Surgical management of complications after transcatheter closure of an atrial septal defect or patent foramen ovale

OBJECTIVE: During recent years, transcatheter closure has become an alternative to operations for the treatment of atrial septal defects and patent foramen ovale. However, this procedure may be unsuccessful or complicated and requires surgical treatment. METHODS: We retrospectively analyzed the outcomes of patients who needed surgical treatment after failed or complicated transcatheter closure of an atrial septal defect or a patent foramen ovale. RESULTS: Between April 1994 and March 1999, 124 patients were treated with transcatheter closure of an atrial septal defect or a patent foramen ovale at our institution. We report the results of 10 (8%) patients of this series who required operations after transcatheter closure attempts. In 8 of these 10 patients a significant shunt caused by malposition or dislocation of the device persisted, leading to surgical closure of the defect. In 2 patients injury of the femoral artery at the puncture site required surgical repair. In one patient the device had to be removed surgically from the iliac vein after retraction. One patient died of left ventricular perforation after dislocation of the device and several surgical attempts to close the left ventricular rupture. All other patients recovered well. CONCLUSION: An operation was required after transcatheter closure of an atrial septal defect or a patent foramen ovale in 8% of patients. After device complications, the atrial septal defect and the patent foramen ovale can still successfully be closed surgically with good results and low morbidity. However, serious complications like cardiac perforation may have a fatal outcome. Residual shunt, dislocation, or vascular complications are the most frequent problems that require surgical interventions.     

Angiographic access site complications in the era of arterial closure devices

Coronary and peripheral angiography is associated with a low but significant risk of access site complications. While percutaneous devices have been shown to permit more rapid puncture site closure, previous reports have suggested the incidence and severity of complications associated with these devices are greater than with manual compression. This study compares access site complications with and without closure devices in the current era. The authors conducted a retrospective review of patients with access site complications after coronary or peripheral angiography between 1998 and 2000. Forty-five complications requiring vascular surgical consultation were identified in the 4,800 procedures performed during this time period. Fourteen complications occurred in 1,536 procedures (0.9%) using suture-mediated or collagen devices and 31 occurred in 3,264 procedures without devices (0.9%). The types of procedures and catheter sizes (mean 7 Fr) used were not different in the 2 groups. Other than complications involving a retained device, there was no difference between device and manual compression with respect to incidence or types of complication,requirement for operation, type of operation, or outcome. Access site complications identified included pseudoaneurysm (n = 22; 49%), bleeding or hematoma (n = 8;18%), arteriovenous fistula (n=5;11%), arterial thrombosis (n = 4;9%), infection (n = 4;9%), and retained device (n = 2;4%). Twenty-four patients (71% vs 45%; p = NS) required operative intervention including pseudoaneurysm repair, hematoma drainage, and thrombectomy. Eleven patients (26%) underwent successful ultra-sound-guided pseudoaneurysm compression and 9 patients (21%) required no intervention. These data demonstrate that closure devices facilitate arterial puncture site repair without an increase in access site complications. These devices can be safely utilized when rapid hemostasis is desired after coronary or peripheral angiography.     

Die Preclose-Technik zur perkutanen endovaskul?ren Therapie abdomineller und thorakaler Aortenaneurysmen

The percutaneous implantation of endografts for abdominal aortic aneurysms using the Preclose technique is a minimally invasive method with low soft tissue and vascular trauma at the access site compared to surgical cut-down. It has advantages concerning operative time and local wound complications. Risk factors for primary failure are low operator experience with the closure device, anterior wall calcification and severe fibrosis of the access vessel, whereas obesity and sheath size are not.     

Iatrogenic pseudoaneurysms of the peripheral arteries

The aim of the study was to report our clinical experience with the surgical treatment of iatrogenic pseudoaneurysms of the peripheral arteries. The study is a retrospective review of 101 consecutive patients (52 males, 49 females, mean age 66.2 years, range 33-86), with iatrogenic pseudoaneurysms of the peripheral arteries, surgically treated in a vascular unit from October 1990 to June 2006. Duplex ultrasound scanning was employed to support the clinical findings. The surgical treatment consisted in direct closure with polypropylene sutures and, occasionally, patch angioplasty or bypass. Ultrasound compression was effective in one of 4 small aneurysms (< 2.5). No limb loss occurred. There were 4 wound complications (3.9%), one pulmonary embolism (0.99%), and 3 deaths (2.9%), 2 of which not related to vascular repair and one secondary to femoral endoarteritis and septic shock, unrelated to previous implantation of a percutaneous femoral closure device. Although iatrogenic pseudoaneurysms of the peripheral arteries are rarely observed in clinical practice, a significant number of peripheral artery complications may occur after cardiac catheterisation and coronary angioplasty. Failure of conservative treatment requires a traditional surgical repair. The results of our series included a significant mortality rate (2.9%), resulting from the severity of cardiac disease in 2 cases and from the vascular repair itself in one case (femoral endoarteritis). These results substantiate the common observation that patients who require surgery for an iatrogenic pseudoaneurysm are often affected by advanced cardiovascular disease and are liable to suffer the occurrence of complications, with a high risk of death. Therefore, any surgical treatment should be performed with strict adherence to sound vascular surgical principles.     

Infectious and Ischemic Complications from Percutaneous Closure Devices Used after Vascular Access

The introduction of percutaneous closure devices (PCDs) to seal arteriotomy sites following percutaneous vascular access (PVA) can lead to greater complications than those with manual compression. The aim of this study was to compare complications and outcome between patients requiring surgery after receiving a PCD and those undergoing standard manual compression. This retrospective study evaluated 56 patients (mean age, 63 years) requiring surgical intervention from January 1, 1998 to April 30, 2002, following complications of PVA. Operative indications were pseudoaneurysm, hemorrhage, infectious complications, and limb ischemia. Patients were divided into two groups for comparison: group I (n = 15, PCD) and group II (n = 41, no PCD). In group 1 patients there were 18 limbs in which 20 Perclose devices were used and 1 limb in which a Duett device was used. From the outcomes in these two groups we concluded that patients undergoing surgical intervention following complications of PVA are at a significantly increased risk for infectious and ischemic complications and require more complex vascular repair when percutaneous closure devices are used.     

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.     

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.     

Implantable venous access device

Procedures for long-term angio access have for many years made up a major component of vascular surgical practice. A totally implantable vascular device for chronic venous access developed in the early '80s compares favorably with other methods of angio access. We implanted 76 of these devices in 73 patients on the oncology service of Fairview General Hospital between May 1984 and May 1986. The infusion ports were in place for a total of 14,509 patient days with a 3.9% rate of catheter related sepsis and 6.5% rate of catheter occlusion. Three occlusions resolved with streptokinase. Pocket infection occurred as a late complication in 3 patients. Emphasis is placed on a modified technique for device implantation. Strict adherence to a simplified percutaneous technique for the silastic catheter placement via the subclavian vein, with creation of the reservoir pocket after adequate vascular access is secure, has led to no serious complications during placement. Routine use of fluoroscopy during this procedure helped avoid potential technical complications. The advantages and disadvantages of the implantable systems compared to the dacron cuffed silastic catheters are discussed. Patient acceptance is excellent and improved cost/benefit ratio has been observed when compared to other forms of chronic venous access. Implantable vascular devices can be safely inserted with little morbidity or risk to the patient. They provide a convenient route for drawing blood, administering chemotherapy, hyperalimentation, and intravenous therapy in oncology patients and may represent an advantage over Hickman-Broviac catheters and the attendant catheter related sepsis associated with their use.     

Closure of carotid artery puncture site with a percutaneous device

The surgical treatment of traumatic neck injuries in patients with hostile anatomy is associated with higher risk of complications, due to the technical challenge and associated clinical conditions. The use of a percutaneous closure device for removal of a 7.5 Fr sheath, nonintentionally implanted into the carotid artery, is reported. The right common carotid sheath was removed after introducing a 0.035-inch guidewire; the Angioseal 8 Fr device was then introduced over the wire, successfully sealing the puncture site. Duplex scan control showed patency of the carotids, sealing of the puncture, and adequate flow in the jugular vein and carotid arteries. This maneuver allowed the safe placement of a percutaneous arterial device (Angioseal) to close the puncture site.     

Arterial thrombosis after using Angio-Seal

Percutaneous closure systems of arterial puncture sites are being used more and more in modern endovascular practice. In this article, we report five cases of thrombotic complications following Angio-Seal deployment which required to be treated in our department between June 2004 and January 2006. We carried out a computerized literature review using "vascular closure" as a keyword and elected 106 articles published between 1992 and 2007. The analysis of this literature review showed that the rate of percutaneous closure complications was similar to the rate of manual compression complications, which is still the reference method. The complications associated with the use of these systems were more complex and more often required surgical repair. The severity and frequency of these complications differ based on the type of closure systems. The vascular surgeon in charge must have a good knowledge of these systems and of the complications each of them entails to be able to treat them in the most appropriate way.     

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.     

Treatment of urinary incontinence with an artificial sphincter: further experience with the AS791/792 device

Artificial sphincter models AS791 and AS792 were used to treat 36 male and 7 female patients with urinary incontinence. Satisfactory results were obtained in 72 per cent of the patients. Of 100 surgical procedures performed to achieve these results 61 were planned procedures (initial implantation and delayed activation) and 39 were revisions required to improve continence, change mechanically failing devices or remove eroded sphincters. From our study 3 major problems with the artificial sphincter are apparent: 1) stress incontinence, which was present in 55 per cent of the patients with bulbous urethral sphincter compared to 21 per cent with sphincters located at the bladder neck, 2) erosions, which appear to be related to balloon pressure used and location of the artificial sphincter (there seems to be a higher incidence of erosions when the bulbous urethral site is used with balloon pressure greater than 80 cm. water) and 3) mechanical failures of the device, which accounted for 41 per cent of the unplanned operations in our series. These 3 major problems are reviewed, the possible etiology of persistent stress incontinence is discussed and possible ways to avoid these complications are suggested.     

Can the Perclose suture-mediated closure system be used safely in patients undergoing diagnostic and therapeutic angiography to treat chronic lower extremity ischemia?

PURPOSE: Mechanical closure devices for arterial hemostasis after angiography, such as the Perclose suture-mediated closure system, are designed to decrease time to ambulation and improve patient comfort. Although these devices are safe and efficacious, to date there has been little reported about use of the Perclose device in a cohort consisting exclusively of patients with lower extremity peripheral vascular disease. The purpose of this study was to determine the safety and efficacy of routine use of the Perclose system in patients with documented peripheral vascular disease undergoing angiography to treat chronic lower extremity ischemia. METHODS: The Perclose device was placed for arterial closure after femoral artery access in 500 consecutive patients with documented peripheral vascular disease (ankle-brachial index, <0.8) who underwent diagnostic angiography or percutaneous intervention because of chronic lower extremity ischemia. These 500 patients composed 91% of all patients who underwent angiography because of chronic lower extremity ischemia between January 1, 2001, and April 1, 2002. All complications associated with the Perclose device were identified and reviewed. RESULTS: Of the 500 arteries, 54% were accessed for diagnostic angiography and 46% for intervention. Perclose device placement was successful in 475 attempts (95%). Overall major complication rate was 1.4% (7 of 500 arteries). Complications included one death from retroperitoneal hemorrhage; three episodes of limb ischemia, two requiring operation and one requiring lytic therapy; two pseudoaneurysms; and one hematoma, which prolonged hospitalization. The hematoma was the only complication in the 25 patients with failed Perclose device placement. There were no infections requiring admission or operation. CONCLUSION: The Perclose suture-mediated closure device is efficacious and can be used safely in selected patients with documented peripheral vascular disease. Complications associated with this device tend to be more severe than those historically reported for manual compression. Substantial experience with use of this device is required to achieve excellent results in patients with difficult anatomy.     

Topical application of autologous blood products during surgical closure following a coronary artery bypass graft

OBJECTIVE: Surgical site wound complications are associated with increased cost, morbidity, and mortality following cardiothoracic surgery. Recent publications have advocated the application of autologous blood components as an adjunctive tool to surgical closure during various surgical procedures. The current study was intended to assess the safety and efficacy of the application of autologous platelet rich and platelet poor plasma to the sternal closure and saphenous vein harvest site during closure following a coronary artery bypass graft. PATIENTS AND METHODS: A retrospective analysis was performed on 1446 consecutive coronary artery bypass grafting procedures from two surgeons. A patient group receiving topical application of platelet rich and platelet poor plasma during closure of their chest and leg surgical incisions was compared to a patient population receiving standard treatment of care. Forty covariates were collected for each patient included in the study. Propensity scoring was used to adjust for baseline imbalance. Asymptotic logistic regression and exact statistical methods were used to determine the effect of the autologous blood application on infection and drainage of the sternal and leg wounds. RESULTS: One thousand, one hundred and twenty-eight patients had sufficient data to be included in the final analysis, with 571 of these patients receiving the treatment compared to 557 control patients. No treatment-related adverse events were noted and the application process did not significantly affect the operative time. CONCLUSION: This retrospective analysis of a consecutive series of patients receiving a coronary artery bypass grafting procedure concluded that application of platelet rich and platelet poor plasma significantly reduced occurrences of chest wound infection, chest drainage, and leg wound drainage. This novel therapy merits further investigation.     

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.     

LVAD as a bridge to decision complicated with pump thrombosis and infection

Left ventricular assist devices (LVADs) emerged as an effective therapy for the treatment of symptomatic advanced heart failure in spite of maximum tolerated optimal medical treatment. LVADs were initially conceived as a bridge to transplantation, although with the continuing donor shortage, they also serve as a definitive therapy for some patients. Careful evaluation by a multidisciplinary team and proper patient selection are key factors for good outcomes. These patients are very high-risk surgical candidates, and their survival at 1 year after implantation is estimated to be around 81%. We report a unique case of a patient who underwent LVAD implantation as a bridge to candidacy and suffered several complications related to the device. We also present our experience dealing with these complications in a field of limited evidence. This gentleman developed pump thrombosis second- ary to heparin-induced thrombocytopenia, requiring an LVAD exchange during index admission. A year after being discharged from the first episode, he developed mediastinitis, needing removal of the pump, intravenous antibiotics, and veno-arterial extra corporeal membrane oxygenation (VA-ECMO) for hemodynamic support. A new LVAD insertion was required, and the gentleman could be eventually discharged after a prolonged admission.     

Retrieval of embolized atrial septal defect closure device one year after insertion

Atrial Septal Defect (ASD) is one of the most common congenital cardiac defects and accounts for approximately 6–10 % of all congenital cardiac defects [1]. With the development of various devices, percutaneous transcatheter closure of ASD has become the first choice for selected patients. However, percutaneous transcatheter closure procedures are not free of potential complications. We report a case of a 14 year old female patient with embolized ASD closure device in Pulmonary Artery (PA) 1 year after insertion. She was treated with pulmonary arteriotomy, with retrieval of device and surgical closure of ASD.     

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.     

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.