James F. Benenati

Initial experience with use of tris-acryl gelatin microspheres for uterine artery embolization for leiomyomata.

PURPOSEnTo assess the safety and effectiveness of tris-acryl gelatin microspheres (Embospheres) in the treatment of leiomyomata by uterine artery embolization.nnnMATERIALS AND METHODSnThis was a Phase I study of 30 patients with symptomatic leiomyomata. Each patient underwent ultrasound imaging and completed questionnaires regarding symptoms and health status at baseline and 3 and 6 months after treatment. Bilateral embolization was performed with use of tris-acryl gelatin microspheres. Summary statistics were used to characterize the demographic and procedure data. Paired t-tests were used to assess change in the severity of menstrual bleeding and health-related quality of life.nnnRESULTSnBilateral embolization was technically successful in all patients. Three months after treatment, menstrual bleeding was markedly improved as assessed by menorrhagia questionnaire (P <.0001) and menstrual calendar (P <.0001). Pelvic pain and discomfort was improved in 92% of cases. Physical component summary scores of the SF-12 also increased from baseline at 3 months (P =.02) and at 6 months (P =.01). Minor complications occurred in nine patients; there were no major complications.nnnCONCLUSIONnAlthough limited, this initial experience suggests that tris-acryl gelatin microspheres are an effective and safe embolic agent for the treatment of uterine leiomyomata.

Initial results of reteplase in the treatment of acute lower extremity arterial occlusions.

PURPOSEnTo assess the feasibility and efficacy of reteplase in transcatheter arterial thrombolysis for lower extremity occlusive disease.nnnMATERIALS AND METHODSnFifteen consecutive patients with acute lower extremity ischemia due to occlusive disease were treated by means of catheter-directed thrombolysis with reteplase. Following diagnostic angiography, thrombolysis was started either from an antegrade puncture site in cases of femoropopliteal occlusions, or from the contralateral groin in cases of thrombosis of the iliac artery, common femoral artery, or infrainguinal bypass grafts. Reteplase was infused at a rate of either 0.5 U/h (six patients) or 1.0 U/h (nine patients).nnnRESULTSnComplete thrombolysis was achieved in all of the nine (100%) patients in the 1.0 U/h group and in four of six (66%) patients in the 0.5 U/h group for a combined success rate of 13 of 15 (87%). Clinical success was achieved in 11 of 15 patients overall (73%). Major bleeding complications occurred in none of the 9 patients in the 1.0 U/h group and in one (16%) of the six patients in the 0.5 U/h group for an overall rate of 6%.nnnCONCLUSIONSnReteplase shows promise as an alternative to urokinase in the treatment of lower extremity ischemia due to arterial occlusive disease.

Percutaneous angioplasty for atherosclerotic renal artery disease: Effect on renal function in azotemic patients

PurposeWe studied the effect of percutaneous transluminal renal angioplasty (PTRA) on renal function in azotemic patients with atherosclerotic renal artery stenosis.MethodsThe results of PTRA were analyzed retrospectively in 40 patients. There were 61 stenoses, 54 of which received balloon angioplasty; 7 had stent placement during the initial procedure, 6 for recurrent stenosis 6–18 months after PTRA.ResultsTechnical success was achieved in 95% of cases. The complication rate was 15%, compared to 6% in nonazotemic patients. Mean creatinine rose from 1.9 ± 0.15 mg/dl (mean ± SEM) to 2.4 ± 0.17 mg/dl during the year before PTRA, stabilizing at 2.5 ± 0.57 mg/ dl for 1 year after PTRA. PTRA was clinically successful in 60% of patients; 40% showed further deterioration of renal function. Clinical failure was associated with residual renal artery stenosis and presence of intermittent claudication.ConclusionWe conclude that PTRA helps salvage renal function in patients with azotemia and atherosclerotic renal artery stenosis.

Direct percutaneous sac injection for postoperative endoleak treatment after endovascular aortic aneurysm repair

BACKGROUNDnThis study presents the short-term and midterm results of direct percutaneous sac injection (DPSI) for postoperative endoleak treatment after endovascular aortic aneurysm repair (EVAR).nnnMETHODSnBetween March 1994 and November 2011, EVAR was performed in 986 patients. The median follow-up was 63 ± 45 months (range, 0-211 months). A retrospective analysis was performed. DPSI was used in 21 patients for 19 type II endoleaks and two endoleaks of undefined origin (EOUO), of which 12 (57%) were after failure of a previous endovascular treatment attempt.nnnRESULTSnDPSI using thrombin (n = 16), coils (n = 7), gelfoam (n = 6), or glue (n = 3), or a combination, was technically feasible in all patients. Saccography during DPSI revealed a previously undetected type I endoleak in three patients. Immediate DPSI success was achieved in 16 of 18 procedures (88.9%), with two complications. Glue incidentally intravasated in the inferior vena cava, causing a clinically nonsignificant subsegmental pulmonary artery embolism in one patient, and the temporary development of a type III endoleak, possibly from graft puncture, in another. During a median follow-up of 39 months (interquartile range, 13-88 months) after DPSI, recurrent endoleaks were observed in nine patients (50.0%), one type I endoleak due to graft migration, five type II endoleaks, and three EOUO. The occurrence of a re-endoleak during follow-up was significantly associated with dual-antiplatelet medication (0% in patients without re-endoleak vs 44.4% in patients with re-endoleak; P = .023) and with a nonsignificant trend for the use of aspirin alone (33.3% in patients without re-endoleak vs 80% in patients with re-endoleak; P = .094). Re-endoleak occurred in 33.3% of the patients without antiplatelet medication and in 100% of patients with dual-antiplatelet medication (P = .026). Thrombin was used as the sole embolic agent during the initial DPSI in all patients with dual-antiplatelet therapy. No other factor was significantly associated with re-endoleaks. Reintervention was deemed necessary in six patients within a median of 10 months (interquartile range, 4-16 months) after DPSI, including six additional DPSI treatments in four patients with type II re-endoleaks, cuff placements in one type I endoleak, and endograft relining in one EOUO.nnnCONCLUSIONSnThis initial experience suggests that DPSI is feasible as a technique for endoleak treatment after EVAR. However, complications and endoleak recurrence remain a concern. The role of antiplatelet therapy and different embolic agents on long-term embolization success needs to be studied in more detail.

Current Clinical Practice in Postoperative Endovascular Aneurysm Repair Imaging Surveillance

PURPOSEnTo investigate the current clinical practice in postoperative endovascular aneurysm repair (EVAR) imaging surveillance.nnnMATERIALS AND METHODSnCorresponding authors of EVAR publications during the years 2006-2011 and subscribers to an endovascular journal were invited to complete a 27-question online survey related to institutional demographics, standard post-EVAR imaging surveillance, and imaging protocols in special circumstances (eg, renal insufficiency).nnnRESULTSnThe survey was completed by 515 of 9,631 physicians performing EVAR from 52 countries. Of respondents, 65.3% were affiliated with experienced centers where EVAR has been performed for > 10 years or with > 50 EVAR procedures performed per year. Computed tomography (CT) angiography was the modality used most often for standard surveillance with a maximum time interval between studies of 12 months in 78.8% of centers out to 5 years. Experienced centers were more likely to delay follow-up imaging to 1 year after an unremarkable initial post-EVAR imaging study (P < .001), to extend surveillance intervals > 12 months (P = .043), and to use ultrasound (P < .01) for surveillance. After the detection of a type II endoleak, CT angiography was favored for follow-up by 59.4% of the respondents. Experienced centers were more likely to favor ultrasound (P = .006) and to schedule this follow-up examination later (after 6-12 months, P < .001). Of respondents, 62.8% used a glomerular filtration rate threshold of < 30 mL/min for not performing contrast-enhanced CT scan. In patients with renal insufficiency, most respondents performed ultrasound with or without a concomitant noncontrast CT scan.nnnCONCLUSIONSnCT is the most frequently used method of long-term surveillance after EVAR. Use of ultrasound for long-term surveillance, extension of follow-up time intervals, or both were most often reported in experienced centers.

The Effect of Realtime Monitoring on Dose Exposure to Staff Within an Interventional Radiology Setting

PurposeThe purpose of this study is to evaluate a new device providing real-time monitoring on radiation exposure during fluoroscopy procedures intending to reduce radiation in an interventional radiology setting.Materials and MethodsIn one interventional suite, a new system providing a real-time radiation dose display and five individual wireless dosimeters were installed. The five dosimeters were worn by the attending, fellow, nurse, technician, and anesthesiologist for every procedure taking place in that suite. During the first 6-week interval the dose display was off (closed phase) and activated thereafter, for a 6-week learning phase (learning phase) and a 10-week open phase (open phase). During these phases, the staff dose and the individual dose for each procedure were recorded from the wireless dosimeter and correlated with the fluoroscopy time. Further subanalysis for dose exposure included diagnostic versus interventional as well as short (<10xa0min) versus long (>10xa0min) procedures.ResultsA total of 252 procedures were performed (nxa0=xa088 closed phase, nxa0=xa050 learning phase, nxa0=xa0114 open phase). The overall mean staff dose per fluoroscopic minute was 42.79 versus 19.81xa0µSv/min (pxa0<xa00.05) comparing the closed and open phase. Thereby, anesthesiologists were the only individuals attaining a significant dose reduction during open phase 16.9 versus 8.86xa0µSv/min (pxa0<xa00.05). Furthermore, a significant reduction of total staff dose was observed for short 51xa0% and interventional procedures 45xa0% (pxa0<xa00.05, for both).ConclusionA real-time qualitative display of radiation exposure may reduce team radiation dose. The process may take a few weeks during the learning phase but appears sustained, thereafter.

Technical Results of Vacuum-Assisted Thrombectomy for Arterial Clot Removal in Patients with Acute Limb Ischemia

PURPOSEnTo assess the efficacy and safety of a vacuum-assisted thrombectomy (VAT) catheter system for treating patients with acute limb ischemia (ALI).nnnMATERIALS AND METHODSnA retrospective study evaluated VAT systems (Penumbra, Alameda, California) in a consecutive series of 30 patients with ALI. ALI was defined as clinical symptoms within 2 weeks of presentation. The primary endpoint was improvement in blood flow across a lesion by improvement in Thrombolysis in Myocardial Infarction (TIMI) score that was adapted to peripheral arteries. Concomitant balloon angioplasty or stent placement in addition to VAT was considered a complementary treatment. Additional thrombectomy treatments, such as thrombolysis and mechanical thrombectomy, were considered technical failures. Target lesions were grouped anatomically into above-the-knee (ATK) or below-the-knee (BTK) lesions.nnnRESULTSnIn 30 patients, 33 lesions (ATK, n = 13; BTK, n = 20) were treated. No complications were attributed to the VAT systems. The primary endpoint was obtained in 24/33 (72.7%) lesions (BTK, 17/20 [85.0%]; ATK, 7/13 [53.9%]; P = .050 by χ(2) test). TIMI scores were similar at baseline but differed after VAT between the ATK and BTK groups (P < .025 by t test). ATK lesions required more concomitant angioplasty or stent placement, or both (P < .015 by χ(2) test).nnnCONCLUSIONSnVAT is a safe, technically successful short-term therapeutic option for thrombus removal in patients with ALI.

Comparative Effectiveness of Carotid Artery Stenting Versus Carotid Endarterectomy Among Medicare Beneficiaries

Background—Effectiveness of carotid artery stenting (CAS) relative to carotid endarterectomy (CEA) among Medicare patients has not been established. We compared effectiveness of CAS versus CEA among Medicare beneficiaries. Methods and Results—We linked Medicare data (2000–2009) to the Society for Vascular Surgery’s Vascular Registry (2005–2008) and the National Cardiovascular Data Registrys (NCDR) Carotid Artery Revascularization and Endarterectomy Registry (2006–2008/2009). Medicare patients were followed up from procedure date until death, stroke/transient ischemic attack, periprocedural myocardial infarction, or a composite end point for these outcomes. We derived high-dimensional propensity scores using registry and Medicare data to control for patient factors and adjusted for provider factors in a Cox regression model comparing CAS with CEA. Among 5254 Society for Vascular Surgery’s Vascular Registry (1999 CAS; 3255 CEA) and 4055 Carotid Artery Revascularization and Endarterectomy Registry (2824 CAS; 1231 CEA) Medicare patients, CAS patients had a higher comorbidity burden and were more likely to be at high surgical risk (Society for Vascular Surgery’s Vascular Registry: 96.7% versus 44.5%; Carotid Artery Revascularization and Endarterectomy Registry: 71.3% versus 44.7%). Unadjusted outcome risks were higher for CAS. Mortality risks remained elevated for CAS after adjusting for patient-level factors (hazard ratio, 1.24; 95% confidence interval, 1.06–1.46). After further adjustment for provider factors, differences between CAS and CEA were attenuated or no longer present (hazard ratio for mortality, 1.13; 95% confidence interval, 0.94–1.37). Performance was comparable across subgroups defined by sex and degree of carotid stenosis, but there was a nonsignificant trend suggesting a higher risk of adverse outcomes in older (>80) and symptomatic patients undergoing CAS. Conclusions—Outcomes after CAS and CEA among Medicare beneficiaries were comparable after adjusting for both patient- and provider-level factors.

Drug-coated balloons to improve femoropopliteal artery patency: Rationale and design of the LEVANT 2 trial

BACKGROUNDnAtherosclerotic peripheral artery disease (PAD) is common and results in limitations in quality of life and potential progression to limb loss. Options for therapy include medical therapy, supervised exercise, surgical revascularization, and, more recently, endovascular therapies to restore arterial perfusion to the limb. Endovascular revascularization has evolved over the past 2 decades, from percutaneous transluminal angioplasty (PTA) to self-expanding stents, atherectomy, laser angioplasty, and drug-eluting stents. Despite impressive technologic advances, PTA remains the standard of care at many institutions and is the recommended primary treatment modality for femoral-popliteal PAD according to current American College of Cardiology Foundation/American Heart Association guidelines. However, restenosis after PTA is common. Therefore, a significant clinical need remains for a device that is able to achieve more durable patency than PTA but does not require a permanent implant. Drug-coated balloons (DCBs) have the potential to address this need. Several randomized controlled clinical trials of PTA balloons coated with different formulations of paclitaxel have been conducted in Europe (N Engl J Med 2008;358:689-699) (Circulation 2008;118:1358-1365) (Circ Cardiovasc Interv 2012;5:831-840) (JACC Cardiovas Interv 2014;7:10-19) and demonstrated more durable efficacy than PTA with comparable safety. These studies were limited by small sample sizes and powered solely for an angiographic primary end point. The pivotal LEVANT 2 trial was designed in collaboration with the US Food and Drug Administration to demonstrate safety and efficacy in a large population and to obtain US Food and Drug Administration approval.nnnMETHODSnA prospective, multicenter, single-blind trial comparing the Lutonix DCB (Bard Lutonix; New Hope, MN) versus PTA for treatment of femoropopliteal PAD (LEVANT 2) is the first US-based 2:1 randomized controlled trial of 476 patients with femoral-popliteal PAD designed to demonstrate superior efficacy and noninferior safety of a novel paclitaxel DCB compared with PTA. The primary efficacy end point is primary patency at 12 months. The primary safety end point is composite freedom at 12 months from perioperative death, index limb amputation, reintervention, and limb-related mortality. A series of important secondary end points include physical functioning, quality of life, revascularizations, and alternative measures of patency. To minimize bias potential for confounding variables, LEVANT 2 (1) excluded patients stented after predilation before randomization, (2) incorporated very stringent criteria for bailout stenting, (3) did not count bailout stenting as a target lesion revascularization or failure of any end point, (4) required a blinded clinician to perform clinical evaluations at follow-up, and (5) required clinical assessment before review of duplex ultrasound results.nnnCONCLUSIONSnLEVANT 2 represents the first US-inclusive multicenter, randomized controlled trial to assess the safety and efficacy of a novel DCB compared with PTA as primary therapy for symptomatic PAD on the background of standard medical therapy.

Ultrasound-Accelerated versus Standard Catheter-Directed Thrombolysis in 102 Patients with Acute and Subacute Limb Ischemia

PURPOSEnTo compare the safety and efficacy of ultrasound-accelerated thrombolysis (UAT) and standard catheter-directed thrombolysis (CDT) in patients with acute and subacute limb ischemia.nnnMATERIALS AND METHODSnMedical records of all patients treated with thrombolysis for acute and subacute limb ischemia between August 2005 and January 2012 were reviewed. Coprimary (increase in ankle-brachial index, degree of lysis) and secondary endpoints (technical success, distal embolization, bleeding complications, need for additional interventions) were assessed. UAT was performed in 75 patients, and CDT was performed in 27 patients. Patients baseline demographic and clinical parameters and procedure details, including lytic drug infusion rate (P = .704 and P = .987), total infusion time (P = .787 and P = .377), and use of adjunctive procedures (P = .457), did not differ significantly between the two groups.nnnRESULTSnComplete lysis was achieved in 72.0% (UAT) and 63.0% (CDT) of patients (P = .542); hemodynamic success was achieved in 91.8% (UAT) and 92.3% (CDT) (P = .956). Overall major and minor bleeding complications were observed in 6.9% (UAT) and 3.9% (CDT) of patients. Major (P = .075) and minor (P = .276) bleeding independently did not differ between UAT and CDT. Major and minor bleeding combined was lower: 6.7% (UAT) versus 22.2% (CDT) (P = .025). Overall target vessel patency after 8.0 months (range, 1.5-20.5 mo) was 73.5%; target vessel patency for UAT was 75.9% versus 64.3% for CDT (P = .379). Median long-term survival was not significantly different between UAT and CDT: 3.6 years (range, 2.42-5.33 y) versus 1.8 years (range, 1.33-4.92 y) (P = .061).nnnCONCLUSIONSnBoth UAT and CDT are safe and efficient treatment modalities for patients with acute and subacute limb ischemia. The observed lower risk of total bleeding for UAT versus CDT may warrant prospective comparative trials.