I’m proud to announce that Tallahassee Neurological Clinic (TNC) is participating the NEWTON2 trial, and we are currently enrolling patients. NEWTON2 is a phase 3 randomized trial evaluating intraventricular nimodipine (EG-1962) versus standard of care oral nimodipine in patients with subarachnoid hemorrhage due to ruptured brain aneurysms. This makes Tallahassee the only center in the region that provides full service cerebrovascular care and cutting edge stroke and brain aneurysm research.
Participating in well designed clinical trials, such as NEWTON2, helps ensure that the care we provide in the future will be better than the care we provide today. I’m very proud that we are participating in this trial, as it helps advance our field within neurosurgery, and hopefully will improve outcomes for patients with subarachnoid hemorrhage.
TNC is the only neurosurgical group in the region with three endovascular neurosurgeons, who provide comprehensive care for ischemic stroke, hemorrhagic stroke, brain aneurysms, and carotid disease. We have an active clinical research division and have participated in numerous device and drug trials for neurosurgical patients.
Endovascular Today – Endovascular Advances in the Treatment of Cerebral Aneurysms (February 2017)
This article is a great overview of the development of new neuroendovascular techniques and technology for the treatment of cerebral aneurysms. I am proud to say that Tallahassee Neurological Clinic and Tallahassee Memorial Healthcare were involved in clinical trials for some of these devices (PulseRider and Barrel) and we routinely use Pipeline Flex in our practice.
Check out the full article by clicking the link below.
Tallahassee Neurological Clinic and Tallahassee Memorial Hospital have been selected as a site for the NEWTON2 trial, with Dr. Lawson as the local site primary investigator. This phase 3 trial is designed to study the efficacy of a novel substance compared to oral nimodipine for prevention of vasospasm in subarachnoid hemorrhage. This makes TNC and the TMH Comprehensive Stroke Center the only center in the region participating in phase 3 research in hemorrhagic stroke & subarachnoid hemorrhage treatments.
Institutional Review Board approval has not yet been granted, but we hope to finalize this in the next few months. The study is funded by Edge Therapeutics.
Aneurysm coiling is a minimally invasive technique for treating a brain aneurysm, where the entire procedure is performed from inside the blood vessel (an endovascular procedure). This is in contrast to the other method of treating brain aneurysm, surgical clipping. Traditionally, brain aneurysms were treated with open surgery, called clipping, where a small metal clip was placed at the neck of an aneurysm to prevent bleeding. Clipping has been the standard treatment of aneurysms since the 1960’s, and the procedure is highly invasive. Clipping involves making an incision on the scalp, removing part of the skull (a craniotomy), and then placing a clip at the base of the aneurysm.
In the 1990’s coiling was developed as a minimally invasive technique to treat brain aneurysms, and it was the first viable alternative to clipping surgery. Coiling “fixes” a brain aneurysm from inside the blood vessel, using long catheters and devices that are navigated to a brain aneurysm from a blood vessel in the patient’s leg. In much the same way that cardiologists treat heart disease with “heart catheterization” the endovascular neurosurgeon treats brain aneurysms with catheterization based endovascular procedures, or coiling.
At TMH we treat both ruptured brain aneurysms (see my post on
Subarachnoid Hemorrhage) as well as unruptured aneurysms. Patients who have a ruptured aneurysm have subarachnoid hemorrhage, and they are often critically ill and in the intensive care unit. Many patients who undergo coiling have unruptured aneurysms, or aneurysms that have not bled. The goal for these patients is to reduce or eliminate the risk of bleeding from the aneurysm in the future by treating high risk aneurysms with coiling.
The goal of coiling is to fill the aneurysm with platinum coils, or small devices that cause blood within the aneurysm to clot. This eliminates blood flow in the aneurysm and prevents future bleeding.
Most coiling procedures are done with the patient under general anesthesia using a biplane fluoroscopy unit. This specialized x-ray equipment is very similar to that seen in a cardiac cath lab, but it has additional features for cerebrovascular interventions.
The first step in any coiling procedure is to perform a diagnostic angiogram. This involves taking high resolution images of the blood vessels of the brain, to identify and understand the anatomy of an aneurysm. Next, a guide catheter is navigated from the femoral artery in the leg, up the aorta, and into one of the major blood vessels supplying the brain. The guide catheter is usually positioned in one of the carotid or vertebral arteries.
After placing the guide catheter, a microcatheter is navigated within the guide catheter and then up into the blood vessels of the brain over a very small wire. This microcatheter is then carefully advanced into the aneurysm. Next, coils are placed within the aneurysm through the microcatheter. Once the aneurysm is treated, the catheters are removed and the patient is awakened.
There have been numerous advances in coiling technology over the last 10-15 years. The pace of innovation in endovascular neurosurgery is astounding, as many of the devices on the market just 10 years ago are obsolete. At TMH, we are fortunate to be able to participate in advanced device trials, helping evaluate the next generation of medical devices. Drs. Lawson and Oliver perform traditional coiling as well as advanced stent-assisted coiling, balloon-assisted coiling, and embolization using flow diversion devices.
Subarachnoid Hemorrhage, or SAH, is a medical condition where there is bleeding into the subarachnoid space. This space is just outside of the brain and spinal cord, but inside the dura, or the tough covering over the brain and spinal cord. The subarachnoid space contains cerebrospinal fluid, or CSF, which protects the brain, as well as major blood vessels that supply the brain with oxygen and nutrients.
The most common cause of subarachnoid hemorrhage is trauma. When a patient strikes their head, such as in an automobile accident or fall, blood vessels in the subarachnoid space may tear and bleed, causing traumatic subarachnoid hemorrhage. This is usually treated with observation and placement of an intracranial pressure monitor, using the Guidelines for the Management of Severe Traumatic Brain Injury.
Patients who present with subarachnoid hemorrhage who have not had a traumatic injury have spontaneous subarachnoid hemorrhage. This is commonly due to an abnormality of the blood vessels within the subarachnoid space that has caused them to rupture and bleed on their own. The most common vascular abnormality leading to subarachnoid hemorrhage is a cerebral aneurysm, or brain aneurysm, but other vascular conditions can also cause subarachnoid hemorrhage. When a patient comes to the hospital with subarachnoid hemorrhage, studies such as CT Angiography or Cerebral Angiography are performed to look for a brain aneurysm or malformation that may have caused the bleeding.
Aneurysmal Subarachnoid Hemorrhage is a medical emergency. It strikes roughly roughly 30,000 people annually in the United States. Many of these people are critically ill. Up to 40% of patients with subarachnoid hemorrhage from a ruptured aneurysm die, and many pass away quickly. Symptoms of SAH include sudden onset severe headache (the worst headache of my life, or thunderclap headache), nausea, vomiting, lethargy, coma, and sometimes focal neurological impairment. They may also develop seizures, elevated pressure in the brain or hydrocephalus, and aneurysm re-rupture. When patients arrive in the Emergency Department with SAH, they will often require intubation (placement of a breathing tube) and transfer to a specialized hospital, such as a Comprehensive Stroke Center (CSC).
SAH patients are then cared for in neurological intensive care units, usually at Comprehensive Stroke Centers. The goal of treatment is to support the patient, control blood pressure, and give medications to prevent a complication called vasospasm. About half of all SAH patients will need a ventricular drain to relieve hydrocephalus, a common complication of subarachnoid hemorrhage. The ventricular drain is a small catheter or tube that is placed into the fluid-filled spaces in the brain, the ventricles, which drains fluid to a collection system outside of the patient. This ventricular drain helps reduce the buildup of cerebrospinal fluid and helps relieve elevate intracranial pressure.
Once the patient with SAH is stabilized, the goal is to repair the aneurysm so that it cannot bleed again. Usually, this is done within the first 24 hours after admission to the hospital. Aneurysm repair does not generally change the condition of the patient, but it does prevent further bleeding from occurring. A brain aneurysm can be repaired in one of two ways, microsurgical clipping (open surgery) or endovascular embolization (often called coiling). Microsurgical clipping is done in the operating room, and a craniotomy is performed. The aneurysm is then “fixed” when a small titanium clip is placed across the bottom of the aneurysm (or neck), which prevents future bleeding. There are risks and benefits to each of these treatments, but most ruptured aneurysms at TMH are treated with endovascular embolization (coiling).
Aneurysm embolization (coiling) is performed in a specialized cath lab, similar to a cardiac cath lab or interventional radiology suite, and is usually performed by an Endovascular Neurosurgeon. Small catheters are placed into the femoral artery in the groin and navigated up into the head, where aneurysms are treated from inside the blood vessels. Click here to learn more about Endovascular Neurosurgery.
The first 10-12 days after aneurysm rupture are usually spent in the ICU, and then the focus of care shifts towards rehabilitation. The average stay in the hospital is about 3 weeks. Many patients will require inpatient rehabilitation after aneurysmal subarachnoid hemorrhage. After a patient leaves the hospital, continued follow up with the neurosurgeon is critical.
Tallahassee Memorial Hospital received the American Stroke Association Get with the Guidelines Gold Plus recognition for excellence and consistency in compliance with stroke center quality measures. Great job team!
WCTV featured Dr. Lawson’s patient, who underwent cerebral aneurysm treatment with an investigational device, on the local news. Please take a look at the WCTV story.
Drs. Lawson and Oliver at Tallahassee Neurological Clinic (TNC) are enrolling patients in the Barrel Trial, a study to evaluate the safety and efficacy of a new intracranial stent. TNC/TMH is one of only 28 centers in the United States selected to participate in the trial.
Dr. Lawson & Dr. Oliver have successfully treated over 100 cerebral aneurysms at Tallahassee Memorial Hospital. In just two years, TMH has become a major regional referral center for brain aneurysms and other cerebrovascular disorders.
In September of 2012 Tallahassee Memorial Hospital opened a state-of-the-art facility for performing complex neuro-endovascular procedures. One year later, 167 cases have been performed, dramatically improving the quality and availability of cerebrovascular care in the region.
Since the opening of this facility, we have successfully treated the following conditions:
Acute Stroke
Ruptured Brain Aneurysms
Unruptured Brain Aneurysms
Arteriovenous Malformations
Carotid Stenosis
Idiopathic Intracranial Hypertension
The Tallahassee Democrat reports on the new, state-of-the-art neurovascular suite that has opened at Tallahassee Memorial Hospital. This new facility represents a dramatic advance in the level of care that can be provided regionally, including cutting edge treatment for brain aneurysms, arteriovenous malformations, and acute stroke intervention. It is the first facility of its kind in the region built for the purpose of treating vascular disorders of the brain and spinal cord. Please visit the Tallahassee Democrat to read more.