Alternative Techniques for Treatment of Complex Below-the Knee Arterial Occlusions in Diabetic Patients With Critical Limb Ischemia (original) (raw)
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Journal of Vascular Surgery, 2006
This study is a review and evaluation of our 12-year experience of revascularization for critical limb ischemia (CLI) with angioplasty/stenting and bypass surgery to identify specific trends of procedure volume and outcomes in this particular group. Methods: Endovascular and open bypass procedures done for CLI by a single surgeon between 1993 and 2004 were evaluated retrospectively. Thrombolysis and thrombectomy procedures done as the only revascularization procedure were excluded from analysis. The data were divided into three groups by time periods: the first period, 1993 to 1996; the second period, 1997 to 2000; and the third period, 2001 to 2004. Outcomes were defined according to the reporting standards of the Society for Vascular Surgery/International Society for Cardiovascular Surgery. The study included 416 procedures done in 237 limbs in 192 patients. The mean follow-up was 23 months (range, 1 to 122 months). Results: Primary revascularization procedures for CLI were angioplasty in 153 limbs (65%) and bypass surgery in 84 (35%). Subsequent procedures were angioplasty in 102 limbs (57%) and open surgery (bypass and/or patch angioplasty) in 77 limbs (43%). The rates for technical and clinical success and complications in the entire group were 99%, 95%, and 4%, respectively. One patient died perioperatively (0.5%). Among the three periods, TransAtlantic Inter-Society Consensus lesion types were significantly more severe in patients in the first period (P < .05). Additionally, the complication rate was significantly higher and the mean hospital stay was significantly longer in the first period compared with the second and third periods (P < .05). Furthermore, between the first and third periods, the number of endovascular revascularization procedures done as primary and secondary procedures significantly increased from 15 to 84 (؉460%) and from 13 to 57 (؉340%), whereas the number of open surgical procedures done as primary and secondary procedures decreased from 39 to 20 (؊49%) and from 35 to 18 (؊49%), respectively (P < .0001). The assisted primary patency rates in the third period were significantly higher than those in the first and second periods (P ؍ .012); otherwise, the long-term outcomes among the three periods were not statistically different. Multivariate analysis revealed that, while controlling for other factors, the third period showed improvement in the primary patency (P ؍ .032) and assisted primary patency (P ؍ .051), and the bypass group showed improvement in the primary patency (P ؍ .008). Conclusions: In our experience, open surgical procedures for the treatment of CLI have been largely replaced by angioplasty procedures without compromising outcomes. Angioplasty is a feasible, safe, and effective procedure and can be the procedure of choice for the primary and secondary treatment of CLI. Open surgical procedures can be reserved for lesions technically unsuitable for endovascular procedures and patients who do not demonstrate clinical improvement after angioplasty.
Hybrid Revascularization Procedures in Acute Limb Ischemia
Annals of Vascular Surgery, 2014
Background: Although the clinical efficacy of hybrid procedures in patients with chronic limb ischemia has been well reported in the literature, sufficient evidence is lacking in the acute setting. Our aim was to evaluate the immediate and midterm clinical results on 28 patients with acute lower limb ischemia treated with hybrid reconstructions on emergent basis, from January 2010 to March 2013 in our tertiary referral vascular center. Methods: A total of 28 patients (31 operated limbs) underwent emergent hybrid revascularization, with endovascular treatment performed proximally or distally to the site of open reconstruction. The median follow-up period was 6 months (range: 1e26). The immediate technical success was clinically and hemodynamically evaluated with an ankle brachial pressure index (ABPI) measurement. Six-month overall patency, limb salvage, and survival rate were also estimated. All analyses were performed with KaplaneMeier life table method, using the STATIS-TICA 7.0 statistical program. Results: Twenty-seven patients presented with grade IIb and 1 with grade III ischemia, respectively. Technical success was achieved in all patients, whereas hemodynamic improvement rate was achieved in 98%. ABPI preoperatively was increased from 0.14 ± 0.1 to 0.69 ± 0.28 postoperatively (P < 0.05). Perioperative morbidity and mortality rates were 21% and 11% respectively. Six-month overall patency, limb salvage, and survival rate were 86%, 92%, and 79%, respectively. Conclusions: Hybrid revascularization in immediately threatened limbs provides an effective and durable option with acceptable mortality and amputation rate in these high-risk patients. These findings should be further confirmed by larger scale clinical studies. C.A. and E.G. have equally contributed to the article.
Catheterization and Cardiovascular Interventions, 2013
Background: Successful angioplasty is one of the main factor of limb salvage during critical limb ischemia. In complex femoropopliteal to infrapopliteal occlusions, an anterograde recanalization attempt can fail in up to 20% of the cases. The purpose of this dual center pilot study was to evaluate the acute success and clinical impact of retrograde transpedal access for retrograde below-the-knee and femoropopliteal chronic total occlusions after failed anterograde attempt and to access the late complications at the puncture site. Methods: The clinical and angiographic data of 51 consecutive patients with CLI treated by retrograde transpedal recanalization between 2010 and 2011 were evaluated in a pilot study. We have examined the 2-month and 1 year major adverse events (MAEs) and clinical success. In all cases after failure of the anterograde recanalization of occluded below-the-knee segments due to unsuccessful penetration or failed re-entry, the anterior tibial or posterior tibial artery was punctured under fluoroscopic guidance and retrograde recanalization was performed. Direct revascularization was tried firstly following the angiographic zones, but in failed cases indirect revascularization was carried out with increasing the collateral flow to the wound. Results: Successful direct retrograde revascularization was achieved successfully in 40 patients (78.4%) and indirect revascularization was done in 10 patients (19.6%). Revascularization was failed in one patient (2%). MAE at 2 and 12 months follow-up was 6 (11.7%) and 11 (24%). Limb salvage at 2 and 12 months was 93% and 82.3%, respectively. Balloon angioplasty was performed in all interventions and provisional stenting was done in 34 patients (66.7%). One major and three minor vascular complications occurred after the procedure. The mean basal and control creatinine level was 120.9 6 133.4 and 123.8 6 131.3 lmol/L (P 5 0.83) after the procedure. Conclusion: Failed antegrade attempts to recanalize CTO-s of femoropopliteal and infrapopliteal vessels can be salvaged using a retrograde transpedal access, with a low acute and late complication rate. This technique could be valuable for patients with critical limb ischemia due to femoropopliteal and infrapopliteal occlusions. V
Outcome of Infrainguinal Endovascular Revascularization Procedures for Limb-Threatening Ischemia
Annals of Vascular Surgery, 1995
This report describes the results of 96 infrainguinal endovascular revascularization procedures performed in 86 patients with limb-threatening ischemia over a 3-year period. There were 41 women and 45 men (mean age 72.9 2 11.9 years) including 47 patients (51 .I%) with diabetes and 13 (15.1%) with renal insufficiency. All patients had severe ischemia characterized by rest pain (1 8.8%), ulceration (1 2.5%), or gangrene (68.8%). Twelve procedures were carried out in association with conventional surgical reconstruction and in eight patients with mixed ulcers a venous procedure was performed during the same session. A total of 143 arterial lesions were treated including 61 occlusions (mean length 5.9 -c 3.5 cm) and 82 stenoses (mean length 4.6 f 3 cm). The following techniques were used: transluminal angioplasty in 99 cases, laser in five cases, Rotablator in 24 cases, and aspiration thrombectomy in 15 cases. Nine patients (10.5%) died in the hospital. Initial failure was observed in 32 patients, of whom 18 underwent subsequent surgical revascularization and 14 required amputation of the extremity within 2 months. Analysis of variance was used to assess the following 12 risk factors for initial failure of endovascular revascularization: sex, age, diabetes, renal insufficiency, associated surgery, treatment of multiple lesions, artery treated, type of lesion, length of lesion, quality of runoff, use of an atherotome, and stent placement. Results showed a significant correlation between initial failure and both quality of runoff (12.9% in patients with two or more patent leg arteries vs. 36.5% in patients with one or fewer patent leg arteries; p ~0.05) and type of lesion (14.5% for stenosis vs. 45.9% for occlusion). Mean follow-up was 9.98 2 9.9 months and 4.7% of patients were lost. Restenosis was observed during follow-up of 16 of the 74 initially successful procedures. ANOVA was used to assess the same 12 risk factors for restenosis. Results showed a significant correlation between restenosis and both sex (1 0.8% in women vs. 32.4% in men; p c 0.05) and age (8% for patients > 80 years of age vs. 28.6% for patients c 80 years; p ~0 . 0 5 ) .
Journal of Vascular and Interventional Radiology, 2012
Purpose: To evaluate the technical success and clinical long-term effectiveness of percutaneous transluminal angioplasty (PTA) of the infrapopliteal arteries in critical limb ischemia (CLI) and to determine if total vessel dilation (TVD) increases the limb salvage rate (LSR). Materials and Methods: A retrospective study was performed in 90 consecutive patients (35 men and 55 women, median age 79 years, standard deviation [SD] 9 years) over a 5.5-year period to determine the effectiveness of infrapopliteal PTA in treating CLI. Of 90 patients, 61 underwent TVD. Analysis of LSR was performed using the Kaplan-Meier life-table analysis. Results: In 90 limbs, there were 57 infrapopliteal stenoses and 104 occlusions. Including 10 technical failures (TF) (TF ϭ 11%), LSR at 1 year and 3 years for all 90 patients with previously untreated lesions was 78%. For 80 technically successful (TS) procedures (TS ϭ 89%), LSR at 1 year and 3 years was 87%. At 1 year and 3 years, LSR for the 61 patients who had TVD was 89%. In all patients, there were no amputations after the first year. The 30-day mortality rate was 7%. Conclusions: PTA of the infrapopliteal arteries appears to be an effective treatment for patients with CLI. TVD provides an improved LSR and warrants additional evaluation. ABBREVIATIONS ATK ϭ above the knee, BTK ϭ below the knee, CLI ϭ critical limb ischemia, LSR ϭ limb salvage rate, PTA ϭ percutaneous transluminal angioplasty, SFA ϭ superficial femoral artery, TF ϭ technical failure, TS ϭ technical success, TVD ϭ total vessel dilation From the Department of Radiology (H.O., A.v.d.
Journal of Vascular Surgery, 2012
The adoption of endovascular interventions has been reported to lower amputation rates, but patients who undergo endovascular and open revascularization are not directly comparable. We have adopted an endovascular-first approach but individualize the revascularization technique according to patient characteristics. This study compared characteristics of patients who had endovascular and open procedures and assessed the long-term outcomes. Methods: From December 2002 to September 2010, 433 patients underwent infrainguinal revascularization for critical limb ischemia (CLI; Rutherford IV-VI) of 514 limbs (endovascular: 295 patients, 363 limbs; open: 138 patients, 151 limbs). Patency rates, limb salvage (LS), and survival, as also their predictors, were calculated using Kaplan-Meier and multivariate analysis. Results: The endovascular group was older, with more diabetes, renal insufficiency, and tissue loss. More reconstructions were multilevel (72% vs 39%; P < .001) and the most distal level of intervention was infrapopliteal in the open group (64% vs 49%; P ؍ .001). The 30-day mortality was 2.8% in the endovascular and 6.0% in the open group (P ؍ .079). Mean follow-up was 28.4 ؎23.1 months (0-100). In the endovascular vs open groups, 7% needed open, and 24% needed inflow/runoff endovascular reinterventions with or without thrombolysis vs 6% and 17%. In the endovascular vs open group, 5-year LS was 78% ؎ 3% vs 78% ؎ 4% (P ؍ .992), amputation-free survival was 30% ؎ 3% vs 39% ؎ 5% (P ؍ .227), and survival was 36% ؎ 4% vs 46% ؎ 5% (P ؍ .146). Five-year primary patency (PP), assisted-primary patency (APP), and secondary patency (SP) rates were 50 ؎ 5%, 70 ؎ 5% and 73 ؎ 6% in endovascular, and 48 ؎ 6%, 59 ؎ 6% and 64 ؎ 6% in the open group, respectively (P ؍ .800 for PP, 0.037 for APP, 0.022 for SP). Multivariate analysis identified poor functional capacity (hazard ratio, 3.5 [95% confidence interval, 1.9-6.5]; P < .001), dialysis dependence (2.2 [1.3-3.8]; P ؍ .003), gangrene (2.2 [1.4-3.4]; P < .001), need for infrapopliteal intervention (2.0 [1.2-3.1]; P ؍ .004), and diabetes (1.8 [1.1-3.1]; P ؍ .031) as predictors of limb loss. Poor functional capacity (3.3 [2.4-4.6]; P < .001), coronary artery disease (1.5 [1.1-2.1]; P ؍ .006), and gangrene (1.4 [1.1-1.9]; P ؍ .007) predicted poorer survival. Statin use predicted improved survival (0.6 [0.5-0.8]; P ؍ .001). Need for infrapopliteal interventions predicted poorer PP (0.6 [0.5-0.9-2.2]; P ؍ .007), whereas use of autologous vein predicted better PP (1.8 [1.1-2.9]; P ؍ .017). Conclusions: Patients who undergo endovascular revascularization for CLI are medically higher-risk patients. Those who have bypass have more complex disease and are more likely to require multilevel reconstruction and infrapopliteal intervention. Individualizing revascularization results in optimization of early and late outcomes with acceptable LS, although survival remains low in those with poor health status.
Journal of Vascular Surgery, 2006
This study examined the hypothesis that superficial femoral artery (SFA) subintimal angioplasty (SI-PTA) can maintain limb salvage with minimal complications in patients with symptomatic occlusive arterial disease. Methods: From March 1, 2004, until April 28, 2006, 78 patients with rest pain (62.2%), gangrene (25.6%), or severe progressive claudication (12.2%) were treated consecutively with 82 SFA SI-PTAs (4 bilateral). The mean age was 59 ؎ 1.2 years, and 21 (27%) of the patients were female. All patients were treated in the operating room under local anesthesia by using fluoroscopic guidance, and the percentage SFA that was occluded was measured during the diagnostic portion of the procedure. Selective stent placement was performed after successful recanalization of the occluded arterial segments. Patients were treated with chronic aspirin and clopidogrel bisulfate for 3 months and followed up at 30 days and then every 3 months with physical examination and arterial duplex scan. Results: Of the 82 SFA SI-PTA attempts, 76 (92%) were initially successful, with an increase in the ankle-brachial index from 0.46 ؎ 0.02 to 0.88 ؎ 0.01 (P < .001). Five of the six patients with a failed SFA SI-PTA were female, two of the six had had previous bypass attempts, and one of the six had had a previous SFA SI-PTA attempt by another physician. Forty-nine (64%) of the 76 initially successful SFA SI-PTAs required placement of a stent, and 43 (56.5%) of the successful 76 SFA SI-PTAs required additional PTA of 1 or more arterial segments. The group treated with a successful SFA SI-PTA had 42.5% ؎ 3.5% SFA occlusion, compared with 82% ؎ 10% (P < .05) in the group with a failed attempt at SFA SI-PTA. Two of the six patients with initial SI-PTA failure underwent leg amputation within 30 days, three were treated with successful leg bypass surgery, and one was lost to follow-up. Of the 76 successful SFA SI-PTAs, 5 (6.5%) failed within 90 days, and the patients were treated successfully with leg bypass surgery. Of the 71 limbs with patent SI-PTAs at 90 days, 68 have remained patent with a mean follow-up 10.4 ؎ 0.7 months (range, 2-24 months). Three of the 71 SFA SI-PTAs failed between 4 and 7 months (mean, 5 ؎ 0.7 months): 1 patient was treated with successful bypass surgery, 1 patient is currently considering further intervention, and 1 patient was treated with amputation. Ten (14%) of the 71 successful SFA SI-PTAs required limited PTA for asymptomatic restenosis, as identified by the arterial duplex scan (7.4 ؎ 1.4 months; range, 2-16 months). There were no perioperative deaths, and three patients have died during follow-up with patent SFA SI-PTAs (9.3 ؎ 1.4 months). Conclusions: These data suggest that SFA SI-PTA can be successfully used for limb salvage with minimal morbidity and mortality in a group of patients with severe lower extremity occlusive vascular disease.
Both open surgery and endovascular peripheral interventions have been shown to effectively improve outcomes in patients with peripheral artery disease, but minimal data exist comparing outcomes performed at and below the knee. The purpose of this study was to compare outcomes following infrageniculate lower extremity open bypass (LEB) versus peripheral vascular intervention (PVI) in patients with critical limb ischemia. Using data from the 2008-2014 Vascular Quality Initiative, 1-year primary patency, major amputation, and mortality were compared among all patients undergoing LEB versus PVI at or below the knee for rest pain or tissue loss. Overall, 2566 patients were included (LEB=500, PVI=2066). One-year primary patency was significantly worse following LEB (73% vs 81%; p<0.001). One-year major amputation (14% vs 12%; p=0.18) and mortality (4% vs 6%; p=0.15) were similar regardless of revascularization approach. Multivariable analysis adjusting for baseline differences between groups confirmed inferior primary patency following LEB versus PVI (HR 0.74; 95% CI, 0.60-0.90; p=0.004), but no significant differences in 1-year major amputation (HR 1.06; 95% CI, 0.80-1.40; p=0.67) or mortality (HR 0.71; 95% CI, 0.44-1.14; p=0.16). Based on these data, we conclude that endovascular revascularization is a viable treatment approach for critical limb ischemia resulting from infrageniculate arterial occlusive disease.