Alik Farber

Early fasciotomy in patients with extremity vascular injury is associated with decreased risk of adverse limb outcomes: A review of the National Trauma Data Bank

INTRODUCTION AND OBJECTIVES Lower extremity (LE) arterial trauma and its treatment may lead to extremity compartment syndrome (ECS). In that setting, the decision to perform fasciotomies is multifactoral and is not well delineated. We evaluated the outcomes of patients with surgically treated LE arterial injury who underwent early or delayed fasciotomies. METHODS The National Trauma Data Bank (NTDB) was retrospectively reviewed for patients who had LE arterial trauma and underwent both open vascular repair and fasciotomies. Exclusion criteria were additional non-LE vascular trauma, head or spinal cord injuries, crush injuries, burn injuries, and declaration of death on arrival. Patients were divided into those who had fasciotomies performed within 8h (early group) or >8h after open vascular repair (late group). Comparative analyses of demographics, injury characteristics, complications, and outcomes were performed. RESULTS Of the 1469 patient admissions with lower extremity arterial trauma that met inclusion criteria there were 612 patients (41.7%) who underwent fasciotomies. There were 543 and 69 patients in the early and late fasciotomy groups, respectively. There was no significant difference in age, injury severity, mechanism of injury, associated injuries, and type of vascular repair between the groups. A higher rate of iliac artery injury was observed in the late fasciotomy group (23.2% vs. 5.9%, P<.001). Patients in the early fasciotomy group had lower amputation rate (8.5% vs. 24.6%, P<.001), lower infection rate (6.6% vs. 14.5%, P = .028) and shorter total hospital stay (18.5 ± 20.7 days vs. 24.2 ± 14.7 days, P = .007) than those in the late fasciotomy group. On multivariable analysis, early fasciotomy was associated with a 4-fold lower risk of amputation (Odds Ratio 0.26, 95% CI 0.14-0.50, P<.0001) and 23% shorter hospital LOS (Means Ratio 0.77, 95% CI 0.64-0.94, P = .01). CONCLUSION Early fasciotomy is associated with improved outcomes in patients with lower extremity vascular trauma treated with surgical intervention. Our findings suggest that appropriate implementation of early fasciotomy may reduce amputation rates in extremity arterial injury.

The BEST-CLI Trial: A Multidisciplinary Effort to Assess Which Therapy is Best for Patients With Critical Limb Ischemia

Critical limb ischemia (CLI) is the most severe form of peripheral arterial disease and is associated with a significant risk of limb loss. It is currently treated with limb revascularization by a variety of specialists. Although both open vascular bypass and endovascular therapy are offered to patients with infrainguinal peripheral arterial disease and CLI, significant disagreement exists as to which therapy works best in candidates for both types of intervention. Persistent clinical equipoise in combination with a paucity of comparative effectiveness data to guide treatment of CLI has led to a multidisciplinary effort to organize the Best Endovascular versus Best Surgical Therapy in patients with CLI (BEST-CLI) trial. The BEST-CLI trial is a pragmatic, multicenter, open label, randomized trial that compares best endovascular therapy with best open surgical treatment in patients eligible for both treatments. This trial is highly innovative in both its design and its collaborative nature. BEST-CLI aims to provide urgently needed clinical guidance for CLI management by using (1) a pragmatic design comparing the effectiveness of established techniques while allowing for the introduction of newer therapies as they become available; (2) a novel primary end point that includes limb amputation rates, repeat intervention, and mortality; (3) a multidisciplinary structure that fosters cooperation among interventional cardiologists, interventional radiologists, vascular surgeons, and vascular medicine specialists; and (4) novel techniques to evaluate the cost-effectiveness and quality-of-life outcomes of the 2 treatment strategies being tested.

Endovascular management of the popliteal artery: comparison of atherectomy and angioplasty.

Purpose: Symptomatic atherosclerotic disease of the popliteal artery presents challenges for endovascular therapy. We evaluated the technical success, complications, and midterm outcomes of atherectomy and angioplasty involving the popliteal segment. Methods: We conducted a retrospective review of outcomes of popliteal artery intervention using atherectomy or angioplasty performed between 2003 and 2008. Results: A total of 56 patients (36% women, age 72.8 ± 12.2 years, 77% critical limb ischemia) underwent popliteal atherectomy (n = 18) or angioplasty (n = 38). These patients had similar clinical characteristics, TransAtlantic Intersociety Consensus (TASC)/ TASC II classification, mean lesion length, and runoff scores. We observed a trend toward higher rates of technical success defined as <30% residual stenosis after atherectomy compared to angioplasty (94% vs 71%, P = .08). While angioplasty was associated with a higher frequency of arterial dissection (23% vs 0%, P = .003), atherectomy was associated with a higher rate of thromboembolic events (22% vs 0%, P = 0.01). Adjunctive stenting was used more frequently following angioplasty compared to atherectomy (45% vs 6%, P = .005). Thrombolysis was used to treat embolization in 4 patients in the atherectomy group. The improvement in the ankle-brachial index (ABI) was similar between the 2 treatment groups. Primary patency of the popliteal artery at 3, 6, and 12 months was 94%, 88%, and 75% in the atherectomy group and 89%, 82%, and 73% in the angioplasty group (P = not significant [NS]). There were no significant differences in limb salvage and freedom from reintervention at 1 year between the atherectomy and angioplasty groups. Conclusions: Our experience with popliteal artery endovascular therapy indicates a distinct pattern of procedural complications with atherectomy compared to angioplasty but similar midterm patency, limb salvage, and freedom from intervention.

Blood Transfusion for Lower Extremity Bypass Is Associated with Increased Wound Infection and Graft Thrombosis

BACKGROUND Packed RBC transfusion has been postulated to increase morbidity and mortality after cardiac/general surgical operations, but its effects after lower extremity bypass (LEB) have not been studied extensively. STUDY DESIGN Using the Vascular Study Group of New Englands database (2003-2010), we examined 1,880 consecutive infrainguinal LEB performed for critical limb ischemia. Perioperative transfusion was categorized as 0 U, 1 to 2 U, and ≥3 U. Cohort frequency group matching was used to compare groups of patients receiving 1 to 2 U and 0 U with patients receiving ≥3 U using age, coronary artery disease, diabetes, urgency, and indication of revascularization. Primary end points were perioperative mortality, wound infection, and loss of primary graft patency at discharge, as well as 1-year mortality and loss of primary graft patency. RESULTS In the study cohort, 1,532 LEBs (81.5%) received 0 U, 248 LEBs (13.2%) received 1 to 2 U, and 100 LEBs (5.3%) received ≥3 U transfusion. In the study cohort and group frequency matched cohort, transfusion was associated with significantly higher perioperative wound infection (0 U:4.8% vs 1 to 2 U: 6.5% vs ≥3 U: 14.0%; p = 0.0004) and graft thrombosis at discharge (4.5% vs 7.7% vs 15.3%; p < 0.0001). At 1 year, there were no differences in infection or graft patency. In multivariate analysis, transfusion was independently associated with increased perioperative wound infection in the study cohort and group frequency matched cohort (1 to 2 U vs 0 U: adjusted odds ratio [OR] = 1.4; 95% CI, 0.8-2.5; p = 0.263; ≥3 U vs 0 U: OR = 3.5; 95% CI, 1.8-6.7; p = 0.0002; overall p = 0.002) and increased graft thrombosis at discharge (1 to 2 U vs 0 U: OR = 2.1; 95% CI, 1.2-3.6; p = 0.01; ≥3 U vs 0 U: OR = 4.8; 95% CI, 2.5-9.2; p < 0.0001, overall p < 0.0001). CONCLUSIONS Perioperative transfusion in patients undergoing LEB is associated with increased perioperative wound infection and graft thrombosis. From this observational study, it appears transfusion does not have major consequences during mid-term follow-up, but the presumed benefits of blood replacement should be weighed carefully because of the increased risk of perioperative complications with transfusion.

The Role of Stent Grafts in the Management of Traumatic Tibial Artery Pseudoaneurysms: Case Report and Review of the Literature

Tibial artery pseudoaneurysms can occur in the setting of trauma. Operative exposure and repair of these injuries can be challenging, and surgical management options include direct arterial repair, interposition grafting, or arterial ligation. Other techniques including duplex-guided compression, thrombin injection, and endovascular intervention have been described. We present the case of a 39-year-old man who sustained blunt trauma to his right lower extremity and developed a delayed symptomatic pseudoaneurysm of the posterior tibial artery. He was successfully managed with endovascular stent graft exclusion of the pseudoaneurysm. Endovascular stent-grafting techniques can be successfully applied to the management of traumatic tibial pseudoaneurysms.

The Current State of Critical Limb Ischemia: A Systematic Review

Importance Chronic critical limb ischemia, marked by intractable lower extremity ischemic rest pain and tissue loss, is a highly morbid condition that leads to the loss of ambulation and decreased quality of life. It is associated with a high risk of limb loss and mortality and presents a significant economic burden to society. Objective To review the current state of epidemiology, pathophysiology, diagnosis, and treatment of critical limb ischemia. Evidence Review An extensive literature search of the subject matter was conducted on material published in English between 1980 and 2016; both landmark and recently published articles were evaluated. Articles were reviewed if they included the terms critical limb ischemia, ischemic rest pain, gangrene, or extremity ulcers. Findings Critical limb ischemia represents the end stage of peripheral arterial disease. Because peripheral arterial disease is most commonly caused by atherosclerosis, critical limb ischemia is heavily associated with smoking and diabetes. Revascularization is the cornerstone of therapy to prevent limb amputation, and both open vascular surgery and endovascular therapy play a key role in the treatment of patients with critical limb ischemia. However, few scientific data are available to identify the optimal revascularization strategy, which has led to a significant amount of variability and equipoise in the treatment of this condition. Medical therapy plays a significant role in optimizing coexistent cardiovascular risk factors and a limited role in improving limb outcomes in nonrevascularizable disease. Conclusions and Relevance Understanding critical limb ischemia and its treatment strategies is important for providing the best care for affected patients. Currently, ongoing randomized clinical trials in North America and the United Kingdom aim to provide data to support the best management of these patients.

Design and Rationale of the Best Endovascular Versus Best Surgical Therapy for Patients With Critical Limb Ischemia (BEST‐CLI) Trial

Background Critical limb ischemia (CLI) is increasing in prevalence, and remains a significant source of mortality and limb loss. The decision to recommend surgical or endovascular revascularization for patients who are candidates for both varies significantly among providers and is driven more by individual preference than scientific evidence. Methods and Results The Best Endovascular Versus Best Surgical Therapy for Patients With Critical Limb Ischemia (BEST‐CLI) Trial is a prospective, randomized, multidisciplinary, controlled, superiority trial designed to compare treatment efficacy, functional outcomes, quality of life, and cost in patients undergoing best endovascular or best open surgical revascularization. Approximately 140 clinical sites in the United States and Canada will enroll 2100 patients with CLI who are candidates for both treatment options. A pragmatic trial design requires consensus on patient eligibility by at least 2 investigators, but leaves the choice of specific procedural strategy within the assigned revascularization approach to the individual treating investigator. Patients with suitable single‐segment of saphenous vein available for potential bypass will be randomized within Cohort 1 (n=1620), while patients without will be randomized within Cohort 2 (n=480). The primary efficacy end point of the trial is Major Adverse Limb Event–Free Survival. Key secondary end points include Re‐intervention and Amputation‐Free‐Survival and Amputation Free‐Survival. Conclusions The BEST‐CLI trial is the first randomized controlled trial comparing endovascular therapy to open surgical bypass in patients with CLI to be carried out in North America. This landmark comparative effectiveness trial aims to provide Level I data to clarify the appropriate role for both treatment strategies and help define an evidence‐based standard of care for this challenging patient population. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02060630.

The BEST-CLI trial: a multidisciplinary effort to assess whether surgical or endovascular therapy is better for patients with critical limb ischemia

Critical limb ischemia (CLI) is the most severe form of peripheral arterial disease and is associated with a risk of limb loss. This vascular condition is currently treated with limb revascularization by surgery or endovascular intervention performed by a variety of specialists. Because both open vascular bypass and the less invasive endovascular therapy can be performed in selected patients with CLI, there exists significant disagreement as to which therapy should be performed first and which is more successful. The paucity of comparative effectiveness data to guide treatment of CLI has prompted a multidisciplinary effort to organize the Best Endovascular Versus Best Surgical Therapy in Patients With CLI (BEST-CLI) trial. The BEST-CLI trial is a pragmatic, multicenter, open-label, randomized trial that compares best endovascular therapy with best open surgical treatment in patients eligible for both treatments. BEST-CLI aims to provide urgently needed clinical guidance for CLI management by using a pragmatic design comparing the effectiveness of established techniques while allowing for the introduction of newer therapies as they become available; a novel primary endpoint that includes limb amputation rates, repeat intervention, and mortality; a multidisciplinary structure that fosters cooperation among interventional cardiologists, interventional radiologists, vascular surgeons, and vascular medicine specialists; and novel techniques to evaluate the cost-effectiveness and quality-of-life outcomes of the two treatment strategies being tested.

Optimal selection of patients for elective abdominal aortic aneurysm repair based on life expectancy

OBJECTIVE Elective abdominal aortic aneurysm (AAA) repair is beneficial when rupture is likely during a patients expected lifetime. The purpose of this study was to identify predictors of long-term mortality after elective AAA repair for moderately sized AAAs (<6.5-cm diameter) to identify patients unlikely to benefit from surgery. METHODS We analyzed 2367 elective infrarenal AAA (<6.5 cm) repairs across 21 centers in New England from 2003 to 2011. Our main outcome measure was 5-year life-table survival. Cox proportional hazards analysis was used to describe associations between patient characteristics and 5-year survival. RESULTS During the study period, 1653 endovascular AAA repairs and 714 open AAA repairs were performed. Overall, 5-year survival rates were similar by procedure type (75% endovascular repair, 80% open repair; P = .14). Advanced age ≥75 years (hazard ratio [HR], 2.0; P < .01) and age >80 years (HR, 2.6; P < .01), coronary artery disease (HR, 1.4; P < .04), unstable angina or recent myocardial infarction (HR, 4.6; P < .01), oxygen-dependent chronic obstructive pulmonary disease (HR, 2.7; P < .01), and estimated glomerular filtration rate <30 mL/min/1.73 m(2) (HR, 2.8; P < .01) were associated with poor survival. Aspirin (HR, 0.8; P < .03) and statin (HR, 0.7; P < .01) use were associated with improved survival. We used these risk factors to develop risk strata for low-risk, medium-risk, and high-risk groups with survival, respectively, of 85%, 69%, and 43% at 5 years (P < .001). CONCLUSIONS More than 75% of patients with moderately sized AAAs who underwent elective repair in our region survived 5 years, but 4% were at high risk for 5-year mortality. Patients with multiple risk factors, especially age >80 years, unstable angina, oxygen-dependent chronic obstructive pulmonary disease, and estimated glomerular filtration rate <30 mL/min/1.73 m(2), are unlikely to achieve sufficient long-term survival to benefit from surgery, unless their AAA rupture risk is very high.

Comparison of the efficacy of upper arm transposed arteriovenous fistulae and upper arm prosthetic grafts.

PURPOSE Direct comparison of transposed arteriovenous fistulas (tAVF) and arteriovenous grafts (AVG) has been hampered by inherent differences in patient characteristics between tAVF and AVG groups. In this study, using matching to control patient variables, we evaluated our outcomes with upper arm tAVF and upper arm prosthetic AVG. METHODS A retrospective review of all newly created upper arm tAVF and AVG was performed. One hundred ninety upper arm tAVF were group matched for age, gender, race, diabetes, and history of previous failed access with 168 AVG chosen from a pool of 476 concurrently performed AVG procedures. Complication, patency, and intervention rates were compared using multivariate analysis. RESULTS Mean follow up for our cohort was 29.1 months. Transposed fistulae consisted of 119 basilic vein and 71 cephalic vein transpositions, which were found to have similar demographic parameters, complication rates, and patency rates. There were no differences in 30 day mortality, 24 hour thrombosis, bleeding requiring exploration, or ischemic steal requiring intervention between the tAVF and AVG groups. More AVG developed infection requiring operative exploration than tAVF (7.9% vs 1.6%, respectively. P = .004). Primary patency for tAVF was higher than for AVG: 48% vs 14% at five years (P < .0001). Secondary patency rate for tAVF was also higher than for AVG: 57% vs 19% at five years (P < .0001). Nine percent of tAVF compared with 53% of AVG required one or more surgical and/or percutaneous revisions to maintain secondary patency (P < .0001). Multivariate analysis revealed that utilization of a tAVF was associated with a reduced risk of primary (Hazard Ratio [HR] 0.47, 95% Confidence Interval [CI] 0.35-0.64, P < .0001) and secondary failure (HR 0.59, 95% CI 0.42-0.81, P = .0001). CONCLUSIONS Transposed arteriovenous fistulas have significantly higher primary and secondary patency rates, require fewer revisions, and are less likely to develop a significant infection than AVG. This study supports the contention that as long as a patient is a candidate for a tAVF based on anatomic criteria, a tAVF should be considered before an AVG.