant difference in health perceptions between patients with successful limb salvage and patients with failed bypass grafts requiting amputation. That may be explained by comorbid conditions that continue to deteriorate in spite of limb salvage interventions. 4. There is no difference between patients with successful bypasses and patients with failed bypasses in the amount of pain reported. In this study, patients whose bypasses failed became amputees, and it is not surprising that amputation was an effective pain control measure. 5. Further study of functional outcomes in limb salvage surgery is warranted. Knowledgeable consumers and managed competition will challenge us to produce new types of data supporting the position of vascular surgeons on the effectiveness of the surgical therapies they advocate. Therapies that do not improve functional status yet cost more will likely receive less support under the emerging health care strategy. Data that help patients and their families in making difficult decisions when a successful outcome is not guaranteed will be mandatory. Recent work41 has shown that judgments regarding treatment value do not always match when patients and doctors are surveyed separately. As professionals, we will need to respond to the new challenges if we are to remain legitimate contributors to the health care debate.
REFERENCES 1. Spencer V, Reichard J, eds. The 1993-94 Medical Outcomes and Guidelines Source. New York: Faulkner & Gray; 1993. 2. Ware JE Jr. Conceptualizing and measuring generic health outcomes. Cancer. 1991;67(suppl):774--780. 3. Ware JE Jr. Standards for validating health measures: definition and content. J Chron Dis. 1987;40:473-480. 4. McHomey.CA,Ware JE Jr, Rogers W, et al. The validity and relative precision of MOS Short- and Long-Form Health Assessment Scales and Dartmouth COOP Charts. Results from the Medical Outcomes Study. Medical Care. 1992;30:(suppl):MS253-265. 5. Stewart AL, Greenfield S, Hayes RD, et al. Functional status and well-being of patients with chronic conditions. Results from the Medical Outcomes Study. JAMA. 1989;262:907-913. 6. Guyatt GH, Feeny DH, Patrick DL. Measuringhealth-relatedquality of hfe. Ann Intern Med. 1993;118:622-628. 7. Fraser SCA. Quality of life measurement in surgical practice. Br J Surg. 1993;80:163-169. 8. Delbanco TL. Enriching the doctor-patient relationship by inviting the patient's perspective.Ann Intern Med. 1992;I16:414--418. 9. Tunis SR, Bass EB, Steinberg EP. The use of angioplasty, bypass surgery and amputation in the management of peripheral vascular disease. NEJM. 1991;325:556-562. 10. Munoz E, Cohen J, Chang J, et al. Socioeconomicconcems in vascular surgery: a survey of the role of age, resource consumption, and outcome in treatment cost. J Vasc Surg. 1989;9:479--486.
THE AMERICANJOURNALOF SURGERY° VOLUME168 AUGUST1994
FUNCTIONAL'OUTCOMES'IN LIMB'SAL3TAGE/DUC,~A.N'ET AL II. Mackey WC, McCullough JL, Conlon TP, et al. The cost of ,urgery for limb-threathening ischemia. Surgery. 1986;99:26--34. 12. Gupta SK, Veith FJ. Inadequacy of diagnosis related group IDRG) reimbursement for limb salvage lower extremity arterial reonstructions. J Vase Surg. 1990; 11:348-356. ~3. Park RE, Fink A, Brook RH, Chassin MR, et al. Physician rat.ngs of appropriate indications for six medical and surgical procedures. Am J Public Health. 1986;76:766-772. 14. Ware JE Jr, Sherboume CD. The MOS 36-Item Short-Form , lealth Survey (SF-36). I. Conceptual framework, and item selection. ,ted Care. 1992;30:473--483. 5. Veith FJ, Gupta SK, Samson RH, et al. Progress in limb salvage '-,y reconstructive arterial surgery combined with new or improved djunctive procedures. Ann Surg. 1981;194:386-399. 6. Hobson RW H, Lynch TG, Jamil Z, et al. Results of revaseular,ation and amputation in severe lower extremity ischemia: a fiveear clinical experience. J Vasc Surg. 1985;2:174--182. 7. Moody AP, Edwards PR, Harris PL. Femoropopliteal vein grafts: ong term follow-up of prospective, randomized trial. Br J Surg. ~992;79:750--752. ~8. Harrington EB, Harrington ME, Schanzer H, Jacobson JH. The _lorsalis pedis bypass---moderate success in difficult situations. J ~PascSurg 1992; 15:409--414. t9. Shortell CK, Ouriel K, DeWeese JA, Green RM. Peroneal artery 'vpass: a multifactorial analysis. Ann Vasc Surg. 1992;6:15-19. 20. Shah DM, Darling RC 111,Chang BB, et al. Is long vein bypass *tom groin to ankle a durable procedure? An analysis of a ten-year zxperience. J Vase Surg. 1992; 15:402-407. 21. Stoney ILl, James DR, Wylie EJ. Surgery for femoropopliteal ltherosclerosis. A reappraisal. Arch Surg. 1971; 103:548-552. 22. Stoney ILl. Ultimate salvage for the patient with limb-threaten,ng ischemia. Realistic goals and surgical considerations. Am J Surg. 1978;136:228-232. 23. O'Donneli JA, Brener BJ, Brief DK, et al. Realistic expectations for patients having lower extremity bypass for limb salvage. Arch ~urg. 1977;112:1356-1363. 24. Maguant JG, Cronenwett JL, Walsh DB, et al. Surgical treatment of infrainguinal arterial occlusive disease in women. J Vasc Surg. 1993; 17:67-76. 25. Kwolek CJ, Pomposelli FK, Tannenbaum GA, et al. Peripheral vascular bypass in juvenile-onset diabetes mellitus: are aggressive revascularization attempts justified? J Vase Surg. 1992;15:394--400.
26. Pomposelli FB, Jepsen SJ, Gibbons GW, et al. Efficacy of the dorsalis pedis bypass for limb salvage in the diabetic patients: shortterm observations. J Vasc Surg. 1990;11:745-751. 27. Rosenblatt MS, Quist WC, Sidawy AN, et al. Results of vein graft reconstruction of the lower extremity in diabetic and nondiabetic patients. Surg Gynecol Obstet. 1990;171:331-335. 28. Chang BB, Paty RSK, Shah DM, et al. Results of infrainguinal bypass for limb salvage in patients with end-stage renal disease. Surgery. 1990;108:742-747. 29. Whittemom AD, Donaldson MC, Mannick JA. Infralnguinal reconstruction for patients with chronic renal insufficiency. J Vasc Surg. 1993;17:32-39. 30. Gmgg RO. Bypass or amputation? Concomitant review of bypass arterial grafting and amputations. Am J Surg. 1985; 149:397---402. 31. Couch NP, David JK, Tilney NL. Natural history of the leg amputee. Am J Surg. 1977;133:469. 32. Bodily KC, Burgess EM. Contralateral limb and patient survival after leg amputation. Am J Surg. 1983;6:280--282. 33. Keagy BA, Schwartz JA, Kotb M, et al. Lower extremity amputation: the control series. J Vase Surg. 1986;4:321-326. 34. Evans WE, Hayes JP, Vermilion BD. Rehabilitation of the bilateral amputee. J Vasc Surg. 1987;5:589-593. 35. High RM, McDowell DE, Sarvin RA. A critical review of amputation in vascular patients. J Vasc Surg. 1984;1:653-655. 36. Strandness DE Jr, Carter SA. Outcome criteria in patients with peripheral arterial disease. Ann Vase Surg. 1993;7:491-496. 37. DeWeese JA, Leather R, Porter J. Practice guidelines: lower extremity revascularization. J Vasc Surg. 1993;18:28000293. 38. Schneider JR, McHomey CA, Malenka DJ, et al. Functional health and well-being in patients with severe atheroselemtic peripheral vascular occlusive disease. Ann Vasc Surg. 1993;7:419--428. 39. Mangione CM, Donaldson MC, Cook EF, et al. Perception of change in health patients undergoing elective vascular surgery. Presented at the 19th Annual Meeting of the New England Society for Clinical Vascular Sugery; September 24--25, 1992; Dixville Notch, New Hampshire. 40. Albers M, Fratezi AC, DeLucia N. Assessment of quality of life of patients with severe ischemia as a result of infralnguinal arterial occlusive disease. J Vasc Surg. 1992;16:54--58. 41. Wasson J, Fleming C, Bruskewitz R, et al. The treatment of localized prostate cancer: what are we doing, what do we know, and what should we be doing. Semin Urol. 1993;9:23-26.
THE AMERICAN JOURNAL OF SURGERY® VOLUME 168 AUGUST 1994 191
BACKGROUND: The crisis in health care brings a new focus to defining successful o u t c o m e s of medical treatments. The surgical literature has been criticized for not assessing functional outcomes in addition to technical success. METHODS: W e evaluated the functional outc o m e s o f limb salvage surgery over 3 years in 3 8 patients 6 5 years o f age and older with limb-threateplng ischemia. The R A N D - 3 6 - h e m Health Survey 1 . 0 was used as a health assessm e n t tool. RESULTS: In spite o f an 8 0 % limb salvage rate, only 5 8 % o f patients survived 3 years and only 2 5 % survived with the index limh and were able to walk. The R A N D scores o f patients whose limbs were amputated did not significantly differ from those o f patients whose surgery was successful. CONCLUSION: Functional o u t c o m e goals need to be better defined for patients who need limb salvage vascular operations to e n h a n c e the quality o f care given these patients and to be in concert with e m e r g i n g health policy.
he ongoing debate over health care reform has brought T new emphasis to evaluating the outcomes of medical and surgical treatments. The Agency for Health Care Policy
purchase health c a r e / G o o d outcomes in 1994 and beyond will be defined by treatments that are both therapeutically and cost effective, that satisfy patients, and that produce good functional results. 2"5 Medical specialists in general, and surgeons in particular, have been reluctant to embrace the new methodology of health services2 researchers in our methods of reporting data. 6"8 As a result, it has become more common to have our outcomes evaluated by persons outside our field, with remarkably different results as demonstrated in the paper by Tunis et al,9 in which the increased use of percutaneous transluminal angioplasty is loosely linked with the increased use of peripheral bypass and a rise in cost but no decline in amputation rates over the decade between 1979 and 1989 in the state of Maryland. With the introduction of health care reform and the movement toward global health care budgets, we can expect intensified efforts regarding outcomes research. Measures of the quality of life and functional health have already found their way into the outcome evaluations of cancer therapy, cardiac disease therapy, and transplant surgery. Because many vascular surgery patients are Medicare recipients and because the procedures are expensive and consume many hospital days, vascular surgeons can anticipate closer scrutiny in the near future. 10-13Public disclosure of data relating to outcomes of cardiac surgery is already a fact of life in some states, for example, in New York.
and Research was established in 1989 with the mandate to accrue information on the outcomes of treatments and to establish practice guidelines. Outcomes analysis and practice guidelines have been embraced as key features to ensure quality care under the new Clinton health reform plan. The Administration is looking toward models such as the Outcomes Management System (OMS), developed by Dr. Paul Ellwood of the American Group Practice Association and the Managed Health Care Association, as a method for gathering patient-specific outcomes data. The OMS uses a health status questionnaire based on the Medical Outcome Study Short Form (MOS SF36) and the Technology of Patient Experience (TYPE) form to assess perceived health and functional status information, and demographic, morbidity, and quality-of-life information. Dr. EUwood is a strong proponent of public disclosure of such information so that consumers may decide from whom to
METHODS To better define the functional benefits of peripheral bypass procedures for patients needing limb salvage vascular surgery, we retrospectively identified 70 patients with threatened limbs through the Boston University Medical Center Vascular Registry between December 1990 and June 1993. Only 38 patients met the inclusion criteria and had complete medical records available for review. The criteria for inclusion in this study were: Age 65 years old or older (Medicare age); for patients without diabetes, an ankle/brachial index of 0.4 or less; for patients with diabetes, an ankle/brachial index of 0.6 or less; and rest pain or nonhealing distal extremity and foot ulcers or gangrene. The patients' records were reviewed for basic demographic and comorbidity information, as well as for relevant information regarding the index limb salvage procedure. Based on these data, the patients were placed into one of two groups: limb salvage (patent graft) or limb loss From the Departmentof Surgery, Secuon of VascularSurgery, Boston (bypass failure). UniversitySchool of Medicine, Boston,Massachusetts. To reduce question bias, a research assistant--rather than Requests for reprints should be addressed to Jonathan Woodson,MD, the surgeon of record--interviewed all patients by teleDepartment of Surgery, Section of Vascular Surgery, 88 East Newton phone or in person and administered the RAND-36-Item Street, Boston,Massachusetts02118. Presented at the 22nd Annual Meeting of the Society for Clinical Health Assessment Survey Version 1.0 (or RAND-36, for Vascular Surgery, Tucson, Arizona, March 2-6, 1994. short). This survey identifies eight health parameters: (1) 188
THE AMERICANJOURNALOF SURGERY® VOLUME168 AUGUST1994
FUNCTIONAL OUTCOMES IN LIMB SALVAGF./DUGGAN El' AL
D G~
B (f~lures)l Gene~i l-lmlm
d
fiIGroup B (failures)] • Group A (patent) ]
I~
I
Pain
Social ~ m
-60
40
-20
untts (em r ) unttal {ph k ) 0
20
40
•"igure 1. Funcbonal outcomes of limb salvage surgery according to :~AND-36scores. Preoperative versus postoperative (left to nght) health ~arametersare shown. Group A = patients with patent bypasses; group q = pa~ents with faded bypasses.
~hysical functioning, (2) bodily pain, (3) role limitation lue to physical health, (4) role limitation due to personal ~r emotional problems, (5) emotional well-being, (6) so:ial functioning, (7) energy/fatigue level, and (8) general :~ealth perception. The RAND-36 is identical to the Medical Outcomes Study Short Form 36 described and validated by Ware and ~herbourne 14 in the Medical Outcomes Study reported in 1992. The scoring system has been simplified under the RAND protocol in that each item is scored so the lowest and highest scores possible are 0 and 100, respectively. Scores represent the percentage of total scores achieved. In step two of the scoring process, the items in the same scale are averaged to create the eight scale scores (Figure 1). Items left blank (missing data) are not taken into account when calculating scores, hence scale scores represent the average for all items in the scale that the patient answered. We asked the questions on the RAND-36 twice: The first time patients were asked to focus on their health status before the surgery; and the second time, after surgery, they were asked to focus on the 4-week period immediately before the interview. (All interviews conducted after surgery allowed enough time so that acute surgical pain or wound complications would not influence responses.) We also analyzed the scores of individual categories of questions, such as bodily pain (Figure 2), and compared the preoperative and postoperative responses between groups. RESULTS The average age of patients was 72.1 years (range 65 to 92); 55% were men and 45% were women; 71% were white, 23.9% were black, and 2.3% were Hispanic; 70% • I~ad diabetes; 25% had had a stroke or transient ischemic attack (but all were ambulatory before the development of limb-threatening ischemia), 56% had evidence of coronary artery disease demonstrated by active angina or prior myocardial infarction, 16.2% had undergone coronary artery bypass grafting, 18.9% had chronic renal failure, and 10.8% were dependent on dialysis. The average length of follow-up was 18.6 months (range 3 to 30 ). The rate of limb loss over this period was 27% (5.5% early limb loss). The perioperative complication rate was 31%. Most complications were minor with the
1 I
I
-60
-40
:
1
-20
0
Bathe/Dress (12) Walk I block (11) Walk say. blocks (10) Walk > 1 mile (9) Bending (8) Climb 1 flight (7) Climb > 1 flight (6) Lifting (5) Moderate activities (4) Vigorous activities (3) Gsne~l Health (2) 20
Figure 2. Funchonal outcomes of limb salvage surgery according to RAND-36 scores. Preoperalave versus postoperative (left to right) scores are shown for RAND-36 questions 2 through 12. Group A = pahents with patent bypasses; group B = pahents with faded bypasses.
exception of two major events, myocardial infarction and stroke, that resulted in death. The perioperative mortality rate was 5.2%, and 39% of patients died within 2 years of surgery. Forty-three percent of patients had undergone prior vascular surgery, and 13.5% had previous vascular surgery on the index limb. All patients underwent infrainguinal bypass procedures: 81% had femorotibial bypass (including peroneal and dorsalis pedis) and 18.9% had femoropopliteal bypass. At follow-up, 25% of the patients were alive and using the index limb.
Results of RAND-36 Scoring A focused analysis of the RAND-36 responses was performed for 21 patients (17 in the limb-salvage group and 4 in the limb-loss group). Only 21 respondents were available of the original 38 because of the nearly 40% mortality in the study; also, some patients were incapacitated by other medical problems such as strokes. Wilcoxon's rank sum test was used for analysis. The analysis of questions 4, 8, and 10 (Figure 2), which reflect functional status, demonstrated no statistically significant difference in performing moderate activity or walking between patients whose bypass failed and patients whose bypass remained patent. Based on visual comparison of mean scores for each question, however, the trend for scoring present health assessment (that is, how patients are "feeling now") indicated that patients with patent bypasses scored higher than patients with failed bypasses. Using both the t-test and Wilcoxon's rank sum test, analysis of questions 2 through 12 (Figure 2) pertaining to general health and mobility showed no statistically significant differences between the groups. That is, statistically, patients with functioning bypasses did not report themselves as being better off than patients with failed bypasses. Closer scrutiny, however, reveals a more disturbing picture, in that both groups consistently report a decline in general health and mobility. Notably, and surprisingly, the negative trend was greater for the patients with functioning bypasses. Finally, patients with failed bypass reported greater pain relief (a stronger positive trend) than did patients who had patent bypasses. That f'mding was not statistically significant, but a trend was seen. The mean score difference for the failed-bypass group was 35.6 compared with 14.5 for the patent-bypass group (Figure 1).
THE AMERICAN JOURNAL OF SURGERY*
VOLUME 168 AUGUST 1994
189
FUNCTIONAL OUTCOMES IN LIMB SALVAGE/DUGGAN ET AL
COMMENTS Both early and late mortality and morbidity are high among patients who undergo limb salvage vascular operations, and the procedures are more likely to be complicated by comorbid conditions such as coronary artery disease, diabetes, and stroke. A review of the literature reveals 5-year survival rates of only 21% to 50%. ~524 Although primary and secondary patency rates for infrainguinal bypass range from 60% to 80%, certain subgroups have been shown to have worse outcomes. Diabetes alone has not consistently been linked to increased failure rates, 25-27but the combination of diabetes and renal failure reduces survival to 21% at 5 years and reduces graft patency significantly. 28,29 Repetitive operations such as thrombectomy and revision of the bypass graft, and adjunctive procedures such as thrombolysis, may be necessary to maintain bypass patency and to achieve wound closure, especially when associated with tissue loss or gangrene. Alternative therapies such as primary amputation or pain management without surgical intervention are considered suboptimal by many vascular surgeons in light of the higher mortality rates and lower rehabilitation rates reported for patients, particularly older patients, on these management protocols. 3°-35 Vascular surgeons, and vascular surgery as a specialty, have expended great effort to standardize outcomes reporting. Strandness and C a r t e r 36 and DeWeese et al37 present clear and insightful algorithms for reporting outcomes of medical and surgical therapies for treating peripheral artery disease, requiring criteria such as the arm/ankle index, total capacity PO 2, toe systolic pressure, morbidity and mortality rates, and cumulative patency rates. Noticeably absent from these criteria, however, but increasingly important to nonvascular surgeons, patients, policy makers, and insurers are the parameters, tools, and recommendations for evaluating functional health and quality-of-life issues. Some efforts at reporting these findings are beginning. Schneider et al38 reported on their results using the MOS (SF20) for 60 patients undergoing aortobifemoral bypass for occlusive disease. They found that physical function, role function, and health perception were worse among patients undergoing successful aortobifemoral grafting compared with control patients. Mangione et al,39 presented data showing improvement in MOS scores postoperatively for 126 patients who underwent carotid endarterectomy (36 patients), abdominal aortic aneurysm resection (14 patients), and lower extremity vascular reconstruction (45 patients). Limb-salvage patients formed only a small part of this study group (19 patients), and that may account for the more positive results. Albers et al40 has proposed the use of Spitzer's Qualityof-Life Index to assess quality of life in patients with infrainguinal occlusive disease. According to their report, patients treated conservatively had higher mean scores on this index than did patients who underwent revascularization or amputation. CONCLUSIONS In summary, our findings show the following: 1. Patients undergoing limb salvage surgery report a decline in physical function and in perceptions of general 190
health after surgery. Considering the population studied, this finding may suggest that these patients are in a declining life cycle and that bypass, even when successful, may not be sufficient to improve overall function. 2. It is possible that addressing rehabilitation issues earlier in the care of these patients may produce a more positive functional outcome. Patients who have had strokes or have debilitating arthritis may lose substantial functional ability during convalescence from peripheral bypass surgery, which may take weeks to heal, especially when associated with gangrene or ulceration. 3. There is no statistically significant difference in health perceptions between patients with successful limb salvage and patients with failed bypass grafts requiting amputation. That may be explained by comorbid conditions that continue to deteriorate in spite of limb salvage interventions. 4. There is no difference between patients with successful bypasses and patients with failed bypasses in the amount of pain reported. In this study, patients whose bypasses failed became amputees, and it is not surprising that amputation was an effective pain control measure. 5. Further study of functional outcomes in limb salvage surgery is warranted. Knowledgeable consumers and managed competition will challenge us to produce new types of data supporting the position of vascular surgeons on the effectiveness of the surgical therapies they advocate. Therapies that do not improve functional status yet cost more will likely receive less support under the emerging health care strategy. Data that help patients and their families in making difficult decisions when a successful outcome is not guaranteed will be mandatory. Recent work41 has shown that judgments regarding treatment value do not always match when patients and doctors are surveyed separately. As professionals, we will need to respond to the new challenges if we are to remain legitimate contributors to the health care debate.
REFERENCES 1. Spencer V, Reichard J, eds. The 1993-94 Medical Outcomes and Guidelines Source. New York: Faulkner & Gray; 1993. 2. Ware JE Jr. Conceptualizing and measuring generic health outcomes. Cancer. 1991;67(suppl):774--780. 3. Ware JE Jr. Standards for validating health measures: definition and content. J Chron Dis. 1987;40:473-480. 4. McHomey.CA,Ware JE Jr, Rogers W, et al. The validity and relative precision of MOS Short- and Long-Form Health Assessment Scales and Dartmouth COOP Charts. Results from the Medical Outcomes Study. Medical Care. 1992;30:(suppl):MS253-265. 5. Stewart AL, Greenfield S, Hayes RD, et al. Functional status and well-being of patients with chronic conditions. Results from the Medical Outcomes Study. JAMA. 1989;262:907-913. 6. Guyatt GH, Feeny DH, Patrick DL. Measuringhealth-relatedquality of hfe. Ann Intern Med. 1993;118:622-628. 7. Fraser SCA. Quality of life measurement in surgical practice. Br J Surg. 1993;80:163-169. 8. Delbanco TL. Enriching the doctor-patient relationship by inviting the patient's perspective.Ann Intern Med. 1992;I16:414--418. 9. Tunis SR, Bass EB, Steinberg EP. The use of angioplasty, bypass surgery and amputation in the management of peripheral vascular disease. NEJM. 1991;325:556-562. 10. Munoz E, Cohen J, Chang J, et al. Socioeconomicconcems in vascular surgery: a survey of the role of age, resource consumption, and outcome in treatment cost. J Vasc Surg. 1989;9:479--486.
THE AMERICANJOURNALOF SURGERY° VOLUME168 AUGUST1994
FUNCTIONAL'OUTCOMES'IN LIMB'SAL3TAGE/DUC,~A.N'ET AL II. Mackey WC, McCullough JL, Conlon TP, et al. The cost of ,urgery for limb-threathening ischemia. Surgery. 1986;99:26--34. 12. Gupta SK, Veith FJ. Inadequacy of diagnosis related group IDRG) reimbursement for limb salvage lower extremity arterial reonstructions. J Vase Surg. 1990; 11:348-356. ~3. Park RE, Fink A, Brook RH, Chassin MR, et al. Physician rat.ngs of appropriate indications for six medical and surgical procedures. Am J Public Health. 1986;76:766-772. 14. Ware JE Jr, Sherboume CD. The MOS 36-Item Short-Form , lealth Survey (SF-36). I. Conceptual framework, and item selection. ,ted Care. 1992;30:473--483. 5. Veith FJ, Gupta SK, Samson RH, et al. Progress in limb salvage '-,y reconstructive arterial surgery combined with new or improved djunctive procedures. Ann Surg. 1981;194:386-399. 6. Hobson RW H, Lynch TG, Jamil Z, et al. Results of revaseular,ation and amputation in severe lower extremity ischemia: a fiveear clinical experience. J Vasc Surg. 1985;2:174--182. 7. Moody AP, Edwards PR, Harris PL. Femoropopliteal vein grafts: ong term follow-up of prospective, randomized trial. Br J Surg. ~992;79:750--752. ~8. Harrington EB, Harrington ME, Schanzer H, Jacobson JH. The _lorsalis pedis bypass---moderate success in difficult situations. J ~PascSurg 1992; 15:409--414. t9. Shortell CK, Ouriel K, DeWeese JA, Green RM. Peroneal artery 'vpass: a multifactorial analysis. Ann Vasc Surg. 1992;6:15-19. 20. Shah DM, Darling RC 111,Chang BB, et al. Is long vein bypass *tom groin to ankle a durable procedure? An analysis of a ten-year zxperience. J Vase Surg. 1992; 15:402-407. 21. Stoney ILl, James DR, Wylie EJ. Surgery for femoropopliteal ltherosclerosis. A reappraisal. Arch Surg. 1971; 103:548-552. 22. Stoney ILl. Ultimate salvage for the patient with limb-threaten,ng ischemia. Realistic goals and surgical considerations. Am J Surg. 1978;136:228-232. 23. O'Donneli JA, Brener BJ, Brief DK, et al. Realistic expectations for patients having lower extremity bypass for limb salvage. Arch ~urg. 1977;112:1356-1363. 24. Maguant JG, Cronenwett JL, Walsh DB, et al. Surgical treatment of infrainguinal arterial occlusive disease in women. J Vasc Surg. 1993; 17:67-76. 25. Kwolek CJ, Pomposelli FK, Tannenbaum GA, et al. Peripheral vascular bypass in juvenile-onset diabetes mellitus: are aggressive revascularization attempts justified? J Vase Surg. 1992;15:394--400.
26. Pomposelli FB, Jepsen SJ, Gibbons GW, et al. Efficacy of the dorsalis pedis bypass for limb salvage in the diabetic patients: shortterm observations. J Vasc Surg. 1990;11:745-751. 27. Rosenblatt MS, Quist WC, Sidawy AN, et al. Results of vein graft reconstruction of the lower extremity in diabetic and nondiabetic patients. Surg Gynecol Obstet. 1990;171:331-335. 28. Chang BB, Paty RSK, Shah DM, et al. Results of infrainguinal bypass for limb salvage in patients with end-stage renal disease. Surgery. 1990;108:742-747. 29. Whittemom AD, Donaldson MC, Mannick JA. Infralnguinal reconstruction for patients with chronic renal insufficiency. J Vasc Surg. 1993;17:32-39. 30. Gmgg RO. Bypass or amputation? Concomitant review of bypass arterial grafting and amputations. Am J Surg. 1985; 149:397---402. 31. Couch NP, David JK, Tilney NL. Natural history of the leg amputee. Am J Surg. 1977;133:469. 32. Bodily KC, Burgess EM. Contralateral limb and patient survival after leg amputation. Am J Surg. 1983;6:280--282. 33. Keagy BA, Schwartz JA, Kotb M, et al. Lower extremity amputation: the control series. J Vase Surg. 1986;4:321-326. 34. Evans WE, Hayes JP, Vermilion BD. Rehabilitation of the bilateral amputee. J Vasc Surg. 1987;5:589-593. 35. High RM, McDowell DE, Sarvin RA. A critical review of amputation in vascular patients. J Vasc Surg. 1984;1:653-655. 36. Strandness DE Jr, Carter SA. Outcome criteria in patients with peripheral arterial disease. Ann Vase Surg. 1993;7:491-496. 37. DeWeese JA, Leather R, Porter J. Practice guidelines: lower extremity revascularization. J Vasc Surg. 1993;18:28000293. 38. Schneider JR, McHomey CA, Malenka DJ, et al. Functional health and well-being in patients with severe atheroselemtic peripheral vascular occlusive disease. Ann Vasc Surg. 1993;7:419--428. 39. Mangione CM, Donaldson MC, Cook EF, et al. Perception of change in health patients undergoing elective vascular surgery. Presented at the 19th Annual Meeting of the New England Society for Clinical Vascular Sugery; September 24--25, 1992; Dixville Notch, New Hampshire. 40. Albers M, Fratezi AC, DeLucia N. Assessment of quality of life of patients with severe ischemia as a result of infralnguinal arterial occlusive disease. J Vasc Surg. 1992;16:54--58. 41. Wasson J, Fleming C, Bruskewitz R, et al. The treatment of localized prostate cancer: what are we doing, what do we know, and what should we be doing. Semin Urol. 1993;9:23-26.
THE AMERICAN JOURNAL OF SURGERY® VOLUME 168 AUGUST 1994 191