One-Year Clinical Outcome and Risk Factor Analysis of Directional Atherectomy Followed With Drug-Coated Balloon for Femoropopliteal Artery Disease

Purpose: This study investigated the 1-year clinical outcomes of directional atherectomy combined with drug-coated balloon (DA + DCB) in femoropopliteal artery disease (FPAD) from real-world experience. Materials and Methods: A retrospective study was conducted of patients treated between July 2016 and June 2019 using DA + DCB for FPAD. Patients’ demographics, comorbidities, clinical characteristics and outcomes, and angiography and duplex ultrasound findings were analyzed. The 6-month and 1-year primary patency, primary assisted patency, secondary patency, and freedom from clinically-driven target lesion revascularization (CD-TLR) were evaluated. Univariate and multivariate analyses were performed to identify risk factors of primary patency loss or CD-TLR. Results: Seventy-nine consecutive patients (83 lesions, mean age 70.9 years, 52 men) were included. Twenty-seven limbs had lifestyle-limiting claudication and 56 limbs had critical limb ischemia. There were 73 and 10 limbs with de novo lesion and in-stent restenosis, respectively. The mean lesion length of all the patients was 22.1 cm. The mean length of chronic total occlusions (CTOs) was 8.3 cm. Severe calcification was found in 32.5% cases. The 1-year primary patency rate was 80.8% and freedom from CD-TLR was 92.2%. The bailout stenting rate was 2.4%. Patients with CTO >10 cm had significantly lower 1-year primary patency rate and freedom from CD-TLR than did patients with CTO ≤10 cm. Total length of CTO (stratified as ≤5 cm, 5–10 cm, >10 cm) was identified as an independent risk factor of 1-year primary patency loss and CD-TLR. Conclusion: DA + DCB appears to be a safe and effective endovascular therapy to treat FPAD in real-world clinical practice, with a promising 1-year patency rate with a low rate of bailout stenting.

Atherectomy and Drug-Coated Balloon Angioplasty for the Treatment of Long Infrapopliteal Lesions: A Randomized Controlled Trial

Background: Prospective, randomized, multicenter trials show no beneficial impact of drug-coated balloon (DCB) therapy alone on the technical and clinical outcomes of infrapopliteal artery lesions in comparison to plain old balloon angioplasty. The aim of this study was to evaluate the performance of directional atherectomy (DA) plus DCB angioplasty versus DCB alone in treatment of long infrapopliteal artery lesions. Methods: We conducted a prospective, randomized, 2-center trial comparing the performance of DA+DCB and DCB alone in treatment of 80 patients with de novo infrapopliteal artery lesions. The primary study end point was the 6-month primary patency of the target lesion detected by angiography and duplex ultrasound. Secondary end points included clinically driven target vessel revascularization, amputation rates, and changes in Rutherford-Becker class at 1 year. A core laboratory provides independent analyses for all scheduled and unscheduled duplex ultrasound examinations and angiographies, and a research institute ensured independent data collection. Results: The mean target lesion length was 179.7±98.2 mm. Nine patients (11.3%) died during the follow-up period. At 6 months, primary patency was 49% (n=18) with DA+DCB versus 34% (n=12) with DCB alone ( P =0.241), and clinically driven target vessel revascularization was 8% (n=3) versus 14% (n=5; P =0.475), respectively. At 1 year, the TLR rates were 30% (n=10) versus 43% (n=12; P =0.308), the median in Rutherford-Becker class was 2 (0.25–5) versus 5 (0.25–5; P =0.329), and amputation rates were 22% (n=8) versus 32% (n=11; P =0.618) in the DA+DCB group and the DCB group, respectively. Conclusions: Treatment of long infrapopliteal artery lesions with DA+DCB versus DCB alone leads to comparable clinical and technical results at 6 months and 1 year. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01763476.

Comparison and Analysis between the NAV6 Embolic Protection Filter and SpiderFX EPD Filter in Superficial Femoral Artery Lesions

Objective. To compare the safety and efficacy between the SpiderFX EPD and Emboshield NAV6 filter in the collection of embolic debris created from lower limb atherectomy procedures in patients with PAD. Materials and Methods. Between January 2014 and October 2015, 507 patients with symptomatic peripheral artery disease were treated with directional atherectomy (SilverHawk), rotational atherectomy (JetStream), or laser atherectomy (Turbo Elite) based on operator discretion. Emboshield NAV6 (n = 161) and SpiderFX (n = 346) embolic protection devices were used with each of the 3 atherectomy devices. The primary study endpoint was 30-day freedom from major adverse events (MAEs). An MAE was defined as death, MI, TVR, thrombosis, dissection, distal embolization, perforation at the level of the filter, and unplanned amputation. A descriptive comparison of the MAE rates between Emboshield NAV6 and SpiderFX embolic protection devices was conducted. Results. The freedom from major adverse event (MAE) rate was 92.0% (CI: 86.7%, 95.7%) in patients who received an Emboshield NAV6 filter compared to 91.6% (CI: 88.2%, 94.3%) in patients who received the SpiderFX filter ( p = 0.434 ). The lower limit of 86.7% freedom from major adverse event rate in the Emboshield NAV6 group was above the performance goal of 83% ( p < 0.0008 ). Conclusions. There were no significant clinical outcome differences between Emboshield NAV6 and SpiderFX EPD filters in the treatment of lower extremities. This evaluation indicates the safety and efficacy to use either filter device to treat PAD patients with lower extremity lesions.

Improving the diagnostic yield of biliary stricture biopsies using a directional atherectomy device.

e16167 Background: Diagnosing the pathologic etiology of biliary strictures presents challenges that have been well-documented. Accuracy of traditional brushing and fine needle aspirate techniques range from 44% to 73%.2 Over the last 2 decades the use of atherectomy catheter biliary biopsy has demonstrated high sensitivity and positive predictive values with a low complication rate. This endoluminal approach allows for larger volume histologic samples, allowing for the potential to obtain adequate tissue for next generation sequencing (NGS). The aim of this retrospective review of a single-center’s experience was to define the accuracy, ease of evaluation, and the ability to obtain NGS for personalized treatment. Methods: A retrospective review was performed under a waiver from the Institutional Review Board. A search of medical records from 1/2016 to 2/2021 yielded 20 biopsies in 19 patients. The 20 biopsies were completed by 4 interventional radiologists with between 2-11 years of experience. All available samples were analysed by a pathologist with greater than 10 years of experience and graded for adequacy and feasibility of NGS. Results: The patient population was 53% female with average age of 65.1 years. 12/19 (63%) patients had prior non-atherectomy biopsy attempts. The average ease of evaluation score for the 19 biopsies was 7.8/9, compared to 6.2/9 for the brushing specimens obtained from a subset of the same patients. Seven biopsies were positive for malignancy, ten were benign and three were non-diagnostic. The 7 biopsies that rendered a definitive diagnosis of malignancy had an average ease of evaluation score 8.7/9. The overall accuracy rate was 78.9%, and 71% of malignant samples were deemed adequate for NGS. There were two biopsy related complications; one pseudoaneurysm treated with embolization and one biliary drain dislodgement. Conclusions: Biliary biopsy using an atherectomy device has similar accuracy to traditional techniques; however, it allows for improved diagnostic yield and increased tissue specimen with 71% of samples adequate for NGS testing.

Safety and outcomes of combined carbon dioxide angiography and OCT-guided femoro-popliteal chronic total occlusion crossing and directional atherectomy in patients with chronic kidney disease

Background Carbon dioxide angiography with addition of optical coherence tomography imaging may improve procedural success and clinical outcomes in patients with peripheral artery disease and chronic kidney disease. Methods Single-center, retrospective analysis of patients with chronic kidney disease who underwent carbon dioxide angiography and optical coherence tomography-guided chronic total occlusion crossing and/or optical coherence tomography-guided directional atherectomy was performed. Patient and procedure-related characteristics, along with peri- and one-year post-procedural major adverse events, were analyzed. Results A total of 18 vessels in 11 patients, with mean age 70 years were treated. All had co-morbidities such as hypertension, hyperlipidemia, had history or were current smokers with baseline peripheral artery disease. Majority were diabetic with coronary disease (82%); 55% baseline chronic kidney disease IV, 55% Rutherford class III and 45% class IV. Contrast was used in only two patients. Mean total fluoroscopy time and radiation dose was 24.1 min and 249.2 mGY, respectively. Half of the lesions were femoro-popliteal chronic total occlusions, and Ocelot catheter was used to cross seven of nine chronic total occlusions and was successful in six. Adjunctive optical coherence tomography-guided directional atherectomy was performed in 8 of 11 patients. Only two adverse events occurred: one clinically significant event of slow-flow intra-procedurally and one target limb revascularization within one year of index procedure in a vessel different than prior treated. Optical coherence tomography imaging in both chronic total occlusion-crossing and atherectomy resulted in 10-min mean fluoroscopy reduction time and 32 mGY reduction in radiation dose. Conclusion Carbon dioxide angiography with the addition of optical coherence tomography imaging for chronic total occlusion crossing and/or optical coherence tomography-guided directional atherectomy reduced the need for contrast agents, total fluoroscopy time, and radiation exposure in patients with peripheral artery disease and baseline chronic kidney disease.

The role of directional atherectomy in critical-limb ischemia

Background: Our aim was to review the current literature of the use of directional atherectomy (DA) in the treatment of lower extremity critical-limb ischemia. Methods: A search for relevant literature was performed in PubMed and PubMed Central on 16 April 2020, sorted by best match. Three searches across two databases were performed. Articles were included that contained clinical and procedural data of DA interventions in lower extremity critical-limb ischemia patients. All studies that were systematic reviews were excluded. Results: Eleven papers were included in this review. Papers were examined under several parameters: primary patency and secondary patency, limb salvage/amputation, technical/procedural success, complications/periprocedural events, and mean lesion length. Primary and secondary patency rates ranged from 56.3% to 95.0% and 76.4% to 100%, respectively. Limb salvage rates ranged from 69% to 100%. Lesion lengths were highly varied, representing a broad population, ranging from 30 ± 33 mm to 142.4 ± 107.9 mm. Conclusions: DA may be a useful tool in the treatment of lower extremity critical-limb ischemia.