Endovascular Repair With Fenestrated-Branched Stent Grafts Improves 30-Day Outcomes for Complex Aortic Aneurysms Compared With Open Repair (original) (raw)
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Journal of vascular surgery, 2014
The benefit of fenestrated endovascular aortic aneurysm repair (FEVAR) compared with open surgical repair (OSR) of complex abdominal aortic aneurysms (CAAAs) is unknown. This study compares 30-day outcomes of these procedures from two high-volume centers where FEVAR was undertaken for high-risk patients. Patients undergoing FEVAR with commercially available devices and OSR of CAAAs (total suprarenal/supravisceral clamp position) were propensity matched by demographic, clinical, and anatomic criteria to identify similar patient cohorts. Perioperative outcomes were evaluated using univariate and multivariate methods. From July 2001 to August 2012, 59 FEVAR and 324 OSR patients were identified. After 1:4 propensity matching for age, gender, hypertension, congestive heart failure, coronary disease, chronic obstructive pulmonary disease, stroke, diabetes, preoperative creatinine, and anticipated/actual aortic clamp site, the study cohort consisted of 42 FEVARs and 147 OSRs. The most freq...
Journal of Vascular Surgery, 2016
Background: More than 80% of infrarenal aortic aneurysms are treated by endovascular repair. However, adoption of fenestrated and branched endovascular repair for complex aortic aneurysms has been limited, despite high morbidity and mortality associated with open repair. There are few published reports of consecutive outcomes, inclusive of all fenestrated and branched endovascular repairs, starting from the inception of a complex aortic aneurysm program. Therefore, we examined a single center's consecutive experience of fenestrated and branched endovascular repair of complex aortic aneurysms. Methods: This is a single-center, prospective, observational cohort study evaluating 30-day and 1-year outcomes in all consecutive patients who underwent fenestrated and branched endovascular repair of complex aortic aneurysms (definition: requiring one or more fenestrations or branches). Data were collected prospectively through an Institutional Review Board-approved registry and a physician-sponsored investigational device exemption clinical trial (G130210). Results: We performed 100 consecutive complex endovascular aortic aneurysm repairs (November 2010 to March 2016) using 58 (58%) commercially manufactured custom-made devices and 42 (42%) physician-modified devices to treat 4 (4%) common iliac, 42 (42%) juxtarenal, 18 (18%) pararenal, and 36 (36%) thoracoabdominal aneurysms (type I, n ¼ 1; type II, n ¼ 4; type III, n ¼ 12; type IV, n ¼ 18; arch, n ¼ 1). The repairs included 309 fenestrations, branches, and scallops (average of 3.1 branch arteries/case). All patients had 30-day follow-up for 30-day event rates: three (3%) deaths; six (6%) target artery occlusions; five (5%) progressions to dialysis; eight (8%) access complications; one (1%) paraparesis; one (1%) bowel ischemia; and no instances of myocardial infarction, paralysis, or stroke. Of 10 type I or type III endoleaks, 8 resolved (7 with secondary intervention, 1 without intervention). Mean follow-up time was 563 days (interquartile range, 156-862), with three (3%) patients lost to follow-up. On 1-year Kaplan-Meier analysis, survival was 87%, freedom from type I or type III endoleak was 97%, target vessel patency was 92%, and freedom from aortic rupture was 100%. Average lengths of intensive care unit stay and inpatient stay were 1.4 days (standard deviation, 3.3) and 3.6 days (standard deviation, 3.6), respectively. Conclusions: These results show that complex aortic aneurysms can now be treated with minimally invasive fenestrated and branched endovascular repair. Endovascular technologies will likely continue to play an increasingly important role in the management of patients with complex aortic aneurysm disease.
Journal of Vascular Surgery, 2019
Objective: Physician-modified fenestrated stent grafts (PMSGs) are a useful option for urgent or semiurgent treatment of complex abdominal aortic aneurysms (CAAAs). The aim of this study was to describe in-hospital outcomes of custommade fenestrated stent grafts (CMSGs) and PMSGs for the treatment of CAAAs and thoracoabdominal aortic aneurysms (TAAAs). Methods: In this single-center, retrospective study, all consecutives patients with CAAAs or TAAAs undergoing endovascular repair using Zenith CMSGs (Cook Medical, Bloomington, Ind) or PMSGs between January 2012 and November 2017 were included. End points were intraoperative adverse events, in-hospital mortality, postoperative complications, reinterventions, target vessel patency, and endoleaks. Results: Ninety-seven patients were included (CMSGs, n ¼ 69; PMSGs, n ¼ 28). The PMSG group included more patients assigned to American Society of Anesthesiologists class 4 (n ¼ 14 [50%] vs n ¼ 16 [23%]; P ¼ .006) and more TAAAs (n ¼ 17 [61%] vs n ¼ 10 [15%]; P < .0001). Intraoperative adverse events were recorded in eight (11%) patients in the CMSG group vs six (21%) patients in the PMSG group. No intraoperative death or open conversion occurred. In-hospital mortality rates were of 4% (n ¼ 3) in the CMSG group and 14% in the PMSG group (n ¼ 4). Chronic renal failure was an independent preoperative risk factor of postoperative death or complications (odds ratio, 4.88; 95% confidence interval, 1.65-14.43; P ¼ .004). Rates of postoperative complications were 22% (n ¼ 15) and 25% (n ¼ 7) in the CMSG and PMSG groups. Spinal cord ischemia rates were 4% (n ¼ 3) and 7% (n ¼ 2) in the CMSG and PMSG groups. Reintervention rates were 16% (n ¼ 11) in the CMSG group and 32% (n ¼ 9) in the PMSG group. At discharge, target vessel patency rate in CMSGs was 98% (n ¼ 207/210). All target vessels (n ¼ 98) were patent in the PMSG group. Endoleaks at discharge were observed in 24% of the CMSG group (n ¼ 16) vs 8% of the PMSG group (n ¼ 2). Conclusions: Our study showed clinically relevant differences of several important in-hospital outcomes in the CMSG and PMSG groups. Larger cohorts and longer follow-up are needed to allow direct comparison. PMSGs may offer acceptable in-hospital results in patients requiring urgent interventions when CMSGs are not available or possible.
Endovascular repair of complex aortic aneurysms
The Israel Medical Association journal : IMAJ, 2014
BACKGROUND Surgery for complex aortic aneurysms (thoracoabdominal, juxtarenal and pseudoaneurysms) is associated with a high morbidity and mortality rate. Branched and fenestrated stent grafts constitute a new technology intended as an alternative treatment for this disease. OBJECTIVES To describe a single-center experience with fenestrated and branched endografts for the treatment of complex aortic aneurysms. METHODS We reviewed all cases of complex aortic aneurysms treated with branched or fenestrated devices in our center. Data collected included device specifics, perioperative morbidity and mortality, re-intervention rates and mid-term results. RESULTS Between 2007 and 2012 nine patients were treated with branched and fenestrated stent grafts. Mean age was 73 years. Mean aneurysm size was 63 mm. Perioperative mortality was 22% (2/9). During the follow-up, re-interventions were required in 3 patients (33%). Of 34 visceral artery branches 33 remained patent, resulting in a patency...
Journal of Endovascular Therapy, 2006
This review concluded that fenestrated endovascular stent-grafts for abdominal aortic aneurysms are a feasible alternative to open surgery. Several methodological problems within the review indicate that the conclusions should be treated with caution. Conclusions on the relative benefits of the technique to open surgery were not based on the evidence presented and would need to be confirmed in direct comparisons. Authors' objectives To review the use of fenestrated endovascular grafts in patients with abdominal aortic aneurysms (AAAs) focusing on short-to mid-term outcomes. Searching MEDLINE was searched for research published in the English language; the keywords were listed in the report. The search dates were limited to 1999 to 2006 as the use of the technology was first reported in 1999. The reference lists of identified articles were checked for additional articles of relevance. Study selection Study designs of evaluations included in the review Both prospective and retrospective studies of at least 10 patients were included. Conference abstracts, technical or case reports, or review articles were excluded. Specific interventions included in the review Studies needed to investigate AAA repair with a fenestrated stent-graft and report the number of vessels fenestrated and their status (perfusion, stenosis or occlusion) after the procedure. The Zenith stent-graft was the only device included in the review. Follow-up periods ranged from 0 to 48 months, with a greater than 12-month mean follow-up reported in 4 studies. Participants included in the review Studies of patients with thoracic or abdominal or thoracoabdominal aneurysms were eligible for inclusion in the review. Eighty-two per cent (95% confidence interval, CI: 75, 84) of the patients were male. Outcomes assessed in the review To be eligible, studies needed to report peri-procedural and post-procedural outcomes. The outcomes included in the review were mortality (before and after 30 days), perfusion of fenestrated arteries, renal dysfunction, occluded arteries, stenosed arteries and endoleaks before or after 30 days. How were decisions on the relevance of primary studies made? The authors did not state how the papers were assessed for relevance, or how many reviewers performed the assessment. Assessment of study quality The authors did not assess validity. Data extraction Two reviewers individually extracted the data. Methods of synthesis How were the studies combined?
Annals of Vascular Surgery, 2017
To present our early experience and highlight the technical difficulties associated with the use of fenestrated and branched stentgrafts to treat patients with juxta-, para-renal abdominal aortic aneurysms (AAA) and thoracoabdominal aortic aneurysms (TAAA). Methods: A prospectively held database maintained at our department, was queried for patients who have undergone branched and fenestrated stent-grafting for AAA or TAAA treatment. Indication for repair, comorbidity precluding open repair, technical challenges associated with the repair, as well as operative mortality, morbidity and re-intervention rate were evaluated. Results: A total of eight patients underwent repair with a fenestrated or branched stent-graft. All patients had aneurysmal degeneration of the juxta-, para-renal aorta and thoracoabdominal aorta not suitable to standard endovascular techniques. Two patients had a prior aortic repair, a failed migrated stent-graft and an old surgical tube graft after an open repair. One patient had a type III TAAA and one patient had a postdissection TAAA type I. For all patients, target vessel success rate was 96.4% (27/28) and mean hospital stay 6.0 days (range 3-21 days). Thirtyday and one-year mortality were 0%. Mean follow up was 23 months
Journal of Vascular Surgery, 2014
Objective: A recent prospective study found that fenestrated endovascular abdominal aortic aneurysm (AAA) repair (FEVAR) was safe and effective in appropriately selected patients at experienced centers. As this new technology is disseminated to the community, it will be important to understand how this technology compares with standard endovascular AAA repair (EVAR). The goal of this study was to compare the outcomes of FEVAR vs EVAR of AAAs. Methods: The American College of Surgeons-National Surgical Quality Improvement Program database from 2005 to 2012 was queried for AAAs (International Classification of Diseases, Ninth Revision code 441.4). Patients were stratified according to procedure (FEVAR vs EVAR). A bivariate analysis was done to assess preoperative and intraoperative risk factors for postoperative outcomes. Thirty-day postoperative mortality and complication rates were described for each procedure type. Multivariable logistic regression was performed to assess the association between the type of procedure and the risk of postoperative complications. Results: A total of 458 patients underwent FEVAR and 19,060 patients underwent EVAR for AAA. Patients undergoing FEVAR were older (P [ .02) and less likely to have a bleeding disorder (P [ .046). Otherwise, the incidence of comorbidities in both groups was similar. FEVAR was associated with increased median operative time (156 vs 137 minutes; P < .001), and average postoperative length of stay (3.3 vs 2.8 days; P [ .03). There was a statistically significant increase in overall complications (23.6% vs 14.3%; P < .001) and postoperative transfusions (15.3% vs 6.1%, P < .001) and trends toward increased cardiac complications (2.2% vs 1.3%; P [ .09) and the need for dialysis (1.5% vs 0.8%; P [ .08) in the FEVAR group. Mortality (2.4% vs 1.5%; P [ .12) was not statistically different. On multivariable analysis, FEVAR remained independently associated with the need for postoperative transfusions when operative time was <75th percentile (adjusted odds ratio, 1.72; 95% confidence interval, 1.09-2.72; P [ .02) as well as when operative time was >75th percentile for respective procedures (adjusted odds ratio, 5.33; 95% confidence interval, 3.55-8.00; P < .001). Conclusions: Patients undergoing FEVAR are more likely than patients undergoing EVAR to receive blood transfusions postoperatively and are more likely to sustain postoperative complications. Although mortality was similar, trends toward increased cardiac and renal complications may suggest the need for judicious dissemination of this new technology. Future research with larger number of FEVAR cases will be necessary to determine if these associations remain.
Vascular medicine (London, England), 2016
The introduction of fenestrated stent grafts (SGs) to treat abdominal aortic aneurysms (AAAs) with short proximal necks began in 1999. Nowadays, the whole visceral aorta can be treated totally by endovascular means. The established use of fenestrated devices to treat complex AAAs as a first-line management option has been previously reported. An up-to-date evaluation of the literature was performed including all types of publications regarding the use of fenestrated technology to repair complex AAAs. Fenestrated repair is now an established alternative to hybrid/chimney/snorkel repairs. However, specific criteria and prerequisites are required for the use and improvement of this method. Multiple device morphologies have been used incorporating the visceral arteries in various combinations. This modular strategy connects different devices (bridging covered stents and bifurcated SGs) with the aortic main body, thus excluding the aneurysm from the circulation. Precise deployment of the...
Postoperative Outcomes of Complex Aortic Aneurysm Repair Using Hybrid Open-Endovascular Techniques
Journal of Vascular and Endovascular Surgery, 2018
Aortic disease becomes more prevalent with age and can result in acute aortic conditions including aneurysm, dissection, intramural hematoma and penetrating ulcers. Repair techniques for these conditions remain controversial due to the varying outcomes of studies. This retrospective study collected and analyzed data from twenty-three (23) patients with complex aortic aneurysms repaired using hybrid open-endovascular techniques. A high percentage of patients (82.6%) suffered from multiple comorbidities, including hypertension, hyperlipidemia, renal disease, coronary artery disease, congestive heart failure and prior aortic procedures. All patients presented with ASA scores 3 or 4. Eleven patients (47.8%) presented with aneurysms of the ascending, transverse and descending arch, and seven patients (30.4%) with thoracoabdominal aneurysm. 78.3% of patients underwent thoracic vessel debranching, while the remainder underwent visceral vessel debranching (13.0%) or thoracic and visceral debranching (8.7%). No patients suffered visceral ischemia, spinal cord injury, extremity amputation or reoperation for bleeding post-operatively. Two patients suffered minor stroke (8.7%) and one patient (4.3%) had major stroke. Three patients (13.0%) suffered temporary kidney injury and one patient (4.3%) developed renal failure requiring dialysis. Four patients (17.4%) developed Type II stent graft endoleaks. All patients had patent grafts. Reintervention occurred in two patients (8.7%). Thirty-day mortality occurred in three patients (13.0%). These results are within the range reported in other studies involving hybrid repair of aortic conditions, and show that hybrid open-endovascular repair is a feasible alternative in high-risk patients.