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.

Outcomes of endovascular intervention for atherosclerotic lesions confined to the popliteal artery.

OBJECTIVE: Most surgeons employ an endovascular-first approach to the treatment of peripheral arterial disease (PAD), but controversy remains regarding the ideal interventions for the management of isolated popliteal artery disease (IPAD). Indeed, there are a paucity of data that compare outcomes of popliteal stents vs other peripheral vascular interventions (PVIs). The goal of this study was to evaluate outcomes of PVIs in IPAD. METHODS: The Vascular Study Group of New England database was queried for all IPAD PVIs performed for atherosclerotic occlusive disease from 2010 to 2021. Those with at least 1 year of follow-up data available were included for analysis. The primary endpoint was 1-year freedom from a composite target lesion (TL) treatment failure that included restenosis >50% on duplex, reintervention, or ipsilateral major amputation. RESULTS: We included 689 procedures performed on 634 patients. Of these, 250 (36.3%) were treated with plain balloons (POBA), 215 (31.2%) had stents, 170 (24.7%) had special balloons (drug-coated, cutting, or lithotripsy), and 54 (7.8%) atherectomies were performed. Stent placement was associated with lower freedom from TL treatment failure (72.6%) than special balloon (81.2%; P = .048) and atherectomy (88.9%; P = .012), but not POBA (76.8%; P = .293). On multivariable logistic regression, stents (odds ratio, 0.637; P = .021) and preoperative P2Y12 inhibitor therapy (odds ratio, 0.683; P = .048) were both associated with lower freedom from intervention failure. CONCLUSIONS: Popliteal stent placement is associated with a higher rate of TL treatment failure at 1 year when compared with other PVIs including special balloon angioplasty and atherectomy, but not POBA, and should therefore be avoided in favor of special balloons or atherectomy whenever feasible.

Solid state, pulsed-wave 355 nm UV laser atherectomy debulking in the treatment of infrainguinal peripheral arterial disease: The Pathfinder Registry.

BACKGROUND: Atherectomy is an important option for debulking atherosclerotic plaque from diseased arteries in patients with infrainguinal arterial disease. Laser atherectomy uses a high-powered laser to remove the plaque from the arteries to restore blood flow. AIMS: The Pathfinder multicenter registry was initiated to evaluate the safety and efficacy of the 355 nm laser atherectomy system in a real-world setting for the treatment of de novo, re-stenotic and in-stent restenosis (ISR) lesions in infrainguinal arteries of patients with peripheral artery disease (PAD). METHODS: The study was a prospective, single-arm, multicenter, open-label registry study for patients treated with the 355 nm laser system. Clinical and lesion characteristics, procedural safety and efficacy data, and baseline, 6-, and 12-month outcomes data, including Ankle Brachial Index (ABI), Rutherford class, and Walking Impairment Questionnaires (WIQ), were collected. The primary efficacy endpoint was the achievement of ≤30% final residual stenosis at the index lesion postatherectomy and adjunctive therapy evaluated by an angiographic Core Lab. The primary safety endpoint was the percentage of subjects who did not experience periprocedural major adverse events (PPMAEs) before discharge. RESULTS: One hundred and two subjects with 121 lesions treated with the 355 nm laser device at 10 centers were included in the analysis. Mean age was 68.4 ± 10.21 years, 61.8% of subjects were male, 44.6% had critical limb ischemia (CLI), and 47.3% had tibial lesions. The mean residual stenosis at the end of the procedure was 24.4 ± 15.5 with 69 lesions (69.0%) achieving technical procedural success (<30% stenosis); similar rates were observed for subjects with ISR (25.5 ± 14.9), chronic total occlusion (CTO) (28.1 ± 17.0), and severe calcification (36.5 ± 21.6) lesions. Mean ABI, Rutherford, and WIQ scores were improved at both 6 and 12 months. Ninety-seven of 102 subjects (95.1%) met the primary safety endpoint of not experiencing a PPMAE before discharge. CONCLUSIONS: The initial data from the Pathfinder Registry demonstrates the 355 nm laser system is safe and effective in a real-world setting for performing atherectomy in patients with infrainguinal PAD.

Comparison of mid-outcome among bare metal stent, atherectomy with or without drug-coated balloon angioplasty for femoropopliteal arterial occlusion.

This study evaluated the outcomes of a bare metal stent (BMS), DCB alone, atherectomy plus a drug-coated balloon (AT + DCB) and AT alone for the treatment of femoropopliteal artery occlusion. Four groups were included in this retrospective cohort study: 119 patients underwent the BMS procedure, 89 patients underwent DCB alone, 52 patients underwent AT + DCB, and 61 patients underwent AT alone. Patients were followed-up at 1, 6, 12 and 24 months after the procedure, the clinical outcomes and complications were assessed, and the primary outcomes were primary patency and restenosis. AT + DCB showed a lower bailout stent, and BMS displayed a higher retrograde puncture, flow-limiting dissection and postdilation (p < 0.05). For all procedures, the walking distance, ABI and pain score post-procedure were significantly improved compared with the pre-procedure values (p < 0.001). The restenosis rate was higher in BMS (21.0%) and AT alone (24.6%) than in DCB (10.1%) alone and AT + DCB (11.5%) (p = 0.04); there was no difference in amputation or clinically driven target lesion revascularization among procedures. The primary patency rates were 77.7%, 89.4%, 88.0% and 73.7% in the BMS, DCB alone, AT + DCB and AT alone groups at 24 months, respectively (p = 0.03), while the secondary patency and main adverse events (stroke, MI and death) were similar. Proximal concavity, proximal target vessel diameter ≥ 5 mm, runoff number ≥ 2 and DCB use were protective factors for primary patency. Our results suggested that AT + DCB and DCB alone were associated with higher primary patency, and DCB devices (combined with/without AT) should be the preferred choice for FP lesions.

Effects of atherectomy on major adverse limb events for femoropopliteal interventions: Vascular Quality Initiative registry.

BACKGROUND: Atherectomy use in treatment of femoropopliteal disease has significantly increased despite scant evidence of benefit to long-term clinical outcomes. AIMS: We investigated the clinical benefits of atherectomy over standard treatment for femoropopliteal interventions. METHODS: Using data from the Society of Vascular Surgery's Vascular Quality Initiative (VQI) registry, we identified patients who underwent isolated femoropopliteal interventions for occlusive disease. We compared 13,423 patients treated with atherectomy with 47,371 receiving standard treatment; both groups were allowed definitive treatment with a drug-coated balloon or stenting. The primary endpoint was major adverse limb events (MALEs), which is a composite of target vessel re-occlusion, ipsilateral major amputation, and target vessel revascularization. RESULTS: Mean age was 69 ± 11 years, and patients were followed for a median of 30 months. Overall rates of complications were slightly higher in the atherectomy group than the standard treatment group (6.2% vs. 5.9%, p < 0.0001). In multivariable analysis, after adjusting for demographic and clinical covariates, atherectomy use was associated with a 13% reduction in risk of MALEs (adjusted odds ratio [aOR]: 0.87; 95% confidence interval [CI]: 0.77-0.98). Rates of major and minor amputations were significantly lower in the atherectomy group (3.2% vs. 4.6% and 3.3% vs. 4.3%, respectively, both p < 0.001), primarily driven by a significantly decreased risk of major amputations (aOR 0.69; 95% CI: 0.52-0.91). There were no differences in 30-day mortality, primary patency, and target vessel revascularization between the atherectomy and standard treatment groups. CONCLUSIONS: In adults undergoing femoropopliteal interventions, the use of atherectomy was associated with a reduction in MALEs compared with standard treatment.

JETWING technique: Combination therapy of JETSTREAMⓇ and aggressive wire recanalization in calcified atheroma and dilatation technique for eccentric heavy calcified plaques using WINGMAN for insertion of protection wire.

Although endovascular treatment (EVT) has developed and still progressing, calcified lesions remain a big challenge to operators in obtaining good results. Whenever, the eccentric and calcified plaques or nodules are present, balloon dilatation may be difficult and vascular complications may frequently occur. We present a 73-year-old woman, with severe, eccentric, calcified lesion in the right superficial femoral artery (SFA). First, we performed the aggressive wire recanalization in calcified atheroma and dilatation (ARCADIA) technique for the eccentric plaques. Then, we used a WingmanⓇ crossing catheter (ReFlow Medical, Inc.) to penetrate and pass through the calcifications and eventually exchanged to a ParachuteⓇ (Good Care, Inc.) filter wire. Finally, we performed rotational atherectomy using the JETSTREAMⓇ (Boston Scientific) rotational atherectomy device for debulking to obtain good lesion expansion and was able to avoid potential complications. Performing ARCADIA technique then using a Wingman catheter for inserting a filter wire before JETSTREAMⓇ atherectomy is safe and effective for heavily calcified, eccentric lesions. Further studies will be needed to validate the safety and efficacy of this approach.

Safety and Efficacy of Excimer Laser Atherectomy Combined with a Drug-Coated Balloon in De Novo Femoral Popliteal Artery Disease: A Retrospective Study.

BACKGROUND: The effectiveness of excimer laser atherectomy (ELA) combined with drug-coated balloon (DCB) for de novo femoropopliteal artery disease (FPAD) is currently unknown. This case series evaluated the clinical outcomes of ELA combined with DCB in de novo FPAD from a real-world clinical perspective. METHODS: We conducted a retrospective study of patients treated with ELA + DCB for de novo FPAD between November 2016 and January 2020. The primary efficacy endpoint was the initial patency rate; secondary endpoints included target lesion revascularization without clinically driven target lesion revascularization (CD-TLR) and technical success. Primary safety endpoints included all-cause death, unplanned major amputation, and postoperative complications. RESULTS: The mean follow-up was 37.8 ± 25.3 months and included 56 consecutive patients (68.23 ± 8.01 years, 41 men). Forty-three patients had lifestyle-restricted claudication, and 13 patients had critical limb-threatening ischemia. The mean length of the lesion was 178.41 mm in all patients. The total lesion occlusion rate was 48.2 (n = 27), and the overall technical success rate was 100%. The 12-month, 24-month, 36-month, and 48-month primary patency rates of the ELA + DCB group were 75%, 66.1%, 58.9%, and 42.8%, respectively. Freedom from CD-TLR at 12, 24, 36, and 48 months was 83.9%, 80.3%, 76.8%, and 57.1%, respectively. CONCLUSIONS: In real-world clinical practice, ELA + DCB appears to be a safe and effective endovascular treatment for de novo FPAD, with a low rate of freedom from CD-TLR and a good patency rate.

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.

Outcomes of atherectomy in patients undergoing lower extremity revascularisation.

BACKGROUND: There is a paucity of real-world data on the in-hospital (IH) and post-discharge outcomes in patients undergoing lower extremity peripheral vascular intervention (PVI) with adjunctive atherectomy. AIMS: In this retrospective, registry-based study, we evaluated IH and post-discharge outcomes among patients undergoing PVI, treated with or without atherectomy, in the National Cardiovascular Data Registry PVI Registry. METHODS: The IH composite endpoint included procedural complications, bleeding or thrombosis. The primary out-of-hospital endpoint was major amputation at 1 year. Secondary endpoints included repeat endovascular or surgical revascularisation and death. Multivariable regression was used to identify predictors of atherectomy use and its association with clinical endpoints. RESULTS: A total of 30,847 patients underwent PVI from 2014 to 2019, including 10,971 (35.6%) treated with atherectomy. The unadjusted rate of the IH endpoint occurred in 524 (4.8%) of the procedures involving atherectomy and 1,041 (5.3%) of non-atherectomy procedures (p=0.07). After adjustment, the use of atherectomy was not associated with an increased risk of the combined IH endpoint (p=0.68). In the 6,889 (22.4%) patients with out-of-hospital data, atherectomy was associated with a reduced risk of amputation (adjusted hazard ratio [aHR] 0.67, 95% confidence interval [CI]: 0.51-0.85; p<0.01) and surgical revascularisation (aHR 0.63, 95% CI: 0.44-0.89; p=0.017), no difference in death rates (p=0.10), but an increased risk of endovascular revascularisation (aHR 1.21, 95% CI: 1.06-1.39; p<0.01) at 1 year. CONCLUSIONS: The use of atherectomy during PVI is common and is not associated with an increase in IH adverse events. Longitudinally, patients treated with atherectomy undergo repeat endovascular reintervention more frequently but experience a reduced risk of amputation and surgical revascularisation.

The association of major adverse limb events and combination stent and atherectomy in patients undergoing revascularization for lower extremity peripheral artery disease.

BACKGROUND: The effectiveness of combined atherectomy and stenting relative to use of each procedure alone for the treatment of lower extremity peripheral artery disease has not been evaluated. AIMS: The objective of this study was to evaluate the short- and long-term major adverse limb event (MALE) following the receipt of stenting, atherectomy, and the combination of stent and atherectomy. METHODS: A retrospective cohort of patients undergoing atherectomy, stent, and combination stent atherectomy for lower extremity peripheral artery disease was derived from the Vascular Quality Initiative (VQI) data set. The primary outcome was MALE and was assessed in the short-term and long-term. Short-term MALE was assessed immediately following the procedure to discharge and estimated using logistic regression. Long-term MALE was assessed after discharge to end of follow-up and estimated using the Fine-Gray subdistribution hazard model. RESULTS: Among the 46,108 included patients, 6896 (14.95%) underwent atherectomy alone, 35,774 (77.59%) received a stent, and 3438 (7.5%) underwent a combination of stenting and atherectomy. The adjusted model indicated a significantly higher odds of short-term MALE in the atherectomy group (OR = 1.35; 95% confidence interval [CI]:1.16-1.57), and not significantly different odds (OR = 0.93; 95% CI:0.77-1.13) in the combination stent and atherectomy group when compared to stenting alone. With regard to long-term MALE, the model indicated that the likelihood of experiencing the outcome was slightly lower (HR = 0.90; 95% CI:0.82-0.98) in the atherectomy group, and not significantly different (HR = 0.92; 95% CI:0.82-1.04) in the combination stent and atherectomy group when compared to the stent group. CONCLUSIONS: Patients in the VQI data set who received combination stenting and atherectomy did not experience significantly different rates of MALE when compared with stenting alone. It is crucial to consider and further evaluate the influence of anatomical characteristics on treatment strategies and potential differential effects of comorbidities and other demographic factors on the short and long-term MALE risks.

Treatment effect of medial arterial calcification in below-knee after Auryon laser atherectomy using micro-CT and histologic evaluation.

PURPOSE: To determine the frequency of medial arterial calcification (MAC) fracture following Auryon laser atherectomy using micro-CT and histologic evaluation in an atherosclerotic human cadaveric limb model. METHODS: Two below-the-knee calcified arterial segments from human cadaver limbs underwent treatment with the Auryon laser system with or without plain old balloon angioplasty (POBA). Micro-CT and angiography were performed before and after treatment followed by histological evaluation of regions showing calcium disruption. RESULTS: All treatment zones were successfully treated with the Auryon laser (n = 9). Six of 9 treatment zones showed calcium fracture on micro-CT. Each treatment zone was further subdivided using micro-CT analysis (36 evaluated sections) of which 18 sections revealed calcium fracture. Sections with calcium fracture had significantly more confluent and uninterrupted circumferential calcification than sections without calcium fracture (arc of calcification 360.0 [323.7-360.0] vs 312.8 [247.4-314.2] degree, p = 0.007), whereas there were no differences in size of calcium burden (3.4 [2.8-3.9] vs 2.8 [1.3-4.6] mm2, p = 0.46). No arterial dissection or rupture was seen. CONCLUSIONS: Auryon laser atherectomy produced fractures of medial arterial calcification in this cadaveric human atherosclerotic peripheral artery model. This effect was observed in arterial segments with a pattern of circumferential uninterrupted calcification (i.e. larger arc of calcification) regardless of calcium burden. Our pilot data suggests Auryon laser may be a promising therapy for calcified lesions.

Market competition influences practice patterns in management of patients with intermittent claudication in the vascular quality initiative.

OBJECTIVE: The Society for Vascular Surgery (SVS) clinical practice guidelines recommend best medical therapy (BMT) as first-line therapy before offering revascularization to patients with intermittent claudication (IC). Notably, atherectomy and tibial-level interventions are generally discouraged for management of IC; however, high regional market competition may incentivize physicians to treat patients outside the scope of guideline-directed therapy. Therefore, we sought to determine the association between regional market competition and endovascular treatment of patients with IC. METHODS: We examined patients with IC undergoing index endovascular peripheral vascular interventions (PVI) in the SVS Vascular Quality Initiative from 2010 to 2022. We assigned the Herfindahl-Hirschman Index as a measure of regional market competition and stratified centers into very high competition (VHC), high competition, moderate competition, and low competition cohorts. We defined BMT as preoperative documentation of being on antiplatelet medication, statin, nonsmoking status, and a recorded ankle-brachial index. We used logistic regression to evaluate the association of market competition with patient and procedural characteristics. A sensitivity analysis was performed in patients with isolated femoropopliteal disease matched by the TransAtlantic InterSociety classification of disease severity. RESULTS: There were 24,669 PVIs that met the inclusion criteria. Patients with IC undergoing PVI were more likely to be on BMT when treated in higher market competition centers (odds ratio [OR], 1.07 per increase in competition quartile; 95% confidence interval [CI], 1.04-1.11; P < .0001). The probability of undergoing aortoiliac interventions decreased with increasing competition (OR, 0.84; 95% CI, 0.81-0.87; P < .0001), but there were higher odds of receiving tibial (OR, 1.40; 95% CI, 1.30-1.50; P < .0001) and multilevel interventions in VHC vs low competition centers (femoral + tibial OR, 1.10; 95% CI, 1.03-1.14; P = .001). Stenting decreased as competition increased (OR, 0.89; 95% CI, 0.87-0.92; P < .0001), whereas exposure to atherectomy increased with higher market competition (OR, 1.15; 95% CI, 1.11-1.19; P < .0001). When assessing patients undergoing single-artery femoropopliteal intervention for TransAtlantic InterSociety A or B lesions to account for disease severity, the odds of undergoing either balloon angioplasty (OR, 0.72; 95% CI, 0.625-0.840; P < .0001) or stenting only (OR, 0.84; 95% CI, 0.727-0.966; P < .0001) were lower in VHC centers. Similarly, the likelihood of receiving atherectomy remained significantly higher in VHC centers (OR, 1.6; 95% CI, 1.36-1.84; P < .0001). CONCLUSIONS: High market competition was associated with more procedures among patients with claudication that are not consistent with guideline-directed therapy per the SVS clinical practice guidelines, including atherectomy and tibial-level interventions. This analysis demonstrates the susceptibility of care delivery to regional market competition and signifies a novel and undefined driver of PVI variation among patients with claudication.

Retrospective Review of Directional Atherectomy and Drug-Coated Balloon Use in a PAD Safety-Net Population.

BACKGROUND: Peripheral artery disease (PAD) is associated with high morbidity and mortality, particularly once patients develop critical limb threatening ischemia (CLTI). Minorities and vulnerable populations often present with CLTI and experience worse outcomes. The use of directional atherectomy (DA) and drug-coated balloon (DCB) during lower-extremity revascularization (LER) has not been previously described in a safety-net population. OBJECTIVE: To review demographic and clinical characteristics, and short- intermediate term outcomes of patients presenting to a safety-net hospital with PAD treated with DA and DCB during LER. METHODS: In this retrospective, observational cohort study, chart review was performed of all patients who underwent DA and DCB during LER for PAD from April 2016 to January 2020 in a safety-net hospital. RESULTS: The analysis included 58 patients, with 41% female, 24% Black/African American, and 31% Hispanic. From this group, 17% spoke a non-English primary language and 10% reported current or previous housing insecurity. Most (65%) presented with CLTI and had undergone a previous index leg LER (58%). The combination of DA and DCB was efficacious, resulting in low rates of bail-out stenting (16%) and target-vessel revascularization (26%) at 2 years. Low complication rates (tibial embolism in 12% and vessel perforation in 2% of cases) were also observed. Most patients (67%) with Rutherford category 5 experienced wound healing by 2 years. CONCLUSION: In this safety-net population, the majority presented with CLTI and a previous LER of the index leg. The combination of DA and DCB resulted in low complication rates, and good short-intermediate outcomes in this frequently undertreated population.

Women are Not at Higher Risk for Reintervention or Major Amputation after Lower Extremity Atherectomy for Peripheral Artery Disease.

BACKGROUND: Our objective was to compare short-term and long-term differences in reintervention-free and major amputation-free survival between female and male patients undergoing lower extremity atherectomy for peripheral artery disease. METHODS: We analyzed lower extremity atherectomy procedures performed on 294 patients between January 2014 and September 2019. Reintervention was defined as either open bypass or endovascular procedure to the same region following the index operation. Kaplan-Meier (KM) survival analysis was performed to compare reintervention-free and major amputation-free survival between sexes. Multivariate logistic regression analyses were performed to determine the adjusted odds of reintervention and major amputation based on sex. We conducted subgroup analyses by anatomic region (femoropopliteal vs. tibial), indication (claudication vs. chronic limb-threatening ischemia (CLTI)), and balloon type (drug-coated balloon (DCB) versus plain balloon angioplasty (POBA)) across sexes. RESULTS: Of the 294 patients, 125 (42.5%) were female. Compared to men, women receiving atherectomy were more likely to be Black (28.0% vs. 16.6%; P = 0.018), a nonsmoker (44.8% vs. 21.3%; P < 0.001), and present with CLTI (55.2% vs. 43.2%; P = 0.042). There were no differences in atherectomy region, lesion type, or balloon type between sexes. KM analysis showed similar 4-year reintervention-free survival (68.8% vs. 75.1%; P = 0.88) and major amputation-free survival (97.6% vs. 97.6%; P = 0.41) between sexes. Women and men had similar reintervention-free survival when grouped by femoropopliteal (67.9% vs. 70.8%; P = 0.69) or tibial (76.2% vs. 83.9%; P = 0.68) atherectomy region. Indication (claudication versus CLTI) did not affect reintervention-free survival in either women (64.5% vs. 69.6%; P = 0.28) or men (68.5% vs. 76.7%; P = 0.84). KM curves for DCB versus POBA were also similar between sexes and showed an early benefit in reintervention rate favoring DCB, which dissipated in both women (65.4% vs. 72.7%; P = 0.61) and men (75.5% vs. 78.4%; P = 0.18) by 3 years. CONCLUSIONS: Compared to men, women demonstrate commensurate benefit from atherectomy for lower extremity revascularization. There were no differences seen in long-term reintervention or major amputation between sexes.

Percutaneous Coronary Intervention and Discretionary Atherectomy in Patients with Aortic Stenosis: 2016-2019 National Inpatient Sample.

BACKGROUND: Patients with aortic stenosis (AS) usually have concomitant calcified coronary artery disease (CAD) requiring atherectomy to improve lesion compliance and odds of successful percutaneous coronary intervention (PCI). However, there is a paucity of data regarding PCI with or without atherectomy in patients with AS. METHODS: The National Inpatient Sample (NIS) database was queried from 2016 through 2019 using ICD-10 codes to identify individuals with AS who underwent PCI with or without atherectomy (Orbital Atherectomy [OA], Rotational or Laser Atherectomy [non-OA]). Temporal trends, safety, outcomes, costs, and correlates of major adverse cardiovascular events (MACE) were assessed using discharge weighted data. RESULTS: Hospitalizations of 45,420 AS patients undergoing PCI with or without atherectomy were identified and of those, 88.6 %, 2.3 %, and 9.1 % were treated with PCI-only, OA, or non-OA, respectively. There was an increase in PCIs (8855 to 10,885), atherectomy [OA (165 to 300) and non-OA (795 to 1255)], and intravascular ultrasound (IVUS) use (625 to 1000). The median cost of admission was higher in the atherectomy cohorts ($34,340.77 in OA, $32,306.2 in non-OA) as compared to the PCI-only cohort ($23,683.98). Patients tend to have decreased odds of MACE with IVUS guided atherectomy and PCI. CONCLUSIONS: This large database revealed a significant increase in PCI with or without atherectomy in AS patients from 2016 to 2019. Considering the complex comorbidities of AS patients, the overall complication rates were well distributed among the different cohorts, suggesting that IVUS guided PCI with or without atherectomy in patients with AS is feasible and safe.

Directional atherectomy combined with drug-coated balloon angioplasty for superficial femoral arteriosclerosis obliterans.

INTRODUCTION: This study is an analysis of the therapeutic effects of directional atherectomy combined with drug-coated balloon angioplasty (DA+DCB) in treating superficial femoral arteriosclerosis obliterans. METHODS: Patients in our hospital with superficial femoral arteriosclerosis obliterans who received DA+DCB during the period June 2016 to February 2019 were identified retrospectively. Preoperative demographics, operative details and postoperative follow-up outcomes were analysed statistically. RESULTS: Between June 2016 and February 2019, 48 patients were enrolled in this retrospective study. The average age of the patients was 66.85 ± 11.28 years; 83.3% of the patients were male. During the procedure, flow-limiting dissection occurred frequently (9/48 patients) and there were six bailout stent implantations owing to flow-limiting dissections. The incidence rate of target artery thrombosis was 4.2% (2/48). There was no vessel perforation, embolism or operation-related death. The technical success rate was estimated at 100%. The mean ankle-brachial index of the patients was 0.54 ± 0.28 before the operation and 0.93 ± 0.13 before discharge (p < 0.0001). The mean follow-up time was 19.6 ± 9.0 months. The primary patency rate was 89.4%, 82.4% and 76.5% at 12, 24 and 36 months. The freedom from target lesion revascularisation (TLR) was 97.9%, 93.8% and 84.4% at 12, 24 and 36 months. CONCLUSION: The use of DA+DCB showed good clinical benefit for superficial femoral arteriosclerosis obliterans, which had good primary patency and freedom from TLR. Multicentre randomised controlled trials with long-term follow-up are needed.

Atherectomy to treat femoropopliteal atherosclerotic disease.

Atherectomy as an endovascular modality to treat peripheral arterial disease has gained traction over the past 10 years. Unlike most other available technologies, atherectomy works by physically debulking atherosclerotic plaque via a variety of mechanisms being the femoropopliteal segment the most targeted one. The aims of this review were to detail the types of atherectomy available, existing evidence available for atherectomy use in the femoropopliteal segment as compared to other interventions, critical appraisal of its current use and the possible influences on its indication. Future steps regarding atherectomy usage and data presentation are also described.

Long-term outcomes of peripheral atherectomy for femoropopliteal endovascular interventions.

BACKGROUND: The use of atherectomy during peripheral endovascular interventions (PVI) has increased dramatically, but data regarding its safety and effectiveness are lacking.  Aims: This study sought to determine the long-term safety of atherectomy in contemporary practice.  Methods: Medicare fee-for-service beneficiaries who underwent femoropopliteal artery PVI from 2015-2018 were identified in a 100% sample of inpatient, outpatient, and carrier file data using procedural claims codes. The primary exposure was the use of atherectomy. Inverse probability of treatment weighting was used to adjust for measured differences in patient populations. Kaplan-Meier methods and multivariable Cox proportional hazards regression were used to compare outcomes.  Results: Among 168,553 patients who underwent PVI, 59,142 (35.1%) underwent atherectomy. The mean patient age was 77.0±7.6 years, 44.9% were female, 81.9% were white, and 46.7% had chronic limb-threatening ischaemia. Over a median follow-up time of 993 days (interquartile range 319-1,377 days), atherectomy use was associated with no difference in the risk of either the composite endpoint of death and amputation (adjusted hazard ratio [aHR] 0.99, 95% confidence interval [CI]: 0.97-1.01; p=0.19) or of major adverse limb events (aHR 1.02, 95% CI: 0.99-1.05; p=0.26). Patients who underwent atherectomy had a modest reduction in the risk of subsequently undergoing amputation or surgical revascularisation (aHR 0.92, 95% CI: 0.90-0.94; p<0.01) but an increase in the risk of undergoing a subsequent PVI (aHR 1.19, 95% CI: 1.16-1.21; p<0.01). CONCLUSIONS: The use of atherectomy during femoropopliteal artery PVI was not associated with an increase in the risk of long-term adverse safety outcomes among patients with peripheral artery disease.