Comparison of Two Iliac Branch Devices and Their Midterm Performance in Maintaining Blood Flow to the Internal Iliac Artery.

Purpose: To compare and contrast the midterm outcomes of the E-liac and Zenith (ZBIS) iliac branch devices (IBDs) for the preservation of the internal iliac artery (IIA) in aneurysms involving the iliac bifurcation. Materials and Methods: Between January 2014 and December 2018, 84 consecutive patients (median age 74 years; 76 men) were electively treated with the E-liac (n=44) or ZBIS (n=40) IBDs and were retrospectively analyzed to evaluate the technical success, patency, need for reintervention, and mortality associated with these devices. Results: Technical success was achieved in 95 of 99 implantations (95.9%) without any statistically significant difference between the groups (93.7% vs 98.0%, p=0.114). During the first 30 days, 3 occlusions in the ZBIS group and 1 in the E-liac group were identified. There was 1 perioperative death in the ZBIS group. The median follow-up was 37 months for the ZBIS group and 28 months for the E-liac group (p=0.657). Six patients from the ZBIS group and 7 from the E-liac group were lost to follow-up. Among the remaining, there were 2 further deaths recorded, 1 in each group. Four further reinterventions in the E-liac group and 2 in the ZBIS group were performed during follow-up. The Kaplan-Meier estimates of freedom from reintervention were 87.2% (95% CI 82.6% to 90.2%) for the ZBIS group and at 86.0% (95% CI 83.7% to 89.1%) for the E-liac group (p=0.563); the freedom from occlusion estimates were 89.7% (95% CI 85.8% to 94.5%) and 95.3% (95% CI 92% to 98.7%; p=0.317), respectively. Conclusion: The E-liac and the ZBIS IBDs showed equally high technical success, midterm patency, and low reintervention rates.

Prospective Study of the Iliac Branch Device E-liac in Patients with Common Iliac Artery Aneurysms: 12 Month Results.

OBJECTIVES: At 12 months follow up of the PLIANT study, clinical success and efficacy of the E-liac Stent Graft System (JOTEC GmbH, Hechingen, Germany) were evaluated. Clinical success was defined as aneurysm exclusion (no type I, III, IV endoleak) with primary patency of the internal iliac artery (IIA) and external iliac artery (EIA) on the E-liac implantation side. METHODS: In this prospective multicentre European observational study, clinical and morphological data of 45 patients (93% male, mean age 72 y) were prospectively collected in 11 European centres between July 2014 and June 2016. Forty patients underwent an aorto-iliac (three patients bilaterally) treatment and five an isolated iliac treatment. RESULTS: At 12 months follow up, data were available for 42 patients. Overall clinical success at 12 months was 90%, with a survival rate of 100%. Four patients (10%) did not achieve clinical success, one with an internal iliac artery (IIA) occlusion on the E-liac implantation side, one with an infrarenal type Ia endoleak, and two with type Ib endoleaks in IIA. At 12 months the primary patency rate in the internal iliac artery on the iliac side branch implantation side was 98%. Two patients (5%) received E-liac related re-interventions: one caused by an edge stenosis at the distal end of the graft limb in the external iliac artery (EIA) and one caused by thrombo-embolism in the external iliac artery. Thus, for the EIA, primary and secondary patency rates were 98% and 100%, respectively. CONCLUSIONS: The low device related re-intervention rate of 5%, the high survival rate of 100%, and the high primary patency rates of 98% for the IIA and EIA at 12 month follow up demonstrate the safety and efficacy of the E-liac Stent Graft System. Long term 36 month results are awaited to confirm the efficacy and durability.

Patients Older Than 80 Years Can Reach Their Normal Life Expectancy After Abdominal Aortic Aneurysm Repair: A Comparison Between Endovascular Aneurysm Repair and Open Surgery.

PURPOSE: To investigate the long-term outcomes of endovascular aneurysm repair (EVAR) and open surgical repair (OSR) of infrarenal abdominal aortic aneurysm in octogenarian patients and to compare them with the overall expected survival based on a sex- and age-matched German population. METHODS: A total of 177 patients (median age 82 years; 149 men) ≥80 years old (range 80-92) who underwent primary elective repair of an infrarenal aortic aneurysm (≥5 cm) between 1998 and 2015 were identified in a database search. Two groups of patients were formed based on the type of procedure: 131 EVAR patients (median age 83 years; 114 men) and 46 OSR patients (median age 82 years; 35 men). RESULTS: The median follow-up was 5 years for the OSR group and 4.5 years for the EVAR group. Kaplan-Meier analysis showed no significant difference in survival between the EVAR and OSR groups at 78 months. The observed survival of all study patients was not statistically different from the expected survival of a sex- and age-matched German population, which was true separately for women and men. CONCLUSION: The patients in this study seemed to reach normal life expectancy in comparison to the age- and sex-matched general population with a similar cumulative survival in both study groups over 5 years of follow-up.

Safety and effectiveness of the INCRAFT AAA Stent Graft for endovascular repair of abdominal aortic aneurysms.

OBJECTIVE: This study evaluated the 2-year safety and effectiveness of the European First-in-Human INNOVATION trial for the INCRAFT AAA Stent Graft system (Cordis Corp, Bridgewater, NJ), an ultra-low-profile device for the treatment of abdominal aortic aneurysms. METHODS: From March 2010 to June 2011, the INNOVATION prospective multicenter trial involving six centers in Europe enrolled and treated 60 asymptomatic patients (95% male; mean age, 74.4 ± 6.9 years) with the INCRAFT System. Main inclusion criteria included proximal aortic neck length of 15 mm or more with a diameter up to 27 mm; distal iliac landing zones with a length greater than 10 mm and a diameter between 9 and 18 mm; and aortic bifurcation >18 mm in diameter and access vessels large enough to accept the 14F outer diameter of the delivery system. The primary end point was technical success at 1 month; 2-year safety end points included the absence of device- or procedure-related major adverse events, absence of type I or III endoleaks, and maintenance of device integrity through 2 years of follow-up. Study oversight was provided by a Data Safety Monitoring Board with event adjudication by a Clinical Events Committee and imaging analysis by an independent core laboratory. RESULTS: Of 60 successfully treated patients, two did not come back for their 1-month evaluation but remained enrolled in the study; 56 were evaluated at 1 year and 52 at 2 years. Of the 58 patients, 56 met the 1-month primary safety and effectiveness end point (97%; 95% confidence interval, 88%-100%). All patients were free from aneurysm enlargement through 2 years. There were no type I or III endoleaks at the 2-year time point. All-cause mortality at 2 years was 11.5%, and no death was device or procedure related. In total, three patients required a postprocedure intervention, two to repair a type I endoleak and one for limb occlusion. Core laboratory evaluation of the postoperative imaging studies documented absence of endograft migration and stent fractures in all patients. CONCLUSIONS: The INCRAFT AAA Stent Graft System provides a durable solution for patients with abdominal aortic aneurysms, with a low frequency of device-related events through 2 years of follow-up.

First-in-human study of the INCRAFT endograft in patients with infrarenal abdominal aortic aneurysms in the INNOVATION trial.

OBJECTIVE: This multicenter, prospective, nonrandomized trial was undertaken to evaluate the first-in-human experience with the INCRAFT endograft (Cordis Corporation, Bridgewater, NJ), an ultralow-profile trimodular bifurcate device for the repair of abdominal aortic aneurysms. METHODS: Patients with asymptomatic infrarenal abdominal aortic aneurysms were eligible for enrollment in the trial. Anatomic eligibility criteria included a proximal aortic neck at least 15 mm in length and up to 27 mm in diameter, and an aortic bifurcation ≥18 mm in diameter. Iliofemoral access vessels were required to be large enough to accept the 14F (4.7 mm) outer diameter of the delivery system. The primary efficacy end point was technical success, defined by successful device deployment during the conclusion of the procedure at the desired location without a type I, III, or IV endoleak. The primary safety end point was defined by the absence of a type I, III, or IV endoleak or a device- or procedure-related major adverse event at the 1-month follow-up point. RESULTS: Over a 16-month period divided into two different phases, 57 men and three women with a mean age of 74.4 ± 6.9 years were enrolled at three German and three Italian centers. A percutaneous approach was used in 36 patients (60%). Successful graft deployment at the desired location was achieved in 59 patients (98%). A single patient had successful deployment of the device although it was located more distally than planned. Technical success was achieved in 54 patients (90%); one patient had a type I endoleak, four had type IV endoleaks, and one had an endoleak of undetermined origin. The primary safety end point was met in 56 of the 58 patients (97%) with complete core laboratory data at 1 month; two patients had type I endoleaks. There were no type III or IV endoleaks and no device or procedure-related major adverse events at 1 month. No limb thromboses or stent fractures were noted on postoperative imaging studies and no patient required rehospitalization, a secondary procedure, or open surgical conversion through 1 month of follow-up. CONCLUSIONS: The INCRAFT endograft device holds promise as an innovative alternative to currently marketed devices and broadens the eligibility for endovascular aneurysm repair. More definitive observations will be generated as longer-term data from this trial become available.

Collected world and single center experience with endovascular treatment of ruptured abdominal aortic aneurysms.

BACKGROUND: Case and single center reports have documented the feasibility and suggested the effectiveness of endovascular aneurysm repair (EVAR) of ruptured abdominal aortic aneurysms (RAAAs), but the role and value of such treatment remain controversial. OBJECTIVE: To clarify these we examined a collected experience with use of EVAR for RAAA treatment from 49 centers. METHODS: Data were obtained by questionnaires from these centers, updated from 13 centers committed to EVAR treatment whenever possible and included treatment details from a single center and information on 1037 patients treated by EVAR and 763 patients treated by open repair (OR). RESULTS: Overall 30-day mortality after EVAR in 1037 patients was 21.2%. Centers performing EVAR for RAAAs whenever possible did so in 28% to 79% (mean 49.1%) of their patients, had a 30-day mortality of 19.7% (range: 0%-32%) for 680 EVAR patients and 36.3% (range: 8%-53%) for 763 OR patients (P < 0.0001). Supraceliac aortic balloon control was obtained in 19.1% +/- 12.0% (+/-SD) of 680 EVAR patients. Abdominal compartment syndrome was treated by some form of decompression in 12.2% +/- 8.3% (+/-SD) of these EVAR patients. CONCLUSION: These results indicate that EVAR has a lower procedural mortality at 30 days than OR in at least some patients and that EVAR is better than OR for treating RAAA patients provided they have favorable anatomy; adequate skills, facilities, and protocols are available; and optimal strategies, techniques, and adjuncts are employed.

The INNOVATION Trial: four-year safety and effectiveness of the INCRAFT® AAA Stent-Graft System for endovascular repair.

BACKGROUND: This paper reports the 4-year safety and effectiveness of the INCRAFT® AAA Stent-Graft System (Cordis Corp., Milpitas, CA, USA), an ultra-low-profile device for the treatment of abdominal aortic aneurysms. METHODS: The INNOVATION Trial is the prospective, first-in-human, multicenter trial to evaluate the safety and effectiveness of the INCRAFT® System. Patients underwent annual clinical and computed tomography angiography examination as part of the study protocol. The INCRAFT® AAA Stent-Graft System is a customizable tri-modular design, with an ultra-low profile (14-Fr) delivery system. Patient were treated under approved protocol, the prescribed clinical and imaging follow-up at annually through 5 years. Results analyzed and adjudicated by a clinical events committee, independent core laboratory, and a data safety and monitoring board. This manuscript reports results through 4 years of follow-up. RESULTS: A total of 60 patients were enrolled in the trial, all of whom were successfully treated. Follow-up rates at 1 and 4 years were 93% (56/60) and 85% (51/60), respectively. All-cause mortality at 4 years was 17.6% and no death was AAA-, device-, or procedure-related. The secondary reintervention rate at 1 year was 4.6%, primarily the result of stent thrombosis. In total, 10 patients required 13 post-procedure interventions within 4-years of follow-up (2 to repair a type I endoleak, 4 to repair a type II endoleak, 1 for stent thrombosis, 1 for renal stenosis, 1 for aneurysm enlargement, 2 for limb migration and 2 for prosthesis stenosis or occlusion). There were 4 cases (10%) of aneurysm enlargement reported at the 4 year follow-up. At 4 years, 38 out of 39 patients were free from type I and III endoleaks. There were no proximal type I or type III endoleaks at 4-year follow-up. Core laboratory evaluation of the postoperative imaging studies indicated absence of endograft migration while a single fracture was demonstrated without any clinical sequelae. CONCLUSIONS: The INCRAFT® AAA Stent-Graft System provides a minimally invasive and durable solution for patients undergoing EVAR that has been associated with a low frequency of device-related events through 4 years of follow-up.