Endovascular carotid revascularization under open-chest extracorporeal circulation combined with cardiac surgery in unstable patients at increased risk of carotid-related stroke: SIMultaneous urgent cardiac surgery and MicroNet-covered stent carotid revascularization in extreme-risk patients-SIMGUARD Study.

BACKGROUND: In patients at urgent need for cardiac surgery coexisting with increased-stroke-risk carotid stenosis, any staged intervention increases the risk of complications from the primarily unaddressed pathology. In this challenging cohort, we assessed safety and feasibility of endovascular carotid revascularization under open-chest extracorporeal circulation (ECC) combined with cardiac surgery (hybrid-room true simultaneous treatment). METHODS: Per-protocol (PP), after general anesthesia induction, chest-opening and ECC stand-by installation, carotid stenting (CAS) was performed (femoral/radial or direct carotid access) with ad-hoc/on-hand switch to ECC cardiac surgery. RESULTS: Over 78 months, 60 patients (70.7±6.9years, 85% male, all American Society of Anesthesiology grade IV) were enrolled. All were at increased carotid-related stroke risk (ipsilateral recent stroke/transient ischemick attack, asymptomatic cerebral infarct, increased-risk lesion morphology, bilateral severe stenosis). Majority of study procedures involved CAS+coronary bypass surgery or CAS+valve replacement±coronary bypass. 45 (75%) patients were PP- and 15 (25%) not-PP (NPP-) managed (context therapy). CAS was 100% neuroprotected (transient flow reversal-64.4%, filters-35.6%) and employed micronet-covered plaque-sequestrating stents with routine post-dilatation optimization/embedding. 4 deaths (6.7%) and 7 strokes (11.7%) occurred by 30-days. Despite CAS+surgery performed on aspirin and unfractionated heparin-only (delayed clopidogrel-loading), no thrombosis occurred in the stented arteries, and 30-days stent patency was 100%. NPP-management significantly increased the risk of death/ipsilateral stroke (OR 38.5; P<0.001) and death/any stroke (OR 12.3; P=0.002) by 30-days. CONCLUSIONS: In cardiac unstable patients at increased carotid-related stroke risk who require urgent cardiac surgery, simultaneous cardiac surgery and CAS with micronet-covered stent lesion sequestration is feasible and safe and shows efficacy in minimizing stroke risk. Larger-scale, multicentric evaluation is warranted. (SIMGUARD NCT04973579).

Combined intra-arterial and intra-muscular transfer of Wharton's jelly mesenchymal stem/stromal cells in no-option critical limb ischemia - CIRCULATE N-O CLI Pilot Study.

Introduction: Despite progress in pharmacologic and revascularization therapies, no-option critical limb ischemia poses a major clinical and societal problem. Prior cell-based strategies involved mainly autologous (limited) cell sources. Aim: To evaluate the safety and feasibility of a novel ischemic tissue reparation/regeneration strategy using Wharton's jelly mesenchymal stem/stromal cells (WJMSCs) as an "unlimited" cell source in N-O CLI (first-in-man study, FIM). Material and methods: Enrollment criteria included Rutherford-4 to Rutherford-6 in absence of anatomic/technical feasibility for revascularization and adequate inflow via the common femoral artery with patency of at least one below-the-knee artery. 30 × 106 WJMSCs were administered intra-arterially and intra-muscularly (50%/50%) over 3-6-week intervals (3-6 administrations). Safety, feasibility and potential signals of efficacy were assessed at 12 and 48 months. Results: Five patients (age 61-71, 60% male, Rutherford-6 20%, Rutherford-5 60%, Rutherford-4 20%) were enrolled. WJMSCs were administered per protocol in absence of administration technique-related adverse events. Hyperemia, lasting 12-24 h, occurred in 4/5 subjects. Transient edema and pain (reactive to paracetamol) occurred in 3 (60%) patients. Amputation-free survival was 80% after 12 and 48 months. In those who avoided amputation, ischemic ulcerations healed and Rutherford stage improved. 4/5 patients were free of resting pain after 3-6 doses. Conclusions: This FIM study demonstrated the safety and feasibility of WJMSCs use in patients with N-O CLI and suggested treatment efficacy with ≥ 3 doses. Our findings provide a basis for a randomized, double-blind clinical trial to assess the efficacy of WJMSC-based therapeutic strategy in N-O CLI patients.

Carotid artery stenting with Roadsaver stent. Early and four-year results from a single-center registry.

INTRODUCTION: Prevention of peri- and postprocedural complications is still a challenge in carotid artery stenting (CAS). AIM: To assess immediate and long-term safety and effectiveness of CAS using the Roadsaver double-nitinol-layer-micromesh stent. MATERIAL AND METHODS: Since 2014, 298 CAS procedures in 287 non-consecutive patients (203 men, mean age 70.5 ±8.6 years, 100% symptomatic/high risk lesions) have been performed using the Roadsaver stent and proximal (40%) or distal (60%) neuroprotection system. Clinical and neurological examinations as well as duplex ultrasound were completed before CAS, before discharge, at 1, 6 and 12 months, then annually. RESULTS: All CAS procedures were successful. Carotid stenosis was reduced from 84.9 ±9.9% to 11.0 ±9.4% (p < 000.1). In hospital, 1 ipsilateral periprocedural major (0.3%) and 3 minor (1.34%) ischemic strokes occurred, 2 (0.7%) patients died due to a cerebral hemorrhage on day 9 and 21. Three (1.0%) additional ipsilateral minor strokes within 30 consecutive days occurred. Thus, 30-day complications were observed in 9 (3.0%) patients. Two minor strokes were associated with in-stent thrombosis (0.7%). The 4-year follow-up showed 82% overall survival (95% CI: 69-91%) with no significant difference between asymptomatic (77%) and symptomatic patients (97%; p = 0.076). The stroke-free survival was 89% (95% CI: 77-95%), 84% asymptomatic vs. 98% symptomatic (p = 0.187). Seven (2.3%) patients developed > 50% in-stent restenosis. CONCLUSIONS: Carotid artery stenting using the Roadsaver stent for symptomatic patients and high risk lesions showed to be safe and effective, with a low complication rate and acceptable in-stent restenosis risk in 4-year follow-up.

Coexistence and management of abdominal aortic aneurysm and coronary artery disease.

BACKGROUND: Abdominal aortic aneurysm (AAA) and coronary atherosclerosis share common risk factors. In this study, a single-center management experience of patients with a coexistence of AAA and coronary artery disease (CAD) is presented. METHODS: 271 consecutive patients who underwent elective AAA repair were reviewed. Coronary imaging in 118 patients was considered suitable for exploration of AAA coexistence with CAD. RESULTS: Significant coronary stenosis (> 70%) were found in 65.3% of patients. History of cardiac revascularization was present in 26.3% of patients, myocardial infarction (MI) in 31.4%, and 39.8% had both. In a subgroup analysis, prior history of percutaneous coronary intervention (PCI) (OR = 6.9, 95% CI 2.6-18.2, p < 0.001) and patients' age (OR = 1.1, 95% CI 1.0-1.2, p = 0.007) were independent predictors of significant coronary stenosis. Only 52.0% (40/77) of patients with significant coronary stenosis underwent immediate coronary revascularization prior to aneurysm repair: PCI in 32 cases (4 drug-eluting stents and 27 bare metal stents), coronary artery bypass graft in 8 cases. Patients undergoing revascularization prior to surgery had longer mean time from coronary imaging to AAA repair (123.6 vs. 58.1 days, p < 0.001). Patients undergoing coronary artery evaluation prior to AAA repair had shorter median hospitalization (7 [2-70] vs. 7 [3-181] days, p = 0.007) and intensive care unit stay (1 [0-9] vs. 1 [0-70] days, p = 0.014) and also had a lower rate of major adverse cardiovascular events or multiple organ failure (0% vs. 3.9%, p = 0.035). A total of 11.0% of patients had coronary artery aneurysms. CONCLUSIONS: Patients with AAA might benefit from an early coronary artery evaluation strategy.

Mesh-covered (Roadsaver) stent as a new treatment modality for symptomatic or high-risk carotid stenosis.

INTRODUCTION: Prevention of periprocedural stroke has a crucial role in carotid artery stenting (CAS) procedures. AIM: To assess retrospectively 30-day safety and effectiveness of 41 procedures of internal and common carotid artery stenting using the Roadsaver double nitinol layer micromesh stent in 40 non-consecutive patients with symptomatic or high-risk carotid artery stenosis. MATERIAL AND METHODS: The patients were men (n = 31) and women (n = 9); mean age was 67.8 ±7.9 years. Femoral access was used in 39 cases, whereas radial access was used in 2. Proximal (n = 27) or distal (n = 14) embolic neuroprotection was used. RESULTS: The Roadsaver stents (nominal diameter 7, 8 or 9 mm, length 25 or 30 mm) were implanted successfully in all cases. One minor stroke occurred after common carotid artery intubation with a guiding catheter (before stent deployment) and one transient postprocedural ischemic attack (TIA) of the ipsilateral cerebral hemisphere was observed. Internal/common carotid artery stenosis severity was evaluated by duplex Doppler. Maximal peak systolic velocity (PSV) before CAS was in the range: 2.0-7.0 m/s, mean: 3.9 ±1.0 m/s, at 24-48 h after stenting mean PSV was 1.1 ±0.4 m/s (p < 0.05), and at 30 days 1.1 ±0.3 m/s (p < 0.05). Maximal end-diastolic velocity (EDV) was 0.85-3.5 m/s, mean 1.4 ±0.5 m/s, at 24-48 h after stenting mean EDV was 0.3 ±0.1 m/s (p < 0.05), and at 30 days 0.4 ±0.1 m/s (p < 0.05). No restenosis or thrombosis was observed. Angiographic stenosis decreased from 82.9 ±9.1% (range: 61-97%) to 19.3 ±7.3% (range: 0-34%) (p < 0.05). CONCLUSIONS: The CAS using the Roadsaver stent seems to be safe and effective. Further studies involving larger patient populations and longer follow-up are needed.

Novel PARADIGM in carotid revascularisation: Prospective evaluation of All-comer peRcutaneous cArotiD revascularisation in symptomatic and Increased-risk asymptomatic carotid artery stenosis using CGuard™ MicroNet-covered embolic prevention stent system.

AIMS: Our aim was to determine (1) periprocedural and 30-day clinical safety and efficacy of the CGuard MicroNet-covered embolic prevention carotid stent system (MN-EPS) in routine use for unselected carotid stenosis (CS) patients undergoing CAS, as well as (2) feasibility of MN-EPS post-dilatation optimisation to minimise residual stenosis after CAS. METHODS AND RESULTS: This was a non-industry-funded, prospective academic study in all-referrals-tracked symptomatic and asymptomatic CS. In asymptomatic lesions, intervention was mandated only in case of increased stroke risk CS features. There was independent neurologist evaluation before CAS, at 48 hours and 30 days. There was external source data verification, angiographic core lab, and statistical analysis. Over 11 months, 108 referrals were recommended by the NeuroVascular Team for revascularisation: 101 (51-86 years, 55 symptomatic, evolving stroke in nine) underwent 106 (100% MN-EPS use) neuroprotection device-assisted (46% proximal, 54% distal) CAS; CEA was performed in seven. MN-EPS device success was 99.1%. Angiographic diameter stenosis was reduced from 83±9% to 6.7±5% (p<0.001). No MN-EPS foreshortening/elongation occurred (30 mm long was 29.82±0.68 mm; 40 mm long was 39.89±0.59 mm). The periprocedural death/major stroke/MI rate was 0%. One event, with no change in NIHSS or modified Rankin Scale and no clinical sequel, was adjudicated by the clinical events committee as minor stroke (0.9%). By 30 days there were no new events (0%). CONCLUSIONS: These increased risk consecutive patient data (1) indicate safety and efficacy of routine MN-EPS use in achieving endovascular reconstruction across all-comer CS lesion subsets, and (2) are consistent with MN-EPS protection against cerebral events extending throughout the stent healing period.

Low prevalence of collateral cerebral circulation in the circle of Willis in patients with severe carotid artery stenosis and recent ischemic stroke.

INTRODUCTION: The circle of Willis is thought to play a key role in development of collateral flow in patients with internal carotid artery stenosis (ICAS). AIM: To assess flow in the circle of Willis in patients with recent ischemic stroke (IS). MATERIAL AND METHODS: The study included 371 patients, 102 symptomatic with severe ICAS and recent IS (within the last 3 months) (group I) and 269 asymptomatic with severe ICAS (group II). Flow in the middle (MCA), anterior (ACA) and posterior (PCA) cerebral arteries and pattern of the cross-flow through anterior (ACoA) and posterior (PCoA) communicating arteries were assessed with transcranial color-coded Doppler ultrasonography (TCCD). RESULTS: The ACoA or PCoA was less prevalent in group I than in group II (54% vs. 78%, p < 0.001 and 20% vs. 42%, p < 0.001, respectively), resulting in lower peak-systolic velocity (PSV) in the MCA in group I vs. group II (p = 0.015). Any collateral pathway was present in 67% of patients in group I, compared to 86% in group II (p < 0.001). Both PSV and end-diastolic (EDV) flow velocity in the ACA were lower in patients with recent IS, compared to asymptomatic subjects (71 ±24 cm/s vs. 86 ±34 cm/s, p < 0.001 and 32 ±12 cm/s vs. 37 ±17 cm/s, p = 0.038, respectively). Presence of ACoA or PCoA and higher PSV in the MCA and ACA were associated with significant risk reduction of IS (RR = 0.28 (95% CI = 0.16-0.49, p < 0.001), RR = 0.28 (95% CI = 0.15-0.52, p < 0.001), RR = 0.97 (95% CI = 0.96-0.99, p < 0.001), RR = 0.99 (95% CI = 0.98-0.99, p < 0.032), respectively). However, ROC curves failed to show reliable MCA or ACA PSV cut-offs for IS risk assessment. CONCLUSIONS: The ACoA and PCoA seem to play a key role in the evaluation of IS risk in subjects with severe ICAS.

Invasive treatment for carotid fibromuscular dysplasia.

INTRODUCTION: Fibromuscular dysplasia (FMD) is an infrequent non-inflamatory disease of unknown etiology that affects mainly medium-size arteries. The prevalence of FMD among patients scheduled for endovascular treatment of carotid artery stenosis is unknown. AIM: To evaluate the prevalence and treatment options of carotid FMD in patients scheduled for carotid artery stenting (CAS). MATERIAL AND METHODS: Between Jan 2001 and Dec 2013, 2012 CAS procedures were performed in 1809 patients (66.1% men; age 65.3 ±8.4 years, 49.2% symptomatic). In case of FMD suspicion in Doppler-duplex ultrasound (DUS), computed tomography angiography was performed for aortic arch and extracranial and intracranial artery imaging. For invasive treatment of FMD carotid stenosis, balloon angioplasty was considered first. If the result of balloon angioplasty was not satisfactory (> 30% residual stenosis, dissection), stent placement was scheduled. All patients underwent follow-up DUS and neurological examination 3, 6 and 12 months after angioplasty, then annually. RESULTS: There were 7 (0.4%) (4 symptomatic) cases of FMD. The FMD group was younger (47.9 ±7.5 years vs. 67.2 ±8.9 years, p = 0.0001), with higher prevalence of women (71.4% vs. 32.7%, p = 0.0422), a higher rate of dissected lesions (57.1% vs. 4.6%, p = 0.0002) and less severe stenosis (73.4% vs. 83.9%, p = 0.0070) as compared to the non-FMD group. In the non-FMD group the prevalence of coronary artery disease was higher (65.1% vs. 14.3% in FMD group, p = 0.009). All FMD patients underwent successful carotid artery angioplasty with the use of neuroprotection devices. In 4 cases angioplasty was supported by stent implantation. CONCLUSIONS: Fibromuscular dysplasia is rare among patients referred for CAS. In case of significant FMD carotid stenosis, it may be treated with balloon angioplasty (stent supported if necessary) with optimal immediate and long-term results.

Distal neuroprotection system as option for right subclavian artery ostial recanalization.

We present the case of a 49-year-old woman with neurological symptoms and severe atherosclerosis of aortic arch branches affecting subclavian and carotid arteries. Our patient has a history of transient ischemic attack and recurrent paresthesias of her right arm. We present a double access intervention using a distal embolic neuroprotection device during ostial right subclavian artery recanalization. We recommend that use of an embolic protection device in right subclavian artery ostial recanalization should be considered.

Clinical presentation of extraintestinal infections caused by non-typhoid Salmonella serotypes among patients at the University Hospital in Cracow during an 7-year period.

The most characteristic finding in non-typhoid salmonella (NTS) infection is acute food related outbreaks of gastroenteritis, which is usually benign and self-limiting. However, more serious extraintestinal findings, such as bacteraemia and focal infections localized to any organ may appear. The objective of this paper is to describe the most important characteristic of the extraintestinal infections due to NTS serotypes observed in University Hospital, in Cracow between January 2000 and December 2006. To do so, we reviewed the clinical presentations, risk groups, complications and outcomes of in-patients, in which extraintestinal non-typhoid Salmonella serotypes were isolated, applying a clinomicrobiological protocol. Out of 30 patients with either bacteraemias (n = 22) or focal salmonella infections (n = 8), 12 had malignancies, 17 had immune dysfunction state, 9 had gastrointestinal disorders and 8 had chronic heart, pulmonary or kidney disease. Four of these patients (13%) who had hematological malignancies (2), renal transplantation (1) and pulmonary disease (1) died. Regarding the clinical picture, primary bacteraemia and focal infections occurred with similar frequency (33.3% and 26.7%, respectively); the remaining were bacteraemias secondary to gastroenteritis. The incidence rate (mean 0.30/1000 hospital admission/year) increased steadily from 0.19/1000 to 0.32/1000 hospital admission during the study period. From 30 Salmonella isolates from extraintestinal samples collected, only four isolates were resistant to ampicillin, ciprofloxacin or trimethoprim-sulfamethoxazole. This finding indicate that multidrug resistance does not represent a serious problem among NTS serotypes collected from the our medical center as monitored over a period of 7 years. Given this presentation, clinicians need to have a high index of suspicion and to consider preemptive therapy, especially in elderly patients who are likely to develop severe immunosuppression following interventions.

[Insufficiency of arteriovenous fistulas in patients with end-stage renal failure--emergency surgical procedures]. / Niedroznosc przetok tetniczo-zylnych u chorych ze schylkowa niewydolnoscia nerek--dorazne interwencje chirurgiczne.

From 1.07.1994 to 30.06.2001 in the 2-nd Department of Surgery and Department of Nephrology Collegium Medicum Jagiellonian University, in 274 patients with terminal renal failure 341 vascular access for hemo-dialysis have been performed. Acute insufficiency in functioning arteriovenous fistulas occurred in 93 patients. In six of them, an attempt of thrombectomy was done. In 56 patients (group I) we carried out the new fistula on the same vascular level. In the remaining 31 cases (group II) we were forced to perform the procedure at a higher level. To compare late results in both groups of patients the method of Life Table Analysis was used. Cummulated index of patency (Pk) in the time interval 10-12 months in two groups was 0.67. In the time interval 49-54 month in group I, Pk dropped to 0.38, in group II was 0.57. The study we carried out indicates that creation of vascular access on arterialized vessels, being profitable in many aspects, does not provide such long efficient functioning as those created on the new, higher level.