RS03. A Matched Cohort Comparison of Outcomes in Patients Who Underwent Fenestrated Endovascular Aortic Aneurysm Repair Using Physician-Modified Endovascular Grafts vs Company-Manufactured Devices

Abstract

Fenestrated endografts are customized, patient-specific, endovascular devices with the potential to reduce morbidity and mortality of repair of complex aortic aneurysms. With approval from the United States Food and Drug Administration, our center began performing fenestrated endovascular aneurysm repair through a physician-sponsored investigational device exemption (IDE #G130210), using both physician-modified endografts (PMEG) and company manufactured devices (CMD). Because PMEG and CMD are each associated with specific advantages and disadvantages, we sought to investigate differences in outcomes between PMEG and CMD cases. A single-institution retrospective review of all fenestrated endovascular aneurysm repairs was performed. The cohort was analyzed according to device type (PMEG or CMD) after matching cases based on (1) number of target vessels intended for treatment, (2) extent of aneurysm, (3) aneurysm diameter, (4) device configuration, and (5) date of operation. Outcomes of ruptures, common iliac, and arch aneurysms were excluded. Demographics, operative details, perioperative complications, length of stay, and reinterventions were compared. For patients with >1-year follow-up time, survival, type I or type III endoleak rate, target artery patency, and reintervention rate were analyzed using the Kaplan-Meier method. Between November 30, 2010, and July 30, 2016, 82 patients were identified and matched. The cohort included 41 PMEG and 41 CMD patients who underwent repair of 38 juxtarenal (PMEG, 17; CMD, 21), 14 pararenal (PMEG, 6; CMD, 8), and 30 thoracoabdominal types 1 to 4 (PMEG, 18; CMD, 12) aneurysms. There were significant differences in urgency of presentation (PMEG, 9; CMD, 0; P = .002), total fluoroscopy time (PMEG, 76 minutes; CMD, 61 minutes; P = .02), volume of contrast used (PMEG, 88 mL; CMD, 70 mL; P = .02), in-operating room to out-of-operating room time (PMEG, 391 minutes; CMD, 319 minutes; P = .001), incision-to-surgery-end time (PMEG, 276 minutes; CMD, 224 minutes; P = .002; Table), and 1-year reintervention rate (PMEG, 37%, CMD, 13%; log-rank P = .04; Fig). No differences in perioperative complications, overall length of stay, type I or III endoleak, or survival were observed between PMEG vs CMD. In this single-institution experience of fenestrated endovascular aneurysm repair, the primary differences between PMEG and CMD related only to operative technique and postoperative reinterventions. No clear benefit was associated with one approach over the other, suggesting that both are viable options that may offer benefit compared with open repair of complex aortic aneurysms. Further studies are necessary to determine if this relative equivalence represents a type 2 error and/or lack of long-term durability data or if true equivalence between PMEG and CMD approaches exists.TableOperative characteristics of patients who underwent complex endovascular aneurysm repair with physician-modified endografts (PMEG) or company-manufactured devices (CMD) between 2010 and 2016aVariablesPMEG (n = 41)CMD (n = 41)P valueTarget arteries incorporated in repair (No.)3.3 (0.69)3.2 (0.82).47Stented fenestrations or branches (No.)2.6 (0.95)2.6 (0.95).99Stents placed for target arteries (No.)2.6 (1.3)2.8 (1.2).43Fluoroscopy time (min)76 (35)61 (19).02Dose area product (mGy · cm2)84,087 (39,751)55,211 (47,306).32Exam dose (mGy)5192 (3,462)4277 (2371).18Volume of contrast used (mL)88 (42)70 (21).02Operative times (min) In operating room to incision91 (35)76 (23).02 Incision to surgery end276 (81)224 (59).002 In operating room to out of room391 (104)319 (73).001Operating room direct cost ($)b32,802 (16,314)31,642 (14,672).74Length of stay Intensive care unit1.7 (2.5)0.68 (1.3).02 Hospital (median, range)3 (1, 6)2 (2, 3).12aData are reported as means with standard deviations, unless otherwise noted.bFor patients who underwent a staged procedure with PMEG (n = 3) or CMD (n = 2), operating room direct cost included total operating room costs for both stages of the repair. Costs attributed to operating room usage time were not included in the total cost calculation. Open table in a new tab