Study
N
Age range
Procedure/Outcome
Group 1
Group 2
P Value
Saarinen (2015) [34]
233
92* (90–100)
Surgical vs. Endovascular
Surgical
Endovascular
1-year survival
50.9%
48.6%
0.505
Limb salvage
85.1%
87.9%
0.259
Amputation-free survival
45.7%
44.4%
0.309
Chang (2001) [35]
383
70–79
Bypass, Septuagenarian vs. Octogenarian
Septuagenarians
Octogenarians
209
80–89
5-year survival
64%
54%
>0.2
5-year primary patency
68%
74%
>0.2
5-year limb salvage
86%
86%
NS
Brosi (2007) [37]
167
85.4** (80–94.9)
Surgical or endovascular vs. medical,
Octogenarians
Nonoctogenarians
249
69.3** (40.3–79.9)
Octogenarians vs. Nonoctogenarians
Primary clinical success
26.6%
31.2%
NS
Secondary clinical success
50.6%
55.0%
NS
Major amputation
22.3%
23.6%
NS
Repeated revascularization
48.3%
40.4%
NS
Masaki (2014) [33]
131
BY 70* (46–89)
Bypass vs. Endovascular
Bypass
Endovascular
33
EV 72* (47–89)
3-year primary patency
72%
54%
<0.009
3-year secondary patency
82%
60%
NR
3-year limb salvage
86%
82%
NS
Adam (2005) [32]
BY 228
EV 224
Bypass vs. Endovascular
Unadjusted †
Adjusted †
<70 35%
<70 30%
6-month amputation free survival
1.07 (0.72–1.6)
1.04 (0.69–1.56)
NS
70–79 39%
70–79 46%
Entire follow-up amputation-free survival
0.89 (0.68–1.17)
0.88 (0.66–1.16)
NS
≥80 26%
≥80 26%
Entire follow-up all-cause mortality
0.90 (0.66–1.22)
0.95 (0.69–1.29)
NS
Simons (2012) [47]
2110
CLI 69.9* ± 11.4
Bypass, CLI vs. Claudication
CLI
Claudication
797
IC 64.3* ± 10.4
1-year major amputation
12.2%
1.6%
<0.0001
1-year primary patency
66.4%
78.9%
<0.0001
1-year secondary patency
77.4%
89%
<0.0001
In a recent study of nonagenarians referred for CLI or acute limb ischemia, 83% were living independently prior to surgery , with 72% remaining independent afterwards [34]. Eighty-two percent of the 91% that were ambulatory preoperatively maintained this status postoperatively. Both preoperative living status and ambulatory ability were no different between endovascular and open approaches. Dementia was the single and poor predictor of poor amputation-free survival in this cohort. In a study of septuagenarians and octogenarians with lower extremity CLI undergoing bypass procedures, 5-year survival was 54% and 64%, primary patency 74% and 68%, and limb salvage rate 86% in both age groups [35]. The authors suggest that these age groups stand to benefit from revascularization as a means to relieve symptoms and avoid the morbidity of amputation.
Improved stratification of PAD patients would assist clinical decision-making. To create a prediction score for the composite outcome of amputation and mortality at 1 year, researchers used data from the PREVENT III cohort (Project of Ex-Vivo graft Engineering via Transfection III) [36]. This dataset included 1404 patients with CLI who underwent infrainguinal bypass with autogenous vein. In this model, age greater than or equal to 75 years was an independent predictor of amputation and death in multivariable analysis and given two points in the risk score (HR 1.64, 95% CI 1.21–2.22, p = 0.001). Age alone was associated with an amputation-free survival of 89.7%. These results were also confirmed in an observation study of octogenarians with CLI [37]. In this cohort, periprocedural mortality in octogenarians was much higher after surgical bypass as compared to endovascular. Those who did survive had similar outcomes at 1 year as compared to those under 80, suggesting that there may be a cohort of older patients who will benefit from intervention. Other risk scores have identified similar factors from large cohorts, unfortunately none have been prospectively validated on all-comers presenting with CLI [38, 39]. See Table 8.2 for a summary of available prediction scores .
Table 8.2
Prediction models for patients undergoing revascularization for critical limb ischemia
Finnvasc [38] | Prevent III [36] | BASIL [39] | CRAB [48] | |
|---|---|---|---|---|
Variables | One point each for: Diabetes CAD Gangrene Urgent operation | Dialysis = 4 points Tissue loss = 3 points Age ≥ 75 y = 2 points Hematocrit <30 = 2 points Advanced CAD = 1 point | Tissue loss BMI Creatinine Bollinger score Age Smoking History of MI or angina Ankle pressure | Emergent case = 6 points Total functional dependence = 6 points Hemodialysis = 4 points Recent angina/MI = 4 points Age > 75 y = 3 points Prior amputation/revascularization = 3 points Ulceration = 3 points Partial functional dependence = 3 points |
Output | 0–4 risk points | Low ≤ 3points Medium = 4–7 points High ≥ 8 points | Weibull model predicted survival: http://basiltrial.com/survival_predictor.htm | Low = 0–6 points Medium = 7–12 points High > 12 points |
Derivation Cohort | Finnvasc registry | PREVENT III cohort | BASIL trial | ACS-NSQIP 2007–2009 |
External Validation | Yes | Yes | No | No |
Outcome | Major amputation and or death after infrainguinal revascularization for CLI | AFS after infrainguinal vein bypass for CLI | Death at 6, 12, and 24 months after LE bypass or angioplasty for CLI | Perioperative death or major morbidity after LE bypass for CLI |
Adapted from Moxey et al. [49]
Abbreviations: AFS amputation free survival, CRAB comprehensive risk assessment for bypass, CLI critical limb ischemia, LE lower extremity, MI myocardial infarction, y years
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