Open Surgical Conversion Research Articles

Preliminary results of endovascular aneurysm sealing from the multicenter Italian Research on Nellix Endoprosthesis (IRENE) study

ObjectiveBecause of advances in technology and experience of the operator, endovascular aneurysm repair (EVAR) has supplanted open repair to treat abdominal aortic aneurysm (AAA). The low 30-day mortality and morbidity of EVAR make the endovascular approach particularly suitable for patients at high surgical risk. However, endoleak or endograft migration requiring secondary intervention or open surgical conversion is a limitation of EVAR. The Nellix system (Endologix, Inc, Irvine, Calif) has been designed to seal the entire AAA to overcome these limitations with EVAR. We report the results of a retrospective, multicenter study with endovascular aneurysm sealing (EVAS) aimed to assess technical success, procedure-related mortality, complications, and reinterventions. MethodsThis study included patients selected for elective treatment with the Nellix device per the endovascular repair protocol at 16 Italian vascular centers. All patients were enrolled in a postoperative surveillance imaging program including duplex ultrasound investigations, computed tomography, and magnetic resonance controls following local standards of care. ResultsFrom 2013 to 2015, there were 335 patients (age, 75.5 ± 7.4 years; 316 men) who underwent elective EVAS. In 295 cases (88.0%), EVAS was performed under standard instructions for use of the Nellix system. Preoperative aneurysm diameter was 55.5 ± 9.4 mm (range, 46-65 mm). The inferior mesenteric artery and lumbar arteries emerging from the AAA were patent in 61.8% and 81.3% of cases, respectively. Chimney grafts were electively carried out in eight cases (2.4%). One (0.3%) intraprocedural type IB endoleak was observed and promptly corrected. Device deployment was successful in all patients, with no perioperative mortality. Early (≤30 days) complications included 1 (0.3%) type IA endoleak, 2 (0.6%) type II endoleaks (0.6%), 2 (0.6%) stent occlusions (0.6%), 3 (0.9%) distal embolizations, and 2 (0.2%) femoral artery dissections. Six (2.9%) patients underwent reinterventions. At 1-year follow-up, complications included 3 (1.1%) type II endoleaks, 4 (1.4%) type IA endoleaks, 1 (0.3%) type IB endoleak, 2 (0.7%) distal stent migrations, 5 (1.8%) distal embolizations, and 1 (0.3%) stent occlusion. Twelve patients (3.7%) underwent reinterventions, including four (1.4%) surgical conversions due to aortoduodenal fistula (1), endograft infection (1), and type IA endoleak that was unsuccessfully treated percutaneously (2). Two AAA-related deaths occurred. Freedom from aneurysm-related reintervention was 98.3% at 1-month and 94.7% at 12-month follow-up. ConclusionsThe preliminary results of this real-world multicenter study showed that EVAS with Nellix for the management of AAAs appears feasible. This device platform is associated with acceptable procedure-related mortality and low overall complication and reintervention rates. Definitive conclusions on the value of this novel device await long-term follow-up data.

Editor's Choice – Late Open Surgical Conversion after Endovascular Abdominal Aortic Aneurysm Repair

Late open surgical conversion following endovascular aneurysm repair (EVAR) may occur more frequently after performing EVAR in anatomy outside the instructions for use (IFU). This study reviews predictors and outcomes of late open surgical conversion for failed EVAR. This retrospective cohort study reviewed all EVARs performed at the Ottawa Hospital between January 1999 and May 2015. Open surgical conversions >1 month post EVAR were identified. Variables analysed included indication for conversion, pre-intervention AAA anatomy, endovascular device and configuration, operative technique, re-interventions, complications, and death. Of 1060 consecutive EVARs performed, 16 required late open surgical conversion. Endografts implanted were Medtronic Talent (n = 8, 50.0%), Medtronic Endurant (n = 3, 18.8%), Cook Zenith (n = 4, 25.0%), and Terumo Anaconda (n = 1, 6.2%). Eleven grafts were bifurcated (68.8%), five were aorto-uni-iliac (31.2%). The median time to open surgical conversion was 3.1 (IQR 1.0-5.2) years. There was no significant difference in pre-EVAR rupture status (1.4% elective, 2.1% ruptured, p=.54). Indications for conversion included: Type 1 endoleak with sac expansion (n=4, 25.0%), Type 2 endoleak with expansion (n=2, 12.5%), migration (n=3, 18.8%), sac expansion without endoleak (n=2, 12.5%), graft infection (n=3, 18.8%), rupture (n=2, 12.5%). Nine patients (56.2%) underwent stent graft explantation with in situ surgical graft reconstruction, seven had endograft preserving open surgical intervention. The 30 day mortality was 18.8% (n=3, all of whom having had endograft preservation). Ten patients (62.5%) suffered major in hospital complications. One patient (6.5%) required post-conversion major surgical re-intervention. IFU adherence during initial EVAR was 43.8%, versus 79.0% (p<.01) among uncomplicated EVARs. Open surgical conversion following EVAR results in significant morbidity and mortality. IFU adherence of EVARs later requiring open surgical conversion is markedly low. More data are required to elucidate the impact of increasing liberalisation of EVAR outside of IFU.

Late Complication after Thoracic Endovascular Aortic Repair: What Is the Role of an Open Surgical Conversion?

The aim was to evaluate the causes of thoracic endovascular aortic repair (TEVAR) failure and conversion to open surgery (COS) in a vascular center with high-volume open surgery and low-volume TEVAR procedures. A total of 8 patients (6 men; mean age, 55.14years) underwent COS after TEVAR. The indications for COS, intraoperative strategy, and early postoperative and mid-follow-up results were analyzed. The indications for COS were persistent proximal type I endoleak with progressive aneurysm enlargement in 2 patients, type III endoleak in 1 patient, progressive aneurysm enlargement with no endoleak in 1 patient, stent-graft migration in 2 patients, secondary aortoesophageal fistula in 1 patient, secondary aortoesophageal and aortobronchial fistula in 1 patient, and distal progression of the aneurysmal disease in 2 patients. In all but one patient, thoracic stent grafts were explanted, and replacement with a Dacron graft was performed using left partial cardiopulmonary bypass. In the remaining patients with disconnection of the distal component and unfavorable anatomy, the proximal stent graft was recycled, and the Dacron prosthesis was sewn to it. Patients with secondary aortobronchial and aortoesophageal fistulas required additional bronchial and esophageal repair. The in-hospital mortality rate was 50% (4 patients). Four (50%) patients were followed up between 7 and 24months (mean, 16.75months) without mortality. COS after TEVAR has a high mortality rate, and endovascular techniques should be considered as the first line of treatment. Those procedures should be performed by surgeons experienced in open repair which one might expect to be a challenging problem in the era of endovascular therapy.

Incidence, etiology, and management of type III endoleak after endovascular aortic repair

ObjectiveThe objective of this study was to retrospectively assess the incidence, etiology, and management of type III endoleaks in a large cohort of patients treated with endovascular aneurysm repair (EVAR) in two European university centers. MethodsFrom 1995 until 2014, 965 EVAR procedures were performed with use of first- and second-generation (n = 79) or third-generation (n = 886) endografts. Radiologic follow-up was performed with computed tomography and abdominal plain film examinations in accordance with the European Collaborators on Stent/graft Techniques for aortic Aneurysm Repair (EUROSTAR) scheme. The potential relationship between the type of endograft and the incidence of type III endoleak and the time interval between initial EVAR and diagnosis of type III endoleak were calculated. ResultsTwenty patients (2.1%) were identified with 25 type III endoleaks (n = 10/79 [12.7%] for first- and second-generation endografts and n = 10/886 [1.2%] for third-generation endografts; P < .001). Disconnection was found in 14 of 25 endoleaks (56%) and a fabric defect in 11 of 25 (44%) endoleaks, both without any difference between first- and second- vs third-generation endografts (P = .216). The time interval between initial EVAR and type III endoleak was 3.87 and 5.92 years, respectively, for first- or second-generation and third-generation endografts (P = .148). Twenty-five type III endoleaks were treated using endovascular techniques (n = 22 [88%]) or by open surgical conversion (n = 3 [12%]). ConclusionsType III endoleak rarely (2.1%) occurs after EVAR, with a higher incidence in first- and second-generation endografts. In the majority of cases, the underlying mechanism is disconnection of the stent graft components. Type III endoleaks may occur early or late after initial EVAR and can, in most cases, be managed endovascularly, although type III endoleak may recur.

The PETTICOAT Technique for Complicated Acute Stanford Type B Aortic Dissection Using a Tapered Self-Expanding Nitinol Device as Distal Uncovered Stent

Provisional Extension To Induce Complete Attachment (PETTICOAT) technique has shown good results in the treatment of acute type B aortic dissections (ABAD). Usually, uncovered tubular stainless steel stents are used to promote distal true lumen reattachment. We describe the Petticoat technique using a conic self-expanding nitinol device as distal uncovered stent in five cases of complicated ABAD. We used as distal uncovered stent the single-flared E-XL (Jotec-GmbH). In one case, renal arteries were successfully stented throughthe large cells of the E-XL. No perioperative complications were reported. During follow-up (18-24months), positive remodeling of the entire aorta occurred in 3 cases; in 1 case with associated thoracoabdominal aneurysm, false lumen thrombosis at the thoracic level with true lumen expansion at the visceral aorta was detected at the 18-month CT angiogram, and in 1 patient with Marfan syndrome, open surgical conversion with the E-XL explantation was performed after 24months due to aneurysmal evolution at the visceral level. The E-XL can be successfully used in ABAD. It adapts to different aortic diameters, and its major radial force promotes successful positive remodeling. The open cell structure allows visceral arteries stenting, and it can be removed without complications during open conversion.

Late Open Surgical Conversion After Endovascular Abdominal Aortic Aneurysm Repair: A Review of 15 Years of Experience

Late open conversion following endovascular aneurysm repair (EVAR) represents a failure of therapy, used to treat complications refractory to secondary endovascular intervention. With liberalization of EVAR and expansion to populations outside of instructions for use (IFU), it is imperative to better understand predictors and to prevent this outcome. The objective of this study was to understand the patterns of presentation, graft-specific differences, outcomes of interventions, and relationship to IFU adherence among patients who underwent late open conversion of EVAR. Records of 1038 consecutive patients who underwent EVAR at The Ottawa Hospital between October 2000 and May 2015 were reviewed from a prospective database. Patients requiring conversion to open repair >1 month after implantation were identified. Patients who underwent fenestrated, branched, or thoracic endovascular repair were excluded. Variables analyzed included date of interventions, adherence to IFU, graft type, interval to open conversion surgery, reason for removal, operative technique, length of stay, hospital complications, and death. A total of 16 patients underwent EVAR that required subsequent late conversion to open repair. Initial grafts implanted included Medtronic (Santa Rosa, Calif) Talent (eight patients, 50.0%), Medtronic Endurant (three patients, 18.8%), Cook (Bloomington, Ind) Zenith (four patients, 25.0%), and Terumo (Somerset, NJ) Anaconda (one patient, 6.2%). Average time to intervention was 3.3 ± 2.5 years, and this interval decreased during the study period (4.6 ± 3.0 years for EVARs before 2007 vs 2.89 ± 1.37 years for EVARs after 2009). Indications for conversion were graft infection in four patients (25%), aneurysm rupture in two patients (12.5%), endograft migration in three patients (18.8%), sac expansion secondary to type Ia endoleak in three patients (18.8%), sac expansion secondary to type II endoleak in two patients (12.5%), and sac expansion without detectable endoleak in two patients (12.5%). Nine patients (56.2%) underwent open conversion by stent graft explantation with in situ graft reconstruction; the remaining seven patients were treated with open cerclage of the aneurysm sac around the device. The 30-day mortality was 18.8%. Major in-hospital complications occurred in 10 patients (62.5%). An additional two patients (12.5%) required postconversion surgical reintervention. During initial EVAR, operators were adherent to device IFU in seven cases (43.8%), which is markedly lower than IFU adherence rates of 88.0% among uncomplicated EVARs in our database. Conversion to open repair following EVAR is associated with significant morbidity and mortality. The rate of operator adherence to IFU at time of initial EVAR in this cohort of open conversions is markedly low in comparison to the overall EVAR cohort. The decreasing interval to open conversion is concerning and may be a reflection of increasing liberalization of EVAR to populations outside of IFU.

開腹手術に移行した腹部大動脈ステントグラフト内挿術後type Ia エンドリークの1 例

開腹手術に移行した腹部大動脈ステントグラフト内挿術後type Ia エンドリークの1 例

Surgical conversion with graft salvage as a definitive treatment for persistent type II endoleak causing sac enlargement

The goal of this study was to present open surgical conversion with graft salvage or "semiconversion" as a definitive and safe treatment for untreatable and persistent type II endoleaks causing sac enlargement after endovascular aneurysm repair. Between January 2001 and December 2014, 25 of 1623 endovascular aortic repair (EVAR) patients were selected as candidates for open semiconversion. The indication was persistent type II endoleak in 13 patients (12 of whom received previous attempts of embolization), type I and II endoleak in 2 patients, and sac growth without imaging evidence of endoleak in the other 10. After the infrarenal aorta was prepared (via a retroperitoneal access, whenever possible), the technique consisted of performing a banding of the neck with Teflon (DuPont, Wilmington, Del), a sacotomy to remove the thrombus or the hygroma, or both, and then suturing all of the feeding vessels that were found. Proximal and distal fenestrations were performed to avoid sac repressurization. The semiconversion was performed after a mean of 74 months after the initial EVAR. The mean aneurysm size at the time of the EVAR was 6.0 cm (range, 5.0-9.5 cm), and the mean aneurysm size at the time of the semiconversion was 7.7 cm (range, 5.5-11.5 cm). The overall aneurysm size increase was 38%, and the average growth rate was 8.2% per year. One patient had a stable aneurysm size but was treated because of an emergency condition. Technical success was 100%, with resolution of the endoleak and no perioperative deaths. Four cardiac deaths were registered at 12, 26, 30, and 60 months (mean follow-up, 42 months; range, 1-80 months). Graft salvage appears to be a valid option compared with open repair when considering treatment of persistent type II endoleak. This case series shows that semiconversion is a safe and effective treatment for otherwise untreatable type II endoleak.

Outcomes of EVAR with the endurant stent-graft system in patients with infrarenal ruptured abdominal aortic aneurysms: Is hostile anatomy a challenging factor?

PurposeTo compare outcomes of endovascular aneurysm repair (EVAR) using the Endurant-I stent-graft system between patients who have ruptured abdominal aortic aneurysms (rAAAs) with normal and hostile anatomy. Materials and methodsPatients with rAAAs who underwent EVAR between January 2008 and March 2014 were included in the study. There were 21 (70%) men and 9 (30%) women with a mean age of 70 years. Multidetector computed tomography (CT) angiography findings of the rAAA were classified according to the “Classification based on CT findings,” and imaging planning was performed according to the Society of Interventional Radiology Guideline. Primary outcome measures (POM) were procedure-related mortality, 30-day mortality, and survival rate at 1 year. Secondary outcome measures (SOM) were technical success, open surgical conversion, complications, survival, relationship between size-severity of the rAAA and mortality, procedure time, hospital stay. ResultsThe periprocedural-EVAR mortality rate was 33%. The overall mortality rate without prehospital phase deaths was 40.0%. Seventy three percent of the patients with rAAAs had hostile anatomy. There were no statistically significant differences between the groups in POMs and SOMs (except mean hospital stay). Mean hospital stay was shorter in the normal anatomy group. The mortality rate was higher in patients with hematoma in both sides of the aorta and free intraperitoneal hematoma. ConclusionEVAR of rAAAs with hostile anatomy is feasible and off-label use of Endurant-I endografts could be expanded.

Pfannenstiel incision for intact specimen extraction in laparoscopic transperitoneal radical nephrectomy: a longitudinal prospective outcome study

OBJECTIVES:To evaluate the intra- and postoperative outcomes of patients undergoing laparoscopic radical nephrectomy with intact specimen extraction through a Pfannenstiel transverse suprapubic incision.METHODS:Prospective follow-up of 26 laparoscopic transperitoneal radical nephrectomies for suspected renal tumors in which the kidneys were extracted via a Pfannenstiel lower abdominal transverse incision.RESULTS:The mean operating time was 152.3 (80–255) minutes, and the mean blood loss was 90 (20–300) ml. The mean extraction time was 20.4 (12–35) minutes. The mean weight of the removed specimen was 631.5 (190–1505) grams, and the mean longest diameter of the extracted specimen was 17.4 (9–25) cm. The mean extraction incision size was 10.7 (7–16) cm. No open surgical conversions were necessary. Pain control was excellent, with minimal intravenous morphine equivalent narcotic use by patients: 15.7 (0–31) mg in the recovery room, 33.8 (0–127) mg on the first postoperative day and 8.7 (0–60) mg in the first week after discharge. The patients experienced a short duration to full ambulation and normal dietary intake. Postoperative follow-up visits were recorded for at least six months. The patients reported a high cosmetic satisfaction rate of 97.7% (60–100). No late postoperative complications were observed related to the extraction site.CONCLUSIONS:The operative specimen can be extracted via a low transverse Pfannenstiel incision during radical laparoscopic nephrectomy. This incision ensures the extraction of large specimens while preserving the aesthetic and functional advantages of laparoscopy without increasing the cancer risk. The absence of muscle cutting maintains the integrity of the abdominal wall and elicits minimal pain. No postoperative incisional hernias or keloid formations were observed.

Rates of adverse events and correction procedures after elective versus emergent aortouni-iliac endografting during mid-term follow-up: A prospective cohort study

BackgroundDue to preferential implantation of bifurcated devices during endovascular repair of infrarenal abdominal aortic aneurysms (AAA), longer-term results following aortouni-iliac (AUI) endografting are scarce. The aim of this study was to determine the rate of endoleaks as well as frequency of secondary correction procedures after elective and emergent AUI endografting. MethodsA prospectively gathered database at a tertiary care university hospital was retrospectively reviewed from January 2000 until January 2012. This interrogation identified 61 patients who had undergone AUI endografting to treat their AAA. Data retrieval obtained 47 patients with elective AAA repairs while 14 patients received emergent AUI endografting in case of rupture. Procedural outcomes, endoleaks, complications, and secondary interventions during mid-term follow-up were recorded for analysis. ResultsFifty-five patients of the study cohort were male (90.2%) and mean age was 76.5 years (median: 77.2, Q1–Q3: 72.1–81.6). Patient demographics, comorbidities, procedural characteristics, as well as median follow-up length (39.8 months versus 34.9 months) were similar between groups. Endoleaks, complications, and rate of secondary correction procedures were not increased following emergent AUI endografting. The majority of these interventions comprised catheter-based or less invasive surgical procedures. All patients requiring major surgery (three open surgical conversions with endograft explantation and one open aortic banding) survived, while one patient sustained fatal myocardial infarction after a transluminal correction procedure. ConclusionEmergent AUI endografting was not associated with higher rates of adverse events or correction procedures during mid-term follow-up. Secondary interventions to maintain aneurysm exclusion could be carried out with low mortality.

Midterm Outcome of EndoAnchors for the Prevention of Endoleak and Stent-Graft Migration in Patients With Challenging Proximal Aortic Neck Anatomy

Purpose: To explore the use of EndoAnchors as an adjunct to endovascular abdominal aortic aneurysm repair for prevention of proximal neck complications in patients with challenging neck anatomy. Methods: Over a 28-month period, 208 patients (159 men; mean age 72±8 years) were enrolled in the ANCHOR prospective, multicenter registry (ClinicalTrials.gov; identifier NCT01534819) for prophylaxis against proximal neck complications. Patients were eligible when, in the opinion of the investigators, they were at increased risk for type Ia endoleak or migration owing to a hostile neck (length <10 mm, diameter >28 mm, angulation >60°, mural thrombus or calcium >2 mm in thickness or >180° in circumference, or conical shape). Overall, 123/157 (78.3%) patients met the criteria for a hostile neck according to core laboratory assessment of 157 adequate preoperative computed tomographic (CT) images. Results: Implantation of EndoAnchors was technically successful in 204/208 (98.1%) patients. The frequency of fracture was 0.3% (3/1118); there were no clinical sequelae associated with the fractures. Over the mean 14-month follow-up, 95.2% of patients were alive, and no deaths were attributable to EndoAnchors. There were no ruptures, migrations, or open surgical conversions. Aneurysm-related reinterventions were performed in 8 (3.8%) patients. Among 130 patients with postprocedure contrast CT studies, core laboratory analysis identified 2 (1.5%) patients with type Ia endoleaks. Aneurysm sac diameter decreased >5 mm in 42.9% of patients with CT scans at or beyond 1 year; 1.6% of patients developed sac enlargement >5 mm. Conclusion: Prophylactic EndoAnchor use for challenging aortic neck anatomy was associated with satisfactory midterm results.

Results of the ANCHOR prospective, multicenter registry of EndoAnchors for type Ia endoleaks and endograft migration in patients with challenging anatomy

Proximal attachment site complications continue to occur after endovascular repair of abdominal aortic aneurysms (EVAR), specifically type Ia endoleak and endograft migration. EndoAnchors (Aptus Endosystems, Sunnyvale, Calif) were designed to enhance endograft proximal fixation and sealing, and the current study was undertaken to evaluate the potential benefit of this treatment. During the 23-month period ending in December 2013, 319 subjects were enrolled at 43 sites in the United States and Europe. EndoAnchors were implanted in 242 patients (75.9%) at the time of an initial EVAR procedure (primary arm) and in 77 patients with an existing endograft and proximal aortic neck complications (revision arm). Technical success was defined as deployment of the desired number of EndoAnchors, adequate penetration of the vessel wall, and absence of EndoAnchor fracture. Procedural success was defined as technical success without a type Ia endoleak at completion angiography. Values are expressed as mean± standard deviation and interquartile range. The 238 male (74.6%) and 81 female (25.4%) subjects had a mean age of 74.1± 8.2years. Aneurysms averaged 58± 13 (51-63) mm in diameter at the time of EndoAnchor implantation (core laboratory measurements). The proximal aortic neck averaged 16± 13 (7-23) mm in length (42.7%<10mm and 42.7% conical) and 27± 4mm (25-30mm) in diameter; infrarenal neck angulation was 24± 15 (13-34) degrees. The number of EndoAnchors deployed was 5.8± 2.1 (4-7). Technical success was achieved in 303 patients (95.0%) and procedural success in 279 patients (87.5%), 217 of 240 (89.7%) and 62 of 77 (80.5%) in the primary and revision arms, respectively. There were 29 residual type Ia endoleaks (9.1%) at the end of the procedure. During mean follow-up of 9.3± 4.7months, 301 patients (94.4%) were free from secondary procedures. Among the 18 secondary procedures, eight were performed for residual type Ia endoleaks and the others were unrelated to EndoAnchors. There were no open surgical conversions, there were no aneurysm-related deaths, and no aneurysm ruptured during follow-up. Use of EndoAnchors to treat existing and acute type Ia endoleaks and endograft migration was successful in most cases. Prophylactic use of EndoAnchors in patients with hostile aortic neck anatomy appears promising, but definitive conclusions must await longer term follow-up data.

Seventeen Years’ Experience of Late Open Surgical Conversion after Failed Endovascular Abdominal Aortic Aneurysm Repair with 13 Variant Devices

To investigate the causes and results of late open surgical conversion (LOSC) after failed abdominal aortic aneurysm repair (EVAR) and to summarize our 17 years' experience with 13 various endografts. Retrospective data from August 1994 to January 2011 were analyzed at our center. The various devices' implant time, the types of devices, the rates and causes of LOSC, and the procedures and results of LOSC were analyzed and evaluated. A total of 1729 endovascular aneurysm repairs were performed in our single center (Nuremberg South Hospital) with 13 various devices within 17 years. The median follow-up period was 51 months (range 9-119 months). Among them, 77 patients with infrarenal abdominal aortic aneurysms received LOSC. The LOSC rate was 4.5 % (77 of 1729). The LOSC rates were significantly different before and after January 2002 (p < 0.001). The reasons of LOSC were mainly large type I endoleaks (n = 51) that were hard to repair by endovascular techniques. For the LOSC procedure, 71 cases were elective and 6 were emergent. The perioperative mortality was 5.2 % (4 of 77): 1 was elective (due to septic shock) and 3 were urgent (due to hemorrhagic shock). Large type I endoleaks were the main reasons for LOSC. The improvement of devices and operators' experience may decrease the LOSC rate. Urgent LOSC resulted in a high mortality rate, while selective LOSC was relatively safe with significantly lower mortality rate. Early intervention, full preparation, and timely LOSC are important for patients who require LOSC.

Clinical outcome of an extended proximal seal zone with the AFX endovascular aortic aneurysm system

Despite improvements in endograft technology, operator skill, and patient selection, endovascular aneurysm repair continues to be associated with device-related complications. A retrospective, observational study was undertaken to evaluate the clinical outcome and imaging findings of a unique device having externally-mounted, conformable graft material. Infrarenal abdominal aortic aneurysms were treated with the Endologix, Inc AFX endovascular aortic aneurysm system (Irvine, Calif) endograft in 108 consecutive patients over a 25-month period at two U.S. clinical sites. Baseline characteristics and procedural outcomes were reviewed by independent monitors. Serial computed tomography (CT) imaging assessments were performed by an independent core laboratory. Aortic neck characteristics and graft apposition were analyzed from center line-reformatted CT data sets in 37 patients in an imaging cohort comprising subjects with high-resolution baseline and follow-up CT imaging for precise assessment of aortic neck characteristics. The mean follow-up was 11± 5months overall, 9± 6months in patients with core laboratory imaging, and 5± 2months for patients in the imaging cohort. Among the 108 patients, 103 (95%) had intact aneurysms and five (4.6%) were treated for rupture; 80 (74%) were male and 28 (26%) were female. On average, 2.3± 0.7 endograft components were implanted per patient and no adjunctive proximal neck bare stents were used. There were no perioperative deaths in patients with intact aneurysms; two patients who presented with ruptured aortic aneurysms (40%) died. Major adverse events occurred within 30days of implantation in two patients (1.9%) with intact aneurysms. Type II endoleaks were evident on completion angiography in 18 patients (16.7%). Core laboratory analysis of CT studies identified two patients with type Ia endoleaks (2.3%), two with type III endoleaks (2.3%), and five with type II endoleaks (5.7%). Aneurysm-related secondary procedures were required in five patients over the first year of follow-up (4.6%). No patient developed endograft limb occlusion or aneurysm rupture and there were no open surgical conversions. In the imaging cohort, 360° graft-to-aortic wall apposition was continuous over a length of 25± 17mm and extended the seal zone an average of 5mm beyond the end of the anatomic neck. Early sac regression was correlated with neck length (P= .019) and graft-to-aortic apposition surface area (P= .039). The real-world use of the AFX endograft was associated with a low rate of device-and procedure-related complications. The ability to achieve an extended seal zone beyond the anatomical neck might in part contribute to positive outcomes, including the low type Ia and type II endoleak rate. These findings suggest that the AFX device might offer some advantages over other currently marketed endografts, but confirmation awaits the availability of longer-term outcome data.

Elective endovascular aortic repair conversion for type Ia endoleak is not associated with increased morbidity or mortality compared with primary juxtarenal aneurysm repair

Type Ia endoleak after endovascular aortic repair (EVAR) can be a challenging complication to manage, and due to concerns regarding morbidity and mortality of open surgical conversion (OSC), reports of complex endoluminal salvage techniques are increasing. Despite development of these endovascular remedial strategies, many patients ultimately require OSC. The purpose of this analysis was to outcomes of elective OSC for type Ia endoleak and compare them with elective primary open juxtarenal aneurysm repair (OJAR) to determine if these concerns are warranted. From 2000 to 2012, 54 patients underwent EVAR OSC at median time of 27 months (interquartile range, 9-55 months). Indications included endograft thrombosis in 2 (4%), intraoperative EVAR failure in 3 (6%), rupture in 5 (9%), graft infection in 6 (11%), and type Ia endoleak in 25 (all: 38 [70%]). Because many OSCs are performed for emergency indications without endovascular options, we chose elective type Ia endoleak patients as our study group. These 25 patients were compared with an elective OJAR cohort matched by anatomy and comorbidities. Primary end points were 30-day and 1-year mortality. Secondary end points included early complications, cross-clamp time, procedure time, blood loss, and length of stay. Demographic and comorbidity data in the OSC and OJAR groups did not differ, with the exception that OJAR patients presented with smaller aneurysm diameter and a higher rate of chronic obstructive pulmonary disease (P = .03). OSC patients more frequently underwent a nontube graft repair (OSC, n = 20 [80%] vs OJAR, n = 6 [24%]; P = .0002), required longer procedure times (P = .03), and received more plasma transfusions (P = .03). The 30-day mortality was 4% in both groups (observed difference in rates, 0%; 95% confidence interval for difference in mortality rates, -14.0% to 14.0%; P = 1). A similar rate of major complications occurred (OSC, n = 9 [36%] vs OJAR, n = 8 [32%]; P = 1). One-year survival was 83% in OSC and 91% in OJAR (observed difference, 7%; 95% confidence interval, -15% to 29%; P = .65). Despite many advances in EVAR technology, the need for OSC persists and will likely become more common as older-generation devices fail or providers attempt EVAR in more anatomically complex patients. Elective OSC for type Ia endoleak can be technically challenging but is not associated with increased morbidity or mortality compared with OJAR in appropriately selected patients. These results should be considered before pursuing complex endovascular remediation of EVAR failures.

EVAR Conversion for Type 1a Endoleak is not associated with Increased Morbidity or Mortality Compared with Primary Juxtarenal Aneurysm Repair

Objectives Type 1a endoleak after endovascular aortic repair (EVAR) can be a challenging complication to manage, and due to concerns regarding morbidity and mortality of open surgical conversion (OSC), reports of complex endoluminal salvage techniques are increasing. Despite development of these endovascular remedial strategies, many patients ultimately require OSC. The purpose of this analysis was to determine outcomes of elective open conversion for type 1a endoleak and compare them to elective primary open juxtarenal aortic repair (OJAR) to determine if these concerns are warranted.

Endovascular Treatment of Ruptured Abdominal Aortic Aneurysms: Is Now EVAR the First Choice of Treatment?

This study was designed to evaluate the effectiveness of endovascular treatment (EVAR) for ruptured abdominal aortic aneurysms (rAAAs). Between September 2005 and December 2012, 44 patients with rAAA suitable for endovascular repair underwent emergency EVAR. We did not consider hemodynamic instability to be a contraindication for EVAR. Successful stent-graft deployment was achieved in 42 patients, whereas 2 required open surgical conversion. The overall 30-day mortality was 10 of 44 patients (5/34 in stable patients, 5/10 in unstable patients). Postoperative complications were observed in 7 of 44 patients (16 %): 5 patients developed abdominal compartment syndrome requiring decompressive laparotomy; 1 patient developed bowel ischemia; 1 patient had limb ischemia, and 1 had hemodynamic shock. Mean length of intensive care unit stay was 2.9 (range 2–8) days, and mean length of hospital stay was 8.6 (range 0–18) days. At a mean follow-up of 22.2 (range 1–84) months, the overall incidence of endoleak was 23.5 %: 1 type I and 7 type II endoleaks. Our study demonstrates that EVAR of rAAA is associated with acceptable mortality and morbidity rates in dedicated centers.

Predictors of percutaneous access failure requiring open femoral surgical conversion during endovascular aortic aneurysm repair

To determine predictors of percutaneous (PEVAR) access failure requiring conversion to an open approach (OEVAR) during endovascular aortic aneurysm repair (EVAR). A single-center retrospective review of all EVAR patients from January 2009 through June 2011 with multivariate analysis of clinical and anatomic variables that could impact access outcome was conducted. Target vessel calcification was categorized as mild, moderate, or severe based on circumferential calcium arc (<⅓, ⅓ to ½, and >½ respectively), dyslipidemia (defined as low-density lipoprotein >130 mg/dL or receiving lipid lowering medication), and obesity (defined as body mass index [BMI] >30). We investigated 400 access sites for 200 patients who underwent EVAR. The study cohort's characteristics included an average age of 72.8 ± 9.0 years, vessel size of 9.6 ± 1.8 mm, sheath size of 17.1 ± 3.0 Fr, BMI of 27.6 ± 5.3, and estimated glomular filtration rate of 68.5 ± 24.2 mL/min. Comorbidities included dyslipidemia in 129 patients (64.5%) and diabetes in 54 patients (27%). There were 132 OEVAR (66 patients), two mixed OEVAR with contralateral PEVAR (one patient), and 266 (133 patients) PEVAR approaches. Use of PEVAR increased over time (45.5% [2009], 77.8% [2010], and up to 88.5% [2011]; P = .001) while conversions decreased (24.3% [2009], 8.7% [2010], and 4.3% [2011]; P = .001]. More OEVAR patients (35.8%) stayed longer than 3 days compared with 21.1% for PEVAR (P = .028). For the 266 PEVAR approaches, 32 access sites (12.0%) had to be converted. Severely calcified arteries were most predictive of conversion (odds ratio [OR], 36.4; P < .001). Year of procedure (2010; OR, 0.17; P = .001; 2011, OR, 0.20; P = .049), female gender (OR, 3.1; P = .017), moderately calcified arteries (OR, 2.5; P = .085), and age (OR, 2.3 [per decade]; P = .002) were all also significant. Vessel size, sheath size, and BMI were found to be nonsignificant predictors of conversion. PEVAR was found to be safe, reliable, and feasible. Several factors, including learning curve, vessel calcification, age, and female gender predicted conversion of PEVAR to OEVAR.

Stent graft-induced new entry tear after endoluminal grafting for aortic dissection repaired with open interposition graft

Thoracic endovascular aortic repair is a successful treatment strategy for type B aortic dissections, with low morbidity and mortality compared with the gold standard of open repair. Questions still remain regarding its long-term durability and complication rate. There is a growing awareness of new entry tears induced by the stent graft, a potentially lethal complication. We report the case of a 74-year-old woman with a complicated retrograde type A aortic dissection treated with endovascular stent graft coverage. She required open surgical conversion after she developed a symptomatic, new entry tear induced by the stent graft.