The Enzen Trial: Analysis of EVAR Endoprosthesis Zenith and Endurant for Infrarenal Aortoiliac Aneurysms Regarding Outcomes, Endoleaks, and Reinterventions.

OBJECTIVE: The main objective of this paper is to analyze the outcomes regarding endoleaks, reinterventions, and death related to aneurysm complications in patients submitted to endovascular repair (EVAR) for abdominal aortoiliac aneurysm (AAA) using Endurant II (Medtronic) and Zenith Flex (Cook) endografts. METHODS: This was a prospective, consecutive cohort study of patients with AAA who underwent EVAR between January 2019 and December 2022. Two groups of patients were evaluated: Group Endurant (patients submitted to EVAR with the use of Endurant II) and Group Zenith (patients submitted to EVAR with the use of Zenith Flex). RESULTS: A total of 156 patients were evaluated. Group Zenith (67 patients, 42.9%) and Group Endurant (89 patients, 57.1%). The perioperative mortality was 5.1%, eight patients (six patients Group Zenith, and two patients Group Endurant, p=0.054). There were 28 patients (17.9%) submitted to urgent repair of the aneurysm (expansion or rupture), with no differences among the groups. There were 36 cases (23.1%) of later endoleak, with a higher incidence in Zenith group (23 patients, 34.3%) than Endurant group (13 patients, 14.6%, p=0.002), most of them Type II endoleak (21 patients, 13.4%). There were 12 cases of Type I endoleak, also with a higher prevalence in Zenith group (13.4%) than Endurant group (3.4%, p=0.002). Moreover, regarding limb graft occlusion (LGO), there were nine patients (5.8%), with a higher prevalence in Zenith group (9%) than Endurant group (3.4%, p=0.045). The overall survival in a Kaplan-Meier at 720 days was 82.3% in the Zenith group and 89.1% in the Endurant group, with no statistical significance among the groups (p=0.09). The freedom from reintervention rates in a Kaplan-Meier at 720 days was 82.8% in the Zenith group and 93.2% in the Endurant group (p=0.001). CONCLUSION: In this present study, Zenith endograft had higher rates of endoleaks, aneurysms related mortality, LGO and reinterventions than patients submitted to Endurant II endografts. The linear regression analysis showed that the presence of endoleaks, type of endograft device (Zenith graft) and limb graft occlusion were related to higher reintervention rates. CLINICAL IMPACT: In this present study, Zenith endograft had higher rates of endoleaks, aneurysms related mortality, limb graft occlusions and reinterventions than patients submitted to Endurant II endografts. The main impact and the innovation that this article provides is an opportunity to evaluate and choose the best endograft suitable for the patient with AAA during EVAR.

The Importance of the Circle of Willis in Carotid Interventions Outcomes: A Real-Life Study.

BACKGROUND: The main objective of this study is to evaluate and compare the outcomes regarding operative mortality rate, ipsilateral stroke, and overall survival rate among patients with internal carotid artery stenosis submitted to carotid endarterectomy (CEA) or stenting regarding the completeness of circle of Willis (CoW). METHODS: Prospective, consecutive cohort study of patients submitted to carotid interventions (CEA and carotid stenting: CAS) for internal carotid artery stenosis diagnosis evaluated according complete or incomplete CoW. The patients were divided into 2 groups: group I, the patients with complete CoW and group II, the patients with incomplete CoW, with the disruption of anterior and/or ipsilateral posterior circulation, regarding the ipsilateral significant carotid stenosis. RESULTS: Overall, 98 patients submitted to carotid intervention were evaluated. Two groups of patients were identified: group CoW complete with 54 patients and group CoW incomplete with 44 patients. Regarding the type of intervention, the prevalence of CAS in CoW complete group and CoW incomplete group were statistically similar (54.1% vs. 55.1%, P = 0.22). Notwithstanding, CEA was also statistically similar in CoW incomplete group and CoW complete group (44.2% vs. 45.9%, P = 0.22). The perioperative mortality rate was 2% in total cohort (2 patients), with no differences among CoW complete and incomplete groups (3.7% vs. 0%, P = 0.50, respectively). Furthermore, the incidence of postoperative stroke was 3.1% (asymptomatic 2%, symptomatic 1.1%), with no differences among CoW complete and incomplete groups (3.7% vs. 2.3%, P = 0.68, respectively). A univariate and multivariate linear regression showed that among the factors evaluated, only chronic kidney failure was related with hazard ratio = 1.89, P = 0.003, confidence interval 1.058-2.850. CONCLUSIONS: The completeness of the CoW, independently of the type of carotid intervention (CEA and CAS), did not interfere in the results regarding postoperative outcomes for stroke and death. Chronic kidney disease was associated to increased risk of perioperative stroke.

The Importance of the Hypogastric Artery Preservation during Treatment for Aortoiliac Aneurysms: A Prospective Single-Center Study.

BACKGROUND: To determine the importance of the hypogastric artery for the outcomes of survival, endoleaks, reinterventions, buttock claudication (BC), and perioperative mortality rate (PMR) in patients with aortoiliac aneurysms (AIA) receiving endovascular or open surgical (OS) repair. METHODS: This was a prospective consecutive cohort study of patients with AIA who underwent endovascular treatment or OS repair during the period of 2010-2021. Endovascular repair was performed with use of aortoiliac endoprosthesis associated with internal iliac artery (IIA) coil embolization and/or with iliac branch endoprosthesis (IBE) in order to preserve the IIA. The AIA OS repairs were performed with the artery ligation in order to exclude the IIA, or in some cases, the exclusion of the IIA was performed with an endosuture in the proximal stump of the artery. Three groups were identified in the postprocedural period: group 0 (no hypogastric arteries (HAs) preserved), group 1 (1 hypogastric artery preserved), and group 2 (2 hypogastric arteries preserved). RESULTS: A total of 91 patients were submitted to OS or endovascular surgery. Regarding the HA patency, there were 17 patients in group 0, 45 patients in group 1, and 29 patients in group 2. There were 17 cases of bowel ischemia (BI) (94.1% in group 0, 5.9% in group 1, and no cases in group 2, P < 0.001) most of them in group 0, with statistical significance, 12 cases of BC (91.7% in group 0, 8.3% in group 1, and no cases in group 2, P < 0.001), most of them in group 0, with statistical significance. The perioperative mortality was 14.3%, 13 patients (9 patients - 52.9% group 0, 3 patients - 6.7% group 1, and 1 patient - 3.4% group 2, P < 0.001). The linear regression analysis for survival rates showed that BI [P = 0.026 to hazard ratio (HR) = 1.69], emergency aortoiliac repair (P < 0.001, HR = 8.86), and number of HAs (P < 0.001, HR = 5.46) in postoperative were related to poorer survival rates in both univariate and multivariate analysis. The linear regression analysis showed that the number of HAs (P < 0.001, HR = 3.61) in postoperative, emergency aortoiliac repair (P = 0.002, HR 3.233), and cardiac disease (P = 0.048, HR = 3.84) were related to BI. CONCLUSIONS: In conclusion, the number of HA is crucial for adequate and safe outcomes after abdominal aortic aneurysm (AAA) repair. The main factors related to death were BI, emergency aortoiliac repair, and the number of HAs preserved. Moreover, the main factors related to BI were the number of HAs in postoperative, emergency aortoiliac repair, and cardiac disease.

A Comparative Analysis and Results of Carotid Interventions Based on Duplex Ultrasound as a Single Exam Versus Multiple Diagnose Exams.

BACKGROUND: To determine the results, safety, and clinical outcomes of carotid interventions performed with duplex ultrasound (DUS) as a single preoperative image for internal carotid artery (ICA) assessment, compared to computed tomography angiography (CTA) and magnetic resonance angiography (MRA). METHODS: Prospective, consecutive cohort study of 2 groups of patients submitted to carotid interventions, 1 group of patients with DUS as a sole exam (group DUS) compared to patients with DUS plus CTA or MRA for ICA stenosis diagnosis (group CTA/MRA) regarding clinical outcomes such as major stroke, minor stroke, transient ischemic attack and perioperative mortality. RESULTS: Two groups of patients were identified: group DUS with 47 patients and group CTA/MRA plus DUS with 68 patients. The mean age of the patients was 71.67 years in total cohort, and most of them were male (66.1%). Group DUS had higher prevalence of male, dyslipidemia, ischemic heart disease, peripheral artery disease and chronic kidney disease than group CTA/MRA (83% vs. 54.4%, P = 0.001; 93.6% vs. 51.5%, P < 0.001; 36.2% vs. 16.2%, P = 0.009; 29.8% vs. 13.2%, P = 0.019; 14.9% vs. 5.9%, P = 0.007, respectively). We have performed a Kaplan-Meier regarding survival rates: Group DUS had 93.5%% and Group CTA/MRA had 90.3%% at 720 days. P = 0.15, standard error < 10 at 720 days. a Kaplan-Meier analysis regarding primary patency rates showed Group DUS with 92.7% and Group CTA/MRA with 94.7% at 720 days. P = 0.78, standard error < 10 at 720 days. Furthermore, the incidence of postoperative stroke was 2.6% (asymptomatic 1.7%, symptomatic 2.9%), with no differences among DUS and CTA/MRA groups (2.1% vs. 2.9%, P = 0.78, respectively). CONCLUSIONS: Independently of the type of carotid intervention (carotid endarterectomy and carotid stenting (CAS)), DUS as an only preoperative carotid image has similar results regarding postoperative outcomes when compared to CTA/MRA for preoperative carotid evaluation.

Acute Arterial Occlusions in COVID-19 Times: A Comparison Study Among Patients with Acute Limb Ischemia With or Without COVID-19 Infection.

BACKGROUND: To determine the impact of coronavirus (COVID-19) infection in patients with acute limb ischemia (ALI), mainly the limb salvage estimates the rate and the overall survival rate. METHODS: This was a prospective, consecutive cohort study of ALI patients with or without COVID-19 infection. Two groups of patients were identified: patients with ALI and COVID-19 infection and patients with ALI and without COVID-19 infection. The comparisons among the 2 groups were performed with proper statistical analysis methods. RESULTS: Two groups of patients were identified: ALI and COVID-19 infection with 23 patients and ALI without COVID-19 infection with 49 patients. The overall mortality rate (OMR) was 20.8% (15 patients) in total cohort within the first 30 days. COVID-19 group had a higher OMR than non-COVID-19 group (30.4% vs. 16.7%, P = 0.04). The limb salvage rate at 30 days was 79.1% in total cohort; however, non-COVID-19 infection group had higher limb salvage rates than COVID-19 infection group (89.7% vs. 60.8%, P = 0.01). A univariate and multivariate logistic regression was performed to test the factors related to a major amputation rate. Among the factors evaluated, the following were related to limb loss: D-dimer > 1,000 mg/mL (hazards ratio [HR] = 3.76, P = 0.027, CI = 1.85-5.89) and COVID-19 infection (HR = 1.38, P = 0.035, CI = 1.03-4.75). Moreover, a univariate and multivariate logistic regression analysis was performed to analyze the factors related to overall mortality. Among the factors evaluated, the following were related to OMR: D-dimer > 1,000 mg/dL (HR = 2.28, P = 0.038, CI: 1.94-6.52), COVID-19 infection (HR = 1.8, P = 0.018, CI = 1.01-4.01), and pharmacomechanical thrombectomy >150 cycles (HR = 2.01, P = 0.002, CI = 1.005-6.781). CONCLUSIONS: COVID-19 has a worse prognosis among patients with ALI, with higher rates of limb loss and overall mortality relative to non-COVID patients. The main factors related to overall mortality were D-dimer > 1,000 mg/dL, COVID-19 infection, and pharmacomechanical thrombectomy >150 cycles. The factors related to limb loss were D-dimer > 1,000 mg/mL and COVID-19 infection.

WIfI Classification Versus Angiosome Concept: A Change in the Infrapopliteal Angioplasties Paradigm.

OBJECTIVE: The objective of this study was to determine whether the angiosome concept and WIfI classification in patients undergoing endovascular treatment is associated with the limb salvage rate and wound healing rate in patients with critical limb ischemia(CLI). METHODS: This was a retrospective, consecutive cohort study of CLI patients who underwent infrapopliteal angioplasty at the Vascular and Endovascular Surgery Service of the Hospital do Servidor Público Estadual, São Paulo, between January 2013 and January 2019. The primary outcome variable was the limb salvage rate and wound healing rate. The secondary outcome variables were patency, survival, time free from reintervention, and operative mortality rate. RESULTS: Overall, 95 infrapopliteal endovascular procedures were performed in 95 patients. The initial technical success rate was 100%. The mean ± standard deviation outpatient follow-up time was 775 ± 107.5 days. The analyses were performed at 360 days for wound healing rate and 720 days for limb salvage rates, overall survival, and time freedom from reintervention. According to the angiosome concept, there were 54 patients (56.8%) classified in the direct group and 41 patients (43.2%) in the indirect group. Regarding the WIfI classification subanalysis, there were 22 patients WIfI 0-1 (23.2%) and 73 patients WIfI 2-3 (76.8%). Furthermore, the indirect group had a higher ulcer healing rate than the direct group; however, it was not statistically significant (82.9%; 66.7%%, respectively, P = 0.059). However, the time to heal the ulcer was faster in the WIfI 0-1 groups than WIfI 2-3 groups (164.82 days versus 251,48; P = 0.017). The limb salvage rates at 720 days were similar among indirect and direct Groups (92.6% and 85.4%, P = 0.79). Likewise, the freedom from reintervention rates at 720 days were also similar in Indirect and direct groups (74.6% and 64%, P = 0.23). The survival rates at 720 days were similar in both indirect and direct groups (86.8 and 85.6%, respectively; P = 0.82). The amputation free survival rate at 720 days by the Kaplan-Meier method was 91.3% in the indirect group and 85.9% in the direct group, but with no statistical significance between the groups (P = 0.37) CONCLUSIONS: This study concluded that, in endovascular treatment, the angiosome concept is no longer important to limb salvage rates, nor ulcer/wound healing rates. Moreover, the WIfI classification 0-1 is associated with faster and higher wound/ulcer healing rates than WIfI classification 2-3.

Ultrasound Aspects and Recanalization Rates in Patients with Lower-Limb Deep Venous Thrombosis Treated with Rivaroxaban.

BACKGROUND: In this article, we report the ultrasound aspects and recanalization rates of patients with deep venous thrombosis (DVT) in the lower limbs treated with the rivaroxaban, focusing on the recanalization rate and the ultrasonographic aspects. METHODS: This was a prospective and consecutive cohort study of patients admitted with DVT who were submitted to treatment with rivaroxaban for 6 months at the Division of Vascular and Endovascular Surgery, Hospital do Servidor Público Estadual, São Paulo, Brazil, between March 2016 and July 2018. RESULTS: Fifty-one patients with DVT were admitted to the Vascular Surgery Department and received rivaroxaban for 6 months. The follow-up time was 360 days. Analyses were performed at 180 and 360 days. The rate of total venous recanalization at 360 days was 76.4% (39 patients). The incidence of partial venous recanalization was 23.5% (12 patients). At the first month, 11 patients (21.7%) continued with total occlusion of the vein, with 4 patients (6.5%) with no residual thrombi. However, at 6 months, only 2 patients (2.2%) continued with total occlusion of the vein, with 26 patients (47.8%) with no residual thrombi. At 12 months, there were 39 patients (76.4%) with no residual thrombi. Univariate and multivariate logistic regression identified the following factors related to total venous recanalization: the absence of popliteal vein reflux (odds ratio [OR], 0.386; P = 0.007), no residual thrombi (OR, 3.213; P = 0.008), femoropopliteal clot length at 1 month (OR, 3.021; P = 0.016), femoropopliteal clot length at 6 months (OR, 2.234; P = 0.008). The incidence of post-thrombotic syndrome (PTS) at 12 months was 8.3%. CONCLUSIONS: In this study, patients who received oral rivaroxaban displayed satisfactory total vein recanalization rate after 6 months and 12 months. The factors associated with better total recanalization rates were the absence of popliteal vein reflux, the absence of residual thrombi in the veins, femoropopliteal clot length at 1 month (OR, 3.021; P = 0.016), and femoropopliteal clot length at 6 months (OR, 2.234; P = 0.008). Moreover, the incidence of PTS at 12 months was 8.3%.

Analysis of the Safety and Efficacy of the Endovascular Treatment for Acute Limb Ischemia with Percutaneous Pharmacomechanical Thrombectomy Compared with Catheter-Directed Thrombolysis.

BACKGROUND: To evaluate the rates of limb salvage, survival, and perioperative mortality in patients with acute limb ischemia (ALI) submitted to endovascular revascularization with pharmacomechanical thrombectomy (PMT) and catheter-directed thrombolysis (CDT). METHODS: This was a retrospective consecutive cohort study of patients with ALI who were submitted to endovascular treatment with PMT or fibrinolysis at the Division of Vascular and Endovascular Surgery, Hospital do Servidor Público Estadual (São Paulo, Brazil), between July 2015 and December 2018. The limb salvage rate and survival rate at 720 days were analyzed in both the PMT (group 1) and CDT treatment (group 2), as well as the perioperative mortality rate (PMR) at 30 days after surgery. RESULTS: One hundred twelve patients were admitted to the emergency department with ALI between July 2015 and December 2018. Seventeen patients diagnosed with Rutherford III irreversible ALI and 46 patients submitted to open surgery were excluded. Thus, 49 patients were submitted to endovascular surgery; 18 (36.7%) were classified into group 1, and 31 (63.3%) were classified into group 2. The clinical data were equal between the 2 groups, but there was a higher prevalence of thrombophilia in group 1 (3 cases; P < 0.001). The limb salvage rate and the overall survival rate at 720 days were similar between groups 1 and 2 (87.8% vs. 89.7%, P = 0.78 and 84.7% vs. 69.2%, P = 0.82, respectively). There was no statistical difference regarding secondary patency rates at 720 days between groups 1 and 2 (group 1, 81.9% and group 2, 78.8%; P = 0.66). The PMR was 16.7% (8 patients) within the first 30 days. Group 2 had a higher overall mortality rate (OMR) (6 patients, 19.3%, P = 0.03). Regarding the PMT group, there was a higher rate of complications such as myoglobinuria, hematuria, acute renal failure, and death in the subgroup of patients in whom there were performed more than 150 cycles/sec during the surgery (P < 0.001). CONCLUSIONS: In the present study, the PMT and CDT endovascular procedures had similar limb salvage, overall survival, and secondary patency rates. However, the OMR was higher in the CDT group. Another important finding was related to the number of cycles/sec performed in the PMT group, in whom patients with more than 150 cycles/sec have presented with higher rates of hematuria, myoglobinuria, acute renal failure, and death.

Analysis of the results of endovascular and open surgical treatment of acute limb ischemia.

OBJECTIVE: The objective of this study was to evaluate the long-term estimates of limb salvage and survival in patients with acute limb ischemia (ALI) receiving open surgery or endovascular revascularization. METHODS: This was a retrospective consecutive cohort study of patients with ALI who underwent open surgery or endovascular treatment at the Vascular and Endovascular Surgery Unit, Hospital do Servidor Público Estadual (São Paulo, Brazil), between July 2010 and July 2016. The overall mortality, limb salvage, and survival rates at 720 days were analyzed in both the open surgery (group 1) and endovascular treatment (group 2) groups. RESULTS: A total of 69 patients were admitted for a limb salvage procedure. The mean follow-up period was 822 ± 480.5 days. All of the analyses were performed at 720 days. Of the 69 patients, 46 (66.6%) were in group 1 and 23 (33.4%) in group 2. The clinical characteristics were similar between the groups, except for higher rates of chronic kidney disease (P = .04) and arrhythmia (P = .01) in group 1. Group 1 had a higher postoperative ankle-brachial index (P = .03). Concerning the Rutherford classification, group 1 had a higher prevalence of Rutherford IIB ALI (P = .003). The preoperative creatine kinase level was higher in group 1 than in group 2 (780 [range, 198-6546] mg/dL and 245 [65-78] mg/dL, respectively). A creatine kinase level >200 mg/dL was seen in 65.2% and 47.8% of patients in group 1 and group 2, respectively (P = .028). The limb salvage and overall survival estimates at 720 days were similar between group 1 and group 2 (79.2% vs 90.6% [P = .27] and 53% vs 60.8% [P = .45], respectively). The overall mortality rate was 10.1% (seven patients) within the first 30 days, and it was higher in group 1 (six patients [13.0%]; P = .03). CONCLUSIONS: Both open surgery and endovascular procedures are safe treatments of patients with ALI, with acceptable limb salvage and survival rates. No previous study has suggested the preferred treatment of ALI. However, based on this study and the overall literature, endovascular treatment may be the preferred treatment of patients with Rutherford I and IIA ALI; open surgery may be the best option for ALI due to arterial embolism and for Rutherford IIB acute arterial thrombosis because of a greater urgency to restore blood flow.

Evaluation of the BASIL Survival Prediction Model in Patients Undergoing Infrapopliteal Interventions for Critical Limb Ischemia.

BACKGROUND: Survival prediction models are clinical tools that help professionals make the best treatment decisions. In the treatment of critical limb ischemia, several scoring methods have emerged; however, many are limited because they are not reproducible in different populations. This study analyze the Bypass versus Angioplasty in Severe Ischemia of the Leg survival prediction model (BASIL SPM), exclusively in patients who underwent infrapopliteal (InfraPo) revascularization for the treatment of critical limb ischemia. METHODS: In this retrospective cohort, patients who underwent InfraPo interventions during a 4-year period (2009-2013) were consecutively included, according to the primary intervention (endovascular or open repair), irrespective of combined treatment in the femoropopliteal and InfraPo segments. Performance of the BASIL SPM was determined using the area under the curve of the receiver-operating characteristic curve. Additionally, secondary patency, limb salvage, and overall survival were analyzed by the Kaplan-Meier method. RESULTS: The mean follow-up duration was 32.7 ± 23.8 months. In the total patient group (n = 134), the mean age was 72 ± 8.6 years (range, 46-91 years), and the main associated comorbidities were hypertension (85.8%) and diabetes mellitus (76.8%). Regarding differences between the groups, patients in the endovascular group (n = 100) were older (73 vs. 69.5; P = 0.033) and more frequently stratified as high risk (61% vs. 38.2%; P = 0.030) than the open repair group (n = 34). The area under the curve (95% confidence interval [CI]) using the BASIL SPM at 6, 12, and 24 months was 0.499 (95% CI: 0.344-0.657), 0.508 (95% CI: 0.353-0.629), and 0.549 (95% CI: 0.420-0.678), respectively. In the total patient group, the 36-month secondary patency, limb salvage, and overall survival were 31.5%, 81.1%, and 65.9%, respectively. CONCLUSIONS: The BASIL SPM was a poor predictor of life expectancy in this patient cohort.

The importance of the superficial and profunda femoris arteries in limb salvage following endovascular treatment of chronic aortoiliac occlusive disease.

OBJECTIVE: This study aimed to report the long-term limb salvage, survival and patency rates of endovascular treatment for aortoiliac occlusive disease (AIOD) when outflow was achieved through the profunda femoris artery (PFA) only vs both the PFA and superficial femoral artery (SFA). METHODS: From January 2008 to July 2016, patients with AIOD who underwent aortoiliac angioplasty at the Division of Vascular and Endovascular Surgery, Hospital do Servidor Público Estadual, São Paulo, Brazil, were classified into two groups according to whether they had femoral outflow via the PFA only (group 1) or both the PFA and SFA (group 2) in the affected leg. The primary outcome was amputation-free survival. The secondary outcomes were the patency and overall survival rates. RESULTS: In total, 69 aortoiliac angioplasties were performed in 69 patients: 22 patients (31.8%) in group 1 and 47 (67.2%) in group 2. A total of 12 reinterventions (17.4%) were performed, seven (31.8%) in group 1 and five (10.2%) in group 2, without statistical significance between the groups (P = .063). The mean clinical follow-up period was 2500 ± 880.5 days. Both the primary and secondary patency rates analyzed at 1800 days were similar between groups 1 and 2 (80.2% vs 82.3%; P = .80 and 84.7% vs 97.6%; P = .10, respectively). Furthermore, the limb salvage rates at 1800 days were similar between groups 1 and 2 (91.3% vs 86.1%; P = .60), as were the survival rates (74.7% vs 78%; P = .80). The Bollinger score was worse in group 1 (P = .001), as expected, because of occlusion of the SFA. However, the PFA and popliteal artery scores were similar between the two groups. Occlusion of the SFA did not influence the limb salvage rate according to univariate analysis (P = .509) and multivariate Cox regression analysis (P = .671). CONCLUSIONS: The patency of the SFA does not interfere with the outcomes of endovascular treatment for chronic AIOD. The PFA in conjunction with the popliteal artery as the sole outflow route for iliac endovascular treatment is associated with similar patency, survival, and limb salvage rates as those for outflow through both the PFA and SFA.

Number of infrapopliteal arteries undergoing endovascular treatment is not associated with the limb salvage rate in patients with critical limb ischemia.

OBJECTIVE: The objective of this study was to determine whether the number of infrapopliteal arteries undergoing endovascular treatment is associated with the limb salvage rate in patients with critical limb ischemia (CLI). METHODS: This was a retrospective, consecutive cohort study of CLI patients who underwent infrapopliteal angioplasty at the Vascular and Endovascular Surgery Service of the Hospital do Servidor Público Estadual, São Paulo, between January 2009 and January 2013. The primary outcome variable was the limb salvage rate. The secondary outcome variables were patency, survival, plantar arch quality, and operative mortality rate. RESULTS: Overall, 109 infrapopliteal angioplasties were performed in 92 patients, and the initial technical success rate was 95.6%. Based on the analyses of the arteriography of the endovascular procedures, the patients were classified into two groups according to whether they had undergone endovascular treatment of one artery (group 1) or two arteries (group 2). The mean outpatient follow-up time was 430 ± 377.5 days. The analyses were performed at 180 and 360 days. There were 72 angioplasties (66%) in group 1 and 37 (34%) in group 2. Hypertension was more frequent in group 1 (93.1%) than in group 2 (78.4%; P = .03). Other clinical characteristics were similar in both groups. Regarding postoperative complications, the incidence of acute kidney failure was lower in group 1 (0% vs 8.1%, respectively; P = .037). The limb salvage rate at 360 days was similar in groups 1 and 2 (89.4% vs 89.3%, respectively; P = .595). The secondary patency rate at 360 days was also similar in groups 1 and 2 (59.9% vs 60.9%, respectively; P = .571). The perioperative mortality rate was lower in group 1 (4.2% vs 16.2%, respectively; P = .039), but the survival rate at 360 days was similar in both groups (82.1% vs 75.1%, respectively; P = .931). The frequencies of complete, incomplete, and absent plantar arch were similar in both groups. The estimated limb salvage rates for patients with complete plantar arch or incomplete/absent plantar arch were 96.2% and 84.6%, respectively (P = .467), at 360 days. CONCLUSIONS: Our results suggest that it is not necessary to treat the largest number of arteries possible in CLI patients. Instead, the most amenable artery for endovascular procedures should be treated to improve limb salvage and secondary patency rates.

Results of bypass graft surgery after prior angioplasty in critical limb ischaemia treatment.

BACKGROUND: The aim of this study was to determine the outcomes of primary bypass graft surgery (BGS) compared to BGS after failed angioplasty (PTA). PATIENTS AND METHODS: Between January 2007 and January 2014, we performed 136 BGSs exclusively for the treatment of critical limb ischaemia. Two cohorts were identified: 1) primary BGS (n = 102; group I), and 2) BGS after prior PTA (n = 34; group II). Data were analysed retrospectively and the primary endpoints were the rates of secondary patency, amputation-free survival, freedom from major adverse outcomes (graft occlusion, amputation, or death), and overall survival, which were assessed with the Kaplan-Meier method. RESULTS: Both groups were comparable with a predominance of Rutherford's category 5 ischaemic lesions (73.3 %). Most patients had extensive TASC D athe-rosclerotic disease (83.6 %), and the main conduit was the greater saphenous vein (58.1 %). The mean follow-up time was 36.2 months. The 3-year secondary patency rates were better for group I (64.3 % vs 49.6 %; P = 0.04). During the same period, the amputation-free survival rates were similar between the groups (77.4 % vs 74.5 %; P = 0.59). For multivariate Cox regression analysis, BGS after prior PTA was the only factor associated with re-intervention for limb salvage (hazard ratio = 2.39; CI 95 % = 1.19 - 4.80; P = 0.02). At the 3-year point, there were no differences in the overall survival rates (72.6 % vs 70 %; P = 0.97), but the proportion of patients without adverse outcomes was higher in group I (37.3 % vs 13.4 %; P = 0.007). CONCLUSIONS: Although secondary patency was better after primary BGS, the amputation-free and overall survival rates support the use of BGS after prior PTA.

The catastrophic impact of COVID-19 infection in patients with chronic limb-threatening ischemia.

BACKGROUND: To determine the impact of COVID-19 infection in patients with chronic limb-threatening ischemia, mainly the limb salvage estimates rate and the overall survival. METHODS: This was a retrospective, consecutive cohort study of chronic limb-threatening ischemia in patients with COVID-19 infection. RESULTS: Overall, 35 patients with chronic limb-threatening ischemia and COVID-19 infection were evaluated. The mean age of the patients was 72.51 years, and most of them were male (60%), with arterial hypertension (85.7%), followed by diabetes mellitus (80%) and tobacco user (71.4%). There was a higher prevalence of wound, ischemia and foot infection (WIfI) classification 4 with 58.8% and Rutherford grade 5 (74.3%). The factors related to overall mortality rate were: D-dimer >1,000 mg/dL (hazard ratio = 22.7, P < .001, confidence interval = 10.49-26.52), respiratory symptoms (hazard ratio = 16.6, P < .001, confidence interval = 9.87-20.90), chest computed tomography compromising higher than 50% of the pulmonary tract (hazard ratio = 16,0, P < .001, confidence interval = 10.41-20.55), acute kidney failure (hazard ratio = 21.58, P < .001, confidence interval = 16.5-30.5), chronic kidney disease (hazard ratio = 4.4, P = .036, confidence interval = 1.45-10.1), therapeutic anticoagulation (hazard ratio = 8.37, P = .004, confidence interval = 1.35-8.45), and WIfI classification (hazard ratio = 5.28, P = .022, confidence interval = 1.34-10.01). The following were related to limb loss: D-dimer >1,000 mg/mL (hazard ratio = 5.47, P = .02, confidence interval = 1.94-10.52), respiratory symptoms (hazard ratio = 5.42, P = .02, confidence interval = 1.87-10.90), and WIfI classification (hazard ratio = 4.44, P = .035, confidence interval = 1.34-8.01). CONCLUSION: This study concluded that COVID-19 has a catastrophic impact among patients with chronic limb-threatening ischemia. The main factors related to overall mortality were D-dimer >1,000 mg/dL, respiratory symptoms, chest computed tomography compromising higher than 50% of the pulmonary tract, acute kidney failure, chronic kidney disease, therapeutic anticoagulation, and WIfI classification. The factors related to limb loss were WIfI classification, D-dimer >1,000 mg/mL and respiratory symptoms.

Microbiology of Diabetic Foot Infections in a Tertiary Care Hospital in São Paulo, Brazil.

Diabetic foot infections (DFIs) are one of the causes of hospitalization in diabetic patients and, when this occurs, empirical antibiotic therapy is necessary. We have conducted a retrospective study of patients with DFI that required hospitalization to evaluate microbiologic profile and the susceptibility pattern of these infections. We evaluated 320 patients, of which 223 (69.7%) were male with a media age of 71 years with 276 isolates. Gram-positive bacteria were responsible for 188 (68.1%) of the isolates, while Gram-negative bacilli were responsible for 88 (31.9%). E. faecalis was the most prevalent pathogen, followed by S. aureus and coagulase negative Staphylococci. Among Gram-negative pathogens, P. aeruginosa was the most prevalent agent. Regarding the susceptibility profile, we found ampicillin-sensitive enterococci in 89% of the cases, oxacillin-sensitive S. aureus in 47%, but in coagulase-negative staphylococci, oxacillin was sensible only in 20%. The susceptibility profile of Gram-negatives was very good with 76% susceptibility of P. aeruginosa to ceftazidime and meropenem. The other prevalent Enterobacterales had great susceptibility to ceftazidime, piperacillin-tazobactam and 100% susceptibility to meropenem, with the exception of K. pneumoniae, which had 75% susceptibility to meropenem. Knowledge of microbiological profile and susceptibility patterns of patients with DFIs is useful to guide empirical therapy.

Comparison of the recanalization rate and postthrombotic syndrome in patients with deep venous thrombosis treated with rivaroxaban or warfarin.

BACKGROUND: In this article, we report the outcomes of patients with deep venous thrombosis in the lower limbs treated with the oral anticoagulant rivaroxaban or warfarin, focusing on the recanalization rate (measured with duplex ultrasound) and the incidence of postthrombotic syndrome. METHODS: This was a prospective, consecutive, randomized, blind cohort study of patients admitted with deep venous thrombosis to the Division of Vascular and Endovascular Surgery, Hospital do Servidor Público Estadual, São Paulo, Brazil, between March 2016 and July 2018. The patients were randomized into 2 groups and treated with oral anticoagulation for 6 months: either rivaroxaban (group 1) or warfarin (group 2). The study was registered at clinicaltrials.gov under NCT 02704598. RESULTS: Eighty-eight patients with deep venous thrombosis were admitted to the Vascular Surgery Department and randomized into the 2 groups. The follow-up time was 360 days. Analyses were performed at 180 and 360 days. Four patients were excluded from the study during follow-up because of a diagnosis of ovarian cancer (1 patient), head and neck cancer (1 patient), lung cancer (1 patient), and stomach cancer (1 patient). Therefore, 84 patients were evaluated: 46 patients in group 1 and 38 in group 2. The incidence of postthrombotic syndrome was 17.9% (15 cases) in the total cohort, but was significantly higher in group 2 (11 cases, 28.9%) than in group 1 (4 cases, 8.7%; P < .001; odds ratio, 4.278). The rate of total venous recanalization at 360 days was 40.5% (34 patients) in the total cohort, but was significantly higher in group 1 (35 patients, 76.1%) than in group 2 (5 patients, 13.2%; P < .001). The incidence of partial venous recanalization was 46.4% and was significantly higher in group 2 (28 patients, 73.7%) than in group 1 (11 patients, 23.9%; P = .016). Five patients in the total cohort (6%) showed no venous recanalization, all of them in group 2 (P = .016). CONCLUSION: In this study, patients who received oral rivaroxaban displayed a lower incidence of postthrombotic syndrome and a better total vein recanalization rate after 6 and 12 months than patients who received warfarin.

Impact of calcification and infrapopliteal outflow on the outcome of endovascular treatment of femoropopliteal occlusive disease.

OBJECTIVES: In this paper, we report the long-term outcomes of the endovascular treatment of femoropopliteal occlusive disease, focusing on the importance of calcification and runoff outflow on limb salvage and patency, and the factors associated with these outcomes at a single center. METHODS: This retrospective cohort study included consecutive patients with femoropopliteal occlusive who underwent femoropopliteal angioplasty at the Division of Vascular and Endovascular Surgery, Hospital do Servidor Público Estadual, São Paulo, Brazil, between January 2015 and July 2017. RESULTS: In total, 86 femoropopliteal occlusive angioplasties were performed in 86 patients, with an initial technical success rate of 95.34%. The mean ± standard deviation follow-up time was 880 ± 68.84 days. The analysis was performed at 720 days. Technical failure occurred in four patients, who were excluded from the analysis, leaving 82 patients and 82 femoropopliteal occlusive angioplasties. The estimated primary patency, secondary patency, limb salvage, and overall survival rates at 720 days were 60%, 96%, 90%, and 82.5%, respectively. In univariate and multivariate analyses, Cox regression showed worse primary patency rates in patients with one tibial vessel or isolated popliteal artery runoff (p = 0.005), calcification grade 4 (p = 0.019), calcification grade > 2 (p = 0.017), small vessel diameter < 4 mm (p = 0.03) or primary angioplasty without stenting (p = 0.021). A univariate analysis showed worse limb salvage in patients with one tibial vessel or isolated popliteal artery runoff (p = 0.039). CONCLUSIONS: In this study, the main factors associated with worse outcomes in the endovascular treatment of femoropopliteal occlusive in terms of loss of primary patency were one tibial vessel or isolated popliteal artery runoff, calcification grade 4, or calcification grade > 2, small vessel diameter < 4 mm, and no stents use. One tibial vessel or isolated popliteal artery runoff was also associated with limb loss in a univariate Cox regression analysis.