Comparison of closure strategies after balloon aortic valvuloplasty: Suture mediated versus collagen based versus manual

Objectives : To compare complication rates of a collagen‐mediated closure device, suture‐mediated closure technique and manual compression for access site management following balloon aortic valvuloplasty (BAV). Background : Vascular complications, including perforation, limb ischemia, ateriovenous fistulas, and pseudoaneurysm, are a common source of morbidity in patients undergoing BAV with large bore femoral artery access. The available options for closure of the access site include manual compression, suture‐mediated closure devices, and recently reported collagen‐based closure devices. Methods : The study cohort consisted of 333 patients with severe aortic stenosis undergoing BAV. Patients were divided into four groups according to access closure method: (1) Manual compression in 64 (19.2%); (2) Proglide 6 Fr in 162 (48.6%); (3) Angio‐Seal 8 Fr in 89 (26.75%); and (4) Prostar 10 Fr in18 (5.4%). Results : There were no significant differences in baseline characteristics among the groups; although the Prostar group was had more males and the Angio‐Seal group reported a lower incidence of renal failure and peripheral vascular disease. The Angio‐Seal group had shorter procedural duration times compared with the other groups. In the Angio‐Seal group (n = 47, 52.8%), a 10 Fr sheath size was primarily used to access the femoral artery, as compared with the manual compression and Proglide groups, which used a 12 Fr sheath in 29 (45.3%) and 66 patients (40.7%), respectively. A 13 Fr sheath was used in the Prostar group (n = 11, 61.1%), P < 0.001. The device failure rate was significantly higher in the Proglide group (n = 20, 12.3%) as compared with Angio‐Seal (n = 3, 3.3%) and Prostar groups (n = 1, 5.5%), P = 0.03. Serious vascular complications requiring intervention were significantly higher in the manual compression group (n = 11, 17.1%) compared with the Proglide (n = 11, 6.7%), Angio‐Seal (n = 5, 5.6%), and Prostar groups (n = 5, 1%), P < 0.001. The requirement for blood transfusion in the Angio‐Seal group was significantly lower (n = 7, 7.8%) as compared with the manual compression (n = 20, 31.2%), Proglide (n = 35, 21.6%), and Prostar groups (n = 5, 27.7%), P < 0.001. Conclusion : In our case series, collagen‐based closure devices and suture‐mediated closure devices had fewer vascular complications than manual compression for hemostasis following BAV. Patient selection for collagen‐based versus suture‐mediated closure requires further study. © 2011 Wiley‐Liss, Inc.     

A modified “Preclosure” technique after percutaneous aortic valve replacement

Objectives: To evaluate the feasibility, safety and efficacy of suture‐mediated closure devices using a modified “preclosure” technique for access site management after percutaneous aortic valve replacement (PAVR). Background: PAVR using a retrograde transfemoral approach has recently evolved to an endovascular alternative to open surgery in high‐risk patients. However, large‐bore femoral artery access is required, commonly demanding surgical closure and general anesthesia. A truly percutaneous intervention would be desirable to reduce procedural complexity and diminish the need of vascular surgery and general anaesthesia. Methods: After direct puncture of the common femoral artery, three conventional suture‐mediated closure devices (6F Perclose) were deployed. The preloaded sutures were tied at the end of the procedure. If no immediate hemostasis was achieved, an additional device was deployed thereafter. Results: PAVR with percutaneous access site closure was attempted in 15 consecutive patients and could successfully be achieved in all patients allowing conscious sedation in all but three cases. Following complications occurred: one retroperitoneal bleeding caused by removal of the valve delivery sheath requiring surgical repair, as well as two cases of femoral and iliac artery dissection caused by delivery sheath introduction and treated by stenting and vascular surgery, respectively. Vascular surgery became only necessary due to total vessel occlusion after suture closure and remains the only closure‐related complication. However, treatment led to recovery in all patients. Conclusions: The modified “preclosure” technique is a feasible and safe method for hemostasis after PAVR improving procedural management and diminishing the need for general anesthesia. © 2008 Wiley‐Liss, Inc.     

Limitations of closing percutaneous transthoracic ventricular access ports using a commercial collagen vascular closure device

Introduction : Closed‐chest access and closure of direct cardiac punctures may enable a range of therapeutic procedures. We evaluate the safety and feasibility of closing percutaneous direct ventricular access sites using a commercial collagen‐based femoral artery closure device. Methods : Yorkshire swine underwent percutaneous transthoracic left ventricular access (n = 13). The access port was closed using a commercial collagen‐based vascular closure device (Angio‐Seal, St. Jude Medical) with or without prior separation of the pericardial layers by instillation of fluid into the pericardial space (“permissive pericardial tamponade”). After initial nonsurvival feasibility experiments (n = 6); animals underwent 1‐week (n = 3) or 6‐week follow‐up (n = 4). Results : In naïve animals, the collagen plug tended to deploy outside the parietal pericardium, where it failed to accomplish hemostasis. “Permissive pericardial tamponade” was created under MRI, and accomplished early hemostasis by allowing the collagen sponge to seat on the epicardial surface inside the pericardium. After successful closure, six of seven animals accumulated a large pericardial effusion 5 ± 1 days after closure. Despite percutaneous drainage during 6‐week follow‐up, the large pericardial effusion recurred in half, and was lethal in one. Conclusions : A commercial collagen‐based vascular closure device may achieve temporary but not durable hemostasis when closing a direct left ventricular puncture port, but only after intentional pericardial separation. These insights may contribute to development of a superior device solution. Elective clinical application of this device to close apical access ports should be avoided. © 2011 Wiley‐Liss, Inc.     

Access site management after aortic valvuloplasty using a suture mediated closure device: clinical experience in 4 cases

Management of the femoral access site following percutaneous balloon aortic valvuloplasty is often associated with significant vascular morbidity. In an effort to reduce vascular complications, a novel method of suture mediated closure device deployment was employed in four patients that underwent aortic valvuloplasty at our institution. Delivery of the sutures to the access site took place prior to the intervention in all patients. This pre-close technique allowed the sutures to be placed utilizing the 10 French (Fr) closure device prior to expanding the access site to a 14 Fr size. This was done to facilitate adequate tissue capture, thereby assuring successful hemostasis following sheath removal. The technique was successful in all patients and none of the patients suffered vascular complications. This new access site management method was successful in achieving hemostasis and provided improved patient recovery in this small group of patients as compared to our usual experience.     

A randomized trial comparing compression,perclose proglide™ and Angio‐Seal VIP™ for arterial closure following percutaneous coronary intervention: The cap trial

Objective: This prospective randomized trial compared the Angio‐Seal VIP? with Perclose Proglide? and to manual compression with respect to time to hemostasis and ambulation, patient satisfaction, and vascular complications following percutaneous coronary intervention (PCI). Background: The use of arterial closure devices for the reduction of vascular complications following PCI remains controversial. There have been no head to head trials comparing these most commonly used arterial closure devices following PCI. Methods: Two hundred patients undergoing PCI were randomized to manual compression, Perclose Proglide? or Angio‐Seal VIP?. Ambulation was allowed 3 hr after Perclose Proglide? or Angio‐Seal VIP? and 6 hr after compression. Results: There were 10 failures to deploy Perclose Proglide? and none for Angio‐Seal? (P < 0.01). Time to hemostasis was significantly shorter with Angio‐Seal VIP? compared with Perclose Proglide? (5.3 vs. 46.8 min, P < 0.01). Time to ambulation was shorter with Angio‐Seal VIP? than with Perclose Proglide? (261 vs. 334 min, P < 0.05) and the time to ambulation, as expected, was longest with compression (943 min, P < 0.01 vs. Angio‐Seal VIP? and Perclose Proglide?). Delay in ambulation was higher with Perclose Proglide? than with Angio‐Seal VIP? (18 vs. 9, P < 0.01). There was no significant difference in major vascular complications between groups. Compared with compression, patient discomfort was significantly improved with Angio‐Seal? (1.5 vs. 2.0, P < 0.01), but not with Perclose Proglide?. Conclusion: The Angio‐Seal VIP? device has a high rate of deployment success, which is significantly better than that of Perclose Proglide?. Angio‐Seal VIP? allows for earlier hemostasis and ambulation compared with both compression and Perclose Proglide? and is associated with greater patient satisfaction compared with compression. © 2008 Wiley‐Liss, Inc.     

Use of Angio-Seal closure device when the arteriotomy is above or below the common femoral artery

Background:

The majority of vascular complications during diagnostic coronary angiography occur while accessing the femoral artery. Angio‐Seal vascular closure devices are indicated for closure of arteriotomies of the femoral artery, but not when the puncture site is above or below the femoral artery.

Hypothesis:

Under certain circumstances, use of the Angio‐Seal closure device above or below the common femoral artery may be safe and effective.

Methods:

Consecutive patients at a single high‐volume medical center having documented high or low arteriotomies were closed using an Angio‐Seal closure device. Patients were chosen when they received a single arterial puncture, the arteriotomy was away from branch vessels, and the diameter of the artery at the site of sheath entry was of large enough caliber to suggest placement would be successful. Patients were then followed longitudinally for complications.

Results:

Sixty‐two patients had non–femoral artery sheath placement. Twenty‐two patients had “high” puncture sites, and 40 patients had “low” puncture sites. All were successfully closed using the Angio‐Seal vascular closure device and had no complications.

Conclusions:

Although not approved for placement in areas above or below the femoral artery, off‐label use of the Angio‐Seal arteriotomy closure may be safely performed when patient characteristics are favorable. © 2011 Wiley Periodicals, Inc. The authors have no funding, financial relationships, or conflicts of interest to disclose. Neither author has a conflict of interest with St. Jude Medical or with the Angio‐Seal device.     

A comparative evaluation of arterial blood flow and the healing response after femoral artery closure using angio-seal STS Plus and StarClose in a porcine model

Objectives: This study prospectively evaluated the acute and chronic arterial blood flow and vascular pathology after vessel closure using two commonly used closure devices controlled by deploying both devices in each animal. Background: Several vessel closure systems are approved for clinical use; however, few direct comparisons have ever been performed and no randomized case controlled study has been published using FDA‐approved devices. Methods: Ninteen Sous Scroufulae pigs underwent bilateral percutaneous arteriotomies using ultrasound‐guided 6 Fr sheath insertion in both common femoral arteries. The femoral access site was then closed using either an Angio‐Seal STS Plus?, an absorbable collagen sponge, or StarClose?, a self‐closing nitinol clip. Angiograms and ultrasound of the site were performed prior to closure and immediately afterwards. At follow‐up, ultrasound was performed at the site and the specimens were sent for histopathology. Results: Baseline femoral artery diameters (centimeters) were similar in both groups by U/S (5.2 ± 0.3, 5.3 ± 0.3) and quantitative angiography (4.6 ± 0.7, 4.6 ± 0.8) . Postdeployment angiograms showed a vessel diameter stenosis of 65%± 24% with Angio‐Seal (n = 18) and 50%± 22% with StarClose (n = 18), P = 0.04. 2D U/S performed immediately postdeployment showed vessel diameter stenosis of 59%± 33.0 with Angio‐Seal (n = 19), and 35%± 20 with StarClose (n = 19), P = 0.01. At 7‐, 30‐, and 60‐day follow‐up, no appreciable differences in the vessel diameter were observed by U/S. At early follow‐up (7 and 30 days), Angio‐Seal arteriotomy closure sites were associated with higher inflammatory and hemorrhage scores, but no difference was seen at late (60‐day) follow‐up. Conclusions: The StarClose closure device is associated with less short‐term vessel injury compared to Angio‐Seal STS Plus; however, this difference was not statistically significant after 60 days.     

Use of a low‐profile,compliant balloon for percutaneous aortic valvuloplasty

Objectives : To determine the safety and immediate efficacy after balloon aortic valvuloplasty (BAV) with a new, low‐profile balloon. Background : BAV has a continuing role in the management of high‐risk patients with severe aortic stenosis (AS). BAV with traditional noncompliant balloons requires a large femoral arteriotomy and is associated with high rates of access site complications. Methods : We retrospectively reviewed medical records of 20 consecutive patients undergoing BAV for severe AS. Retrograde transfemoral BAV was performed with a low‐profile, compliant valvuloplasty balloon. Before and after BAV, transaortic gradients were measured invasively and by echocardiography, and aortic valve area (AVA) calculated. Access site complications, functional class and survival were recorded. Results : Patients were 79 ± 12 years old and had an estimated mortality from open aortic valve replacement of (12.5 ± 9.6)%. By catheterization, mean aortic gradient fell from 44 ± 15 to 29 ± 10 mm Hg (P < 0.001) and AVA increased from 0.63 ± 0.22 to 0.89 ± 0.33 cm² (P < 0.001). New York Heart Association functional class improved from 3.5 ± 0.7 to 2.7 ± 0.8. Procedural mortality was 0%. There were no vascular complications or significant worsening of aortic regurgitation. Conclusion : Transfemoral BAV using a low‐profile compliant balloon is feasible with acceptable immediate results and safety. © 2009 Wiley‐Liss, Inc.     

Percutaneous balloon aortic valvuloplasty: antegrade transseptal vs. conventional retrograde transarterial approach.

Percutaneous balloon aortic valvuloplasty (BAV) has been limited predominantly to a palliative treatment for poor surgical candidates with critical aortic stenosis and multiple high-risk or comorbid conditions. The most commonly used technique for BAV is the retrograde approach, in which the balloon is passed via the femoral artery using 12-14 Fr sheaths. We compared an antegrade transseptal approach using the Inoue balloon vs. the retrograde transarterial approach using conventional balloons. The antegrade group had an improved acute hemodynamic outcome, including 20% additional increase of aortic valve area and 20% greater reduction of transaortic valve gradient compared to the retrograde approach. Preclosure with the Perclose device was used for the 14 Fr venous access sites, resulting in immediate hemostasis, minimizing the need for transfusion, and diminishing the period of bed rest. The improved acute efficacy and relative ease of venous access for the antegrade approach facilitate BAV by eliminating the need for large-caliber arterial access sheaths. The antegrade approach also incorporates technical elements necessary for percutaneous aortic valve replacement and may have expanded applications as an adjunct to this developing therapy. The impact of improved acute results on the long-term clinical outcome for this patient group will require further study.     

Total percutaneous endovascular repair of abdominal aortic aneurysms using Perclose ProGlide closure devices.

PURPOSE: To describe a technique for access site closure in percutaneous abdominal aortic aneurysm (AAA) repair using double Perclose ProGlide devices to overcome the problems associated with the bulky delivery system and braided suture of the antecedent (Prostar) device. TECHNIQUE: After obtaining guidewire access, 2 Perclose ProGlide sutures are deployed at 90 degrees to each other. The appropriate sheaths are placed over the stiff guidewires. After the stent-graft procedure is completed, an assistant holds pressure while the knots are tightened with the stiff guidewire still in the artery. Once the second knot is tightened with the knot pusher and after confirming adequate hemostasis, the wire is removed, pressure is applied, and heparin reversed. This method has been used in 17 consecutive patients (age range 65-85 years) undergoing endovascular AAA repair. One patient needed patch angioplasty and 2 required small incisions for additional suture placements (81% primary success rate for total percutaneous repair, 90% success rate for all sites). CONCLUSION: We have found the double Perclose ProGlide technique to be easy to use, safe, and feasible for total percutaneous AAA repair. More experience with longer follow-up is needed to assess its potential to replace the Perclose Prostar closure device for total percutaneous AAA repairs.     

Percutaneous suture closure for management of large French size arterial puncture in aortic valvuloplasty

Percutaneous aortic valvuloplasty produces acute hemodynamic and clinical improvement in patients with aortic stenosis who are poor candidates for surgical valve replacement. The benefits of this procedure are mitigated by the high restenosis rates and 1--2 year mortality, in addition to significant vascular complications associated with the large arterial puncture necessary for retrograde arterial approaches. We describe the use of suture closure techniques to reduce the vascular morbidity associated with this procedure. We reviewed 31 consecutive patients who underwent percutaneous aortic valvuloplasty and suture closure with the Perclose device between April 1998 and September 2000. After diagnostic catheterization using 6--8 French (Fr) sheaths, an 8 or 10 Fr Perclose device was preloaded into the artery and the untied sutures left in place. A 12.5 or 14 Fr sheath was passed over the wire, through the sutures. The sutures were tied at the conclusion of the procedure, in conjunction with sheath removal. Twenty-seven out of 31 patients (87%) had successful suture closure of the arteriotomy and did not require prolonged bed rest, manual compression or a compression device. There were 4 failures of percutaneous suture closure, requiring conventional manual compression and bed rest for hemostasis. No patient required surgical repair of the arteriotomy, nor were there any limb complications. Compared to 39 consecutive prior patients who had their arterial puncture managed with manual compression, length of stay was shorter (2.2 days versus 5.3 days) and fewer patients received blood transfusions (0% versus 29%). Preloaded suture closure of the arterial puncture is a useful technique for achieving hemostasis after removal of the large sheaths used for percutaneous valvuloplasty, and reduces the post-procedure patient discomfort and prolonged bed rest associated with this procedure.     

Congenital aortic stenosis: A novel technique for ventricular pacing during valvuloplasty

Objectives : The main objective of this study is to describe a new technique for rapid ventricular pacing to maintain balloon stability during balloon aortic valvuloplasty (BAV) without using transvenous temporary pacemaker electrode. Background : The safety and efficacy of rapid right ventricular pacing to facilitate balloon stability during BAV has been previously reported. However, it necessitates an additional femoral venous access, an additional sheath, and a temporary pacemaker electrode. Methods : This was a prospective pilot study. Rapid ventricular pacing was performed through back‐up guidewires inserted into the left ventricle for balloon advancement and by an adhesive patch placed on the back of the patient. The technique was performed during BAV procedure in all of 15 consecutive children diagnosed as congenital aortic stenosis. Pacing was performed at a rate decreasing systolic aortic pressure to the point of 40–50% of baseline. Results : The technique was successful in all patients. Effective capture, stable pacing, and balloon stability were achieved in all children using very low outputs. No sustained arrhythmias or other procedure‐related complications occurred. Mean aortic valve gradient decreased from 68.5 ± 20.4 mm Hg to 20.4 ± 10.2 mm Hg. Degree of aortic regurgitation progressed from grade 0 to 1 in three patients and remained unchanged in 12 patients. Conclusions : This study demonstrated that back‐up guidewires can be used effectively and safely for pacing during BAV procedures. This technique omits probable complications related to a second vascular access and may shorten the procedure time and decreases costs by eliminating the use of an additional sheath and a temporary pacemaker electrode. © 2008 Wiley‐Liss, Inc.     

Temporary aortic occlusion to facilitate large-bore arterial closure

Percutaneous closure of large-bore arterial sheaths remains a clinical challenge. We report a case of facilitated large-bore closure using a low-profile valvuloplasty balloon for aortic occlusion. This technique enhanced percutaneous closure device deployment and improved hemostasis during arteriotomy closure.     

Closure of the femoral artery after cardiac catheterization: A comparison of Angio‐Seal,StarClose, and manual compression

Objectives : To compare Angio‐Seal (AS) and StarClose (SC) and manual compression (MC) on efficacy of hemostasis, complication rate, safety of early mobilization, and patient comfort. Background : Closure of the femoral artery after cardiac catheterization can be obtained through different methods. Today, physicians can choose from a number of different devices to achieve arterial closure. Methods : In a prospective trial 450 patients were randomized to AS, SC, or MC. Patients were mobilized 1 to 2 hr after device placement, and 6 hr after MC. Data were collected during hospital admission and by telephone at one month after hospital discharge. Results : Devices were used in 138/150 allocated to AS and 124/150 allocated to SC patients (92% vs. 83%, P = 0.015) Patients with MC experienced more pain during sheath removal than patients receiving a device, and rated their period of bed rest as less comfortable. Oozing and need for pressure bandage at the puncture site were observed in 37 AS patients and 57 SC patients (25% vs. 38%, P = 0.002). Hematoma occurred in 15 AS patients, in 17 SC patients, and in 14 MC patients (11 vs. 14 vs. 9%, ns). Conclusion : There is no difference in safety between the three methods of arterial closure. SC was more often not used or successfully deployed. SC patients more often had continuing oozing. On patient comfort, closure devices performed better than MC. Early ambulation in patients with a closure device is safe. AS is the preferred method of arterial closure after cardiac catheterization. © 2008 Wiley‐Liss, Inc.     

A Novel Technique for 14 French Arteriotomy Closure after Percutaneous Aortic Valvuloplasty Using Two Mynx Closure Devices

Management of large bore arterial access sites often represents a challenge during interventional procedures, and usually requires prolonged manual compression, though suture-mediated closure techniques have been described. We report our experience in using the Mynx vascular closure device to close a 14 French femoral arteriotomy in two patients undergoing percutaneous balloon aortic valvuloplasty.     

Paravalvular leak closure for persisting aortic regurgitation after implantation of the corevalve transcatheter valve

Significant aortic regurgitation after TAVI results in lack of symptomatic and prognostic benefit from the procedure and generally requires intervention. While most of the regurgitations can be successfully targeted with standard techniques, occasional patients have restrictive calcification resistant to post‐dilatation and significant regurgitation persists. We present a case of refractory aortic regurgitation successfully treated with percutaneous paravalvular leak closure. An 81‐year‐old man with symptomatic severe aortic stenosis underwent a transfemoral CoreValve TAVI in December 2009. He had significant aortic regurgitation refractory to medical and interventional therapy including balloon post‐dilatation, valve repositioning and valve‐in‐valve reimplantation. Aortic regurgitation remained severe and therefore in early 2013, we proceeded with an attempted percutaneous closure of the residual paraprosthetic leak. Using 6‐French femoral access and a Terumo wire, the defect was successfully crossed with a 4‐French Multipurpose catheter and an 8 mm Amplatzer Vascular Plug 4 device (St. Jude Medical) was deployed through this catheter, resulting in abolition of aortic regurgitation on aortography and TOE, with associated excellent clinical response. Refractory paravalvular aortic regurgitation post CoreValve implantation can be successfully treated using the Amplatzer Vascular Plug 4 device. © 2013 Wiley Periodicals, Inc.     

Percutaneous transapical pseudoaneurysm closure following transcatheter aortic valve replacement

Left ventricular pseudoaneurysm (LVP) formation is a rare but potentially life‐threatening complication of transapical transcatheter aortic valve replacement (TAVR). Conventionally, a pseudoaneurysm has been treated surgically; however, improved transcatheter technique and device technology have made a percutaneous closure of LVP an increasingly viable option, especially in a patient unfavorable for surgery. A TAVR candidate is most likely at increased surgical‐risk or inoperable. Therefore a percutaneous closure can be a reasonable strategy for LVP, but its experience following this emerging aortic valve procedure remains limited. We describe a case of LVP formation after TAVR in which it was efficiently treated with a percutaneous closure using a transapical approach via LVP. The first attempt was performed with a transfemoral approach. Pre‐closure angiography revealed an eccentric shape of a LVP neck like a “chicken leg”. This shape caused serious difficulty to cross LVP with a wire and it was not accomplished. However, the LVP location was at the apex and we could access from a chest wall through the pseudoaneurysm in the second attempt. This approach allowed a close and coaxial wire manipulation and the neck of LVP was finally crossed. After that, a closure device was deployed and the second procedure was successfully completed. An approach selection often contributes to a procedural success. This is the first case of a percutaneous LVP closure following TAVR using a transapical access and may suggest this approach as a possible option for this catheter closure in TAVR candidates. © 2016 Wiley Periodicals, Inc.     

First human experience of thermal arterial closure

Objectives: This study was designed to evaluate the efficacy and safety of the CardioDex arterial closure device, which is a novel femoral artery closure device used following percutaneous cardiac catheterization. Background: Current devices utilized to achieve hemostasis of the femoral artery following percutaneous cardiac catheterization include collagen plug and suture mediated devices, but are associated with significant vascular complications. The CardioDex closure device utilizes thermal energy to cause collagen shrinking and swelling and thereby, achieve hemostasis. Methods: The device was evaluated in a prospective nonrandomized single‐center trial with patients undergoing 6F invasive cardiac procedures. Femoral artery puncture closure was performed immediately at completion of the procedure, followed by 3–4 minutes of manual compression. Time to hemostasis (TTH), time to ambulation (TTA), and short‐term clinical follow‐up data were collected. Results: A total of 34 patients including 21 diagnostic and 13 interventional cases were evaluated. The median TTH was 3 min in diagnostic and 4 min in interventional cases. TTH was independent of activated clotting time (ACT). The median TTA was 2.75 hr and 3.37 hr in diagnostic and interventional groups, respectively. There were no major adverse events identified at 1 week and 30 day follow up. Conclusions: This first in human clinical experience with the CardioDex closure device demonstrates that in the small cohort studied, it is safe and effective in diagnostic cardiac catheterization and also in interventional cases on mild anticoagulation (mean ACT = 188 sec). It has the advantage of leaving no foreign material in the body following use. © 2013 Wiley Periodicals, Inc.     

Intracoronary autologous bone marrow cell transplantation beneficially modulates heart rate variability

Antegrade femoral artery access is commonly used for percutaneous transluminal revascularization of ipsilateral lower limbs in patients with critical limb ischemia. While hemostasis at the end of the procedure can be achieved by manual compression, this may lead to an increase in local vascular complications. Femoral artery closure devices, such as the Angioseal collagen plug and anchor device, have been approved and shown of benefit after retrograde femoral artery catheterization. To date, there are however no data on the use of such arteriotomy closure device after antegrade femoral access. We hereby report a case series of five patients in whom Angioseal was successfully used after antegrade femoral puncture and below-the-knee percutaneous transluminal angioplasty. In all cases the device enabled immediate and complete hemostasis without major complications, despite the intense antithrombotic regimen, including heparin, aspirin, and clopidogrel in all patients, as well as glycoprotein IIb/IIIa inhibitors (in two patients) and fibrinolytic therapy (in one).