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Ultrasound-guided thrombin injection versus ultrasound-guided compression therapy of iatrogenic femoral false aneurysms: Single center experience
medical journal armed forces india xxx (xxxx) xxx
Available online at www.sciencedirect.com
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Original Article
Ultrasound-guided thrombin injection versus ultrasound-guided compression therapy of iatrogenic femoral false aneurysms: Single center experience Mohammed A. Rashaideh a,*, Kristi E. Janho a, Jameel S. Shawaqfeh b, Eyad Ajarmeh a, Mohammed As'ad a a b
Vascular Surgery, King Hussin Medical Center, Amman, Jordan Radiology, King Hussin Medical Center, Amman, Jordan
article info
abstract
Article history:
Background: Iatrogenic femoral pseudoaneurysm (false aneurysm) due to arterial access
Received 20 May 2019
following cardiovascular procedures is becoming common because of the increase in
Accepted 24 September 2019
number and complexity of the procedures. Recently, percutaneous thrombin injection is
Available online xxx
becoming a popular treatment of these false aneurysms.
Keywords:
closure using ultrasound-guided thrombin injection in comparison to ultrasound-guided
False aneurysm
compression.
Pseudoaneurysm
Methods: A retrospective analysis was undertaken of 65 patients who presented to our
Iatrogenic compression
vascular department with iatrogenic femoral pseudoaneurysm between January 2015 and
Ultrasound-guided thrombin
March 2019. Twenty-five patients underwent ultrasound-guided thrombin injection, and 40
The aim of this study was to assess the efficacy and safety of femoral pseudoaneurysm
were treated using ultrasound-guided compression therapy. The primary outcome measured was efficacy, while other outcomes examined were safety, procedure duration, and cost. Results: A total of 65 patients (45 males, 20 female) were identified with a mean age of 62 years. Out of the 65, 40 patients (28 males, 12 female) underwent ultrasound-guided compression therapy (group A) with a mean aneurysm size of 2.9 cm, and 25 (17 male, 8 female) underwent ultrasound-guided thrombin injection (group B) with a mean pseudoaneurysm sac size of 3.7 cm. The success rate of thrombosis in group A was 70% and in group B was 92%. No significant complications were reported in both groups. Conclusions: Ultrasound-guided thrombin injection should be considered as the first line of treatment for uncomplicated femoral pseudoaneurysms because it has a higher thrombosis and lower recurrence rates, when compared with ultrasound-guided compression treatment. © 2019 Director General, Armed Forces Medical Services. Published by Elsevier, a division of RELX India Pvt. Ltd. All rights reserved.
* Corresponding author. E-mail address: [email protected] (M.A. Rashaideh). https://doi.org/10.1016/j.mjafi.2019.09.004 0377-1237/© 2019 Director General, Armed Forces Medical Services. Published by Elsevier, a division of RELX India Pvt. Ltd. All rights reserved. Please cite this article as: Rashaideh MA et al., Ultrasound-guided thrombin injection versus ultrasound-guided compression therapy of iatrogenic femoral false aneurysms: Single center experience, Medical Journal Armed Forces India, https://doi.org/10.1016/ j.mjafi.2019.09.004
2
medical journal armed forces india xxx (xxxx) xxx
Introduction Pseudoaneurysm (false aneurysm) is a contained pulsatile blood flow with disruption of all the vessel layers (intima, media, and adventitia) and surrounded by tissues.1 Femoral artery is the preferred site for access in the vast majority of diagnostic and therapeutic endovascular procedures (cardiac, aortic, and peripheral). The femoral artery false aneurysms incidence varies widely in the literature from 0.05% to 8.0%.2,3 The increasing number and complexity of the procedures in addition to the usage of potent antiplatelets and anticoagulants might be the cause of the increased frequency of the pseudoaneurysms. The preferred method for the diagnosis of iatrogenic femoral pseudoaneurysms is color Doppler ultrasound,4 with the ying-yang sign being pathognomonic (Fig. 1). By using ultrasound, many features of the pseudoaneurysm can be described as size, neck features, and vessel of origin.5 The management of all iatrogenic femoral pseudoaneurysms was surgical intervention. Although it is curative, surgery is associated with higher morbidity, mortality, and prolonged hospital stay. Nowadays, surgical repair is being reserved only for complicated pseudoaneurysms (compression symptoms, skin changes, rupture, limb ischemia, and short wide neck) and when other modalities fail to obliterate the aneurysm. Ultrasound-guided compression repair (UGCR) of femoral artery pseudoaneurysms was first described in 1991.6,7 This method was adopted by many physicians as a non-invasive successful alternative for surgery. Contraindications to compression include infection, skin ischemia, pressure symptoms on the nearby neurovascular structures, and severe pain.5,8 The success rates of UGCR were reported in the literature from 54% to 100%, and the predictors of success with UGCR are not well understood.5 In 1997, Liau et al. introduced ultrasound-guided percutaneous thrombin injection repair (UGTI) of iatrogenic pseudoaneurysms.9 The success rates for UGTI ranged from 91% to 100%, with a complication rate around 1.3%, including only 0.5% embolic events.10,11 Despite the potential complications, the advantages of UGTI include good patient tolerance, the high success rate, independency of procedure success on anticoagulation, and rapidity of the procedure. Some authors have even adopted UGTI as a standard of care for iatrogenic peripheral vascular pseudoaneurysms because of the high patient and physician satisfaction, ease of the procedure, and the low incidence of complications.5
clinical and the demographic data along with the treatment results was performed. The pseudoaneurysm sac and the neck characteristics along with the artery of origin were first identified using Doppler ultrasound, then continuous compression using the ultrasound probe was performed targeting the pseudoaneurysm neck to cease the flow inside the sac, while maintaining flow in the native artery. Re-evaluation of the color flow inside the sac at 10-min intervals was conducted. This technique was repeated until the pseudoaneurysm was totally thrombosed. Analgesia was given as required when there was unbearable pain during the procedure. The thrombin injection was done using aseptic technique with ultrasound guidance. The pseudoaneurysm features were first identified. Using the ultrasound B-mode, the most superficial entry point was marked. Then a 21-gauge spinal needle is advanced into the center of the sac away from the orifice, once back flow was noticed, a 5000 IU recombinant topical thrombin (Recothrom; ZymoGenetics Inc, Seattle, WA) reconstituted in 5 mL sterile saline was slowly injected with 100 IU at a time. The flow in the sac was continuously observed until complete thrombosis was achieved. Fig. 2. In both procedures, the nearby arteries and veins were imaged after completion to document their patency and were
Material and methods This study was approved by the ethical committee at our institution. The informed consent was waived because the data were analyzed retrospectively. The patients’ data were extracted from the vascular lab records at our department during the period of January 2015 to March 2019. A total of 65 patients were identified. All patients had iatrogenic femoral pseudoaneurysm diagnosed by Doppler ultrasound and were treated by compression or thrombin injection during same scanning session. Analysis of the
Fig. 1 e Color Doppler image showing femoral false aneurysm (yellow arrow) with the ying-yang sign, with the neck (black arrow) arising from the profunda femoral artery (PFA) (red arrow).
Please cite this article as: Rashaideh MA et al., Ultrasound-guided thrombin injection versus ultrasound-guided compression therapy of iatrogenic femoral false aneurysms: Single center experience, Medical Journal Armed Forces India, https://doi.org/10.1016/ j.mjafi.2019.09.004
3
medical journal armed forces india xxx (xxxx) xxx
compared with the baseline before the procedure. After successful thrombosis, the patient was kept supine with bed rest for 30 min. A follow-up ultrasound was obtained after 1 week for detection of recurrence.
Results In our institution, ultrasound-guided compression therapy of femoral pseudoaneurysms was the treatment of choice until February 2017, when this modality was replaced by ultrasound-guided thrombin injection. A retrospective analysis of the 40 patients (28 males, 12 females) with 40 pseudoaneurysms who underwent Ultrasound-Guided Compression Therapy ( UGCT) from January 2015 to February 2017 (group A) was conducted. The average age in this group was 60.7 years (range, 41e83 years). All the patients were on antiplatelets. The compression was overall successful in 28 patients (70%) including repeated compression in 5 patients. All pseudoaneurysms in this group were postcardiac catheterization. The average compression time was 36 min (range, 25e60 min). The average size of the false aneurysm in this group was 2.9 cm (range, 1.8e4.2 cm). Those patients with failed compression and persistent aneurysms underwent surgical repair. Analgesia during compression therapy was required in 14 (35%) patients. From February 2017 to March 2019, we managed 25 patients (17 males, 8 females) with 25 pseudoaneurysms using UGTI (group B). The average age in this group was 63.9 years (range, 52e81 years), and the average sac size was 3.7 cm (range, 2.5e5.4 cm). All patients were on antiplatelet therapy. The success rate of complete obliteration of the false aneurysms with thrombin injection was 92%. Twenty-four of the aneurysms were caused by cardiac catheterization, and one case was postperipheral angiography. Analgesia was not required in this group of patients. The mean duration from symptoms of the pseudoaneurysm and the institution of either treatment method was 4 days (1e14 days). All the patients of both groups were
Table 1 e Summary of the demographics of the patients with femoral pseudoaneurysms. Patient characteristics
Total
UGCT
UGTI
No. of patients Average age(year) Sex (M/F) Antiplatelets Anticoagulation Procedure Cardiac Peripheral Average pseudoaneurysm size
65 62 45/20 65 0
40 60.7 28/12 40 0
25 63.9 17/8 25 0
64 1 3.2
40 0 2.9
24 1 3.7
UGTI, ultrasound-guided percutaneous thrombin injection repair.
reviewed 1 week after the procedure, where a follow-up ultrasound was arranged. Pseudoaneurysms that did not show complete thrombosis on follow-up visit underwent second session of treatment. Open surgical repair was done after recurrent failure. No significant complications were reported in any of the patients in either group, apart from the discomfort and pain during handling of the pseudoaneurysm throughout ultrasound compression or injection. The average cost was calculated per patient for both groups and was $490 and $182 for compression and thrombin injection, respectively. The calculations were based on the vascular lab time, operation room time, and the cost of supplies. Tables 1 and 2 summarize the demographic features of the patients and the results of the treatment in both groups, respectively.
Discussion The incidence of femoral postcatheterization pseudoaneurysm has increased in the past years and was reported in many studies from 0.2% to 8.0%.2,3 Mostly, this wide range of incidence is attributed to the complexity of the procedures, vessel wall characteristics and to the use of potent antiplatelets and anticoagulants.
Fig. 2 e (a) Prethrombin injection: showing femoral false aneurysm (yellow arrow) arising from the common femoral artery. (b) Postthrombin injection: showing the same pseudoaneurysm with complete sac thrombosis (red arrow) with patent superficial femoral artery (SFA) and femoral vein (FV). Please cite this article as: Rashaideh MA et al., Ultrasound-guided thrombin injection versus ultrasound-guided compression therapy of iatrogenic femoral false aneurysms: Single center experience, Medical Journal Armed Forces India, https://doi.org/10.1016/ j.mjafi.2019.09.004
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Table 2 e Summary of the results of femoral pseudoaneurysm treatment using UGCT and UGTI. Procedure outcome
UGCT
UGTI
Success rate Average time to obliteration Average procedure time Complications Average cost $
70% 36 min 60 min 0 490
92% s 15 min 0 182
UGTI, ultrasound-guided percutaneous thrombin injection repair.
In our department, the diagnosis of all pseudoaneurysms was done in the vascular lab using color Doppler ultrasound. In all cases, the origin of the pseudoaneurysm was below the inguinal ligament except one case where the origin was from the distal external iliac artery. The treatment options we apply for femoral pseudoaneurysms include surgical repair, UGCT, UGTI and other rarely used methods such as coil embolization and covered stents. Surgical repair was conventionally applied for all pseudoaneurysms, but currently it is reserved for the complicated cases such as: compressive pseudoaneurysms, skin changes, associated arterio-venous fistula, and after failure of other modalities. These cases were excluded from our analysis because ultrasound-guided therapy was not attempted. Also, small aneurysms less than 1.5 cm diameter were treated conservatively and were excluded. Ultrasound-guided compression obliteration has become the first-line treatment of pseudoaneurysms at many institutions.12,13 It is considered to be safe, reproducible, and cost effective modality.14e17 However, it has some complications such as pain, failure, and recurrence, and it is considered to be a lengthy procedure which requires a great effort by the sonographer. Since 1991, many articles have been published assessing the efficacy and safety of UGCT. In the literature, the reported success rate with UGCT ranged from 54% to 100%.5 The etiology of treatment failure in the studies was variable, but the most frequent was the usage of anticoagulation and the large size of the sac.15e17 In our study, the UGCT was the preferred method until 2017. The total success rate in our series was 70%, counting five cases were thrombosed with repeated compression after 1 week. All patients who underwent UGCT were on antiplatelets therapy, but none was on anticoagulation. The average size of the sac in this group was 2.9 cm. Paulson et al. and Dean et al. reported a comparable success rates of 74% and 77%, respectively, with UGCT.16,18 However, higher success rates were reported by Coley et al., in which the occlusion rate was 93%.19 € rge et al. and Weinmann While in the studies done by G. Go et al., the success rates were 17% and 27%, respectively.20,21 The pseudoaneurysm size and anticoagulation both affect the success rate. In patients on anticoagulation, Eisenberg et al.22 and Coley et al.,19 experienced failure of the technique in 70% and 38% of patients, respectively compared with a failure rate of 26% and 5% in patients without anticoagulation. Coley et al.19 achieved a 100% success rate for small pseudoaneurysms of less than 2 cm in diameter and a 67% success rate for the sizes from 4 to 6 cm and further reduced success rate when the size was more than 6 cm.
Although, no major complications were reported in our series, complications such as pseudoaneurysm expansion or rupture, deep vein thrombosis (DVT), new onset cardiac events, and vasovagal attacks were reported in the literature as high as 3.4%.11,22 Despite the injection is an off-label use of topical thrombin, the UGTI has been frequently used since its introduction because of its high efficacy and safety. Although the success rates are very high, embolic and thrombotic complications were reported at a rate of 1.3% with only 0.5% embolic events.23 In this study, the success rate of UGTI was 92% with only two failed cases, both of them were large pseudoaneurysms of more than 5 cm in diameter and were injected with thrombin twice at different occasions. After the second failure, treatment with surgical repair deemed necessary. In our series with thrombin injection, all patients were on antiplatelets, but none was on anticoagulation, and there were no reported complications. Chen et al.24 reported in his series a primary success rate of 92%. According to Kreuger et al. and Vlachou et al.,25,26 higher failure rates of UGTI were reported in multilobed and large pseudoaneurysms. The anticoagulation status of the patients had not altered the UGTI success rate as reported by Chen et al.24 The procedure time and the total cost in our study were clearly obvious in favor of UGTI, which parallel the results in other studies.27,28 The average cost was calculated based on the procedure and vascular lab time in addition to the materials and operation room cost in cases when surgery was € nn et al. and Taylor et al., both reported that the needed. Lo calculated total cost was lower in the UGTI group.27,28 When reviewing the literature, there were many observational studies18,21,27,29 and few randomized controlled studies23,28 comparing UGCT with UGTI. In all these studies, the efficacy of UGTI was better with comparable complication rates. In a systematic review and meta-analysis of comparative studies between UGCT and UGTI, Kontopodis et al.11 concluded from the published data that UGTI is more effective than and as safe as UGCT and should be used as the primary modality to treat iatrogenic pseudoaneurysms.11 However, until now, there is no clear guidelines regarding the preferred first-line modality in the management of iatrogenic femoral pseudoaneurysms. In conclusion, although both treatment modalities (UGCT and UGTI) are safe, and the UGTI should be considered in uncomplicated femoral pseudoaneurysms as efficient first line of management because it has a high success rate and a lower overall cost.
Conflicts of interest The authors have none to declare.
references
1. Horn M, Stahlberg E, Goltz JP, et al. Management of groin pseudoaneurysms: indications and outcomes for thrombin injection vs. Surgical treatment. Vasc Med Surg. 2017;5:1.
Please cite this article as: Rashaideh MA et al., Ultrasound-guided thrombin injection versus ultrasound-guided compression therapy of iatrogenic femoral false aneurysms: Single center experience, Medical Journal Armed Forces India, https://doi.org/10.1016/ j.mjafi.2019.09.004
medical journal armed forces india xxx (xxxx) xxx
2. Katzenschlager R, Ugurluoglu A, Ahmadi A, et al. Incidence of pseudoaneurysm after diagnostic and therapeutic angiography. Radiology. 1995;195:463e466. 3. Hessel SJ, Adams DF, Abrams HL. Complications of angiography. Radiology. 1981;138:273e281. 4. Wixon CL, Philpott JW, Bogey Jr WM, et al. Duplex- directed thrombin injection as a method to treat femoral artery pseudoaneurysms. J Am Coll Surg. 1998;187:464e466. 5. Franklin JA, Brigham D, Bogey WM, Powell CS. Treatment of iatrogenic false aneurysms. J Am Coll Surg. 2003;197:2. 6. Fellmeth BD, Roberts AC, Bookstein JJ, et al. Postangiographic femoral artery injuries: nonsurgical repair with US-guided compression. Radiology. 1991;178:671e675. 7. Chou YH, Tiu CM, Chiang BN, Chang T. Real-time and imagedirected Doppler ultrasonography in deep femoral artery pseudoaneurysm: a new observation with graded compression of the femoral artery. J Clin Ultrasound. 1991;19:438e441. 8. Kumins NH, Landau DS, Montalvo J, et al. Expanded indications for the treatment of postcatherization femoral pseudoaneurysms with ultrasound-guided compression. Am J Surg. 1998;176:131e136. 9. Liau CS, Ho FM, Chen MF, Lee YT. Treatment of iatrogenic femoral artery pseudoaneurysm with percutaneous thrombin injection. J Vasc Surg. 1997;26:18e23. 10. Webber GW, Jang J, Gustavson S, Olin JW. Contemporary management of postcatheterization pseudoaneurysms. Circulation. 2007;115:2666e2674. 11. Kontopodis N, Tsetis D, Tavlas E, et al. Ultrasound guided compression versus ultrasound guided thrombin injection for the treatment of post-catheterization femoral pseudoaneurysms: systematic review and meta-analysis of comparative studies. Eur J Vasc Endovasc Surg. 2016 Jun;51(6):815e823. 12. Stone PA, AbuRahma AF, Flaherty SK, et al. Femoral pseudoaneurysms. Vasc Endovasc Surg. 2006;40:109e117. 13. Middleton WD, Dasyam A, Teefey SA. Diagnosis and treatment of iatrogenic femoral artery pseudoaneurysms. Ultrasound Q. 2005;21(1):3e17. 14. Saad NE, Davies MG, Waldman DL, et al. Pseudoaneurysms and the role of minimally invasive techniques in their management. RadioGraphics. 2005;25:173e189. 15. Feld R, Patton GM, Carabasi A, et al. Treatment of iatrogenic femoral artery injuries with ultrasound-guided compression. J Vasc Surg. 1992;16:832e840. 16. Dean SM, Olin JW, Piedmonte M, et al. Ultrasound-guided compression closure of postcatherization pseudoaneurysms during concurrent anticoagulation: a review of seventy-seven patients. J Vasc Surg. 1996;23:28e34. 17. Chatterjee T, Do DD, Kaufmann U, et al. Ultrasound-guided compression repair for treatment of femoral artery
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pseudoaneurysm: acute and follow-up results. Cathet Cardiovasc Diagn. 1996;38:335e340. Paulson EK, Sheafor DH, Kliewer MA, et al. Treatment of iatrogenic femoral arterial pseudo- aneurysms: comparison of US-guided thrombin injection with compression repair. Radiology. 2000 May;215(2):403e408. Coley BD, Roberts AC, Fellmeth BD, Valji K, Bookstein JJ, Hye RJ. Post angiographic femoral artery pseudoaneurysms: further experience with US-guided compression repair. Radiology. 1995;194(2):307e311. € rge G, Kunz T, Kirstein M. A prospective study on Go ultrasound-guided compression therapy or thrombin injection for treatment of iatrogenic false aneurysms in patients receiving full-dose antiplatelet therapy. Z Kardiol. 2003;92:564e570. Weinmann EE, Chayen D, Kobzantzev ZV, Zaretsky M, Bass A. Treatment of postcatheterisation false aneurysms: ultrasound-guided compression vs ultrasound-guided thrombin injection. Eur J Vasc Endovasc Surg. 2002 Jan;23(1):68e72. Eisenberg L, Paulson EK, Kliewer MA, et al. Sonographically guided compression repair of pseudoaneurysms: further experience from a single institution. Am J Roentgenol. 1999;173:1567e1573. Liu Y-M, Hua Y, Liu Q, et al. Efficacy comparison of different treatment methods for femoral pseudoaneurysms under ultrasonographic guidance. Chin J Cerebrovasc Dis. 2006;10, 433-6El. Chen DH, Sammel AM, Jain P, Jepson NS. Cardiologist operated ultrasound guided thrombin injection as a safe and efficacious first line treatment for iatrogenic femoral artery pseudoaneurysms. Heart, lung and circulation. 2015 Feb;24(2):165e172. Krueger K, Zaehringer M, Strohe D, et al. Post catheterization pseudoaneurysm: results of US-guided percutaneous thrombin injection in 240 patients. Radiology. 2005;236:1104e1110. Vlachou PA, Karkos CD, Bains S, et al. Percutaneous ultrasound-guided thrombin injection for the treatment of iatrogenic femoral artery pseudoaneurysms. Eur J Radiol. 2011;77:172e174. Taylor BS, Rhee RY, Muluk S, et al. Thrombin injection versus compression of femoral artery pseudoaneurysms. J Vasc Surg. 1999;30:1052e1059. € nn L, Olmarker A, Geterud K, et al. Prospective randomized Lo study comparing ultrasound-guided thrombin injection to compression in the treatment of femoral pseudoaneurysms. J Endovasc Ther. 2004;11:570e576. Tisi PV, Callam MJ. Treatment for femoral pseudoaneurysms. Cochrane Database Syst Rev. 2013 Nov 29;11. CD004981 Review. PubMed PMID: 24293322.
Please cite this article as: Rashaideh MA et al., Ultrasound-guided thrombin injection versus ultrasound-guided compression therapy of iatrogenic femoral false aneurysms: Single center experience, Medical Journal Armed Forces India, https://doi.org/10.1016/ j.mjafi.2019.09.004
Available online at www.sciencedirect.com
ScienceDirect j o u r n a l h o m e p a g e : w w w . e l s e v i e r . c o m / l o c a t e / m j a fi
Original Article
Ultrasound-guided thrombin injection versus ultrasound-guided compression therapy of iatrogenic femoral false aneurysms: Single center experience Mohammed A. Rashaideh a,*, Kristi E. Janho a, Jameel S. Shawaqfeh b, Eyad Ajarmeh a, Mohammed As'ad a a b
Vascular Surgery, King Hussin Medical Center, Amman, Jordan Radiology, King Hussin Medical Center, Amman, Jordan
article info
abstract
Article history:
Background: Iatrogenic femoral pseudoaneurysm (false aneurysm) due to arterial access
Received 20 May 2019
following cardiovascular procedures is becoming common because of the increase in
Accepted 24 September 2019
number and complexity of the procedures. Recently, percutaneous thrombin injection is
Available online xxx
becoming a popular treatment of these false aneurysms.
Keywords:
closure using ultrasound-guided thrombin injection in comparison to ultrasound-guided
False aneurysm
compression.
Pseudoaneurysm
Methods: A retrospective analysis was undertaken of 65 patients who presented to our
Iatrogenic compression
vascular department with iatrogenic femoral pseudoaneurysm between January 2015 and
Ultrasound-guided thrombin
March 2019. Twenty-five patients underwent ultrasound-guided thrombin injection, and 40
The aim of this study was to assess the efficacy and safety of femoral pseudoaneurysm
were treated using ultrasound-guided compression therapy. The primary outcome measured was efficacy, while other outcomes examined were safety, procedure duration, and cost. Results: A total of 65 patients (45 males, 20 female) were identified with a mean age of 62 years. Out of the 65, 40 patients (28 males, 12 female) underwent ultrasound-guided compression therapy (group A) with a mean aneurysm size of 2.9 cm, and 25 (17 male, 8 female) underwent ultrasound-guided thrombin injection (group B) with a mean pseudoaneurysm sac size of 3.7 cm. The success rate of thrombosis in group A was 70% and in group B was 92%. No significant complications were reported in both groups. Conclusions: Ultrasound-guided thrombin injection should be considered as the first line of treatment for uncomplicated femoral pseudoaneurysms because it has a higher thrombosis and lower recurrence rates, when compared with ultrasound-guided compression treatment. © 2019 Director General, Armed Forces Medical Services. Published by Elsevier, a division of RELX India Pvt. Ltd. All rights reserved.
* Corresponding author. E-mail address: [email protected] (M.A. Rashaideh). https://doi.org/10.1016/j.mjafi.2019.09.004 0377-1237/© 2019 Director General, Armed Forces Medical Services. Published by Elsevier, a division of RELX India Pvt. Ltd. All rights reserved. Please cite this article as: Rashaideh MA et al., Ultrasound-guided thrombin injection versus ultrasound-guided compression therapy of iatrogenic femoral false aneurysms: Single center experience, Medical Journal Armed Forces India, https://doi.org/10.1016/ j.mjafi.2019.09.004
2
medical journal armed forces india xxx (xxxx) xxx
Introduction Pseudoaneurysm (false aneurysm) is a contained pulsatile blood flow with disruption of all the vessel layers (intima, media, and adventitia) and surrounded by tissues.1 Femoral artery is the preferred site for access in the vast majority of diagnostic and therapeutic endovascular procedures (cardiac, aortic, and peripheral). The femoral artery false aneurysms incidence varies widely in the literature from 0.05% to 8.0%.2,3 The increasing number and complexity of the procedures in addition to the usage of potent antiplatelets and anticoagulants might be the cause of the increased frequency of the pseudoaneurysms. The preferred method for the diagnosis of iatrogenic femoral pseudoaneurysms is color Doppler ultrasound,4 with the ying-yang sign being pathognomonic (Fig. 1). By using ultrasound, many features of the pseudoaneurysm can be described as size, neck features, and vessel of origin.5 The management of all iatrogenic femoral pseudoaneurysms was surgical intervention. Although it is curative, surgery is associated with higher morbidity, mortality, and prolonged hospital stay. Nowadays, surgical repair is being reserved only for complicated pseudoaneurysms (compression symptoms, skin changes, rupture, limb ischemia, and short wide neck) and when other modalities fail to obliterate the aneurysm. Ultrasound-guided compression repair (UGCR) of femoral artery pseudoaneurysms was first described in 1991.6,7 This method was adopted by many physicians as a non-invasive successful alternative for surgery. Contraindications to compression include infection, skin ischemia, pressure symptoms on the nearby neurovascular structures, and severe pain.5,8 The success rates of UGCR were reported in the literature from 54% to 100%, and the predictors of success with UGCR are not well understood.5 In 1997, Liau et al. introduced ultrasound-guided percutaneous thrombin injection repair (UGTI) of iatrogenic pseudoaneurysms.9 The success rates for UGTI ranged from 91% to 100%, with a complication rate around 1.3%, including only 0.5% embolic events.10,11 Despite the potential complications, the advantages of UGTI include good patient tolerance, the high success rate, independency of procedure success on anticoagulation, and rapidity of the procedure. Some authors have even adopted UGTI as a standard of care for iatrogenic peripheral vascular pseudoaneurysms because of the high patient and physician satisfaction, ease of the procedure, and the low incidence of complications.5
clinical and the demographic data along with the treatment results was performed. The pseudoaneurysm sac and the neck characteristics along with the artery of origin were first identified using Doppler ultrasound, then continuous compression using the ultrasound probe was performed targeting the pseudoaneurysm neck to cease the flow inside the sac, while maintaining flow in the native artery. Re-evaluation of the color flow inside the sac at 10-min intervals was conducted. This technique was repeated until the pseudoaneurysm was totally thrombosed. Analgesia was given as required when there was unbearable pain during the procedure. The thrombin injection was done using aseptic technique with ultrasound guidance. The pseudoaneurysm features were first identified. Using the ultrasound B-mode, the most superficial entry point was marked. Then a 21-gauge spinal needle is advanced into the center of the sac away from the orifice, once back flow was noticed, a 5000 IU recombinant topical thrombin (Recothrom; ZymoGenetics Inc, Seattle, WA) reconstituted in 5 mL sterile saline was slowly injected with 100 IU at a time. The flow in the sac was continuously observed until complete thrombosis was achieved. Fig. 2. In both procedures, the nearby arteries and veins were imaged after completion to document their patency and were
Material and methods This study was approved by the ethical committee at our institution. The informed consent was waived because the data were analyzed retrospectively. The patients’ data were extracted from the vascular lab records at our department during the period of January 2015 to March 2019. A total of 65 patients were identified. All patients had iatrogenic femoral pseudoaneurysm diagnosed by Doppler ultrasound and were treated by compression or thrombin injection during same scanning session. Analysis of the
Fig. 1 e Color Doppler image showing femoral false aneurysm (yellow arrow) with the ying-yang sign, with the neck (black arrow) arising from the profunda femoral artery (PFA) (red arrow).
Please cite this article as: Rashaideh MA et al., Ultrasound-guided thrombin injection versus ultrasound-guided compression therapy of iatrogenic femoral false aneurysms: Single center experience, Medical Journal Armed Forces India, https://doi.org/10.1016/ j.mjafi.2019.09.004
3
medical journal armed forces india xxx (xxxx) xxx
compared with the baseline before the procedure. After successful thrombosis, the patient was kept supine with bed rest for 30 min. A follow-up ultrasound was obtained after 1 week for detection of recurrence.
Results In our institution, ultrasound-guided compression therapy of femoral pseudoaneurysms was the treatment of choice until February 2017, when this modality was replaced by ultrasound-guided thrombin injection. A retrospective analysis of the 40 patients (28 males, 12 females) with 40 pseudoaneurysms who underwent Ultrasound-Guided Compression Therapy ( UGCT) from January 2015 to February 2017 (group A) was conducted. The average age in this group was 60.7 years (range, 41e83 years). All the patients were on antiplatelets. The compression was overall successful in 28 patients (70%) including repeated compression in 5 patients. All pseudoaneurysms in this group were postcardiac catheterization. The average compression time was 36 min (range, 25e60 min). The average size of the false aneurysm in this group was 2.9 cm (range, 1.8e4.2 cm). Those patients with failed compression and persistent aneurysms underwent surgical repair. Analgesia during compression therapy was required in 14 (35%) patients. From February 2017 to March 2019, we managed 25 patients (17 males, 8 females) with 25 pseudoaneurysms using UGTI (group B). The average age in this group was 63.9 years (range, 52e81 years), and the average sac size was 3.7 cm (range, 2.5e5.4 cm). All patients were on antiplatelet therapy. The success rate of complete obliteration of the false aneurysms with thrombin injection was 92%. Twenty-four of the aneurysms were caused by cardiac catheterization, and one case was postperipheral angiography. Analgesia was not required in this group of patients. The mean duration from symptoms of the pseudoaneurysm and the institution of either treatment method was 4 days (1e14 days). All the patients of both groups were
Table 1 e Summary of the demographics of the patients with femoral pseudoaneurysms. Patient characteristics
Total
UGCT
UGTI
No. of patients Average age(year) Sex (M/F) Antiplatelets Anticoagulation Procedure Cardiac Peripheral Average pseudoaneurysm size
65 62 45/20 65 0
40 60.7 28/12 40 0
25 63.9 17/8 25 0
64 1 3.2
40 0 2.9
24 1 3.7
UGTI, ultrasound-guided percutaneous thrombin injection repair.
reviewed 1 week after the procedure, where a follow-up ultrasound was arranged. Pseudoaneurysms that did not show complete thrombosis on follow-up visit underwent second session of treatment. Open surgical repair was done after recurrent failure. No significant complications were reported in any of the patients in either group, apart from the discomfort and pain during handling of the pseudoaneurysm throughout ultrasound compression or injection. The average cost was calculated per patient for both groups and was $490 and $182 for compression and thrombin injection, respectively. The calculations were based on the vascular lab time, operation room time, and the cost of supplies. Tables 1 and 2 summarize the demographic features of the patients and the results of the treatment in both groups, respectively.
Discussion The incidence of femoral postcatheterization pseudoaneurysm has increased in the past years and was reported in many studies from 0.2% to 8.0%.2,3 Mostly, this wide range of incidence is attributed to the complexity of the procedures, vessel wall characteristics and to the use of potent antiplatelets and anticoagulants.
Fig. 2 e (a) Prethrombin injection: showing femoral false aneurysm (yellow arrow) arising from the common femoral artery. (b) Postthrombin injection: showing the same pseudoaneurysm with complete sac thrombosis (red arrow) with patent superficial femoral artery (SFA) and femoral vein (FV). Please cite this article as: Rashaideh MA et al., Ultrasound-guided thrombin injection versus ultrasound-guided compression therapy of iatrogenic femoral false aneurysms: Single center experience, Medical Journal Armed Forces India, https://doi.org/10.1016/ j.mjafi.2019.09.004
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Table 2 e Summary of the results of femoral pseudoaneurysm treatment using UGCT and UGTI. Procedure outcome
UGCT
UGTI
Success rate Average time to obliteration Average procedure time Complications Average cost $
70% 36 min 60 min 0 490
92% s 15 min 0 182
UGTI, ultrasound-guided percutaneous thrombin injection repair.
In our department, the diagnosis of all pseudoaneurysms was done in the vascular lab using color Doppler ultrasound. In all cases, the origin of the pseudoaneurysm was below the inguinal ligament except one case where the origin was from the distal external iliac artery. The treatment options we apply for femoral pseudoaneurysms include surgical repair, UGCT, UGTI and other rarely used methods such as coil embolization and covered stents. Surgical repair was conventionally applied for all pseudoaneurysms, but currently it is reserved for the complicated cases such as: compressive pseudoaneurysms, skin changes, associated arterio-venous fistula, and after failure of other modalities. These cases were excluded from our analysis because ultrasound-guided therapy was not attempted. Also, small aneurysms less than 1.5 cm diameter were treated conservatively and were excluded. Ultrasound-guided compression obliteration has become the first-line treatment of pseudoaneurysms at many institutions.12,13 It is considered to be safe, reproducible, and cost effective modality.14e17 However, it has some complications such as pain, failure, and recurrence, and it is considered to be a lengthy procedure which requires a great effort by the sonographer. Since 1991, many articles have been published assessing the efficacy and safety of UGCT. In the literature, the reported success rate with UGCT ranged from 54% to 100%.5 The etiology of treatment failure in the studies was variable, but the most frequent was the usage of anticoagulation and the large size of the sac.15e17 In our study, the UGCT was the preferred method until 2017. The total success rate in our series was 70%, counting five cases were thrombosed with repeated compression after 1 week. All patients who underwent UGCT were on antiplatelets therapy, but none was on anticoagulation. The average size of the sac in this group was 2.9 cm. Paulson et al. and Dean et al. reported a comparable success rates of 74% and 77%, respectively, with UGCT.16,18 However, higher success rates were reported by Coley et al., in which the occlusion rate was 93%.19 € rge et al. and Weinmann While in the studies done by G. Go et al., the success rates were 17% and 27%, respectively.20,21 The pseudoaneurysm size and anticoagulation both affect the success rate. In patients on anticoagulation, Eisenberg et al.22 and Coley et al.,19 experienced failure of the technique in 70% and 38% of patients, respectively compared with a failure rate of 26% and 5% in patients without anticoagulation. Coley et al.19 achieved a 100% success rate for small pseudoaneurysms of less than 2 cm in diameter and a 67% success rate for the sizes from 4 to 6 cm and further reduced success rate when the size was more than 6 cm.
Although, no major complications were reported in our series, complications such as pseudoaneurysm expansion or rupture, deep vein thrombosis (DVT), new onset cardiac events, and vasovagal attacks were reported in the literature as high as 3.4%.11,22 Despite the injection is an off-label use of topical thrombin, the UGTI has been frequently used since its introduction because of its high efficacy and safety. Although the success rates are very high, embolic and thrombotic complications were reported at a rate of 1.3% with only 0.5% embolic events.23 In this study, the success rate of UGTI was 92% with only two failed cases, both of them were large pseudoaneurysms of more than 5 cm in diameter and were injected with thrombin twice at different occasions. After the second failure, treatment with surgical repair deemed necessary. In our series with thrombin injection, all patients were on antiplatelets, but none was on anticoagulation, and there were no reported complications. Chen et al.24 reported in his series a primary success rate of 92%. According to Kreuger et al. and Vlachou et al.,25,26 higher failure rates of UGTI were reported in multilobed and large pseudoaneurysms. The anticoagulation status of the patients had not altered the UGTI success rate as reported by Chen et al.24 The procedure time and the total cost in our study were clearly obvious in favor of UGTI, which parallel the results in other studies.27,28 The average cost was calculated based on the procedure and vascular lab time in addition to the materials and operation room cost in cases when surgery was € nn et al. and Taylor et al., both reported that the needed. Lo calculated total cost was lower in the UGTI group.27,28 When reviewing the literature, there were many observational studies18,21,27,29 and few randomized controlled studies23,28 comparing UGCT with UGTI. In all these studies, the efficacy of UGTI was better with comparable complication rates. In a systematic review and meta-analysis of comparative studies between UGCT and UGTI, Kontopodis et al.11 concluded from the published data that UGTI is more effective than and as safe as UGCT and should be used as the primary modality to treat iatrogenic pseudoaneurysms.11 However, until now, there is no clear guidelines regarding the preferred first-line modality in the management of iatrogenic femoral pseudoaneurysms. In conclusion, although both treatment modalities (UGCT and UGTI) are safe, and the UGTI should be considered in uncomplicated femoral pseudoaneurysms as efficient first line of management because it has a high success rate and a lower overall cost.
Conflicts of interest The authors have none to declare.
references
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Please cite this article as: Rashaideh MA et al., Ultrasound-guided thrombin injection versus ultrasound-guided compression therapy of iatrogenic femoral false aneurysms: Single center experience, Medical Journal Armed Forces India, https://doi.org/10.1016/ j.mjafi.2019.09.004