A novel risk assessment tool for postoperative delirium in vascular surgery: The stress model (Siena posTopeRative dElirium in vaScular Surgery).

OBJECTIVE: Postoperative delirium (POD) is a common complication with a high health-related impact. The creation of a model (Siena posTopeRative dElirium in vaScular Surgery) to identify high-risk patients with consecutive prompt diagnosis and correct management. METHODS: This is an observational retrospective study to evaluate POD incidence in patients who underwent elective vascular surgery procedures between 2018 and 2020. POD was detected using CAM and defined as the onset of an acute confusional state, clinically manifesting as a disturbed state of consciousness, cognitive dysfunction, or alteration in perception and behavior. The total population was divided in the development and validation subsamples. Multivariable logistic regression analysis was performed, identifying variables related to the occurrence of POD. An additive score was created and the STRESS score was internally validated using the Validation subgroup. RESULTS: A total of 1067 patients were enrolled. POD occurred in 111 cases (10.4%). Multivariable logistic regression analysis for POD occurrence revealed as significant predictors: age>75 years, CKD, dyslipidaemia, psychiatric disease, CAD, hospitalization in the previous month, preoperative NLR >3.59, preoperative Hb < 12 g/dl, preoperative Barthel score <75, major amputation, CLTI revascularization, general anesthesia, and postoperative urinary catheter. These variables were used to create the STRESS score. The model was applied to both development and validation subgroups; AUC was respectively 0.7079 (p < .0001) and 0.7270 (p < .0001). CONCLUSION: The STRESS score has a good predictive potentiality for POD occurrence in elective vascular surgery procedures. However, implementation and external validation are needed to be correctly used in everyday clinical practice.

Association between apical periodontitis and secondary outcomes of atherosclerotic cardiovascular disease: A case-control study.

AIM: To evaluate the association between apical periodontitis (AP) and atherosclerotic cardiovascular disease (ASCDV). METHODOLOGY: A total of 65 periodontally and systemically healthy patients (age ≥ 40 years) were included in the study. Periapical status was assessed through dental examination and periapical radiographs; 33 subjects had AP (AP+), while 32 acted as control (AP-). Moreover, data regarding their periapical index (PAI) score and the Decayed, Missing, and Filled Teeth (DMFT) index were recorded. All subjects underwent echo-colour Doppler assessment of carotid intima-media thickness (CIMT), carotid plaques, degree of stenosis using the North American Symptomatic Carotid Surgery Trial (NASCET) method, maximum diameter of the abdominal aorta (maximum AA) and common iliac arteries (CIA) diameters. Furthermore, peripheral blood flow was also measured using the ankle-brachial index (ABI). Simple and multiple regression analyses were performed. RESULTS: Among AP+ patients, 57.58% disclosed at least one sign of subclinical carotid atherosclerosis. Multiple regression analysis identified AP as a significant risk indicator for carotid plaques [OR = 4.87 (1.27, 18.98; p = .021)] and marked carotid intima-media thickenings (OR = 14.58 [1.22, 176.15], p = .035). A significant association was established between AP and other cardiovascular (CV) variables (CIMT, NASCET, and maximum AA). On the contrary, a higher PAI score does not correlate to increased odds of carotid alterations, and the presence of AP did not prove any significant change in CIA and ABI. No significant correlation was established between DMFT and other variables. CONCLUSIONS: Results from the current study highlight that the presence of AP may be regarded as a risk indicator for ASCVD, with AP being associated with 5-fold increased odds of having carotid plaques and 15-fold increased odds of having marked carotid intima-media thickenings. Further studies should be conducted in order to verify whether AP treatment could be beneficial for ASCVD signs.

Penumbra Indigo Percutaneous Aspiration Thrombectomy System in the treatment of Aortic Endograft Iliac Limb Occlusion: Results from an Italian Multicentre Registry.

OBJECTIVE: This study aimed to evaluate the safety and effectiveness of the Penumbra Indigo percutaneous aspiration thrombectomy (PAT) system in the clinical presentation of iliac limb occlusion (ILO) after endovascular aortic repair (EVAR). METHODS: A retrospective, observational, multicentre study conducted in eight Italian vascular centres. Consecutive patients presenting with ILO after EVAR were eligible. To assess vessel revascularisation, Thrombo-aspiration In Peripheral Ischaemia (TIPI) classification (score 0-3) was used at presentation (t1), after PAT (t2), and after adjunctive procedures (t3). Successful revascularisation was considered TIPI 2-3 (near complete or complete). Primary intra-operative outcomes were technical success (TS) of Indigo PAT and combined TS of PAT associated with adjunctive procedures when needed. Primary follow up outcomes were safety and effectiveness at one, six, and 12 months. RESULTS: From September 2019 to December 2021, there were 48 ILO and 17 patients (35%) [median age 75 years, IQR 71, 83 years; male, 14 (82%); urgent, 8 (47%)] were treated and enrolled. The median time after primary EVAR was 24 months (IQR 0, 42 months). The median clot age from ILO diagnosis to PAT was three days (IQR 1, 12 days). Ten patients (59%) presented with limb threatening ischaemia. At t1, TIPI 0 and 1 was present in 13 (76%) and four (24%) cases, respectively. At t2, primary TS (TIPI 2-3) was achieved in 14 cases (82%) after Indigo PAT (p < .001). Fifteen patients (88%) required adjunctive procedures (14 re-linings, one surgical patch angioplasty). At t3, combined TS was achieved in 16 cases (94%). Intra-operative complication included one (6%) distal embolisation, treated successfully. The 30 day mortality was one case (6%) due to pneumonia. At one, six, and 12 months, clinical success was 100% without ILO recurrence. The median follow up was 23 months (IQR 11, 41 months): at 18 months, survival and freedom from re-intervention were 91 ± 8% and 90 ± 9%, respectively. CONCLUSION: This study reports for the first time the efficacy and safety of Penumbra Indigo PAT for ILO after EVAR, with promising technical and clinical success up to one year.

The Combination of Vacuum-Assisted Thromboaspiration and Covered Stent Graft for Acute Limb Ischemia due to Thromboembolic Complications of Popliteal Aneurysm.

BACKGROUND: We present a standardized protocol of endovascular revascularization for patients with acute limb ischemia due to popliteal artery aneurysm (PAA) thromboembolic complication, based on the combination of vacuum-assisted thromboaspiration to improve tibiopedal outflow and covered stent graft to exclude the PAA. METHODS: All patients with a diagnosis of PAA complicated by thromboembolic events undergoing total endovascular rescue were prospectively enrolled in a dedicated database from November 2018 to November 2021. To assess vessel patency, the TIPI (Thromboaspiration In Peripheral Ischemia) classification was used. The primary end point was the primary technical success (at least one tibial vessel with a TIPI flow of 2 or 3). The 30-day overall mortality and amputation rates were considered as secondary end points. Patients' overall survival, limb salvage, freedom from reocclusion and reinterventions were reported as secondary late outcomes using Kaplan-Meier method. RESULTS: Seventeen male patients were enrolled with a mean age of 75.7 ± 9 years. Rutherford grading score was IIa in 52.9% (9/17) and IIb in 47.1% (8/17). PAA mean diameter was 37.4 ± 11.2 mm. All patients had tibial arteries involvement, and in 9 cases (52.9%) there was also the occlusion of the PAA. Mechanical thrombectomy with Indigo/Penumbra thromboaspiration system was used in all patients. PAAs were excluded using one or more VIABAHN covered endografts (range 1-3 pieces). Technical success was achieved in 94.1%. Fasciotomy was performed in 1 case (5.9%). Mortality and amputation rates at 30-day follow-up were respectively 0% and 5.9%. Survival rates at 6, 12, and 24 months were respectively 94.1%, 86.3%, and 67.9%. Secondary patency was achieved in all cases (100%). Freedom from reintervention was 80.4%, 65.8%, and 54.8% at 6-, 12-, and 24-month follow-up. Limb salvage was 88.2% at 6-, 12-, and 24-month follow-up, respectively. CONCLUSIONS: Although preliminary, our experience of total endovascular rescue for complicated PAA with thromboembolic events highlighted promising rates of limb salvage at 30 days after intervention. The total endovascular approach seems able to maximize tibiopedal outflow offering an interesting strategy in limb salvage.

Long-term results of treatment of infrarenal aortic aneurysms with low-profile stent grafts in a multicenter registry.

OBJECTIVE: In recent years, manufacturers have developed new stent grafts with lower profiles to increase the endovascular aneurysm repair applicability. As reported by the current European Society for Vascular Surgery guidelines, long-term evaluation of such low-profile platforms is strongly recommended. This study aims to report outcomes beyond 5 years from a multicenter registry, including a real-world cohort of patients electively treated with low-profile stent grafts. METHODS: A retrospective data collection of patients who had undergone elective implantation of low-profile endograft ≤16 Fr. (Zenith LP, Ovation, Incraft) was performed in nine centers. The primary endpoint was a long-term primary clinical success. Secondary endpoints were survival rate, freedom from abdominal aortic aneurysm (AAA)-related death, freedom from type I to III endoleak, limb patency, and freedom from all reinterventions. The Kaplan-Meier curves were stratified for investigative devices. A multivariate analysis evaluated predictors of primary clinical success and reintervention rate. RESULTS: A total of 619 patients were enrolled (Ovation, n = 373; Incraft, n = 111; and Zenith LP, n = 135), with a mean follow-up of 56.8 ± 22.8 months. The overall primary and the secondary clinical success rate at 8 years was 72.1% and 93.8%, respectively. At 8 years, overall survival was 53.2%, freedom from AAA-related death was 94.4%, freedom from reintervention was 74%, freedom from type I/III endoleak was 86.9%, and limb patency was 90.4%. A significantly worse primary clinical success of the Zenith LP was recorded as dependent on more limb-related events. No differences between platforms were registered in the rate of AAA-related deaths, open conversion, sac enlargement, and type I/III endoleaks (P = .26). Multivariate analysis identified iliac tortuosity (hazard ratio, 2.053) and Zenith LP (hazard ratio, 3.818) as significant independent predictors of clinical failure and reintervention. CONCLUSIONS: Low-profile stent grafts have acceptable long-term outcomes. Overall survival and AAA-related death were in line with those reported for traditional devices. Long-term surveillance and reintervention, when necessary, remain crucial to guarantee durability.

The relation between neutrophil/lymphocyte and platelet/lymphocyte ratios with mortality and limb amputation after acute limb ischaemia.

OBJECTIVE: Acute limb ischaemia is still considered a significant event, with considerable early- and long-term amputation and mortality risk. Our study aims to investigate the predictive role of pre-operative neutrophil/lymphocyte and platelet/lymphocyte ratios in terms of mortality and amputation risk in patients with acute limb ischaemia. METHODS: Pre-operative blood samples of all patients admitted with acute limb ischaemia were used to calculate neutrophil/lymphocyte and platelet/lymphocyte ratios. Population was subdivided into quartiles by platelet/lymphocyte ratio and neutrophil/lymphocyte ratio values, and Kaplan-Meier life tables were obtained for overall survival and limb salvage. The optimal neutrophil/lymphocyte ratio and platelet/lymphocyte ratio cut-offs were obtained from receiver operating characteristic curves with all-cause mortality and all kinds of amputation. Stepwise multivariate analysis was performed in order to identify independent risk and protective factors for mortality and amputations. RESULTS: A total of 168 patients were included in the analysis. Receiver operating characteristic curves identified cut-off values for neutrophil/lymphocyte ratio and platelet/lymphocyte ratio: neutrophil/lymphocyte ratio ≥5.57 for mortality; neutrophil/lymphocyte ratio ≥6.66 and platelet/lymphocyte ratio ≥269.9 for all amputations. Kaplan-Meier analysis revealed that survival rate in group neutrophil/lymphocyte ratio <5.57 was 83.4%, 78.9%, 73.7%, and 59.8%, respectively, at 12, 24, 36, and 48 months; in neutrophil/lymphocyte ratio ≥5.57 group was 62.4%, 51.3%, 47.8, and 43.7%, respectively (p < 0.0001). Freedom from all amputations was significantly higher in case of neutrophil/lymphocyte ratio and platelet/lymphocyte ratio below the identified cut-off values (p < 0.0001). Neutrophil/lymphocyte ratio and platelet/lymphocyte ratio were found as independent risk factors. CONCLUSION: Neutrophil/lymphocyte ratio and platelet/lymphocyte ratio are reliable markers for stratification of mortality and limb amputations in patients with acute limb ischaemia. The inexpensive nature and ready availability of these biomarkers' values reinforced their usefulness in everyday clinical practice.

Safety and Efficacy of Vacuum Assisted Thrombo-Aspiration in Patients with Acute Lower Limb Ischaemia: The INDIAN Trial.

OBJECTIVE: The aim was to evaluate the short term safety and effectiveness of the Penumbra/Indigo aspiration thrombectomy Systems (Penumbra Inc.) in patients with acute lower limb ischaemia. (ALLI). Recently, endovascular vacuum assisted thrombectomy devices, similar to those used in the management of acute ischaemic stroke, have become available for peripheral arteries, but data are still scarce. METHODS: To assess vessel patency, a modified Thrombolysis in Myocardial Infarction (TIMI) classification, called TIPI (Thrombo-aspiration In Peripheral Ischaemia), is proposed. The TIPI flow is assessed at presentation, immediately after treatment with the study device, and after all adjuvant procedures. The primary outcome is the technical success of the thrombo-aspiration with the investigative system, defined as near complete or complete revascularisation TIPI 2 - 3. Safety and clinical success rate were collected at one month. RESULTS: One hundred and fifty patients were enrolled. The mean age was 72.4 years and 73.3% were male. Rutherford grade on enrolment was I in 16%, IIa in 40.7%, and IIb in 43.3% with a mean ankle brachial index of 0.19. Primary technical success (TIPI 2 - 3 flow) was achieved in 88.7% of patients. Adjunctive procedures included angioplasty/stenting of chronic atherosclerotic lesions (n = 39), thrombolysis (n = 31), covered stenting (n = 15), and supplementary Fogarty embolectomy (n = 6). After all interventions, assisted primary technical success was 95.3% (TIPI 2 - 3 in 143/150). No systemic bleeding complications or device related serious adverse events were reported. At one month follow up, one death, and one below the knee amputation were recorded. Primary patency was 92% (138/150), and the re-intervention rate was 7.33%, resulting in an assisted primary and secondary patency of 94% and 99.33%, respectively. CONCLUSION: Results from the INDIAN registry reveal that mechanical thrombectomy using the Indigo system is safe and effective for revascularisation of ALLI as a primary therapy.

Multiple cavernous malformation syndrome: a casual diagnosis during carotid revascularization procedure.

INTODUCTION: Familial cerebral cavernous malformations (FCCM) are a rare condition characterized by the multiple presences of cavernous malformations located in the central nervous system. CASE DESCRIPTION: We present a case of FCCM incidental diagnosis in a 71-year-old male patient who underwent carotid artery stenting for high-grade carotid artery disease and subsequent reintervention for severe stent restenosis, determining neurological deficit. FCCM diagnosis was made due to the presence of hundreds of cavernous malformations located both in supra- and sub-tentorial regions highlighted by magnetic resonance and confirmed by genetic test for the mutation of the gene KRIT1, inherited also by his son.

The Limitations of Social Behaviour Imposed by CoVid-19 Impacted the Perception and the Evolution of Peripheral Arterial Disease Negatively.

BACKGROUND: The novel acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic imposed a national lockdown at the beginning of 2020. People faced social distancing, being forced to stay at home. Peripheral arterial disease (PAD) typically influences life habits and psycho-social relationship. It is now questionable how PAD can be affected by changes in lifestyle imposed by the Sars-CoV-19 Pandemic. This study's main objective is to evaluate how the limitations of social behavior set by Sars-CoV-19 Pandemic impact the perception and evolution of the disease in a group of patients with a diagnosed PAD. METHODS: The changes in the in the perception and the evolution of the PAD were evaluated by comparing results of a modified VascuQol-6 quality of life (QoL) survey referring to the time frame defined "No-Sars-CoV-2 period" (from July to December 2019) with results referring to the time frame defined "Sars-CoV-2 period" (from January to June 2020). An overall score (range 4-60) was calculated, and a comparison between the two period studies was reported. Receiver Operating Characteristics (ROC) Curves evaluated a delta value for each patient with revascularization of lower limb peripheral arteries. Optimal cut-offs were chosen based on their specificity, sensitivity. RESULTS: One-hundred-two PAD patients gave their informed consent to take part in the study. A significant general worsening of patients PAD perception in the Sars-CoV-2 period was recorded for the following items: lower limbs health status perception; overall activity limitation; walking ability limitation; overall daily walking distance; lower limbs fatigue perception; concerns about PAD worsening; pain discomfort (P < 0.05). The pain intensity changed from 4.7 ± 2.9 in the No-Sars-CoV-2 period to 6.3 ± 2.9 in the Sars-CoV-2 period significantly (P < 0.0001), even though analgesic drug intake did not increase considerably in Sars-CoV-2 period (P = 0.15). The overall score was 20.3 ± 7.4 for the No-Sars-CoV-2 period and 27.4 ± 7.6 in the Sars-CoV-2 period (P = 0.0001). The ROC curve built to analyze the relation between Delta-score and the need for revascularization identifies a cut-off > 8.5 (Area Under the Curve 0.5436; CI 95% 0.4252 to 0.6620) with a sensitivity and specificity respectively of 52.6% (CI 95% 37.26-67.52%) and 65.6% (CI 95% 53.40-76.08%). CONCLUSIONS: Patients with PAD were significantly hit by all the restrictions and the social limitations imposed to reduce the Sars-CoV-19 virus diffusion. Our study confirms that the perception and the evolution of PAD were significantly affected during the "Sars-CoV-2 period".

Misdiagnosed Acute Limb Ischemia in Three Nonhospitalized Patients Recovering From a Nonsevere COVID-19 Infection.

The incidence of venous and arterial thromboembolic complications in COVID-19 patients is significant. The vast majority of COVID-19 patients spend their quarantine at home in a self-isolation condition. The occurrence of Acute limb ischemia (ALI) is a dangerous event that needs prompt diagnosis and management with time-dependent recanalization outcomes. We present a case series of three COVID-19 patients who suffered from ALI that occurred during home self-isolation, and that were diagnosed and treated with a significant time-delay due to COVID-19 social implications.

A Simple Rescue Maneuver to Retrieve Intravascular Foreign Body: The Triple Wire Twisting Technique.

INTRODUCTION: Device fracture causing intravascular foreign body (IFB) is a rare event during endovascular procedures, with potential catastrophic outcome if not promptly removed. We present two cases of retrieval of fractured devices during peripheral lower limb procedures using three guidewires tangled around the IFB. TECHNIQUES: Case 1 was a patient with critical limb ischemia. During balloon angioplasty of a high calcified peroneal artery, the balloon catheter Amphirion Deep 2.5/150 mm (Medtronic) fractured in two pieces, leaving a 20 cm distal part into the artery. Three 0.014" guides were advanced distally the IFB and twisted all together using a single torque-device. It was possible to pull back the long balloon fragment into the popliteal and to reline it inside a 5 French sheath. Case 2 was a patient with acute limb ischemia. During the mechanical thrombo-aspiration using the Indigo System (Penumbra inc.), the distal wire of the olive-shaped separator cracked in the posterior tibial artery. By crossing the IFB with three 0.014" wires and twisting them around it, this 15mm fragment was successfully recaptured. CONCLUSIONS: We named this procedure Triple Wire Twisting Technique and, in our experience, this technique is safe and effective to recapture IFB during complex peripheral procedures. This poorly known rescue technique is not complex and requires materials that are available in all cath-lab. We truly believe that physicians can take advantage of knowing it when facing with IFB in any vessel.

Mini-Skin Incision for Carotid Endarterectomy: Neurological Morbidity and Health-related Quality of Life.

BACKGROUND: Cranial and cervical nerve (CCN) injury is recognized as a possible complication after carotid endarterectomy (CEA), which may result in minor local neurologic deficiencies and significant discomfort for the patient. The aim of this study is to investigate the effect of a mini-skin incision (<5 cm) on the CCN injury after CEA in comparison to standard longitudinal incision of 12-15 cm in a high volume center, and to evaluate health-related quality of life (HRQOL) outcomes in those patients who had undergone both types of the skin incision. METHODS: From January 2013 to December 2019, 446 CEAs (47.3%) were performed through a standard neck incision of 12-15 cm (group A), while 496 (52.7%) were performed through a mini-skin incision (<5 cm) (group B). Sixty-two patients underwent standard neck incision on one side and mini-skin incision on the other side (subgroup B). The main outcome measures were stroke, death, CCN injuries, cervical hematoma rates, and reinterventions. The HRQOL was assessed at baseline and after 30 days using Medical Outcomes Study Short-Form 36 and 6 disease-specific modified Likert scales. RESULTS: The stroke and death rate at 30 days was 1.12% in group A and 1% in group B (P = 1). The incidence of CCN deficits was significantly lower in group B (5.1%) in comparison to group A (13.4%) (P < 0.001). The cervical hematoma was more common after standard incision (4.9% vs. 1.2%, P = 0.02). HRQOL at 1 month showed that the outcomes after mini-skin incision were significantly better for less difficulty with eating/swallowing and neck pain (P < 0.01). CONCLUSIONS: CEA through a small incision (<5 cm) may reduce CCN complications without additional perioperative neurologic risks. As validated by patients with bilateral disease who experienced both surgical techniques, mini-skin incision is also associated with better HRQOL at 1 month, particularly with regard to eating/swallowing and neck pain.

Management of abdominal aortic aneurysm in nonagenarians: A single-centre experience.

OBJECTIVE: In the last decades, life expectancy has increased worldwide considerably. Traditionally, very elderly patients have been considered too frail to undergo major vascular interventions. Considering that abdominal aortic aneurysm is an age-related disease, there is an increasing need of a correct management of the disease even in nonagenarians, but data are still scarce. The purpose of this single-centre study is to report early and mid-term outcomes of all-comer abdominal aortic aneurysm patients in their 10th decades of age. METHODS: A retrospective review of our prospectively maintained database identified a total of 33 patients aged ≥ 90 presenting with abdominal aortic aneurysm between 2014 and 2019. Elective and emergency repairs were both considered. Early technical success and mortality rate at 30 days were considered as primary outcomes. Mid-term clinical success was reported, and overall survival, freedom from aneurysm-related death, re-interventions and endoleaks were estimated with the Kaplan-Meier method, stratified for elective of emergency repair and type of treatment. RESULTS: The mean age was 91.7 (range 90-96), and 63.6% were male. Mean abdominal aortic aneurysm diameter was 67.4 ± 16.8 mm. Sixteen patients were admitted for rupture abdominal aortic aneurysm: three untreated, five underwent open and seven underwent endovascular aneurysm repair (EVAR), with an early mortality rate of 100, 100 and 42.8%, respectively. Eighteen (60%) patients were asymptomatic, and all underwent elective EVAR, with an early mortality rate of 0%. At one-month follow-up, clinical success was 84% in EVAR group. At a median follow-up of 22.4 ± 14.5 months, no abdominal aortic aneurysm-related death was registered. Freedom from all cause of mortality was 77.3, 59.4 and 40.7% at one, two and three years. Freedom from endoleaks was 95.4% at one month and 61.7% at one and three years. Freedom from reintervention was 85.8% at three years. CONCLUSION: Elective EVAR in nonagenarians is associated with acceptable early and mid-term outcomes. Age by itself should not be considered an exclusion criterion for treatment.

The use of a low-profile stent graft with a polymer ring sealing technology combined with bare renal stent (vent technique) in patients with juxtarenal aneurysm not eligible for open surgery and fenestrated endograft.

OBJECTIVE: In cases of juxtarenal abdominal aortic aneurysm (jAAA), endovascular aneurysm repair (EVAR) involves the use of custom-made fenestrated stent grafts, which usually need large-diameter access vessels, superior costs, and a certain time between graft planning and delivery. We report our preliminary experience using the bare renal stent technique (called vent) in combination with the ultralow-profile stent graft Ovation (Endologix, Irvine, Calif) to seal jAAAs in patients evaluated to be unfit for open surgery and not suitable for fenestrated endograft. METHODS: A single-center retrospective review of jAAAs treated by Ovation vent technique from January 2015 to December 2018 was conduced. The vent procedure consisted of a modified, off-label deployment of the sealing ring of the ultralow-profile Ovation stent graft close to renal orifices in combination with short bare-metal stents. The exclusion criterion was a diameter >31 mm at the level of the lowest renal artery. Early technical and clinical results, estimated midterm survival, renal artery patency, freedom from type IA endoleak, freedom from reintervention, and freedom from neck enlargement (>2 mm) were reported. RESULTS: Overall, 38 patients had jAAA and were considered unfit for open repair and not eligible for fenestrated EVAR. The proximal neck was <5 mm in all cases (mean, 3.3 ± 1.2 mm). Vent renal stents were implanted bilaterally in 16 patients. Primary technical success was 94.7% (36/38), with satisfactory cannulation of all renal arteries and sealing of the aneurysm in all but two cases because of type IA endoleaks that were treated immediately with success. Primary clinical success at 1 month was 100%. During a median follow-up period of 22.4 ± 3.6 months (range, 1-46 months), no abdominal aortic aneurysm-related deaths occurred, and no patient was lost to follow-up. The survival curve at 1 year and 2 years was, respectively, 96.4% and 91.6% (standard error, 0.57%). There were no cases of neck dilation or endograft migration. Freedom from reintervention at 12 months and 24 months was 100% and 89.5%, respectively (standard error, 0.7%); freedom from type IA endoleak was 100% and patency of the renal artery was 100% at 2 years. CONCLUSIONS: The described technique includes the use of a low-profile stent graft with a polymer ring sealing technology combined with bare renal stents that are not competing for the same room. This early experience shows that the vent technique is safe and feasible and increases the range of treatment of those patients with jAAA who are unfit for open repair and for fenestrated EVAR because of several anatomic constraints.

ZILVERPASS Study: ZILVER PTX Stent vs Bypass Surgery in Femoropopliteal Lesions.

Purpose: To report the 12-month results of a multicenter, prospective, randomized controlled trial to determine if the ZILVER PTX paclitaxel-eluting stent was noninferior in terms of safety and efficacy compared with surgical bypass. Materials and Methods: This is a study in symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions comparing endovascular ZILVER PTX stenting vs surgical bypass surgery using a prosthetic graft (ClinicalTrials.gov identifier NCT01952457). Between October 2013 and July 2017, 220 patients (mean age 68.6±10.5 years; 159 men) were enrolled and randomized to the ZILVER PTX treatment group (113, 51.4%) or the bypass treatment group (107, 48.6%). Most of the lesions were occlusions (208, 94.5%); the mean lesion length was 247.1±69.3 mm. The primary outcome measure was primary patency at 12 months, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex-derived peak systolic velocity ratio <2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass. Results: The estimated 12-month primary patency rate was 74.5% (95% CI 66.3% to 82.7%) for the ZILVER PTX group vs 72.5% (95% CI 63.7% to 81.3%) for the bypass arm (p=0.998). Freedom from TLR at 12 months was 80.9% (95% CI 73.3% to 88.5%) for the ZILVER PTX group vs 76.2% (95% CI 68.0% to 84.4%) for the bypass group (p=0.471). The 30-day complication rate was significantly lower in the ZILVER PTX group (4.4% vs 11.3%, p=0.004). Also, procedure time and hospital stay were significantly shorter in the ZILVER PTX group (p<0.001 for both). Conclusion: With noninferior patency results, a lower complication rate, and shorter procedures and hospital stays, paclitaxel-eluting stenting might become a recommended treatment for long TASC C and D femoropopliteal lesions.

One-year experience of a regional service model of teleconsultation for planning and treatment of complex thoracoabdominal aortic disease.

OBJECTIVE: The objective of this study was to report the methodology and 1-year experience of a regional service model of teleconsultation for planning and treatment of complex thoracoabdominal aortic disease (TAAD). METHODS: Complex TAADs without a feasible conventional surgical repair were prospectively evaluated by vascular surgeons of the same public health service (National Health System) located in a huge area of 22,994 km2 with 3.7 million inhabitants and 11 tertiary hospitals. Surgeons evaluated computed tomography scans and clinical details that were placed on a web platform (Google Drive; Google, Mountain View, Calif) and shared by all surgeons. Patients gave informed consent for the teleconsultation. The surgeon who submits a case discusses in detail his or her case and proposes a possible therapeutic strategy. The other surgeons suggest other solutions and options in terms of grafts, techniques, or access to be used. Computed tomography angiography, angiography, and clinical outcomes of cases are then presented at the following telemeetings, and a final agreement of the operative strategy is evaluated. Teleconsultation is performed using a web conference service (WebConference.com; Avaya Inc, Basking Ridge, NJ) every month. An inter-rater agreement statistic was calculated, and the κ value was interpreted according to Altman's criteria for computed tomography angiography measurements. RESULTS: The rate of participation was constant (mean number of surgeons, 11; range, 9-15). Twenty-four complex TAAD cases were discussed for planning and operation during the study period. The interobserver reliability recorded was moderate (κ = 0.41-0.60) to good (κ = 0.61-0.80) for measurements of proximal and distal sealing and very good (κ = 0.81-1) for detection of any target vessel angulation >60 degrees, significant calcification (circumferential), and thrombus presence (>50%). The concordance for planning and therapeutic strategy among all participants was complete in 16 cases. In one case, the consultation was decisive for creating an innovative therapeutic strategy; in the remaining seven cases, the strategy proposed by the patient's surgeon was changed completely after the discussion. Technical success was the same (100%) if concordance in planning was present initially or not. Overall 6-month mortality was 4%, 0% for those patients with initial concordance in planning vs 12% for those without initial concordance (P = .33). Surgery was always performed in a tertiary hospital by local surgeons, and in two cases (8%) external surgeons joined the local surgical team. CONCLUSIONS: Such a regional service of teleconsultation may be of value in standardizing the treatment and derived costs of complex TAADs in a huge region under the same health provider. The shared decision-making strategy may be of medical-legal value as well.

Midterm Results of Proximal Aneurysm Sealing With the Ovation Stent-Graft According to On- vs Off-Label Use.

PURPOSE: To compare the use of the Ovation stent-graft according to the ≥7-mm neck length specified by the original instructions for use (IFU) vs those treated off-label (OL) for necks <7 mm long. METHODS: A multicenter retrospective registry (TriVascular Ovation Italian Study) database of all patients who underwent endovascular aneurysm repair with the Ovation endograft at 13 centers in Italy was interrogated to identify patients with a minimum computed tomography (CT) follow-up of 24 months, retrieving records on 89 patients (mean age 76.4±2.4 years; 84 men) with a mean follow-up of 32 months (range 24-50). Standard CT scans (preoperative, 1-month postoperative, and latest follow-up) were reviewed by an independent core laboratory for morphological changes. For analysis, patients were stratified into 2 groups based on proximal neck length ≥7 mm (IFU group, n=57) or <7 mm (OL group, n=32). Outcome measures included freedom from type Ia endoleak, any device-related reintervention, migration, and neck enlargement (>2 mm). RESULTS: At 3 years, there was no aneurysm-related death, rupture, stent-graft migration, or neck enlargement. There were no differences in terms of freedom from type Ia endoleak (98.2% IFU vs 96.8% OL, p=0.6; hazard ratio [HR] 0.55, 95% CI 0.02 to 9.71 or freedom from any device-related reintervention (92.8% IFU vs 96.4% OL, p=0.4; HR 2.42, 95% CI 0.34 to 12.99). In the sealing zone, the mean change in diameters was -0.05±0.8 mm in the IFU group and -0.1±0.5 mm in the OL group. CONCLUSION: Use of the Ovation stent-graft in patients with neck length <7 mm achieved midterm outcomes similar to patients with ≥7-mm-long necks. These midterm data show that the use of the Ovation system for the treatment of infrarenal abdominal aortic aneurysm is not restricted by the conventional measurement of aortic neck length, affirming the recent Food and Drug Administration-approved changes to the IFU.

Restenosis after Coronary and Peripheral Intervention: Efficacy and Clinical Impact of Cilostazol.

Restenosis is one of the main complications in patients undergoing coronary or peripheral revascularization procedures and is the leading cause for their long-term failures. Cilostazol is the only pharmacotherapy that showed an adequate efficacy for preventing restenosis in randomized, controlled studies after coronary or peripheral revascularization procedures. The present review sums up the main clinical evidence supporting the use of cilostazol after revascularization interventions, focusing on all its benefits, warnings, and administration schedules.

Patient Discomfort during Carotid Artery Stenting: A Comparison Study between Iodixanol versus Iopamidol.

BACKGROUND: The aim of this study was to compare the adverse effects of iodixanol and iopamidol in terms of patient's discomfort in subjects undergoing carotid artery stenting (CAS). METHODS: We retrospectively analyzed data of all successful CAS procedures performed in our department during a 15-year period study. All patients judged to be collaborative were included. From December 2000 to December 2005, we adopted iopamidol as contrast media (CM), thereafter iodixanol. Any transient unpleasant sensation of bitter taste or warmth perceived by the patient after intra-arterial injection of CM was recorded. Injection-associated discomfort was assessed by visual analog scale (VAS) score. Comparison between the 2 CMs with regard to the overall discomfort was carried out by using the Mann-Whitney test. Spearman correlation was performed to assess the correlation among discomfort, age, and CM used. A univariate analysis was performed for slightly bitter taste and warmth sensation to compare these clinical outcomes and CM used; subsequently, a logistic multivariate analysis regression was performed with the "backward elimination." RESULTS: Data from 1,633 patients were evaluated. A total of 608 patients underwent CAS procedure using iopamidol, and 1,025 using iodixanol. The total amount of CM used during a single procedure was 85 ± 17 mL/patient (range 60-135). The median VAS value was statistically significantly lower in the iodixanol group than in the iopamidol group (P < 0.001). A significant Spearman correlation coefficient was found between age and discomfort for both CMs used (Spearman rho 0.18 for iodixanol, 0.17 for iopamidol). The univariate analysis showed that patients undergoing CAS with iopamidol had an odds ratio (OR) of 8.48 (P < 0.001) to perceive warmth sensation. When adjusted for age and gender, the multivariate analysis still showed an OR of 8.03. For slightly bitter taste sensation, the crude analysis showed an OR of 1.31 (P = 0.018); adjusting for age and gender, OR became 1.15 and the difference was not statistically significant (P = 0.257). CONCLUSIONS: During CAS, less overall discomfort was reported in patients receiving iodixanol than iopamidol; in terms of warmth sensation, patients undergoing procedure using iopamidol as CM have a higher risk to perceive this clinical symptom than iodixanol. Slightly bitter taste seems to have a statistically significant relation with age and gender, and not with CM used.