Percutaneous intervention versus surgery in the treatment of common femoral artery lesions: study protocol for the prospective, multi-center, randomized PESTO-CFA trial.

BACKGROUND: Endovascular therapy has become established as a first-line therapy in most arterial regions. However, open vascular surgery (endarterectomy) remains the treatment of choice for common femoral artery (CFA) lesions. The aim of this study is to investigate the acute and mid-term results of directional atherectomy plus drug-coated balloon (DCB) in comparison to endarterectomy in treatment of de novo arteriosclerotic CFA lesions. METHODS: This prospective, randomized, multicenter non-inferiority study will enroll 306 participants with symptomatic (Rutherford category 1 to 5) de novo stenosis of the CFA including the bifurcation. Patients eligible for both treatment groups could be included in this 1:1 randomized trial. Primary efficacy endpoint is patency of the target lesion at 12 months defined as restenosis < 50% without the need of clinically driven target lesion revascularization (cdTLR). Primary safety endpoint is a combined endpoint including death, myocardial infarction, major or minor amputation of the target limb, and peri-procedural complications at 30 days. Secondary endpoints include primary patency of the target lesion at 6 and 24 months, secondary patency, cdTLR 6, 12, and 24 months, change in ankle-brachial index, and Rutherford-Becker class at 6, 12, and 24 months. Limb salvage, change in quality of life measured by Walking Impairment Questionnaire, and major adverse events including death, myocardial infarction, and minor or major amputation of the target limb will be determined at 6, 12, 24, and 36 months. DISCUSSION: Endovascular treatment of CFA lesions is still a matter of debate. Few studies compared modern endovascular therapy methods against the so-called gold standard surgical endarterectomy so far. Based on recent positive results, this study aims to confirm non-inferiority of a "leaving nothing behind" endovascular approach combining directional atherectomy and DCB compared to surgical therapy. TRIAL REGISTRATION: ClinicalTrials.gov NCT02517827.

Midterm outcomes of rotational atherectomy-assisted endovascular treatment of severe peripheral arterial disease.

OBJECTIVE: We evaluated the midterm results of atherectomy-assisted angioplasty for the treatment of femoropopliteal lesions and the identification of possible subgroups of patients with superior outcomes. METHODS: We conducted a single-center, physician-initiated, nonindustry-sponsored retrospective analysis of patients with Rutherford category ranging from II to V and de novo occlusive or stenotic lesions of the superficial femoral (SFA) and/or popliteal arteries treated with atherectomy-assisted angioplasty (Jetstream rotational atherectomy + drug-eluting ballooning). In cases of subintimal recanalization or patients without an SFA stamp, with previous ipsilateral bypass surgery, systemic coagulopathy, end-stage renal disease requiring hemodialysis, life expectancy of <12 months, and intolerance to aspirin, clopidogrel, and/or heparin were excluded. RESULTS: In a total of 103 enrolled patients, the median SFA and/or popliteal lesion length was 80 mm (interquartile range, 61.2 mm) with 73 lesions being occlusive (70.9%) and 84 (81.5%) classified as Fanelli calcification score 3 and 4. Technical success was met in 96.1% of cases (n = 99) at a median operative time of 108 minutes. Adjunctive stenting was needed in 10 patients (9.8%). At a median follow-up of 18.0 ± 10.8 months, Rutherford class clinical improvement was present in 77 patients (74.8%), and 7 patients (6.79%) presented target lesion occlusion needing reintervention in 6 cases (5.82%). The primary patency rates were 97% at 12 months and 83% at 24 months with secondary patency rates of 99% at 12 months and 91% at 24 months of follow-up. There were no significant differences when treating differently located lesions, diabetic vs nondiabetic patients, or comparing experienced vs nonexperienced operators. CONCLUSIONS: The use of rotational atherectomy and drug-eluting balloons for the treatment of severe femoropopliteal disease showed relatively low need for bailout stenting and good midterm primary patency rates. The influence of lesion location, diabetes mellitus, or operator experience did not show statistically different results in terms of patency. Longer term outcomes and comparative analysis are needed to consolidate further clinical evidence.

[Atherectomy with a Novel Device Offering Wider Options]. / Atherektomie mit einem neuen System, das noch mehr kann.

Catheter-based atherectomy has been discussed for some years, although the conclusions have been controversial. Recent study data did show the feasibility of multifunctional atherectomy devices for complex lesion morphologies, with moderate material use. This is then thus an alternative to bypass surgery, although a direct comparison is lacking.The results of the ByCross approval study were compared to technical and clinical data from various atherectomy systems in terms of range of indication, limitations as defined by the manufacturer, the success and complication rate and the instructions for use. As in many recent studies, a residual stenosis ≤ 50% after atherectomy and ≤ 30% in the completion imaging was defined as the primary endpoint and proof of technical success.Lesions recruited for the ByCross study were more complex than in other studies, with respect to the lesion length (124.7 mm vs. 34 mm in the EASE study and 67.2 mm in the VISION study) and the degree of stenosis (99.4% vs. 88.5% in the EASE and 78,7% in the VISION study). Calcification was also more severe - as defined by the PACSS (Peripheral Artery Calcification Severity Score). ByCross allowed recanalisation of lesions without wire passage prior to atherectomy (26.82%), which is a must for all other systems. The variable tip diameter of the ByCross can achieve a lumen gain of 4.7 mm without tip or wire exchange or run time limits. The 0% rate of embolic events, which is unique for atherectomy device approval studies, can be explained by the working principle and the high aspiration rate. No vessel injuries occurred, and the 6-month follow-up results showed 0% revascularisation rate.New generation atherectomy systems offer safe and effective enlargement of the endovascular portfolio. The ByCross device is an atherectomy, thrombectomy and crossing device free from investment and has a wider range of indications for the iliac and the femorodistal segments, which supports ByCross atherectomy as an alternative for bypass surgery.

Combination of RotarexⓇS Rotational Atherothrombectomy and Drug-Coated Balloonangioplasty for Femoropopliteal Total In-Stent Occlusion.

BACKGROUND: Currently, there is little information on the optimal treatment for patients with femoropopliteal total in-stent occlusion.The aim of this study was to evaluate the benefit of drug-coated balloon(DCB) angioplasty after RotarexⓇS rotational atherectomy plus thrombectomy for femoropopliteal total in-stent occlusion at 12 months. METHODS: From June 2016 to April 2019, 36 patients (21 male, mean age 71.1 ± 8.2 years) with femoropopliteal total in-stent occlusion were treated using Rotarex S rotational atherectomy plus thrombectomy in combination with DCB angioplasty and 29 (18 male, meanage68.8 ± 7.2 years) underwent DCB angioplasty alone. Primary patency and freedom from target lesion revascularization (TLR) rates during12 months of follow-up were retrospectively compared between the 2 groups. RESULTS: Procedural success was achieved in all patients. There were no procedure-related adverse events. The mean lesion length was 26.1 ± 6.5 cm in the combination therapy group and 25.5 ± 6.1 cm in the DCB only group (P = 0.703). The 6-month and 12-month primary patency rates were significantly higher in the combination therapy group (94.4% [standard error, 0.038] and 77.8% [0.069], respectively) than in the DCB only group (72.4% [0.083] and 48.3% [0.093]; P = 0.010). The freedom from TLR rate at 12 months was 86.1% (standard error, 0.060) in the combination therapy group and 62.1% (0.096) in the DCB only group (P = 0.016). Three patients (combination therapy, n = 2; DCB only, n = 1) developed distal embolization and were treated successfully by additional 6-F guiding catheter aspiration. No deaths or amputations occurred in either group during 12 months of follow-up. CONCLUSIONS: Rotarex S rotational atherectomy plus thrombectomyin combination with DCB was safe and effective in patients with femoropopliteal total in-stent occlusion during12 months of follow-up.

Critical appraisal of the contemporary use of atherectomy to treat femoropopliteal atherosclerotic disease.

OBJECTIVE: Atherectomy has become increasingly used as an endovascular treatment of lower extremity atherosclerotic disease in the United States. However, concerns and controversies about its indications and outcomes exist. The goal of the present systematic review and meta-analysis was to investigate the outcomes and complications related to atherectomy to treat femoropopliteal atherosclerotic disease. METHODS: A systematic review in accordance with the recommendations from the PRISMA (preferred reporting items for systematic reviews and meta-analyses) statement was performed. Four major scientific repositories (MEDLINE, Embase, the Cochrane Library, and Thompson Web of Sciences) were queried from their inception to April 5, 2020. We reviewed and entered the data in a dedicated dataset. The outcomes included the patency rates, clinical and hemodynamic improvement, and morbidity and mortality associated with atherectomy interventions. RESULTS: Twenty-four studies encompassing 1900 patients met the inclusion criteria for the present study. Of the 1900 patients, 74.3% had presented with Rutherford class 1 to 3 and 25.7% presented with Rutherford class 4 to 6; 1445 patients had undergone atherectomy, and 455 patients had been treated without atherectomy. The atherectomy group had undergone directional atherectomy (n = 851), rotational atherectomy (n = 851), laser atherectomy (n = 201), and orbital atherectomy (n = 78). Most of these patients had also received adjunct treatments, which varied across the studies and included a combination of stenting, balloon angioplasty, or drug-coated balloon angioplasty. Technical success was achieved in 92.3% of the cases. Distal embolization, vessel perforation, and dissection occurred in 3.4%, 1.9%, and 4% of the cases, respectively. The initial patency was 95.4%. At the 12-month median follow-up, the primary patency was 72.6%. The ankle brachial index had improved from a preoperative mean of 0.6 to a postoperative mean of 0.84. The incidence of major amputation and mortality during the follow-up period was 2.2% and 3.4%, respectively. CONCLUSIONS: The results from our review of the reported data suggest that femoropopliteal atherectomy can be completed safely, modestly improving the ankle brachial index and maintaining the 1-year patency in nearly three of four patients. However, these findings were based on heterogeneous studies that skewed the generalizable conclusions about atherectomy's efficacy. Atherectomy places a high cost burden on the healthcare system and is used in the United States at a higher rate than in other countries. Our review of the literature did not demonstrate clear atherectomy superiority to alternatives that would warrant the pervasive and increasing use of this costly technology. Future work should focus on developing high-quality randomized controlled trials to determine the specific patient and lesion characteristics for which atherectomy can add value.

Excimer laser atherectomy in complex peripheral artery disease: a prospective European registry.

BACKGROUND: This study aimed to investigate performance, effectiveness, and safety of excimer laser atherectomy for the treatment of complex lower limb artery disease in a real-world setting. METHODS: In our prospective, multicenter registry, consecutive patients with complex lower limb lesions underwent excimer laser atherectomy with optional standard balloon angioplasty, paclitaxel-coated balloon angioplasty, and bailout stenting. Primary outcome was technical success. Secondary outcomes were device performance of the excimer laser system, freedom from target lesion revascularization (TLR), peri-procedural complications, and amputation-free survival in patients with critical limb ischemia (CLI). RESULTS: A total of 294 patients were enrolled at 14 European centers (mean lesion length 109±103 mm, total occlusions 56.8% [167 of 294 lesions], CLI 47.3% [132 of 279 patients]. Adjuvant balloon angioplasty was conducted in 283 (96.3%), and complementary stent implantation in 98 patients (33.3%). Technical success was achieved in 95.3% of patients. Increasing lesion length was associated with decreased laser atherectomy performance (odds ratio [OR] per 10 mm: 0.94 [95% confidence interval [CI] 0.90 to 0.99], P=0.01). A total of 66 patients (22.4%) completed the 12-month follow-up. Freedom from TLR was 83.5% (95% CI: 74.9 to 92.1) at 12 months. Chronic total occlusions were associated with more TLR (OR 5.03 [95% CI: 1.01 to 25.1], P=0.049). Amputation -free survival in patients with CLI was 93.1% (95% CI: 83.9 to 100). CONCLUSIONS: Excimer laser atherectomy substantially contributed to technical success of endovascular treatment of complex infra-inguinal lesions. Freedom from 12-month TLR was reasonable.

Outcomes of rotational atherectomy in complex lesions of the superficial femoral artery.

BACKGROUND: The effectiveness of rotational atherectomy in the treatment of complex superficial femoral artery (SFA) lesions remains poorly defined. Outcomes of SFA lesions treated with rotational atherectomy were analyzed. METHODS: This retrospective review assessed all patients who underwent rotational atherectomy of the SFA at a single institution between 2015 and 2018. The data of all patients were deidentified, and the study was approved by the Institutional Review Board. Informed consent was not obtained for this retrospective analysis. Main outcomes were Kaplan-Meier primary patency rate, freedom from major amputation, and 2-year survival rate. The effect of drug-coated balloon angioplasty (DCBA) on patency and time to death was investigated with univariate regression. The safety profile for atherectomy and DCBA was assessed by the 30-day incidence of major amputation and all-cause mortality. RESULTS: Fifty-three patients (mean age, 70.2 ± 9.8 years; 73% male; 65% critical limb-threatening ischemia; 47 [90%] current or former smokers; seven [13%] with prior failed ipsilateral endovascular intervention) underwent rotational atherectomy (Jetstream; Boston Scientific, Marlborough, Mass) with mean follow-up of 543 days. Forty-six (87%) patients underwent DCBA (Lutonix; BD Bard, Covington, Ga) after atherectomy. Mean lesion length was 13.2 ± 9.0 cm. Thirty-one (58%) lesions were TransAtlantic Inter-Society Consensus C or D class. At 1-month follow-up, 39 of 45 (87%) patients experienced improvement in symptoms and Rutherford class. An improvement in ankle-brachial index was also noted in 13% of patients without improvement of symptoms, with no patients progressing to surgical bypass or major amputation. Mean ankle-brachial index increased from 0.54 ± 0.035 to 0.90 ± 0.031 at 1 month after intervention (P < .001) and remained constant out to 18 months. Mean toe pressure increased from 36 ± 3.8 mm Hg to 67 ± 4.5 mm Hg at 1 month after intervention (P < .001) and remained constant out to 18 months. Kaplan-Meier primary patency rate was 75% (95% confidence interval, 61%-85%) at 12 months and 65% (51%-77%) at 24 months. There was a trend toward improved primary patency after adjunctive DCBA compared with plain balloon angioplasty at 1 year (75% vs 43%; P = .1082). There was no significant difference in mortality between adjunctive DCBA and plain balloon angioplasty at 2 years (11% vs 0%). The 2-year incidence of major amputation in critical limb-threatening ischemia patients was 3.9% (1.2%-6.5%). One patient died and none underwent amputation within 30 days. CONCLUSIONS: Rotational atherectomy with adjunctive DCBA of long SFA lesions has excellent long-term patency. Two-year major amputation and mortality rates are low, and the technique has an exceptional safety profile.

Atherectomy for peripheral arterial disease.

BACKGROUND: Symptomatic peripheral arterial disease (PAD) has several treatment options, including angioplasty, stenting, exercise therapy, and bypass surgery. Atherectomy is an alternative procedure, in which atheroma is cut or ground away within the artery. This is the first update of a Cochrane Review published in 2014. OBJECTIVES: To evaluate the effectiveness of atherectomy for peripheral arterial disease compared to other established treatments. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Allied and Complementary Medicine (AMED) databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 12 August 2019. SELECTION CRITERIA: We included all randomised controlled trials that compared atherectomy with other established treatments. All participants had symptomatic PAD with either claudication or critical limb ischaemia and evidence of lower limb arterial disease. DATA COLLECTION AND ANALYSIS: Two review authors screened studies for inclusion, extracted data, assessed risk of bias and used GRADE criteria to assess the certainty of the evidence. We resolved any disagreements through discussion. Outcomes of interest were: primary patency (at six and 12 months), all-cause mortality, fatal and non-fatal cardiovascular events, initial technical failure rates, target vessel revascularisation rates (TVR; at six and 12 months); and complications. MAIN RESULTS: We included seven studies, with a total of 527 participants and 581 treated lesions. We found two comparisons: atherectomy versus balloon angioplasty (BA) and atherectomy versus BA with primary stenting. No studies compared atherectomy with bypass surgery. Overall, the evidence from this review was of very low certainty, due to a high risk of bias, imprecision and inconsistency. Six studies (372 participants, 427 treated lesions) compared atherectomy versus BA. We found no clear difference between atherectomy and BA for the primary outcomes: six-month primary patency rates (risk ratio (RR) 1.06, 95% confidence interval (CI) 0.94 to 1.20; 3 studies, 186 participants; very low-certainty evidence); 12-month primary patency rates (RR 1.20, 95% CI 0.78 to 1.84; 2 studies, 149 participants; very low-certainty evidence) or mortality rates (RR 0.50, 95% CI 0.10 to 2.66, 3 studies, 210 participants, very low-certainty evidence). One study reported cardiac failure and acute coronary syndrome as causes of death at 24 months but it was unclear which arm the participants belonged to, and one study reported no cardiovascular events. There was no clear difference when examining: initial technical failure rates (RR 0.48, 95% CI 0.22 to 1.08; 6 studies, 425 treated vessels; very low-certainty evidence), six-month TVR (RR 0.51, 95% CI 0.06 to 4.42; 2 studies, 136 treated vessels; very low-certainty evidence) or 12-month TVR (RR 0.59, 95% CI 0.25 to 1.42; 3 studies, 176 treated vessels; very low-certainty evidence). All six studies reported complication rates (RR 0.69, 95% CI 0.28 to 1.68; 6 studies, 387 participants; very low-certainty evidence) and embolisation events (RR 2.51, 95% CI 0.64 to 9.80; 6 studies, 387 participants; very low-certainty evidence). Atherectomy may be less likely to cause dissection (RR 0.28, 95% CI 0.14 to 0.54; 4 studies, 290 participants; very low-certainty evidence) and may be associated with a reduction in bailout stenting (RR 0.26, 95% CI 0.09 to 0.74; 4 studies, 315 treated vessels; very low-certainty evidence). Four studies reported amputation rates, with only one amputation event recorded in a BA participant. We used subgroup analysis to compare the effect of plain balloons/stents and drug-eluting balloons/stents, but did not detect any differences between the subgroups. One study (155 participants, 155 treated lesions) compared atherectomy versus BA and primary stenting, so comparison was extremely limited and subject to imprecision. This study did not report primary patency. The study reported one death (RR 0.38, 95% CI 0.04 to 3.23; 155 participants; very low-certainty evidence) and three complication events (RR 7.04, 95% CI 0.80 to 62.23; 155 participants; very low-certainty evidence) in a very small data set, making conclusions unreliable. We found no clear difference between the treatment arms in cardiovascular events (RR 0.38, 95% CI 0.04 to 3.23; 155 participants; very low-certainty evidence). This study found no initial technical failure events, and TVR rates at six and 24 months showed little difference between treatment arms (RR 2.27, 95% CI 0.95 to 5.46; 155 participants; very low-certainty evidence and RR 2.05, 95% CI 0.96 to 4.37; 155 participants; very low-certainty evidence, respectively). AUTHORS' CONCLUSIONS: This review update shows that the evidence is very uncertain about the effect of atherectomy on patency, mortality and cardiovascular event rates compared to plain balloon angioplasty, with or without stenting. We detected no clear differences in initial technical failure rates or TVR, but there may be reduced dissection and bailout stenting after atherectomy although this is uncertain. Included studies were small, heterogenous and at high risk of bias. Larger studies powered to detect clinically meaningful, patient-centred outcomes are required.

Outcomes of atherectomy for lower extremity ischemia in an office endovascular center.

OBJECTIVE: To evaluate the safety and effectiveness of infrainguinal artery revascularization via atherectomy supplemented with other endovascular techniques in an office endovascular center (OEC) setting. METHODS: A retrospective study was conducted examining 352 lower extremity atherectomy revascularization procedures between 2011 and 2016 at an OEC by five board-certified vascular surgeons. Patients received laser atherectomy or orbital atherectomy followed by angioplasty or angioplasty and stent placement as needed. Reintervention was indicated based on evidence of clinical symptoms and imaging studies. Demographics, vessel-specific data, treatment information, and outcome of procedures were recorded. Data analysis was carried out using Kaplan-Meier survival curves. RESULTS: Lower extremity atherectomy was carried out in 282 patients in 352 limbs with average age of 69 ± 11 years. Technical success of <30% residual stenosis by angiogram was achieved in 571/594 vessels treated. Within 30 days of procedure, 23/352 limbs required major amputation resulting from pre-existing disease, ranging from 3 Rutherford class 4, 17 Rutherford class 5, to 3 Rutherford class 6 limbs. No 30-day mortality was noted. The primary patency of the 571 treated vessels at 12 months was 90%, and 84% at 29 months. The patency of treated vessels that reached >50% stenosis on follow-up and required reintervention (51/571 vessels) or did not require reintervention (79/571) was 72% and 87% at 23 months' follow-up, respectively, with no difference in risk of occlusion identified (P = .181). There was a significantly increased risk of occlusion for vessels treated with laser atherectomy as compared with orbital atherectomy (odds ratio, 2.552; 95% confidence interval, 1.375-4.735; P = .003). No significant difference in risk of occlusion was found between treatment with atherectomy and angioplasty (466/571 vessels) compared with atherectomy, angioplasty, and stenting (102/571) with secondary patency of 90% and 85% at 6 months' follow-up, respectively. There was no difference in patency between claudicants and patients with critical limb ischemia. CONCLUSIONS: Atherectomy in conjunction with angioplasty and/or stenting has satisfactory patency with minimal complications when the procedure is carried out in an OEC. Asymptomatic >50% restenosis of treated vessels does not warrant reintervention unless the patient presents with clinical symptoms. Various atherectomy devices may result in different outcomes.

Impact of office-based laboratories on physician practice patterns and outcomes after percutaneous vascular interventions for peripheral artery disease.

BACKGROUND: Percutaneous vascular interventions (PVIs) for peripheral artery disease have shifted from hospital-based facilities to office-based laboratories (OBLs). The transition to OBLs is due to a variety of factors such as technology advancement, increased efficiency, and financial incentives. We evaluated the impact of physicians switching to OBLs use from hospital-based facilities on procedure volume, procedure type, and patient outcomes. METHODS: We identified patients with PVI for lower extremity peripheral artery disease from 2006 to 2013 in a 20% Medicare sample and identified physicians who transitioned from predominantly hospital-based facilities to OBLs (switch physicians) and compared them with those who did not use OBLs (control physicians). The main outcomes investigated were average number of PVIs at 30 days and 1 year and atherectomy usage. Patient outcomes included above-ankle amputation, major adverse limb events, and death. We used a difference-in-difference model to control for time effects in a multivariate regression model, reported as an odds ratio (OR) and 95% confidence interval (CI). RESULTS: The cohort comprised 292 switch physicians, who treated 7134 patients (3888 before OBL use and 3246 after transitioning to OBLs), and 3715 control physicians treating 54,213 patients (36,327 in the preperiod and 17,886 in the postperiod). Switch and control physicians both treated more patients with lower extremity wounds during the study period; however, this increase was greater for control physician (0.7% vs 5.5%, P < .001). On average, patients treated by switch physicians had 0.05 (95% CI, 0.03-0.07; P < .001) underwent more PVIs within 30 days and 0.12 more PVIs (95% CI, 0.08-0.16; P < .001) within 1 year of the initial revascularization procedure after the physician transitioned to an OBL. Similarly, patients treated by switch physicians underwent 0.02 (95% CI, 0.01-0.03; P = .002) more atherectomy procedures at 30 days and 0.03 (95% CI, 0.01-0.05; P = .008) more atherectomy procedures at 1 year. Transitioning to OBLs was also associated with a decreased risk in above-ankle amputation at 30 days (OR, 0.58; 95% CI, 0.38-0.97; P = .009) and 1 year (OR, 0.75; 95% CI, 0.60-0.95; P = .01). However, no statistical difference was observed for major adverse limb events and mortality rates at 30 days and 1 year because patients treated by switch and control physicians experienced similar decreases. CONCLUSIONS: Transitioning to OBLs was associated higher 30-day and 1-year PVI rates and atherectomy rates. Although transitioning to OBLs was associated with lower rates of above-ankle amputations, switch physicians treated a lower number of patients with lower extremity wounds.

Optical Coherence Tomography Evaluation of Superficial Femoral Artery Directional Atherectomy.

To the best of our knowledge, this is the first report of optical coherence tomography evaluation of superficial femoral artery atherectomy in a patient from the Asia-Pacific region. We demonstrate the feasibility of this technique in Chinese populations.

Usefulness of Atherectomy in Chronic Total Occlusion Interventions (from the PROGRESS-CTO Registry).

There is limited data on the use of atherectomy during chronic total occlusion (CTO) percutaneous coronary intervention (PCI). We compared the clinical and procedural characteristics and outcomes of CTO PCIs performed with or without atherectomy in a contemporary multicenter CTO PCI registry. Between 2012 and 2018, 3,607 CTO PCIs were performed at 21 participating centers. Atherectomy was used in 117 (3.2%) cases: rotational atherectomy in 105 cases, orbital atherectomy in 8, and both in 4 cases. Patients in whom atherectomy was used, were older (68 ± 8 vs 64 ± 10 years, p <0.0001) and had higher Japan-chronic total occlusion score (3.0 ± 1.2 vs 2.4 ± 1.3, p <0.0001). CTO PCI cases in which atherectomy was used had similar technical (91% vs 87%, p = 0.240) and procedural (90% vs 85%, p = 0.159) success and in-hospital major adverse cardiac event (4% vs 3%, p = 0.382) rates. However, atherectomy cases were associated with higher rates of donor vessel injury (4% vs 1%, p = 0.031), tamponade requiring pericardiocentesis (2.6% vs 0.4%, p = 0.012) and more often required use of a left ventricular assist device (9% vs 5%, p = 0.031). Atherectomy cases were associated with longer procedural duration (196 [141, 247] vs 119 [76, 180] minutes, p <0.0001), and higher patient air kerma radiation dose (3.6 [2.5, 5.6] vs 2.8 [1.6, 4.7] Gray, p = 0.001). In conclusion, atherectomy is currently performed in approximately 3% of CTO PCI cases and is associated with similar technical and procedural success and overall major adverse cardiac event rates, but higher risk for donor vessel injury and tamponade.

Percutaneous endovascular tissue sampling of endoluminal tumors using directional atherectomy.

OBJECTIVES: To evaluate technical feasibility and safety of endovascular tumor specimen sampling using an escalating endovascular biopsy strategy using a directional atherectomy device compared with forceps biopsy and catheter aspiration. MATERIALS AND METHODS: Between 2013 and 2017, a cohort of ten consecutive patients (6 male; median age 56, range 39-73 years) was referred for sampling of endovascular masses. Localizations included the abdominal aorta (n = 4), left brachiocephalic vein (n = 2), inferior vena cava (n = 1), and left pulmonary artery (n = 3). For each individual mass, all three endovascular tissue sampling approaches were applied including catheter-based aspiration, straight two-jaw biopsy forceps, and directional atherectomy during a single session. RESULTS: Aspiration and forceps biopsy did not provide sufficient material for histological analyses. In contrast, technical success for endovascular tumor sampling using directional atherectomy was 100%. After two atherectomy passages, sufficient material was available for each vessel region allowing histologic diagnosis, which revealed sarcoma and chronic inflammation for masses in the aorta, angiosarcoma for brachiocephalic vein, hepatocellular carcinoma for inferior vena cava, and angiosarcoma for pulmonary artery. In case of a histologically benign diagnosis, no malignant tumor proliferation was obvious on follow-up imaging studies after 3 months and 1 year. Thus, the rate of false-negative results was considered 0%. No procedure-associated complications, e.g., vessel perforation, were recorded. CONCLUSION: Preliminary results in a limited number of patients proved directional atherectomy beneficial as a safe and feasible technique for endoluminal tissue sampling of vascular masses. Additional large-scale studies are necessary and worthy for further evaluation in clinical practice. KEY POINTS: • Endovascular masses pose a challenge to appropriate clinical management. • Off-label directional atherectomy proved to be a safe and feasible technique for endoluminal tissue sampling of vascular masses. Furthermore, directional atherectomy was superior to aspiration or forceps biopsy in our small study cohort. • Directional atherectomy may represent the last or only option for tissue probing as a prerequisite for further treatment decisions.

Orbital atherectomy for calcified femoropopliteal lesions: a current review.

The orbital atherectomy system is a novel form of atherectomy that uses orbital sanding and pulsatile forces, an effective method of treatment for peripheral atherosclerotic lesions with varying levels of occlusion. Although the devices only has a general indication from the FDA to treat atherosclerotic lesions, they are effective in treating all kinds of lesions, and can therefore mitigate effects of all severities of peripheral artery disease. This approach to endovascular therapy involves the use of differential sanding to preferentially ablate fibrous, fibrofatty and calcified lesions, while deflecting healthy intima away from the crown. The eccentrically mounted crown design allows the device to employ rhythmic pulsating forces that penetrate the medial layer, and cause cracking in the lesions in order to facilitate easier balloon inflation and intravascular drug elution. The combination of vessel modification and lumen enlargement through sanding can effectively restore blood flow to the extremities, and can eliminate risk of critical limb ischemia, as well as subsequent amputation. Extensive lab testing and clinical trials have confirmed the high success rates and low major adverse events associated with this form of treatment. The device is economically viable as well, since its cost is offset by the lower frequency of adjunctive therapy sessions when compared to other devices. Considering the results outlined in this manuscript, the Diamondback 360° is an effective form of atherectomy therapy for peripheral artery disease. In-depth understanding of the operation preparation, procedure, and best imaging techniques can help to optimize outcomes.

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.

Hybrid atherectomy for lower extremity peripheral arterial disease.

OBJECTIVE: To evaluate the effectiveness of directional atherectomy with a Phoenix atherectomy system in lower extremity peripheral arterial disease (LE-PAD). MATERIALS AND METHODS: A retrospective review of subjects who had undergone atherectomy for severe and occluded LE-PAD. Demographic data, procedural properties, and follow-up information were recorded. The technical, procedural and clinical successes were reported. RESULTS: In total, 120 subjects were evaluated. The superficial femoral artery (SFA) group consisted of 64 subjects (53.3%), and the popliteal group consisted of 56 (46.7%) subjects. Groups did not differ in terms of age, gender, comorbid diseases and tobacco use. In both groups, four subjects (6.3% of SFA and 7.1% of the popliteal group) experienced extravasation was encountered in from the vessel during the procedure. During atherectomy, two (3.3%) of the subjects in the SFA group and one (1.9%) subject in the popliteal group experienced vessel dissection. Acute technical success in this study was 96.7% for SFA and 98.1% for the popliteal group. Overall technical success was 97.7%. In the first 72 h, three (5%) of the subjects in the SFA group and four (7.7%) of the subjects in the popliteal group experienced major adverse events. Acute procedural success in this study was 91.7% for SFA and 90.4% for the popliteal group. Overall procedural success was 91.1%. Success was defined as an improvement of at least one grade in the Rutherford classification; two (3.3%) subjects did not demonstrate improvements in the SFA group, and the clinical success rate was 96.7%. All subjects in the popliteal group demonstrated an improvement of at least one grade in the Rutherford classification, and clinical success was 100%. When the groups combined all subjects, the clinical success in this study was 98.2%. CONCLUSION: Directional atherectomy with a Phoenix atherectomy system demonstrated comparable results with the literature.

Clinical outcomes of atherectomy prior to percutaneous coronary intervention: A comparison of outcomes following rotational versus orbital atherectomy (COAP-PCI study).

BACKGROUND: Because of the challenges in treating calcified coronary artery disease (CAD), lesion preparation has become increasingly important prior to percutaneous coronary intervention (PCI). Despite growing data for both rotational atherectomy (RA) and orbital atherectomy (OA), there have been no multicenter studies comparing the safety and efficacy of both. We sought to examine the clinical outcomes of patients with calcified CAD who underwent atherectomy. METHODS: A total of 39 870 patients from five tertiary care hospitals who had PCI from January 2011 to January 2017 were identified. 907 patients who had RA or OA were included. This multicenter, prospectively collected observational analysis compared OA and RA. The primary end-point was myocardial infarction and safety outcomes including significant dissection, perforation, cardiac tamponade, and vascular complications. Propensity score matching (1:1) was performed to reduce selection bias. RESULTS: After matching, 546 patients were included in the final analysis. The primary endpoint, myocardial infarction occurred less frequently with OA compared to RA (6.7% vs 13.8%, P ≤ 0.01) in propensity score matched cohorts. Procedural safety outcomes were comparable between the groups. The secondary outcome of death on discharge occurred less in the OA group as compared with RA (0% vs 2.2%, P = 0.01). Fluoroscopy time was less in patients who were treated with OA (21.9 vs 25.6 min, P ≤ 0.01). Additional secondary outcomes were comparable between groups. CONCLUSION: In this non-randomized, multicenter comparison of contemporary atherectomy devices, OA was associated with significantly decreased in-hospital myocardial infarction and mortality after propensity score matching with decreased fluoroscopy time.

Directional Atherectomy Is Associated with Better Long-Term Efficiency Compared with Angioplasty for Common Femoral Artery Occlusive Disease in Rutherford 2-4 Patients.

BACKGROUND: Despite increased interest in treating common femoral artery (CFA) with endovascular technology, there are little data regarding the long-term outcomes of different endovascular treatment modalities. We report the results after endovascular therapy of symptomatic obstructions of the CFA in a single center. METHODS: We retrospectively reviewed the records of consecutive patients with eligible CFA lesions who were treated with endovascular methods between 2011 and 2013. The preoperative demographic operative details and postoperative outcomes were compared and statistically analyzed. RESULTS: Ninety patients with CFA lesions were treated, and 76 (84.4%) completed a follow-up. Claudication was present in 62 of 76 (81.6%) patients, and stenosis was present in 60 of 76 (78.9%) patients. Angioplasty was performed in 45 patients, and atherectomy was performed in 31 patients. There was no significant difference in the preoperative demographic data, procedure time, contrast administration, or length of hospital stay between the 2 groups. In-hospital treatment costs were significantly higher in the atherectomy group (69,822 RenMinBi Yuan vs. 49,078 RenMinBi Yuan; P = 0.043). During the 4-year primary patency, for whole group or bifurcated/claudicant subgroup, all patients within the atherectomy group were significantly better than those in the angioplasty group. CONCLUSIONS: Atherectomy may be a better alternative to angioplasty for CFA atherosclerotic obstructions lesions. Compared with angioplasty, atherectomy seems to have better results in bifurcated lesions or claudicant patients. In diabetic patients, no superiority was found on either patency or improvement in walking distance.