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PURPOSE: The purpose was to investigate outcomes of high-risk patients undergoing thoracoabdominal aortic aneurysm (TAAA) repair using fenestrated or branched endovascular aneurysm repair (F/BEVAR) devices at a single center in Canada. MATERIALS AND METHODS: A retrospective review of all patients undergoing endovascular TAAA repair with F/BEVAR from June 2007 to July 2020. Imaging and clinical endpoints of interest including death, reintervention, and target vessel patency were reported. RESULTS: Ninety-five consecutive patients underwent endovascular TAAA repair using F/BEVAR stent grafts (63 males, median age 74 [interquartile range 70, 78] years). Repairs included 81 elective and 14 urgent/emergent cases (6 ruptures and 8 symptomatic). Graft deployment was 100% successful. Intraoperative target vessel revascularization was successful in 336/355 (94.6%) vessels with the celiac having the lowest success rate 72/82 (87.8%). In-hospital mortality was 9.5% (7.4% elective and 21.4% urgent/emergent, p=0.125) and permanent paraplegia was 4.2% (3.7% elective and 7.1% urgent/emergent, p=0.458). In-hospital complications included stroke in 5.3%, acute myocardial infarction in 8.4%, and bowel ischemia in 5.3%. No patients required permanent dialysis or tracheostomy during their hospital stay. However, 22 (23.2%) patients required additional unplanned procedures for various indications (branch occlusion, endoleaks, realignment) during their hospital stay. Patients were followed up for a mean of 3.6 ± 3.0 years. Clinical follow-up was 100%, with 80/86 (93%) having surveillance imaging. On follow-up imaging, 43 (50%) patients had at least 1 endoleak identified and 337/341 (98.8%) of the target vessels were found to be patent. At 5 years, cumulative probability of reintervention was 46.3% (95% confidence interval [CI], 36.1-56.4). Survival at 5 and 8 years was 50.1% (95% CI, 38.4-65.4) and 34.4% (95% CI, 22.5-52.8), respectively. Progression of aneurysmal disease leading to rupture on follow-up was confirmed in 1 patient at 10 years. CONCLUSION: Endovascular TAAA repair provides a safe treatment option with a high technical success rate and low pulmonary and renal complications. Long-term survival is similar to previous literature; however, high rates of secondary reintervention reaffirm the need for ongoing patient follow-up and further technical improvements. CLINICAL IMPACT: This study demonstrates that endovascular repair of TAAAs can be performed in a high-risk elderly population with acceptable rates of mortality, TALE and SCI, using evolving technology. The incidences of post-operative respiratory failure and renal dysfunction were lower in patients who underwent endovascular repair compared with open repair. Future technical and procedural refinements in addition to increasing surgical experience are expected to lead to further improvements in short- and long-term outcomes exceeding those of open repair.
RESUMO
PURPOSE: Angio-Seal (Terumo Medical Corporations, Somerset, New Jersey) device is indicated for femoral arteriotomy closure. Real-world published data on complications are limited. We present 1 year of safety events involving Angio-Seal from the US Food and Drug Administration's post-market surveillance database of Manufacturer and User Facility Device Experience (MAUDE). Steps for managing frequent device-related problems are discussed. MATERIALS AND METHODS: Angio-Seal MAUDE data from November 2019 to December 2020 was classified according to (1) mode of device failure, (2) complication, (3) treatment, and (4) Cardiovascular and Interventional Radiological Society of Europe (CIRSE) adverse event classification system. RESULTS: There were 715 safety events, involving Angio-Seal VIP (93.1%), Evolution (5.7%), STS Plus (1.1%), and sizes 6F (62.5%) and 8F (37.5%). Failure mode involved unrecognized use of a damaged device (43.4%), failed deployment (20.1%), failed arterial advancement (6.3%), detachment of device component (4.9%), failed retraction (3.6%), operator error (1.1%), and indeterminate (20.6%). Of total, 44.8% of events were associated with patient harm. Complications involved minor blood loss (34.1%), hematoma (5.6%), significant blood loss (1.4%), and pseudoaneurysm (1.4%). Of total, 43.3% of cases required manual compression (MC), whereas 8.8% required more advanced intervention. Interventions included surgical repair (49.2%), thrombin injection (9.5%), balloon tamponade (6.3%), covered stent (4.8%), and unspecified (30.2%). Majority of safety events were CIRSE grade 1 (92.0%), followed by grades 2 (3.1%), 3 (4.6%), and 6 (deaths, 0.3%). Minority of devices were returned for manufacturer analysis (27.8%). CONCLUSIONS: The majority of safety events were associated with minor blood loss or local hematoma and could be addressed with MC alone. Most events were attributed to damaged device; however, very few devices were returned to manufacturer for analysis. This should be encouraged to allow for root cause analysis in order to improve safety profile of devices. System-level strategies for addressing barriers to under-reporting of safety events may also be considered. CLINICAL IMPACT: Our study highlights important safety events encountered in real-world practice with Angio-Seal closure device. The MAUDE database captures real-world device malfunctions not typically appreciated in conventional clinical trials. Our study provides valuable insight for clinician-users on anticipating and managing the most common device malfunctions. Additionally, our data provide feedback for manufactures to optimize product design and direct manufacturer user training to improve safety. Finally, we hope that the study promotes system-level strategies that foster reporting of safety events and undertaking of root cause analysis.
RESUMO
This brief report describes a hybrid endovascular and open procedure to treat internal iliac artery (IIA) aneurysms and preserve pelvic blood flow. A covered stent was deployed before surgery in the superior gluteal artery, extending across the IIA aneurysm, with the proximal end in the common iliac artery lumen. During open aortoiliac aneurysm repair, the stent graft was anastomosed in an end-to-side manner to the surgical graft. Four aneurysms were treated in 3 patients. Technical success was achieved in all cases. There were no complications or repeat interventions. Stents were all patent at imaging follow-up (range, 6-25 mo). Patients were free from buttock claudication.
