Researchers have reported a 94% technical success rate and other key findings from a recent international, multicenter, single-arm cohort study of physician-modified endografts (PMEGs) for the repair of thoracoabdominal and complex abdominal aortic aneurysms (AAA). The work was published in the Journal of the American Heart Association (AHA). Traffic.
Nikolaos Tsilimparis (Maximilian University Hospital Munich, Germany) and colleagues point out in their introduction that despite the widespread use of PMEGs in thoracoabdominal and complex AAAs, “robust” data on their safety and efficacy in these pathologies are lacking. In general, they write, previous data are “limited to small, single-center studies.”
The aim of the researchers was therefore to conduct an international, multicenter study analyzing the results of PMEGs in elective, symptomatic and ruptured thoracoabdominal and complex AAAs.
In their research article et al State in detail that they defined variables and outcomes according to the Society for Vascular Surgery reporting standards and collected and analyzed device modifications and procedural details to support their analysis.
Regarding the results, the authors report that efficacy was measured by technical success and safety was measured by serious adverse events and 30-day mortality. In addition, the researchers examined follow-up outcomes, including reinterventions, endoleaks, target vessel patency rates, and overall and aortic-related mortality. They performed a multivariable analysis to identify predictors of technical success, 30-day mortality, and serious adverse event rates.
Tsilimparis and colleagues report that 1,274 patients from 19 centers were included in the study. The median age of these patients, they note, was 74 years (interquartile range 68-79) and just over three-quarters (75.7%) were men. In terms of pathology, there were slightly more thoracoabdominal aortic aneurysms than complex AAAs in the study—54.3% versus 45.7%. The majority of patients presented electively (65.5%), while 24.6% had symptomatic aneurysms and 9.9% had ruptured aneurysms.
The authors report that 83.1% of patients underwent fenestrated repair, 3.6% underwent branched repair, and the remaining 13.4% underwent a combination of both. They note that the majority of patients (85.8%) had three or more target vessels involved.
Tsilimparis et al show an overall technical success rate of 94%. They state that this was the accurate result in elective procedures, with the number being slightly lower in symptomatic patients (93.4%) and slightly higher in ruptured procedures (95.1%).
Furthermore, they report that the overall 30-day mortality was 5.8%, with a lower rate of 4.1% in elective cases and a higher rate of 7.6% and 12.7% in symptomatic and ruptured aneurysms, respectively.
Serious adverse events occurred in just over a quarter (25.2%) of cases, Tsilimparis and colleagues continue, pointing out that this occurred in slightly fewer elective cases (23.1%) and slightly more symptomatic (27.8%) and ruptured cases (30.3%) than average.
Finally, the authors report that freedom from reintervention was 73.8%, 61.8%, and 51.4%; primary target vessel patency was 96.9%, 93.6%, and 90.3%; and overall survival and freedom from aortic-related mortality were 82.4%/92.9%, 69.9%/91.6%, and 55%/89.1% at one, three, and five years, respectively. The median follow-up was 21 months.
Tsilimparis and colleagues conclude that PMEGs were a “safe and effective” treatment option for elective, symptomatic and ruptured complex aortic aneurysms in this international, multicenter study. “Long-term data and future prospective studies are needed for a more robust and detailed analysis,” they explain.
