This trial is evaluating whether CompuFlo thoracic epidural placement will improve 1 primary outcome and 10 secondary outcomes in patients with Aortic Dissection. Measurement will happen over the course of Immediate-during the procedure.
This trial requires 133 total participants across 2 different treatment groups
This trial involves 2 different treatments. CompuFlo Thoracic Epidural Placement is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.
Aortic dissection progresses in two phases with a sudden onset (generally within a month), but a gradual development of dissection, which can occur years later. Untreated aortic dissection can lead to fatal bleeding, which necessitates immediate surgery with the aortic reconstruction. It is very rare for the acute phase of the dissection to heal spontaneously. It is often diagnosed by CT scan imaging, and is treated by surgical repair or endovascular repair.
5.5 per 100,000 people have been reported to have aortic dissection annually. The peak incidence is in the 5th and 7th decades. The most frequent complications are aortic aneurysms. The sex ratio is less than 1:0.4 for patients under the age of 45 years, and for patients more than 70 years old the ratio is about 1:9.5. Patients more than 80 years of age were found to have an increased risk of complications (complications: aortic dissection 2.7, aortic aneurysms 6.5, pulmonary dissection 1.4). Patients with renal disease were in the group with complications 6.
Individuals with aortic lesions have a higher incidence of cardiovascular risk factors, but it may be clinically difficult to differentiate between dissection (aortitis) and aneurysm. Signs such as tenderness over the left iliac and above the left shoulder, pleuritic chest pain, and lower back pain are suggestive of dissection although aortic aneurysms do not produce these findings. There are significant advantages to imaging with magnetic resonance angiography and the computed tomography angiogram is preferable to chest x-ray for this purpose.
The data suggests a possible aetiology for aortic dissection. More rigorous analyses are needed to further elucidate whether the increased prevalence of dissection among men who have smoked and those with high levels of circulating hormones and cytokines may represent an independent risk, or may be an artefact of the increased prevalence of CAD in men with aortic dissection.
AD can be treated. However, for patients who do not benefit from surgical intervention, there is no guarantee that their symptoms will not recur during the follow-up.
Aortic dissection occurs in 1 out of every 5,500 patients every year in the United States. Over half of patients are male, more than 80% are in their sixth decade of life, and 90% present with symptoms of thoracic aortic dissection. Surgical intervention is the primary treatment for aortic dissection, accounting for approximately 40% of treatment options. Surgical treatment is most often performed within 4 days of dissection onset. Endovascular and endovascular with an aortic reconstruction strategy are important new approaches which are currently being explored to improve outcomes.
Epidural placement alone might be appropriate for certain patients with AAD. The combination of epidural placement with medical management may be effective in some patients, although the potential for a greater complication rate needs to be weighed against the potential benefits.
For this patient population, the incidence of brachial plexus and epidural-related adverse events was very low, with a few instances of transient paresthesias and occasional mild systemic reactions. These side effects are transient and seldom interfere with epidural continuation.
Treatment for acute uncomplicated AAD is associated with better outcomes compared to untreated AAD and is equivalent to treatment of AAD complicated by cardiogenic shock. Treatment with surgical repair is associated with improved long-term survival compared to percutaneous repair of AAD, and seems safe in the subgroup of AAD complicated by cardiogenic shock.
These data are only a guide for referral of patients with aortic dissection for clinical trials; family members should be questioned regarding any history of aortic dissection or disease, and any aortic dissection in a close relative.
In a recent study, findings, 1 of every 10 patients developed pneumothorax. The majority developed pneumothorax after a thoracic epidural placement to treat radicular pain and upper extremity pain from thoracic procedures. The study concludes that patients should be monitored closely for pneumothorax after thoracic epidural placement in this population.
The Compuflo thoracic epidural catheter allows for a continuous and localized infusion of low density and volume solutions, thereby providing comfort to patients and a low risk of neurologic damage. The placement requires a single epidural space, eliminates the need for anesthesia with related complications, and decreases the risk of epidural hematoma. The technique eliminates or reduces the use of needles, resulting in reduced radiation exposure and time required for the procedure. These variables would help a clinician make a quick clinical decision at the bedside.