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1.
J Endovasc Ther ; 19(6): 707-15, 2012 Dec.
Article in English | MEDLINE | ID: mdl-23210865

ABSTRACT

PURPOSE: To investigate the feasibility and early results of endoanchoring (endostapling) using a new commercially available device as an adjunctive procedure during endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs) with an unfavorable proximal neck. METHODS: Between June 2010 and May 2012, 13 consecutive patients (all men; median age 73 years, range 62-82) were prospectively enrolled in a 2-center registry to follow outcomes of adjunctive primary endoanchoring (Aptus HeliFX Aortic Securement System) of the proximal endograft to enhance proximal graft fixation and sealing during EVAR. Indications for proximal neck endoanchoring included at least one of the following: neck angulation 45° to 90°, length 8 to 15 mm, diameter 29 to 33 mm, conical neck configuration, or an irregularly shaped neck. The median AAA diameter was 56 mm (range 50-98). The Endurant stent-graft was implanted in 4 patients and the Zenith device in 9. RESULTS: A median of 4 endoanchors were implanted per patient (range 3-10) in adjunctive procedures that required a median 12 minutes (range 7-20). Intraoperatively, 2 proximal type I endoleaks were present following endoanchor implantation (85% primary technical success); a cuff was deployed in 1 case, which successfully sealed the endoleak (92% assisted primary technical success). The second proximal type I endoleak was minute and sealed spontaneously within 30 days. No further major device-related complications occurred intraoperatively. In the 30-day perioperative period, the only procedure-related complications were 2 type II endoleaks, which required no intervention. Over a median follow-up of 7 months (range 2-17), no further complications occurred apart from an asymptomatic internal iliac artery occlusion and a non-lethal myocardial infarction at 9 months. The type II endoleaks spontaneously sealed. No endograft migration was noticed nor loss of endoanchor integrity. No deaths occurred throughout follow-up. CONCLUSION: Primary endoanchoring using the HeliFX aortic securement system is feasible, and early results were promising in this series.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/methods , Endovascular Procedures , Surgical Stapling , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortography , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/instrumentation , Endoleak/etiology , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Equipment Design , Feasibility Studies , Female , Humans , Male , Middle Aged , Prospective Studies , Registries , Stents , Surgical Stapling/adverse effects , Surgical Stapling/instrumentation , Sutures , Time Factors , Treatment Outcome
2.
J Vasc Surg ; 55(6): 1726-33, 2012 Jun.
Article in English | MEDLINE | ID: mdl-22322119

ABSTRACT

OBJECTIVE: This study evaluated the contribution of Aptus EndoStaples (Aptus Endosystems, Sunnyvale, Calif) in the proximal fixation of eight endografts used in the endovascular repair of abdominal aortic aneurysms (EVAR). METHODS: Nine human cadaveric aortas were exposed, left in situ, and transected to serve as fixation zones. The Zenith (Cook, Bloomington, Ind), Anaconda (Vascutek, Inchinnan, Scotland, UK), Endurant (Medtronic, Minneapolis, Minn), Excluder (W. L. Gore and Associates, Flagstaff, Ariz), Aptus (Aptus Endosystems), Aorfix (Lombard Medical, Didcot, UK), Talent (Medtronic), and AneuRx (Medtronic) stent grafts were proximally deployed and caudal displacement force (DF) was applied via a force gauge, recording the DF required to dislocate each device ≥20 mm from the infrarenal neck. Measurements were repeated after four and six EndoStaples were applied at the proximal fixation zone, as well as after a Dacron graft was sutured at the proximal neck in standard fashion. Finally, a silicone tube was used as a control fixation zone to test the DF of grafts with EndoStaples in a material that exceeded the integrity of a typical human cadaveric aorta and provided a consistent substrate to examine the differential effect of variable degrees of EndoStaple implantation using zero, two, four, and six EndoStaples. RESULTS: In the cadaveric model, the mean DF required to dislocate the endografts without the application of EndoStaples was 19.73 ± 12.52 N; this increased to 49.72 ± 12.53 N (P < .0001) when four EndoStaples where applied and to 79.77 ± 28.04 N when six EndoStaples were applied (P = .003). The DF necessary to separate the conventionally hand-sutured Dacron graft from the aorta was 56 N. In the silicone tube model, the Aptus endograft without EndoStaples withstood 3.2 N of DF. The DF increased to 39 ± 3 N when two EndoStaples were added, to 71 ± 6 N when four were added, and to 98 ± 5 N when six were added. In eight of the 13 cadaver experiments conducted with four and six EndoStaples, the displacement occurred as a result of complete aortic transection proximal to the fixation site, indicating that aortic tissue integrity was the limiting factor in these experiments. CONCLUSIONS: The fixation of eight different endografts was increased by a mean of 30 N with four Aptus EndoStaples and by a mean of 57 N with six EndoStaples in this model. Endostaples can increase endograft fixation to levels equivalent or superior to that of a hand-sewn anastomosis. The application of six EndoStaples results in aortic tissue failure above the fixation zone, demonstrating fixation strength that exceeds inherent aortic integrity in these cadavers.


Subject(s)
Aorta/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Stents , Suture Techniques/instrumentation , Sutures , Aged , Aged, 80 and over , Blood Vessel Prosthesis Implantation/methods , Cadaver , Equipment Design , Equipment Failure , Humans , Male , Materials Testing , Middle Aged , Prosthesis Design , Prosthesis Failure , Stress, Mechanical
3.
J Vasc Nurs ; 26(1): 15-21, 2008 Mar.
Article in English | MEDLINE | ID: mdl-18295163

ABSTRACT

The study objective was to compare the cost and effectiveness of two surgical techniques: open repair and endovascular aneurysm repair (EVAR) of abdominal aortic aneurysm (AAA). We assessed 58 surgical operations of AAA repair conducted in 54 men and 4 women (aged 49-94 years) during 2003 and 2004. Open surgical repair was performed in 21 patients, and EVAR was performed in 37 patients. The evaluation of the effectiveness of both methods was based on the following factors: mortality within 30 days, surgery duration, total hospitalization time, and intensive care unit stay duration. The segmental costs of grafts, anesthesia, and extra materials were included in the calculations for the comparison of the costs of the two methods. A 30-day mortality of 5.17% and 0% was demonstrated for open surgical repair and EVAR, respectively. In regard to the operation's mean duration, this was calculated to 279.52 minutes for open repair and 193.57 minutes for EVAR. The mean duration of the in-hospital stay was 11.3 and 4.09 days for open repair and EVAR, respectively. Accordingly, the mean duration of intensive care unit stay was 2.81 and 0.23 days, respectively. The cost evaluation revealed a mean cost of 5374.3euro ($7,643.49) and 20,592.52euro ($29,287.50) for open repair and EVAR, respectively. Open repair is a "tested method" of its own time. EVAR seems to have the advantage on aspects of effectiveness, yet its major hallmark is its significant cost, as indicated in the relevant part of the current study.


Subject(s)
Angioplasty/economics , Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/economics , Hospital Costs/statistics & numerical data , Aged , Aged, 80 and over , Angioplasty/mortality , Angioplasty/nursing , Blood Vessel Prosthesis Implantation/mortality , Blood Vessel Prosthesis Implantation/nursing , Chi-Square Distribution , Cost-Benefit Analysis , Critical Care/economics , Female , Health Services Research , Humans , Length of Stay/economics , Male , Middle Aged , Nurse's Role , Retrospective Studies , Time Factors , Treatment Outcome
4.
J Endovasc Ther ; 14(5): 609-18, 2007 Oct.
Article in English | MEDLINE | ID: mdl-17924724

ABSTRACT

PURPOSE: To present a 7-year single-center clinical experience with fenestrated endografts and side branches. METHODS: Between April 1999 and August 2006, 63 patients (57 men; mean age 70.5+/-11.6 years, range 25-89) received custom-designed Zenith fenestrated endoprostheses for a variety of aneurysms (59 abdominal, 1 thoracoabdominal, and 3 thoracic). They were all unsuitable for standard EVAR owing to short aortic necks and high risk for open surgery. RESULTS: Nineteen tube grafts and 44 composite bifurcated grafts with a total of 122 fenestrations and 58 side branches were used. Technical success was achieved in 55 (87.3%) patients and in 118 (96.7%) vessels. Treatment success was 93.7%. The mean follow-up was 23+/-18 months (median 14, range 6-77). Overall, 9 (7.4%) visceral branches were lost: 4 intraoperative, 2 perioperative, and 3 late. There were 12 (19.0%) endoleaks identified: 5 (7.9%: 4 type Ia and 1 fenestration-related type III) primary and 7 (11.1%: 4 type II, 1 type I, and 2 type III) secondary endoleaks; 4 resolved, 4 were treated, and 4 are under observation. At 77 months, 75.3% of patients were free of a reintervention. All reinterventions were performed within the first 14 months. Fourteen cases of renal impairment were seen [6 permanent (only 1 on dialysis) and 8 transient]. One (1.6%) conversion and 1 (1.6%) rupture were recorded; aneurysm-related mortality was 4.8% (3/63). CONCLUSION: The favorable outcomes in this study, which encompasses the team's learning curve with fenestrated endografts and side branches, support the use of these devices in selected patients.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Stents , Adult , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/mortality , Aortic Aneurysm, Abdominal/pathology , Aortic Aneurysm, Thoracic/mortality , Aortic Aneurysm, Thoracic/pathology , Blood Vessel Prosthesis Implantation/adverse effects , Feasibility Studies , Female , Follow-Up Studies , Humans , Kaplan-Meier Estimate , Kidney Diseases/etiology , Male , Middle Aged , Patient Selection , Prosthesis Design , Reoperation , Retrospective Studies , Time Factors , Treatment Outcome
5.
Ann Vasc Surg ; 21(1): 117-21, 2007 Jan.
Article in English | MEDLINE | ID: mdl-17349348

ABSTRACT

Carotid body tumors (CBTs) are rare neoplasms. Excision is the preferred treatment and is associated with low mortality and morbidity, although rates of cranial nerve dysfunction postoperatively and blood loss are still high. We herein present a case of a huge CBT, Shamblin group 3, managed successfully by the use of the Cavitral Ultrasonic Surgical Aspirator after preoperative superselective embolization. Our goal was to minimize the possibility of cranial nerve injury, blood loss, and vascular reconstruction. Careful preoperative evaluation, management, and intraoperative precision are essential for successful outcomes. Ultrasonic dissection of a CBT allows a precise and energy-controlled approach, minimizing intraoperative complications in such a demanding and delicate operation.


Subject(s)
Carotid Body Tumor/surgery , Ultrasonic Therapy , Carotid Body Tumor/diagnosis , Combined Modality Therapy , Embolization, Therapeutic , Humans , Male , Middle Aged , Tomography, X-Ray Computed
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