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.

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.

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.

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.

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 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.

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.

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.

Acute and 30-Day Safety and Effectiveness Evaluation of Eximo Medical's B-Laser™, a Novel Atherectomy Device, in Subjects Affected With Infrainguinal Peripheral Arterial Disease: Results of the EX-PAD-03 Trial.

BACKGROUND: B-Laser™ is a novel atherectomy device that uses a solid-state third harmonic pulsed Nd:YAG laser with an output of 355 nm. Early data showed that the B-Laser™ is safe in treating a broad range of infrainguinal arterial lesions. We present the results of the EX-PAD-03 U.S. pivotal trial of the EXIMO B-Laser™. METHODS: EX-PAD-03 is a prospective, single-arm, multi-center, international, open-label, clinical study. The study enrolled patients in the United States and Europe. The primary efficacy endpoint was the average reduction in residual diameter stenosis of >20% from baseline prior to any adjunctive therapy achieved by the B-Laser™ catheter alone. The primary safety endpoint was freedom from major adverse events (MAEs) defined as: unplanned target limb amputation above the ankle, clinically driven target lesion revascularization (CD-TLR) and cardiovascular related death. RESULTS: A total of 97 subjects (107 lesions) were enrolled. Mean age was 70.5 years and 51% were males. Diabetes mellitus was present in 42.3%. Mean lesion length was 53.96 ±â€¯43.18 mm and 26.2% had severe calcification. Lesions were de novo (79.4%), followed by in-stent restenosis (ISR) (15.9%) and non in-stent restenosis (4.7%). The mean percent stenosis at the target lesion as assessed by the Core lab was 85.7% ±â€¯12.2 (femoro-popliteal 85.6 ±â€¯12.8%; tibials 86.0 ±â€¯9.6%). Post B-Laser™ and prior to adjunctive therapy, the mean percent stenosis at the target lesion was 52.1%. This resulted in a mean reduction from baseline to post B-Laser™ of 33.6% ±â€¯14.2% meeting the primary efficacy endpoint goal. The freedom from MAE through the 30-day follow-up period after intervention was 98.9%. Per Core lab, there was no device-related distal embolization, dissections that required additional therapy, perforation, or pseudoaneurysm. Bailout stenting was 0.9%. A significant improvement from baseline in ABI (0.24 ±â€¯0.18), Rutherford category (-1.79 ±â€¯1.22) and WIQ (0.26 ±â€¯0.28) were noted at 1 month. There was no target lesion revascularization and the patency was 96.8% by duplex ultrasound criteria at 30-day follow up. CONCLUSION: The Eximo B-Laser™ is effective and safe in ablating atherosclerotic and restenotic tissue for both above and below the knee obstructive arterial disease. The device has a high safety profile including a low risk of distal embolization.

Role of Sex in Determining Treatment Type for Patients Undergoing Endovascular Lower Extremity Revascularization.

Background Limited data exist to describe factors that influence the use of different endovascular treatments for peripheral arterial disease. Therefore, we studied sex differences in the utilization of endovascular treatment modalities and their impact on arterial patency. Methods and Results We analyzed procedures from 2010 to 2016 in the Vascular Quality Initiative for arteries treated with percutaneous transluminal angioplasty (PTA) alone, stenting (with/without PTA), and atherectomy (with/without PTA). We explored sex differences in treatment modality by arterial segment (iliac, femoropopliteal, and tibial) with multivariable logistic regression. We used Kaplan-Meier survival analysis and multivariable Cox regression to study sex differences in arterial reintervention and occlusion. In this cohort, patients (n=58 247, mean age 68 years, 41% women,) had 106 073 arteries treated (median=2 arteries, interquartile range=1-3). Half (50%) of these arteries were treated with stents, 39% with PTA alone, and 11% with atherectomy. After risk adjustment, women were less likely to undergo stenting or atherectomy (versus PTA alone) in the femoropopliteal (stent risk ratio=0.78 [0.74-0.82]; atherectomy risk ratio=0.69 [0.58-0.82]) and tibial arteries (stent risk ratio=0.70 [0.55-0.89]; atherectomy risk ratio=0.87 [0.70-1.07]). In the iliac arteries there was no sex difference in stenting, and atherectomy was rarely used (0.2%). Women underwent reintervention in the femoropopliteal arteries (hazard ratio=1.28 [1.17-1.40]) or developed an occlusion in the iliac (hazard ratio=1.42 [1.12-1.81]) and femoropopliteal arteries (hazard ratio=1.19 [1.06-1.34]) more frequently than men. Conclusions Women were less likely to undergo stenting or atherectomy and had higher rates of occlusion and reintervention, especially in the femoropopliteal arteries. Evidence-based guidelines are needed to guide optimal use of endovascular treatments for men and women.

Propensity Score-Adjusted Comparison of Long-Term Outcomes Among Revascularization Strategies for Critical Limb Ischemia.

BACKGROUND: Few studies have compared long-term outcomes among specific treatment modalities for critical limb ischemia. The aim of this study was to compare long-term outcomes with percutaneous transluminal angioplasty (PTA), stent placement, atherectomy, or surgical bypass in patients diagnosed with critical limb ischemia. METHODS: In this observational study using Medicare claims data, we identified incident cases with a primary critical limb ischemia diagnosis who received PTA, stent placement, atherectomy, or surgical bypass. We used propensity score weighting to determine the association of treatment type with all-cause mortality and major (above ankle) amputation over 4 years follow-up. RESULTS: Among 36 860 patients (10 904 PTA; 11 295 stent placement; 4422 atherectomy; 10 239 surgical bypass), all-cause mortality over 4 years was 49.3% with atherectomy, 51.4% with surgical bypass, 53.7% with stent placement, and 54.7% with PTA (P<0.05 for all pairwise comparisons). Major amputation rates over 4 years were 6.8% with atherectomy, 7.8% with stent placement, 8.1% with PTA, and 10.8% with surgical bypass (P<0.05 for all pairwise comparison except PTA versus stent). CONCLUSIONS: Among Medicare beneficiaries who received PTA, stent placement, atherectomy, or surgical bypass for critical limb ischemia, high mortality and major amputation rates were observed with minor differences among treatment groups. Statistically significant group differences of uncertain clinical importance were observed for several comparisons. Results from observational research may be susceptible to bias because of unmeasured confounders and, therefore, these comparative results should be interpreted with caution.

In­hospital outcomes of rotational versus orbital atherectomy during percutaneous coronary intervention: a meta­analysis.

BACKGROUND: Data comparing rotational atherectomy (RA) with orbital atherectomy (OA) for calcified lesions is inconclusive and based on single observational studies in populations with limited numbers of patients. AIMS: The aim of the study was to perform a meta­analysis of observational studies comparing RA with OA for calcified lesions prior to percutaneous coronary intervention. METHODS: Electronic databases were searched for studies comparing short­term outcomes of RA with OA prior to percutaneous coronary intervention. Risk ratios (RRs) or mean differences (MD) and 95% confidence intervals (CIs) were calculated using a random­effects model. RESULTS: Meta­analysis included 6 retrospective studies with 1590 patients treated with RA and 721 with OA. The latter was associated with shorter fluoroscopy time (MD, -3.40 min; 95% CI, -4.76 to -2.04; P <0.001, I2 = 0%), but contrast use was similar (MD, -2.78 ml; 95% CI, -16.04 to 10.47; P = 0.68; I2 = 67%). Although coronary dissection occurred 4­fold more frequently with OA (RR, 3.87; 95% CI, 1.37-10.93; P = 0.01; I2 = 0%), perforations (RR, 2.73; 95% CI, 0.46-16.30, P = 0.27; I2 = 41), tamponade (RR, 1.78; 95% CI, 0.37-8.58; P = 0.47; I2 = 0%), and slow or no­reflow phenomenon (RR, 0.81; 95% CI, 0.35-1.84; P = 0.61; I2 = 0%) occurred with similar frequency. The risk of 30­day or in­hospital myocardial infarction was lower in OA as compared with RA (RR, 0.67; 95% CI, 0.47-0.94; P = 0.02; I2 = 0%), yet the risk of in­hospital mortality (RR, 0.73; 95% CI, 0.11-4.64; P = 0.74; I2 = 43%) and length of stay (MD, -0.27 days; 95% CI, -0.76 to -0.23; P = 0.29; I2 = 0%) did not differ. CONCLUSIONS: Orbital atherectomy was associated with a lower risk of early myocardial infarction. However, a higher rate of coronary dissections produced by OA did not translate into increased risk of perforations, slow or no­reflow phenomenon, or in­hospital mortality.

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.

Directional Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency: Twelve-Month Results of the DEFINITIVE AR Study.

BACKGROUND: Studies assessing drug-coated balloons (DCB) for the treatment of femoropopliteal artery disease are encouraging. However, challenging lesions, such as severely calcified, remain difficult to treat with DCB alone. Vessel preparation with directional atherectomy (DA) potentially improves outcomes of DCB. METHODS AND RESULTS: DEFINITIVE AR study (Directional Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency-A Pilot Study of Anti-Restenosis Treatment) was a multicenter randomized trial designed to estimate the effect of DA before DCB to facilitate the development of future end point-driven randomized studies. One hundred two patients with claudication or rest pain were randomly assigned 1:1 to DA+DCB (n=48) or DCB alone (n=54), and 19 additional patients with severely calcified lesions were treated with DA+DCB. Mean lesion length was 11.2±4.0 cm for DA+DCB and 9.7±4.1 cm for DCB (P=0.05). Predilation rate was 16.7% for DA+DCB versus 74.1% for DCB; postdilation rate was 6.3% for DA+DCB versus 33.3% for DCB. Technical success was superior for DA+DCB (89.6% versus 64.2%; P=0.004). Overall bail-out stenting rate was 3.7%, and rate of flow-limiting dissections was 19% for DCB and 2% for DA+DCB (P=0.01). One-year primary outcome of angiographic percent diameter stenosis was 33.6±17.7% for DA+DCB versus 36.4±17.6% for DCB (P=0.48), and clinically driven target lesion revascularization was 7.3% for DA+DCB and 8.0% for DCB (P=0.90). Duplex ultrasound patency was 84.6% for DA+DCB, 81.3% for DCB (P=0.78), and 68.8% for calcified lesions. Freedom from major adverse events at 1 year was 89.3% for DA+DCB and 90.0% for DCB (P=0.86). CONCLUSIONS: DA+DCB treatment was effective and safe, but the study was not powered to show significant differences between the 2 methods of revascularization in 1-year follow-up. An adequately powered randomized trial is warranted. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov. Unique Identifier: NCT01366482.

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.