Total percutaneous endovascular repair of abdominal aortic aneurysms using Perclose ProGlide closure devices.
ABSTRACT 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.
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).
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.
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ABSTRACT: This study evaluated the feasibility and safety of percutaneous endovascular aneurysm repair (P-EVAR) in an "unselected" population of patients using Prostar XL closure device, comparing our results with the literature data reported for open EVAR (O-EVAR) and P-EVAR in selected populations. We prospectively enrolled 200 patients with abdominal aortic aneurysms to be treated with the P-EVAR procedure, without any selection criteria. Four hundred percutaneous femoral accesses using the Prostar XL closure device were performed. The early follow-up protocol consisted of a Doppler ultrasound (US) examination. Later evaluations were performed with US and computed tomography. Technical success was achieved in all percutaneous accesses (100 %). Ten early complications related to access site were recorded (10/400; 2.5 %): four pseudoaneurysms and six cases of lower limb ischaemia. Five of ten complications occurred in patients presenting calcification of the common femoral arteries, whereas 4/10 were in patients with "complex" groin anatomy. Eight of ten complications occurred at the access site of the main body of the prosthesis using a sheath size >20 Fr. Percutaneous endovascular aneurysm repair in "unselected" patients is safe and efficient, with a very low risk of access-related complications, comparable to P-EVAR in selected populations and to the best O-EVAR series.La radiologia medica 04/2014; · 1.37 Impact Factor
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ABSTRACT: The first multicenter randomized controlled trial was designed and conducted to assess the safety and effectiveness of totally percutaneous endovascular aortic aneurysm repair (PEVAR) with use of a 21F endovascular stent graft system and either an 8F or 10F suture-mediated closure system (the PEVAR trial, NCT01070069). A noninferiority trial design was chosen to compare percutaneous access with standard open femoral exposure. Between 2010 and 2012, 20 U.S. institutions participated in a prospective, Food and Drug Administration-approved randomized trial to evaluate percutaneous femoral artery access and closure by a "preclose" technique in conjunction with endovascular abdominal aortic aneurysm repair. A total of 151 patients were allocated by a 2:1 design to percutaneous access/closure (n = 101) or open femoral exposure (n = 50 [FE]). PEVAR procedures were performed with either the 8F Perclose ProGlide (n = 50 [PG]) or the 10F Prostar XL (n = 51 [PS]) closure devices. All endovascular abdominal aortic aneurysm repair procedures were performed with the Endologix 21F profile (outer diameter) sheath-based system. Patients were screened by computed tomography with three-dimensional reconstruction and independent physician review for anatomic suitability and adequate femoral artery anatomy for percutaneous access. The primary trial end point (treatment success) was defined as procedural technical success and absence of major adverse events and vascular complications at 30 days. An independent access closure substudy evaluated major access-related complications. Clinical utility and procedural outcomes, ankle-brachial index, blood laboratory analyses, and quality of life were also evaluated with continuing follow-up to 6 months. Baseline characteristics were similar among groups. Procedural technical success was 94% (PG), 88% (PS), and 98% (FE). One-month primary treatment success was 88% (PG), 78% (PS), and 78% (FE), demonstrating noninferiority vs FE for PG (P = .004) but not for PS (P = .102). Failure rates in the access closure substudy analyses demonstrated noninferiority of PG (6%; P = .005), but not of PS (12%; P = .100), vs FE (10%). Compared with FE, PG and PS yielded significantly shorter times to hemostasis and procedure completion and favorable trends in blood loss, groin pain, and overall quality of life. Initial noninferiority test results persist to 6 months, and no aneurysm rupture, conversion to open repair, device migration, or stent graft occlusion occurred. Among trained operators, PEVAR with an adjunctive preclose technique using the ProGlide closure device is safe and effective, with minimal access-related complications, and it is noninferior to standard open femoral exposure. Training, experience, and careful application of the preclose technique are of paramount importance in ensuring successful, sustainable outcomes.Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter 01/2014; · 2.98 Impact Factor
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ABSTRACT: The "Preclose technique" using a perclose device has recently become widely used in various percutaneous procedures requiring a large access sheath. However, the post-procedural application of the perclose™ to the large sheath arteriotomy is more challenging because of the risk of bleeding and difficulty of device application. This report introduces a novel post-procedural closing technique of large 22 French arterial sheath access using perclose devices. © 2013 Wiley Periodicals, Inc.Catheterization and Cardiovascular Interventions 09/2013; · 2.51 Impact Factor