Final results of the protected superficial femoral artery trial using the FilterWire EZ system.

The purpose of this study was to evaluate the safety and efficacy of debris-capture for distal protection using the FilterWire EZ Embolic Protection System (Boston Scientific, Mountain View, CA) with the additional aim to further define the incidence of distal embolization during superficial femoral artery (SFA) interventions. A prospective, single-centre registry was designed to evaluate the performance of the FilterWire EZ in capturing debris during standard SFA percutaneous intervention. The PRO-RATA study included 30 patients suitable for PTA (Fontaine IIb to III or Rutherford I to II classification). The primary end points were occurrence of distal embolization or decreased runoff, improvement in ankle-brachial index ankle-brachial index (ABI) after the procedure, and number of filters containing emboli. Secondary end points included major adverse events (i.e., procedure- or device-related death and/or clinical target lesion revascularisation), device delivery, deployment success, and incidence of embolic recovery (patients with device success exhibiting embolic protection in the filter). Procedural success was determined as ≤30% residual stenosis with no worsening of distal runoff as determined on angiography. A total of 29 patients (age 66.2 ± 12 years; total no. of limbs = 30; total no. of lesions = 30) suitable for PTA were enrolled in the study between February 2007 and March 2008. There were 26 patients with claudication (Fontaine IIB) and 3 patients with stage IV peripheral vascular disease. In one patient, lesions in both legs were treated. No procedural or device-related complications occurred. The average degree of stenosis was 86 ± 7%. Stenosis length ranged from 8 to 88 mm. The average degree of residual stenosis was 10 ± 10%. ABI improved from 0.56 ± 0.16 to 0.92 ± 0.19 (P < 0.05). No restenosis or dissection was seen at 1-month ultrasound follow-up. Macroscopic debris was found in 27 of 30 filters of all distal protection devices used in all 29 patients. Debris particle size ranged from 90 to 2000 µm (1200 ± 640). Histological debris analysis showed platelets, erythrocytes, inflammatory cells, extracellular matrix, and cholesterol as being the major components of emboli. Additional immunochemistry showed no correlation between lesion morphology and debris components. The FilterWire EZ is easy and safe to handle. The system caused no complications. In all cases, macroscopic debris was captured. Using a distal protection device during femoropopliteal interventions has the potential to prevent migration of debris, which may be important for high-risk patients with limited distal runoff.

Mitral valved stent implantation.

OBJECTIVE: To date, transfemoral and trans-apical valved stent implantation techniques are limited to the replacement of pulmonary and aortic valves in a strictly selected group of patients. The current study was designed to assess the short-term follow-up using a mitral valved stent in off-pump technique. METHODS: A self-expanding, repositionable mitral valved stent was created for trans-apical implantation. Five pigs underwent successful trans-catheter implantation. Data were gathered to assess the animals' haemodynamical stability after stent implantation (n=5), 6h (n=5) and 1 week (n=4). The valved stent function was assessed by trans-oesophageal echocardiography and ventriculogram. Cardiac computed tomography (CT) was used to evaluate positioning of the new implant. RESULTS: Precise valved stent deployment and accurate subsequent adjustment of its intra-annular position allowed for reduction of paravalvular leakage in all animals. The deployment time ranged from 122 to 271 s and blood loss from 65 to 245 cc. Accurate positioning was established in all but one animal. The average mean transvalvular gradient and mean gradient across left ventricular outflow tract (LVOT) recorded immediately after deployment, 6 h and 1 week were 1.9 + or - 0.9 mmHg, 3.5 + or - 1.6 mmHg, 4.1 + or - 02.3 mmHg and 1.4 + or - 01.3 mmHg, 1.5 + or - 0.7 mmHg 1.9 + or - 0.7 mmHg, respectively. Mild regurgitation was present after valved stent deployment in one out of five animals after 1h, one out of five animals at 6h, and two out of four animals at 1 week. All animals exhibited normal haemodynamics after mitral valved stent implantation and maintained stability for the period of monitoring (6h). One animal died of unrecognised imperfect valved stent positioning after 1 day. In the subsequent animals, valved stent migration, embolisation, systolic anterior movement or LVOT obstruction was not observed after 1 week follow-up. CONCLUSIONS: The new mitral valved stent can be deployed in a reproducible manner to achieve reliable stent stability, minimal gradients across the LVOT and adequate valved stent function in short-term follow-up.

Percutaneous intraluminal recanalization of long, chronic superficial femoral and popliteal occlusions using the Frontrunner XP CTO device: a single-center experience.

The purpose of this study was to examine the safety and efficacy of the Frontrunner XP CTO (chronic total occlusion) Catheter (Cordis) for recanalization of long femoropopliteal artery occlusions. A Frontrunner catheter was used to treat 26 CTOs in SFA after guidewire failure (68.3 +/- 8.8 years). Sixty-seven percent of patients had severe claudication. Critical lower limb ischemia with rest pain or minor tissue loss was present in three and eight patients, respectively. All the lesions were considered complex (TASC B, C, and D); 68% of the lesions were heavily calcified. The mean lesion length was 17.6 cm (range, 10-42 cm). The initial attempt to cross the occlusion with the CTO guidewire V18 was unsuccessful in 26 of 76 limbs (34.26%). A secondary attempt using the Frontrunner catheter (crossover approach, 27%; antegrade, 73%) performed in all 26 failed cases was successful in 17 limbs (65.38%), increasing the technical success rate to 88.12%. The main reasons for failure with the Frontrunner were inability to cross the lesion due to heavy calcification (six of nine) and inability to re-enter the true lumen after subintimal passage of the occluded segment (three of nine). The mean fluoroscopy time was 22.9 min. Minor complications included one distal extension of the dissection with involvement of the first popliteal segment and one perforation in the occluded segment. No major complications were seen. In conclusion, recanalization with the Frontrunner CTO catheter is a simple and safe method with a high technical success rate in the endovascular treatment of long superficial femoral artery occlusions and should be an alternative method after guidewire failure.

Total percutaneous endovascular aneurysm repair with the dual 6-F Perclose-AT preclosing technique: a case-control study.

PURPOSE: To determine the safety and efficacy of total percutaneous access closure for endovascular aortic aneurysm repair with a suture-mediated preclosing technique. MATERIALS AND METHODS: One hundred thirty-two femoral access sites in 70 patients who underwent endovascular aortic aneurysm repair were closed percutaneously with off-label use of two F-6 Perclose AT devices preapplied at a 90 degrees angle. Femoral access sizes ranged from 12 to 24 F. Technical success, complications, and procedure and access closure times were evaluated. Follow-up with computed tomography and/or magnetic resonance imaging was scheduled at 1-4 days and 3, 6, and 12 months and used to obtain groin hematoma and scar severity scores (grades 1-3). Data were compared with those from a cohort of 67 patients who underwent endovascular aortic aneurysm repair with surgical femoral cutdown. RESULTS: Technical success was achieved with the preclosing technique in 127 of the 132 arteries (96.2%). Two to four closure devices were used per groin. Five technical failures were managed intraoperatively with surgical suture. There was no access-related mortality and no late groin complications. The mean procedure duration was 91 minutes +/- 32, and the mean access closure time was 12 minutes +/- 9. For surgical management, the mean procedure time was 153 minutes +/- 112 (P < .05), and the mean closure time was 12 minutes +/- 13 (not statistically significant). Hematoma severity score at 1-4 days was 1.8 for total percutaneous endovascular aneurysm repair and 2.1 for surgical closure. Scar severity scores at 3, 6, and 12 months were 1.1, 1.0, and 1.0 for total percutaneous endovascular aneurysm repair and 2.4, 2.4, and 2.3 for surgical management, respectively. CONCLUSIONS: Total percutaneous endovascular aneurysm repair with a dual 6-F-Perclose preclosing technique is safe and effective. Compared with femoral cutdown, there are fewer late groin complications and scar tissue formation is less severe.

Percutaneous aortic valve replacement: computed tomography scan after valved stent implantation in human cadaver hearts.

Computed tomography scans were performed before and after aortic valve resection with consecutive implantation of a valved stent in human hearts with highly calcified aortic valves in situ (n=2). This demonstrates that the valved stent shows better fitting in the annulus after removal of the native valve.

Embolic protection devices for peripheral application: wasteful or useful?

Distal embolization following percutaneous intervention is a universal phenomenon that has been reported in various vascular beds. Distal emboli are also very common during lower extremity percutaneous peripheral interventions. Some data from case reports and registries are currently available. Clinical data have shown that the application of an embolic protection device in the lower limb arteries is safe. Prospective and, ideally, randomized trial data are warranted to justify the increased use of filters in lower extremity interventions, despite the obvious benefits that these devices provide. However, the clinical relevance of distal embolization in the lower extremity remains unquantified.