Journal of Vascular Surgery
Volume 51, Issue 2 , Pages 360-371.e1, February 2010

Functional status as a prognostic factor for primary revascularization for critical limb ischemia

  • H.C. Flu, MD

      Affiliations

    • Department of Vascular Surgery, Leiden University Medical Center, Leiden, The Netherlands
    • ,
  • J.H.P. Lardenoye, MD, PhD

      Affiliations

    • Department of Vascular Surgery, Leiden University Medical Center, Leiden, The Netherlands
    • ,
  • E.J. Veen, MD

      Affiliations

    • Department of Vascular Surgery, St. Elisabeth hospital, Tilburg, The Netherlands
    • ,
  • D.P. Van Berge Henegouwen, MD, PhD

      Affiliations

    • Department of Vascular Surgery, St. Elisabeth hospital, Tilburg, The Netherlands
    • ,
  • J.F. Hamming, MD, PhD

      Affiliations

    • Department of Vascular Surgery, Leiden University Medical Center, Leiden, The Netherlands
    • Corresponding Author InformationReprint requests: J. F. Hamming, MD, PhD, Leiden University Medical Center (LUMC), Department of Vascular Surgery, Albinusdreef 2, PO Box 9600, 2300 RC Leiden, The Netherlands

Received 23 June 2009; accepted 14 August 2009.

Article Outline

Background

Lower extremity arterial revascularization (LEAR) is the gold-standard for critical lower limb ischemia (CLI). The goal of this study was twofold. First, we evaluated the long-term functional status of patients undergoing primary LEAR for CLI. Second, prognostic factors of long-term functional status and survival after primary LEAR for CLI were assessed.

Methods

All primary LEAR procedures were analyzed. Patients were stratified by preoperative functional status: ambulatory (group I) vs nonambulatory (group II). Patients were followed-up after 3 and 6 years. Adverse events (AEs) were categorized according to predefined standards: minor, surgical, failed revascularization, and systemic. Associated patient demographic/clinical data were analyzed using univariate and multivariate methods.

Results

There were 106 LEAR patients (group I: n = 42, 40% vs group II: n = 64, 60%). Group II patients were significantly older (75 vs 62 years; P = .00), were classified ASA 3-4 more frequently (78% vs 52%; P < .02), had more cardiac disease (n = 42, 66% vs n = 10, 24%; P = .00), renal disease (n = 26, 41% vs n = 7, 17%; P = .00), diabetes (n = 36, 56% vs n = 8, 19%; P = .00), hypertension (n = 47, 73% vs n = 13, 31%; P = .00) and severe CLI (n = 42, 66% vs n = 18, 38%; P < .01). Group II patients had a higher incidence of death (65.6% vs 14.3%; P = .00), minor AEs (n = 38, 26% vs n = 10, 22%; P = .00), surgical AEs (n = 48, 33% vs n = 12, 26%; P < .02) and systemic AEs (n = 24, 86% vs n = 4, 9%; P < .02). Also more unplanned reinterventions occurred in group II (n = 148, 76% vs n = 47, 24%; P = .00). Nonambulatory status was a multivariate independent predictor of nonambulatory status after LEAR during 6 years follow-up (odds ration [OR[: 21.47; 95% confidence interval [CI]: 2.76-166.77; P = .00). Pulmonary disease (OR: 7.49; 95% CI: 2.17-25.80; P = .00), not prescribing β-blockers (OR: 4.67; 95% CI: 1.28-17.03; P < .02), nonambulatory status (OR: 22.99; 95% CI: 6.27-84.24; P = .00), and systemic AEs (OR: 9.66; 95% CI: 1.84-50.57; P < .01) were independent predictors of death. Functional status was not improved in group II after long-term follow-up.

Conclusion

Nonambulatory patients suffer from extensive comorbid conditions. They are accompanied with an increased occurrence of AEs, unplanned reinterventions, and poor long-term survival rates. Successful LEAR did not improve their functional status after 6 years. This emphasizes that attempts for limb salvage must be carefully considered in these patients.

 

With aging of the population and improved medical care, vascular physicians face an ever increasing number of elderly patients with progressed forms of peripheral arterial occlusive disease (PAOD).1 There will be approximately between 500 and 1000 new cases of critical lower limb ischemia (CLI) every year in a European or North American population of 1 million, and the prevalence has been estimated to be 1 per 2500 inhabitants.2, 3 These patients represent about 1% of the total number of patients with PAOD.2, 3 They frequently have arterial disease affecting several vascular beds and suffer from other significant comorbidities such as diabetes mellitus, respiratory disease, and renal disease.

The treatment options of CLI patients can broadly be classified into optimal medical management and invasive treatment. The optimal medical management often consists of lifestyle modification (smoking cessation, dietary management, and supervised walking exercise) and medical comanagement (lipid-lowering agents, antiplatelet agents, heart rate and blood pressure regulation).2, 3, 4, 5, 6 It has been shown to be effective in decreasing the risk of cardiovascular morbidity and improving long-term survival.2, 3, 4, 7, 8 The invasive treatment consists of vascular (endovascular and/or surgical treatment) and nonvascular (drainage, minor and major amputations) treatment.

The primary goals of CLI treatment are to relieve ischemic pain, heal ischemic ulcers, prevent limb loss, improve patient function and quality of life (QOL), and prolong patient survival. However, most CLI patients have a tremendous disease burden, with poor baseline function, including loss of functional status and ability to live independently. Their prognosis is associated with their multiple comorbid diseases, which may also influence the patient's QOL2, 9 and functional status. The 5-year survival of these CLI patients is relatively poor and compares with patients with cancer (≤50%).10, 11

Extensive lower extremity arterial revascularization (LEAR) in patients with CLI is indicated for patients who are independently functioning without extensive comorbid conditions. However, LEAR in nonambulatory CLI patients with extensive comorbid conditions without a likelihood that they will benefit functionally in terms of maintaining or improving ambulatory status and pain relief remains questionable. In selected high-risk patients, a primary major amputation after CLI is thought by some to be a better option rather than sequential hospital admissions with reinterventions, wound complications, and weeks of hospitalization due to failed revascularization attempts,2, 3, 12, 13, 14, 15, 16, 17 a topic that was addressed previously by Moore et al18, 19 in the 1980s.

The purpose of this study was twofold. First, we attempted to determine the outcome of functional status and patient survival undergoing primary LEAR for CLI. Second, we attempted to assess which prognostic factors may be of importance in determining functional status and survival after primary LEAR.

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Methods 

Patients 

This study was evaluated and approved by the institutional review board. All 106 consecutive patients without a history of LEAR or amputations were included. Criteria for inclusion was critical limb ischemia (CLI); ischemic rest pain (Fontaine stage 3) with a resting AP < 40 mm Hg; and gangrene or nonhealing ischemic ulceration (Fontaine stage 4) with a resting AP < 60 mm Hg, corresponding with categories 4, 5, and 6 of the Society of Vascular Surgery/North American Chapter of the International Society for Cardiovascular surgery (SVS/ISCVS) standards6 and according to the Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease (TASC)2, 3 guidelines. In case of in diabetic patients, CLI was diagnosed by clinical findings in combination with signs of diminished perfusion and radiologic diagnostics (computed tomography angiography/digital subtraction angiography). The included femoral popliteal lesions were according to the TASC-classification type B, C, or D for plaque morphology.2, 3

Functional status 

As listed in Appendix I, online only, the functional status was evaluated according to the functional independence measure.20 It was determined before (inclusion period: January 2001 till January 2003) and after (3 years and 6 years) primary LEAR. The patients were followed up at the time of their death to determine their functional status.

Risk factors and comorbidity 

Risk factors, the American Society of Anesthesiologists (ASA) classification,21 and body mass index (BMI)22 were registered prospectively during the admission intake. Risk factor classification and management was according to the SVS/ISCVS standards, TASC, and AHA/ACC4, 23 guidelines.

Medical comanagement 

Medication use according to the TASC and AHA/ACC reporting standards was listed by the patients at baseline. Prescribed drugs recorded for purposes of analysis were reviewed and classified according to the following categories: antiplatelet agents, β-blockers, and HMG-CoA-reductase inhibitors.

Invasive treatment of CLI 

As listed in Table II, revascularization was divided in primary LEAR and unplanned reinterventions. LEAR was divided in percutaneous transluminal angioplasties (PTAs) and bypass graft procedures (BGPs). PTAs were carried out by conventional balloon dilatation of the lesion with or without stent placement and were performed under local anesthesia with or without sedation. Bypass graft procedures (BGP) were performed according to standard vascular techniques, using preferably reversed vein for femoral popliteal (supra- and infragenual) and crural BGPs. The BGP patency was determined by duplex ultrasound examination and ankle-brachial indices in all patients 4 weeks after LEAR. The definition of primary and secondary patency, the decision to intervene and the type of reintervention were driven by the SVS/ISCVS and TASC reporting standards. All operations were performed by or under the supervision of a vascular surgeon.

Adverse events 

In The Netherlands, the Association of Surgeons of the Netherlands (ASN) has agreed on one common definition of Aes.24 This definition (Appendix II, online only) differs from that used in other studies because it has been chosen with the explicit aim of excluding subjective judgment on cause and effect, and right and wrong. This definition did not change during the study period. As listed in Appendix II, online only, Appendix III, online only, the AEs were subdivided into four groups: minor, surgical, failed revascularization, and systemic.

Registration and statistical analysis 

Patient information was registered prospectively in an electronic patient file (Oracle database) used for all patients during their admission intake. Statistical analyses were performed through a computerized software package, using SPSS 16.0 for Windows. Patient characteristics, reinterventions, and AEs were analyzed with the Mann-Whitney U-Test. Univariate analyses (χ2 and unpaired Student t test) and multivariate logistic regression models (Cox regression) were conducted. The Kaplan-Meier survival method was used to calculate the time curve of the cumulative primary and secondary patency, limb salvage, and patient survival rates determined at regular intervals after primary LEAR. The log-rank test was used for comparison of these survival rates. For all statistical analyses, P value <.05 was considered to be statistically significant.

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Results 

Patients' characteristics 

Comorbidity 

Fifty-six men (53%) and 50 women (47%) underwent LEAR (Table I). Forty-two (40%) represented group I and 64 (60%) group II. Mean age was 70 (range 47-93) years (group I: 62 range 47-85 years vs group II: 75 range 55-93 years, P = .00). There was a difference concerning the ASA-classification; 68% of all patients (n = 72) were ASA 3-4 (group I: n = 22, 52% vs group II: n = 50, 78%, P < .02). There was no difference with regard to the BMI, 44% of all patients (n = 46) were overweight or obese (group I: n = 15, 36% vs group II: n = 31, 48%, P = .09). Concerning the comorbidity, more patients in group II suffered from cardiac disease (P = .00), renal disease (P < .01), diabetes mellitus (P = .00), and hypertension (P = .00). More patients in group I were current smokers (P = .00) and suffered from hyperlipidemia P = .00). Resulting in a mean patient SVS-ISCVS risk score of 0.78 (group I: 0.50 vs group II: 0.97, P = .00).

Table I. Patient characteristics of all patients with primary CLI stratified by functional status prior to LEAR
CharacteristicsTotalGroup IGroup IIP value
Gender .13a
Male56(53)26(62)30(47)
Female50(47)16(38)34(53)
Age
Mean, years706275.00a
(Min;max), years(47;93)(47;85)(55;93)
BMI .09a
Normal60(57)27(64)33(52)
Overweight40(38)15(36)25(39)
Obesity6(6)0(0)6(9)
ASA-classification <.02a
Classification 234(32)20(48)14(22)
Classification 368(64)21(50)47(73)
Classification 44(4)1(2)3(5)
Comorbidity
Cardiac disease52(49)10(24)42(66).00a
Pulmonary disease33(31)13(31)20(31).97a
Renal disease33(31)7(17)26(41)<.01a
Diabetes mellitus44(42)8(19)36(56).00a
Hypertension60(57)13(31)47(73).00a
Tobacco use65(61)23(55)32(50).00a
Hyperlipidemia46(43)26(62)20(31).00a
Carotid disease24(23)7(17)17(27).23a
SVS/ISCVS
Risk factors
Median (SD), n3.4(1.8)2(1.8)4(1.8).01b
(Min;max), n(1;8)(1;8)(1;8)
Risk score
Mean (SD)0.78(0.56)0.50(0.54)0.97(0.55).00a
(Min;max)(0.0;2.3)(0.0;1.8)(0.1;2.3)
Secondary prevention
Antiplatelet agent81(76)30(71)51(80).33a
β-blocker82(77)32(76)50(78).82a
HMG-CoA-reductase inhibitors91(86)36(86)55(86).97a
ABI at baseline mean (SD)0.46(0.22)0.47(0.21)0.45(0.22).17b
Fontaine-classification <.01a
Classification 348(45)26(62)22(34)
Classification 458(55)16(38)42(66)
TASC-classification
Femoral popliteal lesions .23a
Type B lesion39(37)19(45)20(31)
Type C lesion16(15)7(17)9(14)
Type D lesion51(48)16(38)35(55)

LEAR, Lower extremity arterial revascularization; CLI, critical limb ischemia; group I, independent; group II, dependent; ASA, American society of anesthesiologists; BMI, body mass index; normal, BMI 18.5-24.9 kg/m2; overweight, BMI 25.0-29.9 kg/m2; obesity, BMI > 30 kg/m2; SVS-ISCVS, Society of Vascular Surgery/North American Chapter, International Society of Cardiovascular Surgery; ABI, ankle-brachial index; TASC, Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease.

Data are presented as n and (%), unless otherwise specified.

aχ2 test.

bMann-Whitney test.

Medical comanagement 

With respect to the medical comanagement (Table I), no difference was identified: antiplatelet agents (group I: n = 30, 71% vs group II: n = 51, 80%, P = .33), β-blockers (group I: n = 32, 76% vs group II: n = 50, 78%, P = .82), and HMG-CoA-reductase inhibitors (group I: n = 36, 86% vs group II: n = 55, 86%, P = 0.97). Between 75% and 86% of the patients were on target of the TASC and AHA/ACC reporting guidelines concerning the medical comanagement.

Peripheral arterial occlusive disease 

There was a difference concerning the Fontaine-classification (Table I): 45% (n = 45) were classified Fontaine 3 and 55% (n = 58) Fontaine 4 (Fontaine 3: group I: n = 26, 62% vs group II: n = 22, 34% and Fontaine 4: group I: n = 16, 38% vs group II: n = 42, 66% P < .01). There was no difference (Table I) concerning the TASC type of femoral popliteal lesion (TASC B: group I: n = 19, 45% vs group II: n = 20, 31% and TASC C: group I: n = 7, 17% vs group II: n = 9, 14% and TASC D: group I: n = 16, 38% vs group II: n = 35, 55%, P = .23).

Invasive treatment of CLI 

Primary LEAR 

There was a difference with regard to PTAs (n = 39, 37%), (group I: n = 20, 47% vs group II: n = 19, 30%, P < .01). A total of 67 primary BGPs (64%): reversed vein was used in 57 (85%) and PTFE was used in 10 BGPs (15%). There was no difference (Table II) concerning BGPs (femoral popliteal SG group I: n = 7, 17% vs group II: n = 9, 14% and femoral popliteal IG group I: n = 12, 29% vs group II: n = 18, 28% and femoral crural group I: n = 3, 7% vs group II: n = 18, 28%, P = .07).

Table II. Summary of primary LEAR and unplanned reinterventions of all patients with primary CLI stratified by functional status after LEAR
CharacteristicsTotalGroup IGroup IIP value
Primary LEAR106(35)42(40)64(60).10a
PTA39(37)20(47)19(30)<.01a
Femoral popliteal: type B lesion39(37)20(47)19(30)
BGP67(63)23(55)45(70).07a
Femoral popliteal SG16(15)7(17)9(14)
Femoral popliteal IG30(28)12(29)18(28)
Femoral crural21(20)3(7)18(28)
Unplanned reinterventions195(65)47(24)148(76).00b
Vascular89(46)31(66)58(38).13b
RoBGP28(14)12(26)16(57)
RiBGP2(1)0(0)2(1)
PTA28(14)7(15)21(14)
BGP22(11)11(23)11(7)
Hemorrhage9(5)1(2)8(5)
Nonvascular106(54)16(34)90(61)<.01b
Wound drainage9(5)2(4)7(5)
Skin grafting8(4)2(4)6(4)
Necrotectomy40(21)8(17)32(22)
Minor amputation37(19)4(9)33(22)
BKA3(2)0(0)3(2)
AKA9(5)0(0)9(6)
Patients with reinterventions58(55)15(36)43(67).00a
Total interventions301(100)89(30)212(70).00b

CLI, Critical limb ischemia; LEAR, lower extremity arterial revascularization; BGP, bypass graft procedure; SG, supragenual; IG, infragenual; PTA, percutaneous transluminal angioplasty; group I, ambulatory; group II, nonambulatory; RoBGP, revascularization of bypass graft; RiBGP, removal infected bypass graft; BKA, below knee amputation; AKA, above knee amputation.

Data are presented as n and (%), unless otherwise specified.

aχ2 test.

bMann-Whitney test.

Reinterventions 

There was a difference (Table II) among the patients who underwent reinterventions (group I: n = 15, 36% vs group II: n = 43, 67%, P = .00). There was also a difference in all reinterventions (total: n = 195, 65%; group I: n = 47, 24% vs group II: n = 148, 76%, P = .00; vascular: n = 89, 46%; group I: n = 31, 66% vs group II: n = 58, 38%, P = .13 and nonvascular: n = 106, 54%; group I: n = 16, 34% vs group II: n = 90, 61%, P < .01). All major amputations (below knee amputation: n = 3, 2% and above knee amputation: n = 9, 6%) occurred in group II patients.

In hospital adverse events 

One hundred ninety-two AEs (Table III) occurred in 62 patients (58%). There was a difference with regard to the patients who underwent AEs (group I: n = 14, 33% vs group II: n = 48, 75%, P = .00). There was also a difference in the total of AEs (group I: n = 46, 24% vs group II: n = 146, 76%, P = .00; minor: n = 48, 25%; group I: n = 10, 22% vs group II: n = 38, 26%, P = .00; surgical: n = 60, 31%; group I: n = 12, 26% vs group II: n = 48, 33%, P < .02; systemic: n = 28, 15%; group I: n = 4, 9% vs group II: n = 24, 86%, P <.02).

Table III. Summary of adverse events of all patients with primary CLI stratified by functional status prior to LEAR
CharacteristicsTotalGroup IGroup IIP value
Minor48(25)10(22)38(26).00b
Line infection1(1)0(0)1(1)
Urinary tract infection13(7)3(7)10(7)
Blister/ulcer2(1)0(0)2(1)
Other miscellaneous6(3)1(2)6(4)
Delay to operation room8(4)0(0)8(5)
Delay to medical doctor5(3)3(7)2(1)
Error in judgment5(3)1(2)4(3)
Incomplete hospital record7(4)2(4)5(3)
Surgical60(31)12(26)48(33)<.02b
Wound infection25(13)4(9)21(14)
Wound dehiscence6(3)2(4)4(3)
Hemorrhage18(9)5(11)13(9)
Gangrene10(5)0(0)10(7)
Other1(1)1(2)0(0)
Failed revascularization56(29)20(43)36(25)<.16b
Failed BGP46(24)19(41)27(18)
Failed PTA10(5)1(2)9(6)
Systemic28(15)4(9)24(86)<.02b
Respiratory Insufficiency2(1)0(0)2(1)
Pneumonia3(2)1(2)2(1)
Arrhythmia3(2)0(0)3(2)
Cardiac arrest3(2)1(2)2(1)
Cardiogenic shock3(2)0(0)3(2)
Congestive heart failure4(2)0(0)4(3)
Myocardial infarction4(2)0(0)4(3)
Shock1(1)1(2)0(0)
Septicemia2(1)0(0)2(1)
Stroke3(2)1(2)2(1)
Patients
With adverse events62(58)14(33)48(75).00a
Who died during follow-up48(45)6(14)42(66).00a
Total adverse events192(100)46(24)146(76).00b

LEAR, Lower extremity arterial revascularization; group I, ambulatory; group II, nonambulatory; BGP, bypass graft procedure; PTA, percutaneous transluminal angioplasty.

Data are presented as n and (%), unless otherwise specified.

aχ2 test.

bMann-Whitney test.

Functional status 

Before primary LEAR, 40% of the patients (42 of 106) were ambulatory and 60% (64 of 106) were nonambulatory (Table IV, Fig 1, Fig 2).

Table IV. Functional status of all patients prior primary LEAR and during follow-up: 3 years and 6 years
Prior primary LEARAfter 3 years of follow-upAfter 6 years of follow-up
StatusTotalAmbulatoryNonambulatoryDiedAmbulatoryNonambulatoryDied
Ambulatory42(40)38(90)2(5)2(5)35(76)5(11)6(13)
Nonambulatory64(60)8(13)30(47)26(41)0(0)18(56)14(44)
Total106(100)46(43)32(30)28(27)35(45)23(29)20(26)

LEAR, Lower extremity arterial revascularization.

Data are presented as n and (%), unless otherwise specified.

  • View full-size image.
  • Fig 2. 

    Functional status of all critical lower limb ischemia (CLI) patients stratified by functional status before primary lower extremity arterial revascularization (LEAR) and during follow-up (3 and 6 years).

Follow-up at 3 years 

Forty-three percent (n = 46) were ambulatory, 30% (n = 32) nonambulatory, and 27% (n = 28) died (Fig 1, Fig 2, Fig 3). Of the 42 (40%) ambulatory patients before LEAR, 38 (90%) remained ambulatory, two (5%) worsened to nonambulatory status, and two (5%) were not alive at 3 years. Of the 64 (60%) nonambulatory patients before LEAR, 30 (47%) remained nonambulatory, eight (13%) improved their status to ambulatory, and 26 (41%) were not alive at 3 years. Overall, preoperative ambulatory status was maintained in 87% (n = 68) of survivors, worsened in 2.6% (n = 2), and improved in 10% (n = 8) of survivors at 3 years.

Follow-up at 6 years 

Thirty-three percent (n = 35) were ambulatory, 22% (n = 23) were nonambulatory, and 45% (n = 48) had died (Fig 1, Fig 2, Fig 3). Of the 42 (40%) ambulatory patients before LEAR, 35 (83%) remained ambulatory, one (2%) worsened to the nonambulatory status, and six (14%) were not alive at 6 years. Of the 64 nonambulatory patients (60%) before LEAR, 22 (34%) remained nonambulatory and 42 (66%) were not alive at 6 years. Overall, preoperative ambulatory status was maintained in 98% (n = 57) and worsened in 2% (n = 1) of the survivors at 6 years.

Predictive factors 

Table V and Fig 3 list the relationship between patient characteristics and functional and living status after LEAR.

Table V. Univariate and multivariate Cox regression analysis of CLI patient characteristics predicting for functional and living status
CharacteristicsUnivariate regressionMultivariate regression
OR95% CIP valueOR95% CIP value
Functional status Nonambulatory
BMI
Overweight/obesity13.00(2.03-82.96).02
Comorbidity
Diabetes mellitus2.74(1.06-7.10).04
Functional status
Nonambulatory21.47(2.76-166.77).0021.47(2.76-166.77).00
Living status
Death
ASA-classification
Classification 33.05(1.36-6.83).01
Fontaine-classification
Classification 42.09(0.95-4.59).06
Comorbidity
Cardiac disease3.80(1.69-8.52).00
Pulmonary disease3.61(1.51-8.61).007.49(2.17-25.80).00
Renal disease3.61(1.51-8.61).00
Diabetes mellitus2.23(1.04-4.90).04
Hypertension2.52(1.13-5.61).02
Carotid disease3.12(1.19-8.14).02
Secondary preventiona
β-blocker2.47(0.97-6.31).054.67(1.28-17.03)<.02
Functional status
Nonambulatory11.45(4.18-31.33).0022.99(6.27-84.24).00
Secondary procedures2.46(1.11-5.43).03
Adverse events3.69(1.60-8.49).00
Minor3.01(1.36-6.96).02
Systemic15.35(3.32-70.87).009.66(1.84-50.57)<.01

LEAR, Lower extremity arterial revascularization; CLI, critical limb ischemia; OR, odds ratio; CI, confidence interval; ASA, American Society of Anesthesiologists; BMI, body mass index.

Data are presented as n and (%), unless otherwise specified.

Univariate analysis was performed using χ2 test and unpaired Student t test. A multivariate logistic regression model was fitted that was based on all patient characteristics that had a P value <.05 in the univariate analysis. The effect of patient characteristics, secondary prevention, functional status, reinterventions and AEs on the patients' functional and living status and AEs were assessed using the Cox regression model to estimate odds ratios (OR) and their 95% confidence intervals (CI).

aNot prescribing medication concerning secondary prevention.

Functional status 

BMI, diabetes mellitus, and nonambulatory status were significantly correlated with nonambulatory status after 6 years. Including these variables in the multivariate analysis, only nonambulatory status (OR: 21.47; 95% CI: 2.76-166.77; P = .00) remained an independent predictive risk factor for postoperative nonambulatory status.

Long-term survival 

ASA-3, Fontaine-4, cardiac, pulmonary, renal, and carotid disease, diabetes mellitus, hypertension, not prescribing β-blockers, nonambulatory status, the occurrence of reinterventions, and AEs were significantly correlated with early death 6 years after LEAR. Including these variables in the multivariate analysis, pulmonary disease (OR: 7.49; 95% CI: 2.17-25.80; P = .00), not prescribing β-blockers (OR: 4.67; 95% CI: 1.28-17.03; P < .02), nonambulatory status (OR: 22.99; 95% CI: 6.27-84.24; P = .00), and systemic AEs (OR: 9.66; 95% CI: 1.84-50.57; P < .01) remained independent predictive risk factors for early death.

Patency, limb salvage, and survival 

The AE “failed revascularization” occurred 56 times (group I: n = 20, 43% vs group II: n = 36, 35%, P < .16) in these series. There was no difference (Table VI) concerning primary patency rates of all PTAs after 6 years (all: 87.7%; group I: 95.7% vs group II: 82.4%, P = .63). There was also no difference (Table VI) concerning primary and secondary patency rates of all BGPs after 6 years (all: 52.6%; group I: 77.4% vs group II: 35.7%, P = .25) and (all: 77.6%; group I: 87.9% vs group II: 72.2%, P = .30), respectively.

Table VI. Cumulative life-table primary and secondary patency rates, limb salvage, and patient survival rates stratified by preoperative functional status
1 month6 months12 months24 months36 months48 months60 months72 months
BGP
Primary patency
All91(87.6)76(78.3)66(71.2)60(63.8)50(63.8)43(63.8)42(52.6)31(52.6)
Group I34(100)31(93.5)29(90.3)28(77.4)24(77.4)23(77.4)23(77.4)22(77.4)
Group II57(82.5)45(73.8)37(63.8)32(59.6)26(59.6)20(59.6)19(35.7)9(35.7)
Secondary patency
All91(93.3)81(85.1)72(81.6)69(79.1)63(79.1)56(79.1)55(77.6)50(77.6)
Group I34(100)33(93.3)31(90.9)30(87.9)29(87.9)28(87.9)28(87.9)27(87.9)
Group II57(90.9)48(81.2)41(77.3)39(75.2)34(75.2)28(75.2)27(72.2)23(72.2)
PTA
Primary patency
All65(96.8)59(96.8)57(91.6)52(89.8)47(89.8)44(87.8)43(87.8)36(87.8)
Group I26(100)25(100)25(100)24(100)24(100)23(95.7)22(95.7)21(95.7)
Group II39(94.7)34(94.7)32(85.7)28(82.4)23(82.4)21(82.4)21(82.4)15(82.4)
Limb salvage
All106(95.1)93(90.9)85(89.8)82(87.5)73(87.5)65(87.5)64(87.5)56(87.5)
Group I42(100)41(100)41(97.6)40(97.6)40(95.1)39(95.1)39(92.7)38(87.8)
Group II64(100)52(92.0)44(89.9)42(85.2)33(85.2)26(85.2)25(85.2)18(85.2)
Patient survival
All106(100)98(95.9)94(93.9)92(86.7)85(78.6)77(77.6)76(69.4)68(59.2)
Group I42(100)41(100)41(97.6)40(97.6)40(95.1)39(95.1)39(92.7)38(87.8)
Group II64(100)57(93.0)53(91.2)52(78.9)45(66.7)38(64.9)37(52.6)30(38.6)

BGP, Bypass graft procedure; PTA, percutaneous transluminal angioplasty; group I, ambulatory; group II, nonambulatory.

Data are presented as at risk and (%), unless otherwise specified.

The Kaplan-Meier survival method was used to calculate the time curve of the cumulative primary - and secondary patency, limb salvage and patient survival rates determined at regular intervals: 1-, 6-, 12-, 24-, 36-, 48-, 60- and 72-months after primary LEAR. The log-rank test was used for comparison of these survival rates.

There was a difference concerning limb salvage rates of all limbs (Table VI and Fig 4) after 6 years (all: 87.5%; group I: 100% vs group II: 85.2%, P < .03).

  • View full-size image.
  • Fig 4. 

    Kaplan-Meier curve of the cumulative limb salvage rates of all limbs stratified by preoperative ambulatory (n = 42, 40%) and nonambulatory (n = 64, 60%) status after 6 years follow-up.

Forty-eight patients died (≤30 days: n = 8, 28%; <30 days and 3 years]: n = 20, 42%; <3 - and 6 years]: n = 20, 42%) after LEAR (Table VI, Table VII). There was a difference (Table VI and Fig 5) concerning the patient survival rates after 6 years (all: 59.2%; group I: 87.8% vs group II: 38.6%, P = .00).

Table VII. Causes of death during follow-up: 30 days, 3, and 6 years
Cause of deathTotal30 days3 years6 years
Cardiac17(35)6(35)8(47)3(18)
Pulmonary3(6)0(0)3(100)0(0)
Renal2(4)0(0)1(50)1(50)
Cerebral2(4)1(33)0(0)1(50)
Hemorrhage3(6)1(33)0(0)2(67)
Malignancy2(4)0(0)0(0)2(100)
Unknown19(40)0(0)8(42)11(58)
Total patients died48(100)8(16)20(42)20(42)

Data are presented as n and (%), unless otherwise specified.

  • View full-size image.
  • Fig 5. 

    Kaplan-Meier curve of the cumulative patient survival rates stratified by preoperative ambulatory (n = 42, 40%) and nonambulatory (n = 64, 60%) status after 6 years follow-up.

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Discussion 

Contemporary care of CLI consists of near universal attempts of LEAR. The overall decision for limb salvage must consider not only the foot and the technical aspects of LEAR but also the patient's comorbidity and expected outcomes.25 This information can and must have serious influence on the decision concerning which exact therapy is the best approach for each individual CLI patient. This study was conducted to obtain insight in functional status and long-term survival after LEAR in CLI patients. Furthermore, several important prognostic factors influencing functional status and survival in this specific patient population were assessed.

Functional status prior LEAR: ambulatory vs nonambulatory 

Patient characteristics 

Assessing patients' characteristics reveals that the nonambulatory patients were high-risk patients suffering from extensive comorbid conditions and severe CLI. Compared with the ambulatory patients, the nonambulatory patients were characterized by a higher SVS/ISCVS risk score and ASA classification 3-4 at time of LEAR. They were older, suffered from cardiac disease, renal disease, hypertension, hyperlipidemia, and diabetes mellitus. Also, most of the nonambulatory patients in this study were diagnosed with Fontaine classification 4, the most severe form of CLI.

Reintervention and adverse events after primary LEAR for CLI 

Almost all reinterventions in the postoperative period were performed in the nonambulatory patient group. The reintervention and AE rate in the nonambulatory patient group is significantly higher compared with the ambulant patient group. This is due to the more severe comorbid condition of these patients. However, the high reintervention rate in the nonambulatory patients implicates an increased risk of new AEs, total length of stay, increased morbidity, and health care costs. Furthermore, these reinterventions and AEs result in an increased physical and mental burden for the CLI patient. The risk of postoperative AEs is directly related to preoperative general health status and presence of severe comorbidity.26 Reports have also confirmed that patients undergoing LEAR have an increased risk of perioperative cardiac AEs.27, 28

Limb salvage 

Results of the traditional measures of outcome of LEAR were primary and secondary patency rates of 52.6% and 77.6%, respectively, and a total limb salvage rate of 87.5%. They were in correspondence with findings in other reports.2, 29, 30, 31

Important to stress is that the limb salvage in the nonambulatory patients was significantly worse after 6 years; all unplanned major amputations only occurred in these patients.

Functional status and long-term survival after primary LEAR for CLI 

In this study, at time of primary LEAR, 40% of the CLI patients were ambulatory and 60% non ambulatory. After long-term follow-up (6 years), 48 patients died (45%) and for those patients who survive, 60% was ambulatory and 40% nonambulatory after primary LEAR.

Ambulatory 

Ambulatory status at time of LEAR in CLI patients is a positive predicting factor concerning long-term functional status.12, 29, 32, 33, 34 This was also the finding in our study; the status of patients who were ambulatory prior to LEAR (40%) was rarely worsened by LEAR after 3 and 6 years, respectively. Also most of the patients in this group (86%) were alive after 6 years.

Nonambulatory 

The findings of this study implicate that the majority of non ambulant patients with satisfactory technical outcome after LEAR, including limb salvage, will experience no improvement in functional status. These findings are in agreement with the literature.29, 32, 33 In this study, the patients' nonambulatory status at time of LEAR was an independent predictive risk factor of functional status after 6 years. Also, BMI (overweight/obesity) and DM were correlated with nonambulatory status after 6 years. Although there may be compelling reasons to consider LEAR in nonambulatory patients, our results suggest that such procedures should be considered carefully, as return to ambulatory status is almost never achievable. Therefore, the consideration for LEAR in most of these patients should be to improve the QOL by decreasing pain level, sleep problems, and heal foot lesion in patients with CLI.35, 36

Prognostic factors for survival after primary LEAR for CLI 

Many studies have described increased mortality after LEAR for CLI with risk factors such as diabetes, smoking, cardiac disease, and cerebrovascular atherosclerosis.11, 29, 30, 37, 38 In this study, cardiac, pulmonary, carotid, and renal disease, DM, and hypertension were correlated with early death. The severity of limb ischemia is also an important predictor of death rates.39 In this study, there was also a correlation between the severity of ischemia (Fontaine classification 4) and early death. Patients' nonambulatory status at time of LEAR, not prescribing a β-blocker, and the occurrence of systemic AEs were independent predictive risk factors for early death. The latest AHA/ACC guidelines4, 23 on perioperative care recommend initiating β-blocker treatment in patients with one or more cardiovascular clinical risk factors. As stated in the literature,40 the occurrence of reinterventions (major amputations) after primary LEAR was associated with significantly worse long-term survival. The previously reported 5-year survival rate for CLI patients ranged from 12% to 64%, with a mean of 45% to 60%.29, 31, 32, 33 The survival rate of the patients in this study of 59.2% at 6 years is similar to multiple previous reports, with a 30-days mortality rate of 7%.

Evaluation of the optimal treatment of CLI: primary LEAR - or major amputation 

Nonambulatory patients have a significant decreased chance of ambulatory status after LEAR due to their comorbidity, the occurrence of Aes, and reinterventions. LEAR is preferable to primary major amputation in cost as well as in allowing the patient to regain functional life.41, 42, 43 However, the overall decision for limb salvage must also consider the patient's comorbidity and expected outcomes.25 Careful consideration should be focused on chances of successful revascularization with subsequent relief of pain and limb salvage vs repeated failed revascularization attempts inducing increased patient morbidity and ultimately major amputation. The ongoing topic of controversy is primary LEAR vs primary major amputation, particularly in patients with CLI.12, 13, 14 As noted in the TASC guidelines, there are patients who will benefit from primary amputation rather than extensive LEAR. Subgroups of the CLI patients currently undergoing extensive limb salvage efforts may be better served with primary amputation. Recent studies demonstrate that there appears to be no difference in QOL or functional outcome between primary LEAR and major amputation during follow-up.14, 15, 16 Also, in selected high-risk patients an early primary major amputation may be preferred above weeks of hospitalization to undergo repeated revascularization attempts and wound treatment attempting to heal distal wounds. If subgroups of CLI patients are better served by primary amputation, how can they be identified? Several variables are to be taken into account when deciding the type of treatment (primary LEAR or major amputation) in case of CLI, such as: functional status and independence, mental status (e.g. dementia), comorbidity, pain, wound status (e.g. size and complexity in the foot), fixed and unremediable flexion contracture,4, 23 technical issues of LEAR, nutritional status and life expectancy. If salvage of a leg can keep it functional for assisted transfers from bed to chair, rather than have a patient who is a “dead lift” bedridden person who cannot easily transfer to a chair, LEAR is good treatment option. Limb salvage will continue to be the overriding goal for most CLI patients referred to vascular therapy, but a subset of these patients is clearly better served with a primary major amputation.

Limitations and strength of the study 

Several remarks have to be made concerning potential limitations of this study. This study is limited by the relative small cohort of high-risk patients who were referred to a single center. Furthermore, since patients with previous surgical treatment of CLI were excluded in this study, results of our study cannot be extrapolated in this specific patient category. However, to the best of our knowledge, this is the first study to compare functional status before and long-term (3 and 6 years) after LEAR for CLI with detailed analysis of prognostic factors of morbidity and mortality in this specific patient population.

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Conclusion 

Patients with good functional status before LEAR almost universally maintain this status 6 years after primary LEAR. Preoperative nonambulatory high-risk comorbid CLI patients infrequently experience improvement in functional status after LEAR, they frequently experience AEs and reinterventions, and have especially poor long-term survival rates, emphasizing that attempts at limb salvage must be carefully considered in these patients. Within our multivariate analysis, we identified nonambulatory as an independent predictive risk factor for post LEAR nonambulatory status. Also pulmonary disease, not prescribing β-blockers, nonambulatory status, and systemic AEs were independent predictive risk factors for early death. Surgeons and CLI patients should consider these variables to inform decision making when considering revascularization in these high-risk settings.

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Author contributions 


Conception and design: HC, JH, EJ

Analysis and interpretation: HC, JH, EJ

Data collection: HC, EJ

Writing the article: HC, JH, EJ, DP, JF

Critical revision of the article: HC, JH, DP, JF

Final approval of the article: JH, JF

Statistical analysis: HC

Obtained funding: N/A

Overall responsibility: JF

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Appendices (online only) 

Appendix I, online only. Functional status (mobility/type of transfer and locomotion) classified according to the functional independence measure
GroupDefinition of the functional status
Ambulatory group I
Another person is not needed to complete an activity

Included independent/outside, restricted/indoors, and assisted (with cane or walker).

Nonambulatory group II
The patient can at least put forth half or more of the energy to complete an activity or the patient puts forth less than half the energy, requires maximal or total assistance, or even worse, the activity is not performed at all

Included wheelchair dependent or bed-bound patients.

Appendix II, online only. Classification of AEs and an explanation of the causes of these AEs
CategoryaCause of the AEb (group 1-4)Outcome (category I-V)

Cardiac

Pulmonary

Neurology

Renal

(Sub)cutis

Muscles/skeleton

Hematology

Vascular

Management


1.minor

2.surgical

3.failed revascularization

4.systemic


I.no consequence

II.additional transfusion/medication

III.reoperation

IV.irreversible physical damage

V.death

AE, Adverse event.

An unintended and unwanted event or state occurring during or following medical care, that is so harmful to a patient's health that (adjustment of) treatment is required or that permanent damage results. The AE may be noted during hospitalization, until 30 days after discharge or transferee to another department. The intended result of treatment, the likelihood of the adverse outcome occurring, and the presence or absence of a medical error causing it, is irrelevant in identifying an adverse outcome.

Minor: an AE such as: urinary tract infection, deep venous thrombosis.

Surgical: an AE due to surgical treatment, such as: abscess, wound infection, wound necrosis, wound dehiscence, hemorrhage.

Failed revascularization: when a primary bypass graft occluded, or at risk for occlusion and surgical or endovascular reintervention was performed. It was also defined when an anatomical arterial segment occluded after a PTA was performed on that same segment.

Systemic: potential life threatening AEs, such as: pneumonia, respiratory failure, arrhythmia, cardiac arrest, cardiogenic shock, congestive heart failure, myocardial infarction, shock, stroke.

aGeneral definition of an AE.

bExplanation and definition of the causes of perioperative AEs.

Appendix III, online only. Subdivision of specific AE categories
Cardiac
Congestive heart failure
Arrhythmia
Cardiac arrest
Myocardial infarction
Endocarditis/pericarditis
Cardiogenic shock
Hypertension/hypotension
Tachycardia/bradycardia
Pulmonary
Respiratory insufficiency
Aspiration/pneumonia
Pleural fluid
Atelectasis
Embolism
Neurology
Cerebrovascular accident
Transient ischemic attack
Neuropraxia
Renal
Renal failure
End-stage renal disease
Urinary tract infection
Urinary retention
Pyelonephritis/hydronephritis
(Sub)cutis
Blister/ulcer
Abscess
Epidermolysis
Seroma
Cellulites
Wound hematoma
Wound infection
Wound dehiscence
Necrosis/unexpected tissue loss
Muscles/skeleton
Compartmental syndrome
Osteomyelitis
Hematology
Spontaneous hemorrhage
Heparin induced thrombocytopenia
Transfusion reaction
Decrease hemoglobin
Thrombosis from ATIII, or protein C or S deficiency
Septicemia
Fluid and electrolytes
Vascular management
Line infection
Deep venous thrombosis
Infection BGP
Stenosis BGP/anatomical segment after PTA
Occlusion BGP/anatomical segment after PTA
Anastomotic pseudoaneurysm/anatomical segment after PTA
Hemorrhage
General management
Error in medication/in diagnosis/in judgment/in technique
Delay to OR/in MD response/in diagnosis
Incomplete hospital record

BGP, Bypass graft procedure; PTA, percutaneous transluminal angioplasty; OR, operating room; MD, medical doctor.

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 Competition of interest: none.

 Additional material for this article may be found online at www.jvascsurg.org.

 The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a competition of interest.

PII: S0741-5214(09)01697-8

doi:10.1016/j.jvs.2009.08.051

Journal of Vascular Surgery
Volume 51, Issue 2 , Pages 360-371.e1, February 2010

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