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1.
Circulation ; 139(9): 1162-1173, 2019 02 26.
Article in English | MEDLINE | ID: mdl-30586751

ABSTRACT

BACKGROUND: The ATTRACT trial (Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis) previously reported that pharmacomechanical catheter-directed thrombolysis (PCDT) did not prevent postthrombotic syndrome (PTS) in patients with acute proximal deep vein thrombosis. In the current analysis, we examine the effect of PCDT in ATTRACT patients with iliofemoral deep vein thrombosis. METHODS: Within a large multicenter randomized trial, 391 patients with acute deep vein thrombosis involving the iliac or common femoral veins were randomized to PCDT with anticoagulation versus anticoagulation alone (No-PCDT) and were followed for 24 months to compare short-term and long-term outcomes. RESULTS: Between 6 and 24 months, there was no difference in the occurrence of PTS (Villalta scale ≥5 or ulcer: 49% PCDT versus 51% No-PCDT; risk ratio, 0.95; 95% CI, 0.78-1.15; P=0.59). PCDT led to reduced PTS severity as shown by lower mean Villalta and Venous Clinical Severity Scores ( P<0.01 for comparisons at 6, 12, 18, and 24 months), and fewer patients with moderate-or-severe PTS (Villalta scale ≥10 or ulcer: 18% versus 28%; risk ratio, 0.65; 95% CI, 0.45-0.94; P=0.021) or severe PTS (Villalta scale ≥15 or ulcer: 8.7% versus 15%; risk ratio, 0.57; 95% CI, 0.32-1.01; P=0.048; and Venous Clinical Severity Score ≥8: 6.6% versus 14%; risk ratio, 0.46; 95% CI, 0.24-0.87; P=0.013). From baseline, PCDT led to greater reduction in leg pain and swelling ( P<0.01 for comparisons at 10 and 30 days) and greater improvement in venous disease-specific quality of life (Venous Insufficiency Epidemiological and Economic Study Quality of Life unit difference 5.6 through 24 months, P=0.029), but no difference in generic quality of life ( P>0.2 for comparisons of SF-36 mental and physical component summary scores through 24 months). In patients having PCDT versus No-PCDT, major bleeding within 10 days occurred in 1.5% versus 0.5% ( P=0.32), and recurrent venous thromboembolism over 24 months was observed in 13% versus 9.2% ( P=0.21). CONCLUSIONS: In patients with acute iliofemoral deep vein thrombosis, PCDT did not influence the occurrence of PTS or recurrent venous thromboembolism. However, PCDT significantly reduced early leg symptoms and, over 24 months, reduced PTS severity scores, reduced the proportion of patients who developed moderate-or-severe PTS, and resulted in greater improvement in venous disease-specific quality of life. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00790335.


Subject(s)
Anticoagulants/adverse effects , Endovascular Procedures/adverse effects , Femoral Vein/surgery , Iliac Vein/surgery , Mechanical Thrombolysis/adverse effects , Postthrombotic Syndrome/epidemiology , Acute Disease , Adult , Anticoagulants/administration & dosage , Female , Humans , Male , Middle Aged , Postthrombotic Syndrome/etiology
2.
J Vasc Surg ; 59(2): 456-64, 2014 Feb.
Article in English | MEDLINE | ID: mdl-23958068

ABSTRACT

BACKGROUND: Extensive deep venous thrombosis (DVT) during pregnancy is usually treated with anticoagulation alone, risking significant post-thrombotic syndrome (PTS) in young patients. Catheter-directed thrombolysis (CDT) and operative venous thrombectomy have been safely and effectively used in nonpregnant patients, demonstrating significant reduction in post-thrombotic morbidity. This report reviews short- and long-term outcomes of 13 patients with extensive DVT of pregnancy treated with a strategy of thrombus removal. METHODS: From 1999 to 2013, 13 patients with iliofemoral DVT during pregnancy were offered CDT, pharmacomechanical thrombolysis (PMT), and/or venous thrombectomy. Gestational age ranged from 8 to 34 weeks. Fetal monitoring was performed throughout hospitalization. Radiation exposure was minimized with pelvic lead shields, focal fluoroscopy, and limited angiographic runs. Follow-up included objective vein evaluation using venous duplex and PTS assessment using the Villalta scale. RESULTS: CDT and/or PMT were used in 11 patients. Two patients underwent venous thrombectomy alone, and one patient had operative thrombectomy as an adjunct to CDT and PMT. Each patient had complete or near-complete thrombus resolution and rapid improvement in clinical symptoms. Eight of 11 having CDT or PMT underwent venoplasty and stenting of the involved iliac veins. Twelve of the 13 delivered healthy infants at term. One patient opted for termination of her pregnancy. Mean patient and gestational ages were 26 years and 26 weeks, respectively. Mean follow-up was 1.3 years, with only one recurrence. Duplex ultrasonography demonstrated patent veins in all but one patient and normal valve function in 10 patients. Eleven patients had Villalta scores <5 (considered normal), with a mean score of 0.7. CONCLUSIONS: Extensive DVT of pregnancy can be effectively and safely treated with a strategy of thrombus removal, resulting in a patent venous system, normal valve function in many, prevention of PTS, and reduction in recurrence.


Subject(s)
Femoral Vein/surgery , Iliac Vein/surgery , Pregnancy Complications, Cardiovascular/therapy , Thrombectomy , Thrombolytic Therapy , Venous Thrombosis/therapy , Adult , Female , Femoral Vein/diagnostic imaging , Femoral Vein/physiopathology , Gestational Age , Humans , Iliac Vein/diagnostic imaging , Iliac Vein/physiopathology , Phlebography , Postthrombotic Syndrome/prevention & control , Pregnancy , Pregnancy Complications, Cardiovascular/diagnosis , Pregnancy Complications, Cardiovascular/physiopathology , Retrospective Studies , Secondary Prevention , Time Factors , Treatment Outcome , Ultrasonography, Doppler, Duplex , Vascular Patency , Venous Thrombosis/diagnosis , Venous Thrombosis/physiopathology
3.
Ann Vasc Surg ; 28(7): 1589-94, 2014 Oct.
Article in English | MEDLINE | ID: mdl-24911801

ABSTRACT

BACKGROUND: Massive pulmonary embolism (MPE) is a significant cause of mortality and, with submassive pulmonary embolism (SPE), is associated with chronic thromboembolic pulmonary hypertension, resulting in ongoing patient morbidity. Standard treatment is anticoagulation, although systemic thrombolytic therapy has been shown to reduce early mortality in patients with MPE and improve cardiopulmonary hemodynamics in patients with SPE. However, systemic lysis is associated with significant bleeding risk. Early reports of catheter-directed techniques (CDT) suggest favorable outcomes in patients with MPE and SPE with reduced risk of hemorrhage. The purpose of this study is to evaluate efficacy and safety outcomes in MPE and SPE patients treated with CDT. METHODS: Seventeen patients treated with CDT for MPE and SPE were clinically and hemodynamically evaluated. Patients were grouped by severity of pulmonary embolism: MPE (n = 5) or SPE (n = 12). Pre- and post-interventional measures were assessed, including pulmonary artery pressures (PAPs), cardiac biomarkers, tricuspid regurgitation, right ventricular (RV) dilatation, and systolic function. Nine patients had contraindications to systemic thrombolytic therapy. RESULTS: PAP was elevated in 94% at presentation. The average dose of recombinant tissue plasminogen activator (rt-PA) was 31 mg; 44 mg in MPE and 26 mg in SPE. Pre- and post-intervention PAPs were recorded in 13 patients. All demonstrated an acute reduction in posttreatment PAP, averaging 37%. At presentation, all MPE and 10 (83%) SPE patients showed both RV dilatation and reduced function on echocardiography, which normalized in 76% (13/17) and improved in 24% (4/17) after CDT. Patients who demonstrated left ventricle underfilling before CDT (2 [40%] MPE and 2 [20%] SPE) normalized after CDT. All MPE and 11 (92%) SPE patients had tricuspid regurgitation on echocardiography pretreatment, which resolved in 60% and 58% of MPE and SPE patients, respectively. One delayed mortality occurred in an MPE patient who was hypotensive and hypoxic at presentation. There was one puncture site bleed. CONCLUSIONS: CDT was successful in the acute management of patients with MPE and SPE. CDT rapidly restores cardiopulmonary hemodynamics using reduced doses of rt-PA. These observations suggest that CDT should be considered in MPE and SPE patients to rapidly restore cardiopulmonary hemodynamics, reduce acute morbidity and mortality, reduce bleeding complications, and potentially avoid long-term morbidity.


Subject(s)
Catheterization/methods , Fibrinolytic Agents/administration & dosage , Pulmonary Embolism/drug therapy , Thrombolytic Therapy/methods , Tissue Plasminogen Activator/administration & dosage , Biomarkers/analysis , Echocardiography , Female , Hemodynamics , Humans , Male , Middle Aged , Pulmonary Embolism/diagnostic imaging , Retrospective Studies , Risk Factors , Systole , Treatment Outcome , Tricuspid Valve Insufficiency/diagnostic imaging , Ventricular Dysfunction, Right/diagnostic imaging
4.
J Vasc Surg ; 55(1): 129-35, 2012 Jan.
Article in English | MEDLINE | ID: mdl-21890310

ABSTRACT

BACKGROUND: The postthrombotic syndrome is a debilitating condition occurring in 30% to 50% of patients with lower extremity deep vein thrombosis (DVT). Following iliofemoral DVT, however, postthrombotic morbidity is especially severe, due to occlusion of the common femoral vein (CFV) and iliac veins. While endoluminal recanalization appears effective in restoring patency to the iliac venous system, infrainguinal obstruction of the CFV remains a problem. The purpose of this study is to report preliminary observations of common femoral endovenectomy and intraoperative endoluminal recanalization of the iliac veins in patients with incapacitating postthrombotic iliofemoral obstruction. METHODS: Ten patients underwent common femoral endovenectomy with endoluminal iliocaval recanalization. The Venous Clinical Severity Score (VCSS), a validated tool to assess chronic venous disease, the Villalta scale, a validated tool to quantify postthrombotic syndrome, the clinical classification of CEAP, and the Venous Insufficiency Epidemiological and Economic Study-Quality of Life (VEINES-QOL)/Sym questionnaires were completed preoperatively and readministered postoperatively at 8.8 months (mean). RESULTS: Five patients were followed for more than 6 months and form the basis of the long-term analysis. All demonstrated significant improvement in their venous scores postoperatively. The VCSS preoperatively was 17 and fell to 9.8 postoperatively (P = .02). The Villalta scale dropped from 13.6 preoperatively to 6.0 postoperatively (P = .002). The VEINES-QOL/Sym questionnaire, a sensitive marker of patient quality of life and symptom status, was improved (P = .01 and .02, respectively). CONCLUSION: Chronic postthrombotic iliofemoral venous obstruction treated with common femoral endovenectomy and endoluminal recanalization improves objective outcome measures of patients with chronic postthrombotic obstruction. By restoring unobstructed venous drainage through the CFV to the vena cava, patients' postthrombotic morbidity is reduced and quality of life is improved.


Subject(s)
Catheterization , Femoral Vein/surgery , Iliac Vein/surgery , Postthrombotic Syndrome/therapy , Quality of Life , Vascular Surgical Procedures , Catheterization/adverse effects , Catheterization/instrumentation , Chronic Disease , Combined Modality Therapy , Constriction, Pathologic , Femoral Vein/diagnostic imaging , Femoral Vein/physiopathology , Humans , Iliac Vein/diagnostic imaging , Iliac Vein/physiopathology , Ohio , Phlebography , Postthrombotic Syndrome/diagnosis , Postthrombotic Syndrome/physiopathology , Postthrombotic Syndrome/psychology , Severity of Illness Index , Stents , Surveys and Questionnaires , Time Factors , Treatment Outcome , Vascular Patency , Vascular Surgical Procedures/adverse effects
5.
J Vasc Surg ; 55(3): 768-73, 2012 Mar.
Article in English | MEDLINE | ID: mdl-22277690

ABSTRACT

BACKGROUND: Iliofemoral deep vein thrombosis (DVT) is associated with severe postthrombotic morbidity when treated with anticoagulation alone. Catheter-directed thrombolysis (CDT), with or without the addition of mechanical techniques, is increasingly recommended for patients with iliofemoral DVT, although its effect on postthrombotic syndrome is not established. This study examined the correlation of residual thrombus with postthrombotic syndrome after catheter-based attempts at thrombus removal in patients with iliofemoral DVT. METHODS: Seventy-one consecutive patients with iliofemoral DVT were treated with CDT. Pretreatment and posttreatment phlebograms were evaluated for quantity of residual thrombus by physicians blinded to clinical patient outcomes. Postthrombotic syndrome was assessed using CEAP and Villalta scores by examiners blinded to phlebographic results. Patients were grouped by the amount of residual thrombus in treated vein segments (group 1, ≤50%; group 2, >50%). Clinical score and postthrombotic outcomes were plotted vs residual thrombus. RESULTS: Sixty-three of 71 patients completed CEAP and Villalta analyses. Groups 1 and 2 had median CEAP scores of 1 and 4 (P = .025) and mean Villalta scores of 2.21 and 7.13, respectively (P = .011). There was a direct and significant correlation of clinical class of CEAP with residual thrombus (R(2) = .74; P = .004) and a direct linear correlation of Villalta score with residual thrombus (R(2) = .61; P = .0014). CONCLUSIONS: In patients with iliofemoral DVT treated with catheter-based techniques of thrombus removal, postthrombotic morbidity is related to residual thrombus. When thrombus clearance was complete, the postthrombotic syndrome was avoided. Residual thrombus is associated with an increasing risk of postthrombotic syndrome.


Subject(s)
Catheterization , Femoral Vein , Fibrinolytic Agents/administration & dosage , Iliac Vein , Mechanical Thrombolysis , Postthrombotic Syndrome/etiology , Thrombolytic Therapy , Venous Thrombosis/therapy , Catheterization/adverse effects , Female , Femoral Vein/diagnostic imaging , Fibrinolytic Agents/adverse effects , Humans , Iliac Vein/diagnostic imaging , Linear Models , Male , Mechanical Thrombolysis/adverse effects , Middle Aged , Ohio , Phlebography , Postthrombotic Syndrome/diagnostic imaging , Postthrombotic Syndrome/prevention & control , Predictive Value of Tests , Retrospective Studies , Risk Assessment , Risk Factors , Thrombolytic Therapy/adverse effects , Time Factors , Treatment Outcome , Venous Thrombosis/complications , Venous Thrombosis/diagnostic imaging
6.
J Vasc Surg Venous Lymphat Disord ; 7(1): 65-73, 2019 01.
Article in English | MEDLINE | ID: mdl-30558731

ABSTRACT

OBJECTIVE: Chronic, post-thrombotic iliofemoral and inferior vena caval obstruction is associated with debilitating morbidity. Venoplasty and stenting are often successful; however, in the presence of a diseased or occluded common femoral vein (CFV), failure is common. A hybrid operative procedure of open surgical CFV endovenectomy and endoluminal recanalization or bypass of the obstructed iliofemoral and vena caval segments has been developed and modified. The purpose of this report was to assess the technical evolution of this procedure on operative complications. METHODS: Thirty-one patients undergoing CFV endovenectomy and proximal ipsilateral endoluminal reconstruction (iliac, inferior vena caval) or contralateral outflow were analyzed. The initial techniques of patient management were compared with the present contemporary techniques, evaluating procedural complications and failures. The contemporary procedure evolved to include routine axial imaging, preoperative venography through the popliteal vein, preoperative passage of a guidewire or catheter into the patent vena cava, placement of an ipsilateral popliteal vein sheath for intraoperative and postoperative anticoagulation, routine patch closure, routine arteriovenous fistulas, routine completion intravascular ultrasound, and long-term anticoagulation with warfarin to a target international normalized ratio of 3.0 to 4.0. Procedure-related complications were compared between the initial and contemporary techniques. RESULTS: Of 17 patients treated with the early techniques, 15 (88%) had major complications: 5 iliofemoral thromboses, 4 major wound bleeds, 4 wound infections, and 2 CFV stenoses requiring reintervention. One iliac vein rupture treated with a stent graft thrombosed. Of 14 patients treated with the contemporary techniques, 2 (14%; P = .006) had major complications: 1 bleed and 1 infected seroma. One intraoperative iliac vein rupture, treated with a second stent relining the first, remains patent. CONCLUSIONS: Contemporary hybrid operative techniques for incapacitating post-thrombotic iliofemoral and vena caval obstruction increase procedural success and reduce complications compared with the initial approach. The contemporary techniques are recommended for patients undergoing hybrid operative management of post-thrombotic iliofemoral and vena caval occlusion involving the CFV.


Subject(s)
Blood Vessel Prosthesis Implantation , Endovascular Procedures , Iliac Vein/surgery , Postthrombotic Syndrome/surgery , Vena Cava, Inferior/surgery , Adolescent , Adult , Aged , Anticoagulants/therapeutic use , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/instrumentation , Chronic Disease , Combined Modality Therapy , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Female , Humans , Iliac Vein/diagnostic imaging , Iliac Vein/physiopathology , Male , Middle Aged , Postoperative Complications/therapy , Postthrombotic Syndrome/diagnostic imaging , Postthrombotic Syndrome/physiopathology , Retrospective Studies , Risk Factors , Time Factors , Treatment Outcome , Vascular Patency , Vena Cava, Inferior/diagnostic imaging , Vena Cava, Inferior/physiopathology , Young Adult
7.
Am Surg ; 83(2): 148-156, 2017 Feb 01.
Article in English | MEDLINE | ID: mdl-28228201

ABSTRACT

We report the experience of a Level I trauma center in the management of blunt renal injury during a 5-year period, with special attention to those treated using angiography with embolization. The institutional trauma registry was queried for all patients with blunt renal injury between September 1, 2009 and August 30, 2014. Each injury was graded using the American Association for the Surgery of Trauma guidelines. Patients that underwent angiography with embolization were reviewed for case-specific information including imaging findings, treatment, materials used, clinical course, and mortality. The registry identified 48 blunt renal injury patients. Median Injury Severity Score was higher and hospital length of stay was significantly longer in those with blunt renal injury when compared with those without blunt renal injury (P < 0.001). The majority of patients with blunt renal injury were managed nonoperatively. Mortality was three out of 48 patients (5%). Nine patients underwent exploratory laparotomy. These operations were always performed for reasons other than the renal trauma (e.g., splenic injury, free fluid, free air). No patient underwent invasive renal operation. Six patients were treated using angiography with embolization. Of the six, one patient died of pulmonary septic complications. We conclude that selective nonoperative management is the mainstay of treatment for blunt renal injury. Angiography with embolization is a useful modality for cases of ongoing bleeding, and is typically preferable to nephrectomy in our experience.


Subject(s)
Embolization, Therapeutic , Kidney/injuries , Wounds, Nonpenetrating/therapy , Adolescent , Adult , Aged , Aged, 80 and over , Angiography , Female , Humans , Injury Severity Score , Kidney/blood supply , Kidney/diagnostic imaging , Laparotomy/statistics & numerical data , Length of Stay , Male , Middle Aged , Primary Health Care , Registries/statistics & numerical data , Retrospective Studies , Trauma Centers , Wounds, Nonpenetrating/complications , Wounds, Nonpenetrating/diagnostic imaging , Wounds, Nonpenetrating/mortality , Young Adult
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