Systematic review of atherectomy of inguinal arteries for atherosclerotic lesions.

INTRODUCTION: Surgical endarterectomy represents the gold standard for the treatment of atherosclerotic lesions of the groin vessels. Endovascular treatment such as atherectomy with or without drug coated angioplasty (DCA) of the so called no stenting zones, i.e. inguinal and popliteal vessels, is gaining growing acceptance as alternative option to open surgery. This systematic review aims to scrutiny the current clinical evidence regarding atherectomy and DCA for the common artery (CFA). EVIDENCE ACQUISITION: We conducted an exhaustive research in multiple platforms (Medline, PubMed, Cochrane, Google Scholar, Embase) on studies over atherectomy and angioplasty for inguinal atherosclerotic lesions published between 2000 and 2021. As search strategy we used a wide list of MeSH items, words, synonyms. Bibliographies of review articles were checked for further relating studies regarding atherectomy of CFA. A qualitative and quantitative data analysis was carried out. EVIDENCE SYNTHESIS: Fifteen studies were included in the qualitative review. Not all studies were focused only on atherectomy of inguinal vessels, despite including such treatment. Hence, data regarding this treatment were not exhaustive. A fairly homogeneous data analysis was possible in 7 of 15 studies. The remaining 8 studies were qualitatively analyzed but not included in the statistical analysis. In all 7 included studies directional atherectomy and DCA under filter protection were carried out. In this subgroup, overall, 497 patients were treated with atherectomy. Sixty-eight percent of the patients were males. Rutherford class from 1-3 dominated against 4-6 (63% vs. 37%). Mean technical success rate was 96%, with a primary and secondary patency rate of 92% and 98% respectively at one year. Procedure related vascular complications ranged from 1% to 6%. CONCLUSIONS: Current literature about atherectomy for inguinal arteries is scant, data are inhomogeneous and so are treatment modalities. Nevertheless, the results of this systematic review suggest that this endovascular strategy is feasible with good short and midterm results. Prospective trials with larger patient cohorts are necessary to confirm these preliminary results.

Optical coherence tomography guided directional atherectomy with antirestenotic therapy for femoropopliteal arterial disease.

BACKGROUND: Optical coherence tomography (OCT)-guided directional atherectomy enables a real-time visualization of the arterial wall during plaque debulking and might optimize vessel preparation prior to drug-coated balloon (DCB) angioplasty. Nonetheless there is a paucity of data reporting on the outcomes of OCT-guided directional atherectomy with antirestenotic therapy (DAART). Aim of this study was to evaluate the performance of OCT-guided DAART in the treatment of femoropopliteal atherosclerosis. METHODS: Patients treated by OCT-guided DAART for femoropopliteal occlusive disease between January 2015 and December 2016 were included into this retrospective, single-center, single-arm analysis. The primary measure outcome of this study was primary patency rate (PPR). Secondary outcomes were technical success rate (TSR), secondary patency rate (SPR) and freedom from target lesion revascularization (TLR). RESULTS: Thirty-three patients (N.=33, mean age 67±8 years) and 37 lesions were included into this analysis. The median follow-up time was 15 months (interquartile ratio (IQR): 4-21). The majority of patients presented with lifestyle limiting claudication (N.=25, 75%) and de novo atherosclerotic disease (N.=25, 68%). Median lesion length was 70 mm (IQR: 27-104), while 35% (N.=13) of the lesions were chronic total occlusions. Vessel wall calcification was present in 22% (N.=8) of the treated vessels. The mean luminal gain after atherectomy was 52±17% and the median gain after DAART amounted to 68% (IQR: 58-91). The TSR was 95%. The overall 12 months PPR was 93% whereas the SPR and the freedom from TLR at 12 months were 95% and 100% respectively. A single target vessel perforation (N.=1, 3%) and 2 peripheral embolizations (N.=2, 5%) were observed. The bailout stenting rate was 3% (N.=1) and the final angiography did not reveal any flow limiting dissection. An aneurysmatic degeneration of the target vessel was observed in 2 lesions (5%). CONCLUSIONS: In this study, OCT-guided DAART was associated with sufficient luminal gain, low rates of bailout stenting and perioperative adverse events and led to very promising 12-month outcomes.

Outcome After Crossing Femoropopliteal Chronic Total Occlusions Based on Optical Coherence Tomography Guidance.

AIMS: The crossing of chronic total occlusions (CTOs) is the key step for an endovascular treatment. The Ocelot system is a novel device that combines a steerable drilling tip with optical coherence tomography (OCT) technology. It provides intraluminal imaging to help the crossing of CTOs in the femoropopliteal segment. Aim of the study was to determine early and midterm results after recanalization with this device. METHODS AND RESULTS: During a period of 16 months, 84 CTOs were treated using the Ocelot system and prospectively registered. The primary end points were technical success and the primary and secondary patency of the lesion. Risk factors associated with early and midterm results were also analyzed. In all, 58 (69.0%) lesions were treated for intermittent claudication, 26 (31.0%) for critical limb ischemia, 34 (40.5%) were classified as Trans-Atlantic Inter-Society Consensus II D lesions, and 22 (26.2%) showed severe calcifications. The technical success rate was 72.6%. During 36 months of follow-up (mean 25.9), there were 10 reinterventions. The primary and secondary patency at 36 months were 54.2% and 68.1%, respectively. CONCLUSIONS: In our experience, the Ocelot system would appear to be a safe and effective tool for increasing the applicability of endovascular techniques. However, the midterm results did not show drastic improvement.

Results of primary stent therapy for femoropopliteal peripheral arterial disease at 7 years.

OBJECTIVE: Primary stenting is a well-established treatment option for femoropopliteal arterial disease. However, there is a paucity of data concerning the performance of this modality at ≥5 years. This study evaluated the long-term clinical and radiologic outcomes of primary stent therapy in patients with femoropopliteal arterial disease. METHODS: A prospective data collection and analysis was conducted in patients undergoing primary stent placement in femoropopliteal lesions between September 2006 and September 2007. The EverFlex (Medtronic/Covidien, Plymouth, Minn) bare-metal stent was used. The primary outcome of this study was the primary patency rate. Secondary outcomes were secondary patency rate, amputation-free-survival (AFS), and freedom from target lesion revascularization (TLR). A Cox regression analysis identified risk factors for the primary and the secondary measure outcomes. RESULTS: Included were 89 patients (102 stents). The prevalence of critical limb ischemia was 34% (n = 30). The initial angiography revealed a TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease C/D lesion in 31 patients (35%). Occlusions were present in 49 patients (55%), and the mean lesion length was 116 ± 33 mm. Popliteal artery disease was present in 39 treated limbs (35%). The primary patency rate at 1, 3, 5, and 7 years was 73%, 64%, 47%, and 33% respectively. At 7 years, secondary patency rate was 67%, freedom from TLR was 47%, and the AFS was 73%. Cox regression analysis revealed a decreased AFS among diabetic patients (hazard ratio [HR], 2.6; 95% confidence interval [CI], 1.08-6.28; P = .03), whereas secondary endovascular interventions showed a protective effect for AFS (HR, 0.14; 95% CI, 0.03-0.65; P = .01). Popliteal artery disease was identified as independent risk factor for secondary interventions (HR, 2.07; 95% CI, 1.05-4.06; P = .04) and TLR (HR, 1.99; 95% CI, 1.03-3.83; P = .04). Critical limb ischemia was associated with an increased incidence of surgical conversion owing to endovascular treatment failure (HR, 5.46; 95% CI, 2.44-12.17; P < .001). CONCLUSIONS: This study found primary stenting was associated with acceptable clinical and radiologic long-term outcomes. Diabetes was associated with poor AFS, and popliteal artery involvement correlated with an increased need for reinterventions. AFS was better among patients undergoing secondary procedures.

Validation of the Wound, Ischemia, foot Infection (WIfI) classification system in nondiabetic patients treated by endovascular means for critical limb ischemia.

BACKGROUND: The Society for Vascular Surgery Lower Extremity Guidelines Committee developed the Wound, Ischemia, foot Infection (WIfI) a classification system to predict the amputation risk in patients with critical limb ischemia (CLI). A number of published studies have already evaluated its prognostic value. However, most of the included patients were diabetic, and the validation was done independent of the revascularization procedure. This single-center study evaluated the prognostic value of WIfI stages in nondiabetic patients treated by endovascular means. METHODS: A retrospective analysis was performed of prospectively collected data of nondiabetic patients treated by endovascular means between January 2013 and September 2014. All patients were classified according to their wound status, ischemia index, and extent of foot infection to four classes: very low risk, low risk, moderate risk, and high risk. Comorbidities and vascular lesions for each group were analyzed. The prognostic value of WIfI was analyzed based on the amputation-free survival, overall survival rate, and freedom from amputation at 12 months. RESULTS: Data from 302 CLI patients treated in the study period were reviewed. A total of 219 patients (73%) underwent an endovascular intervention, and among them, 126 nondiabetic patients (58%) were enrolled in this study. Most patients were classified as low risk (33%), and the prevalence of very low-risk, moderate-risk, and very high-risk patients was 23%, 23%, and 21%, respectively. The modified Edifoligide for the Prevention of Infrainguinal Vein Graft Failure (PREVENT III) score was statistically significantly higher in the high-risk group (5.2 ± 2.4) than in the very low-risk, low-risk, and moderate-risk groups (4.3 ± 2.5, 3.5 ± 2.3, 4.5 ± 2.2, respectively; P = .048). One major amputation (1%) was performed during the hospital stay in a high-risk patient. Mean follow-up was 14 ± 8 months. The amputation-free survival at 12 months was 87%, 81%, 81%, and 62%, in the very low-risk, low-risk, moderate risk, and very high-risk groups, respectively (P = .106). The difference was statistically significant between the very low-risk and high-risk groups (hazard ratio, 3.4; 95% confidence interval, 1.1-10.3; P = .029). A similar trend was also observed for 1-year survival between the very low-risk and the high-risk groups (87%, 84%, 81%, 65%; P = .166). The amputation rate during the follow-up time was 0%, 2% (n = 6), 3% (n = 5), and 12% (n = 9) for the very low-risk, low-risk, moderate-risk, and very high-risk groups, respectively (P = .033). CONCLUSIONS: The WIfI classification system predicted the amputation risk and survival in this highly selected group of nondiabetic CLI patients treated by endovascular means, with a statistically significant difference between very low-risk and high-risk patients already at 1 year.

Use of parallel grafts to save failed prior endovascular aortic aneurysm repair and type Ia endoleaks.

OBJECTIVE: The aim of this study was the evaluation of the clinical and radiologic outcomes of parallel grafts in the treatment of patients with failed prior endovascular aneurysm repair and type Ia endoleak. METHODS: Prospectively collected clinical and radiologic data of consecutive patients with prior endovascular aneurysm repair and evidence of type Ia endoleak were analyzed. All patients were treated between January 2009 and November 2014 by use of parallel grafts, ie, chimney/snorkel or periscope grafts and abdominal endovascular devices. Primary outcome of the study was the technical success. Secondary outcomes were patency of the chimney grafts and shrinkage of aneurysm morphology. RESULTS: Technical success was 94.4% (17 of 18). One patient showed evidence of persistent type Ia endoleak after triple chimney graft placement and treated by Onyx embolization (Covidien, Plymouth, Minn) successfully. The mean preoperative and postoperative aneurysm diameters were 7.1 ± 1.7 and 7.0 ± 2 cm. Primary patency of the chimney grafts was 96.7% and assisted patency was 100% after successful retrograde recanalization of an acute occlusion of the superior mesenteric artery from the celiac trunk and the gastroduodenal artery. One patient who had undergone the sandwich technique with transfemoral placement of the flexible Viabahn (W. L. Gore & Associates, Flagstaff, Ariz) due to impossible catheterization of the target vessel from the upper extremity presented with contained rupture caused by gutter-associated endoleak and underwent urgent embolization with Onyx successfully. No procedure-related death or open conversion was observed in the entire follow-up period. CONCLUSIONS: Use of parallel grafts showed midterm safety and feasibility with low incidence of persistent endoleaks requiring intervention or progression of aneurysm diameter. Reproducible results from other vascular centers will establish the chimney technique in the treatment of type I endoleaks as a viable endovascular modality.

Use of iliac branch devices for endovascular repair of aneurysmal distal seal zones after EVAR.

PURPOSE: To assess the feasibility and midterm outcomes of iliac branch devices (IBD) for the treatment of aneurysmal distal seal zones after endovascular aneurysm repair (EVAR). METHODS: Between January 2005 and January 2014, 188 patients with aortic aneurysms involving the iliac bifurcation underwent IBD implantation; of these, 18 consecutive patients (17 men; mean age 70±10 years) were treated for aneurysmal degeneration of 22 distal seal zones (mean 36±6-mm diameter) after EVAR. The main outcome measure was technical success. Further outcomes were primary and assisted primary patency of the internal iliac branch, types Ib/III endoleaks, reintervention, and all-cause mortality. RESULTS: The technical success rate was 100%. The primary patency rate was 100% over a median follow-up of 15 months (interquartile range 4-25). None of the patients developed type Ib or III endoleak. During surveillance, two device-related reinterventions were performed (thrombectomy of an occluded external iliac artery and angioplasty with stenting of a stenotic common iliac artery). One patient died due to metastatic prostate cancer. CONCLUSION: Iliac side branch endografting showed excellent feasibility and encouraging midterm outcomes for the challenging endovascular repair of aneurysmal distal seal zones post EVAR.

Endovascular treatment as first line approach for infrarenal aortic occlusive disease.

INTRODUCTION: The purpose of this study was to report the early and late results of primary stenting for focal atherosclerotic lesions of the infrarenal aorta. METHODS: A retrospective analysis of 52 consecutive patients treated for infrarenal occlusive aortic disease with primary stenting between January 2002 and November 2009 was performed. Original angiographic imaging, medical records, and noninvasive testing were reviewed. Primary stenting was the first line of treatment. Perioperative technical success and Kaplan-Meier estimates for patency and survival were calculated. RESULTS: The majority of the patients (43) were treated for severe claudication (Rutherford III; 82.7%), 5 for ischemic rest pain (Rutherford IV; 9.6%), and 4 for minor tissue loss (Rutherford V; 7.7%). Aortic stenosis was found in 40 cases (76.9%) and occlusion in 12 (23%). Perioperative hemodynamic success was 100%. All patients had an improvement of ankle brachial index (ABI) >0.10. Clinical improvement was found in 96%. Early surgical revision was necessary for aortic rupture in 1 patient. One death occurred for pneumonia. The mean follow-up time was 39.4 ± 27.2 months. Ten reinterventions (19%) were needed for symptom recurrence. The estimated assisted primary patency at 9 years was 96% and the mean survival time was 86.6 months. CONCLUSION: Primary stenting offers safe and durable results and should be considered as the first line of treatment for focal aortic lesions.

Use of abdominal chimney grafts is feasible and safe: short-term results.

PURPOSE: To present our initial experience with the use of chimney grafts in endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs) with challenging anatomy. METHODS: Among 390 EVAR cases performed at our institution between November 2008 and February 2010, 15 patients (all men; mean age 81.8 years) underwent EVAR with synchronous placement of chimney grafts. The chimney technique involved placing covered stents parallel to the main aortic stent-graft to preserve or rescue flow to aortic branch vessels while extending the proximal fixation zone. All patients presented with pararenal aortic aneurysms with short necks (between 0 and 10 mm long) that required either suprarenal clamping to tailor a proximal anastomosis in open repair or suprarenal fixation to anchor an endoprosthesis. Chimney grafts were implanted into 10 left renal and 5 right renal arteries. RESULTS: The immediate technical success was 100%. One early type II endoleak due to retrograde flow from the inferior mesenteric artery was detected and is under surveillance. Mean follow-up was 6.8 months (range 1-13). One chimney graft occluded 45 days postoperatively; the patient underwent open thrombectomy of the left renal artery and iliorenal bypass. The creatinine value at discharge was 1.6 mg/dL, and resting renal scintigraphy showed 36% perfusion for the left kidney and 64% for the right kidney. During follow-up, no patient required hemodialysis; no aneurysm-related deaths were noted. CONCLUSION: This limited experience demonstrates that the use of abdominal chimney grafts is feasible and safe. Long-term results in larger patient cohorts are needed evaluate the utility of this alternative endovascular technique.

Below knee bare nitinol stent placement in high-risk patients with critical limb ischemia is still durable after 24 months of follow-up.

BACKGROUND: This study evaluated the durability of nitinol stent placement in high-risk patients with chronic critical limb ischemia (CLI) and infrapopliteal lesions after suboptimal balloon angioplasty. METHODS: Between January 2006 and January 2009, 53 high-risk patients (24 women; mean age, 71.8 +/- 5.1 years) with CLI underwent infragenicular stent placement with a 4F sheath-compatible self-expanding nitinol stent. Patients had three or more serious cardiopulmonary comorbidities, including chronic obstructive pulmonary disease, congestive heart failure, coronary artery occlusive disease, American Society of Anesthesiologists score >/=3, previous myocardial infarction, coronary stent or bypass, or infection after peripheral revascularization. Endovascular therapy was performed in 30 stenoses and 23 occlusions in 53 patients. The mean stenosis length was 5.5 +/- 1.9 cm. The mean occlusion length was 6.5 +/- 2.9 cm. The mean follow-up was 24.1 +/- 7.3 months and consisted of clinical examination, ankle-brachial index (ABI) measurements, and duplex ultrasound imaging. Digital subtraction angiography was performed if restenosis or reocclusion was suspected. RESULTS: The technical success rate was 98.1%. The 24-month cumulative primary patency rate was 75.5%. During the follow-up, two patients underwent successful repeat angioplasty, and four patients required crural bypass. The 24-month secondary patency and freedom from amputation rates were 88.7% and 88.7%, respectively. The mean ABI increased significantly at 12 and 24 months (P < .001). Risk stratification to detect predictors that influenced the patency rate showed that proximal lesions had significant better patency than distal crural lesions (83.3% vs 65.2%, P = .04). The morphology of the lesions (stenoses vs occlusions, P = .88) did not seem to influence primary patency. Four patients died from nonprocedure-related causes during the follow-up, including lung cancer, myocardial infarction, and glioblastoma multiforme. No procedure-related deaths were recorded. CONCLUSIONS: The 2-year outcome of our series underscores the value of infrapopliteal nitinol stent placement as a durable bailout treatment option in high-risk CLI patients with suboptimal angioplasty.

Endovascular treatment of internal iliac artery obstructive disease.

BACKGROUND: This study evaluated the therapeutic value of endovascular techniques in patients with buttock claudication caused by stenosis or occlusion of the internal iliac artery. METHODS: The records of patients with buttock claudication who had undergone endovascular treatment for internal iliac artery stenosis or occlusion were analyzed retrospectively, and any associated arterial lesions, morbidity, restenosis, or recurrent buttock claudication was noted. Outcomes were compared with published reports. Iliac artery duplex scans and aortoiliac angiography were performed to detect and confirm the internal iliac artery obstructive disease. The iliac duplex scanning surveillance protocol was set at 3, 6, and 12 months and yearly thereafter to detect eventual restenosis or occlusion. RESULTS: Between September 2006 and September 2008, 21 consecutive patients (19 men; mean age, 67 years) with 22 cases of buttock claudication (1 bilateral localization) underwent percutaneous transluminal angioplasty alone (14 cases) or additional stent placement in case of elastic recoil (8 cases). Buttock claudication was associated with impotence, thigh claudication, or calf claudication in seven patients. The endovascular approach was successful in all patients, without morbidity or mortality. During a mean follow-up of 14.7 +/- 5.7 months, 50% restenosis occurred in one 80-year-old patient. The patient had a pain-free walking distance of 110 meters and was treated conservatively. CONCLUSIONS: To our knowledge, the present study is the largest published report concerning endoluminal treatment of buttock claudication due to internal iliac artery obstructive disease. The midterm results are very encouraging and underscore the value of stent-supported angioplasty as first-line treatment. The procedure can be repeated should significant restenosis occur and does not compromise the option of surgical repair of the lesions.