Hybrid operating room

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Hybrid operating room for cardiological interventions ( Gemelli Clinic )

A hybrid operating room is an operating room that is equipped with imaging systems in the form of angiography systems , computer tomographs or magnetic resonance tomographs . These imaging modalities enable minimally invasive interventions that are less traumatic for the patient. Minimally invasive means that the surgeon does not cause any major surgical wounds to gain access to the part of the body to be operated on, but instead inserts catheters or endoscopes through small openings in the body. In the case of heart surgery, for example, this can avoid a sternotomy . Imaging in the form of mobile C-arms , ultrasound and endoscopy has long been standard equipment in the OR. However, new minimally invasive approaches require better image quality to visualize small anatomical structures and very thin vessels in the heart muscle . This can be achieved through intraoperative rotational angiography. The combination of different imaging modalities and their inherent strengths by means of registration can also bring advantages.

Clinical application areas

Hybrid operating rooms are particularly common in cardiovascular and neurosurgery, but they are suitable for a much wider range of surgical disciplines.

Cardiovascular surgery

Hybrid cardiac surgery operating theater on UKSH Campus Kiel

The treatment of valve diseases and the surgical therapy of arrhythmias and aortic aneurysms can benefit from the imaging options of the hybrid operating room. Intraoperative (3D) imaging is already very common in these areas.

The trend towards endovascular therapy of abdominal aortic aneurysms has promoted the spread of angiography systems in the field of vascular surgery. A hybrid operating theater should be a prerequisite for complex prostheses in particular. It is also well suited for emergency care.

Some surgeons not only use the angiography system to verify correct placement at the end of the procedure, but also plan the procedure using the appropriate software in their angiography system. Since the anatomy changes between the preoperative CT and the intraoperative fluoroscopy due to the positioning of the patient and the insertion of rigid instruments, planning gains precision through the use of intraoperative 3D images. The aorta is automatically segmented on this image, and markings for e.g. B. the ostia of the renal arteries are placed. The contour of the aorta is in turn superimposed with these markings on the live fluoroscopy . If the position of the operating table or C-arm or the angulation of the C-arm is changed, this overlay is adjusted accordingly.

Neurosurgery

In neurosurgery , the areas of application of the hybrid operating room include spondylodesis and the treatment of intracranial aneurysms . In both cases, the hybrid OR was seen as having promising potential to improve clinical outcomes. For spinal surgery, integration with a navigation system can further improve the workflow.

Thoracic surgery and endobronchial interventions

Interventions to diagnose and treat small nodules in the lungs have recently also been carried out in hybrid operating rooms. Interventional imaging offers the advantage of knowing the exact position of the lesions , especially when it comes to small or glass-opaque tumors , metastases or patients with impaired lung function. This enables precise navigation for biopsies and tumor resections in VATS surgery. Above all, it also replaces the haptics that are missing in conventional VATS as a minimally invasive procedure . This new approach can potentially protect healthy lung tissue because the location of the lesion is known precisely and the margin of safety can be reduced. This increases the patient's quality of life after the procedure.

The process of diagnosis and treatment involves three steps:

  1. Identification of nodules on a CT or chest x-ray
  2. Biopsy of the nodes to diagnose the malignancy
  3. If necessary, treatment of the nodules by surgical intervention or radiation therapy (curative approach) or by chemoembolization or ablation (palliative approach)

A hybrid OR can support steps 2 and, in the case of an OR, 3.

biopsy

If there are nodules in the lungs identified on a chest CT scan, a biopsy must be performed to determine whether the lesions are malignant . To do this, a little tissue is removed from the knot with a needle and examined in the laboratory. The needle is inserted through the bronchi or externally through the thorax . In order to ensure that the lesion is actually biopsied and that adjacent healthy tissue is not accidentally examined and thus false negative results are obtained, the exact position of the lesion is determined with imaging (mobile C-arms, ultrasound , bronchoscopy ). The hit rate for the biopsy of small tumors (less than 3 cm) is given as 33 to 50%.

In order to increase the hit rate, angiography systems with better imaging capabilities have proven useful. The advantage is that the patient and their diaphragm remain in exactly the same position during 2D / 3D imaging and the actual biopsy . This achieves a much higher precision than with pre-procedural recordings. The bronchi are visualized in 3D using rotational angiography . The air serves as a natural contrast medium , so the lesions are clearly visible. With the help of software, the lesions to be biopsied can then be marked in the 3D image and a path for the needle can be planned. These 3D images with marks can then access the real-time fluoroscopic image ( fluoroscopy are superimposed anatomically precise). The pulmonologist thus has better orientation and guidance to the lesions. Initial publications on this new method report hit rates of 90% for nodules between 1 and 2 cm in size and 100% for nodules larger than 2 cm.

Operational approach

VATS (video-assisted thoracoscopic surgery) is a minimally invasive procedure for the removal of small lung tumors in order to spare the patient a traumatic sternotomy . The lungs are accessed through small openings, through which a thoracoscope or video camera and surgical instruments are inserted. This process shortens recovery times and can reduce complications, but the surgeon must in locating the lesion on his haptics without. This causes problems in particular with so-called "ground-glass opaque tumors", tumors that are not on the surface and very small lesions. According to studies, the hit rate for tumors smaller than 1 cm can be less than 40%. As a result, more healthy tissue is often removed than is absolutely necessary to provide a margin of safety around the tumor and to ensure that no malignant tissue is left behind. Intraoperative imaging in the OR helps with precise localization and resection of the lesion and can potentially save time and healthy tissue. In order to perform image-guided VATS, a rotational angiography must be performed before the ports are introduced, i.e. before the lung deflates. Only in this way can air be used as a natural contrast medium . After the exposure, needles, hooks and / or contrast media (Lipiodol, Iopamidol) are placed around / in the lesion in a second step in order to ensure their visibility in the X-ray image of the deflated lung. Then the conventional part of VATS begins with the introduction of the thoracoscopy. The imaging system is now used in fluoroscopic (2D) mode, the previously marked lesions and the instruments are now clearly visible so that precise removal is possible. If contrast media was used for marking, it migrates to the surrounding lymph nodes , which can then be removed at the same time.

Orthopedic surgery and traumatology

Complex bone fractures such as pelvic fractures, heel bone fractures or tibial head fractures require the exact placement of screws and other surgical implants in order to ensure the fastest possible treatment of the patient. Minimally invasive surgical interventions are less stressful / traumatic for the patient, which results in a faster recovery of the patient. Nevertheless, the risks of misalignments, subsequent corrections and nerve damage should not be underestimated. The use of an angiography system with a spatial resolution of 0.1 mm and a large image section to display the entire pelvis in just one image provides the surgeon with highly precise images without impairing hygiene (floor-mounted system) or hindering access to the patient (CT). Other surgical procedures that can be optimized through the use of a hybrid operating room are, for example, spinal surgery for degenerative diseases of the spine, scoliosis surgery or traumatic spinal and pathological fractures . The large image section and the high kW rate enable optimal image resolution even in obese patients. Navigation systems or the use of integrated laser guidance systems can support and improve the workflow during the operation.

Laparoscopic surgery

As in other fields of minimally invasive surgery , the first laparoscopic surgeons were ridiculed and the medical profession did not believe in this new technology. Today, laparoscopy is the gold standard for many operations in visceral surgery . Starting with a simple appendectomy , partial kidney resections and partial liver resections, etc., the area of ​​application of medical imaging in laparoscopy is constantly expanding. The image quality, the ability to generate current images of the patient in the "operating position" and the support in guiding the operating instruments favor the use of angiography systems. Partial kidney resections, in which as much healthy tissue as possible is preserved, were described some time ago. The challenges surgeons face include loss of natural 3D vision and loss of sense of touch. Endoscopes and surgical instruments are inserted through small incisions . The surgeon has to rely on the images provided by the endoscope and cannot feel the tissue through the narrow openings. In a hybrid OR, the anatomy can be displayed and updated in real time. 3D images can be merged and / or overlaid with images from live fluoroscopy or the endoscope. This novel imaging possibility can support the surgeon with the minimally invasive approach. Critical anatomy such as B. vessels or a tumor can be bypassed, thus reducing complications. Further scientific research is currently being carried out.

Emergency care for trauma patients

Every minute counts when treating trauma patients . Patients with severe bleeding after car accidents, explosions, gunshot wounds or aortic dissections, etc. need immediate care because of the life-threatening blood loss. Both open and endovascular interventions are possible in a hybrid operating room. For example, the tension in the brain caused by heavy bleeding can be reduced and the aneurysm can be coiled . The procedure of bringing the emergency patient to the operating room as soon as possible after arriving at the hospital and, if the condition is stable, performing a trauma scan in the CT or, if the condition is unstable, starting the procedure directly in the hybrid operating room without having to transfer the patient to another bed. can save valuable time.

Imaging technology

Imaging with a fixed C-arm (angiography system)

Fluoroscopy and Acquisition

Fluoroscopy is 2D imaging using continuous X-rays to track the movement of catheters and other instruments in the body in real-time images. In order to depict even fine anatomical structures and instruments, a high quality image is necessary. In cardiac interventions in particular, imaging of the beating heart requires high frame rates (30 fps, 50 Hz) and high electrical voltage (at least 80 kV). These image quality requirements for cardiological applications are only met by fixed angiography systems, not mobile C-arms.

Angiography systems offer a so-called acquisition mode, which automatically saves the recordings in the imaging system so that they can later be transferred to an archive. While fluoroscopy is mainly used to guide instruments and select the image section, acquisition is carried out for diagnostic purposes. Especially when contrast agent is injected, the image must be recorded in acquisition mode, since the stored scenes can be played back as often as necessary without having to inject contrast agent again. In order to achieve sufficient image quality for diagnosis and documentation, the angiography system uses up to ten times more X-rays for acquisition than for fluoroscopy. Therefore, the acquisition mode should only be selected if the gain in image quality is absolutely necessary. It serves as the basis for more sophisticated imaging techniques such as DSA and rotational angiography.

Rotational angiography

Rotational angiography is a technique for intraoperative acquisition of CT-like 3D images with a fixed C-arm. For this, the C-arm describes a rotation around the patient during which it acquires a series of projections and reconstructs a volume data set from these.

Digital subtraction angiography

Digital subtraction angiography (DSA) is a two-dimensional imaging technique used to visualize blood vessels in the human body. To carry out a DSA, the same sequence of a projection is recorded with and without contrast agent injection into the vessels to be examined. The first image is then subtracted from the second to remove background structures such as bones as completely as possible. As a result, the contrast medium-filled vessels are shown more clearly. The time delay between the two recordings makes the use of motion correction algorithms necessary to minimize artifacts. An advanced application of the DSA is so-called roadmapping. The image with the maximum opacity of the vessels is identified from a recorded DSA scene and set as a roadmap mask. This is continuously subtracted from the real-time fluoroscopy, so that subtracted fluoroscopic images can be produced in real time and superimposed on the static image of the vessels. The clinical benefit consists in the improved display of fine and complex vascular structures without disturbing imaging of the surrounding tissue to support the placement of catheters and wires.

2D / 3D registration

Fusion imaging and 2D / 3D overlay

Modern angiography systems are not only used for diagnostic imaging, they also support the surgeon during the procedure on the basis of pre- or perioperatively acquired 3D information. Such an intraoperative orientation aid requires registration of the 3D information with the patient using special software algorithms.

Information flow between the workstation and the angiography system

3D images are calculated from a series of projections that are recorded during a rotation of the C-arm around the patient. The volume reconstruction is carried out by a workstation that is separate from the imaging system. The C-arm imaging system and the workstation are linked and communicate continuously. For example, if the user virtually rotates the 3D volume on the workstation in order to view the anatomy from a different perspective, the parameters of this view can be transferred to the angiography system so that the C-arm takes the exact position required for the selected view is used for fluoroscopy. Likewise, a change in the C-arm angulation can be transmitted to the workstation, the view of the 3D volume is then adapted to the current projection of the fluoroscopy. The underlying software algorithm is called “registration” and can also be carried out with DICOM data from other modalities, such as preoperative computed tomography or magnetic resonance tomography recordings.

Superimposition of 3D information and 2D fluoroscopy

The 3D volume itself can be color-coded and overlaid with the fluoroscopy. Every change in the C-arm angulation results in the view of the 3D volume being precisely adapted to the real-time 2D image. Without an additional injection of contrast medium, the surgeon can see the vascular structure while following the movement of his instruments in real-time fluoroscopy. Another way to add additional information from the workstation to the real-time image is to superimpose the contours of the previously segmented anatomy. Some of the available software applications automatically add markings for anatomical landmarks, others can be added manually by the surgeon or a qualified medical technician. An example of this approach is the implantation of a fenestrated stent graft to treat an abdominal aortic aneurysm. The branches of the renal arteries can be marked manually on the 3D volume on the workstation and this marking can then be superimposed on the fluoroscopy. Because the marking was done in three dimensions, it is adapted to every change in the projection.

Orientation aids for TAVI

The catheter-based replacement of the aortic valve ( TAVI ) requires the precise positioning of the prosthesis in the aortic root for the prevention of complications. A good fluoroscopic projection is essential, and an exactly right-angled plan view of the aortic root is considered the optimal angulation for the implantation. Software applications that support the surgeon in selecting the correct projection and move the C-arm into the exact position work with pre- or intraoperatively acquired 3D volumes. Intraoperative images have advantages in terms of the precision of the registration, in particular due to the patient positioning during the CT scan, which changes the anatomy. The use of a rotational angiography helps to reduce errors here.

Functional imaging in the operating room

Improvements in C-arm technologies now enable perfusion imaging and the display of blood volume in the operating room. For this purpose, rotational angiography is combined with a modified injection protocol and a special reconstruction algorithm. The blood flow over time can be displayed. This can be useful for treating patients with ischemic stroke.

Imaging using computed tomography

A rail-mounted CT can be brought into the operating room to support complex procedures such as spinal, brain and trauma surgery. The Johns Hopkins Bayview Medical Center in Maryland said using a CT intraoperatively in their home had positive effects on clinical outcome by increasing safety, reducing the risk of infection and reducing the risk of complications.

Magnetic resonance imaging

Magnetic resonance tomography is used in neurosurgery as intraoperative imaging:

  1. before the procedure for precise planning
  2. during the procedure to support treatment decisions and to show the brain shift
  3. after the procedure to evaluate the result.

An MRI takes up a lot of space in the room and makes it difficult to access the patient. Surgical interventions cannot be performed in a normal MRI room. For the second step, there are two solutions for using an MRI intraoperatively. The first is a moving MR that is brought into the operating room as soon as imaging is needed. The second is to transport the patient to an MR scanner in an adjacent room during the procedure.

Planning considerations

Location and organizational integration of the hall

Not only the use of the room is a “hybrid”, but also the role within the hospital system. Due to the imaging modality, the room could fall within the area of ​​responsibility of the radiology department, as it has the necessary expertise in terms of operation, technical questions, maintenance and connection to information systems. For workflow aspects, however, the room could also be the responsibility of the surgery and be located close to the other operating theaters in order to keep transport routes short and ensure patient-friendly care. Here every hospital has to find an individual solution adapted to the planned use.

Architecture of space

The installation of a hybrid operating room is a challenge for the usual room sizes in hospitals. Not only the imaging unit requires additional space. There are also more staff working in a hybrid OR than in a normal OR. A team of 8 to 20 people, consisting of anesthetists, surgeons, OR nurses, MTAs, cardio technicians and support staff from implant manufacturers, etc. can work in an OR. Depending on the imaging unit selected, an area of ​​up to 70 m² is recommended, including a control room, but without additional space for technology cabinets and patient preparation. Structural changes such as lead cladding of 2 to 3 mm for radiation protection and a possible reinforcement of the ceiling or floor to take into account the additional weight of the imaging system (approx. 650–1800 kg) may be necessary.

Workflow

The planning of a hybrid operating theater requires all future stakeholders of the room to be included in order to obtain a comprehensive overview of the requirements of all groups of people who work in, with and on the room. These will determine the design of the room, i.e. H. how much space is required and which technical components are selected. Professional project management and several planning loops with the producers of the imaging systems are necessary to take the complex technical dependencies into account. The result is always an individual solution, adapted to the needs and preferences of the team and the hospital.

Lighting, monitors and ceiling supply units

Two types of light sources are required in an operating theater: lamps to illuminate the surgical field for open procedures and ambient light for interventional procedures. The ability to dim the light during fluoroscopy or endoscopy is particularly important. The surgical lights must sufficiently illuminate the entire area above the operating table. For positioning, the head height of the staff must remain free and a collision with other ceiling-bound components must be avoided. The most frequently chosen position is in the middle above the operating table. If another position is chosen, the lamps often have to be brought in on articulated arms from outside the operating table area. The range of motion of the C-arm also influences the positioning; crossing the motion paths should be avoided. These components often also have precise room height requirements. The lighting thus becomes a critical component in the planning process. Other aspects that need to be taken into account when planning lighting include avoiding shine and reflections on surfaces. Modern operating theater lights offer additional functions such as built-in cameras that must be taken into account when wiring the monitors.

Imaging system

The most common imaging modality in the hybrid operating room is an angiography system, i.e. a fixed C-arm. Experts rate the performance of mobile C-arms as inadequate, as the image quality and the field of view are poor and, due to the cooling system, there is a risk of overheating during long interventions.

Fixed C-arms do not have these restrictions, but take up more space in the OR. They are available as ground-based or ceiling-mounted systems as well as biplane systems. The latter version is used in electrophysiology and pediatric cardiology. In other cases, in which there is no clear clinical requirement for two levels, the installation of such a system is not recommended, as it takes up a lot of space around the patient and the parts connected to the ceiling can cause hygienic problems. In some hospitals it is forbidden to install ceiling-mounted components directly above the operating field, as dust can fall into the wound and cause infections. Since ceiling-bound C-arms have moving parts above the operating field and impede the TAV flow, they are not the right choice for hospitals that are oriented towards the highest hygiene standards.

Another aspect to be considered when choosing between floor and ceiling-supported systems is the installation density on the ceiling. The system competes here with monitors and ceiling supply units. One advantage is the head-to-toe coverage of the patient without moving the table, which is often a dangerous undertaking given the tubing and catheters. Moving out of the parking and working positions, on the other hand, is easier with floor-based systems, as the C-arm moves in from the side and does not affect the anesthetist. Ceiling-supported systems can hardly drive to a head-side parking position without collision. Biplane systems add to the complication and disrupt the anesthesia, with the exception of neurosurgery, where the anesthetist does not assume a head-side position. The clear recommendation is therefore to install a monoplanar system if the room is not primarily used for neurosurgery.

Operating table

The position of the table in the room influences the work processes in the OR. A diagonal position creates space and flexibility and enables patient access from all sides.

The choice of operating table depends on the primary use of the system. There is a choice of intervention tables, as are common for angiography systems, with a free-floating tabletop as well as lateral and vertical tilting and integrated regular operating tables. A compromise has to be found between interventional and surgical applications. Surgeons are used to a segmented tabletop, which allows flexible positioning of the patient, especially in orthopedics and neurosurgery. A radiolucent table is required for imaging, which allows imaging from head to toe (overhang). Unsegmented carbon plates are used for this. Interventional cardiologists and radiologists need free-floating tabletops in order to be able to follow the contrast medium flow quickly and precisely. Cardiovascular surgeons usually have no special requirements for patient positioning, but out of habit they often prefer intervention tables with fully motorized table movements. Aids are available for positioning patients on unsegmented tabletops, such as: B. inflatable pillows. Free-floating tabletops are not available for regular operating tables. As a compromise, free-swimming interventionists with special tilting functions are recommended for the OR. Rails for attaching surgical accessories make these tables also suitable for operating theaters.

The combination of an angiography system with a regular operating table requires technical integration on the part of the manufacturer. In such a case, you can switch between a radiolucent, unsegmented plate that allows 3D imaging and a segmented plate for extended storage options (but limited 3D options). The latter option is particularly suitable for orthopedic and neurosurgery or when both hybrid and conventional procedures are to be performed in the room. The table tops can be undocked and exchanged using a shuttle, so such a table system is more flexible. However, metal components limit the possibilities for artifact-free imaging. In summary, when choosing the table, the room layout, the radiation permeability of the table top and the compatibility with the angiography system must be taken into account. Weight capacity, mobility of the tabletop (height adjustability, horizontal mobility, tilting functionality). and required accessories must be considered.

Radiation protection

X-rays are ionizing radiation and therefore potentially harmful. Compared to a mobile C-arm, which is very common in surgery, CT scanners and angio systems have much higher voltage levels and thus higher radiation emissions. This also causes the better image quality. It is therefore very important to monitor radiation exposure with staff and patients in the hybrid operating room.

There are some simple but effective measures to protect OR staff from scattered radiation and thus reduce their exposure. Awareness of the presence and dangers of radiation is essential here, otherwise the available protective measures could be carelessly ignored. Since staff who are not necessarily used to dealing with radiation work in the hybrid operating room, educational work and awareness-raising are required here. Protective clothing in the form of a lead apron, larynx protector and glasses are available as protective measures. Ceiling-mounted lead glass on articulated arms can be moved flexibly between the surgeon and the system. Additional lead curtains can be mounted on the table side to protect the lower body regions. The control room with the workstation is separated from the operating room by a lead glass pane so that employees can stay here without protective clothing. Particularly strict protective measures must be taken for pregnant employees. As a rule, once the pregnancy becomes known, they are no longer allowed to enter the room.

The most effective way of reducing the exposure of staff and patients to radiation is of course to use less radiation. There is a trade-off between radiation protection and image quality, which can improve the outcome of the procedure. Modern software can improve the image quality within the scope of post-processing so that a constant level can be achieved with a lower radiation dose. The image quality is defined by contrast, noise and artifacts. In general, the ALARA principle should be followed (as low as reasonably achievable, dt. “As little as possible”). The dose should be as low as possible, but a loss in image quality can only be tolerated to the extent that the diagnostic benefit of the imaging is even greater than the risk to the patient.

Further technical developments of the systems also lower the dose (example: radiation curing), or give the user the option of doing this depending on the clinical application, including changing settings such as image frequency, pulsed fluoroscopy and collimation.

Radiation curing: X-rays consist of hard and soft particles, i.e. particles with high energy and particles with low energy. Unnecessary radiation exposure is often caused by the soft, low-energy particles that are too weak to penetrate the body and reach the detector, thus contributing to image quality. So they get “stuck” in the body. In contrast, high-energy particles penetrate the patient and contribute to the generation of the image when they hit the detector. A filter on the X-ray tube can intercept the soft particles and thus harden the radiation as a whole. This dose reduction has no effect on the image quality.

Image frequency: High image frequencies, i.e. more images per second that are recorded, are necessary in order to display fast movements without a stroboscopic effect. The higher the frame rate, the higher the dose. The frame rate should, however, be selected as low as possible depending on the clinical application. In pediatric cardiology, for example, a frame rate of 60 fps is used, while 0.5 fps is completely sufficient for slowly moving objects. Reducing the frame rate by half also reduces the dose by about half. A reduction from 30 fps to 7.5 fps results in 75% less radiation.

In the pulsed fluoroscopy mode, radiation is only emitted at specified time intervals, not continuously. So less radiation is used to record the same scene. In the time between the pulses, the last picture taken is displayed.

Another tool for dose reduction is collimation. Only a small part of the field of view offered by the detector may be of interest to the procedure. Unnecessary image sections can be masked out using movable lead shields in the detector to save radiation. Modern C-arms also allow navigation based on stored images without permanent fluoroscopy.

Individual evidence

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  34. ↑ Fluoroscopy. (No longer available online.) In: IAEA Radiation Protection of Patients. Archived from the original on February 18, 2011 ; Retrieved March 12, 2013 . Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. @1@ 2Template: Webachiv / IABot / rpop.iaea.org