Research on Hybrid Operation Technique in the Treatment of Complex Brain Arteriovenous Malformations
Research on Hybrid Operation Technique in the Treatment of Complex Brain Arteriovenous Malformations
Complex brain arteriovenous malformations (bAVMs) in ≥3 Spetzler-Martin grades have long been
 challenges among cerebrovascular diseases. None of the traditional methods, such as
 microsurgical operation, endovascular intervention, or stereotactic radiotherapy, can
 completely eliminate complex bAVMs without a risk of neural function deterioration. The
 multistaged hybrid operation solved part of the challenge but remained risky in the
 installment procedures and intervals. The one-staged hybrid operation was applied in the
 surgical treatment of cerebrovascular diseases and proved to be a potentially safe and
 effective method for curing complex bAVMs. However, lacking the support of high-level
 evidence, its advantages remain unclear. This study was proposed to validate the benefits and
 risks of one-staged hybrid operation in the treatment of complex bAVMs, as well as its
 indications, key technologies, and workflows.
The study is being conducted from Jan 2016 to Dec 2020 with 20 cooperation units. It consists
 of 2 sets. The registry set is designed as a prospective real-world registry. The trial set
 is designed as a prospective pragmatic clinical trial, specifically for the patients with
 perforating arterial feeders. The two sets share a common grouping: the traditional operation
 group and the one-staged hybrid operation group. The assignment is based on the clinical
 condition in the registry set and is randomized in the trial set. End points will be
 evaluated at scheduled time points. The safety and efficiency of one-staged hybrid operation
 in treating complex bAVMs will be validated.
Inclusion Criteria:

 1. patients of all ages;

 2. diagnosed with arteriovenous malformations (AVMs) in brain parenchyma (including
 cerebrum and cerebellum) by DSA, with/without dura arteriovenous fistula;

 3. with any operative indications as follows: (1) with stable hematoma or history of
 hemorrhage due to bAVMs, and allowed selective operation; (2) with recurrent epilepsy
 seizure, having failed treatment with antiepileptic drugs (AEDs); (3) with induced
 deterioration of neurological functions;

 4. with Spetzler-Martin Grades from I to IV;

 5. who provide informed consent.

 Exclusion Criteria:

 1. >70 years old with no significant hemorrhagic risk of bAVMs;

 2. with Spetzler-Martin Grade ≥V;

 3. accompanied by severe chronic disease, organ dysfunction, or malignant tumor that
 cannot tolerate the operation;

 4. allergic to iodinated contrast agent;

 5. unable to give informed consent.