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.

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.

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.

Pulmonary endarterectomy in the octogenarian population: safety and outcomes.

AIMS: Aim of the study was to verify the feasibility, safety and efficacy of pulmonary endarterectomy (PEA) in octogenarian patients with chronic thromboembolic pulmonary hypertension. METHODS: We retrospectively analyzed 635 chronic thromboembolic pulmonary hypertension patients who underwent PEA at our center and were followed-up for at least 1 year. The end-points of the study were in-hospital mortality, hemodynamic results at 1 year and long-term survival. RESULTS: In-hospital mortality was 4, 10 and 17%, respectively, for 259 patients under the age of 60 years, 352 aged between 60 and 79 years and 24 octogenarians (P = 0.006 octogenarians vs. <60 years). At multivariable analysis, age and pulmonary vascular resistances were independent risk factors for mortality (P = 0.021 and P < 0.001, respectively). At 1 year, the improvement in cardiac index was lower and the distance walked in 6 min was poorer for octogenarians than for the other two groups (both P = 0.001). Survival after hospital discharge was similar over a median follow-up period of 59 months (P = 0.113). Although in-hospital mortality and long-term survival are similar in octogenarians as compared with patients aged between 60 and 79, the improvement in cardiac index and in functional capacity at 1 year are lower in this very elderly population. CONCLUSION: Age over 80 years should not be a contraindication to PEA surgery in selected patients operated on in referral centers.

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.

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.

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.

Long-Term Outcomes of Coronary Endarterectomy in Patients With Complete Imaging Follow-Up.

Coronary endarterectomy (CEA) within coronary artery bypass grafting (CABG) is controversially discussed; however, CEA is considered as a last option for severely diseased coronary arteries. We therefore aimed to evaluate outcomes of patients undergoing CABG with CEA. We present a retrospective single surgeon's experience. Between 05/1999 and 12/2017, 426 patients underwent CABG with CEA. Follow-up imaging was proposed to all surviving patients, and only patients accepting were considered for this study. This resulted in a cohort of 112 patients within a mean postoperative interval of 53 ± 49 months. Study endpoints are graft patency, overall survival, and incidence of major-adverse-events. Mean patients' age was 65.5 ± 9.4 years; 90.2% were male. A total of 139 CEAs were performed (24 patients had more than 1 CEA-graft). Most of patients (91.1%) presented with 3-vessel disease. Mean syntax score was 29.8 ± 8.5. Four ± 1.3 grafts were constructed per patient; CEA target coronaries were either totally (31.9%) or subtotally (68.1%) occluded. CEA was performed at LAD- or RCA-territory (42.4% each) or LCX-territory (15.1%). Early postoperative outcomes reported stroke in 2 patients, myocardial infarction in 4 patients with 2 patients dying. Imaging follow-up reported 119 (out of 139) patent vs 20 occluded CEA-grafts (17 venous and 3 arterial). Long-term survival was 77.7% and freedom from major-adverse-events was 63.3% within mean follow-up time of 83 ± 67 months. Although CEA is a complex and second-line procedure, it offers a surgical option to allow myocardial revascularization in patients with diffuse or severe coronary artery disease. Good short- and long-term results can be achieved.

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.

Hybrid procedures and femoral endarterectomy in diabetic patients.

OBJECTIVE: The aim of the study is to evaluate the safety and effectiveness of common femoral endarterectomy (CFE) in critical limb ischemia (CLI) associated with proximal and distal endovascular (EV) revascularization in diabetic (type 1 and type 2) and non-diabetic patients. PATIENTS AND METHODS: We analyzed patients from January 2008 to December 2011 who underwent one-staged hybrid procedures. Patients were divided into three groups: group 1 = EV reconstruction proximal to the CFE, group 2 = EV procedures distal to the CFE, group 3 = both proximal and distal EV procedures. Patients were evaluated at 6 and 36 months after the procedures, and the mean follow-up was 42 ± 20.3 months. RESULTS: A total of 43 (79% men; aged 74.4 ± 8.6 years) out of 635 (5.5%) patients operated for CLI fulfilled the inclusion criteria; 23 (53.5%) had type 1 or type 2 diabetes mellitus (DM). DM patients were younger than controls (p = 0.048). The patient distribution was 14 in Group 1 (32.5%), 24 in Group 2 (55.8%) and 5 in Group 3 (11.7%). CFE was successful in all cases, while associated EV procedures were successful in 90.7% of patients. Peri-operative morbidity and mortality were 11.6% and 2.3%, respectively. Survival rates at 6 and 36 months were 93% and 71.9%, respectively. Three patients (6.98%) underwent a major amputation. The cumulative limb salvage was 95.2% at 6 months and 92.1% at 36 months. No recurrent CFE stenosis was observed. No differences in survival, amputation or patency rates emerged between DM and non-DM patients or among the three EV revascularization groups. CONCLUSIONS: Hybrid procedures are safe and effective both in CLI patients with or without DM, and they should be taken into consideration whenever indications are present.

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.

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.

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.

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.

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.

Outcomes and prognostic factors for postsurgical pulmonary vein stenosis in the current era.

BACKGROUND: The optimal management and prognostic factors of postsurgical pulmonary vein stenosis remain controversial. We sought to determine current postsurgical pulmonary vein stenosis outcomes and prognostic factors in a multicentric study in the current era. METHODS: Seventy-five patients with postsurgical pulmonary vein stenosis who underwent 103 procedures in 14 European/North American centers (2000-2012) were included retrospectively. A specific pulmonary vein stenosis severity score was developed on the basis of the assessment of each pulmonary vein. End points were death, pulmonary vein reintervention, and restenosis. A univariate and multivariate risk analysis was performed. RESULTS: Some 76% of postsurgical pulmonary vein stenosis occurred after repair of a total anomalous pulmonary venous return. Sutureless repair was used in 42 of 103 procedures (41%), patch veinoplasty was used in 28 procedures (27%), and endarterectomy was used in 16 procedures (16%). Overall pulmonary vein restenosis, reintervention, and mortality occurred in 56% (n = 58/103), 49% (n = 50/103), and 27% (n = 20/75), respectively. Sutureless repair was associated with less restenosis (40% vs 67%; P = .007) and less reintervention (31% vs 61%; P = .003). Mortality after sutureless repair (20%; 7/35) tends to be lower than after nonsutureless repair (33%; 13/40) (P = .22). A high postoperative residual pulmonary vein stenosis score at the time of hospital discharge was an independent risk factor for restenosis (hazard ratio [HR], 1.55; P < 10-4), reintervention (HR, 1.33; P < 10-4), and mortality (HR, 1.37; P < 10-4). The sutureless technique was an independent protective factor against restenosis (HR, 0.27; P = .006). CONCLUSIONS: Postsurgical pulmonary vein stenosis still has a guarded prognosis in the current era. The sutureless technique is an independent protective factor against restenosis. The severity of the residual disease evaluated by a new severity score is an independent risk factor for poor outcomes regardless of surgical technique.

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.

[Analysis of mortality and hospital stay in cardiac surgery in Mexico 2015: Data from the National Cardiology Institute]. / Análisis de mortalidad y estancia hospitalaria en cirugía cardiaca en México 2015: datos del Instituto Nacional de Cardiología.

OBJECTIVE: To analyse hospital mortality in patients subjected to cardiac surgery in Mexico during the year 2015, and identify the mortality risks factors, and its correlation with days of hospital stay in the cardiovascular intensive care unit. METHOD: The database of Cardiovascular Intensive Care of the National Institute of Cardiology was examined for this cases and controls study that included only adult patients subjected to cardiac surgery during the year 2015. RESULTS: A total of 571 patients were subjected to a surgical procedure. The predominant indication was single or multiple valve replacement surgery, followed by coronary revascularisation surgery, and correction of adult congenital heart disease. Overall mortality was 9.2, and 8% died in intensive care. The main risk factors for death were preoperative organ failure or pulmonary hypertension, and prolonged time with extracorporeal circulation. The primary cause of death was secondary to cardiogenic shock. The hospital mortality observed in this population was higher for patients undergoing pulmonary thromboendarterectomy, complex aortic disease surgery, and valvular surgery. CONCLUSIONS: The mortality of patients undergoing cardiac surgery in Mexico differs slightly from that reported in the world literature, primarily because there were more multivalvular surgeries and mixed complex procedures performed.

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.