Effects of Peripheral Arterial Disease Interventions on Survival: A Propensity-Score Matched Analysis Using VQI Data.

BACKGROUND: Atherectomy is currently being used extensively for occlusive peripheral artery disease (PAD) interventions without proven benefits. This analysis examines the effects of atherectomy and other endovascular interventions on patient survival. OBJECTIVES: The aim of this study is to compare overall survival for patients undergoing PAD endovascular interventions, such as plain old balloon angioplasty (POBA), stent deployment and atherectomy. METHODS: Propensity score matched cohorts were constructed to conduct pairwise comparisons of overall survival in patients who underwent stenosis and occlusive PAD interventions between May 2011 and February 2020 using Vascular Quality Initiative (VQI) regional registry data. Inverse probability treatment weighting method was used to compare secondary outcomes of in-hospital mortality, length of stay, complications and major amputations. Comparative analysis was performed for POBA vs stenting, POBA vs atherectomy, and stenting vs atherectomy. RESULTS: A total number of 15281 eligible cases were identified. After propensity score matching, 6094, 4032, and 3312 cases were used to compare POBA versus stent deployment, POBA versus atherectomy and stent versus atherectomy, respectively. Stent deployment had significantly better overall survival compared with POBA and atherectomy (P < 0.001). Multivariable Cox proportional hazard models suggested stenting was associated with a reduction in mortality hazard by 30% compared with POBA (HR: 0.7; 95% CI: 0.6-0.82; P < 0.001) and a 40% mortality reduction compared with atherectomy (HR: 0.6; 95% CI: 0.48-0.75; P < 0.001). No significant difference was found between POBA and atherectomy. There was no statistical difference in other secondary outcomes which were comparable among all cohorts. CONCLUSIONS: Stent deployment was significantly superior to POBA and atherectomy in terms of overall survival with comparable complication and amputation rates. The natural history of PAD patients presenting with claudication is associated with an extremely low annual mortality risk. Therefore, further examinations of outcomes, especially in regards to mortality rates, both POBA and atherectomy on the management of PAD patients especially those presenting with claudication is warranted.

Efficacy of Rotational Atherectomy Followed by Drug-coated Balloon Angioplasty for the Treatment of Femoropopliteal Lesions-Comparison with Sole Drug-coated Balloon Revascularization: Two-year Outcomes.

BACKGROUND: We aimed to evaluate the results of the combined use of rotational atherectomy (RA) followed by drug-coated balloon (DCB) treatment against DCB angioplasty alone in patients who had significantly calcified and symptomatic femoropopliteal peripheral arterial disease. METHODS: Patients presented to the clinic with symptoms of chronic limb ischemia of femoropopliteal segment such as moderate or severe claudication and rest pain, who received endovascular therapy between January 2016 and January 2018 in our hospital comprised the study cohort and investigated, retrospectively. Patients with minor or major tissue loss were excluded from the study. We evaluated the effect of RA system followed by DCB with DCB alone in 121 patients and a total of 226 significantly calcified and symptomatic femoropopliteal lesions. Fifty-eight patients and 112 (49.5%) lesions were treated with RA + DCB, whereas 63 patients and 114 (50.5%) lesions were treated with DCB only. The mean age was 61.2 ± 9.7 years. Primary patency is evaluated with duplex ultrasound/angiography at 6, 12, and 24 months and with angiography on 12 and 24 months. Patients were followed up for 24 months to assign clinically driven target lesion revascularization (TLR). Overall survival rates were 96.5% (56/58) in RA + DCB group and 93.6% (59/63) in DCB alone group both at one-year and two-year follow-up. Amputation-free survival rates of RA + DCB and DCB-only groups are 96.5% (56/58) to 87.3% (55/63) at one year, and 94.8% (55/58) to 82.5% (52/63) at two years, respectively. RESULTS: Baseline characteristics of groups were similar. The lesions were longer in the RA + DCB group than the DCB alone group (14.4 ± 5.2 cm vs. 10.2 ± 3.1 cm; P = 0.05). The technical success rate in the RA + DCB group was superior to that of DCB-only group (95.4% vs. 84.8%, P = 0.006). The 12-month and 24-month patency rates with angiography in the RA-DCB group were similar to those in the DCB-only group (85.7% vs. 74.6% and 73.2% vs. 62.7%, respectively). The rates of bailout stenting were significantly lower among patients treated with RA + DCB (n = 3; 5.1% vs. n = 13; 20.6%, P < 0.001). The rates of flow-limiting dissections and vessel recoils after procedures were significantly in RA + DCB group (n = 2; 3.4% vs. n = 8; 12.6%, P < 0.001) than DCB only (n = 1; 1.7% vs. n = 4; 6.3%, P < 0.002). The freedom from TLR rate was significantly increased in the RA + DCB group at 12 months (95.2% vs. 76.3%, P = 0.002) and 24 months (93.4% vs. 63.7%, P = 0.002). The mean ankle brachial index at discharge in the RA-DCB group improved by 0.35 ± 0.24, and in the DCB-only group, it was 0.30 ± 0.23 (P = 0.683). CONCLUSIONS: Combined use of RA and DCB treatment is an effective, safe, and durable method for the treatment of the complex femoropopliteal lesions. Combination of RA and DCB angioplasty reveals increased technical success, fewer flow-limiting dissections, significantly reduced TLR, and bailout stenting rates compared with sole DCB angioplasty.

Atherectomy plus drug-coated balloon versus drug-coated balloon only for treatment of femoropopliteal artery lesions: A systematic review and meta-analysis.

OBJECTIVES: To compare the safety and efficiency of atherectomy plus drug-coated balloon with drug-coated balloon only for the treatment of femoropopliteal artery lesions. METHODS: This systematic review and meta-analysis was performed and reported following the requirement of the PRISMA. EMBASE, MEDLINE, and Cochrane library were queried from January 2000 to June 2020 to identify eligible literature. The modified Downs and Black checklist was used to assess the quality of included studies. Outcome measures included bail-out stenting, distal embolization, perforation, hematoma, primary patency at 12 months, target lesion revascularization at 12 months, leg amputation at 12 months, and mortality at 12 months. We used DerSimonian and Laird random-effects model to pool the dichotomous data on risk ratio (RR) with 95% confidence intervals (CIs) from each study to obtain an overall estimate for major outcomes. Subgroup analysis and sensitivity analyses were conducted. RESULTS: Six studies (two randomized controlled trials and four retrospective cohort studies) with 470 patients were included. Atherectomy plus drug-coated balloon group was associated with lower rates of bail-out stenting (RR: 0.49, 95%CI: 0.34-0.71, P < 0.001). There was no significant difference between two groups in terms of distal embolization (RR: 2.06, 95%CI: 0.51-8.38, P = 0.31), perforation (RR: 2.04, 95%CI: 0.43-9.71, P = 0.37), hematoma (RR: 1.75, 95%CI: 0.43-7.09, P = 0.43), primary patency at 12 months (1.09, 95%CI: 0.98-1.21, P = 0.12), target lesion revascularization at 12 months (RR: 0.68, 95%CI: 0.41-1.14, P = 0.15), leg amputations at 12 months (RR: 0.54, 95%CI: 0.13-2.23, P = 0.39), mortality at 12 months (RR: 2.18, 95%CI: 0.71-6.64, P = 0.17). Sensitivity analysis had no effect on our findings. CONCLUSIONS: The combination of atherectomy and drug-coated balloon was safe and effective in the treatment of femoropopliteal artery lesions, with lower incidence of bail-out stenting compared with drug-coated balloon only.

Rotational atherectomy with adjunctive balloon angioplasty in calcified chronic total occlusions of superficial femoral artery.

OBJECTIVES: The aim was to report the mid-term outcomes of Jetstream™ rotational atherectomy device in complex femoropopliteal lesions. METHODS: Between November 2016 and April 2018, 55 patients who were treated with rotational atherectomy and adjunctive balloon angioplasty due to complex femoropopliteal lesions were retrospectively scanned. RESULTS: Fifty-five patients who underwent endovascular treatment with rotational atherectomy for chronic total occlusive femoropopliteal lesions were included in the study. Technical success rate was 100%. The mean age was 63 (±10.5) years. The cohort included 25 (45.4%) diabetics and 45 (81.8%) current smokers. The mean length of the lesions was 20.8 ± 11.2 cm. Chronic total occlusive lesions were detected in 35 (63.6%) patients, and mixed-type steno-occlusive lesions were detected in 20 patients (36.4%). Thirty-three (60%) lesions were moderate or severely calcified. Adjunctive balloon angioplasty was performed with plain old balloon angioplasty (POBA) on 31 (56.4%) patients and with drug-coated balloon angioplasty on 24 (43.6%) patients. After adjunctive balloon angioplasty, flow limiting dissection was observed in 20 (36.3%) patients, and 17 (30.9%) patients needed stent implantation. The Kaplan-Meier analysis method estimated that the overall primary patency rates at 12 and 24 months were 81.8% and 70.9%, respectively. Overall, secondary patency rates at 12 and 24 months were 94.5% and 80%. No statistically significant differences of 24-month primary patency and secondary patency rates were found between patients treated with drug-coated balloon angioplasty and POBA as an adjunctive therapy, even though primary patency (83.3% vs. 61.3%, p = .06) and secondary patency (91.7% vs. 71%, p = .56) rates of drug-coated balloon angioplasty were slightly higher than POBA. Patients with claudication had better primary patency (90.5% vs. 58.8%, p = .001) and secondary patency (100% vs. 67.6%, p = .004) rates than patients with critical limb ischemia at 24 months. Significant differences between patients who did and did not stop smoking were found in 24-month primary patency (57% vs. 88%, p = .007) and secondary patency (67% vs. 96%, p = .007). Six patients underwent unplanned amputation. There were eight (14.5%) mortalities during follow-up. CONCLUSIONS: Rotational atherectomy with adjunctive balloon angioplasty has satisfactory technical success rates and mid-term outcomes. As an adjunctive method, there was no difference between drug-coated balloon angioplasty s and POBAs. Smoking cessation is always the first-step treatment to improve mid-term patency results. Patients with critical limb ischemia have worse patency results compared to the patients with claudication.

Three-Year Outcomes of Orbital Atherectomy for the Endovascular Treatment of Infrainguinal Claudication or Chronic Limb-Threatening Ischemia.

Purpose: To investigate the outcomes of orbital atherectomy (OA) for the treatment of patients with peripheral artery disease (PAD) manifesting as claudication or chronic limb-threatening ischemia (CLTI). Materials and Methods: The database from the LIBERTY study (ClinicalTrials.gov identifier NCT01855412) was interrogated to identify 503 PAD patients treated with any commercially available endovascular devices and adjunctive OA for 617 femoropopliteal and/or infrapopliteal lesions. Cox regression analyses were employed to examine the association between baseline Rutherford category (RC) stratified as RC 2-3 (n=214), RC 4-5 (n=233), or RC 6 (n=56) and all-cause mortality, target vessel revascularization (TVR), major amputation, major adverse event (MAE), and major amputation/death at up to 3 years of follow-up. The mean lesion lengths were 78.7±73.7, 131.4±119.0, and 95.2±83.9 mm, respectively, for the 3 groups. Results: After OA, balloon angioplasty was used in >98% of cases, with bailout stenting necessary in 2.0%, 2.8%, and 0% of the RC groups, respectively. A small proportion (10.8%) of patients developed angiographic complications, without differences based on presentation. During the 3-year follow-up, claudicants were at lower risk for MAE, death, and major amputation/death than patients with CLTI. The 3-year Kaplan-Meier survival estimates were 84.6% for the RC 2-3 group, 76.2% for the RC 4-5 group, and 63.7% for the RC 6 group. The 3-year freedom from major amputation was estimated as 100%, 95.3%, and 88.6%, respectively. Among CLTI patients only, the RC at baseline was correlated with the combined outcome of major amputation/death, whereas RC classification did not affect TVR, MAE, major amputation, or death rates. Conclusion: Peripheral artery angioplasty with adjunctive OA in patients with CLTI or claudication is safe and associated with low major amputation rates after 3 years of follow-up. These results demonstrate the utility of OA for patients across the spectrum of PAD.

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.

Directional Atherectomy of the Common Femoral Artery: Complications and Outcomes.

BACKGROUND: The use of directional atherectomy (DA) with or without drug-coated balloon (DCB) may be considered for the management of common femoral artery (CFA) occlusive disease because of its minimally invasive nature with early mobilization, reduced incision complications, and infection rates. However, it has recognized complications, which may be related to the learning curve. We present our initial experience using DA and suggest changes that may, based on our practice, improve outcomes. METHODS: Retrospective analysis with a prospective data collection from 2 centers to analyze outcomes in all consecutive patients treated during 1 year (n = 25). Patients who underwent CFA DA with/without DCB for CFA >70% stenosis. Primary end points include technical success, primary patency of the CFA, morbidity, and mortality. Secondary end points include change in Rutherford-Becker class, length of stay, and target lesion revascularization rate. RESULTS: Between July 2017 and December 2018, 25 patients underwent CFA DA. Two had an occluded CFA, and 23 had >70% CFA stenosis as determined by ultrasound scan (USS) and/or computed tomography angiogram (CTA) preoperatively. There were no deaths within 30 days. Procedure-related complications included 2 cases of CFA pseudoaneurysm (one of them repaired by open surgery) and 1 CFA perforation (repaired with covered stent). No distal embolization or limb loss occurred. Mean length of stay was 1.9 days. Primary and secondary patency at 3 and 6 months was 100%. At 12 months, it was 96%. CONCLUSIONS: Early results suggest that CFA DA with/without DCB is safe and effective. Previous CTA, focused USS, and/or intravascular USS may be useful to minimize the risk of pseudoaneurysm or perforation by excessive thinning of the media. Experience is required to prevent localized dilatation over time.

Jetstream Atherectomy System for Treatment of Femoropopliteal Artery Disease: A Single Center Experience and Mid-term Outcomes.

BACKGROUND: The aim of this study is to assess our experience and mid-term outcomes using Jetstream atherectomy system for treatment of femoropopliteal artery disease (FPAD). METHODS: Data of 30 patients with FPAD treated at our center between 2013 and 2016 were analyzed. Two subgroups of patients were identified: Group A included patients (n = 18) with de novo lesions; Group B (n = 12) included those with in-stent restenosis. The primary study end points assessed were technical success, perioperative mortality, and major adverse event (MAE) rate at 30 days (distal embolization, major amputation, and target lesion revascularization). Other outcomes measured were survival, primary, and secondary patency, and freedom from amputation at 1 and 3 years of follow-up, respectively. RESULTS: Technical success was 100% for both groups. The MAE rate was 8.7%. No distal filter was adopted during intervention. Angioplasty was associated with 93.3% of cases (93.3% vs. 100%; P = 0.15), drug-eluting balloon (DEB) in 12 cases (22.2% vs. 66.6%; P = 0.008), drug-eluting stent and bare metal implantation in 1 (5.6% vs. 0%; P = 1) and 4 cases (11.1% vs. 16.7%; P = 1), respectively. The cumulative primary and secondary patency rates were 75.1% and 95.5% at 1 year, and 70.4% and 84.8% at 3 years of follow-up, respectively. The survival and freedom from amputation were 96.4% and 85.8% at 1 and 3 years of follow-up, respectively. The freedom from target lesion revascularization was 91.7% and 83.4% at 1 and 3 years from intervention. CONCLUSIONS: The use of the Jetstream appears to be safe and feasible with no distal embolization and low rate perioperative complications. Moreover, encouraging outcomes were observed when atherectomy was associated to DEB angioplasty.

Midterm Outcome of Directional Atherectomy Combined with Drug-Coated Balloon Angioplasty Versus Drug-Coated Balloon Angioplasty Alone for Femoropopliteal Arteriosclerosis Obliterans.

BACKGROUND: The "leave nothing behind" strategies have been becoming a popular treatment for femoropopliteal arteriosclerosis obliterans. Atherectomy before drug-coated balloon (DCB) angioplasty may have an advantage in improving the efficiency of drug delivery into the blood vessel wall. This study aimed to compare the therapeutic effects of directional atherectomy combined with DCB angioplasty with DCB angioplasty alone in the treatment of femoropopliteal arteriosclerosis obliterans. METHODS: Patients with femoropopliteal arteriosclerosis obliterans who received endovascular therapy from June 2016 to June 2018 in our hospital and presented with life-limiting claudication or severe chronic limb ischemia comprised the study cohort. The patients were randomized to receive directional atherectomy combined with DCB angioplasty (n = 45) or DCB alone (n = 49). Ninety-four patients were enrolled in our study with 72 males, and the mean age was 67 ± 10 years. The mean lesion length was 112 ± 64 mm. RESULTS: There were no significant differences in the baseline characteristics of patients and lesions between the 2 randomized groups (P > 0.05). Flow-limiting dissections occurred more frequently in the DCB group (n = 12; 24.5%) than in the DA-DCB group (n = 2; 4.4%; P = 0.006). The technical success rate in the DA-DCB group was superior to that in the DCB group (95.6% vs. 75.5%, P = 0.006). The mean follow-up duration was 16.7 ± 6.1 months in the DCB group and 15.3 ± 5.8 months in the DA-DCB group. No amputations were performed. The overall mortality in the DCB group was 4.1% (2/49), while all patients survived in the DA-DCB group. The 12-month and 24-month primary patencies in the DA-DCB group were greater than those in the DCB group (80.5% vs. 75.7% and 67.1% vs. 55.1%, respectively); however, using all available patency data, no significant differences over time were observed (P = 0.377). CONCLUSIONS: In this study, directional atherectomy combined with DCB angioplasty can decrease the flow-limiting dissection rate in the treatment of femoropopliteal arteriosclerosis obliterans compared with DCB angioplasty alone. There was no significant difference between the 2 groups in terms of primary patency rate which was needed to be further clarified.

Atherectomy with balloon angioplasty compared to balloon angioplasty alone for the treatment of chronic limb threatening ischemia: A national surgical quality improvement program database analysis.

OBJECTIVES: To compare perioperative outcomes related to atherectomy with percutaneous transluminal angioplasty versus percutaneous transluminal angioplasty alone for the treatment of lower extremity chronic limb threatening ischemia using a national patient database. METHODS: Patients with chronic limb threatening ischemia treated with atherectomy and percutaneous transluminal angioplasty or percutaneous transluminal angioplasty alone from 2011 to 2016 in the National Surgical Quality Improvement Program database were identified. Primary outcomes were major adverse limb events (30-day untreated loss of patency, major reintervention, major amputation) and major adverse cardiac events (cardiac arrest, composite outcome of myocardial infarction or stroke). Secondary outcomes included 30-day mortality, length of stay, and any unplanned readmission within 30 days. Multivariate regression analyses were performed to determine independent predictors of outcome. Propensity score matched cohort analysis was performed. A p-value <0.05 was considered statistically significant. Subgroup analyses of femoropopliteal and infrapopliteal interventions were performed. RESULTS: In total, 2636 (77.2%) patients were treated with percutaneous transluminal angioplasty and 778 (22.8%) were treated with atherectomy and percutaneous transluminal angioplasty. Multivariate analyses of the unadjusted cohort revealed no significant differences in major adverse cardiac events or major adverse limb events between the two groups (p-value >0.05). Subgroup analysis of femoropopliteal interventions demonstrated a significantly decreased likelihood of untreated loss of patency in 30 days in the atherectomy group compared to the percutaneous transluminal angioplasty group (1.1% vs. 2.7%, respectively; p-value = 0.034), which persisted on propensity score matched analysis (1.1% vs. 3.1%, respectively; p-value = 0.026). CONCLUSION: Atherectomy with balloon angioplasty of femoropopliteal disease provides a significant decrease in untreated loss of patency compared to balloon angioplasty alone.

Atherectomy in below-the-knee endovascular interventions: One-year outcomes from the XLPAD registry.

BACKGROUND: Use of atherectomy for the treatment of peripheral arterial disease (PAD) is increasing as an adjunctive treatment to either conventional or drug-coated balloon angioplasty. There is limited data on atherectomy outcomes in below-the-knee (BTK) endovascular interventions. METHODS: Data from the multicenter Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851) were analyzed to examine predictors of atherectomy use and its associated 1-year patency rate. We analyzed 518 BTK procedures performed between January 2005 and December 2016. RESULTS: Overall a total of 518 BTK procedures were treated in 430 patients, and 43% of interventions used atherectomy. African American patients were less likely (13% vs 25%; |standard residual| = 3.41) to be treated with atherectomy. Use of atherectomy was lower in chronic total occlusive (CTO) lesions (48% vs 58%; P = 0.02). There were no significant associations of baseline comorbidities, critical limb ischemia (CLI), ankle-brachial index, number of BTK vessel run-off, or vessel location with atherectomy use. Compared with patients without atherectomy, use of atherectomy was associated with lower incidence of repeat target limb intervention at 1 year after adjusting for age, CLI, in-stent restenosis, heavy calcification, presence of diffuse disease, and CTO lesion traits (Hazard Ratio 0.41, 95% confidence interval 0.23-0.72; P < 0.01). CONCLUSIONS: Compared with no atherectomy, use of atherectomy in BTK interventions is associated with lower rates of 1-year repeat target limb revascularization. These findings require confirmation in prospective, randomized clinical studies.

Effect of hospital volume on outcomes of percutaneous peripheral atherectomy - An observational analysis from National Inpatient Sample.

BACKGROUND: Although the published literature has reported an inverse association between hospital volume and outcomes of coronary interventions, sparse data are available for percutaneous peripheral atherectomy (PPA). The aim of our study was to examine the effect of hospital volume on outcomes of PPA. METHODS: Using the Nationwide Inpatient Sample (NIS) database of the year 2012, PPA with ICD-9 code of 17.56 was identified. The primary outcomes were mortality and amputation rates; secondary outcomes were peri-procedural complications, cost, and length of hospitalization and discharge disposition of the patient. Multivariate models were generated for predictors of the outcomes. RESULTS: We identified a total of 21,015 patients with mean age of 69.53 years, with 56% males. Higher hospital volume centers were associated with a significantly lower mortality (OR 0.42, 95% CI 0.30-0.57, p < 0.0001), amputation rates (5.34% vs. 9.32%, p < 0.0001), combined endpoint of mortality and complications (OR 0.53, 95% CI 0.49-0.58, p < 0.0001), shorter length of hospital stay (LOS) (4.86 vs. 6.79 days, p < 0.0001) and lower hospitalization cost ($23,062 vs. $30,794, p < 0.0001). Subgroup analysis for acute and chronic limb ischemia showed similar results. CONCLUSION: Hospital procedure volume is an independent predictor of mortality, amputation rates, complications, LOS, and costs in patients undergoing PPA with an inverse relationship.

Utilization and in-hospital outcomes associated with atherectomy in the treatment of peripheral vascular disease: An observational analysis from the National Inpatient Sample.

Objective Percutaneous revascularization for patients with peripheral arterial disease has become a treatment of choice for many symptomatic patients. The presence of severe arterial calcification presents many challenges for successful revascularization. Atherectomy is an adjunctive treatment option for patients with severe calcification undergoing percutaneous intervention. We sought to analyze the impact of atherectomy on in-hospital outcomes, length of stay, and cost in the percutaneous treatment of peripheral arterial disease. Methods Patients with lower extremity peripheral arterial disease undergoing percutaneous revascularization were assessed, utilizing the National Inpatient Sample (2012-2014) and appropriate International Classification of Diseases, 9th Revision, Clinical Modification diagnostic and procedural codes. Patients who were not treated with atherectomy ( n = 51,037) were compared to those treated with atherectomy ( n = 11,408). Propensity score-matched analysis was performed to address baseline differences. Results After performing propensity score-matched analysis, 11,037 patients were included in each group. Utilization of atherectomy was associated with lower in-hospital mortality (2% vs. 1.4% p = 0.0006). All secondary outcomes were lower when using atherectomy except acute renal failure. Length of stay was slightly lower when using atherectomy (7.2 vs. 7.0 days, p = 0.0494). However, median cost was higher in patients treated with atherectomy ($21,589 vs. $24,060, p = <0.0001). Conclusion The use of atherectomy was associated with significantly decreased in-hospital mortality, adverse events, and length of stay. Though, cost associated with atherectomy use is increased, this is offset by decreased in-hospital adverse outcomes. Appropriate use of atherectomy devices is an important tool in revascularization of peripheral arterial disease in select patients.

Distal embolization during lower extremity endovascular interventions.

OBJECTIVE: Distal embolization (DE) during peripheral arterial endovascular interventions is a well-known complication that is poorly studied. The goal of this study was to determine the incidence, risk factors, and effect of DE on the outcomes of lower extremity endovascular interventions (LEIs). METHODS: All LEIs between 2010 and 2014 in the Vascular Study Group of New England (VSGNE) database were reviewed. Patient characteristics were analyzed to determine predictors of DE. LEIs involving the superficial femoral artery (SFA) were reviewed to assess the effect of type of treatment on DE. The outcomes examined were loss of patency, limb loss, and mortality after LEI involving the SFA. A multivariable regression was used to determine predictors of DE. RESULTS: There were 10,875 procedures. The incidence of DE was 17.3 per 1000 procedures, and 68% required treatment (57% endovascular, 11% open surgery). DE was more common in patients treated for critical limb ischemia compared with claudication (relative risk [RR], 2.06; 95% confidence interval [CI], 1.24-3.45; P = .006) and for emergency interventions compared with elective (RR, 2.98; 95% CI, 1.22-7.30; P = .017). DE increased with the number of arteries treated (P < .0001) and with the length of occlusion (P < .0001). The SFA was the most commonly treated artery (4751 [43.7%]). In comparison with atherectomy and balloon angioplasty, stenting alone (RR, 0.36; 95% CI, 0.17-0.73; P = .005), balloon angioplasty alone (RR, 0.23; 95% CI, 0.13-0.41; P < .0001), and combined stenting and balloon angioplasty (RR, 0.29; 95% CI, 0.17-0.49; P < .0001) were associated with a significantly lower risk of DE. DE was not significantly associated with loss of patency, major amputation, or mortality. CONCLUSIONS: The incidence of DE during LEIs is 1% to 2% in the VSGNE database, and most patients are treated with additional endovascular interventions. The incidence increases in patients with critical limb ischemia and with the use of atherectomy.

Percutaneous common femoral artery interventions using angioplasty, atherectomy, and stenting.

BACKGROUND: This study evaluated the feasibility, safety, and effectiveness of endovascular interventions for common femoral artery (CFA) occlusive disease. METHODS: Using a prospectively maintained multicenter database, we analyzed outcomes in 167 consecutive patients who underwent percutaneous CFA interventions for Rutherford class 3 to class 6 (R3-R6) disease. The standardized treatment approach included primary percutaneous transluminal angioplasty (PTA) only, atherectomy + PTA, and provisional stenting. Outcomes included technical failure rate, recurrence, complications, and major or minor amputation rate. Data were analyzed using multivariate regression analysis. RESULTS: During a 7-year period, 167 patients with R3 (n = 91 [54.5%]) and R4 to R6 (n = 76 [45.5%]) disease underwent CFA interventions that included PTA only (n = 114 [68.2%]), atherectomy ± PTA (n = 38 [22.8%]), and provisional stenting (n = 15 [9.0%]) for failed atherectomy ± PTA. Procedure-related complications included pseudoaneurysm (n = 1 [0.6%]), thrombosis (n = 1 [0.6%]), distal embolization (n = 1 [0.6%]), and death (R6, n = 1 [0.06%]). CFA restenosis was observed in 34 (20.4%) patents; these underwent further percutaneous (n = 18 [10.8%]) or surgical (n = 17 [10.2%]) revascularization that included CFA endarterectomy ± femoral distal bypass. Major or minor amputations were observed in none of the R3 patients and in only three (3.9%) and five (6.5%) of the R4 to R6 patients, respectively. Compared with the atherectomy + PTA group, patients in the PTA-only group had a significantly lower patency. Furthermore, during long-term mean follow-up of 42.5 months, the CFA provisional stent group had a 100% primary patency, which was significantly better than the primary patency in the CFA nonstent groups combined (77.0%; P = .0424). CONCLUSIONS: Data from this study to date would suggest that percutaneous CFA interventions in select patients are relatively safe and effective. In the long term, CFA stenting has significantly better primary patency than CFA atherectomy and PTA combined. CFA atherectomy + PTA has significantly better primary patency than CFA PTA-only at midterm, especially in patients with claudication. Future randomized controlled trials are warranted.

Endovascular treatment of lesions in the below-knee popliteal artery.

BACKGROUND: Endovascular interventions are increasing; however, there are little data regarding outcomes of complex interventions involving the below-knee popliteal/P3 artery. This study evaluated the short-term and long-term results and predictors of success of below-knee popliteal artery endovascular interventions. METHODS: This was a retrospective review of a prospectively maintained endovascular lower extremity database of all patients with below-knee popliteal interventions from 2004 to 2012. Patient demographics, angiographic findings, interventions, primary and secondary patency, limb loss, and mortality were recorded. Analysis was performed using Kaplan-Meier life-table and multivariate analysis, with P < .05 indicating significance. RESULTS: There were 221 patients (56% male) with below-knee popliteal/P3 artery lesions. Mean age was 73 ± 11.2 years. Claudication was present in 22% and critical limb ischemia (CLI) in 78%. Mean lesion length was 10 ± 8.5 cm, with 45% having total occlusions. Treatment included percutaneous transluminal angioplasty (PTA) with or without a stent (47%), atherectomy (ATH) with or without PTA/stent (52%), and stenting with PTA and ATH (3%). Complications included embolization (0.4%), hematoma (2.7%), pseudoaneurysm (1.3%), and dissection (7%). Freedom from restenosis (peak systolic velocity ratio >2.4) was 65% at 1 year. Independent predictors of restenosis were CLI (hazard risk [HR], 4.4; 95% confidence interval [CI], 1.9-9.9) and stenting combined with PTA and ATH (HR, 2.7; 95% CI, 1.01-7.4). Primary assisted and secondary patencies were 95% and 85% at 1 year. ATH with PTA had lower short-term restenosis in diabetic patients compared with nondiabetic patients (95% vs 78% at 4 months). Limb loss was 18% at 4 years. Mortality was 24% at 4 years. Statin use was protective against primary restenosis (HR, 0.39; 95% CI, 0.23-0.67) and death (HR, 0.5; 95% CI, 0.28-1.0). CONCLUSIONS: Endovascular intervention for lesions involving the below-knee popliteal artery is a safe and effective therapy for claudication and CLI. Diabetic patients benefit most from ATH with PTA. Statin use is protective against restenosis and mortality and should be the standard of care in patients undergoing peripheral endovascular interventions.

Atherectomy for peripheral arterial disease.

BACKGROUND: Symptomatic peripheral arterial disease may be treated by a number of options including exercise therapy, angioplasty, stenting and bypass surgery. Atherectomy is an alternative technique where atheroma is excised by a rotating cutting blade. OBJECTIVES: The objective of this review was to analyse randomised controlled trials comparing atherectomy against any established treatment for peripheral arterial disease in order to evaluate the effectiveness of atherectomy. SEARCH METHODS: The Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched November 2013) and CENTRAL (2013, Issue 10). Trials databases were searched for details of ongoing or unpublished studies. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing atherectomy and other established treatments were selected for inclusion. All participants had symptomatic peripheral arterial disease with either claudication or critical limb ischaemia and evidence of lower limb arterial disease. DATA COLLECTION AND ANALYSIS: Two review authors (GA and CT) screened studies for inclusion, extracted data and assessed the quality of the trials. Any disagreements were resolved through discussion. MAIN RESULTS: Four trials were included with a total of 220 participants (118 treated with atherectomy, 102 treated with balloon angioplasty) and 259 treated vessels (129 treated with atherectomy, 130 treated with balloon angioplasty). All studies compared atherectomy with angioplasty. No study was properly powered or assessors blinded to the procedures and there was a high risk of selection, attrition, detection and reporting biases.The estimated risk of success was similar between the treatment modalities although the confidence interval (CI) was compatible with small benefits of either treatment for the initial procedural success rate (Mantel-Haenszel risk ratio (RR) 0.92, 95% CI 0.44 to 1.91, P = 0.82), patency at six months (Mantel-Haenszel RR 0.92, 95% CI 0.51 to 1.66, P = 0.79) and patency at 12 months (Mantel-Haenszel RR 1.17, 95% CI 0.72 to 1.90, P = 0.53) following the procedure. The reduction in all-cause mortality with atherectomy was most likely due to an unexpectedly high mortality in the balloon angioplasty group in one of the two trials that reported mortality (Mantel-Haenszel RR 0.24, 95% CI 0.06 to 0.91, P = 0.04). Cardiovascular events were not reported in any study. There was a reduction in the rate of bailout stenting following atherectomy (Mantel-Haenszel RR 0.45, 95% CI 0.24 to 0.84, P = 0.01), and balloon inflation pressures were lower following atherectomy (mean difference -2.73 mmHg, 95% CI -3.48 to -1.98, P < 0.00001). Complications such as embolisation and vessel dissection were reported in two trials indicating more embolisations in the atherectomy group and more vessel dissections in the angioplasty group, but the data could not be pooled. From the limited data available, there was no clear evidence of different rates of adverse events between the atherectomy and balloon angioplasty groups for target vessel revascularisation and above-knee amputation. Quality of life and clinical and symptomatic outcomes such as walking distance or symptom relief were not reported in the studies. AUTHORS' CONCLUSIONS: This review has identified poor quality evidence to support atherectomy as an alternative to balloon angioplasty in maintaining primary patency at any time interval. There was no evidence for superiority of atherectomy over angioplasty on any outcome, and distal embolisation was not reported in all trials of atherectomy. Properly powered trials are recommended.

Drug-coated balloon angioplasty after directional atherectomy improves outcome in restenotic femoropopliteal arteries.

BACKGROUND: Restenosis remains an unresolved problem despite different treatment modalities and new stent technology in femoropopliteal arteries. No standard therapy has proven to provide acceptable outcome data for this entity. Directional atherectomy alone did not result in satisfactory long-term patency rates. The outcome might be improved in conjunction with drug-coated balloon angioplasty. METHODS: In this retrospective study, restenotic lesions of the femoropopliteal arteries were treated with directed atherectomy in 89 lesions of consecutive patients (58% male; mean age, 69 ± 11 years). All patients received adjunctive treatment with conventional balloon percutaneous angioplasty (PTA; n = 60) or drug-coated balloon angioplasty (DCB; n = 29). RESULTS: Lesion location was in the stent (DCB [n = 27] vs PTA [n = 36]) and in native restenotic vessels (DCB [n = 2] vs PTA [n = 25]). The 1-year Kaplan-Meier freedom from restenosis estimates (95% confidence intervals) in the DCB and PTA groups were 84.7% (70.9%-98.5%) and 43.8% (30.5%-57.1%), respectively. In a multivariable Cox model for restenosis, DCB treatment had a hazard ratio (95% confidence interval) of 0.28 (0.12-0.66; P = .0036) compared with the PTA group. In the multivariable model for procedural success, the effect of treatment did not differ between PTA and DCB (P = .134). CONCLUSIONS: The combination of directed atherectomy with adjunctive DCB is associated with a better event-free survival at 12 months of follow-up compared with PTA after directed atherectomy.

Atherectomy offers no benefits over balloon angioplasty in tibial interventions for critical limb ischemia.

BACKGROUND: Endovascular adjuncts, like atherectomy, were developed to improve outcomes of endovascular arterial interventions. The true impact of atherectomy on endovascular outcomes remains to be determined, and little data exist on the influence of atherectomy on tibial interventions. Our study compares early and late outcomes of tibial intervention with angioplasty vs atherectomy-assisted interventions. METHODS: We completed a retrospective review of all tibial interventions between 2008 and 2010. Outcomes were analyzed using single and multivariate analysis, Cox regression, and Kaplan-Meier curves. Primary outcomes were primary, primary assisted, and secondary patency rates, as well as limb salvage and survival rates. RESULTS: Over a 2-year period, 480 tibial interventions were completed for 421 patients. Eighty-seven percent (n = 418) of interventions were performed for critical limb ischemia (CLI) and 13% (n = 62) for claudication. The CLI cohort of 418 interventions was analyzed. These patients had a mean age of 71 years with a mean follow-up time of 16 ± 15 months (range, 0-59 months). Of the 418 interventions, 339 underwent percutaneous transluminal angioplasty (PTA): 333 PTA alone, six PTA + stent. The remaining 79 interventions received atherectomy: 33 laser, 13 directional, and 33 orbital either alone or in conjunction with PTA (11 atherectomy only, 68 atherectomy + PTA). The groups did not differ significantly in terms of demographics, risk factors, or technical success. The atherectomy group had more TASC B lesions (54% vs 38%; P = .013), while the PTA-alone group had more TASC D lesions (25% vs 13%; P = .004). TASC A and C lesions did not differ significantly between the groups. No significant differences existed with respect to the early (30-day) outcomes of loss of patency (11% vs 13%; P = .699), complications (8% vs 13%; P = .292), or major amputation (17% vs 13%; P = .344) in the PTA-alone group vs the atherectomy-assisted group. Kaplan-Meier analysis revealed no difference for all primary outcomes of PTA alone vs the atherectomy-assisted group at 12 and 36 months: primary patency (69%, 55% vs 61%, 46%; P = .158), primary assisted patency (83%, 71% vs 85%, 67%; P = .801), secondary patency (94%, 89% vs 95%, 89%; P = .892), limb salvage (79%, 70% vs 81%, 77%; P = .485), or survival (77%, 56% vs 80%, 50%; P = .944). CONCLUSIONS: The adjunctive use of atherectomy offered no improvement in primary outcomes over PTA alone in either early or late outcomes in CLI patients who underwent endovascular tibial interventions. Considering the additional cost and increased procedural time, these findings put into question the routine use of adjunctive atherectomy.

Long-term results of plaque excision combined with aggressive pharmacotherapy in high-risk patients with advanced peripheral artery disease (SAVE a LEG registry).

BACKGROUND: In United States alone there are more than 12 million people with peripheral artery disease (PAD). Long-term outcomes of plaque excision in high-risk population (patients with diabetes and patients with end stage renal disease on dialysis) are scarce. METHODS: Since November 2003, we treated 225 consecutive patients (138 male, mean age: 66.3 ± 12.4, range: 29-93) with SilverHawk(TM) plaque excision for critical limb ischemia or disabling claudication. A total of 367 procedures were performed treating 832 lesions (157 restenotic, 675 de novo). One hundred fifty-five patients (68.9%) were diabetics, 74 (32.9%) were on dialysis. All patients were treated with statins, clopidogrel, aspirin, and aggressive glycemic control. The primary endpoint for our study was target lesion revascularization (TLR), and the secondary endpoint was an assessment of major adverse events (all cause death, amputation, TLR). RESULTS: The average time of observation was 2.2 ± 1.2 years. Procedural success rate was 99.4% with <30% residual stenosis achieved in 818 (98.9%) lesions. SilverHawk was used alone in 86.7%. No acute limb loss or major perforation occurred. Sixty (26.6%) patients had TLR. Long-term mortality was 16.4%. Seven (3.1%) patients had to undergo major amputations and 7 (3.1%) minor amputations. Seventy (31.1%) patients had a major adverse event. Atorvastatin 80 mg was found to be independent predictor of survival, and major amputation was found to be independent predictor of mortality. CONCLUSIONS: SilverHawk Plaque Excision combined with aggressive pharmacotherapy in this presented high-risk population is associated with promising long-term outcomes that compare favorably with accepted standards of care.