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: Abdominal aortic aneurysms (AAAs) are a vascular condition with significant risk attached, particularly if they rupture. It is, therefore, critical to identify and repair these as an elective procedure before they rupture and require emergency surgery. Repair has traditionally been an open surgical technique that required a large incision across the abdomen. More recently endovascular aneurysm repairs (EVARs) have become a common alternative. In this procedure, the common femoral artery is exposed via a cut-down approach and a graft is introduced to the aneurysm in this way. This review examines a totally percutaneous approach to EVAR. This technique gives a minimally invasive approach to femoral artery access that may reduce groin wound complication rates and improve recovery time. The technique may, however, be less applicable in patients with, for example, groin scarring or arterial calcification. This review aims to compare the clinical outcomes of percutaneous access with standard femoral artery access in elective bifurcated abdominal endovascular aneurysm repair (EVAR). The Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched their Specialised Register (last searched July 2013), CENTRAL (2013, Issue 6) and clinical trials databases. Reference lists of retrieved articles were checked. Only randomised controlled trials were considered. The primary intervention was a totally percutaneous endovascular repair. All device types were considered. This was compared against standard femoral artery endovascular repair. Only studies investigating elective repairs were considered. Studies reporting emergency surgery for a ruptured abdominal aortic aneurysm (rAAA) and those reporting aorto-uni-iliac repairs were excluded. All data were collected independently by two review authors. Owing to the small number of trials identified, no formal assessment of heterogeneity or sensitivity analysis was conducted. Only one trial met the inclusion criteria, involving a total of 30 participants, 15 undergoing the percutaneous technique and 15 treated by the standard femoral cut-down approach. There were no significant differences between the two groups at baseline.No mortality or failure of aneurysm exclusion was observed in either group. Three wound infections occurred in the standard femoral cut-down group, whereas none were observed in the percutaneous group. This was not statistically significant. Only one major complication was observed in the study, a conversion to the cut-down technique in the percutaneous access group. No long-term outcomes were reported. One episode of a bleeding complication was reported in the percutaneous group. Significant differences were detected in surgery time (percutaneous 86.7 ± 27 minutes versus conventional 107.8 ± 38.5 minutes; P < 0.05).The included study had a small sample size and failed to report adequately the method of randomisation, allocation concealment and the pre-selected outcomes. Only one small study was identified, which did not provide adequate evidence to determine the efficacy and safety of the percutaneous approach compared with endovascular aneurysm repairs. This review has identified a clear need for further research into this potentially beneficial technique. One ongoing study was identified in the search, which may provide an improved evidence base in the future.Cochrane database of systematic reviews (Online) 02/2014; 2:CD010185. · 5.94 Impact Factor
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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; 119(11). · 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