Download Dr Mzoneli - Hybrid operatingTheatres

20 July 2011
No. 24
HYBRID OPERATING THEATRES:
Are they necessary?
YLTN Mzoneli
Commentator: P. Gokal
Moderator: Dr M Soni
Department of Anaesthetics
CONTENTS
INTRODUCTION ................................................................................................... 3
WHAT IS A HYBRID OPERATING SUITE? ......................................................... 3
CLINICAL APPLICATIONS OF HYBRID THEATRES ......................................... 3
Paediatric and congenital cardiac disease ..................................................... 3
Coronary revascularisation ............................................................................. 5
Transcatheter heart valve replacement .......................................................... 6
Major vascular surgery .................................................................................... 8
Neuroradiology ................................................................................................. 9
SURGICAL INTERVENTIONS DONE AT INKOSI ALBERT LUTHULI HOSPITAL ..... 10
PLANNING A HYBRID OPERATING SUITE ...................................................... 10
BASICS OF HYBRID OPERATING THEATRE .................................................. 11
Location and design....................................................................................... 11
Imaging Equipment ........................................................................................ 12
Intravascular ultrasound (IVUS) ............................................................................. 13
Monitor screens ....................................................................................................... 13
SPECIAL CONSIDERATIONS OF WORKING IN A HYBRID THEATRE ........... 13
CONCLUSION .................................................................................................... 15
REFERENCES.................................................................................................... 16
Page 2 of 17
HYBRID OPERATING THEATRE: Are they necessary?
INTRODUCTION
The rapid advances over the past decade in technology and computerised
systems have greatly facilitated the development of minimal invasive techniques
in surgery. These complex minimally invasive image-guided procedures require
highly specialized radiology equipment to visualize thin wires, make
measurements of small calibre vessels, evaluate delicate anastomoses and
deploy implants but the facilities to convert to an open procedure are mandatory.[1]
The increasing number of these challenging endovascular and percutaneous
cases imply that the total number of open conversions may rise either due to the
technical impossibility of doing a closed procedure or due to complications.
Given the speed and extent of changes seen in surgery it is essential that
planning for surgical services must keep pace and adapt, capitalizing on the
emerging technological advances to produce the best possible outcomes for
patients. This was the reason for the conception of hybrid operating theatres in the
late 1990’s. [2; 8]
The role of the anaesthesiologist is not only to provide appropriate anaesthesia to
allow surgery but also to ensure patient safety by being in the appropriate
environment which will facilitate prompt and effective management of any
complication that may arise. This talk will introduce the concept; the need; design;
function and procedures done in these new hybrid suites.
WHAT IS A HYBRID OPERATING SUITE?
A hybrid suite is an operating theatre with imaging equipment equivalent to the
one used in an angiography suite or cardiac catheterisation laboratory. They serve
as multifunctional rooms designed to support a variety of catheter-based
endovascular interventions and open surgery to be performed in the same
location. These are high-technological facilities with special design, size, and
equipment usually managed by multidisciplinary teams. [2; 26; 27]
CLINICAL APPLICATIONS OF HYBRID THEATRES
Paediatric and congenital cardiac disease
Hybrid theatres were probably first inspired by paediatric congenital heart disease
management, although presently the strongest driver for this facility is
transcatheter cardiac valve replacement. [1] The management of neonates with
complex cardiac malformations like hypoplastic left heart syndrome (HLHS) and
Page 3 of 17
critical left ventricular outlet obstruction associated with borderline left ventricle
continues to be a great challenge with high morbidity and mortality.[6; 8]
Although open surgery remains the treatment of choice for most congenital
cardiac lesions, interventional techniques are increasingly being used as a bridge
to definitive repair or even at times for definitive procedure.
The use of catheter-based procedures which are less invasive in the neonatal
period allow the managing team to buy time for the infant to grow to an age and
weight appropriate for the “big” complex definitive surgery. The neonate is safely
managed for the stage I palliative procedure in a hybrid room where an off pump
small open procedure combined with a transcatheter technique is performed with
much less morbidity by the multidisciplinary team comprising of the cardiologist,
cardiothoracic surgeon and anaesthetist.[3; 5]
Before the recent development of the new transcatheter-surgical strategies the
neonate with HLHS the only option was the Norwood operation alternatively now
the neonate initially undergoes a Stage I palliative procedure which will later be
followed by a staged procedure to create a Fontan circulation. [5; 8]
The Stage I procedure entails the following: see the illustration in fig 1
a. Percutanous PDA stent to provide a reliable systemic cardiac output
b. Bilateral pulmonary artery banding to control and protect pulmonary blood
flow
c. Balloon atrial septoplasty to create an unobstructed flow from LA
PA banding
PDA stent
septoplasty
Fig 1 Stage I palliative procedure [8]
A number of ASD and VSD lesions are amenable to transvenous closures with
specifically designed septal occluders where a child is back at home in a day or
two post intervention.
Page 4 of 17
Another important benefit of hybrid suites in congenital heart defects management
is the availability of on table angiography and catheterization for intraoperative
assessment of the newly created anatomy. Holzer et al 2009 reported a 56%
incidence rate of unexpected anomalies of the pulmonary and coronary arteries
which required surgical revision in their case series of infants who underwent
corrective cardiac surgery with this imaging modality.[7] This together with
intraoperative transoesophageal echo prevents unnecessary re-do procedures.
The figure below shows an intra-operative angiography post Fontan to evaluate
the superior and inferior vena cava, the stented pulmonary arteries and pulmonary
circulation in a child born with HLHS.
Fig 2 Ohio Nationwide childrens hospital
Coronary revascularisation
An increasing burden of coronary artery disease in South Africa means there will
be a great demand for coronary revascularization in the near future. Zhao et al
2009 advocates routine on-table completion angiography for bypass grafts and
anastomosis evaluation following CABG. In their study they found angiographic
defects in 12% of patients who underwent CABG. These defects included conduit
poor lie, kinking, dissection, stenosis at the anastomosis, wrong anastomosis site
and even wrong vessel anastomosis. [9; 28]
“In virtually every reconstructive procedure in medicine and surgery the team will
take a before and after picture e.g. CVP line, orthopaedics but for CABG we do
not take an after picture which is perhaps one of the most important reconstruction
any human will ever have in their entire life” said John Byrne. [9]
The new surgical environment has fostered development of a number of
cardiovascular surgical procedures like minimally invasive techniques for CABG
off-pump, hybrid CABG and PCI and totally endoscopic coronary artery bypass
(TECAB). The dilemma of whether to do CABG or carotid endarterectomy (CEA)
Page 5 of 17
in a staged manner or same setting is partially answered by performing CABG
and carotid artery stenting in these ‘one stop shops’ for some patients.[10]
Transcatheter heart valve replacement
The concept of transcatheter replacement of cardiac valves is rapidly growing
since the first human percutaneous aortic valve replacement by Cribier in 2002. [15]
The transcatheter valve therapies are being developed for all the heart valves
including aortic, mitral, tricuspid and the pulmonary which is already established in
the paediatric population.[1]
Tricuspid valve catheter-facilitated implantations are described for degenerative
bioprosthetic valves, by doing valve-in-valve implantation. The mortality rate with
redo open tricuspid valve replacement is reported to be as high as 27% hence the
percutaneous approach is preferred. Stellenbosch University (2011) published a
case report of percutaneous tricuspid valve replacement in a patient with tricuspid
bioprosthesis stenosis, NYHA III, and a logistic EuroSCORE II of 8% which was
successfully performed in a catheterisation theatre with bypass back-up. [12]
Transcatheter aortic valve implantation (TAVI) for stenosis has been the one
throughout the world to revolutionalise cardiovascular care in the past decade.
There has been more than 15 000 TAVI’s done at present globally with more
being performed each day. South Africa also has 3 TAVI teams based in
Johannesburg, Durban and Cape Town at Netcare hospitals. The Cape Town
team has recently published their initial experience with TAVI. They reported a
procedural success rate of 97% with only 2 peri-procedural deaths and a 30 day
mortality of 7.1% compared to 26% as predicted by the EuroSCORE in their
cohort of 70 patients between Oct 2009 and July 2011.[14]
Transcatheter aortic valve implantation seems a viable alternative for patients
considered high risk as per EuroSCORE > 20 for conventional open surgery.
There are two aortic valve prosthetic systems which have CE-mark approval for
this procedure, both undergoing investigation:
1. The Edwards-Sapien valve balloon expandable from Edwards Lifesciences
2. The CoreValve Revalving system self-expandable from Medtronic
Fig 3a Edwards valve [32]
Fig 3b Medtronic valve
Page 6 of 17
The different approaches used for aortic valve replacement are: retrograde
transarterially or antegrade via the apex: [11]




Transfemoral (fig 4)
Transapical (fig 5)
Transaxillary / transbrachial
Transaortic
Fig 4
Fig 5
The anaesthetic issues are that these patients are much sicker and elderly with
much increased peri-operative risk compared to patients suitable for open
surgery. [22] The other concerns are: minimal access to the patient during the
procedure, an immobile patient and periods of apnoea required for optimal
imaging. The anaesthetist has to manipulate the cardiac output to facilitate correct
deployment of the valve usually by employing rapid ventricular pacing. Renal
protection against contrast nephropathy is important. [13; 19; 22]
This minimally invasive technique offers a number of potential benefits
 No need for a sternotomy.
 No need for cardiac arrest and cardiopulmonary bypass and its deleterious
effects.
 Reduced ICU stay.
 Reduced peri-operative morbidity and mortality.[14; 15 ; 23]
It is inherently associated with a number of complications listed below
 Vascular access damage (rupture, dissection, perforation)
 Embolisation of aortic atheromas resulting in neurological deficit.
 Cardiac perforation and dysrrythmias.
 Poor recovery of cardiac function after rapid ventricular pacing.
 Device malposition and embolisation.
 Hemorrhage and ventricular tear from transapical approach.[30]

Performing transcatheter valve therapies in a conventional theatre with a C-arm or
in a cath-lab is essentially a compromise because they were designed long before
these new procedures even existed. The hybrid operating suite is the ideal place
to perform these cases.
Page 7 of 17
Major vascular surgery
There has been a paradigm shift in the management of vascular diseases from
open surgical repair to new percutaneous endovascular interventions with good
early outcomes. The degenerative abdominal aortic aneurysms for the aged with
multiple co-morbidities are routinely treated endovascularly. Stanford type B aortic
dissection is also managed with endovascular stenting.
The figure below illustrates an aortic stent with bypass reconstruction for upper
circulation without the need of cardiopulmonary bypass machine. [15; 19]
Fig 6 The endoluminal aortic arch grafting debranching of the great vessels
[15]
The method of choice for the repair of blunt traumatic aortic injuries (BTAI) has
changed from exclusively open techniques to predominantly endovascular repair.
Comparing the clinical practices in two prospective observational multicenter
studies by American Association for Surgery of Trauma completed in 1997
(AAST1) and another completed in 2007(AAST2) it is evident that image guided
techniques are surpassing open surgery. In the AAST2, 65% were managed by
stenting and they had significant reduction in early mortality rate, paraplegia rate,
transfusion requirements and multiorgan dysfunction. [16; 17]
See table below:
OPEN REPAIR
Clamp & sew
On bypass
ENDOVASCULAR
AAST1 N=207 (%)
207 (100%)
73 (35.3%)
134 (64.7%)
0
Comparing methods of thoracic aortic repair (table 1) [16]
Page 8 of 17
AAST2 N=193 (%)
68 (35.2%)
11 (16.2%)
57 (83.8%)
125 (64.8%)
Patients in extremis and those treated non-operatively were excluded
Thoracic endovascular aortic repair (TEVAR) is minimally invasive, does not
require aortic cross clamping or one lung ventilation. It only requires special skills,
expertise and high resolution imaging for correct placement of the stent. Another
vital consideration is that BTAI’s are highly morbid injuries and are almost always
associated with multisystem injuries: thoracic & extrathoracic hence these patients
will require theatre to treat concomitant injuries and then transfer to angio suite for
stenting which exposes a polytrauma patient to unnecessary risks. [15; 19]
More and above, what happens if a guide-wire accidentally perforates a thoracic
aorta in the angiography suite? The best location would be an adaptable hybrid
theatre for comprehensive and safe management.
Neuroradiology
Many neurosurgical pathologies are now being managed by interventional
catheter based techniques. Our neurosurgical department at IALCH is following in
the steps of this worldwide growing practice. The technological advancements are
fostering treatment of even more complex, previously inoperable lesions on high
risk patients.
Evidence from International Subarachnoid Aneurysm Trial (ISAT) is suggesting
that there is better outcome with coiling of cerebral aneurysms compared to
craniotomy and clipping. There are numerous examples of neuroradiological
procedures broadly grouped into occluding and opening procedures. [20]
a) Occluding procedures
 Embolisation of arterio-venous malformations
 Aneurysm stenting or coiling
 Pre-resection embolisation of vascular tumours
 Embolisation of zone III traumatic carotid lesions
b) Opening procedures
 Stenting and angioplasty for cerebral atherosclerosis
 Thrombolysis of acute thromboembolic stroke
Neuroanaesthetists are faced with challenges of keeping a patient immobile,
appropriately anticoagulated, manipulation of hemodynamics like rendering short
periods of hypotension to produce “flow arrest” through the AVM and enable the
embolising material (solid or glue) to set rather than be carried straight through the
draining venous system with undesirable results.
The anaesthetist also has to be vigilant to detect procedural complications, for
timeous management especially haemorrhage from aneurysmal spontaneous
rupture or perforation, and intracranial vessel injury and dissection which may
need an emergency craniotomy and clipping to prevent patient from
exsanguinating to death. [21]
Page 9 of 17
SURGICAL INTERVENTIONS DONE AT INKOSI ALBERT LUTHULI HOSPITAL
The list below shows a summary of procedures done and case load at IALCH that
would ideally be performed in a hybrid theatre. If our cardiothoracic unit were to
adopt the Vanderbilt practice of doing on table ‘check angiography’ at the end of
CABG [9], it is clear that a hybrid facility at our institution will function at full
capacity.
PROCEDURE
EVAR
TEVAR
Carotid artery stenting
Neurovascular intervention
Brain tumour embolisation
ASD with septal occluder
VSD with septal occluder
NUMBER OF CASES
61
14
35
29
18
9
10
PERIOD
2008 – June 2012
2008 – June 2012
2008 – June 2012
2010 – June 2012
2012 – June 2012
2011
2010
Surgical activities at Inkosi Albert Luthuli (table 2)
EVAR:abdominal endovascular repair, TEVAR:thoracic endovascular repair,
ASD:atrial septal defect, VSD:ventricular septal defect
PLANNING A HYBRID OPERATING SUITE
Every hybrid operating room project planning requires a multidisciplinary approach
by identifying and bringing all stakeholders together. The team planning this
complex suite should have representatives from hospital administration,
engineering, architects, nursing, radiology, anaesthesia, perfusionists,
interventional cardiology, various surgical disciplines namely vascular,
neurosurgery and cardiothoracic. [2; 27]
A projected plan of all currently performed and anticipated procedures for the
hybrid room should be outlined so as to cater for needs of different surgical
specialities. These high technology rooms will cost almost double what a
conventional theatre costs therefore they must be considered only for major
specialist teaching and referral centres [4], especially in South Africa where health
resources are limited. Currently there are 3 international companies that design
hybrid OR’s: Siemens, Phillips and Toshiba.
Page 10 of 17
BASICS OF HYBRID OPERATING THEATRE
Location and design
A hybrid room should be ideally located in a theatre complex in order to keep the
logistics simple. The hybrid theatre needs to be larger than a standard theatre,
experts opinion suggest 70-80m2, excluding the scrubroom, control room, prep
room and technical room it should add up to 110-150m2 .
The large space is needed to accommodate for imaging equipment, a large
number of ancillary equipment and staff which could range from 8-15 people. [3]
The walls must be lined with 2-3mm of lead for radiation safety. Careful
deliberations in designing the ceiling is crucial with all the ceiling mounted
components, lights, laminar flow, ensuring that it is reinforced and there won’t be
collisions of flat display screens, operating lights and C-arm. [3; 28]
The planning of the floor layout is one of the most complicated endeavours with
the objectives of utilising the space optimally, ensuring safety by having good
access and clear walkways as well as improving the theatre workflow in the
presence of a large number of equipment pieces and personnel. The design must
enable a clear floor, optimised cable handling for cleaning and avoiding tripping
hazards. Equipment and devices need to be compact, easy to position and park
for flexible ergonomics for various procedures and disciplines. [3; 28; 31]
The schematic diagram below shows a floor layout for a vascular procedure and
note that different cases will have different set-up.
Fig 7 [19]
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A: anaesthetist 1: primary surgeon 2: assistant surgeon T: theatre sister
N: radiographer
This abbreviated list of equipment needed in this dual-capability theatre
environment to illustrate how congested it may be:
 Anaesthetic machine and all patient monitors
 Fluoro-capable table: to accommodate both percutanous and open
surgery
 3-D transoesophageal echocardiography machine
 Intravascular ultrasound (IVUS)
 Cardiopulmonary bypass machine
 Defibrillator with pacing capabilities
 Intraaortic balloon pump
 Cellsaver
 Electrocautery
 Contrast injector
 Surgical and catheter trolleys [25; 28; 29]
Imaging Equipment
Technical specifications as per ACC 2012 standards for imaging equipment
recommend fixed systems with high power output of ≥ 100kW to visualise thin
guidewires (0.2mm) and stents even in obese patients and to quantify small
vessel stenosis. The C-arm can be either floor or ceiling mounted with each option
having its own advantages and disadvantages.[31]
The decision whether to have a monoplane or biplane system will depend on the
main type of surgery done and projected to be performed in this dual suite. The
biplane system is recommended for paediatric cardiology, electrophysiology and
neuroradiology procedures whereas vascular and cardiac procedures a
monoplane system suffices. [28]
Monoplane vs Biplane System
Fig 8 from www.Siemens.com/healthcare
Page 12 of 17
Modern fixed C-arms are capable of sophisticated imaging techniques:





Simple 2-D fluoroscopy
3-D rotational angiography
CT-like 3D images
Digital subtraction angiography(DSA)
Functional imaging like flow analysis [29]
Fluoroscopy devices have now replaced the image intensifiers with digital flat
panel detectors which enable fluoroscopy to give higher image quality and
transition into 3D producing CT like images. This 3D C-arm computed tomography
is a new and innovative imaging technique. It uses 2D x-ray projections acquired
with a flat panel detector system to generate CT like images as the C-arm sweeps
around the patient and then performs 3D reconstruction. The surgeon is allowed
to navigate in 3-D anatomy with even better precision. [28; 31]
Digital subtraction angiography combined with road mapping is a non-dispensable
modality used in neuroradiology for complex and small vasculature for better
visualization.
Intravascular ultrasound (IVUS)
The explosion of the endovascular revolution has placed new demands on
accurate intra-operative imaging to obtain precise aortic measurements for
EVAR’s. IVUS also provides important qualitative information on luminal
morphology including the presence of atheromatous plaques, calcifications and
thrombus. It uses a miniature ultrasound transducer mounted on the tip of
catheters available in different sizes to suite various vessel diameters. [18]
Monitor screens
The display flat screens are divided into those that project the screened images
and those that show vital signs and hemodynamic parameters of the patient.
These monitor screens have to be strategically positioned such that there is no
interference with adequate view and to avoid collision with operating lights and
moving C-arm. [28]
SPECIAL CONSIDERATIONS OF WORKING IN A HYBRID THEATRE
A hybrid theatre is an unfamiliar environment to most anaesthetist. It is usually
cluttered with equipment and there is limited access to the patient, especially
because of the C-arm. Working in this setting where there is constant exposure to
radiation requires a fair knowledge of radiation protective measures. Therefore an
experienced anaesthetist with good understanding of the environment and
procedures is crucial. [13]
Page 13 of 17
Fig 9 The TAVI team at Panorama Mediclinic in Cape Town [14]
The patient population is different, they are usually older, sicker many with
significant co-morbidities hence the choice of a minimally invasive procedure. The
limited patient access demands special considerations with respect to airway
management, breathing circuits, monitoring leads and intravenous line
connections which need to be longer to ensure that they do not disconnect during
C-arm manipulation.
The suite is generally cold to prevent overheating of the C-arm, therefore
temperature monitoring and use of warming devices to avoid patient hypothermia
is important. Most procedures require anticoagulation aiming for ACT>240sec
using heparin and in the event of hemorrhagic complication reversal with
protamine may be needed. The anaesthetist has to facilitate optimal imaging by
rendering a patient immobile and may even have to suspend ventilation. [20; 21]
Various hemodynamic manipulations are needed to make the correct positioning
of the stents possible. To allow slowing of blood flow through brain AVM nidus and
enough time for the embolic material to set without the embolising agent
penetrating the draining veins, passing into the systemic circulation and embolise
to the normal brain tissue. [20] Thoracic aortic stenting and transcatheter aortic
valve replacement pose a great challenge because this is a high pressure and
high flow area.
The methods of hemodynamic manoeuvres to facilitate accurate device
deployment can be pharmacological or mechanical. Pharmacologic agents could
be rapid, short-acting IV antihypertensives or adenosine. Mechanical manoeuvre
usually entails establishing a transvenous pacer which will be used to induce
Page 14 of 17
short-lived rapid pacing. [21; 22; 24] All these hemodynamic manipulations must be
done without adverse neurologic, cardiac and systemic sequel. [19]
Vigilant approach during the procedures to detect complications is vital. Due to the
use of contrast, the anaesthetist has to consider renal protection from contrast
induced nephropathy by ensuring adequate volume status and administration of
N-acetylcysteine.
The hybrid theatre has a number of challenges unique to it particularly if a
procedure requiring expertise from different disciplines is performed eg TAVI. The
team usually comprises of many members that don’t always work together thus it
is crucial to have excellent communication and introduction with role clarification
which will help in an emergency. A collaborative convergence patient-centric
approach amongst team members is fundamental to achieve the best
outcomes.[4;25]
CONCLUSION
Given the advances in cardiac, vascular, neurologic and general surgery that
continue to drive for minimally invasive procedures which are image guided over
the traditional open surgical techniques clearly demands for a new operative
environment. The majority of these minimally invasive procedures are best
performed in a location with dual capability to do both percutaneous and open
surgery efficiently and safely.
This specialised theatre that combines the best of the two worlds is a hybrid
operating suite which offers great flexibility and clinical advantages. To appreciate
the value of a hybrid theatre one has to ask themselves a question ‘what would
happen if during a routine transcatheter procedure an important vessel perforates
in the angiography suite’.
However these facilities are very expensive hence it is imperative for an institution
planning to build one, to analyze its existing interventional caseloads and
anticipated future volumes to ascertain the need for a hybrid theatre. Another vital
consideration is how do we balance offering high technology, best quality and
state of the art health care as well as efficient primary health care services in a
country with limited resources like South Africa?
Page 15 of 17
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