“DA-Fix” Drain: An Innovative Noncontact Chronic Subdural Hematoma Drainage System

Abstract

Introduction

Recurrent chronic subdural hematoma (CSDH) is a major global problem with high morbidity and mortality. Despite being a treatable entity with a simple procedure such as burr hole and evacuation, it has a high recurrence rate. The placement of a subgaleal drain, which is the current standard of care, is a suboptimal method for preventing recurrences.

Materials and Methods

The senior author devised a new type of burr hole cap (DA-Fix, GPS Precisions, Ghaziabad, India; patent pending) made of medical grade titanium with an integrated subdural evacuation system, with a suction port in the center, designed in such a way as to be completely atraumatic to the underlying brain and vessels. Once fixed, a no. 12 suction drain is connected to the nozzle arising from the center of the DA-Fix and tunneled out away from the primary incision site. This drain was then connected to the suction drain system under half negative suction. We present our initial clinical experience with this novel DA-Fix drain in patients with CSDH.

Results

Three patients with CSDH underwent burr hole drainage and placement of the DA-Fix drain. All three patients had the suction drain placed for 4 to 6 days (mean: 5 days) and had good radiological outcomes. Two patients could be discharged, and one patient died in the hospital on the 11th day due to sudden myocardial infarction.

Conclusion

We describe a novel noncontact, controlled suction integrated into a burr hole cap with a detachable suction attachment. This invention has the potential to dramatically reduce the recurrence and complication rates of subdural hematoma(s).

Keywords

burr hole - DA-Fix - innovation - recurrent - subdural hematoma

Introduction

Background

Subdural collections, which may occur posttrauma or spontaneously, are usually in the form of hematomas or effusions. Subdural hematomas (SDHs) can go unnoticed over weeks or months, also known as chronic subdural hematomas (CSDHs), and are responsible for gradual deterioration of the patients, especially the elderly population. It has tripled in octogenarians over the past 30 years and is expected to become the most common cranial neurosurgical condition among adults in the next decade. In the pre-CT era, the patients were diagnosed based on the clinical presentation and, in many cases, patients were left with a permanent morbidity due to delayed diagnosis or even deaths in patients not diagnosed on time.[1] [2] [3] [4] [5]

Patients with CSDH usually present with headaches or in some cases with weakness ranging from limb weakness to significant hemiparesis. Often seizures or loss of consciousness would ensue in the cases where management is delayed. The most common mode of management preferred in CSDH is surgery if the patient is symptomatic or there is radiological evidence of mass effect on head CT. Although the type of surgical treatment has been debatable since decades, burr hole evacuation and drainage are the most commonly performed surgical procedure. There are various other techniques of surgical evacuation of CSDH like craniotomy, trephination, and twist drill perforation.[6] [7] [8] [9] Recurrent CSDH is a major global problem with high morbidity and mortality. Despite the fact that most CSDHs resolve after a simple burr hole, recurrence of CSDH remains a complex entity to resolve. Some studies have reported a recurrence rate of CSDH after operation of approximately 5 to 33%.[3]

Objectives

Our aim is to demonstrate the utility of DA-Fix based on our experience regarding cases of CSDH or acute-on-chronic SDH managed using this novel form of burr hole capping drainage device to prevent or reduce any collection of blood or air in subdural space in the immediate postoperative period. This innovation is being evaluated based on its ease of application, safe utility, and assessment of postoperative advantages and disadvantages. We present our initial clinical experience with this novel DA-Fix drain in patients with CSDH.

Materials and Methods

Study Design

This is a prospective, single-arm, single-center case series evaluation. It was performed over 1 month in our institute. Informed consent for the procedure was taken from the patients or attendants of the patients with impaired cognition due to SDHs.

Place of study: The study was conducted at the Jai Prakash Narayan Trauma Center (JPNATC), AIIMS, New Delhi.

Novel device in study: The senior author (D.A.) has devised a new type of burr hole cap (DA-Fix, GPS Precisions, Ghaziabad, India; patent pending) made of medical grade titanium with integrated subdural evacuation system, with a suction port in the center, designed in such a way as to be completely atraumatic to the underlying brain and vessels ([Fig. 1]). The suction port is also designed in such a way to allow snug fitment of off-the-shelf suction tube(s) with the ability to detach from the port easily, while the burr hole cap is fixed postoperatively.

Fig. 1 A schematic representation of the DA-Fix with its various parts. The suction port located centrally allows a better drainage of contents from the subdural region.

Inclusion Criteria

• Patients older than 18 years with a history of trauma and evidence of CSDH on head CT.

• Anxious patients with the above presentation not fit for local anesthesia or mild sedation.

• Patients not on any anticoagulation or low-dose anticoagulants, if any.

Exclusion Criteria

• Patients with SDHs of acute onset.

• Patients not willing for general anesthesia or surgical evacuation.

• Patients on dual antiplatelets or anticoagulants.

Methodology

Three contiguous patients admitted with chronic or acute-on-chronic SDH were operated with burr hole evacuation and DA-Fix drainage. Patients' preoperative evaluation included their age, gender, past history of any significant head trauma, and details of trauma such as time of injury, radiological imaging, and management executed. Complete neurological examination was done, and laboratory investigations were done with attention to coagulation profile or any hepatic derangements. Patients were radiologically evaluated using head CT (noncontrast) and then planned for surgical management.

Surgical Technique

All patients were operated under general anesthesia as deemed unfit for local anesthesia by the treating surgeon.

Position: Supine position with the head rotated to the other side; a pillow was placed under the ipsilateral shoulder.

Two curvilinear scalp incisions between 3 and 4 cm down to the periosteum were each made, a fingerbreadth above the stephanion region and a fingerbreadth behind the parietal eminence, respectively ([Fig. 2]). This was followed by periosteal cutting using the diathermy knife allowing skull bone exposure. Burr holes of 14-mm diameter using the Hudson brace or Midas Rex high-speed drill (with burr hole attachment) were then performed, followed by dural cauterization using the bipolar cautery ([Fig. 3]). Cruciate durotomy using a no. 15 blade scalpel was performed, followed by cauterizing the dural flap leaflets against the burr hole bony edges by bipolar forceps, creating a circular dural defect. The outer vascular fibrous membrane ([Fig. 4]) was penetrated and hematoma fluid evacuated; then, irrigation of the subdural space by saline was performed, allowing slow and steady drainage of the hematoma till the fluid coming out was clear.

Fig. 2 Surface marking of the planned incisions in the stephanion region anteriorly and around parietal eminence posteriorly. The two incision markings have been extrapolated to mark the area of flap for craniotomy in the event that the evacuation is not completed successfully via the burr hole.

Fig. 3 A burr hole made using the Hudson brace can be seen with the underlying dura. Any bleed from bony edges should be stopped using bone wax and the dural surface should be carefully cauterized followed by a cruciate incision to expose the subdural membrane.

Fig. 4 Opened up dura postcruciate incision and cauterized. Underlying the dura, we can see a dirty looking reddish-brown membrane of subdural hematoma. This membrane is opened up and meticulously cauterized and the “motor oil” like fluid is allowed to escape, giving the brain a space to expand.

The DA-Fix is placed into the burr hole and fixed to the outer cortex of bone using 3- to 4-mm screws. Once fixed, a no. 12 suction drain is connected to the nozzle arising from the center of the DA-Fix and tunneled out away from the primary incision site ([Figs. 5] and [6]). This drain was then connected to the suction bottle system under half negative suction ([Figs. 7] and [8]).

Fig. 5 The DA-Fix fits exactly into the burr hole site and is fixed to the bone using self-tapping screws. The Romo Vac no. 12 drain is connected on to the suction port.

Fig. 6 After connecting the drain to the DA-Fix, the distal part of the drain is tunneled out away from the primary incision site at least 2 to 3 fingerbreadths away.

Fig. 7 The Romo Vac bag used for connecting to the tunneled out drain attached to the DA-Fix.

Fig. 8 The drain bag is compressed to create a pressure of a half suction as can be seen in the image.

Outcome: Assessment was done based on the comparative subdural collection between the pre- and postoperative head noncontrast CT (NCCT). The drain efficacy was assessed based on any significant reduction in the postoperative collection over a period of 4 to 6 days resulting in the following:

1. Satisfactory expansion of the brain within the calvaria.

2. Significant reduction of any postoperative hematoma, pneumocephalus, or any other collection.

Results

Case Descriptions

Case 1

History and diagnosis: An 80-year-old man with a known case of CAD with recurrent episodes of angina on low-dose anticoagulants presented with a history of fall 12 days ago. The patient was investigated, evaluated, and admitted on admission and diagnosed with left-side acute-on-chronic SDH. His Glasgow coma scale (GCS) on arrival was E2VetM5 with both pupils sluggishly reacting. Considering the age, high risk of complications related to decompressive craniectomy, and history of angina, the patient was planned for surgical evacuation.

Intervention: The patient was taken up for burr hole evacuation and DA-Fix drainage.

Course and Outcome

Clinical: Postoperatively the patient became E4V5M6 drowsy after extubation.

Radiological: Post-op scan revealed intracalvarial pneumocephalus with residual bleed, which reduced subsequently by postoperative day (POD) 3 and 5 ([Fig. 9]).

Fig. 9 Noncontrast CT head (axial images) showing preoperative and postoperative scans of case 1. It can be seen that the pneumocephalus has substantially reduced on postoperative day (POD) 5.

End point: The drain was removed on POD 6. However, the patient developed sudden onset arrhythmias and MI on POD 11 with a positive troponin I. The patient unfortunately succumbed to cardiac causes and died on POD 12.

Case 2

History and diagnosis: A 77-year-old man presented with complaints of gait disturbance and history of repeated falls and left-side hemiparesis for 1 month. The patient was investigated, evaluated, and admitted on admission and diagnosed with right-side CSDH.

Intervention: Right-side burr hole evacuation with evacuation of SDH and DA-Fix drainage.

Course and Outcome

Clinical: The patient had improvement in weakness on the left side in the postoperative period ([Fig. 10]).

Fig. 10 Noncontrast CT head (axial images) showing preoperative and postoperative scans of case 2. A bony window image in axial section can be seen with the implants in situ.

Radiological: There was reduction in subdural collection in the postoperative CT scan as compared with the preoperative scan.

End point: The drain was removed on POD 5 and the patient was discharged uneventfully.

Case 3

History and diagnosis: An 80-year-old man presented with headache, loss of memory, insomnia, and increased frequency of micturition. The patient was investigated, evaluated, and admitted on admission and diagnosed with right CSDH ([Fig. 11]).

Fig. 11 Noncontrast CT head (axial images) showing preoperative and postoperative scans of case 3.

Intervention: Right-side burr hole evacuation with evacuation of SDH and DA-Fix drainage.

Outcome

Clinical: The patient had an improvement in headache in the post-op period.

Radiological: There was moderate reduction in the subdural collection in the postoperative period.

End point: The drain was removed on POD 4, and the patient was discharged uneventfully.

Discussion

Surgical evacuation of subdural collection causing mass effect is the gold standard neurosurgical treatment even today. However, the use of drains for post-op drainage has been a subject of controversy, with ongoing debate due to lack of consensus.

Santarius et al[10] demonstrated lower recurrence rates in patients in whom subdural or subgaleal drain was used as compared with no drain group at 6 months of follow-up demonstrating the benefits of using a closed drainage system. Gazzeri et al[11] and Zumofen et al[12] reported fresh intracranial hematoma(s) with the use of subdural drain. Although studies have shown that subdural and subgaleal drainage systems have a higher cure rate and a lower risk of recurrence,[13] they both have significant disadvantages. It is dangerous to place any kind of drain inside the subdural space due to risk of injury to the friable brain and/or vessels. On the other hand, a subgaleal drain is not directly communicating with the subdural space and hence is highly inefficient in draining the CSDH. The DA-Fix fits into the burr hole with no protruding parts within the subdural space, hence providing with the drainage advantage of subdural drain and a noninvasive attribute similar to the subgaleal drainage system. Since the DA-Fix is not in direct contact with the brain tissue and inner membranes of CSDH, theoretically, there is no risk of acute cerebral hemorrhage, thus making it favorable for high-risk patient(s).

Conclusion

We describe a novel noncontact, controlled suction integrated into a burr hole cap that has not been tried/designed before. Our invention provides a safe and efficient way of draining the CDSH with a novel detachable suction attachment. This invention has the potential to dramatically reduce the recurrence and complication rates of CSDH.

Conflict of Interest

None declared.

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Publication History

Article published online:
09 April 2025