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Complications of a Percutaneous Suture-mediated Closure Device versus Manual Compression for Arteriotomy Closure: A Case-controlled Study
Clinical Studies
Complications of a Percutaneous Suture-mediated Closure Device versus Manual Compression for Arteriotomy Closure: A Case-controlled Study Steven C. Wagner, MD, Carin F. Gonsalves, MD, David J. Eschelman, MD, Kevin L. Sullivan, MD, and Joseph Bonn, MD PURPOSE: To evaluate the incidence and types of complications encountered with use of a percutaneous suturemediated closure device versus manual compression for arteriotomy closure in a retrospective case-controlled study. MATERIALS AND METHODS: The authors identified 100 consecutive patients, 15 men and 85 women 21– 85 years of age (mean, 50 years), between December 2000 and July 2001 in whom the Closer percutaneous suture-mediated closure device was used during 65 uterine artery embolization (UAE) procedures, 11 hepatic chemoembolization procedures, nine diagnostic angiography procedures, seven peripheral vascular interventions, six visceral arterial interventions, and two thrombolysis procedures. An age-, sex-, and procedure-matched control population was identified in which manual compression was performed. Procedure reports and clinical charts were reviewed for the presence of puncture-site complications, as categorized according to Society of Interventional Radiology reporting standards, and for risk factors and comorbid conditions (hypertension, diabetes, stroke, smoking, and coronary artery disease). Follow-up visits and imaging studies were reviewed for patients with complications. RESULTS: In the Closer group, there were seven device failures, four minor complications, and three major complications. Minor complications included two groin hematomas and two cases of persistent pain at the arteriotomy site. Three major complications consisted of two cases of external iliac artery dissection, one with distal embolization, and one case of common femoral artery (CFA) occlusion and distal embolization. All major complications occurred in women undergoing UAE. One patient required thromboendarterectomy and patch angioplasty to repair the CFA occlusion, as well as amputation of a gangrenous toe. In the manual-compression group, there was one minor complication (a groin hematoma) and no major complications. There were significantly more complications in the Closer group than in the manual compression group (P ⴝ .02). CONCLUSIONS: Significantly more complications were associated with use of a percutaneous suture-mediated closure device than with manual compression for arteriotomy-site hemostasis. Major complications and associated morbidity may be seen with use of percutaneous suture-mediated closure devices. In particular, an unexpectedly high frequency of device-related complications was demonstrated in young women undergoing UAE. J Vasc Interv Radiol 2003; 14:735–741 Abbreviations:
ABI ⫽ ankle-brachial index, CAD ⫽ coronary artery disease, CFA ⫽ common femoral artery, UAE ⫽ uterine artery embolization
THE transfemoral approach is the most common route of percutaneous arterial access for diagnostic and interFrom the Division of Cardiovascular and Interventional Radiology, Thomas Jefferson University Hospital, Gibbon Building, Suite 4200, 111 South 11th Street, Philadelphia, Pennsylvania 19107. Received October 22, 2002; revision requested December 26; revision received January 29, 2003; accepted February 5. From the 2003 SIR Annual Meeting. Address correspondence to C.F.G.; E-mail: carin.gonsalves@mail. tju.edu None of the authors have identified a potential conflict of interest. © SIR, 2003 DOI: 10.1097/01.RVI.0000079982.80153.D9
ventional endovascular procedures. Complications associated with percutaneous femoral artery access may include hemorrhage, thrombosis, pseudoaneurysm, arteriovenous fistula, arterial dissection, distal embolization, and infection (1). Hemostasis at the arteriotomy site has conventionally been achieved by manual compression followed by a period of recumbency. Collagen plug devices and percutaneous suture-mediated arteriotomy closure devices have been developed to reduce time to hemostasis and ambulation, resulting in increased patient comfort and potentially earlier discharge from the hospital, without increasing complications (2–7).
As the use of suture-mediated closure devices has become more common, studies evaluating the initial experience with complications as well as puncture-site follow-up with Doppler ultrasound (US) and angiography have suggested initial and long-term safety (5–7). However, significant vascular complications with challenging surgical management have been reported (8,9). At our institution, we have experienced significant unexpected complications in otherwise healthy young patients with use of percutaneous suture-mediated closure devices. In particular, we noted major device-related complications in young
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women undergoing uterine artery embolization (UAE). Therefore, we sought to evaluate the incidence and types of complications encountered with use of percutaneous suture-mediated closure devices versus manual compression for arteriotomy closure after diagnostic and interventional procedures in a retrospective, casecontrolled study.
MATERIALS AND METHODS Patient Population After approval from our institutional review board for retrospective review of patient charts and reports, we performed a search of our electronic database to identify patients in whom percutaneous suture-mediated closure devices were used during an interventional radiology procedure. Our search yielded 100 consecutive patients from December 2000 to July 2001 in whom the Closer (Perclose, Redwood City, CA) percutaneous suture-mediated closure device was used for hemostasis of a common femoral arteriotomy. This group consisted of 15 men and 85 women, 21– 85 years of age, with a mean age of 50 years. The group had undergone a variety of procedures including 65 UAE procedures, 11 hepatic chemoembolization procedures, nine diagnostic angiography procedures, seven peripheral vascular interventions, six visceral arterial interventions, and two regional arterial thrombolysis procedures. The visceral and peripheral vascular interventions included percutaneous transluminal angioplasty, stent placement, or embolization. We searched the same database by procedure for patients who had undergone the same procedures listed in whom manual compression was used to achieve hemostasis of the femoral arteriotomy. Our search yielded 1,692 patients treated from January 1998 to January 2001 from whom we randomly selected a matched control population consisting of 15 men and 85 women 21– 86 years of age with a mean age of 50 years. Multiple variables were matched among the populations such that, for each patient in the Closer group, there was a patient in the manual compression group of the same sex, of the same age within 2 years, and undergoing the same procedure.
In each group, seven patients underwent systemic anticoagulation during their procedures. There were six splenic embolizations among the groups; in each case the platelet count ranged from 51,000 to 97,000 per microliter. Chart Review In each case, one author reviewed the patient clinical charts and noted the presence or absence of risk factors or comorbid conditions that may predispose to atherosclerosis and/or potentially place the patient at higher risk for complications at the arteriotomy site. Risk factors including a medical history significant for hypertension, diabetes mellitus, stroke, cigarette smoking, or coronary artery disease (CAD) were recorded for all patients. For each patient, the radiology procedure report and the clinical chart were reviewed by one author to determine the presence of any procedure complications, major or minor, among both groups, as well as device failures among the Closer group. We classified complications according to the two-tiered system adapted from the Society of Interventional Radiology reporting standards (10). Minor complications were defined as those requiring no or nominal therapy and without consequence, including overnight admission for observation only. Major complications were defined as those requiring therapy and hospitalization ⬍48 hours; those requiring major therapy, unplanned increase in level of care, or prolonged hospitalization ⬎48 hours; those with permanent adverse sequelae; and those resulting in death. Device failures were defined by persistent bleeding after deployment of the device, requiring subsequent manual compression. In cases in which complications occurred, the results of additional imaging and follow-up visits were reviewed to obtain clinical information. In our practice, all patients are evaluated by a physician before discharge from the hospital. Additionally, all patients undergoing UAE are seen routinely by a physician and physician assistant 1–2 weeks after the procedure. All procedure-related complications are recorded by our
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department’s performance improvement committee. Procedures All procedures were performed by one of five members of an experienced academic interventional radiology department certified by the manufacturer in the use of the Closer device. The Closer percutaneous suture-mediated closure device is a 6-F system that tracks over a standard 0.035-inch or 0.038-inch guide wire and uses one 3– 0 polyester suture and two needles to close a common femoral artery (CFA) puncture site. At our institution, this device was chosen for use predominately in those patients in whom the routine 6-hour recumbency period after manual compression would be difficult because of pain, as well as in patients who required continuous anticoagulation after a procedure. The 6-hour recumbency may be difficult in patients with procedurerelated pain such as after UAE or in those patients with severe back pain. The Closer was not used in patients with a small (⬍5 mm) CFA, hematoma before sheath removal, punctures of vascular grafts, antegrade punctures, fluoroscopically visible calcium within the CFA, or punctures of an artery other than the CFA. All procedures were performed via retrograde access to the CFA. Vascular sheaths used ranged from 4-F for UAE to 7-F for vascular interventions. At the end of the procedure, contrast material was injected via the access sheath to document (i) the location of the CFA puncture in relation to the CFA bifurcation, (ii) the CFA diameter, and (iii) that puncture site complications were not present before Closer device deployment. The puncture site was reprepared and redraped in sterile fashion and operators changed to new sterile gloves. The sheath or catheter was removed and the Closer device was placed over a 0.035-inch guide wire. The guide wire was removed when the exit port reached the level of the skin and the device was further advanced until continuous bleeding from the marker lumen confirmed appropriate intravascular positioning, at which point the foot plates were deployed within the vessel lumen. When the foot plates were adjacent to the arterial wall and an appro-
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Procedural Complications (N ⴝ 100) Perclose
Manual Compression
Procedure
Failures
Minor Complications
Major Complications
Minor Complications
Major Complications
UAE (n ⫽ 65) Chemoembolization (n ⫽ 11) Visceral intervention (n ⫽ 6) Peripheral intervention (n ⫽ 7) Diagnostic angiography (n ⫽ 9) Thrombolysis (n ⫽ 2) Total (%)
4 (6) 0 0 0 2 (22) 1 (50) 7
0 3 (27) 0 1 (14) 0 0 4
3 (5) 0 0 0 0 0 3
0 0 0 1 (14) 0 0 1
0 0 0 0 0 0 0
Note.—Values in parentheses are percentages.
priate angle of the device was obtained, the needles were deployed, removed from the plunger, and cut from the sutures. The foot plates were returned to their original position and the device was removed. The Clincher knot-tying device was used to secure the sutures and advance the knot through the subcutaneous tract to the arterial surface. When hemostasis was confirmed, the sutures were cut below the skin surface and sterile dressing was applied. Patients remained supine for 1 hour after the procedure. All patients with diabetes mellitus were given 1 g of cefazolin or, if penicillinallergic, 1 g of vancomycin intravenously before Closer device deployment. In our control group, the conventional method for hemostasis at the arteriotomy site was performed by manual compression for approximately 20 minutes or until hemostasis was obtained, followed by 6 hours of recumbency before ambulation. Statistical Analysis The McNemar test was used to assess for statistical differences in the total number of complications between the groups with use of a twotailed P value of ⬍.05 to define a significant difference. We also evaluated the similarity of the groups in terms of risk factors and comorbid conditions with use of the McNemar test to assess for any statistical differences in hypertension, stroke, diabetes mellitus, smoking, and CAD between the two groups. The Fisher exact test was used to evaluate for any statistical association between the individual risk factors and the presence of complications.
RESULTS Of the 100 patients in the Closer group, five had CAD, 26 had hypertension, six had diabetes mellitus, 44 had a history of tobacco use, and three had had a stroke. Of the 100 patients in the manual compression group, 10 patients had CAD, 36 had hypertension, seven had diabetes mellitus, 40 had a history of tobacco use, and one had had a stroke. Both groups had similar frequencies of risk factors and comorbid conditions such that the McNemar test with a two-tailed P value showed no significant difference between the groups in terms of CAD (P ⫽ .10), cigarette smoking (P ⫽ .58), hypertension (P ⫽ .10), diabetes mellitus (P ⫽ .76), and stroke (P ⫽ .56). The Table summarizes the number and types of complications encountered in each group. In the Closer group, there were seven device failures, four minor complications, and three major complications, whereas, in the manual compression group, there was one minor complication and no major complications (P ⫽ .02). There was no difference between the groups in terms of risk factors, and the Fisher exact test demonstrated no association between CAD (P ⫽ .53), hypertension (P ⫽ .15), diabetes mellitus (P ⫽ .58), cigarette smoking (P ⫽ .14), and stroke (P ⫽ .88) and the presence of complications. Of the seven device failures, all were cases of persistent bleeding from the site that required manual compression for hemostasis. Four failures occurred after UAE, two after lower extremity angiography, and one after common iliac artery thrombolysis and stent placement. Presumably, failures
were caused by inadequate apposition of the suture knot to the vessel wall. During a subsequent lower-extremity arterial bypass procedure in one of the patients in whom there was a device failure, the suture knot was identified in the subcutaneous tissues and adjacent to the CFA. In two cases, it was speculated that a large body habitus may have contributed to the device failure. There were no puncture-site infections in either group. The four minor complications in the Closer group consisted of two groin hematomas (6 –10 cm) and two cases of persistent pain at the arteriotomy site that began immediately after Closer deployment. Groin hematomas occurred after splenic embolization for thrombocytopenia in a patient with a platelet count of 86,000/L, and after hepatic chemoembolization. Both cases were managed conservatively without a transfusion or extension of hospitalization beyond an overnight observation, so they were classified as minor complications. Both hematomas spontaneously resolved without consequence on clinical follow-up. The two cases of immediate and persistent pain at the arteriotomy site occurred after hepatic chemoembolization procedures and were presumably related to adjacent nerve fibers being trapped in the sutures during deployment. In both cases, the pain completely resolved with nominal therapy and without further sequelae over a period of approximately 2 weeks, including 10 days of nonsteroidal antiinflammatory treatment. The three major complications in the Closer group consisted of two cases of arterial dissection, one with
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Figure 1. Selective pelvic arteriography (30° left anterior oblique view) demonstrates diffuse narrowing of the right external iliac artery representing dissection. Thrombus is seen proximal and distal to a severe focal stenosis of the distal external iliac artery (arrow).
distal embolization, and one case of arterial occlusion with distal embolization. These cases were defined as major complications because two patients required minor hospitalization and prolonged anticoagulation and the third patient required prolonged hospitalization with surgical intervention and permanent sequelae as described later. All major complications occurred after UAE procedures in young women without concomitant medical problems. The first case occurred in a 27-year-old woman with a medical history significant only for smoking, who had undergone UAE via the right common femoral artery with use of the Closer device for hemostasis. The patient presented 15 days after the procedure with symptoms of right thigh and calf claudication for 7 days. The ankle-brachial index (ABI) was found to be 0.53 on the right and 1.07 on the left. Arterial duplex Doppler examination showed decreased flow at the level of the junction of the common femoral and external iliac arteries. Subsequent arte-
riography demonstrated a dissection of the right external iliac artery with diffuse narrowing proximally and severe stenosis and thrombus involving the distal external iliac artery (Fig 1). The patient was administered an anticoagulation regimen, and the 3-month follow-up ABI on the right side was 0.82 and symptoms had improved. The second major complication occurred in a 49-year-old woman without significant medical history or risk factors. The patient had undergone UAE via the right common femoral artery with use of the Closer device. The patient presented 11 days after the procedure reporting right calf claudication for the previous 4 –5 days. The patient’s right common femoral artery pulse was diminished and the previously normal right dorsalis pedis pulse was absent. The right ABI was decreased at 0.74, with dampened pulse volume recordings, suggesting right external iliac artery stenosis. Subsequent angiography demonstrated dissection of the right external iliac artery with a 95% stenosis at the junction
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of the right external iliac and common femoral arteries (Fig 2). There was also abrupt occlusion of the anterior tibial artery at the level of the ankle mortise secondary to distal embolization. The patient was administered an anticoagulation regimen, and the 3-month follow-up ABI was 0.9 on the right side and symptoms had improved. The third major complication in the Closer group occurred in a 53-year-old woman with a medical history of hypertension and smoking who had undergone UAE via the left common femoral artery with use of the Closer device. The patient presented 11 days after the procedure with rest pain of the left foot and a blue great toe. On physical examination, there were nonpalpable dorsalis pedis and posterior tibial pulses with an ABI of 0.25. Subsequent arteriography demonstrated occlusion of the proximal left CFA with thrombus extending into the proximal superficial femoral and profunda femoris arteries (Fig 3a,b). Thromboendarterectomy and greater saphenous vein patch angioplasty were performed to repair the CFA occlusion. Dry gangrene developed in the left great toe that required amputation several months later. In the manual-compression group, there was only one minor complication and no major complications. The minor complication consisted of a 6-cm groin hematoma after percutaneous transluminal angioplasty of a profunda femoris artery stenosis. The hematoma resolved with conservative management and without further sequelae. None of the patients with groin hematomas required a blood transfusion in either group.
DISCUSSION Hemostasis at the arteriotomy site after diagnostic and interventional percutaneous endovascular procedures has traditionally been achieved by manual compression followed by a period of recumbency. The percutaneous suture-mediated closure device represents one of several attempts to develop a method to achieve arteriotomy hemostasis in a safe and timely manner, thereby reducing time to ambulation and discharge while decreasing patient discomfort. Several previous studies have shown the safety and efficacy of percutaneous suture-medi-
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Figure 2. Nonselective pelvic arteriography (30° left anterior oblique view) demonstrates a right external iliac artery dissection with a severe stenosis at the junction of the external iliac and common femoral arteries (arrow).
ated closure devices in decreasing time to hemostasis and time to ambulation without increasing access-site complications (2–7). However, recent experience suggests that access-site complications related to percutaneous suture-mediated closure devices may result in infrequent but significant and surgically challenging vascular complications such as arterial thromboses, infections, dissections, and large, noncompressible pseudoaneurysms that cannot be obliterated by US-guided compression (8,9,11). In our study, we found a 93% success rate with use of the percutaneous suture-mediated closure device, which is within the previously reported range of 91.2%–94.3% (2– 6,12). All seven failures in which there was persistent bleeding from the arteriotomy site went on to undergo manual compression without complication. Large body habitus was a suspected cause in two patients. There were no puncture-site infections in either group. Use of standard aseptic techniques in all cases and additional aseptic techniques along with a single dose of prophylactic intravenous antibiotics during placement of the percutaneous suture-mediated closure device in high-risk patients ap-
pears to prevent infectious complications. There were no cases requiring prolonged hospitalization. In our experience, the 7% overall complication rate with use of the Closer device was significantly higher than the 1% overall complication rate with use of manual compression. One puncture-site hematoma produced the 1% minor complication rate in the manual compression group. Our 7% overall complication rate in the Closer group was divided between 4% minor and 3% major complications. Our overall complication rate was similar to the 3.4%–7.0% rates reported by other authors (2,4,5,13). We also have shown no association between our complications and risk factors such as CAD, hypertension, smoking, diabetes mellitus, or stroke. Our minor complications consisted of two groin hematomas and two cases of prolonged pain at the puncture site, presumably caused by nerve entrapment by the sutures. Groin hematomas may be seen with any form of arteriotomy-site closure, although nerve entrapment may be unique to the percutaneous suture-mediated closure system. Our 4% minor complication rate in the Closer group was most similar that of Gerkens et al (5), who
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reported a 4.4% minor complication rate, and within the range of other authors reporting 2.8%–7.0% minor complication rates (2,4,13). Patients in the Closer group experienced a 3% major complication rate, higher than the 1.3% rate shown by Fram et al (4) in their group of 1,097 patients and 0.6% shown by Gerkens et al in their group of 298 patients undergoing cardiac catheterization (5). We also encountered a higher major complication rate than did Nehler et al (8), who reported a 0.3% major complication rate; eight of 3,000 patients required operative repair. However, similar to our major complications, their report included two cases of arterial thrombosis and intimal dissection. Likewise, an article on the surgical management of complications related to suture-mediated closure devices reported two cases of CFA thrombosis and one case of CFA dissection (9). All three of our major complications occurred after UAE procedures, which represented 65% of the total number of procedures. There were no immediate complications noted at the time of Closer device placement; however, all three patients presented clinically 11–15 after the procedure reporting claudication or rest pain and limb ischemia. The onset of symptoms appeared to correlate with the time when patients returned to their preprocedural levels of activity. The two cases of external iliac artery dissection occurred in 27- and 49-year-old patients, the latter also having distal embolization to the anterior tibial artery. Both patients were treated with systemic anticoagulation with interval improvement of symptoms and ABIs. The third patient was a 53-year-old woman in whom occlusion of the common femoral, proximal superficial femoral, and profunda femoris arteries with resultant limb ischemia developed. Subsequently, after surgical repair, the patient developed dry gangrene necessitating great-toe amputation. A recent report by Brown et al (12) on follow-up angiography in 30 patients with previous percutaneous suture-mediated closure device placement showed no change in vessel caliber in 90% of patients, with only 2 patients showing progression of preexisting atherosclerosis with stenosis
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Figure 3. (a) Pelvic arteriography (30° left anterior oblique view) demonstrates occlusion of the proximal left common femoral artery with thrombus extending into the proximal superficial and profunda femoral arteries. (b) Selective arteriogram (15° left anterior oblique view) of the left common femoral artery shows an occlusion of the common femoral artery (arrow) and proximal superficial femoral and profunda femoral arteries.
or occlusion at 5 and 12 months, respectively. Others have reported safety of the device at long-term follow-up (4,7,12), but our study showed early complications within 15 days after the procedure. These complications were likely the result of direct vessel injury occurring at the time of deployment of the Closer device. Additionally, the perivascular inflammatory response that has been shown after deployment may have been a contributing factor in our case of CFA thrombosis (8). As previously described, we found an unexpectedly high frequency of major complications in our population composed largely of young, otherwise healthy women undergoing UAE. Within this subset of our population, we had a 5% major complication rate (three of 65 patients). We have shown the complications to be related to device deployment, noting normal predeployment angiograms. The frequency of device-related arterial dissections and occlusions in nonatherosclerotic vessels was unexpected,
and we would have expected more complications in more-diseased vessels. This phenomenon may be partially related to sample-size bias, but potential mechanisms of injury may be proposed. For example, when comparing experience and literature on aortic dissections to our dissections, it has been noted that the site of injury in spontaneous aortic dissection, not including penetrating ulcers, is often free of atherosclerosis (14). It may be speculated that young women without vascular disease who have a more loose attachment between the intima and media may develop a dissection during Closer deployment as the foot plate is gently pulled into position adjacent to the arterial wall. Therefore, we have shown significantly more complications associated with use of a percutaneous suture-mediated closure device than with manual compression for arteriotomy-site hemostasis. Our study has shown a similar incidence of minor complications of these devices as reported pre-
viously by other authors. However, the incidence of major, symptomatic complications in otherwise normal patients was higher than suggested in other reports. Our study had a case-controlled design with age-, sex-, and procedurematched groups. However, the study design was retrospective, rather than prospective and randomized. Another potential limitation was our sample size. For example, sample-size bias may partially account for the high incidence of major complications in the patients undergoing UAE because they represented a majority of our sample population. However, to our knowledge, our study represents the only case-controlled study of puncture-site complications comparing percutaneous suture-mediated devices and manual compression. In summary, our experience demonstrates the potential morbidity that can result with use of percutaneous suture-mediated closure devices compared to manual compression for arte-
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riotomy-site hemostasis. New interventional endovascular procedures such as UAE are being performed in relatively young patients with few, if any, comorbidities. In this group of patients, the use of percutaneous suture-mediated closure devices may be an attractive means of providing improved patient comfort, especially during postprocedural periods of nausea, vomiting, severe pain, and difficulty urinating that may be partially ameliorated by the ability to sit upright and ambulate. However, our experience with percutaneous suturemediated closure devices shows that the potential for unexpected, significant arterial injury in young, otherwise healthy patients should be considered when selecting this method to achieve arteriotomy site hemostasis. References 1. Gardiner GA, Meyerovitz MF, Stokes KR, Clouse ME, Harrington DP, Bettmann MA. Complications of transluminal angioplasty. Radiology 1986; 159:201–208. 2. Balzer JO, Scheinert D, Diebold T, Haufe M, Vogl TJ, Biamino G. Postinterventional transcutaneous suture of femoral artery access sites in patients with peripheral arterial occlusive disease: A study of 930 patients.
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Cathet Cardiovasc Intervent 2001; 53: 174 –181. Carere RG, Webb JG, Ahmed T, Dodek AA. Initial experience using Prostar™: a new device for percutaneous suture-mediated closure of arterial puncture sites. Cath Cardiovasc Diagn 1996; 37:367–372. Fram DB, Giri S, Jamil G, et al. Suture closure of the femoral arteriotomy following invasive cardiac procedures: a detailed analysis of efficacy, complications, and the impact of early ambulation in 1,200 consecutive, unselected cases. Cath Cardiovasc Diagn 2001; 53: 163–173. Gerkens U, Cattelaens N, Lampe EG, Grube E. Management of arterial puncture site after catheterization procedures: evaluating a suture-mediated closure device. Am J Cardiol 1999; 83: 1658 –1663. Wetter DR, Rickli H, von Smekal A, Amann FW. Early sheath removal after coronary artery interventions with use of a suture-mediated closure device: clinical outcomes and results of Doppler US evaluation. J Vasc Interv Radiol 2000; 11:1033–1037. 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. Nehler MR, Lawrence A, Whitehill TA,
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Charette SD, Jones DN, Krupski WC. Iatrogenic vascular injuries from percutaneous vascular suturing devices. J Vasc Surg 2001; 33:943–947. Sprouse LR, Botta DM, Hamilton IN. The management of peripheral vascular complications associated with the use of percutaneous suture-mediated closure devices. J Vasc Surg 2001; 33: 688 – 693. Sacks D, Marinelli DL, Martin LG, et al. Reporting standard for clinical evaluation of new peripheral arterial revascularization devices. J Vasc Interv Radiol 1997; 8:137–149. Johanning JM, Franklin DP, Elmore JR, Han DC. Femoral artery infections associated with percutaneous arterial closure devices. J Vasc Surg 2001; 34: 983–985. Brown DB, Crawford ST, Norton PL, Hovsepian DM. Angiographic follow-up after suture-mediated femoral artery closure. J Vasc Interv Radiol 2002; 13:681– 687. 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. Khan IA, Nair CK. Clinical, diagnostic, and management perspectives of aortic dissection. Chest 2002; 122:311– 328.
Complications of a Percutaneous Suture-mediated Closure Device versus Manual Compression for Arteriotomy Closure: A Case-controlled Study Steven C. Wagner, MD, Carin F. Gonsalves, MD, David J. Eschelman, MD, Kevin L. Sullivan, MD, and Joseph Bonn, MD PURPOSE: To evaluate the incidence and types of complications encountered with use of a percutaneous suturemediated closure device versus manual compression for arteriotomy closure in a retrospective case-controlled study. MATERIALS AND METHODS: The authors identified 100 consecutive patients, 15 men and 85 women 21– 85 years of age (mean, 50 years), between December 2000 and July 2001 in whom the Closer percutaneous suture-mediated closure device was used during 65 uterine artery embolization (UAE) procedures, 11 hepatic chemoembolization procedures, nine diagnostic angiography procedures, seven peripheral vascular interventions, six visceral arterial interventions, and two thrombolysis procedures. An age-, sex-, and procedure-matched control population was identified in which manual compression was performed. Procedure reports and clinical charts were reviewed for the presence of puncture-site complications, as categorized according to Society of Interventional Radiology reporting standards, and for risk factors and comorbid conditions (hypertension, diabetes, stroke, smoking, and coronary artery disease). Follow-up visits and imaging studies were reviewed for patients with complications. RESULTS: In the Closer group, there were seven device failures, four minor complications, and three major complications. Minor complications included two groin hematomas and two cases of persistent pain at the arteriotomy site. Three major complications consisted of two cases of external iliac artery dissection, one with distal embolization, and one case of common femoral artery (CFA) occlusion and distal embolization. All major complications occurred in women undergoing UAE. One patient required thromboendarterectomy and patch angioplasty to repair the CFA occlusion, as well as amputation of a gangrenous toe. In the manual-compression group, there was one minor complication (a groin hematoma) and no major complications. There were significantly more complications in the Closer group than in the manual compression group (P ⴝ .02). CONCLUSIONS: Significantly more complications were associated with use of a percutaneous suture-mediated closure device than with manual compression for arteriotomy-site hemostasis. Major complications and associated morbidity may be seen with use of percutaneous suture-mediated closure devices. In particular, an unexpectedly high frequency of device-related complications was demonstrated in young women undergoing UAE. J Vasc Interv Radiol 2003; 14:735–741 Abbreviations:
ABI ⫽ ankle-brachial index, CAD ⫽ coronary artery disease, CFA ⫽ common femoral artery, UAE ⫽ uterine artery embolization
THE transfemoral approach is the most common route of percutaneous arterial access for diagnostic and interFrom the Division of Cardiovascular and Interventional Radiology, Thomas Jefferson University Hospital, Gibbon Building, Suite 4200, 111 South 11th Street, Philadelphia, Pennsylvania 19107. Received October 22, 2002; revision requested December 26; revision received January 29, 2003; accepted February 5. From the 2003 SIR Annual Meeting. Address correspondence to C.F.G.; E-mail: carin.gonsalves@mail. tju.edu None of the authors have identified a potential conflict of interest. © SIR, 2003 DOI: 10.1097/01.RVI.0000079982.80153.D9
ventional endovascular procedures. Complications associated with percutaneous femoral artery access may include hemorrhage, thrombosis, pseudoaneurysm, arteriovenous fistula, arterial dissection, distal embolization, and infection (1). Hemostasis at the arteriotomy site has conventionally been achieved by manual compression followed by a period of recumbency. Collagen plug devices and percutaneous suture-mediated arteriotomy closure devices have been developed to reduce time to hemostasis and ambulation, resulting in increased patient comfort and potentially earlier discharge from the hospital, without increasing complications (2–7).
As the use of suture-mediated closure devices has become more common, studies evaluating the initial experience with complications as well as puncture-site follow-up with Doppler ultrasound (US) and angiography have suggested initial and long-term safety (5–7). However, significant vascular complications with challenging surgical management have been reported (8,9). At our institution, we have experienced significant unexpected complications in otherwise healthy young patients with use of percutaneous suture-mediated closure devices. In particular, we noted major device-related complications in young
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women undergoing uterine artery embolization (UAE). Therefore, we sought to evaluate the incidence and types of complications encountered with use of percutaneous suture-mediated closure devices versus manual compression for arteriotomy closure after diagnostic and interventional procedures in a retrospective, casecontrolled study.
MATERIALS AND METHODS Patient Population After approval from our institutional review board for retrospective review of patient charts and reports, we performed a search of our electronic database to identify patients in whom percutaneous suture-mediated closure devices were used during an interventional radiology procedure. Our search yielded 100 consecutive patients from December 2000 to July 2001 in whom the Closer (Perclose, Redwood City, CA) percutaneous suture-mediated closure device was used for hemostasis of a common femoral arteriotomy. This group consisted of 15 men and 85 women, 21– 85 years of age, with a mean age of 50 years. The group had undergone a variety of procedures including 65 UAE procedures, 11 hepatic chemoembolization procedures, nine diagnostic angiography procedures, seven peripheral vascular interventions, six visceral arterial interventions, and two regional arterial thrombolysis procedures. The visceral and peripheral vascular interventions included percutaneous transluminal angioplasty, stent placement, or embolization. We searched the same database by procedure for patients who had undergone the same procedures listed in whom manual compression was used to achieve hemostasis of the femoral arteriotomy. Our search yielded 1,692 patients treated from January 1998 to January 2001 from whom we randomly selected a matched control population consisting of 15 men and 85 women 21– 86 years of age with a mean age of 50 years. Multiple variables were matched among the populations such that, for each patient in the Closer group, there was a patient in the manual compression group of the same sex, of the same age within 2 years, and undergoing the same procedure.
In each group, seven patients underwent systemic anticoagulation during their procedures. There were six splenic embolizations among the groups; in each case the platelet count ranged from 51,000 to 97,000 per microliter. Chart Review In each case, one author reviewed the patient clinical charts and noted the presence or absence of risk factors or comorbid conditions that may predispose to atherosclerosis and/or potentially place the patient at higher risk for complications at the arteriotomy site. Risk factors including a medical history significant for hypertension, diabetes mellitus, stroke, cigarette smoking, or coronary artery disease (CAD) were recorded for all patients. For each patient, the radiology procedure report and the clinical chart were reviewed by one author to determine the presence of any procedure complications, major or minor, among both groups, as well as device failures among the Closer group. We classified complications according to the two-tiered system adapted from the Society of Interventional Radiology reporting standards (10). Minor complications were defined as those requiring no or nominal therapy and without consequence, including overnight admission for observation only. Major complications were defined as those requiring therapy and hospitalization ⬍48 hours; those requiring major therapy, unplanned increase in level of care, or prolonged hospitalization ⬎48 hours; those with permanent adverse sequelae; and those resulting in death. Device failures were defined by persistent bleeding after deployment of the device, requiring subsequent manual compression. In cases in which complications occurred, the results of additional imaging and follow-up visits were reviewed to obtain clinical information. In our practice, all patients are evaluated by a physician before discharge from the hospital. Additionally, all patients undergoing UAE are seen routinely by a physician and physician assistant 1–2 weeks after the procedure. All procedure-related complications are recorded by our
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department’s performance improvement committee. Procedures All procedures were performed by one of five members of an experienced academic interventional radiology department certified by the manufacturer in the use of the Closer device. The Closer percutaneous suture-mediated closure device is a 6-F system that tracks over a standard 0.035-inch or 0.038-inch guide wire and uses one 3– 0 polyester suture and two needles to close a common femoral artery (CFA) puncture site. At our institution, this device was chosen for use predominately in those patients in whom the routine 6-hour recumbency period after manual compression would be difficult because of pain, as well as in patients who required continuous anticoagulation after a procedure. The 6-hour recumbency may be difficult in patients with procedurerelated pain such as after UAE or in those patients with severe back pain. The Closer was not used in patients with a small (⬍5 mm) CFA, hematoma before sheath removal, punctures of vascular grafts, antegrade punctures, fluoroscopically visible calcium within the CFA, or punctures of an artery other than the CFA. All procedures were performed via retrograde access to the CFA. Vascular sheaths used ranged from 4-F for UAE to 7-F for vascular interventions. At the end of the procedure, contrast material was injected via the access sheath to document (i) the location of the CFA puncture in relation to the CFA bifurcation, (ii) the CFA diameter, and (iii) that puncture site complications were not present before Closer device deployment. The puncture site was reprepared and redraped in sterile fashion and operators changed to new sterile gloves. The sheath or catheter was removed and the Closer device was placed over a 0.035-inch guide wire. The guide wire was removed when the exit port reached the level of the skin and the device was further advanced until continuous bleeding from the marker lumen confirmed appropriate intravascular positioning, at which point the foot plates were deployed within the vessel lumen. When the foot plates were adjacent to the arterial wall and an appro-
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Procedural Complications (N ⴝ 100) Perclose
Manual Compression
Procedure
Failures
Minor Complications
Major Complications
Minor Complications
Major Complications
UAE (n ⫽ 65) Chemoembolization (n ⫽ 11) Visceral intervention (n ⫽ 6) Peripheral intervention (n ⫽ 7) Diagnostic angiography (n ⫽ 9) Thrombolysis (n ⫽ 2) Total (%)
4 (6) 0 0 0 2 (22) 1 (50) 7
0 3 (27) 0 1 (14) 0 0 4
3 (5) 0 0 0 0 0 3
0 0 0 1 (14) 0 0 1
0 0 0 0 0 0 0
Note.—Values in parentheses are percentages.
priate angle of the device was obtained, the needles were deployed, removed from the plunger, and cut from the sutures. The foot plates were returned to their original position and the device was removed. The Clincher knot-tying device was used to secure the sutures and advance the knot through the subcutaneous tract to the arterial surface. When hemostasis was confirmed, the sutures were cut below the skin surface and sterile dressing was applied. Patients remained supine for 1 hour after the procedure. All patients with diabetes mellitus were given 1 g of cefazolin or, if penicillinallergic, 1 g of vancomycin intravenously before Closer device deployment. In our control group, the conventional method for hemostasis at the arteriotomy site was performed by manual compression for approximately 20 minutes or until hemostasis was obtained, followed by 6 hours of recumbency before ambulation. Statistical Analysis The McNemar test was used to assess for statistical differences in the total number of complications between the groups with use of a twotailed P value of ⬍.05 to define a significant difference. We also evaluated the similarity of the groups in terms of risk factors and comorbid conditions with use of the McNemar test to assess for any statistical differences in hypertension, stroke, diabetes mellitus, smoking, and CAD between the two groups. The Fisher exact test was used to evaluate for any statistical association between the individual risk factors and the presence of complications.
RESULTS Of the 100 patients in the Closer group, five had CAD, 26 had hypertension, six had diabetes mellitus, 44 had a history of tobacco use, and three had had a stroke. Of the 100 patients in the manual compression group, 10 patients had CAD, 36 had hypertension, seven had diabetes mellitus, 40 had a history of tobacco use, and one had had a stroke. Both groups had similar frequencies of risk factors and comorbid conditions such that the McNemar test with a two-tailed P value showed no significant difference between the groups in terms of CAD (P ⫽ .10), cigarette smoking (P ⫽ .58), hypertension (P ⫽ .10), diabetes mellitus (P ⫽ .76), and stroke (P ⫽ .56). The Table summarizes the number and types of complications encountered in each group. In the Closer group, there were seven device failures, four minor complications, and three major complications, whereas, in the manual compression group, there was one minor complication and no major complications (P ⫽ .02). There was no difference between the groups in terms of risk factors, and the Fisher exact test demonstrated no association between CAD (P ⫽ .53), hypertension (P ⫽ .15), diabetes mellitus (P ⫽ .58), cigarette smoking (P ⫽ .14), and stroke (P ⫽ .88) and the presence of complications. Of the seven device failures, all were cases of persistent bleeding from the site that required manual compression for hemostasis. Four failures occurred after UAE, two after lower extremity angiography, and one after common iliac artery thrombolysis and stent placement. Presumably, failures
were caused by inadequate apposition of the suture knot to the vessel wall. During a subsequent lower-extremity arterial bypass procedure in one of the patients in whom there was a device failure, the suture knot was identified in the subcutaneous tissues and adjacent to the CFA. In two cases, it was speculated that a large body habitus may have contributed to the device failure. There were no puncture-site infections in either group. The four minor complications in the Closer group consisted of two groin hematomas (6 –10 cm) and two cases of persistent pain at the arteriotomy site that began immediately after Closer deployment. Groin hematomas occurred after splenic embolization for thrombocytopenia in a patient with a platelet count of 86,000/L, and after hepatic chemoembolization. Both cases were managed conservatively without a transfusion or extension of hospitalization beyond an overnight observation, so they were classified as minor complications. Both hematomas spontaneously resolved without consequence on clinical follow-up. The two cases of immediate and persistent pain at the arteriotomy site occurred after hepatic chemoembolization procedures and were presumably related to adjacent nerve fibers being trapped in the sutures during deployment. In both cases, the pain completely resolved with nominal therapy and without further sequelae over a period of approximately 2 weeks, including 10 days of nonsteroidal antiinflammatory treatment. The three major complications in the Closer group consisted of two cases of arterial dissection, one with
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Figure 1. Selective pelvic arteriography (30° left anterior oblique view) demonstrates diffuse narrowing of the right external iliac artery representing dissection. Thrombus is seen proximal and distal to a severe focal stenosis of the distal external iliac artery (arrow).
distal embolization, and one case of arterial occlusion with distal embolization. These cases were defined as major complications because two patients required minor hospitalization and prolonged anticoagulation and the third patient required prolonged hospitalization with surgical intervention and permanent sequelae as described later. All major complications occurred after UAE procedures in young women without concomitant medical problems. The first case occurred in a 27-year-old woman with a medical history significant only for smoking, who had undergone UAE via the right common femoral artery with use of the Closer device for hemostasis. The patient presented 15 days after the procedure with symptoms of right thigh and calf claudication for 7 days. The ankle-brachial index (ABI) was found to be 0.53 on the right and 1.07 on the left. Arterial duplex Doppler examination showed decreased flow at the level of the junction of the common femoral and external iliac arteries. Subsequent arte-
riography demonstrated a dissection of the right external iliac artery with diffuse narrowing proximally and severe stenosis and thrombus involving the distal external iliac artery (Fig 1). The patient was administered an anticoagulation regimen, and the 3-month follow-up ABI on the right side was 0.82 and symptoms had improved. The second major complication occurred in a 49-year-old woman without significant medical history or risk factors. The patient had undergone UAE via the right common femoral artery with use of the Closer device. The patient presented 11 days after the procedure reporting right calf claudication for the previous 4 –5 days. The patient’s right common femoral artery pulse was diminished and the previously normal right dorsalis pedis pulse was absent. The right ABI was decreased at 0.74, with dampened pulse volume recordings, suggesting right external iliac artery stenosis. Subsequent angiography demonstrated dissection of the right external iliac artery with a 95% stenosis at the junction
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of the right external iliac and common femoral arteries (Fig 2). There was also abrupt occlusion of the anterior tibial artery at the level of the ankle mortise secondary to distal embolization. The patient was administered an anticoagulation regimen, and the 3-month follow-up ABI was 0.9 on the right side and symptoms had improved. The third major complication in the Closer group occurred in a 53-year-old woman with a medical history of hypertension and smoking who had undergone UAE via the left common femoral artery with use of the Closer device. The patient presented 11 days after the procedure with rest pain of the left foot and a blue great toe. On physical examination, there were nonpalpable dorsalis pedis and posterior tibial pulses with an ABI of 0.25. Subsequent arteriography demonstrated occlusion of the proximal left CFA with thrombus extending into the proximal superficial femoral and profunda femoris arteries (Fig 3a,b). Thromboendarterectomy and greater saphenous vein patch angioplasty were performed to repair the CFA occlusion. Dry gangrene developed in the left great toe that required amputation several months later. In the manual-compression group, there was only one minor complication and no major complications. The minor complication consisted of a 6-cm groin hematoma after percutaneous transluminal angioplasty of a profunda femoris artery stenosis. The hematoma resolved with conservative management and without further sequelae. None of the patients with groin hematomas required a blood transfusion in either group.
DISCUSSION Hemostasis at the arteriotomy site after diagnostic and interventional percutaneous endovascular procedures has traditionally been achieved by manual compression followed by a period of recumbency. The percutaneous suture-mediated closure device represents one of several attempts to develop a method to achieve arteriotomy hemostasis in a safe and timely manner, thereby reducing time to ambulation and discharge while decreasing patient discomfort. Several previous studies have shown the safety and efficacy of percutaneous suture-medi-
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Figure 2. Nonselective pelvic arteriography (30° left anterior oblique view) demonstrates a right external iliac artery dissection with a severe stenosis at the junction of the external iliac and common femoral arteries (arrow).
ated closure devices in decreasing time to hemostasis and time to ambulation without increasing access-site complications (2–7). However, recent experience suggests that access-site complications related to percutaneous suture-mediated closure devices may result in infrequent but significant and surgically challenging vascular complications such as arterial thromboses, infections, dissections, and large, noncompressible pseudoaneurysms that cannot be obliterated by US-guided compression (8,9,11). In our study, we found a 93% success rate with use of the percutaneous suture-mediated closure device, which is within the previously reported range of 91.2%–94.3% (2– 6,12). All seven failures in which there was persistent bleeding from the arteriotomy site went on to undergo manual compression without complication. Large body habitus was a suspected cause in two patients. There were no puncture-site infections in either group. Use of standard aseptic techniques in all cases and additional aseptic techniques along with a single dose of prophylactic intravenous antibiotics during placement of the percutaneous suture-mediated closure device in high-risk patients ap-
pears to prevent infectious complications. There were no cases requiring prolonged hospitalization. In our experience, the 7% overall complication rate with use of the Closer device was significantly higher than the 1% overall complication rate with use of manual compression. One puncture-site hematoma produced the 1% minor complication rate in the manual compression group. Our 7% overall complication rate in the Closer group was divided between 4% minor and 3% major complications. Our overall complication rate was similar to the 3.4%–7.0% rates reported by other authors (2,4,5,13). We also have shown no association between our complications and risk factors such as CAD, hypertension, smoking, diabetes mellitus, or stroke. Our minor complications consisted of two groin hematomas and two cases of prolonged pain at the puncture site, presumably caused by nerve entrapment by the sutures. Groin hematomas may be seen with any form of arteriotomy-site closure, although nerve entrapment may be unique to the percutaneous suture-mediated closure system. Our 4% minor complication rate in the Closer group was most similar that of Gerkens et al (5), who
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reported a 4.4% minor complication rate, and within the range of other authors reporting 2.8%–7.0% minor complication rates (2,4,13). Patients in the Closer group experienced a 3% major complication rate, higher than the 1.3% rate shown by Fram et al (4) in their group of 1,097 patients and 0.6% shown by Gerkens et al in their group of 298 patients undergoing cardiac catheterization (5). We also encountered a higher major complication rate than did Nehler et al (8), who reported a 0.3% major complication rate; eight of 3,000 patients required operative repair. However, similar to our major complications, their report included two cases of arterial thrombosis and intimal dissection. Likewise, an article on the surgical management of complications related to suture-mediated closure devices reported two cases of CFA thrombosis and one case of CFA dissection (9). All three of our major complications occurred after UAE procedures, which represented 65% of the total number of procedures. There were no immediate complications noted at the time of Closer device placement; however, all three patients presented clinically 11–15 after the procedure reporting claudication or rest pain and limb ischemia. The onset of symptoms appeared to correlate with the time when patients returned to their preprocedural levels of activity. The two cases of external iliac artery dissection occurred in 27- and 49-year-old patients, the latter also having distal embolization to the anterior tibial artery. Both patients were treated with systemic anticoagulation with interval improvement of symptoms and ABIs. The third patient was a 53-year-old woman in whom occlusion of the common femoral, proximal superficial femoral, and profunda femoris arteries with resultant limb ischemia developed. Subsequently, after surgical repair, the patient developed dry gangrene necessitating great-toe amputation. A recent report by Brown et al (12) on follow-up angiography in 30 patients with previous percutaneous suture-mediated closure device placement showed no change in vessel caliber in 90% of patients, with only 2 patients showing progression of preexisting atherosclerosis with stenosis
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Figure 3. (a) Pelvic arteriography (30° left anterior oblique view) demonstrates occlusion of the proximal left common femoral artery with thrombus extending into the proximal superficial and profunda femoral arteries. (b) Selective arteriogram (15° left anterior oblique view) of the left common femoral artery shows an occlusion of the common femoral artery (arrow) and proximal superficial femoral and profunda femoral arteries.
or occlusion at 5 and 12 months, respectively. Others have reported safety of the device at long-term follow-up (4,7,12), but our study showed early complications within 15 days after the procedure. These complications were likely the result of direct vessel injury occurring at the time of deployment of the Closer device. Additionally, the perivascular inflammatory response that has been shown after deployment may have been a contributing factor in our case of CFA thrombosis (8). As previously described, we found an unexpectedly high frequency of major complications in our population composed largely of young, otherwise healthy women undergoing UAE. Within this subset of our population, we had a 5% major complication rate (three of 65 patients). We have shown the complications to be related to device deployment, noting normal predeployment angiograms. The frequency of device-related arterial dissections and occlusions in nonatherosclerotic vessels was unexpected,
and we would have expected more complications in more-diseased vessels. This phenomenon may be partially related to sample-size bias, but potential mechanisms of injury may be proposed. For example, when comparing experience and literature on aortic dissections to our dissections, it has been noted that the site of injury in spontaneous aortic dissection, not including penetrating ulcers, is often free of atherosclerosis (14). It may be speculated that young women without vascular disease who have a more loose attachment between the intima and media may develop a dissection during Closer deployment as the foot plate is gently pulled into position adjacent to the arterial wall. Therefore, we have shown significantly more complications associated with use of a percutaneous suture-mediated closure device than with manual compression for arteriotomy-site hemostasis. Our study has shown a similar incidence of minor complications of these devices as reported pre-
viously by other authors. However, the incidence of major, symptomatic complications in otherwise normal patients was higher than suggested in other reports. Our study had a case-controlled design with age-, sex-, and procedurematched groups. However, the study design was retrospective, rather than prospective and randomized. Another potential limitation was our sample size. For example, sample-size bias may partially account for the high incidence of major complications in the patients undergoing UAE because they represented a majority of our sample population. However, to our knowledge, our study represents the only case-controlled study of puncture-site complications comparing percutaneous suture-mediated devices and manual compression. In summary, our experience demonstrates the potential morbidity that can result with use of percutaneous suture-mediated closure devices compared to manual compression for arte-
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riotomy-site hemostasis. New interventional endovascular procedures such as UAE are being performed in relatively young patients with few, if any, comorbidities. In this group of patients, the use of percutaneous suture-mediated closure devices may be an attractive means of providing improved patient comfort, especially during postprocedural periods of nausea, vomiting, severe pain, and difficulty urinating that may be partially ameliorated by the ability to sit upright and ambulate. However, our experience with percutaneous suturemediated closure devices shows that the potential for unexpected, significant arterial injury in young, otherwise healthy patients should be considered when selecting this method to achieve arteriotomy site hemostasis. References 1. Gardiner GA, Meyerovitz MF, Stokes KR, Clouse ME, Harrington DP, Bettmann MA. Complications of transluminal angioplasty. Radiology 1986; 159:201–208. 2. Balzer JO, Scheinert D, Diebold T, Haufe M, Vogl TJ, Biamino G. Postinterventional transcutaneous suture of femoral artery access sites in patients with peripheral arterial occlusive disease: A study of 930 patients.
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Cathet Cardiovasc Intervent 2001; 53: 174 –181. Carere RG, Webb JG, Ahmed T, Dodek AA. Initial experience using Prostar™: a new device for percutaneous suture-mediated closure of arterial puncture sites. Cath Cardiovasc Diagn 1996; 37:367–372. Fram DB, Giri S, Jamil G, et al. Suture closure of the femoral arteriotomy following invasive cardiac procedures: a detailed analysis of efficacy, complications, and the impact of early ambulation in 1,200 consecutive, unselected cases. Cath Cardiovasc Diagn 2001; 53: 163–173. Gerkens U, Cattelaens N, Lampe EG, Grube E. Management of arterial puncture site after catheterization procedures: evaluating a suture-mediated closure device. Am J Cardiol 1999; 83: 1658 –1663. Wetter DR, Rickli H, von Smekal A, Amann FW. Early sheath removal after coronary artery interventions with use of a suture-mediated closure device: clinical outcomes and results of Doppler US evaluation. J Vasc Interv Radiol 2000; 11:1033–1037. 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. Nehler MR, Lawrence A, Whitehill TA,
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Charette SD, Jones DN, Krupski WC. Iatrogenic vascular injuries from percutaneous vascular suturing devices. J Vasc Surg 2001; 33:943–947. Sprouse LR, Botta DM, Hamilton IN. The management of peripheral vascular complications associated with the use of percutaneous suture-mediated closure devices. J Vasc Surg 2001; 33: 688 – 693. Sacks D, Marinelli DL, Martin LG, et al. Reporting standard for clinical evaluation of new peripheral arterial revascularization devices. J Vasc Interv Radiol 1997; 8:137–149. Johanning JM, Franklin DP, Elmore JR, Han DC. Femoral artery infections associated with percutaneous arterial closure devices. J Vasc Surg 2001; 34: 983–985. Brown DB, Crawford ST, Norton PL, Hovsepian DM. Angiographic follow-up after suture-mediated femoral artery closure. J Vasc Interv Radiol 2002; 13:681– 687. 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. Khan IA, Nair CK. Clinical, diagnostic, and management perspectives of aortic dissection. Chest 2002; 122:311– 328.