Percutaneous transluminal angioplasty of femoropopliteal veins for treatment of post-thrombotic syndrome.

Background: Controversy persists concerning the endovascular treatment of the post-thrombotic syndrome (PTS), particularly if femoropopliteal veins are involved. Methods: We screened consecutive patients with PTS who underwent percutaneous transluminal angioplasty (PTA) of femoropopliteal veins using posterior tibial or popliteal vein access who had at least 3-month follow-up. Our assessment included the evaluation of primary and secondary patency of the treated segments by Doppler ultrasound (DUS) and clinical outcomes measured by the change in Villalta score as well as ulcer healing. Results: Among 29 patients, 8 (27.7%) were women and the mean (SD) age was 53.3 (13.6) years. Posterior tibial vein and popliteal access were used in 26 (89.7%) and 3 patients (10.3%), respectively. 13 (44.8%) patients had prior (n = 11, 37.9%) or concomitant (n = 9, 31.0%) endovascular treatment of the iliac or common femoral veins. At a median follow-up of 395 days (Q1: 205-Q3: 756 days), primary patency of femoropopliteal veins was 79.3% (95% CI 64.6-94.1%) and secondary patency was 82.8% (95% CI, 69.0-96.5%). The percentage of patients with moderate or severe PTS according to the Villalta score decreased from baseline to last follow-up from 34.5% to 18.5% and from 31% to 14.8%, respectively (p<0.003). Overall, the mean (SD) Villalta score decreased from 11.5 (1.7) to 8.0 (1.7) (p<0.0001). Postprocedural complete ulcer healing occurred in 4 out of 5 (80%) patients. Two (6.9%) patients developed new ulcers. No major bleeding, pulmonary embolism, stroke, or death occurred. Conclusion: PTA of femoropopliteal veins via posterior tibial or popliteal vein access appears to improve the severity of PTS with acceptable patency rates.

Mortality rate related to peripheral arterial disease: A retrospective analysis of epidemiological data (years 2008-2019).

BACKGROUND AND AIMS: Peripheral arterial disease (PAD) is one of the most prevalent cardiovascular diseases with more than 230 million people being affected worldwide. As highlighted by the recent European Society of Cardiology guidelines, data on the epidemiology of PAD is urgently needed. METHODS AND RESULTS: We accessed the vital registration data of the Veneto region (Northern Italy, approximately five millions inhabitants) covering the period 2008-2019. We computed annual age-standardized rates for PAD reported as the underlying cause of death (UCOD) or as one of multiple causes of death (MCOD). Age-adjusted odds ratios (OR) served to study the association between PAD and cardiovascular comorbidities. The age-standardized mortality rate for PAD as MCOD slightly declined from 19.6 to 17.8 in men and from 10.8 to 9.1 deaths per 100,000 population-years in women. The age-standardized PAD-specific mortality rate (UCOD) remained stable: 3.1 to 3.7 per 100,000 person-years in women (Average Annual Percent Change 1.3, 95% CI -0.8; 3.4%) and 4.4 to 4.3 per 100,000 person-years (Average Annual Percent Change -0.2, 95% CI -3.6; 3.4%) in men. PAD contributed to 1.6% of all deaths recorded in the region. Ischemic heart disease, diabetes mellitus and neoplasms were the most prevalent UCOD among PAD patients. PAD was associated with diabetes mellitus (OR 3.79, 95%CI 3.55-4.06) and chronic kidney diseases (OR 2.73, 95%CI 2.51-2.97) in men, and with atrial fibrillation (OR 2.26, 95%CI 2.10-2.44) in women. CONCLUSION: PAD remains a substantial cause of death in the general population of this high-income region of Western Europe with marked sex-specific differences.

Common laboratory tests and their correlation with the clinical presentation and prognosis of Lemierre syndrome.

INTRODUCTION: Lemierre syndrome is a thromboembolic complication following an acute bacterial infection of the head/neck area, often due to anaerobes. Data on the prognostic role of laboratory parameters is lacking. METHODS: We analyzed individual-patient level data from a multinational cohort of patients with Lemierre-syndrome. Patients had an infection in the head/neck area, and contiguous vein thrombosis or septic embolism, irrespective of the causal pathogen. We studied the patterns of white blood cell count, platelet count, and C-reactive protein concentration investigating their association with baseline characteristics and in-hospital clinical outcomes (septic embolism, major bleeding, all-cause death). RESULTS: A total of 447 (63%) patients had complete data for analysis. White blood cells were elevated across all subgroups (median 17 × 103/µL; Q1-Q3:12-21). Median platelet count was 61 × 103/µL (Q1-Q3:30-108) with decreasing levels with increasing age. Males, patients with renal failure or cardiopulmonary impairment, and those with typical Lemierre syndrome (tonsillitis, septic thromboembolism, positivity for Fusobacterium spp.) had the lowest platelet count. Median C-reactive protein was 122 (Q1-Q3:27-248) mg/L with higher values in patients who also had more severe thrombocytopenia. The overall risk of complications was similar across subgroups of patients stratified according to white blood cell and C-reactive protein levels. Patients in the lowest third of platelet count (<42 × 103/µL) had the highest rate of complications (26%), as opposed to those in the highest third (11%), notably septic embolic events. CONCLUSIONS: Common laboratory tests correlate with the clinical presentation of Lemierre syndrome. However, extreme values did not appear to be prognostically relevant for in-hospital complications and potentially able to improve clinical management.

Clinical outcomes of a balloon-expandable stent for symptomatic obstructions of the subclavian or innominate arteries.

Background: Upper-extremity peripheral arterial disease (PAD) may present with a broad spectrum of signs and symptoms. If an endovascular treatment is planned, percutaneous angioplasty and stent placement may lead to a better patency compared to percutaneous angioplasty alone. We assessed the characteristics and clinical course of patients with upper-extremity PAD who received angioplasty and a balloon-expandable stent. Patients and methods: We analyzed data from consecutive patients treated with angioplasty and placement of a balloon-expandable BeSmooth Peripheral Stent System® (Bentley, Germany) at the Angiology Department (University Hospital Zurich) between 2018 and 2022. The primary outcome was re-intervention at the target lesion within 6 months from index angioplasty and during available follow-up. The study was approved by the local ethical commission. Results: A total of 27 patients were treated. The median age was 70 (Q1-Q3: 60-74) years and 59% were men. The subclavian artery (74%) represented the most frequently treated target lesion, followed by the innominate artery (26%). The mean improvement in blood pressure in the treated arm was 21 (95%CI 7 to 35) mmHg at 24 hours and 29 (95%CI 15 to 43) mmHg at 6 months. At 6 months, 2 (8%) patients required a target lesion re-intervention. During the remaining follow-up period up to 24 months, one of these two patients required additional intervention and a total of 3 (11%) patients died due to sepsis, cancer, and unknown causes, respectively. Conclusions: Percutaneous catheter-based treatment with a balloon-expandable stent for symptomatic upper extremity PAD appeared to be effective and safe.

Coagulation-monitored, dose-adjusted catheter-directed thrombolysis or pharmaco-mechanical thrombus removal in deep vein thrombosis.

Background: Pharmaco-mechanical thrombectomy (PMT) and catheter-directed thrombolysis (CDT) are therapeutic options for selected patients with acute deep vein thrombosis (DVT) to prevent post-thrombotic syndrome (PTS). Patients and methods: We aimed to describe the clinical characteristics and outcomes of 159 patients with symptomatic iliofemoral DVT undergoing PMT alone, CDT alone, or CDT followed by PMT (bail-out) in the Swiss Venous Stent Registry. The primary outcome was the incidence of peri-interventional major and minor bleeding complications (ISTH criteria). Secondary outcomes included the incidence of PTS and stent patency after 3 years. Results: Mean age was 49±20 years and 58% were women. DVT involved the iliac veins in 99% of patients, whereas 53% had an underlying iliac vein compression. PMT alone was used in 40 patients, CDT alone in 77, and 42 received initial CDT followed by bail-out PMT due to insufficient thrombus clearance. Single-session PMT was the preferred approach in patients with iliac vein compression, patent popliteal vein, and absence of IVC thrombus. Patients treated with PMT alone received a lower r-tPA dose (median 10 mg, IQR 10-10) vs. those treated with CDT (20 mg, IQR 10-30). The rate of peri-interventional major bleeding was 0%, 1%, and 2%, whereas that of minor bleeding was 0%, 1%, and 12%, respectively, all occurring during CDT. After 3 years, PTS occurred in 6%, 9%, and 7% of patients, respectively. The primary stent patency rate was 95%, 88%, and 83%, respectively. Conclusions: The use of PMT and CDT for iliofemoral DVT was overall safe and resulted in high long-term patency and treatment success. Given the less severe presentation of DVT, single-session PMT appeared to be characterized by numerically better primary patency and lower perioperative bleeding event rates than CDT.

Ultrasound-facilitated, catheter-directed thrombolysis vs anticoagulation alone for acute intermediate-high-risk pulmonary embolism: Rationale and design of the HI-PEITHO study.

BACKGROUND: Due to the bleeding risk of full-dose systemic thrombolysis and the lack of major trials focusing on the clinical benefits of catheter-directed treatment, heparin antiocoagulation remains the standard of care for patients with intermediate-high-risk pulmonary embolism (PE). METHODS AND RESULTS: The Higher-Risk Pulmonary Embolism Thrombolysis (HI-PEITHO) study (ClinicalTrials.gov Identifier: NCT04790370) is a multinational multicenter randomized controlled parallel-group comparison trial. Patients with: (1) confirmed acute PE; (2) evidence of right ventricular (RV) dysfunction on imaging; (3) a positive cardiac troponin test; and (4) clinical criteria indicating an elevated risk of early death or imminent hemodynamic collapse, will be randomized 1:1 to treatment with a standardized protocol of ultrasound-facilitated catheter-directed thrombolysis plus anticoagulation, vs anticoagulation alone. The primary outcome is a composite of PE-related mortality, cardiorespiratory decompensation or collapse, or non-fatal symptomatic and objectively confirmed PE recurrence, within 7 days of randomization. Further assessments cover, apart from bleeding complications, a broad spectrum of functional and patient-reported outcomes including quality of life indicators, functional status and the utilization of health care resources over a 12-month follow-up period. The trial plans to include 406 patients, but the adaptive design permits a sample size increase depending on the results of the predefined interim analysis. As of May 11, 2022, 27 subjects have been enrolled. The trial is funded by Boston Scientific Corporation and through collaborative research agreements with University of Mainz and The PERT Consortium. CONCLUSIONS: Regardless of the outcome, HI-PEITHO will establish the first-line treatment in intermediate-high risk PE patients with imminent hemodynamic collapse. The trial is expected to inform international guidelines and set the standard for evaluation of catheter-directed reperfusion options in the future.

A novel management strategy for treatment of pelvic venous disorders utilizing a clinical screening score and non-invasive imaging.

Background: Treatment of pelvic venous disorders (PVD) including pelvic congestion syndrome (PCS) are often delayed due to its varying clinical manifestations. Patients and methods: Patient referral was based on a literature- and personal experience-derived clinical "PCS screening score" (higher score points indicate greater likelihood with a maximum score of 10 points). We studied consecutive women who were (i) referred for vascular assessment and treatment to the University Hospital Zurich (2017-2021), (ii) had a PCS score ≥3 points, (iii) had evidence of obstructive or non-obstructive PVD by duplex sonography or cross-sectional imaging, and (iv) underwent endovascular therapy. The primary outcome was change in symptom severity after endovascular therapy: (i) freedom from symptoms, (ii) improvement with residual symptoms, (iii) no improvement. Results: We included 43 women (mean age 36 years): 81% had previous pregnancy, 19% endometriosis. The median PCS score was 7 (IQR 5-9) points. Chronic lower-abdominal pain was the leading symptom in 86% patients, followed by recurrent leg (9%) and vulvar (5%) varicosities. The main PVD pathologies were ovarian vein insufficiency (61%), internal iliac vein insufficiency (9%), or a combination of both (30%), whereas 42% had a deep venous obstruction of the inferior vena cava, common iliac or left renal veins. Endovascular therapy included ovarian vein embolization (86%), internal iliac vein embolization (9%), and venous stent placement (35%). After a median of 4 (IQR 1-8) months from endovascular treatment, 40 (93%) patients reported improvement of the leading symptom, and 14 (33%) were symptom-free. Complications included re-intervention for stent stenosis (13%, all post-thrombotic), coil-migration into the left renal vein (7%, all retrieved), and transient pelvic sclerotherapy-induced thrombophlebitis (2%). Conclusions: Endovascular therapy following a diagnostic approach, which included a PCS screening tool and non-invasive imaging, appeared to be highly effective and was associated with a low rate of complications.

Prevalent use of high-intensity statin therapy and LDL-C target attainment among PAD patients undergoing angioplasty.

Background: The global burden of peripheral arterial disease (PAD) is substantial. Reducing the major modifiable risk factors for noncommunicable disease, including dyslipidaemia, represents a public health priority. Aim is to evaluate the prevalent adequate use of lipid-lowering therapy (LLT) and low-density lipoprotein cholesterol (LDL-C) attainment among patients with PAD of the lower extremities undergoing percutaneous transluminal angioplasty. Patients and methods: We screened PAD patients treated at the University Hospital Zurich (January 2012-December 2018). We excluded patients <18 years, without classifiable severity of PAD, or with missing LDL-C or medication data. In this cross-sectional study, we studied the prevalent LLT use and LDL-C values in target according to the most recent European guidelines. Available clinical data included demographic information, lipid profile, type and dose of LLT, characteristics of the artery obstruction and angioplasty. Results: A total of 2,148 angioplasties were performed in 956 patients: 614 (64%) were men; the mean age was 70.6 (SD 11.4) years. A total of 608 (64%) had a non-critical PAD (Fontaine stage I-IIb), whereas the remaining had a critical limb ischemia or a diabetic foot syndrome. Their median LDL-C value was 2.00 (Q1-Q3: 1.50-2.60) mmol/L. In accordance to the 2016 and 2019 European Society of Cardiology guidelines, the LDL-C target of 1.8 and 1.4 mmol/L was not reached in 63% (n=599) and in 79% (n=760) of patients, respectively. Only 41% (n=390) of patients were on high-intensity statin therapy. Conclusions: The attainment of LDL-C targets, as recommended by current European guidelines, and the use of high-intensity LLT were unsatisfactory in the majority of PAD patients.

Impact of concomitant popliteal vein thrombosis in patients with acute iliofemoral deep vein thrombosis treated with endovascular early thrombus removal.

Background: Catheter-based thrombus removal (CBTR) reduces the risk of moderate to severe post-thrombotic syndrome (PTS) in patients with acute iliofemoral deep vein thrombosis (IF-DVT). However, the impact of concomitant popliteal DVT on clinical and duplex sonographic outcomes is unknown. Patients and methods: In this post-hoc analysis including the entire cohort of the randomized controlled BERNUTIFUL trial (48 patients), we compared clinical (incidence/severity of PTS assessed by Villalta score and revised venous clinical severity scores, rVCSS), disease-specific quality-of-life (QOL, CIVIQ-20 survey) and duplex sonographic outcomes (patency, reflux, post-thrombotic lesions) at 12 months follow-up between patients with IF-DVT with and without concomitant popliteal DVT treated by CBTR. Results: Overall, 48 IF-DVT patients were included (48% men, median age of 50 years), of whom 17 (35%) presented with popliteal DVT. At baseline, patients with popliteal DVT were older, had a higher body mass index and more important leg swelling. At 12 months, freedom from PTS (93% vs 87%, P=0.17), median total Villalta score (1 vs 1.5; P=0.46), rVCSS (2 vs 1.5, P=0.5) and disease-specific QOL (24 points vs 24 points, P=0.72) were similar between patient with and without popliteal DVT, respectively. Duplex sonographic outcomes were similar, except for more frequent popliteal post-thrombotic lesions and reflux (P=0.02) in patients with popliteal DVT. Conclusions: Relevant clinical outcomes 1 year after successful CBTR were favorable, regardless of the presence or absence of concomitant popliteal DVT. However, post-thrombotic popliteal vein lesions and reflux are more frequent in IF-DVT patients with popliteal involvement. Their impact on long-term outcomes remains to be investigated.

Transient perivascular inflammation of the carotid artery (TIPIC) syndrome.

Background: The Transient Perivascular Inflammation of the Carotid artery (TIPIC) syndrome is presumably a very rare disease characterized by a local transient inflammation of the tissue around the carotid artery. Its pathophysiology remains unknown. We performed an updated study of TIPIC syndrome cases in the setting of a multinational collaborative study. Methods: This study was conducted as an observational multinational retrospective individual patient level cohort study. Information from all known cases diagnosed with TIPIC syndrome in the literature (2005-2020) was collected after a semi-structured literature search of PubMed and Web of Science. We also collected unpublished information of patients from French, Swiss, and Italian vascular medicine or radiology departments. Results: A total of 72 patients were included and served for data analysis: 42 (58.3%) were women; the mean age was 47.9 (SD=11.4) years. Symptoms were unilateral in 92% of patients and 81.4% required pain killers. At baseline, irrespective of the imaging method used, the median thickness of the carotid lesions was 5 (Q1-Q3: 4-7; range: 2-11) mm and the median length of the lesion was 20 (Q1-Q3: 10-30; range: 3-50) mm. We found a positive linear correlation between thickness and length. At follow-up, the thickness of the carotid lesions decreased to a median of 2 (Q1-Q3: 1-3; range: 0-6) mm; the length decreased to a median 10 (Q1-Q3: 5-15; range: 0-41) mm. A linear correlation between baseline and follow-up values was observed for both thickness and length measurements. Symptoms disappeared after a median of 14 (Q1-Q3: 10-15) days. Thirteen patients experienced a recurrence after a median follow-up of 6 (Q1-Q3: 2-12) months. Conclusions: The present analysis elucidates clinical and sonographic characteristics of TIPIC syndrome, indicating the benign nature of this condition. A future international registry will study the long-term course of the disease.

Clinical presentation and long-term follow-up of 45 patients with Mondor disease: A single-center longitudinal study.

Mondor disease is characterized by an acute painful thrombophlebitis occurring at specific anatomical sites. Data on its incidence, characteristics of clinical presentation, and course are unavailable to date. We studied the course of Mondor disease in patients diagnosed and followed at the University Hospital Zurich (Switzerland) between 2004 and 2020. The primary study outcomes were a diagnosis of active cancer either at the time of clinical diagnosis of Mondor disease or within 1 year, as well as 1-year all-cause death and recurrent Mondor disease. We included 45 patients and classified them into one of the three Mondor disease subgroups: thoracic (n = 26), penile (n = 12), or axillary (n = 7). The median age was 39 (Q1-Q3: 30-45) years and 44% of patients were men. Surgery was the likely cause of Mondor disease in 53.8% of patients with a thoracic form, 41.7% of those with a penile location, and all of those with an axillary location. Known active cancer was present in nine (20%) of 45 patients at baseline. One-year follow-up was available for 43 patients (median 94 months), whereas 6-month data were available for the remaining two patients. During the available follow-up, no patient had a new diagnosis of cancer. In conclusion, one in five patients with Mondor disease had known cancer at the time of diagnosis. During follow-up, the rate of new cancer diagnosis and death was negligible, providing reassurance about the good prognosis of this condition. Based on these preliminary data, extended cancer screening besides what is recommended by current guidelines for the general population might not be necessary in patients with Mondor disease.

Modified cardiopulmonary bypass circuit for the use of the AngioVac® system in a case with high paradoxical embolization risk.

The AngioVac® is a vacuum-assisted percutaneous thrombectomy suction system. In critically ill patients, the sudden volume shift can result in abrupt hemodynamic changes thus leading to a cardiac right-left shunt with a high risk of paradoxical embolization. We describe a modified cardiopulmonary bypass circuit for the use of the AngioVac® system that enables full cardiopulmonary support and reduces paradoxical thromboembolic risk.

Duplex Ultrasound Investigation for the Detection of Obstructed Iliocaval Venous Stents.

OBJECTIVE: Duplex ultrasound (DUS) is used for routine surveillance of stents in iliocaval veins, but direct visualisation is often challenging. Duplex ultrasound criteria for detecting venous stent obstruction (VSO) have not been defined to date. METHODS: A nested case control study of 120 patients (42 ± 17 years, 53% women, mean 2.7 ± 1.8 stents) was performed, and the performance of various duplex parameters for detecting VSO (defined as > 50% lumen diameter reduction or occlusion) was tested, confirmed by biplane venography or intravascular ultrasound (IVUS). Forty patients with VSO (25 with stent occlusion, 15 with >50% in stent stenosis) were matched to 80 control patients by age, gender and index diagnosis who fulfilled the following criteria: (1) ongoing symptom control (Villalta score < 5), (2) good image quality of entire stent segment, (3) spontaneous colour Doppler signal > 50% of lumen in entire stent segment, (4) at least two DUS where the baseline DUS was obtained within 24 h after successful venous intervention. RESULTS: The best test was the combination of peak flow velocity and flow pattern analysis at the stent inlet. A peak flow velocity >10 cm/s and a flow pattern spontaneously modulated by respiration ruled out VSO with a specificity of 93.7% (95% CI 86.0%-97.3%). A peak flow velocity ≤10 cm/s or any Doppler flow pattern other than spontaneously modulated by respiration was 92.1% (95% CI 79.2%-97.3%) sensitive to detect VSO. CONCLUSION: The combination of peak flow velocity and analysis of Doppler flow pattern at the stent inlet is accurate to diagnose or rule out stent occlusion. Indirect criteria should always be combined with direct visualisation of iliocaval stents since those may be less sensitive for detecting stent stenosis.

Prevalence of carotid plaque stenosis after head and neck radiotherapy - an observational study of 156 survivors.

Background: Radiotherapy for head and neck cancer (HNC) represents a well-known predisposing factor for asymptomatic carotid artery lesions and acute cerebrovascular accidents. Our aim is to provide contemporary estimates on the prevalence, severity, and characteristics of carotid artery lesions in HNC survivors. Patients and methods: We prospectively included HNC patients who underwent radiotherapy and were free from the disease at the time of duplex ultrasound evaluation. Patients were re-contacted telephonically and those who agreed to participate were invited for an ambulatory visit when the investigators collected clinical information and performed duplex ultrasound examination based on a predefined protocol. Results: A total of 156 patients were included and underwent duplex ultrasound examination after a mean of 65.2 months from the last session of radiotherapy. A total of 36 patients (23.1%) had normal carotid arteries; mild, non-stenotic lesions were observed in 49.4% (n = 77) of patients; severe stenotic plaques were found in 27.5% (n = 43) of patients. One patient found with an asymptomatic occlusion of the left ICA. The prevalence of major cardiovascular risk factors and high radiation dose increased proportionally with plaque severity. Low echogenicity plaque was found in 59 (37.8%) patients on the right side and 57 (36.5%) on the left side; long segment plaque in 49 (31.4%) patients on the right side and in 47 (30.1%) on the left side; an atypical location of the lesions in 42 (26.9%) patients on the right side and in 48 (30.8%) on the left side. Conclusions: The prevalence of occlusion and severe stenosis after radiotherapy for HNC was very low in our study population. Low echogenicity plaque, long segment plaque, and an atypical location were common findings. Classic cardiovascular risk factors appear to have had a causative role: a routine screening of radiotherapy-treated patients might be necessary only in patients with concomitant cardiovascular risk factors or exposed to high-dose neck radiation.

Early clinical outcomes for treatment of post-thrombotic syndrome and common iliac vein compression with a hybrid Oblique self-expanding nitinol stent - the TOPOS study.

Background: Physical attributes of conventional stents used in the ilio-caval territory are often unfavorable in the presence of external compression close to the bifurcation. A hybrid oblique stent was developed for the treatment of common iliac vein compression without compromising the contralateral iliac vein inflow. Patients and methods: The ongoing international monitored TOPOS study enrolled 60 patients with post-thrombotic syndrome (PTS) treated with the sinus-Obliquus stent (optimed) and provisional distal stent extension. At 3-month follow-up, patency rates were obtained from duplex ultrasound, and clinical outcomes were assessed by the Villalta score, revised venous severity score (rVCSS), pain intensity score and chronic venous disease quality of life questionnaire (CIVIQ-20). Results: Mean age was 46.6 ± 14.9 years (68.3 % women). Mean number of implanted stents was 1.9 ± 0.6; 12 (20 %) patients received the hybrid oblique stent only. Forty-eight (80 %) patients had distal stent extension, and 42 (70 %) had stents below the inguinal ligament. Four (7 %) patients (all with stent extension) developed stent thrombosis. Primary and secondary patency rates at 3 months were 93.1 % (95 %CI 83.3-98.1 %), and 100 % (95 %CI 93.8-100 %), respectively. Improvement in Villalta, rVCSS, CIVIQ-20, and pain intensity score from baseline to 3-month follow-up was 6.9 ± 1.4 points (95 %CI 4.1-9.8; p < 0.0001), 3.4 ± 1.0 points (95 %CI 1.3-5.4 points; p < 0.01), 13.6 ± 2.7 points (95 %CI 8.2-19.0 points; p < 0.0001), and 2.4 ± 0.5 (95 %CI 1.4-3.3; p < 0.0001), respectively. At follow-up, 38 (63 %) patients were free from the PTS and none developed contralateral deep vein thrombosis. Conclusions: In patients with PTS and common iliac vein compression, treatment with the hybrid oblique stent with provisional stent extension resulted in high patency rates and improvement in PTS severity and quality of life at 3-month. Two-year results of TOPOS will assess the durability of this treatment.

Venous Thromboembolism and Renal Impairment: Insights from the SWIss Venous ThromboEmbolism Registry (SWIVTER).

Renal impairment (RI) has increased substantially over the last decades. In the absence of data from confirmatory research, real-life data on anticoagulation treatment and clinical outcomes of venous thromboembolism (VTE) in patients with RI are needed. In the SWIss Venous ThromboEmbolism Registry (SWIVTER), 2,062 consecutive patients with objectively confirmed VTE were enrolled. In the present analysis, we compared characteristics, initial and maintenance anticoagulation, and adjusted 90-day clinical outcomes of those with (defined as estimated creatinine clearance < 30 mL/min) and without severe RI. Overall, 240 (12%) patients had severe RI; they were older, and more frequently had chronic and acute comorbidities. VTE severity was similar between patients with and without severe RI. Initial anticoagulation in patients with severe RI was more often performed with unfractionated heparin (44 vs. 24%), and less often with low-molecular-weight heparin (LMWH) (52 vs. 61%) and direct oral anticoagulants (DOACs; 4 vs. 12%). Maintenance anticoagulation in patients with severe RI was more frequently managed with vitamin K antagonists (70 vs. 60%) and less frequently with DOAC (12 vs. 21%). Severe RI was associated with increased risk of 90-day mortality (9.2 vs. 4.2%, hazard ratio [HR]: 2.27, 95% confidence interval [CI]: 1.41-3.65), but with similar risk of recurrent VTE (3.3 vs. 2.8%, HR: 1.19, 95% CI: 0.57-2.52) and major bleeding (2.1 vs. 2.0%, HR: 1.05, 95% CI: 0.41-2.68). In patients with severe RI, the use of LMWH versus any other treatment was associated with reduced mortality (HR: 0.37; 95% CI: 0.14-0.94; p = 0.036) and similar rate of major bleeding (HR: 0.59, 95% CI: 0.17-2.00; p = 0.39). Acute or chronic comorbidities rather than VTE severity or recurrence may explain increased early mortality in patients with severe RI. The higher rate of VTE recurrence, specifically fatal events, than major bleeding reinforces the need for effective anticoagulation in VTE patients with severe RI.

Risk stratification of elderly patients with acute pulmonary embolism.

BACKGROUND: Combining high-sensitivity cardiac Troponin T (hs-cTnT), NT-pro-B-type natriuretic peptide (NT-proBNP) and high-sensitivity C-reactive protein (hs-CRP) may improve risk stratification of patients with pulmonary embolism (PE) beyond the PESI risk score. METHODS: In the prospective multicentre SWITCO65+ study, we analysed 214 patients ≥ 65 years with a new submassive PE. Biomarkers and clinical information for the PESI risk score were ascertained within 1 day after diagnosis. Associations of hs-TnT, NT-proBNP, hs-CRP and the PESI risk score with the primary endpoint defined as 6-month mortality were assessed. The discriminative power of the PESI risk score and its combination with hs-cTnT, NT-proBNP and hs-CRP for 6-month mortality was compared using integrated discrimination improvement (IDI) index and net reclassification improvement (NRI). RESULTS: Compared with the lowest quartile, patients in the highest quartile had a higher risk of death during the first 6 months for hs-cTnT (adjusted HR 10.22; 95% CI 1.79-58.34; P = 0.009) and a trend for NT-proBNP (adjusted HR 4.3; 95% CI 0.9-20.41; P = 0.067) unlike hs-CRP (adjusted HR 1.97; 95% CI 0.48-8.05; P = 0.344). The PESI risk score (c-statistic 0.77 (95% CI 0.69-0.84) had the highest prognostic accuracy for 6-month mortality, outperforming hs-cTnT, NT-proBNP and hs-CRP (c-statistics of 0.72, 0.72, and 0.54), respectively. Combining all three biomarkers had no clinically relevant impact on risk stratification when added to the PESI risk score (IDI = 0.067; 95% CI 0.012-0.123; P = 0.018; NRI = 0.101 95% CI -0.099-0.302; P = 0.321). CONCLUSIONS: In elderly patients with PE, 6-month mortality can adequately be predicted by the PESI risk score alone.

Cessation of anticoagulation therapy following endovascular thrombus removal and stent placement for acute iliofemoral deep vein thrombosis.

Background: The optimal duration of anticoagulation therapy (AT) following catheter-based therapy of acute iliofemoral deep vein thrombosis (IFDVT) with stent placement is unknown. Theoretically, resolving the underlying obstructive iliac vein lesion by a stent may eliminate the main trigger for recurrence, the post-thrombotic syndrome (PTS), and the need for extended-duration AT. Patients and methods: From 113 patients with acute IFDVT who underwent endovascular thrombus removal and stent placement, we compared patency rates and clinical outcomes between 58 patients on limited-duration AT (3-12 month) and 55 patients on extended-duration AT (> 12 months). Results: Mean follow-up duration was 26 ± 18 (range 3-77) months; it was 24 ± 18 (range 3-69) months after cessation of AT in the limited-duration AT group. In comparison to patients with extended-duration AT, patients with limited-duration AT were younger (38 versus 54 years; p < 0.001), more often female (74 % versus 49 %; p = 0.01), and had less often prior venous thromboembolism (VTE) (9 % versus 35 %; p = 0.001). May-Thurner syndrome was more frequent in the limited-duration AT group (66 % versus 38 %; p = 0.004). Overall, primary and secondary patency rates at 24 months were 80 % (95 % CI, 70-87 %) and 95 % (95 % CI, 88-98 %), respectively, with no difference between the groups. Overall, 17 (15 %) patients developed recurrent VTE, of which 14 (82 %) events were thrombotic stent occlusions, and 13 (76 %) events occurred during AT. In the limited-duration AT group, 98 % patients were free from the PTS at two years with a VTE recurrence rate of 3.5 per 100 patient years after cessation of AT. Conclusions: In selected patients with acute IFDVT and patent venous stent, particularly in younger and otherwise healthy patients with May-Thurner syndrome, it appears to be safe to discontinue AT 3-12 months after endovascular treatment. Clinical Trial Registration: The study is registered on the National Institutes of Health website (ClinicalTrials.gov; identifier NCT02433054).

Early clinical outcomes of a novel rheolytic directional thrombectomy technique for patients with iliofemoral deep vein thrombosis.

BACKGROUND: Rheolytic thrombectomy (RT) for acute iliofemoral deep vein thrombosis (DVT) with first-generation techniques is often incomplete and adjunctive conventional catheter-directed thrombolysis (CDT) is required in more than half of patients to achieve venous patency. PATIENTS AND METHODS: From the prospective Bern Venous Stent Registry, we investigated rates of primary treatment success, primary patency, and post-thrombotic syndrome (PTS) from 40 consecutive patients (mean age 51 ± 19 years, 45 % women) with acute iliofemoral DVT, treated with a novel directional RT technology and stent placement. Overall, 24 patients were treated for native-vessel iliofemoral DVT (11 with single-session RT, 13 with bail-out RT after failed CDT) and 16 for iliofemoral stent thrombosis. Pulse-spray thrombolysis (r-tPA 10 mg) was performed in 29 (73 %) patients. The mean follow-up duration was 193 ± 132 days (minimum 90 days). RESULTS: Overall, primary treatment success of RT was 95 %; only two patients required adjunctive CDT to restore patency. In 24 patients with native-vessel DVT, six-month primary patency was 92 % (95 %CI 75-99 %), and 23 patients (96 %) were free from the PTS according to the Villalta score. In 16 patients with stent thrombosis, six-month primary patency was 63 % (95 %CI 35-85 %) and 50 % were free from PTS. Except for transient macroscopic haemoglobinuria in all patients, no other side effects were recorded. CONCLUSIONS: In patients with iliofemoral DVT of native or stented vessels, RT followed by stent placement appears to be effective and safe. The novel technique enables single-session DVT treatment in the majority of patients without the need for prolonged CDT.