- Email: [email protected]
Angiographic Follow-up after Suture-mediated Femoral Artery Closure
Angiographic Follow-up after Suture-mediated Femoral Artery Closure Daniel B. Brown, MD, Steven T. Crawford, MD, Patricia L. Norton, BA, RN, and David M. Hovsepian, MD
PURPOSE: Percutaneous closure devices are used in as many as 30% of all endovascular studies. Despite widespread use of these devices, only limited imaging has been performed after percutaneous closure. In this study, arteriograms of patients who had undergone suture-mediated closure with the Perclose device were reviewed. MATERIALS AND METHODS: Between June 1998 and November 2001, 31 patients who had previously undergone closure with use of the Perclose device at our institution returned for additional angiographic procedures. Twenty-one patients underwent closure with use of the Perclose device after embolization, including hepatic artery chemoembolization (n ⴝ 18), treatment of hypervascular sacral metastases (n ⴝ 2), and bronchial artery embolization (n ⴝ 1). Nineteen of these patients had thrombocytopenia. Ten patients underwent closure with use of the Perclose device after diagnosis and treatment of peripheral vascular disease. RESULTS: Of 31 patients, 28 had normal follow-up studies, including one patient who underwent four previous closures. These 28 patients all had normal femoral artery caliber at initial angiography and a platelet count of more than 18,000/mm3. Two patients with preexisting atherosclerotic change had progression of disease at the puncture site and a third with severe thrombocytopenia developed a small asymptomatic posterolateral pseudoaneurysm. CONCLUSION: In patients with normal femoral arteries, the long-term effects of closure with use of the Perclose device, even performed multiple times, appears to be minimal. Index terms:
Catheters and catheterization, complications
•
Femoral arteries, injuries
•
Percutaneous closure devices
J Vasc Interv Radiol 2002; 13:677– 680
PERCUTANEOUS closure devices can decrease time to hemostasis and ambulation after endovascular therapy (1–3). The Perclose device (Abbott, Redwood City, CA) is one such device. It has been shown to achieve hemostasis safely and with efficacy similar to that of manual compression (1,3– 4). However, there is only short-term imaging follow-up available for arteries that have undergone previous closure with the Perclose device; the longest follow-up for any study is 30 days and the imaging modality used was Doppler ultrasonography (US) (5).
From the Mallinckrodt Institute of Radiology, Washington University Medical Center, 510 South Kingshighway Boulevard, St. Louis, Missouri 63110. Received December 5, 2001; revision requested February 6, 2002; revision received March 7; accepted March 9. Address correspondence to D.B.B.; E-mail: [email protected] © SIR, 2002
There are several reasons why further follow-up after use of the Perclose device is desirable. First, a significant perivascular inflammatory response follows Perclose deployment, a fact first discovered during surgical exposure for vascular bypass procedures (6). Second, there is a potential for delayed complications after arteriography, even as long as 60 days after the procedure (7). Last, because many patients will return for repeat procedures, the potential effect of multiple uses of the Perclose device must be investigated. The purpose of this study was to evaluate the delayed angiographic appearance of the femoral artery after use of the Perclose device, with attention to those arteries undergoing multiple closures, and also to identify factors which may predispose to long-term complications, particularly underlying atherosclerosis or thrombocytopenia.
MATERIALS AND METHODS Between June 1998 and November 2001, 30 patients who had previously undergone closure with the Perclose device at our institution returned for additional angiographic procedures. These individuals comprised the study group. Perclose deployments were tracked via a prospective database and we reviewed each patient’s radiographic record after initial use of the device. The radiographs of patients who underwent repeat arteriography were reviewed. There were 24 men and six women with a mean age of 58 years. The indication for initial angiography was broken down into two broad categories. The first group (n ⫽ 21) underwent Perclose closure after embolization, including hepatic artery chemoembolization (n ⫽ 18), treatment of hypervascular sacral metastases (n ⫽ 2), or bronchial artery embolization (n ⫽ 1). The indications for use of the Perclose device in this group
677
678
•
Angiography after Suture-mediated Puncture Site Closure
July 2002
JVIR
Figure 1. (a) Initial angiography in a 76-year-old man with left buttock and thigh claudication. The left iliac occlusion was crossed and a stent was positioned from a right groin approach. Twelve months later, he presented with gradually increasing right thigh claudication and arteriography was performed from the left groin (b). Progression of disease is noted at and around the puncture site at follow-up angiography.
were thrombocytopenia (⬍80,000 platelets/mm3; n ⫽ 19) or inability to lie flat after catheter removal (n ⫽ 2). No patient in this group had a history of peripheral vascular disease. The second group (n ⫽ 9) underwent Perclose closure after diagnosis and treatment of peripheral vascular disease, including heparinization during stent placement or thrombolysis (n ⫽ 8) or an inability to lie flat after angiography (n ⫽ 1). All nine patients in this group had peripheral vascular disease. No patient in this group had a previous bypass graft in the site in which the Perclose device was deployed. Imaging of the arterial access site before Perclose closure was performed routinely to document the condition of the common femoral artery and avoid complications related to variant anatomy (8). The number of suture-mediated closures for each patient was noted, as was the follow-up time from
initial deployment of the Perclose device to repeat arteriography. Changes in vessel caliber were quantified by visual comparison of the access site by two readers (D.B.B., S.T.C.), with a third reader (D.M.H.) available in the event of conflicting opinions. Caliber change was classified as follows: pseudoaneurysm formation, no change, ⬍50% diminution in caliber, ⬎50% diminution in caliber, or vessel occlusion. Complications associated with the procedures and Perclose device deployment were followed according to Society of Cardiovascular & Interventional Radiology reporting standards for diagnostic arteriography (9).
RESULTS Perclose device deployment was attempted 63 times in 30 patients (mean, 2.1; range, 1– 6) and was successful 58 times (92%). The 6-F device was used
in all patients after use of 7-F (n ⫽ 15) or 6-F (n ⫽ 48) sheaths. All Perclose device deployment failures were caused by suture breakage or “air knot” (inadequate apposition of the suture to the vessel wall). Hemostasis was obtained in all device failures by manual compression. No major or minor complications resulted after deployment failure or immediately after successful device deployment. The Perclose device was used once in nine patients, twice in 14 patients, three times in five patients, and five and six times in one patient each. The mean and median durations of angiographic follow-up were 8.5 and 6 months (range, 1–36 mo). The common femoral artery access site was normal in the initial study in 28 of 30 patients (93%), with ⬍50% narrowing in two of the patients who underwent angiography for evaluation and treatment of peripheral vas-
Volume 13
Number 7
Brown et al
All other closure sites (90% of the study population and 96% of those with normal common femoral arteries at initial angiography) remained normal at follow-up without development of stenosis or pseudoaneurysm.
DISCUSSION
Figure 2. Common femoral artery injection in a 75-year-old man with thrombocytopenia who was treated with chemoembolization for hepatocellular carcinoma. The Perclose device was used six times over a 3-year period without technical failure. Imaging at 10° left anterior oblique reveals a small posterolateral pseudoaneurysm.
cular disease. At follow-up, 27 patients (90% of the study population and 96% of those with normal initial vascular caliber) had no change at follow-up and no evidence of stenosis or pseudoaneurysm formation. The two patients with preexisting atherosclerosis (7% of the study population and 100% of those with abnormal common femoral arteries on initial angiography) had progression of disease after a single Perclose device deployment. Occlusion and ⬎50% diminution in caliber were found 12 and 5 months, respectively, after the initial study (Fig 1). Both patients presented with worsening thigh and calf claudication ipsilateral to the closure site; however, both also had progression of disease at sites remote from the femoral arteriotomy. In patients with normal-caliber arteries at initial angiography, the only change was development of a small (approximately 9 mm) posterolateral pseudoaneurysm (Fig 2) after previous double-wall puncture in a patient with thrombocytopenia (18,000 platelets per mm3). Of note, no failures occurred in five previous closures in this patient. This lesion is being followed clinically.
Use of arterial closure devices has rapidly expanded since their introduction. It is estimated that some type of closure device is now used in as many as 30% of all femoral artery catheterizations (1). Regardless of indications for use of the Perclose device, many patients have the potential to return for repeat studies given the natural tendency for progression of disease. Previous reports have documented the initial success of the use of the Perclose device and summarized the immediate complications related to use of these devices. It is known that as many as 2% of patients undergoing percutaneous closure may require acute surgical repair of the access site (10). The surgical complications after treatment of Perclose device failure impart greater morbidity than those after manual compression. The adverse outcomes from use of the Perclose device may be related to the inflammation that presumably results from a foreign-body reaction elicited by the suture. The inflammatory response makes surgical exposure more difficult and results in larger pseudoaneurysms, greater blood loss, and a higher frequency of transfusion than in surgical repair of a pseudoaneurysm that develops after manual compression alone (6 – 7,11). One of the advantages of use of the Perclose device is the ability to reaccess the same artery without delay. Although repeat arteriograms were obtained in earlier studies (2–3), the time to repeat puncture and long-term effects on the arteries were not addressed. Balzer et al (5) performed Doppler US within a month of performing arterial interventions, but previous femoral punctures were an exclusion criterion to their retrospective trial. Patients in our study with platelet counts greater than 18,000/mm3 and normal vascular diameter had no caliber changes even after multiple closures or even failure of the Perclose device to achieve adequate hemostasis. The two patients with progression
•
679
of femoral artery disease also had advancement of atherosclerosis elsewhere that almost certainly contributed to their presenting symptoms. The delay in onset of symptoms, which is of greater duration than any previously reported long-term complication of use of the Perclose device (60 d), supports this argument. The presence of calcification in the common femoral artery, in the absence of stenosis, would also represent significant atherosclerotic disease and use of the Perclose device would again be contraindicated. Some previous trials have excluded suture-mediated closure in the setting of coagulopathy (3) or anticoagulation with glycoprotein IIa/IIIb inhibitors (12). Our group consisted of 19 patients with known cirrhosis who had initial platelet counts of less than 80,000/mm3. Attempts at closure were successful in 40 of 45 attempts in this group, with none of the failures related to “bleeding through” successful deployment. The patient who developed a small pseudoaneurysm had successful closure after all six embolization procedures. Our success with higher-risk patients mirrors that of Resnic et al (4). Their closure group had significantly fewer pseudoaneurysms and hematomas with the Perclose device than with manual compression after coronary interventions supplemented with glycoprotein IIb/ IIIa inhibitors. In light of these experiences, we believe that coagulopathy in a patient who requires angiography should be maximally treated. After treatment, use of the Perclose device is appropriate and indicated at completion of angiography. Potential weaknesses of our study include the small sample size and the heterogeneity of the patient population. Despite these limitations, we believe that, in patients with normal femoral arteries, the long-term effects of use of the Perclose device—even multiple times—appear to be minimal and that these patients can undergo multiple closures without risk of arterial compromise. The use of this device in individuals with preexisting atherosclerotic disease at the femoral puncture site is a cause for concern. Further investigation regarding use of the Perclose device in this situation is warranted.
680
•
July 2002
Angiography after Suture-mediated Puncture Site Closure
References 1. 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. 2. 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 outcome and results of Doppler US evaluation. J Vasc Interv Radiol 2000; 11:1033–1037. 3. Gerckens 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. 4. Resnic FS, Blake GJ, Ohno-Machado L, Selwyn AP, Popma JJ, Rogers C. Vascular closure devices and the risk of complications after percutaneous coro-
5.
6.
7.
8.
nary intervention in patients receiving glycoprotein IIb-IIIa inhibitors. Am J Cardiol 2001; 88:493– 496. 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. Cathet Cardiovasc Intervent 2001; 53:174–181. Nehler MR, Lawrence AW, Whitehill TA, 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. Rinder MR, Tamirisa PK, Taniuchi M, Kurz HI, Mumm K, Lasala JM. Safety and efficacy of suture-mediated closure after percutaneous coronary inter-
9.
10.
11.
12.
JVIR
ventions. Cathet Cardiovasc Intervent 2001; 54:146 –151. Singh H, Cardella JF, Cole PE, et al. Quality improvement guidelines for diagnostic arteriography. J Vasc Interv Radiol 2002; 13:1– 6. Dangas G, Mehran R, Kokolis S, et al. Vascular complications after percutaneous coronary interventions following hemostasis with manual compression versus arteriotomy closure devices. J Am Coll Cardiol 2001; 38:638– 641. Gonze MD, Sternbergh C, Salartash K, Money SR. Complications associated with percutaneous closure devices. Am J Surg 1999; 178:209 –211. Duffin DC, Muhlestein JB, Allisson SB, Horne BD, Fowles RE. Femoral artery puncture management after percutaneous coronary procedures: a comparison of clinical outcomes and patient satisfaction between manual compression and two different vascular closure devices. J Invasive Cardiol 2001; 13:354 –362.
Retraction of Article The authors named below have requested retraction of the following article: Fontaine AB, Borsa JJ, Hoffer EJ, Bloch RD, So C. Stent placement in the treatment of pulmonary artery stenosis secondary to fibrosing mediastinitis. J Vasc Interv Radiol 2001; 12:1107–1111.
PURPOSE: Percutaneous closure devices are used in as many as 30% of all endovascular studies. Despite widespread use of these devices, only limited imaging has been performed after percutaneous closure. In this study, arteriograms of patients who had undergone suture-mediated closure with the Perclose device were reviewed. MATERIALS AND METHODS: Between June 1998 and November 2001, 31 patients who had previously undergone closure with use of the Perclose device at our institution returned for additional angiographic procedures. Twenty-one patients underwent closure with use of the Perclose device after embolization, including hepatic artery chemoembolization (n ⴝ 18), treatment of hypervascular sacral metastases (n ⴝ 2), and bronchial artery embolization (n ⴝ 1). Nineteen of these patients had thrombocytopenia. Ten patients underwent closure with use of the Perclose device after diagnosis and treatment of peripheral vascular disease. RESULTS: Of 31 patients, 28 had normal follow-up studies, including one patient who underwent four previous closures. These 28 patients all had normal femoral artery caliber at initial angiography and a platelet count of more than 18,000/mm3. Two patients with preexisting atherosclerotic change had progression of disease at the puncture site and a third with severe thrombocytopenia developed a small asymptomatic posterolateral pseudoaneurysm. CONCLUSION: In patients with normal femoral arteries, the long-term effects of closure with use of the Perclose device, even performed multiple times, appears to be minimal. Index terms:
Catheters and catheterization, complications
•
Femoral arteries, injuries
•
Percutaneous closure devices
J Vasc Interv Radiol 2002; 13:677– 680
PERCUTANEOUS closure devices can decrease time to hemostasis and ambulation after endovascular therapy (1–3). The Perclose device (Abbott, Redwood City, CA) is one such device. It has been shown to achieve hemostasis safely and with efficacy similar to that of manual compression (1,3– 4). However, there is only short-term imaging follow-up available for arteries that have undergone previous closure with the Perclose device; the longest follow-up for any study is 30 days and the imaging modality used was Doppler ultrasonography (US) (5).
From the Mallinckrodt Institute of Radiology, Washington University Medical Center, 510 South Kingshighway Boulevard, St. Louis, Missouri 63110. Received December 5, 2001; revision requested February 6, 2002; revision received March 7; accepted March 9. Address correspondence to D.B.B.; E-mail: [email protected] © SIR, 2002
There are several reasons why further follow-up after use of the Perclose device is desirable. First, a significant perivascular inflammatory response follows Perclose deployment, a fact first discovered during surgical exposure for vascular bypass procedures (6). Second, there is a potential for delayed complications after arteriography, even as long as 60 days after the procedure (7). Last, because many patients will return for repeat procedures, the potential effect of multiple uses of the Perclose device must be investigated. The purpose of this study was to evaluate the delayed angiographic appearance of the femoral artery after use of the Perclose device, with attention to those arteries undergoing multiple closures, and also to identify factors which may predispose to long-term complications, particularly underlying atherosclerosis or thrombocytopenia.
MATERIALS AND METHODS Between June 1998 and November 2001, 30 patients who had previously undergone closure with the Perclose device at our institution returned for additional angiographic procedures. These individuals comprised the study group. Perclose deployments were tracked via a prospective database and we reviewed each patient’s radiographic record after initial use of the device. The radiographs of patients who underwent repeat arteriography were reviewed. There were 24 men and six women with a mean age of 58 years. The indication for initial angiography was broken down into two broad categories. The first group (n ⫽ 21) underwent Perclose closure after embolization, including hepatic artery chemoembolization (n ⫽ 18), treatment of hypervascular sacral metastases (n ⫽ 2), or bronchial artery embolization (n ⫽ 1). The indications for use of the Perclose device in this group
677
678
•
Angiography after Suture-mediated Puncture Site Closure
July 2002
JVIR
Figure 1. (a) Initial angiography in a 76-year-old man with left buttock and thigh claudication. The left iliac occlusion was crossed and a stent was positioned from a right groin approach. Twelve months later, he presented with gradually increasing right thigh claudication and arteriography was performed from the left groin (b). Progression of disease is noted at and around the puncture site at follow-up angiography.
were thrombocytopenia (⬍80,000 platelets/mm3; n ⫽ 19) or inability to lie flat after catheter removal (n ⫽ 2). No patient in this group had a history of peripheral vascular disease. The second group (n ⫽ 9) underwent Perclose closure after diagnosis and treatment of peripheral vascular disease, including heparinization during stent placement or thrombolysis (n ⫽ 8) or an inability to lie flat after angiography (n ⫽ 1). All nine patients in this group had peripheral vascular disease. No patient in this group had a previous bypass graft in the site in which the Perclose device was deployed. Imaging of the arterial access site before Perclose closure was performed routinely to document the condition of the common femoral artery and avoid complications related to variant anatomy (8). The number of suture-mediated closures for each patient was noted, as was the follow-up time from
initial deployment of the Perclose device to repeat arteriography. Changes in vessel caliber were quantified by visual comparison of the access site by two readers (D.B.B., S.T.C.), with a third reader (D.M.H.) available in the event of conflicting opinions. Caliber change was classified as follows: pseudoaneurysm formation, no change, ⬍50% diminution in caliber, ⬎50% diminution in caliber, or vessel occlusion. Complications associated with the procedures and Perclose device deployment were followed according to Society of Cardiovascular & Interventional Radiology reporting standards for diagnostic arteriography (9).
RESULTS Perclose device deployment was attempted 63 times in 30 patients (mean, 2.1; range, 1– 6) and was successful 58 times (92%). The 6-F device was used
in all patients after use of 7-F (n ⫽ 15) or 6-F (n ⫽ 48) sheaths. All Perclose device deployment failures were caused by suture breakage or “air knot” (inadequate apposition of the suture to the vessel wall). Hemostasis was obtained in all device failures by manual compression. No major or minor complications resulted after deployment failure or immediately after successful device deployment. The Perclose device was used once in nine patients, twice in 14 patients, three times in five patients, and five and six times in one patient each. The mean and median durations of angiographic follow-up were 8.5 and 6 months (range, 1–36 mo). The common femoral artery access site was normal in the initial study in 28 of 30 patients (93%), with ⬍50% narrowing in two of the patients who underwent angiography for evaluation and treatment of peripheral vas-
Volume 13
Number 7
Brown et al
All other closure sites (90% of the study population and 96% of those with normal common femoral arteries at initial angiography) remained normal at follow-up without development of stenosis or pseudoaneurysm.
DISCUSSION
Figure 2. Common femoral artery injection in a 75-year-old man with thrombocytopenia who was treated with chemoembolization for hepatocellular carcinoma. The Perclose device was used six times over a 3-year period without technical failure. Imaging at 10° left anterior oblique reveals a small posterolateral pseudoaneurysm.
cular disease. At follow-up, 27 patients (90% of the study population and 96% of those with normal initial vascular caliber) had no change at follow-up and no evidence of stenosis or pseudoaneurysm formation. The two patients with preexisting atherosclerosis (7% of the study population and 100% of those with abnormal common femoral arteries on initial angiography) had progression of disease after a single Perclose device deployment. Occlusion and ⬎50% diminution in caliber were found 12 and 5 months, respectively, after the initial study (Fig 1). Both patients presented with worsening thigh and calf claudication ipsilateral to the closure site; however, both also had progression of disease at sites remote from the femoral arteriotomy. In patients with normal-caliber arteries at initial angiography, the only change was development of a small (approximately 9 mm) posterolateral pseudoaneurysm (Fig 2) after previous double-wall puncture in a patient with thrombocytopenia (18,000 platelets per mm3). Of note, no failures occurred in five previous closures in this patient. This lesion is being followed clinically.
Use of arterial closure devices has rapidly expanded since their introduction. It is estimated that some type of closure device is now used in as many as 30% of all femoral artery catheterizations (1). Regardless of indications for use of the Perclose device, many patients have the potential to return for repeat studies given the natural tendency for progression of disease. Previous reports have documented the initial success of the use of the Perclose device and summarized the immediate complications related to use of these devices. It is known that as many as 2% of patients undergoing percutaneous closure may require acute surgical repair of the access site (10). The surgical complications after treatment of Perclose device failure impart greater morbidity than those after manual compression. The adverse outcomes from use of the Perclose device may be related to the inflammation that presumably results from a foreign-body reaction elicited by the suture. The inflammatory response makes surgical exposure more difficult and results in larger pseudoaneurysms, greater blood loss, and a higher frequency of transfusion than in surgical repair of a pseudoaneurysm that develops after manual compression alone (6 – 7,11). One of the advantages of use of the Perclose device is the ability to reaccess the same artery without delay. Although repeat arteriograms were obtained in earlier studies (2–3), the time to repeat puncture and long-term effects on the arteries were not addressed. Balzer et al (5) performed Doppler US within a month of performing arterial interventions, but previous femoral punctures were an exclusion criterion to their retrospective trial. Patients in our study with platelet counts greater than 18,000/mm3 and normal vascular diameter had no caliber changes even after multiple closures or even failure of the Perclose device to achieve adequate hemostasis. The two patients with progression
•
679
of femoral artery disease also had advancement of atherosclerosis elsewhere that almost certainly contributed to their presenting symptoms. The delay in onset of symptoms, which is of greater duration than any previously reported long-term complication of use of the Perclose device (60 d), supports this argument. The presence of calcification in the common femoral artery, in the absence of stenosis, would also represent significant atherosclerotic disease and use of the Perclose device would again be contraindicated. Some previous trials have excluded suture-mediated closure in the setting of coagulopathy (3) or anticoagulation with glycoprotein IIa/IIIb inhibitors (12). Our group consisted of 19 patients with known cirrhosis who had initial platelet counts of less than 80,000/mm3. Attempts at closure were successful in 40 of 45 attempts in this group, with none of the failures related to “bleeding through” successful deployment. The patient who developed a small pseudoaneurysm had successful closure after all six embolization procedures. Our success with higher-risk patients mirrors that of Resnic et al (4). Their closure group had significantly fewer pseudoaneurysms and hematomas with the Perclose device than with manual compression after coronary interventions supplemented with glycoprotein IIb/ IIIa inhibitors. In light of these experiences, we believe that coagulopathy in a patient who requires angiography should be maximally treated. After treatment, use of the Perclose device is appropriate and indicated at completion of angiography. Potential weaknesses of our study include the small sample size and the heterogeneity of the patient population. Despite these limitations, we believe that, in patients with normal femoral arteries, the long-term effects of use of the Perclose device—even multiple times—appear to be minimal and that these patients can undergo multiple closures without risk of arterial compromise. The use of this device in individuals with preexisting atherosclerotic disease at the femoral puncture site is a cause for concern. Further investigation regarding use of the Perclose device in this situation is warranted.
680
•
July 2002
Angiography after Suture-mediated Puncture Site Closure
References 1. 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. 2. 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 outcome and results of Doppler US evaluation. J Vasc Interv Radiol 2000; 11:1033–1037. 3. Gerckens 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. 4. Resnic FS, Blake GJ, Ohno-Machado L, Selwyn AP, Popma JJ, Rogers C. Vascular closure devices and the risk of complications after percutaneous coro-
5.
6.
7.
8.
nary intervention in patients receiving glycoprotein IIb-IIIa inhibitors. Am J Cardiol 2001; 88:493– 496. 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. Cathet Cardiovasc Intervent 2001; 53:174–181. Nehler MR, Lawrence AW, Whitehill TA, 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. Rinder MR, Tamirisa PK, Taniuchi M, Kurz HI, Mumm K, Lasala JM. Safety and efficacy of suture-mediated closure after percutaneous coronary inter-
9.
10.
11.
12.
JVIR
ventions. Cathet Cardiovasc Intervent 2001; 54:146 –151. Singh H, Cardella JF, Cole PE, et al. Quality improvement guidelines for diagnostic arteriography. J Vasc Interv Radiol 2002; 13:1– 6. Dangas G, Mehran R, Kokolis S, et al. Vascular complications after percutaneous coronary interventions following hemostasis with manual compression versus arteriotomy closure devices. J Am Coll Cardiol 2001; 38:638– 641. Gonze MD, Sternbergh C, Salartash K, Money SR. Complications associated with percutaneous closure devices. Am J Surg 1999; 178:209 –211. Duffin DC, Muhlestein JB, Allisson SB, Horne BD, Fowles RE. Femoral artery puncture management after percutaneous coronary procedures: a comparison of clinical outcomes and patient satisfaction between manual compression and two different vascular closure devices. J Invasive Cardiol 2001; 13:354 –362.
Retraction of Article The authors named below have requested retraction of the following article: Fontaine AB, Borsa JJ, Hoffer EJ, Bloch RD, So C. Stent placement in the treatment of pulmonary artery stenosis secondary to fibrosing mediastinitis. J Vasc Interv Radiol 2001; 12:1107–1111.