Synopsis: This is an international multicenter study that looks at the safety and efficacy of physician-modified endografts (PMEGs) used for thoracic and abdominal aortic aneurysms. Overall, the authors found this technique to be safe and effective for elective, symptomatic, and ruptured aortic aneurysms.
Summary: Since Chuter et al reported the first endovascular repair of a thoracoabdominal aortic aneurysm (TAAA) in 2001, physician-modified endografts (PMEGs) have emerged as a vital treatment option for patients with complex abdominal aortic aneurysms (CAAA) and TAAA who are too high-risk for open surgical repair. While fenestrated and branched custom-made devices (CMD, aka “IDE BEVAR/FEVAR”) remain the gold standard, their limited availability and manufacturing times have led to alternative strategies (parallel grafts, commercial off-the-shelf grafts, PMEGs). Among these options, a well-planned and constructed PMEGs most closely approximate custom devices (CMD) but require significant technical expertise. This study aimed to evaluate the real-world safety and effectiveness of PMEGs in treating TAAAs and CAAAs.
An international multicenter retrospective cohort study including 19 centers (9 USA, 9 Europe, 1 Asia) examined 1,274 consecutive patients from 2007-2022 who received PMEGs for complex aortic aneurysms, which included CAAA (45% of patients; short neck, juxtarenal, pararenal and suprarenal) or TAAA (65% of patients; Extent I-V). Patients were predominantly male (75%) with a median age of 74 years. Most cases were elective (65%), while 25% were performed for symptomatic aneurysms and 10% performed for ruptured aneurysms. The study excluded patients undergoing endovascular aortic arch repairs, iliac modifications, open/hybrid procedures, or any in situ techniques.
Operatively, the majority of PMEG procedures created fenestrated grafts (83% FEVAR), with fewer using branched (3.6% BEVAR) or combination of both (13.4% F/B-EVAR) to preserve visceral arteries. Thirty-day mortality was 5.8% overall but varied by presentation. Major adverse events (MAEs), which was a composite of all-cause mortality, myocardial infarction, stroke, paraplegia, bowel ischemia, respiratory failure, and renal insufficiency occurred in 25% of patients overall. This increased with case urgency - from 23% in elective cases to 28% in symptomatic and 30% in ruptured cases. Higher MAE rates were associated with TAAA (vs CAAA), an urgent procedure, ASA score ≥3, longer operation time, or a technical failure. Encouragingly, complication rates improved from 33% before 2013 to 22% after, suggesting a learning curve and/or better patient selection. Post-2013 cases also showed improved operative times, less blood loss, but an increased PMEG use in emergency cases, though overall outcomes remained similar.
After a median follow-up of 21 months, the 5-year outcomes showed that half of patients needed reintervention (51%: elective 50%, symptomatic 57%, rupture 41.7%), though vessel patency remained excellent at 90%. Overall survival was 55%, with similar rates across all groups (elective 56%, symptomatic 56%, ruptured 49%). Importantly, freedom from aortic-related death was high at 89%. These rates declined gradually from 1-year outcomes of 74%, 97%, 82%, and 93% respectively. While reintervention rates were significant, they matched those of custom-made devices and typically involved minor procedures that did not affect survival. Additionally, while overall survival is low, these were predominantly non-aortic driven (143 cases where cause was known: 25% cardiovascular, 20% cancer, 15% infection, 14% respiratory).
This study had several key limitations: its retrospective design, results coming only from experienced high-volume centers, lack of comparison with other treatments, and incomplete data on surgical techniques. Additionally, the cause of death was unknown in nearly 60% of non-aortic deaths.
Bottom Line: PMEGs appear to be a safe and effective treatment option for complex aortic aneurysms when performed in experienced centers. While patients require lifetime surveillance and should be prepared for possible reinterventions, the technique offers a viable alternative to the gold standard custom-made devices, particularly in urgent cases or when custom devices are unavailable.