The Story Behind

Evidences & Proof

 

Below is the most important paper showing the futility of traditional surgery for patients with brain hemorrhage. The death rate for patients is as high as 36% and the unfavorable outcome is 74% (including the patients who died)!

 

Mendelow AD, Gregson BA, Fernandes HM, Murray GD, Teasdale GM, Hope DT, Karimi A, Shaw MD, Barer DH; STICH investigators. Early surgery versus initial conservative treatment in patients with spontaneous supratentorial intracerebral haematomas in the International Surgical Trial in Intracerebral Haemorrhage (STICH): a randomised trial. Lancet. 2005 Jan 29-Feb 4;365(9457):387-97. PubMed PMID: 15680453.

 

 

 

 

So it is obvious that medical treatment and traditional surgery both failed in the treatment of these patients. A group of brain surgeons started the "minimally-invasive surgery(MIN)". In order to remove the blood clot from the brain, surgeons need to work through the normal brain tissue covering the clot. However, traditional surgery requires a 3x3cm brain retraction which is a great damage to normal brain tissue. Therefore, MIN is developed to remove the clot with minimal damage to the brain (compared to traditional surgery)  and it can be done with stereotactic guidance or endoscopic enhanced aspiration.

 

After years of development, we have finally shown in both randomized trials of thrombolytic enhanced aspiration & endoscopic-enhanced aspiration with or without stereotaxis have reported increased clot removal and decreased mortality. This was written in the latest "Guidelines for the Management of Spontaneous Intracerebral Hemorrhage A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association 2010". 

 

Morgenstern LB, Hemphill JC 3rd, Anderson C, Becker K, Broderick JP, Connolly ES Jr, Greenberg SM, Huang JN, MacDonald RL, Messé SR, Mitchell PH, Selim M, Tamargo RJ; American Heart Association Stroke Council and Council on Cardiovascular Nursing. Guidelines for the management of spontaneous intracerebral hemorrhage: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2010 Sep;41(9):2108-29. doi: 10.1161/STR.0b013e3181ec611b. Epub 2010 Jul 22. PubMed PMID: 20651276.

 

 

 

 

 

There is also a meta-analysis (with strong clinical evidences from 1955 patients) showing the better surgical result for patients using MIN compared to the traditional surgery. 

 

Zhou X, Chen J, Li Q, Ren G, Yao G, Liu M, Dong Q, Guo J, Li L, Guo J, Xie P. Minimally invasive surgery for spontaneous supratentorial intracerebral hemorrhage: a meta-analysis of randomized controlled trials. Stroke. 2012 Nov;43(11):2923-30. doi: 10.1161/STROKEAHA.112.667535. Epub 2012 Sep 18. PubMed PMID: 22989500.

 

 

 

 

In additional to the better outcome, we have also shown that this is the most cost-effective way of treating patients with better recovery. From the health care system's point of view, MIN decrease the hospital stay and expenditure mainly by avoiding surgical complications.  

 

Cho DY, Chen CC, Chang CS, Lee WY, Tso M. Endoscopic surgery for spontaneous basal ganglia hemorrhage: comparing endoscopic surgery, stereotactic aspiration, and craniotomy in noncomatose patients. Surg Neurol. 2006 Jun;65(6):547-55; discussion 555-6. PubMed PMID: 16720167.

 

The problem with MIN is that it is hard to learn (there is a steep learning curve), there is technical barrier that may make the surgery difficult even for experienced surgeons, and that it can only be applied in medical centers (right now we estimated that only 3-5% of the patients are lucky enough to recived this kind of surgery). Since the publish of these important literature, surgeons world wide has been interested in adopting this technique, but we know it is not easy. That's why we want to make it a device - a device as solution, that is easy to use and help more neurosurgeons saves lives also improve patient outcome. 

 

Til now, we have proof of concept study in 198 patients already. A part of our results have been published in the literature, which has one of the best clinical results to date. Using our proprietary micro-invasive method we have successfully reduced the mortality rate to 6% and morbidity to 5% in addition to a shorter operation time, less blood loss, smaller wound, and better recovery. 

 

Kuo LT, Chen CM, Li CH, Tsai JC, Chiu HC, Liu LC, Tu YK, Huang AP. Early endoscope-assisted hematoma evacuation in patients with supratentorial intracerebral hemorrhage: case selection, surgical technique, and long-term results. Neurosurg Focus. 2011 Apr;30(4):E9. doi: 10.3171/2011.2.FOCUS10313. PubMed PMID: 21456936.