Methods, design, and initial results of an angiographic core lab from VOYAGER-PAD.

Background: Anatomy is critical in risk stratification and therapeutic decision making in coronary disease. The relationship between anatomy and outcomes is not well described in PAD. We sought to develop an angiographic core lab within the VOYAGER-PAD trial. The current report describes the methods of creating this core lab, its study population, and baseline anatomic variables. Methods: Patients undergoing lower-extremity revascularization for symptomatic PAD were randomized in VOYAGER-PAD. The median follow up was 2.25 years. Events were adjudicated by a blinded Clinical Endpoint Committee. Angiograms were collected from study participants; those with available angiograms formed this core lab cohort. Angiograms were scored for anatomic and flow characteristics by trained reviewers blinded to treatment. Ten percent of angiograms were evaluated independently by two reviewers; inter-rater agreement was assessed. Clinical characteristics and the treatment effect of rivaroxaban were compared between the core lab cohort and noncore lab participants. Anatomic data by segment were analyzed. Results: Of 6564 participants randomized in VOYAGER-PAD, catheter-based angiograms from 1666 patients were obtained for this core lab. Anatomic and flow characteristics were collected across 16 anatomic segments by 15 reviewers. Concordance between reviewers for anatomic and flow variables across segments was 90.5% (24,417/26,968). Clinical characteristics were similar between patients in the core lab and those not included. The effect of rivaroxaban on the primary efficacy and safety outcomes was also similar. Conclusions: The VOYAGER-PAD angiographic core lab provides an opportunity to correlate PAD anatomy with independently adjudicated outcomes and provide insights into therapy for PAD. (ClinicalTrials.gov Identifier: NCT02504216).

Utility of Intravascular US-Guided Portal Vein Access during Transjugular Intrahepatic Portosystemic Shunt Creation: Retrospective Comparison with Conventional Technique in 109 Patients.

PURPOSE: To compare safety and effectiveness of intravascular ultrasound (US)-guided portal vein access during transjugular intrahepatic portosystemic shunt (TIPS) creation with conventional TIPS technique. MATERIALS AND METHODS: In this retrospective study, TIPS creation using intravascular US guidance in 55 patients was compared with conventional TIPS creation in 54 patients by 10 operators over a 3-year period. Operators were classified as experienced if they had performed ≥ 20 TIPS procedures at the beginning of the study period. Time to portal vein access, total radiation dose, and needle pass-related capsular perforation were recorded. RESULTS: Baseline demographic characteristics of patients were similar (P > .05). Mean time to portal venous access was 46 minutes ± 37 for conventional TIPS and 31 minutes ± 19 for intravascular US-guided TIPS (P = .007). Intravascular US guidance allowed significantly shorter times (48 min ± 30 vs 28 min ± 16; P = .01) to portal vein access among operators (n = 5) with limited experience but failed to achieve any significant time savings (44 min ± 43 vs 34 min ± 22; P = .89) among experienced operators (n = 5). Needle pass-related capsular perforation occurred in 17/54 (34%) patients with conventional TIPS and 5/55 (9%) patients with intravascular US-guided TIPS (P = .004). Radiation dose was 2,376 mGy ± 1,816 for conventional TIPS and 1,592 mGy ± 1,263 for intravascular US-guided TIPS (P = .004). CONCLUSIONS: Intravascular US-guided portal vein access during TIPS creation is associated with shorter portal vein access times, decreased needle pass-related capsular perforations, and reduced radiation dose.

Systemic Vasculopathies: Imaging and Management.

Systemic vasculopathies represent a wide spectrum of heterogeneous vascular disorders characterized by variable target vessel involvement, vascular abnormalities, and end organ damage. The revised 2012 Chapel Hill Consensus Conference scheme classifies systemic vasculitis syndromes into primary systemic, secondary systemic, single-vessel, and variable-vessel vasculitis categories with associated management implications. Multimodality imaging not only allows diagnosis, characterization, and localization of vascular abnormalities but also permits evaluation of natural history and complications, thus, facilitating optimal patient management. This article discusses epidemiologic and radiologic characteristics of several common systemic vasculopathies with an emphasis on the role of endovascular therapy for management of select disorders.

Effect of technical parameters on transjugular intrahepatic portosystemic shunts utilizing stent grafts.

AIM: To assess the effect of technical parameters on outcomes of transjugular intrahepatic portosystemic shunt (TIPS) created using a stent graft. METHODS: The medical records of 68 patients who underwent TIPS placement with a stent graft from 2008 to 2014 were reviewed by two radiologists blinded to the patient outcomes. Digital Subtraction Angiographic images with a measuring catheter in two orthogonal planes was used to determine the TIPS stent-to-inferior vena cava distance (SIVCD), hepatic vein to parenchymal tract angle (HVTA), portal vein to parenchymal tract angle (PVTA), and the accessed portal vein. The length and diameter of the TIPS stent and the use of concurrent variceal embolization were recorded by review of the patient's procedure note. Data on re-intervention within 30 d of TIPS placement, recurrence of symptoms, and survival were collected through the patient's chart. Cox proportional regression analysis was performed to assess the effect of these technical parameters on primary patency of TIPS, time to recurrence of symptoms, and all-cause mortality. RESULTS: There was no significant association between the SIVCD and primary patency (P = 0.23), time to recurrence of symptoms (P = 0.83), or all-cause mortality (P = 0.18). The 3, 6, and 12-mo primary patency rates for a SIVCD ≥ 1.5 cm were 82.4%, 64.7%, and 50.3% compared to 89.3%, 83.8%, and 60.6% for a SIVCD of < 1.5 cm (P = 0.29). The median time to stenosis for a SIVCD of ≥ 1.5 cm was 19.1 mo vs 15.1 mo for a SIVCD of < 1.5 cm (P = 0.48). There was no significant association between the following factors and primary patency: HVTA (P = 0.99), PVTA (P = 0.65), accessed portal vein (P = 0.35), TIPS stent diameter (P = 0.93), TIPS stent length (P = 0.48), concurrent variceal embolization (P = 0.13) and reinterventions within 30 d (P = 0.24). Furthermore, there was no correlation between these technical parameters and time to recurrence of symptoms or all-cause mortality. Recurrence of symptoms was associated with stent graft stenosis (P = 0.03). CONCLUSION: TIPS stent-to-caval distance and other parameters have no significant effect on primary patency, time to recurrence of symptoms, or all-cause mortality following TIPS with a stent-graft.