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Although there is not uniform definition of high-risk percutaneous coronary intervention (PCI), patients with severe three-vessel disease, left main disease, single remaining patent vessel and/or depressed left ventricular ejection fraction are considered a high-risk population. In this setting, periprocedural hemodynamic instability represents a serious issue. Percutaneous mechanical circulatory support (MCS) devices may improve both safety and efficacy of high-risk PCI. Indeed, MCS help to maintain coronary perfusion pressure and reduce myocardial workload, providing the operator sufficient time to reach the target of complete revascularization. The most used MCS are intra-aortic balloon pump and Impella. There are a plenty of data in literature about the efficacy and safety of the use of MCS in high-risk PCI performed through the femoral access. However, there is a paucity of data about the use of MCS in transradial high-risk PCI. Radial over femoral access has been showed to reduce bleeding complications and therefore may further improve the outcome of high-risk PCI. Herein we report a case of transradial high-risk PCI supported by the Impella 2.5 L and review the available data on this topic.

Objectives: One of the procedural concerns during percutaneous treatment of patients with concomitant coronary artery disease (CAD) and aortic valve stenosis (AS) is the risk of hemodynamic instability. In the present study, we assessed the safety and effectiveness of elective hemodynamic support with the Impella 2.5 system (Abiomed, Inc) in patients undergoing combined high-risk percutaneous coronary intervention (PCI) and balloon aortic valvuloplasty (BAV), as a bridge to transcatheter aortic valve replacement., Methods: Ten patients suffering from acute coronary syndrome (ACS) and severe AS were included. In all patients, we first performed PCI with the hemodynamic support of the Impella 2.5 system, and then BAV., Results: The Impella catheter was successfully positioned in the left ventricle in all instances. All cases were successful, without any intraprocedural complications. All patients were discharged without any major clinical events., Conclusions: These preliminary results suggest that elective use of the Impella 2.5 system is safe and effective when performing PCI and BAV in high-risk ACS patients suffering from concomitant severe CAD and AS.

Aims: We aimed to assess whether the RenalGuard™ System is effective in preventing acute kidney injury (AKI) following transcatheter aortic valve implantation (TAVI)., Methods and Results: Forty-eight consecutive patients with chronic kidney disease (CKD) scheduled for TAVI were assigned to: 1) hydration with sodium bicarbonate solution (Control group), or 2) hydration with RenalGuard Therapy (RenalGuard group). Hypotension was defined as periprocedural mean blood pressure <55 mmHg. The primary endpoint was the occurrence of AKI (i.e., an increase of ≥0.3 mg/dL in the serum creatinine concentration at seven days). AKI occurred in 10/26 (38.5%) patients in the Control group and in 1/22 (4.5%) patients in the RenalGuard group (p=0.005, odds ratio [OR] 0.076, 95% confidence interval [CI]: 0.009-0.66). RenalGuard Therapy protected against AKI (OR 0.71, 95% CI: 0.07-0.775, p=0.026), whereas post-procedural hypotension (OR 3.88, 95% CI: 1.06-14.24, p=0.040), and contrast media volume (OR 3.65, 95% CI: 1.15-5.75, p=0.043) increased the risk of AKI., Conclusions: This non-randomised pilot study suggests that RenalGuard Therapy may be effective in preventing AKI in CKD patients undergoing TAVI.

Objectives: This study sought to investigate acute kidney injury (AKI) following carotid artery stenting (CAS)., Background: Few data exist on AKI following CAS., Methods: This study evaluated 126 chronic kidney disease (CKD) patients who underwent CAS. The risk for contrast-induced AKI was defined by the Mehran score. Hemodynamic depression (i.e., periprocedural systolic blood pressure <90 mm Hg or heart rate <60 beats/min), AKI (i.e., an increase of ≥0.3 mg/dl in the serum creatinine concentration at 48 h), and 30-day major adverse events (including death, stroke, and acute myocardial infarction) were assessed., Results: AKI occurred in 26 patients (21%). Although baseline kidney function and contrast volume were similar in the AKI group and the non-AKI group, the risk score was higher (10 ± 3 vs. 8 ± 3; p = 0.032), and hemodynamic depression (mostly due to hypotension) (65.5% vs. 35%; p = 0.005) was more common in the AKI group. The threshold of hemodynamic depression duration for AKI development was 2.5 min (sensitivity 54%, specificity 82%). Independent predictors of AKI were hemodynamic depression (odds ratio [OR]: 4.01; 95% confidence interval [CI]: 1.07 to 15.03; p = 0.009), risk score (OR: 1.29; 95% CI: 1.03 to 1.60; p = 0.024), and male sex (OR: 6.07; 95% CI: 1.18 to 31.08; p = 0.021). Independent predictors of 30-day major adverse events that occurred more often in the AKI group (19.5% vs. 7%; p = 0.058) were AKI (HR: 4.83; 95% CI: 1.10 to 21.24; p = 0.037) and hemodynamic depression (HR: 5.58; 95% CI: 1.10 to 28.31; p = 0.038)., Conclusions: AKI in CKD patients undergoing CAS is mostly due to hemodynamic depression and is associated with a higher 30-day major adverse events rate., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to assess the safety and the efficacy of bivalirudin compared with unfractionated heparin (UFH) alone in the subset of patients at increased risk of bleeding undergoing transfemoral elective percutaneous coronary intervention (PCI)., Background: Bivalirudin, a synthetic direct thrombin inhibitor, determines a significant decrease of in-hospital bleeding following PCI., Methods: This is a single-center, investigator-initiated, randomized, double-blind, controlled trial. Consecutive biomarker-negative patients at increased bleeding risk undergoing PCI through the femoral approach were randomized to UFH (UFH group; n = 419) or bivalirudin (bivalirudin group; n = 418). The primary endpoint was the rate of in-hospital major bleeding., Results: The primary endpoint occurred in 11 patients (2.6%) in the UFH group versus 14 patients (3.3%) in the bivalirudin group (odds ratio: 0.78; 95% confidence interval: 0.35 to 1.72; p = 0.54). Distribution of access-site and non-access-site bleeding was 18% and 82% in the UFH group versus 50% and 50% in the bivalirudin group (p = 0.10)., Conclusions: The results of this randomized study, carried out at a single institution, suggest that there is no difference in major bleeding rate between bivalirudin and UFH in increased-risk patients undergoing transfemoral PCI. (Novel Approaches in Preventing and Limiting Events III Trial: Bivalirudin in High-Risk Bleeding Patients [NAPLES III]; NCT01465503)., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Purpose: Bivalirudin (Angiox, The Medicine's Company, Parsippany, NJ), a synthetic direct thrombin inhibitor, when compared with standard antithrombotic therapy (including unfractionated heparin [UFH] alone or plus a glycoprotein IIb/IIIa inhibitor) determines a significant decrease of major and minor bleeding and similar protection against ischemic events both in elective and in urgent percutaneous coronary intervention (PCI). There is a lack of prospective clinical trial assessing the safety and the efficacy of bivalirudin compared with UFH alone in the subset of biomarker negative patients at high risk of bleeding undergoing to elective PCI through the femoral approach., Methods: This is a single-center, investigator-driven, randomized, double-blind, controlled trial ( www.clinicaltrial.gov registration: NCT01465503). Consecutive patients at high bleeding risk (score ≥10 according to Nikolsky et al.) undergoing elective PCI through the femoral approach will be screened for eligibility. Included patients will be randomized (ratio 1.1) to bivalirudin (Bivalirudin group) and UFH (UFH group). The primary endpoint will be the rate of major bleeding (REPLACE 2 criteria). We expect a major bleeding rate ≥5 % in the UFH group versus a ≤3 % event rate in the Bivalirudin group. Aiming for a 0.05 alpha and 0.80 power, a total of 662 patients will be needed. This number will be increased by about 25 % (leading to a total of ≈830 patients) because of uncertainty about expected endpoint rates., Conclusions: The present trial will give important information on what is the best anticoagulation regimen when performing PCI through the femoral approach in patients at high risk for bleeding.

We describe the case of a 76-year-old male with a pseudoaneurysm of the left common carotid artery that developed 7 months following carotid endarterectomy (CEA) and was treated by stent graft implantation, which may represent a valid alternative to surgical repair for the treatment of post-CEA pseudoaneurysm.

In order to evaluate the incidence, the diagnostic modalities and significance of blisters of the abdominal aortic aneurysm wall, in a retrospective review, 14 patients (2.6%) having these lesions were identified between 1983 and 1995. At preoperative examination, aortography had less accuracy (1 case = 20%) than CT scan (3 cases = 27.2%) or MRI angiography (6 cases = 85.7%) to detect blisters; others were discovered intraoperatively in the remaining four patients. Most blisters were located on the anterior or antero-lateral wall of aneurysms; its area ranged from 0.8 to 2.6 cm2. One patient with a suspected blister diagnosed at aortography, during chest physiotherapy for his COPD, presented sudden abdominal pain: at urgent laparotomy, an acute contained rupture of a large blister, without extraluminal blood loss, was found. All patients underwent aneurysm repair, with no postoperative deaths. Occurrence of rupture in one patient clearly indicates the natural course of aortic blisters. MRI angiography may accurately detect these lesions; surgical treatment is necessary for preventing imminent rupture.

A variety of anatomical abnormalities may product an external compression of the popliteal artery, resulting in a thrombotic occlusion. Between 1983 and 1995, 9 patients presented a popliteal artery entrapment syndrome, bilateral in two cases. Ultrasonography, Angio-CT scan and MRI showed the abnormal structures and position of the popliteal artery on popliteal fossa. Arteriography detected an arterial compression in 6 limbs and occlusion in 4 limbs as well as an associated popliteal aneurysm in one patient and distal embolism in four. The abnormal medial head of the gastrocnemius muscle was resected in 8 limbs, while fibrous membranes were resected in 3 limbs. Autogenous vein replacement was performed in 4 cases of popliteal artery occlusion and following resection of a popliteal artery aneurysm in one case. All patients recovered. In the followup period, the occlusion of the arterial reconstruction occurred after 28 months in one patient, with a mild claudication. Noninvasive vascular imaging techniques may allow early diagnosis and management of PAES, avoiding popliteal arterial wall lesions and its occlusion, with a better outcome.

To evaluate the treatment of late sequelae of penetrating arterial injuries associated with civilian firearms, such as false aneurysms and arteriovenous fistulas (AV-Fs) of the extremities, a retrospective clinical study was carried out. Whenever diagnosis or operative management is delayed because of local fibrosis or morphological and structural vessel changes, primary repair is not feasible and segmental resection is required. Twenty-four patients presenting late false aneurysms (14) and AV-Fs (11) of the extremities, caused by firearms (6 rifle wounds, and 18 pistol wounds), were identified between 1983 and 1995. Twenty-three patients were submitted to resection of pseudoaneurysms (13) or AV-Fs (8), while arterial patch angioplasty was applied in two patients. The venous lesions were repaired by an interposition graft (7) or lateral venorraphy (3). Saphenous vein (15) or PTFE (6) grafts were placed in injured arteries. Percutaneous embolization by coils was performed in two patients. Twenty-three out of 24 patients (95.8%) recovered; one patient (4.1%), affected by aneurysmal AV-Fs of a lower limb dating from 12 years, with enlarged and weakened artery, bled to death. No limb loss occurred. A better evaluation of minimal vascular injuries is required to avoid late sequelae of civilian firearms lesions, with significant blood loss, which need segmental excision of the injured vessels.

Among complications of vascular access operations, symptomatic steal syndrome is uncommon, but may lead to ischemia of the hand. Between 1983 and 1995, 5 patients with hemodialysis fistulas presented rest pain of finger necrosis with a wrist-brachial index of 0.56 (range 0.35 to 0.63) improving to 0.96 (range 0.72 to 1.05) after digital pressure of the fistula. Ligation of distal radial artery was performed in 3 patients with side-to-end radiocephalic fistula, while basilic vein was distally ligated in a case of side-to-side brachiobasilic fistula. A vein "banding" procedure reduce fistula flow and improved distal perfusion in one patient, while a true venous aneurysm of the cephalic vein was treated by excision and replacement with a tapered PTFE graft. Hemodynamic assessment is required during surgical correction, but it may also be useful in pre- and intra-operative evaluation of patients undergoing therapeutical AVFs to prevent arterial insufficiency of the hand.

A unique case of true inferior pancreaticoduodenal artery aneurysm (IPDA) associated with occlusion of common hepatic artery is reported. Radiological and MRI findings are described. Because of high risk of visceral ischemia that contraindicated a percutaneous transluminal embolization, a successful tangential resection of aneurysm was performed.

This study was designed to compare the efficacy and safety of seaprose S and serratio-peptidase in the treatment of venous inflammatory disease. Forty patients entered the study (11 males, 29 females), mean age 54.3 years (range 30-77), mean weight 74.8 kg (range 51-96), with superficial thrombophlebitis. The trial was conducted following a controlled, between patients, randomized experimental design. Seaprose S was administered as 30 mg tablets at a daily dosage of 90 mg (one tab t.i.d.), and serratio-peptidase as 5 mg tablets, at a dose of 30 mg per day (two tabs t.i.d.), both orally, for 14 days. Twenty patients received seaprose S and 20 serratio-peptidase. The findings indicate that seaprose S was more effective and better tolerated than serratio-peptidase. Although the group of patients assigned to seaprose S had considerably more severe initial symptoms, by the end of treatment spontaneous pain was reduced 68.7% from the baseline mean score (from 3.2 to 1.0), as compared with a 63.3% reduction in the serratio-peptidase group (from 3.0 to 1.1). Pain on pressure was reduced 61.1% with seaprose S (from 3.6 to 1.4), compared to 57.6% with the reference treatment (from 3.3 to 1.4). Edema was reduced respectively 75% (from 1.6 to 0.4) and 56.2% (from 1.6 to 0.7); erythema diminished 72.4% (from 2.9 to 0.8) and 58.3% (from 2.4 to 1.0); nighttime cramps were 61.1% less (from 1.8 to 0.7) compared with 52.9% (from 1.7 to 0.8); hemorrhagic suffusion was 53.3% less (from 1.5 to 0.7) compared with 41.7% (from 1.2 to 0.7); cutaneous dystrophy was reduced by 11.1% (from 1.8 to 1.6) and 7.7% (from 1.3 to 1.2). At the end of the treatment with seaprose S efficacy was assessed as good or excellent in 85% of the cases, compared with 65% for serratio-peptidase. Seaprose S caused no adverse reactions. During serratio-peptidase treatment one patient reported diarrhea, requiring temporary dosage reduction and specific treatment. It can thus be confirmed that seaprose S was effective and well tolerated in patients with inflammatory venous diseases.

Objective: To evaluate diagnostic investigations, operative management and long-term outcome of atherosclerotic aneurysms of the subclavian artery., Design: A retrospective clinical study through a follow-up period of 68 months (8 months to 11 years)., Setting: Department of Vascular Surgery, University Hospital., Patients: Between 1983 and 1995, 5 patients with atherosclerotic aneurysms of the extrathoracic subclavian artery were reviewed. All patients presented a pulsatile supraclavicular mass. Ultrasonography and angiography confirmed the diagnosis and were useful in planning the operation., Interventions: Four patients were submitted, through a supraclavicular incision, to resection of the aneurysm and replacement of a prosthetic graft (dacron in 2 cases, PTFE in the remaining 2 cases). In one patient, with a small saccular aneurysm, a tangential aneurysmectomy with a patch angioplasty (PTFE) was performed., Results: All patients recovered after a mean hospital-stay of 9 days and had a valid radial pulsation. During the follow-up period, a dacron graft failure occurred 38 months later in one patient: she remains today asymptomatic., Conclusions: Resection is today recommended for all patients with diagnosed subclavian artery aneurysms. Because of unknown natural history of asymptomatic aneurysms, with an unpredictable risk of complications, more accurate evaluations are required for optimal clinical decision making (early surgery vs watchful waiting?).

With the introduction of the diagnosis-related groups system (DRGs), hospital cost containment without compromising quality of care is recommended. Carotid endarterectomy is an effective stroke prevention treatment; the need for routine postoperative intensive care unit (ICU) admission is questionable and is herein evaluated. Between January 1994 and November 1995, 68 patients underwent 79 carotid endarterectomies (CEAs), under general anesthesia, and were postoperatively monitored in a post-anesthesia care unit. 13 patients presented postoperative hypertension and 3 arrhythmia, while 5 patients (7.3%) experienced postoperative complications. Only 8 patients (11.7%) were admitted in ICU for treatment of persistent hypertension (3 cases) with continuous vasoactive drug infusion or because of postoperative complications. One patient (1.4%) died of post-CEA hyperperfusion syndrome. The use of a step down unit for monitoring patients undergoing CEAs is safe and cost-effective and also may identify patients requiring ICU admission.

In order to evaluate the results of the conservative follow up vs surgical management of infra-inguinal aneurysms, a retrospective review of 23 patients with 28 peripheral aneurysms of the lower limbs was undertaken. Among them, common femoral (5 cases) and popliteal (16 cases) aneurysms were most frequent; superficial femoral (1) and tibial (1) aneurysms were isolated; 5 patients had bilateral aneurysms. The majority of symptomatic aneurysms presented local discomfort (4), acute (4) or chronic (8) ischaemia. Symptoms of nerve (2) or view (1) compression were less common. Duplex or Color-Doppler Scanning, angio-TC and MR confirmed the clinical diagnosis; arteriography demonstrated the number of patent distal vessels. Nine arterial aneurysms were kept under clinical and ultrasonographic observation; three patients were submitted to delayed surgical repair; a major amputation was required and two of these died of cardiac diseases. In the remaining sixteen cases, early elective surgical repair was performed, with resection or ligation of aneurysms. Two cases of acute limb ischaemia were submitted to successful limb-salvage procedures. A primary amputation was necessary in a case with irreversible ischaemia; a lumbar sympathectomy was performed in a patient with a poor run-off. Dacron (5 cases), PTFE (5 cases) or autologous saphenous vein (11 cases) grafts were used. No post-operative complications or limb-loss occurred. Three patients died of myocardial infarction during the follow up period (mean 28 months). Authors' results suggest that early surgical repair of peripheral aneurysms of the lower limbs is the safest and most effective management.

External jugular vein aneurysms are rare and appear as a soft, compressible mass in the neck. Three cases are herein reported. Ultrasonography is the investigation of choice. Surgical excision is indicated, specially in case of giant and thrombosed venous aneurysm.

Between 1983 and 1995, elective aortic surgery was performed on 1018 patients for aneurysmal (417 cases) or occlusive disease (489 cases), or both (112 cases). Intraoperative acute popliteal occlusion, despite of aortic graft patency, developed in 2 patients due to distal embolization (0.19%) and in 5 patients secondary to acute popliteal trifurcation thrombosis (0.49%). Preoperative ankle index was 0.46 +/- 0.12, but intraoperatively it went down to zero; distal popliteal occlusion was confirmed by intraoperative arteriography. A balloon catheter embolectomy was performed in two patients. Distal bypass from popliteal artery above knee (1) and below knee (3) to the posterior tibial artery was implanted in four patients using reversed autogenous saphenous vein. In one patient, revascularization was not feasible because of diffuse calcified obstructive disease of leg arteries. Reoperations resulted in a satisfactory outcome in 6 out of 7 patients (85.7%). The patient, in which revascularization was not possible, was submitted to major amputation. In the four popliteal-to-tibial bypasses evaluated through a follow up period of 43 months, graft patency was 75% and limb salvage rate was 100%. Instead of amputation, popliteal-to-tibial bypass is a useful treatment for acute in situ thrombosis of popliteal trifurcation following aorto-iliac reconstruction.

Intestinal ischemia after abdominal aortic surgery is a highly lethal complication. In order to evaluate the pathogenesis, the diagnostic modalities and the best management, in a retrospective review, 12 patients undergoing postoperative small bowel or colonic ischemic lesions were identified between 1983 and 1995. Preoperative occlusion of IMA was present in nine patients, while a selective angiography of SMA demonstrated occlusive disease of peripheral branches in two asymptomatic diabetic patients. No patent IMA was ligated. When possible, hypogastric circulation was preserved by distal anastomosis into iliac bifurcation (4 cases). Postoperative leukocytosis or elevated LDH values were present. Colonscopy showed a suspected ischemic colitis in two patients and necrotic lesions in three cases. One patient died and diagnosis was made at autopsy. Nine patients were submitted to reoperation and a bowel resection with a proximal stoma was performed in seven of them. In two patients, the aorta or iliac artery below the proximal anastomosis and hypogastric artery suffered acute thrombosis, while prosthetic grafts were patent. A coagulation disorder caused thrombosis of intramural arterioles of the small bowel while peripheral branches of SMA were pulsatile. Eight of the patients submitted to relaparotomy died; non-operative management resulted in a left colon late stricture, while the remaining patient survived without sequelae. Overall mortality rate was 66.6%. Symptoms of this complication are not specific and diagnosis is delayed; consequently surgical repair is often unsuccessful. One patient with small bowel necrosis after elective AAA resection survived, which is extremely rare.

In this paper a new method of obtaining hemodynamic information from spectral analysis of continuous wave Doppler ultrasound signals is presented. Some considerations of the evaluation of maximum and mean frequencies of the signal arising from scattering in the insonated volume are proposed. A new algorithm to compute the maximum frequency has been applied. Maximum and mean frequency are, respectively, proportional to the maximum and mean velocity in the insonated volume. Their application to mathematical models enables an estimate of velocity profiles into the vessels. The proposed method offers the possibility of matching an accurate evaluation of spectral broadening. In vitro tests and some clinical results involving healthy young people, arteriopathic and stenotic patients show the potential of the method in evaluating different hemodynamic conditions.

During the last three years we have analyzed, in 94 patients with chronic arterial occlusive disease, in order to assess the hemorheological and hemocoagulative balance, the following parameters: prothrombin time, partial thromboplastin time, antithrombin III, antiplasmin, fibrinogen, factor VIII, erythrocyte sedimentation rate, platelet aggregation, erythrocyte filterability and hematocrit values. The main findings were: in 56 patients the hematocrit value was higher than 44%; Katz index was above normal values in 61.7% of the cases; ATIII showed a trend to lower values; platelet aggregation was increased; no significant variations in comparison to normal values were found in FVIII, antiplasmin levels, prothrombin time and partial thromboplastin time. Erythrocyte filterability values were decreased at a level as lower as more advanced was the clinical stage of the disease. These findings show, in agreement with those of other authors, the presence of hyperviscosity and hypercoagulative state in patients with chronic arterial occlusive disease.