Treatment of locally advanced pancreatic cancer using localized trans-arterial micro perfusion of gemcitabine: combined analysis of RR1 and RR2.

BACKGROUND: Locally advanced pancreatic cancer (LAPC) comprises 40% of pancreatic cancer diagnoses and has a relatively poor prognosis. Trans-arterial micro perfusion (TAMP)-mediated chemotherapy delivery to the primary tumor is a novel approach worthy of investigation. The RR1 (dose escalation) and RR2 (observational) studies examined the safety and preliminary efficacy of TAMP-delivered gemcitabine for LAPC. PATIENTS AND METHODS: RR1 and RR2 data were pooled. Both studies enrolled patients with LAPC with histologically confirmed adenocarcinoma. Participant data, including age, sex, race, stage, previous treatments, toxicity, disease progression, and death, were collected. Median number of cycles and average treatment dosage were calculated. Overall survival (OS) was determined for the whole group and separately for patients who received and did not receive previous treatments. Aims of the analysis were to assess procedure safety, OS, and evaluate factors associated with OS. RESULTS: The median age of the 43 patients enrolled in RR1 and RR2 was 72 years (range, 51-88 years). Median OS for the 35 eligible patients with stage III disease was 12.6 months (95% CI, 2.1-54.2 months). Previous chemoradiation was associated with significantly longer OS [27.1 months (95% CI, 8.4-40.6 months)] compared to previous systemic chemotherapy [14.6 months (95% CI, 6.4-54.2 months)] or no prior treatment [7.0 months (95% CI, 2.1-35.4 months)] (P < .001). The most common adverse events were GI related (abdominal pain, emesis, and vomiting); the most common grade 3 toxicity was sepsis. CONCLUSION: Study results indicate that TAMP-mediated gemcitabine delivery in patients with LAPC is potentially safe, feasible, and provides potential clinical benefits. CLINICAL TRIAL REGISTRATION: NCT02237157 (RR1) and NCT02591082 (RR2).

Double-Balloon Catheter-Mediated Transarterial Chemotherapy Delivery in a Swine Model: A Mechanism Recruiting the Vasa Vasorum for Localized Therapies.

PURPOSE: Treatment of hypovascular tumors, such as pancreatic adenocarcinoma, is challenging owing to inefficient drug delivery. This report examines the potential mechanism of localized drug delivery via transarterial microperfusion (TAMP) using a proprietary adjustable double-balloon occlusion catheter in a porcine model. MATERIALS AND METHODS: Adult Yorkshire swine (N = 21) were used in the Institutional Animal Care & Use Committee-approved protocols. The RC-120 catheter (RenovoRx, Los Altos, California) was positioned into visceral, femoral, and pulmonary arteries with infusion of methylene blue dye, gemcitabine, or gold nanoparticles. Transmural delivery was compared under double-balloon occlusion with and without side-branch exclusion, single-balloon occlusion, and intravenous delivery. Intra-arterial pressure and vascular histologic changes were assessed. RESULTS: Infusion with double-balloon occlusion and side-branch exclusion provided increased intra-arterial pressure in the isolated segment and enhanced perivascular infusate penetration with minimal vascular injury. Infusates were predominantly found in the vasa vasorum by electron microscopy. CONCLUSIONS: TAMP enhanced transmural passage mediated by localized increase in arterial pressure via vasa vasorum.

Revisiting Spinal Cord Infarction after Bronchial Artery Embolization.

It is unusual to write a letter to the editor of the Journal of Vascular and Interventional Radiology about an article published in a different journal. Unfortunately, this important article has gone relatively unnoticed in the interventional radiology community. The author's hope is that this letter draws attention to this rare, severe complication related to BAE. Superselective coil embolization for BAE should be revisited and studied to demonstrate its true effectiveness and complication rate. Ultimately, patients and their physicians must decide whether they want to incur a higher risk of paraplegia versus a potentially higher risk of recurrence and death.

The Use of the Transfemoral Transcaval Liver Biopsy Technique for Biopsies of Hepatic Masses.

The purpose of this study was to investigate the safety and effectiveness of the transfemoral transcaval (TFTC) liver biopsy technique in patients with hepatic masses with relative contraindications to percutaneous biopsy and/or mass location abutting the inferior vena cava. The medical records of 16 patients (56% men; age range, 21-88 years) who underwent TFTC biopsy of hepatic masses (ranging in diameter from 2.1 to 13.2 cm) from September 2015 to August 2021 were reviewed. Histopathologic diagnoses were made in 15 of 17 (88%) procedures. Two adverse events were noted: worsened preexisting hemobilia requiring embolization in 1 patient, and a decrease in hematocrit level in another patient, requiring only observation. In conclusion, this report showed that the TFTC technique is a relatively safe and effective method for sampling hepatic masses in select cases.

Efficacy of Uterine Artery Embolization for Treatment of Anticoagulant-Associated Abnormal Uterine Bleeding.

STUDY OBJECTIVE: Data regarding uterine artery embolization (UAE) to specifically treat anticoagulant-associated iatrogenic abnormal uterine bleeding (AUB-I) are sparse. This manuscript aimed to quantify the effectiveness of UAE in treating this subset of patients. DESIGN: Retrospective case series. SETTING: Academic hospital serving a large minority-majority population. PATIENTS: Twenty-four patients with AUB-I that was provoked or aggravated by the initiation of anticoagulation therapy. INTERVENTIONS: Treatment of anticoagulant-associated AUB-I that failed medical management or was acute with UAE rather than inferior vena cava filter placement and hysterectomy. MEASUREMENTS AND MAIN RESULTS: An imaging database search was performed to identify patients who underwent UAE for anticoagulant-associated AUB-I from May 2011 to July 2020. Medical and radiologic records were reviewed. Short- and long-term outcomes were obtained to date, ranging from 10 months to 10 years after the procedure. In total, 24 patients were identified, ranging in age from 35 to 54 (mean 44.9) years. Venous thromboembolic disease was the most common (92%) indication for anticoagulation. At presentation, 14 patients (58%) were anticipated to require lifelong anticoagulation. Most UAE procedures (54%) occurred within 10 days of anticoagulation initiation. Before UAE, 17 patients (71%) attempted and failed medical management, myomectomy, or endometrial ablation to control bleeding. After UAE, 21 patients (88%) experienced substantial improvement or resolution of AUB and continued anticoagulation therapy. Three patients (14%) did not experience improvement and were treated with hysterectomy. Amenorrhea immediately after UAE occurred in 1 patient at age 45. CONCLUSION: UAE was an effective tool in the management of anticoagulant associated AUB-I in this cohort, resulting in decreased bleeding while allowing the continuation of anticoagulation therapy, with high rates of uterine preservation and preserved menses.

Transjugular versus Transfemoral Transcaval Liver Biopsy: A Single-Center Experience in 500 Cases.

PURPOSE: To compare the safety and efficacy of transfemoral transcaval liver biopsies (TFTC) with that of transjugular liver biopsies (TJLB) at a single tertiary-care institution. MATERIALS AND METHODS: A retrospective review was performed of 500 consecutive transvenous liver biopsies between December 2010 and December 2018. The cases included 286 TFTC patients at a median age of 54 years old (interquartile range [IQR], 42-63 years of age), 37.4% were female; and 214 TJLB patients at a median age of 55 years old (IQR, 46-61 years of age), 45.4% female. Patient demographic and laboratory data and technical and histopathological success, fluoroscopy times, and complications were recorded. Comparative statistical analyses were performed using a 2-sample test or a Wilcoxon ranked sum test for continuous variables and a chi-square test or Fisher exact test for categorical variables when appropriate. RESULTS: TFTC and TJLB data are presented as: technical success rates of 99.3% (283 of 286) and 100% (214 of 214), respectively; histopathologic success rates of 96.5% (275 of 285) and 95.8% (205 of 214), respectively; and major complication rates of 1.4% (4 of 284) and 5.6% (12 of 214), respectively (P = .009). There were no hepatic injuries in the TFTC group, whereas the TJLB group included 6 significant hepatic injuries requiring intervention. Median fluoroscopic times were 5.5 minutes (IQR, 3.9-8.6 minutes) for TFTC and 8.1 minutes (IQR, 5.2-13.1) for TJLB (P < .001). CONCLUSIONS: In this single-institution study, TFTC was associated with a lower major complication rate and lower fluoroscopy times than conventional TJLB with similar technical and histopathologic successes.

The Role of Non-Contrast Cone Beam CT in Identifying Incomplete Treatment during Uterine Artery Embolization.

PURPOSE: To describe the utility of post-procedure noncontrast cone-beam computed tomography (CT) in identifying cases of incomplete treatment and the need to search for additional vascular supply during uterine artery embolization (UAE). MATERIALS AND METHODS: From June 2013 to June 2018, 427 patients (age, 45 ± 5 years) underwent 430 consecutive UAEs with post-embolization noncontrast cone-beam CT. If noncontrast cone-beam CT showed an area of the uterus lacking contrast retention, aortography was performed to search for collateral supply. Procedures were characterized as suspected complete bilateral UAEs or suspected incomplete UAEs, such as in cases of a unilateral uterine artery or diminutive uterine arteries. Rates of inadequate contrast retention on noncontrast cone-beam CT and discovered collateral artery supply were calculated. In 10 consecutive cases in which both noncontrast cone-beam CT and aortography were performed, dose-area product radiation exposure from noncontrast cone-beam CT and aortography was compared using a 2-sided paired-sample t-test. RESULTS: Of the 411 suspected complete bilateral UAEs, noncontrast cone-beam CT showed an area of the uterus lacking contrast retention in 38 (9.2%) cases. Of the 19 suspected incomplete UAEs, noncontrast cone-beam CT demonstrated incomplete treatment in 6 (31.6%) patients. Aortography was performed in 40 of the 44 cases of incomplete treatment on noncontrast cone-beam CT, and collateral supply was found in 28 (70.0%) cases. In 22 of these cases (5.2% of the 427 patients studied), noncontrast cone-beam CT led to the discovery of significant collateral supply requiring further embolization. Dose-area product radiation exposure from noncontrast cone-beam CT was less than from aortography (P = .007). CONCLUSIONS: Post-UAE noncontrast cone-beam CT can be used to select a subset of patients with a higher likelihood of collateral supply who may benefit from post-embolization aortography.

Transfemoral Transcaval Core-Needle Liver Biopsy: An Alternative to Transjugular Liver Biopsy.

PURPOSE: To describe the technique and outcome of transfemoral transcaval (TFTC) core-needle liver biopsies. MATERIALS AND METHODS: Retrospective chart review was performed on 121 patients who underwent transvenous liver biopsies at a single institution between February 2014 and July 2015, yielding 66 total TFTC liver biopsies for review (65.2% male; mean age, 53.2 y ± 15.0). From August 2014 through July 2015, TFTC biopsies accounted for 64 of 77 (83%) transvenous biopsies. Hepatic tissue was obtained directly through the intrahepatic inferior vena cava from a femoral venous approach. Procedural complications were classified according to Society of Interventional Radiology guidelines. RESULTS: Of the 66 biopsies, technical success was achieved in 64 cases (97.0%). Histopathologic diagnoses were made in 63 cases (95.5%). Fragmented or limited specimens in which a pathologic diagnosis was still made occurred in four cases (6.1%). Complications occurred in two cases (3.0%). Venous pressure measurements were requested in 60 cases, and all were successfully obtained. CONCLUSIONS: TFTC core-needle liver biopsies are feasible and safe as demonstrated in this series of patients.

Early endovascular grafts at Montefiore Hospital and their effect on vascular surgery.

Vascular surgery is very fortunate. It recognized the transition from open surgery to endovascular procedures as treatments for vascular disease early enough to adapt as a specialty. As a result, most vascular surgeons in North America became competent with endovascular techniques, and the survival of the specialty was assured. The endovascular graft program at Montefiore Hospital played a major role in vascular surgery's early recognition of the importance of the endovascular revolution. This article will review the history of this early endovascular graft program and how it influenced the specialty.

Transfemoral-Transcaval Liver Biopsy (TFTC) and Transjugular Liver Biopsy (TJLB) in Patients with Fontan-Associated Liver Disease (FALD).

PURPOSE: To describe our experience in performing transfemoral-transcaval liver biopsy (TFTC) and transjugular liver biopsy (TJLB) in patients with Fontan-associated liver disease (FALD). METHODS: A single-center, retrospective review of 23 TFTC and seven TJLB performed between August 2011 and May 2023 on patients who previously underwent the Fontan procedure (median age 23.1 years, ranging 11-43 years, 48% female). Patient demographics, laboratory values, pathology, radiology, and cardiology reports were reviewed. Liver explants were correlated with histopathological evaluation to determine sampling accuracy when available. RESULTS: All biopsies achieved technical success (accurate targeting and safe tissue sample extraction) and histopathological success (yielding sufficient tissue for accurate diagnosis). Liver biopsies were performed during simultaneous cardiac catheterization in 28 of 30 (93%) procedures. There was no statistically significant change in hemoglobin, hematocrit, platelet count post-procedure, and fluoroscopy times. There was one major complication within the TJLB group and one minor complication within the TFTC group. CONCLUSION: Transvenous liver biopsies, whether via transfemoral or transjugular route, may be safely performed in FALD patients while yielding samples with technical and histopathological success. The transfemoral approach, which is our preferred method; its compatibility with simultaneous cardiac catheterization and its potentially increased safety profile stemming from the avoidance of transversing the Fontan shunt-makes it a particular advantageous option in the management of FALD.

Value of noncontrast CT immediately after transarterial chemoembolization of hepatocellular carcinoma with drug-eluting beads.

PURPOSE: To retrospectively evaluate the presence and distribution patterns of contrast agent retention in the liver on noncontrast computed tomography (CT) immediately following chemoembolization with drug-eluting beads (DEBs). MATERIALS AND METHODS: From 2008 to 2010, 95 patients with 224 liver lesions had chemoembolization performed with DEBs and a noncontrast CT examination of the liver performed immediately after embolization. Of these, 85 patients with 193 lesions were included. The postembolization CT scan was reviewed by a diagnostic radiologist, and the presence of contrast agent retention within the lesion was assessed. Varying patterns of contrast agent retention were defined. RESULTS: Of the 193 lesions included, 146 (76%) retained contrast medium. Aside from some contrast medium in vessels, very little if any contrast medium was seen in the surrounding liver. Various patterns of contrast agent retention were noted within lesions. In a single case, repeat imaging was obtained 6 hours later, which demonstrated washout of contrast agent in a lesion that had retained contrast agent on the postprocedure CT scan. Of significance, 13 additional foci of contrast agent retention were identified on postchemoembolization CT scans that, on retrospective review of preprocedure imaging, represented enhancing lesions not previously identified. CONCLUSIONS: Noncontrast CT after chemoembolization with DEBs demonstrates contrast agent retention in 76% of cases, without significant contrast medium seen in the adjacent liver parenchyma. The presence or absence of contrast agent retention may prove to be useful in evaluating accurate targeting of a lesion.

Association of Addition of Ablative Therapy Following Transarterial Chemoembolization With Survival Rates in Patients With Hepatocellular Carcinoma.

Importance: Hepatocellular carcinoma (HCC) is a heterogeneous disease with many available treatment modalities. Transarterial chemoembolization (TACE) is a valuable treatment modality for HCC lesions. This article seeks to evaluate the utility of additional ablative therapy in the management of patients with HCC who received an initial TACE procedure. Objective: To compare the overall survival (OS) and freedom from local progression (FFLP) outcomes after TACE alone with TACE that is followed by an ablative treatment regimen using stereotactic body radiation therapy, radiofrequency ablation, or microwave ablation for patients with HCC. Design, Setting, and Participants: This cohort study of 289 adults at a single urban medical center examined survival outcomes for patients with nonmetastatic, unresectable HCC who received ablative therapies following TACE or TACE alone from January 2010 through December 2018. The Lee, Wei, Amato common baseline hazard model was applied for within-patient correlation with robust variance and Cox regression analysis was used to assess the association between treatment group (TACE vs TACE and ablative therapy) and failure time events (FFLP per individual lesion and OS per patient), respectively. In both analyses, the treatment indication was modeled as a time-varying covariate. Landmark analysis was used as a further sensitivity test for bias by treatment indication. Exposures: TACE alone vs TACE followed by ablative therapy. Main Outcomes and Measures: Freedom from local progression and overall survival. Hypotheses were generated before data collection. Results: Of the 289 patients identified, 176 (60.9%) received TACE only and 113 (39.1%) received TACE plus ablative therapy. Ablative therapy included 45 patients receiving stereotactic body radiation therapy, 39 receiving microwave ablation, 20 receiving radiofrequency ablation, and 9 receiving a combination of these following TACE. With a median (interquartile range) follow-up of 17.4 (9.5-29.5) months, 242 of 512 (47.3%) lesions progressed, 211 in the group with TACE alone and 31 in the group with TACE plus ablative therapy (P < .001). Over 3 years, FFLP was 28.1% for TACE alone vs 67.4% for TACE with ablative therapy (P < .001). The 1-year and 3-year OS was 87.5% and 47.1% for patients with lesions treated with TACE alone vs 98.7% and 85.3% for patients where any lesion received TACE plus ablative therapy, respectively (P = .01), and this benefit remained robust on landmark analyses at 6 and 12 months. The addition of ablative therapy was independently associated with OS on multivariable analysis for all patients (hazard ratio, 0.26; 95% CI, 0.13-0.49; P < .001) and for patients with Barcelona clinic liver cancer stage B or C disease (hazard ratio, 0.31; 95% CI, 0.14-0.69; P = .004). Conclusions and Relevance: Adding ablative therapy following TACE improved FFLP and OS among patients with hepatocellular carcinoma. This study aims to guide the treatment paradigm for HCC patients until results from randomized clinical trials become available.

Centers with more therapeutic modalities are associated with improved outcomes for patients with hepatocellular carcinoma.

BACKGROUND: Higher facility volume is correlated to better overall survival (OS), but there is little knowledge on the effect of facility treatment modality number on OS in hepatocellular carcinoma (HCC). METHODS: This is a retrospective analysis of data from the National Cancer Database (NCDB) from 2004-2014 on patients with non-metastatic HCC. Treatment modalities assessed were surgical resection, transplantation, ablation, radioembolization, stereotactic body radiation therapy (SBRT), single-agent chemotherapy, and multi-agent chemotherapy. Facilities were dichotomized at the median of the listed treatment modalities. RESULTS: There were a total of 112,512 patients with non-metastatic HCC. Of a total of 1,230 sites, 830 (67.5%) used four or fewer modalities. Average survival for patients treated at facilities using fewer modalities was 12.0 and 23.5 months for those treated at facilities with more modalities [hazard ratio (HR) =0.52, 95% confidence interval (CI): 0.51-0.53, P<0.001]. After adjusting for facility volume, liver function, tumor and patient characteristics and other prognostic factors in a multivariable Cox model, treatment at a multi-modality facility still provided a survival advantage (HR =0.60, 95% CI: 0.52-0.70, P<0.001). This benefit also persisted after propensity score matching. Sensitivity analysis varying the cut point from 2 to 6 modalities for dichotomization showed that the benefit persisted. Subgroup stratified analyses based on stage showed that the benefit in OS was highest for patients with stage I and II (P≤0.002) but was not significant for stage III or IVa. CONCLUSIONS: Institutions that offered more treatment modalities had improved OS for patients with non-metastatic HCC, especially for those with stage I and II.

Catheter directed interventions for inferior vena cava thrombosis.

Inferior vena cava (IVC) thrombosis, although similar in many aspects to deep venous thrombosis (DVT), has distinct clinical implications, treatments and roles for endovascular management. Etiologies of IVC thrombosis vary from congenital malformations of the IVC to acquired, where indwelling IVC filters have been implicated as a leading cause. With an increasing incidence of IVC thrombosis throughout the United States, clinicians need to be educated on the clinical signs and diagnostic tools available to aid in the diagnosis as well as available treatment options. Untreated IVC thrombus can result in serious morbidity and mortality, both in the acute phase with symptoms related to venous outflow occlusion and embolism, and in the long-term, sequelae of post-thrombotic syndrome (PTS) related to chronic venous occlusion. This manuscript will discuss the clinical presentation of IVC thrombosis, diagnostic and treatment options, as well as the role of endovascular management.

A Prospective, Single-Arm, Multicenter Trial of Ultrasound-Facilitated, Catheter-Directed, Low-Dose Fibrinolysis for Acute Massive and Submassive Pulmonary Embolism: The SEATTLE II Study.

OBJECTIVES: This study conducted a prospective, single-arm, multicenter trial to evaluate the safety and efficacy of ultrasound-facilitated, catheter-directed, low-dose fibrinolysis, using the EkoSonic Endovascular System (EKOS, Bothell, Washington). BACKGROUND: Systemic fibrinolysis for acute pulmonary embolism (PE) reduces cardiovascular collapse but causes hemorrhagic stroke at a rate exceeding 2%. METHODS: Eligible patients had a proximal PE and a right ventricular (RV)-to-left ventricular (LV) diameter ratio ≥0.9 on chest computed tomography (CT). We included 150 patients with acute massive (n = 31) or submassive (n = 119) PE. We used 24 mg of tissue-plasminogen activator (t-PA) administered either as 1 mg/h for 24 h with a unilateral catheter or 1 mg/h/catheter for 12 h with bilateral catheters. The primary safety outcome was major bleeding within 72 h of procedure initiation. The primary efficacy outcome was the change in the chest CT-measured RV/LV diameter ratio within 48 h of procedure initiation. RESULTS: Mean RV/LV diameter ratio decreased from baseline to 48 h post-procedure (1.55 vs. 1.13; mean difference, -0.42; p < 0.0001). Mean pulmonary artery systolic pressure (51.4 mm Hg vs. 36.9 mm Hg; p < 0.0001) and modified Miller Index score (22.5 vs. 15.8; p < 0.0001) also decreased post-procedure. One GUSTO (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries)-defined severe bleed (groin hematoma with transient hypotension) and 16 GUSTO-defined moderate bleeding events occurred in 15 patients (10%). No patient experienced intracranial hemorrhage. CONCLUSIONS: Ultrasound-facilitated, catheter-directed, low-dose fibrinolysis decreased RV dilation, reduced pulmonary hypertension, decreased anatomic thrombus burden, and minimized intracranial hemorrhage in patients with acute massive and submassive PE. (A Prospective, Single-arm, Multi-center Trial of EkoSonic® Endovascular System and Activase for Treatment of Acute Pulmonary Embolism (PE) [SEATTLE II]; NCT01513759).

Thrombolysis for the treatment of thrombosed hemodialysis access grafts.

Maintaining the patency of hemodialysis access grafts remains problematic. It is best to recognize the failing graft prior to its thrombosis by noting an increase in recirculation, decreased flow (as measured by a Transonics device), changes in Doppler ultrasound findings, elevation of venous pressures, or swelling of the arm. If a failing graft is suspected, an angiogram should be performed to evaluate the graft. If a problem is identified it should be corrected. If it is a graft thrombosis, it can be opened using percutaneous techniques. Percutaneous declotting has been evolving since its introduction in the early 1980s. At first, a low-dose thrombolytic infusion through a single catheter was used. Crossing catheters with a higher-dose infusion was then introduced. Finally, pharmacomechanical thrombolysis, which used crossing catheters and a pulse-spray technique, became popular. Several mechanical devices have proven to be efficacious as well. In 1997, we described the "lyse-and-wait" technique. We believe "lyse and wait" to be a simpler and quicker technique, and its initial success has been similar to that for the previously described techniques. After the graft is successfully declotted, the arterial plug must be mobilized and the stenotic lesion must be addressed either by angioplasty, stent placement, surgery, or any combination of these interventions.