George S Georgiadis1, Joost A van Herwaarden2, George A Antoniou3, Constantijn E V B Hazenberg2, Athanasios D Giannoukas4, Miltos K Lazarides5, Frans L Moll2. 1. Department of Vascular Surgery, University Medical Center Utrecht, the Netherlands Department of Vascular Surgery, "Democritus" University of Thrace, University General Hospital of Alexandroupolis, Greece ggeorgia@med.duth.gr. 2. Department of Vascular Surgery, University Medical Center Utrecht, the Netherlands. 3. Liverpool Vascular and Endovascular Service, Royal Liverpool University Hospital, Liverpool, UK. 4. Department of Vascular Surgery, University of Thessaly, Greece. 5. Department of Vascular Surgery, "Democritus" University of Thrace, University General Hospital of Alexandroupolis, Greece.
Abstract
PURPOSE: To determine the safety and efficacy of off-the-shelf fenestrated/branched grafts (OSFGs) and physician-modified stent-grafts (PMSGs) for the treatment of complex abdominal aortic aneurysms. METHODS: A systematic search of the MEDLINE database via PubMed from January 2001 through March 2015 retrieved 23 relevant articles evaluating the clinical outcomes following the management of patients with pararenal or thoracoabdominal aortic aneurysms. The 15 articles on PMSGs and 8 on OSFGs contained data on 308 patients (mean age 72.93±2.89 years; 213 men). The safety endpoint was major adverse events; the efficacy outcome measure was clinical treatment success (aneurysm exclusion without type I/III endoleak, permanent paralysis, long-term dialysis, or unresolved major complications). Extracted outcome data were pooled and compared between groups; data are given as the pooled proportions and 95% confidence interval (CI). Clinical data are presented as the weighted mean. RESULTS: Of the 308 patients analyzed, almost one third were operated on an emergency basis. The mean aneurysm diameters were 75.9±17.3 mm (range 56-115) for the PMSGs and 68.1±13.7 mm (range 60-100) for the OSFGs. A total of 936 renal and visceral vessels were targeted. Major adverse events (safety) occurred in 24 (12.8%) PMSG patients (95% CI 8.6% to 18.7%) and in 9 (7.4%) OSFG patients (95% CI 3.7% to 14%). Clinical treatment success (efficacy) was observed in 171/187 (91.4%) PMSG patients (95% CI 86.2% to 94.9%) and in 115/121 (95%) OSFG patients (95% CI 89.1% to 98.0%). Corresponding cumulative 30-day target vessel and branch stent perfusion rates were 97.2% (95% CI 95.1% to 98.4%) and 97.6% (95% CI 95.5% to 98.8%) for the PMSG group and 99.6% (95% CI 98.3% to 99.9%) and 98.4% (95% CI 96.5% to 99.4%) for the OSFG group. Six (3.2%) deaths occurred in the PMSG group only; 2 (1.1%) were aneurysm related. Overall branch patency was recorded in 443/458 (96.7%) and in 468/478 (97.9%) of target vessels in the PMSG and OSFG groups, respectively. CONCLUSION: Off-the-shelf and physician-modified technology seems effective and safe, in both the elective and acute settings, for the treatment of complex aortic aneurysms. Future research within a randomized trial should investigate the true limitations of these devices.
PURPOSE: To determine the safety and efficacy of off-the-shelf fenestrated/branched grafts (OSFGs) and physician-modified stent-grafts (PMSGs) for the treatment of complex abdominal aortic aneurysms. METHODS: A systematic search of the MEDLINE database via PubMed from January 2001 through March 2015 retrieved 23 relevant articles evaluating the clinical outcomes following the management of patients with pararenal or thoracoabdominal aortic aneurysms. The 15 articles on PMSGs and 8 on OSFGs contained data on 308 patients (mean age 72.93±2.89 years; 213 men). The safety endpoint was major adverse events; the efficacy outcome measure was clinical treatment success (aneurysm exclusion without type I/III endoleak, permanent paralysis, long-term dialysis, or unresolved major complications). Extracted outcome data were pooled and compared between groups; data are given as the pooled proportions and 95% confidence interval (CI). Clinical data are presented as the weighted mean. RESULTS: Of the 308 patients analyzed, almost one third were operated on an emergency basis. The mean aneurysm diameters were 75.9±17.3 mm (range 56-115) for the PMSGs and 68.1±13.7 mm (range 60-100) for the OSFGs. A total of 936 renal and visceral vessels were targeted. Major adverse events (safety) occurred in 24 (12.8%) PMSGpatients (95% CI 8.6% to 18.7%) and in 9 (7.4%) OSFGpatients (95% CI 3.7% to 14%). Clinical treatment success (efficacy) was observed in 171/187 (91.4%) PMSGpatients (95% CI 86.2% to 94.9%) and in 115/121 (95%) OSFGpatients (95% CI 89.1% to 98.0%). Corresponding cumulative 30-day target vessel and branch stent perfusion rates were 97.2% (95% CI 95.1% to 98.4%) and 97.6% (95% CI 95.5% to 98.8%) for the PMSG group and 99.6% (95% CI 98.3% to 99.9%) and 98.4% (95% CI 96.5% to 99.4%) for the OSFG group. Six (3.2%) deaths occurred in the PMSG group only; 2 (1.1%) were aneurysm related. Overall branch patency was recorded in 443/458 (96.7%) and in 468/478 (97.9%) of target vessels in the PMSG and OSFG groups, respectively. CONCLUSION: Off-the-shelf and physician-modified technology seems effective and safe, in both the elective and acute settings, for the treatment of complex aortic aneurysms. Future research within a randomized trial should investigate the true limitations of these devices.
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