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The Safety and Efficacy of a Percutaneous Closure Device in Patients Undergoing Uterine Artery Embolization
The Safety and Efficacy of a Percutaneous Closure Device in Patients Undergoing Uterine Artery Embolization Howard B. Chrisman, MD, MBA, David M. Liu, MD, FRCPC, James T. Bui, MD, Scott A. Resnick, MD, Kent Sato, MD, Richard Chen, DO, Robert L. Vogelzang, MD, and Reed A. Omary, MD PURPOSE: The use of suture-mediated closure devices (SMCDs) in patients undergoing uterine artery embolization (UAE) for symptomatic leiomyomata is controversial. With recent literature suggesting a higher complication rate with the use of SMCDs, their use in this specific population has been questioned. The purpose of this study is to assess the safety and efficacy of SMCDs specifically for those patients undergoing UAE for symptomatic uterine leiomyomata. MATERIALS AND METHODS: A prospective database was established in a single high-volume medical center for patients undergoing UAE for symptomatic leiomyomata. Data were tracked prospectively, with technical outcome and complication rates serving as endpoints. RESULTS: UAE was performed in 342 consecutive patients from January 2001 to September 2003. The SMCD was used in 328 of these patients (96%). Successful primary hemostasis was achieved in 320 of 328 patients (97%), with additional manual compression required in the remaining eight patients (3%). No major complications were observed. Minor complications consisted of minor hematomas in four women (1%) and anteriomedial thigh pain in 68 women (21%) within 1 month of follow-up, resulting in an overall complication rate of 22%. All symptoms related to anteromedial thigh pain ipsilateral to the arterial puncture site were managed conservatively with 1 week of oral nonsteroidal antiinflammatory medication. CONCLUSION: The SMCD provided safe and effective hemostasis in patients undergoing UAE. Transient thigh discomfort, which may result from irritation of the anterior femoral cutaneous nerves (femoral neuralgia syndrome), was uniformly relieved with nonsteroidal antiinflammatory therapy. J Vasc Interv Radiol 2005; 16:347–351 Abbreviations:
SMCD ⫽ suture-mediated closure device, UAE ⫽ uterine artery embolization
UTERINE artery embolization (UAE) has been established as an effective
From the Department of Radiology (H.B.C., S.A.R., K.S., R.C., R.L.V., R.A.O.), Interventional Radiology Section, Northwestern University, Northwestern Memorial Hospital; Department of Radiology (J.T.B.), Interventional Radiology Section, University of Illinois–Chicago, Chicago, Illinois; and Department of Radiology (D.M.L.), Interventional Radiology/Oncology Section, St. Vincent’s Hospital, Portland, Oregon. Received September 10, 2004; revision requested October 5; revision received October 8; accepted October 12. From the SIR 2004 Annual Meeting. Address correspondence to D.M.L., Interventional Radiology Section, Department of Radiology, St. Vincent’s Hospital, 9205 SW Barnes Rd., Portland, OR 97225; E-mail: david.liu@providence. org None of the authors have identified a conflict of interest. © SIR, 2005 DOI: 10.1097/01.RVI.0000149903.84071.99
and safe means for the treatment of symptomatic leiomyomata (1– 4). The application of SMCDs in the outpatient population has been extensively studied, with no conclusive evidence as to its safety or efficacy to date. Recently, reports that patients undergoing UAE for symptomatic leiomyomata had a major complication rate of 5% when subjected to SMCD (5), exceeding the 1%–3% major complication rate reported in larger sample sizes for use of SMCDs in patients with peripheral vascular disease and/or undergoing anticoagulation (6 – 8). Consequently, it is unclear whether SMCDs should be used in patients undergoing UAE. No current guidelines or standards have addressed the issue of the use of SMCD in this population (9). The purpose of this study is to investigate the safety
and efficacy of SMCDs in women undergoing UAE.
MATERIALS AND METHODS Institutional review board approval was obtained to retrieve data collected within the prospectively acquired hospital UAE database. Patient Group All patients undergoing UAE for symptomatic leiomyomata from January 2001 to September 2003 were subject to review. Three hundred fortytwo consecutive patients treated with UAE (age range, 32–54 years; mean age, 45 years) were evaluated for the use of the SMCD.
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Technique UAE was performed in selected prescreened patients after extensive consultation and preprocedural magnetic resonance imaging. Embolization was performed via a unilateral percutaneous approach through a 5.5-F sheath system. Ipsilateral and contralateral embolization to stasis was completed after selection of each uterine artery via a 4-F angle glide catheter or microcatheter system. After completion of embolization, delineation of the anatomy relative to the arteriotomy was accomplished by a directed digital subtraction angiogram through the vascular sheath. If anatomy was deemed optimal (no major vessel bifurcation or local vessels within 1 cm of the arteriotomy, aberrant anatomy, flow-limiting stenosis at site of arteriotomy, common femoral artery diameter ⬍5 mm, high common femoral artery bifurcation, or puncture above the inguinal ligament) and there was no other contraindication to deployment of the SMCD (prolonged procedure, loss of access, possible contamination, operator inexperience, out of inventory), primary hemostasis was attempted with the SMCD. For all patients undergoing SMCD, the Closer S device was used (Abbott Laboratories, Redwood City, CA). If no SMCD was deployed or a device failure occurred, 10 –25 minutes of manual graded compression was applied to achieve hemostasis. With successful deployment of the device, patient-controlled analgesia was initiated with instruction of immobilization of the limb of the puncture site for 2 hours. If the SMCD was not applied or failed, the patient was instructed to remain immobile for 6 hours. Patients were then observed for 23 hours. Discharge of the patient was dependent on control of pain and nausea, which was usually achieved the following morning. Follow-up was performed at 24 hours after the procedure; at 1, 3, and 6 months; and at 1 year, with entry of patient outcomes into an institutional review board–approved prospective database. Study Endpoints Failure of the device was defined as the inability to provide primary hemostasis after deployment. Postproce-
dural oozing that could be controlled within 2 minutes with mild compression was not considered to constitute failure. Complications relating to the arteriotomy site and/or SMCD were documented as per Society of Interventional Radiology (SIR) guidelines. Outcome measures were expressed with 99% confidence intervals. Efficacy of the closure device was defined by satisfactory hemostasis (with complete hemostasis within 2 minutes of deployment) and ability to ambulate within 2 hours. We assessed safety by classifying groin complications according to SIR guidelines (10). Information regarding the postprocedural condition and overall satisfaction of the procedure was also entered in the database.
RESULTS Contraindication to deployment of the SMCD were seen in 14 of 342 patients, resulting in attempted deployment in 328 patients. Device failure occurred in eight of 328 patients (2.4%; 99% CI, 0.2%– 4.6%) as a result of failure of capture of the firing needles, failure of the suture material, and/or operator error (with unsuccessful dissection of the superficial tissues to the arteriotomy site or operator inexperience). There were no long-term major complications. However, 68 of 328 patients (21%; 99% CI, 15%–27%) with successful primary hemostasis with use of the SMCD presented within 1 week of the procedure with mild anteromedial thigh pain ipsilateral to the arterial puncture site that radiated toward the knee. The pain, although not debilitating, was treated with 1 week of nonsteroidal antiinflammatory drug therapy with complete resolution of symptoms in all patients. This presentation was classified as a minor complication per SIR criteria. Four of 328 patients (1.2%; 99% CI, 0 –2.8%) had minor hematomas, which were classified as minor complications per SIR criteria. Total incidence of minor complications (when the presentation of anteromedial thigh pain ipsilateral to the arterial puncture site was accounted for) was 22% (72 of 328; 99% CI, 16%–28%). No distal embolization, occlusion, infection, or vessel dissection resulted from use of the SMCD.
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DISCUSSION UAE has been established as a safe and effective means of controlling the symptoms and sequelae of uterine leiomyomata (1,11–13). The population undergoing UAE represents a healthier, younger, and more ambulatory cohort than patients with peripheral vascular disease, with an expectation of a rapid alleviation and a true reversal of the disease process. In addition, optimizing patients for safe and expedient treatment under the therapeutic and clinical management of the interventionalist is paramount (14). The Closer S SMCD (Abbott Laboratories) is designed to provide primary hemostasis with a semiautomated mechanism that deploys a 3– 0 polyester braided suture adjacent to the arteriotomy site in an over-thewire 6.0-F configuration (15). The Closer S has been well established as a safe and effective means of establishing primary hemostasis in long-term prospective multicenter trials in patients undergoing cardiac catheterization in the Sutures to Ambulate and Discharge I and II trials (7). With older generations of the Closer device, decreased time to hemostasis, ambulation, and discharge were observed, with total major complication rates of 1% with SMCD use only and 2.4% when comparing manual compression with SMCD, with the complication rate associated with manual compression reported as 1.1% and the difference in complication rate determined to be statistically insignificant (7). Comparatively, major complications as a result of manual compression have been reported as 0.5%–2% (7,16 – 18). In addition, use of the device has also been validated in the vascular surgery literature, even in patients with dense calcifications at the arteriotomy site (19), with no significant increase in complication rates compared with the baseline population. These results suggest that complication rates related to SMCD use do not differ significantly from those with manual compression. The literature suggests that comparable performance and safety should exist between SMCD and manual compression in most patients, including those with peripheral vascular disease (20), patients without peripheral vascular
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disease undergoing anticoagulation (6,8), and those undergoing repeated SMCD (21). In our opinion, the overall complication rate (reported as 22%), because of our strict adherence to SIR reporting criteria, may be an overrepresentation of the minor complications associated with SMCD. As noted, 95% of these complications were account for by anteromedial thigh pain ipsilateral to the arterial puncture site, which was alleviated with prescription analgesics. Since the period of data collection, we discontinued this practice of administration of nonsteroidal antiinflammatory drugs because the discomfort subsides without further intervention. In addition, its late presentation, typically after discharge, was not debilitating. Although the presentation of anteromedial thigh pain ipsilateral to the arterial puncture site was intermittent, and no reliable predictors of its presentation have been identified to date, one may argue that the continuation of analgesics should be part of routine outpatient care, similar to the administration of prophylactic antibiotics. No lost workdays, surgical interventions, or significant sequelae resulted from this minor complication. The condition of anteromedial thigh pain after femoral arterial access has been coined the femoral neuralgia syndrome, which has been postulated to result from irritation of the anterior femoral cutaneous nerve in patients undergoing femoral catheterization with manual compression (22). Reviews of the literature regarding the relative anatomy in the region demonstrate medially coursing accessory nerves arising from the lateral femoral cutaneous nerve in 30% of cases and anterior branches in 36% in cavaderic dissections (23). The anteromedial thigh pain ipsilateral to the arterial puncture site may be a variant of meralgia parasthetica with nonclassical distribution resulting from the variant anatomy. Our reported occurrence of 21% (n ⫽ 68) was lower than the 30% incidence of meralgia parasthetica for manual compression cited by Hallett et al (22), but greater than the 2% incidence cited by Wagner et al (5). The true overall incidence of this presentation is likely present within our 99% confidence interval of 14%–25%. The issue of SMCD use is controversial in the UAE population for several reasons. Traditional methods of
Chrisman et al
manual compression have been defined as the standard of care, with a low major complication rate (5,18). The argument then holds that the SMCD serves only to add convenience to the procedure with no significant benefit to the patient. In addition, the long-term outcomes of the use of these types of devices have yet to be explored. Finally, the remote potential for site infection and embolization are virtually unique to device-assisted closure of the arteriotomy. Each of these issues warrants further discussion. As previously outlined by Pron and colleagues (24), management of postprocedural discomfort remains one of the top priorities in care of patients undergoing UAE. With the associated altered mental status of patients receiving patient-controlled analgesia, immobilization in the postprocedural recovery period can be challenging. The SMCD offers a shorter time to ambulation than traditional manual compression. With a greater confidence in the clinical management of these patients, arteriotomy closure devices may allow for the evolution of the UAE procedure into a same-day outpatient-based treatment (2). Although little is known regarding the long-term effects of the use of SMCDs, Brown et al (21) have concluded that repeat puncture through the arteriotomy has resulted in no further complication, and a return to normal vessel caliber has been appreciated in patients without significant atherosclerotic disease burden. Anklebrachial indexes after SMCD use remain statistically unchanged (5). However, animal models demonstrate a transient decrease in intraluminal diameter postprocedurally, with an angiographically undetectable periadventitial fibrotic process observed on histologic examination (25). These findings suggest that transient spasm or inflammation may result in compromise of the intraluminal diameter without sequelae. The most feared complications of infection (18,26,27), dissection, and embolism (28,29) were not observed in our study. These complications may potentially be minimized by adherence to meticulous sterile technique (ample irrigation, changing of gloves, clearing or resterilizing the arteriotomy field, preprocedural antibiotic administration) and by confirmation of
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appropriate indication and anatomy. For prolonged procedures, prophylactic antibiotic therapy before device deployment has been suggested (30). In our institution, skin flora coverage is provided through preprocedural antibiotic administration as part of the routine UAE protocol to reduce the chance of postprocedural infection. In addition, the manufacturer’s suggestions of glove exchange, ample irrigation, and strict adherence to sterile technique have all been incorporated into our practice. Compared with the current literature, our complication rates were within the accepted ranges of 1.2%– 6% for minor complications (6 – 8) and 0 –1.0% for major complications (6,8,18) with use of the Closer S SMCD. The overall incidence of infection in the arteriotomy site is unknown. Diagnosis and management of these infections have been restricted to case reports and remain rare occurrences in the literature. This study has several important limitations. First, this was a prospective case series with no randomized arm. Because the database was primarily constructed to measure clinical outcomes and results, randomization of patients to SMCD and non-SMCD groups was not incorporated into its initial design. A prospective study that randomizes patients into SMCD versus manual compression treatment arms would be preferable. Second, the SMCD used for all attempts at devicemediated closure was from a single manufacturer, and as a result, the data collected may not be applicable to alternative methods of hemostasis, such as hemostatic patches (31), collagenmediated devices (32), or even other types of SMCDs (15). Third, long-term results are still pending, as the longest period of clinical observation has been only 3 years. Finally, no direct correlation between successful SMCD deployment and improved outcomes or increased patient satisfaction has been established. In conclusion, the standards of UAE have yet to be defined. Alternate models of pain management such as epidural patient-controlled analgesia have been instituted in our facilities, which would preclude the need for SMCD (as a result of the patient’s postprocedural immobility) and have shown promising results. The resources may not be available to all
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practices and settings. The data presented in this article suggest that suture-mediated closure of the primary arteriotomy in the UAE population is a safe and effective means of hemostasis. The presentation of anterior medial thigh pain is easily controlled by oral analgesics and may warrant inclusion into the SIR procedure-related complications. The fundamental question that remains is whether deployment of the SMCD results in better patient outcomes and satisfaction. References 1. Pinto I, Chimeno P, Romo A, et al. Uterine fibroids: uterine artery embolization versus abdominal hysterectomy for treatment—a prospective, randomized, and controlled clinical trial. Radiology 2003; 226:425– 431. 2. Klein A, Schwartz ML. Uterine artery embolization for the treatment of uterine fibroids: an outpatient procedure. Am J Obstet Gynecol 2001; 184:1556 – 1560. 3. Spies JB. Uterine artery embolization for fibroids: understanding the technical causes of failure. J Vasc Interv Radiol 2003; 14:11–14. 4. Pron G, Bennett J, Common A, Wall J, Asch M, Sniderman K. The Ontario Uterine Fibroid Embolization Trial. Part 2: uterine fibroid reduction and symptom relief after uterine artery embolization for fibroids. Fertil Steril 2003; 79:120 –127. 5. Wagner SC, Gonsalves CF, Eschelman DJ, Sullivan KL, Bonn J. Complications of a percutaneous suture-mediated closure device versus manual compression for arteriotomy closure: a case-controlled study. J Vasc Interv Radiol 2003; 14:735–741. 6. Duda SH, Wiskirchen J, Erb M, et al. Suture-mediated percutaneous closure of antegrade femoral arterial access sites in patients who have received full anticoagulation therapy. Radiology 1999; 210:47–52. 7. Baim DS, Knopf WD, Hinohara T, et al. Suture-mediated closure of the femoral access site after cardiac catheterization: results of the suture to ambulate and discharge (STAND I and STAND II) trials. Am J Cardiol 2000; 85:864 – 869. 8. Applegate RJ, Grabarczyk MA, Little WC, et al. Vascular closure devices in patients treated with anticoagulation
9. 10.
11.
12.
13. 14.
15. 16.
17.
18.
19.
20.
21.
and IIb/IIIa receptor inhibitors during percutaneous revascularization. J Am Coll Cardiol 2002; 40:78 – 83. Spies JB, Sacks D. Credentials for uterine artery embolization. J Vasc Interv Radiol 2004; 15:111–113. Omary RA, Bettmann MA, Cardella JF, et al. Quality improvement guidelines for the reporting and archiving of interventional radiology procedures. J Vasc Interv Radiol 2002; 13:879 – 881. Pelage JP, Le Dref O, Soyer P, et al. Fibroid-related menorrhagia: treatment with superselective embolization of the uterine arteries and midterm follow-up. Radiology 2000; 215:428 – 431. Spies JB, Scialli AR, Jha RC, et al. Initial results from uterine fibroid embolization for symptomatic leiomyomata. J Vasc Interv Radiol 1999; 10:1149 –1157. ACOG Committee Opinion. Uterine artery embolization. Obstet Gynecol 2004; 103:403– 404. Brunner MC, Durham JD, Lewis CA, McClenny TE. Strategic initiatives in interventional radiology: the clinical imperative. J Vasc Interv Radiol 2003; 14:1099 –1101. Hoffer EK, Bloch RD. Percutaneous arterial closure devices. J Vasc Interv Radiol 2003; 14:865– 885. Facchini FR. Percutaneous arterial access: redefining the possibilities using suture-mediated closure (Perclose). Tech Vasc Interv Radiol 2003; 6:72–75. Rinder MR, Tamirisa PK, Taniuchi M, Kurz HI, Mumm K, Lasala JM. Safety and efficacy of suture-mediated closure after percutaneous coronary interventions. Cathet Cardiovasc Interv 2001; 54:146 –151. Carey D, Martin JR, Moore CA, Valentine MC, Nygaard TW. Complications of femoral artery closure devices. Cathet Cardiovasc Interv 2001; 52:3–7. Starnes BW, O’Donnell SD, Gillespie DL, et al. Percutaneous arterial closure in peripheral vascular disease: a prospective randomized evaluation of the Perclose device. J Vasc Surg 2003; 38:263–271. Mackrell PJ, Kalbaugh CA, Langan EM III, et al. Can the Perclose suture-mediated closure system be used safely in patients undergoing diagnostic and therapeutic angiography to treat chronic lower extremity ischemia? J Vasc Surg 2003; 38:1305–1308. Brown DB, Crawford ST, Norton PL, Hovsepian DM. Angiographic follow-up after suture-mediated femoral
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25.
26.
27.
28.
29.
30.
31.
32.
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artery closure. J Vasc Interv Radiol 2002; 13:677– 680. Hallett JW Jr, Wolk SW, Cherry KJ Jr, Gloviczki P, Pairolero PC. The femoral neuralgia syndrome after arterial catheter trauma. J Vasc Surg 1990; 11: 702–706. Dias Filho LC, Valenca MM, Guimaraes Filho FA, et al. Lateral femoral cutaneous neuralgia: an anatomical insight. Clin Anat 2003; 16:309 –316. Pron G, Mocarski E, Bennett J, et al. Tolerance, hospital stay, and recovery after uterine artery embolization for fibroids: the Ontario Uterine Fibroid Embolization Trial. J Vasc Interv Radiol 2003; 14:1243–1250. Hofmann LV, Sood S, Liddell RP, et al. Arteriographic and pathologic evaluation of two suture-mediated arterial closure devices in a porcine model. J Vasc Interv Radiol 2003; 14:755–761. Heck DV, Muldowney S, McPherson SH. Infectious complications of Perclose for closure of femoral artery punctures. J Vasc Interv Radiol 2002; 13:430 – 431. Johanning JM, Franklin DP, Elmore JR, Han DC. Femoral artery infections associated with percutaneous arterial closure devices. J Vasc Surg 2001; 34: 983–985. Boston US, Panneton JM, Hofer JM, et al. Infectious and ischemic complications from percutaneous closure devices used after vascular access. Ann Vasc Surg 2003; 17:66 –71. Prabhudesai A, Khan MZ. An unusual cause of femoral embolism: Angioseal. Ann R Coll Surg Engl 2000; 82:355–356. Geary K, Landers JT, Fiore W, Riggs P. Management of infected femoral closure devices. Cardiovasc Surg 2002; 10: 161–163. Fischer TH, Connolly R, Thatte HS, Schwaitzberg SS. Comparison of structural and hemostatic properties of the poly-N-acetyl glucosamine Syvek Patch with products containing chitosan. Microsc Res Tech 2004; 63:168 – 174. Michalis LK, Rees MR, Patsouras D, et al. A prospective randomized trial comparing the safety and efficacy of three commercially available closure devices (Angioseal, Vasoseal and Duett). Cardiovasc Intervent Radiol 2002; 25:423– 429.
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Chrisman et al
Examination available at http://directory.sirweb.org/jvircme CME QUESTIONS 1) Advantages of SMCD usage over manual compression include all of the following EXCEPT: 䡬 䡬 䡬 䡬
a) b) c) d)
decreased time to ambulation shorter period of post procedural manual compression lower chance of post procedural embolization/infection less stringent post procedural observation at the groin puncture site
2) Contraindications for SMCD deployment include all of the following EXCEPT: 䡬 䡬 䡬 䡬
a) b) c) d)
prolonged procedure atherosclerotic disease major bifurcation within 1 cm of the arteriotomy thigh stenosis at or near the arteriotomy
3) The overall complication rate of 22% reported in this series: 䡬 䡬 䡬 䡬
a) b) c) d)
would dictate that the clinician should change to another method of hemostasis may be an overrepresentation of minor complications represents significant debilitation of the post-procedure patient is consistent with the current literature
4) Post SMCD anteromedial thigh pain may be managed by: 䡬 䡬 䡬 䡬
a) b) c) d)
open surgical resection of the SMCD deep massage over the arteriotomy site 2 week course of oral narcotics a short course of non steroidal anti-inflammatory medication
SIR JOURNAL CME PROGRAM The SIR Journal CME Program is a convenient way to fulfill your CME requirements while learning important information about the latest advances in medicine and research. Every other month, one article in the Journal of Vascular and Interventional Radiology (JVIR) will have a companion CME exam available online. SIR members are eligible to take the online exams at no cost; Non-Members can take the online exams for a $20.00 fee. New CME exams are available bi-monthly and will remain online for one year. Objectives After evaluating a specific article published in the Journal of Vascular and Interventional Radiology, participants in the SIR Journal CME Program should be able to • demonstrate an increase in, or affirmation of, their knowledge of clinical medicine and research. • evaluation the appropriateness of the clinical information as it applies to the provision of patient care. Participants This program is designed for interventional radiologists who are involved in providing patient care and who wish to advance their current knowledge of clinical medicine and research. Credits The Society of Interventional Radiology is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. The Society of Interventional Radiology designates this enduring activity for a maximum of 1.0 category 1 credits toward the AMA Physician’s Recognition Award.
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SMCD ⫽ suture-mediated closure device, UAE ⫽ uterine artery embolization
UTERINE artery embolization (UAE) has been established as an effective
From the Department of Radiology (H.B.C., S.A.R., K.S., R.C., R.L.V., R.A.O.), Interventional Radiology Section, Northwestern University, Northwestern Memorial Hospital; Department of Radiology (J.T.B.), Interventional Radiology Section, University of Illinois–Chicago, Chicago, Illinois; and Department of Radiology (D.M.L.), Interventional Radiology/Oncology Section, St. Vincent’s Hospital, Portland, Oregon. Received September 10, 2004; revision requested October 5; revision received October 8; accepted October 12. From the SIR 2004 Annual Meeting. Address correspondence to D.M.L., Interventional Radiology Section, Department of Radiology, St. Vincent’s Hospital, 9205 SW Barnes Rd., Portland, OR 97225; E-mail: david.liu@providence. org None of the authors have identified a conflict of interest. © SIR, 2005 DOI: 10.1097/01.RVI.0000149903.84071.99
and safe means for the treatment of symptomatic leiomyomata (1– 4). The application of SMCDs in the outpatient population has been extensively studied, with no conclusive evidence as to its safety or efficacy to date. Recently, reports that patients undergoing UAE for symptomatic leiomyomata had a major complication rate of 5% when subjected to SMCD (5), exceeding the 1%–3% major complication rate reported in larger sample sizes for use of SMCDs in patients with peripheral vascular disease and/or undergoing anticoagulation (6 – 8). Consequently, it is unclear whether SMCDs should be used in patients undergoing UAE. No current guidelines or standards have addressed the issue of the use of SMCD in this population (9). The purpose of this study is to investigate the safety
and efficacy of SMCDs in women undergoing UAE.
MATERIALS AND METHODS Institutional review board approval was obtained to retrieve data collected within the prospectively acquired hospital UAE database. Patient Group All patients undergoing UAE for symptomatic leiomyomata from January 2001 to September 2003 were subject to review. Three hundred fortytwo consecutive patients treated with UAE (age range, 32–54 years; mean age, 45 years) were evaluated for the use of the SMCD.
347
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Use of a Percutaneous Closure Device in Patients Undergoing UAE
Technique UAE was performed in selected prescreened patients after extensive consultation and preprocedural magnetic resonance imaging. Embolization was performed via a unilateral percutaneous approach through a 5.5-F sheath system. Ipsilateral and contralateral embolization to stasis was completed after selection of each uterine artery via a 4-F angle glide catheter or microcatheter system. After completion of embolization, delineation of the anatomy relative to the arteriotomy was accomplished by a directed digital subtraction angiogram through the vascular sheath. If anatomy was deemed optimal (no major vessel bifurcation or local vessels within 1 cm of the arteriotomy, aberrant anatomy, flow-limiting stenosis at site of arteriotomy, common femoral artery diameter ⬍5 mm, high common femoral artery bifurcation, or puncture above the inguinal ligament) and there was no other contraindication to deployment of the SMCD (prolonged procedure, loss of access, possible contamination, operator inexperience, out of inventory), primary hemostasis was attempted with the SMCD. For all patients undergoing SMCD, the Closer S device was used (Abbott Laboratories, Redwood City, CA). If no SMCD was deployed or a device failure occurred, 10 –25 minutes of manual graded compression was applied to achieve hemostasis. With successful deployment of the device, patient-controlled analgesia was initiated with instruction of immobilization of the limb of the puncture site for 2 hours. If the SMCD was not applied or failed, the patient was instructed to remain immobile for 6 hours. Patients were then observed for 23 hours. Discharge of the patient was dependent on control of pain and nausea, which was usually achieved the following morning. Follow-up was performed at 24 hours after the procedure; at 1, 3, and 6 months; and at 1 year, with entry of patient outcomes into an institutional review board–approved prospective database. Study Endpoints Failure of the device was defined as the inability to provide primary hemostasis after deployment. Postproce-
dural oozing that could be controlled within 2 minutes with mild compression was not considered to constitute failure. Complications relating to the arteriotomy site and/or SMCD were documented as per Society of Interventional Radiology (SIR) guidelines. Outcome measures were expressed with 99% confidence intervals. Efficacy of the closure device was defined by satisfactory hemostasis (with complete hemostasis within 2 minutes of deployment) and ability to ambulate within 2 hours. We assessed safety by classifying groin complications according to SIR guidelines (10). Information regarding the postprocedural condition and overall satisfaction of the procedure was also entered in the database.
RESULTS Contraindication to deployment of the SMCD were seen in 14 of 342 patients, resulting in attempted deployment in 328 patients. Device failure occurred in eight of 328 patients (2.4%; 99% CI, 0.2%– 4.6%) as a result of failure of capture of the firing needles, failure of the suture material, and/or operator error (with unsuccessful dissection of the superficial tissues to the arteriotomy site or operator inexperience). There were no long-term major complications. However, 68 of 328 patients (21%; 99% CI, 15%–27%) with successful primary hemostasis with use of the SMCD presented within 1 week of the procedure with mild anteromedial thigh pain ipsilateral to the arterial puncture site that radiated toward the knee. The pain, although not debilitating, was treated with 1 week of nonsteroidal antiinflammatory drug therapy with complete resolution of symptoms in all patients. This presentation was classified as a minor complication per SIR criteria. Four of 328 patients (1.2%; 99% CI, 0 –2.8%) had minor hematomas, which were classified as minor complications per SIR criteria. Total incidence of minor complications (when the presentation of anteromedial thigh pain ipsilateral to the arterial puncture site was accounted for) was 22% (72 of 328; 99% CI, 16%–28%). No distal embolization, occlusion, infection, or vessel dissection resulted from use of the SMCD.
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DISCUSSION UAE has been established as a safe and effective means of controlling the symptoms and sequelae of uterine leiomyomata (1,11–13). The population undergoing UAE represents a healthier, younger, and more ambulatory cohort than patients with peripheral vascular disease, with an expectation of a rapid alleviation and a true reversal of the disease process. In addition, optimizing patients for safe and expedient treatment under the therapeutic and clinical management of the interventionalist is paramount (14). The Closer S SMCD (Abbott Laboratories) is designed to provide primary hemostasis with a semiautomated mechanism that deploys a 3– 0 polyester braided suture adjacent to the arteriotomy site in an over-thewire 6.0-F configuration (15). The Closer S has been well established as a safe and effective means of establishing primary hemostasis in long-term prospective multicenter trials in patients undergoing cardiac catheterization in the Sutures to Ambulate and Discharge I and II trials (7). With older generations of the Closer device, decreased time to hemostasis, ambulation, and discharge were observed, with total major complication rates of 1% with SMCD use only and 2.4% when comparing manual compression with SMCD, with the complication rate associated with manual compression reported as 1.1% and the difference in complication rate determined to be statistically insignificant (7). Comparatively, major complications as a result of manual compression have been reported as 0.5%–2% (7,16 – 18). In addition, use of the device has also been validated in the vascular surgery literature, even in patients with dense calcifications at the arteriotomy site (19), with no significant increase in complication rates compared with the baseline population. These results suggest that complication rates related to SMCD use do not differ significantly from those with manual compression. The literature suggests that comparable performance and safety should exist between SMCD and manual compression in most patients, including those with peripheral vascular disease (20), patients without peripheral vascular
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disease undergoing anticoagulation (6,8), and those undergoing repeated SMCD (21). In our opinion, the overall complication rate (reported as 22%), because of our strict adherence to SIR reporting criteria, may be an overrepresentation of the minor complications associated with SMCD. As noted, 95% of these complications were account for by anteromedial thigh pain ipsilateral to the arterial puncture site, which was alleviated with prescription analgesics. Since the period of data collection, we discontinued this practice of administration of nonsteroidal antiinflammatory drugs because the discomfort subsides without further intervention. In addition, its late presentation, typically after discharge, was not debilitating. Although the presentation of anteromedial thigh pain ipsilateral to the arterial puncture site was intermittent, and no reliable predictors of its presentation have been identified to date, one may argue that the continuation of analgesics should be part of routine outpatient care, similar to the administration of prophylactic antibiotics. No lost workdays, surgical interventions, or significant sequelae resulted from this minor complication. The condition of anteromedial thigh pain after femoral arterial access has been coined the femoral neuralgia syndrome, which has been postulated to result from irritation of the anterior femoral cutaneous nerve in patients undergoing femoral catheterization with manual compression (22). Reviews of the literature regarding the relative anatomy in the region demonstrate medially coursing accessory nerves arising from the lateral femoral cutaneous nerve in 30% of cases and anterior branches in 36% in cavaderic dissections (23). The anteromedial thigh pain ipsilateral to the arterial puncture site may be a variant of meralgia parasthetica with nonclassical distribution resulting from the variant anatomy. Our reported occurrence of 21% (n ⫽ 68) was lower than the 30% incidence of meralgia parasthetica for manual compression cited by Hallett et al (22), but greater than the 2% incidence cited by Wagner et al (5). The true overall incidence of this presentation is likely present within our 99% confidence interval of 14%–25%. The issue of SMCD use is controversial in the UAE population for several reasons. Traditional methods of
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manual compression have been defined as the standard of care, with a low major complication rate (5,18). The argument then holds that the SMCD serves only to add convenience to the procedure with no significant benefit to the patient. In addition, the long-term outcomes of the use of these types of devices have yet to be explored. Finally, the remote potential for site infection and embolization are virtually unique to device-assisted closure of the arteriotomy. Each of these issues warrants further discussion. As previously outlined by Pron and colleagues (24), management of postprocedural discomfort remains one of the top priorities in care of patients undergoing UAE. With the associated altered mental status of patients receiving patient-controlled analgesia, immobilization in the postprocedural recovery period can be challenging. The SMCD offers a shorter time to ambulation than traditional manual compression. With a greater confidence in the clinical management of these patients, arteriotomy closure devices may allow for the evolution of the UAE procedure into a same-day outpatient-based treatment (2). Although little is known regarding the long-term effects of the use of SMCDs, Brown et al (21) have concluded that repeat puncture through the arteriotomy has resulted in no further complication, and a return to normal vessel caliber has been appreciated in patients without significant atherosclerotic disease burden. Anklebrachial indexes after SMCD use remain statistically unchanged (5). However, animal models demonstrate a transient decrease in intraluminal diameter postprocedurally, with an angiographically undetectable periadventitial fibrotic process observed on histologic examination (25). These findings suggest that transient spasm or inflammation may result in compromise of the intraluminal diameter without sequelae. The most feared complications of infection (18,26,27), dissection, and embolism (28,29) were not observed in our study. These complications may potentially be minimized by adherence to meticulous sterile technique (ample irrigation, changing of gloves, clearing or resterilizing the arteriotomy field, preprocedural antibiotic administration) and by confirmation of
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appropriate indication and anatomy. For prolonged procedures, prophylactic antibiotic therapy before device deployment has been suggested (30). In our institution, skin flora coverage is provided through preprocedural antibiotic administration as part of the routine UAE protocol to reduce the chance of postprocedural infection. In addition, the manufacturer’s suggestions of glove exchange, ample irrigation, and strict adherence to sterile technique have all been incorporated into our practice. Compared with the current literature, our complication rates were within the accepted ranges of 1.2%– 6% for minor complications (6 – 8) and 0 –1.0% for major complications (6,8,18) with use of the Closer S SMCD. The overall incidence of infection in the arteriotomy site is unknown. Diagnosis and management of these infections have been restricted to case reports and remain rare occurrences in the literature. This study has several important limitations. First, this was a prospective case series with no randomized arm. Because the database was primarily constructed to measure clinical outcomes and results, randomization of patients to SMCD and non-SMCD groups was not incorporated into its initial design. A prospective study that randomizes patients into SMCD versus manual compression treatment arms would be preferable. Second, the SMCD used for all attempts at devicemediated closure was from a single manufacturer, and as a result, the data collected may not be applicable to alternative methods of hemostasis, such as hemostatic patches (31), collagenmediated devices (32), or even other types of SMCDs (15). Third, long-term results are still pending, as the longest period of clinical observation has been only 3 years. Finally, no direct correlation between successful SMCD deployment and improved outcomes or increased patient satisfaction has been established. In conclusion, the standards of UAE have yet to be defined. Alternate models of pain management such as epidural patient-controlled analgesia have been instituted in our facilities, which would preclude the need for SMCD (as a result of the patient’s postprocedural immobility) and have shown promising results. The resources may not be available to all
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practices and settings. The data presented in this article suggest that suture-mediated closure of the primary arteriotomy in the UAE population is a safe and effective means of hemostasis. The presentation of anterior medial thigh pain is easily controlled by oral analgesics and may warrant inclusion into the SIR procedure-related complications. The fundamental question that remains is whether deployment of the SMCD results in better patient outcomes and satisfaction. References 1. Pinto I, Chimeno P, Romo A, et al. Uterine fibroids: uterine artery embolization versus abdominal hysterectomy for treatment—a prospective, randomized, and controlled clinical trial. Radiology 2003; 226:425– 431. 2. Klein A, Schwartz ML. Uterine artery embolization for the treatment of uterine fibroids: an outpatient procedure. Am J Obstet Gynecol 2001; 184:1556 – 1560. 3. Spies JB. Uterine artery embolization for fibroids: understanding the technical causes of failure. J Vasc Interv Radiol 2003; 14:11–14. 4. Pron G, Bennett J, Common A, Wall J, Asch M, Sniderman K. The Ontario Uterine Fibroid Embolization Trial. Part 2: uterine fibroid reduction and symptom relief after uterine artery embolization for fibroids. Fertil Steril 2003; 79:120 –127. 5. Wagner SC, Gonsalves CF, Eschelman DJ, Sullivan KL, Bonn J. Complications of a percutaneous suture-mediated closure device versus manual compression for arteriotomy closure: a case-controlled study. J Vasc Interv Radiol 2003; 14:735–741. 6. Duda SH, Wiskirchen J, Erb M, et al. Suture-mediated percutaneous closure of antegrade femoral arterial access sites in patients who have received full anticoagulation therapy. Radiology 1999; 210:47–52. 7. Baim DS, Knopf WD, Hinohara T, et al. Suture-mediated closure of the femoral access site after cardiac catheterization: results of the suture to ambulate and discharge (STAND I and STAND II) trials. Am J Cardiol 2000; 85:864 – 869. 8. Applegate RJ, Grabarczyk MA, Little WC, et al. Vascular closure devices in patients treated with anticoagulation
9. 10.
11.
12.
13. 14.
15. 16.
17.
18.
19.
20.
21.
and IIb/IIIa receptor inhibitors during percutaneous revascularization. J Am Coll Cardiol 2002; 40:78 – 83. Spies JB, Sacks D. Credentials for uterine artery embolization. J Vasc Interv Radiol 2004; 15:111–113. Omary RA, Bettmann MA, Cardella JF, et al. Quality improvement guidelines for the reporting and archiving of interventional radiology procedures. J Vasc Interv Radiol 2002; 13:879 – 881. Pelage JP, Le Dref O, Soyer P, et al. Fibroid-related menorrhagia: treatment with superselective embolization of the uterine arteries and midterm follow-up. Radiology 2000; 215:428 – 431. Spies JB, Scialli AR, Jha RC, et al. Initial results from uterine fibroid embolization for symptomatic leiomyomata. J Vasc Interv Radiol 1999; 10:1149 –1157. ACOG Committee Opinion. Uterine artery embolization. Obstet Gynecol 2004; 103:403– 404. Brunner MC, Durham JD, Lewis CA, McClenny TE. Strategic initiatives in interventional radiology: the clinical imperative. J Vasc Interv Radiol 2003; 14:1099 –1101. Hoffer EK, Bloch RD. Percutaneous arterial closure devices. J Vasc Interv Radiol 2003; 14:865– 885. Facchini FR. Percutaneous arterial access: redefining the possibilities using suture-mediated closure (Perclose). Tech Vasc Interv Radiol 2003; 6:72–75. Rinder MR, Tamirisa PK, Taniuchi M, Kurz HI, Mumm K, Lasala JM. Safety and efficacy of suture-mediated closure after percutaneous coronary interventions. Cathet Cardiovasc Interv 2001; 54:146 –151. Carey D, Martin JR, Moore CA, Valentine MC, Nygaard TW. Complications of femoral artery closure devices. Cathet Cardiovasc Interv 2001; 52:3–7. Starnes BW, O’Donnell SD, Gillespie DL, et al. Percutaneous arterial closure in peripheral vascular disease: a prospective randomized evaluation of the Perclose device. J Vasc Surg 2003; 38:263–271. Mackrell PJ, Kalbaugh CA, Langan EM III, et al. Can the Perclose suture-mediated closure system be used safely in patients undergoing diagnostic and therapeutic angiography to treat chronic lower extremity ischemia? J Vasc Surg 2003; 38:1305–1308. Brown DB, Crawford ST, Norton PL, Hovsepian DM. Angiographic follow-up after suture-mediated femoral
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23.
24.
25.
26.
27.
28.
29.
30.
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artery closure. J Vasc Interv Radiol 2002; 13:677– 680. Hallett JW Jr, Wolk SW, Cherry KJ Jr, Gloviczki P, Pairolero PC. The femoral neuralgia syndrome after arterial catheter trauma. J Vasc Surg 1990; 11: 702–706. Dias Filho LC, Valenca MM, Guimaraes Filho FA, et al. Lateral femoral cutaneous neuralgia: an anatomical insight. Clin Anat 2003; 16:309 –316. Pron G, Mocarski E, Bennett J, et al. Tolerance, hospital stay, and recovery after uterine artery embolization for fibroids: the Ontario Uterine Fibroid Embolization Trial. J Vasc Interv Radiol 2003; 14:1243–1250. Hofmann LV, Sood S, Liddell RP, et al. Arteriographic and pathologic evaluation of two suture-mediated arterial closure devices in a porcine model. J Vasc Interv Radiol 2003; 14:755–761. Heck DV, Muldowney S, McPherson SH. Infectious complications of Perclose for closure of femoral artery punctures. J Vasc Interv Radiol 2002; 13:430 – 431. Johanning JM, Franklin DP, Elmore JR, Han DC. Femoral artery infections associated with percutaneous arterial closure devices. J Vasc Surg 2001; 34: 983–985. Boston US, Panneton JM, Hofer JM, et al. Infectious and ischemic complications from percutaneous closure devices used after vascular access. Ann Vasc Surg 2003; 17:66 –71. Prabhudesai A, Khan MZ. An unusual cause of femoral embolism: Angioseal. Ann R Coll Surg Engl 2000; 82:355–356. Geary K, Landers JT, Fiore W, Riggs P. Management of infected femoral closure devices. Cardiovasc Surg 2002; 10: 161–163. Fischer TH, Connolly R, Thatte HS, Schwaitzberg SS. Comparison of structural and hemostatic properties of the poly-N-acetyl glucosamine Syvek Patch with products containing chitosan. Microsc Res Tech 2004; 63:168 – 174. Michalis LK, Rees MR, Patsouras D, et al. A prospective randomized trial comparing the safety and efficacy of three commercially available closure devices (Angioseal, Vasoseal and Duett). Cardiovasc Intervent Radiol 2002; 25:423– 429.
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Chrisman et al
Examination available at http://directory.sirweb.org/jvircme CME QUESTIONS 1) Advantages of SMCD usage over manual compression include all of the following EXCEPT: 䡬 䡬 䡬 䡬
a) b) c) d)
decreased time to ambulation shorter period of post procedural manual compression lower chance of post procedural embolization/infection less stringent post procedural observation at the groin puncture site
2) Contraindications for SMCD deployment include all of the following EXCEPT: 䡬 䡬 䡬 䡬
a) b) c) d)
prolonged procedure atherosclerotic disease major bifurcation within 1 cm of the arteriotomy thigh stenosis at or near the arteriotomy
3) The overall complication rate of 22% reported in this series: 䡬 䡬 䡬 䡬
a) b) c) d)
would dictate that the clinician should change to another method of hemostasis may be an overrepresentation of minor complications represents significant debilitation of the post-procedure patient is consistent with the current literature
4) Post SMCD anteromedial thigh pain may be managed by: 䡬 䡬 䡬 䡬
a) b) c) d)
open surgical resection of the SMCD deep massage over the arteriotomy site 2 week course of oral narcotics a short course of non steroidal anti-inflammatory medication
SIR JOURNAL CME PROGRAM The SIR Journal CME Program is a convenient way to fulfill your CME requirements while learning important information about the latest advances in medicine and research. Every other month, one article in the Journal of Vascular and Interventional Radiology (JVIR) will have a companion CME exam available online. SIR members are eligible to take the online exams at no cost; Non-Members can take the online exams for a $20.00 fee. New CME exams are available bi-monthly and will remain online for one year. Objectives After evaluating a specific article published in the Journal of Vascular and Interventional Radiology, participants in the SIR Journal CME Program should be able to • demonstrate an increase in, or affirmation of, their knowledge of clinical medicine and research. • evaluation the appropriateness of the clinical information as it applies to the provision of patient care. Participants This program is designed for interventional radiologists who are involved in providing patient care and who wish to advance their current knowledge of clinical medicine and research. Credits The Society of Interventional Radiology is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. The Society of Interventional Radiology designates this enduring activity for a maximum of 1.0 category 1 credits toward the AMA Physician’s Recognition Award.
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