Morbidity and mortality of common femoral endarterectomy.

OBJECTIVE: Common femoral endarterectomy (CFE) comprises the current standard-of-care for symptomatic common femoral artery occlusive disease. Although it provides effective inflow revascularization via a single incision, it remains an invasive procedure in an often-frail patient population. The purpose of this retrospective clinical study was to assess the morbidity and mortality of CFE in a contemporary cohort. METHODS: Consecutive CFEs performed at a large, urban hospital were reviewed. Six-month mortality, local complications (hematoma, lymphatic leak, pseudoaneurysm, wound infection, and/or dehiscence), and systemic complications were analyzed using univariate and multivariate analyses. RESULTS: A total of 129 isolated CFEs were performed over 7 years for claudication (36%), rest pain (16%), tissue loss (29%), or acute on chronic limb ischemia (21%). Mean age was 75 ± 9 years, and 68% of patients were male. Comorbidities were prevalent, including coronary artery disease (54%), diabetes (41%), chronic pulmonary disease (25%), and congestive heart failure (22%). The majority of CFEs were performed under general anesthesia (98%) with patch angioplasty using bovine pericardium (73% vs 27% Dacron). Twenty-two patients (17%) sustained local complications following the procedure; their occurrence was significantly associated with obesity (P = .002) but no technical or operative factors. Nineteen patients (15%) sustained serious systemic complications; their occurrence was significantly associated with chronic limb-threatening ischemia (P < .001), and a high American Society of Anesthesiologists (ASA) class (P = .002). By 6 months, 17 patients (13%) had died. Being on dialysis, presenting with chronic limb-threatening ischemia, and being in a high ASA class at the time of operation were all associated with 6-month mortality; a high ASA class at the time of operation was independently predictive of mortality (odds ratio, 3.08; 95% confidence interval, 1.03-9.24; P = .044). CONCLUSIONS: Although commonly performed, CFE is not a benign vascular procedure. Disease presentation, anesthetic risk, and expected longevity play an important role in clinical outcomes. Evolving endovascular approaches to the common femoral artery could serve to reduce morbidity and mortality in the future.

Comparative Analysis of Outcomes in Patients Undergoing Femoral Endarterectomy plus Endovascular (Hybrid) or Bypass for Femoropopliteal Occlusive Disease.

INTRODUCTION: The gold-standard for management of combined common femoral artery (CFA) and superficial femoral artery (SFA) atherosclerotic occlusive disease has traditionally been open femoral endarterectomy and femoral-popliteal bypass. Hybrid approaches involving an open and endovascular component are increasingly common. The aim of this study was to compare perioperative outcomes in patients who underwent an open versus hybrid revascularization. METHODS: NSQIP data, years 2012-2017, were queried for patients who underwent nonemergent CFA endarterectomy with either SFA transluminal intervention or bypass. The primary outcome of interest was a composite of cardiovascular, pulmonary, and renal complications (systemic) and mortality. Two propensity-weight adjusted analyses were performed: 1) comparing hybrid and prosthetic bypass 2) comparing hybrid and vein bypass. RESULTS: There were 4,478 patients included (1,537 hybrid, 1,408 prosthetic, 1,533 vein); 64.8% were men, and the mean age was 67.8 ± 9.7 years; 29.9% had claudication, 38.8% had tissue loss, and 31.3 were unspecified. In the propensity-weighted analysis comparing hybrid to prosthetic bypass, there was no difference in systemic complications (OR = 1.29 for prosthetic vs. hybrid; 95% CI: 0.95-1.76; P = 0.107) or mortality (OR = 1.54; 95% CI: 0.71-3.33; P = 0.275). Prosthetic bypass was associated with more deep surgical-site infections (OR = 2.02; 95% CI: 1.19-3.45; P = 0.010), postoperative sepsis (OR = 2.07; 95% CI: 1.13-3.76; P = 0.018), unplanned 30-day readmission (OR = 1.28; 95% CI: 1.04-1.58; P = 0.021), and the composite of any complication (OR = 1.38; 95% CI: 1.18-1.61; P < 0.001). In the propensity-weighted analysis comparing hybrid to vein bypass, there was no difference in systemic complications (OR = 1.10 for vein vs. hybrid; 95% CI: 0.81-1.49; P = 0.552) or mortality (OR = 0.91; 95% CI: 0.42-2.00; P = 0.819). Vein bypass was associated with more superficial surgical-site infections (OR = 1.45; 95% CI: 1.04-2.02; P = 0.028), and the composite of any complication (OR = 1.32; 95% CI: 1.13-1.54; P = 0.001). Overall mortality was significantly higher patients with systemic complications (13.9% vs 0.1%; P < 0.001). Systemic complications were less common in patients with claudication undergoing hybrid revascularization than vein or prosthetic bypass. CONCLUSIONS: Claudicants undergoing bypass experienced more systemic complications than those undergoing hybrid procedures, but there appears to be no increased risk of systemic complications or mortality with open reconstruction when compared to hybrid procedures for other indications. Other complications, such as infection, postoperative transfusion, and readmission, were more common in the bypass groups.

Eversion Endarterectomy of the External Iliac Artery in Treating Chronic Limb-Threatening Ischemia in TASC II C and D Iliofemoral Occlusive Disease.

BACKGROUND: Endovascular treatment of iliofemoral occlusive disease is a challenging approach, especially for TransAtlantic Inter-Society C and D lesions. Therefore, the revascularization procedure in such situations is preferably performed by bypass graft surgery with synthetic materials. The purpose of this study is to report the feasibility and mid-term results of eversion endarterectomy of the external iliac artery (EEEIA), as an alternative autologous option. METHODS: Retrospective study with 18 EEEIA performed between September 2015 and February 2020, exclusively for chronic limb-threatening ischemia treatment in patients with increased risk of postoperative surgical infection and inadvisable for endovascular treatment. Demographic, clinical variables and outcomes were collected from a prospective database. The main end points are: amputation-free survival (AFS) and 30-day mortality. Secondary end points include: primary patency (PP), cumulative patency (CP), overall survival (OS), and postoperative surgical complication. Kaplan-Meier analysis was used to estimate cumulative time of outcomes. RESULTS: The mean age was 64.8 ± 8.3 years, with predominance of men. The median follow-up period was 1012 days, 95% confidence interval [119, 1365] days. Most had Rutherford 5 (n = 13, 72.2%) and mean ankle brachial index was 0.38 ± 0.22. The PP, CP, AFS, and OS in 730 days were 81%, 92%, 80%, and 88%, respectively. There was no 30-day mortality or postoperative surgical infection. CONCLUSIONS: Iliofemoral reconstruction through EEEIA is an effective surgical procedure with good patency rates, AFS and OS. In addition, it can be considered an useful and safe option, especially in cases in which a prosthesis should be avoided.

Outcomes of Pulmonary Endarterectomy Operation Concomitant with Cardiac Procedures.

BACKGROUND: The aim of this study was to analyze the results of pulmonary endarterectomy (PEA) performed simultaneously with additional cardiac procedures in a single tertiary-level center. METHODS: Data of patients who underwent PEA with additional cardiac procedures for chronic thromboembolic pulmonary hypertension (CTEPH) in our clinic were retrospectively reviewed using patient records. RESULTS: Between March 2011 and April 2019, 56 patients underwent PEA with additional cardiac surgery. The most common additional procedure was coronary artery bypass grafting (21 patients; 38%). The median intensive care unit and hospital stays were 4 (3-6) days and 10 (8-14) days. Mortality was recorded in six patients (11%). In multivariate analysis, only preoperative pulmonary vascular resistance (PVR) (p = 0.02; odds ratio [OR]: 1.003) and cardiopulmonary bypass duration (p = 0.02; OR: 1.028) were associated with mortality. When the cutoff value of 1000 dyn.s.cm-5 was taken in the receiver operating characteristic curve analysis, preoperative PVR predicted mortality with 83% sensitivity and 94% specificity (area under curve = 0.89; p < 0.01). CONCLUSION: PEA for CTEPH may be performed safely with other cardiac operations. This type of surgery is a complex procedure that should be performed only in expert centers. Patients with high preoperative PVR are at increased risk of perioperative complications.

An Evaluation of the Learning Curve in Pulmonary Endarterectomy Using Propensity Score Matching.

OBJECTIVE: Pulmonary endarterectomy (PEA) is the only causative, but demanding treatment of choice for chronic thromboembolic pulmonary hypertension (CTEPH). We analyzed our results with PEA to evaluate the learning curve. METHODS: Consecutive 499 patients who underwent PEA between 1995 and 2014 were divided into two groups according to the temporal order: early cohort (n = 200, December 1995-March 2006), and late cohort (n = 299, March 2006-December 2014). We assessed perioperative outcomes after PEA as compared between the early and the late cohort also in propensity-score-matched cohorts. RESULTS: Age at the surgery was older in the late cohort (p = 0.042). Preoperative mean pulmonary artery pressure (mPAP) was 46.8 ± 11.0 mm Hg in the early cohort and 43.5 ± 112.7 mm Hg in the late cohort (p = 0.0035). The in-hospital mortality in the early and late cohorts was 14.0% (28/200) and 4.7% (14/299), respectively (p = 0.00030). The duration of circulatory arrest (CA) became much shorter in the late cohort (42.0 ± 20.5 min in the early and 24.2 ± 11.6 min in the late cohort, respectively, p < .0001). In matched cohorts, the in-hospital mortality showed no significant difference (8.7% in the early cohort and 5.2% in the late cohort, < 0.0001). The CA duration, however, was still shorter in the late cohort (p <0.0001). CONCLUSIONS: Over time, older patients have been accepted for surgery, more patients were operated for lesser severity of CTEPH. Duration of CA and mortality decreased even beyond the first 200 patients, indicating a long learning curve.

The Reintervention Index: A New Outcome Measure for Comparative Effectiveness of Lower Extremity Revascularization.

BACKGROUND: Reinterventions after lower extremity revascularization (LER) are common. Current outcome measures assessing durability of revascularization rely on freedom from reintervention but do not account for the frequency of repeated LER. The aim of this study is to compare the reintervention index, defined as the mean number of repeat LER, after open and endovascular revascularization. We hypothesized that endovascular procedures have reduced durability and increased frequency of reinterventions. METHODS: A retrospective review of the charts of consecutive patients undergoing LER for peripheral artery disease (PAD) in 2013-2014 by multiple specialties in a tertiary care center was performed. Patients were divided into open and endovascular groups based on the first LER procedure performed during the study period. Patient characteristics and outcomes were compared between the 2 groups. Multivariable regression was performed to determine factors associated with reintervention. RESULTS: There were 367 patients (Endo = 316, Open = 51). A total of 211 patients underwent 497 reinterventions (reintervention rate = 57.5%, reintervention index = 2.35 ± 2.02 procedures [range 1-11]). Patients in the open group were more likely to be smokers (P = 0.018) and to have prior open LER (P = 0.003), while patients in the endovascular group were older (P < 0.001) and more likely to have cardiovascular comorbidities. On follow-up, there was no difference in overall or ipsilateral reintervention rates or reintervention indices between endovascular and open LER. Major amputation was significantly higher after open LER (19.61% vs. 8.54%, P = 0.013) but there was no difference in survival (P = 0.448). Multivariable analysis did not show a significant relationship between type of procedure and reintervention. CONCLUSIONS: The reintervention index provides a measure to assess the frequency of repeat LER. Patients with PAD, in this study, are afflicted with similar extent of reinterventions after open and endovascular LER.

Treatment of Lymphatic Complications after Common Femoral Artery Endarterectomy.

BACKGROUND: This study analyzes the outcome of lymphatic complications after a standard vascular procedure. METHODS: This is a retrospective study including patients who had a lymphatic complication after endarterectomy and patch of the common femoral artery in our clinic between March 2007 and June 2018. Therapy of choice was selected according to wound situation and amount of lymphatic liquid. If signs of a wound infection occurred, a surgical therapy was performed; in all other cases a nonsurgical treatment (conservative treatment, radiotherapy) was chosen. RESULTS: We performed 977 index operations, a lymphatic complication occurred in 112 cases (11.5%). In 69 cases the lymphatic complication presented as lymphatic fistula (Group 1), in 43 cases as lymphorrhea from the wound (Group 2). Nonsurgical treatment was done in 66 cases (Group 1: 76.8% vs. Group 2: 30.2%; P < 0.000), and a surgical treatment was necessary in 46 cases (Group 1: 23.2% vs. Group 2: 69.8%; P < 0.000). Indication for surgery was Szilagyi 1 infection in 25 cases, Szilagyi 2 infection in 11 cases, and Szilagyi 3 infection in 10 cases. Patients with Szilagyi 1 infections received negative wound pressure therapy (NWPT). A muscle flap in combination with an NWPT was performed in patients with Szilagyi 2 infections. In Szilagyi 3 infections, the patch was replaced; additionally, a muscle flap and an NWPT were performed. The median hospital stay was 13 days in the nonsurgical group and 22.5 days in the surgical group. We had no bleeding complications and no reinfection during follow-up. The median observation period was 23.0 months. Age ≥80 years was associated with an increased risk for lymphatic complications. CONCLUSIONS: The therapy of lymphatic complications should be done in accordance with clinical symptoms. A nonsurgical treatment is often sufficient. However, in cases of a wound infection different surgical treatments are necessary.

Angiotensin Converting Enzyme Inhibitors and Angiotensin II Receptor Blockers (ACEI/ARB) are Associated with Improved Limb Salvage after Infrapopliteal Interventions for Critical Limb Ischemia.

BACKGROUND: Angiotensin-converting enzyme Inhibitors and Angiotensin II Receptor Blockers (ACEI/ARB) reduce the risk of cardiovascular events and mortality in patients with peripheral arterial disease (PAD). However, their effect on limb-specific outcomes is unclear. The objective of this study is to assess the effect of ACEI/ARB on patency and limb salvage in patients undergoing interventions for critical limb ischemia (CLI). METHODS: Patients undergoing infrainguinal revascularization for CLI (Rutherford 4-6) between 06/2001 and 12/2014 were retrospectively identified. Primary Patency (PP), Secondary Patency (SP), Limb Salvage (LS), major adverse cardiac events (MACE), and survival rates were calculated using Kaplan-Meier. Multivariate analysis was performed using Cox regression. RESULTS: A total of 755 limbs in 611 patients (311 ACEI/ARB, 300 No ACEI/ARB) were identified. Hypertension (86% vs. 70%, P < 0.001), diabetes (68% vs. 55%, P = 0.001) and statin use (61% vs. 45%, P < 0.001) were significantly greater in the ACEI/ARB group. Interventions were performed mostly for tissue loss (83% ACEI/ARB vs. 84% No ACEI/ARB, P = 0.73). Comparing ACEI/ARB versus No ACEI/ARB, in femoropopliteal interventions, 60-month PP (54% vs. 55%, P = 0.47), SP (76% vs. 75%, P = 0.83) and LS (84% vs. 87%, P = 0.36) were not significantly different. In infrapopliteal interventions, 60-month PP (45% vs. 46%, P = 0.66) and SP (62% vs. 75%, P = 0.96) were not significantly different. LS was significantly greater in ACEI/ARB (75%), as compared to No ACEI/ARB (61%) (P = 0.005). Cox regression identified diabetes (HR 2.4 (1.4-4.1), P = 0.002), ESRD (HR 3.5 (2.1-5.7), P < 0.001), hypertension (HR 0.4 (0.2-0.6), P < 0.001), and ACEI/ARB (HR 0.6 (0.4-0.9), P = 0.03), as factors independently associated with LS after infrapopliteal interventions. Freedom from MACE (ACEI/ARB 37% vs. 32%, P = 0.82) and overall survival (ACEI/ARB 42% vs. 35% No ACEI/ARB, P = 0.84) were not significantly different. CONCLUSIONS: ACEI/ARB is associated with improved limb salvage in CLI patients undergoing infrapopliteal interventions, but not after femoropopliteal interventions. ACEI/ARB had no impact on patency rates. They were also associated with a trend toward improved survival and freedom from MACE. Our findings suggest that the use of ACEI/ARB may improve outcomes in the high-risk CLI patient population.

A single-center experience in the eversion femoral endarterectomy.

OBJECTIVES: Endarterectomy is the treatment of choice for arterial occlusive disease of the femoral bifurcation. Longitudinal arteriotomy and prosthetic patch angioplasty is the standard technique but, due to the increasing concerns with prosthetic-related infections and multidrug-resistant pathogens our group adopted an alternative approach. We present our experience with eversion femoral endarterectomy. METHODS: All patients submitted to eversion femoral endarterectomy in a single institution during 2016-2019 were retrospectively analyzed. Patient demographics, surgical data, and complications were captured from medical records. RESULTS: Nineteen patients, 84.2% male and a median age of 67 years (IQR 62-78) were submitted to eversion femoral endarterectomy with a median follow-up of 180 days (IQR 71-395). Seventeen (89.4%) patients were treated for chronic limb ischemia and the other two were submitted to femoral endarterectomy during endovascular aortic aneurysm repair. Most of the patients had smoking history (84.2%), followed by hypertension (68.4%), dyslipidemia (63.2%), coronary heart disease (29.4%), and diabetes (26.3%). Only 3 patients (15.8%) were submitted exclusively to endarterectomy, 13 (68.4%) were submitted to endarterectomy as an adjuvant for peripheral endovascular treatment, 2 (10.5%) as a concomitant procedure to endovascular repair of aortic aneurysm, and 1 (5.3%) was complemented with thrombectomy of the femoro-popliteal sector. Primary patency rates were 100% and 87.5% (CI (38.7-98.1)) at 6 and 12 months, respectively. Primary-assisted and secondary patency rates were 100%. The 30-day mortality rate was 5.3% (n = 1) and complication rate 10.5% (n = 2). One patient complicated with acute renal disease related to rhabdomyolysis. Another patient developed a wound-related hematoma treated with surgical drainage, but died three days after consequent to ischemia-reperfusion injury. CONCLUSIONS: Eversion femoral endarterectomy is a safe and feasible technique, with good patency results and respecting the concept of leaving nothing behind. A careful control of the proximal and distal endpoints is essential for the success of the technique.

Improving 1-Year Outcomes of Infrainguinal Limb Revascularization: Population-Based Cohort Study of 104 000 Patients in England.

BACKGROUND: The availability and diversity of lower limb revascularization procedures have increased in England in the past decade. We investigated whether these developments in care have translated to improvements in patient pathways and outcomes. METHODS: Individual-patient records from Hospital Episode Statistics were used to identify 103 934 patients who underwent endovascular (angioplasty) or surgical (endarterectomy, profundaplasty, or bypass) lower limb revascularization for infrainguinal peripheral artery disease in England between January 2006 and December 2015. Major lower limb amputations and deaths within 1 year after revascularization were ascertained from Hospital Episode Statistics and Office for National Statistics mortality records. Competing risks regression was used to estimate the cumulative incidence of major amputation and death, adjusted for patient age, sex, comorbidity score, indication for the intervention (intermittent claudication, severe limb ischemia without record of tissue loss, severe limb ischemia with a record of ulceration, severe limb ischemia with a record of gangrene/osteomyelitis), and comorbid diabetes mellitus. RESULTS: The estimated 1-year risk of major amputation decreased from 5.7% (in 2006-2007) to 3.9% (in 2014-2015) following endovascular revascularization, and from 11.2% (2006-2007) to 6.6% (2014-2015) following surgical procedures. The risk of death after both types of revascularization also decreased. These trends were observed for all indication categories, with the largest reductions found in patients with severe limb ischemia with ulceration or gangrene. Overall, morbidity increased over the study period, and a larger proportion of patients was treated for the severe end of the peripheral artery disease spectrum using less invasive procedures. CONCLUSIONS: Our findings show that from 2006 to 2015, the overall survival increased and the risk of major lower limb amputation decreased following revascularization. These observations suggest that patient outcomes after lower limb revascularization have improved during a period of centralization and specialization of vascular services in the United Kingdom.

Remote iliac artery endarterectomy with selective stent use at the proximal dissection zone in TransAtlantic Inter-Society Consensus C and D lesions.

BACKGROUND: Remote iliac artery endarterectomy (RIAE) is a challenging technique in the treatment of arterial occlusive disease. The impact of proximal transection zone stenting on patency rates is still unclear. METHODS: This is a retrospective analysis of all patients who underwent RIAE in our hospital between March 2007 and October 2017. A stent was used in cases with a dissection flap or a stenosis at the proximal transection zone after RIAE. In all other cases, we did not use a stent. Study end points were patency rates, limb salvage, and survival after 5 years. RESULTS: There were 115 RIAEs performed in 108 patients. All lesions were TransAtlantic Inter-Society Consensus C (61.7%) or D (38.3%) lesions. The median follow-up time was 38.5 months (range, 0-117 months). The indications were claudication in 67.0% and critical limb ischemia in 33.0%. Group 1 (n = 56) included all patients without a stent; group 2 (n = 59) included all patients with stenting of the proximal dissection zone. Risk factors were similar between the groups. The 30-day morbidity and mortality rates between the groups were not significantly different. The primary patency rate was 81.6% (group 1, 76.2%; group 2, 87.6%; P = .286), the primary assisted patency rate was 91.9% (group 1, 94.0%; group 2, 90.0%; P = .512), and the secondary patency rate was 93.8% (group 1, 94.0%; group 2, 91.6%; P = .435) after 5 years. Limb salvage (97.2%; group 1, 100%; group 2, 94.5%; P = .084) and survival time (57.1%; group 1, 66.7%; group 2, 43.5%; P = .170) were also not significantly different between the groups. A restenosis at the transection zone occurred in 14.3% in group 1 and 1.7% in group 2 (P = .013) during follow-up. A newly formed occlusion of the hypogastric artery was seen in 5.2% of patients after RIAE. CONCLUSIONS: RIAE is a safe procedure with excellent patency rates. However, the restenosis rate is higher in cases without stenting.

Systematic review of endovascular intervention and surgery for common femoral artery atherosclerotic disease.

BACKGROUND: Endovascular intervention has emerged as a potential alternative to open surgery in treating common femoral artery (CFA) atherosclerotic disease. The aim of this systematic review was to assess the safety and efficacy of both techniques. METHODS: Thirteen electronic databases from 1980 to 3 January 2018 were searched. Study quality was assessed using the National Institute for Health and Care Excellence Interventional Procedure Programme quality assessment tool. Safety and efficacy outcome measures were analysed. RESULTS: Thirty-one studies reporting 813 endovascular procedures and 3835 endarterectomies were included. Only two small RCTs have been reported. The methodological quality of available studies was generally low and follow-up short. Safety endpoint assessment revealed a similar risk of wound haematoma for endovascular intervention and endarterectomy (5·5 (95 per cent c.i. 0·2 to 17·2) versus 3·9 (1·7 to 6·9) per cent respectively), a lower risk of wound infection with endovascular procedures (0 versus 5·9 (3·4 to 9·0) per cent) and a lower risk of wound lymph leakage (0 versus 5·7 (3·3 to 8·6) per cent). Efficacy endpoint assessment at 1 year identified that endovascular intervention had a lower primary patency rate than endarterectomy (78·8 (73·3 to 83·8) versus 96·0 (92·2 to 98·6) per cent respectively), a higher revascularization rate (16·0 (6·1 to 29·4) versus 5·8 (1·0 to 14·2) per cent) and a similar amputation rate (2·7 (1·2 to 4·8) versus 1·9 (0·7 to 3·8) per cent). CONCLUSION: Endovascular intervention of CFA disease appears to reduce the risk of wound complications but is associated with a lower patency rate and increased rates of subsequent revascularization procedures. Standardization of the endovascular technique and quantification of the proportions of patients suitable for either technique are required.

Infection of Prosthetic Patches after Femoral Endarterectomy: An Unreported Complication.

BACKGROUND: The femoral prosthetic patch is a surgical procedure frequently used to treat atherosclerotic lesions involving femoral artery bifurcation. Even though it is an easy to perform procedure, surgical management of complications, first of all graft infection, may be challenging, with a high morbidity and mortality risk for patients. We report our experience on surgical treatment of femoral patch infections. MATERIALS AND METHODS: Between April 2012 and April 2018, 26 patients (26 limbs) were referred to the emergency department at our institution for the treatment of femoral prosthetic patch infections. None of the patients had been previously treated at our institution. All patients underwent a wide debridement of the infection site. Blood flow was restored through a vein interposition graft anastomosed at least 4-5 cm from the site of infection. End points of the study were death-related events, major or minor limb loss (major loss for above or below the knee amputation and minor for foot or toe), vein interposition graft failures, recurrent graft infections, or surgical wound healing. RESULTS: A total of 26 patients (21 male and 5 female patients) underwent surgical treatment. The mean age of patients was 69 years. The majority of our patients (54%) had been previously treated with an isolated femoral artery prosthetic patch. Three (11%) patients had been treated with a bilateral prosthetic femoral patch, but only one side was infected. After debridement of the infection site, we used the great saphenous vein to revascularize the lower limb in 22 (85%) cases, whereas the cephalic vein was used in only 4 cases (15%). The 5-year survival rate was 81% (standard error [SE] = 0.12). The 5-year primary patency rate was 70% (SE = 0.14). During follow-up, 4 graft occlusions occurred, and in 2 cases, a major amputation was required. The limb salvage rate at 5 years was 81% (SE = 0.13). CONCLUSIONS: An infection can complicate the femoral prosthetic patch carrying a high rate of morbidity, mortality, and limb loss. Surgical indication for a primary procedure must be restricted to critical limb ischemia, and it must be associated to a multilevel correction of the atherosclerotic disease.

Atherosclerotic plaque characteristics are not associated with future cardiovascular events in patients undergoing iliofemoral endarterectomy.

BACKGROUND: Plaque characteristics such as intraplaque hemorrhage (IPH) have been associated with secondary cardiovascular events (CVE) in patients undergoing carotid endarterectomy. In addition, carotid plaques containing macrophage infiltration or a large lipid core size were associated with less restenosis. It is currently unknown whether iliofemoral plaque histopathologic characteristics are predictive for secondary CVE in patients with peripheral arterial disease undergoing iliofemoral endarterectomy. The aim of this study was to examine the association between iliofemoral atherosclerotic plaque characteristics and secondary CVE in patients undergoing iliofemoral endarterectomy. METHODS: There were 497 patients with iliofemoral atherosclerotic disease who underwent primary endarterectomy of the iliac or femoral artery from 2002 to 2013 included. All specimen were uptaken in the Athero Express biobank and 7 histologic plaque characteristics were analyzed: calcification, collagen, fat content, IPH, macrophages, smooth muscle cells, and vessel density. The composite CVE consisted of myocardial infarction, cerebrovascular accident, peripheral (re-)interventions, and cardiovascular death. Multivariate Cox regression models were used to examine the association between plaque and the composite end point during a follow-up period of 3 years. RESULTS: Of the 497 patients, 225 (46.4%) experienced a composite CVE within 3 years after the initial surgery. Calcified plaques were univariably associated with composite CVE (hazard ratio [HR], 1.32; 95% confidence interval [CI], 1.00-1.73; P = .049). After correction for confounders, multivariable analyses showed no association between calcified plaques and composite CVE (HR, 1.13; 95% CI, 0.85-1.50; P = .413). IPH was not predictive of secondary CVE (HR, 1.02; 95% CI, 0.79-1.33; P = .867). CONCLUSIONS: In this cohort of patients with peripheral arterial disease undergoing iliofemoral endarterectomy, investigated atherosclerotic plaque characteristics were not independently associated with secondary CVE during follow-up.

Eversion endarterectomy of the deceased donor renal artery to prevent kidney discard.

INTRODUCTION: Deceased donor (DD) kidneys exhibiting severe atherosclerosis involving the renal artery (RA) may represent a contraindication to kidney transplantation (KT). METHODS: Eversion endarterectomy (EE) was performed as a salvage procedure to permit KT. RESULTS: We identified 17 cases (1.2% of all DD KTs during the study period) involving EE of the DD RA. Thirteen (76.5%) kidneys were imported, and mean Kidney Donor Profile Index (KDPI) was 81%. Mean DD age was 59 years, mean RA plaque length was 1.7 cm, and mean glomerulosclerosis on biopsy was 10%. Mean recipient age was 64 years, and dialysis vintage was 32 months. With a mean follow-up of 36 months, actual patient and graft survival rates were both 76.5%. One patient died early without a technical problem. Of the remaining 16 patients, 2-year patient and graft survival rates were both 100%. There were no early or late vascular complications. The incidence of delayed graft function was 35%. Mean serum creatinine and GFR levels in patients with functioning grafts at latest follow-up were 1.8 mg/dL and 40 mL/min, respectively. CONCLUSIONS: EE appears to be a safe and under-utilized procedure that may prevent discard of marginal donor kidneys and is associated with acceptable short-term outcomes.

Hybrid Revascularization Combining Iliofemoral Endarterectomy and Iliac Stent Grafting for TransAtlantic Inter-Society Consensus C and D Aortoiliac Occlusive Disease.

BACKGROUND: This study examines the outcome of hybrid revascularization combining iliofemoral endarterectomy and iliac artery stenting using covered stents in TransAtlantic Inter-Society Consensus (TASC) C and D aortoiliac occlusive disease (AIOD) involving the common femoral artery (CFA). METHODS: A retrospective review was conducted in patients with TASC C and D AIOD involving the CFA and undergoing hybrid revascularization. Covered stents were used primarily. Demographics, indications for surgery, lesion classification, hospital length of stay (LOS), 30-day morbidity/mortality, hemodynamic and clinical success, and patency were assessed. RESULTS: Thirty-six male patients (41 limbs), mean age 63.9 ± 6 years, were identified (TASC C = 39%, D = 61%). Indications for surgery were claudication (27%), rest pain (44%), and tissue loss (29%). A simultaneous adjunctive procedure (5 infrainguinal bypass, 3 superficial femoral artery stents) was performed in 22%. Thirty-day outcomes included 1 mortality (2.7%) and 2 reoperation (5.5%), 1 for femoral artery pseudoaneurysm and 1 for bilateral groin seroma. LOS was 4 days (interquartile range 3-6). All patients with available data experienced 30-day clinical and hemodynamic success. Mean follow-up was 23 months (range 1-79 months) with a primary patency of 85.4%. Cumulative primary assisted and secondary patency was 92.6%. The femoral patch repair was the most frequent site of reintervention (3/3). Mortality was 34% during the study period, and it was significantly higher in patients with tissue loss (57.1% vs. 14.8%, P = 0.01). CONCLUSIONS: The hybrid approach has low morbidity, mortality, and fast recovery. The use of covered stents/stent grafts provides good mid-term patency. Close follow-up with noninvasive imaging is paramount to avoid repair failure, in particular at the femoral patch repair site.

Rationale and methods of the IDOMENEO health outcomes of the peripheral arterial disease revascularisation study in the GermanVasc registry.

BACKGROUND: Atherosclerotic disease of the lower extremity arteries (PAD) remains a significant burden on global healthcare systems with increasing prevalence. Various guidelines on the diagnosis and treatment of patients with PAD are available but they often lack a sufficient evidence base for high-grade recommendations since randomized and controlled trials (RCT) remain rare or are frequently subject to conflicts of interest. This registry trial aims to evaluate the outcomes of catheter-based endovascular revascularisations vs. open-surgical endarterectomy vs. bypass surgery for symptomatic PAD on medical and patient-reported outcomes. METHODS AND DESIGN: The study is a prospective non-randomized multicentre registry trial including invasive revascularisations performed in 10 000 patients treated for symptomatic PAD at 30 to 40 German vascular centres. All patients matching the inclusion criteria are consecutively included for a recruitment period of six months (between May and December 2018) or until 10 000 patients have been included in the study registry. There are three follow-up measures at three, six, and 12 months. Automated completeness and plausibility checks as well as independent site visit monitoring will be performed to assure high internal and external validity of the study data. Study endpoints include relevant major cardiovascular and limb events and patient-reported outcomes from two Delphi studies with experts in vascular medicine and registry-based research. DISCUSSION: It remains unclear if results from RCT can reflect daily treatment practice. Furthermore, great costs and complexity make it challenging to accomplish high quality randomized trials in PAD treatment. Prospective registry-based studies to collect real-world evidence can help to overcome these limitations.

Dynamic Risk Stratification of Patient Long-Term Outcome After Pulmonary Endarterectomy: Results From the United Kingdom National Cohort.

BACKGROUND: Chronic thromboembolic pulmonary hypertension results from incomplete resolution of pulmonary emboli. Pulmonary endarterectomy (PEA) is potentially curative, but residual pulmonary hypertension following surgery is common and its impact on long-term outcome is poorly understood. We wanted to identify factors correlated with poor long-term outcome after surgery and specifically define clinically relevant residual pulmonary hypertension post-PEA. METHODS AND RESULTS: Eight hundred eighty consecutive patients (mean age, 57 years) underwent PEA for chronic thromboembolic pulmonary hypertension. Patients routinely underwent detailed reassessment with right heart catheterization and noninvasive testing at 3 to 6 months and annually thereafter with discharge if they were clinically stable at 3 to 5 years and did not require pulmonary vasodilator therapy. Cox regressions were used for survival (time-to-event) analyses. Overall survival was 86%, 84%, 79%, and 72% at 1, 3, 5, and 10 years for the whole cohort and 91% and 90% at 1 and 3 years for the recent half of the cohort. The majority of patient deaths after the perioperative period were not attributable to right ventricular failure (chronic thromboembolic pulmonary hypertension). At reassessment, a mean pulmonary artery pressure of ≥30 mm Hg correlated with the initiation of pulmonary vasodilator therapy post-PEA. A mean pulmonary artery pressure of ≥38 mm Hg and pulmonary vascular resistance ≥425 dynes·s(-1)·cm(-5) at reassessment correlated with worse long-term survival. CONCLUSIONS: Our data confirm excellent long-term survival and maintenance of good functional status post-PEA. Hemodynamic assessment 3 to 6 months and 12 months post-PEA allows stratification of patients at higher risk of dying of chronic thromboembolic pulmonary hypertension and identifies a level of residual pulmonary hypertension that may guide the long-term management of patients postsurgery.

Randomized clinical trial of negative pressure wound therapy for high-risk groin wounds in lower extremity revascularization.

OBJECTIVE: The surgical site infection (SSI) rate in vascular surgery after groin incision for lower extremity revascularization can lead to significant morbidity and mortality. This trial was designed to study the effect of negative pressure wound therapy (NPWT) on SSI in closed groin wounds after lower extremity revascularization in patients at high risk for SSI. METHODS: A single-center, randomized, controlled trial was performed at an academic tertiary medical center. Patients with previous femoral artery surgical exposure, body mass index of >30 kg/m2 or the presence of ischemic tissue loss were classified as a high-risk patient for SSI. All wounds were closed primarily and patients were randomized to either NPWT or standard dressing. The primary outcome of the trial was postoperative 30-day SSI in the groin wound. The secondary outcomes included 90-day SSI, hospital duration of stay, readmissions or reoperations for SSI, and mortality. RESULTS: A total of 102 patients were randomized between August 2014 and December 2015. Patients were classified as at high risk owing to the presence of previous femoral artery cut down (29%), body mass index of >30 kg/m2 (39%) or presence of ischemic tissue loss (32%). Revascularization procedures performed included femoral to distal artery bypass (57%), femoral endarterectomy (18%), femoral to femoral artery crossover (17%), and other procedures (8%). The primary outcome of 30-day SSI was 11% in NPWT group versus 19% in standard dressing group (P = .24). There was a statistically significant shorter mean duration of hospital stay in the NPWT group (6.4 days) compared with the standard group (8.9 days; P = .01). There was no difference in readmission or reoperation for SSI or mortality between the two groups. CONCLUSIONS: This study demonstrated a nonsignificant lower rate of groin SSI in high-risk revascularization patients with NPWT compared with standard dressing. Owing to a lower than expected infection rate, the study was underpowered to detect a difference at the prespecified level. The NPWT group did show significantly shorter mean hospital duration of stay compared with the standard dressing group.

Patency and limb salvage after femoral endarterectomy and iliac stenting are not affected by severity of iliac disease.

OBJECTIVE: The hybrid procedure of femoral endarterectomy and iliac artery stenting (FEIS) has been used as an alternative to traditional open surgical repair of iliofemoral arterial occlusive disease, but whether the severity of the iliac disease component affects long-term results is not well understood. METHODS: This was a retrospective cohort study of patients undergoing FEIS at Geisinger Health System from January 1, 2004, through December 31, 2013, for the treatment of symptomatic iliofemoral atherosclerotic occlusive disease. The cohort was stratified according to the severity of the iliac occlusive disease component into patients with mild iliac disease (group 1) and patients with severe iliac disease (group 2). RESULTS: Between January 1, 2004, and December 31, 2013, 99 patients underwent 111 total FEIS procedures. The mean age of the cohort was 67.4 years. Men composed 61% of patients. Indications for surgery were claudication (41%), ischemic rest pain (36%), and tissue loss (23%). At 5 years of follow-up, there was no difference in primary patency (73% in group 1 vs 68% in group 2 [P = .67]) and limb salvage (90% in group 1 vs 92% in group 2 [P = .51]). There was a trend toward higher overall mortality in group 2 patients vs group 1 patients (53% vs 81%; P = .08), but this did not reach statistical significance. Univariate analysis did not identify any device-related or anatomic factors predictive of patency. CONCLUSIONS: When combined iliofemoral arterial occlusive disease is treated with FEIS, the severity of the iliac disease component does not affect long-term patency or limb salvage.