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BACKGROUND: Although the two manifestations of venous thromboembolism (VTE), deep vein thrombosis (DVT) and pulmonary embolism (PE), vary considerably, the consensus guidelines recommend similar algorithms for therapeutic anticoagulation in both conditions. Real-world data assessing contemporary management strategies in PE and DVT alone may help tailoring future recommendations towards more individualized patient care. METHODS: In the present analysis, we compared demographics, comorbidities, treatment patterns, and clinical outcomes of PE versus DVT only among 2062 consecutive patients with confirmed VTE enrolled by 11 acute care hospitals between November 2012 and February 2015 in the SWIss Venous ThromboEmbolism Registry (SWIVTER). RESULTS: Overall, 1246 (60 %) patients were diagnosed with PE. In comparison to DVT alone, PE patients were older (66 vs. 59 years; p < 0.001), more frequently had acute and chronic comorbidities, less frequently had prior VTE and hormone replacement, and were less often pregnant. VTE was considered similarly often provoked in patients with PE and DVT alone (33.8 % vs. 33.5 %; p = 0.88). Anticoagulation for an indefinite duration was more often prescribed to patients with PE than those with DVT alone (45.7 vs. 19.6 %; p < 0.001), and PE diagnosis was the strongest independent predictor of indefinite anticoagulation (OR 3.21; 95 % CI 2.55-4.06; p < 0.001). Diagnosis of PE was associated with both increased risk of 90-day mortality (HR 2.31, 95 % CI 1.44-3.71; p = 0.001) and major bleeding (HR 3.88, 95 % CI 1.63-9.22; p = 0.002). CONCLUSIONS: Our analysis affirms differences in demographics, risk factors, and clinical outcomes of PE versus DVT alone. In routine clinical practice, duration of anticoagulation is being managed differently between the two manifestations of VTE, in contrast to recommendations of the current consensus guidelines.
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Embolia Pulmonar , Tromboembolia Venosa , Trombosis de la Vena , Humanos , Tromboembolia Venosa/terapia , Anticoagulantes/uso terapéutico , Embolia Pulmonar/terapia , Sistema de Registros , Trombosis de la Vena/terapiaRESUMEN
PURPOSE: Pseudoaneurysm (PA) of the access artery is a common and potentially severe complication after percutaneous endovascular interventions. Most PA require interventional therapy, including thrombin injection, covered stent implantation, or surgical repair, which are costly and associated with other complications. Treating PA by external compression is uncomfortable and time consuming, with a low success rate. By injecting local tumescence anesthesia around the PA and close to its neck, the tumescence anesthesia and echo-guided compression technique (TACT) aims to improve efficacy and patient's comfort. MATERIALS AND METHODS: We retrospectively reviewed all consecutive patients treated for femoral PA in our center from May 2009 to July 2019 and estimated efficacy and safety. Vascular specialists performed TACT according to a standardized protocol including ultrasound-guided injection of tumescence solution (45 ml of 0.9% saline, 15 ml of lidocaine 1%/epinephrine 5 µg/ml) in the soft tissue around the PA and its neck, local compression with the sonography probe until PA closure, and external compression by elastic belt for 3 hours. RESULTS: Among a total of 125 patients with femoral artery PA, 82 (65.6%) were treated by TACT (including 3 patients with haemorrhagic shock), 14 (11.2%) by thrombin injection; 12 (9.6%) by endovascular interventions; 8 (6.4%) by open surgery; and 9 (7.2%) conservatively. In patients treated by TACT, PA neck was short (<1 cm) in 51.8% and mean cavity diameter 30 ± 23 mm. After injection of 58 ± 8 ml of tumescence solution, mean time of echo-guided compression was 12 ± 8 minutes. Pseudoaneurysm was successfully closed in 92.7% after the first attempt and in 96.3% after the second attempt. The intervention was well tolerated, without any adverse event. CONCLUSION: Tumescence anesthesia and echo-guided compression technique (TACT) is an effective and safe treatment for PA. Compared to other therapies, TACT is minimally invasive and widely available for minimal costs, even for large PA and in unstable patients. CLINICAL IMPACT: Tumescence anesthesia and echo-guided compression technique seems to be an efficient, safe, and a fair economical choice in comparison with alternative techniques. The implementation of this procedure is simple with low risk of complications. Based on the results of this study, we believe that TACT should be considered as the first-line treatment of most iatrogenic PA.
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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.
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Síndrome Postrombótico , Trombosis de la Vena , Femenino , Vena Femoral/diagnóstico por imagen , Humanos , Vena Ilíaca/diagnóstico por imagen , Masculino , Persona de Mediana Edad , Vena Poplítea/diagnóstico por imagen , Vena Poplítea/patología , Síndrome Postrombótico/etiología , Síndrome Postrombótico/terapia , Calidad de Vida , Terapia Trombolítica/efectos adversos , Resultado del Tratamiento , Trombosis de la Vena/complicaciones , Trombosis de la Vena/diagnóstico por imagen , Trombosis de la Vena/terapiaRESUMEN
BACKGROUND: Peripheral arterial disease is a progressive atherosclerotic disease with symptoms ranging from an intermittent claudication to acute critical limb ischemia and amputations. Drug-coated balloons and stents were developed to prevent neo-intimal proliferation and restenosis after percutaneous transluminal angioplasty. Randomized controlled trials showed that drug-coated, notably paclitaxel-coated, devices reduce restenosis, late lumen loss, and the need for target lesion re-vascularization compared with uncoated ones. However, the size of these trials was too small to prove superiority for "hard" clinical outcomes. Moreover, available studies were characterized by too restrictive eligibility criteria. Finally, it remains unclear whether paclitaxel-coated balloons may impair long-term survival. Alternative drug-coated balloons, the so-called limus-based analogs, have been approved for clinical use in patients with peripheral arterial disease. By encapsulating sirolimus in phospholipid drug nanocarriers, they optimize adhesion properties of sirolimus and provide better bioavailability. METHODS: In this investigator-initiated all-comer open-label phase III randomized controlled trial, we will evaluate whether sirolimus-coated balloon angioplasty is non-inferior and eventually superior, according to a predefined hierarchical analysis, to uncoated balloon angioplasty in adults with infra-inguinal peripheral arterial disease requiring endovascular angioplasty. Key exclusion criteria are pregnancy or breastfeeding, known intolerance or allergy to sirolimus, and participation in a clinical trial during the previous 3 months. The primary efficacy outcome is the composite of two clinically relevant non-subjective "hard" outcomes: unplanned major amputation of the target limb and endovascular or surgical target lesion re-vascularization for critical limb ischemia occurring within 1 year of randomization. The primary safety outcome includes death from all causes. DISCUSSION: By focusing on clinically relevant outcomes, this study will provide useful information on the efficacy and safety of sirolimus-coated balloon catheters for infra-inguinal peripheral arterial disease in a representative ("all-comer") population of unselected patients. As regulatory agencies had raised safety concerns in patients exposed to paclitaxel-coated devices (versus uncoated ones), collect mortality data up to 5 years after randomization will be collected. TRIAL REGISTRATION: ClinicalTrials.gov NCT04238546.
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Angioplastia de Balón , Paclitaxel , Enfermedad Arterial Periférica , Sirolimus , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/métodos , Ensayos Clínicos Fase III como Asunto , Materiales Biocompatibles Revestidos , Constricción Patológica , Arteria Femoral , Humanos , Paclitaxel/efectos adversos , Enfermedad Arterial Periférica/terapia , Arteria Poplítea , Ensayos Clínicos Controlados Aleatorios como Asunto , Sirolimus/efectos adversos , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
PURPOSE: Percutaneous transluminal angioplasty (PTA) with conventional plain old balloon (POBA) and/or drug-coated balloon (DCB) is the primary intervention to treat peripheral artery stenoses. However, acute dissections during the procedure and potential for future target lesion revascularization remain procedural complications. The purpose of this study was to assess the acute and 12-month outcomes in patients who underwent novel vessel preparation with longitudinal, controlled-depth micro-incisions prior to PTA. MATERIALS AND METHODS: Patients with symptomatic lower extremity peripheral arterial disease with a Rutherford class of 2 to 6 and >70% de novo stenosis of the superficial femoral or popliteal arteries were included in this retrospective study. Patients with thrombotic or embolic lesions, restenosis, or in-stent restenosis were excluded. The FLEX Vessel Prep System (FLEX VP) was used to prepare the vessel prior to PTA by creating micro-incisions at the target lesion. The FLEX VP was followed by POBA or paclitaxel DCB. RESULTS: The study included 65 patients. Lesion characteristics were 90% median stenosis (range = 70%-100%), 75.4% mild-to-severe calcifications, and 33.8% occlusion rate, and median lesion length was 196 (range = 10-480) mm. Following vessel preparation, 82.1% of the patients had low severity dissection or no flow-limiting dissection. The provisional stent rate postprocedure was 16.9%, with a median stent length of 60 mm. The freedom from target lesion revascularization (FFTLR) in 63 evaluable patients at 6 and 12 months was 98.4% and 93.7%, respectively. Freedom from amputation was 100%. CONCLUSION: In this real-world/all-comers patient population with long, stenotic lesions across the calcification spectrum, vessel preparation with longitudinal micro-incisions prior to PTA was associated with low dissection rate, low dissection severity, low stent implantation, and high FFTLR with the absence of amputation at 12 months relative to published reports in long-lesion cohorts. These results support vessel preparation via micro-incisions.
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Angioplastia de Balón , Enfermedad Arterial Periférica , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/métodos , Materiales Biocompatibles Revestidos , Constricción Patológica , Arteria Femoral/diagnóstico por imagen , Arteria Femoral/cirugía , Humanos , Extremidad Inferior , Enfermedad Arterial Periférica/complicaciones , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/terapia , Arteria Poplítea/diagnóstico por imagen , Arteria Poplítea/cirugía , Estudios Prospectivos , Estudios Retrospectivos , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
We aimed to evaluate the impact of age, sex, and their interactions with provoking risk factors for deep vein thrombosis (DVT). In addition, we intended to provide additional insights on risk factors associated with the isolated distal versus proximal presentation of first symptomatic acute DVT, both being characterized by different prognosis. In the present analysis from the SWIss Venous ThromboEmbolism Registry (SWIVTER), we compared demographic and baseline characteristics in patients with isolated distal (n = 184; 35%) versus proximal (n = 346) DVT of the lower limbs without symptomatic pulmonary embolism, and identified factors related with the presenting thrombosis location. In the overall population, mean age was 59 ± 19 years, 266 (50%) were women, 106 (20%) patients had cancer, 86 (16%) recent surgery, and 52 (10%) acute infection/sepsis. In a multivariable analysis, recent surgery [odds ratio (OR) 2.92, 95% confidence interval (CI) 1.80-4.73] was independently associated with a diagnosis of isolated distal DVT, whereas cancer (OR 2.01, 95% CI 1.20-3.35), male sex aged 41 to 75 years (OR 2.21, 95% CI 1.33-3.67), and acute infection/sepsis (OR 2.71, 95% CI 1.29-5.66) with a diagnosis of proximal DVT. In SWIVTER, age, sex, and several provoking risk factors for VTE appeared to be related with the presenting location of first symptomatic DVT. Cancer, male sex, and acute infection/sepsis were associated with a proximal location of DVT, whereas recent surgery was associated with a distal presentation, likely acting as confounders for the association between thrombosis location and prognosis.
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Neoplasias , Embolia Pulmonar , Sepsis , Trombosis , Tromboembolia Venosa , Trombosis de la Vena , Adulto , Anciano , Anticoagulantes , Femenino , Humanos , Masculino , Persona de Mediana Edad , Neoplasias/complicaciones , Embolia Pulmonar/complicaciones , Recurrencia , Sistema de Registros , Factores de Riesgo , Sepsis/complicaciones , Trombosis/complicaciones , Tromboembolia Venosa/complicaciones , Tromboembolia Venosa/etiología , Trombosis de la Vena/etiologíaRESUMEN
INTRODUCTION: Pulmonary embolism (PE) and deep vein thrombosis (DVT), the two clinical manifestations of venous thromboembolism (VTE), constitute a major global burden of cardiovascular disease. They are often referred to as one disease but several patient characteristics, risk factors, real-world treatment, and clinical outcomes may differ substantially between PE and DVT alone. MATERIALS AND METHODS: We conducted a narrative review of the state-of-the-art literature on the topic of PE and DVT alone using PubMed, Google scholar, and MEDLINE databases and the most established international consensus statement guidelines for the management of VTE, focusing on the recommendations for diagnosis and treatment but also including epidemiological and clinical characteristics of VTE, highlighting similarities and differences between PE and DVT alone. RESULTS: Several patient characteristics, risk factors, clinical manifestations, and outcomes differ substantially between PE versus DVT alone. Nevertheless, recommendations for both diagnosis and treatment are strikingly similar in the current guidelines for the management of DVT and PE, except for the indication for advanced reperfusion therapies. CONCLUSIONS: The differences in risk factors, clinical manifestations, and clinical outcomes between patients with PE versus DVT alone are only marginally addressed in the current consensus guidelines. More data is needed allowing proposal of evidence-based adjustments in the diagnostic and therapeutic strategies for these two manifestations of VTE. Tailored risk stratification and individualized management strategies for patients with PE and DVT alone may lead to a better prognosis, less recurrence and complications, and possibly to a gain of quality-adjusted life years in patients with VTE.
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Embolia Pulmonar , Tromboembolia Venosa , Trombosis de la Vena , Humanos , Embolia Pulmonar/diagnóstico , Embolia Pulmonar/epidemiología , Recurrencia , Factores de Riesgo , Trombosis de la Vena/diagnóstico , Trombosis de la Vena/epidemiologíaRESUMEN
The hemodynamic behavior following endovascular treatment of patients with peripheral arterial disease plays a significant role on the occurrence of restenosis in femoro-popliteal (FP) arteries. The atheroprone flow conditions that are generally accepted to promote restenosis can be calculated by computational fluid dynamics (CFD) analyses, and these results can be used to assess individualized treatment outcomes. However, the impact of endovascular therapy on the flow behaviors of FP arteries are still poorly understood, as the imaging modalities used in existing numerical works (X-ray angiography, computed tomography angiography) are unable to accurately represent the post-treatment arterial geometry due to their low resolutions. Therefore, this study proposes a new algorithm that combines intra-arterial lumen geometry obtained from high-resolution optical coherence tomography (OCT) images with centerlines generated from X-ray images to reconstruct the FP artery with an in-plane resolution of 10 µm. This superior accuracy allows modeling characteristic geometrical structures, such as angioplasty-induced arterial dissections, that are too small to be reconstructed with other imaging modalities. The framework is applied on the clinical data of patients treated either with only-percutaneous transluminal angioplasty (PTA) (n = 4) or PTA followed by stenting (n = 4). Based on the generated models, PTA was found to cause numerous arterial dissections, covering approximately 10% of the total surface area of the lumen, whereas no dissections were identified in the stented arteries. CFD simulations were performed to investigate the hemodynamic conditions before and after treatment. Regardless of the treatment method, the areas affected by low time-averaged wall shear stress (< 0.5 Pa) were significantly higher (p < 0.05) following endovascular therapy (pre-PTA: 0.95 ± 0.59 cm2; post-PTA: 2.10 ± 1.09cm2; post-stent: 3.10 ± 0.98 cm2). There were no statistical differences between the PTA and the stent groups. However, within the PTA group, adverse hemodynamics were mainly concentrated at regions created by arterial dissections, which may negatively impact the outcomes of a leave-nothing-behind strategy. These observations show that OCT-based numerical models have great potential to guide clinicians regarding the optimal treatment approach.
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Simulación por Computador , Arteria Femoral/diagnóstico por imagen , Hemodinámica , Enfermedad Arterial Periférica/diagnóstico por imagen , Arteria Poplítea/diagnóstico por imagen , Tomografía de Coherencia Óptica/métodos , Anciano , Anciano de 80 o más Años , Angiografía/métodos , Femenino , Arteria Femoral/fisiopatología , Humanos , Masculino , Enfermedad Arterial Periférica/fisiopatología , Arteria Poplítea/fisiopatologíaRESUMEN
OBJECTIVE: The use of endovenous thermal ablation (ETA) for the treatment of truncal varicose veins has been increasing worldwide; however, uncertainty remains regarding the need for thromboprophylaxis and follow-up of patients undergoing this minimally invasive procedure. A nationwide survey of among physicians performing ETA was conducted to assess the thromboprophylaxis practice and follow-up protocols after ETA in Switzerland. METHODS: A questionnaire was sent to all ETA-certified physicians (n = 193) in Switzerland. The survey covered procedure type, thromboprophylaxis (including pharmacologic and compression therapy), duplex ultrasound follow-up examinations, and the management of endovenous heat-induced thrombosis (EHIT). RESULTS: Overall, 121 responses were received, for a response rate of 62.7%. Of the 121 respondents, 71 were vascular medicine specialists (58.7%) and 46 were general or vascular surgeons (38.0%), representing the two largest groups of specialists, followed by 2 dermatologists (1.7%) and 2 interventional radiologists (1.7%). Pharmacologic thromboprophylaxis after ETA was always used by 86 physicians (71.1%), nearly always by 8 (6.6%), frequently used by 5 (4.1%), rarely used by 21 (17.4%), and never by 1 physician (0.8%). A direct oral anticoagulant drug was the preferred type of thromboprophylaxis used by 92 physicians (77.3%). The first dose of thromboprophylaxis was mostly administered immediately after intervention by 53 physicians (53.7%). The duration of postablation thromboprophylaxis ranged from 1 to 21 days, with 7 to 10 days used by 57 physicians. Compression therapy was used by all physicians, with large variation in duration ranging from 1 to 42 days after a single ETA session and after ETA with concomitant phlebectomy. Postablation duplex ultrasonography was performed routinely by 120 respondents (99.2%), and 84 respondents (69.4%) performed two to three duplex ultrasound scans. Management of EHIT depended on the EHIT class and differed widely among the physicians. CONCLUSIONS: Our nationwide survey on thromboprophylaxis practices after ETA of truncal varicose veins in Switzerland showed that most physicians use pharmacologic thromboprophylaxis, with a direct oral anticoagulant drug the preferred agent. However, the timing of the first dose and the duration of thromboprophylaxis varied widely among the respondents, reflecting the uncertainty in this domain owing to the absence of high-quality evidence-based guidelines.
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Procedimientos Quirúrgicos Ambulatorios , Ablación por Catéter/efectos adversos , Procedimientos Endovasculares/efectos adversos , Pautas de la Práctica en Medicina , Tromboembolia/prevención & control , Várices/cirugía , Anticoagulantes/administración & dosificación , Anticoagulantes/uso terapéutico , Estudios Transversales , Esquema de Medicación , Encuestas de Atención de la Salud , Humanos , Medias de Compresión , Suiza , Tromboembolia/diagnóstico por imagen , Ultrasonografía Doppler DúplexRESUMEN
OBJECTIVE: In patients with cancer-associated venous thromboembolism (VTE), the risk of recurrence is similar after incidental and symptomatic events. It is unknown whether the same applies to incidental VTE not associated with cancer. METHODS AND RESULTS: We compared baseline characteristics, anticoagulation therapy, all-cause mortality, and VTE recurrence rates at 90 days between patients with incidental (n = 131; 52% without cancer) and symptomatic (n = 1,931) VTE included in the SWIss Venous ThromboEmbolism Registry (SWIVTER). After incidental VTE, 114 (87%) patients received anticoagulation therapy for at least 3 months. The mortality rate was 9.2% after incidental and 8.4% after symptomatic VTE for hazard ratio (HR) 1.10 (95% confidence interval [CI] 0.49-2.50). After adjustment for competing risk of death, recurrence rate was 3.1 versus 2.8%, respectively, for sub-HR 1.07 (95% CI 0.39-2.93). These results were consistent among cancer (mortality: 15.9% vs. 12.6%; HR 1.32, 95% CI 0.67-2.59; recurrence: 4.8% vs. 4.7%; HR 1.02, 95% CI 0.30-3.42) and noncancer patients (mortality: 2.9% vs. 2.1%; HR 1.37, 95% CI 0.33-5.73; recurrence: 1.5% vs. 2.3%; HR 0.63, 95% CI 0.09-4.58). Patients with incidental VTE who received anticoagulation therapy for at least 3 months had lower mortality (4% vs. 41%) and recurrence rate (1% vs. 18%) compared with those who did not. CONCLUSION: In SWIVTER, more than half of incidental VTE events occurred in noncancer patients who often received anticoagulation therapy. Among noncancer patients, early mortality and recurrence rates were similar after incidental versus symptomatic VTE. Our findings suggest that anticoagulation therapy for incidental VTE may be beneficial regardless of the presence of cancer.
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Anticoagulantes/uso terapéutico , Neoplasias/epidemiología , Sistema de Registros , Tromboembolia Venosa/epidemiología , Adolescente , Adulto , Anciano , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Recurrencia , Análisis de Supervivencia , Suiza/epidemiología , Resultado del Tratamiento , Tromboembolia Venosa/tratamiento farmacológico , Tromboembolia Venosa/mortalidad , Adulto JovenRESUMEN
BACKGROUND: Angioplasty with stent placement is a therapeutic option for patients with acute thrombotic, postthrombotic, and nonthrombotic obstruction of the iliofemoral veins or inferior vena cava. Previous studies of steel-alloy stents described variable patency rate across indications. METHODS: The prospective Swiss Venous Stent Registry includes patients treated with self-expandable nitinol stents for deep venous obstruction. Routine follow-up visits include serial duplex ultrasound for stent patency assessment. The primary outcome was primary stent patency. The secondary outcome was venous thromboembolisms. We studied the rate of stent occlusion and potentially contributing factors. RESULTS: We included 379 patients: 160 with acute thrombotic, 193 with postthrombotic, and 26 with nonthrombotic deep vein obstruction. The mean age was 46±18 years; 55% were women. The cumulative 3-year primary patency rate was 80.5% (95% CI, 73.0%-88.0%) for acute thrombotic, 59.2% (95% CI, 50.4%-68.0%) for postthrombotic, and 100% for nonthrombotic obstruction (log-rank, P<0.0001). Annualized rates of stent occlusion or venous thromboembolism were 7.8 (acute thrombotic), 15.0 (postthrombotic), and 0 (nonthrombotic) events/100 patient-years. In a multivariable Cox regression model, postthrombotic femoral veins at baseline (hazard ratio, 2.64 [95% CI, 1.53-4.56]) and the number of stents (hazard ratio, 1.22 [95% CI, 1.06-1.40]) were associated with stent occlusion after conditioning for age, sex, and clinically relevant factors. CONCLUSIONS: The rate of stent occlusion (patency loss) and venous thromboembolism varies substantially across indications, also with dedicated venous nitinol stents. Patients with postthrombotic femoral veins and those who received multiple stents were characterized by the highest risk. Registration: URL: https://clinicaltrials.gov. Unique identifier: NCT02433054.
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Aleaciones , Vena Ilíaca , Adulto , Femenino , Humanos , Persona de Mediana Edad , Estudios Prospectivos , Estudios Retrospectivos , Stents , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
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.
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Procedimientos Endovasculares/instrumentación , Vena Ilíaca/diagnóstico por imagen , Stents , Ultrasonografía Doppler en Color , Enfermedades Vasculares/terapia , Vena Cava Inferior/diagnóstico por imagen , Adulto , Velocidad del Flujo Sanguíneo , Bases de Datos Factuales , Procedimientos Endovasculares/efectos adversos , Femenino , Humanos , Vena Ilíaca/fisiopatología , Masculino , Persona de Mediana Edad , Flebografía , Valor Predictivo de las Pruebas , Sistema de Registros , Estudios Retrospectivos , Resultado del Tratamiento , Enfermedades Vasculares/diagnóstico por imagen , Enfermedades Vasculares/fisiopatología , Grado de Desobstrucción Vascular , Vena Cava Inferior/fisiopatología , Adulto JovenRESUMEN
BACKGROUND: Patients with postthrombotic syndrome (PTS) treated with stents are at risk of stent thrombosis (ST). The incidence of ST in the presence and absence of anticoagulation therapy (AT) is unknown. Risk factors are not well understood. PATIENTS AND METHODS: From the prospective Swiss Venous Stent registry, we conducted a subgroup analysis of 136 consecutive patients with PTS. Incidence of ST was estimated from duplex ultrasound or venography, and reported for the time on and off AT. Baseline, procedural, and follow-up data were evaluated to identify factors associated with ST. RESULTS: Median follow-up was 20 (interquartile range [IQR] 9-40) months. AT was stopped in 43 (32%) patients after 12 (IQR 6-14) months. Cumulative incidence of ST was 13.7% (95% confidence interval [CI] 7.8-19.6%) and 21.2% (95% CI 13.2-29.2%) during the first 6 and 36 months, respectively. The time-adjusted incidence rate was 11.2 (95% CI 7.7-16.2) events per 100 patient-years, 11.3 (95% CI 7.3-17.3) for the period on, and 11.2 (95% CI 5.3-23.6) for the period off AT. May-Thurner syndrome (MTS) was associated with decreased incidence of ST (hazard ratio [HR] 0.37, 95% CI 0.15-0.91), whereas age < 40 years (HR 2.26, 95% CI 1.03-4.94), stents below the common femoral vein (HR 3.03, 95% CI 1.28-7.19), and postthrombotic inflow veins (HR 2.92, 95% CI 1.36-6.25) were associated with increased incidence. CONCLUSION: The 6-month incidence of ST was considerably high. Beyond 6 months, consecutive annual incidence rates persisted at 4.1 and 3.4% per year thereafter. Patients with higher incidence of ST were younger, had stents below the common femoral vein, postthrombotic leg inflow veins, and less often MTS. Incidence rates for the period on and off AT must be interpreted with caution. CLINICAL TRIAL REGISTRATION: The study is registered on the National Institutes of Health Web site (ClinicalTrials.gov; identifier NCT02433054).
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Anticoagulantes/uso terapéutico , Procedimientos Endovasculares , Síndrome Postrombótico/terapia , Stents/efectos adversos , Trombosis/prevención & control , Adulto , Aleaciones , Femenino , Vena Femoral/patología , Fibrinolíticos/farmacología , Estudios de Seguimiento , Humanos , Vena Ilíaca/patología , Incidencia , Masculino , Persona de Mediana Edad , Flebografía , Síndrome Postrombótico/complicaciones , Sistema de Registros , Factores de Riesgo , Suiza , Trombosis/complicaciones , Trombosis/epidemiología , Resultado del Tratamiento , Vena Cava Inferior/cirugíaRESUMEN
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.
Asunto(s)
Insuficiencia Renal Crónica/etiología , Tromboembolia Venosa/complicaciones , Femenino , Humanos , Masculino , Persona de Mediana Edad , Sistema de Registros , Insuficiencia Renal Crónica/patologíaRESUMEN
There is a need to improve the efficacy and safety of catheter-directed thrombolysis (CDT) for thrombo-occlusive diseases, and ultrasound-assisted CDT (USAT) is a promising approach. We tested if thrombolysis efficacy of USAT can be improved by adding gaseous microbubbles (MB). We developed an in vitro dynamic overflow model for iliofemoral deep vein thrombosis, and added MB to an USAT system with ultrasound energy and dose of tissue plasminogen activator according to clinical practice. A total of 64 clots (mean baseline weight of 8.23 ± 1.12 g, generated from citrated human whole blood from 7 healthy male volunteers) were randomly assigned to 1 of 4 study protocols of 30 minutes' duration: negative control, CDT, USAT, and USAT + MB.Thrombolysis efficacy was assessed by measuring the change in D-dimer levels in the overflow liquid and the percentage of clot weight reduction. Compared to negative control, change in D-dimer increased by 62% (p = 0.017), 128% (p = 0.002), and 177% (p < 0.001) in the CDT, USAT, and USAT + MB groups, respectively. D-dimer increase was greater in the USAT than in the CDT group (p = 0.014), and greater in the USAT + MB than in the USAT group (p = 0.033). Compared to negative control, percentage of clot weight reduction increased by 123% (p = 0.016), 154% (p = 0.002), and 233% (p < 0.001) in the CDT, USAT, and USAT + MB groups, respectively. Percentage of clot weight reduction was greatest in the USAT + MB group (p < 0.05 compared with all other groups). In conclusion, our in vitro study suggests that the thrombolytic efficacy of USAT in human whole blood clots can be improved by local administration of MB.
Asunto(s)
Arteria Femoral/patología , Fibrinolíticos/uso terapéutico , Terapia Trombolítica , Ultrasonografía Intervencional/métodos , Trombosis de la Vena/tratamiento farmacológico , Adulto , Catéteres , Arteria Femoral/diagnóstico por imagen , Productos de Degradación de Fibrina-Fibrinógeno/metabolismo , Voluntarios Sanos , Humanos , Masculino , Microburbujas , Activador de Tejido Plasminógeno/metabolismo , Resultado del Tratamiento , Ondas UltrasónicasRESUMEN
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).
Asunto(s)
Vena Femoral , Trombosis de la Vena , Adulto , Anticoagulantes , Femenino , Humanos , Vena Ilíaca , Persona de Mediana Edad , Stents , Terapia Trombolítica , Resultado del Tratamiento , Trombosis de la Vena/terapiaRESUMEN
BACKGROUND: The optimal anticoagulant following catheter-based therapy of acute iliofemoral deep vein thrombosis (IFDVT) is unknown. METHODS: From the Swiss Venous Stent registry, an ongoing prospective cohort study, we performed a subgroup analysis of patients with acute IFDVT who underwent catheter-based early thrombus removal followed by nitinol stent placement. Duplex ultrasound and Villalta scores were used to determine patency rates and incidence of the post-thrombotic syndrome (PTS) in patients treated with either rivaroxaban (nâ¯=â¯73) or a vitamin K-antagonist (VKA; nâ¯=â¯38) for a minimum duration of 3â¯months. RESULTS: Mean follow-up duration was 24⯱â¯19â¯months (range 3 to 77â¯months). Anticoagulation therapy was time-limited (3 to 12â¯months) in 56% of patients (47% in the rivaroxaban group and 58% in the VKA group, pâ¯=â¯0.26), with shorter mean duration of anticoagulation in the rivaroxaban group (180⯱â¯98â¯days versus 284⯱â¯199â¯days, pâ¯=â¯0.01). Overall, primary and secondary patency rates at 24â¯months were 82% (95%CI, 71-89%) and 95% (95%CI, 87-98%), respectively, with no difference between the rivaroxaban (87% [95%CI, 76-94%] and 95% [95%CI, 85-98%]) and the VKA group (72% [95%CI, 52-86%] and 94% [95%CI, 78-99%]; pâ¯>â¯0.10 for both). Overall, 86 (86%) patients were free from PTS at latest follow-up, with no difference between the rivaroxaban and the VKA groups (57 [85%] versus 29 [88%]; pâ¯=â¯0.76). Two major bleeding complications (1 in each group) occurred in the peri-interventional period, without any major bleeding thereafter. CONCLUSIONS: In patients with acute IFDVT treated with catheter-based early thrombus removal and venous stent placement, the effectiveness and safety of rivaroxaban and VKA appear to be similar. CLINICAL TRIAL REGISTRATION: The study is registered on the National Institutes of Health website (ClinicalTrials.gov; identifier NCT02433054).
Asunto(s)
Anticoagulantes/uso terapéutico , Procedimientos Endovasculares , Síndrome Postrombótico/etiología , Rivaroxabán/uso terapéutico , Terapia Trombolítica , Trombosis de la Vena/complicaciones , Trombosis de la Vena/terapia , Vitamina K/antagonistas & inhibidores , Adulto , Anciano , Cateterismo/métodos , Procedimientos Endovasculares/métodos , Inhibidores del Factor Xa/uso terapéutico , Femenino , Vena Femoral/patología , Humanos , Vena Ilíaca/patología , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Stents , Terapia Trombolítica/métodos , Resultado del Tratamiento , Grado de Desobstrucción Vascular/efectos de los fármacos , Trombosis de la Vena/tratamiento farmacológico , Trombosis de la Vena/patologíaRESUMEN
Due to the manifold treatment options for the management of acute pulmonary embolism, state-of-the-art management requires risk stratification for choosing the adapted treatment for each patient. Reperfusion therapy is an integral part of therapy for patients with pulmonary embolism at high risk for mortality, but its role in patients with intermediate risk pulmonary embolism is more debated. The largest amount of evidence exists for systemic thrombolysis, which is an efficient therapy, but at the prize of an increased bleeding risk. In recent years, various types of catheter-based reperfusion therapies have been introduced, and evidence is growing that this therapy is as efficient as systemic thrombolysis, but with a more favourable safety profile. Surgical embolectomy remains a good alternative for unstable patients, especially for those with absolute contraindications for thrombolysis or after failed systemic thrombolysis. While the early benefits of reperfusion therapy are well documented, evidence for long-term benefit is still scarce. The scope of this review is to summarize the evidence for the currently available reperfusion therapies in the management of acute pulmonary embolism.
Asunto(s)
Embolectomía/métodos , Embolia Pulmonar/terapia , Reperfusión/métodos , Terapia Trombolítica/métodos , Enfermedad Aguda , Catéteres , Manejo de la Enfermedad , Humanos , Embolia Pulmonar/diagnóstico , Embolia Pulmonar/epidemiología , Embolia Pulmonar/cirugíaRESUMEN
BACKGROUND: The aim of the study was to investigate venous patency and clinical outcomes for endovascular treatment of iliofemoral venous obstruction in patients with post-thrombotic syndrome (PTS) and non-thrombotic iliac vein lesion (NIVL) with dedicated self-expanding nitinol stents. PATIENTS AND METHODS: Data were collected from the prospective Swiss Venous Stent Registry, enrolling consecutive patients with a standardized follow-up procedure since January 2008. Patency was evaluated by duplex sonography and clinical outcome by various scores including the Villalta score at baseline, three, six, and 12 months, and then annually after endovascular therapy. RESULTS: Overall, 93 patients (64 PTS, 29 NIVL) were analysed. Mean follow-up time was 20 ± 16 (range 3-70) months. A total of 11 (12 %) patients had a stent occlusion, all of which occurred in the PTS group, and 13 (14 %) patients had a symptomatic stent stenosis. Primary patency was 79 % (95 % CI 68-87 %) at 12 months and 72 % (95 % CI 59-82 %) at 24 months. In PTS patients, primary patency at 12 months was 75 % (95 % CI 61-84 %) vs. 89 % (95 % CI 63-97 %) in NIVL patients (p = 0.10). Secondary patency at 24 months was 94 % (95 % CI 84-98 %) in PTS and 100 % in NIVL, p = 0.19). Overall, 62 (67 %) patients were free from PTS at the latest follow-up with a Villalta score < 5 points. Predictive factors for the loss of primary patency were stents placed below the inguinal ligament (OR 2.59, 95 % CI, 0.99-6.84, p = 0.05). CONCLUSIONS: In symptomatic patients with chronic iliofemoral vein obstruction, endovascular therapy with self-expanding nitinol stents was associated with favourable patency rates and clinical improvement in the majority of patients.