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

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

Technical outcomes of below-the-elbow revascularization for upper extremity critical limb ischemia.

OBJECTIVES: This study aims to report the technical results of below-the-elbow arterial revascularization in patients with critical hand ischemia. METHODS: We retrospectively identified upper extremity critical limb ischemia patients treated with below-the-elbow arterial intervention between 2013 and 2017. Patient demographics, comorbidities, and procedural data were reviewed and technical success was evaluated. RESULTS: Seven patients with 12 arteries that were affected by critical hand ischemia were treated. All patients had a history of end-stage renal disease. The technical success rate was 83.3%. There were no major or minor complications. The average follow-up duration was 9 months (2-26 months). One patient underwent a digital amputation at 8 months. CONCLUSION: Arterial revascularization of the below-the-elbow arteries for critical hand ischemia is safe and technically feasible.

Hemodialysis Access Maintenance in the Medicare Population: An Analysis Over a Decade of Trends by Provider Specialty and Site of Service.

PURPOSE: To evaluate annual national trends in hemodialysis access maintenance procedures in the Medicare population by specialty and setting. METHODS: Medicare Physician Supplier Procedure Summary Master Files between 2005 and 2015 were analyzed for procedure codes of hemodialysis access angiography and percutaneous thrombectomy. Using physician specialty codes, component procedure volume for endovascular services were queried for radiology, medicine, and surgery. Data entries were analyzed by provider specialty and place of service. Average submitted and allowed charges per intervention were extracted. Linear regression modeling was used to identify trends in number of and allowed charges by specialty and practice setting. RESULTS: Between 2005 and 2015, the frequency of dialysis access angiography for Medicare fee-for-service beneficiaries increased by a total of 74.71% (211,181 to 368,955). Specialty-specific analysis demonstrated volume increases of 220.21% (22,128 to 101,109) for surgery, 249.02% (32,690 to 114,094) for medicine, and 2.81% (135,564 to 139, 367) for radiology. By 2015, an increased trend from hospital-based to non-hospital-based procedures associated with significantly higher reimbursement rates to providers (+18,798 non-hospital-based cases/year, $46.95/year, P ≤ .001) was also observed, with medicine performing the highest volume of non-hospital-based procedures. In this period, there was also a modest total overall increase of percutaneous thrombectomy procedures by 7.75% (61,485 to 66,250). CONCLUSIONS: The frequency of endovascular hemodialysis access maintenance procedures in the Medicare fee-for-service program has increased from 2005 to 2015, with the majority market share transitioning from radiologists to non-radiologists. Similarly, most access maintenance in this time period changed from hospital-based to non-hospital-based interventions.

Combination Ipsilateral Lobar and Segmental Radioembolization Using Glass Yttrium-90 Microspheres for Treatment of Multifocal Hepatic Malignancies.

Eight patients with primary (n = 6) and metastatic (n = 2) disease of the liver underwent yttrium-90 radioembolization with glass microspheres using a combination of segmental and ipsilateral lobar approach to treat multifocal tumors containing a single dominant tumor. The superselective dose was administered to the dominant tumor, whereas lobar infusion was used for smaller tumors. Assuming uniform distribution, median dose to the segment with dominant tumor was 412.3 Gy and to the remaining lobe was 117.5 Gy. No instances of radiation-induced liver disease occurred. Combined segmental and ipsilateral lobar radioembolization is a well-tolerated procedure to treat unilateral multifocal hepatic tumors including a single dominant tumor.

Intrahepatic Cholangiocarcinoma Treated with Transarterial Yttrium-90 Glass Microsphere Radioembolization: Results of a Single Institution Retrospective Study.

PURPOSE: To evaluate the efficacy and safety of transarterial yttrium-90 glass microsphere radioembolization in patients with unresectable intrahepatic cholangiocarcinoma (ICC). MATERIALS AND METHODS: Retrospective review of 85 consecutive patients (41 men and 44 women; age, 73.4 ± 9.3 years) was performed. Survival data were analyzed by the Kaplan-Meier method, Cox regression models, and the log-rank test. RESULTS: Median overall survival (OS) from diagnosis was 21.4 months (95% confidence interval [CI]: 16.6-28.4); median OS from radioembolization was 12.0 months (95% CI: 8.0-15.2). Seven episodes of severe toxicity occurred. At 3 months, 6.2% of patients had partial response, 64.2% had stable disease, and 29.6% had progressive disease. Median OS from radioembolization was significantly longer in patients with Eastern Cooperative Oncology Group (ECOG) scores of 0 and 1 than patients with an ECOG score of 2 (18.5 vs 5.5 months, P = .0012), and median OS from radioembolization was significantly longer in patients with well-differentiated histology than patients with poorly differentiated histology (18.6 vs 9.7 months, P = .012). Patients with solitary tumors had significantly longer median OS from radioembolization than patients with multifocal disease (25 vs. 6.1 months, P = .006). The absence of extrahepatic metastasis was associated with significantly increased median OS (15.2 vs. 6.8 months, P = .003). Increased time from diagnosis to radioembolization was a negative predictor of OS. The morphology of the tumor (mass-forming or infiltrative, hyper- or hypo-enhancing) had no effect on survival. Post-treatment increased cancer antigen 19-9 level, increased international normalized ratio, decreased albumin, increased bilirubin, increased aspartate aminotransferase, and increased Model for End-Stage Liver Disease score were significant predictors of decreased OS. CONCLUSIONS: These data support the therapeutic role of radioembolization for the treatment of unresectable ICC with good efficacy and an acceptable safety profile.

Laparoscopy has a superior diagnostic yield than percutaneous image-guided biopsy for suspected intra-abdominal lymphoma.

INTRODUCTION: To date, no study has compared laparoscopy (LB) to percutaneous (PB) biopsy for the diagnosis of abdominal lymphoma. The objective of this study is to compare the success rate and safety profile of laparoscopic lymph node biopsy to the percutaneous approach in patients with intra-abdominal lymphadenopathy concerning for lymphoma. MATERIALS AND METHODS: We performed a multi-institution, retrospective review of patients undergoing lymph node biopsy for suspected intra-abdominal lymphoma between 2005 and 2013. Our primary outcome was adequate tissue yield between the two techniques, both for histologic diagnosis and for ancillary studies such as flow cytometry. Secondary outcomes included 30-day morbidity, 30-day readmission rates, the need for additional lymph node biopsy procedures, and length of stay. RESULTS: All 34 of the LB patients had adequate specimen for histologic diagnosis compared to 92.3% of patients with a PB (p = 0.18). Significantly more patients in the LB group had sufficient tissue for ancillary studies when needed than in the PB group, 95.5 and 68.2%, respectively (p = 0.04). A second biopsy was pursued in 23.1% of failed PB patients, 0% with success on second attempt. DISCUSSION: When index of suspicion is high or when biopsy is performed for patient previously diagnosed with lymphoma and recurrence/transformation is suspected, LB safely and consistently provides adequate tissue for initial diagnosis and for ancillary studies. In contrast, image-guided PB may be more appropriate for patients for whom ancillary studies are unlikely to add to planned treatments or when there is a high risk of complications from either general anesthesia or patient comorbidities.

Outcomes of patients with acute upper gastrointestinal nonvariceal hemorrhage referred to interventional radiology for potential embolotherapy.

PURPOSE: To report the outcomes following catheter angiography with or without embolization in patients with acute upper gastrointestinal nonvariceal hemorrhage (UGINH). MATERIALS AND METHODS: A review of electronic medical records was performed to identify all potential patients for this study between 2001 and 2011. Patients with first-time UGINH who required angiographic localization and endovascular treatment were included. Patients with variceal bleeding and prior surgical or endovascular intervention for the gastrointestinal system were excluded. Society of Interventional Radiology guidelines and American College of Radiology "appropriateness criteria" reporting standards were followed. RESULTS: We identified 74 patients (men/women=46/28) with a mean age of 60 years. Thirty-four patients were found to have active bleeding on angiography. One patient from this group did not undergo embolization because of an angiographic diagnosis of aortoenteric fistula. Technical failure was encountered in 2/34 patients; therefore, the technical success of embolization was 94%. Forty of 74 patients showed no angiographic evidence of active bleeding; 18 patients underwent prophylactic embolization using endoscopically placed clips as targets; and 22 patients had no embolotherapy. Thus, we grouped the patients into 3 groups: (1) therapeutic embolization; (2) prophylactic/empiric embolization; and (3) no embolotherapy groups. The clinical success of embolization was 67% to 68% in the therapeutic embolization group and 67% in the prophylactic embolization group. Early rebleeding rates were 33.8%, 51.6%, 33.3%, and 12% among all the patients, the therapeutic embolization group, the prophylactic embolization group, and the no endovascular treatment group, respectively. Mortality was significantly high in patients with advanced age (P=0.001), cerebrovascular disorders (P=0.037), and positive angiography (P=0.026), even when clinical success was achieved. CONCLUSIONS: Acute UGINH remains a clinical challenge with increased mortality rates, even with high technical success rates. Patients with negative findings on angiography have lower early rebleeding rates than patients with active bleeding during angiography or endoscopy-guided prophylactic/empiric embolization.

How to Approach Below-the-Ankle Arterial Interventions.

Critical limb ischemia, also referred to as chronic limb-threatening ischemia, is a major medical problem leading to limb amputations if not managed properly with a multispecialty team. Establishment of sufficient arterial flow to the foot is an integral part of this care. During the past two to three decades, arterial revascularization has become primarily endovascular with open surgical approaches significantly diminished in comparison. As techniques, tools, and experiences of the interventionalist have improved, the ability to recanalize more complex lesions has become more commonplace. We are at an age that even the arteries below the ankle can be accessed for complex interventions and even be recanalized if necessary. This article will discuss common arterial interventions performed below the ankle.

Chronic mesenteric ischaemia: 28-year experience of endovascular treatment.

OBJECTIVE: To report the outcomes associated with endovascular therapy for patients with chronic mesenteric ischemia (CMI). METHODS: A retrospective review of patients who underwent endovascular therapy for CMI between April 1981 and September 2009 at a single institution was performed. Procedural details, mesenteric arteries treated, technical and clinical success rates, outcomes per patient and per vessel were assessed. RESULTS: In 166 patients treatment was attempted using a variety of balloon and stent platforms during the 28-year period. The technical success rate was 97% per patient and 94% per vessel. The technical success rate of stenting (99.4%) was higher than for percutaneous transluminal angioplasty (PTA; 86%; P = 0.0001). Immediate clinical improvement was seen in 146 out of 166 (88.2%). The type of guidewire or device platform, brachial vs. femoral artery access, balloon and/or stent diameters used, and stenosis vs. occlusion had no statistical impact on mortality or the primary patency of any mesenteric artery outcomes. The outcome of the superior mesenteric artery (SMA) with PTA appears to be superior to that of stenting (P = 0.014). CONCLUSION: Technical success rates are improved with the use of stents; however, PTA use in the SMA seems to offer better primary patency rates. KEY POINTS: • Superior mesenteric artery (SMA) stenosis is often responsible for ischaemic symptoms. • Treatment with percutaneous transluminal angioplasty (PTA) seems superior to stenting • Although technical success rates are improved with the use of stents. • Higher mortality in the elderly and those presenting with nausea/vomiting/bloody stools.

Prevalence, presentation, and endovascular management of hemodynamically or clinically significant arterio-portal fistulae in living and cadaveric donor liver transplant recipients.

PURPOSE: To compare the prevalence (cadaveric vs. living donor transplants), clinical features, and the effectiveness of endovascular management of significant arterio-portal fistulae (APF) in liver transplant recipients. METHODS: A retrospective audit of liver transplant recipients in two institutions was performed (1996-2009). Significant APF were included and were defined as symptomatic and/or hemodynamically significant (causing graft dysfunction and/or having abnormal Doppler findings in the portal vein). Patients with significant APF were evaluated for presenting symptoms, imaging features, size/branch order portal vein involvement, and effectiveness of the endovascular management (coil embolization). RESULTS: Four significant APF were found in 1992 (0.2%) liver transplants. Two were symptomatic and two were asymptomatic but were hemodynamically significant with liver function test abnormalities. All four APF were found in cadaveric donor graft recipients (0.23%, N = 4/1753) and none in 239 living donor graft recipients. However, there was no statistical difference between cadaveric and living donor graft recipients (p = 1.0, odds ratio = 1.23). Coil embolization was technically and clinically successful in all 4 without complications and causing normalization of the abnormal Doppler findings. CONCLUSION: Significant APF are a rare diagnosis (0.2% of transplants). Coil embolization is a safe and effective treatment option for APF in transplants.

Management of Central Venous Stenosis and Occlusion in Dialysis Patients.

Central venous occlusions (CVOs) of the major intrathoracic veins (jugular, subclavian, brachiocephalic, superior vena cava) can cause debilitating symptoms, negatively impact arteriovenous fistula/graft function, or limit potential access creation options in end-stage kidney disease (ESKD) utilizing hemodialysis (HD). This review summarizes the incidence, pathophysiology, indications/contraindications, and management options of CVOs in the ESKD on HD population and concludes with considerations and examples when planning endovascular central recanalization procedures, which have risen as the first-line management when appropriate.

HeRO Graft: Indications, Technique, Outcomes, and Secondary Intervention.

The Hemodialysis Reliable Outflow (HeRO) graft is a nontraditional, surgical, and endovascularly placed access that offers options in failing arteriovenous fistula/arteriovenous graft or catheter-dependent patients. The HeRO graft provides a unique option and is specifically referred to in the 2019 Kidney Disease Outcomes Quality Initiative (KDOQI) vascular access update. The interventional radiologist has a role and opportunity to work collaboratively with surgeons in assisting with (1) the identification, selection, preparation for, and placement of HeRO grafts and (2) providing post-placement maintenance to ensure long-term patency.

Outcomes of covered kissing stent placement compared with bare metal stent placement in the treatment of atherosclerotic occlusive disease at the aortic bifurcation.

PURPOSE: To review the outcomes with the use of balloon-expandable covered iliac kissing stents as compared with bare metal stents in the treatment of atherosclerotic disease at the aortic bifurcation. MATERIALS AND METHODS: A review of consecutive patients from a single institution with atherosclerotic occlusive disease at the aortic bifurcation treated with balloon-expandable kissing stents was performed between January 1, 2002, and September 1, 2007. Fifty-four patients were identified and divided into two groups: those with bare metal stents and those with covered stents. Technical and clinical success (Fontaine classification), complications, and patency at follow-up were documented. RESULTS: Twenty-six patients (17 men, nine women; mean age, 61 years; age range, 39-79 years) received covered stents and 28 patients (15 men, 13 women; mean age, 61 years; age range, 38-82 years) received bare metal stents. Technical success was achieved in 100% of patients in both groups. Major complications occurred in three of the 26 (11%) with covered stents (P = .66) and two of the 28 patients (7%) with bare metal stents. The median follow-up was 21 months (20 months for covered stents vs 25 months for bare metal stents; range, 1-62 months). Twenty-two of the 26 patients (85%) with covered stents had sustained improvement in clinical symptoms during the follow-up period compared with 15 of the 28 patients (54%) with bare metal stents (P = .02). Primary patency rates at 1 and 2 years were 92% and 92%, respectively, for covered stents and 78% and 62% for bare metal stents (P = .023). CONCLUSIONS: The use of covered balloon-expandable kissing stents for atherosclerotic aortic bifurcation occlusive disease provides superior patency at 2 years as compared with bare metal balloon-expandable stents.