Percutaneous transcatheter occlusion of the patent arterial duct using the pfm DuctOcclud Coil via a trans-aortic and trans-pulmonary approach

Occlusion using coils is now the treatment of choice for closure of the patent arterial duct. The DuctOcclud (pfm AG, Cologne, Germany) device is a relatively new retrievable coil for such trans-catheter closure. This study expands on previously reported experience with this device, summarizes the advantages of the device, and compares trans-pulmonary and trans-aortic delivery in 47 patients. There were 27 females. The mean, and median, ages were 4.6, and 2.85 years, respectively. The youngest patient was aged 9 months, weighing 7 kg. A trans-aortic delivery was used in 41 cases, and a trans-pulmonary approach in 6 cases. Of the 47 procedures, 45 (96%) were successful at the first attempt. The other two patients were treated successfully at the second attempt, giving a 100% rate of success. The technical characteristics of the coil allowed for its repeated maneuvering until an optimal position was obtained prior to release. Closure was confirmed by lack of ductal flow by echo-doppler on follow- up echocardiography. No short- or long-term complications of the procedure were noted in any of the patients. We conclude that the DuctOcclud device is an effective and safe method for closure of the small-to-moderately patent arterial duct. In a large proportion of patients, trans-aortic delivery is the preferred approach.     

Initial experience with a new compression device for hemostasis after femoral arterial puncture.

We evaluated a new hemostasis device to maintain focused pressure over the femoral artery puncture site for 2-6 hours in 330 cases after diagnostic catheterization or coronary angioplasty. No patient developed later hematoma or vascular complications. The initial favorable experience suggests that this hemostasis device has advantageous features of stability and site visualization and is a suitable adjunct to current methods of maintaining puncture site pressure after brief manual compression following arterial catheterization.     

Use of intracardiac echocardiography to guide implantation of a left atrial appendage occlusion device (PLAATO).

BACKGROUND: Over 90% of thrombi in atrial fibrillation (AF) originate from the left atrial appendage (LAA). Patients with contraindications to anticoagulation are potential candidates for LAA occlusion using the Percutaneous Left Atrial Appendage Transcatheter Occlusion system (PLAATO, ev3 Inc., Plymouth, MN). Transesophageal echocardiography (TEE) is typically used to guide implantation. OBJECTIVE: This study sought to examine the utility of intracardiac echocardiography (ICE) in providing adequate imaging guidance as an alternative to TEE during PLAATO implantation. METHODS: The study group consisted of 10 patients who underwent PLAATO implantation with simultaneous TEE and ICE imaging guidance. ICE was used to perform the following tasks typically fulfilled by TEE: (1) verification of the absence of LAA thrombus, (2) identification of the LAA ostial dimension for device sizing, (3) guidance of transseptal puncture, (4) verification of the delivery sheath position, and (5) confirmation of location and stability of device before its irrecoverable release. The ability of ICE to perform these tasks was assessed from three separate positions: the standard right atrial (RA) position, within the coronary sinus (CS), and the right ventricular outflow tract. RESULTS: ICE imaging of the LAA was optimal from within the CS, although imaging from the proximal pulmonary artery provided better visualization of the distal LAA in cross-section. The LAA dimensions, confirmation of the absence of LAA thrombus, proper positioning of the delivery sheath, verification of location and stability of the device obtained by ICE were consistent with findings from TEE. CONCLUSION: Using nonconventional imaging planes, ICE imaging was able to perform the intraprocedural functions provided by TEE during implantation of the PLAATO left atrial appendage occlusion device.     

Percutaneous femoral arteriotomy repair -- initial experience with a novel staple closure device

The Vascular Closure System (EVS ) is the first device to utilize a staple mechanism to close percutaneous femoral arteriotomies following catheter-based procedures. To assess safety and efficacy, the EVS was used to close 89 consecutive femoral arteriotomies. Closure success was defined as complete cessation of bleeding within five minutes of staple delivery. The overall closure success rate was 92.1% (n = 82). Mean time to complete hemostasis was 2.47 1.42 minutes. No complication (re-bleeding, pseudoaneurysm, transfusion, arteriovenous fistula, infection or decrease in distal pulses) occurred at 24-hour and 7-day follow-up. We conclude that staple-based technology provides a safe and useful method for mechanical closure of percutaneous femoral arteriotomies.     

Immediate arterial hemostasis after cardiac catheterization: Initial experience with a new puncture closure device

A novel device for obtaining arterial hemostasis after invasive procedures was tested in 30 patients undergoing diagnostic catheterization (26 patients) or coronary angioplasty (4 patients). The device is deployed through an arterial sheath and forms a positive mechanical seal both inside and outside the defect in the arterial wall. The components are all bioabsorbable. Thirteen patients received a heparin bolus during the catheterization procedure. The activated clotting time recorded in 15 patients just prior to device deployment averaged 264 sec. 29 of 32 attempted device deployments were successful (91%); and the remaining 3 devices pulled completely out as called for by design in the event of incomplete deployment. Twenty-nine patients ultimately achieved successful hemostasis using the device, with the other patient receiving manual hemostasis. Of these 29, hemostasis was immediate and complete in 19 patients. Light digital pressure was required in another 8 patients for less than 5 min. There was minor delayed bleeding requiring supplemental light pressure in several cases. A total of 11 patients required supplemental pressure in addition to the hemostasis device. The use of bolus heparin was significantly (P = 0.05, Fisher's exact test) related to the requirement for supplemental pressure. Three patients developed hematomas, one of which was present prior to device deployment. The other two patients had received bolus heparin. No patient required transfusion or surgical repair. There was no change in the ankle/brachial systolic blood pressure index after device deployment or at late (30–60 day) follow-up. Ultrasound studies revealed no significant pathology relative to the device. There was no residual evidence of the device at 2 month follow-up ultrasound study. Thus the Kensey Nash Hemostatic Puncture Closure Device can safely, reliably, and rapidly provide arterial hemostasis after cardiac catheterization procedures. Its use warrants further study in comparison to standard manual hemostasis.     

Femoral artery occlusion after using a suture‐mediated arterial puncture closure device

A femoral artery occlusion is a very rare complication after using a suture‐mediated arterial puncture closing device (APCD). The mechanism of the femoral artery occlusion is unclear and its standard management has not been established. This case describes a mechanism of femoral artery occlusion by a suture‐mediated APCD and suggests a method of prevention and treatment. © 2008 Wiley‐Liss, Inc.     

Initial experience with the novel patent foramen ovale occlusion device Nit‐Occlud® in patients with stroke or transient ischemic attack

• Percutaneous approach rather than surgical cutdown is the procedure of choice for TAVR patients to minimize morbidity and procedure time.
• ProGlide has been shown to have noninferior outcomes versus surgical cutdown with shorter procedure time and less pain; noninferiority was not demonstrated by single Prostar XL in a randomized trial of “preclosure” for endovascular aortic aneurysm repair. The current study did not include a ProGlide arm.
• As the size of Transcatheter Aortic Valve Replacement devices continues to decrease, the need for large bulky 4‐needle devices like the Prostar XL is likely to become obsolete.

     

Transcatheter occlusion of the arterial duct with Cook detachable coils: early experience.

OBJECTIVE: To assess the effectiveness of modified, controlled release Gianturco coils for transcatheter occlusion of the arterial duct. DESIGN: Prospective study, approved by local medical ethics committee. SETTING: Tertiary paediatric cardiac centre. PATIENTS: 43 patients with left to right shunting through the arterial duct, two of whom had a residual leak after surgical ligation and three had residual shunting after previous Rashkind umbrella implantation. INTERVENTION: Transcatheter delivery of one or more coils to the arterial duct. MAIN OUTCOME MEASURES: Complete occlusion of the arterial duct, based on intention to treat and judged by Doppler echocardiography. Absence of flow disturbance in the branch pulmonary arteries and the descending aorta following the procedure. Assessment of cost of the disposable items used. RESULTS: At a median follow up period of three months complete duct occlusion was achieved in 37 (86%) of the 43 patients. No flow disturbance in the branch pulmonary arteries or the descending aorta was detected in any patient. The median cost of disposable items used during the procedure was 342 pounds. CONCLUSIONS: The Cook detachable coil is an effective and financially attractive alternative to the Rashkind umbrella for closure of the arterial duct.     

Transcatheter occlusion of a classical BT shunt with the Amplatzer Duct Occluder II

We report on a 57‐year‐old woman who underwent transcatheter occlusion of a residual classical Blalock‐Taussig shunt with the Amplatzer® Duct Occluder II (ADO II) 35 years following definitive surgical correction for tetralogy of Fallot. © 2008 Wiley‐Liss, Inc.     

Hypoxemia after prior cardiac surgery due to interatrial shunting and its treatment with a novel transcatheter occlusion device

We describe two unusual cases of hypoxemia after cardiac surgery due to intracardiac right-to-left shunting through a patent foramen ovale or atrial septal defect. The interatrial defects were successfully occluded by placement of a novel, transcather device, the Angelwings Atrial Septal Defect Occluder Device, with resolution of hypoxemia. Cathet. Cardiovasc. Intervent. 46:452–456, 1999. © 1999 Wiley-Liss, Inc.     

Multicenter clinical experience with the development of a novel short coronary stent and its prototype device

Our initial experience with the Micro Stent PL™ and its prototype intracoronary stent is described. A total of 206 stents were implanted in 84 patients for threatened closure or restenosis following balloon angioplasty. The stenting procedure was successful and uncomplicated in 83 of 84 patients. Potential advantages of this particular stent relate to its short length, low surface area, expandability over a range of diameters, radiopacity, low profile, and ease of delivery. © 1996 Wiley-Liss, Inc.     

Totally implantable arterial device (TIAD): a questionable complication

The authors report a complication of a totally implantable arterial device in a patient in which the device was inserted to prevent recurrence of hepatic metastasis. After intrahepatic chemotherapy, during the nursing of the totally implantable arterial device, the patient developed a mass close to the duodenal loop that disappeared seven months later. The spontaneous decrease of this mass suggests the hypothesis of a hematoma due to a rupture of a pseudoaneurysm of a small collateral artery.     

Femoral artery infection associated with a percutaneous arterial suture device

This is a case report of a femoral artery infection with fatal outcome after using a percutaneous suture mediated closure device: A 77-year old patient underwent diagnostic angiography of his thoracic and abdominal aortic aneurysm, the puncture site was closed with the Perclose system. He developed a staphylococcal femoral artery infection with groin abscess, requiring surgical intervention with debridement and removal of the Perclose suture. After stent graft exclusion of the thoracic and abdominal aortic aneurysm a staphylococcal sepsis occurred and the patient died of aneurysm rupture months later despite long term antibiotic therapy. Since the use of the Perclose device carries an increased risk of femoral artery infection with septic endarteritis and bacteremia, it should not be used in routine diagnostic angiography.     

Evaluation of a novel endoluminal vascular occlusion device in a porcine model: early and late follow-up.

PURPOSE: To evaluate the efficacy of a new vascular occlusion device (VOD) in a preclinical controlled study versus embolization coils. METHODS: The Biomerix VOD was made from a biodurable porous polyurethane matrix in the shape of a cylinder measuring 1.5 cm long by 6.0 mm wide. Thirty-three swine were selected to undergo embolization of a 3 to 5-mm-diameter iliac artery using either a single VOD (27 animals) or sufficient Cook fibered stainless steel coils to achieve angiographic occlusion (6 controls). Test animals were assigned to undergo angiography at 1 week (n=11), 1 month (n=6), 3 months (n=6), or 6 months (n=4). Two control animals were assigned to angiographic follow-up at 1 week, 1 month, and 3 months. Test and control animals were euthanized at each time point to explant occluded vessels for histological analysis. Study endpoints were device utilization, time to occlusion, postdeployment migration, and persistent angiographic occlusion at 7, 30, 90, and 180 days. RESULTS: One VOD was deployed in each test animal, whereas a mean 3.3+/-0.8 coils were needed to achieve angiographic occlusion in the 6 controls (p<0.001). The time to occlusion was significantly shorter with the VOD (1.46+/-0.73 versus 5.83+/-1.60 minutes for the coils; p<0.001). There was no evidence of recanalization or filling defects at the site of VOD deployment, while filling defects were seen in 3 of 6 coil-treated controls. The VOD arm showed superior angiographic occlusion versus coils at the 1-week, 1-month, and 3-month angiographic follow-up time points. Histological evaluation showed that the VOD was equivalent to the embolization coils at the 1-week (n=6) and 1-month (n=6) endpoint (100% luminal occlusion). In the 3-month group (n=6), the VOD showed 95% to 100% luminal occlusion versus 90% to 95% in the control animals. In the 6-month group, VOD showed 85% to 95% occlusion. CONCLUSIONS: The Biomerix VOD appears highly effective and reliable, resulting in significantly faster and longer lasting occlusion compared with fibered stainless steel embolization coils.     

Total occlusion of the left main coronary artery: The Coronary Artery Surgery Study (CASS) experience

Total occlusion of the left main coronary artery was confirmed on review of the coronary angiograms in 12 (0.06 percent) of the 20,197 patients entered into the Coronary Artery Surgery Study (CASS) before coronary arterial surgery. Clinical features alone could not distinguish the patients with total occlusion of the left main coronary artery from those enrolled in the CASS with subtotal stenosis of this vessel. The right coronary artery had a stenosis greater than or equal to 70 percent of luminal diameter in 7 of the 12 patients. Collateral flow to the left coronary artery was defined as “substantial” or “limited” based on the presence or absence of clear visualization of the main channel of either the left anterior descending or left circumflex coronary artery during coronary angiography. Of the eight patients with “substantial” collateral flow, one (13 percent) had an aneurysmal or dyskinetic left ventricular wall segment, whereas all (100 percent) of the three patients with “limited” collateral flow had dyskinesia or an aneurysm (p < 0.05). Seven patients underwent coronary bypass graft surgery; 6 (86 percent) of these patients were living at their most recent follow-up, a mean of 46 months after entry into the CASS. Two of these patients continued to have angina pectoris. Five patients did not undergo coronary bypass grafting and 2 (40 percent) were still alive at their most recent follow-up, a mean of 45 months after entry into the CASS. One of these patients had angina pectoris. The difference in survival between the medical and surgical groups was not statistically significant.

This study indicates that patients with total occlusion of the left main coronary artery are uncommon and cannot be distinguished by presenting features alone from patients having subtotal stenosis of the left main coronary artery. “Substantial” coronary collateral blood flow is associated with better left ventricular wall motion than is “limited” collateral flow. Prolonged survival and lessening of symptoms may occur after coronary bypass grafting although long-term survival is possible without it.     

First experience with the use of a clip device for closure of arterial approach after endovascular treatment of coronary arteries

Aim of the present study was assessment of the StarClose Vascular Closure System - novel device for mechanical closure of femoral artery puncture site. We included in this study 29 patients in whom after procedure of endovascular treatment puncture site was closed with the given device. Control group comprised 34 patients in whom hemostasis was conducted by way of manual compression of puncture site according to standard technique. Femoral artery was clipped immediately after completion of the stenting procedure irrespective of the last result of activated partial thromboplastin time measurement. Success of the use of the StarClose was 100%. Activation of a patient was undertaken substantially earlier compared with the group of manual hemostasis. Sitting up in bed was performed in 2 hours after completion of hemostasis procedure compared with 16 hours in control group, walking within ward was started in 3.5 hours compared with 17 hours in control group ( < 0.0001 in both cases). Duration of the procedure of hemostasis was substantially smoller in the group of closing device compared with the group of manual hemostasis (1.7 and 23 min, respectively). With this no complications from the site of puncture were observed in the group of closing device. In the group of manual hemostasis one patient (2.9%) had hematoma nor requiring special treatment and in one more patient (2.9%) after violation of bed regimen minor bleeding occurred from puncture site (was eliminated by additional manual compression for 20 min). Total number of complications in the group of manual compression was 5.8%. Thus compared with traditional manual hemostasis. The use of StarClose clip device allows to activate patients after endovascular treatment substantially earlier.