Difference In Amputation-free Survival Research Articles

Supra-Inguinal Inflow for Distal Bypasses Have Acceptable Patency and Limb Salvage Rates

There is a paucity of data evaluating outcomes of lower extremity bypass (LEB) using supra-inguinal inflow for revascularization of infra-inguinal vessels. The purpose of this study is to report outcomes after LEB originating from aortoiliac arteries to infra-femoral targets. The Vascular Quality Initiative database (2003-2020) was queried for patients undergoing LEB from the aortoiliac arteries to the popliteal and tibial arteries. Patients were stratified into 3 cohorts based on outflow targets (above-knee [AK] popliteal, below-knee [BK] popliteal, and tibial arteries). Perioperative and 1-year outcomes including primary patency, amputation-free survival (AFS), and major adverse limb events (MALEs) were compared. A Cox proportional hazards model was used to estimate the independent prognostic factors of outcomes. Of 403 LEBs, 389 (96.5%) originated from the external iliac artery, while the remaining used the aorta or common iliac artery as inflow. In terms of the distal target, the AK popliteal was used in 116 (28.8%), the BK popliteal in 151 (27.5%), and tibial vessels in 136 (43.7%) cases. BK popliteal and tibial bypasses, compared to AK popliteal bypasses, were more commonly performed in patients with chronic limb-threatening ischemia (69.5% and 69.9% vs. 48.3%; P<0.001). Vein conduit was more often used for tibial bypass than for AK and BK popliteal bypasses (46.3% vs. 21.9% and 16.3%; P<0.001). In the perioperative period, BK popliteal and tibial bypass patients had higher reoperation rates (16.9% and 13.2% vs. 5.2%; P=0.02) and lower primary patency (89.4% and 89% vs. 95.7%; P=0.04) than AK bypass patients. At 1year, compared with AK popliteal bypasses, BK and tibial bypasses demonstrated lower primary patency (81.9% vs. 56.7% vs. 52.4%, P<0.001) and freedom from MALE (77.6% vs. 70.2% vs. 63.1%, P=0.04), although AFS was not significantly different (89.7% vs. 90.6% vs. 83.8%, P=0.19).On multivariable analysis, compared with AK popliteal bypasses, tibial bypasses were independently associated with increased loss of primary patency (hazard ratio 1.9, 95% confidence interval, 1.03-3.51, P=0.04). Subanalysis of patients with chronic limb-threatening ischemia demonstrated significantly higher primary patency in the AK popliteal cohort at discharge and 1 year, but no difference in AFS or freedom from MALE between the cohorts at follow-up. LEB with supra-inguinal inflow appear to have acceptable rates of 1-year patency and limb salvage in patients at high risk of bypass failure. Tibial outflow target was independently associated with worse primary patency but not with MALE or AFS.

Comparison of Transcatheter Arterialization of Deep Veins to Standard of Care in Patients with No-Option Chronic Limb Threatening Ischemia

Patients with no-option chronic limb-threatening ischemia (no-option CLTI) have limited therapeutic options. The PROMISE II study evaluated, transcatheter arterialization of deep veins (TADV) as a treatment option for no-option CLTI. In the current study patients from PROMISE II were compared to patients from a registry of untreated no-option CLTI patients (CLariTI: Natural Progression of High-Risk Chronic Limb-Threatening Ischemia). We used propensity matching to compare patients from the PROMISE II prospective study of the TADV intervention with simultaneously enrolled CLTI patients that were note candidates for PROMISE II but were enrolled in to CLariTI natural history registry. Untreated no-option CLTI (CLariTI) patients could either be no-option or patients who did not meet PROMISE II entry criteria. Risk difference between groups was calculated using common risk difference and P values were provided by propensity-score stratified Mantel-Haenszel test. The primary endpoint was amputation-free survival (AFS). Diabetes was present in over 75% of patients. All patients had tissue loss and 35-46% had extensive tissue loss (Rutherford 6). The unadjusted AFS at 6months, was 66.1% by Kaplan-Meier estimate for PROMISE II patients (n=105) compared to 39.1% in the no-option cohort of CLariTI (n=121) and 44.0% in the full cohort (no-option and patients not meeting entry criteria combine, n=180). The treatment group who underwent TADV for no-option CLTI had an absolute difference of 29% improved (P<0.0001) propensity-adjusted risk difference in AFS and a relative event rate reduction of 45% compared to the no-option control patients. Transcatheter arterialization of deep veins (TADV) resulted in improved 6month AFS in no-option CLTI patients and appears to be a promising therapy in patients with no-option CLTI.

Arterial dissection during peripheral vascular interventions

ObjectiveArterial dissection (AD) is a known complication of peripheral vascular interventions (PVIs), but its incidence and significance have not been well-characterized. This study examines AD in the Vascular Quality Initiative database for patients treated for peripheral arterial disease. Our hypothesis is that AD is associated with decreased patency and worse limb outcomes. MethodsThe Vascular Quality Initiative PVI registry (2016-2021) was reviewed. Patients were divided based on the presence or absence of reported AD during the procedure. Trend of incidence and management of AD was derived. The characteristics and outcomes of patients with and without AD were compared. The primary endpoint was primary patency. ResultsThere was a total of 177,790 cases, and 3% had AD. The incidence of AD significantly increased over the study period from 2.4% to 3.6% (P = .007). Endovascular therapy was used to treat AD in 83.7% of cases, 14.5% were treated medically, and only 1.8% required open surgery. Patients with AD were significantly more likely to be female (47.4% vs 39.7%; P < .001). Patient with AD were more likely to have a history of smoking (79.7% vs 77.2%; P < .001), but were significantly less likely to be on dialysis (8.2% vs 9.3%; P < .001) compared with patients without AD. Patients with AD were more likely to have femoropopliteal disease (45.2% vs 38.0%; P < .001) and undergo treatment of more complex disease as denoted by higher mean number of lesions treated (1.95 ± 1.01 vs 1.71 ± 0.89; P < .001), longer occlusion length (8 ± 16 vs 7 ± 15 cm; P < .001), and more severe TransAtlantic Inter-Society Consensus grade (Grade D: 36.2% vs 29.1%; P < .001). The proportion of stenting as a treatment modality was higher in the dissection group (55.4% vs 41.1%; P < .001). After a mean follow-up of 828 days, patients with AD had significantly lower primary patency than patients without AD. Kaplan-Meier curves demonstrated that the AD group had lower primary patency (86.9% vs 91%; P < .001) and reintervention-free survival (79.5 % vs 84.1%; P < .001) at 1 year with difference in amputation-free survival. Cox proportional hazard regression confirmed the independent association of AD with primary patency and reintervention-free survival. ConclusionsAD is more common in women and is more likely to occur during treatment of the femoropopliteal segment. AD is associated with decreased primary patency and reintervention-free survival after PVI for peripheral arterial disease.

Bypass surgery versus endovascular revascularization for occlusive infrainguinal peripheral artery disease: a meta-analysis of randomized controlled trials for the development of the Italian Guidelines for the treatment of diabetic foot syndrome.

To report a review and meta-analysis of all randomized controlled trials (RCTs) comparing bypass surgery (BS) and endovascular treatment (ET) in infrainguinal peripheral arterial disease (PAD) for several endpoints, such as major and minor amputation, major adverse limb events (MALEs), ulcer healing, time to healing, and all-cause mortality to support the development of the Italian Guidelines for the Treatment of Diabetic Foot Syndrome (DFS). A MEDLINE and EMBASE search was performed to identify RCTs, published since 1991 up to June 21, 2023, enrolling patients with lower limb ischemia due to atherosclerotic disease (Rutherford I-VI). Any surgical BS or ET was allowed, irrespective of the approach, route, or graft employed, from iliac to below-the-knee district. Primary endpoint was major amputation rate. Secondary endpoints were amputation-free survival major adverse limb events (MALEs), minor amputation rate, all-cause mortality, ulcer healing rate, time to healing, pain, transcutaneous oxygen pressure (TcPO2) or ankle-brachial index (ABI), quality of life, need for a new procedure, periprocedural serious adverse events (SAE; within 30days from the procedure), hospital lenght ofstay, and operative time. Twelve RCTs were included, one enrolled two separate cohorts of patients, and therefore, the studies included in the analyses were 13. Participants treated with ET had a similar rate of major amputations to participants treated with BS (MH-OR 0.85 [0.60, 1.20], p = 0.36); only one trial reported separately data on patients with diabetes (N = 1), showing no significant difference between ET and BS (MH-OR: 0.67 [0.09, 5.13], p = 0.70). For minor amputation, no between-group significant differences were reported: MH-OR for ET vs BS: 0.83 [0.21, 3.30], p = 0.80). No significant difference in amputation-free survival between the two treatment modalities was identified (MH-OR 0.94 [0.59, 1.49], p = 0.80); only one study reported subgroup analyses on diabetes, with a non-statistical trend toward reduction in favor of ET (MH-OR 0.62 [0.37, 1.04], p = 0.07). No significant difference between treatments was found for all-cause mortality (MH-OR for ET vs BS: 0.98 [0.80, 1.21], p = 0.88). A significantly higher rate of MALE was reported in participants treated with ET (MH-OR: 1.44 [1.05, 1.98], p = 0.03); in diabetes subgroup analysis showed no differences between-group for this outcome (MH-OR: 1.34 [0.76, 2.37], p = 0.30). Operative duration and length of hospital stay were significantly shorter for ET (WMD: - 101.53 [- 127.71, - 75.35] min, p < 0.001, and, - 4.15 [- 5.73, - 2.57] days, p < 0.001 =, respectively). ET was associated with a significantly lower risk of any SAE within 30days in comparison with BS (MH-OR: 0.60 [0.42, 0.86], p = 0.006). ET was associated with a significantly higher risk of reintervention (MH-OR: 1.57 [1.10, 2.24], p = 0.01). No significant between-group differences were reported for ulcer healing (MH-OR: 1.19 [0.53, 2.69], p = 0.67), although time to healing was shorter (- 1.00 [0.18, 1.82] months, p = 0.02) with BS. No differences were found in terms of quality of life and pain. ABI at the end of the study was reported by 7 studies showing a significant superiority of BS in comparison with ET (WMD: 0.09[0.02; 0.15] points, p = 0.01). The results of this meta-analysis showed no clear superiority of either ET or BS for the treatment of infrainguinal PAD also in diabetic patients. Further high-quality studies are needed, focusing on clinical outcomes, including pre-planned subgroup analyses on specific categories of patients, such as those with diabetes and detailing multidisciplinary team approach and structured follow-up.

Editor's Choice – Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL) Prospective Cohort Study and the Generalisability of the BASIL-2 Randomised Controlled Trial

The Bypass versus Angioplasty in Severe Ischaemia of the Leg-2 (BASIL-2) randomised controlled trial has shown that, in patients with chronic limb threatening ischaemia (CLTI) who require an infrapopliteal (IP) revascularisation a vein bypass (VB) first revascularisation strategy led to a 35% increased risk of major amputation or death when compared with a best endovascular treatment (BET) first revascularisation strategy. The study aims are to place the BASIL-2 trial within the context of the CLTI patient population as a whole, and to investigate the generalisability of the BASIL-2 outcome data. This was an observational, single centre prospective cohort study. Between 24 June 2014 and 31 July 2018, the BASIL Prospective Cohort Study (PCS) was performed which used BASIL-2 trial case record forms to document the characteristics, initial and subsequent management, and outcomes of 471 consecutive CLTI patients admitted to the vascular centre. Ethical approval was obtained, and all patients provided fully informed written consent. Follow up data were censored on 14 December 2022. Of the 238 patients who required an infrainguinal revascularisation, 75 (32%) had either IP bypass (39 patients) or IP BET (36 patients) outside BASIL-2. Seventeen patients were initially randomised to BASIL-2. A further three patients who did not have an IP revascularisation as their initial management were later randomised in BASIL-2. Therefore, 95/471 (20%) of patients had IP revascularisation (16% outside, 4% inside BASIL-2). Differences in amputation free survival, overall survival, and limb salvage between IP bypass and endovascular revascularisation performed outside BASIL-2 were not subject to hypothesis testing due to the small sample size. Reasons for non-randomisation into the trial were numerous, but often due to anatomical and technical considerations. CLTI patients who required an IP revascularisation procedure and were subsequently randomised into BASIL-2 accounted for a small subset of the CLTI population as a whole. For a wide range of patient, limb, anatomic and operational reasons, most patients in this cohort were deemed unsuitable for randomisation in BASIL-2. The results of BASIL-2 should be interpreted in this context.

P03] Medium Term Outcomes in Patients Undergoing Atherectomy and Antirestenotic Therapy vs. Bypass for Long Infrainguinal In Stent Occlusions

<h3>Objective</h3> The purpose of this study was to report medium term clinical outcomes following atherectomy and antirestenotic therapy (DAART) for in stent occlusions below the inguinal ligament and compare these with femoro-popliteal bypass. <h3>Methods</h3> Data were prospectively collected for all consecutive patients who presented with chronic limb threatening ischaemia and had undergone previous arterial stenting (femoro-popliteal segment) between October 2018 and October 2021 in a single tertiary vascular unit. Outcomes, including amputation free survival, patency, and target lesion revascularisation (TLR), were compared between those having DAART <i>vs</i>. bypass. All patients were entered into a uniform surveillance programme, including three monthly duplex scans. <h3>Results</h3> Of 26 patients, 14 (four female; 28%) underwent DAART <i>vs.</i> 22 who underwent femoro-popliteal bypass (three female; 14%). Lesions were comparable in terms of length of occlusion (19 cm <i>vs.</i> 21 cm, <i>p</i> = .09) and number of occluded stents (two <i>vs.</i> two, <i>p</i> = .44). Severe calcification of target lesions was common and did not differ between groups (65% <i>vs</i>. 63%, <i>p</i> = .19). Over a median follow up of 18 months (range 4 – 36 months), there were no differences in amputation free survival (71% <i>vs</i>. 68%, <i>p</i> = .10) or primary assisted patency (86% <i>vs</i>. 90%). Patients having DAART were more likely to require TLR (42% <i>vs</i>. 32%, <i>p</i> = .01). <h3>Conclusion</h3> This series with prospective uniform follow up including frequent imaging shows that percutaneous DAART for in stent occlusions below the inguinal ligament has promising results, even when compared with bypass. Re-intervention rates, however, are high in both arms, especially those having DAART.

Cancer should not contravene the revascularization of chronic limb-threatening ischaemia.

This study aimed to examine the frequency of cancer among patients with chronic limb-threatening ischaemia (CLTI) due to peripheral artery disease (PAD) and to determine how active cancer affected outcomes after open or endovascular revascularization. In addition, we aimed to investigate all-cause mortality and cause of death in the PAD population. Observational single-centre cohort study based on a retrospective analysis of prospectively entered registry data. All consecutive patients treated for CLTI due to PAD at a single university centre between the 1st of January 2011 and the 31st of December 2015 were included. Data from the Danish Vascular Registry (Karbase) regarding demographics, surgical procedure, and complications were linked with data from the Danish Cancer Registry and Cause of Death Registry. The primary endpoint was major amputation-free survival. Secondary endpoints were postoperative complications within 30 days, cancer-free survival, all-cause mortality and cause of death in the cohort. Major amputation-free survival, cancer-free survival and mortality were described with Kaplan-Meier (KM) survival estimates. We included 920 patients, of which 116 (13%) were in the active cancer group at the time of revascularization. There was no difference in amputation-free survival between those with cancer (86.8% 1-year KM estimate) and those without cancer (85.2% 1-year KM estimate) (p = 0.50). Likewise, we found no difference in 30-day postoperative complication rate. The risk of developing cancer in the included CLTI cohort was similar to the age-matched background population (6.1% vs 6.4%) (p = 0.69). All-cause mortality was higher in CLTI patients with cancer, mainly due to cancer, compared with CLTI patients without cancer who mainly died from cardiovascular disease. Three-year KM survival estimates were 48.3% (95% CI 40.0%-58.3%) and 64.4% (95% CI 61.2%-67.8%) (p = 0.014) for cancer and non-cancer patients, respectively. Although cancer in patients with CLTI is related to higher medium- to long-term mortality, active cancer per se should not contravene revascularization, as postoperative complications and risk of amputation are not overrepresented.

Impact of tibial bypass conduit on long-term amputation-free survival and primary patency in the Vascular Quality Initiative

ObjectiveMuch research remains focused on tibial bypass conduit selection. We sought to describe long-term amputation-free survival (AFS) and primary patency (PP) of patients undergoing tibial bypass by conduit type and configuration across several permutations in the Society for Vascular Surgery Vascular Quality Initiative. MethodsPatients in the Vascular Quality Initiative registry undergoing elective first-time femoral- or popliteal-to-tibial bypass for occlusive disease involving rest pain or tissue loss were identified. Prior ipsilateral infrainguinal bypass or concomitant procedures were excluded. Outcomes of interest included patient AFS at 22 months and PP at 1 year (defined as freedom from revision, thrombectomy, or graft occlusion). ResultsA total of 4192 bypasses were identified. The majority utilized great saphenous vein (GSV) (76.2%), followed by polytetrafluoroethylene (10.6%), nonautologous biologic (6.5%), composite (3.3%), arm vein (2.8%), and small saphenous vein (0.6%). Compared with all prosthetic and composite bypasses, vein grafts had the best AFS (76.4%; P < .0001) and PP (68.1%; P = .041). Of the single segment vein conduits, GSV bypasses had the best PP (69.1%) and arm vein the worst (60.2%). AFS and PP were similar between single-segment GSV orientations. Single-segment GSV bypasses exhibited better PP than multiple segment bypasses (69.1% vs 54.6%; P = .0016). PP was significantly better for polytetrafluoroethylene compared with nonautologous biologic (68.4% vs 51.2%; P = .0039). PP did not significantly differ between vein cuff for prosthetic bypass compared with no vein cuff (69.1% vs 59.7%; P = .091). PP was not significantly different between single-segment GSV and prosthetic grafts with vein cuff (69.1% vs 69.1%; P = .51). There were no significant differences in AFS comparing arm vein, prosthetic bypass with vein cuff, or composite grafts (67.2% vs 63.8% vs 59.3%; P = .092), as well as in PP (60.2% vs 69.1% vs 54.8%; P = .14). ConclusionsSingle-segment vein bypass was only marginally the most optimal conduit. Surprisingly, there may be more equipoise among conduit types, particularly in the absence of adequate GSV. Prosthetic grafts overall may not be as disadvantaged in the long term as initially thought, especially when compared with arm vein, as prosthetic bypass with vein cuff did not significantly differ in PP. Similarly, a composite conduit may not impact long-term outcomes. These data suggest that conduit choice may not impact outcomes to the degree previously thought and that other factors may have a greater impact than presumed, especially in conduit limited situations.

Propensity-matched analysis does not support angiosome-guided revascularization of multilevel peripheral artery disease (PAD).

This retrospective comparative cohort study evaluated the clinical outcome of angiosome-guided endovascular arterial reconstructions in chronic limb-threatening ischemia (CLTI) due to multilevel peripheral artery disease (PAD). Patients treated in an endovascular fashion for CLTI with tissue loss due to multilevel PAD were analyzed. Limbs were classified as having undergone either angiosome-guided (direct) revascularization (DR) or nonangiosomic (indirect) revascularization (IR). DR was defined as uninterrupted in-line flow to the affected angiosome, revascularization through the pedal arch was also considered direct. Groups were adjusted with propensity score (PS) matching and compared for amputation-free survival (AFS), freedom from major adverse limb events (MALE), and healing rate at 12 months. A total of 174 patients (81 men, mean age 70.0 ± 10.4 y) were included. PS matching produced two groups of 55 patients each: DR (24 men, mean age 71.7 ± 10.7 y) and IR (26 men, mean age 72.0 ± 9.4 y). The matched groups had no significant differences in baseline variables. At 12 months there were no significant differences in AFS (73.2% vs 71.6%; p = 0.841), freedom from MALE (71.7% vs 66.1%; p = 0.617), and healing rate (72.7% vs 72.0%; p = 1.000) between DR and IR, respectively. This study failed to support the use of angiosome concept in CLTI due to multilevel disease.

Endovascular versus open repair of isolated superficial femoral and popliteal artery injuries

ObjectiveDespite the increasing use of endovascular therapy for traumatic arterial injuries, little is known about the outcomes of endovascular repair of superficial femoral artery (SFA) and popliteal artery (PA) injuries. In the present study, we compared the characteristics and outcomes of endovascular vs open repair of traumatic SFA and PA injuries. MethodsWe performed a retrospective National Trauma Data Bank analysis of trauma patients with a blunt or penetrating injury of the SFA and/or PA who had undergone endovascular or open repair from 2007 to 2014. Multivariate logistic regression was used to compare the outcomes, with propensity score matching used for sensitivity analysis. ResultsThe incidence of SFA and PA injuries was 0.2%, with an overall increase in the annual use of endovascular stent repair from 3.2% in 2007 to 7.6% in 2014 (P = .002). A total of 2,873 patients with an isolated SFA and/or PA injury were included in the present study, of whom 163 (5.7%) had undergone endovascular repair. SFA injuries were more frequently treated with endovascular repair (70% vs 27%) and PA injuries were more often associated with open repair (41.1% vs 54.7%). Open repair was more frequently associated with a concomitant femur fracture or knee dislocation (30.7% vs 38.8%; P = .039). Endovascular repair was not associated with worse in-hospital amputation-free survival (AFS) compared with open repair on univariate analysis (91.1% vs 89.7%; P = .573) or multivariate logistic regression (odds ratio [OR], 1.053; 95% confidence interval [CI], 0.551-2.012; P = .876). Propensity score matching revealed that in-hospital mortality was higher (OR, 3.69; 95% CI, 1.37-9.82; P = .01) and fasciotomy was lower (OR, 0.23; 95% CI, 0.14-0.37; P < .001) in the endovascular repair group, with no significant differences in AFS (OR, 0.86; 95% CI, 0.48-1.67; P = .65). ConclusionsEndovascular repair of SFA and PA injuries has in-hospital AFS comparable to that for open repair, supporting the increasing use of endovascular repair for traumatic SFA and PA injuries in appropriately selected cases. Given the unexpected finding of increased in-hospital mortality after endovascular repair, further studies are necessary to determine the appropriate patient selection and the durability of endovascular repair.

Outcomes after Endovascular Stent Placement for Long-Segment Superficial Femoral Artery Lesions

Endovascular intervention is commonly pursued as first-line management of symptomatic, long-segment superficial femoral artery (SFA) disease. The relative effectiveness and comparative long-term outcomes among bare metal stents (BMS), covered stents (CS), and drug-eluting stents (DES) for long-segment SFA lesions remain uncertain. A retrospective cohort study identified patients with symptomatic SFA lesions measuring at least 15cm in length who successfully received an endovascular stent (BMS, CS, or DES). The outcomes were patency, patient presentation upon stent occlusion, amputation-free survival (AFS), and all-cause mortality. Proportional hazards regressions and a multinomial logistic regression model were used to control for significant confounders. A total of 226 procedures were analyzed (BMS: 95 [42%]; CS: 74 [33%]; DES: 57 [25%]). There were no significant differences among the 3 stent types with respect to age, prevalence of either diabetes or end-stage renal disease, or smoking history. The median length of the SFA lesion varied across the cohorts (BMS: 28cm [interquartile range, IQR 20-30]; CS: 26cm [IQR 20-30]; DES: 20cm [IQR 16-25]; P=0.002). The unadjusted primary patency of BMS at 12, 24, and 48 month following index stent placement was 57%, 47%, and 44%, respectively. This is compared to 62%, 49%, and 42% for CS, and 81%, 66%, and 53% for DES, respectively (log-rank P=0.044). In adjusted models, however, there were no significant differences in primary patency among the stent types. Compared to CS however, DES was associated with improved primary-assisted patency (hazard ratio [HR] for patency loss: 0.35, P=0.008) and secondary patency (HR: 0.32, P=0.011). Across the entire follow-up period, stent occlusions occurred in 38 (40%) BMS cases, 42 (57%) CS, and 11 (19%) DES (P<0.001). Of these, acute limb ischemia (ALI) occurred in 2 (5%) BMS cases, 14 (33%) CS, and 1 (9%) DES (P=0.010). After adjustment, the relative risk of presenting with ALI as opposed to claudication was 27 times greater among patients re-presenting with occluded CS compared to BMS (P=0.020). There were no significant differences in AFS or all-cause mortality across the 3 cohorts. For long-segment SFA lesions, DES is associated with improved primary-assisted and secondary patency over long-term follow-up. In the event of stent occlusion, CS is associated with an increased risk of ALI.

Endovascular or open surgical treatment of high-risk patients with infrainguinal peripheral arterial disease and critical limb ischemia.

Aim To determine preferable type of treatment in our clinical circumstances by following two groups of patients with critical limb ischemia (CLI), who were treated endovascularly and surgically. Methods Research was carried out in the form of a prospective study of 80 patients with CLI and Trans-Atlantic Inter-Society Consensus (TASC) C or D type of arterial disease, with American Society of Anesthesiology (ASA) class III risk, who were randomly divided in two groups as per the treatment they received, surgical and endovascular. Patients were followed during 28 months using clinical examination and Duplex Ultrasound (DUS) in accordance with prescheduled control visits. Results There was a statistical difference between surgical and endovascular group in two years patency (82.5% vs. 55%; p=0.022) but it did not result in the difference in amputation free survival (AFS) (95% vs. 85%; p=0.171) or two-year freedom from major adverse limb events (MALE) (87.5 vs. 77.5; p=0.254). Also, there was no difference in the overall survival of patients (100% vs. 97.5%; p=0.317). Conclusion Initial endovascular treatment is a preferred form of the treatment for selected patient population.

Amputation-free survival, limb symptom alleviation, and reintervention rates after open and endovascular revascularization of femoropopliteal lesions in patients with chronic limb-threatening ischemia

BackgroundThe optimal strategy for revascularization in chronic limb-threatening ischemia (CLTI) is not yet completely known and is still under debate. Endovascular treatment methods predominate despite limited evidence for their advantage. In this concurrent, prospective observational cohort study, we investigated outcomes after open and endovascular revascularization in the femoropopliteal segment for CLTI. MethodsBetween March 2011 and January 2015, there were 190 patients presenting with CLTI with the principal target lesion in the superficial femoral or popliteal segment who underwent endovascular intervention (n = 117) or bypass surgery (n = 73) and were observed prospectively. The choice of revascularization technique was based on international and local guidelines. All patients were observed for 2 years. The primary end point was amputation-free survival (AFS) assessed with Kaplan-Meier estimates; secondary end points included CLTI symptom alleviation rates and reintervention rates. A Cox proportional hazards regression model was used to investigate risk factors for amputation and death. ResultsAFS at 2 years was 59% in the endovascular group and 76% in the bypass group (P = .020). Kaplan-Meier survival analysis confirmed a significant difference in AFS, with mortality rate as the main driver for the observed intergroup AFS difference. In sequential multivariable regression analysis, the observed difference in AFS between the groups favored bypass surgery and remained significant after controlling for covariates of known prognostic importance (hazard ratio, 2.38; 95% confidence interval, 1.14-4.96). At 2 years, a higher proportion of patients subjected to bypass surgery remained free from ischemic rest pain, wounds, and gangrene (65% vs 45%; P = .009). The proportions of patients who underwent reintervention within 2 years were similar in the two groups (38% vs 39%; P = .90), but repeated reinterventions were more frequent in the bypass group. ConclusionsAt 2 years, bypass surgery was associated with higher AFS than endovascular intervention, a finding that could not be explained only by differences in case mix. More patients who had bypass surgery were free from CLTI symptoms at both 1 year and 2 years after revascularization. Reinterventions to maintain patency were equally common after bypass and endovascular intervention.

Multi-vessel Infra-popliteal Flow to the Foot is Associated with Improved Wound Healing in Patients Undergoing Endovascular Treatment for Critical Limb Ischaemia

Introduction: Infra-popliteal (IP) angioplasty is often considered the first - line treatment option for patients with critical limb Ischaemia (CLI). However disease severity and therefore endovascular practice varies widely, with single vessel infra-popliteal flow being the minimal standard but some evidence favouring multi-vessel flow. We evaluated the effects of both strategies along with foot arch patency on the outcome following endovascular treatment. Methods: We compared outcomes in consecutive patients undergoing IP angioplasty for CLI (Rutherford 4-6) at a single institution. The primary end points were amputation free survival (AFS), limb salvage (LS), and wound healing using Kaplan Meier analysis. Results: Endovascular treatment was completed successfully in 312 patients with tissue loss (mean age 75 years; male 69.2%). Multiple vessel flow (MV) to the foot was achieved in 176 and single vessel (SV) in 136. On completion angiogram, 110 had an occluded foot arch (OA), 146 partial arch (PA) and 56 had a complete arch (CA). AFS was 78% and 57%, and limb salvage was 76% and 67% at 1 and 2 years, respectively. Primary, assisted-primary and secondary patency rates were 69%, 74%, 77% at 1 year and 53%, 57%, 62% at 2years. OA was associated with significantly delayed healing compared with patients with PA and CA (P=0.012 log rank test), but with no significant difference in AFS (P=0.56) or LS (P=0.63). There was no significant difference between the MV and SV groups when comparing wound healing (P=0.09), AFS (P=0.42) or LS (P=0.67). However analysing patients with occluded arch only (OA, N=110), MV was associated with significantly improved wound healing when compared with SV (P=0.02). Conclusion: In patients with an occluded foot arch, multi-vessel infra-popliteal flow is associated with improved wound healing compared to single vessel flow. Patients with an occluded foot arch had poorer healing compared to those with a partial or complete foot arch. Disclosure: Nothing to disclose

Multivessel tibial revascularization does not improve outcomes in patients with critical limb ischemia

ObjectiveMultivessel tibial revascularization for critical limb ischemia (CLI) remains controversial. The purpose of this study was to evaluate single vs multiple tibial vessel interventions in patients with multivessel tibial disease. We hypothesized that there would be no difference in amputation-free survival between the groups. MethodsUsing the Vascular Quality Initiative registry, we reviewed patients undergoing lower extremity endovascular interventions involving the tibial arteries. Patients with CLI were included only if at least two tibial vessels were diseased and adequate perioperative data and clinical follow-up were available for review. The primary outcome was amputation-free survival. ResultsThere were 10,849 CLI patients with multivessel tibial disease evaluated from 2002 to 2017; 761 limbs had adequate data and follow-up available for review. Mean follow-up was 337 ± 62 days. Of these, 473 (62.1%) underwent successful single-vessel tibial intervention (group SV), whereas 288 (37.9%) underwent successful multivessel (two or more) intervention (group MV). Patients in group MV were younger (69.1 vs 73.2 years; P < .001), with higher tobacco use (29.5% vs 18.2%; P < .001). Group SV more commonly had concurrent femoral or popliteal inflow interventions (83.7% vs 78.1%; P = .05). Multivessel runoff on completion was significantly greater for group MV (99.9% vs 39.9%; P < .001). No differences were observed between group SV and group MV for major amputation (9.0% and 7.6%; P = .6), with similar amputation-free survival at 1 year (90.6% vs 92.9%; P = .372). In a multivariate Cox model, loss of patency was the only significant predictor of major amputation (hazard ratio, 5.36 [2.7-10.6]; P = .01). A subgroup analysis of 355 (46.6%) patients with tissue loss data showed that tissue loss before intervention was not predictive of future major amputation. ConclusionsIn the Vascular Quality Initiative registry, patients with CLI and occlusive disease involving multiple tibial vessels did not appear to have a limb salvage benefit from multiple tibial revascularization compared with single tibial revascularization.

P1958Baseline glycated hemoglobin level was differently associated with long-term prognosis in peripheral artery disease patients with and without hemodialysis

Abstract Introduction Diabetes (DM) is the leading cause of induction of hemodialysis (HD), and both are major prognostic factors in patients with peripheral artery disease (PAD). However, the prognostic importance of baseline glycated hemoglobin (HbA1c) levels in PAD patients with and without HD is yet to be elucidated. Purpose We hypothesized that baseline HbA1c levels had different prognostic impacts after endovascular therapy (EVT) in between PAD patients with and those without regular HD. Methods This observational study included 643 consecutive patients who received EVT between 2013 and 2017. Each of 313 HD patients and 330 Non-HD patients was respectively divided into 2 groups by the comorbidity of diabetes, and DM patients were further divided into 3 subgroups depending on HbA1c level at the time of EVT; DM-Low (HbA1c: &lt;6.0%), DM-Mid (6.1–7.0%), and DM-High (&gt;7.1%) groups. The primary endpoint of this study was major amputation-free survival (AFS). Results HD group included significantly more patients presenting critical limb ischemia than Non-HD group (46.6% vs. 30.0%, p&lt;0.001). During the observation period after EVT, there were 81 events (25.9%), including 55 death and 26 major amputations in HD group, and 45 events (13.6%), including 30 death and 15 major amputations in Non-HD group. Kaplan-Meier analysis revealed that DM patients had a significantly higher AFS rate in HD group (Log-rank: p=0.003, Figure A). In contrast, in Non-HD group, there was no statistical difference in AFS between DM and Non-DM patients (p=0.36). In Cox regression analysis in HD group, the higher HbA1c-DM group showed the higher hazard ratio (HR) for AFS (p=0.039, Figure B), and DM patients with HbA1c &gt;6.0% had significantly higher HR than Non-DM patients. Whereas, in Non-HD group, HbA1c-DM class adversely associated with HR for AFS (p=0.003), even any classes did not reach statistical differences from Non-DM patients. Figure 1 Conclusions Comorbidity of diabetes at the time of EVT worsened long-term prognosis in PAD patients receiving regular HD, but not in those without HD. Additionally, baseline HbA1c levels oppositely affected prognosis in PAD patients with and without HD.

Danish Trends in Major Amputation After Vascular Reconstruction in Patients With Peripheral Arterial Disease 2002–2014

Contemporary information on major amputations after revascularisation in Denmark is sparse. This population based national study aimed to determine outcomes following revascularisation for PAD and to identify predictors of major amputation after revascularisation, including geographical variation. Data on patients with PAD undergoing revascularisation (endovascular, open, and hybrid procedures) from 2002 to 2014 were obtained from the Danish Vascular Registry and linked with information from population based healthcare and administrative databases. Cox proportional hazards regression was used to assess the relationship between major amputation and the various associated factors. In all 25,982 first time vascular reconstructions for PAD were performed between 2002 and 2014 and major amputations were performed in 2883 (11.1%) of the patients. The total number of revascularisations increased up to 2010 and thereafter numbers decreased slightly. A trend towards endovascular revascularisation as first time revascularisation was seen (36.6% in 2002 vs. 59.0% in 2014, p < .001). Median time from first revascularisation to major amputation was 4.66 months (range 0.03–146.88 months), and 63.1% of major amputations were performed within one year following revascularisation. No change in the number of amputations performed within one year after revascularisation was found during the study (p = .251). The strongest predictor for major amputations was ulcers/gangrene (HR 8.06, CI 7.11–9.13, p< .001) at the time of revascularisation. Geographic variation for intensity of revascularisation was observed and geographic differences in amputation free survival for patients with intermittent claudication and ulcers/gangrene were found. Although more patients with PAD undergo revascularisation, one in 10 still ends up with a major amputation of the lower limb. The risk of amputation was highly associated with the severity of the vascular disease at the time of revascularisation, with ulcers/gangrene as the strongest predictor. Geographic differences in vascular treatment intensity were found, but these failed to explain the differences in risk of major amputation after revascularisation across catchment areas.

Gene therapy for peripheral arterial disease.

Reason for Withdrawal This protocol was withdrawn from the Cochrane Library from Issue 3, 2015 as no progress had been made towards the review. To view the published versions of this article, please click the ‘Version History' tab. To view the published versions of this article, please click the 'Other versions' tab.

Danish Trends in Major Amputation After Vascular Reconstruction in Patients With Peripheral Arterial Disease 2002–2014

Contemporary information on major amputations after revascularisation in Denmark is sparse. This population based national study aimed to determine outcomes following revascularisation for PAD and to identify predictors of major amputation after revascularisation, including geographical variation. Data on patients with PAD undergoing revascularisation (endovascular, open, and hybrid procedures) from 2002 to 2014 were obtained from the Danish Vascular Registry and linked with information from population based healthcare and administrative databases. Cox proportional hazards regression was used to assess the relationship between major amputation and the various associated factors. In all 25,982 first time vascular reconstructions for PAD were performed between 2002 and 2014 and major amputations were performed in 2883 (11.1%) of the patients. The total number of revascularisations increased up to 2010 and thereafter numbers decreased slightly. A trend towards endovascular revascularisation as first time revascularisation was seen (36.6% in 2002 vs. 59.0% in 2014, p<.001). Median time from first revascularisation to major amputation was 4.66 months (range 0.03-146.88 months), and 63.1% of major amputations were performed within one year following revascularisation. No change in the number of amputations performed within one year after revascularisation was found during the study (p=.251). The strongest predictor for major amputations was ulcers/gangrene (HR 8.06, CI 7.11-9.13, p<.001) at the time of revascularisation. Geographic variation for intensity of revascularisation was observed and geographic differences in amputation free survival for patients with intermittent claudication and ulcers/gangrene were found. Although more patients with PAD undergo revascularisation, one in 10 still ends up with a major amputation of the lower limb. The risk of amputation was highly associated with the severity of the vascular disease at the time of revascularisation, with ulcers/gangrene as the strongest predictor. Geographic differences in vascular treatment intensity were found, but these failed to explain the differences in risk of major amputation after revascularisation across catchment areas.

Functional prognosis of critical limb ischemia and efficacy of restoration of direct flow below the ankle

Patients with critical limb ischemia have serious systemic comorbidities and are at high risk of impairment of limb function. In this study, we assessed the prognostic factors of limbs after revascularization. In this retrospective single-center cohort study, from April 2008 to December 2012, we treated 154 limbs of 121 patients with critical limb ischemia by the endovascular therapy-first approach based on the patients' characteristics. The primary end point was amputation-free survival. Secondary end points were patency of a revascularized artery, major adverse limb events, or death. Furthermore, we investigated the ambulatory status one year after revascularization as prognosis of limb function. Endovascular therapy was performed in 85 limbs in 65 patients as the initial therapy (endovascular therapy group) and surgical reconstructive procedures (bypass group) were performed in 69 limbs in 56 patients. Early mortality within 30 days was not observed in either group. The primary patency rate was significantly better in the bypass group than in the endovascular therapy group ( p < 0.0001). Furthermore, the secondary patency rate was similar between the two groups ( p = 0.0096). There were no significant differences in amputation-free survival and major adverse limb event between the two groups. Univariate analysis showed that ulcer healing ( p < 0.0001), no hypoalbuminemia ( p = 0.0019), restoration of direct flow below the ankle ( p = 0.0219), no previous cerebrovascular disease ( p = 0.0389), and Rutherford 4 ( p = 0.0469) were predictive factors for preservation of ambulatory status one year after revascularization. In multivariate analysis, ulcer healing ( p < 0.0001) and restoration of direct flow below the ankle ( p = 0.0060) were significant predictors. Ulcer healing and restoration of direct flow below the ankle are independently associated with prognosis of limb functions in patients who undergo infrainguinal arterial reconstruction.