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Percutaneous vacuum assisted thrombectomy using AngioVac aspiration system
CARREV-01782; No of Pages 5 Cardiovascular Revascularization Medicine xxx (xxxx) xxx
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Cardiovascular Revascularization Medicine
Percutaneous vacuum assisted thrombectomy using AngioVac aspiration system Furqan A. Rajput a,⁎, Lianlian Du b, Michael Woods c, Kurt Jacobson d a
Department of Medicine, University of Wisconsin-Madison, Madison, WI, United States of America Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison, Madison, WI, United States of America Department of Radiology, University of Wisconsin-Madison, Madison, WI, United States of America d Cardiovascular Medicine, University of Wisconsin-Madison, Madison, WI, United States of America b c
a r t i c l e
i n f o
Article history: Received 14 October 2019 Received in revised form 3 December 2019 Accepted 16 December 2019 Available online xxxx Keywords: Percutaneous thrombectomy Mechanical thrombectomy AngioVac Intracardiac thrombi Pulmonary embolism
a b s t r a c t Background: Surgical embolectomy and thrombolytic therapy are two common approaches for the treatment of large intra-cardiac or intravascular thrombi to prevent new or worsening pulmonary embolism (PE). Considering high operative mortality with surgical embolectomy and high bleeding risk with thrombolytic therapy, patients who are poor candidates for these treatments may benefit from percutaneous aspiration thrombectomy/ Vacuum-assisted thrombectomy (VAT). AngioVac aspiration system was granted 510(k) clearance by the United States Food and Drug Administration (FDA) in April 2009. We present a case series to describe its use and outcomes in evacuating large caval thrombi or intracardiac masses. Methods: We did a retrospective analysis of AngioVac catheter based thrombectomy in 16 consecutive patients treated between January 2016 and January 2019 to report case characteristics and in-hospital clinical outcomes. Results: Sixteen patients (mean age 48) underwent 16 AngioVac procedures over 48 months. Indications included intracardiac mass (68.8%), caval thrombus (56.3%), and catheter associated thrombus (43.8%). 7 (43.8%) patients had concurrent PE. Peri-procedure mortality was 0% and in-hospital mortality was 12.5% at a mean follow-up of 14 days. There were no pulmonary hemorrhages, strokes or myocardial infarctions. 62.5% had a significant drop in hemoglobin, which required a blood transfusion but there was no episode of overt bleeding. Conclusion: The AngioVac aspiration system has been shown to be effective at aspirating large volumes of intravascular and intracardiac thrombus. It is a reasonable alternative to surgical thrombectomy in patients with large central thrombi or masses in-transit who are at risk of complicated PE. © 2019 Elsevier Inc. All rights reserved.
1. Introduction Venous thromboembolism (VTE), which includes both deep venous thrombosis (DVT) and pulmonary embolism (PE), affects over a million Americans every year [1]. Right heart thrombi, although seen in only 4% of PE, are arduous to manage since they are a predictor of cardiac arrest and are associated with devastatingly high mortality in untreated patients [2–6]. There is a lack of consensus regarding the optimal management of right heart thrombus [7]. Even less well known is how to manage patients without concurrent PE who have large clots in transit. There is agreement however to recognize it as a therapeutic emergency and avoid delays in treatment to reduce mortality [2,8,9]. ⁎ Corresponding author at: Department of Medicine, Division of Hospital Medicine, University of Wisconsin-Madison, School of Medicine & Public Health, 600 Highland Avenue, Madison, WI, United States of America. E-mail address: [email protected] (F.A. Rajput).
In addition to anticoagulation, surgical embolectomy and thrombolytic therapy are two well-described approaches for the treatment of large intra-cardiac or intravascular thrombi to prevent new or worsening pulmonary embolism [10,11]. Surgical embolectomy can be challenging in critically ill patients with operative mortality of 10% in unstable patients and 3.6% in stable patients with pulmonary embolism [12]. Thrombolytics can be effective in treating PE and while noninvasive are associated with a 9–11% major bleeding risk and ~2% risk of intracranial bleeding in contemporary trials [13]. Percutaneous aspiration thrombectomy/Vacuum-assisted thrombectomy (VAT) may benefit patients with concurrent PE or to prevent significant PE who have extensive iliocaval thrombus or intra-cardiac mass in transit who are poor candidates for thrombolytic therapy or surgical thromboembolectomy. The United States Food and Drug Administration (FDA) granted 510 (k) clearance to AngioVac aspiration system in 2009 for en bloc removal of intravascular material such as thrombus, tumor, foreign bodies, and vegetation through veno-venous extracorporeal bypass circuit [14].
https://doi.org/10.1016/j.carrev.2019.12.020 1553-8389/© 2019 Elsevier Inc. All rights reserved.
Please cite this article as: F.A. Rajput, L. Du, M. Woods, et al., Percutaneous vacuum assisted thrombectomy using AngioVac aspiration system, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.12.020
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Several studies have since reported the effectiveness of percutaneous aspiration thrombectomy in removing right atrial masses [11,15–17]. In this report, we present a retrospective analysis of patients who have undergone AngioVac catheter procedure in terms of their clinical characteristics, indication for procedures and in-hospital clinical outcomes. 2. Materials and methods 2.1. Study population All cases in which AngioVac catheter was used for a variety of indications at University of Wisconsin (UW) Madison Hospital between January 2016 and January 2019 were reviewed. The institutional review board and University of Wisconsin approved the study. UW Institute for clinical and translational research (ICTR) and the clinical research data service (CRDS) identified patients using current procedural terminology (CPT) code. Retrospective data including demographics, past medical history, clinical presentation, indication for procedure, and inhospital outcomes were collected from electronic health records. 2.2. Statistical analysis Results are presented as mean ± standard deviation (SD) for quantitative variables and summarized by absolute frequencies and percentages for categorical variables.
Table 2 Pertinent procedure related variables (N = 16). Variables Indication Right atrial mass Right ventricular mass Catheter-associated thrombus Deep venous thrombosis involving vena cava Concurrent pulmonary embolism Clot size (cm) Requiring vasopressor therapy before the procedure Concomitant catheter directed tPA Thrombectomy success Complete Partial Unsuccessful Bleeding Post procedure hematocrit drop (no action) Post procedure transfusion without overt bleeding Overt bleeding (transfusion needed) Hematoma Pulmonary hemorrhage Myocardial infarction Stroke Shock Liver failure Hemodialysis Creatinine (mg/dl) Pre procedure Post procedure peak Length of hospitalization after procedure Survival to discharge
N (%)/mean (SD) 11 (68.8%) 0 7 (43.8%) 9 (56.3%) 7 (43.8%) 4.1 ± 2.6 4 (25%) 3 (18.8%) 13 (81.3%) 2 (12.5%) 1 (6.3%) 6 (37.5%) 10 (62.5%) 0 0 0 0 0 1 (6.3%) 0 2 (12.5%) 1.2 ± 1.0 1.5 ± 1.6 13.82 ± 13.8 14 (87.5%)
3. Results AngioVac aspiration system was used in 16 patients from January 2016 and January 2019 at our institution. Table 1 shows the baseline clinical characteristics of all the patients in the study; mean age 48 years and 75% females. None of the patients had a history of thrombophilia. Indications included right-sided intracardiac mass (68.8%), catheter-associated thrombus (43.8%), and caval thrombus (56.3%); see Table 2. Overlap in numbers is due to extension of caval or catheter-associated thrombus into the right atrium in some patients. Of the 16 patients, 7 (43.8%) patients had concurrent PE. 25% patients required vasopressor therapy before the start of procedure due to hypotension. 81.3% of the patients underwent complete thrombus extraction or obtained the desired result. Majority (75%) of the material extracted was found to be sterile thrombus on pathological examination. 57% (4/ 7) of catheter associated vegetation were found to be infective with positive cultures. 18.8% (n = 3) required concomitant catheter direct thrombolysis. None of the patients received systemic thrombolysis. Pulmonary trunk or pulmonary arteries were not intervened using AngioVac catheter in any of the patients.
Table 1 Clinical characteristics of study population (N = 16). Variables
N (%)/mean (SD)
Age (years) Female (n) Medical history Prior venous thromboembolism Thrombophilia Chronic obstructive pulmonary disease Coronary artery disease Chronic heart failure Cerebrovascular disease Patent foramen ovale or atrial septal defect Diabetes Hypertension Chronic kidney disease Chronic immunosuppressive therapy Active malignancy
47.8 ± 16.4 12 (75.0%) 3 (18.8%) 0 1 (6.3%) 2 (12.5%) 6 (37.5%) 1 (6.3%) 0 9 (56.3%) 6 (37.5%) 4 (25.0%) 4 (25.0%) 4 (25.0%)
Mean hospital stay after the procedure was 13 days with 87.5% (n = 14) survival at the time of discharge. All patients had a reduction in hemoglobin after the procedure; more than half (62.5%) of these patients required blood transfusion due to baseline anemia and anticipated blood loss in the extracorporeal circuit. None of the patients had an episode of overt bleeding including access site complications, non-access bleeding, or pulmonary hemorrhage. Complications including cardiac perforation or structural damage were not identified in any of the patients on post procedure echocardiography. No venous or access site complications were observed with AngioVac catheter use. Access site closure was successful using a combination of pre-closure technique using Abbott Perclose Proglide Vascular closure devices or Figure-8 suture technique. Out of the two patients who received hemodialysis, one had a history of end stage renal disease and was on scheduled hemodialysis three times a week. The other patient was a young female with Turner syndrome, atrioventricular canal defect, severe cardiomyopathy for which she had orthotopic heart transplant a month before the percutaneous thrombectomy for concerns of infected right atrial mass. At the time of procedure, she was being treated with vasopressors for septic shock and continuous veno-venous hemodialysis for acute kidney injury. 4. Discussion AngioVac aspiration system consists of a 22F suction cannula, an extracorporeal circuit with a filter, and a reinfusion catheter for blood return to the patient (Fig. 1). The large bore suction cannula has an expandable, funnel-shaped distal tip to enhance the blood flow. It filters the removed blood of any undesired material such as thrombus, tumor, foreign bodies, and vegetation in the bypass circuit and delivers it back to the circulation without causing hemolysis. We report case characteristics and clinical outcomes of AngioVac aspiration system use in patients at our institution. Large PE (blockage of N50% pulmonary artery cross-sectional area) results in hemodynamic compromise due to the acute need to generate high systolic pressure by the right ventricle, which
Please cite this article as: F.A. Rajput, L. Du, M. Woods, et al., Percutaneous vacuum assisted thrombectomy using AngioVac aspiration system, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.12.020
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Fig. 1. AngioVac aspiration system. (Reproduced with permission from AngioDynamics, Latham, NY.)
leads to its failure [18,19]. Right heart thrombus presents an even higher risk of right heart failure and death in patients with PE. They either form in situ due to atrial fibrillation, intracardiac foreign bodies such as pacemaker leads, lines/catheters and prosthetic valves or represent emboli dislodged from deep venous thrombi (right heart thrombus in transit). Mortality as high as 23–29% has been reported in patients treated with heparin alone, compared to thrombolysis (11%) and embolectomy (24%) [3,4]. This is much higher than 3 to 15% in-patient mortality reported in patients with PE alone [20]. Thus, surgical intervention is often considered in patients with right heart thrombus with or without iliocaval thrombosis or
concurrent PE. Also, anticoagulation when supplemented with surgical embolectomy or systemic thrombolysis has been shown to reverse right ventricular failure and cardiogenic shock in patients with massive PE [21,22]. Because of the significant morbidity associated with embolectomy and contraindications to thrombolysis, one third of the patients are ineligible to receive either of these treatment options [23,24]. These patients can benefit from the advent of innovative, less invasive, catheter-based percutaneous aspiration thrombectomy/vacuum-assisted thrombectomy (VAT) for removal of undesired intravascular material including thrombus and tumor (Fig. 2).
Please cite this article as: F.A. Rajput, L. Du, M. Woods, et al., Percutaneous vacuum assisted thrombectomy using AngioVac aspiration system, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.12.020
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Fig. 2. AngioVac assisted removal of right heart thrombus in transit. (a) Echocardiographic appearance of right atrial thrombus in transit. (b) Echocardiographic appearance of right atrial thrombus in transit being removed using AngioVac catheter. (c) 8.5 cm clot-in-transit suctioned en-bloc using AngioVac aspiration system. (d) Post-procedure echocardiographic image of the right atrium.
Tools to achieve catheter-based thrombectomy by various methods including aspiration, fragmentation, and extraction have been developed in the past but the need for concurrent thrombolytic therapy has limited their use [25–27]. The AngioVac (AngioDynamics, Latham, NY) aspiration system removes large volume of thrombus and unwanted material without hemodynamic compromise or the need for concomitant use of thrombolytic therapy. Although extracorporeal circuit does require heparin, it provides an alternative option to patients who are too ill to undergo surgery or have contraindications to thrombolysis. This report describes the use of AngioVac aspiration system for a wide variety of indications including implantable cardiac lead vegetation, iliocaval thrombi, and intracardiac clot thrombi. Our study population has in-hospital mortality of just 12.5% (n = 2) despite the high degree of acuity, large clot burden and a quarter of patients on vasopressor therapy before the procedure. In similar patients with hemodynamic compromise, who are not appropriate for open embolectomy or thrombolytic therapy, percutaneous aspiration thrombectomy is an important tool to be considered. Majority of the patients underwent complete VAT using AngioVac catheter with only one unsuccessful attempt. Success rate is similar to what has been reported in other studies [28]. Although there have been reports of its off-label use for pulmonary artery thrombectomy, it was not attempted in our study. We hope that future modifications in the size and flexibility of the cannula will enable to extract clots from main pulmonary artery. Fibrin thrombus, which is deposited on permanent pacemaker leads, later evolves into endothelium-covered tissue composed of cells and collagen. It can become colonized with bacteria leading to catheter-related infections [29,30]. Generally, the treatment of implantable cardioverter defibrillator (ICD) and pacemaker lead infections entails removal of
hardware, prolonged course of antibiotics, and may require surgical excision of large fibrin sheets [31]. Todoran et al. reported extraction of 1.7 cm mobile fibrin sheet vegetation at the junction of superior vena ceva and right atrium after ICD extraction using AngioVac system [11]. In our study, 7 patients underwent VAT for catheter-associated thrombus with 100% success rate. The largest thrombus extracted was 8 cm with 57% of them infected on subsequent laboratory testing. The AngioVac aspiration system (cannula with an extracorporeal bypass circuit running) is designed to be used for up to 6 h. Duration of use in all cases in our study was b3 h. Patients remained hemodynamically stable during AngioVac thrombectomy despite 4 l/min of veno-venous recirculation. Three patients were on vasopressor therapy before the start of procedure; none of the patients needed initiation during or after the procedure. The most common complication was postprocedure drop in hemoglobin, which may be because of the volume of blood that remains in the circuit after the procedure. None of the patients had evidence of overt bleeding or pulmonary hemorrhage. In addition to most commonly reported side effect of bleeding, which includes overt bleeding, localized hematoma, pulmonary hemorrhage, and drop in hemoglobin requiring blood transfusion; balloon rupture of the cannula tip, right ventricular free wall perforation and embolization to pulmonary arteries causing cardiopulmonary collapse has also been described in literature [28,32–36]. Two patients who died were critically ill, underwent successful VAT and did not die of procedure related complications. One developed disseminated intravascular coagulation (DIC), septic shock, and acute kidney injury needing vasopressor therapy and continuous veno-venous hemodialysis. She was clearly not suitable for surgical thrombectomy or thrombolysis but underwent successful percutaneous aspiration thrombectomy of right atrial mass. She died of complications related
Please cite this article as: F.A. Rajput, L. Du, M. Woods, et al., Percutaneous vacuum assisted thrombectomy using AngioVac aspiration system, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.12.020
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to recently transplanted heart, multi organ failure and shock. For the other patient, goals of care were care changed to comfort measures only due to multiple end stage co-morbid conditions. On a cost basis AngioVac thrombectomy is more expensive compared to some other endovascular options for treatment of venous thrombi or use of intravenous Alteplase. However, not requiring angiography suite follow up and ICU level of care monitoring for potential bleeding complications during thrombolysis compensate its cost. Despite its costs, the less invasive nature and successful clinical outcomes may make it a more suitable option especially for patients with contraindications to surgical embolectomy and thrombolysis. Previously, large size and rigidity of the device made it challenging to manipulate it around tight curves and intravascular space. Newer generation cannula with a flexible 20-degree or a 180-degree angled tip enables easier navigation particularly for intracardiac masses. Even with the recent improvement in design, adequate experience and superior technical expertise is required to avoid complications related to its use. Despite the limitation of retrospective design, small sample size, and single center experience, this study contributes to a very limited pool of similar studies in reporting the indications, clinical use and outcomes of AngioVac catheter use. 5. Conclusion The AngioVac aspiration system has been shown to be effective at aspirating large volumes of intravascular and intracardiac thrombus. It has emerged as a treatment option for large iliocaval thrombus, catheter-associated thrombus, and intracardiac thrombus in patients who are not suitable to undergo surgical embolectomy or have contraindication to thrombolytic therapy when anticoagulation alone may be inadequate. Credit author statement Furqan A. Rajput: Formal analysis, Investigation, Data Curation, Writing - original draft. Lianlian Du: Formal analysis. Michael Woods: Conceptualization, Methodology, and Supervision. Kurt Jacobson: Conceptualization, Methodology, Writing - review & editing, Supervision, and Project administration. Declaration of competing interest None. References [1] Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, et al. Heart Disease and Stroke Statistics-2019 update: a report from the American Heart Association. Circulation 2019;139:e56–528. https://doi.org/10.1161/CIR.0000000000000659. [2] Chartier L, Bera J, Delomez M, Asseman P, Beregi JP, Bauchart JJ, et al. Free-floating thrombi in the right heart: diagnosis, management, and prognostic indexes in 38 consecutive patients. Circulation 1999;99:2779–83. https://doi.org/10.1161/01.cir. 99.21.2779. [3] Rose PS, Punjabi NM, Pearse DB. Treatment of right heart thromboemboli. Chest 2002;121:806–14. [4] Torbicki A, Galie N, Covezzoli A, Rossi E, De Rosa M, Goldhaber SZ, et al. Right heart thrombi in pulmonary embolism: results from the International Cooperative Pulmonary Embolism Registry. J Am Coll Cardiol 2003;41:2245–51. [5] Carson JL, Kelley MA, Duff A, Weg JG, Fulkerson WJ, Palevsky HI, et al. The clinical course of pulmonary embolism. N Engl J Med 1992;326:1240–5. https://doi.org/ 10.1056/NEJM199205073261902. [6] Kinney EL, Wright RJ. Efficacy of treatment of patients with echocardiographically detected right-sided heart thrombi: a meta-analysis. Am Heart J 1989;118:569–73. https://doi.org/10.1016/0002-8703(89)90274-3. [7] Otoupalova E, Dalal B, Renard B. Right heart thrombus in transit: a series of two cases. Crit Ultrasound J 2017;9(14). https://doi.org/10.1186/s13089-017-0069-9. [8] Athappan G, Sengodan P, Chacko P, Gandhi S. Comparative efficacy of different modalities for treatment of right heart thrombi in transit: a pooled analysis. Vasc Med 2015;20:131–8. https://doi.org/10.1177/1358863X15569009. [9] Cosgrove H, Hyland-McGuire P. Right heart thrombus: the importance of early intervention. J Accid Emerg Med 1999;16:291–2. https://doi.org/10.1136/emj.16.4.291.
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Please cite this article as: F.A. Rajput, L. Du, M. Woods, et al., Percutaneous vacuum assisted thrombectomy using AngioVac aspiration system, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.12.020
Contents lists available at ScienceDirect
Cardiovascular Revascularization Medicine
Percutaneous vacuum assisted thrombectomy using AngioVac aspiration system Furqan A. Rajput a,⁎, Lianlian Du b, Michael Woods c, Kurt Jacobson d a
Department of Medicine, University of Wisconsin-Madison, Madison, WI, United States of America Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison, Madison, WI, United States of America Department of Radiology, University of Wisconsin-Madison, Madison, WI, United States of America d Cardiovascular Medicine, University of Wisconsin-Madison, Madison, WI, United States of America b c
a r t i c l e
i n f o
Article history: Received 14 October 2019 Received in revised form 3 December 2019 Accepted 16 December 2019 Available online xxxx Keywords: Percutaneous thrombectomy Mechanical thrombectomy AngioVac Intracardiac thrombi Pulmonary embolism
a b s t r a c t Background: Surgical embolectomy and thrombolytic therapy are two common approaches for the treatment of large intra-cardiac or intravascular thrombi to prevent new or worsening pulmonary embolism (PE). Considering high operative mortality with surgical embolectomy and high bleeding risk with thrombolytic therapy, patients who are poor candidates for these treatments may benefit from percutaneous aspiration thrombectomy/ Vacuum-assisted thrombectomy (VAT). AngioVac aspiration system was granted 510(k) clearance by the United States Food and Drug Administration (FDA) in April 2009. We present a case series to describe its use and outcomes in evacuating large caval thrombi or intracardiac masses. Methods: We did a retrospective analysis of AngioVac catheter based thrombectomy in 16 consecutive patients treated between January 2016 and January 2019 to report case characteristics and in-hospital clinical outcomes. Results: Sixteen patients (mean age 48) underwent 16 AngioVac procedures over 48 months. Indications included intracardiac mass (68.8%), caval thrombus (56.3%), and catheter associated thrombus (43.8%). 7 (43.8%) patients had concurrent PE. Peri-procedure mortality was 0% and in-hospital mortality was 12.5% at a mean follow-up of 14 days. There were no pulmonary hemorrhages, strokes or myocardial infarctions. 62.5% had a significant drop in hemoglobin, which required a blood transfusion but there was no episode of overt bleeding. Conclusion: The AngioVac aspiration system has been shown to be effective at aspirating large volumes of intravascular and intracardiac thrombus. It is a reasonable alternative to surgical thrombectomy in patients with large central thrombi or masses in-transit who are at risk of complicated PE. © 2019 Elsevier Inc. All rights reserved.
1. Introduction Venous thromboembolism (VTE), which includes both deep venous thrombosis (DVT) and pulmonary embolism (PE), affects over a million Americans every year [1]. Right heart thrombi, although seen in only 4% of PE, are arduous to manage since they are a predictor of cardiac arrest and are associated with devastatingly high mortality in untreated patients [2–6]. There is a lack of consensus regarding the optimal management of right heart thrombus [7]. Even less well known is how to manage patients without concurrent PE who have large clots in transit. There is agreement however to recognize it as a therapeutic emergency and avoid delays in treatment to reduce mortality [2,8,9]. ⁎ Corresponding author at: Department of Medicine, Division of Hospital Medicine, University of Wisconsin-Madison, School of Medicine & Public Health, 600 Highland Avenue, Madison, WI, United States of America. E-mail address: [email protected] (F.A. Rajput).
In addition to anticoagulation, surgical embolectomy and thrombolytic therapy are two well-described approaches for the treatment of large intra-cardiac or intravascular thrombi to prevent new or worsening pulmonary embolism [10,11]. Surgical embolectomy can be challenging in critically ill patients with operative mortality of 10% in unstable patients and 3.6% in stable patients with pulmonary embolism [12]. Thrombolytics can be effective in treating PE and while noninvasive are associated with a 9–11% major bleeding risk and ~2% risk of intracranial bleeding in contemporary trials [13]. Percutaneous aspiration thrombectomy/Vacuum-assisted thrombectomy (VAT) may benefit patients with concurrent PE or to prevent significant PE who have extensive iliocaval thrombus or intra-cardiac mass in transit who are poor candidates for thrombolytic therapy or surgical thromboembolectomy. The United States Food and Drug Administration (FDA) granted 510 (k) clearance to AngioVac aspiration system in 2009 for en bloc removal of intravascular material such as thrombus, tumor, foreign bodies, and vegetation through veno-venous extracorporeal bypass circuit [14].
https://doi.org/10.1016/j.carrev.2019.12.020 1553-8389/© 2019 Elsevier Inc. All rights reserved.
Please cite this article as: F.A. Rajput, L. Du, M. Woods, et al., Percutaneous vacuum assisted thrombectomy using AngioVac aspiration system, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.12.020
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Several studies have since reported the effectiveness of percutaneous aspiration thrombectomy in removing right atrial masses [11,15–17]. In this report, we present a retrospective analysis of patients who have undergone AngioVac catheter procedure in terms of their clinical characteristics, indication for procedures and in-hospital clinical outcomes. 2. Materials and methods 2.1. Study population All cases in which AngioVac catheter was used for a variety of indications at University of Wisconsin (UW) Madison Hospital between January 2016 and January 2019 were reviewed. The institutional review board and University of Wisconsin approved the study. UW Institute for clinical and translational research (ICTR) and the clinical research data service (CRDS) identified patients using current procedural terminology (CPT) code. Retrospective data including demographics, past medical history, clinical presentation, indication for procedure, and inhospital outcomes were collected from electronic health records. 2.2. Statistical analysis Results are presented as mean ± standard deviation (SD) for quantitative variables and summarized by absolute frequencies and percentages for categorical variables.
Table 2 Pertinent procedure related variables (N = 16). Variables Indication Right atrial mass Right ventricular mass Catheter-associated thrombus Deep venous thrombosis involving vena cava Concurrent pulmonary embolism Clot size (cm) Requiring vasopressor therapy before the procedure Concomitant catheter directed tPA Thrombectomy success Complete Partial Unsuccessful Bleeding Post procedure hematocrit drop (no action) Post procedure transfusion without overt bleeding Overt bleeding (transfusion needed) Hematoma Pulmonary hemorrhage Myocardial infarction Stroke Shock Liver failure Hemodialysis Creatinine (mg/dl) Pre procedure Post procedure peak Length of hospitalization after procedure Survival to discharge
N (%)/mean (SD) 11 (68.8%) 0 7 (43.8%) 9 (56.3%) 7 (43.8%) 4.1 ± 2.6 4 (25%) 3 (18.8%) 13 (81.3%) 2 (12.5%) 1 (6.3%) 6 (37.5%) 10 (62.5%) 0 0 0 0 0 1 (6.3%) 0 2 (12.5%) 1.2 ± 1.0 1.5 ± 1.6 13.82 ± 13.8 14 (87.5%)
3. Results AngioVac aspiration system was used in 16 patients from January 2016 and January 2019 at our institution. Table 1 shows the baseline clinical characteristics of all the patients in the study; mean age 48 years and 75% females. None of the patients had a history of thrombophilia. Indications included right-sided intracardiac mass (68.8%), catheter-associated thrombus (43.8%), and caval thrombus (56.3%); see Table 2. Overlap in numbers is due to extension of caval or catheter-associated thrombus into the right atrium in some patients. Of the 16 patients, 7 (43.8%) patients had concurrent PE. 25% patients required vasopressor therapy before the start of procedure due to hypotension. 81.3% of the patients underwent complete thrombus extraction or obtained the desired result. Majority (75%) of the material extracted was found to be sterile thrombus on pathological examination. 57% (4/ 7) of catheter associated vegetation were found to be infective with positive cultures. 18.8% (n = 3) required concomitant catheter direct thrombolysis. None of the patients received systemic thrombolysis. Pulmonary trunk or pulmonary arteries were not intervened using AngioVac catheter in any of the patients.
Table 1 Clinical characteristics of study population (N = 16). Variables
N (%)/mean (SD)
Age (years) Female (n) Medical history Prior venous thromboembolism Thrombophilia Chronic obstructive pulmonary disease Coronary artery disease Chronic heart failure Cerebrovascular disease Patent foramen ovale or atrial septal defect Diabetes Hypertension Chronic kidney disease Chronic immunosuppressive therapy Active malignancy
47.8 ± 16.4 12 (75.0%) 3 (18.8%) 0 1 (6.3%) 2 (12.5%) 6 (37.5%) 1 (6.3%) 0 9 (56.3%) 6 (37.5%) 4 (25.0%) 4 (25.0%) 4 (25.0%)
Mean hospital stay after the procedure was 13 days with 87.5% (n = 14) survival at the time of discharge. All patients had a reduction in hemoglobin after the procedure; more than half (62.5%) of these patients required blood transfusion due to baseline anemia and anticipated blood loss in the extracorporeal circuit. None of the patients had an episode of overt bleeding including access site complications, non-access bleeding, or pulmonary hemorrhage. Complications including cardiac perforation or structural damage were not identified in any of the patients on post procedure echocardiography. No venous or access site complications were observed with AngioVac catheter use. Access site closure was successful using a combination of pre-closure technique using Abbott Perclose Proglide Vascular closure devices or Figure-8 suture technique. Out of the two patients who received hemodialysis, one had a history of end stage renal disease and was on scheduled hemodialysis three times a week. The other patient was a young female with Turner syndrome, atrioventricular canal defect, severe cardiomyopathy for which she had orthotopic heart transplant a month before the percutaneous thrombectomy for concerns of infected right atrial mass. At the time of procedure, she was being treated with vasopressors for septic shock and continuous veno-venous hemodialysis for acute kidney injury. 4. Discussion AngioVac aspiration system consists of a 22F suction cannula, an extracorporeal circuit with a filter, and a reinfusion catheter for blood return to the patient (Fig. 1). The large bore suction cannula has an expandable, funnel-shaped distal tip to enhance the blood flow. It filters the removed blood of any undesired material such as thrombus, tumor, foreign bodies, and vegetation in the bypass circuit and delivers it back to the circulation without causing hemolysis. We report case characteristics and clinical outcomes of AngioVac aspiration system use in patients at our institution. Large PE (blockage of N50% pulmonary artery cross-sectional area) results in hemodynamic compromise due to the acute need to generate high systolic pressure by the right ventricle, which
Please cite this article as: F.A. Rajput, L. Du, M. Woods, et al., Percutaneous vacuum assisted thrombectomy using AngioVac aspiration system, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.12.020
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Fig. 1. AngioVac aspiration system. (Reproduced with permission from AngioDynamics, Latham, NY.)
leads to its failure [18,19]. Right heart thrombus presents an even higher risk of right heart failure and death in patients with PE. They either form in situ due to atrial fibrillation, intracardiac foreign bodies such as pacemaker leads, lines/catheters and prosthetic valves or represent emboli dislodged from deep venous thrombi (right heart thrombus in transit). Mortality as high as 23–29% has been reported in patients treated with heparin alone, compared to thrombolysis (11%) and embolectomy (24%) [3,4]. This is much higher than 3 to 15% in-patient mortality reported in patients with PE alone [20]. Thus, surgical intervention is often considered in patients with right heart thrombus with or without iliocaval thrombosis or
concurrent PE. Also, anticoagulation when supplemented with surgical embolectomy or systemic thrombolysis has been shown to reverse right ventricular failure and cardiogenic shock in patients with massive PE [21,22]. Because of the significant morbidity associated with embolectomy and contraindications to thrombolysis, one third of the patients are ineligible to receive either of these treatment options [23,24]. These patients can benefit from the advent of innovative, less invasive, catheter-based percutaneous aspiration thrombectomy/vacuum-assisted thrombectomy (VAT) for removal of undesired intravascular material including thrombus and tumor (Fig. 2).
Please cite this article as: F.A. Rajput, L. Du, M. Woods, et al., Percutaneous vacuum assisted thrombectomy using AngioVac aspiration system, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.12.020
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Fig. 2. AngioVac assisted removal of right heart thrombus in transit. (a) Echocardiographic appearance of right atrial thrombus in transit. (b) Echocardiographic appearance of right atrial thrombus in transit being removed using AngioVac catheter. (c) 8.5 cm clot-in-transit suctioned en-bloc using AngioVac aspiration system. (d) Post-procedure echocardiographic image of the right atrium.
Tools to achieve catheter-based thrombectomy by various methods including aspiration, fragmentation, and extraction have been developed in the past but the need for concurrent thrombolytic therapy has limited their use [25–27]. The AngioVac (AngioDynamics, Latham, NY) aspiration system removes large volume of thrombus and unwanted material without hemodynamic compromise or the need for concomitant use of thrombolytic therapy. Although extracorporeal circuit does require heparin, it provides an alternative option to patients who are too ill to undergo surgery or have contraindications to thrombolysis. This report describes the use of AngioVac aspiration system for a wide variety of indications including implantable cardiac lead vegetation, iliocaval thrombi, and intracardiac clot thrombi. Our study population has in-hospital mortality of just 12.5% (n = 2) despite the high degree of acuity, large clot burden and a quarter of patients on vasopressor therapy before the procedure. In similar patients with hemodynamic compromise, who are not appropriate for open embolectomy or thrombolytic therapy, percutaneous aspiration thrombectomy is an important tool to be considered. Majority of the patients underwent complete VAT using AngioVac catheter with only one unsuccessful attempt. Success rate is similar to what has been reported in other studies [28]. Although there have been reports of its off-label use for pulmonary artery thrombectomy, it was not attempted in our study. We hope that future modifications in the size and flexibility of the cannula will enable to extract clots from main pulmonary artery. Fibrin thrombus, which is deposited on permanent pacemaker leads, later evolves into endothelium-covered tissue composed of cells and collagen. It can become colonized with bacteria leading to catheter-related infections [29,30]. Generally, the treatment of implantable cardioverter defibrillator (ICD) and pacemaker lead infections entails removal of
hardware, prolonged course of antibiotics, and may require surgical excision of large fibrin sheets [31]. Todoran et al. reported extraction of 1.7 cm mobile fibrin sheet vegetation at the junction of superior vena ceva and right atrium after ICD extraction using AngioVac system [11]. In our study, 7 patients underwent VAT for catheter-associated thrombus with 100% success rate. The largest thrombus extracted was 8 cm with 57% of them infected on subsequent laboratory testing. The AngioVac aspiration system (cannula with an extracorporeal bypass circuit running) is designed to be used for up to 6 h. Duration of use in all cases in our study was b3 h. Patients remained hemodynamically stable during AngioVac thrombectomy despite 4 l/min of veno-venous recirculation. Three patients were on vasopressor therapy before the start of procedure; none of the patients needed initiation during or after the procedure. The most common complication was postprocedure drop in hemoglobin, which may be because of the volume of blood that remains in the circuit after the procedure. None of the patients had evidence of overt bleeding or pulmonary hemorrhage. In addition to most commonly reported side effect of bleeding, which includes overt bleeding, localized hematoma, pulmonary hemorrhage, and drop in hemoglobin requiring blood transfusion; balloon rupture of the cannula tip, right ventricular free wall perforation and embolization to pulmonary arteries causing cardiopulmonary collapse has also been described in literature [28,32–36]. Two patients who died were critically ill, underwent successful VAT and did not die of procedure related complications. One developed disseminated intravascular coagulation (DIC), septic shock, and acute kidney injury needing vasopressor therapy and continuous veno-venous hemodialysis. She was clearly not suitable for surgical thrombectomy or thrombolysis but underwent successful percutaneous aspiration thrombectomy of right atrial mass. She died of complications related
Please cite this article as: F.A. Rajput, L. Du, M. Woods, et al., Percutaneous vacuum assisted thrombectomy using AngioVac aspiration system, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.12.020
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to recently transplanted heart, multi organ failure and shock. For the other patient, goals of care were care changed to comfort measures only due to multiple end stage co-morbid conditions. On a cost basis AngioVac thrombectomy is more expensive compared to some other endovascular options for treatment of venous thrombi or use of intravenous Alteplase. However, not requiring angiography suite follow up and ICU level of care monitoring for potential bleeding complications during thrombolysis compensate its cost. Despite its costs, the less invasive nature and successful clinical outcomes may make it a more suitable option especially for patients with contraindications to surgical embolectomy and thrombolysis. Previously, large size and rigidity of the device made it challenging to manipulate it around tight curves and intravascular space. Newer generation cannula with a flexible 20-degree or a 180-degree angled tip enables easier navigation particularly for intracardiac masses. Even with the recent improvement in design, adequate experience and superior technical expertise is required to avoid complications related to its use. Despite the limitation of retrospective design, small sample size, and single center experience, this study contributes to a very limited pool of similar studies in reporting the indications, clinical use and outcomes of AngioVac catheter use. 5. Conclusion The AngioVac aspiration system has been shown to be effective at aspirating large volumes of intravascular and intracardiac thrombus. It has emerged as a treatment option for large iliocaval thrombus, catheter-associated thrombus, and intracardiac thrombus in patients who are not suitable to undergo surgical embolectomy or have contraindication to thrombolytic therapy when anticoagulation alone may be inadequate. Credit author statement Furqan A. Rajput: Formal analysis, Investigation, Data Curation, Writing - original draft. Lianlian Du: Formal analysis. Michael Woods: Conceptualization, Methodology, and Supervision. Kurt Jacobson: Conceptualization, Methodology, Writing - review & editing, Supervision, and Project administration. Declaration of competing interest None. References [1] Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, et al. Heart Disease and Stroke Statistics-2019 update: a report from the American Heart Association. Circulation 2019;139:e56–528. https://doi.org/10.1161/CIR.0000000000000659. [2] Chartier L, Bera J, Delomez M, Asseman P, Beregi JP, Bauchart JJ, et al. Free-floating thrombi in the right heart: diagnosis, management, and prognostic indexes in 38 consecutive patients. Circulation 1999;99:2779–83. https://doi.org/10.1161/01.cir. 99.21.2779. [3] Rose PS, Punjabi NM, Pearse DB. Treatment of right heart thromboemboli. Chest 2002;121:806–14. [4] Torbicki A, Galie N, Covezzoli A, Rossi E, De Rosa M, Goldhaber SZ, et al. Right heart thrombi in pulmonary embolism: results from the International Cooperative Pulmonary Embolism Registry. J Am Coll Cardiol 2003;41:2245–51. [5] Carson JL, Kelley MA, Duff A, Weg JG, Fulkerson WJ, Palevsky HI, et al. The clinical course of pulmonary embolism. N Engl J Med 1992;326:1240–5. https://doi.org/ 10.1056/NEJM199205073261902. [6] Kinney EL, Wright RJ. Efficacy of treatment of patients with echocardiographically detected right-sided heart thrombi: a meta-analysis. Am Heart J 1989;118:569–73. https://doi.org/10.1016/0002-8703(89)90274-3. [7] Otoupalova E, Dalal B, Renard B. Right heart thrombus in transit: a series of two cases. Crit Ultrasound J 2017;9(14). https://doi.org/10.1186/s13089-017-0069-9. [8] Athappan G, Sengodan P, Chacko P, Gandhi S. Comparative efficacy of different modalities for treatment of right heart thrombi in transit: a pooled analysis. Vasc Med 2015;20:131–8. https://doi.org/10.1177/1358863X15569009. [9] Cosgrove H, Hyland-McGuire P. Right heart thrombus: the importance of early intervention. J Accid Emerg Med 1999;16:291–2. https://doi.org/10.1136/emj.16.4.291.
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Please cite this article as: F.A. Rajput, L. Du, M. Woods, et al., Percutaneous vacuum assisted thrombectomy using AngioVac aspiration system, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.12.020