Revascularization For Critical Limb Ischemia Research Articles

Comparative Outcomes of Targeted Versus Nontargeted Angiosome Revascularization for Diabetic Foot Wounds Impact of Target Arterial Path on Wound Healing

Diabetes is strongly correlated with the development of critical limb ischemia (CLI), with a predilection for below-the-knee and below-the-ankle patterns of arterial disease. The angiosome concept, described as a potential framework for targeted revascularization in CLI, has generated divergent opinions over the last decades. This study aims to evaluate the implication of angiosome targeted revascularization in wound healing in diabetic patients. This is a single-center retrospective study including diabetic patients with ischemic ulcers admitted for invasive vascular study and revascularization between January and December 2019. The primary outcome was to evaluate the impact of angiosome-targeted revascularization in wound healing. Limb-based patency and amputation-free survival according to GLASS stage and revascularization procedures were considered secondary outcomes. Data from 117 limbs of 114 diabetic patients with neuroischemic diabetic foot were evaluated. There was no significant difference between targeted and non-targeted angiosome-revascularization in wound healing at 12 months. However, angiosome targeted revascularization was associated with shorter healing times. The severity of the infection was the only variable with an impact on healing time. Endovascular surgery did not show inferior patency to open surgery, even in patients with more complex arterial disease (GLASS III). Although angiosome-guided revascularization did not demonstrate significantly higher healing rates at 12 months, there appears to be a trend towards faster healing.

Racial and Ethnic Disparities in Treatment of Critical Limb Ischemia: A National Perspective.

Background Recent guidelines have emphasized the use of medical management, early diagnosis, and a multidisciplinary team to effectively treat patients with critical limb ischemia (CLI). Previous literature briefly highlighted the current racial disparities in its intervention. Herein, we analyze the trend over a 14-year time period to investigate whether the disparities gap in CLI management is closing. Methods and Results The National Inpatient Sample was queried between 2005 and 2018 for hospitalizations involving CLI. Nontraumatic amputations and revascularization were identified. Utilization trends of these procedures were compared between races (White, Black, Hispanic, Asian and Pacific Islander, Native American, and Other). Multivariable regression assessed differences in race regarding procedure usage. There were 6 904 562 admissions involving CLI in the 14-year study period. The rate of admissions in White patients who received any revascularization decreased by 0.23% (P<0.001) and decreased by 0.25% (P=0.025) for Asian and Pacific Islander patients. Among all patients, the annual rate of admission in White patients who received any amputation increased by 0.21% (P<0.001), increased by 0.19% (P=0.001) for Hispanic patients, and increased by 0.19% (P=0.012) for the Other race patients. Admissions involving Black, Hispanic, Asian and Pacific Islander, or Other race patients had higher odds of receiving any revascularization compared with White patients. All races had higher odds of receiving major amputation compared with White patients. Conclusions Our analysis highlights disparities in CLI treatment in our nationally representative sample. Non-White patients are more likely to receive invasive treatments, including major amputations and revascularization for CLI, compared with White patients.

Endovascular revascularization of critical limb ischemia: the role of ultrasound-guided popliteal sciatic nerve block for the procedural pain management.

To evaluate the impact of the ultrasound-guided popliteal sciatic nerve block (PSNB) for pain management during endovascular treatment of chronic limb-threatening ischemia (CLTI). From November 2020 to January 2022, 111 CLTI patients that underwent endovascular procedures were prospectively enrolled in this prospective single-arm interventional study. Ultrasound-guided PSNB was used for procedural pain control. Pain intensity was evaluated throughout the procedure (baseline, 10min after the block, pain peak, and at the end of the procedure) with the visual analog scale (VAS). Forty-six patients underwent above-the-knee revascularization (ATK), 20/111 below-the-knee (BTK) revascularization, 20/111 to both ATK and BTK revascularization. In 25 cases, no endovascular option was feasible at diagnostic angiography. The PSNB was effective in 96% of patients, with no need for further pain management with a statistically significant reduction (p < 0.0001) in the mean value of the VAS from 7.86 ± 1.81 (pre-procedural) to 2.04 ± 2.20 after 10min from the block and up to 0.74 ± 1.43 at the end of the procedure (mean time 43min). Only 1 complication related to the popliteal sciatic nerve block was registered (a temporary foot drop, completely resolved within 48h). The time necessary to perform the block ranged between 4 and 10min. Ultrasound-guided PSNB is a feasible and effective method to manage patients with rest pain and increase comfort and compliance during endovascular procedures. An ultrasound-guided popliteal sciatic nerve block is a safe, feasible, and effective technique to manage pain during endovascular treatment of chronic limb-threatening ischemia, especially in frail patients with multiple comorbidities who are poor candidates for deep sedoanalgesia or general anesthesia. Endovascular treatment of CTLI may require long revascularization sessions in patients with high levels of pain at rest, which could be exacerbated during the revascularization procedure. The PSNB is routinely used for anesthesia and analgesia during foot and ankle surgery, but the experience with lower limb revascularization procedures is very limited and not included in any international guideline. Ultrasound-guided PSNB is a feasible and effective regional anesthesia technique to relieve procedural and resting pain. Because of its safety and availability, every interventional radiologist should know how to perform this type of loco-regional anesthesia.

Successful Crossover Bypass Using a Lateral Femoral Circumflex Artery as an Outflow Vessel for Indirect Revascularization in Critical Limb Ischemia: A Case Report.

A 78-year-old man presented with severe stage 3 (Fontaine IV, Rutherford 5, W1 I3 FI0) right limb ischemia. Although his artery was completely occluded from below the right external iliac to the popliteal artery, collateral circulation from the right lateral femoral circumflex artery was well developed and supplied the lower extremity arteries. We selected an uncommon crossover bypass strategy with the left common femoral artery to the right lateral femoral circumflex artery to improve lower extremity perfusion via indirect revascularization. Bypass using the lateral femoral circumflex artery as an outflow is an option for patients with major lower extremity artery occlusions.

Tissue Perfusion Changes after Direct and Indirect Angiosome Revascularization in Critical Limb Ischemia

Background. Blood flow restore in critical limb ischemia according to angiosomes is becoming very popular. This method allows to restore blood flow precisely to the artery supplying the ischemic zone, based on the angiosome concept. However, angiosome revascularization is not a gold standard because of the lack of evidence supporting this approach. The aim of this study was to compare tissue oxygenation changes in ischemic zone during endovascular revascularization procedure either following angiosome concept or performing indirect revascularization. Methods. A prospective observational study was performed. Patients with critical limb ischemia and tissue loss due to chronic total occlusion of below the knee arteries were included. Endovascular revascularization was performed in all cases. Tissue oxygen saturation was observed intraoperatively using near-infrared spectroscopy. Tissue oxygenation changes near the ischemic wound were compared between direct and indirect revascularization groups. Results. This clinical trial included 30 patients with critical limb ischemia (Rutherford 5) and occluded below the knee arteries intended to treat. In 15 patients the procedure was performed according to angiosome, while the other half underwent indirect revascularization. Tissue oxygenation near the wound was monitored during the intervention. Greater oxygen saturation increase was observed in the group with direct revascularization (29% and 23% accordingly), however the difference between groups was not statistically significant (t-test for independent group, p = 0,544). Conclusions. The increase in tissue oxygen saturation differed very slightly in direct and indirect revascularization groups and the difference was statistically insignificant.

Major adverse limb events in patients with femoro-popliteal and below-the-knee peripheral arterial disease treated with either sirolimus-coated balloon or standard uncoated balloon angioplasty: a structured protocol summary of the \u201cSirPAD\u201d randomized controlled trial

BackgroundPeripheral arterial disease is a progressive atherosclerotic disease with symptoms ranging from an intermittent claudication to acute critical limb ischemia and amputations. Drug-coated balloons and stents were developed to prevent neo-intimal proliferation and restenosis after percutaneous transluminal angioplasty. Randomized controlled trials showed that drug-coated, notably paclitaxel-coated, devices reduce restenosis, late lumen loss, and the need for target lesion re-vascularization compared with uncoated ones. However, the size of these trials was too small to prove superiority for “hard” clinical outcomes. Moreover, available studies were characterized by too restrictive eligibility criteria. Finally, it remains unclear whether paclitaxel-coated balloons may impair long-term survival. Alternative drug-coated balloons, the so-called limus-based analogs, have been approved for clinical use in patients with peripheral arterial disease. By encapsulating sirolimus in phospholipid drug nanocarriers, they optimize adhesion properties of sirolimus and provide better bioavailability.MethodsIn this investigator-initiated all-comer open-label phase III randomized controlled trial, we will evaluate whether sirolimus-coated balloon angioplasty is non-inferior and eventually superior, according to a predefined hierarchical analysis, to uncoated balloon angioplasty in adults with infra-inguinal peripheral arterial disease requiring endovascular angioplasty. Key exclusion criteria are pregnancy or breastfeeding, known intolerance or allergy to sirolimus, and participation in a clinical trial during the previous 3 months. The primary efficacy outcome is the composite of two clinically relevant non-subjective “hard” outcomes: unplanned major amputation of the target limb and endovascular or surgical target lesion re-vascularization for critical limb ischemia occurring within 1 year of randomization. The primary safety outcome includes death from all causes.DiscussionBy focusing on clinically relevant outcomes, this study will provide useful information on the efficacy and safety of sirolimus-coated balloon catheters for infra-inguinal peripheral arterial disease in a representative (“all-comer”) population of unselected patients. As regulatory agencies had raised safety concerns in patients exposed to paclitaxel-coated devices (versus uncoated ones), collect mortality data up to 5 years after randomization will be collected.Trial registrationClinicalTrials.govNCT04238546

Fresh Cold-Stored Vascular Allografts in Subgenicular Location: Our Experience with Rescue Endovascular Techniques

Critical limb ischemia (CLI) is considered the most severe pattern of peripheral artery disease. CLI is associated with high rates of morbidity and mortality with high risk of limb amputation. In the absence of appropriate autologous grafts, unsuitability of prosthetic bypasses, and endovascular methods, fresh cold-stored venous allografts is an option. Endovascular interventional methods are essential methods for maintaining primary and secondary patency. A single-centre retrospective analysis of 82 surgical revascularizations using allogeneic vascular grafts and rescue endovascular techniques restoring and maintaining the patency of these allogeneic revascularizations in the period between July 2005 and July2021. We have performed 82 allogeneic revascularizations in 75 patients (52 reconstructions in men/63.4%/, 30 reconstructions in women/36.6%/). The median age of patients was 68years (49min, 87 max). We subsequently had to intervene a total of 26 bypasses. We intervened in 30 acute occluded allogeneic bypass grafts and 9 failing stenotic bypass grafts. We performed 52 angiographies. The success rate of rescue endovascular procedures in primary allogeneic reconstruction with distal anastomosis to the popliteal artery is statistically significant (P<0.02) compared to procedures with distal anastomosis to the tibial and pedal bed. The cumulative patency (primary at time) of allogeneic reconstructions in our group was 89% after 1month, 51.9% after 12months, 24.2% after 3years, 9.8% after 5years. Limb salvage was 72.6% in 1year, 53% in 3years, 36.5% in 5years, respectively. Cold-stored venous allografts may be used for performing below-the-knee revascularization for CLI with acceptable results, despite the poor long-term patency. Rescue endovascular techniques are an essential method for restoring or maintaining the patency of these reconstructions. These techniques have a high success rate and no other alternative.

Rates of Conversion from Dry to Wet Gangrene Following Lower Extremity Revascularization

There is a paucity of data regarding the conversion rate from dry gangrene to wet gangrene after lower extremity revascularization. This study aimed to determine the rate of conversion from dry to wet gangrene within 30 days post-procedure in patients who underwent endovascular or open revascularization for critical limb ischemia. Secondary aims included determining the time to conversion and associated risk factors with conversion. A multicenter, retrospective review was performed utilizing the MGH/Brigham Healthcare System's Research Patient Data Registry (RPDR). All adult patients who had lower extremity dry gangrene that underwent a revascularization procedure (endo, open, hybrid) from April 2002 to March 2020 were included. Patients who had no lower extremity gangrene, a concurrent amputation with the revascularization procedure, or wet gangrene on initial presentation were excluded. Univariate analysis was performed using the Fisher's exact test and Wilcoxon rank-sum test. There were 1,518 patients identified who underwent revascularization; 194 (12.8%) patients met inclusion criteria and served as our study cohort. There were 15 (7.7%) conversions from dry to wet gangrene within 30 days post-procedure. The mean time to conversion was 13.5 ± 8.6 days. Univariate analysis did not identify any associated risk factors for conversion. The rate of dry to wet gangrene conversion post revascularization is 7.7% within 30 days. The mean time of conversion is 13.5 ± 8.6 days.

Impact of Hospital Procedural Volume on Outcomes After Endovascular Revascularization for Critical Limb Ischemia

The aim of this study was to evaluate the interaction between hospital endovascular lower extremity revascularization (eLER) volume and outcomes after eLER for critical limb ischemia (CLI).There is a paucity of data on the relationship between hospital procedural volume and outcomes of eLER for CLI.The authors queried the Nationwide Readmission Database (2013-2015) for hospitalized patients who underwent eLER for CLI. Hospitals were divided into tertiles according to annual eLER volume: low volume (<100 eLER procedures), moderate volume (100-550 eLER procedures), and high volume (>550 eLER procedures). Stepwise multivariable regression models were used. The main outcomes were in-hospital mortality and 30-day readmission with major adverse limb events, defined as the composite of amputation, acute limb ischemia, or repeat revascularization.Among 145,785 hospitalizations for eLER for CLI, 5,199 (3.6%) were at low-volume eLER hospitals, 27,857 (19.1%) at moderate-volume eLER hospitals, and 112,728 (77.3%) at high-volume eLER hospitals. On multivariable analysis, there was no difference with regard to in-hospital mortality among moderate-volume hospitals (adjusted odds ratio [OR]: 0.78; 95% CI: 0.60-1.01) and high-volume hospitals (adjusted OR: 0.84; 95% CI: 0.64-1.05) compared with low-volume hospitals. There was lower risk of in-hospital major amputation (adjusted OR: 0.82; 95% CI: 0.70-0.96) and minor amputation at high- versus low-volume hospitals. The length of hospital stay was shorter and discharges to nursing facilities were fewer among moderate- and high-volume hospitals compared with low-volume hospitals. Compared with low-volume hospitals, eLER for CLI at high-volume hospitals had a lower risk for 30-day readmission with major adverse limb events (adjusted OR: 0.83; 95% CI: 0.70-0.99), while there was no difference among moderate-volume hospitals (adjusted OR: 0.92; 95% CI: 0.77-1.10).This nationwide observational analysis suggests that annual eLER volume does not influence in-hospital mortality after eLER for CLI. However, high eLER volume (>550 eLER procedures) was associated with better rates of limb preservation after eLER for CLI.

Outcomes with Aspirin and Clopidogrel Versus Aspirin and Rivaroxaban in Infrainguinal Endovascular Revascularization for Critical Limb Ischemia

Background: The purpose of the study was to assess the benefits of dual antithrombotic therapy in the management of peripheral arterial disease in Indian population. Methods: We conducted a prospective review of patients on dual antithrombotic therapy who underwent infra-inguinal endovascular revascularisation at JIVAS for 18 months. Objectives: To study the outcomes with aspirin + clopidogrel (CA) versus aspirin + rivaroxaban (RA) after infrainguinal endovascular revascularization for critical limb ischemia. The main objective was to assess primary patency of vessel after endovascular revascularization. The secondary objectives were to study limb salvage, major adverse limb events (MALEs), major adverse cardiac events (MACEs), bleeding events (major and minor), and wound healing. Results: In the present study, a total of 104 patients underwent infrainguinal revascularization and fulfilled the inclusion criteria, of which 48 received RA and 56 received CA. The mean age was 49.8 years with no significant differences in the baseline demographics and comorbidities between the two groups. The primary objective of vessel patency was assessed measuring the ankle brachial index which was 0.91 in the RA group and 0.96 in the CA group and remained the same on follow-up till 6 months and mean trans cutaneous oxygen pressure of around 34 in both the groups. There was no significant difference in the incidence of MALE (2.1% in RA vs. 7.1% in CA;P= 0.2), MACE (6.3% in RA vs. 10.7% in CA;P= 0.4), wound healing (81% RA vs. 75% CA;P= 0.4), safety parameter of bleeding (6.3% RA vs. 3.6% CA), creatinine, and liver function tests (LFT) during the study period. Conclusion: Both the antithrombotic regimens can be considered safe and efficacious in the postoperative management of patients undergoing infrainguinal revascularization; with maintenance of primary patency, comparable wound healing, incidence of MALE and MACE, and safe with no bleeding; and no impairment in the serum creatinine and LFTs during follow-up.

Anxiety and Depression Scores in Patients Subjected to Arterial Revascularization for Critical Limb Ischemia

This study aims to examine the changes in anxiety and depression scores in 138 patients with critical limb ischemia (rest pain or gangrene) who had no previous psychiatric history, at 30 days and 6 months after surgical revascularization. Patients were submitted to a questionnaire-based evaluation using the Beck Anxiety and Depression Inventories before surgery (no more than three days before surgery) ("Pre-Op"), 30 days after surgical revascularization ("Early PO") and at least 6 months after surgical revascularization ("Late PO"). The cut-off scores for depression were (1) < 10, no depression or minimal depression; (2) 10‒18, mild to moderate depression; (3) 19‒29, moderate to severe depression; and (4) 30‒63, severe depression. The cut-off scores for anxiety were (1) < 8, no anxiety or minimal anxiety; (2) 8‒15, mild anxiety; (3) 16‒25, moderate anxiety; and (4) 26‒63, severe anxiety. No perioperative mortality was observed 30 days after surgical revascularization. Thirty-nine (28.2%) patients underwent major (above-ankle) amputation within 30 days. Mean anxiety and depression scores, respectively, declined from 12.48 ± 9.74 (mean ± SD) and 16.92 ± 12.48 preoperatively to 4.89 ± 7.04 and 6.52 ± 9.36 postoperatively (P<0.001, both). Anxiety and depression scores were not significantly affected by preoperative comorbidities (systemic arterial hypertension, diabetes mellitus, previous stroke, and smoking), affected arterial territory (aortoiliac, femoropopliteal, or infrapopliteal), or surgical technique (open surgery vs endovascular therapy). Only patients undergoing amputation within 30 days showed no improvement in depressive symptoms. Patients with critical limb ischemia have a high incidence of anxiety and depressive symptoms, which improve considerably after successful surgical revascularization. Major amputation was associated with a lack of improvement in depression scores. A formal psychiatric evaluation may be beneficial in patients who show no improvement in depressive symptoms.

Early outcomes of patients with chronic kidney disease after revascularization for critical limb ischemia.

The aim of this study was to report early outcomes of patients with non-dialysis-dependent chronic kidney disease (NDD-CKD) after revascularization for critical limb-threatening ischemia (CLTI). Perioperative data of patients from the CRITISCH (critical limb ischemia) Registry, who also had NDD-CKD (stages 3 and 4), were compared to their counterparts with normal renal function (NRF) or mild renal insufficiency (stages 1 and 2). Patient characteristics and type of first-line treatment were assessed. Amputation-free survival was the primary composite endpoint. Secondary endpoints included major adverse cardiovascular and cerebral events (MACCE) and hemodynamic failure of revascularization. Multivariable logistic regression determined risk factors for the endpoints. 424 patients with NDD-CKD were identified. Endovascular revascularization (ER) was performed in 251 patients (59.2%). Eighty-six patients (20.3%) underwent bypass surgery (BS) and 29 patients (6.8%) femoral artery patchplasty (FAP). Conservative treatment (CT) was offered to 46 patients (10.9%); 12 patients (2.8%) underwent primary major amputation (PMA). Logistic regression analysis showed an increased early risk for amputation/death (OR=1.92, 95% CI: 1.09-3.40), death (OR=5.53, 95% CI: 1.92-15.90) and hemodynamic failure of the revascularization (OR=1.80, 95% CI: 1.19-2.72) compared to patients with NRF. Patients with NDD-CKD also seem to carry a higher risk for MACCE (OR=1.82, 95% CI: 0.99-3.36). NDD-CKD was not a risk factor for limb loss alone (OR=1.05, 95% CI: 0.49-2.22). NDD-CKD was an independent risk factor for early postoperative mortality, morbidity and reduced patency, but not for limb loss. Robust follow-up is necessary to monitor for such events, as well as to prevent readmission.

Low admission blood pressure as a marker of poor 1-year survival in patients with revascularized critical limb ischemia.

To contrast the association between blood pressure (BP) level and antihypertensive medications at hospital admission with 1-year mortality in patients undergoing revascularization for critical limb ischemia (CLI). From November 2013 to May 2019, 315 consecutive patients were retrospectively included. A median of seven (IQR 3-13) separate readings were recorded for each patient before revascularization procedure and the average represented patient's mean BP. BP-lowering medications, clinical and biological parameters were recorded at baseline. The main outcome was total 1-year mortality. The cohort included 172 men (55%) and 143 women (45%), with a mean age of 77.9 ± 11.9 years. Treated hypertension was present in 245 (78%) patients; 288 (91%) patients had BP-lowering drug prescriptions (2.1 ± 1.3 medications at baseline). Mean SBP, DBP, mean BP (MBP) and pulse pressure (PP) were 132 ± 18, 70 ± 8, 90 ± 10 and 62 ± 16mmHg. During 1-year follow-up, 80 (25.4%) patients died. In single-pressure multivariate analysis, SBP (hazard ratio 0.97; 95% CI 0.96-0.99; P = 0.005), MBP (hazard ratio 0.96; 95% CI 0.92-0.99; P = 0.01), PP (hazard ratio 0.97; 95% CI 0.95-0.99; P = 0.009), but not DBP, were inversely correlated with 1-year mortality, independently of age, coronary heart disease, left ventricular ejection fraction, brain natriuretic peptide, serum albumin, institutionalized status and antihypertensive drugs. Association between SBP, MBP and PP with 1-year mortality had a quite linear reverse pattern. Among patients undergoing revascularization for CLI, there is an inverse correlation between admission SBP, MBP and PP with 1-year mortality. BP may represent a modifiable therapeutic target to prevent poor outcome in CLI patients.

Contemporary Revascularization Strategies and Outcomes Among Patients With Diabetes With Critical Limb Ischemia: Insights From the National Inpatient Sample.

The purpose of this study was to evaluate temporal trends in the frequency of revascularization and associated outcomes in patients with diabetes mellitus and critical limb ischemia (CLI). Little is known about outcomes following revascularization for CLI in patients with diabetes mellitus. Temporal trends in hospitalization for CLI among patients with diabetes were determined using the 2002-2015 National Inpatient Sample database. Propensity score matching was used to compare patients who underwent revascularization with those who did not and, separately, to compare those who underwent endovascular versus surgical revascularization. The main study outcome was in-hospital mortality. The analysis included 1,222,324 hospitalizations. The number of hospitalizations for CLI among patients with diabetes increased over time (ptrend< 0.001). There was an increase in the use of lower extremity revascularization, paralleled by a decline in in-hospital mortality during the study period. In the matched cohort, patients who were revascularized had lower in-hospital mortality (odds ratio [OR]: 0.68; 95% confidence interval [CI]: 0.63 to 0.72) and major amputation (OR: 0.25; 95%CI: 0.24 to 0.27) compared with those who were treated medically. Compared with endovascular revascularization, those who underwent surgical revascularization had higher rates of in-hospital mortality (OR: 1.18; 95%CI: 1.04 to 1.35) but lower rates of major amputation (OR: 0.75; 95%CI: 0.70 to 0.81). Major bleeding, blood transfusion, post-operative infection, respiratory complications, discharges to nursing facility, and longer length of hospital stay were also more common among those who underwent surgery. In this national analysis of patients with DM and CLI, we demonstrated an increase in hospitalization for CLI among patients with diabetes in the United States. Although in-hospital mortality decreased over time regardless of the treatment strategy used, this outcome occurred less frequently among those who underwent revascularization than not. Compared with surgical revascularization, endovascular revascularization was associated with lower in-hospital mortality but higher rates of major amputation.

Predictive value of admission blood pressure for 3-month mortality in patients undergoing revascularization for critical limb ischemia.

In patients with critical limb ischemia (CLI), blood pressure (BP) impact on mortality is unknown. We analyzed the predictive value of SBP, DBP and pulse pressure (PP) at hospital admission on 3-month mortality in patients with CLI undergoing revascularization procedure. From November 2013 to December 2018, 297 consecutive patients were retrospectively included. Admission BP was recorded using automated brachial sphygmomanometer, before revascularization procedure. A median of seven (IQR3-13) separate readings were recorded for each patient and the average represented patient's mean BP (mBP). Clinical and biological parameters were recorded at baseline. The cohort included 163 men (55%) and 134 women (45%) with a mean age of 77.7 ± 11.9 years. Treated hypertension and diabetes were present in, respectively, 62 and 48% of patients. Mean SBP, DBP and PP were 132 ± 18, 70 ± 8 and 62 ± 16 mmHg. Thirty-four patients (11.4%) died during 3-month follow-up, mostly from cardiovascular causes. In univariate analysis, age, female sex, brain natriuretic peptide and C-reactive protein were positively correlated with mortality. BMI, mSBP, mDBP, mPP, hemoglobin, serum albumin and statin treatment were negatively correlated with mortality. In single-pressure multivariate analyses, mSBP (P = 0.024) and mPP (P = 0.030) were negatively correlated with mortality. Association between mSBP and mortality had an asymptotic curve pattern and SBP level 135 mmHg or less was significantly correlated with mortality. In patients undergoing revascularization for CLI, admission SBP is an independent predictor for short-term mortality with a negative relationship. SBP level 135 mmHg or less represents a warning sign to explore and correct associated comorbidities.

Gender Disparities in Presentation, Treatment, and Outcomes of Critical Limb Ischemia

Women with peripheral artery disease (PAD) experience higher rates of functional decline and may have worse clinical outcomes after invasive treatment for PAD compared to men. Despite this, women remain under-represented in contemporary PAD studies. We aim to use National Surgical Quality Improvement Program data to better understand differences in presentation, treatment, and short-term outcomes for women compared to men undergoing lower extremity (LE) revascularization for critical limb ischemia (CLI). We included 2018 patients. The National Surgical Quality Improvement Program database includes 30-day outcomes for inpatient operations at participating hospitals. Descriptive statistics and multivariable analyses were performed. There were a total of 32,902 LE interventions, of which 22,111 (67%) were for patients with CLI (rest pain or tissue loss). Women were significantly more likely to have CLI on presentation (71% vs 65%; P < .001) compared to men. In the cohort of patients undergoing LE intervention for CLI, women were more likely to be older (mean, 70 ± 12 years vs 68 ± 11 years; P < .001), black (25% vs 18%; P < .001), and hypertensive (86% vs 82%; P < .001), and less likely to be smokers (31% vs 38%; P < .001), on a statin medication (69% vs 71%; P < .001), or functionally independent (84% vs 89%; P < .001). Women were more likely to have a preoperative ankle-brachial index of <0.4 (20% vs 16%; P < .001) compared to men (Table I). Women with CLI were more likely to undergo endovascular intervention compared to men (44% vs 38%; P < .001) and were less likely to have distal/tibial artery revascularization (Table I). Women who underwent open operations had a higher risk of surgical site infection (odds ratio [OR], 1.45; 95% confidence interval [CI], 1.3-1.6) and 30-day reintervention (OR, 1.2; 95% CI, 1.01-1.4) compared to men (Table II). Men with CLI who underwent endovascular intervention were more likely to undergo a major amputation within 30 days compared to women (OR, 1.3; 95% CI, 1.1-1.6). Overall, women had a higher risk of postoperative myocardial infarction (MI) and death compared to men (OR, 1.2; 95% CI, 1.02-1.4). Women undergoing LE revascularization for CLI are older, present with more advanced ischemia, and are more likely to undergo endovascular intervention compared to men. Despite increased use of less invasive strategies to treat CLI, women have higher rates of 30-day death and MI. Women with cardiovascular risk factors may benefit from more aggressive screening and medical treatment for PAD in order to mitigate the negative consequences of CLI.Table IBaseline patient and operative characteristicsFemale n = 8441Male n = 13,670P valueAge in years, mean (SD)70 (12)68 (11)<.001Race<.001 White4964 (59%)8944 (65%) Black or African American2078 (25%)2416 (18%) Other/unknown1399 (17%)2310 (17%)Diabetes4536 (54%)7619 (56%).004Hypertension7238 (86%)11,262 (82%)<.001Dialysis828 (10%)1450 (11%).06Smoking2635 (31%)5121 (38%)<.001Preoperative aspirin6804 (81%)10,974 (81%).55Preoperative statin5763 (69%)9684 (71%)<.001Preoperative beta-blocker5104 (61%)8369 (62%).23Preoperative function status<.001 Independent7122 (84%)12,196 (89%) Partially dependent1148 (14%)1256 (9%) Totally dependent118 (1%)134 (1%)Preoperative ABI <0.41698 (20%)2239 (16%)<.001Prior ipsilateral intervention3401 (40.3%)5146 (37.6%)<.001Open Intervention4717 (56%)8531 (62%)<.001 Operation type<.001Femoral popliteal bypass2623 (56%)3997 (47%)Femoral distal bypass1521 (32%)3152 (37%)Popliteal distal bypass435 (9%)1060 (13%)Femoral endarterectomy51 (1%)105 (1%) Conduit<.001Single segment vein2309 (49%)4411 (52%)Prosthetic/spliced vein2270 (48%)3798 (45%)Endovascular intervention3724 (44%)5139 (38%)<.001 Operation type<.001Femoral/popliteal angioplasty/stent2831 (77%)3362 (66%)Tibial angioplasty/stent867 (23%)1739 (34%)Operative time in minutes, mean (SD)186 (117)200 (121)<.001ABI, Ankle-brachial index; SD, standard deviation. Open table in a new tab Table IIThirty-day outcomesOpenEndovascularFemale n = 4717Male n = 8531P valueFemale n = 3724Male n = 5139P valueMyocardial infarction183 (3.9%)287 (3.3%)0.1284 (2.3%)92 (1.8%).12Surgical site infection496 (10.5%)639 (7.5%)<.00151 (1.4%)61 (1.2%).45Reintervention290 (6.1%)449 (5.3%)0.034152 (4.1%)258 (5.0%).038Major amputation209 (4.4%)375 (4.4%)0.93162 (4.4%)296 (5.8%).003Death77 (1.6%)119 (1.4%)0.2855 (1.5%)69 (1.3%).60 Open table in a new tab

Outcomes after Open Lower Extremity Revascularization in Patients with Critical Limb Ischemia

For decades, open intervention was the treatment of choice in patients requiring lower extremity revascularization. In the endovascular era, however, open and endovascular revascularization are options. The implications of prior revascularization on the outcomes for subsequent revascularization are not known. In the present study, we evaluated 30-day outcomes after open lower extremity revascularization for critical limb ischemia (CLI) in those who had previous interventions. The 2012-2017 open lower extremity bypass Participant User Data Files from the National Surgical Quality Improvement Program were used to identify a cohort of patients with CLI. Patients whose operation was considered emergent were excluded from the analysis. Patients were stratified on whether they had a previous open or endovascular intervention or undergoing a primary revascularization. The primary outcome measure was 30-day major adverse limb events (MALEs). Secondary outcomes included major adverse cardiac events (MACEs) and wound complications. A total of 12,668 patients met study criteria with 59.6% (n=7,549) undergoing a primary open revascularization, 22.4% (n=2,839) having a prior endovascular intervention, and 18.0% (n=2,280) having a prior open revascularization. There were notable differences in the baseline characteristics between the 3 groups. In addition, there were differences in the reason for intervention (rest pain versus tissue loss), type of revascularization, and type of conduit used between the 3 groups. After adjustment, a prior open revascularization was significantly associated with 30-day MALE when compared with a primary revascularization (adjusted odds ratio, 1.69; 95% confidence interval, 1.47-1.94; P<0.001) and prior endovascular intervention (adjusted odds ratio, 1.76; 95% confidence interval, 1.46-2.12; P<0.001). There were no differences in outcomes between primary revascularization and prior endovascular patients. There were no differences between MACEs or wound complications between the 3 groups. A prior endovascular intervention does not seem to accrue any additional short-term risk when compared with primary revascularization, suggesting an endovascular-first approach may be a safe strategy in patients with CLI. However, a prior open intervention is significantly associated with 30-day MALE in patients undergoing redo open revascularization, which may be related to the rapid decline in patients once they have exhausted their best open revascularization option.

Principles of angiology in lower extremity arterial disease (LEAD)

Lower extremity arterial disease (LEAD) is afrequent manifestation of atherosclerosis with ahigh risk for cardiovascular events. The measurement of the ankle-brachial index (ABI) should be used as ascreening method for LEAD. A differentiation is made between a stable stage of intermittent claudication and the stage of critical limb ischemia. The control of cardiovascular risk factors is crucial. Particular emphasis should be placed on smoking cessation and lipid-lowering treatment with statins and a target low-density lipoprotein (LDL)-cholesterol level of <55 mg/dl as a core element. In patients with symptomatic LEAD an inhibition of platelet aggregation is indicated. In addition to treatment with clopidogrel 75 mg or with acetylsalicylic acid (ASS) 100 mg in high risk patients the combination of ASS 100 mg and rivaroxaban 2 × 2.5 mg can be indicated. In critical limb ischemia revascularization (percutaneous intervention, operation) is always indicated to prevent amputation. First-line treatment in patients with intermittent claudication is exercise training. Revascularization can be indicated in patients with asevere limitation of walking distance.

4:03 PM Abstract No. 49 Outcomes of below-the-ankle revascularization and impact of pedal arch patency in critical limb ischemia

Report outcomes of below-the-ankle (BTA) revascularization in critical limb ischemia (CLI) and investigate the association of pedal arch patency with limb salvage. A single-center review was conducted of CLI patients undergoing BTA revascularization (2009-2018). Records were reviewed for demographics, comorbidities, technical details and wound healing. Postintervention arteriograms were classified as demonstrating a complete (CPA), incomplete (IPA) or absent (APA) pedal arch. Clinical endpoints included overall survival (OS), minor (ankle preserving) amputation-free survival (AFS) and major (above-the-ankle) AFS at 6- and 12-months following initial BTA intervention. Sixty consecutive Rutherford Class 5 and 6 patients underwent BTA revascularization with concurrent tibial (100%) and femoropopliteal (55%) endovascular therapy. The mean age was 69 years with 58% male, 82% diabetic, 56% CKD and 48% smoker. Angioplasty of 81 BTA lesions (53 dorsalis pedis, 16 pedal arch, 12 lateral plantar) was performed including adjunctive orbital atherectomy in 3 cases. The pedal loop technique was used in 6 cases and retrograde pedal access technique in 18 cases. The 6- and 12-month OS was 95% and 95% with 3 mortalities attributed to cardiac arrest on postop day 32, 44 and 59. The 6- and 12-month minor AFS rate was 63% and 63%, respectively, with average amputation at 0.9 months. The 6- and 12-month major AFS rate was 65% and 58%, respectively, with average amputation at 2.5 months. Mean follow-up was 18.3 months with 43% achieving complete wound healing on average at 7.4 months and 42% censored due to major amputation or death. Postintervention, there were 25 (42%) complete pedal arches (CPA) and 35 (58%) incomplete pedal arches. Subgroup analyses showed no significant difference (P > 0.05) between pedal arch status and demographics, comorbidities, OS, major AFS or wound healing rates. However, the association between CPA and minor AFS was significant (P < 0.001). This study establishes a CPA as predictive of avoiding minor amputation in patients with CLI. Further study to stratify angiographic endpoints and patient selection for BTA intervention is needed.

Malnutrition and Clopidogrel Non-Use Worsen Prognosis of Critical Limb Ischemia Patients After Revascularization.

Background: Critical limb ischemia (CLI) patients have high risk for major adverse cerebrovascular and cardiovascular events. This study investigated the risk factors of cerebrovascular or cardiovascular death in CLI patients with concomitant coronary artery disease (CAD).Methods and Results: The association between baseline characteristics and cerebrovascular or cardiovascular death ≤2 years after revascularization for CLI was investigated in 137 CLI patients who previously underwent successful revascularization for CAD before treatment for CLI. Twenty-three patients (17%) died. Geriatric nutritional risk index (GNRI) in the deceased group (DG) was significantly lower than in the surviving group (SG). On Cox proportional hazard multivariate analysis, hemodialysis (HD) and malnutrition (defined as GNRI <92) were significantly associated with cerebrovascular or cardiovascular death. Also, on Kaplan-Meier analysis, survival rate was significantly lower in CLI patients with either malnutrition or HD compared with patients without either malnutrition or HD, respectively. Furthermore, clopidogrel was less used in the DG than in the SG. The use of clopidogrel was associated with cerebrovascular or cardiovascular death. Especially, non-use of clopidogrel in the malnutrition group further increased the correlation with cerebrovascular or cardiovascular death.Conclusions: Malnutrition is a crucial risk factor for cerebrovascular and cardiovascular death in CLI patients with CAD. Nutritional status intervention and use of clopidogrel may be an important strategy for CLI.