Surgical complications from hemostatic puncture closure devices

BACKGROUND: For securing immediate hemostasis following percutaneous arterial catheterization, the Food and Drug Administration has approved three hemostatic puncture closure devices. We reviewed our institutional experience with one device (Angio-Seal). METHODS: A retrospective, single-center, nonrandomized observational study was made of all vascular complications following femoral cardiac catheterization. RESULTS: An immediate mechanical failure of the device was experienced in 34 (8%) patients. Surgical repair was required in 1.6% (7 of 425) of patients following Angio-Seal versus 0.3% (5 of 1662) following routine manual compression (P = 0.004). In 5 patients, the device caused either complete occlusion or stenosis of the femoral artery. The polymer anchor embolized in 1 patient and was retrieved with a balloon catheter at surgery. CONCLUSION: During the first year of utilization of a percutaneous hemostatic closure device following cardiac catheterization, we observed a marked increase in arterial occlusive complications requiring surgical repair. Surgeons must be familiar with the design of these devices to achieve precise repair of surgical complications.     

Management of acute lower limb ischemia associated with the Angio-Seal arterial puncture closing device

Arterial percutaneous closure devices (APCD) could lead to severe vascular complications, like acute lower limb ischemia. The aim of this study was to evaluate retrospectively our personal series of acute lower limb ischemia following the use of APCD. From January 2004 to June 2009 the Angio-Seal percutaneous closure devices was deployed in 198 patients. Eight (4%) acute lower limb ischemia required urgent surgical repair. The device was removed in all cases. A thromboembolectomy was performed in five patients (62.5%) and in three (37.5%) an endarterectomy with patch closure was carried out (two saphenous vein and one Dacron). Limb salvage rate was 87.5%. We compared Angio-Seal complications group (A) with the 190 patients in which the Angio-Seal was successfully used without complications (group B) by means of Student's t-test. At 36-month follow-up with color-coded duplex ultrasounds, no chronic limb ischemia or other complications requiring surgical repair occurred. Diabetes, obesity, severe femoral atherosclerotic involvement, use of sheath size >7 Fr and time-consuming procedures were significant risk factors for ischemic APCD complications. Despite vascular injuries being uncommon after APCD deployment, generally a complex surgical repair is necessary. A more careful patient selection would be advisable.     

Percutaneous closure devices for endovascular repair of infrarenal abdominal aortic aneurysms: a prospective, non-randomized comparative study.

PURPOSE: This study was designed to describe and evaluate our preliminary results with a percutaneous arterial closure device as compared to those obtained with conventional femoral surgical cut down during endovascular repair of abdominal aortic aneurysms (AAA). MATERIAL AND METHODS: Between January 2004 and December 2006, 40 of 86 AAA patients selected for endovascular repair met the criteria for inclusion in this study. Nineteen of these patients (Group A) received a bifurcated endograft placed by direct puncture of the femoral arteries (38 femoral triangles) with closure by a Prostar((R)) percutaneous arterial closure device (Abbott). The other 21 patients (control group B) were managed with a bifurcated endograft placed by conventional open surgery (42 femoral triangles). Data concerning all 40 patients were collected prospectively and analyzed. RESULTS: The technical success rate was 92% (group A) vs 90% (group B), P=0.79. The incidence of perioperative complications was 16% (3/19) in group A and 14% (3/21) in group B (P=0.89). The mean hospital stay was 5.8 days in group A and 7.8 days in group B (P=0.05). The difference in the length of hospitalisation was associated with reduced cost for the percutaneous group (5579.60 euros vs. 7503.60 euros; P=0.04), that counterbalanced the cost induced by the Prostar XL((R)) suture mediated device. Mean follow-up in both groups was 12 months. The overall incidence of locoregional complications after one year of follow-up was 11% (2/19) in group A and 19% (4/21) in group B (P=0.45). CONCLUSION: This study confirms the feasibility and safety of total percutaneous endovascular AAA repair. Our preliminary results suggest that the costs paid by healthcare providers for endovascular AAA repair might not be increased with the selective use of percutaneous closure devices.     

Infection is an unusual but serious complication of a femoral artery catheterization site closure device

Percutaneous devices have been developed to close the femoral artery puncture site after catheterization. Because direct compression is not needed, the devices save time for the treating health-care provider, reduce patient discomfort, and obviate the need for post-catheterization bed rest. Reported complications with use of these devices are similar in nature and frequency to those accompanying direct compression. Complications of infection requiring surgical treatment are exceedingly rare with use of these devices. We describe a series of five catheterization site infections occurring among 1807 patients (0.3%) whose femoral artery puncture was closed with a percutaneous suture closure device. All patients required operative intervention and there was one late death. Physicians should be aware of this uncommon but serious complication to expedite evaluation and treatment of patients with suspected infections from these devices.     

Femoral artery infection complicating intraaortic balloon pumping

Infection of the femoral artery (endarteritis) complicating intraaortic balloon pumping has not been reported. Most reports of complications with this pump have not emphasized wound infection. Whether the balloon is inserted by open or percutaneous technique, infection remains a problem. During the past 7 years, 32 of 50 patients (64 percent) who had intraaortic balloon pump insertion survived balloon removal. In four patients, wound infection of the groin developed with involvement of the femoral artery. Sepsis was due to P. aeruginosa in three patients and E. cloacae in one. All patients required variable degrees of resection of the infected femoral artery wall. One had successful arterial reconstruction with vein patch angioplasty alone after debridement of the vessel wall. In a second patient, resection of the common femoral artery with interposition of a saphenous vein that had been reconstructed to enhance its diameter to that of the femoral artery was accomplished. Dehiscence of a vein patch angioplasty occurred in the remaining two patients with resultant hemorrhage. Further resection of the femoral artery was required with femoro-femoral saphenous vein grafting in one patient and iliofemoral vein grafting in another. Tissue coverage of the reconstructed vessel was best accomplished using a tensor fascis lata myocutaneous flap. All patients survived the infection without amputation.     

Changing patterns of access site complications with the use of percutaneous closure devices.

The authors report their experience with 15 cases of groin complications associated with the use of percutaneous closure devices following femoral arterial catheterization over a 2-year period. The complication rate was 1.7% for catheterizations in which a closure device was used. The 15 cases included 7 uncomplicated pseudoaneurysms (PSA), 3 infected pseudoaneurysms, 4 nonarterial groin infections (infected hematomas and/or abscesses), and 1 case of femoral artery occlusion. These complications presented at an average of 5 +/- 4 days postcatheterization. One patient with an infected PSA required a below-the-knee amputation. During the same time interval, there were no infectious complications in patients not receiving closure devices. We conclude that groin complications associated with such devices tend to present late and include a higher percentage of infections as opposed to complications occurring in patients not receiving closure devices. An aggressive surgical approach to these problems appears warranted.     

Iatrogenic vascular injuries from percutaneous vascular suturing devices

OBJECTIVE: The purpose of this study was to examine the patterns of injury and the strategies of surgical repair of iatrogenic vascular injuries from a percutaneous vascular suturing device after arterial cannulation. METHODS: We retrospectively reviewed the clinical experience from an academic vascular surgical practice over a 2-year period. The subjects were patients undergoing vascular repair of iatrogenic vascular injury after deployment of a percutaneous vascular suturing device. Interventions were direct repair of arterial injury (with or without device extraction) or arterial thrombectomy and repair. The main outcome variables included patterns of arterial injury, magnitude of arterial repair, limb salvage, hospital stay, and perioperative mortality and morbidity rates. RESULTS: From August 1998 through August 2000, eight patients (4 men, 4 women; median age, 55 years; range, 44-80 years) required vascular operations for complications of percutaneous suturing devices after diagnostic (2) or therapeutic (6) arteriograms through a transfemoral approach. Complications included four pseudoaneurysms (1 infected) due to arterial tear from suture pull through, two entrapped closure devices due to device malfunction, and two arterial thromboses due to narrowing/severe intimal dissection. All patients required operative intervention. Direct suture repair with or without device removal was performed in five patients, arterial debridement with vein patch angioplasty in one patient, and arterial thrombectomy and vein patch angioplasty in two patients. There were no perioperative deaths. The median hospital stay was 5 days (range, 2-33). Limbs were salvaged in all patients with a mean follow-up of 4.8 months (range, 1-13). CONCLUSIONS: Although abbreviated postangiography recovery periods and early ambulation have motivated the widespread use of percutaneous suturing devices, the infrequent occurrence of vascular injuries produced by these devices can be significantly more challenging than simple acute pseudoaneurysms or hemorrhage. In addition, thrombotic complications have a small but finite risk of limb loss.     

Femoral artery infections associated with percutaneous arterial closure devices

Hemostasis obtained by manual compression after femoral artery catheterization results in consistently low rates of major complications. A rare complication of femoral artery catheterization is arterial infection. Its occurrence after diagnostic angiography using manual compression has not been reported. We report two cases of femoral arterial infection after uneventful diagnostic catheterization in nonimmunocompromised patients using the Perclose percutaneous arterial closure device. Our cases are representative of Perclose associated infections, with delayed presentation of a staphylococcal arterial infection requiring arterial debridement and reconstruction. This article indicates that Perclose use carries a risk of severe arterial infection. Surgeons should be aware of the potential infectious complications associated with Perclose use and the need for aggressive treatment.     

Management of Vascular Complications following Femoral Artery Catheterization with and without Percutaneous Arterial Closure Devices

Percutaneous arterial closure devices allow earlier mobilization and discharge of patients after arterial catheterization than with manual compression for puncture site hemostasis. We reviewed our recent experience managing the complications of femoral artery catheterization with and without these devices on the vascular surgery service at a tertiary hospital. Thirty-one patients presenting over an 18-month period with complications after femoral artery catheterization with manual compression (n = 21) or percutaneous arterial closure devices (n = 10) were retrospectively reviewed.     

Groin Infection Caused by a Percutaneous Femoral Artery Closure Device: Report of a Case

Hemostasis after femoral artery catheterization is generally achieved by manual compression, which results in a low incidence of infection at the puncture site. Percutaneous femoral artery closure devices have recently been used to prevent bleeding complications, shorten the hospital stay, and reduce the patient's discomfort. However, they have been associated with infectious complications, necessitating surgical intervention, such as patch angioplasty or arterial bypass; the treatment depending on the damage to the artery and the type of device used. Thus, the possibility of infection should be kept in mind when employing these devices. We report a case of groin infection associated with one such device, known as The Closer, which was successfully treated by drainage and removal of the suture material.     

Management of infected femoral closure devices

An increase in infectious complications has been noted with the introduction of percutaneous femoral artery closure devices. We report five cases of infected groins and/or femoral arteries following angiographic procedures that were completed using the Perclose Suture Mediated Closure Device (Perclose). Each patient required drainage of the abscess and removal of the Perclose suture. Most patients required more extensive vascular reconstructive procedures. When these complications arise, we recommend expeditious drainage of the abscess, removal of the suture, and adequate exposure of the femoral artery to facilitate repair of the vessel.     

Totally percutaneous aortic aneurysm repair: experience and prudence

OBJECTIVE: Totally percutaneous aortic aneurysm repair has been shown to be technically feasible, with low morbidity. Complications from percutaneous arterial closure are not insignificant, however, and can be fatal. We sought to evaluate our experience with this technique, compare it with the published literature, and identify factors associated with conversion to open repair and complications. METHODS: A retrospective review of a prospectively collected database was performed. All patients who underwent percutaneous closure of large-bore-sheath (>12F) access sites with off-label use of a suture-mediated closure device (Prostar XL) between December 2002 and August 2005 were reviewed. Outcome measures evaluated were rates of technical success, conversion to open femoral arterial repair, and complications. Axial diameter measurements of the accessed vessels were assessed with computed tomographic (CT) angiography both before and after the procedure. Patient variables were compared by using chi2, Fisher exact, and paired and independent samples t tests where appropriate. The mean follow-up interval was 1.5 years. RESULTS: During the study period, 49 patients underwent percutaneous closure of 79 large-bore-sheath access sites after successful endovascular aneurysm repair. Seven patients (14%) were morbidly obese (body mass index >35 kg/m2). Successful closure was achieved in 74 access sites (93.7%). Percutaneous closure was unsuccessful in five access sites (6.3%), all of which required open femoral repair at the same setting. Two converted patients experienced complications (4.1%): one retroperitoneal hematoma requiring transfusion of blood products and one iliac artery injury leading to death from myocardial infarction. Both of these patients were morbidly obese. Both complications occurred after closure of larger than 20F sheath sites. Morbid obesity and sheath size greater than 20F were associated with a significantly increased complication rate (P = .02 and P = .01, respectively). No thrombotic or infectious complications occurred in this series. Upon comparison of preoperative and postoperative CT angiograms, one (1.3%) small pseudoaneurysm was detected. No arteriovenous fistulas or hematomas larger than 3 cm were detected. The pseudoaneurysm occurred after closure of a 20F sheath access site. There were no significant differences in minimum intraluminal (7.38 +/- 1.8 vs 7.48 +/- 1.8) or maximum extraluminal (11.25 +/- 2.8 vs 12.02 +/- 2.7) diameters between preoperative and postoperative CT angiograms, respectively. CONCLUSIONS: Totally percutaneous aortic aneurysm repair is technically feasible in most cases, with no effect on the luminal diameter of the accessed femoral artery. Complications occur more often in morbidly obese patients and with sheaths larger than 20F. These complications can be minimized with meticulous technique and good patient selection. The capability for expeditious open femoral arterial repair is mandatory with this approach.     

完全穿刺技术在腹主动脉瘤腔内修复术中的应用

目的 探讨应用Perclose ProGlide缝合器完全穿刺技术行腹主动脉瘤腔内修复术的安全性和有效性.方法 2008年5月至2010年4月,36例腹主动脉瘤患者完全穿刺下行腔内修复术治疗.其中男性30例,女性6例;平均年龄68岁.所应用的支架型血管包括:3例Endurant,13例Talent,20例Zenith.18～24 F的鞘管预置两把ProGlide,14～16 F的鞘管预置单把ProGlide.缝合动脉切口时取出鞘管并将线结下滑收紧.统计技术成功率、相关并发症及手术操作时间.术后3、6、9、12个月及其后每年进行CT血管造影随访.结果 20例局部麻醉,16例全身麻醉.68条股动脉共应用128把ProGlide,其中38条股动脉各应用2把,8条各应用3把,2条各应用4把,20条各应用1把.63条股动脉(63/68,92.6%)技术操作成功,2条中转切开缝合,3条出现血肿,无需手术处理.平均随访时间(12±3)个月.1例于术后3个月出现无症状的动脉夹层.结论 完全穿刺技术在腹主动脉瘤腔内修复术中的应用是安全和有效的.由于可能需要切开缝合,建议在杂交手术室中操作.     

Lower limb ischemic complications after the use of arterial puncture closure devices.

We report three cases of lower limb ischemia occurring after the use of arterial puncture closure devices (APCDs). In two patients, who have undergone percutaneous angioplasty of lower limb arteries, the Angio-Seal APCD led to thrombosis of the common femoral artery. In another patient who has undergone coronary angiography, this device has led to dissection of the common femoral artery. Since these observations seem to not be merely sporadic, radiologists and cardiologists as well as vascular surgeons should be aware of their possible occurrence in order to avoid these complications and to provide promptly an adequate treatment.     

经皮冠状动脉介入治疗后血管缝合器 应用的方法学探讨

目的探讨缝合器止血的合理使用方法，提高操作成功率。方法使用美国ABOTT公司生产的percloser血管缝合器，对80例冠脉介入治疗后患者血管穿刺部位进行缝合止血，观察股动脉不同穿刺部位、多次介入治疗的股动脉以及股动脉造影的投照角度选择对缝合效果的影响。结果80例患者中76例缝合成功，成功率97．37％，2例失败，2例放弃缝合术。两种造影角度中，选择后前位法造影血管分支重叠64例(重叠率80％)，右前斜30。投照角度血管重叠8例(重叠率10％)。腹股沟上位点穿刺法50例，成功缝合49例，1例失败；腹股沟下位点缝合法30例，成功缝合27例，1例失败，2例放弃缝合术。结论应用percloser缝合器止血是一种安全有效的方法。观察穿刺部位的血管解剖关系时，右前斜30。可作为常规投照角度，穿刺点可优先选择腹股沟韧带上穿刺位点，其次选择腹股沟韧带下穿刺位点，对多次进行过介入治疗的股动脉不宜在重复部位行缝合治疗。     

Femoral artery occlusion with a percutaneous arterial closure device after a routine coronary angiogram: a case report and literature review

Groin vessels are most commonly used to obtain vascular access for angiography because of their size and accessibility. Haemostasis at the puncture site can be achieved with manual compression alone or by using a vascular closure device. We highlight the case of a 68-year-old woman who developed acute claudication in the right leg after a routine diagnostic coronary angiogram when an Angio-Seal(?) device had been employed to close a relatively low arterial puncture. On exploring the common femoral artery, fragments of the device were found occluding the bifurcation. A patch angioplasty was carried out and the patient's claudicant symptoms improved. The Angio-Seal(?) device has a polylactide and polyglycolide polymer anchor, a collagen plug and a suture contained within a carrier system. Haemostasis is achieved by compressing the arterial puncture site between the anchor and the collagen plug. The manufacturer's recommended criterion for using the device safely permits its use only for common femoral artery punctures with an internal vessel diameter of 4mm. Anatomical confirmation of the puncture site and evidence of any arterial disease or stenosis in the artery is detected on fluoroscopy during the procedure. Recent meta-analyses have cast doubt on the assumption that vascular closure devices are superior to mechanical compression alone and serious complications do occur occasionally but are under-reported. Clinicians should be aware of the potentially serious problems that may occur when deciding to employ vascular closure devices, especially with an anatomically low puncture site.     

Acute claudication caused by Angio-Seal closure devices: a report of four cases

Femoral artery closure devices are increasingly used after percutaneous arterial interventions to obtain hemostasis at the puncture site. Their efficacy and advantages in patient comfort are established. Nevertheless they can cause their own specific complications. In a five month's period we had to treat four patients with sudden onset invalidating claudication after the use of an Angio-Seal closure device. Malpositioning of the device led to the ischemic complications. We describe and illustrate the pre- and peroperative findings and the treatment. Interventionalists should monitor and register ischemic complications following the use of puncture site closure devices in order to try and minimize these. The occurrence of few serious complications can outweigh the relative small benefits these devices offer.     

Acute Claudication caused by Angio-Seal Closure Devices: a Report of Four Cases

Femoral artery closure devices are increasingly used after percutaneous arterial interventions to obtain hemo-stasis at the puncture site. Their efficacy and advantages in patient comfort are established. Nevertheless they can cause their own specific complications. In a five month’s period we had to treat four patients with sudden onset invalidating claudication after the use of an Angio-Seal closure device. Malpositioning of the device led to the ischemic complications. We describe and illustrate the pre-and peroperative findings and the treatment. Interventionalists should monitor and register ischemic complications following the use of puncture site closure devices in order to try and minimize these. The occurrence of few serious complications can outweigh the relative small benefits these devices offer.     

Ultrasound-guided access improves rate of access-related complications for totally percutaneous aortic aneurysm repair

Previous experience with totally percutaneous aortic aneurysm repair has identified morbid obesity and larger sheath sizes (> or =20F) as complicating factors for percutaneous access closure. We sought to evaluate the impact of ultrasound-guided femoral access on rates of technical success, conversion to open femoral repair, and access-related complications. A retrospective review of a prospectively maintained database was performed. All consecutive patients undergoing totally percutaneous closure of large-bore-sheath (>12F) access sites with a suture-mediated closure device were included. The cohort was stratified into two groups by access technique, standard percutaneous femoral access, and ultrasound-guided femoral access. Patient variables were evaluated, and outcome measures included technical success, requirement for conversion to open repair, and access-related complications. Recorded conversions only included those related to access closure technique. During the study period, 88 consecutive patients underwent percutaneous closure of 152 large-bore access sites after endovascular aneurysm repair. There was no difference in the proportion of morbidly obese patients (body mass index >35 kg/m(2)) between the two cohorts. Access-related complications were significantly reduced in the group undergoing ultrasound-guided access. Despite the lower complication profile with ultrasound guidance, 24 sites (41%) had sheath sizes > or =20F compared to only 21 sites (24%) in the standard access group (p<0.05). Evaluating conversions and technical success of percutaneous closure, a significant benefit was identified for sheath sizes > or =20F (p<0.05). Upon comparing the two cohorts, operative time continued to decrease from 154 (+/-64) to 101 (+/-56) min after the addition of ultrasound guidance for access (p<0.05). The addition of ultrasound-guided femoral access to totally percutaneous aortic aneurysm repair continues to increase the technical success rate for vessel closure and has a clinically profound impact on access-related complications. This technical adjunct appears to have the largest impact on patients requiring larger sheath sizes.     

Acute Leg Ischemia: The Dark Side of a Percutaneous Femoral Artery Closure Device

The use of femoral artery closure devices to obtain hemostasis after percutaneous catheterization has become widespread because of their proven feasibility in combination with patient-related advantages. Since 2002 more than 6,500 patients have undergone either diagnostic angiography or therapeutic intervention via the femoral route with an Angioseal closure device in our hospital. We were faced with six cases of limb-threatening complications, which are described here. Most (5/6) complications were of obstructive origin due to traumatic dissection or occlusion of the artery mainly caused by malpositioning of the device. Recommendations are made in order to prevent or successfully overcome this certainly increasing problem in the vascular field.