Outpatient management of cancer-associated pulmonary embolism: A post-hoc analysis from the HOME-PE trial.

INTRODUCTION: Cancer-related pulmonary embolism (PE) is associated with poor prognosis. Some decision rules identifying patients eligible for home treatment categorize cancer patients at high risk of complications, precluding home treatment. We sought to assess the effectiveness and the safety of outpatient management of patients with low-risk cancer-associated PE. METHODS: In the HOME-PE trial, hemodynamically stable patients with symptomatic PE were randomized to either triaging with Hestia criteria or sPESI score. We analyzed 3 groups of low-risk PE patients: 47 with active cancer treated at home (group 1), 691 without active cancer treated at home (group 2), and 33 with active cancer as the only sPESI criterion qualifying them for hospitalization (group 3). The main outcome was the composite of recurrent venous thromboembolism, major bleeding, and all-cause death within 30 days after randomization. RESULTS: Patients treated at home had composite outcome rates of 4.3 % (2/47) for those with cancer vs. 1.0 % (7/691) for those without (odds ratio (OR) 4.98, 95%CI 1.15-21.49). Patients with cancer had rates of complications of 4.3 % when treated at home vs. 3.0 % (1/33) when hospitalized (OR 1.19, 95%CI 0.15-9.47). In multivariable analysis, active cancer was associated with an increased risk of complications for patients treated at home (OR 7.95; 95%CI 1.48-42.82). For patients with active cancer, home treatment was not associated with the primary outcome (OR 1.19, 95%CI 0.15-9.74). CONCLUSIONS: Among patients treated at home, active cancer was a risk factor for complications, but among patients with active cancer, home treatment was not associated with adverse outcomes.

Cancer-Associated Thrombosis on Bevacizumab: Risk of Recurrence and Bleeding When Bevacizumab Is Stopped or Continued.

Cancer-associated thrombosis (CAT) is a common complication during cancer, with complex management due to an increased risk of both recurrence and bleeding. Bevacizumab is an effective anti-angiogenic treatment but increases the risk of bleeding and potentially the risk of venous thromboembolism (VTE). The aim of this study was to evaluate the efficacy and safety of anticoagulant therapy in patients with CAT receiving bevacizumab, according to the continuation or discontinuation of bevacizumab. In a retrospective multicenter study, patients receiving anticoagulant for CAT occurring under bevacizumab therapy were included. The primary endpoint combined recurrent VTE and/or major or clinically relevant non-major bleeding. Among the 162 patients included, bevacizumab was discontinued in 70 (43.2%) patients and continued in 92 (56.8%) patients. After a median follow-up of 318 days, 21 (30.0%) patients in the discontinuation group experienced VTE recurrence or major or clinically relevant non-major bleeding, compared to 27 (29.3%) in the continuation group. The analysis of survival following the first event showed no significant difference between the groups in uni- or multivariate analysis (p = 0.19). The primary endpoint was not influenced by the duration of bevacizumab exposure. These results suggest that the efficacy and safety of anticoagulant therapy in patients with CAT receiving bevacizumab is not modified regardless of whether bevacizumab is continued or discontinued.

Selective Arterial Embolization of Pseudoaneurysms and Arteriovenous Fistulas after Partial Nephrectomy: Safety, Efficacy, and Mid-Term Outcomes.

The primary objective was to evaluate the clinical success rate after endovascular embolization of iatrogenic vascular lesions caused during partial nephrectomy. The secondary objective was to evaluate the technical success and to assess potential effects on renal function. We retrospectively included consecutive patients from our center who underwent selective embolization to treat iatrogenic renal arterial lesions induced during partial nephrectomy between June 2010 and June 2020. The technical and clinical success rates and renal outcomes were collected. We identified 25 patients with 47 pseudoaneurysms and nine arteriovenous fistulas. Among them, eight were treated by coils only, eight by liquid embolization agents only, and nine by both. The technical success rate was 96% after the first attempt and 100% after the second attempt. The median follow-up was 27.1 ± 24.3 months. Clinical success, defined as no need for further hemostatic surgery during follow-up, was also obtained in 96% and 100% of patients with one and two attempts, respectively. Renal function estimated by the modification of diet in renal disease equation did not change significantly despite a mean 13.8% ± 15.1% decrease in kidney functional volume estimated by angiography. No complications were attributable to the endovascular treatment. No significant difference was found across embolization agents; however, the subgroup sizes were small. Endovascular embolization is safe and effective for treating iatrogenic arterial lesions after partial nephrectomy: success rates are high, complications are infrequent, and renal function is maintained. Recommendations by interventional radiology societies are needed to standardize this treatment.

X-ray Microtomography to Assess Determinants of In Vivo N-Butyl Cyanoacrylate Glubran®2 Polymerization: A Rabbit-Model Study.

Although introduced decades ago, few cyanoacrylate glues have been approved for endovascular use, despite evidence of their usefulness, notably for complex procedures suchas hemostatic embolization. Indications include massive bleeding requiring emergent hemostasis and prevention of severe bleeding during scheduled surgery to remove a hypervascular tumor. Adding radiopaque Lipiodol Ultra Fluid® (LUF) modulates glue polymerization and allows fluoroscopic guidance, but few comparative in vivo studies have assessed the impact of the resulting change in glue concentration or of other factors such as target-vessel blood flow. In a rabbit model, we used ex vivo X-ray microtomography to assess the results of in vivo renal-artery embolization by various mixtures of N-butyl cyanoacrylate (NBCA), metacryloxysulfolane, and LUF. Overall, penetration to the superficial interlobular arteries was achieved in about two-thirds of cases and into the capillaries in nearly half the cases, while cast fragmentation was seen in slightly more than half the cases. Greater NBCA dilution and the blocked-blood-flow technique were independently associated with greater distality of penetration. Blocked-blood-flow injection was independently associated with absence of fragmentation, capillary penetration, a shorter cast-to-capsule distance, and higher cast attenuation. A larger mixture volume was independently associated with higher indexed cast ratio and deeper penetration. Finally, microtomography is an adapted tool to assess ex vivo distribution of glue cast.

Failure of the Ottawa Score to Predict the Risk of Recurrent Venous Thromboembolism in Cancer Patients: The Prospective PREDICARE Cohort Study.

INTRODUCTION: Recurrent venous thromboembolism (VTE) despite curative anticoagulation is frequent in patients with cancer. Identifying patients with a high risk of recurrence could have therapeutic implications. A prospective study was designed to validate the Ottawa risk score of recurrent VTE in cancer patients. METHODS: In a prospective multicenter observational cohort, adult cancer patients with a recent diagnosis of symptomatic or incidental lower limb deep vein thrombosis or pulmonary embolism (PE) were treated with tinzaparin for 6 months. The primary endpoint was the recurrence of symptomatic or asymptomatic VTE within the first 6 months of treatment. All clinical events were centrally reviewed and adjudicated. Time-to-event outcomes were estimated by the Kalbfleisch and Prentice method to take into account the competing risk of death. A C-statistic value of > 0.70 was needed to validate the Ottawa score. RESULTS: A total of 409 patients were included and analyzed on an intention-to-treat basis. Median age was 68 years, 60.4% of patients had PE, and VTE was symptomatic in 271 patients (66.3%). The main primary sites were lung (31.3%), lower digestive tract (14.4%), and breast (13.9%) cancers. The Ottawa score was high (≥ 1) in 58% of patients. The 6-month cumulative incidence of recurrent VTE was 7.3% (95% confidence interval [CI]: 4.9-11.1) overall, and 5.0% (95% CI: 2.3-10.8) versus 9.1% (95%CI: 6.1-13.6) in the Ottawa low versus high risk groups, respectively. The C-statistic value was 0.60 (95% CI: 0.55-0.65). CONCLUSION: In this prospective cohort of patients with cancer receiving tinzaparin for VTE, the Ottawa score failed to accurately predict recurrent VTE.

Rivaroxaban vs Dalteparin in Cancer-Associated Thromboembolism: A Randomized Trial.

BACKGROUND: Direct oral anticoagulants (DOACs) are an alternative to low-molecular-weight heparin for treating cancer-associated VTE. RESEARCH QUESTION: Is rivaroxaban as efficient and safe as dalteparin to treat patients with cancer-associated VTE? STUDY DESIGN AND METHODS: In a randomized open-label noninferiority trial, patients with active cancer who had proximal DVT, pulmonary embolism (PE), or both were assigned randomly to therapeutic doses of rivaroxaban or dalteparin for 3 months. The primary outcome was the cumulative incidence of recurrent VTE, a composite of symptomatic or incidental DVT or PE, and worsening of pulmonary vascular or venous obstruction at 3 months. RESULTS: Of 158 randomized patients, 74 and 84 patients were assigned to receive rivaroxaban and dalteparin, respectively. Mean age was 69.4 years, and 115 patients (76.2%) had metastatic disease. The primary outcome occurred in 4 and 6 patients in the rivaroxaban and dalteparin groups, respectively (both the intention-to-treat and per-protocol populations: cumulative incidence, 6.4% vs 10.1%; subdistribution hazard ratio [SHR], 0.75; 95% CI, 0.21-2.66). Major bleeding occurred in 1 and 3 patients in the rivaroxaban and dalteparin groups, respectively (cumulative incidence, 1.4% vs 3.7%; SHR, 0.36; 95% CI, 0.04-3.43). Major or clinically relevant nonmajor bleeding occurred in 9 and 8 patients in the rivaroxaban and dalteparin groups, respectively (cumulative incidence, 12.2% vs 9.8%; SHR, 1.27; 95% CI, 0.49-3.26). Overall, 19 patients (25.7%) and 20 patients (23.8%) died in the rivaroxaban and dalteparin groups, respectively (hazard ratio, 1.05; 95% CI, 0.56-1.97). INTERPRETATION: In this trial comparing rivaroxaban and dalteparin in the treatment of cancer-associated VTE, the number of patients was insufficient to reach the predefined criteria for noninferiority, but efficacy and safety results were consistent with those previously reported with DOACs. An updated meta-analysis of randomized trials comparing DOACs with low-molecular-weight heparin in patients with cancer-associated VTE is provided. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT02746185; URL: www. CLINICALTRIALS: gov.

Selective Arterial Embolization with N-Butyl Cyanoacrylate Prior to CT-Guided Percutaneous Cryoablation of Kidney Malignancies: A Single-Center Experience.

The study's purpose was to assess the safety, feasibility and efficiency of selective arterial embolization (SAE) using N-butyl cyanoacrylate (NBCA) glue before percutaneous cryoablation (PCA) of renal malignancies in patients whose tumor characteristics and/or comorbidities resulted in an unacceptable risk of bleeding. In this single-center retrospective study of 19 consecutive high-risk patients (median age, 74 years) with renal malignancies managed in 2017-2020 by SAE with NBCA followed by PCA, data about patients, tumor and procedures characteristics, complications, renal function and hemoglobin concentration before and after treatment, as well as recurrence were collected. Charlson comorbidity index was ≥4 in 89.5% of patients. Ten patients were treated by antiplatelet and/or anticoagulant therapy. Median tumor largest diameter was 3.75 cm (range, 1-6.5 cm) and R.E.N.A.L. nephrometry score was ≥7 in 80%, indicating substantial tumor complexity. No major complications were recorded and minor complications occurred in 7 patients. No residual tumor was found at 6-week imaging follow-up in 18/19 patients. Tumor recurrence was visible in 1/16 patients at 6-month imaging follow-up. No significant difference was found for renal function after treatment (p = 0.07), whereas significant decrease in hemoglobin concentration was noted (p = 0.00004), although it was relevant for only one patient who required only blood transfusion and no further intervention. SAE prior to PCA is safe and effective for managing renal malignancies in high-risk patients.

Selective Arterial Embolization of Renal Angiomyolipomas with a N-Butyl Cyanoacrylate-Lipiodol Mixture: Efficacy, Safety, Short- and Mid-Term Outcomes.

Selective arterial embolization (SAE) for renal angiomyolipoma (rAML) is effective to treat or prevent bleeding. We report our experience using a cyanoacrylate-Lipiodol mixture. We performed a single-center retrospective review of all rAMLs embolized with cyanoacrylate glue between July 2014 and June 2020. Demographics, tuberous sclerosis complex (TSC) status, clinical presentation, angiography features, and follow-up data were recorded. Pre- and post-procedure rAML sizes and volumes were estimated from computed tomography (CT) or magnetic resonance imaging (MRI) studies. Kidney function was assessed before and after the procedure. We identified 24 patients (22 females and 2 males, mean age 51 years) treated for 27 AMLs, either prophylactically (n = 20) or as an emergency (n = 4). Technical success was achieved for 25/27 AMLs; two patients, each with a single AML, required nephrectomy and repeated embolization, respectively. Major complications occurred in three patients and minor complications such as postembolization syndrome in 15 patients. AML volume reduction after embolization was 55.1% after a mean follow-up of 15 months (range, 1-72 months). Factors associated with greater volume reduction were a smaller percentage of fat (p = 0.001), larger initial rAML volume (p = 0.014), and longer follow-up (p = 0.0001). The mean creatinine level did not change after SAE. Embolization of rAMLs with a mixture of cyanoacrylate and Lipiodol is feasible, safe, and effective in significantly decreasing tumor volume.

Available Bleeding Scoring Systems Poorly Predict Major Bleeding in the Acute Phase of Pulmonary Embolism.

We aimed to compare six available bleeding scores, in a real-life cohort, for prediction of major bleeding in the early phase of pulmonary embolism (PE). We recorded in-hospital characteristics of 2754 PE patients in a prospective observational multicenter cohort contributing 18,028 person-days follow-up. The VTE-BLEED (Venous Thrombo-Embolism Bleed), RIETE (Registro informatizado de la enfermedad tromboembólica en España; Computerized Registry of Patients with Venous Thromboembolism), ORBIT (Outcomes Registry for Better Informed Treatment), HEMORR2HAGES (Hepatic or Renal Disease, Ethanol Abuse, Malignancy, Older Age, Reduced Platelet Count or Function, Re-Bleeding, Hypertension, Anemia, Genetic Factors, Excessive Fall Risk and Stroke), ATRIA (Anticoagulation and Risk Factors in Atrial Fibrillation), and HAS-BLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio, Elderly, Drugs/Alcohol) scores were assessed at baseline. International Society on Thrombosis and Haemostasis (ISTH)-defined bleeding events were independently adjudicated. Accuracy of the overall original 3-level and newly defined optimal 2-level outcome of the scores were evaluated and compared. We observed 82 first early major bleedings (3.0% (95% CI, 2.4-3.7)). The predictive power of bleeding scores was poor (Harrel's C-index from 0.57 to 0.69). The RIETE score had numerically higher model fit and discrimination capacity but without reaching statistical significance versus the ORBIT, HEMORR2HAGES, and ATRIA scores. The VTE-BLEED and HAS-BLED scores had significantly lower C-index, integrated discrimination improvement, and net reclassification improvement compared to the others. The rate of observed early major bleeding in score-defined low-risk patients was high, between 15% and 34%. Current available scoring systems have insufficient accuracy to predict early major bleeding in patients with acute PE. The development of acute-PE-specific risk scores is needed to optimally target bleeding prevention strategies.

Clinical characteristics and outcomes of incidental venous thromboembolism in cancer patients: Insights from the Caravaggio study.

BACKGROUND: Clinical guidelines advise similar anticoagulant treatment for symptomatic and incidental cancer-associated venous thromboembolism (VTE). We investigated clinical features and outcomes of cancer patients with incidental or symptomatic VTE randomized in the Caravaggio study. OBJECTIVES: We performed a predefined sub-analysis of the Caravaggio study in order to investigate the clinical features and outcomes of incidental and symptomatic VTE in patients with cancer. The relative efficacy and safety of apixaban and dalteparin in patients with incidental and symptomatic VTE was also assessed. METHODS: The Caravaggio study compared apixaban to dalteparin for the 6-month treatment of cancer-associated VTE. The primary efficacy and safety outcomes were recurrent VTE and major bleeding. RESULTS: Two hundred thirty patients (20%) had incidental and 925 (80%) symptomatic VTE. Pulmonary embolism with or without deep vein thrombosis as index event, colorectal cancer, Eastern Cooperative Oncology Group (ECOG) score of 0, and locally advanced or metastatic cancer were more frequent in patients with incidental VTE. Deep vein thrombosis as index event, hematological cancer, and ECOG score of 2 were more frequent in patients with symptomatic VTE. Ten patients (4.3%) with incidental and 68 (7.4%) with symptomatic VTE had recurrent VTE (hazard ratio [HR] 0.57, 95% confidence interval [CI] 0.29-1.10). Major bleeding occurred in 12 (5.2%) patients with incidental VTE and in 33 (3.6%) patients with symptomatic VTE (HR 1.43, 95% CI 0.74-2.77). When comparing apixaban to dalteparin in patients with symptomatic and incidental VTE, the HR for recurrence was 0.73 (95% CI 0.45-1.19) and 0.41 (95% CI 0.11-1.56), respectively, and the HR for major bleeding 0.93 (95% CI 0.47-1.83) and 0.96 (95% CI 0.31-2.96), respectively. CONCLUSIONS: Compared to cancer patients with symptomatic VTE, those with incidental VTE have different clinical features at presentation, with a numerically lower incidence of recurrent VTE and a numerically higher incidence of major bleeding.

An Original Risk Score to Predict Early Major Bleeding in Acute Pulmonary Embolism: The Syncope, Anemia, Renal Dysfunction (PE-SARD) Bleeding Score.

BACKGROUND: Improved prediction of the risk of early major bleeding in pulmonary embolism (PE) is needed to optimize acute management. RESEARCH QUESTION: Does a simple scoring system predict early major bleeding in acute PE patients, identifying patients with either high or low probability of early major bleeding? STUDY DESIGN AND METHODS: From a multicenter prospective registry including 2,754 patients, we performed post hoc multivariable logistic regression analysis to build a risk score to predict early (up to hospital discharge) major bleeding events. We validated the endpoint model internally, using bootstrapping in the derivation dataset by sampling with replacement for 500 iterations. Performances of this novel score were compared with that of the VTE-BLEED (Venous Thrombo-Embolism Bleed), RIETE (Registro informatizado de la enfermedad tromboembólica en España; Computerized Registry of Patients with Venous Thromboembolism), and BACS (Bleeding, Age, Cancer, and Syncope) models. RESULTS: Multivariable regression identified three predictors for the occurrence of 82 major bleeds (3.0%; 95% CI, 2.39%-3.72%): Syncope (+1.5); Anemia, defined as hemoglobin <12 g/dL (+2.5); and Renal Dysfunction, defined as glomerular filtration rate <60 mL/min (+1 point) (SARD). The PE-SARD bleeding score was calculated by summing all the components. Overall, 52.2% (95% CI, 50.29%-54.11%) of patients were classified as low bleeding-risk (score, 0 point), 35.2% (95% CI, 33.39%-37.04%) intermediate-risk (score, 1-2.5 points), and 12.6% (95% CI, 9.30%-16.56%) high-risk (score >2.5 points). Observed bleeding rates increased with increasing risk group, from 0.97% (95% CI, 0.53%-1.62%) in the low-risk to 8.93% (95% CI, 6.15%-12.44%) in the high-risk group. C-index was 0.74 (95% CI, 0.73-0.76) and Brier score 0.028 in the derivation cohort. Similar values were calculated from internal bootstrapping. Performance of the PE-SARD score was better than that observed with the VTE-BLEED, RIETE, and BACS scores, leading to a high proportion of bleeding-risk reclassification in patients who bled and those who did not. INTERPRETATION: The PE-SARD bleeding risk score is an original, user-friendly score to estimate risk of early major bleeding in patients with acute PE.

Efficacy, safety and outcomes of transcatheter arterial embolization with N-butyl cyanoacrylate glue for non-variceal gastrointestinal bleeding: A systematic review and meta-analysis.

PURPOSE: To perform a systematic review and meta-analysis to determine the safety, efficacy, and outcomes of transcatheter arterial embolization (TAE) with N-butyl cyanoacrylate (NBCA) as the single embolic agent for the management of non-variceal upper and lower gastrointestinal bleeding (GIB). MATERIALS AND METHODS: A literature search using MEDLINE/PubMed, EMBASE, and SCOPUS databases was performed for studies published from January 1980 to December 2019. Data from eligible studies were extracted and evaluated by two independent reviewers. Exclusion criteria were sample size <5, article reporting the use of NBCA with other embolic agents, no extractable data, and duplicate reports. Technical success, clinical success, 30-day rebleeding, 30-day overall and major complications, and 30-day mortality were evaluated. The estimated overall rates were calculated with their 95% confidence intervals, based on each study rate, weighted by the number of patients involved in each study. Heterogeneity across studies was assessed using the Q test and I2 statistic. RESULTS: Fifteen studies with 574 patients were included. For upper GIB (331 patients), the technical and clinical success rates, and 30-day rebleeding and mortality rates, were 98.8% (328 of 331 patients) and 88.0% (237 of 300 patients), and 12.5% (69 of 314 patients) and 15.9% (68 of 331 patients), respectively. Thirty-day overall and major complications occurred in 14.3% (28 of 331 patients) and 2.7% (7 of 331 patients) of patients, respectively. For lower GIB (243 patients), the technical and clinical success rates, and 30-day rebleeding and mortality rates, were 98.8% (78 of 78 patients) and 78.0% (145 of 189 patients), and 15.7% (33 of 218 patients) and 12.7% (14 of 78 patients), respectively. Thirty-day overall and major complications occurred in 13.0% (25 of 228 patients) and 8.6% (19 of 228 patients) of patients, respectively. CONCLUSION: TAE with NBCA is safe and effective for treating non-variceal GIB, with high clinical success and very low major complication rates.

Percutaneous Implantation of a Microcatheter-Port System for Hepatic Arterial Infusion Chemotherapy of Unresectable Liver Tumors: Technical Feasibility, Functionality, and Complications.

To evaluate the feasibility and safety of percutaneously implanted arterial port catheter systems for hepatic arterial infusion of chemotherapy (HAI) in patients with unresectable liver malignancies. From October 2010 to August 2018, arterial port catheters for HAI were percutaneously implanted in 43 patients with unresectable liver malignancies. Three different catheter placement techniques were compared: a conventional end-hole catheter placed in the common hepatic artery (technique 1, n = 16), a side-hole catheter with the tip fixed in the gastroduodenal artery (technique 2, n = 18), and a long-tapered side-hole catheter with the tip inserted distally in a segmental hepatic artery (technique 3, n = 6). Catheter implantation was successful in 40 (93%) of the 43 patients. Complications related to catheter placement were observed in 10 (23%) patients; 5 (83%) of the 6 major complications were resolved, as well as all 4 minor complications. Catheter migration and occlusion occurred in 9 (22.5%) patients. Catheter migration was more frequent with technique 1 (n = 6) than with technique 2 (n = 1), although the difference was not significant (p = 0.066). Percutaneous arterial port catheter implantation for HAI is highly feasible and carries a low risk of complications.

Portal vein embolization with ethylene-vinyl alcohol copolymer for contralateral lobe hypertrophy before liver resection: safety, feasibility and initial experience.

BACKGROUND: To report our preliminary experience with preoperative portal vein embolization (PVE) using liquid ethylene vinyl alcohol (EVOH) copolymer. METHODS: Retrospectively review of patients with primary or secondary liver malignancies scheduled for extensive hepatectomy after the induction of future liver remnant (FLR) hypertrophy by right or left PVE with EVOH as the only embolic agent between 2014 and 2018 at two academic centers. Cross-sectional imaging liver volumetry data obtained before and 3-6 weeks after PVE were used to assess the FLR volume (FLRV) increase, degree of FLR hypertrophy and the FLR kinetic growth rate (KGR). RESULTS: Twenty-six patients (17 males; mean age, 58.7±11 years; range, 32-79 years) were included. The technical and clinical success rate was 100%. PVE produced adequate FLR hypertrophy in all patients. Embolization occurred in all targeted portal branches and in no non-target vessels. The %FLRV increased by 52.9%±32.5% and the degree of FLR hypertrophy was 16.7%±6.8%. The KGR was 4.4%±2.0% per week. Four patients experience minor complications after PVE which resolved with symptomatic treatment. The resection rate was 84.5%. One patient died during surgery for reasons unrelated to PVE. CONCLUSIONS: Preoperative PVE with EVOH copolymer is feasible, safe, and effective in inducing FLR hypertrophy.

Myocardial infarction during giant cell arteritis: A cohort study.

BACKGROUND: Cardiovascular risk is increased in giant cell arteritis (GCA). We aimed to characterize myocardial infarction (MI) in a GCA cohort, and to compare the GCA and non-GCA population affected by MI. METHODS: In patients with a biopsy-proven diagnosis of GCA between 1 January 2001 and 31 December 2016 in Côte D'Or (France), we identified patients with MI by crossing data from the territorial myocardial infarction registry (Observatoire des Infarctus de Côte d'Or) database. Five controls (non-GCA + MI) were paired with one case (GCA + MI) after matching for age, sex, cardiovascular risk factors and prior cardiovascular disease. MI were characterized as type 1 MI (T1MI), resulting from thrombus formation due to atherothrombotic disease, or type 2 MI (T2MI), due to a myocardial supply/demand mismatch. GCA-related MI was defined as MI occurring within 3 months of a GCA flare (before or after). RESULTS: Among 251 biopsy-proven GCA patients, 13 MI cases were identified and paired with 65 controls. MI was GCA-related in 6/13 cases, accounting for 2.4% (6/251) of our cohort. T2MI was more frequently GCA-related than GCA-unrelated (80% vs. 16.7%, p = 0.080), and GCA diagnosis was the only identified triggering factor in 75% of GCA-related T2MI. GCA-unrelated MI were more frequently T1MI and occurred in patients who had received a higher cumulative dose of prednisone (p = 0.032). GCA was not associated with poorer one-year survival. CONCLUSIONS: GCA-related MI are mainly T2MI probably caused by systemic inflammation rather than coronaritis. GCA-unrelated MI are predominantly T1MI associated with atherothrombotic coronary artery disease.

Renal dysfunction improves risk stratification and may call for a change in the management of intermediate- and high-risk acute pulmonary embolism: results from a multicenter cohort study with external validation.

BACKGROUND: Renal dysfunction influences outcomes after pulmonary embolism (PE). We aimed to determine the incremental value of adding renal dysfunction, defined by estimated glomerular filtration rate (eGFR), on top of the European Society of Cardiology (ESC) prognostic model, for the prediction of 30-day mortality in acute PE patients, which in turn could lead to the optimization of acute PE management. METHODS: We performed a multicenter, non-interventional retrospective post hoc analysis based on a prospectively collected cohort including consecutive confirmed acute PE stratified per ESC guidelines. We first identified which of three eGFR formulae most accurately predicted death. Changes in global model fit, discrimination, calibration and reclassification parameters were evaluated with the addition of eGFR to the prognostic model. RESULTS: Among 1943 patients (mean age 67.3 (17.1), 50.4% women), 107 (5.5%) had died at 30 days. The 4-variable Modification of Diet in Renal Disease (eGFRMDRD4) formula predicted death most accurately. In total, 477 patients (24.5%) had eGFRMDRD4 < 60 ml/min. Observed mortality was higher for intermediate-low-risk and high-risk PE in patients with versus without renal dysfunction. The addition of eGFRMDRD4 information improved model fit, discriminatory capacity, and calibration of the ESC model. Reclassification parameters were significantly increased, yielding 18% reclassification of predicted mortality (p < 0.001). Predicted mortality reclassifications across risk categories were as follows: 63.1% from intermediate-low risk to eGFR-defined intermediate-high risk, 15.8% from intermediate-high risk to eGFR-defined intermediate-low risk, and 21.0% from intermediate-high risk to eGFR-defined high risk. External validation in a cohort of 14,234 eligible patients from the RIETE registry confirmed our findings with a significant improvement of Harrell's C index and reclassification parameters. CONCLUSION: The addition of eGFRMDRD4-derived renal dysfunction on top of the prognostic algorithm led to risk reclassification within the intermediate- and high-risk PE categories. The impact of risk stratification integrating renal dysfunction on therapeutic management for acute PE requires further studies.

Packing Technique with or without Remodeling for Endovascular Coil Embolization of Renal Artery Aneurysms: Safety, Efficacy and Mid-Term Outcomes.

The endovascular treatment of renal artery aneurysms (RAAs) has lower morbidity and shorter stay lengths compared to surgical repair. Here, we describe coil packing with or without remodeling and assess outcomes and complications. We retrospectively identified the 19 consecutive preventive endovascular RAA coil embolizations done in 18 patients at our center in 2010-2020. Patient and aneurysm characteristics, technical success rate, complications, and recurrences were recorded. Mean patient age was 63 ± 13 years. The RAA was >1.5 cm in 11 cases, and in four cases, the aneurysm-to-parent artery size ratio was >2. Simple coiling was performed for 11 (57.9%) aneurysms, stent-assisted coiling for seven (36.8%) aneurysms, and balloon-assisted coiling for one (5.3%) aneurysm. Technical success rate was 100%. Complete definitive RAA exclusion was achieved with a single procedure for 17 (89.5%) aneurysms, whereas two (10.5%) aneurysms required a repeat procedure. Four minor complications occurred but resolved with no long-term consequences. No major complications occurred during the mean follow-up of 41.1 ± 29.7 months. Coil embolization by sac packing or remodeling proved very safe and effective. Together with the known lower morbidity and shorter stay length compared to open surgery, these data indicate that this endovascular procedure should become the preventive treatment of choice for RAAs.

Reasons Influencing Long-Term Anticoagulant Treatment Beyond 6 Months for Cancer-Associated Thrombosis in USCAT, A 432-Patient Retrospective Non-Interventional Study.

Background and objectives: Few data are available about anticoagulation management beyond 6 months in patients with cancer associated thrombosis (CAT). Our objective was to describe anticoagulant treatment modalities up to 12 months. Methods: The management of the anticoagulant treatment beyond 6 months was described in this initially retrospective non-interventional French multicenter study in patients treated with low-molecular-weight heparins (LMWH) still alive at the end of an initial 6-month treatment period. Clinical outcomes, including venous thromboembolism, recurrence, bleeding and deaths have been published previously. Results: Among the 432 patients (mean age 66.5±12.7 years) included in the study, 332 were followed up to 12 months while 96 patients deceased before study end and 4 patients were lost-to-follow-up. At 6 months, anticoagulant therapy was stopped in 74 patients, 56 were switched to vitamin K antagonists (VKA) (16.1% [95%CI, 12.4%-20.4]), 30 to direct oral anticoagulants (DOAC) (8.6% [95%CI, 5.9%-12.1]). LMWHs were maintained in 256 patients (73.6% [95%CI, 68.6-78.1]). During the follow-up, LMWHs were definitively discontinued in 86 patients (33.7%), the main reason being a favorable course of the cancer (16 patients, 18.6%), or the thromboembolic disease (11 patients, 12.8%), whereas concern about bleeding risk was low (2 patients, 2.3%). Conclusion: Anticoagulation beyond 6 months and up to 12 months was in accordance with clinical practice guidelines suggesting that treatment should be continued as long cancer is active or in the absence of bleeding risk. Anticoagulant treatment discontinuation beyond 6 months was influenced by the favorable courses of both malignancy and thromboembolic disease, as well as patient's preference.

Percutaneous Rotational Mechanical Atherectomy Plus Thrombectomy Using Rotarex S Device in Patients With Acute and Subacute Lower Limb Ischemia: A Review of Safety, Efficacy, and Outcomes.

Acute and subacute ischemia of lower limbs is associated with high risk of amputation and potential severe life-threatening complications. Despite a lack of clear therapeutic recommendations, surgical treatments such as thrombectomy or bypass and/or catheter-directed thrombolysis (CDT) have been first-line procedures in both acute and subacute limb ischemia, but each therapy may lead to significant morbidity and mortality. Such situations demand fast restoration of appropriate flow to preclude limb loss and other complications. Percutaneous mechanical atherectomy plus thrombectomy (MATH) represents a minimally invasive approach for quickly recanalizing thrombus-containing lesions whatever the age of thrombus. Indeed, many chronic patients can present with critical limb ischemia, with thrombus-containing occlusive lesions triggered by underlying atherosclerotic disease. MATH offers various advantages over surgery and CDT, with lower invasiveness, faster recanalization, and the possibility to immediately treat the underlying lesions, with a lower rate of bleeding complications and no need for intensive care unit stay. Currently, several mechanical thrombectomy devices are offered as an alternative therapy and can be divided into pure rotational MATH systems and rheolytic thrombectomy devices. The only pure rotational MATH device currently available on the market is the Rotarex S device. We aimed to review contemporary clinical data regarding the safety, efficacy, and outcomes of MATH therapy using Rotarex S catheter in acute and subacute thrombus-containing arterial lesions of lower limbs. Future perspectives of Rotarex S MATH treatment and cost-effectiveness of its routine use will be also discussed.

Long-Term Treatment of Cancer-Associated Thrombosis (CAT) Beyond 6 Months in the Medical Practice: USCAT, a 432-Patient Retrospective Non-Interventional Study.

BACKGROUND: extended anticoagulant therapy beyond the initial 6 months is suggested in patients with cancer-associated thrombosis (CAT) and active cancer. Few data are available on patient management and outcomes on the period between 6 and 12 months after the venous thromboembolism (VTE) event. OBJECTIVES: our objective was to document patient management and outcomes beyond 6 months and up to 12 months in CAT patients initially treated for 6 months with tinzaparin. METHODS: adult CAT patients with a cancer still alive at the end of an initial 6-month treatment period were eligible to participate in this retrospective non-interventional French multicenter study. RESULTS: a total of 432 patients aged 66.5 ± 12.7 years were available to participate in this study. Out of the patients included in the study, the anticoagulant treatment was maintained in 348 of 422 documented patients (82.5%) while it was discontinued in 74 (17.5%) patients (before the end or at the end of the initial 6-month treatment period). Between 6 and 12 months, 24 patients (5.7%) experienced VTE recurrence, while 21 (5.1%) patients had clinically relevant bleeding, 11 patients (2.7%) had major bleeding and 96 patients (22.3%) died, mostly from cancer. VTE recurrence was more frequent in patients with lung (14.3%) and colorectal cancer (6.0%) while major bleeding was more frequent in patients with colorectal cancer (6.0%). CONCLUSION: clinical outcomes were consistent with previous observations and variable according to the type of cancer. Further clinical research is required to orient the management of patients with CAT beyond 6 months based on cancer-specific treatment strategies.