Clinical significance of perioperative changes in ankle-brachial index with regard to extremity-related outcome in non-diabetic patients with critical limb ischemia.

PURPOSE: To evaluate the significance of perioperative changes in ankle-brachial index (ABI) with regard to extremity-related outcome in non-diabetic patients with critical limb ischemia (CLI) following revascularization. METHODS: The study represents a subanalysis of the multicentric Registry of First-line Treatment in Patients with CLI (CRITISCH). After exclusion of diabetic patients, conservative cases, and primary major amputation, 563 of 1200 CRITISCH patients (mean age 74 ± 10.7 years) were analyzed. This population was divided into two groups regarding perioperative ABI changes ∆ + 0.15 (Group 1) or ∆ - 0.15 (Group 2). Study endpoints were reintervention and major amputation during a mean follow-up of 14.6 ± 9 months. Logistic regression was performed in order to identify factors for ABI group affiliation. RESULTS: There were 279 patients in Group 1 (49.5%) and 284 in Group 2 (51.5%). ABI sensitivity and specificity regarding vessel patency were calculated to be 54 and 87%. A preoperative ABI ≤ 0.4 [odds ratio (OR) 7.7], patent vessels at discharge (OR 12.2), and secondary interventions (OR 2.4) were identified as factors for Group 1 affiliation. Contrariwise, previous revascularization (OR 0.6), a glomerular filtration rate ≤ 15 ml/min/1.73 m2 (OR 0.3), and TASC A lesions (OR 0.2) were associated with Group 2 affiliation. No statistical difference was found with regard to the need of reintervention. However, time to reintervention was significantly shorter in Group 2 compared to that in Group 1 (10.0 ± 9.5 months vs 12.1 ± 9.1 months; p = 0.005). Amputation rate in Group 2 was 14.4%, significantly higher compared to that in Group 1 (6.0%; p < 0.0001). CONCLUSIONS: Failure of perioperative ABI improvement is associated with a higher probability for amputation and should be valued as prognostic factor in non-diabetic patients with CLI. Patients with no/marginal improvement in ABI after revascularization require close follow-up monitoring and may benefit from early reintervention.

Streptococcus mitis and Gemella haemolysans were simultaneously found in atherosclerotic and oral plaques of elderly without periodontitis-a pilot study.

OBJECTIVES: Local infections may contribute to the initiation and progression of several clinical diseases in humans. Atherosclerotic plaques of subjects suffering from periodontitis are colonized by periopathogens; however, the presence of bacteria in atherosclerotic plaques in patients without severe forms of periodontitis is of high relevance for the general population. MATERIALS AND METHODS: Patients who were electively treated for atherosclerotic lesions of the carotid artery and without clinical signs of periodontitis were eligible for the study. Oral and atherosclerotic plaques were sampled, processed, and analyzed for their microbial composition by 454-sequencing. RESULTS: Seventeen patients were included in the analyses, and 76 % of all atherosclerotic plaque specimens were positive for bacterial DNA. In the oral plaques, 76,532 sequences were identified representing 1 phylum, 17 classes, 112 families, and 263 genera. In atherosclerotic plaques, 6112 sequences representing 1 phylum, 4 classes, 8 families, and 36 genera were found. The bacterial DNAs of the species Gemella haemolysans and Streptococcus mitis were simultaneously found in atherosclerotic as well as oral plaque samples of 3 patients. CONCLUSIONS: These results indicated that in subjects without periodontitis, the transmission of oral bacteria to atherosclerotic plaques of the carotid artery is a feasible event. CLINICAL RELEVANCE: The prevention of transient bacteremia from the oral cavity requires high levels of oral health.

Results of peripheral bypass surgery in patients with critical limb ischemia (CRITISCH registry).

AIM: On the basis of the CRITISCH registry outcomes in patients with critical limb ischemia (CLI) undergoing lower extremity bypass surgery were analyzed according to the site of distal anastomosis and type of bypass material. PATIENTS AND METHODS: A total of 284 patients with lower extremity bypasses consisting of 75 patients with bypasses above the knee (group 1), 80 with bypasses below the knee (group 2) and 129 crural or pedal bypasses (group 3) were included in the study. Altogether, 159 autologous saphenous vein grafts and 125 synthetic grafts were used. RESULTS: There were no perioperative complications in 191 out of the 284 patients (67.3 %) and 236 of the 284 patients (83.1 %) had open bypasses at hospital discharge. An uneventful postoperative course was observed in 76 % of the patients in group 1, 62.5 % in group 2 and 65.1 % in group 3. Amputation-free survival was 86 % at 1 year in group 1, 65 % in group 2 and 69 % in group 3. For bypasses above the knee synthetic grafts were at least not inferior to vein grafts (amputation-free survival at 1 year: prosthetic bypasses 92 % and saphenous vein grafts 71 %, p = 0.147), whereas in the crural/pedal bypass group vein grafts showed better amputation-free survival at 1 year (76 %) compared with synthetic bypasses (56 %, p = 0.105). Patients with a PREVENT III (PIII) CLI risk score ≤3 exhibited better amputation-free survival at 1 year (78 %) compared to patients with a PIII CLI risk score of 4-7 (69 %, p = 0.053). The same applied to patients with Rutherford class 4 vs. Rutherford class 6 CLI. CONCLUSION: In patients with CLI and above-knee bypasses, vein grafts confer no benefits compared with synthetic grafts for at least 1 year follow-up; however, in the case of more distal anastomoses vein grafts should be preferred.

Tortuosity is the Significant Predictive Factor for Renal Branch Occlusion after Branched Endovascular Aortic Aneurysm Repair.

OBJECTIVE: After multi-branched endovascular aneurysm repair (mbEVAR), renal branch occlusion is the most frequent form of branch failure. Pre-operative renal angulation and post-operative morphology of the renal branch were quantified and their impact on occlusion was analyzed. METHODS: Patients who underwent mbEVAR between January 2010 and December 2013 were reviewed retrospectively. Only renal branches constructed with caudally directed cuffs were included. Patients without post-operative computed (CT) angiography were excluded. The main outcome was the primary patency of the renal branches. The renal angulation and the morphology of renal branch (bridging length, renal coverage length, tortuosity index, and angulation of distal renal artery) were quantified using CT. The impacts of morphology, implanted stents, and patient characteristics were investigated by time to event analyses. RESULTS: Ninety renal arteries in 49 patients were enrolled. Median follow up was 12 months (IQR 6-20 months). Balloon expandable stent grafts were used in 93% (84/90) of renal branches. Self expandable stent grafts were used in 12. Ninety-one percent (82/90) were lined with self expandable bare stents. Ten branches occluded after 8 months (median; IQR 1-14 months). Four of them underwent re-interventions, achieving secondary patency. The median renal angulation was -10° (IQR -40 to 0). The median bridging length was 42 mm (IQR 39-46 mm) and renal coverage 17 mm (IQR 12-22 mm). Median tortuosity index was 1.11 (IQR 1.04-1.19). The angulation of the distal renal artery was 140.7 ± 20.5°. In multivariate analysis, a tortuosity index > 1.11 was identified as the only significant predictor for occlusion (hazard ratio: 4.94; 95% CI: 1.01-24.30, p = .04). CONCLUSIONS: High tortuosity was a significant predictor for the occlusion of renal branches, but renal angulation, bridging length, and the extent of renal coverage were not. By avoiding highly tortuous renal branch paths, good outcomes are expected even in upwardly directed renal arteries. Longer paths are acceptable.

Significant CT-angiographic evidence of coexisting abdominal aortoiliac aneurysms with simple renal cysts and abdominal wall hernias.

AIM: Aim of the study was to determine and compare the incidence of simple renal cysts (SRCs) and abdominal/inguinal wall hernias (AWHs/IHs) in patients with known abdominal aortoiliac aneurysm (AAA) and aortoiliac occlusive disease (AOD) in order to assess if these comorbidities could be promoted as added high risk factors for AAA development. METHODS: Prospectively collected clinical and radiological data of 236 AAA patients, treated at our institution between June 2009 and June 2012, were retrospectively analyzed regarding the number, location and type of SRCs and AWHs. Two hundred thirty-six randomly chosen patients with aortoiliac occlusive disease (AOD) were recruited as control group. RESULTS: SRCs and AWHs were significantly more frequent in the AAA group than in AOD group (68.6% vs. 37.3%, OR=2.110, 95%-CI 1.325-3.359, P=0.002 and 45.3% vs. 24.2%, OR=1.850, 95%-CI 1.153-2.968, P=0.011). In 30.1% of AAA patients both clinical entities were simultaneously detected (OR=2.441, 95%-CI 1.342-4.437, P=0.003), the comorbidity of SRCs and IHs was related to a 3.6-fold increased risk for a coexisting AAA (OR=3.558, 95%-CI 1.622-7.805, P=0.002). CONCLUSION: The findings of this study contribute to the clinical evidence of a significant coexistence of SRCs and AWH/IHs in AAA patients. However, further clinical screening trials and research are necessary to establish the clinical significance of this observation and to assess a possible common pathogenesis of systemic extracellular matrix degeneration in affected individuals.

Performance of Bridging Stent Grafts in Fenestrated and Branched Aortic Endografting.

OBJECTIVE/BACKGROUND: Bridging stent grafts (BSGs) are used to connect the target vessel with the main body during fenestrated or branched aortic endografting (f/bEVAR). No dedicated devices are available for BSG. The aims of this study were to assess the performance of BSGs. METHODS: Between January 2004 and May 2014 the data of patients treated with f/bEVAR were prospectively collected. Only patients treated after January 2010 were included. The main measurement outcome was any BSG related complications. A logistic regression analysis, including target vessel type, type of joint (fenestration or cuff), and type of BSG identified potential risk factors. RESULTS: One hundred and fifty consecutive patients underwent f/bEVAR, and 523 target vessels were involved. These included 104 celiac, 140 superior mesenteric, 275 renal, and four other arteries. The technical success rate was 99% (520/523 target vessels). Balloon expandable BSGs were mainly used (n = 494; 95%), and in 336 (65%) relining stents were combined. The primary reasons for technical failure were the dislocation of the main body (n = 1) and unsuccessful cannulation (n = 2). One was revascularized by means of the periscope technique. Four target vessel injuries were recorded and four renal arteries occluded peri-operatively. After a median follow up of 14 months (interquartile range 5.5-23.0), 13 (2%) BSGs occluded and 19 (4%) required re-interventions. Two SMA occlusions occurred, leading to death in both patients. The patency and freedom from re-intervention rates at 3 years amounted to 85% and 91%, respectively. Use of a branched main body was the only independent risk factor for re-intervention and for the composite event (hazard ratio [HR] 3.5, 95% confidence interval [CI] 1.3-9.9 [p = .02]; and HR 2.8, 95% CI 1.2-7.0 [p < .01], respectively). Of note, the use of relining stents seemed not to prevent BSG related complications. CONCLUSION: The currently used BSGs had low occlusion and re-intervention rates. Modifications of the branched design or dedicated BSG devices may improve outcome, especially after bEVAR.

[Cost and cost-effectiveness in the treatment of peripheral arterial occlusion disease - what is proven?]. / Kosten und Kosteneffizienz bei der Behandlung der peripheren arteriellen Verschlusskrankheit - was ist gesichert?

BACKGROUND: This overview comments on the health-care relevance of peripheral arterial occlusive disease (PAOD) in patients with intermittent claudication (IC) and critical limb ischaemia (CLI). We evaluated different treatment modalities in terms of cost-effectiveness. METHOD: For the literature review, the Medline database (PubMed) was searched under the key words "critical limb ischemia AND cost", "critical limb ischemia AND economy", "peripheral arterial disease AND cost", "peripheral arterial disease AND economy". RESULTS: In the years 2005 to 2009, the hospitalisations of patients with PAOD rose disproportionately in Germany by 20 %, to 483,961 hospital admissions. By comparison, hospital admissions altogether increased by only 8 %. The average in-patient costs were estimated to be approximately € 5000 per PAOD-patient - a rather conservative estimate. For the patient with IC the economic data position is clear, supervised exercise training is by far the most cost-effective treatment option, followed by percutaneous transluminal angioplasty (PTA) and finally the peripheral bypass. In accordance with the guidelines of the UK, the latter is therefore indicated only if PTA fails or is technically not possible. In patients with CLI, the situation is not obvious. Indeed, a short-term economic advantage can be calculated for the PTA, the long-term comparison of both methods, however, is impossible due to insufficient data. In addition, the risk factors for the patient have to be included in the calculation. This was indeed demonstrated in the short-term, but could not be analysed in the long-term follow-up. CONCLUSION: The issue of greater cost-effectiveness of open or endovascular treatment in patients with CLI is uncertain, the studies and patient populations are too heterogeneous. Further studies are urgently needed to structure the sequence of the various treatment options in guidelines and clinical pathways.

Early experience with the EntrustTM delivery system for stent treatment of the lower extremities' arteries via transbrachial approach.

AIM: The femoral artery remains the access of choice in the majority of peripheral vascular interventions. However, specific conditions indicate catheterization of the brachial artery. Contrary to balloon catheters, the majority of stent delivery systems are too short to facilitate transbrachial implantation of self-expandable stents (SES) in the superficial femoral artery (SFA). We report our experience with a new 150 cm working length SES-delivery system for transbrachial lower extremity interventions. METHODS: All patients treated with the Entrust(TM) delivery system (EDS) for lower extremity peripheral arterial disease (PAD) via a transbrachial access between December 2012 and February 2014 were included into this study. All data were prospectively collected and analyzed. Primary endpoints were the feasibility and safety of the EDS in the transbrachial setting. Secondary endpoints consisted of stent length accuracy after deployment, early clinical outcome and perioperative complications. RESULTS: Thirty-seven EverFlex(TM) stents with Entrust(TM) delivery system were implanted transbrachially in twenty-eight (N.=28) patients. The transbrachial implantation of a SES using the EDS was feasible in all patients. Stent compression or elongation >10%, premature jumping or movements of the implanted stents were not observed in any patient. Although no stent fractures were observed, a single stent occlusion was noticed. Early clinical success was achieved in all but one patient, with one patient requiring a surgical revision of the puncture site due to pseudoaneurysm. CONCLUSION: The early experience with the new SES-delivery system suggests that EDS enables the safe and effective treatment of the lower extremities PAD via a transbrachial approach. However, further evaluation is needed to define whether the use of the new long shaft stent delivery system influences the performance of the EverFlex(TM) stent in the long run.

Long-term outcome of femoropopliteal stenting. Results of a prospective study.

AIM: Aim of the study was to assess the long-term clinical results of primary stent placement in patients with femoro-popliteal lesions and intermittent claudication (IC) or critical limb ischemia (CLI). METHODS: Prospectively collected data of 517 patients (543 limbs) treated for IC (N.=422; 77.5%) and CLI (N.=121; 22.5%), between September 2006 and December 2010 were evaluated. Survival, limb salvage and patency rates were analyzed and multivariate analysis was performed to evaluate possible risk factors for the development of restenosis. RESULTS: Mean patients' age was 70.6 years (SD ±10); 64.8% of the patients (N.=335) were male. Angiography revealed TASC A or B lesions in 64.5% (N.=350), TASC C or D lesions in 35.5% (N.=193) of the patients. Two hundred thirty-two patients had evidence of occluded femoropopliteal artery (42.7%) and the remaining patients had evidence of high grade (>70%) stenosis. In total, 827 bare metal nitinol stents (1.53±0.9 per limb) were used. No early (<30-day) procedure-related death was recorded. After a mean follow-up period of 60 months (SD ±13.5), 69 patients died (13.4%). Eight (1.5%) patients underwent major amputation. The amputation rate was significantly higher in the CLI group compared to the IC group (P=0.03). Primary patency rates were 86.2%, 79.1%, 75.1% and 62.2% after 1, 2, 3 and 5 years, respectively. No difference in terms of patency rates was found between the results of the treatment of TASC A/B versus TASC C/D lesions and the patient groups with IC versus CLI. CONCLUSION: The endovascular-first line treatment with use of nitinol stents for patients with femoropopliteal artery lesions is associated with acceptable long-term patency rates, even in patients with long lesions.

New EVAR devices: pros and cons.

The first randomized controlled trials comparing the two procedures (EVAR versus open repair) for the treatment of abdominal aortic aneurysms showed considerably better short-term outcomes and on the other side higher rates of device-associated reinterventions and remarkable financial burden in the endovascular arm. In the meantime, specialists experience and expertise have been improved significantly. To solve the reported drawbacks and to prevent endografts-associated complications, safer fixation features, lower profile, more flexible design and new revolutionary release and deployment mechanisms of stent-grafts have been also developed and established over the last years. In this review, we present the new EVAR devices and attempt to provide an overview of their premature performance based on the literature and the clinical practice in our institution.

The impact of gender on in-hospital outcomes after carotid endarterectomy or stenting.

AIM: We sought to better define the impact of sex on 'in-hospital outcomes' after carotid endarterectomy (CEA) or stenting (CAS). METHODS: Hospital discharge databases for all carotid interventions obtained from the New York State (NYS) Department of Health, Statewide Planning and Research Cooperative System between 2000 and 2009 (29,917 women, 39,771 men) were analysed. Mortality, stroke and composite event (stroke/death) were compared between procedures after matching of patients by propensity score. Acute myocardial infarction (AMI) was our secondary 'end' point. RESULTS: More than 90% of patients in both sexes were asymptomatic (27,439 women and 36,295 men). Compared to men, asymptomatic women experienced more strokes after CEA (women: 1.38%, men: 1.16%, P = 0.03) and higher AMI rates after both procedures (CEA; women: 0.75%, men: 0.51%, P = 0.0009, CAS; women: 0.96%, men: 0.28%, P = 0.01). Between procedures, symptomatic women undergoing CAS showed higher rates of mortality (CAS: 4.19%, CEA: 0.47%, P = 0.01) and combined (stroke/mortality) events (CAS: 12.09%, CEA: 6.05%, P = 0.02). In all other cohorts, no statistically significant difference was found between the procedures. CONCLUSIONS: Compared to CEA, CAS led to inferior in-hospital outcomes only in symptomatic women in the last decade in NYS. Men and asymptomatic women showed comparable outcomes after both procedures, whereas asymptomatic females were more prone to AMI after both interventions. These sex-associated differences should be taken into account for the treatment of carotid artery disease.

Prevention of vascular graft infections with antibiotic graft impregnation prior to implantation: in vitro comparison between daptomycin, rifampin and nebacetin.

OBJECTIVE: To compare the in vitro efficacy of graft impregnation with nebacetin versus rifampin versus daptomycin against vascular graft infections caused by Staphylococcus epidermidis and Staphylococcus aureus and nebacetin versus rifampin against Pseudomonas aeruginosa and Escherichia coli. MATERIALS: Twenty-three Dacron-grafts (1 cm2) for each micro-organism were microbiologically tested and eight grafts per antibiotic underwent viability tests against human umbilical vein endothelial cells (ECs). Fifteen grafts (5/antibiotic agent) underwent 15 min impregnation and contamination with 4 ml bacterial solution (optical density (OD (600 nm)): 0.20 ± 0.02). After 24-h-incubation, all grafts were washed with phosphate-buffered saline and underwent sonification to release viable adherent bacteria. OD (600 nm) of the solution was measured. Afterwards, six 1:10 dilution steps took place and colony-forming units (CFUs) were counted. RESULTS: Nebacetin showed comparable efficacy to daptomycin against Gram-positive bacteria. Both eradicated more efficiently S. epidermidis than rifampin (daptomycin:0, rifampin:5 ± 7.3, nebacetin:0 CFU ml(-1), P = 0.0003). All antibiotics showed comparable antibacterial activity against S. aureus. Nebacetin was more efficient than rifampin to eradicate Gram-negative organisms (P. aeruginosa: rifampin:1308 ± 252, nebacetin:8 ± 8 CFU ml(-1), P = 0.01, E. coli: rifampin:294 ± 159, nebacetin:0.2 ± 0.5 CFU ml(-1), P = 0.001), while only rifampin was toxic against ECs (daptomycin:30.88 ± 5.44, rifampin:5.13 ± 5.08, nebacetin:28.50 ± 3.82 ECs/field, P = 0.0003). CONCLUSIONS: Nebacetin showed excellent in vitro antibacterial activity against both Gram-positive and -negative pathogens representing an effective candidate for vascular graft impregnation.

Recommendations for reporting treatment of aortic graft infections.

The purpose of these recommendations is to provide a standard format for reporting treatment results and standardised epidemiologic data after aortic vascular graft infection to improve the comparison of clinical outcomes between different therapeutic approaches and different study populations. Analytical reporting standards for patients' characteristics, type and extent of the disease, type of treatment and study design are described. Adherence to these recommendations will improve clinical relevance, quality and comparability of future studies dealing with aortic vascular graft infections.

Effects of the ABO-mismatch between donor and recipient of cryopreserved arterial homografts.

AIM: Cryopreserved arterial homograft (CAH) is a well-established substitute material for in situ reconstruction of vascular infections. However, their degeneration remains serious complication. Although several studies propose ABO-mismatching between CAH-donor and -recipient as the main reason, the results are controversial. We compared the outcome between ABO-compatible and ABO-incompatible CAH recipients to evaluate the contribution of ABO-mismatching. METHODS: Between January 2004 and December 2007, a retrospective review in 32 patients who underwent CAH-implantation was performed. The patients were divided in ABO-incompatible (group A: 17/32 patients; 53%) and ABO-compatible (group B: 15/32 patients; 47%) to CAH donor. Leucocytes, platelets and C-reactive protein (CRP) levels were recorded during the in-hospital stay. These were correlated with the surface of implanted homograft (SIH). Mid-term survival- and freedom-from-reoperation (FFR) rates were also calculated. RESULTS: In both groups, peak of leucocytes and CRP was recorded on third postoperative day (POD3) and regarding platelets lowest values on POD1. Interestingly, a second CRP-peak was reported on POD8 in group A (A: 172±104mg/L vs. B: 75±55mg/L, P=0.01). No relationship between second CRP-peak and SIH was found. After 27 months median follow-up (range, 5-49 months), survival- (65% vs. 84%, P=0.28) and FFR-rates (94% vs. 93%, P=0.98) remained comparable. CONCLUSION: We consider that the second CRP-peak expresses an early cytoimmunologic response of ABO-incompatible recipients against CAH. However, we did not find any relationship between ABO-incompatibility and poor mid-term outcome in terms of reoperation or mortality. Longer surveillance of our patients is mandatory.

Carotid endarterectomy with or without concomitant aortocoronary bypass in elderly patients: an analysis of 599 procedures.

AIM: Carotid endarterectomy (CEA) has been established as an effective treatment of carotid artery disease. Controversial remains the performance of CEA in elderly patients. Aim of this study is to report the mid-term (30 days) neurological outcome in patients older than 75 years after CEA with or without simultaneous aortocoronary bypass (CABG). METHODS: 599 patients undergoing CEA from January 2000 to December 2007 were enrolled. Isolated CEA was performed in 398/599 (66%) patients (group A). In 201/599(34%) patients (group B) was performed a combined procedure (CEA/CABG). 90/398(23%) patients of group A (group A1) and 49/201(24%) patients of group B (group B1) were >75 years old. 308/398 (77%) patients of group A (group A2) and 152/201 (76%) patients of group B (group B2) were <75 years old. Mortality, TIA and stroke rates as well as pre- and postoperative Rankin scale (RS) were reported. RESULTS: In isolated CEAs, mortality was higher in group A1 (A1:1.1% vs A2:0%, P=0.51). We found no significant differences in rates of TIA (A1:4.4% versus A2:3.2%, P=0.79) or stroke (A1:2.2% versus A2:1.9%, P=0.98). In CEA/CABG, mortality was 0% in group B1 and 5.9% in group B2 (P=0.17). No significant differences in rates of TIA (B1:2% versus B2:3%, P=0.76) or stroke (B1:2% versus B2:5%, P=0.70) were reported. Preoperative RS was the only positive predictor for postoperative stroke in groups A1 (P=0.02) and B1 (P=0.001). CONCLUSION: CEA is an appropriate and safe procedure in elderly patients. Under consideration should be the performance of CEA in elderly patients with high preoperative RS.