Randomized,Double-Blind,Placebo-Controlled Trial to Evaluate Safety and Therapeutic Efficacy of Angiogenesis Induced by Intraarterial Autologous Bone Marrow–Derived Stem Cells in Patients with Severe Peripheral Arterial Disease

PurposeTo evaluate safety and efficacy of angiogenesis induced by intraarterial autologous bone marrow–derived stem cell (BMSC) injection in patients with severe peripheral arterial disease (PAD).Materials and MethodsEighty-one patients with severe PAD (77 men), including 56 with critical limb ischemia (CLI) and 25 with severe claudication, were randomized to receive sham injection (group A) or intraarterial BMSC injection at the site of occlusion (group B). Primary endpoints included improvement in ankle–brachial index (ABI) of > 0.1 and transcutaneous pressure of oxygen (TcPO₂) of > 15% at mid- and lower foot at 6 mo. Secondary endpoints included relief from rest pain, > 30% reduction in ulcer size, and reduction in major amputation in patients with CLI and > 50% improvement in pain-free walking distance in patients with severe claudication.ResultsTechnical success was achieved in all patients, without complications. At 6 mo, group B showed more improvements in ABI of > 0.1 (35 of 41 [85.37%] vs 13 of 40 [32.50%]; P < .0001) and TcPO₂ of > 15% at the midfoot (35 of 41 [85.37%] vs 17 of 40 [42.50%]; P = .0001] and lower foot (37 of 41 [90.24%] vs 19 of 40 [47.50%]; P < .0001). No patients with CLI underwent major amputation in group B, compared with 4 in group A (P = .0390). No significant difference was observed in relief from rest pain or > 30% reduction in ulcer size among patients with CLI or in > 50% improvement in pain-free walking distance among patients with severe claudication.ConclusionsIntraarterial delivery of autologous BMSCs is safe and effective in the management of severe PAD.     

Three-Year Efficacy and Safety of the Misago Peripheral Stent for Superficial Femoral Artery Disease: Final Results from the OSPREY Trial

PurposeThis study evaluated the long-term outcomes of the Misago peripheral stent trial (Terumo) for atherosclerotic lesions in the superficial femoral artery (SFA) in patients with claudication.Materials and MethodsThis was a prospective multicenter, single-arm, clinical trial of primary stent placement for de novo cases of SFA disease conducted in the United States and Asia. The primary endpoint was freedom from clinically driven target lesion revascularization (CD-TLR) at 36 months. Secondary outcomes were ankle-brachial index (ABI), Rutherford score, Walking Impairment Questionnaire (WIQ), a quality of life survey, and rate of device fracture.ResultsA total of 276 patients (64.4% male; mean age, 69.3 ± 10.1 years) were enrolled. Freedom from CD-TLR was 78.5% (95% confidence interval [CI], 73.0%–83.0%) at 24 months and 75.4% (95% CI, 69.6%–80.2%) at 36 months. Baseline ABI was 0.7 ± 0.1 and 0.98 ± 0.20 (P < .001) at 30 days after the procedure. Baseline Rutherford score was 3.6 ± 0.6 and 1.6 ± 1.0 30 at 30 days after the procedure (P < .001). Mean (and changed) ABI and Rutherford score at 36 months compared to day 30 after the procedure were, respectively, 0.91 (−0.1 ± 0.2) and 1.5 (−0.2 ± 1.1). WIQ score at baseline was 21.49 ± 26.30 and 50.51 ± 38.49 at 30 days after the procedure ( P < .001). The mean WIQ score at 2 years was 46.65 ± 37.31 (P = .12). Stent fracture rate at 36 months was 2.0% (4 of 202 patients).ConclusionsOSPREY (Occlusive-Stenotic Peripheral Artery Revascularization Study) 36-month data demonstrated persistent freedom from CD-TLR and sustained improvement in ABI and Rutherford score with primary stent placement for SFA lesions.     

The Use of an Inflatable Adhesive External Compression Device for Maintenance of Hemostasis following Angiography in Children

PurposeTo assess the safety and efficacy of the posthemostasis use of an inflatable adhesive external compression device (SafeGuard) following angiography in children performed under general anesthesia.Materials and MethodsMedical records of 74 children (43 females) with a mean age of 8.9 years (range, 0.4–18.0 years) and mean weight of 44.0 kg (range, 7.3–115.7 kg) in whom an inflatable adhesive external compression device was used for maintaining hemostasis following angiography under general anesthesia were retrospectively reviewed. After establishing hemostasis with manual compression, the device was applied and inflated over the arteriotomy. The patients were assessed for access-related adverse events in the recovery unit and during postprocedural follow-up.ResultsThe inflatable adhesive external compression device was utilized to maintain hemostasis following 181 angiography procedures. The mean length of the procedure was 396 minutes. The common femoral artery (n = 170, 93.9%) was the most common access, using 4–5-F vascular sheath (n = 118, 65.2%) or 3–5-F sheathless (n = 8, 12.7%) catheters. The mean time to deflation was 93 minutes. There were no adverse events other than minor bleeding from the arteriotomy after deflation (n = 2, 1.1%) and early deflation of the device because of pain (n = 1, <1%). Follow-up ultrasonography (n = 109 procedures, 60.2% at a mean follow-up of 2.2 years) demonstrated patency of the access artery.ConclusionsThe use of an inflatable adhesive external compression device following angiography in children to maintain hemostasis during the emergence phase of anesthesia and recovery period is safe and effective. The use of this simple device may reduce the need for postprocedural sedation and facilitate early discharge.     

Embolization versus Surgery for Stabilized Patients with Solid Organ Injury

PurposeTo compare embolization with laparotomy for the management of hemodynamically unstable patients with solid organ injury who responded to initial resuscitation.Materials and MethodsData from a Japanese nationwide trauma registry were analyzed. Included were hemodynamically unstable patients (systolic blood pressure <90 mm Hg and blood transfusion within the first 24 hours) whose initial computed tomography assessment confirmed the presence of solid organ injuries (liver and/or spleen). A total of 224 patients were included (median age: 53 years, interquartile range: 32–69; 73.3% male; liver injury = 131 [58%] and spleen injury = 98 [44%]; median organ injury scale: 3, interquartile range: 3–4; median injury severity score: 19, interquartile range: 16–25). Patients who underwent embolization were compared with those who underwent laparotomy. The primary outcome was in-hospital survival. The data were evaluated using a propensity score matching analysis.ResultsLaparotomy and embolization were performed in 133 (59.1%) and 91 (40.4%) patients, respectively. Of those, 111 (84%) and 84 (92%) patients achieved in-hospital survival after laparotomy and embolization, respectively. No significant difference in in-hospital survival (P = .053) was noted. The propensity score matching model did not reveal a significant difference in in-hospital survival (P = .276).ConclusionsNo significant difference was observed between embolization and laparotomy in terms of in-hospital survival among unstable patients who responded to initial resuscitation with solid organ injury.     

Predictors for Nonhome Patient Discharge following Lower Extremity Arterial Interventions

PurposeTo identify the variables associated with patient discharge disposition to optimize postprocedural care and discharge planning following lower extremity arterial interventions for peripheral artery disease (PAD).Materials and MethodsThe 2014–2017 American College of Surgeons National Surgical Quality Improvement Program database was queried using current procedural terminology codes for endovascular infrainguinal interventions for PAD. The main outcome variable of interest was nonhome discharge. Covariates included patient sociodemographic variables, age quartile (upper quartile, ≥77 years), comorbidities (diabetes, renal disease, bleeding disorder, congestive heart failure [CHF], and chronic obstructive pulmonary disease), presence of an open wound before a procedure, type of procedure, operative time, symptom severity, American Society of Anesthesiologists class, and baseline functional status. Univariate analysis and multivariate logistic regression were performed on Stata/SE 15.1.ResultsA total of 3,190 patients met the inclusion criteria, of whom 664 (20.8%) had nonhome discharge. Multivariate regression revealed that age (odds ratio [OR], 1.9 for the upper age quartile [>77 years]; 95% confidence interval [CI], 1.46–2.50), operative time (OR, 1.2 per increase in quartile; 95% CI, 1.09–1.30), preoperative wound (OR, 1.5; 95% CI, 1.24–1.90), renal failure (OR, 1.7; 95% CI, 1.30–2.14), CHF (OR, 2.2; 95% CI, 1.51–3.24), symptom severity (OR, 1.7; 95% CI, 1.46–1.98), and independent functional status (OR, 0.74; 95% CI, 0.59–0.92; P = .007) were associated with nonhome discharge. All P values were ≤.001 unless otherwise stated.ConclusionsProlonged procedural time, the presence of preprocedural wound and patient comorbidities, symptomatology, and baseline functional status may be used to identify patients who will require a nonhome discharge and early discharge planning.     

Superior Rectal Artery Embolization with Tris-Acryl Gelatin Microspheres: A Randomized Comparison of Particle Size

PurposeTo evaluate the safety and efficacy of superior rectal artery embolization (SRAE) with different-sized tris-acryl gelatin microspheres in symptomatic hemorrhoidal disease (HD).Materials and MethodsForty-two patients (male, 30; female, 12; median age, 45 years) with symptomatic HD (2 grade I, 8 grade II, 17 grade III, and 15 grade IV) were divided into 3 experimental arms (500–700 μm, 700–900 μm, and 900–1,200 μm groups; each had 14 patients) in a prospective randomized style to perform SRAE. Follow-up was performed by rectoscopy, clinical examination, and questionnaires. The primary outcome measure was the clinical success rate at 12 months. Secondary outcome measures were technical success rate, recurrence rate, procedure-related mortality, procedure-related complications, and any outcome changes between particle sizes.ResultsNo procedure-related deaths or major morbidities were observed. There was a 54% minor complication rate (n = 23/42) in the treated zone: 45% sustained small superficial ulcerations (n = 19/42), 7% small rectosigmoid junction ulcerations (n = 3/42), and 2% small fibrotic scar tissue (n = 1/42). The clinical success rate was 93%. Of the groups, the best French bleeding score decrease was obtained in the 900–1,200 μm group. There were improvements in the quality of life score and visual analogue scale score after the SRAE procedure, although not in the Goligher score. No recurrent disease was observed.ConclusionsSRAE with tris-acryl gelatin microspheres for symptomatic HD is a safe and efficient treatment, with results favoring the use of larger microspheres.     

Diagnostic Performance of CT-Guided Bone Biopsies in Patients with Suspected Osteomyelitis of the Appendicular and Axial Skeleton with a Focus on Clinical and Technical Factors Associated with Positive Microbiology Culture Results

PurposeTo assess diagnostic performance of CT-guided percutaneous needle bone biopsy (CTNBB) in patients with suspected osteomyelitis and analyze whether certain clinical or technical factors were associated with positive microbiology results.Materials and MethodsAll CTNBBs performed in a single center for suspected osteomyelitis of the appendicular and axial skeleton during 2003–2018 were retrospectively reviewed. Specific inclusion criteria were clinical and radiologic suspicion of osteomyelitis. Standard of reference was defined using outcome of surgical histopathology and microbiology culture and clinical and imaging follow-up. Technical and clinical data (needle size, comorbidities, clinical factors, laboratory values, blood cultures) were collected. Logistic regression was performed to assess associations between technical and clinical data and microbiology biopsy outcome.ResultsA total of 142 CTNBBs were included (46.5% female patients; age ± SD 46.10 y ± 22.8), 72 (50.7%) from the appendicular skeleton and 70 (49.3%) from the axial skeleton. CTNBB showed a sensitivity of 42.5% (95% confidence interval [CI], 32.0%–53.6%) in isolating the causative pathogen. A higher rate of positive microbiology results was found in patients with intravenous drug use (odds ratio [OR] = 5.15; 95% CI, 1.2–21.0; P = .022) and elevated white blood cell count ≥ 10 × 10⁹/L (OR = 3.9; 95% CI, 1.62–9.53; P = .002). Fever (≥ 38°C) was another clinical factor associated with positive microbiology results (OR = 3.6; 95% CI, 1.3–9.6; P = .011).ConclusionsCTNBB had a low sensitivity of 42.5% for isolating the causative pathogen. Rate of positive microbiology samples was significantly higher in patients with IV drug use, elevated white blood cell count, and fever.     

CT assessment of the left atrial appendage post-transcatheter occlusion – A systematic review and meta analysis

BackgroundTransesophageal echocardiography (TEE) is the standard imaging modality used to assess the left atrial appendage (LAA) after transcatheter device occlusion. Cardiac computed tomography angiography (CCTA) offers an alternative non-invasive modality in these patients. We aimed to conduct a comparison of the two modalities.MethodsWe performed a comprehensive systematic review of the current literature pertaining to CCTA to establish its usefulness during follow-up for patients undergoing LAA device closure. Studies that reported the prevalence of inadequate LAA closure on both CCTA and TEE were further evaluated in a meta-analysis. 19 studies were used in the systematic review, and six studies were used in the meta-analysis.ResultsThe use of CCTA was associated with a higher likelihood of detecting LAA patency than the use of TEE (OR, 2.79, 95% CI 1.34–5.80, p ?= ?0.006, I² ?= ?70.4%). There was no significant difference in the prevalence of peridevice gap ≥5 ?mm (OR, 3.04, 95% CI 0.70–13.17, p ?= ?0.13, I² ?= ?0%) between the two modalities. Studies that reported LAA assessment in early and delayed phase techniques detected a 25%–50% higher prevalence of LAA patency on the delayed imaging.ConclusionCCTA can be used as an alternative to TEE for LAA assessment post occlusion. Standardized CCTA acquisition and interpretation protocols should be developed for clinical practice.     

Effectiveness of Thermal Ablation and Stereotactic Radiotherapy Based on Stage I Lung Cancer Histology

PurposeTo assess whether the effectiveness of thermal ablation (TA) and stereotactic body radiotherapy (SBRT) as initial treatments for stage I lung cancer varies depending on the histological subtype.Materials and MethodsThe 2004–2016 National Cancer Database was queried for patients with American Joint Committee on Cancer stage I lung cancer treated with TA or SBRT. Patients <18 years, those treated with surgery or chemotherapy, or those with unknown survival and follow-up were excluded. TA and SBRT patients were 1:5 propensity score matched separately for each histological subtype to adjust for confounders. Overall survival (OS) was assessed using Cox models.ResultsA total of 28,425 patients were included (SBRT, n = 27,478; TA, n = 947). TA was more likely to be used in Caucasian patients, those with more comorbidities and smaller neuroendocrine tumors (NETs) of the lower lobe, and those whose treatment had taken place in the northeastern United States. After propensity score matching, a cohort with 4,085 SBRT and 817 TA patients with balanced confounders was obtained. In this cohort, OS for TA and SBRT was comparable (hazard ratio = 1.07; 95% confidence interval,0.98–1.18; P = .13), although it varied by histological subtypes: higher OS for TA was observed in patients with non–small cell NETs (vs SBRT hazard ratio = 0.48; 95% confidence interval, 0.24–0.95; P = .04). No significant OS differences between TA and SBRT were noted for adenocarcinomas, squamous cell carcinomas, small cell carcinomas, and non-neuroendocrine large cell carcinomas (each, P > .1).ConclusionsOS following TA and SBRT for stage I lung cancer is comparable for most histological subtypes, except that OS is longer after TA in non–small cell NETs.     

The Use of Vascular Closure Devices for Brachial Artery Access: A Systematic Review and Meta-Analysis

PurposeTo estimate the rates of technical success and adverse events of vascular closure devices (VCDs) in the brachial artery and compare the rates of adverse events with manual compression.Materials and MethodsMEDLINE and Embase were searched for observational studies examining VCDs in the brachial artery. Meta-analyses were performed using random effects for the following outcomes: (a) technical success, (b) hematoma at the access site, (c) pseudoaneurysm, (d) local neurological adverse events, and (e) total number of adverse events. A pairwise meta-analysis compared VCD with manual compression for the outcomes of hematoma and the total number of adverse events.ResultsOf 1,761 eligible records, 16 studies including 510 access sites were included. Primary procedures performed were peripheral arterial disease interventions, percutaneous coronary intervention, and endovascular thrombectomy for ischemic stroke. The technical success rate was 93% (95% CI, 87%–96%; I² = 47%). Data on the following adverse events were obtained via meta-analysis: (a) hematoma, 9% (5%–15%; I² = 54%); (b) stenosis or occlusion at access site, 3% (1%–14%; I² = 51%); (c) infection, 0% (0%–5%; I² = 0%); (d) pseudoaneurysm, 4% (1%–13%; I² = 61%); (e) local neurological adverse events, 5% (2%–13%; I² = 54%); and (f) total number of adverse events, 15% (10%–22%; I² = 51%). Angio-Seal success rate was 96% (93%–98%; I² = 0%), whereas the ExoSeal success rate was 93% (69%–99%; I² = 61%). When comparing VCD and manual compression, there was no difference in hematoma formation (relative risk, 0.75; 95% CI, 0.35–1.63; I² = 0%; P = .47) or the total number of adverse events (relative risk, 0.75; 95% CI, 0.35–1.58; I² = 76%; P = .45).ConclusionsDespite being off-label, studies suggest that VCDs in the brachial artery have a high technical success rate. There was no significant difference in adverse events between VCDs and manual compression in the brachial artery.     

Vascular Pathology and Impact of Stent Eccentricity for Stent Restenosis in Femoropopliteal Endovascular Therapy

PurposeTo explore the clinical features associated with stent eccentricity and reveal the impact of stent eccentricity on the risk of 1-year restenosis after femoropopliteal stent implantation for symptomatic atherosclerotic peripheral artery disease (PAD).Materials and MethodsThe clinical database of a multicenter prospective study was used. It registered 2,018 limbs of 1,766 patients in whom intravascular ultrasound (IVUS)-supported femoropopliteal endovascular therapy (EVT) for symptomatic atherosclerotic PAD was planned from November 2015 to June 2017. The study included 1,233 limbs of 1,088 patients implanted with a bare nitinol stent, drug-eluting stent (DES), or stent graft and administered ≥2 antithrombotic drugs. The stent eccentricity was evaluated using IVUS, calculated as [(maximum diameter) / (minimum diameter) ? 1] at the cross-sectional segment with the lowest lumen area after stent implantation.ResultsChronic total occlusion and bilateral arterial calcification (peripheral artery calcification scoring system Grades 3 and 4) were positively associated with stent eccentricity, whereas renal failure while receiving dialysis, DES use, and stent graft use were negatively associated with stent eccentricity (all P < .05). Stent eccentricity was associated with an increased risk of 1-year restenosis (odds ratio [OR], 1.18; 95% CI, 1.01–1.37; P = .034). However, after adjustment for lesion severity and implanted stent types, the association was no longer significant (OR, 1.07; 95% CI, 0.91–1.24; P = .43).ConclusionsStent eccentricity was not significantly associated with the risk of 1-year restenosis after femoropopliteal EVT.     

Stereotactic Body Radiotherapy for Stage I Renal Cell Carcinoma: National Treatment Trends and Outcomes Compared to Partial Nephrectomy and Thermal Ablation

PurposeTo assess use of stereotactic body radiotherapy (SBRT) for stage I renal cell carcinoma (RCC) and compare outcomes with thermal ablation and partial nephrectomy (PN).Materials and MethodsThe 2004–2015 National Cancer Database was investigated for histopathologically proven stage I RCC treated with PN, cryoablation, radiofrequency (RF) or microwave (MW) ablation, or SBRT. Patients were propensity score–matched to account for potential confounders, including patient age, sex, race, comorbidities, tumor size, histology, grade, tumor sequence, administration of systemic therapy, treatment in academic vs nonacademic centers, treatment location, and year of diagnosis. Overall survival (OS) was evaluated with Kaplan-Meier plots, log-rank tests, and Cox proportional hazards models.ResultsA total of 91,965 patients were identified (SBRT, n = 174; PN, n = 82,913; cryoablation, n = 5,446; RF/MW ablation, n = 3,432). Stage I patients who received SBRT tended to be older women with few comorbidities treated at nonacademic centers in New England states. After propensity score matching, a cohort of 636 patients was obtained with well-balanced confounders between treatment groups. In the matched cohort, OS after SBRT was inferior to OS after PN and thermal ablation (PN vs SBRT, hazard ratio [HR] = 0.29, 95% confidence interval [CI] 0.19–0.46, P < .001; cryoablation vs SBRT, HR = 0.40, 95% CI 0.26–0.60, P < .001; RF/MW ablation vs SBRT, HR = 0.46, 95% CI 0.31–0.67, P < .001). Compared with PN, neither cryoablation nor RF/MW ablation showed significant difference in OS (cryoablation vs PN, HR = 1.35, 95% CI 0.80–2.28, P = .258; RF/MW ablation vs PN, HR = 0.64, 95% CI 0.95–2.55, P = .079).ConclusionsCurrent SBRT protocols show lower OS compared with thermal ablation and PN, whereas thermal ablation and PN demonstrate comparable outcomes.     

Predictors of Clinical Outcomes of Pharmacomechanical Catheter-Directed Thrombolysis for Acute Iliofemoral Deep Vein Thrombosis: Analysis of a Multicenter Randomized Trial

PurposeTo identify the baseline patient characteristics that predict who will benefit from pharmacomechanical catheter-directed thrombolysis (PCDT) of acute iliofemoral deep vein thrombosis (DVT).Materials and MethodsIn the Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) multicenter randomized trial, 381 patients with acute iliofemoral DVT underwent PCDT and anticoagulation or anticoagulation alone. The correlations between baseline factors and venous clinical outcomes were evaluated over 24 months using post hoc regression analyses. Interaction terms were examined to evaluate for differential effects by treatment arm.ResultsPatients with clinically severe DVT (higher baseline Villalta score) experienced greater effects of PCDT in improving 24-month venous outcomes, including moderate or severe postthrombotic syndrome (PTS) (odds ratios [ORs] and 95% confidence intervals [CIs] per unit increase in the baseline Villalta scores were as follows: for PCDT, OR, 1.08 [95% CI, 1.01–1.15]; for control, OR, 1.20 [95% CI, 1.12–1.29]; P_interaction = .03), PTS severity (between-arm differences in the Villalta [P_interaction = .004] and Venous Clinical Severity Scale [VCSS] [P_interaction = .002)] scores), and quality of life (between-arm difference in the Venous Insufficiency Epidemiological and Economic Study Quality of Life score; P_interaction = .025). Patients with previous DVT had greater effects of PCDT on 24-month PTS severity than those in patients without previous DVT (mean [95% CI] between-arm difference in the Villalta score, 4.2 [1.56–6.84] vs 0.9 [?0.44 to 2.26], P_interaction = .03; mean [95% CI] between-arm difference in the VCSS score, 2.6 [0.94–4.21] vs 0.3 [?0.58 to 1.14], P_interaction = .02). The effects of PCDT on some but not all outcomes were greater in patients presenting with left-sided DVT (Villalta PTS severity, P_interaction = .04; venous ulcer, P_interaction = .0499) or a noncompressible popliteal vein (PTS, P_interaction = .02). The effects of PCDT did not vary by sex, race, ethnicity, body mass index, symptom duration, hypertension, diabetes, or hypercholesterolemia.ConclusionsIn patients with acute iliofemoral DVT, greater presenting clinical severity (higher baseline Villalta score) and a history of previous DVT predict enhanced benefits from PCDT.     

Experimental High-Frequency Irreversible Electroporation Using a Single-Needle Delivery Approach for Nonthermal Pancreatic Ablation In Vivo

PurposeTo investigate the feasibility of single-needle high-frequency irreversible electroporation (SN-HFIRE) to create reproducible tissue ablations in an in vivo pancreatic swine model.Materials and MethodsSN-HFIRE was performed in swine pancreas in vivo in the absence of intraoperative paralytics or cardiac synchronization using 3 different voltage waveforms (1-5-1, 2-5-2, and 5-5-5 [on-off-on times (μs)], n = 6/setting) with a total energized time of 100 μs per burst. At necropsy, ablation size/shape was determined. Immunohistochemistry was performed to quantify apoptosis using an anticleaved caspase-3 antibody. A numerical model was developed to determine lethal thresholds for each waveform in pancreas.ResultsMean tissue ablation time was 5.0 ± 0.2 minutes, and no cardiac abnormalities or muscle twitch was detected. Mean ablation area significantly increased with increasing pulse width (41.0 ± 5.1 mm² [range 32–66 mm²] vs 44 ± 2.1 mm² [range 38–56 mm²] vs 85.0 ± 7.0 mm² [range 63–155 mm²]; 1-5-1, 2-5-2, 5-5-5, respectively; p < 0.0002 5-5-5 vs 1-5-1 and 2-5-2). The majority of the ablation zone did not stain positive for cleaved caspase-3 (6.1 ± 2.8% [range 1.8–9.1%], 8.8 ± 1.3% [range 5.5–14.0%], and 11.0 ± 1.4% [range 7.1–14.2%] cleaved caspase-3 positive 1-5-1, 2-5-2, 5-5-5, respectively), with significantly more positive staining at the 5-5-5 pulse setting compared with 1-5-1 (p < 0.03). Numerical modeling determined a lethal threshold of 1114 ± 123 V/cm (1-5-1 waveform), 1039 ± 103 V/cm (2-5-2 waveform), and 693 ± 81 V/cm (5-5-5 waveform).ConclusionsSN-HFIRE induces rapid, predictable ablations in pancreatic tissue in vivo without the need for intraoperative paralytics or cardiac synchronization.     

Outcomes of Drug-Coated Balloon Angioplasty for Isolated Chronic Occlusion of the Popliteal Artery: A Retrospective Single-Institution Study

PurposeTo assess the 12-month safety and effectiveness of paclitaxel drug-coated balloon (DCB) for the treatment of patients with isolated chronic occlusions in popliteal arteries and evaluate the risk factors of lesion reocclusion.Materials and MethodsFrom January 2018 to December 2019, DCB angioplasty was performed in 54 limbs with isolated chronic popliteal artery occlusion of 48 patients (32 men) with a mean age of 71.5 ± 12.1 (range, 50–97) years, mean occlusive length of 6.3 ± 3.0 (range, 1–15) cm, and mean preoperative ankle-brachial index (ABI) of 0.42 ± 0.12 (range, 0.19–0.58). A total of 18.5% (10/54) of lesions were long-segment occlusions involving the entire popliteal artery from P1 to P3. Twenty seven of 54 limbs presented with critical limb ischemia (CLI) with a mean ABI of 0.33 ± 0.10 (range, 0.19–0.51). The primary endpoint was primary patency rate at 12 months. The secondary endpoints included technical success rate, 1-year secondary patency rate, limb salvage rate, and improvement in clinical symptoms. Univariate Cox regression analysis was used to determine the predictors of lesion reocclusion.ResultsThe technical success rate was 85.2% (46/54), and bailout stenting was performed in 14.8% (8/54) of lesions. The 12-month primary and secondary patency rates by the Kaplan–Meier estimate were 72.6% and 88.3%, respectively. Two thirds of the reocclusions occurred within 6 months after intervention. No 30-day mortality was observed. The limb salvage rate was 100% during a mean follow-up period of 13 months, and all minor amputations occurred in the limbs presented with CLI. The mean ABI increased from 0.42 before the procedure to 0.73 after the procedure. Patients younger than 60 years and the lesions exhibiting long-segment occlusions present as trending risk factors for lesion reocclusion.ConclusionsPaclitaxel DCB angioplasty is safe and effective in managing isolated chronic occlusion of popliteal arteries. Younger patients and long-segment occlusions of the popliteal artery are associated with a relatively higher reocclusion rate after the procedure.     

Outcomes of Stroke Thrombectomy Performed by Interventional Radiologists versus Neurointerventional Physicians

PurposeTo test the hypothesis that interventional radiologists (IRs) and neurointerventional (NI) physicians have similar outcomes of endovascular stroke thrombectomy (EVT), which could be used to improve the availability of thrombectomy.Materials and MethodsEight hospitals providing EVT performed by IRs and NI physicians at the same institution submitted sequential retrospective data limited to the era of modern devices. Good clinical outcomes (a 90-day modified Rankin score [mRS] of 0–2) and technically successful revascularization (a modified thrombolysis in cerebral infarction score of ≥2b) were compared between the specialties after adjusting for treating hospital, patient age, stroke severity, Alberta stroke program early computed tomography score, time from symptom onset to door, and clot location. Propensity score matching was used to compare the outcomes. A total of 1,009 patients were evaluated (622 treated by IRs and 387 treated by NI physicians).ResultsThe median time from stroke onset to puncture was 245 versus 253 minutes (P = .49), the technically successful revascularization rate was 81.8% versus 82.4% (P = .81), and the good clinical outcome rate was 45.5% versus 50.1% (P = .16). After adjusting, the physician specialty was not a significant predictor of good clinical outcomes (odds ratio, 1.028; 95% confidence interval, 0.760–1.390; P = .86). After matching, an mRS of 0–2 was present in 47.7% of IR treated patients and 51.1% of NI treated patients (P = .366).ConclusionsThere were no significant differences in the successful revascularization rate and good clinical outcomes between IRs and NI physicians. The outcomes of EVT performed by IRs were similar to those of EVT performed by NI physicians, as determined using previously published trials and registries. This may be useful for addressing coverage and access to stroke interventions.     

Evaluation of a Novel Spun Polytetrafluoroethylene Stent Graft in an Ovine External Iliac Artery Model

PurposeTo evaluate the patency, cellular response, and thrombogenicity of a novel vascular stent graft.Materials and MethodsTest stent grafts, incorporating luminal spun polytetrafluoroethylene and a nonpermeable fluoropolymer layer, and control stent grafts, constructed of permeable expanded polytetrafluoroethylene, were implanted in the external iliac arteries of 14 adult sheep with a median weight of 73.4 kg ranging from 60.6–86.8 kg for 30 (n = 4), 90 (n = 4), and 180 (n = 6) days. Angiographic patency and percent diameter stenosis (%DS) were assessed at termination. Excised stent grafts were fixed and stained for histopathologic analysis, including neointimal coverage (NC) assessment.ResultsTest and control device migration occurred in 1 animal, resulting in test device thrombosis. Both devices were excluded from analysis. Mean %DS in test and control implants was 4.6% and 8.2% (P = .563), 2.0% and 10.9% (P = .363), and 2.1% and 10.3% (P = .009) at 30, 90, and 180 days, respectively. Median NC scores at 30, 90, and 180 days were significantly lower in middle test device sections (P < .05). Proximal and distal test and control sections exhibited similar median NC scores at all time periods (P > .05). When present, test and control devices exhibited no neointimal detachment from the graft surface. Except for the migrated test device, no thrombus was observed. Transgraft cellular migration was absent in test devices but present in control devices with tissue accumulation around the stent struts.ConclusionsTest and control devices demonstrated excellent patency in an ovine model. Compared to the control, test devices exhibited significantly lower %DS values at 180 days and significantly lower mid-device NC scores at 30, 90, and 180 days.     

Partial Nephrectomy versus Percutaneous Cryoablation of Small Renal Cell Carcinomas: A Comparison of Adverse Events in a Prospective Multicenter Cohort Study

PurposeTo assess and compare complications and readmissions after partial nephrectomy and percutaneous cryoablation of cT1 renal cell carcinoma (RCC).Materials and MethodsPatients treated for cT1 RCC between 2019 and 2021 were prospectively and consecutively enrolled. Complications recorded within 30 and 90 days were graded according to the Clavien-Dindo classification, and percutaneous cryoablation was graded according to the Society of Interventional Radiology classification of adverse events. Major complications were defined as complications with a grade of ≥3 based on the Clavien-Dindo classification. Readmission within 30 days was recorded.ResultsThe cohort included 86 partial nephrectomies and 104 cryoablations. The complication rate within 90 days was 23% after partial nephrectomy and cryoablation (P = .98), with major complication rates of 3% after partial nephrectomy and 10% after cryoablation (P = .15). The readmission rates were 14% and 11% after partial nephrectomy and cryoablation, respectively (P = .48). Double-J stents were associated with overall complications (odds ratio [OR], 9.88; 95% confidence interval [CI], 2.18–44.68; P = .003) and readmissions (OR, 5.39; 95% CI, 1.37–21.06; P = .015) after cryoablation. A high versus low radius-endophytic-nearness-anterior-location score (OR, 5.86; 95% CI, 1.08–31.81; P = .040) and endophytic location (OR, 7.70; 95% CI, 1.72–34.50; P = .008) were associated with a higher complication rate after cryoablation. The Charlson Comorbidity Index (CCI) was associated with major complications after partial nephrectomy (OR, 2.12; 95% CI, 1.05–4.30; P = .036).ConclusionsPartial nephrectomy and cryoablation are comparable regarding complications within 90 days after treatment. Tumor complexity and double-J stents were associated with complications after cryoablation, and a high CCI was associated with complications after partial nephrectomy.     

Catheter-Directed Hemorrhoidal Dearterialization Technique for the Management of Hemorrhoids: A Meta-Analysis of the Clinical Evidence

PurposeTo assess the efficacy and safety of a catheter-directed hemorrhoidal dearterialization technique for the management of hemorrhoidal bleeding.Materials and MethodsA systematic review and meta-analysis of pubmed, cochrane, and scopus databases was conducted according to the preferred reporting items for systematic reviews and meta-Analysis (PRISMA) guidelines. Clinical studies reporting on catheter-directed hemorrhoidal dearterialization for rectal bleeding were analyzed.ResultsFourteen studies (n = 362) were identified. The mean maximum follow-up duration was 12.1 months (SD, 7.31; range, 1–28; median, 12), and the mean length of hospital stay was 1.5 days (SD, 1.1; range, 0–2.5). The mean technical success was 97.8% (SD, 3.5), and the mean clinical success was 78.9% (SD, 10.5). A statistically significant reduction in the french bleeding score before and after embolization was noted (P = .004). In subgroup analysis, when the coils-only group was compared with the coils and particles group, the average rebleeding rate was 21.5% (n = 111; SD, 18.2; range, 0%–44%) versus 10.05% (N = 108; SD, 4.8; range, 5%–15.7%), respectively (P < .0001). No bowel ischemia/necrosis or anorectal complications were reported.ConclusionsThe current preliminary clinical evidence suggests that catheter-directed hemorrhoidal dearterialization is an effective and safe procedure for the treatment of hemorrhoidal bleeding. The standardization of the technique and the generation of higher level evidence will be required to compare this minimally invasive procedure with more invasive surgical options for patients with grades I–III hemorrhoids and chronic bleeding.     

Sex-Related Differences in the Long-Term Outcomes of Patients with Femoropopliteal Arterial Disease Treated with the IN.PACT Drug-Coated Balloon in the IN.PACT SFA Randomized Controlled Trial: A Post Hoc Analysis

PurposeTo evaluate sex-related disparities in long-term outcomes of patients with peripheral artery disease (PAD) treated with IN.PACT drug-coated balloon (DCB) or percutaneous transluminal angioplasty (PTA).Materials and MethodsA post hoc analysis of the IN.PACT SFA trial was performed. Participants with Rutherford Clinical Classification 2–4 PAD and femoropopliteal artery lesions up to 18 cm long were randomly assigned to treatment with DCB (n = 220) or PTA (n = 111). Effectiveness outcomes were evaluated, including 36-month primary patency (freedom from binary restenosis and freedom from clinically driven [CD] target lesion revascularization [TLR]).ResultsIn the DCB group, women were significantly older (69.4 y ± 9.9) than men (66.4 y ± 9.1; P = .025). Mean reference vessel diameter (RVD) was significantly smaller in women (4.4 mm ± 0.68) compared with men (4.8 mm ± 0.89, P < .001). Primary patency was 65.4% in women and 71.8% in men (P = .302). Freedom from CD-TLR was 81.1% in women and 86.4% in men (P = .285). Women treated with PTA were older (70.4 y ± 8.3) than men (66.9 y ± 9.5; P = .063). Mean RVD was significantly smaller in women (4.2 mm ± 0.77) compared with men (4.9 mm ± 0.77, P < .001). Primary patency was 42.3% in women and 46.7% in men (P = .551). Freedom from CD-TLR was 59.4% in women and 75.5% in men (P = .109). No significant differences were noted in safety and mortality outcomes.ConclusionsIn both groups, women were older and had smaller vessels. Particularly in the PTA group, women had worse clinical outcomes, though not reaching statistical significance. Further evaluation is necessary to understand the disparate nature of disease progression and outcomes following endovascular treatment in women compared with men.