Systematic Review of Off-the-Shelf or Physician-Modified Fenestrated and Branched Endografts.
OBJECTIVE
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.


CONCLUSIONS
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.
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.
George S
GS
Georgiadis
Department of Vascular Surgery, University Medical Center Utrecht, the Netherlands.
Joost A
JA
van Herwaarden
Liverpool Vascular and Endovascular Service, Royal Liverpool University Hospital, Liverpool, UK.
George A
GA
Antoniou
Department of Vascular Surgery, University Medical Center Utrecht, the Netherlands.
Constantijn E V B
CE
Hazenberg
Department of Vascular Surgery, University of Thessaly, Greece.
Athanasios D
AD
Giannoukas
Department of Vascular Surgery, "Democritus" University of Thrace, University General Hospital of Alexandroupolis, Greece.
Miltos K
MK
Lazarides
Department of Vascular Surgery, University Medical Center Utrecht, the Netherlands.
Frans L
FL
Moll
D000368:Aged; D000369:Aged, 80 and over; D017544:Aortic Aneurysm, Abdominal / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000209:etiology; D011474:Prosthesis Design; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency
branched stent-graft; fenestrated stent-graft; juxtarenal aortic aneurysm; off-the-shelf; pararenal aortic aneurysm; physician-modified stent-graft; stent-graft; suprarenal aortic aneurysm; surgeon-modified stent-graft; thoracoabdominal aortic aneurysm