Percutaneous Large-Bore Pulmonary Thrombectomy with the FlowTriever Device: Initial Experience in Intermediate-High and High-Risk Patients.

OBJECTIVES: This retrospective cohort study investigates outcomes of patients with intermediate-high and high-risk pulmonary embolism (PE) who were treated with transfemoral mechanical thrombectomy (MT) using the large-bore Inari FlowTriever aspiration catheter system. MATERIAL AND METHODS: Twenty-seven patients (mean age 56.1 ± 15.3 years) treated with MT for PE between 04/2021 and 11/2021 were reviewed. Risk stratification was performed according to European Society of Cardiology (ESC) guidelines. Clinical and hemodynamic characteristics before and after the procedure were compared with the paired Student's t test, and duration of hospital stay was analyzed with the Kaplan-Meier estimator. Procedure-related adverse advents were assessed. RESULTS: Of 27 patients treated, 18 were classified as high risk. Mean right-to-left ventricular ratio on baseline CT was 1.7 ± 0.6. After MT, a statistically significant reduction in mean pulmonary artery pressures from 35.9 ± 9.6 to 26.1 ± 9.0 mmHg (p = 0.002) and heart rates from 109.4 ± 22.5 to 82.8 ± 13.8 beats per minute (p < 0.001) was achieved. Two patients died of prolonged cardiogenic shock. Three patients died of post-interventional complications of which a paradoxical embolism can be considered related to MT. One patient needed short cardiopulmonary resuscitation during the procedure due to clot displacement. Patients with PE as primary driver of clinical instability had a median intensive care unit (ICU) stay of 2 days (0.5-3.5 days). Patients who developed PE as a complication of an underlying medical condition spent 11 days (9.5-12.5 days) in the ICU. CONCLUSION: In this small study population of predominantly high-risk PE patients, large-bore MT without adjunctive thrombolysis was feasible with an acceptable procedure-related complication rate.

Panorama actual e implicaciones clínicas del registro multicéntrico pELVIS para el tratamiento de aneurismas de la bifurcación ilíaca mediante el dispositivo de rama ilíaca / Insights and clinical implications of the multicentre pELVIS registry for the treatment of aneurysms of the iliac bifurcation using the iliac branch device

No disponible

Gender-related outcomes of chimney EVAR within the PERICLES registry.

OBJECTIVE: Gender-related differences in outcomes in complex endovascular aortic repair have not been profoundly investigated. Use of low profile abdominal devices as in chimney endovascular repair may be beneficial for female patients with pararenal pathologies. With the chimney technique, there is no need for large introduction sheaths. This could be an advantage in case of smaller in diameter iliac access especially in combination with stenosis or elongation. Aim of the present study was to compare the perioperative and mid-term outcomes between males and females patients treated with the chimney/snorkel technique for pararenal aortic pathologies. METHODS: The PERICLES registry collected the world wide experience with the chimney technique. According to the gender, patients were classified in two cohorts. Primary endpoints were freedom from occlusion of the chimney grafts and reintervention. Secondary endpoints included access site complications and need for surgical or interventional revision, Endoleak Type I rate, 30-day overall complications and mortality. Univariate comparison P-values were generated using either the likelihood ratio χ2 test, the Fisher exact test, the Wilcoxon rank sum test, or the log rank test. Kaplan-Meier curves estimated the outcomes in the long run. RESULTS: A total of 412 patients underwent Ch-EVAR, 71 (17%) females and 341 (83%) males with a mean age for both groups being 74 years were included in the present study. After 36 months of mean follow-up, no statistically significant difference was observed between the two cohorts regarding re-interventions ( P= .44). Freedom from occlusion rates at 36 months did not differed between the two groups (females 84% vs. 80% for males ( P= .033). For patients receiving more than one chimney stent, the odds of having a complication did not differ between males and females (M:F OR = 2.0, 95% CI: 0.6-6.4, P = 0.228); 30-day mortality was 0% in the female group, instead five male patients died within one month. ( P = 0.59). The incidence of acute renal failure was low in both groups without statistical difference: 2 (3.1%) vs. 13 (4.6%) 58 ( P = 1.00). Neither patient received an endoconduit to insert the abdominal device. CONCLUSIONS: No statistically significant difference regarding the freedom from reintervention and chimney graft patency was observed between the two genders. The results highlight the beneficial use of the chimney technique in female patients who can have potentially higher risk of access complications.

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.

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.

The endovascular performance spectrum of vascular surgery departments in Germany: Results of an online survey among senior department physicians.

AIM: To survey the scope of vascular surgery services in Germany. METHOD: A total of 308 senior German vascular surgeons received a 19-point questionnaire pertaining to department structure and scope of services. Of these surgeons 223 replied between 16 August 2015 and 23 October 2015 (response rate 72 %), with 62.2 % reporting an additional qualification as an endovascular surgeon according to the guidelines of the German Society for Vascular Surgery and Vascular Medicine (Deutsche Gesellschaft für Gefäßchirurgie und Gefäßmedizin, DGG) and 43.5 % as a DGG® endovascular specialist. RESULTS: The number of respondents fully authorized to train in vascular surgery was 71.3 %, while 28.3 % were authorized for limited training. Authorization as a DGG® endovascular surgeon was reported by 24.2 % and authorization as a DGG® endovascular specialist by 17 % of respondents. All respondents performed endovascular interventions on pelvic vessels and 99.1 % also reported carrying out femoral and popliteal endovascular interventions. Endovascular procedures in crural vessels were carried out by 90.1 % and 93.7 % of vascular surgeons performed endovascular procedures in the region of the abdominal aorta (segment V), arteriovenous (AV) fistulas and shunts (85.2 %), upper extremity vessels (80.3 %), the thoracic aorta (segment III, 68.2 %), renal arteries (62.8 %) and visceral aorta (segment IV, 60.5 %). In all 43.5 % of respondents reported experience with endovascular procedures on the carotid bifurcation. Percutaneous arterial procedures formed the focus of endovascular activity, totalling on average 259 interventions per year and department, followed by diagnostic angiography (without intervention) at 166 procedures per year and hybrid arterial interventions at 141 interventions per year. CONCLUSION: This survey revealed a high level of endovascular expertise among vascular surgeons in Germany. This applies not only to the scope of endovascular activities in diagnosis and treatment but also to the number of estimated annual procedures.

Perioperative quality assessment of varicose vein surgery : Commission for quality assessment of the German Society for Vascular Surgery.

PURPOSE: An estimated 350,000 varicose vein (VV) surgical procedures are performed in Germany each year, with annual treatment costs amounting to about 800 million Euro. To evaluate the outcome quality of this treatment, we examined the intraoperative and postoperative complication rates on record in the VV surgery quality assessment (QA) registry of the German Society for Vascular Surgery (GSVS). METHODS: Data on 89,647 patients (27,463 men, 62,184 women; average age 52.8 years, range 15-96 years) collected in the GSVS varicose surgery QA registry between 2001 and 2009 were analyzed. In these patients, 95,214 surgical procedures were performed on 105,296 limbs. Complication rates were correlated with the type of VV surgical procedure, with whether surgery was performed on an inpatient or outpatient basis, and with the CEAP classification (C stage) and American Society of Anaesthesiologists' (ASA) stage at the time of surgery. Statistical analyses were performed using a chi-square test, a Cochrane-Armitage test, and an odds ratio calculation. RESULTS: Intraoperative and postoperative complication was low (0.18 and 0.43 %, respectively), being the lowest for radiofrequency ablation (0.25 %) but not differing significantly from those for endovenous laser therapy and high ligation and stripping. General complications occurred in 0.67 % of outpatients and in 0.25 % of inpatients, a highly significant statistical difference (p < 0.0001, chi-square test). With regard to C stage, the higher the stage, the higher the local complication rate. A clear correlation was also found between preoperative ASA stage and postoperative complication rates: for ASA stages I and II, the complication rates were 0.2 and 0.5 %, respectively, increasing for ASA stage III to 1.2 % and for ASA IV to 2.2 %. The differences between the ASA classes were highly statistically significant (p < 0.0001, Cochrane-Armitage test) CONCLUSIONS: Outcome quality as reflected in the intraoperative and postoperative complication rates was very good for all patients undergoing inpatient or outpatient VV surgery. Data from the GSVS QA registry shows that VV surgery is performed with very good perioperative results in specialized centers in Germany.

[Drug-coated balloons in the treatment of peripheral artery disease (PAD). History and current level of evidence]. / Medikamentenbeschichtete Ballonkatheter in der PAVK­Behandlung. Entwicklung der Methode und aktuelle Studienlage.

BACKGROUND: Despite initially encouraging technical success after femoropopliteal PTA, restenosis remains the major challenge in patients with peripheral artery disease (PAD). The main cause of restenosis is neointimal hyperplasia which can be suppressed by antiproliferative drugs. Drug-coated balloons (DCB) or drug-eluting stents (DES) are used for the inhibition of restenosis. OBJECTIVES: The present article gives an overview of DCB development, actual DCB systems for femoro- and infrapopliteal use, displays the outcomes of randomized clinical trials and the discusses the evidence for the DCB treatment in PAD. METHODS: A systematic literature search was performed in i) medical journals (i. e. MEDLINE), ii) in international registers for clinical studies (i. e. www.clinicaltrials.gov ) and in iii) scientific session abstracts. RESULTS: The clinical evidence of the PTX-DCB of the first and following generation has been shown in several controlled randomized trials. CONCLUSIONS: Major advantages of the DCBs lie in leaving no stent scaffold behind, the immediate release of high drug concentrations with a single dosage, their efficacy in areas, where stents have been contra-indicated until now and its use for secondary interventions. As their effect seems to be limited in severely calcified lesions, prior plaque preconditioning or removal could be advantageous. First positive results data supporting this hypothesis do exist.

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.

[Perioperative mortality following repair for abdominal aortic aneurysm in Germany : Comparison of administrative data of the DAK health insurance and clinical registry data of the German Vascular Society]. / Perioperative Letalität bei der Versorgung abdomineller Aortenaneurysmen in Deutschland : Ein Vergleich von Routinedaten der DAK-Gesundheit mit Registerdaten der DGG.

OBJECTIVE: This study determined whether the routine data of a single health insurance company (DAK health) can allow equivalent statements on hospital mortality of endovascular (EVAR) and open (OR) repair of intact (iAAA) and ruptured (rAAA) aortic aneurysms (AAA) in Germany in comparison to clinical registry surveys of the German Vascular Society (GVS). METHODS: The study compared two cohorts that were comparable in group sizes but not identical in terms of the duration of treatment and the selection of the centers. The GVS registry included 5080 patients with iAAA and 485 with rAAA and the DAK data consisted of 5182 patients with iAAA and 576 with rAAA. In GVS (in brackets DAK) 72.6 % (71.0 %) of patients with iAAA received EVAR and 27.4 % (29 %) OR, with rAAA 34.6 % (26.9 %) of patients received EVAR and 65.4 % (73.1 %) OR. Both cohorts were comparable with respect to patient age and gender distribution. RESULTS: Intact AAA: the hospital mortality rate in GVS (DAK in brackets) was 0.95 % (1.4 %) with EVAR and 4.7 % (5.5 %) with OR. For patients less than 80 years old the statements were almost identical when the hospital mortality in the GVS and DAK registers constituted 0.85 % and 0.9 % after EVAR and 3.8 % and 4.0 % after OR, respectively. Patients over 80 years old in particular had a benefit by EVAR as the hospital mortality in GVS (DAK in brackets) was 1.3 % (2.6 %) with EVAR vs. 13.9 % (17.4 %) with OR. A benefit by EVAR was also seen in women. Ruptured AAA: the hospital mortality rate in GVS (DAK in brackets) was 19.6 % (27.1 %) with EVAR and 38.5 % (42.0 %) with OR. Again, particularly patients over 80 years old showed an advantage with EVAR where the hospital mortality was 31.0 % (34.3 %) with EVAR vs. 56.7 % (61.3 %) with OR in this group. CONCLUSION: Hospital mortality is an important quality parameter of endovascular and open repair of iAAA and rAAA. Administrative data of a health insurance company can be used to provide representative and comprehensive statements on inhospital mortality.

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.

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.

[Vascular medicine needs more evidence: recent results and meta-analyses for the treatment of diabetic feet]. / Die Gefäßmedizin braucht mehr Evidenz: Aktuelle Ergebnisse und Metaanalysen zur Behandlung des diabetischen Fußes.

BACKGROUND: This overview comments on clinical trials and meta-analyses from the literature on the treatment of diabetic feet. METHODS: For the literature review, the MEDLINE database (PUBMED) was searched under the key words "diabetic foot". Publications of the last three years (2012 to 2014) were extracted. RESULTS: For patients with diabetic feet, both endovascular (ER) and open (OR) revascularisation techniques are possible. There are not sufficient data to demonstrate whether open bypass surgery or endovascular interventions are more effective in these patients. However, registries show that ER has now in terms of quantity become the preferred method. Angiosome-targeted revascularisation has to be considered in these situations. For the local treatment of a diabetic foot ulcer a variety of dressings are available, the evidence for their recommendation is low. Dressing cost and the wound management properties, e.g. exudate management therefore can influence the choice of dressing. There is no evidence that more expensive dressings as compared to basic dressings offer advantages in terms of healing. In plantar diabetic foot ulcers, non-removable off-loading devices regardless of type are more likely to result in ulcer healing than removable off-loading devices, presumably, because patient compliance with off-loading is facilitated. Meaningful pressure-relieving interventions for treating diabetic foot ulcers also include Achilles tendon lengthening, a plantar fascia release and percutaneous flexor tenotomy. The value of a standardised treatment protocol carried out by a specialist team could be proven in large registries based on decreasing amputation rates. CONCLUSION: This survey reveals a significant disparity between the large number of treatment recommendations and their evidence. For the future, therefore it is imperative to implement nationwide register surveys with respect to treatment and outcome of these patients.

[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.

INCRAFT® Stent-Graft System: one-year outcome of the INNOVATION Trial.

AIM: Endovascular repair has surpassed open surgical treatment as the most common procedure in patients with abdominal aortic aneurysms (AAA), yet its applicability remains limited to those with aortoiliac anatomy suitable for the introduction and deployment of the devices. The current study was performed to assess the safety and efficacy of INCRAFT® (Cordis Corporation, Bridgewater, NJ), an ultra-low-profile device for the treatment of AAA. METHODS: The INNOVATION study is a first in human prospective, multicenter trial involving 6 centers in Europe. From March 2010 to June 2011 60 patients with asymptomatic AAA were treated with the INCRAFT® bifurcated Stent-Graft System. The main inclusion criteria were a proximal aortic neck of 15 mm or more in length and up to 27 mm in diameter; iliac landing zones greater than 10 mm in length and between 9 and 18 mm in diameter; an access vessel large enough to accept the 14F outer diameter of the delivery system; and an aortic bifurcation >18 mm in diameter. The primary endpoint was technical success at one-month; one-year safety endpoints included the absence of device- or procedure-related major adverse events; absence of type I or III endoleaks; and maintenance of device integrity through one year of follow-up. RESULTS: Among 60 patients treated at six centers, the primary endpoint was met in 56 of 58 patients (97%; 95% CI, 88-100%) who came back for one month follow-up, two patients did not come back for their one month follow-up assessments but remained enrolled in the study. Fifty-six had one-year follow-up data showing 100% freedom from aneurysm enlargement with absence of type I and III endoleaks in all patients. There were two patients (3.6%) with a type Ia endoleak which was successfully treated with secondary endovascular intervention in both occasions. Core laboratory evaluation of the postoperative imaging studies documented absence of endograft migration, stent fracture, or limb occlusion. A single patient (1.8%) died within one year due to sepsis unrelated to the AAA. CONCLUSION: The results of the INNOVATION study with the INCRAFT® Stent-Graft are encouraging, with satisfactory clinical outcome and device durability through one-year of follow-up. The INCRAFT® device is a novel ultra-low-profile endograft that holds promise to broaden the patient population eligible for endovascular aneurysm repair.

Midterm results of the transarterial use of Onyx in the treatment of persisting type II endoleaks after EVAR.

AIM: Type II endoleaks with growing aneurysm sac >5 mm in diameter after EVAR require treatment. Different treatment options have been reported. The aim of this study was to evaluate the use of an ethylene-vinyl alcohol copolymer (Onyx) in an endovascular approach. METHODS: Between January 2010 and December 2011, 10 consecutive patients with persistent type II endoleaks leading to aneurysm growth >5 mm were treated in our center by transarterial Onyx embolization by super selective cannulation of the endoleak with microcatheters. Technical success was defined as transarterial Onyx deployment directly into the aneurysm sac. Clinical success was defined as stable or shrinking axial aneurysmal diameter during follow- up using an angiographic computed tomography. RESULTS: Ten patients with 13 persistent type II endoleaks leading to aneurysm sac growth of >5 mm were identified in the time period. Technical success was 92% (12/13 patients). Two patients underwent a staged procedure because several, unconnected type II endoleaks were present. In one patient a cannulation of the inflow vessel responsible for the endoleak was not possible, continued efforts led to a rupture of the hypogastric artery which was treated by covered stent implantation. In one patient an extravasation of onyx out of the aneurysm sac into the inferior vena cava during the embolization process made a transvenous goose snare maneuver necessary to retrieve the dislocated copolymer. No further complications were observed during the mean follow-up of 19.8 months (range, 3-31 months). In all patients with successful embolization the aneurysm sac remained stable or was decreased within the follow-up period. CONCLUSION: Use of Onyx in the endovascular treatment of type II endoleaks after EVAR is feasible, safe when accurately deployed and efficient. Further studies are necessary to evaluate the value of the different treatment modalities (translumbar vs. transarterial).

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.