Directional atherectomy with anti-restenotic therapy versus open repair in patients with restenotic disease after surgical revascularization of the common femoral artery.

BACKGROUND: This study evaluated the performance of directional atherectomy with anti-restenotic therapy (DAART) compared to surgery in patients with restenosis of the groin arteries after endarterectomy or femoral bypass anastomosis. METHODS: Consecutive patients with restenotic lesions from two vascular surgery units were retrospectively evaluated. Detailed medical history, type of previous reconstruction, anatomical and perioperative data, 30-day mortality and morbidity as well as data during follow-up were documented. The primary outcome measure was primary patency, whereas technical success, secondary patency, target lesion revascularization (TLR), freedom from major amputation, overall morbidity and mortality were additionally evaluated. RESULTS: The endovascular (25 patients) and surgical (17 patients) groups were comparable regarding the initial surgical reconstruction, demographics, comorbidities and medication. In the DAART group technical success was 100% without any residual stenosis >30%, distal embolization, perforation or bailout stenting. Hospital stay was shorter after DAART (medial 2 vs. 7 days, P<0.001), while more wound complications were documented in the surgical group within the first 30-days (29.4% vs. 0%, P=0.004). Primary patency, secondary patency and TLR were comparable between the groups (66.7% vs. 64.7%, HR 0.95, 95% CI 0.3-2.9, P=0.93, 86.4% vs. 93.8%, HR 0.65, 95% CI 0.65-6.6, P=0.71, 68% vs. 70.6%, HR 0.95, 95% CI 0.3-2.9, P=0.93, respectively). During follow-up no major amputation was observed, the improvement of the Rutherford class was comparable between the two groups and there were two deaths in the surgical group. CONCLUSIONS: In this study, DAART for restenotic atherosclerotic disease of the common femoral artery and its branches is a safe alternative to redo surgery and is associated with shorter hospital stay, fewer wound complications, comparable patency and freedom from TLR rates.

Intravascular lithotripsy-assisted percutaneous deep vein arterialization for no-option chronic limb-threatening patients and heavily calcified tibial occlusive disease.

PURPOSE: To report the first chronic limb-threatening ischemia (CLTI) patients who underwent an intravascular lithotripsy (IVL)-assisted percutaneous deep vein arterialization (pDVA). CASE REPORT 1: An 81-year-old patient presented with CLTI and a heavily calcified lesion of the popliteal artery and tibioperoneal trunk (TPT), with a distal tibial and foot arch occlusion. The patient underwent IVL and drug-coated balloon angioplasty for the distal popliteal artery and of the TPT to improve the inflow prior to pDVA. The wound situation remained stable without secondary procedure until the patient`s deaths due to complications of urosepsis 3 months later. CASE REPORT 2: A 64-year-old patient with rest pain of the left limb with a single-vessel tibial run-off (peroneal artery) and occluded pedal arch was treated with 3.5 mm IVL followed by a successful pDVA as mentioned above. IVL performed in the proximal posterior tibial artery to optimize the inflow to the circuit and change the compliance of the crossing point from the arterial to the vein system. The patient underwent repeat angioplasty of the plantar vein arch 5 months after the index procedure and thereafter remained asymptomatic during 2 years of follow-up. CONCLUSION: The combined use of IVL and pDVA could improve the patency of the reconstruction with clinical benefits in no-option CTLI patients.

Association of serum levels of osteopontin and osteoprotegerin with adverse outcomes after endovascular revascularisation in peripheral artery disease.

BACKGROUND: Osteoprotegerin (OPG) and osteopontin (OPN) are vascular calcification inhibitors with a known role in the atherosclerotic and inflammatory process. We investigated their relationship with adverse outcomes (restenosis/adverse cardiovascular events) after endovascular revascularisation of patients with peripheral arterial disease (PAD). METHODS: 203 consecutive patients were enrolled in the PAD group (PADG) and 78 age and sex-matched subjects with less than two cardiovascular risk factors served as control group (COG). PADG underwent standard medical assessment at baseline and 12 months after the procedure. During follow up major adverse cardiovascular events (MACEs) including arterial restenosis with need for reintervention were documented and the PADG was divided accordingly into two subgroups. RESULTS: During 12-month follow-up, 82 MACE were recorded (MACE subgroup). The rest of 124 PAD patients remained free of MACE (non-MACE subgroup). At baseline, OPG (9.89 ± 2.85 ng/ml vs 3.47 ± 1.95 ng/ml, p < 0.001) and OPN (79.99 ± 38.29 ng/ml vs 35.21 ± 14.84 ng/ml, p < 0.001) levels were significantly higher in PADG compared to COG, as well as in MACE subgroup compared to non-MACE subgroup (13.29 ± 3.23 ng/ml vs 10.86 ± 3 ng/ml and 96.45 ± 40.12 ng/ml vs 78.1 ± 38.29 ng/ml, respectively). An independent association of PAD with OPG and OPN was found in the whole patient cohort. Although OPG and OPN were significantly related to MACE incidence in the univariate analysis, multiple logistic regression analysis failed to detect any independent predictor of MACE within the PADG. CONCLUSION: Baseline high OPG and OPN levels were independently associated with PAD presence. Even higher levels of those biomarkers were detected among PAD patients with MACE, however, their prognostic role should be further clarified.

[Acute Complex Endovascular Aortic Repair - Off-the-shelf vs. Surgeon-modified Stent Grafts]. / Akute komplexe endovaskuläre Aortenchirurgie ­ Off-the-Shelf vs. Surgeon-modified Stentgrafts.

INTRODUCTION: Treatment of complex abdominal and thoracoabdominal aortic aneurysms is challenging. Open surgical repair is a high-risk operation, especially in emergency cases. Endovascular aneurysm repair with a patient-specific custom-made stent graft in patients with symptomatic or ruptured complex aortic aneurysms is not possible, due to the manufacturing time required. In such cases, alternative endovascular techniques can be used. RESULTS: The "off-the-shelf" and "surgeon-modified" stent grafts are valid options for the endovascular treatment of complex aneurysms in urgent and emergent patients. The former are standardised commercially manufactured fenestrated or branched stent grafts, which are available off-the-shelf with an anatomical feasibility in 50 - 80% of the patients. The "surgeon-modified" stent grafts refer to a technique, in which a commercially available stent graft is modified by the surgeon under sterile conditions directly before the implantation, in order to add the required fenestrations, scallops and/or branches. The modification takes approximately 60 - 120 min and haemodynamic stability of the patient is mandatory. Because of the off-label use of the commercial stent graft, detailed patient consent about the modification complications and risks should be performed whenever possible. A comparison of results on mortality and morbidity between "off-the-shelf" and "surgeon-modified" stent grafts has been published, although a direct comparison would be unfair for several reasons (different design, lack of extensive outcomes reports, long learning curve and different modification techniques). CONCLUSION: The "surgeon-modified" and "off-the-shelf" fenestrated/branched stent grafts are used in the treatment of high-risk patients with symptomatic or contained ruptured complex aneurysms. The outcomes of the two techniques are good, although the long-term durability of the former should be further investigated.

Endovascular management of subclavian-steal syndrome in a patient with post-traumatic dissection of an aberrant right subclavian artery.

BACKGROUND: An aberrant right subclavian artery is the most common congenital anomaly of the aortic arch and may cause symptoms due to aneurysmal dilatation, stenosis or occlusion. We present a case of subclavian-steal syndrome due to post-traumatic dissection of an aberrant right subclavian artery. METHODS AND RESULTS: A 50 year-old man presented with dizziness and fainting episodes after exercising his right arm and a systolic blood pressure gradient of 40 mm Hg between the 2 arms. Suspecting a subclavian steal syndrome, a computed tomography angiography was requested which revealed an aberrant right subclavian artery with a severe stenosis proximal to the ostium of the vertebral artery. Transfemoral digital subtraction angiography showed a local dissection of the aberrant right subclavian artery with late retrograde filling of the ipsilateral vertebral artery. The lesion was successfully treated with primary stent implantation (9 mm x 40 mm, LIFESTAR, BARD). On interrogation, the patient recalled an injury to the right arm after falling off a ladder 10 years earlier, as a possible post-traumatic cause for the dissection. He had an uneventful outcome and is symptom-free 12 months down the line. CONCLUSIONS: The combination of post-traumatic dissection of an aberrant right subclavian artery resulting to subclavian steal syndrome is an extremely rare scenario. Endovascular management is a safe, minimally invasive alternative to open surgery.

The Effect of Transfusion of Two Units of Fresh Frozen Plasma on the Perioperative Fibrinogen Levels and the Outcome of Patients Undergoing Elective Endovascular Repair for Abdominal Aortic Aneurysm.

BACKGROUND: We aimed to investigate whether the transfusion of 2 units of fresh frozen plasma (FFP) immediately post aneurysm exclusion has any effect on the perioperative fibrinogen levels and the outcome of patients undergoing elective endovascular repair (EVAR) of abdominal aortic aneurysm (AAA). METHODS: Consecutive infrarenal AAA patients undergoing elective EVAR with the bifurcated Endurant-II stent-graft (Medtronic) were recruited from 2 vascular units. The first unit has a routine policy of administering 2 units of FFP immediately upon aneurysm exclusion (FFP group), whereas the second unit has no such policy (control group). Serum fibrinogen levels were measured on admission and 24 hr post-EVAR and the perioperative change in fibrinogen (Δfib) was calculated (24-hr postoperative minus preoperative fibrinogen). The 2 groups were compared with regards to the perioperative fibrinogen levels (preoperative, 24-hr postoperative, and Δfib) and the outcome (endoleaks, reinterventions, major adverse cardiovascular events, death) during follow up. RESULTS: A total of 70 patients (41 in the FFP group, 29 controls) were examined. There were 68 men, the mean age was 70 ± 7 years and the maximum AAA diameter was 63.3 ± 13.8 mm. During the follow up (34 ± 19 months), a total of 6 endoleaks were recorded (2 type Ia, 2 type Ib and 1 type II). Mean preoperative fibrinogen, 24-hr postoperative fibrinogen and Δfib was 391.1 ± 92.8 mg/dL, 367.7 ± 97.8 mg/dL and -23.5 ± 51.02 mg/dL, respectively. There was a trend for the fibrinogen to fall 24 hr postprocedure, but this was not statistically significant (P = 0.07). There was a weak negative association between Δfib and endoleaks (P = 0.007, r = -0.29). Compared to controls, the FFP group had a higher 24-hr postoperative fibrinogen (401.8 ± 112.9 mg/dL vs. 319.3 ± 34.9 mg/dL, P < 0.0001) and a lower Δfib (-3.00 ± 56.01 mg/dL vs. -52.48 ± 21.15 mg/dL, P < 0.0001). No significant difference was observed between the 2 groups with regards to endoleaks, reinterventions, major adverse cardiovascular events, or deaths. CONCLUSIONS: Transfusion of 2 units of FFP postaneurysm exclusion prevents a significant drop in plasma fibrinogen 24 hr post-EVAR, but the impact on clinical outcome has yet to be defined.

Extension of Iliac Branch Device Repair Into the Superior Gluteal Artery Is a Safe and Effective Maneuver.

BACKGROUND: In some cases of complex aortoiliac endovascular repair, the hypogastric landing zone is suboptimal or even insufficient. This study aimed at the technical feasibility and at the outcome of iliac branch device (IBD) deployment with extension of the IBD into the superior gluteal artery (SGA). MATERIALS AND METHODS: This study involves a retrospective analysis of a prospectively maintained single-center cohort of patients with implantation of IBD for aortoiliac and postdissection aneurysms. The IBD cohort with landing zones in the hypogastric main trunk (IIA IBD) was compared with the IBD cohort with landing zones in the SGA (SGA IBD). The main outcome parameters were primary technical success, patency of the hypogastric branch, and freedom from IBD-specific secondary interventions within 30 days. Other outcomes of interest were long-term patency and freedom from buttock claudication, as well as the incidence of endoleaks. Group comparisons were made by univariate significance tests, and freedom from reintervention was analyzed with the Kaplan-Meier-method. RESULTS: From January 2015 to October 2017, a total of 46 IBDs were implanted in 40 patients (39 male; mean age, 71.9 ± 9.1 years). Nineteen of 46 (41.3%) IBDs were extended with at least one bridging stent graft into the SGA because of aneurysmal or short internal iliac artery (IIA). Technical success was achieved in 97.8% (96.3% for IIA IBD vs. 100% for SGA IBD, P = 0.163), and the primary ipsilateral limb patency rate was 100% within 30 days after the procedure. During a mean follow-up period of 19.8 ± 10.0 months (24.7 ± 10.8 for IIA IBD vs. 25.1 ± 9.8 for SGA IBD, P = 0.461), 11.1% IBDs in the IIA IBD group and 15.8% IBDs in the SGA IBD group needed secondary interventions (P = 0.33). Follow-up revealed no patients suffering from persistent buttock claudication or erectile dysfunction. One patient in the SGA IBD group died at late follow-up from a non-aneurysm-related cause. CONCLUSIONS: Extension of IBD into the SGA is a technically feasible and safe maneuver in the treatment of aortoiliac aneurysms with outcomes comparable to those when IBDs extend to the main trunk of the hypogastric artery.

Current evidence on aortic remodeling after endovascular repair.

Anatomical changes after endovascular repair (EVAR) of abdominal aortic aneurysms (AAAs) are thoroughly studied as they could affect the long-term postoperative outcome. The aim of the present study was to review the literature and summarize the recent data regarding the aortic remodeling and its clinical significance. A continuous aortic neck expansion is observed after EVAR and is more rapid at the first month and during the third postoperative year. This aortic neck dilation is not influenced by the type of proximal stent-graft fixation, is comparable to open surgical aneurysm repair and is most probably related with the natural progression of aneurismal disease. Aortic neck angulation reduces significantly immediately after EVAR and then continues to reduce slowly and gradually. Neck angulations ≥60° have a greater reduction compared to neck angulations <60°. An expansion of the common iliac arteries at the distal landing zone is also observed after EVAR and is more prominent in the first six postoperative months. A postoperative increase of the distance between superior mesenteric artery and iliac bifurcations (aortoiliac elongation) is described and is associated with increased type I endoleaks and reinterventions. The aneurysm sac diameter most frequently reduces after EVAR in absence of an endoleak and this aneurysm sac regression has been associated with the stent-graft type.

Meta-analysis of the accuracy of contrast-enhanced ultrasound for the detection of endoleak after endovascular aneurysm repair.

OBJECTIVE: The purpose of this systematic review and meta-analysis was to investigate the diagnostic accuracy of contrast-enhanced ultrasound (CEUS) for detection of endoleak after endovascular aneurysm repair (EVAR). METHODS: We searched electronic bibliographic databases for original articles comparing concurrent CEUS and computed tomography angiography for detection of endoleak after EVAR. We assessed the methodologic quality of the studies with the Quality Assessment of Diagnostic Accuracy Studies-2 tool. We constructed 2 × 2 contingency tables for all selected studies including true-positive, false-positive, false-negative, and true-negative results for all endoleaks and for type I and type III endoleaks. We used a mixed-effects logistic regression model to estimate summary sensitivity and specificity. We developed hierarchical summary receiver operating characteristic curves and calculated the area under the curve (AUC). RESULTS: We identified 26 studies reporting a total of 2638 paired scans in 2217 patients. The major risk of bias of the selected studies pertained to blinding for the index test and the reference standard. The pooled sensitivity and specificity of CEUS for all endoleaks were 0.94 (95% confidence interval [CI], 0.89-0.97) and 0.93 (95% CI, 0.89-0.96), respectively. The AUC was 0.98 (95% CI, 0.93-0.99). The summary estimate of sensitivity and specificity for type I and type III endoleaks was 0.97 (95% CI, 0.8-1.00) and 1.00 (95% CI, 0.99-1.00), respectively. The AUC was 1.00 (95% CI, 0.99-1.00). CONCLUSIONS: CEUS has a high sensitivity and specificity in the detection of endoleaks after EVAR. CEUS is a useful tool in EVAR surveillance.

Association Between Perioperative Fibrinogen Levels and the Midterm Outcome in Patients Undergoing Elective Endovascular Repair of Abdominal Aortic Aneurysms.

BACKGROUND: We investigated the potential association between perioperative fibrinogen levels and outcome in patients undergoing elective endovascular abdominal aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs). METHODS: Consecutive patients with an intact AAA undergoing elective EVAR with a specific bifurcated endograft (Endurant, Medtronic) were recruited between December 2012 and October 2016. Preoperative and 24-hr postoperative fibrinogen levels were recorded, and potential associations with outcome were tested. Primary outcome measures included endoleaks, lower limb ischemic complications, including endograft limb occlusion, and aneurysm-related reinterventions. RESULTS: Ninety-four patients (91 male, mean age 71.8 ± 8.0 years) with an intact AAA were enrolled in the study. The technical success was 98% (2 failures: 1 type Ia endoleak on completion angiography, 1 lower limb ischemia immediately postoperatively requiring femoral endarterectomy). There was 1 death during the first 30 days due to myocardial infarction (1%). Another patient died 15 months after the procedure from cardiac causes. During the existing follow-up (mean 14.8 ± 14.3 months), 14 patients (15%) developed an endoleak (4, type Ia endoleak and 10, type II endoleak), 6 patients (6.3%) had lower limb ischemia/endograft limb occlusion, and 10 patients (10.6%) required reintervention. Compared with the preoperative values, no significant change occurred with regard to the fibrinogen levels 24 hr after procedure (mean preoperative fibrinogen 360 ± 101 mg/dl vs 24-hr postoperative fibrinogen 349 ± 105 mg/dl, P = 0.1). Neither preoperative nor 24-hr postoperative fibrinogen levels were significantly associated with the development of endoleaks, lower limb ischemia, or reinterventions. However, the difference in fibrinogen levels (baseline to 24 hr after procedure) was significantly higher in patients with endoleaks (median -65 mg/dl vs. 15 mg/dl, P = 0.04). CONCLUSIONS: Perioperative fibrinogen levels may play a role in predicting midterm outcomes in patients undergoing elective EVAR and appears to be associated, directly or indirectly, with the development of endoleaks. Further studies are needed to investigate these findings and explore future therapeutic implications.

Changes in circulating markers of coagulation and fibrinolysis after EVAR.

INTRODUCTION: The presence of an abdominal aortic aneurysm (AAA) is associated with increased thrombin formation, fibrin turnover and fibrinolysis. EVIDENCE ACQUISITION: The aim of this study was to review the relevant literature and summarize the evidence regarding the impact of endovascular repair on the circulating markers of coagulation and fibrinolysis postprocedure. EVIDENCE SYNTHESIS: The main findings are that the increased thrombin activation, and formation, as well as fibrinolysis, in patients with AAA is exacerbated after endovascular repair in the short-term and the mid-term, implying that this may be a period associated with an increased likelihood for adverse cardiovascular events. It is estimated that this prothrombotic state is normalized within a year of the endovascular procedure. Furthermore, elevated levels of specific markers of fibrinolysis are associated with the presence of an endoleak during the follow-up imaging and the clinical implications of these findings merit investigation. CONCLUSIONS: Further and larger studies are needed to explore the impact of these changes in coagulation and fibrinolysis on the outcome of endovascular repair in patients with AAA.

Vascular calcification biomarkers and peripheral arterial disease.

BACKGROUND: The aim of this study was to evaluate the association of the calcification regulators, osteopontin (OPN) and osteoprotegerin (OPG), which are involved in vascular calcification and atherosclerosis in patients with peripheral arterial disease (PAD). METHODS: A PubMed search of the English language literature was undertaken to identify articles that examine the role of the vascular calcification markers (OPN and OPG) in patients with PAD. The search retrieved 94 articles. After excluding non-relevant articles, only 11 studies qualified for review. RESULTS: In 8 studies, OPG levels were correlated with the presence, severity, and progression of PAD, whereas in one article, OPG levels were not significantly elevated. In 2 studies, OPN levels were associated with PAD and vascular stiffness. CONCLUSIONS: The results from clinical and experimental research regarding the role of vascular calcification markers in PAD are controversial, although most of the studies suggest a positive correlation. Larger studies are needed to determine the exact pathway of vascular calcification, mediated by calcification markers, in patients with PAD.

Endovascular Repair of Abdominal Aortic Aneurysms with the Anaconda™ Stent Graft: Mid-term Results from a Single Center.

INTRODUCTION: We aimed to report our experience with the Anaconda™ stent graft (Vascutek, Terumo, Inchinnan, Scotland, UK) for the endovascular treatment of abdominal aortic aneurysms (AAAs). METHODS: The vascular unit database was interrogated to identify all AAA patients who underwent endovascular repair with the Anaconda™ device between March 2007 and June 2014. The peri-operative, short-term, and mid-term outcome was recorded focusing on complications and re-interventions. RESULTS: Sixty-eight patients had been treated during the study period. Seven of these were symptomatic, one presented with an inflammatory aneurysm, and five presented with a ruptured AAA. The primary and the assisted primary technical success were 86.7 and 97.1%, respectively. There was no 30-day mortality in the elective or symptomatic group, but two of the ruptured AAA patients died. During a mean follow-up of 29 months (range 1-87), 14 patients died, none from aneurysm-related causes. A total of 11 endoleaks (17.5%) were detected in 10 patients during follow-up (1 type Ia, 4 type Ib, 6 type II), 4 of which required re-intervention (all for type Ib endoleak). Two iliac limbs occluded during the follow-up. The estimated overall survival, endoleak-free survival and re-intervention-free survival probability were 88.2, 78.4, and 83.4% at 1 year; 85.9, 73.8, and 78.9% at 2 years; and 80.6, 71.3, and 70.5% at 3 years, respectively. CONCLUSION: Based on this series, the Anaconda™ stent graft appears to be safe and effective for the endovascular treatment of AAAs. Both the short-term and the mid-term results are satisfactory.