PURPOSE:Patients with pedal artery occlusive disease have limited options when presenting with chronic limb-threatening ischemia (CLTI). Serration angioplasty (SA) has demonstrated less recoil and improved freedom from reintervention compared with plain old balloon angioplasty within the tibial vessels. We aimed to identify the technical feasibility and clinical outcomes of SA within the pedal (inframalleolar) vasculature in patients with CLTI. MATERIALS AND METHODS:Patient with SA of the pedal vasculature for CLTI from January 01, 2021 to March 31, 2023 were included in this multicenter retrospective study. Pedal vessels were defined as any inframalleolar vessel distal to the talocrural joint. Patient demographics, anatomic and technical details, acute procedural outcomes, and outcomes at the most recent follow-up were collected for analysis. The primary endpoint was technical success, defined as SA with <50% residual target vessel stenosis. Secondary endpoints included freedom from vessel injury, amputation-free survival, clinically-driven target lesion revascularization (CD-TLR), composite major adverse limb events (MALEs), wound healing rate, and improvement in wound, ischemia, and foot infection (WIfI) clinical stage at the most recent follow-up. RESULTS:Of the identified 45 patients managed with pedal SA, median pre-intervention Rutherford classification was 5, and 91.9% of patients had concomitant below-the-knee tibial artery intervention. The most commonly treated artery was the dorsalis pedis (59.2%), with a median diameter SA of 2.5 mm. Residual stenosis was <50% in 93.3% of cases and <30% in 82.2%. Freedom from vessel injury was 93.3% (1 immediate occlusion and 2 bail-out stents). Six-month freedom from major amputation was 93.3%, freedom from pedal CD-TLR was 93.3%, and freedom from MALE was 80.0%. At a median follow-up of 163 days, 48.7% of patients had complete wound healing, with the total frequency of either healed or improving wounds of 79.5%. CONCLUSION:Serration angioplasty of the inframalleolar vasculature in patients with CLTI had high rates of technical success with a low incidence of vessel injury. At a median follow-up of 5.4 months, wound healing was ahead of previously published studies on inframalleolar intervention.Clinical ImpactThis represents the largest series of a specialty balloon used to treat pedal occlusive disease in chronic limb-threatening ischemia patients. As the rate of pedal intervention increases, using new technology to safely achieve luminal gain is crucial for both short- and long-term limb salvage.
To compare post-procedural changes in hemoglobin (HGB) following catheter-directed thrombolysis (CDL) vs. large-bore aspiration thrombectomy (LBAT) of acute pulmonary embolism (PE). Single-center retrospective review of acute high and intermediate-risk PE patients treated with CDL or LBAT between 12/2009 and 9/2023. The LBAT (FlowTriever, Inari Medical, Irvine, CA) group was divided according to usage of an autotransfusion device (ATD) (FlowSaver, Inari Medical). Patients were excluded if they received systemic tPA, had both LBAT and CDL in the same procedure, or had missing HGB data. There were 166 patients in the CDL group (56±15 years). The LBAT group included patients treated without an ATD (LBAT, n=58, 61±16 years) and with ATD (LBATw, n=47, 62±15 years). The age difference was significant (p=.01). The number of patients with intermediate risk PE was 91.6%, 89.6% and 87.3% in the CDL, LBAT and LBATw groups, respectively (p=.2). The remaining patients in each group had high risk PE. LBAT was performed using 16F, 20F and 24F catheters. The mean CDL duration was 25±7 hours, with a mean tPA dose of 27±5 mg. Endpoints included change in HGB between pre- and post-procedural measurements, as well as hemorrhagic adverse events (AE). The mean HGB changes in the CDL, LBAT, and LBATw groups were -1.3±1.3 g/dL, -1.6±0.98 g/dL, and -1.1±0.9 g/dL, respectively (p=.1). The estimated blood loss (EBL) during LBAT was 275.3±109.5 mL without ATD and 93.5±7 mL with ATD (p ≤ .001). The last HGB prior to initial procedure was not significantly different between groups (p=.5), with 13.2±2 g/dL, 13.3±2.4 g/dL, and 12.8±2.2 g/dL in the CDL, LBAT, and LBATw groups, respectively. The first HGB after the final procedure (< 24hrs) was not significant between groups (p=.7). GUSTO minor hemorrhagic AE rate was 3.6% in CDL, 12.1% in LBAT, and 14.9% in LBATw (p=.01). There were 1.2%, 3.4%, and 6.4% moderate hemorrhagic AE in the CDL, LBAT, and LBATw groups, respectively (p=.1). There were 1.2% major hemorrhagic AE in the CDL group and none in either LBAT group (p=.5). Blood transfusions were administered to 1.2%, 3.5% and 6.4% of patients in the CDL, LBAT and LBATw groups, respectively (p=.8). There were no procedure-related deaths in any group. There was no significant difference in post-procedural HGB change between CDL and LBAT regardless of usage of an ATD. There was significantly lower EBL in the LBAT group using ATD. There were more minor hemorrhagic AE in the LBAT groups. Moderate and severe AE rates were not different between the groups.
Effective management of type II endoleaks requires technical proficiency in multiple catheterization techniques depending on the supply and complexity of the endoleak. While the most commonly used access routes remain the transarterial and translumbar approaches, novel approaches such as transcaval access are increasingly being used in cases where the traditional techniques are unsuccessful or inadequate. The perigraft approach is an alternative novel option for endoleak embolization, which involves catheterization of the aneurysm sac between the common iliac artery and endograft. Our study aims to determine safety and effectiveness of the perigraft technique for embolization of type II endoleaks. Single-center retrospective review from 2014 to 2020 of 24 consecutive patients (12.5% female, mean age of 80.1 ± 6.4 years) who underwent 28 type II endoleak embolization procedures via a perigraft approach. Endpoints included technical success of perigraft catheterization, technical success of endoleak embolization, reintervention, freedom from AAA growth at follow-up, and adverse events. Technical success of perigraft catheterization and endoleak embolization were 92.9% and 89.3%, respectively. A combined transarterial and perigraft approach was employed in 30.8% (n = 8/26). Ethylene vinyl alcohol copolymer (Onyx) and coils were used in 92.9% and 46.4% cases, respectively. Freedom from AAA growth occurred in 85% (n = 17/20). Reintervention occurred in 20.8% (n = 5), including 4 repeat perigraft catheterizations. There were 2 SIR minor adverse events including a groin hematoma and dyspnea in a COPD patient. One major adverse event not related to the procedure was recorded involving an admission for atrial fibrillation and urinary retention. During follow up, 1 patient had AAA rupture 20 months after the successful index procedure requiring proximal snorkel extension and endograft relining. The 30-day mortality rate was 0. No type Ib endoleaks developed as a result of perigraft catheterization. The perigraft approach is safe and effective catheterization technique for embolization of type II endoleaks and can replace the translumbar and transcaval approaches in many cases with the advantage of not requiring sac puncture. Like the transcaval approach, it can be performed in a supine patient from a transfemoral approach and can be combined with other approaches if required. The perigraft approach is a useful addition to the armamentarium of catheterization techniques of type II endoleaks.
To compare the effectiveness and safety percutaneous Cryoablation (Cryo) and of microwave ablation (MWA) for the treatment of renal masses. A retrospective review was performed of renal mass ablation procedures between 2008 and 2020, which found 245 Cryo procedures and 94 MWA procedures (Age: 67.4 ± 12.9 vs. 67.8 ± 11.3 years, P = .8, Female: 37.6% vs. 34%, P = .6, respectively). Among these, there were 76 cryo procedures and 45 MWA procedures that were performed for biopsy proven renal cell carcinoma (RCC) (Age: 69.4 ± 10.7 vs. 66.5 ± 11.3 years, P = .2, Female: 26.3% vs. 28.9%, P = .8, respectively). The mRENAL and MC2 scores were similar between both groups, including between the proven RCC subgroups. Technical success was defined as the ablation zone encompassing mass and >5-mm margin, and along with adverse events, was reported for the entire cohort. Primary technical success (defined as no residual enhancement on first follow-up imaging) and time local progression were calculated for the RCC cohort. The technical success rate was similar (94.3% vs. 97.9%, P = .3) when comparing the entire cohort for Cryo and MWA, respectively, and in the RCC subgroups (93.4% vs. 97.8%, P = .4). Mean follow-up duration was 28.4 ± 24.6 months for Cryo and 33.5 ± 19.2 months for MWA (P = .2). Primary technical success was significantly higher (P = .049) with MWA (97.7%) than for Cryo (85.5%). The time to local progression was 74.8 months for a single patient in the Cryo RCC group. Reintervention rate for residual tumor or recurrence was higher in the Cryo RCC group than the MWA RCC group (12.5% vs. 2.3%, P = .09). The Cryo group had significantly more hemorrhagic complications (within 30 days of procedure) than the MWA group (25/239 (10.5%) vs. 3/94 (3.2%), P = .03). Injury to the collecting system occurred more commonly in the MWA group (6.4% vs. 2.1%, P = .08). Procedure related readmission rate was similar in the Cryo and MWA groups (4.1% vs. 4.3% respectively, P = .7). Percutaneous microwave ablation appears to have higher primary technical success, possibly resulting in less reinterventions for residual or recurrent RCC lesions. MW ablation resulted in more collecting system injuries but less hemorrhagic complications.
To evaluate the effect of adjunctive endovascular therapy on oxygen requirements at time of discharge for patients with acute pulmonary embolism (PE) Retrospective review of consecutive patients who presented with acute massive or submassive PE between January 2017 and August 2018 was performed. Oxygen requirements at discharge were compared with oxygen requirements at admission. Patients who did not survive the index admission were excluded. The control group included patients who were treated with anticoagulation (AC), while the study group included patients who underwent adjunctive EVT, including catheter-directed thrombolysis and/or aspiration thrombectomy. The primary endpoint was discharge with new or increased oxygen demand when compared with their preadmission status. A total of 195 patients were included in the cohort of which 147 (75.4%) were in the AC group and 48 (24.6%) in the CDT group. Aside from a higher rate of malignancies in the AC group (19% vs 6.3%, P = .04), demographics were similar between the groups. Initial PESI score and rate of administration of systemic tPA were slightly higher in the AC group (92.7 ± 36.1 vs 87.9 ± 31, P = .6 and 8.2% vs 2.1%, P = .19, respectively), but these did not reach statistical significance. A total of 31 patients (15.9%) were discharged with new or increased oxygen requirements, including 19.7% (29 of 147) in the AC group and 4.2% (2 of 48) in the EVT group, which was a statistically significant difference (P = .01). Adjunctive endovascular therapy appears to significantly decrease oxygen requirements at time of discharge when compared to anticoagulation alone in patients presenting with acute pulmonary embolism.
Comparing the outcome measures and safety of endovascular therapy (EVT) with anticoagulation (AC) in the treatment of acute pulmonary embolism (PE) utilizing a Pulmonary Embolism Response Team (PERT). Retrospective review of medical records between January 2017 and August 2018 was performed to identify patients with acute massive or submassive PE who were evaluated by the PERT. Included were patients who received AC with or without EVT. Excluded were patients who were treated with IVC filter only. Analysis was performed comparing patients who received AC alone and those who received AC and EVT. A subgroup analysis was performed for patients who were initially admitted to the ICU comparing AC with or without EVT. A total of 207 patients were identified, 4 were excluded as they did not receive AC and were treated only with IVC filters. There were 153 patients in the AC group and 50 in the EVT group. The AC group was significantly older (64.7 ± 16.4 vs. 58.2 ± 16.2 years, P = 0.02) and had a shorter ICU stay (0.97 ± 2.6 vs. 1.4 ± 1.5 days, P <0.001), although only 35.9% (n = 55) of the AC group were admitted to the ICU (compared to 70% (n = 35) in the EVT group, P <0.001). The rate for initial admission to a stepdown unit was 45.8% for the AC group and 16% for the EVT group (P <0.001). There was a 7.2% major hemorrhagic complication rate in the AC group and 6% in the EVT group (P = 1). The minor hemorrhagic complication rate was 1.3% for the AC group and 0% for the EVT (P = 1). When comparing patients who were initially admitted to the ICU, age (61.7 ± 16.7 vs. 57.7 ± 16.9 years, P = 0.2) and ICU stay (2 ± 2.2 vs. 1.9 ± 1.5 days, P = 0.15) were not significantly different between the AC and EVT groups, respectively. The total hospital stay for the AC group in the subgroup analysis was 7.7 ± 10.2 days while the EVT group stay was 6.3 ± 7.4 (P = 0.2). For patients evaluated by the PERT, major hemorrhagic complication rates were not significantly different between AC and EVT, and for patients initially admitted to the ICU, the ICU length of stay was not significantly different.
To evaluate the point in time, during catheter-directed thrombolysis (CDT) for acute pulmonary embolism (PE), when thrombolytic therapy has maximized its yield in the improvement of tachycardia. A retrospective chart review was performed for patients who underwent CDT with tPA for acute PE between December 2009 and August 2019. Included were patients with acute massive and submassive PE who presented with tachycardia (heart rate [HR] ≥100) at the time of initiation of CDT. Patients with chronic PE, atrial fibrillation, concomitant beta blocker therapy, or who expired before conclusion of CDT were excluded. HR was measured every hour or less during CDT. Graphs were plotted of HR as a function of CDT duration. Two interventional radiologists (IR) independently identified the inflection point on the graph where CDT had maximized its benefit in decreasing the patient’s HR. Discrepancies were adjudicated by a 3rd IR and the median of the 3 measurements was selected. The primary endpoint was the duration of CDT from initiation until the inflection point. Chart review identified 175 consecutive cases of CDT of which 109 were excluded, yielding a final cohort of 66 cases (age: 52.6 ± 14.8 years, 53% males). Initial HR was 110.2 ± 9.8 b/min and final HR was 86.8 ± 10.2 b/min (P <0.001) after 29.1 ± 13.7 hours of CDT at a mean infusion rate of 0.6 ± 0.2 mg/hr per catheter for a total dose 30.1 ± 14.4 mg. The primary endpoint was achieved after 13.8 ± 8.2 hours at a mean HR of 86.5 ± 9.4. There was no significant difference between the HR at the inflection point and the final HR (P = 0.64). A subgroup analysis was performed to compare patients whose tachycardia had resolved at the end of CDT (n = 59) with those for whom tachycardia did not resolve (n = 7). Although the HR at the inflection point in the latter group remained ≥100 (100.3 ± 7.1 b/min vs. 84.9 ± 8.2 b/min, P <0.001), the time to the inflection point was similar (P = 0.435). Maximum improvement of acute PE related tachycardia was achieved after approximately 14 hours of infusion without further improvement in HR despite continued CDT. This temporal relationship was sustained in the subgroup of patients whose tachycardia did not resolve.
The axillary artery is a useful alternative to other antegrade access options, such as brachial or radial, as it is closer to the peripheral vasculature, tends to be relatively spared of severe atherosclerotic disease, and can accommodate larger sheath sizes. This study looks to evaluate the feasibility and safety of percutaneous axillary artery access for endovascular interventions in patients with peripheral arterial disease (PAD). A retrospective electronic record review was performed of all patients who underwent percutaneous axillary access for endovascular PAD interventions from April 2018 to August 2019. Patient demographics and medical comorbidities were collected. Each procedure was reviewed for access indication, technical success, complications, as well as sheath size and closure devices used. Twenty percutaneous axillary access procedures were performed on 18 patients with a mean age of 68 (44.4% male). All axillary artery punctures were performed under ultrasound guidance. Procedural indications included chronic limb ischemia (n = 8), acute limb ischemia (n = 6), visceral intervention (n = 1) and aortic intervention with snorkel (n = 3). Reasons for axillary access included need for antegrade approach in 15 cases, hostile groin in 2, and occluded or heavily calcified common femoral arteries in 3. Sheath sizes ranged from 5 to 8 French. Hemostasis was achieved with closure devices in all patients including Angio-Seal (Terumo, Tokyo, Japan) in 19 accesses and Mynx Grip (Cardinal Health, Dublin OH) in 1. There were no perioperative access-related complications including stroke, arterial occlusion or hematoma. Axillary artery access is a viable access strategy in complex endovascular interventions requiring an antegrade approach with larger sheath sizes. This technique appears to be a feasible, effective, and safe based on this limited cohort.
To evaluate the need for routine prophylactic postprocedural antibiotics (ABX) following uterine fibroid embolization (UFE) in the prevention of procedure-related endometritis. Patients undergoing UFE at a single center between January 2013 and September 2019 were enrolled in a retrospective cohort study and divided into two groups. The control group consisted of patients treated before January 2016, who were prescribed postprocedural oral Ciprofloxacin 500 mg BID for 7 days. The study group consisted of patients treated after January 2016, who were not routinely prescribed postprocedural ABX. Patient demographics, procedural details and 90-day follow-up data were collected. The primary endpoint was the rate of endometritis within 90 days post procedure. A total of 434 patients were identified, consisting of 241 in the control group and 193 in the study group. Patient demographics and procedural details were similar in both groups including the diameter of the dominant fibroid, total number of fibroids and total number of vials of embolic material administered (P = 0.12, P = 0.052, P = 0.13, respectively). 29/192 (15.1%) patients in the study group underwent UFE with Embozene particles (Boston Scientific, Marlborough, MA). All other patients underwent UFE utilizing Embosphere particles (Merit Medical Systems, South Jordan, UT). Four (1.7%) and 2 (1%) patients developed endometritis in the control and experimental groups, respectively. Of the cases of suspected endometritis, two patients went on to undergo emergent total abdominal hysterectomy, both of whom were in the control group. One patient in the study group underwent myomectomy of a prolapsing fibroid. All other cases of endometritis were treated with antibiotics alone. The difference in infection rates between the groups was not statistically significant (P = 0.69). Foregoing routine postprocedural ABX did not result in a significantly increased rate of procedure-related endometritis in this cohort. However, the cohort is under-powered to demonstrate non-inferiority of the study group, as the reported post-UFE infection rate is exceedingly low.
Report outcomes of below-the-ankle (BTA) revascularization in critical limb ischemia (CLI) and investigate the association of pedal arch patency with limb salvage. A single-center review was conducted of CLI patients undergoing BTA revascularization (2009-2018). Records were reviewed for demographics, comorbidities, technical details and wound healing. Postintervention arteriograms were classified as demonstrating a complete (CPA), incomplete (IPA) or absent (APA) pedal arch. Clinical endpoints included overall survival (OS), minor (ankle preserving) amputation-free survival (AFS) and major (above-the-ankle) AFS at 6- and 12-months following initial BTA intervention. Sixty consecutive Rutherford Class 5 and 6 patients underwent BTA revascularization with concurrent tibial (100%) and femoropopliteal (55%) endovascular therapy. The mean age was 69 years with 58% male, 82% diabetic, 56% CKD and 48% smoker. Angioplasty of 81 BTA lesions (53 dorsalis pedis, 16 pedal arch, 12 lateral plantar) was performed including adjunctive orbital atherectomy in 3 cases. The pedal loop technique was used in 6 cases and retrograde pedal access technique in 18 cases. The 6- and 12-month OS was 95% and 95% with 3 mortalities attributed to cardiac arrest on postop day 32, 44 and 59. The 6- and 12-month minor AFS rate was 63% and 63%, respectively, with average amputation at 0.9 months. The 6- and 12-month major AFS rate was 65% and 58%, respectively, with average amputation at 2.5 months. Mean follow-up was 18.3 months with 43% achieving complete wound healing on average at 7.4 months and 42% censored due to major amputation or death. Postintervention, there were 25 (42%) complete pedal arches (CPA) and 35 (58%) incomplete pedal arches. Subgroup analyses showed no significant difference (P > 0.05) between pedal arch status and demographics, comorbidities, OS, major AFS or wound healing rates. However, the association between CPA and minor AFS was significant (P < 0.001). This study establishes a CPA as predictive of avoiding minor amputation in patients with CLI. Further study to stratify angiographic endpoints and patient selection for BTA intervention is needed.
To evaluate our experience with stenting of iliac vein compression lesions related to vascular etiologies and proposed subclassification. A retrospective review of 169 consecutive patients (196 limbs) with iliac vein obstruction treated with self-expanding nitinol stents between July 2011 and June 2017 was performed. Intra-procedural venography, intra-procedural intravascular ultrasound, pre-procedure CT/MRI, and post-procedure CT/MRI examinations were evaluated to identify patients with iliac vein compression from overlying iliac arteries. Patients with non-vascular compression or intrinsic iliac vein stricture were excluded. Patients with vascular iliac vein compression were subcategorized as follows: Type 1 – May-Thurner compression of left common iliac vein by right common iliac artery, Type 2 – Compression of left common or external iliac vein by left common or external iliac artery, Type 3 – Compression of right common or external iliac vein by right common or external iliac artery. Of the 169 patients, stented lesions were associated with identifiable etiologies of extrinsic compression in 109 (64.5%) patients. Nineteen patients were found to have nonvascular compression. Ninety were identified as having been treated for iliac artery-mediated iliac vein compression, including 55 (61.1%) with isolated Type 1 compression, 8 (8.9%) with isolated Type 2 compression, and 10 (11.1%) with isolated Type 3 compression. There were 12 (13.3%) patients with combined Type 1 and 2, 4 (4.4%) patients with Type 1 and 3, and 1 (1.1%) patient with Type 1, 2, and 3 compression. In this cohort of patients with arterial compression of iliac veins, only 61% demonstrated classic May-Thurner syndrome with compression of the left common iliac vein by the right common iliac artery. The presence of types 2 and 3 compression was associated with an increased chance of stent extension into the external iliac artery. The presence of type 3 compression in combination with types 1 and/or 2 is associated with an increased total number of stents.
To evaluate the effectiveness and safety profile of catheter-directed thrombolysis (CDT) for acute massive and submassive pulmonary embolism (PE). A retrospective review of 132 consecutive cases (age: 57 ± 15 years, 72 males) of CDT for acute massive (n = 23) and submassive (n = 109) PE between 2009 and 2017 was performed. All patients received full dose anticoagulation before and during thrombolysis with either enoxaparin (n = 37) or heparin (n = 95). Thrombolytic therapy was delivered via multi-sidehole infusion catheters, with or without ultrasound acceleration, or a combination of the two. Primary endpoints included change in invasive pulmonary artery pressure (PAP), change in angiographic thrombus burden (Miller score), hemorrhagic complications (according to GUSTO) and 30-day readmission rate. Secondary endpoints included demographics, duration of thrombolytic therapy, tissue plasminogen activator (tPA) dose infused, duration of intensive care unit (ICU) stay and hospital length of stay after the procedure. Mean PAP improved from 28.9 ± 8 mm Hg to 17.4 ± 11.1 (p<.001) while the Miller score improved from 19.2 ± 5.1 to 7.4 ± 3.9 (p<.001). There were 6 mild (4.5%), 5 moderate (3.8%) and 1 severe (0.8%) hemorrhagic complications, none of which were intracranial. The mortality rate during admission was 9.1% for the entire cohort, with 4.6% (n = 5) in the submassive group and 30.4% (n = 7) in the massive group (p<.001). The 30-day readmission rate was 5.2% for the surviving patients. The average infusion duration was 26.5 ± 13.1 hours over 2.3 ± 0.7 follow-up visits to the angiography lab, during which a mean of 27.9 ± 16.4 mg of tPA was infused. After the initiation of CDT, the mean ICU stay was 2.75 ± 4.6 days, while the mean hospital length of stay was 6.6 ± 8.3 days. Catheter-directed thrombolysis for acute PE is effective at reducing PAP and thrombus burden, and is associated with short ICU and hospital length of stay. Full dose anti-coagulation during CDT did not increase the hemorrhagic complication rates.
To evaluate the clinical and technical outcomes of nitinol self-expanding stents for the treatment of symptomatic chronic iliofemoral veno-occlusive disease. A retrospective review was performed of 169 consecutive patients (196 limbs) treated with self-expanding nitinol stents for chronic iliofemoral veno-occlusive disease between July 2011 and June 2017. Patients treated with non-nitinol stents and patients with IVC involvement were excluded. Procedural and follow-up data were collected for assessment of technical success, clinical outcomes, safety, and patency. Technical success was defined as the ability to recanalize and stent the obstructive lesion without significant residual stenosis. Binary patency was assessed with duplex ultrasound and calculated by Kaplan Meier analysis. Clinical outcomes were evaluated utilizing CEAP and Villalta scores. A total of 378 (278 Left, 95 Right) nitinol self-expanding stents were placed with sizes ranging from 8 to 14 mm. Technical success was achieved in 195 of 196 limbs (99%). Of the 169 patients, 100, 45, and 24 presented with symptoms consistent with acute, acute on chronic, and chronic DVT, respectively. Mechanical thrombectomy was performed in 96 (49%) patients while catheter-directed thrombolysis was employed in 92 (47%) patients. Mean followup time was 9.8 months. Kaplan Meier analysis revealed a primary patency of 95%, 93%, 91%, and 91% at 6, 12, 24, and 36 months respectively. Pre- and post-CEAP or Villalta scores were available in 140 (83%) patients. CEAP and Villalta scores improved from 3.65 to 2 (-55%) and 19.15 to 8.6 (-45%), respectively. There were 5 recorded adverse events; 3 mild, 1 moderate, and 1 severe. Endovascular management of chronic iliofemoral veno-occlusive disease with self-expanding nitinol stents is a safe and durable procedure with high technical success, excellent mid-term patency, and good clinical outcomes.
To evaluate the outcome of iliocaval stent-assisted reconstruction in patients with chronic iliocaval obstruction with and without superimposed acute thrombosis. A retrospective review was performed of consecutive patients undergoing iliocaval stenting for chronic obstructive lesions from 1/2009 to 7/2017. Patients with chronic obstructions of the iliofemoral veins without IVC involvement (including May-Thurner) were excluded. Adjunctive treatments included venoplasty, pharmacomechanical thrombectomy (PMT), and catheter-directed thrombolysis (CDT). Endpoints included technical success, clinical success, adverse events, and patency. Technical success was defined as successful recanalization and stenting. Clinical success was defined as resolution of symptoms or decrease in Villalta score of at least 5. Twenty-nine consecutive patients (18 male, mean age 47) were enrolled in the study. Technical success was 100%. Mean number of stents used per interventional session was 7.3. The majority of stents used in the IVC were Wallstents (Boston Scientific) while self-expanding nitinol stents were used exclusively in the iliac veins. Adjunctive PMT and CDT were performed in 14 and 20 patients, respectively. Eight patients underwent repeat procedures (range, 2-10) during the follow-up period for recurrence or extension of disease. The IVC obstruction was caused by an indwelling filter in 9 patients. Of those 9, 5 filters were removed prior to IVC stenting, 3 were recanalized by balloon venoplasty, and 1 was excluded by stenting. No major adverse events were recorded. Five patients were lost to follow-up with a mean follow-up of 26.1 months in the remaining patients. Clinical success was 95.8%. Primary and secondary patency was 68% and 95% at 12 months, 53% and 95% at 24 months, and 35% and 95% at 36 months, respectively. Endovascular IVC and iliac vein stenting is a safe and effective method for the treatment of patients with chronic iliocaval veno-occlusive disease.
To evaluate the effect on serum fibrinogen levels of catheter-directed thrombolysis (CDT) for treatment of acute massive or submassive pulmonary embolism (PE). A retrospective review in a single health care system between 2009 and 2017 was performed to identify patients who underwent CDT utilizing tPA for acute massive or submassive PE with and without ultrasound-accelerated thrombolysis (USAT). Full dose anticoagulation was administered before and during CDT with either heparin or enoxaparin. Endpoints included serum fibrinogen levels obtained approximately every 6 hours during treatment, infusion duration, tPA dose and hemorrhagic complications (GUSTO). 121 cases of CDT for acute PE were reviewed (Age: 57.5 ± 14.1, 69 males, 17 massive PE) including 39 cases in which USAT was utilized exclusively, and 35 patients who received enoxaparin. The mean initial fibrinogen level was 372.2 ± 123.3 mg/dl (range, 65-884), while the mean final fibrinogen level was 351.8 ± 124.9 mg/dl (56-788), with a statistically significant (p = .01) mean reduction of 20.4 ± 78.8 mg/dl (5.5%). Mean infusion duration was 27.4 ± 12.9 hours (6-67), and the mean tPA dose infused was 29.2 ± 16.1 mg (4.8-114). When comparing USAT to conventional CDT, and enoxaparin to heparin, there was no significant difference in initial fibrinogen level (p = .34 and p = .9 respectively) or fibrinogen reduction (p = .94 and p = 42 respectively) between the groups. There were 9 hemorrhagic complications (6 GUSTO mild, 2 moderate and 1 severe) in 9 patients with a mean age of 63.9 ± 15.5 years. Initial and final fibrinogen levels in those 9 patients were 335.7 ± 218.9 mg/dl and 10.3 ± 71.5 mg/dl (3.1%), respectively, with a non-significant (p = .77) mean reduction of 10.3 ± 71.5 mg/dl (3.1%). In this cohort, CDT for acute PE significantly reduced serum fibrinogen but the reduction did not correlate clinically with hemorrhagic complications. The use of USAT versus conventional CDT or the choice of heparin versus enoxaparin did not have an effect on fibrinogen levels.
To compare technical aspects and clinical outcome of ultrasound-accelerated thrombolysis (USAT) with pigtail catheter directed thrombolysis (PCDT) for the treatment of acute pulmonary embolism (PE). A retrospective study was performed of consecutive patients treated with catheter-directed thrombolysis (CDT) for acute massive and submassive PE between 2010 and 2016. Patients were divided into 2 groups according to the method of CDT used. In the USAT group, recombinant tissue plasminogen activator (TPA, Genentech Inc, San Francisco, CA) was administered using the EKOS system (EKOS Corp, Bothell, WA), while in the PCDT group, TPA was delivered via angled pigtail catheters (Cook Medical, Bloomington, IN). Patient demographics, right ventricular strain index, adverse events, change in pulmonary artery pressure (PAP) and Miller PE severity score were compared between the groups. Fifty two patients were enrolled in the study including 21 (19 submassive and 2 massive) in the USAT group and 33 (28 submassive and 5 massive) in the PCDT group. Demographics, PE burden and RV/LV ratios were not significantly different between the groups (p>.05). Procedure and fluoroscopy time were significantly longer in the USAT group (p<.001). The USAT group received a significantly lower total dose of TPA (26.5 ± 10.6 vs 34.9 ± 13.7 mg, p = .026), and showed a trend towards shorter infusion times (25.1 ± 8.4 vs 31.4 ± 12.6 hours, p = .08). There was no significant difference in the change in PAP between the groups. Reduction in Miller score was significantly greater in the PCDT group (11.6 vs 14.6 p = .007). However, when comparing procedural and clinical endpoints through the first follow-up angiogram only (mean of 21.5 hours), no significant difference was recorded between the groups. A single 30-day mortality was recorded in each group. A single case of major hemorrhage was noted in the PCDT group. USAT and PCDT demonstrate comparable effectiveness for CDT in patients with acute PE. Although the TPA dose and infusion times were shorter in the USAT group, this did not translate into any differences in clinical endpoints through the initial 22 hours of infusion.
To evaluate the necessity of prophylactic post-procedural administration of antibiotics (ABX) after uterine fibroid embolization (UFE) in the prevention of procedure-related infections. Patients undergoing UFE at a single center between June 2015 and August 2016 were enrolled in a prospective cohort study and divided into 2 groups. The control group consisted of patients treated before January 2016, who were prescribed post-procedural oral Ciprofloxacin 500mg BID for 7 days. The study group consisted of patients treated after January 2016, who were not prescribed post-procedural ABX. A single dose of pre-procedural ABX was administered to all patients per SIR guidelines. Patient demographics, procedure details and 30-day follow-up data were collected. The primary endpoint of the study was infection rate within 30 days of the procedure. A total of 85 patients were enrolled in the study, consisting of 48 in the control group and 37 in the study group. Patient demographics and procedure details were similar in both groups. Apart from 6 patients in the study group who underwent UFE with Embozene particles (Boston Scientific, Marlborough, MA), all patients underwent UFE utilizing Embosphere particles (Merit Medical Systems, South Jordan, UT). A single patient in the study group presented with malodorous discharge 15 days postop and was treated with oral ABX. No infectious complications were recorded in the control group. The difference in infection rate between the groups was not statistically significant (p = 0.435). Withholding prophylactic post-procedural ABX did not result in a significantly increased rate of procedure-related infections. However, the study is under-powered to demonstrate non-inferiority of the study group, as the reported post-UFE infection rate is exceedingly low. Nonetheless, this pilot study does serve as a model for a larger scale study.
To evaluate our experience and outcome of type II endoleak embolization using EVOH in patients with AAA sac expansion post EVAR. A retrospective review was performed of consecutive patients undergoing embolization of type II endoleaks with EVOH from 1/2009 to 6/2016. The goal of treatment was to embolize the endoleak nidus along with communicating branches. The approach to endoleak catheterization was dependent on its location and source. Retrograde catheterization of communicating branches was performed for the inferior mesenteric artery as well as accessible lumbar arteries. In the event of failed or inaccessible retrograde transarterial catheterization, or if additional access to the endoleak was required, a direct approach was employed to catheterize the endoleak, including translumbar, transabdominal and perigraft approaches. The latter approach involves undermining the endograft at an iliac limb apposition site. Patients were followed by CT to assess for persistent/recurrent endoleaks and progression of AAA cross-sectional area. Thirty-six consecutive patients (26 male, mean age 81) were enrolled in the study. Mean time from EVAR to the index embolization procedure was 45.6 months. The transarterial, direct, and perigraft approaches were used in 15, 14, and 13 cases, respectively. Adjunctive coil embolization was performed in 21 cases. No major adverse events were recorded. Twenty-two of 37 (59.5%) cases showed resolution of the endoleak at initial post-procedural CT (mean 2 months). Four patients subsequently developed recurrent type II endoleaks (mean 7 months from index procedure), while 1 patient developed a type I endoleak (11 months). At final follow-up CT (mean 11.3 months), 52% of patients showed stability ( ± 5 cm2) or decrease (≥ 5 cm2) in the maximal cross-sectional AAA area. EVOH embolization is a safe and effective method for the prevention of aneurysm sac expansion in patients with type II endoleaks post EVAR. We found a trend over time, of abandoning the cumbersome transarterial retrograde lumbar artery catheterization and direct translumbar approaches in favor of the more efficient perigraft and direct transabdominal approaches.
To evaluate the correlation of pulmonary artery pressure (PAP) measurements with thrombus burden on serial pulmonary angiograms performed as part of catheter-directed thrombolysis (CDT) for acute pulmonary embolism (PE). A retrospective review of charts, between the years 2010 and 2016, was performed to identify patients who underwent CDT for acute massive or submassive PE, and who endured more than a single follow-up angiogram as part of their CDT treatment. Recombinant tissue plasminogen activator (TPA, Genentech Inc, San Francisco, CA) was used in all procedures. Data regarding patient demographics, infusion time, TPA dose, change in PAP and change in Miller PE severity score (a reflection of thrombus burden) was collected. Thirty-four patients were identified, including 3 who underwent 3 follow-up angiograms with PAP measurement and 31 who underwent 2 follow-up angiograms with PAP measurement during the course of CDT for acute PE. Mean time interval between angiograms was 18.8 hours. The mean TPA dose through the first, second and third follow-up was 20.5 mg, 37.9 mg, and 41.7 mg, respectively. Initial mean PAP was 31.5 ± 6.6 mmHg, which was reduced to 24.6 ± 7.6 mmHg (p<.001) at first follow-up (18.8 hrs), and to 21.4 ± 8.1 mmHg (p = .001) at the second follow-up (37.9 hrs) angiogram, yet remained stable at 21.7 ± 19.3 mmHg (p = .6) at third follow-up (56.3 hrs). Review of pulmonary angiograms yielded Miller PE severity scores of 19.5 ± 6.8, 12 ± 6.6 (p<.001), 6.6 ± 4.3 (p<.001) and 5.5 ± 5.3 (p = .066) at baseline, first, second and third follow-up, respectively. No adverse events were encountered during the course of CDT. Increased infusion time and TPA dose were effective in reducing thrombus burden and mean PAP. However, the greatest change was realized within the first day of infusion with diminishing reductions thereafter and no significant change after day 2. There was excellent correlation between PAP and Miller score at all time points, suggesting that patients undergoing CDT for PE can be followed by PAP measurements alone without the need for serial pulmonary angiograms.