One-Year Results with a Low-Profile Endograft in Subjects with Thoracic Aortic Aneurysm and Ulcer Pathologies

Objective Evaluate safety and effectiveness of the second generation, low-profile RelayPro thoracic endograft for the treatment of descending thoracic aortic aneurysm or penetrating atherosclerotic ulcer (PAU). Method A prospective, international, non-blinded, non-randomized, pivotal trial analyzed a primary safety endpoint of major adverse events (MAE) at 30 days (death, myocardial infarction, stroke, renal/respiratory failure, paralysis, bowel ischemia, procedural blood loss), and a primary effectiveness endpoint of treatment success at one year (technical success, patency, absence of aneurysm rupture, type I/III endoleaks, stent fractures, reinterventions, aneurysm expansion, and migration) compared to performance goals from the previous generation Relay pivotal study. The study was conducted in 36 centers in the US and Japan and enrolled between 2017 and 2019. Results The study population of 110 patients had a median (IQR) age of 76 (70 – 81) years, n=69 (62.7%) were male, n=43 (39.1%) were Asian, and were treated for 76 fusiform aneurysms (69%), 24 saccular aneurysms (22%), and 10 PAUs (9%). Most patients (82.7%) were treated with a non-bare stent (NBS) configuration. Technical success was 100%: median (IQR) procedure time was 91 (64 – 131) min, deployment time was 16 (10 – 25) min; 50 patients (73.5%) of the US cohort had percutaneous access, while centers in Japan used only surgical cutdown. The 30-day composite MAE rate was 6.4% (95% upper CI 11.6%, p=.0002): 2 strokes, 2 procedural blood losses >1000 mL requiring transfusion, 2 paralysis events, and 1 renal failure. Primary effectiveness was 89.2% (lower 95% CI 81.8%, p=.0185): 9 subjects experienced 11 events (1 aneurysm expansion, 6 secondary interventions, 4 type I endoleaks). There was no loss of stent-graft patency, no rupture, no fractures, and no migration. Conclusions The low-profile RelayPro thoracic endograft met the study primary endpoints and demonstrated satisfactory 30-day safety and 1-year effectiveness for the treatment of patients with aneurysms of the descending thoracic aorta or PAUs. Follow-up is ongoing to evaluate longer term outcomes and durability

Endovascular Thrombus Removal for Acute Iliofemoral Deep Vein Thrombosis.

BACKGROUND: The ATTRACT trial (Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis) previously reported that pharmacomechanical catheter-directed thrombolysis (PCDT) did not prevent postthrombotic syndrome (PTS) in patients with acute proximal deep vein thrombosis. In the current analysis, we examine the effect of PCDT in ATTRACT patients with iliofemoral deep vein thrombosis. METHODS: Within a large multicenter randomized trial, 391 patients with acute deep vein thrombosis involving the iliac or common femoral veins were randomized to PCDT with anticoagulation versus anticoagulation alone (No-PCDT) and were followed for 24 months to compare short-term and long-term outcomes. RESULTS: Between 6 and 24 months, there was no difference in the occurrence of PTS (Villalta scale ≥5 or ulcer: 49% PCDT versus 51% No-PCDT; risk ratio, 0.95; 95% CI, 0.78-1.15; P=0.59). PCDT led to reduced PTS severity as shown by lower mean Villalta and Venous Clinical Severity Scores ( P0.2 for comparisons of SF-36 mental and physical component summary scores through 24 months). In patients having PCDT versus No-PCDT, major bleeding within 10 days occurred in 1.5% versus 0.5% ( P=0.32), and recurrent venous thromboembolism over 24 months was observed in 13% versus 9.2% ( P=0.21). CONCLUSIONS: In patients with acute iliofemoral deep vein thrombosis, PCDT did not influence the occurrence of PTS or recurrent venous thromboembolism. However, PCDT significantly reduced early leg symptoms and, over 24 months, reduced PTS severity scores, reduced the proportion of patients who developed moderate-or-severe PTS, and resulted in greater improvement in venous disease-specific quality of life. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00790335

Managing central venous access during a health care crisis.

ObjectiveDuring the COVID-19 pandemic, central venous access line teams were implemented at many hospitals throughout the world to provide access for critically ill patients. The objective of this study was to describe the structure, practice patterns, and outcomes of these vascular access teams during the COVID-19 pandemic.MethodsWe conducted a cross-sectional, self-reported study of central venous access line teams in hospitals afflicted with the COVID-19 pandemic. To participate in the study, hospitals were required to meet one of the following criteria: development of a formal plan for a central venous access line team during the pandemic; implementation of a central venous access line team during the pandemic; placement of central venous access by a designated practice group during the pandemic as part of routine clinical practice; or management of an iatrogenic complication related to central venous access in a patient with COVID-19.ResultsParticipants from 60 hospitals in 13 countries contributed data to the study. Central venous line teams were most commonly composed of vascular surgery and general surgery attending physicians and trainees. Twenty sites had 2657 lines placed by their central venous access line team or designated practice group. During that time, there were 11 (0.4%) iatrogenic complications associated with central venous access procedures performed by the line team or group at those 20 sites. Triple lumen catheters, Cordis (Santa Clara, Calif) catheters, and nontunneled hemodialysis catheters were the most common types of central venous lines placed by the teams. Eight (14%) sites reported experience in placing central venous lines in prone, ventilated patients with COVID-19. A dedicated line cart was used by 35 (59%) of the hospitals. Less than 50% (24 [41%]) of the participating sites reported managing thrombosed central lines in COVID-19 patients. Twenty-three of the sites managed 48 iatrogenic complications in patients with COVID-19 (including complications caused by providers outside of the line team or designated practice group).ConclusionsImplementation of a dedicated central venous access line team during a pandemic or other health care crisis is a way by which physicians trained in central venous access can contribute their expertise to a stressed health care system. A line team composed of physicians with vascular skill sets provides relief to resource-constrained intensive care unit, ward, and emergency medicine teams with a low rate of iatrogenic complications relative to historical reports. We recommend that a plan for central venous access line team implementation be in place for future health care crises

Managing central venous access during a health care crisis

10.1016/j.jvs.2020.06.112JOURNAL OF VASCULAR SURGERY7241184-