Predictors of Procedural Outcome after Surface-Modified Flow Diverter Treatment for Intracranial Aneurysms: An Update from the INSPIRE-A Registry
Abstract Body: Introduction Although flow diverters (FD) are a long-established treatment-option for brain aneurysms, the evidence of data associated with therapy success is still based on relatively small heterogeneous studies. Recent data from a large prospective registry with highly standardized, independent adjudication might provide more insights.
Methods The INSPIRE-A registry is a prospective, single arm study of brain aneurysms treated with commercially available Medtronic devices, including latest FD technology with surface modifications. The registry collects data from 70 centers in 21 countries. Results are adjudicated by an independent Imaging Core Laboratory and a Clinical Events Committee. The association of patient characteristics, aneurysm details, and procedural variables with aneurysm occlusion (Raymond–Roy occlusion classifications [RROC I]), and in-stent stenosis at 1 year follow-up (FU) were tested using multivariable logistic regression analysis. Results 786 patients were analyzed. The median age was 55 years (IQR, 46-64) and 79.6% (626) were female. Most frequently, aneurysms were in the anterior circulation (89.8 %, 706) with highest rates of ICA-Aneurysms (75.3%, 592) in the C6 (52.7%, 312/592). Median diameter and neck width of aneurysms were 7.2 mm (IQR, 5-11) and 6.5 mm (IQR, 4-10), respectively. 91.7% (719) of aneurysms were saccular. The Pipeline Flex with Shield technology (Medtronic, Irvine CA) device was deployed in 58% (456), the Pipeline Vantage with Shield technology (Medtronic, Irvine CA) device in 42% (330). Adjunctive coiling was used in 19.8% (156). At 1 year FU, RROC I was observed in 74.3% (584) of cases. In multivariable analysis, increasing age (OR, 0.97, 95% CI, 0.96-0.99; p<0.001), male sex (OR, 0.51, 95% CI, 0.34-0.77; p=0.001), and adjunctive coiling (OR, 1.62, 95% CI, 1.0-2.56; p=0.037) were significantly associated with RROC I. There was a tendency of higher occlusion rates in ICA-Aneurysms (OR, 2.91, 95% CI, 1.42-2.56; p=0.076). In-stent stenosis occurred in 2.2% (17) and was associated with fusiform morphology at 1 year FU (OR, 4.82, 95% CI, 1.28 -14.35; p=0.018).
Conclusion Treatment with surface-modified FD for intracranial aneurysms led to favorable rates of complete aneurysm occlusion at 1 year FU. This large, homogenous, and independently adjudicated data set suggests that age, gender, and adjunctive coiling were associated with complete aneurysm occlusion. Fusiform morphology was associated with in-stent stenosis.
Meyer, Lukas
( University Medical Center Hamburg
, Hamburg
, Germany
)
Kniep, Helge
( University Medical Center Hamburg
, Hamburg
, Germany
)
Szikora, Istva
( National Institute of Clinical Neurosciences Budapest Hungary
, Budapest
, Hungary
)
Martínez-galdámez, Mario
( Neuroradiology Unit at the University Clinical Hospital of Valladolid
, Valladolid
, Spain
)
Lamin, Saleh
( Queen Elizabeth Hospital Birmingham
, Birmingham
, United Kingdom
)
Holtmanspoetter, Markus
( Institute of Diagnostic and Interventional Neuroradiology, Paracelsus Medical University
, Nürnberg
, Germany
)
Turjman, Francis
( Hôpital Pierre Wertheimer
, Lyon
, France
)
Spelle, Laurent
( Bicetre University Hospital
, Paris
, France
)
Fiehler, Jens
( University Medical Center Hamburg
, Hamburg
, Germany
)
