Researchers have reported a 94% technical success rate among other key findings from a recent international, multicentre, single-arm cohort study of physician-modified endografts (PMEGs) for thoracoabdominal and complex abdominal aortic aneurysm (AAA) repair. The work has been published in the American Heart Association (AHA) journal Circulation.
Nikolaos Tsilimparis (Maximilian University Hospital, Munich, Germany) and colleagues note in their introduction that, despite the widespread use of PMEGs in thoracoabdominal and complex AAAs, “robust” data on their safety and effectiveness in these pathologies are lacking. Generally, they write, previous data are “limited to small, single-centre studies”.
It was the investigators’ aim, therefore, to perform an international, multicentre study analysing the outcomes of PMEGs in elective, symptomatic and ruptured thoracoabdominal and complex AAAs.
In their research article, Tsilimparis et al detail that they defined variables and outcomes according to the Society for Vascular Surgery reporting standards and collected and analysed device modification and procedure details to inform their analysis.
In terms of outcomes, the authors share that efficacy was measured by technical success and safety by major adverse events and 30-day mortality. Additionally, the investigators looked at follow-up outcomes including reinterventions, endoleaks, target vessel patency rates and overall and aortic-related mortality. They performed multivariable analysis with the aim of identifying predictors of technical success, 30-day mortality and major adverse event rates.
Tsilimparis and colleagues state that 1,274 patients from 19 centres were included in the study. The median age of these patients, they detail, was 74 (interquartile range, 68–79) and just over three quarters (75.7%) were men. With relation to pathologies, there were slightly more thoracoabdominal aortic aneurysms than complex AAAs included in the study—54.3% vs. 45.7%, respectively. The majority of patients presented electively (65.5%), while 24.6% had symptomatic aneurysms and 9.9%, ruptured aneurysms.
The authors relay that 83.1% of patients were submitted to a fenestrated repair, 3.6% to a branched repair and the remaining 13.4% to a combination of the two. They note that the majority of patients (85.8%) had three or more target vessels included.
Tsilimparis et al reveal an overall technical success rate of 94%. They specify that this was the exact result for elective cases, with the figure being slightly lower (93.4%) for symptomatic patients and slightly higher (95.1%) for ruptured cases.
In addition, they share that 30-day mortality was 5.8% overall, identifying a lower rate of 4.1% in elective cases and higher rates of 7.6% and 12.7% in symptomatic and ruptured aneurysms, respectively.
Major adverse events occurred in just over a quarter (25.2%) of cases, Tsilimparis and colleagues continue, noting that they occurred in slightly fewer elective cases (23.1%) and slightly more symptomatic (27.8%) and ruptured cases (30.3%) than the 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 was 82.4%/92.9%, 69.9%/91.6% and 55%/89.1% at one, three and five years. Median follow-up was 21 months.
Tsilimparis and colleagues summarise that PMEGs were a “safe and effective” treatment option for elective, symptomatic and ruptured complex aortic aneurysms in this international, multicentre study. “Long-term data and future prospective studies are needed for more robust and detailed analysis,” they state.
